Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-09-03

Total Pages: 366

ISBN-13: 030922408X

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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.

Respectable Deviance and Purchasing Medicine Online

Respectable Deviance and Purchasing Medicine Online PDF

Author: Lisa Sugiura

Publisher: Springer

Published: 2018-02-13

Total Pages: 180

ISBN-13: 3319744852

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This is a unique interdisciplinary exploration of the contemporary phenomenon of online medicine purchasing. In this research, Sugiura provides a criminological understanding of the sale of online medicines as well as the traditional illegal markets. Crucially, the practice is investigated from the perspective of web users, moving beyond the headlines and warning campaigns to contextualise the provision of medicines online, to describe this practice and subjective accounts of purchasing medicines from the Web. Drawing together established deviance theories, Respectable Deviance and Purchasing Medicine Online considers the construction of online medicine purchasing, the justifications presented to challenge how it is labelled, and how the behaviour is managed to show how the framing of risks and deviance is challenged online. Offering a much-needed a critical overview of the UK healthcare regulatory system, Sugiura also analyses literature, data and policy documents originating from different countries highlighting that the geographical locations of participants in web forums, online surveys and non-face-to-face interviews cannot always be verified. With broad implications for regulation and safety surrounding medicines online, this innovative and timely study contributes to current online healthcare debates and broadens our understanding of cybercrime. It will be of particular interest to scholars of cybercrime and those interested in the changing nature of deviance.

The Politics of the Pharmaceutical Industry and Access to Medicines

The Politics of the Pharmaceutical Industry and Access to Medicines PDF

Author: Hans Löfgren

Publisher: Routledge

Published: 2017-07-06

Total Pages: 222

ISBN-13: 1351470590

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The book studies the pharmaceutical industry of India. It is one of the most successful stories of economic expansion and improvements in public health. Indian firms have made access to quality medicines possible and affordable in many developing countries. Indian pharmaceuticals are also exported on a large scale to the United States and other highly regulated markets. A wave of mergers, acquisitions and tie-ups point to growing integration between Indian firms and global pharma multinationals. Please note: Taylor & Francis does not sell or distribute the Hardback in India, Pakistan, Nepal, Bhutan, Bangladesh and Sri Lanka

Intellectual Property and Public Health in the Developing World

Intellectual Property and Public Health in the Developing World PDF

Author: Monirul Azam

Publisher: Open Book Publishers

Published: 2016-05-30

Total Pages: 193

ISBN-13: 1783742313

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Across the world, developing countries are attempting to balance the international standards of intellectual property concerning pharmaceutical patents against the urgent need for accessible and affordable medicines. In this timely and necessary book, Monirul Azam examines the attempts of several developing countries to walk this fine line. He evaluates the experiences of Brazil, China, India, and South Africa for lessons to guide Bangladesh and developing nations everywhere. Azam's legal expertise, concern for public welfare, and compelling grasp of principal case studies make Intellectual Property and Public Health in the Developing World a definitive work. The developing world is striving to meet the requirements of the World Trade Organization's TRIPS Agreement on intellectual property. This book sets out with lucidity and insight the background of the TRIPS Agreement and its implications for pharmaceutical patents, the consequences for developing countries, and the efforts of certain representative nations to comply with international stipulations while still maintaining local industry and public health. Azam then brings the weight of this research to bear on the particular case of Bangladesh, offering a number of specific policy recommendations for the Bangladeshi government—and for governments the world over. Intellectual Property and Public Health in the Developing World is a must-read for public policy-makers, academics and students, non-governmental organizations, and readers everywhere who are interested in making sure that developing nations meet the health care needs of their people.

