Impact of TRIPS in India: An Access to Medicines Perspective

Impact of TRIPS in India: An Access to Medicines Perspective

by P. Malhotra

Hardcover(2010)

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Overview

In India today only35 percent ofpeople have access to medicines. This book examines the rise of drug prices in India, anddevelops a new healthcare model, which if implemented, would extend access to medicines to India's entire population. Sensitivity tests show that the proposed model is affordable, equitable and implementable

Product Details

ISBN-13: 9780230272781
Publisher: Palgrave Macmillan UK
Publication date: 10/13/2010
Edition description: 2010
Pages: 320
Product dimensions: 5.70(w) x 8.60(h) x 1.00(d)

About the Author

PRABODH MALHOTRAwas born and brought up in India but has been living in Australia since 1980. Thus, he understands both systems. He has taught at a number of universities in Australia. Prabodh has PhD in Economics and Masters in International Business and has published conference papers, journal articles and government reports in these areas. This book is based on his extensive research and fieldwork in India.

Table of Contents

List of Tables xii

List of Figures xiv

List of Boxes xv

Abbreviations xvi

Foreword xviii

Acknowledgements xx

1 Introduction 1

1.1 Introduction and background 1

1.2 Key issues and key questions 3

1.3 Organisation of the book 5

Part I Influence of Global Forces on Access to Medicines

2 The WTO and the TRIPS Agreement 9

2.1 Introduction 9

2.2 Patents and innovation 11

2.2.1 The case for protection of intellectual property rights 13

2.2.2 The case against protection of intellectual property rights for medicines 16

2.3 The TRIPS agreement 19

2.3.1 The role of TRIPS in the pharmaceutical industry 20

2.3.2 Flexibilities under TRIPS 21

2.3.3 Protection of submitted data 26

2.3.4 Other Articles of importance 28

2.4 Conclusions 30

3 The Global Pharmaceutical Industry and Developing New Drugs 32

3.1 Introduction 32

3.2 The industry structure 33

3.2.1 Pharmaceutical sales, companies, and profits 34

3.2.2 Major pharmaceutical markets, pharmaceutical spending, and generics 37

3.3 Developing new drugs 42

3.3.1 The process of drug development 43

3.3.2 Development time 44

3.3.3 Development costs 46

3.3.4 Direction of pharmaceutical research 51

3.4 Conclusions 52

Part II Access to Medicines in India

4 Development of India's Pharmaceutical Industry 57

4.1 Introduction and background 57

4.2 Growth of the India pharmaceutical industry 58

4.2.1 The significance of the small pharmaceutical firms 59

4.3 Exports and imports 61

4.3.1 TRIPS, India's pharmaceutical exports, and access to medicines 63

4.3.2 Imports 68

4.4 Foreign direct investment 68

4.5 Emerging business models in the pharmaceutical sector 72

4.6 Conclusions 78

5 TRIPS and the Indian Patents Regime 80

5.1 Introduction 80

5.2 Impact of regime change on pharmaceutical industry 81

5.3 The post TRIPS patents regime 85

5.4 Provisions to oppose patents 90

5.4.1 Rising litigations 91

5.5 Uncertainties and ambiguities 99

5.5.1 Access to medicines and the new patent regime 103

5.6 Pharmaceutical innovation 104

5.6.1 The role of government in innovation 108

5.7 Conclusions 109

6 Price Controls and Drug Affordability in India: Policy Options 111

6.1 Introduction 111

6.2 Drug price controls in India 112

6.2.1 DPCO-1995 113

6.2.2 Pre-1970 Price controls 114

6.2.3 DPCO-1970 114

6.2.4 DPCO-1979 115

6.2.5 DPCO-1987 116

6.2.6 DPCO - 2004 (proposed but not yet enacted) 116

6.3 Continuing search for alternatives 117

6.3.1 Trade margins 119

6.4 Market behaviour 120

6.4.1 Price reductions under the voluntary agreement 121

6.4.2 Examining changes to drug prices (2005-08) 123

6.5 Price control models 126

6.6 Conclusions 130

7 Health Insurance in India 131

7.1 Introduction 131

7.2 The Indian approach to health insurance 131

7.2.1 Private health insurance in India 135

7.3 Patient co-payments 137

7.4 Conclusions 140

8 Broadening Access to Medicines and Healthcare in India 141

8.1 Introduction 141

8.2 Providing access to medicines in India 144

8.2.1 Developing the IndiaHealth model 145

8.2.2 The proposed model 146

8.2.3 Implementing the IndiaHealth model 147

8.2.4 Comparing out-of-pocket expenditure 155

8.2.5 Benefits of the proposed model 159

8.2.6 Costing the IndiaHealth programme 161

8.2.7 Funding the IndiaHealth programme 168

8.3 Conclusions 171

Part III Global Perspective

9 Is TRIPS Appropriate for Developing Countries? 175

9.1 Introduction 175

9.2 Patents in developed countries 176

9.2.1 Introduction of pharmaceutical product patents 177

9.3 Costs and benefits of TRIPS 180

9.3.1 Costs and benefits to developing countries 180

9.3.2 Implications for developed countries 183

9.3.3 Further implications for developing countries 184

9.3.4 Recent investigations of protection of pharmaceutical patents 192

9.4 Conclusions 200

10 Which Way Ahead? 201

10.1 Introduction 201

10.2 Alternative models 201

10.2.1 Differential pricing 202

10.2.2 Differential patenting 203

10.2.3 Donating drugs 204

10.2.4 Orphan Drug Act as a model 205

10.2.5 Incremental value based rewards 206

10.2.6 Advance purchase commitments 207

10.2.7 Public-Private Partnerships (PPPs) 207

10.2.8 Open access 208

10.2.9 Health Impact Fund 210

10.2.10 Minimum patenting 211

10.3 Conclusions 212

11 Final Conclusions 214

11.1 Introduction 214

11.2 Answering specific questions 216

11.2.1 How does the regime change impact on India's pharmaceutical exports, particularly exports of the low-cost imitations of patented drugs to the poor countries? 216

11.2.2 What is the effect of TRIPS on foreign direct investment (FDI) into the Indian pharmaceutical industry? 217

11.2.3 How is the business model of domestic firms changing after TRIPS? 218

11.2.4 What impact does the regime change have on the innovative activities within the Indian pharmaceutical industry? 218

11.2.5 How effective have the price controls in India been in providing access to medicines until now and what form of price controls is India likely to have in future? 219

11.2.6 How can India extend access to medicines to its entire population? 220

11.2.7 Is the TRIPS Agreement fair to developing countries? 222

Appendix A 225

Appendix B 238

Appendix C 272

Appendix D 279

Notes 286

References 289

Index 314

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