E-newsletter issue 32 - December 2011

Welcome to the December issue of the Human Tissue Authority’s (HTA’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 an update on the HTA’s licence fees, the latest news on the arm’s-length bodies review, the EU Organ Donation Directive, and news about our request for annual activity data from the tissue and cells for patient treatment sector. We also launch new public-facing information on post- mortem examinations.

We wish all our readers a happy festive season. 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

Licence fees 2012/13

Following the HTA’s recent review, the Authority has agreed licence fees for 2012/13.

We have been able to reduce fees for the second year running by making further efficiencies. Overall, the amount of fee income we receive will reduce by approximately 17% in 2012/13. Fees have been adjusted to reflect the expected costs of regulating each sector and the plans for inspecting each sector.

The structure of the items for which we charge fees remains the same. The only refinement is that for 2012/13 there will be two different fee levels for satellite sites in the post mortem sector. A fee of £800 for satellites who only store blocks and slides has been introduced. Other satellites will be charged £1,900, reflecting the amount of time we need to spend to inspect these more complex satellites. These changes better reflect the costs of regulating different types of satellites.

The HTA will be issuing invoices to establishments in the tissue and cells for patient treatment (human application) sector in April and all other sectors in September.

Fees for the new organ transplantation sector, arising as a result of the EU Organ Donation Directive that comes into force in August 2012, will be announced in March 2012.

 Arm’s-length bodies review

At the time of drafting, the Department of Health (DH) still intends to consult on the transfer of the HTA’s and Human Fertilisation and Embryology Authority’s (HFEA’s) functions. We now expect this to take place in the New Year. There will probably also be a subsequent consultation at some point in the future focusing on using the powers under the Public Bodies Bill to affect the transfer.

The HTA continues to argue that the functions we regulate should stay together to ensure public confidence; we are less concerned where those functions transfer. The Government’s preferred option is to transfer our functions in their entirety to the Care Quality Commission (CQC) and they intend to consult on that basis, whilst remaining open to receiving views on the way forward from stakeholders. Our ambition of keeping all our functions together is therefore supported, which is good news for public confidence in the safe and ethical use of human tissues and organs, with proper consent.

Public Bodies Bill

The Public Bodies Bill received Royal Assent on 14 December when it became an Act of Parliament. The HTA and HFEA remain in schedule 5 of the Act, which allows the modification or transfer of our functions by Ministers. The Bill passed through its final Committee stage in the House of Commons on 11 October, before reaching Report stage and third reading on 25 October. It reached ‘ping-pong’ stage (referring to the to and fro of amendments to Bills between the House of Commons and the House of Lords) on 23 November.

During the Committee stage on 11 October, MPs debated amendments to remove the HTA and HFEA from schedule 5. The HTA amendment was tabled by Valerie Vaz MP, member of the Health Select Committee. David Heath, Deputy Leader of the House of Commons, spoke in response to the amendments, which were later withdrawn. A similar debate took place during the final Committee stages in the House of Lords. In both houses there was continued consensus that both the HTA and the HFEA do important work.

Chief Coroner

During the debates on the Public Bodies Bill in the Commons, the Parliamentary Under-Secretary of State for Justice (Mr Jonathan Djanogly) stated that the Government no longer intend to abolish the post of the Chief Coroner. The HTA issued a statement on this development.

Health and Social Care Bill

Peers debated amendments relating to the Health Research Authority (HRA) during Committee stage of the Health and Social Care Bill on 7 December (more detail on the HRA is below). These amendments, tabled by Lord Willis of Knaresborough and other peers, were designed to seek commitments from the Government on the HRA and to transfer the HTA’s and HFEA’s research functions to the new Authority. HTA Chair Baroness Warwick spoke to the amendments. Whilst supporting the establishment of the HRA and the intentions behind the amendments, she set out why we and the DH believe that our functions should not transfer to the HRA. She also highlighted our commitment to collaboration for the benefit of researchers. Lord Walton of Detchant expressed concerns about the HTA’s functions transferring to the CQC.

In response, Earl Howe (Parliamentary Under Secretary of State (Quality), Health) said the Government was still intent on consulting on the HFEA and the HTA, and hopes to do so shortly. He added that the HRA “will have substantive functions as a special health authority. It will combine and streamline approvals for health research through unification of functions and processes.” He said the HRA will work closely with the HTA, the HFEA and the National Institute for Health Research to coordinate relevant functions, processes and standards.

