LEGAL NATURE OF MEDICAL SERVICES: SPECIFICS OF UKRAINIAN DOCTRINE.

The purpose of the article is to analyze the specifics of the Ukrainian doctrine regarding the legal nature of medical services and areas for improving legal regulation. The research is based on the analysis and comparison of Ukrainian and EU law, content analysis of the terminology of legal sources, legal positions of the Constitutional Court of Ukraine, scientific researches, description and generalization of existing achievements and issues in the field of legal regulation of healthcare services. Research methods are monographic analysis, systematic and structural analysis, comparative and legal analysis, linguistic analysis, content analysis, method of generalization. The need to unify the special categorical apparatus of Ukrainian legislation has been substantiated. It has been proved that due to the improvement of domestic legislation through the implementation of the norms of European private law, the doctrine and practice of legal regulation will correspond to the nature of the regulated relations. The content, structure, and specific features of legal relations for the provision of medical services in the Ukrainian legal system have been determined. The authors have made a conclusion about the private legal nature of medical services in the domestic legal doctrine. Recommendations have been made for the legislation of Ukraine, which regulates civil relations for the provision of medical services, regarding the introduction of special norms related to the personal non-property rights of the relations' participants, contractual representation of a patient, legal terms for the provision of medical services without obtaining the consent.

COMMENTARY: The Consumer Protection Act, 2019: A critical analysis from a medical practitioner's perspective.

The landmark judgment in the case of Indian Medical Association v VP Shantha in 1995 brought the medical profession under the ambit of the Consumer Protection Act, 1986. The Consumer Protection Act, 1986, was later repealed and replaced by the Consumer Protection Act, 2019. This article delves into the implications of the 2019 Act, highlighting significant changes in its scope, including the expansion of the definition of "consumer" and the incorporation of telemarketing and e-commerce within its ambit. Moreover, the amendments affect pecuniary jurisdiction, grounds for litigation, and introduce mediation cells, and the Central Consumer Protection Authority (CCPA). This article underscores concerns related to an increase in frivolous cases against medical practitioners and in defensive practice, ultimately impacting the overall quality of patient care. Recommendations for timely redressal and safeguards against unwarranted litigation are proposed to mitigate the adverse implications of the amended Act and ensure the well-being of both healthcare providers and patients.

How Do Policymakers Regulate AI and Accommodate Innovation in Research and Medicine?

In this Medical News article, JAMA Editor in Chief Kirsten Bibbins-Domingo, PhD, MD, MAS, and Alondra Nelson, PhD, the Harold F. Linder Professor at the Institute for Advanced Study, discuss effective AI regulation frameworks to accommodate innovation.

Critics Say New State "Conscience Laws" Give Physicians Carte Blanche to Refuse Patients.

This Medical News feature discusses state laws that protect physicians who refuse to provide certain services because of religious or moral beliefs.

The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Models.

This Viewpoint discusses how regulators across the world should approach the legal and ethical challenges, including privacy, device regulation, competition, intellectual property rights, cybersecurity, and liability, raised by the medical use of large language models.

Abortion Miscoding-Legal Risks for Clinicians and Hospital Systems.

This Viewpoint discusses the legal risks physicians and health care facilities may incur by miscoding a surgical or chemical abortion as a miscarriage to conceal an abortion procedure.

As Laws Restricting Health Care Surge, Some US Physicians Choose Between Fight or Flight.

In this Medical News article, 13 physicians and health care experts spoke with JAMA about the increasing efforts to criminalize evidence-based medical care in the US.

Court Intrusion Into Science and Medicine-The Mifepristone Decisions.

This Viewpoint discusses recent US court decisions on the availability of mifepristone, a drug used to terminate pregnancies, and how these conflicting court decisions affect the scientific process and decision-making of the US Food and Drug Administration.

Physicians Say an Idaho House Bill That Would Criminalize Administering mRNA Vaccines Is an Attack on the Medical Profession-Even If It Doesn't Become Law.

This Medical News article discusses a bill introduced in Idaho that would ban administering mRNA vaccines.

The CRISPR Patent Ruling and Implications for Medicine.

