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