Brazil’s Supreme Court updates framework for reimbursement and jurisdiction over oncology therapies

On February 19, 2026, Brazil’s Federal Supreme Court (“STF”) ratified an agreement establishing new reimbursement guidelines and defining jurisdiction for lawsuits involving access to cancer therapies in the Brazilian Unified Health System (“SUS”).

The agreement – signed between the federal government, states, and municipalities within the context of the Tripartite Interagency Committee (CIT) – was unanimously approved during the Court’s review of Ordinance GM/MS No. 8,477/2025, which established the Oncology Pharmaceutical Assistance component within the SUS (“AF‑ONCO”) and reorganized the Brazilian model of pharmaceutical care in oncology.

Below are the key issues addressed by the STF: 

Reimbursement rules: Federal government maintains 80% coverage

The agreement preserves the existing cost-sharing mechanism for oncology medicines, maintaining the federal government reimbursement of 80% of the amounts spent by states and municipalities to comply with court orders requiring the supply of oncology therapies.

This percentage remains valid for lawsuits filed up to June 10, 2024, and, on a provisional basis, for those filed after that date. This extension is temporary and will remain in force until a new inter-federative agreement is reached and subsequently approved by the STF.

STF justices emphasized this rule during the review, especially given the financial constraints faced by many municipalities, which often lack the budgetary capacity to fund high-cost cancer medicines.

Medicines incorporated into the SUS: inclusion of a new thesis under Topic 1234

Another central development was the update to the STF’s thesis under Topic 1234, aligning it with Ordinance GM/MS No. 8,477/2025 – particularly regarding jurisdiction over cases involving oncology medicines already incorporated into SUS.

The previous thesis assigned jurisdiction to the Federal Courts when a claim involved access to medicines costing the equivalent of 210 minimum wages or more per year. The new ordinance, however, redefined jurisdiction based on the level of pharmaceutical assistance involved, as follows:

• Oncology medicines centrally procured by the Ministry of Health: Treated as equivalent to Group 1A medicines under the SUS Specialized Pharmaceutical Component. Lawsuits seeking access to these products fall under Federal Court jurisdiction.
• Oncology medicines purchased through national or decentralized negotiations: Treated as equivalent to Group 1B medicines under the Specialized Pharmaceutical Component. Claims involving these medicines fall under State Court jurisdiction.

Updating the thesis required special attention to the transition between models. To prevent mass redistribution of ongoing cases, the STF applied a transitional rule: the change in jurisdiction applies only to lawsuits filed from October 22, 2025, onward (the publication date of Ordinance GM/MS No. 8,477/2025).

Collaborative judicial governance framework

The STF also reaffirmed collaborative judicial governance as a structural pillar of Topic 1234, emphasizing that managing health-related litigation requires continuous coordination among federal, state and municipal authorities.

According to Justice Gilmar Mendes’ vote, this governance model enables complex public policies, such as oncological pharmaceutical care, to be adjusted through formally constructed inter-federative consensus and subsequently approved by the STF to ensure full legal effectiveness.

The Court further noted that any future changes in reimbursement rules or judicial competence will likewise require judicial approval, ensuring regulatory continuity and national uniformity.

Demarest’s Life Sciences and Healthcare team is available to provide any further clarifications that may be necessary.