Brazil takes a step back in regulating medical cannabis

The Federal Council of Medicine of Brazil this week published a new regulation on medical cannabis, which prohibits doctors from prescribing raw cannabis for medicinal use, as well as any derivatives other than cannabidiol (CBD). THE Resolution 2324/2022, which approves “the use of cannabidiol for the treatment of epilepsies in children and adolescents that are refractory to conventional therapies in Dravet and Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex” — the same described in the leaflet of the epidyolex — further prohibits Brazilian doctors from prescribing CBD for any other therapeutic indications and from giving lectures or courses on the use of CBD and/or cannabis-derived products outside the scientific environment.

The measure is causing outrage all over Brazil, from patient associations to lawyers, jurists and health professionals, who consider it “a setback” in legislation. O document, published on October 11 in the Official Gazette (DOU), “approves the use of cannabidiol for the treatment of child and adolescent epilepsies refractory to conventional therapies in Dravet and Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex” , exactly the same as those described in the Epidyolex leaflet, leaving out all the other pathologies for which cannabis was already being used by thousands of people in Brazil.

According to Resolution 2324/2022, physicians are now prohibited from “prescribing cannabidiol for therapeutic indications other than those provided for in this Resolution, except in clinical studies authorized by the CEP/CONEP System”. It is also prohibited “the prescription of cannabis in natura for medicinal use, as well as any derivatives other than cannabidiol”, which completely invalidates the medicinal use of the full spectrum of cannabis and other cannabinoids, such as THC, CBN or CBG, among others.

In addition, physicians 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 advertising”, can be read in the article. document.

The Resolution, signed by José Hiran da Silva Gallo, President of the Federal Council of Medicine of Brazil, also establishes that the norm “must be reviewed within 3 (three) years from the date of its publication, when the scientific literature".

Resolution totally contradicts the current reality in Brazil
About a year ago, ANVISA, the Brazilian health authority, authorized a list of 249 cannabis derivatives for importation into Brazil, of which five contain essentially THC and the remaining CBD. Furthermore, in recent years, the Brazilian courts have issued hundreds of Habeas Corpus, which allowed patients and associations to grow cannabis as the only form of access. On the other hand, there are associations, such as Santa Cannabis, which are growing cannabis for their patients and offering courses in cultivation and extraction based on civil disobedience.

It remains to be answered how the new Resolution will be implemented in a reality that is completely at odds with the measure that is intended to be implemented.

Cannareporter is asking for feedback from various civil society stakeholders in Brazil, such as physicians, educators and patient associations, and will update this information as it receives feedback.