On October 5, the Blood and Beyond initiative published a statement in response to the European Commission’s proposal for the Blood, Tissue and Cells Directive revision published on 14 July. Blood and Beyond welcomes the Commission’s proposal, in particular the focused objectives to facilitate the development of SoHO therapies and blood sector innovation that improves health outcomes; and to strengthen systems to provide safe and adequate allogenic blood, which is vital for patients who have no alternative treatment options. Blood and Beyond shared the following recommendations on the Commission’s proposal:

• The Regulation should take into account the broader context of the challenges it aims to tackle, including factors that impact allogenic blood demand, as well as measures and opportunities to reduce demand or improve use.
• The Regulation should be aligned with WHO guidance on Patient Blood Management.
• The new EU-wide data system in the SoHO sector should include indicators to stratify clinical use of blood and blood products per disease area/indication; and be connected with patient registries and surveillance systems in relevant disease areas.

Other issues covered in the Blood and Beyond recommendations include the new expert groups set up to guide the Commission’s work, and EU funding.

Access the full statement here.