The Ukrainian state laboratory Indar was one of those responsible for supplying insulin to the Unified Health System (SUS), thanks to a contract signed in 2013.
The agreement, however, was finalized last year, according to the ministry informed CNN on Thursday (3).
With this, the partnership also puts an end to a technology transfer agreement for the national production of the drug – a fact of which the Brazilian laboratory involved in the action claims to have no knowledge -, which would make Brazil less dependent on foreign inputs and knowledge and would make it possible to reduce imports. However, the Ministry of Health says there is no risk of shortages.
The supply occurred through importation made by Bahiafarma. The body, part of the structure of the government of Bahia, showed that it was not aware of the termination of the contract, which took place in 2021 and guaranteed that the partnership remains in force.
Last Monday (28), the municipality sent in a note the following explanation:
“The partnership between Bahiafarma and the Ukrainian laboratory Indar remains in force, and we currently supply human insulins to the Ministry of Health through a public tender”, says an excerpt from the position.
Also in a note, the MS guarantees that “the contract with Bahiafarma, whose supplier of the drug is the Ukrainian company INDAR, was finalized last year”. And despite the end of the partnership, the Ministry of Health states that “insulin supply in the Unified Health System (SUS) is regular throughout the country, with coverage until April 2023, from the contract signed with the company Novo Nordisk” (Danish laboratory).
However, despite being questioned, the ministry did not explain how it plans to make the national production of insulin and thus complete the interrupted technology transfer.
The Ministry of Health limited itself to saying that the technology transfer agreement was canceled because it “does not fit into the new regulatory framework for Partnerships for Productive Development, published in 2014”.
Originally, the partnership between the Ukrainian laboratory Indar was with the Oswaldo Cruz Foundation (Fiocruz), through the Institute of Technology in Fármacos (Farmanguinhos), with which the technology transfer agreement had been signed, through a Productive Development Partnership (PDP). ).
According to the National Health Surveillance Agency (Anvisa), Indar’s certification was renewed on January 22 this year. Thus, the laboratory is qualified, from a sanitary point of view, to continue exporting insulin to Brazil. The document is valid until January 24, 2024.
Insulin is a drug used to treat diabetes. According to the Atlas of the International Diabetes Federation, the country has 16.8 million adults with the disease. Number that places it in the fifth position in the world, behind only China, India, USA and Pakistan.
technology transfer
The agreement sought to make Brazil capable of producing recombinant human insulin to supply the SUS and reduce imports.
However, in 2017, the PDP was transferred from Fiocruz to Bahiafarma by the Ministry of Health. When contacted, Fiocruz reported that, by 2016, Farmanguinhos had completed three of the five stages of technology transfer and had reached production capacity on a laboratory scale.
“The third stage consisted of the incorporation of all the processes related to the production of the active pharmaceutical ingredient (API) for the production of recombinant insulin”, informed Farmanguinhos.
The last two stages were, according to the federal laboratory, related to the installation of the factory. In August 2020, the government of Bahia announced that the then newly created Companhia Baiana de Insulina would build the first insulin production plant in the southern hemisphere in the state, with an investment of BRL 200 million.
According to Fiocruz, after the transfer of the partnership, the foundation “had been collaborating technically until 2021, with the laboratory in Bahia, according to an agreement with the Ministry of Health”.
On the subject, again, Bahiafarma showed that it was not aware of the cancellation of the agreement. “As for the PDP project between Bahiafarma and Indar, we are currently awaiting a positive decision from the Ministry of Health regarding the continuity of the project so that the actions for the formation of Companhia Baiana de Insulina and the construction of the factory can be continued” , the agency said.
However, CNN found that the agreement was canceled by the Deliberative Committee of the Ministry of Health that evaluates the PDPs, which was confirmed to CNN by the body and reiterated by Fiocruz.
What does the Ministry of Health say?
Read the full note from the folder on the subject:
“The Ministry of Health informs that the supply of insulin in the Unified Health System (SUS) is regular throughout the country, with coverage until April 2023, from the contract signed with the company Novo Nordisk. The contract with Bahiafarma, whose supplier of the drug is the Ukrainian company INDAR, was finalized last year.”
Source: CNN Brasil
