Conference Proceedings, 21 May 2002
Proceedings of the Conference held in
the House of Lords, 21st May 2002
Chaired by the Chairman of the Select Committee,
Lord Smith of Clifton.
Lord Smith welcomed the delegates and thanked them
He said that the conference was intended to provide
the best possible information for the Committee. It was unlikely
that consensus would be reached within the working groups, but
it would nonetheless be useful for the Committee to be able to
take a helicopter view of all shades of opinion before they began
to draft their final report.
Five speakers were invited to give short presentations.
Dr James Anderson, Home Office Inspectorate
Dr Anderson said that the Animals (Scientific Procedures)
Act 1986 was "enabling legislation" which was the UK
implementation of Directive EC 86/609. The core of the Act was
a principle the cost/benefit analysis. This meant that
the Act was perpetually applicable and constantly contemporary.
Over the 15 years of the operation of the Act there
had been advances in animal facilities and accommodation and,
principally, the establishment of a "culture of care".
An important feature of the Act is that all the key questions
on scientific validity and alternatives were matters of judgement
concerning the available information. Confidence in the Act came
down to both scientists and anti-vivisection organisations having
confidence in the Inspectorate.
Dr Anderson said that compulsory training modules
had been introduced for personal licence holders (1994), project
licence applicants (1995) and Named Veterinary Surgeons (1996).
Training for NACWOs was in prospect. He also discussed the Ethical
Review Process. This had had a beneficial effect on the consideration
of animal welfare, although it also had the potential to become
bureaucratic. The Inspectorate's review gave examples of best
practice to help ERPs operate more efficiently.
Dr Pete Clifton, British Psychological Society
Dr Clifton said that the 1986 Act was a great improvement
over the previous legislation: accommodation standards had improved
and more veterinarians and animal welfare experts were involved.
He considered that the Act struck an excellent balance.
The cost/benefit analysis was hampered by the need
for more research into animal behaviour to assess animal welfare
better, and the fact that the benefits of "blue skies"
research were intrinsically unpredictable. Replacement alternatives
were often not possible, so emphasis should be placed on reduction
Bureaucracy in obtaining licences meant that some
experiments were simply not done in the UK. There had also been
difficulties with permissions for visiting scientists. Finally,
he said that the inclusion in the Statistics of GM animals used
solely for breeding was misleading.
Dr Maggy Jennings, RSPCA
Dr Jennings said that the RSPCA had a goal to end
all animal experiments, but worked in the short term to minimise
animal suffering. Animals lives also had intrinsic worth and should
not be wasted. The RSPCA had four specific concerns.
One, alternatives and toxicology. A fundamental change
was required: instead of justifying animal use, thought needed
to be given to how the need for animals could be removed. In vivo
and in vitro testing should be integrated, rather than attempting
to replace each individual animal test with a non-animal alternative.
This shift in attitude required changes in tertiary science education.
Two, freedom of information. There was no information
on how costs and benefits were determined by the Inspectorate,
and the Statistics gave no account of animal suffering. Confidentiality
hampered the development of alternatives and limited input into
the regulatory process. It also prevented effective communication
between Government bodies such as the APC, UKXIRA and the Home
Three, regulation. The life experience of experimental
animals should be taken into account as "cost". The
"acquisition of knowledge" was too broad a category
for benefit, as it could justify almost anything.
Four, the ERP was the key to improving local implementation
of the Act. There should be increased lay and animal welfare membership.
Dr David Smith, AstraZeneca
Dr Smith said that animal testing removed severely
toxic compounds, identified likely adverse effects, and established
the safe starting dose and dose response: "The right dose
differentiates a poison from a remedy" (Paracelsus). Risk
assessment was not absolute safety. Acceptable levels of risk
were determined by society, which is increasing its demand for
reassurance. Identifying low-incidence effects required many more
He said that the easy gains in replacement alternatives
had already been made. There had been limited progress with the
use of whole organs. In particular the liver, where human toxicity
was most frequently found, was not well understood. Emphasis should
be placed on improving the "failure rate" of compounds
at the molecular level before they were ever tested on animals.
Regulatory "box-ticking" should be removed: he cited
a joint industry/animal welfare initiative to dissuade the EU
from any possible increase in group size. The numbers of animals
used were not, however, as important as the welfare of the animals
that were used. A holistic approach to the Three Rs was advocated.
