DNA as an Object of Legal Regulation

The authors set out to examine challenges associated with defining conceptual frameworks for regulating genomic medicine. The relevance of the study stems from the rapid development of genomic technologies, which alter the existing understanding of human biology. For the first time in human history, science enables forecasting the results of human intervention in human biology through genetic editing. In addition, there appear models for the use of human DNA for technological purposes, e.g., in computers (thus giving rise to a new field of biocomputing) and as memory storage.

Our aim is to identify key gaps in the regulation of genomic technologies; examine the impact of innovations in this area on conventional legal institutions; and outline prospects for improving Russian legislation in this sphere.

The inclination of states to maximize the possibility of genetic sequencing among their populations is shown. This creates opportunities for the development of personalized medicine, enabling the prognosis of human health and the shaping of their health-preserving trajectory. At the same time, previously unexpected risks are emerging, such as the “geneticization” of the law and the state, the vulnerability of human rights, and the use of medical data for achieving social goals. International legal instruments in the field of genomic medicine were adopted in the late 20th and early 21st centuries, when humanity did not yet have complete data on the human genome. Despite discussions regarding the need to adopt a universal convention in this area, practical steps toward achieving this goal have not yet been taken. It is noted that neither international nor national instruments define the concepts of DNA and the human genome. It is emphasized that uncertainty in legal regulation is a significant feature of genomic technologies. We also analyze the legal gaps arising from the use of the human genome for technological purposes. Biocomputing and the use of DNA as a memory storage device are cited to illustrate these issues.

1. Andorno, R. (2005). Dignity of the person in the light of international biomedical law. Medicina e Morale, 54(1), 91–105. https://doi.org/10.4081/mem.2005.412

2. Baylis, F., Darnovsky, M., Hasson, K., Krahn, T.M. (2020). Human germline and heritable genome editing: the global policy landscape. The CRISPR Journal, 3(5), 365–377. https://doi.org/10.1089/crispr.2020.0082

3. Bencurova, E., Akash, A., Dobson, R. C., Dandekar, T. (2023). DNA storage–from natural biology to synthetic biology. Computational and Structural Biotechnology Journal, 21, 1227–1235. https://doi.org/10.1016/j.csbj.2023.01.045

4. Cadigan, R.J., Waltz, M., Conley, J.M., Major, R.M., Branch, E.K., Juengst, E.T., Flatt, M.A. (2024). Human heritable genome editing and its governance: views of scientists and governance professionals. New genetics and society, 43(1), e2404061. https://doi.org/10.1080/14636778.2024.2404061

5. Cadigan, R. J., Waltz, M., Henderson, G. E., Conley, J. M., Davis, A. M., Major, R., Juengst, E. T. (2022). Scientists’ Views on Scientific Self-Governance for Human Genome Editing Research. Human Gene Therapy, 33(21-22), 1157–1163. https://doi.org/10.1089/hum.2022.087

6. Chalova L., Lokshin V. (2020). Mitochondrial Replacement Therapy: Future or Present? Reproductive Medicine (Central Asia). (2(43), 7–12. (In Russ.). https://doi.org/10.37800/RM2020-1-9

7. Cipriani, V., Vestito, L., Magavern, E.F., Jacobsen, J.O., Arno, G., Behr, E.R., ... Smedley, D. (2025). Rare disease gene association discovery in the 100,000 Genomes Project. Nature. https://doi.org/10.1038/s41586-025-08623-w

8. Cohen, J. (2019, October 21). Embattled Russian scientist sharpens plans to create gene-edited babies. Science. Available at: https://www.science.org/content/article/embattled-russian-scientist-sharpens-plans-create-gene-edited-babies

9. Conley, J., Robinson, A., Wilson, R., Kuczynski, K., Henderson, G. (2025). The impact of the three major human genome editing reports on the governance landscape. Journal of Community Genetics, (16), 503–512. https://doi.org/10.1007/s12687-025-00809-z

10. Cyranoski, D. (2019). Russian biologist plans more CRISPR-edited babies. Nature, 570(7760), 145–146. https://doi.org/10.1038/d41586-019-01770-x

11. Greely, H. (2011). Get ready for the flood of fetal gene screening. Nature, (469), 289–291. https://doi.org/10.1038/469289a

