According to Valery Afanasyev, Director for Government Relations and Regulatory Risk Assessment at Baikal Communications Group, the Resolution establishes two mandatory criteria. First, the level of calculated budgetary sufficiency must not exceed 0.65 — meaning the region must be classified as subsidized. As of 2024, there were thirty-one such regions in Russia. Second, the constituent entity of the Russian Federation must allocate at least ten percent more funds for financing the procurement of these medicinal products compared to the previous year. Among the optional additional criteria are either an increase in the cost of the medicinal products by no less than twenty percent or an increase in the number of patients in the region by no less than fifteen percent.

The Government of the Russian Federation has approved the rules and eligibility criteria for receiving additional federal co-financing for the procurement of high-cost orphan medicinal products. Resolution No. 1807 of 15 November 2025, signed by Prime Minister Mikhail Mishustin, will enter into force on 1 January 2026.

The regulatory act establishes a mechanism through which regional authorities may formally confirm that they are objectively unable to fulfill their obligations to provide medicinal support to patients with the diseases listed in Government Resolution No. 403 of 26 April 2012.

Applications for subsidies may be submitted annually by the heads of regional authorities from 1 August to 30 September. The Ministry of Health of the Russian Federation will review the applications within ten business days. In the event of a refusal — for example, due to non-compliance with the criteria or an incomplete set of documents — the region may resubmit the application.

According to Valery Afanasyev, after the adoption of Federal Law No. 252-FZ of 23 July 2025, a number of issues remained unresolved, particularly those related to the application procedure and the eligibility criteria for subsidies. The adopted Resolution clarifies that, to submit an application, a region must meet at least three criteria, two of which are mandatory.

More details are available in the Pharmvestnik report.

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