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Rybakov O.Yu.

Kutafin Moscow State Law University (MSAL)

Dorodonova N.V.

Kutafin Moscow State Law University (MSAL)

Petrova R.E.

MIREA — Russian Technological University

Rybakova O.S.

Kutafin Moscow State Law University (MSAL)

Legal regulation of the human genome editing technologies application: international standards and the national practices

Authors:

Rybakov O.Yu., Dorodonova N.V., Petrova R.E., Rybakova O.S.

More about the authors

Journal: Russian Journal of Preventive Medicine. 2025;28(10): 7‑15

Read: 1619 times


To cite this article:

Rybakov OYu, Dorodonova NV, Petrova RE, Rybakova OS. Legal regulation of the human genome editing technologies application: international standards and the national practices. Russian Journal of Preventive Medicine. 2025;28(10):7‑15. (In Russ.)
https://doi.org/10.17116/profmed2025281017

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References:

  1. Broeders M, Herrero-Hernandez P, Ernst MPT, et al. Sharpening the Molecular Scissors: Advances in Gene-Editing Technology. iScience. 2020; 23(1):100789. https://doi.org/10.1016/j.isci.2019.100789
  2. Shi M, Shen Z, Zhang N, et al. CRISPR/Cas9 technology in disease research and therapy: a review. Sheng Wu Gong Cheng Xue Bao. 2021; 37(4):1205-1228. https://doi.org/10.13345/j.cjb.200401
  3. Chen C, Wang Z, Qin Y. CRISPR/Cas9 system: recent applications in immuno-oncology and cancer immunotherapy. Experimental Hematology and Oncology. 2023;12(1):95.  https://doi.org/10.1186/s40164-023-00457-4
  4. Villiger L, Joung J, Koblan L, et al. CRISPR technologies for genome, epigenome and transcriptome editing. Nature Reviews. Molecular Cell Biology. 2024;25(6):464-487.  https://doi.org/10.1038/s41580-023-00697-6
  5. Mir TUG, Wani AK, Akhtar N, et al. CRISPR/Cas9: Regulations and challenges for law enforcement to combat its dual-use. Forensic Science International. 2022;334:111274. https://doi.org/10.1016/j.forsciint.2022.111274
  6. Vseobshhaya deklaraciya prav cheloveka. Rezolyuciya 217 A (III) General`noj Assamblei OON ot 10 dekabrya 1948 g. Accessed September 04, 2025. (In Russ.). https://www.un.org/ru/documents/decl_conv/declarations/declhr.html
  7. Mezhdunarodnaya konvenciya o likvidacii vsex form rasovoj diskriminacii. Rezolyuciya 2106 (XX) General`noj Assamblei OON ot 21 dekabrya 1965 g. Accessed September 04, 2025. (In Russ.). https://www.un.org/ru/documents/decl_conv/conventions/raceconv.html
  8. Mezhdunarodny`j pakt ob e`konomicheskix, social`ny`x i kul`turny`x pravax, 16 dekabrya 1966 g. Rezolyuciya 2200 (XXI) General`noj Assamblei OON. Accessed September 04, 2025. (In Russ.). https://www.un.org/ru/documents/decl_conv/conventions/pactecon.shtml
  9. Konvenciya o likvidacii vsex form diskriminacii v otnoshenii zhenshhin. Rezolyuciya 34/180 General`noj Assamblei OON ot 18 dekabrya 1979 g. Accessed September 04, 2025. (In Russ.). https://www.un.org/ru/documents/decl_conv/conventions/cedaw.html
  10. Deklaraciya o pravax invalidov. Rezolyuciya 3447 (XXX) General`noj Assamblei OON ot 9 dekabrya 1975 g. Accessed September 04, 2025. (In Russ.). https://www.un.org/ru/documents/decl_conv/declarations/disabled.html
  11. Konvenciya o biologicheskom raznoobrazii (vmeste s «Opredeleniem i monitoringom», «Proceduroj arbitrazhnogo razbiratel`stva», «Soglasitel`noj proceduroj»), Rio-de-Zhanejro, 5 iyunya 1992. Accessed September 04, 2025. (In Russ.). https://www.un.org/ru/documents/decl_conv/conventions/biodiv.html
  12. Vseobshhaya deklaraciya o genome cheloveka i pravax cheloveka. General`naya konferenciya OON po voprosam obrazovaniya, nauki i kul`tury`, 11 noyabrya 1997 g. Accessed September 04, 2025. (In Russ.). https://www.un.org/ru/documents/decl_conv/declarations/human_genome.html
