Governing Public Health: EU Law, Regulation and Biopolitics (Modern Studies in European Law)

This book contributes towards EU studies and the growing discourse on law and public health. It uses the EU’s governance of public health as a lens through which to explore questions of legal competence and its development through policy and concrete techniques, processes and practices, risk and security, human rights and bioethics, accountability and legitimacy, democracy and citizenship, and the nature, essence and ‘future trajectory’ of the European integration project. These issues are explored first, by situating the EU’s public health strategy within the overarching architecture of governance and subsequently by examining its operationalisation in relation to the key public health problems of cancer, HIV/AIDS and pandemic planning. The book argues that the centrality and valorisation of scientific and technical knowledge and expertise in the EU’s risk-based governance means that citizen participation in decision-making is largely marginalised and underdeveloped – and that this must change if public health and the quality, accountability and legitimacy of EU governance and its regulation are to be improved. Subsequently the book goes on to argue that the legitimating discourses of ethics and human rights, and the developing notion of EU (supra-)stewardship responsibility, can help to highlight the normative dimensions of governance and its interventions in public health. These discourses and dimensions provide openings and possibilities for citizens to power ‘technologies of participation’ and contribute important supplementary knowledge to decision-making. Mark L Flear is a Lecturer in Law at Queen’s University, Belfast. ’In defending the case for making public health policies more responsive and robust through citizen participation, the author charts the growing role of the EU as an actor in this domain and its formal legal competence. The discussion on the overarching EU health governance architecture and health strategy is accompanied by wonderfully written case studies on cancer, HIV/AIDS and other pandemics and serious cross-border threats to health. Risk, security, regulation, human rights and bioethics, all receive careful attention ... Governing Public Health defies disciplinary boundaries; it brings together insights from sociology, political science, law and critical legal studies in order to uncover the complex regulation of public health in the European Union. It is a timely book which will appeal to scholars of the European Union in many disciplines. It provides an indispensable roadmap to the links between law, (bio)politics and citizen engagement in the regulation of public health’. From the ’Foreword’ by Professor Dora Kostakopoulou, School of Law, University of Warwick ’Governing Public Health stands on its own, as it masterfully blends together law, politics, sociology and numerous other disciplines to come up with a picture of the EU as an agent of biopolitics, which is as plausible as it is potentially disturbing. The book is an attack on the distortions and pitfalls of the dominant risk-based model of public health governance, representing the first – long overdue! – biopolitical analysis of EU law. Flear’s crusade is to overturn our accepted vision of managing public health by arguing that the governed have the capacity to contribute important supplementary knowledge on the distortions and pitfalls in order to improve governance. This book deserves all respect and admiration.’ Professor Dimitry Kochenov, University of Groningen ’This book focuses on participation as a possible mediator of the relationship between law, on the one hand, and science and technology on the other. It argues that the tension between the democratic and technocratic aspects of regulation could, perhaps, be reduced by the use of participatory processes. That argument has a wider resonance than the public health field on which the book concentrates. EU scholars in the diverse fields where expertise and preferences circle each other nervously will want to study and apply the book’s central ideas, and will find that they are clearly and attractively presented, and gain authority from the range of theory on which Flear relies.’ Professor Gareth Davies, VU University Amsterdam Cover 1 Half-title 3 Title 5 Copyright 6 Foreword 7 Acknowledgements 9 Contents 11 Table of Cases 15 Table of Instruments and Legislation 17 1. Context, Approach and Overview 27 I. Introduction 27 A. Starting Points 28 B. Research Agenda and Aims 29 C. Key Arguments and Next Steps 32 II. Law, Public Health and Participation 35 A. Law and Public Health: A Very Brief Overview 35 B. Citizen Participation 41 C. Taking Citizen Participation Seriously 45 III. Governing in Late Modernity: Theory, Concepts and Methods 46 A. Technologies of Governing: Risk, Freedom/Security and Governmentality 46 B. Regulating Risk 48 C. Neoliberalism 52 D. Biopolitics and ‘The Governed’ as Citizens 54 IV. Overview 56 Part I: Governing Public Health 61 2. EU Public Health Governance: From the Overarching Architecture to the Health Strategy 63 I. Introduction 63 II. The EU and Public Health: Legal Competence, Governance and Responsibility 64 A. Legal Competence 64 B. The Overarching Architecture and Programmatic Priorities of EU Governance 70 III. Operationalising the Overarching Strategy in the Field of Public Health: Together for Health 74 A. The Market-Oriented Rationale 75 B. Overview of Principles and Objectives 77 C. Health in All Policies (HIAP) 80 i. Technologies of Knowledge-based Policy-making: Impact Assessment 82 ii. Technologies of Agency and Performance: Monitoring, Measuring and Evaluating 89 D. The EU as a Security Actor and the Production of Legitimacy 94 IV. Structured Cooperation: Public Health Policy Implementation and the Health Programmes 96 A. Structured Cooperation 96 B. EU Health Programmes: Steering Through Funding 98 V. Conclusion 102 3. Cancer 104 I. Introduction 104 II. From the Overarching Architecture of Governance to Action Against Cancer: European Partnership via Together for Health 105 III. European Partnership for Action Against Cancer 109 A. Overview of Rationale and Objectives 109 B. Areas and Actions for a ‘Comprehensive Policy Response’ 113 i. The Most Cost-effective Response 113 ii. Bolstering Technologies of Knowledge-based Policy: Identification and Dissemination of Good Practice 116 iii. Cooperation and Coordination in Cancer Research as a Technology of Knowledge Production 118 iv. Facilitating Technologies of Agency and Performance: The Benchmarking Process 123 C. The Partnership Approach as Steering 124 i. Broad Overview 124 ii. Work Packages 126 iii. Extending and Deepening Governance: National Cancer Plans 132 IV. Conclusion 133 4. HIV/AIDS 135 I. Introduction 135 II. From the Overarching Architecture of Governance to Combating HIV/AIDS within the EU and in the Neighbouring Countries — Reflecting Together for Health 136 III. Taking Action: Combating HIV/AIDS within the EU and in the Neighbouring Countries 141 A. Mapping ‘HIV in Europe’ : Constituting a Problem for EU Governance 141 B. Key Contours of the EU’ s Governance 146 i. Distributed Responsibilities 146 ii. The Centrality of Prevention 151 iii. Most ‘At Risk’ Regions and Groups 152 IV. Technologies for the Gathering and Production of Knowledge 159 A. Surveillance 159 B. Pharmaceuticals and Other Medical and Technological Responses 164 V. Conclusion 167 5. Pandemics and Beyond 170 I. Introduction 170 II. From the Overarching Architecture of Governance to Pandemic Influenza Preparedness—Reflecting Together for Health 172 III. Governing the Future Through Preparedness Planning 177 A. Ensuring Preparedness Through Coordination Based on Knowledge of Member States’ Plans 177 B. Risk Assessment and Management 180 i. Risk Assessment and Further Technologies for the Gathering and Production of Knowledge 180 ii. Risk Management—And the Importance of Medical Countermeasures and Pharmaceutical Fixes 184 C. Communication 188 IV. Conclusion 190 Part II: Enhancing Citizen Participation in Governing Public Health 193 6. Citizen Participation in Governing: Discursive Resources, Tools and Spaces 195 I. Introduction 195 II. Summary of the Findings So Far 196 A. The Centrality of Risk 196 B. Neoliberal Underpinnings as the Structuring Themes of the Policy Domain 200 III. Risk, Public Health and Citizen Participation 203 IV. Opening Discursive Space and Powering Technologies of Participation 212 A. Openings and Possibilities for Citizen Participation 212 B. Resources for Participation: Human Rights, Bioethics and (Supra-)Stewardship Responsibility 216 i. Human Right and Bioethics 216 ii. (Supra-)Stewardship Responsibility 221 iii. Towards Participation 224 V. Conclusion 225 7. Querying Framing and Knowledge Production: Risk, Numbers, Measurement and Evaluation 227 I. Introduction 227 II. Querying Risk 228 