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The Long-awaited Success on the Way toward European Model of Essential Medicines List

On January, 12 the Cabinet of Ministers Resolution № 1134 as of 09.12.2015 came into force, which amended the Cabinet of Ministers Resolution № 955 as of 17.10.2008 «On Efforts in Stabilization of Prices for Medicinal Products and Medical Devises», and the Cabinet of Ministers Resolution № 333 as of 25.03.2009 «Certain Issues of State Regulation of Prices for Medicinal Products and Medical Devices».

In such a way, the National List of Essential Medicinal Products and Medical Devices has been renamed into the National Essential Medicines List. Therefore, the medical devices shall not be included into this list anymore and shall not be subject to pricing regulation.

Since CMU Resolution № 333 as of March 25, 2009 adoption, the list has not been amended with any medical device. Prior to this Resolution adoption the list approved by the CMU Resolution № 400 March 29, 2006 was in force containing 783 products among which only 1 product was a medical device – test system. Before 2006 the list approved by the CMU Resolution № 1482 as of November 16, 2001 was acting. This list aimed at the monitoring of manufacturers’ and suppliers’ prices for vital domestically produced medicinal products and medical devices, world market prices for such products of foreign manufacture, their customs values. The list also contained only those products that had ATC-code. Therefore, the National Essential Medicines List did not function properly from the very beginning of its development.

National Essential Medicines List should be formed with due consideration of world-wide practices of rational pharmacotherapy and pharmacotherapeutic approach to primary health care of patients with priority pathologic conditions taking into consideration disease burden and mortality rate, and health care sector standards.

In the majority of countries this function is fulfilled by the WOH Model List of Essential Medicines, which has been elaborated as a core document for ensuring public health care at government expense. The essential medicines are selected with regard to the morbidity rate, comparative effectiveness and safety evidence, economic efficiency. These medicinal products should be available at hospitals and outpatient facilities at any time, in good supply, in relevant dosage forms, and of a guaranteed quality taking into account the peculiarities of health care system.

It is worth to mention that «Legal Alliance» Company is a partner of SIAPS and is responsible for policy development within the framework of the project, in particular for elaboration of the new version of National Essential Medicines List.

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Dmytro Aleshko Managing partner, Attorney-at-law
Dmytro Aleshko
Andrii Gorbatenko Partner, Attorney-at-law
Andrii Gorbatenko
Vitalii Savchuk Partner, Attorney-at-law
Vitalii Savchuk
Lidiia Sanzharovska Associate Partner, PhD in Law
Lidiia Sanzharovska
Olexander Bondar Counsel
Olexander Bondar
Maryna Scherbak Senior Associate, Attorney-at-law
Maryna Scherbak
Maryna Tkachenko Senior Associate
Maryna Tkachenko

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