Editorial: Bringing closer to standardization of legal doctrine for challenging medico-legal issues

Abstract

The impact of globalisation should go beyond trading and commerce. With increasing population mobility, the impact of globalisation can also affect health and well-being. The determinants of health require stronger, mutually reinforcing linkages between law and health . Different jurisdictions have their own sets of law, codes of practice and regulations on healthcare ethics and law so the determinants of health should take a boarder lens not just the local perspectives. Research examining the legal doctrines and philosophy of bioethics on contentious medico-legal issues across jurisdictions would facilitate development of mechanism to harmonise bioethical and legal standards globally. Paper by Choudhourly highlights the standard of informed consent still doctor-centred rather than patient-centred applied by Indian judiciary. Taken reference from leading cases, Whitaker and Montgomery , it would better define the standard of informed consent emphasising on patient autonomy adopting prudent patient test. This would enable standardisation of what constitute valid informed to avoid ambiguity of defective consent and forged consent as forged consent would lead to criminal liability. The public would be better protected from defective and/or forged consent irrespectively where they seek medical help. Paper by Mitlari et al has identified the patterns in the functioning of international legal mechanisms for harmonising bioethical standards and aims to integrate the medico-legal synthesis of fragmented international, regional, and national bioethical instruments. The paper has provided insights how initial declarations can evolve to become formalised protocols for international reference. This would pave the way to develop unified tools assessing how effective different national bioethical systems can uphold the agreed international principles and standards. There is a pressing need with advancement of scientific technology in healthcare. Process of organ donation and transplantation would lead to potential risks of human rights violations arising from coercion, commericialisation, discrimination without a robust legal framework to ensure ethical standard. Zzhumaev et al analysed the impact of international standards on national transplantation legislation, including legal protection mechanisms for donors and recipients . The findings can enhance national laws, boost law enforcement’s efficiency, and educate the public and professional communities about this intricate and morally important subject. The study substantiated the need for harmonisation of national legislation with international standards to ensure comprehensive protection of human rights in this sensitive area. Paper by Roszkiewicz and Borysiak points out that there is no universal and precise definition of medical standards . The paper highlights that apart from ex lege binding standards, a legal provision, there is also ex auctoritate binding standards, not from the law, but from the high esteem of a scientific institution described as persuasive medical standards or private medical standards. The standards are typically taken into account by medical professionals in their professional practice, and sometimes also by courts in civil, criminal or disciplinary cases as in Germany, France, Switzerland and England, and the paper has provided a synthetic overview of those standards, their sources and the institutions that create them in those typical European jurisdictions . CT-Luso is an ethical and regulatory capacity-building project in the field of clinical trials in Portuguese-speaking African countries (PALOPs) and the comparative legal analysis of five PALOP by Barbosa et al has revealed significant regulatory heterogeneity and differing levels of development . Based on these findings, CT-Luso proposed a roadmap to align national legislation with international best practices and harmonize legal frameworks across partner countries, establishing the foundation for a PALOP clinical trials hub. This can fosters regional integration, and supports global health innovation. The circulation of counterfeit medicines poses a serious threat to public health, particularly in countries or territories which are densely populated. Fazal et al examines the effectiveness of the existing legislative and enforcement framework in addressing counterfeit medicines within Delhi National Capital Region (densely populated region) . The study evaluates the effectiveness of the existing legal provisions implemented to combat counterfeit medicines, key gaps in enforcement and regulation, and the legislative and policy reforms required to strengthen the current framework. The study can facilitate a region-specific, data-informed analysis so targeted recommendations for improving regulatory effectiveness and safeguarding public health can be proposed. Legislative and institutional reform is needed to shift from reactive detection to proactive, coordinated, and technology-enabled regulation. Public advertisement of prescription medicines outside narrowly defined professional channels is prohibited in Russia as described in the paper by Kolomietc and Grigoryev . While this can be justified by reference to beneficence, non-maleficence, and the clinical gatekeeping role of the physician, reform is desirable to strengthen legal certainty, proportionality, and equitable access to reliable health-related information. Surrogacy is highly contentious issue and there have been ongoing development in law and always with heated debates for justifiability, equity and fairness. Abrosimova and Krestinina analyze the main changes of Russian law on surrogacy, their actual consequences, as well as legal and medical commentary, providing an assessment of the new regulations and identifying the most contentious and problematic issues associated with them. There are still no provisions to address sensitive issues such as legal liability of surrogate mothers and contractual liability. There are rooms for comparative legal analysis to balance the interests of all parties involved, and encourage the conclusion of detailed agreements primarily to protect the child. Medicine and Law is an international publication addressing issues related to medical law, medical ethics and bioethics across different jurisdictions. It provides a good platform to discuss recent developments in any specific topics of medical law of different parts of the world which would serve as guiding practice for health and/or legal professionals globally. In the upcoming special thematic issue, it will address global health security and law.