Comparative analysis of balneotherapy in European public health systems: Spain, France, Italy, and Portugal.

Balneotherapy comprises the use of natural mineral waters for health and/or well-being purposes. When balneotherapy is offered by the public health system, some countries with Latin-based languages call it social thermalism. The aim of this study is to compare balneotherapy in health systems of Spain, France, Italy, and Portugal. The study involves a qualitative systematic review of the literature using the systematic search flow method. Twenty-two documents, from 2000 to 2022, were included and its findings were described in seven categories: the first outlines the historical characterization of social thermalism in the systems analyzed and the others outline the components of the health systems: coverage/access, health financing, workforce, inputs and techniques, organization and regulation, and network provision of services. The models of insurance and social security that cover part of the thermal treatment are highlighted. Doctors with competence in medical hydrology constitute the majority of the workforce. Similarities regarding inputs and techniques are observed, with variation in the number of days of the balneotherapy treatment cycle. In the regulation of services, the Ministry of Health of each country is prominent. The provision of services is mainly performed in specialized care in accredited balneotherapy establishments. Despite the limitations of the method, the comparisons made may serve to support public policies for balneotherapy.

Acesso a medicamentos para doenças raras no pós-estudo: revisão integrativa / Post-trial access to drugs for rare diseases: an integrative review / Acceso a medicamentos para enfermedades raras en el posestudio: una revisión integradora

Resumo A fim de analisar a produção científica acerca do acesso a medicamentos no pós-estudo por participantes de ensaios clínicos com doenças raras, realizou-se revisão integrativa da literatura nas bases Biblioteca Virtual em Saúde, Embase, PubMed, SciELO, Scopus e Web of Science, abrangendo 21 estudos. No processo analítico, surgiram duas categorias: pesquisa clínica com drogas órfãs e regulação do mercado; e acesso a drogas órfãs: história, globalização e direito à saúde. A primeira analisa questões relativas à quantidade de pacientes com doenças raras, à eficácia e à segurança dessas pesquisas e aos custos e preços dos medicamentos. A segunda trata do panorama histórico do acesso pós-estudo, da globalização dos ensaios clínicos e das dificuldades para efetivar o direito ao acesso a drogas órfãs no pós-estudo. Poucos artigos abordaram o acesso ao medicamento no pós-estudo por participantes com doenças raras como questão central, o que aponta a importância de mais estudos sobre esse tema.

Abstract This study is an integrative literature review to analyze the scientific production about post-trial drug access by participants of clinical trials for rare diseases. The search was carried out in the Virtual Health Library, Embase, PubMed, SciELO, Scopus and Web of Science databases, covering 21 studies. Two categories emerged from the analysis: clinical research with orphan drugs and market regulation; and access to orphan drugs: background, globalization and the right to health. The first analyzes issues related to the number of patients with rare diseases, the efficacy and safety of these studies and the cost and price of medications. The second addresses the historical background of post-trial access, the globalization of clinical trials and the difficulties to ensure the right to post-trial access to orphan drugs. Few articles addressed post-trial drug access by participants with rare diseases as a central issue, which points to the importance of further studies on this subject.

Resumen Se pretende analizar la producción científica sobre el acceso a medicamentos para enfermedades raras en el posestudio a partir de una revisión integradora en las bases de datos Biblioteca Virtual en Salud, Embase, PubMed, SciELO, Scopus y Web of Science, que encontraron 21 estudios. Surgieron dos categorías en el análisis: investigación clínica con medicamentos huérfanos y regulación del mercado; y acceso a medicamentos huérfanos: historia, globalización y derecho a la salud. La primera examina el número de pacientes con enfermedades raras, la eficacia y seguridad de los estudios, así como los costes y precios de los medicamentos. La segunda aborda el panorama histórico del acceso posestudio, la globalización de los ensayos clínicos y las dificultades para materializar el derecho al acceso a medicamentos huérfanos en el posestudio. Pocos estudios plantean el acceso a estos medicamentos en el posestudio, y son necesarios más estudios sobre el tema.