Toxicologists had problems with: the supply of animals
(the closing of breeding farms in the UK simply meant that more
animals were transported from abroad); intimidation by Animal
Rights groups in the UK, which affected the ability to recruit
and retain staff and over-optimistic assessments of alternative
technologies. Toxicologists were making efforts to engage with
animal rights groups, but disliked change for change sake if clear
animal welfare benefits were not forthcoming.
Michelle Thew, BUAV
Michelle Thew said that she shared Dr Smith's conviction
that there was a need for new medicines and a need for them to
be as safe as possible. However, researchers would not experiment
on humans without obtaining their consent, whatever the need.
She considered, similarly, that the deliberate infliction of suffering
on another animal, if not for its benefit, was immoral.
It was generally accepted that animals did indeed
suffer, but over 60% of procedures were carried out without anaesthesia.
The Act should operate with clear and transparent policy guidelines
and reflect informed public opinion currently it was operated
by ex-animal researchers for animal researchers. She quoted Dr
Mark Matfield from the Research Defence Society to the effect
that security concerns were often over-stated. These concerns
were nonetheless used to prevent transparency and accountability.
Duplicate testing was a problem, as the Home Office
only encourages, but does not require, the sharing of data. Improvements
such as the banning of research on Great Apes, or for cosmetics,
were a start, but why was research not also banned on all primates,
or for household products? Transparency was central for a proper
debate. The BUAV could only advocate for animals if it had access
to adequate information.
Report of Working Group 1: Centre(s) for Alternatives
Chair/Rapporteur: Dr Kenneth Boyd
1. It was generally agreed that targeted resources
would help to promote and develop alternatives, though more in
fundamental research than in toxicology.
2. Many of the best 'alternatives' had been developed
by animal scientists in the course of their work, as they had
the necessary expertise in a particular scientific field. Scientists
must be encouraged to continue the development of alternatives.
3. This was not sufficient by itself, however, particularly
as scientists tended to concentrate on reduction and refinement
rather than on replacement. The MRC's Centre for Best Practice,
for example, was focused on welfare rather than replacement.
4. There was already an enormous amount of information
available, but it was on many different databases and there was
little quality control. An overview of alternatives was also
needed as even when individual replacement tests were developed,
they often did not fit into the regulatory toxicology system.
5. Alternatives needed to be developed in context.
Ring-fenced funding in other areas had not improved the quality
of work done. Free-standing centres for alternatives would not
be able to draw on the immensely wide range of necessary expertise.
The onus would also then be taken off animal scientists to consider
6. There was very little enthusiasm for a free-standing
'wet lab', an independent monolithic research facility, or another
7. What was needed was a centre for strategic planning
to co-ordinate funding, give alternatives science academic status,
provide reliable high quality information, and encourage scientists
themselves to develop alternatives.
Possible Structure of an Alternatives Centre
8. There was a remarkable degree of consensus in
the group of the type of alternatives centre that would be most
constructive. A hub and spokes model was proposed.
9. There should be a virtual centre at the hub.
This would be a portal to relevant databases for alternatives
(possibly including its own database), and provide a forum for
sharing information (possibly including databases of 'negative
results'). It could co-ordinate existing 'alternatives' funding
by charities, industry and the Home Office.
10. The centre should be independent and funded by
a wide range of interested parties, not just by industry. It should
have close links to the Home Office and their internal databases.
The Home Office could require project licence applicants to consult
the centre as proof of their search for alternatives.
11. In addition, the centre should co-ordinate 'spokes'.
These would consist of small research groups with different specialisations
incorporated into existing research centres at Universities and
medical schools. These small units would draw on the existing
expertise in research centres, and act as drivers to incorporate
alternatives research into the every day business of research
12. Some people were unhappy with the word 'alternatives'.
It was suggested that the national hub should be called the 'Centre
for the 3Rs'.
Other possible actions
13. Improving an awareness of and need for alternatives
could also be achieved in other ways. One, three Rs terms should
be added as search keywords to existing databases.
14. Two, Funding bodies should require applicants
to demonstrate their search for alternatives and state what innovative
techniques relating to the 3Rs their projects involve. Journals
should require articles based on animal experimentation to incorporate
a short note on the use or development of the 3Rs. These two
steps would keep the issue of the 3Rs at the forefront of scientists
15. Three, there was a need for better training in
statistics and experimental design.
