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Setting standards of quality and safety for the donation, procurement, testing, processing, storage and distribution of human tissues and cells
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Last modified date:8 February 2007
The European Parliament voted on 16 December 2003 to accept amendments to a European Directive which will safeguard high levels of safety and quality for all human tissues and cells used in human applications such as transplantation. The Directive was adopted in Council on 7 April 2004 and must be implemented by 7 April 2006. (However, the Directive contains a provision that allows Member States to decide not to apply the Directive until 7 April 2007 for tissue establishments already bound by national provisions on 7 April 2006.) It will put the current voluntary Code of Practice for Tissue Banks on a statutory footing.
The scope of the Directive will cover all human tissues and cells intended for human application, including in the United Kingdom, around 10,000 patients receiving a human tissue transplant such as bone, skin or heart valves; over 2000 corneal transplants; around 2,000 bone marrow transplants and approximately 35,000 in vitro fertilisation (IVF) cycles. Once adopted the Directive will introduce safety standards across the European Union (EU), facilitating safer and easier exchange of tissues and cells between member states.
The Department is working with the European Commission on the development of Two Commission Directives (the Technical Annexes) to support UK implementation. These are the detailed standards that tissue establishments will need to take account of and will apply to the quality and safety of all tissues and cells for transplantation. It is hoped that the first directive will be finalised by autumn 2005 and the second by summer 2006.
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