Brazilian health regulators mull plan for cannabis cultivation and products, but proposal draws opposition

The Brazilian National Sanitary Surveillance Agency (ANVISA) released new rules for medical cannabis this week. (Photo courtesy of Beto Vasconcelos)

Brazilian health regulators are weighing a landmark plan to permit the domestic cultivation of marijuana and the registration of medical cannabis products that have not yet completed clinical trials, a move that would open a potentially huge market to MJ companies from around the globe.

But the proposed rules have encountered stiff opposition from a top government minister as well as psychiatrists and a regulatory agency that oversees Brazilian physicians.

Last June, the Brazilian National Sanitary Surveillance Agency (ANVISA) directors approved two draft resolutions to permit medical marijuana cultivation and the registration of MMJ products.

ANVISA is currently seeking public comment on the plan and held an open meeting on Wednesday to solicit feedback.

If a final version of the draft regulations are approved within the next few months, the move could pave the way to the creation of one of the world’s largest medical cannabis markets.

ANVISA’s president, William Dib, estimates that 13 million Brazilians suffering from different conditions could benefit from this proposal.

At least 20 companies from Canada, the United States, Israel, Australia, Uruguay and Europe have expressed interest in producing in Brazil, the newspaper Estadão reported.

As of July 31, ANVISA had received 590 comments about the proposed resolutions from businesses, doctors, patient associations and the general public. Only eight of the comments were negative toward the draft resolutions, according to Estadão.

The proposals are open for public comment until Aug. 19, and ANVISA expects to make a final decision by the end of October.

Government opposition

Not everyone in the government welcomes ANVISA’s plan.

ANVISA officials claim that current law allows the agency, which is linked to the Ministry of Health, to regulate the cultivation of cannabis and the registration of products.

The fiercest opposition to the plan comes from Osmar Terra, the minister of citizenship. Shortly after ANVISA’s proposal, Terra tweeted it was “against the law, against scientific evidence, against Congress and against the Brazilian government.”

Weeks later, Terra escalated his opposition, accusing ANVISA of proposing the regulation of medical cannabis as an excuse to “legalize the drug.”

In a more recent interview with the Brazilian news website Jota, Terra went even further, suggesting the agency could be shut down by the government if it moves ahead with the proposal.

“The agency … is a government body against the government. It doesn’t make sense,” Terra said.

He described ANVISA’s proposals as “very dangerous” and “irresponsible,” insisting that Brazilian President Jair Bolsonaro opposes the plan.

To undermine ANVISA’s proposal, the minister proposed the use of synthetic CBD, currently being developed by Brazilian pharmaceutical firm Prati-Donaduzzi.

Terra told Jota that any company looking to manufacture synthetic CBD would have the government’s support. Once a synthetic CBD product is registered, plant-based products with THC – such as Sativex, which is sold in Brazil under the name of Mevatyl – should be withdrawn from the market, according to Terra.

“Where there’s THC, there’s malefice,” or an evil spell, he said.

Government opposition isn’t unanimous, however. A congresswoman from Bolsonaro’s PSL party, Carla Zambelli, told the newspaper Folha that the discussion should take place in Brazil, as it’s happening everywhere else in the world.

More opposition

The Brazilian Federal Council of Medicine (CFM), which is the public organization in charge of regulating the medical profession, and the Brazilian Psychiatric Association (ABP) also oppose ANVISA’s proposals.

Together they published a document warning of the “high risk” of ANVISA’s proposals. The two organizations called on the agency to cancel the public comment period.

“By admitting the possibility of domestic cultivation and processing of the drug in the country, ANVISA takes a mistaken position, ignoring the public health risks that arise from this measure, “the document published by the CFM and the ABP contended.

The organizations noted that only CBD is authorized in the country as compassionate use imports. They also noted that the CFM prohibits doctors to prescribe cannabis in its “natural” form, as well as any extract that isn’t only CBD.

Those “compassionate use” rules do not apply to Sativex, being the only registered product in the market.

ANVISA replied to the CBP and ABP, arguing that its proposals do not suggest the use of cannabis in its natural form and that the motivation behind the plan was the increasing number of doctors prescribing medical cannabis under so-called compassionate use.

Latest public hearing

During the public meeting in Brasília on Wednesday, Dib, ANVISA’s president, defended the proposals, saying they’re “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”.

“Our main focus is to give the population access to medicines that today need to be imported,” said Alessandra Bastos, an ANVISA director.

Another director, Renato Porto, said that “ANVISA is permeable to the needs and demands of Brazilian society.”

Beto Vasconcelos, the founder of the XVV law firm and a former national secretary of justice in Brazil, attended the hearing. He told Marijuana Business Daily that “it was one more step in a technical, transparent and participative process in order to create this new regulation.”

“Two important points of the debate were about indoor versus outdoor cultivation and the importance of avoiding market barriers for medicine registration,” Vasconcelos said.

Alfredo Pascual can be reached at [email protected]

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