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.

Comentários ao Código de Processo Ético-Profissional dos Conselhos de Medicina: aprovado pela resolução CFM nº 2.306/2022 / Comments on the Code of Ethical-Professional Process of the Councils of Medicine: approved by CFM Resolution No. 2,306/2022

A Resolução nº 2.306 do Conselho Federal de Medicina (CFM), publicada no Diário Oficial da União (DOU), em 25 de março de 2022, aprovou o Código de Processo Ético-Profissional (CPEP/2022) dos Conselhos de Medicina, com vigência imediata em todo o território nacional. O novo CPEP, à luz da recente atualização do Decreto Federal nº 44.045/1958 pelo Decreto Federal nº 10.911/2021, dá segurança jurídica às atividades judicantes no âmbito dos conselhos de medicina. Diante dessa realidade, torna-se oportuna sua interpretação a partir da visão de especialistas no tema. Assim, esta obra, escrita pelo advogado Antônio Carlos Nunes de Oliveira, oferece pertinentes orientações em torno das novas questões processuais contidas no atual CPEP, com ampla citação jurisprudencial e doutrinária. Assim, estamos diante de um volume construído com esmero técnico, legal e ético. Por meio desta publicação, o CFM ­ com a colaboração de seu autor ­ disponibiliza aos médicos e advogados, bem como aos demais operadores do direito médico, argumentos que procuram desmistificar teorias, princípios e regras procedimentais a serem observadas em sindicâncias e processos éticos-profissionais, possibilitando uma melhor compreensão das atividades judicantes no âmbito dos conselhos de medicina. Desse modo, trata-se de contribuição relevante à defesa do exercício ético da medicina no país, sendo recomendada sua leitura com o objetivo de fortalecer o conhecimento jurídico e processual que a esfera judicante demanda.

Aspectos médico-legais do olho / Medicolegal aspects of the eye

RESUMO A oftalmologia fornece um campo vasto de conhecimentos necessários à medicina legal e às perícias médicas. O presente artigo objetivou revisar as informações na perícia criminal e cível, as repercussões da morte e os achados post-mortem que o exame ocular pode fornecer. Demonstrou-se que a perícia ocular é complexa e multifacetada, fornecendo ferramentas importantes para a classificação das lesões corporais, verificação da capacidade laboral, investigação da causa mortis e estimativa do tempo de morte.

ABSTRACT Ophthalmology provides a vast field of knowledge necessary for forensic medicine and medical expertise. The present article aimed to review the information on criminal and civil medical expertise, the repercussions of death, and the postmortem findings that the eye examination can provide. Ocular expertise has been shown to be complex and multifaceted, providing important tools to classify bodily injuries, verify work capacity, investigate the cause of death, and estimate the time of death.

Prevención del estrés y burn-out del equipo de salud: el nexo con la calidad de la atención sanitaria y la seguridad del paciente / Preventing stress and burn-out of healthcare staff: linkage with quality of healthcare systems and patient safety

Se destaca la importancia de la prevención del estrés y burn-out en los trabajadores que integran el equipo de salud. Se señala su directa relación con el error médico, la seguridad del paciente y la calidad de la atención sanitaria. (AU)

The purpose of this work is to point out the importance of preventing stress and burn-out of the healthcare staff and its relationship with medical errors, patient safety and quality of the healthcare systems. (AU)

The Key Elements of Medical Negligence-Duty.

American tort law (a.k.a. negligence) is designed to be flexible and elastic to adapt to changes in time and public policy. It provides a structure of elements and factors to be applied to each case's specific facts on a case-by-case basis. The purpose of this structure is to achieve as much uniformity as possible in the application of tort law. One side effect is that this structure makes predicting the outcome difficult because of so many variables. In addition, there is no national tort law. Instead, each state has developed its own law in the area of torts, which has resulted in differing exceptions and requirements based on where the medical care was given. The purpose of this article is to explain the first element of a negligence case-"duty to use care"-and its accompanying factors/variables. The first element that must be established in a medical negligence case is a duty to use care. In short, this means the physician must use a certain level of care in providing medical services. The physician typically owes her or his patient the duty to exercise care. However, there are special situations in which a physician may not owe a duty of care and thus cannot be held liable for medical negligence. This article is designed to provide an overview of the most common situations and summarizes the processes to determine whether a duty is owed.

