Pharmaceutical Marketing and Transparency in Japan

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Pharmaceutical Marketing and Transparency in Japan

Marianne Slivkova, Senior Corporate Counsel, Bristol-Myers Squibb Company, USA

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.

Marianne Slivkova is currently Senior Corporate Counsel for Bristol-Myers Squibb. She is primarily responsible for providing legal advice on legal risk, interpretation of FDA advertising regulations, PDMA, healthcare fraud and abuse, product liability, privacy, and antitrust statutes and regulations, other federal and state laws, and company policies and procedures to U.S. marketing, sales and medical management. During 2012, she served as the interim head of BMS’s Japanese legal department, and continues to provide support to BMS’s attorneys based in Japan and Korea. Prior to joining Bristol-Myers Squibb, Ms. Slivkova was a Senior Litigation Associate at Moses & Singer in New York City, and at Dewey Ballantine LLP. Ms. Slivkova is a graduate of the Harvard School of Public Health, New York University School of Law, and Columbia College, Columbia University. She has served as a presenter on Japan at Seton Hall’s Pharmaceutical Compliance Congress in Singapore in 2013. The opinions expressed in this article are solely her own…

Bristol-Myers Squibb is a multi-national biopharmaceutical company, whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

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