Popular Action requests the suspension of the recent Technical Note 35/2023, issued by ANVISA, which has started to prohibit the importation of Cannabis in natura, flowers, and other parts of the plant
Recently, in July, ANVISA (Brazil’s National Health Surveillance Agency) published Technical Note No. 35/2023, which, by changing a previous understanding, started to prohibit the importation of cannabis in natura, flowers, and other parts of the plant, relying on three main arguments:
- Lack of robust scientific evidence to prove the safety of use;
- The validity of international drug control treaties to which Brazil is a signatory; and
- The risk of diversion for illicit purposes.
According to the new Technical Note, there will be a 60-day transition period to complete ongoing imports, and the import permits previously issued will be valid until September 20, 2023. Products derived from cannabis provided for in Technical Note No. 35/2023 continue to be authorized for medicinal use with a medical prescription.
As a result of this Technical Note, an individual filed a Popular Action against ANVISA, with a request for an injunction, seeking the suspension of the effects of Technical Note No. 35/2023. The case number 1070454-02.2023.4.01.3400 is currently pending before the 1st Federal Civil Court of the Judicial Section of the Federal District, and last Friday (July 21), a decision was issued to summon ANVISA to respond to the petitioner’s request for an injunction, which has not happened yet.
Considering the possibility of the erga omnes effects of the sentence in a Popular Action, the case becomes even more relevant: in Brazil, there is a considerable number of people who were already importing cannabis in natura, flowers, and other parts of the plant. Given the constant changes in regulations regarding cannabis for medicinal purposes, it is almost inevitable that the Judiciary will continue to be an arena for debate on the subject.
Our experience shows that these movements are also influenced by regulatory updates in other countries, which directly impact the debate on the subject in Brazil and the prospects of patients who use such products.
Therefore, our team of lawyers continues to monitor the different aspects of the topic – whether regulatory, at ANVISA, or contentious, in the Judiciary.
This material is for informational purposes only and should not be used in isolation to make decisions. Specific legal advice can be provided by one of our lawyers. Copyright is reserved for Kestener & Vieira Advogados.
