Issue 7: October 2007
Welcome to the October issue of the Human Tissue Authority’s e-newsletter which provides updates for all the sectors we regulate.
In this issue we provide guidance about the storage of bone products, and an update on the use of images in the anatomy sector. Following your feedback, we also clarify the processes for changing a Designated Individual or Licence Holder.
This issue marks the launch of our new interactive e-learning course to train Independent Assessors, who work on behalf of the HTA to approve organ transplants from living donors. Read on to find out how you can access the course.
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
HTA public Authority and report-back meetings
Thank you to everyone who attended our public Authority and annual report-back meetings on 6 September 2007 at the Wellcome Collection Conference Centre.
During the public meeting, attendees saw the HTA discussing its business. The papers from the meeting are available on this website. The minutes from the meeting will be available in October.
85 people attended the annual report-back meeting, during which we launched our Annual Report and Accounts, and announced the results of our stakeholder evaluation project with Ipsos MORI. This project evaluated the views of the public and of opinion leaders, about the work of the HTA and issues in our remit. The report of public attitudes to human tissue is available on this website.
Update on recent media stories about human tissue
Regulatory Authority for Tissue and Embryos (RATE)
The Joint Committee on the Draft Human Tissue and Embryos (RATE) Bill published its report at the beginning of August. The Bill included the proposal to form RATE which subject to legislation would combine the statutory functions of the HTA and the HFEA. The report from the Joint Committee recommended that the HTA should stay as a separate Authority. We expect that the Government will publish their response to the report during October.
Presumed consent
The HTA released a statement in response to the announcement by Health Secretary Alan Johnson (20 September 2007) that the organ donation taskforce will explore the issue of presumed consent. The statement is available in the news section of this website.
Research and biobanks
A special issue of the journal Pathobiology included a series of articles about research and biobanks. These included ‘Tissue banking in a regulated environment – does this help the patient?’ and ‘Legal aspects of tissue banking’. A link to the journal is available on the HTA's EUTCD page.
Codes of Practice update
We are going to update our first six Codes of Practice and public display guidance, to take on board comments from our stakeholders and policy developments at the HTA.
We will issue the revised versions of the Codes for consultation, at which point all stakeholders will have the opportunity to contribute. We expect this to take place in summer 2008.
Our current Codes of Practice are available in the guidance section of our website.
Launch of e-learning course
IA e-learning
The HTA has recently launched a new interactive e-learning course for Independent Assessors (IAs).
The HTA trains IAs so that they can make recommendations about whether living-donor transplant operations should take place. The e-learning course has been designed to train new IAs, and to help reaccredit existing IAs on an annual basis. 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 and you can access it on the HTA's website.
If you do not already have an HTA username and password, you will need to register for one in order to log in to the course.
DI e-learning
Another e-learning course will be launched later this year to train Designated Individuals and other staff in HTA licensed establishments.
Living donor transplants update
Organ donations
From 1 September 2006 to 19 September 2007, 784 reports from IAs were submitted to the HTA, 780 of which have been approved. Two cases have not been approved, and four cases are currently awaiting more information before they can be adequately assessed. To date, nine cases have been referred to a panel of HTA members for a decision. Further information can be found in our Independent Assessor bulletin.
Bone marrow transplants
From 1 September 2006 to 19 September 2007, 90 reports from Accredited Assessors were submitted to the HTA, all of which have been approved. Further information can be found in our Accredited Assessor bulletin.
IA conference
On 23 October 2007, the HTA will be holding the first IA Annual Conference at the Welcome Collection Conference Centre in London. The conference will be attended by IAs and representatives from transplant centres throughout the UK.
The conference will provide a valuable opportunity to review the first year of the HTA’s regulation of living organ donation. IAs will have the opportunity to network, and to discuss the transplant approval process and their experiences of working with it. The day will also provide us with an opportunity to understand any issues and problems that IAs may be facing, and to consider developments for the future.
We will provide an update on the outcomes from the conference in the next e-newsletter. If you have any questions about the conference or are interested in attending please email transplants@hta.gov.uk.