16. In plenary, it was commented that "the world
is full of partly developed databases". The difficulties
in maintaining even the virtual centre should not be underestimated.
The centre would require a commitment to long-term funding.
17. Such a centre should act as a "champion"
for alternatives, even if it did not conduct any actual research
Report of Working Group 2: Toxicology
Chair/Rapporteur: Dr Barry Phillips (RSPCA)
How effective and reliable are in vivo toxicity
1. In toxicology, in vivo toxicity tests (those using
live animals) form only part of a complex process of risk assessment
that takes account of other sources of information, including
analysis of chemical structure and in vitro tests, and is also
subject to expert interpretation and judgement. The purpose of
toxicological risk assessment is to evaluate the likelihood of
harmful effects on health from exposure to specific doses (or
concentrations) of particular chemicals, and thus to inform the
risk management process (actions such as prohibition of the use
of a chemical, the specification of maximum recommended doses,
or the provision of advice on safety precautions).
2. The effectiveness of in vivo toxicity tests per
se is difficult to assess and cannot simply be deduced from the
effectiveness of the entire risk assessment process. Thus, although
there was agreement that human health and safety are, in the main,
well protected by the current process, there was some disagreement
as to whether this was due to the use of animal tests, or in spite
of their use.
3. There is little hard scientific evidence upon
which to base a judgement of the reliability of in vivo toxicity
tests. This is due to the ethical constraints on testing chemicals
in human subjects which preclude the confirmation in humans of
adverse findings in animals. Only in the case of pharmaceutical
substances, administered in doses judged to be safe, or after
accidental exposure to chemicals, can the results of animal tests
be checked against actual human experience.
4. Recently, the International Life Sciences Institute
(ILSI) undertook a study of a series of pharmaceutical compounds
that had shown toxicity in human clinical trials.
This study found that in 71% of cases, the effects seen in people
were foreshadowed in the animal tests carried out prior to the
clinical trials. When the results of tests on rodents were considered
in isolation, only 43% of the human toxicities could have been
predicted. Tests on dogs or primates were necessary to increase
the prediction of toxicity to 71%. Of the 29% of effects not detected
in animal tests, the majority were of a type that the animal tests
were not designed to detect, or were intrinsically undetectable
in this type of test e.g. headache and dizziness, and certain
5. It was agreed that the ILSI study has limitations,
and that the general reliability of animal tests is very difficult
to judge, as some animal tests may be more reliable than others.
In broad terms, those tests designed to detect severe or rapidly
developing effects, such as acute oral toxicity or irritancy,
appear to be more predictive of human health effects than those
attempting to detect more subtle, long-term effects. Deficiencies
in the design of certain tests may also compromise their reliability.
For example, the use of very high doses of chemicals in rodent
cancer bioassays has given rise to a high incidence of findings
that are unlikely to be of significance to human health.
6. It was noted that rare effects, in a small sub-group
of the human population, are very difficult, if not impossible,
to predict using laboratory tests or even in clinical trials.
7. It was pointed out that the validation requirements
for non-animal tests is in marked contrast to the almost total
lack of formal validation of animal test methods. Despite uncertainty
about the reliability of animal tests, alternative methods are
expected to give the same results. A figure of greater than 80%
concordance with animal test results was quoted as a requirement
for validation of an alternative method in the USA. A better method
might actually be rejected because it gave correct results (correct
prediction of human health effects) more often than the existing
8. It was concluded that the effectiveness and reliability
of animal tests is unproven. It was recommended that the reliability
and relevance of all existing animal tests should be reviewed
as a matter of urgency.
9. It was suggested that the long-term solution to
the problem was to work for a better understanding of the basis
of disease and toxic effects, so that tests based on knowledge
of the fundamental mechanisms involved could be designed rationally.
What is the scientific justification for (a) the
use of a second, non-rodent species in chronic toxicity testing,
and (b) the seemingly formulaic use of certain species (such as
10. The justification generally given for the use
of a second, non-rodent, species is that rodent studies do not
detect all toxic effects because of species differences. However,
the scientific basis for the use of two species is questionable;
tests could be conducted in any number of species and the relevance
of the findings for man would be equally uncertain for all the
species used. The use of two species is a compromise which provides
some reassurance that important toxic effects have not been missed.
