Issue 25 - October 2010

Welcome to the October issue of the Human Tissue Authority’s e-newsletter. The e-newsletter is the main way we communicate developments in regulatory policy and is essential reading if you work in one of the sectors we regulate or your work links to us. We now have more than 6,000 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 an update on the arm'-length bodies review, an announcement on our fees for 2011 / 2012, our plans to publish individual inspection reports online, information on our recent public Authority meeting and details of the 2009-10 summary report of performance against our standards for licensed sectors. You can also find out about our contribution to the Nuffield consultation on Bioethics and the use of human bodies in medicine and research.

For the human application sector (using tissue and cells for patient treatment) we provide an update on our forthcoming conference.

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

Corporate news

Arm’s-length bodies review

Following publication of the Government’s ‘Liberating the NHS: Report of the arm’s-length bodies review’ on 26 July, it is business as usual for the HTA, and we continue to liaise with the Department of Health on the best way to transfer our functions by 2013. The HTA Board has also discussed the review and is concerned to ensure that public and professional confidence in regulation and the requirements for consent are maintained during the transition. The HTA executive has had meetings with other regulators including the Care Quality Commission (CQC), Human Fertilisation and Embryology Authority (HFEA) and the Medicines and Healthcare Regulatory Agency (MHRA).

The Senior Management Team at the HTA has been working to look at our functions and to evaluate a number of options including transfer of individual HTA functions to a range of organisations as suggested by the review.  However, as some of the review proposals were tentative or dependent on other developments, we have also looked at other options including keeping the HTA’s regulatory functions together but moving them as a coherent entity to the Care Quality Commission while sharing support functions.

We will keep stakeholders regularly updated in the e-newsletter. If you missed our special edition e-newsletter on the arm's-length bodies review, you can still read it on our website.

2011 / 2012 fees announcement

The HTA has recently written to all licensed establishments to announce the new fee structure and fees for 2011/12. Fees have been reduced for all sectors, and for most establishments. They will be effective from 1 April 2011, the principle underlying the changes is that fees should relate as closely as possible to the effort needed from the HTA to regulate.

The HTA is making efficiencies which enable us to reduce the overall fees we charge across all sectors by 14%.

For further information about the new fee structure, including a breakdown of fee charges, visit our website.

Licence fee rebate

You may be aware that the HTA holds surpluses, arising from the collection of licence fees from April 2006 to the present time. These have arisen because more establishments than expected have paid licence fees and because of the steps the HTA has taken to reduce costs. 

In July 2009, the Authority agreed that we should rebate unused licence fees and HTA staff began discussions with the Department of Health and HM Treasury. Making a rebate of this sort has required Treasury approval, which we received in September 2010.

We will repay surplus licence fees generated in the financial years from 2006/07 to 2009/10 inclusive (a total of £1.1m) to the establishments that paid licence fees in those years. We aim to notify each establishment later this month of the total amount owing to them, and make arrangements for repayment.  Refunds will be broadly proportionate to the fees paid. We regret our assumptions resulted in surplus fees being collected but we are glad to be able to provide refunds now.

More information is on our website.

Summary report of performance against HTA standards for licensed sectors 2009-10

For the past two business years, the HTA has published separate reports for each of our licensed sectors, showing the extent to which establishments have met HTA quality standards for protecting the public and building confidence in the regulation of the storage and use of human tissue, where areas of difficulty have been and providing advice and guidance on good practice. For the 2009/10 business year, we will publish a single report, which will feed back on all five sectors. The report will present findings of inspections and other regulatory activities which the HTA has undertaken. This report will be published on our website in early 2011.

This report will contain brief summaries of performance information for the public display, anatomy and research sectors, due to the small number of licensable activities they undertake and their relatively good performance against standards. The human application and post mortem sectors will comprise larger, more comprehensive, sections of the document due to the large number of establishments in these sectors and range of licensed activities they undertake.

For the post mortem sector, a separate report will be published in April 2011,  containing a summary of the establishment self-assessments submitted earlier this year, and the audits of retained tissue (see post mortem section below).

Publication of inspection reports online

After a site-visit inspection, the HTA documents its findings in an inspection report. This report is shared with the Designated Individual (DI) and Licence Holder (LH). We may also share copies of finalised inspection reports when they are requested under the Freedom of Information Act 2005 (FOI Act).
 
Publishing our inspection reports helps us adhere to good regulation principles. In reviewing our regulatory processes and seeking to make improvements, we have assessed the benefits of making inspection reports publicly available via our website. We believe that publishing inspection reports will enable the HTA to be more transparent about the regulatory action we take following an inspection and to be more accountable to our stakeholders. In addition, inspection reports contain valuable information about how establishments have met quality standards needed to protect public confidence as well as areas that they have found challenging, and we hope that their publication will help us to share learning among licensed establishments about how to improve the quality of services.

The HTA will begin publishing inspection reports on our website from January 2011 for inspection site-visits which have taken place from 1 November 2010.

