Genomic Research in Reproduction and Biobanking: An Analysis of International Legal Approaches

Sergey Vyacheslavovich  Kosilkin; Aleksey Viktorovich  Kubyshkin; Elizaveta Kirillovna  Moskovkina; Maria Vladimirovna  Nekoteneva; Vladislav Olegovich  Tyumentsev

doi:10.6000/1929-4409.2020.09.338

Authors

Sergey Vyacheslavovich Kosilkin Ph.D. in Law, Head of Practice of the Law Firm "Advanced Legal Consulting", Moscow, Russia; Expert of the Scientific Collaboration "Legal Genomics Developments Alliance (LeGenDA)", Russia
Aleksey Viktorovich Kubyshkin Ph.D. in Law, Advocate at Advocate’s Office “SanctaLex” of the Moscow City Bar Association, Moscow, Russia; partner of the Scientific Collaboration "Legal Genomics Developments Alliance (LeGenDA)", Russia
Elizaveta Kirillovna Moskovkina PJSC «Oil Company «Rosneft», Moscow, Russia; Expert of the Scientific Collaboration "Legal Genomics Developments Alliance (LeGenDA)", Russia
Maria Vladimirovna Nekoteneva Ph.D. in Law, Associate Professor of the Department of Integration and European Law at the University named after O.E. Kutafina (Moscow State Law Academy), Moscow, Russia; Expert of the Scientific Collaboration "Legal Genomics Developments Alliance (LeGenDA)", Russia
Vladislav Olegovich Tyumentsev Postgraduate Student of the Department of Integration and European Law of the University named after O.E. Kutafina (Moscow State Law Academy), Moscow, Russia; Expert of the Scientific Collaboration "Legal Genomics Developments Alliance (LeGenDA)", Russia

DOI:

https://doi.org/10.6000/1929-4409.2020.09.338

Keywords:

Genomic research, DNA, biobanking, commercial use of results, human rights.

Abstract

The article examines the regulatory issues of genomic research in human reproduction and biobanking. The approaches to legal regulation at the level of international law, integration organizations, and individual states are analyzed. Based on the analysis, proposals for legal regulation are formulated. Regarding the legal regulation of genomic research in the field of biobanking, the article discusses the issue of the legal standing of biobanks, approaches to the legal regulation of biobanks in various countries, and formulates proposals for the commercial use of the results of genomic research in biobanking. The article also provides an overview of some judicial decisions that had a certain impact on forming legal regulation of genomic research in the field of biobanking and human reproduction.

References

Brown, D. L. (2018). Can the ‘Immortal Cells’ of Henrietta Lacks Sue for Their Own Rights? https://www.washingtonpost.com/ news/retropolis/wp/2018/06/25/can-the-immortal-cells-of-henrietta-lacks-sue-for-their-own-rights/

Chen, H., Chan, B., & Joly, Y. (2015). Privacy and biobanking in China: A case of policy in transition. The Journal of Law Medicine & Ethics, 43(4), 726-742. https://doi.org/10.1111/jlme.12315 DOI: https://doi.org/10.1111/jlme.12315

Council of Europe. (1997). Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. https://rm.coe.int/168007cf98 DOI: https://doi.org/10.1353/ken.1997.0021

Council of Europe. (1998). 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. https://rm.coe.int/168007f2ca

Council of Europe. (2016). Recommendation CM/Rec(2016)6 of the Committee of Ministers to Member States on Research on Biological Materials of Human Origin. https://search.coe.int/ cm/Pages/result_details.aspx?ObjectID=090000168064e8ff

Council of Europe. (2020). Chart of Signatures and Ratifications of Treaty 164. https://www.coe.int/en/web/conventions/full-list/-/conventions/treaty/164/signatures?p_auth=F4uxBQvK

De Vries, R. G., & Tomlinson, T. (2016). Americans Want a Say in What Happens to Their Donated Blood and Tissue in Biobanks. https://theconversation.com/americans-want-a-say-in-what-happens-to-their-donated-blood-and-tissue-in-biobanks-60681

European Court of Human Rights. (2015). ECHR 2015/20 Case of Parillo v. Italy, 27 August 2015, no. 46470/11 (Grand Chamber).

European Court Reports. (2011). Case C-34/10, Oliver Brüstle v Greenpeace eV. http://curia.europa.eu/juris/liste.jsf? language=en&num=C-34/10

European Free Trade Association. (2020). Protocol 31 to the EEA Agreement on Cooperation in Specific Fields outside the Four Freedoms. https://www.efta.int/media/documents/legal-texts/eea/the-eea-agreement/Protocols%20to%20the%20 Agreement/protocol31.pdf

Fogarty, N. M. E., McCarthy, A., Snijders, K. E., Powell, B. E., Kubikova, N., Blakeley, P., Lea, R., Elder, K., Wamaitha, S. E., Kim, D., Maciulyte, V., Kleinjung, J., Kim, J. S., Wells, D., Vallier, L., Bertero, A., Turner, J. M. A., & Niakan, K. K. (2017). Genome editing reveals a role for OCT4 in human embryogenesis. Nature, 550(7674), 67–73. https://doi.org/10.1038/nature24033 DOI: https://doi.org/10.1038/nature24033

Goldberg, R., & Lonbay, J. (2000). Pharmaceutical Medicine, Biotechnologies and European Law. Cambridge: Cambridge University Press. https://doi.org/10.1017/CBO9780511560125 DOI: https://doi.org/10.1017/CBO9780511560125

Kalinichenko, P. A., & Nekoteneva, M. V. (2020). Specifics of legal regulation in genomic researches at the international and european level. Courier of Kutafin Moscow State Law University (MSAL)), 4, 68-78. https://doi.org/10.17803/2311-5998.2020.68.4.068-078 DOI: https://doi.org/10.17803/2311-5998.2020.68.4.068-078

Kalinichenko, P. A., & Ponomareva, D. V. (2019). Ethical and legal aspects of regulating genomic research in international and Russian practice. Medical Radiology and Radiation Safety, 64(5), 69–70. https://doi.org/10.12737/1024-6177-2019-64-5-69-70 DOI: https://doi.org/10.12737/1024-6177-2019-64-5-69-70

Kelland, K. (2018). UK Ethics Body Says Gene-Edited Babies May Be 'Morally Permissible'. https://www.reuters.com/article/us-health-genome-ethics-idUSKBN1K62VI/

Kodyleva, T. A., Kirillova, A. O., Tyshchik, E. A., Makarov, V. V., Khromov, A. V., Guschin, V. A., Abubakirov, A. N., Rebrikov, D. V., & Sukhikh, G. T. (2018). The efficacy of CRISPR-CAS9-mediated induction of the CCR5DELTA32 mutation in the human embryo. Bulletin of the Russian State Medical University, 4, 80-83. https://doi.org/10.24075/vrgmu.2018.052 DOI: https://doi.org/10.24075/brsmu.2018.052

Kubyshkin, A. V., Kosilkin, S. V., & Astrelina, T. A. (2019). International legal regulation of genetic research, bio-banking, bioinformatics and human reproduction: analysis of the main international legal acts. International Legal Courier, 2(19), 29-34. http://inter-legal.ru/wp-content/uploads/2019/ 10/21-10-web.pdf

Lander, E., Baylis, F., Zhang, F., Charpentier, E., Berg, P., Bourgain, C., Friedrich, B., Joung, J. K., Li, J., Liu, D., Naldini, L., Nie, J.-B., Qiu, R., Schoene-Seifert, B., Shao, F., Terry, S., Wei, W., & Winnacker, E.-L. (2019). Adopt a moratorium on heritable genome editing. Nature, 567, 165-168. https://doi.org/10.1038/d41586-019-00726-5 DOI: https://doi.org/10.1038/d41586-019-00726-5

LexisNexis. (2012). Mayo Collaborative Servs. v. Prometheus Labs., Inc. - 566 U.S. 66, 132 S. Ct. 1289. https://www.lexisnexis. com/community/casebrief/p/casebrief-mayo-collaborative-servs-v-prometheus-labs-inc-834664167

Liang, B. A., & Mackey, T. (2010). Addressing Institutional Conflict of Interest to Promote Patient Safety. https://www.psqh.com/ analysis/addressing-institutional-conflict-of-interest-to-promote-patient-safety/

Melnitzer, J. (2016). Canadian Patent Settlement Sets Model for Not-For-Profit Gene Testing. https://business.financialpost.com/ legal-post/canadian-patent-settlement-sets-model-for-not-for-profit-gene-testing

Ministry of Health. (2006). Directives for Private Healthcare Institutions Providing Assisted Reproduction Services (4.11.2(ii)), 1-10.

Ministry of Health and Social Affairs, Sweden. (2002). Biobanks in Medical Care Act. https://biobanksverige.se/wp-content/uploads/Biobanks-in-medical-care-act-2002-297.pdf

Ministry of Health of the Russian Federation. (2017). Order No. 842n “On Approval of the Requirements for the Organization and Operation of Biobanks and Rules for Storing Biological Material, Cells for the Preparation of Cell Lines, Cell Lines Intended for the Production of Biomedical Cell Products”. http://pravo.gov.ru/

Ministry of Social Affairs and Health, Finland. (2012). Biobank Act. https://finlex.fi/fi/laki/kaannokset/2012/en20120688.pdf

Ministry of Welfare. (2014). The Biobanks and Health Databanks Act. https://www.government.is/media/velferdarraduneyti-media/media/acrobat-enskar_sidur/Biobanks-Act-as-amended-2015.pdf

Montgomery, J. (2018). Modification of the human genome: human rights challenges raised by scientific and technical developments. Precedents of the European Court of Human Rights, 3(51), 42-56.

