Select Committee on Animals In Scientific Procedures Report


CHAPTER 5: REGULATION AND THE ANIMALS (SCIENTIFIC PROCEDURES) ACT 1986

5.1  Among those who work under the Act, there is a general acceptance that the basic legislation works well. Disagreement with the operation of the Act is focused on practical matters arising out of the Act, rather than with the Act itself.

5.2  Witnesses who are opposed to vivisection clearly object to the premises of the Act. Section 24 — the statutory bar on the disclosure of information by the Home Office — was frequently criticised by both animal rights and animal welfare groups, who argue that informed debate without the disclosure of appropriate information is impossible.

5.3  Many witnesses who were concerned with animal welfare rather than with animal rights were perhaps surprisingly uncritical of the Act. With the exception of Section 24, their complaints were that many aspects of the Act were not being adequately enforced. Many were particularly critical of the lack of adequate inspection, and by what they considered was the less than rigorous enforcement of the requirement that no animal procedure should be performed where there is a non-animal replacement, and that refinements and reductions should be incorporated wherever possible.

5.4  What follows is a consideration of some of the detailed aspects of the operation of the 1986 Act, and how we consider beneficial changes could be made.

  

THE INSPECTORATE

5.5  The Inspectorate is composed of registered medical and veterinary practitioners, who usually have experience of biomedical research and possess appropriate postgraduate qualifications.[124] Inspectors are both highly skilled and specifically trained in laboratory animal science. Although scientists often complain about the licensing system, many are highly complimentary about the Inspectors themselves. Currently there are 25 Inspectors. The Home Office hopes to increase the number of Inspectors to 33 by the beginning of 2004, but we note that recruitment has been particularly slow in the past year, and even this timetable seems optimistic.[125]

5.6  Some have argued that as Inspectors have all been involved in animal experimentation at some point, they cannot be trusted to operate the Act impartially.[126] Inspectors have also been accused by some animal welfare groups of becoming too closely involved with licence holders, so that they do not inspect premises sufficiently rigorously. Others reply that the Named Veterinary Surgeon (NVS) and Named Animal Care and Welfare Officer (NACWO) ensure that the animals' interests are represented, and that the Inspectors are extremely rigorous in their inspections.

5.7  Belief in the impartiality of the Inspectorate has been undermined by allegations such as those made by Uncaged Campaigns concerning Imutran, a company which undertook research into xenotransplantation.[127] The Home Office, despite promising in November 2000 that members of the APC would participate in any investigations into allegations of malpractice, did not invite the APC to participate in the investigation into Imutran. Indeed, no formal investigation took place, only a routine review of compliance issues by the Inspectorate.[128] The actions of the Inspectorate, which were criticised by Uncaged, were also not subject to scrutiny by an external body.

5.8  The name "Inspectorate" suggests to the general public that inspection of animals is a large part of its role, and the Inspectorate do indeed carry out around 2,100 visits to licensed, designated establishments each year. Some witnesses have argued that the Inspectorate should spend even more time in its role as the "police force" of the 1986 Act.[129] The Chief Inspector, however, disagreed:

"the greatest contribution the Inspectorate makes to laboratory animal welfare is at the design and planning stage. I hesitate to say that we should be taking resources away from that at present to put back into inspection" (Q. 129).

5.9  We agree that good advice on project design and the incorporation of the Three Rs has a far more beneficial effect on animal welfare than the maintenance of minimum standards through increased inspection. In their dual role of advisor and inspector, the Inspectorate have created a culture of care which is far more effective than the threat of a few more unannounced visits.[130]

5.10  We have therefore considered, but rejected, the proposal that the Inspectorate should be divided into those who advise on the Project Licences and those who actually inspect the premises. The detailed knowledge of the projects in progress enables the Inspectorate to continue to advise on procedures to the benefit of both science and animal welfare. We therefore agree with the assessment of the Home Office Minister, Angela Eagle MP, that "there is a synergy between the licensing process and the inspection process" (Q. 519).

5.11  We conclude, however, that the Inspectorate are an inappropriate body to monitor the effectiveness of new Home Office regulations. This was demonstrated by the review by the Inspectorate of the implementation of the Ethical Review Process (ERP).[131] We consider this review to be flawed on many counts: the Inspectorate paid only cursory attention to the resource implications of implementing the ERP; shortcomings are blamed on local implementation while the Home Office and Inspectorate exonerate themselves entirely; and interviews were conducted by Inspectors, thus discouraging licence holders from voicing any criticisms of the implementation of the process by the Inspectorate. Any such future reviews of the effects of changes in policy should be conducted by a more independent group such as the Animal Procedures Committee.

