England and Wales High Court (Administrative Court) Decisions

IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
ADMINISTRATIVE COURT

		Royal Courts of Justice Strand, London, WC2A 2LL
		14/12/2015

Mrs Justice Andrews:

1. The Defendant ("the Secretary of State") is responsible for the licensing and regulation of animal experimentation under the Animals (Scientific Procedures) Act 1986 ("the 1986 Act"). That statute was amended with effect from 1 January 2013 to give effect to Directive 2010/63/EU on the protection of animals used for scientific purposes.
2. The 1986 Act regulates experimental or other scientific procedures applied to various living creatures including mammals, where the procedure may have the effect of causing the animal pain, suffering, distress or lasting harm. Carrying out research which requires a licence without obtaining one is a criminal offence. The general scheme of the 1986 Act is more particularly described in the judgment of May LJ in the case of Secretary of State for the Home Department v R on the application of Campaign to End All Animal Experiments (trading as the BUAV) [2008] EWCA Civ 417 at [3]-[12]. I shall refer to that case hereafter as "SSHD v BUAV".
3. The statute makes provision for three forms of licence: establishment licences, personal licences and project licences. As scientific experimentation on animals is a highly controversial subject which arouses strong feelings, and has been known to provoke violence against the scientists concerned, the identity of those to whom such licences have been granted is not published.
4. The Secretary of State has the power to impose conditions on licences under s.10 and Schedule 2C of the 1986 Act, but breach of a condition does not, in and of itself, invalidate the licence. A wide range of sanctions for breach of a licence condition (or a provision of the statute itself) is set out in s.11. The Secretary of State has power under s.11(2) to issue a Compliance Notice ("CN"), which specifies the condition or provision that the Secretary of State considers the holder is failing or has failed to comply with, specifies the action to be taken to ensure the failure is not continued or repeated, and any action to be taken to eliminate or reduce the consequences of the failure, and sets a time limit for compliance. The CN must also explain the effect of s.11(3) which provides that if a CN has been issued and it appears to the Secretary of State that the holder of the licence has failed to comply with it, the Secretary of State may revoke the licence (unless the notice has been withdrawn or varied and the holder is in compliance with the notice as varied.)
5. The Secretary of State exercises her regulatory functions under the 1986 Act through the Animals in Science Regulation Unit ("ASRU") which is part of the Home Office. The Head of Unit is Dr Judy MacArthur Clark, who made a witness statement describing the structure and work of ASRU. She explained that under the Carltona principle, licensing decisions are taken on behalf of the Secretary of State by licensing officers in the ASRU licensing team in consultation with an inspector appointed under s.18 of the 1986 Act, as required by s.9.
6. S.11(4) makes provision for the Secretary of State to take remedial action to safeguard the welfare of protected animals if the licence holder is unable or unwilling to take such action. S.11(5) contains the power to suspend, revoke or vary the licence if the Secretary of State does not take steps under subsections (2) or (4). A licence may be suspended for a specified period or until further notice.
7. S.18 requires the Secretary of State to appoint qualified medical or veterinary inspectors for the purposes of the 1986 Act. Dr MacArthur Clark is supported in her work by, among others, the Chief Inspector and 21 inspectors appointed under that section.
8. The duties of the inspectors are set out in s.18(2) of the 1986 Act, and in s.18 (2A) to 2(E), which were introduced with effect from 1 January 2013 to implement the requirements of the Directive. Those provisions provide, so far as may be relevant, as follows:

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

a. to advise the Secretary of State on applications for [licences under this Act] … on requests for their variation or revocation and on their periodical review;

b. to comply with any direction given by the Secretary of State under subsection (2A).

(2A) The Secretary of State may give a direction to an inspector which –

a. specifies the holder of a licence under this Act;

b. requires the inspector to visit the place specified in the licence, or in the case of a personal licence such places as the inspector considers appropriate, for the purpose of determining whether the holder is complying with the provisions of this Act and the conditions of the licence;

c. requires the inspector to provide a report to the Secretary of State on the holder's compliance with those provisions and conditions; and

d. in a case where the inspector considers that the holder has failed or is failing to comply with any of those provisions or conditions, requires the inspector to include within the report advice as to the action to be taken by the Secretary of State.

(2B) A direction under subsection (2A) may require visits carried out in pursuance of the direction to be carried out without notice to the holder of the licence concerned.

