FAS IS DEVELOPING JOINTLY WITH THE RUSSIAN MINISTRY OF HEALTH DRAFT DECREE THAT WILL NOT ALLOW DISAPPEARANCE OF SCARCE MEDICINE

The document is designed to ensure the availability of low-cost life-saving medicine for patients

The FAS Russia together with the Ministry of Health of Russia is working on a document that allows indexing the prices of life-saving medicine, the production of which has become unprofitable.

“The project is currently being finalized and approved by the Federal Executive authorities. The initiative will mainly affect a small number of medicines 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 medicine from the list of VED would not rise. Moreover, the FAS Russia together with the Russian Ministry of Health is conducting a large-scale review of prices for life-saving medicine, which should be completed by the end of 2020. Already, as part of the review, the FAS Russia has agreed on more than 5 thousand producer prices for these medicine. The average reduction for reference medicine was 24.28%, for generics – 33.2%”.

It should be reminded that the problem of unprofitability of production of life-saving medicines was found by the FAS Russia in 2015, since the powers of the Federal Tariff Service were transferred to the FAS Russia. In particular, the current situation with the leaching of medicines in the lower price segment has 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 activities in the field of tariff regulation, the FAS Russia has repeatedly taken initiatives aimed at solving this problem. In particular, the new methodology and rules for registration (re-registration) of manufacturers' maximum selling prices for life-saving medicines developed with the direct participation of the FAS Russia contain a number of preferences for medicines of the lower price segment. For example, the current rules do not provide for the use of lowering coefficients for medicines worth up to 100 rubles, but allow annual indexation of registered prices for “double level of inflation”. However, as practice shows, not all pharmaceutical manufacturers use this opportunity every year.

To minimize the risk of inventory shortage of medicines in the low price segment this April, the FAS Russia made a proposal to provide for revision of prices of generics, the prices of which registered in 2010, based on indicative parameters, and provide the opportunity to review prices taking into account unused annual indexation.

Besides, in the framework of implementation of the Government resolution No. 441, the FAS Russia did not allow inventory shortage of a number of medicines included in recommendations of Ministry of Health of Russia on treatment and prevention COVID-19. The Agency agreed on 35 maximum selling prices for 18 trade names of medicines within 6 medical non-generic names (Hydroxychloroquine, Prednisolone, Heparin sodium, Paracetamol, Ambroxol, Enoxaparin sodium).