The Federal Council of Medicine (CFM) published this Friday (14) a new rule with rules for the prescription of drugs based on cannabidiol, a derivative of cannabis. According to CFM Resolution 2,324published in the Official Gazette of the Union, the cannabis medicinal product can be prescribed only in the treatment of refractory epilepsy in children and adolescents with Dravet and Lennox-Gastaut syndrome or tuberous sclerosis complex. Other types of epilepsy cannot have cannabidiol prescription for treatment, which excludes adults. 
The rule also prohibits the physician from prescribing the raw cannabis for medicinal use, as well as any derivatives other than cannabidiol. The prescription of cannabidiol for a therapeutic indication other than that provided for in the resolution is prohibited, with the exception of clinical studies previously authorized by the system formed by the National Research Ethics Commission and Research Ethics Councils (CEP/CONEP). Doctors are also prohibited from giving lectures and courses on the use of cannabidiol or products derived from cannabis outside the scientific environment, as well as publicizing it. The resolution must be reviewed within three years from the date of its publication.
In a note published by CFM, counselor Rosylane Rocha, rapporteur of the new resolution, argued that, since the publication of Norm 327 of Anvisa, in 2019, that provides for the manufacture and the import of products with cannabis for medicinal purposes, “there were numerous activities to promote the use of cannabis and a significant increase in the prescription of cannabidiol for diseases to replace conventional and scientifically proven treatments”.
The CFM measure is valid for three years and is the body’s first guidance since 2014. The resolution also determines that the patient undergoing treatment with cannabidiol (or their legal guardians) must be communicated about the problems and potential benefits of the treatment. A Free and Informed Consent Term (TCLE) will have to be presented and signed by the interested parties. In the document, among other points, the patient acknowledges that he was informed about possible treatment options.
reviews
Under the new rules, doctors are prohibited from prescribing drugs based on cannabis for the treatment of chronic pain, pain derived from diseases such as cancer, anxiety, Parkinson’s, autism or Alzheimer’s. The treatment of these types of pathologies with products based on cannabis. although complementary, it has been recommended by doctors in Brazil and in several countries.
For lawyer Gabriel Dutra Pietricovsky, who works in the area of right to health, and advises patients who seek judicial authorizations for the cultivation of cannabis for medicinal purposes, the CFM resolution has more political than scientific connotations and is contrary to the most advanced therapeutic practices internationally.
“A measure of this nature comes to be embarrassing, which is more similar to a political position of the entity, which acts to restrict the development of knowledge. It is going in the opposite direction of the most advanced science in relation to products derived from the cannabis“, he points out. According to the lawyer, the text of the resolution compromises even the treatment of adults with Dravet and Lennox-Gastaut syndrome, since the text only mentions children and adolescents.
According to the CFM, the new resolution was prepared after scientific reviews on the therapeutic applications and safety of the use of cannabidiol. “The work considered publications made from December 2020 to August 2022. More than 300 contributions were also collected through an open public consultation for doctors across the country”, says the entity.
Physicians who do not observe the determinations of the resolution will be subject to respond to processes in the CFM that, in the limit, can lead to the cancellation of the registration and the right to exercise the profession in the country.
