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Brazilian Regulators Could Soon Approve Cannabis Cultivation

Aug 06, 2019

Brazilian Regulators Could Soon Approve Cannabis Cultivation

A health regulatory agency in Brazil could soon permit the country’s first domestic cultivation of cannabis for medicinal use. 

It’s hoped the move that could reduce the country’s heavy reliance on internationally imported medical cannabis and open up the Brazilian market to cannabis companies worldwide. 

But since its initial unveiling, the new plan has attracted stiff opposition from a number of top-level sources, including psychiatrists and a top government minister. 


Brazilian regulatory agency seeks reform

In June, a public meeting of the National Sanitary Surveillance Agency (Anvisa), the body responsible for cannabis regulation in Brazil, saw the agency’s collegiate directors vote unanimously in favor of approving two draft resolutions that would reform its current approach to cannabis.

The first of these would see the agency regulate the domestic cultivation of cannabis for the first time. The cultivation would exclusively be for medical and scientific purposes, and would be carried out in compliance with the international 1961 Single Convention on Narcotic Drugs treaty. 

The second would have Anvisa review the current registration procedures for medical cannabis products, including synthetic cannabinoids and cannabis derivatives. It was proposed that Anvisa could begin allowing the commercialization of cannabis products that have completed only the second phase of clinical trials. 

Anvisa authorities say that enacting these new rules would be enough to begin regulating cannabis cultivation and the reviewal of the product registration system; no additional legislative change from parliament would be needed for the resolutions to take effect. 

The change is needed, Anvisa authorities say, because many Brazilian patients have had trouble accessing “safe” cannabis products, and they would like to see local production and regulation become part of the solution to this problem. 

A 60-day public comment period on the proposed resolutions is now underway, with Anvisa seeking feedback from relevant companies, universities, government agencies, health professionals, and the general public on the proposals. 

As of July 30, Anvisa has received 590 official comments on the new rules, with only eight of those responses being negative toward the draft resolutions, according to Estadão


Select government ministers condemn the plan

Anvisa says that as it has a mandate to make regulatory changes to already-existing laws without the approval of parliament, this would also give the agency the power to decide to regulate cannabis without parliamentary approval. 

This existing mandate may come as a relief to cannabis reform advocates in Brazil, as some members of the current government have been very vocal in their disapproval of the plans since they were announced. 

Leading the opposition is Osmar Terra, the minister of citizenship. Terra sent out a tweet shortly after the unveiling of the draft proposals which branded the planned reforms “against the law, against scientific evidence, against Congress and against the Brazilian government.”

“[Anvisa] is a government agency against the government” said Terra, in an interview with the Brazilian news website Jota. “It doesn’t make sense.”

Terra went on to call Anvisa’s proposals “very dangerous” and “irresponsible.” Terra also suggested that Anvisa could be shut down by the government if it continues with the proposals.

But, a source from within the Ministry of Health appears to contradict this threat. The anonymous source, speaking in a separate interview with Jota, confirmed that the government generally does disagree with Anvisa’s proposals, but views any direct intervention as being too politically risky to carry out. 

In the rest of his interview, Terra did say that the government would support the use and manufacture of synthetic cannabidiol (CBD) products, so long as they contained no traces of tetrahydrocannabinol (THC). He stated that President Bolsonaro agreed with this assessment.

Tem de estar puro o canabidiol. Quando estiver com THC, é a droga que causa dependencia,” said Terra, meaning, “Cannabidiol must be pure. When with THC, it is the drug that causes addiction”.

Not all ministers are in opposition to the plans. Congresswoman Carla Zambelli, of President Bolsonaro’s PSL party, told the newspaper Folha that discussion of cannabis reform should be indeed be facilitated in Brazil, just as it is in other parts of the world.


Public hearing goes ahead despite calls to cancel

Voices outside of politics have also cautioned against the new Anvisa proposals. 

The Brazilian Federal Council of Medicine (CFM) and the Brazilian Psychiatric Association (ABP) jointly published a document in June that dubbed the proposals “high risk” and urged Anvisa to cancel the public comment period. 

The organizations noted that only pure CBD is currently authorized for use in the country, and even this is under “compassionate use” rules. They also contend that the CFM prohibits doctors from prescribing cannabis in its “natural form,” as well as any prohibiting any products that are not pure CBD.

Anvisa responded, saying that its proposals do not advocate for the use of cannabis in its “natural” plant form. Anvisa also argued that the new regulations aim to serve exactly those doctors who are seeking cannabis products for their patients as a last resort under the compassionate care rules; repeating that they want to improve access to medicines for doctors, not simply inflate the number of medical cannabis patients. 

Despite the requests of the CFM and ABP, a public meeting was held last week to further discuss the proposals, ahead of the closing of the public comment period in mid-August. 

Speaking at the hearing, Anvisa’s president William Dib defended once again Anvisa’s plan, saying that it is “robust, good, coherent, safe, effective and that it will provide peace of mind for the citizen to be able to consume a product of better origin than what we are seeing today.”

 

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