Launch of public consultation on Code of Practice on the import and export of human bodies and tissue

The HTA has today launched a consultation on its Code of Practice on the import and export of human bodies, body parts and tissue.

Issue date: 3 October 2006

Human bodies and tissue are imported into the UK mainly for use in medical education and training, research and public display. And human tissue and cells are exported from the UK usually to be processed for human application or used for research.

The storage and use of human tissue that is imported into England, Wales and Northern Ireland, will be licensable by the HTA under the Human Tissue Act if it is stored for a Scheduled Purpose – for example in the case of tissue stored for human application. Establishments must have systems in place to allow an audit trail in case of an adverse event or incident, for example involving a patient.

The draft Code lays down practical guidance and standards on the import and export of tissue from living people (for example a biopsy stored for future research) and from the deceased. This includes material that is frozen, plastinated or preserved in some way. Failure to observe the principles set out in the Code may influence licensing decisions made by the HTA.

The HTA is asking professionals and the public to respond to the consultation on the draft Code of Practice. The consultation period will end on 12 January 2007.

Commenting on the consultation Adrian McNeil, Chief Executive of the HTA said: “The Code of Practice on the import and export of human tissue reinforces the fundamental principles of the work of the HTA – that informed consent is given and that bodies and body parts are treated with dignity and respect. The Code sets out clear requirements for storing and using imported and exported human tissue, and good practice that should be followed by establishments which do not carry out activities that are licensable under the Human Tissue Act.

“It is important that professionals and the public respond to the consultation on the Code of Practice, so that the views of as many people as possible are incorporated into the final guidance.”

The HTA is holding a consultation workshop in London on 5 December 2006 which will enable HTA stakeholders to further feed into the consultation process.

ENDS

For further information contact the HTA: Stuart Giblin 020 7211 3416, stuart.giblin@hta.gov.uk or Daisy Thomas 020 7211 3417, daisy.thomas@hta.gov.uk 
 
Notes to editors
 
1. The consultation on the HTA Code of Practice on the import and export of human bodies, body parts and tissue runs from 3 October 2006 until 12 January 2007. Comments on the consultation are welcome via this website - respond to the consultation

2. Registration for the consultation workshop on 5 December 2006 is available on this website - register to attend the consultation workshop

3. The Code of Practice was drafted by members of the HTA's import and export working group which included representatives from the research, academic and private sectors, as well as members of the Authority.

4.  The geographical scope of “import” and “export” according to the Human Tissue Act are as follows:

• “import” means import into England, Wales or Northern Ireland from a place outside England, Wales and Northern Ireland;
• “export” means export from England, Wales or Northern Ireland to a place outside England, Wales and Northern Ireland.

5. 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).
 
6. The HT Act covers England, Wales and Northern Ireland. There is separate legislation in Scotland – the Human Tissue (Scotland) Act 2006 – and the HTA will perform certain tasks on behalf of the Scottish Executive (approval of living donation of organs and licensing of establishments storing tissue for human application).
 
7. 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 are:

• Anatomical examination
• Post mortem examination
• Removal of material from deceased persons in certain circumstances
• Storage of post mortem material
• Storage of anatomical specimens
• Storage of material from a living person (e.g. for 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 and required a licence from 7 April 2006.  All other activities required a licence from 1 September 2006. The HTA does not license the removal, storage and use of tissue for diagnosis or treatment.

8. The HTA has published six other Codes of Practice: Code of Practice 1 – Consent; Code of Practice 2 – Donation of organs, tissue and cells for transplantation; Code of Practice 3 – Post mortem examination; Code of Practice 4 – Anatomical examination;  Code of Practice 5 – Removal, Storage and disposal of human organs and tissue, Code of Practice 6 – Donation of allogenic bone marrow and peripheral blood stem, cells for transplantation. The HTA has also recently published guidance on public display of human bodies and tissue.

9. Subscribe to the HTA e-newsletter ‘Current issue’ to keep up-to-date with the work of the HTA.