Available in Russian
Author: Alexandra Troitskaya
Keywords: human genome; genetic editing; CRISPR-Cas9; status of the embryo; human dignity; health care
The emergence and improvement of human genome editing technology raises a number of significant legal questions about the prospects for its regulation. Some types of artificial modification of the human genome (and above all those that can be inherited) are currently blocked in many countries. The author attempts to understand in detail the reasons for this and whether it might have a more pragmatic alternative. To do this, the article presents the biotechnological aspect of human genome editing and its purposes; an outline of the modern legal framework for editing; and a summary of key medical, ethical and social concerns and possible ways out of the ideological impasse, deconstructing at least some of these concerns. The article takes into account not only the legal and ethical constructions that shape the relevant discussion but also the essence of editing in the categories of molecular biology. In addition, the analysis considers previously adopted reproductive and genetic technologies whose practice can help crystallize attitudes towards editing the human genome. The result of the study is a set of specific, practical proposals for legal regulation of human genome editing technology.
About the author: Alexandra Troitskaya – Doctor of Sciences in Law, Professor of the Constitutional and Municipal Law Department, Faculty of Law, Lomonosov Moscow State University, Moscow.
Citation: Troitskaya A. (2022) Pravovyye otvety na voprosy o redaktirovanii genoma cheloveka (s uchyotom tekhnologii CRISPR-Cas9) [Legal answers to questions about editing the human genome (considering CRISPR-Cas9 technology)]. Sravnitel’noe konstitutsionnoe obozrenie, vol. 31, no. 5, pp. 11–41. (In Russian).
Andorno R. (2015) The Oviedo Convention: A European Legal Framework at the Intersection of Human Rights and Health Law. Journal of International Biotechnology Law, vol. 4, no. 2, pp. 133–143.
Baltimore D. et al. (2015) A Prudent Path Forward for Genomic Engineering and Germline Gene Modification. Science, vol. 348, no. 6230, pp. 36–38.
Barnett S.A. (2017) Regulating Human Germline Modification in Light of CRISPR. University of Richmond Law Review, vol. 51, pp. 553–591.
Baumann M. (2016) CRISPR/Cas9 Genome Editing – New and Old Ethical Issues Arising from Revolutionary Technology. NanoEthics, vol. 10, no. 2, pp. 139–159.
Belova D.A. (2019) Pravovaya priroda embriona in vitro [Legal nature of the embryo in vitro]. Lex russica, no. 6, pp. 122–130. (In Russian).
Brokowski C., Adli M. (2019) CRISPR Ethics: Moral Considerations for Application of a Powerful Tool. Journal of Molecular Biology, vol. 431, no. 1, pp. 88–101.
Cavaliere G. (2018) Genome Editing and Assisted Reproduction: Curing Embryos, Society or Prospective Parents? Medicine, Health Care and Philosophy, vol. 21, no. 2, pp. 215–225.
Darnovsky M., Hasson K. (2020) CRISPR’s Twisted Tales: Clarifying Misconceptions about Heritable Genome Editing. Perspectives in Biology and Medicine, vol. 63, no. 1, pp. 155–176.
De Melo-Martin I. (2016) Rethinking Reprogenetics: Enhancing Ethical Analyses of Reprogenetic Technologies, Oxford: Oxford University Press.
Gnatik E.N. (2016) Genetika cheloveka: byloe i gryadushchee [Human genetics: past and future], Moscow: Lenand. (In Russian).
Guttinger S. (2018) Trust in Science: CRISPR-Cas9 and the Ban on Human Germline Editing. Science and Engineering Ethics, vol. 24, no. 4, pp. 1077–1096.
Gyngell Ch., Douglas Th., Savulescu J. (2017) The Ethics of Germline Gene Editing. Journal of Applied Philosophy, vol. 34, no. 4, pp. 498–513.
Habermas J. (2003) The Future of Human Nature, Cambridge: Polity Press.
Henaghan M. (2006) Choosing Genes for Future Children: Regulating Preimplantation Genetic Diagnosis, Dunedin, N.Z.: Human Genome Research Project.
Hinde R.A. (2002) Why Good Is Good: The Sources of Morality, London; New York: Routledge.
Ihry R.J., Worringer K.A., Salick M.R. et al. (2018) p53 Inhibits CRISPR–Cas9 Engineering in Human Pluripotent Stem Cells. Nature Medicine, no. 24, pp. 939–946.
Khramova T., Troitskaya A. (2021) Nekotorye voprosy ne imeyut otvetov, ili Delo o preryvanii beremennosti [Questions without answers, or Тhe Abortion сase]. Mezhdunarodnoe pravosudie, vol. 11, no. 1, pp. 13–42. (In Russian).
Knoepfler P. (2016) GMO Sapiens: The Life-Changing Science of Designer Babies, Singapore: World Scientific.
Lander E.S. (2015) Brave New Genome. New England Journal of Medicine, vol. 373, no. 1, pp. 5–8.
Lapaeva V.V. (2021) Eticheskiy komitet kak element sistemy upravleniya v nauchno-ekhnologicheskoy sfere: problemy i perspektivy [Ethics committee as an element of the governance system in the scientific and technological sphere: problems and perspectives]. Upravlenie naukoy: teoriya i praktika, no. 4, pp. 112–122. (In Russian).
Lavazza A. (2019) Parental Selective Reproduction: Genome-Editing and Maternal Behavior as a Potential Concern. Frontiers in Genetics, vol. 10, no. 6, pp. 1–5.
Ledford H. (2015) CRISPR, The Disruptor. Nature, vol. 522, pp. 20–24.
