Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Download or read book The Global Politics of Pharmaceutical Monopoly Power written by Ellen F. M. 't Hoen and published by . This book was released on 2009 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Negotiating Health written by Pedro Roffe and published by Earthscan. This book was released on 2012 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: In developing countries, access to affordable medicines for the treatment of diseases such as AIDS and malaria remains a matter of life or death. In Africa, for instance, more than one million children die each year from malaria alone, a figure which could soon be far higher with the extension of patent rules for pharmaceuticals. Previously, access to essential medicines was made possible by the supply of much cheaper generics, manufactured largely by India; from 2005, however, the availability of these drugs is threatened as new WTO rules take effect. Halting the spread of malaria and HIV/AIDS is one of the eight Millennium Goals adopted at the UN Millennium Summit, which makes this a timely and topical book.Informed analysis is provided by internationally renowned contributors who look at the post-2005 world and discuss how action may be taken to ensure that intellectual property regimes are interpreted and implemented in a manner supportive to the right to protect public health and, in particular, to promote access to medicines for all.
Download or read book Private Patents and Public Health written by Ellen F. M. 't Hoen and published by . This book was released on 2016 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Download or read book Pharmaceutical Medicine Biotechnology and European Law written by Richard Goldberg and published by Cambridge University Press. This book was released on 2000 with total page 279 pages. Available in PDF, EPUB and Kindle. Book excerpt: Lawyers and academics reassess the impact of European law on health care and pharmaceutical law.
Download or read book Patent Rights in Pharmaceuticals in Developing Countries written by Jakkrit Kuanpoth and published by Edward Elgar Publishing. This book was released on 2010-01-01 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Vaccines Medicines and COVID 19 written by Germán Velásquez and published by Springer Nature. This book was released on 2022-01-01 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Protection of Regulatory Data Under Article 39 3 of TRIPS written by Shammad Basheer and published by . This book was released on 2006-01-01 with total page 22 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Intellectual Property Biogenetic Resources and Traditional Knowledge written by Graham Dutfield and published by Routledge. This book was released on 2010-09-23 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biogenetic resources - the critical biological and chemical materials that underpin so much of medicine, both modern and traditional, agriculture, and wider economic activity in so many fields - are at the centre of heated debate regarding their use, development, and ownership, and the issues of ethics and equity that impinge on all of these factors. This book is a comprehensive examination of the key issues, institutions and ideologies in this area, presenting definitions and explanations of the fundamentals of intellectual property rights (IPRs), biogenetic resources and traditional knowledge. It uses the insights from this to build a picture of how these factors interact in practice, bringing to the surface issues such as: the conservation and sustainable use of biodiversity, benefit sharing from the commercial use of biodiversity, biotechnological innovation and the transfer of technology, agriculture, food security, rural development, health and international justice. Part 1 describes the relevant international IPR laws, highlights the extent to which modern commerce depends on such resources, and traces the way in which modern IPR law has evolved to accommodate this dependence. Part 2 shows how stronger IPR protection in the area of life science innovation has given rise to controversies such as 'biopiracy', 'terminator' genes and genetic uniformity. Part 3 focuses on traditional knowledge, its nature, its importance, and the applicability of IPR-style protection. Part 4 covers the international negotiation and policy-making of the WTO, WIPO and CBD and the legislative initiatives of national governments of Asia, Africa and Latin America. Finally, Part 5 focuses on two developing country case studies - of India and Kenya - assessing whether they will be able to gain economic benefit from development of their natural resources within the current regulatory system and whether this will encourage the conservation and sustainable use of the resource base. With its multidisciplinary approach and breadth of coverage, this book will appeal both to those new to the subject and to those with professional and specialist interest, including students, academics, legal practitioners, government policy-makers and the private sector.
Download or read book Resource Book on TRIPS and Development written by Unctad-ictsd and published by . This book was released on 2005 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: NAture of obligations, principles and objectives; Substantive obligations; Intellectual property rights and competition; Enforcemente, maintenance and acquisition of rights; Interpretation and dispute settlement and prevention; Transitional and institutional arragements.
Download or read book Intellectual Property Rights and International Trade written by Shayerah Ilias and published by Nova Publishers. This book was released on 2008 with total page 84 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction -- Intellectual property rights basics -- Global intellectual property holdings -- Contribution of intellectual property to U.S. economy -- The organized structure of IPR protection -- U.S. trade law -- Issues for Congress.
