Utilizing TRIPS Flexibilities for Public Health Protection Through South-South Regional Frameworks: I. INTRODUCTION: I.3 Parts of the Study

Utilizing TRIPS Flexibilities for Public Health Protection Through South-South Regional Frameworks
(2004; 110 pages)

Table of Contents

THE SOUTH CENTRE
PREFACE
ABBREVIATIONS
EXECUTIVE SUMMARY
I. INTRODUCTION
	I.1 The Rationale for and Scope of the Study
	I.2 The Study Process and Methodology
	I.3 Parts of the Study
II. INTELLECTUAL PROPERTY AND ACCESS TO ESSENTIAL MEDICINES IN DEVELOPING COUNTRIES
	II.1. An Overview of Public Health-related TRIPS Flexibilities
		II.1.1 Compulsory Licensing
		II.1.2 Parallel Imports and Exhaustion of Rights
		II.1.3 Limitation on the Grant of New Use Pharmaceutical Patents
		II.1.4 Research and the Early Working Exceptions
		II.1.5 Limiting the Extent of Test Data Protection
		II.1.6 Control of Anti-Competitive Practices and Abuse of Intellectual Property Rights
III. CONSTRAINTS ON NATIONAL EFFORTS TO IMPLEMENT TRIPS FLEXIBILITIES FOR PUBLIC HEALTH PURPOSES
	III.1 Lack of Technical Expertise to Incorporate and Implement TRIPS Flexibilities in National Law and Policy
	III.2 Insufficient Domestic Research and Manufacturing Capacities in the Pharmaceutical Sector
	III.3 Insufficient Technical and Infrastructural Capacities for Medicines Regulation
	III.4 Difficulties in Establishing Efficient Pharmaceutical Management and Procurement Systems
	III.5 Bilateral and other TRIPS-plus Pressures
	III.6 Difficulties in Tackling Anti-Competitive Practices and Abuse of Intellectual Property Rights
IV. OVERCOMING CONSTRAINTS IN THE USE OF TRIPS FLEXIBILITIES THROUGH SOUTH-SOUTH REGIONAL FRAMEWORKS
	IV.1 Relevant Regional Frameworks
	IV.2 Regional Approaches to Use of TRIPS flexibilities for Public Health
		IV.2.1 Developing Local Technical Expertise on the Use of TRIPS Flexibilities
		IV.2.2 Addressing the Problem of Insufficient Research and Manufacturing Capacities in the Pharmaceutical Sector
		IV.2.3 Developing Technical and Infrastructural Capabilities for Medicines Regulation
		IV.2.4 Establishing Efficient Pharmaceutical Management and Procurement Systems
		IV.2.5 Resisting Bilateral and other TRIPS-plus Pressures
		IV.2.6 Regional Competition Enforcement Mechanisms
V. CONCLUSIONS AND RECOMMENDATIONS
	V.1 Summary of Recommendations
BIBLIOGRAPHY
BACK COVER

I.3 Parts of the Study

The study is divided into four main parts. The first part provides a brief background on the debate about patents and access to medicines in developing countries as well as an overview of the public health-related TRIPS flexibilities. The second part then identifies the constraints that developing countries face in their efforts to use TRIPS flexibilities for the promotion and protection of public health. The third part analyses, assesses and considers various possibilities for utilizing south-south regional frameworks to overcome the identified constraints in the use of TRIPS flexibilities for public health purposes. Finally, the fourth part draws some conclusions and summarizes the various recommendations made in the study on how developing countries can utilize regional cooperation mechanisms in the South to enhance their capacities to use TRIPS flexibilities for public health promotion and protection.