Ministry of Health establishes Committee to negotiate confidential prices
In brief
On July 23, 2026, Ordinance GM/MS No. 12,011/2026 (the “Ordinance”) was published, establishing, within the Ministry of Health (the “MoH”), the Committee for the Negotiation of Prices and Economic Conditions of Health Technologies (the “Committee”), a permanent collegiate body of a technical, advisory, negotiating, and deliberative nature intended to support, coordinate, and conduct, on a supplementary basis, the negotiation of prices and other economic conditions applicable to health technologies submitted for assessment for incorporation into the Unified Health System (the “SUS”) or that are the subject of MoH procurements. The Ordinance also sets out the requirements for negotiations involving the restriction of access to information regarding the price actually paid (“confidential prices”), particularly in the procurement of high-cost technologies. The Ordinance became effective on the date of its publication.
In more detail
The Committee’s action will take priority in cases involving a sole supplier, concentrated markets, or situations of significant budgetary impact, covering both (i) procurement processes under the MoH’s responsibility and (ii) health technologies submitted for assessment by the National Commission for the Incorporation of Technologies into the SUS (“Conitec”) within the scope of the incorporation process. The Committee is also responsible for proposing negotiation strategies aimed at broadening access and ensuring the economic sustainability of public health policies; negotiating economic and operational conditions to be submitted to the competent units for possible formalization in contractual instruments, which may include managed entry agreements, risk-sharing arrangements, conditional discounts, or other legally permissible mechanisms; and recommending to the competent authority, on a specific and substantiated basis, the adoption of measures to restrict access to information or, where the legal requirements are met, the classification of information produced or obtained in the course of the negotiation.
The Committee will act upon request from (i) the MoH Department responsible for the policy or program related to the clinical condition, in the case of a technology already incorporated into the SUS that has shown a significant and duly demonstrated increase in its budgetary impact, or where monitoring indicates the need for negotiation prior to procurement or for the renegotiation of prices or other economic conditions of a contract under performance, where legally permissible and subject to the powers of the responsible units and authorities; or (ii) Conitec, within the scope of horizon scanning or during the assessment process, in cases involving high-cost technologies or technologies with a high budgetary impact.
As to its composition, the Committee will be made up of two representatives of the MoH Executive Secretariat, one of whom will act as coordinator, and two representatives of the MoH Department of Science, Technology, and Innovation (“SCTIE/MoH”), each with a respective alternate. An ad hoc member will also join the collegiate body, exclusively for the corresponding negotiation, namely a representative of the Department responsible for the health policy, program, or action related to the technology under negotiation, whose participation and count for quorum purposes will be limited to the deliberations relating to the respective technology.
In the negotiations, the Committee will invite the marketing authorization holder or, where applicable, the company responsible for the commercialization or supply of the technology to present its commercial proposal and, where available, information on prices and economic conditions applied in the international market.
Should the company fail to submit a proposal or the necessary information, the Committee may formulate a counterproposal or a price recommendation based on market research, national and international references, public databases, and other reliable sources, including prices in national public procurement, international markets, official databases, MoH technical studies, and parameters from international bodies or foreign regulatory authorities. Based on the available information, the Committee will define the strategy and mechanism to be used in the negotiation, submitting to the competent units the conditions that require contractual formalization. The elements produced by the Committee may be used to support the procurement process, without replacing the estimate of the contract value, the price justification, and the other acts assigned to the competent units and authorities. The negotiation meeting will be recorded in minutes and filed in the relevant proceedings, subject to the restriction scenarios provided for by law.
In the procurement of high-cost health technologies, the negotiation of a confidentiality clause and the recommendation to restrict access to information regarding the price actually paid will depend on the cumulative demonstration of the following requirements: (i) contracting through a waiver of bidding, based on the unfeasibility of competition arising from the existence of a sole supplier, under the terms of article 74 of Law No. 14,133/2021; (ii) the strategic relevance of the technology for the implementation of public health policies and for the sustainability of the SUS; (iii) demonstration of a concrete risk of harm to the State’s negotiating position resulting from the disclosure of the economic conditions, particularly in view of international price-referencing practices; (iv) the economic and health-related relevance of the technology; and (v) a substantiated technical justification for the need for the restriction. Any restriction will be limited to information that would allow the price actually paid to be inferred, except where an autonomous legal basis exists for the protection of other information.
The Committee may recommend to the competent authority the restriction of access to information regarding the price actually paid or, where the respective legal requirements are met, its classification at a level of secrecy, with the recommendation being forwarded to the competent authority for decision. The recommendation must define, at a minimum, the information subject to access restriction, the public officials authorized to access it, the term or condition for reassessing the restriction, the measures necessary to protect information classified as commercially or competitively sensitive, and the reasoning demonstrating the adequacy, necessity, and proportionality of the measure. Where commercial confidentiality mechanisms are adopted, the net prices negotiated, the discounts granted, rebates, bonuses, and other agreed economic conditions may be subject to access restriction or classification.
In cases of action requested by Conitec, the recommendation to formalize negotiated economic conditions involving the restriction of access to price information will be conditioned upon the cumulative fulfillment of: (i) a price consistent with the cost-effectiveness thresholds and with the cost-effective price range informed by Conitec; (ii) a budgetary impact consistent with the budget appropriation of the responsible area for the following year; and (iii) advantageousness in relation to prices applied in other markets or to other reference prices. The Committee will inform the Conitec Executive Secretariat, prior to the final recommendation, whether or not these parameters have been met, preserving, wherever possible, the information whose access restriction has been duly established.
Finally, the term for concluding the negotiation and approving the corresponding recommendation or report by the Committee will be thirty days, counted from the receipt by the Committee’s Executive Secretariat of the duly prepared request, extendable once for up to fifteen days upon justification, with the term being suspended during the period granted to the requesting unit to supplement the case file.
