Adoption of the draft law on treatment of rare (orphan) diseases

On April, 15, 20014, the Law of Ukraine ‘On Introduction of Amendments to the Framework Legislation of Ukraine on Health Protection for Prevention and Treatment of Rare (Orphan) Diseases’ was adopted.

By way of the present document the notion of ‘rare (orphan) disease’ was introduced. It is foreseen that the life-threatening or chronically debilitating disease cuts short human life or causes disability which occurrence among the nationals is not more frequent than 1:2000.

The Law # 2801- XII of 19.11.1992, Framework Legislation of Ukraine on Health Protection, is amended by way of article 53-1 stipulating that the state shall ensure the action for prevention of rare (orphan) diseases and organization of the corresponding medical assistance to the nationals that suffer rare (orphan) diseases. For the present purpose, the Ministry of Health

Protection of Ukraine shall be entrusted with the action below:

• define and approve the list of rare (orphan) diseases and ensure official publication of the present list;
• create and ensure functioning of state registry of nationals that suffer rare (orphan) diseases;
• define the action required to ensure prevention of rare (orphan) diseases and establish the procedure for providing medical assistance to the nationals that suffer these diseases.

By way of the document the right of the nationals that suffer rare (orphan) diseases for continuous and free-of-charge receipt of medications that are required for treatment of these diseases and the corresponding special diabetes food in line with the list and in the volumes that are approved by the Ministry of Health Protection of Ukraine as prescribed by the Cabinet of Ministers of Ukraine.

To ensure functioning of new provisions the Parliament of Ukraine shall additionally introduce amendments to the law on State Budget of Ukraine while the Ministry of Health Protection of Ukraine shall approve the procedure for free-of-charge provision of the corresponding medications to the nationals as well as the list and the volumes of diabetes food.