BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
8.5 Regulation of Prescriptions and Dispensing by Pharmacies
medical devices that are otherwise unavailable through conventional channels because: • the technology has not yet been incorporated into the public formulary; • the product is temporarily out of stock; or • the patient does not meet the eligibility criteria. Stricter requirements apply to the supply of unregis- tered medicines. Courts may grant such orders upon satisfaction of applicable criteria, thereby imposing exceptional funding obligations on public authorities, particularly with respect to high-cost therapies and rare-disease treatments. 8.4 Cost-Benefit Analyses The HTA in Brazil is the formal, central pathway for SUS coverage and use conditions, and its appraisals appropriately integrate comparative clinical value with economic consequences, albeit with varying depth of explicit cost-effectiveness modelling in practice. Pricing is governed by a distinct ceiling-setting regime for medicines that has been modernised through CMED Resolution No 3/2025 to clarify categories, expand external reference pricing, codify provisional prices and fix DIP timing, but that remains adminis- trative rather than value-based. Realised public sec- tor prices for medicines are shaped by procurement structures and fiscal constraints, not by HTA. For devices and IVDs, there is no national price cap regime; thus, prices are procurement driven, with HTA evidence shaping adoption and specifications. ANVI- SA’s RDC No 478/2021 also adds market transpar- ency for selected device families through mandatory reporting and publication of aggregated, technically comparable price statistics that can be used as refer- ences but do not control price. Judicialisation still persists as an exception channel that can compel funding outside formal incorporation or contrary to protocol criteria.
Brazil regulates physician prescribing and pharmacy dispensing through a layered framework combining health surveillance rules enforced by ANVISA and local authorities, with professional oversight from the medical councils (theFederal Medical Council, or Conselho Federal de Medicina (CFM), and regional medical councils, or Conselho Regional de Medicina (CRMs) and pharmacy councils (the Federal Pharma- cy Council, or Conselho Federal de Farmácia (CFF), and regional pharmacy councils (CRFs)). Prescribing and dispensing requirements vary by medi- cine classification. OTC medicines may be sold without prescriptions but face labelling and advertising restric- tions. Prescription-only medicines require clinical gate- keeping, and generic substitution is permitted unless the prescriber forbids it. Antimicrobials require two- copy prescriptions, short validity periods and electronic record-keeping. Special control substances like narcot- ics and psychotropics demand colour-coded notifica- tion forms, identity verification and periodic reporting. Physicians must adhere to evidence-based prescrib- ing standards and ethical restrictions on conflicts of interest. Pharmacies must comply with ANVISA rules and professional requirements governing dispensing practices. A notable recent development is CFF Resolution No 5/2025, which attempted to expand pharmacist pre- scribing authority but was challenged by the CFM and suspended by a federal court, creating legal uncer- tainty. Within the SUS, prescribing is shaped by formular- ies and clinical protocols and therapeutic guidelines ( protocolos clínicos e diretrizes terapêuticas – PCDTs), while pharmaceutical assistance is organised into basic, strategic and specialised components aligned with disease priorities and budget considerations. *Legal Disclaimer: This document has been reviewed with the assistance of Harvey AI for the purposes of grammar correctness, typographical error identifi - cation and standardisation of terms and definitions throughout. All substantive content, analysis and con- clusions remain the sole work product of the authors.
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