The legal regulation of genomic DNA banks in the context of social, cultural and regulatory diversity
https://doi.org/10.17803/1994-1471.2019.100.3.030-038
Abstract
The article deals with the normative regulation of genetic research and bioengineering, compares the experience of different countries in this area. The author subjects a legislative framework for the preservation of privacy in the formation of biobanks in such countries as Denmark, Israel and China to a detailed analysis. On the example of law enforcement practice in the States mentioned above, the author shows the variety of ways of development of relevant legislation, as well as the impact of legal, political and socio-cultural traditions on those ways. Special attention is paid to the connection of genetic research with the development of computer technologies that require complex legal regulation with due regard to specifics of genomic and computer knowledge. The author substantiates relevance of the thesis about a decisive role of the influence of political and administrative reasons in choosing the strategy of legislative and institutional regulation of biotechnology and bioengineering by means of a comparative review of various schemes and models emerging in Danish, Israeli and Chinese legal reality. In the article, the authors shift from the problem of development of legal support of genomic biobanks to the problem of ethical foundations of this activity, and expand the angle of view by considering protection of rights of unborn children, protection of rights of minors and those who have lost their legal capacity due to old age. The authors systematize and problematize the issues of preserving effectiveness of legal regulation in the development of precision (personalized) medicine that is based on the ontology of the unique, while law enforcement, in principle, is normative, and, therefore, based on the ontology of the universal.
About the Authors
V. I. Przhilenskiy
Kutafin Moscow State Law University (MSAL)
Russian Federation
Russian Federation
Doctor of Philosophy, Professor, Professor of the Department of Philosophy and Sociology,
125993, Moscow, ul. Sadovaya-Kudrinskaya, d. 9
A. A. Vergun
Moscow Pedagogical State University
Russian Federation
Russian Federation
PhD, Associate Professor, Deputy Head of the Department of Biochemistry, Molecular Biology and Genetics, Institute of Biology and Chemistry, Researcher of the Laboratory of Genome Organization IBG RAS,
125993, Moscow, ul. Sadovaya-Kudrinskaya, d. 9
References
1. Przhilenskiy V. I. Yuridicheskoe poznanie i pravoprimenitel’nye praktiki v kontekste neklassicheskoy epistemologii // Voprosy filosofii. — 2015. — № 8. — S. 42—53.
2. Troshchinskiy P. V. Pravovaya sistema Kitayskoy Narodnoy Respubliki: stanovlenie, razvitie i kharakternye osobennosti // Vestnik Universiteta imeni O.E. Kutafina (MGYuA). — 2015. — № 5. — S. 99—117.
3. Fukuyama F. Nashe postchelovecheskoe budushchee: Posledstviya biotekhnologicheskoy revolyutsii. — M. : AST, Lyuks, 2004. — 349 s.
4. Chen H., Chan B., Joly Y. Privacy and Biobanking in China: A Case of Policy in Transition // J Law Med Ethics. — 2015 Winter. — 43(4):726—42.
5. Chen Y., Song L. China: concurring regulation of cross-border genomic data sharing for statist control and individual protection // Hum Genet. — 2018 Aug. — 137(8):605—615.
6. Evans B. J. Impact of HIPAA’s minimum necessary standard on genomic data sharing // Genet Med. 2018 Apr. — 20(5):531—535.
7. Hartlev M. Genomic Databases and Biobanks in Denmark // J Law Med Ethics. — 2015 Winter. — 43(4):743— 53.
8. Hewitt J. E. The Ethical, Legal and Regulatory Issues Associated with Pharmacogenomics: Systematically Quantifying the Literature // J Law Med. 2018 Apr. — 25(3):782—793.
9. Eichenwald K. Redesigning Nature: Hard Lessons Learned; Biotechnology Food: From a Lab to a Debacle // The New York Times. — January 25, 2001. — P. Al.
10. Rothstein M. A. Genetic Exceptionalism and Legislative Pragmatism // Hastings Center Report 35. — no. 4 (2005): 27—33.
11. Olson M. V. Precision medicine at the crossroads // Hum Genomics. — 2017 Oct 11. —11(1):23.
12. Siegal G. Genomic Databases and Biobanks in Israel // J Law Med Ethics. — 2015 Winter. — 43(4):766—75.
13. Toward Precision Medicine: Building a Knowledge Network for Biomedical Research and a New Taxonomy of Disease. Editors National Research Council (US) Committee on A Framework for Developing a New Taxonomy of Disease. Source Washington (DC): National Academies Press (US); 2011 // URL: https://www.ncbi.nlm. nih.gov/books/NBK91503/ (дата обращения: 13 декабря 2018 г.).
14. Voronin M. V., Zakharova M. V. Medida de libertad en el contexto de la regulación legal de la investigación genómica: experiencia extranjera // Revista Dilemas Contemporáneos: Educación, Política y Valores. ño: VI Número: Edición Especial Artículo no.:16 Período: Diciembre 2018.
Review
For citations:
Przhilenskiy V.I., Vergun A.A. The legal regulation of genomic DNA banks in the context of social, cultural and regulatory diversity. Actual Problems of Russian Law. 2019;(3):30-38. (In Russ.) https://doi.org/10.17803/1994-1471.2019.100.3.030-038
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