A. Framing, Knowledge and Responses 228 B. Skewing Attention and Resources Towards Consequences 231 III. Querying Scientific and Technical Knowledge Production 235 A. Looking More Closely at Knowledge Production 235 B. Steering Governance Through Indicators 238 i. Instruments of Governance 238 ii. Salient Features 241 iii. Demanding Alternatives 243 IV. Clinical Trials 246 A. Producing Data in Support of Magic Bullet Responses and Pharmaceutical Fixes 246 B. Situating Clinical Trials in EU Governance 248 C. Informed Consent 252 D. Designing Clinical Trials 256 E. Using Placebos in Clinical Trials Abroad 259 F. Clinical Trials Abroad and the European and Developing Countries Clinical Trials Partnership 263 G. Contesting Regulatory Design and Demanding Redesign 265 V. Conclusion 266 8. Querying Interventions: Magic Bullet Responses and Technological Fixes 268 I. Introduction 268 II. Interventions 270 A. General Reflections on Vulnerability 270 i. A Brief Note on Surveillance 270 ii. Wider Interventions and the Hierarchy of Public Health Problems 272 iii. Framing, Responsibility and Accountability 280 B. Pharmaceuticalisation and Vulnerability 281 III. Pharmaceuticals Abroad: Access, Prioritisation and Triage 283 A. Access 283 i. Combating Barriers and the Importance of EU Trade Policy 283 ii. Patents as Barriers to Access 286 iii. Alternative Mechanisms 290 B. Prioritisation and Triage 291 i. The View ‘On the Ground’ 291 ii. Triage, Valuing and Access 294 IV. Conclusion 296 9. Conclusion 299 Select Bibliography 304 Index 310 Présentation de l'éditeur : "This book contributes towards EU studies and the growing discourse on law and public health. It uses the EU's governance of public health as a lens through which to explore questions of legal competence and its development through policy and concrete techniques, processes and practices, risk and security, human rights and bioethics, accountability and legitimacy, democracy and citizenship, and the nature, essence and 'future trajectory' of the European integration project. These issues are explored first, by situating the EU's public health strategy within the overarching architecture of governance and subsequently by examining its operationalisation in relation to the key public health problems of cancer, HIV/AIDS and pandemic planning. The book argues that the centrality and valorisation of scientific and technical knowledge and expertise in the EU's risk-based governance means that citizen participation in decision-making is largely marginalised and underdeveloped - and that this must change if public health and the quality, accountability and legitimacy of EU governance and its regulation are to be improved. Subsequently the book goes on to argue that the legitimating discourses of ethics and human rights, and the developing notion of EU (supra- )stewardship responsibility, can help to highlight the normative dimensions of governance and its interventions in public health. These discourses and dimensions provide openings and possibilities for citizens to power 'technologies of participation' and contribute important supplementary knowledge to decision-making." This Book Contributes Towards Eu Studies And The Growing Discourse On Law And Public Health. It Uses The Eu's Governance Of Public Health As A Lens Through Which To Explore Questions Of Legal Competence And Its Development Through Policy And Concrete Techniques, Processes And Practices, Risk And Security, Human Rights And Bioethics, Accountability And Legitimacy, Democracy And Citizenship, And The Nature, Essence And 'future Trajectory' Of The European Integration Project. These Issues Are Explored First, By Situating The Eu's Public Health Strategy Within The Overarching Architecture Of Governance And Subsequently By Examining Its Operationalisation In Relation To The Key Public Health Problems Of Cancer, Hiv/aids And Pandemic Planning.-- Context, Approach And Overview -- Eu Public Health Governance : From The Overarching Architecture To The Health Strategy -- Cancer -- Hiv/aids -- Pandemics And Beyond -- Citizen Participation In Governing : Discursive Resources, Tools And Spaces -- Querying Framing And Knowledge Production : Risk, Numbers, Measurement And Evaluation -- Querying Interventions : Magic Bullet Responses And Technological Fixes -- Conclusion. Mark L. Flear. Table Of Cases: Pages Xiii-xiv. Table Of Instruments And Legislation: Pages Xv-xxiii. Includes Bibliographical References (pages 278-283) And Index.