Anvisa orders the destruction of a batch of R$ 30 million of immunoglobulin – 10/20/2023 – Balance and Health

Anvisa (National Health Surveillance Agency) banned a batch of immunoglobulin valued at around R$30 million purchased by the Ministry of Health to supply the SUS (Unified Health System).

The agency states that around 30,000 vials of the medicine, made from blood plasma, arrived in Brazil without the equipment used to monitor temperature variations during transport.

The ministry did not pay for the batch and says that current stocks of immunoglobulin are satisfactory. “The supply of SUS with products whose quality has been certified and assistance to patients who depend on treatment will not be interrupted as a result of the process”, states the ministry in a note.

The agency’s technical area ordered the destruction of around half of the lot after inspections carried out on Wednesday (18) and Thursday (19). The rest of the cargo must be returned.

The ban can be reversed if the agency accepts an administrative appeal or by a possible court decision.

The ministry signed contracts worth around R$370 million, in April, to purchase immunoglobulin with two companies that do not have products certified by Anvisa. The ministry argues that it made emergency purchases after frustrated attempts to purchase products validated by the agency, decisions by the TCU (Federal Audit Court) and to avoid shortages.

The medicine is considered strategic for the SUS, as it can be used to treat various diseases, including AIDS and other immunodeficiencies.

The banned batch is the first delivery made, late, by Prime Pharma LLC, from the United Arab Emirates, which is represented in Brazil by the company Farma Medical, from Manaus.

The companies signed a contract worth R$87.6 million to distribute 90,000 vials. The medicines were manufactured by the Chinese laboratory Harbin Pacific.

Farma Medical denied irregularities and said that the medicines were transported in a cold chain, with “temperature control guaranteed contractually and by the refrigerated container equipment used by the company [aérea]”.

The company said it will appeal and, if necessary, take legal action to reverse the ban.

Farma Medical also stated that the merchandise arrived in Brazil at the correct temperature and could remain out of refrigeration for up to 3 months.

“The shipping procedures adopted by the manufacturer are in accordance with international transport standards and guaranteed by contract and monitoring carried out by the airline that specializes in this type of transport,” said the company.

Farma Medical has already made smaller sales of immunoglobulin to the SUS. It received around R$4.5 million for deliveries to Armed Forces and university hospitals in 2022 and 2023.

The Ministry of Health states that it demanded explanations and notified the company. This is a first step towards the possible opening of an administrative process to determine whether there was an irregularity in the service of Prime Pharma and Farma Medical.

“The justifications and documents provided by the company were filed by the department with Anvisa. It is worth noting that there was no transfer of resources to the company”, states Saúde.

In the “interdiction term” for 16,200 bottles, the Anvisa inspector states that “the destruction of the product was motivated by the lack of temperature monitoring of the biological product, and the impossibility of certifying its safety and effectiveness”. The document gives the contracted company 30 days to incinerate the product.

Anvisa rules determine that thermolabile medicines, sensitive to temperature variations, must be stored and transported with caution. In the case of immunoglobulin, the acceptable temperature range is between about 4 and 6 degrees.

The agency also requires product monitoring throughout transportation. Therefore, companies often use equipment known as a “data logger”, which records changes.

The device is a type of thermometer with memory to store the measured variations. It can be attached to medication boxes, and the data can be read after delivery.

Guilherme Favetti, lawyer for Farma Medical, said that “there is no express provision to require a data logger”. “The packaging of the medicine was strictly monitored in the cold chain. There were no irregularities,” he said.

Saúde asked the company for explanations about the lack of equipment on the 16th, citing Anvisa’s resolution that requires the presentation of “continuous temperature records” during transport.

Health members who followed the case state, with reservations, that the department should not insist on the release of the cargo, as there is no risk of shortages.

At least since 2018, the federal government has been accumulating frustrated purchases and disputes in court and in the TCU over immunoglobulin.

In recent years, the department closed contracts worth more than R$300 million for medicines not registered by Anvisa, made with foreign plasma. The products, however, are certified by agencies in other countries.

Although this procedure is not new, patient associations and doctors fear receiving unknown and low-quality medicines. The discussion about the acquisition of unregistered medicines in Brazil opposes the government and the national industry, which claims to be harmed by disputing contracts with importers who did not have to submit the product to the health agency’s scrutiny.

The difficulty in supplying the SUS is one of the arguments cited by supporters of the PEC (proposed amendment to the Constitution) that allows the sale of blood plasma, approved by a Senate committee at the beginning of October.

The Ministry of Health opposes the text. In addition to pointing out a health risk, the ministry states that the state-owned Hemobrás factory, located in Goiana (PE), should be ready in 2025. This unit should allow the fractionation of plasma collected in Brazil, which is now sent abroad to produce medicines for SUS.