In this edition:
HTA news
Human application
Anatomy
Post mortem
Organ donation and transplantation
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The HTA responds to public consultations on organ donation and transplantation
The HTA has published its response to the Department of Health and Social Care's consultation on ways to potentially increase the number of deceased organ donation and tissue donors through the introduction of an ‘opt-out’ consent system in England.
In our response, we have emphasised the importance of ensuring that the public are aware of any changes to how they can make their wishes known, and explained that any change to the basis of consent to organ donation in England would necessitate amendment of the HTA’s Codes of Practice, which are based on the current legal framework.
We also submitted a response to the Department of Health for the Northern Ireland Assembly’s consultation on ways to potentially increase the number of deceased organ donation and tissue donors.
You can read both consultation responses by following the link below.
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The HTA welcomes a new Chair
Nicola Blackwood, the former MP for Oxford West and Abingdon, Under Secretary of State for Health, and Chair of the Science and Technology Select Committee, has been appointed as the new Chair of the HTA by the Secretary of State at the Department of Health and Social Care.
For more information on the appointment, please see the HTA’s press release by following the link below.
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HTA establishment button 
We have developed a new digital feature, called an establishment button, that we would like HTA-licensed establishments to display on their websites.
The button should make it clearer to the public that there is regulatory oversight of licensed activities, and enhance public confidence in your HTA-regulated activities.
It can be displayed on your homepage and/or most relevant webpage(s), and will link back to your establishment page on the HTA website, which contains details of your HTA licence, your DI, and recent inspection reports.
Please note, if you are an establishment with multiple licences or satellite sites, the button is specific to each licence, not your overarching organisation, so will only redirect to the relevant licence page on the HTA website. You may wish to have a button for each of your licences displayed on different parts of your website that relate to those licensed-activities. At this stage we are not able to provide a button that will link back to a single page with multiple licence details on it, but we are exploring options for this, or an alternative option, in the future.
If you would like to try the feature, then please let us know and we can contact you with further details. Any feedback on the feature is much appreciated, please let us know your thoughts here.
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Sharing our newsletter
All of the sectors that we regulate are constantly changing and we want to make sure that professionals working within our regulatory framework receive our latest news, guidance and updates. Our bi-monthly e-newsletter is an important source of information for professionals working in regulated sectors and transplant approvals.
If you are a Designated Individual or Licence Holder, we encourage you to share our newsletter with those working under your licence so they can stay up to date with our latest news. A link to subscribe to our newsletter can be found here, but if you know of any colleagues who don’t have access to a computer and/or email account for work purposes, please do share a hard copy of the newsletter if possible.
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Upcoming events
13 April 2018: Institute of Anatomical Sciences – IAS Spring Meeting
Dr Chitvan Amin (Head of Regulation for the Anatomy and Research sectors) will be providing an HTA update at the IAS’s spring meeting.
17 April 2018: Westminster Health Forum Keynote Seminar: The future of regenerative medicine and advanced therapies
Dr Amy Thomas (Head of Regulatory Development) will be speaking alongside Ian Rees (Manager, Inspectorate Strategy and Innovation Unit, MHRA) on 'Developing the regulatory structure: approvals, collaborative working and the relationship with the EU'.
20 April 2018: Association of Anatomical Pathology Technology: Consent Training Day
Emer O'Toole and Lisa Carter (Regulation Managers) will be participating in the AAPT's training day on issues involving consent.
9 May 2018: HTA Stakeholder and Fees group meeting
The HTA’s forthcoming Stakeholder and Fees group meeting will be taking place in early May. The group meets bi-annually to consider regulatory issues across all sectors to inform the continued development of HTA regulation and fee-setting. Minutes from previous meetings can be found here.
15 May 2018: Dying Matters Awareness Week at St George’s Hospital
Emer O’Toole (Regulation Manager) will be participating in St George’s programme of events for Dying Matters Awareness week (14-20 May).
16 May 2018: 13th Advanced Therapies & Regenerative Medicine Congress
Dr Amy Thomas (Head of Regulatory Development) will be joining a panel discussion on ‘What are the key new international developments? Ask the regulators!’
18 May 2018: Royal College of Pathologists Guidelines For Non-Forensic Autopsy Practice Symposium
The HTA will be attending RCPath’s symposium that aims to provide guidance to pathologists dealing with non-forensic and Coroner’s post-mortem examinations.
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Coding and import update
The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (the Amendment Q&S Regulations) will come into force on 1 April 2018. The Regulations transpose two EU Directives on coding and import into UK law. The changes brought about by these Regulations will affect all licensed establishments in the human application sector.
