After criticism for restriction, the Federal Council of Medicine opens public consultation on the use of cannabidiol

The CFM (Federal Council of Medicine) announced this Thursday (20) that it will open a public consultation to update the resolution on cannabidiol prescription published in the Official Gazette on the 14th. The determination has been receiving criticism from patients, family members and professionals of health, which criticize its restrictive character.

Unlike the consultation on the subject that took place between July 1 and 31, 2022 and brought together contributions from doctors and medical entities, the new public consultation will be open to the entire population.

According to CFM, contributions can be sent online from October 24 to December 23. Interested parties should access the platform being created on the entity’s website and provide some data, such as the CPF number and the municipality of residence. Then, it will be possible to position yourself on each of the articles of the current resolution.

The information will be treated under the criteria of confidentiality and anonymity and will serve as a subsidy for the CFM to reassess the rules on cannabidiol prescription, which are still in force.

In the current document, which replaces the rules stipulated in 2014, the council stipulates that cannabidiol can be used for the treatment of children and adolescents with epilepsies refractory to conventional therapies in Dravet and Lennox-Gastaut Syndrome and in Tuberous Sclerosis Complex.

Head of the Department of Neurology at Unicamp (State University of Campinas) and ambassador for epilepsy in Brazil, neurologist Li Li Min evaluated the new resolution (number 2,324/2022) as very restrictive. For him, the document should not help the clinical use or research on cannabidiol in the country.

He explained that in about 70% of epilepsy cases, control is possible with medications available on the market. For the other 30%, it is necessary to resort to alternative therapies and the three tables provided for in the CFM document represent the smallest part of this group.

According to Li, clinical trials were carried out with the use of cannabidiol in these three situations, but there is evidence of efficacy also for other diseases, which the document does not consider.

He also regretted the restriction imposed by the CFM on lectures and courses on cannabidiol. He also criticized the three-year minimum time the entity had allotted to review the rules.

In the note in which he announced Wanted this Thursday, the CFM did not

In the note released this Thursday, the CFM did not explain whether the opening of the public consultation means that the resolution on the use of cannabidiol will be modified in less than three years or if it will wait the period previously foreseen to make possible changes.

In the text, the entity stated that, to formulate the resolution, it was based on evidence-based medicine, evaluated almost 6,000 scientific articles and considered the collaboration of the consultation with doctors.

“The conclusions point to still fragile evidence on the safety and efficacy of cannabidiol for the treatment of most diseases, and there are scientific studies with confirmed positive results only for cases of epileptic seizures related to Dravet, Doose and Lennox Syndromes- Gastaut,” the agency said.

Pressure

The resolution provoked a reaction from several bodies and entities. On Monday (17), the MPF (Federal Public Prosecutor’s Office) opened a procedure to investigate the rule and gave the CFM 15 days to send documents that demonstrate the scientific evidence that supports the resolution.

This Thursday, a group of 137 legal professionals published a note in which they criticize the new resolution. Called “Advocacy for Medicine”, the coalition states that it is willing to “legally confront the unfair rules” of the CFM.

“The recent resolution disregards regulatory and scientific developments regarding the use of cannabis in various treatments, such as epilepsy, autism, cancer, chronic pain, multiple sclerosis, Parkinson’s, Alzheimer’s, HIV, motor disorders, diabetes, nausea, headache, ischemia, in addition to its applicability with immunomodulatory, anti-inflammatory, antitumor, analgesic, among others, in addition to its various neurological, orthopedic, rheumatological, gastrointestinal, psychiatric and, above all, geriatric and palliative applications”, says an excerpt from the note.

“In addition, we remind you that the doctor is forbidden to stop prescribing the products of cannabis when it is the correct and adequate therapeutic tool for the individual case (art. 102 of the Code of Medical Ethics), considering that the products are regulated and available in the country”, he adds, in another passage.

“The social transformation triggered by the cannabis in medicine is an undeniable reality and here we are united to defend threatened rights through all legal means that are necessary, and, especially, to dialogue with everyone involved in this issue”, concludes the note from the jurists.

Also this Thursday, five industry entities released a note expressing concern about the resolution, which places “barriers to the dissemination of scientific knowledge and obstacles to the promotion of research”.

In the document, signed by BRCann (Brazilian Association of Cannabinoid Industries), Abiquifi (Brazilian Association of Pharmaceutical Inputs Industry), Abifina (Brazilian Association of Fine Chemicals, Biotechnology and their Specialties), Abifisa (Brazilian Association of Companies in the Phytotherapeutic, Food Supplement and Health Promotion) and Abracro (Brazilian Association of Representative Organizations for Clinical Research), “the entities make themselves available to the Federal Council of Medicine for further technical discussions on the subject, and they consider it opportune to open a dialogue”.