The Order of Ministry of Health of Ukraine № 84 dating from 02.11.2016, with which the Regulation on the National List of Essential Medicines and the Regulation on the Expert Committee on the Selection and Use of Essential Medicines has been approved will soon enter into force.
It is to be recalled that this document has been developed in response to the decision № 1134 of the Cabinet of Ministers dating from December 9th , 2015" On Amendments to the Decrees № 955 and № 333 of the Cabinet of Ministers of Ukraine dating respectively from October 17th, 2008 and March 25th, 2009.“
The legal support of the development and adoption of the abovementioned Order of Cabinet of Ministers, as well as the above-mentioned order of the Ministry of Health of Ukraine was provided by the Legal Alliance Company in cooperation with the SIAPS project.
The said provision establishes that the drugs will be included in the National List of Essential Medicines (hereinafter - the National List), taking into account population incidence rates, prevalence of disease and mortality, evidence of the comparative effectiveness (performance), safety and cost-effectiveness of medicines, as well as industry standards in terms of health and level of funding for health care. The structure and contents of national lists will be based on the latest edition of the Basic List of Essential Medicines recommended by WHO.
"The next working step is to create a competitive commission for the formation of an expert committee and the selection of committee members on the basis of equal access of candidates to participate in the competition. An important step forward is the need to study whether or not such persons present a conflict of interest, as well as the possibility of participation of foreign specialists with the necessary knowledge and experience in the selection process in the national list,"- said Dmytro Aleshko, who heads the team of experts developing a normative - regulatory package on this matter.
The Expert Committee will consist of 12-18 people, it will be composed of specialists with higher medical, pharmaceutical and economic education. Such persons shall not present a real conflict of interest, in particular, they should not be in an employment or any other contractual relationships with producers and holders of certificates of registration of drugs or associated persons. An important selection criterion is the presence of experience of the evaluation of the comparative efficacy (effectiveness), safety and cost-effectiveness of drugs.
Once an expert committee under the Ministry of Health of Ukraine is established, work concerning the selection of drugs to be included in the National List will be conducted by them. The drugs will be included in the National List for International Nonproprietary Names. National List updates will be carried out once a year.
Interested individuals and legal entities can apply with a package of necessary documents for inclusion of drugs in the National List of Medicines. To this end, the development and public discussion of the Regulation on the conduct of medicines selection for inclusion in the National List , which will be approved by order of the Ministry of Health of Ukraine, as well as the application form and its requirements is being continued.
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