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

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.

This exciting new book embarks on a comparative analysis of competition law and policy in Japan and the EU. It provides a clear and carefully researched exposition of the differences between the relevant rules, systems and underlying ideas of the two j

Medicine regulation demands the application of sound medical, scientific, and technical knowledge and skills, and operates within a legal framework. Regulatory functions involve interactions with various stakeholders (e.g., manufacturers, traders, consumers, health professionals, researchers, and governments) whose economic, social, and political motives may differ, making implementation of regulation both politically and technically challenging. This book discusses regulatory landscape globally and the current global regulatory scenario of medicinal products and food products comprehensively. Features: Discusses how recent developments of medicinal and food products have opened up innovative solutions for many of the current challenges societies face presently. Explores the manifold variations between the regulatory bodies in different countries that have not previously been collected to this extent. Presents details on the substantial progress in analytical methodologies for labelling applications and the creation of appropriate test criteria for pharmaceuticals and their safety analysis. Reviews how more worldwide collaboration and cooperation in the regulatory area is still required.

Pharmaceuticals is a large, high-growth, globalized, & innovation intensive industry. Pharmaceuticals has long been a stronghold of the European industry, & it still provides by far the largest contribution to the European trade balance in high-technology, R&D intensive sectors. However, it is now a diffused perception that the European pharmaceutical industry is losing ground vis-a-vis the U.S. Against this background, the Report examines the competitive position of the European pharmaceutical companies & industries, & compares them with the pharmaceutical companies & industries in other parts of the world, particularly the U.S. Charts, tables & graphs.

Intellectual property (IP) is a key component of the life sciences, one of the most dynamic and innovative fields of technology today. At the same time, the relationship between IP and the life sciences raises new public policy dilemmas. The Research Handbook on Intellectual Property and the Life Sciences comprises contributions by leading experts from academia and industry to provide in-depth analyses of key topics including pharmaceuticals, diagnostics and genes, plant innovations, stem cells, the role of competition law and access to medicines. The Research Handbook focuses on the relationship between IP and the life sciences in Europe and the United States, complemented by country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective.

This book addresses three important concepts in the economy—competition, innovation, and growth—using various cases and available data in Japan and other countries. First, the authors discuss competition, including global competition, to provide a better understanding of competition policy in Japan. Then, the authors examine the effects of human capital and alliance on innovation while providing new innovation indicators. Moreover, the authors examine growth from the perspective of corporate strategy such as acquisition, including international comparison. The interplay of competition, innovation, and growth has been prevalent in Japan, and it still acts as a catalyst for stimulating the stagnant economy. A better understanding of competition, innovation, and growth provides the tools to reinvigorate the stagnant economy in Japan and to reinforce the economy in other countries where the period of rapid growth has ended.

This long-awaited new book from Cynthia Day Wallace picks up the thread of her best-selling "Legal Control of the Multinational Enterprise: National Regulatory Techniques and the Prospects for International Controls," In the present work she applies herself to legal and pragmatic aspects of control surrounding MNE operations. The primary focus is on legal and administrative techniques and measures practised by host states to control - transparently or less so - foreign MNE activity within their territories, or even extraterritorially when effects are felt within national boundaries. The primary geographic focus is the six most investment-intensive industrialized states (namely, Canada, France, Germany, Japan, the United States and the United Kingdom). At the same time an important message of the present study is precisely the implication for the developing countries as well as for the emerging market economies of central and eastern Europe - and even Asian nations besides Japan, because it is the sharing of this very 'experience of years' that can best serve to facilitate a fuller participation on the part of the up-and-coming economies in the same global market place.