The Bill will now return to the Lords for a debate on the amendments made by the Commons (a date is yet to be set), before passing through for Royal Assent.

We will continue to keep stakeholders regularly updated on these issues and the Department’s consultation in our e-newsletter. For more information visit our ALB webpage or read the papers from our November Authority meeting. Each Authority meeting has on update on progress with the ALB Review.

Authority meeting, 22 November

The HTA held an Authority meeting on 22 November in London. Issues discussed included plans to implement the EU Organ Donation Directive and licence fee proposals for 2012/13. Decisions were made about the proposed framework for living organ donation assessment, and licensing recommendations for the removal of tissue for a scheduled purpose. Members also discussed the HTA’s response to the Welsh Government’s consultation on the introduction of presumed consent in Wales. You can download the meeting papers from our website.

Collaborative work

The HTA’s strategic plan for 2012/13 and thereafter places great emphasis on collaboration. Building on the progress we have already made, activities planned for 2012/13 include:

• Participating in a Joint Working Group with the CQC and HFEA to share intelligence on establishments and streamline our approach to inspections. We are also working with Healthcare Inspectorate Wales, Healthcare Improvement Scotland and the Regulation and Quality Improvement Authority (Northern Ireland) to achieve similar outcomes.
• Research sector: we will work closely with the Health Research Authority to provide a single point of access for researchers that retains all the strengths of the current systems, and fully meets the requirements of the legislation.
• Post mortem sector: working with Clinical Pathology Accreditation to develop a programme of joint inspections.
• Tissue and cells for patient treatment (human application) sector: working closely with the Medicines and Healthcare products Regulatory Agency to deliver joint inspections of the 12 establishments licensed by both organisations for development of Advanced Therapy Medicinal Products (ATMPs).

Examples of our current and past collaborations follow:

• We worked with the National Research Ethics Service to ensure that:
• Our advice and guidance is coherent, consistent and valued by researchers, through jointly produced guidance, workshops and sharing information.
• More than 200 HTA-licensed tissue banks can now benefit from a streamlined process where Research Ethics Committees give generic approval for tissue collection, storage and release arrangements, so researchers obtaining tissue can do so without a HTA licence or Ethics Committee approval. This voluntary scheme has been extremely popular and has resulted in over 200 of these banks, increasing the availability of quality material while reducing the regulatory burden.
• As well as the UK stem cell tool kit, we also helped the Medical Research Council develop their Data and Tissues Tool Kit, providing guidance for researchers.
• In addition, we helped National Institute for Health Research (NIHR) Clinical Research Network develop a bespoke training package for R&D managers and governance staff based at NIHR Comprehensive Local Research Networks and NHS Trusts in England. The online training will be supplemented by a parallel programme of locally led workshop sessions intended to share good practice amongst peers. The Human Tissue Act material is expected to be available shortly through the NIHR CRN’s Learning Management System.

The HTA’s new strategic plan will be published in April 2012.

 Position statement published on extending existing licences to cover the removal of tissue from the deceased for research

The HTA has published a statement on extending existing licences to cover the removal of tissue from the deceased for research. Designated Individuals (DIs) who wish to extend their removal licence can request an extension by writing to the HTA, via licensing.enquiries@hta.gov.uk.

Going further than this, at our November Authority meeting, we decided to develop and introduce a new licence type during the 2012/13 business year. This will cover removal of material from the deceased for a number of purposes set out in the Human Tissue Act. This new licensing option will give organisations even greater flexibility to choose the licence profile that best fits their needs while ensuring that the requirements of the HT Act are met. More information will follow as the project gathers pace.

More information about licensing is 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 123 site-visit inspections (55 tissue and cells for patient treatment, 45 post mortem, 18 research, 4 anatomy and 1 public display). We have completed 16 desk-based assessments this business year – 8 tissue and cells for treatment, and 8 research.

We continue to receive very positive feedback on our inspections. For quarters one and two of 2011/12, 99% of respondents rated the overall inspection process as ‘good’ or ‘excellent’, with more than two-thirds of these rating it as ‘excellent’. Furthermore, 87% of respondents told us that the inspection process has helped improve the way they work.

