Controversial Authorization: Council asserts that biomedical professionals are able to prescribe cannabis, but Anvisa questions competence

By João Negromonte

A decision by the Federal Council of Biomedicine (CFBM), allowing biomedical professionals to prescribe cannabis derivatives, published in the Official Gazette of the Union last month, has sparked debates and disagreements with the resolutions of the National Health Surveillance Agency (Anvisa). While the CFBM sees the measure as a significant advancement in the field of health, offering new therapeutic possibilities for patients seeking natural alternatives, Anvisa disputes this authorization, reinforcing its competence in the control and monitoring of cannabis derivatives.

According to the resolution published by the CFBM, the use of herbal products based on cannabidiol can be carried out by biomedical professionals qualified in Traditional Chinese Medicine/Acupuncture. The decision is supported by literature and Eastern tradition, which mentions the analgesic properties of herbal products based on cannabis. The CFBM emphasizes the importance of biomedical professionals having in-depth training and knowledge about the safe and effective use of the substance, as well as following dosage criteria, taking into account the specific needs of each patient.

When asked if the authorization for the inclusion of biomedical professionals in the prescription of cannabis derivatives came through regulation with Anvisa, the Council stated in a note to the Sechat portal:

“The Council is the autarchy responsible for determining the professional scope of practice. There was no interference from Anvisa. In RDC No. 660, of March 30, 2022, the health agency's article 1 establishes the criteria and procedures for cannabis-derived products through “prescription by a professional legally qualified for health treatment,” the note highlights.

The note further emphasizes that: “According to Anvisa itself, it is the responsibility of professional councils to regulate professional practice and the incorporation of new technologies and therapies, based on scientific evidence, through research and studies that demonstrate the effectiveness and safety of these products. Thus, once the practice, procedure, or therapy is recognized by competent bodies, it will be up to the agency to regulate and oversee compliance with the sanitary criteria to be followed.”

On the other hand, Anvisa contradicts the decision, arguing that the cannabis plant species is expressly listed in Annex I of RDC No. 26, 2014, which deals with the "list of species that cannot be used in the composition of traditional herbal products." Additionally, Anvisa clarifies that cannabidiol is considered a phytopharmaceutical, not an herbal product or a product of Traditional Chinese Medicine, as per RDC No. 24, 2011.

In a note to the Sechat portal, the agency emphasizes that the control and dispensing of cannabis-derived products are subject to the requirements established in Ordinance SVS/MS No. 344 of 1998, which directs the prescription of special control medications only to physicians or dentists.

For the Council, in the event that Anvisa does not allow the prescription of biomedical professionals in cannabinoid therapy, the recourse may be through the courts:

“It is not within the scope of Anvisa to allow prescription by biomedical professionals, so if there is any kind of litigation, we will defend the activity, as happened in physiotherapy and nutrition, which won a legal case allowing prescription,” the note also states.

Faced with this situation, more in-depth debates and revisions in regulations may occur to clearly and consensually define the criteria for prescribing cannabis-derived products.

It is important that the interests of patients, the safety and effectiveness of treatments are considered, seeking a balance between access to innovative therapeutic alternatives and ensuring adequate supervision by qualified healthcare professionals.