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系統識別號 U0002-2506200714244000
中文論文名稱 與貿易有關之智慧財產權協定對拉丁美洲國家獲取藥物之影響
英文論文名稱 Trade-Related Aspects of Intellectual Property Rights and Access to Pharmaceuticals in Latin America
校院名稱 淡江大學
系所名稱(中) 拉丁美洲研究所碩士班
系所名稱(英) Graduate Institute of Latin American Studies
學年度 95
學期 2
出版年 96
研究生中文姓名 余仲達
研究生英文姓名 Chung-Dar Yu
學號 694020016
學位類別 碩士
語文別 英文
口試日期 2007-06-15
論文頁數 165頁
口試委員 指導教授-韋淑姍
委員-趙國材
委員-白方濟
中文關鍵字 TRIPS  藥物  FTAs  柔性條款  智慧財產權  愛滋病  世界貿易組織  開發中國家 
英文關鍵字 TRIPS  Pharmaceuticals  FTAs  Flexibilities  Intellectual Property  HIV/AIDS  WTO  Developing Countries 
學科別分類 學科別社會科學區域研究
中文摘要 二十世紀的科技轉變使科學在許多科技領域得到了史無前例的發展。尤其是在醫療以及藥物這兩個領域,治療愛滋病、氣管炎以及瘧疾的藥物和基因研究的新發現都代表著在這兩領域的重大突破。這些戲劇性的進展使開發中國家對於能夠得到妥善治療的願望燃起了新的希望。可是到現在為止對於開發中國家的人民而言事實並非如此,可治療及可預防的疾病每年還是奪取數以百萬人民的生命。如今即使有了在科學以及科技上的重大突破,在世界上還是存在著令人無法接受的不平等待遇,尤其是開發中國家與已開發國家的人民可獲得的醫療品質及水準。

由上述可知,身為開發中地區的拉丁美洲以及加勒比海都面臨著巨大的挑戰。對這些貧窮國家的人民而言獲得非專利的便宜藥物是對於改善他們公共衛生的必要步驟,因此了解開發中國家有什麼應對措施來抵抗藥物產業濫用智慧財產權是非常重要的。本論文的目的是要解釋拉丁美洲與加勒比海地區的國家,使用與貿易有關的智慧財產權協定所賦予的柔性條款,以改善他們國家的公共衛生所碰到的困境。並且在南南體系經濟合作的架構下分析拉丁美洲國家和其他第三世界國家在使用柔性條款時所共同碰到的困難,最後提供了以南南經濟體系地區合作框架來解決此難題的建議。
英文摘要 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.
論文目次 INDEX
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
Reference 112
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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