Autoridades reguladoras de medicamentos sul-americanas: uma análise a partir de regras organizacionais / Drug regulatory authorities in South America: an analysis based on organizational rules

OBJETIVO: Descrever a organização das autoridades reguladoras nacionais (ARN) de medicamentos da Argentina, Brasil, Chile e Peru pela análise de categorias representativas de regras organizacionais. MÉTODOS: As ARN estudadas foram selecionadas utilizando-se os seguintes critérios: estar em país da América do Sul, ter sido identificada como ARN nos Encuentros de Autoridades Competentes en Medicamentos de los Países Iberoamericanos e apresentar boa disponibilidade de dados eletrônicos sobre estrutura e processo da regulação de medicamentos. Como principal fonte de dados, foram consultadas páginas eletrônicas entre maio de 2010 e março de 2011. As categorias analíticas foram: estrutura da organização, competências, direcionalidade e formas de responsabilidade e prestação de contas. RESULTADOS: As ARN da Argentina e do Brasil funcionavam como agências autônomas, enquanto que as do Chile e do Peru se subordinavam diretamente aos respectivos ministérios da saúde. À exceção da ARN brasileira, evidenciou-se a dependência das demais em relação ao ministério para emitir normas sanitárias. O escopo de ação de cada autoridade se diferenciou pelos bens e serviços a ela sujeitos, sendo a do Peru a única dedicada exclusivamente à regulação de medicamentos. As quatro ARN realizam todos os processos apontadas pela Organização Mundial da Saúde como essenciais para uma regulação efetiva. CONCLUSÕES: Os resultados apontam para um esforço dos países estudados em melhorar sua estrutura regulatória. Não obstante, em diversos aspectos, as quatro ARN ainda precisam aprimorar mecanismos para garantir, ao final da cadeia regulatória, a qualidade e a segurança dos medicamentos por elas regulados, com mais transparência nos processos decisórios e prestação de contas à sociedade.

OBJECTIVE: To describe the organization of national drug regulatory authorities (DRAs) in Argentina, Brazil, Chile, and Peru through the analysis of categories representing organizational rules. METHODS: The DRAs were selected using the following criteria: being in a South American country, having been identified as DRAs at Encuentros de Autoridades Competentes en Medicamentos de los Países Iberoamericanos (Conferences of Ibero-American Drug Regulatory Authorities), and having good availability of electronic data regarding organizational structure and the process of drug regulation. The main source of data were websites, which were reviewed between May 2010 and March 2011. The analytical categories were: organizational structure, competencies, directionality (mission and vision statements), and forms of accountability. RESULTS: The DRAs of Argentina and Brazil functioned as autonomous agencies, while those of Chile and Peru were directly subordinated to the ministries of health. Except for the Brazilian DRA, the agencies in the other three countries were dependent on their health ministries to issue sanitary regulations. The scope of action of each DRA differed in terms of the goods and services covered, with the Peruvian DRA being the only one exclusively dedicated to the regulation of drugs. The four DRAs performed all the processes identified by the World Health Organization as essential for effective drug regulation. CONCLUSIONS: The results show an effort by the studied countries to improve their regulatory structure. Nevertheless, all four DRAs need to improve some mechanisms to ensure that, at the end of the regulatory chain, the drugs they regulate have the desired quality and safety, with more transparency in decision-making processes and social accountability.

Toward greater inclusion: lessons from Peru in confronting challenges of multi-sector

Despite widespread enthusiasm for broader participation inhealth policy and programming, little is known about theways in which multi-sector groups address the challengesthat arise in pursuing this goal. Based on the experience ofPeru’s National Multi-sector Health Coordinating Body(CONAMUSA), this article characterizes these challengesand identifies organizational strategies the group has adoptedto overcome them. Comprising nine government ministries,nongovernmental organizations, academia, religious institutions,and international cooperation agencies, CONAMUSAhas faced three principal challenges: 1) selecting representatives,2) balancing membership and leadership across sectors,and 3) negotiating role transition and conflict. In response,the group has instituted a rotation system for formal leadershipresponsibiliti es, and professionalized management functions;created electoral systems for civil society; and developedconflict of interest guidelines. This case study offers lessonsfor other countries trying to configure multi-sector groups,and for donors who mandate their creation, tempering unbridledidealism toward inclusive participation with a dose ofhealthy realism and practical adaptation.

