Transforming the Legal Regulation of Regenerative Medicine: Conflict of Laws and Resolution Mechanisms

This article examines the legal challenges arising from the rapid development of regenerative medicine. The analysis focuses on gene therapy and cell therapy, which are subject to dual regulation under Federal Law No. 180-FZ of June 23, 2016 “On Biomedical Cell Products” and Federal Law No. 61-FZ of April 12, 2010 “On the Circulation of Medicines”. It also considers the emerging international legal framework governing the circulation of medicines within the Eurasian Economic Union (EAEU). The aim of this study is to identify systemic gaps in the legal regulation of gene and cell therapies resulting from the dual regulatory framework (Federal Laws No. 180-FZ and No. 61-FZ) and conflicts with the EAEU law. The importance of implementing flexible legal mechanisms is emphasized, including “hospital exception” and experimental legal regimes, which can facilitate the adoption of innovative regenerative medicine technologies.
The timely and effective implementation of cell therapy products and regenerative medicine approaches necessitates the development of improved legal approaches to regulating innovative treatments. This article identifies key conflicts of law that hinder the adoption of new therapeutic methods. A systemic analysis of legal acts governing regenerative medicine, with a specific focus on cell and gene therapy, is conducted. Using a specialized legal approach, recommendations are formulated for improving legislation to ensure the accelerated adoption of regenerative medicine products, including through the application of “hospital exception” widely used in international practice (which explains the use of a comparative legal approach). The article demonstrates that gene therapy extends beyond medicinal products to include human genome editing, which is increasingly viewed as a potential experimental treatment for certain genetic diseases. Such modern technologies as CRISPR/Cas9 (“genetic scissors”) fall outside existing regulatory frameworks. The article highlights the specific features of legal regulation governing cell therapy products. The need for a flexible regulatory approach and the introduction of experimental legal regimes for regenerative medicine technologies is substantiated.

1. Bulgin, D.V., Kovtun, A.L., Reshetov, I.V., Radomskaya, E.Yu. (2023). Prospects for fabrication of artificial human tissues and organs based on 3D bioprinting. Russian Journal of Transplantology and Artiflcial Organs, 25(2), 63–81. (In Russ.). https://doi.org/10.15825/1995-1191-2023-2-63-81

2. Cohen, J. (2019, October 21). Embattled Russian scientist sharpens plans to create gene-edited babies. Science. https://doi.org/10.1126/science.aaz9337

3. Cornetta, K., Bonamino, M., Mahlangu, J., Mingozzi, F., Rangarajan, S., Rao, J. (2022). Gene therapy access: Global challenges, opportunities, and views from Brazil, South Africa, and India. Molecular Therapy, 30(6), 2122–2129. https://doi.org/10.1016/j.ymthe.2022.04.002

4. Cyranoski, D. (2019). Russian biologist plans more CRISPR-edited babies. Nature, 570(7760), 145–147. https://doi.org/10.1038/d41586-019-01770-x

5. Daneshi, N., Bahmaie, N., Esmaeilzadeh, A. (2022). Cell-Free Treatments: A New Generation of Targeted Therapies for Treatment of Ischemic Heart Disease. Cell Journal, 24(7), 353–363. https://doi.org/10.22074/cellj.2022.7643

6. Fletcher, S., Jenner, K., Holland, M., Khair, K. (2024) Barriers to gene therapy, understanding the concerns people with haemophilia have: an exigency sub-study. Orphanet Journal of Rare Diseases, 19(1), 59. https://doi.org/10.1186/s13023-024-03068-2

7. Francis, N., Aho, J., Ben-Nun, I. F., Bharti, K., Dianat, N., Makovoz, B., ... Allickson, J. (2025). Scaling up pluripotent stem cell-based therapies - considerations, current challenges and emerging technologies: perspectives from the ISCT Emerging Regenerative Medicine Working Group. Cytotherapy, 27(9), 1031–1042. https://doi.org/10.1016/j.jcyt.2025.04.058

