Issue 14 December 2008
Welcome to the December issue of the Human Tissue Authority's e-newsletter
The e-newsletter is the main way that we communicate changes to our regulatory policy and so is essential reading if you work in one of the sectors that we regulate. We now have more than 4600 subscribers. We also use the e-newsletter to let you know about new advice and guidance, and important updates to our website.
This issue includes information about how you can take part in our licence fee consultation and details about future Designated Individual training events. You can also read our revised guidance on the definition of 'relevant material'.
For the transplant community this issue includes a report from our recent Independent Assessor conference and information about transplant approvals over the Christmas period.
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.
The HTA office will be closed on 25 and 26 December 2008 and on 1 January 2009. The office will be open on 24 and 29–31 December 2008. We wish all our readers a happy festive season.
Consultations
Consultation on proposed new licence fee structure
You are invited to take part in a consultation on the HTA’s proposed new licence fee structure. As engagement is one of the HTA’s founding principles, we would value your feedback – particularly to understand the effect an increase in the licence fee charge will have on your establishment and sector.
For information about the proposed fee levels for your sector and details of how to respond to the consultation, please visit the consultations section of this website.
The closing date for consultation responses is Thursday 5 March 2009.
If you have any questions about the consultation process please contact Morounke Akingbola, Head of Resources: morounke.akingbola@hta.gov.uk
Codes of practice consultation
The consultation on our revised codes of practice has now closed. Seven of our codes of practice are being revised to reflect our experience of regulation and a new code on research has also been produced.
More than 4500 people visited the consultation page of our website during the consultation period. We received 172 consultation responses, across all the codes, a number of which were from umbrella organisations or professional groups:
- Consent (36 consultation responses)
- Donation of organs for transplantation (15)
- Post-mortem examination (26)
- Anatomical examination (8)
- Disposal of human tissue (33)
- Donation of allogenic bone marrow and peripheral blood stem cells for transplantation (7)
- Public display (13)
- Research (34)
We also held four consultation workshops in two different locations, which focused on the consent, post-mortem, disposal and research codes.
Thank you to everyone who responded to the consultation and took part in the workshops. Once the codes have been finalised they will be published on our website in 2009.
Website survey
Thank you to everybody who participated in the HTA website survey and interviews. We have received some extremely valuable feedback and this will help us to update and improve the website for everyone who uses it.
We are currently reviewing the comments received and planning the developments we will be making to the website. We will provide more information about our plans and the results from the survey in the February issue of our e-newsletter.
Events
DI training events – post-mortem and human application sectors
It is a condition of all HTA licences that the Designated Individual (DI) completes HTA training – either face to face or online – within 12 months of receiving a licence. We provide DIs with training via workshops and our DI e-learning course.
There will be two DI training events at the beginning of 2009 – one for the post-mortem sector on 28 January and one for the human application sector on 25 March. The venues for the training courses will be announced in January.
If you are a DI from one of these sectors and you have not yet undertaken training, we encourage you to either attend the appropriate training event or complete the e-learning course as soon as possible. DI training is a core component of good governance and is designed to support your understanding of the regulatory requirements of relevant legislation, associated Directions, codes of practice and licensing standards. The training events will be open to all DIs in these sectors, however the HTA will give priority to DIs who have not been trained within 12 months of receiving a licence. Invitations will be issued shortly.
Public Authority meeting
The HTA holds two Authority meetings in public each year, one of which is held outside London. The public Authority meetings are an opportunity for members of the public and key stakeholders to observe the Authority discussing its business.
The next public Authority meeting will be held in Manchester on Tuesday 17 March 2009. You will be able to register for the meeting on our website from January. We will also provide more information about the meeting in the next issue of our e-newsletter in February.
Relevant material
The Human Tissue Act 2004 (HT Act) refers to ‘relevant material’ for the purpose of consent requirements and licensing by the HTA. We have now published revised guidance on the definition of relevant material. This guidance expands on the previous policy framework and includes information on the classification of specific materials under the HT Act.
Read the revised guidance on relevant material.
