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Issue 8: December 2007

Welcome to the December issue of the Human Tissue Authority’s e-newsletter which provides updates for all the sectors we regulate.

In this issue we announce two upcoming HTA events planned for March 2008 – our next public Authority meeting which will be held in Cardiff and a conference on regulating tissue and cells for the human application sector. We also give an update on licensing and clarify our remit on embryonic stem cell lines.

For the transplant community, this issue includes a report from our recent Independent Assessor’s conference and a link to our written evidence to the Select Committee on the EU inquiry into organ donation.

If you have any comments or queries about the issues raised in this e-newsletter, or any ideas for items that you would like to see in future, please contact us at enquiries@hta.gov.uk


Public Authority meeting – 18 March 2008

The HTA holds two Authority meetings in public every year, one of which takes place outside London. The next public Authority meeting will be held on Tuesday 18 March 2008 in Cardiff.

This meeting provides an opportunity to observe the Authority discussing its business and there will also be an opportunity for you to put questions directly to the Authority.  If you would like to attend the meeting, please register.

Dates of future Authority meetings and minutes from past meetings.

Recent media stories about human tissue

Paired kidney donation

The HTA recently held a press conference and issued a media release to announce the UK’s first paired kidney transplant. Read the media release and press pack.

Regulation of research

A letter from Adrian McNeil, HTA Chief Executive, was published in The Times, in response to an article suggesting that regulation holds back research.

Read the letter

Update on licensing and inspections

Embryonic stem cell lines

Now that the EU Tissue and Cells Directives (EUTCD) has been fully implemented, the remit of the HTA has been extended to cover the regulation of all cell lines grown outside the human body for human application.

If cell lines are processed, stored, distributed, imported or exported with the intention that they could potentially be used for human application, an HTA licence is required under the Human Tissue (Quality and Safety for Human Application) Regulations. More information, including the remit of other regulatory bodies in relation to embryonic stem cell lines, is available on the following pages:

Please note: the HTA regulates under the EUTCD the procurement, processing, storage, distribution, and import / export of all stem cell lines – both embryonic and non-embryonic – for human application.

HTA regulatory action

A report containing a summary of regulatory action taken by the HTA will be provided to Authority members on a regular basis. The first report was considered by the members at their November meeting. You can read the report and the others papers from the November meeting on the Authority meeting papers page.

HTA e-learning courses

Designated Individuals

Our e-learning course for Designated Individuals (DIs) will be launched in January. The course has been designed to train DIs on the core knowledge required to carry out their day-to-day duties under the Human Tissue Act. We will contact all DIs when the system is launched with details about how to access the course.

Thank you to those DIs who took part in user-testing. Your feedback was greatly appreciated and has helped shape the final version.

Independent Assessors

In the last e-newsletter we included information about the e-learning course for Independent Assessors (IAs) which was launched earlier this year. This e-learning course has been designed to train new IAs, and to reaccredit some existing IAs on an annual basis.

IAs required to complete the course for reaccreditation this year should have done so by the end of November. Those who have not, are asked to do so without delay.

The e-learning course has now received CPD approval from the Royal College of Physicians (RCP). This means that completion of the e-learning course will allow IAs who are members of the RCP to accrue CPD credits.

The course is also useful for other staff in transplant units to increase their understanding of how the HTA approvals process works. The IA e-learning course is open to all from the IA page of this website.

Advisory Committee on the Safety of Blood, Tissues and Organs

The Advisory Committee on the Safety of Blood, Tissues and Organs (ACSBTO) has been established by the Department of Health to provide independent scientific advice to the Government on the most appropriate ways to ensure the safety of blood, tissues and organs used for transplantation. Recruitment of a Chair and members for ACSBTO is currently taking place. The HTA has been appointed as an observer and we will be working collaboratively with this new Committee.

Information for the human application sector

Regulating tissue and cells for human application: the past, the present, the future conference – 25 March 2008

On 25 March 2008, we will be holding a conference for establishments in the human application sector.

