The State Duma adopted in the first reading a bill allowing off-label drug use in the treatment of seriously ill children, the press service of the State Duma reports. According to one of the authors of the bill, Deputy Chairman of the State Duma Irina Yarovaya, the patients concerned include those with cancer, rheumatological, haematological, or nervous system diseases, as well as with a number of other conditions.
It is explained that the use of off-label drugs is due to the fact that no alternative therapies are available, and there are no post-registration trials that could expand the patient population to which the medicines can be administered.
“Today, most of the instructions for the use of antitumor drugs in the world do not contain indications for the possibility of their pediatric use, i. e., children with cancer, rheumatological, haematological, or nervous system diseases, as well as with a number of other conditions, are currently treated solely on the basis of off-label drug use. Thus, without the use of off-label drugs, it is impossible to cure children with severe chronic diseases,” Irina Yarovaya said.
“We have done a lot of joint work with the Government of the Russian Federation, which helped us to reach a fully shared understanding of the fact that the proposed approach and procedures for off-label drug use for children with cancer and children with hematological diseases can be considered in a broader context, which will solve some of the related problems that exist in the provision of medical care to children in general,” she added.
Yarovaya emphasizes that off-label drugs included in clinical recommendations or prescribed by a medical commission “will be allowed for treating children, subject to the established procedure for mandatory notification of the patient.” Before starting off-label drug use, the attending physician must inform the patient or their legal representative about the drug, the expected effect of the treatment, the safety of the drug and the degree of risk to the patient.
“The novelties proposed by the draft law have been discussed and supported by leading Russian pediatric specialists and form pediatric procedures and treatment options that are accommodating, safe and adjusted to the general system of medical care,” the explanatory note to the bill says.
The bill also offers a solution to the issue of ensuring the continuity and integrated approach to the treatment of a disease with the onset in childhood, i. e., after reaching the age of 18, a teenager can continue to receive treatment in a children’s center where it was started.
