Statement on accrediting stem cell banks

Under the EUTCD, the taking of tissue and the testing of donors for infection is covered by one of two regulators – the HTA or the HFEA.

Issue date: 18 April 2007

(Issued on request)

Under the EU Tissue and Cells Directive (EUTCD), the taking of tissue and the testing of donors for infection is covered by one of two regulators – the Human Fertilisation and Embryology Authority (for gametes and embryos) or the Human Tissue Authority (HTA) for all other tissues.

Stem cells can be subjected to a number of steps that are subject to regulation – processing, storing, distribution and import and export. Regulation of these activities depends on whether the tissue is defined as a medicine or medical device.

If the cells are intended for use in transplantation and not classed as a medicine or medicinal device, the HTA would regulate establishments conducting these processes. If they are classed as a medicinal product and are used for treatment or a clinical trial then the establishment would be regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).

We have no remit to licence these establishments at this stage because the regulations transposing the EUTCD into UK law have not yet been finalised.

ENDS

Notes to editors

1. The HTA was established on 1 April 2005 to regulate the removal, storage, use and disposal of human bodies, organs and tissue for a number of ‘Scheduled Purposes’ – such as research, transplantation, and education and training – set out in the Human Tissue Act 2004 (HT Act).
 
2. The HT Act covers England, Wales and Northern Ireland. There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA performs certain tasks on behalf of the Scottish Executive (approval of living donation of organs and licensing of establishments storing tissue for human application).

3. As the regulator under the HT Act, the HTA is responsible for licensing a number of activities and carrying out inspections to ensure licence conditions are being met. These licensable activities include:

• Anatomical examination
• Post mortem examination
• Removal of material from the deceased in certain circumstances
• Storage of post mortem material
• Storage of anatomical specimens
• Storage of material for other purposes – e.g. for human application (transplantation) or research
• Public display of a body or material from a deceased person.

Establishments storing tissue for human application are regulated under the EU Tissues and Cells Directive (EUTCD) and required a licence from 7 April 2006.  All other activities required a licence from 1 September 2006.

4. The HTA is also responsible for approving transplantation of solid organs and bone marrow from living donors. Independent Assessors (IAs) have been accredited to work on the HTA’s behalf to assess applications for all live transplants of solid organs. They act as representatives of the HTA and as advocates for the donor. Accredited Assessors act in a similar capacity to IAs to assess donation of bone marrow by children who are non-Gillick competent and adults who lack capacity.