(2C) In determining the frequency with which a direction under subsection (2A) should be given in respect of the holder of a licence, the Secretary of State must take into account -

(a) the record of the holder in complying with the provisions of this Act and the conditions of the licence;

(b) any information suggesting that the holder has failed or is failing to comply with any of those provisions or conditions; and

(c) in the case of a holder of a section 2C licence –

(i) the number and species of protected animals kept at the place specified in the licence, and

(ii) the number and the type of regulated procedures, if any, carried out at that place.

(2D) The Secretary of State must seek to ensure that during the course of any year –

a. a direction is given under subsection (2A) in respect of one third of the persons who hold section 2C licences that authorise the carrying on of an undertaking involving the application of regulated procedures to protected animals;

b. a direction is given under subsection (2A) in respect of each person who holds a section 2C licence and keeps non-human primates at the place specified in the licence.

(2E) Any report provided to the Secretary of State by virtue of subsection (2A)(c) must be kept for a period of at least five years."

9. Dr MacArthur Clark explained that all licensed establishments are subject to regular scrutiny by inspectors, pursuing a programme of inspections which is agreed annually with the responsible Minister (on behalf of the Secretary of State) under s.18(2A) of the 1986 Act. Non-compliances are investigated by inspectors who provide advice as to what action should be taken (as required by s.18). Action is usually taken on behalf of the Secretary of State by senior licensing managers, but cases are sometimes referred upwards to the Head of Unit. Very occasionally, for example in particularly severe or contentious cases, the Head of Unit will refer the case to the Minister. This would normally take place at the conclusion of the investigation when the proposed sanctions have been determined, and the Minister is invited to accept the recommendation of sanctions.
10. By s.21 of the 1986 Act, the Secretary of State is required to publish guidance with respect to the manner in which she proposes to exercise her power to grant licences, and the conditions she proposes to include in such licences ("the Guidance"). By 21(5) the Guidance must be laid before Parliament. The current revised Guidance was published in March 2014, but this claim was based on earlier non-statutory guidance contained in Appendix 1 to the ASRU 2013 Annual Report. This set out categories of non-compliance with licence conditions which range in gravity from Category A, the lowest grade, to Category D, the most serious, which would typically result in a referral to the Crown Prosecution Service.
11. Category B non-compliance is defined as including some or all of the following characteristics:

•    Some animal welfare implications but not involving significant avoidable or unnecessary pain, suffering, distress or lasting harm;

•    No evidence of intent to subvert the controls of [the 1986 Act];

•    Not resolved within days of discovery, and further action may be needed;

•    Not sufficiently serious for revocation of the licences to be considered.

The "typical" sanction indicated in the Guidance for a category B infringement is a written reprimand, but the guidance states that ASRU is likely to require further appropriate action, such as additional training or altered management practices.

12. Category C non-compliance is defined as including some or all of the following characteristics:

•    Serious animal welfare implications involving significant avoidable or unnecessary pain, suffering, distress or lasting harm;

•    Evidence of untruthfulness or attempts to evade responsibility;

•    Future compliance concerns and further action required;

•    Not sufficiently serious for referral for prosecution to be merited.

The typical sanction indicated is the amendment, revocation or suspension of the licence. Again the non-statutory guidance states that ASRU will normally require further appropriate action, such as additional training or altered management practices.

