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	England and Wales Court of Appeal (Civil Division) Decisions
You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Secretary of State for the Home Department v Campaign To End All Animal Experiments (t/a the British Union for the Abolition of Vivisection), R (on the application of) [2008] EWCA Civ 417 (23 April 2008) URL: http://www.bailii.org/ew/cases/EWCA/Civ/2008/417.html Cite as: [2008] EWCA Civ 417

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IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION ADMINISTRATIVE COURT
THE HON MR JUSTICE MITTING
CO/7004/2003

		Royal Courts of Justice Strand, London, WC2A 2LL
		23/04/2008

Lord Justice May:

Introduction

1. Some decisions of a public body taken under statutory authority are intrinsically less amenable to a successful judicial review application than others. These proceedings are an illustration of this. The British Union for the Abolition of Vivisection, as claimants, persuaded Mitting J that a Chief Inspector appointed by the Secretary of State under the Animals (Scientific Procedures) Act 1986 had misconstrued statutory Guidance when he reported in a Review of October 2002 on Aspects of Non-human Primate Research at Cambridge University; and that the Secretary of State made the same errors of misconstruction in adopting the Chief Inspector's Review. Mitting J made a declaration accordingly on 14^th September 2007, against which both the Secretary of State and the Chief Inspector appeal. The claimants cross- appeal from the judge's dismissal of another part of their case. Yet the nature of the claimants' case is to challenge a composite scientific judgment based more upon an expert analysis of scientific material than upon the application of hard-edged terms of a document amenable to lawyers' construction. The Guidance is susceptible to lawyers' analysis; but it is not a tax statute nor intrinsically difficult to understand. Its application requires scientific judgment. The scientific judgment is not immune from lawyers' analysis. But the court must be careful not to substitute its own inexpert view of the science for a tenable expert opinion. The appellants say that the judge was wrong to find that the Chief Inspector had misconstrued the Guidance; and wrong to find in consequence or at all that his Review reached a perverse conclusion. In my view, absent material misconstruction, the court should be very slow to conclude that this expert and experienced Chief Inspector reached a perverse scientific conclusion.
2. Mitting J's judgment may be found at [2007] EWHC 1964 (Admin). It may be referred to for details which I shall not need to repeat in this judgment.

The Animals (Scientific Procedures) Act 1986

3. The 1986 Act, which repealed the Cruelty to Animals Act 1876 (see section 27(1) of the 1986 Act), provides for the protection of animals used for experimental or other scientific purposes. It aims to protect animals from unjustified and unnecessary pain, suffering or distress and paragraph 5.42 of the Guidance on the Operation of the 1986 Act, published and presented to Parliament under section 21 of the Act, says that the Secretary of State will not license any procedure likely to cause severe pain or distress which cannot be alleviated. By section 10(2A) of the Act, licence conditions are to ensure that authorised procedures are carried out in accordance with Article 8 of Council Directive No. 86/609/EEC. This provides that, 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. One means of preventing unacceptable pain and suffering is by humane killing, for which appropriate methods are detailed in Schedule 1 to the Act.
4. Under the 1986 Act, a regulated procedure is one which may cause a protected animal pain, suffering, distress or lasting harm (section 2(1)). To determine whether a procedure may have this effect, the use of any procedure for rendering an animal insentient is to be disregarded, and such a procedure is itself a regulated procedure (section 2(4)). Humane killing is not a regulated procedure (section 2(7)). To be permitted to apply a regulated procedure, a person has to hold a relevant qualifying personal licence; the procedure has to have an authorising project licence specifying a programme of work; and the place has to be a designated establishment (section 3). A person who contravenes section 3 (or some other sections) is guilty of an offence (section 22(1)).
5. Section 4 provides for personal licences. Section 5 provides that a project licence

"… is a licence granted by the Secretary of State specifying a programme of work and authorising the application, as part of that programme, of specified regulated procedures to animals of specified descriptions at a specified place or specified places."

Section 5(3) restricts the purposes for which a project licence may be granted. Section 5(4) requires the Secretary of State, in determining whether or on what terms to grant a project licence, to weigh the likely adverse effects on the animals against the benefit likely to accrue from the specified programme. It is agreed that, for this and other purposes, humane killing is not an adverse effect. Section 5(5) places restrictions on the grant of a project licence. Section 5(6) places special restrictions on a project licence authorising the use of cats, dogs, primates or equidae.

6. By section 6, a place may be designated by a certificate of the Secretary of State as a scientific procedure establishment. The certificate has to specify a person responsible for the day to day care of the protected animals there, and a veterinary surgeon or other suitably qualified person to provide advice on their health and welfare (section 6(5)). If these persons are concerned about an animal's health or welfare, they have to notify the personal licence holder or, if this is not practical, to take steps to ensure that the animal is cared for and, if necessary, humanely killed (section 6(6)).
7. Section 18 requires the Secretary of State to appoint qualified medical or veterinary inspectors for the purposes of the Act. Section 18(2) and (3) provide:

"(2) It shall be the duty of an inspector-

(a) to advise the Secretary of State on applications for personal and project licences, on requests for their variation or revocation and on their periodical review;

(b) to advise him on applications for certificates under this Act and on requests for their variation or revocation;

(c) to visit places where regulated procedures are carried out for the purpose of determining whether those procedures are authorised by the requisite licences and whether the conditions of those licenses are being complied with;

(d) to visit designated establishments for the purpose of determining whether the conditions of the certificates in respect of those establishments are being complied with;

(e) to report to the Secretary of State any case in which any provision of this Act or any condition of a licence or certificate under this Act has not been or is not being complied with and to advise him on the action to be taken in any such case.

(3) If an inspector considers that a protected animal is undergoing excessive suffering he may require it to be immediately killed by a method appropriate to the animal under Schedule 1 to this Act or by such other method as may be authorised by any personal licence held by the person to whom the requirement is addressed."

8. Section 19 establishes the Animal Procedures Committee whose duty under section 20 is to advise the Secretary of State on such matters concerned with the Act and his functions under it as the Committee may determine or as may be referred to it by the Secretary of State.
9. By section 9, the Secretary of State has to consult one of the inspectors, and may consult an independent assessor or the Animals Procedures Committee, before granting a licence or a certificate. Section 10(1) provides that a licence or certificate may contain conditions. By section 10(2), a personal licence has to include a condition requiring the licence holder to take precautions to prevent or reduce to the minimum consistent with the purposes of the authorised procedures any pain, distress or discomfort to the animals; and an "inviolable termination condition" specifying circumstances in which a protected animal must be killed humanely. See also section 10(3D) for obligatory conditions of a project licence. The conditions of a certificate for a designated establishment under sections 6 and 7 have to include appropriate conditions for the general care and accommodation of protected animals, including appropriate conditions to ensure:

"(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."

