B3-1577, 1593, 1601, 1622, 1630 and 1637/93

Resolution on safe blood transfusions and use of blood derivatives

The European Parliament,

A.alarmed that blood derivatives obtained from plasma not subjected to the controls laid down in Directive 89/381/EEC and therefore extremely dangerous for consumers are circulating in various Community countries,

B.whereas such preparations can transmit viruses such as the AIDS and hepatitis C viruses, causing the death of innocent citizens and infecting many others,

C.whereas, according to the data available, more than 1000 people in the European Community have died after receiving the AIDS virus from transfusions or blood derivatives, while it is impossible to calculate the number who have died from hepatitis out of all those infected,

D.whereas blood derivatives should be allowed to move freely as medicinal products; whereas, however, because of their specific nature, they require additional safety rules, which is why Directive 89/381/EEC was adopted,

E.whereas most of the Member States have not yet implemented the directive despite the numerous resolutions adopted by Parliament, in particular its resolution of 14 September 1993 on self-sufficiency in and safety of blood and its derivatives in the European Community,

F.whereas in the first place Directive 89/381/EEC must be implemented by all the Member States; whereas the goal of European self-sufficiency in blood products from unpaid donors must be pursued and achieved as soon as possible,

G.whereas, however, recent revelations not only in Germany but also in other countries show that the magnitude of the problem raised by the scourge sweeping the planet cannot be reduced to mere questions of non-payment for blood collected, precise knowledge of its origin and the confidence about its quality which individual screening brings,

H.whereas the health and prophylactic measures to be taken no longer concern only HIV in its various forms but also the action of non-conventional transmissible agents - about which little or nothing is yet known - revealed by the spread and development of various serious diseases associated in particular with blood transfusions or the administration of blood derivatives,

1.Calls as a matter of urgency for the immediate suspension throughout the Community of marketing authorizations for products already suspended in some Member States and for all others for which there is no documentation of the negativity of the controls laid down by Directive 89/381/EEC;

2.Calls as a matter of urgency for a health inspection at the various production stages in all the industries and all other transfusion organizations, whatever their legal status, that produce or import plasma and blood derivatives to certify that controls are carried out on the raw material at the outset and throughout the production chain, failing which authorization for the production and import of plasma and plasma products should be withdrawn;

3.Calls as a matter of urgency for an emergency Community protocol authorizing the use of all safe products available on Community territory to prevent black market phenomena and any lack of life-saving products;

4.Calls on the Member States as a matter of urgency to provide data on the dosages given to multi-transfusion cases, with a view to setting up a transfusion epidemiological monitoring unit;

5.Calls for a consumer information campaign to be entrusted to scientific authorities independent of the industry on the safety of transfusions and the use of blood derivatives in order to prevent waves of panic and exploitation;

6.Calls for a proposal to be drawn up pursuant to Articles 100, 129 and 129a of the EC Treaty amending Directive 89/381/EEC and guaranteeing monitoring of the safety of blood at all stages, from donation to perfusion, of the transfusion chain throughout the Community;

7.Calls for the European Medicinal Products Agency to be made responsible for coordination and pharmacological monitoring in respect of the entire blood product chain;

8.Calls for rigorous application of the law and for all guilty parties to be brought to trial;

9.Calls on the Member States to do everything in their power to enable persons who have had transfusions to receive adequate information and to undergo the requisite screening tests, and for persons contaminated following transfusion to be treated free of charge and to receive compensation;

10.Calls on the Member States to take appropriate action to guarantee that patients who need 'blood products that have not undergone virus-inactivation e.g. whole blood, blood cells and plasma', receive them as soon as possible from voluntary and unpaid donations;

11.Stresses once again that blood donated free of charge should not be processed commercially and that imports should only be allowed if the blood was donated free;

12.Calls for a wide-ranging debate on all these issues, preceded by expert opinions drawn up by international and national institutions and scientists working throughout the world to halt the current epidemic and to eradicate the various forms of the disease, this being a necessary stage in the definition of a policy at Community level;

13.Calls on the Council to take practical steps in this direction at its meeting on 13 December 1993;

14.Calls for the setting up of a European blood safety authority covering all countries that adopt the Council of Europe protocols, and for it to include Members of the European Parliament;

15.Instructs its President to forward this resolution to the Commission, the Council and the appropriate authorities in the Member States.