Under Russian Government Decree No. 545 dated April 6, 2021, the Government approved the Procedure for the Acquisition of Medicinal Products, Medical Devices, and Assistive Technology Rehabilitation Equipment for Individual Children with Severe, Life-Threatening, and Chronic Diseases, Including Rare (Orphan) Diseases, or for Groups of Such Children (hereinafter the “Procedure”).

The Circle of Kindness Foundation for the Support of Children with Severe, Life-Threatening, and Chronic Diseases, Including Rare (Orphan) Diseases (hereinafter the “Foundation”), procures assistive technology rehabilitation equipment not included in the federal register of rehabilitation measures, technical rehabilitation equipment, and services provided to disabled individuals.

Presidential Decree No. 16 dated January 5, 2021, established the Foundation. Through Minutes No. 1 of the Foundation's Expert Council dated February 3, 2021, the council approved lists of medicinal products required for procurement to secure pharmaceutical supplies for children. Currently, two product lists stand approved. List No. 1 includes Nusinersen, Risdiplam, Myozyme, Canakinumab, Asfotase Alfa, and Elosulfase Alfa. List No. 2 contains a single medicinal product, Zolgensma.

The Foundation’s Expert Council renders procurement decisions. For procurements under List No. 1, the Foundation transmits pharmaceutical requirement data, alongside a list of designated recipient entities, to the Ministry of Healthcare of the Russian Federation within three business days of receiving the Expert Council's decision. The Ministry of Healthcare directly executes these procurements. When performing obligations under public contracts, pharmaceutical suppliers shall submit documentation to the public authority verifying the delivery of medicinal products, detailing their nomenclature, volume, and value. Recipient entities must accept the medicinal products and ensure proper storage conditions no later than one business day following delivery.

The parties shall execute a tripartite transfer act for List No. 1 medicinal products no later than five business days from receipt of the underlying supply documentation.

Conversely, the Foundation directly procures medicinal products under List No. 2. The timeline for recipient entities to accept these medicinal products remains identical to the period established for List No. 1.

The Foundation redistributes medicinal products among recipient entities subject to the approval of the Ministry of Healthcare. The Foundation issues a redistribution decision based on a corresponding determination by its Expert Council if a surplus occurs or if additional needs arise due to fluctuations in the number of children with orphan diseases. The transfer of medicinal products and medical devices between recipient entities proceeds under the redistribution decision and requires a formal acceptance and transfer act. Within three business days of signing the act, the transferring recipient entity shall notify both the Foundation and the Ministry of Healthcare regarding the redistribution of the medicinal products and medical devices.

The Procedure focuses closely on medicinal products unregistered in the Russian Federation. Medical organizations providing continuous outpatient medical supervision to a child must dispense these products to the child's legal representative for the prescribed course of treatment, ensuring uninterrupted therapeutic continuity.

Furthermore, Russian Government Decree No. 555 dated April 8, 2021, approved the Rules for Maintaining the Information Resource tracking data on children with severe, life-threatening, and chronic diseases, including rare (orphan) conditions. This tracking platform incorporates procurement data on medicinal products, medical devices (including those unregistered in Russia), and assistive technology rehabilitation equipment, alongside patient clinical outcomes.

This digital resource facilitates:

• The processing and storage of requests submitted by regional executive authorities to secure medical assistance, medicinal products, medical devices, and assistive technology rehabilitation equipment for individual children with orphan diseases, as well as the underlying applications submitted by their legal representatives;
• The publication of the registers of severe, life-threatening, and chronic diseases, including rare (orphan) conditions, approved by the Foundation's Expert Council, alongside lists of the specific medicinal products procured for these patients;
• The compilation, execution, and publication of minutes from the meetings of the Foundation's Expert Council and Board of Trustees;
• The tracking and management of data regarding children with orphan diseases and their parents or legal representatives; and
• The collection and analysis of data regarding the provision of medicinal products, medical devices, and assistive technology rehabilitation equipment to children.

The platform operates digitally as an integrated component of the Unified State Health Information System (EGISZ).