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HTA Stakeholder and Fees Group meeting agenda
Date 21 October 2019 Time 2.00pm – 4.00pm
Venue Boardrooms 1&2 HTA office 151 Buckingham Palace Road London
Protective Marking
OFFICAL
1. Welcome and introductions Oral
2. Minutes actions and matters arising Oral
3. Licensing and fees review Paper (1/19)
4. Deemed consent for organ donation in England Paper (2/19)
5. Brexit update Oral
6. Updated guidance for Post Mortem licensing standards Oral
7. Digital communications strategy Paper (3/19)
8. Horizon scanning Oral – all
9. Proposed items for next meeting Oral
10. Any other business and date for next meeting Oral
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Minutes of the eleventh HTA Stakeholder and Fees Group meeting
Date 29 May 2019
Venue 110 Rochester Row London SW1P 1JP
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OFFICIAL
Present
Stakeholders Fidelma Murphy (FM), NHS Blood & Transplant Kay Wadey (KW), Public representative Claire Smith (CS), Anatomy Associations Advisory Committee
Wendy Birch (WB), Institute of Anatomical Sciences Sarah Dickson (SD), MRC Regulatory Support Centre (by phone) Emma Radway-Bright (ERB), Anthony Nolan Dr Kamal Ahmed (KA), HCA Healthcare Ben Charles (BC), Biovault (by phone) Veronica English (VE), BMA Philip Luthert (PL), UCL (by phone)
HTA David Thomson (DT), Head of Business Technology, Maria-Paulina Socarras (MPS), Stakeholder Engagement Manager – minutes, Matthew Silk (MS), Head of Communications, Nima Sharma (NS), Board Secretary – observing, Nicolette Harrison (ANH), Director of Regulatory Delivery, Dr Philip Bergin (PB), Regulation Manager, Dr Robert Watson (RW), Head of Regulation, Dr Ruth Joyce (RJ), Senior Policy Manager
Chair and Board Members Bill Horne (BH), HTA Authority Member – SFG Chair
Apologies
Ann Russell, Independent Cancer Patients’ Voice
Kirstin Goldring, AstraZeneca
Rachel Maxwell, Belfast Health & Social Care Trust
Hirasine Sengomona, Anthony Nolan
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Item 1 – Welcome and introductions
1. The Chair (BH) welcomed Stakeholder and Fees Group (SFG) members tothe meeting.
2. BH welcomed a new member to the group, Dr Philip Luthert from UniversityCollege London. Sarah Rappaport from the Wellcome Trust has steppeddown from SFG; BH extended his thanks for her contributions to the group.
3. Prof. Dame Sally Macintyre’s term has ended as an HTA Authority Member,and therefore she will no longer be joining SFG meetings.
4. Apologies were given to attendees participating via telephone as there wasconfusion with the host venue regarding audio equipment.
Item 2 – Minutes and matters arising
5. Minutes of the meeting of the 22 October 2018 were reviewed and agreed.
6. The progress made against each action is summarised in the table below:
Stakeholder Group Actions Progress
SD to forward any useful information for the Research sector that can be shared in the HTA newsletter with MPS.
Action complete. SD has forwarded over items to be included in the May professional enewsletter.
Regarding the GDPR. Members to forward any examples of difficulties in this area for consideration by HTA.
Action complete. No items forwarded or further issues raised.
RS to build in discussion on changes to fees structure with SFG members as part of the early 2019 consultation.
Action complete. Paper on Fees tabled for this May 2019 meeting.
7. VE raised issues around the exhibition hosted at the NEC, Birmingham, calledBody Worlds, specifically that there is a disparity in the Human Tissue Actbetween consent requirements for imported and domestic bodies.
8. MS confirmed that the HTA has raised this issue with their sponsor team at theDepartment of Health and Social Care (DHSC), with the last HTA Chair Nicola(now Baroness) Blackwood having written to them to raise this as an ongoingconcern and potential risk to public confidence.
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9. The HTA licensed the Real Bodies exhibition as it conformed to the licensing standards, but advised the company running the event that they proceeded at risk, based on negative public reactions to the exhibit and origins of the bodies.
Item 3 – Deemed consent update
10. RJ led a discussion on the project to amend HTA Code of Practice F in light of the introduction of deemed consent for organ and tissue donation in England.
11. The HTA have divided the Code into two sections: living donation and deceased donation. There will be a consultation on revisions to part two of the Code regarding deceased donation.
12. BH asked that we share the link to the consultation with SFG members on
launch.