  13. Mezhdunarodnaya deklaraciya o geneticheskix danny`x cheloveka. Rezolyuciya General`noj konferencii YuNESKO po dokladu Komissii III na 20-m plenarnom zasedanii 16 oktyabrya 2003 g. Accessed September 04, 2025. (In Russ.). https://www.un.org/ru/documents/decl_conv/declarations/genome_dec.shtml
  14. Human genome editing: position paper. WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human. World Health Organization, 2021. Accessed September 04, 2025. https://www.readkong.com/page/recommendations-human-genome-editing-who-expert-advisory-7266507
  15. Evstifeeva EV, Dorodonova NV. International Legal Policy in the Field of Biomedical and Genomic Research. Pravovaja politika i pravovaja zhizn'. 2019;3:44-51. (In Russ.).
  16. Pestrikova AA., Kholopova EN. Risks of Genetic Editing of the Human Genome, Taking into Account the Recommendations of the World Health Organization. Pravovoe gosudarstvo: teorija i praktika. 2022;4(70):47-53. (In Russ.). https://doi.org/10.33184/pravgos-2022.4.7
  17. Pestrikova AA. Perspectives of Genome Editing in Humans: Risks, Problems and Legal Regulation. Medicinskaja jetika. 2022;10(2):28-33. (In Russ.). https://doi.org/10.24075/medet.2022.048
  18. Lapaeva VV. Biotechnological Human Improvement and the Problem of Dehumanization: Philosophical and Law Aspects. Trudy Instituta gosudarstva i prava Rossijskoj akademii nauk. 2022;17(3):11-35. (In Russ.). https://doi.org/10.35427/2073-4522-2022-17-3-lapaeva
  19. Federal’nyj zakon ot 05.07.1996 No. 86-FZ (red. ot 29.12.2022) «O gosudarstvennom regulirovanii v oblasti genno-inzhenernoj dejatel’nosti». Accessed September 04, 2025. (In Russ.). https://www.consultant.ru/cons/cgi/online.cgi?req=doc&base=LAW&n=471229&cacheid=5E35C9CADC95EB32083ACE51AE52A62D&mode=splus&rnd=4JCuSA#G0AY6wUS2ooV8PzN1
  20. Federal'nyj zakon ot 29.12.2022 No. 643-FZ «O vnesenii izmenenij v Federal'nyj zakon «O gosudarstvennom regulirovanii v oblasti genno-inzhenernoj dejatel'nosti». Accessed September 04, 2025. (In Russ.). https://www.consultant.ru/cons/cgi/online.cgi?req=doc&base=LAW&n=436209&cacheid=90D1AABA85A697DEF1FB2FF5EDCC35EC&mode=splus&rnd=4JCuSA#acrX6wUSiMYuorQg
  21. Federal’nyj zakon ot 21.11.2011 No. 323-F «Ob osnovah ohrany zdorov’ja grazhdan v Rossijskoj Federacii». Accessed September 04, 2025. (In Russ.). https://www.consultant.ru/cons/cgi/online.cgi?req=doc&base=LAW&n=502639&cacheid=248B31ED4C278271D73BD66D65A334A7&mode=splus&rnd=4JCuSA#VqaX6wUmiH6bWCs42
  22. Federal’nyj zakon ot 03.12.2008 No. 242-FZ (red. ot 08.08.2024) «O gosudarstvennoj genomnoj registracii v Rossijskoj Federacii». Accessed September 04, 2025. (In Russ.). https://www.consultant.ru/cons/cgi/online.cgi?req=doc&base=LAW&n=479642&cacheid=897EB502F81A384DBFCD28B707F2C168&mode=splus&rnd=4JCuSA#8RxW6wUC2NH7jHo51
  23. Federal'naja nauchno-tehnicheskaja programma razvitija geneticheskih tehnologij na 2019—2027 gody, utverzhdena Postanovleniem Pravitel'stva Rossijskoj Federacii ot 22.04.2019 No. 479. Accessed September 04, 2025. (In Russ.). https://www.consultant.ru/cons/cgi/online.cgi?req=doc&base=LAW&n=488333&cacheid=696770E7CAB8EEB14A05DAED5BD9E1CB&mode=splus&rnd=4JCuSA#P3kW6wUAzUyILjsB1
  24. Ukaz Prezidenta Rossijskoj Federacii ot 28.02.2024 No. 145 «O Strategii nauchno-tehnologicheskogo razvitija Rossijskoj Federacii». Accessed September 04, 2025. (In Russ.). https://www.consultant.ru/cons/cgi/online.cgi?req=doc&base=LAW&n=470973#TMjV6wU29dzNRhHl
  25. Cao C. China’s evolving biosafety/biosecurity legislations. Journal of Law and The Biosciences. 2021;8(1):lsab020. https://doi.org/10.1093/jlb/lsab020
