The European Parliament has implemented new measures aimed at drastically reducing the risk of infected blood being passed-on in blood transfusions.
The measures put in place comprehensive and legally binding standards for blood and blood products from donor to patient and for related medical applications.
Included in the measures are requirements for testing, labelling and tracing of blood and blood products, for quality management systems in laboratories and other establishments handling blood and an EU-wide surveillance system.
Health and Consumer Protection Commissioner David Byrne welcomed today's adoption by the European Parliament of a Directive setting high quality and safety standards for human blood and blood products throughout the European Union. They aim to prevent blood contamination scandals similar to those that have occurred in some EU countries in the past.
The blood safety directive is the first legislation ever using the new Community competence in public health policy making which was introduced in Article 152 of the Amsterdam Treaty.
" . . .Europe's citizens can be confident that a high common standard of quality and safety of blood will be applied throughout the EU, and will be regularly updated with the assistance of the best available expertise," Mr Byrne said.
"This directive is an excellent example of how the EU can play a positive role in protecting and improving public health for European citizens."
The key requirements for blood management systems is that they conform to equivalent management and safety standards apply throughout the EU.
Staff working in such establishments and directly involved in the collection, testing, processing, storage and distribution of blood will have to be trained according to common EU standards.
The Directive complements existing EU legislation on medicinal products derived from blood. Since 1989, blood and plasma used for the manufacturing of plasma-derived medicinal products (i.e. albumin, coagulation factors, immunoglobulins) have been covered by EU pharmaceutical legislation.
Prior to the ratification of the Amsterdam Treaty, however, whole blood, cellular components and plasma used for transfusion were not.
Article 152 of the Amsterdam Treaty has given the Commission the legal basis to propose binding legislation, and provides for the adoption by Council and Parliament of measures setting high standards of quality and safety of blood and blood derivatives.
Starting in 2003 a Committee of national government experts chaired by the Commission will elaborate further technical detail for implementing the Directive and be responsible for updating provisions in view of new healthcare and scientific developments.