The Ministry of Health narrows the “Circle of Good” – Newspaper Kommersant No. 126 (7327) of 07/15/2022

The Presidential Fund for Helping Children with Serious Illnesses “Circle of Kindness” has entered into a controversy with the Ministry of Health. The department proposes to exclude the fund’s expert council from the decision-making process on the purchase of medicines and medical devices worth tens of billions of rubles. The Ministry of Health explains that “it is bringing the procedure for providing children with drugs through the Circle of Kindness in line with federal legislation, making it simpler, faster and more transparent, focused entirely on the interests of young patients.” The fund is confident that the adoption of the amendments, on the contrary, will lead to public dissatisfaction “due to the lack of transparency of the procurement procedure.” The “Circle of Kindness” makes it clear that the money allocated to help children is not part of state guarantee programs, that is, it is not included in the budget of the Ministry of Health, and therefore “society and specialists in the field of severe life-threatening and orphan diseases” should control their use.

The Ministry of Health of Russia has prepared amendments to the resolution of the Cabinet of Ministers on the work of the Presidential Fund for Helping Children with Severe Life-threatening, including Rare, Diseases “Circle of Kindness”. The document is in the public comment phase. Among other things, the Ministry of Health intends to exclude the fund’s expert council from the decision-making process on the purchase of medicines. Thus, in the draft resolution there is no mention of this structure, with the exception of one point: it was proposed to convene it to assess the validity of the use of “a complex type of medical care.” However, Alexander Tkachenko, Chairman of the Board of the Circle of Kindness, emphasizes that the concept of a “complex type of medical care” is not disclosed.

“Circle of Goodness” was created on January 5, 2021 by the decree of Vladimir Putin. The goal is to provide medicines and medical devices to patients under 18 with rare diseases due to a 2% increase in personal income tax for Russians whose annual income exceeds 5 million rubles. In 2021, Krug Dobrob purchased drugs for more than 2.1 thousand children, 60 billion rubles were reserved from the budget for this, and 75 billion rubles were actually allocated. The Fund buys, among other things, unregistered medicines. Until recently, the most expensive of them was the drug for the treatment of spinal muscular atrophy Zolgensma – 120 million rubles. for one dose.

The Fund’s Expert Council consists of 27 people: doctors (in particular, the head physician of the Morozov Children’s Hospital Valery Gorev, the head physician of the Children’s Clinical Hospital named after Z. A. Bashlyaeva Ismail Osmanov, the chief freelance specialist in medical genetics of the Ministry of Health Sergey Kutsev), public and religious figures, representatives charitable, scientific and educational organizations. Council headed by the President of the Center for Pediatric Hematology, Oncology and Immunology. D. Rogacheva Alexander Rumyantsev weekly reviews new applications for the provision of medical care, the provision of drugs and medical devices. Specialists evaluate the correctness of the treatment prescribed by the federal council or medical commission, including an assessment of medical indications and contraindications, as well as dosages and the need for a particular drug. “Now we are accepting applications for 2023 in order to have time to purchase medicines,” said Alexander Tkachenko. Last week there were 200, this week there are already 500. Then we expect 600-700 applications weekly.”

Medical assessment of independent and competent experts, members of the council, Mr. Tkachenko emphasized to Kommersant, ensures the correctness of appointments, objectivity and transparency of work. According to him, there are still few good specialists in rare diseases in the regions. Therefore, often the expert council returns applications to the regions due to “insufficient study of the analysis of the patient’s condition” or the absence of all necessary medical examinations. The amendments proposed by the Ministry of Health, Alexander Tkachenko warns, mean that the application, in whatever form it is received, will oblige the fund to make a purchase if there are no formal errors in the documents.

The Circle of Kindness, according to its representatives, did not participate in the discussion of the amendments, moreover, “for some reason, the ministry does not consider it necessary to make an expert assessment of the documents.” “But the fund is not an organization whose activities are considered within the framework of the law on protecting the health of citizens, and the funds that the fund allocates for the purchase of medicines and medical devices are not part of state guarantee programs (that is, they are not included in the budget of the Ministry of Health.— “uh”), continues Alexander Tkachenko. “Accordingly, the society, as well as specialists in the field of severe life-threatening and orphan diseases, should decide on the purchase of which drugs or products the funds allocated to the fund will be spent on.” Mr. Tkachenko sees the danger in the fact that “in the new scheme, any doctor in the region will make a decision” for hundreds of millions of rubles, without having the necessary qualifications.

At the same time, the terms for making decisions will be lengthened, the head of the Circle of Kindness predicts, since “due to the lack of control by leading experts”, there will be more errors in the documents. In addition, he continues, there will be public dissatisfaction “due to the lack of transparency of the procedure.” “It cannot be ruled out that doctors signing these prescriptions will become a target for attempts to influence pharmaceutical manufacturers,” suggests Mr. Tkachenko, meaning that manufacturers will promote their drugs in this way.

The Ministry of Health, on the contrary, states that the proposed changes are aimed at simplifying the procurement procedure and reducing the time it takes to receive expensive medicines or medical devices. “In accordance with the law, treatment is prescribed by the attending physician or a specially assembled council, while the expert council of the fund is not such,” Alexei Kuznetsov, assistant to the head of the Ministry of Health, emphasized in a conversation with Kommersant. of the Krug Dobra fund in accordance with federal legislation, makes it simpler, faster and more transparent, focused entirely on the interests of young patients.”

It should be noted that the work of the fund is now regulated by a decree of the President of the Russian Federation and government decrees. Paragraph 3 of the decree, in particular, regulates the functions of the expert council: “assessment of the presence of medical indications and the absence of medical contraindications for the provision of medical care and the provision of medicines, medical devices and technical means of rehabilitation.”

“On the one hand, there is logic in the amendments of the Ministry of Health: since there is a decision of the council, then, it would seem, what does the expert council have to do with it? Alexey Fedorov, an independent public procurement expert, comments on the document. “On the other hand, it is proposed to remove the necessary, in my opinion, validation tool, which, in fact, is the association of public doctors.” However, Mr. Fedorov draws attention, the will of the President is clearly expressed in the decree.

Academician Alexander Rumyantsev, Chairman of the Expert Council, is confident that the amendments proposed by the Ministry of Health will be critically evaluated by public, patient organizations and the professional community. He calls the fund’s work with orphan patients effective and systemic. As an example, the academician cites the situation with spinal muscular atrophy (SMA): in a year and a half, the foundation, with the participation of an expert council, not only provided treatment for all children, but also created a register of patients with SMA, expanding the number of known patients from 800 to 1.2 thousand. good” controls 53 diseases. Alexander Rumyantsev emphasizes that if the amendments are adopted, the fund will have to learn to function differently, and this will “worse the tactics developed under difficult conditions.”

Natalia Kostarnova

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