Analysis of the toxicity, the biological equivalence of generic drugs in accordance with the legislative acts, which regulate this area are not possible. This was stated by Director of the Institute of management and translational medicine SMRC pediatric Hematology, Oncology and immunology. Dmitriy Rogachev, Svetlana Varfolomeeva February 13 at a press conference. The event is timed to the International day of children with cancer, celebrated on February 15.
“I have big pain and a big problem in relation to generic drugs, she said. – I never hid its position in this regard. We understand that using the same molecule may experience these or other substances, which enter into the composition of the medicinal product”.
Svetlana Varfolomeyev said that the specialists-oncologists working closely with the Ministry of health and Roszdravnadzor about this, and if you have any questions related to the quality of drug purification, the development of side effects, immediately inform these agencies. “The necessary pharmaceuticals for our patients available. The Council of physicians makes a decision about the use of drugs in respect of a child. We control what we treat children. Use only those that can count,” she said.
The decision not to use generics in the treatment of children with cancer was made at the VI Congress of pediatric oncologists of Russia in 2015. In the resolution of the Congress included an appeal to the government and the Ministry of health of Russia with a request not to limit the purchase of original products for the needs of pediatric Oncology. However, the Minister of health of the Russian Federation Veronika Skvortsova said that these drugs are interchangeable, having the same effect, the same bio – and therapeutic equivalence, as the originals. Statements of doctors, she explained their affiliations with major Western pharmaceutical companies.