[Distortions to national drug policy caused by lawsuits in Brazil]. / Distorções causadas pelas ações judiciais à política de medicamentos no Brazil.

OBJECTIVE: To describe how lawsuits, which demand the supply of drugs, impact on elements of the national drug policy. METHODS: This is a desk-based study using qualitative and quantitative methods. All legal proceedings brought by citizens against the Municipal Secretary of State of Sao Paulo, relating to the supply of drugs in 2005 were analyzed. A standardized form was used to collect data, with a view to carrying out an exploratory analysis. RESULTS: A total of 170 cases relating to the supply of drugs were brought against the Municipal Secretary of State. The National Health System (SUS) was the source for 59% of the prescriptions: 26% from the municipal level, 33% from other levels. Cancer and diabetes were the diseases most commonly involved (59%). About 62% of drugs requested are on the lists of SUS services. Total expenditure was R$876,000 (Brazilian Reais), covering only non-selected items (i.e. those which are not included in the Municipal Register of Essential Medicines), 73% of which could be substituted. Of the total expenditure, 75% was spent on purchasing anticancer drugs, for which further clinical trials are required to prove their effectiveness. Two of these medicines were not registered in Brazil. CONCLUSIONS: The majority of demands for drugs that have led to legal proceedings could be avoided if two SUS directives were followed, namely the organization of oncology services and the observance of reporting on essential medicines. Failure to do so causes a breakdown in the National Drug Policy, in equality of access and in the rational use of drugs within the National Health System.