On 17 August 2015 the Ministry of Health of Ukraine made available for public discussion the Draft Resolution of the Cabinet of Ministers "On Amendments to the Draft Resolution of the Cabinet of Ministers of Ukraine No.333 dated 25 March 2009"
The Draft Law seeks to amend the National List of Essential Medicines and Medical Devices. In particular, this legislative initiative provides for deleting medical devices from the title of the List.
The need for these amendments arose from the fact that none of the medical devices were actually added to the List since the date of its creation. Accordingly, the current title of the National List does not correspond to the actual situation.
Note that the National List of Essential Medicines and Medical Devices approved by the Resolution of Cabinet of Ministers "On Certain Issues of State Regulation of Prices for Pharmaceutical Products and Medical Devices" was adopted with the aim to determine the list of domestic and imported medicines as well as medical devices whose prices are under state regulation.
Today, as per part 1, paragraph 1 of the Resolution of the Cabinet Of Ministers of Ukraine No.333 which is currently in force wholesale markup limit for medical devices contained in the National List is set at 10% of wholesale price inclusive of taxes and charges while the limits on retail markups are set at 25% of purchase price inclusive of taxes.
Therefore, since medical devices are not included into the National List, the aforesaid provision of the Resolution of the Cabinet of Ministers of Ukraine has never been enforced.
Besides, adoption of the Draft Law stems from the plans to create the National List based on the WHO Model List of Essential Medicines which does not encompass medical devices either.
In case that proposed amendments are approved the Ministry of Health of Ukraine shall be obliged to adopt certain regulations aimed at implementation of these amendments within one month since the date on which the Resolution comes into legal force. To be precise, within the term indicated above the Ministry shall adopt the following regulations:
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