Information for the human application sector
Licence variations
We have written to all Designated Individuals and Licence Holders in establishments that are licensed to store tissue for human application, about variations to their licence in order to comply with the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
A separate letter has been sent to the Cornea Transplant Services (CTS) eye banks. This is due to the fact that the variations proposed for the CTS eye banks contain additional conditions specific to this group of establishments.
If you are a DI or Licence Holder at a tissue bank and have not received your letter, please contact Hazel Uppington, Regulation Manager, at hazel.uppington@hta.gov.uk or 020 7211 3409.
Directions 004/2007
We have recently issued a new set of Directions (004/2007), as required under the Human Tissue (Quality and Safety for Human Application) Regulations 2007. These Directions ensure that imports of tissues or cells intended for human application, from countries which are not member states of the European Economic Area (EEA), meet the quality and safety standards of the Regulations. (The EEA states include member states of the EU, plus Iceland, Liechtenstein and Norway.)
The Directions come into force on 7 October 2007 and apply only to imports from non EEA states. You can read the Directions on the HTA's website.
Procurement, testing, processing, distribution and import and export
Procurement, testing, processing, distribution, and import and export of human tissue intended for human application are now licensable activities under the Regulations. We will shortly be writing to organisations that may be affected by changes in licensing brought about by the Regulations.
Bone products
Following a number of enquiries, we have been liaising with NHS Blood and Transplant (NHSBT) about their washed bone and tendon products. NHSBT deem that tendons and washed bone products, which have undergone their processes, are acellular. This means that they are not classed as ‘relevant material’ under the HT Act.
NHSBT’s website includes product sheets that describe which products require a storage licence from the HTA. NHSBT will also be sending user information packs to establishments that purchase these products. Further information is available on the NHSBT website.
Information for the anatomy sector on the use of images
We are currently undertaking a review of the advice that we have provided to the anatomy sector on the use of images. Real-world scenarios and case studies have provided us with helpful material to review our regulatory position on this issue. We will issue further guidance once we have completed the review. In the meantime, please refer to our Code of Practice on anatomical examination on the guidance page of our website.
For further information and if you have any comments you would like the review to consider, please contact Chris Birkett, Regulation Manager on 020 7211 3444 or email christopher.birkett@hta.gov.uk . Or contact Kristi Collins, Head of Regulation on 020 7211 3413 or email kristi.collins@hta.gov.uk
Information for the research sector
Regulation and clinical research
We are aware that there may be some research projects (and clinical trials), taking place within the NHS that require an HTA licence under the Human Tissue (Quality and Safety for Human Application) Regulations 2007.
Any research or trial that involves the procurement of tissues and cells for use in allogeneic or autologous application requires licensing. The licensing requirement applies irrespective of ethical approval. If a clinical trial is regulated by the MHRA then a licence for some activities may not be required. Further information is available online at the HTA's Frequently Asked Questions page.
If you think that you may require an HTA licence please email licensing.enquiries@hta.gov.uk
Licensing issues
Changing a Licence Holder or Designated Individual
We regularly receive enquires from licensed establishments about the process for changing a Licence Holder (LH) – who may be an individual or corporate body – or Designated Individual (DI).
The process for this is explained on our website, where you can also download the relevant forms on this website.
All sections of the appropriate form/s must be completed. The forms may be submitted electronically or in hard copy by post. Once received, the HTA’s Regulation Directorate will review the information provided and determine the suitability of the proposed new DI or LH.
As a change to the Designated Individual or Licence Holder represents a material change to the licence, the HTA will issue both parties with a new licence offer letter.
Representations process
The HT Act allows LHs or DIs to make representations and appeals to the HTA against licensing decisions. Information about the representations process is available on this website. If you would like more information, please contact Christiane Niederlaender, Regulation Manager, at christiane.niederlaender@hta.gov.uk or 020 7211 3446.
Previous e-newsletters
Previous copies of the HTA's e-newsletter are available in the publications section of this website.
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