Essentiality and legal access to medicines

Brazilian Constitution establishes health as a citizen’s right and the State as responsible for its provision. Brazilian Health System (SUS) is in charge of dispensing comprehensive therapeutic care, including pharmaceutical services. National Medicines Policy and National Pharmaceutical Services Policy were approved to guarantee access to essential medicines. Unfortunately, problems in equitable access persist, which contributed to the phenomenon called health litigation, current in the last twenty years but growing steadily. A taut line has been established between health sector and judicial system, which is supported by distinct concepts as to the nature of what is and what is not essential. This sectional study was planned to analyze court of appeals judicial decisions for individual lawsuits on access to medicines considered as essential by the Judicial system, in the State of Rio de Janeiro and identify and describe meanings related to the concept of essentiality, by the health sector and by the Judicial system. Main data sources were the webpage of the State Court and the identified cases from the court of appeals, which had been closed in 2006 and archived until December 31 2007. Of 3,456 cases concerning medicines, 190 were identified as having registered “medicines” and “essential” and 27 cases were selected. All demands were been granted. A substantial part medicines were for chronic diseases such as hypertension and diabetes, provided by the public health system, but 25 had at least one drug which was not in official lists of drugs financed by SUS. From the judicial point of view, essentiality relates to the existence of a prescription and not to concepts expressed in pharmaceutical policies. Results are expected to contribute to adequate application not only of ethical and legal principles in national legislation, but also of scientific guidelines in management of medicines and in judicial decisions.