Desigualdad en el acceso a las vacunas: el fracaso de la respuesta mundial a la pandemia de COVID-19 / Inequity in access to vaccines: the failure of the global response to the COVID-19 pandemic

RESUMEN Este artículo resume las estrategias que se han utilizado para desarrollar rápidamente las vacunas COVID-19 y distribuirlas a nivel mundial. Se centra en las vacunas desarrolladas en los países occidentales. Con base en entrevistas y recopilación de información existente sobre la respuesta a la pandemia, tanto de agencias internacionales como de documentos oficiales de Brasil, Argentina, Colombia, Perú y México se reconoce que, si bien el desarrollo de las vacunas ha sido un éxito, su distribución a nivel mundial ha sido muy desigual. Como veremos, la pandemia consiguió movilizar una gran cantidad de recursos gubernamentales y los ciudadanos prestaron sus cuerpos para que los ensayos clínicos se pudieran concluir rápidamente. Sin embargo, las patentes impidieron la expansión de la capacidad de fabricación y los gobiernos de unos pocos países ricos priorizaron la protección y, en algunos casos, la sobreprotección de sus ciudadanos a expensas de la protección del resto de la población mundial. Entre los principales beneficiarios de la respuesta mundial a la pandemia se encuentran las principales empresas de vacunas, sus ejecutivos e inversores. El artículo concluye con algunas de las lecciones aprendidas en este proceso.

ABSTRACT This article summarizes the strategies used to rapidly develop COVID-19 vaccines and distribute them globally, with an emphasis on vaccines developed in western nations. It is based on interviews and information gathered regarding the response to the pandemic, both from international organizations and official documents from Brazil, Argentina, Colombia, Peru, and Mexico. While vaccine development has been hailed as successful, their global distribution has been highly unequal. We look at how the pandemic succeeded in mobilizing large quantities of government resources, and how citizens volunteered their bodies so that clinical trials could be completed quickly. However, patents prevented the expansion of manufacturing capacity, and the governments of a few wealthy countries prioritized the protection - and in some cases overprotection - of their citizens at the expense of protecting the rest of world's population. Among the major beneficiaries of the global response to the pandemic are the leading vaccine companies, their executives, and investors. The article concludes with some of the lessons learned in this process.

Access to health care as a human right in international policy: critical reflections and contemporary challenges. / El acceso a la salud como derecho humano en políticas internacionales: reflexiones críticas y desafíos contemporáneos.

Using the United Nations (UN) and its subordinate body, the World Health Organization (WHO), as a frame of reference, this article explores access to healthcare as a human right in international intergovernmental policies. First, we look at how the theme of health is treated within the UN, focusing on the concept of global health. We then discuss the concept of global health from a human rights perspective and go on to outline the debate surrounding universal coverage versus universal access as a human right, addressing some important ethical questions. Thereafter, we discuss universal coverage versus universal access using the critical and constructivist theories of international relations as a frame of reference. Finally, it is concluded that, faced with the persistence of huge global health inequalities, the WHO began to reshape itself, leaving behind the notion of health as a human right and imposing the challenge of reducing the wide gap that separates international intergovernmental laws from reality.

Access to health care as a human right in international policy: critical reflections and contemporary challenges

Using the United Nations (UN) and its subordinate body, the World Health Organization (WHO), as a frame of reference, this article explores access to healthcare as a human right in international intergovernmental policies. First, we look at how the theme of health is treated within the UN, focusing on the concept of global health. We then discuss the concept of global health from a human rights perspective and go on to outline the debate surrounding universal coverage versus universal access as a human right, addressing some important ethical questions. Thereafter, we discuss universal coverage versus universal access using the critical and constructivist theories of international relations as a frame of reference. Finally, it is concluded that, faced with the persistence of huge global health inequalities, the WHO began to reshape itself, leaving behind the notion of health as a human right and imposing the challenge of reducing the wide gap that separates international intergovernmental laws from reality.

