Cruelty Free International v Secretary of State for the Home Department

Cruelty Free International (CFI) is a campaigning organisation concerned with the elimination of experiments on animals. While endeavouring to bring about the outlawing of all such activity, it adopts a pragmatic approach looking for methods to reduce the number of animals used in experiments and the suffering they endure. In particular it seeks to ensure that animals are given the protection Parliament intended existing legislation to provide. Experimentation on animals where the procedure may cause pain, suffering, distress or lasting harm requires a Licence. The Secretary of State for the Home Department has the authority to issue Licences allowing safety testing of products on animals, including mammals. To proceed with such testing without such a Licence or outside terms, is a criminal offence. The relevant legislation is the Animals (Scientific Procedures) Act 1986 (ASPA) and regulation is carried out by the Animals in Science Regulation Unit (ASRU). The claimant seeks to hold the defendant to account as to the efficacy and integrity of the procedures adopted to ensure that any Licenced testing is lawfully regulated. The full structure of the statutory scheme was described by May L.J. in Secretary of State for the Home Department v on the application of Campaign to End All Animal Experiments (trading as the BUAV) [2008] EWCA Civ 417.

The parties agree long-standing government policy has been that the Defendant will not Licence the safety testing of cosmetic products on animals. This policy is reflected in the defendant’s “harm/benefit” guidance which governs the exercise of its licensing powers under section 5A ASPA and which states (2014 version), “Licences will not be granted for testing cosmetics, alcohol, tobacco products or offensive weapons.” The product under examination in this claim is botulinum toxin (BT). BT is a neurotoxin which blocks muscle contraction and is potentially lethal as it can paralyse muscles for breathing or the heart.

In very moderate doses BT has medical uses, both pharmaceutically and therapeutically. These can be categorised as ‘on label’ and ‘off label’ medical purposes. It is well known that cosmetic uses have also been discovered (in that context BT is colloquially known as ‘botox’). The Medicines and Healthcare Products Regulatory Agency (MHRA) has Licenced BT products for human injection for specific medicinal uses subject to a condition that before a batch is released to the market by a manufacturer it must undergo safety testing. Safety testing of this product is classified as a “severe” procedure because of the high level of suffering and harm caused thereby to animals. Although there is some evidence that one manufacturer has developed a safety test which does not involve animals, the majority of medicines containing BT produced in this country are tested on animals because the MHRA considers this to be necessary to ensure the safety of each batch. The MHRA does not regulate the use of cosmetics and it is also agreed that the European Cosmetics Regulation does not cover BT. As an injectable BT is classed as ‘prescription only medicine’ and so cosmetic uses also require prescription before administration.

The meaning of a phrase encountered during the proceedings, ‘off label cosmetic use’, is not currently agreed between the parties. The claimant asserts it means the administration of BT for a purely cosmetic purpose unconnected to any form of medical treatment for a physiological or psychological condition, such as in a beauty clinic. Testing of BT intended for such use should not be Licenced by the defendant because that would be inconsistent with the policy against animal testing of cosmetics. The defendant’s view is that an authorised medical professional may prescribe BT to be used in circumstances which the claimant would consider to be purely vanity or aesthetic, such as to treat the appearance of wrinkles, but which the professional concerned may consider necessary to treat therapeutically, a less than severe psychological condition. This would be described as an off label medical use and may be how BT is administered, under prescription, in a beauty clinic. The ultimate decision as to how a specific dose of BT is to be used will made by the medical professional who acquires access to it and is in a position to prescribe it. The defendant cannot know, whether any part of a batch of BT tested under Licence, will end up being used in the way described by the claimant as off label cosmetic use. At the heart of the difficulty is the fact that all BT is classified as medicine because it must be injected

This claim was initially conceived after a meeting between the parties at which CFI understood that the defendant’s policy had changed and no longer excluded the safety testing on animals of BT intended for cosmetic use. The claim has evolved and it is now agreed that the defendant’s policy remains as it was.

