Draft Regulations Aimed to Reform Price Situation at the Pharmaceutical Market Is Released to Public

16.06.2014 the Ministry of Healthcare of Ukraine released for public consultations amended draft regulations of the Cabinet of Ministers of Ukraine “On Amendments to Some Regulations of the Cabinet of Ministers of Ukraine” (hereinafter referred to as “Draft”).

The draft was developed in compliance with the Cabinet of Ministers of Ukraine instructions No. 14442/0/1-14 dated 17.04.2014 regarding fulfillment of point 7 of the Minutes of Meeting dated 09.04.2014 “On Reforming of Healthcare System and Price Situation at the Pharmaceutical Market”.

According to the explanatory note regulations adoption will allow to:

• outline in a new version of the National List of Essential Drug Substances and Medical Devices (hereinafter referred to as “National List”);
• assert state regulation of prices for drug substances registered in Ukraine and included in the National List;
• exclude essential minimum assortment of (socially-oriented) drug substances and medical devices for pharmacies (hereinafter referred to as Minimum Assortment) from the state price regulation field.

Thus it is offered to exclude the Minimum Assortment from the influence area of the Regulations of the Cabinet of Ministers of Ukraine dated No. 955 dated 17.10.2008 “On Measures Aimed to Stabilize Prices for Drug Substances and Medical Devices”. Amount of trade mark-ups to purchase prices for drug substances included in the National List is unchanged.

By amending the Regulation of the Cabinet of Ministers of Ukraine No. 333 dated 25.03.2009 “Certain Issues of State Price Regulation for Drug Substances and Medical Devices” it is offered to approve new version of the National List (464 items with the account of all stated therapeutic categories and presentations) based on the current version of WHO Model List of Essential Medicines. At the same time the document is attached with the list of drug substances to be included in the National List provided they are registered in Ukraine (260 items with the account of all stated therapeutic categories and presentations).
According to the current legislation all regulatory acts shall be subject to public consultations, which provides possibility for all the parties concerned to provide their offers regarding the documents within thirty days from the publication date.