Children are asked to be treated like an adult – Newspaper Kommersant No. 211 (7412) dated 11/15/2022

The All-Russian Union of Patients complained to the Ministry of Health about the unreasonable delay in the permission to use “adult” drugs for the treatment of minors. Earlier, the government, after long negotiations, approved the requirements for the use of off-label drugs, and also formulated the conditions for their inclusion in the standards of medical care and clinical recommendations for children. But the decree will come into force only on September 1, 2023, which means that the possibility of treating children is postponed until at least 2024, warns the All-Russian Union of Patients. This situation can lead to “irreversible health consequences.”

As Kommersant said, at the end of June, important amendments to the law on health care came into force: they allow the use of “adult” drugs for children – outside the requirements of the instructions (off-label). Health care providers can now self-prescribe such drugs in three cases: when they are intended to treat diseases from a separate list; when the use of off-label is described in the standards of care for children and clinical guidelines; and when the drug meets the requirements set by the government.

Everything is in order with the first point: now 21 diseases are listed in the off-label list – oncological and oncohematological diagnoses; diseases of the blood, respiratory organs and endocrine system; malformations and chromosomal abnormalities. But the second and third points – the conditions for the inclusion of off-label drugs in the treatment standards and clinical recommendations, as well as the requirements for them – have not yet come into effect. Only in November, the government published a draft of the corresponding decree. According to the document, inclusion in standards and recommendations is possible if the effectiveness and safety of use are confirmed by clinical studies and (or) scientific research data published in leading scientific journals, and in relation to each deviation from the instructions. Or if, according to clinical or scientific studies, the off-label drug has a higher efficacy while maintaining safety or a higher safety while maintaining efficacy.

It is assumed that the decree will come into force only on September 1, 2023. Therefore, the All-Russian Union of Patients (VSP) appealed to the Ministry of Health with a request not to delay the application of the new rules in order to avoid “serious consequences”. The authors of the appeal point out that the law “On the Fundamentals of Protecting the Health of Citizens” prohibits the inclusion of off-label drugs in clinical recommendations before the document comes into force “due to the impossibility of establishing the compliance of the drug with the “requirements established by the government””. As a result, the possibility of using off-label drugs in minors is delayed until at least 2024 due to the long lead times for the development and approval of recommendations and standards.

“This can lead to irreversible consequences for the health of patients,” the patient organization notes. The authors of the appeal quote from the explanatory note to the resolution: “It is impossible to organize the treatment process of patients without the use of off-label drugs, which is especially important when providing medical care to children with serious illnesses, where the proportion of use of such drugs reaches 60–70%.”

In addition, the GSP asks to waive the requirement that the efficacy and safety of off-label drugs must be confirmed by publication in journals “indexed in international databases.” Patients suggest using a “more flexible approach” and taking into account scientific publications indexed in Russian information and analytical systems. They explain this by the “current geopolitical situation”, when the publication of the results of research by Russian scientists in foreign publications is “significantly difficult” and there are risks of stopping the indexing of individual Russian publications “for political reasons”.

Anton Emelin, senior partner of ICA Aronov & Partners, notes that the use of off-label drugs “is made dependent on conditions that are difficult to implement in practice.” He emphasizes that now we are talking only about drugs registered in Russia, but even among them, not all of them can be included in the standards and clinical recommendations. In addition, the issues of adopting standards and clinical recommendations “are a long process, and it is not certain that they will be adopted at all.” “Thus, the possibility of using off-label drugs is currently extremely difficult to implement,” Mr. Emelin states. But at the same time, the very possibility of their use has now decreased to almost zero.

Anastasia Gavrilova, a lawyer at BGP Litigation, recalls that it remains possible to apply off-label by decision of the medical commission – at least until they are included in the standards and clinical recommendations. And for drugs that are not included in clinical recommendations, the possibility of prescribing through a commission will also remain, Ms. Gavrilova is sure. However, a member of the Russian Bar Association, Dmitry Uvarov, points out that due to legal gaps, the decision of doctors to prescribe such a drug is “almost always due to the risk” of criminal prosecution. For example, under the articles “Causing death by negligence” (Article 109 of the Criminal Code of the Russian Federation), “Causing grievous harm” (Article 118 of the Criminal Code of the Russian Federation) or “Provision of services that do not meet safety requirements” (Article 238 of the Criminal Code of the Russian Federation). Thus, the issue of prescribing off-label, especially for the treatment of children, has not yet received its clear regulation, the lawyer says.

“Already today, in accordance with the law, off-label drugs can be prescribed to patients by decisions of medical commissions, regardless of whether they are included in clinical recommendations or not,” the Ministry of Health commented on the VSP appeal. The department added that following the results of public discussion, the draft resolution could be finalized, “including taking into account the opinion of the patient community, which will be comprehensively considered.”

Natalya Kostarnova