The Russian government has developed a number of measures to improve the treatment of children with cancer, Prime Minister Mikhail Mishustin said at a specialized meeting, RIA Novosti reports .
Deputy Prime Minister Tatyana Golikova said that the Ministry of Health intends to lift restrictions on foreign drugs for cancer patients. At her request, Mishustin instructed Roszdravnadzor to organize control over the pharmaceutical market of drugs for cancer patients to ensure there are shortages.
“We often learn about shortages [of medicines] from doctors, from parents after the fact, but we need to act proactively. I believe that here Roszdravnadzor should monitor <...> and very promptly inform both the government leadership and <...> the Ministry of Health, and doctors in the relevant hospitals,” the head of government noted.
The Prime Minister did not specify exactly what measures the government had developed. “Such cases” turned to Roszdravnadzor for detailed explanations of the pharmaceutical market control mechanisms and which drugs would be affected.
Updated at 7:46 p.m. Russian Prime Minister Mikhail Mishustin instructed the Ministry of Health to make proposals for changes to laws on the use of unregistered drugs for children with cancer by April 14, RIA Novosti reports .
The French company Servier announced on February 14 that it had begun preparing a registration dossier for the drug Oncaspar (pegaspargase), which is the main one in the treatment regimen for all lymphoblastic leukemia. Since the fall of 2019, Oncaspar has been imported into Russia under the regulations for unregistered drugs - as prescribed by a medical commission or at the expense of charitable organizations.
In August 2019, the registration of Oncaspar was canceled at the request of the manufacturer, the German company Medac. The decision was due to the fact that since 2018, the rights to Oncaspar, along with Shire’s portfolio of oncology drugs, were transferred to the French Servier.
In February, the Russian Ministry of Health published a statement in which it explained the reasons for the interruptions in the supply of drugs for the treatment of leukemia. According to the department, the interruptions occurred due to a temporary cessation of supplies of the pharmaceutical substance cytarabine.
In November 2019, Development Director of the Gift of Life Foundation Ekaterina Chistyakova reported on an acute shortage of Onkaspar in Russia. According to her, the drug has been re-registered and instead it is necessary to purchase an unregistered analogue abroad.
Despite the fact that the Ministry of Health in 2011 developed a scheme for the purchase and delivery of unregistered drugs to Russia, regional clinics “do not want to get involved” with ordering unregistered drugs through official channels, Chistyakova said.