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IMSUT ORE
Department of Public Policy

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Public policy and medicine—genetic testing, organ transplantation and surrogacy

One of the main research initiatives are genetic testing. As one of the countries that have invested greatly in the field of bioscience, Japan is facing difficulties introducing human genetic research to the market. A key issue is how to regulate the quality of genetic testing. Since genetic testing is a part of clinical laboratory tests, the regulatory framework for these tests should cover the regulation of genetic testing. Nevertheless, the quality of clinical laboratory tests has been regulated largely by the authority of medical professionals. The fact that genetic testing can be provided without supervision of medical professionals reveals the necessity for the regulation of quality of genetic testing. While medical geneticists have publicly criticized direct-to-consumer (DTC) genetic testing, a group of industries related to DTC genetic testing have established self-regulatory guidelines on the quality control of genetic analysis, based on the OECD guidelines. We described the regulatory framework for clinical laboratory tests including genetic tests, and the gaps in regulation, which are particularly highlighted by the appearance of DTC genetic testing. (Watanabe et al 2009)
    Regarding recent revision on organ transplantation act in Japan and its implications, the donor-recipient relationship is primarily contained within families, not only in living organ transplantations, but also in cadaveric transplantation. Surviving family members perform multiple roles, sometimes action against the wishes of the deceased. Nevertheless, both the definition of a family and the moral basis of their decision remain obscure. This ambiguity may have led to the restriction of cadaveric organ donation in Japan, while promoting living organ transplantation. The 2009 revision was made with the intention of increasing cadaveric organ donations. However, the revision further enhanced this ambiguity, by introducing “prioritized cadaveric donation”, and by widening the role of family decision-making. We suggest an interim conclusion: the problem is not whether the opt-in system or the opt-out system as a measure to respect the will of the deceased person will work better, but whether the fair distribution or the enlarged familial determination is better for overcoming the shortage of organs for transplantation. (Inoue and Hong, 2009)
  We published the surrogacy regulation studies in five countries. As of 2008, surrogacy is legal and openly practiced in various places; Japan, however, has no regulations or laws regarding surrogacy. This paper reports the situation of surrogacy in Japan and in five other regions (the USA, the UK, Taiwan, Korea and France) to clarify the pros and cons of prohibiting surrogacy, along with the problems and issues relating to surrogacy compensation. Not only in a country such as France that completely prohibits surrogacy within the country, but also in a country such as the UK that allows non-commercial surrogacy, infertile couples travel overseas for the purpose of surrogacy. In addition, some couples might seek underground surrogacy if the government prohibits surrogacy. If an intended parent couple and a surrogate make an agreement among themselves and then a problem occurs, they cannot ask for support from professionals or bring a case to court, as can be observed in South Korea and Taiwan. We also conclude that there is little difference between commercial surrogacy and non-commercial surrogacy in the absence of a clear definition of 'reasonable expenses.' In the UK, the law does not allow surrogates to receive compensation. However, in reality, there may be little difference between the amounts paid to surrogates for profit in the US and those paid to surrogates for reasonable expenses in the UK. We conclude that the issue of surrogacy demands further discussion in Japan. (Semba et al 2009)

Ethics and governance of several biomedical research projects

We supports some of the government-funded biomedical research projects, including “Project for realization of Personalized Medicine”, “Project for realization of Regenerative Medicine” and “Japan Eco and Child Study . Regarding ethical, legal and social issues, we educate researchers and coordinators, conduct satisfaction surveys to participants regarding informed consent process, and create communication papers to the public. We intend to connect participants and researchers by newsletters, café sciantifiques, symposia and so on.
Throughout these activities at the bench side, we generate some research agendas and conduct research. Our surveys showed that participants of Biobank Japan’s attitudes towards biobanking and pharmacogenomics. Our experiences may be useful to related issues on biobanking, public and participant relations, quality assurance of consent process and so on.

Bench-side ethics consultations for biomedical scientists

We also manage the Office of Research Ethics which provides research ethics consultation services for biomedical scientists. With a team-based approach, we support all research involving human subjects and samples in the IMSUT and make recommendations questions addressed by scientists and find unresolved questions. Throughout these consultations, we face several new bioethical challenges like human-animal chimeras, iPS cell banking and whole genome reseaquencing. Our paper shows that the IRB management and bench-side consultation are still not idealized and confused in Japan, even in the US (Kamirsato and Muto, in printing). We proposed a policy solution to develop standardization and quality control for institutional research ethics boards (or IRBs) in Japan. We also reconsider the idea of “Academic freedom is guaranteed”(Article 23) of the Constitution of Japan.

Medical science, social security and disability

We have conducted a comparative study on impact of regenerative medicine towards disability movement in East Asia. The implication of regenerative medicine may have conflict with the original idea of movement for seeking independent life of the disability. We have conducted some interviews with leaders of the disability movement in East Asia and compared their attitudes towards regenerative medicine. One the other hand, surveyed social security policy for the disabled, especially homecare services of the people with ALS.
We’re conducting a comparative study on prenatal testing between Taiwan and the UK. Both countries promote prenatal testing in the public health settings for early detection of the Down’s syndrome. We observe how the original idea of “Eugenics” has transformed and reflected to public policy in both countries.

Science communication via art—meaning of art, science, body and mind

As one of outreach activities, we have held our original science café series called as “Sci/Art Café” twice in 2008. Our original intent of “Sci/Art Café” is to promote communication between scientists and those who don’t have regular communication with science but love art. The 1st session called “Rhythm generated by network” was held in Shibuya during the 3rd World Rhythm Summit, supported by Dr. Atsuko Takamatsu (Waseda Univ.), Dr. Shin-ichi Nakagawa (RIKEN) and Dr. Hideaki Takeuchi (UT).
The 2nd session called “Doing science, doing art” was held on October 8th at the Medical Science Museum in the IMSUT, supported by Dr. Hideo Iwasaki (Waseda Univ.) and Dr. Yoichiro Murakami (JST).
Watanabe will organize the session for science and art at the 4S in August in Tokyo.
Via modern performing art, we had Dance workshops for the people with Huntington’s Disease and the people with ALS in June 2010 with Philippe Chehere by the Japan-France Sasagawa Foundation. Patients with Huntington’s Disease and ALS are suffering from their daily body change which’s going to be out of control. Throughout these performance and activities, we explore the meaning of science, art, body and mind.