[The use of placebos in phase III clinical trials in Brazil]. / El uso de placebo en ensayos clínicos de fase III en Brasil.

In 2008, Brazil's Federal Council of Medicine [Conselho Federal de Medicina] (CFM)--regulatory and supervisory agency on the ethical practice of medicine--banned the participation of Brazilian doctors in studies using placebos for diseases with efficient and effective treatment. This position differs with the Helsinki Declaration, which allows the use of placebos in methodologically justified conditions. To ascertain whether the CMF's ethical regulation modified the use of placebos in phase III clinical trials in Brazil, characteristics of the records in ClinicalTrials.gov were researched in the periods from 2003 to 2007 and from 2009 to 2013. The conclusions reached were: a) the regulations issued by the CFM in 2008 were ineffective and the position adopted by the Helsinki Declaration prevails; b) there was significant sponsorship by the multinational pharmaceutical industry of trials with placebos; c) the research was predominantly on new drugs for chronic diseases, with little study done of the neglected diseases which are of great importance to Brazil.

El uso de placebo en ensayos clínicos de fase III en Brasil / The use of placebos in phase III clinical trials in Brazil

El Consejo Federal de Medicina de Brasil (CFM) -órgano normativo y fiscalizador del ejercicio ético de la medicina- prohibió, en 2008, la participación de médicos brasileños en investigaciones que utilizaran placebo para enfermedades con tratamiento eficaz y efectivo, en contraposición a la Declaración de Helsinki, que permite su uso en condiciones metodológicamente justificadas. Con el objetivo de verificar si la normativa ética del CFM modificó el uso de placebo en ensayos clínicos de fase III en Brasil, se analizaron varias características de sus registros en el ClinicalTrials.gov, en los períodos de 2003 a 2007 y de 2009 a 2013. Se concluye que: a) la normativa promulgada por el CFM en 2008 fue ineficaz y prevaleció la posición adoptada por la Declaración de Helsinki; b) el patrocinio de ensayos con placebo por parte de la industria farmacéutica multinacional fue significativo; c) predominaron las investigaciones de fármacos para enfermedades crónicas, y fueron poco significativas para las enfermedades postergadas, de importancia para Brasil.

In 2008, Brazil's Federal Council of Medicine [Conselho Federal de Medicina] (CFM) - regulatory and supervisory agency on the ethical practice of medicine - banned the participation of Brazilian doctors in studies using placebos for diseases with efficient and effective treatment. This position differs with the Helsinki Declaration, which allows the use of placebos in methodologically justified conditions. To ascertain whether the CMF's ethical regulation modified the use of placebos in phase III clinical trials in Brazil, characteristics of the records in ClinicalTrials.gov were researched in the periods from 2003 to 2007 and from 2009 to 2013. The conclusions reached were: a) the regulations issued by the CFM in 2008 were ineffective and the position adopted by the Helsinki Declaration prevails; b) there was significant sponsorship by the multinational pharmaceutical industry of trials with placebos; c) the research was predominantly on new drugs for chronic diseases, with little study done of the neglected diseases which are of great importance to Brazil.

50th anniversary of the Declaration of Helsinki: the double standard was introduced.

The Declaration of Helsinki (DoH), adopted by the World Medical Association (WMA), is one of the most influential international documents in research ethics, is turning 50 in 2014. Its regular updates, seven versions (1975, 1983, 1989, 1996, 2000, 2008, 2013) and two notes of clarification (2002, 2004), characterize it as a 'live' document. The seventh version of the DoH was amended by the 64th WMA General Assembly, Fortaleza, Brazil, October 2013. The new version was reorganized and restructured, with paragraphs subdivided and regrouped. However, the DoH remains controversial and some ethical issues are still uncovered. The major problem was the insertion of the phrase 'less effective than the best proven' on placebo paragraph in order to allow double standard in medical research in low-resource countries. The DoH is a 'live' document, which will continually have to deal with new topics and challenges. Health equity needs to be a priority, and with that, a single ethical standard for medical research.