The Limits to Governance

THE LIMITS TO GOVERNANCE This book is dedicated to long-suffering partners Richard Jackaman, Barbara Suarez and Barba...

Author: Catherine Lyall | James Smith

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THE LIMITS TO GOVERNANCE

This book is dedicated to long-suffering partners Richard Jackaman, Barbara Suarez and Barbara Bompani

The Limits to Governance The Challenge of Policy-making for the New Life Sciences

CATHERINE LYALL University of Edinburgh, UK THEO PAPAIOANNOU The Open University, UK JAMES SMITH University of Edinburgh, UK

© Catherine Lyall, Theo Papaioannou and James Smith 2009 All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without the prior permission of the publisher. Catherine Lyall, Theo Papaioannou and James Smith have asserted their right under the Copyright, Designs and Patents Act, 1988, to be identified as the editors of this work. Published by Ashgate Publishing Limited Wey Court East Union Road Farnham Surrey GU9 7PT England

Ashgate Publishing Company Suite 420 101 Cherry Street Burlington, VT 05401-4405 USA

www.ashgate.com British Library Cataloguing in Publication Data The limits to governance : the challenge of policy-making for the new life sciences. 1. Life sciences--Government policy. 2. Science and state. I. Lyall, Catherine. II. Papaioannou, Theo. III. Smith, James. 338.9'26-dc22 Library of Congress Library of Congress Control Number: 2009924913

ISBN 978-0-7546-7508-2 EISBN 978-0-7546-9842-5 (EBk.V)

Contents

Figure Notes on Contributors Foreword Preface and Acknowledgements 1

The Challenge of Policy-making for the New Life Sciences Catherine Lyall, Theo Papaioannou and James Smith

vii ix xiii xv 1

PART 1 Principles 2

Governance and Justice: The Challenge of Genomics Theo Papaioannou

3

The Roles of Values and Interests in the Governance of the Life Sciences: Learning Lessons from the ‘Ethics+’ Approach of UK Biobank Graeme Laurie, Ann Bruce and Catherine Lyall

4

Governing Reproductive Treatment and Research: From the Moral to the Political to the Legal – and Back Again? Or ‘There and Back Again, a Regulator’s (Hobbit’s) Odyssey (Holiday)’ Shawn H.E. Harmon

21

51

79

PART 2 Processes 5 6

Evolution along the Government-Governance Continuum: Impacts of Regulation on Medicines Innovation in the United States Christopher-Paul Milne and Joyce Tait

Governments and the Governance of Bioscience as a ‘New Security Challenge’ Paul Nightingale and Caitríona McLeish

7

Biosciences, ‘Development’ and the Abstraction of Governance James Smith

107

133 153

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8

The Limits to Governance

Ever-changing Policy Context: the One Stable Threat to Biotech Governance in Africa? Julius Tazvishaya Mugwagwa

171

PART 3 People 9 10 11 12

Advocacy Groups as Research Organizations: Novel Approaches in Research Governance Nadja Kanellopoulou

193

Non-governmental Limits: Governing Biotechnology from Europe to Africa Matthew Harsh

217

Deliberative Governance: Political Fad or a Vision of Empowerment? Peter Bryant

239

Governance in Action in the Life Sciences: Some Lessons for Policy Catherine Lyall, Theo Papaioannou and James Smith

261

Index

275

Figure

1.1

Instruments of governance

6

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Notes on Contributors

Ann Bruce is a Senior Research Fellow at the ESRC Innogen Centre, University of Edinburgh. Much of her research relates to interests and values in stakeholder interactions in areas of genomics and in this context she has studied human stem cell research, GM crops, biobanks and genomic applications to farm animals (genetic modification and cloning). She also has a particular interest in the conduct of interdisciplinary research. Ann has worked in industry, NGO and research institute, as well as university, contexts. Peter Bryant is a freelance advisor, facilitator and researcher. Specializing in participatory and deliberative forms of governance, he has worked widely in the UK, the rest of Europe and Africa. Most of his time is spent working with community groups, NGOs and local authorities on approaches such as citizens’ juries, participatory budgeting and participatory learning and action. Most recently in the UK he has worked with a group of young people on a European citizens’ panel on the future of rural areas as well as the citizens’ inquiry on the national DNA database. He is Vice Chair of the campaign group the World Development Movement. Shawn H.E. Harmon is a Research Fellow at the ESRC Innogen Centre and AHRC SCRIPT Centre, both at the University of Edinburgh. In addition, he is the Principal Investigator on an ESRC-funded project entitled ‘Governing Emerging Technologies: Social Values and Stem Cell Governance in Argentina’, and he is Editor-in-Chief of SCRIPTed: A Journal of Law, Technology and Society. His research interests encompass medical and medical research governance, biotechnological innovation governance, and international intellectual property policies and their influence on innovation. Matthew Harsh is currently a Postdoctoral Associate at the Consortium for Science, Policy and Outcomes and the Center for Nanotechnology in Society at Arizona State University. Much of his research focuses on how decisions about emerging technologies are made in Africa. A Marshall Scholar, he holds a BSc in materials science and engineering from Northwestern University and an MSc and PhD in science and technology studies from the University of Edinburgh. His work can be found in the Journal of International Development and Science and Public Policy. Nadja Kanellopoulou is a Postdoctoral Researcher in Law at the Ethox Centre, University of Oxford. She specialises in medical law, ethics and intellectual property with particular interest in the governance of individual and group

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identity. She holds an LLB (Athens), an LLM on Medical Jurisprudence and a PhD on Group Rights in Biolaw (School of Law/AHRC SCRIPT, Edinburgh). She was previously a Research Fellow at the ESRC Genomics Policy and Research Forum, also at University of Edinburgh. Her current work focuses on legal and regulatory aspects of privacy and consent in the protection of personal data (EnCoRe project). Graeme Laurie is Professor of Medical Jurisprudence in the School of Law at the University of Edinburgh and Director of SCRIPT, the Arts and Humanities Research Council Research Centre for Studies in Intellectual Property and Technology Law, also in the University of Edinburgh. Catherine Lyall is Deputy Director of the ESRC Innogen Centre at the University of Edinburgh. Her research and professional practice seek to advance an understanding of problems of science and technology policy formation and strategic decision-making by adopting interdisciplinary and practitioner-based perspectives. Her interests also span research evaluation (particularly in the context of strategic change and knowledge exchange) and the promotion and management of interdisciplinary research. She has acted as a consultant to a number of public bodies including the Economic and Social Research Council, Scottish Funding Council, Scottish Government, European Commission, and the League of European Research Universities. Caitríona McLeish is a Fellow at SPRU Science and Technology Policy Research at the University of Sussex. Since 1996 she has been attached to the Harvard Sussex Program on Chemical and Biological Weapons where she has undertaken projects on the governance of dual use technologies in both the chemical and biological warfare environments, conducted assessments of the impact that dual use control policies are having on the scientific and industrial communities and performed historical research on past offensive programmes. Christopher-Paul Milne is formerly a practising veterinarian. He later attended Johns Hopkins University where he earned a master’s degree in public health with a concentration in epidemiology and health statistics. He worked for the New Jersey Department of Health in risk assessment and regulatory review. In 1998, he graduated from law school and joined the Tufts Center for the Study of Drug Development (Tufts CSDD) as a Senior Research Fellow to address legal and regulatory issues that affect the R&D of new drugs and biologicals. He is a past member of the editorial board for the journal of the Drug Information Association (DIA) and now serves as the R&D Strategies Track Chair for the DIA’s Annual Meeting. He is currently Associate Director of the Tufts CSDD and an Honorary Fellow at the ESRC Innogen Centre, University of Edinburgh.

Notes on Contributors

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Julius Tazvishaya Mugwagwa received undergraduate and postgraduate training in biological sciences and biotechnology in Zimbabwe before attaining a PhD in biotechnology policy at the Open University, looking at cross-national convergence/harmonization of biosafety systems in southern Africa. He has worked extensively on science and technology issues in subSaharan Africa. He is currently based at the ESRC Innogen Centre, Open University as a Research Fellow. Paul Nightingale is a Senior Research Fellow at SPRU Science and Technology Policy Research, University of Sussex. He is formerly a chemist who worked as an environmental toxins analyst. He has a PhD and MSc from SRPU where he has been working as a full time researcher since 1996. His research interests include innovation policy, arms control, risk management and improving democratic control over the direction of innovation. He has a particular interest in the social distribution of the risks and rewards of innovation in finance and biotechnology. Theo Papaioannou is Lecturer in Innovation and Politics of Development at the ESRC Innogen Centre and the Department of Development Policy and Practice (DPP) at the Open University. He is also Research Director of the Innovation and Knowledge and Development Centre (IKD) at the Open University. He has researched and published extensively in the areas of public policy and political theory. His current research interests include: democratic governance of life sciences innovation; genomics and social justice; intellectual property rights and morality; ethico-political foundations of innovation and development. His recent publications include articles in Genomics, Society and Policy, International Political Science Review and Journal of Global Ethics. James Smith is Director of developing country research in the ESRC Innogen Centre. He is also a Director of the Centre of African Studies and of the Edinburgh International Development Centre at the University of Edinburgh. He has wide experience of studying the relationship between science, technology and development. He has worked in South Asia and Latin America and particularly in Africa and has experience working with donors, non-governmental organizations and governments. His recent publications include Development Matters: Science and Development (Zed Books) and Governing Biotechnology in Africa (ACTS Press). Joyce Tait CBE is Scientific Adviser to the ESRC Innogen Centre and a professor at the University of Edinburgh. She has an interdisciplinary background in natural and social sciences covering: technology development strategies in the chemical and life science industries; translational medicine; governance, risk assessment and regulation; policy analysis; stakeholder attitudes and influences; science and risk communication. She is a Fellow of

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the Royal Society of Edinburgh and also of the Society for Risk Analysis. Appointments include membership of the Board of Directors, Scottish Stem Cell Network Ltd; the Governing Council of the Roslin Institute; the Scottish Science Advisory Committee; the Scientific and Technical Council of the International Risk Governance Council.

Foreword Joyce Tait

This volume is an important component of the output from the first phase of the ESRC Innogen Centre. It builds on the concepts and insights developed for an earlier volume, New Modes of Governance,1 and extends these insights more specifically than before into the life science area. It brings together many aspects of our interdisciplinary research programme which integrates three key research constituencies: • scientists, medical professionals and industry managers developing life science research and technology; • policy makers and regulators, involved either in promoting science and innovation or in regulating its products; and • citizens’ and advocacy groups with concerns, either positive or negative, about the implications of the technology. While each of these three constituencies is considered to a greater or lesser extent in the discussion of principles, processes and people that follows, the book’s primary focus is on the second of these groups: policy makers and regulators. Their role is changing in response to fast-evolving life science research, the new knowledge that it is generating and the new development opportunities it presents. From scientists in universities, who are trying to generate new knowledge or who want to see that knowledge translated into useful (and often profitable) products, to multinational companies looking to stock existing pipelines with viable new products or even to generate new pipelines, regulation looms large on their horizons. This is the government component of the relationship. However, the governance aspects of relationships among the three constituencies outlined above are also important for all involved in life science developments. Increasingly, the actual outcomes of the huge public and private investments in basic science are moderated by the attitudes, values and interests of a wide range of citizens and their representative groups, from NGOs to industry lobby groups and their roles in the governance of the life sciences are also discussed in the chapters that follow. This book builds a series of interdisciplinary analyses on the basis of ideas and perspectives from social science disciplines that have led recent thinking on 1 Lyall, C. and Tait, J. (2005) (eds) New Modes of Governance. Developing an Integrated Policy Approach to Science, Technology, Risk and the Environment (Aldershot: Ashgate).

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new governance agendas. However, these agendas have been developed mainly in non-life science contexts; the first phase of the ESRC Innogen Centre’s research from 2002–2007 has shown that such insights can rarely be translated simplistically over to life sciences. The overlapping government/governance trajectory acquires new degrees of complexity in a scientific and industry context where the regulatory time-scale is greater than 10 years, costs more than $500 million, where market choices are usually not made by individual citizens, and where the nature of the science, itself, along with the products to which it gives rise are often publicly contentious. This complexity indeed raises questions about the value and appropriateness of different models of the government/governance relationship where the shift towards more governance-based approaches in the latter part of the twentieth century can be seen as the accretion of new forms of oversight to an industry sector that was already bearing a heavy regulatory burden. The governance-based approach was promoted in a spirit of optimism as a means to achieve more democratic and more robust political processes and decisions, distributing power more equitably across societal groups. However, in many of the cases described here, the outcome has been greater complexity which has acted to create a different sort of democratic deficit – a shift in the locus of the power base without a corresponding improvement in the responsibility with which that power is exercised. Government, in the form of regulation, is usually recognized as one factor among the many that combine to determine which products are developed, which companies are able to develop them and generate profits, and even which countries are able to support such profitable industries. Given its function to ensure that products are safe and effective, regulation has always been part of the background in economic and other analyses – a relatively static, non-variant component to be factored in to the overall equation. However, another strand of Innogen’s research programme has identified regulation, along with the increasing governance overlay, as the key factor determining the shape, location and profitability of research and development activity in the life sciences. Thus, whether we see the government/governance relationship as a hypothetical continuum as posited at the start of the book or as a more complex model of synchrony, we have by no means solved all of the problems that this new mode of governance set out to address, nor have we avoided creating some new ones. This examination of what limits the success of policy-making is a very timely development, addressing the continuing need for much more creative approaches by the social sciences to the governance challenges raised by the life sciences in developed and developing countries. The ESRC Innogen Centre’s Phase 2 research programme to 2012 is focusing on the future governance of the life sciences themselves and of associated opportunities, including the need for constructive change in the governance, government and regulatory approaches to meet the needs of future innovation in areas such as synthetic biology and stem cell therapies, as well as ongoing developments in pharmaceutical innovation.

Preface and Acknowledgements

This book is one result of the synergy that has occurred among a number of research projects conducted by the ESRC Centre for Social and Economic Research on Innovation in Genomics (‘the ESRC Innogen Centre’) based in the UK at the University of Edinburgh and the Open University. The Innogen Centre was established in 2002 with funding from the UK Economic and Social Research Council (ESRC) (ESRC grant numbers RES 145-28-1004 and RES 145-28-0002). We acknowledge this financial support and also that of our respective universities in the preparation of this book. We also wish to acknowledge financial assistance provided by the Brocher Foundation (www. brocher.ch). This support has enabled us to bring together a unique grouping of colleagues at various stages of their academic careers, ranging from professors to senior PhD students, from across our multi-site and cross-departmental Centre, to work with us on this project. We are grateful for their support and patience in the production of this volume. We have also been joined in this endeavour by collaborators from two other renowned research centres at SPRU Science and Technology Policy Research, University of Sussex, UK and the Tufts Center for the Study of Drug Development, Boston, USA together with a user view from someone with an intimate knowledge of deliberative and participatory processes in Africa and the UK. These authors bring a welcome outsider’s perspective to the project. The research conducted by the ESRC Innogen Centre has involved many stakeholder groups as both research subjects and research partners. These range from policy-makers in Scotland, the UK, Europe and Africa as well as international bodies, civil society and patient groups, industry and regulators. Many of these actors are considered in the chapters that follow. This book therefore exemplifies the breadth and reach of the Innogen research community and represents a substantial body of ongoing research which will continue to grow in the coming years. Our starting point for this publication was a recognition that the multifaceted policy and regulatory situation that applies to the life sciences presents a paradox: at the core of the problem lies the fact that the life sciences do still require a considerable degree of government-led regulation which runs counter to the prevailing shift towards decentralized governance. This apparent paradox provided a focal point around which many of the Centre’s research projects were able to converge in order to examine and debate empirical evidence with the intention of advancing both theory and policy and practice in this relatively nascent field of study.

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As researchers from a range of disciplines who have been working on these issues over a number of years, we feel that it is essential to promote critical, interdisciplinary discussion on the governance of the life sciences from a range of perspectives, not simply as an academic exercise but in order to facilitate understanding, knowledge exchange and decision-making amongst a number of interested parties, ranging from policy-makers to non-governmental organizations, whom we hope will form the audience for this book alongside our academic peers. In addition to the authors listed as contributors to this book, many of our other Innogen colleagues have played a role in this project through their involvement in discussions at various stages of the book’s evolution and we appreciate their input. Finally, two colleagues are deserving of special mention for their key roles in the production of this volume. We acknowledge with grateful thanks Moyra Forrest for her skilful indexing and Eileen Mothersole for her careful preparation of the manuscript. Catherine Lyall, Theo Papaioannou and James Smith

Chapter 1

The Challenge of Policy-making for the New Life Sciences Catherine Lyall, Theo Papaioannou and James Smith

Introduction Getting the governance of the life sciences ‘right’ is presenting policy-makers, nationally and internationally, with one of the challenges of the twenty-first century. Policy-makers must now deal with a crowded and diverse set of actors and are striving to engage meaningfully with civil society in order to deliver a policy environment that both captures the potential health, agricultural and developmental benefits in a way that meets the expectations of society and delivers economic competitive advantage. Biotechnology promises a great deal but has in many respects failed to deliver. Moreover, concerns about risks, ethics and the north-south dimensions of emergent biotechnologies and their implications pose new and complex policy questions. In a previous volume (Lyall and Tait 2005, 186) we suggested that we shall not understand how the governance of technology works or how it could work differently if we do not see the whole system. The social sciences have been very active and highly effective in exposing the defects of the government agenda of the 1980s and before. However, social science research has so far been less effective in reconciling these tensions in the new governance agenda. What the governance approach debated in our previous book has done is turn the spotlight on the need to develop strategies and procedures to help decision-makers to govern science, technology, risk and the environment in a way that makes best use of appropriate systemic analyses on the basis of the best available evidence from both social and natural sciences. We continue to believe that one of the biggest challenges in integrating the various elements of the new governance agenda is the potential incompatibility between evidencebased decision-making and greater stakeholder engagement. Policy decisions that are ostensibly science-based have always been influenced by interests and values. Wider stakeholder and public engagement inevitably leads to demands to bring a broader range of interests and values into consideration in these decisions. So far we have not learned to integrate stakeholder engagement in issues related to science and innovation in ways that do not undermine the role of evidence in decision-making or indeed make it redundant.

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The background to the themes discussed in the chapters that follow has been the emergence of new governance structures and policy processes in Europe and North America over the last two decades. This edited volume sets out to problematize conventional notions of governance and networks that attempt to foster participatory mechanisms when they are applied to policy for the life sciences. At the core of the problem lies the fact that the life sciences do still require a considerable degree of conventional command and control style regulation. As others have noted, despite the ‘frenzy’ surrounding the new modes of governance, much policy in Europe at least still relies on legislation (Eberlein and Kerwer 2004). In Africa and elsewhere in the ‘South’ the creation of formal regulatory systems has dominated policy- and decision-making (Clark et al. 2007). Others have written of ‘the resilience of regulation’ (Jordan et al. 2005), of ‘re-instating the centre’ (Marinetto 2003), and of the demise of policy networks as policy-making is brought back ‘in-house’ (Thompson 2003, 187). While Hagendijk and Irwin (2006) conclude that different forms of governance co-exist, their case studies suggest that bureaucratic structures ‘tend to subsume deliberative exercises within conventional processes, and return quickly to “business as usual”’. Is governance then just a neologism of the late twentieth and early twentyfirst century (Jordan et al. 2005)? The term has been applied to ‘everything from corporations to rural society’ (Sloat 2002) and the academic literature on the subject has been described as ‘eclectic and relatively disjointed’ (Stoker 1998). The meaning of the word is clearly contested and often lacks definitional clarity (Bache 2003); different disciplines within the social sciences appear to employ different interpretations (Kjær 2004, 1–7) and even within different branches of political science its use varies (Jordan et al. 2005). Many of the complicating factors identified in the application of the governance agenda to science and innovation-related issues therefore arise from complex interactions between the still-necessary, government based regulation and control and the main themes of the governance agenda, particularly the contrasting and sometimes incompatible requirements for policy decisions to be evidence-based and at the same time for a greater degree of stakeholder engagement in policy decision-making (Lyall and Tait 2005, 179). Although most commentators accept that ‘governance’ is no longer a synonym for ‘government’, it may be that, as governance is ultimately concerned with creating the conditions for ordered rule and collective action, its outputs are no different from those of government but what is significant is the difference in processes and the value of the governance perspective rests in its capacity to provide a framework for understanding changing processes of governing (Stoker 1998). The development of this new governance agenda has been debated in various academic disciplines, including institutional economics, international relations, organizational studies, development studies, political science, and public administration but often with different interpretations and emphases.

The Challenge of Policy-making for the New Life Sciences

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To date, the notion of ‘governance’ has been explored and tested much more thoroughly in policy contexts such as social policy and education but it is increasingly influential in the arena of science and innovation, most especially in the context of the life sciences. However, in these cases there has so far been much less critical academic debate and less guidance for, and experience of, their effective implementation in different areas of application. In this and many of the chapters that follow, we consider some of the ‘new tools of governance’ and how they might apply to the life science industries. We shall suggest that there are actually limits to the all pervasive notion of ‘governance’ and that, instead, the multifaceted policy and regulatory situation that applies to genomics and the life sciences more generally actually argues for the existence of a government-governance continuum with different aspects of genomics technologies sitting at different points on this spectrum. Despite the political (and academic) rhetoric about new governance approaches, we perceive the enduring capacity of the state (in the North at least) to control and also to frame debates about new technology – hence ‘the limits to governance’. In the global South the limits to governance are thrown into relief precisely by the limits of the state to control and lead debates surrounding new technologies. By placing government and governance at the opposite ends of a hypothetical continuum in this way we are not intending to set up a dichotomy between government and governance (Jordan et al. 2005; Pierre and Peters 2000, 29) but to consider how they exist as a duality, believing as do Jordan and his co-authors that government and governance are indeed irrevocably ‘intertwined’. We are thus setting out to examine different forms of mutual coexistence that are not always easy or comfortable but are, nevertheless, vitally important to the future of the life sciences. The Tools of Governance Most would accept that the term ‘governance’ refers essentially to the increased role of non-government actors in policy-making (Bache 2003). Some use the term to refer to ‘a pattern of rule characterized by networks that connect civil society and the state’ (Bevir et al. 2003a) and it is generally regarded as implying an increasingly complex set of state-society relationships in which networks, rather than hierarchies, dominate policy-making (Bache 2003). Thus, ‘governance’ is used as shorthand to describe the changing nature and role of the state in advanced societies and the changing boundary between state and civil society (Bevir et al. 2003b). In this approach, the role of the state changes from being the main provider of policy to one of facilitating interaction among various interests (Sloat 2002) so that government’s role is increasingly one of coordination and steering (Bache 2003). From a governance perspective the process of governing is an interactive one because no single

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actor has the knowledge and resource capacity to tackle problems unilaterally (Kooiman 1993). In summary, this perspective focuses on the coordination of multiple actors and institutions to debate, define and achieve policy goals such that the state no longer dominates the policy-making process and decisions are made by ‘problem solving rather than bargaining’ (Sloat 2002). Some argue that we have witnessed a revolution, not just in the scope and scale of government action, but in its ‘basic forms’ (Salamon 2002a, 1). New instruments have proliferated to tackle public policy issues. Examples of such instruments could include benchmarking, co-regulation, voluntary codes of conduct and negotiated agreements (Zito et al. 2003). Such instruments are often indirect, and may rely on third parties to deliver policy goals which have greatly expanded the range of actors involved in public policy. But the focus of much debate about the policy-making process remains on the concept of a centralized bureaucratic state (Salamon 2002a, 8). But policy networks – often seen as the embodiment of the governance approach – can both enhance and reduce the efficiency and legitimacy of policy-making (Borzel 1998). Indeed, Greenaway et al. (2007) challenge this assumption that the growth of networks leads to more democratic government. Such practices can be quite exclusive: consultations can enhance efficiency, but also diminish accountability, as compromises are negotiated between interested parties outside established political processes and institutions (Barry 2001 quoted in Hagendijk and Irwin 2006). Newman (2001, 66) suggests that states may have an interest in promoting policy networks because they ‘make policy-making predictable and reduce policy conflicts’. Others question whether the ‘enthusiastic endorsement’ of lay participation by political elites raises the question of whether initiatives are indeed intended to promote public engagement, or whether they represent a form of political marketing and persuasion (Hagendijk and Irwin 2006). Networks are often favoured for their positive attributes such as flexibility and responsiveness but policy networks and, in particular, policy communities (Rhodes 1997) can be regarded as a source of stability and continuity and hence policy inertia rather than a source of policy innovation (Rhodes and Marsh 1992). Effective network participation can depend on possessing technical capacity and detailed information and the exchange of information between state and private actors can create privileged relationships from which the uninitiated are excluded (Atkinson and Coleman 1992). This means that policy networks can be dominated by producer groups, professional groups and government (Rhodes and Marsh 1992) and can be viewed as a ‘clique’ by those excluded from the network (Hay and Richards 2000). Tensions can therefore arise between this depiction of networks as institutionally dense, cumbersome and slow moving and the new governance literature on networks as flexible and dynamic alliances. The choice of policy tools generally reflects political culture (Ringeling 2002, 597; Schneider and Ingram 1990). The need to involve particular actors


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may also determine which tool is chosen and such choices are shaped by cultural norms and ideological dispositions such that ‘a strong pro-market bias underlies tool choices in the United States … whereas western Europe is much more wary of the market and much more favourably inclined toward the state’ (Salamon 2002a, 11). Hagendijk and Irwin (2006) construct a typology of governance, where each of the six categories1 suggests different characteristics of governance in relation to scientific/technological policy but these authors note that the governance of science in Europe can best be described as a mixture of these modes where once again different countries follow different trajectories, shaped by their political cultures. As an example, we have seen these distinctions played out in different genomics-related contexts when we consider, for example, the different US and EU responses to stem cells and GM foods (Murphy and Chataway 2005). Moreover, tools are not used alone but in combination (depending on what is most appropriate for the context) so most systems of governance exhibit a mix of styles (6 2005; Ringeling 2002, 596). A range of different policy tools has been identified (often using different nomenclatures but with underlying similarities), including ‘authority; incentives; capacity-building; symbolic and hortatory; and learning (which may include participation tools)’ (Schneider and Ingram 1990); ‘control, inducement, influence and coping’ (6 2005); or ‘carrots, sticks and sermons’ (Bemelmans-Videc et al. 2003) (Figure 1.1). Tool choices are fundamentally political choices. As a result, the blending of tools is often ad hoc with ‘too little attention given to how tools might be optimally combined into truly integrated systems’ (Salamon 2002b, 602). As may become apparent in the following chapters, not only are we in danger of failing to effect an appropriate ‘blend’ when it comes to the governance of the life sciences, it appears that we may be caught between conflicting approaches. National and supra-national governments such as the European Union seek to use the life sciences industries as an engine for growth and international competitiveness and recognize the importance of engaging industry stakeholders in the development and implementation of policy in increasingly open forms of governance. The UK government has made ‘a clear commitment to make the UK the most hospitable place in the world to do scientific research’ (Forbes 2006 quoting DTI 2004, 9). But running contrary to this – in both the UK and the US – is a concern that the industry has become too influential and we are, at the same time, witnessing counter measures by government to reassert the tools of control via the pharmaceutical regulatory regime. We appear to be seeing evidence of greater industry involvement in policy-making (although one might argue that the evidence is simply more visible rather than that the involvement and interaction are actually greater). There are clearly tensions in this approach. For example, there are familiar 1 These six forms of governance are described respectively as ‘discretionary’, ‘corporatist’, ‘educational’, ‘market’, ‘agonistic’, and ‘deliberative’.

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Governance ‘Steering’

Hierarchy ‘Rowing’

Increasing degree of government coercion


Classification*

Examples

Sermons Influence Hortatory

Public information campaigns

Carrots Inducement Capacity- building Sticks Control Authority

Fiscal e.g. R&D tax incentives

Regulation

* Identified by Bemelmans-Videc et al. (2003); Schneider and Ingram (1990) and 6 (2005). The ‘steering not rowing’ terminology derives from Osborne and Gaebler (1992).

Figure 1.1 Instruments of governance and substantive concerns about the close identification of regulators with the interests of the regulated industry (e.g. Abraham et al. 1999; Abraham 2002; Ismail 2005) and problems of conflict of interest in research submitted to the regulatory agencies (e.g. Michaels and Wagner 2003; McComas et al. 2005). But, if we accept that good policy-making is about dialogue and that one of the characteristics of policy learning is a high level of participation in policy-making by stakeholders (Common 2004), what then is the legitimate role for the life science industries in the governance of genomics? As outlined below, a major incident in the US concerning post-approval drug safety had a significant impact on industry-government relations. Such concerns about the role of industry in the development of policy and regulation may encourage a return to hierarchical government and a backlash against the involvement of certain stakeholders in more participative forms of governance. Vioxx and the Challenge to Governance Chataway et al. (2006) describe how the remoteness of multi-national companies from any public consumer base, their global reach, their sometimes arrogant attitudes in response to public


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concerns, and the public perception that they are, in many cases, ‘beyond governance’ have contributed to the lack of public trust in both agrobiotechnology and pharmaceutical industry sectors.

This is exemplified in many ways by the Vioxx story. This was an incident where a blockbuster drug, manufactured by the company Merck, changed the way America regulates its drugs industry.2 Vioxx belongs to a class of anti-inflammatory drugs known as cox-2 inhibitors which are used to treat arthritis and chronic pain. Towards the end of 2004 evidence began to emerge which suggested that these drugs were implicated in increased heart risks. There had been safety questions surrounding Vioxx for some time and cardiovascular side-effects had been seen in earlier clinical trials. Merck voluntarily withdrew its product at the end of September 2004 and strenuously denied that it had manipulated safety data during the clinical trials phase. What was significant about this case was the impact that it had on the US Food and Drug Administration (FDA). Critics described the US drugs regulator as having ‘lethal weaknesses’ in its oversight mechanisms and of acting with ‘irresponsible self-interest’ (Richard Horton, editor of The Lancet quoted in Mitchell 2004). Others said that this was further evidence that the FDA was too friendly with industry. Even FDA insiders accepted publicly that pharmaceutical regulation in the US was ‘broken’ (David Graham, senior FDA official quoted in Bowe 2004a). Graham criticized the FDA systems where ‘the same group that approved the drug is also responsible for taking regulatory action against it post marketing. This is an inherent conflict of interest’ (David Graham, senior FDA official quoted in Bowe 2004a). Observers noted that the fall out from Vioxx could lead to calls for tougher regulatory standards including longer clinical trials (Bowe 2004b) and a separation of drug approval and safety monitoring roles within the FDA, a move opposed by the pharmaceutical industry (Firn 2004a). This was indeed what happened. The FDA was called before Congress; internal and external reviews were ordered to examine the agency’s drug safety procedures and, in particular, its post-approval monitoring system. And momentum built to make clinical trials public. The controversy deepened when it was alleged that the FDA was trying to discredit Graham (Firn 2004b) after he claimed that the agency’s bureaucratic hierarchy favoured drug makers and downplayed researchers with safety concerns (Bowe 2004c) because the FDA can only recommend post-marketing studies but has no power to enforce them, relying instead on a voluntary reporting system. There were calls for a ‘firewall to go up between FDA reviewers and industry’ (Marris 2004) and questions asked about whether the agency is compromised by the user fee model (Frantz 2005). 2 For a fuller account see Lyall (2007a).

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The Vioxx case raised fundamental questions about drug regulation in the US and the lack of separation between industry and the FDA as a whole. It exposed the US drug regulator to scrutiny by the media and politicians and raised questions about independence and regulatory capture. Contrary to the generally de-regulatory climate, US politicians demanded tighter controls to prevent conflict of interest and ensure greater transparency. Policy Challenges in the Governance of the Life Sciences In the life sciences, genomics-based technologies which are leading to the discovery of genomics-based therapeutics including small chemical pharmaceuticals, are having an impact on both technological and political regimes which is raising a number of questions about the policy-making process. In particular, the governance of genomics is not yet adequately addressed in existing or emerging institutional structures of policy-making resulting in a ‘gap between policy challenges and institutional responses that might lead to growing social opposition against genomics’ (Gottweis 2002). It may be the case that developments such as stem cells, genetic databanks and GM crops are evolving more rapidly than the relevant policy and regulatory systems, added to which the increasingly globally-based organization of research and innovation places further pressures for new modes of governance of science and technology (Tait et al. 2006, 379). With this new mode of governance, the boundaries between and within public and private sectors have become blurred and the role of the state changes from being the main provider of policy to one of facilitating interactions across a wide range of interests and values. This perspective thus focuses on the coordination of multiple actors and institutions to debate, define and achieve policy goals in complex political arenas (Sloat 2002) which may imply that there is now less reliance on coercive policy instruments and more on subtle techniques involving a restructuring of state institutions, creating new institutional forms that operate at a distance from control by the political elite. Ideally, managed appropriately, open decision-making should bring the advantages of better policy and better democracy but cynicism abounds about the extent of leverage that different types of stakeholders can exert and it is evident that access to policy-makers does not equate to impact. However, as Tait et al. (2006, 382) note, this highlights a tension in genomics-related industries where command and control style regulation is still necessary to control the safety and efficacy of new products. There is broad agreement that we need new modes of governance to cope with this increased level of complexity as well as new rules of engagement in the governance process for the various stakeholder groups involved (Chataway et al. 2006). Gottweis (2002) points to ‘the rise of the genomics industry as a powerful force in the genomics governance network’ and suggests that existing


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institutions are failing to deal adequately with the new regulatory issues raised by genomics. Much has been written recently about public engagement as a new tool of governance in the context of genomics. Some express concern that the main beneficiaries of this repositioning have been social scientists and not the lay public (Anon 2005) but the politicization of the life sciences has been uneven with most governance still in the form of traditional advisory structures (Lyall 2007b). The Vioxx-instigated events in the US coincided with a UK parliamentary watchdog’s findings that the regulatory system was failing to provide an effective regulatory regime to ensure that the industry works in the public interest (House of Commons Health Committee 2004). Both highlighted the unresolved tensions in the expectations that, through new governance approaches, policy-makers will simultaneously engage with a wider range of stakeholders; increasingly base their decisions on evidence; and be able to reconcile conflicting views of that evidence in order to deliver both greater transparency and intelligibility of new technologies to the wider publics and greater accountability of the main commercial producers and users of those technologies (Lyall 2007a; Lyall and Tait 2005, 183; Laurie et al. Chapter 3; 6 2005, 21). Difficulties clearly remain when attempting to reconcile the conflicting government priorities of innovation promotion and risk regulation within the life sciences and, consequently, the frictions that exist between a continuing need for ‘top-down’ regulation and the new ‘bottom-up’ initiatives in participative policy-making. There is undoubted value in industry and government working together in informal policy-making where, for example, in the area of biologics, the FDA has in the past been able to develop its regulatory framework through ‘discretion and informal policymaking’ (Bonnicksen 2002, 103) and the UK government has relied on the pharmaceutical industry to shore up the nation’s dismal industrial research record. But, in a study of UK government-industry taskforces, Lyall (2007a) suggests that politics can rapidly turn these mutual government-industry policy cooperations into a struggle over competing interests resulting in circumstances that would appear to be the very antithesis of the situation envisaged by the UK government when it sought to establish joint task forces to promote the industry. Salamon (2002a, 37) describes the result as the ‘paradox of third-party government’ where policy-makers seem to be under increasing political pressures to select those tools of public action that are the most difficult to manage and the hardest to keep focused on their public objectives. Indeed, many of these new tools of governance are horizontal (Ringeling 2002, 588-9) – communication/public information; networking; public-private partnership – and not based on a view of government controlling the actions of others. It has been suggested that technological change may negate old policy instruments and lead to the application of new ones (Hood 1986 quoted

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in Howlett 1991). But, if the range of tools available to solve public policy problems ‘has proliferated massively’ (Salamon 2002b, 601), does this actually hold true for the life science industries? In many other policy arenas we may indeed have seen a shift from tools of command and control to negotiation and persuasion (6 2005, 22; Salamon 2002a, 15–16); towards culture-building, influence and ‘steering’. But it is generally the case that the political sensitivity of the life sciences, and genomics in particular, requires deterrence rather than self-regulation. While much policy literature tends to assume that governance takes place without government (Kjaer 2004, 203–4), the cases discussed in the following chapters demonstrate the limits to governance and point to the notion of a government-governance continuum or duality (rather than a new tool of governance) where different aspects of genomics and life science technologies exemplify different models of this government-governance duality. The state endures. While greater transparency in clinical trials procedures which has been engendered by the Vioxx incident is unquestionably welcome, this has illustrated, not the ‘hollowing out’ process envisaged by the new governance agenda, but instead greater state control: an old control tool being re-applied rather than a new tool of governance. If viable governance systems do indeed depend on dialogue, the involvement of a requisite variety of institutions and the prevention of institutional polarization3 then there is an inherent danger in any backlash that results in the pendulum swinging too far from industry engagement in policy-making solely in favour of public engagement. It is worth bearing in mind that, when asked in a Eurobarometer survey (European Commission 2005, 43) whether different groups involved in science and technology had a positive effect on society, industry scored more highly than the regulators.4 As already noted, the emphasis on networks in the governance literature tends to ignore the continued importance of hierarchy: in the case of genomics and the life sciences, much of the current pan-European regulation reinforces this hierarchy (Mitchell 2005) and may, in turn, undermine networking processes (Davies 2005). The challenge for the future governance of the life sciences is thus to incorporate the most useful aspects of governance-based approaches and reconcile them with the still necessary systems of regulation in a way that does not exclude key stakeholders – such as the pharmaceutical industry – from the policy debate.

3 Contribution from Perri 6 to New Governance Tools for New Technologies?, ESRC Innogen Centre workshop 8 June 2005, University of Edinburgh. 4 EU25 average positive effect: scientists in industry doing research 85 per cent; industry developing new products 81 per cent; public authorities regulating science and technology 73 per cent.


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Aims and Structure of the Book The governance perspective might just be ‘a simplifying lens to a complex reality’ as far as academic researchers are concerned (Stoker 1998), but policymakers at all levels believe that improved participation in the policy-making process will create more confidence in the resulting policies and ensure more effective implementation. Together with our co-authors, we seek to explore the important ethical, legal, social and policy implications of this far-reaching technology5 which has the potential to have a significant impact on both wealth creation and the quality of life on a global scale. In so doing, we hope that our interdisciplinary approach will enable a range of other perspectives to be brought to bear on the subject including the relationship between innovation and regulation, the impact of the governance of the life sciences in developing countries and the contested role of stakeholders in participative governance. This book therefore offers a critique of the new governance agenda for science and innovation in the context of the life sciences, and particularly genomics. The ethical, legal, social and policy implications of the governance and regulation of the life sciences are far reaching. The cases discussed in this book will contrast the role of the state in controlling and framing the context for the implementation of innovations in life sciences (through the regulatory system) with the more participative forms of policy-making that are being fostered both to promote national competitiveness and encourage public acceptance of these new technologies. In the case of the life sciences, there can be real practical difficulties (and in some cases intractable conflicts), for example, when those industries being regulated and those participating in associative governance and policy-making involve virtually the same configurations of actors. In what follows, we present a mix of theoretical, empirical and case study approaches. In order to demonstrate the limits to governance at different levels the book is organized into three parts: principles, processes and people. Part 1 examines the relationship between morality and governance of the new life sciences innovation at the level of principles. In Chapter 2, Papaioannou opens the discussion by addressing the issue of governance and justice. Specifically, he asks whether the challenge of genomics in terms of fair distribution of opportunities and risks creates limits to governance. His answer is that heterarchical processes of governance as such are unable to promote and enforce certain principles of justice. Therefore, genomics-related injustices such as genetic discrimination, new forms of eugenics and social inequality cannot be institutionally dealt with in terms of heterarchical governance. Papaioannou concludes that only ‘joined up’ policies of government mediated by democratic 5 In this and the chapters that follow authors use the terms ‘life sciences’, ‘biosciences’, ‘biotechnology’ and ‘genomics’ relatively interchangeably to describe this technology.

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engagement of citizens can effectively respond to aggregate claims of justice. In Chapter 3, Laurie, Bruce and Lyall examine the role of moral values and interests in the governance of the life sciences. Their examination is grounded on the case of UK Biobank. The latter is characterized as an ‘Ethics+’ approach in the sense that its governance regime has been developed over and above existing regulation. Laurie, Bruce and Lyall argue that the case of UK Biobank points towards a model of ‘reflexive’ governance that is democratic and systematic in gathering evidence about the range of values and interests at stake, in exploring commonalities and differences and in developing policies acceptable to reasonable stakeholders. As such, the authors argue that, in the case of the UK Biobank, government and governance are not functioning as two poles of a continuum nor as two completely intertwined entities but as a ‘soft’ wrapping of governance around a ‘hard’ core of government. Harmon continues the discussion of ‘intertwined’ government and governance processes in Chapter 4 which focuses on the relationship between the moral, the political and the legal in the governance of reproductive treatment and research. In order to demonstrate this relationship, Harmon offers a brief case study of the process leading up to the Human Fertilisation and Embryology Act 1990 (HFEA 1990). Harmon argues that this act is an example of legitimate and morally alive legislation. Therefore, he concludes that, while the ultimate output was a legislative instrument, the process leading to HFEA 1990 constitutes a deliberative exercise closer to governance than government. Part 2 moves the debate on from the level of principles to the level of processes, investigating how the latter translate across developed and developing countries. This part of the book includes four empirical contributions. In Chapter 5, Milne and Tait focus on the evolution of processes along the government-governance continuum in the United States (US). Specifically, they examine the impacts of regulation on two US FDA programmes: the orphan product and fast track programmes for the development of new medicines. According to Milne and Tait, these programmes serve as useful models of a regulatory system, evolving a governance approach. However, old style command-and-control government has not disappeared. Rather, as Milne and Tait stress, government is still present but with more control and less command. In Chapter 6, Nightingale and McLeish examine the governmentgovernance continuum in the specific context of biosecurity processes in the United Kingdom (UK). They argue that it might be misleading to understand biosecurity policy problems as part of a shift from government to governance. Rather what appears to be a shift can be understood as a reconfiguration of security at the state level. Nightingale and McLeish conclude that changes in biosecurity policy of countries such as the UK highlight the limits to governance. In Chapter 7, Smith investigates governance processes in developing countries. His focus is on three cases: the impact of international rice research on the organization of subsequent international agricultural research; the politics of genetically modified (GM) food aid in Zambia; and the complex development


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of eflornithine drug for therapeutic needs in sub-Saharan Africa. According to Smith, these cases illustrate the absence of the state and the different slices of governance processes. Smith concludes that governance of technology for development is an abstraction that often fails to capture the ‘realpolitik’ of science and development and infrastructural inability of developing countries. In Chapter 8, Mugwagwa looks at biosafety governance processes in southern African countries. He argues that these processes involve not only actors such as multinational companies and non-governmental organizations (NGOs) but also governments. In the context of developing countries, the regulation of modern biotechnology presents a challenge because of country deficiencies and lack of substantial international cooperation. Mugwagwa concludes that in southern African countries, different resources and players are needed for facilitating the emergence of a successful cross-national governance framework, which has to include the political state command-and-control approach to regulation. Part 3 examines the limits to governance at the level of involvement of people. The three chapters in this section all address the same question in different contexts: who are the actors involved in the governance of new life sciences and what limits their involvement? In Chapter 9, Kanellopoulou looks at the role of advocacy organizations in the governance of genomic research. These organizations promote research in rare diseases, engaging large numbers of patient families. According to Kanellopoulou, this role has become increasingly important with such groups operating as gatekeepers for biomedical research activities and funding. However, there are limitations to contract-based models of advocacy since they do not help to resolve broader questions of equitable governance in research. Kanellopoulou concludes that a more systematic way is needed to examine and institutionalize effective governance models for group research. In Chapter 10, Harsh returns to the discussion of governance in Africa, taking as an example contemporary Kenya. He points out that in this specific developmental context, NGOs play a key role in the governance of biotechnology. However, there is a paradox that needs to be critically addressed: as more NGOs are involved in the governance of biotechnology in African countries things become less participatory. This paradox is illustrated in Harsh’s case study of Kenya that demonstrates that despite the number of NGOs involved, there are very few voices participating in biotechnology decisions, and a lack of clarity about who is representing whom. Therefore, Harsh concludes, more NGOs’ involvement does not necessarily lead to more participation and inclusion. Governance as such creates a more consensual picture of decision-making, even though there are significant problems with regard to equal access and democratic legitimacy. In Chapter 11, Bryant moves away from NGOs and discusses a case of direct involvement of people in the governance of biotechnology. Specifically, he looks at the role of farmers in deliberative processes of governance of genetically modified organisms (GMOs) in Mali. According to Bryant, this

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case illustrates that active participation and dialogue can have significant impact on biotechnology decision-making. Therefore, he concludes that deliberation may be one solution to the limits to governance of life sciences innovation. Finally, in Chapter 12, Lyall, Papaioannou and Smith concede that governance is a very slippery concept that cannot be easily evaluated. As far as the new life sciences innovation is concerned, governance does reflect a shift from government to heterarchical networks and non-political actors. However, the multifarious examples of governance in action presented by the preceding chapters demonstrate that this shift is normatively and empirically limited at the levels of principles, processes and people. Policy-making for the new life sciences can only take place effectively if it acknowledges these limits and recognizes that it must operate within the ‘government-governance continuum’, a complex world where government and governance co-exist in multiple, heterarchical forms. The final chapter offers some lessons for policy on the dynamic, political and context dependent nature of this co-existence. References 6, P. (2005), ‘The Governance of Technology’, in Lyall, C. and Tait, J. (eds) New Modes of Governance. Developing an Integrated Policy Approach to Science, Technology, Risk and the Environment (Aldershot: Ashgate). Abraham, J., Sheppard, J. and Reed, T. (1999), ‘Rethinking Transparency and Accountability in Medicines Regulation in the United Kingdom’, British Medical Journal 318, 46–7. Abraham, J. (2002), ‘The Pharmaceutical Industry as a Political Player’, The Lancet 360:9, 1498–502. Anon (2005), ‘When Disenchantment Leads to Disengagement’, Research Fortnight 26:January 2005, 18–19. Atkinson, M.M. and Coleman, W.D. (1992), ‘Policy Networks, Policy Communities and the Problems of Governance’, Governance: An International Journal of Policy and Administration 5:2, 154–80. Bache, I. (2003), ‘Governing through Governance: Education Policy Control under New Labour’, Political Studies 51:2, 300–314. Barry, A. (2001), Political Machines: Governing a Technological Society (London and New York: The Athlone Press). Bemelmans-Videc, M.L., Rist, R.C. and Vedung, E. (2003), Carrots, Sticks and Sermons: Policy Instruments and their Evaluation (New Brunswick, NJ: Transaction Publishers). Bevir, M., Rhodes, R.A.W. and Weller, P. (2003a), ‘Comparative Governance: Prospects and Lessons’, Public Administration 81:1, 191–210.


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Bevir, M., Rhodes, R.A.W. and Weller, P. (2003b), ‘Traditions of Governance: Interpreting the Changing Role of the Public Sector’, Public Administration 81:1, 1–17. Bonnicksen, A.L. (2002), Crafting a Cloning Policy. From Dolly to Stem Cells (Washington DC: Georgetown University Press). Borzel, T.A. (1998), ‘Organizing Babylon – on the Different Conceptions of Policy Networks’, Public Administration 76:Summer, 253–73. Bowe, C. (2004a), ‘FDA Expert Accuses Agency over Vioxx’, Financial Times. (London, 18 November 2004). Bowe, C. (2004b), ‘FDA Official Warns on More Drugs in Hearing’, Financial Times (London, 19 November 2004). Bowe, C. (2004c), ‘Safety Fears Plague US Drug System’, Financial Times (London, 25 November 2004). Chataway, J., Tait, J. and Wield, D. (2006), ‘The Governance of Agro- and Pharmaceutical Biotechnology Innovation: Public Policy and Industrial Strategy’, Technology Analysis and Strategic Management 18:2, 169–85. Clark, N., Mugabe, J. and Smith, J. (2007), Governing Biotechnology in Africa (Nairobi: African Centre of Technology Studies). Common, R. (2004), ‘Organisational Learning in a Political Environment. Improving Policy-making in UK Government’, Policy Studies 25:1, 35–49. Davies, J.S. (2005), ‘Local Governance and the Dialectics of Hierarchy, Market and Network’, Policy Studies 26:3/4, 311–35. DTI (2004), The DTI Five-year Programme. Creating Wealth from Knowledge (London: DTI/Pub 7613/0.5k/11/04/NP.URN 04/1871). Eberlein, B. and Kerwer, D. (2004), ‘New Governance in the European Union: A Theoretical Perspective’, Journal of Common Market Studies 42:1, 121–42. European Commission (2005), ‘Social Values, Science and Technology’, Special Eurobarometer Report (Brussels: June 2005) http://europa.eu.int/ comm/public_opinion/archives/ebs/ebs_225_report_en.pdf. Firn, D. (2004a), ‘Inquiry into Drug Companies Launched’, Financial Times (London: 10 September 2004). Firn, D. (2004b), ‘FDA Safety Official Complains of Intimidation over Vioxx’, Financial Times (London: 24 November 2004). Forbes, I. (2006), ‘States of Uncertainty: Governing the Empire of Biotechnology’, New Genetics and Society 25:1, 70–88. Frantz, S. (2005), ‘How to avoid another “Vioxx”’, Nature Reviews Drug Discovery 4, 5–7 (January 2005). Gottweis, H. (2002), ‘The Governance of Genomics’, Critical Public Health 12:3, 207–20. Greenaway, J., Salter, B. and Hart, S. (2007), ‘How Policy Networks Can Damage Democratic Health: A Case Study in the Government of Governance’, Public Administration 85:3, 717–38.

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Hagendijk, J. and Irwin, A. (2006), ‘Public Deliberation and Governance: Engaging with Science and Technology in Contemporary Europe’, Minerva 44:2, 167–84. Hay, C. and Richards, D. (2000), ‘The Tangled Webs of Westminster and Whitehall: The Discourse, Strategy and Practice of Networking within the British Core Executive’, Public Administration 78:1, 1–28. Hood, C. (1986), The Tools of Government (Chatham: Chatham House Publishers). House of Commons Health Committee (2004), The Influence of the Pharmaceutical Industry (London: House of Commons). Howlett, M. (1991), ‘Policy Instruments, Policy Styles, and Policy Implementation: National Approaches to Theories of Instrument Choice’, Policy Studies Journal 19:2, 1–21. Ismail, M.A. (2005), Drug Lobby Second to None July 2005 (Washington DC: Center for Public Integrity). Jordan, A., Wurzel, R.K.W. and Zito, A. (2005), ‘The Rise of “New” Policy Instruments in Comparative Perspective: Has Governance Eclipsed Government?’, Political Studies 53, 477–96. Kjaer, A.M. (2004), Governance (Cambridge: Polity). Kooiman, J. (1993), Modern Governance. New Government-Society Interactions (London: Sage). Lyall, C. (2007a), ‘Governing Genomics: New Governance Tools for New Technologies?’, Technology Analysis and Strategic Management 19:3, 365–82. Lyall, C. (2007b), ‘Changing Boundaries: The Role of Policy Networks in the Multi-level Governance of Science and Innovation in Scotland’, Science and Public Policy 34:1, 3–14. Lyall, C. and Tait, J.(2005), ‘A New Mode of Governance for Science, technology, Risk and the Environment?’, in Lyall, C. and Tait, J. (eds) New Modes of Governance. Developing an Integrated Policy Approach to Science, Technology, Risk and the Environment (Aldershot: Ashgate). Marinetto, M. (2003), ‘Governing beyond the Centre: A Critique of the Anglo-Governance School’, Political Studies 51:3, 592–608. Marris, E. (2004), ‘Suppressed Study Raises Spectre of Flawed Drug Regulation in US’, Nature 432, 537. McComas, K.A., Tuite, L.S. and Sherman, L.A. (2005), ‘Conflicted Scientists: The “Shared Pool” Dilemma of Scientific Advisory Committees’, Public Understanding of Science 14:3, 285–303. Michaels, D. and Wagner, W. (2003), ‘Disclosure in Regulatory Science’, Science 302, 2073. Mitchell, P. (2004), ‘“Self-interested” FDA Accepts Reform after Vioxx Fiasco’, Chemistry and Industry 22:4 (15 November 2004). Mitchell, P. (2005), ‘Europe Caught in Innovation Quagmire’, Nature Biotechnology 23:9, 1029.


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Murphy, J. and Chataway, J. (2005), ‘The Challenges of Policy Integration from an International Perspective: The Case of GMOs’, in Lyall, C. and Tait, J. (eds) New Modes of Governance. Developing an Integrated Policy Approach to Science, Technology, Risk and the Environment (Aldershot: Ashgate). Newman, J. (2001), Modernising Governance. New Labour, Policy and Society (London: Sage). Osborne, D. and Gaebler, T. (1992), Re-inventing Government (Reading, MA: Addison-Wesley). Pierre, J. and Peters, B.G. (2000), Governance, Politics and the State (Basingstoke: Macmillan). Rhodes, R.A.W. (1997), Understanding Governance. Policy Networks, Governance, Reflexivity and Accountability (Buckingham: Open University Press). Rhodes, R.A.W. and Marsh, D. (1992), ‘New Directions in the Study of Policy Networks’, European Journal of Political Research 21, 181–205. Ringeling, A.B. (2002), ‘European Experience with Tools of Government’, in Salamon, L.M. (ed.) The Tools of Government (New York: Oxford University Press). Salamon, L.M. (2002a), ‘The New Governance and the Tools of Public Action: An Introduction’, in Salamon, L.M. (ed.) The Tools of Government (New York: Oxford University Press). Salamon, L.M. (2002b), ‘The Tools Approach and the New Governance: Conclusion and Implications’, in Salamon, L.M. (ed.) The Tools of Government (New York: Oxford University Press). Schneider, A. and Ingram, H. (1990), ‘Behavioural Assumptions of Policy Tools’, Journal of Politics 52:2, 510–29. Sloat, A. (2002), ‘Governance: Contested Perceptions of Civic Participation’, Scottish Affairs 39:Spring, 103–17. Stoker, G. (1998), ‘Governance as Theory: Five Propositions’, International Social Science Journal 50:155, 17–28. Tait, J., Chataway, J., Lyall, C. and Wield, D. (2006), ‘Governance, Policy and Industry Strategies: Pharmaceuticals and Agro-biotechnology’, in Mazzucato, M. and Dosi, G. (eds) Innovation, Growth and Market Structure in High-tech Industries: The Case of Biotech-Pharmaceuticals (Cambridge: Cambridge University Press). Thompson, G.F. (2003), Between Hierarchies and Markets. The Logic and Limits of Network Forms of Organisation (Oxford: Oxford University Press). Zito, A.R., Radaelli, C.M. and Jordan, A. (2003), ‘Introduction to the Symposium on “New” Policy Instruments in the European Union’, Public Administration 81:3, 509–11.


PART 1 Principles


Chapter 2

Governance and Justice: The Challenge of Genomics Theo Papaioannou

Introduction Innovation in the new life sciences has in recent years offered the prospect of applications with profound impact on social and economic life. Especially in health care, the successful decoding of the human genome and subsequent advances of genomics-based technologies (including biotechnology) have enabled the development of cheaper and safer drugs, the introduction of new gene-based diagnostics and biomedical therapies. However, these new technologies have also raised concerns with regard to the issue of genetic discrimination, the rise of a new form of eugenics, and the problem of access to new genomic services. The so-called ‘genomic revolution’ does not benefit all equally and some have in fact already been disadvantaged by particular applications of genomicsbased technologies. For instance, the current use of in vitro fertilization (IVF) and pre-implantation genetic diagnosis (PGD) for the purpose of detecting chromosomal abnormalities or inherited genetic disorders have disadvantaged those who have no access to these technologies. The fairness of distribution of technological opportunities and risks is a matter of social justice and this is the main challenge of genomics to governance today where governance refers to the current shift from the formal institutions of government and the political state to a new style of governing through informal networks and nongovernmental actors. This chapter focuses on the relationship between governance and justice, addressing the following question: whether the challenge of genomics in terms of fair distribution of opportunities and risks creates limits to governance? It will be argued that the current gap between this challenge and institutional response is due to the inability of governance to deal with aggregate claims of social justice. In fact, only ‘joined up’ policies of government and the political state can effectively respond to these aggregate claims. The chapter is structured as follows: the next section investigates the problematical relationship between governance and justice, after which the focus moves to the challenge of genomics-based technologies to governance. The chapter then examines how this challenge can be effectively addressed in

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terms of justice before looking at the role of government and the political state in the just steering of genomics-based technologies. The final section concludes that today’s challenge of genomics creates such limits to governance that only government and the political state, mediated by democratic engagement of citizens, can overcome them through integrated or ‘joined-up’ policies. Governance and Justice The concept of governance emerged in the 1990s through a series of discussions about the role of political state in modern society (Jordan et al. 2005; Bache 2003; Rhodes 1997; Rosenau 1995; World Bank 1994). Since then, the issue has been that this role is under constant change and governments no longer find themselves able to cope with problems or deal with demands that are too numerous and too contradictory (Merrien 1998). Therefore, the political state must share its power with non-political agents, forming partnerships and networks with the private sector. This marks a shift from formal ‘commandand-control’ regulatory instruments (Jordan et al. 2005) towards informal processes through which non-political actors are gradually allowed to coordinate themselves. Jessop calls the new processes a ‘heterarchy’, arguing that ‘… its forms include self-organising interpersonal networks, negotiated inter-organisational co-ordination, and decentred context-mediated intersystemic steering’ (Jessop 1998, 29). Heterarchy is considered to be the only alternative process of legitimation to hierarchy of government. According to Pierre and Peters (2000, 15): Much of the current governance literature is dismissive of hierarchy as a model of governance. Hierarchies, critics contend, were an appropriate institutional order in the days of … domestically controlled markets and unrivalled state strength. With most of these factors profoundly altered, so must hierarchies fall, the argument goes.

This predominately society-centric argument of governance can also be implicitly or explicitly found in the works of theorists such as Downs and Larkey (1986), Kooiman (1993), Rhodes (1996, 1997), Stoker (1998) and Demers (1998). All of them conceive governance as a set of networks and social interactions rather than a political process of government institutions (Pierre and Peters 2000). Their argument is that society as such is capable of developing self-managing and self-organizing mechanisms in order to avoid the political state imposing its own hierarchical governance. Despite the enthusiasm of proponents of the society-centric approach to governance, it might be said that, in fact, heterarchy fails to serve society as a whole. Instead, it serves the fragmented interests of particular social groups and individuals, promoting their specific conceptions of the good. This increases

Governance and Justice: The Challenge of Genomics

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inequalities among citizens and regions. As Kazancigil (1998, 71) points out, governance is a process that ‘… is at its best in horizontal co-ordination partnership, negotiation, regulation, but not so good in responding to the need of aggregate demands’. To be sure, demands of justice are aggregate demands. Such demands are political and normative while governance, as conceived by its society-centric proponents, is more problem-solving than aggregating and overlooks certain political and normative issues. As Tait and Lyall (2005, 180) stress, the focus of modern governance is merely on ‘what works’. The inability of modern governance to respond to aggregate demands of justice can be theoretically illustrated in the relationship between heterarchical processes of steering society and principles of distributive justice. The latter can be found in different traditions of political theory which influence public policy (Cozzens 2007), including the new life sciences and technology policy (Mittra 2007a). Specifically, if one reviewed those traditions, one might first come up with five distinct sets of principles of distributive justice: egalitarian liberalism; libertarianism; utilitarianism; communitarianism; and Marxism. One might then theoretically examine whether each set of principles of distributive justice presupposes heterarchical processes of governance in order to promote and enforce its aggregate application in society. Egalitarian Liberal Principles This is a set of principles of justice at the centre of which is the liberal notion of equality. The latter refers to equal liberty of everyone in society. Representatives of the egalitarian liberal tradition such as John Rawls formally advanced equal liberty from a hypothetical original position of choice of fundamental principles of justice (Rawls 1972).1 These are the equal right to basic liberty and the so-called difference principle: • Each person has an equal right to the most extensive scheme of equal basic liberties compatible with similar scheme of liberties for all. • Social and economic inequalities are to satisfy two conditions: they must be (a) to the greatest benefit of the least advantaged members of society; and (b) attached to offices and positions open to all under conditions of fair equality of opportunity. (Rawls 1999, 362) 1 In order to achieve equal liberty, Rawls assumes his original position behind a veil of ignorance. According to him, in the original position ‘… no one knows his place in society, his class position or social status, nor does anyone know his fortune in the distribution of natural assets and abilities, his intelligence, strength and the like’ (1972, 12). Despite its arbitrary nature, Rawls’s hypothetical original position permits him to derive basic principles of justice as fairness. His argument is that in the original position all parties agree that equal liberty and the difference principle ought to guide social cooperation.

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The primary subject of Rawls’s principles of justice is the structure of society, the political governance of social institutions into one liberal scheme of cooperation (ibid., 54). In this cooperative scheme a distributive practice is fair or just when it satisfies the two fundamental principles which people mutually accepted in the original position. However, since the first publication of Rawls’s A Theory of Justice (1972), a number of critiques have consistently focused on the inadequacy of his arguments, advancing alternative theories of equalitarian justice. Among others, Thomas Scanlon (1982) proposed a version of justice as impartiality that was expounded by Brian Barry (1995). In their view, there is no need for a special theoretical device such as original position. Agents could be asked to give equal consideration to others despite their knowledge of their place in society as the basis of its institutions. As Barry puts it (ibid., 81–2) in a liberal society ‘… there are conflicting conceptions of the good and the object of justice as impartiality is to find some way of adjudicating between them that can be generally accepted as fair’. Other egalitarian liberals such as Ronald Dworkin (2002) advanced a more concrete theory of justice as an equal division of resources. In Dworkin’s theory, such a division takes the form of an auction between different individuals in the market. Specifically, an elected authority can ensure that everyone starts with an equal amount of resources (starting gate theory) and everyone uses his/her resources to bid for those goods that best suit his/her chosen way of life. The auction is successful if everyone is happy and they do not envy anyone else’s goods (Dworkin 2002, 67–71). Certainly, neither Dworkin and Rawls nor Scanlon and Barry presuppose in their theories bottom-up heterarchical processes of just governance. Rather they assume top-down regulatory processes through which the principles of justice can be formalized and universalized. Indeed, when it comes to justice, those theorists seem to agree that the ‘… dispersion of governance across multiple jurisdictions …’ (Marks and Hooghe 2004, 16) is not normatively superior to central state. Clearly, Dworkin, Rawls, Scanlon and Barry favour a central liberal state that intervenes in the market and governs the distribution of resources and welfare in accordance with formal principles of justice. Such interventions for the sake of social justice cannot be advanced through heterarchical processes of governance simply because it is only the political state that can guarantee them and not various self-organizing interpersonal networks. The latter are often chaotic with no common conception of the good. In fact, as Rhodes (1994, 147) warns us, self-organizing interpersonal networks are ‘a form of private government’ that increases complexity and decreases accountability. Libertarian Principles This is a set of principles of justice founded upon inviolable individual rights. Thus, according to Robert Nozick (1974, ix), ‘Individuals have rights, and


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there are things no person or group may do to them (without violating their rights)’. Libertarians insist that social distribution violates individual rights and especially the right to self-ownership e.g. ‘… every person is morally entitled to full private property in his person and powers. This means that each person has an extensive set of moral rights … over the use and fruits of his body and capacities …’ (Cohen and Graham 1990, 25). On the grounds of self-ownership and moral inviolability of persons, libertarians develop abstract principles of justice (Papaioannou 2008). For instance, Nozick (1974, 151) argues that ‘If the world was wholly just, the following inductive definition would exhaustively cover the subject of justice in holdings: • A person who acquires a holding in accordance with the principle of justice in acquisition is entitled to that holding. • A person who acquires a holding in accordance with the principle of justice in transfer, from someone else entitled to the holding, is entitled to the holding. • No one is entitled to a holding except by (repeated) applications of 1 and 2.’ Although it is true that Nozick’s principles of justice are consistent with heterarchical processes of governance, taking place in the free market, they presuppose a hierarchical minimal state apparatus to promote and enforce them, protecting individuals against force, theft and fraud. In Nozick’s theory, heterarchical processes of governance such as self-organizing networks and associations fail to provide universal protection. Thus, it is only the hierarchical minimal state that has monopoly over the use of force for the application of libertarian principles of justice. According to Nozick (1974, 149) ‘The minimal state is the most extensive state that can be justified. Any state more extensive violates people’s rights’. Utilitarian Principles Both egalitarian liberal and libertarian traditions can be seen as responses to utilitarianism. The latter claims that people ought to act in such a way that they maximize general happiness of the members of society. Utilitarianism is a consequentialist tradition of political morality. This means that: It demands of anyone who condemns something as morally wrong that they show who is wronged, e.g. they must show how someone’s life is made worse off. Likewise, consequentialism says that something is morally good only if it makes someone’s life better off. (Kymlicka 1990, 10)

Utilitarianism has many versions, including preference satisfaction and welfarist versions. However, in its hedonistic version advanced by Bentham

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(1970) and Mill (1937), utilitarianism conceives happiness as a sum of pleasures. Pleasure is morally good and pain is morally bad (Raphael 1994). As Dworkin (1977, 160) points out, utilitarianism is a goal-based theory concerned with the welfare or well-being of each individual. Therefore, this theory is competing with right-based theories of justice, including Rawls’s egalitarian liberalism and Nozick’s libertarianism. For utilitarians, rights are just legal obligations which contribute to maximization of the aggregate utility (Lyons 1984). Bentham (1970, 11–12) defines utility as the ‘… principle which approves or disapproves of every action whatsoever, according to the tendency which it appears to have augment or diminish the happiness of the party whose interest is in question …’. Although utility is considered to be an attractive principle of liberal justice (Kymlicka 1990), it is in opposition to the theory of governance that defends heterarchy and non-governmental processes of steering economy and society. This principle demands hierarchical state interventions for the sake of maximization of aggregate well-being. For this is reason, utility as such was the main guiding principle of the traditional welfare state. The latter was hierarchical, governing economy and society through top-down processes of political regulation. For instance, the traditional welfare state pursued full employment and redistributive welfare (Taylor-Gooby 1999) through governmental actors and agencies. Communitarian Principles This is a set of principles of justice which are founded upon the idea of selfdetermination. Communitarians argue that self-determination cannot be conceived in abstraction from pre-conditions created within the community (Papaioannou 2008). They stress that the liberal view of self-determination is individualistic and does not take into account the fact that people recognize themselves through their community. The communitarian idea of self-determination leads to politics of common good. The latter refers to a conception of the good life that self-determinant individuals define as their community’s ‘way of life’ (Kymlicka 1990). In this sense, each individual adopts his/her conception of the good that conforms to his/her community and depends on how much each individual contributes to his/her community’s common good. Despite its belief in self-determination and the idea of common good, communitarianism does not support the theory of governance that holds that society is capable of developing self-managing and self-organizing mechanisms in abstraction from government. Such mechanisms cannot be generally assumed to be cooperative because they can often pursue different and conflicting conceptions of the good (Peters and Pierre 2006). Rather, as Kymlicka (1990, 207) points out, a communitarian state exists to discourage


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individual conceptions of the good that conflict with the community’s way of life. Marxian Principles Marxism implicitly advances an argument about justice2 that rejects private property or resources on the grounds of exploitation. The main principle of just distribution can be found in Marx’s Critique of the Gotha Programme, e.g. ‘… from each according to his ability, to each according to his needs …’ (Marx 2005, 615). Elster (1985) calls this principle the ‘needs principle of distribution’. Marx’s principle of justice requires abolition of private property and equalization of productive resources in order to re-arrange the social division of labour in such a way that it no longer causes exploitation. Equalization of productive resources ‘… should take the form of socialising the means of production so that each person has equal participation in collective decisions about development assets, made at the level of either individual firms or national economic planning’ (Kymlicka 1990, 170). Marx clearly thought that only in this way can the principle and practice of ‘equal right’ avoid being at ‘loggerheads’. The question is what is the relationship between the Marxian ideal of social justice and governance? It might be said that for Marx and Engels, the governance process that leads to a just society is state-centric. Specifically, although they systematically produced a critique of the state as an instrument in the hands of the ruling class, they also presupposed its apparatus in the political transition stage from capitalism to what they considered to be the final form of a just society e.g. communism. In their theory, the means of production are centralized and owned by the state before the abolition of social classes and the development of a free and just society (Marx and Engels 1967). To summarize what has been said so far, it is clear that, at least at a theoretical level, there is a gap between distributive justice and governance. The latter includes society-centric processes which are unable to promote and enforce the aggregate application of principles of distributive justice. These principles presuppose government and the political state instead. The reason for this is clear: distributive justice is a predominately political value. Thus, principles of distributive justice can only be fully applied by a central political state that, as Nagel (2005, 113) points out, ‘is the primary locus of political legitimacy’.

2 It should be noted that there is still controversy among scholars as to whether Marx condemns capitalism in the light of any principle of justice. See for instance Geras (1989) and Lukes (1987).

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The Challenge of Genomics The inability of governance to promote and enforce the aggregate application of principles of social justice has important implications for the challenge of today’s genomics-based technologies, namely the fair distribution of new opportunities and especially risks among all members of society. To begin with a general definition, as Gottweis (2002, 208) points out, genomics is a field of the new life sciences research that ‘… embraces both the Human Genome Project (the worldwide programme to document the entire DNA sequence of the human genome) and the study of the relationship between genes and cell function in both health and disease (sometimes alsocalled functional genomics)’. The new knowledge provides the basis for understanding of the relationship between genotypes and disease as well as for identifying the genotypes that predispose individuals to a disease. Furthermore, it results in the development of new genomics-based technologies (genetic enhancement, cloning, gene therapy, genetic testing) and treatments that are tailored according to genetic profiles (pharmacogenomics) or are used for diagnosing and monitoring diseases and for locating targets for new molecules. In this respect, according to Gottweis (ibid.) ‘…functional genomics can also be seen as representing the beginning of a “post-genomic” era that moves on from the sequencing of genes to assigning some element of function to each of the genes in an organism’. However, as has been stressed, apart from health opportunities in terms of curing and/or preventing disease, genomics provokes fears about the potential of genetic discrimination, the rise of a new form of eugenics and the possibility of creating greater inequality in society. It might be argued that institutional response to these fears becomes impossible in the context of the current theoretical gap between governance and justice. In order to demonstrate the argument, let us examine each fear separately and in more detail. Genetic Discrimination Recent statistics show that there is an increasing fear among the public that genetic information may potentially be used to deny insurance and employment to those individuals who appear to have genetic conditions and predispositions to diseases (Buchanan et al. 2000). For instance, Gottweis (2002, 215) presents a 1998 survey according to which ‘… 85 per cent of US citizens believe that employers should be prohibited from obtaining information about an individual’s genetic conditions, risks and predispositions’. This is not an unfounded belief. According to another survey, in 1999 ‘… 30 per cent of the large and midsize companies in the USA sought some form of information about their employees and 7 per cent used this information in awarding promotions and hiring’ (ibid.). Although there are also voices of calm, stressing that genetic discrimination in the areas of employment and


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insurance threatens just a few people (Greely 2001), the general concerns remain. Especially in countries with weak welfare states or with no publicsponsored health coverage such as the US, these concerns are strong and require institutional intervention. Can concerns about genetic discrimination be institutionally dealt with in terms of governance? Can the vulnerability of people to exclusion from particular economic and social arrangements, due to their genes, be minimized through heterarchical processes of governance? The answer to both questions is negative. Imagine someone who has been screened for a genetic disorder or predisposition to the development of a disease and his/her information has been governed by heterarchical mechanisms that involve ‘… self-organised steering of multiple agencies, institutions, and systems which are operationally autonomous from one another yet structurally coupled due to their interdependence’ (Jessop 1998, 29). Such governance cannot prevent someone from becoming a victim of genetic discrimination unless all the multiple agencies and institutions involved agree that it is unjust ‘… to exclude individuals from employment or from health, life or disability insurance if they are known to have genetic diseases or factors that predispose them to diseases’ (Buchanan et al. 2000, 61). This agreement is impossible because it presupposes that all governing non-political actors follow the same principles of justice. Given that governance involves actors that have different and often conflicting conceptions of the good, it is impossible to develop an institutional response to genetic discrimination founded upon an aggregate and consistent political conception of justice.3 For example, actors such as private insurance companies would never cease to discriminate against individuals with genetic disorders or predisposition to diseases because, as Mittra (2007b, 354) points out, ‘… discrimination appears to characterise the very business of private insurance business and distinguishes it most from social insurance systems based on communal solidarity and access on account of need, as opposed to risk status and ability to pay’. Although Mittra (ibid.) thinks that the effects of private insurance discrimination should not be exaggerated, it might be suggested that the shift from government to governance and the gradual elimination of traditional welfare state policies can indeed result in the emergence of a ‘genetic underclass’. It is certainly not an accident that: So far the concerns of patients and consumer groups about applications and practices of genomics [such as] information gathering have been insufficiently addressed by policy makers in the USA and Europe. Today 3 For instance, insurers are likely to maintain that it is just to ‘… have access to all the relevant risk information known by the applicant, so that they can charge an appropriate premium and protect themselves against adverse selection’ (Mittra 2006, 33). By contrast, applicants with specific conditions are likely to believe their ‘eligibility and access to insurance has been compromised by their risk status’ (ibid.).

