Select Committee on European Scrutiny Fourth Report


QUALITY AND SAFETY OF BLOOD


(22122)
5773/01
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
Department: Health
Basis of consideration: SEM of 24 October 2001
Previous Committee Report: HC 28-viii (2000-01), paragraph 11 (14 March 2001)
To be discussed in Council: 15 November 2001
Committee's assessment: Politically important
Committee's decision: Not cleared; further information requested

Background

5.1  Although the Community has enacted a number of legislative measures applicable to blood and medicinal products derived from it, the Commission says that these do not address comprehensively the quality, safety and efficacy requirements needed to cover the different destinations of blood[25] or plasma.[26] It therefore maintains that the Community needs to take action to meet these requirements, while respecting the responsibilities of the Member States for the organisation and delivery of health services and medical care. It has also pointed out that such a step would facilitate the movement of blood and blood products from one Member State to another, and remove restrictions on the movement of donors.

5.2  The ways in which it sees these aims being achieved are set out in the current document, which envisages:

    —  that there should be binding standards for the safety and quality of blood and blood components;

    —  that this should cover the information to be provided to, and obtained from, donors; the criteria for screening and deferring donors; testing requirements for whole blood and plasma donations; storage and freezing requirements; labelling requirements; and quality requirements;

    —  that a new committee of Member States' representatives should be established to update regularly these technical annexes, taking particular account of new and emerging communicable diseases;

    —  that a system to monitor adverse events associated with the collection, processing and use of blood and blood components in the Community should be established;

    —  that comparable national inspection and accreditation structures for "blood establishments" should be set up, with equivalent training for personnel involved throughout the blood transfusion chain; and

    —  that an information exchange system should be established between Member States to ensure safety and quality throughout the blood transfusion chain.

5.3  In addition, Member States would be required to lay down penalties for infringements of the national provisions adopted to implement the Directive. However, the Commission said that the Directive would not prevent Member States from maintaining or introducing more stringent protection measures in conformity with the Treaty, and would not affect national provisions on the donation or medical uses of blood.

5.4  In an Explanatory Memorandum of 26 February 2001, the then Parliamentary Under-Secretary of State at the Department of Health (Ms Gisela Stuart) said that the Government was "fully committed" to the Community strategy on ensuring the safety of the blood transfusion chain, and fully supported the development of a Directive setting high standards of quality and safety in this area. However, she also said that the proposal as it stood raised some concerns. In particular:

    —  it was extremely prescriptive, would be very difficult to translate into regulations, and carried the risk of being out of date as best practice and technology moved on;

    —  it contained "numerous inaccuracies", and included requirements which served no useful purpose, and which would increase costs without contributing to improved safety;

    —  the standing committee intended to update the detailed annexes had the potential to remove the flexibility and autonomy of individual services, as well as adding a further layer to national decision-making;

    —  the Directive would require the three-yearly re-accreditation of "blood establishments", with annual inspections to ensure compliance, whereas blood services in the UK were granted a licence valid for five years, and inspected every two years; and

    —  it is not clear whether the proposal included hospital blood banks, which are currently not subject to accreditation and inspection.

5.5  The Government concluded that there were likely to be increased costs and bureaucracy without any improvements to blood safety or quality. It would, therefore, prefer the proposal to set out a rigorous body of standards, without codifying how these should be achieved. The Minister said that the Directive was likely to impose additional burdens on the four NHS UK blood services and on the Medicines Control Agency, as well as on the NHS itself, but that these were difficult to quantify at this stage. She also said that consultation on the proposals was taking place with a range of interests, including the relevant professional bodies and patient groups.

5.6  In their Report of 14 March 2001, our predecessors noted that there were good reasons in principle for setting Community standards in this area, and that the main point at issue was whether this proposal did so in a sensible and proportionate way. They also noted the reservations expressed by the Minister, albeit in fairly general terms, that the proposal was likely to give rise to, as yet unquantifiable, costs, and that the Government was consulting a range of interests. They therefore decided to defer any decision until the results of the consultation were known, and the Government had provided some kind of Regulatory Impact Assessment. They added that it would be helpful if the Government could at that stage identify which of the areas of concern referred to in paragraph 5.4 above could be regarded as major.

Supplementary Explanatory Memorandum of 24 October 2001

5.7  In her Supplementary Explanatory Memorandum of 24 October 2001, the present Parliamentary Under-Secretary of State at the Department of Health (Ms Hazel Blears) has drawn our attention to various of the amendments proposed by the European Parliament at its first reading of the proposal on 2 October 2001. Although it appears that the Commission has yet to take a formal view on these, and has thus not so far issued any amended proposal, we understand that attempts will be made to reach a Common Position at the Health Council on 15 November 2001.