It is necessary to delve into the history. A previous claim by CFI issued in 2011 and resolved in 2012 concerned whether the defendant was required to take steps to enforce the terms of the ASPA Licence then held by an entity known to the claimant as Wickham Laboratories Ltd (Wickham). The defendant accepted in her Summary Grounds of Defence to that claim, that she had a duty to take reasonable steps to satisfy herself that batches of BT to be tested under Licence carried a marketing authorisation as a medicinal product and were to be used for medicinal purposes. However, what was appropriate (i.e. the reasonable steps) would depend on the particular circumstances in question. Subsequently, she has expressed her willingness to consider suggestions. Furthermore, how compliance was to be achieved was a matter for the defendant. She also accepted that in pursuance of her duty she would require Licence holders to obtain and record information on the intended use of BT that is to be tested under the Licence concerned. The company Wickham itself confirmed that tests on BT in its laboratories were carried out solely for medical purposes and, in accordance with the limitations in its Licence, no animal testing was done by it for cosmetic purposes.

In correspondence, the defendant has disclosed that the relevant Licence term has been, since April 2014 when Wickham’s ASPA Licence was renewed,

“To undertake testing procedures to ensure the safety, efficacy, stability and overall quality of botulinum toxins and associated proteins used for medicinal products in accordance to registered marketing authorisations held with national and international regulators and in accordance with Good Manufacturing Practice” (emphasis added)”

Following the disposal of the 2011 claim the parties engaged in extensive correspondence about how the defendant could enforce the limitations on the Licence. They also met (in June 2013) and members of CFI attended a workshop on s.24 ASPA and transparency. The head of ASRU wrote in a letter dated 5 February 2016,

“as you know, we are concerned if botox is being used in procedures which are purely cosmetic and for which there is no medical requirement. I would welcome discussion with you as to how we may reasonably take steps to engage in this issue in so far as it exists. We are especially interested in suggestions you may have of enforcement mechanisms…”

A meeting was held on 4 May 2016 to discuss options for enforcement. Events at that meeting led to the present proceedings.

The current claim for judicial review was filed on 2 August 2016 and issued on 15 August 2016. The relevant decision was said to be 23 April 2014 or 4 May 2016. According to the Claim Form the decision to be reviewed was said to be,

“The decision communicated to the claimant on 4 May 2016 that the defendant now considered that there was no bar on animals being used to test botox intended for off label cosmetic use. Alternatively, the grant by the defendant of a project Licence on 23 April 2014”

The Statement of Facts and Grounds for Judicial Review stated,

“…. without warning or explanation, at a meeting with the claimant on 4 May 2016 purportedly about enforcement, the defendant departed from its long-standing stance. The defendant’s view now appears to be that botox batches tested at Wickham for a cosmetic end use, so long as administered under prescription (which all botox must be, by law), would not be prohibited by the Licence. The “medicinal purposes” condition in the Licence would then have a very different meaning (every purpose thus being “medicinal” if “prescribed”), and the defendant’s enforcement role in relation to that condition would be reduced to nil, there being nothing material to enforce against.”

The claimant asserted that BT produced by a pharmaceutical company called Ipsen was safety tested at Wickham under a Licence granted by the defendant before being marketed under the names Dysport and Azzalure. At paragraph 14 of its Grounds, the claimant said,

“In the UK and elsewhere, Azzallure is marketed by Ipsen purely for cosmetic purposes; Dysport has some medical indications but is also extensively used for cosmetic purposes in the UK. In other words, the Botox products tested under the Licence at Wickham are routinely used in the UK and elsewhere for purely cosmetic purposes (e.g. in private beauty clinics for aesthetic reasons.)”

The claim was brought on three grounds: firstly, the defendant was now misinterpreting the meaning of what the claimant characterised as the “prohibition” included in the Licence (set out at paragraph 7 above) which prohibits testing where the end use is cosmetic, secondly if the Licence had been intended from 23 April 2014 to allow such testing (when previously it had not) then the defendant had failed to undertake the necessary harm/benefit test under section 5B (3)(d) of ASPA before renewing the Licence in those terms and thirdly, if the prohibition had never intended to prevent testing on animals where the end use was to be cosmetic the defendant had treated the claimant unfairly in letting the claimant expend considerable resources on the basis that it did.

