A3-0075/93

Resolution on self-sufficiency in and safety of blood and its derivatives in the European Community

The European Parliament,

-having regard to Directive 89/381/EEC of 14 June 1989 on medicinal products derived from human blood or human plasma,

-having regard to the motion for a resolution by Mr Martin on payment of compensation to non-haemophiliacs who have been infected with HIV (B3-1053/91),

-having regard to the motion for a resolution by Mrs Mayer on promotion of voluntary blood donations without payment within the Community (B3-1528/92),

-having regard to the report of the Committee on the Environment, Public Health and Consumer Protection (A3-0075/93),

A.whereas blood transfusion is used to treat a number of disorders and can have a considerable beneficial effect on health in both emergency situations and cases of chronic disease,

B.whereas the Community's principal duty is to ensure that all its citizens can avail themselves of transfusion therapy by ensuring that the demand for blood and its derivatives is fully met, e.g. by means of exchange arrangements between the various Member States,

C.whereas the significant results achieved with transfusion therapy have been made possible by the readiness to give blood voluntarily and free of charge in a spirit of solidarity, particularly the solidarity of those working in voluntary donor organizations, and by technological innovation in the industry,

D.whereas the Member States must do their utmost to become self-sufficient in blood and blood products from voluntary and unpaid donations,

E.whereas developments in transfusion therapy have made it necessary to use paid blood or plasma donors to ensure self-sufficiency,

F.whereas the sale of blood contradicts the principle that the human body is inviolable and there may be no trade in any of its parts,

G.whereas the European Community as a whole is not self-sufficient in blood and blood products,

H.whereas according to the Council of Europe report "Plasma products and European self-sufficiency" (the Van Aken report) self-sufficiency for plasma products derived from blood of unpaid donors is an attainable goal if measures are implemented towards: the rational use of plasma derivatives; an increase in the number of donors/donations of whole blood or plasma (via plasmapheresis) and the improvement of the yield of certain products,

I.whereas Directive 89/381/EEC has not yet been transposed into the legislation of the majority of Member States, whereas this delay has an adverse effect on the health of consumers who continue to use products which do not bear any indication of their source, and whereas their compliance with Community standards has not as of 31 December 1992 been assessed in all cases; whereas this directive needs to be properly enforced,

J.whereas it is extremely important that the abovementioned directive be fully implemented in all the Member States to ensure the quality, safety and efficacy of medicines derived from human plasma available in the EC; whereas, however, strategies must be implemented to achieve the goal of self-sufficiency,

K.whereas according to the Council of Europe report on 'Plasma products and European self-sufficiency' (the Van Aken report) not all Member States are at present able to guarantee that all their blood is being collected under the highest possible conditions of safety and under the best possible supervision with the result that although blood transfusion in the Community today is much safer than it was some years ago it is not completely shielded from avoidable risks,

L.whereas according to the Council of Europe report "Plasma products and European self-sufficiency" (the Van Aken report) quality guarantees for blood collection in all member countries should be harmonized to guarantee the best quality plasma and the safest source material,

M.whereas each Member State must, having due regard for data protection legislation, compile a national blood donation register which, when forwarded to the authorities, will provide them with information on both the place of origin and the address of the recipient so that the source of any contamination can be traced at any time in the interests of both the donor's and the recipient's health,

N.whereas the free movement of industrially produced blood derivatives must be safeguarded by defining uniform standards on quality, safety and efficacy,

O.whereas the biological risk following a blood transfusion should be given uniform recognition throughout the Community and whereas the Member States must make compensation available under appropriate legislation,

P.whereas the text of Article 129 of the EC Treaty as laid down in the Maastricht Treaty opens the door to the enactment of legislation on the transfusion of blood, plasma and their derivatives not only with reference to the internal market but also to a higher level of public health,

Q.whereas it is a matter of priority to have available the requisite medicines in order to safeguard the right to health, while upholding the freedom of doctors to prescribe the appropriate treatment for each patient,

1.Declares that the principle whereby the human body and its parts are inviolable and may not be used for trading purposes must command the Community's allegiance and consequently:

(a)asks the Commission to inform Parliament of the progress made in implementing Directive 89/381/EEC with particular reference to the deadline of 31 December 1992 by which all products derived from blood ought to have been reassessed in the light of new standards of safety, quality and efficacy,

(b)asks the Commission to submit a proposal for amending Directive 89/381/EEC to take account of the objections raised by some Member States together with a follow-up communication governing blood donations, transfusions and blood banks, specifying that:

-products derived from blood must be obtained as quickly as possible only from plasma given by healthy volunteer donors, it being understood that the same safety standards apply to the private and public sectors regardless of the source of the plasma,

-the source and the means of collection must always be clearly indicated by the manufacturer,

-authorization of products from third countries shall be granted if they comply with the existing safety, efficacy and quality standards to guarantee free access to the marketplace and therefore free therapeutic choice of products to doctors and patients,

-the Community must retain its global responsibility, taking all the appropriate measures to ensure that third countries, and particularly Third World countries, receive products of satisfactory quality,

-blood from unpaid voluntary donations may not be processed purely for profit;

(c)calls for a gradual move away from the marketing of blood and blood products, as recommended by the Parliamentary Assembly of the Council of Europe, by accession to a code or international agreement advocating the principle of unpaid donations and laying down precise criteria to protect donors and recipients;

2.Asks the Council to take all appropriate measures to promote the Community's self-sufficiency by promoting national self-sufficiency in blood and its derivatives and to encourage voluntary and unpaid donations of blood and plasma;

3.Asks the Commission to draw up and the Council to approve an action plan on self-sufficiency in and safety of blood and its derivatives based on the following points:

(a)encouragement of voluntary donation for reasons of solidarity and transfusion safety; particular encouragement of plasma donations,

(b)assistance for Third World countries to help them achieve self-sufficiency,

(c)a European statute for donors and voluntary donor organizations defining their activities, rights, responsibilities and relations with public health departments and manufacturers,

(d)quality standards for the collection and processing of unstable products and the distribution of blood and its constituents,

(e)national registers compatible Community-wide and a Community register comprising full data on every unit collected and its subsequent use, and guarantees regarding their transparency and availability to all interested parties,

(f)promotion of clinical and therapeutic protocols for the use of blood including autotransfusion,

(g)support for pharmaceutical research to develop methods of treating blood which are safer and make optimum use of coagulation factors and other active substances, equally available to national programmes and to private industry,

(h)encouragement of biotechnological production methods, and the widest possible distribution of the products obtained thereby through such channels as transfusion centres and units,

(i)facilitating the exchange of blood and its derivatives between the Member States;

4.Asks the Council to recognize the biological risk which may derive from the use of blood and its stable and unstable products and accordingly request the Member States to enact legislation which will:

(a)apply to all those receiving transfusions,

(b)cover the risk from all viral agents which have been identified and can be diagnosed,

(c)shift the burden of proof on to those who manufacture the product responsible for the damage, by virtue of a proven fault, or those who authorize its use,

(d)where compensation is granted, will not remove the right to take legal action, if a criminal liability exists,

(e)take account of the fact that recognition of the risk must not prove an obstacle to health workers being able to exercise their profession with respect for medical ethics and professional standards;

5.Instructs its President to forward this resolution to the Commission and Council.