Recommendation 1998/463 - 98/463/EC: Council Recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the EC - Main contents

official title

 

Legal instrument	Recommendation
Number legal act	Recommendation 1998/463
Original proposal	COM(1997)605
CELEX number i	31998H0463

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98/463/EC: Council Recommendation of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community

Official Journal L 203 , 21/07/1998 P. 0014 - 0026

COUNCIL RECOMMENDATION of 29 June 1998 on the suitability of blood and plasma donors and the screening of donated blood in the European Community (98/463/EC)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 129(4), second indent,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Parliament (1),

• (1) 

  Whereas in accordance with Article 3(o) of the Treaty, Community activity is to include a contribution towards the attainment of a high level of health protection;

• (2) 

  Whereas the Commission's Communication of 21 December 1994 on Blood Safety and Self-sufficiency in the European Community identified the need for a blood strategy in order to reinforce confidence in the safety of the blood transfusion chain and promote Community self-sufficiency;

• (3) 

  Whereas, in response to the Commission's Communication, the Council adopted, on 2 June 1995, a Resolution on blood safety and self-sufficiency in the Community (2);

• (4) 

  Whereas the Council adopted, on 12 November 1996, a Resolution on a strategy towards blood safety and self-sufficiency in the European Community (3);

• (5) 

  Whereas the European Parliament in its Resolutions on blood safety and self-sufficiency in the European Community (4) (5) (6) (7) has stressed the importance of ensuring the highest level of safety in the selection of donors and the testing of donations and the principle of voluntary unpaid donations and has reiterated its continued support for the objective of Community self-sufficiency;

• (6) 

  Whereas Directive 89/381/EEC (8) extended the scope of pharmaceutical legislation to guarantee the quality, safety, and efficacy of proprietary industrially prepared medicinal products derived from human blood or human plasma; whereas that Directive as such does not apply to whole blood, to plasma, or to blood cells of human origin;

• (7) 

  Whereas therapeutic use of blood and medicinal products derived from human blood and plasma contributes significantly to saving lives and yields considerable benefits for those suffering from long term blood disorders; whereas, however, in spite of their significant therapeutic value, blood, blood components, and blood and plasma derivatives have the potential to transmit infectious diseases;

• (8) 

  Whereas the availability of blood and plasma used for therapeutic purposes and as starting material for the manufacture of medicinal products is dependent on the willingness and generosity of Community citizens who are prepared to donate;

• (9) 

  Whereas donations should be voluntary and unpaid;

• (10) 

  Whereas in respect of blood or plasma as a starting material for the manufacture of medicinal products, Article 3 of Directive 89/381/EEC refers to measures covered by the amendments to testing requirements, referred to in Article 6 of that Directive, to be taken by Member States to prevent the transmission of infectious diseases, including the application of the monographs of the European Pharmacopoeia and the measures recommended by the Council of Europe and the World Health Organisation (WHO) particularly with reference to the selection and testing of blood and plasma donors; to promote Community self-sufficiency in human blood or human plasma; and to encourage voluntary unpaid donations of blood and plasma;

• (11) 

  Whereas it is not always possible to know at the time of whole blood or plasma collection which donation may be used for further manufacture rather than used in transfusion;

• (12) 

  Whereas all...

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