As emendas parlamentares no orçamento federal da saúde / Congressional amendments to the Brazilian Federal health budget

O orçamento público brasileiro passou por mudanças na Constituição Federal de 1988. Instituíram-se mecanismos para integração das atividades de planejamento e orçamento, e definiram-se formas de participação do Poder Legislativo no processo orçamentário. As emendas parlamentares surgem nesse contexto. O artigo discute a participação das emendas no orçamento federal da saúde no período de 1997 a 2006, reunindo elementos para a análise dos mecanismos de financiamento e planejamento setorial. Verificou-se uma participação significativa das emendas no período, reunindo mais da metade dos recursos de investimento em alguns anos. A Região Norte destaca-se pelo aporte de recursos, indicando a necessidade de estudos que aprofundem a relação entre destino de emendas e coalizões político-partidárias. Conclui-se que as emendas não podem ser compreendidas apenas como um mecanismo de financiamento, mas também como um mecanismo da política, não estando submetidas obrigatoriamente à lógica do planejamento, o que reforça a necessidade de maior transparência do poder público na execução orçamentária.

The public budget in Brazil has undergone significant changes since enactment of the 1988 Federal Constitution. Mechanisms for integration of planning activities and budget execution have been created, and Legislative participation in budgeting has increased. Congressional amendments appeared in this context. The article discusses the participation of Congressional amendments in the Federal health budget from 1997 to 2006, combining elements for discussion of funding mechanisms and health planning. Such amendments played a significant role in the budget process, accounting for over half of health funds in some years. The North was the region of Brazil that received most resources resulting from Congressional amendments, suggesting the need for further studies on the relationship between the amendments' enforcement and political party coalitions. The article concludes that the amendments cannot be understood solely as a funding mechanism, but mainly as a political instrument, and that they are not necessarily subject to health planning logic.

[Implementation of the International Health Regulations in Cuba: evaluation of basic capacities of the health sector in selected provinces]. / Implementación del Reglamento Sanitario Internacional en Cuba: evaluación de capacidades básicas del sector salud en provincias seleccionadas.

OBJECTIVE: Obtain baseline information on the status of the basic capacities of the health sector at the local, municipal, and provincial levels in order to facilitate identification of priorities and guide public policies that aim to comply with the requirements and capacities established in Annex 1A of the International Health Regulations 2005 (IHR-2005). METHODS: A descriptive cross-sectional study was conducted by application of an instrument of evaluation of basic capacities referring to legal and institutional autonomy, the surveillance and research process, and the response to health emergencies in 36 entities involved in international sanitary control at the local, municipal, and provincial levels in the provinces of Havana, Cienfuegos, and Santiago de Cuba. RESULTS: The polyclinics and provincial centers of health and epidemiology in the three provinces had more than 75% of the basic capacities required. Twelve out of 36 units had implemented 50% of the legal and institutional framework. There was variable availability of routine surveillance and research, whereas the entities in Havana had more than 40% of the basic capacities in the area of events response. CONCLUSIONS: The provinces evaluated have integrated the basic capacities that will allow implementation of IHR-2005 within the period established by the World Health Organization. It is necessary to develop and establish effective action plans to consolidate surveillance as an essential activity of national and international security in terms of public health.

Implementación del Reglamento Sanitario Internacional en Cuba: evaluación de capacidades básicas del sector salud en provincias seleccionadas / Implementation of the International Health Regulations in Cuba: evaluation of basic capacities of the health sector in selected provinces

Objetivo. Obtener información de línea base sobre el estado de las capacidades básicas delsector salud a nivel local, municipal y provincial, a fin de facilitar la identificación de prioridadesy orientar las políticas públicas dirigidas a garantizar los requisitos y capacidades establecidosen el Anexo 1A del Reglamento Sanitario Internacional de 2005 (RSI-2005).Métodos. Se realizó un estudio descriptivo de corte transversal mediante la aplicación de uninstrumento de evaluación de capacidades básicas referidas a la autonomía legal e institucional,el proceso de vigilancia e investigación y la respuesta frente a emergencias sanitarias en36 entidades involucradas en el control sanitario internacional de los niveles local, municipaly provincial en las provincias de La Habana, Cienfuegos y Santiago de Cuba.Resultados. Los policlínicos y centros provinciales de higiene y epidemiología de las tres provinciascontaban con más del 75% de las capacidades básicas requeridas. Doce de 36 unidadesdisponían del 50% del marco legal e institucional implementado. La vigilancia e investigaciónde rutina presentaron una disponibilidad variable, mientras que las entidades de La Habanacontaron con más del 40% de capacidades básicas en el campo de la respuesta ante eventos.Conclusiones. Las provincias evaluadas cuentan con capacidades básicas instaladas quepermitirán la implementación del RSI-2005 según el plazo previsto por la Organización Mundialde la Salud. Es necesario establecer y desarrollar planes de acción eficaces para consolidara la vigilancia como una actividad esencial de seguridad nacional e internacional en términosde salud pública.

