Brussels, 15/11/2001 (Agence Europe) - The Health Council managed, on Thursday in Brussels, to reach a political agreement with a view to a "common position" on amending the directive concerning security and quality norms for the collection, control, storage and distribution of blood. Austria, Germany and the United Kingdom, which expressed reservation on the general principle of free blood donations (see EUROPE of 12/13 November, p.12), were able to rally to the Presidency compromise which makes the initial text more flexible by making free donations not an obligation but an aim to be promoted by the Member States. The text of the agreement provides, in Article 19, for Member States to encourage voluntary free donations with a view to guaranteeing that, as far as possible, blood and blood components come from these donations.
The countries which, in a concern for safety, urged for stricter wording (Netherlands, France, Portugal, Luxembourg) agreed to make concessions so as not to hold up adoption of the directive, which, in their eyes, is important as it is founded on Article 152 of the Treaty for the first time. Nonetheless, several Member States added declarations to the minutes of the session to note their concerns. France (supported by Luxembourg, the Netherlands and Denmark) regrets that Article 19 is limited to simply encouraging Member States and stresses that the reference to good manufacturing practice should not apply to all blood products giving the impression that blood and blood components are products of the internal market like any others. The French authorities believe that they are, like anything else that comes from the human body, the "fruit of generosity and solidarity". In a second declaration, France stresses that the existence in Member States of stricter protection measures regarding the "persons responsible" is justified from the point of view of public health imperatives and cannot therefore be an obstacle to the free movement of workers. Portugal, for its part, specifies that, in its opinion, the voluntary and free gift of human blood and of blood components makes a decisive contribution to the quality and safety of blood products and that the lack of binding provisions could facilitate systematic recourse to the paid donation and thus compromise the aim of the directive which is to guarantee a high level of health protection.
The European Commission, for its part, pledged to make an additional declaration on two articles of the directive: Article 14 on traceability and Article 30 concerning the amendment of Directive 89/381 relating to pharmaceutical specialities and medicines derived from blood or human plasma.
The text of the agreement will now be consolidated to allow adoption, without debate, of a Council common position that will be forwarded to the European Parliament for second reading.