Health buys insulin from a manufacturer not registered with Anvisa to guarantee treatment by SUS

The Ministry of Health acquired about 1.3 million quick-acting analogue insulin pens on an emergency basis. The item is used by patients with type 1 diabetes to stabilize the blood glucose level. The purchase was formalized on Tuesday (9) and is part of a series of measures adopted by the government to avoid shortages in the Unified Health System (SUS), which provides supplies to Brazilians undergoing treatment for the disease.

Since April, the portfolio has publicly recognized that it faces problems in supplying public network stocks. In a note, the agency even stated that it opened auctions for the purchase of insulin, but did not receive responses from suppliers. Manufacturers registered in Brazil would be unable to meet current demand.

On an emergency basis, the Ministry of Health opened a auction without bidding and acquired just over 1.3 million insulin tubes from the Chinese manufacturer Gan & Lee. This product is not registered in Brazil and does not have the approval of the National Health Surveillance Agency (Anvisa).

On the other hand, it is registered in countries with regulatory agencies that are part of the ICH (International Council for Harmonisation), as is the case in China. In emergency cases, Anvisa allows the government to resort to products registered with the ICH.

contract details

A CNN the coordinator of the Department of Public Health of the Brazilian Society of Diabetes (SBD), Karla Madeira, said that there is a lack of information about the insulin recently purchased by the Ministry of Health.

According to the specialist, who closely follows the case and has already participated in meetings with public bodies and manufacturers, it was not possible to attest, in Brazil, the safety and effectiveness of the insulin produced by Gan & Lee. “We were unable to identify comparative studies from a pharmacological or clinical point of view. These are recommendations for any biosimilar medicine such as insulins,” she said.

Another point raised by the SBD coordinator is that the entity did not have access to the report on good manufacturing practices for this drug, a document produced by Anvisa, which visits the production sites of the products that will be registered in the country.

Due to similar suspicions, the Instituto Diabetes Brasil stated that it had asked the Federal Public Ministry (MPF) to annul the emergency purchase process for insulin tubes carried out by the government. The institute argues that the health of patients with diabetes is being put at risk, since it is not possible to verify the quality of foreign insulin.

The contract signed by the Ministry of Health last week provides for the delivery of more than 1.3 million cans of insulin in two stages: 673 thousand tubes of 3 milliliters (mL) must be delivered in 60 days and another shipment with the same amount in 150 days. Each unit was purchased for around R$ 13.96. The total value of the contract is around R$ 18.8 million.

The Ministry of Health informs that the quantity ordered will be enough to serve more than 67 thousand patients in the country and that it maintains contact with the supplier company so that the delivery can be anticipated.

On the other hand, the Brazilian Society of Diabetes states that there are approximately 568,000 people with type 1 diabetes in Brazil and that it is estimated that 420,000 patients with the disease are treated by the SUS. The entity projects that Chinese-made insulins will be sufficient to meet demand for a period of three to four months, considering the history of demand.

A CNN contacted Novo Nordisk, an insulin supplier in previous trading sessions of the Ministry of Health. The company’s plant in Montes Claros (MG) is the largest insulin factory in Latin America. Even so, the company states, in a note, that it does not have the production capacity to meet the volume and period of demand from the federal government.

“In relation to the emergency purchase made by the government, Novo Nordisk made a proposal that was not accepted by the Ministry of Health, which opted for another supplier”, says the statement.

Gam & Lee was also approached and did not respond to the report so far.

In addition to the emergency purchase, the Ministry of Health states that it is taking other measures to provide the supply of fast-acting insulin analogue tubes in the SUS. The folder began to relocate the stock among the Brazilian states and authorized the purchase of insulin by the state health departments with reimbursement to the states. State procurement is facilitated by the smaller quantity demanded in each contract.

Supply by country

A CNN consulted the state health departments of the 27 federative units and notes that there is still no widespread shortage of insulin in the country. Tocantins and Piauí were the only states that reported shortages or low stocks of rapid-acting insulin analogue pens.

Pará and Bahia reported having carried out the acquisition of tubes for the citizens of their states and that stocks are full. The state of Goiás, on the other hand, says that it was strategically organized when it learned about the problem and guaranteed the supply of its stocks.

Santa Catarina said that it manages to guarantee the treatment of patients in the state until next month and expects to receive another 10,000 tubes due to the relocation that the Ministry of Health made between the states.

Pernambuco informed that insulin stocks are in a regular situation, but that it maintains a dialogue with the federal government and is aware of the possibility of shortages due to the production and supply difficulties of pharmaceutical companies.

In São Paulo, the stock guarantees the treatment of patients for another 45 days, which is within the normal range. The other states in the Southeast also do not report shortages.