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On December 22, 2017 Legal Alliance Company held a workshop for the pharmaceutical market “Pending Changes of State Regulation System for Medicinal Products’ Prices”.
Dmytro Aleshko, Partner, Natalia Lavrenova, Counsel, and Natalia Modlenko (Spivak), Associate of Legal Alliance Company, answered the questions raised by the participants of the workshop.
The speakers’ reports were focused on the changes, taking effect from January 1, 2017 and related to setting ceiling (reference) prices, maximum markup rates and the reimbursement of the cost of the medicinal products, which will take effect on April 1, 2017. Further, the plan to develop a new National List of Medicinal Products, the role of international organizations in determining a model of price regulation and possible ways of the current situation development, given regulatory changes, were discussed.
It is well known that in late November the Cabinet of Ministers of Ukraine issued Resolutions No. 862 and No. 863 regarding regulation of medicinal products’ prices. These documents introduce reimbursement of cost of the medicinal products used for hypertensive diseases, bronchial asthma and diabetes of the second type treatment (a total of 21 international non-proprietary names - “21 INPN”).
Dmytro Aleshko noted: “Resolution of the Cabinet of Ministers No. 862 was adopted in the wording which allows for various interpretations thereof. On December 8, 2016 the Cabinet of Ministers made amendments to the above Resolution and renewed control of markups on medicinal products in the wholesale and retail trade. However, in order for control system to work in full, the Ministry of Health should quickly approve orders, establishing the procedure for calculating the maximum prices and determining markups”.
Amendments to Resolution of the Cabinet of Ministers of Ukraine No. 862 as of November 9th,2016, which provide for state regulation of markups on medicines included in the National List of Essential Medicinal Products, came into effect on December 31st, 2016.
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