Download or read book The Palgrave Handbook of Philosophy and Public Policy written by David Boonin and published by Springer. This book was released on 2018-10-08 with total page 836 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
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 Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
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 Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
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 The Oxford Handbook of the Economics of the Biopharmaceutical Industry written by Patricia M. Danzon and published by Oxford University Press. This book was released on 2012-04-12 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biopharmaceutical industry has been a major driver of technological change in health care, producing unprecedented benefits for patients, cost challenges for payers, and profits for shareholders. As consumers and companies benefit from access to new drugs, policymakers around the globe seek mechanisms to control prices and expenditures commensurate with value. More recently the 1990s productivity boom of new products has turned into a productivity bust, with fewer and more modest innovations, and flat or declining revenues for innovative firms as generics replace their former blockbuster products. This timely volume examines the economics of the biopharmaceutical industry, with eighteen chapters by leading academic health economists. Part one examines the economics of biopharmaceutical innovation including determinants of the costs and returns to new drug development; how capital markets finance R&D and how costs of financing the biopharmaceutical industry compare to financing costs for other industries; the effects of safety and efficacy regulation by the Food and Drug Administration (FDA) and of price and reimbursement regulation on incentives for innovation; and the role of patents and regulatory exclusivities. Part two examines the market for biopharmaceuticals with chapters on prices and reimbursement in the US, the EU, and other industrialized countries, and in developing countries. It looks at the optimal design of insurance for drugs and the effects of cost sharing on spending and on health outcomes; how to measure the value of pharmaceuticals using pharmacoeconomics, including theory, practical challenges, and policy issues; how to measure pharmaceutical price growth over time and recent evidence; empirical evidence on the value of pharmaceuticals in terms of health outcomes; promotion of pharmaceuticals to physicians and consumers; the economics of vaccines; and a review of the evidence on effects of mergers, acquisitions and alliances. Each chapter summarizes the latest insights from theory and recent empirical evidence, and outlines important unanswered questions and areas for future research. Based on solid economics, it is nevertheless written in terms accessible to the general reader. The book is thus recommended reading for academic economists and non-economists, and for those in industry and policy who wish to understand the economics of this fascinating industry.
Download or read book How Increased Competition from Generic Drugs Has Affected Prices and Returns in the Pharmaceutical Industry written by and published by U.S. Government Printing Office. This book was released on 1998 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt:
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 Generic Drug Entry Prior to Patent Expiration written by United States. Federal Trade Commission and published by William s Hein & Company. This book was released on 2002-01-01 with total page 113 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In April 2001, the Commission began an industry-wide study focused on certain aspects of generic drug competition under the Hatch-Waxman Amendments. The Amendments provide certain methods by which generic drug manufacturers can obtain approval to market a generic version of a brand-name product. The study's purpose was to provide a more complete picture of how generic drug competition has developed under one method the Amendments established: generic entry prior to expiration of the brand-name company's patents on the relevant drug product. This report sets forth the results of the study. The study was prompted, in part, by the Commission's enforcement actions against alleged anticompetitive agreements that relied on certain Hatch-Waxman provisions. The study was designed to determine whether such agreements are isolated instances or more typical, and whether particular provisions of the Hatch-Waxman Amendments are susceptible to strategies to delay or deter consumer access to low-cost generic alternatives to brand-name drug products." -- from the Introduction, p. 1.
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 Research and Development in the Pharmaceutical Industry A CBO Study written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...
Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today's challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. - Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations - Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference - Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
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 Safe and Effective Medicines for Children written by Institute of Medicine and published by National Academies Press. This book was released on 2012-10-13 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.
Download or read book Drug Wars written by Robin Feldman and published by Cambridge University Press. This book was released on 2017-06-09 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
