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Genome Editing Regulation in Russia

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Rechtliche Aspekte der Genom-Editierung an der menschlichen Keimbahn

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Zusammenfassung

As for now, Russia has no particular law that regulates genome editing as such. Nevertheless, there are a number of instruments that can be considered applicable to this technology taking into account that genome editing is one of the gene therapy methods thus falling into the wide range of engineering technics used in medicine, biology and in medical biology (biomedicine) – i.e. spheres that are more or less regulated in Russia either nationally or through supranational treaties or recognition of international standards.

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Notes

  1. 1.

    Federal Law No. 61-FZ “On Circulation of Medicaments” of April 12, 2010.

  2. 2.

    See f.i. Methodical Recommendations for the Developers’ and Producers’ of Medicaments that Circulate on the Territory of the Russian Federation on the Preparation of Periodical Reports on the Medicaments Safety (approved by Roszdravnadzor on June 04, 2013); Order of the Federal Service for Veterinary and and Phyto-Sanitary Supervision (Rosselkhoznadzor) of October 18, 2016 No. 755; Order of the Ministry for Industry and Commerce of the Russian Federation (Minpromtorg) of February 04, 2016; Resolution of the Government of the Russian Federation of April 16, 2012 No. 317, etc.

  3. 3.

    Comprehensive Program of Biotechnologies Development in the Russian Federation Up to the Year 2020 – VP-P8-2322, approved by the Government of the Russian Federation on April 24, 2012, document No. 1853p-P8.

  4. 4.

    See: Article 2 of the Federal Law No. 86-FZ “On State Regulation in the Field of Genetic Engineering Activity” of July 05, 1996.

  5. 5.

    Article 5(2) of the Federal Law No. 86-FZ.

  6. 6.

    Article 6(1) of the Federal Law No. 86-FZ.

  7. 7.

    Development of biotechnologies in Russia goes with accelerated pace. Delovye Novosti (17 March 2017).

  8. 8.

    Order of the Government of the Russian Federation No. 2237 of December 03, 2012 On the Approval of the Program of Fundamental Scientific Research of State Academies of Sciences for 2013–2020.

  9. 9.

    Paragraph 60 of the Annex No. 2 (Basic Expected Results of the fulfilment of the Plans… for the year 2013 and Plans to Conduct Fundamental Scientific Research and Explorative Scientific Research in the in the Scientific Organizations under the Jurisdiction of FASO for years 2014–2020) of the Order of the Government of the Russian Federation No. 2237-r of December 03, 2012 On the Approval of the Program of the Fundamental Scientific Research of State Academies of Sciences for the years 2012–2020. Paragraph 60 speaks about cell biology and theoretical foundations of cell technologies. The expected result in this field is formulated as “to develop technology of genetic sensitization and to transfer it to the technological basis of artificial chromosome as a platform for gene therapy and safeguarding safety of tissue substitution therapy based on embryonic stem cells and induced pluripotent stem cells”.

  10. 10.

    Section 3 of the Annex No. 7 to the Prognosis of the Scientific and Technical Development of the Russian Federation for the period till the year 2030. Approved by the Government of the Russian Federation (no date, no number); Annex No. 2 of the Oder of the Minzdrav of Russian Federation of April 30, 2013 No. 281 On the Approval of the Scientific Platforms of Medical Sciences.

  11. 11.

    See for instance: Markina (22 April 2016).

  12. 12.

    Moscow Institute of Physics and Technology (State University), the leading Russian university in the field of physics and related sciences. University website: https://mipt.ru/english/about/about-mipt/. Accessed 19 Feb 2019.

  13. 13.

    Shutova MV et al. (2016), 986–997.

  14. 14.

    On the State of the Sanitary and Epidemiology Well-being of the Population of the Russian Federation in 2016: Governmental Report. Moscow: Federal Service for Supervision in the Field of Consumer Rights Protection and Human Well-being 2017, p. 154.

