Utilizing TRIPS Flexibilities for Public Health Protection Through South-South Regional Frameworks: II. INTELLECTUAL PROPERTY AND ACCESS TO ESSENTIAL MEDICINES IN DEVELOPING COUNTRIES: II.1. An Overview of Public Health-related TRIPS Flexibilities

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

II.1. An Overview of Public Health-related TRIPS Flexibilities

The adoption of the TRIPS minimum standards resulted into a significant loss of policy flexibilities by developing countries in regulating the granting and use of pharmaceutical patents and controlling the cost of medicines. However, the Agreement left some room for countries to take public interest measures including measures to protect public health. The Doha Declaration recognized that the TRIPS Agreement does not prevent Members from taking measures to protect public health. At Doha, WTO Members also reaffirmed the right of each Member to use to the full, the provisions of the Agreement which provide flexibility for protecting public health and, in particular, for promoting access to medicines for all.

There are a number of such flexibilities which developing countries can use to address some of the negative consequences of pharmaceutical patents. The main flexibilities include: compulsory licensing; parallel importation; provisions relating to patentable subject matter; provisions relating to exceptions to patent rights; provisions relating to data protection; and provisions relating to abuse of rights, competition and the control of anti-competitive practices. The following is an overview of each of these flexibilities.¹⁰

¹⁰ For a detailed discussion of most of these public health-related TRIPS flexibilities see Correa (2000).