Brasília – The Brazilian Supreme Federal Court (STF) held a public hearing on Monday (10) to monitor compliance with Theme 1234, which governs access to medicines registered by Anvisa but not incorporated into the SUS. During the session, the Court set 1 December 2025 as the deadline for all involved bodies to submit an integrated action plan detailing the technical measures needed to implement the decision issued in Extraordinary Appeal 1366243.

Minister Gilmar Mendes, who convened the debate, reinforced that pricing should occur in coordination with the sanitary registration process to prevent distortions driven by judicialization. He called for stronger negotiation capacity to ensure Brazil pays prices aligned with international benchmarks.

Interventions from Anvisa, CMED, the Ministry of Health, Ministry of Finance, academia and civil society highlighted the need to synchronize registration, pricing and incorporation, reduce regulatory gaps, and strengthen economic governance. Anvisa’s president, Leandro Safatle, defended a sequential but fully integrated model, whereas CMED emphasized upcoming regulatory updates to modernize price-setting for advanced therapies. Representatives also stressed the role of the National Health Platform, expected to be presented on 1 December 2025, as a key tool for transparency and inter-federative coordination.

The debate underscored the structural challenges of judicialization, market asymmetries, and rising costs of innovative therapies, with experts advocating for clearer rules, agile regulation, and stronger cooperation among Anvisa, CMED, Conitec, and the Ministry of Health. The STF reaffirmed that publication of the sanitary registration must be conditioned on the filing of the pricing request, in line with Article 16 of Law 6.360/1976, and that the forthcoming action plan must provide concrete steps, timelines, and governance mechanisms to ensure full implementation of Theme 1234.

Source: NK Consultores