10. Appendix B to the Guidance contains standard conditions for designated scientific procedure establishments. These include that the establishment has to be appropriately staffed at all times to ensure the well being of the protected animals (paragraph 4); that records have to be maintained, in a format acceptable to the Secretary of State, of the source, use and final disposal of all protected animals accommodated at the establishment for experimental or other scientific purposes (paragraph 5); and that records have to be maintained, in a format acceptable to the Secretary of State and under the supervision of the Named Veterinary Surgeon relating to the animals' health (paragraph 7).
11. Appendix D to the Guidance contains standard conditions for project licences, breach of some of which (but not condition 6) may be criminal offences under the Act. Condition 6 provides that, for any procedure, the degree of severity imposed shall be the minimum consistent with the attainment of the objectives of the procedure, and that this shall not exceed the severity limit attached to the procedure – see below for severity limits. By condition 8, it is the responsibility of the project licence holder to ensure adherence to severity limits as shown in the listing of procedures or protocols. Condition 9 makes it the responsibility of the project licence holder to maintain a contemporary record of all animals on which procedures have been carried out. By condition 14, the project licence holder has to ensure that all personal licence holders carrying out regulated procedures have the appropriate level of supervision. By condition 16, at the conclusion of a series of regulated procedures, protected animals which are suffering, or are likely to suffer, as a result of the procedures have to be promptly and humanely killed – see also paragraphs 8, 9 and 10 of Appendix E, which contain standard conditions for personal licences.
12. By condition 12 of Appendix E to the Guidance, personal licensees are entrusted with primary responsibility for the welfare of animals on which they have performed regulated procedures; and they must ensure that the animals are properly monitored and cared for. It is their responsibility to notify the project licence holder as soon as possible when it appears either that the severity limit of any procedure or constraints upon adverse effects described in the protocol sheets have been or are likely to be significantly exceeded (condition 13). Project licensees have to maintain a record of all animals on which procedures have been carried out (condition 21).

The Guidance

13. The Guidance is a substantial document. Chapter 5 concerns Project Licences. It explains that a single project licence is expected to cover a coherent programme of work managed by an individual to meet a common set of well-defined objects. A licence may therefore range from one covering a large drug discovery process, involving a large number of animals of a wide range of species, to the work of a single scientist using a small number of animals of a single species (paragraph 5.3). A project licence gives details of the objectives, likely benefits, the plan of work and the experimental or other scientific protocols. It also:

"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."

Paragraphs 5.18 and 5.19 provide:

"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."

14. Under the heading "Protocol Severity Limits", paragraphs 5.40 to 5.42 provide:

"5.40 The severity limit for each protocol is determined by the upper limit of the expected adverse effects that may be encountered by a protected animal, taking into account the measures specified in the licence for avoiding and controlling adverse effects. It represents the worst potential outcome for any animal subjected to the protocol, even if it may only be experienced by a small number of the animals to be used.

5.41 In assessing the severity limit of a protocol, account should be taken of the effect of all the procedures (whether regulated or not) applied to each animal or group of animals; the nature and extent of the likely adverse effects; the action taken to mitigate these effects; and the humane endpoints to be applied.

"5.42 The severity limits of the protocols in the licence are categorised as follows:

Unclassified

Protocols performed entirely under general anaesthesia, from which the animal does not recover consciousness. This includes the preparation and use of decerebrated animals.

Mild

Protocols that, at worst, give rise to slight or transitory minor adverse effects. Examples include: small infrequent blood samples; skin irritation tests with substances expected to be non-irritant or only mildly irritant; minor surgical procedures under anaesthesia such as small superficial tissue biopsies or cannulation of peripheral blood vessels. However, if used in combination or repeated in the same animal, the cumulative severity may be increased beyond mild. Protocols may also be regarded as mild if they have the potential to cause greater suffering but contain effective safeguards to initiate effective symptomatic or specific treatment or terminate the protocol before the animal shows more than minor adverse effects.

Moderate

Protocols regarded as moderate include toxicity tests (which do not involve lethal endpoints) and many surgical procedures (provided that suffering is controlled and minimised by effective post-operative analgesia and care). Protocols that have the potential to cause greater suffering but include controls which minimise severity, or terminate the protocol before the animal shows more than moderate adverse effects, may also be classed within the moderate severity limit.

Substantial

Protocols that may result in a major departure from the animal's usual state of health or well-being. These include: acute toxicity procedures where significant morbidity or death is an endpoint; some efficacy tests of anti-microbial agents and vaccines; major surgery; and some models of disease, where welfare may be seriously compromised. If it is expected that even one animal would suffer substantial effects, the procedure would merit a 'substantial' severity limit.

The Secretary of State will not license any procedure likely to cause severe pain or distress that cannot be alleviated [Section 10(2A)]."

15. Thus when a project is to be licensed, a predictive assessment has to be made by which its protocols are given one of four severity limits. Paragraph 5.41 is largely self-explanatory as to what should be taken into account. Paragraph 5.40 requires the assessment to be made with reference to the upper limit of the expected adverse effects, representing the worst potential outcome even for a small number of the animals to be used. Measures to avoid, control or mitigate adverse effects are to be taken into account. The "unclassified" category, under which a procedure is performed on an unconscious animal which never recovers consciousness, may be put to one side for present purposes. The other three categories represent a progression of severity. The progression does not reach a procedure likely to cause severe pain or distress which cannot be alleviated, because the Secretary of State will not license such a procedure. The dividing lines between the "mild" and "moderate", and between the "moderate" and "substantial" categories are more a matter of scientific judgment than legal analysis; and a legalistic over-analysis of individual words will tend to obscure what should be a composite comparative scientific assessment with reference to the whole of at least 10 lines of the text of the Guidance – as printed, the "moderate" and the "substantial" categories each have more than 5 lines of text, and the "mild" category has 8 lines.
16. Paragraphs 5.43 to 5.46 are under a heading "The Severity Condition". Licence holders are required to minimise any pain, suffering, distress or lasting harm. They should approach the limit of severity only when it is absolutely necessary to meet the specified objective. If it seems likely that a severity limit has been or may be exceeded, the Home Office must be contacted, whereupon the Secretary of State may temporarily authorise a higher severity limit.
17. Paragraphs 5.47 to 5.49 of the Guidance provide for the "Overall Severity Band of a Project" as follows:

"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."