  15. 15.

    Iliya Mazunin Won the Contest of the Russian Scientific Fund to conduct scientific research in the field of genome editing. July 06, 2017. Baltic Federal University website, https://www.kantiana.ru/news/143/211394/. Accessed 19 Feb 2019.

  16. 16.

    The “Human Stem Cells Institute” is a private company registered in the form of a public corporation. Official website of the Institute: https://eng.hsci.ru/home (English). Accessed 19 Feb 2019.

  17. 17.

    Certificate of Registration No. LP-000671 of September 28, 2011. https://hsci.ru/content/files/RU_RU_RU.pdf. Accessed 19 Feb 2019.

  18. 18.

    Gene Therapy: Neovasculgen. HSCI website: https://eng.hsci.ru/products/neovasculgen. Accessed 19 Feb 2019.

  19. 19.

    Ibid. See also: Human Stem Cells Institute (12 October 2016); Human Stem Cells Institute (01 February 2017).

  20. 20.

    Reiter and Babitzkiy (26 January 2015).

  21. 21.

    To the moment EAEU unites five countries: Russia, Belarus, Armenia, Kazakhstan and Kyrgyzstan.

  22. 22.

    Decision of the Council of the Euro-Asian Economic Commission No. 83 of November 03, 2016 On the Approval of the Rules on Pharmaceutical Inspections Implementation.

  23. 23.

    Decision of the Council of the Euro-Asian Economic Commission No. 77 of November 03, 2016 On the Approval of the Rules of Proper Production Practice of the Euro-Asian Economic Union.

  24. 24.

    Treaty on the Euro-Asian Economic Union of May 29, 2014.

  25. 25.

    Agreement on Single Principles and Rules on Medicaments Circulation in the Euro-Asian Economic Union of December 23, 2014.

  26. 26.

    Decision of the Council of the Euro-Asian Economic Commission No. 78 of November 03, 2016 On the Approval of the Rules on the Registration and Expert Assessment of Medicaments for Medical Use.

  27. 27.

    See f.i.: Romanovskiy G,B., Romanovskaya O.V. Biomedical Technologies as an Object of Legal Regulation. Public Legal Research: electronic journal. 2014. No. 1. Pp. 1–28; Vasiliev A.V., Davydov D.V., Kiseleva E.V., Marchenko M.G. Legal Aspects of Research in the Field of Cell Technologies and Their Adoption in Clinical Practice. Meditzinskoe Pravo [Medical Law]. 2010. No. 3. Pp. 9–13, etc.

  28. 28.

    Paragraph 4(2) of the Article 1349 of Part 4 of the Civil Code of the Russian Federation.

  29. 29.

    Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions. Portal on EU law “EUR-Lex”. Available via http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31998L0044. Accessed 19 Feb 2019.

  30. 30.

    See f.i.: Commentary to the Civil Code of the Russian Federation. Ed. by: L.A. Trakhtengertz. T. 2. Moscow: INFRA-M, 2016.

  31. 31.

    Part 4 of the Civil Code devoted to IP rights was adopted at the end of 2006, i.e. just 11 years ago, and it still evolves being amended 2–5 a year, with the last amendment for December 2017 issued in July 2017.

  32. 32.

    Resolution of the Chamber on Patent Disputes of November 27, 2015 on the rejection of patent issuance (annex to the Decision of Federal Service on Intellectual Property (Rospatent) on the application No. 2013100565/10 of April 11, 2016). The Resolution related to the patent application for the invention titled “Method of cybrid production with the human genome” and was issued on the objection to the initial Rospatent Decision on this application (of May 06, 2014) from the two academic institutions of the Russian Academy of Sciences.

  33. 33.

    Ethical issues in medical and biological research.

  34. 34.

    See f.i.: Andorno (2002), 959–963.

  35. 35.

