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Regulation of Genome Editing in Human iPS Cells: Republic of Korea

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Regulation of Genome Editing in Human iPS Cells

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Abstract

Regarding the regulation of genome editing of human iPS cells in Korea, the Bioethics Act (2004) and the Advanced Regenerative Medicine Act (2019) are of importance. The Korean Bioethics Act is premised on the principle that any conduct interfering with human dignity is prohibited. It sets the legal framework for genome editing of human iPS cells. The new Advanced Regenerative Medicine Act primarily lays down accelerated approval and authorization procedures and, at the same time, improves the protection of patients and subjects.

The main public authority competent for research and application of cell/gene therapies is the Korean Ministry of Food and Drug Safety. In contrast, the highest administrative authority for research on human materials and embryos as well as for genetic diagnoses and gene therapies is the Korean Ministry of Health which is charged with matters of bioethics and life safety. In addition, the National Bioethics Committee which is directly responsible to the President decides on the guiding principles of bioethics and life safety policy. The new Advanced Regenerative Medicine Act provides for the establishment of a commission tasked with policy advice on advanced medicinal products and advanced biologics.

In Korea, genome editing of human iPS cells is regulated in detail by statutory law, specifically with regard to the respective phases: (1) planning of non-clinical research, (2) sampling of human materials, (3) non-clinical studies concerning reprogramming, genome editing and re-differentiation, (4) clinical trials of gene therapy and gene therapy medicinal products, and (5) manufacturing and placing on the market of gene therapy medicinal products.

Personal data of patients and subjects may only be transmitted on the basis of written consent by the person concerned. This right to self-determination is enshrined in the general right to personality as guaranteed in the constitution.In accordance with the Korean Bioethics Act, direct interventions into the germ line are prohibited, even if they serve the purpose of curing a hereditary disease because, in accordance with the current state of science and technology, the risks of such interventions cannot be determined precisely.

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Notes

  1. 1.

    Cf. Korean Ministry of Food and Drug Safety (2019a).

  2. 2.

    An English translation of the Act as last amended on 12 December 2017 is available via https://www.law.go.kr/LSW/lsInfoP.do?lsiSeq=199534&viewCls=engLsInfoR&urlMode=engLsInfoR#0000.

  3. 3.

    Cf. Art. 10 Constitution of the Republic of Korea of 29 October 1987, available via http://www.law.go.kr/lsInfoP.do?lsiSeq=61603&urlMode=engLsInfoR&viewCls=engLsInfoR#.

  4. 4.

    Cf. the Act on Medical Service of 20 March 1962, last amended on 27 August 2019; see the English translation of this Act as last amended on 30 November 2016: http://www.law.go.kr/lsInfoP.do?lsiSeq=183558&urlMode=engLsInfoR&viewCls=engLsInfoR#0000.

  5. 5.

    Cf. the Act on Pharmaceutical Affairs of 28 December 1953, last amended on 15 January 2019; see the English translation of this Act as last amended on 2 December 2016: http://www.law.go.kr/lsInfoP.do?lsiSeq=188093&urlMode=engLsInfoR&viewCls=engLsInfoR#0000.

  6. 6.

    Cf. § 25 Act on Government Organization of 23 March 2013, last amended on 8 June 2018; see the English translation of this Act as last amended on 1 January 2016: http://www.law.go.kr/lsInfoP.do?lsiSeq=177655&urlMode=engLsInfoR&viewCls=engLsInfoR#0000.

  7. 7.

    Cf. §§ 26 and 38 Government Organization Act (see fn. 6).

  8. 8.

    Cf. §§ 8, 10 et seqq., 22, 29 et seq., 33 et seq., 36, 41, 48 et seqq., 54 et seqq., 60 et seqq. Bioethics Act (see fn. 2).

  9. 9.

    Six ministers (of Education, Science and ICT, Justice, Trade and Industry, Health and Welfare, Gender Equality and Family), up to seven experts (in life sciences, medicine, social sciences) and up to seven representatives of society (religions, ethics, law, NGOs).

  10. 10.