13. CS fed back that there were concerns in the Anatomy sector regarding deemed consent and body donation, in that some potential body donors believe that deemed consent will apply to body donation as well as organ donation.
14. WB said she thinks this also applies to taphonomy, with people believing their
donated body could be used for this purpose, which risks people opting out to avoid this for no reason.
15. FM said that she would take this back to the NHS Blood and Transplant
communications campaign team.
16. RJ raised the point that the HTA will also be updating its public guide to code F, so providing clarity on this matter could form part of that work.
17. VE asked how the new code will differ from the Welsh Code. BH highlighted that
health is a devolved matter in Wales, and so there may be some divergence between the codes, but the HTA would obviously be seeking to avoid unnecessary divergence.
ACTION: MPS to send link to consultation to SFG members when it launches. ACTION: HTA to ensure the update to public code F includes some clarification on what deemed consent does not cover.
Item 4 – Licensing and fees project
18. ANH led a discussion on the licensing and fees project proposals.
19. ANH explained that the project has been commissioned to explore areas where the licensing and fees structure may no longer be representative of the
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regulatory work undertaken by the HTA. The project group will consider aspects of both the current licensing and fees structures, with the aim of exploring potential changes that will realign both with the regulatory work undertaken by the HTA across sectors and in relation to licensable activities.
20. A major part of the project is to evaluate how our licensing framework works with the sectors that have seen changes over the years, as well as the way healthcare is delivered in the UK. For example, the HTA have witnessed an increase in the number of hub and satellites sites that are licensed.
21. FM noted that NHSBT would require early engagement with regards to any license and fees changes as it would have a significant impact on their organisation. FM also noted that it would be useful to see what kind data we are using to gather information with regards to fees remodelling. ACTION: HTA to ensure that NHSBT have early engagement with regards to any licensing and fees proposals.
22. ANH explained that the Finance Team are looking at a broad data set to inform their initial proposals, including licensing data, regulatory data (which includes the number of DIs and satellites sites). The HTA will be looking at the fundamental framework of what a licence is and other data that gives an indication of what effort the HTA puts into a particular sector.
23. CS stated that the HTA should look to strike a balance between the duty to
provide advice and guidance and fee payment. KA agreed with this point and noted that the HTA should also factor in that shortfalls identified on inspection often lead to costs incurred to the establishment.
24. FM queried whether the HTA would be looking at how other regulators charge for
licence fees. ANH responded that the HTA will be.
25. CS stated that there is difference between DI and PD workloads. It is currently not clear how the HTA know if there is a change of PD. MS responded that the HTA are keen to ensure that it has up to date licence contacts and will be looking to ask for updated PD contact details in this year’s round of compliance updates.
26. ANH reassured the group that the HTA are committed to SFG engagement with
regards to this piece of work and will be reporting the group’s feedback at the July Authority meeting.
Item 5 – Digital transformation project 16. DT provided the group with an update on the HTA digital transformation project.
17. The HTA have identified a number of areas that it would like to make changes to
in order to operate in a more sustainable manner. This involves looking at how
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the organisation recruits new staff from a wider pool of candidates and investing in training and development for current staff.
18. In order to achieve this, the HTA will need to review its IT and digital infrastructure to better support remote working for members of staff.
19. Information and data is also a key element of this work. This will mean looking at
how information can be submitted to the HTA by its stakeholders and licensed establishment contacts, and how the HTA can target its regulatory activity using the data it has to look at risk across the sectors.
20. BH noted that this will be a multi-year programme that will introduce significant
change to the way the HTA operates. Given that the HTA has limited funding, the organisation will have to identify priority areas with regards to this project. Ultimately, this project will seek to provide HTA stakeholders with improved regulatory oversight of their activities.
21. SD queried whether the HTA will be looking at other organisations that will be
undertaking similar changes. DT assured that the HTA has been.
Item 6 – Developing learning resources for licensed establishments 22. MPS, MS and PB led the group through a discussion and update on current
activity with developing learning resources for those working at HTA licensed establishments.
23. MPS provided the group with an update on the work undertaken by the HTA Licensed Establishment Engagement Programme (LEEP) and the recently launched online tests based on HTA legislation.
24. So far, the HTA has received just under 1200 responses on the tests in total and
the data from the test scores will help the HTA understand whether there is difficulty or lack of clarity on a specific area or topic. The most popular test has been the HT Act consent and licensing test, which has generated over 450 responses in under two months.
