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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.
Under the auspices of the Max Planck Institute for Intellectual Property and Competition Law (now the Max Planck Institute for Innovation and Competition). And Institutum Iurisprudentiae, Academia Sinica, a group of twenty scholars from around the world gathered to study the experiences made with regards to compulsory licensing. The results are demonstrated in this book. Different articles analyze how the international conventions on intellectual property may be interpreted and explore the related doctrinal groundwork surrounding compulsory patent licensing and beyond. It is shown how the compulsory licensing regime could be transformed into a truly workable mechanism facilitating the speedy use and dissemination of innovation and other subject matters of protection.
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.
The growing presence of technology has created significant changes within the healthcare industry. With the ubiquity of these technologies, there is now an increasing need for more advanced legal procedures. Patent Law and Intellectual Property in the Medical Field is a pivotal reference source for the latest research in support of developing convergent and interoperable systems to increase awareness and applicability of legal aspects in the medical field. Featuring extensive coverage on relevant areas such as compulsory licensing, parallel importing, and protection law, this publication is an ideal resource for researchers, medical and law professionals, academics, graduate students, and practitioners engaged in medical practice.
[The objective of this thesis is to examine the implementation by three carefully selected developing countries of one of the most significant and controversial TRIPS flexibilities - compulsory licensing - so as to meet their differing pharmaceutical needs. This objective will be achieved by adopting a comparative approach between international (TRIPS) and domestic (India, Brazil and Thailand) patent laws, and by conducting a cross-national study of these patent regimes. This thesis critically evaluates the compulsory licensing mechanism of the aforementioned countries, each considered to be an emerging economy, capable of challenging the dominance of OECD nations. The findings suggest that each country's application of compulsory licensing is closely linked to two factors: how it has implemented TRIPS and, its pharmaceutical manufacturing capacity. Where a state capitalises on TRIPS flexibilities and has a well-developed manufacturing capacity, it is unlikely to use compulsory licensing (e.g. India). In contrast, where TRIPS flexibilities are underutilised combined with a low industrial development, then the grant of compulsory licences is highly likely (e.g. Brazil and Thailand).On the one hand, all the compulsory licence grants, to some extent, produced significant effects on society. In the short-term run, these licences eroded the monopoly of patent holding companies, driving down the price of medicine, thereby increasing the number of patients in treatment. Furthermore, as regards India and Brazil, mandatory licensing also resulted in price deductions for other medicines which were not subject to the compulsory licence. Somewhat surprisingly, in all three country case studies, the generics were not made at the cheapest price, compared with the substitutes available on the market, an important consideration for parties seeking a compulsory licence.This work concludes that each country case study has developed its own distinctive regime. The fact that India's compulsory licences were initiated by private companies signifies that this legal tool has mainly served its thriving pharmaceutical industry. An absence of governmental participation in India has caused the country's mandatory licensing to be seen as purely a legal issue. Meanwhile, Brazil and Thailand applied government use licences to respond to their national health needs. This gave a strong political hue to the compulsory licensing regimes in those countries, particularly Thailand's. While Brazil efficiently employed these licences as14strategic threats in return for price cuts offered by patent holding companies, the seven licences issued by Thailand's post-coup government are considered extraordinary. It was viewed that an unlawful government was trying to curry favour with the Thai people. The legitimacy of the Thai licences was placed in significant doubt. Given each country's unique characteristics, it is clear that compulsory licensing should not be regarded as a 'one-size-fits-all' solution to combat all healthcare issues in less-developed nations. In addition, this work seeks to achieve a secondary objective of critically evaluating the position of the following multilateral organisations on the issue of compulsory licensing of pharmaceutical products: the EU, WIPO, the WHO, and health-related NGOs. While the EU has built an image as a quiet and tactful player, WIPO displays subtle opposition to compulsory licensing. The WHO attempts to maintain a neutral stance in the ongoing deliberations while the NGOs want to dismantle any barriers to the access to medicines, created by TRIPS.
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.
India and the Patent Wars contributes to an international debate over the costs of medicine and restrictions on access under stringent patent laws showing how activists and drug companies in low-income countries seize agency and exert influence over these processes. Murphy Halliburton contributes to analyses of globalization within the fields of anthropology, sociology, law, and public health by drawing on interviews and ethnographic work with pharmaceutical producers in India and the United States. India has been at the center of emerging controversies around patent rights related to pharmaceutical production and local medical knowledge. Halliburton shows that Big Pharma is not all-powerful, and that local activists and practitioners of ayurveda, India’s largest indigenous medical system, have been able to undermine the aspirations of multinational companies and the WTO. Halliburton traces how key drug prices have gone down, not up, in low-income countries under the new patent regime through partnerships between US- and India-based companies, but warns us to be aware of access to essential medicines in low- and middle-income countries going forward.
The proceedings shed light on selected topics including economic management, public administration, and green development. Featuring scholarly works from the 4th International Conference on Economic Management and Green Development (ICEMGD 2021), this volume of proceedings showcases the papers composed with regard to a diverse range of topics situated at the intersecting field of Economic Management, Public Administration and Green Development. Arising as the top concern of the global community, issues of green development impose challenges for the academia to bridge the interdisciplinary prowess in tackling the gap of knowledge within concerned fields. ICEMGD 2021 is an annual conference initiated by the year of 2017 under the goal of bringing together intellectuals from economics, business management, public administration, and otherwise related spheres for the share of research methods and theoretical breakthroughs. The aim of the proceeding volume is for the integration of social scientific research methods with research into alarming development issues. The ICEMGD 2021 seeks to promote joint initiatives among well-established fields like macro- and microeconomics, international economics, finance, agricultural economics, health economics, business management and marketing strategies, regional development studies, social governance, and sustainable development. Featuring interdisciplinary contributions, this book will be of interest to researchers, academics, professionals and policy makers in the field of economic management, public administration, and development studies.