Impact of TRIPS in India: An Access to Medicines Perspective

337 Pages·2010·2.171 MB·English

by  Prabodh Malhotra (auth.)

Impact of TRIPS in India

Impact of TRIPS in India
An Access to Medicines Perspective
Prabodh Malhotra
©PrabodhMalhotra2010
Foreword©ShovanRay2010
Softcover reprint of the hardcover 1st edition 2010 978-0-230-27278-1
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Malhotra,Prabodh,1951–
ImpactofTRIPSinIndia:anaccesstomedicinesperspective/
PrabodhMalhotra.
p. ; cm.
Includesbibliographicalreferences.
ISBN 978-1-349-32348-7
1. Pharmaceuticalindustry—India. 2. Pharmaceuticalpolicy—India.
3. Healthservicesaccessibility—India. 4. AgreementonTrade-Related
AspectsofIntellectualPropertyRights(1994) I. Title.
[DNLM:1. AgreementonTrade-RelatedAspectsofIntellectualProperty
Rights(1994) 2. DrugIndustry—India. 3. HealthServices
Accessibility—India. 4. InternationalCooperation—India. 5. Patents
asTopic—legislation&jurisprudence—India.QV736]
HD9672.I52M352010
338.4(cid:2)761510954—dc22 2010027535
10 9 8 7 6 5 4 3 2 1
19 18 17 16 15 14 13 12 11 10
Transferred to Digital Printing in 2011
Dedicated to my late parents
Krishna Vati and Sham Lal Malhotra

Contents
ListofTables xii
ListofFigures xiv
ListofBoxes xv
Abbreviations xvi
Foreword xviii
Acknowledgements xx
1 Introduction 1
1.1 Introductionandbackground 1
1.2 Keyissuesandkeyquestions 3
1.3 Organisationofthebook 5
Part I InfluenceofGlobalForcesonAccessto
Medicines
2 TheWTOandtheTRIPSAgreement 9
2.1 Introduction 9
2.2 Patentsandinnovation 11
2.2.1 Thecaseforprotectionofintellectual
propertyrights 13
2.2.2 Thecaseagainstprotectionofintellectual
propertyrightsformedicines 16
2.3 TheTRIPSagreement 19
2.3.1 TheroleofTRIPSinthepharmaceutical
industry 20
2.3.2 FlexibilitiesunderTRIPS 21
2.3.3 Protectionofsubmitteddata 26
2.3.4 OtherArticlesofimportance 28
2.4 Conclusions 30
vii
viii Contents
3 TheGlobalPharmaceuticalIndustryandDeveloping
NewDrugs 32
3.1 Introduction 32
3.2 Theindustrystructure 33
3.2.1 Pharmaceuticalsales,companies,and
profits 34
3.2.2 Majorpharmaceuticalmarkets,
pharmaceuticalspending,andgenerics 37
3.3 Developingnewdrugs 42
3.3.1 Theprocessofdrugdevelopment 43
3.3.2 Developmenttime 44
3.3.3 Developmentcosts 46
3.3.4 Directionofpharmaceuticalresearch 51
3.4 Conclusions 52
Part II AccesstoMedicinesinIndia
4 DevelopmentofIndia’sPharmaceuticalIndustry 57
4.1 Introductionandbackground 57
4.2 GrowthoftheIndiapharmaceuticalindustry 58
4.2.1 Thesignificanceofthesmall
pharmaceuticalfirms 59
4.3 Exportsandimports 61
4.3.1 TRIPS,India’spharmaceuticalexports,and
accesstomedicines 63
4.3.2 Imports 68
4.4 Foreigndirectinvestment 68
4.5 Emergingbusinessmodelsinthepharmaceutical
sector 72
4.6 Conclusions 78
5 TRIPSandtheIndianPatentsRegime 80
5.1 Introduction 80
5.2 Impactofregimechangeonpharmaceutical
industry 81
5.3 ThepostTRIPSpatentsregime 85
5.4 Provisionstoopposepatents 90
5.4.1 Risinglitigations 91
5.5 Uncertaintiesandambiguities 99
5.5.1 Accesstomedicinesandthenewpatent
regime 103
Contents ix
5.6 Pharmaceuticalinnovation 104
5.6.1 Theroleofgovernmentininnovation 108
5.7 Conclusions 109
6 PriceControlsandDrugAffordabilityinIndia:Policy
Options 111
6.1 Introduction 111
6.2 DrugpricecontrolsinIndia 112
6.2.1 DPCO–1995 113
6.2.2 Pre-1970Pricecontrols 114
6.2.3 DPCO–1970 114
6.2.4 DPCO–1979 115
6.2.5 DPCO–1987 116
6.2.6 DPCO–2004(proposedbutnotyet
enacted) 116
6.3 Continuingsearchforalternatives 117
6.3.1 Trademargins 119
6.4 Marketbehaviour 120
6.4.1 Pricereductionsunderthevoluntary
agreement 121
6.4.2 Examiningchangestodrugprices
(2005–08) 123
6.5 Pricecontrolmodels 126
6.6 Conclusions 130
7 HealthInsuranceinIndia 131
7.1 Introduction 131
7.2 TheIndianapproachtohealthinsurance 131
7.2.1 PrivatehealthinsuranceinIndia 135
7.3 Patientco-payments 137
7.4 Conclusions 140
8 BroadeningAccesstoMedicinesandHealthcare
inIndia 141
8.1 Introduction 141
8.2 ProvidingaccesstomedicinesinIndia 144
8.2.1 DevelopingtheIndiaHealthmodel 145
8.2.2 Theproposedmodel 146
8.2.3 ImplementingtheIndiaHealthmodel 147
8.2.4 Comparingout-of-pocketexpenditure 155
8.2.5 Benefitsoftheproposedmodel 159