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Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many. 0The AIDS crisis in the late nineties brought access to medicines challenges to the public?s attention, when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis ? 8,000 people dying daily ? the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of low-priced generic HIV medicines. 0But now, high prices of new medicines - for example, for cancer, tuberculosis and hepatitis C - are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises. 0This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.
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.
A comprehensive review of Hong Kong's pharmaceutical patent law that will influence debate and inform public policy.
In The Global Politics of Pharmaceutical Monopoly Power, researcher and global advocate Ellen 't Hoen explains how new global rules for pharmaceutical patenting impact access to medicines in the developing world. The book gives an account of the current debates on intellectual property, access to medicines, and medical innovation, and provides historical context that explains how the current system emerged. This book supports major policy changes in the management of pharmaceutical patents and the way medical innovation is financed in order to protect public health and, in particular, promote access to essential medicines for all. The Open Society Institute provided support to translate this report into Russian.
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.
Transnational Legal Orders offers an empirically grounded approach to the emergence of legal orders beyond nation-states that reframes the study of law and society.
Patent rights on pharmaceutical products are one of the factors responsible for the lack of access to affordable medicines in developing countries. In this work, Emmanuel Kolawole Oke provides a systematic analysis of the tension between patent rights and human rights law, contending that, in order to preserve their patent policy space and secure access to affordable medicines for their citizens, developing countries should incorporate a model of human rights into the design, implementation, interpretation, and enforcement of their national patent laws. Through a comprehensive analysis of court decisions from three key developing countries (India, Kenya, and South Africa), Oke assesses the effectiveness of national courts in resolving conflicts between patent rights and the right to health, and demonstrates how a model of human rights can be incorporated into the adjudication of patent rights.
In pharmaceutical patent law, the problem of lack of policy direction and inappropriate legal framework is widespread - particularly among jurisdictions with little to no pharmaceutical research or manufacturing. This book aims to inform public policy and influence debate through a comprehensive review of Hong Kong's pharmaceutical patent law. By demonstrating the need for a holistic review of pharmaceutical patent laws and evaluating Hong Kong's system in light of health policy, economic and social factors, Bryan Mercurio recommends changes to the legal framework and constructs a more efficient and effective system for Hong Kong. He thoroughly evaluates the international framework and best practice models to offer a global perspective to each issue before providing local context in the analysis. While the focus of the book is Hong Kong, the analysis on pharmaceutical patent law and policy extends to other jurisdictions facing issues on reforming their national system.
Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
The book engages with a broad range of new case studies, providing a detailed examination of options for the resolution of access-to-medicine issues at global, national and local levels. In addition, the book reflects the significant progress in international and national patent law and in international policy-making in this area.