Prof Janet Bainbridge
Prof David Baulcombe
Dr John Carr
Dr Martin Carrier
Dr Peter Coyle
Prof Ernest Gould
Dr Penny Hirsch
Dr Keith Howard
Dr David Lewis
Dr Philip Minor
Mr Bob Osborne
Dr Brian Robertson
Dr Peter Searle
Dr Michael Skinner
Dr Paul Logan
Mrs Diane Fox-Purday
Dr Jonathan Gawn
Mrs Diane Tsavalos
Mrs Kären Clayton (observing as HSE Head of Unit)
Dr Androulla Gilliland (DEFRA)
Mr Paul Manser (DEFRA)
Ms Sarah Senior (HSE)
Dr Maggie Lacey (HSENI)
Mr Robert Parkes (HSE)
Dr Gary Burns
Prof Martin Gore
Dr Sue Mayer
Prof Peter Williams
1 The Chair welcomed everyone, particularly Mrs Kären Clayton, head of HSE Biological Agents Unit and Mr Robert Parkes, of HSE Policy Branch.
2 Prof Peter Williams regrets that he will not be renewing his membership in 2007 owing to increasing pressures of work. The Chair will send a letter of thanks on behalf of the Committee and the HSE Chief Scientist will send a letter of thanks also.
3 As the guest speaker will not be arriving until after lunch and there is a lot to cover, the agenda will be reordered.
4 The minutes were accepted as a true and accurate record of proceedings.
5 Canine gene therapy work mentioned in the previous meeting has not gone ahead because the patient was too ill to undergo treatment.
6 The letter to Genzyme regarding the AdHIF trial was agreed with members and sent out, although Genzyme appear to have ignored Committee advice and abandoned the multi-centre trial. The company intends to notify the work as nine separate applications. Prof Lewis’s site has been approached to carry out the work at CL1, but has persuaded the company to do the work at CL2.
7 Policy work on Exclusion of safe GMMs is ongoing and will be raised with the EC.
8 Inconsistencies in clinical trials work between member states is being looked into by the EC.
9 The Secretariat is confident that matters of concern raised over Dengue Fever work in a previous meeting are adequately addressed in the reverse genetics section of the Compendium.
10 The Chair reminded members that today was the final opportunity to comment on the Compendium. The Secretariat said that it had been favourably received by the consultees with only one centre indicating that they preferred the original version.
11 For each of the parts of the Compendium, the Secretariat outlined the most significant and repetitive comments.
12 The Committee was content with proposed suggestions and amendments to the guidance. All agreed that the position on lentiviral vectors was still unsatisfactory.
13 The Committee agreed on removing specific guidance and using the Dutch model instead.
14 The Chair outlined the reason for this agenda item, ie it is a CL4 activity for which partial consent has already been granted. However, a number of significant matters need to be discussed before a full consent is issued.
15 The guest speaker gave a detailed presentation outlining the structure and remit of the group undertaking the work, an overview of lyssaviruses, in particular European Bat Lyssaviruses (EBLV) and worker protection rationale.
16 Members went on to ask reason behind the decision to use 5.0I.U. of vaccine and if antiviral and interferon therapy formed part of the protection regime for a worker exposed to phylogroup 2. The guest speaker stated that there are no plans to work on any from PG2, especially West Caucasian Bat Virus.
17 The Secretariat explained what their next course of action would be and the Committee raised no concerns. Professor Gould suggested looking at growth curves prior to starting in vivo work on the more dangerous viruses and also testing the potency of the available vaccine on EBLV.
18 The Secretariat explained that the laboratory is more like a DEFRA Level 4 lab than ACDP CL4, but still adequate and they have a derogation for their autoclave. The Competent Authority proposes granting of step-wise consent on the receipt of data from in vitro studies and only intends to limit the work to PG1 species for the foreseeable future. The guest speaker already has the required data available and Drs Howard, Minor and Skinner suggested some additional studies and systems that may be considered.
19 The Secretariat stated that HSE will discuss the matter further with the dutyholder and invited the guest speaker to return to a future Committee meeting to give an update on the in vitro work.
20 The Committee agreed that the work should be undertaken at ACDP4 given the risk to the worker.
21 It was agreed at the previous meeting that the next open meeting will be used as a platform to launch the new Compendium which will be published on-line either shortly before or on the day (1/2/07). HSE Chief Executive has agreed to open the meeting and HSE’s Chief Scientist has agreed to talk about what Government requires of Scientific Advisory Committees. The Chair would introduce the SACGM and its terms of reference and the Secretariat would describe the background to the Contained Use Regulations and Dr Gawn would describe his experiences of the process.
22 All agreed that the most convenient way to organise the meeting was for a spokesperson from each Compendium working group to give a 15-minute presentation. The Secretariat volunteered to transcribe presentations into a consistent format.
Action: Working group spokespersons to forward presentations to the Secretariat.
23 There was no other business.
The Chair thanked everyone for their attendance and drew the meeting to a close.
