The Impact of the Legal Nature of Human Biological Material on Compensation Mechanisms in Case of Its Loss by a Biobank

Author information:

Anton Donets
PhD in Law, assistant professor, assistant of the department of civil law Yaroslaw Mudryi National Law University, Kharkiv, Ukraine
ORCID ID: https://orcid.org/0000-0003-3798-2311

Keywords: storage contract, civil liability, compensation for loss of human biomaterials, biomedical technologies, loss of chance, human embryos, cryopreservation, bioban

Download PDF
Обкладинка. 9-й випуск

Abstract

The relevance of this study arises from the expanding use of biobanking and cryopreservation technologies for storing human biomaterials, including cells, tissues, and embryos. These practices generate complex civil law relationships between individuals, medical institutions, and biobanks and raise significant questions concerning the legal regime of human biomaterials and the legal consequences of their loss. The issue is particularly important because such materials may possess not only medical and reproductive value but also considerable personal significance for the individuals involved. The purpose of this article is to analyse how the legal nature of human biomaterials affects the determination of compensation when such materials are lost by a biobank and to identify the specific features of civil liability in these legal relationships. The methodological framework combines formal legal analysis, comparative legal method, and systemic structural analysis. These approaches are supplemented by an examination of judicial practice and doctrinal discussions concerning the legal status of human biomaterials and the mechanisms used to compensate damage. The article identifies the specific characteristics of legal relations arising from the storage of human biomaterials in biobanks and examines common violations occurring in cryopreservation practices. It also analyses doctrinal and judicial approaches to determining the legal status of embryos and other biological materials. The research demonstrates that the legal nature of human biomaterials directly influences the classification of harm and the choice of compensation mechanisms. The study concludes that traditional models of pecuniary damages may be insufficient where unique biological samples are lost. In such cases, broader compensatory mechanisms should be considered, including the possible adaptation of the loss of chance doctrine. This article presents the results of a comprehensive study on the preservation of human biomaterials, preliminary findings of which have been published in the author’s other works.

How to Cite

In accordance with DSTU 8302:2015:
Донець А. Вплив правової природи біоматеріалу людини на компенсаційні механізми у разі його втрати біобанком. Цивілістична платформа. 2026. № 2 (9). С. 50-71. https://doi.org/10.69724/2786-8834-2026-9-2-50-71

According to the international style of APA:
Donets, A. (2026) The Impact of the Legal Nature of Human Biological Material on Compensation Mechanisms in Case of Its Loss by a Biobank. С. P. Journal, 2 (9). https://doi.org/10.69724/2786-8834-2026-9-2-50-71 [in Ukrainian].

