The draft federal law On Amending the Federal Law On Procurement of Goods, Works and Services for State and Municipal Needs was submitted by Federation Council member Boris Shpigel and State Duma Deputy Rinat Khayrov.
The submitted draft federal law has been considered by the Government.
The bill proposes excluding section 22 from Article 10 and amending section 33 of Article 34 of the federal law On Procurement of Goods, Works and Services for State and Municipal Needs (hereinafter - the Law).
Section 22 of Article 10 of the Law (in the version the federal law of July 20, 2012, No. 122-FZ, which entered into effect on July 23, 2012) prohibits combining different medicines with international generic names (hereinafter - IGN) or in the absence of such names, with chemical and group names, into a single contract (single lot), if the initial (maximum) contract price (lot price) exceeds the limit set by the Government, as well as medicines with IGN names (in the absence of such names, with chemical and group names) and trade names.
This provision is aimed at preventing unreasonable consolidation of contracts (lots) and promotes competition in the relevant markets.
Since this provision has not yet been sufficiently applied, its removal from the Law is premature.
Pursuant to Part 33 of Article 34 of the Law, medicine procurement auctions must specify in their paperwork the medicine's IGN, or, in the absence of IGN, the chemical and group names of the medicines.
The draft law proposes amending section 33 of Article 34 of the Law by specifying the medicines in the auction paperwork according to the Anatomical Therapeutic Chemical (ATC) Classification System, recommended by the World Health Organisation (WHO).
The ATC classification system has five levels (anatomical main group, therapeutic subgroup, pharmacological subgroup, chemical subgroup and chemical substance), which are used to determine the particular subgroup to which a medicine belongs. At the same time, the WHO recommends using IGN names at the substance level. The draft law, however, does not provide for using a specific level-based ATC classification for Government procurement purposes, which creates legal uncertainty in specifying the auction subject.
In addition, the wording of the proposed legislation does not comply with the terminology and concepts used in the federal law On the Circulation of Medicines regarding as pertains to using the ATC classification to regulate the circulation of medicines.
Therefore, the amendments proposed in the draft law contradict the existing approaches to regulation in this area.