The present claim is supported by evidence from Michelle Thew, the claimant’s Chief Executive and David Thomas, a solicitor and the claimant’s legal consultant. Ms Thew sets out the history of the claimant’s interaction with the Licenced animal testing carried out by Wickham and the series of judicial review applications the claimant has made concerning that laboratory. She states at paragraph 63,

“Until the meeting on 4 May 2016 at the Home Office, it was common ground (or so we thought) that Wickham could not test on animals batches of Botox intended for cosmetics rather than medicinal use….”

She describes as a ‘volte face’ what the claimant understands to be the defendant’s ‘new’ position which she says ignores the nature of much of the end use of BT as a cosmetic procedure. She describes the Home Office’s present submissions as “semantic sophistry.” She understands the defendant’s case to be that because all products containing BT are Licenced by MHRA as medicines, an ASRU Licence for safety testing on animals will allow that procedure to be carried out even though it is known at least some of the product will be used, in the end, for purely cosmetic purposes (my emphasis). Ms Thew observes that were this to be correct the defendant’s very public and consistent commitment to the prohibition on testing cosmetics on animals would have been significantly breached. Also, it was difficult to see what the requirement that the Licence holder obtain and record information about the intended use (to ensure it was consistent with the limits of the Licence, see paragraph 7 above), was aimed at.

The evidence provided by CFI includes a letter of 3 May 2011 responding to a pre-action protocol letter from BUAV, in which the then Parliamentary under Secretary of State at the Home Office agreed that the Licence then held by Wickham did not permit the use of animals to test batches of BT where the end use was off label cosmetic. Also, that the defendant had a general duty to monitor compliance with the terms of the Licence issued under ASPA and to deal with non-compliance where it occurred. She also said,

“The limitation in the Licence to medical products relates to the purposes for which the testing is to be carried out and does not impose an obligation of any kind upon the Secretary of State to monitor the end use of the products tested.”

Responding by letter dated 16 June 2011, David Thomas for BUAV observed that the Secretary of State

“…has a duty to satisfy himself that batches of Botox tested at Wickham are indeed used for medicinal purposes and not for other purposes. Otherwise, the limitation is meaningless.

The steps required of the Secretary of State to satisfy himself that a Licence limitation of this sort is complied with will vary depending on the circumstances. How he ensures compliance is primarily for him, subject to the usual public law safeguards. But he must ensure compliance.”

In a subsequent letter in October 2014 Mr Thomas wrote to Dr MacArthur Clark Head of ASRU suggesting that the defendant could ensure that the end use of BT tested on animals at Wickham was medicinal by requiring the Licencee to insist by contractual provision that only vials of BT intended for medical (whether physiological or psychological) purposes were sent to it for testing on animals, with a verifiable audit trail available to the defendant’s inspectors. In response Dr MacArthur Clark reassured Mr Thomas that ASRU’s position had not changed,

“The authorisations under ASPA permit the testing of BT only where it is intended to be used for medicinal purposes. To ensure compliance, we require written confirmation from the project Licence holder that each of the batches of BT that is tested under their project Licence is required by either: (a) a marketing authorisation as a medicine or healthcare product; or (b) by a clinical trial authorisation for intended medicinal product. Furthermore, we require this confirmation in relation to each of the territories into which a tested batch may be sold. A small amount of tested BT may also be used for research, development and improvement of a medicinal product.

It would be impossible for the Secretary of State to monitor the usage of every vial of BT which has been tested in animals. However, she is assured that the use for medicinal purposes requires the involvement of the medical professional in prescribing the BT in the majority, if not all, of the territories supplied. For example, in the UK, medical practice is governed by the General Medical Council and we welcomed the GMC guidance to doctors published in July 2012 which banned the prescribing of BT by phone, email, video link or fax and made it explicit that doctors must have face-to-face consultations with patients before prescribing BT.”