25. To ensure that the tests are being viewed as widely as possible, MPS has
engaged with various sector organisations to share the tests through their external networks.
26. CS gave positive feedback on the tests and stated that the Anatomy sector have
found them very useful.
27. MS led the group through a discussion on the project that is looking at establishment’s understanding of the HTA’s licensing requirements. The HTA are looking to make the requirements clearer on existing channels, such as the website; making it more interactive and user-friendly.
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28. The HTA comms team will be working with LEEP to develop new clear and accessible resources on the licensing requirements.
29. PB, who is a member of LEEP, provided an update on his work looking into the
possibility of offering licensed establishments a series of interactive webinars on core HTA topics.
30. PB sought the group’s views on whether the HTA should offer a series of single
session seminars, expanding on the information contained in the online tests or lengthier subject-based workshops that combine several adjoining topics into one session.
31. SFG members agreed that webinars are a very worthwhile approach as past
HTA webinars have provided useful ongoing resources that they can refer to.
32. VE queried whether the HTA has considered offering CPD accreditation for any forthcoming events or webinars as it would encourage more people to get involved. PB stated that the HTA have not investigated this as yet, because the organisation has only started exploring whether or not webinars are feasible.
33. SFG members concluded that bite-size webinar sessions would be a better
approach than longer sessions as it would be useful to complement them with taking the online tests. It would also give people the choice over which core topics they would like more information on.
ACTION: HTA to share list of suggested webinar topics once they have been agreed internally.
34. CS stated that the Anatomy sector would be keen to feedback into the
development of webinars and are willing to support the HTA in any way possible to achieve them.
35. SD mentioned that the MRC generate lots of online learning resources for the
Research sector and have recently developed an online toolkit on research using human tissue which was developed with the HRA.
ACTION: SD to share details of the MRC’s online resources and toolkit with PB and MPS.
36. BH concluded that the HTA often receives enquiries from professionals at
licensed establishments about providing. This would require a significant resource commitment that the HTA cannot, at this time, prioritise.
Item 6 – EU exit update 36. MS updated the group on recent communications shared by the HTA on EU exit
‘no deal’ preparations. He sought feedback from the group on whether they
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found the information provided clear and sufficient.
37. ERB stated that Anthony Nolan felt the HTA had provided the right level of information and that they were able to find the information they needed.
38. FM agreed with this point and concluded that it is difficult to determine what level of information they require as an organisation given that the political situation is very unclear.
Item 7 – Update on the implementation of the recommendations of the HTA’s Human Application (HA) risk project 39. RW led the group through a discussion on the HA risk project which is looking at
whether the HTA have adequate oversight over the sector. The scoping phase for the project began over a year ago and the HTA gave a presentation on the project’s key areas at the 2017 Public Authority meeting.
40. RW explained that the project is looking at three core areas: TPAs, PPDs, and inspections. Establishments are unlikely to see significant changes as a result of this project, but the HTA will be seeking information from its stakeholders in order to tailor these three key areas, especially inspections.
41. At the moment, the HTA have a duty to inspect HA establishments once every
two years. The project has been looking at whether there is scope to tailor this approach in order to make sure inspections are risk based. It has also been looking at how the HTA can link inspections to SAEARs reporting.
42. RW stated that the project will look at whether the current two-year cycle works
well, or whether there is value in undertaking short notice or unannounced inspections.
43. With PPDs, the HTA are looking to improve their internal systems to ensure they
are robust and submissions can be approved efficiently. For example, RW’s team are looking at tissue type benchmarks as part of this.
44. RW reiterated that it is fundamental that the HA sector are engaged with this
project and he sought views from the group on whether there are any concerns.
45. KA queried whether the outcomes of this project would have any effect on licence fees. RW responded that the HTA will look to incorporate the HA risk work into the fees model.
46. A discussion took place on the current two-year inspection cycle. RW admitted
that the HTA are wrestling with what a new approach to inspections for the HA sector would look like. Though the HTA do not have control over changing the two-year requirement, the organisation does have control over how intensive the inspections can be. For example, reasonably compliant establishments may not require a full three-day inspection.
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47. FM agreed that a more flexible approach to inspections would be favourable to establishments, and ultimately patients too.
Item 8 – Update on the joint HRA/HTA work in response to the public dialogue on ‘Consent to use human tissue and linked health data in health research’ 48. ANH updated the group on the HRA’s/HTA’s plans for joint work arising from the
public dialogue project.
49. The work began in earnest two-years ago and it entailed direct engagement with the public through focus groups. The HTA and HRA jointly published the project findings a year ago.
