Issue 29 June 2011

Welcome to the June 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 ours. We now have more than 7,000 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 a reminder to establishments about the 30 June deadline for submitting their self-assessments. It also includes news about our review of the year event next month which will be combined with our public Authority meeting. There are frequently asked questions about our new role as Competent Authority for the European Union Organ Donation Directive (EUODD) as well as an update on the workshop we held with NHS Blood and Transplant.

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 update

In July 2010, the Government published the arm’s-length bodies (ALB) review. It recognised the essential nature of the HTA’s functions, and the importance of our work continuing, but proposed these functions be transferred to other bodies.

We believe the best way to maintain focus and ensure public and professional confidence in the safe and ethical use of tissues and organs, with proper consent, is to keep all our functions together. The signs from Government are positive as this is now their preferred solution, though there are still some issues to settle in research. We will continue to support decision-making to help ensure the best possible outcome. We expect any transfer will happen over the lifetime of this Parliament, most likely in 2014. In the meantime it is business as usual.

Public Bodies Bill

The Public Bodies Bill (PBB) continues its passage through Parliament. Lord Howe wrote to Baroness Thornton in response to the debate on 28 March at the Lords report stage. In the letter he noted the Government's intention to consult in late summer on options as to where particular functions of the HTA and Human Fertilisation and Embryology Authority (HFEA) are best transferred. Having taken into account the strength of feeling expressed during the debates, he also noted that the preferred option is to transfer the HTA and HFEA’s functions to the Care Quality Commission (CQC), with the exception of certain research-related functions.

Lord Howe said that, at present, the research functions they propose to transfer to the new health research regulatory agency (now referred to as the Health Research Authority) are all HFEA functions – they envisage their licensing of embryo research will transfer. None relate to the HTA. Lord Howe said they will consider our research-related functions in discussion with us.

In the third reading of the Bill, Lord Howe said that the transfer of functions would occur in a single instance rather than having to go through a series of changes. He also said that the Government would undertake a full impact assessment.

Lord Howe said he accepted the case for keeping the HTA functions together – though the consultation would have other options as well as this Government’s preferred option.

The Health Research Authority will be set up as a special Health Authority this year with the National Research Ethics Service as its core. The aim is to establish the agency as a legal entity in its own right through primary legislation in the second session of this Parliament.

Overall, whilst not a cast iron guarantee, these developments are promising for our ambition of keeping all our functions, including research, together. The Authority does not believe the proposal to transfer the HTA’s research functions to the new regulator would achieve simplification, reduce burdens or achieve savings.

As the Bill continues through Parliament, the HTA will monitor amendments. We will keep stakeholders regularly updated in our e-newsletter. For more information, visit our ALB webpage or read the papers from our last Authority meeting.

Developments with the CQC and Department of Health

The HTA’s Senior Management Team has met representatives from the Care Quality Commission (CQC) to discuss potential synergies and develop plans for working together in these areas. The aim is to work on a tripartite basis with the HFEA.

A strategic partnership agreement, which will set out the principles of working together and clarify the separate governance and accountability arrangements until such a point as any transfer takes place, is being drawn up.

Public Authority meeting and review of the year, 26 July

This year the HTA will be combining a public Authority meeting with our annual review of the year. This event will be held on Tuesday 26 July at the Wellcome Collection conference centre in London.

In the morning a regular Authority meeting will take place in public and provide an opportunity to observe the Authority as it discusses its business. Once the formal agenda items have been discussed there will also be an opportunity to ask questions.

In the afternoon we will hold our review of the year. This is a key HTA event, during which we review our work over the past year and launch our 2010/11 Annual Review, which this year will be published online only. There will also be a presentation on our approach to regulation, and an update and Q&A session on the arm’s-length bodies review.

This will be followed by a debate on how, as relationships between potential donors and recipients become increasingly varied, the HTA can continue to ensure that living organ donation is something people enter into freely and without financial reward.

Speakers will present their perspective on the issue, followed by a discussion with the audience. The issues for debate will include whether the risk of reward is increased when the donor wants to decide who receives the organ and they have not met the recipient. These cases may include relationships formed on the internet, and between distant cousins. And, if the risk is greater, how we can ensure no reward is in fact involved.