Mr Thomas repeated, by letter dated 18 December 2014 his suggestion that the defendant should impose Licence conditions to ensure, via an audit trail, that only BT intended for medicinal use was tested on animals although he conceded that precisely how this was accomplished was a matter for the Secretary of State, “as long as it is effective”.

On 9 February 2015 Dr MacArthur Clark wrote,

“I believe I have already answered all the points you have made in both your letters-of 23 October and 18 December. The secretary of state at the Home Office cannot accept responsibility for ‘off label prescribing’ of any medicine. Furthermore, we do not accept that the prescribing of Dysport and as Azzalure as you describe ‘includes purely cosmetic applications’. Both products are Licenced as prescription only medicines and there can be no doubt that botulinum toxin does not fall within the legal definition of a cosmetic.

Nevertheless, we do accept that the current mouse bioassay to test the safety of batches of botulinum toxin is a severe procedure and, as I described in my previous letter, we are actively promoting best practice through the 3Rs to eliminate this test as soon as possible and, in the meantime, to minimise the suffering of animals used in this test.”

The parties continued to correspond and in June 2015 Dr MacArthur Clark responded to Mr Thomas’ ‘contractual provision and audit trail proposal’ by stating the following propositions for discussion;

She welcomed the opportunity for the meeting to discuss those propositions as well as questions Mr Thomas had raised. She also observed, “some advances you are trying to achieve will be outside our regulatory control. They may be the responsibility of another government department or regulator such as GMC. In that event, we may be able to offer to liaise with them if you can provide evidence of bad practice.”

In December Mr Thomas provided Dr MacArthur Clark with advice obtained from counsel, Miss Leventhal. This advice has been provided to me and I see that counsel’s opinion considered steps that could reasonably be taken to establish the ‘intended’ use of the batches to be tested. Mr Thomas asked Dr MacArthur Clark to say if she agreed with Miss Leventhal’s conclusions. In her response on 5 February 2016 Dr Clark stated that ASRU had found counsel’s advice informative and disagreed with only a small number of points in it. However, there remained differences as to what steps the defendant may reasonably be expected to take to monitor the end use of the product tested under Licence. Dr MacArthur Clark invited the claimant to a meeting to discuss options for enforcement which may address the concerns they both shared and asked for suggestions the claimant may have of enforcement mechanisms which are “both reasonable and within our legal powers that you think might be effective.” She also referred to her understanding of the GMC’s guidelines to doctors concerning prescription of Licenced medicines which should usually be prescribed in accordance with the terms of their Licence. Dr MacArthur noted that medicines may be prescribed otherwise than in accordance with their licence based on a medical assessment.

In his response on 28 April 2016 Mr Thomas drew attention to the fact that the GMC provides other guidance to doctors which indicates that treatments (including prescription treatment) must serve the patient’s needs, which may be interpreted broadly. He concluded that, “there is a divergence in approached by the two regulators: the Home Office prohibits what the GMC permits. It follows that the Home Office cannot assume from an absence of regulatory action by the GMC that Dysport and Azzalure tested on animals at Wickham are not being used for off label cosmetics purposes, even where doctors are prescribing for UK clinics.”

Ms Thew argues in her statement that the General Medical Council’s current guidance may not prevent the prescribing of BT injections for purely cosmetic purposes although the evidence she provides of correspondence with the GMC (email from a Policy Assistant on 20 May 2016) states that the Council distinguishes between medical and psychological purposes and states that the focus of a doctor deciding whether to inject BT will be on the need, including “psychological factors and general well-being”, of the patient as assessed by the doctor.

Mr Thomas provided a statement dated 6 September 2016 in which he set out his recollection of the meeting between the claimant, represented by Dr Clark and other personnel at ASRU and lawyers, and the defendant on 4 May 2016. He agreed that the purpose of the meeting had been to continue “long-standing discussions about enforcement by the Secretary of State of the limitation in project Licences authorising the testing on animals of batches of Botox products”. His summary of the divergences between the parties is,

“I began the meeting by confirming where I understood there to be common ground between CFI and the Home Office with regard to enforcement of the limitation. I said that it was common ground that the Wickham Project Licence did not permit the testing on animals of Botox where the end use was off label cosmetics. Dr MacArthur Clark interrupted me and said that this was not agreed. To put it mildly, the CFI team was greatly surprised by this assertion, given what successive ministers and officials had told parliament, the court in the Botox enforcement judicial review and CFI in extensive correspondence and other discussions. It also destroyed the purpose of the meeting.

