The Ministry of health proposed to change the procedure for the inclusion of medicines in the list of drugs which can be procured by health facilities under trade names. However such a list, although the rules of its compilation have existed for several years, still has not appeared.The government will update the rules for the purchase of medicines under trade names for treating patients under the MLA. The Ministry of health issued a draft government resolution on the portal regulation.gov.ru. The Department has prepared this document on behalf of Prime Minister Mikhail mishustina — recall that in February of this year in the government discussed how to resolve the problems of drug supply as preferential recipients of drugs and regular patients. According to statements of doctors and patients ‘ organizations, for many patients must purchase medicines in brand names, while the existing legislation in the field of public procurement allows you to specify only the international nonproprietary name of the medicine (see “Kommersant” on March 7).The only way of statement and response agencies will now be electronic. The package of documents for the approval now in addition to the data on the bioequivalence of the drug and examination of the balance of risks and benefits of its application must include the results of pharmacovigilance, including data about efficacy and safety when changing products with different trade names within the same international nonproprietary names, as well as medical care standards and clinical guidelines supporting the need for its application. The examination of the application will not only engage members, but at least two of the main freelance specialist of Ministry of health, which specializiruetsya in the area of the drug. They, in turn, will have the right to collect expert opinions from the medical and pharmaceutical communities.The idea is to give medical facilities the opportunity to purchase specific drugs for the treatment of patients appeared long ago, the Chairman of the Union “Assistance to patients with cystic fibrosis” Irina Myasnikova, however, until now this procedure is quite complex. “In order to cure, the patient must consent to medical Commission, which operates a limited period of time, she says. As a result, if the drug is necessary to patient constantly, as, for example, in the case of cystic fibrosis, he is forced to apply it regularly”. One is a list of such drugs did not appear, although the government has released the rules for its formation in 2017. “In the absence of any practice of its content to assess the innovations of the Ministry of health is impossible”,— says Irina Myasnikova.However, according to him, it will be necessary also reform and the procedures on which the Ministry of health offers to start to be guided, first and foremost pharmacovigilance. “Pharmacovigilance allows you to monitor adverse effects of the drug when it has already been issued and used by a large number of people, but this is possible only if there is a convenient procedure for reporting to the regulatory body. Meanwhile, doctors in Russia prefer not to go to Roszdravnadzor, in order not to face charges in the address,” he says.Anastasia Manuylova
