Select Committee on European Scrutiny Twelfth Report


COM(00) 816

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 89/381/EEC.

Legal base:Article 152(4)(a) EC; co-decision; qualified majority voting
Basis of consideration: Minister's letter of 17 December 2001
Previous Committee Report: HC 28-viii (2000-01), paragraph 11 (14 March 2001), HC 152-iv (2001-02), paragraph 5 (7 November 2001) and HC 152-vi (2001-02), paragraph 6 (14 November 2001)
Discussed in Council: 15 November 2001
Committee's assessment:Politically important
Committee's decision:Cleared (decision reported on 14 November 2001)


  13.1  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 set out in the current document the ways in which this might be achieved. Together with the Government's reactions, these were described at greater length in our predecessors' Report of 14 March 2000, when they decided to defer any decision until the Government had provided some kind of Regulatory Impact Assessment.

  13.2  In a Supplementary Explanatory Memorandum of 24 October 2001, the Parliamentary Under-Secretary of State at the Department of Health (Ms Hazel Blears) said that some of the amendments proposed by the European Parliament at its first reading of the proposal on 2 October 2001 would, if adopted, have important implications for the proposal, notably the requirements that all donations of blood (including imports) would have to be voluntary and unpaid; that all the detailed annexes to the proposal would be deleted; and that a competent person within the terms of the proposal would need to hold a medical qualification, preferably with a specialisation in haematology or a related medical specialisation, and that any medical examination prior to donation would have to be carried out by a doctor rather than a nurse.

  13.3  The Minister also attached to her Supplementary Explanatory Memorandum a Regulatory Impact Assessment. This indicated that the principal benefit from the proposal would stem from guaranteeing minimum standards across the Community, but that the main costs would arise from the inspection requirements placed upon the Medicines Control Agency (MCA), and — assuming the proposal applied also to hospital blood banks — Clinical Accreditation Pathology UK (CPA).

  13.4  In our Report of 7 November 2001, we asked for further clarification (i) on the likelihood of the United Kingdom being able to ensure that supplies from third countries would not be jeopardised by any insistence on their being from unpaid donors; (ii) on whether the proposal would apply to hospital blood banks; and (iii) on the extent to which the conditions regarding the medical qualifications needed would be amended to meet the concerns which the Minister had expressed. We added that it would also be helpful if she could say a little more about the proposal to delete all the detailed annexes in the original proposal. Whilst we could see that the latter might well have been over-prescriptive, total deletion appeared to risk going to the opposite extreme, and leaving the measure couched in terms too general to be effective.

  13.5  These matters were dealt with in a latter of 12 November 2001 from the Minister of State for Health at the Department of Health (Mr John Hutton) in terms which are set out in paragraphs 6.8 and 6.9 of our Report of 14 November 2001. In the light of this explanation, we said that we recognised that, overall, the UK was in favour of this proposal, in view of the benefits it would bring, not least for those UK citizens who may need to have access to blood when in another Member State. We therefore cleared the document, but said that, if a decision was taken at the Health Council scheduled for 15 November 2001, we would like the Minister to write to us again afterwards to inform us of the outcome.

    Minister's letter of 17 December 2001

  13.6  In his letter of 17 December 2001, the Minister said that the compromise wording agreed at the Council on 15 November 2001 had not yet been ratified by Jurists-Linguists or officially published, and that the European Parliament was due to begin its second reading in January 2002. Nevertheless, the Government believed that it had achieved at that Council its main aim of ensuring that, whilst it supports the principle of voluntary unpaid donations, no binding commitment was placed on Member States to obtain blood only from such sources, thereby enabling the UK to retain the right to import raw plasma from pooled products from the United States as a means of reducing the risk of vCJD.

  13.7  On the other outstanding points, he said that, as regards hospital blood banks, the UK has promoted a solution which leaves Member States to determine the mechanism for ensuring quality and safety standards, thereby avoiding mandatory inspections every two years, which it had regarded as increasing costs without improving standards; that the definition of the medical qualifications required for "responsible persons" had been loosened to make them more proportionate to the nature of the job; and that, as regards the technical annexes, the measure would now respect the aims of the Directive, but prevent the Commission from extending its powers without formal request.


  13.8  We are grateful for the Minister for this further information, though we note the absence of an official text of the latest version and the fact that the European Parliament is to begin its second reading around now. We assume that, if the Parliament does come forward with any amendments, these will be the subject of a further Commission proposal, but, in any event, we would be grateful if the Minister could keep us informed of any significant developments.

previous page contents next page

House of Commons home page Parliament home page House of Lords home page search page enquiries index

© Parliamentary copyright 2002
Prepared 25 January 2002