Human blood and blood components - maintaining standards

SUMMARY OF:

Directive 2002/98/EC – quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components

SUMMARY

Donations of human blood and plasma provide the basis for a wide range of essential, often life-saving, therapies. Blood and its components are also used for routine surgery to prolong a patient's life. Their quality and safety must be guaranteed to prevent any transmission of infection or disease.

WHAT DOES THE DIRECTIVE DO?

• It lays down quality and safety standards for human blood and its components to ensure a high level of health protection.
• It covers blood collection and testing and its processing, storage and distribution when used in transfusions.

KEY POINTS

EU countries 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.

WHEN DOES THE DIRECTIVE APPLY?

It entered into force on 8 February 2003. EU countries had to incorporate it in their national law by 8 February 2005.

BACKGROUND

Blood, tissues and organs on the European Commission's website.

ACT

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)

RELATED ACTS

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). Successive amendments to Directive 2004/33/EC have been incorporated into the original text. This consolidated version is of documentary value only.

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)

last update 24.11.2015