8. Gerasimov, E., Donoghue, M., Bilenker, J., Watt, T., Goodman, N., Laetsch, T. W. (2020, May). Before It's Too Late: Multistakeholder Perspectives on Compassionate Access to Investigational Drugs for Pediatric Patients With Cancer. American Society of Clinical Oncology Educational Book, 40, e218–e227. https://doi.org/10.1200/EDBK_278995

9. Gomon, Yu.M., Kolbin, A.S. (2024). Advanced-Therapy Medicinal Products: Challenges for Implementation in Pediatric Clinical Practice. Current Pediatrics, 23(1), 34–47. (In Russ.). https://doi.org/10.15690/vsp.v23i1.2654

10. Gould, P., Salam, T., Kimberly, L., Bateman-House, A., Fernandez Lynch, H. (2022). Perspectives of academic oncologists about offering expanded access to investigational drugs. JAMA Network Open, 5(11), e2239766. https://doi.org/10.1001/jamanetworkopen.2022.39766

11. 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

12. Ivaskiene, T., Mauricas, M., Ivaska, J. (2017). Hospital exemption for advanced therapy medicinal products: issue in application in the European Union member states. Current Stem Cell Research & Therapy, 12(1), 45–51. https://doi.org/10.2174/1574888x11666160714114854

13. Korsakov, I.N., Nadelyaeva, I.I., Eremin, I.I., Pulin, A.A., Kotenko, K.V., Zorin, V.L. (2017). Analysis of the regenerative medicine products market. Genes & Cells, 12(1), 72–89. (In Russ.). https://doi.org/10.23868/gc120667

14. Markarian, J. (2023). Considering the Promises of Point-of-Care Manufacturing. BioPharm International, 36(11), 8–11. Available at: https://www.biopharminternational.com/view/considering-the-promises-of-point-of-care-manufacturing

15. Merkulov, V.A., Melnikova, E.V. (2019). Biomedical Cell Products or High-Tech Drugs? BIOpreparations. Prevention, Diagnosis, Treatment, 19(2), 94–98. (In Russ.). https://doi.org/10.30895/2221-996X-2019-19-2-94-98

16. Patole, V., Tupe, A., Tanpure, S., Swami, R., Vitkare, V., Jadhav, P. (2024). Nanorobotic artificial blood components and its therapeutic applications: A minireview. Irish Journal of Medical Science, 193(3), 1641–1650. https://doi.org/10.1007/s11845-024-03617-5

17. Prado-Yupanqui, J.W., Ramírez-Orrego, L., Cortez, D., Vera-Ponce, V.J., Chenet, S.M., Tejedo, J.R., TapiaLimonchi, R. (2025). The hidden power of the secretome: therapeutic potential on wound healing and Cell-Free regenerative medicine – A systematic review. International journal of molecular sciences, 26(5), 1926. https://doi.org/10.3390/ijms26051926

18. Romanovsky, G.B., Romanovskaya, O.V. (2024). Law and 3D bioprinting: problems, risks, prospects. Journal of Russian Law, 28(12), 108–121. (In Russ.). https://doi.org/10.61205/S160565900031844-2

19. Sharma, R., Kashyap, M., Zayed, H., Krishnia, L., Kashyap, M.K. (2025). Artificial blood—hope and the challenges to combat tumor hypoxia for anti-cancer therapy. Medical & Biological Engineering & Computing, 63(4), 933–957. https://doi.org/10.1007/s11517-024-03233-6

20. Wang, V., Gauthier, M., Decot, V., Reppel, L., Bensoussan, D. (2023). Systematic review on CAR-T cell clinical trials up to 2022: academic center input. Cancers, 15(4), 1003. https://doi.org/10.3390/cancers15041003

21. 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. Regulatory Research and Medicine Evaluation, 13(4), 586–600. (In Russ.). https://doi.org/10.30895/1991-2919-2023-13-4-586-600

22. Zoricheva, A.S., Zvonova, E.A., Agapova, L.S., Lykova, M.S., Markova, O.A., Leonov, V.S. (2024). Experience in the production and clinical application of the cell-based medicinal product Easytense® for the repair of cartilage defects of the human knee. Biological Products. Prevention, Diagnosis, Treatment, 24(2), 172–187. https://doi.org/10.30895/2221-996X-2024-24-2-172-187