Issue 16 - April 2009
Welcome to the April 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 4500 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 our licence fee structure for 2009/10, and reports from our recent public Authority meeting in Manchester and our Designated Individual training event in Birmingham.
You can also read about the development of a regulatory route map for stem cell research and manufacture, which has been produced jointly by the Department of Health and UK regulators including the HTA.
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 the future, please contact us at enquiries@hta.gov.uk.
Consultations
Licence fee consultation
We are very grateful to all who responded to the licence fee consultation, which ended on 5 March. The responses came from individuals, professional and representative bodies, and organisations holding a number of licences.
At the public Authority meeting on 17 March, the HTA Board considered the responses very seriously. They agreed to a reduction in licence fees for satellite sites; and, for the human application sector, not to charge any fee for third party agreements in the 2009/10 financial year.
We fully understand that this increase in fees comes at a difficult time, especially for smaller organisations. That is why we have done everything we can to keep licence fees to a minimum. These include applying the lightest possible touch when implementing complex legislation and introducing streamlined systems and processes.
The human application sector has seen a bigger increase than the others. This is because the European legislation that applies to this sector has grown in complexity and volume; and it allows us very little flexibility in how we regulate.
As a result of the consultation, the HTA has decided to look again at the alternatives to charging a flat fee within each sector.
The invitations to respond to the consultation set out in some detail the rationale for the fee changes. A further rationale responding to the comments made during the consultation will be issued within two months.
We wrote to all Designated Individuals and Licence Holders on 27 March to confirm the licence fees for 2009/10. The final fee structure is available on this website.
Invoices for 2009/10 will be issued as follows:
- Human application establishments licensed before 5 July 2007 – April
- Human application establishments licensed from 5 July 2007 and procurement organisations – July
- Anatomy, research, post mortem and public display establishments – September
Impact of human tissue legislation and regulation on research
Thank you to everyone who took part in our project to evaluate the impact of human tissue legislation and regulation on research. The telephone and online interviews have now been completed, and the external company that we are working with on the project – Opinion Leader – are currently analysing the results. The results will be announced in due course.
Events
Upcoming events
Report-back event, 14 July 2009
Our annual report-back event will take place in London on 14 July. More information about the event and a registration form will be provided on our website in due course. If you would like us to let you know when the registration form becomes available, please email serena.box@hta.gov.uk
Past events
Public Authority meeting, Manchester
Our public Authority meeting took place in Manchester on 17 March. The meeting provided an opportunity for our stakeholders in Manchester and the surrounding areas to observe the Authority discussing its business. The meeting was attended by 40 people, including members of the public and professionals.
The main agenda items discussed at the meeting were our revised codes of practice and new licence fee structure. The meeting papers are available to download from this website.
Designated Individual training for the human application sector, Birmingham
On 25 March we held a training session for 80 Designated Individuals (DIs) from the human application sector. The event in Birmingham included the role of the DI and Licence Holder, serious adverse event and reaction reporting, quality management systems, and the HTA’s inspection processes. Presentations are available in the past events section.
Licensing and inspections
Move from fixed term to continuous licences
As explained in our last e-newsletter, following feedback from the licensed sectors we have decided to change from a fixed-term licensing system to a continuous licensing system. The continuous licensing system will be supported by a new sector-specific compliance monitoring framework. We have now written to all licensed establishments to let them know about this change. DIs and licensed establishments do not need to take any action as a result of the change.
Inspections update
Since the HTA began licensing in 2006, we have completed 659 phase one (desk-based) inspections and 240 phase two (site-visit) inspections across our five 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.
Information for the human application sector
Recent information about potential vCJD transmission to a haemophiliac patient who received plasma products.
This website contains information and advice to remind human application establishments on the requirements for donor selection from patients treated in the 1990s with UK-sourced clotting factors.
Update on HTA regulatory alert 003/2008 on West Nile Virus
We previously issued a regulatory alert (003/2008) to inform human application establishments of an outbreak of West Nile Virus in Italy. With the decrease of mosquito activity in the winter months, the risk of human exposure to mosquito bites is very low and precautionary measures have been reduced by the Italian authorities. More information about this issue is available on this website.
Regulatory route map for stem cells
The HTA has participated in the development of the first version of an interim UK regulatory route map for stem cell research and manufacture. The route map has been produced as a reference tool for those who wish to develop a programme of stem cell research and manufacture, ultimately leading to clinical application. The map has been developed by the Department of Health with the support of the Gene Therapy Advisory Committee, regulatory bodies, the Medical Research Council, and stem cell researchers.
A link to the route map is available. Feedback on the route map can be sent to gtac@dh.gsi.gov.uk
A more detailed, user-friendly, web-based version of the route map is currently being developed and will be available by the end of 2009.
Distribution, import and export
We have developed new guidance for organisations in the human application sector on the distribution, import and export of tissues and cells under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 and HTA Directions. This guidance is in the form of frequently asked questions.
Information for the anatomy sector
Cremation forms
The Cremation Regulations 2008 introduced amended forms to support the cremation process. This change affects anatomy establishments. The old Form A has been replaced by the form Cremation 1 which is available from the Ministry of Justice (MoJ) website.
For body donations that pre-date the new form, the MoJ has suggested that the Cremation 1 form is completed by the Designated Individual and submitted alongside Form A which will have been completed by the donor's family. The ultimate decision to accept such an arrangement rests with the medical referee at the crematorium; however, the MoJ does not foresee any problem with this approach.
For more information about the Cremation Regulations 2008, contact Brian Patterson at the MoJ on 020 3334 6404.
Staff training
Staff at anatomy establishments may have read the last issue (No 116) of the newsletter produced by the Institute of Anatomical Sciences (IAS), which included an article titled 'New Qualification Offered by the Institute'. This article incorrectly mentioned that qualifications offered by the IAS are now recognised by the HTA.
Whilst we encourage staff training and development, we do not recognise or endorse particular training courses or qualifications. In addition, we do not require establishments to provide set training courses for anatomy staff, since the training provided should reflect the needs of staff.
For more information on this issue, contact Kristi Adams, Head of Regulation at the HTA: kristi.adams@hta.gov.uk or 020 7211 3413.
Information for the organ and bone marrow transplant sector
Organ donations from living people
From 1 April 2008 to 31 March 2009, 1060 reports from Independent Assessors (IAs) were submitted to the HTA, 1050 of which were approved. One case was not approved, one case is currently awaiting more information before it can be adequately assessed, and eight reports are currently with panels for decision. Since 1 April 2008, 40 cases have been referred to a panel of HTA members for a decision.
Bone marrow donations from children and incapacitated adults
From 1 April 2008 to 31 March 2009, 57 reports from Accredited Assessors (AAs) were submitted to the HTA, all of which have been approved.
Recent media stories about human tissue
An article on brain donation appeared in the Daily Express on 3 March. David King, who was quoted in the HTA Annual Review 2007/08, spoke about the decision taken by his wife to donate her brain for research after death. The article discusses the importance of brain donation for medical research and explains the HTA’s role in regulating this area.
An article about the revised HTA policy on regulation of acellular material featured in BMA News on 20 February. The BMA welcomed the revised policy saying that “a further tightening up of the safety aspects is a welcome reassurance.” The BMA article is available to download in the media releases section.
New HTA website
Please look out for our new website which we will be launching at the beginning of June. Thank you to everyone who has contributed to the new website by taking part in user testing – your feedback and comments have been much appreciated and will help to improve the site for all who use it.