  26. Ping J. From the Perspective of the Operational Mechanisms of Major National Bioethics Committees around the World, the Governance of Technological Ethics. China Reform [Zhongguo Gaige]. 2022;1:79. 
  27. Constitution of the People’s Republic of China 1982. Accessed September 04, 2025. https://www.npc.gov.cn/zgrdw/npc/zt/qt/gjxfz/2014-12/04/content_1888197.html
  28. Ishii T. Germline genome-editing research and its socioethical implications. Trends in Molecular Medicine. 2015;21(8):473-481.  https://doi.org/10.1016/j.molmed.2015.05.006
  29. Greely HT. CRISPR’d babies: human germline genome editing in the ‘He Jiankui affair’. Journal of Law and the Biosciences. 2019;6(1):111-183.  https://doi.org/10.1093/jlb/lsz010
  30. Song L, Joly Y. After He Jianku: China’s biotechnology regulation reforms. Medical Law International. 2021;21(2):174-192.  https://doi.org/10.1177/0968533221993504
  31. Xiaoxiao Zh. Research on the Ethical and Legal Coordination Mechanism of Offspring from the Perspective of Reproductive Genome Editing. Journal of Law and the Biosciences. 2023;45:88.  https://doi.org/10.1093/jlb/lsaf007
  32. Zhang S, Wang Y, Mao D, et al. Current trends of clinical trials involving CRISPR/Cas systems. Frontiers in Medicine. 2023;10:1292452. https://doi.org/10.3389/fmed.2023.1292452
  33. Bharathkumar N, Sunil A, Meera P, et al. CRISPR/Cas-Based Modifications for Therapeutic Applications: A Review. Molecular Biotechnology. 2022;64(4):355-372.  https://doi.org/10.1007/s12033-021-00422-8
  34. Liu G, Lin Q, Jin S, et al. The CRISPR-Cas toolbox and gene editing technologies. Molecular Cell. 2022;82(2):333-347.  https://doi.org/10.1016/j.molcel.2021.12.002
  35. Biosecurity Law of the People’s Republic of China, 2020. Accessed September 04, 2025. https://www.law.pkulaw.com/chinalaw/736cc84db120a6d5bdfb.html
  36. Xue Y, Shang L. Towards Better Governance on Biosafety and Biosecurity: China’s Advances and Perspectives in Medical Biotechnology Legislation. Frontiers in Bioengineering and Biotechnology. 2022;10:939295. https://doi.org/10.3389/fbioe.2022.939295
  37. Regulations on the Management of Human Genetic Resources 2019. Accessed September 04, 2025. www.gov.cn/zhengce/content/2019-06/10/content_5398829.html
  38. Implementation Rules for the Regulations on Human Genetic Resources 2023. Accessed September 04, 2025. https://www.gov.cn/xxgk/xinxifenlei/fdzdgknr/fgzc/bmgz/202306/t20230601_186416.html
  39. Measures for the Ethical Review of Biomedical Research Involving Humans 2007. Accessed September 04, 2025. https://www.nhc.gov.cn/wjw/gfxwj/200703/904f1976ed3d4da49eb56b0edf6e00b2.html
  40. Measures for the Ethical Review of Biomedical Research Involving Humans 2016. Accessed September 04, 2025. https://www.gov.cn/gate/big5/www.beijing.gov.cn/zhengce/zhengcefagui/qtwj/201610/t20161021_780889.html
  41. Liu S. Legal reflections on the case of genome-edited babies. Global Health Research and Policy. 2020;5:24.  https://doi.org/10.1186/s41256-020-00153-4
  42. Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings 2023. Accessed September 04, 2025. https://www.gov.cn/zhengce/zhengceku/2023-02/28/content_5743658.html
  43. Gang W, Peng H. China Releases Document on Ethics Review of Life Sciences: Comments and Compliance Guidelines. Biotechnology Law Report. 2023;42(3):149-153.  https://doi.org/10.1089/blr.2023.29308
  44. Zou Y, Li Y, Tao Y. Regulatory framework of human germline and heritable genome editing in China: a comparison with the United States and the United Kingdom. Journal of Law and the Biosciences. 2025;12(1):lsaf007. https://doi.org/10.1093/jlb/lsaf007
  45. Trial Measures for Scientific and Technological Ethics Review 2023. Accessed September 04, 2025. https://www.gov.cn/xxgk/xinxifenlei/fdzdgknr/fgzc/gfxwj/gfxwj2023/202310/t20231008_188309.html
