DIVAnthropological study of the globalization of pharmaceuticals and its effects on local cultures, health, and economics./div

Medicines are vital in improving patient health outcomes and pharmaceutical policy is a fundamental component of any health system. However, the global pharmaceutical policy is ever-evolving and data and quality ‘research-based information’ in this field are scarce. This book fills this gap and provides up-to-date empirical information and evidence-based synthesis. It focuses on pertinent key issues in global pharmaceutical policy including medicines safety, generic medicines, pharmaceutical supply chain, medicines financing, access and affordability of medicines, rational use of medicines, pharmacy health services research and access to vaccines and biological products. Featuring policy case studies from varied countries such as Mexico, Russia, China, Kyrgyzstan, and Pakistan, this book comprises a valuable and comprehensive resource for students, funders, policymakers, academics, and researchers interested in this field.

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.

Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

Continuing his pioneering theoretical explorations into the relationships among biosciences, the market, and political economy, Kaushik Sunder Rajan introduces the concept of pharmocracy to explain the structure and operation of the global hegemony of the multinational pharmaceutical industry. He reveals pharmocracy's logic in two case studies from contemporary India: the controversial introduction of an HPV vaccine in 2010, and the Indian Patent Office's denial of a patent for an anticancer drug in 2006 and ensuing legal battles. In each instance health was appropriated by capital and transformed from an embodied state of well-being into an abstract category made subject to capital's interests. These cases demonstrate the precarious situation in which pharmocracy places democracy, as India's accommodation of global pharmaceutical regulatory frameworks pits the interests of its citizens against those of international capital. Sunder Rajan's insights into this dynamic make clear the high stakes of pharmocracy's intersection with health, politics, and democracy.

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.

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.

Global Perspectives on Astaxanthin: From Industrial Production to Food, Health, and Pharmaceutical Applications explores the range of practical applications for this molecule, focusing on nutraceutical, pharmaceutical and cosmeceutical products, along with food and feed. This volume brings together the most relevant research, background and future thinking on astaxanthin, focusing on its health benefits. Chapters cover phytopharmaceuticals, industrial production, feeds, downstream processing, regulations, products, color, pigment, cosmetics, bioactive compounds, relationships to other carotenoids, and skin care. The detailed information on its production, processing, utilization and future applications will be of particular use to academic and industry researchers in pharmaceutical sciences, pharmacology and nutrition. - Provides detailed information on astaxanthin, including its production, processing, utilization and future applications - Includes discussion on the commercial analysis procedure - Offers critical analysis on current and potential applications of astaxanthin as contributed by 121 authors from 22 countries in academia, research institutes and industries