You can download an agenda from our website. Details of speakers will be uploaded shortly.

If you would like to attend the event, registration is now open on our website and will close on 8 July. Registration is first-come-first served and we will automatically reserve your place.

Authority meeting, 24 May

The last HTA Authority meeting took place in London on Tuesday 24 May. The items discussed included the progress made with the implementation of the EU Organ Donation Directive, and a report on regulatory activity in the last quarter of 2010/11.

All meeting papers presented are available to download from the HTA meeting papers webpage.

European Union Organ Donation Directive Q&A and workshop

As we reported in our last e-newsletter, the Department of Health (DH) announced in March that the HTA would be the Competent Authority for England and Wales for the EU Organ Donation Directive (EUODD). We will also fulfil this role for Scotland and Northern Ireland.

On 21 April we published a list of frequently asked questions (FAQs) and supporting documents on the EUODD on our website and sent a link to key stakeholders. If you have any questions or comments on our FAQs, please contact enquiries@hta.gov.uk.

The implementation of this Directive will bring all EU countries up to the same high quality and safety standards. With better organs available in the EU, more UK citizens may benefit from the availability of suitable organs transferred from across Europe. We are developing a regulatory framework for implementation into legislation by August 2012.

On 19 May, the HTA and NHS Blood and Transplant jointly hosted a workshop on the implementation of the EUODD, attended by a cross section of the UK transplant community. Almost 100 delegates heard presentations on the proposals and the background to the Directive, delegates then worked in groups to examine our draft proposals for the licensing framework that will support implementation of the Directive in the UK.

Delegates were given the opportunity to discuss our proposals, including the detailed Directions. Thanks to all delegates who attended for their time and hard work throughout the day, and for their positive feedback. We want to be as light touch as possible while meeting the aims of the Directive and involving stakeholders so that we can build on what already exists in a sensible way.The workshop was the first of many opportunities for stakeholders to input into the regulatory framework for organ donation and transplantation. We will be formally consulting on the draft Directions between August and October, at the same time DH will consult on the Regulations that will transpose the EUODD into UK law. Further details on the consultation process will be available on our website in August.

General Directions for anatomy, public display and research sectors

In April we sent out General Directions to Designated Individuals in the anatomy, public display and research sectors which are designed to assure us that establishments continue to be suitable to be licensed to undertake activities under the Human Tissue Act 2004. We would like to remind establishments that the deadline for self-assessment form submission is Thursday 30 June. The Directions and supporting documentation are available on our website.

The Directions ask staff at establishments to check and confirm their licensing information; to undertake a self-assessment against our standards; and provide general information about activities.

Following assessment of the information provided, we will update establishments’ licensing records. The information from this exercise will inform our inspection programme and regulatory approaches to each sector. Having up-to-date records on our licensed establishments and how they are performing against our quality standards will increase our capacity to be an efficient regulator and help us to maintain public confidence in the regulation of human tissue. Where gaps in performance are identified, we can work with establishments to help them improve. We are grateful for responses received so far. If you have any questions please contact enquiries@hta.gov.uk.

The HTA’s social media

The HTA has launched Facebook and Twitter sites. You can ‘like’ the HTA by visiting our new Facebook page. We also have a Twitter page so please follow us. If you have any comments please contact social.media@hta.gov.uk

NHS’s national end of life care programme

The HTA is one of many organisations that have contributed to the development of new guidance to highlight the wide-ranging and sensitive care that nurses and their colleagues should undertake when an adult dies.

The guidance, launched in April, is for staff responsible for care after death and emphasises that care extends well beyond physically preparing the body for transfer to the mortuary or funeral director.

The care includes: ensuring that the deceased and their family/carers have their privacy and dignity respected at all times; honouring people’s wishes for organ and tissue donation; ensuring correct certification procedures have been followed; care after death being made less stressful by having discussions while the patient is still alive about issues such as organ donation and cultural attitudes towards death.

