Request for cannabis-based medicine without registration at Anvisa must be judged by the Federal Court

Actions requesting the supply of cannabis-derived medicines, still without registration at the National Health Surveillance Agency (Anvisa), must be filed against the Union. Therefore, the competence to process and judge these cases lies with the Federal Court.

The understanding was established by the Second Section of the Superior Court of Justice (STJ) when judging a jurisdictional conflict between a federal court and a state court in Santa Catarina.

A similar situation was recently judged by the 5th Civil Chamber of the Paraná State Court of Justice (TJPR). On that occasion, the court also understood that the absence of product registration at Anvisa transfers jurisdiction to the Federal Court.

Conflict between Federal and State Courts

In the case analyzed by the STJ, the request to obtain the plant derivative was initially submitted to the Federal Court. The federal court declined jurisdiction, arguing that the situation did not fit within Theme 1,234 of the Supreme Federal Court (STF), which deals with federal jurisdiction for drug supply.

On the other hand, the state court referred the case to the STJ, arguing for the application of Theme 500 of the STF. This thesis establishes that actions seeking drugs without Anvisa registration must be brought against the Union.

STJ's Grounds

The rapporteur of the conflict, Minister Afrânio Vilela, emphasized that the requested medication can be imported, even without Anvisa registration, via RDC 660 which establishes criteria for the importation of cannabis-based products by individuals with a medical prescription. Therefore, the case does not fall under Theme 1,234 of the STF, which deals with drugs already registered by the agency.

He also pointed out that Themes 793 and 1,161 of the STF — which address the joint responsibility of federal entities in health care and the supply of unregistered drugs, but with authorized importation — do not apply to jurisdictional conflicts, as they concern the merits of the actions.

“The consolidated jurisprudence of this STJ understands, in light of Theme 500 of the STF, that actions seeking the supply of drugs not registered at Anvisa, as is the case here, must necessarily be brought against the Union, thus attracting the competence of the Federal Court to process and judge them,” the minister stated in an STJ note.