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 research sector

Health Research Authority 

The Health Research Authority (HRA) was established on 1 December as a Special Health Authority. Its purpose is to protect and promote the interests of patients and the public in health research. The HRA, which has now taken over the functions of the National Research Ethics Service (NRES), will cooperate with others to combine and streamline the current approval system and promote consistent, proportionate standards for compliance and inspection. The HTA is fully committed to working closely with the HRA to support these objectives, as demonstrated though our work with NRES and others (see section on collaboration above).

The Government intends to transfer other functions to the HRA and legislate to establish it as a non-departmental public body. It also expects other bodies like the HTA to work closely with the HRA and we expect and hope to be judged on that for the benefit of research.

Our Chair and members of the executive team met the HRA’s departmental sponsors on 31 October. The discussion focused on how we would continue to support biomedical research and public and professional confidence in regulation under the new arrangements.

More information about the HRA is on the Department of Health and HRA websites, which includes a plan for forthcoming activity.

Information for the tissue and cells for patient treatment sector

Annual activity data

We will shortly be contacting all tissue and cells for patient treatment establishments licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 to request your annual activity data. These data cover the period January to December 2011. As we did last year, we are asking establishments to submit the data online. We will be asking for numbers of donor procurements and testing, processing and storage, and distribution, import and export. Please start gathering your data now.

The new data submission form will be available online from 3 January 2012 and an email will be sent out to Designated Individuals with a link to the relevant webpage. The completed annual activity data must be submitted to us by 31 January 2012. Please note that it is a standard condition on your licence to supply us with these data. Thank you for your help in meeting this request.

For further information please email enquiries@hta.gov.uk  or call 020 7269 1900.

European Court of Justice ruling

Whilst not in the HTA’s remit, readers may wish to know that the Medical Research Council has issued a statement on the recent high profile ruling by the European Court of Justice (ECJ) banning the patenting of inventions involving human embryonic stem cells (hESCs). It says that the ”implications of the European Court ruling, made on 18 October, will not be fully apparent until the Government, industry and the academic community have had time to make an assessment. However, the ruling has already raised concerns that the inability to patent discoveries will deter inward investment in research and development from the commercial sector.” As well as announcing additional funding, the statement notes that the judgement does not have any impact on the ability to undertake hESC research in the UK.

Information for the post mortem sector

Public information on post-mortem examination and retention of organs and tissue

In line with our recent strategic shift towards empowering the public in making decisions, the HTA has produced a document on what public expectations should be for the retention of post mortem tissue.

The information, which covers both Coroners and hospital post mortems, also clarifies the Human Tissue Act’s requirements for professionals, and helps address issues we have identified on inspection. Establishments can adapt the information for local use, which we hope will support communications between families, Pathologists, Coroners and the police in ensuring tissue is not retained without consent.

We encourage stakeholders, establishments and patient groups to publish the information on their websites, use it during discussions, and/or update existing resources, if appropriate. Establishments should remove all copies of the now obsolete DH document A guide to the post mortem examination procedure.

If you plan to issue the text though your own communications channels, please let us know so we can evaluate interest and provide further advice if needed. Because it may be updated from time to time, you may wish to link to the text that is published on our website. This information is also available as a set of FAQs online.

Thanks to members of the public and public-facing organisations including the Bereavement Advice Centre, Patient Concern, Patients Association, Cruse Bereavement Care, the Stillbirth & neonatal death charity, INQUEST, the Royal College of Pathologists Lay Advisory Committee, as well as our Department of Health policy branch, Ministry of Justice, past and present Authority Members, and the HTA Histopathology Working Group.

If you have any feedback please contact enquiries@hta.gov.uk.

Serious incident at Hull Royal Infirmary

You may be aware of a recent serious untoward incident at Hull Royal Infirmary, where it was discovered that the body of a person in long-term storage, was that of someone who was thought to have been buried several years ago. The Trust notified the HTA about the incident, which has caused great distress to the families involved. The HTA was subsequently invited by the Chief Executive to inspect the establishment to provide assurance to the Trust’s Board that HTA minimum standards are being met and to aim to reassure local people who may have lost confidence in the service.