50. ANH explained that the project brought about a good deal of discussion and interest on the role of access committees and dynamic consent. She highlighted that while the HTA and HRA are not responsible for personal data, there was difficulty in explaining the complexities of levels of anonymisation to the public.
51. VE asked whether the HTA had come across the Patient Data Programme developed by the Wellcome Trust as part of this project. ANH stated that she would pass this information along to Chris Birkett who is the HTA lead on the project.
52. A discussion took place on the issue of broad consent and GDPR. Many people are not clear about the use of data with regards to the storage of tissue.
53. SD stated that this project highlights discussion with the public, however it would
be useful to know what they feel the priority areas are.
54. VE added that there is a lack of general information on access committees and research ethics committees (RECs) and how they can engender trust from members of the public. She queried where RECs feature at all within the project and what safeguards are in place for the public. Most of the public will not be aware of what RECs are or do, which is something to bear in mind.
55. ANH thanked VE for her comments and stated that HTA Authority Member Andy
Hall has a long standing interest in the use of tissue for research and is aware of the project. She stated that will ensure that Chris Birkett talks to Andy about this issue.
Item 7 – Horizon scanning 56. BH introduced the horizon scanning agenda item to SFG members. The
purpose of this item is for the group to share emerging policy issues for discussion amongst members. There are two policy and development areas that the HTA have been focussing on.
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i. Organ perfusion devices
RJ updated the group on the work the HTA have undertaken on devices that are being used to deliver treatment to organs prior to implantation. The use of these devices has increasingly become more routine, rather than used as part of research. The HTA have developed guidance on the use of these devices, which is pending sign off by the HTA’s Senior Management Team following feedback from the Authority.
ii. Taphonomy
Over the last few years the HTA have noticed a rising interest in the media in relation to human taphonomy facilities (HTF), more commonly referred to as “body farms”. The HTA’s line on this area has been consistent across this period, in that it is not something currently within the HTA’s remit (i.e. not listed under the Act as a “scheduled purpose”), but the HTA would expect to see bodies treated with the same respect and dignity as in other areas that use human bodies and body parts in their work. The HTA will continue to monitor interest and coverage of this in the UK, and continue to work with colleagues and stakeholders to provide advice and guidance in this area.
57. WB stated that she is currently collaborating on a project with the ARISTA
taphonomic facility in Amsterdam.
58. VE updated the group on the BMA’s policy work involving consent and the retention of blocks and slides. The BMA made a recommendation on this area in the McCracken review when it took place, but wanted to flag to the HTA that this issue has resurfaced. The BMA are concerned about the loss of good samples due to the lack of consent in place. This is due to be discussed further at the BMA’s annual meeting in Belfast.
59. VE also shared that the BMA are looking at unethical organ harvesting from China. The tribunal report was published in June and there are suggestions to prohibit transport to China for transplants. ANH stated that the HTA are aware of these issues, however they lay outside of the organisation’s remit.
60. ERB stated that Anthony Nolan are looking into new therapies involving CAR T-
cells. They are having difficulties understanding where the HTA requirements begin and end. RW suggested that ERB contact the Regulatory Advice Service for Regenerative Medicine (RASRM) for guidance as she will receive a joint response from all the regulators.
ACTION: MPS to send RASRM contact information to ERB.
Item 8 – Any other business 44. BH informed the group that the HTA conference will be taking place on 6
November and further details of the event will be shared with SFG members in due course.
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45. BH also shared that the HTA blog will be launched the day after the meeting.
ANH has submitted the HTA’s first blog and it will be covering her reflections on the HTA’s role and how the organisation came into being.
46. BH encouraged SFG members to read the blog and provide feedback. The HTA
are also welcoming guest blogs and any suggestions for interesting topics.
47. FM stated that she often reads MHRA blogs, which are short snippets that work well.
48. MS updated the group on the upcoming launch of the Post Mortem shared
learning publication, which will cover a contextual analysis of inspection findings, HTARI submissions, and submissions from compliance reports since 2017.
Item 13 – Proposed items for next meeting 45. The following items will be added to the agenda for the next meeting in May
2019:
• Licensing and fees project update • Deemed consent and Code F update. • EU exit • Update on changes to the EUTCD.
