FAS request to pharmaceutical companies

The Federal Antimonopoly Service (FAS Russia) appeals to pharmaceutical companies manufacturing life-saving and essential medicinal drugs.

The State register of the maximum ex-work manufacturer prices for life-saving and essential medicinal drugs (the Price register) is an informational database used to estimate prices for state registration, to calculate wholesale and retail prices as well as in procurement of medicinal drugs, in analytical reports and reference information, etc. The Price Register has 29,000 entry records on the prices for life-saving and essential drugs without information about current prices and whether particular drugs are in circulation.

The Price Register currently has an enormous number of outdated entries with prices that changed long time ago or data on medicinal drugs that are practically not circulated in Russia.

For example, the maximum ex-works prices for “Panimum Bioral” (the International Non-Proprietary Name – “Cyclosporine”), “oral solution” drug formulation, is currently included in the Price Register; at the same time, No. R N011061/02 Registration Certificate of the drug expired on 27.10.2011, while the drug validity period is 3 years.

Obsolete data in the Register are confusing for all its users with regard to drugs availability and prices: regulators, controlling bodies, wholesale and retail sellers, public and municipal customers and the population.

Regulators are forced to account for non-existent prices in economic analysis for the purposes of price registration, which distorts estimates ad sometimes leads to unfair refusals to accommodate prices or make changes to the Price Register.  It also prevents objective analysis for the relevant decision-making. Obsolete data in the Price Register hamper effective work of government customers and controlling bodies.

Under Sub-Clause “a” Clause 7 of the Rules for Keeping the Price Register, approved by No. 865 Decree of the Government of the Russian Federation of 29.10.2010, information about state registration of the maximum ex-works manufacturer prices for medicinal drugs should be excluded from the Price Register when the drug manufacturer files an application to remove such information.

To update the Price Register, FAS asks holders or owners of Drug Registration Certificates to apply to the Ministry of Health Care of the Russian Federation to remove the obsolete entries from the Register, including entries on drugs that are not sold in Russia.