18. Thus the severity band of a project may not be as severe as the severity limits of some of its protocols, because severity limits have to represent the worst potential outcome for any animal, but the severity band is based on the overall level of cumulative suffering, not just the single worst possible case. Paragraph 5.49 requires reassessment during the lifetime of a project. This will obviously take account of what actually happens when protocols are put into operation, in contrast with the predictive assessments required for categorisation when the licence is first granted.
19. Although the general purpose of severity limits and severity bands appears obvious, their detailed utility might possibly be questioned. The judge considered this in some detail in paragraphs 25 and 26 of his judgment. What he said is not challenged and it is not necessary to repeat or summarise it. The judge's conclusion in his paragraph 27 was:

"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."

I would only add generally for present purposes that determining protocol severity limits initially and reconsidering them in the light of experience are important aspects of the protection for the animals which the legislation and Guidance require.

The project licences

20. In June 1998, the Secretary of State granted three project licences under the 1986 Act to scientists at the Cambridge University Department of Experimental Psychology. They were for experiments on marmosets, which are primates, to further research into the functioning of the human brain and illnesses affecting it, such as stroke, Parkinson's disease and Huntingdon's Chorea. The experiments included procedures intended to induce stroke or brain damage by surgery or other means. In 2003, two of the licences were renewed under different numbers. One of these was licence number PPL80/1249. The judge concentrated on this licence only – see paragraph 29 of his judgment. The application and licence had 7 protocols, 6 of which were categorised with a severity limit of "moderate", the seventh having a severity limit of "mild" .

The claimants' challenge

21. Between March 2001 and January 2002, the claimants conducted an undercover operation at the Cambridge Experimental Psychology department. As a result, the claimants believed and contended that the applications and licences had miscategorised the adverse effects of the most severe procedures as "moderate", when they should have been "substantial", and that there had been significant breaches of the licence conditions. They reported their belief to the Secretary of State, who appointed the Chief Inspector under the 1986 Act, Dr Jon Richmond, to investigate and report. He did so and reported in October 2002. His Review was published in February 2003. His conclusion was that there had been no wholesale breach of licence conditions.
22. By letter dated 1^st October 2003, the Secretary of State stated that he intended to take no action. These proceedings, started just within 3 months of that letter, formally challenged that decision. They were started well out of time for a straight challenge to the decision of the Chief Inspector, who was not at that stage a defendant. The claim form was subsequently amended three times, latterly to add the Chief Inspector as defendant. The Secretary of State, by Respondents' Notice, formally seeks to appeal against this decision on the ground that the application to add the Chief Inspector was made hopelessly late and when the requisite large extension of time would not have been given initially at the permission stage.
23. The substance of the claimants' claim was, I think, always a challenge to the Secretary of State's Inspector. In the light of the view I take of the integrity and rationality of that decision, it is not in my view necessary to debate what might be a nice distinction between the rationality of the Chief Inspector's decision and the rationality of the Secretary of State's decision to accept the Chief Inspector's advice; nor to determine the academic question whether the judge was wrong to permit the amendment in question.

Licence PPL80/1249

24. The application for licence PPL80/1249 described the background, objectives and benefits in four closely typed A4 pages. In the simplest terms, there were three approaches to reducing the burden of human brain dysfunction by prevention, treatment and repair. The plan of work was then described in three typed pages under these three headings describing for each specific experiments. Detailed technical flow diagrams showed what procedures would be used, each concluding with humane killing of the animals. For each of the 7 protocol procedures, information was given for determining the severity limit, which among other things, described the procedure and the possible adverse effects. By way of example, protocol sheet 2 began its technical description of the procedure as follows:

"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."

There followed 17 more lines of technical description.

25. The possible adverse effects were given as follows:

"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."

26. As I have said, this and 5 other protocols were categorised in the project licence as having a "moderate" severity limit.

The Chief Inspector's Review

27. The Chief Inspector's Review of October 2002 concluded that the severity bands for the three Cambridge project licences and the associated severity limits for the component protocols were properly assigned. In the context of the claimants' allegations of non-compliance and their concern about standards and practices at the Cambridge establishment, Dr Richmond concluded, among other things, that it was generally well managed and provided appropriate standards of accommodation and care for the animals; that the standard of record keeping was good; and that the establishment was adequately staffed. Having scrutinised details of all procedures extending back to 1998, he identified four instances of non-compliance with licence authorities. He made certain general and specific recommendations.
28. In assessing the appropriateness of the severity bands and severity limits, Dr Richmond described what he referred to as their minor role – a view with which the judge did not entirely agree. Dr Richmond stated (no doubt correctly) that judgments about the level of suffering that might be produced and the humane endpoints to be applied are judged by the detailed narrative descriptions, not by shorthand severity limits.
29. As to severity limits for project licence PPL80/1249, he said that 5 of the 6 "moderate" protocols were so classified on bases which included that the resulting neurological defects were expected to be transient and thereafter only demonstrable on formal testing; or that any persisting, stable neurological deficit would not prevent the animals from undertaking their normal activities of daily living. If more severe adverse effects were seen the problem would be promptly identified and remedied. The sixth "moderate" protocol allowed for surgical removal of tissue under general anaesthesia and with recovery. The seventh was assigned a "mild" severity limit (and was not the subject of debate in this court). Dr Richmond quoted the substantial terms describing the "moderate" severity limit in paragraph 5.42 of the Guidance, expressing the opinion that the severity limits assigned accorded with this Guidance. He expressed an equivalent opinion for each of the other two project licences. He further expressed the opinion that the severity bands for each of the project licences were compliant. Having considered further material submitted with the original applications, he noted that the claimants' material contained no relevant material which undermined the judgment. He concluded that the original licensing decisions were sound and defensible.
30. As I understand it, this part of Dr Richmond's decision is challenged in these proceedings in one particular only, which the judge upheld and which the appellants challenge on appeal. It is said that because, for example, a possible adverse effect in the second protocol of PPL80/1249 was persistent epilepsy requiring the animal to be killed, this must be "a major departure from the animal's usual state of health or well being", and that therefore the protocol should have been assigned a "substantial" severity limit. It is accepted that humane killing is not itself an adverse effect; and accepted perhaps that there may be degrees of persistent epilepsy, not all of which would necessary predicate a "major departure etc …". But if the persistent epilepsy is such as to require humane killing, that must necessarily predicate a major departure.
31. Dr Richmond then reviewed the performance in practice of the Cambridge establishment to see if they had complied with the terms and conditions of the relevant certificate and project licences and with best contemporary practice.
32. He sought confidential advice, opinion and information from other experts to compare the performance at Cambridge with practice at other places. He interviewed staff at Cambridge and looked at their records and other documents. He observed anaesthesia, surgery and post operative care. He noted that the Home Office had invited the claimants to provide the evidence on which their concerns were based and to allow their interviewer to be examined; but the claimants declined.
33. Dr Richmond considered that the record keeping could be regarded as good or best practice. In a section on staffing levels and standards of animal care, he noted that the Named Veterinary Surgeon organised good screening and investigative services, advised on the regulated procedures applied and the after care provided and was available for help and advice as and when required. Detailed advice and treatment records were maintained. The level and quality of service had much to recommend it (paragraph 5.A.24).
34. The Review has sections addressing criticisms by the claimants under various headings. One such is "Post Operative Care" in which Dr Richmond noted that, in common with other designated establishments, staff and personal licensees were expected and required to provide monitoring and care based on the perceived needs of the animals, but not necessarily to be present 24 hours a day. The lack of 24 hour cover raised important issues, particularly in relation to the care of animals in the early post-operative period. At paragraphs 5.B.30 and 31, Dr Richmond wrote:

"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."

35. Dr Richmond considered the three Project licences including PPL80/1249 in some detail in section 5.C of the Review. He described the procedures. In the "Stroke Studies" section, he noted that all but two animals had recovered from the operation quickly enough to be returned to their home cage in two or three days. There had been two deaths within six hours of surgery and a further two deaths several weeks after the surgery from cerebral haemorrhages. The procedure resulted in impaired use of one hand or arm, but without evident weakness or paralysis requiring the provision of special care because the animal could not undertake the normal activities of daily living. Animals with established lesions appeared at first sight to be almost normal.
36. Under the heading "Post-Operative Care", Dr Richmond noted that the analgesic regime had been periodically reviewed and revised in consultation with the Named Veterinary Surgeon. There seemed to be no case where an appropriate post-operative assessment of the animal was not made or when analgesics were not given if signs indicative of pain were detected and recorded. Under "Adverse Effects Encountered", Dr Richmond noted records which confirmed that, since the project licence was granted, approximately 4% of the animals used for the project had died or been humanely killed on welfare grounds. He noted that some seizures did occur, generally spinal jerks or Jacksonian rather than grand mal. Following the production of bilateral thalamic excitotoxic lesions, two animals did not recover (which we were told had not been expected). One died while under general anaesthesia and the other within 24 hours of surgery. The protocol was amended and the problem did not recur. One animal with a persistent form of bilateral infero-temporal lesions was humanely killed as it was not considered a suitable research subject.
37. I pause to say that, in the context of a judicial review challenge, I have summarised what appear to be salient points of an expert scientific analysis necessarily without any real personal competence to reach a judgmental conclusion as to the opinions underlying what is said.
38. Dr Richmond made a comparable review of the other two project licences, noting in the case of one of them that unexpected animal welfare problems were encountered which should have been notified to the Home Office as a breach of the severity limit, but were not. Two animals were humanely killed. The research group sought expert technical advice before amending the surgical technique. No further problems were encountered.

The judicial review claim

39. The amended claim form sought a variety of declarations, the first of which was that the Secretary of State had acted unlawfully in his decision of 1^st October 2003 that none of the three Cambridge Protocols should have been given a "substantial" severity limit and that he had misconstrued the Guidance. By amendment, an equivalent declaration was sought against the Chief Inspector. The shortly expressed ground in support of this was that the Secretary of State and the Chief Inspector misapplied the statutory guidance and made a perverse decision that all the severity limits for the protocols were correct. Other claimed declarations were not pursued or, except to the extent referred to below, did not carry through into the judge's judgment or on appeal to this court.
40. Speaking generally, there appears at times to have been some confusion as to whether the challenges were on the grounds of perversity or because it was said that the Secretary of State or the Chief Inspector had misconstrued the statute or the Guidance. As presented to this court, the argument in part appeared to be that, since a perversity challenge was said to have been met by an argument of construction which was mistaken, the Secretary of State or the Chief Inspector must be taken to have proceeded on the basis of that misconstruction.
41. I say at once that I have failed to detect any error of law in the Chief Inspector's Review (which the Secretary of State adopted) constituting a misconstruction of the statute or the Guidance; and that I should be most reluctant to conclude that the Chief Inspector's expert opinion was perverse on a scientific subject such as this. In broad terms and in large measure, the Chief Inspector's conclusions were supported before the judge by evidence from Dr Richmond's successor as Chief Inspector, Dr Fry, and by the expert opinion of Professor Flecknell. There are some qualifications to the latter, but they provide scant foundation for a finding of perversity in judicial review proceedings.
42. The judge's order was in form limited to a declaration that the Chief Inspector and the Secretary of State had misconstrued paragraphs 5.40 to 5.42 of the Guidance. The rest of the claim was dismissed. The judge's reasoning in paragraph 43 of his judgment was that Dr Richmond's conclusion that all the protocols in PPL80/1249 were correctly categorised was vitiated by legal error and was clearly wrong. This might be read as a finding of putative perversity once the legal errors are corrected. But to my mind, even if you accept the legal errors identified by the judge (which, as will appear, I do not), they do not inevitably lead to a finding of perversity.
43. The live issue which the judge identified was whether the Secretary of State should have required a "substantial" severity limit to be applied to some of the protocols in PPL80/1249 in the light of the procedures described in the protocols and in the light of Dr Richmond's findings as to what had occurred in practice. The underlying question was whether the Secretary of State's officials had applied the correct test. There were in fact in theory at least two rather different possible questions, the first relating to the decision when the licence was granted, the second to the facts as disclosed in Dr Richmond's investigation. For the first of these, the question was what degree of severity was expected for the procedures described in the protocols. For the second, the expected severity may have been shown to be wrong in the light of experience; and there was also and separately the possibility of a breach of the licence conditions. This would not necessarily require the severity limits to be reassessed if, for instance, appropriate adjustments were made to the procedures. The claimants have, I think, tended to conflate the two questions. The main burden of their complaint relates to the procedures as they were in fact carried out.
44. The judge said that the underlying issue was of general importance. He said at paragraph 31 of his judgment:

"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."