Ley nacional del cáncer Claudio Mora: metas y desafíos a futuro / Claudio Mora National Cancer Law: Goals and challenges for the future

Actualmente el cáncer es la segunda causa de muerte en la población chilena; sin embargo, en algunas regiones del país como Arica y Parinacota, Antofagasta, La Serena, Los Lagos y Aysén, en Atacama y La Araucanía ya es la primera (1), inmediatamente apenas por debajo de las afecciones al sistema circulatorio y cardiovascular, y se espera que, al final de la próxima década, llegue a ser la primera causa de muerte en el país (2). Por otra parte, con respecto a los años de vida perdidos en Chile, el cáncer es la primera causa de años de vida perdidos por muerte prematura (175.741 años equivalentes al 22,5% del total de años). Si a lo anterior sumamos los años de vida perdidos por discapacidad, el cáncer es responsable de 221.529 AVISA (Años de vida ajustados por discapacidad), ubicándolo en el séptimo lugar de grupos de causas de carga de enfermedad.(3) Por su incidencia, el cáncer se ha constituido en un problema de salud pública indiscutible e insoslayable, por cuya gravedad demanda al sistema de salud chileno la máxima atención y el mejor de los esfuerzos en las tareas de las pesquisas temprana en toda la población, con el fin de minimizarsusefectos combinados enlasociedad demanera transversal y en cualquier contexto en el que ocurra, debido a la dificultad que significa para el sistema de salud chileno su pesquisa temprana en todos los ciudadanos, sumado a la escasez de recursos tanto humanos como materiales, por lo costos involucrados en su abordaje, es un importante problema social y económico, con repercusión y costos que afectan a laspersonas, sus familiasy comunidades, así como al sistema de salud y al país en su conjunto. (2) A la fecha, en Chile, grandes esfuerzos se han hecho para reducir estas brechas. El mayor de ellos es el programa GES (Garantías explícitas enSalud), mediante el cual los pacientes de acuerdo a su diagnóstico e independientemente de su capacidad de pago o seguro de salud asociado, región geográfica o nivel educacional, son asegurados con una canasta de prestaciones estandarizada, con tiempos de atención antes definidos, asegurando así acceso, oportunidad, protección financiera y calidad delprestador. (4) No obstante luego de 15 años de iniciado elprograma de prestaciones GES, persisten estas diferencias tanto por nivel socioeconómico, y/o educacional, queinfluyen negativamente sobre los estándares de atención de los diferentes prestadores de salud, en razón que diversos estudios se han observado diferencias estadisticamente significativas en las tasas de mortalidad entre el sistema público y privado de 3,12 a 5,8 veces más mortalidad en los pacientes atendidos por FONASA (Fondo nacional de Salud) , respecto a los prestadores privados provenientes de ISAPRES (Instituciones de salud previsional). (5) La ley Nacional del Cáncer recibe el nombre del doctor Claudio Mora a modo de homenaje póstumo, pues él encarnó la dualidad de paciente oncológico y profesional al ser tratado por un cáncer de páncreas, junto al Dr. Jorge Jiménez de la Jara, y la senadora Carolina Goic, quienes fueron grandes impulsores de esta ley, que cuenta con $80 mil millones de pesos anuales ($20 mil millones para infraestructura y $60 mil millones para tratamientos que hoy no son cubiertos por el GES ni por la Ley Ricarte Soto), además de $200 millones anuales por ocho años para la construcción de la Red Nacional Oncológica.(6) La ley nacional del cáncer es un proyecto a largo plazo que requiere de una red oncológica integrada de profesionales y de la coordinación de un equipo interdisciplinario que presenta deficiencias tanto en el número como en la especializaciónde sus equipos médicos. En el presente contexto de la pandemia por coronavirus iniciada en Chile el 1 de marzo de 2020, contrapuesto a lo anterior la disminución de los diagnósticos de cáncer es un hecho, como consecuencia directa de la priorización de camas crítica como camas básicas y de intermedio para atender pacientes infectados por coronavirus, a pesar de lo anterior ha entrado en vigencia la Ley Nacional de Cáncer, es decir, la nueva Ley 21.258, que pretende asegurar que se proporcione un óptimo diagnóstico, tratamiento y seguimiento a los pacientes. (7)

