INCENTIVES FOR GLOBAL PUBLIC HEALTH Thisportraitoftheglobaldebateoverpatentlawandaccesstoessential medicinesfocusesonpublichealthconcernsaboutHIV/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 Organization, the World HealthOrganizationandtheWorldIntellectualPropertyOrganization. Drawinguponinternationaltradelaw,innovationpolicy,intellectual property law, health law, human rights and philosophy, the authors seektocanvasspolicysolutionsthatencourageandrewardworthwhile pharmaceuticalinnovationwhileensuringaffordableaccesstoadvanced medicines. A number of creative policy options are critically assessed, includingthedevelopmentofaHealthImpactFund,prizesformedical innovation,theuseofpatentpools,OpenSourcedrugdevelopmentand formsof‘creativecapitalism’. thomas pogge isLeitnerProfessor ofPhilosophyandInternational Affairs at Yale University, Professorial Fellow at the ANU Centre for AppliedPhilosophyandPublicEthics(CAPPE),ResearchDirectoratthe Oslo University Centre for the Study of Mind in Nature (CSMN) and AdjunctProfessorattheUniversityofCentralLancashire. matthew rimmer is a senior lecturer and Associate Director of Research at the ANU College of Law, and Associate Director of the AustralianCentreforIntellectualPropertyinAgriculture. kim rubenstein is Professor and Director of the Centre for International and Public Law (CIPL) at the ANU College of Law, AustralianNationalUniversity. CONNECTING INTERNATIONAL LAW WITH PUBLIC LAW This series of books flows from workshops bringing public and international lawyers and public and international policy makers togetherforinterdisciplinarydiscussiononselectedtopicsandthemes. Itaimstobroadenbothpublicandinternationallaws’understandingof how these two areas intersect. Until now, international and public law have mainly overlapped in discussions on how international law is implementeddomestically.Thisseriesisuniqueinconsciouslybringing togetherpublicandinternationallawyerstoconsiderandengageineach other’sscholarship. SeriesEditors ProfessorKimRubenstein,AustralianNationalUniversity ProfessorThomasPogge,YaleUniversity Booksintheseries IncentivesforGlobalPublicHealth:PatentLawandAccesstoEssential Medicines EditedbyThomasPogge,MatthewRimmerandKimRubenstein Sanctions,AccountabilityandGovernanceinaGlobalisedWorld EditedbyJeremyFarrallandKimRubenstein 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,NewYork,Melbourne,Madrid,CapeTown,Singapore, SãoPaulo,Delhi,Dubai,Tokyo CambridgeUniversityPress TheEdinburghBuilding,CambridgeCB28RU,UK PublishedintheUnitedStatesofAmericabyCambridgeUniversityPress,NewYork www.cambridge.org Informationonthistitle:www.cambridge.org/9780521116565 ©CambridgeUniversityPress2010 Thispublicationisincopyright.Subjecttostatutoryexception andtotheprovisionsofrelevantcollectivelicensingagreements, noreproductionofanypartmaytakeplacewithoutthewritten permissionofCambridgeUniversityPress. Firstpublished2010 PrintedintheUnitedKingdomattheUniversityPress,Cambridge AcataloguerecordforthispublicationisavailablefromtheBritishLibrary LibraryofCongressCataloguinginPublicationdata Incentivesforglobalpublichealth:patentlawandaccesstoessentialmedicines/editedby ThomasPogge,MatthewRimmer,andKimRubenstein. p. cm.–(Connectinginternationallawwithpubliclaw) Includesbibliographicalreferences. ISBN978-0-521-11656-5(hardback) 1. Pharmaceuticalpolicy. 2. Patentlawsandlegislation 3. Drugs–Patents. 4. Patents (Internationallaw) I. Pogge,ThomasWinfriedMenko. II. Rimmer, Matthew. III. Rubenstein,Kim. IV. Title. V. Series: Connectinginternationallawwithpubliclaw. [DNLM: 1. Legislation,Drug–organization&administration. 2. Drugs,Essential–supply &distribution. 3. HealthServicesAccessibility–legislation&jurisprudence. 4. Human Rights. 5. InternationalCooperation. 6. PatentsasTopic–legislation&jurisprudence. QV33.1I36 2010] RA401.A1I43 2010 362.17082–dc22 2010010211 ISBN978-0-521-11656-5Hardback CambridgeUniversityPresshasnoresponsibilityforthepersistenceor accuracyofURLsforexternalorthird-partyInternetwebsitesreferredtoin thispublication,anddoesnotguaranteethatanycontentonsuchwebsitesis, orwillremain,accurateorappropriate. CONTENTS Contributors viii SeriesEditors’Preface xvii Editors’Preface xix Introduction:Accesstoessentialmedicines:publichealthand internationallaw 1 thomas pogge, matthew rimmer and kim rubenstein PART I Internationaltrade 33 1. TRIPSandessentialmedicines:mustonesizefitall?Makingthe WTOresponsivetotheglobalhealthcrisis 35 rochelle c. dreyfuss 2. TheTRIPSWaiverasarecognitionofpublichealthconcernsin theWTO 56 andrew d. mitchell and tania voon 3. Publiclawchallengestotheregulationofpharmaceutical patentsintheUSbilateralfreetradeagreements 77 hitoshi nasu 4. Globalhealthanddevelopment:patentsandpublic interest 101 elizabeth siew-kuan ng v vi contents PART II Innovation 133 5. TheHealthImpactFund:betterpharmaceuticalinnovations atmuchlowerprices 135 thomas pogge 6. TheHealthImpactFund:acritique 155 kathleen liddell 7. Aprizesystemasapartialsolutiontothehealthcrisisinthe developingworld 181 william w. fisher and talha syed 8. Innovationandinsufficientevidence:thecasefora WTO–WHOAgreementonHealthTechnologySafetyand Cost-EffectivenessEvaluation 209 thomas faunce PART III Intellectualproperty 233 9. Openingthedam:patentpools,innovationandaccess toessentialmedicines 235 dianne nicol and jane nielsen 10. OpenSourcedrugdiscovery:arevolutionaryparadigm oraUtopianmodel? 