Patent rights on pharmaceutical products are one of the factors responsible for the lack of access to affordable medicines in developing countries. In this work, Emmanuel Kolawole Oke provides a systematic analysis of the tension between patent rights and human rights law, contending that, in order to preserve their patent policy space and secure access to affordable medicines for their citizens, developing countries should incorporate a model of human rights into the design, implementation, interpretation, and enforcement of their national patent laws. Through a comprehensive analysis of court decisions from three key developing countries (India, Kenya, and South Africa), Oke assesses the effectiveness of national courts in resolving conflicts between patent rights and the right to health, and demonstrates how a model of human rights can be incorporated into the adjudication of patent rights.

This timely monograph focuses on India and Brazil’s use of compulsory licensing, one of the most significant and controversial TRIPS flexibilities. This is a topical work at this critical time when the COVID-19 has stirred up the debate about compulsory licensing and access to medicines. A closer look into the historical use of compulsory licences in certain countries can offer some takeaways for the current situation. The author studies historical developments and political conditions of the patent system and compulsory licensing from the earliest stage to the modern arena, with a great emphasis on TRIPS. After conducting a cross-national study of India and Brazil, the book moves on to evaluate the different philosophies on compulsory licensing of multilateral organizations such as the EU, the WIPO, the WTO, and NGOs. This important book will strongly appeal to intellectual property students, academics, policymakers, and lawyers practicing in the area. It will also be of interest to academics working in the areas of international law, development, and public health as well as state actors and others with relevant concerns working in multilateral organizations.

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.

COVID-19 is a severe and complex epidemic ravaging many countries. Traditional Chinese medicine (TCM) has accumulated rich experience and achieved outstanding effects in its struggle against epidemics for thousands of years. As an essential intervention means for prevention and control of COVID-19, TCM boasts significant effects in relieving fever symptoms, slowing down disease progression, preventing disease transformation, reducing hormone dosage, and alleviating complications. Establishing and improving the emergency supply service mode of Chinese medicine in response to public health emergencies, and scientifically managing and allocating Chinese medicine medical resources are conducive to establishing a green channel for the emergency supply of Chinese medicine in response to major public health emergencies.This book focuses on the four oral Chinese patent medicines used in the clinical treatment period based on the Guidelines for the Diagnosis and Treatment of COVID-19 by the National Health Commission and National Administration of Traditional Chinese Medicine of China.This work is not only an important part of the theoretical system of TCM treatment based on syndrome differentiation but also an effective way to promote an even deeper integration of clinical pharmaceutical service and clinical medical practice.

During most of the nineteenth century, physicians and pharmacists alike considered medical patenting and the use of trademarks by drug manufacturers unethical forms of monopoly; physicians who prescribed patented drugs could be, and were, ostracized from the medical community. In the decades following the Civil War, however, complex changes in patent and trademark law intersected with the changing sensibilities of both physicians and pharmacists to make intellectual property rights in drug manufacturing scientifically and ethically legitimate. By World War I, patented and trademarked drugs had become essential to the practice of good medicine, aiding in the rise of the American pharmaceutical industry and forever altering the course of medicine. Drawing on a wealth of previously unused archival material, Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.