Some information (such as information which identifies individual members of staff) will be edited in accordance with our responsibilities under the FOI Act 2005. However, we will aim to publish as much of the report as possible. You can read the HTA paper on this initiative on our website in the September Public Authority meeting papers.

If you have any questions please contact Teena Chowdhury, Regulation Manager, on 020 7211 3427 or teena.chowdhury@hta.gov.uk

Licensing and inspections update

Since the HTA began licensing in 2006, we have completed 725 desk-based inspections and 499 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.

HTA office relocation

The HTA is moving from our current location in Finlaison House, Furnival Street to 151 Buckingham Palace Road in December 2010. The HTA will be located with the Medicines and Healthcare products Regulatory Agency, the Health Protection Agency and NHS Litigation Authority. More information will be available on our website shortly.

Website update

In February we reported on the work we were doing to Review the content of all of the pages on the site to reflect our latest advice and guidance. We have now completed this Review. We know how much our stakeholders value the website for downloading publications and accessing advice and guidance, and we have worked across the organisation to create new pages which reflect the range of enquiries which we receive.

As one of our key communications channels, the website will continue to be updated to reflect stakeholder needs. If you have any ideas about what you would like to see on our website, please contact us via email: enquiries@hta.gov.uk

Human application conference, 21 October

The HTA human application conference on 21 October will be of particular interest to DIs and others working in the sector. Further details about the day, can be found on our website. Registration has closed, though there is a reserve list. If you are interested in attending, please contact enquiries@hta.gov.uk. We will be publishing presentations from the event on the website.

Public Authority meeting, 28 September

The HTA currently holds two Authority meetings in public every year. These events provide an opportunity for members of the public to observe the Authority as it discusses its business and ask questions. The last public meeting was held on Tuesday 28 September.  You can download the papers for the meeting from our website.

External event: Sharing human tissue conference, 15 September

The HTA Chair, Baroness Diana Warwick recently spoke at the Medical Research Council and onCore UK conference entitled 'Sharing Human Tissue: New opportunities, new horizons', alongside former Authority Member Professor James Ironside. Many Designated Individuals (DIs) attended.  Further information about the event can be found on our website.

Nuffield consultation

The HTA has submitted written evidence to the Nuffield Council on Bioethics consultation on the use of human bodies in medicine and research, which closed on 13 July.

Our submission outlined our role in transplantation including living and deceased donation and our position on consent and payment. You can read our full response on our website. The responses are being considered by the Working Party.

Information for the human application sector

Regulatory alert 002/2010

On 7 September we issued a notice for DIs in the human application sector regarding the incidence of West Nile Virus in Greek Macedonia, Northern Greece and its implications. To read the alert in full, visit our website.

Consolidation of HTA Directions 001/2006, 002/2007, 004/2007

The HTA is updating and consolidating Directions 001/2006, 002/2007 and 004/2007 for the human application sector. They will be published on the website shortly. There are three areas of note:

• clearer guidance will be issued in relation to third parties and third party agreements
• the Directions will contain a clarification of the donor testing requirements currently set out in Directions 001/2006 Annex B
• the HTA will implement new serious adverse events (SAE) and reaction  (SAR) reporting timelines (see below)

New timelines for the reporting of serious adverse events (SAEs) and serious adverse reactions (SARs)

The HTA is drafting revised Directions to include new timelines for the reporting of SAEs and SARs. Under the new reporting requirement, initial notifications should be submitted to the HTA within 24hrs of being identified. This includes weekends and public holidays. Follow-up reports should be submitted within 90 days.

Although the reporting times of SAEs and SARs have reduced since 2007, we have found that establishments are still often delaying reporting to us by weeks or even months. The HTA considers it essential that the current time gap between the discovery of an SAE / SAR and reporting is substantially shortened to enable us to fulfil our duties of alerting all relevant establishments, bodies and authorities in cases where they  raise health concerns that have wider public health implications and which reach beyond the establishment immediately affected.

These timelines will bring the HTA in line with other healthcare regulators with vigilance and surveillance systems and enable us to effectively discharge our duties and fulfil our role in protecting public health under the remit of the European Union Tissue and Cells Directives and the Q & S Regulations. This new requirement will come into force when the revised Directions are issued.

Clarification on activities related to cord blood

The HTA is producing a guidance document, to provide clarification on activities related to cord blood undertaken by licensed establishments. A workshop to discuss the content, held recently at the HTA, included representatives from cord blood banks in the public and private sectors, phlebotomy companies and the Royal College of Midwives. Publication of the document will be communicated to licensed establishments, and it will be made available in PDF format on our website.

Information for the research sector

Update on the HTA’s contribution to the Academy of Medical Sciences’ Review of the regulation and governance of medical research

Many of you will know that the Academy of Medical Sciences (AMS) are Reviewing the regulation of the medical research in the UK and the Department of Health has stated that the Review’s findings will influence the plans they have for the HTA’s human tissue research functions. As we reported in our last e-newsletter, we submitted a response to the original call for evidence. Following this, the AMS issued a second call for evidence on the proposals of relevance to the regulation of medical research contained within the Department of Health’s report on Arm’s Length Bodies.

