BRAZIL Law and Practice Contributed by: Priscila Kashiwabara, Viviane Trojan, Gustavo Vicenti and Giovanna Mezher, Kasznar Leonardos Intellectual Property
actual market prices often fall below set ceil- ings, especially for generics. 8.2 Price Levels of Pharmaceuticals or Medical Devices International reference prices indirectly influence drug pricing in Brazil, particularly in Category I, where they play a significant role. Resolution 2/2004 establishes a price basket compris- ing nine countries, serving as a benchmark for evaluating manufacturer prices, excluding taxes. Category I, for new patented drugs offering sub- stantial benefits, is directly influenced by inter- national prices. The proposed PF cannot exceed the lowest PF practised for the same product in the basket of countries, ensuring competitive market entry. However, drug pricing in Brazil is influenced by factors beyond international prices. • Product characteristics – novelty, therapeutic benefit and patent status influence pricing. • Cost-effectiveness analysis – companies must demonstrate the drug’s cost-effective- ness compared to existing treatments. • Public health needs– CMED may prioritise public health considerations, setting prices below international levels. 8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds Brazil’s healthcare system blends public and pri- vate financing for drugs. Public System (SUS) • SUS prioritises essential healthcare and medication access for citizens.
• SUS is government-funded to ensure univer- sal health access (Article 196 of the Constitu- tion). Drug acquisition: • public bidding – transparent, cost-effective drug procurement via public bidding; • government may purchase patented drugs without bidding; • productive development partnerships – stra- tegic drug partnerships with private firms ensure reliable supply at set prices; and • technology incorporation (CONITEC): (a) evaluates new technology inclusion into SUS based on evidence and cost-effec- tiveness; (b) stakeholder submissions undergo CO- NITEC review and final recommendation; and (c) Law 14,313/2022 allows SUS reim- bursement for off-label drug uses upon CONITEC approval. Private System (Health Insurance) Health insurance coverage: • ANS oversees private health insurance, defin- ing mandatory coverage; and • ANS’s List of Procedures mandates drug cov- erage based on contracted plans. List of procedures: • ANVISA authorisation – only ANVISA- approved drugs are included; and • the list is updated every two years to include new technologies. Judicialisation:
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