With a series of recent advancements in pharmaceutical market access, Japan is transforming into a market where companies with innovative products can benefit from more opportunities. In addition, a new legal framework was established in November 2014 to accelerate R&D and commercialization of regenerative medicine products in Japan. Two regenerative medicine products have been approved under this new framework, capitalizing on a much faster commercialization path. The Japanese government has identified the life sciences industry as one of the key strategic industries that can contribute to mid- to long-term national economic growth. To support this growth, the MHLW is committed to further improve market access in the pharmaceutical and regenerative medicine markets with the aim of attracting more interest from a range of domestic and overseas players. Meanwhile, the government is also expected to develop cost-containment measures that mostly target less innovative drugs and oversold products, with the intention of curbing the growth of national healthcare costs.

Questions Answered in This Report:

  • What do you view as the most effective improvement/policy change in pharmaceutical market access in Japan in recent years?

  • How do you think HTA can be integrated into the Japanese healthcare system?

  • How will the passage of the two acts on regenerative medicine in November 2014 affect industrialization of regenerative medicine in Japan?

  • How long do you think it will take to turn regenerative medicine into a successful business?

  • What additional policies/steps do you think would be essential for advancing industrialization of regenerative medicine in the future?
Author(s): Hiroshi Tashiro, M.Sc.