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Author: John C. Todaro Publisher: Kluwer Law International B.V. ISBN: 9403501367 Category : Law Languages : en Pages : 250
Book Description
Data exclusivity gives pharmaceutical companies a limited period of time in which clinical test data are exclusive to the innovator. Internationally, however, aside from prohibition against unfair commercial use, there are no specifics as to how these data are protected; exclusivity is available on a jurisdiction-by-jurisdiction basis. This book, the only one of its kind, provides expert guidance, chapter by chapter, on test data exclusivity rights for pharmaceutical products in twenty-two major markets worldwide. For each jurisdiction, in addition to explaining the available regulatory data protection – including both substantive and formal requirements for approvals and testing, protection of undisclosed data, confidentiality, and enforcement in practice – local experts provide detailed information and guidance on the degree to which test data exclusivity may be achieved in such areas of pharmaceutical research as the following: infectious disease products; paediatrics products; chemical and biological products; agricultural products; animal health products; orphan drugs; and new chemical entities. This book originated from a project conducted by the Pharma Committee of the International Association for the Protection of Intellectual Property (AIPPI), the world’s leading non-profit association dedicated to the development, expansion, and improvement of international and regional treaties and agreements and national laws relating to intellectual property. Many committee members and observers are authors of chapters in this book. An unmatched starting point for innovator pharmaceutical companies and their advisers to evaluate data exclusivity rules and opportunities around the world, this book will be an invaluable resource for IP professionals, governments, non-governmental organizations, and international organizations to promote and share IP laws and practices.
Author: John C. Todaro Publisher: Kluwer Law International B.V. ISBN: 9403501367 Category : Law Languages : en Pages : 250
Book Description
Data exclusivity gives pharmaceutical companies a limited period of time in which clinical test data are exclusive to the innovator. Internationally, however, aside from prohibition against unfair commercial use, there are no specifics as to how these data are protected; exclusivity is available on a jurisdiction-by-jurisdiction basis. This book, the only one of its kind, provides expert guidance, chapter by chapter, on test data exclusivity rights for pharmaceutical products in twenty-two major markets worldwide. For each jurisdiction, in addition to explaining the available regulatory data protection – including both substantive and formal requirements for approvals and testing, protection of undisclosed data, confidentiality, and enforcement in practice – local experts provide detailed information and guidance on the degree to which test data exclusivity may be achieved in such areas of pharmaceutical research as the following: infectious disease products; paediatrics products; chemical and biological products; agricultural products; animal health products; orphan drugs; and new chemical entities. This book originated from a project conducted by the Pharma Committee of the International Association for the Protection of Intellectual Property (AIPPI), the world’s leading non-profit association dedicated to the development, expansion, and improvement of international and regional treaties and agreements and national laws relating to intellectual property. Many committee members and observers are authors of chapters in this book. An unmatched starting point for innovator pharmaceutical companies and their advisers to evaluate data exclusivity rules and opportunities around the world, this book will be an invaluable resource for IP professionals, governments, non-governmental organizations, and international organizations to promote and share IP laws and practices.
Author: Owais H. Shaikh Publisher: Springer ISBN: 3662496550 Category : Law Languages : en Pages : 269
Book Description
This book explores the concept of test data exclusivity protection for pharmaceuticals. Focusing on Art 39(3) of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and relevant provisions in selected free trade agreements (FTA) and national laws, it combines normative, historical, comparative and economic analysis of test data exclusivity protection.At the heart of this book is the novel and original Index of Data Exclusivity and Access (IDEAS), which analyzes the effectiveness of test data exclusivity provisions in FTAs and national laws both on the strength of exclusivity as well as on access to medicine. IDEAS provides a framework for the assessment of current test data exclusivity protection standards on the basis of their proximity to Article 39(3) of the TRIPS Agreement, the scope of exclusivity and the flexibilities in FTAs, and subsequently in national laws. This book aims to broaden national and international policy makers’ grasp of the various nuances of test data exclusivity protection. Furthermore, it provides practical recommendations with regard to designing an appropriate legal system with a strong focus on promoting access to medicine for all.