5.8  It is also clear that the European Parliament's amendments, if adopted, would have important implications for the proposal. According to the Minister, these would be as follows (in rough order of importance):

    —  All donations of blood would have to be voluntary and unpaid, a provision which would also apply to imported products

      The Minister says that, although all blood collected in the UK currently complies with these requirements, plasma is also collected from paid donors in the USA as a means of reducing risks from nvCJD. She adds that this amendment also raises competence issues, in that it would appear to contravene Article 152(5) EC, which refers to the right of Member States to have their own national provisions on the medical use or donation of blood.

    —  Priority would have to be given to blood from other Member States of the Community

      The Minister points out that this would seem to be a trade issue, and, although she points out that this merely appears in the recital and hence would not be legally binding, it is nevertheless a potential threat to plasma imports from the USA.

    —  All the detailed annexes to the proposal would be deleted

      The Minister says that this is a better option than the existing draft proposal, which is extremely prescriptive and difficult to translate into regulations.

    —  Member States would not be prevented from maintaining more stringent protective measures, so long as these are safety measures based entirely on current scientific knowledge and do not present an obstacle to the implementation of the Directive

      The Minister says that the UK is in favour of such an approach, but is concerned at the word "entirely", since it had in the case on nvCJD to take decisions in the absence of clear scientific knowledge, using the precautionary principle.

    —  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 any medical examination prior to donation would have to be carried out by a doctor rather than a nurse

      The Minister suggests that these amendments are far too restrictive, and would be totally impractical to implement.

    —  There would need to be a universal (possibly computerised) donor identification system

      The Minister does not consider this to be realistic, in that current national identification systems do not jeopardise the principle of traceability.

5.9  The Minister has also attached to her Supplementary Explanatory Memorandum a Regulatory Impact Assessment. This points out that, although the potential risks from infected blood transfusions are very high, the UK currently has one of the safest systems in the world, and that the majority of serious adverse reactions stem from errors made in a clinical setting outside the scope of this proposal. Consequently, its principal benefit will stem from guaranteeing minimum standards across the Community, in relation to those on holiday and (increasingly) patients sent abroad for treatment in order to reduce their waiting time. For that reason, the UK continues to support minimum relevant standards applicable in all Member States, though the benefits are not quantifiable in financial terms.

5.10  So far as the costs are concerned, the Assessment says that the main burden will arise from the inspection requirement, which will increase two fold (from about £95,000 to £190,000 a year) for the Medicines Control Agency (MCA) which currently inspects all four UK Blood Transfusion Services every two years, and — assuming the proposal applies also to hospital blood banks — four fold (from £245,000 to just over £1 million) for the Clinical Accreditation Pathology UK (CPA), which inspects and accredits such banks under a voluntary scheme. However, the Assessment points out that the problem, particularly for hospital blood banks, will be more logistical than financial, arising from the difficulty in recruiting the additional inspectors required.

Conclusion

5.11  Although we are grateful to the Minister for her Supplementary Explanatory Memorandum, this proposal seems likely to provide yet another example of the Council proceeding to a Common Position on the basis of amendments proposed by the European Parliament but before these have been the subject of any amending proposal from the Commission. In other words, whilst we recognise that the Minister is not responsible for this situation, we are nevertheless being asked to scrutinise the measure on the basis of an original document which is being overtaken by events, but before any more up-to-date text is available.

5.12  In view of this, and of the fast-moving nature of the proposal, we do not yet feel able to clear it. In particular, we would like further clarification (i) on the likelihood of the United Kingdom being able to ensure that supplies from third countries will not be jeopardised by any insistence on their being from unpaid donors; (ii) on whether the proposal will apply to hospital blood banks; and (iii) on the extent to which the conditions regarding the medical qualifications needed will be amended to meet the concerns which the Minister has expressed. 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 can see that the latter might well have been over-prescriptive, total deletion appears to risk going to the opposite extreme, and leaving the measure couched in terms too general to be effective. We would, therefore, welcome the Minister's comments on this possibility.



25  Whole blood comprises components such as red cells (which carry oxygen), white cells (which fight infection), and platelets (which help prevent bleeding). Back

26  Plasma is the clear liquid within which the other blood components are suspended. Back


 
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