Date looms for Brazil decision on medical cannabis growing, product registration

Brazil’s Agência Nacional de Vigilância Sanitária – aka National Sanitary Surveillance Agency (ANVISA) – is expected to vote next week on two draft resolutions which could have sweeping ramifications for the medical cannabis industry.

If approved, the proposals would for the first time regulate the domestic cultivation of medical cannabis in Brazil and create a framework to allow the registration of marijuana-based medicines without completed clinical trials.

Producers would be able to sell their harvested crops only to research institutions or to manufacturers of registered cannabis-based medicines. Sales to individuals, wholesalers or pharmacies would remain prohibited.

The agency received more than 1,000 submissions on the proposals through the 60-day comment period ending Aug. 19.

Since then, authorities have been processing the feedback.

A vote on the final text is set to take place Tuesday. Approval requires a simple majority of the agency’s five directors.

ANVISA’s move received heavy opposition from various high-level government authorities.

As reported by Folha de S. Paulo, the proposals face resistance from within the health regulatory body.

One of the five directors was appointed in August by President Jair Bolsonaro, and he expressed concerns about allowing domestic cultivation.

Current Director-President Wililam Dib, who is a supporter of the proposals, will finish his term in December.

His successor could be closer to the Bolsonaro government’s position, signalling that sentiment from within ANVISA may turn against the regulations.

Another of the five directors will also be replaced by Bolsonaro in December.

While the vote is expected Tuesday, there’s risk of delay if one of the directors justifies a need for more time to evaluate the proposals.

Delaying the vote until after December would mean that the majority of the directors of the agency will be Bolsonaro appointees.

In an interview with Folha, Dib said that the final proposals will be almost the same as those originally proposed.

The director-president admitted he received pressure from the government  to not regulate cultivation, but also that he is optimistic about the proposals being approved.

Currently, Brazil has a restrictive import-only program.

More than 10,000 authorizations have been granted since the beginning of the program, and there are currently about 5,000 active patients.

Alfredo Pascual can be reached at [email protected]

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