13. The Claimant ("CFI"), formerly known as the British Union for the Abolition of Vivisection or BUAV, is a campaigning, advisory and educational organisation. One of its objects is to ensure that the legal protection afforded to animals used in scientific experiments is properly observed by those to whom licences have been issued. In April 2013 CFI provided ASRU with a detailed report of an undercover investigation it had carried out into the manner in which such experiments had been carried out at the Interested Party ("ICL") both under the auspices of an establishment licence and project or personal licences.
14. ICL notified ASRU that they had invited Professor Steve Brown to lead an independent investigation into the matter. Dr MacArthur Clark agreed with the Chief Inspector that she would instruct the Head of Compliance at ASRU (who is also an inspector) and the inspector who had recently been assigned to ICL ("the AI") to commence an investigation into all the allegations. The AI was a different individual from the inspector who had been assigned to ICL at the time of CFI's undercover investigations. The team was administratively supported by the Senior Compliance Manager, who is part of the ASRU licensing team. An immediate review determined that there were no identified reasons for immediate suspension of licences or referral for prosecution.
15. Dr MacArthur Clark explained how the detailed review of the available material, comprising the CFI's report and a video of material recorded during the course of the undercover investigation which the CFI had published on its website, plus initial interviews with Licensees and other duty holders at ICL, led to ASRU drafting a list of 21 potential cases of non-compliance for a preliminary report. Subsequently it was determined that there was only sufficient evidence to formally investigate 18 of these cases. A team of inspectors conducted those investigations. The investigations were thorough and extensive. The responsible Minister (Lord Taylor, followed by the Rt Hon Norman Baker MP) was kept informed about the progress of the investigations, but was not otherwise involved.
16. As a result of the formal investigations, by late June 2013 the inspectors determined that in five cases there were breaches of the licences, although only four of these related to the substantive allegations made by CFI. In the remaining case the inspectors concluded that there was insufficient evidence to substantiate the allegations made in CFI's material, but this was partly due to a failure by the licensees concerned to keep adequately detailed records. The inspectors therefore recommended that the individuals involved should be sanctioned for poor record keeping. Another of the original five cases was later reconsidered on the basis of additional evidence, and determined not to be substantiated. However a sixth case, (referred to as "Case 1") which had initially appeared to be unsubstantiated, was subsequently found to be substantiated on the basis of further evidence, thus restoring the number of substantiated cases to five.
17. By 3 December 2013 all but one of the investigations – the re-evaluation of Case 1 - had been completed. Dr MacArthur Clark met the Senior Compliance Manager and the AI on that date to discuss the investigations by the inspectors and their recommendations for sanctions. In addition to the sanctions recommended for the individual personal and project licence holders, the inspectors also concluded that the Establishment Licence Holder ("ELH") had breached his licence conditions in a number of ways and recommended that a Compliance Notice be issued requiring him to take corrective action. Dr MacArthur Clark agreed with that recommendation.
18. Following that meeting, a draft CN was prepared which included brief details of the four specific cases of non-compliance and briefly described the fifth case which had not yet been concluded. A briefing note was prepared for the Minister. The "Recommendation" to the Minister in that note was:

"a) That you note the progress of investigations, particularly the finding against [the ELH];

b) That you agree the draft Compliance Notice which ASRU proposes to issue to [the ELH]."

Thus, on the face of it, the sanction that the Minister was being asked to agree was the issue of the CN against the ELH. The briefing note went on to describe what had been done in the course of the investigations, and to summarise the results. The Minister was told that a preliminary report of the investigation was provided to his predecessor on 26 July 2013. It was explained that one case was subject to further investigation and that ASRU's final report, covering all cases, would be ready early in the New Year. A summary of all five cases, with sanctions where determined, was annexed, together with the draft CN. The draft CN summarised the four cases of non-compliance that the inspectorate had by then identified and concluded, and the fifth case that was still under investigation (Case 1). The Minister was told that ASRU intended to send letters to six individuals where non-compliance sanctions had been determined. However he was not provided with drafts of the letters.

19. The timing was stated to be "urgent". The explanation given to the Minister was as follows:

"Sending the Compliance Notice by 5 December will be in advance of us having sight of the independent report commissioned by [ICL] and chaired by Professor Steve Brown of MRC Harwell. This will avoid any perception that the Home Office may have been influenced by Prof. Brown's report. We expect to receive a pre-publication copy of the Brown Report on 5 December and we understand it is due to be published on 10 December 2013."

