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Issue 3: December 2006

Welcome to the third issue of the Human Tissue Authority e-newsletter.

Update on licensing

The Human Tissue Authority (HTA) has received approximately 500 licence applications to date, covering multiple licensable activities.

We have had the expected number of applications from the sectors for which we were able to make an estimate. For two sectors — public display and storage for research — we were less able to estimate the numbers of applications. We are currently assessing estimated versus actual applications and ask anyone who has not yet applied for a licence, or believes that a centre carrying out these activities without a licence, to contact us immediately, so we can take the necessary action.

Apply for a licence now.

The HTA agreed a system with the Department of Health whereby applications received by 31 August 2006 were deemed to be licensed, pending a thorough evaluation of the self-assessment compliance report. However applications submitted after this date do not fulfil the requirements of the legislation for a deemed licence. Applicants are therefore issued with a short-term licence pending full evaluation of their compliance report. There is an associated administrative fee of £1,100 in addition to the licence fee for such late applications which covers the costs of database development and associated administrative work.

Public display / licences shortfall

The HTA has received fewer licence applications from the public display sector than expected. It may be that there are some establishments storing material without the appropriate licence, thereby acting outside the law. The HTA will be looking into this and will be contacting organisations in the next few weeks. Apply for a licence now.

List of licences issued

The HTA will be publishing a list of categorised licensed establishments in 2007. The HTA has already published a list of deemed licences issued to establishments storing tissue for human application.

The HTA has issued letters confirming the deemed licence status for the majority of applicants who applied by the 31 August deadline — however there are a few outstanding letters to be sent which are subject to some pending queries with the Designated Individual (DI). The deemed licence is issued subject to a full evaluation of the compliance report and eligibility for a deemed licence is only possible if an application was received by the deadline of 31 August 2006.

Post mortem licences

Did you know that establishments which are licensed for the making of a post mortem examination can also apply for additional licences for the removal and storage of tissue for a Scheduled Purpose, for example research, at no extra cost?

One of the HTA's key strategic aims is not to hold up tissue-based research. In this regard we have written to all DIs at establishments licensed for post mortem activities to advise them of the opportunity to apply for a removal licence to remove tissue from the deceased for a Scheduled Purpose including research. There is no additional charge for this licence. If a person who wished to donate their tissue dies in a hospital that does not have a removal licence, there should be systems in place to ensure that the body can be moved speedily to appropriately licensed premises.

Establishments licensed only for storage of material for the Scheduled Purpose of research should have written agreements with those removing tissues on their behalf to ensure there are clear points of contact and lines of responsibility, for example, relating to the obtaining of consent. 

Licence fees

The HTA is working actively to develop a more representative fees model. As part of the process we will carry out a consultation exercise. The new fee levels are expected to be announced early in the new financial year.

Designated Individual training in 2007

The HTA will be holding DI training and sector specific advice sessions throughout 2007 in venues across the UK.

Confirmed dates and venues will be announced shortly —  please check our website for further details. The HTA also plans to provide an online e-learning package for DIs in 2007.

Research exemptions and COREC

The HTA is working with the Central Office for Research Ethics Committees (COREC) to ensure that its forthcoming guidelines dovetail with the HTA's Code of Practice on consent.

The COREC application system will in future fast-track projects that do not present major ethical issues. COREC are also establishing specialist 'flagged' RECs to approve tissue-based research.

On completion of a research project, we would hope that the researchers either apply for a licence for storage for future research projects, or transfer the samples to a tissue bank licensed by the HTA. Disposal should be the last resort.

More information on research exemptions and COREC.

Update on EU Tissue and Cells Directive and associated transposition Regulations

The HTA recently inputted into a consultation on draft Regulations which transpose the EU Tissue and Cells Directive (EUTCD) into UK law.

The Second Technical Directive has now been published in its final form. This brings into the remit of the HTA the regulation of procuring, testing, processing, distributing or importing and exporting tissue and cells for human application. The Regulations are likely to come fully into affect in April 2007.