45. The judge then referred to what Dr Richmond had reported happened in practice and quoted paragraphs 5.C.15 to 19 and 5.C.39 to 46 of the Review (which I have more briefly summarised above). The judge noted that the claimants contended that Dr Richmond had understated the anticipated and actual outcomes of the procedures. Judicial review proceedings were not an appropriate means of resolving such issues. Unless irrationality was clearly demonstrated, the judge must and did accept Dr Richmond's findings as to what did in fact occur.
46. Paragraph 35 of the judgment has 7 sub-paragraphs expressed to be conclusions as to the construction of paragraphs 5.40 to 5.42 of the Guidance. These may be referred to and I need not repeat or summarise all of them. They included that avoiding or controlling otherwise adverse effects by anaesthetic or otherwise was relevant to assessing a severity limit and could result in a "moderate" categorisation for what might otherwise have been "substantial". The criterion for classifying a procedure with a "substantial" severity limit was that contained in the first sentence of the relevant paragraph. The judge agreed that humane endpoints were relevant and that death itself is not an adverse effect.

"But [death] is not irrelevant to the setting of a severity limit. The draftsman clearly had in mind that the nature of the "endpoint", humane or otherwise, was a relevant factor, hence the reference to "the humane endpoints to be applied" in 5.41 and to "acute toxicity … where significant morbidity or death is an endpoint" in the explanatory definition of "substantial" in 5.42. Where the adverse effects of a procedure can only be controlled by killing the animal, that is a clear indication that a higher severity limit is justified than when the adverse effects can be controlled by analgesics. I would put the threshold somewhat lower: when it is not clear that measures short of killing will be or have in practice proved to be effective at controlling adverse effects, anticipation of the use of killing as a means of control is an indicator of severity."

47. In paragraph 43, the judge said that Dr Richmond's conclusion, in the light of his findings as to what was proposed and what had in fact occurred, that all the protocols in PPL80/1249 were correctly categorised, was vitiated by legal error and was clearly wrong. The first legal error was that he did not accept that adverse effects severe enough to require the animal to be killed, rather than treated by means short of killing, were capable of amounting to major departures from health or well-being. This was implicit in paragraph 4.18 of Dr Richmond's report where he had observed that:

"… 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."

48. The only remedial means available in those circumstances was killing the animal which, for reasons which the judge had explained, is an "indicator" of severity.
49. In paragraph 46 of his judgment, the judge referred to paragraph 35 of Professor Flecknell's "cautious" report as being founded on a somewhat different premise from that accepted by the judge as to the effect of killing as a means of controlling adverse effects. The relevant part of Professor Flecknell's report is as follows:

"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."

Professor Flecknell also said at paragraph 39 of his report:

"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."

The Secretary of State's grounds of appeal

50. The Secretary of State's first ground of appeal challenges the judge's finding as to the effect of anticipated killing on the categorisation of severity limits. There was some discussion before us as to exactly what the judge did here decide. Mr Drabble's submission was that the judge had decided no more than that, if humane killing was an anticipated possibility, that was capable of amounting to a major departure from usual health or well-being, but did not necessarily do so. It was no more than an "indicator". The claimants' case, I think, is not that expected persistent epilepsy requiring humane killing must have a substantial severity limit simply because killing is the anticipated endpoint; but that it is perverse not to regard expected persistent epilepsy as a major departure from usual health and wellbeing in any event, but especially when the anticipated endpoint is killing. In the simplest terms, persistent epilepsy is obviously severe; if you have to kill the animal because of it, it is even more obviously severe.
51. If this were the only intent of the judge's decision, it would not amount to very much. I acknowledge that the judgment might be read in this limited way, but I am not persuaded that this was its limit. If it were, it is difficult to elevate it to a legal error capable of vitiating Dr Richmond's professional judgment – this especially when it is not readily apparent that Dr Richmond made this (or any related) legal error in forming his opinion. This problem, incidentally, pervades both matters which are the subject of the Secretary of State's appeal, and has the tendency of making the appeal an anchorless – and arguably illegitimate – lawyer's seminar, rather than a directed attack on an actual decision said to be erroneous.
52. If the error were limited to failing to take account of the potential, but not necessarily determinative, relevance of humane killing, that would not necessarily by itself and without further analysis vitiate the resulting conclusion.
53. I am persuaded by Mr Giffin's submission on behalf of the Secretary of State that the judge was wrong, if he decided that anticipated humane killing is an indicator of severity in the sense that it would require a severity limit of "substantial". He was also wrong if he decided that anticipated humane killing will always be a significant indicator, though not necessarily decisive, of "substantial" severity. Humane killing is not, as the judge and parties agree, itself an adverse effect. The fact that it is anticipated is a relevant part of the large picture, but no more. The reference to "humane endpoints" in paragraph 5.41 (which is not limited to humane killing) implies no more than that humane killing should be taken into account where appropriate. The purpose of humane killing is to prevent or bring an end to what would otherwise be adverse effects. It is a matter of expert scientific judgment whether the state of the animal before it is humanely killed would comprise adverse effects which require a "substantial" severity limit; or, for that matter, a "moderate" severity limit, since the risk of exceeding a "mild" severity limit might be avoided by humane killing – see the reference in the "mild" categorisation to terminating the protocol "before the animal shows more than minor adverse effects." The fact that the animal is then to be killed humanely does not necessarily contribute to that judgment. That is the effect of the relevant parts of the evidence of Dr Fry (paragraph 41) and Professor Flecknell (as quoted above). The evidence also explains that an animal may be killed humanely for reasons other than those relating to its health or welfare. It is also the logical consequence of the accepted facts that humane killing is not itself an adverse effect; that its purpose is to prevent or control adverse effects; and that where adverse effects are prevented or sufficiently controlled a "moderate" severity limit may be appropriate. The references to "humane endpoints" in paragraph 5.41 and to "acute toxicity procedures where … death is an endpoint", neither of which necessarily equate with or predicate humane killing, do not in my view detract from this analysis.
54. The claimants' written submissions on this issue suggest firstly, as I have said, that the judge decided no more than that anticipated humane killing was capable of being an indicator of "substantial" severity. I disagree for the reasons which I have given. They then refer to examples of cases in which an animal in fact died in the course of a procedure. Although that fact may be relevant to a need for modifying the protocol or to reassess its severity, unexpected death (as distinct from the anticipated possible need for humane killing) was not the judge's main consideration under this issue. The submissions then had extended references to parts of the protocols where particular possible adverse effects are anticipated with humane killing as the endpoint – for example, persistent epilepsy. It is suggested that some of the adverse effects so obviously require a "substantial" severity limit that Dr Richmond must have been wrong to decide otherwise. These are perversity arguments which the judge did not address. He could not legitimately have done so in the face of Dr Fry's and Professor Flenkell's evidence to the contrary without an extensive analysis which he simply and understandably did not attempt – understandably, because such an analysis of apparently competent expert scientific opinion would not have been a proper subject of judicial review proceedings. Stanley Burnton J's shortly expressed view, upon the permission application in this case in 2005, that an animal with persistent epilepsy will already have suffered a major departure from its usual state of health – that is why it is killed – has an intuitive attraction, but does not accord with one apparently tenable view of expert scientists that Jacksonian epilepsy not amounting to grand mal may be classified as of "moderate" severity in this context, and that anticipated humane killing in these circumstances does not predicate otherwise. The judge did not decide that Dr Richmond made freestanding perverse scientific judgments and there is no Respondent's Notice to support a submission that he should have so decided.
55. The Secretary of State's second ground of appeal, expressed compendiously, is that the judge was wrong to hold as a matter of law that the protocols of procedure PPL80/1249 should have been classified as having a "substantial" severity limit. There are a number of strands of this in the written grounds of appeal. It is said that the judge was wrong to find that Dr Richmond had failed to apply the "single animal test" required by the Guidance when there was no proper basis for this finding, and when the real basis of the judge's finding was his own view that on the facts the procedures had in fact resulted in a major departure from the usual state of health or wellbeing of a small number of animals. This view, it is said, was based in part on the false premise that anticipated humane killing or the death of an animal in the course of a procedure necessarily meant that it had suffered a major departure from its usual state of health or wellbeing – this being the first ground of appeal. The judge's view was also founded on his rejection of the proposition that deciding whether there was a "major" departure required a comparison of the expected effects of the procedure with those of other procedures for which a licence might be granted. It is said that the judge failed to take account of the fact that the occurrence of an event did not necessarily mean either that it was expected when the licence was granted, nor expected to occur again in the future. It is said that the judge was wrong to reject the conclusion of Professor Flecknell's expert report when, possible errors of law apart, there was no proper basis for doing so. The judge could not properly have held that a "substantial" severity limit was the only conclusion open to the Chief Inspector on the facts.
56. I have already indicated that in my view the judge did not hold (or if he did, could not properly have held) that Dr Richmond's scientific judgments were perverse. He held that they were vitiated by two legal errors, the second of which I now examine.
57. The opening sentence of the passage in the Guidance describing the "substantial" severity limit is:

"Protocols that may result in a major departure from the animal's usual state of health or well-being".

Non-exhaustive examples are then given whose nature will help the scientific expert to determine whether a protocol should have this severity limit. The final sentence then says that, if it is expected that even one animal would suffer substantial effects, the procedure would merit a "substantial" severity limit. The expert will also be helped by the description of the "moderate" severity limit; so that many surgical procedures may be of "moderate" severity provided that suffering is controlled and minimised by effective post-operative analgesia and care. Protocols with the potential to cause greater suffering may be categorised as of "moderate" severity if they include controls which minimise severity, or terminate the protocol before the animal shows more than moderate adverse effects. The description of the "mild" category may also help, even if the categorisation does not come within that category. The scientific expert must form a judgment as to which of these categories should apply. Much of the language is not technical, but the scientist will not derive much real help from the lawyer in making the necessary judgment. This is not, after all, a tax statute. Pages of cerebration about the meaning of the ordinary words, "mild", "moderate", "major" and "substantial" are not likely to help.

58. The judge understood Mr Giffin to have submitted, on the common understanding of Dr Fry and Dr Richmond, that the key word was "major" and that this denotes a relative concept. The "substantial" limit is reserved only for procedures producing the most severe effects. Anything less is moderate or mild, omitting the unclassified limit which was irrelevant to the issue. The judge then referred to two passages in the evidence to which I shall return. He then said in paragraph 40 of his judgment:

"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."

It is perhaps over captious to observe that, whatever merit the judge's substitution for "major departure" of "serious, significant or important departure" may have, he was logically wrong to reject the proposition that the "substantial" severity limit represented the most serious, significant or important departure which could lawfully be licensed. That is precisely what the "substantial" severity limit is. Procedures likely to cause severe pain or distress that cannot be alleviated will not be licensed.

59. The judge rejected, as I would, a supportive contention that it was better for an animal to be subjected to a procedure classified as "moderate" because departure from it would require a report to the Home Office which a classification of "substantial" would not require.
60. The judge correctly stated that in practice there has to be an exercise of judgment; and that the views of scientists and veterinary surgeons who make the judgment must be given proper respect up to the point at which their judgment can be shown to be vitiated by legal error or clearly wrong.
61. I have already addressed the judge's first legal error. As to the second legal error, the judge said:

"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."

This is a condensed paragraph whose import is not entirely clear. It is not clear whether the judge is saying that Dr Richmond's opinion is unsupportable because he made an error of law or because he reached a perverse conclusion. I do not myself think that it can be the second of these, because it would not be a sustainable judicial exercise to reject many pages of technical scientific opinion as perverse in a single sentence. The judge's conclusion is said to depend on a legal error in not applying "the single animal test".

