Impact of TRIPS in India: An Access to Medicines Perspective

Cover......Page 1
Contents......Page 8
List of Tables......Page 13
List of Figures......Page 15
List of Boxes......Page 16
Abbreviations......Page 17
Foreword......Page 19
Acknowledgements......Page 21
1.1 Introduction and background......Page 24
1.2 Key issues and key questions......Page 26
1.3 Organisation of the book......Page 28
Part I: Influence of Global Forces on Access to Medicines......Page 30
2.1 Introduction......Page 32
2.2 Patents and innovation......Page 34
2.2.1 The case for protection of intellectual property rights......Page 36
2.2.2 The case against protection of intellectual property rights for medicines......Page 39
2.3 The TRIPS agreement......Page 42
2.3.1 The role of TRIPS in the pharmaceutical industry......Page 43
2.3.2 Flexibilities under TRIPS......Page 44
2.3.3 Protection of submitted data......Page 49
2.3.4 Other Articles of importance......Page 51
2.4 Conclusions......Page 53
3.1 Introduction......Page 55
3.2 The industry structure......Page 56
3.2.1 Pharmaceutical sales, companies, and profits......Page 57
3.2.2 Major pharmaceutical markets, pharmaceutical spending, and generics......Page 60
3.3 Developing new drugs......Page 65
3.3.1 The process of drug development......Page 66
3.3.2 Development time......Page 67
3.3.3 Development costs......Page 69
3.3.4 Direction of pharmaceutical research......Page 74
3.4 Conclusions......Page 75
Part II Access to Medicines in India......Page 78
4.1 Introduction and background......Page 80
4.2 Growth of the India pharmaceutical industry......Page 81
4.2.1 The significance of the small pharmaceutical firms......Page 82
4.3 Exports and imports......Page 84
4.3.1 TRIPS, India’s pharmaceutical exports, and access to medicines......Page 86
4.4 Foreign direct investment......Page 91
4.5 Emerging business models in the pharmaceutical sector......Page 95
4.6 Conclusions......Page 101
5.1 Introduction......Page 103
5.2 Impact of regime change on pharmaceutical industry......Page 104
5.3 The post TRIPS patents regime......Page 108
5.4 Provisions to oppose patents......Page 113
5.4.1 Rising litigations......Page 114
5.5 Uncertainties and ambiguities......Page 122
5.5.1 Access to medicines and the new patent regime......Page 126
5.6 Pharmaceutical innovation......Page 127
5.6.1 The role of government in innovation......Page 131
5.7 Conclusions......Page 132
6.1 Introduction......Page 134
6.2 Drug price controls in India......Page 135
6.2.1 DPCO – 1995......Page 136
6.2.3 DPCO – 1970......Page 137
6.2.4 DPCO – 1979......Page 138
6.2.6 DPCO – 2004 (proposed but not yet enacted)......Page 139
6.3 Continuing search for alternatives......Page 140
6.3.1 Trade margins......Page 142
6.4 Market behaviour......Page 143
6.4.1 Price reductions under the voluntary agreement......Page 144
6.4.2 Examining changes to drug prices (2005–08)......Page 146
6.5 Price control models......Page 149
6.6 Conclusions......Page 153
7.2 The Indian approach to health insurance......Page 154
7.2.1 Private health insurance in India......Page 158
7.3 Patient co-payments......Page 160
7.4 Conclusions......Page 163
8.1 Introduction......Page 164
8.2 Providing access to medicines in India......Page 167
8.2.1 Developing the IndiaHealth model......Page 168
8.2.2 The proposed model......Page 169
8.2.3 Implementing the IndiaHealth model......Page 170
8.2.4 Comparing out-of-pocket expenditure......Page 178
8.2.5 Benefits of the proposed model......Page 182
8.2.6 Costing the IndiaHealth programme......Page 184
8.2.7 Funding the IndiaHealth programme......Page 191
8.3 Conclusions......Page 194
Part III: Global Perspective......Page 196
9.1 Introduction......Page 198
9.2 Patents in developed countries......Page 199
9.2.1 Introduction of pharmaceutical product patents......Page 200
9.3.1 Costs and benefits to developing countries......Page 203
9.3.2 Implications for developed countries......Page 206
9.3.3 Further implications for developing countries......Page 207
9.3.4 Recent investigations of protection of pharmaceutical patents......Page 215
9.4 Conclusions......Page 223
10.2 Alternative models......Page 224
10.2.1 Differential pricing......Page 225
10.2.2 Differential patenting......Page 226
10.2.3 Donating drugs......Page 227
10.2.4 Orphan Drug Act as a model......Page 228
10.2.5 Incremental value based rewards......Page 229
10.2.7 Public–Private Partnerships (PPPs)......Page 230
10.2.8 Open access......Page 231
10.2.9 Health Impact Fund......Page 233
10.2.10 Minimum patenting......Page 234
10.3 Conclusions......Page 235
11.1 Introduction......Page 237
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?......Page 239
11.2.2 What is the effect of TRIPS on foreign direct investment (FDI) into the Indian pharmaceutical industry?......Page 240
11.2.4 What impact does the regime change have on the innovative activities within the Indian pharmaceutical industry?......Page 241
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?......Page 242
11.2.6 How can India extend access to medicines to its entire population?......Page 243
11.2.7 Is the TRIPS Agreement fair to developing countries?......Page 245
Appendix A......Page 248
Appendix B......Page 261
Appendix C......Page 295
Appendix D......Page 302
Notes......Page 309
References......Page 312
Index......Page 337