Health buys R$ 392 million in medicines without Anvisa registration – 05/23/2023 – Health

The Ministry of Health signed contracts worth R$ 392.2 million to purchase unregistered lots from Anvisa (National Health Surveillance Agency) of insulin and immunoglobulin, two drugs considered strategic for the SUS.

The folder says it was forced to look for the products outside the country due to the scarce stock and the difficulty of buying in the domestic market. It also states that it follows health legislation and requires, among other points, that the product be certified by regulatory agencies in other countries.

The Jair Bolsonaro (PL) government also resorted to purchasing immunoglobulin without the registration of the Brazilian agency. Although this procedure is not new, patient associations and physicians fear receiving unknown and low-quality drugs.

Anvisa grants the registrations after evaluating studies on the safety, quality and efficacy of the products, in addition to inspecting the facilities of pharmaceutical companies spread across several countries.

Coordinator of the Coalition Voices of Advocacy on Diabetes and Obesity, Vanessa Pirolo says that patients are “very concerned” because of the purchase of insulin. There is a fear, according to her, of which results or adverse reactions the product can demonstrate.

“Anvisa is a serious agency. We are confident when it gives approval for a medication”, says Pirolo.

Patients still fear that the ministry will repeat mistakes in purchases made with distributors, that is, that are not signed directly with pharmaceutical companies or official representatives.

In one of the most traumatic cases, Saúde tried to import, without the approval of Anvisa and the manufacturer, products for rare diseases. Purchased in 2017 and 2018, these drugs were never delivered by the contractor.

“That’s not the case [na compra atual]. We have contact with the company and the manufacturer,” he told Sheet Leandro Pinheiro Safatle, director of the Economic-Industrial Complex Department at the Ministry of Health.

For Safatle, difficulties in purchasing reinforce the need to invest in the national production of medicines, including through public laboratories.

Members of the Health privately acknowledge that there is already a lack of medication in some places, but they say that they act to reduce harm to patients.

Safatle claims that the federal government has authorized states to purchase insulin and claim reimbursement from the ministry; he also advised managers to relocate stocks to less-supplied locations.

The emergency contracts were endorsed by the TCU (Union Court of Auditors). The STF (Federal Supreme Court) still maintained the purchase of immunoglobulin. Imports await approval from Anvisa.

The discussion on the acquisition of unregistered medicines in Brazil is between 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 sanitary agency’s scrutiny.

According to industry insiders, the registration process and the commitment to monitor the product in the market can raise the sales price.

“Both in the case of immunoglobulin and insulin, we have producers in Brazil”, stated the executive president of Sindusfarma (Union of the Pharmaceutical Products Industry), Nelson Mussolini.

“We understand that, for the strengthening of the Health industrial complex, the regulatory rules of Anvisa must be followed. Importing products without registration puts the Brazilian population at risk”, declared Mussolini.

The most expensive unregistered purchase of immunoglobulin was split between two companies.

One of them, Auramedi, has little business with the Union. According to data from the transparency portal, the company received around BRL 21,000 in all contracts already signed with the federal government.

Now, the company based in Aparecida de Goiânia, Goiás, will deliver batches of immunoglobulin purchased by the government for R$ 285.8 million.

According to the company, the product is manufactured by the Chinese pharmaceutical company Nanjing Pharmacare, the same company that supplied most of the immunoglobulin purchased by the SUS in recent years, also in emergency contracts.

In addition, the company says it has a telephone service for patients with questions about the product or adverse reactions.

Another portion of the immunoglobulin, worth R$ 87.63 million, will be delivered by Prime Pharma LLC, represented in Brazil by the company Farma Medical, from Manaus, Amazonas.

In a note, the Brazilian company claims that it sold approximately R$ 70 million in immunoglobulin to federal, state and municipal hospitals in 2022. The product purchased by the Ministry of Health, according to the company, is manufactured by the Chinese laboratory Harbin Pacific, certified by local health agency.

Immunoglobulin is used, for example, in the treatment of people with the HIV virus and immunodeficiencies. Since 2018, the government has accumulated frustrated purchases and disputes in court and TCU over the product.

The purchase of fast-acting analogue insulin pens cost R$ 18.8 million.

Such as Sheet revealed, the government faces the risk of a lack of this product in the SUS, which even had lots discarded by the Bolsonaro government because of the end of validity.

Chosen for the contract, Globalx claims that the manufacturer of the drug used to control diabetes is the Chinese company Gan&Lee. The same pharmaceutical has another type of insulin registered in Brazil, glargine, in addition to a factory certified by Anvisa.

The insulin contract is signed by Freddy Rabbat, a businessman who also operates in the luxury goods market.

During the pandemic, the government distributed masks considered inefficient by Anvisa, purchased by another company represented by Rabbat.

In a note, Health says that it even opened an administrative process because of the contract for the masks, but considered that the company should not be penalized, “since the documentation in the case records unequivocally demonstrates that all broken items were replaced” .

Globalx states that it must request the registration of the insulin at Anvisa, in order to start regularly supplying the product to the SUS. On the same note, it denies irregularities in the supply of masks and says that there is no connection between these purchases.