Improving Access to HIV/AIDS Medicines in Africa Trade-related Aspects of Intellectual Property Rights Flexibilities

by Osewe, Patrick Lumumba; Nkrumah, Yvonne K.; Sackey, Emmanuel

• ISBN13: 9780821375440
• ISBN10: 082137544X
• Format: Paperback
• Copyright: 2009-04-01
• Publisher: World Bank Publications
• More Book Details

Summary

Providing access to affordable, good quality HIV/AIDS medicines remains a challenge in Sub-Saharan Africa. Although patent protection is by no means the only barrier to access, it has significant implications for accessibility. Experiences from a number of countries show that local production of HIV/AIDS medicines depends not on research and technology, but also on highly regulated patents and intensive capital investment. These factors pose major challenges to African countries that have ventured into this undertaking. The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) requires all World Trade Organization members to adopt certain minimum standards for the protection of intellectual property rights, including the rights of pharmaceutical product patent holders. 'Improving Access to HIV/AIDS Medicines in Africa' analyzes the extent to which countries in Sub-Saharan Africa have been able to use flexibilities in the agreement to improve access to affordable antiretroviral (ARV) medicines. It also examines the option of local manufacture of ARV medicines-based on the experiences of Ghana, Kenya, South Africa, and Zimbabwe-and it evaluates factors that favor or hinder sustainable local production. Finally the book makes recommendations on how countries in the region can use the TRIPS flexibilities to improve access to life-saving medicines.

Table of Contents

Acknowledgments	p. vii
Abbreviations and Acronyms	p. ix
Overview	p. xi
Introduction	p. 1
The International Debate on TRIPS Flexibility	p. 2
Scope and Methodology of the Study	p. 5
Notes	p. 6
Overview of the TRIPS Agreement and Flexibilities	p. 9
Implementation of the TRIPS Flexibilities	p. 10
Exemptions from Patentability	p. 12
Transition Periods	p. 13
Compulsory Licensing and the Regional Trade Option	p. 15
Exhaustion of Rights and Parallel Importation	p. 20
Limits on Test Data Protection	p. 21
Bolar Exception	p. 22
Implementation Challenges	p. 22
Notes	p. 25
Local Production: Experiences in Four African Countries	p. 27
Zimbabwe: Varichem	p. 29
Kenya: Cosmos	p. 32
South Africa: Aspen	p. 35
Ghana: Danadams	p. 39
Local Production of ARVs in Perspective	p. 42
Notes	p. 44
Conclusions and Recommendations	p. 47
Conclusions	p. 47
Recommendations	p. 49
HIV/AIDS Medicines under Patent in Sub-Saharan Africa	p. 51
List of Persons Interviewed	p. 53
Bibliography	p. 57
Figures
Percentage of ARVs Purchased by Government of Ghana from Danadams and Other Firms 2005	p. 41
Comparison of Prices for Local and Imported Generic ARVs in Ghana, 2005	p. 42
Tables
TRIPS Flexibilities That Facilitate Protection of Public Health	p. 11
Key Socioeconomic Indicators	p. 28
Varichem's ARV Production Line	p. 30
Cosmos's ARV Production Line	p. 34
Supply of ARVs to the South Africa Department of Health	p. 38
Danadams's ARV Production Line	p. 40
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