On 19 March 2021, the Ukrainian parliament amended the Law of Ukraine “On medicines” in part on the emergency-use authorisation for the COVID-19 vaccines and biologics.
When authorised by the Cabinet of Ministers, this will allow the Ukrainian Ministry of Health to take contractual obligations on behalf of Ukraine for the procurement and use of the COVID-19 vaccines and biologics authorised for emergency use, including:
a waiver of state immunity, and
releasing from liability the manufacturers and/or marketing authorisation holders, including their staff, as well as healthcare professionals, and other persons involved in vaccination-related activities, in relation to any consequences caused by using approved (on-label) COVID-19 vaccines and biologics.
All damages will be compensated according to a procedure to be separately developed by the Cabinet of Ministers of Ukraine.
This piece of legislation will remain in force for four years.
The amendments will probably intensify the ongoing negotiations and contracting with the COVID-19 vaccines manufacturers and consequently speed up the vaccine roll-out in Ukraine. It also aligns the Ukrainian legislation with the COVAX Facility terms and conditions.
For more information related to the emergency-use authorisation for COVID-19 vaccines and biologics, please contact your regular CMS advisor or local CMS experts: Anna Pogrebna, Naida Shykhkerimova, Borys Danevych.