The Federal Antimonopoly Service (FAS Russia) warned the Ministry of Health Care of the Russian Federation to eliminate signs of unreasonably preventing operations of pharmaceutical companies (Clause 2 Part 1 Article 15 of the Federal Law “On Protection of Competition”(1)).
At the end of 2016, FAS established that the Ministry of Health Care unreasonably refused to execute Clause 6(1) of the Rules for keeping the Register of medicinal drug prices (2). In particular, the Ministry refused to make amendments to the Register entry of a pharmaceutical manufacturer on state registration of the maximum ex-works price of a medicinal drug when its package content is changed (provided the quantity of the drug in the secondary (consumer) packaging) remains unchanged).
The Antimonopoly Service revealed that the Ministry of Health Care acts selectively, making different decisions on similar applications. In February 2016 FAS already issued a similar warning to the Ministry.
Head of FAS Department for Control over Social Sphere and Trade, Timophey Nizhegorodtsev pointed out:
“The norm violated by the Ministry of Health Care is aimed at decreasing excessive administrative barriers, reducing the timeframe of launching medicinal drugs into circulation and preventing an unreasonably growth of prices for the drug, prices for which were already registered”.
The Ministry of Health Care must execute the FAS warning by 13 January 2017, by considering all relevant applications and making changes to the Register entries on drug prices under Clause 6(1) of the Rules for keeping the Register of medicinal drug prices.
1. Federal executive bodies <…> are prohibited to pass acts and (or) exercise actions (omissions that lead or can lead to preventing, restricting, eliminating competition <…>, including: unreasonably preventing economic activity of economic entities, particularly by setting requirements to goods or economic entities not provided for by the law of the Russian Federation.
2. The Rules for keeping the Register of the maximum ex-works manufacturer prices for the medicinal drugs included in the list of vital and essential drugs, approved by No. 865 Decree of the Government of the Russian Federation of 29.10.2010.