Poor Quality Pharmaceuticals In Global Public Health

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Poor Quality Pharmaceuticals in Global Public Health

Author : Satoru Kimura,Yasuhide Nakamura
Publisher : Springer Nature
Page : 233 pages
File Size : 55,9 Mb
Release : 2020-01-16
Category : Medical
ISBN : 9789811520891

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Poor Quality Pharmaceuticals in Global Public Health by Satoru Kimura,Yasuhide Nakamura Pdf

This book aims to clarify the global aspects of poor quality pharmaceuticals, generic products in particular, becoming complicated through the process of IMPACT (International Medical Products Anti-Counterfeiting Taskforce) organized by the initiative of the World Health Organization (WHO) in 2006. The findings from this book provide a long-term perspective to policymakers. This book discusses from the following points: industrial standardization, healthcare market accessibility, motivation on supply side, WHO medicines policy and intellectual property rights. Standardization regulates the quality and enabled the generic medicines spreading to developing/emerging countries through technology transfer. However, quality is a part of cost and reflected to price. When a healthcare service market is divided according to wealth gap, compliance to standardization for quality on supply side is divided accordingly. Thus, poor quality pharmaceuticals are prevalent worldwide. Generic pharmaceuticals are essential resources in public health. The WHO has been involved in the dispute around the intellectual property rights under its intention to promote the new drug development for neglected diseases. Global pandemic of AIDs is a critical factor to accelerate the confusion. This created feelings of distrust among developing/emerging countries against developed countries if the WHO was in favour of developed countries. In addition to that, an easy and optimistic start of IMPACT stirred up conflicts of interests in the international community. The problem of poor quality pharmaceuticals became more complicated through the conflicts on intellectual property rights; patented drugs to generic drugs. A key for quality generic products is the formation of a single healthcare service market where good motivation on supply side together with fair competitiveness with patented pharmaceuticals and equitable access to services (both for the rich and the poor) are ensured. Political commitment to investment and regulatory infrastructure for the market is crucial.

Countering the Problem of Falsified and Substandard Drugs

Author : Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products
Publisher : National Academies Press
Page : 377 pages
File Size : 50,8 Mb
Release : 2013-06-20
Category : Medical
ISBN : 9780309269391

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Countering the Problem of Falsified and Substandard Drugs by Institute of Medicine,Board on Global Health,Committee on Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products Pdf

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.

Bitter Pills

Author : Muhammad Hamid Zaman,Muhammad H. Zaman
Publisher : Oxford University Press
Page : 281 pages
File Size : 51,9 Mb
Release : 2018
Category : Medical
ISBN : 9780190219444

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Bitter Pills by Muhammad Hamid Zaman,Muhammad H. Zaman Pdf

Cities in crisis -- The life of a pill -- An age-old problem -- Of mice and cats -- Unaware, unable or unwilling? -- Crime and punishment -- Trust and mistrust -- The disconnected citizens -- The technological fix? -- The ivory trade

Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

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 : 49,8 Mb
Release : 2012-09-03
Category : Medical
ISBN : 9780309224086

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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.

Saving Lives, Buying Time

Author : Institute of Medicine,Board on Global Health,Committee on the Economics of Antimalarial Drugs
Publisher : National Academies Press
Page : 384 pages
File Size : 44,6 Mb
Release : 2004-09-09
Category : Medical
ISBN : 9780309165938

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Saving Lives, Buying Time by Institute of Medicine,Board on Global Health,Committee on the Economics of Antimalarial Drugs Pdf

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.

Selling Sickness

Author : Ray Moynihan,Alan Cassels
Publisher : Greystone Books
Page : 272 pages
File Size : 43,7 Mb
Release : 2008-09-01
Category : Health & Fitness
ISBN : 9781926706689

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Selling Sickness by Ray Moynihan,Alan Cassels Pdf

In this hard-hitting indictment of the pharmaceutical industry, Ray Moynihan and Allan Cassels show how drug companies are systematically using their dominating influence in the world of medical science, drug companies are working to widen the very boundaries that define illness. Mild problems are redefined as serious illness, and common complaints are labeled as medical conditions requiring drug treatments. Runny noses are now allergic rhinitis, PMS has become a psychiatric disorder, and hyperactive children have ADD. Selling Sickness reveals how expanding the boundaries of illness and lowering the threshold for treatments is creating millions of new patients and billions in new profits, in turn threatening to bankrupt national healthcare systems all over the world. This Canadian edition includes an introduction placing the issue in a Canadian context and describing why Canadians should be concerned about the problem.

