To make a list: pharma cannot establish the production of innovative drugs

Pharmaceutical manufacturers have complained to the government about the lack of criteria for inclusion in the list of strategically important medicines. They are necessary for planning investments in the organization of full—cycle production - starting from January 1, 2026, preferences for such companies should be earned. As a result, this undermines the achievement of the goal of ensuring technological sovereignty and drug independence, the authors of the appeal claim. However, this preference is unlikely to take effect from the beginning of next year — the Ministry of Finance has developed a draft resolution in which the deadlines are shifted by six months. In the future, experts interviewed by Izvestia believe that the postponement may lead to the fact that pharma will lose interest in expanding production, and a number of investment projects will remain unrealized.

When will the preferences work?

The criteria for forming a list of strategically important medicines have not yet been approved in Russia, although they were supposed to appear by September 2025, the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union drew the government's attention (the letter is available to Izvestia).

"From January 1, 2026, additional preferences for manufacturers of pharmaceutical substances are scheduled to enter into force: the deepening of the "second superfluous" rule (the domestic product will win the tender if the second is imported. — Ed.) for medicines and the provision of additional price advantages for medicines," the association said in its appeal, which was confirmed to Izvestia by a source close to the government.

The lack of criteria does not allow us to approve the list of NWFPS — accordingly, preferences for the industry are in question, said Alexey Kedrin, Chairman of the association's Board. While there is no understanding of which strategic drugs are needed, he explained, pharmaceutical companies cannot begin planning investments in the organization of full-cycle production.

— All this suspends the achievement of the goal of ensuring technological sovereignty and drug independence, — says Alexey Kedrin.

In his opinion, the approval of the SZLS list should stimulate the localization of full—cycle drug production in Russia, reduce the import dependence of the healthcare system and ensure uninterrupted access of patients to strategically important drugs regardless of external circumstances - pandemics or international sanctions.

— The price preference should be applied to drugs intended for the treatment of socially significant diseases, diseases that pose a threat to others, disabling diseases included in the national project "Long and active life", which have no analogues or for which full—cycle production is provided, - says the head of the association. — The same applies to antibiotics due to the impossibility of providing medical care without them in some cases.

According to the government decree of March 2024, the development of the procedure and criteria for the formation of a list of strategically important medicines was to be completed in May 2025, and the list itself was to be updated in September this year.

In response to a request from Izvestia, the press service of the Ministry of Health reported that a draft government decree approving the procedure and criteria for forming a list of strategically important medicines is currently undergoing regulatory procedures. After that, the document will be submitted to the government.

They added that during the regulatory procedures, a number of changes were made to the draft resolution. However, they did not specify which ones.

The press service of the Ministry of Finance reported that the Ministry of Health must prepare criteria for the formation of a list of strategically important medicines by June 10, 2026, and in this regard, the Ministry of Finance has prepared draft amendments to the government decree.

Izvestia also sent a request to the Ministry of Industry and Trade.

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They will provide medicines to hard-to-reach and small settlements.

When can the criteria appear?

As Izvestia found out, pharmaceutical manufacturers are unlikely to be able to apply for preferences from the beginning of 2026. On November 25, the Ministry of Finance posted for public discussion a draft government decree changing the effective date of the "second extra" rule for medicines from the list of strategically important ones. It is proposed to postpone it to July 1, 2026. The discussion will last until December 10 of the outgoing year.

According to the explanatory note to the document, the development of legal acts that are supposed to approve the procedure and criteria for forming a list of strategically important medicines is scheduled until March 24, 2026, and their list until June 10.

The Infarma Association supported the Finance Ministry's proposal to postpone the deadline, Vadim Kukava, the organization's executive director, told Izvestia. According to him, in order for the mechanism to truly turn into a tool to support domestic manufacturers, it is necessary that the list of drugs subject to the "second superfluous" rule be compiled on the basis of clear and transparent criteria. And that takes time.

— It is necessary that the list contains not only the active ingredients, but also dosages, form of release and methods of administration. It is also worth working out a mechanism for monitoring the traceability of pharmaceutical substances. It is important that unscrupulous companies cannot import substances under the guise of reagents and pass off imports as domestic production," Vadim Kukava believes.

In addition, according to the expert, it is important that the list be linked to patent rights: it is necessary to preserve the criterion providing for the absence of valid exclusive rights to pharmacologically active substances.

Alexander Bykov, Director of Healthcare Economics at R-Pharm, believes that postponing the introduction of the "second superfluous" is a window of opportunity for pharmaceutical manufacturers.

"They have time to test key mechanisms in practice, such as the traceability of raw materials and the assessment of the stages of substance synthesis, and make them as transparent and unambiguous as possible for all market participants," he stressed.

In addition, according to the expert, in this case it becomes possible to clarify approaches to the formation of an updated list of NWFPs.

However, other industry representatives interviewed by Izvestia supported the appeal to the government. A change in the effective date of preferences for manufacturers of drugs from the SZLS list may lead to a regression in the pharmaceutical market, says Alexander Semenov, President of Active Component.

— Over the past five years, during which the "second extra" has been discussed, the industry has been stagnating. This is clearly seen in the share of Russian positions in the public procurement market in monetary terms: in 2020 it was almost 44%, and by 2025 it had decreased to 39%," he recalled.

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His non-release may cause death, experts noted.

Delaying the introduction of measures to strengthen drug sovereignty, according to the expert, may be fraught with a loss of interest in expanding production, curtailing investment projects and the inability to develop and produce original innovative drugs.

— Until now, the pharmaceutical industry has been developing at the expense of private investors with minimal government support. Expecting preferences in public procurement, Russian pharmaceutical companies have invested more than 100 billion in the creation of full—cycle production facilities," emphasized Alexander Semenov. — Manufacturers are ready to take on additional obligations in order to ensure transparency and effectiveness of the "second extra" preference. But it turns out that they don't get any of the promised benefits.

The expectation of a "second extra" for drugs from the SZLS list has encouraged investors to invest in a full cycle and increase their portfolio of local drugs, said Dmitry Nakhamchen, Director of Government Relations and Market Access at Geropharm. But now this process is being delayed and may lead to a decline in interest from industry representatives, said a representative of the pharmaceutical industry.

Any decision must be calculated, added Nikolay Prokhorenko, an expert in the field of public health. According to him, the criteria may still not be approved precisely because of financial inconsistencies.

— There is no guarantee that there are opportunities behind the expansion of preferences. For an objective assessment of the benefits, it is necessary to conduct a thorough analysis when they begin to act," he said.

As a result, the industry may be negatively affected not by the lack of criteria, Nikolai Prokhorenko summarized, but by the lack of proper financing.