- The Brazilian cannabis industry has slowed down, in contrast to the enthusiasm witnessed earlier this year.
- In January, several businesses boasted that cannabis-based pharmaceuticals would be on the shelves of national pharmacies in the first half of 2021.
- The coronavirus pandemic, as well as Anvisa’s complicated restrictions, hampered the Brazilian cannabis sector.
In contrast to the excitement shown earlier this year, the Brazilian cannabis sector is wary. Several companies promised in January that cannabis-based medications would be on national pharmacy shelves in the first half of 2021. The bulk of them have had their deadlines pushed out to 2022.
The coronavirus pandemic and Anvisa – the Brazilian equivalent of USA’s FDA – with its complicated restrictions, have hampered the Brazilian cannabis sector. Brazil is just now entering a market that peaked in Canada and the United States in 2018.
In these countries, the cannabis industry has generated new employment, taxes for the government, and huge companies with New York Stock Exchange shares.
In Brazil, the problem is that few companies were created to serve as labs. “At the end of 2019, everyone felt we had won, but nobody actually did it,” said Jaime Ozi, who joined CanTera and OnixCann as a partner and vice president of business immediately after the regulation was released in 2019. According to Ozi, the difficulty of attracting funding has become much more difficult for cannabis entrepreneurs.
Unclear cannabis classification in Brazil
In the United States, cannabis is classed as a dietary supplement, but in Canada, it is classed as an herbal medication. In Brazil, Anvisa qualifies it as a phyto drug product and it will be classed as medication after five years.
According to the Brazilian cannabis companies, several of Anvisa’s criteria, such as the stability test, require a lengthy process. “It serves as a guarantee of shelf life in the medical cabinet. The proof attests that the product does not change within six months or a year and also warns in what temperature and humidity conditions the product should be kept,” said José Bacellar of VerdeMed, a Canadian company that operates in Latin America.
The stability test is merely one of the regulation’s 12 basic elements. Anvisa has even published a manual to aid in the understanding of the rules.
Large pharmaceutical companies like Aché and Prati have overcome these technological challenges, but smaller companies lack this know-how. The first registration for cannabis products has already started, but companies have until 2025 to do clinical studies. Seven of them claimed that they will not be able to complete the procedure in time to meet the requirements for the initial registration, which allows marketing to begin the following year.