La COVID-19 como enfermedad profesional: breve análisis de la ley 19873 / COVID-19 as an occupational disease: brief analysis of law 19,873

El artículo se ocupa de analizar la COVID-19 como enfermedad profesional, partiendo de un estudio del concepto de esta última a la luz de nuestro ordenamiento jurídico. Se plantean las posibilidades de considerar esta nueva enfermedad como profesional, no incluida en la lista actualmente vigente sobre las mismas. Luego de analizar la posibilidad de extender el régimen de las enfermedades profesionales contenido en la ley 16.074, el estudio analiza la regulación de la ley 19.873, la que es calificada como restrictiva de la consideración de la COVID-19 como enfermedad. Se contextualiza la legislación nacional en el derecho comprado, donde pueden encontrarse diversas "respuestas" a las consecuencias laborales de la enfermedad.

LifeTime and improving European healthcare through cell-based interceptive medicine.

Here we describe the LifeTime Initiative, which aims to track, understand and target human cells during the onset and progression of complex diseases, and to analyse their response to therapy at single-cell resolution. This mission will be implemented through the development, integration and application of single-cell multi-omics and imaging, artificial intelligence and patient-derived experimental disease models during the progression from health to disease. The analysis of large molecular and clinical datasets will identify molecular mechanisms, create predictive computational models of disease progression, and reveal new drug targets and therapies. The timely detection and interception of disease embedded in an ethical and patient-centred vision will be achieved through interactions across academia, hospitals, patient associations, health data management systems and industry. The application of this strategy to key medical challenges in cancer, neurological and neuropsychiatric disorders, and infectious, chronic inflammatory and cardiovascular diseases at the single-cell level will usher in cell-based interceptive medicine in Europe over the next decade.

Impact of malpractice liability among spine surgeons: A national survey of French private neurosurgeons.

PURPOSE: In the general context of medical judicialization, spine surgeons are impacted by the part that medical responsibility and the risk of malpractice play in their actions and decisions. Our aim was to evaluate possible shifts in practices among private neurosurgeons who are highly exposed to this judicial risk and detect alterations in their pleasure in exercising their profession. We present the first national survey on French physicians' perception of surgical judicialization and consequences on their practice. METHODS: An online survey was submitted to the 121 members of the French Society of Private Neurosurgery, who represent 29.1% of the total number of spine surgeons and perform 36.0% of the national total spine surgery activity. The French law (no-fault out-of-court scheme) significantly impacts these surgeons in the event of litigation. RESULTS: A total of 78 surveys were completed (64.5% response rate): 89.7% of respondents experienced alteration of doctor-patient relationship related to judicialization and 60.2% had already refused to perform risky surgeries. Fear of being sued added negative pressure during surgery for 55.1% of respondents and 37.2% of them had already considered stopping their practice because of this litigation context. CONCLUSION: The increasing impact of medical liability is prompting practitioners to change their practice and perceptions. The doctor-patient relationship appears to be altered, negative pressure is placed on physicians and defensively, some neurosurgeons may refuse high-risk patients and procedures. This situation causes professional disenchantment and can ultimately prove disadvantageous for both doctors and patients.

Advocacy and the Hand Surgeon: Why and How.

This article explains and gives examples of the importance of political advocacy for hand surgeons at the federal and state levels. Two health care leaders who are also hand surgeons, one now serving as a state Senator and one a former President of the American Medical Association, give their perspective on participation in the political process. The article covers avenues for advocacy for hand surgeons as individuals and as members of medical organizations, including suggestions about effective communication with legislators. There is discussion of the unique role of the American Society for Surgery of the Hand in representing hand surgeons.

