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Compliance update submissions will close at 5pm on 2 October 2017.
All establishments with a licence, or licences, in the sectors listed below must submit the compliance update questionnaire on the HTA portal.
You can access the compliance update questionnaires by clicking on the relevant sector above.
Regulatory action
Completion of the compliance update is mandatory and a failure to complete it would constitute a breach of the HTA Directions. This may lead to consideration of regulatory action.
If you have any questions, please contact licensing.enquiries@hta.gov.uk
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The European Centre for Disease Prevention and Control (ECDC) has produced a rapid risk assessment concerning the clusters of autochthonous chikungunya cases in Italy (Anzio and Rome). The ECDC have recommended measures should be taken to prevent the transmission of chikungunya through substances of human origin.
If you work in an establishment in the human application or organ donation and transplantation sector, you should review your donor selection procedures.
You can find more information on chikungunya on our website, and a copy of the risk assessment can be found on the ECDC website.
The Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC) Donor Selection Guidelines, with reference to Italy and Tropical Viruses, are also being updated. The updated guidelines will be available on the JPAC website from 2 October.
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Congratulations to our Authority member, Dr Lorna Williamson OBE, on receiving the James Blundell Award from the British Blood Transfusion Society (BBTS).
The James Blundell Award is given for original research resulting in an important and significant contribution to the body of medical and or scientific knowledge within the field of blood transfusion.
You can find out more about the BBTS awards here.
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When the HTA moves to make some decisions, the establishment involved is able to make representations against the proposed course of action. This is the case when we propose to:
- refuse a licence
- revoke a licence
- vary a licence, or
- impose conditions on a licence
We rarely find ourselves in the position of needing to propose such a decision. However, when we have, the representations process we previously followed was overly burdensome to all parties. We have reviewed the process with the aim of resolving promptly while still taking into account all relevant factors.
You can find an overview of the new process on our website.
As shown in the diagram, there is the right to appeal following the representations process, and an appeal is considered by a panel made up of five members of the HTA’s Board. Following an appeal, an establishment may seek leave for a judicial review the HTA’s decision.
Thank you to those which have provided input to this work. We have committed to reviewing the new process after its first use and we will update you on any changes in this newsletter.
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October is a busy month for the HTA's Committees and workings groups.
The following meetings will take place:
You can find out more about the HTA's committees and working groups, including previous meeting papers on our website.
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As we said in the previous eNewsletter, the Parliamentary process for the Regulations to implement the Import and Coding Directives was paused ahead of the General Election earlier this year.
For now, this means the Regulations are not yet legally binding in the UK. The Directives are, however, in force in other European Member States. If you distribute tissues and cells intended for human application to other countries in the EU, you may be affected. We recommend that you contact us for further advice on how to comply with the Directives.
For those preparing for implementation in the UK, the draft HTA guidance on the Directives remains on our website, and we are currently updating this following your feedback.
We will share an updated timetable for transposition as soon as it is available. If you have any questions about this please contact us either by email or by phone on 020 7269 1900.
Publication of new SaBTO Report
The Advisory Committee on the Safety of Blood, Tissues and Organs (SaBTO) was asked by Ministers to review donor selection criteria in the UK in relation to behaviours that may increase the risk of acquiring specific blood-borne infections.
Following the review, SaBTO have published their ‘Donor Selection Criteria Report’. The report recommends changes to donor selection criteria based on assessment of these risks, including sexual behaviours and behaviours that involve piercing of the skin such as tattoos. The report contains recommendations for donor selection criteria for donors of non-reproductive tissues and cells, which have been accepted by ministers.
What does this mean in terms of the HA sector?
The Human Tissue (Quality and Safety for Human Application) Regulations 2007 require that donor exclusion is based on evidence of risk factors for transmissible diseases. Donor exclusion must be on the basis of a risk assessment, taking into consideration donor travel and exposure history and local infectious disease prevalence.
If you are involved in donor selection, the new SaBTO report should inform your own risk assessments and donor selection procedures. You must also consider the testing algorithm used to screen donors when considering exclusion criteria.
Third Edition of EDQM's Tissues and Cells Guide
The European Directorate for the Quality of Medicines (EDQM) has published the third edition of the Guide to the quality and safety of tissues and cells for human application.
The Guide collates updated information for transplant professionals. The Guide includes an overview of advances in the field as well as technical guidance for ensuring the quality and safety of human tissues and cells for patient treatment.
To access the Guide, you can either:
Risk in the Human Application sector
Thank you to those who shared their views on some of the risks associated with the Human Application sector.
We published a survey through the last HTA newsletter. This forms part of a six-month project to consider ways in which we can further target our regulatory approach, based on risk to both patient safety and to public confidence.
We are working through your responses and will share a summary of these in due course.
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The UK Clinical Research Collaboration (UKCRC) Tissue Directory and Coordination Centre are hosting their annual meeting UK Biobanking Showcase this autumn at the Oval in London.
Date: 18 October
Time: 10am – 5.30pm
Location: London
At the meeting, you will be able to:
- find out about the latest developments in UK-based biobanking;
- hear from experts on the patient perspective, SMEs, research ethics and quality standards; and
- discuss how the work of biobanks can be better recognised.
Featuring lots of time for networking, debates and discussion, the event will be a unique chance to hear about and shape the future of the UKCRC Tissue Directory and Coordination Centre.
Register here: https://www.biobankinguk.org/event/uk-biobanking-annual-meeting/
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In August, the EU published an updated guide on preparedness for Zika and safety of substances of human origin.
We expect establishments to follow the advice given by advisory bodies on Zika virus which are relevant to the sector in which they operate. You can find links to guidance from the following bodies on our website:
- European Centre for Disease Prevention and Control
- Joint UKBTS Professional Advisory Committee
- World Health Organisation
- Centers for Disease Prevention and Control
- NHS Blood and Transplant
Organ Donation Week 2017
Organ Donation Week took place between 4-10 September this year. It is an annual campaign held by NHS Blood and Transplant (NHSBT) to raise awareness around organ donation.
This year, NHSBT focused on not only encouraging people to join the organ donor register, but also on the importance of sharing your decision to donate with your family.
Hundreds of people and organisations all across the country, including the HTA, contributed to the campaign online helping to make it a success.
As well as the public campaign, NHSBT and Kidney Care UK held a parliamentary event in Westminster on Wednesday 6 September. The event was attended by sixty MPs, including Jackie Doyle-Price MP, the Parliamentary Under Secretary of State for Health. Those attending were encouraged to promote organ donation by taking their messages of support for organ donation back to their constituencies.
You can find out more information about Organ Donation Week on NHSBT's website or on our twitter page.
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