No. 193

Federal Official Gazette

Ordinance GM/MS No. 12,011, of July 22, 2026

Establishes, within the Ministry of Health, the Committee for the Negotiation of Prices and Economic Conditions of Health Technologies and provides for its organization, operation and the negotiation of economic conditions applicable to health technologies.

Observation: Ordinance GM/MS No. 12,011/2026 establishes, within the Ministry of Health, the Committee for the Negotiation of Prices and Economic Conditions of Health Technologies. The collegiate body will have the function of supporting and conducting negotiations relating both to technologies submitted for assessment for incorporation into SUS and to procurement carried out by the Ministry itself, with priority for products from sole suppliers, concentrated markets and technologies with a high budgetary impact. The mechanisms allowed include managed access agreements, risk sharing, conditional discounts, rebates and other forms of economic negotiation.

The Ordinance also governs the use of national and international price information and sets conditions for the adoption of confidentiality clauses. In purchases of high-cost technologies, restricting access to the price actually paid will depend, among other requirements, on the supplier’s exclusivity, the strategic relevance of the technology and a showing that disclosure could harm the State’s negotiating position. The measure therefore seeks to increase SUS’s negotiating power, especially with respect to medicines and other innovative technologies marketed in poorly competitive structures.

There is no direct normative impact on health plan operators or on the processes for incorporation into the ANS List of Health Procedures and Events (Rol). The possible effects on supplementary health are indirect: the negotiations conducted by the Ministry of Health may influence manufacturers’ commercial strategies, widen the differences between public and private prices and make it harder to use the price paid by SUS as a reference in private contracting, especially where confidential discounts apply. At the same time, the institutionalization of risk-sharing and managed access agreements in the public sector could strengthen the debate on adopting similar mechanisms in supplementary health, especially for high-cost technologies with a high budgetary impact.

EXTRACT OF UNDERTAKING

Type: Term of Undertaking (Termo de Compromisso). Administrative proceeding: 33910.020559/2026-90. Obligee: Agência Nacional de Saúde Suplementar (ANS) – CNPJ 03.589.068/0001-46. Undertaking parties: Unimed do Estado do Rio de Janeiro – Federação Estadual das Cooperativas Médicas – CNPJ 31.432.792/0001-05 and Unimed do Brasil Confederação Nacional das Cooperativas Médicas – CNPJ 48.090.146/0001-00. Purpose: to ensure continuity of care for the beneficiaries of Unimed do Estado do Rio de Janeiro – Federação Estadual das Cooperativas Médicas, whose care risk was shared with Unimed do Brasil Confederação Nacional das Cooperativas Médicas, so that all conditions specified in the respective clauses are fulfilled, in order to allow the care-related and economic-financial rebalancing of the portfolio. Date of Signature: Jul 14, 2026. Term: 24 (twenty-four) months. Signatories: Wadih Nemer Damous Filho – Chief Executive Director (Diretor Presidente) of ANS; João Alberto da Cruz – Legal representative of Unimed do Estado do Rio de Janeiro – Federação Estadual das Cooperativas Médicas, and Omar Abujamra Junior – Legal representative of Unimed do Brasil Confederação Nacional das Cooperativas Médicas.