Rising inflation, risks of drug shortages, and prices for medicines on the Vital and Essential Drugs list are pressing issues for both Russian and international manufacturers. In the event of dumping, registration refusal, or other force majeure circumstances, it is the Russian pharmaceutical market and the end consumer that suffer first. Priorities for drug provision and the specifics of price regulation were discussed at the recently held forum “Pharmaliga – A Meeting of Leaders” in Moscow.
The strategic session with pharmaceutical market regulators at the recent Pharmaliga forum was opened by Timofey Nizhegorodtsev, Deputy Head of the Federal Antimonopoly Service of Russia.
He stated that the complex process of price regulation is practically complete and is currently undergoing fine-tuning.
“There were assumptions that under Resolution No. 1771, which approves the specifics of state regulation of maximum manufacturer selling prices for drugs included in the list of vital and essential drugs, the number of applications would sharply increase in the event of shortages or the risk of their occurrence, but this did not happen,” he added.
On the contrary, 2025 has revealed an opposite trend – a decrease in the number of applicants and, as a result, an increase in the number of registration rejections.
“When there is a risk of shortages, we first agree on new prices, and if prices in the markets of reference countries remain at similarly high levels, we confirm them. But if the situation in the reference country markets has not changed, unlike the forecasted values when we increased the price, and prices remain at the same low levels, we return the prices we raised to their previous level,” Nizhegorodtsev emphasized.
Important changes have affected companies producing generics: they are now permitted not to reduce prices below the threshold levels recorded in reference countries.
Plans are underway to adjust the procedure for registering and revising maximum selling prices for blood products. The FAS expects to establish a stable regulation that will take into account the specificities of blood product manufacturing and reduce the number of repeated price reviews when they are economically justified.
Timofey Nizhegorodtsev also reported that companies are not exceeding wholesale and retail markups. However, according to him, there are also manufacturers who attempt to circumvent price regulation for both drugs included in and excluded from the Vital and Essential Drugs list.
During his speech, Russian Deputy Minister of Health Sergey Glagolev noted that the Ministry of Health continues to focus on price regulation, distance trading, improving pricing mechanisms, and administrative issues concerning state players.
“Just before the coronavirus pandemic, a system for distance trading of over-the-counter drugs began operating, and the retail segment responded quite well to this effort. An experiment on online trade of prescription drugs is currently underway. Although the results there are significantly lower, working through this mechanism will still provide valuable experience,” he said.
The Deputy Minister also noted the need for fine-tuning the labeling system (MDLP). According to him, to make the system more efficient and transparent, it is necessary to improve the accounting of medicines based on actual sales data. Furthermore, he emphasized the importance of maintaining the accessibility of medicines, including those subject to strict records, and strengthening control over their availability.
