Pharmaceutical companies cannot bring their drugs to market

After industry associations of the pharmaceutical industry failed to get the government to include new drugs in the list of essential drugs, players began to solve the problem on their own. Thus, Biocad, which is trying to get its drug for the treatment of multiple sclerosis included in the list, is seeking support from the Federal Antimonopoly Service. The process is being delayed for all companies, as the Ministry of Health is waiting for the adoption of new, more stringent rules for including funds in the lists, experts believe. Manufacturers are afraid of the prospect of losing the opportunity to participate in government procurement.

Kommersant obtained a letter from Biocad to the Federal Antimonopoly Service (FAS). The company asks the department to assist in including the original drug “Ivlizi”, developed by it, based on divosilimab, into the list of vital drugs (VED) for patients with multiple sclerosis. The drug, the company writes, has not yet been included in the program for 14 high-cost nosologies (14 VZN). Because of this, Biocad cannot participate in government procurement with its drug.

The structure of the Ministry of Health plans to purchase at the next auction for 13.2 billion rubles. immediately for 2024–2025, ocrelizumab, a drug for multiple sclerosis with a similar indication. “Biocad” insists that Roche’s medicine will be purchased at the planned tenders and “at least until 2026, the majority of patients will be provided with it and doctors will not be able to massively use the Russian medicine during this period.”

The company adds that the full cycle production of its drug within the country is supported by the Ministry of Industry and Trade, while ocrelizumab is only packaged in Russia. Roche insists that it has localized the production of its drug in 2019 at the facilities of R-Pharma.

The FAS confirmed to Kommersant that it had received the appeal, indicating that it would be considered in the prescribed manner. The Ministry of Health did not respond to Kommersant’s request.

The main problem why Biocad cannot get its drug included in the list is that this year the meeting of the commission under the Ministry of Health that forms such a list is constantly postponed. On this occasion, the company has already contacted Deputy Prime Minister Tatyana Golikova, who instructed the Ministry of Health to consider the need to hold a meeting of the commission. The ministry, in its response to the Deputy Prime Minister (Kommersant has a copy of it), promised to consider the issue of including the drug Biokada on the list at the next meeting of the commission.

A number of specialized associations applied to the government back in the summer with a request to instruct the Ministry of Health to speed up the process of including new drugs in the list of vital and essential drugs, pointing out that the lack of clarity does not allow companies to plan production and supply volumes (see Kommersant on August 11). According to Kommersant’s calculations based on data from the Ministry of Health, applications from 32 pharmaceutical companies remain unconsidered by the commission.

For example, the application of the British-Swedish AstraZeneca for ravulizumab, used in the treatment of atypical hemolytic uremic syndrome, also included in the 14 WNV program, has not yet been reviewed. Although bidding for 2024 for the purchase of 4.4 billion rubles. Another treatment for this disease, eculizumab, has also already been announced. “Further delay in the commission’s work raises the question of the commercial feasibility of bringing innovative drugs to the market,” AstraZeneca told Kommersant.

Commission meetings are constantly postponed due to the fact that the Ministry of Health is waiting for the adoption of amendments to the rules for creating lists, co-chairman of the All-Russian Society of Patients Yuri Zhulev does not rule out. According to him, the draft updated rules, tightening the procedure for including drugs in the lists of vitally important and 14 VZNs, were published for public discussion back in June 2023, but have not yet been approved by the government.

Previously, there was no practice of postponing meetings, explains Alexey Fedorov, an independent expert on government procurement in the pharmaceutical industry. He believes that submitted applications should be considered as early as 2024. According to current legislation, the government is obliged to update the list of vital and essential drugs at least once a year.

Polina Gritsenko