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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.

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