The Research Service of the Verkhovna Rada of Ukraine has prepared a parliamentary study on the legislative framework governing standards for the quality and safety of donated blood and its components in Ukraine, the European Union, and selected European countries. The study presents the results of an analysis of Ukrainian and EU legislation in this field, including the provisions of the Law of Ukraine “On the Safety and Quality of Donated Blood and Blood Components”, in the context of Ukraine’s obligations under the Association Agreement and the approximation to the EU acquis.

Particular attention is given to Regulation (EU) 2024/1938, which establishes updated standards for the quality and safety of substances of human origin (SoHO). The study also examines the state and trends in the development of legislation in this area in selected European countries, including Austria, Poland, Portugal, Czechia, and Switzerland. The findings indicate ongoing digitalisation of blood donation processes, strengthened regulatory oversight, and adherence to the principles of voluntary and unpaid donation. At the same time, the introduction of a unified national blood donor register remains a relevant issue for Ukraine.

Based on the study, key directions for further alignment of Ukrainian legislation with EU standards have been identified, including the implementation of Regulation (EU) 2024/1938 and the development of digital solutions in the field of blood donation. The full text of the study is available via the link:

https://research.rada.gov.ua/uploads/documents/34124.pdf