We will also be reviewing the definition of relevant material for the human application sector, and will provide more information in future issues of the e-newsletter.
Hampton Implementation Review
In striving to be a model, modern regulator, the HTA applies the principles of best regulatory practice which are enshrined within our primary legislation. The HTA has built a firm regulatory foundation based on these principles which ensure our regulatory activities are:
- transparent
- accountable
- proportionate
- consistent
- targeted only at cases in which action is needed
We announced in the June issue of our e-newsletter that the HTA was identified as one of three health regulators to receive a Hampton Implementation Review in 2008/09. The HTA’s inspection took place between 3 and 5 December. We will provide information about the feedback from the inspection in a future issue of the e-newsletter.
Information for the human application sector
Annual activity data
We will shortly be contacting all establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 to request your annual activity data. This data covers the period January to December 2008. This year, we are asking establishments to supply the information in pre-designed templates which will help you with the submission process. These templates will be emailed directly to all relevant DIs.
The completed annual activity data must be submitted to us at the end of January 2009. We would welcome your feedback on the pre-designed templates that we have produced, as this will help us to improve the data collection process in future years.
For further information please contact Emyr Harries, Regulation Manager: emyr.harries@hta.gov.uk or 020 7211 3441.
Human application sector workshop
On 11 November, we held a workshop which brought together people working at commercial and public sector establishments in the human application sector. The day focused on two areas of regulation: Developing Regulatory Methods (DRM) and Serious Adverse Events and Adverse Reactions (SAEARS).
The DRM session involved group discussions on renewing HTA licences. The SAEARS session involved group work with the EU matrix for reporting and recording adverse events and reactions.
Download the summary reports for the workshop.
Advanced Therapy Medicinal Product (ATMP) Regulation
In March 2008 we issued a joint statement with the Medicines and Healthcare products Regulatory Agency (MHRA) on the relationship between the Advanced Therapy Medicinal Product (ATMP) Regulation 2007 and the Human Tissue (Quality and Safety for Human Application) Regulations 2007. The statement aims to clarify when treatments involving tissues and cells are regulated by the MHRA, and when they are regulated by the HTA.
We are currently developing a series of frequently asked questions on the ATMP Regulation to provide more information on this area. These will be available shortly in the FAQs section of this website. Regulatory route map for clinical application of stem cells
The Department of Health and the Gene Therapy Advisory Committee (which now has additional responsibility in stem cell research) are talking to the HTA and other regulators to help develop a route map for clinical application of stem cells. The stem cell community will be engaged as the project develops.
Unproven stem cell treatments
On 4 December the Department of Health issued a warning about international schemes which offer patients unproven stem cell treatments, e.g. to treat Multiple Sclerosis and Parkinson's Disease. The Department of Health website provides more information about this warning and gives advice for any patients who are considering taking part in this type of stem cell trial.
ALLOMATRIX Products
The text below is provided for information purposes only.
The European Commission have identified that certain products distributed in Europe by Wright Medical Technology Inc. may not comply with the requirements of European Union Commission Directive 2006/17/EC regarding donor selection criteria.
Wright Medical Technology Inc. placed the products ALLOMATRIX Graft, IGNITE Injectable Graft & OSTEOSET II DBM on temporary hold in the UK and other European countries while they carried out documented risk assessments. Wright Medical Technology Inc. communicated this product hold information to its UK customers on 28 October 2008 and the products were taken off hold in the UK on 14 November 2008.
The HTA does not currently license establishments storing or distributing acellular products, but we have been in close communication with the European Commission and Wright Medical Technology Inc on this issue. For more information please contact Wright Medical Technology Inc.Information for the research sector
Research evaluation project
One of the HTA’s key strategic aims is that we do not hold up tissue-based research. In addition, one of the objectives in our 2008/09 Business Plan is to carry out an evaluation of the impact of human tissue legislation on the research community.
For this reason we are planning to work with an external consultancy company to evaluate the views of researchers working with human tissue. We will also be reviewing any existing knowledge or previous work that has been completed in this area.
