HTA welcomes White Paper

The HTA has welcomed the White Paper which proposes the establishment of the new Regulatory Authority for Tissue and Embryos.

Issue date: 14 December 2006

The Human Tissue Authority (HTA) has today (14 December 2006) welcomed the White Paper which proposes the establishment of the new Regulatory Authority for Tissue and Embryos (RATE).

Subject to legislation, RATE will combine the statutory functions that are currently the responsibilities of the HTA and the Human Fertilisation and Embryology Authority (HFEA).

Bringing all matters concerning human tissue, gametes and embryos under a single framework will ensure consistency of approach in these closely related areas. It also makes sense in terms of European legislation – the HTA and HFEA are both Competent Authorities under the EU Tissue and Cells Directive (EUTCD).

Shirley Harrison, Interim Chair of the HTA said: “We have worked to establish the HTA as a regulator that uses a modern and creative approach. We are fully supportive of RATE and want to see the new Authority combine the best of both the HTA and the HFEA to become a model of better regulation.”

Adrian McNeil, Chief Executive of the HTA said: “We are pleased that the timetable will allow the HTA’s novel regulatory methods to bed in, so that lessons can be fully learnt and implemented. This will mean that RATE and others can benefit from our approach and experience of regulating the human tissue sector.”

In the run-up to RATE, Health Ministers propose to appoint a single individual to separately Chair the HTA and HFEA to move the Authorities further towards working as an integrated whole.

On 20 November 2006, the HTA held a Parliamentary briefing at the House of Lords. This was an opportunity for Parliamentarians and the media to learn more about how the HTA is implementing the Human Tissue Act (HT Act) and the move towards RATE.

ENDS

For further information contact Daisy Thomas at the HTA on 020 7211 3417 or daisy.thomas@hta.gov.uk 
 
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 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 EUTCD and required a licence from 7 April 2006.  All other activities required a licence from 1 September 2006.

4. The conclusions of the Department of Health’s review of its Arm’s Length Bodies (the ALB review) were published in July 2004.  They included the proposal to create a new regulatory body responsible for “the regulation and inspection of all functions relating to the whole range of human tissue – blood, organs, tissues, cells, gametes and embryos”. As such it would replace the HTA and the HFEA.  It would also take over from the Medicines and Healthcare Products Regulatory Agency (MHRA) the responsibility for the regulation of the donation, procurement and supply of blood and blood products. In this way, the new body – RATE – would become the single Competent Authority under the EU Blood and Tissue and Cells Directives, the purpose of which is to secure the safety and quality of blood and tissue and cells used for transplantation, and the sole body responsible for regulatory oversight of activities relating to the use of human bodily material. In the meantime, the HTA would be established in the knowledge that its functions would transfer fully to RATE once new legislation was introduced.

5. The Queen’s speech set out the legislative programme for 2006/2007 and the White paper was published on 14 December 2006. Subject to there being a Bill in the 2007/2008 session, it might be anticipated that RATE would be established in 2009. As well the establishment of RATE, the White Paper proposes an overhaul of the 1990 Human Fertilisation and Embryology Act. In the interim, the HTA is working with the Department of Health and the HFEA to look for further opportunities for joint working in the run-up to the establishment of RATE.

6. More information on the Parliamentary briefing on 20 November is available on request.

7. Since the establishment in 2005, the HTA has implemented a regulatory framework on the lines of best regulatory practice as recommended in the Better Regulation Task Force and Hampton reports (2005). These include:

• Developing a two-tiered licensing framework based on the assessment of risk –including use of self-assessment for initial licence applications followed by detailed desk-based evaluations, and conducting inspections according to risk.
• Implementing a web-based system for licence applications, transplant approvals and body donation and a paperless evaluation process.
• Developing licensing standards and Codes of Practice in collaboration with stakeholders.
• Continuing to provide feedback, advice and guidance, and education and training to the regulated sectors to drive up standards.

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