20. The Minister was told in the briefing note that his predecessor had committed to referring both the Brown Report and the ASRU Investigation Report to the independent advisory committee constituted under s.19 of the 1986 Act, the Animals In Science Committee ("ASC"). Since the ASRU Report could not be published until after the time had elapsed for any individual to appeal against the sanctions imposed on them, ASRU proposed to provide a confidential interim report to the ASC, together with the Brown Report, to enable them to commence their consideration as soon as possible.
21. According to Dr MacArthur Clark, the Minister agreed to all the sanctions recommended without change, and the Compliance Notice and letters were duly sent out to the individuals concerned by the Head of Compliance on 4 December 2013. The outstanding case was concluded on 9 December. The inspectors made adverse findings and recommended individual sanctions. Dr MacArthur Clark, on behalf of the Secretary of State, agreed the letters to be sent to the two individuals concerned, and they were sent out on 16 December 2013.
22. On 19 December 2013 the Chief Inspector provided a draft report to the Minister summarising the investigations, the recommendations made and sanctions applied; it was forwarded in confidence to the Chair of the ASC on 23 December, together with an executive summary of its findings and conclusions. The final report, including the Compliance Notice as an annex, was provided to the ASC after all possible periods of appeal had been exhausted, in advance of the ASC's meeting on 20 January 2014. The ASC delivered their report to the Minister on 2 July 2014. Shortly thereafter the ELH stepped down from holding that responsibility with immediate effect. The ASC report, suitably redacted to protect the identities of the individuals concerned, was published on the Gov UK website on 2 October 2014.
23. Although its investigation led to the ELH being strongly criticized and eventually stepping down, CFI is of the view that the sanctions imposed were too lenient and that the matter should have led to licences being suspended or revoked. As the Court of Appeal made it clear in SSHD v BUAV, decisions of this nature taken by an expert public body under statutory authority are not easily susceptible to judicial review. Nevertheless CFI managed to obtain permission to claim judicial review of the legality of the Secretary of State's decision making.
24. Permission was initially sought and granted on four grounds; however, at the onset of the hearing Ms Leventhal, on behalf of CFI, informed the Court that it would not be pursuing Ground 4. In the course of the hearing, with a degree of judicial encouragement, the parties reached a compromise on Ground 3, a completely discrete ground which concerned what CFI claimed to be a mistake (or at the very least an ambiguous statement) appearing on the face of the published ASC report. Without admitting any legal liability or conceding that the matter was properly the subject of a claim for judicial review, the Secretary of State has sensibly agreed to amend the report in a manner which both parties agree is sufficient to assuage the concerns of CFI.
25. That leaves Grounds 1 and 2; however, Ms Leventhal sought the Court's permission to amend her claim to raise a second limb of Ground 1. Before turning to consider the merits of the rival legal arguments, it is worth noting that it soon became apparent that this challenge was specifically directed towards the sanctions imposed in respect of only two of the five cases where infringements of the licence conditions were established, Case 1 and Case 5. As indicated earlier, Case 1 was the matter for which the results of the inspection were still awaited on 3 December 2013.
26. Case 1 was a case involving six mice that were shaved and had epilation cream applied to remove their black hair prior to imaging. Three of the mice were killed immediately after imaging, as part of the study design, and in accordance with the statutory provisions; the remaining three were found in a distressed state, shaking, unresponsive and had skin lesions. This was captured on the CFI video. The initial investigation of a potential Category C infringement led to a recommendation by the inspector that it should not be progressed as a formal infringement because the skin lesions observed on the mice appeared to have been the result of the animals fighting each other, rather than the incorrect application of the epilation cream or poor shaving. However, on review with the Chief Inspector and Head of Compliance it was agreed to seek additional advice from within the inspectorate of someone with professional experience as a veterinary dermatologist.
27. The dermatologist, having viewed the video, expressed the view that the clinical appearance of the animals was consistent with chemically induced irritant dermatitis, and that it seemed unlikely that the adverse clinical signs had only occurred on the day of filming. Although the inspector recommended obtaining a second opinion, Dr MacArthur Clark disagreed, and recommended that conclusions be drawn on the basis of the dermatologist's report. The conclusion reached was that there had been breaches of five licence conditions, and it was recommended that the matter be recorded as a Category B infringement and that letters of admonition be sent to the relevant licence holders.
28. Case 5 involved a single case study where slightly younger and lighter mice than usual were used and 31 out of 56 mice either died suddenly (14) or had to be culled due to reaching recognised endpoints under the Guidance (17). It was initially investigated as a potential Category C infringement. However the preliminary report stated that there was no evidence of animal suffering – the animals were monitored regularly and died suddenly.
29. After further investigation, the ASRU inspector reported that the incident appeared to have occurred due to a genuine misunderstanding by the licence holder. The inspector did not consider there was any malicious intent to circumvent the regulations; the animals were monitored regularly and the regulated procedures techniques appeared to have been performed competently. However there appeared to have been ineffective precautions to prevent or reduce to the minimum level consistent with the aims of the procedure any pain, suffering, distress or discomfort caused to the animals, since there was an issue as to whether the study was terminated early enough. There were also clear deficiencies with the way in which the work was conducted, particularly the questionable weighing and recording body weight regimen. The recommendation was that this be recorded as a Category B infringement and to send a letter of admonition to the individuals concerned.
30. Ms Leventhal submitted that the case was not about asking the Court to make scientific judgments or to step into the shoes of the ASRU Inspectors. It was a challenge to the legality of the way in which the decision-making process was undertaken and to the rationality of the decisions to record Category B infringements, and impose Category B sanctions, in two instances which on the face of it appeared to fall within Category C. She submitted that there were no, or no sufficient reasons to explain why the Inspectors recommended, and it was decided, to sanction the breaches as Category B infringements. Although these were the only two specific challenges of substance, there was a legitimate public interest in seeing to it that the statutory scheme and the published policy in the Guidance was properly adhered to by the regulator, and thus this was an appropriate case for the granting of declaratory relief.

