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Natalia Modlenko Participated in the Roundtable Concerning the Conception of the National List of Medicinal Products

On April, 22 this year the roundtable was held concerning the discussion of the conception of the list of medicinal products, which may be purchased by state budget. The event was organized by the Ministry of Healthcare of Ukraine. Among participants there were the Deputy of the Minister of Healthcare Igor Peregynets, the representative of the State Expert Center of the Ministry of Healthcare of Ukraine, representatives of the project “Systems for Improved Access to Pharmaceuticals and Services” (SIAPS), the associate of Legal Alliance Company, Ukrainian and international business associations and patient organizations.

The main issue was the necessity of changing the lists of medicinal products existing in the country, in particular, the list set by the Order of the CMU, dated 05.03.1996 № 1071. At present the team of specialists has elaborated the draft of by the Order of the CMU on establishment the National list and the draft of Regulation on this list. The Ministry of Healthcare of Ukraine prosed for public discussion obsolete editions of mentioned documents. Natalia Modlenko notified that the last relevant draft edition includes the provision on state purchases in accordance with the new list of medicinal product in 2016.

The important topic for business associations and patient organizations was the issue of addition of the list based on WHO Model List of Essential Medicines by essential medicinal products for patients. As it was explained for roundtable participants, at present only the basic draft has been created and it is the ground for Ukrainian substitute. This list will be amended by the Expert Committee, which is supposed to be created after adoption of necessary legislation.

The associate noticed that according to the elaborated draft of the Regulation on the National list the member of the Working group will be elected by on competition basis pursuant to special criteria. The meetings usually will be closed in compliance with international practice. However, the market representatives will be able to participate in the discussion on amending the National list. The one exclusion is the meeting for voting. It is suggested that each procedure step will be published at official web-site of the Expert Committee and the Ministry of Healthcare of Ukraine (publication of applications, extracts from protocols, conclusions of the Expert Center and recommendations of the Ministry of Healthcare of Ukraine).

It should be reminded that this March Legal Alliance Company was elected as legal counsel for elaboration the set of documents on establishment of the National list for SIAPS project realization provided by the global non-governmental “Management Sciences for Health” using grants of United States Agency for International Development (USAID).

The project team is headed by partner Dmytro Aleshko, who has profound expertise on project performance concerning law-making in healthcare. Natalia Modlenko also is the member of team elaborating the new addition of the Law of Ukraine “On medicinal products” (N 2162).

Our Team

Dmytro Aleshko Managing partner, Attorney-at-law
Dmytro Aleshko
Andrii Gorbatenko Partner, Attorney-at-law
Andrii Gorbatenko
Vitalii Savchuk Partner, Attorney-at-law
Vitalii Savchuk
Lidiia Sanzharovska Associate Partner, PhD in Law
Lidiia Sanzharovska
Olexander Bondar Counsel
Olexander Bondar
Maryna Scherbak Senior Associate, Attorney-at-law
Maryna Scherbak
Maryna Tkachenko Senior Associate
Maryna Tkachenko

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