Brasília – The Health Committee of Brazil’s House of Representatives passed, on Wednesday (15), the substitute text presented by Representative Rafael Simões (UNIÃO-MG) to Bill 667/2021, establishing Managed Access Agreements (Acordos de Acesso Gerenciado – AAGs) as instruments for the acquisition and incorporation of health technologies in the Unified Health System (SUS).

Sponsored by Representative Eduardo da Fonte (PP-PE), the original proposal introduced the concept of Risk-Sharing Agreements (Acordos de Compartilhamento de Risco – ACRs), allowing the Ministry of Health to partner with pharmaceutical companies to incorporate innovative medicines and treatments even amid uncertainties about cost-effectiveness and budget impact.

The substitute text maintains the bill’s main purpose but updates its framework to align with international best practices in health technology management. The AAG model authorizes the Executive Branch to sign contracts with companies holding Anvisa registrations, linking payment to demonstrated clinical and economic outcomes.

Among the main adjustments, the rapporteur removed a clause that tied public procurement prices to Conitec’s evaluations to avoid overlap with the Drug Market Regulation Chamber (CMED). He also clarified that private health plan operators may adopt similar mechanisms under private-law agreements.

The new text adds Article 19-X to the Organic Health Law (Law No. 8,080/1990), formally granting the government authority to adopt managed access agreements. According to Simões, the measure strengthens innovation, ensures budgetary predictability, and expands access to high-cost therapies — particularly for patients with rare diseases.

Representative Eduardo da Fonte hailed the passage as a historic milestone for the SUS, while Representative Dr. Ismael Alexandrino (PSD-GO) emphasized the need for dialogue among all healthcare stakeholders to enhance collaboration and long-term sustainability.

Source: NK Consultores

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