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BALANCING WEALTH AND HEALTH LAW AND GLOBAL GOVERNANCE SERIES Editors: AndrewHurrell,BenedictKingsbury,andRichardB.Stewart Global governance involves the exercise of power, beyond a single state, to influence behaviour, to generate resources, or to allocate authority. Regulatory structures, and law ofallkinds,increasinglyshapethenature,use,andeffectsofsuchpower.Thesedynamic processesoforderingandgovernanceblendtheextra-nationalwiththenational,thepublic with the private, the political and economic with the social and cultural. Issues of effect- iveness, justice, voice, and inequality in these processes are growing in importance. This seriesfeaturesexceptionalworksoforiginalresearchandtheory—bothsector-specificand conceptual—thatcarryforwardtheseriousunderstandingandevaluationoftheseprocesses ofglobalgovernanceandtheroleoflawandinstitutionswithinthem.Contributionsfrom alldisciplinesarewelcomed.Theseriesaimsespeciallytodeepenscholarshipandthinking in international law, international politics, comparative law and politics, and public and private global regulation. A major goal is to study governance globally, and to enrich the literatureonlawandthenatureandeffectsofglobalgovernancebeyondtheNorthAtlantic region. alsoavailableintheseries GovernancebyIndicators GlobalPowerthroughQuantificationandRankings EditedbyKevinE.Davis,AngelinaFisher,BenedictKingsbury, andSallyEngleMerry TheDesignofCompetitionLawInstitutions GlobalNorms,LocalChoices EditedbyEleanorM.FoxandMichaelJ.Trebilcock TheRiseoftheRegulatoryStateoftheSouth InfrastructureandDevelopmentinEmergingEconomies EditedbyNavrozK.DubashandBronwenMorgan Balancing Wealth and Health The Battle over Intellectual Property and Access to Medicines in Latin America Editedby ROCHELLE C. DREYFUSS and CÉSAR RODRÍGUEZ-GARAVITO 1 3 GreatClarendonStreet,Oxford,OX26DP, UnitedKingdom OxfordUniversityPressisadepartmentoftheUniversityofOxford. ItfurtherstheUniversity’sobjectiveofexcellenceinresearch,scholarship, andeducationbypublishingworldwide.Oxfordisaregisteredtrademarkof OxfordUniversityPressintheUKandincertainothercountries ©Theseveralcontributors2014 Themoralrightsoftheauthorshavebeenasserted FirstEditionpublishedin2014 Impression:1 Allrightsreserved.Nopartofthispublicationmaybereproduced,storedin aretrievalsystem,ortransmitted,inanyformorbyanymeans,withoutthe priorpermissioninwritingofOxfordUniversityPress,orasexpresslypermitted bylaw,bylicenceorundertermsagreedwiththeappropriatereprographics rightsorganization.Enquiriesconcerningreproductionoutsidethescopeofthe aboveshouldbesenttotheRightsDepartment,OxfordUniversityPress,atthe addressabove Youmustnotcirculatethisworkinanyotherform andyoumustimposethissameconditiononanyacquirer CrowncopyrightmaterialisreproducedunderClassLicence NumberC01P0000148withthepermissionofOPSI andtheQueen’sPrinterforScotland PublishedintheUnitedStatesofAmericabyOxfordUniversityPress 198MadisonAvenue,NewYork,NY10016,UnitedStatesofAmerica BritishLibraryCataloguinginPublicationData Dataavailable LibraryofCongressControlNumber:2013956285 ISBN 978–0–19–967674–3 PrintedandboundinGreatBritainby CPIGroup(UK)Ltd,Croydon,CR04YY LinkstothirdpartywebsitesareprovidedbyOxfordingoodfaithand forinformationonly.Oxforddisclaimsanyresponsibilityforthematerials containedinanythirdpartywebsitereferencedinthiswork. Foreword In most critical iconographies of iniquities of contemporary global regulatory governance, a prominent place is accorded to the complex regime of intellectual property law anditseffectson universalaffordable access to,anddevelopmentof, essential medicines. The rules and supervisory institutions of the Trade-Related aspects of Intellectual Property Agreement of 1994 (TRIPS), and the various “TRIPS plus” rules in a congeries of different bilateral and regional or plurilateral agreementsincludingtheCentral AmericanFreeTradeAgreement(CAFTA),the Anti-Counterfeiting Trade Agreement (ACTA) and the draft Trans-Pacific Part- nership agreement (TPP), are explained in a familiar political account. In that narrative,thepowerfulgovernmentsoftheNorth,themselveshighlyresponsiveto their major innovation creative industries including pharmaceutical companies, have by dividing and dragooning brought developing country governments to make agreements which increase local prices of pharmaceutical products without incentivizinglocalproductioncapacityorinvestmentincombattingmajordiseases other