The Federal Medical Board (CFM) has decided to authorize neurosurgeons and psychiatrists to prescribe cannabidiol-based drugs (CBD) for children with epilepsy who have tried traditional therapies but were unsuccessful. Cannabidiol is a by-product of cannabis plant, and CBD drugs are not made in Brazil.
The CFM decision will come into force in the upcoming days. However, patients will have to apply to the National Health Surveillance Agency (ANVISA) for permission to import the drug. Out of the 297 applications filed with ANVISA by early December, 238 were granted, 17 are pending applicants' arrangements, and 34 are still under consideration. The process takes a week on average before the import is authorized.
The initiative is seen as an important step towards legalizing the drug, since CBD users are required to submit a prescription and a medical report with their applications, in addition to a liability waiver and an import form. Before this permission, many doctors would refuse to prescribe cannabidiol for fear of sanctions.
The new policy has maintained the ban on prescriptions of cannabis sativa (marijuana) in its natural form and any other by-products except for cannabidiol which can only be used for medical purposes. Recommendations for doses and result assessment are also included in the policy. The purity levels and the form of administration must also comply with the guidelines set out by ANVISA.
“Studies in humans haven't fully established the safety and effectiveness [of cannabidiol] at this point, so more studies are urgently needed to provide stronger evidence in accordance with international standards of safety, effectiveness, and clinical applicability of CBD,” said CFM Chairman Carlos Corrêa Lima.
Both the doctors and the patients involved in CBD therapy will be required to sign up to a register which will be developed by their local medical board, so that the use of CBD can be monitored for safety and potential side effects.
Norberto Fischer and his daughter Anny, who has an epileptic disorder, have become champions in the struggle to legalize cannabidiol in Brazil. Norberto said the initiative is an important, but modest step, and considers the resolution as restrictive. He challenges the requirement to register patients and doctors, and most of all, limitation of prescriptive powers to surgeons and psychiatrists and on the dose that can be prescribed.
“There's just so much red tape. And on what grounds has CFM established this maximum of two doses when the board itself recognizes there are no parameters? My daughter, for example, has three doses a day. Moreover, how can the board say only children can benefit from using it?” argued Fischer, complaining that CFM has not heard users.
Translated by Mayra Borges