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The latest news from the Human Tissue Authority
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Issue 73: March 2019

HTA news

Anatomy

Human application

Organ donation and transplantation

Post mortem

Research

HTA News


EU exit: preparing for ‘no deal’

We wrote to establishments in the Organ Donation and Transplantation and Human Application sectors with guidance on EU exit planning around the arrangements they should consider if the UK leaves the EU with ‘no deal’.

If the UK leaves the EU without a deal, it will become a third country for the purposes of the EU Tissues and Cells Directive and the EU Organ Donation Directives. The UK will also consider EU Member States to be third countries.

This will mean that tissues and cells from EU member states would need to be covered by the appropriate HTA import licence. If you already have an import licence, you can apply to vary this to include individual EU member states. If you do not have an import licence, you will need to apply for a new import licence.

A requirement of import licences is that establishments have written agreements in place with suppliers in the third country, as set out in Directions 002/2018.

Additionally, if you send tissues and cells to any EU Member states you will require an export licence that covers this activity.

In the event of a ‘no deal’, there would be a six-month transitional period to allow establishments time to comply with any new requirements that result from the UK becoming a third country.

You can find information about the licence application and variation process on our website.

Please note, you will not be able to apply to vary your licences, or to apply for new licences, for imports and exports to from the EU until the UK exits the EU.

If you wish to begin to prepare your application, please refer to the information on our website about applying for and varying a licence.

Further information is available on our website.

Find out more

Important: changes to Designated Individuals and Named Contacts

We have recently noticed a significant increase in the number of applications to vary Designated Individuals (DI) and Named Contacts after these changes have occurred.

It is a breach of the statutory and standard licence conditions, under the Human Tissue Act and the Human Tissue (Quality and Safety for Human Application) Regulations, to undertake licensable activities without an HTA approved DI in post. The HTA may consider regulatory action and will factor such breaches into our assessment of risk

You must make any requests to vary these roles before the date that change is required. We recommend that you should send in your request at least two weeks before the expected date of change to allow us time to assess the suitability of the proposed change.

The Licence Holder / Corporate Licence Holder contact must submit either an Application to vary a licence to replace the DI under the Act (for the Human Tissue Act) or an Application to vary a licence to replace the DI under the Q&S Regulations (for the Quality and Safety for Human Application Regulations) to request this change.

For the ODT sector, it is a breach of the HTA’s licence Directions if there is no Named Contact in place. Details of the proposed Named Contact (including title, name, role, contact email and telephone number) must be emailed to us.

Designated Individuals, Named Contacts and Licence Holder / Corporate Licence Holder contacts are all required to notify us of any changes in their contact details. If your contact details have changed, please let us know as soon as possible.


Test yourself on HTA legislation!

We have developed a series of quizzes on the fundamental requirements of the Human Tissue Act 2004 (HT Act) and the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (Q&S Regulations).

The purpose of these tests are to provide you with a useful resource to test your knowledge on our governing legislation.

The tests are non-compulsory, taken anonymously, and will not count as an indicator of your compliance against our standards.

We have produced a set of online tests on the requirements of the Human Tissue Act 2004, which are broken down into the following five quizzes.

HT Act: Consent and licensing
HT Act: Anatomy
HT Act: Research
HT Act: Post Mortem
HT Act: Public Display
We have also developed an online test on the Q&S Regulations, which apply to establishments who use tissues and cells for human application (patient treatment).
 
Q&S Regulations
We welcome any feedback you have on these tests. Please let us know by sending us an email to enquiries@hta.gov.uk.

Good luck!

Licence fees 2019/20


A reminder to establishments that our new licence fees come into effect on 1 April 2019.

The new licence fees come with an increase of 2.7% (the CPI rate in August 2018) to the previous year’s fees. 

There have been no amendments to the model used to calculate fees for the 2019/20 financial year – as such, fees have been calculated on the same basis as last year.
 
For full information and breakdowns of fees per sector, please visit our website.

We are currently undertaking a comprehensive review of our licence fee structure with the view to implement it in 2020 and beyond. We have not undertaken a fundamental review of our fees model since 2016 but we are mindful that over the last couple of years there have been some changes to our licensing and inspection processes as well as changes to licensed establishments within all sectors.
 
Any proposals for a reviewed fees model will be developed in consultation with those affected and we will announce further updates on this in our next newsletter.

Find out more


Compliance updates 2019

We will be requesting our biennial compliance updates in autumn 2019. These ensure that we have up-to-date licensing information to guide our regulatory approach, for example, in the risk-based scheduling of site visit inspections.

For this round of compliance updates, we will be asking for information from licensed-establishments in the Research, Post Mortem, Anatomy, and Public Display sectors, and for establishments licensed in the Organ Donation and Transplantation sector, under the Quality and Safety of Organs Intended for Transplantation Regulations 2012.

As before, we will issue Directions that require all establishments in those five sectors to submit their compliance update information to us by a set deadline.

Further details on this - and full instructions on the format, completion and submission of compliance updates – will be available in upcoming newsletters and other targeted communications.