Liang P., Xu Y., Zhang X. et al. (2015) CRISPR/Cas9-Mediated Gene Editing in Human Tripronuclear Zygotes. Protein Cell, vol. 5, no. 6, pp. 363–372.
Logunov D.Y., Dolzhikova I.V., Zubkova O.V. et al. (2020) Safety and Immunogenicity of an rAd26 and rAd5 Vector-Based Heterologous Prime-Boost COVID-19 Vaccine in Two Formulations: Two Open, Non-Randomised Phase 1/2 Studies from Russia. The Lancet, vol. 396, pp. 887–897.
Logunov D.Y., Dolzhikova I.V., Shcheblyakov D.V. et al. (2021) Safety and Efficacy of an rAd26 and rAd5 Vector-Based Heterologous Prime-Boost COVID-19 Vaccine: An Interim Analysis of a Randomised Controlled Phase 3 Trial in Russia. The Lancet, vol. 397, pp. 671–681.
Lundberg A.S., Novak R. (2015) CRISPR-Cas Gene Editing to Cure Serious Diseases: Treat the Patient, Not the Germ Line. American Journal of Bioethics, vol. 15, no. 12, pp. 38–40.
Mokhov A.A. (2022) Biopravo i strategiya ego razvitiya v Rossiyskoy Federatsii [Biolaw and its development strategy in the Russian Federation]. Aktual’nye problemy rossiyskogo prava, no. 2, pp. 201–210. (In Russian).
Morrison M., de Saille S. (2019) CRISPR in Context: Towards a Socially Responsible Debate on Embryo Editing. Palgrave Communications, vol. 5, no. 1, pp. 1–9.
Mulvihill J.J., Capps B., Joly Y., Lysaght T., Zwart H.A.E., Chadwick R. (2017) Ethical Issues of CRISPR Technology and Gene Editing through the Lens of Solidarity. British Medical Bulletin, vol. 122, no. 1, pp. 17–29.
Nurk S., Koren S., Rhie A. et al. (2022) The Complete Sequence of a Human Genome. Science, vol. 376, no. 6588, pp. 44–53.
Passarge E. (2021) Naglyadnaya genetika [Color atlas of genetics], N.S.Tikhomirova (transl.), D.V.Rebrikov (ed.), Moscow: Laboratoriya znaniy. (In Russian).
Pekshev A.V. (2021) Problemy eticheskogo vospriyatiya obshchestvom i gosudarstvom meditsinskikh geneticheskikh tekhnologiy [Problems of ethical perception by society and the state of medical genetic technologies]. In: Mokhov A.A., Sushkova O.V. (eds.) Geneticheskie tekhnologii i meditsina: doktrina, zakonodatel’stvo, praktika: monografiya [Genetic technologies and medicine: doctrine, legislation, practice: a monograph], Moscow: Prospekt, pp. 161–164. (In Russian).
Polcz S., Lewis A. (2016) CRISPR-Cas9 and Non-Germline Non-Controversy. Journal of Law and the Biosciences, vol. 3, no. 2, pp. 413–425.
Revazyan K.Z., Meshkov A.N., Ershova A.I., Sivakova O.V., Glechyan A.M., Drapkina O.M. (2020) Geneticheskiy skrining na geterozigotnoe nositel’stvo mutatsiy, vyzyvayushchikh razvitie monogennykh retsessivnykh zabolevaniy [Genetic screening for heterozygous carriage of mutations that cause the development of monogenic recessive diseases]. Profilakticheskaya meditsina, no. 6, pp. 111–117. (In Russian).
Saxton M. (2013) Disability Rights and Selective Abortion. In: Davis L.J. (ed.) The Disability Studies Reader, London; New York: Routledge, pp. 87–99.
Schandera J., Mackey T. (2016) Mitochondrial Replacement Techniques: Divergence in Global Policy. Trends in Genetics, vol. 32, no. 7, pp. 385–390.
Sýkora P. (2019) Germline Genome Editing and Human Nature. In: Sýkora P. (ed.) Promises and Perils of Emerging Technologies for Human Condition: Voices from Four Postcommunist Central and East European Countries, Berlin: Peter Lang Publishing, pp. 141–161, 142.
Sýkora P. (2018) Germline Gene Therapy in the Era of Precise Genome Editing: How Far Should We Go? In: Soniewicka M. (ed.) The Ethics of Reproductive Genetics. Between Utility, Principles, and Virtues, Cham: Springer, pp. 157–171.
Sykora P., Caplan A. (2017) The Council of Europe Should Not Reaffirm the Ban on Germline Genome Editing in Humans. EMBO Reports, vol. 18, no. 11, pp. 1871–1872.
Thieffry D., Sarkar S. (1998) Forty Years under the Central Dogma. Trends of Biochemical Sciences, vol. 23, no. 8, pp. 312–316.
Travis J. (2015) Making the Cut. Science, vol. 350, no. 6267, pp. 1456–1457.
Vlasov V.V., Medvedev S.P., Zakiyan S.M. (2014) “Redaktory genomov”. Ot “tsinkovykh pal’tsev” do CRISPR [“Genome editors”. From “zinc-fingers” to CRISPR]. Nauka iz pervykh ruk, no. 2, pp. 44–53. (In Russian).
Wolbring G., Diep L. (2016) The Discussions Around Precision Genetic Engineering: Role of and Impact on Disabled People. Laws, vol. 5, no. 3, pp. 37–60.
Xue Ch., Seetharam A.S., Musharova O., Severinov K., Brouns S.J.J., Severin A.J., Sashital D.J. (2015) CRISPR Interference and Priming Varies with Individual Spacer Sequences. Nucleic Acids Research, vol. 43, no. 22, pp. 10831–10847.