OPEN LETTER TO THE HOME OFFICE
Mike O'Brien MP
Parliamentary Under Secretary of State
Home Office
50 Queen Anne's Gate
London
SW1H 9AT
7 November 2000
Dear Mr O'Brien
Thank you for setting aside time to meet with us last Thursday
to discuss the Home Office's response to the Diaries of Despair
report and the accompanying documents describing Imutran's pig-to-primate
xenotransplantation experiments at Huntingdon Life Sciences. However,
we would like to register our disappointment regarding the fact
that you had not read the report in advance of the meeting.
Having considered our discussions at the meeting, these are our
thoughts.
The need for independence
Before listing some of the specific instances arising from the
Imutran documentation that give rise to the requirement for a judicial
inquiry, I would like first to reiterate the overarching reasons
why Uncaged has called for a judicial inquiry. Generally speaking,
we believe that there is strong evidence that regulation of animal
experiments is not working in the way the public desires and which
Parliament intended when it enacted the Animals (Scientific Procedures)
Act 1986. To be more specific, the Inspectorate is not protecting
animals properly and is not ensuring that the law is correctly applied
(for example, with regard to the issue of severe suffering). This
is demonstrated not just by the documents relating to Imutran's
xenotransplantation work sent to Uncaged but also by successive
undercover investigations, not least the BUAV's into Harlan. The
problems are systemic and appear to be cultural. This is why the
inquiry needs to do more than establish the facts relating to this
particular project licence; it also needs to establish what lessons
should be learnt and applied to the licensing of animal experiments
more generally.
You said that one of your key objectives was to ensure that there
is public confidence in the system of regulation. We agree that
public confidence is very important. Unfortunately, we do not believe
that it exists at present. Certainly, neither the animal protection
movement nor - for very different reasons - the animal research
community believes that the system is working properly. From the
animal protection perspective, that derives in part from the fact
that virtually all the inspectors are ex-licence holders.
Whatever form the investigation takes, the overriding consideration
is that it must be seen to be independent. By this we mean independent
of those who have been criticised, including the Inspectorate. This
rules it out of any lead role in the investigation. We believe that
the Inspectorate has been shown to be seriously at fault in relation
to Imutran's xenotransplantation research.
The specific reasons for an independent judicial inquiry
The report and documents reveal the concerns about regulatory failures
which give rise to the necessity for an independent judicial inquiry:
they fall into three general categories:
- The close relationship of the Inspectorate with animal researchers
in the licensing process and other aspects of the enforcement
of animal research regulations.
- Concerns about the manner in which the cost-benefit assessment
and severity limits are executed by the Inspectorate, which fail
to take due consideration either of the level of suffering of
the animals subjected to xenotransplantation research or of factors
which undermine the likelihood of any benefits accruing.
- Other conduct by the Home Office in relation to this programme
of research, such as the legitimacy of the decision to re-issue
HLS with a Certificate of Designation in autumn 1997.
Before we list the issues, it is important to bear in mind the
overall significance of the matter in hand. This significance arises
from the fact that what we are discussing is the licensing of deadly
procedures on hundreds of non-human primates which evidently caused
those animals extreme and severe suffering. Apart from the intrinsic
significance and controversy of the deliberate infliction on pain
on sentient creatures, these experiments were undoubtedly some of
the most extreme to be licensed by the Home Office in the last six
years, involving as they did hundreds of higher primates (some wild-caught)
and severely painful and distressing procedures.
1. The Inspectorate's close relationship with Imutran
Concerns are raised in this area by the following documents/incidents:
[This section of the letter has been edited in order to
remove the confidential information that Imutran is trying to prevent
from being placed in the public domain.]
- The manipulative attitude towards the Home Office by Imutran
[removed...]
- The minutes of an Imutran meeting [removed...]
Following the deaths of three cynomolgus monkeys in August 1998
due to crates [removed...]
[This section of the letter has been edited in order to
remove the confidential information that Imutran is trying to prevent
from being placed in the public domain.]
2. Assessment of severity and cost/benefit considerations
[Removed...] strongly suggest that the primates
experienced severe suffering. Current guidance claims that the Secretary
of State will not licence such procedures. The guidance in operation
at the time includes a de facto ban on severe suffering in the conditions
attached to personal licences (#14). Article 8 of the European Directive
86/609 stipulates: "If anaesthesia is not possible, analgesics
or other appropriate methods should be used in order to ensure as
far as possible that pain, suffering, distress or harm are limited
and that in any event the animal is not subject to severe
pain, distress or suffering."
The issue here is not only whether the animals experienced severe
pain and distress, but also that such severity was predictable given
the nature of the procedures, and therefore the research should
never have been licensed.
Apart from the intrinsic severity of the procedures, a great deal
of evidence relating to the factors relevant to the cost-benefit
assessment has come to light in the report and documentation. Many
of these undermine the legitimacy of the research programme on cost/benefit
grounds (see pages 151-154 of report). Examples [removed...],
the high technical failure rates, doubts over the likely utility
of xenotransplantation ([removed...]), [removed...],
failures in the performance of the experiments such as failures
to take crucial [removed...] readings, overdosing,
[removed...], hundreds of readings not taken in
error. Not only does it appear that the Inspectorate failed to conduct
an adequate cost/benefit assessment at the outset of the project,
but it failed to take account of how the project developed in its
ongoing judgment of the costs and benefits of the programme.
