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.

Intellectual property, trade, human rights and access to medicines in Africa: A reader by Atangcho N Akonumbo explores the current debates and conflicts pertaining to intellectual property (IP), trade and access to medicines in Africa as a public health issue, in a public health context. The Reader has a broad focus running across fourteen chapters. It examines the complex web of access to medicines, while introducing major concepts pertaining to access to medicines such as IP, trade, medicine and human rights, and provides a historical overview of the nexus between IP and human rights. It establishes the link between human rights, IP and access to medicines within the context of developing countries broadly and Africa in particular. The Reader discusses key flexibilities within the international IP framework championed by the TRIPS Agreement to enhance access to medicines, including compulsory licensing and parallel importation, while addressing impediments therein which provoked the Doha Declaration and arrangements thereafter. Also, it examines issues such as the implications of data exclusivity and linkage techniques; the role of anti-counterfeiting and competition laws in checking the effect of IP regimes; current threats to access to medicines at the international, regional and national levels such as the influence of regional or bilateral trade agreements; and research and development in respect of medicines for neglected and (re)emerging infectious diseases. It discusses the contributions of naturopathic and traditional medicines as parallel and complementary systems to modern medicine in the access to medicines landscape in the African context. The Reader further addresses the implications of the difficulty of access to medicines for women, children and other social minorities such as disabled persons and Lesbian, Gay, Bisexual, and Transgender (LGBT) persons. This Reader comes at a critical time, and potentially, a turning point in the history of public health crisis in Africa – when concerns about access to medicines have been heightened in the face of (re)emerging diseases and today the Covid-19 pandemic – a situation which has revealed gross lapses in public health governance. It is written in a simple language, making its content accessible to a wide audience. It contains informative and useful graphs, text boxes and illustrative excerpts from various primary and secondary sources. The Reader is likely to become an invaluable tool for a wide range of persons and institutions, including academics, students, legal practitioners, health professionals, drug procurement agencies, civil society organisations and the public at large, involved or interested in the access to medicines discourse.

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors – states, transnational business corporations, or civil society groups – and their influence on the structures – such as national and international agreements, organizations, and private entities – that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

The Agreement on Trade Related Aspects of Intellectual Property rights (TRIPS) requires all WTO members to adopt certain minimum standards for the protection of intellectual property rights including the rights of holders of patents for pharmaceutical products. The adoption of the standards delineated by the TRIPS Agreement appears to have resulted in significant loss of public health policy flexibilities for developing country members with respect to regulating the grant and use of pharmaceutical patents and controlling the cost of medicines. The Agreement, however, provides inherent flexibilities that are to enable member countries to take adequate measures to safeguard pubic health. This Study analyzes the extent to which countries in Sub-Saharan Africa have been able to utilize the flexibilities to improve access to HIV/Aids medicines. This is done primarily in relation to the two regional intellectual property organizations, the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Proprit Intellectuelle (OAPI), bearing in mind the close linkages between the legal instruments of these regional institutions and the domestic laws of their member countries. It has been observed that in spite of the availability of the flexibilities provided by the Agreement, obstacles to implementation in SSA center mainly on lack of awareness and political will and lack of efficient administrative structures and procedures for coordination and decision making. The Study also examines the option of local manufacture of HIV/Aids medicines, based on the experiences of four countries, evaluates challenges to the sustainability of this option in the SSA context andmakes recommendations based on key findings.

An exploration of the tension between human rights and patent law, with reference to developing countries' access to affordable medicines.