5.12  Both these matters, the independence of the inspection process and the independence of policy review, centre on the monitoring of the Inspectorate — Sed quis custodiet ipsos custodes?[132] The independence of the Inspectorate is important if the public is to have confidence in the regulatory system; it is also important that researchers consider that they receive consistent, impartial advice.

5.13  We recommend that the Inspectorate should be subject to periodic review, by a body other than the Inspectorate itself.

5.14  We wish to avoid being over-prescriptive on how such a review might be carried out. We suggest that such a review might be instigated by the APC. We note also that the reviewing body would need to have access to all the Inspectorate's records, including notes of what was seen and done during inspections of designated establishments.[133] We consider that this level of information should be made available to ensure that the Inspectorate is sufficiently accountable.

5.15  We consider that the Inspectorate is a trustworthy, professional body. They certainly had the confidence of the Minister, Angela Eagle MP, who considered that "the Inspectorate do a very, very good job to a high degree of integrity. They do not let the friendly relationships they may have with individuals that work in labs have an effect on the work they are producing" (Q. 538). However, we also recognise that it is important to remove any suggestion of complicity between the local Inspector and the Licence holders.

5.16  Furthermore, the practice whereby one Inspector does the bulk of the advice and inspection in one establishment has led to examples of inconsistency. Lord Winston said, "We have had licences turned down by one Inspector in the United Kingdom where elsewhere the same licence has been given in the north of England" (Q. 1842). Inspections already occasionally involve Inspectors with particular expertise from other areas (Qs 1928-30). We consider that this good practice should be extended and formally instituted.

5.17  We recommend that designated establishments should be inspected once a year by an Inspector from another area.

5.18  We are also interested in the idea put forward by Professor Page, that "lay visitors" should accompany inspectors on their visits (Q. 946).[134] We invite the Home Office to consider how "lay visitors", possibly NACWOs or lay members from ERPs, might be encouraged and enabled to obtain access to other research establishments, to ensure consistency of inspection and to spread best practice in animal care.

  

WEIGHING OF HARMS AND BENEFITS

5.19  The weighing of harms and benefits, often called the "cost/benefit analysis", lies at the heart of the 1986 Act. Before licensing any procedure, the Act requires the Secretary of State to take account of "the likely adverse effects on the animals concerned against the benefit likely to accrue".[135] A note on the "cost/benefit" assessment by the Chief Inspector in 1993 states that "almost none of the elements in the cost/benefit analysis lend themselves to strict quantification. What is required is a balanced, rational judgement of justification based upon the information gathered."[136]

5.20  It has been suggested that the term "cost/benefit" is misleading, as "cost" refers to the harm done to the animals involved rather than to any financial cost. Parallels with cost/benefit analyses in financial contexts also suggest that the assessment is quantifiable, whereas in practice it is really a question of professional judgement. It has therefore been suggested that it should be renamed "harm/benefit".

5.21  The assessment of harms and benefits is what gives the Act its flexibility, but also means that confidence in the Act in predicated on confidence in whoever carries out the assessment — usually the Inspectorate on behalf of the Secretary of State. Under the current system, Dr Hubrecht from UFAW considered that the projected benefits were sometimes exaggerated, while the projected harms to the animals over their entire life were not always taken into account (Q. 619). This view was supported by Dr Maggie Jennings from the RSPCA (Q. 612).[137] It is therefore important that the assessment is carried out in as transparent a manner as possible. It is important too that researchers do not rely on the Inspectorate, the ERP, the NVS or the NACWO to take animal suffering into account. Researchers must accept personal responsibility for the life-long welfare of their animals.

5.22  The APC is currently in the process of producing a report on the cost/benefit assessment, but we understand that this will not be available until the autumn of 2002.

5.23  Currently there is too little information on how decisions on cost/benefit are reached. It has been suggested that project licences should be made publicly available before they are approved, so that interested groups can suggest replacements, reductions and refinements, or point to similar research which has already taken place.[138] We consider that such a practice would only delay further the already lengthy licensing process. We do, however, consider that the public should be able to discover the principles on which the weighing of harms and benefits is done.