than those occurring in rich countries. The case studies and analysis in this highly original and indeed pathbreaking book do not so much challenge as look behind this overarching narrative to document, within a common conceptual framework, a highly variegated experience among eleven Latin American democ- racies with similar overall trajectories of movement from essentially no patent protection of pharmaceutical products in the 1980s to becoming, over the next two decades, compliant with TRIPS or TRIPS plus. These countries have varied notonlyinwhattheyhavesoughtandbeenabletoachieveinrelevantinternational negotiationsandinstitutions,butalsoinveryspecificbutsignificantfeaturesofthe implementation and application of international rules in their national law and institutions(suchaspatentoffices)allowingforgreaterorlesseraccesstomedicines. As thecountrystudies show,pro-access national intellectual property practices do notnecessarilycorrelatewithlowerprices,letalonebetterhealthoutcomes—much more is involved in achieving health improvements—but the variations and the explanatoryfactorspresentedintherichandfine-grainedstudiesbythecontribu- torsareofgreatinterestandimportance. ThestudyofGlobalAdministrativeLaw(GAL)istheinvestigationofquotidian governance—how power works in practice on a daily basis—and in particular of how specific legal-procedural features channel, magnify and check that power. Necessarilyitmustbeconcernedwithallelementsofglobalregulatorygovernance: theconstitutiverulesanddesignfeaturesofinternationalandnationalinstitutions, their substantive output, the procedural rules and practices and mechanisms by which they operate, the intricate relations between (formal and informal) institu- tions, and the resulting dynamics of winner and losers, justice and injustice over time within the global administrative space. Adherence to GAL norms of good vi Foreword processcanhelpsecuresupportforglobalanddomesticgovernanceregimesinways which differ from legitimation based on state delegation, human rights consider- ations,orqualityofoutputs.ThereasonsforadoptionofGALnormsarediverse. For instance, “baptist and bootlegger” coalitions of business and NGO interests mayinsomecasesuniteontheimportanceoftransparencywhiledivergingsharply on fundamental goals and policies. This is one element of an explanation for the rapidity ofuptake of GAL procedures in diverse fields of global governance. GAL procedures and mechanisms may often align with the overall interests of the powerful within a neo-liberal agenda. Yet democratic governments have sought to evade some such controls in pursuing that agenda, for example in choosing to conduct ACTA and TPP negotiations in almost complete secrecy from wider publics.Overall,therelationsbetweenproceduralarrangements—fortransparency, noticeandcomment,participation,reason-giving,review,andoverallaccountabil- ity—and substantive justice in global regulatory governance are underresearched, undertheorized,andpoorlyunderstood.Illuminatingtheserelations,inthespecific contextofintellectualpropertyandpharmaceuticalsinLatinAmerica,isoneofthe majorgeneralcontributionsofthisvolume. Takingasitscriterionofsubstantivejusticetheachievementofaffordableaccess tomedicines,againstastipulatedbackgroundofcontinuinglarge-scalepovertyand intensivepressurefromtheNorthAtlanticgovernmentsforadoptionofverystrong intellectualpropertyprotectionforpharmaceuticals,thebookviewsthepursuitof substantive justice largely in terms of counter-power: resistance and contestation. This counter-power is evaluated by the case studies in relation to two domains which we suggest may usefully be distinguished. The first domain is that of standard law-making: international treaty negotiation or making of ensuing national legislation. In this domain contestation and resistance vary (subject to basicstructuralconstraintsincludingdegreesofpowerasymmetryordependence) with levels ofaccess-related expertise available, involvementof national and extra- national civil society advocacy organizations, and dynamics in the political econ- omyoftheparticulardevelopingcountry(e.g.astronggenericsindustry).Thekey links posited between the political economy of decision-making in these domains and GAL procedural elements is through the organizing variables of international and national political opportunity structures; further examination of the link betweenGALprocessesandtheopennessofopportunitystructuresisapromising area