46. Additional items welcome. Summary of actions for the next meeting: Stakeholder Group Actions Action
Responsibility Due
1. ACTION: MPS to send link of Code F consultation to SFG members when it launches.
MPS June 2019
2. ACTION: HTA to ensure the update to public code F includes some clarification on what deemed consent does not cover.
MPS/MS Spring 2020
3. HTA to ensure that NHSBT have early engagement with regards to any licensing and fees proposals.
RS/MA Oct 2019
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Stakeholder Group Actions Action Responsibility
Due
4. HTA to share list of suggested webinar topics once they have been agreed internally.
MPS/PB Oct 2019
5. SD to share details of the MRC’s online resources and toolkit with PB and MPS.
SD Oct 2019
6. MPS to send RASRM contact information to ERB.
MPS Oct 2019
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Stakeholder and Fees Group paper
Date 14 October 2019 Author Richard Sydee
Agenda Item
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Official
Licensing and fees review
Purpose of paper
1. To update the Stakeholder and Fees Group (SFG) with the progress of the
Licencing and Fee review.
Background
2. Previous discussions with SFG highlighted our intention to undertake a review
the current fee structure. This was to consider what, if any, changes might be
necessary to ensure that fee recovery remains aligned to regulatory activity;
and in addition whether emerging areas of activity should be considered for
additional fee recovery. The work review set out to consider six work
packages:
Fees Structure
Satellites
Licensed activities
Third Party Agreements
Temporary Licences
Return to Compliance
3. Internal consultations with regulatory teams, the HTA executive and Authority
have taken place over the summer to consider the current approach to fees and
licensing and potential options for revisions to fees against the identified areas.
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Findings
4. The project group’s overall conclusion was that the current structure remains a
sound basis for fee recovery. Although it was accepted that the model could
benefit from some minor amendment to the fundamental principles of charging
by sector, satellite and activity to retain broad alignment with our regulatory
effort.
5. In relation to the specific work packages the groups conclusions are
summarised below:
Fees structure. That the weighting between the main licence fee and
activity fee levels would benefit from some minor realignment to fit our
current understanding of regulatory workload.
o It was felt that the balance between a main licence and activities was
broadly right, but that activities themselves might not reflect current
resource consumption.
o It was suggested that the current charges for import and processing
within the HA sector did not necessarily reflect the regulatory effort
and should be reviewed.
Satellite fees. The approach to satellite fees should also reflect their
activity/complexity and not be based solely on the number of satellites
held under a main licence.
o The distinction between a main and satellite site was established by
the HTA and is not legislative. Overall it was agreed that there are
some demonstrable regulatory benefits from the shared governance
systems of Main and Satellite sites. Review groups felt that the
current numerical distinction for charging did not necessarily reflect
regulatory effort and some consideration of the complexity of a
satellite would be a better basis for income recovery. Moving forward
there was some support for moving away from the Main/Satellite
distinction towards linked licenses – but this would need considerable
effort in terms change of approach and systems.
Third Party Agreements. It was agreed that the HTA should undertake
more work to consider recovering fees related to Third Party Agreements
(TPAs).
o The nature and volume of agreements held by establishments meant
this was a complex discussion and it was agreed that we had
insufficient data available to consider introducing charges at this time.
Moving forward we would need to consider how we should regulate
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TPAs, the different arrangements and organisations involved and if
they can be grouped or categorised in any meaningful way.
Licensed activities. This work package considered if the activities in
each sector remains relevant and whether new activities should be
introduced.
o The group considered the option of charging for Preparation Process
Dossiers (PPDs) on a case by case basis. It was felt that although
PPDs can be burdensome that the option to charge on application
would potentially result in a higher expectation in terms of assistance
and turnaround time, as well as undermine the current level of
charging for the activity of processing on an annual licence. On
balance it was felt that an adjustment to the weighting of the activity
charge for processing would be a better option than the introduction
of a new charge
Consider amending the fees structure for Research, Anatomy and Public
Display sectors to introduce a main fee and activity fees as currently
operated in the HA and PM sectors.
o Although this was felt to be a good idea in principle, there was limited
benefit to licensed establishments and the HTA of adopting this
recommendation. There would be little impact on overall fees
charged to establishments and, save a uniformity in approach for our
fees model, would not result in any administrative efficiency for the
HTA
Temporary licenses. To introduce temporary licence fees with 3 and 6
month options to avoid annual fees and refunds.
o It was felt that this was a good idea. This would require little
amendment to the existing fee model and provide a more
proportionate approach to licensing for time bound activities and
reduce potential barriers to entry in the sectors we regulate
6. The work to consider charging for returning to compliance/charging for
advice/consultancy was not able to reach a consensus on the introduction of
charges at this time. It was agreed that significant work or advice is provided to
establishments that that does not strictly form part of the HTA’s regulatory
responsibilities or legal remit. However the working groups were concerned
about the reputational impact of such an approach, the potential perverse
incentives that might result from the HTA not seeming responsive to emerging
issues and the current perception of the HTA by its stakeholders of being a
helpful and approachable regulator.
