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.
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.
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.
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.
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
A drug policy is a crucial ingredient in every country's national health strategy as it provides a strategic framework to identify goals and commitments. This publication discusses the key components of such a policy. Issues covered include: the selection of essential drugs, affordability; finance and supply; regulation and quality assurance; rational use; research; human resources; monitoring and evaluation.
Improving access to safe, effective, and quality medicines and other health technologies is a critical public health priority and a fundamental requisite for universal health. National regulatory systems play a key part in a country's health system by overseeing the safety, quality, and efficacy of all health technologies, including pharmaceuticals, vaccines, blood and blood products, and medical devices, among others. The aim of this document is to better understand the regulatory landscape of the Americas, with an emphasis on Latin American National Regulatory Authorities of Reference. This report presents data and analysis corresponding to essential regulatory functions and systems foundations to understand current practices, identify critical issues, and present a series of recommendations for action. The report also includes an overview of the market outlook and economic integration mechanisms in the Americas and their influence on regulatory policy and pharmaceutical trade. In addition, the report includes a supplement to describe salient regulatory emergency responses to the COVID-19 pandemic in the Americas. Through this report, the Pan American Health Organization aims to increase the understanding of national regulatory remits and capacity in the Americas, raise awareness and appreciation of the regional regulatory progress and challenges, identify the regulatory issues emerging markets will bring, and highlight opportunities for evidence-based regulatory system strengthening.
Social and Administrative Aspects of Pharmacy in Low- and Middle-Income Countries: Present Challenges and Future Solutions examines the particularities of low- and middle-income countries and offers solutions based on their needs, culture and available resources. Drawing from the firsthand experience of researchers and practitioners working in these countries, this book addresses the socio-behavioral aspects of pharmacy and health, pharmacoeconomics, pharmaceutical policy, supply management and marketing, pharmacoepidemiology and public health pharmacy specific to low- and middle-income countries. While some practices may be applied appropriately in disparate places, too often pharmacy practice in low- and middle-income countries is directly copied from successes in developed countries, despite the unique needs and challenges low- and middle-income countries face. - Examines key issues and challenges of pharmacy practice and the pharmaceutical sector specific to low- and middle-income countries - Compares pharmacy practice in developed and developing countries to highlight the unique challenges and opportunities of each - Provides a blueprint for the future of pharmacy in low- and middle-income countries, including patient-centered care, evidence-based care and promoting the role of the pharmacist for primary health care in these settings
This book applies an established analytical framework for health sector reform (Getting Health Reform Right, Oxford, 2004) to the performance problems of the pharmaceutical sector. The book is divided into three sections. The first section presents the basic ideas for analysis. It begins by insisting that reform start with a clear understanding of the performance deficiencies of the current system. Like all priority setting in the public sector, this 'definition of the problem' involves both ethical choices and political processes. Early chapters explain the foundations of these ideas and apply them to the pharmaceutical sector. The relationship of ultimate outcomes (like health status or risk protection) to classic health systems concepts like efficiency, access and quality is also explored. The last chapter in the first part is devoted to 'diagnosis'—explaining how to move from the definition of a problem to an understanding of how the functioning of the system produces the undesirable outcomes in question. The second part of the book devotes one chapter to each of five 'control knobs': finance, payment, organization, regulation and persuasion. These are sets of potential interventions that governments can use to improve pharmaceutical sector performance. Each chapter presents basic concepts and discusses examples of reform options. Throughout we provide 'conditional guidance'—avoiding the approach of a 'one size fits all' model of 'best practices' in these five arenas for reform. Instead we stress the need for local knowledge of political systems, administrative capacities, community values and market conditions in order to design pharmaceutical sector policies appropriate to a country’s particular circumstances. The last part of the book is a set of teaching cases. Each is preceded by questions and is followed by a brief note on the lessons to be learned. The goal is to help readers develop the skills they need to deal effectively with pharmaceutical sector reform problems in their own countries.
Pharmacy Practice in Developing Countries: Achievements and Challenges offers a detailed review of the history and development of pharmacy practice in developing countries across Africa, Asia, and South America. Pharmacy practice varies substantially from country to country due to variations in needs and expectations, culture, challenges, policy, regulations, available resources, and other factors. This book focuses on each country's strengths and achievements, as well as areas of weakness, barriers to improvement and challenges. It sets out to establish a baseline for best practices, taking all of these factors into account and offering solutions and opportunities for the future. This book is a valuable resource for academics, researchers, practicing pharmacists, policy makers, and students involved in pharmacy practice worldwide as it provides lessons learned on a global scale and seeks to advance the pharmacy profession. - Uses the latest research and statistics to document the history and development of pharmacy practice in developing countries - Describes current practice across various pharmacy sectors to supply a valuable comparative analysis across countries in Africa, Asia, Europe, and South America - Highlights areas of achievement, strengths, uniqueness, and future opportunities to provide a basis for learning and improvement - Establishes a baseline for best practices and solutions
