||Trade-Related Aspects of Intellectual Property Rights and Access to Pharmaceuticals in Latin America
||Graduate Institute of Latin American Studies
|| The technological transformation of the 20th Century had the effect of advancing the frontiers of science in many technological fields. In the medical and pharmaceutical field, in particular, major technological breakthroughs have been witnessed including the mapping of the human genome, antiretroviral (ARV) therapy for the treatment of HIV/AIDS and the second line treatments for tuberculosis and malaria. These dramatic developments have provided increasing hope for the realization of the right to health in the developing world. For the people in these regions, however, the reality on the ground is the opposite; treatable and preventable diseases continue to kill millions a year.
Today, despite significant scientific and technological developments, there continue to exist unacceptable inequalities in the health status of people between developed and developing countries as well as within developing countries. In this context, Latin America and the Caribbean, being a part of the developing world is also facing great challenges. Access to essential medicines is critical in this part of the world, it is important to understand what is being done to resist intellectual property rights abuse in the pharmaceutical sector. The objective of this study is to explain the obstacles Latin America and the Caribbean are facing in using the flexibilities inherent in TRIPS to seek access of medicines for their citizens, and also suggest some recommendations on how to overcome these obstacles through a south to south regional framework.
I. Introduction 1
I.1 Motive and Objective of Study 2
I.2 Methodology and Materials 3
I.3 Parts of Study 4
II. TRIPS and the New Regime of Intellectual Property 5
II.1 The United States as a Formulator of Regulations 6
II.2 TRIPS and Multilateral Trade Agreements 8
II.3 Free Trade Agreements and Autonomy 11
II.4 Intellectual Property Development and Flexibilities Inherent in TRIPS 12
II.4.1 Public Health Related TRIPS Flexibilities 14
II.4.2 Compulsory Licensing 15
II.4.3 Parallel Importing and Exhaustion of Rights 16
II.4.4 Limitation on the Grant of New Use Pharmaceutical Patents 16
II.4.5 Research and the Early Working Exceptions 18
II.4.6 Limiting the Extent of Test Data Protection 19
II.4.7 Control of Anti-Competitive Practices and Abuse of Intellectual Property Rights 20
III. Developments in the Debate on Access to Drugs and Intellectual Property 23
III.1 The Case in Argentina 23
III.2 United States versus South Africa 28
III.3 United States versus Brazil 34
III.4 The 1999 Seattle World Trade Organization Ministerial 35
III.5 Changing Attitudes among Global Players 37
III.5.1 The World Health Organization 37
III.5.2 The European Union 38
III.5.3 Other Organizations 38
III.6 The Doha Public Health Declaration in November 2001 39
III.6.1 Background 39
III.6.2 The African proposal for a special TRIPS Council in June 2001 40
III.6.3 Negotiations in Doha 42
III.6.4 Why was the negotiation process so successful for developing countries? 45
III.6.5 Drug industry response to the WTO Declaration on TRIPS and Public Health 45
III.7 Post Doha Public Health Declaration 47
III.7.1 U.S. Policy after the Doha Public Health Declaration 47
III.7.2 The Case in Guatemala 50
III.7.3 U.S. Policy Continues to Support It’s Pharmaceutical Industry 54
III.7.4 Production and Export of Medicines, Is the Doha Spirit Disappearing? 55
IV. Constraints on National Efforts to Implement TRIPS Flexibilities for Public Health Purposes 59
IV.1 Lack of Technical Expertise to Incorporate and Implement TRIPS flexibilities in National Law and Policy 59
IV.2 Insufficient Domestic Research and Manufacturing Capacities in the Pharmaceutical Sector 61
IV.3 Insufficient Technical and Infrastructural Capacities for Medicines Regulation 63
IV.4 Difficulties in Establishing Efficient Pharmaceutical Management and Procurement Systems 64
IV.5 Bilateral and other TRIPS-plus pressures 64
IV.6 Difficulties in Tackling Anti-Competitive Practices and Abuse of Intellectual Property Rights 66
V. Overcoming Obstacles in the Use of TRIPS Flexibilities for Public Health Purposes through South-South Regional Frameworks 68
V.1 Relevant Regional Frameworks 68
V.2 Regional Approaches to the Use of TRIPS Flexibilities for Public Health 79
V.2.1 Developing Local Technical Expertise on the Use of TRIPS Flexibilities 80
V.2.2 Addressing the Problem of Insufficient Research and Manufacturing Capacities in the Pharmaceutical Sector 87
V.2.3 Developing Technical and Infrastructural Capabilities for Medicine Regulation 92
V.2.4 Establishing Efficient Pharmaceutical Management and Procurement Systems 95
V.2.5 Resisting Bilateral and other TRIPS-plus Pressures 99
V.2.6 Regional Competition Enforcement Mechanisms 101
VI. Conclusions 103
Annex 1: Declaration on the TRIPS Agreement and Public Health 127
Annex 2: Agreement on Trade-Related Aspects of Intellectual Property Rights 129
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