Brazil: Healthcare

Biocon Limited has partnered with Brazilian companies Bahiafarma and Bionovis to secure an exclusive ten-year supply contract for its pertuzumab biosimilar in Brazil's public healthcare market. The partnership aims to improve access to this HER2-positive breast cancer treatment while reducing costs and developing Brazil's domestic pharmaceutical manufacturing capabilities through phased localization.

A Lei nº 15.471/2026 institui a Ensceis, transformando o poder de compra do SUS em instrumento de política industrial para reduzir a dependência produtiva e tecnológica do Brasil em saúde. O KLA preparou um e-book detalhando os principais impactos da nova estratégia nacional, incluindo credenciamento de empresas estratégicas, produtos prioritários e parcerias de transferência de tecnologia.

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The Brazilian Federal Council of Medicine has issued Resolution CFM No. 2,462/2026, establishing administrative measures against legal entities that fail to remunerate physicians for services rendered. This regulation expands the supervisory power of Medical Councils and introduces significant compliance obligations for hospitals, cooperatives, social organizations, and other entities involved in contracting or intermediating medical services, with penalties ranging from warnings to registration cancellatio

Explore the key regulatory updates from May 2026 affecting Brazil's healthcare and pharmaceutical sectors, including new rules for clinical research, drug pricing mechanisms, supplemental health insurance adjustments...

A nova Lei nº 15.378/2026 institui o Estatuto dos Direitos do Paciente no Brasil, reconhecendo formalmente as Diretivas Antecipadas de Vontade (Testamento Vital) e conferindo segurança jurídica às decisões sobre tratamentos médicos em situações de incapacidade futura. O instrumento permite que pessoas capazes manifestem previamente sua vontade quanto aos cuidados de saúde desejados, estabelecendo diretrizes vinculantes para profissionais e familiares.

The new Federal Council of Medicine resolution introduces updated procedures for declaring professional relationships, aiming to enhance transparency and safeguard the interests of patients and society...

Em 12 de agosto, a Agência Nacional de Vigilância Sanitária (ANVISA) iniciou a Tomada Pública de Subsídios – TPS nº 9, com o objetivo de coletar contribuições de interessados...

Stakeholders can submit contributions until October 11 to help build an experimental regulatory environment aimed at fostering innovation and adapting sanitary regulations...