BRAZIL Law and Practice Contributed by: Bruna Rocha, Jessica Filka, Juliana Marcondes and Victoria Cristofaro, COSRO
Entry pricing for new products and new presentations is now governed by CMED Resolution No 3/2025, published on 24 December 2025, republished on 30 December 2025, and effective 29 April 2026, after a 120-day transition. This resolution replaces CMED Res- olution No 2/2004 and modernises the methodology, categories and documentation for determining official price ceilings, including an expanded and more robust Pricing Information Document ( Documento Informativo de Preço – DIP) process. Pharmaceutical companies must keep price lists and transactions within PF, PMC, and, where applicable PMVG, maintain required CMED filings and support for DIP submissions, and operation- alise public sector sales in accordance with govern- ment pricing rules and documentation practices. Medical devices and IVDs are not subject to a nation- wide CMED-style price cap regime. Device pricing is primarily market-based and contract-driven, although public procurement, reimbursement, transparency initi- atives and competition law influence market behaviour. 8.2 Price Levels of Pharmaceuticals or Medical Devices The price level of a new medicine at launch is largely constrained by international prices due to CMED’s external reference pricing regime. Under CMED Reso- lution No 3/2025, which enters into force on 29 April 2026, the PF for new products and new presentations is defined through a category-based assessment sup- ported by a DIP. As a general rule, the PF proposed for Brazil may not exceed the lowest PF observed for the same product in a basket of 14 reference coun- tries (ie, South Africa, Germany, Australia, Canada, Spain, the United States, France, Greece, Italy, Japan, Mexico, Norway, Portugal and the United Kingdom, plus the product’s country of origin where applicable), with Brazil’s applicable taxes added. For a definitive PF, the medicine must ordinarily be commercialised in at least four reference markets with publicly veri- fiable prices; if not, CMED will set a provisional PF and require annual updates until the criterion is met. The resolution codifies currency conversion using the Central Bank’s average selling rate for the prior 60 business days and allows applicants to update the price sought before a first-instance decision where exchange rate movements are significant, which can be material for launch planning.
Category-specific rules continue to respect this international cap while creating structured excep- tions where foreign prices are unavailable – or where incremental innovation, domestic development and manufacturing, or additional therapeutic advantages justify a reasoned departure. These mechanisms are subject to heightened procedural review and do not displace the centrality of external reference pricing in the framework. By contrast, medical devices and IVDs are not subject to a nationwide CMED price cap regime. International prices may influence commercial negotiations, and ANVISA publishes economic monitoring statistics for transparency, but devices are priced through market and procurement dynamics rather than binding exter- nal reference rules. 8.3 Reimbursement From Public Funds Brazil’s SUS finances medicines and medical devices primarily by purchasing and providing them free at the point of care, not by reimbursing patients. Medicines gain the most predictable public funding once formally incorporated through national HTAs led by the Minis- try of Health with CONITEC support. Routine supply is organised through the basic, strategic and specialised pharmaceutical assistance components and reflected in the National Medicines List ( Relação Nacional de Medicamentos Essenciais – RENAME), with routine dispensing through public formularies and stand- ard access lists and higher-cost outpatient therapies accessed under clinical protocols. The Popular Phar- macy Programme ( Farmácia Popular ) complements SUS dispensing by reimbursing accredited private pharmacies to deliver free or subsidised medicines for defined indications. Devices are funded in a procedure- centric, hospital-based model; that is, SUS pays provid- ers for procedures using national coding and payment parameters (Management System for the SUS Table of Procedures, Medicines, and Orthoses, Prostheses, and Special Materials, or Sistema de Gerenciamento da Tabela de Procedimentos, Medicamentos e OPM do SUS – SIGTAP), and hospitals procure implants and special materials within those care packages. Separately, judicialisation has emerged as an increas- ingly prevalent mechanism in Brazil whereby patients petition courts to compel access to medicines and
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