Legal access to medications: a threat to Brazil's public health system?

BACKGROUND: In Brazil, health is fundamental human right guaranteed by the Constitution of 1988, which created the Brazilian Universal Health System (Sistema Único de Saúde - SUS). The SUS provides medications for outpatient care via policy of pharmaceutical assistance (PA) programmes. Despite the advances in PA policies which include the improvement in access to medications, there has been a significant increase in lawsuits related to health products and services. This study aimed to characterize the medication processes filed between 2010 and 2014 against the Secretary of State for Health of São Paulo (State Health Department of São Paulo - SES/SP), in Brazil, following PA policies. METHODS: This descriptive study used secondary data on medication lawsuits filed against the SES/SP between 2010 and 2014. The data source was the S-Codes computerized system. RESULTS: In the period evaluated, the number of lawsuits filed concerning health-related products increased approximately 63%; requests for medications were predominant. Approximately 30% of the medications involved in court proceedings were supplied via PA programmes. With regard to medications supplied via specialized component, 81.3% were prescribed in disagreement with the protocols published by the Ministry of Health. Insulin glargine was the most requested medication (6.3%), followed by insulin aspart (3.3%). Because there is no scientific evidence that either of these medicines is superior for the treatment of diabetes, neither of them has been incorporated into the SUS by the National Commission for Technology Incorporation. The judicial data showed that most of the lawsuits involved normal proceedings (i.e., individual demands), were filed by private lawyers, and named the State of São Paulo as the sole defendant, demonstrating the individual nature of these claims. The data indicate inequality in the distribution between the number of cases and lawyers and the number of lawsuits and prescribers, evidencing the concentration of lawyers and physicians in filing lawsuits. CONCLUSION: The judicialization of health in the State of São Paulo with the characteristics presented herein is a threat to the SUS.

Judicialização da polí­tica pública de assistência farmacêutica e equidade

Este trabalho caracterizou as demandas judiciais para obtenção de medicamentos sob a ótica da judicialização da polí­tica pública e da quebra do princípio da equidade na dimensão coletiva.

Legal suits: pharmaceutical industry strategies to introduce new drugs in the Brazilian public healthcare system.

OBJECTIVE: To assess the distribution rate of legal suits according to drug (manufacturer), prescribing physician, and attorney filing the lawsuit. METHODS: A descriptive study was carried out to assess the lawsuits in the São Paulo State (Southeastern Brazil) courts registry in 2006, and amounts spent in complying with these lawsuits, and total costs with medication thus resulting. RESULTS: In 2006, the São Paulo State Administration spent 65 million Brazilian reais in compliance with court decisions to provide medication to approximately 3,600 individuals. The total cost of the medication was 1.2 billion Brazilian reais. In the period studied, 2,927 lawsuits were examined. These lawsuits were filed by 565 legal professionals, among which 549 were attorneys engaged by private individuals (97.17% of the total legal professionals). The drugs scope of the lawsuits had been prescribed by 878 different physicians. By assessing the number of lawsuits filed per attorney, it was found that 35% of them were brought before the courts by 1% of them. CONCLUSIONS: The data related to the lawsuits and to the medication classified according to manufacturer, show that a small number of attorneys is responsible for the largest number of lawsuits filed to obtain these drugs. The finding that more than 70% of the lawsuits filed for certain drugs are the responsibility of one single attorney, may suggest a close connection between this professional and the manufacturer.

Ações judiciais: estratégia da indústria farmacêutica para introdução de novos medicamentos / Acciones judiciales: estrategia de la industria farmacéutica para introducción de nuevos medicamentos / Legal suits: pharmaceutical industry strategies to introduce new drugs in the Brazilian public healthcare system

OBJETIVO: Analisar a concentração na distribuição dos processos judiciais segundo medicamento (fabricante), médico prescritor e advogado impetrante da ação. MÉTODOS: Estudo descritivo que analisou processos judiciais cadastrados em sistema de controle judicial do Estado de São Paulo, em 2006, gastos realizados com o atendimento às ações judiciais e gastos totais de medicamentos. RESULTADOS: Em 2006, foram gastos 65 milhões de reais pelo estado de São Paulo com o cumprimento das decisões judiciais para atender a cerca de 3.600 pessoas. O gasto total em medicamentos foi de 1,2 bilhão de reais. No período estudado foram analisadas 2.927 ações, que foram ajuizadas por 565 agentes, dos quais 549 eram advogados particulares (97,2 por cento do total de agentes). Os medicamentos solicitados nas demandas judiciais analisadas foram prescritos por 878 médicos diferentes. Ao analisar o número de ações ajuizadas por advogado, observa-se que 35 por cento das ações foram apresentadas por 1 por cento dos advogados. CONCLUSÕES: Os dados das ações com os medicamentos classificados pelo seu fabricante mostram que poucos advogados são responsáveis pela maioria das demandas judiciais desses medicamentos. A observação de que mais de 70 por cento das ações ajuizadas para certos medicamentos são de responsabilidade de um advogado pode sugerir uma relação estreita entre o advogado e o fabricante do medicamento.

