In order to implement resolution of the Cabinet of Ministers of Ukraine No.240 dated July 2, 2014 “On reference pricing for pharmaceutical products and medical devices which are bought at the expense of state and local budgets” the Ministry of Health of Ukraine developed and released for public discussions draft joint order of the Ministry of Health of Ukraine and the Ministry of Economic Development and Trade of Ukraine “On approval of Calculation procedure of wholesale release prices for pharmaceutical products”.
It is a reminder that since August 1, 2014 changes of wholesale release prices for pharmaceutical products included in the list, agreed by the resolution of the Cabinet of Ministers of Ukraine No. 1071 dated September 5, 1996, and for certain medical devices shall be declared.
In order to declare the change of wholesale release price for a pharmaceutical product the latter shall be calculated by the applicant for each pharmaceutical form, pharmaceutical strength and consumer package of a pharmaceutical product. Thereafter the State Inspection on Price Control of Ukraine presents its conclusion regarding economical feasibility of such calculation.
The draft provides implementation of external price referencing mechanism, based on the prices which are set in the country of their origin (producer country and/or pharmaceutical product applicant), the Republic of Bulgaria, the Republic of Moldova, the Republic of Poland, the Slovak Republic, the Czech Republic, the Republic of Latvia, Hungary and the Republic of Serbia; and internal referencing based on the prices in Ukraine as a arithmetic mean.
Besides the Draft Attachment contains the list of official web-sites of the stated reference countries which information about price levels in the foreign countries shall be used. It should be noted that in Serbia wholesale release price is fixed with 8% markup which shall be deducted during declaration of wholesale release prices in Ukraine. Earlier declared wholesale release price shall be regarded as the price in Ukraine.
It is offered to give possibility for the applicants to choose declaration mechanism based on the available or not available data about price levels in reference countries and in Ukraine. Thus the draft offers the following 2 mechanisms.
The calculation of the wholesale release price for a pharmaceutical product in the national currency of Ukraine can be made in the two alternative ways (at producer/applicant option) based on:
At that the price index of pharmaceutical products and material producers shall be the value which is calculated by the State Statics Service of Ukraine and which describes time changes in the field of pharmaceutical products and material production and is used during forecasting and monitoring of pricing procedures, review of national accounts system values calculation in a permanent price and provides possibility for international reconciliation.
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