The Federal Regional Court (TRF) of the 1st Region, headquartered in Brasília, ordered the National Health Surveillance Agency (Anvisa) to refund an inspection fee paid in 2011 by a company that imports medical and hospital equipment. The amount is R$ 37 thousand.
The importer had requested that Anvisa analyze a factory in China, which would supply it with the equipment. With the inspection, it would be entitled to obtain the Certificate of Good Manufacturing and Control Practices. The fee amount was deposited on April 27, 2011 – today, for a similar request, it costs R$ 72.8 thousand.
Two years and four months having passed, Anvisa had still not analyzed the request. In the meantime, the company gave up negotiating with the Asian manufacturer and decided to give up the inspection and administratively request the refund of the fee. However, Anvisa refused to refund the amount, on the grounds that the inspection activity begins with the analysis of the application and is not tied to a specific purpose.
The company then decided to take the matter to the Judiciary. At first instance, the request was denied by the judge of the 22nd Federal Court of Brasília, Francisco Neves da Cunha. He understood that the refund of the fee was not appropriate since, in addition to the services rendered by Anvisa, it also funds routine inspection activities.
At the TRF of the 1st Region, however, the understanding was favorable to the company. The case rapporteur on the 7th Panel, Appellate Judge Hercules Fajoses, understood that, since in the case no concrete measures had been taken regarding the request, the fee should be refunded in full, updated by the Selic rate. He further ordered the payment of court costs, attorney’s fees and other procedural expenses. Anvisa did not make a statement in the records.
In his vote, the magistrate cited a decision of the Superior Court of Justice (REsp 1109286). In the judgment, the rapporteur, Justice Herman Benjamin, understood that the Health Surveillance Inspection Fee, “in the event of a request for renewal of registration of a similar medication before Anvisa, proves to be enforceable whenever concrete measures are triggered by the inspecting body”.
In the case analyzed by the STJ, however, the Justice considered that measures applicable to the case had been taken and that, for this reason, the fee would be enforceable, even if a request for withdrawal was expressed by the interested party before Anvisa’s final response.
According to the company’s attorney, Glauber Ortolan, partner at Lassori Advogados, the charging of the fee is supported by the legislation. However, he adds, it is only due if there is effective performance of the activity. “Anvisa took more than two years and did not even advance the administrative proceeding”, he says. “What determines the charging of the inspection fee is the effective performance of the activity and provided that concrete measures are taken by the inspecting body aiming at the examination of the request, which in fact did not occur”.
A specialist in regulatory law, the attorney Eduardo Nobre, partner at the firm Leite, Tosto e Barros, states that the decision may serve as a precedent for companies in the same situation. However, he highlights that in the proceeding Anvisa did not make a statement. “If Anvisa states in other proceedings that it had already given some kind of progress to the case, it may be that it falls under the STJ precedent and then the refund of the fee cannot be obtained”, he says.
Contacted by Valor, Anvisa informed by means of a note that “the decision is correct, but we will not make a statement for reasons of procedural strategy”.
To read on the Valor website, click here.
Source: Valor Econômico
← Back to blog