Regulation of Doctor-Industry relations by the Federal Council of Medicine
Relations between the medical community and the healthcare industry in Brazil will experience a major shift in 2025.
On March 1st, 2025, the Resolution of the Brazilian Federal Council of Medicine (“CFM”) No. 2,386/2024 (“Resolution”) will come into force, establishing rules applicable to doctors’ links with pharmaceutical, health care supplies and medical equipment industries.
The Resolution does not create specific obligations for the industry but introduces changes to increase the transparency of relations between doctors and industry and prevent these links from affecting the health system.
According to the Resolution, this relationship is characterized when the doctor:
- Is formally hired to work in a business-related occupation;
- Provides occasional and/or paid service;
- Carries out or takes part in product development research;
- Is invited or hired for a fee to promote a product;
- Is hired to be a speaker; and
- Is a member of the National Commission for the Incorporation of Technologies into the Unified Health System (“Conitec”) and/or similar deliberative councils such as the National Supplementary Health Agency (“ANS”), the National Health Surveillance Agency (“Anvisa”) and others.
In these cases, doctors must declare their links on the “CRM-Virtual” page of the Regional Council of Medicine in which they have active registration, within 60 days of receiving the benefit. The doctor must also report any termination of relationship on the same page.
In interviews, debates or any exposure to the general public regarding medicine and at medical events, the doctor must also disclose the existence of the relationship and declare any conflict of interest.
The Resolution clarifies that the link will not be characterized by (i) receiving income and dividends from investments in shares and/or quotas in companies and (ii) offering free samples of medicines and/or products received from companies. In these cases, there is no need for any declaration by the doctors.
When announcing the Resolution, the CFM said that “doctors who fail to comply with the requirements of the resolution may be subject to sanctions by the Regional Councils”.
Regulation of the relationship between doctors and industry began in the United States in 2010 with the Physician Payments Sunshine Act, which obliges companies in the healthcare industry to report payments to doctors and teaching hospitals. The law became a global benchmark and, since then, regulation has spread to other countries.
In Brazil, the first regulation of the issue came from State Law No. 22.440/2016, of the state of Minas Gerais. The law requires companies to declare to the State Health Department any benefits offered to health professionals registered with the state’s councils. The declarations are published by the Department with information such as date, value and object, allowing any interested party to monitor relations between doctors and industry.
There are legislative initiatives with the same objective in the National Congress – such as Bills 7.990/2017, 11.050/2018 and 11.177/2018 – which could be added to the Resolution. Unlike the Resolution – since the CFM is only competent to regulate the practice of the medical profession –, these bills are focused on obligations for the industry, such as the requirement to disclose all benefits granted to doctors on their websites.
This bulletin is for information purposes only and should not be relied upon to obtain legal advice on any of the topics dealt with here. For additional information, please contact the leaders of the Compliance and Anti-Corruption Team.
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