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The Limits to Governance virtually everybody involved in the science, business and politics of genomics readily agrees that genomics raises many ethical, moral and social issues …. However, these insights and critical evaluations have not yet been followed adequately by corresponding regulatory measures or institutional design. (Gottweis 2002, 216)

It is the argument of this chapter that such regulatory measures and policy designs presuppose non-fragmented and political processes that clearly follow particular principles of justice and defend them against other competing principles of justice. A New Form of Eugenics Concerns about genetic discrimination due to genomics echo the fears raised by the eugenics movements of 1870–1950. As Buchanan et al. (2000, 28) stress: These large scale social movements, originating in England but ultimately involving public advocates and membership organisations from Brazil to Russia, located the source of social problems in the genes of individuals and sought to alter the pattern by which these genes would be transmitted to future generations.

Eugenicists had different approaches to human betterment. Some supported ‘positive eugenics’, encouraging the talented to have more children while some others believed in ‘negative eugenics’, curbing the fertility of those considered to be untalented and unfit (ibid., 32). In any case, the Nazis’ endorsement of the eugenics movement and their programmes of sterilization resulted in taking the lives of thousands of people. The Holocaust itself was part of this eugenics campaign. Although after the defeat of the Nazis, eugenicists worldwide were quick to distance themselves from negative eugenics (ibid., 39), today genomics-based technologies such as IVF and PGD raise new fears about the possible rise of a new form of eugenics. According to Diver and Cohen (2001, 1446), ‘In contemporary dress, “new eugenics” conjures up a fear that genetic technologies will be used not so much by governments as by a privileged class of private actors to engineer a superior race of “perfect” people’. At this point some crucial questions arise: do parents practice eugenics when they seek ‘the perfect baby’ by using the aforementioned genomics-technologies? Are genetic enhancements morally right? Answering this sort of question is presupposed of any institutional development that can deal with the fear of a new form of eugenics. It might be said that this fear cannot be eliminated through heterarchical processes of governance. Multiple agencies and institutions, in abstraction from hierarchical government, appear to be fragmented. Therefore, they are unable to come up with an aggregate argument about why eugenics is wrong in terms of justice. The justice argument against eugenics has to be


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formed in a political context and ‘joined up’ policies of the state. We will offer a discussion of this argument in the next section of the chapter. For the present let us briefly deal with the third important concern about genomics. Social Inequality Fears about genetic discrimination and a new form of eugenics raise the issue of genomics-related social inequality. Specifically, unequal access to such new technologies can exacerbate an already unequal society that widens the gap between rich and poor. What does justice demand in terms of steering genomics? Are people entitled to genetic enhancement, treatment and prevention of disease? Does global justice require that genomics-related innovations be shared with those in poor countries that cannot afford to develop technology? Should access to genomics-based technologies be left entirely to the market (local, national, international, global)? Given the inability of the theory of governance to deal with aggregate principles of social justice, the above questions cannot be answered in terms of heterarchy. For instance, the latter is considered by Jessop (2003, 1) to be: … the reflexive self-organisation of independent actors involved in complex relations of reciprocal interdependence, with such self-organisation being based on continuing dialogue and resource-sharing to develop mutually beneficial joint projects and to manage the contradictions and dilemmas inevitably involved in such situations.

Self-organization is not necessarily a political process that enjoys democratic accountability and transparency. Therefore, it cannot be bound by politically developed principles of justice. Under these circumstances, self-organization is difficult to sustain as a continuing dialogue. Instead, it is more likely that the whole process becomes market led and leaves issues of equal access to genomics to social spontaneity and free competition (Hayek 1960). Certainly Jessop recognizes that there are several sources of governance failure, including the contradictory nature of capitalism, the contingent insertion of partnerships and other self-organizing arrangements (Jessop 2003). However, when it comes to the issue of addressing the challenge of today’s genomics-based technologies effectively, governance as such fails to provide a plausible institutional response due to its fundamental divorce from politically developed principles of distributive justice.

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Addressing the Challenge of Genomics in Terms of Justice Heterarchical governance of genomics stops where justice begins to demand that concerns about genetic discrimination, a new form of eugenics and social inequality be dealt with in terms of principles such as those of egalitarian liberalism, libertarianism, utilitarianism, communitarianism and Marxism. Which of these principles are the most effective ones? What are the differences between egalitarian liberalism, libertarianism, utilitarianism, communitarianism and Marxism in addressing genomics-related concerns? Which principles should policy-makers apply in order to steer genomics according to the requirements of justice? In order to answer these questions one needs to provide a more detailed politico-theoretical analysis of how genomics-related concerns might be addressed in terms of competing principles of distributive justice. Addressing Genomics-related Concerns in Terms of Egalitarian Liberal Principles Generally speaking, concerns about genetic discrimination, a new form of eugenics and genomics-related social inequality might not be all addressed in the same way under egalitarian liberalism. There are important differences among theories such as those of Rawls, Scanlon, Barry and Dworkin. To begin with Rawls, his principle of equal liberty and the difference principle do not justify genetic discrimination. In ‘a well ordered society’ (Rawls 1999, 361), free and equal moral persons cannot be excluded from employment, or from health, life or disability insurance if they are known to have genetic diseases or factors that predispose them to diseases. Rawls’s second principle of justice is quite clear here. This principle has two parts: ‘… part (b) … has priority over part (a), so that the conditions of fair equality of opportunity are also guaranteed for everyone’. This argument is founded upon Rawls’s Kantianism that, on the one hand, rejects natural inequalities as ‘morally arbitrary’ and on the other disapproves of the use of genetic information of free and equal moral persons for the purpose of maximizing utility. Certainly, other egalitarians also share Rawls’s Kantianism. For instance, Barry sharply distinguishes his Scanlonian theory of justice from utilitarianism, rejecting the latter’s tendency towards ‘… a single calculus to cover all cases’ (Barry 1995, 82). For him, it is the principles of justice themselves that matter and not their outcome. This implies that, in Barry’s theory of justice, genetic discrimination is immediately rejected at normative level as an unfair rule without, as he says, ‘… any need to predict what the outcome of it will be at any particular time and place’ (ibid., 83). Also, Dworkin distinguishes between ‘derivative’ and ‘detached’ values. Although the former derive from the interests of particular people, the latter are intrinsic to objects or events.


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On balance, Dworkin (2000) believes that, for instance, ‘… families should be allowed blanket testing of infants, but that the practice underscores the need for effective limits on the dissemination of genetic information’. Undoubtedly, more than any other egalitarian, Rawls specifies equal opportunity in such a way that requires not only the elimination of legal and informal barriers of genetic discrimination but also efforts to eliminate the effects of brute luck in natural lottery. In other words, he seems to recognize the importance of the brute luck view of equal opportunity introduced by Scanlon (1989) according to which there are matters of brute luck which are not within one’s control at all. The fact that someone is born with a genetic disease or with factors that predispose him/her to diseases should not, in itself, lead to a person having lower life prospects than other persons of different genetic conditions. However, elimination of the effects of brute luck in natural lottery does not necessarily mean equal distribution of natural primary goods (NPG) such as health and rigour, intelligence and imagination. As Farrelly (2002, 78) correctly points out: Rawls’s general conception of justice stipulates that only the SPG [social primary goods such as rights and liberties, powers and opportunities, income and wealth, and self-respect] are to be equally distributed, unless unequal distribution of any, or all, of these values is to everyone’s advantage. But what about the NPG? Why does Rawls not include the distribution of them in principles of justice?

Farrelly (ibid.) again correctly observes that for Rawls, although the possession of NPG is influenced by the basic structure of society, they are not under its control. What is subject to human control and what not is, of course, a crucial question. Answering this question has implications for the distinction between the natural and the social. According to Buchanan et al. (2000, 83) ‘Nature, or natural, is often thought to be not only that which is given but also that which must be accepted as beyond human control. In that sense, to say that something is due to nature is to relegate it to the realm of fortune or misfortune, rather than justice or injustice’. Rawls probably never thought that the boundaries between the two realms would be so much blurred by innovation in life sciences and advances of genomics-based technologies. This implies that his egalitarian theory of justice is inadequate and thus unable to deal with the new challenge of genomics. Indeed, as Farrelly (2002, 78) says, ‘This point is of utmost importance when considering how advances in genetic research will revolutionise debates concerning social justice. For these technologies will make it possible for the distribution of NPG to be directly (though not totally) under our control’. In other words, genomics will make it possible for the brute luck view to enlarge the domain of equal opportunity to include

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natural inequalities. These will breakdown the distinctions between persons and goods, subjects and objects of distribution (Buchanan et al. 2000). It is true, of course, that although Rawls seems to recognize the brute luck view, he never shifts away from his main priority that is to address social inequalities under the heading of equality of opportunity (ibid.). It might be argued that his prioritization of social over natural inequalities is important because it implicitly recognizes what current research in genomics explicitly recognizes: genes of individuals are influenced by social conditions. This recognition has crucial implications for addressing concerns about a new form of eugenics and genomics-related social inequalities. Specifically, as far as Rawls’s theory of justice is concerned, it promotes human betterment by means of equalization of SPG. Although this theory recognizes that natural inequalities such as those based on disease genes have impact on social inequalities, it does not justify selection or replacement of genes. Therefore, recent arguments for eugenics selection of embryos (by using IVF and PGD) developed by bioethicists such as Savulescu (2001) cannot be sustained in terms of Rawls’s principles of justice. These arguments are rather based on a different principle that Savulescu calls ‘procreative beneficence’. According to the ‘procreative beneficence’ principle, ‘… couples (or single reproducers) should select the child, of the possible children they could have, who is expected to have the best life, or at least as good a life as the others, based on the relevant available information’ (ibid., 145). This principle requires couples to use genetic tests for non-disease traits that will have a positive impact on the child’s well-being. It might be argued that the ‘procreative beneficence’ principle, first of all, promotes a particular conception of human perfection, violating the principle of value pluralism in a liberal society. Secondly, and more importantly, this principle creates injustice in the distribution of opportunities and risks. For instance, who would benefit from the particular conception of human perfection that the ‘procreative beneficence’ principle promotes? With respect to this question, De Melo-Martin (2004, 81) discusses an interesting hypothetical case. Suppose, he says: … that access to technologies that help us select our children depends on the ability to pay. And suppose also that in this society women are discriminated against. Following the principle of procreative beneficence those with access to the necessary technologies will select for boys, thus increasing their chances at a better life. Those who do not have access to the technology will have to rely on chance. It is quite likely that these boys would be better off, at the same time that their parents’ choices have contributed to the discrimination against women.

Justice is the fifth and most important thesis against eugenics that Buchanan et al. (2000) advance. According to them, the internal logic of eugenics is


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inequality and exclusion ‘… even if we make an effort to accept, for the sake of argument, the eugenicists’ warnings about degeneration and their promise of a better society to come’. Of course, not all egalitarian theories of justice are properly equipped with arguments that can effectively confront eugenics. For instance, Dworkin’s theory of equality of resources does not seem to provide a satisfactory answer to the question of whether parents practice eugenics when they seek ‘the perfect baby’ by using genomics-based technologies. Rather, his arguments tend to defend an equal auction of genes, provided that genomicsbased technologies make it possible for such an auction to take place. Choosing genetic profiles through an equal auction may temporarily pass the Dworkian envy test, but may also create a new eugenicist society of individuals who (they or their parents) were fortunate enough and/or had the knowledge required to select genes favourable to their well-being. Whether combined with insurance or other compensatory schemes, it is certain that this process will have negative impact on the structure of society, increasing social inequalities. It might be argued that egalitarian liberalism fails to deal with such inequalities effectively. For instance, Rawls’s difference principle justifies unequal access to genomics-based technologies, treatment and prevention of disease if this is to the greatest benefit of the least advantaged members of society. Can unequal access to IVF and PGD ever be in the greatest benefit to the least advantaged members of society? The answer is negative. Rawls’s difference principle only allows a small number of people, the wealthy and rich, to test for disease genes, receiving appropriate treatment. Even if we assume that IVF and PGD would be eventually made available to the least advantaged, after a few years time, their position would have been exacerbated in comparison to the advantaged. Addressing Genomics-related Concerns in Terms of Libertarian Principles Libertarians consider themselves to be in the opposite site of egalitarian liberalism. Therefore, the former can only address concerns about genetic discrimination, a new form of eugenics and social inequality from the standpoint of inviolable individual rights. To begin with Nozick, he insists that each person is morally entitled to his/ her own body and powers. From this it follows that each person also has the moral right over the possession of his/her own genetic information. No one is morally justified to interfere with the self-ownership of each person without his/her consent. The principle of self-ownership, at first glance, appears not to justify genetic discrimination. No one, including employers and insurance companies, is entitled to medical records and genetic profiles of persons without their consent. Therefore, theorists such as Moore (2000) think of self-ownership and a libertarian model of private property founded upon Locke’s theory (1988) as being the only answers to the question of privacy and the ‘… right to maintain a

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certain level of control over the inner spheres of personal information’ (Moore 2000, 104). However, there are no easy answers in political theory. Moore and ‘Nozick-style libertarians’ fail to see that their prioritization of self-ownership does not morally prevent employers and/or insurance companies in the market from forcing economically weak or propertyless individuals to reveal their private genetic information in return for employment and/or promotion and/or insurance. In fact, this is a problem of prioritization of self-ownership over freedom that has been exposed a great deal by Cohen. Throughout his Self-ownership, Freedom and Equality, he persuasively argues that ‘… Nozick’s real view is that the scope and nature of the freedom that we should enjoy is a function of our self-ownership’ (Cohen 1995, 67). Indeed, the principle of self-ownership justifies persons who are entitled to their genetic information to transfer them to someone else via the market, no matter the exploitation that takes place in the capitalist process of exchange. This principle reacts against any state of welfare that protects employment and provides insurance to economically weak and propertyless persons. The main concern of Moore and ‘Nozick-style libertarians’ is violation of self-ownership for the sake of social welfare or utility. According to them, if we are serious about privacy rights, we should impose prohibitions against disclosing genetic information. These prohibitions should be independent of any anticipated gains in social welfare or utility. In particular, Moore (2000) uses his argument of self-ownership and privacy rights as a justification for the lifting of bans on genetic therapy. According to him, ‘Top-down laws that seek to regulate genetic therapy will almost always interfere with individual liberty and privacy’ (Moore 2000, 111). This argument excludes social welfare or utility from any strategy of justification of genetic therapy (Farrelly 2002) while, at the same time, it opens the door to a new form of eugenics based on the right of each self-owner to purchase his/her genetic profile in the market. Indeed, self-ownership can justify each individual or group of individuals to develop their conception of human betterment and promote it through positive eugenics. The latter does not directly interfere with each individual’s rights to own his/her body and in this sense it does not directly violate selfownership. For instance, parents who voluntarily decide to join a group of individuals who have a particular conception of human betterment and value blue eyes might be encouraged to seek ‘the perfect baby’ in accordance with this conception and so to purchase a genetic profile that includes the trait of blue eyes without exercise of external force. However, to echo Habermas’s (2003) recent moral reservations, eugenic programmes based on self-ownership can only be compatible with libertarianism if the encouraged genetic interventions do not limit the opportunities of individuals to lead autonomous and meaningful lives (Nozick 1974, 312). This does not seem to be always possible. As Habermas (2003, 96) stresses ‘… eugenic practices … carry the risk of harming the sense of individual autonomy as well as the moral status of persons so treated’.


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In any case, attempts to justify eugenics on the grounds of self-ownership imply that libertarianism is open to both natural and social inequalities. For instance, if one adapted Nozick’s entitlement theory of justice in a eugenics context, one could put forward the following principles: • a genetically enhanced person who acquires a holding in accordance with the principle of justice in acquisition is entitled to that holding. • a genetically enhanced person who acquires a holding in accordance with the principle of justice in transfer, from someone else entitled to the holding is entitled to the holding; • no one is entitled to a holding except by (repeated) applications of 1 and 2. The adapted principle of original acquisition is concerned with the appropriation of unheld things, while the adapted principle of transfer is concerned with the process through which justly held things can be transferred to other persons. In a eugenics context though, both principles assume that genetically enhanced persons are self-owners in the realm of the free market. The third adapted principle is that of rectification and uses historical information about previous injustices. It might be argued that the first adapted principle of entitlement theory excludes non-genetically enhanced persons from the acquisition of external resources and divides society into social groups of genetically enhanced property owners and non-genetically enhanced propertyless persons. The former are not only distinguished from the latter in terms of intelligence, talent, etc., but also in terms of wealth, social power, prestige, etc. In this sense, eugenicsrelated inequality is transformed into social inequality and exclusion. The second adapted principle of entitlement theory reproduces social inequality and exclusion via the market, widening the gap between genetically enhanced property owners and non-genetically enhanced, propertyless persons. Addressing Genomics-related Concerns in Terms of Utilitarian Principles Utilitarianism is a tradition of thought that competes with both egalitarian liberalism and libertarianism in answering the question of fair distribution of genomics-related risks. Specifically, utilitarians address concerns about genetic discrimination, a new form of genomics and social inequality from the standpoint of maximization of aggregate utility or well-being. This implies that they make judgements on the grounds of consequences and welfare. Therefore, for utilitarians, genetic discrimination is neither intrinsically immoral nor always unjust. Employers, insurance companies and even the state are justified, under certain circumstances, in obtaining information about an individual’s genetic conditions. They are also justified, on the grounds of this information, to exclude him/her from particular economic and social

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arrangements, provided that this results in maximization of general utility or aggregate well-being. Thus, for instance, a company or an organization is justified in excluding an individual from the position of chief executive officer (CEO) if he/she was screened and was found to have a predisposition to the development of a disease that might compromise his/her performance and consequently minimize aggregate utility of the company or the organization. Certainly, utilitarianism epistemologically fails to provide ‘objective’ measures of aggregate utility while, at the same time, totally neglects rights and freedoms. This has huge impact on addressing genomics-related concerns about a new form of eugenics and social inequalities. Specifically, utilitarianism can justify the suppression of reproductive freedoms for the sake of development of a eugenics society that maximizes aggregate utility and/or happiness. Given the epistemological problem of measuring the sum total of utility and/or happiness, utilitarian social groups or indeed the state might advance a particular programme of human betterment and impose on individuals the eugenic selection of embryos through the use of IVF and PGD. In this case what is in play is a principle very much similar to Savulescu’s principle of ‘procreative beneficence’ that requires couples to select the child who is expected to have particular traits (intelligence, talent and so on) that will maximize his/her well-being, eventually contributing to maximization of aggregate utility. Utilitarianism is indifferent towards inequalities in the distribution of utility or social welfare. What matters is the sum total. Therefore, utilitarianism is deeply unfair to couples who are either economically or emotionally incapable of selecting the child who is expected to have the best life. In this sense, utilitarianism also fails to prevent the transformation of eugenicsrelated inequality into social inequality and exclusion. Utilitarianism justifies interventions only if social inequality and exclusion result in minimizing aggregate utility. Addressing Genomics-related Concerns in Terms of Communitarian Principles Communitarianism, as Walzer (2004) admits, constitutes a corrected version of liberalism. According to him, ‘This corrected version is politically more engaged, sociologically more informed, and psychologically more open …’ (ibid., xii). Communitarians address genomics-related concerns from the standpoint of self-determination of individuals. Therefore, they do not seem to justify employers or insurance companies in obtaining genetic information about a self-determinant individual and, on the grounds of this information, exclude him/her from certain arrangements if this does not contribute to the particular community’s way of life. To put it another way, for communitarians, justification of genetic discrimination depends on the community’s conception of the common good. For instance, imagine a community that defines the common good as health. In the context of this community, someone (an


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involuntary member) who was screened and was found to have a genetic predisposition to the development of a disease might be treated for his/her disease genes on the grounds of communitarian solidarity. However, someone else, with the same problem, who would wish to enter the community as a voluntary member, might be refused the membership. For communitarians, the distinction between those who are born as involuntary members of a community and those who would wish to join a community as voluntary members seems to be important. The former are more likely to enjoy the trust and solidarity of a community while the latter are more likely to face genetic discrimination. This is particularly important for eugenics. Consider, for instance, a eugenics community that defines its way of life in terms of traits such as intelligence and beauty. Those individuals who would wish to become members of that community would need to enhance themselves by using genomics-based technologies. If they failed to do so, the eugenics community would exclude them. It might be argued that communitarianism can justify violations to reproductive freedoms for the sake of a eugenics conception of common good. For instance, communitarianism can justify quarantine or involuntary vaccination on some individuals. What communitarianism cannot justify is general social inequality within the community. For communitarian thinkers such as Walzer (1983), dominant social goods should be redistributed so that they can be equally or at least more widely shared by all members of the community. No one is justified in monopolizing a dominant social good. Although communitarian thinkers have never explicitly focused on the relationship between dominant social goods such as wealth and natural goods such as intelligence, this relationship can be implicitly established. After all, communitarians such as Walzer (ibid.) leave open the question of whether there are any other kinds of goods such as natural goods. In this sense, they implicitly recognize that, in case there are dominant natural goods, they should be redistributed so that they could be equally shared by all members of the community. Communitarians, especially Walzer, propose a complex equality condition in which social and possibly natural goods have their own spheres of operation. Particular goods have particular social meanings and distributive justice depends on the interpretation of those meanings. According to Walzer (ibid., 19) ‘… complex equality means that no citizen’s standing in one sphere … can be undercut by his standing in some other sphere …’. Thus, to paraphrase Walzer, citizen X may be chosen over citizen Y for an academic position that requires a high level of intelligence and then the two of them will be unequal in the sphere of intelligence. But they will not be unequal generally so long as X’s position gives him/her no advantage over Y in any other (social) sphere such as access to better housing, superior medical care and so on. The question is whether complex equality of social and natural goods can be maintained not only within but also between communities. The answer

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seems to be rather negative. Different communities are likely to value different social and natural goods and therefore it is difficult to reduce dominance or to constrain monopoly of social and natural goods by one community over another. It seems to be one thing to apply an open-ended distribution principle (no good X should be distributed to those who possess some other good Y merely because they possess Y and without regard to the meaning of X) to men and women within communities, and quite another thing to do so to communities within the nation state or indeed to global communities. Addressing Genomics-related Concerns in Terms of Marxian Principles Marxism is a social and political tradition that might be considered to address genomics-related concerns from the standpoint of the ‘needs principle of distribution’. This principle does not justify the situation in which economically weak or propertyless individuals are forced to sell information about their genetic conditions in exchange for employment and insurance. Capitalism appears to alienate individuals from their genetic profiles. The latter are objectified in the market, becoming private property of other individuals. Genetic profiles can be seen here as ‘meta-labour’, that is information about genes that can affect labour power. It might be said that in contemporary capitalism, the private ownership of genomics-based technologies has enabled capitalists not only to appropriate cheap labour but also to appropriate ‘metalabour’. In this sense, following a Marxian line of argument, one could pursue the point that capitalism is an economic and social system of double injustice. That is to say, exploitation does not only take place at the level of exchange of surplus labour but also at the level of exchange of ‘meta-labour’. The latter is presupposed of any future estimation of the former. Therefore, an individual who is excluded from a particular position in the social division of labour after the private appropriation of his/her genetic profile he/she is excluded because he/she is estimated to exchange less surplus labour in the future, due to his/ her disease genes. For advocates of genetic discrimination in employment such as Diver and Cohen (2001), this is something positive, leading to significant efficiency gains on capitalist markets. According to them ‘Armed with genetic test results and corresponding epidemiological data on the correlation between genotype and phenotype, employers may be able to improve the quality of the predictions they can make about the determinants of job performance: intensity and quality of effort’ (ibid., 1461). Certainly, Diver and Cohen abstract from the issue of double injustice within capitalism, concentrating on minimizing transaction costs for the sake of employers. Therefore, they also ignore what Barry (2005, 169) calls pathologies of inequality e.g. negative effects of inequality on all people’s well-being. For Marxists, double injustice within capitalism can only be eliminated through the abolishment of private property relations and the social division of labour. This implies that the ‘needs principle of distribution’ can only be


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fully implemented in an advanced society that Marx defined as communist society. According to him: In a higher phase of communist society, after the enslaving subordination of the individual to the division of labour, and therewith also the antithesis between mental and physical labour has vanished; after labour has become not only a means of life but life’s prime want; after the productive forces have also increased with the all-round development of the individual, and all the springs of co-operative wealth flow more abundantly – only then can the narrow horizon of bourgeois right be crossed in its entirety and society inscribe on its banners: from each according to his ability to each according to his needs. (Marx 2005, 615)

In Marx’s theory, the ‘needs principle of distribution’ theoretically allows distribution of social goods from each according to his/her ability to each according to his/her needs but does not allow distribution of natural goods, including genes of intelligence and talent. Marx accepts the natural inequality of individuals and the plurality of human nature. In this sense, his ‘needs principle of distribution’ may justify genetic interventions for the sake of preventing or curing diseases but not for the sake of eugenic enhancements of humans. The latter are mainly guided by motives of competition and profit. In capitalism, these motives may indeed extend genomics-based technologies beyond the prevention or treatment of diseases into the realm of eugenic enhancements. It might be said that for Marx human betterment is an entirely social matter and can only come about through the elimination of capitalist social relations. Therefore, his ‘needs principle of distribution’ justifies social equality. Substantive right to social equality requires the recognition of natural inequality of individuals. Thus, as Marx (ibid.) stresses: This equal right is an unequal right for unequal labour. It recognises no class differences, because everyone is only a worker like everyone else; but it tacitly recognises unequal individual endowment and thus productive capacity as natural privileges. It is therefore a right of inequality, in its content, like every right. Right by its very nature can consist only in the application of an equal standard; but unequal individuals … are measurable only by an unequal standard in so far as they are brought under an equal point of view … for instance, in the present case, are regarded only as workers … Further, one worker is married, another not; one has more children than another and so on and so forth. To avoid all these defects, right instead of being equal would have to be unequal.

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Marx’s conception of social equality accepts that there should be natural differences among individuals. In this sense, it promotes value pluralism within an ideal society emancipated from exploitative social relations. The Role of Government and the Political State in Just Steering of Genomics From what has been argued in the last section, it becomes clear that neither egalitarian liberalism and libertarianism nor utilitarianism and communitarianism provide sets of principles that might effectively address all three genomics-related concerns in terms of justice. Marxism probably has more to offer in that respect because it provides a concrete principle of social distribution that neither allows genetic discrimination and a new form of eugenics nor social inequality. However, this principle is not without problems. To distribute to each according to his/her needs presupposes a certain level of abundance. The latter does not seem to be feasible. Therefore, the ‘needs principle of distribution’ might only be partly applied. Whatever principles of justice society may choose to apply in steering genomics-based technologies, the role of government and the state is central. The reason for this is well explained by Pierre and Peters (2000) who argue that both government and the state remain the appropriate institutional levels for dealing with aggregate requirements of justice and developing ‘joined-up’ (re)distributive policies, given their political authority and legitimized capacity to impose costs on society through taxes and regulations. Indeed, despite the fact that economic globalization and the emergence of multi-level governance networks have transformed government and the state (Soresen 2006), the latter are institutions deeply embedded in social structures, providing the main focus of politics. Steering genomics-based technologies in terms of justice is a political activity. This means that, before a collective decision is taken at the level of government and the state, there are conflicts and differences about what principles of justice to choose, what resources to collect for developing and implementing policies of just steering of genomics, and how those resources should be spent. Although it is true that, in a number of areas, ‘… modern politics takes place through the medium of governance’ (Stoker 2006, 67), it is also true that in the area of genomics, modern politics fails to respond to the challenge of fair distribution of opportunities and risks through a complex web of existing institutions and dispersed range of heterarchical networks. As Gottweis (2002, 217) points out, ‘The existing institutions either fail to deal adequately with the new regulatory issues raised by genomics, or they still need to be created to face up to the new policy issues’. Only government and the state can close the gap between policy challenges and institutional responses through the medium of policies integrated or ‘joined-up’ under the framework of principles of justice that society chooses to apply in the steering


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of genomics. For instance, if society chooses to apply the ‘needs principle of distribution’, then all genomics-related policies should be integrated or ‘joinedup’ under the framework of this principle in order to achieve (or come close to achieving) distribution of social goods from each according to his/her ability to each according to his/her needs. There is a need for the integrated or ‘joinedup’ policy approach to remove contradictions, confusions, inconsistencies and inefficiencies caused when policies or regulations emerging from different institutions or different levels of governance (regional, national, international, global) contradict one another or ‘provide incompatible signals to policy targets’ (Lyall and Tait 2005, 7). Integrated or ‘joined-up’ policies of government and the political state are mediated by the democratic engagement of citizens. According to Stoker (2006, 89) ‘everyday activism can involve signing petitions, boycotting certain products, or even going on a march …’. Stoker provides evidence that suggests that during the last 20 years or so ‘… more collectivist forms of participation have declined and that more individualist forms have come to the fore’ (ibid., 92). It might be argued that governance is partly responsible for this decline. Complex webs of institutions and chaotic heterarchical networks make it very difficult for activist groups to identify who should be held to account for genomics-related injustices such as genetic discrimination, a new form of eugenics and social inequality. Therefore, democratic engagement with these issues becomes more individualist and less collectivist. As Stoker (ibid.) points out ‘… compared to the mid-1980s, signing a petition or contacting a politician has declined while contacting the media has increased, as has the boycotting of products to express political views’. The decline of collectivist forms of participation reduces the chances of political activists and social movements to substantially influence government decisions toward just steering genomicsbased technologies. Democratic engagement of citizens is important for the political legitimacy of integrated or ‘joined-up’ policies of government and the state. However, the challenge of genomics is not only national but also international and global. Genomics-based technologies are already seen as crucial for global healthcare, ‘… with the potential to spawn innovation in the diagnosis, treatment and prevention of some of the major diseases affecting the developing world’ (Langlois 2006, 54). Therefore, these technologies are also viewed as crucial for reducing or eliminating poverty. As Benatar (2002) correctly observes, poverty is a direct factor of the global diseases load. Indeed, ‘The poor and marginalised within a country often have shorter life expectancies, higher mortality rates, and more illness than average’ (Dwyer 2005, 462). The question is how concerns about fair distribution of benefits and risks of genomics can be addressed at global level. To answer this question one needs to draw on the growing literature of global justice. In a recent article, O’Neill (2002, 35) criticizes contemporary political philosophy because, in her view, it ‘… has been preoccupied … with the requirements for justice within states or societies,

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and (until very recently) has hardly discussed justice across borders’. This is one important reason why questions about just steering of genomics are mainly viewed as internal to states while health problems of poor countries of the world are seen as matters of developing programmes rather than as part of political theories of justice (ibid.). O’Neill suggests that we look beyond the boundaries of state, endorsing the Kantian principle of autonomy that demands actions be based on maxims that can be universalized. In her view, this does not imply that we should adopt a wholly abstract or moral cosmopolitanism but rather more practical and more philosophically rigorous cosmopolitanism based on basic obligations instead of goods or rights. It might be argued that O’Neill’s practical cosmopolitanism faces a number of problems. First of all, as Nussbaum (2006) would point out, it excludes people with physical and mental impairments as well as animals. Secondly, O’Neill’s cosmopolitanism is based on basic obligations which can be probably known by moral reasoning but they cannot ‘fall on all agents and all institutions’ (O’Neill 2002, 44) unless they are transformed into political obligations. This is so even in the case that moral reasoning is motivated by strong causal responsibility for the suffering of others (Dobson 2006, 172). Transformation of basic cosmopolitan obligations presupposes the sovereign state or the political development of an international authority of global sovereignty. As Nagel (2005, 121) correctly points out ‘… the requirements of justice themselves do not, on this view, apply to the world as a whole, unless and until, as a result of historical developments … the world comes to be governed by a unified sovereign power’. From this it follows that enforcement of obligations of global justice could only be politically legitimized in terms of a unified sovereign power. As Nagel (ibid., 138) again observes: Current international rules and institutions may be the thin end of a wedge that will eventually expand to seriously dislodge the dominant sovereignty of separate nation-states, both morally and politically, but for the moment they lack something that according to the political conception is crucial for the application and implementation of standards of justice: they are not collectively enacted and coercively imposed in the name of all individuals that carries with it a responsibility to treat all those individuals in some sense equally.

Indeed, there may be a number of agents of justice. Especially in the case of genomics, there may be agents such as the United Nations Educational, Scientific and Cultural Organization (UNESCO) and initiatives such as the Global Genomics Initiative (GGI) (Langlois 2006) and various nongovernmental organizations (NGOs) which address genomics-related concerns in terms of justice at global level. However, all these agents of justice lack political legitimacy. It is not an accident, for instance, that ‘Governments of developing countries are increasingly complaining about NGOs from the


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west. They accuse western NGOs of hidden agendas that differ from those of most of the people they pretend to be speaking for’ (Logister 2007, 168), a theme taken up by Harsh (this volume, Chapter 9). Due to lack of political legitimacy, international NGOs fail to oblige individuals to act either in terms of moral principles (Pogge 2001) or in terms of empathy (Nussbaum 2006). International NGOs and other institutions mainly act in the name of agencies and states that they have created them. Thus, as Nagel (2005, 138) says ‘… the responsibility of those institutions toward individuals is filtered through the states that represent and bear primary responsibility for those individuals’. If what has been argued in this section is correct, then the question that remains is whether a cosmopolitan approach to just steering of genomics at the global level is impossible. In response to this question, one might follow Hobbes (1991) and Nagel (2005) in maintaining that no matter what principles or standards of justice we choose to steer genomics-based technologies, these can only have full practical application within the boundaries of a unified sovereign power that has the politically and legally legitimate right to impose decisions by force. This does not imply that the cosmopolitan approach is impossible but that it is an ideal approach that, for the moment, cannot be practically implemented, given the weak power of current international rules and supranational institutions. As Nagel (ibid., 146) says ‘We are unlikely to see the spread of global justice in the long run unless we first create strong supranational institutions that do not aim at justice but that pursue common interests and reflect the inequalities of bargaining power among existing state’. Conclusion This chapter has examined the relationship between governance and justice, focusing on the challenge of genomics. The argument has been that this challenge, namely fair distribution of opportunities and risks, creates limits to governance. Specifically, it has been first pointed out that heterarchical processes of governance are unable to promote and enforce the aggregate application of principles of justice such as those of egalitarian liberalism, libertarianism, utilitarianism, communitarianism and Marxism. Secondly, it has been shown that this inability has implications for the challenge of genomics because genomics-related concerns such as genetic discrimination, a new form of eugenics and social inequality cannot be institutionally dealt with in terms of heterarchical governance. The latter stops where justice begins to demand these concerns be addressed in terms of aggregate principles of justice. Thirdly, it has been argued that the majority of principles in question fail to successfully address all three genomics-related concerns. The main reason for this is that innovation in the new life sciences and advances of genomics-based technologies have blurred the boundaries between nature and social justice.

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Therefore, it is not clear whether liberal and communitarian justice requires (re)distribution of both social and natural goods. Marxism, on the other hand, only theoretically seems to be a more effective approach than the others to today’s challenge of genomics. Although it advances the ‘needs principle of distribution’ that clearly does not allow emergence of genetic discrimination, a new form of eugenics and social inequality, practically this principle is difficult to be fully applied. Fourthly, it has been maintained that, whatever principles of justice society chooses to apply in steering of genomics, the role of government and the state is central. Only a combination of integrated or ‘joined-up’ policies of a sovereign power and democratic engagement of citizens can overcome the limits that the challenge of genomics creates to governance. This is not only the case at the level of the nation-state but also at the level of global world. Steering of genomics in terms of cosmopolitan justice is an attractive ideal without immediate practical application. References Bache, I. (2003), ‘Governing through Governance: Education Policy Control under New Labour’, Political Studies 51, 300–14. Barry, B. (1995), Justice as Impartiality: A Treatise on Social Justice, Vol. II (Oxford: Clarendon Press). Barry, B. (2005), Why Social Justice Matters (Cambridge: Polity). Benatar, S.R. (2002), ‘Reflections and Recommendations on Research Ethics in Developing Countries’, Social Science and Medicine 54, 1132–8. Bentham, J. (1970), ‘An Introduction to the Principles of Morals and Legislation’, in Burns, J.H. and Hart, H.L. (eds) The Collected Works of Jeremy Bentham (Oxford: Clarendon Press). Buchanan, A., Brock, D.W., Daniels, N. and Wilker, D. (2000), From Chance to Choice: Genetics and Justice (Cambridge: Cambridge University Press). Cohen, G.A. (1995), Self-Ownership, Freedom and Equality (Cambridge: Cambridge University Press). Cohen, G.A. and Graham, K (1990), ‘Self-Ownership, Communism and Equality’, Proceedings of the Aristotelian Society 64, 25–61. Cozzens, S.E. (2007), ‘Distributive Justice in Science and Technology Policy’, Science and Public Policy 34:2, 85–94. De Melo-Martin, I. (2004), ‘On our Obligation to Select the Best Children: A Reply to Savulescu’, Bioethics 18:1, 72–83. Demers, M. (1998), Government and Governance (Ottawa: Canadian Centre for Managing Development). Diver, C.S. and Cohen, J.M. (2001), ‘Genophobia: What is Wrong with Genetic Discrimination?’, University of Pennsylvania Law Review 149:5, 1439–82. Dobson, A. (2006), ‘Thick Cosmopolitanism’, Political Studies 54:1, 165–84.


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Lyall, C. and Tait, J. (2005), ‘Shifting Policy Debates and the Implications for Governance’, in Lyall, C. and Tait, J. (eds) New Modes of Governance (Aldershot: Ashgate). Lyons, D. (1984), ‘Utility and Rights’, in Waldron, J. (ed.), Theories of Rights (Oxford: Oxford University Press). Marks, G. and Hooghe, L. (2004), ‘Contrasting Visions of Multi-level Governance’, in Bache, I. and Flinders, M. (eds) Multi-level Governance (Oxford: Oxford University Press). Marx, K (2005), ‘Critique of the Gotha Programme’, in McLellan, D. (ed.) Karl Marx: Selected Writings (Oxford: Oxford University Press). Marx, K. and Engels, F. (1967), The Communist Manifesto (London: Penguin). Merrien, F.-X. (1998), ‘Governance and Modern Welfare States’, International Social Sciences Journal 155, 57–67. Mill, J. (1937), An Essay on Government (Cambridge: Cambridge University Press). Mittra, J. (2006), ‘Genetic Exceptionalism and Precautionary Politics: Regulation for Uncertainty in Britain’s Genetics and Insurance Policy Process’, Science and Public Policy 33:8, 585–600. Mittra, J. (2007a), ‘Marginalising Eugenic Anxiety Through a Rhetoric of Liberal Choice: A Critique of the House of Commons Select Committee Report on Reproductive Technologies’, New Genetics and Society 26:2, 159–78. Mittra, J. (2007b), ‘Predictive Genetic Information and Access to Life Assurance: The Poverty of Genetic Exceptionalism’, BioSocieties 2, 349–73. Moore, A.D. (2000), ‘Owning Genetic Information and Gene Enhancement Techniques: Why Privacy and Property Rights may Undermine Social Control of Human Genome’, Bioethics 14:2, 98–119. Nagel, T. (2005), ‘The Problem of Global Justice’, Philosophy and Public Affairs 33:2, 113–47. Nozick, R. (1974), Anarchy, State, and Utopia (Oxford: Blackwell). Nussbaum, M.C. (2006), Frontiers of Justice: Disability, Nationality, Species Membership (Cambridge, MA and London: The Belknap Press of Harvard University Press). O’Neill, O. (2002), ‘Public Health or Clinical Ethics: Thinking Beyond Borders’, Ethics and International Affairs 16:2, 35–45. Papaioannou, T. (2008), ‘Nozick Revisited: The Formation of the RightBased Dimension of his Political Theory’, International Political Science Review 29:3, 261–80. Peters, B.G. and Pierre, J. (2006), ‘Governance, Government and the State’, in Hay, C., Lister, M. and Marsh, D. (eds) The State: Theories and Issues (Basingstoke and New York: Palgrave Macmillan). Pierre, J. and Peters, B.G. (2000), Governance, Politics and the State (Houndmills and London: Macmillan Press Ltd).


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Pogge, T.W. (ed.) (2001), Global Justice (Oxford: Blackwell Publishers). Raphael, D.D. (1994), Moral Philosophy (Oxford: Oxford University Press). Rawls, J. (1972), A Theory of Justice (Oxford: Oxford University Press). Rawls, J. (1999), ‘Social Unity and Primary Goods’, in Freeman, S. (ed.) John Rawls: Collected Papers (Cambridge, MA: Harvard University Press). Rhodes, R.A.W. (1994), ‘The Hollowing Out of the State: the Challenging Nature of the Public Sector in Britain’, Political Quarterly 65, 138–51. Rhodes, R.A.W. (1996), ‘The New Governance: Governing without Government’, Political Studies 44, 652–67. Rhodes, R.A.W. (1997), Understanding Governance (Milton Keynes: Open University). Rosenau, J.N. (1995), ‘Governance in the Twenty-first Century’, Global Governance 1, 13–43. Savulescu, J. (2001), ‘Procreative Beneficence: Why We Should Select the Best Children’, Bioethics 15: 5/6, 413–25. Scanlon, T. (1982), ‘Contractualism and Utilitarianism’, in Sen, A. and Williams, B. (eds) Utilitarianism and Beyond (Cambridge: Cambridge University Press). Scanlon, T. (1989), ‘A Good Start: Reply to Roemer’, Boston Review 20:2, 8–9. Soresen, G. (2006), ‘The Transformation of the State’, in Hay, C., Lister, M. and March, D. (eds) The State: Theories and Issues (Basingstoke and New York: Palgrave Macmillan). Stoker, G. (1998), ‘Governance as Theory: Five Propositions’, International Social Sciences Journal 155, 17–28. Stoker, G. (2006), Why Politics Matters: Making Democracy Work (Basingstoke and New York: Palgrave Macmillan). Tait, J. and Lyall, C. (2005), ‘A New Mode of Governance for Science, Technology, Risk and Environment’, in Tait, J. and Lyall, C. (eds) New Modes of Governance (Aldershot: Ashgate). Taylor-Gooby, P. (1999), ‘Hollowing out Versus the New Interventionism: Public Attitudes and Welfare’, in Svallfors, S. and Taylor-Gooby, P. (eds) The End of the Welfare State? Responses to State Retrenchment (London and New York: Routledge). Walzer, M. (1983), Spheres of Justice: A Defence of Pluralism and Equality (Oxford and Cambridge, MA: Blackwell). Walzer, M. (2004), Politics and Passion: Toward a More Egalitarian Liberalism (New Haven, CT and London: Yale University Press). World Bank (1994), Governance: The World Bank’s Experience (Executive Summary, World Bank).


Chapter 3

The Roles of Values and Interests in the Governance of the Life Sciences: Learning Lessons from the ‘Ethics+’ Approach of UK Biobank Graeme Laurie, Ann Bruce and Catherine Lyall

Introduction In this chapter we explore whether the different instruments of governance provide appropriate methods for negotiating between different value-positions and balancing different interests of various stakeholders. We argue that each of the instruments of governance – whether these involve a key role for scientific evidence, stakeholder engagement, ethical oversight or other means – can contribute to varying degrees in these processes but none is perfect in this respect. We contend, however, that a crucial element in improving the relationship between governance models and the stakeholders affected by them is the incorporation of mechanisms that make explicit the value-positions that inform and are supported by decisions or policies, and the articulation of reasons for these decisions or policies as they impact on governance of the life sciences. The objective should not be to attempt to reflect most values nor necessarily to accommodate the majority of interests, but rather to develop models of reflexive governance, that is, models which are democratic and systematic in garnering evidence about the range of values and interests at stake, in exploring where (and why) there are commonalities and differences, and in developing policies or taking decisions which are ultimately acceptable to a body of ‘reasonable’ stakeholders. Above all, these models of governance must be responsive to change as the life sciences, their associated technologies, societal values and stakeholders’ interests evolve through time. This entire volume is concerned with new models of governance, and in this chapter we examine one example of experimental governance that exists in the life sciences today: the case of UK Biobank.1 We characterize this as an 1 We should, at this stage, declare a particular interest, which is that one of us, Graeme Laurie, is currently Chair of the UK Biobank Ethics and Governance Council – a key element of the novel governance framework (as we discuss below). That said,

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‘Ethics+’ approach, by which we mean that its governance regime has been developed over and above existing regulation and governance mechanisms, for reasons that we explore presently, and in ways that have not previously been tried or tested. This example serves as an interesting illustration of how models of governance might be re-visioned into a more reflexive mode in order to meet the current and future challenges of the life sciences. The chapter proceeds as follows. We first outline the governmentgovernance distinction, characterized elsewhere in this book, and give reasons for considering the values-interests dimension as important in this context. We then explore the history, nature and workings of the UK Biobank governance model and set it within a framework which examines how values and interests are likely to come into play in the context of the project. This framework contains some of the key elements of governance, such as the role of scientific evidence, trust, choice, public engagement, and ethical/oversight committees. We analyse throughout how the particular governance arrangements of UK Biobank do or do not reflect our aspirations for reflexive governance. Finally, we consider whether, and how, it may be possible to ‘future-proof’ governance arrangements, both in the context of UK Biobank and beyond. Government and Governance A series of controversies in the UK in the 1990s, including BSE, salmonella in eggs, foot and mouth disease and the prospect of genetically modified (GM) food, undermined public confidence in the ability of science to provide adequate and trustworthy evidence for decisions about trajectories in the life sciences and led to the questioning of the role of scientific evidence in decisionmaking and policy formation. At the same time, the development of new governance structures, for example under the Modernising Government agenda (HM Government 1999), sought to refashion the processes of governing, including a framework for excellence in policy-making and a strong emphasis on inclusivity and learning lessons from policy experience in other countries. This led to a heightened focus on an ‘evidence-based’ approach to policy-making – with a philosophy of ‘what matters is what works’ (Solesbury 2001); and an emphasis on the need for collaboration (to identify what matters) and the role of ‘evidence’ (to discover what works) (Nutley and Webb 2000). The governance perspective therefore emphasizes the coordination of multiple actors and institutions to define and achieve goals in a complex political arena where the hierarchy steers the policy-making process with a lighter touch than may previously have been the case: hence a ‘new mode Laurie writes here in an entirely personal, academic capacity and nothing herein should be taken to reflect the views of the Council.

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of governance’ (Lyall et al. Chapter 1 this volume; Lyall and Tait 2005) has emerged which focuses on participatory approaches and institutionalized coordination between the supra-national, national and regional levels. This is leading to increasingly complex state/society relationships where networks rather than hierarchies dominate the policy-making process and there is a blurring of public/private boundaries (Bache 2003). As discussed in Chapter 1, many of the complicating factors identified in the application of the governance agenda to science and technology-related issues arise from complex interactions between the still-necessary, government-based regulation and control of technology and the main themes of the governance agenda, particularly the contrasting and sometimes incompatible requirements for policy decisions to be evidence-based and at the same time for a greater degree of stakeholder engagement in decision-making. ‘What works’ may not be a question of facts or evidence, so much as an understanding of context and an articulation and clarification of values; this requires a decision-making process that is open and democratic and which can facilitate a process of ‘deliberation and public learning rather than (strategic) control’ (Parsons 2001). This, in turn, raises concerns about transparency and accountability, and has led to calls for – and questions about – the representativeness of those included in deliberations (Newman 2001, 68). It implies an iterative process and not the imposition of an inflexible and unresponsive system of command. The process is made all the more complex by the fact that decisions are more likely to emerge or accrete over a period of time (Nutley and Webb 2000). The context, then, for the need for governance was the perceived necessity for inputs other than scientific evidence in order to ensure that a specific technological development met public and stakeholder expectations and demands to avoid, as far as possible, damaging conflict situations. The challenges of this ‘new governance’ of science and technology lie less in the philosophy of the approach but more in its execution. It is this execution in a practical example that we will examine in this chapter. The example to be used is the ‘Ethics+’ approach to governance that applies to UK Biobank. Before examining our case study in detail, however, it is important to add a further layer of analysis to the approach adopted in this chapter and which complements the contributions found elsewhere in this volume. This is the particular role played by interests and values within the rubric of new governance regimes; that is, we seek to explore how, how well, and how far (different) interests and values are built into the architecture and operation of new models of governance. Our premise is that this is a potentially invaluable approach to examining governance design. We contend that emerging models of governance need to be able to negotiate different value-positions and interests if these regimes are to realize their objectives as effective and efficient means to promote the stakeholder agenda within the life sciences in the twenty-first century.

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Interest-based and Value-based Positioning Potential and actual conflicts around science and technology arise from a complex interaction of ethical and social issues; of concerns about risk and its management; of questions of power and control; of varying valueassumptions and preferences; and of contrasting and diverging interests in a given science or technology project or trajectory. The need to ascertain the root causes of a dispute has long been a basic tenet of mediation in conflict situations (e.g. Burton 1990). Distinguishing between interests and values, and identifying the consequent differences in types of possible resolution to conflicts that invoke interests and values, has also been important in the mediation tradition (Burton 1990). Miscommunication in a dispute may arise when one party considers an issue as an interest and the other considers the same issue to be a non-negotiable value. However, once a fundamental value is articulated and recognized, it may be possible to negotiate means of satisfying this which are acceptable to others who do not share the same value. By contrast, a range of interests may well be readily accommodated, not all of which will be congruent, assuming that these are not in direct conflict with each other. But failure to recognize the different nature of value-based and interest-based arguments may mean that the root of a dispute and the factors that are really important to protagonists are not uncovered. Attempts at resolution may, then, be entirely fruitless because they miss the point about what is actually, and fundamentally, at stake. Tait (2001) gives an example of this in the context of regulation of genetically modified (GM) crops where the risk regulatory regime tasked with regulating GM crops had no mechanism for dealing with objections such as the appropriate level of corporate control over food chains or preferences over the type of food production system (intensive vs organic). Most disputes are, of course, an amalgam of value-based and interest-based arguments raised within a particular context. Nevertheless, understanding these dynamics may be important in leading to improved solutions for resolving disputes around new technologies or other advances in the life sciences. Tait (2001) extensively studied the debates around GM crops and developed a conceptual approach that distinguishes between value-based and interestbased arguments surrounding the technology. She exemplifies the conception of interest-based and value-based conflicts as follows: the former is characterized as ‘Not-in-my-backyard’, the latter as ‘Not-in-anybody’s-backyard’. She suggests that the nature of conflicts varies depending on the extent to which values become involved. Bruce and Tait (2003) observe that values and interests of an individual may be congruent or they may be in opposition. For example, an individual with a degenerative disease who may have an interest in the development of embryonic stem cell therapies may well object to the development of such therapies on the basis of their values. Value-positions pose particular difficulties because they may be hidden and unarticulated for


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strategic purposes, because they are not deemed acceptable, or because they are so deeply entrenched that they appear to require no articulation as the presumption is that they are commonly-shared and acknowledged. The two types of argument have rather different characteristics. Interest-based conflicts tend to be restricted to specific developments, are likely to be organized locally, and can often be resolved with the provision of (i) more information, (ii) compensation or (iii) compromises through negotiation. Value-based conflicts, in contrast, often represent ‘ideological opposition’ which tend to spread across related developments (e.g. any use of human embryos for research purposes), are often organized on a national or international basis, and may be very difficult to resolve because (i) information can be viewed as propaganda, (ii) compensation as bribery, and (iii) negotiation and compromise as betrayal (Bruce and Tait 2003). It is often assumed that the interests in question are largely, or solely, selfregarding interests – if true, then this may be fatal to any accommodation of a plurality of positions in any given technology trajectory. By the same token, if value-based positioning is equated with ideology and the defence of ‘The Cause’ there may equally be no room for accommodation. In such cases promotion of The Interest or The Value becomes the desirable end, nothing more. This leaves but two options: the defeat of one party or the other – the offending industry or the pressure group (to use a clichéd paradigm). But what lessons can be learned from such a clichéd example? In particular, what might we take from these dynamics that tend towards polar opposites to design better governance regimes that do not tend, inevitably, towards irresolvable conflict? We can begin by reconsidering the nature of values and interests themselves. It is possible, for example, for interests to be other-regarding, such as the interests of other persons or other stakeholders, of future generations, or of the (admittedly amorphous) public interest. Values, too, need not be unidimensional nor inevitably determinative of any particular outcome to the exclusion of other options. Secondly, and whether or not partisan positioning has occurred, a proper articulation of the range of values and interests at stake in any given scientific endeavour affords all parties the fullest possible account of factors to be considered. Rather than a means to the end, then, values and interests can serve to inform the governance process and to open up options, both in terms of the possible ends towards which the process could proceed, and in terms of reaching an accommodation of ends, if this is appropriate in the circumstances. By the same token, it should not be thought that this would merely be a crude process to stake out non-negotiables or to identify different tolerances among different stakeholders; it can also serve to explore more deeply what underlies interest and value positions, to offer the holders of those positions an opportunity to engage in and around those positions, and it can generate an environment where there are legitimate expectations that

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those positions will be taken into account. This is what we mean by a reflexive mode of governance. A proper articulation of values and interests is important precisely because of their fundamentality both to those who hold them and to setting a defensible course for policy, decision-making and action. To have one’s position taken into account, however, clearly cannot mean that all positions will hold equal sway, for reasons which are trite and need no repetition here. It can require, however, that any model and process of governance makes explicit the values and interests that are in play in the model that has been established, those which are not, and the reasons why one or more positions have been preferred over others. Clearly, this should be more than a ‘like-it-or-lump-it’ approach to governance, and we explore the contours of this in more detail below. For now, we raise a final point for this section which arises from our discussion of a process of governance: this reflects the fact that it is important to appreciate that values and interests can, and do, change over time. An effective governance regime must be able to anticipate and respond to these (and other) changes – and thereby to avoid future conflict – and it will only be able to do so if mechanisms are in place to engage with stakeholders throughout the life of the scientific endeavour and thereby to identify, map and respond to any shifting dynamics around their values and interests. We use the terminology ‘stakeholders’ here to include everyone who has a stake in the development (whether they are aware of this or not). This includes scientists, policy makers, research funders, and – in the context of our case study: participants in UK Biobank, staff of UK Biobank, UK Biobank management and advisory bodies, people running other biobanks, health-care staff and patients, industry, NGOs, and a wide range of publics. There is therefore unlikely to be a single ‘stakeholder’ view that needs to be taken account of, but rather a range of values and interests that needs to be negotiated. While the terminology of ‘values’ and ‘interests’ oversimplifies particular situations, such a framework for thinking about what is at stake may bring increased appreciation of the position of stakeholders and it can play a key role in uncovering greater sensitivity to potential conflicts and fuller appreciation of how these can be avoided or more effectively resolved should they ever arise. What, then, are the values and interests at stake with biobanks? Values and Interests in Biobanks and the Role of Scientific Evidence We do not intend to enter a discussion of the diverse meanings of the term ‘biobank’ for the purposes of this chapter. We are concerned primarily with exemplars which involve collections of human biological material, together with genotypic and/or phenotypic data from participants, collected on a large-


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scale and often at a population level, and with a view to establishing a research resource that will persist for an indefinite period of time. The experiences of early biobanks of this kind, and public reactions to them, have already provided insight in identifying the kinds of values and interests at stake. The Icelandic Health Sector Database attracted considerable criticism, for example, not only for its plans to link genetic, health and genealogical data of the Icelandic people on the basis of presumed consent (that is, on the premise that citizens would be included in the project and that the ‘choice’ was to opt-out not to opt-in), but also for the decision to grant an exclusive licence to a single company (deCODE genetics) to construct and manage the database (Gertz 2004). On the other hand, the needs of potential users of the resource (scientists and commercial parties) also need attention in order to ensure a successfully-functioning enterprise. A biobank developed in a region of Sweden (Västerbotten County), marketed as an ethical biobank and involving a Swedish biotechnology company (Uman Genomics), folded in part due to disputes over allocation of intellectual property rights and difficulties in matching its ethical oversight model with the intellectual property requirements of an economically-viable venture (e.g. Rose 2003; Hoyer 2004). These examples demonstrate that there are a range of stakeholders with interests both in the success of a biobanking project, but also its set-up and governance mechanisms; key among these groups are participants and potential users/collaborators. More fundamentally, however, there are those who question genetic and genomic databases as valuable projects in their own right; this is not because of concern about how far, or how well, various interests are recognized or protected, but because of concerns about the science itself or the merits of spending finite resources in this field of enquiry as opposed to others. In other words, there are also value-based objections to these endeavours. We suggest, accordingly, that it is helpful to consider more closely the nature of values and interests in biobanks, and the role of scientific evidence in setting the scientific agenda and in decision-making, before examining how these have been addressed within the context of UK Biobank. Values One of the main value dimensions involved in biobanks (Bruce and Tait 2004) is the contribution of genetics research to health care in comparison to other health care measures (e.g. public health measures, environmental measures). For some, the balance appears to be too far in the direction of genetics at the expense of the ‘real’ causes, such as diet, lack of exercise and pollution (e.g. GeneWatch UK 2002). The objection is not necessarily to the existence of biobanks as such, but to the culture of favouring genetic explanations of illness to environmental ones. UK Biobank, for its part, has a strong emphasis on collecting lifestyle, diet and environmental information unlike some biobanks,

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therefore this tension is potentially less relevant to UK Biobank than some other initiatives. Notwithstanding, it must be acknowledged that the very ‘science’ of biobanks can be seen to have become a disputed matter of values, calling into question the role of scientific evidence – which has traditionally been seen as ‘value-neutral’ – in setting agendas and in decision-making. The current approach to agenda-setting and decision-making in scientific areas has particular features: • it presupposes separate value-neutral and value-laden stages in the processes; • it preferences the allegedly value-neutral ‘evidence’ stage and, because of this, is predisposed at further stages towards any value system that follows that evidence (and by implication is less disposed to value systems which question or reject that evidence); • it perpetuates a fallacy that there is any such thing as a value-neutral position (or evidence). But scientific debates in the policy realm increasingly take place in a context of uncertainty, and this is particularly true in the context of biobanks. This is so equally because of uncertainty about the science knowledge-base (because it is at the cutting-edge of knowledge and because it is long-term), and because there is evidence of growing mistrust in the sources of the available information, leading to uncertainty about social attitudes and tolerances, which might shift, unpredictably, at indeterminate points in the future. This can have at least two dramatic consequences. First, parties in dispute may conveniently find ‘evidence’ to support their respective positions, each thereby mustering strength and further entrenching their stance. Second, in the absence of reliable or accurate evidence, parties may fall back unquestioningly on their respective (diametrically opposed) interest or value-positions. The net result in both circumstances is often polarization of debate and policy stalemate. This is not to denigrate the contribution that sound scientific evidence should have in the evidence-based policy process. Science that is evaluated in its own sphere as being of good quality should be an essential component – but only one component. From the above it is clear that scientific evidence will be contested once other principles enter the fray. A failure to appreciate this might steer the discourse in a particular direction and away from a free and full discussion of the range of value-positions that might be in play. The reality is that there is often a wide margin of possibilities in how a particular piece of scientific evidence can be interpreted. Scientific evidence clearly has a key role in providing an evidence-base, but it is one that should allow different options to be elucidated, new futures to be envisaged and new policy options to be developed (Pielke 2007). Furthermore scientific expertise should come from a wide range of relevant disciplines. Expertise of non-scientific actors in the particular policy domain can also


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provide useful evidence of how science and technology interacts with practice. Wider stakeholder (including public) participation may have particular input in defining how issues are framed and in bringing in a wider set of values, as we discuss further below. Interests Some of the interests which underlie the development of genetic databases include (Bruce and Tait 2004): • the scientific drive to use new knowledge to improve health; • the need to ensure that people who participate are protected from harm because of information derived from information and biological material donated to biobanks; • a fair distribution of any benefits materializing from the use of the biobank resource. We categorize these specific features as ‘interests’ because they are inherently negotiable. However, there will be various values that underpin these interests, such as the value of increasing scientific knowledge and the value of preventing exploitation and safeguarding a commitment to basic principles of justice. Overarchingly, there is also the value in promoting the public good through such endeavours, although, as we have indicated above, these particular means to promote such a common value are themselves disputed matters. Nonetheless, if the value of biobanking is accepted, there remains the question of how the public good is to be furthered through the biobank, and here we increasingly find the language of the public interest being used. We have, then, a range of interests arising from biobanks, with a corresponding range of potentially conflicting interest-based positions. The logically-prior question is, however, how are these interests to be recognized, negotiated, respected and protected (or otherwise). We suggest that there has been a net failure to date to address this question to any meaningful extent in the context of biobank governance mechanisms. Indeed, this is symptomatic of failings that we have identified in other areas of the life sciences which nonetheless purport to adopt approaches that are more oriented towards stakeholder interests, public engagement and/or participatory democracy. We propose, rather, to consider how a more explicit commitment to exploring values and interests within governance mechanisms can both begin to answer the above question and potentially also to avoid some of the pitfalls associated with other ‘engagement’ strategies. We now intend to develop this rather abstract discussion by applying it to our case study of UK Biobank. We do so through an examination of UK Biobank’s innovative governance design which deploys a variety of tools and mechanisms to execute good governance and in an attempt to foster trust,

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including the establishment of an Ethics and Governance Framework, the adoption of a multi-faceted model of broad consent, commitments to public engagement in decision-making and project development, and on-going oversight from an independent Ethics and Governance Council. UK Biobank UK Biobank aims to build a major research resource containing lifestyle, physical and genetic information, as well as samples, from 500,000 people in the UK, aged between 40 and 69. The purpose of UK Biobank is to support a diverse range of health-related research intended to improve the prevention, diagnosis, and treatment of illness, as well as to promote health throughout society, both in the United Kingdom and internationally. Neither the objective nor the approach of UK Biobank are novel from an epidemiological perspective. The project design, in scientific terms, has been considered and approved by an international scientific review body; and in ethical terms, it has received approval from a multi-centre research ethics committee. Recruitment began in April 2007, and at the time of writing over 160,000 participants had agreed to take part. The recruitment stage will run until 2010, and it is unlikely that access to the resource will be granted before this stage has been completed. UK Biobank is subject to the same plethora of regulations as any other project in the life sciences that involves the participation of human subjects, including the provisions of the Data Protection Act 1998 (with respect to the processing of personal data from which individuals are identifiable), common law duties of confidentiality (again, with respect to the protection of individual privacy), and more recent regulations concerning the storage and use of human materials (under the Human Tissue Act 2004). When the time comes to grant access to the resource, UK Biobank will likely use standard means to control access and use of data or samples from the resource, including data control contracts, material transfer agreements and intellectual property rights. In all of these respects, then, there is nothing novel about UK Biobank. Indeed, there is much in the way of government regulatory control already in existence, imposing a top-down, legally-binding framework within which UK Biobank has been developed. Our interest in the project for the purposes of this chapter, however, arises from its entirely novel approach to governance, and its potential impact on the life sciences policy arena. The actors involved in this area are not directly policy makers although the expected provision of information arising from the UK Biobank resource is expected to have considerable policy relevance and fits in well with the policy aim of realizing the potential of genetic information as set out by the UK Department of Health:


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Our genes play a fundamental role in determining our health and our response to healthcare. Six out of ten people are likely to develop a disease that is at least partially genetically determined by the age of 60. Greater knowledge of genetics will have a major impact on our understanding of human illnesses and herald a step-change in disease prevention, diagnosis and treatment. (Department of Health 2003, 7)

UK Biobank is not, however, a government initiative (at least not strictly nor directly so). Although the Department of Health is involved, the project’s main funders are the Wellcome Trust (WT) and the Medical Research Council (MRC).2 And, while the MRC is a publicly-funded organization, the Wellcome Trust is an independent charity and the largest source of non-governmental funds for biomedical research in the United Kingdom. It was upon the initiative of these two funders that the idea to explore the need for an additional layer of governance was raised when the entire notion of establishing a UK biobanking resource was first mooted towards the end of the twentieth century. The first initiative in the process of re-visioning governance was the establishment of an Interim Advisory Group by the funders to advise on how the project should be established and taken forward.3 A particular challenge for this group was the expectation that it should conduct its deliberations in-parallel with development of the scientific protocol and in light of the scientific evidence arising therefrom. The group met numerous times during 2003-2004 and was able to draw on public consultations conducted before and during this time about the biobanking initiative and its potential governance structures. The core recommendations of the Group were, first, that UK Biobank should adopt an Ethics and Governance Framework which lays out explicitly the commitments of UK Biobank to its participants, the public and other stakeholders, and, second, that a permanent and independent Ethics and Governance Council should be established to oversee the project and to monitor and advise on its operation. These recommendations were put out to public consultation and ultimately accepted by the funders. The Ethics and Governance Framework is an instrument of UK Biobank and available on its website.4 It is designed as a living document to be revised as necessary over time as the project develops, as new and unforeseen challenges arise, and/or importantly, as social attitudes 2 UK Biobank is funded by the Wellcome Trust, the Medical Research Council, the Northwest Regional Development Agency, the Department of Health, the Scottish Government and the Welsh Assembly Government. 3 The membership of the Interim Advisory Group was: Dr William Lowrance (Chair), Professor Alastair Campbell, Professor Erica Haimes, Dr Graeme Laurie, Professor Chris Mathew, Professor Jean McHale, Mrs Helen Millar, The Baroness O’Neill of Bengarve, and Mrs Madeleine Wang. 4 www.ukbiobank.ac.uk.

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shift (including values and interests). The Ethics and Governance Council began its work in November 2004 and exists as an entity independent of UK Biobank (albeit funded by the Wellcome Trust and MRC).5 We reiterate, however, that these arrangements have been added on top of existing – and what some might consider already-burdensome – layers of control. Why, then, is any other governance measure required? There is no single answer to this question. It is not because of anything unique about the science per se, as we have already suggested, although the sheer scale of the project – to recruit almost 1 per cent of the UK population – has certainly been mooted as a factor requiring special attention to its governance. Second, the long-term nature of the project and the as-yet unknown categories of research which may be conducted with the resource has raised ethical issues about the role of participants’ consent – can this be meaningful when so much about the future is uncertain? Is it acceptable to ask for ‘broad consent to participate in UK Biobank’? This also poses related questions about the on-going security of participants’ samples and data once access is granted, and it further raises the issue of monitoring whether UK Biobank will be managed within its broad purposes and true to the original consent given by participants. Paradoxically, despite the range of regulatory practices and bodies that populate the life sciences arena, and notably the role of research ethics committees, there are no bodies with a responsibility for on-going monitoring and review of such issues. It was therefore perhaps serendipitous and appropriate that the consultation exercises commissioned by the funders found strong support for the establishment of an oversight body to advise on and monitor the management and operation of the project through time. These factors may help to explain why UK Biobank has been set up in the way that it has, but they do not provide any indication – and certainly cannot guarantee – that it will work as a governance framework. That remains, for now, an unknowable unknown. We suggest, however, that there are two particular features of this mode of governance which should be monitored closely for their role in the success, or otherwise, of this enterprise. These are the Ethics and Governance Framework and the Ethics and Governance Council. Our particular interest in these instruments of governance stems from the fact that they are designed to engage explicitly with values and interests, and from there with participants, other stakeholders and the public at large. Values and Interests in UK Biobank UK Biobank is set up as a not-for-profit company. The organizational arrangements for UK Biobank consist of:

5 www.egcukbiobank.org.uk.


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• a Board of Directors, with representatives of the funders; • a Steering Committee, led by a Chief Executive Officer; • an Ethics and Governance Council, appointed by an open process in keeping with the Nolan Principles; • an International Scientific Advisory Board that meets three times per year. UK Biobank Ethics and Governance Framework At the heart of UK Biobank is the Ethics and Governance Framework (EGF) which outlines the commitments to participants, researchers and society at large, as well as the practices to be adopted in the establishment and management of the UK Biobank resource. The purpose of UK Biobank is articulated in the EGF and this is to build a resource to encourage and facilitate healthrelated research. The EGF explicitly states that: ‘UK Biobank will serve as the steward of the resource, maintaining and building it for the public good in accordance with its purpose’. With respect to the various interests and stakeholders involved, the EGF deals with each in turn. Thus, concerning participants, the instrument lays out in Section I the details of recruitment, the nature of the consent that will be sought, associated guarantees, and the importance attached to protecting participant confidentiality. Section II deals with the relationship with researcher users, focusing in particular on the role of UK Biobank as steward of the data and samples, and detailing the defining principles of the access policy and expectations surrounding the sharing of results obtained through use of the resource. Finally, Section III explores the relationship with society, and articulates matters of internal governance (the roles and responsibilities of the Board of Directors, the Ethics and Governance Council, the Steering Committee and the International Scientific Advisory Board), external governance (the need for approval by relevant ethics committees and compliance with the regulatory regimes), and benefit sharing (being a commitment to disseminate knowledge generally and an account of policies to use intellectual property judiciously and to reinvest any profit back into the resource). From a values perspective, the commitment is to manage the resource for the public good, in keeping with the purposes outlined in the EGF, and while honouring the original consent provided by participants (we say more about the nature of this consent from a values-perspective below). From an interests perspective, the EGF is explicit in identifying both the range of stakeholders and the interests considered to be at stake, but it is important to reiterate, once again, that the EGF is a living instrument designed to evolve with circumstances surrounding the project, and most especially the interests of its stakeholders.

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UK Biobank Ethics and Governance Council The Ethics and Governance Council (EGC) has been established to: • act as an independent guardian of the UK Biobank Ethics and Governance Framework and advise on its revision; • monitor and report publicly on the conformity of the UK Biobank project with the Ethics and Governance Framework; and • advise more generally on the interests of research participants and the general public in relation to UK Biobank. It is the role of the EGC to hold a mirror up to UK Biobank to reflect on its commitments to stakeholders as articulated in the EGF, on an on-going basis and as the project itself develops. The mantra of the EGC is to speak ‘about UK Biobank, not for UK Biobank’. The EGC meets quarterly, holds regular public meetings, reports annually on its work and on its budget, commissions research, maintains a public profile through its website, seeks to engage actively with participants and other sectors of the public about its work and the UK Biobank project, and is ultimately accountable to the funders and the public with respect to these activities and its role in the innovative ‘Ethics+’ approach to governance. While the EGC is not in a position to impose any formal sanctions on UK Biobank or its staff, it is in a position to communicate publicly on any transgressions of the EGF, of the values that it embodies, or of any of the interests of stakeholders engaged in the enterprise. In a very real sense, this breathes life into the old adage that ‘information is power’, and the EGC can be seen to serve as a vital communication bridge between UK Biobank and its participants and other stakeholders. This further serves an important policing function of the relationships that lie at the heart of the EGF. The health and success of these relationships are vital to the success of UK Biobank itself. Building and Maintaining Trust It is axiomatic that UK Biobank depends on people’s willingness to participate and to maintain sufficient confidence in the project not to withdraw from the biobank in the future.6 It is therefore critical to UK Biobank for participants to continue to trust the management and purposes of the biobank over time. Trust may be undermined in a number of respects from a values and interests perspective. Most obviously, this will occur if individuals’ own self interests are not respected or protected, or if it is considered that vested interests hold sway. But the challenge runs far deeper because disregard for the 6 The right to withdraw is an absolute right which is given to all participants in the EGF and which can be exercised at any time and for any reason.


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interests of others might also have an undermining effect, as might a change in the way that the project is run or managed, indicating to participants that the values which once underpinned the project no longer hold true or have been replaced. Learning lessons from the past, Levitt (2003) notes (p. 27) that in the context of GM crops, a lack of transparency and trust between the players (spilling over from the scandal of BSE) gave rise to suspicion about the possible pursuit of vested interests at the expense of the public interest. This resulted in calls for increased transparency, so that people could see how and why particular decisions were being made. In response to this pressure, several organizations have taken to holding at least some of their meetings in public (e.g. the Food Standards Agency). But problems remain. O’Neill (2002) has pointed out that organizations and persons may be worthy of trust but not be trusted. Openness and transparency allied to unrealistic expectations may result in further cynicism and a feeling of ‘it’s just as I feared’ rather than the building up of trust. Transparency might mean that the grosser ‘inappropriate influences’ are kept in the open domain – but this will not necessarily encourage more trust. Transparency is, moreover, often reduced to an obligation of information giving, but since it is never possible to state that one is in possession of all the facts, an element of mistrust may remain. Whether claims are trusted depends, not on facts or information alone – what we might call ‘hard evidence’– but on the kinds of relationship that exist between the parties and, we would submit, the kinds of processes that regulate and respond to dialogue between those parties. Trust, then, is not merely a matter of transparency but is often the result of a relationship. It is perfectly human to trust those with whom we share common beliefs and values, but it is altogether a different matter to determine how to engender trust among those who may disagree with or oppose our values. Acts of transparency are satisfactory only where relationships are already stable, and where there is little reason to doubt the intentions of another. Transparency is therefore unlikely to be the panacea if there is a ‘crisis in trust’ (Brown 2002). Moreover, transparency is rarely constructed as an obligation to articulate one’s values and to demonstrate how these impact on decision-making processes.7 Openness in the basis for decision-making can, however, allow the making explicit of the basis for balancing pros and cons; benefits and risks; different interests and different value-preferences. Earle (2004) identified two general theories of how people construct a basis for trust: 1) trust is based on observed objectivity and fairness and perhaps also competence and expertise; 2) trust is based on individual judgement and consciously connected with agreement or disagreement, based on, for example, 7 Far more common is the creation and publication of a register of interests, although this is primarily, if not solely, done to flag any actual or perceived conflicts of interest.

