On August 7 the teleconference was held with the participation of foreign experts from «Management Sciences for Health» organization (Washington). In the course of the conference the key methodology principles for medical products shortlisting to the National List have been discussed.
Among the participants of the teleconference were international SIAPS experts, professional associations’ representatives, Legal Alliance Partner Dmytro Aleshko and Legal Alliance Lawyer Nataliya Modlenko whose team works on the development of the National List.
It would be appropriate to remind that international non-profit organization «Management Sciences for Health» (MSH) implements international technical assistance project in Ukraine «Systems for Improved Access to Pharmaceuticals and Services» (SIAPS) with financial support from the United States Agency for International Development (USAID).
Within the teleconference the Ministry of Health of Ukraine was represented by Tetyana Dumenko the Director of Sustainable Pharmacotherapy and State Formulary System Monitoring Directorate.
In the course of the event Oksana Lebega, the representative of SIAPS program, talked on the development status of legal documents on the National List of Essential Medicines. In particular, Mrs. Lebega explained the structure of drafted documents among which there was the Draft for Amendments Introduction to Cabinet of Ministers of Ukraine Resolution № 333 on the exclusion of National List of Products for Medical Use name, the Draft Resolution of Cabinet of Ministers of Ukraine on approval of National List of Essential Medicines, as well as the Draft for Amendments Introduction to Ministry of Health of Ukraine Order № 226. It is planned to approve with the last mentioned document the Regulation on National List of Essential Medicines (Requirement to application on changes introduction to the National List, Requirements for reporting and annual statements of Expert Committee as an attachment); Expert Committee Regulation (membership application forms for Expert Committee candidates and its participants on the absence of conflict of interests as an attachment); and Regulation on the Procedures for Medicines Shortlisting to National List.
During the presentation Mrs. Lebega informed that a new National List is planned to be adopted after forming the Expert Committee based on Ministry of Health of Ukraine Basic List of Essential Medicines taking into consideration Ukrainian health system requirements and the funding level (designation of priority areas). The pursued goal is to implement state procurements in accordance with the new list starting from year 2016.
It is planned to consider such criteria of inclusion or exclusion to the National List as population infection rate, morbidity and mortality rates (according to Ministry of Health); evidence of comparative efficiency, safety and economic viability; medical products stability in different conditions; demand for special medical products and devices required for diagnostics or treatment (for medicines); pharmacokinetics properties of medicines; World Health Organization’ recommendations on essential drugs usage. According to the developed documents unregistered medicines shall also be included into the National List with a special remark about the absence of registration. Such drugs will be available for procurement only after their public registration in Ukraine. The inclusion of these drugs into the National List shall serve as a guide for the state and manufacturers regarding health system requirements.
Oksana Lebega also informed the participants on the requirements to application forms on the changes introduction to the National List and admitted that detailed shortlisting process will be described in the Regulation on the Procedures for Medicines Shortlisting to National List which is being drafted at the moment. This Regulation is supposed to give answers to the majority of market actors’ inquiries that occur in the course of discussions according the development of a new National Essential Medicines List.
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