Specializing ministry developed and published for public consideration the Draft Resolution of CMU «On Reference Pricing for Medicinal Products».The document has been developed under the instruction of the Government. Therewith, the CMU actions plan by 30.09.2016 envisages the new pricing principals implementation aimed at reducing budget expenses at tenders up to 30%.
The CMU Draft Resolution foresees that since 01.08.2016 the declaration shall be fulfilled under the new procedure, and all wholesale-retail prices declared under currently acting procedure should be re-declaredby01.10.2016.
It is provided that MOH of Ukraine should establishastandingcommissiononmedicinalproductspricesregulation, which shall decide on the relevance of wholesale-retail prices’ level of declared medicinal product and on the possibility of its inclusion into the register of wholesale-retail prices. Commission shall be composed of the representatives of Ministry of Economic Development, Ministry of Social Policy and Ministry of Finance of Ukraine.
Wholesale-retail prices fororiginalforeign medicinal products are proposed to be designated according to the minimal price (and not according to arithmetic average as previously) of one of the reference countries (country of first registration, Bulgaria, Moldova, Poland, Slovakia, Check Republic, Latvia, Hungary, Serbia). In addition, there is no mechanism for prices declaration for original native products.
There are two proposed declaration procedures for generic products:
1) If there is a declared price for a reference original medicinal product in Ukraine, the wholesale-retail price for generic product should be 20% less;
2) If there is no declared price for a reference original medicinal product in Ukraine, the submitted for declaration price:
The package of documents required for submission should include the declaration, statement on prices level and power of attorney. For foreign manufacturers the declaration currency shall be Ukrainian hryvnya. The term for documents processing shall take 25 business days.
Therewith, there is a number of issues, in particular:
From the existing today procedures for wholesale-retail prices declaration there is left the provision left regarding the automatic correcting by the Ministry of Health of the declared prices level, in the case of currency fluctuations. It is worth to mention that currently this provision cannot be implemented, as the procedure of such correcting is not established.
It also should be noted that according to the current CMU Resolution as of July 2, 2014, № 240, the wholesale-retail prices for medicinal products purchased under international procurements procedure (centralized procurements) are not subject to mandatory declaration. At the same time, in the newly developed by the Ministry of Health draft procedure such exception is absent.
In case the Government approves the draft resolution the specializing ministry would require adopting a number of orders:
Moreover, these or other orders would need to approve the declaration form, statement template for the information on prices level and data sources regarding the level of prices in reference countries.
It is also worth to mention that the draft resolution does not provide for the declaration procedure for wholesale-retail prices for medical devices.
As the developed procedure for wholesale-retail prices declaration requires the clarification of certain mechanisms, we hope that in the nearest future the representatives of pharma community shall have an opportunity to participate in the follow-up revision of this draft resolution.
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