263 krishna ravi srinivas 11. Accessingandbenefitsharingavianinfluenzaviruses throughtheWorldHealthOrganization:aCBD andTRIPScompromisethankstoIndonesia’s sovereigntyclaim? 284 charles lawson and barbara ann hocking 12. TheLazarusEffect:the(RED)Campaignandcreative capitalism 313 matthew rimmer PART IV Healthcare 341 13. BeyondTRIPS:theroleofnon-stateactorsandaccess toessentialmedicines 343 noah benjamin novogrodsky contents vii 14. Securinghealththroughrights 357 katharine g. young 15. Theroleofnationallawsinreconcilingconstitutionalrightto healthwithTRIPSobligations:anexaminationoftheGlivec patentcaseinIndia 381 rajshree chandra 16. Tippingpoint:Thaicompulsorylicencesredefineessential medicinesdebate 406 jonathan burton-macleod Bibliography 425 Index 486 CONTRIBUTORS Editors Having received his PhD in philosophy from Harvard University, PROFESSOR THOMAS POGGE is Leitner Professor of Philosophy and InternationalAffairsatYaleUniversity,ProfessorialFellowattheANU Centre for Applied Philosophy and Public Ethics (CAPPE), Research Director at the Oslo University Centre for the Study of Mind in Nature (CSMN)andAdjunctProfessorattheUniversityofCentralLancashire. 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 pharmaceutical patentregimethatwouldimproveaccesstoadvancedmedicinesforthe poor worldwide. His recent publications include World Poverty and Human Rights, 2nd edn. 2008; Global Justice and Global Ethics, both 2008; and John Rawls: His Life and Theory of Justice and Freedom from PovertyasaHumanRight,both2007. dr matthew rimmer is a senior lecturer and Associate Director 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)andaUniversityMedalinliterature,andanLLB(Hons)from the Australian 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 Digital Allliance. Dr Rimmer is the author of Digital Copyright and the Consumer Revolution: Hands off my iPod (2007) and Intellectual Property and Biotechnology: Biological Inventions (2008). He edited the viii contributors ix collectionPatentLawandBiologicalInventions(2006).DrRimmerwas a chief investigator in an ARC Discovery Project, ‘Gene Patents in Australia: Options for Reform’ (2003–5), and an ARC Linkage Grant, ‘TheProtectionofBotanicalInventions’(2003).Hehaspublishedwidely on copyright law and information technology, patent law and biotechnology, access to medicines, clean technologies and traditional knowledge. professor kim rubenstein isProfessorandDirectoroftheCentre for International and Public Law (CIPL) at the ANU College of Law, Australian National University. A graduate of the University of Melbourne and Harvard University, Professor Rubenstein’s current research projects are at the cutting edge of the intersection between public and international law. Her public law work spans constitutional andadministrativelaw,andalsoincludesherexpertiseincitizenshiplaw. Her international law work focuses on the status of nationality. Her book, Australian Citizenship Law in Context (2002) represents the foundation of her continued scholarly work, looking at the disjuncture between the exclusive legal notion and the more inclusive normative understandingofcitizenship. OtherContributors jonathan burton-macleod holdsaBScfromHarvardUniversity, alawdegreefromQueen’sUniversity,Canada,andaMastersinLawfrom Harvard Law School. Burton-MacLeod’s initial focus was biochemistry andheworkedattheCentersforDiseaseControl,Atlanta.Inlawschool, his focus remained on international health, with study conducted at the University of Cape Town Faculty of Law. His graduate law degree focused on theories of law and society in the globalization of law, viewed through the lens of public health. Since finishing, much of Burton-MacLeod’s research has focused on American and comparative Constitutional law. He was a lecturer at the ANU College of Law. Burton-MacLeod is currently an Assistant Professor and Assistant Dean (Research) at Jindal Global Law School and Assistant Director at theCentreforGlobalGovernanceandPolicy. rajshree chandra is a Senior Lecturer at Janki Devi Memorial College, Delhi University with fifteen years’ teaching experience in the