Brazilian Medical Cannabis regulation is finally in place. What happens now and who will benefit from it?
Yesterday was a historical day from Brazilian citizens, and particularly those supporting and advocating for medical Cannabis for so many years, like me.
The president of Brazilian health regulatory agency — ANVISA — Dr. William Dib decided to swim against the current wave of conservative thought in the country and propose an official regulation for the medical use of Cannabis derivatives. This is on top of the work of previous ANVISA presidents, who organized an "exceptional rule" for the importation of CBD-based products. Starting today, and with effect in 90 days, Brazil has a proper Medical Cannabis regulation in place.
This was a busy week for the Brazilian Medical Cannabis community starting with a decision to deny a broad patent claim on "CBD oils" from a Brazilian industry, the proper regulation of the sector and a judicial decision favoring a company to cultivate hemp in large scale.
I am proud to say that all 3 initiatives had some contributions from myself and a few colleagues, including Lorenzo Rolim da Silva (Agronomist & Business Developing) and Antonio Vieira (Lawyer), who also contributes to the blog.
My compliments to everyone involved. And this is just the kick-off of some exciting years to come for the country and one step closer to the long sought symptoms relief of Cannabis derivates for the patients.
What changes with the regulation?
It's just the kick-off, but we'll certainly observe some immediate changes. The responsible companies and organisms will stand up and address the necessary medical demands and start to serve patients. The Brazilian regulation didn't allow Cannabis cultivation, which will agitate the international market, since we are speaking about one of the biggest potential consumers markets in the world. Overall, the regulation is in line with Canada and Portugal, which were the biggest benchmark for the whole process. And… this is just an experience, because the norm will be necessarily revised in 3 years, according to the press release from ANVISA.
Under these circumstances, the companies that want to manufacture Cannabis-based products will have to import the standardized extracts (not the flowers) from other countries, and expect to have access to Brazilian-grown Cannabis for a future price drop. Important to mention, a huge part of the whole pharmaceutical industry in Brazil already operates with imported APIs, so nothing new here, but obviously disappointing for those expecting to substitute the gigantic Brazilian fields of sugarcane or soy for hemp or weed.
These are the basic requirements for a "Cannabis company" under the new Brazilian regulation:
. Authorization to manufacture or import medicines, issued by ANVISA (AFE).
. Special authorization to work with controlled substances (AE).
. Good Manufacturing Practice (GMP or "BPF") for the manufacturer.
. Good practice in Distribution and Storage of Medicines.
. Technical rationale to justify the administration route and use of the product formulation/composition (particularly when it comes to THC/CBD ratio because it affects classification).
· Detailed technical documentation of pharmaceutical quality (CoAs, stability, everything that you normally find on a drug master file — DMF).
· Capability to conduct quality control and emit certificate of analysis (CoA) in Brazil, with a certified laboratory.
· Capability to receive and treat the adverse events notifications and technical complains about the product.
· Technical description of the concentration of the main cannabinoids in the formulation, particularly THC and CBD.
Again, nothing new, in the pharmaceutical market, this is the very least. However, for the Cannabis enthusiast, and particularly for the hungry investors looking for the low-hanging fruit that might be a little too much.
Compound pharmacies and patient associations are apparently out of the plans, at least for now. Animal treatments are also not allowed.
The greatest insight: Cannabis-based products are NOT registered medicines. Claps to ANVISA this is the real game-changer.
This changes everything. Since a new class of products was created, Cannabis-based products are something else, a "third way", not a registered medince, not a food supplement. It's basically… well, Cannabis-based products.
The original product classification allows ANVISA to regulate the matter how it deserves (and needs) to be regulated. Therefore
It's very close to the direction that Canada and Portugal already took, they were big influencers of the whole Brazilian regulation. Back in 2015, I was in person with the agents of the regulatory agency in Canada, introducing them to the market, visiting cultivation and production sites. They also interacted directly with Health Canada and INFARMED, the Portuguese agency.
The Cannabis-based products will have to meet pharmaceutical standards for quality (which is good and will avoid a lot of nightmares), therefore, the biggest difference between the registered medicines like Sativex and those products will be therapeutic claims. The regulation doesn't mention any need of clinical studies and/or any sort of proof of efficacy or safety. Of course, they are welcome, but are not a pre-requisite for product registration.
On the other hand, they will not be able to be advertised as medicines, nor claim any particularly therapeutic effect. The clinical indication will be a decision of the physician (and the patient), based on product composition and available literature. Of course, is still a big advantage to conduct the studies and have proper therapeutic claims for a given product. I think it's "fair enough" and ANVISA found a good compromise between speed up the entrance of products into the market, while preserving quality.There are some details regarding the prescription depending on product composition an "CBD-based products" with lower than 0.2% THC will be allowed to any sort of patients (with prescription, valid for 60 days), while other compositions with higher THC levels will have a special type of prescriptions, comparable to morphine. It's probably too restrictive, but it's a good start for the first experience of a very conservative country with a right-wing government.
"One step further and you're no longer in the same place" says Chico Science, a Brazilian singer. I am an optimistic and I think this is was a bold step for the country.
It could 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.
The main objective of this Medium is to bring high-quality information regarding science and technology in Medical Cannabis, a blooming field in the last years. I am a cannabinoid pharmacologist who believed and studied therapeutic effects of cannabinoids since 2003 and it's nice to finally see it happens. One time or the other, we also risk to comment about the market and entrepreneurship here, because I believe that this is how things should be taken forward. Interested? Follow us to receive content in your mail or drop me a line at fabriciopamplona@gmail.com.
