The Brazilian Supreme Federal Court (STF) has concluded two important judgments related to the judicialization of medications: Themes 1234 and 6. Both discuss the granting of medications that are not yet part of the Unified Health System (SUS) and have significant impacts on the judiciary and the health system.
1. Theme 1234: Jurisdiction and Legitimacy. Theme 1234 (RE 1,366,243) established definitions regarding the jurisdiction for processing lawsuits seeking the granting of medications not included in the SUS and the passive legitimacy of public entities.
Now, lawsuits seeking the provision of medications (i) whose annual cost exceeds 210 minimum wages or (ii) that are not registered with the Brazilian drug agency (ANVISA) must necessarily be filed against the Union and processed in Federal Court. Other lawsuits (seeking the provision of medications registered with ANVISA and whose annual treatment cost is less than 210 minimum wages) must be filed against States and Municipalities and processed in State Courts.
The decision also aims to improve the control of administrative requests, mandating the creation of a national platform to centralize these demands. Another important point was the creation of Binding Precedent No. 60, which defines that requests for medications must obligatorily observe the rules of Theme 1234.
2. Theme 6: Criteria for Granting Medications. Theme 6 (RE 566,471), in turn, establishes the necessary criteria for the judicial granting of medications not included in the SUS lists. The STF determined that the judicial granting of medications should be an exception, and that public entities will only be obligated to provide them if six cumulative criteria are met: (i) denial of provision through the administrative route; (ii) illegality in the decision not to incorporate the medication, absence of a request for incorporation, or excessive delay in its analysis; (iii) non-existence of a therapeutic alternative in the SUS; (iv) proof of efficacy based on scientific evidence; (v) clinical indispensability of the treatment; and (vi) the patient’s financial incapacity.
As in Theme 1234, Binding Summary No. 61 was also edited, which defines that requests for medications registered with ANVISA but not included in the dispensing lists of the Unified Health System must observe the theses established in the judgment of Theme 6
The judgments of Themes 1234 and 6 by the STF represent a milestone in the search for a balance between the right to health and the sustainability of the system. The new rules, by establishing more rigorous criteria for the judicial granting of medications, aim to rationalize public spending and guarantee equitable access to treatments. However, it is essential that civil society and healthcare professionals closely monitor the implementation of these new rules, seeking to ensure that patients’ rights are fully respected.
