Evidence-based process for decision-making in the analysis of legal demands for medicines in Brazil.
Legal actions have been playing a significant role as an alternative pathway to access to medicines in Brazil. These lawsuits demand medicines used in Primary Health Care as well as medicines that are still in clinical research and have not been market approved by the Brazilian National Agency for Sanitary Surveillance (ANVISA). The goal was to analyze medicines demanded through lawsuits brought to the judicial district which includes the city of Rio de Janeiro, Brazil, from July/2007 to June/2008. The medicines in 281 lawsuits were examined for their respective indications, classified according to their presence in publicly-funded lists, market approval by ANVISA, compliance with national clinical guidelines, existence of alternative therapies in lists and support of indication by scientific evidence. Six different categories were described, which are deemed useful to managers and the Judiciary in decision-making. The support of evidence is of utmost importance for medicines that are not included in public funding lists and also for those with no available therapeutic alternatives.
Complexo Tecnológico de Medicamentos, Instituto de Tecnologia em Fármacos, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil. tatianafigueiredo@far.fiocruz.br
Tatiana Aragão
TA
Figueiredo
Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil.
Claudia Garcia Serpa
CG
Osorio-de-Castro
Escola Nacional de Saúde Pública Sergio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro, Brasil.
Vera Lúcia Edais
VL
Pepe
D001938:Brazil; D003657:Decision Making; D018954:Drugs, Essential / Q000600:supply & distribution*; D019317:Evidence-Based Medicine; D006291:Health Policy / Q000331:legislation & jurisprudence; D006297:Health Services Accessibility / Q000331:legislation & jurisprudence*; D006801:Humans; D033222:Judicial Role; D028701:Patient Rights
D018954:Drugs, Essential