Select Committee on European Scrutiny Thirty-Fourth Report



Draft Council Directive setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components, and amending Council Directive 2001/83/EEC.

Legal base:Article 152(4)(a) EC; co-decision; qualified majority voting
Basis of consideration:EM of 20 June 2002
Previous Committee Report:None, but see footnote below
To be discussed in Council:26 June 2002
Committee's assessment:Legally and politically important
Committee's decision:Cleared


  12.1  Although the Community has enacted a number of legislative measures applicable to blood and medicinal products derived from it, the Commission has taken the view that these do not address comprehensively the necessary quality, safety and efficacy requirements. It therefore put forward in December 2000 a draft Directive[15] which would set out the ways in which this aim might be achieved. Together with the Government's reactions, these were described at greater length in our predecessors' Report of 14 March 2001, and we ourselves subsequently reported on the changes made to the proposal following discussions in the Council and the European Parliament's first reading on 2 October 2000. In particular, we noted in our Report of 16 January 2002 that, although the compromise wording agreed at the Health Council on 15 November 2001 had not yet been ratified by Jurists-Linguists or officially published, and the European Parliament had still to begin its second reading, the Government believed that it had achieved a satisfactory outcome on the points which had given most concern. These were that supplies from third countries should not be jeopardised by any insistence on their being from unpaid donors; the application of the proposal to hospital blood banks; and the extent to which the conditions regarding the medical qualifications needed might prove to be unduly onerous.

The current document

  12.2  Although we have yet to see any official text, we have received an Explanatory Memorandum of 20 June 2002 from the Parliamentary Under Secretary of State at the Department of Health (Ms Hazel Blears), drawing our attention to the eight amendments which the European Parliament proposed at its second reading on 12 June to the Council's Common Position. Although the Minister says that the UK could accept six of these, she considers that the remaining two could potentially cause considerable problems.

  12.3  She says that, although somewhat ambiguously worded, the first appears to suggest that a doctor should be present at the medical examination (including an interview and blood pressure check) which would be required before any blood is donated. According to the Minister, this would create major problems for the UK Blood Services, to the point of being unenforceable. She points out that nurses are trained to conduct these donor sessions, and the UK does not think it necessary to use doctors (and indeed does not have enough available to do so); that blood pressure checks are not carried out on donors in the UK, unless there is a history of high or low pressure; and that a requirement to carry out such checks would represent a further, but unnecessary, step in the donation process. The Minister also points out that the Commission proposal is based on Article 152(4)(a) of the Treaty, which ensures a high standard of quality and safety of blood, whereas the health of the donor is outside the scope of this Article, and that the proposed amendment also contravenes Article 152(5), which leaves national provisions on blood donation to Member States. In view of these concerns, she says that the Government feels it is justified in rejecting the amendment, and that, if necessary, it will be seeking support in the Council to push the proposal into conciliation.

  12.4  The Government's other concern relates to an amendment requiring blood products to be tested in conformity with the latest scientific and technical procedures. The Minister says that, although the amendment does not in itself appear unreasonable, it does not make clear the extent of the scientific certainty needed, or how much weight should be put on cost-benefit analysis. She adds that, since the European Court of Justice has a tendency to put less weight on such considerations than UK courts, it could decide to consider solely arguments relating to public health, and thus place Member States in a vulnerable position. Consequently, here too, the Government feels it would be justified in resisting the amendment to the point of pushing the Directive into conciliation in order to clarify this point.

  12.5  The Minister says that the Spanish Presidency is seeking to reach political agreement at the Health Council on 26 June, but that this is looking increasingly unlikely, as it is dependent on the Council accepting the European Parliament's amendments.


  12.6  We are grateful to the Minister for this further information, and we have noted the Government's strong reservations about two of the eight amendments put forward by the European Parliament at its second reading. We share the Minister's concerns on the question of the Treaty base. Although we do not think any useful purpose would be served at this late stage in seeking to put in place a scrutiny reserve, we nevertheless think that these two points are of sufficient importance to be drawn to the attention of the House, and we would be glad if the Government could continue to keep us informed of any significant developments.

15   (22122) 5773/01; HC 28-viii (2000-01), paragraph 11 (14 March 2001), HC 152-iv (2001-02), paragraph 5 (7 November 2001), HC 152-vi (2001-02), paragraph 6 (14 November 2001) and HC 152-xii (2001-02), paragraph 13 (16 January 2002). Back

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Prepared 11 July 2002