Evidence-based process for decision-making in the analysis of legal demands for medicines in Brazil

Abstract

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.

The High “Cost” of Experimental Drugs Obtained Through Health Litigation in Brazil

“…The expenses resulting from litigation have an impact on the medicines policy budget, with a reduction in the offer of other listed medicines, exams, and consultations to the general population (Paim et al, 2017). On the other hand, there seem to be inconsistencies and information failures even in the application of the SUS Protocolos Clı́nicos e Diretrizes Terapêuticas (Clinical Protocols and Therapeutic Guidelines, PCDT) (Figueiredo et al, 2013;Dias and da Silva, 2016) when regarding litigated medicines. In 2017, an audit of 414 judicial demands for medicines in Brazil showed that around half did not even include a diagnosis of the disease to be treated (Ministeŕio da Saude do Brasil, 2018d).…”

A incorporação do nusinersena no Sistema Único de Saúde: uma reflexão crítica sobre a institucionalização da avaliação de tecnologias em saúde no Brasil

“…O registro do nusinersena no Brasil aconteceu depois de rápida sucessão em várias agências no mundo. Ao contrário de muitos medicamentos de alto custo judicializados e adquiridos sem registro 21 , o nusinersena teve registro deferido antes que os gastos com atendimento de demandas judiciais fossem constatados nas compras federais. Isso pode ser explicado pelo julgamento do Tema 106 de repercussão geral no Supremo Tribunal de Justiça (STJ) 22 , que obriga o registro na Anvisa para a concessão de medicamentos não incorporados ao SUS.…”

Judicialization and Health Policy in Colombia: The Implications for Evidence‐Informed Policymaking

“…More specifically, it focuses on the use of the tutela mechanism—a protection writ through which any legal person can go before a relevant judge in the civil, criminal, or labor courts and request protection of their constitutional rights (Cepeda‐Espinosa, , p. 552)—by Colombian citizens seeking provision of core health services and treatments. The article builds on the expanding body of scholarship on the judicialization of health policy in Latin America in general (Biehl, Amon, Socal, & Petryna, ; Brinks & Forbath, ; Daniels, Charvel, Gelpi, Porteny, & Urrutia, ; Ferraz, ; Figueiredo, Osorio‐De‐Castro, & Pepe, ; Gargarella, ; Menicucci & Machado, ; Vargas‐Peláez, Rover, Leite, Buenaventura, & Farias, ; Wang, ), and in Colombia more specifically (Bernal et al, ; Cepeda‐Espinosa, ; González & Durán, ; Landau, ; Nunes, ; Uprimny, ; Yamin & Parra‐Vera, ).…”