Judge orders Anvisa to allow medical cannabis products into Brazil

Since 2015, two cannabinoids—tetrahydrocannabinol (THC) and cannabidiol (CBD)—have been authorized for medical use under regulations issued by ANVISA, the Brazilian Health Regulatory Agency.

Relying almost entirely on imports, the medical use of cannabis-based products is constantly increasing, as evidenced by the growing number of marketing authorizations granted for cannabis-based products. ANVISA regulates and oversees cannabis-based products through two resolutions: 327/19 and 660/22.

Access that is sometimes decided in court

In the latest ruling issued by Judge Vera Lúcia Feil of the 4th Federal Court of Curitiba, ANVISA was ordered to authorize the sale of a cannabis-based product for medical purposes. The plaintiff company, which markets a CBD product, obtained the injunction on February 7.

In her ruling, the judge emphasized that authorization to import the product should be granted automatically, in accordance with the provisions of RDC 660/22, and that the company only learned of the product’s exclusion through a patient. When he looked up the name on the form, he could not find it.

The company states that it has entered into a commercial agreement to manufacture the product in the United States and that it is marketed in Brazil under its brand name, Mahara. It also claims that the import procedure fully complies with ANVISA regulations, which allow for the automatic issuance of an import authorization for products covered by those regulations. However, since December 2023, ANVISA has rejected all applications without providing any justification.

Judge Vera Lúcia Feil found that the company had demonstrated unlawful abuse of power on the part of ANVISA by rejecting Mahara’s applications for authorization without initiating formal proceedings or first notifying the company of the need to submit documents.

«The court’s decision has simply restored the possibility for patients to have their import authorization issued automatically, since, as of 2020, the company has been included in Anvisa’s technical note, which allows for the immediate issuance of an import authorization for its product,» said Ana Paula Rossi, CEO of Mahara.

Improving Access to Medical Cannabis in Brazil

Currently, there are Three Ways to Access Medical Cannabis in Brazil : through pharmacies, organizations, or imports. Brazil’s national public health system (SUS) has not yet established a policy for the distribution of cannabidiol-based products. However, initiatives currently underway in the National Congress aim to ensure that patients who need these therapies can access them through the SUS.

In the absence of a comprehensive national regulatory framework, several Brazilian states have taken the initiative to propose state-level bills to facilitate the availability of cannabis-based products within the SUS.

Most Brazilian states now have a law in place or are currently engaged in legislative discussions to enact one. In March 2020, the state of Pernambuco also issued the first license for cultivation cannabis for medical purposes. The Brazilian Superior Court of Justice has also approved the personal cultivation of cannabis for medical purposes.