Issue 10 April 2008
Welcome to the April issue of the Human Tissue Authority’s e-newsletter which provides updates for all the sectors we regulate.
This issue includes reports from two major recent events – the public Authority meeting in Cardiff and the conference for professionals working with human tissues and cells for patient treatment.
In this issue we also provide guidance on the link between the Advanced Therapy Medicinal Product Regulations that are implemented by the MHRA and the Quality and Safety Regulations that the HTA implement. We also provide an update for establishments that procure human tissues and cells.
For the transplant community, we provide an update on transplant approvals and a link to our Select Committee evidence 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
Recent media stories about human tissue
The HTA has issued a statement about directed donation of organs after death.
Following a BBC 2 Horizon programme on 17 March entitled “How much is your body worth?” articles in the press discussed whole body donation and mentioned the Human Tissue Act 2004. Find out more about our role in body donation and the regulation of anatomy schools.
Body Worlds 4, Gunther von Hagens' exhibition at Manchester’s Museum of Science and Industry, was covered widely in the regional media. The HTA has inspected and licensed this establishment for public display.
Public Authority meeting – 18 March 2008
Our first public Authority meeting of 2008 was held in Cardiff on 18 March. At the meeting the Authority members discussed and approved the HTA’s Business Plan for 2008/09 and three draft Codes of Practice. The Codes will be issued for public consultation during the summer.
Thirty six representatives from a wide variety of organisations, including Designated Individuals (DIs) from licensed establishments, representatives from professional bodies, and members of the public observed the meeting. Feedback from the event was overwhelmingly positive. Find out further information about the meeting.
Our next public Authority meeting will take place on 18 September 2008 in London. Details will be available on the future events section of our website nearer the time.
Licensing and inspections update
Designated Individual training
It is a standard condition of having a licence that the DI completes HTA DI training within 12 months of receipt of a licence. The purpose of the training is to ensure that DIs receive practical advice and guidance on understanding and fulfilling their statutory duties.
If you are a DI who has not yet completed training, or you would like to refresh your knowledge, you can complete our e-learning course for DIs. Although the course is primarily aimed at DIs, anyone can access it and so it may also be useful for other people working at a licensed establishment.
We will also continue to run training events for DIs from time-to-time and when there is demand. Details of these events will be posted in due course.
Inspections update
Since the HTA began licensing in 2006, we have completed 539 phase one (desk-based) inspections and 133 phase two (site-visit) inspections across all five of our licensed sectors. Inspections are usually scheduled according to assessed risk; however they may also be scheduled randomly or on a reactive basis following receipt of information. Read more information about inspections.
Advanced Therapy Medicinal Product Regulations
The HTA has issued a joint statement with the Medicines and Healthcare products Regulatory Agency (MHRA) on the relationship between the Advanced Therapy Medicinal Product (ATMP) Regulations 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. You can read the statement here.
Information for the human application sector
HTA conference – Regulating tissues and cells for human application: the past, the present, the future
On 25 March we held a conference for all establishments working with human tissues and cells for patient treatment (human application). 165 people attended the event, including representatives from HTA licensed establishments and tissue banks in Europe.
The day was made up of a series of presentations and breakout seminars, which considered past, present and future issues of relevance to this diverse sector. You can download the presentations and see photos from the event on our website.
Thank you to all the speakers and everyone who attended for making the conference such a success.
If you attended the conference but did not have time to complete your evaluation form, you can download this from our website and email it back to us.
Compliance with HTA Directions 002/2007 paragraph 47 (i)
Establishments that are licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 are required to complete an HTA self-assessment form as part of the quality review process.
This ensures that all human application establishments are aware of the new and additional standards that must be met following the transposition of the EU Tissues and Cells Directives into UK law via the Regulations. It also means that establishments can identify areas of practice that require development in order to meet the new standards.
The HTA may also request an up-to-date report of compliance against standards prior to an inspection, to ensure that inspections continue to be targeted and focused.
Please note that establishments are not expected to submit the self-assessment form to the HTA unless requested to do so. A PDF and Word version of the self-assessment form are available at this link.
Procurement organisations
The HTA held two workshops for procurement organisations – one for cord blood procurers (12 December 2007) and one for those procuring other tissues or cells (16 January 2008). The report from the first workshop is available on our website and the report from the second workshop will be available soon.
Following these workshops we have been working through the complex issues raised in relation to procurement and the Human Tissue (Quality and Safety for Human Application) Regulations 2007. We will shortly be writing to all establishments in the human application sector and to other organisations that procure human tissues and cells, with further information about these issues.
Regulatory alert 002/2008
On 14 April, the HTA issued regulatory alert 002/2008 to all establishments licensed for human application. Read the regulatory alert.
Information for the post mortem sector
The Human Tissue (Quality and Safety for Human Application) Regulations make procurement of tissue for human application an activity that can only be undertaken under a licence from the HTA or a third party agreement with a licensed establishment. This requirement has implications for mortuaries.
If retrieval of cadaveric tissue takes place in your mortuary, either by your own staff or by external retrieval teams, please check the guidance which will be available shortly.
Information for the anatomy sector
The HTA has begun a review of all data that we collect, to ensure that we only gather and use data that is necessary for our regulatory activities.
We will be reviewing the data collected from the anatomy sector first, because we currently gather most data from this sector and have received some feedback from establishments about the Anatomy Online Submission System (AOSS).
As part of this review we are looking at the AOSS (which is used to record body donation and disposal), and the HTA forms used by the anatomy sector. Once we have completed the review, we will update the anatomy schools pages of this website.
If you have any questions about the review, please contact Kristi Adams, Head of Regulation, kristi.adams@hta.gov.uk or 020 7211 3413.
Information for the organ and bone marrow transplant sectors
Organ donations
From 1 April 2007 to 26 March 2008, 987 reports from Independent Assessors (IAs) were submitted to the HTA, and 983 were approved. We are currently awaiting more information on one case before it can be adequately assessed; three other cases are with HTA panels for decision. Since 1 April 2007, 25 cases have been referred to a panel of HTA members for a decision. More information can be found in our Independent Assessors bulletin.
Bone marrow transplants
From 1 April 2007 to 26 March 2008, 65 reports from Accredited Assessors (AAs) were submitted to the HTA, all of which have been approved. More information can be found in our Accredited Assessors bulletin.
HTA evidence to the Select Committee on the EU inquiry into organ donation
Peter Lemmey, Director of Policy at the HTA, gave evidence to the Select Committee on the European Union’s inquiry into ‘Communication on organ donation and transplantation: policy actions at EU level’ on 13 March.
A full transcript of this evidence is available from the Select Committee’s website (follow this link and then select the link to corrected oral evidence).