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

Abstract

It is known that, to obtain medicines through the courts, one of the requirements is that they be provided by the SUS and, above all, approved by Anvisa. This requirement became more essential after the thesis established by the Superior Court of Justice (STJ) in 2018 and a very recent decision by the Federal Supreme Court (STF). That Superior Court established the obligation of the public authority to examine the cumulative fulfilment of three requirements for the supply of medicine not incorporated by the SUS; among them lies the existence of registration of the drug with Anvisa. The plenary of the STF, in turn, decided last 22 May that the State cannot be compelled to provide experimental medicine, or medicine unregistered with Anvisa, save in exceptional cases. However, good faith was not always the guiding principle of these lawsuits. Frauds in the sector have not gone unnoticed. In such cases, the courts were merely an instrument for the acquisition, through the government, of high-cost drugs and inputs not yet registered by Anvisa: a colossal extortion of the public coffers and of the whole of Brazilian society, as shown by police operations such as Operação Asclépio and Operação Cálice de Higia.