Biocad filed a complaint with the FAS against Deputy Head of the Ministry of Health Sergei Glagolev

Biocad, which is unable to include its drugs for the treatment of multiple sclerosis in the lists of vital and high-cost nosologies, and therefore gain access to state tenders, complained to the Federal Antimonopoly Service about the inaction of the Deputy Head of the Ministry of Health Sergei Glagolev. The official heads the commission that forms the lists, but its meetings have not been held for almost a year. The agency can issue a warning to the official, but lawyers call this a “soft coercion tool” that is unlikely to quickly help the company.

Kommersant obtained a copy of the complaint filed by Biocad on January 22 to the Federal Antimonopoly Service (FAS) about the inaction of the Deputy Head of the Ministry of Health of the Russian Federation, Sergei Glagolev. The official heads the ministry’s commission for the formation of, among other things, lists of vitally important drugs (VED) and drugs for the program “14 high-cost nosologies” (14 VZN). The FAS and the Ministry of Health did not respond to Kommersant’s request.

The last time the commission met was in February 2023, although it is usually held quarterly. The last time the list of vital and essential drugs was updated was in June 2023, but only due to new forms of drugs already available there. As a result, 32 applications from various pharmaceutical manufacturers to include their drugs in the lists remain unconsidered.

For this reason, for example, Biocad cannot include in the lists two drugs for the treatment of multiple sclerosis – Ivlizi based on divosilimab and sampeginterferon beta-1a, registered by the company in the spring of 2023. On this issue, Biocad has already sent an open letter to the head of the Ministry of Health, Mikhail Murashko, and five industry associations in August 2023 asked Prime Minister Mikhail Mishustin to speed up the meeting of the commission (see Kommersant on December 25).

Now Biocad is asking the FAS to conduct an unscheduled inspection and, if there are grounds, issue an order to eliminate violations and bring Sergei Glagolev to administrative responsibility. The inaction of the commission, headed by an official, according to the pharmaceutical manufacturer, “creates a competitive advantage for other drugs.”

In turn, drugs not included in these lists are purchased through state tenders to a limited extent. According to the government procurement website, in 2023, divosilimab was purchased for 26.9 million rubles, sampeginterferon beta-1a – for 4 million rubles. At the same time, in January 2024, the Ministry of Health purchased 13.2 billion rubles from Roche. two years ahead, ocrelizumab is a drug in the same group as divosilimab. “Biocad” writes in a complaint to the FAS that it is deprived of the opportunity “to wage an equal economic struggle with foreign manufacturers” and to receive a rate of return that allows it to recoup investments.

The FAS can issue a warning to an official, but this is a “soft coercion tool” and does not imply the initiation of an antimonopoly case, says Alexander Muravin, head of commercial practice at ALUMNI Partners. But, according to him, several meetings have already not taken place, and the subject of warning can only be another postponement of the commission meeting in the future. The expert also reminds that FAS representatives are included in the commission and the reasons must be known to the service and considered objective.

It will be difficult to cancel the auction for the government purchase of the drug from Roche Biocad, Mr. Muravin believes. To do this, according to him, it is necessary to prove a cause-and-effect relationship between the violation and the results of the auction, and the contract itself will already be executed by that time.

Even if Biocad achieves a meeting of the commission, the application period for generating the requirements for drugs under the 14 VZN program for 2024 has already ended, notes Aleksey Fedorov, an expert at the All-Russian Patients’ Union. He also recalls that approval of the drug by the commission may not lead to its eventual inclusion in the lists. This happened in 2022, when the government approved only five of the 19 drugs approved by the commission into the VED, and none of the three candidates for inclusion in the VND.

Polina Gritsenko