EDM 74 'Ombudsman and Suffering in Animal Experiments'

EDM 74 highlights the fundamental flaws in the Ombudsman's report into illegal cruelty to primates in organ transplant experiments. Leaked records revealed debilitating and lethal experiments, in clear breach of regulations. EDM 74 calls upon the Government to establish an independent inquiry into the affair. The text for this Early Day Motion is as follows:

"That this House notes the Parliamentary and Health Service Ombudsman's (PHSO) investigation report PA-2823 that rejects Uncaged's complaint against the Home Office's regulation of Imutran's pig-to-primate organ transplant research, laid before Parliament in December 2006; further notes that Uncaged won a legal battle having asserted Home Office maladministration in this case; further notes that at least 17 primates that were used in Imutran procedures categorised as of only moderate severity were found dead or in a collapsed state, rather than being euthanased before they suffered a significant departure from their health as required by the moderate severity limit according to published policy; is deeply concerned about the PHSO's erroneous reasoning at paragraph 13, which confuses the degree of harm caused by death in itself with the level of harm involved in this case where the experiments were allowed to continue until the animal is found dead as a direct result of the experiment; notes that the PHSO has repeatedly refused to respond substantively to Uncaged's expert submissions regarding this unsound reasoning; and asks the Government to establish an independent inquiry into the numerous significant outstanding concerns regarding the regulation of this research programme in the light of PHSO's flawed investigation."

Public Interest

In 2003, Uncaged achieved a historic 'David-and-Goliath' legal victory over pig organ transplant research company Imutran and their parent company Novartis Pharma. Having initially sought complete suppression of the documents when the case began in 2000, Imutran/Novartis eventually caved in and settled out of court after the Defendants had been awarded legal aid.

This allowed the publication of thousands of pages of leaked research documents, on the grounds that there was a public interest in the disclosure of Home Office misconduct. Uncaged subsequently lodged a complaint with the Parliamentary and Health Service Ombudsman in respect of the Home Office's failure to apply laws and regulations to Imutran's animal experiments.

The main concern focussed on the regulatory breaches in the way that animal suffering was assessed and controlled. 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 animals die.

Flagrant Breaches

The main adverse effects caused by the Imutran experiments involved acute drug toxicity, infections and organ failure. Many monkeys and baboons were allowed to suffer for so long that they were literally 'found dead' or 'in a collapsed state'. Uncaged point out that these were flagrant breaches of the moderate severity limit, and they prove that the original assessment was mistaken. Moreover, the Home Office has turned a blind eye to these breaches of the moderate severity. A leaked minute of a Imutran meeting reveals just one example of the collusion between the Government and the animal research industry: "Sandoz [Imutran's funders and collaborators at the time] have suggested kidney transplants, the Home Office will attempt to get these classified as moderate procedures". The Home Office probably bent the rules because they wanted to help Imutran to get permission for these experiments more quickly and easily than if the correct 'substantial' or 'severe' severity assessment had been made.

The RSPCA have also called for an independent inquiry. Their 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'. The 'cost-benefit assessment' - as it is officially known - of animal experimentation projects is supposed to be the cornerstone of the UK regulatory system, determining whether experiments are permitted and, if so, how much suffering is authorised. When the regulations refer to 'costs', what they really mean is the degree of harm suffered by animals.

Ombudsman's Elementary Misunderstanding

The Ombudsman's report (ref: PA-2823), was finally laid before Parliament on 15 December 2006. The key finding was the exoneration of the Home Office's categorisation of lethal pig-to-primate organ transplant experiments as of merely 'moderate' severity. However, the Ombudsman has let the Home Office off the hook on the basis of an elementary misunderstanding of the facts of the case and the requirements of the regulatory system. The Ombudsman states that death, in itself, does not count legally as a 'harm' to the animals and thus does not necessarily indicate a breach of the moderate severity limit. However, the Ombudsman's position is derived from regulatory discussions about experiments performed under terminal anaesthesia, where the animal is not conscious during any part of the experiments and is killed before it comes round. Clearly, this is completely irrelevant to this case.

On the contrary, in many of the Imutran experiments, death was the 'endpoint'. In other words, some of the experiments with their severe adverse effects continued while the animals were conscious for several days until they died. The whole point of an effective 'moderate' severity limit is that the experiment must be stopped - normally by euthanasia - before an animal becomes significantly unwell or dies as a result of the adverse effects caused by the procedure. So 'death in itself' is completely irrelevant to Uncaged's complaint. Consequently, the Ombudsman's decision is totally unsound.

Furthermore, and contrary to their letter to MPs, the Ombudsman has refused to consider these submissions by Uncaged, despite the fact that they raise unique, novel substantive issues.

Legal Developments Confirm Home Office Maladministration

The recent judgement in the Judicial Review brought by the BUAV against the Home Office in a parallel case confirms beyond any reasonable doubt that the Ombudsman was incorrect in failing to uphold Uncaged's complaint against the Home Office in respect of its implementation of severity assessments and limits.

On 27 July 2007, Justice Mitting ruled that the Government has been unlawfully downplaying the suffering of animals when granting licences for animal experimentation. Importantly, his decision was based not just on the application of the law in the cases of the individual procedures the BUAV investigated at Cambridge, but on the Home Office's operation of the 1986 Act more generally. Therefore, this ruling clarifies the context for the Home Office's regulation of the Imutran xenotransplantation procedures.

Justice Mitting concluded that the decision to allocate certain protocols in the Cambridge case a 'moderate' rather than 'substantial' severity limit was "vitiated by legal error and was clearly wrong" (section 43) for the following reasons which are applicable to the Imutran case.

The Home Office was judged to be in error because they "did not accept that adverse effects severe enough to require the animals to be killed, rather than treated by means short of killing… were capable of amounting to major departures from health or well-being" (43).

In practice, the Imutran xenotransplantation research programme procedures involved experiments that continued until the primates were found dead. Therefore, they exceeded the benchmark for 'substantial' severity set by Justice Mitting, and thus unequivocally correspond to a 'substantial' rather than 'moderate' severity limit according to the definitions in the Guidance on the Operation of the Animals (Scientific Procedures) Act 1986 as laid before Parliament.

Furthermore, the project licence protocols under which the Imutran experiments were performed anticipated adverse effects severe enough to require the animals to be killed. Indeed, all the animals who were not found dead were 'sacrificed' due to the severe and irreversible adverse effects they suffered (adverse effects which in many cases clearly exceeded the definition of a moderate severity limit).

In addition, at paragraphs 36 and 40 of his judgement, Justice Mitting ruled that the Home Office's general policy of applying a relative rather than objective standard when allocating 'moderate' or 'substantial' severity limits was unlawful. Therefore, this further indicates that the Home Office has failed to apply the correct test when assessing the severity of the Imutran xenotransplantation procedures. Therefore Justice Mitting's conclusion of legal error is applicable to the Home Office's conduct in the Imutran case.

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