Balancing wealth and health : the battle over intellectual property and access to medicines in Latin America

369 Pages·2014·1.7 MB·English

by  Dreyfuss, Rochelle Cooper, Rodriguez-Garavito, Cesar

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
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EditedbyKevinE.Davis,AngelinaFisher,BenedictKingsbury,
andSallyEngleMerry
TheDesignofCompetitionLawInstitutions
GlobalNorms,LocalChoices
EditedbyEleanorM.FoxandMichaelJ.Trebilcock
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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
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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