Table Of ContentIntellectual Property and
Access to Medicines in Africa
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 flexi-
bilities, 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.
Olasupo Owoeye, LL.B, PhD, is a Senior Lecturer in Law at the RMIT U niversity,
Melbourne, Australia.
Routledge Research in Intellectual Property
Intellectual Property and Access to Medicines in Africa
A Regional Framework for Access
Olasupo Owoeye
Intellectual Property Branding in the Developing World
Tshimanga Kongolo
Intellectual Property Policy, Law and Administration in Africa
Exploring Continental and Sub-Regional Co-Operation
Caroline Bongiwe Ncube
Intellectual Property Rights and Competition in Standard Setting
Objectives and Tensions
Valerio Torti
Re-Thinking Intellectual Property
The Political Economy of Copyright Protection in the Digital Era
YiJun Tian
The Development of Intellectual Property Regimes in the Middle East
David Price
Intellectual Property, Community Rights and Human Rights
The Biological and Genetic Resources of Developing Countries
Marcelin Tonye Mahop
Intellectual Property in Global Governance
The Crisis of Equity in the Knowledge Economy
Chidi Oguamanam
For more information about this series, please visit: https://www.routledge.com
Intellectual Property and
Access to Medicines in Africa
A Regional Framework for Access
Olasupo Owoeye
First published 2019
by Routledge
2 Park Square, Milton Park, Abingdon, Oxon OX14 4RN
and by Routledge
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Routledge is an imprint of the Taylor & Francis Group, an informa business
© 2019 Olasupo Owoeye
The right of Olasupo Owoeye to be identified as author of this work
has been asserted by him in accordance with sections 77 and 78 of the
Copyright, Designs and Patents Act 1988.
All rights reserved. No part of this book may be reprinted or reproduced
or utilised in any form or by any electronic, mechanical, or other means,
now known or hereafter invented, including photocopying and recording,
or in any information storage or retrieval system, without permission in
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or registered trademarks, and are used only for identification and
explanation without intent to infringe.
British Library Cataloguing-in-Publication Data
A catalogue record for this book is available from the British Library
Library of Congress Cataloging-in-Publication Data
Names: Owoeye, Olasupo, author.
Title: Intellectual property and access to medicines in Africa: a regional
framework for access / by Olasupo Owoeye.
Description: Abingdon, Oxon; New York, NY: Routledge, 2019. |
Series: Routledge research in intellectual property | Based on author’s
thesis (doctoral – University of Tasmania, 2014) issued under title:
Patents for pharmaceuticals and access to affordable medicines: towards
an all-encompassing access paradigm for Africa. | Includes bibliographical
references and index.
Identifiers: LCCN 2019005010 | ISBN 9781138343382 (hardback)
Subjects: LCSH: Drugs—Africa—Patents. | Pharmacy—Law and
legislation—Africa. | Patents (International law)
Classification: LCC KQC391.M44 O954 2019 | DDC 346.604/86—dc23
LC record available at https://lccn.loc.gov/2019005010
ISBN: 978-1-138-34338-2 (hbk)
ISBN: 978-0-429-43918-6 (ebk)
Typeset in Galliard
by codeMantra
To my adorable wife, Busayo, for the great sacrifices and
the unending support, and our children; Dara, Ogo and
Ayanfe
Contents
Preface xii
Acknowledgements xiv
Table of cases xv
1 Introduction 1
1.1 Patents and access to medicines 3
1.2 The TRIPS flexibilities 5
1.3 IP and access to medicines: an African free
trade remedy 7
1.4 The aim of this contribution 8
2 The TRIPS compulsory licensing regime and access
to medicines 12
2.1 Introduction 12
