RIO DE JANEIRO, BRAZIL – The Federal Supreme Court (STF) has ruled that it is the State’s duty to supply drugs that, although not registered with the Brazilian Health Regulatory Agency (ANVISA), have their importation authorized by the body.
The Court’s ruling is applicable whenever the patient proves economic incapacity, the indispensability of the treatment, and the impossibility of replacing it for another drug provided by the National Health System (SUS).
Cannabidiol
The decision was reached in an online session closed on June 18, with the ruling becoming a “general repercussion” case, i.e. one where the STF determines that the decision should serve as precedent for all similar cases in Brazilian courts.
The lawsuit, filed by the State of São Paulo, reached the Supreme Court after the State Court of Appeals (TJ-SP) confirmed a lower court decision and ordered the supply of cannabidiol-based medication to a minor patient suffering from chronic encephalopathy caused by congenital cytomegalovirus and untreatable epilepsy, with severe and frequent seizures.
The TJ decision took into account the patient’s financial vulnerability and the fact that the drug, albeit not registered at ANVISA, was authorized for importation by the agency.
In this case, ANVISA had authorized the drug to be imported on an exceptional basis, for the individual’s own use, upon prescription from a legally qualified professional.
A medical report attached to the case further attests that the patient has already undergone all available medications on the domestic market, with no success in controlling the epileptic seizures.
To the STF, the State of São Paulo argued that the absence of ANVISA registration should prevent the obligatory supply of the product.
The patient’s attorney argued that the drug had been prescribed by a medical professional as the only possible means of treatment and that after using cannabidiol, seizures declined from some 80 a day to 4 or 5.
Import authorized
The rapporteur of the case, Justice Marco Aurélio, voted to dismiss the case, holding that it is the State’s duty to pay for any drug that, albeit not registered at ANVISA, has its importation authorized.
However, Justice Alexandre de Moraes’ subsequent vote, which expanded the list of conditions needed for the obligatory supply of such drugs, utltimately prevailed.
According to de Moraes’ opinon, the State will be responsible for providing the drug in exceptional cases, if in addition to its importation authorized by ANVISA, the patient proves economic incapacity, as well as the clinical indispensability of the treatment and the impossibility of replacing it with a similar drug included in the official medication list and in the SUS therapeutic intervention protocols.
Justices Dias Toffoli, Ricardo Lewandowski, Gilmar Mendes, Luiz Fux, Roberto Barroso, Cármen Lúcia and Rosa Weber all concurred with the opinion of de Moraes.
In dissent, Justice Edson Fachin followed the reporting justice, while Justice Nunes Marques opined that the case has peculiarities that make it impossible to govern future cases.
Medicinal purposes
Both the rapporteur and Justice Alexandre de Moraes stressed that the importation of cannabidiol is authorized by ANVISA and that Resolution RDC 17/2015 establishes the procedures to authorize companies to manufacture and import, as well as requirements related to marketing, prescription, dispensing, monitoring and surveillance for medicinal purposes.
Thus, the fact that products are not on the SUS’ official medicinal list and therapeutic intervention protocols, does not prevent public authorities from providing them to those who do not have the means to finance the treatment of the disease.
Justice Alexandre de Moraes noted that, in judgments of other appeals on similar issues (Themes 500 and 6 of general repercussion cases), the STF has defined the same premises for the supply of drugs not included in the SUS lists, despite the peculiarities of each case.
He also added that the Federal Constitution (Article 227) enshrines the protection of children and adolescents as one of the fundamental values with absolute priority, and that the State, family and society are responsible for ensuring them, among others, the right to health.
Precedent
The general repercussion precedent was defined as follows: “The State is responsible for providing, on an exceptional basis, a medication that, albeit not registered with ANVISA, has its importation authorized by the regulatory agency, provided that the patient’s economic incapacity, the treatment’s clinical indispensability, and the impossibility of replacement by another similar medication contained in the official medication dispense lists and the SUS therapeutic intervention protocols, are all evidenced.”