We will inform tissue establishments about any implications for HTA licensing and inspection process on the regulations have been finalised. In addition we will be publicising the additional licensing requirements that may be needed for establishments that do not currently fall within the licensing framework. More information will be available in the next edition of the e-newsletter.

Adverse events

Regulatory alert

As a result of concerns about a UK patient who suffered an adverse reaction in a hospital abroad whilst undergoing a treatment, the HTA used special directions to retain material held in the UK so that it may be tested. The HTA also issued a regulatory alert to all establishments storing tissue for transplantation (human application) to remind them of their obligations under the HT Act and EUTCD.

In addition to urgent action required by any establishment storing material on behalf of or which originated from ACT/Biomark/CellTech/BioCells, the regulatory alert reminded tissue banks of their requirement to implement a coding and records system which allows the traceability of bodies, body parts, tissues and cells for up to 30 years.

DIs should share the regulatory alert with all those affected by the Human Tissue Act and who work in this licensed area. Did you consider forwarding the alert to your clinical governance lead? The issue of traceability is an important one, which should be addressed at the highest level in the organisation to ensure it is given the appropriate degree of priority. For further information, email kristi.collins@hta.gov.uk.

Reporting system

Under the requirements of the EUTCD, the HTA has to establish a system for the notification of serious adverse events and reactions linked to the procurement, testing, processing, preservation, storage and distribution of human tissues and cells.


Tissue establishments will have to report events and reactions from 1 April 2007. Advice and guidance on how to report and investigate events and reactions will be provided to DIs via workshops and the HTA website in early 2007.

Anatomy schools: donating a body to medical science

The HTA assumed some of the regulatory functions of Her Majesty's Inspector of Anatomy on 1 September 2006. The HTA's role in this area includes managing a system for the donation of bodies for medical education, training and research. Anatomy schools should submit forms for all bodies accepted and received, and for all bodies disposed of, through our secure data-protected online database. Since 1 September, the HTA has received 68 fully completed applications for body donation from anatomy schools.
The HTA website provides information to people enquiring about donating bodies to medical science. To date, the HTA has received about 200 postal and website enquiries and between 5—10 telephone enquiries per week.

Transplantation

Living-donor transplants

The process the HTA introduced on 1 September 2006 to assess live transplants for approval according to the provisions of the HT Act is working well. The average turn around time is two days.

Since the HTA approval system started on 1 September there have been 105 reports submitted by Independent Assessors (IAs), 101 of which have been approved (as of 29 November 2006). The remaining reports are awaiting further clarification before approval can be granted.

The HTA also plans to provide an online e-learning package for IAs in 2007. Re-accreditation of IAs will take place on 1 September 2007 after consultation with the sector.

Cold perfusion: HTA agreement with coroners and the transplant community

From 1 September 2006, the HT Act allowed cold perfusion of deceased non-heartbeating donors — a technique used to preserve organs following death — until the wishes of the deceased can be established or consent obtaining in a qualifying relationship. The HTA is working with the British Transplant Society and the Coroners' Advisory Group on how arrangements for cold perfusion should be agreed locally within the new arrangements.

Bone marrow transplants

The HTA is now responsible for approving bone marrow transplants involving children and adults lacking capacity. As at 29 November 2006, 26 recommendations from Accredited Assessors (AAs) had been submitted to the HTA, all of which have been approved.

The average turn-around time for bone marrow transplant approvals is three days. Unlike the live organ approval recommendations from IAs, the bone marrow cases from AAs are currently referred to the HTA via fax or post, however, we plan to transfer the AA referral process online via the HTA website early in 2007.

An information leaflet for patients on bone marrow transplantation will be published by the HTA in 2007.

