INCENTIVES FOR GLOBAL PUBLIC HEALTH potx

This page intentionally left blank INCENTIVES FOR GLOBAL PUBLIC HEALTH This portrait of the global debate over patent law and access to essential medicines focuses on public health concerns about HIV/AIDS, malaria, tuberculosis, the SARS virus, influenza and diseases of poverty. The essays explore the diplomatic negotiations and disputes in key inter- national forums, such as the World Trade Organ ization, the World Health Organization and the World Intellectual Property Organization. Drawing upon international trade law, innovation policy, intellectual property law, health law, human rights and philosophy, the authors seek to canvass pol icy solutions that encourage and reward worthwhile pharmaceutical innovation while ensuring affordable access to advanced medicines. A number of creative policy options are critically assessed, including the development of a Health Impact Fund, prizes for medical innovation, the use of patent pool s, Open Source drug development and forms of ‘creative capitalism’. thomas pogge is Leitner Profess or of Philosophy and International Affairs at Yale University, Professorial Fellow at the ANU Centre for Applied Philosophy and Public Ethics (CAPPE), Research Director at the Oslo University Centre for the Study of Mind in Nature (CSMN) and Adjunct Professor at the University of Central Lancashire. matthew rimmer is a s enior lecturer and A ssociate Director of Research at the ANU College of Law, and Associate Director of the Australian Centre for Intellectual Property in Agriculture. kim rubenstein is Profes sor and Director of the Cen tre for International and Public Law (C IPL) a t the ANU College of Law, Australian National University. CONNECTING INTERNATIONAL LAW WITH PUBLIC LAW This series of books flows from workshops bringing public and international lawyers and public and international policy makers together for interdisciplinary discussion on selected topics and themes. It aims to broaden both public and international laws’ understanding of how these two areas intersect. Until now, international and public law have mainly overlapped in discussions on how international law is implemented domestically. This series is unique in consciously bringing together public and internation al lawyers to consider and engage in each other’sscholarship. Series Editors Professor Kim Rubenstein, Australian National University Professor Thomas Pogge, Yale University Books in the series Incentives for Global Public Health: Patent Law and Access to Essent ial Medicines Edited by Thomas Pogge, Matthew Rimmer and Kim Rubenstein Sanctions, Accountability and Governance in a Globalise d World Edited by Jeremy Farrall and Kim Rubenstein INCENTIVES FOR GLOBAL PUBLIC HEALTH Patent Law and Access to Essential Medicines Edited by THOMAS POGGE, MATTHEW RIMMER and KIM RUBENSTEIN CAMBRIDGE UNIVERSITY PRESS Cambridge, New York, Melbourne, Madrid, Cape Town, Singapore, São Paulo, Delhi, Dubai, Tokyo Cambridge University Press The Edinburgh Building, Cambridge CB2 8RU, UK First published in print format ISBN-13 978-0-521-11656-5 ISBN-13 978-0-511-75004-5 © Cambridge University Press 2010 2010 Information on this title: www.cambridge.org/9780521116565 This publication is in copyright. Subject to statutory exception and to the provision of relevant collective licensing agreements, no reproduction of any part may take place without the written permission of Cambridge University Press. Cambridge University Press has no responsibility for the persistence or accuracy of urls for external or third-party internet websites referred to in this publication, and does not guarantee that any content on such websites is, or will remain, accurate or appropriate. Published in the United States of America by Cambridge University Press, New York www.cambridge.org eBook (NetLibrary) Hardback CONTENTS Contributors viii Series Editors’ Preface xvii Editors’ Preface xix Introduction: Access to essential medicines: public health and international law 1 thomas pogge, matthew rimmer and kim rubenstein PART I International trade 33 1. TRIPS and essentia l medicines: must one s ize fit all? Making the WTO responsive to the gl obal hea lth cr isis 35 rochelle c. dreyfuss 2. Th e TRIPS Waiver as a recognition of public health concerns in the WTO 56 andrew d. mitchell and tania voon 3. Public law challenges to the regulation of pharmaceutical patents in the US bilateral free trade agreements 77 hitoshi nasu 4. Global health and development: patents and public interest 101 elizabeth siew-kuan ng v PART II Innovation 133 5. Th e Health Impact Fund: better pharmaceutical innovations at much lower p rice s 135 thomas pogge 6. Th e Health Impact Fund: a critique 155 kathleen liddell 7. A prize system as a partial solution to the health crisis in the developing world 181 william w. fisher and talha syed 8. Innovatio n and insuffi cient evidence: the case for a WTO –WHO Agreement on Health Technology Safety and Cost-Effectiveness Evaluation 209 thomas faunce PART III Intellectual property 233 9. Opening the dam: patent pools, innovation and access to essential medicines 235 dianne nicol and jane nielsen 10. Open Source drug discovery: a revolutionary paradigm or a U topian model? 