In particular, it focused on:

• the merits of placing responsibility for different aspects of medical research regulation within a ‘single research regulator’
•  the future of the National Research Ethics Service and reorganisation of the research regulatory activities of the HTA and the Human Fertilisation and Embryology Authority

Our response to the second call for evidence is available on our website.

Information for the post mortem sector

General Directions – update (30 September 2010)

On 30 April 2010, we issued two sets of general directions to all DIs in the post mortem sector. The first set of Directions requires an annual performance report against core HTA standards to be submitted to the HTA. The first self-assessment had to be submitted to the HTA by 30 June 2010. The second set of Directions required an audit of relevant material taken from the deceased that is stored at HTA-licensed establishments in this sector.

The primary aim of the audit is to assure the HTA that post mortem tissue kept for research and other purposes required under human tissue legislation is given with consent so that the public can be confident that the regulator is doing its job in ensuring that people’s wishes are respected.

The information will:

• enable the HTA to provide tailored advice and guidance to individual establishments on tissue retention;
• identify establishments that require support in reviewing their systems governing consent, traceability and disposal, in order to achieve full compliance with HTA standards;
• inform the advice and guidance provided to the PM sector as a whole on common areas of difficulty;
• provide information to the HTA on the issues facing post-mortem sector establishments to inform the continued development of HTA policy affecting the sector.

The deadline for the second set of Directions was 30 September. If you have not already completed an inventory of whole organs / wet tissues and an audit of tissue from the deceased which is stored on the premises and submitted results to the HTA, please contact the HTA via enquiries@hta.gov.uk

Information on how to submit your audit results summary can be found on our website.

Performance reporting

The HTA would like to take this opportunity to thank all licensed establishments in the post mortem sector for updates submitted on how they are meeting our standards to protect public confidence.

As mentioned above, General Directions issued in April this year required every post mortem establishment to submit an up-to-date self assessment of performance against HTA standards.  We are pleased to report that we received 98% of submissions by the deadline of 30 June, with a few extensions being granted on a case-by-case basis.

The information from responses to both sets of directions will help us identify where establishments are struggling to meet quality standards and require additional support.  In addition, the information will help inform our inspection scheduling over the next business year, and the 2009-10 summary report of performance against HTA standards.

Licensing of the removal of relevant material from deceased children

Through inspections and enquiries, the HTA has identified cases where removal of tissue from the deceased, in particular infants and children, may take place in an area of the establishment not covered by the HTA licence.

For example:

• in cases of unexpected paediatric deaths as outlined in Working together to safeguard children (2010), removal may take place in A&E departments or on paediatric wards
• cytogenetics specimens may be taken on maternity wards in cases where there have been multiple pregnancy losses; where the gestational age is 24 weeks or greater this falls within the HTA’s remit
• toxicology samples may be taken in A&E departments in adult cases

Removal of relevant material from the deceased for use in scheduled purposes must be carried out on HTA-licensed premises. Post mortem establishments wishing to extend their licensed premises to cover removal outside of the mortuary must make a written request to the HTA by email (licensing.enquiries@hta.gov.uk) or post (The Human Tissue Authority, Finlaison House, 15-17 Furnival Street, London, EC4A 1AB). Designated Individuals must be prepared to accept responsibility for this activity. Advice and guidance will be provided on request. For more information visit our website.

Information for the organ and bone marrow transplant sector

Organ donations from living people

Between 6 April 2010 and 1 September 2010, the HTA approved 494 reports from Independent Assessors (IAs).

44 of these reports were referred to a panel of HTA Members for decision. A decision on a transplant must be made by an HTA panel if the donor is a child, if the donor is an adult who lacks capacity to consent to removal of an organ or part organ and  in all cases of paired and pooled and altruistic non-directed donation.

Bone marrow donations from children and adults who lack capacity to consent

Between 6 April 2010 and 1 September 2010, The HTA approved 27 reports from Accredited Assessors (AAs).

Recent media stories about human tissue

In July we contributed to a feature on pooled transplant which was published in Real People magazine. We also contributed to an article in the American journal Science titled the Legacy Plan. Our Chair Baroness Diana Warwick was interviewed in Research Fortnight. In September our regulatory role was mentioned in The Times’ coverage of stem cell tourism. We also drafted an article for Blood and Transplant Matters about what the HTA has achieved and our future mission. We issued a media release about an inspection of Cardiff’s University of Hospital Wales Llandough (University Hospital Llandough) which demonstrated that its post mortem facilities are an example of best practice. We also issued a media release about our 2011/12 fees model.

Previous e-newsletters

Previous copies of the HTA's e-newsletter are available in the news and events section of our website.

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