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.
The European Commission collaborates closely with expert bodies such as the Council of Europe (CoE) and the European Centre for Disease Protection and Control (ECDC) in the development of practical guidelines that support blood establishments with the implementation of this binding legislative framework.
- The Council of Europe (CoE) regularly reviews and updates technical requirements in its Guide to the Preparation, Use and Quality Assurance of Blood Components and Good Practice Guidelines for blood establishments. In addition, it prepares ad-hoc guidelines on different topics, in regard to the safety and quality of SoHO.
- The ECDC prepares risk assessments and preparedness plans whenever epidemiological outbreaks are of relevance for blood, tissues, cells and organs. Most recently ECDC has provided input on:
Coordination and implementation
National Competent Authorities (CAs) 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 CAs, allow the European Commission to draft reports on the state of play of implementation of the legislation.
Vigilance is a key element of the regulatory framework for substances of human origin. EU legislation requires tissue and blood establishments, as well as transplant centers and hospitals, to notify their national competent authorities (CAs) about any serious adverse events or reactions in patients (SARE) that occurs.
CAs submit annual reports to the European Commission and based on these, the Commission prepares annual summaries on serious adverse outcomes in the EU. These reports and summaries provide a resource for improving donation and transfusion/transplantation practices in the EU. A dedicated vigilance expert sub-group is monitoring SARE reporting to maximise lessons learned.
The Commission also hosts a Rapid Alert System for Blood and Blood Components (RAB) and a Rapid Alert System for human Tissues and Cells (RATC), which provides an effective and secure tool for immediate exchange of information considered to have a safety or quality impact in two or more EU countries.
The Commission encourages national participation in the WHO's NOTIFY Library - a website where experts from across the globe share information on selected and documented adverse outcomes associated with the donation, processing or clinical use of human organs, blood, tissues and cells. The website's purpose is instructive, providing expert review and additional information on the records shown.
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.
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