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FAS approved a temporary increase in registered prices of 8 manufacturers

06.07.2020
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The issues of price regulation for vital medicines remains a heated issue for all participants in the healthcare system especially when it comes to the mechanisms that are necessary to ensure the presence of drugs on the pharmaceutical market.

"For the state and citizens, it does not matter which manufacturer leaves the market or comes to the market. It is important that the drugs that patients should receive do not disappear from the market and can be bought," said Nadezhda Sharavskaya, Deputy Head of the Department for Control of Social Sphere and Trade of the FAS Russia, as part of an online meeting with participants of the French-Russian Health Committee Chamber of Commerce.

Representatives of the antimonopoly service have spoken about registering the maximum selling prices for medicines in case of a deficit, including due to unprofitable production, which is set for the period of the threat of an emergency, as part of the implementation of the decree of the Government of the Russian Federation of April 3, 2020 No. 441, valid until December 31, 2020.

"In the framework of the procedure under resolution 441, only drugs included in the recommendations of the Ministry of Health on the treatment and prevention of COVID-19 are considered," said Daria Starykh, head of the drug price regulation department of the FAS Russia Social and Trade Control Department.

At the same time, the Law on the Circulation of Medicines provides for the possibility of adopting regulatory legal acts that would contain specifics for registering prices for any drugs from the list of vital medicines in the event of a defect due to unprofitability of their production. A draft of such a document was developed by the antimonopoly department and sent to the Ministry of Health of the Russian Federation.

"We believe that such a mechanism can be implemented if there is a defect in the whole drug: within one шnternational nonproprietary name and dosage. When conducting a comparative analysis, information on all trade names and the actual need for the drug should be taken into account," explains Nadezhda Sharavskaya. - "Besides, in our opinion, the decision to revise the price upward should be made for up to 1 year, and then be reviewed in accordance with the current rules and methods, that is, taking into account prices in reference countries and using decreasing coefficients, excluding earlier registered prices."

Source:

https://gmpnews.ru/2020/07/fas-odobrila-vremennoe-povyshenie-zaregistrirovannyx-cen-8-proizvoditelej...

http://publication.pravo.gov.ru/Document/View/0001202004060038