WHO guideline on country pharmaceutical pricing policies

Author : Anonim
Publisher : World Health Organization
Page : 70 pages
File Size : 41,9 Mb
Release : 2020-09-29
Category : Business & Economics
ISBN : 9789240011878

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WHO guideline on country pharmaceutical pricing policies by Anonim Pdf

In recent years, high prices of pharmaceutical products have posed challenges in high- and low-income countries alike. In many instances, high prices of pharmaceutical products have led to significant financial hardship for individuals and negatively impacted on healthcare systems' ability to provide population-wide access to essential medicines. Pharmaceutical pricing policies need to be carefully planned, carried out, and regularly checked and revised according to changing conditions. Strong, well-thought-out policies can guide well-informed and balanced decisions to achieve affordable access to essential health products. This guideline replaces the 2015 WHO guideline on country pharmaceutical pricing policies, revised to reflect the growing body of literature since the last evidence review in 2010. This update also recognizes country experiences in managing the prices of pharmaceutical products.

Crossing the Global Quality Chasm

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on Global Health,Committee on Improving the Quality of Health Care Globally
Publisher : National Academies Press
Page : 399 pages
File Size : 41,7 Mb
Release : 2019-01-27
Category : Medical
ISBN : 9780309477895

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Crossing the Global Quality Chasm by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Board on Global Health,Committee on Improving the Quality of Health Care Globally Pdf

In 2015, building on the advances of the Millennium Development Goals, the United Nations adopted Sustainable Development Goals that include an explicit commitment to achieve universal health coverage by 2030. However, enormous gaps remain between what is achievable in human health and where global health stands today, and progress has been both incomplete and unevenly distributed. In order to meet this goal, a deliberate and comprehensive effort is needed to improve the quality of health care services globally. Crossing the Global Quality Chasm: Improving Health Care Worldwide focuses on one particular shortfall in health care affecting global populations: defects in the quality of care. This study reviews the available evidence on the quality of care worldwide and makes recommendations to improve health care quality globally while expanding access to preventive and therapeutic services, with a focus in low-resource areas. Crossing the Global Quality Chasm emphasizes the organization and delivery of safe and effective care at the patient/provider interface. This study explores issues of access to services and commodities, effectiveness, safety, efficiency, and equity. Focusing on front line service delivery that can directly impact health outcomes for individuals and populations, this book will be an essential guide for key stakeholders, governments, donors, health systems, and others involved in health care.

Equitable Access to High-Cost Pharmaceuticals

Author : Zaheer-Ud-Din Babar
Publisher : Academic Press
Page : 238 pages
File Size : 50,9 Mb
Release : 2018-02-27
Category : Business & Economics
ISBN : 9780128119624

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Equitable Access to High-Cost Pharmaceuticals by Zaheer-Ud-Din Babar Pdf

Equitable Access to High-Cost Pharmaceuticals seeks to aid the development and implementation of equitable public health policies by pharmaco-economics professionals, health economists, and policymakers. With detailed country-by country analysis of policy and regulation, the Work compares and contrasts national healthcare systems to support researchers and practitioners identify optimal healthcare policy solutions. The Work incorporates chapters on global regulatory changes, health technology assessment guidelines, and competitive effectiveness research recommendations from international bodies such as the OECD or the EU. Novel policies such as horizon scanning, managed-entry agreement and post-launch monitoring are considered in detail. The Work also thoroughly reviews novel pharmaceuticals with particular research interest, including cancer drugs, orphan medicines, Hep C, and personalized medicines. Evaluates impact and efficacy of current access policies and pricing regulation of high-cost drugs Incorporates existing guidelines and recommendations by international organizations Compares and contrasts how different countries fund and police high-cost drug access Explores novel and emergent policies, including managed entry agreement, analysis of real world data and differential pricing Reviews novel pharmaceuticals of current research interest

Bottle of Lies

Author : Katherine Eban
Publisher : HarperCollins
Page : 512 pages
File Size : 48,5 Mb
Release : 2020-06-23
Category : Medical
ISBN : 9780063054103

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Bottle of Lies by Katherine Eban Pdf

A NEW YORK TIMES BESTSELLER New York Times 100 Notable Books of 2019 New York Public Library Best Books of 2019 Kirkus Reviews Best Health and Science Books of 2019 Science Friday Best Books of 2019 New postscript by the author From an award-winning journalist, an explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale—The Jungle for pharmaceuticals Many have hailed the widespread use of generic drugs as one of the most important public-health developments of the twenty-first century. Today, almost 90 percent of our pharmaceutical market is comprised of generics, the majority of which are manufactured overseas. We have been reassured by our doctors, our pharmacists and our regulators that generic drugs are identical to their brand-name counterparts, just less expensive. But is this really true? Katherine Eban’s Bottle of Lies exposes the deceit behind generic-drug manufacturing—and the attendant risks for global health. Drawing on exclusive accounts from whistleblowers and regulators, as well as thousands of pages of confidential FDA documents, Eban reveals an industry where fraud is rampant, companies routinely falsify data, and executives circumvent almost every principle of safe manufacturing to minimize cost and maximize profit, confident in their ability to fool inspectors. Meanwhile, patients unwittingly consume medicine with unpredictable and dangerous effects. The story of generic drugs is truly global. It connects middle America to China, India, sub-Saharan Africa and Brazil, and represents the ultimate litmus test of globalization: what are the risks of moving drug manufacturing offshore, and are they worth the savings? A decade-long investigation with international sweep, high-stakes brinkmanship and big money at its core, Bottle of Lies reveals how the world’s greatest public-health innovation has become one of its most astonishing swindles.

