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NHS
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HDL(2001)27
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Health
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HUMAN TISSUE BANKING FOR THERAPEUTIC PURPOSES 1. I have pleasure in enclosing the final version of A Code of Practice for Human Tissue Banking for Therapeutic Purposes which sets out the principles of good practice that should exist in all such banks. If you are responsible for a human tissue bank, or are a clinician who uses therapeutic tissues supplied by a tissue bank, you need to be aware that a regulatory scheme based on the requirements of the Code of Practice will be starting from 1 April 2001. 2. The Code was prepared by the Health Departments in consultation with the Royal Colleges and relevant professional organisations. Further copies of the Code are available from: MCA Information Centre, 10th Floor Market Towers, London SW8 5NQ (Tel: 0207 273 0000 or E-mail: info@mca.gov.uk). It can also be downloaded from the DH website: www.doh.gov.uk/humantissuebanking. Tissue banks are defined by the Code as organisations that are responsible for the retrieval, processing, packaging, labelling, storage and delivery of the finished tissue before it is issued under their name, regardless of whether these operations are carried out by that organisation or on their behalf by a third party. 3. The scheme of accreditation based on the Code will begin with a 2-year interim phase, after which - from 1 April 2003 - Trusts will be expected to obtain human tissues for transplantation only from accredited banks. These will be banks which have been inspected and found to comply with the Code. A team from the Medicines Control Agency (MCA) will inspect banks and keep a database of those which have been accredited. Details about the operation of the scheme and application forms to join it will be available from mid-February from the Licensing Office, MCA, Room 17/101 Market Towers, London SW8 5NQ. There will be no fee for NHS tissue banks joining the accreditation scheme in the first 2 years. |
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4. Apart from compliance with the Code of Practice, you are reminded that tissue banks must also operate within a set of ethical principles: Proper consent to donation must be obtained, and donation from cadavers must be made unconditionally and on the understanding that the tissues will go to patients according to clinical need. It is also fundamental that commercial dealings in human organs and tissues are prohibited, although the full costs of supplying tissues may be recovered from the recipient organisations. Those costs may quite properly include the expenses involved in any changes necessary to bring the bank up to standard, and, after the initial period, any fees for inspection and accreditation. 5. Your attention is also drawn to the recent HDL which advises that the Scottish National Blood Transfusion Service is the Department's preferred service provider of bone and tissue services for NHSScotland. Yours sincerely
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