STF debates legal nature and rules for the supply of cannabidiol

The Supreme Federal Court (STF) has intensified the analysis of cases involving the demand for cannabis-based products through judicial means. The central focus of the discussions is to establish clear criteria for the supply of cannabidiol.

Although the Court has already established requirements in Theme 1,161 of General Repercussion, there still persists a technical divergence among the ministers. The debate revolves around the classification of the item: whether it is legally a "medicine" or just a "product of interest to health".

This distinction is crucial for funding rules. The final definition will establish how access and supply of cannabidiol will occur through the Unified Health System (SUS).

Financial impact on the supply of cannabidiol

The discussion directly influences the application of Theme 1,234, which defines the responsibility for the payment of health demands. If strictly classified as a "product" — similar to orthoses and prostheses —, funding may undergo changes in the rules of solidarity financing between the Union and States.

Recent decisions show varied understandings on the subject. While some judgments classify the item as a product subject to Anvisa import authorization, others treat it as an essential medicine. In severe cases, the courts have ensured immediate access to the supply of cannabidiol.

Judicial criteria required for cannabidiol

For judicial approval, the STF has established that the patient must meet four cumulative requirements. It is necessary to have Anvisa authorization for importation (if there is no registration) and to prove financial incapacity.

In addition, a medical report justifying the indispensability of the treatment is required. Finally, it is necessary to demonstrate the absence of a therapeutic alternative in the public network to justify the supply of cannabidiol.

The cost of treatment also determines the judicial competence. Actions with an annual value equal to or greater than 210 minimum wages are processed in the Federal Court, using the Maximum Price for Government Sales (PMVG) as a reference.

State scenario of cannabidiol supply

At the administrative level, the offer is advancing heterogeneously in the states. In the Federal District and Maranhão, the service is already standardized, but restricted exclusively to the treatment of refractory epilepsy.

Rio de Janeiro has enacted Law No. 10,201/2023, which provides for free distribution. However, the actual provision of cannabidiol still depends on the definition of Clinical Protocols and Therapeutic Guidelines (PCDT) by the State Department of Health.

With information from Rio de Janeiro State Court