Statement on regulation of the storage of human tissue for human application

The Human Tissue Act 2004, together with the EU Tissue and Cells Directive has brought the safety and quality of tissues and cells used for transplantation under a new statutory regulatory framework.

Issue date: 8 September 2006

The Human Tissue Act 2004 (HT Act), together with the EU Tissue and Cells Directive 2004/23/EC (EUTCD), has brought the safety and quality of tissues and cells used for transplantation (human application) under a new statutory regulatory framework. The Human Tissue Authority (HTA), which was set up by the HT Act, is one of the competent authorities under the EUTCD for ensuring the Directive is implemented in the UK.

The HT Act does not require licensing of import or export. The HTA’s licensing of the storage of tissues and cells used for human application started in April 2006. The detailed standards of the Directive, including procurement, come into force in 2007. The HTA’s statutory responsibilities under the EUTCD replace the voluntary registration system for tissue banks, which was operated by the Medicines and Healthcare products Regulatory Agency (MHRA) on behalf of Health Ministers.

The HTA does not license the import and export of tissues and cells. The HTA does, however, require establishments storing tissue to have systems and operating procedures to allow an audit trail in case of an adverse event or incident, for example involving a patient. We also ask them to inform us if they import or export tissue and cells.

There is no central collection of data that links tissue samples to import or export. Individual establishments are required to have this information as part of their audit trail. The HTA is obliged to inspect every two years under the EUTCD and we operate a risk-based approach to inspections – inspecting first those we consider may be at highest risk, for example organisations with a complex remit.

The HTA considered and approved a draft Code of Practice on Import and export of human bodies, body parts and tissue at its public meeting on 7 September 2006. It will be issued imminently for consultation. The Code will set out practical guidance for establishments importing and exporting human bodies, body parts and tissue, including those storing tissue for transplantation (human application). The HTA will publish the final Code in early 2007, when the detailed standards of the EUTCD come into force.

When the EUTCD is implemented in 2007 it is likely to contain additional provisions, which will require additional standards to be met by the establishments concerned. This still will not lead to the requirement for a central data source of tissue.

Notes to editors

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 as of 7 April 2006.  All other activities required a licence from 1 September 2006.