5.24  We recommend that the substantive details of anonymised project licences, which describe the expected benefits of the research and harms to the animals involved, should be made public after they have been approved and funded.

5.25  The Government have indicated that there are certain procedures which use animals which the Secretary of State will not permit. One of these is the use of animals for surgical training. At present, all applications to practise microsurgery on anaesthetised animals that are not allowed to recover have to go to the APC. All other applications to practise surgery are not permitted under the Act.

5.26  This seems to us to be misguided. We would far rather that surgeons carried out their first operations on terminally anaesthetised animals rather than on us, and assume that most patients share this view. The benefits likely to accrue from the acquisition of certain technical skills seem to be of far more immediate applicability to human and animal welfare than many of the justifications under which the use of animals is licensed. Surgeons often go to Canada or other countries to practise surgery on animals.[139] Such training should be licensed in the UK.

5.27  We recommend that the current restrictions on the use of terminally anaesthetised animals for training surgeons should be relaxed.

  

LICENCE APPLICATIONS AND BUREAUCRACY

5.28  It is worth emphasising that the 1986 Act requires personal, institutional, and project licences. The UK is the only country to require an explicit cost/benefit assessment of every application to conduct animal research. All protocols are examined by the local Ethical Review Process and the Inspectorate; research proposals are also subject to peer review by funding bodies. All establishments are subject to frequent and stringent inspection.

5.29  Most scientists who conduct research on animals are content with these requirements. They take pride in the fact that the UK has rigorous ethical standards, and are aware that good animal welfare leads to good science. There has, however, been a substantial amount of criticism, not of the Act itself, but of the way in which it has been implemented and the associated delays.

5.30  In particular, complaints about the levels of bureaucracy relate to the time taken to process project licences and amendments to licences. The Expert Group on Efficient Regulation, chaired by Professor Iain Purchase, produced a report in October 2001 which compared the time taken to comply with comparable regulations in the UK, Germany, France and the United States.[140] Professor Purchase also submitted to this Committee a summary of the report which indicated that the total time taken to prepare a submission for approval and receive approval was 31 weeks in the UK, 17 weeks in Germany, and 6 weeks in the US.[141]

5.31  The effect of this bureaucratic burden in the UK is disputed. Many scientists argue that bureaucratic restrictions lead to research being hindered, abandoned or carried out abroad. This was supported by anecdotal evidence.[142] Other witnesses countered that there was very little concrete evidence to support this view, and that other factors, such as the availability of good scientists, had far more effect on the siting of research.[143] The reality is hard to discover: bureaucratic delays do not force industry to move research out the UK, but they are a factor which affects decisions on where to site new research. As Dr Kipling from the ABPI said, "the key issue is the lost opportunities" (Q. 985). We do not wish the science base in the UK to be adversely affected by unnecessary bureaucracy.

5.32  Numerous witnesses acknowledged that the UK has the most tightly regulated system of animal procedures in the world. This is often said with pride, as if tight regulation intrinsically led to improved animal welfare. We do not agree. Bureaucracy in itself does not contribute to animal welfare. In fact, we have heard anecdotal evidence that bureaucracy can actively harm animal welfare. Witnesses from the Royal Society said that unnecessary standardisation of animals' environments could lead to poor welfare, and that bureaucracy had led to experiments being carried out on three animals instead of on one.[144] Professor Blakemore gave the example that a minor amendment to use a new and superior anaesthetic took over three months for approval (Q. 972). Dr Matfield from the Research Defence Society said that amendments to licences had taken so long to be approved that research had become outdated and was therefore abandoned half way through — with the consequent unnecessary use of animals (Q. 928).

5.33  We consider that the UK should strive not for the tightest regulation, but for the best regulation, properly enforced.

5.34  Following discussions of the Pharmaceutical Industry Competitiveness Task Force in 2001, the Home Office agreed with industry a licensing time of 35 "clock days".[145] The Home Office say that the great majority of licence applications are now processed within this time. This is a step in the right direction, and we commend the Home Office for improving their standards to this level. The DTI say that the Government are making progress towards solving the problem of bureaucracy, but they also admit that there are a number of issues still to be reviewed, including the simplification of project licences.[146]

5.35  The Home Office has been slow, for example, to develop a system to allow licences to be filled out and processed electronically. In evidence, officials from the Home Office indicated that they are now addressing this problem, although they would not say when such electronic processing would be possible (Q. 1896). This is not encouraging given past experience of the implementation of new computer systems.

