Statement on the draft Human Tissue and Embryos Bill

The HTA has welcomed the publication of the draft Tissue and Embryos Bill for pre-legislative scrutiny.

Issue date: 17 May 2007

The Bill proposes the establishment of the new Regulatory Authority for Tissues and Embryos (RATE), which will combine the statutory functions of the HTA and the Human Fertilisation and Embryology Authority (HFEA). The government has proposed the creation of the new Authority to ensure consistency of approach in the regulation of human tissue, gametes and embryos – particularly as the HTA and the HFEA are the Competent Authorities in the UK for implementing the EUTCD in the UK.

Shirley Harrison, Chair of the HTA said: “The HTA is now firmly established as the regulator of human tissue and has the full confidence of the six sectors it regulates. We will take the opportunity provided by pre-legislative scrutiny to emphasise the need for RATE to maintain the hard-won confidence of all the sectors it will come to regulate.”

Adrian McNeil, Chief Executive of the HTA said: “The legislative timetable, including pre-legislative scrutiny, will allow the HTA’s innovative and inclusive approach to regulation to bed in. We want RATE to benefit from, and build on, our methods and experience of regulating the human tissue sector in order to maintain the confidence of professionals and the public.

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 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. 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.

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