title: The Social Framework Surrounding the Development of Regenerative Medicine in Japan.
abstract: In 2014, the Japanese government amended the laws concerning regenerative medicine. This reform aimed to contribute to the appropriate promotion of regenerative medicine and new drug discovery for intractable diseases using stem cells. It also helped restrict stem cell tourism, that is, provision of stem cell therapy of unclear efficacy and safety to tourists from abroad, and its relaxed regulations may even lead to the resolution of the drug lag problem. Stem cell medicine is positioned as a part of a national growth strategy that requires cooperation among the industry, government, healthcare field, and academia. It can be characterized as a "mesoscopic strategy," in that it aims to achieve high-level technological developments that would allow results from human-induced pluripotent stem cell and traditional stem cell research to contribute to regenerative medicine and drug development for intractable diseases, while attempting to strike a balance with commercialization and improved access of citizens to cutting-edge medical care.
authors.forename: Eisuke
authors.initials: E
authors.lastname: Nakazawa
authors.forename: Yoshiyuki
authors.initials: Y
authors.lastname: Takimoto
authors.forename: Akira
authors.initials: A
authors.lastname: Akabayashi
mesh_terms: D003299:Cooperative Behavior; D055808:Drug Discovery / Q000331:legislation & jurisprudence*; D006801:Humans; D057026:Induced Pluripotent Stem Cells; D007564:Japan; D044968:Regenerative Medicine / Q000331:legislation & jurisprudence*; D057905:Stem Cell Research / Q000331:legislation & jurisprudence*
keywords: commercialization; iPS cell; medical tourism; regenerative medicine; social framework; stem cell medicine