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Issue 53 / October 2015

HTA news Sector news

Human application news Post mortem news Transplantation news Anatomy news

Government review of the HTA

Thank you to everyone who responded to the Government’s call for evidence for the triennial review of the HTA. This review, which was open from 14 July until 31 August, was seeking views from our stakeholders and partner organisations on the role and performance of the HTA. Once the feedback has been analysed, the outcome and recommendations will be available to download here

Codes of Practice and Standards consultation

The consultation on the HTA’s draft Codes of Practice and Standards opened on 1 September 2015. The draft Codes and Standards are available on our website, along with summaries of the key changes and information about how to respond. 

We encourage you to respond to the consultation to help ensure the Codes and Standards are fit for purpose. You can respond online, or by downloading and sending a copy of the survey. If you have any questions at all, please contact us. The consultation will close on 31 October.

We would also like to thank all those who signed up to attend the workshops in London, Leeds, Cardiff and Belfast, and to those who have already submitted responses to the consultation; your input will help make the Codes and Standards stronger. The final workshop will be held in Bridgend (near Cardiff) on 14 October 2015. If you would like to attend, please contact us for details.

Compliance assessments

For establishments licensed under the Human Tissue Act (2004):

This year, establishments licensed under the Human Tissue Act (2004) are required to review their licensing records and complete a compliance update. Compliance updates have already been collected from establishments licensed in the post-mortem sector, except for storage only establishments.

We will be writing to all other Designated Individuals and Licence Holders later in October with advance notice of the questions that will need to be answered when completing the compliance update. In early November, the HTA will issue Directions, compliance update questions, and full instructions for how to complete and submit the information required. Establishments will have approximately one month to complete and submit their compliance updates via our online portal. Full information on the submission date will be available in early November when Directions are issued. The information will be used to maintain our regulatory oversight, guide our regulatory approach, and inform our risk profiling and the scheduling of site visits. 

For establishments licensed under the European Union Organ Donation Directive (2012):

This is the first time that establishments licensed under the European Union Organ Donation Directive (2012) have been required to carry out a comprehensive review of the activities performed under their HTA Organ Donation and Transplant (ODT) licence, and to complete a compliance update assessment. An editable version of the template was issued on the 28 September alongside HTA Directions which bring into force mandatory compliance reporting for establishments with an HTA ODT licence. The deadline is 19 October 2015. 

The information gathered through this exercise will be used to update our licensing records, and will contribute to the development of our regulatory strategy to ensure that we continue to reduce burden and target our resources efficiently and effectively. More information can be found here.

Licensing and inspection review 

We have been reviewing our licensing and inspection processes and have identified several opportunities for delivering efficiencies. We are also currently upgrading and improving our licensing technology and database, to streamline the way that we capture and use information about licensed establishments, and to improve the quality and clarity of the information we provide to our stakeholders.

The next stage of the review is to seek more detailed feedback from our stakeholders about the areas we have identified for improvement. This will likely be through surveys and small working groups that will be convened over the coming months and continuing into 2016. If you are interested in getting involved in this work, please let us know.

PEALS 16th Annual International Symposium, 'Donors, money and body parts'

Dr Chitvan Amin, HTA Regulation Manager and Christopher Birkett, HTA Head of Regulation, participated in this fascinating Policy, Ethics and Life Sciences (PEALS) event at the Newcastle Centre for Life on 22-23 September. The event was organised by the Policy Ethics and Life Sciences (PEALS) Research Centre at Newcastle University. The presentations and discussions covered a wide range of issues relating to donations and payments. It was also a good opportunity to meet new colleagues and foster new links which will be useful for future policy work.

'Informed consent in a digital age' - Winter NCRI and CCB meeting

On 11 December, the International Centre for Life in Newcastle is hosting the National Cancer Research Institute’s Confederation of Cancer Biobanks Winter meeting on ‘Informed Consent in a Digital Age’. Sarah Bedwell, HTA Director of Regulation, and Amanda Gibbon, HTA Authority Member, are both speaking at the event. The meeting will explore the meaning and importance of informed consent from the perspective of the donor, regulator and scientist, and explore new ways in which consent may be obtained using online techniques. More information and registration details can be found here.

