Zusammenfassung
In Japan, biomedical researches are regulated by several statutes and several administrative guidelines. As to the regulation of embryo research, the Act on Regulation of Human Cloning Techniques regulates researches on cloned human embryos and certain embryos with both human and animal genetic elements. There are also several guidelines regulating specific area of research such as genome analysis, gene therapy clinical research, ES-cell research, and so on. However, there was no statute or guideline that regulates genomic improvement of embryos or germ-line cells in general. So, active discussions on the regulation of genome editing occurred in 2016, and temporarily the Expert Panel on Bioethics (EPB) and its subpart (“Task Force”) decided a policy to allow only one type of research using embryos genetically modified by genome-editing technology. The discussion on regulation system has been so confused, and that is probably a reflection of the cultural background of Japanese politics and the law.
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Notes
- 1.
English translation available at the Cabinet Secretariat’s website:http://www.cas.go.jp/jp/seisaku/hourei/data/htc.pdf. Accessed 19 Feb 2019.English translation offered by the Ministry of Justice:http://www.japaneselawtranslation.go.jp/law/detail/?id=112&vm=2&re=02. Accessed 19 Feb 2019.
- 2.
The Ministry of Health, Labor and Welfare gives an overview of its policy:http://www.mhlw.go.jp/english/policy/health-medical/medical-care/dl/150407-01.pdf. Accessed 19 Feb 2019.
- 3.
English translation available at the Ministry of Environment’s website:https://www.env.go.jp/en/laws/nature/act_csubdrlmo.pdf. Accessed 19 Feb 2019.English translation offered by the Ministry of Justice:http://www.japaneselawtranslation.go.jp/law/detail/?printID=&ft=1&re=02&dn=1&co=01&ia=03&x=0&y=0&ky=%E9%81%BA%E4%BC%9D%E5%AD%90&page=2&vm=02. Accessed 19 Feb 2019.
- 4.
Judgment on December 7, 2012, OGHSt Vol. 66, No. 12, p. 1337 ff. Available at http://www.courts.go.jp/app/hanrei_en/detail?id=1179. Accessed 19 Feb 2019.
- 5.
See the Cabinet Order for the Council for Science and Technology Policy of 2000:http://www.japaneselawtranslation.go.jp/law/detail/?id=1856&vm=02&re=02&new=1. Accessed 19 Feb 2019.
- 6.
The Council has also an English site to show its composition:http://www8.cao.go.jp/cstp/english/policy/panel.html. Accessed 19 Feb 2019.
- 7.
English translation of a former version is available at the website of the Ministry of Education, Culture, Sports, Science and Technology:http://www.lifescience.mext.go.jp/files/pdf/n796_00.pdf. Accessed 19 Feb 2019.The Ministry of Economy, Trade and Industry gives information on the reform in 2013:http://www.meti.go.jp/english/press/2013/0208_02.html. Accessed 11 Jan 2019.
- 8.
English translation is available on the website of the MHLW:http://www.mhlw.go.jp/file/06-Seisakujouhou-10600000-Daijinkanboukouseikagakuka/0000080278.pdf. Accessed 19 Feb 2019.
- 9.
English translation is available at:http://www.japaneselawtranslation.go.jp/law/detail/?id=2603&vm=02&re=02. Accessed 19 Feb 2019.
- 10.
English translation of the Guidelines on the Handling of Specified Embryos is available at the website of the MEXT:http://www.lifescience.mext.go.jp/files/pdf/n1564_02.pdf. Accessed 19 Feb 2019.
- 11.
English translation of its first version is available at the website of the MEXT:http://www.lifescience.mext.go.jp/files/pdf/n1567_01r2.pdf. Accessed 19 Feb 2019.
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Yonemura, S., Takayama, K., Tatsui, S. (2020). Report on the Regulation of Genome Editing in Japan. In: Taupitz, J., Deuring, S. (eds) Rechtliche Aspekte der Genom-Editierung an der menschlichen Keimbahn . Veröffentlichungen des Instituts für Deutsches, Europäisches und Internationales Medizinrecht, Gesundheitsrecht und Bioethik der Universitäten Heidelberg und Mannheim, vol 47. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-662-59028-7_10
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