    Cf. §§ 7 et seqq. Bioethics Act (see fn. 2).

  11. 11.

    Cf. § 7 Advanced Regenerative Medicine Act.

  12. 12.

    Cf. § 7 par. 2 and 3 Advanced Regenerative Medicine Act.

  13. 13.

    Cf. § 7 par. 1 Advanced Regenerative Medicine Act.

  14. 14.

    Cf. § 36 Bioethics Act (see fn. 2).

  15. 15.

    Cf. § 11 Bioethics Act (see fn. 2).—This does not apply if the research purpose is changed. In practice, however, such cases are very rare because the purpose of the research is formulated very comprehensively from the outset, e.g. curing hereditary or serious diseases or improving the health care system.

  16. 16.

    Cf. § 10 par. 2 Bioethics Act (see fn. 2) and § 5 ministerial ordinance for implementing the Bioethics Act.

  17. 17.

    Cf. § 12 par. 1 no. 2 Bioethics Act (see fn. 2).

  18. 18.

    Cf. § 37 par. 1 Bioethics Act (see fn. 2) and § 34 ministerial ordinance for implementing the Bioethics Act.

  19. 19.

    Cf. Form No. 34 in the annex to the ministerial ordinance for implementing the Bioethics Act.

  20. 20.

    Cf. § 37 par. 2 in conjunction with § 16 par. 2 Bioethics Act (see fn. 2).

  21. 21.

    Cf. § 37 par. 3 Bioethics Act (see fn. 2).

  22. 22.

    The Korean legislature defines the term “advanced regenerative medicine” as cell therapies, gene therapies and tissue engineering, cf. § 2 no 1 Advanced Regenerative Medicine Act.

  23. 23.

    Cf. § 15 Advanced Regenerative Medicine Act.

  24. 24.

    Cf. § 16 Advanced Regenerative Medicine Act.

  25. 25.

    Cf. § 5 par. 4 no. 4 ministerial ordinance on the authorisation of clinical trials of medicinal products of 3 December 2002, last amended on 24 May 2019; § 6 ministerial ordinance on testing of biologics for marketing authorisation of 23 May 2003, last amended on 9 September 2019.

  26. 26.

    Cf. European Medicines Agency, Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells (13 April 2012), EMA/CAT/GTWP/671639/2008, https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-non-clinical-clinical-aspects-medicinal-products-containing-genetically-modified_en.pdf.

  27. 27.

    Cf. Food and Drug Administration, Guidance for Industry, Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products (August 2015), https://www.fda.gov/media/89036/download.

  28. 28.

    Cf. § 2 No 16 and § 47 par. 2 Bioethics Act (see fn. 2). The Korean legislature differentiates between cell therapy and gene therapy to the effect that cell therapy only applies if there has been no genetic manipulation.

  29. 29.

    Cf. § 47 par. 1 Bioethics Act (see fn. 2).

  30. 30.

    Cf. § 47 par. 3 Bioethics Act (see fn. 2).

  31. 31.

    Cf. § 10 par. 1 Advanced Regenerative Medicine Act.

  32. 32.

    Cf. § 10 par. 2 Advanced Regenerative Medicine Act.

  33. 33.

    The Korean legislature defines the term “advanced biopharmaceuticals” as cell therapy products, gene therapy products and tissue engineering products as well as biopharmaceuticals physically and/or chemically fused or converged with a medical device, cf. § 2 no. 5 Advanced Regenerative Medicine Act.

  34. 34.

    Cf. § 13 Advanced Regenerative Medicine Act.

  35. 35.

    Cf. § 13 par. 2 Advanced Regenerative Medicine Act. The members of this commission are appointed by the Minister of Health after consultation with the Minister of Food and Drug Safety.

  36. 36.

    Cf. § 13 par. 1 Advanced Regenerative Medicine Act.

  37. 37.

    Cf. § 12 par. 1 Advanced Regenerative Medicine Act.

  38. 38.

    Cf. § 14 par. 2 Advanced Regenerative Medicine Act.

  39. 39.

    Cf. § 14 par. 1 Advanced Regenerative Medicine Act.

  40. 40.

