Foundation for support of children with severe life-threatening and chronic diseases, including rare (orphan) diseases (“Circle of Good” or “Fund”) was established by the decree1 of the President of the Russian Federation in 2021. The main goal of the Fund’s activities is to implement an additional mechanism for organizing and financially providing medical care to children with severe life-threatening and chronic (including rare (orphan)) diseases and providing such children with drugs and medical devices (including those not registered in Russia), as well as 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. The Fund is financed mainly by deductions from the increased personal income tax rate, which is valid for income over 5 million rubles a year. These funds are transferred to the federal budget and then granted to the Fund in the form of subsidies.
In pursuance of the Presidential decree and to ensure the functioning of Circle of Good, the Russian Government has approved several normative acts:
1. Rules for ensuring the provision of medical care (if necessary outside Russia) to a particular child with a serious life-threatening or chronic disease, including a rare (orphan) disease, or groups of such children2
The rules apply to children under 18 y.o. who are Russian citizens. Medical care for such children can be provided both in the territory of Russia and abroad based on proposals and applications sent to the Fund from a certain circle of persons specified by the rules. The procedure for sending proposals and applications is regulated by the rules.
Besides, the rules establish the criteria that must be considered by the expert council of the Fund when forming the following lists:
- List of diseases – a list of severe life-threatening and chronic diseases, including rare (orphan) diseases
- List of categories of children – a list of categories of children with the stated diseases, for which the appointment of drugs, medical devices, and technical means of rehabilitation is approved
- List for procurement – a list of drugs purchased by the Ministry of Healthcare of the Russian Federation or a state institution subordinate to it for the needs of the Fund, and a list of drugs, medical devices, technical means of rehabilitation purchased by the Fund for providing medical care to children
The rules also establish the procedure for forming and changing these lists.
2. Rules for the purchase of drugs and medical devices for a particular child with a serious life-threatening and chronic disease, including a rare (orphan) disease, or groups of such children3
The rules regulate the procedure for purchasing products for the needs of the Fund in more detail. The procedure depends on the list to which the products belong:
- Purchases by the Ministry of Healthcare of the Russian Federation or a state institution subordinate to it for the needs of the Fund (list No. 1)
- Independent purchases by the Fund (list No. 2)
List No. 1 includes only drugs, whereas list No. 2 includes drugs, medical devices, and technical means of rehabilitation.
The lists are published on the website of Circle of Good4 and are periodically updated as decisions are made by the Fund’s authorized bodies.
3. Rules for maintaining an information resource containing data on children with severe life-threatening and chronic diseases, including rare (orphan) diseases, including data on the purchase of medicines and medical devices for such children, including those not registered in Russia, technical means of rehabilitation, and information about the results of treatment of such children5
The rules establish the procedure for maintaining an information resource. The information resource is maintained by the Fund in electronic form as part of the unified state information system in the field of healthcare and contains federal and regional segments.
1Decree of the President of the Russian Federation No. 16 of 05.01.2021
2Approved by the Decree of the Government of the Russian Federation No. 769 of 21.05.2021
3Approved by the Decree of the Government of the Russian Federation No. 545 of 06.04.2021
4https://xn--80abfdb8athfre5ah.xn--p1ai/lists#rec287114063
5Approved by the Decree of the Government of the Russian Federation No. 555 of 08.04.2021