If you work in the research sector, we will be contacting you to invite you to take part in the evaluation. We would very much appreciate your contribution to this project. More information will be provided in future issues of the e-newsletter.
Information for the anatomy sector
Anatomy forms
We mentioned in the June e-newsletter, that we are currently undertaking a review of the information we collect to ensure we only gather information that is necessary for our regulatory activities. As part of this review, the HTA (A) forms and the Anatomy Online Submission System (AOSS) have now been removed from our website as these are no longer necessary.
Anatomy schools do not need to notify the HTA of cadaver / body receipt and disposal activity, although DIs are advised to develop internal systems for ensuring the traceability of bodies and body parts. This may include implementing standard operating procedures (SOPs), forms or registers as well as keeping written agreements with funeral directors and transport companies.
The model consent forms and model loan forms remain on the HTA website and have been updated following feedback from staff working at anatomy establishments. Download the updated model forms.
Information for the post-mortem sector
Inspection of mortuaries by the HTA
It has been brought to our attention by the mortuary manager of one of our licensed establishments, that there is an individual attempting to access mortuaries by claiming that he is an HTA inspector. HTA inspectors visit mortuaries when undertaking a routine scheduled inspection or occasionally when undertaking an unannounced inspection. At all times when visiting establishments, HTA staff carry with them identification provided by the HTA. If you are not expecting a visit by an HTA team, please ask to see proof of identity before allowing access. Please remind your staff to be vigilant and contact the Regulation Directorate at the HTA on 020 7211 3400 if you have any concerns.
Information for the organ and bone marrow transplant sector
Organ donations
From 1 April 2008 to 22 November 2008, 692 reports from Independent Assessors (IAs) were submitted to the HTA, 687 of which were approved. Two cases are currently awaiting more information before they can be adequately assessed, and three reports are to be referred to panels for decision. Since 1 April, 17 cases have been referred to a panel of HTA members for a decision.
Bone marrow transplants
From 1 April 2008 to 24 November 2008, 40 reports from Accredited Assessors (AAs) were submitted to the HTA, all of which have been approved.
Independent Assessor conference
Our second IA conference took place on 5 November and was attended by IAs and transplant unit members. The day provided an opportunity for networking and sharing experiences about the HTA’s transplant approval process. We would like to thank everyone who attended for helping make it such an interesting and informative day.
Ann Keen MP, Parliamentary Under Secretary for Health Services, provided a keynote speech at the start of the conference. You can read a quote from her speech in the newsroom section of this website.
Download the presentations from the conference.Transplant approvals over Christmas
Our transplant approvals team will be considering submissions from IAs during the Christmas period, but we recommend that only urgent cases are submitted at this time.
The out-of-hours service for emergency organ transplants (usually liver failure) will operate over the whole Christmas period. Details of this process can be found in the December issue of the IA bulletin.
Recent media stories about human tissue
Organ Donation Taskforce
In November, we issued a media release in response to the Organ Donation Taskforce report on presumed consent. The Chair of the HTA, Shirley Harrison, is a member of the Taskforce which has concluded that the UK should not move to an opt-out system where consent for the use of organs for transplants is presumed. Read the media release.
A letter from Adrian McNeil, Chief Executive of the HTA, was published in the Guardian on 21 November to correct an inaccuracy in an earlier Guardian article about the risk of organ donation by living donors.
Respectful interment of retained tissue samples, organs and fetuses from the University of Liverpool and Alder Hey NHS Trust
We responded to the announcement of a public information process for the respectful interment of retained tissue samples, organs and fetuses from the University of Liverpool and Alder Hey NHS Trust. We were quoted in the media, including the Liverpool Echo and Daily Mail.
Security of electronic information
In February 2008 the Department of Health established an Information Governance Assurance Programme (IGAP) to provide a consistent approach to the security of electronic information.
In response to this programme we have conducted a Data Protection assessment in line with the IGAP initiative. We will continue to introduce improvements to the way we store and share information to ensure that any potential risk of personal data loss is minimised.