By Anita Krepp
Medical regulatory body bans THC prescriptions, restricts CBD to only two pathologies and censors doctors, who are now banned from holding courses and conferences on cannabis
A new resolution of the Federal Council of Medicine (CFM), published last Friday (14 October), made the therapeutic indication for medical cannabis in Brazil even more restrictive. Under the new rule, prescriptions for THC and any other cannabis compounds other than cannabidiol (CBD) are now prohibited.
CBD, in turn, had its use restricted to the treatment of only two pathologies in children and adolescents with very specific epilepsies: Dravet and Lennox-Gastaut syndromes (progressive encephalopathy associated with difficult-to-control seizures) and Tuberous Sclerosis Complex (characterised by the growth of benign tumours in various organs and epilepsy). Which, for the lawyer, Cristiano Maronna, is a ‘manifest illegality in the right to health’ of adults and elderly people.
The CFM also imposed censorship on doctors, who are now prohibited from providing courses and conferences on medical cannabis outside the scientific environment – which excludes universities –, preventing the exchange of information and knowledge in academic environments and thus making it impossible for new and experienced doctors to learn about the interactions of cannabinoids with the endocannabinoid system. In addition, advertisements or self-promotion from doctors, through posts about cannabis on social media, are also banned.
Resolution 2324/2022 is an updated version of the resolution published in 2014 when medical cannabis imports were authorised by Anvisa (Sanitary Surveillance Agency). At that time, the CFM, the regulatory body for the procedures of the medical profession, began to determine how and when the substance could be prescribed to patients.
Considering the various scientific updates that have supported cannabinoid therapeutics in recent years, the industry’s expectation was that the update could loosen the board’s mandates for medical cannabis. However, the opposite has happened, and, against the grain of science and the exponential increase in cannabis patients in Brazil, CFM has surprised everyone with the new restrictions, even tougher than the previous ones.
In a statement, the regulatory body said that the plenary of the council approved the new resolution after scientific reviews on the therapeutic applications and the safety of CBD published between December 2020 and August 2022. However, research from 2015 onwards has not been cited in the document, while there are several references from the 1970s up to the 1990s. This means the recent resolution is already outdated.
Juridical insecurity
There are more than 160,000 medical cannabis patients in Brazil, through three forms of access: imports, patient associations and pharmacies. The upward curve in the number of cannabis patients in Brazil has grown 15 times in the last 5 years. If everything continued as it was, the prediction was that this number would reach 200, 000 by May 2023. The publication of the new resolution alarmed the industry as a whole, but mainly doctors and patients, uncertain about the future of treatments already started and those about to start.
The climate of legal uncertainty caused, at first, some doctors to consider the possibility of stopping their medical cannabis prescriptions, but after several meetings between doctors and lawyers – which have taken place on a daily basis since the measure was published – normality seems to have been restored; none of the 3,000-plus prescribing physicians has failed to attend their patients so far.
Although the CFM threatens fines and even to revoke the right to practise medicine, Claudio Lottenberg, chairman of the board of the Albert Einstein Hospital, the most renowned hospital in the country, says that any procedures in this regard would not have legal support. ‘There may be embarrassment, it may generate a headache for the doctor, but nothing will come of it, because Anvisa will always support,’ he explains, remembering that the health agency has already authorised 18 cannabis medicines in Brazil, including Mevatyl, a compound made up of 2.7 mg of THC and 2.5 mg of CBD.
Political issues
‘They are politicising science,’ denounces Lottenberg, regarding the approach of CFM to Bolsonarism (movement of support for the current president, Jair Bolsonaro, who supported doctors in the right to prescribe chloroquine in an off-label use for Covid, when its ineffectiveness was already scientifically proven).
The perception that the regulatory body’s position is due to political reasons is widespread, and, for this reason, the strategy of the lawyers involved in the case is to avoid the judicial route at first – at least until 30 October, when the second presidential election round will take place, with ex-president Lula as the favourite.
‘Right now, we are guiding doctors to position themselves within the regional councils of medicine and other specialist medical organisations to pressure the CFM to change these rules,’ reveals Emílio Figueiredo, from the Rede Reforma, a group of lawyers working for advancement in drugs policy.
Despite the initial scare, nothing has changed for pharmaceuticals and importers operating in Brazil. We spoke with VerdeMed, which imports products from Colombia’s Clever Leaves; with Ease Labs, which imports from an Italian company, and with USA Hemp, headed by Brazilians in the United States, and confirmed that they continue to work as normal with the support of Anvisa, which, after consultation, affirmed that they will keep ‘the current regulation for the purpose of authorisation of cannabis products for medical purposes, regardless of the resolution of the CFM’.
The attempt of the more conservative movements in Brazil to ban medical cannabis could mean they end up shooting themselves in the foot. Doctors, patients, and businessmen in the industry are coming together in an unprecedented way, placing their differences aside and realising that the only way to make progress and stop setbacks is to fight together. Reaction against the setback seems to be gaining strength.
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