New CFM resolution: Physicians must report on partnerships with pharmaceutical companies, health, and medical equipment suppliers

On September 02, 2024, CFM Resolution No. 2,386/2024 was published, which regulates the procedures and regulations for partnerships between physicians and pharmaceutical manufacturers, health, and medical equipment suppliers, and intermediaries to comply with the laws and ethical regulations that the Brazilian Federal Council of Medicine (“CFM”) published. The new resolution aims to increase transparency and prevent conflicts of interest that can influence clinical decisions.

• Physicians’ obligation to report on partnerships
  1. Physicians that have established partnerships with pharmaceutical companies, health, and medical equipment suppliers, or intermediaries must include these company names on CFM’s Regional Council of Medicine – Virtual System (“CRM-Virtual”), which is an exclusive digital platform designed for this professional category.
  2. Physicians must notify the CFM about partnership terminations.

• Identifying partnerships
  1. Formal contracts for occupations involving the type of companies mentioned above.
  2. Provision of occasional and/or remunerated services.
  3. Participation in research and development of pharmaceutical products, materials, or medical equipment.
  4. Paid publication (guest or hired).
  5. Members of the Brazilian Committee for Health Technology Incorporation (“CONITEC”) and similar deliberative councils, such as the Brazilian Supplementary Healthcare Agency (“ANS”), and the Brazilian Health Regulatory Agency (“ANVISA”), among others.
  6. Speakers.

• Publishing conflicts of interest

After reporting on partnerships on CRM-Virtual, conflicts of interest will be published on CFM’s platform. Publishing conflicts of interest aims to ensure transparency and integrity in medical practice. By disclosing said information, the CFM ensures that patients and society at large are aware of possible external influences affecting healthcare professionals’ bias and ethics.

• Ban on benefits

Physicians must not receive benefits involving medicines, orthoses, prostheses, special materials, and hospital equipment without previous marketing authorization from ANVISA, except for approved research protocols.

• Reporting on conflicts of interest

Physicians must report on any conflict of interest in interviews, debates, public exhibitions, and medical events.

• Exceptions
  1. Income and dividends from investments in equity shares and/or quotas.
  2. Free samples of medicines and/or products.
  3. Benefits received by scientific companies and medical entities.

• Penalties

The new resolution does not specify the applicable penalties if physicians fail to comply with the new obligations. The CFM only states that “[…] physicians who fail to comply with the requirements under the resolution may be subject to sanctions by the Local Medicine Councils (“CRMs”)”.

• Term

The resolution enters into force 180 days after its publication date (September 02, 2024). During this period, professionals must review their partnerships to ensure that any appropriate information is recorded correctly. Physicians who already have partnerships with healthcare companies will have 60 days, after the resolution has come into force, to report on benefits received.

Demarest’s Life Sciences team is monitoring the updates on this topic and remains available to provide any further clarifications that may be necessary.