Objective. Obtain baseline information on the status of the basic capacities ofthe health sector at the local, municipal, and provincial levels in order to facilitateidentification of priorities and guide public policies that aim to comply with therequirements and capacities established in Annex 1A of the International HealthRegulations 2005 (IHR-2005).Methods. A descriptive cross-sectional study was conducted by application ofan instrument of evaluation of basic capacities referring to legal and institutionalautonomy, the surveillance and research process, and the response to healthemergencies in 36 entities involved in international sanitary control at the local,municipal, and provincial levels in the provinces of Havana, Cienfuegos, andSantiago de Cuba.Results. The polyclinics and provincial centers of health and epidemiology in thethree provinces had more than 75% of the basic capacities required. Twelve out of36 units had implemented 50% of the legal and institutional framework. There wasvariable availability of routine surveillance and research, whereas the entities inHavana had more than 40% of the basic capacities in the area of events response.Conclusions. The provinces evaluated have integrated the basic capacities thatwill allow implementation of IHR-2005 within the period established by the WorldHealth Organization. It is necessary to develop and establish effective action plans toconsolidate surveillance as an essential activity of national and international securityin terms of public health.

[Congressional amendments to the Brazilian Federal health budget]. / As emendas parlamentares no orçamento federal da saúde.

The public budget in Brazil has undergone significant changes since enactment of the 1988 Federal Constitution. Mechanisms for integration of planning activities and budget execution have been created, and Legislative participation in budgeting has increased. Congressional amendments appeared in this context. The article discusses the participation of Congressional amendments in the Federal health budget from 1997 to 2006, combining elements for discussion of funding mechanisms and health planning. Such amendments played a significant role in the budget process, accounting for over half of health funds in some years. The North was the region of Brazil that received most resources resulting from Congressional amendments, suggesting the need for further studies on the relationship between the amendments' enforcement and political party coalitions. The article concludes that the amendments cannot be understood solely as a funding mechanism, but mainly as a political instrument, and that they are not necessarily subject to health planning logic.

A dinâmica da vinculação de recursos para a saúde no Brasil: 1995 a 2004 / The dynamic binding of resources for health in Brazil: 1995 to 2004

Este estudo examina a participação federal no financiamento da saúde no Brasil, no período de 1995 a 2004, a partir das iniciativas institucionais de vinculação e indexação de recursos, levando em consideração o ajuste macroeconômico praticado no período e a influência do papel das instituições na proteção do fluxo financeiro. Examina-se a eficiência dos mecanismos institucionais adotados com o propósito de garantir a regularidade e a ampliação do fluxo de meios, analisando-se o desempenho da Contribuição Provisória sobre a Movimentação Financeira (CPMF) e da Emenda Constitucional nº 29 (EC 29), iniciativas que vêm tendo seus efeitos questionados em termos de ampliação de valores. Demonstra-se o impacto alocativo de tais medidas a partir da análise estatística do emprego em saúde dos recursos da CPMF em relação a sua arrecadação e dos efeitos das medidas de indexação de recursos da União, via EC 29, por meio da comparação do aporte federal em saúde antes e após a sua aplicação.

The aim of this study is to discuss the Brazilian Federal participation in the financing health sector from 1995 to 2004, having the basis the resources of the institutional initiatives related to the indexation of expenses, considering the macroeconomic adjustment practiced in that period and the institutions role to protect the cash flow. Examining the performances of the institutional mechanism actually adopted with the purpose of guarantee the flow regularity and extension of the values, by the analisys of the Temporary Contribution on the Financial Movement (TCFM) and the Constitutional Amendment Number 29 (CA 29) whose initiatives has their efficiency questioned. It demonstrates the impact of the destination of such measures from the statistics analysis of the use of the resources of the TCFM regarding its levies and the indexation of Union resources effects measures from the CA 29 before and after the application of its determinations.

[The dynamic binding of resources for health in Brazil: 1995 to 2004]. / A dinâmica da vinculação de recursos para a saúde no Brasil: 1995 a 2004.

The aim of this study is to discuss the Brazilian Federal participation in the financing health sector from 1995 to 2004, having the basis the resources of the institutional initiatives related to the indexation of expenses, considering the macroeconomic adjustment practiced in that period and the institutions role to protect the cash flow. Examining the performances of the institutional mechanism actually adopted with the purpose of guarantee the flow regularity and extension of the values, by the analisys of the Temporary Contribution on the Financial Movement (TCFM) and the Constitutional Amendment Number 29 (CA 29) whose initiatives has their efficiency questioned. It demonstrates the impact of the destination of such measures from the statistics analysis of the use of the resources of the TCFM regarding its levies and the indexation of Union resources effects measures from the CA 29 before and after the application of its determinations.

Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, Southeastern Brazil.

OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17% of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million. CONCLUSIONS: The results reinforce the need for technical expertise in dealing with legal suits and for capacity-building of health professionals in approaching the scientific literature, in order to appropriately select drugs and to ensure the best therapeutic decision for each clinical condition, and thus guarantee access to safe and effective health technologies and, therefore, to enhance the quality of the Brazilian pharmaceutical services model in oncology.

Uso racional de medicamentos antineoplásicos e ações judiciais no Estado de São Paulo / Uso racional de medicamentos antineoplásicos y acciones judiciales en el estado de Sao Paulo, Sureste de Brasil / Rational use of anticancer drugs and patient lawsuits in the state of São Paulo, southeastern Brazil

OBJETIVO: Avaliar a racionalidade das ações judiciais e pedidos administrativos recebidos pela Secretaria de Estado da Saúde de São Paulo segundo evidências científicas de eficácia e segurança. MÉTODOS: Estudo descritivo, transversal, baseado em informações da Secretaria de Saúde sobre os medicamentos antineoplásicos solicitados por via judicial, com maior impacto financeiro para o Sistema Único de Saúde em 2006 e 2007. Os fármacos foram avaliados quanto às evidências clínicas de eficácia e segurança, com base na classificação do Micromedex®, em metanálises e revisões sistemáticas. As indicações foram confrontadas com aquelas aprovadas em agências reguladoras. RESULTADOS: Os medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe e temozolomida geraram gastos superiores a R$ 40 milhões para atender 1.220 solicitações, com custo médio de R$ 33,5 mil por paciente. Os estudos selecionados não recomendam parte das indicações dos medicamentos prescritos. Cerca de 17 por cento dos pedidos não tinham evidência para a indicação mencionada no pleito, o que equivale a um gasto inadequado de, no mínimo, R$ 6,8 milhões...

OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the São Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex® categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17 percent of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million...

OBJETIVO: Evaluar la racionalidad de las acciones judiciales y pedidos administrativos recibidos por la Secretaria Estatal de Salud de Sao Paulo según evidencias científicas de eficacia y seguridad. MÉTODOS: Estudio descriptivo, transversal basado en informaciones de la Secretaria sobre los medicamentos antineoplásicos solicitados por vía judicial, con mayor impacto financiero para el Sistema Único de Salud en 2006 y 2007. Los fármacos fueron evaluados considerando las evidencias clínicas de eficacia y seguridad, con base en la clasificación de Micromedx®, metanálisis y revisiones sistemáticas. Las indicaciones fueron confrontadas con las aprobadas en agencias reguladoras. RESULTADOS: Los medicamentos bevacizumabe, capecitabina, cetuximabe, erlotinibe, rituximabe, imatinibe y temozolomida generaron gastos superiores a R$ 40 millones para atender 1.220 solicitudes, con costo promedio de R$ 33,5 mil por paciente. Los estudios seleccionados no recomiendan parte de las indicaciones de los medicamentos prescritos. Cerca de 17 por ciento de los pedidos no tenían evidencia para la indicación mencionada en el pleito, lo que equivale a un gasto inadecuado de, mínimo, R$ 6,8 millones...

Agenda única de saúde: a busca do acesso universal e a garantia do direito à saúde / Consolidated Health Agenda: the search for universal acess and guarantee of health right

Este trabalho visa identificar os determinantes da ampliação de demandas judiciais contra os gestores do SUS. Em sua maioria 85 por cento relacionam-se ao fornecimento de medicamentos e são geradas, no âmbito do Judiciário, pelo entendimento daquele órgão que o Poder Público está descumprindo o direito à saúde constitucionalmente adquirido. Foi realizada uma revisão bibliográficaacerca de sistemas nacionais de saúde com princípios constitutivos básicossemelhantes aos do SUS, tendo sido selecionados o Canadá, Colômbia eEspanha. O objetivo foi observar se àqueles sistemas apresentam asdificuldades experimentadas pelo SUS, ou se existe, no sistema nacional,alguma peculiaridade. Foram analisados os artigos da Constituição de 1988relativos à saúde, observando-se em vários deles pouca clareza na descriçãode conceitos que parecem dar margem a múltiplos entendimentos dos atoresenvolvidos com a implementação do SUS. Desenvolveu-se uma pesquisaquali-quantitativa: o 1º componente foi realizado por meio de entrevistas comatores chave, representantes do Executivo, Legislativo, Judiciário, Órgãos de Classe, Conselhos de Saúde e Gestores. A etapa quantitativa foi realizada a partir da coleta, sistematização e análise de dados acerca das demandas judiciais chegadas aos gestores do SUS localizados no Rio de Janeiro (SMS, SESDEC e NERJ). Os entendimentos dos entrevistados mostraram-se muito distintos e bastante relacionados com seus locais de atuação. Foi observado que o Judiciário, grosso modo, ratifica as prescrições médicas, determinando aos gestores, tornados réus, o fornecimento de produtos de saúde que vãodesde os medicamentos essenciais até os de dispensação excepcional emesmo, algumas substâncias importadas...