Ground 1

31. In its initial manifestation, Ground 1 was a challenge to the legality of the decision taken to issue the Compliance Notice and sanction the individuals concerned, on the basis that it was ultra vires. It was contended that on a true analysis of the statutory scheme, once a report had been commissioned from the inspectors under s.18(2A) neither the Minister nor someone acting under delegated authority could lawfully take such a decision until the report had been obtained.
32. On behalf of the Secretary of State, Mr Greatorex submitted that Ground 1 was based on the fundamental misconception that the ASRU report was commissioned by the Secretary of State or the Minister under s.18(2A). In fact, this was an ordinary investigation by ASRU into allegations of breaches of licence conditions, and consequential enforcement carried out under s.18(2), which is the section under which reported instances of non-compliance would be investigated. He submitted that this was Dr MacArthur Clark's evidence, and that all relevant decisions were being taken by the civil servants, not the Minister. The reference eventually made to the Minister was in accordance with the inspectors' duty under s.18(2) to advise the Secretary of State on the review of a licence. In practice, the procedure under s.18(2A) was not used in circumstances such as these; that regime was all about the programme of statutory inspections agreed annually with the Minister described in Dr MacArthur Clark's witness statement.
33. It seems to me that in point of fact, Mr Greatorex is right. The evidence of Dr MacArthur Clark points strongly towards the conclusion that this investigation was carried out pursuant to the general powers of the inspectors under s.18(2) and not in consequence of any direction made by the Secretary of State or the Minister under s.18(2A), though at the end of the day it makes no difference to my decision which of the routes was actually taken.
34. The evidence is that the decision to commence the investigation was taken by Dr MacArthur Clark in conjunction with the Chief Inspector. The Minister (and his predecessor) were kept informed, but had no direct involvement prior to the Minister being asked to approve the CN and note the findings of the inspectors on 3 December 2013. I consider that Dr MacArthur Clark was not taking a delegated decision to give a formal direction under s.18(2A) requiring inspections and a report to be provided under s.18(2A)(c). She was simply reaching a decision by agreement with the Chief Inspector that the CFI report, coupled with the video, warranted further consideration and, if there was enough evidence of licence infringement, detailed investigation. If that is so, the point based on construction of the 1986 Act is unarguable. There is nothing in s.18(2) that mandates waiting for a report before taking any action.
35. It is true that there is nothing on the face of s.18(2A) to preclude an inspection being directed by the Secretary of State or the Minister as a "one off" rather than as part of an agreed programme of inspections of licensees. However even if that had happened in this case, there is nothing in the 1986 Act either generally or in the amended s.18 that requires the Secretary of State or the Minister (or even a civil servant taking a decision under Carltona principles) to wait until after a report has been produced under s.18(2A)(c) before taking any decision about whether or not there have been breaches of licence conditions or a decision on sanctions.
36. It is true that s.18(2A)(d) requires the inspector to include within the report advice as to the action to be taken by the Secretary of State for any failure to comply with the licence provisions discovered on such an inspection. However there is nothing in that provision which either expressly or by necessary implication fetters the general powers conferred on the Secretary of State by s.11 of the 1986 Act.
37. Ms Leventhal submitted that as a matter of logic, common sense and on a natural reading of the provisions of s.18(2A), if a Minister had specifically commissioned a report for the purpose of finding out whether a licence holder was complying with the conditions of the licence, and receiving advice as to how to respond to any breaches, he or she must await the report before taking any steps against the licence holder, especially if, as in the present case, Parliament had been informed that there would be a report, and so had interested parties such as ICL and CFI. That would engender a legitimate expectation that the report would be taken into consideration. Why else trouble to obtain it?
38. However, in my judgment, that cannot be a correct interpretation of the statute. Whether or not a report has been expressly commissioned, the Minister, or ASRU, must have the unfettered power to act before it is finalised, for example, in a case of obvious non-compliance which requires immediate action. It also cannot have been Parliament's intention that the Minister's powers are hampered by having to wait for a report if he takes one course open to him under one subsection of s.18 of the 1986 Act, but entirely unfettered if he, or ASRU, takes the alternative route.
39. It may be that in most cases not requiring urgent action, it would be prudent for the decision maker to await the report before taking any steps against the licence holder, given that the function of the report is to provide the information which would justify taking such steps and the advice on what those steps should be. Waiting for the report would avoid the potential criticism that the decision was taken without reference to all material considerations. However, that is something quite different from elevating the status of the commissioned report to a mandatory material consideration without which no decision taken would be lawful – especially if a report produced under s.18(2) would not have that status. The question whether the decision maker had enough information to make a properly informed decision must depend on the facts of each case; and there may be cases in which the inspectors have produced sufficient information to enable the decision to be taken before their report has been put into final form. This case was one such.
