Off-label drugs can be prescribed for the treatment of children

Amendments1 to the Federal Law “On fundamental healthcare principles in the Russian Federation” will come into force on June 29, 2022, allowing doctors to prescribe off-label drugs to minors, i.e. for indications not specified in their instructions for use.

It will be possible to include off-label drugs in the standards of medical care for children and clinical recommendations. The list of diseases or conditions in which the use of the off-label drug is allowed will be established by the Russian Government. Most likely, oncological diseases will also be included in this list.

If an off-label drug is prescribed, the consulting physician will be obliged to inform about the off-label drug used, its safety, expected effectiveness, the degree of risk to the patient, as well as about the patient’s actions in case of unexpected effects of the drug on the patient’s health.

Upon reaching the age of majority and before reaching the age of 21, a person suffering from the diseases or conditions included in the established list will be able to be monitored and continue treatment at the medical organization that provided him/her with medical care for such diseases or conditions until reaching the age of majority.

These changes are very important for Russian legislation and can improve the quality of medical care. Now, the current legislation does not contain any provisions that would regulate the status of off-label drugs.

1 Federal Law No. 482-FZ of 30.12.2021 “On Amendments to the Federal Law “On fundamental healthcare principles in the Russian Federation”