Brasília – The Supreme Court (STF) has ruled that its general-precedent thesis—establishing criteria for judicial orders of medications not listed in the SUS—applies immediately to all ongoing legal actions. The court declined to modulate effects or restrict the ruling to future cases.

Under the precedent set in October 2024, the judiciary may only mandate the supply of off-list but Anvisa-registered medications when all of the following conditions are met cumulatively: administrative supply was denied; the non‐incorporation is illegal or unaddressed in a timely manner; no substitute exists in SUS; the treatment is clinically indispensable and backed by high-level scientific evidence; and the patient demonstrates financial inability to purchase the medication.

Justice Luís Roberto Barroso, the rapporteur, urged restraint from the judiciary in overriding technical decisions made by Conitec and the Health Ministry, stating, “In no circumstances may a magistrate substitute technical criteria established by public administration for medication approvals.”

Source: Migalhas

Would you like a complete analysis on this? Contact us at pharmabrnews@gmail.com