40. In my judgment it would make no sense to require the Minister or relevant civil servant to wait in all cases until the formal report was finalised, if sufficient information had already been gathered and passed on to the decision maker to enable the decision to be taken, and there was a good reason to get on with making the decision and taking the necessary steps by way of sanction. I was not persuaded by Ms Leventhal's argument that the expectation of the imminent publication of Professor Brown's report, and the concern to avoid a perception that his report influenced ASRU's decision was insufficient justification for taking a decision in respect of the 4 cases where the investigations had already been concluded, and after proper discussion at the highest level, ASRU had decided what sanctions they wished to apply, without waiting for the report.
41. In any event it is obvious that the same decisions would have been taken if they had been taken after the ASRU report had been produced first and a proper executive summary of it provided to the Minister.
42. Ground 1, in its original formulation, which became Ground 1(a) in Ms Leventhal's skeleton argument, is therefore without substance even if the investigation had been carried out under s.18(2A), which it was not.
43. Perhaps in recognition of the difficulties in putting the claim on that basis, CFI sought permission to run the alternative argument (Ground 1(b), raised for the first time in Ms Levethal's skeleton argument) that in any event the Minister was not provided with sufficient material information to enable him lawfully to take the decision concerned.
44. Ms Leventhal relied upon the well-known proposition articulated in R (National Association of Health Stores and Another) v Department of Health [2005] EWCA Civ 154 that the knowledge of civil servants is not to be imputed to the Minister. She contended that the Minister was not provided with an adequate summary to enable him to ascertain whether the proposed sanctions were appropriate, and pointed to the greater detail that was subsequently provided in tabular form by ASRU to the ASC, as an annexure to its confidential report, with brief summaries of the experiments and the inspectors' conclusions in respect of each of the cases concerned.
45. Mr Greatorex submitted that permission should be refused not only because of the delay in raising the point, but because this alternative argument was again based on a factual misconception, namely, that the Minister took the decision as to what the sanctions should be. That decision, he contended, was taken by Dr MacArthur Clark, who was plainly fully informed. All that the Minister was asked to do, in the briefing note, was to note the outcome of the investigations and agree the draft CN, a copy of which was provided to him. The fact that the Minister may have thought he was being asked to agree to the recommendations on sanction as well, was irrelevant because he was not being asked to do that.
46. Although the terms of the briefing note are capable of that interpretation, the problem with that submission is Dr MacArthur Clark's evidence that "ministerial agreement to the proposed sanctions [plural] was sought as explained below" and that the Minister "agreed to all the sanctions recommended without change". Although the "explanation below" was that that following the meeting on 3 December 2013, the Senior Compliance Manager advised the Minister "by way of written submission of the investigations and sought his agreement to the draft CN attached to the submission," Dr MacArthur Clark had made it clear earlier in her statement that on the rare occasions when she, as Head of Unit, would refer the case to the Minister, she would do so at the conclusion of the investigation when the proposed sanctions have been determined and the Minister is invited to accept the recommendation of sanctions.
47. So, regardless of what the briefing note stated on its face, it appears that in accordance with the general practice when matters were referred to him by the Head of Unit, the Minister correctly understood that he was being asked to accept ASCU's recommendation of sanctions in relation to the four cases of established breaches of the licences, as well as the sending of the CN in terms of the draft (that being the sanction recommended for the ELH).
48. The fact that CFI had not put its case on this legal basis at the time when Dr MacArthur Clark's statement was prepared is no answer to this point. I am not prepared to accept that this is just a case of infelicitous drafting. In any event it makes no difference to the outcome of the legal challenge, which fails even if I were to assume that the Minister took any relevant decision.
49. The legal principle involved is not contentious. The question whether the Minister, personally, had sufficient relevant information upon which to decide whether to accept the recommendations of ASRU (assuming that this is what he was being asked to do in respect of all sanctions and not just the CN) turns on the factual evidence. The point of law is closely related to the argument on Ground 1 as originally formulated, and this alternative way of putting the case on that Ground appears to me to have caused no substantial prejudice to the Secretary of State. I am not persuaded by Mr Greatorex that the point would necessitate an adjournment for the purposes of putting in further evidence from the Secretary of State about what the Minister knew at the time. Dr MacArthur Clark's evidence is clear that this was the only involvement the Minister had in the decision making process. I consider that the fairest course would be to accede to the application for permission to amend and deal with the argument on its merits, such as they are.