  46. Measures for the Supervision and Inspection of Drug Clinical Trial Institutions (for Trial Implementation). 2023. Accessed September 04, 2025. https://www.gov.cn/xxgk/fgwj/xzhgfxwj/20231103175749117.html
  47. Ethical Guidelines for Human Genome Editing. 2024. Accessed September 04, 2025. https://www.gov.cn/kjbgz/202407/t20240708_191311.html
  48. Drug Administration Law of the People’s Republic of China. Accessed September 04, 2025. https://www.gov.cn/zgrdw/englishnpc/Law/2007-12/14/content_1384270.htm
  49. Law on the Progress of Science and Technology. 2021. Accessed September 04, 2025. https://www.gov.cn/xxgk/xinxifenlei/fdzdgknr/fgzc/flfg/202201/t20220118_179043.html
  50. Law of the People’s Republic of China on Basic Medical and Health Care and the Promotion of Health. 2021. Accessed September 04, 2025. https://en.gov.cn/2021-06/26/c_636455.html
  51. Regulations of the National Natural Science Foundation of China. Accessed September 04, 2025. https://www.gov.cn/english/site_1/policy/B3/2017/12-29/41.html
  52. Civil Code of the People’s Republic of China. Accessed September 04, 2025. https://www.gov.cn/xinwen/2020-06/01/content_5516649.html
  53. Criminal Law of the People’s Republic of China. Accessed September 04, 2025. https://www.en.gov.cn.cdurl.cn/2020-12/26/c_921604.html
  54. Wu L, Kong X. A study on the normative path of ethics review in China: based on the perspective of Panopticism. Frontiers in Medicine. 2023;10: 1268046. https://doi.org/10.3389/fmed.2023.1268046
  55. Romanovskiy GB, Romanovskaya OV. Law and Modern Medicine: Issues and Prospects. Izvestija vysshih uchebnyh zavedenij. Povolzhskij region. Obshhestvennye nauki. 2024;1(69):96-110. (In Russ.).
  56. Belova D.A. Protecting the Rights of Persons in Case of Injury Due to the Use of Gene Therapy. Vestnik Universiteta imeni O.E. Kutafina (MGJuA). 2021;1(11):151-159. (In Russ.). https://doi.org/10.17803/2311-5998.2021.87.11.151-159
  57. Chemeris AV, Anisimov VA, Aminev FG. Current Issues of Legal Regulation of Human Genome Databases Creating and Functioning. Pravovoe gosudarstvo: teorija i praktika. 2020;2(60):134-144. (In Russ.). https://doi.org/10.33184/pravgos-2020.2.12
  58. Kubyshkin AV, Grin OS, Shilyuk TO. Legislation of the Russian Federation in the Field of Protection of Genomic and Genetic Information in the Framework of Medical Diagnostics. Obshhaja reanimatologija. 2024; 20(3): 65-74. (In Russ.). https://doi.org/10.15360/1813-9779-2024-3-2395
  59. Pestrikova AA. Advantages and Risks of Editing of the Human Genome — Legal Aspect. Social'nye novacii i social'nye nauki. 2022;4(9):65-75. (In Russ.).
  60. Kopeikin PA. Bioethics, Law and Interests of Future Generations — Some Practical Areas of Common Interest. Medicinskaja jetika. 2024;12(1):42-46. (In Russ.). https://doi.org/10.24075/medet.2024.002
  61. Vasiliev SA, Osavelyuk AM, Burtsev AK, et al. Problems of Legal Regulation of Diagnostics and Editing of the Human Genome in the Russian Federation. Lex Russica. 2019;(6):71-79. (In Russ.). https://doi.org/10.17803/1729-5920.2019.151.6.071-079
  62. Konstitucija Rossijskoj Federacii: prinjata vsenarodnym golosovaniem 12 dekabrja 1993 g. S izmenenijami, odobrennymi v hode obshherossijskogo golosovanija 01 ijulja 2020 g. Accessed September 04, 2025. (In Russ.). https://www.publication.pravo.gov.ru/Document/View/0001202007040001
  63. Kostenkov KA, Komarova VV. Telemedicine and Human Rights: Risks of Interaction. Juridicheskaja nauka i praktika. 2024;2:29-33. (In Russ.).
  64. Grebenshchikova EG, Chuchalin AG. Bioethics in the 21st century: Challenges and Perspectives. Medicinskaja jetika. 2021;9(2):10-15. (In Russ.). https://doi.org/10.24075/medet.2021.012

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