263 krishna ravi srinivas 11. Accessing and benefitsharingavianinfluenza viruses through the World Health Organization: a CBD and TRIPS compromise thanks to Indonesia’s sovereignty cla im? 284 charles lawson and barbara ann hocking 12. Th e Lazarus Effect: the (RED) Campaign and creative capitalism 313 matthew rimmer PART IV Healthcare 341 13. Be yond TRIPS: the role of non-state actors a nd access to essential medicines 343 noah benjamin novogrodsky vi contents 14. Securing health through rights 357 katharine g. young 15. The role of national laws in reconciling constitutional right to hea lth with TRIPS o bli gations: an exam ina tion of the Glivec patent case in India 381 rajshree chandra 16. Ti pping point: Thai compulsory licences redefine essential medicines debate 406 jonathan burton-macleod Bibliography 425 Index 486 contents vii CONTRIBUTORS Editors Having received his PhD in philosophy from Harva rd University, PROFESSOR THOMAS POGGE is Leitner Professor of Philosophy and International Affairs at Yale University, Professorial Fellow at the ANU Centre for Applied Philosophy and Public Ethics (CAPPE), Research Director at the Oslo University Centre for the Study of Mind in Nature (CSMN) and Adjunct Professor at the University of Central Lancashire. He is Editor for Social and Political Philosophy for the Stanford Encyclopedia of Philosophy and a member of the Norwegian Academy of Science. With support from the Australian Research Council, the BUPA Foundation and the European Commission, he currently heads a team effort towards developing a complement to the pha rmaceutica l patent regime that would improve access to advanced medicines for the poor worldwide. His recent publications include World Poverty and Hum an Rights, 2 nd edn. 2008; Global Justice and Global Ethics, both 2008; and John Rawls: His Life and Theory of Justice and Freedom from Poverty as a Human Right , both 2007. dr matthew rimmer is a senior lecturer and Associate D irector of Research at the ANU College of Law, and Associate Director of the Australian Centre for Intellectual Property in Agriculture. He holds a BA (Hons) and a University Medal in literature, and an LLB (Hons) from the Austral ian National University. Dr Rimmer received a PhD in law from the University of New South Wales for his dissertation on The Pirate Bazaar: The Social Life of Copyright Law. He is a member of the ANU Climate Change Institute and a director of the Australian D igital Allliance. Dr Rimmer is the author of Digital Copyright and the Consumer Revolution: Hands off my iPod (2007) and Inte llectual Property and Biotechnology: Biological Inventions (2008). He edited the viii [...]... brainstorm the call for papers This second workshop was entitled: Incentives for Global Public Health: Patent Law and Access to Essential Medicines.’ This title is inspired by Professor Pogge’s research programme, which explores institutional mechanisms that would create additional incentives to develop essential medicines while also ensuring real access to the resulting new products even for the world’s... the challenges of meeting the goal of ensuring access and innovation for needed health products and medical devices.27 In addition to these initiatives, substantial progress calls for an integrated solution that combines public law and international law elements to form an effective reform package: ‘Proposals should be developed for health- needs driven research and development that include exploring... medicines 5 global disease burden’.19 Pneumonia, diarrhoea, tuberculosis and malaria, which account for over 20 per cent of the global burden of disease, receive less than 1 per cent of all public and private funds devoted to health research.20 And diseases confined to the tropics tend to be the most neglected: of the 1556 new drugs approved between 1975 and 2004, only 18 were for tropical diseases and 3 for. .. 23 Drugs for Neglected Diseases Working Group, Fatal Imbalance: The Crisis in Research and Development for Drugs for Neglected Diseases (2001) also at www.msf.org/source/access/2001/ fatal/fatal.pdf, 10 See also Louis Currat, Andres de Francisco, Sameera Al-Tuwaijri, Abdul Ghaffar and Susan Jupp, Global Forum Health 10/90 Report 2003–2004 (2004) Ibid., 122 Pierre Chirac and Els Toreele, Global Framework... Essential Health R&D’ (2006) 367 The Lancet 1560; Drugs for Neglected Diseases Working Group, Fatal Imbalance, see above n 19, 10 See also Patrice Trouiller, Piero Olliaro, Els Torreele, James Orbinski, Richard Laing and Nathan Ford, ‘Drug Development for Neglected Diseases: A Deficient Market and a Public- Health Policy Failure’ (2002) 359 (9324) The Lancet 2188, 2189 See Oxfam International, ‘Investing for. .. competition for intellectual property rights; the clash between sovereign states over access to medicines; the pressing need to defend human rights, particularly the right to health; and the need for new incentives for research and development to combat infectious diseases as both an international and domestic issue 2 Connecting public and international law This volume is the second in a new series bringing public. .. the copycat industry for newer drugs For the world’s poor, this will be a double hit – cutting off the supply of affordable medicines and removing the generic competition that drives down the cost of brand-name drugs.’ (Editorial, ‘India’s Choice’, The New York Times, 18 January 2005) Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property, World Health Assembly 61st... establish minimum standards for protecting and enforcing intellectual property rights.30 In particular, members of the WTO are required to provide patent protection for pharmaceutical drugs for at least twenty years Nonetheless, the treaty does recognize the countervailing need of member states to protect public health Article 8 of the TRIPS Agreement declares: ‘Members may, in formulating or amending... protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this Agreement.’ The TRIPS Agreement contains a number of provisions designed to promote the public interest in the field of public health It allows governments to provide for exceptions,... (2008) 1 Public Health Ethics 83–8 Article 1 of the Doha Declaration, above n 40 Article 4 of the Doha Declaration, above n 40 Ellen ’t Hoen, The Global Politics of Pharmaceutical Monopoly Power: Drug Patents, Access, Innovation and the Application of the WTO Doha Declaration on TRIPS and Public Health (2009), xvi Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, . blank INCENTIVES FOR GLOBAL PUBLIC HEALTH This portrait of the global debate over patent law and access to essential medicines focuses on public health. Accountability and Governance in a Globalise d World Edited by Jeremy Farrall and Kim Rubenstein INCENTIVES FOR GLOBAL PUBLIC HEALTH Patent Law and Access to