Regulation Innovation And Competition In Pharmaceutical Markets

This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition laws, and public health in prescription drugs markets, examining their interconnections and the delicate balance between the various interests and policy goals at stake. Although pharmaceutical markets are heavily regulated and subject to close antitrust scrutiny, there is a constant requirement for existing rules and policies to tackle a number of persistent, complex issues. The variety of anticompetitive practices occurring in this sector, the worrying rise in drug prices, and major, far-reaching concerns over the accessibility of medicines are sources of frequent controversy in academic and policy debate. Understanding the unique features and dynamics of the pharmaceutical industry requires a tailored and multifaceted approach. The study is enhanced by the adoption of a comparative perspective, tracing convergence and divergence between EU and US systems through the analysis of relevant applicable rules, emblematic case studies, and policy choices. Pursuant to this rigorous approach, the book provides an original and thought-provoking critique of the challenges of regulating pharmaceutical markets.

Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

The pharmaceutical industry is one of today’s most dynamic and complex industries, involving commercialization of cutting-edge scientific research, a huge web of stakeholders (from investors to doctors), multi-stage supply chains, fierce competition in the race to market, and a challenging regulatory environment. The stakes are high, with each new product raising the prospect of spectacular success—or failure. Worldwide revenues are approaching $1 trillion; in the U.S. alone, marketing for pharmaceutical products is, itself, a multi-billion dollar industry. In this volume, the editors showcase contributions from experts around the world to capture the state of the art in research, analysis, and practice, and covering the full spectrum of topics relating to innovation and marketing, including R&D, promotion, pricing, branding, competitive strategy, and portfolio management. Chapters include such features as: · An extensive literature review, including coverage of research from fields other than marketing · an overview of how practitioners have addressed the topic · introduction of relevant analytical tools, such as statistics and ethnographic studies · suggestions for further research by scholars and students The result is a comprehensive, state-of-the-art resource that will be of interest to researchers, policymakers, and practitioners, alike.

Examine the global pharmaceutical industry and the effect of national, regulatory, economic, and market environments on the competitiveness of the industry! This unique book is the only empirical study that examines the effects of the national environment on the competitiveness of a country's pharmaceutical industry. This informative book explores such topics as the types of comparative advantages that firms use for developing competitive advantages and what strategic choices firms should make when collaborating with international firms. Public policy implications with respect to the economic environment are also discussed to give you a complete look at the international pharmaceutical industry. Global Competitiveness in the Pharmaceutical Industry recognizes pharmaceutical industries as being of great social and public importance to all countries, since so many life saving drugs have emerged from pharmaceutical laboratories over the past four decades. By helping to combat many fatal diseases and eradicate others, drug producers have helped to positively alter mortality patterns in many parts of the world, thus making companies compete to provide many important medicines. The unique research presented in this book examines the determinants of global competitive advantage in the pharmaceutical industry by answering such questions as: Which factors stimulate or inhibit a nation's pharmaceutical industry to be globally innovative? Which factors stimulate or inhibit diffusion of pharmaceutical innovations (NECs) into its markets? Are there differences between industrialized and developing countries with respect to factors that affect innovation and global competitiveness in the pharmaceutical industry? Global Competitiveness in the Pharmaceutical Industry makes several theoretical, empirical, and methodological contributions which lead to results and generate important managerial and public policy implications. You will find a comprehensive overview of the nature of global competition in the pharmaceutical industry and its evolution in the post World War II period. Global Competitiveness in the Pharmaceutical Industry provides you with an in-depth understanding of the dynamics and importance of the global pharmaceutical market.

This is the first book published that focuses on competition law and policy in the Japanese pharmaceutical sector. It consists of chapters written and edited by academics who research the industry from various perspectives, including economics, competition law, pharmaceutical regulations, and intellectual property law. Competition policies involving pharmaceutical products attract attention from academics and policymakers worldwide. The pharmaceutical industry is regulated by drug laws that vary from country to country and are affected by differing practices and industrial structures. The book begins by examining drug regulations and trade practices in the industry that are peculiar to Japan and its healthcare system. It then presents the Japanese Antimonopoly Act and cases involving it, and discussions of current competition law issues in the Japanese pharmaceutical industry. The book also discusses innovation and intellectual property and economic analyses of pharmaceutical regulations and drug discovery. The chapters include comparative studies on Japanese regulations vs. those in the European Union and the United States. Japan is one of the biggest pharmaceutical markets in the world. With this in mind, the book provides “one-stop shopping” for anyone interested in pharmaceutical regulations in the country. Covering the basics but extending to in-depth explorations of complex problems, this book appeals not only to students and academics, pharmaceutical companies and regulators, but also to those dealing with real-world policy issues that encompass competition policy, intellectual property, and pharmaceutical regulation. Chapter 11 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com

The pharmaceutical industry is one of the most closely regulated sectors of the Western economies. In this study, Hancher provides one of the first comprehensive analyses of the regulatory systems in France and the United Kingdom, with particular focus on safety, control of price, profit, and promotional restrictions. She offers an examination of regulation as a dynamic process, exploring its impact on the operating environment of major research-based firms, and comparing the ways in which different legal cultures may provide different opportunities or impose different forms of constraint on policy makers.

This is the first book to examine how effectively American and supranational EU governments have regulated innovative pharmaceuticals during the last 30 years regarding public health. It explains why pharmaceutical regulation has been misdirected by commercial interests and misconceived ideologies.