This Viewpoint discusses the CRISPR patent ruling, an ongoing patent dispute, and the implications for research and medical innovation.

Investigating Investigation Powers under the Health Practitioner Regulation National Law.

Investigators and inspectors appointed under the Australia Health Practitioner Regulation National Law play important roles by gathering and assessing evidence used in disciplinary proceedings and/or criminal prosecutions. In performing these roles, investigators and inspectors exercise "police-like" powers including coercive questioning and entry onto private property with or without a search warrant. The investigation process can add additional stress and anxiety for health practitioners who are subject to disciplinary proceedings. It is difficult for an aggrieved party to challenge the lawfulness of the exercise of an investigation power in a tribunal as tribunals lack jurisdiction to rule on the legality of an investigation power or the admissibility of evidence. This article explores the range of powers possessed by investigators and inspectors under the National Law and a number of issues relating to the exercise of those powers.

Законодательство стран Центральной Азии, регулирующее пересылку инфекционных материалов: Алматы, Казахстан, 29–30 марта 2023 г.: отчет о совещании.

Международные лабораторные сети, участвующие в эпиднадзоре, обеспечении готовности и проведении ответных мер, являются важным инструментом укрепления лабораторий, поскольку они служат платформой для обмена информацией и опытом, а также образуют систему перенаправления проб для первичных и подтверждающих исследований. После подготовительного совещания, состоявшегося в Стамбуле, Турция, в январе 2019 г., Европейское региональное бюро ВОЗ учредило Европейскую региональную лабораторную специальную группу по особо опасным патогенам. Чтобы облегчить пересылку инфекционных материалов и поддержать государства-члены в этих усилиях, 29–30 марта 2023 г. в Алматы, Казахстан, было проведено совещание, посвященное решению этих вопросов в странах Центральной Азии.Участники обсудили национальные и международные регламенты и соглашения о передаче материалов, регулирующие пересылку инфекционных материалов, таких как вирус оспы обезьян и SARS-CoV-2, и выделили пробелы и области,требующие поддержки в национальном законодательстве.

Workshop on transport of infectious substances legislation in central Asia 2023: Almaty, Kazakhstan, 29–30 March 2023: report.

International networks for laboratory surveillance, preparedness and response are an important tool for laboratory strengthening, because they serve both as a platform for sharing information and expertise and as a system for the referral of diagnostic specimens for primary and confirmatory testing. The WHO Regional Office for Europe established the European Regional Laboratory Task Force for High Threat Pathogens (Lab Task Force) following a preparatory meeting held in Istanbul, Türkiye in January 2019. In order to facilitate the shipment of infectious substances and to support Member States in this effort, a workshop dedicated to solving issues of sample transport in the central Asian subregion was held in Almaty, Kazakhstan, on 29 and 30 March 2023. Participants discussed national and international regulations and material transfer agreements governing the transport of infectious substances, particularly SARS-CoV-2 and monkeypox virus, and highlighted gaps and areas requiring support in their national legislations.

The Care Coordination Process: an opportunity to evaluate the impact of structural reform.

Nil.

Commercial Surrogacy: An Overview / Gestação de substituição comercial: Uma visão global

Abstract Objective Surrogacy is the process in which a woman carries and delivers a baby to other person or couple, known as intended parents. When carriers are paid for surrogacy, this is known as commercial surrogacy. The objective of the present work is to review the legal, ethical, social, and cultural aspects of commercial surrogacy, as well as the current panorama worldwide. Methods This is a review of the literature published in the 21st century on commercial surrogacy. Results A total of 248 articles were included as the core of the present review. The demand for surrogate treatments by women without uterus or with important uterine disorders, single men and same-sex male couples is constantly increasing worldwide. This reproductive treatment has important ethical dilemmas. In addition, legislation defers widely worldwide and is in constant change. Therefore, patients look more and more for treatments abroad, which can lead to important legal problems between countries with different laws. Commercial surrogacy is practiced in several countries, in most of which there is no specific legislation. Some countries have taken restrictive measures against this technique because of reports of exploitation of carriers. Conclusion Commercial surrogacy is a common practice, despite important ethical and legal dilemmas. As a consequence of diverse national legislations, patients frequently resort to international commercial surrogacy programs. As of today, there is no standard international legal context, and this practice remains largely unregulated.

