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.