50. It is important to bear in mind that whatever the Minister was being asked to decide, he was not being asked to decide whether there were breaches of the Licences and if so, into what category of infringement within the non-statutory Guidance the breaches fell. That decision had already been made by the expert scientists within ASRU whose task it was to take it. The Minister was only asked to note the progress of the investigations (which presumably includes the conclusions reached) and specifically to note the findings made against the ELH. Having duly noted those matters, he was being asked to approve ASRU's recommendations regarding the steps to be taken by way of sanction, certainly against the ELH and (on CFI's case) against the individual Licensees as well.
51. The question for this Court is therefore whether the Minister was equipped with all relevant information so as to enable him to take a properly and sufficiently informed decision to approve the sending of the CN in the form of the draft with which he was provided and, to the extent that he was being asked to do so, to agree to/approve the other sanctions determined by ASRU in respect of the individual licence holders. In my judgment he was.
52. The decision was not taken in a vacuum, without the benefit of proper input from the expert inspectors. As is apparent from the briefing note, the main reason why this matter was going to the Minster was to inform him about the proposed sanction directed towards the ELH and to obtain his agreement to the issue of a CN. The summary of the investigation and its outcome in the briefing note is a fair one. The Minister was given a clear and sufficient explanation of why the ELH was regarded as bearing much of the responsibility for what was described as "the poor culture of care at ICL" and why it was proposed to serve him with a CN requiring him to instigate an immediate short term response and a long term improvement in the culture of care. A draft of the CN was annexed. The Minister plainly had enough information to enable him to decide that it was appropriate to take that course.
53. As well as the draft CN which made mention of the 4 individual cases, and the nature of the infringements found by the inspectors, the Minister also had Annex B to the Briefing Note, which told him in each case (and in the fifth case) what the type of infringement was, which conditions of the licences were breached, and under which category in the Guidance the non-compliance was adjudged to have fallen. Under the heading "outcome" in Annex B, he was told what the recommended sanction was for each licence holder. In each case, the sanction recommended was in keeping with the category of infringement. There was no mismatch. He was also told what the likely recommendation was going to be in respect of Case 1, the investigation of which was still ongoing as at 3 December 2013. He did not need to see the text of the letters of sanction, though he could have asked to see them if he wished to. Had he seen them, he would have been no better informed for the purposes of taking any decision he was being asked to take.
54. The Minister was given information that was accurate, and indicated that the proposed sanctions matched the category of infringement as determined by his inspectors. He had enough material to decide whether or not to approve the recommendations in respect of the individual licence holders. If and insofar as he took a decision, that decision was lawful.
55. Ms Leventhal submitted that if the Minister had been sent something similar to Annex A to the draft report sent to the ASC, which was effectively an executive summary of the findings of the inspections in each of the cases where conditions of the licences were found to have been broken, he would have been able to ask the inspectors why it was that in two instances, Case 5 and Case 1, they were recommending that they be treated as Category B infringements and sanctioned as such, when it appeared that they fell within Category C.
56. However that was not a matter for the Minister, even as regards Case 5, which was the only one for which he was being asked to agree the recommended sanction. Dr MacArthur Clark made the decision on sanction regarding Case 1. The Minister's role, at most, was confined to deciding whether to give his approval to the recommendations for sanctions made by those who were best equipped to decide into which category the infringements fell, and whose role was to advise him on the appropriate response to take. He did not need to know why the inspectors had put the case into that category, or even what the experiments were, in order to decide whether a sanction that fell within the indicative range for that category of infringement was appropriate or to approve the course that was recommended to him by the inspectors and endorsed by the Head of Unit.
57. In any event I am satisfied that the decision would have been exactly the same even if the Minister had been provided with all the additional information that Ms Leventhal contended he should have been provided with. It is highly improbable that the Minister would have decided to question the expert knowledge and opinion of the ASRU officials, or their recommendations and it is fanciful to suppose that, having seen something akin to Annex A to the ASRU Report, he would have queried the category into which they chose to place the particular breaches (though, as I have said, that was not something that he was being required to decide or agree).
58. As regards Case 1, the evidence is clear that Dr MacArthur Clark took that decision herself under her delegated authority, and she had all the requisite information to enable her to do so.
59. For all the above reasons, the claim under the amended Ground 1(b) must fail.

