WRITTEN QUESTION E-2636/97 by Ursula Schleicher (PPE) to the Commission (1 September 1997)

Subject: Safety of blood and plasma products

A substantial number of manufacturers of plasma derivatives have now taking far-reaching measures aimed at further increasing the safety margin with these products. These initiatives comprise the following measures for plasmapheresis donors:

- cutting out one-off donors, resulting in the sole use of qualified donors;

- introduction of a minimum storage period of 60 days for plasma, together with monitoring of donors over this period;

- using genetic engineering test procedures (genome amplification) to detect viruses transmitted by blood and plasma. This will significantly reduce the risk of donations being obtained during the 'diagnostic window' phase, i.e. the risk of plasma with an undetected infection entering the manufacturing process.

1. Is the Commission aware of this voluntary action?

2. What is the Commission's view of these measures, and does it feel that they will further increase the safety margin and that they can be regarded as a significant contribution to public health?

3. Is the Commission taking account of these voluntary standards, as announced by manufacturers of plasma derivatives, in its current review of measures for selecting donors and for investigating donations?

4. Does the Commission feel there is a need for standards similar to those which have been introduced for plasma donations and plasma derivatives to be considered for blood donations and blood products intended for transfusion?

Answer given by Mr Bangemann on behalf of the Commission (15 October 1997)

The Commission has been aware of the steps taken on their own initiative by a number of manufacturers of human plasma derivatives concerning the draconian selection of blood donors in order to ensure that the latter are free of certain viral contaminants.

Measures such as the detection, using genome amplification techniques, of viral antigens carried out on batches of plasma derivatives, the decision not to use blood donated by one-off donors but to give preference to that of regular donors and storing donors' blood during the theoretical seroconversion period of at least 60 days are, of course, likely to reduce the risks of contamination by pathogenic agents and are thus contributing to the supply of plasma derivatives offering a high degree of safety for health.

Current thinking with a view to establishing the most appropriate criteria to be adopted at Community level regarding the selection of donors, namely their suitability according to the use to which their blood will be put later (transfusion or fractionation) and regarding the investigation of blood donations is setting great store by the information acquired from the most rigorous experiments recently carried out in this field. Since such donations comprise both whole plasma and plasma derivatives for transfusion purposes, in order to attain the greatest possible safety level for transfusion purposes, they must fulfil stringent specific requirements, notably that of the use or not of genome amplification techniques, regarding which approval is not yet unanimous.