中藥批發Business News

A billion-dollar dispute going on since December 2022 has knocked out the [Brazil’s] Ministry of Health's stock of immunoglobulin. Made from human blood, the substance improves patients' immunity.

The ministry stored around 50,000 vials in May, a volume that corresponds to the demand of around 30 days in the SUS (Unified Health System). In a technical note signed the following month, the ministry warned that it would run out of stock from July onwards, seriously affecting users' health and leading to "even a risk of death," according to the agency.

The ministry now says that the SUS will be supplied until the end of September, combining stocks from the federal government, state secretariats, and a purchase from the public company Hemobrás. The ministry also says it will reimburse states for immunoglobulin purchases.

The attempt to buy bottles for 2024 began at the end of the Bolsonaro administration. It was only unblocked in July this year, by a decision of Justice Kassio Nunes Marques, of the Supreme Federal Court (STF).

The judge overturned a ruling by the Federal Court of Accounts (TCU), which determined the inclusion of companies supplying medicines not registered by the National Health Surveillance Agency (Anvisa), provided they had been evaluated by one of the leading health regulatory agencies abroad.

Medicines without national registration are usually cheaper, an argument that motivated the TCU's decision. But buying a product that hasn't been approved by Anvisa is a measure criticized by the medical community and patient associations.

Ekaterini Simões Goudouris, scientific director of Asbai (Brazilian Association of Allergy and Immunology), says that Anvisa protocols must be followed to avoid contamination of the medicine made from blood plasma.

"There is a risk of disease transmission. That's our concern, and you're using this product for patients who already have an immune condition, so it's even riskier," she said.

Immunoglobulin is used for a number of clinical conditions, including HIV/Aids, primary immunodeficiency, Guillain-Barré syndrome, for patients who have had a transplant or in manifestations of SIM-P (Post-Covid Pediatric Inflammatory Syndrome).

In the decision that unblocked the ministry's purchase, Nunes Marques considered that it was necessary to follow the rules of the Brazilian agency. Anvisa only allows unregistered drugs to be distributed to the SUS in extreme cases, such as a shortage of the drug on the domestic market or public health emergencies.

Anvisa grants registrations to drugs after evaluating studies on safety, quality and efficacy, as well as inspecting the facilities of pharmaceutical companies in various countries.

After the STF minister's decision, the Ministry of Health tried to buy 817,000 Anvisa-registered vials at the end of July. The deal could have reached R$1.1 billion.

However, the government only managed to get offers within the maximum price (R$1,400) for around half of this volume (408,000 vials). Now, the ministry is adjusting the terms of the contracts in order to purchase this amount.

The price per unit in the purchase of the 408,000 vials should be higher than that observed (around R$1,000) in recent Health purchases for the unregistered product.

The amount to be purchased will still have up to 120 days to arrive in Brazil after the contract is signed with the suppliers. Health says it will negotiate delivery times to ensure stocks are maintained.

One of the selected companies, ASP, which supplies immunoglobulin manufactured by Ukrainian Biopharma, says it will try to bring forward the delivery of 32,000 vials to the end of September. "It's important to remember that once the product arrives in Brazil, the clearance processes involving customs, INCQS and Anvisa will take 30 days," said ASP.

The Spanish multinational Grifols, which will also be supplying the registered immunoglobulin, said that it will comply with the terms of the contract with Ministry of Health, but did not answer whether it intends to bring forward the delivery of the vials.

At the same time, the ministry closed the purchase of 213,000 vials from Hemobrás for R$1,593.86 per unit (R$340.4 million in total), but the delivery of these batches will also be made in installments.

The public company is the only one authorized to use the plasma collected in Brazil to produce medicines. Part of the process, however, is carried out by a private pharmaceutical company in Europe, while the national factory is being built.

Goudouris says that it is advantageous to use the product made from blood collected in Brazil, because it can contain antibodies adapted to infections that are more common in the country. "We still have broader vaccination coverage than other countries, so this is undoubtedly a plus," he said.

In a statement, the ministry said that it has started to monitor immunoglobulin stocks across the country on a fortnightly basis. The ministry also stated that it is working to strengthen national production of the product, "as a structuring action that will reduce the vulnerability of the SUS and guarantee national sovereignty".

Since at least 2018, the federal government has been trying to buy immunoglobulin in court disputes and threatening SUS stocks. In the meantime, the ministry has signed several contracts with companies without a registered product in Brazil to avoid shortages or to comply with TCU decisions.

China's Nanjing Pharmacare was the main supplier of the drug without Anvisa registration. In a statement released last year, the ministry said that the company is global and serves the domestic market in China, the United States, Canada, Mexico, Japan, India and other countries.

In 2023, another company that supplied the ministry with an unregistered product was Prime Pharma LLC, which had around 30,000 bottles banned by Anvisa. This was because the batches valued at around R$30 million arrived in Brazil without the equipment used to monitor temperature variations during transportation. Saúde did not pay for the product.

The industry based in Brazil is against the distribution of unregistered products to the SUS. The sector believes that the dispute is made unequal by allowing companies that have not had to undergo Anvisa's evaluations and government price controls to enter, among other national requirements.

Nunes Marques' decision in favor of the products registered by the regulatory agency was given in a case brought by the Brazilian pharmaceutical company Blau. In that case, the MPF and the Ministry of Health also argued for excluding companies that supply products without Anvisa's approval.

Blau even took part in the Ministry of Health's most recent tender but presented values above those sought by the government and was not selected.

The TCU is still trying to reverse the STF's decision and reinstate unregistered products in the Ministry of Health's tenders.

Source: https://jornaldebrasilia.com.br/noticias/brasil/compra-bilionaria-se-arrasta-e-reduz-estoque-de-imunoglobulina-do-sus/