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inferred values and quality of the organization. Thus, in at least one sense the sharing of values, or indeed the recognition of one’s value-stance (and that of others), is an important element in building a relationship of trust. The importance of articulating and seeking to respect various value-stances in the decision-making processes with respect to scientific and technological developments is crucial. This provides not only a framework in which decisions can be taken cognizant of the range of values in play, but it also allows consistency of decisions over time. Consistency is an important element of any trust relationship. Furthermore, an obligation to express clearly one’s value-stance necessitates reflexivity, that is, self-reflection on what exactly it means to hold such a value and where its limits lie. It is in the territory between value positions that effective, reasonable, legitimate and legitimated policy is to be found. UK Biobank recognizes the requirement to earn the trust of participants and a number of governance features are in place to enable openness, to establish trust relationships and to encourage reflexivity in how those relationships are maintained over time. The Ethics and Governance Framework is a clear articulation of the value basis upon which the model of governance was established and of how different ethical principles have been negotiated. The Ethics and Governance Council publishes the minutes of its meetings and these not only record decisions taken but also attempt to convey the processes of deliberation and reasoning undertaken by the Council. Furthermore, on agreement but acting independently, UK Biobank and the Ethics and Governance Council record and explain advice and actions that have required changes to the Ethics and Governance Framework and/ or consent documentation, and a recent example is the revision of the ‘No Further Use’ option linked to the right to withdraw. This required change because of technical features of the UK Biobank data archival system which mean that it is not possible to destroy all data completely on withdrawal as was once thought.8 Some data must remain for audit and archival purposes, but the nature of the original guarantee to participants – that there will be no further use of their data for the purposes of the resource – has not changed. This last example is one which demonstrates what we mean by reflexive governance. The EGC was able to respond to an eventuality which was not, and could not have been, foreseen when the project was set up and the Ethics and Governance Framework established. As a result of a close examination of the issue and the fundamental values and interests at stake, the EGF and consent documentation have been amended, and – just as importantly – these processes and deliberations have been explained and described.

8 See UK Biobank: and Ethics and Governance Council: .


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This also speaks to a further challenge for UK Biobank in maintaining trust, which is to demonstrate that it is managed with integrity and consistent with its principles. The Board and funding bodies have a role in this respect but the addition of the independent Ethics and Governance Council provides a further layer of security. Trust, however, is a fragile thing and the benefits of biobanks are in the future and largely uncertain. The way in which information about the future benefits of UK Biobank are communicated and the types of futures that are projected can potentially have an impact on the trust that is placed in UK Biobank. Will it deliver what was promised? The uncertainty around the developments that may be realized through UK Biobank are to a large extent a source of hope (rather than risk as in some other biotechnological developments such as GM crops). Care is needed, however, not to allow ‘hope’ to spill over into unrealisable ‘hype’. Providing Choice Another way of incorporating values in processes is to allow individuals to make choices among a range of options. The privileging of choice is an important contemporary example of how different values may be, and are, prioritized in science and technology. Choice has become the watchword of consumer demand and the key measure of respect for individuals. Thus choice can become the overriding value under which many, or all, other values are to be subsumed. Moreover, free choice, such as the choice whether or not to participate in a biobank project, is seen by many as the only acceptable approach to such projects, and was undoubtedly the value basis upon which many objected to the opt-out approach of the Icelandic Health Sector Database. Prudently, perhaps, UK Biobank adopts an opt-in model. The main benefit of enabling choice as a governance tool is to allow individuals to make their own decisions in ways that reflect their own values and interests. But choice as a governance mechanism brings its own challenges, both practically and from a values and interests perspective. For one thing, it is by no means a trivial exercise to persuade 500,000 to sign up to a research project, let alone one which will continue for an indeterminate length of time. Furthermore, while ‘better choice’ is almost universally equated with ‘informed choice’, more information does not always unproblematically facilitate choice. Indeed, in the context of longitudinal projects like UK Biobank, fully informed choice is not achievable because there are simply too many uncertainties about the future of the resource, including who will seek access, from where, and for what purposes? This raises a question from an interests perspective as to whether the interests of individual participants are sufficiently protected; more fundamentally, and from a values perspective, it might make a project such as UK Biobank non-viable if we insist that the only acceptable value-basis for its operation is free, fully-informed consent. But this is not the value-basis upon which UK

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Biobank has been established. The Ethics and Governance Framework makes it clear that there are future uncertainties and it is not possible to explain all eventualities at the time of recruitment. The invitation is ‘to participate in UK Biobank’ with everything that this entails. The value-basis of UK Biobank is to establish a research resource for future health-related research for the benefit of future generations. The future-oriented nature of the project has a potential impact on the interests of participants in that they cannot be fully informed at the time of recruitment. In a sense, UK Biobank is asking participants to be other-regarding. By the same token, additional safeguards are built into the governance mechanism to protect participants’ own interests, including a commitment from UK Biobank to update participants with information about the project as and when it develops, and the existence of an absolute right to withdraw from the project at any time and for any (or no) reason. Again, from a values and interests point of view this can be seen as serving complementary functions. Clearly individuals can withdraw if they consider that their own interests are at risk or have been compromised, but the right to withdraw might also serve as a means to signal a value-judgement on the project – an expression of disapproval or a message that the relationship between the project and its stakeholders is no longer working. Choice, then, can be an important governance tool and one that involves some degree of empowerment of participants as stakeholders. In the UK Biobank context choice and trust are closely allied, in the sense that choice in favour of UK Biobank is a measure of trust in the project. The options that it offers are, however, somewhat limited: the choice to participate (or not); the choice to withdraw (or not). In particular, choice does not necessarily give you a voice. Withdrawal is the ‘nuclear option’. And, while it may only be a last option, it is certainly not an optimal option if negotiation of perspectives is thought to be important and desirable as a means to address and resolve conflict and avoid the ultimate choice to withdraw. By the time such a choice is exercised, it is too late for the process of governance. It may even be seen as a failure of governance. This is why we advocate reflexive governance which must involve mechanisms to measure and gauge participants’ (and public) attitudes and to understand what is informing their choices. This gives governance mechanisms the best chance to respond appropriately and timeously to concerns or conflict, and, perhaps, to pre-empt the exercise of the ultimate choice. To do this effectively, some degree of public and participant engagement is required. The Role of Public and Participant Engagement We can find plenty of evidence in the wider international life sciences arena that policy makers clearly believe that wider participation in decision-making


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processes will create more confidence in the resulting policies and in the institutions that deliver them: The quality, relevance and effectiveness of EU policies depend on ensuring wide participation throughout the policy chain – from conception to implementation. (Commission of the European Communities 2001, 10)

But in the UK, interaction with stakeholders, including the public, has traditionally been seen as consulting in an ad hoc way on each particular issue rather than as an ongoing interaction. There is still a tendency for government departments to equate ‘consultation’ with ‘engagement’ (Lyall 2005) rather than to adopt a genuine commitment to user-involvement that goes beyond merely offering the opportunity to ‘participate in participation’ (de la Mothe 2001, 8). Reflecting a trend we have identified with other governance tools, the discourse of participation has often been about crisis management: a largely predetermined range of remedial or damage-limitation options is presented as a means of resolution (Rayner 2003). The funders of UK Biobank have themselves been criticized for their early approaches to consultation,9 although it should be noted that the Ethics and Governance Framework was put out for public comment, and the Ethics and Governance Council has commissioned research on publics’ and participants’ attitudes towards access and commercialization (see further below). The advantages of such a participative approach may include (Cameron and Danson 2000): • increasingly innovative policies and better operational decisions arising from dialogue between organizations with different perspectives on problems; • increased continuity and consistency in policy and decision-making; • high level strategic planning and decision-making through shared agreement. The participative governance approach advocates an increasing role for nongovernmental actors and stakeholders in policy and decision-making, often as a means to mitigate public controversy over new technology developments (Lyall and Tait 2005, 182). Studies of participative exercises have suggested (STAGE 2004) that often the main motivation for sponsors of deliberative processes is the desire to achieve social consensus on a development and retain or regain public trust. From our perspective, the major criticism is that the prevailing model may still be more to do with casting stakeholders and 9 Tutton, Kaye and Hoeyer (2004) urged funders ‘… to consider the inclusion of representatives of the participants in the EGC and other management bodies as a way of securing public trust and support’.

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publics as interest groups who must be satisfied (but who may, in reality, be polarized), and reducing policy conflicts by controlling the message rather than communicating with, and listening to, stakeholders and publics. Indeed, the process may overlook the fact that policy-making is about dialogue (Parsons 2001). A considerable amount of public engagement has taken place during the development of UK Biobank (Levitt 2005). Initially, this was primarily in order to understand what issues are important to potential donors to the biobank and to test out what kind of governance and other arrangements would prove acceptable. Thus, initial consultations were carried out from 2000–2003 and helped to inform the work of the Interim Advisory Group, while its main output – the draft Ethics and Governance Framework – was also put out for public consultation in 2003. Since the launch of the project and the establishment of the Ethics and Governance Council, UK Biobank has employed a Communications Officer and the EGC has held regular public meetings, the results of which – in terms of questions asked, answers given and actions undertaken – are reported publicly in its Annual Reports and on its website. Perhaps most significantly, and as a measure of the independence of the EGC, it has commissioned research on public attitudes towards UK Biobank’s stated access policy and the prospect of commercialization of research arising from the resource. This was undertaken after a scoping paper (Sumner 2007) identified a gap in the social science literature on these topics and in light of evidence from other studies revealing public concerns about commercialization (Haddow et al. 2007). Considering these exercises in governance terms, we can ask: what kind of evidence does public participation provide? Scientists and others may be critical of the contribution of public participation because they may perceive the public as emotional rather than rational and open to manipulation by self-interested opponents (e.g. Cook et al. 2004).We should however also note, after Weber (1968), that ‘rationality’, can be understood in different ways. The more common concept of ‘instrumental rationality’ involves weighing up consequences of different actions, as in the case of cost-benefit analysis, for example. In the concept of ‘value rationality’, by contrast, actions are consistent with a particular ‘value’ position. As Weber points out, ‘valuerational’ actions appear to be irrational from the perspective of ‘instrumental rationality’, and the more strongly a ‘value’ position becomes held for its own sake rather than because of its consequences, the more irrational this will appear from the perspective of ‘instrumental rationality’. Moreover, if all that is observed is the ‘irrationality’ without an understanding of its underlying cause or reason – that is, of the ‘value’ informing the position – then it becomes easier to dismiss that position rather than to engage further with it. The process then ceases to function as a dynamic, interactive model. Indeed, the model itself may be set up to bring about just such an eventuality by preferencing one view of rationality over another.


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What do the public engagement exercises relating to UK Biobank tell us? We can, of course, answer this at a specific or a general level of abstraction. They tell us, for example, that public awareness of UK Biobank is not terribly high, but that there is evidence of respectably high levels of satisfaction among groups informed about the general governance mechanisms of the project. Equally, it seems that there are no statistically significant differences between attitudes among survey participants in the UK Biobank age range (40–69) and a younger generation (18–30). There is, however, some evidence of higher levels of concern about international applications to use the resource (although we do not know what lies at the root of such concern), and there is also some indication that the prospect of commercialization continues to be a cause of concern (but again, the root cause remains elusive). We recognize the importance of such engagement exercises for both UK Biobank (in managing the project) and the EGC (in exercising its advisory role). Although, once again, they are limited from a values and interests perspective: they do not tell us if, or when, or how, attitudes might shift, nor where publics’ tolerances lie with respect to particular policy or management decisions. They are nonrepresentative snapshots in time; and, while they might be repeatable over time and with diverse groups to minimize this limitation, they may be too crude a mechanism to gauge subtle changes in values and interests. Short of offering representation within UK Biobank,10 yet other complementary mechanisms may be required to fulfil this role. Ethical Committees and Ethical Experts Ethical committees have come to play a key role in arbitrating some areas of genomic technologies and in particular to act as ‘gate-keepers’ to the technology. These committees have traditionally been used in health care and animal research but are now extending to cover wider areas. Additionally, medical research has historically included a layer of ethical approval, which could be understood as an early form of governance (in that membership of ethical committees includes a wider network of actors) or as an additional form of government (in that failure to satisfy the ethics committee means that the research will not proceed – in this sense, it is a top-down ‘regulatory’ tool). Others, such as the Human Genetics Commission, have a wide strategic remit and an advisory role. Ethical committees might be seen as a way of managing morality (as opposed to managing different risks as is the function of much of government). The establishment of the UK Biobank Ethics and Governance Council represents yet another kind of body – one which is non-governmental and non-regulatory, independent and yet financed by research funders, and 10 See Winickoff (2007). We do not have space or time to engage with these arguments, see rather, Hunter (forthcoming).

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with a very particular remit, to advise and monitor one particular science project. It is something of an enigma in governance terms. Its value remains to be proven, but we consider that it potentially has much to contribute as a key element in models of reflexive governance, as we suggest below. The example of the UK Biobank Ethics and Governance Council takes this kind of governance role many stages forward and hence we have coined the terminology of ‘Ethics+’. For one thing, it has an on-going advisory and monitoring role with respect to the research, helping to ensure that it remains ethical. Ethics Committees simply provide up-front, one-off approval. Secondly, and again unlike ethics committees, the dealings of the Ethics and Governance Council are made public by a variety of routes, including published minutes of its meetings, full accounts of its deliberations, and public engagement activities to inform publics about its role and to gauge attitudes (and possible concerns) about UK Biobank. The EGC also has a responsibility to respond to the input it receives, and does so in its annual reports and through its website, where Frequently Asked Questions about its role and advice appear and these are regularly updated as new questions and queries emerge. Finally, the EGC is committed to making explicit the basis for much of its reasoning and what informs its advisory and monitoring role: for example, it has produced documentation that explores and explains its approach to ‘advising in the public interest’, which is central to its remit. This kind of engagement and explanation of process is also central to how we view reflexive governance. Without it, we suggest, the dangers of fragmentation of debate and the stalling of policy and decision-making processes may quickly and easily come to the fore. Processes may be fractured along values and interests lines. We suggest that a key feature of any system must, however, be a genuine, transparent and consistent commitment to receive value-based and interestbased inputs at all stages and an openness to the possibility that these might change the technology or policy trajectory, as far as this is practicable. We acknowledge, however, that once the direction is clear, it may be too late to change; and, even when it is possible to change things, we do not always know what direction we then wish to take. Notwithstanding, the task is about optimizing the process through the fullest possible engagement with interest and value perspectives. We contend that allowing arguments to be expressed and addressed for what they are – that is, on a value-base or alternative future base approach – could remove some of the heat currently placed on ‘scientific’ evidence. We have indicated above that it is not possible or realistic to attempt to satisfy all positions that may be voiced with respect to any life science initiative – either now or over time; indeed, these will doubtless shift as time and society moves on. We cannot, then, ever expect to future-proof governance. We have argued, however, that in the context of UK Biobank a new model of governance has emerged – or is at least emerging – and this is reflexive governance. It is typified


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by on-going engagement with values and interests, responsive and explicit advice and monitoring, and a commitment to explain why particular policy or decisions have been adopted such that this is, at the very least, understandable to a majority of reasonable persons. In this last regard we refer to the work of Daniels (1985, and Daniels and Sabin 2002) for his approach represents one further means of accommodation in value-based conflicts which helps to avoid possible stalemates. In the context of allocation of scarce health resources, he advocates a fair, deliberative process of setting limits on difficult decisions where it is impossible to satisfy all parties. The process is typified by clear articulation of criteria for decision-making, transparency at every level, and an overall aim to reach decisions which are acceptable to (all) reasonable persons because the reasons (and values) behind them are at least understood, even if they are not agreed with. It has been suggested more recently that this process can and should be complemented by public consultation (WilliamsJones and Burgess 2004). We suggest, in turn, that precisely such an approach is now evident in the governance model applied to UK Biobank, and that much will be learned about governance as a result. Conclusion Scientific evidence has been used as a rationalist way of providing a basis for government. However, where powerful technologies are raising fundamental questions about our social fabric and our fundamental values, scientific evidence no longer provides a sufficient basis for government, and government no longer provides a sufficient basis for moulding scientific and technological developments. Different perspectives and alternative conceptions of the future are becoming increasingly important and require incorporation in any decision-making or policy-making process. Disagreements on the basis of differing value perspectives have traditionally been a recipe for stalemate. We suggest that part of the reason for this arises, first, from the prevailing model itself; and second, from a failure to engage more fully with the nature and substance of such perspectives. We need to be able to recognize the potential for value-based conflict at a much earlier stage in the technology trajectory and to create spaces where these aspects can be explored as the trajectory develops. This implies in essence a governance mode of action, and more particularly a mode of reflexive governance. We should take care not to reduce a problem prematurely to a limited set of dimensions established by dominant experts. Time should be taken to explore a range of aspects and to test a range of boundaries to a problem. The first step in engaging with values is the recognition that they exist everywhere, sometimes explicitly, but at other times implicitly. Where values are a key element, we should not ignore them nor force them to be expressed in terms of ‘scientific evidence’ but rather we should find a lexicon for talking

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about them openly in the same way that we now do about ‘risk’. This does not mean rejecting scientific evidence, but rather it means re-envisioning science as but one, albeit essential, ingredient of the decision-making mix; as evidence to be enriched by other knowledge from different spheres and leavened by an explicit acknowledgement of the values that exist in society. We must make the implicit, explicit. Consulting on values does not, of course, inevitably mean that we arrive at a shared value position. Such an assumption would be naïve in the extreme. Sometimes good communication can take place and we discover that there are real value differences with very real consequences. Consultation does not take away the need for political judgements about the future direction to be taken. We started out by identifying that in a governance model collaboration is needed to identify what matters, evidence to discover what works and ultimately what matters is what works. In our example of UK Biobank, collaboration by various stakeholders (including potential and actual participants) is used to identify what matters. A framework has been developed for the governance of UK Biobank but within it is included reflexivity that will allow amendments to be made when deemed necessary and an approach that makes the value-basis of decisions open and explicit. UK Biobank is still in its formative stages with a primary focus on participants. The robustness of the model when strongly challenged by other stakeholders, such as industry or plans for unexpected research avenues from research scientists has yet to be fully-tested. UK Biobank and its innovative ‘Ethics+’ approach to governance provides an interesting example of where government and governance approaches have been adopted in practice in a potentially contentious area of the life sciences. UK Biobank has combined ‘hard’ government in terms of protecting the interests of participants as well as ‘soft’ governance taking into account different values and interests and ensuring continuing participation by members of the public in the biobank and its governance processes. This illustrates the way in which government and governance are not functioning as two poles of a continuum nor as two completely intertwined entities, but as a ‘soft’ wrapping of governance around a ‘hard’ core of government. It is inconceivable that ‘government’ alone would provide a sufficient basis for the establishment of the biobank. It requires the active participation of publics and clinicians and in a modern democracy these cannot be obtained by central government edict. On the other hand the legislative framework has provided a layer of protection to participants without which trust in the biobank would be unlikely to be gained. UK Biobank has made explicit the value basis on which it plans to function in the form of its Ethics and Governance Framework and to date has explained publicly the reasons for any changes in this framework. The UK Biobank Ethics and Governance Council does the same in its role as advisory and monitoring body. The future success of UK Biobank remains to be seen, but – whatever the outcome – much will be learned from the journey.


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Acknowledgement With thanks to Adrienne Hunt, Secretary of the UK Biobank Ethics and Governance Council for checking this chapter for accuracy. References Bache, I. (2003), ‘Governing through Governance: Education Policy Control under New Labour’, Public Administration 78:3, 575–92. Brown, N. (2002), ‘Transparency – the Very Idea’, transcript of a paper presented at the Royal Society of Arts seminar on Transparency and Corporate Life, 19 September. Bruce, A. and Tait, J. (2003), ‘Interests, Values and Biotechnological Risk’, in Andersson, K. (ed.) Values in Decisions on Risk, Proceedings of a conference held in Stockholm, 9–13 June. Bruce, A. and Tait, J. (2004), ‘Interests, Values and Genetic Databases’, in Amason, G., Nordal, S. and Amason, V. (eds) Blood and Data: Ethical, Legal and Social Aspects of Human Genetic Databases, International ELSAGEN Conference Proceedings, Reykjavik, 211–17. Burton, J. (1990), Conflict: Resolution and Prevention. (Basingstoke and London: The Macmillan Press). Cameron, G. and Danson, M. (2000), ‘The European Partnership Model and the Changing Role of Regional Development Agencies: A Regional Development and Organisation Perspective’, in Danson, M., Halkier, H. and Cameron, G. (eds) Governance, Institutional Change and Regional Development. (Aldershot: Ashgate). Commission of the European Communities (2001), European Governance: a White Paper (Brussels: Commission of the European Communities). Cook, G., Pieri, E. and Robbins, P.T. (2004), ‘“The Scientists Think and the public feels”: Expert Perceptions of the Discourse of GM Foods’, Discourse and Society 15:4, 433–49. Daniels, N. (1985), Just Health Care (New York: Cambridge University Press). Daniels, N. and Sabin, J.E. (2002), Setting Limits Fairly: Can We Learn to Share Medical Resources? (New York: Oxford University Press). Department of Health (2003), Our Inheritance, Our Future. Realising the Potential of Genetics in the NHS (CM 5791–II). Earle, T.C. (2004), ‘Thinking Aloud about Trust: A Protocol Analysis of Trust in Risk Management’, Risk Analysis 24:1, 169–83. GeneWatch UK (2002), ‘Genetics and “Preventative Medicine”: Selling Pills, Ignoring Causes’, briefing document. Gertz, R. (2004), ‘An Analysis of the Icelandic Supreme Court Judgement on the Health Sector Database Act’, SCRIPTed 1:2, 241.

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Haddow, G., Laurie, G., Cunningham-Burley, S. and Hunter, K. (2007), ‘Tackling Community Concerns About Commercialisation and Genetic Research: A Modest Interdisciplinary Proposal’, Social Science and Medicine 64, 272–82. HM Government (1999), Modernising Government (White Paper, London). Hoeyer, K. (2004), ‘The Emergence of an Entitlement Framework for Stored Tissue – Elements and Implications of an Escalating Conflict in Sweden’, Science Studies 17:2, 63–82. Human Genetics Commission (2003), Memorandum to the House of Commons Science and Technology Committee on Medical Research Council/ Wellcome Trust/Department of Health UK Biobank study, available online at . Hunter, K.G. (forthcoming), ‘Involving Publics in Biobank Governance: A Stakeholder Approach?’, in Widdows, H. and Mullen, C. (eds), The Governance of Genetic Information: Who Decides? (Cambridge: Cambridge University Press). Levitt, M. (2005), ‘UK Biobank: A Model for Public Engagement?’, Genomics, Society and Policy 1:3, 78–81. Levitt, R. (2003), ‘GM Crops and Foods. Evidence, Policy and Practice in the UK: A Case Study’, Evidence Network Working Paper 20 (ESRC UK Centre for Evidence Based Policy and Practice). Lyall, C. (2005), ‘Changing Boundaries: The Role of Policy Networks in the Multi-level Governance of Science and Innovation in Scotland’, Science and Public Policy 34:1, 3–14. Lyall, C. and Tait, J. (eds) (2005), New Modes of Governance: Developing an Integrated Policy Approach to Science, Technology, Risk and the Environment (Aldershot: Ashgate). Mothe, J. de la (2001), ‘Knowledge, Politics and Governance’ in Mothe, J. de la (ed.), Science, Technology and Governance (London: Continuum). Newman, J. (2001), Modernising Governance. New Labour, Policy and Society (London: Sage). Nutley, S. and Webb J. (2000), ‘Evidence and the Policy Process. What Works?’ in Davies, H.T.O., Nutley, S.M. and Smith, P.C. (eds), Evidence-Based Policy and Practice in Public Services. (Bristol: Policy Press). O’Neill, O. (2002), Autonomy and Trust in Bioethics (Cambridge: Cambridge University Press). Parsons, W. (2001), ‘Modernising Policy-making for the Twenty-first Century: The Professional Model’, Public Policy and Administration 16:3, 93–110. Pielke, R.A. (2007), The Honest Broker. Making Sense of Science in Policy and Politics (Cambridge: Cambridge University Press,). Rayner, S. (2003), ‘Democracy in the Age of Assessment: Reflections on the Roles of Expertise and Democracy in Public-Sector Decision Making’, Science and Public Policy 30:3, 163–70.


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Rose, H. (2003), ‘An Ethical Dilemma. The Rise and Fall of UmanGenomics – the Model Biotech Company?’ Nature 425, September, 123–4. Solesbury, W. (2001), Evidence Based Policy: Whence it Came and Where it’s Going, Working Paper No 1. (London: ESRC UK Centre for Evidence Based Policy and Practice). STAGE (2004), STAGE Closing Conference, Friday 26 November. (Royal Institution of Great Britain), <www.stage-research.net>. Sumner, J. (2007), ‘Public Attitudes towards Biobanks and Related Ethics and Governance Issues’, . Tait, J. (2001), ‘More Faust than Frankenstein: The European Debate about the Precautionary Principle and Risk Regulation for Genetically Modified Crops’, Journal of Risk Research 4:2, 175–89. Tait, J. (2004), ‘Science and Bias’, EGenIS lecture 6 September, . Tutton, R, Kaye, J. and Hoeyer, K. (2004), ‘Governing UK Biobank: The Importance of Ensuring Public Trust’ Trends in Biotechnology 22:6, 284–5. Weber, M. (1968), Economy and Society (New York: Bedminster Press). Williams-Jones, B. and Burgess, M.M. (2004), ‘Social Contract Theory and Just Decision Making: Lessons from Genetic Testing for BRCA Mutations’, Kennedy Institute of Ethics Journal 14:2, 115–42. Winickoff, D.E. (2007), ‘Partnership in UK Biobank: A Third Way for Genomic Property?’, Journal of Law, Medicine and Ethics 35:3, 440–56.


Chapter 4

Governing Reproductive Treatment and Research: From the Moral to the Political to the Legal – and Back Again? Or ‘There and Back Again, a Regulator’s (Hobbit’s) Odyssey (Holiday)’ Shawn H.E. Harmon

Introduction Reproductive medicine and research, specifically in vitro fertilization (IVF) and embryonic research, are constituent parts of human genomics, a life science which is expanding and subversive, leaking into a variety of arenas, from environmental protection to food production to healthcare delivery, and more, and in so doing is reshaping our relationship with those arenas. The genomic elements of reproductive medicine in particular have incited as much moral consternation as they have medical excitement and hyperbole, raising concerns about family/kinship and human relatedness, wellbeing/safety and identity, and the Promethean nature of their processes (Jonas 1984; Singer and Well 1984; Strathern et al. 1993). Given the above, although most medical practices are undertaken outside express legislative control, and although there has long existed a (vague) realm of activity viewed as appropriately governed by private morality and not the law (Wolfenden Report 1957, para. 257), there emerged calls for legal intervention. These demands are, perhaps, unsurprising given the intimate relationship between reproductive genomics and human health, and the close connection of the latter to our hopes for, and ideas of, self. Indeed, it is the nature of this relationship which suggests not only that regulatory instruments ought to exist, but that they ought to have an explicit moral foundation which is effectively translated into legal rules. It also suggests that the regulatory framework’s formulative process should be inclusive, risk-aware and future-oriented, so that the ultimate regime settled upon is responsive but proactive, and strong but flexible. This chapter considers the creation and content of the UK Human Fertilisation and Embryology Act 1990 (HFEA 1990) and its Human Fertilisation and Embryology (Research Purposes) Regulations 2001 (2001 Regulations)

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with a view to (1) considering how successful this legislative effort was at generating morally grounded rules reflective of the moral controversies that persist in the reproductive medicine and research field, and (2) querying where its pre-legislative preparatory efforts and post-adoption processes sit on the government-governance continuum. In short, it examines a case study through both the ‘moral/bioethical’ and the ‘government/governance’ lenses so as to evaluate the origin and the ongoing impact of this regime. However, before doing so, it is appropriate to set the stage by briefly reviewing the benchmark event of reproductive medicine and some of its fallout. The Moral – from Patient Zero to the Future: Repercussions of Reproductive Medicine and Reproductive Research In 1978 reproductive genetic science produced the first ‘test-tube baby’ – Louise Brown from Oldham, Lancashire. That first IVF success aroused feelings of pride in the new technological achievement, pleasure in the new means to treat infertility, and anxiety at the potential unchecked advance of science; it aroused a maelstrom of conflicting emotions and visions of the future. It is claimed that ‘IVF was the founding episode of the “biology revolution”, paving the way for gene therapy, genetic engineering and cloning’ (Seguin 2001, 199). Certainly, it served as a precursor to the dramatic advances and excited responses of the ‘genetic age’ that followed, and is recognisable as a product of the ‘risk society’ insofar as it constituted a complex cluster of social, legal and moral issues which were of deep concern to those both directly invested and not at all invested in the practice. Although some issues and arguments would take time to develop and to bubble to the discursive surface, that first IVF success was the progenitor of (still current) questions about the meaning and timing of ‘personhood’ and the extent to which we should undertake actions potentially destructive of early human life. A variety of stakeholders (philosophical, religious, social, political and scientific) advanced a plethora of opinions about the time at which something becomes a ‘person’ entitled to the special status and protections that title endows; candidates were conception, emergence of the primitive streak, quickening, viability, birth and post-birth (the last dependent on the qualities one accepts as being core to the human experience). Other issues, some of them driven by the fact that Louise Brown was conceived and born into a legal vacuum, include: • the nature and causes of infertility and its treatment;1

• the propriety of assisted contraception; 1 Infertility can be attributed to anatomical, physiological and pathological causes, but can also be related to prior use of contraception, medication, abortion, or

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• the status of processes aimed at infertility and the propriety of undertaking research relating to same within the healthcare delivery system; • the role and position of scientists in healthcare, and the fear that irresponsible scientists might use new techniques to predetermine human characteristics, clone humans, or create hybrid creatures; • the special impact on women of infertility processes and research; and • the shifting nature of family, kinship and human relatedness, and the state’s role in preserving existing formulations or permitting/advancing new ones. In short, this singular IVF success, and those that followed it, raised social, scientific, legal, and, as noted above, ethical, questions, and served as a lightning rod for a variety of publicly aired concerns over the direction of reproductive medicine and biotechnology more generally. Answers to these questions/concerns are fundamental to determining the ethical use of, access to, and boundaries for, reproductive technologies, and two broad approaches moved to the fore in framing and addressing these issues. The first approach was a rights-based one, which evolved from Dworkin’s (1993, 148) abortion-driven definition of procreative autonomy as an individual right to control one’s procreation unless the state has a compelling reason to intervene. Harris (1998, 34–6) suggests that procreative autonomy might extend to assisted conception, which would suggest a right to reproduce in ways that express our reproductive choices (i.e. that give rise to the sort of people we think it right to create), and that the state should only limit that right for compelling reasons (i.e. meaning the state must show more than that a majority of people find the idea disturbing). Although debates persist over whether procreative autonomy properly implicates a negative or a positive right (as do questions about the implications of erecting a right to procreate2), the general conception is justified on the basis that procreative decisions are central to personal identity and dignity, and to values and life objectives (Robertson 1994, 24).3 The second broad approach came from the feminists, who advanced a number of interrelated strands each organized around concerns over procreation, parenthood, and the nature of family and personal identity, and surgery, or to environmental conditions such as alcoholism, drug abuse, poor nutrition, stress, and environmental toxins (Edelmann and Golombok 1989). 2 Brazier (1998, 72) cautions that if women have a right to procreate, then so probably do men, which has dire implications for women’s procreative autonomy. 3 For more on procreative rights, see Hon. Justice Hale, From the Test Tube to the Coffin: Choice and Regulation in Private Life (London, Sweet and Maxwell, 1996), K. Mason, Medico-Legal Aspects of Parenthood and Reproduction, 2nd edn (Aldershot, Ashgate, 1998), and others.

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each framed by criticisms of patriarchy and by the questioning of science neutrality and technological certainty, the latter of which are often assumed, but which are rightly contested by feminists. In each case, they share a number of characteristics: … First, there is a general scepticism or rejection of the biomedical model of medicine. Secondly … is a belief that whether reproductive technologies are the wrong set of responses to the wrong set of problems, or whether at best they promise a limited set of successful outcomes for a very limited set of questions for a limited set of people, there is nonetheless something to be understood about the appeal that they have. Third, there is a belief … that where reproductive technologies do properly have a place … they should be free from explicit manipulation by the state to secure other, underlying policy goals which exist for the benefit of the state rather than for … the individual …. (Lee and Morgan 2001, 33)

Additionally, feminists highlight the fact that reproductive health and the protection of reproductive choice for women must address both prevention of unwanted pregnancy and circumvention of unwanted childlessness, both of which are conceptually connected. Obviously, the variety and consequences of analyses were (and remain) multitudinous, and this is not the place to rehearse them. Suffice to say that from the late 1970s onward, and increasingly so in the present, many aspects of the reproductive life sciences have been tied to the moral – they excite moral concerns, implicate moral welfare, face moral challenges, and demand moral justifications – and therefore they generate moral politics. Thus, it should have come as little surprise that the moral debates spawned by Louise Brown would trigger political action shortly thereafter. The Political/Legal – from Warnock to the HFEA: The Process and Content of the Reproductive Medicine Regime Investigation: Conception of the Morally Plural Warnock Report In July 1982, the British parliament established the Committee of Inquiry into Human Fertilisation and Embryology (Warnock Committee), a policy mechanism which had been in decline, with a remit of: considering recent and potential developments in medicine and science related to human fertilization and embryology; considering what policies and safeguards should be applied, including considering the social, ethical and legal implications of these developments; and making recommendations with a view toward legislation. The Warnock Committee, chaired by (then) Dame Mary Warnock, an Oxbridge philosopher, contained seven doctors/researchers, three lawyers,


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two social workers, a theologian, a health administrator and an entrepreneur. From the outset, it understood that it was undertaking a sensitive task in a morally charged and controversial field, and that its work would be closely scrutinized and criticized. As such, it considered one of its primary tasks to be the collection of scientific, social and lay evidence, for very little existed at the time, ultimately hearing some 21 oral representations, considering written evidence from hundreds of interested individuals and organizations working in the reproductive and related research fields, and additionally receiving 695 letters and submissions from the public. The Warnock Committee approached its work by separating it into two broad categories, one directed at infertility-remedying processes beneficial to individuals, and the other directed at knowledge-generating research beneficial to society more generally. It soon became apparent that the central questions turned on the value to be given to human life, and the degree to which the law should protect the embryo: … [T]he question was not … whether the embryo was alive and human, or whether, if implanted, it might eventually become a full human being. We conceded that all these things were true. We nevertheless argued that, in practical terms, a collection of four or sixteen cells was so different from a full human being, from a new human baby or a fully formed human foetus, that it might quite legitimately be used as a means to an end that was good for other humans, both now and in the future. This, then, was a matter of judgment; and no-one would deny that it was a moral judgment. What was being weighed up was certain human goods on the one hand and the status of these collections of cells on the other. (Warnock 1985, xv)

Warnock goes on to state: All the other issues we had to consider seemed relatively trivial compared with this one, concerned as it is with a matter which nobody could deny is of central moral significance, the value of human life. Without agreed rules … the Committee was obliged to use a mixture of utilitarian considerations and of judgment. (Warnock 1985, xvi)

Unsurprisingly, the evidence offered was morally diverse, meaning that it would be impossible to satisfy all interested persons: Members of the [Committee] were reluctant to appear to dictate on matters of morals to the public at large. They were also keenly aware that no expression of their own feelings would be a credible basis for recommendations, even if they all felt exactly alike. As our reading of the evidence showed us, feelings among the public … run very high in these matters; feelings are also very diverse …. (Warnock 1985, 1)

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In the result, the Warnock Committee (or a majority thereof) settled on a compromise between sacralization and instrumentalization, concluding that the human embryo had a ‘special status’ entitling it to ‘some protection in law’, and the Warnock Committee thereby reflected its general feeling that, while the law must not outrage the feelings of too many people, it could not possibly reflect the feelings of them all (Warnock 1985, xvi and 63). In short, on the key question of personhood, it held that there is no absolute point at which a person materializes and obtains full moral status. Rather it is a gradual and cumulative process. Despite the diversity of opinion on the moral status issue, the evidence put before the Warnock Committee was consistent insofar as it made clear that people wanted some principles to govern the development and use of new reproductive technologies (Warnock 1985, 2). Thus, although it considered that its (majority) position would serve as a sufficient moral foundation for any law that might follow (i.e. a moral foundation through which it could find public support and by which it could be defended), it understood that it needed to couch its recommendations with a view to a workable legal output: We were obliged … to bear in mind that any law must be generally seen as beneficial, that it must be intelligible and that it must be enforceable. (Warnock 1985, xvi)

In short, some certain, identifiable point was needed beyond which instrumental actions could no longer be taken, even though full juridical status would have to wait until an infant is born alive. As such, with respect to research, the Warnock Committee opined that: Legislation should provide that research may be carried on any embryo resulting from in vitro fertilisation, whatever its provenance, up to the end of the fourteenth day after fertilisation, but subject to all other restrictions as may be imposed by the licensing body. (Warnock 1985, 84)

Additionally, it criminalized the handling of, or research on, embryos after this period, the licensing of trans-species and hybrid fertilization, and the unauthorized sale or purchase of gametes or embryos. On the comparatively ‘trivial’ matter of access to assisted contraception and limits thereto, the Warnock Committee held as follows: To judge from the evidence, many people believe that the interests of the child dictate that it should be born into a home where there is a loving, stable, heterosexual relationship and that, therefore, the deliberate creation of a child for a woman who is not a partner in such a relationship is morally wrong. … [W]e believe that as a general rule it is better for children to be born into a two-parent family, with both father and mother, although we


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recognise that it is impossible to predict … how lasting such a relationship will be. (Warnock 1985, 11–12)4

The Warnock Committee published its Report in July 1984 and was criticized on grounds that it (1) relied on incompatible moral positions, (2) proposed arbitrary limits, and (3) permitted acts offensive to large segments of society. Despite these criticisms, it cannot be denied that the Warnock Committee identified the core issue (i.e. the need to develop public trust in the face of novel scientific procedures whose ultimate effects on society will be unpredictable), and helpfully explored the complex moral issues surrounding reproductive technologies, thereby facilitating the formation of a general (soft) social consensus around the moral issues associated with IVF (O’Hara 2004).5 While neither the Warnock Committee nor the Report could resolve most of the issues with which they dealt, they served an important function as both public educator and debate-stimulator, moving the debate over embryo research more prominently into the public arena (Poland and Hodgen 1987). Politics: Morally Pregnant Legislative Deliberation The medical and legal issues raised by reproductive technologies, and biotechnologies more generally, received substantial media coverage in the wake of the Report and its subsequent introduction in parliament in late 1984. Indeed, it was not only debated in the House of Commons and House of Lords in the autumn of 1984, but it was ‘debated in churches and women’s organizations around the land’, with key issues being surrogacy and embryo research (Cunningham 1991, 217 and 220). The Report was welcomed by the Medical Research Council (MRC), which, together with the Royal College of Obstetricians and Gynaecologists (RCOG), set up a Voluntary Licensing Authority (VLA) as a temporary measure until a statutory authority could be established (Voluntary Licensing Authority 1986, renamed the Interim Licensing Authority in 1989). The VLA proved an important part of the political landscape, helping to shape public opinion, advocating the need for more research in this area, and attempting to correct some of the misinformation that was being circulated by some of the civil society organizations (Cunningham 1991, 222; VLA 1990). 4 Note that the parliamentary debates contained one proposal, defeated by a single vote, that assisted conception be limited to married couples. The Committee’s position was intended to have a restricting effect, but the more powerful rationingof-treatment factor has (problematically) been the fact that treatment is commonly offered on a pay-per-use basis. 5 Note that the choice to single out one treatment (IVF) within reproductive medicine for such careful consideration and elaborate regulation has not gone uncriticized (Winston 1999, 151).

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All of this reaction and debate gave interested parties opportunities to present to a wide audience their positions not only on the Report but on the technical advancements that had been achieved since the Report (e.g. preimplantation diagnosis). The ongoing debate prompted a series of legislative efforts via Private Members Bills from 1985 to 1987,6 each of which would have made it illegal to create, store or use human embryos for any purpose other than to assist a specified woman to become pregnant, and even then only after a physician applied in writing to the Secretary of State, and the Secretary of State was satisfied as to certain matters. However, all these efforts failed, in no small part due to their failure to deal with controversial matters consistently or, importantly, with certainty (Lee and Morgan 2001, 24). After its initial debate on the Report, the government held a consultation which elicited hundreds of responses from individuals and interested bodies (medical, scientific, social and legal), and which resulted in the preparation of a Green Paper in 1986. In 1987, the government released its White Paper, which was also framed by the Report, and which committed the government to legislative action in keeping with the Report. However, it fleshed out many of the recommendations in the Report and suggested that the new Authority should draft a Code of Practice. The subsequent parliamentary debates (1988-1990) focused on abortion, the boundaries of assisted conception (and particularly the welfare of the child), and the propriety and scope of embryo research. Throughout the debates, it was not uncommon for parliamentarians to proceed from a moral position and advance morality-driven statements. For example, in relation to the abortion aspects of the regime, Theresa Gorman, MP, taking a practical feminist position, stated: … [S]uperficially we are talking about medicine [and] science … For centuries theologians have equated sex with sin and celibacy with grace. They have regarded women as little more than flower pots in which future generations of children, preferably boy children, are reared … I hope that the majority of my [male] colleagues … who do not have to bear the responsibility of unwanted birth and pregnancy … will not have the temerity … to make those decisions for women. (HC Hansard 24 Apr 1990, cols 230–32)

6 E. Powell, MP, introduced the Unborn Children (Protection) Bill in 1985 which was hotly debated but ran out of time. Both K. Hargreaves, MP, and K. Hind, MP, introduced similar Bills addressing embryo research, but they both died in 1985 and 1987 respectively. The Earl of Halsbury introduced the Surrogacy Arrangements (Amendment) Bill in the Lords which was extensively debated but died in 1986, and the Duke of Norfolk re-introduced an Unborn Children (Protection) Bill in the Lords, which died in 1989. In addition, there were significant legislative manoeuvres during this time directed at abortion, a topic which ultimately found its way into the HFEA 1990.


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On the issue of assisted reproduction in general, and adopting a utilitarian and justice-inspired position, Sir Michael McNair Wilson, MP, stated: … [I]n a world that is suffering from overpopulation and … so many incurable illnesses, can the medical profession justify the huge expenditure of vast resources on the more esoteric aspects of medicine, when the money could buy immediate and more easily achievable relief for so many? (HC Hansard 23 Apr. 1990, col. 89)

However, it was on the issue of research, and more particularly, the creation of embryos for research, that the moral debate reached a crescendo. This issue, which turned on judgements about when human life and personhood begins, motivated a broad range of stakeholders into action, including scientists, who, fearing for the future of embryo research, increased their level of engagement (Mulkay 1997, 58), and made common the term ‘pre-embryo’ (a term which has been much criticized (Holland 1990; Mulkay 1997; Silver 1999)) as a means of differentiating the early stages of life. Regarding the pre-embryo and the 14-day cut-off for research, John Hapgood, Archbishop of York, chastised that: … [A] biological approach to life is rooted in gradualism … The same is true in the development of individual lives. They begin with chemistry and they reach their fulfilment in mystery … Biologically speaking we are looking at a continuous process … [I]t is a cumulative process … in which the development of one cell provides the context for the development of its neighbours and its successors. (HL Hansard 7 Dec. 1989, col. 1020)

Lord Rawlinson queried: The question is asked: ‘when does life commence?’ Surely if it has commenced the killing is not acceptable. To those who reply ‘after fourteen days’ I say ‘fourteen days after what?’ (HL Hansard 8 Feb. 1990, col. 953)

And the Earl of Lauderdale lamented: … I believe that this legislation is playing God in the most intimate and sacred centre of life itself. If the embryo were not human then experimentation would have little purpose. Thanks to [this Bill] life may now be created simply for laboratory experimentation … [W]e believe that human debasement has plumbed new depths. (HL Hansard 20 Mar. 1990, col. 247)

Concerns were aired and variously defended by Lord Kennet (HL Hansard 7 Dec. 1989, col. 1026), Lord Robertson (HL Hansard 6 Mar. 1990, col. 1080), and a number of MPs in the House of Commons (HC Hansard 2 Apr. 1990,

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col. 934; HC Hansard 23 Apr. 1990, col. 67), and fears about the emergence of ‘embryo farms’ and the inexorable slide toward genetic engineering of human beings were also raised (Lee and Morgan 2001, 63). In defending embryo research and the creation of embryos for research purposes, Lord Walton adopted a pragmatic and utilitarian position, arguing that reproductive health and safety could only be improved through research on fertilized embryos and that sufficient numbers were not available through IVF treatment (HL Hansard 6 Mar. 1990, col. 1065). The HFEA 1990 was ultimately adopted and came into force in 1991, and it was eventually supplemented by the 2001 Regulations, which extended the purposes for which embryo research could be undertaken, and brought stem cell research into that governance regime. The 2001 Regulations were necessitated by the HFEA’s controversial claim to have licensing authority over human embryonic stem cell research and the use of human embryonic stem cells, a self-initiated jurisdictional expansion that was ultimately confirmed by the judiciary adopting a purposive interpretation of the HFEA 1990 in R (on the application of Quintavalle) v HFEA. The public and parliamentary debates leading up to the adoption of the 2001 Regulations reproduced a morally vibrant exchange, with opinions being expressed about the morality of research activity and the moral content of the UK legislation. The following are examples of morally grounded claims: The 1990 Act endorses the principle in the Warnock Report that a measure of respect should be accorded to embryos, and that research involving embryos should be subject to moral constraints and regulation. That is absolutely right. (HC Hansard 17 Nov. 2000, col. 1180)

And: As a non-scientist, I … do not know whether stem cell research – adult and embryonic – will ever deliver a solution to Parkinson’s. However, we should allow those who have identified potential in that route the chance to realise the ambition of a solution to the disease (HC Hansard 17 Nov 2000, col. 1200).

And: I am driven to my view on the issue not by science, although that is an important factor, but by the ethical duty I believe we as representatives have to do what is right. After careful examination, I have judged that, although it will entail the curtailment of the rights of some early embryos, allowing research into life-saving therapies is the right thing to do. (HC Hansard 17 Nov. 2000, col. 1217)


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Conversely, Ann Winterton MP, stated: As a mother and a grandmother … the fact that we have scientists who think of these [embryos], who are definitely human, simply as a source to be exploited in obtaining cells and tissue, I find frightening. (HC Hansard 17 Nov. 2000, col. 1204)

Of course, the HFEA 1990 served as a framing tool for the debates surrounding the 2001 Regulations. This should not be surprising insofar as the 2001 Regulations are dependent on the HFEA 1990, for which so much moral analysis had already been undertaken, but it is perhaps ironic that, in serving as the discursive frame, the HFEA 1990 has been accused of circumscribing the exploration of issues, consequences and alternatives. It is alleged that it muted the scope, depth, richness, and therefore the quality and effectiveness, of the debate that was undertaken: … [The] rhetorical construction of SCR [stem cell research] in the parliamentary debates slips seamlessly into existing ideas, values and practices, particularly those relating to health, illness and scientific progress. Invocations of the [HFEA 1990] have served to frame SC developments on safe ground by focusing upon embryo research. Broader implications of SCR and cloning-related developments, such as the financial cost of healthcare access to any therapies developed and implications upon sociocultural notions of life, death and nature, were largely muted. (Parry 2003, 165)

And this charge is particularly apropos given the opening statements of the then Under-Secretary of State for Health, which clearly defer to the original debates and express a desire not to repeat them (HC Hansard 17 Nov. 2000, col. 1175). This is an even greater failing if one questions the continued grouping of reproductive treatment and reproductive and other research under a single legislative instrument and regulator (an increasingly prevalent questioning given advances in scientific knowledge and technical capabilities (House of Commons 2006)). Ultimately, although the public and parliamentary debates have been accused of being ill-informed and emotional (Winston 1999, 141), they were reasonably wide-ranging, and, having progressed intermittently over almost a decade, they were reasonably comprehensive. There were numerous sites and opportunities to express opinions, offer evidence, and capture imaginations, numerous junctions at which the protagonists could have turned back or fashioned a very different regime. But the (public) vision that emerged from this process was one of science promotion and permissiveness.

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Law: Birth of a Morally Informed Legislative Regime With the adoption of the HFEA 1990 (and later the 2001 Regulations), reproductive medicine became one of the few areas of medical treatment that is statutorily controlled and intricately regulated (licensed and monitored). The governance scheme established for reproductive treatment and research (and stem cell research) metamorphosized somewhat from that which the Warnock Committee elaborated, but remained very much a Warnock instrument, having been described as a ‘Warnock Act’ (i.e. an Act in which the Warnock Report was not only the benchmark but also the workbench (Lee and Morgan 2001, 23)). The HFEA 1990’s administrative provisions are, by definition, instrumental, combining to address institutional independence, transparency of decisionmaking and the rule of law. Schedule 1 makes clear that the administering authority, the Human Fertilisation and Embryology Authority (HFEA), is a statutory body separate from the Crown, and ss 5-8 and 25 stipulate that it must: • keep under review information about embryos, embryo development, IVF and related treatment, and inform/advise the Secretary of State on such information; • inform/advise licensees about the purposes of HFEA 1990-governed activities; • inform/advise patients and the public about the HFEA and licensed services; • provide both an annual statement of accounts and an annual report of activities; and • maintain a Code of Practice offering guidance concerning the ethical conduct of licensed activities. The HFEA is authorized to grant, vary, suspend and revoke licences to treat infertility and to conduct embryo research (ss 3, 4 and 9–12). With respect to research licences, the HFEA 1990 stipulates that the application must be accompanied by the appropriate fee, the designated facilities must be suitable (and can be inspected pre-issuance), the applicant must be the project supervisor (or some other satisfactory person), the research must comply with licence conditions, and must be undertaken at the licensed premises (ss 9, 10, 13–17). HFEA representatives can enter and inspect licensed facilities and take possession of anything, including recorded information, which they have reasonable grounds to believe may be required for carrying out the HFEA’s responsibilities (s. 39). Where evidence of an offence is provided under oath (by an HFEA representative), the judiciary can issue a warrant permitting HFEA representatives and constables to enter and search premises and


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seize and preserve material (s. 40). With respect to offences, the HFEA 1990 identifies both summary and indictable offences (s. 41), and it imposes civil liability with respect to certain defined wrongful acts (s. 44). The sources for research material (deriving from embryos), and the purposes to which they can be put, are intimately connected to the question of when human life begins. The evidence put to the Committee addressed this question diversely, suggesting that no consensus would ever be achieved. As such, the Warnock Committee refrained from making a determination: Although the questions of when life or personhood begin appear to be questions of fact susceptible to straightforward answers, we hold that the answers to such questions … are complex amalgams of factual and moral judgments. Instead of trying to answer [them] directly we have therefore gone straight to the question of how it is right to treat the human embryo. (Warnock 1985, 60)

Given the need for clarity and enforceability, however, the Warnock Committee, after recording the differing views, recommended that no research should be undertaken on an embryo more than 14 days post-fertilization (around which time the ‘primitive streak’ appears and the embryo takes on a certain level of individuality and capacity to experience sensation). Consequently, Schedule 2 of the HFEA 1990 authorizes (1) the storage and use of embryos for research, which de facto permits the use of supernumerary embryos from IVF treatment for embryonic stem cell research, and (2) the creation of embryos in vitro specifically for research, but forbids any conduct with respect to them after this 14-day period. Although not explicitly stated, it also permits the use of somatic cell nuclear transfer (SCNT) to create embryos for research, and by the end of 2005 the HFEA had issued two licences relating to SCNT and two relating to parthenogenesis. In an attempt to recognize the moral value which (some) people attach to them, embryos are only to be used where they are absolutely necessary, conditions on their use may be stipulated, and licences are limited to a maximum duration of three years. Further, researchers must identify the purpose of their proposed research and the HFEA may only issue licences for research the purposes of which are to: • • • •

promote advances in the treatment of infertility; increase knowledge about the causes of miscarriages; develop more effective techniques of contraception; increase knowledge about congenital, genetic and chromosomal disease; • develop methods for detecting congenital, genetic or chromosomal abnormalities;

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• increase knowledge about the embryo development or serious disease; and • enable knowledge to be applied in developing treatments for serious disease. Prevailing public sentiment and the Human Reproductive Cloning Act 2001, which prohibits the implantation of a cloned embryo in a woman, makes the advancement of reproductive cloning an unlicensable purpose. Given that the procurement of human embryonic stem cells is usually linked with fertility treatment, human embryonic stem cell research is reliant on vulnerable individuals who are under severe emotional, social, marital and financial strains. In recognition of this, special attention was paid to participant safeguards, the HFEA 1990 offering a detailed management scheme of participant interaction with the research environment, clearly disclosing concerns for individual safety and scientific integrity. The primary component of the HFEA 1990’s scheme in this regard is consent, although some reference to privacy is also made – s. 31 of the HFEA 1990 states that the HFEA is obliged to maintain a register of information relating to treatment services and the storage and use of embryos (and gametes) from identifiable individuals, and that information on the register must be kept confidential, particularly with respect to the identity of those who donate, although certain classes of people can apply for access to certain of the information. With respect to consent, under Schedule 3, individuals who store tissue which is ultimately used for research, or who donate tissue specifically for research, must be given the opportunity to receive oral counselling regarding the medical, scientific, legal and psychological implications of their actions before consent can be given. During this period, they must receive written material and be encouraged to seek further information. In addition, the HFEA Code of Practice stipulates that they must be given (1) assurances that neither donation nor research will compromise treatment, (2) confirmation that they are not obliged to donate (for research), and (3) details about research funding and benefits to researchers or related staff. If tissue is to be used in secondary research or genetic research, further information is provided. Having received (all of) this information, donors who give their consent for storage/research must do so in writing, which written consent must address, inter alia, the maximum period of storage and limitations on use. Donors are entitled to vary or withdraw their consent at any time before the embryo is actually used in research. No money or other benefit shall be given or received in respect of the supply of embryos unless authorized by an HFEA Direction (which is considered a licence condition). Even then, payments must not be offered at such a level as to constitute an inducement which might prompt participants to take risks they wouldn’t otherwise take or to volunteer more frequently than is advisable or against their better judgement.


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From a substantive point of view, the HFEA 1990 was intended to be strong, risk-conscious and pragmatic, and it has proved both durable and flexible, characteristics which have contributed to its (and society’s) absorption of new technologies and processes as they have emerged. Ultimately, it has been described as a clear framework which attempts to balance the conflicting interests of childless couples with those of ‘artificially’ produced children, and those of disease sufferers with the human embryo (Lee and Morgan 2001, 49), though it should be noted that, despite this success and clarity, it is still contested. The Moral (Again) – from Substance to Process: The Articulation of Moral Values and Classification of Governance Tools Moral Foundations: Reifying Moral Values in Substantive Provisions The idea that legal rules ought to be explicitly morally/ethically grounded is not without controversy, and there is no simple formula for determining which practices which seem morally right/wrong should be made lawful/unlawful. Having said that, some guidance can be gleaned from Mill, for whom any conduct that involved harm to another was properly amenable to public regulation despite having a clearly moral element. Similarly, despite their disagreement on other matters, Devlin, Hart and Dworkin (Hart 1963; Devlin 1968; Dworkin 1977) agreed that conduct involving an identifiable harm to society was properly a subject for public regulation. In short, there is support for the formulation of ‘biolaw’, which, by necessity, concerns matters having a strong moral element, and the HFEA 1990 is certainly biolaw of the highest order; indeed it is one of the earliest examples of modern biolaw. Its moral foundation/content and the efficacy with which it protects and promotes moral values are important because the HFEA 1990 operates in a world where it is expected to deal with issues such as surrogacy situations and homosexual families, reproductive tourism, fantastic genetic advances from sex selection to reproductive cloning, and virginal, post-menopausal and posthumous pregnancies (note R v. HFEA ex parte Blood, [1997] 2 All ER 687 (CA)), all of which are morally charged and controversial. But what values are deployed and reified through its substantive provisions? Values are here defined as deeply held, high level morally-founded ideas or concepts about what is good and right and supportive of human wellbeing or flourishing, whether individual or social; although often complex, overlapping and opaque, and therefore frequently unarticulated or hidden, they are widely shared (Waldron 1989; Bruce and Tait 2003; Raz 2004; Harmon 2005; Harmon 2006). Although a variety of principles are propounded in its provisions, the primary high level values disclosed are autonomy and solidarity, two concepts which coalesce and overlap with those of respect for human dignity, compliance with procedural fairness, and enforcement of decisional transparency, together

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forming a sometimes inconsistent hodgepodge through which an attempt has been made to satisfy interests (of patients, children, physicians, researchers, the public and future generations) that are clearly, and sometimes wildly, conflicting. As should be obvious from the legal review above, the HFEA 1990 discloses a strong preference for individual autonomy – the enhancement and enablement of personal rule by the individual (e.g. woman and researcher). The research provisions empower women to seek treatment or support research according to their own judgements, and many of the enumerated research purposes are directed at relieving (individual) infertility and improving individual and infant health. Indeed, the rise of reproductive decisional autonomy is exemplified by McFarlane v. Tayside Health Board [1999] 4 All ER 961 (HL), where the court makes reference to the parents’ right to make decisions about how to proceed when their family planning objectives are thwarted by infertility. On the other side of this relationship, researchers are empowered to shape their research, thereby exercise control over the pursuit of knowledge pertaining to contraception, miscarriage, congenital disease, and disease treatment. The participant safeguard provisions disclose a similarly rich vein of interest in offering measures to shelter the participant from the controlling influences of others, and from limitations that prevent meaningful choice. Evans v. Amicus Healthcare Ltd [2004] 3 All ER 1025 (CA), is useful for highlighting the dominance which autonomy-facilitating consent has achieved in this setting. In that case, the court relied on consent rather than a more contextual and socially sensitive basis which gave heed to the moral considerations implicated by the treatment. These provisions also offer some peace of mind that, having chosen to participate, one’s personal choices and information will remain confidential. Solidarity is also implicated in the HFEA 1990, though much less so. This value recognizes the interconnection and mutual reliance of all people, and espouses positive action for the wellbeing of others and for the production of a more just society for all. The stated research objectives of promoting women’s and children’s health, and of relieving human suffering through the reduction of painful, debilitating and humiliating symptoms, clearly implicate solidarity, a value tangled up with human dignity, particularly as that latter value demands contextual assessments of reality and empowers people to act. In short, the encouragement and facilitation of research directed at social wellbeing exemplifies this value. The lesser values of institutional independence and transparency of decision-making are furthered insofar as the HFEA is empowered by democratically adopted instrument, and its powers, processes and criteria for decisions are explicitly enumerated. A concern for, and pursuit of, the rule of law, is also exposed insofar as compliance by stakeholders is monitored and non-compliance with statutory limits or licence provisions is punished and detailed procedures for appeals are provided.


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As suggested above, none of these values is well articulated at the conceptual level, but, in many ways, that is merely an expected reflection of its pluralistic gestation and the hurly-burly nature of its formative processes. Indeed, it demonstrates, once again, that the law ‘is not so much the handmaiden of philosophy as the servant of public policy’ (Morgan 2001, 108) which has many masters advancing a plethora of positions influenced by unconsciouslyheld ideals, and motivated by a variety of interests, some of them selfish and/ or poorly reasoned. Although no underlying philosophy is identified, one might argue that the values exposed and the means of their realization are supportive of a conception of justice informed by an evolution of philosophers. From Aristotle, it draws on the idea of freedom limited only by proportionality (i.e. fairness in relation to others, those others here being limited to those living). Aquinas reiterates this relational element of justice, and adds that it must be capable of reproduction over time (hence the role of law, and, in the present case, the administrative provisions). Kant also acknowledges the role of law in defining standards of fairness which, though culturally, historically and geographically coloured, are based on rationality (the rationality here having been investigated and offered by Warnock, who undertook a Rawlsian exercise of seeking moral judgements from people, reflecting on them, and espousing a fair framework). From Mill and Kelsen it draws on the idea that no value can be absolute (and the regime therefore places limits on the right of action of researchers and women). And in pulling these ideas into a single regime, the HFEA 1990 served to make medical science more democratically accountable (Montgomery 1991). Ultimately, as noted by Warnock, the HFEA 1990 was bound to operate in a realm of diverse moral judgement. As such, the most just/fair approach is one that allows maximum space for individuals to conduct themselves in ways they feel are most moral without infringing others, but at the same time (and contradictorily) which places some (few) limits, and strong oversight, on those actions, again in recognition of the plurality which prevails, and of the damage to early life (which we are trying to understand better). In the result, the HFEA 1990 promotes public accountability, stringent medical standards, and stakeholder consensus within an overarching value of individuality-driven justice, a concept that we as a society have (largely) internalized and pursued in a variety of diverse settings, from the medical, to the commercial, to the corporate, and more. One might charge that a statutory regime grounded in (a theory of) justice and informed by the values of autonomy and, to a much lesser extent, solidarity, is not particularly novel, and it is true that these values can be found in any number of legislative schemes in the UK and beyond. What sets their deployment in the HFEA 1990 apart is the explicitly moral and (arguably) painstaking consideration which preceded that deployment; a consideration which allowed the polity to interrogate their propriety and significance in a new scientific-medical setting which was (and continues to be) quickly evolving. Of

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course, it was not pure rationality which drove the process or which shaped the resultant instrument, it was shifting currents of political influence which saw science emerge as a cultural and moral authority, with the result that the HFEA 1990 has been criticized as contradictory and conceptually shallow (Brazier 1999). Moral Foundations? Locating the HFEA on the Government-Governance Continuum With a lively and sometimes painful gestation of almost a decade, the process which led to the HFEA 1990 has been praised as a successful response by both parliament and government to a new situation; a success achieved by a combination of traditional policy-making instruments and a careful adaptation of parliamentary procedures (Cunningham 1991, 227), this latter reference being to the introduction of a system of ‘pendulum voting’ for the thorny issue of abortion time limits. But how does the process of its creation fare from a governance perspective, and how does the subsequent conduct of the HFEA additionally fare? Recall that governance is a process by which the interests of the state in security, integrity and socio-cultural continuity are balanced with those of individuals in liberty and publicly-supported spaces for self-actualization, this balance being achieved through interactivity (Fox, Ward and O’Rourke 2006). A field (or activity) characterized by a governance model will usually exhibit, to a greater or lesser degree, elements and/or mechanisms that are (Fox, Ward and O’Rourke 2006; Shore and Wright 1997; Milne and Tait this volume, Chapter 5): • proactive (precautionary but forward-looking) rather than reactive (adverse impact and cumulative); • inclusive (consultative and participatory) rather than exclusive (closed and centrally steered); • enabling (space-creating and incentivist) rather than constraining (negative and purely evidence-driven); and • discriminating (directed at achieving a specified outcome) rather than indiscriminate (overbroad eligibility for inclusion and therefore of variable effectiveness). Moreover, a governance approach relies on the coordination of multiple actors to achieve policy goals such that the state no longer dominates the process, and decisions are made by problem-solving rather than bargaining. In this respect it has been said that the policy-making process is restructured as a collaborative melding of three perspectives: (1) the subject community (in this case scientists, related commercial entities and directly involved patients); (2) public policy-makers (regulators and governmental representatives); and (3)


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publics (advocacy groups representing patients, faiths and values, commercial and scientific interests, etc.) (IRB 2006). Having reference to the above criteria, the process leading to the adoption of the HFEA 1990 was very much risk-driven and reactive, being a response to the birth of Louise Brown and the perceived need for moral restraints on assisted reproduction and research, and the promulgation process was an exercise in determining to what extent those moral limits (which were never truly settled) should be expressed in legal form. In this respect, it looks more like a government response than a governance activity. However, neither the debate nor the final legal regime were purely instrumental; rather they involved (and continue to involve) participants in moral analysis, horizon-gazing, and the articulation of a broader picture (i.e. what it is to be human), and they demand that reproductive medicine be positioned and defended within that picture. Moreover, that process was widely inclusive, first relying on the Warnock Committee and the evidence it generated, and then involving a long parliamentary phase which implicated a variety of strong, well-organized advocacy groups (Mulkay 1994; Kirejczyk 1999). Indeed Mulkay says: The examination of the rights and wrongs of embryo research in Britain during the 1980s was highly unusual in the degree to which it subjected a particular branch of scientific inquiry to sustained, collective appraisal … The public debate over embryo research led people to assess the morality of scientific research in its approach to such fundamental concerns as birth, death, disability and respect for human individuals [and] … people’s hopes and fears … were publicly formed and displayed. (Mulkay 1997, 2)

Similarly, it certainly implicated the three perspectives identified above. Having said that, one should not overstate the extent to which its long participatory element was consciously directed at genuine problem-solving and rational boundary-setting; a lot of vested interests advanced (very loudly) a lot of parochial claims and so the extent or effectiveness of the ‘collaborative melding’ can be questioned. The final instrument was clearly enabling insofar as it was conscious of the need to create a space where a quickly evolving science could thrive, but it also had (and retains) very strong constraining elements, including the inclusion of criminal sanctions. The final instrument was also certainly discriminating insofar as the consequent instrument relates to a specific activity, addressing a certain category of medicine (e.g. reproductive medicine), and a particular type of research (e.g. that reliant on sourcing of materials from reproductive processes). In the end, the output of the process (e.g. the HFEA 1990) is an example of ordered rule; it constitutes a traditional legal response to a subject considered to be of public importance. And, despite persistent disagreement around certain core issues – such as the point of transition from embryonic material to human individual – the statutory output adopted a rigid distinction, opting

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for a hard point (e.g. day 14) at which that transition occurs. Where many of the elements of its creation are suggestive of a governance process, the ultimate output, and this latter characteristic, might seem to push the whole endeavour more toward a government model. However, as noted by Milne, governance outputs are often no different from those of government, rather it is the process that is different. The process here, though perhaps centrally situated on the continuum, leans more toward the governance pole. With respect to the way the HFEA has acted, and the processes it has adopted, since its inception, one can more clearly see a strong governance hue. As noted above, some of its primary and recurring activities include: • providing information to patients, donors, and donor-conceived people about services, processes and sources of support; • providing information to the public about the HFEA and its remit and activities; • providing advice to clinics and clinical staff and maintaining and disseminating a Code of Practice; • providing advice to government about its activities and developments in the field of reproductive medicine and research; • acting as a gatekeeper for embryonic and embryonic stem cell-based research through its licensing and monitoring functions; • acting as non-political nexus for the debate of emerging issues in the reproductive medicine and research setting through its consultation functions. Although some of its activities might be considered blunt (e.g. investigating and seizing records), and others might be considered typically top-down (e.g. licensing and licence review), much of the HFEA’s conduct is intended to be complicit rather than compelling (i.e. it facilitates problem-solving amongst stakeholders). Many of its activities are directed at achieving a degree of compliance so that acceptable conduct is regularized amongst actors. Further, its close and frequent interaction with stakeholders has meant that the modification of behaviour has been a multi-directional process – a claim arguably evidenced by the HFEA’s adding of embryonic stem cell research to its bailiwick, and by its willingness to take a lead on human-animal hybrids. This interactive feature of the HFEA’s conduct is akin to a deliberative democracy approach to science regulation insofar as it tries to: (1) engage with a broad spectrum of society and thereby take into account the widest range of evidence possible; and (2) rationalize conflicting interests and strive to economize or minimize moral disagreement, thereby decreasing the possibility of outright rejection of activities based on incompatible values. Of course, antagonism and entrenched reliance on incompatible values cannot be utterly eradicated, but the HFEA’s attempt to promote understanding and solicit direction constitutes a deliberative effort within the confines of its statutory


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parameters. And this process, seeded by the Warnock process and watered by the long parliamentary process, feeds into and enhances the theory of justice that is evident from its substantive (value) content. In the end, although the HFEA 1990 (and 2001 Regulations) are command and control instruments, they demand that stakeholders operating in a fluid area participate in a dynamic and ongoing balancing exercise whereby researchers must address, and the HFEA must decide, whether research has the potential to lead to significant health benefits for others, and whether the use of embryos is necessary to realize those benefits. This balancing is forever being recast or reinvented as new technologies and processes come before the HFEA that were not envisioned when the regime was drafted (e.g. stem cell research, hybrid research), and the manner by which this recasting is achieved suggests that the HFEA’s processes are an example of governance in action. Conclusion: Through the Governance and the Morality Lenses This chapter has offered a brief case study of the processes leading up to, and the content of, the HFEA 1990. The dual purpose of this case study has been to consider the HFEA 1990 through a values lens and a governance lens. With respect to the former, I have highlighted the concerns that drove its formulation, the values relied on in its deliberation, and the values ultimately deployed with its promulgation. With respect to the latter, I have highlighted the processes which preceded its adoption and interpreted them from the governance perspective. From this bifocal analysis, several conclusions can be drawn. First, although it is doubtful that the HFEA 1990 can be described as the product of a moral majority – the very existence of which has been questioned in the modern, plural context (Plauché 2006) – it is nonetheless moral legislation, or perhaps more accurately, a good example of legitimate, morally alive legislation. Morality was explicitly and extensively considered in its formulation, and a vision of morality reflective of the primary concerns of many stakeholders (advancing a theory of justice largely resonant within the target polity) was reified. Second, the dominant values evident in the statutory regime (e.g. autonomy, solidarity, human dignity, democracy) have been deployed such that the concerns aired before the Warnock Committee, and in parliament thereafter, can be addressed in a principled manner on an ongoing basis. Sir Liam Donaldson, Chief Medical Officer, has stated that one of the UK’s ‘trump cards’ has been ‘a very good system of regulation in place, set out initially by a very wise bird, Mary Warnock, who … looked at the whole thing very, very carefully’. Similarly, both Colin Blakemore, former Chief Executive of the Medical Research Council, and Hugh Whittall, Director of the Nuffield Council on Bioethics, have indicated that the framework remains an appropriate model (House of Commons 2006).

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Third, despite some strong bargaining features, the process that led to the HFEA 1990 constitutes a deliberative democratic exercise closer to the governance pole than the government pole. Although it resulted in a hard legal instrument which preserves the position of the state at the hierarchical summit, both its formulative and its subsequent operative processes reflect many of the elements of a governance model; a problem-oriented, interactive policymaking and policy-management system. Thus, perhaps without intending to be so, the HFEA 1990 represents an early example of governance in action. In this respect, one can argue that broad values of justice and democracy were exercised or furthered through its creation. Postscript: The HFEA 1990 and the Future Although the HFEA 1990 has weathered changing (or sharpening) moral concerns as reproductive and stem cell technologies bring us closer to the capabilities that so scared so many, it must be recalled that: Human fertilisation and embryology are an area of rapid change and continuous advances … When we came to debate the Bill there were many new issues … which were not considered by the Warnock Committee because they had not even been thought of just those few years before. It is wrong to suggest that in passing a law … that says that in principle research should be allowed … [this] somehow marks the end of the debate. The matter will remain one of public interest and also of controversy. (Harman 1990, col. 49)

More recently, it has been claimed that: The Act has stood the test of time well, and is a tribute to the foresight of its creators … . The Act and the regulatory system it established have instilled public confidence in the safe and ethical use of assisted reproduction technology subject to appropriate safeguards. However, it was never expected that the Act would remain forever unchanged in this area of fast-moving science. (DOH 2005)

As such, the HFEA 1990 should probably be viewed as a ‘temporary statement on the morality of the issues under examination’ (Lee and Morgan 2001, 23), and we should be cautious about relying on it too long or too uncritically. In fact, allegations now abound that: • the potential for ongoing and broader-ranging critical assessment of the ethics of treatment and research in the reproductive setting has been stifled by the HFEA 1990;


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• the continued propriety of fusing reproductive treatment and stem cell research into a single regime is questionable; and • the discovery of new knowledge and practices, together with the obvious overlap between the HFEA 1990 and the Human Tissue Act 2004 makes the existing framework inappropriate to the modern setting. Given these allegations, a wholesale reconsideration and restructure of the regime might have been warranted. However, the HFEA 1990 has become a ‘constitutive element’ of the environment with ‘strong architectural features’ (Lee and Morgan 2001, 25). In short, it shapes the advance of the science, provides a framework for considering those advances, but tempers the shaping possibilities through structures that influence society’s response to science and conceptions about itself and individual relations. As such, certain stakeholders (and parliament) seem unable to imagine an alternate regime with the result that the reform deliberations of early 2008 degenerated into an exercise of minor refitting before being shelved altogether. References Beck, U. (1992), Risk Society: Toward A New Modernity (London: Sage). Benatar, S. (1999), ‘A Perspective from Africa on Human Rights and Genetic Engineering’, in Burley, J. (ed.) The Genetic Revolution and Human Rights (Oxford: Oxford University Press). Brazier, M. (1998), ‘Reproductive Rights: Feminism or Patriarchy?’, in Harris, J. and Holm, S. (eds) The Future of Human Reproduction (Oxford: Oxford University Press). Brazier, M. (1999), ‘Regulating the Reproduction Business?’, Medical Law Review 7, 166–93. Brazier, M. (2006), ‘Evidence to the Joint Committee on the Draft Human Tissue and Embryos Bill’, HTEV 109, available at . Bruce, A. and Tait, J. (2003), ‘Interests, Values and Biotechnological Risk’, in Andersson, K. (ed.) Values in Decisions on Risk Proceedings (VALDOR) Symposium Proceedings (Stockholm), 109–18. Cunningham, R. (1991), ‘Legislating on Human Fertilization and Embryology in the United Kingdom’, Statute Law Review 12, 214–27. Department of Health (2005), Review of the Human Fertilisation and Embryology Act: A Public Consultation, available at , accessed 5 November 2008. Devlin, P. (1968), The Enforcement of Morals (New York: Oxford University Press). Dworkin, R. (1977), Taking Rights Seriously (London: Duckworth).

