FAS: DATABASES WITH INFORMATION ABOUT MEDICINES NEED TO BE SYNCHRONIZED

It is necessary both for customers when making purchases, and for control and supervisory authorities when exercising their powers

Such databases should have end-to-end aggregation of characteristics, which will automate the calculation of the initial maximum contract price and other information. It was said by Elena Kloster, Head of the Health Control Department of FAS Russia, during the antimonopoly forum "Competition 2023".

Besides, the authority plans to work out the issue of revising the format and improving the list of vital and essential medicines. Its formation and management should be carried out according to groups of dosage forms aggregated by the mode of medicine administration.

Based on the proposals of the competition authority, the Ministry of Health of the Russian Federation has already prepared a number of amendments to the decree of the Government of the Russian Federation on the formation of the list of vital and essential medicines* regarding the maintenance of such list taking into account the generalized names of dosage forms. In 2022 at the initiative of the authority 35 pharmaceutical forms of medicines equivalent to those included in it earlier were additionally included in the list. According to FAS Russia, the expansion of this mechanism will contribute to the development of competitive environment in the markets for the circulation of medicines and prevent unjustified circumvention of the requirements of price regulation.

In addition, within the framework of the event, the results of FAS economic analysis and coordination of the maximum selling prices of manufacturers for drugs from the list of vital and essential medicines were announced. Therefore, in 2022, the authority analyzed more than 9 thousand prices, which is more than 2 times higher than the annual average since 2015, excluding a one-time revision of all prices in 2020.

It ensured the launch of new medicines to the market and the preservation of existing ones by indexing and setting economically reasonable prices for deficit medicine in accordance with Resolution No. 1771**. Taking into account the prevailing economic conditions, in order to optimize the re-registration procedures, FAS Russia has also developed amendments to this Resolution. A number of such changes have already been made by Resolution No. 444***, the rest are under consideration by the Ministry of Health of Russia.

* Decree of the Government of the Russian Federation No. 871 of August 28, 2014 "On Approval of the Rules for the Formation of Lists of Medicines for Medical Use and the Minimum range of Medicines necessary for the provision of medical care".

** Decree of the Government of the Russian Federation No. 1771 of October 31, 2020 "On Approval of the Specifics of State Regulation of Manufacturers' Maximum Selling Prices for Medicines Included in the List of Vital and Essential Medicines, and Amendments to Certain Acts of the Government of the Russian Federation".

*** Decree of the Government of the Russian Federation No. 444 of 03/23/2022 "On Amendments to the Specifics of State Regulation of Manufacturers' Maximum Selling Prices for Medicines Included in the List of Vital and Essential Medicines".