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The Order on Supplying of People Suffered from Rare (Orphan) Diseases by Medicinal Products Has Come into Force

On April 2015 the Order of the CMU, dated 31.03.2015 N 160, came into force and established the Order on supplying of people suffer from rare (orphan) diseases by medicinal products and relevant food products for special dietetic application.

It should be reminded that since 01.01.2015 the amendments to the Law of Ukraine “Fundamentals of legislation of Ukraine on the healthcare”, entered by the Law of Ukraine, dated 15.04.2014 N 1213-VII, have come into force. In particular, the Article 53-1 of the Law of Ukraine “Fundamentals of legislation of Ukraine on the healthcare” was added and the paragraph 2 this Article set that people suffered from rare (orphan) diseases are supplied free and continuously by medicinal products and relevant food products for special dietetic application in accordance with the list and the scope established by the Ministry of Healthcare of Ukraine and in the order set by the CMU.

The order defines subjects and conditions for supplying of medicinal products and food products for special dietetic application, and establishes the register of citizens suffered from rare (orphan) diseases.

Such citizens will be supplied by products according to medical indications based on the decision of the commission of the Ministry of Healthcare of Ukraine (if products are bought using state budget funds and other legal sources) or the commission of regional and Kyiv state administrations (if products are bought using local budget funds and other legal sources) and written consent of citizen or his/her legal representative (as for children till 14 years and incapable persons).

The sore people will be able to receive products in healthcare facilities in accordance with the place of residence or treatment.

Nevertheless the issue is still open whether all citizens suffered from rare (orphan) diseases can receive vital medicinal products and food products for special dietetic application, because free and continuously supplying is planning to provide within budget assignments in the terms of financial possibilities of state and local budgets.

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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