Blood safety and self-sufficiency in the European Community
1994/2228(COS)
In this document, the Commission reviews both the tremendous benefits from the therapeutic use of blood products and hence the fact that they are indispensable to medicine nowadays, and the huge dangers inherent in blood transfusions in the Community. In this respect, it expresses a number of thoughts on how to improve the safety of transfusions and proposes a series of Community measures in order to reduce the risk of transmission of serious diseases such as AIDS, hepatitis A, B and C, syphilis, borreliosis, malaria and septicaemia.
In order to achieve this, the Commission calls first for greater awareness of the dangers of transfusion by increasing the public's awareness of the use of blood and plasma, the precautions needed in order to maximise safety and the measures needed in order to achieve self-sufficiency in blood.
It calls on the Member States to apply strict selection criteria for blood donors and, within the framework of the free movement of blood in the Community, to harmonise donor selection procedures in force in the Member States in order to give a greater guarantee of the safety of blood products of Community origin. Along the same lines, the Commission raises the possibility of harmonising the systems of tests carried out on donated blood and plasma. The Commission would also like studies to be carried out on the use of blood products from the point of view of the patient (especially within the framework of medicinal products derived from human plasma), the donor, self-sufficiency (while guaranteeing optimum use of blood and plasma), good clinical practice and the financial implications. The Commission also refers to the need to introduce a blood surveillance system based on a network of European transfusion centres linked to epidemiological agencies in order to determine the level of risk (and eventually eliminate the risk) inherent in transfusions of infectious blood agents.
Next steps: because blood and blood products move within the Community, a Community blood strategy needs to be defined in order to:
- draw up scientifically reliable policies and common donor selection procedures in the Community;
- use efficient, valid, reliable screening tests throughout Europe;
- draw up quality evaluation criteria and good manufacturing practices for collecting and giving transfusions of blood and monitoring patients;
- introduce a blood monitoring system in order to compile epidemiological data on the transfusion sector;
- draw up educational programmes for health professionals on the optimum use of blood;
- encourage the dissemination of information on blood and on blood collection, processing and transfusion procedures through awareness-raising programmes.