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Brazilian doctors against liberalization of medicinal cultivation

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The Federal Council of Medicine (CFM) and the Brazilian Association of Psychiatry (ABP) made published a joint note warning “the high risk in the proposed regulation of the cultivation of Cannabis sativa L.” and ask for the revocation and cancellation of public consultation on the subject.

At the origin of this note is the call from ANVISA – National Health Surveillance Agency, on June 11, for the public consultation to discuss the cultivation and use of cannabis for medicinal purposes in Brazil, as well as regarding the registration of herbal medicines.

For the CFM and ABP, Anvisa's decision “disregards scientific evidence and does not guarantee effectiveness and safety for patients”.

The document from the medical associations admits that “Anvisa assumes the wrong position, ignoring the risks to public health” regarding the possibility of liberalizing the cultivation and processing of cannabis

“To date, only cannabidiol, one of the derivatives of  Cannabis sativa L. , for having minimal studies in the form of research, is authorized for compassionate use under medical prescription in the treatment of epilepsy in children and adolescents refractory to conventional methods”, says the joint text of the CFM and the ABP. “This is provided for in CFM Resolution No. 2.113/2014, which, in turn, prohibits doctors from prescribing the  cannabiss in natura for medicinal use, as well as any derivatives other than cannabidiol”.

Note does not understand the real purpose of the regulation

Anvisa, published a note of clarification to the medical class in which it regrets the
In response to the note from doctors' organizations, the health regulatory body concluded that "Anvisa would not be presenting this proposal with this content if it were not to serve patients and doctors  who often have cannabis-based medicines as the only or even the last therapeutic alternative”, said the health agency. “Anvisa's work seeks to meet the demand for patients and doctors  for access to safe and effective medicines. There is nothing in the texts proposed by the Agency that suggest the use of the plant  in natura . "

Anvisa also reinforced to the groups of doctors that it is “the regulatory agency legally defined in Brazil to register medicines in the country” and that “if today there is a growing number of patients in the country being treated with cannabis-based products, it is the result of prescriptions”. performed by doctors responsible for the therapeutic choice”.

Make your contribution on the following links:
– Public Consultation No. 654/2019 –  Specific procedure for registration and monitoring of drugs based on Cannabis spp., its derivatives and synthetic analogues

– Public Consultation No. 655/2019 – Technical and administrative requirements for the cultivation of the Cannabis spp plant. for medicinal and scientific purposes, and makes other provisions

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