Amisha Agrawal¹, Anya Chabria², Clarise Han³, Mori Ono⁴, Haris Rana⁵, Tyler Shern⁶, Lillian Sun⁷, Stephanie Tarrab⁶, Daniel Wang³, Serena Yang⁸, Brooke Ellison⁹

¹Emory University, Atlanta, GA 30322, ²Duke University, Durham, NC 27708, ³Massachusetts Institute of Technology, Cambridge, MA 02138, ⁴Princeton University, Princeton, NJ 08544, ⁵Southside High School, Fort Smith, AR 72903, ⁶Columbia University, New York, NY 10027, ⁷Thomas Jefferson High School for Science and Technology, Alexandria, VA 22312, ⁸Dougherty Valley High School, San Ramon, CA 94582,  ⁹Center for Compassionate Care, Medical Humanities, and Bioethics, Health Science Center, Stony Brook University, Stony Brook, NY 11794

*Editors: Shivek Narang, Serena Yang, Jessica Guo

Although Japanese culture and religion are conventionally viewed as placing little value on the embryo, different studies indicate wide-ranging perspectives on the matter.^[1] The bioethics committee of the Council for Science and Technology Policy (CSTP) considers the embryo to be a “germ of life,” which implies that embryo destruction may be equated to killing a potential human, but allows unused embryos from IVF for therapeutic use. Additionally, researchers were instructed to “respect the embryo,” but the CSTP did not clarify how this phrase was to be interpreted. There is little public debate on the topic of human embryonic stem cell research, despite attempts by the Japanese government to encourage conversation. Further debate could potentially encourage the general population to donate embryos and support human embryonic stem cell (hESC) research.^[2] This study will examine the development of these stem cell research policies as well as public opinion in Japan.

Currently, the Ministry of Education, Culture, Sport, Science and Technology (MEXT) is working with the Ministry of Health, Labour and Welfare (MHLW) to set guidelines for research into stem cells; biomedical research is divided into basic and clinical research, which are regulated by the MEXT and MHLW respectively.^[3] Japan enacted several laws between 2000 and 2009, including regulations on cloning technology for humans, ethical guidelines on human adult stem cells, and revisions to these aforementioned policies. Although the expert panel on bioethics in the Japanese Cabinet influences the ethical guidelines passed by MEXT, there has been no coherent development of an ethical direction or more concrete standards in the field, as MHLW has not sought the advice of the expert panel so far.^[4]

Many problems are present in Japanese stem cell research due to the gaps in policies. Stem cell companies are bypassing rigorous testing of their therapies in order to get them on the market as soon as possible, which reduces the effectiveness of their treatments. Scientists suspect that the efficacy of stem cell treatments used in many commercial therapies is fabricated as a marketing tactic. 10 stem cell or spinal cord scientists not involved with STR01 (Stemirac) stated that evidence for the treatment’s efficacy is insufficient.^[5]

Another problem is the difference between public and scientific perceptions and expectations of stem cell research. This is made clear in a survey conducted by Japanese universities that included 2160 public responses and 1115 responses from members of the Japanese Society for Regenerative Medicine (JSRM).^[6] The main areas that the public was interested in that differed from JSRM members were the effectiveness of regulation (50.5%), probabilities of potential risks and accidents (33.5%), and clarification of responsibility and liability (32.2%). The main areas JSRM members were interested in were scientific validation (55%) and the necessity of research (36.3%). Gaps in the expectations and usage of regenerative medicine were also shown through this survey. The general public expected regenerative medicine to be ready for use earlier than JSRM members.^[6]

In the future, the different branches of the Japanese government involved in bioethics and stem cell regulation should cooperate in directing a clearer set of guidelines for stem cell usage in research and advanced clinical trials. Furthermore, there is still lots of room for improvement for Japan’s rules and regulations on stem cell research.

 

References

[1] Sleeboom-Faulkner, Margaret. “Contested Embryonic Culture in Japan—Public Discussion, and Human Embryonic Stem Cell Research in an Aging Welfare Society.” Medical Anthropology, vol. 29, no. 1, 2010, pp. 44–70., doi:10.1080/01459740903304256.

[2] Sleeboom-Faulkner, Margaret. “Debates on Human Embryonic Stem Cell Research in Japan: Minority Voices and Their Political Amplifiers.” Taylor & Francis, 8 Mar. 2008, www.tandfonline.com/doi/abs/10.1080/09505430801915455.

[3] “Act on Regulation of Human Cloning Techniques.” 2000. PDF file.

[4] Ministry of Education, Culture, Sports, Science and Technology, Japan, Guidelines for Handling of a Specified Embryo (2001)

[5] Cyranoski, David. “The Potent Effects of Japan’s Stem-Cell Policies.” Nature News, Nature Publishing Group, 25 Sept. 2019, www.nature.com/articles/d41586-019-02847-3.

[6] Shineha, Ryuma et al. “A Comparative Analysis of Attitudes on Communication Toward Stem Cell Research and Regenerative Medicine Between the Public and the Scientific Community.” Stem cells translational medicine vol. 7,2 (2018): 251-257. doi:10.1002/sctm.17-0184