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Dworkin, R. (1993), Life’s Dominion (London: HarperCollins). Edelmann, R. and Golombok, S. (1989), ‘Stress and Reproductive Failure’, Journal of Reproductive and Infant Psychology 7, 79–86. Fox, N., Ward., K. and O’Rourke, A. (2006), ‘A Sociology of Technology Governance for the Information Age: The Case of Pharmaceuticals, Consumer Advertising and the Internet’, Sociology 40:2, 315–34. Habermas, J. (1996), Between Facts and Norms (Boston: MIT Press). Harman, H., MP (1990), Official Report, Standing Committee B, col. 49, 8 May. Harmon, S. (2005), ‘Regulation of Human Genomics and Genetic Biotechnology: Risks, Values and Analytical Criteria’, noGen WP-40, available at , accessed 5 November 2008. Harmon, S. (2006), ‘Solidarity: A (New) Ethic for Global Health Policy’, Health Care Analysis 14, 215–36. Harris, J. (1998), ‘Rights and Reproductive Choice’, in Harris, J. and Holm, S. (eds) The Future of Human Reproduction (Oxford: Oxford University Press). Hart, H. (1963), Law, Liberty and Morality (Stanford: Stanford University Press). Holland, A. (1990), ‘A Fortnight of My Life is Missing: A Discussion of the Status of the Pre-Embryo’, Journal of Applied Philosophy 7, 25–37. House of Commons Joint Committee on the Human Tissue and Embryos (Draft) Bill (2006), First Report of the House of Commons Joint Committee on the Human Tissue and Embryos (Draft) Bill, available at , accessed 5 November 2008. House of Commons Select Committee on Science and Technology (2004), Fifth Report of the House of Commons Select Committee on Science and Technology, available at , accessed 5 November 2008. Innogen Retreat Brief (2006), 8 November. Jonas, H. (1984), The Imperative of Responsibility (Chicago: University of Chicago Press). Kirejczyk, M. (1999), ‘Parliamentary Cultures and Human Embryos: The Dutch and British Debates Compared’, Social Studies of Science 29, 889–912. Knowles, L. (2004), ‘A Regulatory Patchwork – Human ES Cell Research Oversight’, Nature Biotechnology 22, 157–63. Knowles, L. (2005), ‘Stem Cell Policy: Where do We Draw the Lines?’, New England Law Review 39, 623–34. Latham, M. and Leonard, S. (2001), ‘The European Convention on Biomedicine and the Human Rights Act 1998: Grasping the Nettle of Biomedicine?’, in Garwood-Gowers, A., Tingle, J. and Lewis, T. (eds) Healthcare Law: The Impact of the Human Rights Act 1998 (London: Cavendish).


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PART 2 Processes


Chapter 5

Evolution along the GovernmentGovernance Continuum: Impacts of Regulation on Medicines Innovation in the United States Christopher-Paul Milne and Joyce Tait

Introduction In recent decades a body of work in the social sciences has studied the way regulations work in the field of science, technology and innovation (STI). It has detected changes in the interaction of regulators with the regulated in terms of a movement away from top-down, command-and control ‘government’ towards a new bottom-up ‘governance’ approach that focuses on problemsolving rather than regulatory bargaining. The emergence of the governance approach is most apparent in agriculture, the environment, transportation and the life sciences, because of the rapid and increasing uptake of STI in these industrial sectors. Among the main drivers of the need for new policy approaches are globalization and the resulting rapidity of technological change (Tait et al. 2006, 379). Other influences include: the rise of consumer, patient, and ‘grass roots’ advocacy groups; the development of an expansive and affordable information technology network allowing worldwide and instantaneous information dissemination and retrieval; the power of the media to keep an issue in the public eye; and the incapacity of governments alone to marshal sufficient resources in terms of both staff and expertise to meet the challenges of rapid change brought about by the forces of STI. In response, the emergence of new governance structures and policy processes has been characterized by attempts to set parameters of the system within which people and institutions behave with the assumption that incentives and self-regulation can achieve the desired outcomes (ibid.). However, as a developing sector becomes more mature, it generally loses the capacity for self-regulation. As self-regulation has declined as a governance option, incentives have burgeoned. Initially, these took the form of science push and market pull (Spinardi and Williams 2005, 48, quoting Freeman 1974). Later, it was believed that efficiency could be achieved by ‘coupling’

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of innovations and user requirements. This became problematic as studies began to show that new advances in science and technology often did not find immediate application, and had outcomes that were far removed from initial promises, and even sometimes undesired consequences (Spinardi and Williams 2005, 48). In fact, there was growing recognition that understanding the interdependence between public policy and company business strategy, and the integration of STI promotion policies with the regulation of impacts from life science technology, were neglected areas (Chataway et al. 2006). This neglect is especially precarious in the life sciences because, at the same time as there is a need to foster innovation, there is a need to maintain a greater degree of top-down, regulation-based government intervention to control risk (see Preface to this book). In particular, the scientific complexity, the enormity of private and public funds invested, and heightened public sensitivity toward new healthcare technologies have proscribed movement towards industry self-regulation. Yet, overly onerous or intrusive regulatory intervention can act as an insurmountable barrier to full entry into the sector for the small and medium-sized business enterprises (SMEs), which are the seedbeds of innovation. For example, of the nearly 2,000 active biotech medicines in preclinical development, only 15 per cent are ‘owned’ by the top 20 pharmaceutical firms, yet big pharma owns nearly 40 per cent of projects in late development, and over 70 per cent of the biotech medicines that have actually reached the market over the last 20 years (Lewis and Fearn 2006). The higher the bar for SMEs, the greater the assurance multi-national companies have that their market strategies will maintain their dominance of these sectors, thus driving the innovation trajectories of life sciences as a whole (Tait 2007). This pitfall further imperils an already precarious path. On the one side, advances in the basic biomedical sciences are predicted to have enormous impact on the prevention, diagnosis, treatment and cure of disease and disability. The long list of promising technologies and fields includes (but is not limited to): pharmacogenomics, proteomics, nanotechnologies, microarrays, biomarkers, bio-informatics, synthetic biology, as well as cell and tissue engineering. On the other side, because the R&D process has become increasingly costly, unpredictable and inefficient, these advances cannot optimally deliver improved health products and processes to patients. In other words, the explosion of promising new fields of research and technological opportunities will not automatically translate into broad based improvements in health care (OECD 2006). In order for regulatory systems to effectively manage STI in research and development (R&D) areas with significant public health and investment risks they must evolve toward a new governance approach that provides greater government interaction not only in terms of providing incentives, the traditional province of governance, but also of intervention, although not in the old ‘government’ style (Tait et al. 2008). While it is true that, as governance creates conditions for ordered rule, its outputs are no different from those

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of government, what are significant are the differences in processes (Lyall et al. this volume, quoting Stoker 1998, 2). The role of the state changes from being the main provider of policy to one of facilitating interaction among various interests by problem-solving rather than bargaining (Lyall et al. this volume, p. 4). While this approach has sometimes been decried by the Food and Drug Administration (FDA) regulators as ‘hand-holding’ along with complaints that the agency is ‘meetinged out’, they have also recognized that in the absence of sufficient interaction throughout the process, the outcome can be insufficient product dossiers, resulting in costly development failures for product sponsors or resource-intensive multi-cycle reviews of product applications for regulators. Governance attempts to temper the process of policy-making from coercion to collaboration by melding elements of three perspectives (see Foreword to this volume): • innovation communities – natural, environmental and medical scientists, those translating science through to application in public and private markets, and the public and commercial organizations through which the translation takes place; • policy makers and government – actors involved in the promotion and regulation of science and innovation and in responding to public interests and concerns; • publics and stakeholder groups – commercial lobby organizations, patient groups involved in lobbying or advising the developers of new genomic technology, and advocacy groups with more general valuebased positions on new life science technology. There is naturally tension among the various interests. One solution to easing these tensions has been the use of policy networks. Policy networks are defined by the nature of their participation and relationship to the government in which the policy targets (i.e. the regulated and stakeholder community) actively embody the process, such as with a task force (Lyall 2007), or as with the regulatory programmes described in this chapter, formal advisory functions in the regulatory process itself. The premise of this chapter is that the FDA has two programmes, the orphan product and fast track programmes for biopharmaceuticals, which serve as useful models of a regulatory system evolving towards a governance approach in the field of STI. These programmes facilitate innovative R&D of products for critical unmet medical needs in areas with both high entry barriers and high public health risks. These programmes evince certain characteristics associated with governance such as push-pull incentives and a problem-solving philosophy, but also demonstrate features of old-style command-and-control government. Paradoxically, although more rather than less, intervention from the top down is brought to bear, it is of a complicit rather than compelling

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nature, facilitating problem solving between policy targets and policy makers. Hence there is more control, but less command. The chapter examines several overarching questions that are critical to the consideration of how effective these programmes may be at furthering the governance agenda for regulating STI: for example, whether the programmes actually work; whether they meet the goals of the governance agenda; and whether they have broader applicability outside of their current context. In conclusion, we will add some final thoughts and perspectives on the role governance tools can play to help repair some of the disconnect in today’s regulatory environment. Regulatory Background This analysis focuses on the regulation of biopharmaceutical R&D in the United States. Although the US contains only 4 per cent of the world’s population, it accounts for over 50 per cent of the world’s healthcare market (Castel 2005), close to 50 per cent of the global prescription drug market (Truelove 2007), and contributes over 50 per cent of the new medicines launched worldwide each year (Milne 2008). The US has had a central framework for the regulation of medicines for over 100 years under the auspices of the FDA within the US Department of Health and Human Services, which has maintained a relatively consistent process for review and approval of new medicines over the last 40 years. US Orphan Products Programme The early history of the initiative to develop an incentive programme for R&D of rare diseases arose, in part, from civil defence concerns prevalent in the US during the early Cold War era of the 1950s and 1960s. In 1964, a Public Health Service (PHS) Task Force was convened to determine if the needs of the PHS hospitals were being met, regarding their capacity to treat rare and tropical diseases. In the 1970s, as the civil defence urgency waned, the age of advocacy began to blossom with the emergence of patient groups for, among other things, rare diseases. These patient groups were later organized under the umbrella of the National Organization for Rare Disorders (NORD). The focus of concern shifted away from protecting the US against microbial invaders, towards providing drugs for indigenous rare diseases. The government contribution to this initiative was called the Interagency Committee on Drugs of Limited Commercial Value, which was convened by the FDA’s Bureau of Drugs. The committee identified several problem areas of drug development with high therapeutic need but low economic value, including therapeutic agents to treat diseases affecting small numbers of patients, so-called ‘rare disorders’ (Milne et al. 2001). Ultimately, the result was the passage of the Orphan Drug Act of 1983 (commonly referred to as the ODA and actually passed in December


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1982), which amended the primary US statutes controlling the regulation of drug and biological products – the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. The term ‘orphan drug’ reflected the fact that no company would be interested in commercializing medicines for such small patient populations, due to the inability of the firm to achieve a reasonable return on investment. The current eligibility requirements for orphan drug designation are that a drug must affect less than 200,000 people in the US, or if it affects more than 200,000 people, that there is no reasonable expectation that the costs of development and production will be recovered by sales (Office of Orphan Product Development 2007). The orphan products programme provides a number of push-pull incentives (variations of the carrot incentives used in a ‘rowing’ approach to governance1) for sponsors of products to treat rare diseases. The push incentives lower the logistical and financial barriers for entry into this field of R&D, while pull incentives increase the likelihood that if the products reach the market, there will be sufficient return on investment. The first (push) incentive is technical and administrative assistance with the identification and development of orphan products provided directly by the FDA’s Office of Orphan Products Development (OOPD), which consists of a staff of approximately 25 scientists and administrators. Specific protocol assistance concerning what studies the sponsor needs to complete in order to obtain regulatory approval is available from the FDA reviewing divisions. The OOPD monitors the review process and assists in resolving specific issues that may arise. The second (push) incentive is the availability of FDA grants to cover clinical trial expenses. Grants for total costs (direct and indirect) are limited to $200,000 per year for smaller Phase I, II or III studies, and up to $400,000 per year for Phase II or III studies (ibid.). The third (push) incentive is that user fees, such as registration fees paid to the FDA by a sponsor for review of a marketing application ($1,178,000), are automatically waived. The FDA Amendments Act of 2007, known as FDAAA (Public Law 110-85, enacted 27 September 2007), has recently expanded the waiver to include product ($65,030) and establishment fees ($392,700). The fourth (push) incentive is the availability of tax credits, which can be subtracted from the company’s tax payment. These credits can be for as much as 50 per cent of clinical development costs. The tax credits can be carried forward for 15 years or backward for three years. The fifth (pull) incentive, so-called orphan exclusivity, prohibits FDA from approving a marketing application for the same drug that treats the same condition or illness for seven years from the date of approval of the first orphan application, even in the absence of a patent. 1 This refers to the oft used term in the governance literature ‘steering not rowing’ to describe the new role of governments in setting broad policy goals while leaving it to others to deliver.

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US Fast Track Development Programme Fast track designation was designed to facilitate development and approval of drug and biological products intended to treat serious or life-threatening conditions, and which demonstrate the potential to address unmet medical conditions. The fast track programme has been in existence for 10 years. Its origins are more nebulous than those of the Orphan Drug Act. The AIDS and cancer lobbies were factors in the genesis of the progenitor programmes that later shape-shifted into fast track. The first of these was initiated in 1988, still early in the AIDS epidemic when there was a rush to develop the first generation of anti-retrovirals. It was called simply Subpart E after its place in the text of the code of federal regulations. It still exists, but the procedures to expedite development have largely been subsumed into the fast track programme. In 1992, in response to what AIDS advocates considered an unacceptably high regulatory burden for the anti-AIDS drug, AZT, the FDA allowed accelerated approvals based on surrogate endpoints as evidence of effectiveness. In the mid-1990s, FDA also initiated an informal policy allowing for rolling submission of parts of a new drug application before the entire application was submitted. Theoretically, this would allow sponsors to benefit from FDA taking a ‘sneak peak’ at sections of the application and possibly providing the sponsors advance notice of problems. Finally, by the late 1990s, the challenges faced by the biopharmaceutical industry, and its frustration with what it perceived as an increasingly imperious FDA led to calls for ‘privatizing’ FDA. The congressional compromise was the Food and Drug Administration Modernization Act of 1997, called FDAMA (42 USC § 282(j), enacted 21 November 1997), which was a wholesale revamping of the FDA. Among its many provisions was Section 113 that codified and consolidated existing FDA regulations and policies under a comprehensive fast track product development designation. Fast track designation is comprised of four basic programmes: • meetings – the meetings programme focuses on regular, appropriately timed consultations between the agency and the fast track designee, especially at critical junctures during the drug development process; • written correspondence – written correspondence consists not only of the information provided to FDA by the sponsor, but also the timely comments provided by FDA on the design of the principal trials and the adequacy of the sponsor’s Phase II or III development plans; • review programmes – review programmes refer to the opportunity for priority review of the new drug application (NDA) or biologic license application (BLA), a ‘rolling review’ of portions of a marketing application before the full NDA/BLA is submitted, and accelerated approval; and


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• dispute resolution – dispute resolution means that FDA determinations made under the fast track programme may be appealed at a level beyond the reviewing division/office, if need be (FDA 1998). FDAMA also created a public database of information on clinical trials of fast track products conducted under the FDA’s investigational new drug (IND) regulations, which is maintained by the National Institutes of Health (NIH) (i.e. clinicaltrials.gov). The reauthorization of FDAMA as the FDA Amendments Act of 2007 expanded this database and created a new one for clinical trial results. Evidence of ‘What Works’ Both programmes can be described as more collaborative than coercive. Product sponsors voluntarily decide to apply for orphan and/or Fast Track designation. They are basically incentive programmes with eligibility criteria that serve public health goals. The programmes are more concerned with problem-solving than policy bargaining. The impetus for sponsors to seek designation may originate with patient advocacy groups, or even FDA itself. By granting designation, the agency makes a commitment to sponsors that it has a stake in shepherding designated products through the system, although there is no guarantee of approval. In these terms, the programmes are exemplars of governance tools. However, the governance agenda is equally concerned with ‘what works’ (Lyall and Tait 2005, 180). As noted by prior research in this area, obtaining unequivocal evidence for the effectiveness of a policy initiative is difficult to achieve using evidence that does not have exorbitant collection costs and that can be gathered on a timescale that is useful to policy-makers (ibid.). However, without such evidence the governance perspective is in danger of becoming just ‘a simplifying lens to a complex reality’, (Lyall et al. this volume, quoting Stoker 1998, 8). This begs the question whether the requirements for strong government, a good evidence base for policy decisions, and for a greater degree of stakeholder engagement in policy decision-making actually lead only to extreme complexity that cannot be resolved. If this is not the case, are there examples of policy and regulatory instruments that can be tailored to deliver the necessary public governance of innovative technology and its risks, and at the same time foster profitable innovation? For our purposes, the overarching question of whether these programmes work begets several further questions that define the limits of our inquiry. How effective are these programmes as industry incentives? How effective are they at fostering innovation? How well do they involve stakeholders? How well do they address unmet medical needs? How effective are they at controlling risks to the public health?

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Collection of Relevant Materials The current literature on the separate topics of governance in STI, orphan product programmes and fast track is extensive, while the literature on the confluence of all three subjects is all but non-existent. A database search for reference materials containing all four terms was conducted in several relevant bioscience databases (PubMed, Ovid Medline, and Illumina’s Health and Safety Science Abstracts). Only references to newspaper articles or materials from the authors’ research centres were found. Thus, the authors relied on the extensive literature generated by their respective research centres, Tufts Center for the Study of Drug Development (Tufts CSDD) and ESRC Innogen Centre, and pertinent contributions by colleagues within and outwith the centres as the primary sources for background materials. The database analyses were conducted on data collected by the Tufts CSDD through a series of confidential surveys of R&D sponsors, including drug companies, biotechnology firms, academic medical centres, non-profit research institutions, and individual biomedical researchers. Data collection is ongoing at Tufts CSDD and the data relied on for these analyses are maintained in four separate databases. The analyses were done utilizing version 9.1 of SAS and Microsoft Office Excel 2003. Data are also derived from the public domain, including the FDA website and three commercial databases to which Tufts CSDD maintains subscriptions (IMS R&D Focus, Thomson Scientific Investigational Drugs Database, IDdb3, and PharmaProjects V. 5). For analysis of quantitative data, orphan products were divided into three five-year periods to provide trends over time with statistically relevant numbers in each cohort, beginning in 1992 when the amended regulations went into effect that established the current regime for orphan products. Fast track products were divided into two cohorts (1998–2003, 2004–2006) based on an approximate even split of total approvals between these time periods, again to provide some perspective on changes over time while maintaining statistically relevant numbers in each cohort. Qualitative data in the form of the perceptions and opinions of policy targets (i.e. private and public sector researchers) and policy makers (i.e. FDA), were drawn from the literature as well as surveys conducted by Tufts CSDD in 2000–2001 of firms receiving fast track designations and orphan grant recipients in 2003 and 2005. Lastly, the authors relied on their own experiences and expertise in selection and presentation of the salient points of the current literature and development of the assessment questions. Orphan Products and Fast Track Programme Impacts Before considering the impacts of these two programmes, it is important to note on the one hand, the programmes have been operational for different periods of time: fast track for one decade since 1998, and the orphan products


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programme for just over two decades since 1984. On the other hand, the two programmes overlap, approximately 40 per cent of fast track designated drugs in development in the early 2000s had orphan designations (Milne 2001), and just over 30 per cent of orphan and fast track products approved during 2004– 2006 actually had both designations (Tufts CSDD 2007, unpublished data). As noted above, both the fast track and orphan programmes are exemplars of governance approaches to promote innovation through science push and market pull. Pull is focused on the revenue side of the profit equation, rather than the cost side, where push is relevant. Push incentives consist of programmes that result in R&D cost sharing or subsidies. Examples of push funding include direct research funding, and tax breaks on R&D expenditures. In contrast, pull mechanisms create incentives for private sector engagement by creating viable market demand. Pull incentives include such devices as guaranteed purchase agreements and market exclusivity provisions (Grabowski 2005; Grace 2006). Incentivize industry The orphan product programme consists of both push and pull incentives that reduce the fixed costs of R&D and regulatory approval, while increasing the expectation of profits, by providing monopoly market conditions (Peabody 1995). In the aggregate these incentives provide an economic rationale that makes the orphan drug market more attractive to drug developers. Indeed, it has worked to do just that. Before the ODA was passed, two or three drugs that might have been eligible as orphans were approved annually (ODA Amendments 1992). Just in the two decades since the ODA was passed, some 1,700 orphan designations have been granted, and approximately 300 orphan drugs approved, about 10 per cent through programmes supported by FDA grants (OOPD website 2007). The rate of industry participation continues to increase. In the first 10 years after the ODA was passed, an average of 8.5 orphan drugs were approved per year, but that rate has nearly doubled in the second decade. Of all the orphan designations awarded from 1992–2006, 26 per cent per cent occurred during the first five years of that period, 31 per cent during the middle period, and 43 per cent during the most recent five years (Tufts CSDD 2007, unpublished data). While some ODA incentives act uniformly across the various segments of the R&D community, others act differentially. For example, the sevenyear orphan product exclusivity serves as an incentive across the spectrum of large and SME orphan product developers, within both the private and public sectors, and is generally considered the most important incentive (Milne et al. 2001). However, tax credits are more valuable to biotech and pharmaceutical firms which have revenues that can be offset (i.e. typically such firms are not start-ups), while waivers of application fees can be important for cash-strapped small companies making the jump from incubator firm to a health care products business. At the same time, orphan grants provide seed funds, which are particularly valuable for orphan product sponsors working

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in the public sector (not coincidentally, as discussed below, US orphan grant recipients are overwhelmingly from the public sector). International uptake of the orphan product approach demonstrates that it meets certain common needs that exist worldwide, but that it is also adaptable to national settings. Japan has had an orphan drug programme since 1993. Orphan drugs have become a mainstay of drug development in Japan, comprising nearly half of all new drugs in development during its first decade. Over 90 per cent of designations are for diseases or conditions with fewer than 10,000 patients, many of special public health concern for Japan, such as leprosy (Shiragami and Nakai 2000). Australia (along with New Zealand) has a robust but still incipient orphan drugs programme with several interesting features such as a focus on poison antidotes and antiinfectives for special conditions, and piggy-backing off the US programme through an interagency agreement for expedited approval of orphan products already approved by the FDA. Singapore’s orphan drug law features expedited importation of orphan products approved by recognized foreign regulatory authorities. Israel and South Korea are considering orphan legislation and Canada has regulatory programmes designed to have some of the benefits of orphan drug laws. The European Union began to implement its version of an orphan product incentive programme in August 2000. It is similar to that of the US but actually incorporates more of a governance approach. It contains several push and pull mechanisms such as eligibility for fee waivers, a Community marketing authorization, a 10-year marketing exclusivity, and protocol assistance (i.e. scientific advice). The programme also established a Committee for Orphan Medicinal Products (COMP) to achieve integration of member states and provide a network of professionals as well as a COMP working group comprised of interested parties from the regulatory agencies, industry and patient groups. It also benefits from the efforts of the Rare Disease Task Force (RDTF) set up by the Commission Services in 2004. The RDTF acts as a forum for discussion among current and past community health project leaders, experts nominated by member states and representatives of relevant international organizations, such as the EMEA, WHO, and OECD (EU website 2007). Regarding the impact of fast track as an industry incentive, the steady increase in industry participation over time is a positive indicator. By the year 2000, just over 100 designations had been granted, and by 2006 this number had increased to nearly 500 (Tufts CSDD 2006). At least three positive impacts from fast track designation are quantifiable: shortening of total development time (time from the date of the investigational new drug application submission to the date of the new drug approval); an FDA interaction effect; and an investment effect.


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A recent government study found that fast track products have shorter median approval times than all other applications assigned Priority Review2 (Thaul 2008), a finding that was recently confirmed by a Tufts CSDD analysis (DiMasi and Faden forthcoming). However, clinical development times were within the historical range for comparable newly approved drugs and biologicals (Tufts CSDD 2006; Reichert et al. 2009). An econometric analysis of fast track suggests that shortening the arduous path from lab bench to pharmacy shelf can have the following effects: 1) earlier access to cash returns; 2) cuts in development costs; 3) allowing the sponsor to gain first mover advantage, i.e. engender brand loyalty resulting in higher and longer market share; and 4) through earlier launch, allowing for longer effective patent life or period of market exclusivity protection (Ropars and Moran 2005). As for FDA interaction, several studies have identified the positive impact of the so-called ‘meeting effect’. A study of 1987–1995 approvals identified a ‘meeting effect’ by demonstrating that average development time was 27 months shorter if sponsors had pre-IND meetings, and 16 months shorter if they had an end-of-phase II (EOP II) meeting (DiMasi and Maniocchia 1997). Later, a report by consultants Booz-Allen (Booz-Allen-Hamilton Inc. 2006a, 13) on 2002–2004 new US approvals, stated that 52 per cent of sponsors that had an EOP II meeting achieved approval upon first cycle review, but only 29 per cent of those that did not have EOP II meetings were successful on first cycle. Early on, an industry survey demonstrated that nearly 90 per cent of fast track designees believed FDA interaction would be the primary benefit from fast track participation (Milne and Bergman 2001). This belief was substantiated as it was subsequently shown that fast track programme sponsors disproportionately take advantage of the opportunity for meetings with FDA staff: 81 per cent per cent of fast track product sponsors have meetings at critical development junctures, but only 57 per cent of priority non-fast track product sponsors (Tufts CSDD 2006). The FDA itself recognizes the value of meetings as Robert Temple, then Director of CDER’s Office of Medical Policy, has commented that one of the best things that FDA can do to improve quality and predictability of the review process is to meet regularly with sponsors. According to other industry observers, fast track designation indicates that the product programme has been selected by both the sponsors and FDA as one of mutual interest and priority, requiring mutual commitment to improved communication and shared understanding throughout development and review, facilitating regulatory decision-making (Milne 2007). This early and continuous dialogue enables sponsors and the agency to uncover potentially irresolvable problems early on, so that sponsors may terminate development programmes early instead of wasting effort and 2 Priority Review is a status assigned to drugs in the review queue by FDA, when they are considered to be advances over currently available treatments, prophylactics or diagnostics. Standard review is the term applied to all other products.

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expenses on irrelevant outputs or inadequately prepared submissions (Ropars and Moran 2005). This may account for the observed advantage that Fast Track products have in negotiating the approval process on the first go-round. For example, the first cycle success rate of fast track products was 58 per cent compared to non-fast track products at a 42 per cent success rate (BoozAllen-Hamilton Inc. 2006a, 8). A more recent study indicates that this benefit may be even more dramatic than previously thought as a regression analysis demonstrated that fast track designated products were one-third less likely to experience multiple cycle reviews, the only such variable of the nearly 20 examined in the analysis to achieve such a high degree of statistical significance (DiMasi and Faden 2009). Finally, an investment boost from making fast track designation public is identifiable and has been attributed to two possible effects. Early discussions with product sponsors and industry analysts have speculated that it may be due to the perception that fast track designation acts as a preview of the likelihood that a product would be given priority review status (Milne 2001). Priority review requires FDA to take first action within six months of accepting an application compared to 10 months for standard review. Alternatively, there may be a more subtle positive impact on shareholder value, stemming from the perception among investors that designation is associated overall with lower financial risk (Ropars and Moran 2005). Regardless of why it happens, it does appear to be real. Analysis by a healthcare consulting firm demonstrated a first-day return in stock valuation bump-up of 18 per cent in the immediate wake of a designation announcement, especially for small and micro cap companies (Cohen 2004). Another analysis by Tufts CSDD of 37 companies of all sizes, both biotech and drug, demonstrated that there was a statistically significant change in stock prices after fast track designation (p-value of .04), and that the difference in the percent change of stock prices, comparing before and after fast track designation, was also significant (p-value of .03). Foster innovation Both programmes make a significant contribution to breakthrough innovation3. Among fast track products, 72 per cent are new molecular entities (NMEs) or significant biologics (SBs), and for orphan products the figure is 50 per cent. Similarly, these programmes are disproportionately incentivizing breakthrough products that are also 3 Breakthrough innovation in this context refers to the development of ‘new’ drugs and biologicals, referred to here as new molecular entities (NMEs), a term used by the FDA to describe compounds that have never been approved before in the US, and significant biologics (SBs), a term coined by Tufts CSDD to describe new biological compounds that are significantly different from what’s currently available on the market. NMEs and SBs are typically considered more challenging and costly to develop than products derived by incremental innovation, i.e., improving upon already-approved products with different indications, dosage forms, etc.


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considered advances over current therapies. In 2004–2006, about 60 per cent of all ‘new’ priority approvals went through these programmes (56 per cent of all priority NMEs and 66 per cent of all priority SBs). Even though over half of all ‘new’ product approvals each year are standard review, among fast track or orphan designated approvals, just under 10 per cent are standard review status. While fast track designation arguably fosters innovation indirectly through the investment effect as well other incentivizing effects identified by Ropars and Moran, the orphan products programme does so directly by providing funding in the form of grants. Of the 72 orphan product development (OPD) grantees, who took part in a Tufts CSDD survey,4 88 per cent were affiliated with academic institutions, 6 per cent with a non-profit research centre, and only 7 per cent identified themselves as a corporate entity. Some 70 per cent of grantees said that half or more of their programme costs were covered by the grants. While nearly three-quarters of grantees reported some form of corporate sponsorship, 38 per cent of these reported that corporate sponsorship was limited (for example, providing supply of the study drug). Orphan grants are essential for academic and non-profit researchers, who garner nearly 95 per cent of grants, and undertake much of the more challenging R&D. Yet, despite these challenges, orphan grant-funded R&D has been very successful, as 86 per cent of grantees reported that their programmes had produced significant findings and 22 per cent of programmes resulted in product approvals. This success rate for approvals compares favourably with mainstream drug development (DiMasi et al. 2003). Grant-supported research targeted unmet medical needs of special patient sub-populations such as women, children, and ethnic minorities, who historically have been under-represented in clinical trials. Some 26 per cent of programmes reported that they provided information to subjects in a language other than English (including Spanish, Portuguese, Zulu, Arabic, Filipino and Chinese). Additionally, 15 per cent of grant programmes reported the use of special incentives and outreach programmes to recruit special sub-populations. Research was also conducted globally, as 22 per cent of respondents conducted clinical trials in Europe, Canada, Latin America, 4 The initial survey was in the winter of 2002–2003, and consisted of 38 questions delivered by fax and e-mail. The sample universe was comprised of all 117 recipients of FDA orphan product grants from 1991–1998. The response rate was 62 per cent (72/117). This time period was selected to provide a large enough sample for analysis without depressing compliance rates by going back too far. However, because of the long timeframes associated with orphan product R&D, the last year included in the cohort were grants awarded in 1998. A shorter follow-up survey of 66 grantees, who had already answered the 2002 survey (six were lost to follow-up), was conducted in autumn 2005. Of the 66 grantees, 59 responded (89 per cent). Thus, grant programmes had a minimum follow-up period of eight years and a maximum of 15 years).

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Israel, Philippines, Saudi Arabia, South Africa, and Turkey, with one-third of those programmes spending more than 50 per cent of their grant funds on research conducted outside the US. Novel outputs, such as new patents or utilization of novel surrogate endpoints, biological sampling techniques, statistical/analytic methods or software programmes, were reported by 36 per cent of all orphan projects in the 2002 sample. Grantees were solicited for their opinions on the effectiveness of grants for selected disease groups (n=8) and emerging research areas (n=8). Among the top rated disease groups were genetic diseases, neurological disorders, and infective diseases, while the research areas most frequently selected were drug delivery, diagnostic tests, and gene therapy. These areas are generally considered by the entire biopharmaceutical research community to be among the most urgent and high-risk unmet medical needs. In addition, programmes like fast track and orphan products appear necessary to nurture the more innovative segment of the industry. Small biotechnology companies without the intercession of special regulatory programmes seem to do worse at getting their products through the approval process, a fact attributed to a lack of personnel with regulatory experience. For example, a recent FDA commissioned report found that small biotechnology companies with no prior FDA approvals were found to have half the first cycle approval rate of large US-based companies (Booz-Allen-Hamilton Inc. 2006a: iii). Similarly, the two oldest orphan product programmes – in the US and Japan – were both credited with helping to get fledgling biotechnology sectors off the ground, in the early and late 1990s, respectively (Shiragami and Nakai 2000). Involve stakeholders Increasing participation over time as well as continuation and expansion of these programmes by regulators and legislators indicate that these programmes are ones that work, but do they also evince a key characteristic of governance: involvement of stakeholders – industry, researchers and patients? The ODA was crafted in response to patient advocacy and maintains that legacy after more than two decades. The influence of the National Organization for Rare Disorders (NORD) on passage of the ODA is widely acknowledged (ODA Amendments 1992). NORD, which acts as a cooperative of over 100 disease-specific patient advocacy groups, functions as a paradigmatic policy network in governance terms. NORD maintains a database of patients with rare diseases who register and will inform them of clinical trials that may be of potential interest to them, especially when a new treatment is discovered. NORD will not give out patient information to investigators, companies or other third parties. When a new orphan product reaches the market, NORD will continue to educate patients on positive and negative aspects of the new treatment but not advise them on individual treatment decisions (it maintains a network of medical advisors). NORD will also help academic investigators locate sources of funding and funds some


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small clinical trials itself. NORD will assist FDA with difficult decisions such as which patients will receive an investigational drug in the case of Treatment INDs5 and also administers an indigent care programme for patients that cannot afford treatments. NORD will work directly with companies but not trade organizations (Meyers 2000). According to a government investigation in the early 2000s, public stakeholder needs are being adequately addressed by the FDA’s orphan drug programme, as it found that: patients said drugs were generally accessible, however sometimes in short supply; insurance typically covered the cost; and, there were programmes for patients who could not pay (OIG 2001). The report recommended that no changes needed to be made to the orphan products programme. Furthermore, the innovation community of both industry and academic investigators have said that while they questioned some individual product decisions they were generally laudatory of the orphan products programme (OIG 2001). In similar vein, a majority of respondents to a survey of orphan grantees, who were primarily academic investigators, noted that both the application and reporting processes for FDA grants were very manageable. Survey respondents also acknowledged the importance of organized advocacy to their efforts. When asked what FDA could do better to publicize their awards, more grantees chose outreach to patient advocacy than the other three options presented6 (Milne 2004). Fast track too has considerable buy-in from stakeholders. A study of the fast track effect by outside consultants funded by the FDA found that increased regulatory and sponsor attention throughout the drug development and review process may contribute to the timely identification and resolution of issues, and that the FDA may engage in more pre-submission communications with sponsors for products with these designations (Booz-Allen-Hamilton Inc. 2006a:iii, 7-8). For FDA, early review of parts of the approval dossier was not overly burdensome although there was some concern about the increase in workload and the potential for non-PDUFA7 work being de-prioritized. For sponsors, the programme was thought to help distribute sponsors’ workload, and to get a head-start on the additional time required to address issues arising 5 Treatment INDs (investigational new drugs) is a special FDA programme allowing companies to provide an experimental drug to a wider number of patients while it is undergoing development, typically during Phase III studies, as long as there is preliminary evidence of drug efficacy and the drug is intended to treat a serious or lifethreatening disease (for example, advanced cases of AIDS, herpes simplex encephalitis, and subarachnoid haemorrhage), or if there is no comparable alternative drug or therapy available to treat that stage of the disease in the intended patient population. In addition, these patients are not eligible to be in the definitive clinical trials. 6 Thirty-seven per cent versus 25 per cent for publication on FDA website, 19 per cent for outreach to specialists; and 19 per cent for publication in general medical information outlets. 7 Prescription Drug User Fee Act.

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from parts of the approval dossier that sponsors were allowed to submit early under the programme. However, as for scientific interaction, FDA reviewers in some divisions believe that the process already closely mirrored their typical operating procedures for life-threatening diseases. Sponsors valued the commitment for timely FDA feedback and said that it helped them to better plan their product development programmes, but some eligible sponsors chose not to apply because of the perception that the level of FDA involvement during the IND would not significantly differ from the level of attention that they would receive in any case for their products because they targeted lifethreatening diseases.8 Patient advocacy groups were also instrumental in securing passage of the FDA Modernization Act of 1997 (FDAMA), which codified existing FDA programmes to create fast track (Fred 2003). Patient advocacy groups are still being utilized by FDA to induce pharmaceutical companies to make information about ongoing fast track trials available on the clinicaltrials.gov website through initiatives like the Kidney Cancer Association’s policy not to list a clinical trial on its website unless the trial is first listed with clinicaltrials. gov (FDA 2005, 43). In addition, the fast track programme has helped specific advocacy lobbies such as the one for global AIDS, which has benefited from the programme’s use under the President’s Emergency Plan for AIDS Relief (PEPFAR) to get expedited review and tentative approval of applications for fixed dose combinations and co-packaged antiretroviral medications (nearly a dozen approvals in a little over two years). Industry has indirectly alluded to the value of fast track in a series of interview studies, which repeatedly identified that one of five success factors for expediting product approvals is productive collaboration with regulatory authorities (Frantz 2006). Address unmet medical needs The Orphan Drug Act by definition is targeted towards economic orphans for which market exclusivity acts as an incentive because these products are typically the only available therapy, thus addressing unmet medical needs. The ODA has made treatments available for more than 14 million patients in the United States. Moreover, a working paper by two economists (Lichtenberg and Waldfogel 2003) has found rapid growth of prescription drug consumption by individuals with rare diseases since passage of the ODA, resulting in fewer deaths, increased longevity (seven years versus two years for patients with non-orphan diseases), as well as quality of life benefits. In terms of its impact in certain disease areas, there were 24 orphan product approvals for AIDS treatments (until AIDS no longer qualified as an orphan disease in 1992), and 37 for rare cancers, which was a four-fold increase over the pre-ODA period (Milne et al. 2001). Yet, when the ODA 8 It should be noted, however, that this refers to evaluation of the Continuous Marketing Application (CMA) pilot programme, which was similar to Fast Track, but of a more intensive nature. The pilot programme was discontinued.


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was passed, rare cancers and HIV/AIDS were not recognized as public health problems, (Haffner 1994) highlighting the adaptability of the ODA to new areas of unmet medical needs, as well as its responsiveness to stakeholder advocacy. The influence of the AIDS Action Council and the National Cancer Society has been acknowledged in the public record. Fast track designation by law can only be granted to development programmes addressing unmet medical needs. Survey results indicate that among 23 fast track drug development programmes, 20 indications were for adults, while 21 of the indications were also being studied for paediatric age groups (Milne and Bergman 2001). While cancer and HIV/AIDS still account for close to 50 per cent of fast track designations, now more than 100 other diseases are being targeted by fast track programmes including bioterror countermeasures, pandemic threats such as bird flu, and neglected diseases such as sleeping sickness (Tufts CSDD 2006). Control risk Based on the percent of 1998–2005 NME and SB approvals that have acquired Black Box warnings, indicating an elevated safety risk, orphans are no more risky than non-orphans with 26 per cent of both orphans and non-orphans having Black Boxes. For fast track, 34 per cent of NME and SB approvals have acquired Black Box warnings, while for non-fast track only 25 per cent have acquired Black Box warnings.9 However, there have been no permanent withdrawals for safety reasons of NMEs and SBs approved with orphan or fast track designation, but five withdrawals for safety reasons for marketed products without orphan or fast track designations.10 For products with fast track or orphan designation, 5.8 per cent of products have been discontinued or withdrawn and later returned to the market for limited distribution, compared to a rate of 8.2 per cent for products without fast track or orphan designation. In the aggregate, considering the more serious nature of fast track and orphan diseases, and hence the greater benefits accruing to treatment, products from these designation programmes could be considered to have a more favourable risk/benefit balance than undesignated drugs.

9 Black Box warning (also sometimes called a black label warning or boxed warning) is a type of warning whose text appears on the drug’s package insert surrounded by a black box. When such a warning is required by the US FDA, it indicates that the drug carries a significant risk of serious or even life-threatening adverse effects. 10 Based on new drugs and biologicals (i.e., NMEs and SBs) approved from 1998 to 2005, a period of time that coincides with years when both programmes were operational and that allows sufficient time for safety hazards to have been identified which typically takes a minimum of two years on the market.

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Broader Applicability In addition to determining if these FDA programmes are ‘what works’ in the context of the governance agenda, we should consider whether they ‘will work’ outside of the US regulatory system and free market economy, and within the changing environment for biopharmaceutical R&D. Thus, three questions remain. How applicable are these governance programmes in other economies? Can they serve as model programmes for a governance approach to promoting other new health care technologies? Will they flourish or founder in the new biopharmaceutical paradigm? Applicability to Other Economies Orphan programmes rely on a market-oriented strategy for incentivizing orphan drug development, by permitting the successful developer to create its own market force through regulatory exclusivity (Thamer 1998). This works well within a free market economy. However, one perceived problem has emerged over time, the so-called ‘blockbuster orphan’. A few orphan products have been sold at what some have viewed as very high prices, portrayed as outof-sync with the magnitude of the R&D investment. Even though there are actually very few blockbuster orphans (Grabowski 2000), the circumstances creating unexpectedly high ROI are less likely to be caused by inelastic demand and consequent price insensitivity (i.e. an exorbitantly priced life-or-death drug), than to off-label use and foreign markets (Peabody 1995), or to other circumstances unanticipated at time of approval, such as changes in clinical guidelines for epoetin, which resulted in a three-fold increase in the amount that kidney dialysis patients receive (Berenson 2006). How well do these programmes function in a public goods economy or emerging economy? Outside of the free market, market exclusivity of seven years (or 10 years in Europe) can still provide a strong incentive to orphan drug sponsors by creating conditions for monopoly pricing. However, market exclusivity as an incentive is linked with country-specific pricing and reimbursement policies. This monopoly status may not be sufficient when (1) the cost structure for an orphan drug is inconsistent with that of other pharmaceutical products (that is, it is too expensive to develop compared to other competing R&D opportunities), or (2) if demand is sensitive to changes in price (that is, it is so expensive that too few can afford it, or third-party payers cannot reimburse) (Milne et al. 2001). The former circumstance could occur in an emerging economy. However, its impact would be limited by the fact that rare diseases are exactly that – rare, so the apparent lack of utility of an orphan programme would be premised on making choices among competing public health priorities rather than such an approach being inherently dysfunctional under this economic model. Realistically, however, the most promising route thus far for less developed


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countries to address unmet medical needs has been through the emergence of a new type of policy network – public-private partnerships. As the orphan and fast track programmes represent a metamorphosis of policy instruments in governance, so too do public-private partnerships represent a departure from the archetypical model of a policy network. In this case, the network is concerned with a particular problem or set of problems, and provides the necessary integration of disparate stakeholders focused on a single goal, but also serves the role of carrying out the socially desirable goal rather than merely influencing the decision as to what actions are taken. Alternatively, orphan programmes do not necessarily have to even facilitate indigenous R&D to be successful. For example, Singapore’s orphan drug law features expedited importation of orphan products approved by recognized foreign regulatory authorities. The latter circumstance (that is, orphan drugs become too expensive for reimbursement) could occur in a public goods economy. However, previous studies have demonstrated that orphan products are cost-effective, and third party payers have determined that because the relative numbers of rare disease sufferers covered by any one programme is usually small, so are the respective expenditures. While maintaining the basic feature of fostering a sustainable business model for orphan R&D, various regions with public goods economies have adapted the ODA to their particular philosophies of government. For example, in Japan, orphan product development is considered a social duty for large companies with the result that most orphan designations are for additional indications of existing drugs and over 40 per cent of the applicants are foreign-affiliated companies (Shiragami 2000). Europe’s 2000 orphan drug law incorporates more of a governance approach with several avenues for integration of member states and policy networking among a working group consisting of interested parties from the regulatory agencies, industry and patient groups and a task force comprised of current and past community health project leaders, experts nominated by member states, and representatives of relevant international organizations (such as the EMEA, WHO and OECD). At the nexus of all three economic models is the urgent challenge to produce cheaper drugs in more developed countries to treat major neglected diseases (such as AIDS, malaria, and tuberculosis) in less developed countries (Tait et al. 2006, 391). While an incentive based on enhanced market protection (or possibly a transferable priority review voucher as recently provided by legislation in the US, see FDAAA 2007) may be sufficient for an established company with a product to market, nonetheless, start-up biotechnology firms or speciality pharmaceutical companies, also need incentives that lower the costs for entering high-risk, low-return areas of research. Some believe that tax credits and grants are insufficient to accomplish this. Neglected disease advocates, for example, have long advocated that another incentive element is needed – such as accelerated authorization procedures (Olliario 1997).

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Accelerated procedures for final authorization and exemptions from all or part of the registration fee can reduce development costs, staffing requirements, and time to market, making the product a more attractive prospect to industry (Lang 1999). Our analysis of fast track and orphan programmes shows that they provide similar benefits. Thus, one way to address the unmet medical needs in less developed countries is by enhancing and expanding incentive programmes in more developed countries that combine elements of both fast track and orphan designations, together with prioritization of neglected diseases. New Technologies The utility of a governance approach for incentivizing biopharmaceutical R&D in various economies through programmes similar to fast track and orphan together with policy networks seems theoretically possible. However, will such an approach also help to promote emerging technologies necessary to advance the R&D of new medicines, such as genomics and stem cell research? The problem with genomics is one of magnitude, magnitude of risk, both financial and public health. New applications of genomics call for much greater levels of financial support than is provided by current mechanisms to support biotechnology commercialization, perhaps by one or two orders of magnitude with the shift from biotechnology to genomics (Spinardi and Williams 2005, quoting Peter Ghazal, 47). There is, in fact, a need not only for a new regulatory approach, but in fact, a new relationship between state and industry, because genomic innovation is too risky for private sector investors to sustain without a significant period of incubation in the public sector (Moran 2007). Again the applicability of an evolved governance approach to a wider swath of STI would appear to require application of the policy network component along the lines of a public-private partnership approach, or other risk-sharing approaches such as R&D consortia. The challenges confronting stem cells are financial and public health, but also political. As with AIDS in the 1980s, R&D inertia could be overcome by a strong advocacy movement, involving both informational and lobbying efforts. However, there is no one group that has emerged as stakeholders with equal conviction and resources to promote stem cells to counterbalance those opposed. Therefore, a policy network of innovation communities, public health agencies, and patient/consumer groups would appear to be the most likely vehicle for providing the political impetus to foster such an effort. If such a policy network can maintain funding flow to nourish the field long enough, it may eventually gain public acceptance or invent around aspects of the technology that are politically contentious.


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New Paradigm Given that orphan and fast track are a reflection of the direction of drug development as a whole, characterized by more specialized patient populations, involvement of a broader range of research entities, and a more difficult clinical development environment, then the governance approach that these programmes evidence may become critical to reshaping the current R&D paradigm. The governance agenda is particularly concerned with the role of SMEs in this evolution. In particular, do government policies that support small, dedicated biotechnology firms only serve to indirectly support the development costs of multinational companies, that is, small firms are dependent on the multinational corporation for the commercialization of their products and generally their aim is to be taken over by them (Tait and Williams 1999)? The need for small companies to make themselves attractive acquisition targets constrains their innovation strategies and restricts them to products that are compatible with the strategies of the multinationals, rather than potentially competing with them (Chataway et al. 2006). It would seem that this concern is only partially supported by our findings. At the same time, the implications for the eventual configuration of the paradigm may be different from what was expected. Among both orphan and fast track programmes, SMEs are increasingly shepherding products all the way through to approval, (increase from a 12.5 per cent to 37 per cent share of fast track approvals, and from 39 per cent to 58 per cent of orphan approvals) but as a group, they seem to be better characterized as specialty pharma rather than start-up biotech companies. For example, in orphan product R&D, biotechs garner a significant share of designations, but are much less of a factor for approvals. In the fast track realm, biotechs do not even garner the lion’s share of designations (41 per cent), and account for only about one quarter of approvals. Thus, SMEs are emerging as a product-generating sector in their own right, just not necessarily a biotech sector. Recent news articles suggest why this may be occurring. The drop-off in reimbursement rates in Europe and anticipated in the US under a Democratic Congress as well as the timidity of venture capital in the context of biotech has resulted in more emphasis on small molecule drugs (mostly follow-ons, with work being farmed out overseas) and start-up biotechs reverting to acquisition instead of IPOs as an exit strategy (Mitchell 2006; Crabtree 2006; Hirschler 2006). Perhaps a better assessment of the current reality is expressed by the following statement from governance observers that there is an ‘… increasingly fluid and turbulent set of relationships and interactions among small, medium and large companies and their markets’ (Chataway et al. 2006). In addition, market forces are driving the movement away from onesize-fits-all products for the primary care sector to a specialty care focus, and paving the way for further segmentation of the market along the lines of personalized medicines or at least stratified patient sub-populations. The

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increasing contribution of orphan and fast track drugs to the pipeline of drugs in development and reaching the market is evidence of their pivotal role in this transition. Overall, from 1983 to 1998, the number of orphan drugs available increased five-fold, while the output of non-orphan drugs merely doubled (Lichtenberg 2003, 58). In the mid-2000s, there were an estimated 800 orphan drugs in development (Lassoff 2005), or approximately one-third of all drugs in the clinical phase worldwide, of which a significant number may also have fast track designation. At the market end, the proportion of ‘new’ drugs and biological product approvals in the US with fast track or orphan designation rose dramatically from 27 per cent in 1998–2003 to 38 per cent in 2004–2006 (Tufts CSDD 2007, unpublished data). Conclusion If the intent of government is to create a sustainable and competitive biopharmaceutical industry, not a public utility or charitable enterprise, then government intervention must employ a proactive problem-solving approach, not reactive proscription based on inflexible and arbitrary standards that disregard the public health reality of balancing risks and benefits as well as the economic reality of biomedicines R&D as a business. Orphan and fast track are exemplars of government programmes that function as governance tools at the regulatory system level. What is also important is that they are examples of ‘what works’. Combining industry incentives, increased government intervention, and stakeholder inclusiveness can be an efficient approach for promoting STI that is not contrary to a governance agenda of encouraging both private sector investment and public engagement in a common goal. In an even larger context, a top down but problem-solving approach, may have utility for fostering international competitiveness and preserving the potential for profitability across a spectrum of economies and technologies, while still maintaining public confidence and addressing public health priorities among numerous unmet medical needs. Although there is tension between the promotional role of a regulatory agency and its public health oversight role, this can be mitigated by identifying and addressing problems through the effective mediation of targeted policy networks composed of dedicated professionals and patient/consumer advocates. Nor do the tensions inherent in policy networks discussed earlier in this volume, such as institutional inertia or regulatory capture, have to necessarily be incapacitating. Again, the lubricant that permits the programmes discussed in this chapter to move freely to accomplish their goals seems paradoxical – more oversight and more formality. In the case of the former, sponsor product programmes receive greater regulatory scrutiny, but the level of scrutiny is tacitly agreed upon up-front, and so far has resulted in tangible benefits in terms of expediting approvals while so far demonstrating the capacity to


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appropriately balance risks and benefits. In the case of the latter, agency guidance documents as well as a policy/procedure manual delineate roles, while advisory committees comprised of experts and the historical hegemony of a patient advocacy group well-integrated into the process, such as NORD, serve as checks and balances for undue industry influence or unbridled agency action. There is a limit to the utility of this model, however, as acknowledged earlier in this volume; that limit in essence is framed by the bargain that how much control the government can give up is in direct proportion to how much self-interest the governed are willing to give up. Thus, governance tools like orphan and fast-track work best when the public health goals are manifest and the financial rewards are modest. Fortunately, competitive pressures and public sentiment are moving the whole industry in that direction. The specialty care focus of new medicines, the demise of the blockbuster, the rise of the mini-blockbuster for unmet medical needs, pharmacogenomic targeting on safety, as well as price premiums for comparative effectiveness have opened the door for the exceptional to become the norm. References Berenson, A. (16 November 2006), ‘Heart Risk Seen in Drug for Anemia’, New York Times (published online), . Booz Allen Hamilton Inc. (2006a), Independent Evaluation of FDA’s First Cycle Review Performance – Retrospective Analysis Final Report, prepared for FDA (Contract No 223-04-8100, Task No. T1). Booz Allen Hamilton Inc. (2006b), CMA Pilot 1 Evaluation and Pilot 2 Preliminary Evaluation Studies – Final Report, prepared for FDA (Contract No 223-04-8100, Task No. T2). Castel, B. (2005), ‘The Next Generation of Health Care’, Wall Street Journal, 12 July: B2. Chataway, J., Tait, J. and Wield, D. (2006), ‘The Governance of Agro- and Pharmaceutical Biotechnology Innovation: Public Policy and Industrial Strategy’, Technology Analysis and Strategic Management 18:2, 169–85. Cohen F.J. (2004), ‘The Fast Track Effect’, Nature Reviews/Drug Discovery 3, 293–4. Crabtree, P. (2006), ‘Good Old Days Gone for Biotech’, 11 November, UnionTribune, available at . DiMasi J, Maniocchia M. (1997), ‘Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-sponsor Conference’, Drug Information Journal 31:3, 771–88. DiMasi, J.A. et al. (2003), ‘The Price of Innovation: New Estimates of Drug Development Costs’, Journal of Health Economics 22:2, 151–85.

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DiMasi, J.A. and Faden, L. (2009), ‘Factors Associated with Multiple FDA Review Cycles and Approval Phase Times’, Drug Information Journal 45:2, 201–25. Food and Drug Administration Amendments Act (2007), P.L. 110-85, September, available at . FDA (July 2004), Guidance for Industry: Fast Track Drug Development Programs —Designation, Development, and Application Review, available at . FDA (August 2005), FDAMA Section 113:Status Report on Implementation, , last accessed 21 August 2008. Frantz, S. (2006), ‘Study Reveals Secrets to Faster Drug Development’, Nature Reviews Drug Discovery 5:November, 883. Fred, S. (2003), ‘The Biotech Boom’, The Capital Eye, 9 July (published online) , last accessed 29 November 2007. Grabowski, H.G. and Vernon, J. (2000), ‘The Distribution of Sales Revenues from Pharmaceutical Innovation’, Pharmacoeconomics 18:l, 21–32. Grabowski, H.G. (2005), ‘R&D Costs and Revenues and the Development of New Vaccines’, University of Chicago Conference on Vaccines 13 May. Grace, C. (2006), ‘Developing New Technologies to Address Neglected Diseases: The Role Of PDPs and AMCs’, presentation, DFID Health Resource Center September, available at . Haffner, M.E. (1994), ‘Applications of the Orphan Drug Act to Special Patient Populations’, Drug Information Journal 28:2, 495–503. Hirschler, B. (2006), ‘Big Pharma Cash Keeps Biotech on a Roll’, Reuters 20 November, available at . Lang, J. and Wood, S.C. (1999), ‘Development of Orphan Vaccines: An Industry Perspective’, Emerging Infectious Diseases 5:6 (November– December), 749–56. Lassoff, P. (2005), ‘Speeding up the Regulatory Process’, presentation, PAREXEL Consulting. Lewis, G. and Fearn, C., (May 2006), ‘IMS Health Pharma Horizons Seminar’, NYC, available at . Lichtenberg, F.R. and Waldfogel, J. (June 2003), ‘Does Misery Love Company? Evidence from Pharmaceutical Markets Before and After the Orphan Drug Act’, NBER Working Paper No. W9750. Lyall, C. and Tait, J. (eds) (2005), New Modes of Governance. Developing an Integrated Policy Approach to Science, Technology, Risk and the Environment (Aldershot: Ashgate). Lyall, C. (2007), ‘Governing Genomics: New Governance Tools for New Technologies?’, Technology Analysis and Strategic Management 19:3, 365–82.


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Meyers, A.S. (2000), ‘Collaboration Between the Pharmaceutical Industry and Patient Organizations. A Delicate Balance’, speech by president of NORD, International Conference of Rare Diseases and Orphan Drugs, 17 February. Milne, C-P., Kaitin, K.I. and Ronchii, E. (2001), ‘Orphan Drug Laws in Europe and the US, Incentives for the Research and Development of Medicines for the Diseases of Poverty’, Commission on Macroeconomics and Health, CMH Working Paper Series. Paper No. WG2:9 (published online), , accessed 21 October 2005. Milne, C-P. and Bergman, E. (2001), ‘Fast-track Designation under Food and Drug Modernization Act: The Industry Experience’, Drug Information Journal 35:1, 71–83. Milne, C.-P. (2004), ‘Orphan Product Grants: Are they Getting the Job Done?’, presentation, 2004 Drug Information Association Annual Meeting, Washington, DC. Milne, C.-P. (2007), ‘Fast Track, Pediatric, Orphan and Global Diseases R&D’, presentation, Postgraduate Health Care Research course (Tufts University). Milne, C.-P. (2008), ‘Getting from Challenge to Change: How Far? How Fast?’ presentation, 6 August, IBC DDT, R&D Strategies Session (Boston, MA). Mitchell, S. (2006), ‘Analysis: CROs May Prosper under Democrats’, UPI Health Business, 16 November, available at . Moran, N. (2007), ‘Public Sector Seeks to Bridge “Valley of Death”’, Nature Biotechnology 25:3 (March), 266. Office of the Inspector General, US Department of Health and Human Services (2001), The Orphan Drug Act Implementation and Impact, May, Document # OEI-09-00-00380. Office of Orphan Products Development, FDA (2007), website, available at . Olliario, P (1997), ‘Will the Fight against Tropical Diseases Benefit from Orphan Drug Status?’, Tropical Medicine & International Health 2:2 (February), 113–15. Orphan Drug Amendments of 1992 (1992) ‘Report from the Committee on Labor and Human Resources’, United States Senate Report 102‑358, 102d Congress 2d Session (Washington DC: US GPO). Organization for Economic Cooperation and Development (2006), Emerging Research Models for the Delivery of Health Innovation Project, OECD’s Working Party on Biotechnology (WPB) and subsidiary, Working Group on Human Health Related Biotechnologies (WG-HHRB). Orphan Medicinal Products, EMEA website, available at ; RDTF website, available at .

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Peabody, J.W., Ruby, A. and Cannon, P. (1995), ‘The Economics of Orphan Drug Policy in the US. Can the Legislation be Improved?’, PharmacoEconomics 8:5 (November), 374–84. Reichert, J.M. et al. (2009), ‘Finding Value in the US Food and Drug Administration’s Fast Track Program’, Drug News Perspectives 22:1, 53–8. Ropars, A.L. and Moran, M. (Jan 2005), ‘Fast Track Options as a Fundraising Mechanism to Support R&D into Neglected Diseases’, Pharmaceutical R&D Policy Project (London School of Economics) (published online) , last accessed 21 August 2008. Shiragami, M. and Nakai, K. (2000), ‘Development of Orphan Drugs in Japan: Characteristics of Orphan Drugs in Japan’, Drug Information Journal 34:3, 839–46. Spinardi, G. and Williams, R. (2005), ‘The Governance Challenges of Breakthrough Science and Technology’, in Lyall, C. and Tait, J. (eds) New Modes of Governance. Developing an Integrated Policy Approach to Science, Technology, Risk and the Environment (Aldershot: Ashgate). Tait, J., Wield, D., Chataway, J. and Bruce, A. (2008), Health Biotechnology to 2030, Report to OECD International Futures Project, ‘The Bio-Economy to 2030: Designing a Policy Agenda’ (OECD: Paris, 51), , accessed 21 July 2008. Tait, J. (2007), ‘Systemic Interactions in Life Science Innovation’, Technology Analysis and Strategic Management 19:3 (May), 257–77. Tait, J., Chataway, J., Wield, D. and Lyall, C. (2006), ‘Governance, Policy and industry Strategies: Pharmaceuticals and Agro-biotechnology’, in Mazzucato, M. and Dosi, G. (eds), Knowledge Accumulation and industry Evolution: The Case of Pharma-Biotech (Cambridge: Cambridge University Press), 378–401. Tait, J. and Williams, R. (1999), ‘Policy Approaches to Research and Development: Foresight, Framework and Competitiveness’, Science and Public Policy 26:2, 101–12. Thamer, M., Brennan, N. and Semansky, R. (1998), ‘A Cross-National Comparison of Orphan Drug Policies: Implications for the US Orphan Drug Act’, Journal of Health Politics, Policy and Law 23:2, 265–90. Thaul, S. (2008), ‘FDA Fast-track and Priority Review Programs’, CRS Report for Congress (#RS22814). Truelove, C. (2007), ‘Belt Tightens on Big Pharma: 21st Annual Report, Top 50 Pharma’, Med Ad News (September), 4–22. Tufts Center for the Study of Drug Development Impact Report (2006), Kaitin, K.I (ed.) Fast Track Program Firmly Established in US Drug Development Landscape 8:2.

Chapter 6

Governments and the Governance of Bioscience as a ‘New Security Challenge’ Paul Nightingale and Caitríona McLeish

Introduction The problem posed by biological weapons has been traditionally understood as being one that can be reasonably adequately addressed by governments through international agreements and national laws. In particular, the 1925 Geneva Protocol and the 1972 Biological Weapons Convention (BWC) have been historically successful examples of international prohibitions that have played a key role in steering states away from the acquisition and use of biological weapons. However, there is now recognition that the problems posed by biosecurity go beyond only government involvement and government-instigated solutions and that other stakeholders such as private industry, academia, professional organizations, scientists, non-governmental organizations need to be actively involved. This apparent move from ‘government’ to ‘governance’ gives rise to its own sets of problems. How, for example, are new actors enrolled in policy making and its implementation? Who enrols them and what role are they to take? What agendas do they bring and are these agendas competing or compatible? And how should academics and policymakers understand this change? In this chapter we attempt to contextualize the policy problems associated with biosecurity and show how a small part of the policy problem has been addressed within the UK. In doing so, we draw on the work of Krause and Williams (1996) and Rosenberg (2001) to suggest that understanding these changes within certain frameworks might potentially be misleading. In particular, that it is misleading to see them as part of a shift from government to governance that has been driven by globalization. Specifically the claim that ‘deepening interconnectedness [is] fundamentally transforming the nature of human society, and replacing the sovereign state system with a multi-layered, multilateral system of “global governance”’ (Rosenberg 2005, 2). We then go on to suggest that while at first these changes would seem to provide a perfect example of the emergence of what Beck (1992) calls the ‘risk society’, closer investigation reveals problems with that approach.

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From States to Non-State Actors The 1972 BWC was part of a series of interconnected international regimes set up largely under US influence and operated through international bureaucracies, such as the UN and its various bodies. These legal frameworks and international organizations mediated superpower conflict throughout the Cold War and provided the legal frameworks for the post-war expansion of international trade (Sands and Klein 2001). Biosecurity sat very clearly within a wider set of concerns about military technology, particularly chemical and nuclear weapons and the wider security problem was largely, if not almost exclusively, focused on states and responses to the specific problem of the USSR and its allies. With the collapse of the Soviet Union and the end of the Cold War the security environment has changed fundamentally. The US, and those allies it chooses to support, now possesses such overwhelming military dominance that no other conventionally armed state poses any substantial threat. As a consequence, there has been a shift in focus from states to non-state actors who are now seen as sources of threats through civil wars (often defined along ethnic lines), transnational criminal networks, the flow of new infectious diseases, international terrorist networks, etc. It has therefore been suggested that the scope of security should change to address threats to individuals and populations that transcend national boundaries to include such things as food and water security and global warming.1 As a result, a range of new actors, who have to a large extent not played a central role in security within the Cold War framework, now play a key part. At the regional, national, and international level, non-governmental organizations (NGOs), civil society, international lawyers and private security companies now play significant roles in addressing these new security concerns. This can be seen as a two-fold shift, firstly, in the nature of the security problem, and secondly, a new form of organizational response based on a more networked organizational structure of ‘outsourced service provision’, either through NGOs, or in some instances through private security firms. In both instances there is a shift from states to non-state actors as both sources of threat and resources for response, in short, a shift ‘from government to governance’. The problems of providing security that are generated and addressed by this new, networked structure have been christened ‘New Security Challenges’, where what is new is not the challenges (no-one suggests that civil war or infectious diseases did not occur during or before the Cold War) but the response, and particularly, the response as it is conceptualized within social theory.

1 The Second Gulf War might lead one to question the assertion that state to state warfare is a thing of past, but the resulting insurgency suggests even here we have what Kaldor (1999) would call a New War.

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Biosecurity ‘Under the Influence’ of Globalization Theory These shifts within the focus and organizational structure of security context fit within a wider range of patterns of social change that have been picked up and theorized under an over-arching umbrella of globalization theory: an overlapping body of social theory that has explored the post-Cold War shift towards a more international, networked, decentralized, market based society. While there is variation in what is attributed as the cause of these changes, the basic pattern being proposed is that over the last 20 years there has been an increase in global trade, telecommunications, travel, culture and that this shift is related to changes in the nature of state, from a geographically bounded entity towards a more networked, interconnected institution, that is diffusing sovereignty above – to supra-national institutions such as the EU and international law – and below to the regional and local level as non-state actors play a larger role in the provision of what were previously state provided services. The various theories that come under the globalization umbrella assert (to varying degrees) that the shift from states to non-state actors has been accompanied by: • a shift from national to multinational/multilateral forms of governance; • a general shift towards increased prominence of market-based solutions and policies; • a related shift towards deregulation; • a shift towards increasing the role of civil society; • shrinkages of the state (often in relation to welfare provision); • a general increase in trade, communications and the importance of technology and knowledge within the economy and society more generally; • changes in the ‘social distribution of risk’, possibly related to the emergence of a ‘risk society’; • ‘cultural’ responses to these changes as social groups negotiate divergent norms and construct their identities in relation to these societal changes, and in doing so, constitute society. Such changes have been conceptualized along a range of positions from techno-determinist neo-Marxist frameworks, where changes are driven by (information) technology, or within a neo-Foucauldian framework, driven by new distributions of bio-power directed at populations rather than geographic territory. Current changes in biosecurity would seem to fit this pattern particularly well. With the end of the Cold War, and particularly after the posting of letters laced with the causative agent of anthrax in 2001, there is now increased

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attention on the terrorist threat within biosecurity policy. The collapse in 2001 of efforts to strengthen the BWC with a verification protocol has seen a swing from state to non-state actor inspired initiatives and a simultaneous effort made to enrol non-government stakeholders in the provision of security. At the international level new policy initiatives are being proposed which specifically target these groups – for example efforts to create a code of conduct for life scientists. Similarly, national governments are under pressure to increase their outreach in an effort to encourage these stakeholders to recognize the risks associated with dual-use materials, equipment, and knowledge. Some nongovernment stakeholders are instigating their own proposals for new risk management strategies – for example, some journal editors have proposed a method to review papers prior to publication for security sensitive content. (McLeish and Nightingale 2007); the International Council for Life Sciences is examining the feasibility of setting up a body to encourage safe and secure operation of facilities and the Center for International and Security Studies at Maryland has proposed a global system for the regulation of dangerous pathogens. Non-proliferation measures such as the Australia Group and the Wassenaar Agreement highlight the importance of (formal and informal) inter-governmental agreements in governing security and represent a shift from a central authority towards more horizontal relationships. It would seem that the changing globalized biosecurity environment provides ample evidence to support both the globalization/new security challenges paradigm. On closer examination, however, questions arise about the validity of the approach in addressing recent changes in biosecurity. The collapse in 2001 of efforts to enhance the BWC has seen a radical shift from multi-lateralism to a substantially reinforced state-based approach to governance, and not a shift from states to multilateral fora. Rather than a shift towards international law and diffusion of state sovereignty to supra-national bodies, we have seen a shift away from security through international law, the reassertion of state sovereignty against international bodies, particularly under Bush II. This has resulted in a substantial political weakening of international bodies, particularly the UN. Again the opposite of what the theory predicts. Rather than seeing a shift toward de-regulation there has been a substantial increase in state-based controls related to biosecurity (McLeish and Nightingale 2007). For example, in the USA the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA Patriot) Act 2001 reinforces the security aspect of select agent controls by requiring that ‘no restricted person’ shall possess, transport or receive any biological agents or toxins listed in the Act as select agents. Similarly the Public Health Security and Bioterrorism Preparedness and Response Act 2002 stipulates that before working with, or having access to, any select agent the Act requires that all those wishing to possess, use, or transfer such agents and toxins, undergo registration to ensure that they are permitted to perform those


activities, i.e. that they are not restricted persons. This includes undergoing a security risk assessment (including fingerprinting) by the FBI and then being granted approval (based on that security risk assessment) by either the Centers for Disease Control and Prevention (CDC) or the US Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), before gaining access to select agents or toxins.2 The UK has a similar select agent list which can be found under Schedule 5 in the Anti Terrorism Crime and Security Act 2001. Currently the list contains 19 viruses, five rickettsiae, 13 bacteria, 11 toxins and includes genetic material associated with any one of the agents or genetically modified organisms containing a sequence of a listed agent. Legal obligations are placed on the occupier of any premises to notify the Secretary of State before any dangerous substance is kept or used there. It is similarly questionable to assert that infectious diseases have come to be a bio-security concern because traditional state centric security concerns have shrunk and been replaced by new challenges related to naturally emerging infectious diseases. Despite this being a very serious potential problem (Weiss and McMichael 2004) there has been a shift in resources from ‘new security challenges’ posed by emerging infectious diseases to ‘old security challenges’ related to state based biological weapons (BW) programmes. For example, in the US total National Institutes of Health (NIH) funding for biodefence has increased from $25m in FY 2001, to a peak at $1,748m in FY 2003 before falling slightly to $1,600m in 2004 (Harris and Steinbruner 2005). The majority of this funding in 2003 went to the National Institute of Allergy and Infectious Diseases (NIAID) where 50 biodefence initiatives were developed in fiscal years 2002 and 2003.3 These increases in funding have shifted the direction of life science research towards pathogens with potential hostile use and away from emerging infectious diseases. The number of grants awarded for research on BW agents, for example, has risen 1,500 per cent from ‘33 between 1996-2000, to almost 500 between 2001 and January 2005’ (Harris and Steinbruner 2005, 1). As a result more than 300 institutes and 12,000 individuals in the US now have access to pathogens historically associated with bioweapons and analysis of the principal investigators of NIAID grants

2 This security risk assessment is valid for three years and subject to CDC or APHIS termination. The act also requires the Secretary of Health and Human Services to maintain a national database of individuals and the select agents to which they have access. 3 Changes in NIH funding and priorities have led to the construction of a series of National Biocontainment Laboratories built to Biosafety Level 4 standards, together with nine Regional Biocontainment Laboratories with Biosafety Level 3 facilities. NIAID has also funded eight Regional Centres of Excellence for Biodefense and Emerging Infectious Diseases Research (Fauci 2005).

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awarded between 2001 and 2005 to study the six priority biodefence pathogens suggests that 97 per cent of them are new to the field (Schwellenback 2005). The assertion that non-state actors are developing self-governance measures in the absence of state centric controls or because such state centric controls are declining is also questionable in relation to biosecurity controls. For example, recent self-governance measures seem to have been proposed by the scientific community precisely because state based controls are expanding (McLeish 2004). Suggestions to change the process of peer review in the publication process of certain pieces of scientific literature seem to have happened after a White House proposal that journal editors not publish ‘sections of articles that give experimental details researchers from other labs would need to replicate the claimed results’ to create biological weapons (Broad 2002). Similarly, the publication of three papers4 in 2001–2002 were widely interpreted as ‘publishing a blueprint’ for the development of new biological weapons and led to public calls for changes to research practice and scientific publication (Cozzavelli 2003; Malakoff 2003; Danchin 2002; Finkel 2001).5 In response to this threatened expansion of state power 34 journal editors, including the editors of Science, Cell and Nature, issued preliminary suggestions for a selfgoverning framework to be applied during the peer review process (Journal Editors and Authors Group 2003). In a commentary published in Nature explaining this move the editors stated: Scientists and their journals should consider the appropriate level and design of processes to accomplish effective review of papers that raise such security issues … We recognise that on occasion an editor may conclude that the potential harm of publication outweighs the potential societal benefits. Under such circumstances the paper should be modified or not published.

