B4-1053, 1054, 1056, 1058, 1060, 1061 and 1066/95

Resolution on blood safety in the European Union

The European Parliament,

- having regard to Council Directive 89/381/EEC ((OJ L 181, 28.6.1989, p. 44.)) of 14 June 1989 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood or human plasma, which are the only products to which this Directive applies,

- having regard to its resolution of 14 September 1993 on self-sufficiency in and safety of blood and its derivatives in the European Community ((OJ C 268, 4.10.1993, p. 29.)),

- having regard to its resolution of 18 November 1993 on safe blood transfusions and use of blood derivatives ((OJ C 329, 6.12.1993, p. 268.)), adopted after a debate on infected blood,

- having regard to the conclusions of the Council of 13 December 1993 on self- sufficiency in blood in the European Community,

- having regard to the communication from the Commission on blood safety in the European Community (COM(94)0652),

- having regard to the conclusions of the Council of 2 June 1995 on blood safety and self-sufficiency in the European Community,

- having regard to the answers by the Commission to the questions asked,

A. disturbed at reports to the effect that there is an expanding black market in blood products in various Member States,

B. whereas it is vital to ensure maximum transparency as regards information on health matters, and whereas the Commission should give full support to Member States' governments in carrying out a survey and taking all the necessary measures to ensure maximum safety in health terms across the whole circuit of monitoring the collection and use of blood and plasma,

C. whereas the European Union's blood product requirements are inadequately catered for,

D. whereas fears of diseases being transmitted through blood transfusion or the use of blood derivatives have recently increased considerably,

E. having regard to the principle that the human body and its constituent parts are inviolable and must not be the source of profit or the subject of trading,

F. having regard to the need to promote and safeguard voluntary blood donor organizations and recognize their role as an expression of solidarity,

G. whereas Article 129 of the EC Treaty establishes a Community competence for health protection,

1. Considers that it is essential that blood and plasma should move freely within the Union in the interests of self-sufficiency, provided blood and plasma donation is suitably regulated;

2. Reiterates that the objective of Community self-sufficiency in blood and blood derivatives must be achieved while adhering to the principle of voluntary, unremunerated and anonymous blood donations; considers, therefore, that blood donations should be promoted in the Member States with Community support and that the quality and safety of blood donations and the optimal use of blood and blood derivatives must be guaranteed;

3. Considers that, inter alia on the basis of the above-mentioned Directive 89/381/EEC, the principle of blood self-sufficiency in the Union should be confirmed in order to prevent imports from third countries and the commercial exploitation of blood and to guarantee stability of supplies and costs;

4. Affirms that the establishment of a detailed, strict and harmonized legal framework is a prerequisite to achieving the objective of European self- sufficiency in blood products;

5. Affirms that any political decision on blood products and self-sufficiency must give priority to ensuring the safety of blood and blood derivatives and an adequate supply of blood products to meet the needs of European patients;

6. Considers that the Community institutions should draw up joint legislation for the transfusion chain covering the procedures for selecting donors, the testing of donated blood using rules for the approval of basic diagnostic instruments and quality controls and procedures to guarantee quality and good manufacturing practice as regards medicinal products made from blood and plasma;

7. Calls on the Commission to ensure that quality criteria are laid down and sound practices are developed for the collection, treatment and transfusion of blood and blood products;

8. Proposes that the Union launch an ambitious programme to harmonize procedures for managing stocks, administering blood products to patients and setting up a follow-up system for recipients of blood transfusions;

9. Welcomes the submission of a communication by the Commission on blood safety and self-sufficiency in the EU;

10. Considers it necessary to regulate the working methods of blood banks and determine the criteria for full blood donation;

11. Calls for regulation of plasma collection through plasmapheresis centres in order to ensure the quality and safety which can be achieved by apheresis in the interests of achieving self-sufficiency in Europe;

12. Calls for the establishment, for particular groups, of blood and plasma donation programmes in the Member States, on the basis of specific criteria for selecting individual donors of blood or plasma;

13. Calls on the Commission to present a proposal in the near future with a view to establishing a system to make blood 'traceable', whereby blood could be traced right back to the donor, while guaranteeing the essential preservation of anonymity;

14. Considers that the method of plasmapheresis should be promoted in the European Union in view of the quality and safety guarantees offered by this method and in view of its contribution to European self-sufficiency;

15. Recommends that a Community-wide blood monitoring system be introduced in order to gather epidemiological data relating to the blood transfusion chain on the basis of existing networks;

16. Reasserts its view that the task of coordination and monitoring medicinal products throughout the entire chain of blood derivatives should be given to the European Agency for the Evaluation of Medicinal Products;

17. Considers that cooperation between the judicial authorities and the police should be promoted without delay in order to put a stop to illicit trading in plasma and products derived from it;

18. Calls on the Commission to examine, as a matter of urgency, what action could be taken to achieve these objectives;

19. Reasserts that it is essential for existing legislation to be enforced rigorously and for persons suspected of illegal actions and transactions to be brought to trial;

20. Urges the Member States to provide adequate compensation for victims of contaminated transfusions and their families;

21. Repeats its call for an information campaign which, in connection with the safety of blood transfusions and the use of blood derivatives, is directed at recipients, and promotes adequate information on the possibility of autotransfusion, so as to avoid any outbreak of panic or abuse of the situation;

22. Reiterates the importance of giving medical students, practising doctors and the staff of transfusion centres and health care establishments comprehensive training and regular refresher courses in order to update their knowledge of safe transfusion procedures;

23. Instructs its President to forward this resolution to the Commission, the Council and the competent bodies of the Member States.