A4-0094/96

Resolution on the communication from the Commission on blood safety and self- sufficiency in the European Community

The European Parliament,

- having regard to Council Directive 89/381/EEC of 14 June 1989 ((OJ L 181, 28.6.1989, p. 44.)), which extended the scope of Directives 65/65/EEC and 75/319/EEC on approximation of provisions laid down by law, regulation and administrative action relating to proprietary medicinal products and laying down special provisions for medicinal products derived from human blood and plasma,

- 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 transfusion and use of blood derivatives ((OJ C 329, 6.12.1993, p. 268.)),

- having regard to the conclusions of the Council of 13 December 1993 on Community self-sufficiency in blood ((OJ C 15, 18.1.1994, p. 6.)),

- having regard to the resolution of the Health Ministers Council of 2 June 1995 on safety and self-sufficiency with regard to blood transfusions,

- having regard to the Commission communication on blood safety and self-sufficiency in the European Community (COM(94)0652 - C4-0016/95),

- having regard to the various recommendations of the Committee of Ministers to the member states of the Council of Europe, for example the recent Recommendation No R (95) 14 of 12 October 1995,

- having regard to its resolution of 14 July 1995 on blood safety in the European Union ((OJ C 249, 25.9.1995, p. 231.)),

- having regard to the report of the Committee on the Environment, Public Health and Consumer Protection and the opinion of the Committee on Legal Affairs and Citizens' Rights (A4-0094/96),

A. whereas a number of known and possibly also unknown viruses can be transmitted via cell components and via plasma, including the human immunodeficiency and hepatitis viruses and the parvovirus B19 which can be transmitted by both,

B. whereas an infection caused by these different viruses may cause serious illness such as severe immunodeficiency due to HIV or cirrhosis or cancer due to hepatitis,

C. whereas blood and plasma may be contaminated at the time of donation by non-viral organisms such as spirochetes, parasites and bacteria, resulting in serious infection,

D. whereas the use of blood and blood products must therefore be considered from the perspective of whole blood and its cellular components, on the one hand, and that of plasma and medicinal products derived from plasma on the other,

E. whereas by ensuring that the risks associated with each link in the blood collection, testing and transfusion chain are minimized overall safety of the chain can be achieved,

F. whereas the risk of contracting a disease as a result of the transmission of infectious agents in blood, plasma and their derivatives varies depending on their prevalence in the population, the state of health of the donor who may have a natural immunity to certain viruses, the immunity of recipients who may have antibodies, and the quantity of the infectious agent in the donated blood, plasma or cells,

G. whereas in order to ensure the highest level of blood and blood products safety, three key elements need to be addressed: the selection of donors, the testing of donations and the removal or inactivation of infectious agents,

H. whereas quality and safety guarantees are offered by procuring plasma through apheresis,

I. whereas efforts to reduce the risk of virus transmission from blood derivatives are extensive and continuing,

J. whereas the principles of unpaid, voluntary, anonymous donation recommended by the World Health Organization must be regarded as inviolable fundamental principles governing the donation of any substance of human origin, such as blood or organs,

K. whereas the European Union has set itself the goal of achieving self- sufficiency in blood and blood products on the basis of voluntary, unpaid donations,

1. Notes the European goal of self-sufficiency and calls on the Commission and the Member States to abolish laws and administrative provisions which prevent the free circulation of plasma-derived products in the European Union;

2. Calls on the Commission to take the necessary measures to guarantee maximum safety in supplies and use of blood and its derivatives and to encourage blood self-sufficiency in the Community by means of voluntary, unpaid donation, in accordance with the undertaking in its statement made at the meeting of 19 December 1995 of the Council-Parliament conciliation committee on the AIDS prevention programme; in particular, common requirements for labile blood components should be established across the European Union;

3. Calls on the Commission to urge the Member States to take the appropriate action to achieve the objective of self-sufficiency on the basis of voluntary, unpaid donations;

4. Calls for increased support for voluntary blood donor associations and organizations and the holding of a European blood donation day;

5. Calls for common regulations, based on reliable scientific data, to be drawn up applicable to the whole of the blood transfusion chain concerning:

(a) the selection of donors, based on:

- devising questionnaires identifying factors linked to a possible transmission of disease or endangering the health of the donor (medication being taken, presence of diseases, recent surgery or childbirth, visits to endemic areas, recent vaccinations, dangerous sexual practices or drug addiction); naturally, the absolute confidentiality of data must be guaranteed and the requirement of professional secrecy on the part of those who handle such data for administrative purposes must be specified;

- examination of key physical parameters, such as blood pressure and haemoglobin levels,

- the psychological preparation of donors: voluntary giving, motivation and awareness of the dangers of transmitting disease via blood;

- a comparison with the blood parameters of the previous donation;

(b) devising uniform tests of the highest technological level throughout the European Union for screening for viral infections transmissible via blood (such as PCR testing of human plasma and plasma products) and identifying bacteria and parasites. Blood or plasma infected with viruses or bacteria or about which any doubt whatever exists should be destroyed immediately and the donor, in the strictest confidence, persuaded to seek treatment or, at the least, undergo examination, and told not to donate any more blood until he or she is fully recovered;

(c) the way in which blood, plasma or blood derivatives are treated within the transfusion chain, i.e. storage and handling conditions and the application of the strictest standards of hygiene in legally recognized centres and laboratories;

(d) the rational use of blood, plasma and blood-derivatives on the basis of patient and physician need for safe and suitable quantities determined at the point of treatment, taking account not only of the shortage of plasma particularly, but also of underlying risks. The use of self- transfusion should be promoted whenever possible and maximum publicity should therefore be given to this via suitable information media;

6. Calls for the method of plasmapheresis to be promoted throughout the European Community in view of its advantages in terms of quality and safety of plasma used for fractionation;

7. Reaffirms the fundamental principle of the inalienability and non-marketability of the human body and of any organs or substances obtained from it, and the need to select voluntary, unpaid donors;

8. Stresses the need for appropriate training for health professionals, with transfusion being included in university medical courses and in training programmes for all health professionals involved in the blood transfusion chain;

9. Calls on the Commission to support research activity on effective, validated and reliable blood and blood products screening tests in the Community and to standardize, on the basis of these scientific data, the infectious markers detected;

10. Calls on the Commission to launch and/or support action of all kinds which seeks to encourage the dissemination of information about blood and blood products and collection, treatment and transfusion procedures, through promotional material, films and publicity campaigns designed to restore blood transfusion's positive image; calls on the Commission to provide for the dissemination of such information in all educational establishments in order to make citizens aware of the problem;

11. Calls on the Commission and the Member States to recognize the significant safety benefits arising from blood and plasma donors who donate repeatedly, and to encourage new and existing donors to donate;

12. Calls on the Commission and the Council to work towards the setting up of a European Blood Safety Supervisory Body responsible for monitoring blood and blood derivatives from the time of collection and conservation to the time of use;

13. Calls on the Commission and the Council to look into the possibility of harmonizing the granting of licences to organizations involved in the collection, treatment, processing and distribution of blood and blood derivatives in the European Union;

14. Instructs its President to forward this resolution to the Commission and Council and to the governments and parliaments of the Member States.