“(d) that the well-being and state of health of such animals are monitored by a suitably qualified person in order to prevent pain or avoidable suffering, distress or lasting harm; and (e) that arrangements are made to ensure that any defect or suffering discovered is eliminated as quickly as possible.”
“identifies the likely adverse effects, the means by which they will be avoided, recognised and alleviated; and sets the severity limit for the individual protocols and the severity band of the project as a whole.”
“5.18 The Secretary of State must be satisfied that protocols incorporate best practice and will be applied competently. Project licence applicants are required to provide a full description of the measures proposed to prevent or minimise the extent, duration and incidence of the adverse effects. These may include the specification of humane endpoints and control measures (such as inspection schedules, the criteria used to assess the adverse effects, and the means to be used to minimise them). 5.19 Humane endpoints should be set to provide for a number of eventualities: the research objectives having been achieved; the realisation that they cannot be achieved; or when welfare problems are encountered which exceed the minimum necessary to achieve the objective.”
“5.47 The assessment of the overall severity of a project will reflect the cumulative effect of each procedure. This assessment is used by the Secretary of State to weigh the likely adverse effects on all the animals to be used against the benefits likely to accrue, as required by Section 5(4) of the Act. 5.48 The assessment of the severity band for the project as a whole reflects the number of animals used on each protocol and the actual suffering likely to be caused as a result. It is based on the overall level of cumulative suffering to be experienced by each animal, not just the single worst possible case. It takes into account the proportion of animals expected to reach the severity limit of the protocol and the duration of the exposure to that severity limit, the nature and intensity of the adverse effects, and the actions to be taken to relieve the suffering. 5.49 The assessments of severity (of individual protocols or the project as a whole) should be reviewed and revised as necessary during the lifetime of a project.”
“The Guidance is not the means by which experts communicate with each other to the exclusion of the public, nor even the means by which they communicate what they are doing to the public; it is the means by which the Secretary of State speaks on behalf of the public to his officials and experts, to applicants for licences and to licence holders, and effect must be given to it in that context.”
“Animals will be subjected to the stereotaxic intracerebral implantation of guide cannulae, through burr holes in the skull, affixed to the skull with screws and dental cement, under general anaesthesia.”
“Describe the possible adverse effects, their likely incidence and proposed methods of prevention or control, for example by schemes of inspection, analgesic regimes and the application of specified humane end points. See paragraphs 4.12 and 4.13 of the Guidance. Normal post-surgical recovery lasting a few days: Maintenance in incubator in sheltered environment (eg quiet room) where appropriate. Nursing care, hand-feeding intake, drug treatments and scoring on scale of wellbeing at least twice daily but as frequently as necessary while in sheltered environment Post-surgical analgesia if required: intramuscular buphrenorphine or oral paracetamol for 1-2 days. Prophylactic antibiotics. Persistent alteration of mood or movement such as to interfere with self-care – kill animal. Transient epilepsy – treat with anti-epileptic drugs. Persistent epilepsy – kill animal. Skin infection around cannulae (mild) – treat with antibodies on advice of Named Vet; (severe) – kill animal. The intention of this procedure is the alteration of cognitive function, which is monitored in behavioural testing. The drugs are not intended to have adverse effects on the animal’s well-being but may affect memory, or learning ability or may produce sedation. Where cognition is being assessed it is expected that the dose of drug used will be below that which produces overt behavioural effects. Where possible, known antidotes are kept available. These may be specific pharmacological antidotes (eg haloperidol to counteract amphetamine, antiepileptics to treat seizures) or symptomatic (eg neuroleptics to block hyperactivity or apparent psychosis, metaclopromide or ondansetron to treat vomiting, benzodiazepines to treat agitation). In the unlikely event of previously unencountered and uncontrollable effects the animal would be killed.”
“5.B.30 Animals in incubators were not monitored continuously. In practice, animals were monitored until it was confirmed that they were stable or improving; had recovered sufficiently from the general anaesthetic to protect their airways; and to establish the nature and extent of any immediate neurological dysfunction. If required the following were also provided: sufficient pain relief to be effective until the next scheduled observation and any other necessary specific, symptomatic or supportive treatments (e.g. fluid replacement, placement in an incubator to maintain body temperature, convalescence in a quiet dimly-lit environment and treatment with diazepam to prevent or control seizures). 5.B.31 This review has not identified any significant morbidity or any instance of mortality that would have been avoided by more intensive monitoring and care schedules. One case referenced in the BUAV report, an animal named ‘Agar’ that died between observations, was considered in particular detail. It is considered that all appropriate treatment had been given, and that all appropriate measures had been taken to minimise the suffering experienced by the animal.”
