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

  • Format: Hardback, 270 pages, height x width: 234x156 mm, weight: 566 g, 1 Tables, black and white
  • Series: Routledge Research in Intellectual Property
  • Pub. Date: 21-May-2019
  • Publisher: Routledge
  • ISBN-10: 1138343382
  • ISBN-13: 9781138343382
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Intellectual Property and Access to Medicines in Africa: A Regional Framework for AccessLarger Image
  • Format: Hardback, 270 pages, height x width: 234x156 mm, weight: 566 g, 1 Tables, black and white
  • Series: Routledge Research in Intellectual Property
  • Pub. Date: 21-May-2019
  • Publisher: Routledge
  • ISBN-10: 1138343382
  • ISBN-13: 9781138343382
Other books in subject:
Permanent link: https://www.kriso.ee/db/9781138343382.html
Keywords:

A major target of Goal 3 of the Sustainable Development Goals adopted by the United Nations in 2015 is the elimination of ‘the epidemics of AIDS, tuberculosis, malaria and neglected tropical diseases’ and combating ‘hepatitis, water-borne diseases and other communicable diseases’. Intellectual property (IP) has been identified as one of the factors impeding access to affordable medicines in developing countries, especially in relation to the HIV pandemic.

This book examines the scope of the existing flexibilities in international IP law for promoting access to medicines. It analyses the factors accounting for the underutilisation of the flexibilities in Africa and the measures that African countries may adopt to address the IP barriers to access to medicines. It explores the regional strategies that Africa can adopt to resolve the tension between IP regimes and access to medicines. It also highlights how trade liberalisation and regional integration can play crucial roles in enhancing the use of TRIPS flexibilities, local pharmaceutical manufacturing and access to medicines in Africa.

By adopting qualitative research methods to investigate how African countries may effectively use IP to serve public health purposes through the stratagem of regional integration, this book will be a valuable contribution to the existing literature on IP.

