Ministry of Health Proposal to Adjust the Development Process of National Essential Medicinal and Pharmaceutical Products List

As of 07.09.2015 the Ministry of Health of Ukraine has published on its official website for public consideration the Draft Decree of the Ministry of Health of Ukraine «On Amendments Introduction to the Ministry of Health of Ukraine Decree from 24.05.2005 № 226».

The Draft offers to amend the National Essential Medicinal and Pharmaceutical Products List. In particular, the draft authors offer a new approach to the development of the National List. Thus, the authors believe that as a basis for the abovementioned list it is required to take the Standard Essential Medicinal Products List recommended by WHO, which particularly includes the medicinal products to be used in pediatric practice as amended.

The acting National List in its turn is developed in accordance with anatomic therapeutic chemical classification of medicinal products being recommended by WHO in the final version.

Moreover, the Draft offers such novelties in comparison with an acting version as the eligibility for the National List not only of the registered, but also unregistered medicinal and pharmaceutical products.

The Draft also proposes the structure of the National List which would contain the following lists of medicinal products and pharmaceuticals:

• The essential list which includes the most efficient, safe medicinal and pharmaceutical products with a high economic feasibility rate for pathological conditions of higher priority which are designated based on modern and prospective significance for the healthcare;
• Additional list which includes medicinal and pharmaceutical products for pathological conditions of higher priority requiring the specialized diagnostic or monitoring equipment and/or specialized medical aid, and/or specialists training. In case of doubts, such medicinal and pharmaceutical products may be included into the Essential List as additional products taking into consideration constantly high value or low efficiency of the expenditures in different conditions.

It is worth to mention that the Draft designates the peculiarities of the National List revision. Thus, the Expert Council on Development and Amendment of National Essential Medicinal and Pharmaceutical Products List was proposed to be renamed as Expert Committee on Selection and Usage of Essential Medicinal and Pharmaceutical Products, as well as the Regulation on Expert Committee activity to be redrafted.

The Expert Committee shall consist of the experts assigned for four years service based on competitive selection by the Minister of Health.

According to the Draft the Expert Committee is the prime mover behind the amendments for the National List which may adopted once in a year. The Expert Committee members should develop their proposals considering the actual version of the amended Standard Essential Medicinal Products List recommended by WHO and considering if necessary the population incidence, disease and death rate, and health industry standards.

The amendments match algorithm has also been transformed and in accordance with the Draft shall be as follows.

• Upon the results of evaluation of the National List current version the Expert Committee shall submit its recommendations and conclusions to the Ministry of Health. Upon the consideration of this data the Ministry of Health shall publish on its website the Draft Decision on Amendments Introduction to the Current Version of the National List. Herewith such Draft shall be additionally approved by the Cabinet of Ministers of Ukraine.

Please pay attention that in accordance with the current legislation the proposals on development and amendment of the National List, alongside with the Ministry of Health and the Cabinet of Ministers, should also be approved by the Ministry of Finance, the Ministry of Trade and Economic Growth after public considerations and disclosure in accordance with the acting legal regulations.

At the same time the Draft designates that the proposals for the National List revision may be submitted by the third parties. Such proposals should be submitted in the form of an application to the Expert Committee. Moreover, the Draft designates the information which should obligatory be indicated in the application, in particular: the title or the full name of the applicant; correspondence address; telephone/fax number; e-mail; short description of the proposal.

Such applications the Expert Committee shall review during two months from the date of their submission on a first-come first-served basis.

It is worth to mention that the development of this List is coming from the governmental initiative to harmonize the existing Lists of Medicinal and Pharmaceutical Products being subject to state cost control. In particular, currently such acting Lists actually duplicate one another:

• Approved by the Decree of Cabinet of Ministers of Ukraine as of September 5, 1996 № 1071 the List of Medicinal Products of national and foreign production which may be procured by health institutions completely or partially funded from state or local budgets;
• National List of Essential Medicinal and Pharmaceutical Products approved by the Decree of Cabinet of Ministers of Ukraine as of March 25, 2006 № 333;
• Obligatory minimal assortment (social oriented) of medicinal and pharmaceutical products for pharmacies approved by the Decree of the Ministry of Health of Ukraine as of December 29, 2011 № 1000.

Please note, that simultaneously at the Ministry of Health website the draft on annulling of obligatory minimal assortment of medicinal and pharmaceutical products approved by the Decree of the Ministry of Health of Ukraine № 100 has been published for public consideration.