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Recommendations
7. As a result of this work we wish to seek input on the following potential changes
in to the 2020/21 fee structure:
i. To introduce a new charge for complex satellites according to the
activities undertaken. This would facilitate a more appropriate recovery of
fees from licences that have “linked” two main sites to benefit from the
current satellite fees structure. It would differentiate for example between a
satellite used solely as a storage facility and a satellite that is a de-facto fully
operating centre (for example a satellite site used solely as a body store or
one undertaking a Post Mortem in the PM sector).
ii. We invite SFG to discuss whether the fees currently recovered reflects the
consumption of regulatory resource for satellites and whether this proposal
more appropriately reflects the sectors risk. The proposal would be to apply
a distinction between satellites as either Complex/Non Complex and apply
an additional charge accordingly. It was felt this could be distinguished
clearly in the PM sector (whether the satellite is undertakes PMs) and in the
HA sector (for satellites undertaking the activity of processing), although this
distinction of complexity within the HA sector was felt to be less clear cut.
iii. To review the weighting of the main licence/activity fees. Linked to the
above point, the main licence fee within the HA sector should be reduced
and with a proportionate increase in the cost of certain activities (Import and
processing).
iv. This is unlikely to result in substantial changes for most stakeholders but
better aligns fee recovery to regulatory effort and risk. SFG are invited to
consider the merits of this proposal.
v. Introduce a temporary licence. Calculate and publish a temporary licence
fee that includes both the application element and the fee for a fixed period
(3 or 6 months) allowing an establishment to make a one off payment for a
fixed term licence.
vi. Future work. For the area of TPAs it was felt significant additional work and
consultation would be required with stakeholders ahead of any licensing and
fees proposals. SFG is invited to propose representative stakeholders to
work with the HTA’s regulatory and policy teams to consider how this might
be applied.
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2020/21 fees
8. The work above has considered the modelling approach to fees recovery
and has deliberately avoided conflating proposals with the issue of the
annual fees review.
9. At present the HTA, along with other DHSC arm’s length bodies, awaits
confirmation of its 2020/21 funding grant. Once this has been confirmed the
HTA’s executive will consider the organisations budget position for the
2020/21 financial year and the level of any increase required in the total
amount of income to be recovered from licensed establishments.
10. It is hoped that we will be able to provide some indicative figures at the SFG
meeting.
Next Steps
11. The SFG is asked to consider the proposals and provide feedback on the
potential benefit and impacts on sectors or specific organisations. This
feedback will be provided to the HTA’s Audit Risk and Governance Committee
(ARAC) as part of their scrutiny of 2020/21 fee proposals.
12. Further to the discussion with the HTA’s ARAC agreed proposals will be
included in the overarching fee proposals that will be presented to the HTA
Authority meeting on 7 November 2019 for final approval. Final fees for the
2020/21 business year will be published in December in line with previous
timetables.
Stakeholder and Fees Group paper
Date 21 October 2019
Agenda item 4 Authors: Ruth Joyce / Jess Porter
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OFFICIAL
Deemed consent for organ donation in England
Purpose of paper
1. To provide the Stakeholder and Fees group with an update on progress withamendments to the HTA’s Codes of Practice in preparation for the introduction ofdeemed consent in England, which will come into force in spring 2020.
Decision-making to date
2. The Authority considered the proposed structure and initial draft of Code F –Donation of solid organs and tissue for transplantation at its meetings on 7February and 9 May 2019.
3. The draft Code was considered and approved by Secretary of State to allow forpublic consultation to begin.
Action required
4. SFG members are asked to note the content of this paper.
Background
Legislative background
5. The Organ Donation (Deemed Consent) Bill 2017-2019 received Royal Assenton 15 March 2019. The Organ Donation (Deemed Consent) Act 2019 (theDeemed Consent Act) will come into force in spring 2020.
6. The Deemed Consent Act will only apply to ‘permitted material’. The Departmentof Health and Social Care (DHSC) have drafted regulations which specify thematerial which will not be covered by deemed consent. The regulations largelycover ‘novel transplants’ and will be subject to Parliamentary approval.
