WHAT IS THE AIM OF THE DIRECTIVE?
- Directive 2002/98/EC lays down quality and safety standards for human blood and its components to ensure a high level of health protection.
- The directive covers blood collection and testing and its processing, storage and distribution when used in transfusions.
KEY POINTS
European Union (EU) Member States must ensure that:
- blood is collected and tested only by designated, authorised, accredited or licensed establishments with suitably qualified personnel.
- the establishments have quality systems in place, maintain the necessary documentation on operational procedures and guidelines and are inspected at least once every 2 years.
- blood and blood components can be traced from donor to recipient and vice versa and the data are kept for at least 30 years.
- any serious adverse events arising from accidents or errors are notified to the competent authority.
- prospective blood donors are given suitable information, such as details of the procedure involved and the opportunity to change their mind, and must provide personal data, such as their health history.
- the necessary measures are taken to encourage voluntary and unpaid blood donations.
- the data collected, including genetic information, are rendered anonymous so the donor cannot be identified.
- a blood donation report is sent to the Commission every 3 years.
Lastly, blood establishments must evaluate all blood donors, test each donation (to check if a donor has hepatitis B or C, for instance) and ensure proper storage, transport and distribution of the donated blood.
Repeal
Directive 2002/98/EC will be repealed and replaced by Regulation (EU) 2024/1938 (see summary) as from 6 August 2027.
FROM WHEN DO THE RULES APPLY?
Directive 2002/98/EC had to be transposed into national law and apply the rules by 8 February 2005. These rules came into effect on the same day.
BACKGROUND
For further information, see:
MAIN DOCUMENT
Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (OJ L 33, 8.2.2003, pp. 30–40).
Successive amendments to Directive 2002/98/EC have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (OJ L 91, 30.3.2004, pp. 25–39).
See consolidated version.
Commission Directive 2005/61/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards traceability requirements and notification of serious adverse reactions and events (OJ L 256, 1.10.2005, pp. 32–40).
Commission Directive 2005/62/EC of 30 September 2005 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards Community standards and specifications relating to a quality system for blood establishments (OJ L 256, 1.10.2005, pp. 41–48).
See consolidated version.
