PHILOSOPHICAL AND LEGAL CONCEPTUALIZATION OF THE NORMATIVE REGULATION OF INNOVATIVE MEDICAL TECHNOLOGIES

Abstract

In the contemporary context of the rapid advancement of biomedical technologies, law emerges not merely as a regulator of social relations but also as a guarantor of the observance of fundamental human rights. Reproductive technologies, genetic engineering, and the application of artificial intelligence in healthcare generate novel challenges for the legal system, which must ensure a delicate balance between scientific progress and the protection of human dignity, autonomy, and personal security. A philosophical-legal approach in this regard provides the conceptual foundation that delineates the permissible boundaries of human intervention into nature, while bioethics establishes a value system integrated into legal regulation, thereby safeguarding the principles of justice, liberty, non-maleficence, and respect for human dignity. International instruments, such as the UNESCO Universal Declaration on Bioethics and Human Rights (2005), the Council of Europe Convention on Human Rights and Biomedicine (Oviedo, 1997), the Declaration of Helsinki (WMA, 2013), and the CIOMS International Ethical Guidelines (2016), enshrine universal ethical and legal benchmarks that must be implemented within national legal frameworks. At the same time, Ukrainian legislation develops in a fragmented manner: separate laws exist on transplantation, healthcare, and reproductive technologies, yet there is no unified codified act that systematically regulates issues of bioethics and innovative medical practices. This results in legal lacunae and complicates the implementation of international standards, thereby necessitating comprehensive reform of medical law and the establishment of a national Bioethical Code. Accordingly, this study is aimed at analyzing the philosophicallegal foundations of bioethics, examining international and national normative acts, identifying the challenges of legal regulation of innovative medical technologies, and formulating proposals for the improvement of Ukrainian legislation.