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Russian FAS and the Russian Ministry of Health are developing a project which will prevent the disappearance of deficit medicines

The document aims to ensure the availability of inexpensive essential drugs for patients.

The Russian competition commission, together with the Russian Ministry of Health, is working on a document that allows indexing prices for vital drugs, the production of which has become unprofitable.

"Currently, the project is being finalized and coordinated between the federal executive authorities. The initiative will affect a small number of drugs, whose prices were registered in 2010 and have not been indexed since then, - explains Timofey Nizhegorodtsev, Deputy Head of the FAS Russia. - Prices for other drugs from the VED list will not rise. Moreover, the competition commission, together with the Russian Ministry of Health, are carrying out a large-scale revision of prices for vital drugs, which should be completed by the end of 2020. Already, as part of the revision, the FAS Russia has approved more than 5 thousand manufacturer prices for these drugs. The average reduction for reference drugs was 24.28%, for generics - 33.2%".

FAS Russia outlined the problem of unprofitable production of vital drugs back in 2015 after the powers of the Federal Tariff Service were transferred to it. In particular, the current situation with the leaching of drugs in the lower price segment is of a systemic nature and is directly related to the registration of prices for them in 2010 by fixing prices in the second half of 2009. Therefore, throughout its activity in the field of tariff regulation, the competition commission has repeatedly come up with initiatives aimed at solving this problem. In particular, the new methodology and rules for registration (re-registration) of the maximum selling prices of manufacturers for vital drugs, developed with the direct participation of the FAS Russia, contain a number of preferences for drugs in the lower price segment. For example, the current rules do not provide for the use of reduction factors for drugs costing less than 100 rubles, but allow for the annual indexation of registered prices by "double inflation rate". However, as practice shows, not all pharmaceutical manufacturers use this opportunity every year.

To minimize the risk of defective products in the lower price segment, in April of this year, the FAS Russia proposed to provide for a revision of prices for generic drugs, prices for which were registered in 2010, based on indicative parameters, as well as provide an opportunity to revise prices taking into account the unused annual indexation.

Besides, as part of the implementation of Government Decree No. 441, the FAS Russia did not allow a deficit of a number of drugs included in the recommendations of the Russian Ministry of Health on the treatment and prevention of COVID-19 to develop. The department has agreed 35 maximum selling prices for 18 trade names of drugs within six medical generic names".

Source: https://fas.gov.ru/news/30634