Binding Precedent No. 61: judicial supply of drugs not incorporated into the SUS

As of October 3, 2024, the judiciary must now follow the criteria for the judicial supply of drugs not incorporated into the Brazilian Public Health System (SUS).

The Binding Precedent No. 61 of the Federal Supreme Court (STF) was published in the Official Gazette of the Union (DOU), which establishes that the Judiciary must observe the requirements defined in theses established by the STF for the judicial supply of drugs registered with the National Health Surveillance Agency (Anvisa), but not incorporated into the SUS.

The requirements to be observed are:

1. Prior refusal to have the drug supplied through the administrative route.
2. Illegality on the decision of incorporation of the drug by the National Commission for the Incorporation of Technologies into the SUS (Conitec); lack or delay in the request for incorporation; considering the deadlines and criteria provided for in articles 19-Q and 19-R of Law No. 8,080/1990 and Decree No. 7,646/2011.
3. Lack of therapeutic alternative listed in the SUS and Clinical Protocols and Therapeutic Guidelines.
4. Proof of the efficacy, accuracy, effectiveness and safety of the drug, considering evidence-based medicine, necessarily supported by high-level scientific evidence.
5. Clinical indispensability of the treatment, proven by a well-founded medical report, including a description of the treatment already performed.
6. Financial inability to pay for the cost of the drug.

Under penalty of nullity of the judicial decision, the judiciary must, when assessing a request for the supply of non-incorporated drugs:

1. Analyze the administrative act of commission or omission of non-incorporation by Conitec or the refusal to supply via the administrative route, in light of the circumstances of the specific case and the legislation in force, especially the public policy of the SUS, not being possible to incur in the merits of the administrative act.
2. Assess the presence of the requirements for dispensing the drug, based on prior consultation with the Technical Support Center of the Judiciary (NATJUS), whenever available in the respective jurisdiction, or with entities or persons with technical expertise in the area, and the decision cannot be based solely on a prescription, report or medical report attached to the records by the plaintiff; and
3. In the case of a positive judicial decision to supply the drug, notify the competent bodies to evaluate the possibility of its incorporation within the scope of the SUS.

The provision of these requirements aims to bring greater uniformity to judicial decisions, avoiding the indiscriminate granting of drugs not incorporated into the SUS and, at the same time, balancing the individual right to health with the sustainability of the public health system.

Binding Precedent No. 61 shall come into force upon its publication in the DOU, pursuant to article 103-A of the Federal Constitution and Law No. 11,417/2006. Therefore, as of October 3, 2024, all bodies of the judiciary and public administration, at federal, state and municipal levels, must comply with the above.

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