Brazil is one of the top medical marijuana importers in the world. British, Canadian, American, and Chinese investors see the country as a place where medical marijuana cultivation and processing will flourish, but only when the government legalizes planting and processing within the country.
That wait may finally be over when this month Anvisa, Brazil’s health agency, publishes two proposals which outline deregulation protocols for cannabis cultivation, research, and medical applications of the drug.
The legislation only legalizes medical cultivation by companies and does not include licenses for patient cultivation groups or recreational cultivation. All recreational use remains illegal.
Anvisa has garnered investments from international companies looking to engage in the Brazilian medical cannabis market. But despite the investments and the decision to move forward with the proposal, the President’s ministry is still opposed to the proposal and public consultation. He sent a note to Folha de S. Paulo, a Brazilian daily newspaper expressing his disapproval of the proposal.
What is Anvisa’s proposal?
In November 2018, Brazil’s Senate passed a bill into law allowing cultivation of cannabis for medical and research purposes. Since then, the government has disallowed any planting until deregulation statutes become law.
Now the agency has published the first round of the deregulation rules and is seeking public opinion to approve, or disapprove, of them.
This proposal is two years in the making. Brazil’s government launched a technical panel in 2017 to build the framework.
“The regulation will be strict regarding the chain of production, distribution, and consumption of the medicines produced,” the agency said in an announcement.
On June 14, Anvisa published the proposals on the government’s official newspaper, the Official Diary of the Union.
One proposal identifies security concerns regarding cultivation. It proposes security and scientific rules, which will protect cultivation sites and workers.
The second seeks to define the rules regarding medical processing and prescribing.
Anvisa will hold two public consultations: one, focusing on security regulation for cultivation and the other on health regulation for the medicine produced from the cultivated plants.
Public consultations are a regular part of Brazil’s health ministry legislation process. In regards to medical cannabis, the agency stated that ultimately they want this law and any additional regulation to be “clear, transparent, and made with broad social participation.”
The consultations will run until August.
The President’s Office expresses disapproval while cannabis advocates say the proposed legislation does not go far enough
During Anvisa’s announcement of the proposals and public hearings, the Office of the President notified Folha that they disagreed with Anvisa’s plan to cultivate marijuana in Brazil.
Instead, the Office argued that Anvisa should focus on importing supplies of pre-made, cannabis-based medicine.
Folha reported that the critique primarily identified security concerns surrounding the growth and cultivation of marijuana. The psychoactive part of the raw material (tetrahydrocannabinol, or THC), if grown within the country, would be more readily available to lawbreakers.
However, Anivsa’s plan addresses securitization concerns. Security doors and security personnel would guard cultivation sites and staff. The sites would also be equipped with state-of-the-art biometric locks to prevent unauthorized access and use.
While the President’s Office is criticizing the bill for potential future abuse of cannabis, patients and patient advocates think the legislation is moving too slowly and that the statutes don’t go far enough to provide greater access for those in need.
Imported cannabis is costly for families already dealing with expensive and extensive medical needs. A single syringe of medical cannabis can cost a Brazilian family as much as $305 (USD 79).
With professional scale cultivation, the former president of the Brazilian Society of Cannabis Studies, Dr. Ricardo Ferreira told Huff Post Brazil, “At best, it will take 2 to 5 years for the drug to reach the pharmacies. And the demand of the patients is a real and urgent demand.”
Anvisa indicated on their website that their regulatory agenda for medical cannabis could extend at least another year.
Dr. Ferreira advocates for official acknowledgment of patient collectives to grow cannabis for medicine, which some are already doing.
Additionally, with such stringent security measures in place at the cultivation sites, the government effectively prevents smaller manufacturers from cultivating, including those who seek self-cultivation.
This past week patient advocates hung a banner on Anvisa’s headquarters with the message, “Anvisa, legalize cannabis self-cultivation for therapeutic purposes.” Many across Latin America share this view.
Since 2015, when Anvisa initially permitted medical cannabis imports and patient registration, the number of patients registered to receive medicinal cannabis has tripled, numbering 3,300 in 2018.
Anvisa is working toward coverage for as many patients in need as possible, despite the slow pace and the critiques from the executive branch.
The agency's president, William Dib, reiterated that point this past week stating, “What we can do to improve access is fundamental. We need to ensure the quality and effectiveness of this product that will [benefit] patients.”