Legal regulation of gene editing procedure: USA and EU experience
- Authors: Trikoz E.N.1,2, Mustafina-Bredikhina D.M.2, Gulyaeva E.E.3
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Affiliations:
- MGIMO University
- Peoples' Friendship University of Russia (RUDN University)
- Diplomatic Academy of the Ministry of Foreign Affairs of the Russian Federation
- Issue: Vol 25, No 1 (2021): BIOMEDICINE AND LAW
- Pages: 67-86
- Section: GENETICS AND LAW
- URL: https://journals.rudn.ru/law/article/view/26036
- DOI: https://doi.org/10.22363/2313-2337-2021-25-1-67-86
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Abstract
The problem of legal regulation of gene editing in recent years has obviously become global in nature due to the lack of unified systematic legislation in the world. The authors set a goal to study the main existing regulatory legal acts and determine whether there is currently an array of legislation that protects and at the same time establishes responsibility for the «editors» of the genome and persons who have given consent to it, before future generations, who will receive the edited gene, but who did not actually ask for it. The authors analyzed the most known general public cases related to patent disputes for the CRISPR-Cas9 genome editing technology and came to the conclusion that the strong desire to obtain the legal status of the author of the CRISPR/Cas9 genome modification technology is explained not by scientific ambitions but by commercial interest in a promising technology.
About the authors
Elena N. Trikoz
MGIMO University; Peoples' Friendship University of Russia (RUDN University)
Author for correspondence.
Email: alena_trikoz@mail.ru
Candidate of Legal Sciences, Associate Professor, History of Law and State Department, Law Institute, Peoples' Friendship University of Russia (RUDN University); Department of Theory of Law and Comparative Law, International Law Department, MGIMO University
76 Vernadsky Prospekt, Moscow, 119454, Russian Federation; 6 Miklukho-Maklaya str., Moscow, 117198, Russian FederationDiana M. Mustafina-Bredikhina
Peoples' Friendship University of Russia (RUDN University)
Email: diana-mus@yandex.ru
Candidate of Legal Sciences, Department of Administrative and Financial Law, Law Institute
6 Miklukho-Maklaya str., Moscow, 117198, Russian FederationElena E. Gulyaeva
Diplomatic Academy of the Ministry of Foreign Affairs of the Russian Federation
Email: gulya-eva@yandex.ru
Candidate of Legal Sciences, Associate Professor, European Law Department
53/2-1 Ostozhenka str., Moscow, 119021, Russian FederationReferences
- Abdullin, A.I. (2008) Legal protection of biotechnological inventions: European experience. The Review of Economy, the Law and Sociology. (6), 66-78. (in Russian).
- Valdes, E. & Lecaros, J.A. (eds.) (2019) Biolaw and Policy in the Twenty-First Century. Building Answers for New Questions. Springer Nature Switzerland, Springer International Publ.
- Brandt-Rauf, P.W. & Brandt-Rauf, S.I. (2004) Genetic testing in the workplace: ethical, legal, and social implications. Annual Review Public Health. 25, 139-153. doi: 10.1146/annurev.publhealth.25.101802.123012
- Cohen, J. (2017) How the battle lines over CRISPR were drawn. Scientific Community. doi: 10.1126/science.aal0763
- Cyranoski, D. (2019) The CRISPR-baby scandal: what’s next for human gene-editing. Nature. 566, 440-442. Doi: https://doi.org/10.1038/d41586-019-00673-1
- Denisenko, V. & Trikoz, E. (2020) Biopolitics and legal issues of emergency situations in the context of coronavirus pandemic. In: XIII International Scientific and Practical Conference “State and Prospects for the Development of Agribusiness - INTERAGROMASH 2020”. E3S Web of Conferences. 175(14013), pp. 1-7. Doi: https://doi.org/10.1051/e3sconf/202017514013
- Faunce, T.A. (2005) Will international human rights subsume medical ethics? Intersections in the UNESCO Universal Bioethics Declaration. Journal of Medical Ethics. 31(3), 173-178.doi: 10.1136/jme.2004.006502
- Fomina, O.Yu. (2019) Availability of Judicial Protection in the Process of Editing the Human Genome. Lex Russica. (6), 37-47. Available from: https://doi.org/10.17803/1729-5920.2019. 151.6.037-047. (in Russian).