We have written to colleagues in the sector to summarise the key changes affecting those that hold a human application licence. We have also shared draft documentation to help establishments prepare for their implementation.
A summary of the key information we shared with stakeholders included:
- The revision of the HTA's Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment (the Guide), which has been updated to account for the changes brought about by the Amendment Q&S Regulations;
- The revised Guide will be issued under a new set of Directions. Directions 002/2018 will come into effect from the 1 April 2018 and will revoke and replace Directions 003/2010;
- Changes to the licensable activity of ‘distribution’;
- Minor modifications to licensing standards in the human application sector that relate to import and traceability;
- Variations to standard conditions on licences with the changes coming into effect as of 1 April; and
- Changes to import licensing following the introduction of the Amendment Q&S Regulations.
Human application sector establishments will be receiving final versions of the above before the 1 April.
We also held a live Q&A session to give establishments the opportunity to ask us any questions before the 1 April transposition date. Many thanks to those that participated on the day.
If you would like further information on these changes and how they may affect you, please contact us.
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Three years of The Regulatory Advice Service for Regenerative Medicine
The Regulatory Advice Service for Regenerative Medicine was set up in 2014 for those working in the life sciences industry. The service provides a single point of access to consolidated advice from the regulatory bodies working in the sector. These are:
The aim of the service is to provide enquirers with a combined response about the regulation of their regenerative medicine from these expert UK-based agencies. Since its establishment, the initiative has been met with widespread support, including from the BioIndustry Association and Cell Therapy Catapult.
For more information about the service, please follow the link below.
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Annual activity data collection
Thank you to everyone in the  human application sector who worked to submit their annual activity data in time for the 23 February deadline.
The information is now being reviewed and the HTA will be submitting an anonymised set of data to the European Registry for Organs, Cells and Tissues (EUROCET) in spring 2018. EUROCET will then publish a digested format of this information on their website.
The data will also help us maintain our regulatory oversight of the sector and inform our risk profiling. This information is essential for us to fulfil our goal as a right-touch regulator, reducing burden for our licence holders where it is safe and appropriate to do so.
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Body donation in the press
There has been a lot of media interest recently about body donation and in some instances, the HTA and its role has been directly mentioned. Some of these pieces include:
We understand that body donation is an area of great interest to the public and as such, we have seen an increase in the number of body donation enquiries we receive from those wanting to donate their body after death.
Our role involves providing accurate and accessible information to the public so that we maintain public confidence in our work, as well as supporting those that work with donated bodies. We provide enquirers with a body, brain and tissue donation information pack, which provides members of the public with important information about our role, and answers some frequently asked questions.
We are aware that medical schools are sometimes approached by journalists who may be developing a story on body donation, and are sometimes unsure of how they can be involved in the work and what kind of information they can share.
There can be positive aspects to well-made articles, and it is of course up to individual establishments to make any decisions on whether to cooperate with journalists or not. We would encourage establishments to contact us if they are unsure of their regulatory requirements.
Our Code of Practice on Anatomy is available on our website, and you can find our guidelines for journalists and documentary makers looking to use still or moving images of human bodies and body parts on our website here. Please contact us for any further advice and guidance.
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The HTA joins the panel for the Death Before Birth stakeholder workshop
The Death Before Birth project held a stakeholder workshop in February. It was a successful exchange of perspectives and insights between participants on the day.
With over 30 attendees, that included:
- medical doctors;
- midwives;
- funerary industry professionals;
- representatives of regulatory bodies;
- charities supporting people who have experienced pregnancy loss; and
- people who have lost a pregnancy to miscarriage, termination, or stillbirth.
The workshop brought together a variety of perspectives to discuss the complex issue of pregnancy loss.
The event included a final panel, “Professional support and policy: Actions for change”, which was a discussion held by the HTA’s Adam Whittaker, Ruth Bender-Atik of Miscarriage Association, Ross Jones from Sands, and Brendan Day of Federation of Burial and Cremation Authorities. The panellists offered their reflections on issues raised in the workshop as well as indicating possible directions for the future of bereavement care pathways following pregnancy loss.
The day provided an excellent opportunity for the group to share their perspectives on the issue of pregnancy loss.
More information on the project and our involvement is available by following the link below.
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Organ donation and transplantation
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Social media and living organ donation
The work we do with living organ donors and recipients was highlighted in a piece by BBC South Today that included an interview with Jessica Porter, HTA’s Head of Regulation for the Organ Donation and Transplantation sector. The interview was about the role of social media in living organ donation and the criteria that must be met in all living organ donation cases.
We have further information available on our website to potential donors, recipients and those setting up organ matching websites that aim to bring these people together on how the system works in the UK and issues to consider for those using social media to seek a donor.
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