Two ordinances issued by the Ministry of Health in July 2026 established new mechanisms to monitor the availability of technologies incorporated into the Unified Health System (SUS) and to negotiate prices and economic terms with their suppliers.
These changes are not limited to so-called high-cost medicines, nor do they concern only companies submitting a new technology to Conitec. Generic products, technologies incorporated years ago, and previously rejected products may require a new assessment, depending on their current status within the SUS and the company’s strategy.
Ordinance GM/MS No. 11,981, dated July 20, 2026, and published on July 22, established a process to monitor the availability of technologies incorporated into the SUS that are funded by the Federal Government.
Following the decision to incorporate a technology, the relevant departments within the Ministry of Health must coordinate the measures necessary to ensure the technology is effectively made available, including:
- definition of funding and provision responsibilities;
- budget forecasting;
- development or updating of clinical guidelines;
- inclusion in or modification of SUS schedules;
- adjustment of infrastructure and care workflows;
- planning and monitoring of centralized procurement, where applicable.
The aim is to narrow the gap between formal incorporation and actual access. A favorable decision by Conitec, in isolation, does not guarantee availability when protocols, budgets, defined responsibilities, care infrastructure, or procurement processes are still lacking.
Ordinance GM/MS No. 12.011/2026, published on July 23, established the Committee for the Negotiation of Prices and Economic Conditions for Health Technologies.
The Committee may operate during Conitec’s technology assessments, during procurement processes carried out by the Ministry of Health, and during the renegotiation of existing contracts. Its work may also help facilitate the acquisition of technologies that have already been incorporated but are not yet available within the SUS.
Mechanisms permitted include:
- managed access agreements;
- risk-sharing;
- conditional discounts;
- staggered purchasing;
- portfolio-based negotiation;
- discounts with confidentiality regarding the actual price paid;
- other economically and legally permissible solutions.
The Committee will not replace Conitec or the units responsible for procurement. The negotiated terms will still require submission to the relevant areas and, where applicable, proper contractual formalization. The Ministry of Health presents the new model as a way to leverage the SUS’s purchasing scale and expand access to medicines, therapies, vaccines, and equipment.