for further research. The second domain is the sub-treaty and sub-legislative operationalization of the legal regime of intellectual property and access to medi- cines. Within each developing country, national pharmaceutical regulatory or procurement and oversight agencies, patent offices, courts, and constitutional litigation institutions play notable roles in different case studies, as do regional juridical bodies such as the Andean Court of Justice and (potentially) the Inter- AmericanCommissionandCourtofHumanRights,andglobalentitiessuchasthe WorldTradeOrganization’sDisputeSettlementBody,alongwiththeconceptual and interpretive resources provided by rival regimes such as that of the constitu- tionalorinternationallawrighttohealth.Inthissecond,administrativedomainthe insights on process-substance-justice relations in the case studies in this volume Foreword vii interlock with other work of the Global Administrative Network, including the immediatelyprecedingvolumesintheLawandGlobalGovernanceseriestowhich the present book is a welcome addition. The research strategy, concepts, and methodologies developed in this book repay careful consideration not only for fruitful deployment to examine dynamics of health and intellectual property in other regions, but also for generating innovative insights in other fields of global regulatorygovernance. BenedictKingsbury RichardB.Stewart Acknowledgements We are grateful to the International Development Research Centre (IDRC) for providing financial support to this research project and to NYU’s Global Admin- istrativeLawProjectandtheUniversityoflosAndes’ProgramonGlobalJusticefor encouraging our efforts. We thank the Engelberg Center on Innovation Law and Policy for sponsoring a workshop that allowed the individual research groups to exchangeideasandpresenttheirfindingstocommentators.Thateventcontributed significantlytothequalityofthefinalproduct.WealsothanktheCenterforLaw, JusticeandSociety(Dejusticia)andtheFordFoundationforsponsoringexchanges amongthecountrycasestudyauthors.JoseAcosta(NYUJDClassof2014),Maria Etchegorry (NYU LLM Class of 2011), Anthony R. Enriquez (NYU JD Class of 2013),andCeleste Kauffman (Dejusticia)provided invaluablelegal andlinguistic assistance compiling information and editing texts. We appreciate the efforts of ShayonGhoshandAndrewMoore(NYUClassof2015),whodidallthethankless, last-minute tasks of nailing down citations and factual information. The Filomen D’Agostino and Max E. Greenberg Research Fund provided financial support for Rochelle Dreyfuss’s contributions. The Ford Foundation provided financial sup- portforCésarRodríguez-Garavito’scontributions. WithoutthesuperborganizationalcapabilitiesofNicoleArzt(NYU)andCamila Soto(UniversityoflosAndes),thisvolumewouldnothavebeenpossible. RochelleCooperDreyfuss CésarRodríguez-Garavito Table of Contents ListofContributors xiii 1. TheBattleoverIntellectualPropertyLawsandAccesstoMedicines inLatinAmerica:APrimeronGlobalAdministrativeLaw, IntellectualProperty,andPoliticalContestation 1 RochelleCooperDreyfussandCésarRodríguez-Garavito I. GlobalAdministrativeLaw:PotentialandChallenges 4 II. ContestingTransnationalRegulation:ThePoliticalField 7 III. IntellectualPropertyasaSiteofTransnationalRegulationand Contestation 9 IV. HistoricalBackgroundoftheRegion:Neoliberalism, Neoconstitutionalism,andInstitutionalReform(1990–2010) 19 V. OverviewoftheBook:StudyingIntellectualPropertyandAccess toMedicinesinLatinAmerica.BackgroundandMethods 22 PART I COUNTRY STUDIES 2. TheRecursivityofGlobalLawmakingintheStrugglefor anArgentinePolicyonPharmaceuticalPatents 37 PaolaBergalloandAgustinaRamónMichel I. RecursivityintheReformoftheArgentineIPRegime 41 II. Background:TheArgentinePharmaceuticalIndustryandMarket 43 III. TheFirstPhaseoftheDomesticCycle,1989–1995 46 IV. ThePoliticsofDomesticEnactment:ActorsandMechanisms 57 V. ThePoliticsofImplementation,1996–2002 63 VI. TheNewIPLegislationattheDisputeSettlementBodyInterface 70 VII. ImplementationContinues:GlobalReframingandthe DomesticCrisis,2002–2010 71 VIII. BalancingPatentandHealthRights 77 3. BrazilandtheCaseofPatentsandAccesstoMedicines: AMedicalCondition? 89 MônicaSteffenGuiseRosinaandAdelinadeOliveiraNovaes I. FulfillingtheConstitutionalRighttoHealth:TheCaseof AccesstoMedicines 93 II. MainActorsandEventsContributingtotheCurrentLegal ApproachtoPatentsandAccesstoMedicinesinBrazil 97 III. Conclusion 107

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