References

  1. Anisimova, H., Donets, O., Donets, A., Anisimov, K., & Arjjumend, H. (2025). Modern approaches to unifying compensatory and legal mechanisms in the process of forming a legal category of ecological damage. Grassroots Journal of Natural Resources, 8(2), 728–729. https://doi.org/10.33002/nr2581.6853.080234
  2. Cabinet of Ministers of Ukraine. (2016). Resolution No. 286: Licensing conditions for the conduct of economic activity of banks of cord blood and other human tissues and cells. https://zakon.rada.gov.ua/laws/show/286-2016-п
  3. Civil Code of Ukraine, (2003). Law of Ukraine 435-IV https://zakon.rada.gov.ua/laws/show/435-15
  4. Code of Federal Regulations. (n.d.). https://www.ecfr.gov
  5. Commission Directive 2006/86/EC implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells. (2006). https://eur-lex.europa.eu/eli/dir/2006/86/oj
  6. Cornell, M., & Baron, T. (2023). The law and ethics of a property rights approach to frozen embryo disputes. Legal Studies. https://doi.org/10.1017/lst.2023.33
  7. Court of Appeals of Ohio. (2019). Case No. 107406. https://caselaw.findlaw.com/court/oh-court-of-appeals/1996552.html
  8. Crockin, S., Altman, A. B., & Rinehart, L. (2022). Post-Dobbs legal conundrums surrounding preimplantation in vitro fertilization embryo dispositions. Fertility and Sterility. https://doi.org/10.1016/j.fertnstert.2022.10.033
  9. Daar, J. (2020). Legal liability landscape and the person/property divide. F&S Reports, 1(2), 61–62. https://doi.org/10.1016/j.xfre.2020.08.004
  10. 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. (2004). https://eur-lex.europa.eu/eli/dir/2004/23/oj
  11. Dobson v. North Tyneside Health Authority, [1997] 1 WLR 596 (EWCA Civ).
  12. Donets, A. H. (2025). Liability under a storage contract. In I. V. Spasybo-Fatieieva (Ed.), Doctrine of civil liability(p. 582). EKUS.
  13. Draft Law of Ukraine No. 14056 on amendments to the Civil Code of Ukraine in connection with the recodification of Book One. (2025). https://itd.rada.gov.ua/09704c46-85c4-4a84-8d97-e385b82430b6
  14. Ethics Advisory Board, Department of Health, Education and Welfare. (1979). HEW support of research involving human in vitro fertilization and embryo transfer: Report and conclusions. https://repository.library.georgetown.edu/handle/10822/559350
  15. European Society of Human Reproduction and Embryology. (n.d.). ESHRE guidelines, consensus documents and recommendations. https://www.eshre.eu/Guidelines-and-Legal
  16. Health Council of the Netherlands. (2023). The 14-day rule in the Dutch Embryo Act (Publication No. 2023/16e). https://www.healthcouncil.nl/documents/advisory-reports/2023/10/31/the-14-day-rule-in-the-dutch-embryo-act
  17. Herring, J., & Chau, P.-L. (2013). Interconnected, inhabited and insecure: Why bodies should not be property. Journal of Medical Ethics, 40(1), 39–43. https://doi.org/10.1136/medethics-2012-100904
  18. Klock, S. C., & Lindheim, S. R. (2022). Disposition of unused cryopreserved embryos: Opportunities and liabilities. Fertility and Sterility. https://doi.org/10.1016/j.fertnstert.2022.10.036
  19. Korobtsova, N. V. (2022). Legal status of human biomaterial. Problems of Legality, 156, 28–39. https://doi.org/10.21564/2414-990x.156.254433
  20. Krushelnytska, H. L. (2020). Cryopreserved embryos in vitro as objects of civil rights. Chasopys Tsyvilistyky, (37), 36–41. https://doi.org/10.32837/chc.v0i37.347
  21. Kvit, N. M., & Kinash, D. V. (2023). Legal regime of human anatomical and biological materials and embryos as objects of civil legal relations. New Ukrainian Law, 1, 73–80. https://doi.org/10.51989/nul.2023.1.9
  22. Оn copyright and related rights. (2022). Law of Ukraine № 2811-IX https://zakon.rada.gov.ua/laws/show/2811-20(accessed: 01.02.2026) [in Ukrainian].
  23. Оn prohibition of reproductive human cloning. (2004). Law of Ukraine https://zakon.rada.gov.ua/laws/show/2231-15 (accessed: 01.02.2026) [in Ukrainian].
  24. Letterie, G. (2023). Legal personhood and frozen embryos: Implications for fertility patients and providers in post-Roe America. Journal of Law and the Biosciences, 10(1). https://doi.org/10.1093/jlb/lsad006
  25. Letterie, G., & Fox, D. (2020). Lawsuit frequency and claims basis over lost, damaged, and destroyed frozen embryos over a 10-year period. F&S Reports, 1(2), 78–82. https://doi.org/10.1016/j.xfre.2020.06.007
  26. Mason, J. K., & Laurie, G. T. (2001). Consent or property? Dealing with the body and its parts in the shadow of Bristol and Alder Hey. Modern Law Review, 64(5), 710–729. https://doi.org/10.1111/1468-2230.00347
  27. Matsuyama v. Birnbaum, 452 Mass. 1 (Mass. 2008).
  28. Ministry of Health of Ukraine. (2013, September 9). On approval of the Procedure for the use of assisted reproductive technologies in Ukraine (Order No. 787). https://zakon.rada.gov.ua/laws/show/z1697-13
  29. Moutos, C. P., Lahham, R., & Phelps, J. Y. (2019). Cryostorage failures: A medicolegal review. Journal of Assisted Reproduction and Genetics, 36(6), 1041–1048. https://doi.org/10.1007/s10815-019-01478-x
  30. Parrillo v. Italy, App. No. 46470/11 (European Court of Human Rights, 2015).
  31. Public contract for the storage of biological material. (2022). https://instituteofcelltherapy.com/wp-content/uploads/2022/12/2022.pdf
  32. R v. Kelly, [1999] 2 WLR 384 (EWCA Crim).
  33. Regulation (EU) 2016/679 of the European Parliament and of the Council (General Data Protection Regulation). (2016). https://eur-lex.europa.eu/eli/reg/2016/679/oj
  34. Resolution of the Plenum of the Supreme Court of Ukraine No. 4 on judicial practice in cases of compensation for moral (non-pecuniary) damage. (1995). https://zakon.rada.gov.ua/laws/show/v0004700-95
  35. Rinehart, L. A. (2021). Storage, transport, and disposition of gametes and embryos: Legal issues and practical considerations. Fertility and Sterility, 115(2), 274–281. https://doi.org/10.1016/j.fertnstert.2020.11.025
  36. Shyshko, I. M. (2025). The legal status of the human embryo and its influence on the legal regulation of biomedical research on human embryos. Uzhhorod National University Herald. Series: Law, 87(4), 364–370. https://doi.org/10.24144/2307-3322.2025.87.4.57
  37. Simon, J., et al. (2007). A legal framework for biobanking: The German experience. European Journal of Human Genetics, 15(5), 528–532. https://doi.org/10.1038/sj.ejhg.5201810
  38. Strech, D., et al. (2016). A template for broad consent in biobank research: Results and explanation of an evidence and consensus-based development process. European Journal of Medical Genetics, 59(6–7), 295–309. https://doi.org/10.1016/j.ejmg.2016.04.002
  39. Supreme Court of Alabama. (2024). LePage v. Center for Reproductive Medicine, P.C., No. SC-2022-0515. https://law.justia.com/cases/alabama/supreme-court/2024/sc-2022-0579.html
  40. Texas Supreme Court declines opportunity to hear personhood case. (n.d.). JD Supra. https://www.jdsupra.com/legalnews/texas-supreme-court-declines-8227520
  41. The legal limbo of lost embryos. (2019). Petrie-Flom Center, Harvard Law School. https://petrieflom.law.harvard.edu/2019/07/08/the-legal-limbo-of-lost-embryos
  42. VO v. France, App. No. 53924/00 (European Court of Human Rights, 2004).
  43. Yearworth v. North Bristol NHS Trust, [2009] EWCA Civ 37; [2010] QB 1.