A Real Plan for Making Drugs Affordable–and Promoting Innovation, Too “This book is a necessity for understanding the pharmaceutical industry. Both the pluses and minuses of the present system are set forth with a judicious combination of historical narrative, economic analysis, and statistical data. The highly original proposals for reform will be a major stimulant to analysis and policy-making.” –Kenneth Arrow, Nobel Laureate in Economics, Professor Emeritus, Stanford University “This is a timely book by authors who know what they are talking about. They tackle a big problem: rising drug prices that are threatening to overwhelm us all–and especially those with limited or absent health care insurance. Will we drive people overseas for healthcare? Will there be social unrest? This book describes the problem and then offers a solution. Worth a careful read by everyone, pharmaceutical manufacturers and government policymakers especially.” –Roger Williams, M.D., Chief Executive Officer of the United States Pharmacopeia and a former senior official of the Food and Drug Administration “This book confounds two sets of skeptics: Those who say there’s no way to resolve the conflict between the need to fund pharmaceutical research and our desire to keep medicine affordable; and those who think that economics never has anything good to say.” –Honorable Barney Frank, Congressman from Massachusetts “This book comes at the right time and could become the starting point of discussions, which will eventually lead us into new era in the healthcare care industry. It will without a doubt become a must for insiders of the pharma- and biotech industries.” –Dr. Jürgen Drews, retired President of Roche Pharmaceutical Group Global Research Acknowledgments viii About the Authors ix Introduction xi Chapter 1: Drugs and Drug Prices 1 Chapter 2: The American Way to Discover Drugs 21 Chapter 3: The Drug Industry Today 39 Chapter 4: Are Drug Companies Risky? 59 Chapter 5: How Not to Lower Drug Prices 77 Chapter 6: Squandering R & D Resources 103 Chapter 7: How to Lower Drug Prices 129 Appendix: Our Solution in Detail 155 Index 177

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.

In this book, Marc Rodwin examines the development of conflicts of interest in the health care systems of the US, France, and Japan. He shows that national differences in the organization of medical practice and the interplay of organized medicine, the market, and the state give rise to variations in the type and prevalence of such conflicts, and then analyzes the strategies that each nation employs to cope with them. Drawing on the experiences of these three nations, Conflicts of Interest and the Future of Medicine demonstrates that we can mitigate these problems with carefully planned reform and regulation.

Hein and Moon take up a serious problem of contemporary global governance: what can be done when international trade rules prevent the realization of basic human rights? Starting in the 1990s, intellectual property obligations in trade agreements required many developing countries to begin granting medicines patents, which often rendered lifesaving drugs unaffordable. At stake was the question of what priority would be given to health-particularly of some of the world’s poorest people-and what priority to economic interests, particularly those of the most powerful states and firms. This book recounts the remarkable story of the access to medicines movement. The authors offer an explanation for how the informal, but powerful norm that every person should have access to essential medicines emerged after a decade of heated political contestation and against long odds. They also explore the stability and scope of the norm. Finally, the book examines the limitations of informal norms for protecting human rights, and when renewed focus on changing formal norms is warranted.

Examining the boundaries between recreational and medicinal drugs in the eyes of the public and the law.

This book challenges the static, ahistorical models on which Economics continues to rely. These models presume that markets operate on a "frictionless" plane where abstract forces play out independent of their institutional and spatial contexts, and of the influences of the past. In reality, at any point in time exogenous factors are themselves outcomes of complex historical processes. They are shaped by institutional and spatial contexts, which are "carriers of history," including past economic dynamics and market outcomes. To examine the connections between gradual, evolutionary change and more dramatic, revolutionary shifts the text takes on a wide array of historically salient economic questions—ranging from how formative, European encounters reconfigured the political economies of indigenous populations in Africa, the Americas, and Australia to how the rise and fall of the New Deal order reconfigured labor market institutions and outcomes in the twentieth century United States. These explorations are joined by a common focus on formative institutions, spatial structures, and market processes. Through historically informed economic analyses, contributors recognize the myriad interdependencies among these three frames, as well as their distinct logics and temporal rhythms.

When the European Court of Justice and the Court of First Instance drafts its own procedural rules, and when it makes decisions on procedural matters, it turns to the highly regarded Lasok's European Court Practice and Procedure for confirmation and guidance. Fully revised and updated the fourth edition: 1. Explains the implications of Brexit and the residual jurisdiction of the ECJ in relation to the UK under the Withdrawal Agreement. 2. Takes account of and provide in-depth analysis of all case law since the previous edition. 3. Provides guidance on the new General Court Rules of Procedure. 4. Provides new commentary on the Judges and Advocates General caused by Brexit and the current ongoing litigation concerning Advocate General Sharpston. 5. Includes additional commentary on the confidentiality regime for cases raising security concerns. Written by the internationally acknowledged expert in this area of law Lasok's European Court Practice and Procedure is the leading and must have work for anyone preparing a case to be heard before the European Court of Justice. This title is included in Bloomsbury Professional's Practice and Procedure online service.