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International In-house Counsel Journal logoInternational In-house Counsel Journal logo

Pharmaceutical Marketing and Transparency in Japan

Abstract

Japan is a promising market for companies, in-spite of the pressures posed by drug prices, competition and patents. The reason may be the large growth of pharmaceuticals, an aging population, and a pricing scheme which rewards innovative products. As a result, many multinational companies are looking to Japan to provide much needed sources of revenue. However, in many cases the home offices of the multi-nationals have limited familiarity with Japanese law and regulatory schemes, which can present challenges for both legal and compliance professionals. This Article seeks to summarize, at a fairly high level, some of the differences and similarities between select Japanese pharmaceutical promotional regulations and U.S. regulations. It is not an exhaustive overview of all Japanese laws, regulations or Codes that may bear on the marketing of pharmaceutical products in Japan. Rather it is intended as a general overview, which may help non Japanese in-house counsel spot certain issues, and Japanese counsel understand how different U.S. laws and regulations approach some of these same issues. As such, it is hoped that this article will be useful to both in-house counsel operating in Japan to the extent that U.S. approaches are discussed, but also to non-Japanese in house counsel, who may have some dealings with, or oversight responsibility for, Japan.

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Author

Portrait image of Marianne Slivkova
Marianne Slivkova
Senior Corporate Counsel, Acorda Therapeutics, USA

Marianne Slivkova is Director, Legal, Commercial at Acorda Therapeutics. She is primarily responsible for providing legal advice on legal risk, interpretation of FDA advertising regulations, PDMA, healthcare fraud and abuse, product liability, privacy, antitrust statutes and regulations, as well as other federal and state laws, and company policies and procedures to U.S. marketing, sales and medical management, as well as advising on ex-US issues. Prior to joining Acorda, Ms. Slivkova was Senior Corporate Counsel at BMS, and during 2012, she served as the interim head of BMS’s Japanese legal department in Tokyo. Before becoming an in-house attorney, Ms. Slivkova was a Senior Litigation Associate at Moses & Singer in New York City, and at Dewey Ballantine LLP. Ms. Slivkova holds a Master’s of Public Health from the Harvard School of Public Health, a Juris Doctor degree from New York University School of Law, and a Bachelor’s Degree from Columbia College, Columbia University.

Company

Acorda Therapeutics logo

Acorda Therapeutics

Acorda’s mission is to develop therapies that restore function and improve the lives of people with neurological disorders.

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