Bioethik und Recht in Japan. Die demokratische Legitimität der Rechtsetzung im Bereich der Biomedizin


  • Cornelia Hagedorn


The paper deals with the legal situation in Japan in the field of biomedicine and considers the democratic legitimacy of the legislative procedures in this area. After giving an overview of the existing laws and regulations and a short introduction to the notion of democratic legitimacy the main actors of Japanese legislation in biomedical issues are described.

Apart from two acts, the Law on Organ Transplantation (1997) and the Law Concerning Regulation Relating to Human Cloning Techniques and Other Similar Techniques (2001) and one legally binding guideline based on the Cloning Law, the legal situation is mainly characterized by legally non-binding ministerial guidelines. Examples are the Guidelines for Derivation and Utilization of Human Embryonic Stem Cells of the MEXT and the Ethical Guideline for Human Genome and Gene Analysis Research of the departments MEXT, MHLW and MITI. In addition, professional societies play an important role in setting standards for treatment in ethically problematic areas such as artificial fertilisation.

The Japanese Parliament on the other hand refrains widely from regulating biomedical issues and leaves the field to the expert committees (shingi-kai) of the ministerial departments. They are the main actors in the law-making process in this field by drafting, reforming and reporting on guidelines. In the drafting process, Japanese citizens can participate in a consultation procedure by commenting on the drafts via the internet (public comments procedure).

In addition, the Expert Panel on Bioethics of the Council for Science and Technology Policy (CSTP) is designed to discuss broad ethical topics such as the status of the human embryo and to advise the expert committees in the drafting of guidelines. Its role as a national ethics commission is, however, threatened by its dependence on and weak position in the CSTP which is by purpose research-friendly. On the other hand, expert or ethics committees in Japan are widely regarded not as fora for ethical debate but rather as sources of expert-knowledge and a means for the efficient and proper development of legal instruments.

This observation relates with the rare use of ethical or religious arguments in the Japanese bioethics debate which tends to be utilitarian, pragmatic and result-oriented. Other features of the Japanese society that influence the decision-making in biomedical issues are its consensus-driven discussion culture, its hierarchical structure and the eminent power of bureaucrats in the political process.

On the whole, the democratic legitimacy of Japanese legislation in the field of biomedicine is more output- than input-oriented in that it does not qualify as action o f the people but rather as action f o r the people. The only factor of input-legitimacy in the drafting process of guidelines is the right of citizens to comment on the draft and thus a slim chance of influencing its contents. In order to improve the input-legitimacy it would be advisable to strengthen publicity of biomedical issues as well as the role of Parliament in this field.

Output-legitimacy in the Japanese legal situation in the field of biomedicine can be derived from the presumed quality of the guidelines as they are designed by “experts”. However, the criteria for and the process of eligibility to these committees lack transparency and therefore reduce the legitimacy of the committees.





C. Hagedorn, Bioethik und Recht in Japan. Die demokratische Legitimität der Rechtsetzung im Bereich der Biomedizin, ZJapanR / J.Japan.L. 25 (2008), 27–61.