FAS PROPOSED TO UNILATERALLY EXCLUDE INFORMATION ABOUT MEDICINES THAT HAVE LEFT THE MARKET FROM THE PRICE REGISTER

Pharmaceutical manufacturers supported the authority's proposal

Daria Starykh, Deputy Head of the Department for Control over Public Health Service of FAS Russia, focused on this proposal during the session "Pricing for Medicines" at the Biotechmed forum.

On several occasions, FAS Russia has proposed to provide for the possibility of synchronizing and updating all databases with information about medicines. It is necessary both for customers when making purchases, and for supervisory authorities when exercising their powers. In particular, it is necessary to regularly update the information about medicines contained in the price register.

Currently, only manufacturers of medicines could exclude information about medicines that have left the market from this register. However, the pharmaceutical manufacturer does not always exclude the medicine from the relevant register when it is withdrawn from the market. Therefore, now there are medicines in it that have already gone out of circulation. FAS Russia considers it necessary to provide for the possibility for regulators to exclude them from the register unilaterally. For this purpose, it is necessary to make appropriate changes to the resolution on state regulation of prices for medicines from the list of vital and essential medicines*.

According to the Authority, pricing for other medicines, including those of domestic production, depends on it. When registering and re-registering prices for them, the applicant, the FAS Russia and the Ministry of Health of Russia are legally forced to focus on outdated prices of medicines that have left the market and contained in the register.

For example, the cost of reproduced medicines cannot be indexed annually above the price of the original medicine that has passed away. Only generics entering the market are obliged to reduce the price of a relatively outdated, in some cases unreasonably low price for the original medicine. It does not allow agencies to register prices for new medicines at the necessary economically reasonable level, taking into account current prices.

For reference:

* Resolution of the Government of the Russian Federation No. 865 of October 29, 2010 "On State Regulation of Prices for Medicines Included in the List of Vital and Essential Medicine"