OBJETIVO: Analizar la concentración en la distribución de los procesos judiciales según medicamento (fabricante), medico prescriptor y abogado impetrante de la acción. MÉTODOS: Estudio descriptivo que analizó procesos judiciales catastrados en sistema de control judicial del estado de Sao Paulo, sureste de Brasil, en 2006, gastos realizados con la atención de las acciones judiciales y gastos totales de medicamentos. RESULTADOS: En 2006, fueron gastados 65 millones de reales por el estado de Sao Paulo con el cumplimiento de las decisiones judiciales para atender cerca de 3.600 personas. El gasto total en medicamentos fue de 1,2 billones de reales. En el período estudiado fueron analizadas 2.927 acciones, estas fueron enjuiciadas por 565 agentes de los cuales 549 eran abogados particulares (97,2% del total de agentes). Los medicamentos solicitados en las demandas judiciales analizadas fueron prescriptos por 878 médicos diferentes. Al analizar el número de acciones enjuiciadas por abogado, se observa que 35% de las acciones fueron presentadas por 1% de los abogados. CONCLUSIONES: Los datos de las acciones con los medicamentos clasificados por su fabricante muestran que pocos abogados son responsables por la mayoría de las demandas judiciales de dichos medicamentos. La observación de que más de 70% de las acciones enjuiciadas para ciertos medicamentos son de responsabilidad de un abogado, puede sugerir una relación estrecha entre el abogado y el fabricante del medicamento.

['Judicialization' of public health policy for distribution of medicines]. / Judicialização da política pública de assistência farmacêutica e eqüidade.

The supply of medicines in response to court orders or injunctions has become a common practice in the State of São Paulo, Brazil. This 'judicialization' of the health system clashes with basic principles of the Brazilian Unified National Health System (SUS), such as equal opportunity to access health services. The aim of this paper is to analyze the legal action used to obtain medicines through the São Paulo State Health Department, from two main angles: judicialization of public policies and breach of the equity principle. This is a descriptive study of legal action taken to obtain medicines through the São State Health Department, as listed in the Electronic Court Docket System for the year 2006. Most cases were filed through private attorneys; 47% of the patients had obtained their prescriptions through private care; and 73% of the cases involved patients from the three wealthiest areas in the city of São Paulo. The data demonstrate that such legal action violates key principles of the SUS such as equity, thereby privileging individuals with higher purchasing power and more access to information.

Judicialização da política pública de assistência farmacêutica e eqüidade / "Judicialization" of public health policy for distribution of medicines

O fornecimento de medicamentos por ação judicial, pela Secretaria de Estado da Saúde de São Paulo (SES-SP), tornou-se uma prática rotineira e cada vez mais freqüente. A judicialização do sistema de saúde entra em confronto com princípios básicos do SUS, como o da eqüidade. Este trabalho caracterizou as demandas judiciais para obtenção de medicamentos sob a ótica da judicialização da política pública e da quebra do princípio da eqüidade na dimensão coletiva. O estudo é um trabalho descritivo dos processos judiciais de solicitação de medicamentos à SES-SP relacionados no Sistema de Controle Jurídico (SCJ) no ano 2006. A maioria das ações analisadas foi ajuizada por advogados particulares; 47 por cento dos pacientes possuíam receitas da rede privada e cerca de 73 por cento dos processos foram provenientes de pacientes residentes nos três estratos de menor vulnerabilidade social do Município de São Paulo, Brasil. Os dados demonstram que essas demandas judiciais não respeitam princípios do SUS como o da eqüidade, privilegiando indivíduos com melhor poder aquisitivo e com acesso à informação.

The supply of medicines in response to court orders or injunctions has become a common practice in the State of São Paulo, Brazil. This "judicialization" of the health system clashes with basic principles of the Brazilian Unified National Health System (SUS), such as equal opportunity to access health services. The aim of this paper is to analyze the legal action used to obtain medicines through the São Paulo State Health Department, from two main angles: judicialization of public policies and breach of the equity principle. This is a descriptive study of legal action taken to obtain medicines through the São State Health Department, as listed in the Electronic Court Docket System for the year 2006. Most cases were filed through private attorneys; 47 percent of the patients had obtained their prescriptions through private care; and 73 percent of the cases involved patients from the three wealthiest areas in the city of São Paulo. The data demonstrate that such legal action violates key principles of the SUS such as equity, thereby privileging individuals with higher purchasing power and more access to information.