October 20, 2022
CFM updates its Resolution on cannabidiol prescription and use
The Federal Council of Medicine (CFM) published, on 10/14/2022, CFM Resolution No. 2,324/22, which authorizes the use of cannabidiol (CBD) for treatment of epilepsy in childhood and adolescence refractory to conventional therapies in cases of Dravet and Lennox-Gastaut Syndromes and Tuberous Sclerosis Complex. The aforementioned Resolution was approved after scientific reviews, with more than 300 contributions having been collected through public consultation.
The Council restricted cannabidiol prescription hypotheses to those specified in the Resolution, except in clinical studies authorized by the System formed by the National Research Ethics Commission and Research Ethics Councils (CEP/CONEP). Thus, doctors remain prohibited from prescribing cannabis-based medicines for the treatment, for example, of chronic pain, pain derived from diseases such as cancer, Parkinson, autism or Alzheimer, which are very commonly being treated with cannabis-based products. The prescription of Cannabis in natura for medicinal use, as well as any derivatives other than cannabidiol, is prohibited.
The doctor is also prohibited from giving lectures and courses on the use of cannabidiol and/or products derived from Cannabis outside the scientific environment and making publicity.
The main points brought by the new Resolution are:
- The regulation only authorizes the prescription of cannabidiol (CBD) as a medical therapy for the treatment of childhood and adolescent epilepsies that are refractory to conventional therapies in Dravet and Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex (the former CFM Resolution no. 2,113/2014 provided for the regulation of the compassionate use of cannabidiol as an exclusive medical therapy for the treatment of childhood and adolescent epilepsies that are refractory to conventional therapies, without specifying which ones);
- Prohibition of the prescription of Cannabis in natura for medicinal use, as well as any derivatives other than cannabidiol (this restriction was already provided for in the former CFM Resolution No. 2,113/2014);
- It no longer restricts the prescription of cannabidiol to neurology specialties and their areas of activity, neurosurgery and psychiatry, as was the case in the old Resolution;
- Furthermore, the doctors are prohibited from prescribing cannabidiol for a therapeutic indication other than what is provided for in the Resolution, except in clinical studies authorized by the CEP/CONEP System;
- The doctors are also prohibited from giving lectures and courses on the use of cannabidiol and/or Cannabis-derived products outside the scientific environment, as well as making publicity;
- Patients, or their legal guardians, must be informed about the potential risks and benefits in relation to the use of cannabidiol and sign the Free and Informed Consent Form. In this document, the patient also declares that he is aware that cannabidiol is not free from risks or health problems; and
- The Resolution must be reviewed within 3 (three) years from the date of its publication, when the scientific literature must be evaluated.
Considering that the new text maintains its restrictive character, this Resolution gives rise to several discussions and questions, especially regarding the autonomy of doctors, health and quality of life of patients who use cannabis for health treatments.
CFM Resolution No. 2,324/2022 revokes CFM Resolution No. 2,113/2014 and came into force on the date of its publication (10/14/2022).
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