Compliance updates will need to be submitted through the HTA Portal. Please ensure that any staff who may be responsible for submitting your compliance update are registered on the Portal. If you need help with this please contact us.

Please note, compliance updates are not sought from the Human Application sector as they are inspected every two years and are required to provide annual activity data.

HTA website developments

Back in January, we shared some information on upcoming developments on the HTA website, which would allow you to:

  • Sign up to receive notifications when inspection reports are published per establishment
     
  • See when content on a page was last updated
     
  • Read, follow, and comment on blog posts on a new HTA Blog feature

You can now sign up to receive a notification when an inspection report is published for any of our licensed establishments, by going to their establishment page and clicking on this button which you’ll find on the bottom right of the page:


 
You will then just need to enter your name and email address, and the next time an inspection report publishes you will receive an email notification.
 
We have now also added date stamps to all content pages, which means you will be able to see how recently a page has been updated. This date stamp appears in the bottom left-hand corner of the page.
 
The HTA blog is currently being tested and should be up and running soon. You will be able to sign up to follow the blog so you receive a notification of any new blog posts or follow a specific blog post, and to be updated when new comments are added. We will be sharing news of our first blog post once it is live on the site, and we hope that if it is of interest to you that you get involved in the conversation.

As always, we’d be keen to hear ideas from you as to which areas we might feature in upcoming posts. Please let us know of any suggestions for blog topics that would interest you.

HTA public Authority meeting 2019


In the interests of transparency, every year the HTA commits to holding one of its  Authority meetings in public. This year the public Authority meeting will take place on Thursday 9 May in central London. This meeting is an opportunity for members of the public to attend an HTA Board meeting and observe how it functions. There will also be an opportunity to ask questions at the end of the meeting. 

You can find more information about the event, and book your place by registering your details via this short web form.

Please note, this is done on a strictly first come, first served basis, as places are limited. Members of the public who do not work at HTA-licensed establishments will receive priority for places.

Find out more

Reappointment of four Authority Members

We are pleased to announce the reappointment of four of our non-executive Board members: Dr Stuart DollowProfessor Penney LewisThe Right Reverend Graham Usher, and Dr Lorna Williamson, OBE. They will continue to work with the HTA for three additional years from 1 April 2019.

Each Member brings valuable skills and expertise to the Authority, from pathology and bio-ethics, to commercial biotech, and public health research.

Authority Members’ responsibilities include setting the strategic direction of the HTA, monitoring our performance, as well as the assessment of certain transplant cases. 

We are also very pleased that Bill Horne's term as our Interim Chair has been extended until 30 September while recruitment is underway for a new Chair of the HTA. More information on the recruitment of this post is available on our website.

We want to extend our thanks to these Members for their hard work and commitment.

Find out more

Upcoming events


Thursday 11 and Friday 12 April: Institute of Anatomical Sciences (IAS) Spring Scientific Meeting
Christopher Birkett (Head of Regulation for the Anatomy and Research sectors) and Dr Philip Bergin (Regulation Manager) will be providing an HTA update at the IAS’s spring meeting.

Thursday 9 May: HTA public Authority meeting
The HTA Public Authority meeting is an opportunity for members of the public to observe the HTA’s Board as it discusses its business. More information can be found here.
 
Friday 10 May: Association of Anatomical Pathology Technology (AAPT) consent training day
Dr Julie Edgeworth and Jennifer Scherr (Regulation Managers) will be participating in the AAPT's training day on issues involving consent.
 
Thursday 16 May: Dying Matters Awareness Week at Keele University
Dr Julie Edgeworth and Michelle Lancaster (Regulation Managers for the Post Mortem sectors) will be participating in Staffordshire’s programme of events for Dying Matters Awareness week (13-19 May).
 
Tuesday 21 May: PMOC (Police Mortuary Operations Coordination) course
Dr Julie Edgeworth (Regulation Manager for the Post Mortem sector) will be giving a presentation on the management of human remains and emergency licensing in a mass fatality situation.  
 
Wednesday 29 May: HTA Stakeholder and Fees Group meeting
The HTA’s next Stakeholder and Fees Group meeting will take place at the end of 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.
 

Anatomy

Fresh frozen material FAQs​​

Following discussions with numerous colleagues in the Anatomy sector, we have produced guidance in the form of FAQs on the use of fresh frozen material in training.

If there are any other matters or areas you think would be helpful for us to add to this (or other) guidance, please email phil.bergin@hta.gov.uk with your suggestions.
 
Find out more

Human Application

Joint statement from the HTA and MHRA on the export of tissues and cells for use in ATMP manufacture

The HTA regulates establishments that undertake the procurement, testing, processing, storage, distribution, import and export of tissues and cells for human use. This includes any steps involved in the handling of tissues and cells prior to them being manufactured into medicines.

Under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) (the Q&S Regs), the export of tissues and cells from a tissue establishment to a third country is a licensable activity, and therefore all exports of tissues and cells to such countries can only be undertaken by establishments licensed for export by the HTA.

