On 15 February 2022, Ukrainian Parliament passed a law introducing legal framework for the compassionate use of medicinal products for patients with serious or life-threatening conditions (the "Law"). Compassionate use programs ("CUPs") are well known in the EU and the U.S. and seek to provide access to unauthorized new treatment options where no authorized alternative therapy exists.
The Law provides for the following two types of CUPs: (i) expanded access program ("EAP") and (ii) post-trial access ("PTA") program. Below we present a table summarizing the key features of, and requirements, to, such CUPs, as established by the Law.
The Law remains to be signed by the President of Ukraine and officially promulgated to become effective. Further the Ministry of Health would need to develop and approve detailed subordinate regulations to make CUP mechanisms operational in Ukraine.
An important expected development is that products and services covered by CUPs should be exempted from VAT and personal income tax. Relevant bill is pending consideration by Parliament.
For further information, please contact Asters' Counsel Viktoriya Podvorchanska