    Cf. § 14 par. 3 Advanced Regenerative Medicine Act.

  41. 41.

    Cf. § 2 no. 3 Advanced Regenerative Medicine Act.

  42. 42.

    Cf. § 15 Advanced Regenerative Medicine Act.

  43. 43.

    Cf. § 10 par. 3 Advanced Regenerative Medicine Act.

  44. 44.

    Cf. § 11 par. 1 Advanced Regenerative Medicine Act.

  45. 45.

    Cf. § 11 par. 4 Advanced Regenerative Medicine Act.

  46. 46.

    Cf. § 19 par. 1 Advanced Regenerative Medicine Act.

  47. 47.

    Cf. § 19 par. 2 Advanced Regenerative Medicine Act.

  48. 48.

    Cf. § 23 par. 1 Advanced Regenerative Medicine Act.

  49. 49.

    Cf. § 23 par. 2 Advanced Regenerative Medicine Act.

  50. 50.

    Cf. § 23 par. 2 Advanced Regenerative Medicine Act.

  51. 51.

    Cf. § 23 par. 3 Advanced Regenerative Medicine Act.

  52. 52.

    Cf. § 23 par. 5 Advanced Regenerative Medicine Act.

  53. 53.

    Cf. § 27 par. 1 Advanced Regenerative Medicine Act.

  54. 54.

    Cf. § 32 par. 1 and 2 Advanced Regenerative Medicine Act.

  55. 55.

    Cf. § 32 par. 3 Advanced Regenerative Medicine Act.

  56. 56.

    Cf. § 36 Advanced Regenerative Medicine Act.

  57. 57.

    Cf. the Act on Rare Disease Management of 29 December 2015, last amended on 30 April 2019; see the English translation of this Act as last amended on 29 December 2015: http://www.law.go.kr/lsInfoP.do?lsiSeq=178255&urlMode=engLsInfoR&viewCls=engLsInfoR#0000.

  58. 58.

    Cf. the Act on Infectious Disease Control and Prevention of 28 February 1957, last amended on 31 December 2018; see the English translation of this Act as last amended on 2 December 2016: http://www.law.go.kr/lsInfoP.do?lsiSeq=188080&urlMode=engLsInfoR&viewCls=engLsInfoR#0000.

  59. 59.

    Cf. § 36 par. 2 Advanced Regenerative Medicine Act.

  60. 60.

    Cf. § 36 par. 3 Advanced Regenerative Medicine Act.

  61. 61.

    Cf. §§ 16, 18, 24, 37, 42, 51 Bioethics Act (see fn. 2).

  62. 62.

    Cf. §§ 11, 16, 29 Advanced Regenerative Medicine Act.

  63. 63.

    Cf. the Act on Personal Information Protection of 29 March 2011, last amended on 26 July 2017; see the English translation of this Act as last amended on 26 July 2017: http://www.law.go.kr/lsInfoP.do?lsiSeq=195062&urlMode=engLsInfoR&viewCls=engLsInfoR#0000.

  64. 64.

    Cf. § 18 par. 1 Bioethics Act (see fn. 2).

  65. 65.

    Cf. § 18 par. 2 Bioethics Act (see fn. 2).

  66. 66.

    Cf. Art. 10 and 17 Korean Constitution (see fn. 3).

  67. 67.

    Cf. § 47 par. 3 Bioethics Act (see fn. 2).

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Authors and Affiliations

  1. Chungnam National University, Graduate School of Law, Daejeon, Republic of Korea

    Yu-Cheol Shin

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  1. Faculty of Law, University of Passau, Passau, Germany

    Hans-Georg Dederer

  2. Faculty of Law, University of Passau, Passau, Germany

    Gregor Frenken

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Shin, YC. (2022). Regulation of Genome Editing in Human iPS Cells: Republic of Korea. In: Dederer, HG., Frenken, G. (eds) Regulation of Genome Editing in Human iPS Cells. Springer, Cham. https://doi.org/10.1007/978-3-030-93023-3_8

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  • DOI: https://doi.org/10.1007/978-3-030-93023-3_8

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