Resumo Objetivo A gestação de substituição é o processo no qual uma mulher engravida e entrega um bebê a outra pessoa ou casal, conhecidos como pais pretendidos. Quando as gestantes são pagas, isto é conhecido como gestação de substituição comercial. O objetivo do presente trabalho é rever os aspectos legais, éticos, sociais e culturais da gestação de substituição comercial, bem como o panorama atual em todo o mundo. Métodos Trata-se de uma revisão da literatura publicada no século XXI sobre a gestação de substituição comercial. Resultados Um total de 248 artigos foi incluído nesta revisão. A demanda por tratamentos com gestação de substituição por mulheres sem útero ou com distúrbios uterinos importantes, homens solteiros e casais masculinos está aumentando constantemente em todo o mundo. Este tratamento reprodutivo tem dilemas éticos importantes. Além disso, a legislação é amplamente adiada em todo o mundo e está em constante mudança. Portanto, os pacientes procuram cada vez mais por tratamentos no exterior, o que pode levar a importantes problemas legais entre países com leis diferentes. A gestação de substituição comercial é praticada em vários países, na maioria dos quais não há legislação específica. Alguns países tomaram medidas restritivas contra esta técnica por causa de relatos de exploração destas mulheres. Conclusão A gestação de substituição comercial é uma prática comum, apesar de importantes dilemas éticos e legais. Como consequência de diversas legislações nacionais, os pacientes frequentemente recorrem a programas de gestação de substituição comercial internacionais. Atualmente, não existe um contexto jurídico internacional padrão e esta prática permanece em grande parte não regulamentada.

Trascendencia de los Comités de Ética de Investigación en Seres Humanos en el Ecuador / Research Ethics Committees of Human Beings in Ecuador

INTRODUCCIÓN. Los Comités de Ética de Investigación en Seres Humanos deben proteger la dignidad, los derechos, el bienestar y la seguridad de los sujetos investigados; evalúan aspectos éticos, metodológicos y jurídicos de los protocolos de investigación, competencia otorgada por el ente sanitario del país que ameritó observar si se cumplió. OBJETIVO. Evaluar la situación de los Comités de Ética de Investigación en Seres Humanos, basados en la percepción del cursillista, la normativa, las repercusiones y consecuencias para mantener su condición activa y su trascendencia. MATERIALES Y MÉTODOS. Estudio descriptivo, transversal y ambispectivo con un universo de 1 327 profesionales del área de la salud y una muestra de 385 encuestados que expresaron su percepción sobre trece Comités de Ética de Investigación en Seres Humanos a nivel nacional, con revisión bibliográfica nacional e internacional, se excluyeron los suspendidos. Se aplicó encuesta validada online, período abril a octubre de 2019. Data analizada en Excel y SPSS versión 23. RESULTADOS. El 76,92% Comités de Ética de Investigación en Seres Humanos fueron de la ciudad de Quito. Los cursillistas percibieron que el 64,16%, no trascendieron en su labor; desconocieron que: la Dirección Nacional de Inteligencia de la Salud, cuestionó el nombramiento de algún miembro un 97,14%; el cuestionamiento estuvo basado en la norma vigente un 79,48%; sobre la aprobación del plan anual de capacitación en investigación, 2019, un 95,06%; el plan anual de capacitación específico un 77,40%, y no recibieron directrices ni retroalimentación en temas de capacitación en calidad de investigador, un 90,39%. Además, percibieron que los Comités fueron responsables de capacitar otros Comités de ética de Investigación en Seres Humanos, un 81,82% y a los investigadores, un 85,71%; que deben elaborar el plan anual de educación específica para los miembros del comité, un 89,35%. CONCLUSIÓN. Se identificó entre los problemas que los investigadores casi no los conocen y hay necesidad de actualizar la norma que afectó el funcionamiento. Los justificativos para mantener la condición activa no se cumplieron, se evidenció la necesidad de asesoría para los comités por parte de las autoridades competentes, sin lograr conformación consolidada con actores y repercutió en su trascendencia.