Preface xii
Acknowledgements xiv
Table of cases xv
1 Introduction 1(11)
1.1 Patents and access to medicines
3(2)
1.2 The TRIPS flexibilities
5(2)
1.3 IP and access to medicines: an African free trade remedy
7(1)
1.4 The aim of this contribution
8(4)
2 The TRIPS compulsory licensing regime and access to medicines 12(39)
2.1 Introduction
12(8)
2.1.1 Compulsory licensing in historical context
13(4)
2.1.2 Compulsory licensing under TRIPS: the negotiations
17(3)
2.2 The scope of compulsory licensing under TRIPS Article 31
20(9)
2.2.1 Local working requirements and TRIPS
25(2)
2.2.2 TRIPS compulsory licensing regime - pre-Doha developments
27(2)
2.3 The Doha Declaration
29(16)
2.3.1 Doha Paragraph-6 Implementation Decision - the negotiations
31(2)
2.3.2 The Implementation of Paragraph 6 of Doha Declaration
33(2)
2.3.3 The Implementation Decision and regional trade agreements
35(2)
2.3.4 The Protocol Amending TRIPS
37(2)
2.3.5 Compulsory licensing under the Doha Paragraph-6 System
39(4)
2.3.6 Compulsory licensing and the TRIPS waivers for least developed countries
43(2)
2.4 Conclusion
45(6)
3 Compulsory licensing and access to medicines in Africa 51(27)
3.1 Introduction
51(1)
3.2 Justifying compulsory licensing
51(6)
3.2.1 Compulsory licensing and the access to medicines conundrum
54(1)
3.2.2 The precautionary principle and compulsory licensing
55(2)
3.3 Compulsory licensing and access to medicines
57(5)
3.3.1 Is compulsory licensing pivotal to access to medicines?
60(2)
3.4 Compulsory licensing in sub-Saharan Africa
62(10)
3.4.1 Ghanaian law
62(2)
3.4.2 Kenyan law
64(2)
3.4.3 Nigerian law
66(1)
3.4.4 Rwandan law
67(1)
3.4.5 South African law
68(1)
3.4.6 Malawian law
69(1)
3.4.7 Egyptian law
70(2)
3.5 Utilising compulsory licensing in Africa
72(2)
3.6 Conclusion
74(4)
4 The TRIPS regime for test data protection and access to medicines 78(29)
4.1 Introduction
78(6)
4.1.1 The nature of data exclusivity
79(3)
4.1.2 Test data protection under TRIPS
82(2)
4.2 Is Article 39 about data exclusivity?
84(6)
4.2.1 Elements of test data protection under the TRIPS Agreement
86(4)
4.2.1.1 Newness requirement
86(1)
4.2.1.2 Origination requirement
87(1)
4.2.1.3 Protection against unfair competition requirement
88(1)
4.2.1.4 Non-disclosure obligation and the public protection exception
89(1)
4.3 Data exclusivity and compulsory licensing
90(2)
4.3.1 Can test data be compulsorily licensed?
91(1)
4.4 Data exclusivity and biologics
92(3)
4.5 The global move towards a universal standard for data exclusivity
95(1)
4.6 Free trade agreements and data protection
96(1)
4.7 Data exclusivity and the right to health
97(2)
4.8 Test data and clinical trials reporting
99(1)
4.9 Data exclusivity in Africa
100(3)
4.9.1 Data exclusivity and access to medicines in Africa
101(2)
4.10 Conclusion
103(4)
5 The exhaustion doctrine, parallel trade and public health 107(34)
5.1 Introduction
107(1)
5.2 The concept of parallel importation
108(7)
5.2.1 The exhaustion doctrine and its basis
109(1)
5.2.2 The history of the exhaustion doctrine in national law
110(3)
5.2.3 Exhaustion of rights under TRIPS: a brief historical background
113(2)
5.3 Exhaustion of rights under the TRIPS agreement and the Paris Convention
115(5)
5.3.1 An analysis of exhaustion of patents rights under the TRIPS and the Paris Convention
117(1)
5.3.2 TRIPS exhaustion regime and the GATT
118(2)
5.4 Parallel importation in international trade
120(15)
5.4.1 Parallel importation and pharmaceuticals
123(5)
5.4.2 Differential pricing
128(2)
5.4.3 Parallel importation and competition policy
130(4)
5.4.4 Parallel importation of goods made under compulsory licensing
134(1)
5.5 Parallel trade as a mechanism for accessing medicines in Africa
135(1)
5.6 Conclusion
136(5)
6 Pharmaceutical patents and the obligation to protect health 141(46)
6.1 Introduction
141(6)
6.1.1 Theoretical foundation of human rights
143(2)
6.1.2 Human rights in international law
145(2)
6.2 The right to health in international law
147(5)
6.2.1 The right to health in international conventions
148(2)
6.2.2 Bioethics Declaration
150(1)
6.2.3 Access to medicines and the right to health
151(1)
6.3 Access to medicines and the Sustainable Development Goals (SDGs)
152(2)
6.4 Domestic implementation of the right to health
154(10)
6.4.1 Reasons for the reluctance to enforce social, economic and cultural rights
157(2)
6.4.2 Enforcement in national courts
159(2)
6.4.3 Enforcement in regional courts
161(3)
6.4.3.1 The Inter-American court experience
161(1)
6.4.3.2 The African human rights court
162(2)
6.5 Economic and property rights as human rights
164(5)
6.5.1 International trade law and human rights: is there a conflict?
167(2)
6.6 Access to medicines, the right to health and pharmaceutical patents
169(12)
6.6.1 Human rights, human security and public health
170(2)
6.6.2 The interface between trade, intellectual property and access to medicines
172(2)
6.6.3 Public interest measures in the TRIPS Agreement
174(5)
6.6.4 The right to health and the duty of multinational pharmaceutical companies
179(2)
6.7 Conclusion
181(6)
7 Patents, access to medicines and the human right to development 187(27)
7.1 Introduction
187(4)
7.1.1 The concept of development
189(1)
7.1.2 The legal order for international economic law
190(1)
7.2 The right to development as a human right
191(5)
7.2.1 The right to development under the African Charter
193(1)
7.2.2 TRIPS and development
194(2)
7.3 Intellectual property, economic growth and development
196(7)
7.3.1 Patent harmonisation and development
198(2)
7.3.2 The WTO and WIPO development agendas
200(3)
7.4 The TRIPS technology transfer regime and implications for development
203(4)
7.5 Pharmaceutical patents, health and development
207(2)
7.6 Conclusion
209(5)
8 Regional trade agreements, TRIPS-plus provisions and the African access to medicines conundrum 214(21)
8.1 Introduction
214(1)
8.2 RTAs and the WTO
215(1)
8.3 Regional trade agreement, TRIPS-plus provisions and access to medicines
216(7)
8.3.1 US-Australia Free Trade Agreement
217(2)
8.3.2 US - Morocco Free Trade Agreement
219(2)
8.3.3 United States-Mexico-Canada Agreement
221(2)
8.3.3.1 Evergreening of patents
221(1)
8.3.3.2 Extension of patent term for pharmaceutical products
221(1)
8.3.3.3 Data exclusivity
222(1)
8.3.3.4 Concluding remarks on RTAs
223(1)
8.4 Investor-state dispute settlement clauses and TRIPS flexibilities
223(8)
8.4.1 Access to medicines and investor-state dispute settlement under the US-Morocco Free Trade Agreement
224(4)
8.4.2 Eli Lily v Canada: a case study on how investment clauses in RTAs may erode TRIPS flexibilities
228(3)
8.5 Free trade agreements and access to medicines
231(1)
8.6 Conclusion
232(3)
9 Free trade and economic collaboration as paradigms for access to medicines 235(22)
9.1 Introduction
235(2)
9.1.1 Intellectual property and free trade
236(1)
9.2 The Treaty Establishing the African Economic Community (Abuja Treaty): a brief background
237(5)
9.2.1 The treaty establishing the African Economic Community and its provisions on economic collaboration in Africa
238(3)
9.2.2 The challenges of implementing the Abuja Treaty
241(1)
9.3 The role of the African Union
242(1)
9.4 Access to medicines and free trade
243(6)
9.4.1 The benefits of an African free-trade area
247(2)
9.5 The patent pool option
249(3)
9.5.1 Other recommendations
251(1)
9.6 Conclusion
252(5)
Index 257
Olasupo Owoeye, LL.B, PhD, is a Senior Lecturer in Law at the RMIT University, Melbourne, Australia.