62. The "single animal test" must derive from the last sentence of the description of the "substantial" severity limit. This refers to what is expected, not what happened. The paragraphs of Dr Richmond's Review to which the judge referred relate as the judge indicated to what happened. They provide no basis for saying that the original classification when the licence was granted based on what was expected was wrong, let alone obviously wrong, since they provide no basis for saying that what happened was expected. There may however properly be asked the different question whether Dr Richmond was wrong not to conclude that, in the light of what happened, the severity limits needed to be reassessed.
63. As to that question, the paragraphs to which the judge refers state that, for the stroke studies, there were two deaths within 6 hours of surgery and two more deaths several weeks after surgery from cerebral haemorrhage (paragraph 5.C.17). The section of the Review under the heading "Adverse Effects Encountered" describes various such effects, together requiring an exercise of judgment. Paragraph 5.C.44 notes that two animals died within 24 hours of surgery, and that the protocol was amended and the problem did not recur. In this context, the judge's reference to the single animal test must relate to the fact that a small number of animals died as described in the paragraphs to which he refers. Yet one or more expected deaths do not by themselves vitiate the original judgment as to severity limits when the procedure was licensed; nor do a small number of deaths necessarily vitiate the continuance of the original severity limit, if the protocol was amended to take account of what happened and the problems did not recur. I do not consider that these paragraphs show that Dr Richmond misapplied the single animal test, not least since he had correctly quoted the relevant passage earlier in his review.
64. There was some confusion at the hearing of the appeal as to what submission on behalf of the Secretary of State as to the construction of the first sentence of the substantial severity limit the judge had rejected. It centred around the meaning of the word "major" which the judge understood Mr Giffin to say should be construed as denoting a "relative" concept. But relative to what? Mr Giffin says there is a spectrum. I agree, if by that is meant a progression from protocols which should be classified as having a "mild" severity limit to those having a "substantial" severity limit, taking in the "moderate" severity limit on the way. But that derives from the whole of paragraph 5.42, not from introspection about the deeper meaning of the word "major". The progression of the three severity limits may be telegramatically labelled as a progression from "minor" to "moderate" to "major", but that by itself does not tell you much. What is "minor", "moderate" or "major" [or "mild", "moderate" or "substantial"] is to be determined by a scientific judgment having regard to the contents of the paragraph as a whole. What is judged to qualify as "mild" may help to determine what should qualify as "moderate" and so forth.
65. Without quarrelling unduly with the judge's substitution of "serious, significant or important" for "major" in the first sentence of the "substantial" severity limit description, I would be inclined to let the actual words speak for themselves. I agree with Mr Drabble, so far as it goes, that they mean what they say, but they must be taken in their full context of the whole of paragraph 5.42. I do not consider that Dr Richmond's Review can be shown to have proceeded on an erroneous construction of the first sentence in its full context. Mr Drabble did not submit that, taken alone, it could. He submitted, however, that the Secretary of State defended the claimants' perversity case upon an argument as to the "relative" meaning of the word "major" which was wrong; and that it was this argument which the judge rightly rejected. The argument, it is said, derived from the passages in the evidence quoted in paragraphs 37 and 38 of the judgment. In the first of these Dr Fry had given a "paradigm example" of a procedure requiring a "substantial" severity limit. In the second, Dr Fry said no more than that a major departure from the animal's usual state of health or wellbeing should be interpreted as referring to a higher order of pain, suffering or lasting harm than is catered for by the "moderate" severity limit. Mr Drabble then referred to paragraphs 78 and 79 of Mr Giffin's written submission for this appeal as constituting a rewriting of the Guidance. Mr Giffin there referred to a description of a procedure which deliberately produced full blown Parkinson's disease in non-human primates. His written submission then was that it must be appropriate to apply the system of severity limits in a manner which allows a distinction to be drawn between cases such as this, and the very different type of procedures in question in this appeal. Lumping them all together as producing major effects and therefore as requiring a "substantial" classification is counterproductive. Mr Drabble says that the effect of this, and the way in which the Secretary of State operates generally in practice, is to reserve the "substantial" severity limit for a handful of procedures having very severe adverse effects only, and to exclude other procedures which properly and naturally come within the plain wording of the first sentence of the "substantial" description. Mr Giffin disclaims this on the behalf of the Secretary of State, although one view of paragraph 78 and 79 of his written submission and paragraph 5(b) of the Grounds of Appeal would suggest otherwise. It looks as if the judge thought that Mr Giffin's submission was along the lines suggested by Mr Drabble. But the paragraphs of Mr Giffin's submission in this court which precede paragraphs 78 and 79 show that his main submission was that a major departure has to be judged in the context of paragraph 5.42 as a whole, including the descriptions of "mild" and "moderate" severity and the progression from one severity limit to the next.
66. However that may be, the discussion has drifted towards an anchorless seminar. In my judgment, Dr Richmond's review is not shown to have proceeded on an error of law as to the meaning and application of the first sentence of the description of the "substantial" severity limit, which is, so far as it goes, by definition the most serious, significant or important departure which can lawfully be licensed. The application of the "single animal test" to Dr Richmond's findings did not, as a matter of law, require a determination that the "substantial" severity limit should have been applied when the licence was granted, nor that it should have been applied upon reassessment following Dr Richmond's findings. Dr Richmond is not shown to have made an error of law as to the relevance of humane killing or death for the purpose of determining severity limits. The judge did not find that Dr Richmond's opinions were wrong other than because, in his view, Dr Richmond made errors of law. He did not find that, absent the imputed errors of law, Dr Richmond's conclusions were perverse. He could not in the circumstances have properly done so without an intense analysis of expert scientific material which he rightly did not attempt to undertake. Since, as I have indicated, Dr Richmond is not shown to have proceeded upon either of the legal errors identified by the judge, the judge's decision that Dr Richmond's conclusion was clearly wrong cannot stand.
67. The judge's substitution of "serious, significant or important departure" for the words "major departure" is innocuous, but unnecessary. The words of the first sentence mean what they say in the full context in which they appear. Their application is a matter of scientific judgment. If the Secretary of State, by reserving the "substantial" severity limit for the most severe procedures only without proper reference to the text of paragraph 5.42, excludes from that classification procedures which ought upon proper scientific judgment to fall within it, he is necessarily wrong to do so. It is beyond the competence of this court on the material before it to say whether the Secretary of State does this or not.
68. In the result, I would allow the Secretary of State's appeal.

