Brazil’s Agência Nacional de Vigilância Sanitária – a.k.a. National Sanitary Surveillance Agency (ANVISA) – is anticipated to vote subsequent week on two draft resolutions which could have sweeping ramifications for the healthcare cannabis business.
If authorized, the proposals would for the very first time regulate the domestic cultivation of healthcare cannabis in Brazil and generate a framework to enable the registration of marijuana-primarily based medicines devoid of completed clinical trials.
Producers would be capable to sell their harvested crops only to analysis institutions or to suppliers of registered cannabis-primarily based medicines. Sales to people, wholesalers or pharmacies would stay prohibited.
The agency received far more than 1,000 submissions on the proposals by means of the 60-day comment period ending Aug. 19.
Due to the fact then, authorities have been processing the feedback.
A vote on the final text is set to take place Tuesday. Approval demands a very simple majority of the agency’s 5 directors.
ANVISA’s move received heavy opposition from different higher-level government authorities.
As reported by Folha de S. Paulo, the proposals face resistance from inside the overall health regulatory physique.
A single of the 5 directors was appointed in August by President Jair Bolsonaro, and he expressed issues about enabling domestic cultivation.
Present 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 inside ANVISA may well turn against the regulations.
An additional of the 5 directors will also be replaced by Bolsonaro in December.
When the vote is anticipated Tuesday, there’s threat of delay if one particular of the directors justifies a want for far more time to evaluate the proposals.
Delaying the vote till immediately after December would imply that the majority of the directors of the agency will be Bolsonaro appointees.
In an interview with Folha, Dib mentioned that the final proposals will be pretty much the identical as these initially proposed.
The director-president admitted he received stress from the government to not regulate cultivation, but also that he is optimistic about the proposals getting authorized.
At the moment, Brazil has a restrictive import-only system.
A lot more than 10,000 authorizations have been granted given that the starting of the system, and there are at the moment about five,000 active sufferers.