Legal Status of Biobanks

The author sets out to examine the legal status of biobanks in Russian and foreign legal systems. The legal regulation of biobanking is shown to remain insufficient. The author analyzes existing approaches to the nature of biobanks and concludes that a biobank should be regarded a legal entity with special legal capacity. It is proposed to define a biobank as an organization (or its structural subdivision) that carries out all or some activities of the following activities: collection, processing, acquisition, storage, transfer, and research of human biological materials, as well as biomaterials obtained from animals, plants, and other organisms, along with the related information for medical, scientific, educational, and other purposes. The identified gaps in the legal regulation of biobanks can be addressed through the adoption of either a law on biobanks or a comprehensive law on genetic technologies.

1. Agarkov, M.M. (1946). The concept of a transaction under Soviet civil law. Soviet state and law, (3–4), 41–55. (In Russ.).

2. Alexeev, S.S., (1982). General theory of law. (Vol. 2). Moscow: Yuridicheskaya literatura Publ. (In Russ.).

3. Artene, S.A., Ciurea, M.E., Purcaru, S.O., Tache, D.E., Tataranu, L.G., Lupu, M., Dricu, A. (2013). Biobanking in a constantly developing medical world. The Scientific World Journal, (1), 343275. https://doi.org/10.1155/2013/343275

4. Asslaber, M., Zatloukal, K. (2007). Biobanks: transnational, European and global networks. Briefings in functional genomics and proteomics, 6(3), 193–201. https://doi.org/10.1093/bfgp/elm023

5. Balashova, A.I. (2023). Peculiarities of the legal regime of databases classified as biobanks. Intellectual Property. Copyright and Related Rights, (3), 18–33. (In Russ.).

6. Boltanova, E.S., Imekova, M.P. (2021). The Types of Biological Databases (Biobanks). Bulletin of Tomsk State University. Journal of Law, (41), 136–148. (In Russ.).

7. Bragina, Yu., Buikin, S.V., Puzyrev, V.P. (2009). Biological Banks: Problems and Prospects of Their Use in Investigations of Genetic Aspects of Human Complex Diseases of Human. Medical Genetics, 8(3), 20–26. (In Russ.).

8. Buikin S.V., Bragina Ye.Yu., Koneva L.A., Puzyryov V.P. (2012). Databases of biological collection: organization of associated information. Bulletin of Siberian Medicine, 11(1), 111–121. (In Russ.). https://doi.org/10.20538/1682-0363-2012-1-111-121

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

10. Cheng, L.E., Shi, C., Wang, X., Li, Q., Wan, Q., Yan, Z., Zhang, Y. (2013). Chinese biobanks: present and future. Genetics Research, 95(6), 157–164. https://doi.org/10.1017/S0016672313000190

11. Cherdantsev, A.F. (1964). The concept of technical and legal norms and their role in the formation of social relations. Soviet State and Law, (7), 134–138. (In Russ.).

12. Egorov, Yu.P. (2004). Will and Its Expression in Transactions. Zakonodatelstvo, (10), 53–58. (In Russ.).

13. Eropkin, M.Yu. (2015). Biobanks and their role in the systems of biosafety, healthcare, biotechnology, ecology and the “knowledge economy”. Available at: https://old.influenza.spb.ru/files/publications/rii-epub-biobanks-2015.pdf. (In Russ.).

14. Eugenzikht, V.A. (1983). Will and Expression of Will (Essays on the Theory, Philosophy, and Psychology of Law). Dushanbe: Donish. (In Russ.).

15. Harati, M.D., Williams, R.R., Movassaghi, M., Hojat, A., Lucey, G.M., Yong, W.H. (2019). An Introduction to Starting a Biobank. In: Yong, W. (ed.). Biobanking. Methods in Molecular Biology. (Vol. 1897, pp. 7–16). New York, NY: Humana Press. https://doi.org/10.1007/978-1-4939-8935-5_2

16. Henderson, G.E., Cadigan, R.J., Edwards, T.P., Conlon, I., Nelson, A.G., Evans, J.P., Davis, A.M., Zimer C., Weiner, B.J. (2013). Characterizing biobank organizations in the US: results from a national survey. Genome medicine, 5(1), 12. https://doi.org/10.1186/gm407

17. Imekova, M.P. (2020). Biobank as an object of rights. Journal of Russian law, (12), 54–65. (In Russ.). https://doi.org/10.12737/jrl.2020.147

18. Ivannikov, V.A. (2006). Psychological mechanisms of volitional regulation. Moscow: Piter Publ. (In Russ.).

19. Kashanin, A.V. (2001). Causa of a Civil Law Contract as an Expression of Its Essence. Journal of Russian Law, (4), 93–104. (In Russ.).

