Abrace will have the first laboratory in Brazil with an operating license for the production of medicinal Cannabis

Abrace (Associação Brasileira de Apoio Cannabis Esperança, Brazilian Association of Cannabis and Hope Support) was the first medical Cannabis association to carry out the entire manufacturing process of Cannabis-based products legally in Brazil, from planting, harvesting, drying, extraction and dilution to the formulation of products. These activities, even if they were in accordance with the law, were being carried out pursuant to an injunction. Recently, however, the action became final.

This means that there is no more room for resources and that the association is finally authorized by court decision to have its own laboratory for the manufacture of medical Cannabis from the plantation. To this end, Abrace must comply with a series of requirements made by Anvisa, the body responsible for regulating all medicinal Cannabis products in Brazil, through RDC 327/2019.

Currently, Abrace has 47,000 members and offers seven cannabis-based medicines. Due to a court decision, only members can apply to receive the  medicines. To become a member, you must first see a doctor and receive a diagnosis and prescription. The membership fee is used to finance the facilities, staff and production. Abrace also maintains a social program in which it grants free or partial annuity to those who cannot afford the costs and receive numerous patients via SUS.

Democratization of medical cannabis access

Abrace has created an innovative social model of democratization of access to cannabis-derived products for medicinal purposes. Since it was founded in 2014, the association maintains all operations with its own resources, including the works it will have to carry out to comply with Anvisa’s requirements. Funds are raised by members and through donations.

Cassiano Gomes, founder of Abrace, says that he has never turned a patient away from the association: “When we reached 5,000 members, it would have been great if it had stopped there. We had about 20 collaborators, our life would have been more peaceful, without attacks and accusations of being an industry disguised as an association. I could have stopped at 20,000 associates, when we had 100 employees, and I could stop now that we have 47,000 associates and 250 employees. But what would it be like if I said that from now on we are going to close the doors, that we are not going to register anyone anymore? Who would benefit from this?” he asks.

The main cannabinoid substances used for medicinal purposes are CBD and THC. CBD is indicated in the treatment of diseases such as Parkinson’s, multiple sclerosis, schizophrenia, epilepsy, chronic pain, among others. THC acts as a muscle relaxant and anti-inflammatory, with anticonvulsant, antidepressant and antihypertensive effects. In addition, it is a good ally in the treatment of cancer, alleviating the adverse effects of oncotherapy.

No wonder, data from Anvisa indicate that there has been a growth of more than 93% in demand for Cannabis-based medicines in Brazil in the last year. In view of this scenario, the victory of the civil lawsuit filed by Abrace plays a significant role both in advancing the regulation of the medical Cannabis market in the country and in maturing the debate on the recreational use of the plant, even more so at a time when the STF is voting on the decriminalization of marijuana possession (up to the publication of this article, there were five votes in favor and one against).

Laws and regulations

In July of this year, Anvisa published a Technical Note prohibiting the importation of Cannabis in natura, as well as flowers and parts of the plant (NT 35/2023), even for medicinal purposes. Until then, it was possible to import Cannabis flowers through a medical prescription. The flowers were then consumed via inhalation or through food preparation.

However, Anvisa understood that there was a high degree of risk of diversion of the use of medical Cannabis for illicit purposes, going against international drug control treaties to which Brazil is a signatory. With the new NT, current regulation of products no longer includes permission to use parts of the plant, even after the stabilization and drying process or even in scratched, crushed or pulverized forms.

For Cassiano, NT 35/2023 came as a response to a previous measure issued by Anvisa that was badly done, which is why they revoked it and opted for a complete ban on the use of the plant. He hopes, however, that Anvisa will come up with a new resolution that meets the demands of patients. And he remembers that Abrace came about after he himself made a culinary preparation with the plant and olive oil.

“It all started in 2013, when my mother developed a serious health condition. She was hospitalized for seven days with the help of respirators, the doctor said there was nothing more to do and sent her back home. But she couldn’t eat or sleep. I knew that Cannabis had the property of giving appetite and sleep. I bought marijuana, made it in the kitchen with olive oil and gave her a teaspoon. An hour later, she was washing the dishes,” he recalls.

To learn more about how Abrace works and the importance of decriminalizing marijuana possession for advancing the regulation of medicinal cannabis in Brazil today, read Lupa do Bem’s full interview with Cassiano Gomes, founder of the association:

LB – Abrace is the largest association of cannabis patients in Brazil, with nearly 50,000 members. How was the process of building the association?

After I saw the effect of Cannabis on my mother, I started to help the neighbors and the university staff. I was studying law at the time and saw that everyone had the same answer. That’s when I started to become an activist and dropped out of college because I couldn’t reconcile. We created Abrace in my house, where the headquarters are located until today and where we have the laboratory,  do the cultivation and quality assurance. And I started helping people.

First came 10, then 20, 30 people. When I reached 66, I had a breakdown and the mothers said they were going to help me, protect me, sue me… that’s when we founded the association, registered with the notary and with the Federal Revenue Service. From then on, it was just a struggle to nit stop, not be arrested and not have treatments prevented, since we use the Post Office to send Cannabis oils.

LB – The association can manufacture the medicines, but it cannot send them by post, is that it?

Yes! We cannot send our products by the Post Office, but we do. By the way, all associations send. There is a legal void here, because Abrace’s medicines are supplied with a simple prescription, which is the white prescription, not the blue prescription, with special control. However, Anvisa requires medicinal Cannabis medicines in Brazil to be under special control, with a blue or yellow prescription. And we were unable to fulfill that determination to the letter. That is why we have demanded that Anvisa be part of it. Anvisa needs to regulate so that associations can comply with the determinations.

LB – What is the difference between membership to a cannabis company?