2.1.1 Compulsory licensing in historical context 13
2.1.2 Compulsory licensing under TRIPS:
the negotiations 17
2.2 The scope of compulsory licensing under
TRIPS Article 31 20
2.2.1 Local working requirements and TRIPS 25
2.2.2 TRIPS compulsory licensing
regime – pre-Doha developments 27
2.3 The Doha Declaration 29
2.3.1 Doha Paragraph-6 Implementation
Decision – the negotiations 31
2.3.2 The Implementation of Paragraph 6
of Doha Declaration 33
2.3.3 The Implementation Decision and regional
trade agreements 35
2.3.4 The Protocol Amending TRIPS 37
2.3.5 Compulsory licensing under the Doha
Paragraph-6 System 39
viii Contents
2.3.6 C ompulsory licensing and the TRIPS waivers
for least developed countries 43
2.4 Conclusion 45
3 Compulsory licensing and access to medicines in Africa 51
3.1 Introduction 51
3.2 Justifying compulsory licensing 51
3.2.1 Compulsory licensing and the access to
medicines conundrum 54
3.2.2 The precautionary principle and
compulsory licensing 55
3.3 Compulsory licensing and access to medicines 57
3.3.1 Is compulsory licensing pivotal to
access to medicines? 60
3.4 Compulsory licensing in sub-Saharan Africa 62
3.4.1 Ghanaian law 62
3.4.2 Kenyan law 64
3.4.3 Nigerian law 66
3.4.4 Rwandan law 67
3.4.5 South African law 68
3.4.6 Malawian law 69
3.4.7 Egyptian law 70
3.5 Utilising compulsory licensing in Africa 72
3.6 Conclusion 74
4 The TRIPS regime for test data protection and access
to medicines 78
4.1 Introduction 78
4.1.1 The nature of data exclusivity 79
4.1.2 Test data protection under TRIPS 82
4.2 Is Article 39 about data exclusivity? 84
4.2.1 Elements of test data protection under
the TRIPS Agreement 86
4.2.1.1 Newness requirement 86
4.2.1.2 Origination requirement 87
4.2.1.3 Protection against unfair competition
requirement 88
4.2.1.4 Non-disclosure obligation and the
public protection exception 89
4.3 Data exclusivity and compulsory licensing 90
4.3.1 Can test data be compulsorily licensed? 91
4.4 Data exclusivity and biologics 92
4.5 The global move towards a universal standard for data
exclusivity 95
4.6 Free trade agreements and data protection 96
Contents ix
4.7 Data exclusivity and the right to health 97
4.8 Test data and clinical trials reporting 99
4.9 Data exclusivity in Africa 100
4.9.1 Data exclusivity and access to medicines
in Africa 101
4.10 Conclusion 103
5 The exhaustion doctrine, parallel trade and public health 107
5.1 Introduction 107
5.2 The concept of parallel importation 108
5.2.1 The exhaustion doctrine and its basis 109
5.2.2 The history of the exhaustion doctrine in
national law 110
5.2.3 Exhaustion of rights under TRIPS: a brief
historical background 113
5.3 Exhaustion of rights under the TRIPS agreement
and the Paris Convention 115
5.3.1 An analysis of exhaustion of patents rights
under the TRIPS and the Paris Convention 117
5.3.2 TRIPS exhaustion regime and the GATT 118
5.4 Parallel importation in international trade 120
5.4.1 Parallel importation and pharmaceuticals 123
5.4.2 Differential pricing 128
5.4.3 Parallel importation and competition policy 130
5.4.4 Parallel importation of goods made under
compulsory licensing 134
5.5 Parallel trade as a mechanism for accessing
medicines in Africa 135
5.6 Conclusion 136
6 Pharmaceutical patents and the obligation to
protect health 141
6.1 Introduction 141
6.1.1 Theoretical foundation of human rights 143
6.1.2 Human rights in international law 145
6.2 The right to health in international law 147
6.2.1 The right to health in international conventions 148
6.2.2 Bioethics Declaration 150
6.2.3 Access to medicines and the right to health 151
6.3 Access to medicines and the Sustainable Development
Goals (SDGs) 152
6.4 Domestic implementation of the right to health 154
6.4.1 Reasons for the reluctance to enforce social,
economic and cultural rights 157