A pesar del entusiasmo generalizado por la mayor participaciónen las políticas y programas sanitarios, poco sesabe sobre las formas de afrontar los retos que se planteanen la consecución de este objetivo por parte de los gruposmultisectoriales. Este artículo parte de la experiencia de laCoordinadora Nacional Multisectorial en Salud del Perú(CONAMUSA) para caracterizar dichos retos e identificarlas estrategias de organización que ha adoptado el grupo afin de superarlos. CONAMUSA, formada por nueve ministeriosdel gobierno, organizaciones no gubernamentales, institucionesacadémicas, organizaciones religiosas y agenciasde cooperación internacional, se ha enfrentado con tres retosfundamentales: 1) elegir a los representantes, 2) encontrarel equilibrio entre la representación de los miembros y elliderazgoen los distintos sectores y 3) negociar el cambio deroles y los conflictos. Para responder a estos retos el grupoha establecido un sistema rotatorio para las responsabilidadesformales de liderazgo y ha profesionalizado las funcionesde gestión, se han creado sistemas electorales para lasociedad civil y se han elaborado pautas para los conflictosde intereses. Este estudio de casos aporta lecciones para otrospaíses que estén tratando de configurar grupos multisectoriales,así como para los organismos de ayuda que dirigen sucreación, suavizando los idealismos extremos con una dosisde realismo saludable y de adaptación práctica para lograruna participación inclusiva.

La última reforma del sistema general de seguridad social en salud Colombiano / The latest reform of the Colombian healthcare-related social security system

Objetivo El propósito de este ensayo es explorar y analizar los cambios y oportunidades generados con la reforma del sistema de salud colombiano, a partir de la ley 1438 del 2011. Métodos Para lograrlo se revisan documentalmente algunos temas pendientes desde la reforma introducida por la ley 100 de 1993 y los compara con la norma del 2011; también se contrastan con algunas estrategias de la salud pública inoperantes en la etapa de la reforma, bajo condiciones del modelo de mercado. Resultados Se discute esta segunda fase de la reforma en relación con el alcance del derecho a la salud, el acceso y la equidad global. Se reconoce el avance en temas importantes, como la igualación de los paquetes de beneficios, la atención primaria en salud, las redes integradas de servicios de salud, pero se discute su inoperancia para modificar aspectos medulares del sistema, como la sostenibilidad financiera y la lógica económica que se imponen sobre las estrategias mencionadas las cuales ven cercenada su capacidad de respuesta, en aras de mantener incólume el modelo de la ley 100 de 1993. Conclusión Finalmente, se esbozan los puntos cruciales necesarios a una gran reforma estructural del sistema de salud colombiano que se base en el derecho a la salud y en la equidad.

Objective This essay was aimed at exploring and analysing the challenges and opportunities arising from reforming Colombian law 1438/2011 dealing with the healthcare-related social security system. Methods Some outstanding issues from the reform introduced by Law 100/1993 were reviewed and then compared to the 2011 regulations; they were also contrasted (in market model conditions) with some public health strategies which were inoperative during the reform stage. Results This second reform phase was discussed in relation to the scope of the right to health, access and overall equity. Progress regarding important issues such as benefit package equalisation, primary healthcare attention, integrated healthcare service networks was recognised; however, its failure to change core aspects of the system was discussed, i.e. financial sustainability and the economic rationale imposed on the aforementioned strategies which curtailed its responsiveness to keep the model introduced by law 100/1993 intact. Conclusion The crucial points necessary for major structural reform of the Colombian healthcare system based on the right to health and equity were then outlined.

Evaluation of Brazil's public health surveillance system within the context of the International Health Regulations (2005) / Evaluación del sistema de vigilancia de salud pública del Brasil dentro del contexto del Reglamento Sanitario Internacional (2005)

