As Valery Afanasyev, Partner, GR & Risk at Baikal Lobridge, notes, the regulation sets out two mandatory criteria. First, a region’s estimated fiscal capacity must not exceed 0.65, meaning it must be a subsidized region. According to 2024 data, 31 Russian regions met this criterion. Second, the region must allocate at least 10% more funding for the procurement of these medicines than it did the previous year. In addition, the region must meet at least one of several other criteria, such as a 20% or greater increase in drug prices or a 15% or greater increase in the number of patients.
The Russian Government has approved the rules and criteria for additional federal subsidies to help regions purchase expensive orphan drugs. Government Resolution No. 1807, dated November 15, 2025, was signed by Prime Minister Mikhail Mishustin and will come into force on January 1, 2026.
The regulation provides a mechanism for regional authorities to formally confirm that they are objectively unable to fulfill their responsibilities for providing medicines to patients with diseases listed in Government Resolution No. 403 of April 26, 2012.
Regional governors will be able to submit subsidy applications each year from August 1 to September 30. The Ministry of Health will review applications within 10 business days. If an application is rejected, for example, because the region does not meet the criteria or the required documents are incomplete, the region will be able to submit a new application.
According to Valery Afanasyev, the adoption of Federal Law No. 252-FZ of July 23, 2025, left several issues unresolved, including the application procedure and the criteria for receiving subsidies. The new resolution clarifies that a region must meet at least three criteria to apply, two of which are mandatory.
Read more in the article published by Pharmaceutical Bulletin.
The Russian Government has approved the rules and criteria for additional federal subsidies to help regions purchase expensive orphan drugs. Government Resolution No. 1807, dated November 15, 2025, was signed by Prime Minister Mikhail Mishustin and will come into force on January 1, 2026.
The regulation provides a mechanism for regional authorities to formally confirm that they are objectively unable to fulfill their responsibilities for providing medicines to patients with diseases listed in Government Resolution No. 403 of April 26, 2012.
Regional governors will be able to submit subsidy applications each year from August 1 to September 30. The Ministry of Health will review applications within 10 business days. If an application is rejected, for example, because the region does not meet the criteria or the required documents are incomplete, the region will be able to submit a new application.
According to Valery Afanasyev, the adoption of Federal Law No. 252-FZ of July 23, 2025, left several issues unresolved, including the application procedure and the criteria for receiving subsidies. The new resolution clarifies that a region must meet at least three criteria to apply, two of which are mandatory.
Read more in the article published by Pharmaceutical Bulletin.
