We Translated Brazil's New Cannabis Rules: Here's What You Need To Know
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 it deserves (and needs) to be regulated.”
It is important to take account the following highlights:
- The new guidelines will allow the sale, supervision, manufacturing and import of medicinal products derived from cannabis.
- Manufacturers that choose to import cannabis substrate for the manufacture of the product could import the semi-finished raw material. Not the cannabis plant or part thereof.
- Companies should submit Cannabis Health Authorization to Anvisa and must meet Anvisa’s pharmaceutical standards for quality
- Cannabis will not be able to be advertised as medicines, nor claim any particularly therapeutic effect.
- The indication and manner of use of cannabis products is the responsibility of the attending physician. In addition, patients should be informed about the use of cannabis product. Therefore, he or his legal representative must sign an Informed Consent Form (ICF), which details cannabis product-specific data.
- Patients with prescription for the use of products with THC and / or CBD, could buy the drugs directly from pharmacies.
What Are Exceptional Imports Like?
Imports of cannabis products such as cannabidiol (CBD) require a special authorization. To apply for this authorization you must access the Federal Government services page. Check out the electronic form to apply for authorization for exceptional cannabidiol import.
What Was Not Allowed Or Did Not Pass Yesterday?
Unfortunately, the cultivation of medicinal cannabis was rejected, with the decision that manufacturers wishing to enter the market will need to import the plant extract.
However it is important to add that, even though cultivation was not allowed, Sechat reported that the Federal Court of the Federal District of Brasilia authorized one specific company, Schoenmaker Humako Agri-Floriculture, part of the Terra Viva group, to import industrial hemp seeds and grow plans with THC concentration below 0.3%.
The decision is valid from 15 days onward and came hours after Anvisa filed the proposed resolution for the cultivation of the plant for medicinal purposes and research in Brazil.
So What’s Next And What Should We Look Into In The Future?
Accoring to Anvisa’s press release, the approved regulation will be published in the “Official Gazette” in coming days and will be effective 90 days after publication.
The Board's decision establishes that the rule, called Resolution of the Collegiate Board (RDC), should be reviewed within three years of publication in the Federal Official Gazette, precisely due to the technical-scientific stage on which the products are based.
The regulation doesn’t mention the need of clinical studies or/and research or any sort of proof of efficacy of safety. However, companies should not abandon their research strategies to prove the effectiveness and safety of their formulations.
What Are The Grey Areas?
Will the new Anvisa guidelines invalidate the current process?
Well, this is a great question: Anvisa hasn’t disclosed how the transition process will be.
The official regulation has not been published yet and things like what would be considered a semi-finished raw material and other stipulations for the import of cannabis-based products and materials are still not clear.
ANVISA is considered to be one of the most complete and regulated organizations in Latin America for both consumers and patients’ safety. Achieving a cannabis regulation through it could mean Brazil becoming a key player in the Latin American cannabis market, not only because of its geographical and climatic diversity, but also for how significant the market would be within the Brazilian population.
Brazil has taken a step forward. However, we still need to wait for the official publication of the regulation to analyze the details .
Pamplona further elaborates: “Could it be better? Surely. Cultivation should be allowed in the country. But it could be way WORSE, I think. The proposed regulation is in line with most international regulations and we'll have room for improvement after this first nation-wide experience. It's an historical day and I am an optimistic.”
By means of conclusion, Viviane Sedola from Dr. Cannabis added, “Having an actual rule to follow is the main point. Brazil sets foot in the cannabis market, doctors feel safer to prescribe and patients have easier access.”
Silvia Muñoz is a cannabis industry insider and Responsible for Government Affairs LATAM in the International Cannabis and Cannabinoids Institute in Czech Republic.
Photo by Javier Hasse.
The preceding article is from one of our external contributors. It does not represent the opinion of Benzinga and has not been edited.
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