After a two-year evaluation process, assessing whether the Directives on blood (2002/98/EC) and tissues and cells (2004/23/EC) are still fit for purpose, the European Commission confirmed the revision of the EU Blood Directive in its work programme 2021. The legislative proposal is expected in Q4 2021. The review aims to allow for a more flexible framework, aligned with scientific and technological developments.

The evaluation also identified gaps and challenges, namely out of date technical provisions and challenges to keep pace with technical development and innovation, suboptimal oversight provisions, incomplete protection of donors and limited provision to ensure self-sufficiency of blood and components.

The Commission published a roadmap on 17th of November outlining possible policy options to be considered to move forward with a revision. All stakeholders and citizens are invited to share feedback on the roadmap through an online public consultation open until the 14th December. Further information can be found here.