National Institute for Biological Standards and Control
Animal Welfare and Ethics Review Body
Minutes of a meeting held on Tuesday 06 October at 2:00 pm
Present:
Apologies:
REDACTED (BSD Head; NACWO)REDACTED(Lay)REDACTED (Chair)REDACTED (primary NVS)REDACTED (NACWO)REDACTED (NTCO)REDACTED (Scientist)REDACTED(NACWO)REDACTED (NIO)REDACTED (Scientist)
REDACTED (HOLC)REDACTED (NACWO)REDACTED (Stats)REDACTED (Lay)
REDACTED (Secretariat, PPL Holder)
In attendance:
REDACTED Item 4REDACTED Item 5
Made available for reference and confirmed as accurate. Action 20-14: Chair to organise for approved Minutes from August to be signed by the Director.
(a) 19-48: Carried forward: Secretariat raised the ‘what to expect from AWERB’ document for discussion at SMT and (Incoming) Chair presented finalised document – action closed.
A comment was raised during SMT regarding the ‘what to expect from AWERB’ document and whether some flexibility could be captured in exceptional circumstances. AWERB agreed that the review process is robust and has recently, for the new COVID PPL application, illustrated that the process can be expedited when required. The initial submitted draft of this PPL also received positive feedback from the HO. Future PPL applicants may benefit from suggested revisions to the text rather than a question-based approach, and the standardisation of tables of administration for example, could assist further.
(b) 20-07: Carried forward: (Incoming) Chair and PELH will send an email to NIBSC all users as a reminder of the importance of the AGM meeting but which was cancelled due to the pandemic. This will be scheduled for when a face to face meeting is possible.
(c) 20-08: Updated retrospective assessment submitted to HO – action closed.
(d) 20-09: Carried forward: NACWO representative on Concordat group will raise the excellent 3Rs work undertaken to date under PPL PE12BE3A7 as per discussion during Mid-term review.
(e) 20-10: Staffing issues escalated to SMT via ABS Head – action closed.
(f) 20-11: Training course notes shared – action closed.
(g) 20-12: Carried forward: (Incoming) Chair to consider whether an additional PPL holder is required. This will be added as an agenda item for further discussion during the next meeting.
(h) 20-13: (Outgoing) Chairsent an email to PELH ahead of SMT meeting regarding his report on key successes and challenges from period in post. This was followed up by a joint letter to PELH from both Outgoing and Incoming Chair and meetings have been scheduled to discuss further. 20-14: (Incoming) Chair to provide a summary of this meeting and a copy of the report to AWERB.
The PPL Holder presented an oral update against the report. Highlights:
- PPL broadly covers safety and effectiveness of products through active immunisation and antitoxins with a recent emphasis on immunogenicity rather than infection models. Following the refinement of the immunisation protocols, an increased number of infection studies with the aim to compare the in vivo infection models with in vitro infection assays are due to be completed. These aim to validate the in vitro assay thereby supporting the replacement of in vivo assays in the future.
- Some unexpected adverse effects were seen and refinements made as a result. Close animal monitoring, detailed BSD record keeping, and thorough internal investigations have resulted in improved welfare.
- Q&A
o Q: has the slowdown of the adverse effects recorded during the reported period reflected refinements made and that problems with adjuvanticity were resolved. A: agreed
- AWERB members agreed that this was a very clearly written and detailed mid-term review.
- The PPL broadly ensures that biological medicines are both safe and effective and consists of 8 protocols. Overall, a lower number of animals has been used to date than originally anticipated with very limited if no usage reported under 3 of the protocols. Titremax has now replaced Freuds adjuvant. It is anticipated that some protocols will not be utilised between now and the PPL expiry, including the human mouse transfer which is now covered by a separate humanised mouse PPL and the EPO assay which can now be performed in vitro.
- Action 20-15: PPL holder to add species used to protocol 5, clarify that alpacas are rehomed after use under protocol 4 and confirm that only Titremax has been used.
- This is now the only PPL that allows NHPs to be bled since the other vaccine strategies licence has expired. Further discussions are required including whether we should have a standalone PPL specifically for this and to cover different purposes; whether blood could be purchased instead or the feasibility of collecting and storing a bank of blood to cover future requirements.
The IAT, along with other bodies, released this document in August as a starting point to enable AWERBs to review and reflect on the period leading up to, during and after lockdown to capture what could have been done better or differently. Although not mandated by the HO, we anticipate that Inspectors will be encouraging AWERBs to undertake a review and there may be opportunities for discussions to be held via AWERB Hubs.
The HOLC distributed the document to all BSD staff and comments requested via email or anonymously via the BSD suggestion box. Two responses were received by the deadline and were included in the report shared with AWERB. An additional response was received after the deadline and for that reason alone, was too late to include in the already distributed version. Comments from AWERB included:
- The decisions made before and during the current pandemic have been effective, with no significant areas for improvement raised to date.
- Morale amongst BSD staff is low through a combination of factors including gross understaffing, staff feeling unappreciated (e.g. the COA allowance review has been ongoing for in excess of two years), and lack of investment in infrastructure (machinery and building maintenance). The split team working since March has brought its own challenges and there is a lack of BSD representation at a higher level.
- BSD were already understaffed before the pandemic with no headroom for sickness and absences and the proposed COVID work schedules were too extensive and had to be aligned with staff resources. This higher containment work is extremely labour intensive and complex, and staff are feeling rushed due to other work demands. Recruitment is ongoing but has been slow and the accumulating backlog of work will need to be started at some point, so the next 18 months is expected to be extremely difficult.
- A suggestion was made as to whether the connection between research grants and BSD staff requirements could be better aligned. Could a mechanism be introduced to look at the time and workload of new grant applications and what impact this could have on BSD?
- Should AWERB refuse any future PPL applications if adequate staffing is not available and could the PELH and Head of ABS be encouraged to visit BSD annually?
Action 20-16: Chair to take all comments on board and will discuss with PELH.
– The PPL overview document highlighted that 2 further mid-term reviews are due this year along with 1 retrospective assessment and it is intended for these to be discussed during the next AWERB meeting. A total of 5 PPLs expire in 2021, the first of which is in January and which will be ‘renewed’, but there is no immediate urgency to have this in place (no animals are being kept on this PPL and COVID work is currently taking priority).
– Since our last AWERB meeting 1 PPL application, 2 PPL amendments and 1 PIL amendment have been submitted to the HO.
– Visits are now made at least 1/week and communication remains good.
– No specific animal welfare concerns were raised. The tamarin colony continues to be monitored due to babies being lost and new breeding pairs may need to be identified which takes time. The implantation of transponders I/P in both tamarins and marmosets for the COVID work is under investigation. Adjuvant usage in rabbits is also being discussed.
Deferred to next meeting
Update report provided.
Thanks were extended to the NTCO for his contribution to AWERB business over the years and AWERB members wished him the best of luck in his new role.
The meeting concluded at 16:00 pm.
END
These Minutes have been viewed and approved by the Establishment Licence Holder (Director of NIBSC).
Signature: REDACTED
Date: 11th June 2021