11. On a case-by-case basis, an appropriate test
species can be chosen rationally if existing knowledge about specific
chemicals indicates that one species is more likely than another
to respond to a chemical in a similar way to man. In some cases,
studies of human tissue in vitro can guide species choice. A number
of organisations have published guidelines on the choice of appropriate
test species. However, for practical reasons, the choice of species
is very limited; a major consideration is experience in using
a particular species, and the existence of a body of historical
data on that species.
12. A study of the role of dog studies in pharmaceutical
found that for 115 pharmaceuticals,
dog studies confirmed the findings from rat studies in 63% of
cases but provided additional information in 37% of cases. New
findings in the dog resulted in termination of drug development
in 11% of all studies. Although the relevance of the findings
for human safety could not be ascertained, the study recorded
a 'consensus among toxicologists that the dog plays an essential
role in the safety evaluation of pharmaceuticals'.
13. The formulaic use of two species in safety testing
was not considered to be a scientifically justifiable practice,
but rather an acknowledgement of the problem of species differences
in extrapolating the results of animal tests to predict effects
14. The routine use of the dog in addition to the
rat is a compromise which is largely dictated by practical considerations.
Nevertheless, studies in dogs have provided important information.
Are new compounds ever tested on humans when they
have already showed an adverse reaction in animals? If so, what
is the purpose of the animal experiments?
15. All chemicals have some degree of toxicity. In
the case of pharmaceuticals, compounds are intended to have beneficial
effects on the human body; their pharmacological activity. If
this activity is excessive, it becomes detrimental. The purpose
of animal tests is to define the dosage which will yield a beneficial
rather than a detrimental effect. Inevitably, the animal tests
will be designed to include doses which have adverse effects.
16. In addition to the pharmacological effects of
medicinal chemicals, they and all other chemicals have adverse
side effects at certain doses. The purpose of animal tests is
to define the nature of these effects and the likelihood of their
occurrence at particular doses.
17. The process of risk assessment, based on animal
test data, followed by risk management measures, is intended to
ensure that human exposure is restricted to levels that do not
result in an unacceptable risk of adverse effects. It is to be
expected that chemicals will be used for various purposes despite
the fact that adverse toxicological effects have been found in
18. One specific example was discussedthe
fact that many licensed medicines have been shown to induce cancer
in rodents. It was acknowledged that rodent cancer tests can give
very misleading results, due to factors such as hormonal disturbance,
chronic irritation, and stimulation of rodent-specific receptor
molecules. It is also widely accepted that studies are poorly
designed, using unrealistically high doses of chemicals. For this
reason, the results are often considered irrelevant to human risk
assessment. Nevertheless, the tests are useful for identifying
potent carcinogens. Another factor mentioned was the clinical
risk/benefit calculation, where a clinician must decide whether
the risks of adverse effects from a particular treatment outweigh
the risks of withholding treatment. The use of medicines with
known adverse effects in animals may or may not be justifiable,
but the information on risk is essential.
19. The number of people who suffer from 'Adverse
Drug Reactions' is often cited as evidence that animal tests fail
to protect people from toxic medicines. The point was made that
the majority of such cases were due to poor practice and overdosing.
Others argued that the figures often cited for Adverse Drug Reactions
had already taken such factors into account.
The risks associated with potent medicines
may be well defined, but inappropriate use cannot always be prevented.
20. It was concluded that all chemicals have toxic
effects at high enough doses. The purpose of the animal experiments
is to estimate the potency of the chemical so that margins of
safety can be established.
Can there be absolute and objective measures of
21. It was considered that toxicity is a deviation
from normal which is not absolute, short of death, but that many
forms of toxicity can be measured objectively.
What is a realistic timeframe for the reduction
of animal use in toxicology by (a) 20%, (b) 50% and (c) 90%? Can
the complete elimination of animal use in toxicology ever be envisaged?
22. There was general agreement that a 20% reduction
could be achieved very quickly by means of harmonisation of test
guidelines, reductions in the number of animals used in each test,
and greater use of available alternative methods. A 50% reduction
would require considerably more development and scientific research
but was feasible within 10 years. A 90% reduction would probably
take at least 20 years, and would need a major breakthrough in
modelling of biokinetics (mathematical methods for predicting
uptake, metabolism and excretion of chemicals in the body) and/or
a rapid development of toxicogenomics (molecular biological techniques).
