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 pharmaceuticalregulations 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

Autorentext

Akira Negishi is a Professor Emeritus of Kobe University, where he was the dean of the faculty of law, and Konan University where he was a vice president. At these institutions he taught competition, consumer and other economic laws. He has published numerous scholarly books, articles and commentaries and led a number of research projects and academic groups in these fields. Professor Negishi was also the president of the Japan Association of Economic Law and the Japan Association of International Economic Law, the chair of the Telecommunication Business Subcommittee, the Information Communication Council, the Ministry of Internal Affairs and Communications (MIC) and the Antimonopoly Forum. He served as a counsellor for the Japan Fair Trade Commission (JFTC), a member of the Advisory Panel on Basic Issues Regarding the Antimonopoly Act, and as the bar examiner for the Ministry of Justice. He has chaired countless expert and advisory groups at the JFTC, MIC and the Ministry of Economy, Trade and Industry. He became a member of the Japan Academy, an honorary organisation that accords special recognition to researchers with eminent academic and scientific achievements in 2018.

Masako Wakui is a professor at the Graduate School of Law, Kyoto University and a visiting scholar at Newcastle University, UK. She has previously taught at Osaka City University and Rikkyo University. Her fields are competition law and policy. She has published books and articles on these subjects. She has served as a chief researcher for the Japan Fair Trade Commission (JFTC) Competition Policy Research Centre, as a commissioner at the Osaka Prefecture Labour Relations Commission and as a member of the Interconnection Policy Committee, the Information and Communications Council, the Ministry of Internal Affairs and Communication and various other advisory and study groups at the JFTC and other administrative bodies. Currently, Dr Wakui is a board member of the Japan Association of Economic Law and the co-head of the Asian Chapter of the Academic Society for Competition Law.

Naoko Mariyama has taught at Tokai University since 2014 and has served as an associate professor at its Undergraduate School of Law since 2017, where she teaches the Japan Antimonopoly Act. She received her master's from Doshisha University, where she majored in competition law. She was a visiting scholar at King's College London in 2019-2020. She lectured at group training courses held by Japan Fair Trade Committee and Japan International Cooperation Agency on the Antimonopoly Act and on competition policy for developing countries during 2011-2016. Her main research interest is competition law and policy in pharmaceutical industry and she has published articles on this theme both in English and Japanese. Professor Mariyama has been a member of bid audit committees in two Japanese cities. She is also a regular speaker at the Antimonopoly Study Group and leads the pharmaceutical study group for the Kobe University Innovation and Platform research project.

Inhalt

I. Healthcare and pharmaceuticals: Innovation and regulation in Japan

Building a Sustainable Medical Care Delivery System and Competition Policy Goro Sato

Drug Regulation in Japan

Yutaka Tejima

Collaboration between the Patent System and Pharmaceutical Regulations for Drug-Discovery Innovation in Japan Takeshi Maeda

Corruption and Conflict of Interest in the Pharmaceutical Market in Japan

Masako Wakui

II. The Japanese Antimonopoly Act and its relation to the pharmaceutical industry

Antimonopoly Act and Its Application to the Pharmaceutical Industry in Japan

Akira Negishi

Horizontal Cooperation and Alliances among Pharmaceutical Companies in the Japanese Antimonopoly Act

Shingo Seryo

Merger Regulations in the Pharmaceutical Industry in Japan

Kuninobu Takeda

Pay-For-Delay Agreements in Japan

Naoko Mariyama

Non-Challenge Clause in the Pharmaceutical Sector and the AMA

Thomas K. Cheng

Will Authorised Biologics Deter Biosimilars?: Utilising JFTC's Expertise in Drug Pricing

Takanori Abe

III. An economic Analysis of the pharmaceutical industry and trade practices in Japan

The Pharmaceutical Industry in Japan: A History of Its Development Kenta Nakamura

Trade Practices in the Japanese Pharmaceutical Market: Modelling and Simulation of Improvement Policies Konosuke Noto