Impact of Trips on the Availability of Medicines in the Developing Countries A Human Right Perspectives

TABLE OF CONTENTS
RESEARCH METHODOLOGY;
1. INTRODUCTION;
I. Context: Discussing the Problem;
II. Rules of Treaty Interpretation (Vienna Convention);
• General Rule of Interpretation;
• Supplementary Means of Interpretation;
III. TRIPs Agreement and Vienna Convention;
• Article 1: Nature and Scope of TRIPs Agreement;
• Article 8: Principles;
• Article 27: Patentable Subject Matter;
• Article 30: Exceptions to Rights Conferred by Patents;
• Article 31: Other Use Without Authorisation of the Right Holder (compulsory Licensing);
• Article 40: Controlling Anti-competitive practices;
IV. Conclusion;
2. BACKDROP: HUMAN RIGHT TO HEALTH AND TRIPS AGREEMENT;
Introduction;
I. Trade-Related Aspects Of Intellectual Property Rights;
II. The Right to Health;
• UDHR;
• ICCPR;
• ICESCR;
• Content of Right to Health;
~ Nature of States' obligations;
~ The Right to the Highest Attainable Standard of Health;
III. Right to Health and Obligation of the State Parties under the Covenant;
IV. South African Experience;
V. Doha Declaration and Public Health;
VI. Conclusion;
3. PHARMACEUTICAL INDUSTRY: HOW IT AFFECTS THE COST OF MEDICINES;
I. Introduction;
II. Patents: An Overview;
III. Possible Options Available within TRIPs Agreement;
1. Compulsory Licensing;
0 Who Can Be issued A Compulsory Licence;
• "Working of the Patents" as a Ground for Compulsory Licensing
• National Emergency as a Ground for Issuing Compulsory Licence;
2. Parallel Imports;
0 Advantages and Disadvantages of Parallel Imports;
3. The Bolar Exemption
0 Origination of the "Bolar Exemption";
0 "Bolar" Exemption under the TRIPs Agreement;
IV. The Pharmaceutical Industry;
I 0 Arguments favouring patents;
0 Superfluous Earnings in the Pharmaceutical Industry;
0 Innovation Deficit in the Pharmaceutical Industry;
V. The Human Rights Responsibilities of Big Pharma;
VI. Conclusion;
4. EXPLOITING VIABLE APPROACHES WITHIN TRIPS FOR HEALTH PURPOSES;
I. Introduction;
Utilizing TRIPs Flexibilities for Public Health Purposes;
II. Constraints on Implementing TRIPs Flexibility in National Laws of Developing Countries;
A. Lack of Technical Expertise to Incorporate and Implement TRIPS Flexibilities in National Law and Policy;
B. Insufficient Domestic Research and Manufacturing Capacities in the Pharmaceutical Sector;
C. Insufficient Technical and Infrastructural Capacities for Medicines Regulation;
D. Difficulties in Establishing Efficient Pharmaceutical Management and Procurement Systems;
E. Bilateral and other TRIPS-plus Pressures;
F. Difficulties in Tackling Anti-Competitive Practices and Abuse of Intellectual Property Rights;
III. Overcoming Constraints;
Relevant Regional Framework;
a. Developing Local Technical Expertise on the Use of TRIPS Flexibilities;
1. FIRST APPROACH: The Andean Community's Approach;
(a) Compulsory licensing;
(b) Parallel imports and exhaustion of rights;
(c) Research and the early working exceptions;
(d) Test data protection;
11. SECOND APPROACH: African Approach;
(a) African Organization for Intellectual Property;
(b) African Regional Intellectual Property Organization;
b. Addressing the Problem of Insufficient Research and Manufacturing Capacities in the Pharmaceutical Sector;
c. Developing Technical and Infrastructural Capabilities for Medicines Regulation;
d. Establishing Efficient Pharmaceutical Management and Procurement Systems;
e. Resisting Bilateral and other TRIPS-plus Pressures;
f. Regional Competition Enforcement Mechanisms;
Conclusion;
5. INDIAN SCENARIO: HEALTH V. NEW PATENT REGIME;
I. Introduction;
II. Health Expenditure in India: The Lowest in the World;
III. New Patent Regime in India: Challenges and Compulsions;
IV. TRIPs Compliant Legislation;
V. Conclusion;
6. CONCLUSION AND SUGGESTIONS;
BIBLIOGRAPHY;
ANNEXURES.