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EU tissues and cells directive: Proposals for implementation - Public consultation on new regulations
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Launch date:3 June 2006
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Closing date:13 October 2006
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Creator/s:Department of Health
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Copyright holder:Crown
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Gateway number:6457
The EU Tissues and Cells Directive sets standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissue and cells intended for human application.
As work on the second Commission Directive is nearing completion we are now in a position to consult on new Regulations that will bring all three Directives into UK law. The UK currently has two regulatory frameworks covering human tissue: The Human Tissue Act 2004 and The Human Fertilisation and Embryology Act 1990.
These frameworks will remain in place, so the Directives will be implemented in two ways:
- Human tissue and cells - e.g. bone, corneas and skin
- Human reproductive cells - e.g. sperm, eggs and embryos
Human tissue and cells
Regulations will be made that will sit alongside The Human Tissue Act 2004. The Human Tissue (Quality and Safety for Human Application) Regulations will apply the provisions of the Directives to all UK tissue banks and will also establish the Human Tissue Authority (HTA) as the competent authority responsible for ensuring compliance with the Regulations.
A consultation letter, seeking views on the draft Regulations was issued on 3 July 2006.
Human reproductive cells
For gametes (sperm and eggs) and embryos, Regulations will be made to amend the Human Fertilisation & Embryology Act 1990 to bring the requirements of the Directives into law. The Human Fertilisation and Embryology Act (Amendment) Regulations will apply the provisions of the Directives to all establishments handling or distributing gametes and/or embryos in the UK that are intended for human application. They will also establish the Human Fertilisation & Embryology Authority (HFEA) as the competent authority responsible for ensuring compliance with the Regulations.
A consultation document, seeking views on the draft Regulations was issued on 3 July 2006.
- Download Gametes and embryos consultation - Covering letter (PDF, 14K)
- Download Gametes and embryos consultation document (PDF, 100K)
- Download Gametes and embryos consultation - Response proforma (RTF, 18K)
- Download Draft Human Fertilisation and Embryology Act 1990 (Amendment) Regulations (PDF, 78K)
In addition to the Department of Health consultation on the Regulations transposing the Directives into UK law, the HFEA will also be consulting in July 2006 on: the practice standards that establishments will need to achieve in order to comply with the Directives, revisions to its code of practice to take account of the Directives and the fee structure for those establishment that will be coming into regulation for the first time as a result of the Directives. Consultation documents and other information on the HFEA's work toward the implementation of the Directives can be found on its website.
What will it cost?
As part of the consultation process the Department has developed a regulatory impact assessment (RIA), giving a broad outline of the costs to tissue establishments in complying with the Regulations.
Next steps
Following the completion of the consultation exercise, the Regulations will be finalised, taking account of the comments received. The intention is that the Regulations will be placed before Parliament at the end of 2006 with the aim of bringing them into force for April 2007.
Contact information
The consultation closes on 13 October 2006.
As stated in the consultation document, comments on the draft Regulations should be sent to:
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Contact:Scientific Development & Bioethics Division
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