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Issue 2 October 2006

Welcome to the second issue of the Human Tissue Authority e-newsletter. 1 September 2006 was a key milestone for the HTA as the Human Tissue Act 2004 (HT Act) came fully into force. The new legislation means that for the first time post mortem services, anatomy schools, establishments storing tissue for research, and sites displaying human tissue, such as museums, must have an HTA licence in order to operate lawfully.

This was the second important licensing date for the HTA – we also started licensing establishments storing tissue for transplantation (human application) from 7 April 2006 as part of our responsibility as Competent Authority to implement the EU Tissues and Cells Directive which comes fully into force in 2007.

The HT Act covers England, Wales and Northern Ireland. The Human Tissue (Scotland) Act 2006 also came into force on 1 September. The HTA will perform certain tasks on behalf of Scottish Ministers – approval of living organ donation and licensing of establishments storing tissue for human application. Further information about the Human Tissue (Scotland) Act 2006 and about the Scottish requirements relating to living organ donation.

Licence applications

The HTA received 353 licence applications through our website compliance report licence application forms by the 31 August deadline. 110 of the applications were for research licences, 194 for pathology, 39 for anatomy and 10 for public display. This is in addition to the 118 licence applications we received in April from establishments storing tissue for human application.

The process for licence applications and their evaluation is now as follows:

Applicants who submitted their licence application by 31 August

All establishments who submitted their licence application by 31 August for the 1 September deadline are deemed to be licensed. Since 1 September we have been importing these large and complex data files from the website to our licensing management system and have been cleansing and validating data during the transfer. We aim to issue applicants with a deemed licence in October to confirm that they can continue to operate within the law while we evaluate their application. These establishments will also be sent an invoice for the licence fee and an evaluation form to help us improve our effectiveness as a regulator.

Once a licence application has been evaluated, we will inform the establishment in writing of the licensing decision based on our evaluation and may send them a licence offer. The establishment then has 28 days to accept the licensing decision or to advise us that they wish to make representations against it.

Late licence applications

Some establishments applied for a licence after the 31 August deadline or have informed us that their application will be delayed. We have written to those establishments that have not applied for a licence and are closely monitoring their progress before deciding what enforcement action we will take. Anyone carrying out a licensable activity without an HTA licence is operating unlawfully and must apply for a licence as a matter of urgency. We are also monitoring those establishments we were expecting to apply for a licence but have not yet done so.

Apply for a licence now.

The HTA is organising further training days for Designated Individuals. Details of these training days and an online registration form will be available on the website. We are also planning a series of sector-specific events in 2007.

Inspections

The HTA has now opted for an in-house inspectorate for four of the sectors we license.

They are: establishments storing tissue for transplantation, anatomy schools, museums storing material for public display and establishments storing material for research. We have professional inspectors in-house and, where appropriate, during the first year of our inspections we will also work with independent specialist assessors representative of the sectors we license.

We are starting a recruitment drive to expand our in-house inspection team. We are particularly looking for people with a scientific background to join us as Regulation Managers. Details of HTA job vacancies are available on our website.

Consolidation of tissue stocks

As a result of the HT Act coming into force, research institutions have audited their holdings of their tissue samples and in some cases have consolidated them into fewer or even central repositories.

Belinda Seeto, Project Manager at the Human Tissue Resource Centre at Barts said: “In response to the Human Tissue Act, we at Barts have set up a centralised Human Tissue Resource Centre to ensure compliance with the Act and with the Human Tissue Authority’s Codes of Practice.” Other institutions that have consolidated their tissue samples include the London Medical School, Cancer Research UK, Birmingham University, Leicester University and Queens University Belfast.

Read an article in The Scientist about consolidation of tissue stocks.

The HTA wrote to all Vice Chancellors of Universities and Chief Executives of Trusts earlier this year to provide an audit tool to allow them to assess their tissue stocks.

Storage of tissue for human application

In the last week, the HTA learnt that a UK patient treated overseas was admitted to hospital with an adverse reaction to treatment using stem cells.

In view of concerns over this and issues relating to traceability, the HTA decided that the material should be retained so it may be tested, if necessary, as part of any future investigation. The HTA is liaising with the Irish Medicines Board and the Dutch Medical Inspectorate in this regard. The HTA will shortly issue a regulatory alert to all establishments storing tissue for transplantation (human application) to remind them of their obligations under the Human Tissue Act and EU Tissue and Cells Directive.

Events and meetings

Media briefing 30 August 2006

A second successful media briefing event was hosted by the Science Media Centre on 30 August 2006. This briefing provided an opportunity for media to learn more about the far-reaching implications of the HT Act and the HTA’s regulatory framework. There was a considerable amount of media coverage as a result of the briefing, which focused on the changes around deceased organ donation. Living organ donation, licensing by the HTA, and the offence of DNA testing were also frequently mentioned.

Read the media coverage from the media briefing and other articles which have recently been published about the HTA, including those in Hospital Doctor and the British Journal of Nursing.

