Download or read book Poor Quality Pharmaceuticals in Global Public Health written by Satoru Kimura and published by Springer Nature. This book was released on 2020-01-16 with total page 233 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Countering the Problem of Falsified and Substandard Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-20 with total page 377 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Download or read book Saving Lives Buying Time written by Institute of Medicine and published by National Academies Press. This book was released on 2004-09-09 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Bottle of Lies written by Katherine Eban and published by HarperCollins. This book was released on 2020-06-23 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-03 with total page 366 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book WHO guideline on country pharmaceutical pricing policies written by and published by World Health Organization. This book was released on 2020-09-29 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Bitter Pills written by Muhammad H. Zaman and published by Oxford University Press. This book was released on 2018-03-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Long the scourge of developing countries, fake pills are now increasingly common in the United States. The explosion of Internet commerce, coupled with globalization and increased pharmaceutical use has led to an unprecedented vulnerability in the U.S. drug supply. Today, an estimated 80% of our drugs are manufactured overseas, mostly in India and China. Every link along this supply chain offers an opportunity for counterfeiters, and increasingly, they are breaking in. In 2008, fake doses of the blood thinner Heparin killed 81 people worldwide and resulted in hundreds of severe allergic reactions in the United States. In 2012, a counterfeit version of the cancer drug Avastin, containing no active chemotherapy ingredient, was widely distributed in the United States. In early 2013, a drug trafficker named Francis Ortiz Gonzalez was sentenced to prison for distributing an assortment of counterfeit, Chinese-made pharmaceuticals across America. By the time he was arrested, he had already sold over 140,000 fake pills to customers. Even when the U.S. system works, as it mostly does, consumers are increasingly circumventing the safeguards. Skyrocketing health care costs in the U.S. have forced more Americans to become "medical tourists" seeking drugs, life-saving treatments and transplants abroad, sometimes in countries with rampant counterfeit drug problems and no FDA. Bitter Pills will heighten the public's awareness about counterfeit drugs, critically examine possible solutions, and help people protect themselves. Author Muhammad H. Zaman pays special attention to the science and engineering behind both counterfeit and legitimate drugs, and the role of a "technological fix" for the fake drug problem. Increasingly, fake drugs affect us all.
Download or read book Crossing the Global Quality Chasm written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-01-27 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Vaccines Medicines and COVID 19 written by Germán Velásquez and published by Springer Nature. This book was released on 2022-01-01 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Equitable Access to High Cost Pharmaceuticals written by Zaheer-Ud-Din Babar and published by Academic Press. This book was released on 2018-02-27 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Bad Pharma written by Ben Goldacre and published by Farrar, Straus and Giroux. This book was released on 2013-02-05 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: We like to imagine that medicine is based on evidence and the results of fair testing and clinical trials. In reality, those tests and trials are often profoundly flawed. We like to imagine that doctors who write prescriptions for everything from antidepressants to cancer drugs to heart medication are familiar with the research literature about a drug, when in reality much of the research is hidden from them by drug companies. We like to imagine that doctors are impartially educated, when in reality much of their education is funded by the pharmaceutical industry. We like to imagine that regulators have some code of ethics and let only effective drugs onto the market, when in reality they approve useless drugs, with data on side effects casually withheld from doctors and patients. All these problems have been shielded from public scrutiny because they're too complex to capture in a sound bite. But Ben Goldacre shows that the true scale of this murderous disaster fully reveals itself only when the details are untangled. He believes we should all be able to understand precisely how data manipulation works and how research misconduct in the medical industry affects us on a global scale. With Goldacre's characteristic flair and a forensic attention to detail, Bad Pharma reveals a shockingly broken system and calls for regulation. This is the pharmaceutical industry as it has never been seen before.
Download or read book Disease Control Priorities in Developing Countries written by Dean T. Jamison and published by World Bank Publications. This book was released on 2006-04-02 with total page 1449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on careful analysis of burden of disease and the costs ofinterventions, this second edition of 'Disease Control Priorities in Developing Countries, 2nd edition' highlights achievable priorities; measures progresstoward providing efficient, equitable care; promotes cost-effectiveinterventions to targeted populations; and encourages integrated effortsto optimize health. Nearly 500 experts - scientists, epidemiologists, health economists,academicians, and public health practitioners - from around the worldcontributed to the data sources and methodologies, and identifiedchallenges and priorities, resulting in this integrated, comprehensivereference volume on the state of health in developing countries.
Download or read book Assuring the Quality of Health Care in the European Union written by Helena Legido-Quigley and published by World Health Organization. This book was released on 2008 with total page 242 pages. Available in PDF, EPUB and Kindle. Book excerpt: People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Download or read book Private Patents and Public Health written by Ellen F. M. 't Hoen and published by . This book was released on 2016 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many. 0The AIDS crisis in the late nineties brought access to medicines challenges to the public?s attention, when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis ? 8,000 people dying daily ? the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of low-priced generic HIV medicines. 0But now, high prices of new medicines - for example, for cancer, tuberculosis and hepatitis C - are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises. 0This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.
Download or read book Global Pharmaceutical Policy written by Frederick M. Abbott and published by Edward Elgar Publishing. This book was released on 2009-01-01 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