INTRODUCTION. The Research Ethics Committees on Human Beings must protect the dignity, rights, well-being and safety of the research subjects; evaluate ethical, methodological and legal aspects of the research protocols, a competence granted by the health entity of the country that merited see if it is done. OBJECTIVE. Evaluate the situation of the Ethics Committees for Research in Human Beings, based on the perception of the trainee, the regulations, the repercussions and consequences to maintain their active condition and their transcendence. MATERIALS AND METHODS. Descriptive, cross-sectional and ambispective study with a universe of 1,327 professionals in the health area and a sample of 385 respondents who expressed their perception of thirteen Research Ethics Committees on Human Beings at the national level, with national and international bibliographic review. those suspended were excluded. An online validated survey was applied, from April to October 2019. Data analyzed in Excel and SPSS version 23. RESULTS. 76.92% Human Research Ethics Committees were from the city of Quito. The trainees perceived that 64,16%, did not transcend in their work; they did not know that: the National Directorate of Health Intelligence, questioned the appointment of a member 97,14%; the questioning was based on the current norm 79,48%; on the approval of the annual research training plan, 2019, 95,06%; the specific annual training plan 77,40%, and did not receive guidelines or feedback on training issues as a researcher, 90,39%. In addition, they perceived that the Committees were responsible for training other Human Beings Research Ethics Committees, 81,82% and the researchers, 85,71%; that they must prepare the annual specific education plan for the members of the committee, 89,35%. CONCLUSION. It was identified among the problems that the researchers hardly know them and there is a need to update the norm that affected the operation. The justifications to maintain the active condition were not fulfilled, the need for advice for the committees by the competent authorities was evidenced, without achieving a consolidated conformation with actors and had repercussions on its importance. hardly know them and there is a need to update the norm that affected the operation. The justifications to maintain the active condition were not fulfilled, the need for advice for the committees by the competent authorities was evidenced, without achieving a consolidated conformation with actors and had repercussions on its importance.

25 años de legislación biomédica en España / 25 years of biomedical legislation in Spain

Se recoge a continuación el texto de la intervención del Profesor ROMEO CASABONA con ocasión del Acto Conmemorativo “25 Años de Legislación Biomédica en España”, organizado por el Comité de Bioética de España y el G.I. Cátedra de Derecho y Genoma Humano, que se celebró el día 19 de mayo de 2022 en el Congreso de los Diputados, en Madrid. En el acto, que fue presencial y en streaming, intervinieron el Profesor ROMEO CASABONA, Director del G.I. Cátedra de Derecho y Genoma Humano, y Federico DE MONTALVO, Presidente del Comité de Bioética de España, además de otras autoridades y especialistas (Aitziber EMALDI CIRIÓN, Vicente BELLVER CAPELLA, Francisco GRACIA NAVARRO, Marcelo PALACIOS, Antonio ALARCÓ HERNÁNDEZ, Javier SÁNCHEZ CARO, Ricardo DE LORENZO Y MONTERO, Victoria CAMPS, Iñigo DE MIGUEL, Pilar NICOLÁS).(AU)

This paper includes the intervention of Professor ROMEO CASABONA on the occasion of the Commemorative Ceremony “25 Years of Biomedical Legislation in Spain”, organised by the Spanish Bioethics Committee and the Chair in Law and the Human Genome R.G., which was held on 19 May 2022 in the Congress of Deputies, in Madrid. Professor ROMEO CASABONA, Director of the Chair in Law and the Human Genome R.G. and Chair in Law and the Human Genome, and Federico DE MONTALVO, President of the Spanish Bioethics Committee, as well as other authorities and specialists (Aitziber EMALDI CIRIÓN, Vicente BELLVER CAPELLA, Francisco GRACIA NAVARRO, Marcelo PALACIOS, Antonio ALARCÓ HERNÁNDEZ, Javier SÁNCHEZ CARO, Ricardo DE LORENZO Y MONTERO, Victoria CAMPS, Iñigo DE MIGUEL, Pilar NICOLÁS).(AU)