    UNESCO 30 C/Resolution 23. Records of the General Conference 30th Session: Paris, 26 October to 17 November 1999. Vol. 1: Resolutions. Paris: UNESCO, 2000. Pp. 60–61. Available via http://unesdoc.unesco.org/images/0011/001185/118514e.pdf. Accessed 19 Feb 2019.

  36. 36.

    UNESCO 33 C/Resolution 15. Records of the General Conference 33rd Session. Paris, 3–21 October 2005. Vol. 1: Resolutions. Paris: UNESCO, 2005. Available via http://unesdoc.unesco.org/images/0014/001428/142825e.pdf. Accessed 19 Feb 2019.

  37. 37.

    Resolution 1993/91 “Human Rights and Bioethics” (UN, 1993), Resolution 1997/71 “Human Rights and Bioethics” (UN, 1997), Resolution A/RES/53/152 “The Human Genome and Human Rights” (UN, 1998); Resolution 25 C/7.3 “Human rights and scientific and technological „progress“ (UNESCO, 1989), Resolution 27 C/5.15 “Preparation of an international instrument for the protection of the human genome” (UNESCO, 1993), Resolution 28 C/2.2 “Drawing up of an international declaration on the human genome and the protection of human rights” (UNESCO, 1995), Resolution 29 C/I7 “Implementation of the Universal Declaration on the Human Genome and Human Rights” (UNESCO, 1997), etc.

  38. 38.

    National bioethics committees in action (2010), p. 24.

  39. 39.

    Bioethics and Human Rights (13–15 May 1991).

  40. 40.

    Ibid. p. 32.

  41. 41.

    See f.i.: course on “Bioethics with elements of biosafety and bioprotection” in the Novosibirsk National Research State University for bachelors program in biology (Available via http://www.nsu.ru/xmlui/bitstream/handle/nsu/6730/%D0%B1%D0%B8%D0%BE%D1%8D%D1%82%D0%B8%D0%BA%D0%B0%20%28%D0%B1%D0%B0%D0%BA%D0%B0%D0%BB%D0%B0%D0%B2%D1%80%D1%8B%29.docx. Accessed 19 Feb 2019.), course on “Bioethics” in the Moscow State University of Medicine and Dentistry for bachelors program in social work (Available via http://www.msmsu.ru/userdata/manual/doc/fac/soc_rab/УМК%20Биоэтика.doc. Accessed 19 Feb 2019.), etc.

  42. 42.

    Apresyan und Shamov (2006), pp. 137–141.

  43. 43.

    Resolution No. 32–10 on the Cooperation of the States Participating in CIS on the Harmonization of the Medical Education with the UNESCO Educational Program on Bioethics. The Interparliamentary Assembly of Member Nations of the Commonwealth of Independent States (IPA CIS). Available via http://iacis.ru/upload/iblock/08d/rec_14_05_09.pdf. Accessed 19 Feb 2019. See also: Kubar (2010).

  44. 44.

    Federal State Educational Standard for Higher Professional Education for the Degree in Biology (approved by the Order of the Ministry of Education and Science of the Russian Federation No. 101 of 04.02.3010.

  45. 45.

    Ivanov and Yudin: Russian National Committee on Bioethics (1998).

  46. 46.

    Yudin (2000), pp. 237–241.

  47. 47.

    General Assembly Adopts United Nations Declaration on Human Cloning by Vote of 84-34-37. General Assembly Plenary. GA/10333 82nd Meeting (AM), 8 March 2005. United Nations Press, 2005. Available via https://www.un.org/press/en/2005/ga10333.doc.htm. Accessed 19 Feb 2019.

  48. 48.

    National bioethics committees in action (2010), p. 22.

  49. 49.

    “Bioethical Forum” website. Created with the financial support of the UNESCO Bureau in Moscow. Available via http://www.bioethics.ru. Accessed 19 Feb 2019.

  50. 50.

