By Silvia Muñoz, ICCI.
2019 has been a busy year for the cannabis industry in Brazil.
In October, Bill N. 5295 of 2019 was presented to the Brazilian Senate to address the issues of finally legislating the growing cannabis and industrial hemp business in the country.
The Brazilian Sanitary regulatory agency, or ANVISA, for all intents and purposes functions similarly to the United States’ Food and Drug Administration (FDA). And, this week, the organization approved the proposal of an official regulation for the medical use of Cannabis Derivatives.
This is not only a historical moment for Latin America but also for the country of Brazil, which is currently chafed under a very conservative government.
After carefully translating all of the pertinent documents produced this week, here are the things to consider in the near future for Brazil and the Latin American cannabis market.
How Is Cannabis Currently Handled In Brazil?
Since 2015 Anvisa has allowed the medical prescription of cannabis-based products. Mevatyl is the only legal medical cannabis product registered. In addition, Brazil has partially decriminalized the personal use and possession of small amounts of cannabis.
In terms of medical use: patients with a medical indication for the use of cannabis products needed import authorization. To date, pharmacies cannot sell these medicines, even if produced by an international company.
Instead, patients have to fill out a form on Anvisa’s website, submit a medical report and a prescription, and then import the product. This process could take up to 60 days to complete and is very expensive for the average Brazilian.
According to Globo, some doctors reported that the process for treating epilepsy, for example, could cost $1,000 Brazilian Reais ($238) per month.
The regulation defines two types of prescription:
- Prescription A for compounds of more than 0.2% THC, stipulated only for terminal patients.
- Prescription B, which are all products with less than 0.2% THC.
What Changed With This New Proposal?
ANVISA’s resolution proposes a new classification for cannabis, a “third way”.
Products will not be classified as medicines nor food supplements. It’s basically… well, cannabis-based products.
According to a Medium post by Fabricio Pamploma, “The new product classification allows ANVISA to regulate the matter how …