Life commitments: Russians may lose access to modern therapy
Prices for some vital medicines in Russia may rise due to the loss of competition. Market participants are warning about this ahead of the entry into force of the "second extra" rule. Its essence is that in public procurement, preference is given only to domestic medicines. As a result, patients may lose access to the original drugs from the list of VED and strategically important medicines, industry experts add. In particular, we are talking about psychotropic and narcotic drugs, blood products — in total, the restriction may affect 215 items, among which there are drugs for oncological diseases. For more information about patients' concerns and how justified they are, see the Izvestia article.
What are the risks of introducing the "second extra" rule?
The "second extra" rule, which will officially begin operating in Russia from September 2025, may lead to a decrease in the availability of medicines and an increase in the cost of purchasing them. According to the law, if drugs that are fully manufactured in Russia participate in the competition, the remaining applications will be rejected as foreign. Concerns have already been expressed in the All-Russian Union of Patients (VSP), noting that this will affect drugs from the list of strategically important ones, which partially includes drugs from the list of vital and essential.
Since January 1, 2025, the "second extra" mechanism has been applied to foreign drugs whose production is not localized in Russia. Such goods are rejected at auction, regardless of their price, if at least one request from Russian manufacturers is received during the purchase. From September 1, 2025, benefits will be given only to full-cycle Russian manufacturers.
The VSP has sent a letter to the Government asking it to review the categories of drugs that will fall under this mechanism. The Cabinet of Ministers told Izvestia that they had forwarded the letter from the patients' union to the Ministry of Industry and Trade and the Ministry of Health.
"The list of such drugs is planned to include narcotic and psychotropic drugs, blood products, as well as 215 items from the current list of strategically important drugs," the document says. "The proposed restriction will significantly reduce the annual savings on auctions and, taking into account the annual increase in demand for medicines, will inevitably lead to an increase in healthcare costs and an artificial monopolization of drug production."
The list of vital and essential drugs includes 894 international nonproprietary names (INN) or 6.8 thousand trade names, according to the report of the IT company in the segment of collection and analysis of tender purchases of medicines "Cursor". Of these, 70% belong to local production, while 40% are produced at the facilities of domestic companies from imported substances, and 30% from Russian ones.
The VSP believes that the mechanism should be used only for the most minimal list of drugs, and the rest — from the list of strategically important ones — should be provided with percentage advantages at auction (preferences) and other support measures.
The implementation of the rule may lead to supply disruptions, limited product range and reduced availability of modern therapy for patients, said Yan Vlasov, Co-chairman of the VSP.
— There are categories of patients, for example, with oncological diseases, who, if their drugs nevertheless fall under the action of the mechanism, may find themselves in a critical situation. Any delay in providing the drug or its abrupt replacement negatively affects their condition," he added.
Striving to achieve drug sovereignty is the key to making effective therapy accessible to Russians, but "in the struggle for independence, one cannot shut oneself away from foreign innovations," said Yuri Zhulev, co—chairman of the VSP.
"There is practically no complete independence in the production of drugs in any country in the world — one way or another, biotechnologies and some drugs are imported in different volumes," he stressed.
The press service of the Ministry of Health, in response to a request from Izvestia, reported that the draft government decree "On approval of the procedure and criteria for forming a list of strategically important medicines" is currently undergoing interdepartmental coordination.
"Therefore, we consider it premature to talk about any changes in procurement procedures as a fait accompli, as well as their entry into force on a specific date," the ministry stressed.
The Ministry of Industry and Trade did not respond to the editorial request.
What is the pharmaceutical industry's position
Currently, the application of the "second extra" rule is being discussed exclusively in the context of drugs included in the first section of the list of strategically important medicines, Vadim Kukava, executive director of the Infarma Association, told Izvestia.
According to him, the application of the rule in relation to narcotic and psychotropic drugs, as well as drugs for immunoprophylaxis and blood plasma does not cause concerns on the part of the industry. However, Infarma and a number of other associations have repeatedly proposed limiting the first section of the list of strategically important medicines to drugs with at least two independent manufacturers.
— Such an approach, firstly, would guarantee uninterrupted supplies in case the manufacturer for some reason cannot ensure their production in the required quantity, and, secondly, would ensure healthy competition between manufacturers, — said Vadim Kukava.
Also, according to him, the majority of domestic and foreign manufacturers who have localized production in Russia are extremely concerned about the possibility of expanding the list of drugs from the first section of the list, as in this case difficult-to-predict risks are possible.
— It is not yet clear whether the rule will be limited only to narcotic and psychotropic drugs and drugs for immunoprophylaxis and blood plasma. There is a possibility that it may be extended to other drugs from the list of CFS, which includes, for example, medicines for HIV infection and diabetes," he stressed.
The association members share the concerns of the patient community, Vadim Kukava noted.
— The "second extra" rule is an experiment. It is necessary to take into account the fact that this mechanism is being used for the first time, as well as the fact that it is being introduced specifically for drugs. That is, the most sensitive social sphere, which only increases the possible risks," he said. — The introduction of the mechanism can potentially lead, for example, to a defect (absence of a certain product. — Ed.).
There should be a price preference for the vast majority of manufacturers, said Alexey Torgov, Deputy General Director for Corporate Relations and Communications at the biotech company Biocad. According to him, the 30 percent preference offered by the Ministry of Industry and Trade and the Ministry of Finance for full-cycle drugs will be sufficient to stimulate drug localization and fairer for manufacturers.
"This approach will help to mitigate the risks for patients," he believes.
Alexander Bykov, Director of Healthcare Economics at R-Pharm, recalled that an additional two-year period was provided for the non-application of preferences to drugs newly included in the list of medicines, which would reduce the risks of market monopolization and the occurrence of defects.
Thus, according to him, the provision of patients will remain in full, while domestic companies will receive an incentive to deepen the localization of drug production, which will contribute to strengthening the country's drug safety.
What concerns arise
Despite the concerns after the introduction of the "second extra" rule, the experts interviewed by Izvestia do not see any serious risks. For example, Nikolay Bespalov, Director of development at RNC Pharma, an analytical company, is confident that there should not be a significant increase in costs after the introduction of the mechanism in the healthcare system.
Larisa Popovich, director of the HSE Institute of Health Economics, also believes that the "second extra" rule will not lead to an increase in healthcare system costs.
— Drug prices will decrease with the introduction of the rule, since regulatory standards have been established for medicines from the VED and NWLS: they cannot be higher than the registered cost. Consequently, the healthcare system will benefit, the expert believes.
The expert of the direction "Popular Front. Analyst Valery Alekseev noted that de facto, in some drug positions, the conditional "second extra" is already working in public procurement.
"If you look at federal and regional auctions for medicines, there is no competition in many procedures," he explained.
According to him, the issue of the list of strategically important medicines and VED is not a question of price and health care costs, but of the balance of drug safety and support for domestic manufacturers who launch drugs based on Russian substances.
On the one hand, it is important to have confidence in the country's ability to fully meet its basic needs, and on the other hand, there must be an alternative action plan in which the medical supply to the population will not stop due to production disruptions, the expert emphasized.
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