The HTA considers the licensable activity of export as ensuring tissues and cells leaving the UK meet the required legislative standards. This licensing requirement applies to the export of all tissues and cells intended for use in human application, including those that will be used in the manufacture of an advanced therapy medicinal product (ATMP) where the tissues and cells are referred to as starting materials. In the UK, MHRA regulates the manufacture of ATMPs and confirms that GMP does not apply to the donation, procurement, testing and export of starting materials. The quality of the starting materials is key to the quality of the finished medicinal products and compliance with the Tissues and Cells legislation is an important element in providing assurance of quality.

You can find out more about the regulation of ATMPs by following the link below.

Find out more

Annual activity data submissions


Thank you to everyone in the Human Application sector who submitted their annual activity data in time for the 22 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 2019.

EUROCET will then publish a digested format of this information on their website.

The data will also help us maintain regulatory oversight and inform our risk profiling of the Human Application sector.

The Annual Activity data you have submitted is essential for us to meet our commitment to be a “right-touch” regulator, reducing burden for our licence holders where it is safe and appropriate to do so.
 

Organ Donation and Transplantation


Deemed consent in England update


The Organ Donation (Deemed Consent) Bill, or 'opt-out’ bill, has been granted Royal Assent, passing its last stage and providing official confirmation that the Bill will now become law.

From Spring 2020, adults in England will be considered potential donors unless they chose to opt out or are excluded unless they had recorded a decision not to donate or are in one of the excluded groups. These excluded groups include people who have been ordinarily resident in England for fewer than 12 months, under 18s and people who lack the capacity to understand the change.

Families will still be involved before any organ or tissue donation goes ahead, and NHS Blood and Transplant Specialist Nurses will continue to speak with families about their relative’s decision.

 

The HTA’s role


The HTA continues to work on amending our Codes of Practice A and F to provide advice and guidance to transplant practitioners in England on how changes to the new system will affect their practice.

As we informed you in our last newsletter, the majority of the changes will be seen in the new and updated Code of Practice F, which will set out the circumstances in which a person’s consent may be deemed.

We’ve also actively engaged with faith and cultural groups to ensure we have considered their views on how conversations with a donor’s relatives can be conducted in the most sensitive manner.
 
To ensure you have your say on the amended Codes, we intend to hold a 12-week consultation on the draft versions this summer.

We will provide you with further updates and information on the consultation in the next edition of the HTA e-newsletter and on our website.
 

Find out more

Updated guide to the quality and safety of organs for transplantation


The European Directorate for the Quality of Medicines & Healthcare (EDQM) have published the new 7th edition of the ‘Guide to the quality and safety of organs for transplantation’ (2018).

All chapters have been revised thoroughly to update the content with the most recent developments in the field. In addition, many new and important chapters have been added.

For more information on the guide and how to download it, please follow the link below.
 

 
Find out more

Post Mortem

NHS National Medical Examiner announced to support bereaved families and improve patient safety


Dr Alan Fletcher, a consultant in Emergency Medicine, has been appointed as the National Medical Examiner for the NHS.

In his new role Dr Fletcher will oversee the introduction of the medical examiner system in England and Wales from April 2019. The new system will ensure that every death in an acute hospital is scrutinised by either a medical examiner or a coroner so that issues with a patient care can be identified quickly to improve services for others.

Medical examiners will also contact families shortly after they have been bereaved to ensure that any concerns they have about their loved one’s care are listened to and considered at the earliest opportunity.
Medical Examiners: An introduction by Dr Alan Fletcher
Find out more


Coronial investigations of stillbirths


The government has launched a consultation on proposals to give coroners the power to investigate all full-term stillbirths – which would help provide parents with vital information on what went wrong and why, while ensuring any mistakes are identified to prevent future deaths.

The government is looking at a number of proposals which aim to:
  • bring greater independence to the way stillbirths are investigated;
  • ensure transparency and enhance the involvement of bereaved parents in stillbirth investigation processes, including in the development of recommendations aimed at improving maternity care; and
  • effectively disseminate learning from investigations across the health system to help prevent future avoidable stillbirths. 
The consultation will seek a wide range of views, from bereaved parents, the organisations that support them or that provide advice to pregnant women, researchers, health professionals and healthcare providers, as well as those working for coronial services.
Find out more

Research

Research compliance update report: 2017/18


In October 2017, we completed the collection of compliance updates for the Research sector.

We have now published an overview of the data we received. The data provides a snapshot of the key findings from the collection; identifying trends and themes we found from Research sector submissions.

We hope that this report will be useful to people working in the sector, as well as to members of the public who have an interest in medical research. You can view the publication by following the link below.
 

 
Find out more


BioIndustry Association (BIA) launch Brexit microsite  


Following the outcome of the UK’s referendum on membership of the European Union, the BIA has worked closely with members and stakeholders to identify the threats and opportunities for the biotech industry post-exit.

They have developed a new microsite that highlights the work that the BIA has done in this area. For further details and to access the microsite, please follow the link below.
Find out more
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