20. Kauffmann, F., Cambon-Thomsen, A. (2008). Tracing biological collections: between books and clinical trials. Jama, 299(19), 2316–2318. https://doi.org/10.1001/jama.299.19.2316

21. Kryukova, E.S., Ruzanova, V.D. (2021). Legal regime of biobanks in domestic legislation. Juridical Journal of Samara University, 7(1), 57–62. (In Russ.). https://doi.org/10.18287/2542-047X-2021-7-1-57-62

22. Kurmashev, N.V. (2007). The Doctrine of Will in Legal Transactions in Soviet and Modern Russian Civil Law Science. Civil Law Review, (1), 67–83. (In Russ.).

23. Maleina, M.N. (2020). Legal status of a biobank (a bank of human biological materials). Law. Journal of the Higher School of Economics, (1), 98–117. (In Russ.). https://doi.org/10.17323/2072-8166.2020.1.98.117

24. Maleina, M.N. (2021). Agreement for Cryopreservation and Storage of Human Biological Material in a Personal Biobank. Journal of Russian Law, 25(4), 71–82. (In Russ.). https://doi.org/10.12737/jrl.2021.046

25. Matuzov, N.I. (1996). Law in the system of social norms. Proceedings of Higher Educational Institutions. Pravovedenie, (2), 144–157. (In Russ.).

26. Mokhov, A.A. (2018). Biobanking – a New Direction of Economic Activity. Courier of Kutafin Moscow State Law University (MSAL), (3), 33–40. (In Russ.). https://doi.org/10.17803/2311-5998.2018.43.3.033-040

27. Novitsky, I.B. (1954). Transactions. Statute of Limitations. Moscow: Gosyurizdat Publ. (In Russ.).

28. Osmanova, D.O. (2024). Competitivity Issues Related to Biobank Activity. Lex Genetica, 3(1), 7–32. (In Russ.). https://doi.org/10.17803/lexgen-2024-3-1-7-32

29. Ostanina, E.A. (2023). Biobank as a legal category. Juridical Journal of Samara University, 9(2), 65–70. (In Russ.). http://doi.org/10.18287/2542- 047X-2023-9-2-65-70

30. Panov, A. A. (2011). On the categories of will, expression of will, and vice of will in the theory of legal transactions. Civil Law Review, (1), 52–81. (In Russ.).

31. Reznik, O.N., Kuzmin, D.O., Skvortsov, A.E., Reznik, A.O. (2016). Biobanks as an Essential Tool for Transplantation. History, Current State, Perspectives. Russian Journal of Transplantology and Artificial Organs, 18(4), 123–132. (In Russ.). https://doi.org/10.15825/1995-1191-2016-4-123-132

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

33. Sarmanaev, S.Kh., Shirokov, A.Yu., Vasiliev, S.A., Osavelyuk, A.M., Zenin, S.S., Suvorov, G.N. (2019). Proposals for Extending the Russian Biobanks Functions to Protect Genomic Information. Lex Russica, (6), 153–160. (In Russ.) https://doi.org/10.17803/1729-5920.2019.151.6.153-160

34. Shershenevich, G.F. (1911). Textbook of Russian civil law. Moscow: Tipografija Tovarishhestva I.N. Kushnerev i K°793. (In Russ.).

35. Sterckx, S., Van Assche, K. (2011). The new Belgian law on biobanks: some comments from an ethical perspective. Health Care Analysis, 19(3), 247–258. https://doi.org/10.1007/s10728-011-0181-0

36. Vasilyev, G.S. (2018). Human biomaterial as an object of law. Pravovedenie, 62(2), 308–361. (In Russ.). https://doi.org/10.21638/11701/spbu25.2018.205

37. Vengerov, A.B. (2005). Theory of State and Law. (2nd ed.). Moscow: Omega-L Publ. (In Russ.)

38. Zika, E., Paci, D., Schulte, I.D., Braun, A., Rijkers-Defrasne, S., Deschênes, M., Fortier I., Laage-Hellman J., Scerri C.A., Ibarreta, D. (2010). Biobanks in Europe: prospects for harmonisation and networking. Luxembourg: Publications Office of the European Union, 175.