South America: Food, Drugs, Healthcare, Life Sciences

Brazil's new Statute #15,471 elevates the National Health Strategy for the Health Economic-Industrial Complex to statutory level, transforming a government program into a State program while introducing significant changes to Product Development Partnerships, procurement processes, and technology transfer requirements.

Eduardo Hallak, founding partner of Licks Attorneys in Brazil, delivered a comprehensive analysis of Brazil's medical device market structure, regulatory framework, and patent protection system at the 6th IP Forefront Medical Device Forum. The presentation explored strategic pathways for Chinese medical device companies to enter the Brazilian market, including Product Development Partnerships, ANVISA regulatory compliance, and patent portfolio optimization within Latin America's largest healthcare market.

México prohíbe el uso del colorante Eritrosina (Rojo 3 FD&C) en alimentos, bebidas y suplementos alimenticios a partir de mayo de 2026. Los fabricantes disponen de 24 meses para reformular productos que contengan este aditivo y agotar existencias, afectando categorías como helados, lácteos saborizados, bebidas no alcohólicas, productos de panificación y licores.

Brazil's new Statute #15,471 elevates the National Health Strategy for the Health Economic-Industrial Complex to statutory level, transforming a government program into a State program while introducing significant changes to Product Development Partnerships, procurement processes, and technology transfer requirements.

A Resolução CFM 2.460/2026 proíbe expressamente cashback, comissões e repasses vinculados a plantões ou indicações médicas, estabelecendo sanções que alcançam toda a cadeia de saúde. A norma detalha práticas vedadas e amplia a responsabilização para intermediários, gestores e até estruturas jurídicas que facilitem tais arranjos.

Brazil's Life Sciences legal landscape is undergoing significant transformation through regulatory consolidation, pricing reforms, and evolving IP frameworks. Recent Supreme Court decisions on patent extensions and healthcare judicialization, combined with stricter CMED pricing controls, are reshaping market access strategies and creating both challenges and opportunities for pharmaceutical and biotech companies operating in this complex regulatory environment.

Brazil's patent office has revised its examination guidelines for new use inventions in chemistry, particularly medical uses, following extensive stakeholder consultation. The updated rules now permit post-filing data under certain conditions while maintaining restrictions on dosage regimen and patient group claims, creating a mixed landscape for pharmaceutical patent protection in Latin America's largest market.

Brazil's Life Sciences legal landscape is undergoing significant transformation through regulatory consolidation, pricing reforms, and evolving IP frameworks. Recent Supreme Court decisions on patent extensions and healthcare judicialization, combined with stricter CMED pricing controls, are reshaping market access strategies and creating both challenges and opportunities for pharmaceutical and biotech companies operating in this complex regulatory environment.

Brazil has officially promulgated the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for Patent Procedures through Decree #13,011/2026.