03-12-2020 | 12:54

The Decree of the Government of the Russian Federation No 1771 approves the procedure for setting economically reasonable prices for medicines that are in short supply due to low registration prices

“The purpose of the Decree is to compensate for the shortage of vital medicines of any price group and to provide the healthcare system with all the necessary medicines,” Timofey Nizhegorodtsev, Deputy Head of the FAS Russia, comments. “If the Ministry of Health of the Russian Federation and Roszdravnadzor, according to the requirements of the Order No 1771, determine the shortage of a drug within one International Nonproprietary Name (INN), and its reason is the price, it allows indexing this price to an economically justified level, but not higher than the prices for the same drugs established in the reference countries”.

During the implementation of the Decree, the antimonopoly authority has already made positive decisions on the coordination of prices declared by manufacturers of drugs with INN Azathioprine and Lomustine. It should lead to the elimination of their deficit. The latter was included in the list of 26 deficient cancer medicines.

“The prices for these medicines were registered back in 2010 at a very low level. For example, the minimum price for Lomustine in Russia was 10 times lower than the prices for it in European countries. It did not allow the manufacturer to supply the medicine to Russia in the required volume,” Timofey Nizhegorodtsev explains.

It should be remined that the current reason for the withdrawal of medicines from the pharmaceutical market is of a systemic nature and is largely associated with the unprofitability of their production and supply, which were due to the fixation of prices for them in the period from 2010 to 2013. In other words, we are talking about medicines that have been on the market for a long time. It was to prevent the shortage of such drugs that the Decree of the Government of the Russian Federation No 1771 was directed.

After reviewing the prices of drugs with INN Vincristine, it was found that manufacturers submitted incorrect information to the Ministry of Health of the Russian Federation and Roszdrvnadzor regarding the prospects for the volume of entering of medicines into civil circulation at current prices. Thus, Roszdravnadzor did not establish the presence of a shortage of the drug therefore, the authority did not have a basis for price indexation under the Decree No 1771.

“This week, the antimonopoly authority, jointly with the Ministry of Health of the Russian Federation and Roszdranadzor, held a meeting with the participation of Vincristine producers on their application of the Decree No 1771. In particular, they were informed about the importance of the most correct (conservative) assessment of the capabilities of their own production at current prices. The quality of decisions and the availability of vital medicines for patients largely depends on the reliability and correctness of the information provided by manufacturers to the authorities,” the Deputy Head of the antimonopoly authority stressed.

In case of repeated submission to the department of documents for prompt revision of prices for medicines with INN Vincristine, the FAS Russia will promptly review them according to the requirements of the Decree of the Government of the Russian Federation No 1771.

It should be noted that when conducting an economic analysis of the prices presented, the FAS Russia takes into account information on the actual and planned production volumes of medicines at the current registration price. This information is collected by Roszdravnadzor from all medicines manufacturers under one International Nonproprietary Name.

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