OBJECTIVE: To evaluate Brazil's public health surveillance system (HSS), identifying its core capacities, shortcomings, and limitations in dealing with public health emergencies, within the context of the International Health Regulations (IHR 2005). METHODS: In 2008-2009 an evaluative cross-sectional study was conducted using semistructured questionnaires administered to key informants (municipal, state, and national government officials) to assess Brazilian HSS structure (legal framework and resources) and surveillance and response procedures vis-à-vis compliance with the IHR (2005) requirements for management of public health emergencies of national and international concern. Evaluation criteria included the capacity to detect, assess, notify, investigate, intervene, and communicate. Responses were analyzed separately by level of government (municipal health departments, state health departments, and national Ministry of Health). RESULTS: Overall, at all three levels of government, Brazil's HSS has a well-established legal framework (including the essential technical regulations) and the infrastructure, supplies, materials, and mechanisms required for liaison and coordination. However, there are still some weaknesses at the state level, especially in land border areas and small towns. Professionals in the field need to be more familiar with the IHR 2005 Annex 2 decision tool (designed to increase sensitivity and consistency in the notification process). At the state and municipal level, the capacity to detect, assess, and notify is better than the capacity to investigate, intervene, and communicate. Surveillance activities are conducted 24 hours a day, 7 days a week in 40.7% of states and 35.5% of municipalities. There are shortcomings in organizational activities and methods, and in the process of hiring and training personnel. CONCLUSIONS: In general, the core capacities of Brazil's HSS are well established and fulfill most of the requisites listed in the IHR 2005 with respect to both structure and surveillance and response procedures, particularly at the national and state levels.

OBJETIVO: Evaluar el sistema de vigilancia de salud pública del Brasil, identificando sus capacidades básicas, deficiencias y limitaciones para manejar emergencias de salud pública, dentro del contexto del Reglamento Sanitario Internacional (RSI 2005). MÉTODOS: En el período 2008-2009 se llevó a cabo un estudio transversal de evaluación utilizando cuestionarios semiestructurados administrados a informantes clave (funcionarios del gobierno municipal, estatal y nacional) a fin de evaluar la estructura del sistema de vigilancia de salud pública del Brasil (marco jurídico y recursos), y la vigilancia y los procedimientos de respuesta, con relación al cumplimiento de los requisitos del RSI 2005 para el manejo de emergencias de salud pública de importancia nacional e internacional. Los criterios de evaluación incluyeron la capacidad de detectar, evaluar, notificar, investigar, intervenir y comunicar. Las respuestas se analizaron por separado según el nivel gubernamental (departamentos de salud municipales y estatales y ministerio de salud nacional). RESULTADOS: En general, en los tres niveles del gobierno, el sistema de vigilancia de salud pública del Brasil tiene un marco jurídico bien establecido (incluidas las reglamentaciones técnicas esenciales) y la infraestructura, los suministros los materiales y los mecanismos requeridos para el enlace y la coordinación. Sin embargo, todavía hay algunos puntos débiles a nivel estatal, especialmente en las zonas fronterizas y los pueblos pequeños. Los profesionales de campo deben conocer más la herramienta de decisión del anexo 2 del RSI 2005 (diseñada para aumentar la sensibilidad y la consistencia del proceso de notificación). En el nivel estatal y municipal, la capacidad para detectar, evaluar y notificar es mejor que la capacidad para investigar, intervenir y comunicar. Las actividades de vigilancia se llevan a cabo 24 horas al día, 7 días a la semana, en 40,7% de los estados y 35,5% de los municipios. Existen deficiencias en las actividades de organización y los métodos, y en el proceso de contratación y capacitación del personal. CONCLUSIONES: En general, las capacidades básicas del sistema de vigilancia de salud pública del Brasil están bien establecidas y cumplen la mayoría de los requisitos enumerados en el RSI 2005, tanto con respecto a la estructura como a la vigilancia y los procedimientos de respuesta, en particular en los niveles nacional y estatal.

Situación del sistema de vigilancia de casos de Dengue en un municipio de Colombia / The status of the dengue surveillance system in a Colombian municipality

Objetivos La vigilancia del dengue es fundamental para definir, implementar y evaluar las intervenciones y para la detección precoz de epidemias. Las direcciones municipales de salud son el nodo que garantiza la calidad y cobertura del sistema y los usuarios inmediatos de la información. El objetivo del presente estudio fue evaluar el sistema de vigilancia de dengue en una dirección municipal de salud en el Valle del Cauca en el año 2008. Métodos Se siguió el modelo del CDC con énfasis en 1) la descripción del sistema, 2) los recursos disponibles, 3) el cumplimiento en la notificación y ajuste de casos y 4) el uso de la información. Se realizaron entrevistas a funcionarios y revisión de los datos de dengue de la Secretaria Departamental y Municipal de Salud y del Laboratorio Departamental de Salud Pública. Resultados La cobertura de notificación fue del 91,3 %, se evidenciaron falta de uso del sistema electrónico y retraso en el envío de los datos. Tres personas estaban a cargo de todas las funciones de salud pública pero no tenían formación en sus respectivas áreas ni conocimiento de los protocolos. No se realizaba análisis sistemático de los datos. Conclusiones Como en otros municipios de Colombia, la falta de capacitación y perfil de los funcionarios y de otros recursos, y el alto recambio de personal son los aspectos básicos más débiles del sistema de vigilancia en salud pública del municipio. Se han implementado correctivos tendientes a mejorar el sistema de vigilancia en el municipio.