- Fukuyama, F. (2002) Our Posthuman Future: Consequences of the Biotechnology Revolution. New York, Farrar, Strauss and Giroux.
- Gaj, Th., Gersbach, Ch.A. & Barbas, C.F. (2013) ZFN, TALEN and CRISPR/Cas-based methods for genome engineering. Trends in Biotechnology. 31(7), 397-405, doi: 10.1016/j.tibtech. 2013.04.004
- Gasiunas, G., Barrangou, R., Horvath, Ph. & Siksnys, V. (2012) Cas9-crRNA ribonucleoprotein complex mediates specific DNA cleavage for adaptive immunity in bacteria. Proceedings of the National Academy of Sciences. 109(39), E2579-E2586. Doi.org/10.1073/pnas.1208507109
- Ishii, T. (2017) Germ line genome editing in clinics: the approaches, objective and global society. Brief Funct Genomics. 16(1), 46-56.
- Jinek, M., Chylinski, K., Fonfara, I., Hauer, M., Doudna, J.A. & Charpentier, E. (2012) A Programmable Dual-RNA - Guided DNA Endonuclease in Adaptive Bacterial Immunity. Science. 337(6096), 816-821. doi: 10.1126/science.1225829
- Kalinichenko, P.A. (2019) Development of Court Practice in Cases Involving Human Genomics: World Experience and Russia. Lex Russica. 6(151), 30-36. (in Russian).
- Kipling, J. (2016) The European Landscape for Human Genome Editing. A review of the current state of the regulations and ongoing debates in the EU. Federation of European Academies of Medicine (FEAM). Available from: https://acmedsci.ac.uk/file-download/41517573f212e2b52a.pdf [Accessed 18th November 2020].
- Krekora-Zając, D. (2020) Civil liability for damages related to germline and embryo editing against the legal admissibility of gene editing. Palgrave Communications. (6), 30. Doi.org/10.1057/s41599-020-0399-2
- Kurakov, F.A. (2017) Patent Disputes about the Rights to the Technology for Genome Editing as a New Model of Scientific Communication. Manager of Health Care. (7), 50-60. (in Russian).
- Lipkin, S.M. & Luoma, J. (2018) The Age of Genomes Tales from the Front Lines of Genetic Medicine. Translation from English. Moscow, Alpina non-fiction Publ. (in Russian).
- Montgomery, J. (2018) Modification of the Human Genome: Challenges from the Human Rights Sphere Caused by Scientific and Technological Advances. Precedents of the European Court of Human Rights. (3), 42-56. (in Russian).
- Roger, A. & De Bousingen, D.D. (1995) Bioethics in Europe. Brussels, Council of Europe Press.
- Sontheimer, E.J. & Barrangou, R. (2015) The Bacterial Origins of the CRISPR Genome-Editing Revolution. Human Gene Therapy. 26(7), 413-424. doi: 10.1089/hum.2015.091
- Tkachuk, V.V. (2019) Consequences of the EU Court Judgment in the «Oliver Brüstle V Greenpeace eV» Case for Genomic Researches within the European Union. Courier of Kutafin Moscow State Law University (MSAL). 4 (56), 138-145. (in Russian).
- Trikoz, E.N. & Gulyaeva, E.E. (2018) Positions of the ECHR on some issues of bioethics and genetic data. Advances in Law Studies. 6(4), 36-40. (in Russian).
- Tuerlings, E. (2019) WHO Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing. Background Paper Governance. Human Genome Editing. Available from: https://www.who.int/ethics/topics/human-genomeediting/WHO-Commissioned-Governance-1-paper-March-19.pdf [Accessed 15th November 2020].
- Van Dijke, I., Bosch, L., Bredenoord, A.L., Cornel, M., Repping, S. & Hendriks, S. (2018) The ethics of clinical applications of germline genome modification: a systematic review of reasons. Human Reproduction. 9(33), 1777-1796.
- Yesley, M.S. (2005) What’s ELSI got to do with it? Bioethics and the human genome project. New Genetics and Society. (27), 1-6.
- Yudin, B.G. (2016) Editing of a Human being. Human Being. (3), 5-19. (in Russian).