23. Funding of research on alternatives was considered
to be poor. At the EU level, research funded by DG Research has
not led to the development of any new tests. In the UK, there
is some support provided by the APC and potentially by the MRC,
but there appears to be a lack of high quality applications for
work in this field. A new approach was considered essential to
identify promising areas of research, raise the status of alternatives-related
research, and provide funds on a large scale.
24. For chemicals testing, a forum for discussion
is needed, analogous to the International Conference on Harmonisation
(ICH) for pharmaceuticals.
25. Some members of the group believed that complete
replacement of animals in toxicology was possible as long as there
was sufficient will and determination. A minority view was that
all animal testing could be replaced immediately, although it
was acknowledged that this was not the accepted view of most scientists
and regulators, and that changing these attitudes was probably
a long-term objective.
Which research areas are most likely to lead to
the replacement of animals in toxicology (e.g. computer modelling,
in vitro human tissue testing, or in vitro animal tissue testing)?
26. The group agreed that the three examples quoted
are important areas but that progress could also be made by making
greater use of human volunteer studies and that the development
of computer based biokinetic/pharmacokinetic modelling was fundamental
to the successful application of in vitro tests.
27. The use of human tissue suffers from problems
of supply which need to be addressed urgently. The use of 'humanised'
cells (mammalian cells containing inserted human genes) could
also be helpful.
28. New molecular techniques such as toxicogenomics
and metabonomics were considered unlikely to be useful in replacing
animal tests but could be effective in reducing animal use or
in developing refined test designs.
29. Ultimately, an increased understanding of the
mechanisms of toxicity, e.g. sensitisation, irritancy and carcinogenicity,
will lead to the rational design of in vitro tests.
Does the search for alternatives focus too much
on replacement? Is sufficient attention given to reduction and
30. Considerable advances have been made in reduction
and refinement, for example in the acceptance of alternatives
to the oral LD50 test. Harmonisation of guidelines is also a very
effective reduction strategy.
31. The development of new alternative methods as
replacements usually requires more financial support because it
involves a great deal of laboratory work, and extensive inter-laboratory
validation studies. In comparison, the development of reduction
and refinement alternatives is generally less costly and their
introduction less contentious; extensive validation is usually
not required. Education and training is a particularly important
and cost-effective strategy for promoting the use of alternatives,
good study design and improved animal welfare.
32. The group considered that the three Rs are inter-linked
and should all the subject of research.
What are the obstacles to promoting alternatives
33. The demand in the USA for testing chemicals for
endocrine disrupting properties was cited as an example of testing
driven by legal requirements rather than sound science. This and
several other examples, such as testing for effects in juvenile
animals and for behavioural endpoints, were considered to relate
to a general problem of regulators in the USA exercising a high
level of individual power.
34. In Europe, the current legislation on chemicals
requires the submission of the results of prescribed sets of tests;
the 'checklist' approach. Unnecessary or irrelevant testing may
be done simply to complete a required data set. It is hoped that
the proposed new EU chemicals strategy will be based on a sensible,
structured approach to testing.
35. The group considered that some animal testing
was done for 'administrative', rather than scientific reasons.
More flexibility and intelligence is needed in chemical testing.
36. The main obstacle to the validation of alternative
methods is the poor quality of the data from the corresponding
animal test with which the new method is compared. Even when sound
data exist, obtaining test results from chemical companies is
often a problem. A way forward must be found to enable validation
to proceed without the need for animal test results.
37. Acceptance of alternative methods by the OECD
is crucial to their widespread use in toxicology. This has proved
to be an extremely slow process.
Report of Working Group 3: Freedom of Information
Chair/Rapporteur: Dr Jon Turney (UCL)
Section 24 of the 1986 Act
1. Section 24 of the Act does not, in theory, work
as a blanket ban on the distribution of any information held by
the Home Office relating to animal experiments. The Home Office
does not accept that all information is confidential and it considers
all requests for information. Animal welfare groups asserted that,
in practice, the Home Office has cited section 24 as a reason
for withholding information.
