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On September 2, 2024, the Brazilian Federal Medical Board (CFM) issued Rule #2,386, establishing guidelines for relationships between physicians and the pharmaceutical and medical devices companies. As explained by CFM's Reporting Commissioner, Raphael Parente, the rule aims to promote ethical conduct while preserving physician autonomy and patient well-being. The rule addresses concerns about the potential influence of marketing on physician prescribing practices.

The potential for conflicts of interest between healthcare professionals and the pharmaceutical and medical devices companies has been a longstanding concern worldwide. The first legislation to address such concern was the U.S. Physician Payments Sunshine Act, enacted in 2010. Later, the European Union's Disclosure Code have also served as model for similar regulations in other countries, such as France, Slovakia, Portugal, Greece, Denmark.

In Brazil, while there is no federal legislation yet¹, the State of Minas Gerais has taken the lead with the enactment of Law #22,440/2016 and Law #22,291/2018. These laws require pharmaceutical and medical devices companies to disclose their relationships with healthcare professionals, including sponsorships for scientific events. Additionally, the CFM’s Code of Ethics includes a general provision requiring physicians to declare potential conflicts of interest arising from company’s relationships (Article 109). Industry self-regulation efforts have also contributed to a more transparent environment.

CFM’s Rule #2.386/2024 was issued in this context. The rule mandates that physicians disclose their relationships with pharmaceutical and medical devices companies on the website of the State Medical Board (CRM) in which they are registered in the specific situations listed in Article 3. These situations include membership in regulatory bodies like the National Regulatory Agency for Private Health Insurance (ANS) or the Brazilian Food and Drug Agency (ANVISA), formal employment or contract work, participation in research or product development, and serving as paid speakers at industry events. The rule does not require disclosure of travel and accommodation expenses received by physicians solely for attending industry events.

As per the CFM’s Rule #2.386/2024 wording, the information to be disclosed is limited to the names of the companies for which the physicians provide services and the duration of these connections. Thus, in theory, the rule does not require disclosure of the financial amounts received by physicians. Rule #2.386/2024 differs from the Minas Gerais state legislation in such aspect, since the state legislation requires companies to disclose the amounts of all donations and payments made to healthcare professionals. Another key difference is that the state legislation places the obligation to disclose on companies, whereas CFM's rule places the onus on physicians.

It is important to mention that Rule #2,386/2024 does not provide specific guidance on the level of detail that must be disclosed. Thus, considering that CRMs have not yet made available on their websites the specific platforms and forms for physicians to comply with their obligations, it will still be important to see how this dynamic will work.

Physicians must disclose their relationships with the companies within 60 days of receiving any benefits or considerations. This information will be made publicly available on CFM`s website. Already existing connections must also be disclosed within 60 days of the rule's effective date. Additionally, physicians must declare these conflicts when participating in media interviews, public debates, or medical events (an obligation that was already imposed by CFM Rule #2,336/2023 on medical advertising and propaganda).

One aspect that stands out is that Rule #2,386/2024 presumes that any physician-industry connection listed in Article 3 creates a conflict of interest, regardless of the specific circumstances (e.g., the scope of the services provided). In other words, it is not up to the physician to make an assessment as to whether a conflict actually exists.

Finally, Rule #2,386/2024 does not prescribe specific penalties for non-compliance with its disclosure requirements. Instead, it refers to the general need for compliance with the laws and ethical standards issued by the CFM. This means that, in theory, penalties imposed may range from a simple warning to revocation of professional practice, depending on the severity of the violation (as provided for in article 22, paragraph 1, of Law #3,268/1957), which is highly debatable from the legal standpoint.

Upon the publication of Rule #2,386/2024, concerns arose regarding its potential conflicts with the requirements for data processing provided for in General Data Protection Law (Law #13,709/2018 - LGPD). One key area of concern was the requirement to obtain consent from physicians. However, a closer analysis suggests that compliance with the LGPD should not be a problem at least in this sense. Although obtaining the data subject's consent is the most common hypothesis for allowing data processing, it is not the only one. The LGPD's exception for data processing necessary to comply with a legal or regulatory obligation, provided for in Article 7, item II, allows for the disclosure requirements of Rule #2,386/2024 without requiring explicit consent from physicians.

CFM Rule #2,386/2024 will come into effect on March 1, 2025.