Legal Regulation of Biobank Activities in Ukraine: Protection of Genetic Information and Rights of Biological Material Donors

The article examines current problems of legal regulation of biobank activities in Ukraine in the context of protecting genetic information and rights of biological material donors. The modern state of Ukrainian legislation in the field of biobanking and its compliance with European standards are analyzed. The main gaps in legal regulation are identified and ways to eliminate them are proposed. The necessity of adopting a special law on biobanks in Ukraine is substantiated. The study reveals that the legal regulation of biobanks in Ukraine is at an initial stage of development and requires significant improvement. The absence of special legislative regulation creates risks to the protection of donors' rights and may hinder the development of biomedical research in the country. Key problems include: lack of special legislative regulation of biobanks, insufficient protection of genetic information as a special category of personal data, unregulated issues of informed consent for long-term research, the absence of a clear legal status of donors and mechanisms to ensure their rights. The analysis of international experience shows the diversity of approaches to legal regulation of biobanks in different European countries. Some countries have adopted special laws on biobanks, while others regulate biobank activities within the framework of general legislation on personal data protection and medical law. The GDPR directly defines genetic data as a special category of personal data, the processing of which is generally prohibited except in cases of special grounds, including the consent of the data subject or necessity for scientific research purposes. The article proposes comprehensive solutions including: adoption of a special law "On Biobanks and Research Activities Involving Humans"; amendments to the Civil Code of Ukraine to add Article 179¹ "Biological Material"; improvement of the Law "On Personal Data Protection" to define genetic data as a separate category; development of a system of informed consent forms; creation of an ethical oversight system; ratification of international agreements in biomedicine. The research concludes that solving these problems requires a comprehensive approach that will ensure proper protection of citizens' rights and create favorable conditions for the development of biomedical research in Ukraine in accordance with European standards. Prospects for further research include development of specific draft regulations, study of international standards application practices in biobanking, and analysis of ethical aspects of artificial intelligence use in biobanks.