Fraud of high-cost medicines without registration at ANVISA: brief analysis of concrete cases stimulated by the judicialization of health in Brazil

Abstract

It is known that in order to obtain medicines through justice, one of the requirements is that they are provided by the SUS and, mainly, approved by Anvisa. This requirement became even more essential after a thesis established by the Superior Court of Justice in 2018 and a recent decision by the Federal Supreme Court. That Superior Court established the obligation of the public authority to analyze the cumulativeness of three requirements for the supply of medicine not incorporated by SUS. Among them, the existence of registration of the drug in Anvisa rests. The STF plenum decided last May 22 that the State cannot be required to provide experimental medicine or without registration in Anvisa, except in exceptional cases. However, good faith was not always the guiding principle of these lawsuits. Frauds in the industry have not gone unnoticed. In these cases, Justice was only an instrument for the acquisition, via government, of drugs and high-cost inputs, not yet registered by Anvisa. A colossal extortion to the public coffers and to all the Brazilian society, like the one that had been triggered in police operations, like "Operation Asclepio and Operation Chalice of Higia".