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Limits of CMED’s Regulatory Intervention in Sales Resulting from Judicial Claims

The Chamber for the Regulation of the Pharmaceutical Market (CMED) launched, on January 8, 2026, Public Consultation No. 1/2026, an initiative that forms part of the set of measures adopted following the judgment by the Supreme Federal Court of Brazil in Theme 1234, whose objective includes the establishment of pricing parameters for purchases of medicines resulting from judicial decisions. The proposal was justified on the basis of the absence of clear parameters for price formation in judicial acquisitions, a regulatory gap that would be contributing to significant economic distortions in public health policy, including substantial price variations among different acquisitions of the same medicine.

The deadline initially established for the submission of contributions was 60 days, beginning on January 15, 2026. Subsequently, through Order No. 1, dated March 9, 2026, the deadline was extended for an additional 30 days, expanding the period for public participation, which will end on April 15, 2026.

Despite the relevance of the matter, the proposed regulation raises questions from a legal and regulatory perspective, since some of its elements indicate possible tensions with the framework currently established under the Brazilian legal system.

A first axis of analysis concerns the institutional limits of CMED’s activities. The Brazilian legal framework already provides for an instrument aimed at controlling prices in sales to the government: the Maximum Government Sale Price (PMVG). This model, arising from Law No. 10,742/2003, established the economic regulation regime for the sector, granting CMED powers primarily related to the regulation of medicine prices.

The proposal submitted for public consultation, however, expands the scope of such regulatory authority by introducing additional mechanisms for price compression. In practice, the measure creates a new layer of economic intervention over an exceptional form of contracting. From this perspective, the proposed model raises questions regarding the compatibility of such sub-legal initiative with the legal framework established by Law No. 10,742/2003.

Furthermore, the uniform regulatory treatment being afforded to operations of substantially different natures warrants reflection. The proposed regulation is based on the assumption that sales carried out in compliance with judicial decisions could be regulated according to parameters applicable to ordinary public procurement, disregarding their particularities.

In traditional public procurement arrangements, the public administration operates within a structured environment characterized by prior demand planning and the establishment of stable contractual conditions. Such arrangement allows suppliers to organize their supply chains more efficiently and creates conditions for competitive processes capable of generating economies of scale.

Acquisitions resulting from judicial decisions, in turn, are marked by the urgency of satisfying individual needs and by the absence of prior planning. Supply frequently occurs within reduced deadlines, without demand forecasting and through isolated requests. This environment of uncertainty directly impacts the cost structure, as unpredictability may increase administrative, operational and financial costs.

In this context, it is also relevant to examine the possible impacts of the measure on the supply of certain medicines. The intensification of price compression mechanisms may significantly alter the economic conditions that make this type of supply feasible for segments of the pharmaceutical market characterized by technological complexity or by more concentrated supply structures, such as high-cost medicines, imported products or therapies for rare diseases. In such cases, dependence on complex production chains and on a limited number of manufacturers/distributors means that interventions significantly affecting the remuneration associated with supply may reduce the economic attractiveness of such operations and potentially impact the availability of these products.

From a broader perspective, the proposal also raises reflections regarding its potential indirect impacts on the dynamics of innovation and access to new technologies. In markets characterized by high investments in research and development, predictability regarding commercialization conditions constitutes a relevant factor for strategic decisions concerning the entry and permanence of products in the market. Thus, regulatory measures aimed exclusively at reducing public expenditures in the short term may produce counterproductive effects in the medium and long term, such as a reduction in the number of suppliers and, ultimately, impacts on access to innovative or highly complex therapies.

Even so, the proposal reveals important challenges for its implementation. Among them are the need to more precisely define the boundaries of CMED’s activities, as well as the importance of considering the economic and operational specificities of sales resulting from judicial decisions and the possible impacts on the pharmaceutical market. In this context, the effectiveness of any regulatory intervention will depend on the development of a regulatory model capable of reconciling economic regulation and institutional flexibility, balancing the sustainability of public health policies with the preservation of a stable regulatory environment that ensures the continuous supply of medicines to the public sector and the population’s access to essential therapies and innovative technologies.