The new Federal Council of Medicine resolution introduces updated procedures for declaring professional relationships, aiming to enhance transparency and safeguard the interests of patients and society
The Federal Council of Medicine (CFM) published The Federal Council of Medicine (CFM) published Resolution No. 2,386/2024 on September 2, which establishes new rules and procedures for the declaration and publicity of relationships between doctors and healthcare companies, including pharmaceutical companies, manufacturers, and distributors of medical supplies and devices.
The resolution's primary objective is to promote transparency in the relationship between doctors and industries, protecting the interests of patients and society.
CFM emphasized the importance of doctors declaring conflicts of interest when participating in interviews, debates, or public presentations on medical topics. The resolution aims to provide greater clarity to the public by recognizing the impact of marketing on the relationship between healthcare professionals, industry sectors, and patients. Inspired by the U.S. legislation known as the "Sunshine Act," the new standard focuses on transparency as a central element, aiming to maintain ethical medical guidelines geared toward providing the best possible care to patients.
Obligation to Declare Relationships
Doctors who have relationships with healthcare companies must report these connections in a specific area on the CRM-Virtual platform of the Regional Council of Medicine where they are registered. Additionally, they must notify the Council when the relationship ends. The resolution details the types of relationships covered:
- Formal employment by healthcare companies;
- Occasional or paid services;
- Participation in research or development of medical products;
- Promotion of products for payment;
- Participation in committees and councils such as the National Committee for Incorporation of Technologies into the Unified Health System (Conitec), ANS, Anvisa, and others; and
- Paid speakers or lecturers.
Existing relationships must be reported within 60 days of the establishment of the relationship and will be published on a CFM platform.
Exemptions from Disclosure
Resolution No. 2,386/2024 excludes from the declaration obligation income from investments in shares or quotas of healthcare companies, as these are financial investments without a direct connection to the operations of these companies. Also excluded are the receipt of free samples of medicines for patient treatment and benefits received from scientific societies and medical entities, such as sponsorships and grants, aimed at scientific and professional development.
Declaration of Conflicts of Interest in Public Events
Resolution No. 2,386/2024 will come into effect on March 1st, 2025, at which point all its obligations will become enforceable. Until then, doctors should comply with the new disclosure requirements, and healthcare companies should assess the risks related to potential conflicts of interest that may impact their operations. If questions or the need for guidance arise, KLA has a team of specialists available to support both risk assessment and adaptation to the new requirements.
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