KYIV. July 20 (Interfax-Ukraine) – The leadership of the State Service of Ukraine on Medicines and Drugs Control is displacing the laboratory of the Marzieiev Institute from the medicine quality control market, laboratory head Natalia Ostanina said.

"They are trying to accuse us of being incompetent, of falsifying data, of not being an authorized laboratory on our Ukrainian market. We see that our laboratory is gradually being forced out of our market. We do not receive any directions, although for 28 years in a row we have worked with the Ukraine's Service on Medicines, and with authorized agencies, with the Health Ministry, the Security Service of Ukraine, the police and other competent authorities," she said at a press conference at Interfax-Ukraine on Friday.

Ostanina said the laboratory has been working in the medicine quality control market for more than 27 years, is accredited according to ISO international standards, including WHO, conducts scientific activities, is equipped with modern equipment, and also has a vivarium in its structure, which allows us to guarantee accurate research in accordance with international standards.

She said the laboratory, which is part of the state institution of the National Academy of Medical Sciences of Ukraine, which employs more than 40 people, receives funding for only 15 employees, the rest are financed under economic contracts. However, she has not recently received orders to conduct such research.

According to Ostanina, in August last year a completely new laboratory appeared on the market, which received authority literally two weeks after its appearance.

"From the moment our laboratory stopped receiving referrals for quality control from the State Service on Medicines, we started to receive feedback. Everyone who was redirected to this new laboratory returned to us with a request for assistance in conducting research – in the newly created laboratory there was no standards, no chemicals," she said.

Ostanina said since logistics in the country are disrupted, purchasing many standard substances today is very difficult and takes a long time (more than 30-60 days for delivery).

"We sympathetically handed over the standards from our archive of the institute and some chemical substances, understanding that without this it is impossible to carry out quality control of medicines in our country, and our citizens will lose many drugs on our market," the expert said.

According to her, "all heads of departments that are associated with quality control of medicines are apparently interested in ensuring that referrals do not go to our laboratory."

At the same time, Ostanina did not name the list of medicines in question. She just said this is about Dobrobut Likylab LLC.

The manager also said that an investigation had been launched against the laboratory. There is a court ruling, which states that allegedly during the investigation it was established that the laboratory of the Marzieiev State Institute of Public Health is abusing her official position and, together with authorized persons of a number of business entities, has introduced a scheme for the sale of low-quality medicines in order to make a profit for herself, contrary to the interests of a state institution.

"We are accused of falsifying studies of medicinal products that the laboratory never conducted (...) As for the medicinal products that were tested by us, absolutely all documents and original journals of analytical chemists, all primary data on the analysis, were confiscated, copies of job descriptions for working personnel, etc. I think that law enforcement agencies will sort it out and prove who is right and who is wrong," she said.

Ostanina said "the leadership of the State Service on Medicines, having learned about plans to hold a press conference, scares us that they are ready to remove us from the list of authorized laboratories."

"The State Service on Medicines believes that, by law, only they have the right to decide where to send a drug for quality control, without taking into account the capabilities of authorized laboratories. I would not trust new private, newly created laboratories that have not confirmed their competence in any way except by receiving authority from State Service on Medicines. This is, after all, state control of the quality of medicines. We will write an open letter to the presidential administration, the President of Ukraine, the Cabinet of Ministers, and the Ministry of Health," she said.

The head said the current situation in the market for laboratory quality control services for medicines could lead to the disappearance of a number of drugs from the market.

"We have much less medicine on the market than there was a few years ago, or even two years ago. Of course, this is due to the war, complex logistics, but also the prohibitions that our State Medical Service applies. If the performers could not understand how conduct a study, they simply write that the medicine does not meet the declared quality and the State Service on Medicines is introducing a ban throughout the country,” she said.

According to her, a subjective approach to organizing quality control of medicines and the involvement of insufficiently qualified specialists in monitoring can lead to the fact that the drug will actually be removed from our market.