Abrace is not for profit. There is an industry within the association that aims to guarantee and improve production, so that we can reduce the cost of the oil, which, in my opinion, could be around R$60-50 reais a bottle [today Abrace sells bottles between R$ $220 and 360]. However, we are not yet in a position to do that, because we have a laboratory and a pharmacy under construction. In fact, there are seven constructions currently happening, and the laboratory is standard B, which requires a negative atmosphere, a standard for the industry, which we were forced to follow by Anvisa. If I could, I would have followed the live pharmacy model, which is much cheaper, but we had no choice.

LB – Why is this association model an innovative social model?

Today Brazil has a different reality from other countries. We were able to implement a different, more social, democratic, non-profit model, because all the money raised is invested within the associations themselves, and this means that we can advance more and more, even without external capital, without investment by speculators or banks. There are about 50 Cannabis associations in Brazil, and our purpose is to increasingly democratize access, but only three are authorized by the Justice to make the medicine and supply it to members.

LB – Anvisa issued NT 35/2023 in July, which prohibits the importation of flowers or other parts of the plant, even for medicinal purposes, and has already been called upon by the courts to revoke the Technical Note. Why is it so difficult to regulate medical cannabis?

What happened is that a patient needed the flower, went to court, gained authorization to import the flower and the court forced Anvisa to issue a resolution on importing the flower. Anvisa did it, but it was done poorly, there were problems and they revoked it. Because people were selling medical prescriptions, advertising, entering parties with the prescription in hand along with the flower. Then he missed the start. There was this rush from the market, from people who like cannabis and want to use it socially. Now, we hope that Anvisa does it well this time.

LB – The discussion in Brazil about the use of Cannabis, whether medicinal or not, is still part of a moral debate around the plant, when it should already be settled that the debate is about social justice and public health. Could you talk a little about that?

Well, there are principles that are being broken. The main thing, in my opinion, is that the subject can do whatever he wants with himself. There is also the principle of reasonableness, where we have realized that the law causes more harm than protection. Society is paying a high price for this, as incarceration has exceeded limits and has caused crime to become trivial.

LB- In the case of the use of medicinal Cannabis, the debate should be focused mainly on scientific research…

For sure! Here at Abrace, we always value research. So much so that when we started, we prepared a research consent for every patient to sign. We baptized Abrace’s oil as a clinical trial. And we defined that the oils could not be sold to third parties, it was non-transferable. And all the doctors who were arriving there, in 2015, 2016, were researchers. We have already partnered with UFMG, UFMA, UFPB and several universities. We had 25 researches in progress. But at a certain point, Anvisa forbade us to continue, because we did not have research authorization. It was a shock for us! Because what is most said and claimed is that there is no research. And we know there is…

LB – Does Abrace do any activist work, political articulation in Congress, for example, to defend the use of Cannabis?

No! Abrace always acts on behalf of its members. I myself have left activism a little aside because I need to protect Abrace. We are the target of many attacks, including from politicians. They made a video of me, for example, it was a politician who posted it on social networks, the video had several cuts, they changed the context, they made collages saying that I am a drug dealer disguised as an ongoer, that I want to regulate and release the use of marijuana in Brazil.

LB – Several countries have already decriminalized marijuana. What can we learn from these countries?

The difference between medicinal and social use of marijuana today is the prescription. And the state of California, in the United States, made a law that allows the use of marijuana without a prescription, but it has to be purchased at dispensaries. That’s it. Almost all countries that have already decriminalized marijuana have decriminalized the user. And some countries have regulated the trader. Obviously there will continue to be people selling outside, illegally. But then you have to see it as a tax offense like any other, imposing a fine, but not throwing the person in jail, this is the big mistake in the legislation. It is punitive, discriminatory, racist and misogynistic, many women put themselves at risk for the love they have for their husbands…

LB – When the STF began to judge this question of size, how was the debate on medicinal Cannabis?

Well, mothers were always afraid to carry the oils, including entering hospitals, emergency areas. Because until 2018 there was no authorization for transportation. If he got on the plane, the federal police could charge him. And there were people who were actually charged. That is why there is a need for all substances to be regulated. This is the crux of the matter.

A patient who has Alzheimer’s and goes to Portugal [taking oil], for example… when she gets there, she won’t have a problem because it’s decriminalized, but if she’s caught in São Paulo, here the legislation specifies CBD, but not THC. .. “Ah, but this oil is from an association”, she can defend herself. “And the association, is it authorized to produce THC oil?”

So, everything could be a question of inspection, but the path given by legislation today is just to incarcerate. There are no limits for Law No. 11,343 and the STF is trying to define these limits. There’s a lot to do. And we are also in the middle of it all. There are more than 50 associations in Brazil that came together. We created UNACAM and held a weeklong meeting here in João Pessoa. Anvisa attended, the Public Prosecutor’s Office, OAB, and several politicians… And it was wonderful, because we got support to guarantee representation so that the laws are approved in Congress.

LB – In your opinion, what would be the best legal solution to this issue?

Today, in Brazil, you need the blue prescription to buy Cannabis at the pharmacy. But can we sell it? No! Why? “Because it’s bad for children”, they argue. But how so? If the kids are using it and it is saving them! “Ah, but it is not smoked”, they argue again. Okay, but we also have spray, we have a vaporizer. “Ah, but you cannot vape in certain places”, they argue. But you have to be able to! And the tax collected from the sale of Cannabis the government can revert to education and health. That would be ideal.

Basically, that’s what the STF is trying to establish. The STF will not only establish the amount of postage. It will also oblige the Chamber to make the law, regulating the use, commercialization and industrialization of the national Cannabis market. And then, probably, you should demand the medical prescription. Cancer patients, epilepsy, chronic pain, multiple sclerosis, amyotrophic sclerosis… there are many conditions that require vaporized or smoked use, in any case.

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