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The position of the Association of Representatives of International Pharmaceutical Manufacturers AIPM Ukraine regarding the new edition of the National List of Essential Medicines

With this document, the Association expresses the vision of the member companies regarding the new edition of the National List of Essential Medicines (hereinafter referred to as the National List) and its further content.

On March 25, 2017, Resolution No. 180 of the Cabinet of Ministers of Ukraine dated March 16, 2017, “On Amending and Recognizing Some Resolutions of the Cabinet of Ministers of Ukraine as Out of Validity,” came into force, approving the new edition of the National List of Essential Medicines.

In our opinion, the final version of the National List does not correspond to the defined concept and ideology of its creation, and raises a number of problematic issues that may have negative consequences for patients and the industry.

Thus, in accordance with the adopted changes, the National List acquires special significance in connection with the cancellation of the Resolution of the Cabinet of Ministers of Ukraine dated 05.09.1996 No. 1071 “On the procedure for the purchase of medicinal products by institutions and health care institutions financed from the budget”, and therefore it is supposed to be used as a basis for public procurement.

In addition, in accordance with the draft Law of Ukraine “On State Financial Guarantees for the Provision of Medical Services and Medicinal Products”, it is intended to establish a restriction according to which only those medicinal products that are included in the National list

At the same time, during the creation of the new edition, focusing only on the Basic List of Essential Medicines recommended by WHO led to the inclusion of the simplest and outdated medicines in the National List.

At the same time, the reference of the regulatory framework to the National List as a basis for public procurement and its future use for reimbursement purposes makes it necessary to include modern and effective medicines that are used in Ukrainian medical practice and are vital for patients.

Based on this and in order to avoid unnecessary delays due to the established complex procedure, we consider it necessary, in addition to those already available in the National List of Medicines, to initiate the issue of automatic inclusion in it of all medicines that:

1) available in officially approved treatment standards (forms, protocols);

2) provided for in the lists and programs of public procurement, including through international organizations;

3) intended for the treatment of rare (orphan) diseases, which is mandatory in accordance with the provisions of the Basic Law of Ukraine on health care.

4) available in international recommendations and consensuses.

The absence of such medicinal products in the approved National List and the cancellation of the Resolution of the Cabinet of Ministers of Ukraine dated 05.09.1996 No. 1071 “On the procedure for the procurement of medicinal products by institutions and health care institutions financed from the budget” endangers the procurement by medical institutions for their needs , as well as the implementation of regional programs by regional and local bodies, since the centralized programs of the Ministry of Health of Ukraine do not cover 100% of patients’ needs for these drugs.

In order to avoid the mentioned negative consequences, we propose to introduce an open discussion of the existing situation and to provide an opportunity to complete the formation of the National List, which would meet the requirements of the modern system of providing medical care, the introduction of which would avoid disorganization in the industry, guarantee continuity in the treatment of diseases and accessibility vital medicines for the future.