Author: David Boonin Publisher: Springer ISBN: 3319939076 Category : Philosophy Languages : en Pages : 836
Book Description
This book brings together a large and diverse collection of philosophical papers addressing a wide variety of public policy issues. Topics covered range from long-standing subjects of debate such as abortion, punishment, and freedom of expression, to more recent controversies such as those over gene editing, military drones, and statues honoring Confederate soldiers. Part I focuses on the criminal justice system, including issues that arise before, during, and after criminal trials. Part II covers matters of national defense and sovereignty, including chapters on military ethics, terrorism, and immigration. Part III, which explores political participation, manipulation, and standing, includes discussions of issues involving voting rights, the use of nudges, and claims of equal status. Part IV covers a variety of issues involving freedom of speech and expression. Part V deals with questions of justice and inequality. Part VI considers topics involving bioethics and biotechnology. Part VII is devoted to beginning of life issues, such as cloning and surrogacy, and end of life issues, such as assisted suicide and organ procurement. Part VIII navigates emerging environmental issues, including treatments of the urban environment and extraterrestrial environments.
Author: Adam Buick Publisher: Springer Nature ISBN: 303129436X Category : Law Languages : en Pages : 236
Book Description
This book considers the intellectual property protection of clinical test data that has been submitted to governments, in particular through test data exclusivity rights. It focuses on how these intellectual property rights first emerged in the early 1980s, how they have globalised over the past four decades, and what impact they have had upon access to medicine. This book makes a number of significant and original contributions to the literature around the protection of submitted test data. First, the book draws upon the theory of regulatory globalisation to provide an explanation of how intellectual property rights in submitted pharmaceutical test data have become nearly ubiquitous in the legal systems of most major economies. Second, through a comprehensive analysis and synthesis of provisions on the protection of submitted test data in free trade agreements, as well as a comparison of a range of national approaches to the protection of submitted test data, it reveals the broader global regulatory pattern that has given rise to these intellectual property rights. Third, by analysing data on drug approvals in the US, it provides an empirical insight into the impact of test data exclusivity in national pharmaceutical markets. Fourth, the book covers a number of developments regarding test data exclusivity that have occurred as a result of responses to the COVID-19 pandemic, both at the national level as well as at the World Trade Organisation (WTO). This book will appeal to academics researching the intersection of intellectual property and the life sciences, civil society activists working to promote access to medicines, and students (particularly those at the post-graduate level) studying the relationship between intellectual property and medicine.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309316324 Category : Medical Languages : en Pages : 236
Book Description
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.
Author: Ellen F. M. 't Hoen Publisher: ISBN: 9789079700851 Category : Languages : en Pages : 181
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.
Author: Divya Vohora Publisher: Academic Press ISBN: 0128020989 Category : Medical Languages : en Pages : 527
Book Description
Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
Author: Lina Perez Publisher: ISBN: Category : Languages : en Pages : 0
Book Description
Developing countries have widely adopted data exclusivity for pharmaceutical test data protection although this is not mandated by TRIPS. Moreover at the bilateral level, developed countries have pushed towards stringent IP packages, among them, data exclusivity. The dissertation explores the challenges of data exclusivity in developing countries and argues that the alleged benefits of innovation and dissemination of technology do not exceed the social costs this IP regime poses. Therefore, the research goes on to examine legal alternatives in compliance with Article 39.3, TRIPS, and suggest other legal frameworks for pharmaceutical test data protection. The study finds that developing countries have underestimated TRIPS flexibilities and have ignored safeguard measures for addressing their public health concerns. The discussion concludes that developing countries are in strong legal position to persuade changes on this field and argues for implementing measures according to the country ́s level of development.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309158060 Category : Medical Languages : en Pages : 442
Book Description
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author: John C. Todaro
Author: John C. Todaro
Author: Owais H. Shaikh
Author: David Boonin
Author: Adam Buick
Author: Institute of Medicine
Author: Ellen F. M. 't Hoen
Author: Divya Vohora
Author: Lina Perez
Author: 
Author: Institute of Medicine