An expert panel set up by the National Research Council of the US National Academies produced a report, Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma (2004), recommending a prepublication review of the content of scientific manuscripts for security sensitive information. It would appear that rather than self-regulation emerging to fill 4 On the synthesis of polio virus cDNA without a natural template by Cello et al. (2002); another providing information on how the variola virus (smallpox) can evade the immune system by Rosengard et al. (2002); and a third on how to overcome genetic resistance to mouse-pox by Jackson et al. (2001). 5 See for example, Representative Dave Weldon (R-FL) House Resolution 514, in response to the publication of the polio synthesis paper in Science. (26 July 2002 House of Representatives, 107th Congress). However, the Fink Report noted that this method had been in principle available since 1981, was extremely laborious, and was scientifically interesting precisely because of the weakened pathogenicity compared to the wild-type virus (NRC 2004, 22).


the vacuum left by the emergence of a neoliberal night-watchman state, these forms of self-regulation are emerging in response to a substantial re-assertion of state power. Rather than a shift towards markets and the deregulated free movement of people, goods and materials, recent changes in biosecurity have generated an increase in regulation, and controls on the free movement of people, goods and materials. For example, vetting schemes for students operate in both the UK and the USA. The scheme in the UK which began in 1994 was introduced after it became apparent that a number of state proliferators had used the UK to train their scientists. The scheme is administered by the Foreign and Commonwealth Office (FCO) and applies to postgraduate students and postdoctoral researchers from certain countries and covers those scientific disciplines relevant to weapons of mass destruction technologies or the missiles to deliver them. Under the scheme universities and higher education colleges are able, on a voluntary basis, to seek advice from the government about whether an application from a potential student from a listed country who is seeking to undertake research in particular disciplines should be regarded as a proliferation concern.6 Recent changes to the scheme in the UK involve a shift from voluntary self-governance towards compulsory controls. In the USA a similar system, concerning entry procedures for all foreign visitors including students, was established in 1996 by the Illegal Immigration Reform and Immigrant Responsibility Act, extended by the Patriot Act, in 2001, and the Enhanced Border Security and Visa Entry Reform Act of 2002. Section 416 of the Patriot Act required the Attorney General to implement fully the foreign student visa-monitoring programme established by the Illegal Immigration Reform and Immigrant Responsibility Act (1996) and expand the programme to include other approved educational institutions such as flight schools, language training schools, and vocational schools. Section 501 of the Enhanced Border Security and Visa Entry Reform Act 2002 establishes a Foreign Student Monitoring Program which empowers officials to maintain up-to-date information on foreign students and exchange visitors in the US. Recent increased concerns about biosecurity have also led to attempts to govern the transfer of information and modify scientists’ traditional freedom to disseminate results. Again this shift is in the opposite direction to that suggested by the globalization theorists. In the United States the existing balance between national security and freedom to publish was established in National Security Decision Directive 189, issued by former President Ronald Reagan 6 The FCO lists 10 countries of concern – Cuba, India, Egypt, Iran, Iraq, Libya, Israel, North Korea, Pakistan and Syria – and 21 academic disciplines of concern including chemistry, biology, physics (including nuclear), mathematics, computing science and mechanical chemical and control engineering. According to information released under the Freedom of Information Act (2005) the numbers of referrals has grown from four in 1998 to a peak of 740 in 2002.

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in 1985 and reaffirmed by National Security Advisor Condoleezza Rice in November 2001. This directive guaranteed that there would be ‘no restrictions … upon the conduct or reporting of federally-funded fundamental research that has not received national security classification’ (USA 1985). Shortly after this reaffirmation the term ‘sensitive but unclassified’ became vogue as a means of preserving confidentiality without formal classification. In January 2002, as part of the effort to safeguard ‘sensitive but unclassified’ information, more than 6,500 declassified documents relating to sensitive chemical and biological warfare information began to be withdrawn from public access (McLeish and Nightingale 2007). Similarly, there has recently been a re-emergence of state centric security measures covering the transfers of dual use technologies. The rise of the ‘proliferation-terrorism nexus’ (Ellis 2003) has caused states to implement national and international policy solutions such as the Proliferation Security Initiative (PSI).7 PSI involves the interception of technology shipments, typically at sea, from proliferating states and aims to address the approximately 40 states that are not yet signatories of the BWC and are not yet obliged to have national laws in place that implement the BWC prohibitions. Similarly, UN Security Council Resolution 1540 (2004) obligates all UN member states to refrain from providing any form of support to non-state actors attempting to acquire, use or transfer WMD and their delivery systems, and that in accordance: their national procedures, shall adopt and enforce appropriate effective laws which prohibit any non-State actor to manufacture, acquire, possess, develop, transport, transfer or use nuclear, chemical or biological weapons and their means of delivery, in particular for terrorist purposes. (See UN 2004; Oosthuizen and Wilmshurst 2004; Kellman 2004)

Taken together these changes in biosecurity policy suggest that, rather than a reduction in traditional hard security and an incorporation of ‘new security challenges’, we have seen an expansion of hard security as nation states expand the scope of coercive control and implement new security legislation. This fits more closely with Rosenberg’s (2001) critiques of globalization theory or Abrahamsen and Williams’ (2006) argument that the privatization of local security should not be understood as part of a ‘retreat of the state’ but as a new configuration of state power that is misunderstood if seen in the light of too stringent a distinction between the state and society. In the next section we build on Rosenberg’s critique and apply it to the governance of biological weapons. 7 This was launched in 2004, is supported by over 60 countries and aims to counter the development of WMD by all non-state actors (such as terrorists) and states of concern, together with those who supply such programmes through trafficking in sensitive materials, equipment and technology (Byers 2004; Joyner 2004).


The Eschatology of Social Theory Simply pointing out that many of the empirical features of the new biosecurity governance regime are at odds with theoretical predictions is not in itself a particularly pressing problem for proponents of globalization. It can simply be dismissed as an anomaly. What is needed is a more convincing explanation. Rosenberg’s (2001) suggestion is that there is nothing for globalization theory to explain as the phenomena we see fit perfectly well with classical social theory. His point is that modern state sovereignty – internal political primacy and external political equality (Rosenberg 2005, 19) – with politics a self-contained realm of activity are consequences of how we organize our economic lives. Throughout most of history economic production and distribution of wealth have been organized through complex hierarchies of political economy (ibid., 19–20). But today the mode of wealth creation involves ‘contractual relations of exchange among people who are legally and politically equal’ (ibid., 20) and hence requires the formation of civil society, distinct from the state. This in turn required the withdrawal of the state and its reconstitution as the provider of conditions where the private sphere can flourish, through for example, the enforcement of contracts and the provision of security, broadly defined. As such, the notion that the state might hollow out and cede sovereignty both above and below, shifting towards governance rather than government, can be misleading. The co-existence of state sovereignty with expanding global inter-connectedness is entirely consistent with, and at the extreme may even be a precondition of the global expansion of trade; as might a reassertion of state sovereignty and power and its execution through new non-state actors. If governments decide that self-regulation below and international arrangements above are the best way of providing security then they can use them. Similarly, if they think that another structure is more appropriate then it is hard to see how social theory will get in the way. What appears to be a shift from government to governance, can easily be understood as its opposite: namely a retreat from international agreements (Pearson et al. 2001) and security through transparency (Walker 2003), a reconfiguration of security at the state level and then its varied imposition which is producing changes to pre-existing forms of regulation from below. Rosenberg’s assertion that globalization theorists are ideological amplifiers of the Zeitgeist rather than its interpreters (Rosenberg 2005, 7) seems harsh, but may not be unfair. The extent of the limits to governance based approaches can be understood by exploring the knowledge claims of globalization theorists in the light of Beck’s (1992) assertion that social changes are driving a change in risk assessment and risk management from a concern with knowing risks, to a concern with the risks associated with ways of knowing.

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Beck and the Emergence of a Risk Society Beck’s assertion that modernization brings its own, non-natural kinds of risks, is not (as often supposed) his major contribution, (it was, for example, a central feature of research from the nineteenth century). Instead, Beck is asserting that risk management is becoming self reflexive and that established ways of dealing with risk, particularly in relation to scientific knowledge and calculations of threats from external (natural) dangers, are collapsing in favour of addressing risks associated with decisions. In the previous world of risk management, scientific knowledge played a key role and expertise of natural risks, and therefore the subject matter of natural sciences, was central. Within the new risk society, on the other hand, scientists are not innocent, as many of the risks society faces are dependent on, or even produced by, scientific knowledge. Industrial pollution for example, is not natural, but is rather the result of artificial processes made possible by scientific knowledge. The complexity of the choices that generate these risks means that their production is something that traditional claims to expertise (in the natural sciences) do not convincingly cover. As a result, the dominance of scientific expertise is over and with it the distinction between expert and non-expert and the previous de-politicized nature of risk management. The new politicized nature of risk and risk management is however, Beck highlights, often hidden in new institutions that exist to normalize and manage risks, and through the use of cosmetic procedures to make them acceptable. However, Beck is not all doom and gloom. He highlights that the new risks society faces are very democratic, in the sense that the risks of poverty in an industrial age hurt the poor, but the risks of pollution, endocrine disruption and nuclear reactors melting-down harm everyone regardless of social class, and fail to respect international boundaries. As a consequence, he argues there is potential for a new (globalized) democratic politics of risk involving a new reflexive science, in which, surprisingly science becomes more important as its monopoly on expertise is broken and it becomes more diffused through society to be involved with the public in the co-production of truth. Beck therefore provides a very insightful, and coherent, interpretation of changes in risk management practices that have a range of implications that might usefully be explored. The connection between modernization, industrialization and the emergence of new forms of risk and risk management is obviously more subtle and nuanced than this short summary can illustrate. Questions can, of course, be raised about the extent to which Beck’s thesis is bound in space and time. While his ideas clearly sit well with German academics concerned with environmental policy, influenced by Habermas and working within a federalized political system, it is not clear how well they would sit in Iceland or Iran. Similarly, while his assertion (Beck 1992, 2) that society went from feudalism to capitalism in the nineteenth century is surely a misprint or mistranslation,


his assertion of the emergence of a risk society involves substantial historical claims about what existed before and what is emerging now. This is particularly the case in relation to the historical validity of claims about natural versus created risks that address events, categorization and understanding. Moreover, there does not seem to be any ground for privileging a sociological theory over history. From a historical perspective Beck is not only making claims about history, he is engaged, like other proponents of globalization theory, in Eschatology. As such, the Risk Society is constructing a ‘past’ that can then be used to justify changes and political power within the present (see Plumb 1969). Seen in this light, Beck’s claim about the end of expertise and the democratization of science seems slightly suspicious. It is not a displacement of expertise, but the implicit assertion that a new form of expertise is needed – namely that of the social scientist who understands the social processes of risk formulation and management, and understands them better than the previous experts – namely scientists. While clearly this could amount to a self-serving claim that is not in itself grounds for dismissing it. Indeed, it is hard to think of many areas of contemporary risk management where a solid training in sociology would not be valuable. Beck is surely right to stress its importance – the issue is whether sociological expertise is a complement to scientific knowledge or its replacement. Biosecurity Controls as Risk Management At first sight biosecurity controls would again seem to be consistent with Beck’s thesis about the emergence of a risk society. The growth of the biological sciences, particularly in the US since the 1970s, has been part of an explicit traditional risk management exercise (for example, the expansion of research following ‘The War on Cancer’). The point of the federal investment, rhetorically at least, has been the intention to develop increased scientific expertise to address natural risks. This expertise was generated through biological studies of naturally occurring infectious diseases, medical studies of pathogen action, and epidemiological studies at the societal level. In all cases the knowledge produced feeds into risk appraisal in which scientists play a key role as experts. With the emergence of biological weapons as a major policy issue, concerns are directed to both naturally occurring inputs to weapons development programmes (i.e. pathogens), but also to scientific knowledge itself being dangerous when misapplied. The existence of scientific knowledge about immunology and infectious diseases, etc., becomes part of the problem rather than part of the solution to a naturally occurring problem. This would seem to be an almost text-book case of a shift from the problem of understanding (natural) risks to the problem of risks from ways of understanding.

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Beck’s thesis is not only about the context of knowledge, but more interestingly, about the organization and norms of the social structures of knowledge production. In this instance, again, the problems posed by biosecurity would seem to fit his thesis. In particular, the continuing Mertonian norm of openness, while fine when addressing natural risks from pathogens, becomes a problem when that knowledge might be misapplied. For example, the publication of the papers on the synthesis of polio virus cDNA, variola virus immune evasion and overcoming resistance to mousepox noted previously were widely interpreted as increasing risks and led to calls for changes to research and publication practices. Similarly, the increasing recognition of the potential for misuse, as highlighted in the Editors’ statement and various publications and reports produced by learned societies, has no doubt generated a significant degree of self-reflection on both the organization and norms of biological knowledge production. Again, recent changes in risk management would appear to validate Beck’s assertions that this is producing new sites for the calculation of risk within society that are beyond the traditional remit of the security expert. Moreover, these would seem to be far more open, in the democratic sense, and also reflective of a deeper shift in risk management from scientific expertise (see for example, Royal Society 1992). What was previously seen as natural or fate, now becomes the result of a series of institutional choices, that invite blame, and therefore need to be managed, but are subject to competing visions of how this should be done. The huge expansion of biosecurity related research and the formation of institutional bureaucracies that are prepared to deal with bioterrorist attacks could similarly be seen as both new sites of risk management or in Beck’s insightful phrase examples of ‘institutionalized non-management of problems’ that are designed to manufacture comfort at the expense of addressing real problems. This opening up of security policy to expand into science policy, and in doing so, incorporate new actors could be seen as an consequence of the democratic nature of the ‘social distribution of risk’ for these modern risks – the risks from natural outbreaks of infectious disease are socially stratified but the threat from biological weapons now encompasses everyone, as is often asserted, we are all at risk from bioterrorism. It would seem then, that biosecurity is a ‘new security challenge’ that emerges from a nexus of an emerging risk society, and its devolved governance procedures are expressions of both the democratization of risk and expertise to create new centres where knowledge production itself becomes self-reflexive. However, on closer examination the fit between theory and evidence becomes less clear. For example, the distinction between old, natural and new, manufactured risks while clearly useful when looking at air-crashes does not seem so simple when looking at pathogens that have co-evolved with us for


millennia.8 The sorts of weapons described by Alibek, even if exaggerated, are clearly a huge cause for concern, but a close connection between biological sciences and weapons production is not in itself something new (Guillemin 2005; Fraser and Dando 2001; Leitenberg 2005). Nor for that matter are reflexive concerns about the misapplication of scientific knowledge, a point highlighted by Bacon in 1609, who recognized its dependence on the social and organizational forms in which knowledge production takes place, and sought to address those in his New Atlantis. Reflexivity about the context and organization of science in relation to security is a pre-modern rather than post-modern phenomenon. Nor is it entirely clear that Beck’s transformation of risk has actually taken place, as it is largely dependent on a Nature/Society distinction that is questionable.9 Moreover, discussion of scientific decision-making with respect to risk, carries with it an implicit assertion that ‘scientific’ decisionmaking is one thing, presupposing a unity of science that is not there (Dupré 1996; 2001). As Dupré points out, science is a ‘motley collection’ of different practices, which differ widely in their methods, results and robustness (1996). The implicit assumption that science is a unified thing then creates the false choice between accepting or rejecting science. However, there is nothing to prevent one making value judgements about the diverse methods of science and giving more credence to some fields (immunology, molecular biology) while dismissing others (evolutionary psychology) (Dupré 2001). Once one accepts that there is variety across scientific fields, within disciplines, through history and in different places in the quality of truth claims, then the simple shift from a) scientific to b) risk society forms of knowledge creation seems unhelpful. Moreover, the assertion that traditional risk management was ‘scientific’ becomes a historical assertion rather than something that is true by definition. As such, it is questionable, because the model of decision-making in ‘traditional’ risk management is not how decisions actually take place (Searle 2001; Hopkins and Nightingale 2006). In particular, in relation to security policy, the uncertainties of policy making, particularly in relation to future developments in technology have been an explicit part of policy making. For example, the General Purpose Criteria within the BWC addresses purposes 8 The complex relationships between pathogens and people at both the immunological and society levels and their role in human history suggests the distinction between natural and manufactured is one of degree rather than kind. 9 If we compare the situation today with that of 50 years ago, it would seem the world is moving in the opposite direction to the one posed by Beck. Back then the world was at risk from very substantial biological weapons and new antibiotics were providing a shield against infectious disease. Today, those weapons are outlawed by a very successful international treaty, and we are now subject to increased levels of antibiotic resistance.

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not things to ensure the treaty does not get overtaken by future developments in technology thereby codifying the treaty in a timeless form. This was crafted by diplomats rather than scientists. Consequently, within this domain, the Risk Society picture of science and scientific expertise is misleading. This is particularly the case within security where there are so many unknowns, and where assessment of risks that relate to human intentions and capabilities rather than natural phenomena has been going on for centuries. The scientific expert of the Risk Society is not an accurate description of who developed risk policies in this case. Nor is it entirely clear that the norms and organizational structures of the biosciences constitute, or rather are constitutive, of risks. There is no doubt that there is a perception of threat and the life sciences have been recast as threats, leading to a range of policies that address that threat (NRC 2004; Gaudioso and Salerno 2004; Atlas 2002). MacKenzie and Spinardi (1996) suggest for example, that the information passed in scientific and technical publications does not carry with it the tacit knowledge needed to turn theory into practice. Similarly, what seems to be self-reflection cannot be taken at face value. In interviews with UK scientists working with dangerous pathogens, and subject to new security legislation, it was clear that they were extremely reflexive. Following Stirling’s (2000) distinction between unreflective, reflective and reflexive approaches to risk management, none of the scientists we interviewed took an unreflective approach.10 This contrasts with the picture of the scientific community in large parts of the risk literature that sees scientists as largely concerned with instrumental issues. In interviews, the scientists regularly reflected on the unintended consequences of different policies. For example, they highlighted the difficulties involved in constraining the flow of information at publication stage because the research would have already been publicized at conferences.11 They were reflexive in their understanding of policy options and understood policies could be effective for unintended reasons (for example, substantially more considered editorial scrutiny of papers at publication a good idea, than believed it would reduce the risks of misuse). Similarly, we did not encounter any attempt to quantify risks. Instead, we found emphasis on processes that 10 Unreflectiveness only takes into consideration instrumentally pertinent attributes when adopting risk management approaches, reflection, takes intended and unintended consequences into consideration, and reflexivity, considers the subjective and normative assumptions behind interventions (Stirling 2000). 11 Similarly, 61 per cent of our sample population thought that denying access to nationals from countries of concern would not reduce the risk. As well as a philosophical dislike of denying access on the basis of nationality, it was called to our attention that universities in the UK are actively encouraged to accept foreign student applications – some of whom are nationals from the ‘countries of concern’.


successfully manage and reduce unknown risks.12 We found that scientists expend considerable effort in engaging with the wider community to generate and maintain socially robust knowledge. The scientists we interviewed went beyond an unreflective belief that risk analyses were flawed and should be dismissed, and beyond a reflective recognition that their analysis of risks might also be flawed, to recognize that there were a range of different perspectives and normative positions which would and should influence policy construction and implementation in a democratic society. Finally, what seems like self-reflection and the creation of new localized sites of risk calculation in response to the emergence of, or shift towards, a risk society, turns out to have another, slightly less grandiose explanation. Scientific activity in the UK has been heavily regulated since the 1970s through successive health and safety measures. The 1974 Health and Safety at Work Act, for example: [I]ntroduced a broad goal setting, non-prescriptive model, based on the view that ‘those that create risk are best placed to manage it’. In place of existing detailed and prescriptive industry regulations, it created a flexible system whereby regulations express goals and principles, and are supported by codes of practice and guidance. Based on consultation and engagement, the new regime was designed to deliver a proportionate, targeted and riskbased approach. (HSE 2004)

That flexible system had created procedures to deal with the acquisition of dangerous material, access to laboratories and data by visitors and shortterm workers, and the transfer of dangerous materials. Although biosafety and biosecurity are fundamentally different – biosafety being concerned with protecting the health and safety of workers and the environment whilst the central concern of biosecurity is unauthorized acquisition – the norms are compatible and the implementation of biosecurity measures has drawn heavily on the biosafety model. It should be noted that the importance of self-reflection and the diffusion of decision-making down to those who create it, based on the superiority of local decision-making (i.e. ‘those that create risks are best placed to manage them’) occurred well before the 1990s. The new biosecurity legislation introduced in the UK concentrated on tightening already existing practices and has not introduced radically new requirements. 12 This might explain the support for the Health and Safety Executive as the preferred medium by which government should enact regulations: this is a department with which the scientific community has a long established working relationship, and an approach which would allow the scientific community to be more involved in the policy making process where it could exploit its local knowledge and assist in the creation of more effective policy.

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It could be argued that the operational changes experienced by our sample since 2001 might have occurred as a result of commonplace periodic reviews of biosafety, rather than as a direct result of the introduction of new biosecurity obligations. An Assessment: Biosecurity, Governance and New Security Challenges The changes in biosecurity policy and its increasing interaction with science policy outlined in this chapter highlight the limits of ‘governance’ as a theoretical concept. It is certainly true that recent changes in biosecurity policy can be easily fitted into a governance framework, but more detailed analysis highlights both major anomalies and more convincing explanations. While the implementation of new biosecurity measures has involved a degree of self-regulation this does not amount to a shift away from the state to public participation in governance. The threat assessment that was used to inform the risk assessment was centralized and received little input from the scientific community or public at large in the UK. Clearly, security is an area where even when risks are democratically distributed it is not necessarily the case that information about those risks should be as well. In the case of dual use knowledge, part of the risk strategy is to prevent the diffusion of that knowledge, suggesting that in this arena at least, any hopes for a new globalized civil society response is wishful thinking. If recent changes in biosecurity sit uneasily as a shift from government to governance, how well do they fit as a shift towards a risk society? There can be no doubt that Beck has made an impressive and important contribution to our understanding of changing patterns of risk and risk management within contemporary UK society that provide provocative ways of exploring complex phenomena. As with globalization theory’s assertions of the demise of state power and its diffusion above and below, biosecurity is a small and atypical area that can be dismissed as an irrelevance. However, the fact that it is an area where science is the receiver rather than the producer of regulation generated by external experts, highlights the problematic nature of any equation of expertise with science, and in particular any monolithic treatment of science. Once one sees that science is not the unified thing needed by the governance approach, then assertions that science had a monopoly on risk analysis before, and that science has now lost its monopoly looks unconvincing. A more likely scenario is that various parts of science along with various other types of knowledge production played a role in risk management in the past, and still do so today.13 As we have highlighted, 13 What is presented as ‘scientific’ or ‘sound science’ is little more than political choices, incorporating a range of normative framing assumptions, dressed up in the borrowed legitimacy of science (Stirling 2000).


biosafety officials in the UK have played a vital role in managing the risks associated with biosecurity. More importantly, and more generally, Power (1999) notes, auditors rather than scientists have been the main risk managers in recent years. And as Bacon highlighted, the risks associated with ways of knowing and their links to the norms and organization of science were well known in the seventeenth century, and, as has been already noted formed the basis for the plan for New Atlantis. It is hard then not to suggest that Beck’s transformation is misleading as a historical assertion. Beck’s stress on the increasing importance of manufactured risks, and the way in which they are generated by structures of knowledge, determined by choice rather than fate, and therefore require management and generate new risk management structures within society, is very insightful and timely. As is his critique of contemporary risk management institutions ability to manufacture comfort rather than address real issues. Power (1999) has highlighted the key role that audit plays within this risk management process, and defines audit in terms of the second order ‘control of control’. This second order risk management produces an ‘expectation gap’: for example, external financial auditors in firms do not go in and detect fraud, they go in and give a professional opinion that the procedures in place within the firm to detect fraud are valid. Power’s criticism of the growth of audit, is that while it is much cheaper than actually investigating the problem (detecting fraud, improving environmental performance, etc.), being a second order form of control, it does not really address it. Moreover, through the false legitimization it provides, it creates the potential for audit feedback, in which a failure in a system leads to calls for more audit, even when that failure was caused by audit itself. We would suggest that the governance approach and Beck’s dichotomy between old (scientific monopoly on expertise) and new (risk society’s democratization of expertise) forms of risk management ends up functioning as audit when combined with a refusal to inquire into technology and technical risks, because they both end up taking risks at face value. Hedgecoe and Martin (2003) have argued that this methodological refusal to engage with the substance of science and scientific risks within the genomics area has led to a wide range of important and insightful social science, that addresses phenomena that do not exit (see Nightingale and Martin 2004 on the Myth of the Biotech Revolution). By legitimizing social science approaches that do not inquire into the substance of claims of benefits or risks first-order control is abandoned and governance as audit takes over. Power’s work suggests that the resulting failures are likely to be met with calls for more audit which in this case would be a shift further to governance. If this happens it is hard to see how claims to be opening up risk management can be sustained. If all such frameworks are doing is providing what Pentland (1993) calls ‘symbols of comfort for anxious rulers’, then there is a risk that they will get in the way of effective risk management.

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Chapter 7

Biosciences, ‘Development’ and the Abstraction of Governance James Smith

Introduction In a recent book, Robert Paarlberg, argues that developing countries are not being allowed to make their ‘own’ decision regarding their use of genetically modified crops (Paarlberg 2008). He describes how pressure groups and lobbyists – mainly from Europe – are turning the heads of African leaders and influencing them not to accept the potential of biotechnology. Aside from the obvious issue that Paarlberg is doing the same thing from a different perspective, implicit in his argument is the notion African leaders when confronted with evidence are unable to make the most appropriate decisions for themselves. At first glance this may seem slightly disparaging or even neocolonial but if one explores the context in which most African, and other developing country, governments must make decisions, prioritize and implement policy it is apparent that a series of structural processes have stripped away options and decision-making ability. New and emerging technologies such as biotechnology, and the calculus of risk and benefit embedded in them, further underlines pressures on ‘governance’. ‘Governance’ is a term that resonates around all discussion of new and emerging technologies on the one hand and ‘development’ on the other. This is perhaps unsurprising: the frontiers of technological innovation advance rapidly, new, unfamiliar technologies emerge from unexpected sources, and despite massive increases in development assistance and greater coordination, extreme poverty remains as intractable as ever. How we conceive governance in these contexts is markedly different. Chapter 1 outlined a shift from ‘government’ to ‘governance’, a move away from the statist control of increasingly global, complex and transnational issues – emerging technologies amongst them – towards a networked, inclusive system that could encompass multiple viewpoints and perspectives. Governance in this context quite often remains an abstract idea, something of an ideal. Governance in the context of development means something quite different however. It is fundamentally concerned with the state, good or bad. Governance as a developmental construct is not an end point or the identification of a transformation in decision-making, but is more often than not a whip to

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be cracked. Governance has become the central concern of development; development assistance is predicated by conditions of governance, economic growth is tied to good governance and bad governance is invariably a cocontributor, real or imaginary, to the failures of development. The publication of the World Bank’s Berg Report in 1981 broadened our definitions of growth and development to include governance as a cornerstone of development (World Bank 1981). Developmental governance, then, has become a value, something to which both success and failure may be attributed. Despite the fact that development is increasingly manifested in terms of Millennium Development Goals, coordination and harmonization governance remains firmly centred on the state. This dichotomy presents a problem when thinking about the relationships between technology and development. Technologies, in their complexity and uncertainty, have presented challenges that have led us to think about their management in new ways, or have presented unforeseen problems that have prompted us to think about what may have gone wrong in the past and how it might be avoided in future. The stories of technologies are littered with retrospective imaginings of what ought to have happened. Development, as a global process that remains relatively little questioned, is contrasted by its own lack of history and retrospect (Smith 2009). Development is conceptualized as a grand narrative, a journey and a destination, and when it is forced off course the blame more often than not falls not on the process or the system, nor on the fields of knowledge that underpin it, but on the ‘state’; the apparent core of decision-making. This chapter argues that it is mistaken to think of the governance of technology for development in terms of the state. The state may be perceived as the locus of the failures of development but the state in developing countries is more often than not in a position to affect change, make decisions or deal with complex entities such as new and emerging technologies. Development is not a process but a complex assemblage of decision-making: as the case studies in this chapter illustrate the state is quite often entirely absent. The chapter argues that this does not necessarily mean that the thesis that governments will inevitably be replaced by new modes of governance in the face of complexity, uncertainty and risk is correct. Rather, it argues that governance in the context of the biosciences in developing countries is an abstraction, both abstract in conceptualization and abstracted from the sites in which bioscience (in terms of research, development, innovation, adoption, impact and evaluation) as a performance is played out. Governance is simultaneously distanced from the state whilst the state is increasingly tasked with dealing with complex ideas and technologies. Governance is concurrently abstracted out of countries whilst governance becomes an abstract concept of blame and inability to make decisions. This is particularly true in relation to technologies borne out of the biosciences, which by their very nature are complex and embedded in systems that inevitably lie outside the wit of any single state to deal with, let

Biosciences, ‘Development’ and the Abstraction of Governance

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alone states beset with the problems of poverty, lack of resources and limited capacity and options that often characterize the poorest countries in the less developed world. The Shifting Context of Science Policy in Development Countries It is important to sketch out the context in which science and technology has evolved in developing countries. This intersection of uncertain and unstable institutional factors, new thinking regarding how science ought to relate to development, and indeed changes wrought by new technologies themselves allows us to map out a topography in which we fundamentally need to rethink what we mean by ‘governance’ in relation to technology in the context of poverty. A key factor, inferred above, is changing macroeconomic approaches to governance. The nature and ambit of the state has rapidly changed in developing countries, particularly those most influenced by external donors, and those most in debt. Economic decline in the 1970s, structural adjustment programmes and latterly poverty reductions strategy programmes have led to the retreat of the developing-country state. Through policy and loss of income the state has increasingly withdrawn from controlling the economy, with the role of the state shifting from implementation towards enabling appropriate macroeconomic policies. Central to this is the move towards allowing the market to provide services and to use competition to generate efficiencies that the public sector arguably cannot achieve. The ‘adjustment’ in structural adjustment referred to macroeconomic and trade policy reforms (such as exchange rate reform, for example) but also had to do with changes in the structure of the economy, mainly the extent to which the state provided public services and controlled key economic sectors. The approach was an attempt to reduce large and apparently unproductive, public sector bureaucracies, to break up state monopolies and to open up markets to competition, both nationally and internationally (Stiglitz 2003). As a result universities, research institutes and agricultural research systems began to face new challenges particularly with respect to funding and support. This had further implications in, for example, the ability of developing countries to provide adequate extension systems for new technologies (Pardey et al. 1997). Traditionally the job of passing on the results of research was given to state-funded extension services. Extension systems have clearly suffered under the contraction of the state, but this ‘transfer of technology’ approach has been increasingly criticized for its inability to articulate end users’ needs (Hall et al. 2004). Uganda and Bolivia, for example, have partially privatized their extension services. New organizations, such as non-governmental organizations, have replaced some of the defunct activities of the state as Harsh shows in Chapter 10 of this volume.

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Related to the contraction of the state is the emergence of private sector research. Whilst this is partly simply relative, new intellectual property regimes and public sector support has led to the emergence of new forms of research partnership. Public-private partnerships in developing countries have taken on much of the development of agricultural biotechnologies, for example. These complex partnerships, which quite often exist outside the orbit of the developing-country state as the ‘public’ sector component is often international in nature, have transformed the institutional context in which bioscientific research is undertaken in developing countries (Clark et al. 2007). Often what is the ‘public’ and what is the ‘private’ is increasingly confused. The International Aids Vaccine Initiative, for example, demonstrates how public sector funding can stimulate private sector research and innovation in situations where markets cannot (Chataway and Smith 2006). The state is, through these processes, losing control of research policy and research agendas in several different dimensions. These institutional changes are thrown into sharper relief when one considers that often technological development has not led to discernible impacts on poverty. While the Green Revolution’s initial impact on aggregate yields of maize, wheat and rice was impressive in the aggregate and longer term the evidence of poverty alleviation is much less clear with the most impressive yield increases and subsequent livelihoods improvements accruing to better resourced farmers (Conway 1997). Green Revolution technology tended to require high levels of ancillary inputs such as water and fertilizer, and supportive institutional structures dealing with extension, credit and marketing. Richer farmers had access to these but poor farmers relied heavily on state support such as subsidies for key inputs like fertilizers. Such support was forthcoming in the 1970s but, as global financial crises impinged in the 1980s, this began to vanish. Biggs (1990) has drawn attention to the key institutional dimensions of the inequalities of the Green Revolution and, specifically, the hierarchies inherent in research systems fashioned on the ‘linear’ model of innovation, from research institute to extension system to farmer. There is an increasing realization that new, more responsive institutional arrangements are needed in order to develop bioscientific technologies that more accurately reflect the needs of farmers, the poor and other end users. The patchy and disappointing impacts of linear, public-sector research has led to shifts in the way donors fund research in developing countries. Donors, who increasingly drive research in developing countries, are no longer willing to fund research that does not demonstrate operational linkages to technological application and to the poorest sections of society. Donors are acknowledging that science policy must be nuanced enough to recognize the contexts in which research must take place and help build the networks needed to link together actors to ensure technologies reach their intended populations. This has been a slow process but increasingly science and technology is being recognized


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as but one component of a systemic approach to innovation in developing countries (Clark et al. 2007). Finally and possibly most importantly in the context of this volume new technologies in themselves shape the context in which they are developed, exist and impact upon society. The biosciences, and biotechnological innovations in particular, manifest new risks and opportunities and as other chapters in this volume describe interact with society and its institutions in many ways (Clark et al. 2002). In sketching out the context of developing countries we can see the multiple dynamics and processes that interact to alter the role of the state in promoting research, shaping policy and deriving and prompting maximum benefit from technological innovations. In many respects each of these dynamics serves to strip the capacity of the state to govern, either explicitly or relatively in the case of new technologies. The state has retreated as donor funding into bioscientific research has increased. The state has also shed its capacity to conduct its own research just as new transformational forms of biotechnologies, for example, threaten to change environments, value chains and food systems. This technological ‘double movement’, to paraphrase Karl Polanyi (1944), has served to strip governance out of the developing country state. ‘Governance’ has been concretely abstracted away, and ‘governance’ in the sense in which it is conceptualized in relation to technology can be seen as an increasingly abstract term. This chapter now moves towards looking at three short case studies, the aim of which is to highlight just how far away from context governance takes place. The first case highlights the way in which bioscience research and development is organized in developing countries has retreated from the state into international institutions. The second case uses the example of food insecurity in southern Africa in 2002 to show how decisionmaking is stretched away from the state via intercontinental debates about trade and regulation. The final case presents the stalled biography of an antisleeping sickness drug to illustrate how the private sector operates completely outside of the developing-country state. These case studies or vignettes serve to delineate governance and allow us to reflect on what ‘governance’ actually means in the context of new bioscientific technologies, weakening states and multiple, complex external dynamics. ‘Isolable Problems’ and the Abstraction of Research Massive population growth in South and Southeast Asia, coupled with stagnant increases in rice production (and the threat of communism) prompted the Rockefeller and Ford Foundations to fund an international effort to ‘solve this problem of rice’ (Harrar 1958, in Anderson 1991). After some debate around how this might be best achieved the International Rice Research Institute (IRRI) was opened in Los Banõs in 1960. IRRI, together with the research programmes that would eventually coalesce into the Mexico-based CIMMYT

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(Centro Internacional de Mejoramiento de Maíz y Trigo), produced the hybrid seeds and management innovations of the Green Revolution that would culminate in the development of a network of International Agricultural Research Centres (IARCs) as the dominant model of agricultural research in the developing regions of the world, and collective, public funding of research as the prevailing mode of supporting research in search of developmental goals. IRRI and CIMMYT would form the basis and the blueprint for the Consultative Group for International Agricultural Research (CGIAR), which would become the single largest public investment into generating sciencebased solutions to the challenge of poverty eradication, with an annual budget that has expanded from an initial US$20.7 million per annum in 1971 to US$425 million per annum in 2004 (Alston et al. 2006). The idea behind the CGIAR was that massive, focused funding of research institutes with defined agendas could supplement the relatively limited capacity of developing country National Agricultural Research Systems (NARS) to undertake basic research. The CGIAR was built on a conviction in scientific knowledge and its ability to promote societal change. The IARCs were conceived of as mechanisms to drive the modernization of subsistence agricultural practices towards a market-led future: We would suggest that there are two types of activity which make sense: first, activities which explicitly face up to the complex and interrelated problems of ignorance and tradition, and to seek to attack those problems; and second isolable technical problems which are so important that their solution would find acceptance and application even under present circumstance.s (Harrar et al. 1952, 25–6, in Anderson 1991)

The premise behind the Green Revolution was simple; to develop a series of conventionally bred rice, wheat and other cereal varieties designed to respond well to artificial fertilizer. These high-yielding crop varieties were initially bred in IRRI and CIMMYT. The focus of researchers was straightforward, to breed varieties that responded well to inputs and release them to farmers. There was much talk at the time of eliminating hunger and poverty at a ‘stroke’ (Cleaver 1972). Green Revolution technologies, packages of improved seeds, increased fertilizer and extensive irrigation, initially had a dramatic impact on agriculture. Between 1961–1985 cereal production in developing countries doubled. However, the poorest farmers in Asia, and more particularly in Africa, did not have the resources to adopt the entire package of these technologies. Increased yields were almost exclusively concentrated in the fields of those wealthy enough to exploit the technologies (Conway 1997). More recently much debate has centred on the impacts of this model of agricultural research and the Green Revolution on the environment as massive amounts of fertilizers were pumped into sensitive ecosystems, on social structures as


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inequalities intensified and on indigenous agricultural systems as farmers were effectively deskilled and steered towards generic modes of crop production (Glaeser 1987). While research at IRRI has diversified over time there was initially scant regard to contextual issues of rice production: Rice research should be ‘truly internationalised’; differences of language, culture, race, creed, colour and tradition ‘must be rendered unimportant’. Rendering these differences unimportant, presumably in some central place and by some external and power agency, would be the only way to ‘develop broad plans for long-range agricultural problems’. (Anderson 1991, 73)

IRRI had a singular mission; to develop varieties of rice that would yield several times what current varieties did (Chandler 1992). Scientists in the United States had achieved this over the previous 50 years, and there was confidence that applying similar techniques and approaches in Asia would yield the same results. The focus was on intensification and modernization of production, and a focus on areas where intensive, mechanized, irrigated rice production already took place. Embedded in this approach was a belief that one centre could work independently of geographic, political and cultural diversity; that research and the development of new rice varieties could be centralized and then disseminated. ‘Internationalizing rice research’ actually means centralizing and decontextualizing it. IRRI was to study and seek solutions for only certain parameters of rice production, and it would do so in relative isolation. The conceptualization of the new rice research institute as an ‘international’ centre for rice research was also a conceptualization of rice research – of research – as a supranational enterprise, devoid of a focus on national and local issues of context and dissemination. There was a certainty in the power of research and the linearity of research impact. Any kink in linear flows of new technologies would be due to ‘ignorance’ and ‘tradition’, not the misapplication of scientific solutions to technical problems. Focusing on the isolable problem of rice yields in field plots in Los Banõs isolated research from the contexts of rice production, consumption and dissemination of technologies. Rather, it would fall to states’ own National Agricultural Research Systems (NARS) to actively disseminate new seed technologies to farmers. In this way dissemination, and communication with farmers, was devolved to countries; there was no direct mechanism for IRRI to learn about the impact of its research. The impacts of IRRI’s research would also depend in part on the capacity of individual NARS to multiply rice seed, distribute it, educate farmers about its benefits and monitor impacts. The capacity of NARS to undertake these tasks varied widely. As the previous section described developing country states, particularly in Africa, have had their capacity circumscribed by external and internal factors. The capacity of NARS, of developing countries to undertake their own agricultural bioscientific research

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and monitor the impacts of other research, has declined significantly over the past couple of decades. The lack of capacity of NARS in Africa was one of the main reasons the Green Revolution had a much more limited impact in that continent. This decline in capacity was in many respects exacerbated by the existence of IRRI and its sister IARCS. They attracted and recruited the best local scientists, out-competed local research institutes in attracting grants, and received large flows of funding directly from multilateral and bilateral donors. Rather than energizing local and national research the IARCS existed almost entirely separately. This has been the case in Africa, Asia and Latin America (Chataway et al. 2007). IRRI’s early experiences in developing new varieties were somewhat disappointing, especially seen in retrospect and in the context of early hopes. The science proved problematic, its impacts and implications were revealed as more complex than initially foreseen, and the ideal of producing universally applicable high yielding varieties was reappraised by the 1970s. In addition, a set of institutional issues existed, not least of which was a lack of capacity in NARS, coupled with little interest in really engaging with the apparatus of developing-country states. IRRI’s original conceptualization of the problem was purposefully narrow and focused, but when the first generation of new varieties failed to live up to expectation, the conceptualization was revealed as too narrow and too focused. Nevertheless, IRRI and CIMMYT had an enormous impact on aggregate crop production and the idea of international centres of bioscientific research excellence neatly matched the ideals of development as an international process. The institutional model dominated and in 2008 there are currently fifteen such institutes in the CGIAR network. It would be fair to say that a law of diminishing returns is very apparent within the system and it is only relatively recently that the CGIAR has begun to re-think the role of international research centres and how they might better interact with different sets of actors. The decline in NARS across the developing world means that they are becoming increasingly peripheral in the story of international agricultural research, and this means that the already limited role of states within these research networks also continues to wither. IRRI and its sisters sit in states but exist outside of states and this has driven them to internationalize policy, priorities, capacity and impacts. While the CGIAR serves to demonstrate a global ability to cooperate and coordinate resources it underlines the disconnection of the state from these processes. In abstracting and isolating complex developmental problems to the smallest, simplest unit (yield per plant, or yield per rice paddy) biosciences research has sought to link the genetic and latterly the molecular to the international and to the global, often completely bypassing the state and its own insights, priorities and needs. Any conceptualization of governance was lost in a belief in the primacy and potential of science.


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GM Food Aid and Zambia – the Globalization of Governance? By early 2002, southern Africa was facing the worst food crisis in a decade, as some 16 million people faced serious food shortages due to a complex combination of factors including relatively insignificant climate shocks, HIV/ AIDS, debt, political problems in Zimbabwe and the collapse of commercial maize production (Vogel and Smith 2002). In October 2002, the governments of Malawi,1 Mozambique, Zambia and Zimbabwe made the decision to reject the importation of US food aid amid concerns over the inclusion of genetically modified maize. The United States offered aid in kind and could not guarantee that its maize did not contain GM maize, whereas most European donors offered cash to purchase maize on the open market. This decision quickly meant that southern Africa was incorporated into existing trans-Atlantic debates over trade in GMOs.2 Pro- and anti-GM lobbies sought to use the crisis to articulate their positions over agricultural biotechnology, genetically modified crops, trade and their role in development. In 2002, very few southern African countries had established their own national biosafety protocols or ratified the Cartegena Protocol meaning they had very little recourse to any legal apparatus when deciding how to deal with food aid. GM food aid was rejected by the four countries on two fronts, firstly and most tenuously the possible risk to human health in consuming the maize, and secondly and more importantly the possible impacts on future exportation of organic and nonGM maize if inadvertent cross-fertilization was to occur. GM maize referred to Bt maize, which was maize that had been genetically modified to express the bacterial Bacillus thuringiensis toxin, which is poisonous to insect pests. This was achieved by inserting a gene from the Bt pathogen microorganism into the maize genome. The Bt microorganism has also been inserted into other crops such as cotton with the aim of increasing insect pest resistance. Bt maize is widely grown across the United States, although debate still ensues regarding its efficacy and impacts, particularly in developing countries (Grouse et al. 2005; Marvier et al. 2007).

1 One of the reasons Malawi was so affected by the crisis was that the IMF and World Bank had urged it to sell its grain reserves to raise revenue for debt servicing. 2 The US and EU tension primarily revolves around regulatory differences between the two blocs. The EU developed its policy around the precautionary principle which states that if an action might cause irreversible harm to society or the environment, in the absence of scientific consensus the burden of proof falls on those advocating taking the action. The US position operates on the principle of ‘substantial proof’, as opposed to ‘scientific consensus’. See Murphy and Levidow 2006, for more detail.

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Malawi, Mozambique and Zimbabwe eventually accepted food aid on the proviso that all maize was milled prior to importation to avoid contamination.3 Zambia, however, continued to refuse to accept imports. Within Zambia there had been some consultation regarding the issue. Church groups, NGOs and farmers’ groups were consulted4 and independent scientific advice was sought. A team of government scientists was commissioned and spent time in laboratories in the US, the UK, Norway and the headquarters of the European Union. The issue became highly political within Zambia. Opposition groups were very vocal in their criticism of the President, Levy Mwanawasa, who in turn stuck to his position. The President’s position can partly be explained by the fact he did not enjoy broad support at home and aligning with a range of civil society actors and being seen to display his authority in the face of international pressure was good for his prestige (Smith 2003). The position of the scientific committee can partially be explained by the fact that Zambia does not have any significant technology-led private sector so scientists perhaps felt more able to be critical than might have been the case in South Africa or Kenya where private-sector or donor funding plays such a key role in bioscience research. More significantly, Zambia’s decision became the centre of ferocious international debate. Andrew Natsios, head of USAID contended that antiGM groups were ‘putting millions of lives at risk in a most despicable way’.5 Ann Veneman, the United States Secretary of Agriculture, described the actions of groups like Greenpeace, protesting that ‘instead of helping hungry people, these individuals and organizations are embarking on an irresponsible campaign to spread misinformation and create an atmosphere of fear’.6 The anti-GM lobby countered by arguing the US approach was simply a way to gain positive public relations for agricultural biotechnologies and introduce GM maize into southern African countries while they had little choice paving the way to introduce GM crops in the future. In any case, both Malawi and Zambia claimed they could source sufficient food within the region. The Zambian High Commissioner in London, stating ‘we can get more than 200,000 tonnes from South Africa … All we need is help with the logistics’.7 Outside of the region the issue caused tensions between the United States and the European Union to escalate. In January 2003, Paul Nielsen, the EU’s Overseas Aid Chief accused Robert Zoellnick, the US Trade Representative, of 3 It is interesting to note that the US refused to provide the funds for this milling. Zerbe (2004) argues this is evidence the US did indeed have an agenda to push the idea of GMO in these countries. 4 The make up of civil society organizations consulted was relatively urban and middle-class focused. 5 Cited in Vidal 2002. 6 Veneman 2002; USDA Statement 30 August 2002. 7 Cited in Vidal 2002.


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lying when Zoellnick stated that EU governments had threatened to withdraw aid from developing countries that used GMOs. He continued: This is a strange discussion. Very strange, we are approaching a point where I would be tempted to say I would be proposing a deal to the Americans which would create a more normal situation. The deal would be this: if the Americans would stop lying about us, we would stop telling the truth about them. This is a proposal for normalising the discussion.8

Europe’s position would ultimately provide justification for the United States filing a case to the World Trade Organization regarding Europe’s moratorium on importing GMOs. Zoellnick arguing that ‘This dangerous effect of the EU’s moratorium became painfully evident last fall when some famine-stricken African countries refused US food aid because of fabricated fears stoked by irresponsible rhetoric about food safety’ (Zoellnick 2003). The recent history of GM food aid in southern Africa demonstrates two things. Firstly, it demonstrates the limited ability of developing countries to make decisions regarding new technologies and new issues. This is primarily an issue of options. When resources are few and crises are easily reached there are simply very few choices countries such as Malawi or Mozambique can reasonably make. Confronted with new technologies, as in the case of the importation of GM maize, compounded by inadequate access to information it is not surprising that these countries were not able to reach considered opinions. Secondly, it demonstrates the way in which decisions are made elsewhere. Debates regarding the consumption of GM maize in the midst of potential famine were played out in offices and meeting rooms in the United States, Europe and Lusaka by ‘well-fed’ policymakers and lobbyists. A lack of government regulation may have created space for governance, but it did not create networks and mechanisms to include those most affected by the decision. One of the ideas that underpin a normative understanding of governance is ‘heterarchy’ (as discussed by Papaioannou in Chapter 2), the idea that within networks elements share similar positions of power and authority. This ideal state, something to which we are told policy-makers ought to aspire and the tools of representation help to achieve, seems far from the reality of drought-threatened Zambia in 2002. In some respects the case of Zambia represents another formulation of governance, that of the state as but one of many actors. When one unpicks who makes decisions and for what reason, however, the state appears as an entity that makes decisions from a position of weakness – reactionary, lacking information and making choices for posture as much as for science.

8 Cited in Reuters Press Release 20 January 2003.

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In such a context any ideal, idealized formulation of governance seems abstract and theoretical. From the perspective of developmental governance Zambia would most probably be labelled as ‘bad’ (by the United States at least) having rejected the fruits of development and progress. Governance is concurrently entirely abstract and extremely judgemental. Undoubtedly, the case of Zambia demonstrates policies, institutions and networks that could be implemented to prompt more evidence-based decision-making. The developmental governance agenda sensitizes us to making value judgements, however. What is palpable, though, is that Zambia’s history, its lack of choices, and the globalization of debate surrounding the trade of GM crops created an environment in which making decisions was difficult. That difficulty speaks to a whole set of developmental and policy-making issues that serve to constrain decision-making. That is the context in which resource-poor, underdeveloped states must attempt to live up to multiple external expectations of them. Prioritizing the Bioscience of Health Sleeping sickness, or the human form of trypanosomiasis, places approximately sixty million people in sub-Saharan Africa at risk and leads to 300,000 new cases per year (World Health Organization 2000). The extreme poverty of the afflicted population has created no financial incentive to develop new drug treatment and most of the drugs currently used to treat the disease were developed more than 50 years ago. Suramin and pentamidine, used to treat early stage disease, were developed in Germany shortly after World War I and in 1937 respectively. Late stage disease is predominantly treated by arseniccontaining compounds, some of which date back to 1932, such as melarsoprol (Coyne 2001). Only melarsoprol can cross the blood-brain barrier to treat late-stage sleeping sickness. The affordability, efficacy and environmental and clinical toxicity of these drugs is of increasing concern. A third of candidates do not respond to melarsoprol, one in 10 will die from the treatment itself. The drug is so corrosive it must be kept in glass vials as it eats through plastic ones. In the 1970s the synthesis of difluoromethylornithine, or eflornithine, as a potential anticancer drug that impaired cellular division was studied as a potential treatment for sleeping sickness. By 1985, the WHO was undertaking clinical trials in partnership with the drug’s manufacturer, Merrell Dow Pharmaceuticals (Bacchi et al. 1980). In some late-stage patients the clinical response was so strong that eflornithine was dubbed the ‘resurrection drug’ (Coyne 2001). In 1990, Merrell was granted approval for the drug making eflornithine the first new drug treatment for sleeping sickness in more than forty years. Treatment with the drug was expensive, however, with a 14-day course of treatment costing in the region of $700. This was prohibitive given the resources


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available in countries where trypanosomiasis was endemic. Subsequently, in the short-term Merrell agreed to supply the drug to WHO at cost while WHO sought a third party manufacturer to take on production. Uganda approved the drug in 1993 but by this time no third party supplier had been identified. In 1995 Merrell, now called Aventis as a result of a merger, finding both melarsoprol and eflornithine in its portfolio of drugs discontinued production of eflornithine as a cost-reduction measure: given the resource-intensive nature of the synthesis, it was simply not profitable. The remaining stocks of the drug were donated to Médecins Sans Frontières (MSF) in 2000. By the end of 2000 all remaining stocks were past their expiration date, and the entire stockpile was projected to last for no more than a further six months (Coyne 2001). During the late 1990s the best efforts of the WHO and MSF to find a third party manufacturer proved fruitless until it was noted that clinical trials in sleeping sickness patients identified hair loss as a side effect (Pepin et al. 1987). These observations led in 2000 to the development of a topical formulation of eflornithine, Vaniqa, by another drug company, Bristol-Myers Squibb, under licence from Aventis, to treat unwanted facial hair in women. This contrast in context and response, of African sleeping sickness and facial hirsutism in Western women, and the decision to produce eflornithine for cosmetic application and not as a treatment for a deadly disease led to somewhat embarrassed discussions between Aventis, Bristol-Myers Squibb, the WHO and MSF to reach some sort of solution.9 In May 2001, Aventis signed an agreement with the WHO and MSF committing $25 million over five years to produce with Bristol-Myers Squibb sufficient quantities of eflornithine for therapeutic needs, support MSF in supplying the drugs to the patient, and support research and surveillance of sleeping sickness control programmes. During the five-year period 200,000 bottles of eflornithine were produced by Aventis, donated to the WHO and distributed by MSF, saving an estimated 110,000 lives.10 In 2006 this agreement was renewed with a further five-year commitment by Aventis to supply eflornithine and other sleeping sickness drugs. It seems now there is a viable partnership in place to ensure the supply of therapeutic drugs for sleeping sickness, and plans to ensure the sustainability of drug manufacture and supply. Nevertheless, back in 2001 a Bristol-Myers Squibb spokesman inadvertently summed up the dichotomy of technology and inequality: ‘Before Vaniqa came on the scene, there was no reason to make eflornithine at all. Now there’s a reason.’11 The bifurcated development of eflornithine, for poor and latterly for rich, underlines the geography and the economics of the governance of biosciences 9 According to MSF the impetus behind this decision was the embarrassment the drug companies would feel if the situation were to become public. Something MSF had threatened to do. 10 Sanofi-Aventis, Press Release 12 March 2007. 11 Cited in Rosenberg 2006.

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in developing countries, for citizens of developing countries. Geographically, the imperatives of economics, and the relative absence of local markets, stretches decision-making regarding research and development, promotion of products and above all, prioritization of funding, research and products far from where demand cannot be articulated, markets cannot be stimulated and active ingredients may make big impacts. Eflornithine and the decisions made regarding when to produce it and for what purpose reflect profound global inequality, and that inequality is something set apart from the biosciences, even when the biosciences have the potential or wherewithal to address related problems. A lack of access to resources, to knowledge or to markets, or a lack of political power, all serve to limit the ability of individuals, communities and countries to fully exploit opportunities – including scientific knowledge and technological opportunities – and this is partially a cause of, and a manifestation of, disconnections in how governance works in developing countries. Underdevelopment and inequality is also manifested as an inability to represent one’s position or articulate one’s needs; eflornithine represents a good example of this. Ultimately, inequality is apparent in the relationship between opportunity and articulation, or between topical cream and course of treatment. This relationship cannot simply be reduced to a calculus of capacity, networks, innovations and benefit/risk, much as documents such as the UN Millennium Report might choose to articulate; rather it reflects a geography of deep-rooted social, political and economic problems in which bioscientific research is undertaken. Somewhat paradoxically, while science, as the driver of economic growth, is claimed as a sort of multi-sectoral silver bullet that can improve human welfare through innovation in public health, nutrition and agriculture (cf. Juma and Yee-Cheong 2005), technological innovation has almost always exacerbated inequality through time, and hence we need to think carefully about the role and concept of justice when thinking about governance of such potentially transformational technologies. This is made explicit when one considers the history of innovation and economic development and implicit in the calls for increased investment and emphasis on science and technology for development. Conclusion: Developmental Governance? These three case studies illustrate different slices of governance, or the absence of governance. The institutionalization of agricultural research as exemplified and represented by IRRI was a blueprint for the organization of research for development, for citizens of states but outside of states. This represented, and still does, the notion that ‘development’ to be effective must be globally organized via global institutions. This has had implications for both the direction of bioscientific research and for local and state capacity to undertake their own research. The Zambian state is an actor in the second


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case study, albeit a reactive actor, possibly ill-equipped to make effective choices. In the case of eflornithine it is telling that the state is entirely absent. In both cases, key decisions, for good or for bad, were made in the US and in Europe. Decision-making, or influence over decision-making, was based primarily on the foundations of globalization, freeing trade and maximizing profit. The various dynamics that shape the context of science policy-making in developing countries coalesce to sideline the state or remove it completely. This is a slightly provocative take on the governance of biosciences via two African case studies and chapters by Bryant, Harsh and Mugwagwa in this volume point to ways in which new modalities and approaches can draw communities, institutions and governments into decision-making processes. What this chapter seeks to do, however, is draw back and unveil a broader context in which remedial measures become central in forcing decision-making to become more representative and more evidence-based. This chapter also seeks to highlight deficiencies in our understanding of governance. From a developmental perspective, governance is ultimately always judged relative to the ideals of development, and may become a scapegoat for the failures of development. A more normative perspective of governance probably does not capture the context of complexity and constraint in which decisions are made in less developed countries. Where do we go from here? People have suggested using innovation systems as a metaphor for the organization of science and technology for development is useful in making the correct intellectual and organizational linkages to ensure innovation occurs (cf. Hall et al. 2001). This is undoubtedly true but fails to capture both the realpolitik of science and development and the inability of less developed countries, without significant external support, to create the infrastructure necessary to shape context-specific technologies. Governance seems a terribly abstract and distant term to describe the ideals of research excellence, the biography of eflornithine or the transnational politics of GM food aid. The private sector is becoming increasingly important, more so outside of national borders than inside, the capacity and infrastructure of the state has shrunk, ‘public’ research takes place in internationally funded research centres that may have few local ties, new technologies and the promises and risks of those technologies come thick and fast. All this takes place in the context of global development that struggles to make any meaningful impact against poverty. In this context many of the constructs and terms we rely on to describe and explain the governance of the biosciences in more developed countries are rendered if not meaningless certainly imprecise, or hopeful. The chapters by Bryant, Harsh and Mugwagwa in this volume will further explore the nature and limits of governance in these contexts.

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References Alston, J., Dehmer, S. and Pardey, P. (2006), ‘International initiatives in agricultural R&D: the changing fortunes of the CGIAR’, in Pardey, P., Aston, J. and Piggot, R. (eds), Agricultural R&D in the Developing World: Too Little, Too Late? (Washington DC: IFPRI, 313-60). Anderson, R. (1991), ‘The Origins of the International Rice Research Institute’, Minerva 29:1, 61–89. Bacchi, C., Natham H., Hutner, S., McCann, P. and Sjoerdsma, A. (1980), ‘Polyamine Metabolism: A Potential Therapeutic Target in Trypanosomiasis’, Science 21, 332–4. Biggs, S.D. (1990), ‘A Multiple Source of Innovation Model of Agricultural Research and Technology Promotion’, World Development 18:11, 1481–99. Chandler, R. (1992), An Adventure in Applied Science: A History of the International Rice Research Institute (Los Banõs: IRRI). Chataway, J. and Smith, J. (2006), ‘The International Aids Vaccine Initiative (IAVI): Is It Getting New Science and Technology to the World’s Neglected Majority?’, World Development 34:1, 16–30. Chataway, J., Smith, J. and Wield, D. (2007), ‘Shaping Scientific Excellence in Agricultural Research’, International Journal of Biotechnology 9:2, 172–87. Clark, N., Mugabe, J. and Smith, J. (2007), Governing Biotechnology in Africa (Nairobi: ACTS Press). Clark, N.G., Stokes, K. and Mugabe, J. (2002), ‘Biotechnology and Development: Threats and Promises for the 21st Century’, Futures 34:9, 785–806. Cleaver, H. (1972), ‘The Contradictions of the Green Revolution’, The American Economic Review 72, 177–88. Conway, G. (1987), The Doubly Green Revolution (London: Penguin). Coyne, P. (2001), ‘The Eflornithine Story’, Journal of the American Academy of Dermatology 45, 784–6. Glaeser, B. (1987), The Green Revolution Revisited: Critiques and Alternatives (London: Allen and Unwin). Gouse, M., Pray, C., Kirsten, J. and Schimmelpfennig, D. (2005), ‘A GM Subsistence Crop in Africa: The Case of Bt White Maize in South Africa’, International Journal of Biotechnology 7:1–3, 84–94. Hall, A., Brockett, G., Taylor, S., Sivamohan, M. and Clark, N. (2001), ‘Why Research Partnerships Really Matter: Innovation Theory, Institutional Arrangements and Implications for Developing New Technology for the Poor’, World Development 29:5, 783–97. Juma, C. and Yee-Cheong, L. (2005), Innovation: Applying Knowledge in Development, Taskforce 10 (London: Earthscan). Marvier, M., McCreedy, C., Regetz, J. and Kareiva, P. (2007), ‘A Meta-analysis of Effects of Bt Cotton and Maize on Nontarget Invertebrates’, Science 316:5830, 1475–7.


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Murphy, J. and Levidow, L. (2006), Governing the Transatlantic Conflict over Agricultural Biotechnology: Contending Coalitions, Trade Liberalisation and Standard Setting (London: Routledge). Paarlberg, R. (2008), Starved for Science: How Biotechnology is Being Kept Out of Africa (Cambridge, MA: Harvard University Press). Pardey P.G., Roseboom, J. and Beintema, N.M. (1997), ‘Investments in African Agricultural Research’, World Development 25:3, 409–23. Pepin, J., Milford, F., Guern, C. and Schechter, P. (1987), ‘Difluoromethylornithine for Arseno-resistant Trypanosoma Brucei Gambiense Sleeping Sickness’, Lancet 2, 1431–3. Polanyi, K. (1944), The Great Transformation: The Political and Economic Origins of Our Time (Boston, MA: Beacon Press). Rosenberg, T. (2006), ‘The Scandal of “Poor Peoples’ Diseases”’, New York Times 29 March. Smith, J. (2003), ‘Poverta, potere e resistenza: sicurezza alimentare e sovranita in Africa Australe’, Afriche e Orienti 2, 158–72. Smith, J. (2009), Development Matters: Science and Development (London: Zed Books). Stiglitz, J. (2003), Globalization and its Discontents (London: Penguin). Vidal, J. (2002), ‘US Dumping “Unsold GM Food on Africa”’, The Guardian Monday 7 October. Vogel, C. and Smith, J. (2002), ‘The Politics of Scarcity: Conceptualising the Current Food Security Crisis in Southern Africa’, South African Journal of Science 98:7/8, 315–17. World Bank (1981), The Berg Report: Accelerated Development in Sub-Saharan Africa (Washington DC: World Bank). World Health Organization (2000), World Health Report 2000: Health Systems: Improving Performance (Geneva: World Health Organization). Zerbe, N. (2004), ‘Feeding the Famine? American Food Aid and the GMO Debate in Southern Africa’, Food Policy 29, 593–608. Zoellnick, R. (2003), ‘United States v. European Union’, The Wall Street Journal 21, May.


Chapter 8

Ever-changing Policy Context: the One Stable Threat to Biotech Governance in Africa? 1

Julius Tazvishaya Mugwagwa

Introduction Policy and institutional processes for managing modern biotechnology in Africa, as elsewhere in the world clearly bring out how biotechnology regulation in many respects represents the ‘avant garde’ case of technology governance (cf. Nolke and Graz 2007). Biotechnology is characterized by highly dynamic technological developments and is inherently border-spanning in character, making it one of the most striking icons of globalization (Juma and Serageldin 2007). This has led to some policy practitioners declaring that the policy responses in Africa are therefore not surprising. The fact that they are in a perpetual state of change, with new organizational and individual players coming into the fray at every twist and turn of the dynamics within the technology are seen as necessary as the organizations and individuals jostle to position themselves strategically to deal adequately with the challenges posed by the technology. The result has been that many organizations, programmes and approaches have been put in place by both state and non-state actors on the continent to try to cope with the challenge of maximizing the benefits and minimizing the risks of modern biotechnology (Mugabe 2001). Inspired by the cross-national food security and technology challenge and policy responses ignited by the 2002–2003 food crisis in southern Africa (detailed in Smith Chapter 7), this chapter presents and discusses some of the processes and institutional responses that were spawned at cross-national levels, bringing to the fore some of the challenges and limitations faced by both state and non-state actors in bringing about and implementing technology governance mechanisms. 1 This work is derived from: Mugwagwa (2008), ‘Supranational Organizations and Cross-national Policy Convergence: The Case of Biosafety in Southern Africa’, PhD thesis (The Open University: United Kingdom). Acknowledgements to the Open University and the ESRC Innogen Centre for funding the research; and to Prof Joanna Chataway, Dr James Smith and Dr Peter Robbins for academic mentorship.

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This chapter argues that part of the reason why changes in policy processes and governance mechanisms for biotechnology are not clearly understood is because of the limited analysis of the deeper contextual realities behind the various institutional and policy responses. The underlying contextual terrain, made up of individuals and organizations, and the various coalitions among them, and facilitating factors overarching their activities have a huge bearing on the impact and identity of responses given to policy challenges. While ‘newness’ may be exhibited at the macro-level, in the form of new organizations and/or programmes, this chapter contends that it largely remains ‘business as usual’ at various other levels feeding into these organizations and programmes, posing a big threat to the envisaged impact of the new institutional and policy responses. Using the example of biosafety policy processes in southern Africa, this chapter brings to the fore some of the realities technology governance faces in a developing country setting, making a case for multipronged approaches, including bringing back government, even in an era where governments are agreed to be playing a receding role. The chapter argues that there are real challenges and concerns in the subregion and the member states which need to be taken on board more if a transnational governance framework is to emerge. Governance in this case is used more as it relates to the processes of creating conditions for ordered rule and collective action (cf. Stoker 1998), within a context where ‘no single actor has the knowledge and resource capacity to tackle problems unilaterally’ (Keohane 1988). Particular interest is on how the complex interactions at various levels within the southern African biosafety terrain shaped the cross-national governance agenda, and with what impact this had on the collective action desired. Among the main issues observed is that the emergence of new policy responses has both divisive and uniting properties alike among the new and existing players, setting the stage for abrasive interactions at various governance levels. In particular the chapter presents and discusses the challenges brought to the theory and practice of governance by this multidimensional interface between a new technology, limited regulatory preparedness among countries and the (apparently inevitable) plethora of new institutions and processes to manage it. The Biotechnology Debate The biotechnology and biosafety debate on the African continent is alive, both in relation to the bigger global debate shaped around the Cartagena Protocol on Biosafety, and as influenced by Africa’s geographical and socioeconomic peculiarities. Key among these issues are: the economic and social importance of agriculture in Africa; the degree of food insecurity and poverty on the continent; the pressures exerted on natural resources by the continent’s population with a view to satisfying food and nutritional needs; the vulnerable nature of Africa’s agriculture due to climate change, diseases and predators;

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the need to explore new ways of developing agriculture with a view to injecting a new lease of life into agricultural production in order to overcome food insecurity and alleviate poverty; the stake and importance of biotechnology in the development of Africa’s agriculture to set in motion a growth and economic development process in countries; and all this while needing to protect biodiversity, the environment and human and animal health (Mnyulwa and Mugwagwa 2005; NEPAD Framework Document 2001; SADC Review 2001). These challenges form part of the context within which Africa’s interest in the technology lies. From an external point of view, multinational companies and developers of the technology see Africa as a potential food market, and her largely underdeveloped agricultural systems as a testing ground for some of the nascent technologies; while the continent has obligations to meet Millennium Development Goals (MDGs) on food security, poverty and others, and the technology is seen as having a great potential to contribute to this. The interplay between these issues results in biotechnology, and indeed any technology meant to address some of these challenges, ceasing to be purely a technical issue, but one with added tensions as a result of the political and social dimensions (cf. Ruggie 1975). The political dimension not only brings challenges; it is also seen as a necessary force in galvanizing the different interests in the practice, and in pushing the issue towards the appropriate decision-making levels. Diminished Power of Governments – the Bigger Debates International relations scholars are in agreement that there is an increasing number of problems that national governments cannot solve unilaterally, for reasons that range from increased governmental responsibility in domestic affairs to the increase of collective problems attributable to globalization and scientific progress (Hasenclever et al. 2000; Sampson 1982; Finnemore 1996, 47). There has also been an ‘erosion of the long-familiar building blocks of the political world’ (Ohmae 1995, 7), and countries increasingly find themselves having to cooperate with others in dealing with collective dilemmas that transcend national boundaries. For developing countries, the area of regulation of modern biotechnology is one challenge largely viewed as warranting such collective action because of inherent country deficiencies, e.g. weak technical and decision-making capacities, among others (explained elsewhere in this chapter). However, cross-country cooperation is not an easy undertaking for political, economic and many reasons embedded in or transcending the countries. The conditions under which this cooperation is possible are thus the subject of intense research in public policy, international relations and allied areas (Stone 2000), all attempting to understand the transnational governance phenomenon.

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Coordination of policy at the international level is complicated by many factors, starting with the ambiguity and disagreement about definitions of ‘policy’; which means different things to different people, and invariably contains and expresses the conflicts and tensions of contemporary society (Considine 2005, 1). Policy-making happens in a world undergoing continuous change, with older institutions and governance systems breaking up, and new ones emerging. In most democracies, policies are essentially a result of multistakeholder processes, encompassing different sectoral and societal interests (Carlson 1999, 50). Yet, difficult as it may be to navigate, the policy environment is recognized as one of the key variables that have to be thought about and acted upon if countries are to benefit from any innovation or investment in research (Clark et al. 2005, 75). Countries of the Southern African Development Community (SADC)2 region have thus been making individual and joint efforts to develop and maintain a conducive policy environment with a balance between the risks and benefits of biotechnology. However, the biotechnology policy arena is highly contentious and has stagnated in many contexts as newer forms of modern biotechnology emerge (Puplampu and Essegbey 2004). The new technologies are entering an already-loaded context, where players have different prior beliefs and positions (cf. Mesegeur 2005). For example, the issues of biosafety and convergence of biosafety systems are enmeshed within the political economy of GM food, especially the often conflicting objectives between trade and environment management obligations (Stevens 1993; Murphy and Yanacopulos 2005) and this complicates the numerous dynamics at play (Russell and Vogler 2000, 2). Another of the many challenges around the technology and its governance is that it is dominated by a diminishing number of GM biotechnology giants (Somsen 2007, 98). Their aggressive corporate policies of control and the vulnerability of poor countries in the face of these powerful corporate actors and states is both a cause for worry, and a source of motivation for the cross-national cooperation aspirations, creating both the background and foreground for the emerging governance mechanisms. As a result, biotechnology is not only a dynamic scientific discipline, but it is also a game of high stakes hinging on poverty, polarization among interest groups and the seemingly elusive target for developing countries to develop adequate capacity levels to maximize the benefits and minimize the risks of the technology (cf. Walters 2004; Kinderlerer and Adcock 2005). The challenges at national level are understandably magnified when the issues play out at regional level. Regional collaboration is seen by some countries as an opportunity to ‘internationalize’ or ‘legitimize’ their domestic policy preferences and, among 2 The SADC is a regional economic community for 15 countries in southern Africa; namely, Angola, Botswana, Democratic Republic of Congo, Lesotho, Madagascar, Malawi, Mauritius, Mozambique, Namibia, Seychelles, South Africa, Swaziland, Tanzania, Zambia and Zimbabwe.


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many other facets, pointing to different motivations and therefore envisaged costs and benefits of the desired regional governance mechanisms. For the policy analyst and researcher, a look at regional governance systems comes hand in hand with a high diversity of the levels and identities of challenges to be considered, necessitating integration of diverse expertise and different knowledge sets in trying to understand the issue. Failure to do so may lead to wrong or misinformed explanations for observations made. Food Security and the Technology Governance Challenge This chapter focuses more on the regulation of biotechnology in the backdrop of its applications in agriculture and thus the examples cited both for interventions and challenges will draw mainly from this sector. This is because agriculture, which elsewhere is presently undergoing a technology revolution based on genetic engineering, genomics and other forms of biotechnology, is the mainstay of economic activity in nearly all of SADC’s member countries. Agriculture is a major source of foreign earnings and supplies food, thereby reducing hunger, ensuring social and political stability (UshewokunzeObatolu 2005). Biotechnology has also been touted as a technology with the cross-cutting potential to bring different sectoral, including national interests together (Bandelow 2006). Southern African countries have found themselves in the throes of food emergencies in the past, for example in 1991, when a severe drought combined with inadequate human, infrastructural and organizational capacity in domestic markets to severely constrain food supplies and left millions of people on the verge of starvation (Omamo and von Grebmer 2005, 2). The food emergency of 2002–2003 had, by and large, the same cast of issues – drought, infrastructural, organizational and policy factors – but with an additional challenge – that the thousands of tonnes of food available to help cover the shortages were suspected to contain unspecified amounts of genetically modified (GM) maize. Uncertainties around food and environmental safety and regulatory preparedness, among other challenges, meant that some countries were unwilling to accept the food aid, with some governments going on record to choose starvation, rather than have their people consuming ‘poisonous food’ (e.g. Panos Report No. 49 2005, 30). The challenges that this dilemma presented ranged from the grandiose and perennial challenges of putting in place regulatory and institutional arrangements to the mundane logistical hurdles of ‘how to load grain into rail cars and trucks with minimal escape, how to cover the loaded cars and trucks and how long to allow the trucks to sit in given positions’ (Omamo and von Grebmer 2005, 2). As exemplified by the quotations presented earlier, the scenario created tension at various levels, within countries, between countries, with food relief agencies and donors, among others, as countries of the region individually and

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collectively endeavoured to make the best decision under pressure from the food emergency and the uncertainty posed by the suspected GM-food (Moola and Munnik 2007). Apart from testing the governance mechanisms that had been put in place prior to the crisis, the dilemma is attributed with having raised the political temperature around the regulation of biotechnology, both within countries and at the cross-national level. At the national level for example, a number of decisions and measures had to be put in place to guide decision-making, with some countries, e.g. Malawi, Mozambique and Zimbabwe deciding to distribute only milled grain and Zambia refusing the grain outright (Mafa 2004; Moola and Munnik 2007; see also Smith Chapter 7). At the regional level, SADC agriculture ministers cited the lack of a harmonized regional position on GMOs as creating serious operational problems in the movement of food and non-food items, and recommended the formation of an advisory committee on biotechnology and biosafety to develop guidelines on this issue and the broader issues around biotechnology (SADC 2003). Meanwhile, SADC Heads of State in their August 2003 Summit in Maputo, Mozambique, set a deadline of December 2004 for all countries of the SADC region to put in place national biosafety systems (SADC 2004). Institutional and Policy Responses and Underlying Realities This context described above elicited various responses, or institutional imaginings among many organizations, including three supranationalorganizations (SNOs): the African Union (AU), the New Partnership for Africa’s Development (NEPAD) and the Southern African Development Community (SADC). The three, together with other regional and international bodies have initiated processes to assist the 15-country SADC region towards cross-national similarity or convergence of biosafety systems. They have positioned and portrayed themselves in ways they deem best to deal with the situation facing the countries and the region vis-à-vis the technology. This is all taking place within the context of the broader mandates that these organizations have for regional integration, among other areas of focus. Box 8.1 gives brief descriptions of each of the three organizations. The organizations claim to embody institutionalisms that are best suited to dealing with the policy challenge and the context. According to institutional theorists, institutions emerge from coercive, mimetic or normative pressures which push them towards ‘improved efficiency or a status of higher legitimacy’ (DiMaggio and Powell 1983). Looking at the organizations and policy processes, some of the emerging institutional ‘myths’ towards these efficiency and legitimacy ‘trappings’ include being responsive to needs, evidence-based, consultative, champions of an African agenda, learning organizations and humbling themselves as being ‘only but part of networks of many equals’. They do not see themselves as being more important than the other players.


