Resolution No. 769 of the Government of the Russian Federation, dated May 21, 2021, approved the Rules for Ensuring the Provision of Medical Care (Where Necessary, Outside the Russian Federation) to a Specific Child with a Severe Life-Threatening or Chronic Disease, Including a Rare (Orphan) Disease, or to Groups of Such Children (hereinafter the “Rules”).

The Rules apply to citizens of the Russian Federation under the age of 18.

To organize the financial support for providing medical care to children with severe conditions, the Circle of Kindness Foundation (hereinafter the “Foundation”) must approve a list of severe life-threatening and chronic diseases, including rare (orphan) diseases, alongside a list of child categories suffering from such conditions. The Foundation establishes the list of diseases based on the following criteria:

• the prevalence of the disease does not exceed 10 cases per 100,000 population, and/or the disease is a severe chronic condition that, absent pathogenetic treatment, leads to significant impairment of vital functions or childhood mortality;
• treating the disease requires supplemental financial support for medical care provided to children with orphan diseases—including the provision of medicines, medical devices, and technical means of rehabilitation—in addition to the standard volumes of medical care provided to citizens under the Compulsory Health Insurance (CHI) program;
• targeted pathogenetic medicines, medical devices designed to treat or correct life-threatening diseases, or technical means of rehabilitation are available for the treatment of the disease and are registered in the Russian Federation, the European Union, and/or the United States of America;
• a treatment method with scientifically proven efficacy exists for the condition.

The Foundation shall review the specified list at least once every two years.

The Foundation compiles the list of child categories based on criteria such as:

• the presence of clinical characteristics in the progression of the disease where an adverse outcome may occur without the administration of medicines, medical devices, and technical means of rehabilitation;
• the absence of specific disease characteristics or clinical conditions that render the use of medicines, medical devices, and technical means of rehabilitation intended for treating diseases on the list technically or otherwise impossible.

The Foundation compiles these lists based on proposals submitted to it by Chief Independent Specialists of the Ministry of Health, regional executive healthcare authorities of the constituent entities of the Russian Federation, public associations for the protection of patient rights, charitable organizations, and the legal representatives of children.

The program provides medical care to a specific child with an orphan disease when the clinical case requires new, complex, and/or unique treatment methodologies, as well as resource-intensive methods with scientifically proven efficacy. This includes cellular technologies, robotics, information systems, and genetic engineering techniques developed from advancements in medical science and related technical fields that fall outside the standard list of high-tech medical care types covered by the program of state guarantees of free medical care to citizens.

Grants allocated to the Foundation from the federal budget in the form of subsidies, alongside other sources provided for by law, finance the supplemental financial support for activities related to providing medical care to a specific child with an orphan disease.

The Expert Council of the Foundation authorizes the provision of medical care to a specific child with an orphan disease based on a copy of an inpatient discharge summary issued by the federal medical organization to which the child was referred. This summary must detail the patient's health status and explicitly recommend the necessity of a complex type of medical care for treating the child's orphan disease.

Notably, the document permits decisions to provide care to children outside of Russia if the necessary clinical interventions cannot be delivered within the country.

Subsidies granted to the Foundation from the federal budget, along with other legally prescribed sources, finance activities related to providing medical care outside of Russia to a specific child with an orphan disease. These funds are specifically allocated for:

• paying foreign organizations in foreign currency for clinical services related to treating a specific child with an orphan disease;
• making payments in Russian Rubles to Russian citizens sent for treatment abroad and their accompanying persons (legal representatives and/or medical professionals where medically indicated):
• per diem allowances in the amount established for employees of federal state bodies, state extra-budgetary funds of the Russian Federation, and federal state institutions during official business travel to foreign countries;
• allowances for lodging expenses in the amount established by regulatory legal acts governing the reimbursement of foreign business travel expenses for employees of federal state bodies, state extra-budgetary funds, and federal state institutions;
• allowances for travel expenses to and from the treatment destination, capped at the actual travel costs for the child and the accompanying person: by air (economy class), rail (compartment carriage of a fast train), water (Group V cabin of a regular merchant vessel or integrated passenger service line, Category II cabin of a river vessel across all routes, Category I cabin of a ferry crossing), or road (public transport vehicles, excluding taxis).