“For the purpose of testing the issue it is only necessary to refer to three of the seven protocols in any detail. All but one of them were categorised as moderate. Two involved general anaesthesia and a craniotomy, cutting through the skull and turning it on a hinge of bone to expose the meninges beneath, and resecting the meninges to expose the brain. In one protocol part of the brain was removed by suction ablation. In another, a cerebral artery was to be tied to produce a stroke intended to affect one limb. The anticipated effects of each included post-surgical recovery lasting a few days and transient epilepsy, each of which would be treated by drugs, and persistent alteration of mood or movement, such as to interfere with self-care, and persistent epilepsy, each of which would be dealt with by killing the animal. A third protocol stipulated that brain damage would be caused by “excitotoxic lesions” administered through a burr hole, in other words without a craniotomy. Similar post-operative effects were anticipated.”
“… should more severe adverse effects [than transient neurological defects or persisting defects which will not prevent animals undertaking their normal activities of daily living] be seen the problems will be promptly identified and remedied.”
“In addition, it should be noted that the action to be taken in some circumstances is to humanely kill the animal. Taking measures to alleviate adverse effects, or to humanely kill an animal if adverse effects cannot be alleviated, is an important means of limiting the severity of the protocol (see also V below). If the protocol stated that such measures could not or would not be employed, then it would be judged substantial. Taking steps to alleviate pain and distress either by treatment or by humanely killing an animal is intended to prevent substantial effects, and would usually result in application of a moderate severity limit.”
“Humanely killing an animal to comply with a moderate severity limit does not imply the procedure should be classified as substantial. This is explained fully in Dr Fry’s First witness statement (p13, para 41). I agree with the reasoning in this paragraph. If an animal has undergone a procedure that is classed as moderate, and the animal is developing problems that may cause it to exceed that severity limit, then action must be taken. This action may be to provide supportive care or administer treatments that can reduce or resolve the problem. If the treatment is not sufficiently effective, or if it is thought likely that such treatment is likely to be ineffective, then the animal should be humanely killed. This does not signify that the procedure should be classed as substantial, nor does it mean that the animal experienced effects that should be classed as substantial.”
“Protocols that may result in a major departure from the animal’s usual state of health or well-being”
“Mr Giffin’s basic premise is in my view erroneous. The guidance lays down an objective standard. It is a standard which requires the exercise of informed judgment in its application. It may be difficult to apply in practice, but the standard is not relative. A “major departure” from an animal’s state of health or well-being is a serious, significant or important departure, not “the most serious, significant or important departure which could lawfully be licensed”, the test implied by Mr Giffin’s submission and Dr Fry’s observations.”
“The second legal error was that he did not apply the “single animal” test required by the guidance to what he found had actually occurred. It is clear from his findings in paragraphs 5.C.15 to 19 and 5.C39 to 46 that the procedures had in fact resulted in a major departure from the usual state of health or well-being of a small number of animals. In consequence, he reached a conclusion which in my judgment was clearly wrong on that issue.”
“The main thrust of the [claimants’] criticism of Dr Richmond’s report is that, by reference to the evidence uncovered by its investigator and discovered in the facilities own records about seven named animals, his conclusions that the standard of care required by Condition 12 of the personal licence (already referred to) and Condition 8 of the Project Licence were fulfilled.”
“I can deal with this issue shortly. The general conclusion of his report, which dealt with a detailed and wide-ranging attack on the care of animals at the Cambridge Facility, was that it was a well-run facility, which provided a good standard of care, including post-operative care, for the animals within it. He found that project licence condition 8 had been breached in the case of two animals, Minnie and Tweety, which had suffered adverse effects of such duration and severity that they should have been killed promptly and the facts notified to the Secretary of State. The BUAV criticised Dr Richmond’s silence on the apparent lack of post-operative overnight monitoring of these animals and of others. Professor Flecknell and Dr Lewis, who has advised the BUAV, agree that in the case of these and other animals if there was no overnight monitoring the care provided was less than optimum. No records have been produced in the course of these proceedings which demonstrate that there was such monitoring, and Dr Richmond does not refer in his report to having seen any. But he does state that he was assured by the staff employed at the facility that overnight monitoring did occur, and he was entitled to accept that statement as true. Further, he checked the statement against the records that he had seen and concluded that there was no inconsistency between them. On the evidence produced to me it may not be a complete answer in the case of all seven marmosets, for example Agar who was found dead in the morning. In another case, Shazney, Professor Flecknell and Dr Lewis’ assumption as to what occurred is incorrect. They thought a craniotomy had been performed. In fact the records show it was an injection through a burr hole. I am not persuaded that Dr Richmond’s findings where made in relation to individual animals are irrational or clearly wrong. But even if I were to have been so persuaded, errors of detail in relation to a very small number of animals would not vitiate his overall conclusion. This amended ground of challenge does not accordingly succeed.”