The Ombudsman's Report on Home Office Regulation of Imutran Xenotransplantation Research: the Need for a Public Administration Select Committee Inquiry


On 15 December 2006, the Parliamentary and Health Service Ombudsman (PHSO) laid before Parliament a report (PA-2823) that dismissed Uncaged's complaint of maladministration in respect of the Home Office's regulation of Imutran's pig-to-primate xenotransplantation research (1994-2000). (1)

As we explain below, we believe that the PHSO's investigation and report are fundamentally flawed. We submit that the PHSO's investigation has been opaque, ambiguous and partial, and their report fails to reach coherent, evidence-based judgements. Of particular concern are the several instances where primates were found dead or in a collapsed state in procedures assessed as of merely 'moderate' severity. Thus, in exonerating the Home Office, the PHSO's has failed to hold the department to account for its failure to properly assess and minimise the suffering of animals.

Animal experimentation raises major ethical and social concerns, and is a matter of significant public interest. It is vital that the public has genuine confidence in the impartiality of regulators and the rule of law. We are therefore seeking an investigation into the PHSO report by the Public Administration Select Committee.

The author of this briefing, Dr Dan Lyons has recently been awarded a PhD for his research into the evolution of animal research policy, thereby establishing him as one of Britain's leading academic authorities on this area of public policy.


In spring 2000, confidential documents relating to pig-to-primate organ transplants were leaked from the company responsible, Imutran. Our analysis of the data led us to believe that not only had Imutran breached the Animals (Scientific Procedures) Act 1986, but the Home Office had failed to implement key regulations. Following Uncaged's attempted publication of this information in September 2000, Imutran and their parent company Novartis sought a permanent injunction for breach of confidentiality and copyright.

The Home Office initially announced that such allegations would be investigated with the assistance of a small independent scrutiny team from the expert advisory body, the Animal Procedures Committee. However, the Home Office reneged on this commitment and instead launched an internal 'routine' review. Essentially, the very persons criticised by Uncaged investigated their own conduct.

In 2002, further documents - including crucial project licences and correspondence between Imutran and the Home Office - were leaked from the Home Office. Interestingly, the Home Office declined the opportunity to intervene in the case to prevent disclosure of its confidential documents.

In 2003 the Defendants secured a historic legal victory that allowed publication of over a thousand pages of confidential documents which revealed matters of public interest, in particular the Home Office's indulgent relationship with Imutran. Despite this outcome, the Home Office has persisted with its refusal to establish an independent inquiry into the affair. Lacking the financial resources to initiate judicial review proceedings, Uncaged sought redress through the Home Affairs Committee (HAC) and the PHSO. The HAC decided not to conduct a full inquiry for various logistical reasons, such as their existing workload.

Severity assessment and control

Many aspects of the PHSO report can be refuted. However, we believe that the clearest and most salient aspect of Home Office maladministration - and PHSO error - concerns the failure to adequately assess and control primate pain and suffering caused by the procedures. This is perhaps the most important aspect of the regulatory system and therefore any such failures are particularly significant for adequate public administration.

Uncaged explained to the PHSO that during the initial project licence application for kidney xenotransplantation experiments (which covered the majority of Imutran's xenotransplantation research), Imutran and the Home Office deliberately underplayed their severity in order to smooth through the approval of the application.

The experiments were classified as of 'moderate' severity rather than the higher 'substantial' category: this meant that the proposed experiments avoided examination by the statutory Animal Procedures Committee (APC), which would have potentially delayed or blocked the application at a time when Imutran were determined to push ahead with the research as quickly as possible.

According to stated regulations, animal experiments are assessed as 'moderate' when not a single animal is in danger of suffering a 'major departure from their usual state of health or well-being' or 'significant post-operative suffering': such adverse effects are supposed to be categorised as 'substantial' severity. One clear distinction between 'moderate' and 'substantial' severity is that in 'substantial' experiments, the experiments might continue until the animal dies.

Even before the kidney xenotransplantation experiments commenced, Imutran and the Home Office must have known that the experiments would have the potential to cause 'substantial' suffering due to:

  • The highly invasive abdominal vivisection
  • complications likely to arise from unconventional transplant surgery on relatively small animals
  • the toxic effects of very high doses of experimental immunosuppressive drug regimens
  • the effects of kidney rejection over a number of days, causing nausea, vomiting, coma and death

Primates 'found dead'

In the event, in 'moderate' experiments at least seventeen primates, such as Monkey X535f (see box right), were found dead in their cages, and many more were allowed to deteriorate to a collapsed state before they were finally euthanased.

The RSPCA report into this affair describes the adverse effects endured by the primates - such as whole body shaking, grinding of teeth, haemorrhaging, vomiting, weakness, wound-weeping, gangrene, tremors and diarrhoea - as 'severe,... serious and very unpleasant'. They go on to criticise the moderate severity rating, arguing that a substantial rating was 'without doubt' necessary: 'to alert the scientists and technicians involved to the need for greater vigilance, and in order to ensure a meaningful, realistic and honest cost-benefit analysis'.

Thus, two issues of maladministration arise:

  1. the initial severity assessment was incorrect - partly because Imutran and the Home Office failed to take proper account of the adverse effects of drug poisoning in the licence application
  2. the subsequent breaches of the moderate severity limit

The PHSO report (see particularly paragraphs 13-14) has rejected this complaint on the basis of a fundamental misinterpretation of the case and the regulations. In particular, the PHSO states that death, in itself, is not considered to necessarily be a harm to the animals and thus is not necessarily a breach of the moderate severity limit. However, the PHSO's position is derived from regulatory discussions concerning experiments performed under terminal anaesthesia, where the animal is not conscious during any part of the experiments and is killed before it comes round. This is a fundamentally different situation to the Imutran experiments where animals were allowed to suffer for several days until they died. We clearly could not be saying that 'death in itself' was the issue here given that we are pointing out that the animals should have been euthanased earlier in the procedure.

We've consulted other experts in this policy area - former members of the APC - who have stated that the PHSO's position is 'totally surreal' and that we are 'absolutely correct and they are completely wrong'.

We pointed out the PHSO's crucial mistake to them in our request for a review of the complaint decision. However, the PHSO refused to consider or respond to this point, eventually asserting that it was merely an amplification of our original complaint and 'did not raise new issues'. The PHSO's position is unsound: our argument on this point was new as it responded specifically to the key justification put forward in the PHSO report. We have been left with the impression that the PHSO's priority has been to dispose of the case and defend their original decision rather than operate an open and fair review process.

1. Please note that this is a different case to the xenotransplantation-related research currently licensed by the Home Office that Uncaged is lobbying on.

Dr Dan Lyons, Uncaged Campaigns, January 2007


Credit: Organ Farm

"Sandoz [Imutran's funders and collaborators] have suggested kidney transplants, the Home Office will attempt to get these classified as moderate procedures".
Minute of meeting at Imutran.











Baboon operation
Credit: Organ Farm

"We therefore urgently request authority to use five of the forty-four baboons, without further reference to the APC..."
Letter from Imutran to Home Office











Baboon operation
Credit: Organ Farm


Day 5, am: "Subdued, heavy lidded, sitting on perch, slight body tremors. Weak, and very severely bruised. No faeces seen."

Day 5, pm: "Subdued, heavy lidded, sitting on perch, slight body tremors. Weak, slightly unsteady when moving. Very severely bruised. No faeces seen."

Day 6, am: Found dead on cage floor.



















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