Brasília – Specialists called for greater flexibility in the design of shared-risk agreements between Brazil’s Health Ministry and pharmaceutical companies. These agreements, currently under discussion in the House of Representatives through Bill 667/2021, allow experimental use of treatments that have not yet completed all clinical trial phases.

These contracts aim to share clinical and budgetary risks between the public sector and manufacturers, enabling patient access to advanced therapies — especially for rare diseases or cases where other treatments have failed. Cássio Ide Alves, technical director at Abramge, noted that agreements may include features like volume-based discounts or confidentiality clauses, and in some cases, tying payment to treatment results.

However, Luciene Fontes Schluckebier Bonan, director of Technology Incorporation at the Health Ministry, warned that outcome-based contracts are complex to manage, as they require analyzing multiple individual-level factors — such as whether patients followed clinical follow-up, lifestyle protocols, or rehabilitation — before determining effectiveness and approving payment.

Professor Edimilson Ramos Migowski de Carvalho, from UFRJ, urged inclusion of public universities and official labs in the legislation, highlighting the unfair imbalance in public R&D funding relative to private investment, with R$ 2 billion directed to private entities by BNDES. Antonio Campos from Fiocruz added that technology transfer contracts should be incentivized. He cited a current agreement enabling the local production of CAR-T cell therapy at just one-tenth of the international cost, and another facilitating spinal muscular atrophy treatment at five times lower cost than the international price.

Given the complexity of shared-risk models, rapporteur Congressman Rafael Simões (União-MG) emphasized the need for broad stakeholder engagement — including the health ministry — to develop a viable, executable law. “If we don’t, we create a ‘monster’ and won’t know how to get out of it,” he warned.

Source: Agência Câmara

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