On April 25, 2018, the Superior Federal Court (“STJ) ruled that Brazilian Courts may only grant to Brazilian patients the provision of drugs that are not within the list of drugs distributed by SUS if the following requirements are met:
(i) Registration of the drug with ANVISA;
(ii) Proven need by the patient, through a medical report about the drug and that the treatments provided by SUS are not effective; and
(iii) Proven lack of financial capacity by the patient to bear the cost of the prescribed drug.
This decision has been rendered under the system of multiple appeals dealing with the same matter of law (in Portuguese, “Recurso Repetitivo”), under which the decision becomes a binding precedent that must be followed by all Courts. This decision represents a major change in the case law related to the provision of drugs by the Brazilian Government, since Brazilian Courts are supposed to follow the requirements established in this precedent when deciding such cases.
Note, however, that there is a case pending before the Superior Constitutional Court (“STF) on the same issue, which may change the precedent established by the STJ.
For further information, please contact:
+55 11 3799 8208
+55 11 3799 8105
+55 11 3799 8256