On May 25, 2015 the Draft Order of the Ministry of Healthcare of Ukraine “On Amendments to the Order of the Ministry of Healthcare of Ukraine “On Formation of Formulary System Provisioning of Healthcare Facilities with Medicinal Products” of July 22, 2009 No 529” was published on the official website of the Ministry of Healthcare of Ukraine for public discussion.
The Draft Order proposes, in particular, to clarify the operational aspects of the Central Formulary Committee (hereinafter – the “CFC”) by amending the Regulation, Governing its Formation and Operation.
First and foremost, the Draft Order unlike the most recent edition of the Regulation, specifies who should serve on the CFC. Therefore, the Draft Order refers the following to serve on the FCF: managers and/or staff of structural subdivisions of the Ministry of Healthcare of Ukraine on matters of medical care and quality of its provision; pharmaceutical activities, and managers and/or staff of National Academy of Medical Sciences of Ukraine, managers and/or staff of State Expert Center and other institutions subordinate to the Ministry of Healthcare of Ukraine. Provided that, it is obligatory for the above mentioned individuals to serve on the CFC.
Moreover, the Draft Order proposes to amend the management principles of the CFC. Thus, unlike the current edition of the Regulation, whereby Presidium is in charge of the CFC, the Draft Order prescribes that the CFC management should be vested in the Head at its sole discretion. Therefore, should the Draft Order be passed the management and coordination of activities will be consolidated in one man`s hands, namely in the hands of the Head of the CFC.
Provided that, the current edition of the Regulation in the same way as the Draft Order does not envisage any qualification requirements to the Head and does not provide details of the assignment procedure. Considering that the Draft Order proposes to consolidate plentitude of the power regarding the CFC in the Head, including proposals development concerning introduction of medicinal product to the State Formulary, review and renewal of the State Formulary, defining the referee process and public discussion of State Formulary or its separate chapters, the proposal to vest the coordination of activities of the CFC and its management in the Head defies check-and-balance system and conditions the possibility of corruption risks occurrence.
Furthermore, the Draft Order proposes to expand the list of subjects entitled to attend meetings of the CFC in an advisory capacity, and make such list exclusive. Consequently, the list includes individuals, save as provided in the current edition of the Regulation, representatives of medical professional associations, patient, and religious organizations. However, such individuals shall be invited at the initiative of the CFC.
It should be noted, that the Draft Order does not specify the selection criteria either for such organizations or their representatives, which might cause doubts of experts` independence. It remains unclear whether the invitation of aforementioned subjects is an obligation of the CFC or merely its right.
In addition, the Draft Order sets forth the rules of conduct in case of real or potential conflict of interest occurrence. Thus, should the members of the CFC or other meetings` participants face the aforementioned circumstances, they shall notify in writing hereof the Head of the CFC or its deputy, and should the Head or its deputy face such circumstances they shall notify in writing hereof the Deputy of the Minister of the Healthcare of Ukraine.
It should be noted, that the above-mentioned Regulation is to be evaluated positively as developed for execution and in compliance with the requirements of the new Law of Ukraine “On Prevention of Corruption” of 14.10.2015 No 1700-VII, effective 26.04.2015.
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