Questions and Answers on EU regulation of blood and its derivatives

20 octobre 2021 Pierre Perrin-Monlouis

The Commission has today adopted new EU rules on the quality and safety of blood and blood derivatives, such as plasma, used in medical treatment. The measures adopted are part of the implementation of the EU’s Blood Directive, which was adopted by Parliament and Council in 2003
(see IP/02/1919 and MEX/03/0227).

Q: What power does the European Commission have to regulate blood?

The Amsterdam Treaty of 1997 gave the European Union a mandate to pass laws on the quality and safety of blood, human tissues and cells and human organs used in medical treatment (see Article 152 of the EC Treaty). The Commission put forward its first legislative proposals in late 2000 and the Blood Directive was passed by the European Parliament and Council in January 2003.

The Blood Directive sets EU-wide quality and safety standards for the collection, testing, processing, storage and distribution of human blood and blood components. The measures put in place comprehensive and legally binding standards for blood and blood derivatives from donor to patient and for related medical applications (see IP/02/1919).

The 2003 Directive gives the Commission a mandate to pass implementing measures. A first set of technical implementing measures was adopted by the Commission in March 2004. The two sets of implementing measures adopted today followed consultations with Member State authorities and health experts last year.

Q: Why is blood quality regulated by the EU rather than national governments?

EU countries need to be able to import blood and blood derivatives from each other to enable them to cope with shortages or dramatic surges in demand at national level (e.g. in case of a major disaster). Having a common set of high standards helps facilitate cooperation between healthcare systems. It also helps give Europeans confidence that if they go for treatment in another EU country they will be properly protected from blood born diseases. Day to day quality control of blood and regulation of organisations collecting, processing or storing blood still takes place at national and regional level.

Q: Why is the Commission issuing implementing measures so long after the Directive was passed?

The Blood Directive of 2003 established a general framework of principles and common rules. Developing detailed implementing measures to give these effect required a process of consultation and consensus building with government officials and blood safety experts from across Europe. Getting the technical details right has taken time.

Q: What are the new implementing measures?

One set of rules concerns the traceability of blood and blood derivatives, while the other concerns quality standards.

Q: What does the implementing measure on traceability do?

It puts forward rules on the traceability of blood and blood components through identification, recording and labelling procedures. It establishes a verification procedure for issuing blood and blood components, and details measures on recording data on traceability, on notification of serious adverse reactions and events, on requirements for imported blood and related components, on annual reporting and exchange of information between national authorities.

The traceability directive also sets up a notification system that enables Member States and the Commission to learn from any incident that takes place anywhere in the EU, even if this does not require any tracing of the defect products. The Directive includes the notification procedures and formats for reporting serious adverse events and reactions associated with the quality and safety of blood.

“Traceability” means the ability to trace each individual unit of blood or blood component derived thereof from the donor to its final destination, whether this is a recipient, a manufacturer of medicinal products or disposal, and vice versa. Member States shall ensure the traceability of blood and blood components through accurate identification procedures, record maintenance and an appropriate labelling system.

This will allow to identify each donor, each blood unit collected and each blood component prepared, whatever its intended purpose, and the facilities to which a given blood component has been delivered. All facilities will have to establish a system to record each blood unit or blood component received, whether or not locally processed, and the final destination of that unit, whether transfused, discarded or returned to the distributing blood establishment. Blood establishments, hospital blood banks, or facilities will have to keep relevant data for at least 30 years.

Q: What does the implementing measure on quality assurance do?

It puts forward standards and specifications of a quality system for blood establishments. This means any structure or body that is responsible for the collection and testing of human blood or blood components, whatever their intended purpose, and their processing, storage, and distribution when intended for transfusion. This does not include hospital blood banks.

The Directive covers aspects such as staff, organisation and premises, including requirements for collecting, testing, processing, storage and waste disposal areas. It addresses blood collection, testing and processing, including donor eligibility, collection of blood and blood components, laboratory testing, processing and validation, labelling, release of blood and blood components etc. It tackles provisions for inspection and auditing, and covers other aspects such as complaints, recall of blood batches and further corrective measures.

Q: What happens next?

The Commission will work with Member State authorities to ensure the new measures on traceability and quality of blood can be put in place smoothly. Member States have until 31 August 2006 to put in place national measures implementing the new rules.

The authorities of the Member States competent in blood matters will meet on 26 September 2005 in Luxembourg to discuss the progress made in the implementation of the Blood Directive and if any further measures are needed.

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