The Nature of Managing Regulations Regarding Regenerative Medicine in Japan

Abstract

Background & Aim As the dramatic advancement of stem cell therapies ensures the value and trust of regenerative medicine in society, this requires increasingly robust ethicolegal considerations on these cell therapies. Like other counties, Japan has significantly addressed these considerations. As a result, Japan has led to establishing specific laws of regenerative medicine, where the Act on the Safety of Regenerative Medicine (ASRM) plays a key role in governing both clinical research and treatment of stem cell therapies. Since the ASRM is currently under revision, various scholars and policy makers are proactively approaching this process. On the other hand, the observation and analysis of the ASRM from a long-range perspective can provide new useful insights for its future nature and direction. Methods, Results & Conclusion From this perspective, in this study, we explore outstanding ethical and legal properties of the current Japanese regulations in question. As an example, our study sheds light on the approach of risk classifications using stem cells in the ASRM. While risk classifications of the ASRM, such as class 1 (high risk), class 2 (middle risk) and class 3 (low risk) emphasize technological aspects regarding stem cells, there is a possibility for this technological approach not necessarily to be effective or efficient in light of their review processes, such as safety assessments and operation processes. In our presentation, we will show more details of risk classifications in the ASRM, and furthermore, our research can be beneficial for the further promotion of stem cell therapies, along with a balance of participant’ rights, research and social value.