    Unfortunately, it is obvious from the website that its best days fall on the same year 2005 and did not last for long. For instance, the last messages on the forum are of 2006, and the one and the only issue of the Bulletin of the Russian Bioethics is of 2007. However, its main news section has been regularly updated till August 2017 when prof. Yudin passed away. Now the future of this online project remains unclear.

  51. 51.

    Establishing Bioethical Committees (2005).

  52. 52.

    There were two decisions on its creation – one made by UNESCO in 2006, and another – by the Russian governmental authority in 2007: Decision of the General Meeting of the National Commission of the Russian Federation for UNESCO of April 25, 2006; Order of the Federal Service for Supervision in the field of healthcare (Roszdravnadzor) No. 2314-Pr/07 of August 17, 2007.

  53. 53.

    Schmidt et al. (2010).

  54. 54.

    Local Ethical Committee. Kazan State Medical University. Available via http://www.kgmu.kcn.ru/science-and-innovation/lokalnyj-eticheskij-komitet. Accessed 19 Feb 2019.

  55. 55.

    Yudin (2007).

  56. 56.

    Kubar. (2007).

  57. 57.

    Yudin (date unknown).

  58. 58.

    National bioethics committees in action (2010) p. 22.

  59. 59.

    The Oviedo Convention: protecting human rights in the biomedical field. Council of Europe. Available via https://www.coe.int/ru/web/bioethics/oviedo-convention. Accessed 19 Feb 2019.

  60. 60.

    Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (ETS No. 168, 1998), Additional Protocol to the Convention on Human Rights and Biomedicine concerning Transplantation of Organs and Tissues of Human Origin (ETS No. 186, 2002), Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (CETS No. 195, 2005), Additional Protocol to the Convention on Human Rights and Biomedicine concerning Genetic Testing for Health Purposes (CETS No. 203, 2008). See all protocols here: https://www.coe.int/en/web/conventions/full-list/-/conventions/webContent/en_GB/7780840. Accessed 19 Feb 2019.

  61. 61.

    National bioethics committees in action (2010), p. 23. It is also mentioned that the situation with the protocol on human cloning is different to some extent, but it lies somewhat beyond the scope of this research and besides the result is actually the same – that protocol is not ratified as well, though laws banning this technology were enacted in 2002 (expired in 2007) and in 2010 (now the expiration date is the date when a federal law on the usage of human cloning technologies comes in force) – Federal Law No. 30-FZ of 29.03.2010, Available via https://rg.ru/2010/03/31/klon-dok.html. Accessed 19 Feb 2019.

  62. 62.

    Federal Law No. 180-FZ “On Biomedical Cellular Products” of 23.06.2016 (came into effect on 01.01.2017 except paragraphs 2 and 5(2) of the article 35 that come into effect on 01.01.2018).

  63. 63.

    Meditzinskii Vestnik, Outstripping legislation. [Medical Bulletin]. 2016. No. 4 (725). Pp. 20.

  64. 64.

    If we compare article 5 of the CIS Model Law and article 31 of the Law on Biomedical Cellular Products, we may see that despite elaborating the single guaranteed patient’s right of this kind stated in the CIS Model Law – the right for “receiving full and objective information about the nature of biomedical research in a form accessible to a potential participant of the research” (art. 5 of the Model Law), - LBCP ends up guaranteeing less to the potential participant through giving a clear and closed list of 7 types of information that shall be given to the patient in written form in case (s)he participates in clinical research of a biomedical cell product.

  65. 65.

    Art. 24 and 25 of the CIS Model Law.

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  1. National Research University Higher School of Economics, Moscow, Russia

    Daria V. Chernyaeva

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  1. Daria V. Chernyaeva
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Correspondence to Daria V. Chernyaeva .

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  1. Institut für Medizinrecht, Universität Mannheim, Mannheim, Germany

    Jochen Taupitz

  2. Institut für Medizinrecht, Universität Mannheim, Mannheim, Germany

    Silvia Deuring

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Chernyaeva, D.V. (2020). Genome Editing Regulation in Russia. 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_15

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