Select Committee on European Scrutiny Eighth 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
Document originated: 13 December 2000
Forwarded to the Council: 26 January 2001
Deposited in Parliament: 13 February 2001
Department: Health
Basis of consideration: EM of 26 February 2001
Previous Committee Report: None
To be discussed in Council: No date set
Committee's assessment: Politically important
Committee's decision: Not cleared; further information requested


  11.1  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[30] (such as transfusions) or plasma[31] (notably the manufacture of medicinal products and in vitro diagnostic medical devices). It therefore maintains that, in order to increase public confidence, the Community needs to take action to meet these requirements whatever the intended end-use, and that it needs to cover a number of "complex and inter-related activities", while respecting the responsibilities of the Member States for the organisation and delivery of health services and medical care. The Commission also points out that such a step would have indirect implications for the internal market by facilitating the movement of blood and blood products from one Member State to another, and by removing restrictions on the movement of donors. The ways in which it proposes to achieve these aims are set out in the current document.

The current document

  11.2  The Commission proposes:

    —  that there should be binding standards for the safety and quality of blood and blood components set out in technical annexes;

    —  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 regularly update 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.

  11.3  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 says 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.

The Government's view

  11.4  In her Explanatory Memorandum of 26 February 2001, the Parliamentary Under-Secretary of State at the Department of Health (Ms Gisela Stuart) says that the Government is "fully committed" to the Community strategy on ensuring the safety of the blood transfusion chain, and fully supports the development of a Directive setting high standards of quality and safety in this area. However, she also says that the proposal as it stands raises some concerns. In particular:

    —  it is extremely prescriptive, would be very difficult to translate into regulations, and carries the risk of being out of date as best practice and technology move on - hence, she says, the reason why most safety legislation now sets goals;

    —  that the annexes contain "numerous inaccuracies", and include requirements which serve no useful purpose, and which will increase costs without contributing to improved safety;

    —  the Government would, therefore, prefer the proposal to set out a rigorous body of standards, without codifying how these should be achieved;

    —  the standing committee which it is envisaged would update the detailed annexes has the potential to remove the flexibility and autonomy of individual services, as well as adding a further layer to national decision-making (currently carried out in the UK by the Advisory Committee on the Microbiological Safety of Blood and Tissues for Transplantation);

    —  the Directive would require the three-yearly re-accreditation of "blood establishments", with annual inspections to ensure compliance, whereas the Medicines Control Agency in the UK currently issues blood services with a licence valid for five years, and inspects each blood centre every two years; and

    —  it is not clear whether the definition of "blood establishments" includes hospital blood banks, which are currently not subject to accreditation and inspection, and more generally, the Government is concerned at the likelihood of increased costs and bureaucracy without there being any improvements to blood safety or quality.

  11.5  The Minister says that the Directive is 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 are difficult to quantify at this stage. She also says that consultation on the proposals is taking place with a range of interests, including the relevant professional bodies and patient group.


  11.6  As the Minister says, there are good reasons in principle for setting Community standards in this area, and the main point at issue is whether this proposal does so in a sensible and proportionate way. On that, we note the reservations expressed by the Minister, albeit in fairly general terms, and that the proposal is likely to give rise to, as yet unquantifiable, costs. We also note that the Government is consulting a range of interests.

  11.7  In view of this, we are deferring any decision on the document until the results of the consultation are known, at which point we assume the Government will let us have some kind of Regulatory Impact Assessment. It would also be helpful if the Minister could at that stage identify which of the areas of concern referred to in paragraph 11.4 above could be regarded as major.

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

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

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