Court orders Anvisa to allow entry of cannabis flowers into Brazil

By Sechat editorial team

The court has determined that the National Health Surveillance Agency (Anvisa) must allow, by September 27, the entry into the country of products and medications containing the cannabinoids THC and CBD as active ingredients for medicinal purposes. The decision from the 16th Federal Court of the Federal District includes, for example, concentrated products and raw cannabis flowers. 

According to lawyer, Max Warner, who is responsible for one of the lawsuits against Anvisa for the revocation of Technical Note 35/2023, which resulted in the prohibition of cannabis flower imports in July 2023, the court decision is unappealable.

Prohibiting patients' access to cannabis flowers is an attack on the constitutional right to health access.

lawyer Max Warner

“Regarding the decision, Anvisa has already indicated that it will state that it has not violated the ruling issued by the 16th Federal Court that required it to authorize the importation, for medicinal purposes, of products and medications based on THC and CBD, since, in the Agency's view, cannabis flowers cannot be considered a 'product' or 'medication'. This is extremely controversial, as all the hundreds of cannabis-based products and medications that have been authorized by ANVISA for importation have been extracted from the flowers, as all cannabinoids are found in them. Finally, I think it is important to highlight that there is no appeal to the second instance of this decision, but Anvisa may make such a claim to the judge of the 16th Federal Court,” he analyzes.

Understand the case: Anvisa prohibits the importation of raw cannabis flowers or parts of the plant 

On July 19, Anvisa released NT 35/2023, which announced the decision to prohibit the importation of cannabis flowers by individuals. In the note, it emphasizes that the current regulation of cannabis products in the country does not allow the use of parts of the plant, even after the stabilization and drying process, or in their shredded, ground, or powdered forms.

Read more: Anvisa clarifies prohibition of cannabis flowers to the Justice 

At the time, Anvisa claimed that the prohibition was based on the lack of robust scientific evidence proving the safety of using raw cannabis plants. The agency also argued that it considered the high risk of diversion of the flowers for illicit purposes, as there was no way to ensure the medicinal use of the raw parts of the plant. 

However, Warner refutes Anvisa's arguments and states that there are cases of diversion of purpose for other types of medications, yet the agency does not decide to prohibit them. According to the lawyer, diversion of purpose is not corrected by prohibition but by oversight. 

“This argument makes no sense. For example, let's cite medication for the treatment of attention deficit hyperactivity disorder – ADHD, Venvanse. Many young people are using this medication at parties and nightclubs to enhance the effects of alcohol and stay awake for longer, and yet Anvisa does not prohibit it. Anvisa needs to oversee doctors' prescriptions and the diversion of purpose, instead of simply prohibiting, at the risk of leaving thousands of patients without assistance who, through treatment with flowers, can control crisis moments,” he states. 

Anvisa has stated that it is within the deadline to respond to the court decision. See the case against Anvisa: