Intellectual Property and Access to Medicines in Africa: A Regional Framework for Access

Cover
Half Title
Series Page
Title Page
Copyright Page
Dedication
Contents
Preface
Acknowledgements
Table of cases
1 Introduction
	1.1 Patents and access to medicines
	1.2 The TRIPS flexibilities
	1.3 IP and access to medicines: an African free trade remedy
	1.4 The aim of this contribution
2 The TRIPS compulsory licensing regime and access to medicines
	2.1 Introduction
		2.1.1 Compulsory licensing in historical context
		2.1.2 Compulsory licensing under TRIPS: the negotiations
	2.2 The scope of compulsory licensing under TRIPS Article 31
		2.2.1 Local working requirements and TRIPS
		2.2.2 TRIPS compulsory licensing regime – pre-Doha developments
	2.3 The Doha Declaration
		2.3.1 Doha Paragraph-6 Implementation Decision – the negotiations
		2.3.2 The Implementation of Paragraph 6 of Doha Declaration
		2.3.3 The Implementation Decision and regional trade agreements
		2.3.4 The Protocol Amending TRIPS
		2.3.5 Compulsory licensing under the Doha Paragraph-6 System
		2.3.6 Compulsory licensing and the TRIPS waivers for least developed countries
	2.4 Conclusion
3 Compulsory licensing and access to medicines in Africa
	3.1 Introduction
	3.2 Justifying compulsory licensing
		3.2.1 Compulsory licensing and the access to medicines conundrum
		3.2.2 The precautionary principle and compulsory licensing
	3.3 Compulsory licensing and access to medicines
		3.3.1 Is compulsory licensing pivotal to access to medicines?
	3.4 Compulsory licensing in sub-Saharan Africa
		3.4.1 Ghanaian law
		3.4.2 Kenyan law
		3.4.3 Nigerian law
		3.4.4 Rwandan law
		3.4.5 South African law
		3.4.6 Malawian law
		3.4.7 Egyptian law
	3.5 Utilising compulsory licensing in Africa
	3.6 Conclusion
4 The TRIPS regime for test data protection and access to medicines
	4.1 Introduction
		4.1.1 The nature of data exclusivity
		4.1.2 Test data protection under TRIPS
	4.2 Is Article 39 about data exclusivity?
		4.2.1 Elements of test data protection under the TRIPS Agreement
			4.2.1.1 Newness requirement
			4.2.1.2 Origination requirement
			4.2.1.3 Protection against unfair competition requirement
			4.2.1.4 Non-disclosure obligation and the public protection exception
	4.3 Data exclusivity and compulsory licensing
		4.3.1 Can test data be compulsorily licensed?
	4.4 Data exclusivity and biologics
	4.5 The global move towards a universal standard for data exclusivity
	4.6 Free trade agreements and data protection
	4.7 Data exclusivity and the right to health
	4.8 Test data and clinical trials reporting
	4.9 Data exclusivity in Africa
		4.9.1 Data exclusivity and access to medicines in Africa
	4.10 Conclusion
5 The exhaustion doctrine, parallel trade and public health
	5.1 Introduction
	5.2 The concept of parallel importation
		5.2.1 The exhaustion doctrine and its basis
		5.2.2 The history of the exhaustion doctrine in national law
		5.2.3 Exhaustion of rights under TRIPS: a brief historical background
	5.3 Exhaustion of rights under the TRIPS agreement and the Paris Convention
		5.3.1 An analysis of exhaustion of patents rights under the TRIPS and the Paris Convention
		5.3.2 TRIPS exhaustion regime and the GATT
	5.4 Parallel importation in international trade
		5.4.1 Parallel importation and pharmaceuticals
		5.4.2 Differential pricing
		5.4.3 Parallel importation and competition policy
		5.4.4 Parallel importation of goods made under compulsory licensing
	5.5 Parallel trade as a mechanism for accessing medicines in Africa
	5.6 Conclusion
6 Pharmaceutical patents and the obligation to protect health
	6.1 Introduction
		6.1.1 Theoretical foundation of human rights
		6.1.2 Human rights in international law
	6.2 The right to health in international law
		6.2.1 The right to health in international conventions
		6.2.2 Bioethics Declaration
		6.2.3 Access to medicines and the right to health
	6.3 Access to medicines and the Sustainable Development Goals (SDGs)
	6.4 Domestic implementation of the right to health
		6.4.1 Reasons for the reluctance to enforce social, economic and cultural rights
		6.4.2 Enforcement in national courts
		6.4.3 Enforcement in regional courts
			6.4.3.1 The Inter-American court experience
			6.4.3.2 The African human rights court
	6.5 Economic and property rights as human rights
		6.5.1 International trade law and human rights: is there a conflict?
	6.6 Access to medicines, the right to health and pharmaceutical patents
		6.6.1 Human rights, human security and public health
		6.6.2 The interface between trade, intellectual property and access to medicines
		6.6.3 Public interest measures in the TRIPS Agreement
		6.6.4 The right to health and the duty of multinational pharmaceutical companies
	6.7 Conclusion
7 Patents, access to medicines and the human right to development
	7.1 Introduction
		7.1.1 The concept of development
		7.1.2 The legal order for international economic law
	7.2 The right to development as a human right
		7.2.1 The right to development under the African Charter
		7.2.2 TRIPS and development
	7.3 Intellectual property, economic growth and development
		7.3.1 Patent harmonisation and development
		7.3.2 The WTO and WIPO development agendas
	7.4 The TRIPS technology transfer regime and implications for development
	7.5 Pharmaceutical patents, health and development
	7.6 Conclusion
8 Regional trade agreements, TRIPS-plus provisions and the African access to medicines conundrum
	8.1 Introduction
	8.2 RTAs and the WTO
	8.3 Regional trade agreement, TRIPS-plus provisions and access to medicines
		8.3.1 US-Australia Free Trade Agreement
		8.3.2 US – Morocco Free Trade Agreement
		8.3.3 United States-Mexico-Canada Agreement
			8.3.3.1 Evergreening of patents
			8.3.3.2 Extension of patent term for pharmaceutical products
			8.3.3.3 Data exclusivity
			8.3.3.4 Concluding remarks on RTAs
	8.4 Investor-state dispute settlement clauses and TRIPS flexibilities
		8.4.1 Access to medicines and investor-state dispute settlement under the US-Morocco Free Trade Agreement
		8.4.2 Eli Lily v Canada: a case study on how investment clauses in RTAs may erode TRIPS flexibilities
	8.5 Free trade agreements and access to medicines
	8.6 Conclusion
9 Free trade and economic collaboration as paradigms for access to medicines
	9.1 Introduction
		9.1.1 Intellectual property and free trade
	9.2 The Treaty Establishing the African Economic Community (Abuja Treaty): a brief background
		9.2.1 The treaty establishing the African Economic Community and its provisions on economic collaboration in Africa
		9.2.2 The challenges of implementing the Abuja Treaty
	9.3 The role of the African Union
	9.4 Access to medicines and free trade
		9.4.1 The benefits of an African free-trade area
	9.5 The patent pool option
		9.5.1 Other recommendations
	9.6 Conclusion
Index