Select Committee on European Scrutiny Thirty-Eighth Report





COM(02) 319

Draft Directive on setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells.

Legal base:

Article 152(4)(a) EC; co-decision; qualified majority voting


Document originated:

19 June 2002

Deposited in Parliament:

27 June 2002



Basis of consideration:

EM of 8 July 2002

Previous Committee Report:


To be discussed in Council:

See paragraph 24.9 below

Committee's assessment:

Politically important

Committee's decision:





    1. According to the Commission, hundreds of thousands of patients in the Community undergo each year some form of therapeutic treatment based on the use of human tissues and cells[43] from living or deceased donors, and which now goes beyond traditional transplants to such applications as medical devices and products derived through biotechnology. The Commission believes that, in view of the health and ethical considerations[44] to which the use of such material gives rise, and in order to increase public confidence, there should be Community provisions to ensure its quality and safety. In support of this, it points out the considerable discrepancies which exist in the coverage of existing Member State regulations in this area.
    2. The current proposal

    3. It has therefore proposed in this document a draft Directive which would regulate the first three steps (donation, procurement and testing) of the use of all tissues and cells of human origin, except blood and blood products (which are the subject of separate legislation), material used as an autologous graft[45], and tissues used for research purposes when administered to the human body (but not for research in vitro). The further steps in their use (processing, preservation, storage and distribution) would be covered if the tissues and cells are intended for transplantation.
    4. More specifically, the proposal would:

    • require designated competent authorities in each Member State to inspect, accredit, and establish a public register of tissue banking establishments, with only accredited establishments being able to undertake tissue banking functions;

    • require staff engaged in procuring donor tissues and other tissue banking activities to be properly trained, and teams engaged on tissue procurement to be part of an accredited tissue bank or health care establishment;

    • ensure that human tissues or cells intended or used for transplantation are traceable from donor to recipient (and vice versa) for public health reasons within the Community;

    • introduce a monitoring system for adverse incidents and reactions to transplanted tissues;

    • introduce a system for regulating the increasing importation of tissues and cells from third countries, to ensure their safety and quality;

    • set up a Community-wide register of accredited tissue banks;

    • promote the principles of voluntary, unpaid donation (with consent being given expressly and freely), and tissue banking being carried out on a not-for-profit basis (though without making this a strict legal obligation).

The Government's view

    1. In her Explanatory Memorandum of 8 July 2002, the Parliamentary Under- Secretary of State at the Department of Health (Ms Hazel Blears) says that the UK broadly supports the proposal, the aims of which are in line with action already taking place in this country. In particular, the Directive would place the UK's existing voluntary accreditation scheme for tissue banks on a statutory basis, ensuring that they must meet high standards of quality and safety. She also comments that, by standardising practice in the Community, exchanges of human tissue between Member States will become easier.
    2. However, the Minister points out that some requirements would be additional, such as the stipulation that tissue bank and procurement staff should receive a training update every two years, and that Member States should have a system for monitoring and reporting serious adverse events and reactions. She says that, whilst current monitoring arrangements for serious adverse events through the National Patient Safety Agency would provide a framework for the latter, it is likely that the UK would have to introduce more detailed arrangements for the former.
    3. The Minister then identifies a number of specific reservations. These are:

    • that the proposal does not recognise existing arrangements for tissue procurement in the UK, where (unlike some other Member States, in which specialised tissue procurement centres and staff recover tissue) donated tissue is procured by a range of medical and other appropriately trained staff in mortuaries, operating theatres and labour suites (and, in the case of corneas, in funeral directors' establishments or at the donor's home): consequently, the requirement for all such establishments to be inspected would greatly increase both the workload of enforcement authorities and the demands made upon the various establishments, whilst the requirement to register tissue procurement teams, and that they should be part of a tissue bank, would create problems, since there are no dedicated teams as such in the UK. The Minister comments that, although the UK would not want to discourage the development of more specialised procurement teams and centres, it is keen that the proposal should not preclude existing systems, or impose additional inspections on those establishments where tissue is procured.

    • that the UK would prefer the proposal to exclude sperm and egg cells, on the grounds that, as drafted, it would classify as tissue banks those establishments currently regulated by the Human Fertilisation and Embryology Authority (HFEA): since these are already inspected and regulated to a high standard by the Authority, they are excluded from the UK's voluntary accreditation scheme for tissue banks, and their inclusion in the Directive would also prevent establishments regulated by the Authority from advertising for egg and sperm donors;

    • that the Directive would allow only one year for transitional arrangements, which the UK regards as insufficient, and indeed unworkable in that it would require each tissue bank to designate a responsible person who must have worked for two years in an accredited tissue bank;

    • that, in contrast to the present situation in the UK, promotion and publicity activities in support of human tissue donation would have to be approved by a competent authority; the Minister adds that, if such a requirement were introduced, the UK would prefer it to be discharged by an authority different from that inspecting and accrediting tissue banks;

    • that the retention of donor records for 30 years would offer no obvious benefits as compared with the eleven years currently required in the UK, and would require significantly more storage space.

    1. The Minister has also provided with her Explanatory Memorandum a partial Regulatory Impact Assessment. After identifying in general terms the potential benefits from the proposal in terms of risk reduction and more uniform safety standards, this analyses the possible costs for the organisations likely to be affected, which it says include about 100 tissue banks, a broadly comparable number of HFEA registered clinics, all NHS acute hospitals (and about 200 in the private sector), and an unknown number of third parties.
    2. The additional costs, such as they are, would arise in various ways. Inspection and accreditation arrangements already apply voluntarily to most tissue banks, but (depending upon the extent to which the task could be delegated to bodies such as the HFEA) there could be additional enforcement costs if inspection requirements were to extend to other bodies. On the other hand, since most bodies already comply with the prescribed quality and safety standards, this should not in general give rise to significant extra costs. All in all, the Assessment suggests that the overall costs of the proposal as drafted would be around 1 to 2 million, though it adds that the UK hopes in negotiation to reduce these by modifying some of the more serious inspection requirements.
    3. On timing, the Minister simply says that examination of the proposal has commenced, but that the European Parliament's first reading "may not be concluded" before the Health Council on 7 November 2002.
    4. Conclusion

    5. Although there are a number of detailed points on which the Government wishes to align this proposal more closely with the arrangements already applying in the UK, it would seem that its costs are unlikely to be significant, and would in any case need to be balanced against the potential benefits. In view of this, and since the adoption of Community legislation in this area would not appear to give rise to any difficulties of principle, we are clearing the document.


43  This includes bone and musculoskeletal elements, cardiovascular tissues, eye tissues, nerve and brain cells, skin, foetal tissue, reproductive and stem cells, but not organs as such. Back

44  Including prior informed consent and protection of identity. Back

45  Involving tissues or cells removed from and transplanted back into the same person. Back

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