5.36  We also consider that project licences are unnecessarily complicated. We have been permitted to see 5 project licences. The two shortest of these were between 40 and 50 pages long; the longest licence consisted of just over 300 pages. We understand that the Home Office is beginning a consultation with industry to see how these licences could be simplified, and we strongly support this. It is also clear that scientists themselves are partly to blame. The Royal Society said that applications from universities tend to be less well put together than those from industry (Q. 1042).

5.37  We still consider that, overall, the Home Office has not given enough consideration to the effects of bureaucracy on the science base in the UK. The amount of evidence we have received on the subject of bureaucracy is considerable, but is dismissed by the Home Office as anecdotal (Qs 1879-81). The Chief Inspector did not address the question of how minor amendments to project licences could be processed more quickly, but said that such amendments should not be necessary (Q. 1882).

5.38  The current attitude of the Inspectorate and the Home Office is insufficiently self-critical — they insist that the documentation works well, and that all delays and difficulties are the fault of those who fill in the application forms. The Inspectorate made what we consider to be an unhelpful distinction between "information" and "detail" on project licences. If, as the Chief Inspector said, too much superfluous detail is given, then licence applicants should be advised accordingly (Qs 1880-82).

5.39  We would like to see the Inspectorate taking responsibility for simplifying the licences, and clarifying exactly what is and what is not required. We consider that they could take a greater role in spreading best practice in licence applications.[147] We note that, in France, the average length of the equivalent licence is 10 pages, which for many projects we consider to be a reasonable length.

5.40  We recommend that urgent consideration should be given by the Home Office to the simplification of project licences, with the aim of reducing the length of a typical licence to 10 pages.

5.41  In addition, we consider that the system of approval of amendments to project licences needs to be streamlined. Some amendments are substantial, and should be subject to the same rigorous approval process as the initial licence application. Other amendments, however, are minor or routine, and in many cases either have no effect on animal welfare or have a beneficial effect on animal welfare. We discuss how the system of approval of such minor and routine amendments could be improved in the next chapter.

  

TRAINING MODULES

5.42  All holders of personal licences under the Act are required to attend training modules.[148] Although one or two witnesses complained about these modules, they were not a matter of particular concern except in two areas: visiting scientists and students in higher education.[149]

5.43  Visiting scientists, however experienced or well qualified, are required to complete training Module 1 — this lays out the historical background to the Act, gives an introduction to ethical aspects of the use of animals in scientific procedures, and explains the way in which the Act operates. Professor Blakemore said this was "a training and examination procedure that is designed for novices" (Q. 977) and that it was "a hindrance to Britain's participation in the international business of research" (Q. 956); similarly, Professor Bateson of the Royal Society said "We are very worried about the slowness of that procedure…If we cannot get visitors to come here that is really going to affect UK research." (Q. 1036)

5.44  The Chief Inspector was aware of the problem, but did not consider that the Home Office should be responsible for its solution.[150] As with a number of other issues, we consider that the Home Office would rather distance itself from problems than be proactive in finding and providing solutions.

5.45  We were told that a similar problem applied to students taking one year intercalated courses. By the time that they had received their licences there was scarcely time for them to do any research.[151] In France, by contrast, students work under the tutelage of a Professor, who remains responsible for their actions and for animal welfare. We consider that this system should be extended.

5.46  We recommend that visiting scientists and students in higher education should be allowed to carry out work under the licences of an established licence-holder, who would take responsibility for their actions and for the maintenance of animal welfare.

5.47  We recommend that scientists of whatever grade should have a personal responsibility for the welfare of the animals in their care.

  

THE ANIMAL PROCEDURES COMMITTEE

5.48  The Reverend Professor Michael Banner, the Chairman of the APC, summed up its role as:

"an independent and expert body…charged under the Act with giving advice to the Secretary of State on his duties in relation to experimental animals. We can have issues referred to us by the Home Secretary, though that has been infrequent. Otherwise we undertake… as a rolling programme, a review of the various important elements of the Act and its operation" (Q. 3).[152]

5.49  The APC is charged with keeping the Act under review. Professor Banner said that it has a "wide representation of nearly all viewpoints" (Q. 2). Members are unpaid, and the work of the APC is limited both by the availability of its members and by the limited resources of its secretariat. We have also heard that the APC cannot always obtain all the papers it needs to carry out its scrutiny role effectively.[153] The APC disburses £280,000 per annum for research into the Three Rs.

