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: III.4 Difficulties in Establishing Efficient Pharmaceutical Management and Procurement Systems

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.4 Difficulties in Establishing Efficient Pharmaceutical Management and Procurement Systems

Another challenge that faces developing countries in their efforts to improve availability and access to essential medicines relates to establishing efficient pharmaceutical management and procurement systems. Putting in place efficient management systems for pharmaceutical procurement can be a costly and complex process requiring vast resources and technical know-how. The problems can be particularly acute for small countries whose average drug prices are generally high due to lack of economies of scale. The cost of taking care of quality and supply chain issues is also high.

The lack of efficient and cost-effective management and procurement systems therefore has an effect on prices, on quality, on rational use of drugs as well as on availability of medicines generally. Consequently, the use of TRIPS flexibilities to improve availability and access to medicines faces challenges due to lack of resources and technical expertise to administer efficient pharmaceutical management and procurement systems.