On 04.11.2016 the following bylaws became effective: the Ministry of Health Order № 1049 of 07.10.2016 «On Amendment of the Regulation on Expert Committee on the Selection and Use of Essential Medicines»and the Ministry of Health Order № 1050 of 07.10.2016 «On Approval of the Regulation on Medicines’ Selection for National Essential Medicines List».
Upon the enforcement of the amendments to the Regulation on Expert Committee the list of specialists allowed for the participation in Expert Committee has been extended. In particular, the specialists with mathematical education have been granted with the right to become members of this Committee. Moreover, the provision has been cancelled requiring from the candidates to be obligatory employed by healthcare or science and research facilities. Nevertheless, it is envisaged that preference will be granted to candidates working at these facilities during the selection of Expert Committee members by the Competition Commission.
At the same time, the Regulation on Medicines Selection to National Essential Medicines List provides the exact terms and procedures for the revision of the National List by the Expert Committee, in particular:
1) until October 01 of the current year to review the list of priority diseases, illnesses and conditions taking into consideration the designated criteria;
2) until November 01 of the current year to review the National List for the next year in compliance with the designated list of priority diseases, illnesses and conditions, the latest version of Essential Medicines Model List recommended by WHO, industry standards of healthcare (unified clinical healthcare protocols, State Formulary), elaborated in consideration of the outcomes of the budget impact analysis;
3) until April 01 of the year following the current year the Expert Committee Secretariat shall accept for consideration the applications on amendments to the National List;
4) until June 01 of the year following the current year to consider the applications, make the relevant decisions and submit the recommended version to the Ministry of Health.
The abovementioned Regulation also covers the specifics of the application execution regarding the National List amendment and approves the application template. Thus, the document in particular provides the details on which information should be filled in each application clause.
It should be mentioned that the hard copy and electronic version (in Word format) of the application should be submitted in Ukrainian, and the attached documents should be submitted in Ukrainian or English with Ukrainian or Russian translation (if required) as hard or electronic copies.
The legal framework development for the elaboration of National Essential Medicines List ends with the enforcement of the Regulation on Medicines Selection. The National List itself shall be harmonized with the latest version of WHO Essential Medicines Model List, which includes the medicines needs for a basic healthcare system. Therefore, the National List implementation shall provide for the removal of duplicates of different obligatory for usage medicines lists, in favor of single unified list to be implemented for public regulation of medicines prices.
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