7. The Deemed Consent Act places a duty on the HTA to provide practicalguidance for professionals working in the field of organ donation andtransplantation on deemed consent.
8. In addition, minor amendments will be required to Code of Practice A – GuidingPrinciples and the Fundamental Principle of Consent, and the Code of Practiceon the Human Transplantation (Wales) Act 2013 to reflect the changesintroduced by the Deemed Consent Act. Changes to both of these Codes are inprogress.
Progress of Deemed Consent project
9. A 12-week public consultation on Code F – aimed primarily at professionals –opened on 4 July 2019 and closed on 26 September 2019.
10. Throughout October, work has focused on analysing responses received duringthe consultation and drafting amends to the Code. Specialist advice on technicalissues and clinical accuracy sought from professionals including WelshTransplant colleagues, SNODs and intensivists. We continue to work closelywith DHSC policy and legal colleagues.
Preliminary feedback from the consultation
11. Analysis of feedback from the consultation has highlighted some areas whererevision has been required. This includes a desire for more clarity around therole of family, faith and cultural considerations, and questions specifically aboutprisoners and the issue of mental capacity.
12. Additionally, feedback demonstrated a desire to see more practical examples inthe Code which have been included.
Stakeholder engagement 13. We have participated in NHSBT’s Organ Donation Campaign Advisory Group
and Organ Donation Legislation Change meetings, to provide advice and guidance to NHSBT on their public awareness campaign.
14. In February 2019, the HTA hosted a roundtable event to seek stakeholder’s views, specifically on the role of the family, and faith and cultural considerations. There were representatives from multiple faith, secular and cultural groups in attendance.
15. The Chief Executive has held several face-to-face meetings with stakeholders to discuss the Code, to allow for the opportunity to receive and respond to feedback and answer any questions that have arisen.
16. In addition, we held a stakeholder workshop on 7 October 2019. The purpose of the workshop was to engage with frontline professionals who will be required to use the Code. Delegates included Specialist Nurses for Organ Donation (SNODs), Regional Managers, Specialist Requesters, Clinical Leads for Organ Donation (CLODs) and NHSBT tissue services.
Next steps 17. The consultation closed on the 26 September 2019. We received 75 complete
responses, a combination of Survey Monkey (online) responses and written responses sent directly to us.
18. We will continue to incorporate changes to Code F from the consultation responses we received over the coming months.
19. We are developing a consultation response document, which will explain the
changes we are making and will outline why other suggested amends have not been made.
20. The Code will require approval from the Authority and further legal review. The
Code will then be sent to DHSC colleagues to receive Ministerial and Parliamentary approval prior to deemed consent coming into force next spring.
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Stakeholder and Fees Group oral discussion
Date 21 October 2019
Agenda item 5
Protective Marking: OFFICIAL
Brexit update
Overview
Nicolette Harrison (Director of Regulation) will lead this item.
The discussion will cover:
Discussion at the meeting will focus on our communication activities. We will draw attention to how we are using our Brexit webpage and professional newsletters to keep stakeholders updated.
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Stakeholder and Fees Group oral discussion
Date 21 October 2019
Agenda item 6
Protective Marking: OFFICIAL
Updated guidance for Post Mortem licensing standards
Overview
Rachel Mogg (Head of Regulation for Post Mortem and Public Display sectors) will lead this item.
The discussion will cover:
• We are reviewing the guidance for PM sector licensing standards. This includesadditional guidance based on enquiries, incident reports and inspection findingsfrom our regulation of the sector and input from the Histopathology Working Group.
• The revised guidance is under review and we aim to publish this by April 2020.
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Protective Marking
OFFICIAL
Paper
Date 11 October 2019 Authors Jack Briggs (Digital Communications Manager) and Matthew Silk (Head of Communications)
Agenda item 7
Digital communications strategy
Purpose of paper
1. To update the group on our current digital channels.
2. To inform the group of our future digital engagement plans.
3. To gather feedback from the group on their experiences hearing from andengaging with the HTA online.
4. To gather feedback on our plans and any suggestions for improvement.
Background and context
5. The HTA’s website is our primary public facing information resource for ourstakeholders.
6. Like many public bodies, our website attempts to fulfil the needs of severaldifferent audiences, for example:
a. Members of the public;b. professionals working at our licensed establishments;c. organisations with an interest and/or involvement in our work; andd. Government stakeholders.