5.50  The APC has a very general function in considering controversial licence applications and in keeping the Act under review, but it has no executive authority and no clear lines of accountability. It is a committee looking for a role. We consider that it should take a more active part in monitoring the work of the Inspectorate;[154] and that it should continue to hold high level meetings to discuss questions of the validity of animal and non-animal tests. We hope, also, that the APC might help to keep matters raised in this report before Government.

5.51  In this report we make a number of recommendations where we envisage that the APC will take a greater role. It is likely to need more resources, and consideration should also be given as to whether members of the APC should be paid.[155]

5.52  We recommend that the secretariat of the Animal Procedures Committee should be strengthened and more clearly separated from the Home Office regulators.



124   See the memorandum by the Home Office (printed with the oral evidence of 3 July 2001). Back

125   Qs 1871-74. Back

126   BUAV (Q. 445). Back

127   For further details, see the report by the RSPCA, "Non-Human Primates in Xenotransplantation Research in the UK" (June 2002). Back

128   Robert McCracken, a member of the APC, was unhappy with this review: "the concerns raised … were not allayed by the brief, routine report by the Inspectorate" (Q. 804).  Back

129   NAVS (Q. 1323). Back

130   As Les Ward, Director of Advocates for Animals commented, the "law is based on trust. It does not matter how many inspectors you have." (Q. 1368) Back

131   Published in November 2001. Back

132   Juvenal, Satires VI, l. 347. In this context translated as, "But who will inspect the inspectors themselves?". Back

133   Robert McCracken said that much of this information was currently unavailable even to the APC (Q. 849). Back

134   Robert McCracken put forward a similar idea for "Boards of Visitors", similar to those for prisons, in paragraph 9 of his memorandum (printed with his oral evidence). Back

135   Section 5(4). Back

136   A Note on the Cost/Benefit Assessment is printed in the APC Annual Report for 1997, pp. 50-59. Back

137   This is also one of the principal conclusions of the RSPCA report, "Non-Human Primates in Xenotransplantation Research in the UK" (June 2002), of which Dr Jennings is the principal author. Back

138   BUAV (Q. 449). This is also discussed in the APC's Report on Openness (2001), paras 32-33. Back

139   This was said in the programme, "Frontline: Animal Research", presented by Professor John Martin, British Heart Foundation Professor of Cardiovascular Medicine, University College, London (who also submitted written evidence). The film was originally broadcast on Channel 4 on 6 & 7 September 1995 and again on 17 March 1997. The MOD confirmed that surgeons did indeed go abroad to practise surgery on animals (Q. 1594). Back

140   The Regulation of the Use of Animals in Scientific Procedures, the Expert Group on Efficient Regulation (October, 2001). Back

141   French scientists considered that the question of approval was simply not relevant. Back

142   For example, Professor Clive Page from King's College London spoke of emphysema research being carried out in the US rather than in the UK (Qs 871-73), and said that he had sent research students abroad on four recent occasions (Q. 874); Lord Winston spoke of carrying out research in the US due to a "scientific misunderstanding" by the Home Office (Q. 1835); see also memoranda by the Laboratory Animals Science Association and Professor John Martin. Back

143   For example, the Royal Society (Q. 1035) and the DTI (paragraph 40 of the memorandum printed with their oral evidence). Back

144   Professor Patrick Bateson and Dr Michael Festing (Q. 1039). Back

145   "Clock days" are working days when the project licence is actually with the Inspectorate. If the licence needs to be returned to the applicant, days when the licence is with the applicant or in the post are not included. Back

146   Paragraphs 22-23 of the memorandum printed with the DTI's oral evidence. Back

147   There are welcome signs that this is beginning to happen - see note by Professor Rothwell (p. 184). Back

148   See Appendix F of the Home Office Guidance on the Operation of the Animals (Scientific Procedures) Act 1986. Back

149   Professor Blakemore (Q. 956); and the Royal Society (Q. 1036). Back

150   Q. 1988 and Q. 1992. Back

151   Royal Society (Q. 1037 and Q. 1041). Back

152   See also para. 1.3(vii). Back

153   Robert McCracken, paragraph 7.1 of the memorandum printed with his oral evidence. Back

154   See paras 5.13-5.14. Back

155   Currently, the Chairman of the APC receives an honorarium, but other members receive only expenses. Back


 
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