Mike O'Brien MP
Parliamentary Under Secretary of State
Home Office
50 Queen Anne's Gate

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:

  1. The close relationship of the Inspectorate with animal researchers in the licensing process and other aspects of the enforcement of animal research regulations.
  2. 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.
  3. 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...].

  • [Removed...].
  • The illegal re-use of animals at HLS [removed...].
  • The incarceration of wild-caught baboons [removed...].
  • [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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