Minutes of the meeting held on 2 July 2003
Thu, 2 October 2003
On 2 July 2003, the Working Party held its meeting in the form of two subgroups. One subgroup met at the offices of the Nuffield Council on Bioethics. The minutes of this meeting are in Section A. The other subgroup undertook a fact finding meeting at the pharmaceutical company Pfizer. The minutes of this meeting are in Section B.
APOLOGIES
Dr Judy MacArthur Clarke, Professor Ian McConnell, Dr Lewis Smith, Professor John Spencer, Ms Michelle Thew
Section A - Minutes of the meeting held at the Nuffield Foundation on 2 July 2003
PRESENT
Professor Kenneth Boyd (Acting Chair)
Professor Allan Bradley FRS
Professor Steve Brown
Professor Grahame Bulfield CBE
Professor Maggy Jennings
Dr Mark Matfield
SECRETARIAT
Tor Lezemore, Nicola Perrin, Natalie Bartle
INTRODUCTION BY THE CHAIR
1 The Chair welcomed the members of the Working Party, outlined the schedule for the morning and reminded them that a sub-group was undertaking a fact finding meeting at the pharmaceutical company Pfizer, to familiarise themselves with the use of animals by the pharmaceutical industry.
MEMBERSHIP
2 There was discussion about the membership of the group. The acting Chairman summarised the previous discussions and it was agreed that Dr Timothy Morris should be invited to contribute expertise in the area of pharmaceutical research. With regard to expertise in the promotion of alternatives to research involving animals, it was agreed that Professor Robert Combes should be invited.
MINUTES
3 The minutes of the last meeting were approved.
EVIDENCE REVIEWS
Comparison of international regulations
4 It was observed that the Animal Procedure Committee APC might already have literature comparing international regulations. The Home Office (HO) should be approached to ascertain this. Alternatively it might be possible to obtain suggestions for suitable individuals who might be able to undertake the review.
The capacity of animals to suffer
5 It had been proposed that two separate reviews for the capacity of animals to experience harm should be produced. One of these should focus on philosophical issues, the other on issues arising in animal husbandry. The guidelines for authors were agreed and two nominations were made for possible authors.
Alternatives
6 The definition of the term ‘alternative’ was discussed and it was observed that the term covered two separate concepts. One was the idea of using a technique which did not involve animals to replace an existing procedure that did involve animals. The other was the idea of using an altogether different approach or research strategy, which avoided the use of animals, to reach an experimental goal or to understand more about a particular area.
7 It was agreed that both these concepts should be considered in the evidence review. The guidelines for authors would be revised to incorporate these points. It was proposed that the author of the evidence review should be agreed after the new member of the Working Party was appointed.
Perspective of the pharmaceutical industry
8 It was noted that the pharmaceutical industry used animals for research in two different ways. First, there was use for research and development of medicines, which included the use of genomics and knock-out technologies. Secondly, there was toxicology testing. It was proposed that two papers would be necessary to cover these distinct areas. The guidelines for authors should be amended accordingly. It was agreed that a decision about the author of the review should be delayed until a new member of the Working Party had been appointed.
FUTURE FACT FINDING MEETINGS
9 The fact finding meeting with representatives from patient organisations such as the Parkinson’s Disease Society, Muscular Dystrophy Campaign or the Multiple Sclerosis Society, should be brought forward to September.
10 An additional fact finding meeting would take place in late September or early October with a CRO and an academic laboratory. Members were invited to make suggestions for other fact finding meetings to the Secretariat.
CONSULTATION WITH THE PUBLIC
11 It was agreed that three strands of the consultation exercise should be taken forward: a written consultation, an on-line consultation, and a consultation with young people. The written and on-line consultation would be launched in September. Funding would need to be sought for the consultation with young people, to be held in collaboration with ECSITE and the science centre, @ Bristol.
12 The draft consultation document was discussed in detail and several revisions were agreed. The consultation document would be revised in light of specific comments by members and re-circulated to the Working Party.
Date of the next meeting: 16 September 2003
Section B - Fact finding meeting held at Pfizer, Sandwich, on 2 July 2003,
PRESENT
Baroness Perry of Southwark (Chair)
Professor Barry Keverne FRS
Professor Martin Raff FRS
Mr Nick Ross
Professor Jonathan Wolff
SECRETARIAT
Dr Sandy Thomas, Harald Schmidt
STAFF OF PFIZER
Dr Gill Samuels, CBE Senior Director, Science Policy and Scientific Affairs
Graham Moore, Consultant, Science Policy and Scientific Affairs
Further key personnel (Certificate Holder, Named Veterinary Surgeon, Named Animal Care and Welfare Officer, Project Licence Holder – Veterinary Medicines, Personal Licensee – Human Medicinals, Home Office Liaison Officer, Director of Animal Welfare
MINUTES
1 A brief introduction to the drug discovery process was followed by a visit to the animal facilities. It was not possible to visit the dog facilities, due to construction work. However, members of the Working Party were invited to visit these facilities at a later stage. More than 99% of research undertaken on animals at Pfizer was classified as mild or moderate under the UK’s classification system for severity of procedures.
2 Members of the Working Party undertook a tour of the laboratories and had the opportunity to see the housing of the animals and their use in procedures. The use of telemetry in rodents was explained, and members were introduced to research on drugs for neuropathic pain, which involved albino rats. Members also saw research involving terminally anesthetised albino rabbits which were kept for therapeutic research into female sexual dysfunction. The continuation of the tour took members of the Working Party through the non-animal research area. Automated Laboratory In Vitro Assay Systems (ALIAS) were used to screen compounds for the identification of candidate drugs.
3 Staff involved in the ethical review of research then gave an overview of the regulatory framework and described the details of the review process and interaction with the Home Office. This was followed by a general discussion session, which addressed issues arising in the context of transferring results from different kinds of animals to humans; differences between the effect of regulations on academic and industrial researchers, and ways of engaging with the public on research involving animals.
Last Updated Mon, 7 June 2004