And it was treated as always – Newspaper Kommersant No. 160 (7361) dated 09/01/2022

The new law, which allowed the use of “adult” drugs for the treatment of children outside the instructions, in fact, only exacerbated the problem. According to the law, drugs can be prescribed off-label only if there is information about them in clinical guidelines and standards of medical care. But the Ministry of Health has not yet prepared these standards, and clinical recommendations for some rare diseases do not exist at all. And if earlier drugs outside the instructions could still be prescribed to children by decision of the medical commission, now, as they admit in the Ministry of Health, the law does not allow this. Experts are confident that doctors continue to prescribe “adult” drugs to children, but warn that this has become more dangerous from a legal point of view.

On June 29, changes to the federal health law came into force, allowing the use of off-label drugs (outside the instructions) in children. Initially, it was assumed that they would affect only oncological and oncohematological patients. However, the government list includes 21 diseases, including neoplasms, diseases of the blood, respiratory organs and endocrine system, malformations and chromosomal disorders, COVID-19, diseases of the nervous system, bone marrow donation (for patients under 18), pregnancy, childbirth and the postpartum period, as well as conditions requiring palliative care.

The need to find a “legislative solution” to the problem of using off-label drugs was the first to be announced by the specialists of the Dmitry Rogachev Center. They were supported by the leaders of the largest children’s cancer centers in Moscow and St. Petersburg, as well as oncologists in Yekaterinburg, Orenburg, and Kamchatka. The doctors explained that not a single instruction of the anticancer drug contains an indication of the possibility of using it for children with oncological diseases. That is, in fact, 80–90% of their treatment is possible only off-label. And when the law was adopted and entered into force, the Ministry of Health said: “This will improve the quality and availability of medical care for children with serious illnesses.”

But, as Kommersant found out, two months later the law did not work. “The problem is that in the law “On the Protection of the Health of Citizens”, the very prescription of such drugs was conditioned by the presence of information about them in clinical recommendations and standards of medical care. This regulation has already entered into force. But there are no clinical recommendations and standards yet,” says Alexei Fedorov, an independent public procurement expert and lawyer.

“For many rare diseases, we simply do not have clinical recommendations,” Mr. Fedorov continues. “Moreover, even if they appear, and even if there are off-label drugs, the government decree provides for the gradual entry into force of clinical recommendations. If these documents are adopted today, they will come into force only from 2024.”

For some diseases, clinical guidelines already exist, but the standards of medical care have not been changed there. Mr. Fedorov states: if before the prescription of off-label drugs was a gray area and was regulated, for example, by the decision of a medical commission, now it is formally frozen. This was confirmed by the Ministry of Health in response to a request from Mr. Fedorov. “As for the question of the possibility of using an off-label drug before it is included in the standards of medical care for children and clinical recommendations, in accordance with the current legislation of the Russian Federation, there is no such possibility,” the department’s letter says (Kommersant has it).

Aleksey Fedorov has no doubts that doctors continue to prescribe drugs to children outside the instructions, but notes that legal risks for them have increased significantly. “It is not known what will happen if a negative effect suddenly occurs – deterioration in health, death of the patient. How will law enforcement look at it? After all, they are inclined to a more formal interpretation: there is a norm of the law, it has been violated and harm has been done to health, ”the expert argues. He believes that the Ministry of Health should not have “so rigidly” tied the prescription of drugs outside the instructions to the presence of references to them in the standards and clinical guidelines.

“Obviously, the problem is not in the law itself, but in the incorrect legal technique for implementing legal norms,” agrees Polina Gabay, vice-president of the Together Against Cancer foundation of anti-cancer organizations, lawyer. label, it is impossible to prepare and adopt standards in one day. Accordingly, the need for a transitional period was also clear in advance. In which, for example, it would be permissible to prescribe drugs outside the instructions in accordance with clinical guidelines until the requirements and standards of medical care are adopted. But no one foresaw such a period. According to the expert, the Ministry of Health, in fact, recognizing the regulatory error, “confused” the subjects of healthcare – and “untimely” shifted the responsibility for any actions in a situation of uncertainty to them. “There is an incident of the legislator. A brilliant initiative by the Dima Rogachev Center and State Duma Vice Speaker Irina Yarovaya, but the adopted progressive law worsened the conditions in the industry as a result,” says Ms. Gabay.

The Ministry of Health told Kommersant yesterday that the professional community is working on updating clinical guidelines: “The updated versions adopted by the scientific and practical council under the ministry form the basis of current standards for the provision of medical care.”

Natalia Kostarnova