2. Section 24 should be repealed because, in practice,
little information is considered by the Home Office to be non-confidential
and little is therefore released to the public on request. Repealing
section 24 would help to change the culture of secrecy at the
Home Office in line with the principles of openness outlined in
the Freedom of Information Act 2000.
3. By itself, however, repealing section 24 would
not be sufficient to enable the public to access information.
Under the Freedom of Information Act, section 38 (relating to
putting individuals at risk) and section 41 (relating to confidential
information) could still be used to prevent the release of information
about animal experiments into the public domain.
4. Some felt that duplication was a real problem.
Others argued that it was an essential part of the scientific
process. As in other areas, more transparency could prevent unnecessary
duplication and reassure the public when duplication was necessary.
Involvement of Animal Welfare Groups in Cost/Benefit
5. Cost/benefit assessment is a moral and subjective
judgement and should reflect public opinion rather than the opinions
of a narrow group of scientists, as at present.
6. Animal welfare groups do not wish to be involved
in licensing because it would conflict with their remit, involving
them in the regulation of animal experiments. Ethical committees
do not have the resources to do a rigorous scientific review of
the need for each animal experiment.
7. Welfare groups could be involved prior to licensing,
on some sort of board for assessing the need for animal experiments,
to which scientists could be brought to make suggestions for alternative
8. Animal welfare groups need to feel as though they
could have an impact. For this to happen, and to allow for meaningful
dialogue, there needs to be greater transparency and public access
Information for the general public
9. Relevant government publications are currently
difficult to access. More data need to be placed in the public
arena, using the world wide web.
Role of Scientists
10. Scientists could help to increase understanding
by avoiding the use of euphemistic language when referring to
animal experiments, and by providing frank descriptions of what
was done to the animals.
11. Failed experiments, not just those that were
successful, should be written up and published.
12. Scientists do write up experiments that disprove
hypotheses, because this is as scientifically important as experiments
that proved hypotheses.
13. Scientists need to communicate about their experiments
in a precise manner so that others can repeat the experiments.
Lay summaries could be included in addition to the usual article
written for other scientists.
14. Scientists should criticise other scientists
in the glare of the media, not just in scientific journals.
15. The media present the issues in a polarised manner
and has treated all positions unfairly.
16. Very few science graduates have participated
in experiments on animals throughout school and a decreasing number
during university education.
17. Issues about animals should be taught in schools
on a philosophical basis in order to encourage children to think
through the issues carefully. The debate should not refer just
to animal experiments but how society uses animals in general,
for example in food production.
18. The published Statistics are not intended to
enable public understanding, but are for statisticians. They
are particularly unhelpful as they show only aggregated figures;
however, even disaggregated figures would not be much better.
19. Suffering can not easily be recorded in a meaningful
way. It might help to increase the number of severity categories
and give some general descriptions about the type of suffering,
in addition to cross-references to the Statistics.
20. Actual levels of suffering could be retrospectively
reported, and related to broad categories of procedures or common
Training for scientists and laboratory workers
21. Scientists and laboratory-workers, particularly
senior personnel, should be re-trained every few years.
22. The focus should not be on re-training but on
continuing professional development.
Points made in Plenary Session
23. There is a need for more collaborative discussion
24. The media is not one entity: some journalists
and broadcasters are becoming more nuanced and responsible in
their reporting of the issues.
Report of Working Group 4: Regulation and the
Ethical Review Process
Chair/Rapporteur: Dr Jane Smith (Boyd Group)
Should the role of the Inspectorate be reviewed?
1. There was agreement that 21 inspectors had not
been sufficient. Some members felt that the new target number
of 33 would be sufficient; others that numbers are not the crucial
issue. Whether numbers are sufficient depends on what precisely
the role of the Inspectorate is to be.
2. It was noted that currently over half of all inspections
are unannounced, reducing the validity of accusations of 'cosiness',
and more such unannounced inspections would be welcomed by all.
3. There was disagreement about the extent to which
the present inspection system is balanced. Certain participants
argued that inspectors are not sufficiently disinterested, because
nearly all have previously been licensed to work experimentally
on animals. They therefore come from within the system rather
than sitting outside of it. For this reason, some maintained
that there should be inspectors charged solely with animal care
and welfare, who had never held licences, and could act as the
animals' advocates. Others argued that this role was already
provided for by the NVS/NACWO team.