HTA meetings in October 

The Histopathology Working Group meeting, which happens twice-yearly, will next take place on 30 October, and the minutes will be published here. The twice-yearly HTA Stakeholder Group meeting is next happening on 8 October, the minutes will be published here. The minutes of the 6 October Transplant Advisory Group meeting will be published here and the minutes of the 27 October HTA Authority meeting will be published here

Licence fees 2015/16 - explanatory notes 

We would like to inform all of our licence holders that we have updated our licence fee explanatory notes. These can be found on our website. Please contact us if you have any feedback or queries regarding this information.

Human application sector news

Coding and import update

The new EU Directives for the coding and import of tissues and cells for human application are due to come into force throughout the EU on, or before, 29 April 2017. To assist you in preparing for the implementation of these Directives, here is an overview of the work that the HTA is undertaking with the Department of Health and the timeframes that the HTA is working to. If you have any questions about this information, or about either Directive, please contact the HTA.

EU consultation on good manufacturing practice for ATMPs

The EU Commission is currently running a consultation on the development of guidelines on Good Manufacturing Practice  specific to Advanced Therapy Medicinal Products. This consultation will run until 12 November 2015 and is targeted at all stakeholders involved in the development, manufacture and/or commercialisation of advanced therapy medicinal products. Comments from small and medium-sized enterprises are particularly welcome.

Department of Health seeking a new SaBTO Chair

SaBTO, the government Advisory Committee on the Safety of Blood, Tissues and Organs, is seeking a new Chair. For further information, please visit the Department of Health website. The closing date for applications is midday on 13 October 2015.

Regulatory Advice Service for Regenerative Medicine

It has now been a year since the Regulatory Advice Service for Regenerative Medicine (the Advice Service) was launched by Minister for Life Sciences, George Freeman. The Advice Service offers research and development professionals across academia, industry and the NHS, a single point of access to free, clear, cross-regulatory, expert advice about the regulation of regenerative medicines. Find out more about the advice service and how to access it here.

Post mortem sector

Post mortem compliance update - thank you!

Thank you to everyone in the post mortem sector who worked to review their licensing records and complete a compliance update in time for the 7 August deadline. The information is now being reviewed and will be used to maintain our oversight of this sector, and inform our risk profiling and the scheduling of site visits. This information is essential for us to fulfil out goal as right-touch regulators, reducing burden for our licence holders where it is safe and appropriate to do so. 

Brain and spinal cord questionnaire

We have invited establishments licensed in the PM sector to participate in this short survey about brain and spinal cord retrieval. Thank you to the 40 establishments  who have responded so far. We would be grateful if remaining establishments would respond; we are keen to hear from both those who do and those who do not undertake brain and spinal cord retrieval. The deadline has been extended to the end of day on 9 October. The results of the survey will help us determine whether more can be done to ensure that those who wish to donate are able to so.

Body storage capacity and contingency arrangements

During winter last year, the HTA became aware that some establishments were experiencing difficulties with body storage capacity. This prompted the inclusion of specific questions on storage capacity and contingency arrangements in the 2015 compliance update. 

We are using the information we have received to evaluate the pressures on body storage arrangements. We are also planning to make some general recommendations for consideration by all mortuaries and other parties affected, including local authorities, coroners and resilience planning teams, and will be sharing these with the sectors in the next few weeks.

If your establishment would like advice from the HTA on strengthening your contingency arrangements for storage, please contact the Regulation team.

Transplantation sector

HTA publishes guide to consent and organ donation

As part of the National Transplant Week Campaign, the HTA published a guide to consent and organ donation. The guide, developed in collaboration with NHS Blood and Transplant, is for those who have registered or who are considering registering their decision to donate on the NHS Organ Donor Register (ODR). The guide, explains how decisions about organ donation, recorded on the ODR, are managed under the law. It highlights what the law says about giving consent, and outlines the importance of sharing decisions about being a donor with family and close friends. 

Bone marrow and PBSC sector: model declaration form no longer in use

As part of our guidance for this sector, in the past, we provided a model declaration form to clinicians for bone marrow and Peripheral Blood Stem Cell transplants. This was withdrawn some time ago, and is no longer in use - please discontinue use of the form. We published new guidance for the sector in May 2015 and this should be referred to for all up-to-date information. It is available on the HTA website

Anatomy sector

Institute of Anatomical Sciences Autumn Meeting

Christopher Birkett, HTA Head of Regulation, attended this meeting at Bristol University on 3 September. He gave a presentation which covered the findings in the Anatomy Sector Review that the HTA published in March this year. It was a great opportunity to catch up with our anatomy sector colleagues and share their successes and achievements. The programme for the meeting can be found here.
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