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The evaluation also identified gaps and challenges, namely out of date technical provisions and challenges to keep pace with technical development and innovation, suboptimal oversight provisions, incomplete protection of donors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.
Members of the European Parliament Sirpa Pietikäinen (EPP) and Tomislav Sokol (EPP) inquired in a written question to the European Commission on 1st July 2020 regarding whether the Commission will re-open the EU Directive 2002/98/EC on human blood and blood components. The question also relates to measures to support greater implementation of Patient Blood Management (PBM) in Europe. MEPs further ask whether the Commission would welcome initiatives and funding proposals to establish a European Network of Centres of Excellence that supports PBM education and implementation.
Health Commissioner Kyriakides responded on behalf of the European Commission on 26th August 2020, explaining that a comprehensive evaluation concluded that the legislation has brought significant improvements to safety and quality of substances of human origin. The evaluation also outlined gaps and shortcomings that emerged over time. The Commission is now considering possible options for addressing these issues and will launch a public consultation and consult with the sector on the best way forward. The Commission has further funded a contract to develop guidance on Patient Blood Management. You can read the full answer here.
Furthermore, Member of the European Parliament and Chair of the Committee on Industry, Research and Energy Cristian-Silviu Buşoi (EPP) tabled a written question to the Commission on 22nd July 2020 regarding measures to support optimal blood use in Europe which also inquires whether the Commission will propose an EU Action Plan on Blood. The question also relates to upcoming EU policy schemes and how these will contribute to facilitating improvement in clinical education and practice and how research and innovation focusing on blood sustainability and improving patient outcomes can be supported.
Health Commissioner Kyriakides responded on behalf of the European Commission on 3 September 2020, noting that the EU legislation on blood, tissues and cells published in October 2019 brought significant improvements to the safety and quality of blood but that further improvement is needed – especially in the wake of COVID-19, where the issue of blood supply was raised as a key topic. The Commission is currently considering options for addressing these issues and has also made funding available to support increasing capacity of convalescent plasma collection, supporting a study of convalescent plasma as a COVID-19 treatment, and developing further guidance on Patient Blood Management. Further actions addressing the topic could take place within the EU4Health programme and the research programme, Horizon Europe. You can read the full answer here.