La educación médica continua y la vigencia de la especialidad médica / Continuous medical education and the validity of medical specialty

La educación médica continua (EMC) es el proceso de adquisición de nuevos conocimientos y habilidades a lo largo de toda la vida activa de los médicos. Es responsabilidad de cada médico para poder ofrecer la mejor atención a sus enfermos. La EMC no se limita a la educación formal, sino que dispone de distintas estrategias de aprendizaje, entre las que se mencionan los cursos y ateneos, la concurrencia a congresos, jornadas y simposios, el entrenamiento en servicio, la educación a distancia y el autoaprendizaje. La EMC debe ser considerada como la etapa final y más larga en la formación de un médico. (AU)

Continuing medical education (CME) is the process of acquiring new knowledge and skills throughout active life of doctors. It is the responsibility of each doctor to be able to offer the best care of their patients. The CME is not limited to formal education, but different learning are available, including courses, athenaeums, congress attendance, conferences and symposia, in-service training, distance education and self-learning. The CME should be considered as the final and longest stage in the doctor´s training. (AU)

Guidance on Prescription of Homeopathic Treatments: Ramifications of a Failed Administrative Law Challenge.

In R (on the application of British Homeopathic Association) v National Health Service Commissioning Board [2018] EWHC 1359 (Admin) Supperstone J of the High Court of England and Wales delivered an internationally significant judgment on the processes required to be engaged in when guidance is given to medical practitioners about their involvement in homeopathic prescribing. This column explores the bases upon which the challenge by the British Homeopathic Association was lost and the repercussions of the judgment for the practice of non-evidence-based modalities, such as homeopathy.

[Medical Methods: What Makes them Medically Necessary? Part II: Further Criteria, Overuse, Moving Thresholds, and Grey Zones]. / Medizinische Behandlungsmethoden: Was macht sie medizinisch notwendig? Teil II: Weitere Kriterien, Übermaßverbot, wandernde Grenzen und Grauzonen.

OBJECTIVES: "Medical necessity" (MedN) is a fuzzy term. Our project aims at concretising the concept between medical ethics, social law, and social medicine to support health care regulation, primarily within Germany's statutory health insurance system. In Part I, we identified efficacy, (net)benefit, and the corresponding bodies of evidence as obligatory criteria of MedN. This is the second part suggesting and discussing further criteria. METHODS: See Part I RESULTS: (Part II): As further MedN-criteria we critically assessed a method's effectiveness and acceptance in routine care, its potential beneficiaries, theoretical fundament, cost, and being without alternative as well as patients' self-responsibility, cooperation, and preferences. Since MedN has both lower and upper bounds, we had to consider certain cases of mis- and overuse, due for instance to "indication creep" or "disease mongering". CONCLUSIONS: The additional criteria neither establish MedN (when met singly or together) nor exclude it (when not met). If MedN is rejected in view of the 3 obligatory criteria then further information does not overturn the verdict. If a method is already assessed as being medn then further criteria do not make it "more or less necessary". Though we advocated for a binary MedN-concept (Part I) we are nonetheless convinced that not all medical methods deemed medn are equally medically relevant. Respective differences within the range of MedN could be assessed by techniques to prioritise medical conditions, methods, and aims.

Prevención de estrés y Burn-Out en el equipo de salud / Stress prevention and Burn-Out in health team

El objetivo de este trabajo es difundir la Ley Nº 2578 de la Ciudad Autónoma de Buenos Aires (CABA) del 06/12/07, promulgada por decreto N° 09/008 del 07/01/08, publicada en BOCBA N° 2.850 del 15/01/08, relativa a la creación del "Programa de Prevención, Detección Precoz y Rehabilitación del Estrés Laboral Crónico de los Trabajadores de la Salud". También hacer algunas consideraciones sobre esta enfermedad y destacar al síndrome de Burn-Out como resultado de un estrés laboral crónico que se desarrolla en los ambientes laborales del equipo de la salud

The purpose of this work is to spread Law C.A.B.A. N° 2.578 regarding the creation of the Program for the Prevention, Early Detection and Rehabilitation of Chronic Labor Stress of Health Care Workers of Autonomous City of Buenos Aires. Also make some considerations about this disease and highlight Burn Out syndrome as result of chronic work stress that develops in the work environment of the health team.