Competition Law and Policy in the Japanese Pharmaceutical Sector
Competition Law and Policy in the Japanese Pharmaceutical Sector

Author: Akira Negishi

Publisher: Springer Nature

Published: 2022-02-08

Total Pages: 252

ISBN-13: 9811678146

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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

Pharmaceutical Innovation, Competition and Patent Law
Pharmaceutical Innovation, Competition and Patent Law

Author: Josef Drexl

Publisher: Edward Elgar Publishing

Published: 2013-01-01

Total Pages: 347

ISBN-13: 0857932462

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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.

Antitrust in Pharmaceutical Markets & Geographical Rules of Origin
Antitrust in Pharmaceutical Markets & Geographical Rules of Origin

Author: Pierre Kobel

Publisher: Springer

Published: 2017-09-20

Total Pages: 499

ISBN-13: 3319558137

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This book gathers international and national reports from across the globe on key questions in the field of antitrust and intellectual property. The first part discusses the application of competition law in the pharmaceutical sector, which continues to be a focus for anti-trust authorities around the world. A detailed international report explores the extent to which the application of the competition rules in the pharmaceutical sector should be affected by the specific characteristics of those products and markets (including consumer protection rules, the need to promote innovation, the need to protect public budgets, and other public interest considerations). It provides an excellent comparative study of this complex subject, which lies at the interface between competition law and intellectual property law. The second part of the book gathers contributions from various jurisdictions on the topic of “What rules should govern claims by suppliers about the national or geographic origin of their goods or services?” This section presents an international report, which offers an unparalleled comparative analysis of this topic, bringing together common themes and contrasting the various national provisions dealing with indications of origin, amongst other things. The book also includes the resolutions passed by the General Assembly of the International League of Competition Law (LIDC) following a debate on each of these topics, which include proposed solutions and recommendations. The LIDC is a long-standing international association that focuses on the interface between competition law and intellectual property law, including unfair competition issues.

EU Law of Competition and Trade in the Pharmaceutical Sector
EU Law of Competition and Trade in the Pharmaceutical Sector

Author: Pablo Figueroa

Publisher: Edward Elgar Publishing

Published: 2019

Total Pages: 758

ISBN-13: 1785362615

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This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.

Regulating for Competition
Regulating for Competition

Author: Leigh Hancher

Publisher: Oxford University Press, USA

Published: 1990

Total Pages: 456

ISBN-13:

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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.

Competition Law and IP Rights in Pharmaceuticals and Biotechnology
Competition Law and IP Rights in Pharmaceuticals and Biotechnology

Author: Björn Lundqvist

Publisher: Oxford University Press, USA

Published: 2031-05-30

Total Pages: 576

ISBN-13: 9780198724827

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A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.

Studies on Competition and Antitrust Issues in the Pharmaceutical Industry
Studies on Competition and Antitrust Issues in the Pharmaceutical Industry

Author: Ann-Kathrin Lehnhausen

Publisher: Springer

Published: 2016-11-14

Total Pages: 95

ISBN-13: 3658165510

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This publication examines how drug originator manufacturers manage to shield their products from competition. It characterizes the pharmaceutical industry in detail and analyzes actions that violate antitrust laws in the USA and/or the European Union. The publication examines, for example, pay-for-delay strategies, market foreclosure, resale price maintenance, but also mergers and acquisitions, while taking into account market specificities such as the unique research and development process. The study explains why drug prices sometimes remain at elevated levels even after the drug’s patent protection has expired. Knowing the characteristics of such anticompetitive strategies helps customers such as health insurance companies to develop effective counter-strategies.

Digitalization and Competition Policy in Japan
Digitalization and Competition Policy in Japan

Author: Shuya Hayashi

Publisher: Springer Nature

Published: 2024-01-03

Total Pages: 173

ISBN-13: 9819953103

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This book organizes the intent and purpose of the Japanese competition law (Antimonopoly Act) to address the digitalized socio-economy and provides a detailed explanation of its basic content as well as advanced issues. It includes an overview of Japanese law and its international position, a basic understanding of the big data and AI issues in today's competition law, and perspectives on high-tech regulation. In addition, it includes a variety of important topics, ranging from exploring principles to tackle digital regulatory realities, to understanding and analyzing the competitive realities of multisided markets. It also examines the relationship between information and competition law and that between consumer and competition law. Digitalization is a key concept in our economy and society today. Carbon neutrality initiatives, the need to improve productivity, globalization, and new ways of working are all seeking breakthroughs by way of digitalization. What’s more, digitalization requires free and fair competition in order to encourage technological innovation. The search for transparent and clear competition laws is essential to promote efficient and effective research and development and to promote public awareness through competition.

The Japanese Pharmaceutical Industry
The Japanese Pharmaceutical Industry

Author: Lacy Glenn Thomas

Publisher: Edward Elgar Publishing

Published: 2001

Total Pages: 240

ISBN-13:

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Almost 90 per cent of new drugs are unavailable in Japan. This book presents an analysis of the nature, causes and consequences of this problem, contrasting the Japanese situation with the drug lag experienced in the US. The last chapters look at the various remedies available.