Law Messenger

Price rises for drugs not on the essential medicines list: anti-monopoly risks

25.08.2025

There has been an increase in the number of inspections and disputes between the Russian Federal Anti-Monopoly Service and pharmaceutical companies over price rises for drugs not on the essential medicines list (EML) and the justification for those rises.

HOW SERIOUS IS IT?

According to figures published by the Federal Anti-Monopoly Service (the FAS), in the first half of 2025 the agency requested pricing information in relation to 18 non-EML drugs from 21 Russian and foreign pharmaceutical companies[1].

There has been an increase in the number of legal disputes with the FAS over unjustified rises in drug prices, with the regulator accusing pharma companies of abusing their market dominance. This puts companies at risk of punitive sanctions:

Under part 1 of Article 14.31 of the Administrative Offenses Code of Russia (the AOC), companies can be fined from 300,000 to 1 million rubles for the commission of acts constituting abuse of a dominant position (the FAS has imposed such fines on pharma companies on several occasions)
Companies also potentially face a turnover fine under part 2 of Article 14.31 of the AOC (up to 15% of revenue from sales of the relevant product)

In addition, the FAS may (and does in practice) order a pharma company to set an economically justified price, i.e., the company is obliged to adjust the price in coordination with the FAS.

WHAT DO I NEED TO KNOW?

There are no detailed regulatory requirements or restrictions applicable to the pricing of non-EML drugs. It is important, therefore, to pay close attention to approaches taken by the FAS to proving a company’s market dominance:

Determination of the boundaries of a product market – the company’s market consists solely of its drug
In practice, the FAS defines a product market not by reference to an INN, but separately for each dosage strength, and in some cases even separately for the number of tablets in a pack
Definition of a dominant position – the company is dominant because the dosage strength cannot be changed
On examining the market, the FAS notes that the substitution of medicines with the same INN but a different dosage strength would be inadmissible for the patient
Proving the occurrence of monopoly pricing – a price is unreasonably high if it grows at a faster rate than costs
Where the make-up of sellers and buyers of a product and the conditions under which the product is circulated in the relevant market remain unchanged, while the change in costs needed to manufacture and sell the product is not consistent with the change in the price at which it is sold, the price increase may be deemed unjustified

Thus, there is a risk of a pharma company being declared a monopolist in the market for its product if the product has few or no equivalents with the same INN and the same dosage strength.

HOW DO I ASSESS MY COMPANY’S RISK?

Your product is the only one in Russia’s State Register of Medicines (SRM) with the relevant INN and dosage strength (red risk level)
Besides your product, there are another 1-2 drugs made by other manufacturers with the same INN and dosage strength in the SRM, or there are even more such drugs, but you believe that you have a greater share of your product market (yellow risk level)
Besides your product, the SRM includes drugs made by a number of other manufacturers with the same INN and dosage strength, and there are 4-5 or more available options for the drug in question (green risk level)

If you fall within the “green” risk level, we recommend monitoring the situation, staying informed about the number of competitors in the market and periodically reviewing the latest approaches taken by the FAS.

If you think that you fit the “yellow” or “red” risk criteria, we advise you to be proactive and start developing strategies to manage those risks right away.

The current approaches of the FAS should also be taken into consideration by companies that are reviewing their financial models and planning to alter drug prices (including where those changes are dictated by the restructuring of relationships with suppliers), since pricing issues can arise in relation to any drugs.

HOW CAN B1 HELP?

Developing a defense file showing why the price increase is technically justified, and working out a strategy for dealing with the FAS
Advising on evaluating a pharma company’s product portfolio (non-EML drugs), product markets and the risk of being deemed to have a dominant position in light of the FAS’s updated approaches, and reviewing state procurements under Laws No. 44-FZ and No. 223-FZ
Analyzing a pharma company’s current pricing procedures for non-EML drugs
Developing or reviewing pricing policies for non-EML drugs setting out economic and technological justifications for price changes/increases, and updating policies on the granting of discounts and bonuses