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Box 8.1: The three organizations and their claims to cross-national cooperation The three organizations are all different, and influence policy processes in the target countries at different levels and through different mechanisms. The African Union (AU) has historical links to its predecessor, the Organization of African Unity (OAU), whose mandate was political solidarity among countries on the continent. The OAU championed a neoliberal political agenda, espousing respect for all countries, and recognition of the importance of the contribution of the various small ‘pieces’ towards the ‘whole’ of Africa. While lately more rigorous, and even then also championing economic integration of the continent, the pedigree of the AU is built around its political clout, dating back to the OAU. Even most of its structures reflect the representative political democracy reminiscent of most political systems. The New Partnership for Africa’s Development (NEPAD) on the other hand is an expert-driven, socio-economic development framework for Africa, being essentially a programme of the AU. Because of its desire for a politicsfree and more accountable development agenda, the NEPAD has sought to remove itself from the entrenched bureaucracy of the AU, and to present to the world and sympathizers a new development partnership that is not only neoliberal on paper, but in practice as well, and having unhindered efficiencies. NEPAD thus presents technical competence as its hallmark and trump card. The Southern African Development Community (SADC) is the regional economic community (REC) for 12 geographically contiguous countries of southern Africa and three Island States in the Indian Ocean. In addition to being the oldest among the three organizations, SADC brings closer to home the shared political and economic realities and dreams of these neighbouring countries. SADC on paper embodies both the political clout (through offering a framework much closer to the countries’ realities) and an opportunity for the countries to pool and utilize their technical expertise together. SADC thus serves as both a rallying point (being the community), and a platform for solving the development challenges of the region. It presents both technical and political authority.

However, these trappings are seen by others as ways of wanting to portray a sense of belonging and relevance, while for the organizations, this reflects the best way to deal with the apparently inexorable context in which the technological and policy issues are being dealt with. But therein lie some of the problems; for example, while all this is happening, there exists a general feeling among some respondents from civil society that not much has been done to endear the three bodies with the ordinary citizenry. It was felt there was a glaring gap around explaining NEPAD’s basic principles to citizens in the countries. Officials from the two other SNOs felt the NEPAD programme was designed to circumvent the purportedly unwieldy process of the African Union, and nothing more. These realities and tensions between the organizations painted a complex picture with respect to how they could work

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together without antagonizing each other in the policy space. Already, within the biosafety arena, it was clear that the organizations had contempt for each other’s capacity to deliver. The following reflection from one key player in one of the SNOs summed up this mood: Yes, I am on the technical committee for their Biosafety Project, but I do not bother myself to attend all the meetings because there is no progress there. There are too many anti-biotech activists in that group, and a lot of time is spent debating the pros and cons of biotechnology, an issue which we think is not core to the mission of the project. (Senior Policy Officer, 2 October 20063)

However, the other SNO sounded more optimistic and diplomatic about the relationship, as supported by the following statement made by one of its key players, when asked about the link between their biosafety project and the biotechnology/biosafety activities in the other SNO: There is representation on our committee from the other SNO, and this is supposed to form the link between our two initiatives. However the problem we experience is that their representative does not attend meetings, and some of the obligations on which they are supposed to deliver are not met. However, we feel this is an adjustment phase, and things will normalize as the project progresses. (Senior Policy Officer, 8 October 2006)

The problem with this is that there did not appear to be much time for the gelling expected to make things better for the project because at the time these reflections were made, the project was already halfway through its three-year mandate. While the policy actors seemed confident that an extension phase would be granted, there was no guarantee that in the extension phase things would work better. One factor supporting this was the entrenchment of this expression of contempt and tension within the institutions, which was only being manifested through the individuals. There may thus be no guarantee that things would change even in the event of individuals managing the programmes changing. It was clear from these exchanges that, ‘while officials cannot be decomposed to the organizations they represent’ (Chataway 1992, 35), there were institutional factors that shaped the officials’ perceptions and attitudes on policy processes and outcomes (Rothstein 2002). There was thus a need to look beyond the institutional setting to explore and understand the patterns brought about by the officials’ interests and issue framings. In addition, it was evident that as much as they had positioned themselves to avail solutions to the collective-action dilemmas facing the countries, the SNOs were also 3 These are anonymized respondents based on interviews conducted between 2006 and 2008.


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bringing potentially diversionary attributes to the policy arena. For example, like the countries they were trying to assist, the SNOs also faced problems with respect to adequacy of financial, technological and policy resources to make sustainable and autonomous policy decisions. Among other implications, the encounters described above underscore the existence of different motivations behind the institutional and policy responses, complicating the identity and stability of the emerging mechanisms, more so at the cross-national level. Tensions between actors were also revealed, and for governance mechanisms at the cross-national level, how to deal with these tensions in the absence of overarching regulatory authority. Further, there also exists powerful, yet invisible technological, regulatory and financial forces that have a huge bearing on the policy processes. The following sections highlight further realities brought about by the context within the countries and the region, and how these shape the development and implementation of governance mechanisms. Other Contextual Realities Cross-national cooperation aspirations are usually at a quandary with respect to dealing with the reality of countries being markedly different in many respects, including how to access and produce comparative empirical and policy data from the varied geographic and economic terrain of the region. Communication and accessibility capacities differ among the countries, and among the institutions within the countries leading to variations in people engaged in policy processes among the countries. As Nolke and Graz (2007) observe, transnational governance suffers from the fact that not all participating actors have equal power and ‘some are not represented at all’. They further note that this is particularly true for those of the ‘wider public interest and from developing countries that are lacking the detailed knowledge … to participate meaningfully in norm-setting and enforcement’. This was largely confirmed by the biosafety systems study in which it emerged that most of the people who were accessed to participate in the research were by and large the same people who participated in these issues on a continuous basis. They brought with them some ‘fatigue and cemented opinions’ in some cases, and a feeling that this was another ‘of the many studies on biosafety’ (e.g. Res4 (R) September 2006). However, it was also a fact that these actors had become opinion shapers and leaders on this issue because of their sustained participation, and it was opinions such as theirs which had a huge bearing on the policy processes in the countries and the region (cf. NEPAD and IFPRI 2004). A researcher within a technology studies organization in Africa remarked:

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The Limits to Governance We rely a lot on seasoned policy-makers because governments and stakeholders know them and trust them. New players are viewed with suspicion, maybe because most of them only enter the fray when a historic event has occurred … but [of course] we also value the importance of fresh ideas and opinions, so we slowly bring new players on board as well. That’s how we broaden the policy community. (Researcher, 12 October 2006)

Another set of critical challenges for this issue and the bigger governance aspirations revolved around timing and culture issues, particularly with regard to the extent to which stakeholders in different countries remembered and attached value to key episodes in the policy processes. This had a bearing on how they interpreted the various questions raised by the research, and the amount of time taken to respond to issues. Regarding timing of the research, there were mixed feelings among the respondents, some holding the opinion that biosafety activities in the region followed an episodic pattern, moving in sync with global and regional developments and challenges. While the discussions and activities under the Biosafety Protocol were on-going, and countries were implementing various biosafety activities with assistance from UNEP/GEF for example, the real impact, as one official in the SADC observed, was from the major events that jolted the governments into wanting to invest in policy development. Our governments work best under pressure, and there are many reasons for this. In this case, the best time to assess the seriousness and commitment of the governments to the regional agenda would have been around the time of the 2002–2003 food aid crisis. The issue of biosafety caught the attention of leaders then, and this in many ways gives a measure of what is achievable and what is not. Organizations generally align their capacities and machinery with the prevailing leadership opinions, and for all it is worth, the desired convergence probably came and served its purpose, and beyond that, countries have since moved on separately. (Researcher, 6 August 2006)

This was quite a thought-provoking opinion, and it emphasized the different values attached to triggers for governance responses (cf. Nolke and Graz 2007). While the point about how long the anticipated cross-national governance mechanism could hold was taken, why the research was felt relevant still, a point which was discussed with the above respondent, was that convergence/ harmonization was being talked about and championed post-2002–2003. This showed that there was a cause and underlying need for the convergence. In addition, measuring or assessing the policy responses beyond the excitement of the political rhetoric was important in revealing to what extent the agenda had been institutionalized and how prepared countries were to deal with a repeat of such challenges in future. One key theoretical and policy issue that emerged clearly from the discussion with this official, and from discussions


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with others, was that in some of the countries and organizations, responses are guided by a ‘surviving-for-the-moment’ mentality. Beyond current survival, things were expected to fall into place ‘somehow’. Different institutional and social cultures across the countries also brought some issues to the fore. For example, respondents from some countries such as Botswana had a fairly ‘laid-back’ approach to issues, and some respondents attributed this to the per-capita economic self-sufficiency of the country in comparison with the other countries in the region. A typical ‘no-hurry’ attitude was apparent among the respondents from this country, not only with respect to rate of responding to research queries, but even to when and how the crossnational regulatory systems should be achieved. A senior regulator and active representative of the country in regional and international biosafety fora had this to say on the sidelines of an international meeting: … why should there be a hurry to achieve convergence when individual countries are still developing their own systems? We all need to go through the same learning curve, without hurrying and worrying about who is at what stage. We can share and exchange experiences with other countries, no problem, but each country needs to go back and work according to its own capacity and requirements. (Meeting, 3 November 2006)

These sentiments underscored the challenges emanating from the different economic status of the countries, and the accompanying institutional and social cultures. Some countries and institutions could afford not to hurry, while for others, the biosafety challenges could only be surmounted from a collective action perspective. Still, even for the resource-endowed countries and institutions, the benefits of collective action were indicated to outweigh the advantages brought about by having resources because, as one respondent from a regional biotechnology and biosafety advisory committee aptly put it: The challenges from this technology are too numerous, and I do not see any single country being able to deal with all of them on its own. If European countries, with all their resource endowments and technological advancements saw it worthwhile to combine forces with their neighbours, what can be expected of our own poor and technologically vulnerable countries? (Senior Policy Officer, 9 March 2007)

The issue of countries seeing themselves as capable of ‘going it alone’ also manifested itself in the emphasis on strengths and national achievements observed when countries took part in experience-sharing fora. There appeared to be some competition among the countries, and a desire to show that ‘within our borders, we are making progress’, and there were specific groups of countries that were known to exhibit this competitive rivalry between

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each other.4 This scenario not only brought a challenge to the quality and authenticity of policy inputs given by respondents, but also ‘threw spanners’ in the cross-national systems, especially with respect to how this could emerge and be sustained. One way of trying to deal with this challenge was through looking beyond the formal space, and this was vindicated by the remarks from one EU-based respondent who has interacted extensively with science and technology policy (including biosafety) experts in the SADC region: The true picture of what is feasible and how it can be done cannot emerge entirely from the formal meetings and fora where government departments and other agents of research institutions are engaging in discussions. There are tendencies to want to outdo each other in these fora, and sometimes the reality on the ground is compromised. Venture into the informal space, or catch these same practitioners after their formal meetings and hear if they consistently ‘sing the same song’. (Researcher, 15 March 2007)

Different cultures in countries and institutions and these competition dimensions also resulted in some issues being ‘black boxed’ by some policy actors. For example, in some countries practitioners were able to openly name individuals or institutions whom they thought were negative forces in the biosafety arena and the cross-national governance agenda specifically, while in other countries this openness was not possible. This ‘black boxing’ and issueavoidance or skirting varied among countries, institutions and respondents, and was envisaged to have an effect on the policy inputs. Risk perception also differed among countries (cf. Hofstede’s model (Hofstede 1991) on dimensions of national culture), while the rating of issues on different scales provided in the questionnaire-mediated part of the research also showed that respondents had different opinions on what is ‘low, moderate or high’ for example.5 There was a general trend showing countries with less experience with the technology being more preoccupied with putting in place measures to predict and manage the uncertainty from the technology than countries with a longer association with the technology who focused more on reaping benefits from it. These differences in uncertainty avoidance have a strong bearing on the feasibility of cross-national convergence of systems, further supporting the path and legacy-dependency nature of policy processes (Considine 2005, 127). Respondents from some countries, for example Zambia, Mozambique 4 South Africa and Botswana are known for exhibiting this stance against each other; Lesotho and Swaziland also bemoaned what they termed a ‘big-brother attitude’ from South Africa. 5 Particularly on responses relating to feasibility of convergence; whether or not convergence should happen voluntarily or through imposition of models by policydonors; and to what extent each of the three SNOs had contributed to increase in similarity of systems across countries.


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and Malawi seemed to be consistently moderate in their ratings, while those from others, notably Botswana, South Africa and Zimbabwe tended to rate on the high side. This was the case for both national and regional level issues. These responses were postulated to reflect either confidence in the national systems or some desire to achieve more. On the other hand it also reflected the existence of national and institutional factors that shape regulatory officials’ perceptions of risk, and the process to regulate the risk (Rothstein 2002). The multi-level and multi-actor nature of biosafety was also a source of terminology interpretation tensions. The way regulators and policy makers understand biosafety was not the same as that for workers in NGOs, for example, or scientists practising the science in the laboratories. Among policy makers and regulators, biosafety was about policies and regulatory measures, and this was what came to their minds when the issue was raised. Practitioners from NGOs and civil rights lobby groups said to them biosafety immediately raised issues around food and environmental safety. On the other hand, scientists in the laboratories were not only worried about the safety of the products of their research, but their ‘human safety’ while they carried out their research procedures. Biosafety thus elicits different interpretations, and this has an impact on governance mechanisms, including the sufficiency of processes to come up with these mechanisms (Merk 2007). To the end desirable, governance measures have the challenge of balancing between following established policy traditions and being innovative (Nolke and Graz 2007). Apart from the challenge of the same words or terms eliciting different meanings, the biosafety arena also faces the challenge of different words which policy actors use in their daily discourses to mean one and the same thing. For example, there were many terms used to denote or imply the desire by countries to work collectively in dealing with the challenges posed by biotechnology. Terms such as collaboration, cooperation, integration, rationalization, coordination, levelling-the-field and harmonization, among many others, were used frequently and often interchangeably to express desires for a shared cross-national governance framework. As highlighted earlier, the challenge for governance is to try and reflect these various framings in the processes and the emerging mechanisms, underpinned by appreciation and understanding of the practical meanings and implications of each of these terminologies. It was also quite sobering to realize that some of the terms were used by stakeholders to maintain currency with prevailing ‘buzzwords’ especially among the donor communities. One respondent from a regional biodiversity programme cautioned: You have to be very careful and to be sure that people mean and do what they say. You can be sent on a wild goose chase! There are people and organizations who use certain terms just to please donors while on the ground they have a different work ethic altogether. How many organizations have you heard claiming to be stakeholder-driven, bottom-up and so forth? Even

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The Limits to Governance these desires about harmonization or convergence … one needs to see how they are reflected in national documents in order to judge the commitment of countries to the ideal.6 (Ngo1 (R) July 2007)

An analysis of major national and regional documents on biosafety revealed that indeed the desire for cooperation or collaboration was expressed.7 However, different terminology was used to refer to the same aspirations, and whether or not this was again the result of an influence from the ‘donor’ community, was unclear in many cases. The presence of these terms was taken to mean that countries and the region were indeed pursuing the cross-national cooperation agenda (or however this desire may be denoted!), and the challenge still remained how this was being facilitated by the three supranational organizations. Convergence on terminology was probably one of the many pieces that needed to come together in the quest for convergence in regulatory practices. A leading figure in one of the supranational organizations even suggested a study to trace the evolution of some of the current terminology, and how they had impacted on delivery of processes on the ground. The term ‘biosafety’ itself was suggested as one whose development needed to be unbundled. What was clear from these encounters and descriptions was that issue framing had an impact on the delivery of programmes on the ground, with some framings serving as more effective rallying points than others. Confirming Contentions Narrated above are confirmations of how the governance of biotechnology at the cross-national level in southern Africa is a site of contention between different social, economic, technological, political and several other forces. This further confirms the complexity of the cross-national technology governance agenda; with some of the issues behind this complexity being diverse and fluctuating understandings, fears and motivations for the governance agenda; underpinned by subnational, national, regional and extra-regional forces. These forces shape the reality of what the various organizational players and the countries have to deal with in the envisaged multi-country governance

6 The challenge of some approaches being reduced to mere rhetoric, and in some cases being even used for manipulative purposes has been written about by many authors. For example, Samuel Hickey and Giles Mohan in their book Participation: From Tyranny to Transformation? – Exploring New Approaches to Participation in Development analyse these issues, and also propose how participation can be used to result in genuinely transformative processes and outcomes. 7 For example, in missions and mandates for AU, SADC, NEPAD and other regional bodies.


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structure, laying bare the realities and fallacies that face the cooperation aspirations which have been on the regulatory agenda table for a long time. This chapter not only confirms complexity, but informs that the complexity is underpinned by many forces that do not necessarily come to the fore if not unearthed by careful and multi-method study which looks beyond the everyday arenas where the policy processes are played out. For example, in the backdrop of a mixture of technology-inherent and technology-transcending challenges facing the policy agenda as revealed by the empirical evidence, it became clear that a purely techno-centric approach to the governance of the technology is less likely to be successful. This calls for the three SNOs and other organizations to synergize their different capacities and strengths if successful boundary crossings at the various levels are to be achieved. With different motivations and levels of caution, countries of the SADC region appeared to be in agreement on the need for a transnational governance framework for biosafety. If the signals on this were not clear enough, what was undoubtedly clearer was that stakeholders were keener on owning the processes towards that transnational framework, before the framework itself was put in place. This resonates with what Stevens (1993) notes in an article on harmonization, trade and the environment … that ‘for the most part, the purpose of these efforts is not so much to achieve identical regulations or standards, but to converge international methods for developing and administering standards’. The different challenges surrounding participation in the standard-setting processes form part of the realities that need to be countenanced if effective frameworks are to emerge. One of these realities is that biotechnology or biosafety policy is a policy measure in many policy fields, such as industry, science and technology, education, environment, agriculture, trade and others, and this elevates the challenge of cross-national comparison to higher levels. In addition, there are many other policy measures which are closely related to and overlap with biosafety, for example food safety, sanitary and phytosanitary measures, environmental safety, among others, and there are different levels of focus on these issues in the different countries. Attaining similarity of biosafety governance mechanisms at the cross-jurisdictional level has to take all this into consideration, and depending on the location of policy actors from whom opinions are sought, different levels of enthusiasm for the crossnational governance framework are likely to be encountered. There are also continuous changes at the bureaucratic and institutional levels in most countries which result in government departments emerging or disappearing frequently, and this presents both conceptual and operational challenges to the policy processes as well the emerging governance mechanisms and their effective implementation. Issues of hype around the technology (inevitable as they are because of the quest by scientists to receive attention) add to the pressure on the technology and the regulatory processes. However, due to the newness of the technology

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in the region, extended timescales for responses are also inevitable in the regulatory process, and pitting these together adds to the complexity around the cross-national governance aspirations. The unrelenting national and regional socio-economic and political context affects both feasibility and sustainability of regional governance aspirations. For example, as much as countries see the benefits of crosscountry cooperation, from their own realities and from experiences elsewhere, e.g. in the OECD and the EU countries, the historical and bilateral realities of the countries in the region often limit the autonomy that they have in the international policy space, and without taking this into consideration, governance mechanisms are bound to ‘misfire’. Most of the countries are too committed in other arrangements that pre-date the cross-national agenda, and which were in place to prop the countries’ waning economic fortunes. Extraregional powers, in the form of individual countries or groups of countries, companies, private foundations and others have a divisive effect on the region through their resource partnerships with some countries. Meanwhile, in some countries the limited visualization of immediate economic benefits from the cross-national cooperation continuously dampen its prospects as a long term socio-economic development target. One consistent challenge for regional governance mechanisms in southern Africa is the strong perception among many stakeholders that regional policy aspirations and processes are easily reversible. This dampens the commitment and motivation of policy actors towards the regional ideals as they have to embark on new initiatives every now and then, with a majority of the initiatives being abandoned mid-stream or completed but with no follow-up activities afterwards. On the other hand, these changes were seen to reflect the continuous effort by the governments in the region to position themselves adequately to deal with the policy challenges in the backdrop of a national and regional policy space that was congested and contentious. Meanwhile, some practitioners pointed out that cross-national governance systems would not necessarily address the implementation challenges faced by countries and the region. Examples were cited of how difficult it is for scientific research partners to access facilities set up in other countries. Thus, in the event of countries having to share resources as part of implementing the regional system, such issues would have to be taken into consideration. The countries are at very different levels of technological and regulatory development, affecting the impetus with which they address science and technology issues. This leads to insecurity among some countries emanating from fears of losing revenue and job opportunities as well as fears by more fragile economies, of being dominated and marginalized by stronger ones. This underscores the broader and technology-transcending challenges facing the biotechnology governance agenda in southern Africa. It is clear that a regional system would emerge and would be effective only if local specificities are taken into account in the development process. However, the local specificities around biosafety


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remain fluid and elusive because they are under bigger external and internal forces, and this further complicates the cross-national governance agenda. It also appears that while the technology has a modernizing effect on the countries and the regulations, it does not seem to carry enough ‘weight’ to overcome the broader contextual barriers in the region. There is a feeling among policy actor respondents that until the countries are in a position to make their own decisions on the technology, then the threat of the external forces will remain strong and decisive regarding where individual countries or the region can go. Conclusion This chapter has looked closely at the organizational and technological context overarching the cross-national cooperation aspirations in biotechnology. The dominance of this context is clearly visible, raising the stakes for the processes and envisaged outputs of governance mechanisms. One of the key issues emerging from this analysis of the context is the importance of the processes towards attaining the desired regional frameworks, as opposed to the mere attainment of the governance frameworks. Different resources and players will be needed for a successful emergence and implementation of the envisaged cross-national governance framework, including the state command-andcontrol (‘government’) approach to regulation, taking cognizance of the deepseated technological and policy sovereignty desires of the different countries. On the other hand, the involvement of stakeholders such as NGOs does not only bring the much needed breadth and transparency to the policy dialogues (‘governance’), but also results in more flexible and efficient policies within a democratized regional policy space. Whether or not the desired leadership, legitimacy and commitment to such broad-based processes exist, and how to attain a balance between this and the ‘government’ approach is critical and remains subject to much empirical scrutiny. References Bandelow, N.C. (2006), ‘Biotechnology Policy Convergence in Continental Europe? Political Institutions, Problem Framing and Learning’, German Policy Studies 3:4, 587–94. Birner, R. and Linacre, N. (2008), ‘Regional Biotechnology Regulations: Design Options and Implications for Good Governance’, International Food Policy Research Institute Discussion Paper 00753. Carlson, C. (1999), ‘Convening’, in Susskind, L.E., McKearnan, S. and ThomasLarmer, J. (eds) The Consensus Building Handbook: A Comprehensive Guide to Reaching Agreement (Thousand Oaks, CA: Sage Publications).

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Chataway, J.C. (1992), ‘The Making of Biotechnology: A Case Study of Radical Innovation’, PhD thesis (Open University). Clark, N., Mugabe, J. and Smith J. (2005), Governing Agricultural Biotechnology in Africa: Building Public Confidence and Capacity for Policy-Making (Nairobi: African Centre for Technology Studies Press). Considine, M. (2005), Making Public Policy (Cambridge and Malden, MA: Polity Press). DiMaggio, P.J. and Powell, W.W. (1983), ‘The Iron Cage Revisited: Institutional Isomorphism and Collective Rationality in Organisational Fields’, American Sociological Review 48:2, 147–60. Finnemore, M. (1996), National Interests in International Society (Ithaca, NY: Cornell University Press). Hasenclever, A., Mayer, P. and Rittberger, V. (2000), ‘Integrating Theories of International Regimes’, Review of International Studies 26, 3–33. Hofstede, G. (1991), Cultures and Organizations: Software of the Mind (New York: McGraw-Hill). Juma, C. and Serageldin, I. (2007), ‘Freedom to Innovate: Biotechnology in Africa’s Development’, a report of the High-Level African Panel on Modern Biotechnology (Addis Ababa and Pretoria: African Union (AU) and New Partnership for Africa’s Development (NEPAD)). Keohane, R.O. (1988), ‘International Institutions: Two Approaches’, International Studies Quarterly 32: 4, 379–96. Kinderlerer, J. and Adcock, M. (2005), ‘Agricultural Biotechnology, Politics, Ethics and Policy’, in Omamo, S.W. and Grebmer, K.von (eds) Biotechnology, Agriculture and Food Security in Southern Africa (Washington DC and Harare: IFPRI and FANRPAN). Mafa, A. (2004), ‘Managing Biotechnology in Zimbabwe’, paper presented at a national stakeholders’ workshop to present the Draft National Biotechnology Policy and National Biotechnology Management Authority Bill (Sheraton Hotel, Harare, 9–10 December). Merk, J. (2007), ‘The Private Regulation of Labour Standards: The Case of the Apparel and Footwear Industries’, in Graz, J.-C. and Nolke, A. (eds) Transnational Private Governance and its Limits (London and New York: Routledge/ECPR Studies in European Political Science), 115–26. Meseguer, C. (2005), ‘Rational Learning and Bounded Learning in the Diffusion of Policy Innovations’, Working Paper No. 316, Centre for Advanced Studies in the Social Sciences (Madrid: Juan March Institute). Mnyulwa, D. and Mugwagwa J.T. (2005), ‘Agricultural Biotechnology in Southern Africa: A Regional Synthesis’, in Omamo, S.W. and Grebmer, K. von (eds) Biotechnology, Agriculture and Food Security in Southern Africa (Washington DC and Harare: IFPRI and FANRPAN). Moola, S. and Munnik, V. (2007), ‘GMOs in Africa: Food and Agriculture’, Status Report 2007 (African Centre for Biosafety).


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Mugabe, J. (2001), ‘Biotechnology and Sustainable Development in Africa: Towards Regional Consensus and Common Strategy’, paper prepared for the African Ministerial Conference on Science and Technology. Murphy, J. and Yanacopulos, H. (2005), ‘Understanding Governance and Networks: EU-US Interactions and the Regulation of Genetically Modified Organisms’, Geoforum 36, 593–606. NEPAD and IFPRI (2004), ‘African Policy Dialogues on Biotechnology’, Report of First Steering Committee Meeting, Johannesburg, May. New Partnership for Africa’s Development (2001), ‘Framework Document’, (accessed 14 April 2006). Nolke, A. and Graz, J.-C. (2007), ‘Limits to the Legitimacy of Transnational Private Governance’, paper prepared for the CSGR/GARNET Conference Pathways to Legitimacy (University of Warwick, 17–19 September). Ohmae, K. (1995), The End of the Nation State: The Rise of Regional Economies (New York, London, Toronto, Sydney, Singapore: Simon and Schuster Inc.). Omamo, S.W. and Grebmer, K. von (eds) (2005), Biotechnology, Agriculture and Food Security in Southern Africa (Washington DC and Harare: IFPRI and FANRPAN). Paarlberg, R. (2000), ‘Governing the GM Crop Revolution: Policy Choices for Developing Countries’, Food, Agriculture and the Environment Discussion Paper 33, 1–44. Panos Report (2005), ‘The GM Debate – Who Decides? An Analysis of Decision-making about Genetically Modified Crops in Developing Countries’, Report No. 49 (London: Panos). Puplampu, K.P. and Essegbey, G.O. (2004), ‘Agricultural Biotechnology and Research in Ghana: Institutional Capacities and Policy Options’, Perspectives on Global Development and Technology 3:3, 271–90. Rothstein H (2002), ‘Neglected Risk Regulation: The Institutional Attenuation Phenomenon’, paper published by the Centre for Analysis of Risk and Regulation (London School of Economics and Political Science). Ruggie, J.G. (1975), ‘International Responses to Technology: Concepts and Trends’, International Organisation 29:3, 557–83. Russell, A. and Vogler, J. (eds) (2000), The International Politics of Biotechnology: Investigating Global Futures (Manchester: Manchester University Press). SADC (2004), Regional Consultation on GMOs, Concept note for a workshop held in Johannesburg, South Africa (29–31 January). SADC (2003), SADC Guidelines on GMOs, Biotechnology and Biosafety, Southern African Development Community Advisory Committee on Biotechnology and Biosafety, (accessed 10 March 2006).

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SADC Review (2001), ‘Poverty Reduction: A Top Priority in SADC’, (accessed 10 March 2006). Sampson, M.W. III (1982), ‘Some Necessary Conditions for International Policy Coordination’, Journal of Conflict Resolution 26:2, 359–84. Somsen, H. (ed.) (2007), The Regulatory Challenge of Biotechnology: Human Genetics, Food and Patents (Cheltenham: Edward Elgar). Stevens, C. (1993), ‘Harmonisation, Trade and the Environment’, International Environmental Affairs 5:1: 42–9. Stoker, G. (1998), ‘Governance as Theory: Five Propositions’, International Social Science Journal 50, 17–28. Stone, D. (2000), ‘Learning Lessons, Policy Transfer and the International Diffusion of Policy Ideas’, Centre for the Study of Globalisation and Regionalisation, Working Paper No. 69/01 (The University of Warwick). Ushewokunze-Obatolu, U. (2005), ‘Biosafety Policy’ in Omamo, S.W. and Grebmer, K. von (eds), Biotechnology, Agriculture and Food Security in Southern Africa (Washington DC and Harare: IFPRI and FANRPAN). Walters, R. (2004), ‘Criminology and Genetically Modified Food’, British Journal of Criminology 44:2, 151–67.

PART 3 People


Chapter 9

Advocacy Groups as Research Organizations: Novel Approaches in Research Governance Nadja Kanellopoulou

Introduction This chapter presents a case of innovative governance by focusing on genetic advocacy involvement in the management of biomedical research. Patient advocacy activities since the early 1990s have led to the development of novel governance modes and methods, in genetic and genomic research in particular. These are explored here as part of a volume dedicated to the emergence of new models of governance in the life sciences. Examples of how research has been accelerated by advocacy and patient group involvement are discussed to assess the ways in which patient advocacy groups facilitate and contribute to research. Their strategies include collective management of joint resources; promotion and funding of research; claims in controlling research direction and outcomes, contracts and ongoing interaction with researchers, funding institutions and policy-makers. In as much as these groups emerge as stakeholders in re-negotiating research relationships, complex questions arise about their role and overall influence in research. These include concerns about their methodologies and long-term planning, the adequacy of existing mechanisms to incorporate their diverse interests and values, and the role of law in regulating advocacy activities in a responsive, responsible and efficient manner. This chapter examines closely this last aspect of advocacy activities and their regulation. The realization that genomic research is collective and that it does not affect just individuals has fuelled attempts to develop legal protections for groups in biomedical research (Knoppers 2000, 212; Merz 2002, 965; Weijer 2000, 367). Emerging interest in patient group activities is nurtured by strategies to encourage participation in the interest of science, paired with efforts to cultivate a climate of willingness and trust towards research (Chadwick and Berg 2001, 318), and novel approaches to promote particular interests in influencing the direction of research on specific diseases, for example, with the development of group contributions and joint resources.

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These developments give rise to questions of how group contributions can be measured and how group control over those resources can be secured (Anderlik and Rothstein 2003, 450; Merz 2002, 965). Patient advocacy initiatives help us reflect on the nature of regulatory instruments, novel policy approaches and legal protections that could be in place for groups as research participants. This chapter discusses i) how research is facilitated by advocacy groups with the creation of resources and the negotiation of conditions to strengthen group influence in the management of research, and ii) how their role can be understood, and their interests protected, from a legal viewpoint. From an organizational perspective, advocacy activities offer valuable insights in the study of self-governance mechanisms. Advocates operate by establishing rules and procedures that provide a mutual understanding and commitment with researchers. These processes can lead to soft law regulation options, not legally binding but descriptive of the activities and situation of those who set them and effective for those who follow them (Ahrne and Brunsson 2004, 171). Patient Advocates and their Interests An Overview Patient advocacy groups nowadays organize themselves in supportive clusters of disease families to steer research towards the identification of particular genes for specific diseases, for example, Cystic Fibrosis Foundation, Tay Sachs and Allied Diseases Foundation, PXE International, Consumer Advocacy Genomic Health Inc. (Terry 2007, 157). The first patient support organizations for genetic diseases appeared in the late 1960s with the aim of providing emotional and social help to affected patients and families. These initiatives were encouraged by a pre-existing culture of patient support groups that had been forming in the US since the 1930s, inspired by an ethos of ‘selfreliance, familiarity, informality, and pioneer mentality’ (Terry 2007, 158). Over time, they developed into organizations aimed at providing more than psychosocial sustenance, between the 1970s and early 1990s, by starting to work together with scientists towards the identification of genetic markers – an example being the Hereditary Disease Foundation for families affected by Huntington’s disease (Terry 2007, 158). It was not until the mid-1990s that family advocates started to seek to initiate and fund research – as for example, the AT (ataxia telangiectasia), Children’s Project Chromosome 18 Registry and Research Society (Terry 2007, 158). And it was such initiatives that prompted Boyd et al. (1997, 8 and 195–6) to refer to notions of ‘professionalism’ in the definition of advocacy and related pressure group activism. By the late 1990s, new forms developed, with a focus on catching researchers’ attention, because many of the rare diseases that affected patient group families were not attracting the interest of either national funding agencies

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or the private biotechnology and pharmaceutical industry (Rajan 2006, 194). This new model of advocacy group combines the pursuit of progress in basic genetic science, epidemiological and clinical studies via ongoing cooperation of families affected by a particular disease and researchers, together with the facilitation of the development of technologies and access to treatment for those families. Their approaches to translational research include the pathway from research on the genetic basis of a rare disease to the pursuit of prognostic, diagnostic and therapeutic strategies of direct benefit to patients. The primary agenda of current alliances is the acceleration of research and its translation to new therapies for patient families. Key advantages of these groups are their ability to engage large numbers of patient families in research by tracing affected families, organizing the collection of health data and samples in disease registries and tissue banks, developing close collaborative relationships with academic science and industry researchers and taking risks in translational research. Patient advocates promote research on rare diseases and foster alliances for research management and opportunities. They develop resources and advance research that would not have been possible otherwise – not within the realms of university research because of the costs involved, and neither in the realm of venture capitalists, as the market is not big enough to make up for the investment risk taken (Merz et al. 2002, 118). Advocacy groups operate as gatekeepers and can make decisions about which researchers may get access to affected families, by networking with other volunteer groups, fundraising or funding research, organizing research workshops or lobbying for better legislation. They have developed considerable strategies in the last few decades; these reveal the complexity of interests involved over who has control of resources, how much control of resources a group can have, and who can directly benefit from research and its products. The appeal of such collaborations to both researchers and policy-makers is manifold; by identifying and providing access to affected families, securing data and samples, sharing the costs of research, and developing research resources and clinical outcomes, advocacy groups greatly facilitate both research and its translation to healthcare (Terry 2007, 1591). They increase credibility and trust towards researchers who commit to collaborate with them. They encourage public confidence in the capacity of genetics and genomics to improve human health.2 Numerous examples of advocacy groups now provide valuable resources for the realization of studies that may not have 1 The author provides a chronological table with examples of advocacy organization achievements; major achievements include research consortia, sample collection, donor registries, clinical databases, biorepositories and tissue banks, gene discoveries, gene tests and testing programmes, clinical trial networks and clinical trial recruitment, among others. 2 For a comparative example from the UK, see Genetic Interest Group (GIG).

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otherwise been possible. Their role is increasingly valuable as they become essential in encouraging research on rare diseases, fostering alliances and accelerating provision of therapies (Rajan 2006, 194), with key examples in the cases of the Canavan Foundation, PXE International, NAPE, Alpha-1, DebRA International. More recently, advocacy activities have led to the formation of coalitions of several patient organizations worldwide. These contribute to centralized biorepositories and help maximize training, research and funding opportunities, in the search for positive health outcomes for people affected by rare diseases; a major example is the Genetic Alliance Biobank, founded in 2003, a coalition of over 600 disease advocacy organizations, with three mandates: advocacy, education, and empowerment (Genetic Alliance website). Commentators, including advocates themselves, have increasingly stressed the role of advocacy groups as innovators (Rajan 2006, 196; Terry 2007, 157; Terry 2003, 377; Rose and Novas 2004, 3). Currently, patient advocacy groups in genetic diseases use a variety of strategies to promote research and accelerate the possibility of therapies for their members. These can be summarized under the following five strands of activities: • coordination of families (‘community engagement’); • ongoing engagement with scientists; • creation of resources throughout the research process and its applications; • negotiation of conditions with partners at the outset of collaborations; • pursuit of joint intellectual property rights with laboratories and industry. Yet, as good as their contribution and assistance can be, problems arise in advocates’ collaborations with the research establishment, especially in respect of possible commercialization of developed research. As the drive to map the genetic basis of disease has undeniable commercial aspects, problems occur in these collaborations, particularly when research institutions or researchers seek patents on genetic sequences or on the diagnostic tests they develop from joint work. Let us consider two prominent examples which attracted jurisprudential and academic attention in the early 2000s. The Canavan Foundation (Greenberg) A patient advocacy group in this area gained jurisprudential attention during the preliminary hearing of the Greenberg case, in the early 2000s. The case Greenberg v. Miami Children’s Hospital – also known as the Canavan case – involved an arrangement between parents of patients and a biomedical researcher over the commercial tests developed to identify persons carrying


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the mutation of Canavan disease, with their assistance (Greenberg v. Miami Children’s Hospital 2003). In this controversy, patient families contributed commitment, planning and organization skills but they failed to understand the milieu: as a (partial) consequence, the property claims – including intellectual property – that the Greenbergs forwarded were rejected by the court. The Greenbergs, parents of children who suffered and died from Canavan disease, a rare brain degenerative disease affecting one in 6,400 Ashkenazy Jewish children, sued researchers involved in the research and subsequent patenting of the gene for Canavan disease. The Greenbergs, together with the Canavan Foundation, the National Tay-Sachs and Allied Diseases Association (NTSAD) and Dor Yeshorim representatives, filed a lawsuit against Miami Children’s Hospital Research Institute Inc. (MCH) and Dr Reuben Matalon, asserting, inter alia that the hospital and the researcher were exercising the patent rights that they had obtained over the Canavan gene and the licence rights they had pursued over the associated diagnostic test, to whose breakthrough discovery the families had contributed substantially, in ways that were unacceptable to the patient families. Following the issue of the patents, MCH had asked laboratories which were already offering the test for royalties to continue to offer the test – the Canavan Foundation had offered genetic testing free of charge but had to stop after they were advised that they would be required to pay royalties to the patent holder (MCH) and to comply with set licence terms to continue offering the Canavan test (Bernier et al. 2004, 33). MCH sought to enforce the patent and some labs already providing the test had to end the practice. Patients’ families felt that the researcher and the University (MCH), as his affiliated Institution, intended to profit commercially from the test, without taking their contribution into account even though they had assisted substantially in the discovery of the gene. They felt strongly that they should not have to pay for testing, especially since the research was developed with their assistance (Gorner 2000). The plaintiffs protested that MCH and the researcher had not informed them about the patent and that their contribution to the discovery was neither acknowledged nor compensated. The Canavan plaintiffs were disenchanted in that the defendants had used group members’ tissue samples and genetic information without acknowledgment and for their own exclusive economic benefit (Merz 2002, 102–6; Gorner 2000). They sought to block Miami Children’s Hospital’s commercial use of the Canavan gene and recover damages of more than $75,000 derived from royalties collected for the gene test. They claimed a property interest in their body tissue and genetic information, and that they owned the Canavan registry which contained contact information, pedigree information and family information of Canavan families worldwide. However, at a preliminary hearing, the Florida District Court held that these were research donations without any expectations of return and declined to recognize a property interest in the bodily tissue and genetic information

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voluntarily given to the hospital. The court reasoned that the property right in blood and tissue samples evaporates once the sample is voluntarily given to a third party (the court cited the Moore Supreme Court stipulation that a donor has no property interest in the removed tissue after they have made the donation3). The Canavan plaintiffs used an additional argument based on a corn seed company case, the Pioneer case, where the Southern District Court of Iowa had previously held that a company’s property interest in the genetic message contained in a corn seed variety is property protected by the laws of conversion (Pioneer Hi-Bred v. Holden Foundation 1994). The Greenberg court noted the reasoning of the Pioneer court in that ‘where information is gathered and arranged at some cost and sold as a commodity on the market, it is properly protected as property’, but they saw this recognition as ‘more support for property rights inherent in the hospital’s research rather than the donations of plaintiffs’ DNA’ (Greenberg 2003, 1075; Bovenberg 2004, 8)! The irony in the comparison between this case and the precedent that had been set earlier (Moore) is palpable: in the Moore the court rejected the patient’s property claim to his excised cells considering that, if granted, such claims would hinder research by restricting access to the necessary raw materials and would create a litigation lottery for researchers (Mason and Laurie 2006, 521); in Greenberg, the group wanted the research information and outcomes to be freely available, against the wishes of the University to privatize and commercialize them, and hence restrict access to them that would potentially hinder research! Some commentators note the quirk, see notably Mason and Laurie (2006, 523) and more recently Rao (2007, 378–80) who sharply sums it up as follows:

3 In 1976, John Moore underwent treatment for a rare form of leukaemia at the Medical Centre of the University of California, Los Angeles. Dr Golde, his physician, recommended surgical removal of his abnormally large spleen, without disclosing to Moore his intent to obtain portions of the spleen for research purposes. In a series of post-operative visits, Golde withdrew substantial amounts of blood and other samples. He cultured a cell line from Moore’s T-lymphocytes and discovered that the cells had a unique ability to produce a protein that might be used to develop an anti-cancer agent. While the Regents of the University of California filed a patent application for the cell line, Golde, in spite of repeated representations to Moore that there was no commercial value to his bodily substances, negotiated agreements for commercial development of the line, worth, according to many commentators, millions of dollars. When Moore found out what had happened to the spleen cells, he filed suit against Dr Golde and the University of California. Moore claimed, inter alia, an interest in the products developed by using his tissue, on the basis of a tort of ‘conversion’, which gives one dominion and control over personal property against the right of another to control that property so that the tortfeasor may justly be required to pay the other the full value of the property (Moore v. Regents of the University of California 1990).


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[i]ronically, not only did the court reject the Greenberg’s argument that the Canavan gene patent should remain part of the public domain because that was their intent, but instead [it] ruled that it was their bodies and their genes – and not the gene isolated by Dr Matalon – that were in the public domain, free for appropriation by the first researcher who came along and reduced them to private possession. (Rao 2007, 378)

As far as the conversion claim was concerned, the court also held that the plaintiffs did not allege how the hospital’s use of the Canavan Registry was an expressly unauthorized act, and that the plaintiffs failed to allege the circumstances or conditions that were attached to the defendants’ use of the Canavan Registry. The Greenberg court further rejected the plaintiffs’ claims for a continuing right of donors to possess the results of research conducted by the hospital on the material provided by Canavan families, including patented applications, and it reaffirmed their status as ‘donations’. The court stated: … [i]f adopted, the expansive theory would cripple medical research as it would bestow a continuing right for donors to possess the results of any research conducted by the hospital. At the core, these were donations to research without any contemporaneous expectations of return …. (Greenberg 2003, 1075)

As regards the thorny issue of the contribution of the families to the research process and the gene discovery, the court permitted a cause of action for unjust enrichment by recognizing that there existed ‘a continuing research collaboration that involved plaintiffs also investing time and significant resources in the race to isolate the Canavan gene’ [emphasis added] (Greenberg 2003, 1075). As a result, in September 2003, the parties reached a confidential settlement which permitted a research exemption for royalty-free research by institutions and researchers in search for a cure and entitled the Miami Children’s Hospital to continue to license and collect royalty fees for clinical testing by certain licensed laboratories for the Canavan gene mutation (Bernier et al. 2004, 33; Canavan Foundation 2003; Oberdorfer 2004, 365; Rao 2007, 371). A key problem stemming from this case – and related to subsequent cases where the courts have denied acknowledging property interests to the sources of tissue material – is the basis on which this ‘material contribution’ will be assessed. Did the court in the Greenberg case allow the unjust enrichment claim only because the patient families contributed considerable monetary resources to the research? Did it disregard their contribution of biological tissues and related information? How ought the court’s stipulation on ‘investing time and significant resources’ to be analyzed further? What is the extent to which future patients and research participants can have a say in the use of potential future commercial applications of research to which they have contributed materially (Rao 2007, 371; Anderlik and Rothstein 2004, 450; Oberdorfer 2004, 365)?

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This key issue was addressed – albeit in a sui generis fashion discussed below – by another patient advocacy group, PXE International, again in the US, somewhat contemporaneously to the Greenberg developments. PXE International Many patient advocacy groups currently follow the model that PXE International pioneered in establishing representative structures, maintaining member databases, setting up registries, biorepositories, blood and tissue banks, providing research infrastructure, funding and coordinating research, contributing to gene discoveries, testing and clinical trial recruitment – to name a few kinds of their diverse activities (Terry 2007, 158, ft. 7). In 2000, PXE International successfully negotiated intellectual property rights over research done with the tissue samples and the data that PXE members contributed (PXE International website). The PXE patient group is a non-profit patient advocacy organization which represents the interests of families affected by pseudoxanthoma elasticum, a rare genetic disorder affecting elastic tissue and skin cells. PXE provides patient support, funds and coordinates a consortium of research labs, directs a blood and tissue bank and maintains a database of thousands of members worldwide. PXE entered into a contract with researchers, in an attempt to steer research in finding the gene associated with PXE disease. In accordance with the contract agreement, PXE is entitled to ownership rights in any patent application arising from the research and a profit share in any revenue to be generated by such inventions, a right of control ensuring broad and affordable availability of genetic tests, and a right to influence future licensing of the intellectual property (Bovenberg 2004, 7; Gitter 2007, 317). To date, neither party to the contract has challenged its enforceability on the ground that the members do not have a property right in their removed material – as in Moore (as individuals) – and the PXE example has been followed by other patient groups in subsequent years, e.g. Cure Autism Now, Juvenile Diabetes Research Foundation, Alpha-1 Foundation (Gitter 2007, 317; Terry 2007, 159). In the words of one of the protagonists of PXE International: … [e]arly on, [we] knew that there was a need to incentivize research into PXE by leveraging the available resources. It seemed that this would be best achieved by establishing a community, developing a commodity through this community, making the foundation an essential part of the academic enterprise, and aiming towards the industrialization of a treatment or technology, with the goal of improving the lives of affected individuals …. [emphasis added] (Terry 2007, 160)

The initial ‘creation’ of the community was achieved by the use of language that allowed affected family members to share their experiences and no longer


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feel alone in the way that patients with rare disorders can be. The process of becoming engaged was not reduced to the use of informed consent but instead it involved an informal decision-making process tailored to engage with individual patient needs, who in return donated samples and necessary related medical record, health questionnaire and longitudinal data. Their first step was the PXE International Blood and Tissue Bank, then the formation of the PXE International Research Consortium, the creation of memoranda of understanding with scientists, member engagement with bench science as research team members and assistance in gene and gene mutations discovery (Terry 2007, 160). PXE International evolved from the concern of determined parents who acted not only as advocates but also as mentors for advocates for other conditions (Terry 2003, 377). They adapted their practices to the needs of the families they represented, by establishing an active multicultural membership, an international research consortium and internationally networked patient support offices, a patient registry, a biobank, and by actively working together with researchers, eventually to become gene co-discoverers and joint intellectual property inventors (Rajan 2006, 194–6). In late 2003, one of the founders of PXE International during an international conference in Canada advised that the skills required for them to succeed and the strategies which worked best were ‘commitment, strategic planning abilities, organizational skills, ability to understand the ambient milieu [which helped build] a unique international alliance of interest persons’ (Terry 2003, 377). Interesting comparisons can be drawn between the ways in which the Greenbergs and PXE International (the PXE) went about building their communities and shaping their activities respectively. These highlight the differences in the outcomes of their respective activities, especially when considering how each group worked towards acquiring the necessary information, seeking cooperation with members or external partners and pursuing ways to translate ‘their’ research to affordable therapies for their members. Commentators have stated that ‘the Canavan experience [wa]s perhaps an extreme example of what can go wrong with patents and medicine’ (Merz 2002, 111; USA Today 2003; Gorner 2000). Merz quotes the case as a ‘tale of successful research collaboration gone sour’, ‘a bad example of the way not to do it’, highlighting persistent problems in diagnostic tests being tied up against the interests of patients when exclusively licensed. Gorner describes this case as ‘the ultimate nightmare of how a gene patent can be used against the very families who made possible the discovery of the gene’. Certainly the Greenberg case seems to suggest that patient groups should be ‘more aggressive’ in pursuing collaborations with researchers by negotiating and retaining rights, including IP rights, in order to ensure broad and availability of diagnostic tests and therapies (Merz 2002, 111). Was the PXE a unique and ‘miraculous’ international alliance of interested persons, or rather an intelligent consumer management and

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business model (Rajan 2006, 194)? Or is it both? While setting up the PXE International Research Consortium, the PXE advocates agreed memoranda of understanding (MOUs) with researchers which allowed them to work together, without sacrificing funding and publication advantages (Terry 2007, 160–61; Stockdale and Terry 2002, 80; Rajan 2006, 195). The terms of the MOUs were in fact research collaboration agreements and included terms on: • what constitutes acceptable uses of sole and joint data and materials; • the use of particular material transfer agreements (for biological or other relevant materials, chemical compounds and software); • clear authorship and acknowledgement procedures decided well before the research commences and the manuscript is written; • specific timelines for public release of newly generated data and materials; • detailed description of research projects, role and responsibilities of each party; • criteria for intellectual property co-authorship and co-inventorship, payees of patenting costs and future licensing negotiations determined upfront.4 These MOUs were used as platforms to ensure clear understanding of the parties’ commitments and to agree common lines of action. As a result, the rights that the PXE became entitled to included patent ownership rights in applications that arose from that research, profit shares in revenue generated by inventions, and crucially, the rights to ensure and to control broad and affordable availability of genetic tests that might be developed and rights to influence future licensing terms on them (Terry 2007, 160; Bovenberg 2004, 7; Gitter 2007, 317). The PXE did get to be named as co-inventor in the patent which was subsequently obtained for the ABCC6 gene and its mutations that cause PXE (Marshall 2004, 1226; Rose and Novas 2004, 20). Fleisher (2001) discusses that: when the gene for PXE was discovered by researchers at the University of Hawaii … the technology transfer unit at University of Hawaii was initially reluctant to yield patent rights to PXE International …; but as they had previously negotiated the terms and conditions of access to the registry, in addition to Sharon Terry [one of the two PXE International founders] being named as a co-inventor, they were able to work out a process of sharing royalties with the University and a stake in deciding on licensing deals … from [the PXE International] perspective, this [was] a vehicle for ensuring that any resulting medical treatments be affordable and accessible. 4 Terry (2007, 160) describes these in further detail.


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The PXE wanted to secure and control affordable access to therapies that might be developed from their collaboration. In 2000, researchers at the University of Hawaii used samples from the PXE International Blood and Tissue Bank to identify the gene and the PXE engaged in several research projects and funded parts of the process which led to the generation of important data for the identification of the gene. Because the founders of the PXE participated materially in that discovery, they were awarded inventorship and were named co-inventors on the patent (Fleischer 2001; Spier 2001, 3; Smaglik 2000, 821). They assigned their rights to the PXE Foundation, together with the scientists involved in identifying the gene. The PXE considered their organization to be the custodian, or steward of the gene, in direct representation of the interests of the PXE families towards moving from the gene discovery stage to commercialization for diagnostics and therapeutics (Terry 2007, 161l; Spier 2001, 3). As one of the two PXE founders put it, ‘with a gene patent and a myriad of peer-reviewed publications authored, PXE International is in a position to require that the research enterprise serves the paramount stakeholders, individuals with PXE and their families’ (Terry 2003, 377). Interestingly, in pursuing these strategies, the PXE adopted a proprietary language and aggressive negotiation practices, which arguably mirror the way innovation and market relations operate. Patrick Terry contended in 2003 that ‘the US patent law is robust’ and a ‘more than sufficient vehicle for a “rational approach”’, a statement which clashes with views discussed with advocates in the deliberations of the Greenberg case (Terry 2003, 377; cf. Merz 2002, 111; USA Today 2003). The PXE advocates adopted a language that was aware of healthcare financial management strategies. They called their approach a model of ‘disruptive innovation’, that is similar to changes in the marketplace that redefine solutions, ‘pushing to accelerate the research enterprise beyond its usual pace and involving new players, the advocates’ (Terry 2007, 160).5 Patient Control and ‘Entrepreneurship’ A Hybrid Model for Group Rights in Research Several commentators consider the PXE model to imply that PXE and its members have a property right in their biological material (Bovenberg 2004, 16). I understand the PXE model as a hybrid model for advancing research instead. It has adopted aspects of academic models of rigorous science; commercial business (commodification and accountability); strategic mobilization (trust and agility) in establishing and maintaining ongoing cooperation between 5 An online commentator and patent lawyer swiftly called the PXE approach a ‘do-it-yourself patenting’ (Fleischer 2001).

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its partners. The model is innovative in that it led to the establishment of a common infrastructure and mentoring schemes, so as to enable patient groups to initiate and accelerate research, and is a replicable model by many groups, in that context. For example, elements of the PXE International model were successfully incorporated, in the case of CFC International (cardiofaciocutaneous syndrome) in collaboration with the Genetic Alliance BioBank, which eventually led to the stage of establishing clinical trial testing on the Costello syndrome (Terry 2007, 162–3). But why did Canavan fail and why did PXE succeed? The PXE developed strategies to control their interaction with their partners and its outcomes proactively, by learning the market, and by materially contributing to the research discovery process. It is worth stressing that the PXE did not ‘negotiate’ for inventorship, contrary to some bibliographical accounts. The PXE met the inventorship requirement under US Patent Law, which does not allow for negotiations. Inventorship is strictly defined by the patent statute (US Code Title 35), as one ‘who makes a contribution to the subject matter of the claims of the patent’; Sharon Terry obtained the co-inventorship by participating materially in the research (Ducor 2000, 873). Interestingly, in 2003, during a speech at a meeting on benefit sharing at the University in Philadelphia, Sharon Terry stated, that ‘we don’t believe [that] contributions of samples … entitle anybody to inventorship …’ who further confirmed the previous point on why the PXE obtained the joint intellectual property rights with the Hawaiian researchers (Terry 2003, 377). The advocates prepared long term planning strategies early and organized themselves in ways which enabled them to stay informed, and to control their activities at all stages of their engagement with their research ‘partners’; they adopted a communitybased, facilitative discourse together with an entrepreneurial approach. Such approaches have been characterized by recent commentators as novel ways towards culture-building, influence and ‘steering’ (Salamon 2002, 15–16). Some authors have hypothesized that the PXE were in knowledge of the earlier problematic outcomes of the Greenberg experience, but this is not true, according to PXE representatives. The PXE have repeatedly stated that they were not aware of earlier cases when they conceived their own approach to property rights; that they had actually crafted their agreements before the Canavan case surfaced, that they did not know anything about the Canavan activities (Stockdale and Terry 2002, 95–6; Terry 2003, 377). A few years earlier, the Greenbergs had been actively involved in collecting samples and resource building, with combined efforts of Canavan families and support foundations to create a tissue registry and organize community outreach and testing activities. They operated within a more traditional framework, under the assumption that the researchers involved in their project shared common goals with them. They were unfortunate in that they did not discuss and agree these in advance with the researchers they approached; it was more unfortunate that the relevant institutional review boards were not able


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to protect their interests. They did not sign consent forms at the early stage of sample collection between 1987–1994, and it was only upon the families’ request in 1994 that the suggestion for a consent form to be used was given to the researcher, who by then was employed at the Miami Children’s Hospital; the hospital Institutional Research Ethics Board approved the research with an express waiver of informed consent. It is necessary to take these details into account in order to give a more comprehensive view of the case and its particular circumstances. Jon Merz discusses that the Canavan families were ‘uninformed’ and that they became ‘dumbfounded’ when the hospital sought the patent over the genetic test for the Canavan disease (Merz 2002, 112). Arguably, their circumstances might have had a different turn, had they sought to negotiate an agreement, in advance of any research collection, and had the research been conducted accordingly – for example, consent was not sought before collection. In the absence of unambiguous clarification of the law to recognize increasing research participants’ continuing interests in research and its outcomes, the difference between the entrepreneurial model of PXE International and the less informed Canavan families influenced significantly their role-taking and role-making as advocate activists and support networks. It was rather unlucky for the latter that they were hardworking yet uninformed agents conflicting with corporate university managers, whilst the former (the PXE) succeeded to engage in fruitful collaborations with researchers as proactive and informed patient-managers. It is my belief that the legal system should not leave such matters to ‘luck’ or to the market alone. The fact that the PXE model operated, to some considerable degree, on the basis of business and commercial strategies might signal that group participants are starting to realize that the traditional notion of gratuitous altruistic participation in research needs to change. The fact that the PXE succeeded in safeguarding and promoting the interests of its members made this model a basis for the activities of other groups. It is imaginable that such groups could increasingly act similarly to the ways in which business and commercial entities seek to establish licensing policies. But then, regulatory concerns arise in that patient advocacy groups might exercise control over ‘their’ research results to maximize their own benefit, and limit access to these results for people suffering from other disorders. Such concerns have been voiced when patient advocacy groups lobby for funding for the National Institutes of Health in the US (Gitter 2007, 323; Bovenberg 2004, 16). They expose a ‘limit of governance’ in current developments in genomics. The PXE asserted that their goals with regard to patenting and licensing are to ‘facilitate useful, timely treatments and to make all tests and treatments accessible and affordable’ (Stockdale and Terry 2002, 95). They have stated that they will ‘resist bettering of their own fortunes at the expense of patients suffering from other diseases’. It is not clear whether this may in the future clash with their prerogative to ‘insist upon licensing deals that would maximize the

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access of PXE patients to a future diagnostic test or treatment’. The argument could go on and on, until ‘we might all end up having to swap licenses and set off royalty payment before consulting our physician’, as Bovenberg (2004, 16) eloquently puts it. Still, in view of the approach that the PXE is advocating at present, a good argument in their favour is that they already managed their way through their own mini-anticommons, and they already faced the problem successfully. They have avoided wasting their commonly held scarce resource – that is, intellectual property rights on gene tests developed through their collaboration with researchers – by under-consuming it when compared with a ‘social optimum’ (Heller and Eisenberg 1998, 698–701). To clarify, the notion of the anticommons was developed as a mirror image of commons property by Heller and Eisenberg. The tragedy of the commons occurs when multiple owners are given the privilege to use a resource with no one having the right to exclude another, and the resource gets overused and exhausted. The tragedy of the anticommons occurs in situations where multiple owners hold rights of exclusion in a scarce resource and they can block its use; in the field of biomedical research with the proliferation of patents on gene sequences and database rights in genomic databases, rights of exclusion bear the danger of blocking, restricting or delaying access to healthcare innovations. Political economists and anthropologists who study modern shifts in the dynamics of postgenomic economies and the generation of biovalue have been developing theories about the agency and impact of advocacy groups as innovators; they refer to advocacy stories as ‘stories of miraculous therapeutic intervention’, facilitated by the construction of new ‘networked biosocial communities’, through forces of ‘consumer genomic revolution’ (Rajan 2006, 193–4; Rose and Novas 2004, 20). From a legal viewpoint, despite the fact that such organizations accelerate research and therapies for rare diseases considerably, there is some way to go towards developing models that can help solve regulatory problems in controlling the use of resources, with long term certainty. These problems include questions on what would apply to groups who do not have the resources, information or capability to upgrade themselves as joint inventors or equivalent collaborators. The Greenberg case and the PXE model are good examples in analysing current views on whether groups can have control of resources, the degree of control that groups should have, and whether the basis of their claims can legitimately lie on property (including property by contract). The challenge of regulating the interests of all relevant agents, i.e. patients, families, researchers, research funders, investors, clinicians, society, has not yet been met so as to eliminate potential conflicts. The PXE model agreement has not been challenged in court so far. If the agreement is ever challenged in the future on the ground that the members do not have a property right in their removed material, it would be intriguing to see what the US courts would adjudicate on


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the group’s entitlement to control and to profit from uses of that material or subsequent research derived from it. One thus wonders whether contractual agreements and property rights are the optimal way to go about protecting group interests, and solving persistent control dilemmas, as conflicts of such nature are likely to increase. This is why novel approaches and modes of governance are needed, in order both to meet the needs and values of non-governmental stakeholders such as patient advocates, but also to reconcile these with state ability to exert some degree of control over their activities. A New Basis for Group Protections: Focus on Relationships A conceptual basis is needed for the development of viable legal group protections instead of compartmentalized and/or hybrid approaches. While it is important to maintain awareness of the specific needs and capabilities of particular groups, this cannot happen in isolation of the articulation of general principles to enable a consistent approach in the regulation of the management of human biological material in research. It is only through the development of conceptual frameworks that the need for certainty, fairness and cooperation can be accommodated. The previous sections discussed how property and contractual agreements are not the optimal means to generate conceptual solutions but rather technical tools to be applied in respect of the will of the parties. Participants as parties are traditionally viewed primarily as individual agents rather than members of a whole. In current developments, agents tend to act on the basis of the logic of ‘let the market decide’, but, the market does not take personal, cultural and ethical considerations into account when focusing on commercial, proprietary managerial models. One could argue that the story of the Greenberg case was an example of the failure of the market to provide an equitable answer in the conflict that ensued. The proprietary approach of the hospital managers to the conflict may have been inadvertently enabled by the ignorance (or naivety) of participants, but was also furthered by the absence of a principled legal backbone to protect participant contributors. Would the collaboration have had a happier end for the Greenbergs, had they negotiated in advance? Maybe yes but maybe not. There is no precedent of a test case, the influence of the Moore v. Regents of the University of California case aside, nor can one predict with safety how the PXE model may last in the future, especially if a party challenges advocates with a lawsuit – in this or in any other case of patient groups under the PXE model. An important difference to consider in this context is the difference between models based on contract and models based on membership or a common connection. There exists a conceptual and practical distinction between the interaction of contractual parties who act as diverse parties with different ends, and cooperation on the basis of membership created in line with a common

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connection and common pursuit of goals, as part of ongoing relationships (Smith 2001, 176). According to philosophical work on group membership theory, duties of connection derive from one being part of something with which they partly identify, e.g. one’s family, profession, nation, and within which they develop and define oneself, by sharing common assumptions and beliefs over time; in duties of ‘contract’ on the other hand, there is no intrinsic connection between contracting parties (Smith 2001, 176). In the advocacy cases examined above, the differences seem blurred. For example, the reliance of the PXE on negotiation may render their model as a prima facie contractual model, but, closer consideration reveals that their model could also be understood as a model of connection. The PXE advocates strategically sought to define their roles early in their partnership with researchers; but, at the same time, the PXE helped to bring patients to meetings with lab scientists, and vice versa, they invited researchers to patient family meetings. This reportedly gave scientists the opportunity to understand more deeply the reasons for their work and it enhanced their motivation to work on PXE (Terry 2007, 160). On this basis, it is reasonable to argue that PXE advocates used narratives of community-building, which, in turn, are genuine elements of the membership (or common connection) theory. These strategies involved emotional commitment-building towards researchers, early on and during their collaboration with advocates. Such communitybuilding narratives are an intrinsic part of strategies used in the advocacy hybrid approach. They aim precisely to strengthen partners’ attitudes towards a common-minded ethos and common pursuit. This phenomenon shows an interest and shift in emphasis towards defining not only the roles of the parties involved in research, but the nature of their relationship. Current approaches in the regulation of the use of human biological materials in research are not foreign to discourses of community-building, albeit in the other way round. For example, existing UK guidance on the use of human biological materials in research proposes a soft version of ‘connectedness’, in current references to ‘altruism’ and ‘genetic solidarity’, as central to understanding the motivations for research participation (Human Genetics Commission 2002). Parallel to the fact that these concepts in favour of free donation are being forwarded by advisory bodies, the courts tend to ignore notions of patient synergy and empowerment by contrasting them with concerns about no hindrance of medical research. The irony with the Greenberg case is that the patients were the ones who wanted more research done in the public domain, and the University the one who wanted to hinder such access (Rao 2007, 371). In light of these ambiguities, it is therefore paramount to consider novel ways to understand the nature of the research relationship between group members and researchers and define how this relationship could be viewed in law.


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The Relationship Between Groups and Researchers as a Contract: Advantages and Limitations There are at least two ways to describe the kinds of responsibilities undertaken by groups and researchers in group research, if their relationship is bound by contract. One way is to consider ‘contract’ as a formal, binding, legal agreement that warrants the performance of contractual conditions, according to the will and mutual undertaking of obligations for the parties. The other is to view it as social and moral metaphor which denotes the need for respect of each other’s interests. In this chapter, I consider primarily the merits of the former, especially since contractual private agreements between groups and researchers already exist in the case of patients groups with individual researchers. I am fundamentally interested in the potential implications of the hybrid approach adopted by PXE via culture-building, steering and persuasion, for the development of new models of group protections. This approach arguably lends support to theories about impact of patient groups as stakeholders in establishing networks and changing boundaries in the governance of the public and private divide (Kjaer 2004; Bache 2003). Private arrangements such as advocacy agreements seek to protect group interests in monitoring the use of group samples and data, subsequent dissemination of research findings, negotiating research-related benefits, licensing royalties from future research, reduced or free access to therapeutic products developed that may be beneficial to group members, agreed via material transfer agreements or memoranda of understanding (Terry et al. 2007, 157). These do not provide protections about respect to cultural values and views, or fears against anti-discrimination, but they allow the clarification of parties’ expectations and rights ex ante, and are dependant on the private will of the parties (Anderlik and Rothstein 2004, 450; Oberdorfer 2004, 389). Practical advantages of these contractual approaches in protecting group interests are that they incorporate elements of free will, mutual responsibility, and legal commitment. The groups can specify what researchers can or cannot do with the transferred tissue samples, data and research outcomes. In the absence of legal recognition of property rights to groups as tissue sources, there is, at first instance, an automatic appeal for groups to consider contracts in order to negotiate terms with researchers and research institutions, for example about the commercial and scientific uses of the proposed research, prior to or during the research. I mentioned earlier that the rise of patient advocacy is an important phenomenon in genomic innovation which draws on the strong tradition of patient advocacy activities since the 1970s (Dresser 2001; Epstein 1995; Merz et al. 2002; Novas 2006; Parthasarathy 2004; Rajan 2006). In the absence of other protections, today patient advocates increasingly seek to negotiate contracts in gene-discovery and drug-related research, and, in market-terms, they build their bargaining power by amassing biological and financial

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resources. I have discussed that their contribution is not limited to these latter two factors even if these aspects are the two main kinds of contribution often highlighted by legal scholars. With the successful agreement between PXE International representatives and University of Hawaii researchers as a prime example, these initiatives rely on private written agreements, usually before researchers gain access to samples, in order to forward group goals. These have advantages in that contractual negotiations can help to avoid disputes which might arise in the absence of an agreement. But significant caveats emerge when groups rely on private means to negotiate and exert substantial control over the terms of research. For example, these agreements are often confidential and it is difficult to check whether the terms agreed are equitable (Bellivier and Noiville 2006). Contract agreements do not bind third parties, and it is rather uncertain whether they would be deemed enforceable, if challenged in court. For example, in the PXE case, the contract is only binding between the Terrys and the university where the researcher who discovered the gene worked, and if challenged, it could be found void either on the basis of no consideration, or as contrary to public policy. Arti Rao (2007, 371) makes exactly the same point, in her recent commentary on the Moore, Greenberg, and Catalona cases, that, if challenged, these contracts would possibly not be enforceable either because of lack of legal basis (body outside commerce, no financial gain on one’s body) or because they may be deemed as curtailing research – and against public interest. Furthermore, it is not always the case that contractual ability to negotiate per se offers real advantage, in particular where the parties are largely unequal in their negotiating capacity, or in how clearly defined they are. Contract models do not offer protections against risks of unequal bargains, if one party is in difficulty (Rao 2007, 379; Tvedt 2006, 192). This fact could present major obstacles for groups situated in developing countries. Moreover, the fact that contract agreements do not bind third parties is a further significant problem since transfer of material to third parties would fall under a legal gap. This gap could perhaps be remedied by strategies such as including clauses to limit transfer rights to third parties, or allowing transfers only if third parties agree to the same conditions as the first recipient of group material. Yet, enforcement options are limited, a fact which can have a chilling effect on possible negotiations (Tvedt 2006, 192–3). In view of these observations, a key question in considering the suitability of contract models is whether terms and conditions should be left to the parties alone to define or whether these should be controlled by the law. Can contracts enhance collaborative relationships between groups and researchers? Can they provide means of evaluation and long-term cooperation? One may wish to wonder whether it is desirable to use contracts as a better way to achieve group goals, given that contractual formulations can often be imaginative – compared to current research ethics protections. I have argued here and elsewhere that it is not possible to use contracts to such ends because


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of problems with potential imbalance and detrimental effects in securing trust in group-researcher interactions (Kanellopoulou 2008). There are those who argue that contractual agreements can offer new ideas on what groups want and possibly serve as guides in developing new laws; for example, Bellivier and Noiville charmingly call contracts the ‘labs of the law’ – ‘les contrats comme laboratoires de la loi’ (Bellivier and Noiville 2006). The difficulties with potential imbalance in research interactions do not escape recent commentators. In considering that the contractual ability of groups depends on groups’ position in the market, Arti Rao (2007, 379) argues that ‘success in these cases depends on parties’ common goals to share profits privately’. She suggests that patient advocacy activities merely reproduce the property paradigm, and that contract and property are two sides of the same coin. This is so because by taking charge of research activities on a particular gene, patient groups replicate the imbalance that existed originally between them and researchers, which will then be mirrored between them and other groups for whom the gene is important. Rao’s analysis echoes previous criticisms that such initiatives essentially privatize the redistribution of research resources (Hayden 2007, 744). Yet it is imperative to stress that advocacy objectives primarily concentrate on ways to negotiate better control in research, in order to secure accessibility and affordability of future products, and not to produce financial gain. This fact reiterates that the pervasive question about control in group research is not ownership per se, but rather, control over the use of research tissue samples, data, and results, in accordance with group views and needs – interests which arguably can instead be defined as non-proprietary (Hardcastle 2007). In sum, existing contractual models in advocacy arrangements could present problems, have limitations, and do not address broader questions on how to deal with plurality of conflicting views among several groups. These questions have arisen in debates in the US, while seeking to determine best ways to allocate funding for advocacy activities in research on genetic diseases (Dresser 1999). The acknowledgment of their limitations warrants reflection on developing governance alternatives in this area of genomic research. These can be considerations for central oversight mechanisms, universal standards for research agreements, or novel flexible approaches. Conclusion This chapter identified enduring challenges in the governance of advocacy and group activities in research and it considered the advantages and pitfalls of current solutions for their regulation. These include models of self-help governance, in the form of contractual agreements and property claims which seek to establish ongoing control for advocates as long term stakeholders in research. Whilst these models help broaden thinking about innovative

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regulatory options and mechanisms, their assessment reveals limitations, especially in that they do not help solve broader questions of equitable governance in research. Self-help models may work in some instances but it is uncertain whether they would be enforced by courts in case of conflict. They have been criticized as replicating the same exclusive effects as property models do, and as not being the best way to protect groups’ interests long term. By assessing current jurisprudential developments in advocacy engagement and management of biomedical research, this chapter sought to establish that advocates operate as research facilitators and innovators. Their study offers a strong case for developing interactive model institutional approaches which are not only realistic about the extent of leverage that advocacy stakeholders can exert, but also retain elements of hierarchy and control within the governmentgovernance continuum (Lyall and Tait 2005; Kjaer 2004; Kooiman 1993). Calls for a more systematic way to develop new principles and interactive mechanisms in order to institutionalize effective governance models for group research continue to emerge in recent years. There is increasing support that there can be no meaningful empowerment for group research participants if regulatory and policy systems do not take account of their interests and diverse cultural and economic contexts wherein group research takes place. This view warrants the development of new approaches in order to challenge, clarify and refine current norms about how law views the relationship between groups and researchers. A helpful way for law to view the relationship between groups and researchers and to broaden current thinking about the role of group as research stakeholders is to assess the meaning of, and conditions for, meaningful empowerment in group research. I have discussed elsewhere in detail new criteria that could be developed to re-evaluate group participation in research not as a gratuitous transfer with no expectation of return (free gift), but instead as a conditional gift, dependant on a nexus of reciprocal returns of favours between mutually engaged, collaborating parties (Kanellopoulou 2008). Such an approach can provide a new ground for developing principled group protections, in recognition of the dynamic nature of group-researcher engagement, with respect to group interests and values, and in proportion to the nature of their contribution in research. References Adams, J.N. and Brownsword, R. (2000), Understanding Contract Law (London: Sweet and Maxwell). Ahrne, G. and Brunsson, N. (2004), ‘Soft Law Regulation from an Organizational Perspective’, in Mörth, U. (ed.), Soft Law in Governance and Regulation – An Interdisciplinary Analysis (Cheltenham: Edward Elgar Publishing Ltd).


