Regulatory progress, responsibility, and innovation: the journey of a Start-Up in the psilocybin landscape in Brazil

Written by Cesar Camara, MD, PhD

In Brazil, the debate on the use of psychedelic substances for therapeutic purposes has been gaining momentum — among them is psilocybin, the active compound found in several mushrooms of the Psilocybe Cubensis genus. At the same time, health and judicial authorities face the challenge of coordinating regulation, control, and innovation amid the growing number of requests to use these substances for therapeutic and scientific purposes.

Health regulation in Brazil for psilocybin

Brazil’s health regulation has incorporated the entirety of international drug conventions into national law, and established that the National Health Surveillance Agency (ANVISA) as the institution responsible for deciding what must be considered a drug when the Executive Branch has not passed specific legislation.

Because of this, Brazil is also subject to and fully adheres to the UN international drug control system, the NDS system, which is managed domestically by ANVISA.

As ANVISA is empowered to define what is or is not a drug, it has the authority to classify substances on a list that determines the level of control to be exercised — without the need for new laws from the Executive Branch. This is very similar to what happens in other countries in the Americas and Europe.

In this context, psilocybin and psilocin are listed in List F2, categorised as “Proscribed Substances,” similar to cocaine and heroin. As with all substances in this category, ANVISA formally considers them to have extremely high potential for abuse or harm.

Thus, any study or initiative involving these substances inevitably faces bureaucracy designed to prevent their use, in addition to prejudice, misinformation, and fear on the part of the regulator — who is still largely unaware of the low or nonexistent potential for abuse, dependence, or harm associated with psilocybin or psilocin, as demonstrated by scientific studies published by leading universities worldwide.

Curiously, ANVISA also maintains a list of proscribed plants and fungi in its List E, reproduced below:

1. Cannabis sativa L.

2. Claviceps paspali

3. Datura suaveolens

4. Erythroxylum coca

5. Lophophora williamsii (peyote)

6. Mitragyna speciosa (kratom)

7. Papaver somniferum

8. Prestonia amazonica

9. Salvia divinorum

Notice that the main psilocybin-producing mushroom (native to Brazil), Psilocybe cubensis, is not included in List E.

This omission has led hundreds of mushroom growers across Brazil, for years, to cultivate cubensis under the belief that their activity is not prohibited. The same omission has resulted in numerous international publications mistakenly describing Brazil as a country where cultivation, sale, and use of psychedelic mushrooms is legal.

The truth, however, is harsher. What actually exists is merely tolerance from law enforcement, which is now coming to an end because numerous growers — influenced by ANVISA’s statements that any activity other than observing the mushroom in nature is illegal — have been arrested and convicted for drug trafficking.

A war won without firing a single shot

One of the most active start-ups in this field in Brazil is Biocase, a biopharmaceutical company that has been developing a psilocybin active pharmaceutical ingredient (API) for three years and is about to enter the clinical stage. The start-up also works in the clinical care field, with a clinic licensed for intravenous and intranasal ketamine use, and in formal education, offering a postgraduate program titled “Psychedelic-Assisted Psychotherapy."

Even under the most restrictive classifications, medicinal and scientific use is guaranteed by law. However, despite obtaining all authorisations needed for full development of an API (IBTP23) and an experimental medicine (BT23), Biocase had still not identified the proper regulatory pathway for carrying out the academic study with in natura fungi.

Some other initiatives, understandably dissatisfied with ANVISA’s refusals for similar studies, decided to take legal action against the Agency to obtain these authorisations.

Believing this path would not be fruitful, Biocase concluded that the main reason for denials was the absence of sanitary regulations allowing the purchase, cultivation, or commercialisation of psilocybin mushrooms within Brazil. However, there would be no regulatory, legal, or ethical obstacle if a request were made for a project already approved by Brazil’s ethics system, asking ANVISA for “plant material” for the project.

In this way, Biocase obtained ANVISA’s authorisation to import 18 kg of dried Psilocybe cubensis mushrooms for pharmaceutical production of a pilot batch aimed at registering a medicine in Brazil.

Still, they had not yet obtained authorisation to conduct their academic study with dried mushrooms. To move forward, they submitted a request emphasising that science is not as prohibited as proscribed-substance use is; that they were affiliated with a university duly approved by the Brazilian government; that the study was approved by ethics committees; and that the mushroom, just like in the 18-kg authorisation, is not included on the list of prohibited “plants.” For imprisoned cultivators this fact offered no help — but for their project it was essential: if the fungus were formally listed among prohibited “plants,” there could have been administrative challenges regarding the legality of importing it in natura into Brazil (as happens with cannabis, which ANVISA has always refused).

After ten months of intense discussion within ANVISA’s administrative electronic system, the study was authorised.