BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
Medical Devices: ANVISA RDC No 608/2022 For medical devices without marketing authorisation, ANVISA provides a compassionate use mechanism regulated by ANVISA RDC No 608/2022. This reso- lution establishes criteria under which patients with serious or life-threatening conditions, for whom no satisfactory market alternatives are available, may access experimental or still-developing devices. The regulation requires a favourable risk-benefit assess- ment and provides for individualised evaluation of each request based on the patient’s clinical condition and the device’s development stage. Key Limitations These mechanisms do not constitute regular market- ing authorisation and do not permit broad commer- cial distribution in Brazil. They operate as regulated exceptions allowing controlled and monitored access. The sponsor or responsible party must provide the product free of charge or under specific conditions and report safety data as required by ANVISA. Judicialisation Beyond the administrative pathways regulated by ANVISA, patients in Brazil frequently seek access to unauthorised medicines through the courts, a phe- nomenon known as the judicialisation of health ( judi- cialização da saúde ). This has become a significant challenge for public health administrators, requiring several billions of reais in annual expenditure across federal, state and municipal budgets. The Supreme Federal Tribunal ( Supremo Tribunal Fed- eral – STF), in RE 657.718 (Tema 500) , decided in May 2019), established binding precedent on the judicial supply of unregistered medicines and upheld the con- stitutionality of Article 19-T of Law 8.080/1990, which prohibits SUS payment, reimbursement, or refund of experimental medicines or medicines not authorised by ANVISA. The court’s thesis, with general repercus- sion, is in essence as follows. • The state cannot be compelled to supply experi- mental medicines under any circumstances. • The absence of ANVISA registration prevents, as a rule, the judicial supply of medicines. • Exceptionally, judicial supply of an unregistered medicine may be granted when there is unrea-
sonable delay by ANVISA in deciding a pend- ing registration request, measured against the maximum decision periods established by Law No 13,411/2016, including only the single justified extension of up to one-third allowed by that law, and when three cumulative requirements are met: (i) existence of a registration application pending before ANVISA in Brazil, except for orphan medi- cines for rare and ultra-rare diseases; (ii) existence of registration in renowned regulatory agencies abroad, such as the US Food and Drug Adminis- tration (FDA) or the European Medicines Agency (EMA); and (iii) absence of a therapeutic substitute with registration in Brazil. Any court-ordered supply must also observe CMED price regulation to avoid supra-cap payments. • Actions demanding the supply of medicines with- out ANVISA registration must necessarily be filed against the union in federal court. The STF emphasised that excessive judicialisation has not achieved its intended systemic goals, because individualised injunctions divert scarce resources from collectively designed public policies. It is also worth noting that two adjacent STF rulings help situate Tema 500 within the broader landscape. In 2021, Tema 1.161 addressed medicines that lack ANVISA registration but have ANVISA authorisation for individual importation, allowing, in exceptional cases, judicial supply upon cumulative proof of clinical indis- pensability, absence of a SUS-listed substitute and the patient’s economic insufficiency. In 2024, the STF also addressed claims involving medicines registered at ANVISA but not incorporated into SUS, imposing stricter evidentiary and procedural requirements and clarifying jurisdictional rules. These later decisions do not alter Tema 500’s general bar for unregistered medicines; rather, they delineate separate lanes for import-authorised unregistered products and for reg- istered-but-not-incorporated products while maintain- ing deference to ANVISA’s and CONITEC’s roles, and to CMED price discipline. 3.6 Ongoing Obligations Imposed by Marketing Authorisations ANVISA marketing authorisation creates ongoing obligations for both medicines and medical devices
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