The STF will define the criteria for the public provision of cannabis-derived medicines without marketing authorisation, but with exceptional health authorisation or import authorisation.
The dispute concerns four appeals (ARE 1,595,776, REs 1,597,033, 1,594,313 and 1,596,714) for which general repercussion has been recognised, although no date has yet been set for a ruling on the merits. The legal principle to be established is expected to guide other levels of the judiciary in similar cases.
In the proceedings, the Court is expected to determine the legal framework applicable to these products, the requirements for their judicial provision, and which court has jurisdiction to hear and decide such claims. The discussion involves the application of previous STF precedents concerning the State’s provision of medicines, including exceptional cases involving products without marketing authorisation but whose importation has been authorised by Anvisa.
When recognising general repercussion, Justice Edson Fachin noted that the issue has become more complex due to the expansion of the regulatory framework for cannabis-derived products, the diversity of formulations, the different types of health authorisation and the increasing number of legal claims involving the matter.
In addition, the growing number of state-level rules on the distribution or provision of these products reinforces the need for uniform criteria to be established by the STF.
MJAB Insights: The ruling is expected to be relevant to health-related litigation involving cannabis-derived medicines, particularly because it concerns products that do not have marketing authorisation but have some form of authorisation from Anvisa.
The central issue will be to determine when the public provision of these products may be legally required and which requirements must be demonstrated by the patient, such as clinical necessity, health or import authorisation, and the possible absence or inadequacy of available therapeutic alternatives.
The decision may also clarify which courts have jurisdiction to hear these claims and the allocation of funding responsibilities among the Federal Government, States and Municipalities, a recurring issue in healthcare litigation.
From a practical perspective, the legal principle established by the Court should provide greater predictability for patients, public authorities and legal practitioners, reducing divergent decisions and guiding the preparation of judicial claims involving cannabis-derived medicines.