Product Liability And The Economics Of Pharmaceuticals And Medical Devices
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Product Liability and the Economics of Pharmaceuticals and Medical Devices by Steven Garber Pdf
This study examined the economic effects of product liability on firms producing drugs and medical devices. The study found that the liability system enhances the economic contributions of the industries in some ways.
Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals by Steven Garber Pdf
Liability effects on the economic performance of the pharmaceutical industry play a prominent role in the debate about the economic effects of product liability in the United States. The author analyzes incentive effects on company decisions, implications for economic outcomes such as drug safety and effectiveness, and suggests how public policy changes could mitigate liability-based sources of inefficient decisions of pharmaceutical companies.
Innovation and the Pharmaceutical Industry by H. Tristram Engelhardt Pdf
Innovation and the Pharmaceutical Industry: Critical Reflections on the Virtues of Profit examines the central role of profit in the development of pharmaceuticals, medical devices, and health care generally. Recent efforts to understand this role have often underestimated and even dismissed its importance, arguing for its replacement by other means and mechanisms. However, as the essays in this volume attest, it would be impossible to account adequately for the range of pharmaceuticals and medical devices that have become part of everyday medicine without recognizing that the depth and scope of innovations are tied not simply to altruism, a concern for the common good, or the pursuit of knowledge for its own sake, but crucially to the pursuit of private good and of individual profit. Balancing a concern for theory and practice, the analyses and evaluations provided in these essays touch directly on many of the most heated and important debates in pharmaceutical ethics, such as profit margins, corporate social responsibility, drug advertising, litigation, patents, and parallel trade. Reflecting critically on the problems and prospects of medical innovation, they invite a rethinking of the foundations of the bioethics and business ethics of the pharmaceutical and medical device industries by focusing on the long-term impact of policy decisions for human health and well-being.
Pharmaceutical and Medical Device Safety by Sonia Macleod,Sweta Chakraborty Pdf
"This book examines how regulatory and liability mechanisms have impacted upon product safety decisions in the pharmaceutical and medical devices sectors in Europe, the USA and beyond since the 1950s. Thirty-five case studies illustrate the interplay between the regulatory regimes and litigation. Observations from medical practice have been the overwhelming means of identifying post-marketing safety issues. Drug and device safety decisions have increasingly been taken by public regulators and companies within the framework of the comprehensive regulatory structure that has developed since the 1960s. In general, product liability cases have not identified or defined safety issues, and function merely as compensation mechanisms. This is unsurprising as the thresholds for these two systems differ considerably; regulatory action can be triggered by the possibility that a product might be harmful, whereas establishing liability in litigation requires proving that the product was actually harmful. As litigation normally post-dates regulatory implementation, the 'private enforcement' of public law has generally not occurred in these sectors. This has profound implications for the design of sectoral regulatory and liability regimes, including associated features such as extended liability law, class actions and contingency fees. This book forms a major contribution to the academic debate on the comparative utility of regulatory and liability systems, on public versus private enforcement, and on mechanisms of behaviour control."--Bloomsbury Publishing.
Institute of Medicine,Committee on Technological Innovation in Medicine
Author : Institute of Medicine,Committee on Technological Innovation in Medicine Publisher : National Academies Press Page : 225 pages File Size : 41,7 Mb Release : 1991-02-01 Category : Medical ISBN : 9780309044912
The Changing Economics of Medical Technology by Institute of Medicine,Committee on Technological Innovation in Medicine Pdf
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Consumer Protection, and Competitiveness
Author : United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Consumer Protection, and Competitiveness Publisher : Unknown Page : 510 pages File Size : 42,6 Mb Release : 1994 Category : Business & Economics ISBN : UCR:31210011562327
Product Liability Standards by United States. Congress. House. Committee on Energy and Commerce. Subcommittee on Commerce, Consumer Protection, and Competitiveness Pdf
Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals by Steven Garber Pdf
Liability effects on the economic performance of the pharmaceutical industry play a prominent role in the debate about the economic effects of product liability in the United States. The author analyzes incentive effects on company decisions, implications for economic outcomes such as drug safety and effectiveness, and suggests how public policy changes could mitigate liability-based sources of inefficient decisions of pharmaceutical companies.
Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries
Author : Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries Publisher : National Academies Press Page : 366 pages File Size : 55,5 Mb Release : 2012-09-03 Category : Medical ISBN : 9780309224086
Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad by Institute of Medicine,Board on Health Sciences Policy,Board on Global Health,Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries Pdf
A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness. The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.
Institute of Medicine,National Academy of Engineering
Author : Institute of Medicine,National Academy of Engineering Publisher : National Academies Press Page : 203 pages File Size : 44,6 Mb Release : 1988-01-01 Category : Medical ISBN : 9780309038478
New Medical Devices by Institute of Medicine,National Academy of Engineering Pdf
In the past 50 years the development of a wide range of medical devices has improved the quality of people's lives and revolutionized the prevention and treatment of disease, but it also has contributed to the high cost of health care. Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the decision-making process behind private funding, the need for reforms in regulation and product liability, the effects of the medical payment system, and other critical topics relevant to the development of new devices.
United States. General Accounting Office,United States. Congress. House. Committee on Ways and Means
Author : United States. General Accounting Office,United States. Congress. House. Committee on Ways and Means Publisher : Unknown Page : 32 pages File Size : 41,8 Mb Release : 1995 Category : Hospitals ISBN : UOM:39015048860954
This is the first volume of an exciting new series, Current Legal Issues, which will be published each spring as a sister volume to Current Legal Problems. This book is the first volume in the series and explores the relationship of law and science, with a particular focus on the role of science as evidence.
Medicinal Product Liability and Regulation by Richard Goldberg Pdf
The piecemeal developments in product liability reform in Europe have their origins in the tragic association of phocomelia in children with thalidomide in 1962. In many ways these events have continued to generate pressure for reform of product liability, especially for the victims of drug-induced injury. This monograph attempts to address the major problems that typify claims for drug-induced injury, as well as highlighting the complex interrelationship between liability exposure and drug regulation. While medicinal products are subject to strict liability under the product liability directive, the claimant may have considerable difficulty in establishing that the relevant product is defective and that it caused the damage. It may also be necessary to overcome the development risk defence where this is pleaded. The monograph addresses these problems on a comparative jurisprudential basis, and seeks to determine whether medicinal products should be treated as a special case in the field of product liability. It examines the role of epidemiological evidence in assessing causation in product liability cases concerning medicinal products in the light of recent developments in the UK Supreme Court, the United States, Canada and France. In particular, it addresses the difficulties in reconciling the standards of proof in law and science, including the theory that causation can be proved on the balance of probabilities by reference to the doubling of risk of injury. An important case study compares and contrasts the approaches of the UK and the US to the measles, mumps, rubella Litigation. The book also examines the question as to whether compliance with regulatory standards should protect pharmaceutical manufacturers from product liability suits. It seeks to support a via media whereby the victims of drug induced injury can receive justice, while at the same time encouraging drug safety and innovation in drug development.
Handbook of Law and Economics by A. Mitchell Polinsky,Steven Shavell Pdf
Law can be viewed as a body of rules and legal sanctions that channel behavior in socially desirable directions — for example, by encouraging individuals to take proper precautions to prevent accidents or by discouraging competitors from colluding to raise prices. The incentives created by the legal system are thus a natural subject of study by economists. Moreover, given the importance of law to the welfare of societies, the economic analysis of law merits prominent treatment as a subdiscipline of economics. Our hope is that this two volume Handbook will foster the study of the legal system by economists. *The two volumes form a comprehensive and accessible survey of the current state of the field.*Chapters prepared by leading specialists of the area.*Summarizes received results as well as new developments.