Public Authority meeting and report-back event 7 September 2006

On the morning of 7 September the HTA held its first public Authority meeting. This provided members of the public and other HTA stakeholders with an opportunity to observe the decision-making process of the Authority. The minutes from the meeting will be published on the website in October. 100% of attendees who responded to an evaluation form said that they have confidence in the decision-making process of the HTA after observing the meeting.

The HTA's annual report-back meeting took place on the afternoon of Thursday 7 September 2006. This was a public-focused meeting, looking back at our work over the last year in setting up the new regulatory authority. Our first Annual Report and Accounts was also launched at the event. The speakers included the Rt Hon Rosie Winterton MP, Minister of State for Health Services. A transcript of her speech is available. 83% of attendees who responded to an evaluation form said that following the event they feel better informed about how the HTA works.

Public display guidance

The HTA has published its revised guidance on the public display of human bodies, body parts and tissue following an extensive consultation.

The guidance provides a definition of public display and supplements the HTA's licensing standards and Code of Practice on consent. Taken together, these three elements form comprehensive guidance on complying with the public display requirements of the HT Act.

Download guidance on public display. A series of frequently asked questions about public display is also available.

Consultations

Import and export Code of Practice consultation

The HTA is currently running a consultation on the draft Code of Practice on the import and export of human bodies, body parts and tissue. The Code 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.

Respond to the consultation on the import export Code of Practice

The HTA is holding a consultation workshop on 5 December 2006 in London to allow stakeholders to further feed into the consultation process. Regsiter for the consultation workshop.

Department of Health consultation

The Department of Health consultation on draft Regulations to transpose EU Directives covering donation, procurement, testing preservation, storage and distribution of tissue and cells for human application into UK legislation closes on 13 October 2006. Electronic copies of the consultation documents are available from www.dh.gov.uk/consultations

DNA testing companies

It is an offence under Section 45 of the HT Act, to have any bodily material (i.e. material which has come from a human body and which consists of or includes human cells) with intent to analyse the DNA in it without qualifying consent, subject to certain exceptions. This offence applies to the whole of the UK.

The HTA has recently written to a number of DNA testing companies requesting that they take urgent action to review the content of their websites and their practices to ensure that they are complying with the HT Act and the HTA Code of Practice on Consent. Further information.

Website

The HTA website has recently been updated with additional information for the anatomy and organ donation communities.

Anatomy

A new section has been added ‘Donating a body to medical science’.This section provides information for people who wish to donate their body for medical education or research, and contact details for all anatomy schools which accept donation of bodies with a list of which anatomy schools cover which postcodes. The section also provides information for anatomy schools, including access to the online database which schools should use to submit forms HTA(A)2 and HTA(A)4 for all bodies accepted, received and released. From this section, anatomy schools can also download the HTA bequeathal booklet and model consent form.

Transplantation

Further information has been added to the transplantation section of the website about organ donation and bone marrow and stem cell donation . Guidance for Independent Assessors (IAs) and Accredited Assessors,  who work on our behalf in these areas, has also been published, and there is access to the online submission system for IA reports. The HTA will produce a patient information leaflet on bone marrow and stem cell donation.

The HTA has appointed a new transplant manager, Rebecca Halpin, who is responsible for ensuring that the new arrangements for approving donation of organs from living people are rapidly and effectively established. Rebecca will in due course evaluate how the system is working and make recommendations on how it can be improved. The turn-around time for HTA approval of an organ donation is five working days in straightforward cases. For more complex cases, the turn-around time is 10 working days following submission to the HTA panel.

HTA Chair

Baroness Hayman stepped down from her role as Chair of the HTA on 30 September to become Speaker of the House of Lords.

She led the Authority for 19 months, during which time it has developed and mature into an organisation that is pragmatic and well regarded. Both the Authority Members and the Executive are enormously grateful to her for her leadership, wisdom, wit and good sense.

Information about the new Chair of the HTA is provided in the next section.

Regulatory Authority for Tissue and Embryos

It is the Government’s intention to form a new organisation – the Regulatory Authority for Tissue and Embryos (RATE) – which will be responsible for regulating human tissue, gametes and embryos.

This new organisation will combine the statutory functions that are currently the responsibility of the HTA and the Human Fertilisation and Embryology Authority (HFEA). The Department of Health has already signalled that it will want to talk to our stakeholders about what the new organisation will look like and what regulatory principles and values it should hold.

We understand that there is likely to be an announcement about the draft Bill for RATE in the Queen’s speech in November. The Department of Health are planning to appoint a joint Chair for the HTA and HFEA in the run-up to the establishment of RATE. In the meantime, Shirley Harrison has been appointed as the interim Chair of the HTA. Shirley, who was previously a lay member of the Authority, took up the role on 1 October.

An advertisement for the joint Chair of the HTA and HFEA has appeared in the national press and further informtion is available on the NHS Appointments Commission website.