On September 6, 2024, the Federal Supreme Court (STF) began the trial of RE 566,471 (Theme 6 RG), a process in which the State’s duty to provide high-cost medicines to those who suffer from a serious illness and do not have the financial capacity to bear the costs of treatment is discussed.
In a session held on September 16, the STF decided on the thesis with general repercussion, in the sense that, exceptionally, the Judiciary can grant an order to determine the supply of a medicine registered with ANVISA, but not incorporated into the lists of the Unified Health System, if the following requirements are met:
– refusal to supply medication through administrative channels;
– Absence, illegality or delay in incorporating the medicine by CONITEC;
– impossibility of substitution by another medication included in the SUS lists and clinical protocols and therapeutic guidelines;
– proof of the effectiveness and safety of the drug through scientific evidence;
– essential treatment, proven by medical report;
– financial inability to afford the cost of the medication.
Due to the general repercussion, the STF decision must be applied to cases that are yet to be judged.
