Utilizing TRIPS Flexibilities for Public Health Protection Through South-South Regional Frameworks: III. CONSTRAINTS ON NATIONAL EFFORTS TO IMPLEMENT TRIPS FLEXIBILITIES FOR PUBLIC HEALTH PURPOSES

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

III. CONSTRAINTS ON NATIONAL EFFORTS TO IMPLEMENT TRIPS FLEXIBILITIES FOR PUBLIC HEALTH PURPOSES

Incorporating the public health-related TRIPS flexibilities into national law and policy is necessary but not sufficient to deal with the patent-related obstacles to improving access to medicines. There are therefore two levels of constraints that need to be addressed if developing countries are effectively to use TRIPS flexibilities for public health purposes.

The first level relates to constraints associated with the incorporation and general implementation of the TRIPS flexibilities themselves. The second level relates to constraints in the framing and implementation of supporting legal and policy measures such as those concerning local innovation and production of pharmaceuticals. For example, legal and policy measures need to be introduced to guarantee availability of alternative sources of medicines, either through local production or through importation; to assure the quality of the medicines; to ensure expedited registration of essential generics; and to ensure cost effectiveness of the resources spent in the procurement of medical supplies. The constraints in implementing these secondary legal and policy measures at the national level have the effect of inhibiting the effective use of the TRIPS flexibilities.

The main constraints at the second level include the lack of domestic pharmaceutical research and manufacturing capacities; insufficient technical and infrastructural capacities for medicines regulation; difficulties in establishing efficient pharmaceutical management and procurement systems; bilateral and other political pressures against the use of TRIPS flexibilities; lack of capacity to address anti-competitive practices and abuse of patent rights; and difficulties in accessing pricing and patent status information.