Objective The surveillance of dengue cases is essential for defining, implementing and assessing interventions and promptly detecting outbreaks. Municipal health authorities are the key stakeholders guaranteeing surveillance system quality and coverage and are the first users of the information so collected. The present study was aimed at assessing how well the dengue case surveillance system was operating in a municipality in the Valle del Cauca department of Colombia during 2008. Methods The CDC proposed model was used. Emphasis was placed on describing system operation, the available resources, compliance with reports and case adjustment and using information. Interviews were held with health workers. Dengue surveillance system data from the municipality, departmental health authorities and the Valle del Cauca Public Health Laboratory were reviewed. Results Notification coverage was 91.3 %. A lack of using surveillance software and delays in notification were identified. Three people were in charge of all public health responsibilities and none of them had had any training or prior knowledge regarding public health surveillance protocols. There had not been any systematic data analysis. Conclusions As in other areas of Colombia, the lack of training, professional profile and other resources as well as a high turnover of public health personnel were the weakest points of the surveillance system in the municipality. Corrective measures for improving the surveillance system have now been implemented in the municipality which was studied.

Financiamiento público de la investigación en salud en cinco países de América Latina / Public financing of health research in five Latin American countries

OBJETIVOS: Describir los subsistemas públicos de los Sistemas Nacionales de Investigación en Salud (SNIS) en cinco países de América Latina (Argentina, Bolivia, Chile, Paraguay y Uruguay), con énfasis en los tipos de arreglos institucionales que se observan en cada país para promover, desarrollar y sostener sus SNIS, así como en los mecanismos explícitos o implícitos de priorización de proyectos de investigación en salud. MÉTODOS: Se identificó a los organismos responsables de manejar los recursos públicos destinados a financiar proyectos de investigación en salud en los cinco países estudiados. Luego se analizaron los tipos de proyectos que fueron financiados -utilizando una matriz por área y objeto de estudio-, ciertas características de los investigadores principales y los montos asignados entre 2002 y 2006. RESULTADOS: Solamente los países con mayores recursos o con redes de investigadores más desarrolladas poseen estructuras formales de asignación de fondos, con convocatorias periódicas y reglas estables, y ninguno cuenta con mecanismos explícitos e integrales de priorización para la investigación en salud. A su vez, las prioridades de investigación en salud presentan diferencias importantes entre países. En este sentido, es notorio que ciertos problemas, como "nutrición y medio ambiente" o "violencia y accidentes", reciban escasa atención en la mayoría de los países, al igual que varios temas de salud pública en algunos otros. Contrariamente, la investigación referida a "ciencias básicas" absorbe hasta un tercio de los recursos totales para investigación. CONCLUSIONES: Surgen numerosos interrogantes acerca de la capacidad de estos países para adaptar y generar nuevos conocimientos, y de la casi inexistente investigación sobre condicionantes sociales, económicos y culturales o sobre servicios y sistemas de salud, de alto impacto en grupos con acceso limitado al cuidado de la salud. Es necesario establecer explícitamente las prioridades en la agenda de investigación en salud, en consenso con las partes interesadas, así como incorporar mecanismos de monitoreo y seguimiento por temas y áreas de estudio del financiamiento de la investigación en este campo.

OBJECTIVES: Describe the public subsystems of the national health research systems (SNIS) in five Latin American countries (Argentina, Bolivia, Chile, Paraguay, and Uruguay), emphasizing the types of institutional arrangements in place in each country to promote, develop, and sustain their SNIS, as well as explicit or implicit mechanisms for prioritizing health research projects. METHODS: The bodies responsible for managing the public resources allocated to finance health research projects in the five countries studied were identified. The types of projects financed were then analyzed-using a matrix constructed by area and object of study-, certain characteristics of the principal investigators, and the sums allocated between 2002 and 2006. RESULTS: Only the countries with greater resources or better developed networks of investigators have formal structures for allocating funds with regular calls for proposals and fixed rules. None of them has explicit comprehensive mechanisms for prioritizing health research. Moreover, the health research priorities in the countries vary widely. In this regard, it is significant that problems such as "nutrition and the environment" or "violence and accidents" receive little attention in most countries. The same holds true for a number of public health issues in some countries. In contrast, the research in the "hard sciences" absorbs up to one-third of the total resources for research. CONCLUSIONS: Many questions arise about the ability of these countries to adapt and generate new knowledge, as well as the nearly nonexistent research on social, economic, and cultural determinants, or on health services and systems that have a high impact on groups with limited access to health care. Explicit priorities should be set with stakeholders for the health research agenda, and mechanisms should be adopted for monitoring and following up health research financing by subject and area of study.