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Anderlik, M.R. and Rothstein, M.A (2003), ‘Canavan Decision Favors Researchers over Families’, Journal of Law, Medicine and Ethics 31:3, 450–54. Bache, I. (2003), ‘Governing through Governance: Education Policy Control under New Labour’, Political Studies 51, 300–14. Bellivier, F. and Noiville, C. (2006), Contrats et Vivant – Le Droit de la Circulation des Ressources Biologiques (Paris: LGDJ). Bernier, L. et al. (2004), WHO Literature Review on Access to Genetic Technologies and Services: View from Developing Countries (Montreal: McGill Centre for Intellectual Property Policy). Bovenberg, J.A. (2004), ‘Inalienably Yours? The New Case for an Inalienable Property Right in Human Biological Material: Empowerment of Sample Donors or a Recipe for a Tragic Anti-Commons?’ SCRIPT-ed 1:4, . Boyd, K.M. et al. (1997), The New Dictionary of Medical Ethics (London: BMJ Publishing Group). Chadwick, R. and Berg, K. (2001), ‘Solidarity and Equity: New Ethical Frameworks for Genetic Databases’, Nature Reviews Genetics 2:4, 318–21. Dresser, R. (2001), When Science Offers Salvation: Patient Advocacy and Research Ethics (New York: Oxford University Press). Dresser, R. (1999), ‘Public Advocacy and Allocation of Federal Funds in Biomedical Research’, The Milbank Quarterly 77:2, 257–74. Ducor, P. (2000), ‘Intellectual Property: Coauthorship and Coinventorship’, Science 289 (11 August): 5481, 873–5. Epstein, S. (1995), ‘The construction of lay expertise: AIDS activism and the forging of credibility in the reform of clinical trials’, Science, Technology and Human Values 20:4, 408–37. Fleischer, M., ‘Patent Thyself’, The American Lawyer [website] (updated 21 June 2001), , last accessed 19 March 2008. ‘Genetic Alliance’, . Gitter, D. (2007), ‘Resolving the Open Source Paradox in Biotechnology: A Proposal for a Revised Open Source Policy for Publicly Funded Genomic Databases’, Houston Law Review 43:7, 1–69. Gorner, P. (2000), ‘Parents Suing over Patenting of Genetic Test’, The Chicago Tribune [website] (updated 19 November 2000), , last accessed 27 March 2008. Greenberg v. Miami Children’s Hospital Research Institute, Inc. (2003), 264 F. Supp. 2d 1064 (S.D. Fla.). Hardcastle, R. (2007), Law and the Human Body: Property Rights, Ownership and Control (Oxford: Hart Publishing). Hayden, C. (2007), ‘Taking as Giving: Bioscience, exchange and the politics of benefit-sharing’, Social Studies of Science 37:5, 729–58.

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Heller, M.A. and Eisenberg, R.S. (1998), ‘Can Patents Deter Innovation? The Anticommons in Biomedical Research’, Science 280:5364 (1 May), 698–701. Human Genetics Commission (2002), Inside Information: Balancing Interests in the Use of Personal Data (WHO). Kanellopoulou, N. (2008), ‘Group Rights in Biolaw – A Model Approach’, PhD thesis (University of Edinburgh). Kjaer, A.M. (2004), Governance (Cambridge: Polity Press). Knoppers, B.M. (ed.) (2003), Populations and Genetics: Legal and SocioEthical Perspectives (Leiden: Martinus Nijhoff Publishers). Knoppers, B.M. (2000), ‘Population Genetics and Benefit Sharing’ Community Genetics 3:4, 212–14. Kooiman, J. (1993), Modern Governance – New Government-Society Interactions (London: Sage Publications). Lyall, C., Papaioannou, T. and Smith, J. (2009), ‘Introduction: New Governance Tools for New Technologies’, in Lyall, C., Papaioannou, T. and Smith, J. (eds) The Limits to Governance: The Challenge of Policy-making for the Life Sciences (Aldershot: Ashgate). Lyall, C. and Tait, J. (2005), ‘A New Mode of Governance for Science, Technology, Risk and the Environment?’, in Lyall, C. and Tait, J. (eds) New Modes of Governance. Developing an Integrated Policy Approach to Science, Technology, Risk and the Environment (Aldershot: Ashgate). Marshall, E. (2004), ‘Patient Advocate Named Co-inventor on Patent for the PXE Disease Gene’, Science 305:5688, 1226. Mason, K. and Laurie, G. (2006), Mason and McCall Smith’s Law and Medical Ethics (Oxford: Oxford University Press). McBryde, W.W. (2001), The Law of Contract in Scotland (Edinburgh: W. Green). Merz, J.F. (2002), ‘Discoveries: Are There Limits on What May be Patented?’, in Magnus, D. (ed.) Who Owns Life? (Amherst, NY: Prometheus Books). Merz, J.F. et al. (2002), ‘Protecting Subjects’ Interests in Genetics Research’, American Journal of Human Genetics 70:4, 965–71. Moore v. Regents of the University of California, 793 P. 2d 479, 271 Cal. 146 (1990), 490. Novas, C. (2006), ‘The Political Economy of Hope: Patients’ Organizations, Science and Biovalue’, BioSocieties 1:3, 289–305. Oberdorfer, K.L.J. (2004), ‘The Lessons of Greenberg: Informed Consent and the Protection of Tissue Sources’ Research Interests’, Georgetown Law Journal 93:1, 365–94. Parthasarathy, S. (2004), ‘Regulating Risk: Defining Genetic Privacy in the United States and Britain’, Science, Technology and Human Values 29:3, 3 32–52. Pioneer Hi-Bred v. Holden Foundation (1987), WL 341211 (S.D. Iowa, 30 October 1987), aff’d, 35 F.3d 1226 (8th Cir.1994).


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Rajan, K.S. (2006), Biocapital – The Construction of Postgenomic Life (Durham, NC and London: Duke University Press). Rao, A. (2007), ‘Genes and Spleens: Property, Contract, or Privacy Rights in the Human Body?’, Journal of Law, Medicine and Ethics 35:3, 371–82. Rose, N. and Novas, C. (2004), ‘Biological Citizenship’, in Ong, A. and Collier, S. (eds) Global Assemblages: Technology, Politics and Ethics as Anthropological Problems (Oxford: Blackwell Publishers). Salamon, L.M. (2002), ‘The New Governance and the Tools of Public Action: An Introduction’, in Salamon, L.M. (ed.) The Tools of Government (New York: Oxford University Press). Sistare, C. et al. (2001), Groups and Group Rights (Lawrence, KS: University Press of Kansas). Smaglik, (2000), ‘Tissue donors use their influence in deal over gene patent terms’, Nature 407: 6806, 821. Smith, P. (2001), ‘Duties of Group Membership: Justice as Reciprocity and Liberal Democratic Institutions’, in Sistare, C. et al. (eds). Spier, R. (2001), ‘Genes in Court’, Science and Engineering Ethics 7:1, 3–6. Stockdale, A. and Terry, S.F. (2002), ‘Advocacy Groups and the New Genetics’, in Alper, J.S. et al. (eds), The Double-Edged Helix: Social Implications of Genetics in a Diverse Society (Baltimore, MD and London: The Johns Hopkins University Press). Terry, S. et al. (2007), ‘Advocacy Groups as Research Organizations: The PXE International Example’, Nature Reviews Genetics 8:2, 157–64. Terry, P. (2003), ‘PXE International: Harnessing Intellectual Property Law for Benefit-sharing’, in Knoppers, B.M. (ed.), Populations and Genetics: Legal and Socio-Ethical Perspectives (Leiden: Martinus Nijhoff Publishers). Tvedt, M.W. (2006), ‘Elements for Legislation in User Countries to Meet the Fair and Equitable Benefit-sharing Commitment’, The Journal of World Intellectual Property 9:2, 189–212. USA Today [website] (updated 6 May 2003), ‘Group Can Sue over Gene Researcher’s Patent on Testing’, , last accessed 19 March 2008. Weijer, C. (2000), ‘Benefit-sharing and Other Protections for Communities in Genetic Research’, Clinical Genetics 58:5, 367–8.


Chapter 10

Non-governmental Limits: Governing Biotechnology from Europe to Africa Matthew Harsh

Introduction The African Agricultural Technology Foundation (AATF), a non-governmental organization (NGO), recently announced that it is heading a partnership to develop Water Efficient Maize for Africa (AATF 2008). Funded by US$47 million from the Bill and Melinda Gates Foundation and the Howard G. Buffet Foundation, the project will bring together public research institutes and the private company, Monsanto, and will utilize biotechnological techniques including genetic modification (GM). Such public-private partnerships receive attention because of how they are changing the institutional context and funding structures of research (Clark et al. 2007). However, less attention has been paid to the fact that NGOs are spearheading many of these partnerships, and that this entails new roles for NGOs in terms of biotechnology. NGOs have perhaps acquired a greater global reputation for resisting biotechnology as opposed to leading its development. Largely this is due to European NGOs prominently campaigning against the importation and development of GM crops (Murphy and Levidow 2006; Schurman 2004). NGOs in Africa also campaign against biotechnology. Recently these efforts have increased and broadened; NGO actions are now linked to policy processes, trade and research. For instance, in May 2007 the Economic Community of West African States met in Ghana (Africast 2007) and agreed on a biotechnology plan for the region. This plan was quickly rejected in a press release by some NGOs (Haruna 2007). In another recent example, NGOs alleged that GM maize was illegally imported into Kenya, in an effort to lobby against biotechnology (see Mbaria 2008). In countries where genetically modified organisms (GMOs) are being developed, NGOs often campaign against specific trials, such as GM cotton trials in South Africa (African Centre for Biosafety 2008). Most NGOs, regardless of their stance towards biotechnology, work with the media, politicians and, importantly, farmers to spread awareness and disseminate information about biotechnology. For some NGOs, sharing information across Africa is a core component of their work (ABSF 2007; ISAAA 2006). Location and national identity are also important operational

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resources. While most of the donor-funded biotechnology networks have an international focus, the NGOs which head these networks are physically based in a given African country and have staff members from that country. NGOs, and individuals working for them, can therefore influence national policies about biotechnology and the development of regulatory systems in that country. NGOs are clearly playing new and significant roles in making decisions about how biotechnology will be developed in Africa. In line with the theme of this volume, this chapter will look at these roles through the lens of governance and its limits. A starting point is a meaning of governance common in Europe: governance as ‘co-operative means to deal with common problems’ (Levidow 2007, 22). Through analysis of NGO involvement in biotechnology, the chapter examines the limits of cooperation and of problem framing in governance. The chapter focuses on agricultural biotechnology and asks: How are NGOs involved in collective and participatory activities related to decisions about biotechnology? How are NGOs involved in framing problems about biotechnology and in putting forward solutions to these problems? The main case study comes from Kenya, a country which hosts the headquarters of many international NGOs, research centres, and initiatives dealing with biotechnology in Africa. The chapter argues that there is a paradox involving NGOs and the governance of biotechnology. Although there has been much NGO involvement in decisions about biotechnology in countries such as Kenya – much of it explicitly aimed at facilitating broad cooperation and participation – these efforts have not made decisions about biotechnology more democratic or accountable. Through policy trends in the North and South,1 NGOs have not only become charged with taking lead roles in participatory activities, they have become almost synonymous with notions of collectivity and representation of marginalized segments of society. With respect to biotechnology in Africa, NGOs are partners that organize and invite actors to participatory workshops. Such workshops are a core component of various donor-sponsored networks and partnerships, including both those developing technologies and those developing regulatory systems. NGOs are also influential in framing problems and solutions regarding biotechnology. They help to put forward the notion that biotechnology, via sound science, is an imperative for food security and economic growth. Though the context is different in the North and South, complex relationships between social, ethical, legal and economic issues inherent in biotechnology-based interventions, are often glossed over, or reduced to debates about safety in participatory exercises in both Europe and Africa. 1 Acknowledging diversity within these regions, the North is referred to as shorthand for Europe and North America, and the South as shorthand for South America, Asia, and Africa.

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Through NGO involvement in biotechnology, problem-framing and collectivity are inexorably linked. The scientific framing of problems circulates through major biotechnology networks and partnerships, along with connected scientific expertise and resources. This often creates serious issues concerning disparities in influence and access to decisions. Despite participatory activities, actors without access to resources or those unable to voice their concerns about biotechnology in scientific terms or parlance, remain outside of core networks and outside of decisions. In the conclusion, the chapter turns to specific critiques of NGO participation and governance from the North and South surrounding the themes of access, legitimacy and de-politicization. Given these critiques, it argues for an approach that focuses on decision-making as it actually occurs, or governance ‘in action’. In this way, we can explore specific ways that northern and southern debates about biotechnology are connected, and elucidate the limits of actors, particularly non-governmental actors. NGOs and Collectivity How did NGOs2 come to be seen as ‘valid’ actors that should participate in decisions about the development of biotechnology? Much of the answer to this question is rooted in policy trends surrounding governance in the North and South. Through these trends, NGOs have become collective enterprises: organizations seen as embodying participatory values and representing citizens whose voices would otherwise remain unheard. In discussions about ‘new modes of governance’ originating in Europe,3 ‘third sector’ actors are meant to play key roles vis-à-vis the private sector: ‘[m] ost would accept that the term “governance” refers essentially to the increased role of non-government actors in policy-making’ (Lyall, Papaioannou and Smith in Chapter 1). ‘Non-government’ can be taken to refer to the private sector as well as to NGOs, but it is the relationship between the two within governance that is particularly important. In Europe, the shift to governance 2 The term NGO can be used to describe a wide variety of organizations. For instance, NGOs can be classified in terms of scale (i.e. community-based or grassroots organizations, national NGOs, international NGOs); in terms of degree of autonomy from the state; in terms of whether or not they are membership-based; or in terms of where the NGO’s headquarters is located (in the North or South), to name but a few (Fisher 1997). When a specific organization is referred to as an NGO in this chapter, it is because the organization has given itself that label. 3 As stated in Chapter 1, the central idea here is that in a shift from government to governance, the state is now only one of many actors involved in policy-making (Hajer and Wagenaar 2003; Jessop 1998). Thus in new modes of governance, policymaking involves cooperation and collective negotiation between many types of public and private actors.

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has fostered a particular mistrust amongst citizens. Governance, some argue, has allowed the private sector to have too much influence in policy-making at the cost of the consumer or citizen interests (Levidow 2007, 23–4). Not denying that NGOs have their own agendas, NGOs are sometimes seen as a counterbalance to industry (specifically for biotechnology as discussed more below). Furthermore, whereby governance can be seen as ‘a pattern of rule characterized by networks that connect civil society and the state’ (Bevir et al. 2003a, quoted in Chapter 1), NGOs somehow provide those connections to civil society. While civil society is a problematic term,4 in the European sense of governance, it is an entity tied to NGOs and provides a counterbalance to private interests. In Africa, policy trends about governance and participation also create important roles for NGOs. In the 1980s, NGOs became prominent actors in the South and received significant increases in donor funding as part of the so-called ‘rise of NGOs’ (Edwards and Hulme 1992).5 Because of their perceived closeness to the poor and marginalized, NGOs could more efficiently deliver services compared to undemocratic or corrupt states; NGOs offered a ‘comparative advantage’ (Fowler 1988). Subsequently in the 1990s, NGOs became seen as representatives of, or even embodiments of, civil society whose job it was to provide or enhance national democracy (Diamond 1994). NGOs accomplished this through: creating ways of articulating, aggregating and representing interests outside of political parties, especially at the local level; mitigating conflict through cross-cutting, or overlapping, interest; recruiting and training political leaders; questioning and reforming existing democratic institutions and procedures; [and] disseminating information. (Diamond 1994 quoted in Hyden 1997, 8)

Through both democratization and service delivery roles, NGOs embodied a combination of liberal democratic politics and neoliberal economic reforms (Robinson 1993). In the late 1990s, ideas about governance – different from those in Europe – became prominent in the South and also flagged roles for NGOs. In Africa donors discuss ‘Good Governance’. Good governance has become a system of metrics to measure corruption and accountability of states. Governance is thus a gatekeeper for the flow of aid to a country: if governance reform is insufficient, aid from the International Monetary Fund and World Bank

4 The literature on civil society is vast and connected political economic debates go back centuries (see Cohen and Arato 1992). 5 NGOs have been active in developing countries since long before the 1980s, see Lewis (2005) for an account of this little-discussed history.


can cease.6 Because of their historical association with representation of the rural poor and as embodiments of civil society, NGOs must be partners in any ‘good’ governance reforms.7 This marks a departure from previous antagonistic relationships between NGOs and states. Indeed, NGOs have taken on many new roles in policy realms and beyond (Opoku-Mensah and Lewis 2006). Partnerships with NGOs, and even the notion of governance itself, became an institutionalized formula or a technical ‘fix’ for a non-functioning aid system (Crewe and Harrison 1998). These policy trends in the North and South have bolstered NGOs working with biotechnology in Africa, and allowed them to be active in many new areas. For example, NGO involvement in donor-funded biotechnology development networks stems from the participatory history of NGOs. Within these networks, NGOs are meant to leverage their connections with farmers, with community organizations and even with the state. These connections are used to facilitate workshops or stakeholder meetings related to biotechnology, and to represent the needs of communities at those meetings. Within publicprivate partnerships, NGOs are meant to be brokers between local knowledge and scientific knowledge and can become hubs of innovative systems (Clark et al. 2003).8 Perceived ties to ‘the local’ are resources that generate further funding from donors; NGOs working within public-private partnerships are usually well funded. These NGOs are therefore often able to participate in regulatory developments or in decisions about specific technology approvals within the country where they are based. These same policy trends have also aided NGOs in finding ways to resist biotechnologies in Africa. NGOs opposing biotechnology also claim that they represent local farmers and local interests. For example, NGOs have brought farmers to press conferences where farmers publicly sign declarations stating that GM crops are inappropriate to local practices or too expensive to be accessible to local farmers (KESSFF 2004). While local connections are important for NGOs in establishing themselves as collective or participatory agents, international linkages are also important. African NGOs resisting biotechnology work with European NGOs such as Greenpeace and GRAIN (GRAIN 2008; Greenpeace 2008). NGOs developing technologies have international research linkages. These kinds of

6 For example, international aid has ceased on account of corruption in recent history in Kenya (Holmquist 2001). 7 Despite donor statements about disappointments about NGOs not meeting expectations in service delivery or democratization, there are still very significant amounts of donor funds being channelled to NGOs (Agg 2006). 8 Research on NGO-facilitated agricultural research goes back at least a few decades (see the chapters by Kesseba, Chambers and Farrington and Martin in Wellard 1993).

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international connections are key resources for NGOs in their efforts to frame debates about biotechnology. Framing Biotechnological Problems How have NGOs been involved in voicing motivations for biotechnology and in framing problems related to biotechnology? How have they been involved in putting forward solutions to these problems? Again, some comparison between the North and the South is helpful in addressing these issues. In terms of the dominant way in which problems are framed, the governance of biotechnology is similar when looking from Europe to Africa. However, the most visible NGOs in the South are on the opposite side of the biotechnology debate as those in the North. In the European Union at the level of transnational policies, biotechnology is generally put forward for neoliberal and technologically deterministic reasons. Biotechnology is presented as an objective imperative necessary for Europe to compete economically and grow in a globalizing world, and thus reap social benefits. Debates and decisions about biotechnology, and specifically genetic modification, are framed around minimizing risk (and sometimes also maximizing benefits) of biotechnology. Furthermore, utilizing science-based evidence is seen as the mechanism to minimize risk (Levidow 2007). In his study of technological assessment activities in several European countries, Levidow (ibid.) shows that despite technology assessment activities, fundamental conflict about values in agricultural innovation9 – diverse economic, ethical, legal, social, and environmental issues surrounding the whole agri-food system – are reduced to managerial decisions about appropriate levels of safety for biotechnology. Rayner, writing just before the UK’s GM Nation? public consultation in 2003, makes a similar argument: Almost inevitably, where new techniques of public participation are implemented in a political culture of science- and evidence-based expertise, they are forced to permit science to set the stage. For example, in Britain, citizens are about to be consulted about ‘genetically modified crops’ rather than about ‘food and the countryside’. (Rayner 2003, 168)

NGOs resisting biotechnology in Europe frame problems differently. They look at biotechnology more broadly and in less scientific terms, for example drawing on social and cultural notions of ‘sustainability’. In general, and in line with the principles of governance, European NGOs have been able to participate in decisions about biotechnology, or at least in consultation exercises. 9 For a further discussion about the role of values in a different context – that of tissue databases – see Laurie, Bruce and Lyall, Chapter 3.


The difficulty arises, however, when the alternative ways in which NGOs frame issues about biotechnology have to be compressed and transformed to fit into a system based on sound science minimizing risk. NGO expertise is called into question; it is not deemed as relevant in the system as currently defined. For instance in Germany, NGOs faced a ‘participation trap’: the NGOs were forced to either discuss agricultural biotechnology in terms of science and risk, or lose any expert status or privileges (Levidow 2007, 35). In Africa, the motivations for biotechnology and the way problems are framed are similar to that in Europe. There is clearly strong continental will to develop biotechnology in Africa. For example, the New Partnership for Africa’s Development (NEPAD) and the African Union (AU) created a High Level Panel on Modern Biotechnology in 2005 (NEPAD 2005). At the AU Summit and African Ministerial Council on Science and Technology (AMCOST) meeting in January of 2007, a 20-year biotechnology plan for Africa was adopted, along with the African Seed Biotech Program (Singh and Daar 2008). Most recently in the summer of 2008, there were two Africa-wide conferences on biotechnology. The ‘African Conference on Biotechnology’ was held in Libya in June and the ‘First All African Congress on Biotechnology’ was held in Kenya in September. These events resulted in two declarations on biotechnology: the Tripoli and Nairobi Declarations (ABNETA 2008; UNESCO 2008).10 The framing of biotechnology decisions that comes out of these various commissions, meetings and declarations is similar to that in the North. Biotechnology is generally put forward as an objective imperative. The narrative is slightly different. It combines neoliberal economic policy with moral development imperatives: biotechnology will contribute to increased productivity leading to economic growth and food security or poverty reduction. For example, authors of the Tripoli Declaration are ‘[c]onvinced of the vital role of Biotechnology as one of the major driving forces for socioeconomic development and contributing to the improvement in the quality of life and the attainment of the United Nations Millennium Development Goals’ (UNESCO 2008, 1). Similarly, the theme of the Nairobi Biotechnology Congress was ‘harnessing the potential of biotechnology for food security and socio-economic development in Africa’ (ABNETA 2008, 1). A report about biotechnology called ‘Freedom to Innovate’ produced by the AU High Level Panel also shows the motivations for biotechnology development in Africa. The document exhibits broader, yet similar thinking. The authors see biotechnology as a way: 10 The Tripoli conference was sponsored by United Nations Educational, Scientific and Cultural Organization. The main sponsors of the Nairobi conference were the African Union and the Agricultural Biotechnology Stakeholders Forum. The author attended the Nairobi conference.

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The Limits to Governance to improve agricultural productivity, public health, industrial development, economic competitiveness, and environmental sustainability (including biodiversity conservation) in Africa. It [the report] also shows that the measures needed to address biotechnology will strengthen Africa’s capacity to adapt other technologies to economic development. In fact, previous inabilities to build capacity in fields such as information technology hamper the continent’s efforts in biotechnology. (Juma and Serageldin 2007, 4)

Throughout these multiple reasons for developing biotechnology, a dominant objective motivation is neoliberal, seen in the focus here on ‘economic competitiveness’, ‘industrial development’ and ‘economic development’. The Northern notion of biotechnology as an objective imperative is thus echoed in the South, and this leads to a similar reduction in framing biotechnological problems. In Africa, as in the North, decisions about biotechnology are focused on minimizing risk via sound science (cf. Persley 1999). Risk assessment was the sole topic of a recent AMCOST meeting (AU 2007). The AU High Level Panel argues that ‘Africa’s regulatory institutions need transparent and high quality scientific capacity to assess biotechnologyrelated risks and to be able to regulate quickly, safely and effectively’ (Juma and Serageldin 2007, 11). In Africa, NGOs play a major role in putting forward the motivations for biotechnology and in framing debates about biotechnology. Unlike in Europe, the most prominent NGOs in Africa promote biotechnology. Chief among these NGOs is Africa Harvest Foundation International (AHarvest). In 2005, the Gates Foundation gave US$16.9 million to AHarvest to develop biofortified sorghum (AHarvest 2005). But even before this project was started, the CEO of this Kenya-based NGO, Dr Florence Wambugu, was a very outspoken proponent of the use of biotechnology in Africa. For Wambugu, Africa will never become food secure unless it embraces biotechnology, specifically GM. Wambugu spreads this message in high profile editorials, interviews, and as she travels to conferences in the North and South (Wambugu 1999; Wambugu 2000). Having shown how trends relating to collectivity and partnership in the North and South have bolstered NGOs in their involvement with biotechnology, and having shown how NGOs are involved in the framing of issues surrounding biotechnology, a Kenyan case study will now be used to show how these two aspects of governance interact. Governing Kenyan Biotechnology The discussion of AHarvest above begins to show how location and identity are important resources for NGOs engaging with biotechnology. No country illustrates this more clearly than Kenya. International NGOs based in


Kenya have been influential in national research and development efforts, in international initiatives and fora based in Kenya, in the development of Kenya’s regulatory system and biotechnology policies, and in specific regulatory decisions. Kenya is a hub for biotechnology research and development in subSaharan Africa. Kenya has been engaging with tissue culture and other nonGM biotechnologies since the 1960s. In 1998, Kenya became the first country (outside of South Africa) to conduct research on a GM crop: a virus resistant sweet potato project sponsored by Monsanto and the International Service for the Acquisition of Agri-biotech Applications (ISAAA), a Kenya-based11 international NGO (Gibbons 2000). Insect resistant cotton and maize, and virus resistant cassava are other GM crops also in various states of trials in Kenya. All these crops are being developed through donor-sponsored publicprivate partnerships, most with NGOs as key partners. Other newer projects have been announced, such as the water efficient maize partnership mentioned above, but are not yet in trial phases. Internationally, many initiatives, centres, and institutes are based in Kenya. In 2004, NEPAD launched its Biosciences East and Central Africa centre of excellence initiative based at the International Livestock Research Institute in Nairobi (ILRI 2003). In 2006, the Kenyan-based NGO AATF established the Open Forum on Agricultural Biotechnology, a monthly gathering of policymakers and scientists from across Africa to discuss agricultural biotechnology. And as stated above, the first All-African Congress on Biotechnology was held in Nairobi in September of 2008 and was sponsored by a Kenyan-based NGO, African Biotechnology Stakeholders Forum (ABSF). Similar to technology development partnerships, the biotechnology decision-making system12 has a long donor-supported history (see Harsh 2005) and NGOs have been involved in key ways. Donors that have supported regulation or policy-making related to biotechnology in Kenya include: the Dutch Government, the United Nations Environment Programme (UNEP) and the United States Agency for International Development (USAID) among others. Most recently in 2007, USAID funded a three-year biosafety project through the Program for Biosafety Systems (PBS) initiative (IFPRI 2007). Much of the focus of these donors has been on developing a regulatory system to enable GM research to be conducted in Kenya. At the heart of the 11 ISAAA’s global headquarters are in New York, but ISAAA Africentre, ISAAA’s headquarters for its efforts in Africa, is in Nairobi. ISAAA is used below as a shorthand for ISAAA Africentre. 12 The term decision-making system is used here in the broadest sense: the system of institutions and procedures that answer the following questions: What specific technologies should be developed? How will they be developed? How will the social, economic (including trade), legal (including intellectual property issues), ethical and environmental implications be considered?

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system is the National Biosafety Committee (NBC), whose job is to approve or deny applications for research or development involving GM. The NBC was created with assistance from the Dutch Government and UNEP. When the Dutch programme ceased, an international NGO was created based on the programme called Biotechnology Trust Africa (BTA). BTA remains an active NGO in Kenya. It is one of the two international NGOs that sit on the NBC, the other being ABSF. ABSF has been a critical actor in driving this process forward. It has organized many of the workshops related to biotechnology and biosafety and utilized its funding to keep the development of the biosafety system moving between donor initiatives. Overall, the biotechnology decision-making system is still being developed. It is a system in flux, and one with questionable legal authority (Jaffe 2006; Odame et al. 2003; Traynor and Macharia 2003). Given these facts, it is important to examine how the system works, and how NGOs are involved, in practice. This is accomplished in this case study by presenting the views and actions of key actors.13 In line with the argument of the chapter, the focus of the case study is on motivations for biotechnology in Kenya, how problems related to biotechnology are framed there, and how NGOs have been involved in contributing to problem framing and in collective decisionmaking activities. The general motivations for biotechnology and the way in which problems are framed in Kenya are consistent with that of Africa in general. Biotechnology is put forward as an objective imperative for economic growth and food security. A recent expression of this motivation can be seen in the National Biotechnology Policy, approved by the cabinet in 2006. The then Minister for Science and Technology said that the Biotechnology Policy ‘recognises the role that biotechnology can play in poverty reduction, enhancing food security and conservation of the environment and biodiversity’ (Ogodo 2006). The Minister also stated ‘that the government is determined to explore the use of biotechnology for the benefit of Kenyans, and to ensure that the country becomes a key participant in the international biotechnology enterprise within a decade’ (AFAA 2006). Biotechnology is linked to social benefits through global competitiveness. As mentioned above, Kenyan NGOs have been major players in putting this position forward for Kenya and for Africa more broadly. In addition to AHarvest, ABSF and ISAAA have been crucial organizations. All three are international NGOs, based in Kenya, and headed by Kenyan women. ABSF and ISAAA both contributed to the development of Kenya’s Biotechnology Policy. Speaking about this policy and reinforcing the notion of biotechnology 13 The data presented here are based on semi-structured interviews and ethnographic observation in Kenya from 2004 to 2008. Data quoted from primary material are cited as ‘interview’ or ‘field note’ and pseudonyms are used for anonymity.


as a necessity for Kenya, Wambugu of AHarvest stated ‘Without the policy, Kenya was going to miss out on the gene revolution’ (AHarvest 2006). When the narrative of biotechnology as an imperative is tempered, it is only done so in terms of discussions about scientific based risk assessment. If broader social issues surrounding biotechnology are mentioned at all, they are reduced to issues of minimizing risk. The actual state of institutional developments in Kenya is testimony to this. The vast majority of NGO and donor efforts have focused on the creation of a risk-based approval system centred around the NBC. Odame et al. acknowledge both the primacy of risk management in the NBC and its inability to conduct risk assessments: The issue of risk assessment and management of transgenic sweet potato and Bt maize in farms is another concern that the NBC has to grapple with. For the two technologies to generate the anticipated results while minimising potential risks, the capacity of farmers to conduct risk assessment and management at the local level has to be enhanced. (Odame et al. 2003, 23)

Again like the rest of Africa and the North, risk assessment should be done via a science-based approach. The phrase ‘Minimizing risks through sound science’ was often repeated at the Nairobi Congress on Biotechnology (field note 2008). Policy pronouncements and NGO statements are important for the framing of problems around biotechnology in Kenya. But how does this framing work in practice? One actor’s story is particularly important. This actor was a trained scientist working for the Kenya Agricultural Research Institute (KARI). She then received a fellowship from an international donor to pursue doctoral work in North America. After returning to Kenya, she spent more time as a scientist before moving to a main regulatory agency in 2003. In that year, several approvals were made by this agency which enabled testing of GM cotton, cassava and maize. She then began to work at an NGO. A central part of her story is the strategy that guided her work at the regulatory agency: policy-makers … [should receive advice that] is based on science, as they usually say [a] science-based approach. So I thought that KARI or any other person wishing to do research and showing that they have capacity to contain the GMO [genetically-modified organism], through risk assessment analysis should be allowed to test it. And then send this information to the National Biosafety Committee so that people can then decide. (Interview 2005)

The approach to decisions about biotechnology that guided the everyday actions of this actor – who was a key player in making regulatory approvals

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– was solely about minimizing risk through science: ‘I’m really for scientist being allowed to do their tests’ (interview 2005). The actor even acknowledges that there are other ways to frame issues about biotechnology: When I was working in KARI we would approach … regulatory agents to allow us to bring in materials for research and … they were not … looking at things the way we do. Even when we say we want to bring in materials just to work on and destroy [them]. They say, ‘no, [you] want to make Kenya a GMO country’. So that [laughs] would drag on and on. And now when I was the person in charge of making that decision I think that I was useful to the research community. (Interview 2005)

In the case of this one actor, she has participated in biotechnology networks in many different ways: as a scientist, an international student, a regulator, and as an NGO staff member. Her story shows how scientific problem framing circulates through biotechnology networks, along with scientific expertise (manifested in her training and experience as a scientist) and resources (manifested in the donor funding that supported her PhD and later work with the NGO). What does ‘participation’ look like given this science-based strategy towards biotechnology? NGO-facilitated workshops are the primary mechanism to provide participation. These workshops are generally sponsored by donors supporting the development of biotechnology or biosafety decision-making, such as UNEP, PBS etc. The workshops, however, are generally organized by a Kenyan-based international NGO, mainly ISAAA, ABSF or AHarvest. The Kenyan staff of these organizations are responsible for identifying ‘stakeholders’ whose views should be represented at workshops – a role NGOs as participatory and collective agents should be well suited to play. The organizing NGO is therefore responsible for inviting attendees. This task might be mundane, but it is not trivial. While many workshops are ostensibly open to anyone, if actors are not invited, it is unlikely that they would be aware of the workshop and thus unable to participate. Thus, the experiences of several kinds of actors regarding workshops are necessary to understand the realities of participation. The perspectives of key actors including donors, organizers, actors attending workshops, and actors not attending workshops are presented below, beginning with the latter. NGOs focused on environmental issues which tended to be critical of biotechnology experienced significant problems in attempting to access workshops. For example, several NGOs were not invited and were unaware of workshops sponsored by UNEP which addressed the development of Kenya’s Biosafety Bill and Biotechnology Policy. One of these NGOs, ‘Collective Environmental Farming’ was a network of approximately 30 communitybased organizations that focused on ecological land management. The organization had been active in Kenya for some time; it was founded in the


mid 1990s. The main offices of the organization were also located close to Nairobi. A representative of the organization was thus quite upset that she had not heard about the UNEP workshops until after the fact. Collective Environmental Farming was a part of a coalition of similar NGOs who all objected to the use of GM in Kenya. None of the five NGOs in the coalition had been invited to workshops on biotechnology or biosafety. An actor who coordinated this coalition commented on the situation. She went so far as to say that the interests of small-scale farmers were not represented at all in decisions about biotechnology because none of the NGOs in her alliance had participated in any workshops. Another NGO, an environmental law and policy organization, was also never invited to any meetings. This group was recently established and based in Nairobi. Funded by North American donors, the organization mainly trained Kenyan lawyers and officials about environmental laws. However, the Executive Director of the group had recently appeared on an international television news network where he discussed the potential environmental impact of GM crops in Kenya, and his view that Kenya did not have an adequate legal framework to conduct GM research. Commenting on the UNEP workshops, he said: ‘I didn’t know about any consultation at all. I had no knowledge’ (interview 2004). The actor particularly saw his organization as a potential productive contributor to the workshops that specifically dealt with legal and environmental issues: We’d be a natural fit. You see we have a working relationship with the Law Society of Kenya. So one would imagine, again with a broad definition of civil society, the Law Society of Kenya is a member of that civil society. (Interview 2004)

Here the actor draws on the idea of civil society participation in governance decisions as seen in policy trends in the North and South. As part of civil society, the NGO should be entitled to attend. However, this NGO, remained outside of the network of actors who actively participated. Access to workshops and participatory exercises can certainly be an issue in Kenya. However, the organizers of workshops generally believe that they have invited everyone whom they feel should be represented. Importantly, the organizers also invite organizations based on whom they consider to be constructive attendees. The views of another key actor illustrate this. This actor was a senior manager at one of the international NGOs responsible for organizing many of the workshops on biotechnology and biosafety. She held a PhD in the natural sciences and her organization was also actively involved in coordinating research and development activities. When she learned that some groups felt excluded from workshops, and that these groups felt that the views of small farmers were not represented, she stated her views on participatory exercises in general:

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The Limits to Governance Participation and stakeholder are words used to derail development, in my opinion. What is a stakeholder? One who is affected and effects the process? … Everyone is affected, everyone is a stakeholder in this sense. But stakeholders contribute positively in terms of insights. (Interview 2005)

In her view, whom one represents is not as important as ‘contributing positively’. This is another instance where a trained scientist entrenched in international research partnerships is in a position of power to choose who will have access to discussions. The environmental NGOs above were deemed not relevant; they were deemed as having no expertise to contribute. Actors that did attend workshops voiced concerns about how ineffectual they were. One such important actor was a legal scholar working at a Kenyan university. He was a particularly informed workshop attendee, as he previously worked with the NBC to draft key biosafety documents. His account shows how, on the surface, NGO-led workshops seemed cooperative and collective and were sometimes literally labelled ‘participation workshops’. However in reality, workshops were ‘jumbled’ at best: You should see the proceedings of the workshop that was called public participation … it lacked direction, in terms of what was the essence of the meeting … So you had all these [pro-biotech NGOs] … making adverts … of their work. It was really a shame. I mean, that it ought to have been called public participation. (Interview 2005)

Here is a ‘participatory’ exercise where there seemed to be a paucity of interests represented. It seems the goal is persuasion rather than listening to, or engaging with, citizens’ views. At the very least the legitimacy of such meetings can certainly be questioned. Access and legitimacy are tied to how problems are framed and solutions put forward. In Kenya, some NGOs clearly frame issues about biotechnology differently than just issues of minimizing risks through science. These NGOs want to discuss other social issues. A representative of one such organization provides an important viewpoint because her NGO, a consumer group, has actually been able to participate in workshops and in the NBC for several years. She discussed the way the NBC views its work. For the NBC, biosafety and biotechnology policy are: so much seen as scientific issue[s] and making a breakthrough on this was not easy … You know what our position is … other issues which are not science [should] also to be included in all the discussion, all the other legitimate factors, not only to look at the technology from a purely scientific level, but also to how people receive it. (Interview 2004)


Although this NGO was able to attend workshops and participate in discussions, it found itself in a similar participatory ‘trap’ to the German NGO mentioned above. This Kenyan NGO had difficulty trying to frame their issues in terms of science, so their concerns were largely left out of the discussion. Conversely, those who can access decisions tend to be scientists. A senior representative from UNEP, the main donor of many of the workshops in Kenya, stated that scientists are the main actors participating in biotechnology decision-making: ‘So a few scientists get together and prioritize what they want to; which techniques they want to tap. But ideally, there should be a broader sphere of priority setting activities’ (interview 2005). There is clearly a disparity in access to decisions. NGOs and actors participating in major donor networks who can voice their concerns scientifically are invited to workshops and steer agendas. Those actors outside of these networks, or unable to voice their concerns in a scientific manner, do not participate. At the level of the Biotechnology Policy, which is a statement of intent and not a scientific document, one might expect that there would be broader debates about what technologies should be developed, and about agricultural innovation trajectories in general. The same legal scholar mentioned above attended a workshop where the Kenyan Biotechnology Policy was meant to be discussed. Far from providing a platform for broad dialogue she stated that: ‘we were supposed to be discussing the Kenyan Policy but we were there having commercials and what biotech can do for Africa, which of course, then colours the debate’ (Interview 2005). The participatory exercise was meant to be a broad discussion and debate. But the debate was ‘coloured’; the framing of the debate was already set in terms of biotechnology. Herein lies the paradox with NGOs’ participation in biotechnology governance. Despite all the NGO-facilitated workshops, agricultural innovation trajectories in Kenya have not been opened up to democratic accountability or even to any more debate. If anything, frustration caused by some NGOs feeling ‘left out’ of decisions has fuelled further controversy over biotechnology in Kenya. Conclusion: Governance in Action The chapter has examined the limits of collectivity and of framing common problems in governance processes surrounding biotechnology. It argued that through NGO involvement, the way that problems about biotechnology are framed is linked to collectivity, cooperation and representation in decision-making. A scientific framing of problems circulates through major biotechnology networks and partnerships, along with connected scientific expertise and resources. This often creates serious issues concerning disparities in influence and access to decisions. Despite participatory activities, actors

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without access to resources or those unable to voice their concerns about biotechnology in scientific terms or parlance, remain outside of core networks and excluded from decisions. The argument has implications for the legitimacy of the larger system of donor-sponsored networks that are developing biotechnologies in Africa, within which NGOs are embedded. Issues surrounding legitimacy have been raised in previous critiques of governance in the North and of NGO participation in the South. Explicitly examining these critiques provides a means to draw out the implications of the argument and to ‘triangulate’ the findings. Previous critiques can generally be grouped into three related themes, all of which resonate with the Kenyan case study: access, legitimacy, and de-politicization. Firstly, perspectives from the North and South have shown how there will always be disparities in terms of accessing participatory activities or policy networks (for example, Atkinson and Coleman 1992; Cornwall and Pratt 2003). Tvedt (2006) specifically argues that there is a detrimental circulation of expertise within the international aid system, which limits broader involvement. For Tvedt, the powerful actors in this system are not just elites in society or community, but a new class of actors working in NGOs or in the international aid system bureaucracy. Many of the Kenyan NGO workers discussed in the case study, for instance the actor who was a scientist-turned-regulator and Dr Florence Wambugu would qualify as members of this new class of elite actors. Paradoxically, these actors see themselves as representatives of poor farmers and thus the opposite of elites. It was argued above that national identity is a resource for actors working for international NGOs; Kenyan NGO staff can represent the rural poor in national decisions because the NGO workers portray themselves as similar to the rural poor. Indeed, NGO actors shuffle many identities to create credibility, and thus access to decisions, in different contexts. For instance, when a journalist pushed Wambugu and asked her how a scientist from Nairobi would know the needs of the rural poor, Wambugu replied that she grew up on a farm and her mother was a farmer (Wambugu 2000). Secondly, governance has been critiqued in terms of legitimacy. Given that participation is becoming the mainstream in Europe and Africa, even in technological decisions (Kluver 2006 in Levidow 2007), some critics ask if broader involvement brought on by governance is undertaken for the sake of participation or persuasion? Are decision-makers engaging with and listening to citizens’ views or is the goal to manage or prevent conflict? (Hagendijk and Irwin 2006). For instance in the case study, the workshop to discuss the Kenyan Biotechnology Policy seemed aimed at persuading participants of the benefits of biotechnology for Africa, and not at discussing any of the complicated social, ethical, or legal issues tied to biotechnology. However, the case study also goes further and brings out larger, more systemic issues about legitimacy in the current paradigm of biotechnological interventions. Having NGO-facilitated participatory activities as part of public-private research partnerships – and even just including NGOs in these


partnerships – provides the partnerships with legitimacy. NGO involvement associates the projects, and perhaps even biotechnology more generally, with appropriate local ‘needs’. This is despite the fact that individual instances of participation might not provide any means for needs to be voiced or debated. Legitimacy is closely tied to the third and most important way governance has been criticized. Because of its focus on collectivity and cooperation, governance covers up politics inherent in decision-making (Pestre 2004). In other words, governance does not open up the politics involved in determining which problems become ‘common’ problems (Levidow 2007, 22). Even given all of the efforts of NGOs to facilitate participation in Kenya, none of them provides a means to question the scientific problem framing of biotechnology as an imperative for Africa. The narrative that biotechnology is essential for food security put forward by NGOs and policy-makers combines the moral imperative of ‘development’ with the neutrality of technological progression. It thus de-politicizes biotechnology, or makes it seem apolitical and above politics (cf. Ferguson 1994; Smith 2007). Given these critiques that show how power can be manifested in seemingly collective activities of governance, decision-making needs to be examined as it occurs in actual practice. There needs to be a focus on ‘governance in action’. For instance, the case study shows the benefit of examining how NGOs frame problems and how this process is tied to the larger networks of which NGOs are a part. This can elucidate the limits of non-governmental actors in terms of how cooperative they are or whose interests they represent. A governance in action approach can also help explore connections between debates about biotechnology in the North and South. Why is it that problem framing around biotechnology is the same in the North and South? The cynical view is that resources to develop decision-making capacity flow from the North to the South, and with it views about how biotechnology should be governed. One should exercise some caution in taking this position. Views about how technology should be governed are always open to reinterpretations, as some of the broader motivations for biotech in Africa show. No matter the extent to which Northern donors are exerting control over Southern debates about biotechnology, the mechanisms14 through which this influence works must be specifically examined and more fully understood.

14 Training and education are certainly key mechanisms. For instance in the case study above, a Kenyan actor received scientific training in the United States, which is a common occurrence and can act as a mechanism to spread a neoliberal approach to regulation (Essex 2008).

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ISAAA (2006), ‘International Service for the Acquisition of Agri-biotech Applications: Global Knowledge Center on Crop Biotechnology’, retrieved 30 October 2008, http://www.isaaa.org/kc/default.asp. Jaffe, G. (2006), ‘Comparative Analysis of the National Biosafety Regulatory Systems in East Africa’, Environment and Production Technology Discussion Paper 146. Jessop, B. (1998), ‘The Rise of Governance and the Risk of Failure’, International Social Science Journal 50:155, 29–45. Juma, C. and Serageldin, I. (2007), Freedom to Innovate: Biotechnology in Africa’s Development (Addis Ababa and Johannesburg: African Union and the New Partnership for Africa’s Development). KESSFF (2004), ‘The Thika Declaration on GMOs: Statement from the Kenya Small Scale Farmers Forum’, retrieved 31 August 2004, http://www. grain.org/research/contamination.cfm?id=161. Levidow, L. (2007), ‘European Public Participation as Risk Governance: Enhancing Democratic Accountability for Agbiotech Policy?’, East Asian Science, Technology and Society 1:1, 19–51. Lewis, D. (2005), ‘Individuals, Organizations and Public Action: Trajectories of the “Non-Governmental” in Development Studies’, in Kothari, U. (ed.) A Radical History of Development (London: Zed), 200–21. Mbaria, J. (2008), ‘Farmers Planting Maize That Poses Threat to Humans’, Daily Nation, retrieved 26 March 2008, http://www.nationmedia.com/ dailynation/nmgcontententry.asp?category_id=1&newsid=119641. Murphy, J. and Levidow, L. (2006), Governing the Transatlantic Conflict Over Agricultural Biotechnology: Contending Coalitions, Trade Liberalisation and Standard Setting (London: Routledge). NEPAD (2005), High Level Panel on Modern Biotechnology, retrieved 17 November 2008, http://www.NEPADst.org/biopanel/index.shtml. Odame, H., Kameri-Mbote, P. and Wafula, D. (2003), Globalisation and the International Governance of Modern Biotechnology Implications for Food Security in Kenya (Nairobi: African Centre for Technology Studies). Ogodo, O. (2006), ‘Kenya Approves a National Policy on Biotechnology’, retrieved 26 September 2007, http://www.scidev.net/News/index.cfm?fuse action=readnews&itemid=3174&language=1. Opoku-Mensah, P.Y. and Lewis, D. (2006), ‘Moving Forward Research Agendas on International NGOs: Theory, Agency and Context’, Journal of International Development 18:5, 665–75. Persley, G. (1999), ‘Agricultural Biotechnology and the Poor: Promethean Science’, in Persley, G. and Lantin, M. (eds) Agricultural Biotechnology and the Poor (Washington DC: CGIAR and US Academy of Sciences), 3–21. Pestre, D. (2004), ‘Thirty Years of Science Studies: Knowledge, Society and the Political’, History and Technology 20, 351–69.


Rayner, S. (2003), ‘Democracy in the Age of Assessment: Reflections on the Roles of Expertise and Democracy in Public-Sector Decision Making’, Science & Public Policy 30:3, 163–70. Robinson, M. (1993), ‘Governance, Democracy and Conditionality: NGOs and the New Policy Agenda’, in Clayton, A. (ed.) Governance, Democracy and Conditionality: What Role for NGOs? (Oxford: International NGO Training Research Centre). Schurman, R. (2004), ‘Fighting ‘Frankenfoods’: Industry Opportunity Structures and the Efficacy of the Anti-Biotech Movement in Western Europe’, Social Problems 51:2, 243–68. Singh, J.A. and Daar, A.S. (2008), ‘The 20-Year African Biotech Plan’, Nature Biotechnology 26:3, 272–4. Smith, J. (2007), ‘Culturing Development: Bananas, Petri Dishes and “Mad Science” in Kenya’, Journal of Eastern African Studies 1:2, 212–33. Traynor, P. and Macharia, H. (2003), ‘Analysis of the Biosafety System for Biotechnology in Kenya: Application of a Conceptual Framework’, International Service for National Agricultural Research Country Report 65, 1–46. Tvedt, T. (2006), ‘The International Aid System and the Non-Governmental Organisations: A New Research Agenda’, Journal of International Development 18, 677–90. UNESCO (2008), Tripoli Declaration. African Conference on Biotechnology: The Way Forward (Paris: United Nations Educational, Scientific and Cultural Organization). Wambugu, F. (1999), ‘Why Africa Needs Agricultural Biotech’, Nature 400, 15–16. Wambugu, F. (2000), ‘Feeding Africa’, New Scientist 166:2240, 40–43. Wellard, K. (1993), Non-Governmental Organizations and the State in Africa: Rethinking Roles in Sustainable Agricultural Development (London: Routledge).


Chapter 11

Deliberative Governance: Political Fad or a Vision of Empowerment? 1

Peter Bryant

Introduction So I believe that we need new ways of reaching out. New ways of listening to people. New ways of consulting on new ideas. New ways of engaging in a dialogue and deliberation. And thus new ways of building our democracy for the future. Citizens’ juries will help government shape the policies in ways that the people for whom they are created want. Direct citizen involvement in policymaking can be the ally rather than the enemy of a renewed representative democracy. (Gordon Brown 2007)

Concepts such as participation, citizen engagement, community involvement and deliberative processes have become buzz words for progressive policymaking. Strategy documents, policy papers and the speeches of politicians are littered with these phrases, often used interchangeably and frequently offered as little more than rhetoric. Those in positions of power, and so better positioned to influence policy, more often than not see such approaches as recipes for the more efficient delivery of policy and services and as a way of gaining kudos with the disillusioned voter. To others they offer little more than an opportunity to reinforce the interests of the powerful. These concepts, amongst others, are in many ways the mechanics of governance, and when debating what governance means, what it ought to be, and how it ought to occur we need to understand what we might call the micro-dynamics of these concepts in implementation. Most people would argue that more inclusive governance and broader participation is a good thing but the processes and activities of governance, how people are included, how their voices are heard, 1 Thanks must go firstly to all members of the l’ECID Steering Committee in Mali who cooperated fully with the field work investigation which this paper draws upon. Thanks are also due to James Smith, Abel Koné, Tom Wakeford, Michel Pimbert, Jasber Singh and Clairey Mason. The author visited Mali during 2006, he received travel grants from PEALS Research Centre, Newcastle University and the University of Edinburgh and financed the rest of his visit himself.

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how debate is engendered, shape on a practical and often local level what form governance will take and how effective it will be. Clearly when engagement is sought between people, communities of practice, interest groups and different scales engagement itself becomes increasingly political and risks becoming a technical hostage (or solution) of power and influence. Taylor (2001, 137) sees most participatory approaches as a ‘hegemonic device to secure compliance to and control by existing power structures’. Participatory processes give the sense and ‘warm emotional pull’ of participation but without its sharing of power. Taylor (2001, 125) argues that this actually serves to placate those in positions of power and ‘obscure the real levers of power inherent in the social relations of global capitalism’. In my own experience as a facilitator of participatory processes, clients initially appear attracted by the romanticism of the discourse only to backtrack upon the stark realization that such an approach means not only listening to the voices of citizens but also radically changing power structures so that their voices are loud and omnipresent. As Smith concludes (Chapter 7), most ‘governance’ is still in the form of advisory structures as opposed to embedded within decision-making bodies. If science and technology governance, especially in the life sciences, is to respond to the almost universal call for democratization, a different form of governance must be found. A useful starting point for an analysis of governance is Hagendijk et al.’s (2005) typology of science and technology governance styles. Summarized by Horst et al. (2007) in the context of European decisionmaking, its value is not as a watertight classification system but as a framework for analysis. It can be summarized as follows: • discretionary: policy-making takes place with virtually no interaction with members of the public; • corporatist: workable compromises between various stakeholders are central to this approach, which takes place in closed or highly regulated spaces. Who is allowed to enter these spaces and why is the key question; • educational: drawing on the deficit model of knowledge production, the assumption is that what is stopping citizens from making an informed decision as part of a policy-making process is a lack of knowledge. Once the public are educated they are capable of making the right decision; • market: science and technology is governed through the market place. People, as consumers, make decisions as purchasers; • agonistic: Decisions are made in the context of strongly oppositional positions, for example the management of nuclear waste in the UK; • deliberative: this approach sees citizens engaging in continuous debate, which ultimately draws conclusions for the public good.

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Although not particularly widespread in its adoption, the model of deliberative governance has received widespread interest from policy-makers and academics alike. It is aspects of this model of governance and in particular citizens’ juries that this chapter seeks to investigate in more detail. Firstly through an analysis of its usage in both the North and South and secondly through a more in-depth examination of what may be identified as a rare success story, the role of the Mali’s Farmers’ Jury in policy-making regarding the adoption (or non-adoption) of genetically modified (GM) crop varieties within Mali. Deliberating Citizens’ Juries The use of the citizens’ jury model, while not pretending to be the magic bullet (Wakeford 2004), has been an attempt to introduce the powerless into scientific debate and allow the articulation of marginalized knowledge systems. In the field of GM the UK alone has seen the Food Standards Agency’s (FSA) citizens’ jury on GM food (2003) (run by Opinion Leader Research), the government sponsored GM Nation? (2003) and the GM Jury organized by a team from the Policy, Ethics and Life Sciences Research Institute (PEALS) at Newcastle University. Similar GM juries have been held in Australia and New Zealand. More recently in the field of nanotechnology the Cambridge University- and Greenpeace UK-sponsored Nanojury took place in 2005 and in 2008 the Citizens’ Inquiry into the National DNA Database. Latterly in recognition of the global nature of much science and technology policy-making, attempts have also been made to bring together citizens for cross border deliberations such as the Meeting of Minds, European Citizens Deliberation on Brain Science (2005-2006). In the global South the most high profile citizens’ jury has been the controversial Prajateerpu which was held in Andhra Pradesh in India in 2001 (Pimbert and Wakeford 2003; Wakeford and Pimbert 2004; Kuruganti et al. 2008). Inspired by the workings of the Indian Jury, a Farmers’ Jury in Zimbabwe examined the future of smallholder agriculture in the country in 2003 (Coupe et al. 2005). Prajateerpu gave farmers who faced the prospect of a government driven plan for agriculture (Vision 2020), in which they had little or no involvement, a chance to shape their own vision. As a result of the process the UK Government’s Department for International Development (DFID) made official complaints to the two institutions where two of the facilitators worked and attempts were made to discredit the high profile deliberations. Drawing on experiences from the US (where citizens’ juries have been run since the 1970s), Germany’s equivalent (planning cells) and Britain (IPPR, the Kings Fund Policy Unit and PEALS at Newcastle University) (Smith and Wales 2000), a citizens’ jury usually consists of between 12 and 30 citizens who are brought together to deliberate on an issue of concern. The composition of

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the jury reflects the local population from which it is drawn, although some citizens’ juries which value empowerment over market research may include large numbers of participants who have been traditionally marginalized from decision-making processes. An oversight panel, consisting of key decisionmakers from a wide range of perspectives relevant to the issue aims to ensure rigour, to increase the chance of jury recommendations being implemented and to choose some of the knowledge holders who will present their opinions to members of the jury (PEALS 2003). Smith and Wales (2000) talk of the moralizing effect invited spaces such as citizens’ juries may create. In a deliberative setting an encouragement to offer opinions and respond to challenges can lead to the elimination of irrational ideas especially in the drive to produce solutions for the public good. It may lead to the production of ‘better judgements’ in that deliberation may allow the production of solutions, which would not be identifiable by individuals alone. It may also lead to mutual learning from both sets of experts (both those with roots in the dominant positivist knowledge production system and citizens drawing upon their lived expertise). In order for this to happen, a robust structure and lengthy process much different from the traditional focus group is used. Participants are encouraged to share and defend their ideas, in the words of Davies, Wetherell and Barnett (2006, 94): Such work includes exchanges between two or more speakers around a common topic with back and forth reactions to each other’s views; puzzling over an issue to work something out collectively; the sharing of reactions, for example to witness positions; trying to understand the position of other members of the Citizen’s Council; and willingness to be persuaded by another’s position. There is the possibility of disagreement, conflict and argument, and discussion of that disagreement. Ideally all this discussion should lead to a possibly, but not necessarily, consensual resolution or of conclusion to the question being explored.

The critique of participatory processes is well rehearsed and well documented elsewhere (Cooke and Kothari 2001). Wakeford and Singh (2008) see two main responses from government departments and those in positions of power to ensure that participatory processes (and in particular citizens’ juries) serve to reinforce existing knowledge validating systems and decisionmaking structures and so ensure business continues as usual. Firstly, after having been involved in the design of a process, if it feels uncomfortable with the outcome, to either ignore or suppress it. In the case of the Nanojury, the UK Government’s Department of Trade and Industry promised in September 2005 that it would provide a response to the Nanojury’s recommendations, at the time of writing this has still not been forthcoming. The second response to dealing with potential outcomes which may challenge the status quo has been process manipulation. It is worth examining


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the UK Government’s nuclear power consultation ‘Talking Energy’ (BERR 2008). Having already been heavily criticized in September 2006, after the High Court ruled that the government’s decision-making process had been unlawful as it had failed to engage in the fullest possible consultation, the Government launched a new consultation in May 2007 consisting of a consultation document, an interactive website and a series of consultation events (described as stakeholder meetings, site stakeholder meetings and citizen deliberative events). A subsequent complaint to the Marketing Research Standards Board (MRSB) ruled that the market research company Opinion Leader Research breached the MRSB Code of Conduct. At the time of writing the MRSB has concluded that ‘information was inaccurately or misleadingly presented, or was imbalanced, which gave rise to a material risk of respondents being led towards a particular answer’ (Greenpeace 2008). The framing of questions in order to elicit a desired response and firmly demarcate the boundaries of deliberation is a common strategy adopted by the commissioning bodies of deliberative processes. The Food Standards Agency citizens’ jury chose as its central question ‘Should GM food be available to buy in the UK?’ This clearly limited the extent of debate as it did not give permission for jurors to discuss broader contextual issues such as farming or food or poverty (PEALS 2003). However, participants in such deliberative processes frequently push for the boundaries of discussion to be permeable. In the Citizens’ Inquiry into the forensic use of DNA and the DNA database (Murtuja et al. 2008) boundaries were stretched as some conversations focused on issues such as the treatment by the police of people with learning disabilities and the inadequate sentencing of offenders. Such occurrences may be explained by participants’ recognition that the boundaries of such discussions are firmly and inflexibly drawn by policy-makers with undue regard to the complex inter-relationships which systems analysis would reveal. It may also be the case that many citizens so revel in the feeling of being involved in discussions that may actually influence policy that they start to voice real personal concerns which may or may not be linked to the issue under consideration. As Horst et al. (2007, 15) note ‘in specific exercises the framing of the debate frequently seems to suggest a separation of ethical, political, scientific and legal issues, but in actual deliberation these aspects are often highly intermingled’. For government, an understanding of how models of governance such as deliberative processes can fit with their own policy-making processes is very difficult to understand. Rule driven bureaucracies such as the European Commission derive their legitimacy from their relationship with the representative democracy of the European Parliament and a highly formalized consultation process. Their ability to identify the legitimacy of groupings coming together outside of this regulated process (such as representatives from the European Citizens’ Panel on the future of rural areas) is highly restrained. The argument that such a group gains its legitimacy from the process that it

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has followed is difficult to recognize by bodies (including membership based NGOs) who are so wedded to notions of representative democracy. The Indian Prajateerpu jury aimed to give farmers an opportunity to develop their own vision for agriculture in the state. In an effort to stimulate deliberation, jurors were given three different scenarios for agriculture which were shown as video recordings. A subsequent e-forum debate (summarized in Scoones and Thompson 2003) on the approach revolved around a number of key criticisms which will help us to further consider the role of citizens’ juries in science and technology governance more widely. Firstly, the Issue of Representation Sagasti (Scoones and Thompson 2003) suggested that the fact that the Prajateerpu jurors were selected through local community groups may mean that such groups could be associated with NGOs who would push for a techno-sceptic perspective rather than one that pushed for the ‘modernization of traditional agricultural practices’. John Gaventa commenting on the same e-forum however dismisses such claims, instead focusing on the importance of selecting participants who, because of their social positioning, would then be able to generate subsequent action based upon the deliberations of their fellow farmers. A similar debate is what Smith and Wales (2000) summarize as inclusivity versus representativeness. Should participants be selected solely as ‘representatives’ of local demographics or on the basis of their previous exclusion from such policy deliberations? Secondly, an Overemphasis on Expert Knowledge Such a privileging of expert knowledge according to Jules Pretty (Scoones and Thompson 2003), restricts forms of argumentation and the issues available for deliberation. This point is further developed by Richards (2007) who in his study of deliberative processes in African food security suggests that it is often not the content of the argument but the act of argument that actually shapes opinion. In such a situation the deliberative process is not an opportunity to share opinions and identify the best course of action for the public good but instead to demonstrate commitment to a certain group with standing in the community. Thirdly, a Drive towards Consensus Smith and Wales (2000) raise the concern that process facilitators in an effort to reach consensus, fuelled by time constraints, may close down space which allows participants to really understand and work through each other’s opinions. Commenting again on Prajateerpu, Sagasti (Scoones and Thompson 2003) voices concern over the possibility of group behaviour leading to a


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pseudo consensus. We may recall from earlier critiques of participation the work of Cooke (2001) who borrows from social psychology the Abilene Paradox to explain how group members may sometimes reach a less than optimal solution. Perhaps of more relevance is to question whether or not such processes allowed the reframing of issues by those that are usually excluded from policymaking deliberations and that this is witnessed by those in positions of power (Peter Reason commenting as part of the e-debate summarized by Scoones and Thompson 2003). It would appear on this score that Prajateerpu succeeded. In the words of a Syngenta representative who attended the jury: The way people asked questions was absolutely unexpected. I did not really know what were their feelings, what were their experiences, what kind of questions they were going to ask. Absolutely a new process of learning for me. Dr Partha Dasgupta. (Wakeford and Pimbert 2004, 29)

The jurors, after their deliberations, did not choose one vision presented to them over another, but instead reframed the issues and produced their own vision which was summarized in the Prajateerpu project report. The impact of the project is summarized by Wakeford and Pimbert (2004) as follows. Firstly, the DFID subsequently demanded the report be censored for a supposed misrepresentation of DFID’s Andhra Pradesh programmes. The Institute of Development Studies (IDS), one of the Prajateerpu project partners also placed a disclaimer on all electronic copies of the report. This action serves to demonstrate the fragility of such processes, which are forced to rely upon external funding. It is estimated that the Institute of Development Studies relied on between 60–70 per cent of its funding from DFID between 2000 and 2002 (Wakeford and Pimbert 2004). Secondly, Wakeford and Pimbert (2004) point to the widespread use of the Telegu language version of the report as an advocacy tool throughout the state, the establishment of a coalition of individuals and organizations to coordinate the attempts to influence policymakers and the facilitation of deliberation by small farmers back in their own communities based upon the Prajateerpu recommendations. Thirdly, coverage by four national newspapers, two national TV companies, and a number of local media outlets as well as international press coverage ensured that the issues were exposed outside of the immediate networks of the jurors themselves. Although the literature offering a critique of deliberative processes such as citizens’ juries is extensive, that which offers an insight into the policy impact of such experiments is sparse. Commenting on the same Prajateerpu e-forum, Anne Marie Goetz remarks: I wonder though, if there are any examples of policy makers actually changing policies as a result of these exercises. My impression is that there

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The Limits to Governance are few cases of policy makers changing their actions in response to citizens’ juries …. (Scoones and Thompson 2003)

It is this gap in research that the empirical component of this chapter aims to partially fill through interviews with decision-makers in Mali in the wake of l’ECID, the Malian Farmers’ Jury. L’ECID (Espace Citoyen d’Interpellation Démocratique, the Citizen’s Space for Democratic Deliberation) L’ECID took place in Sikasso in Mali in 2006. The process brought together 45 Malian farmers to deliberate the role of GM crops in the future of the country’s agriculture. L’ECID aimed to allow farmers: • to better understand what GMOs are and what are the risks and advantages they carry; • to confront viewpoints and cross-examine expert witnesses, both in favour and against GMOs and the industrialization of agriculture; • to formulate recommendations for policies on GMOs and the future of farming in Mali (ARdS 2006). L’ECID was organized by the Regional Assembly of Sikasso, with methodological support from the International Institute for Environment and Development (IIED) in London and the Réseau Interdisciplinaire Biosécurité (RIBios) of the Institut Universitaire d’Etudes du Développement in Geneva. Project funding was provided by the Swiss Development Cooperation (SDC) and the Netherlands Ministry of Foreign Affairs (DGIS). A Steering Committee was set up in June 2005 to develop and plan the citizens’ jury. This Steering Committee was made up of approximately 15 members from various NGOs, unions and government bodies in addition to the international NGOs who provided methodological support. ARdS (2006) and to a lesser extent Bryant (2008) offer a more in-depth record of the methodology employed by the process. The Oversight Panel agreed upon a list of 25 ‘experts’ from a variety of perspectives who were invited to present to l’ECID. Ten of them refused or were unable to take part. Participants gathered for four days to hear presentations from each of the ‘experts’ including farmers from France, South Africa and India, government researchers from Burkina Faso and Mali, scientists and various NGOs. After each session, participants were able to pose questions and discuss with each other what they had heard. After the final deliberative session, participants were able to ask any of the experts to return and answer certain questions posed by them. Eight of the experts were invited back. The participants worked in five groups (based upon the farmer


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classification used by the national cotton company the CMDT, i.e. large, small and medium producers as well as a women’s group) to produce a set of final recommendations. The farmers agreed unanimously to reject GM crops and instead proposed a package of recommendations to strengthen traditional agricultural practice and support local farmers. Such recommendations included a proposed agenda for research, approaches to farmer learning, a vision of organic farming, measures to tackle biodiversity and a suggested list of decision-makers who should receive the recommendations. The recommendations were passed on to the Sikasso Regional Assembly on 29 January 2006. Box 11:1 Executive Committee members of the ECID Steering Group Lyegoli Mamadou TEMBELE, Assemblée Régionale Mamadou TOGOLA, Institut d’Economie Rurale (IER) Souleymane OUATTARA, Centre Djoliba Issiaka DEMBELE, Jubilee 2000 CAD/Sikasso Oumarou SANOGO, Associations des Organisations Professionnelles Paysannes (AOPP) Youssouf SIDIBE, Compagnie Malienne de Développement des Textiles Daouda MARIKO, Union Rurale des Radios et Televisions (URTEL)/Radio Kene Boukary BARRY, Kene Conseils Barbara Bordogna PETRICCIONE, Reseau Interdisciplinaire Biosecurite (RIBios), Switzerland Michel PIMBERT, International Institute for the Environment and Development (IIED), UK

In a series of interviews conducted some five months after the event, key decision-makers, process facilitators and a number of farmer jurors identified a series of impacts, which they attributed to l’ECID. On 1 June 2006, Parliamentarian Boubacar Touré started a three-hour debate in Parliament, questioning the Minister of Agriculture on the use of GM crops in Mali. Most interviewees suggested that the debate was a direct result of l’ECID. Touré asked a series of 15 probing questions on, amongst other issues, GM crops, biodiversity, terminator technology, Malian research experiences, the dangers of cross contamination, field testing and future government strategies (ORTM 2006). Opinions seemed divided as to whether the Minister had performed well or had come away from the debate with his reputation tarnished: what was clear however, was that the debate raised the profile of the issue within the country. Furthermore, it appears that the approval of legislation which needs to be in place before GM crops can be introduced had been indefinitely delayed as a direct result of l’ECID. This suggestion came from both anti-GM campaigners and, most convincingly, from key pro-GM decision-makers. Commenting on

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his frustration over his continuous efforts to take legislation to the Council of Ministers which would allow the introduction of GM crops first through field testing, one civil servant revealed: ‘the delay has been because of the jury’; ‘It has been a great impact, this has caused a problem’. This opinion was verified by the coordinator of an International Biosafety project, ‘Everyone is pointing at this Citizens’ Jury in Sikasso’. ‘The impact (of l’ECID) has been very negative’. ‘Here (in Mali) things are stalling because of the misinformation made worse by the jury’. This is a significant achievement for l’ECID for, without such legislative approval, it is very difficult for GM crops to be introduced. In the words of a staff member of USAID Mali: ‘If no decree is signed it will be difficult for any donor to start activities’. Similarly Monrad Abdennadher, Monsanto’s West Africa Regulatory Manager commenting in an interview with the Independent newspaper on l’ECID: ‘We cannot go into a country unless there are clear biotech regulations, covering matters of biosafety and of how trials could be conducted and presented. Mali has none of these’ (Selva 2006). The impact upon politicians of the process is further evidenced by a request from the Sikasso Regional Assembly for a l’ECID follow-up workshop, with presentations from farmer jurors, for members of the Regional Assembly. This development must be considered in the context of the economic importance of the region (as the main agricultural producer) and also in the context of the power of the Regional Assembly after decentralization (Coulibaly and Hilhorst 2004; Djire 2004; Rawson 2000). In the words of a senior civil servant ‘Because Sikasso is so important the government is scared to go forward’. It was consistently the case during interviews that, when asked to identify the main organizations influencing the decision as to whether or not GM crops should be introduced into the country, respondents spoke of the corporations (especially Syngenta), USAID, the Government of Mali and government researchers (Institut d’Economie Rurale, IER). The jury appeared to produce concrete impacts, and responses, from the institutions highlighted as central to the importation of GM crops into Mali. A member of a USAID-funded Biosafety project revealed that: USAID and AgBio2 were to organise a workshop (in Mali), to counteract the Sikasso (l’ECID) but the atmosphere here is too hostile and so they say they will do it in Burkina Faso. I said this is defeatist, and then they have won in their ignorance.3 2 AgBio’s close corporate links are summarized by Paul and Steinbrecher (2003). 3 Likewise in a brief telephone conversation with an officer from USAID a frustration with a lack of progress was summed up as follows: ‘We want to run a Biotech conference with IER but this is not happening.’ It is not clear however whether or not this delay was as a direct result of l’ECID.