7. The website moved to a new and improved platform in 2015, with an updatedmenu system and design.
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8. Since 2006, the HTA website has had two major changes to its design andarchitecture (see Appendix A for the changes to the site over the last 13years), which is a typical iterative development cycle. However, during thistime, site content has increase.
9. To find out more about people’s experiences of navigating the website, inQuarter 1 of the 2017/18 business year we ran a website survey for eightweeks, and received 738 responses from visitors to the website:
a. 90% via an wesbite “pop-up” requestb. 4% from the public newsletterc. 3% from social media
10. Breakdown of respondents (n = 738):
a. 75% (551) from the publicb. 14% (107) from professionals at HTA-licensed establishments, within
this number most respondents were:i. PDs (37%)ii. DI’s (26%)
c. 3% (24) from “other” medical professionalsd. 8% (56) “other”
11. This informed a website content review project that completed in Q4 2018/19,and identified over 2000 live pages live on the site, and over 300 documentsfor review.
12. The rationalisation of content on the site intended to make it easier for visitorsto find a single source of up to date information.
13. Suggestions for improvement to the website were:
a. Make the navigation and design of the site simpler and easier to use.
b. Improve colours on the site so there is a greater contrast between theprofessional and public sections.
c. Improve the search function.
Current digital channels
14. The HTA focuses primarily on its digital channels to communicate importantinformation to licensed establishments. Our current digital channels are:
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Social Media a. Twitter b. Facebook c. LinkedIn d. YouTube e. HTA Blog
Website (which includes information on)
a. Guidance i. HTA Codes of Practice, Q&S Guide and the ODT Framework
Document ii. Public Guides to the Codes of Practice iii. Donation information for the public. iv. Policies and position statements. v. FAQs
b. Legislation c. Licensing information d. Find a medical school e. Enquiries f. HTA Portal – for establishments to submit data to the HTA (e.g.
compliance reports, incidents)
eNewsletters a. Professional (bi-monthly) b. Public (bi-monthly) c. Living Donation News (quarterly)
Feedback mechanisms 15. To gather feedback from the public and professionals, in an effort to measure
the effectiveness of our communications and seek out ways to improve, we currently use:
a. SurveyMonkey – online survey tool b. HTA Public Panel – an online group of public volunteers c. Poll Everywhere – live feedback software that presents results back
to the audience in real time d. Website “pop-up” windows – a little window that invites visitors to
the website to feedback on their experience e. Online enquiries webform – for contacting the HTA on a variety of
issues f. HTA Blog – below the line comments
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Future work
16. Website development: We are currently exploring a potential redevelopmentof the website. The options for this range from a simple change to how thewebsite is hosted to a complete redesign of the entire site.
17. New EU accessibility requirements: this will require the HTA to commissionan independent audit of our website, and act upon and improvements requiredto meet the new accessibility requirements from 23 September 2020.
18. End to security support: Our website’s software version will end fromNovember 2020 – this will require the HTA to take a decision on whether toaccept the risk, or invest in a new platform.
19. New Digital Communications strategy: since our new DigitalCommunications Manager started earlier this year, we have been looking athow we get best value out of our existing digital channels, and what we mightdo differently in the future. As part of this work, we are developing a newDigital Communications Strategy, to help steer our approach to how we useand develop these channels.
There will be more to follow on this once the work has progressed, and wewould very much like input from SFG members as this work develops.
Points for consideration/feedback from SFG
20. With our renewed focus on digital engagement, are we at risk of hearing froma select group of our audience? Are there any gaps?
21. Are there any channels we use that you do not think are effective, or have hada poor experience?
22. Similarly, are there any channels we do not use that you think could beeffective?
23. How do you prefer to hear from the HTA, what has worked well for you, orwhat do other public bodies do that you like?
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Appendix A – Evolution of the HTA website (images below from The National Archives)
August 2006
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November 2009
April 2015
1
Stakeholder and Fees Group oral discussion
Date 21 October 2019
Agenda item 8
Protective Marking: OFFICIAL
Horizon scanning Overview
This is a group item that will cover new HTA policy areas and an opportunity for members to tell us about their developments that we should be aware of. The discussion will cover: The aim of this item is to share and identify factors that might impact the HTA’s future policy and development work, such as:
• Review of the EUTCD (ANH)
• RCPath consultation on PM imaging (RM)
• Emergency mortuary licensing (RM)
• Funeral Director licensing (ANH)
As well as less tangible items that might affect our regulatory function, such as emerging news and public discussion, and developing science and technology relating to the use of human bodies, body parts, and tissue, including parliamentary discussions and industry matters.
