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MPF opens investigation into CFM regulation for cannabidiol

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The Federal Public Ministry (MPF) opened a preparatory procedure, this Monday (17), to investigate the legality of a resolution by the Federal Council of Medicine (CFM) that established new rules for the prescription of cannabidiol-based drugs, a derivative from Cannabis, the marijuana plant.

The medical entity‘s document, published last week, authorizes the use of cannabidiol only for the treatment of child and adolescent epilepsies that are refractory (unresponsive) to conventional therapies in Dravet and Lennox-Gastaut Syndrome and Tuberous Sclerosis Complex. .

According to the prosecutor of the Republic Ailton Benedito de Souza, responsible for the procedure, the investigation will determine whether there is compatibility between the CFM resolution with the social right to health, under the terms of the Federal Constitution, and other official regulations, such as those of the CFM itself. National Health Surveillance Agency (Anvisa), which in 2019 authorized the manufacture and import of products with Cannabis for medicinal purposes.

As a first step, the MPF requested documents from Anvisa that show the scientific evidence that supports the current authorizations for the medicinal use of Cannabis in Brazil. The Federal Prosecutor also requested documents from the CFM that demonstrate the scientific evidence supporting the entity‘s new resolution. Information on the administrative, financial and technical repercussions on the Unified Health System (SUS) of the Anvisa and CFM resolutions was also requested from the Ministry of Health. The deadline for responses is 15 days.

According to data from Anvisa itself, it is estimated that more than 100,000 patients undergo some type of treatment using Cannabis. In addition, more than 66,000 cannabis-based medicines were imported in 2021. Around 50 countries have already regulated the medicinal and industrial use of cannabis and hemp.

The CFM measure is valid for 3 years and is the body’s first orientation since 2014. The resolution prohibits doctors from prescribing Cannabis in natura 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). Physicians 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 them. 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.

Also 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”, argued the entity.

Reaction

Next Friday (21), patients who use medical cannabis will make a silent protest at the CFM headquarters against the resolution. According to the Pan-American Association of Cannabinoid Medicine, the alleged scientific evidence listed by the CFM in the standard was restricted to studies published more than 8 years ago and did not update the most recent academic findings, citing PubMed, one of the largest databases in the world. biomedicine in the world.

“Currently, there are almost 30,000 researches on the medicinal use of Cannabis on PubMed alone, not to mention other scientific databases. On the website it is possible to verify that between 2018 and 2022, about 10,000 scientific articles were produced on the medicinal use of cannabis. Cannabis. But it seems that the research that supports the regulation of Cannabis in more than 50 countries is still unknown by CFM advisors”, says the note from patients and representatives of civil society entities.

Translated to english by RJ983

From Brazil, by EBC News

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