There is a strong argument that people throughout the world have a right to receive the medicines they need in an appropriate, affordable, and timely way. Global Pharmaceutical Policy describes the laws, policies, and customs relating to the development and provision of medicines, identifies their strengths and weakness, and then proposes global solutions for getting things better. Here is a masterpiece written in a clear and elegant style. Together, Dukes and Abbott have experience and insight that are unrivalled. Joe Collier, Emeritus Professor of Medicines Policy, St George s, University of London, UK Pharmaceuticals play a central role in health care throughout the world. The pharmaceutical industry is beset with difficulties as increasing research and development expenditure yields fewer new treatments. Public and private budgets strain under the weight of high prices and limited access. The world s poor see little effort to address diseases prevalent in less affluent societies, while the world s wealthy are overusing prescription drugs, risking their health and wasting resources. As the global economic crisis exacerbates pressure on health care budgets, a new presidential administration in Washington, DC has committed to broad health care reform. These circumstances form the backdrop for this extraordinarily timely examination of the global system for the development, production, distribution and use of medicines. The authors are acknowledged experts in the fields of pharmaceutical law and policy, with many years experience advising governments, multilateral organizations and policy-makers on issues involving innovation, access and use of medicines. Supported by a team of independent scientists, doctors and lawyers, they take an insightful look at the issues surrounding global regulation of the pharmaceutical sector, and offer pragmatic suggestions for reform. This book will be of interest to government policy-makers, members of industry, healthcare professionals, teachers, students and lawyers in the fields of public health, intellectual property and international trade.
Given the provenance, this book was always going to be excellent, but it exceeded my highest expectations. It's one of those rare works that combine true scholarship with great imagination and ends up also a real pleasure to read. the breadth of analysis is remarkable and the modelling for better futures is superb. It's more than a must read book; it is a must heed commentary, a blueprint for better public health that would be perilous to ignore.' - Charles Medawar, Founder Social Audit and author of Power and Dependence: Social Audit on the Safety of Medicines the pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the problems, ranging from false advertising and counterfeiting to corruption, waste and overpricing, with unacceptable pressures on doctors, politicians, patients and the media. Uniquely, the book goes on to present a realistic and worldwide solution for the future, with positive policies encouraging honest dealing as well as partial privatization of enforcement and greater emphasis on creative research to develop the medicines that society needs most.
This edition reflects the evolution of legal standards, professional rules, industrial codes of ethics, and court experience in cases involving recompense for medical injury since the 1988 version. While deriving from legal standards of the US, British Commonwealth, European Union, and Nordic Council, a chapter is devoted to issues particular to developing countries. Following an introductory chapter on the emergence and recognition of problems relating to drug safety, 20 chapters cover such areas as: the legal framework (types of proceedings, evidence, and proof); the responsibility of everyone from the government and manufacturer to the prescriber and patient; clinical investigation of drugs; controlled drugs; self-medication; alternative and complementary medicine; and vaccines and biologicals. Includes a table of cases, and table of conventions, statutes, and regulations. Annotation copyrighted by Book News, Inc., Portland, OR
This edition reflects the evolution of legal standards, professional rules, industrial codes of ethics, and court experience in cases involving recompense for medical injury since the 1988 version. While deriving from legal standards of the US, British Commonwealth, European Union, and Nordic Council, a chapter is devoted to issues particular to developing countries. Following an introductory chapter on the emergence and recognition of problems relating to drug safety, 20 chapters cover such areas as: the legal framework (types of proceedings, evidence, and proof); the responsibility of everyone from the government and manufacturer to the prescriber and patient; clinical investigation of drugs; controlled drugs; self-medication; alternative and complementary medicine; and vaccines and biologicals. Includes a table of cases, and table of conventions, statutes, and regulations. Annotation copyrighted by Book News, Inc., Portland, OR
There is a strong argument that people throughout the world have a right to receive the medicines they need in an appropriate, affordable, and timely way. Global Pharmaceutical Policy describes the laws, policies, and customs relating to the development and provision of medicines, identifies their strengths and weakness, and then proposes global solutions for getting things better. Here is a masterpiece written in a clear and elegant style. Together, Dukes and Abbott have experience and insight that are unrivalled. Joe Collier, Emeritus Professor of Medicines Policy, St George s, University of London, UK Pharmaceuticals play a central role in health care throughout the world. The pharmaceutical industry is beset with difficulties as increasing research and development expenditure yields fewer new treatments. Public and private budgets strain under the weight of high prices and limited access. The world s poor see little effort to address diseases prevalent in less affluent societies, while the world s wealthy are overusing prescription drugs, risking their health and wasting resources. As the global economic crisis exacerbates pressure on health care budgets, a new presidential administration in Washington, DC has committed to broad health care reform. These circumstances form the backdrop for this extraordinarily timely examination of the global system for the development, production, distribution and use of medicines. The authors are acknowledged experts in the fields of pharmaceutical law and policy, with many years experience advising governments, multilateral organizations and policy-makers on issues involving innovation, access and use of medicines. Supported by a team of independent scientists, doctors and lawyers, they take an insightful look at the issues surrounding global regulation of the pharmaceutical sector, and offer pragmatic suggestions for reform. This book will be of interest to government policy-makers, members of industry, healthcare professionals, teachers, students and lawyers in the fields of public health, intellectual property and international trade.
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