Los institutos nacionales de salud pública: un enfoque coordinado e integral contra la influenza A H1N1 y otras amenazas a la salud pública / National public health institutes: a coordinated and comprehensive approach toward influenza A H1N1 and other threats to public health

The current influenza A H1N1 epidemic has demonstrated once again the importance of being able to count on robust, coordinated, and comprehensive public health systems. Countries that do rely on such health systems have proven to recognize, diagnose, and treat influenza in a timely manner, and to provide the public with the education needed to minimize the number of deaths and acute cases. The International Association of National Public Health Institutes (IANPHI) recommends that all countries begin to coordinate their national public health efforts. IANPHI offers its support and guidance to all who would create or strengthen their national public health institutes. By strengthening national public health systems, the ability to collaborate and the security of all countries is heightened. These institutions exist for the public good, and any improvements made to them are also a contribution toward better health for the population.

The structural molecular biology network of the State of São Paulo, Brazil

Esse artigo descreve realizações do Programa SMolBNet (Rede de Biologia Molecular Estrutural) do Estado de São Paulo, apoiado pela FAPESP (Fundação de Apoio à Pesquisa do Estado de São Paulo). Ele reúne vinte grupos de pesquisa e é coordenado pelos pesquisadores do Laboratório Nacional de Luz Síncrotron (LNLS), em Campinas. O Programa SMolBNet tem como metas: Elucidar a estrutura tridimensional de proteínas de interesse aos grupos de pesquisa componentes do Programa; Prover os grupos com treinamento em todas as etapas de determinação de estrutura: clonagem gênica, expressão de proteínas, purificação de proteínas, cristalização de proteínas e elucidação de suas estruturas. Tendo começado em 2001, o Programa alcançou sucesso em ambas as metas. Neste artigo, quatro dos grupos descrevem suas participações, e discutem aspectos estruturais das proteínas que eles selecionaram para estudos.

Organizações sociais e instituições governamentais: perspectivas de parceria na atenção à saúde da criança através dos voluntários e da pastoral da criança / Social organizations and governmental institutions: perspectives on partnerships in children's health care through volunteers and the pastoral da criança

Este estudo objetiva apresentar algumas perspectivas de parceria entre organizações sociais e instituições governamentais na atenção à saúde da criança.Trata-se de estudo reflexivo sobre participação social e as articulações entre serviços governamentais e não-governamentais na construção da consolidação do Sistema Único de Saúde, destacando o papel dos voluntários e dos profissionais de saúde nesse processo. Na assistência à infância, essas parcerias são potenciais, pela grande amplitude e destaque das organizações sociais dirigidas às crianças, particularmente a Pastoral da Criança, tornando importante o debate sobre políticas públicas que visem a estabelecer e a fortalecer esses vínculos no âmbito local e nacional.

The aim of this research is to present perspectives on partner-ships between social organizations and governmental institutions in children's health care. This study reflects on social participation and relations between governmental and non-governmental services in constructing the consolidation of the Sistema Único de Saúde (Unified Health System), highlighting the role of volunteers and health professionals in this process. In child care, these associations are potential, due to the wide range and prominence of social organizations oriented towards chil-dren, particularly the Pastoral da Criança (the Catholic Church's Child Pastoral), which makes it important to discuss public policies aimed at establishing and strengthening these links in the local and national spheres.

En este estudio se tuvo como objetivo presentar algunas perspectivas de trabajo conjunto entre organizaciones sociales e instituciones gubernamentales en la atención a la salud del niño. Se trata de un estudio reflexivo sobre participación social y las articulaciones entre servicios gubernamentales y no gubernamentales en la construcción de la consolidación del Sistema Único de Salud, destacando el papel de los voluntarios y de los profesionales de salud en ese proceso. En la asistencia a la infancia, esas asociaciones son potenciales, por la gran amplitud y destaque de las organizaciones sociales dirigidas a los niños, particularmente la Pastoral del Niño, tornando importante el debate sobre políticas públicas que visen establecer y fortalecer esos vínculos en el ámbito local y nacional.