COUNCIL RESOLUTION of 2 June 1995 on blood safety and self-sufficiency in the Community (95/C 164/01)

THE COUNCIL OF THE EUROPEAN UNION,

RECALLING the Commission communication of 25 May 1993 on blood self-sufficiency in the European Community and its conclusions of 13 December 1993 on that communication;

NOTES with interest the Commission communication of 21 December 1994 on blood safety and self-sufficiency in the European Community;

REAFFIRMS the need to achieve self-sufficiency in blood (and its derivatives in the Member States) and in the Community, in particular through cooperation between Member States, in accordance with the principle of voluntary, unpaid blood donations;

EMPHASIZES that the efforts to promote the quality and safety of blood collection help to prevent AIDS and other communicable diseases;

RECALLS that Directive 89/381/EWG (1) which extends the scope of Directives 65/65/EEC and 75/319/EEC on proprietary medicinal products by laying down special provisions regarding medicines derived from human blood or plasma applies only to these products;

AGREES on the need to define a strategy for reinforcing trust in the safety of the blood-transfusion chain and promoting self-sufficiency in the Community;

ACCORDINGLY AGREES that, taking full account of the Council of Europe's discussions, the main activities to be undertaken could include:

- the development of policies and agreed procedures in the donor-selection process among blood-collection establishments,

- the implementation of efficient, validated and reliable screening tests,

- the development and use of quality-assessment criteria and good practices regarding the collection, processing and transfusion of blood and blood products and patient follow-up procedures,

- development of a haemovigilance system on the basis of existing networks for the collection of epidemiological data related to the blood-transfusion chain,

- encouragement of health professionals to make optimal use of blood and blood products,

- the establishment of basic criteria for inspection and training of inspectors,

- the dissemination to the public of information on blood and blood products and on collection, processing and transfusion procedures, taking into account socio-cultural differences;

INVITES THE COMMISSION:

- to continue its collaboration with the Member States in the search to define a strategy for reinforcing trust in the safety of the blood-transfusion chain and for promoting self-sufficiency in the Community through voluntary unpaid donations and to send it regular progress reports,

- to continue its cooperation with the Council of Europe in the blood transfusion area,

- to submit appropriate proposals in the specific areas mentioned in support of Member States' action and to encourage the development of a coordinated approach in the matter of blood safety.

(1) OJ No L 181, 28. 6. 1989, p. 44.