Health Litigation and the Brazilian Supreme Court (STF): binding precedent no. 61 published

The Brazilian Supreme Federal Court (STF) published on October 3rd the Binding Precedent No. 61, which addresses the court-ordered provision of medications registered with ANVISA but not included in the Brazilian Unified Health System (SUS) dispensing lists.

Binding Precedent No. 61

The court-ordered provision of medication registered with ANVISA but not included in the Unified Health System (SUS) dispensing lists must observe the theses established in the judgment of General Repercussion Theme 6 (RE 566.471).

Theme 6 context

Although the established thesis states that the absence of a medication in the SUS lists prevents its provision by a judicial decision, there are exceptions, if the following cumulative requirements are met:

• Administrative refusal to provide: The medication must have been administratively refused, as per item ‘4’ of General Repercussion Theme 1234.

• Illegality or absence of incorporation request by Conitec: There must be unlawfulness in the act of not incorporating the medication by Conitec, failure to request incorporation, or delay in its evaluation, according to the deadlines and criteria provided in the legislation.

• Impossibility of substitution: There must be no possibility of substitution by another medication listed in the SUS and clinical protocols and therapeutic guidelines.

• Scientific evidence: The efficacy, accuracy, effectiveness, and safety of the medication must be proven based on evidence-based medicine, supported by high-level scientific evidence such as randomized clinical trials and systematic reviews or meta-analyses.

• Clinical indispensability: The clinical necessity of the treatment must be proven through a well-founded medical report, including a description of the treatment already performed.

• Financial incapacity: The patient must prove financial incapacity to bear the cost of the medication.

Relation to Theme 1234

Theme 1234 complements this discussion by addressing the passive standing of the Union and the jurisdiction of the Federal Court in demands for the provision of medications registered with ANVISA but not standardized by SUS. It establishes that administrative refusal to provide is one of the requirements for the court-ordered provision of these medications.

Details of Theme 1234

• Passive standing of the Union: The Union must be included as a defendant in actions seeking the provision of medications not incorporated into SUS public policies but registered with ANVISA. This means that the Union is responsible for responding judicially in these cases.

• Jurisdiction of Federal Courts: Demands related to medications not incorporated into SUS public policy but registered with ANVISA must be processed in the Federal Jurisdiction when the annual cost of the specific medication treatment is equal to or greater than 210 minimum wages. If the cost is between 7 and 210 minimum wages, the action will be judged in the State Court, with the Union reimbursing part of the expenses.

• Criteria for Defining Non-Incorporated Medications: Non-incorporated medications are those not included in SUS public policy, medications provided in PCDTs (Clinical Protocols and Therapeutic Guidelines) for other purposes, medications without ANVISA registration, and off-label medications (used outside approved indications) without PCDT or not included in the basic component lists.

It is expected that court decisions about medication provisions will be standardized with the STF’s Binding Precedent.

The Life Sciences & Healthcare team is monitoring the application of this ruling in the courts.