The possible refusal of pharmaceutical companies to release several essential drugs (VED) due to the low ceiling price pushed officials to speed up the problem’s solution. For example, the Federal Antimonopoly Service (FAS) and the Ministry of Health propose raising prices for medicines that are in short supply due to the unprofitability of their production. Experts and market participants believe that VED pricing should be more efficient and flexible. For the calculation, it is worth taking the cost of raw materials, which have risen in price by 30–40% over the past two or three years.
The fact that the Ministry of Health is developing a mechanism for increasing the maximum selling prices for vital and essential drugs, which are in short supply due to the unprofitability of production, said the source of Kommersant on the pharmaceutical market. Deputy head of the FAS Timofey Nizhegorodtsev confirmed to Kommersant that the department had developed such a document together with the Ministry of Health. According to him, the project is being finalized and coordinated between the federal executive authorities. The Ministry of Health did not answer Kommersant’s questions.
Earlier, several pharmaceutical companies, including Viktor Kharitonin’s Pharmstandard, warned the Ministry of Industry and Trade about the refusal to release some drugs in the VED list due to the low maximum allowable price ( see Kommersant dated April 21 ). For example, the maximum price for a paracetamol package of 20 tablets in a dosage of 0.5 g of “Biosynthesis” is 10.1 rubles. At the cost of 16.46 rubles. The company can sell a package of ibuprofen of 20 tablets with a dosage of 200 mg at a price of up to 12.05 rubles, and production costs 17.21 rubles.
As indicated by market participants, the situation was aggravated by the devaluation of the ruble and the COVID-19 pandemic, which led to an increase in demand and an increase in the price of imported substances.
In 2019, a new VED pricing methodology was adopted, according to which manufacturers must re-register prices by the end of this year. Thus, the cost of innovative drugs should not exceed their prices in several other countries, and the cost of analogs will be registered with a decreasing coefficient. New prices cannot exceed existing ones.
Timofey Nizhegorodtsev did not give details of the mechanism developed with the Ministry of Health. He clarified that the FAS advocated a revision of prices for generic drugs, the prices for which were registered in 2010, and proposed allowing companies to revise prices, taking into account unused indexation for drugs worth up to 100 rubles. An annual increase in prices for a double rate of inflation is allowed, but not all manufacturers use this opportunity, added Mr. Nizhegorodtsev.
The Ministry of Industry and Trade supports the revision of the ceiling prices for several drugs from the list of vital and essential drugs. It follows from the ministry’s letter to the Ministry of Health (a copy is available from “Kommersant”).
In particular, it is noted in the appeal, it is proposed to give the opportunity to re-register the maximum selling prices of manufacturers of the EAEU countries for drugs worth up to 100 rubles. to the level of the rise in prices for raw materials, but not more than 100 rubles.
The Ministry of Industry and Trade did not provide a comment.
DSM Group CEO Sergei Shulyak notes that indexing the cost of drugs after a shortage occurs is a belated decision. According to him, the price regulation mechanism should be made more flexible and efficient: “Today the manufacturer can ask for a revision of prices for VED once a year. But during this time, components for drugs can rise in price several times, which immediately affects the cost price and can make the production of drugs unprofitable. ”
Most pharmaceutical companies in the Russian Federation depend on imported raw materials. Any fluctuations in exchange rates immediately lead to a revision of these contracts, confirming Nikolay Bespalov, Development Director of RNC Pharma. In his opinion, VED’s marginal prices can be regulated preventively based on the cost of imported components, which is available in customs statistics. So, Mr. Bespalov notes, since 2017, imported raw materials for several drugs have risen in price by 30-40%, and price indexation for the inflation rate will not dramatically improve the profitability of production. However, the top manager calls it a plus that the regulator is, in principle, ready to offer business measures to index prices for vital and essential drugs.