As a result of currency fluctuations at the market the Cabinet of Ministers of Ukraine has revised the mechanism of declaration of changes in the wholesale prices of medicines and medical products by adopting the Resolution “On Amendments to Some Resolutions of the Cabinet of Ministers of Ukraine” №449 of April 22, 2015. The Resolution has come into force on July 07, 2015.
The abolishment of reference pricing for the purpose of declaration is the main result of the Resolution’s adoption. Thus, upon the Resolution comes into force .price changes declaration shall be based on the product’s delivery price in Ukraine.
In addition, rejection of reference pricing has removed the State Price Inspection from the declaration process. The Ministry of Healthcare of Ukraine shall be exclusive public authority empowered to evaluate the completeness of the submitted documents, correctness of their execution and to make decision on medicines and medical products’ price declaration after the Resolution comes into force.
Reference pricing rejection results at the amendments of the list of the documents required for the declaration. For instance, explanatory note clarifying the need for changes and certificate on the price level in the reference states and in Ukraine will be removed from the list. Instead, after this Resolution comes into force a declaration and a power of attorney for medicines, a declaration, a power of attorney and a copy of a state registration certificate for medical products shall be enough for the wholesale price change declaration.
The Resolution also reduces decision period to 10 business days plus two extra days for publishing information at the web site. According to the effective Declaration Order of the Wholesale Price Changes of Medicines and Medical Products, approved by the Resolution of the Cabinet of Ministers of Ukraine № 240 of July 02, 2014 review period is 22 business days from the date of an application.
In addition, the Resolution does not set limits regarding frequency of wholesale price changes declaration.
Moreover, one of the novation of Resolution is that Ministry of Healthcare of Ukraine authorities shall be authorized to correct wholesale prices. Thus, if an average month rate of hryvnia to US dollar (set by the National Bank) is changed more than to 5 %, declared changes of wholesale price of medicines and medical products of foreign origin must be corrected by the Ministry of Healthcare of Ukraine. Hence, Ministry of Healthcare of Ukraine shall put corrected and declared changes of wholesale prices no later than on the 10thday of the following month to the relevant registers.
It shall be noted that the Resolution changes the price regulation procedure for medicines and medical products. In particular, a new method of the determination of the retail increments to the products of the minimum (social oriented) list, purchased for pharmacies, and of the National List has been adopted. The Resolution stipulates the maximum level of retail increments up to 25 % that is added to the purchase price including taxes. At the same time differentiated fixed increments for the products depending on the purchase price defined under the Resolution of the Cabinet of Ministers of Ukraine № 955 dated on 17.10.2008 were canceled.
Furthermore, the Resolution amends the Resolution of the Cabinet of Ministers of Ukraine № 333 dated on 25.03.2009 in regard with determination of an average rate. While according to the effective edition of the Resolution № 333 an average rate of hryvnia on the interbank foreign exchange market of Ukraine on the date of realization of products shall be taking into consideration, after Resolution № 449 comes into legal force, it shall be obligatory to consider an average rate of hryvnia, set on the interbank foreign exchange market of Ukraine on the date preceding the date of the products realization, to foreign currency, that is used for products purchase.
Consequently, order of price declaration of medicine and medical products has been significantly simplified and results at reduction of the uncertainties related to the procedure of price determination in reference countries.
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