Donations of blood and its components (red cells, platelets, and plasma) facilitate a wide range of essential, often life-saving treatments. Blood transfusions are essential when dealing with trauma or major surgery, and are often needed in cancer management, or to treat inherited chronic blood diseases such as Thalassaemia.
Donated plasma, a component of blood, can also be used to manufacture medicinal products like immunoglobulins or clotting factors. The manufacture of these products is subject to pharmaceutical legislation, while the donation, collection and testing of plasma is regulated by blood legislation.
The availability of blood, and blood components, is dependent on citizens' willingness to donate blood. Most people who are in good health can donate blood.
The legal framework defining the quality and safety standards for blood and its components is set out in Directive 2002/98/EC, also referred to as the European Blood Directive. It covers all steps in the transfusion process from donation, collection, testing, processing, and storage to distribution.
To help implement this main act, the European Commission proposed and adopted, in close collaboration with EU national authorities, the following additional implementing acts:
- Commission Directive 2004/33/EC on the technical requirements for blood and blood donation
- Commission Directive 2005/61/EC on the traceability requirements and notification responsibilities in case of serious adverse reactions and events
- Commission Directive 2005/62/EC that sets out Community standards and specifications relating to the quality system for a blood bank
It is important to note that EU countries can always choose to apply more stringent rules to the quality and safety of blood and blood products than those outlined above.
Following an evaluation of the EU legislation on blood and tissues and cells, published in 2019, the Commission plans to propose a revision of this legislation at the end of 2021.
National competent authorities are responsible for the implementation of EU legislation. The European Commission holds regular meetings with them to facilitate communication, to exchange best practices, and to reach a common understanding on the implementation of the Directives.
Periodic surveys, completed by the competent authorities, allow the Commission to draft reports on the state of play of implementation of the legislation.
The European Commission provides funding for actions in the area of SoHO through the EU health programme, mainly in the form of projects or joint actions with national authorities. Funding in this area is done also through the European Health and Digital Executive Agency (HaDEA).
Actions aim at supporting the EU mandate on safety and quality but can also serve to promote other policy priorities, such as improving the availability of SOHO or the efficiency of the health systems that support donation and supply. Some recent examples include:
- two guides on Patient Blood Management (PBM): one targeted for health authorities, the other for hospitals
- the Joint Action VISTART, to promote and facilitate the harmonisation of inspection, authorisation and vigilance systems for blood, tissues and cells
- Eurobarometer reports outlining the European public's attitude to blood and tissue and cells donation and transfusion and/or application
- Creative Ceutical Report - an EU-wide mapping exercise of the market for blood, blood components and plasma derivatives, focusing on their availability for patients
- Catie - Competent Authority Training of Inspections in Europe. The development of training sessions for inspectors in the field of blood and blood components
- EUOBU - a guide on EU Optimal Blood Use
- DOMAINE - a project to create a safe and sufficient donor population in Europe: comparing and recommending good donor management practice
- EuBIS - the development of pan-European standards and criteria for the inspection of blood establishments
- EU - Q - Blood SOP - the development of a pan-European standard operating procedure (SOP) for best practice in ensuring the quality and safety of blood