The work was initiated by the National Palliative Care Nurse Consultants Group in partnership with the National End of Life Care Programme (NEoLCP). The Royal College of Nursing and the Royal College of Pathologists have endorsed it. To download a copy, visit the end of care for adults website.To request a printed copy please email info@eolc.nhs.uk

Frequently asked questions about record retention

The HTA has recently published frequently asked questions about retention of records that enable traceability in the research, post mortem, anatomy and public display sectors. They are available on our website.

Licensing and inspections update

Since the HTA began licensing in 2006, through to the end of the 2010/11 business year, we completed 743 desk-based assessments and 615 site-visit inspections across our five licensed sectors. For the post mortem sector this means that we have now met our objective of inspecting all post mortem sector establishments within a three-year period.

To date in 2011/12, we have completed 22 site-visit inspections (15 tissue and cells for patient treatment, four research, two anatomy and one public display). There have been two desk-based assessments completed this business year – one research and one tissue and cells for treatment.

We completed more inspections in 2010/11 than in 2009/10 with 13% less resource. During this period 58% of licensed establishments provided feedback on our inspections. Respondents showed a very high level of satisfaction with HTA inspectors and our inspection process. 100% of respondents rated the overall inspection process as either good or excellent. Of these, 34% rated it as good and 66% rated it as excellent. Out of 140 respondents in the post mortem sector, 71% rated the inspection process as excellent.

You can read our latest summary report of performance against HTA standards for all sectors on our website.

Inspections are usually scheduled according to assessed risk; however they may also be scheduled randomly or on a reactive basis following receipt of information. We continue to receive positive feedback about our inspections and we are keen to hear more of your views.

Further information about our inspection process including inspection reports, can be found on our website.

Information for the public display and anatomy sectors

Making visual images – GMC guidance

In March, the General Medical Council (GMC) published new guidance on making and using visual and audio recordings of patients. We refer to this guidance in our code of practice on Anatomical examination and our code of practice on Public display.

The making and displaying of images (including photographs, films and electronic images) falls outside the scope of the Human Tissue Act 2004. However, the HTA requires Designated Individuals (DIs) to put systems in place to ensure suitable practices are carried out.

The HTA endorses the GMC’s guidance in this area. DIs need to implement systems to prevent the inappropriate use of recordings.

Update on consent for anatomical examination

Following the news story in our February e-newsletter Christopher Birkett, Head of Regulation at the HTA, wrote an article for the Law Society’s PS magazine, which clarifies some of the issues around body donation and makes a request for will writers to use the terminology in the Human Tissue Act 2004 so that potential body donations are not declined by medical schools.

In the article, which will be published in July, we encourage will writers to direct clients who wish to donate their body for anatomical examination to their local medical school.

By following the advice in the article, the number of body donations that are declined because of problems with consent documentation contained in wills should fall. For further support and guidance, please visit our website.

Information for the post mortem sector

General Directions 001/2010

The HTA reminds establishments that the deadline to provide us with an update of licensing information is 30 June as requested by General Directions 001/2010 issued last year. The Directions and supporting documentation are available on our website.

Following assessment of the information provided, we will review the risk ratings assigned to establishments last year to ensure they are appropriate. The information will also be used to inform our regulatory approach to the sector, ensuring that we target advice and guidance at those establishments most at risk of falling short of our quality standards.

Information for the organ and bone marrow transplant sector

Organ donations from living people – financial year 2010/11

Between 6 April 2010 and 31 March 2011, the HTA approved 1,207 reports from Independent Assessors (IAs). This represents a 6% increase on the previous year.

Between 6 April 2010 and 31 March 2011, the HTA referred 108 of these reports to a panel of HTA Members for decision because they involved altruistic, paired or pooled cases.

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

Between 6 April 2010 and 31 March 2011, the HTA approved 67 reports from Accredited Assessors (AAs).

Recent media stories about human tissue

April

The Yorkshire Post and The Mirror cited the HTA in continuing coverage about altruistic donation in response to our press release.

 May

The Telegraph referenced the HTA in a feature on cord blood banking, and in a news story about bone marrow donation and ‘saviour siblings’.

June

The Telegraph, The Herald and The Daily Mail mentioned the HTA in coverage about a new service which allows adults to store blastomere-like stem cells (BLSCs) for potential treatment.

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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