This conference will provide a valuable opportunity to discuss the requirements of the Human Tissue (Quality and Safety for Human Application) Regulations in more detail, and to network with representatives from other licensed establishments and also from the European Commission. The day will consist of a series of presentations and breakout seminars that will consider past, present and future issues of relevance to this diverse sector.

The conference will take place at the Wellcome Collection Conference Centre in London. Further information.

In January we will also be issuing invitations to all Designated Individuals and Licence Holders of establishments licensed for human application. We will provide an update about the conference in the February issue of the e-newsletter.

Annual activity report

The EU Tissue and Cells Directive (EUTCD) states that tissue establishments must submit an annual report of their activities to their Competent Authority, and that this report should be publicly accessible.

HTA Directions 001/2006 and 002/2007 provide details of what is required from the annual report.

We are asking all licensed establishments to provide us with this information in a format of their choice by the end of January 2008, for the period 5 July to 31 December 2007. Future reports will be for the whole preceding calendar year.

Further information about this, including contact details, will be available on this website soon.

European coding system

Under the EUTCD, Member States have an obligation to establish a coding system for the identification of human tissues and cells, to ensure their traceability. The European Commission is also required to design a single European coding system in cooperation with Member States, to provide information on the main characteristics and properties of tissues and cells.

The European coding system will have a significant impact on human application establishments.  A consultation is currently taking place on the proposed coding system and the HTA will be responding to this. If your establishment would like to respond, you can find out more on the EC website.

The closing date for responses is 15 January 2008.

Information for the anatomy sector

HM Inspector of Anatomy for Scotland

Professor Robert Wood has now been appointed as HM Inspector of Anatomy for Scotland. We have updated our website with a central contact for body donation enquiries from the public in Scotland. People living in Scotland who would like to donate their body to medical science should contact Richard Dimelow at: richard.dimelow@scotland.gsi.gov.uk or 0131 244 5184.

Designated Individual workshop

We will be holding our next Designated Individual workshop for the anatomy sector on 28 February 2008. This will be held at Holborn Bars. Invites will be sent out shortly.

Information for the post mortem sector

Designated Individual workshop

We will be holding our next Designated Individual workshop for the post mortem sector on 28  February 2008. This will be held at Holborn Bars. Invites will be sent out shortly.

Information for the organ and bone marrow transplants sector

Organ donations

From 1 April 2007 to 20 November 2007, 638 reports from IAs were submitted to the HTA, 632 of which were approved. Six cases are currently awaiting more information before they can be adequately assessed. Since 1 April, 12 cases have been referred to a panel of HTA members for a decision.

Bone marrow transplants

From 1 April 2007 to 20 November 2007, 42 reports from Accredited Assessors (AAs) were submitted to the HTA, all of which have been approved.

Independent Assessor conference

Our first IA Conference on 23 October 2007 was attended by IAs and transplant unit members. This was the first event of its kind, and provided an opportunity for networking and sharing experiences of the HTA’s transplant approval process.

A briefing which summarises the issues explored on the day and the scenarios considered in workshops, along with notes from the question and answer sessions, is available in the past events section of this website.

Interim guidance on withdrawal of consent in deceased donation cases

The HTA has recently issued interim guidance on the withdrawal of consent and deceased organ donors. Download the guidance.

HTA evidence to the Select Committee on the EU inquiry into organ donation

The HTA has recently submitted evidence to the Select Committee on the European Union’s inquiry into ‘Communication on organ donation and transplantation: policy actions at EU level’.

Our evidence covers the issues raised by the Committee and other relevant issues which relate to the work and remit of the HTA. Read the HTA evidence.

Christmas and New Year 

The HTA office will be closed on 25 and 26 December 2007 and on 1 January 2008 (although this will not affect transplant approvals). The out of hours service for emergency organ transplants (usually liver failure) will operate over the whole Christmas period.

Previous e-newsletters

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

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