The claimants' cross-appeal

69. The second ground for judicial review was that the Secretary of State and the Chief Inspector misdirected themselves in law or made a perverse decision that the licence holders' arrangements for checks and care enabled them to discharge their duties under section 6(6) and 10(2) of the 1986 Act.
70. Section 6(6) provides that, if a veterinary surgeon or person responsible for the care of protected animals is concerned about an animal's health or welfare, they have to notify the personal licence holder or, if this is not practical, take steps to ensure that the animal is cared for and, if necessary, humanely killed. By section 10(2) a personal licence has to include a condition requiring the licence holder to take precautions to prevent or reduce to the minimum consistent with the purposes of the authorised procedures any pain, distress or discomfort to the animal; and an "inviolable termination condition" specifying circumstances in which a protected animal must be killed humanely.
71. Put shortly, the claimants' case was that the licence holders were not shown to have given the animals adequate care overnight and the Chief Inspector therefore reached a wrong and perverse conclusion that the arrangements for caring for the animals were adequate. The judge put it thus:

"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."

72. This ground of claim as originally formulated was against the Secretary of State alone. An equivalent claim against the Chief Inspector was introduced by amendment permitted by the judge shortly before the hearing. By Respondents' Notice to the cross-appeal, the Secretary of State sought to contend that the judge was wrong to allow the amendment. Mr Giffin acknowledged at the hearing before us that, on the way in which the appeal was put before this court, the Secretary of State had not been prejudiced by the very late amendment. Mr Giffin accordingly did not pursue the contention that permission to amend should not have been given.
73. The judge dealt with this ground for judicial review as follows in paragraphs 49 and 50 of his judgment:

"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."

74. The claimants' grounds of appeal are that the judge was wrong to conclude that the Chief Inspector was entitled to accept claims made by licensees during his investigation that appropriate but unrecorded out of hours monitoring of marmosets did occur sufficient to make up the lack of documentary evidence of such monitoring. The assertions were uncorroborated and unparticularised and made long after the event. It is further said that the evidence before the court did not bear out the Chief Inspector's claim that there was no inconsistency between the unrecorded claims of overnight monitoring and the subsequent day time records. This was an inherently unreliable way of finding out what had happened in the intervening period. It is further said that the judge was wrong in failing to hold that the Chief Inspector should have concluded that unnecessary suffering may have been experienced by certain marmosets under project licence PPL80/1344 in the face of uncontradicted evidence. Accordingly the judge was wrong to hold that the Chief Inspector was entitled to conclude that overnight care arrangements were generally adequate within the statutory framework.
75. In my view, these essentially factual questions are at the very fringe of what is appropriate for a court to consider on a judicial review application. The written submissions in support of this ground of appeal contain many pages of dense factual material about individual marmosets, which the judge rightly did not pronounce upon in detail, and which certainly should not be the subject of detailed inexpert analysis in this court when no important point of law is raised nor any factual matter of enduring relevance. The Chief Inspector considered all this material, except in so far as it may have emanated from the claimants alone and had not been disclosed to the Chief Inspector at the time.
76. The claimants' case is that proper care of the animals overnight and proper record keeping are necessary for the licence holders to comply with the condition of their licences and for inspectors properly to be able to undertake their statutory inspection functions. That is uncontroversial. The case then is that the information available to the Chief Inspector was not adequate. It is accepted that full written records were not kept overnight. The evidence was that there was unrecorded out of hour's attendance with such records as there were comprising largely positive reporting only. I understand that a positive report is one which has something of substance to say, in contrast for example with the common form General Practitioner's note "NAD"; which records only the occasion of the examination and the fact that nothing abnormal was discovered. The case is that the Chief Inspector was irrational to accept that partial records of this kind were adequate, when they did not enable him to perform his own statutory function properly.
77. The claimants complain that the Chief Inspector claimed to have seen documents not available to the court, but failed to produce such documents at the hearing. The judge noted this in his judgment. The claimants say that on the documents which were available, the care arrangements were accepted to have been inadequate. The claimants then say that, even if claims of unrecorded overnight monitoring were acceptable, they did not establish that adequate overnight monitoring occurred in the face of particular case studies, to which the claimants refer, for which the Chief Inspector does not assert that unrecorded monitoring filled the gaps in the records. Mr Drabble submitted that it was not open to Dr Richmond to find that the monitoring was adequate on the information he said he was given and in the light of what was known to have happened to individual animals.
78. The Secretary of State's case in brief is as follows. The Chief Inspector saw all the relevant documents when he visited the Cambridge establishment. The post-operative sheets were only part of what he saw. He observed the care given at the establishment, interviewed staff and conducted his own investigations. His evidence of what he observed and heard is as valid as any other evidence. Upon the evidence which he relied on as a whole, he was entitled to conclude that the care was adequate. It was not his task to comment on any of the 16 specific cases referred to by the claimants. He looked at care standards for many hundreds of animals. In principle, minor mistakes of fact do not vitiate his general conclusion.
79. As to the record keeping, the Chief Inspector stated that the absence of records overnight and positive reporting only were not best practice. He concluded however that the record keeping as a whole was adequate and did not compromise animal welfare. Neither the statute nor the Guidance prescribe record keeping in any particular form relevant to this enquiry. The Secretary of State submits that the Chief Inspector was entitled to accept what he was told that there was a system of positive reporting, and that it is hopeless for the claimants to argue otherwise. There was a clear rationale for that system to which the Chief Inspector referred in evidence. The Chief Inspector was entitled to conclude from all the information available to him that the animals were properly cared for.
80. The proposition that the Chief Inspector was not reasonably entitled to accept as true what he was told is not, I think, pursued. The judge was certainly not obliged to reject the fact that the Chief Inspector had seen more documents than the post-operative sheets. Positive reporting only at night may not have been best practice, but the main question was whether the animals were in fact properly cared for. It was, I think, properly open to the Chief Inspector to conclude in general that they were, despite the absence of full records, upon his acceptance that unrecorded monitoring did occur (which is not, I think, intrinsically unlikely) and that positive reports were made if there was something positive to report. Further a process which checked day time records for consistency was capable of contributing to the overall judgement. The general conclusion that care was adequate is not vitiated by reference to a relatively small number of individual animals, not all of whom featured in the Review because material available only to the claimants was not then available to the Chief Inspector. In my view, the judge was entitled to conclude that a small number of errors or omissions did not vitiate the conclusion. This is especially so when a main plank of the claimants' case is a criticism of the adequacy of the evidence of the Chief Inspector himself or of the evidential material which he said he had seen or heard.
81. I would dismiss the cross-appeal and reiterate that its subject matter is at the further boundary of that which is suitable for judicial review.

Dyson LJ:

82. I agree that the Secretary of State's appeal should be allowed and the Respondents' cross-appeal dismissed for the reasons given by May LJ.

Moses LJ:

83. I also agree.