Janusz Roszkiewicz*, Witold Borysiak** The Relevance of the Persuasive Medical Standards for Private Law Liability in Comparative Perspective** (short running title: The Relevance of the Persuasive Medical Standards) Med Law (2026) 45:2:327-352 https://doi.org/10.63776/medlaw2026.45.2.medical.standard Abstract: There is no universal and precise definition of medical standards. However, it is commonly accepted that they are ‘signposts’ based on Evidence-Based Medicine (EBM) that guide medical practitioners in the process of treatment and help them to set realistic goals for a particular patient in a particular condition. According to the criterion of legal significance, they can be divided into ex-lege binding standards, the force of which results from a legal provision, and ex-auctoritate binding standards, the force of which results from the high esteem of a scientific institution that created them rather than from law. In a comparative perspective there exist centralised and decentralised systems of creation of the persuasive medical standards and they are adopted by different bodies and institutions. However, it is also commonly accepted that failure to comply with them may determine the existence of liability in tort law (even though they cannot be formally classified as part of a legal system). Keywords: medical law, comparative law, medical standards, persuasive medical standards, ex auctoritate binding medical standards, private medical standards, sources of medical law, private law liability, liability in tort, duty of care 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
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
Prescription Medicine Advertising in Russia: A Quest for Ethical Regulation Med Law (2026) 45:2:407-438 https://doi.org/10.63776/medlaw2026.45.2.advertising.medicine Anna Kolomietc* and Timur Grigoryev** Abstract: This article examines how Russian law regulates advertisement of prescription medicines and how enforcement practice addresses the tension between patient access to information, public health protection, and pharmaceutical market incentives. The study combines doctrinal analysis of Russian advertising and medicines legislation with a comparative review of European Union and United States approaches and a qualitative analysis of selected enforcement materials of the Federal Antimonopoly Service of Russia. It argues that the Russian model relies on a restrictive public-health rationale: public advertisement of prescription medicines is largely excluded from mass communication, while limited informational disclosure may be tolerated only in narrowly framed contexts and only in a non-promotional form. The analysis further shows that enforcement practice focuses not only on express references to prescription products but also on associative techniques, including umbrella branding, dosage differentiation, packaging similarity, and digital dissemination strategies capable of redirecting consumer attention toward prescription-only medicines. The article concludes that Russian regulation reflects a risk-averse and predominantly paternalistic conception of pharmaceutical communication. This model can be justified by reference to harm prevention and clinical gatekeeping, but its long-term legitimacy depends on clear and predictable criteria for distinguishing neutral information from advertising, particularly in digital environments. Reform is desirable to strengthen legal certainty, proportionality, and equitable access to reliable health-related information. Keywords: Non-prescription medicine, medicine advertising regulation, Russian healthcare system, prescription medicine advertisement, Direct-to-consumer-advertising, Inappropriate advertising; Umbrella branding, Drug Promotion on social media; Pharmaceutical Marketing in Russia *Associate Professor, department of private international and civil law of Moscow State Institute of International Relations MGIMO (University), Ph.D in Law (MGIMO University) Arbitrator at the Russian Arbitration Center (RAC), Rapporteur at the International Commercial Arbitration Court at the Chamber of Commerce and Industry of the Russian Federation; Professional Mediator. Email: a.kolomiets@ my.mgimo.ru **Managing Partner at Tergrig FZE LLC, Ph.D in Law (MGIMO University) International expert in Pharmaceutical, Antimonopoly and Comparative Law; Email: info@tergrig.com 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
DETECTION WITHOUT DETERRENCE: A STUDY OF COUNTERFEIT MEDICINES AND REGULATORY EFFECTIVENESS IN DELHI–NCR Med Law (2026) 45:2:379-406 https://doi.org/10.63776/medlaw2026.45.2.counterfeit.medicine Syed Shiraz Fazal*, Avnish Singh ** and Twinkle Hussain*** Abstract The circulation of counterfeit medicines represents a significant public health and regulatory challenge in the Delhi National Capital Region (NCR), where dense population, complex supply chains and expanding pharmaceutical markets increase vulnerability to drug falsification. This study aims to assess the prevalence, patterns and regulatory response to counterfeit medicines in Delhi NCR, with specific focus on the implementation of the Drugs and Cosmetics Act, 1940. Using a mixed-method approach, the research analyzes enforcement data, reported seizures, inspection records and judicial outcomes, supplemented by secondary data from government reports and regulatory authorities. The findings indicate persistent gaps in detection, fragmented enforcement mechanisms, low conviction rates and regulatory ambiguities arising from the absence of a clear statutory definition of “counterfeit medicines.” Additionally, the study identifies emerging challenges linked to informal distribution networks and online drug sales within the region. Based on these findings, the paper argues that the current legislative and enforcement framework is insufficient to effectively address the scale and complexity of the problem in Delhi NCR. It proposes targeted reforms, including statutory clarification of drug categories, strengthening inter-agency coordination, enhancing surveillance mechanisms, and introducing stricter compliance requirements for digital pharmaceutical platforms. These measures are essential to improving regulatory effectiveness and safeguarding public health in the region. Keywords: Counterfeit medicines, legislative gaps, online drug sales, organized crime, public health. * Research Scholar, School of Law, Bennett University, Greater Noida, India Assistant Professor, Lloyd Law College, Greater Noida, India ** Assistant Professor, School of Law, Bennett University, Greater Noida, India *** Assistant Professor, Asian Law College, Noida, India Corresponding Author: Mr. S. S. Fazal, Department of Law, Lloyd Law College Plot No. 11, Knowledge Park II, Greater Noida, 201306, India Email: shirazfazal.sf@gmail.com 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
INTERNATIONAL LEGAL STANDARDS IN THE FIELD OF ORGAN DONATION AND THEIR IMPACT ON HUMAN RIGHTS PROTECTION Med Law (2026) 45:2:287-326 https://doi.org/10.63776/medlaw2026.45.2.organ.standard Ravshanbek Dzhumaev , Besnik Cerekja**, Konrad Brodaczewski***, Evgeni Nikolaev****, Gulmira Biialieva***** Abstract: In order to improve medical staff training and boost donor assistance, the study’s main goal was to address the lack of knowledge about donor legislation, its inefficient application, and contemporary concerns that call for legal amendments. The methodology of the study included such approaches as analysis of international legal sources and comparative legal analysis. Key international treaties, suggestions, and guidelines that were established by prominent organisations including the United Nations, the Council of Europe, and the World Health Organisation were covered in the study. Emphasis was placed on the concepts of fair distribution of donated organs, the prohibition of the commercial traffic in organs, the protection of medical data confidentiality, and voluntary and informed permission. The study analysed the impact of international standards on national transplantation legislation, including legal protection mechanisms for donors and recipients. Potential risks of human rights violations in the processes of donation and transplantation, including commercialisation, coercion and discrimination, are considered. The study substantiated the need for harmonisation of national legislation with international standards to ensure comprehensive protection of human rights in this sensitive area. The study underlined that a robust legal framework should serve to ensure ethical standards, clearly identify the rights and obligations of process participants, and set minimum standards of behaviour. This is necessary to create a transparent and efficient system of organ and tissue transplantation. The study’s practical relevance is based on the potential to use the findings to enhance national laws, boost law enforcement’s efficiency, and educate the public and professional communities about this intricate and morally important subject. Keywords: organ transplantation, presumption of consent, international documents, tissue transplantation, legal regulation. 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