3. Other regulatory issues
Several other incidents have been brought to light through the
publication of the acquired documents:
The deaths of three primates en route from the Philippines to the
xenotransplantation research laboratories at Huntingdon Life Sciences
(HLS). [Removed...]. Apart from the important ethical
issue of the suffering of the animals in the course of this journey,
which lasted [removed...] hours, the crates also
[removed...].
- The illegal re-use of animals at HLS [removed...].
- The incarceration of wild-caught baboons [removed...].
Present proposals for the investigation
You stated in your Written Answer on 1 November that you had "concluded
that the appointment of a small independent scrutiny team, drawn
from the Animal Procedures Committee… would be the best and
most practicable means of providing assurance that any future Inspectorate
investigations have been carried out with the necessary objectivity
and thoroughness." You therefore accept that there may be a
question mark over the Inspectorate's objectivity and thoroughness.
Nevertheless, the present proposal for investigating the matters
arising from the internal Imutran documents contained in your Written
Answer of Wednesday 1 November misses the fundamental point. Mrs
Gordon's question asked about investigations into "allegations
against establishments and individuals licensed under the Animals
(Scientific Procedures) Act 1986." However, the implications
of the Imutran documents concern the Inspectorate and the Home Office,
and not simply licensed individuals and establishments. Thus the
proposal contained in your answer is not appropriate in this instance,
if it is ever appropriate.
Harlan showed graphically why the Inspectorate is not the appropriate
body to conduct an investigation when it is alleged, on reasonable
grounds, that it has failed in its regulatory performance. You will
recall that the APC was critical of the Inspectorate's report. It
is, indeed, self-evident that there can be no public confidence
in an investigation conducted by the very body which is under fire.
This is not altered by the fact that others - here, Imutran and
HLS - are also severely criticised.
The suggestion that the APC should be involved in scrutinising
Inspectorate reports is flawed for a number of reasons, and ultimately
fails to address the basic problem of a lack of independence.
First, the APC is itself biased in favour of animal research (a
feature which makes it criticism of the Inspectorate's Harlan report
all the more telling). Under section 19 of the Act, two-thirds of
its members must have a scientific qualification, and the Committee
has always contained a majority who support vivisection. Animal
protection representation is marginal, and has recently decreased
even further through the retirement of Les Ward.
Secondly, once the principle of independence is accepted, the obvious
course is to ensure that the primary investigative team is independent.
The ability of a scrutiny team to ensure that an investigation has
been carried out properly is necessarily limited. It will be very
difficult for it to second-guess whether the Inspectorate has investigated
thoroughly and impartiality, asked pertinent questions at the relevant
time, evaluated the evidence fairly and so forth. The scrutiny team
will receive only a summary of such evidence as the Inspectorate
chooses to obtain and report. Even if team members could, in theory,
ask to see evidence itself, they would not know what evidence was
available and could, in practice, only see a small proportion of
it.
In addition, theirs would be a paper only exercise - scrutineers
would be unlikely to see conditions for themselves. A scrutineer
reading the Harlan report might well have concluded that the Inspectorate
had done its job properly. It was only because the BUAV - which
held the primary evidence - was able to point out its failure to
deal with much of the evidence properly or at all that its shortcomings
became apparent.
The principal objection, however, is that the Inspectorate would
remain judge in its own cause. This cannot engender public confidence.
If the Home Office remains uncertain of the grounds for an independent
judicial inquiry, then we suggest that an investigative team must,
at the very least, be wholly independent of the Home Office, including
the Inspectorate. It could consist of a licence-holder in the relevant
discipline (but obviously not one connected in any way to Imutran
or HLS), a representative from an animal protection organisation
and an individual with neither a personal vested interest in animal
experimentation nor a particular moral commitment to the abolition
of vivisection - for example, a non-animal research academic, vet
or lawyer.
However, we can see no reasonable objection to an independent judicial
inquiry. In opposition, Labour acknowledged the need for a root
and branch examination of the adequacy of the present system of
regulation in its support for a Royal Commission. An independent
judicial inquiry into this affair could fulfil this role in a more
succinct and efficient manner - as an example, it is my understanding
that the Lawrence Inquiry consisted of 56 days of hearings.
We appreciate your stated commitment to ensuring that animal research
regulations are enforced fairly and properly. However, to achieve
such a situation will undoubtedly require the kind of independent
scrutiny we are calling for following the exposure of Imutran's
xenotransplantation research. Your government has done virtually
nothing to overhaul the system you inherited from the previous Conservative
Government. This is time and the opportunity to do that.
I hope that this letter is useful. It explains our position in
more detail than we had the opportunity to last Thursday. Both Michelle
Thew and Andrew Tyler have seen this letter in draft and endorse
the overriding need for a truly independent inquiry.
I look forward to hearing from as soon as possible.
Yours sincerely,
Dan Lyons
Uncaged Campaigns
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