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.
The Price of Global Health is the first book of its kind: an in-depth but straightforward exploration of the pharmaceutical pricing strategy process, its underlying market access, general business and ethical considerations, and its implications for payers, physicians and patients. It is a much needed and invaluable resource for anybody interested, involved in or affected by the development, funding and use of prescription drugs. In particular, it is of critical importance to pharmaceutical company executives and other leaders and professionals in commercialization and drug development, including marketing, business development, market access and pricing, clinical development, drug discovery, regulatory affairs, health outcomes, market research and public affairs.
Eating the flesh of an Egyptian mummy prevents the plague. Distilled poppies reduce melancholy. A Turkish drink called coffee increases alertness. Tobacco cures cancer. Such beliefs circulated in the seventeenth and eighteenth centuries, an era when the term "drug" encompassed everything from herbs and spices—like nutmeg, cinnamon, and chamomile—to such deadly poisons as lead, mercury, and arsenic. In The Age of Intoxication, Benjamin Breen offers a window into a time when drugs were not yet separated into categories—illicit and licit, recreational and medicinal, modern and traditional—and there was no barrier between the drug dealer and the pharmacist. Focusing on the Portuguese colonies in Brazil and Angola and on the imperial capital of Lisbon, Breen examines the process by which novel drugs were located, commodified, and consumed. He then turns his attention to the British Empire, arguing that it owed much of its success in this period to its usurpation of the Portuguese drug networks. From the sickly sweet tobacco that helped finance the Atlantic slave trade to the cannabis that an East Indies merchant sold to the natural philosopher Robert Hooke in one of the earliest European coffeehouses, Breen shows how drugs have been entangled with science and empire from the very beginning. Featuring numerous illuminating anecdotes and a cast of characters that includes merchants, slaves, shamans, prophets, inquisitors, and alchemists, The Age of Intoxication rethinks a history of drugs and the early drug trade that has too often been framed as opposites—between medicinal and recreational, legal and illegal, good and evil. Breen argues that, in order to guide drug policy toward a fairer and more informed course, we first need to understand who and what set the global drug trade in motion.
Andrew Lakoff argues that a new 'pharmaceutical' way of thinking about and acting upon mental disorder is coming to reshape not only the field of psychiatry, but also our very notions of self. Drawing from a comprehensive ethnography of psychiatric practice in Argentina (a country which boasts the most psychoanalysts per capita in the world) Lakoff looks at new ways of understanding and intervening in human behaviour. He charts the globalization of pharmacology, particularily the global impact of US psychiatry and US models of illness, and further illustrates the clashes, conflicts, alliances and reformulations that take place when psychoanalytic and psychopharmacological models of illness and cure meet. Highlighting the social and political implications that these new forms of expertise about human behaviour and human thought bring, Lakoff presents an arresting case-study that will appeal to scholars and students alike.
The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.
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.
The pharmaceutical industry, long thought of as a recession-proof investment, now faces a day of reckoning. The reasons for this impending downfall are not hard to discern. The prices the industry charges for its prescription drugs have escalated at four to five times the cost-of-living increases during the past two decades and have reached a point where 30% of Americans must choose between filling a prescription, paying for housing, and buying food. This has brought about public pressure on governments around the world to control drug prices, yet the world’s twenty largest pharma companies realized 80% of their growth as a result of exorbitant price hikes. Pharma currently enjoys its extraordinary profitability by exploiting the world’s most vulnerable populations. Yet even their ability to increase prices in the face of falling demand does not satisfy their profit demands. The breadth and depth of pharma’s marketing transgressions exceed those of any other industry and have now reached a point where authorities around the world have found it necessary to take legal action against its violations. Drastic change is needed if the pharmaceutical industry can equitably advance the health of the world’s population and regain public esteem. This book illustrates the range and extent of pharma’s violations and addresses the actions that should be implemented in order to make the drug industry a more constructive, less venal part of contemporary society. It will be of interest to researchers, academics, practitioners, and students with an interest in the pharmaceutical industry, healthcare management, regulation, and bioethics.
This book provides an overview of the global pharmaceutical pricing policies. Medicines use is increasing globally with the increase in resistant microbes, emergence of new treatments, and because of awareness among consumers. This has resulted in increased drug expenditures globally. As the pharmaceutical market is expanding, a variety of pharmaceutical pricing strategies and policies have been employed by drug companies, state organizations and pharmaceutical pricing authorities.