Public health
Minister André Mendonça, of the Federal Supreme Court, ordered the resumption of bidding, promoted by the Ministry of Health, for the acquisition of the drug Alfaepoetin, indicated for the treatment of anemia and chronic renal failure.
Freepik
The rapporteur rejected the decision of the Federal Audit Court (TCU) that had suspended the bidding process and allowed the company to participate in the competition without having the medicine registered with the National Health Surveillance Agency (Anvisa).
The injunction was granted in a Writ of Mandamus presented by Blau Farmacêutica SA, a participant in the competition. The company claimed that the Chinese company Nanjing Pharmacare Co. Ltd., represented in Brazil by Auramedi Farmacêutica Eireli, does not have a health registration for the medicine with Anvisa, and requested the TCU for a precautionary measure to remove the requirement set out in the notice, in order to enable your participation in the electronic auction.
The author of the request stated that the TCU’s decision creates an exception not foreseen by Anvisa and violates the Brazilian legal framework, as it allowed the bidding to take place with the participation of a company without health registration of the medicine.
Public health protection
In a preliminary analysis of the case, Minister André Mendonça considered the TCU’s interference in the bidding procedure to be inappropriate. In his assessment, the exemption from registration with Anvisa for the supply of medication, without there being an exceptional situation, in addition to posing a risk to public health, appears to contravene health legislation (Laws 6,360/1976 and 8,080/1990).
Mendonça recalled that the jurisprudence of the STF (Theme 500 of the General Repercussion) understands that registration with Anvisa constitutes the requirement established by the Brazilian legislator for the protection of public health, attesting to the effectiveness, safety and quality of drugs sold in the country.
According to the minister, it is for this reason that companies that participate in bidding processes aimed at supplying medications within the scope of the Unified Health System (SUS) require registration.
The rapporteur also explained that the requirement can be waived in exceptional situations duly regulated by health authorities, but this is not the case in the case. In its view, when waiving registration, the TCU did not observe technical criteria in the health area, only considering the reasonable price charged in the market. With information from the press office of the Federal Supreme Court.
MS 39,592