Moreno, F. A. (2003). Greenberg v. Miami Children’s Hospital RES. INST., INC., 264 F. Supp. 2d 1064 (S.D. Fla. 2003). https://www.courtlistener.com/opinion/2507167/greenberg-v-miami-childrens-hospital-res-inst-inc/

Murtazin, M. F. (2003). Resolutions and Recommendations of the Council of the Islamic Fiqh Academy. Moscow: Ladomir.

Panelli, E. A. (1990). Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990). https://www.courtlistener.com/ opinion/2608931/moore-v-regents-of-university-of-california/?

Presidência da República. (2005). Brazilian Biosafety Law No. 11.105. http://www.planalto.gov.br/ccivil_03/_Ato2004-2006/2005/Lei/L11105.htm#art42

President of Russia. (2016). Law No. 180-FZ “On Biomedical Cell Products”. http://www.kremlin.ru/acts/bank/40894

Pribitkov, K. (2019). WHO Has Formed an Expert Committee to Assess the Consequences of Changes in Human Genes. https://tass.ru/obschestvo/6119748

Rial-Sebbag, E., & Pigeon, A. (2015). Regulation of biobanks in France. Journal of Law, Medicine and Ethics, 43(4), 754-765. https://doi.org/10.1111/jlme.12317 DOI: https://doi.org/10.1111/jlme.12317

Rice, W. (2016). CHEO Reaches ‘Historic’ Settlement with Gene Patent Owner. https://www.cbc.ca/news/canada/ottawa/cheo-gene-patent-lawsuit-settlement-1.3483433

Riigi Teataja. (2001). Human Genes Research Act. https://www.riigiteataja.ee/en/eli/531102013003/

Sarmanaev, S. Kh. Shirokov, A. Yu., Vasiliev, S. A., Osavelyuk, M. A., Zenin, S. S., & Suvorov, G. N. (2019). Proposals for extending the Russian biobanks functions to protect genomic information. Lex Russica, 6(151), 153-160. https://doi.org/10.17803/1729-5920.2019.151.6.153-160 DOI: https://doi.org/10.17803/1729-5920.2019.151.6.153-160

The European Parliament. (2008). Joint Parliamentary Committee 30th Meeting of the EEA Joint Parliamentary Committee. Resolutions and Recommendations. https://www.europarl. europa.eu/cmsdata/146634/20080626ATT32804EN.pdf

The European Parliament and the Council of the European Union. (1998). Directive No. 98/44/EC of the European Parliament and the Council of the European Union “On the Legal Protection of Biotechnological Inventions. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A31998L0044

The European Parliament and the Council of the European Union. (2004). Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on Setting Standards of Quality and Safety for the Donation, Procurement, Testing, Processing, Preservation, Storage and Distribution of Human Tissues and Cells. https://op.europa.eu/de/publication-detail/-/publication/1589d23a-1fd2-40aa-83cb-b8641cb53165/language-en

The Japan Society of Human Genetics, Council Committee of Ethics, Matsuda, I., Niikawa, N., Sato, K., Suzumori, K., Fukushima, Y., Fujiki, N., Kanazawa, I., Nakamura, Y., Yonemoto, S., & Nakagome, Y. (2001). Guidelines for genetic testing. Journal of Human Genetics, 46(3), 163-165. https://doi.org/10.1007/s100380170107 DOI: https://doi.org/10.1007/s100380170107

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, 138-145. https://doi.org/10.17803/2311-5998-2019-56-4-138-145 DOI: https://doi.org/10.17803/2311-5998-2019-56-4-138-145

United Nations. (2005). United Nations Declaration on Human Cloning. https://doi.org/10.1515/jibl.2005.2.5.211 DOI: https://doi.org/10.1515/jibl.2005.2.5.211

United Nations Educational, Scientific and Cultural Organization. (1997). Universal Declaration on the Human Genome and Human Rights. http://portal.unesco.org/en/ev.php-URL_ID= 13177&URL_DO=DO_TOPIC&URL_SECTION=201.html

United Nations Educational, Scientific and Cultural Organization. (2003). International Declaration on Human Genetic Data. http://portal.unesco.org/en/ev.php-URL_ID=17720&URL_DO=DO_TOPIC&URL_SECTION=201.html

Wales, M., & Cartier, E. (2015). The Impact of Myriad on the Future Development and Commercialization of DNA-Based Therapies and Diagnostics. Cold Spring Harbor Perspectives in Medicine, 5(12), a020925. https://doi.org/10.1101/cshperspect.a020925 DOI: https://doi.org/10.1101/cshperspect.a020925

Washington University v. Catalona. (2006). https://caselaw.findlaw. com/us-8th-circuit/1300306.html

Watson, J. D., Berry, A., & Davies, K. (2019). DNA: The Story of the Genetic Revolution. St. Petersburg: Peter.

Wet op bijzondere medische verrichtingen. (1997). https://wetten.overheid.nl/BWBR0008974/2012-01-01

Wilson, R. (2010). The death of Jesse Gelsinger: New evidence of the influence of money and prestige in human research. American Journal of Law & Medicine, 36(2-3), 295-325. https://doi.org/10.1177/009885881003600202 DOI: https://doi.org/10.1177/009885881003600202