Although ideally a patent system for pharmaceuticals should serve to incentivize research into the development of new medicines, the COVID-19 pandemic has exposed the equal importance of drug access and affordability. This book, by focusing on the Brazilian rule which makes the grant of pharmaceutical patents dependent on the prior consent of the National Health Surveillance Agency (ANVISA), shows how the Brazilian model affords an example for other countries to follow in dealing with tensions between patent protection and the right to healthcare. Based on an empirical study in which the author examined 147 reports issued by ANVISA as a basis for its decisions, the book deals with such central questions concerning the interface of regulation and innovation in the patent system as the following: compatibility between ANVISA’s prior consent mechanism and the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; how “evergreening” and “trivial patents” undermine public health and access to medicines; ways of correcting abuses of patent rights and controlling quality of patents; and the discourse on health as a human right. Along with her examination of ANVISA reports, the author analyzes how Article 229-C LPI, which introduced the need of ANVISA’s prior consent to the patent grant of pharmaceuticals in Brazil, has been interpreted in Brazilian case law. Interviews with Brazilian experts are also included. In its commitment to harmonizing patent rights and the right to access of affordable medicines, Brazil’s patent system for pharmaceuticals stands out as a workable response to the basic problem of access to medicines in the developing world. By describing the successes and failures in the Brazilian policy of promoting drug access, this book helps policymakers in developing and emerging countries to better explore TRIPS flexibilities when dealing with similar problems, and provides practitioners in the law of the World Trade Organization, patent law, competition law, and health law with a guide to how a more equitable pharmaceutical patenting system could work in practice.

The book studies the pharmaceutical industry of India. It is one of the most successful stories of economic expansion and improvements in public health. Indian firms have made access to quality medicines possible and affordable in many developing countries. Indian pharmaceuticals are also exported on a large scale to the United States and other highly regulated markets. A wave of mergers, acquisitions and tie-ups point to growing integration between Indian firms and global pharma multinationals. Please note: Taylor & Francis does not sell or distribute the Hardback in India, Pakistan, Nepal, Bhutan, Bangladesh and Sri Lanka

Divided into three parts, this edited volume gives an overview of current topics in law and ethics in relation to intellectual property. It addresses practical issues encountered in everyday situations in politics, research and innovation, as well as some of the underlying theoretical concepts. In addition, it provides an insight into the process of international policy-making, showing the current problems in the area of intellectual property in science and research. It also highlights changes in the fundamental understanding of common and private property and the possible implications and challenges for society and politics.

This book discusses the impact of intellectual property and international investment agreements within Africa. It investigates how African nations can enhance their current intellectual property legislation across various regions of the continent, while simultaneously fostering the development of local industries and stimulating innovation and creativity within the region. Despite intellectual property remaining a major issue in global trade governance, African countries have room to maximise the advantages that global intellectual property law can offer. Highlighting discourse on investment, intellectual property, and competition policies in Africa, the book underscores the need for African nations to develop intellectual property frameworks that can facilitate economic transformation. Using data from international intellectual property conventions, WTO dispute settlements and African regional organisation conventions, the book is a comprehensive call to action for African intellectual property lawyers and policymakers. The book will be of interest to students and scholars in the field of intellectual property law and international investment law.

Across the world, developing countries are attempting to balance the international standards of intellectual property concerning pharmaceutical patents against the urgent need for accessible and affordable medicines. In this timely and necessary book, Monirul Azam examines the attempts of several developing countries to walk this fine line. He evaluates the experiences of Brazil, China, India, and South Africa for lessons to guide Bangladesh and developing nations everywhere. Azam's legal expertise, concern for public welfare, and compelling grasp of principal case studies make Intellectual Property and Public Health in the Developing World a definitive work. The developing world is striving to meet the requirements of the World Trade Organization's TRIPS Agreement on intellectual property. This book sets out with lucidity and insight the background of the TRIPS Agreement and its implications for pharmaceutical patents, the consequences for developing countries, and the efforts of certain representative nations to comply with international stipulations while still maintaining local industry and public health. Azam then brings the weight of this research to bear on the particular case of Bangladesh, offering a number of specific policy recommendations for the Bangladeshi government—and for governments the world over. Intellectual Property and Public Health in the Developing World is a must-read for public policy-makers, academics and students, non-governmental organizations, and readers everywhere who are interested in making sure that developing nations meet the health care needs of their people.