12. Greely, H.T. (2019). CRISPR’d babies: human germline genome editing in the «He Jiankui affair». Journal of Law and the Biosciences, 6(1), 111–183. https://doi.org/10.1093/jlb/lsz010

13. Grozinger, L., Amos, M., Gorochowski, T.E., Carbonell, P., Oyarzún, D.A., Stoof, R., ... Goñi-Moreno, A. (2019). Pathways to cellular supremacy in biocomputing. Nature Communications, 10(1), 5250. https://doi.org/10.1038/s41467-019-13232-z

14. Grozinger, L., Cuevas-Zuviría, B., Goñi-Moreno, Á. (2025). Why cellular computations challenge our design principles. Seminars in Cell & Developmental Biology, 171, 103616. https://doi.org/10.1016/j.semcdb.2025.103616

15. Jia, S., Lv, H., Li, Q., Fan, C., Wang, F. (2025). DNA-based biocomputing circuits and their biomedical applications. Nature Reviews Bioengineering, 3(7), 535–548. https://doi.org/10.1038/s44222-025-00303-8

16. Katz, E. (Ed.). (2021). DNA-and RNA-based Computing Systems. John Wiley & Sons. https://doi.org/10.1002/9783527825424

17. Landman, W., Schüklenk, U. (2005). UNESCO ‘declares’ universals on bioethics and human rights–many unexpected universal truths unearthed by UN body. Developing World Bioethics, 5(3), iii–vi. https://doi.org/10.1111/j.1471-8847.2005.00115.x

18. Li, J., Mao, C., Wang, S., Li, X., Luo, X., Wang, D., ... Jiang, X. (2025). A compact cassette tape for DNA-based data storage. Science Advances, 11(37), eady3406. https://doi.org/10.1126/sciadv.ady3406

19. McFarland R., Hyslop L.A., Feeney Catherine M., Pillai R.N., Blakely E.L., … Turnbull D.M. (2025) Mitochondrial Donation in a Reproductive Care Pathway for mtDNA Disease. New England Journal of Medicine, 393(5), 461–468. https://doi.org/10.1056/NEJMoa2503658

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

21. Nurk, S., Koren, S., Rhie, A., Rautiainen, M., Bzikadze, A.V., Mikheenko, A., ... Phillippy, A. M. (2022). The complete sequence of a human genome. Science, 376(6588), 44–53. https://doi.org/10.1126/science.abj6987

22. Samuel, G.N., Farsides, B. (2017). The UK’s 100,000 Genomes Project: manifesting policymakers’ expectations. New Genetics and Society, 36(4), 336–353. https://doi.org/10.1080/14636778.2017.1370671

23. Sanghavi K., Cohn B., Prince A.E.R., Feero W.G., Ryan K.A., Spector-Bagdady K., Uhlmann W.R., Lee C., Roberts J.S., Mathews D.J.H. (2022). Voluntary workplace genomic testing: wellness benefit or Pandora’s box? NPJ Genomic Medicine, 7(1), 5. https://doi.org/10.1038/s41525-021-00276-8

24. Tarasyants, E.V. (2011). Towards accession of Russia to the Convention on Human Rights and Biomedicine. Moscow Journal of International Law, (2), 65–77. (In Russ.). https://doi.org/10.24833/0869-0049-2011-2-65-77

25. Taylor, A. (2004). Governing Globalization of Public Health. The Journal of Law, Medicine and Ethics, 32(3), 500–508. https://doi.org/10.1111/j.1748-720x.2004.tb00163.x

26. Wolinsky, H. (2006). Bioethics for the world: UNESCO's Universal Declaration on Bioethics and Human Rights has far‐reaching goals, and has met with widespread opposition. EMBO Reports, 7(4), 354–358. https://doi.org/10.1038/sj.embor.7400670

27. Wu, L., Kong, X. (2023). A study on the normative path of ethics review in China: based on the perspective of Panopticism. Frontiers in Medicine, 10, 1268046. https://doi.org/10.3389/fmed.2023.1268046

28. Zaremba, A.G., Rychikhina, E.M. (2023). Analysis of the provisions of national and EAEU legislation regulating pharmaceuticals before and after 1 January 2026. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. Bulletin of the Scientific Centre for Expert Evaluation of Medicinal. Products. Regulatory Research and Medicine Evaluation, 13(4), 586–600. (In Russ.). https://doi.org/10.30895/1991-2919-2023-13-4-586-600