The Brazilian Federal Council of Medicine (CFM) published, on September 2nd, Resolution No. 2,386/2024, which establishes new rules and procedures for the disclosure and publicity of affiliations between physicians and healthcare companies, including pharmaceutical firms, manufacturers, and distributors of medical supplies and devices.
The primary goal of this resolution is to promote transparency in the relationship between physicians and healthcare industries, safeguarding the interests of patients and society.
The CFM emphasized the importance of physicians disclosing conflicts of interest when participating in interviews, debates, or public discussions related to healthcare matters. The resolution aims to provide greater clarity to the public by recognizing the influence of marketing on the relationship between healthcare professionals, industry players, and patients. Inspired by U.S. legislation known as the “Sunshine Act,” the new regulation places transparency at its core, ensuring that medical advice remains focused on delivering the highest standard of care for patients.
Obligation to disclose affiliations
Physicians who maintain affiliations with healthcare companies are required to disclose these relationships in a specific section that will be made available on the Virtual CRM platform of the Regional Council of Medicine where they are registered. Additionally, they must notify the Council when such affiliations are terminated. The resolution provides details on the types of affiliations that must be disclosed:
- Formal employment by healthcare companies;
- Occasional or paid service provision;
- Participation in research or the development of medical products;
- Promotion of products for remuneration;
- Membership in committees and councils such as the National Commission for the Incorporation of Technologies in the Unified Health System (Conitec), the National Health Agency (ANS), the National Health Surveillance Agency (Anvisa), and others; and
- Paid engagements as speakers.
It is important to note that existing affiliations must be reported within 60 (sixty) days of the relationship’s establishment and will be published on the CFM’s designated platform..
Exemptions from disclosure obligations
Resolution No. 2,386/2024 excludes certain earnings from the disclosure obligation, such as those derived from investments in shares or equity in healthcare companies, as these are considered financial investments with no direct operational link to the companies. Additionally, the receipt of free medication samples for patient treatment and benefits received from scientific societies and medical entities, such as sponsorships and grants intended for scientific and professional development, do not need to be disclosed.
Disclosure of conflicts of interest in public events
Resolution No. 2,386/2024 will come into effect on March 1, 2025, when all its obligations will become enforceable. Until that date, physicians must comply with the new disclosure requirements, and healthcare companies should assess the risks related to potential conflicts of interest that could affect their operations. Should any questions or need for guidance arise, KLA has a team of experts available to assist both in risk assessments and in adapting to the requirements of the new regulation.
For further information, contact the Compliance team.
