INTERNATIONAL LEGAL APPROACHES TO THE HARMONISATION OF BIOETHICAL STANDARDS IN MEDICINE
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Annotatsiya
INTERNATIONAL LEGAL APPROACHES TO THE HARMONISATION OF BIOETHICAL STANDARDS IN MEDICINE. Med Law (2026) 45:2:247-286 https://doi.org/10.63776/medlaw2026.45.2.bioethics.standard Ledja Burnazi Mitllari*, Konrad Brodaczewski**, Donokhon Achilova***, Vadym Borovykov****, Piotr Kusznieruk***** Abstract: The aim of the study was to determine the effectiveness of international legal mechanisms for harmonising bioethical standards and to establish patterns of their functioning in the context of technological progress. The research was conducted using systemic, comparative legal, and empirical methods based on the analysis of primary documents from international organisations and statistical data. The evolution of the global bioethical framework was established, from the initial declarative principles of the United Nations Educational, Scientific and Cultural Organisation (UNESCO) to the contemporary monitoring system, which includes seven mechanisms for ensuring compliance with ethical standards. The uniqueness of the European regional model was highlighted through the creation of the first legally binding international instrument in biomedical ethics – the Oviedo Convention, ratified by 29 of 37 signatory countries, or 78%. The study identified eight quantitative metrics for evaluating the success of harmonisation, which showed significant discrepancies between international standards and their practical implementation. Empirical analysis revealed that 32 countries have established national bioethics committees under the UNESCO support programme, with an average readiness score for ethical management of artificial intelligence (AI) standing at 64 out of 100. Research into the national practices of Ukraine, Albania, Ireland, and Uzbekistan revealed diverse approaches to implementing universal principles, taking into account socio-cultural differences. The results conceptualised modern bioethical harmonisation as a multidimensional process combining normative regulation with institutional support, creating a methodological foundation for systematic monitoring of international coordination of ethical standards in medicine. Keywords: international organisations, innovation, implementation, data protection, digital technologies, institutional support. You can access the full article if your institution is subscriber. You can log in via your Institution https://heinonline.org/HOL/Welcome If your Institution is not subscriber and want to request a quote for the article, please visit the site below: https://home.heinonline.org/content/medicine-and-law/ If you are an individual interested in downloading a few documents or receiving short-term access, please visit our short-term subscriptions page. You can purchase 24-hour, 48-hour, or 1-week access to select HeinOnline databases. https://home.heinonline.org/request-a-quote-or-trial/?database=Medicine+and+Law
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