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Welcome to the Human Tissue Authority newsletter
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Issue 61 / March 2017

HTA news

Sector news

Human Application

Post mortem

Research

Organ donation and transplantation

  

Codes of Practice and Standards:
Under two weeks to go until launch!

Our revised Codes of Practice and Standards are due to come into force on 3 April 2017.

In the lead-up to the launch, we have been sharing key information with you in a series of newsletters. These newsletters also contain useful tips to help establishments prepare for implementation.

Don't worry if you've missed a newsletter - all of the newsletters and other key information is available on our website. You can also find the draft versions of the new Codes and Standards on our website.

If you have any questions regarding the new Codes and Standards, please get in touch with us.

Webinars

During February and early March, we hosted a series of webinars that focused on the key changes to each Code and the corresponding licensing Standards. 

We’re delighted to have received very positive feedback following the webinars and we will be looking at how we can further develop online training opportunities in the future.

In case you missed any of the sessions, the presentations are now available to view on YouTube and will also be available on the HTA website from the 3 April.

Are your contact details up to date?


It is important to us that we can contact Designated Individuals (DIs) and Corporate Licence Holders (CLHs) by email. Occasionally, local inbox settings or changes in staff prevent our emails from being delivered.

We would be grateful if DIs and CLHs could ensure that their contact details are up to date and their email settings allow HTA emails to be delivered. Alternatively, you can supply us with an alternative email address for us to use.

To update your contact details, please email our licensing team.

Compliance updates 2017
 

We will be requesting our biennial compliance updates in Autumn 2017. These ensure that we have up-to-date licensing information and guide our regulatory approaches, for example, in the risk-based scheduling of our site visit inspections.
 
For this round of compliance updates, as well as asking for information from establishments licensed in our research, post mortem, anatomy and public display sectors, we will also be seeking updates from organisations licensed under the Quality and Safety of Organs Intended for Transplantation Regulations 2012.
 
As before, we will issue Directions to require all establishments in those five sectors to submit 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.
 
Compliance updates are not sought from the Human Application sector as they are inspected every two years and they are required to provide annual activity data.

Save the date! HTA Conference 2017
 

The HTA conference will be taking place on Tuesday 27 June this year, in Pimlico, London.
 
There will be a morning session incorporating the public Authority meeting, and an afternoon session featuring guest speakers and debate. During the lunch break there will be the opportunity to talk to Heads of Regulation and their teams, and to learn more about what the HTA are currently working on.
 
If you would like to attend the day, or just the morning or afternoon sessions, please register your interest .
 
Please note - space is limited, and tickets will be allocated on a first come first served basis per sector, so please do register your interest soon.
 
We will be sending out more information regarding the content of the day, including speakers and sessions in due course, but if you have any questions about the event please contact us.
 
We look forward to seeing you there!
 

Human application sector news

Coding and Import update

The Department of Health (DH) is consulting on the draft Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2017. The draft Regulations transpose two new EU Directives on Coding and Import into UK law.

The consultation will run for a four-week period from until 7 April 2017.

The consultation is your opportunity to tell DH how you think the amendment Regulations will affect you and consists of two sections:

1. Coding: this section focuses on EU Directive 2015/565/EC.
This Directive sets out technical requirements for the coding of human tissues and cells through the implementation of the Single European Code (SEC)

2. Import: this section focuses on EU Directive 2015/566/EC.
This Directive sets out the procedures for verifying the equivalent standards of quality and safety of imported tissues and cells.

DH's consultation document explains the articles of the Directives and how it is planned they will work. These explanations are followed by a series of questions about how the Directives will work in practice. Your answers will help DH to understand the practical impact of the Directives and how they will affect your work on a day-to-day basis. 

As part of this consultation, the HTA are also welcoming any feedback or comments regarding our draft guidance document aimed at establishments in the human application sector.

Our guidance contains key information on how the Directives will affect particular groups of establishments, such as:

  • private tissue banks;
  • commercial importers and distributors;
  • registries and HSC transplant centres;
  • tissue banks; and
  • establishments procuring for ATMP manufacture. 

The guidance is currently in draft format, pending the feedback we receive from the consultation. If you have any comments on its content, you can include them as part of your response at the end of the DH consultation.  Alternatively, you are welcome to email us with any feedback you may have.

To respond to the consultation, please follow this link.

You can also find more information about the consultation on the HTA website.

Coding and Import webinars

We will hold two webinars during the DH consultation period. The webinars will focus on how the Directives will affect those in the human application sector, as well as provide an opportunity for establishments to ask us any questions regarding our draft guidance.

The webinars have been scheduled as follows:
  • Wednesday 22 March:  3-4pm GMT
  • Friday 31 March:   10:30 - 11:30am GMT 
You can register for the webinars via the HTA webinar homepage.
 

Post mortem sector news

Resources for health professionals caring for women and couples with pregnancy loss


The Miscarriage Association have developed a suite of learning resources for professionals, informed by women and their partners who have experienced miscarriage, ectopic pregnancy or molar pregnancy, and by health professionals who care for patients with pregnancy loss.

The six sets of materials are designed respectively for A&E staff, ambulance crews, GPs and, perhaps most relevant, for anyone who does early pregnancy scanning, including talking to patients about management and disposal.

You can find these materials on their website.

Research news

The UKCRC Tissue Directory


The UKCRC Tissue Directory was launched last year with the vision of increasing the visibility of existing research resources in the UK.  The Directory of Biobanks now has over 100 resources registered and an improved sample search function.

The UK Ethics Committee Authority (UKECA) have made registration in the UKCRC Tissue Directory a condition of the Research Ethics Committee (REC) favourable opinion for research tissue banks (RTB). This means anyone applying or renewing their RTB ethics will be required to register their collections on the directory. You can read more on this here.

Please visit the UKCRC website or get in touch with them for more information.

Organ donation and transplantation news

Guidance on consent for transplantation research where donors are deceased


To bring clarity to the issues surrounding consent under the Human Tissue Act 2004 for research relating to transplantation where donors are deceased, we have produced guidance and a supporting flowchart. These apply in England, Wales and Northern Ireland, and are not affected by the Human Transplantation (Wales) Act 2013.

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