Harmonising Blood Legislation

On 31 March 2026, a working meeting was held at the Ministry of Health of Ukraine within the framework of the EU-Ukraine Twinning project “Support the establishment of the state control authority for medicines and medical devices.” The meeting focused on analysing legal discrepancies in Ukrainian legislation related to blood and blood components in the context of alignment with European Union legislation — a key step in Ukraine’s path toward EU membership.

The meeting brought together Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, and Daumantas Gutauskas, Director of the National Blood Center of Lithuania, together with Twinning experts and representatives of the Ministry of Health of Ukraine.

During the meeting, experts presented the results of a legal analysis of Ukrainian legislation governing blood and blood components. Three key legal discrepancies were identified that need to be addressed to align Ukrainian legislation with the EU acquis and support Ukraine’s EU integration process.

Principle of voluntary and unpaid donation

The first discrepancy concerns provisions allowing monetary payments to plasma donors for fractionation purposes. According to Regulation (EU) 2024/1938, donations of substances of human origin must be voluntary and unpaid, while compensation may only cover justified expenses incurred by the donor.

Participants emphasized that aligning this provision with EU legislation is an important step toward bringing Ukraine’s regulatory framework closer to European standards. In particular, it was proposed to replace the concept of “payment” with the principle of financial neutrality, which allows only reimbursement of objectively justified costs related to donation.

Participation of public and private entities

The second discrepancy concerns inconsistencies between the law and licensing rules regarding the participation of public and private entities in blood collection activities.

Experts stressed the need to clearly define the roles of different actors to ensure a transparent and effective system compatible with European regulatory practices. It was proposed that the collection of blood and blood components for transfusion remain under public responsibility, while plasma collection for fractionation may involve private entities under clearly defined regulatory conditions.

Plasma fractionation and EU internal market principles

The third discrepancy relates to a legislative requirement that effectively limits plasma fractionation to the territory of Ukraine. Such a provision may restrict cross-border cooperation and conflict with EU internal market principles, particularly the freedom to provide services.

Experts recommended moving from a territorial approach to a regulatory oversight model, allowing plasma fractionation by any licensed and GMP-compliant operator, provided that traceability, safety requirements, and supply guarantees are ensured.

Next steps

Participants agreed that addressing the identified discrepancies is essential for further alignment of Ukrainian legislation with EU law. The recommendations developed by Twinning experts will support legislative reforms and contribute to building a modern regulatory system for blood and blood components in Ukraine in line with European Union standards.