The inspection has now taken place and the report will be published on our website in the New Year. It will contain information about the very effective steps that have been taken at Hull Royal Infirmary in relation to the management of long-term body storage, and these will be of interest to any establishment that has capacity for the long term storage of bodies. We will alert you, via our e-newsletter, when the report is available. In the meantime, we ask that you undertake a thorough audit of all bodies in long-term storage, checking their identity and the authority for their continued storage. If you have any concerns or questions, please contact us. Our inspection teams will be asking you about your long-term body storage arrangements and will expect to see evidence to demonstrate that you have undertaken appropriate checks.

The HTA’s statement on the incident is on our website.

Serious untoward incident reporting

With input from the Histopathology Working Group, the HTA has reviewed its categories of serious untoward incident (SUI). Two new categories have been added:

• Disposal or retention of a whole fetus or fetal tissue (gestational age less than 24 weeks) against the express wishes of the family.
• Viewing of the wrong body by the deceased’s family.

These new categories have been introduced because the Group felt that they may be potential indicators of wider system problems, and therefore warrant consideration by the HTA.

Slight amendments have been made to the wording of other SUI categories for the sake of clarity. The complete list, with the amendments, can be accessed via our website.

Office of the Chief Coroner

The HTA issued a statement about the office of the Chief Coroner, which the Government plans to reinstate.

Information for the organ and bone marrow transplant sector

EU Organ Donation Directive update

As outlined in the October e-newsletter, the HTA is currently consulting on the draft Documentary Framework for the Quality and Safety of Human Organs Intended for Transplantation. This consultation is running in parallel with the Department of Health’s consultation on the draft Statutory Instrument and associated Impact Assessment. Both consultations close today (Wednesday 21 December). The Government has agreed to implement the EU Directive and has appointed the HTA as the Competent Authority, as each Member State must implement the Directive though a regulatory framework.

Revision of living donor information leaflets for patients

The HTA ‘Information about living donor transplants’ leaflet has now been revised. The new version is available to download on our website. Hard copies are also available on request via enquiries@hta.gov.uk. The revised leaflet is also available in Welsh, Urdu, Gujarati, Hindi, Punjabi and Bengali.

NICE: clinical guideline – Organ donation

On 12 December the National Institute for Health and Clinical Excellence (NICE) published their organ donation guideline. The HTA submitted comments on the draft in February during the consultation process and we welcome the guidance.

Organ donations from living people

Between 1 April 2011 and 31 October 2011, the HTA approved 629 reports from Independent Assessors.

Between 1 April 2011 and 31 October 2011, the HTA referred 55 reports to a panel of HTA Members for decision they involved altruistic, paired or pooled cases.

You can read more about organ donation on our website.

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

Between 1 April 2011 and 31 October 2011, the HTA approved 41 reports from Accredited Assessors (AAs).

You can read more about bone marrow donation on our website.

Christmas office opening hours for transplant assessments

Should a transplant unit have an emergency case during normal office hours – Monday to Friday 9.00am to 5.00pm – then please contact the HTA transplant team on 020 7269 1900. The office will be closed on 26 and 27 December. Members of the transplant team will be contactable on 28, 29 and 30 December.

Where emergency cases occur when the office is closed* please contact the duty office at NHS Blood and Transplant. The duty officer will then contact a representative at the HTA, who will be able to assess the case and provide a decision.

* Over Christmas this includes 24, 25,  26  and 27 December.

Recent media stories about human tissue

October

HTA Authority Member Keith Rigg was quoted in BBC coverage of the Nuffield consultation on human bodies in medicine and research. The Daily Telegraph cited the Human Tissue Act in a transplant story.

November

The Daily Telegraph and NHS Choices referenced the HTA in coverage of altruistic donation. The Blackpool Gazette named the HTA in a public display story. The Human Tissue Act was cited in coverage on Tissue retention in the aftermath Hillsborough Disaster on the BBC News Liverpool website, The Liverpool Echo and The Mirror. In November we published a statement about the reinstatement of the post of Chief Coroner, our response to the Welsh Government’s White Paper on presumed consent, and the serious untoward incident at Hull and East Yorkshire Hospitals NHS Trust.

December

The Daily Telegraph, BBC, The Metro and The Daily Mail mentioned the HTA in a story about public display. Madeformums.com cited the HTA in a story about cord blood. The HTA was also referenced in a BioNews story on the arm’s-length bodies’ review. The Human Tissue Act was mentioned in a story about presumed consent on Walesonline.co.uk. New Scientist highlighted the HTA in a story about stem cells.

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