The Politics of Intellectual Property Rights and Access to Medicines
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1 The Politics of Intellectual Property Rights and Access to Medicines
2 International Political Economy Series General Editor: Timothy M. Shaw, Professor and Director, Institute of International Relations, The University of the West Indies, Trinidad & Tobago Titles include: Timothy Cadman QUALITY AND LEGITIMACY OF GLOBAL GOVERNANCE Case Lessons from Forestry Andrew F. Cooper and Timothy W. Shaw (editors) THE DIPLOMACIES OF SMALL STATES Between Vulnerability and Resilience Anthony Leysens THE CRITICAL THEORY OF ROBERT W. COX Fugitive or Guru? Valbona Muzaka THE POLITICS OF INTELLECTUAL PROPERTY RIGHTS AND ACCESS TO MEDICINES Mireya Solís, Barbara Stallings and Saori N. Katada (editors) COMPETITIVE REGIONALISM FTA Diffusion in the Pacific Rim Peter Utting and José Carlos Marques (editors) CORPORATE SOCIAL RESPONSIBILITY AND REGULATORY GOVERNANCE Towards Inclusive Development? International Political Economy Series Series Standing Order ISBN hardcover Series Standing Order ISBN paperback (outside North America only) You can receive future titles in this series as they are published by placing a standing order. Please contact your bookseller or, in case of difficulty, write to us at the address below with your name and address, the title of the series and one of the ISBNs quoted above. Customer Services Department, Macmillan Distribution Ltd, Houndmills, Basingstoke, Hampshire RG21 6XS, England
3 The Politics of Intellectual Property Rights and Access to Medicines Valbona Muzaka Lecturer in Global Politics, Department of Politics and International Relations, University of Southampton, UK
4 Valbona Muzaka 2011 Softcover reprint of the hardcover 1st edition All rights reserved. No reproduction, copy or transmission of this publication may be made without written permission. No portion of this publication may be reproduced, copied or transmitted save with written permission or in accordance with the provisions of the Copyright, Designs and Patents Act 1988, or under the terms of any licence permitting limited copying issued by the Copyright Licensing Agency, Saffron House, 6-10 Kirby Street, London EC1N 8TS. Any person who does any unauthorized act in relation to this publication may be liable to criminal prosecution and civil claims for damages. The author has asserted her right to be identified as the author of this work in accordance with the Copyright, Designs and Patents Act First published 2011 by PALGRAVE MACMILLAN Palgrave Macmillan in the UK is an imprint of Macmillan Publishers Limited, registered in England, company number , of Houndmills, Basingstoke, Hampshire RG21 6XS. Palgrave Macmillan in the US is a division of St Martin s Press LLC, 175 Fifth Avenue, New York, NY Palgrave Macmillan is the global academic imprint of the above companies and has companies and representatives throughout the world. Palgrave and Macmillan are registered trademarks in the United States, the United Kingdom, Europe and other countries. ISBN ISBN (ebook) DOI / This book is printed on paper suitable for recycling and made from fully managed and sustained forest sources. Logging, pulping and manufacturing processes are expected to conform to the environmental regulations of the country of origin. A catalogue record for this book is available from the British Library. A catalog record for this book is available from the Library of Congress
5 Contents List of Abbreviations Acknowledgements vii ix 1 The Politics of Intellectual Property Rights and Access to Medicines: Some Empirical and Theoretical Issues Some theoretical arguments on the nature of regimes and global governance Some organisational and methodological issues Sources 15 2 Intellectual Property Rights and Pharmaceuticals The forgotten justifications of IPRs Medicines and IPRs 23 3 Linking IPRs to Trade: The Making of TRIPs The trade regime of the 1980s Bringing the IPRs trade link into the trade regime Negotiating TRIPs ( ) 50 4 Contestations Post- TRIPs and the Emergence of the IP Access to Medicines Debate Implementing TRIPs: narrowing down exceptions and broadening private rights Establishing new linkages: the emergence of the IP- access to medicines debate The 2001 Doha Declaration on the TRIPs Agreement and public health 81 5 TRIPs Revisited The August 2003 decision: reneging on the Doha Declaration The December 2005 Amendment Shifting IP Issues between Regimes and Fora: Contestations Continued IP trade versus IP public health : the battle at the bilateral level 111 v
6 vi Contents 6.2 Beyond IP public health: other challenges to the IP trade link Conclusions 124 Notes 138 Bibliography 161 Index 177
7 Abbreviations AB ACTN ASEAN CBD CESC CPTech EC EEC EFPIA EFTA EU FAO FDI FTAA FTAs GATT GI GPE GSP HAI IFPMA IIPA IMF IP IPC IPE IPRs IR M&A MSF NAFTA NGOs OECD PGRs Appellate Body Advisory Committee on Trade Negotiations Association of Southeast Asian Nations Convention on Biological Diversity UN Covenant on Economic, Social and Cultural Rights Consumer Project in Technology European Commission European Economic Community European Federation of Pharmaceutical Industries and Associations The European Free Trade Association European Union UN Food and Agriculture Organisation Foreign Direct Investment Free Trade Area of the Americas Free Trade Agreements General Agreement on Tariffs and Trade Geographical Indicators Global Political Economy Generalised System of Preferences Health Action International International Federation of Pharmaceutical Manufacturers and Associations International Intellectual Property Alliance International Monetary Fund Intellectual Property Intellectual Property Committee International Political Economy Intellectual Property Rights International Relations Mergers and Acquistions Médecins sans Frontières North American Free Trade Agreement Non-Governmental Organisations Organisation for Economic Cooperation and Development Plant Genetic Resources for Food and Agriculture vii
8 viii Abbreviations PhRMA Pharmaceutical Research and Manufacturers of America PLT Patent Law Treaty R&D Research and Development SPLT Substantive Patent Law Treaty TABD Transatlantic Business Dialogue TRIPs Trade-Related Aspects of Intellectual Property Rights UNCTAD United Nations Conference on Trade and Development UNDP United Nations Development Programme UNESCO United Nations Educational, Scientific and Cultural Organisation UNICE Union of Industrial and Employers Confederations of Europe UNIDO United Nations Industrial Development Organization UPOV International Union for the Protection of New Varieties of Plants Convention USTR United States Trade Representative WHA World Health Assembly WHO World Health Organisation WIPO World Intellectual Property Organisation WTO World Trade Organisation
9 Acknowledgements One argument I make in this book is that intellectual products are best seen as social products rather than solely the result of individual efforts. The book itself lends support to this argument, for it would have been simply impossible to have completed this work without the intellectual and emotional support of so many people over the years. I should like to thank them all for their help and contribution. In particular, I would like to thank Professor Tony Payne for his enduring support and wise counsel and Dr. Tony Heron at the University of Sheffield, UK. I would also like to thank members of the Department of Politics, University of Sheffield, and of the Politics and International Relations Divisions at the University of Southampton, UK, for providing a great intellectual environment where I could discuss some of the ideas presented here. Gratitude, too, goes to the interviewees who generously gave their time to discuss some of the themes of this book with me. The usual caveats regarding remaining shortcomings apply. Professor Tim Shaw, Dr. Owain Williams, and Alexandra Webster and Renée Takken of Palgrave Macmillan have been immensely helpful in converting these ideas into final book form. My special thanks are also due to many friends and dear people who have generously given their time, love and support throughout the years. They are too many to mention here, but I should particularly like to thank my two wonderful sisters, Anila and Rovena, and brothers, Plarent and Alban, for being an unwavering source of love and kindness. I dedicate this book to the memory of my mother, Lefteria Prifti, who instilled in me the desire to learn and explore from very early on. ix
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