Global Pharmaceutical Policy

Author : Frederick M. Abbott,Maurice Nelson Graham Dukes,Graham Dukes
Publisher : Edward Elgar Publishing
Page : 319 pages
File Size : 48,9 Mb
Release : 2009-01-01
Category : Law
ISBN : 9781849801843

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Global Pharmaceutical Policy by Frederick M. Abbott,Maurice Nelson Graham Dukes,Graham Dukes Pdf

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.

Vaccines, Medicines and COVID-19

Author : Germán Velásquez
Publisher : Springer Nature
Page : 129 pages
File Size : 54,8 Mb
Release : 2022-01-01
Category : Medical
ISBN : 9783030891251

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Vaccines, Medicines and COVID-19 by Germán Velásquez Pdf

This open access book is a collection of research papers on COVID-19 by Germán Velásquez from 2020 and early 2021 that help to answer the question: How can an agency like the World Health Organization (WHO) be given a stronger voice to exercise authority and leadership? The considerable health, economic and social challenges that the world faced at the beginning of 2020 with COVID-19 continued and worsened in many parts of the world in the second-half of 2020 and into 2021. Many of these countries and nations wanted to explore COVID-19 on their own, sometimes without listening to the main international health bodies such as WHO, an agency of the United Nations system with long-standing experience and vast knowledge at the global level and of which all countries in the world are members. In this single volume, the chapters present the progress of thinking and debate — particularly in relation to drugs and vaccines — that would enable a response to the COVID-19 pandemic or to subsequent crises that may arise. Among the topics covered: COVID-19 Vaccines: Between Ethics, Health and Economics Medicines and Intellectual Property: 10 Years of the WHO Global Strategy Re-thinking Global and Local Manufacturing of Medical Products After COVID-19 Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock Intellectual Property and Access to Medicines and Vaccines The World Health Organization Reforms in the Time of COVID-19 Vaccines, Medicines and COVID-19: How Can WHO Be Given a Stronger Voice? is essential reading for negotiators from the 194 member countries of the World Health Organization (WHO); World Trade Organization (WTO) and World Intellectual Property Organization (WIPO) staff participating in these negotiations; academics and students of public health, medicine, health sciences, law, sociology and political science; and intergovernmental organizations and non-governmental organizations that follow the issue of access to treatments and vaccines for COVID-19.

Regulating Medicines in a Globalized World

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines
Publisher : National Academies Press
Page : 169 pages
File Size : 41,5 Mb
Release : 2020-04-25
Category : Medical
ISBN : 9780309498630

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Regulating Medicines in a Globalized World by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines Pdf

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.

A Practical Approach to Pharmaceutical Policy

Author : Andreas Seiter
Publisher : World Bank Publications
Page : 238 pages
File Size : 54,5 Mb
Release : 2010-06-17
Category : Medical
ISBN : 0821383876

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A Practical Approach to Pharmaceutical Policy by Andreas Seiter Pdf

This book offers policy makers a hands-on approach, tested in the World Bank’s field work in many countries, for developing policies that improve access to safe, effective medicines in health systems of low- and middle-income economies.

When People Come First

Author : João Biehl,Adriana Petryna
Publisher : Princeton University Press
Page : 454 pages
File Size : 49,6 Mb
Release : 2013-07-07
Category : Social Science
ISBN : 9780691157399

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When People Come First by João Biehl,Adriana Petryna Pdf

A people-centered approach to global health When People Come First critically assesses the expanding field of global health. It brings together an international and interdisciplinary group of scholars to address the medical, social, political, and economic dimensions of the global health enterprise through vivid case studies and bold conceptual work. The book demonstrates the crucial role of ethnography as an empirical lantern in global health, arguing for a more comprehensive, people-centered approach. Topics include the limits of technological quick fixes in disease control, the moral economy of global health science, the unexpected effects of massive treatment rollouts in resource-poor contexts, and how right-to-health activism coalesces with the increased influence of the pharmaceutical industry on health care. The contributors explore the altered landscapes left behind after programs scale up, break down, or move on. We learn that disease is really never just one thing, technology delivery does not equate with care, and biology and technology interact in ways we cannot always predict. The most effective solutions may well be found in people themselves, who consistently exceed the projections of experts and the medical-scientific, political, and humanitarian frameworks in which they are cast. When People Come First sets a new research agenda in global health and social theory and challenges us to rethink the relationships between care, rights, health, and economic futures.