4. It was agreed that there is currently a lack of
transparency in the workings of the Inspectorate. For example,
the proportion of project licence applications that are turned
down both (i) initially; and (ii) even after final resubmission,
is neither published nor known to welfare and other campaigning
organisations. Moreover, it is unclear how severity limits and
bands are defined and how the cost benefit assessment is applied
in practice. There was consensus that more openness is needed.
5. It was noted that separating the roles of the
Inspectorate into (i) inspecting; and (ii) providing expert advice
would increase the demands on the Inspectorate as the 'inspecting'
Inspector would not already have the detailed, contextualised
knowledge of the project licence. With more inspectors, a greater
degree of team working and specialisation within the Inspectorate
would be feasible. It was agreed that there was a need for more
independent enquiry in cases of criticism of the Inspectorate
or alleged wrong-doings under the Act.
How could the Ethical Review Process be improved?
6. It was agreed that ERPs should have true external
members. There was debate about whether these should be strictly
'lay'; who should be classified as a lay person; and who would
command the confidence of the wider community. It was agreed that
there was a need for feedback on the contribution that lay members
have made, and could make, within the ERP.
7. Members disagreed as to whether an anti-vivisectionist
could be a member of an ERP and whether anti-vivisectionists counted
as 'lay people'. Some anti-vivisectionist participants indicated
that they would, in any case, not wish to be involved in an ERP.
8. It was suggested that, in order to represent the
interests of animals, there was a need, not only for 'lay' people,
but also for independent external experts in animal welfare.
9. It was observed that it was difficult for lay
people to challenge the claim that knowledge per se is a benefit.
Those in favour of animal experimentation could always argue that
there might be instrumental (e.g. medical) benefits from almost
any scientific procedure at some point in the future.
10. Some participants felt that ERPs duplicate the
work of the Inspectorate; others that ERPs and the Inspectorate
complement one another. At present ERPs technically only advise
certificate holders and the role of ERPs would therefore change
if they were to have the power to approve minor amendments. Although
there was some support for moving to a system in which ERPs could
approve very minor or welfare-friendly amendments to project licences,
there was also some reluctance on the part of participants who
were members of ERPs to move too far into a judgmental, rather
than an advisory role.
Are levels of bureaucracy having an adverse impact
on (a) animal welfare, and (b) scientific research in the UK?
11. It was observed that it is difficult to comment
on the impact of bureaucracy because every case is different.
It could take considerable time to gain approval for a PPL, but
it was agreed that this is often for good reasons and is not always
the 'fault' of the ERP and/or Inspectorate. Project licences
last for five years, and it can take time to get such wide ranging
documents right. There was disagreement as to the extent to which
such delays really hold back UK science.
12. There was more agreement, however, that the process
of approval for applications for minor amendments to projects
can be unnecessarily cumbersome. If an ERP approval process were
to be available for minor and welfare-friendly amendments, there
would be a need to define 'minor'. It was noted that this question
already occurs in the context of fast tracking minor amendments
by ERPs. Although many ERPs have their own guidelines on what
counts as "minor", it would be impossible to draw up
a definitive list, even within a single establishment. A case-by-case
approach would be more appropriate and trust in the NVS and NAWCO
13. There was disagreement about the extent to which
members of the Inspectorate are consistent with regard to the
detail that they require on project licences. One person maintained
that such differences are not great and that the Inspectorate
goes to great lengths to minimise them; another person maintained
that some Inspectors actively help project licence applicants
to write their applications so as to allow for their flexible
interpretation whilst other inspectors require great specificity.
221 Olson, H. et al., "Concordance of the toxicity
of pharmaceuticals in humans and in animals", Regulatory
Toxicology and Pharmacology, vol. 32 (2000), 56-67. Back
Broadhead, C. L. et al., "Prospects for reducing and
refining the use of dogs in regulatory toxicity testing of pharmaceuticals",
Human and Experimental Toxicology, vol. 19 (2000), 440-47. Back
See, for example, Lazarou, J., Pomeranz, B.H., Corey, P.N. Incidence
of Adverse Drug Reactions in hospitalised patients: a meta-analysis
of prospective studies. Journal of the American Medical Association,
Volume 279 (15), 1200-05 (1998). Back