Intellectual Property Law and Access to Medicines


Book Description

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.




Private Patents and Public Health


Book Description

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.




Vaccines, Medicines and COVID-19


Book Description

This open access book is a collection of research papers on COVID-19 by Germán Velásquez from 2020 and early 2021 that help to answer the question: How can an agency like the World Health Organization (WHO) be given a stronger voice to exercise authority and leadership? The considerable health, economic and social challenges that the world faced at the beginning of 2020 with COVID-19 continued and worsened in many parts of the world in the second-half of 2020 and into 2021. Many of these countries and nations wanted to explore COVID-19 on their own, sometimes without listening to the main international health bodies such as WHO, an agency of the United Nations system with long-standing experience and vast knowledge at the global level and of which all countries in the world are members. In this single volume, the chapters present the progress of thinking and debate — particularly in relation to drugs and vaccines — that would enable a response to the COVID-19 pandemic or to subsequent crises that may arise. Among the topics covered: COVID-19 Vaccines: Between Ethics, Health and Economics Medicines and Intellectual Property: 10 Years of the WHO Global Strategy Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock Intellectual Property and Access to Medicines and Vaccines The World Health Organization Reforms in the Time of COVID-19 Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice? is essential reading for negotiators from the 194 member countries of the World Health Organization (WHO); World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) staff participating in these negotiations; academics and students of public health, medicine, health sciences, law, sociology and political science; and intergovernmental organizations and non-governmental organizations that follow the issue of access to treatments and vaccines for COVID-19.




Interpreting TRIPS


Book Description

Protection of intellectual property rights (IPRs) has become a global issue. The Trade-Related Aspects of Intellectual Property (TRIPS) Agreement outlines the minimum standards for IPR protection for WTO members and offers a global regime for IPR protection. However, the benefits of TRIPS are more questionable in poorer countries where national infrastructure for research and development (R&D) and social protection are inadequate, whereas the cost of innovation is high. Today, after more than a decade of intense debate over global IPR protection, the problems remain acute, although there is also evidence of progress and cooperation. This book examines various views of the role of IPRs as incentives for innovation against the backdrop of development and the transfer of technology between globalised, knowledge-based, high technology economies. The book retraces the origins, content and interpretations of the TRIPS Agreement, including its interpretations by WTO dispute settlement organs. It also analyses sources of controversy over IPRs, examining pharmaceutical industry strategies of emerging countries with different IPR policies. The continuing international debate over IPRs is examined in depth, as are TRIPS rules and the controversy about implementing the 'flexibilities' of the Agreement in the light of national policy objectives. The author concludes that for governments in developing countries, as well as for their business and scientific communities, a great deal depends on domestic policy objectives and their implementation. IPR protection should be supporting domestic policies for innovation and investment. This, in turn requires a re-casting of the debate about TRIPS, to place cooperation in global and efficient R&D at the heart of concerns over IPR protection.




Compulsory Patent Licensing and Access to Medicines: A Silver Bullet Approach to Public Health?


Book Description

This timely monograph focuses on India and Brazil’s use of compulsory licensing, one of the most significant and controversial TRIPS flexibilities. This is a topical work at this critical time when the COVID-19 has stirred up the debate about compulsory licensing and access to medicines. A closer look into the historical use of compulsory licences in certain countries can offer some takeaways for the current situation. The author studies historical developments and political conditions of the patent system and compulsory licensing from the earliest stage to the modern arena, with a great emphasis on TRIPS. After conducting a cross-national study of India and Brazil, the book moves on to evaluate the different philosophies on compulsory licensing of multilateral organizations such as the EU, the WIPO, the WTO, and NGOs. This important book will strongly appeal to intellectual property students, academics, policymakers, and lawyers practicing in the area. It will also be of interest to academics working in the areas of international law, development, and public health as well as state actors and others with relevant concerns working in multilateral organizations.




Access to Medicine in the Global Economy


Book Description

The issue of how patents impact medicine has increased in significance within the last decade. The book provides an explanation of the current international infrastructure and explains how competing patent perspectives play a thus far unacknowledged role in promoting distortion and confusion.




Human Rights and the WTO


Book Description

This book examines one of the most controversial aspects of the world trading system: patents and access to medication, and offers approaches to tackle the issue of how to better accommodate human rights in the trading system.




Equitable Access to High-Cost Pharmaceuticals


Book Description

Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines. - Evaluates impact and efficacy of current access policies and pricing regulation of high-cost drugs - Incorporates existing guidelines and recommendations by international organizations - Compares and contrasts how different countries fund and police high-cost drug access - Explores novel and emergent policies, including managed entry agreement, analysis of real world data and differential pricing - Reviews novel pharmaceuticals of current research interest




The Global Governance of HIV/AIDS


Book Description

ÔHIV/AIDS remains a major global health problem, despite the progress made in its prevention and treatment. Addressing this problem is not only a matter of more and better drugs, they need to be widely accessible and be affordable to the poor. This book makes, with a much welcomed interdisciplinary approach, an excellent contribution to understanding how the intellectual property regime can influence health policies and the lives of millions of people affected by the disease. The analysis provided by the various authors that contributed to this book will be of relevance not only to those working in the area of HIV/AIDS, but to those more broadly interested in public health governance and the role of intellectual property rights.Õ Ð Carlos Correa, University of Buenos Aires, Argentina ÔThis is an important, innovative and, at times, controversial collection. Inter-disciplinary in approach, this collection will have appeal to those concerned with the global injustice in the context of HIV/AIDS. Investigating the legal, political and economic determinants of access to essential medicines, this is thought provoking collection which will resonate with many in both the academic and public policy community.Õ Ð Bryan Mercurio, The Chinese University of Hong Kong This important book brings together leading scholars from multiple disciplines, including intellectual property, human rights, public health, and development studies, as well as activists to critically reflect on the global health governance regime. The Global Governance of HIV/AIDS explores the implications of high international intellectual property standards for access to essential medicines in developing countries. With a focus on HIV/AIDS governance, the volume provides a timely analysis of the international legal and political landscape, the relationship between human rights and intellectual property, and emerging issues in global health policy. It concludes with concrete strategies on how to improve access to HIV/AIDS medicines. This interdisciplinary, global, and up-to-date book will strongly appeal to academics in law, international relations, health policy and public policy, as well as students, policymakers and activists.




Intellectual Property, Pharmaceuticals and Public Health


Book Description

'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.