Regulatory Authority for Tissues and Embryos (RATE) and the Queen's speech

The 2006-2007 State Opening of Parliament took place on Wednesday 15 November 2006. The Queen's Speech highlighted that "draft proposals will be published to reform the regulation of human embryology".

This was a reference to the draft Human Tissues and Embryos Bill. The Government's aim is to create a new Authority — the Regulatory Authority for Tissues (RATE) — which will combine the functions of the HTA and Human Fertilisation and Embryology Authority (HFEA). A White Paper is likely to be published in December 2006, followed by a Draft Bill. Subject to legislation, RATE is likely to be formed between April 2008 and 2009. The HTA is working with the Department of Health, the HFEA and others in the move towards RATE. See recent article in the Sunday Telegraph.

Meetings

Parliamentary briefing event

The HTA held a successful Parliamentary briefing, hosted by Lord Walton, at the House of Lords on 20 November.

This focussed briefing, which was well attended, provided an opportunity to update Parliamentarians from both houses about the implementation of the HT Act. Lord Walton made complementary remarks about how the HTA has implemented the HT Act. The speakers were Adrian McNeil, Chief Executive of the HTA; Shirley Harrison, Interim Chair of the HTA; Keith Rigg, Transplant Surgeon and HTA member; and James Ironside, Professor of Clinical Neuropathology and HTA member. This briefing also covered:

  • How the HTA is ensuring that tissue-based research continues to thrive in the UK.
  • How the changes in transplants mean more organ donations and a consequent improvement in the quality of life for many more people.
  • How the functions of the HTA and the HFEA will, pending legislation, be combined to form the RATE.

Public Authority meeting

The second HTA public Authority meeting will be held on 20 March 2007 at the Radisson Hotel in Birmingham. Invitations for this meeting will be issued at the end of January, when there will also be open registration on the HTA website.

Consultations

Import and export Code of Practice consultation

The HTA is currently running a public consultation on its draft Code of Practice on the import and export of human bodies, body parts and tissue. This sets out practical guidance for establishments importing and exporting human bodies and tissue, including those storing tissue for transplantation (human application).

The consultation closes on 12 January 2007. The HTA held a well-attended workshop for stakeholders on 5 December 2006 to inform the consultation.

Respond to the consultation on the import export Code of Practice.

UK Health Departments' Code of Practice and guidance on genetic paternity testing services

In the UK, DNA paternity testing services are covered by a voluntary Code of Practice, which sets out acceptable standards for operating in this area. The Code of Practice is currently being revised so that it reflects the review of the court approved paternity list by the Department for Constitutional Affairs (DCA), the introduction of the HT Act 2004 and the HTA's Code of Practice on consent.  The HTA has been actively involved in the revision of the Code, which will go out to a wider consultation —  including private industry — shortly.  For more information about paternity testing in the UK, please visit the Department of Health's website.

Media

A letter to the Lancet by James Ironside in response to the editorial 'Effective implementation of the Human Tissue Act' has been published. This letter clarifies the role of the HTA in the licensing of research.

Adrian McNeil, Chief Executive of the HTA was interviewed on You and Yours on BBC Radio 4 on 2 November in relation to payment of donors for organ transplants.

Staff and vacancies update

Since the last e-newsletter, the HTA have recruited five new regulation managers, who will take up their posts over the coming months. This is as a result of taking inspections in-house for storage of tissue for human application and research and for public display and anatomy and post mortem services. This in-house approach proved to be the most consistent and cost-effective model.

Call for Specialist Assessors

The HTA has begun its programme of inspections of establishments storing tissue for human application (therapeutic tissue banks) and we are keen to recruit experts from the field to help us. More information.

Christmas and New Year opening hours

The HTA office will be closed on 25 and 26 December 2006 and on 1 January 2007. The office will be open on 22 and 27-29 December.

HTA staff will be monitoring transplant submissions from IAs and AAs during office opening hours, as described above.

Previous e-newsletters

Previous copies of the HTA's e-newsletter are available in the publications section of this website.