Decree of the Government of Russia dated 06.04.2021 No. 545 approved the Procedure for the acquisition of medicinal products, medical devices and technical means of rehabilitation for a specific child with a serious life-threatening and chronic disease, including a rare (orphan) disease, or for groups of such children (hereinafter referred to as the “Procedure”).
The acquisition for children with severe life-threatening and chronic diseases, including rare (orphan) diseases, technical means of rehabilitation that are not included in the federal list of rehabilitation measures, technical means of rehabilitation and services provided to a disabled person is carried out by the Fund for Supporting Children with Severe Life-Threatening and Chronic Diseases, including rare (orphan) diseases, “Circle of Kindness” (hereinafter the “Fund”).
Recall that this Fund was created by the decree of the President of the Russian Federation dated 01/05/2021 No. 16. By the protocol of the Fund’s expert council No. 1 dated 02/03/2021, the lists of medicinal products necessary for the procurement of drugs for the provision of children were agreed. Currently, two lists of medicines have been approved. List No. 1 includes Nusinersen, Risdiplam, Mayozym, Canakinumab, Asphotase Alpha, Elosulfase Alpha. List 2 includes the only drug, Zolgensma.
The decision on purchases is made by the expert council of the Fund. When purchasing according to List 1, the Fund, within 3 working days from the date of receipt of the said decision of the Fund’s expert council, sends information on the need for medicinal products to the Ministry of Health of Russia with a list of recipients of medicinal products attached. The purchases are directly carried out by the Russian Ministry of Health. Suppliers of medicinal products, when fulfilling their obligations under the state contract, submit to the state customer documents confirming the fact of receipt of medicinal products with an indication of their nomenclature, quantity, and cost. Recipient organizations are obliged to accept them and ensure proper storage no later than 1 business day from the date of receipt of medicinal products.
Not later than 5 working days from the date of receipt of the documents-grounds for the deliveries made, a tripartite act on the transfer of medicinal products according to list No. 1 is drawn up.5
At the same time, according to List No. 2, the purchase of medicines is carried out by the Fund. The period for taking the medicinal product by recipient organizations is identical to the period established for List No. 1.
The redistribution of medicinal products between recipient organizations is carried out on the basis of the decision of the Fund, adopted in agreement with the Ministry of Health. The decision on redistribution is made taking into account the relevant decision of the Foundation's expert council in the absence of a need for certain medicinal products, medical devices, or an additional need for medicinal products, medical devices arise due to a change in the number of children with orphan diseases. The transfer of drugs, medical devices between recipient organizations is carried out on the basis of a decision on redistribution with the registration of an act of acceptance and transfer. Within 3 working days after the signing of the specified act, the recipient organization, which transferred drugs, medical devices, notifies the Fund and the Ministry of Health about the redistribution of drugs, medical devices.
Special attention in the Procedure is paid to medicinal products unregistered in Russia, which must be transferred to the legal representative of the child by a medical organization in which the child is under constant medical supervision on an outpatient basis, for a course of treatment in accordance with the prescription of the attending physician and taking into account the provision of a continuous course of treatment.
Also, Government Decree No. 555 of 08/04/2021 approved the Rules for maintaining an information resource containing information about children with severe life-threatening and chronic diseases, including rare (orphan) diseases, including information on the purchase of drugs and medical devices for such children, including a number of unregistered in Russia, technical means of rehabilitation, and information on the results of treatment of such children.
Through this information resource, the following are provided:
- processing and storage of applications of regional executive authorities filed in order to ensure the provision of medical care to a specific child with an orphan disease, provision of medicines, medical devices, technical means of rehabilitation, as well as applications of the legal representatives of children, on the basis of which these applications were formed;
- placement of the list of severe life-threatening and chronic diseases, including rare (orphan) diseases, and medicines purchased for such children, approved by the Foundation's expert council;
- formation, signing, and placement of minutes of meetings of the expert and board of trustees of the Fund;
- keeping records of information about children with orphan diseases and their parents (legal representatives);
- collection and analysis of information on the provision of children with medicines, medical devices, technical means of rehabilitation.
The information resource must be kept in electronic form as part of the Unified State Health Information System.
May 14, 2021
