Abstract

How to Regulate Unproven Cellular Therapies, Beyond “Right to Try”

Kunihiko Suzuki, Vice Chairman & Member of the Board, Medinet Co. Ltd., Vice Chair, Forum for Innovative Regenerative Medicine (FIRM)

There are some movement recently in regulation for so-called “unproven cellular therapies” (UCT)/“unregulated market product”, which private hospitals/clinics may provide medical care/medical treatment to patients. According to the report (Cell Stem Cell 19, August 4, 2016 Elvsevier Inc.), there are 570 clinics which offer stem cell interventions to the public without any market authorization as a product from FDA.  In addition, in November last year, FDA published 4 Guidances for HCTPs, which seem to put on target towards UCTs and gave warning letters to the clinics in California and also Miami, FL.  However, at the same time, “Right to try” bills are under lots of discussions among the various parties. In general, there has been no specific regulation to control the activities of medical care/medical treatment by medical doctors/dental doctors before Japan introduced “The Act on the Safety of Regenerative Medicine” (ASRM).  With the new regulation in Japan, we can reach to the statistics of clinics/hospitals which involve care/treatment with non market-authorized products by MHLW/PMDA and/or the details of such medical care/medical treatment. It is worthwhile for everyone in this space to learn benefit/outcome/limitation on ASRM to bring cutting-edge medical technologies with safe and efficacious manner to the patients. Hope Japanese regulatory framework will be the pilot model for the regulations of other countries in future.