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The Regulation of Genome Editing Technologies and New Methods of Germline Interventions in China

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Rechtliche Aspekte der Genom-Editierung an der menschlichen Keimbahn

Zusammenfassung

In a world’s first, scientists in China have reported gene editing in human embryos in 2015, while the United Kingdom and Sweden have both approved (but not yet conducted) such experiments only in 2016. Despite the fact that several countries have now allowed human embryo gene editing, researchers in China were also the first in the world who reported the use of CRISPR gene editing on normal (healthy) human embryos (previous experiments used embryos that could not be used for pregnancy purposes). This was reported by Chinese scientists on March 9, 2017. Chinese scientists announced the world’s first CRISPR clinical trial of a treatment for lung cancer in 2016. Even if this trial does not involve the genetic modification of human embryos (but the gene editing of somatic cells), it is another indicator that researchers in China have moved faster in the gene editing field than researchers in other countries.

This research is supported by the Fundamental Research Funds for the Central Universities (22120190125)

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Notes

  1. 1.

    Tang et al. (2017).

  2. 2.

    The article is first regulated in the 1982 version of Constitutional law of People’s Republic of China. The objective of this article is to protect people from insult and surveillance which had occurred during the Cultural Revolution. See Laifan (2008).

  3. 3.

    See Hong (2017).

  4. 4.

    Sibin (2006).

  5. 5.

    Laifan (2008).

  6. 6.

    Dayuan (2008).

  7. 7.

    Doering and Wahlberg (2007).

  8. 8.

    Warrell et al. (2009). http://www.mrc.ac.uk/Utillities/Documentrecord/index.htm?d=MRC006303.

  9. 9.

    Rosemann et al. (2017).

  10. 10.

    “人的体细胞治疗及基因治疗临床研究质控要点” Available via http://www.whbiobank.com/news2/3000.jhtml. Accessed 18 Feb 2019.

  11. 11.

    “人基因治疗研究和制剂质量控制技术指导原则” Available via http://www.sda.gov.cn/WS01/CL0237/15708.html, Accessed March 5 2018.

  12. 12.

    “人类遗传资源管理暂行办法” Available via http://www.most.gov.cn/bszn/new/rlyc/wjxz/200512/t20051226_55327.htm. Accessed 18 Feb 2019.

  13. 13.

    “涉及人的生物医学研究伦理审查办法” Available via http://www.nhfpc.gov.cn/fzs/s3576/201610/84b33b81d8e747eaaf048f68b174f829.shtml. Accessed 18 Feb 2019.

  14. 14.

    “人类辅助生殖技术规范”, “人类精子库基本标准和技术规范”, “人类辅助生殖技术和人类精子库伦理原则” Available via http://www.nhfpc.gov.cn/qjjys/s3581/200805/f69a925d55b44be2a9b4ada7fcdec835.shtml. Accessed 18 Feb 2019.

  15. 15.

    “人胚胎干细胞研究伦理指导原则” Available via http://www.most.gov.cn/fggw/zfwj/zfwj2003/200512/t20051214_54948.htm. Accessed 18 Feb 2019.

  16. 16.

    “干细胞临床研究管理办法(试行)” Available via http://www.nhfpc.gov.cn/qjjys/s3581/201508/28635ef99c5743e294f45e8b29c72309.shtml. Accessed 18 Feb 2019.

  17. 17.

    “生物技术研究开发安全管理办法” Available via http://www.most.gov.cn/mostinfo/xinxifenlei/fgzc/gfxwj/gfxwj2017/201707/t20170725_134231.htm. Accessed 18 Feb 2019.

  18. 18.

    “第一批高通量测序技术临床应用试点单位”, Available via http://www.alabmed.com/content-147-13970-1.html. Accessed 18 Feb 2019.

  19. 19.

    “海南省人民政府办公厅关于支持基因检测技术应用的意见”, Available via http://www.hainan.gov.cn/hn/zwgk/zfwj/bgtwj/201701/t20170119_2216866.html. Accessed 18 Feb 2019.

  20. 20.

    “专利审查指南(2010)” Available via http://www.sipo.gov.cn/zcfg/flfg/zl/bmgz/201501/t20150109_1057984.html. Accessed 18 Feb 2019.

  21. 21.

    The reexamination case FS17820, July 2 2009, 人多能干细胞生长和分化的技术 Available via http://app.sipo-reexam.gov.cn/reexam_out1110/searchdoc/decidedetail.jsp?jdh=FS17820&lx=fs. Accessed 18 Feb 2019.

  22. 22.

    The reexamination decision 89657, May 26 2015, 一种获得孤雌胚胎干细胞系的方法 Available via http://app.sipo-reexam.gov.cn/reexam_out1110/searchdoc/decidedetail.jsp?jdh=89657&lx=fs. Accessed 18 Feb 2019.

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Jiang, L. (2020). The Regulation of Genome Editing Technologies and New Methods of Germline Interventions in China. 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_6

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