Annotation

Purpose. Reconstruction of the stages of formation of legal regulation of biolaw and bioethics in the Republic of South Africa over the past forty years, characterization of the current system and determination of its development prospects. Methods: general scientific methods (analysis, synthesis, systems approach); specific legal methods (historical-legal, formal-legal, comparative-legal). Results: regulation has evolved from fragmented apartheid-era legislation and discriminatory voluntary guidelines to a constitutionally grounded statutory system (section 12(2)(c) of the 1996 Constitution, National Health Act of 2003); decisions of research ethics committees are binding in the administrative-regulatory sense yet subordinate to legislation and judicial review; the current stage constitutes a reflexive restructuring with a reform agenda concerning minors' consent, heritable genome editing, end-of-life decisions and artificial intelligence.