Ground 2

60. That leaves Ground 2, which can be disposed of very swiftly. CFI's complaint is that Case 1 and Case 5, initially investigated as Category C infringements, were both eventually recommended by the inspectors to be treated as Category B infringements and were dealt with as such. There was no similar challenge to any of the other findings or recommendations, or to the decision to issue the CN in the terms in which it was issued to the ELH. Thus it is not alleged that there was any fundamental misdirection or error of law in the decision-making overall.
61. Ms Leventhal submitted that, at least in the absence of a sufficient explanation for the apparent change in categorisation, given the fact findings in the inspection reports, what she characterised as a decision not to follow the Guidance or to re-categorise the infringements, was irrational. This was because the moderate severity limit (for pain, suffering, distress, etc.) set out in the protocols appeared to have been breached, which meant that the animals must have suffered "substantially". In both cases, it was found that there had been a failure to adhere to the authorised endpoints, in breach of standard licence condition 6.
62. Ms Leventhal also submitted that the choice of sanctions in those cases was inappropriately and inexplicably lenient given the severity of identified harm, and plainly neither effective nor dissuasive as required by the Directive.
63. The issue of what is an appropriate sanction is often highly controversial, and reasonable people can hold very strong and opposing views about it. That is especially true in the present context. As regulator, the Secretary of State has a particularly difficult balance to strike between the rights of licence holders under the statutory scheme and the duties, rights and responsibilities that the same scheme imposes to protect the rights of animals, to minimise permitted suffering and to prevent unauthorised suffering. That is why the 1986 Act expressly provides for a specialist team of scientifically qualified inspectors to advise her and her Minister.
64. This is a classic example of decisions which the specialist team of inspectors and civil servants in ASRU are in a far better position to make than this Court. I have been unable to discern any public law error in them. The choice of category following completion of an investigation depends on a wide range of different factors and the presence of one of the factors in the list in the Guidance (which is non-statutory) will not necessarily result in the infringement being assessed as falling within that category – it is all a matter for the evaluation of the inspectors who have seen and considered the evidence and carried out the interviews. In these two cases, for example, the inspectors were satisfied that there was no intention to evade the requirements of the statute and that there was full co-operation with their investigations. I cannot conclude on the evidence before me that there has been any departure from the Guidance.
65. The reports in each case explain the conclusions reached. There was no public law obligation on the inspectors to give any further reasons for their categorisation of these infringements. Certainly they owed no duties in this regard to CFI, even though CFI was plainly interested in the outcome of the investigations and the ASRU report was going to be published. The preliminary categorisation of these infringements as potentially falling within category C was not binding on the inspectors, any more than the interim decision in respect of Case 1 that there was insufficient evidence of any infringement of the licence at all. I consider the allegation of irrationality to be wholly without substance.
66. The claim for judicial review therefore fails on this Ground also.