Countering the Problem of Falsified and Substandard Drugs

Countering the Problem of Falsified and Substandard Drugs PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2013-06-20

Total Pages: 377

ISBN-13: 0309269393

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The adulteration and fraudulent manufacture of medicines is an old problem, vastly aggravated by modern manufacturing and trade. In the last decade, impotent antimicrobial drugs have compromised the treatment of many deadly diseases in poor countries. More recently, negligent production at a Massachusetts compounding pharmacy sickened hundreds of Americans. While the national drugs regulatory authority (hereafter, the regulatory authority) is responsible for the safety of a country's drug supply, no single country can entirely guarantee this today. The once common use of the term counterfeit to describe any drug that is not what it claims to be is at the heart of the argument. In a narrow, legal sense a counterfeit drug is one that infringes on a registered trademark. The lay meaning is much broader, including any drug made with intentional deceit. Some generic drug companies and civil society groups object to calling bad medicines counterfeit, seeing it as the deliberate conflation of public health and intellectual property concerns. Countering the Problem of Falsified and Substandard Drugs accepts the narrow meaning of counterfeit, and, because the nuances of trademark infringement must be dealt with by courts, case by case, the report does not discuss the problem of counterfeit medicines.

Optimizing Treatment for Children in the Developing World

Optimizing Treatment for Children in the Developing World PDF

Author: Stuart MacLeod

Publisher: Springer

Published: 2015-05-12

Total Pages: 333

ISBN-13: 3319157507

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This book is intended to communicate current best practice in pediatric clinical pharmacology and clinical pharmacy with special consideration of the prevailing circumstances and most pressing needs in developing countries. It also addresses measures that may be taken in countries with emerging economies through organizational and political adjustments to reduce unacceptable levels of morbidity and mortality among children and pregnant women with treatable diseases.

International Economic Law

International Economic Law PDF

Author: Giovanna Adinolfi

Publisher: Springer

Published: 2016-12-29

Total Pages: 296

ISBN-13: 3319446452

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This volume scrutinises the main challenges faced by States in their current international economic relations from an interdisciplinary perspective. It combines legal research with political and economic analysis and favours dialogue among scientific disciplines. Readers are offered a series of in-depth studies on a rich variety of topics: how to reconcile States’ interest to benefit from economic liberalization with their need to pursue social goals (such as the protection of human rights or of the environment); recent developments under WTO law and regional integration processes; international cooperation in the energy sector; national regulatory developments in the banking sector, sovereign wealth funds and investor-State arbitration.

European Union Public Health Policy

European Union Public Health Policy PDF

Author: Scott L. Greer

Publisher: Routledge

Published: 2013-02-11

Total Pages: 266

ISBN-13: 1135130396

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Ranging from influence over world trade laws affecting health to population health issues such as obesity to the use of comparative data to affect policy, the EU’s public health policies are increasingly important, visible, expensive and effective. They also provide an invaluable case study for those who want to understand the growth and impact of the EU as well as how states can affect their populations’ lives and health. European Union Public Health Policy capitalizes on extensive new research, providing an introduction to the topic and indicating new intellectual directions surrounding the topic. An introductory section and extended conclusion explore the meaning of public health, the relationship of EU public health policy to health care policy, and the place of public health in the study of European integration and Europeanization. Focusing on health system transformation, global health governance and population health, the chapters address: Relevant policy issues and EU policies; Effects of the EU policies on practice or outcomes; An explanation of the policy trajectory; Current issues and likely future directions or conflicts. Drawing together an international and multidisciplinary selection of experts, this volume is an important contribution for all those interested in public health policy, EU health policy and EU governance.

Saving Lives, Buying Time

Saving Lives, Buying Time PDF

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2004-09-09

Total Pages: 384

ISBN-13: 0309165938

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For more than 50 years, low-cost antimalarial drugs silently saved millions of lives and cured billions of debilitating infections. Today, however, these drugs no longer work against the deadliest form of malaria that exists throughout the world. Malaria deaths in sub-Saharan Africaâ€"currently just over one million per yearâ€"are rising because of increased resistance to the old, inexpensive drugs. Although effective new drugs called "artemisinins" are available, they are unaffordable for the majority of the affected population, even at a cost of one dollar per course. Saving Lives, Buying Time: Economics of Malaria Drugs in an Age of Resistance examines the history of malaria treatments, provides an overview of the current drug crisis, and offers recommendations on maximizing access to and effectiveness of antimalarial drugs. The book finds that most people in endemic countries will not have access to currently effective combination treatments, which should include an artemisinin, without financing from the global community. Without funding for effective treatment, malaria mortality could double over the next 10 to 20 years and transmission will intensify.