Brazilian health regulators unexpectedly postponed another vote on a groundbreaking proposal to regulate the cultivation and registration of cannabis-based medicines, delivering a further blow to efforts to open up fresh business opportunities in Latin America’s largest medical cannabis market.
The directory of the Brazilian Agência Nacional de Vigilância Sanitária – or National Sanitary Surveillance Agency (ANVISA) – was expected to vote Tuesday on two resolutions that for the first time would have established a regulatory framework on the domestic cultivation and registration of cannabis-based medicines without the need for finished clinical trials.
But two of ANVISA’s five directors – Fernando Mendes and Antonio Barra – asked to postpone the vote, effectively blocking any decision from happening.
Mendes asked to delay the vote on the registration proposal; Barra asked to delay the vote on the cultivation proposal. They declined to give a reason for the move.
In voicing support for the proposed changes, ANVISA’s Director-President William Dib noted the overwhelming support received during the public comment period.
Dib also said the current system of individual imports of products fails to provide patients guarantees of safety, quality and efficacy. The imported products are also expensive and sometimes risky, according to ANVISA’s director-president.
He cited an analysis of a Brazilian university showing imported products that weren’t even labeled correctly, including a high variability of CBD that didn’t coincide with what’s stated in the label.
Beto Vasconcelos – founder of the XVV law firm and a former national secretary of justice in Brazil – told Marijuana Business Daily that ANVISA will probably reconvene 15 days from now to try to vote on the proposals.
Vasconcelos cited three possible outcomes:
- The directors could simply vote, after having had time to review the final proposals presented Tuesday.
- Mendes and Barra could vote only on the proposal each asked to delay voting but then ask to delay the vote on the ones they hadn’t sought to postpone. That would effectively delay a decision two more weeks. With that, the next meeting would be closer to December.
- If Mendes and Barra again attempt to delay any action, Dib, the president-director, could reject their efforts and order a vote.
Because of upcoming changes in ANVISA’s directory, the closer to December the decision is delayed, the slimmer the chances of approval.
Alfredo Pascual can be reached at email@example.com