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So, it appears that this deliberative experiment has had an impact, albeit temporary, upon policy-makers. This may be the result of a combination of factors, summarized below, which may be of interest to the designers of future processes. In order to uncover some of these it is necessary to examine the political and historical context of the Malian deliberation which reveals a strong farmers’ movement operating in a partly decentralized system of governance, with a relatively free media, as part of a recent history of political mobilization and suggests that the opportunities for an open debate on the use of GM crops is more likely than in many other countries. A Conducive Political Context The Traoré regime, which came into power in Mali after a military coup d’état in 1968 was characterized by corruption and the brutal suppression of political opposition (Clark 2000). Citizen disaffection with the regime was expressed through strikes and demonstrations. Riots in several cities in early 1991 culminated in the killing of some 65 civilians by government forces. By March, Traoré had been overthrown. Following in the footsteps of many other African countries the new regime ushered in an era of democratic governance through the hosting of a National Conference. The public nature of the debates and the broad representation that took part (some 47 political parties participated) gave the meeting legitimacy amongst many Malians. The Conference set a timetable for the preparation of a new constitution and for multi party elections. There is no doubt that the new regime encouraged a greater level of political confidence amongst its population as witnessed by the increase in newly formed community groups who now felt sufficiently protected to be able to criticize government policy (Bingen 1998). In this environment producer organizations such as SYCOV (Syndicat des Producteurs de Coton de Vivriers) and CNOP (Coordination Nationale des Organisations Paysannes du Mali) were able to operate freely. The strength and self confidence of the farmers’ movement is evidenced through the number of occasions when they have flexed their collective muscle and taken strike action. This happened notably in 1991 over demands for cotton marketing and production policy change, in 1996 (Bingen 1998) and in 2000 when the majority of farmers refused to grow cotton in protest at the failure of the cotton company (CMDT: Compagnie Malienne de Développement des Textiles) to increase the price of cotton. The commitment of the government to democratic governance and the involvement of citizens in decision-making processes is further witnessed by two key features, decentralization (which gave opportunities for citizens to influence local policy-making, firstly, through the election of municipal officials, through obliging councils to debate issues such as municipal development programmes in public and secondly through granting every citizen the right to contest a council decision at an

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administrative tribunal (Couibaly and Hilhorst 2004) and also through l’EID (Espace d’interpellation democratique) the annual televised opportunity for citizens to put questions directly to cabinet ministers). Some interviewees talked of the importance of the decentralization process firstly in nurturing a culture of localized decision-making and secondly in strengthening the belief that decisions of significant importance to regional economic stability were not solely the preserve of the National Assembly. (We have the) protection of the law on our side, each region is free to decide their own course of action. Decentralisation gives the opportunity for people in the area to solve their own problems and the jury brings together people to make a decision. The jury reinforces decentralisation. (Kokozie Traore, President of the Regional Assembly)

Some interviewees also commented on the importance of the National Conference and l’ECID in cultivating a culture ready for debate and expectant of accountability. l’ECID is not a new thing, since 1991 every year there has been on December 10th an occasion when the government must respond at a national level. Some people say it’s just for show. This informed and influenced the Citizens’ Jury. (Boukary Barry, l’ECID facilitator)

Rather than parachute an external participatory technology, the steering committee sought to build on existing participatory practices and culture. A Citizens’ Jury Linked to Existing Social Movements Some practitioners see the strength of the citizens’ jury approach being its ability to work with hitherto unengaged members of the public. The converse argument is that in juror selection an approach which emphasizes participants’ social positioning and so their ability to generate subsequent action is more important than a random approach to selection (Scoones and Thompson 2003; Wakeford and Pimbert 2004). In l’ECID some farmer jurors were also local SYVAC representatives (Syndicat pour la Valorisation des Cultures Cotonniéres et Vivriéres, a national union of cotton and food producers). The recommendations produced from the l’ECID deliberations were fed back to other farmers through these representatives. One farmer interviewed explained: ‘The delegates told us what is OGM, the consequences as in the jury and the recommendations.’ The farmer went on to describe his concern that living in such close proximity to Burkina Faso he would be affected by cross contamination and his frustration that ‘I have no way to learn better. I have no documentation which will help me understand’. He suggested that one strategy would be to find funding for the farmer jurors to ‘go from village


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to village’ explaining the process and sharing the recommendations. This interview seems to go some way towards strengthening the argument that, if such an approach had not been adopted, it seems that l’ECID would not have had such a large awareness raising impact. Farmers’ organizations themselves also talked about the role of l’ECID in increasing awareness. Alimata Traoré of the AOPP commented: Our association helped choose the members and they then came back and gave us a report back. Their report helped us to understand the problem; we then went out to speak to others. (Alimata Traoré)

She further explained that the l’ECID information would be shared at the biannual AOPP assemblies. One of the jurors themselves who is also a Mayor explained how he had been disseminating the information: I have been reporting on this. The information has been spread out. I am secretary of the Village Association and member of SYCOV4 and I give information to the CMDT staff at village level and at SYCOV level. (Anonymous farmer juror)

Such linkages with social movements not only recognize the need to view policy-making through the lens of governance not government (as a centralized bureaucratic state) but may also serve to allow such approaches to build upon the traditions of local social movements rather than is the case with many socalled participatory approaches which obscure them in the search for the new participatory technological fix. Counterbalances Good practice in citizens’ jury design is the centrality of a project oversight panel made up of a range of stakeholders who are able to check for process rigour and most importantly to act as a counter force to the all powerful commissioning body. In Sikasso, a seven strong oversight panel including a well-respected ex-Minister (largely responsible for the implementation of the nation’s decentralization process), representatives from four international NGOs and the focal point for Biosecurity in Mali (ARdS 2006) met regularly. In the UK the government’s GM Nation? established a multistakeholder oversight group which included scientists, industry representative and an anti GM NGO; such a counterbalance was vital in strengthening the jury’s credibility. This is in direct contrast to other juries such as the UK’s Food 4 SYCOV (Syndicat des Producteurs de Coton de Vivriers) (The National Union of Cotton and Food Crop Producers). For an analysis of their role in Malian politics see Bingen (1998).

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Standards Agency GM jury who, on the advice of the market research company organizing the process, failed to put in place such safeguards. A Long-term Investment Citizens’ juries, if they are to move beyond the status of a glorified focus group, are resource hungry. Jurors must be supported, suitable ‘witnesses’ identified, agreed upon and briefed and crucially a clear advocacy strategy must be in place before work starts. In Sikasso work on the ground started a full year before the process began and jurors continue to be supported some six months later. A Media Strategy The increased awareness and national impact of the process was undoubtedly assisted by the high level of media interest. Seven local radio stations broadcast the deliberations live everyday. Three national newspapers covered the event as did the national TV channel.5 Many interviewees commented on the role of the media in allowing the debate to be extended from the l’ECID venue to the homes of thousands of Malians. Mamadou Goita of IRPAD (Institute for Research and the Promotion of Alternatives in Development and also the Coalition pour la Protection du Patrimoine Génétique du Mali) described how, since the jury, five Sikasso-based radio stations had been in touch with him to develop a better understanding of the issue in response to an increased interest on behalf of the listener. Goita saw this as an effect of l’ECID. People talked of the role of the jury in increasing awareness of the issue amongst farmers, but this increased awareness also extended to NGO, Union and Government representatives. The President of the regional branch of one farmers’ organization commented ‘We were not sure what OGM means but the jury helped us make up our mind’. This was reiterated by the President of Sikasso Regional Assembly ‘We are happy it (l’ECID) has started to help us understand the issue’. In developing a critique of citizens’ juries and other deliberative approaches it may be valuable to use cognitive justice as a framework of analysis, (Visvanathan 2005). In the words of Van der Velden (2005) who looks at knowledge production in computer based information systems: With cognitive justice there is no objective ‘expert’ position from which to design and develop technology. Cognitive justice focuses information systems 5 L’ECID also generated international media interest with newspaper coverage in the UK, France and Switzerland. To access some of the media coverage visit http://www.iied.org/natural-resources/key-issues/food-and-agriculture/deliberativedemocracy-citizens-juries#resources.


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design on the knowers and the environments in which their knowledge is situated. As a result the design process itself becomes a dialogue of diverse interests and values. (Van der Velden 2005, 107)

Visvanathan, however, may be disappointed as to how l’ECID and citizens’ juries fare when viewed through this framework. In the absence of a detailed knowledge of the methodology used during the actual process of l’ECID, it may be worth asking those more central to the organization of such processes in the future, the following questions. Through the structuring of the jury (i.e. a clear division between juror and expert witness) are those described as expert witnesses given a privileged status? Does such a privileging serve to further emphasize the value of one knowledge system over another (e.g. the undermining of the knowledge of the local Malian farmer)? Here we tread a very tricky line. On the one hand by blurring the distinction and allowing so-called experts to attend more of the deliberative discussions we risk the skewing of power dynamics so silencing the voices of the marginalized (Leach and Scoones 2005); on the other hand by excluding such actors from more of the deliberative sessions we risk losing the opportunity for such socalled experts to experience first hand the value of involving other bodies of knowledge (e.g. farmer knowledge) and of citizens recognizing their own knowledge on a more equal footing. However, the debate may be irrelevant when one considers the refusal of Syngenta, Monsanto and USAID to even present their own knowledge for 15 minutes leave alone enter a potentially more threatening deliberation over a few days on a more equal footing.6 The refusal of one key scientist to attend the Bamako l’ECID follow up workshop on the basis that it would purely give legitimacy to the process does not bode well. The model of cognitive justice also allows us to speculate where in the technology knowledge production process there is the space for other bodies of knowledge to be heard. Cognitive justice would not allow deliberation to take place only after technology has been designed, but, would also demand dialogue during the stage when research priorities are identified, the so called ‘front end’ questions (Leach et al. 2005). The government research institution IER (Institut d’Economie Rurale), was consistently identified by interviewees as an organization central to GM decision-making. However, the ability of such an organization to change its relationship with farmers and to formulate new notions of citizenship is unlikely for a number of reasons.7 Firstly, the legacy of French colonial science. Keeley and Scoones (2003) describe the role 6 This was also the case with key role players at Prajateerpu, as mentioned previously and also in the UK at the Blackburn with Darwen Citizens Jury (Wakeford et al. 2004). 7 This notion of a new relationship with farmers and so of citizenship is summed up in one of the l’ECID recommendations. ‘Centrally involve farmers in the entire research (R&D) process.’

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of expatriate scientists in applying scientific knowledge to increase yields and hence profits for colonial powers at the time of colonial rule. The resultant focus on improving varieties and dealing with pests has become a legacy they argue, which exists in Malian research stations even today.8 Another vital legacy is the inevitability that researchers will carry out research for whoever is able to pay for it. The reliance of research organizations upon external funding is well known (World Bank 2003; Paul and Steinbrecher 2003; Bingen 2006; Glover 2003) and clearly leaves one questioning the ability, and willingness, of researchers to be able to respond to the expressed needs of farmers themselves. One senior ex civil servant commented ‘Our governments (in West Africa) are not funding research. We (the research organizations) identify the problems, then the donor picks on the problem they think is relevant, which may not be the main priority’. Anecdotal evidence may confirm this, for example Shetty Raguran of USAID’s comment ‘Speak to IER (Institut d’Economie Rurale), I don’t think we will say anything different to them’. When sitting in the IER offices in Bamako it is hard to disagree when you are confronted with a desk bearing the label USAID Mali and a Syngenta calendar. Such reliance on external funding is also clearly a blow to the grand aims of Malian decentralization. Added to this are the effects of globalization and the development of international transboundary epistemic communities (Jansen and Roquas 2005) which may serve to further distance the scientist/researcher from the farmer. Such epistemic communities allow Malian scientists to collaborate with other scientists in richer nations and so gain further funding; one interviewee talked of collaboration with the University of California. Such unchallenged relationships will continue to perpetuate the dominant discourse of GM. Post jury the IER scientists interviewed as part of this study seemed as committed to the discourse of GM crops – the scientific or technical solution – as ever. When asked what national problems could be addressed through the introduction of GM crops, the response was typical of followers of the discourse, i.e. a technical solution which is capable of tackling the complex issue of hunger (Scoones 2003; Paul and Steinbrecher 2003; Keeley and Scoones 2003). Two senior research scientists both talked of a simplistic chain of events. The introduction of Bt Cotton leading to a reduction in the number of pests, a resultant increase in yields, leading to improved farmer income, so allowing the national issue of food security to be tackled. Such a narrative not only ignores the complexity of agro-ecological and agro-food systems but serves to exclude the value of non-technical, political interventions which may aim to address the problem in a more holistic manner. The peddlers of this discourse are the powerful multinationals hungry for new markets, USAID and other Western donors eager to ensure aid expenditure mirrors 8 Keeley and Scoones (2003a) also argue that an additional legacy is that of cousinage whereby certain ‘scientists with particular training and connections dominate’.


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their own interests and perceptions of how development ought to happen and also African scientists struggling with pitiful public budgets and pinning their hopes on their work aiding intractable problems. It is to their own benefits that the discourse frames the debate to the exclusion of other voices, and this is the context in which citizens’ juries must drive dialogue, improve representation and attempt to lever change. Conclusion It seems apparent that l’ECID represents much of the recent critique of deliberative governance and participation as peripheral or ‘window dressing’ by producing a high profile deliberative space which has succeeded in politicizing an issue of global importance and allowing marginalized voices to question the dominant discourse in favour of GM crops. The deliberative process has stimulated a three-hour debate in the National Assembly, delayed the passing of legislation crucial in allowing GM crops to be field tested in the country and stimulated requests from members of the Regional Assembly and media outlets to learn more about the issue. The jury has also succeeded in challenging the dominance of scientific knowledge through allowing the articulation of farmer knowledge and a broadening of the boundaries of the discourse. Central to the initiative’s success may have been its links to a strong farmers’ movement, a recent history of farmer struggle and decentralization, the use of counterbalances to ensure a credible process, and the interest of all major local and national media outlets. In Mali, through debate surrounding GM crops, we also see a technology which is not isolated from the main concerns of people’s lives and so is easily able to stimulate commitment and passionate debate through a broad cross section of the nation’s demographic. Of course the success of the initiative is highly context-dependent, just as the technology is not isolated from farmers and markets, the process of deliberation was not isolated from political and social histories, or from the institutions whose interests and agendas were played out in Mali. While l’ECID represents a success in deliberation it cannot by its nature represent more than the vaguest blueprint for engagement in other contexts. The powerful nature of the main role players involved, operating in the context of globalization means that, increasingly, such role players are looking for new ways to avoid the constraints of national legislation. Linked through transboundary epistemic communities, African scientists are able to form partnerships with research institutions in the North as well as biotech corporations themselves. Such corporations, with the backing of Western donors and international financial institutions, are increasingly pushing for the regional harmonization of GM regulations in an effort to quash opposition in country. In this context, while the citizens’ jury forced debate locally and even

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nationally, it would appear that the ability of such deliberative processes to engage internationally is more limited. This is particularly problematic in the case of deliberation over transnational issues, such as the introduction of GM crops into states with little or no prior experience. Governing the biosciences is as much about the borders of the state as the limits of the state and it is at this dual boundary, or limit, where more participatory forms of decisionmaking are most needed and are most often absent. The case of l’ECID in Mali, in highlighting the strengths of participation and deliberation at the local level, in building knowledge bases, empowering people and connecting people together, serves to underline the enormous gaps in deliberation and participation elsewhere. Smith (Chapter 7) highlights the sometime absence or weakness of the developing country state in decision- and policy-making regarding the biosciences and the fact that the initiative represents one of only a handful of participatory success stories in Africa speaks to the extent of this problem. Weak governments need strong civil societies and even stronger participatory processes in dealing with the complex realities and implications of dealing with the biosciences. L’ECID, in illustrating the positive role that can be played through citizens’ engagement and participation, calls for more and better quality engagement elsewhere and in other spheres. It is in the strength and extent of engagement such as in the case of Mali that governance processes become enmeshed with government structures to better engage with the promises and risks of the biosciences. References ARdS (Assemble Regionale de Sikasso) (2006), ‘Rapport général. Espace Citoyen d’Interpellation Démocratique (ECID) sur les Organismes Génétiquement Modifiés (OGM) en relation avec l’avenir de l’agriculture au Mali’, Ministére de l’administration territoriale et des collectivités locales (Mali: Assemblee Regionale de Sikasso). BERR (Department for Business Enterprise and Regulatory Reform) (2008), The Future of Nuclear Power: Analysis of Consultation Responses (London: HM Government). Bingen, J. (1998), ‘Cotton, Democracy and Development in Mali’, The Journal of Modern African Studies 36:2, 265–85. Bingen, J. (2006), ‘Politics, Agricultural Science and Technology in Sub Saharan Africa: The Challenges of Genetically-Engineered Crops’, unpublished paper presented at Culture, Nature, Future? Perspectives on Science and Development in Africa Conference, 12–13 April, Royal Zoological Society of Scotland, Centre for African Studies at Edinburgh University, ESRC Innogen Centre.


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Brown, G. (2007), Speech at National Council of Voluntary Organisations, (accessed 10 November 2008). Bryant, P. (2008), ‘Mali’s Farmers’ Jury: An Attempt to Democratize Policy Making on Biotechnology’, in Wakeford, T. and Singh, J. (2008), Towards Empowered Participation: Stories and Reflections, Participatory Learning and Action No. 58 (London: IIED). Clark, A.F. (2000), ‘From Military Dictatorship to Democracy: The Democratization Process in Mali’, in Bingen, J., Robinson, D. and Staatz, J.M. (eds) Democracy and Development in Mali (Michigan: Michigan State University Press). Cooke, B. (2001), ‘The Social Psychological Limits of Participation?’, in Cooke, B. and Kothari, U. (eds) Participation: The New Tyranny? (London: Zed Books). Cooke, B. and Kothari, U. (2001), Participation: The New Tyranny? (London: Zed Books). Coulibaly, A. and Hilhorst, T. (2004), ‘Implementing Decentralization in Mali: The Experiences of Two Rural Municipalities in Southern Mali’, Drylands Programme Issue Paper No. 127 (London: IIED). Coupe, S., Hellin J., Masekende A. and Rusike E. (2005), ‘A Farmer’s Jury: The Zimbabwean’s Poor’s Verdict on the Future of Agriculture’, Working Paper (Rugby: ITDG Publishing). Davies, C., Wetherell, M. and Barnett, E. (2006), Citizens at the Centre: Deliberative Participation in Health Care Decisions (Bristol: The Policy Press). Djire, M. (2004), ‘Mythes et réalités de la gouvernance locale: l’expérience de la commune rurale de Sanankoroba, Mali’, Drylands Programme Issue Paper No. 130 (London: IIED). Glover, D. (2003), ‘Corporate Dominance and Agricultural Biotechnology: Implications for Development’, Democratising Biotechnology: Genetically Modified Crops in Developing Countries Briefing Series Briefing 3 (Brighton: Institute of Development Studies). Greenpeace (2008), ‘Another Nuclear Consultation was Fixed’, (accessed 18 November 2008). Hagendijk, R.P., Healey, P., Horst, M. and Irwin, A. (2005), ‘Science, Technology and Governance in Europe’, final report on the STAGE project. Horst, M., Irwin, A., Healey, P. and Hagendijk, R. (2007), ‘European Scientific Governance in a Global Context: Resonances, Implications and Reflections’, IDS Bulletin, 38:5, 6-20. IIED (2006), ‘African Farmers Say Gm Crops are not the Way Forward’ IIED Press Release 29 January, IIED (online), available from accessed 12 August 2006.

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Jansen, K. and Roquas E. (2005), ‘Science Advice for Biotechnology Regulation in Developing Countries’, in Leach, M., Scoones, I. and Wynne, B. (eds) Science and Citizens: Globalization and the Challenge of Engagement (London: Zed Books). Keeley, J. and Scoones, I. (2003), ‘Seeds in a Globalised World: Agricultural Biotechnology in Zimbabwe’, IDS Working Paper 189. Kuruganti, K., Pimbert, M. and Wakeford, T. (2008), ‘The People’s Vision – UK and Indian Reflections on Prajateerpu’, in Singh, J. and Wakeford, T (2008), Towards Empowered Participation: Stories and Reflections. Participatory Learning and Action. No.58 (London: IIED). Leach, M. and Scoones, I. (2005), ‘Science and Citizenship in a Global Context’, in Leach, M., Scoones, I. and Wynne, B. (2005), Science and citizens: Globalization and the Challenge of Engagement (London and New York: Zed Books). Leach, M., Scoones, I. and Wynne, B. (2005), ‘Introduction: Science, Citizenship and globalization’, in Leach, M., Scoones, I. and Wynne, B. (2005), Science and Citizens: Globalization and the Challenge of Engagement (London and New York: Zed Books). Murtuja, B., Adria, K. and Ahmed, J. (2008), A Citizens’ Inquiry into the Forensic Use of DNA and the National DNA Database Citizens’ Report (UK: Vis-à-Vis Research Consultancy Ltd). ORTM (2006), TV programme (name unknown), ‘Séduee d’interpellation de Ministré de l’Agriculture l’Assemblee Nationale’ (Deputé Boubacar Traoré) sur les questions OGM (Questions orale) 1 June. Paul, H. and Steinbrecher, R. (2003), Hungry Corporations : How Transnational Biotech Companies Colonise the Food Chain (London and New York: Zed Books). PEALS (2003), The People’s Report on GM Crops (Newcastle: Newcastle University). Pimbert, M. and Wakeford, T. (2003), ‘Prajateerpu, Power and Knowledge: The Politics of Participatory Action Research in Development. Part 1: Context, Process and Safeguards’, Action Research 1:2, 185–207. Rawson, D. (2000), ‘Dimensions of Decentralization in Mali’, in Bingen, J., Robinson, D. and Staatz, J.M. (eds) Democracy and Development in Mali (Michigan: Michigan State University Press). Richards, P. (2007), ‘How Does Participation Work? Deliberation and Performance in African Food Security’, IDS Bulletin 38:5, 21–35. Scoones, I. and Thompson, J. (eds) (2003), Participatory Processes for Policy Change, PLA Notes 46 (London: IIED). Selva, M. (2006), ‘Mali Farmers Reject GM Crops as Attack on their Way of Life’, The Independent 31 January 2006, , accessed 20 November 2008.


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Smith, G. and Wales, C. (2000), ‘Citizen Juries and Deliberative Democracy’, Political Studies 48, 51–65. Taylor, H. (2001), ‘Insights into Participation from Critical Management and Labour Process Perspectives’, in Cooke, B. and Kothari, U. (eds) ‘The Case for Participation as Tyranny’, in Participation: The New Tyranny (London: Zed Books). Van der Velden, M. (2005), ‘Programming for Cognitive Justice. Towards an Ethical Framework for Democratic Code’, Interacting with Computers 17, 105–20. Visvanathan, S. (2005), ‘Knowledge, Justice and Democracy’, in Leach, M., Scoones, I. and Wynne, B. (eds) Science and Citizens: Globalization and the Challenge of Engagement (London and New York: Zed Books). Wakeford, T. and Pimbert, M. (2004), ‘Prajateerpu, Power and Knowledge. Part 2: The Politics of Participatory Action Research in Development’, Action Research 2:1, 25–46. Wakeford, T. and Singh, J. (2008), ‘Towards Empowered Participation: Stories and Reflections’, Participatory Learning and Action No. 58 (London: IIED). World Bank (2003), ‘The CGIAR at 31: A Meta-Evaluation of the Consultative Group on International Agricultural Research’, Vol. 2, Technical Report 9 May (Operations Evaluation Department World Bank).


Chapter 12

Governance in Action in the Life Sciences: Some Lessons for Policy Catherine Lyall, Theo Papaioannou and James Smith

Introduction This book set out to question conventional notions of governance in response to calls for more critical debate and guidance on its application in specific policy areas such as the life sciences. Our characterization of ‘governance’ has been broadly that of an increased role of non-government actors in policy-making through various participatory networks and mechanisms. In foregrounding governance as an inherently political process, concerned with articulating different actors’ interests, values and beliefs, we have also aimed at a more nuanced understanding of what ‘governance’ means and how it might be practised. This book has engaged with the core problem that the life sciences do still require a considerable degree of conventional command and control style regulation. Many of the complicating factors identified in the application of the governance agenda to science and innovation-related issues arise from complex interactions between this still-necessary, government-based regulation and the more participative forms of policy-making that are being fostered both to promote national competitiveness and encourage public acceptance of these new technologies. We have argued that there are actually limits to the all pervasive notion of ‘governance’ and that, instead, the multifaceted policy and regulatory situation that applies to genomics and the life sciences more generally requires the existence of some form of a government-governance continuum or synchrony. The preceding chapters have considered the application of some of the ‘new tools of governance’ to the life sciences from ethical, political, legal, social and policy perspectives and through a mix of theoretical, empirical and case study analyses. Despite the political (and academic) rhetoric about new governance approaches, our analysis highlights the enduring capacity of the state (in the North at least) to control and also to frame debates about new technology – hence ‘the limits to governance’. It would be expedient to suggest that, because we are dealing with the life sciences, concerns of biosafety and regulation necessarily keep the focus on government unlike other areas of policy. But this offers an overly simplistic

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interpretation of the issues. In fact, what this book demonstrates is a complex set of relationships between government and governance which influence all areas of science and innovation policy. This is the answer to Jordan et al. (2005) who ask whether governance has eclipsed government in the context of specific policy instruments and point to the need to move ‘beyond theorizing and conduct more detailed empirical testing’. In exploring how these new tools of governance might apply to the life sciences we have attempted to lift the debate from the realms of theory and rhetoric to examine real cases of governance in action. This argument travels and our examples have sought to broaden out from the Westminster model. The cases discussed in the preceding chapters have ranged across continents (Europe, Africa, Asia and America) and traversed multiple levels of governance including the national, international and supranational. Authors in this book have examined legal instruments, regulatory systems, international conventions and research initiatives. Our thinking has been guided by a tripartite organizing frame consisting of principles, processes and people. In discussing the principles of governance in the life sciences we have examined our conceptions of, and commentaries on, government and governance; how these are established; the role of justice and values, and the management of morality. We next examined some of the processes involved, both those that are well-established (such as the regulation of drug innovation in the US) and those that are in transition in southern African countries, as well as how processes translate across nations. Finally, we focused on people; which actors are involved in governance processes and what limits their involvement. The Limits to Governance Whilst it might be editorially convenient to think of government in terms of outputs (such as legal instruments) and governance as the process by which such outputs may be derived, we recognize that governance is indeed a slippery concept with multiple meanings and interpretations (Chapter 1). This presents difficulties around how and when it can be differentiated from traditional government perspectives. Coupled with this, there are well-articulated concerns that the move from government to governance presents problems of accountability and transparency: governance networks can, in practice, reduce open democratic debate (for example, Greenaway et al. 2007). While it is common for the literature on governance to explore whether the informal authority of networks has supplanted the formal authority of government, we have turned this discussion on the ‘limits to the state’ (Rhodes 2007) into a question about what limits governance. We have suggested that the policy and regulatory situation that applies to the life sciences presents a government/governance paradox. We have argued throughout the book for the

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existence of some form of government-governance continuum. This is not to resort to a simplified, linear dichotomy where the characterization of any one policy situation is either ‘government’ or ‘governance’ but rather a duality or co-existence of the two in some measure – the ability to exist in a sense as both at any one time depending on the particular policy situation. Indeed even one of the main protagonists of the ‘hollowing out of the state’ now concedes that ‘the traditional instruments of government co-mingle, compete and conflict with the new instruments of governance to variable effect’ (Rhodes 2007). We are therefore tapping into a well-rehearsed argument about the role of the state in governance and our argument is in line with other social and political scientists such as Peters and Pierre (2006, 213) who insist that ‘The state that remains in the face of numerous changes in governance is still a powerful actor. There may have been some hollowing out but when assessed more carefully we can … see that the “shell” that remains retains much of its real power’. What is novel is the focus that we have brought to bear on the life sciences in this debate where this apparent co-existence certainly does not always imply peaceful relationships. Rather it almost invariably leads to conflicts and tensions. Identifying these limitations can give us a clearer idea of the nature of the co-existence in order for life science technologies to develop and contribute to the public good in ways that are generally viewed as socially acceptable. Arguing from both theoretical and empirical positions, the preceding chapters have identified a number of limits to governance. We have seen that modern politics limit the fair distribution of opportunities and risks in genomics through a complex web of existing institutions and a dispersed range of heterarchical networks (Papaioannou). And we have explored cases (Milne and Tait, Laurie et al., Harmon, Nightingale and McLeish, Kanellopoulou) where in each situation, to differing degrees, a ‘hard’ government structure was still required in order to support the additional layer of ‘soft’, governance intervention. We have also identified geopolitical limits which mean that some of the northern interpretations of governance are much less applicable in developing country contexts (Smith, Mugwagwa); this may in turn place limits on the role of non-governmental actors (Harsh, Bryant). In highlighting the normative and empirical limitations of a governance approach to the life sciences, these examples of governance in action lead us to four lessons for policy which we now explore in more detail for the remainder of the chapter. Governance is Dynamic While the history of governance during the twentieth century may appear as ‘a shifting balance between government and governance’ (Rhodes 2007), this should not be interpreted as a steady, uniform, linear progression from

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government to governance. Rhodes admits that ‘the policy networks literature in general pays too little attention to change’ and this is a serious omission in a fast-moving policy field such as the life sciences where, as we have already noted, policy and regulation often struggle to keep pace with the science (Tait et al. 2006, 379). Although the state and its institutions remain central elements in governance, the latter is a dynamic process that responds to constant change. As Laurie et al. point out (Chapter 3), in the life sciences, change does not only concern biotechnological innovations but also values and interests. Thus, an effective governance regime in the life sciences implies the ability to anticipate and respond to both biotechnological and ethico-political changes. This ability depends on the mechanisms which are in place to engage with stakeholders throughout the life of the scientific endeavour and thereby to identify, map and respond to any shifting dynamics around their values and interests. Certainly, society has always had the task of steering its science and innovation activities. Before the term ‘governance’ was introduced and the model was well defined, steering was associated with the democratic state. However, even in that state-centric situation, the role of non-state actors was crucial. As Pierre and Peters (2000, 30) note, ‘We now have better ways of identifying and conceptualizing the role of non-state actors, but those actors were influential even before social scientists had the right words to capture their involvement in the process’. In the context of state-centric, democratic process, governance enhances or implicates certain values, and, as suggested by Harmon’s case study of the Human Fertilisation and Embryology Act (HFEA) (Chapter 4), it must be continually reconsidered to ensure that those values are appropriate and that it is meeting them effectively. A deliberative governance process should lead to a more detailed and rich understanding of the policy issues and possibilities, including – at least in the life sciences – moral issues. To this end, political institutions and structures should produce a common framework of enforced rules of democracy. As Stoker (2006, 154) points out ‘A democratic system does not require the participation of all the people or all of the time; rather, its defining characteristic is its openness to all’. Democratic governance situations are almost always dynamic, implying not necessarily continuity but also breaks in the chain where, for example, a change in government or another ‘event’ may cause a disjuncture. Nightingale and McLeish (Chapter 6) illustrate this point in the case of biosecurity where global political events have caused a backing away from governance measures and the reinvigoration of government controls. Likewise in the case of drug regulation, the Vioxx incident described in Chapter 1 resulted in tighter controls to prevent conflict of interest and ensure greater transparency, contrary to the generally de-regulatory climate. Staying with drug regulation, Milne and Tait (Chapter 5) highlight a complex, dynamic interdependence between government controls and governance processes. Ultimately governance in all its forms and through all its levers, is dynamic because it represents, firstly, an articulation between state


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and society and, secondly, because it represents a means to articulate values, beliefs and politics. Governance, as both a process and a vision of how state and society ought to interrelate, profoundly reflects the dynamism of change in all its facets, political, economic, societal, and this dynamism is thrown into yet sharper relief by the challenges laid before us by the life sciences. Capturing this dynamism is precisely what governance – as an effective policy process – should be doing. But, what many of the chapters have demonstrated, is that this remains both problematic and increasingly necessary. Governance is Context Dependent Recognizing that new technologies in themselves shape (and are shaped by) the ethico-political context in which they are developed, exist and impact upon society, Smith (Chapter 7) examines the shifting context of science policy in development countries and reflects on what ‘governance’ actually means in the context of new bio-scientific technologies, weakening states and multiple, complex external dynamics. Many of the constructs and terms we rely on to describe and explain the governance of the biosciences in more developed countries are therefore much less precisely understood in the context of developing countries. Governance has its own genealogy in Africa and in Europe. Yet the critiques surrounding governance, participation and NGOs in the North and South are similar. The chapters by Mugwagwa, Harsh and Bryant explore the nature and limits of governance in these contexts where coordination and harmonization of governance remain firmly centred on the state. As we have seen, using the example of biosafety policy processes in southern Africa, Mugwagwa (Chapter 8) brings to the fore some of the realities that technology governance faces in a developing country setting, making a case for multi-pronged approaches, including a return to government, even in an era where governments are generally agreed to be playing a receding role. Harsh (Chapter10), on the other hand, addresses another paradox. While discussions of new modes of governance create expectations and obfuscate the politics inherent in choices about biotechnology, he argues that, despite greater involvement of NGOs in the governance of biotechnology, decisions about developing biotechnologies are generally not more democratic or accountable. The addition of NGOs as another type of development actor has often made projects less democratic. Whereas the state’s power in Europe may be eroding in a shift to governance, states in Africa have never had as much direct control of decisions. Harsh concludes that there is almost surely more room for the state and for government in the realm of biotechnology in Africa. Harsh’s conclusion provides an empirically grounded backing to one of the most critical arguments against governance; namely that discussions of governance create a misleadingly consensual picture of decision-making, even though there can be significant issues surrounding access, legitimacy

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and accountability. The problem, as Pierre and Peters (2000, 67) put it, is that governance often invites politically illegitimate and non-accountable actors into the processes of steering. Even if the intention is to maintain lines of legitimacy and accountability, the complexity of the merging relationships between the state and non-state actors may make it difficult for citizens to understand how legitimacy and accountability function (ibid). In some developing countries, of course, state actors are virtually absent. Therefore, governance gradually takes the place of weak or non-existent government and regulatory frameworks. In some other developing countries, government and the state facilitate decision-making through governance. The case of Mali (Bryant, Chapter 11) demonstrates an example of decisionmaking in action and allows us to ask questions about who should be involved in decision-making of this sort, and how real dialogue between scientists and citizens can be promoted in order to build better agricultural technologies for Africa’s producers and consumers. In arguing that governance is context-dependent we also acknowledge that, in practice, it can effectively be organized to operate independently or parallel to context, purposefully or not. Several of the chapters that focused on the governance of life sciences in developing countries highlighted the absence, retreat or weakness of the state. This can create spaces in which ‘governance’ processes may occur in parallel or apart from the state. Issues of scale and scope, both geographical and political, serve to embed or remove governance from its context. Several chapters highlight that the more ‘successful’ governance processes took place where context was more fully understood and engaged with. There is thus a need to understand how better to use governance to broaden decision-making with and within weaker states in order to bolster their poorer array of options, resources and policy instruments. There is a corresponding need to understand the politics and power of the governance process itself; it may be shaped by contexts but it also shapes contexts. Governance is Political The choice of policy tools reflects political and cultural norms (Chapter 1) and it is generally the case that the political sensitivity of the life sciences requires strong, direct governmental control rather than self-regulation. Although networks seem to play an important role in the steering of life sciences innovation, and wider stakeholder and public engagement inevitably leads to demands to bring a range of broader interests and values into consideration in these decisions, this process does not take away the need for political judgements about the direction to be taken. Such policy decisions are ostensibly science-based but have always been influenced by interests and values. The concept of governance has historically emerged from within the very concept of government. Therefore, by definition, governance is political.


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Specifically, when it comes to aggregate political issues such as social justice, political judgements are presupposed of policy-making. Governance models need to address the normative and empirical limits of self-organization and chaotic networking, opening the way for a plausible institutional response based on politically developed principles of distributive justice (Papaioannou, Chapter 2). Harsh (Chapter 10) and Bryant (Chapter 11) argue that governance may both embody politics (as in the case of the highly politicized and politicallyfunded NGOs Harsh encountered in Kenya) and provide a means to resist powerful international political forces and engage with them locally – as the case of Mali illustrates. These cases represent different slices of politics and its relationship to decision-making and stand in opposition to the notion of processes and intermediaries as somehow apolitical and interested only in development which is very apparent in discourses regarding the role of science, and the life sciences, in economic, social and political development. As Laurie et al. have argued (Chapter 3), one way to improve governance models and the experience of those stakeholders involved and affected is through the incorporation of mechanisms that make explicit the valuepositions that inform and are supported by decisions or policies, and the articulation of reasons for these decisions or policies as they impact on the governance of the life sciences. However, another way to improve governance in specific areas of the life sciences is to bring back government command and control. Indeed, Nightingale and McLeish (Chapter 6) demonstrate a return to government: a re-emergence of state-centric security measures. In the politically sensitive area of biosecurity policy, rather than a reduction in traditional hard security and an incorporation of ‘new security challenges’, we have seen an expansion of hard security as nation states expand the scope of coercive control and implement new security legislation. The changes in biosecurity policy and its increasing interaction with science policy outlined in Chapter 6 highlight the limits of ‘governance’ as a theoretical concept. It is certainly true that recent changes in biosecurity policy can be easily fitted into a governance framework, but Nightingale and McLeish’s more detailed analysis highlights both major anomalies and more convincing explanations. While the implementation of new biosecurity measures has involved a degree of self-regulation this does not amount to a shift away from the state to public participation in governance. We stated at the start of this chapter that we were aiming to achieve a more nuanced understanding of what ‘governance’ means and how it might be practised. Central to this is an acknowledgement that there is no ‘most appropriate’ mix of governance or ‘blend’ of policy tools as we discussed in Chapter 1. Instead, there is a constant ebb and flow and a shifting frontier between government and governance and a constant reconfiguration of the roles and limits of modalities of governance. Governance, through its complexity and binding to context, reflects politics broadly-writ and in doing

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so reflects multiple contexts and perspectives, dynamism and change, in terms of what it articulates and how it ought to be practised. What is clear is that governance engages politically at multiple levels and in multiple ways. Governance Cannot Stand Alone Whatever way society chooses to steer the new life sciences, one thing is evident: governance cannot stand alone. Whether practised as an intimate engagement with the state, that may indeed call for a stronger state (Milne and Tait, Chapter 5) or performed as a series of parallel, external activities more closely linked to markets, innovation or R&D (Smith, Chapter 7), successful governance processes require engagement with government and the political state. Where this engagement takes place reflects the decision-making process, what decision is to be made, and who has the power and authority to make that decision. Informal governance processes do not always need to recognize national boundaries and can connect together new interest groups and interested parties in new ways. In part this reflects the particular nature of the life sciences and the benefits, risks and values it encompasses, in part it represents an increasingly globalized means of engaging with policy but ultimately it reflects the propelling need to engage with government. Milne and Tait (Chapter 5) illustrate very clearly the necessity to foster innovation, but also to control risk when governing the life sciences. While the scientific complexity and public unease with new healthcare technologies typically proscribe industry self-regulation, overly burdensome regulatory regimes can thwart the speed of innovation and limit the number, dynamism and diversity of innovators necessary for a high-tech field to sustain itself. The premise of their chapter is that the US Food and Drug Administration (FDA) has two programmes, the orphan product and fast track programmes for the development of new medicines, which serve as useful models of a regulatory system evolving towards a governance approach. These programmes evince certain characteristics associated with governance such as push-pull incentives and a problem-solving philosophy, but also demonstrate features of old-style command-and-control government, but with more control and less command. The authors suggest that these kinds of programmes have applications across a spectrum of different economies and technologies by combining industry incentives, increased government intervention, and stakeholder inclusiveness in an efficient approach that is not contrary to a governance agenda. Despite the tensions between the promotional role of a regulatory agency under governance and its public health oversight role under government, this evolved approach is only limited by the willingness of government to cede control in proportion to the willingness of industry to cede corporate self-interest and of public stakeholders to agree on public health priorities. The paradox in this chapter is that, although more rather than less intervention from the top down is brought to bear, it is of a complicit rather


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than compelling nature, facilitating problem solving between policy targets and policy makers. Hence there is ‘more control, but less command’. Milne and Tait argue that the orphan and fast track are exemplars of government programmes that function as governance tools at the regulatory system level. Combining industry incentives, increased government intervention, and stakeholder inclusiveness can be an efficient approach for promoting science and innovation that is not contrary to a governance agenda of encouraging both private sector investment and public engagement in a common goal. Thus we see a pragmatic example of a positive combination of government and governance approaches although the authors acknowledge that there is a limit to the utility of this model, that limit in essence is framed by the bargain that how much control the government can give up is in direct proportion to how much self-interest the governed are willing to give up. Several authors demonstrate why the challenges of this ‘new governance’ of science and innovation lie less in the philosophy of the approach but more in its execution. Laurie et al. (Chapter 3) add a further layer of analysis in their chapter which is the particular role played by interests and values within the rubric of new governance regimes. They describe how the UK Biobank has combined ‘hard’ government in terms of protecting the interests of participants as well as ‘soft’ governance taking into account different values and interests and ensuring continuing participation by members of the public in the biobank and its governance processes. Describing this as the ‘Ethics+ approach’, where the governance regime has been developed over and above existing regulation, they illustrate the way in which government and governance are not functioning as two poles of a continuum nor as two completely intertwined entities, but as a ‘soft’ wrapping of governance around a ‘hard’ core of government. These authors conclude that, while it is ‘inconceivable’ that government alone would provide a sufficient basis for the establishment of the biobank, equally the legislative framework was required to provide a layer of protection to participants without which trust in the biobank would be unlikely to be gained. Other authors suggest a combination of deliberative governance and political (joined-up) government as a good solution to the problem of effective (both fair and problem-solving) steering of new life sciences innovation (Papaioannou, Chapter 2). This solution presupposes the democratic involvement of the life sciences. Government and the political state can provide the framework within which deliberation can be realized. To some extent, this has already been happening. For example, the involvement of patient advocacy groups in funding, facilitation and management decisions on biomedical and genomic research is on the increase. This increase is coupled with the creation of innovative modes of governance, such as group management of collective resources (such as tissue banks and databases), contractual agreements, influence on research direction, and intellectual property solutions. But these developments still leave open questions for law and regulation to develop

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interactive but also hierarchical and control-style governance approaches in genomics (Kanellopoulou, Chapter 9). Kanellopoulou highlights the necessity to develop new models of group protections that both meet the needs and values of non-governmental stakeholders such as patient advocates, but also reconcile these with the state’s ability to exert some degree of control over their activities. In the absence of other protections, patient advocates increasingly seek to negotiate contracts in gene-discovery and drug-related research through private written agreements. Such contractual negotiations can help to avoid disputes but Kanellopoulou warns of significant concerns when groups rely on private means to negotiate and exert substantial control over the terms of research: these ‘self-help’ models may work in some instances but it is uncertain whether they would be enforced by the courts. This untested form of governance, lacking as it does an underlying legal (government) framework, appears to be the opposite of Laurie et al.’s model. Here we have the ‘soft’ wrapping of governance without the underpinning of ‘hard’ government and Kanellopoulou points to significant caveats about the viability of this stand-alone model. In a similar vein, the HFEA 1990 (and 2001 Regulations) are command and control instruments, that nevertheless require a dynamic and ongoing balancing exercise which is forever being recast or reinvented as new technologies and processes come before the HFEA that were not envisioned when the regime was drafted. Harmon (Chapter 4) thus assesses that the HFEA’s processes are an example of governance in action. Harmon concludes that, although the HFEA 1990 constitutes a deliberative democratic exercise closer to the governance pole where both its formulative and its subsequent operative processes reflect many of the elements of a governance model, its output (a legal instrument) ultimately supports the government model. Mugwagwa (Chapter 8) also discusses the challenges brought to the theory and practice of governance by this multidimensional interface between a new technology, limited regulatory preparedness among countries and the (apparently inevitable) plethora of new institutions and processes to manage it. Mugwagwa’s case study shows that the new international institutions developed to deal with new biotechnologies in the context of uneven regulation in southern Africa result in more engagement with governments and not less. Supra-national regulatory bodies do not replace national decision-making processes but instead provide new avenues for engagement and negotiation. Governance, ostensibly meant to harmonize regulatory processes and policy, provides new opportunities for debate, around how harmonization and institutions should be built, and exposes new contexts and perspectives and ways to engage with states in southern Africa. In underlining that governance is content-bound and political it is almost inevitable to also conclude that governance can only exist in relation to the state. The degree of reliance on the state, with government, hard law and regulation, may differ through context, application and through time but it is


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always there. This plurality, which may be highly diverse, often contested and sometimes not visible or intuitive, forms the core of our analysis and of the focus of this book. The relationship between governments and governance may be fuzzy, oppositional, reinforcing or superficial, but it is always present and it is by understanding this relationship and its problematics that we seek to draw conclusions and lessons for policy from across our broad spectrum of perspectives and empirical studies. Conclusion According to Rhodes (2007) ‘a decentred approach treats policy advice as stories that enable listeners to see governance afresh’; so what then can we learn from the stories our authors have told? As outlined at the start of this chapter, we have sought to problematize conventional notions of governance and participatory policy networks and have endeavoured to reconcile them with the often contradictory but still necessary government controls that attempt to both ensure public safety and promote national competitiveness through the life science industries. All of the authors in this book have tried to come to terms with different forms of this government-governance duality in the realm of policy-making for the life sciences. This co-existence is rarely symbiotic or entirely equal. Rather, it is weighted in different ways depending on the context, political system, historical trajectory and so forth. For example, in the context of developed countries and under circumstances of biosafety, we have seen the balance shift back to government control. By contrast, in the context of developing countries and under circumstances of the absence of the state, the balance shifts to governance networks and non-governmental actors. We have seen positive, synergistic combinations of the two approaches with examples of increased government regulation leading to better governance of innovation (Milne and Tait, Chapter 5); governance processes leading to legislative outputs (Harmon, Chapter 4); and a government framework providing the protection necessary to support a governance approach (Laurie et al., Chapter 3). But we have also witnessed the enduring influence of power and politics, regardless of context. Placing government and governance at the opposite ends of a hypothetical continuum has forced us to consider how they exist as a duality. We have found that government and governance rarely reside at opposite poles of this continuum. Instead their relationship is dynamic and evolutionary. There is a shifting frontier between government and governance that has to be decided upon on a case-by-case basis depending on the policy context. The cases offered as exemplars in this book demonstrate that this boundary is contested and fought over. This is not to conclude that there are no normative principles

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of governance of science and innovation. Rather such principles are ethicopolitical and presuppose the state in order to be implemented. Certainly, the more deliberative and accountable the governance of science and innovation is, the more value is added to existing regulations. The latter are legitimate frameworks of action only if they are based on values and interests democratically debated through governance mechanisms. The preceding chapters also demonstrate that such governance mechanisms have been used, albeit with mixed success, to fill gaps in regulatory provision. Chapter 1 set out some of the complicating factors involved in the application of the governance agenda to the life sciences, pin-pointing the challenge of how best to incorporate the most useful aspects of governancebased approaches and reconcile them with the still necessary systems of regulation. Much has been written about public participation as a new tool of governance for the life sciences and there is broad agreement that we need new rules of engagement in the governance process for the diverse stakeholder groups involved (Chataway et al. 2006). How this engagement takes place again reflects the complexity of context and reminds us how rarely such processes may be applied elsewhere with any degree of success. Policy-makers clearly believe that governance, in the form of improved participation in the policy-making process, will create more confidence in the resulting policies and ensure more effective implementation. But, as we have noted above, a focus on governance can both create a misleadingly consensual picture of decision-making and often invite politically illegitimate and nonaccountable actors into the processes of policy-making. By examining some of the principles and processes of governance and focusing on some of the people and groups engaged in them, the preceding chapters go some way to debunking this twenty-first century myth that the challenges of policy-making for the new life sciences can be tackled simply by greater consultation. This approach overlooks the unresolved tensions in the expectations that, through participatory governance, policy-makers will simultaneously engage with a wider range of stakeholders; increasingly base their decisions on evidence; and be able to reconcile conflicting views of that evidence in order to deliver both greater transparency of new technologies to the wider publics and greater accountability of the main commercial producers and users of those technologies. The prevailing tendency to accentuate public participation in the policymaking process ignores the underlying complexities – and limits – of governance. By acknowledging some of the limitations of current governance structures that we and our co-authors have identified, a more creative set of alternatives may emerge.


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References Chataway, J., Tait, J. and Wield, D. (2006), ‘The Governance of Agro- and Pharmaceutical Biotechnology Innovation: Public Policy and Industrial Strategy’, Technology Analysis and Strategic Management, 18:2, 169–85. Greenaway, J., Salter, B. and Hart, S. (2007), ‘How Policy Networks Can Damage Democratic Health: A Case Study in the Government of Governance’, Public Administration, 85:3, 717–38. Jordan, A., Wurzel, R.K. W., and Zito, A. (2005), ‘The Rise of “New” Policy Instruments in Comparative Perspective: Has Governance Eclipsed Government?’, Political Studies, 53, 477–96. Peters, B.G. and Pierre, J. (2006), ‘Governance, Government and the State’, in Hay, C., Lister, M. and Marsh, D. (eds) The State: Theories and Issues. (Basingstoke: Palgrave Macmillan). Pierre, J. and Peters, B.G. (2000), Governance, Politics and the State (Basingstoke: Macmillan). Rhodes, R.A.W. (2007), ‘Understanding Governance: Ten Years On’, Organization Studies 28:08, 1234–64. Stoker, G. (2006), Why Politics Matters: Making Democracy Work. (Basingstoke and New York: Palgrave, Macmillan). Tait, J., Chataway, J., Lyall, C. and Wield, D. (2006), ‘Governance, Policy and Industry Strategies: Pharmaceuticals and Agro-biotechnology’, in Mazzucato, M. and Dosi, G. (eds.) Innovation, Growth and Market Structure in High-tech Industries: The Case of Biotech-Pharmaceuticals. (Cambridge: Cambridge University Press).


Index A-T Children’s Project 194 ABCC6 gene 202 Abdennadher, Monrad 248 Abilene Paradox 245 abortion 86, 96 Abrahamsen, Rita 140 accelerated authorization procedures 125–6 advocacy groups 97, 107 patients see patient advocacy groups Africa see also under names of individual countries biosafety 13, 171–90, 265 GM crops 174, 217, 224 GM food aid 175–6 governance 220–21 NGOs 217–21, 222, 224 Africa Harvest International Foundation (AHarvest) 224, 226, 228 African Agricultural Technology Foundation (AATF) 217, 225 African Biotechnology Stakeholders Forum (ABSF) 225, 226–7, 228 African Seed Biotech Program 223 African Union (AU) 176, 177, 223 AgBio 248 AHarvest 224, 226, 228 AIDS 112, 122, 123, 126, 156 AIDS Action Council 123 aims of book 11 Alibek, Ken 145 All-African Congress on Biotechnology 223, 225 Alpha-1 Foundation 196, 200 Anderson, Robert S. 159 Anti Terrorism Crime and Security Act 2001 [UK] 137 anticommons 206 Aquinas, St Thomas 95 ARdS see Sikasso Regional Assembly Aristotle 95 Association des Organisations Professionnelles Paysannes (AOPP) 251

ataxia telangiectasia 194 auditors 149 Australia 116, 241 Australia Group 136 Aventis 165 AZT 112 Bacon, Francis 145, 149 Barry, Brian 24, 32, 40 Beck, Ulrich 133, 141–4, 145, 148, 149 Bellivier, Florence 211 Benatar, Solomon 43 Bentham, Jeremy 25–6 Berg Report 154 Biggs, Stephen D. 156 biobanks 8, 56–9 see also UK Biobank biolaw 93 biological weapons 133, 137, 138, 143, 144, 145 Biological Weapons Convention 1972 (BWC) 133, 134, 136 General Purpose Criteria 145–6 biosafety Africa 13, 171–90, 265 definitions 147, 183, 184 biosciences see life sciences biosecurity definition 147 United Kingdom 12, 133–52, 264, 267 biotechnology see life sciences Biotechnology Research in an Age of Terrorism ... 2004 138 Biotechnology Trust Africa (BTA) 226 Black Box warnings 123 black boxing 182 Blackburn with Darwen Citizens Jury 253 Blakemore, Colin 99 blockbuster orphans 124 Bolivia 155 Booz-Allen 117 Botswana 181, 182, 183

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bottom up 9, 24 Boyd, Kenneth M. 194 Brazier, Margaret 81 breakthrough innovation 118–19 Bristol-Myers Squibb 165 Brocher Foundation xv Brown, Gordon 239 Brown, Louise 80 Bruce, Ann ix, 12, 54–5 Bryant, Peter ix, 13–14, 246, 263, 265, 267 BSE 65 Bt crops see GM crops Buchanan, Allen E. 30, 33, 34–5 Buffet Foundation 217 Bush, George D.W. 136 California, University 198 Cambridge, University 241 Canada 116 Canavan Foundation 196–9 cancer 112, 122, 123, 143 capitalism 27, 31, 40 cardiofaciocutaneous syndrome 204 Cartagena Protocol on Biosafety 161, 172, 180 Catalona case 210 Center for International and Security Studies at Maryland 136 Centro Internacional de Mejoramiento de Maíz y Trigo (CIMMYT) 157–8, 160 CFC International 204 change, technological 9–10, 107, 264 Chataway, Joanna 6–7 choice 67–8 Chromosome 18 Registry and Research Society 194 Citizens’ Inquiry into the National DNA Database [UK] 241, 243 citizens’ juries 239–59 Citizens’ Space for Democratic Deliberation see l’ECID civil society 220, 229 clinical trials website 122 cloning, human 92 cognitive justice 252–3 Cohen, Gerald A. 36

Cohen, June Maslow 30, 40 Cold War 110, 133 collaboration 52, 74 see also transnational governance Collective Environmental Farming 228–9 colonial legacy, French 253–4 commercialization 70, 71, 196, 197, 198 Committee of Inquiry into Human Fertilisation and Embryology see Warnock Committee commons, tragedy of 206 communitarianism 26–7, 38–40 Compagnie Malienne de Développement des Textiles (CMDT) 247, 249 consultation 69, 73, 74 Consultative Group for International Agricultural Research (CGIAR) 158, 160 contracts 200, 202, 209–11 convergence 182 Cooke, Bill 245 Coordination Nationale des Organisations Paysannes du Mali (CNOP) 249 cosmopolitanism 43–4, 45 Costello syndrome 204 cotton 217, 225, 249, 254 Cure Autism Now 200 Daniels, Norman 73 Davies, Celia 242 De Melo-Martin, Immaculada 34 DebRA International 196 deCODE genetics 57 deliberative governance 240–41 developing countries 12–13, 153–69 see also under names of individual countries GM crops 153 governance 153–5, 157, 167, 265, 266 patient groups 210 public-private partnerships 125 Devlin, Patrick 93 difference principle 23, 32, 35 difluoromethylornithine see eflornithine diseases infectious 137, 143, 145 rare 110

Index

distributive justice see justice Diver, Colin S. 30, 40 DNA database 243 Donaldson, Sir Liam 99 drug regulation [US] see Food and Drug Administration dual-use technologies 140 Dupré, John 145 Dutch Government 225, 226 Dworkin, Ronald 24, 26, 32–3, 35, 81, 93 Earle, Timothy C. 65–6 l’ECID 13–14, 241, 246–56, 266, 267 Economic and Social Research Council (ESRC) xv ESRC Innogen Centre xv, 114 Economic Community of West African States 217 eflornithine 12–13, 164–6, 167 egalitarian liberalism 23–4, 32–5 Eisenberg, Rebecca S. 206 Elster, Jon 27 embryos (human) 83–92, 97, 99 employment discrimination 28–9, 35, 36, 37–8, 40 Engels, Friedrich 27 Enhanced Border Security and Visa Entry Reform Act 2002 [US] 139 equality see inequality Espace Citoyen d’Interpellation Démocratique see l’ECID Ethics+ 12, 52, 72, 73, 260, 269 ethics committees 71, 72 eugenics 30–1, 34–5, 36–7, 39 European Citizens’ Panel on the future of rural areas 243–4 European Union (EU) 5, 186, 243 Committee for Orphan Medicinal Products (COMP) 116 GM crops 161, 162–3, 222 NGOs 222–3 orphan drugs 116, 125 Rare Disease Task Force (RDTF) 116 Evans v. Amicus Healthcare Ltd 94 evidence-based decision-making 1, 2, 52, 58–9, 73–4, 164, 272 extension services 155

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Farrelly, Colin 33 fast track programme 12, 109, 114–19, 121, 123, 126–9, 268–9 definition 112–13 feminists 81–2 Fink Report 138 food aid see GM food aid Food and Drug Administration (FDA) [USA] 7–8, 9, 12, 109, 268–9 Amendments Act 2007 (FDAAA) [US] 111, 113 Continuous Marketing Application (CMA) pilot programme 122 Office of Orphan Products Development (OOPD) 111 Priority Review 117, 118 Food and Drug Administration Modernization Act 1997 (FDAMA) [US] 112–13, 122 Food Standards Agency [UK] 65, 241, 243, 251–2 Foreign and Commonwealth Office [UK] 139 France, colonial legacy 253–4 Gates Foundation 217, 224 Gaventa, John 244 Genetic Alliance Biobank 196, 204 genetic databanks see biobanks genetic discrimination 21, 28–30, 32, 37–8, 45 Genetic Interest Group (GIG) 195 genetically modified see GM Geneva Protocol 1925 133 genomics 8–9 definition 28 innovation 126 Germany 223, 241 Global Genomics Initiative (GGI) 44 globalization 107, 133, 135, 140, 141, 167, 171 GM crops 5, 8, 54 Africa 174, 217, 224 Bt toxin 161 cotton 217, 254 developing countries 153 European Union 161, 162–3, 222 Kenya 217, 225–9

278


Mali see l’ECID NGOs 217 United Kingdom 65, 222, 241, 243, 251–2 United States 161 GM food aid Africa 174, 175–6 Zambia 12, 161–4, 166–7, 176 GM Nation? [UK] 222, 251 Goetz, Anne Marie 245–6 Goita, Mamadou 252 Golde, Dr 198 Gorman, Theresa 86 Gorner, Peter 201 Gottweis, Herbert 8–9, 28, 42 governance 108–9, 167, 219–21, 240, 265–6 Africa 220–21 definitions 2–3, 22, 172, 218, 261, 262 deliberative 240–41 developing countries 153–5, 157, 167, 265, 266 political nature of 266–8 reflexive 12, 51, 52, 56, 66, 68, 72–3, 146 styles of 240 tools 4–5, 10 transnational 173–5, 176–9, 180–85, 186, 187 typology 5 government definitions xiii, xiv, 262 joined-up 11–12, 21, 22, 42–3, 45 Graham, David 7 GRAIN 221 Graz, Jean-Christophe 179 Green Revolution 156, 158–9, 160 Greenaway, John 4 Greenberg v. Miami Children’s Hospital 196–9, 201, 203, 204, 205, 206, 207, 208, 210 Greenpeace 162, 221, 241 group membership theory 208 Gulf War, Second 134 Habermas, Jürgen 36 Hagendijk, Rob 2, 5, 240 Hapgood, John (Archbishop of York)

87 Harmon, Shawn H.E. ix, 12, 263, 264, 270, 271 Harrar, J. George 158 Harris, John 81 Harsh, Matthew ix, 13, 45, 155, 263, 265, 267 Hart, Herbert L.A. 93 Hawaii, University 200, 202, 203, 210 Health, Department of [UK] 60–61 Health and Safety at Work Act 1974 [UK] 147 Health and Safety Executive [UK] 147 Hedgecoe, Adam 149 Heller, Michael A. 206 Hereditary Disease Foundation 194 heterarchy 11, 22, 23, 24, 25, 32, 45 definition 163 Hickey, Samuel 184 hierarchy 10, 22, 26 High Level Panel on Modern Biotechnology 223, 224 HIV see AIDS Hobbes, Thomas 45 Hofstede, Geert H. 182 Holocaust 30 Horst, Maja 240, 243 Horton, Richard 7 Human Fertilisation and Embryology Act (HFEA 1990) [UK] 12, 79–80, 88, 89, 90–101, 264, 270 Human Fertilisation and Embryology Authority (HFEA) 90–91, 98–9 Human Fertilisation and Embryology (Research Purposes) Regulations 2001 [UK] 79–80, 88, 89 Human Genetics Commission 71 Human Reproductive Cloning Act 2001 [UK] 92 Human Tissue Act 2004 101 Hunt, Adrienne 75 Huntington’s disease 194 hybrid research 98, 99 Icelandic Health Sector Database 57, 67 Illegal Immigration Reform and Immigrant Responsibility Act 1996 [US] 139

in vitro fertilization (IVF) 21, 30, 34, 35, 38, 80–81, 85 India, citizens’ juries 241, 244–6 industrial pollution 142 industry involvement 5–6, 10 inequality 31, 40, 41–2 infectious diseases 137, 143, 145 infertility 80–81 information technology 107 Innogen Centre see ESRC Innogen Centre innovation breakthrough 118–19 linear model 156, 159 STI 107, 108 Institut d’Economie Rurale (IER) 248, 253, 254 Institute for Public Policy Research (IPPR) 241 Institute of Development Studies (IDS) 245 insurance discrimination 28–9, 35, 36, 37–8 Interagency Committee on Drugs of Limited Commercial Value [US] 110 interests 53, 54–6, 264 biobanks 59 UK Biobank 63, 68, 269 Interim Licensing Authority 85 International Agricultural Research Centres (IARCs) 158, 160 International Aids Vaccine Initiative 156 International Council for Life Sciences 136 International Development, Department for (DFID) [UK] 245 International Rice Research Institute (IRRI) 157–8, 159, 160, 166 International Service for the Acquisition of Agri-Biotech Applications (ISAAA) 225, 226–7, 228 Irwin, Alan 2, 5 Israel 116 IVF see in vitro fertilization Japan 116, 120, 125 Jessop, Bob 22, 31

Index

279

joined-up government 11–12, 21, 22, 42–3, 45 Jordan, Andrew 3, 262 journal publication 136, 138, 146 justice 11–12, 21–49, 95, 166 cognitive 252–3 Juvenile Diabetes Research Foundation 200 Kanellopoulou, Nadia ix–x, 13, 263, 270 Kant, Immanuel 95 Kazancigil, Ali 23 Keeley, James 253–4 Kelsen, Hans 95 Kennet, Lord 87 Kenya 162, 218, 221, 267 GM crops 217, 225–9 National Biotechnology Policy 226–7, 231, 232 NGOs 13, 224–31 participation 228–30, 232–3 Kenya Agricultural Research Institute (KARI) 227–8 Kidney Cancer Association 122 King’s Fund Policy Unit 241 Krause, Keith 133 Kymlicka, Will 25, 26–7 Lauderdale, Earl of 87 Laurie, Graeme x, 12, 51, 198, 263, 264, 267, 269, 271 Lesotho 182 Levidow, Les 222 Levitt, Mairi 65 libertarianism 24–5, 35–7 life sciences, use of terminology 11 linear model of innovation 156, 159 Locke, John 35–6 luck 33–4 Lyall, Catherine x, 9, 12, 14, 23 McFarlane v. Tayside Health Board 94 MacKenzie, Donald 146 McLeish, Caitríona x, 12, 263, 264, 267 McNair Wilson, Sir Michael 87 Malawi 161, 162, 163, 176, 182–3 Mali’s Farmer’s Jury see l’ECID market pull 107, 111, 115, 116

280


Marketing Research Standards Board (MRSB) 243 Martin, Paul 149 Marx, Karl see Marxism Marxism 27, 40–42, 46 Mason, John Kenyon 198 Matalon, Reuben 197 Médecins Sans Frontières (MSF) 165 media 107 mediation 54 Medical Research Council (MRC) 61, 85, 99 Meeting of Minds, European Citizens Deliberation on Brain Science 241 melarsoprol 164 Merck 7 Merrell Dow Pharmaceuticals 164–5 Merz, Jon 201, 205 Miami Children’s Hospital see Greenberg Mill, John Stuart 25–6, 93, 95 Millennium Development Goals (MDGs) 154, 173 Milne, Christopher-Paul x, 12, 98, 263, 264, 268–9, 271 Mittra, James 29 Modernising Government agenda 52 Mohan, Giles 184 Monsanto 217, 225, 248, 253 Moore, Adam D. 35–6 Moore v. Regents of the University of California 198, 210 Moran, Mary 118, 119 mouse-pox 138, 144 Mozambique 161, 162, 163, 176, 182–3 Mugwagwa, Julius T. 263, 265, 270 Mulkay, Michael 97 multi-national companies 108 multilateralism 136 Mwanawasa, Levy 162 Nagel, Thomas 27, 44, 45 Nairobi Declaration 223 Nanojury 241, 242 nanotechnology 241 NAPE 196 National Agricultural Research Systems (NARS) 158, 159–60

National Biocontainment Laboratories [USA] 137 National Biosafety Committee (NBC) [Kenya] 226, 227, 230–1 National Cancer Society [US] 123 National Institute of Allergy and Infectious Diseases (NIAID) [US] 137 National Organization for Rare Disorders (NORD) [US] 110, 120–21, 129 National Security Decision Directive 189 [US] 139–40 National Tay-Sachs and Allied Diseases Association (NTSAD) [US] 197 Natsios, Andrew 162 natural primary goods (NPG) 33, 39–40 Nazis 30 needs principle 40–41, 42, 46 networks, policy see policy networks new molecular entities (NMEs) 118–19, 123 New Partnership for Africa’s Development (NEPAD) 176, 177, 223, 225 New Zealand 116, 241 Newman, Janet 4 NGOs see non-governmental organizations Nielsen, Paul 162–3 Nightingale, Paul xi, 12, 263, 264, 267 Noiville, Christine 211 Nolke, Andreas 179 non-governmental organizations (NGOs) 44–5, 155, 187, 217–37, 265 Africa 217–21, 222, 224 definition 219 Europe 222–3 GM crops 217 Kenya 13, 224–31 public-private partnership involvement 217, 221 security role 134 North, definition 218 Nozick, Robert 24–5, 35, 36 nuclear power consultation [UK] 243 Nuffield Council on Bioethics 99 Nussbaum, Martha Craven 44

Index

Odame, Hannington 227 O’Neill, Onora 43–4, 65 Open Forum on Agricultural Biotechnology 225 Opinion Leader Research 241, 243 Organization for Economic Cooperation and Development (OECD) 186 Organization of African Unity (OAU) 177 Orphan Drug Act 1983 [US] 110–11, 120, 122–3 orphan products 12, 109, 113, 114–16, 118–20, 122–9, 268–9 definition 111 other-regard 55, 68 Paarlberg, Robert 153 Papaioannou, Theo xi, 11–12, 14, 263, 267, 269 parthenogenesis 91 participation 9, 43, 68–9, 70, 272 see also citizens’ juries Kenya 228–30, 232–3 pathogens 143, 145, 146 patient advocacy groups 13, 110, 121, 122, 193–215, 269 achievements 195 developing countries 210 professionalism 194–5 Patriot Act 2001 [US] 136 pentamidine 164 Pentland, Brian T. 149 personhood 80, 84, 87, 91 Peters, B. Guy 22, 42, 263, 264, 266 Pierre, Jon 22, 42, 263, 264, 266 Pimbert, Michel 245 Pioneer Hi-Bred v. Holden Foundation 198 Polanyi, Karl 157 Policy, Ethics and Life Sciences Research Institute (PEALS), Newcastle University 241 policy-making 1–17, 174, 272 policy networks 4, 10, 109, 126, 128, 262, 266 see also public-private partnerships polio virus cDNA 138, 144 pollution, industrial 142

281

poverty 43 Powell, Enoch 86 Power, Michael 149 Prajateerpu 241, 244–6, 253 pre-embryos 87 pre-implantation genetic diagnosis (PGD) 21, 30, 34, 35, 38 precautionary principle 161 President’s Emergency Plan for AIDS Relief (PEPFAR) 122 Pretty, Jules 244 procreative autonomy 81 procreative beneficence 34, 38 Program for Biosafety Systems (PBS) 225 Proliferation Security Initiative (PSI) 140 pseudoxanthoma elasticum see PXE International public engagement see participation Public Health Security and Bioterrorism Preparedness and Response Act 2002 [US] 136–7 Public Health Service (PHS) Task Force [US] 110 public interest see interests public participation see participation public-private partnerships 125 in developing countries 156 NGO involvement 217, 221 pull, market 107, 111, 115, 116 push, science 107, 111, 115, 116 PXE International 194, 196, 200–207, 208, 209, 210 R (on the application of Quintaville) v HFEA 88 Raguran, Shetty 254 Rao, Arti 198–9, 210, 211 rare diseases 110 rationality 70 Rawlinson, Lord 87 Rawls, John 23–4, 32, 33, 34, 35 Rayner, Steve 222 R&D 108, 109, 110, 126, 127 Reason, Peter 245 reflexive governance see under governance regional collaboration see transnational governance

282


regulation xiv, 2, 261 medicines [US] 107–32 reproductive medicine, 79–104 see also in vitro fertilization Rhodes, R.A.W. 24, 263–4, 271 rice 12, 157–60 Richards, Paul 244 risk 133, 141–4, 145, 146–7, 148–9, 182, 183, 224 Robertson, Lord 87 Ropars, Anne-Laure 118, 119 Rosenberg, Justin 133, 140, 141 Royal College of Obstetricians and Gynaecologists (RCOG) 85 Sagasti, Francisco 244–5 Salamon, Lester M. 9 Savulescu, Julian 34, 38 Scanlon, Thomas 24, 33 science, disunity of 145, 148 science, technology and innovation (STI) 107, 108 science push 107, 111, 115, 116 Scoones, Ian 253–4 security, outsourcing 134 self-organization 31 self-ownership 35–6 self-regulation 107, 108 significant biologics (SBs) 118–19, 123 Sikasso Regional Assembly 246, 248, 252 Singapore 116, 125 Singh, Jasber 242 sleeping sickness 164 small and medium sized business enterprises (SMEs) 108, 126 smallpox see variola virus Smith, Graham 242, 244 Smith, James xi, 12–13, 14, 240, 256, 263, 265, 268 social justice see justice social movements 251 social primary goods (SPG) 33, 34, 39–40 social theory 141 somatic cell nuclear transfer (SCNT) 91 South, definition 218 South Africa 162, 182, 183, 217 South Korea 116

Southern African Development Community (SADC) 174, 175, 176, 177, 185 SPGs 33, 34, 39–40 Spinardi, Graham 146 stakeholders 1, 2, 8, 51, 57, 120–22 definition 56 state, role of see government state sovereignty 141 steering not rowing 6, 111, 264 stem cells 5, 8 innovation 126 research 88, 89, 90, 98, 99 Stevens, Candice 185 Stirling, Andrew 146 Stoker, Gerry 43, 264 students, vetting schemes 139, 146 suramin 164 surrogacy 85 Surrogacy Arrangements (Amendment) Bill 86 Swaziland 182 Sweden 57 Syndicat des Producteurs de Coton de Vivriers (SYCOV) 249, 251 Syndicat pour la Valorisation des Cultures Cotonniéres et Vivriéres (SYVAC) 250 Syngenta 248, 253, 254 Tait, Joyce xi–xii, 8, 12, 23, 54–5, 263, 264, 268–9, 271 Talking Energy 243 Taylor, Harry 240 technological change 9–10, 107, 264 Temple, Rober, 117 terrorism 134, 136, 140 Terry, Patrick 203 Terry, Sharon 195, 202, 203, 204 test-tube babies see in vitro fertilization top down 9, 24, 36, 108, 109–10, 268–9 Touré, Boubacar 247 tragedy of the anticommons 206 tragedy of the commons 206 transnational governance 173–5, 176–9, 180–85, 186, 187 Traoré, Alimata 251 Traoré, Moussa 249

Index

treatment INDs (investigational new drugs) 121 Tripoli Declaration 223 trust reproductive technology 85 UK Biobank 64–6, 67 trypanosomiasis 164 Tufts Center for the Study of Drug Development (Tufts CSDD) 114, 117, 118, 119 Tvedt, Terje 232 Uganda 155, 165 UK Biobank 12, 57–8. 59–73, 74, 269 Ethics and Governance Council 51, 60, 61, 62, 64, 66, 69, 70, 71–2 Ethics and Governance Framework (EGF) 60, 61–2, 63, 66, 68, 69, 70 funders 61 interests 63, 68, 269 Interim Advisory Group 61 public engagement 70, 71 purpose 60 trust 64–7 values 57–8, 63, 66, 67–8, 269 Uman Genomics 57 Unborn Children (Protection) Bill 1985 86 United Kingdom 5 biosecurity 12, 133–52, 264, 267 GM crops 222, 241, 243, 251–2 pharmaceutical industry 9 United Nations 136 Millennium Development Goals (MDGs) 154, 173 Security Council Resolution 1540, 2004 140 UN Millennium Report 166 United Nations Educational, Scientific and Cultural Organisation (UNESCO) 44 United Nations Environment Programme (UNEP) 225, 226, 231 United States 5 Agency for International Development (USAID) 162, 225, 248, 253, 254–5 citizens’ juries 241

283

drug regulation see Food and Drug ... GM crops 161 Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA Patriot) Act 2001 136 utilitarianism 25–6, 37–8 values 53, 54–6, 70, 73–4, 264 agricultural innovation 222 biobanks 57–9 HFEA 93–5, 99 UK Biobank 57–8, 63, 66, 67–8 Van der Velden, Maja 252–3 Vaniqa 165 variola virus 138, 144 Veneman, Ann 162 Vioxx 6–8, 264 Visvanathan, Shiv 252, 263 Voluntary Licensing Authority (VLA) 85 Wakeford, Tom 242, 245 Wales, Corinne 242, 244 Walton, Lord 88 Walzer, Michael 38, 39 Wambugu, Florence 224, 227, 232 Warnock, Mary 82, 99 Warnock Committee 82–5, 86, 90, 91, 95 Wassenaar Agreement 136 Water Efficient Maize for Africa 217 weapons biological see biological weapons of mass destruction (WMD) 140 Weber, Max 70 Weldon, Dave 138 welfare state 26 Wellcome Trust (WT) 61 what works 23, 52, 53, 113, 128 Whittall, Hugh 99 Williams, Michael C. 133, 140 Winterton, Ann 89 World Bank 154 World Health Organization (WHO) 164, 165 York, Archbishop of (John Hapgood) 87

284


Zambia biosafety 182–3 GM food aid 12, 161–4, 166–7, 176 Zerbe, Noah 162

Zimbabwe 161, 162, 176, 183 Farmers’ Jury 241 Zoellnick, Robert 162–3

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