Pharmaceutical Patent Protection and Development in Sub-Saharan Africa
Pharmaceutical Patent Protection and Development in Sub-Saharan Africa

Author: Poku Adusei

Publisher:

Published: 2011

Total Pages:

ISBN-13:

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This thesis critically investigates patent protection of medicines in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter SSA or Africa). The thesis begins by outlining the systemic problems associated with the prevailing globalized patent regime and the regime's inability to promote access to life-saving medicines at affordable prices in poor regions such as SSA. The thesis then goes on to argue that for pharmaceutical patents to retain their relevance in SSA countries human development concepts must be integrated into global patent law- and policy-making. An integrative approach here implies developing additional public health and human development exceptions/limitations to the exercise of patent rights with the goal of scaling up access to medicines to treat epidemics in SSA. The interplay of the sub-themes of laws, institutions, practices, and politics as chief instruments...

Patenting of Pharmaceuticals and Development in Sub-Saharan Africa
Patenting of Pharmaceuticals and Development in Sub-Saharan Africa

Author: POKU ADUSEI

Publisher: Springer Science & Business Media

Published: 2012-10-25

Total Pages: 312

ISBN-13: 3642325149

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This book critically investigates the patent protection of medication in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter “SSA” or “Africa”). The book outlines the systemic problems associated with the prevailing globalized patent regime and the regime’s inability to promote access to life-saving medication at affordable prices in SSA. It argues that for pharmaceutical patents to retain their relevance in SSA countries, human development concepts must be integrated into global patent law- and policy-making. An integrative approach implies developing additional public health and human development exceptions/limitations to the exercise of patent rights with the goal of scaling up access to medication that can treat epidemics in SSA. By drawing on multiple perspectives of laws, institutions, practices, and politics, the book suggests that SSA countries adopt an evidence-based approach to implementing global patent standards in domestic jurisdictions. This evidence-based approach would include mechanisms like local need assessments and the use of empirical data to shape domestic patent law-making endeavors. The approach also implies revising patent rules and policies with a pro-poor and pro-health emphasis, so that medication will be more affordable and accessible to the citizens of SSA countries. It also suggests considering the opinions of individuals and pro-access institutions in enacting crucial pieces of health-related statutes in SSA countries. The approach in this book is sensitive to the public health needs of the citizens affected by epidemics and to the imperative of building local manufacturing facilities for pharmaceutical research and development in SSA.

Improving Access to HIV/AIDS Medicines in Africa
Improving Access to HIV/AIDS Medicines in Africa

Author: Patrick Lumumba Osewe

Publisher: World Bank Publications

Published: 2008-01-01

Total Pages: 84

ISBN-13: 0821375458

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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.

Improving Access to HIV/AIDS Medicines in Africa
Improving Access to HIV/AIDS Medicines in Africa

Author: Patrick Lumumba Osewe

Publisher: World Bank Publications

Published: 2008

Total Pages: 65

ISBN-13: 9780821375440

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Providing access to affordable, good quality HIV/AIDS medicines remains a challenge in Sub-Saharan Africa. Although patent protection is by no means the only barrier to access, it has significant implications for accessibility. Experiences from a number of countries show that local production of HIV/AIDS medicines depends not on research and technology, but also on highly regulated patents and intensive capital investment. These factors pose major challenges to African countries that have ventured into this undertaking. The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) requires all World Trade Organization members to adopt certain minimum standards for the protection of intellectual property rights, including the rights of pharmaceutical product patent holders. Improving Access to HIV/AIDS Medicines in Africa analyses the extent to which countries in Sub-Saharan Africa have been able to use flexibilities in the agreement to improve access to affordable antiretroviral (ARV) medicines. It also examines the option of local manufacture of ARV medicines - based on the experiences of Ghana, Kenya, South Africa, and Zimbabwe - and it evaluates factors that favor or hinder sustainable local production. Finally the book makes recommendations on how countries in the region can use the TRIPS flexibilities to improve access to life-saving medicines.

The Political Economy of Pharmaceutical Patents
The Political Economy of Pharmaceutical Patents

Author: Sherry S. Marcellin

Publisher: Routledge

Published: 2016-02-24

Total Pages: 227

ISBN-13: 1317020804

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This book provides a fresh, multidisciplinary, and exciting look at the making and remaking of pharmaceutical patents at the GATT/WTO, by utilising a Coxian political economy of continuity and change in the global political economy (GPE). Marcellin focuses on the role of the transnational drug industry in the making of the patent provisions in the original TRIPS Agreement and consequently, the role of the African Group at the WTO in the remaking of those patent provisions.

Patents and Pharmaceutical Drugs
Patents and Pharmaceutical Drugs

Author: Julio J. Nogués

Publisher: World Bank Publications

Published: 1990

Total Pages: 46

ISBN-13:

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Lengthen effective patent protection in industrial countries and press developing countries to introduce patent protection. These two tactics have become important parts of the R&D-intensive pharmaceutical industry's strategy to regain losses in market share associated with more stringent drug safety regulations and increased competition from generic drug companies.

TRIPS and Access to Medicines
TRIPS and Access to Medicines

Author: Renata Curzel

Publisher: Kluwer Law International B.V.

Published: 2020-12-10

Total Pages: 325

ISBN-13: 9403528745

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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.

Intellectual Property, Pharmaceuticals and Public Health
Intellectual Property, Pharmaceuticals and Public Health

Author: Kenneth C. Shadlen

Publisher: Edward Elgar Publishing

Published: 2011-01-01

Total Pages: 353

ISBN-13: 0857938614

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'This impressive collection offers fascinating new perspectives on the impact of pharmaceutical patents on access to medicines in developing countries. The volume's editors have put together an important book that sets out clearly the challenges to public health in a wide range of national contexts. The book will be a valuable text for all scholars and decision-makers interested in the global politics of intellectual property rights and public health.' – Duncan Matthews, Queen Mary, University of London, UK This up-to-date book examines pharmaceutical development, access to medicines, and the protection of public health in the context of two fundamental changes that the global political economy has undergone since the 1970s, the globalization of trade and production and the increased harmonization of national regulations on intellectual property rights. With authors from eleven different countries presenting case studies of national experiences in Africa, Asia and the Americas, the book analyzes national strategies to promote pharmaceutical innovation, while at the same time assuring widespread access to medicines through generic pharmaceutical production and generic pharmaceutical importation. The expert chapters focus on patents as well as an array of regulatory instruments, including pricing and drug registration policies. Presenting in-depth analysis and original empirical research, this book will strongly appeal to academics and students of intellectual property, international health, international political economy, international development and law.