Download or read book Pharmaceutical Patent Protection and World Trade Law written by Jae Sundaram and published by Routledge. This book was released on 2018-05-08 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patents, including pharmaceutical patents, enjoy extended protection for twenty years under the TRIPs Agreement. The Agreement has resulted in creating a two-tier system of the World Trade Organisation Member States, and its implementation has seen the price of pharmaceutical products skyrocket, putting essential medicines beyond the reach of the common man. The hardest hit populations come from the developing and least developed countries, which have either a weak healthcare system or no healthcare at all, where access to essential and affordable medicines is extremely difficult to achieve. Pharmaceutical Patent Protection and World Trade Law studies the problems faced by these countries in obtaining access to affordable medicines for their citizens in light of the TRIPS Agreement. It explores the opportunities that are still open for some developing countries to utilise the flexibilities available under the TRIPS Agreement in order to mitigate the damage caused by it. The book also examines the interrelationship between the world governing bodies, and the right to health contained in some of the developing country’s national constitutions.
Download or read book Intellectual Property and Development written by Keith E. Maskus and published by World Bank Publications. This book was released on 2005-01-01 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: International policies toward protecting intellectual property rights have seen profound changes over the past two decades. Rules on how to protect patents, copyright, trademarks and other forms of intellectual property have become a standard component of international trade agreements. Most significantly, during the Uruguay Round of multilateral trade negotiations (1986-94), members of what is today the World Trade Organization (WTO) concluded the Agreement on Trade Related Intellectual Property Rights (TRIPS), which sets out minimum standards of protection that most of the world's economies have to respect. How will developing countries fare in this new international environment? Intellectual Property and Development brings together empirical research that assesses the effects of changing intellectual property regimes on various measures of economic and social performance - ranging from international trade, foreign investment and competition, to innovation and access to new technologies. The studies presented point to an important development dimension to the protection of intellectual property. But a one-size fits all approach to intellectual property is unlikely to work. There is need to adjust intellectual property norms to domestic needs, taking into account developing countries' capacity to innovate, technological needs, and institutional capabilities. In addition, governments need to consider a range of complementary policies to maximize the benefits and reduce the costs of reformed intellectual property regulations. This book will be of interest to students and scholars of international law, particularly in the area of intellectual property rights, international trade, and public policy.
Download or read book Intellectual Property and Public Health in the Developing World written by Monirul Azam and published by Open Book Publishers. This book was released on 2016-05-30 with total page 193 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Access to Medicine in the Global Economy written by Cynthia Ho and published by Oxford University Press, USA. This book was released on 2011-04-21 with total page 429 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Intellectual Property and International Trade The TRIPS Agreement written by Carlos M. Correa and published by Kluwer Law International B.V.. This book was released on 2016-06-27 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is the most far-reaching and comprehensive legal regime ever concluded at the multilateral level in the area of intellectual property rights (IPR). Compared to prior IPR conventions, TRIPS constitutes a major qualitative leap which radically modifies not only the context in which IPR are considered internationally, but also their substantive content and the methods for their enforcement and dispute settlement. This much-welcomed treatise, now in its third edition, thoroughly updates its comprehensive analysis of the substantive provisions of the Agreement and their actual interpretation and application in different jurisdictions, with new material on the burgeoning case law and on major changes in plant variety protection. As in previous editions, the book may be relied upon for in-depth clarification of such matters as the following: • standards established under the agreement; • enforcement measures; • social and legal issues; • legal and policy possibilities offered; • legislative latitude allowed to WTO Member States; • incorporation of TRIPS into domestic law; • protection of integrated circuit design; • protection of innovation and R&D for diseases that disproportionately affect developing countries; • challenges raised by ongoing technological changes; • access to medicines; • protection of confidential (undisclosed) information; and • interface between competition law and intellectual property protection. With fifteen chapters contributed by a distinguished panel of experts representing diverse parties — international organisations, legal practice, government policy, and academia — the third edition offers an incomparable framework for understanding the background, principles, and complex provisions of the TRIPS Agreement. Thoroughly revised and updated, the third edition will be of great value to all professionals and business people concerned with international trade. It stimulates further discussion and analysis in this area of growing importance to international law and international economic relations, particularly regarding the possibilities offered by the Agreement and the loose ends that may need consideration in the future at the national or international level.
