Resolution 2,386/2024 of the CFM aims to regulate the physician-healthcare industry relationship by prioritizing a transparent and trustworthy bond but faces challenges regarding its legality and practical application.

On August 21, 2024, the Federal Council of Medicine (CFM) enacted Resolution No. 2,386/2024, which was approved at a subsequent plenary meeting and published in the Official Gazette of the Union on September 2. The resolution, which will come into effect on March 1, 2025 (Article 8), aims to regulate the relationships between physicians and the healthcare industry (Article 1).

Comprising eight articles, the Resolution has an essentially simplistic nature. It stipulates that any relationship between physicians and industries must be formally declared by the physician to the Regional Council of Medicine (CRM) where they are registered, at both the beginning and end of the relationship (Article 2).

The definition of what constitutes a "relationship" is detailed in Article 3.

Additionally, the regulation prohibits physicians from receiving any benefits related to medicines, orthoses, prostheses, special materials, and hospital equipment not registered with Anvisa, except when these benefits result from research protocols approved by Research Ethics Committees (Article 4). Finally, the resolution requires physicians to declare their conflicts of interest in interviews, debates, and any public exposure, as well as in medical events (Article 6).

Article 5, in turn, presents an apparent narrative flaw: it states that "the information referred to in this article must be provided by the beneficiary within 60 (sixty) days after receiving the benefit," but paradoxically, Article 5 itself does not address any specific content.

Despite its relatively concise approach, the resolution seeks to establish ethical guidelines within a command-and-control system – not surprisingly, conflicts of interest will be disclosed on a dedicated platform by the CFM (sole paragraph of Article 2) – to ensure that the relationships between physicians and the healthcare industry preserve the professional autonomy of the physician and the quality of patient care, as highlighted by the Rapporteur Counselor Raphael Parente.

Although the regulation represents a significant step forward in terms of transparency and integrity, its effectiveness is subject to questioning due to the lack of robust legal backing, as it was enacted by a class council without the necessary legislative basis.

The debate on regulating the relationships between physicians and the healthcare industry is not new in Brazil and involves public policy issues that require legislative attention.

At the state level, for example, Minas Gerais has already addressed the issue through specific laws (Laws 22,440/2016 and 22,921/2018), which require the disclosure of relationships between healthcare professionals and the industry, with the information being published on a state platform.

At the federal level, Bills 204/2019 and 7990/2017, which are currently under consideration in the National Congress, aim to establish a clear and detailed regulatory framework for these relationships. These bills seek to ensure that all financial relationships between physicians and the industry are publicly disclosed, increasing transparency and minimizing conflicts of interest that could harm public health.

Against this backdrop, while CFM Resolution 2,386/2024 aims to promote greater transparency in the relationships between physicians and the healthcare industry, it should be noted that there is no supporting legal norm, casting doubt on its legality, coupled with inherent difficulties in its implementation, such as data protection issues.

The main controversy lies in the authority of class councils, such as the CFM, to impose new obligations on healthcare professionals in the absence of a specific law granting them such authority. Although the Federal Constitution of 1988 has assigned councils the responsibility of regulating and overseeing the practice of the professions they represent, this power must be exercised within the limits established by the existing legislation. In this sense, the imposition of obligations, such as the mandatory declaration of relationships and the prohibition of receiving certain benefits, may be interpreted as a transgression of these limits, potentially infringing the principle of strict legality.

Thus, the discussion regarding the Resolution is not limited to the content of the norm published by the CFM but also focuses on the issue of the normative authority of the council to create and implement such regulations without the proper legal basis approved by the National Congress. In this context, the CFM's attempt to regulate, without legislative support, may be considered an overreach of its regulatory competence.

Indeed, this issue is highlighted by the Rapporteur Counselor of the resolution when he emphasizes the need for regulation of the matter, comparing the Brazilian scenario with other countries that have specific legislation on the subject, underscoring the "Sunshine Act" in the United States, legislation that has become a global benchmark. The similarity between these norms lies in the common objective of increasing transparency and reducing potential conflicts of interest in medical practice. However, CFM Resolution 2,386/2024 arises from a regulatory act of a competent Class Council without any legislative backing, unlike what occurs in the benchmark country. This contrast reveals a significant gap: while internationally recognized legislation relies on a solid legal foundation, the Brazilian resolution still lacks a corresponding legal and legislative foundation.

In this context, there is an imminent concern that the norm may be questioned and even legally challenged, which could lead to its suspension before it comes into effect. There is a pressing need for appropriate regulation, based on broad legislative debate, highlighting the importance of following due legal process to ensure the legitimacy and effectiveness of the norms governing the relationships between physicians and the healthcare industry.

Despite the potential for nullification due to the lack of legal support, CFM Resolution 2,386/2024 should drive the development of pending bills and even the proposal of new ones on the subject, thereby fostering the creation of an effective, robust, and transparent regulatory framework aligned 

with the best international and national anti-corruption practices and capable of ensuring an environment of trust and ethics in medical practice in Brazil.

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This article describes the current thinking at Campos Mello Advogados on these topics and should not be viewed as a legal opinion. 

Campos Mello Advogados is a Brazilian law firm which has worked in cooperation with DLA Piper LLP across the globe since 2010.