Dr MacArthur Clark said that, as they saw it, there were 3 categories of uses of Botox products (boxes as she described them): (I) on label uses, which were necessarily medicinal and therefore within the scope of the project Licence authorisation; (II) off label medicinal uses (again in scope); and (III) non-medicinal uses (out of scope). As Ms Thew explains in her witness statement, CFI agrees with the 3 categories. However, Dr MacArthur Clark went on to say that they regarded cosmetics use as falling into category (II), not category (III), where CFI had thought the Home Office placed it.

Dr MacArthur Clark said all that was necessary for animal testing to fall within scope was for there to be a medicines market authorisation in place. As Ms Thew explains in her statement, and as we explained in the meeting, that would mean that all batches of Botox could be tested on animals because there are market authorisations for all Botox products (because of their acknowledged utility to certain clinical conditions). There would be nothing on which the limitation could bite. I asked Dr MacArthur Clark what type of use, then, fell within category (III) stop she said she could not think of anything: it was empty. When asked what, therefore, was the purpose of the limitation, all she could suggest was that it might catch batches destined for illegal, backstreet operations.

Dr MacArthur Clark claimed that the position she was outlining was not new.

There followed some discussion about how the harm: benefit test required by ASPA could be met based on the Home Office’s claim that the Wickham Licence permitted the causing of severe suffering to tens of thousands of animals every year for cosmetics purposes.”

Mr Thomas also dealt with the part of the discussion concerning the GMC,

“The Home Office team suggested that CFI direct its attention to the General Medical Council as the regulator of doctors: it should seek to persuade it not to allow doctors to prescribe Botox products tested on animals for cosmetics use. The Home Office would be willing to broker discussions. CFI declined the offer. There was no prospect, we said of the GMC prohibiting doctors prescribing animal tested botox products for cosmetics use when the Home Office, which was the animal testing regulator, allowed animal testing for this purpose. Indeed, it was doubtful that the GMC would have the legal authority to do so. Any event, doctors were only one among a number of groups of medical practitioners permitted to prescribe botox, including for cosmetics use. It appeared that the Home Office was impermissibly seeking to pass responsibility for the issue to the GMC, to kick it into the long grass.”

The relief sought was

In her Summary Grounds of Defence attached to the Acknowledgement of Service the defendant dealt with the substantive grounds by asserting that all three were predicated on a misunderstanding of both the meeting of 4 May 2016 and the defendant’s consistent position. She confirmed that her policy was to prohibit the testing on animals of vanity products and cosmetics (as defined by the European Cosmetics Directive.) BT is not so defined. She denied that anything communicated at the 4 May 2016 meeting amounted to a change of position on her part. It was important to recognise that once BT had been batch tested and found to be safe it can be prescribed for an on label or off label medical condition or purpose. These can be physical or psychological. Accordingly, BT, tested under Licence on animals, can lawfully and properly be used to ‘cosmetic’ effect if prescribed in order to address a psychological condition. It is impossible for the defendant to know prospectively whether any of the BT batch tested on animals under Licence would end up being prescribed for an off label non-medical cosmetic use. Such prescription is within the domain of individual medical professionals and their regulatory body, the GMC. Although the defendant recognised she had a duty to take reasonable steps to satisfy herself that the BT to be tested under Licence is intended for medicinal purposes, the claimant had not identified any steps that should have been taken that were not taken.

The defendant’s notes of the meeting held on 4 May 2016 between ASRU (including the Chief Inspector and Head of ASRU Judy MacArthur Clark (JMC)) and the claimants (including David Thomas a solicitor (DT)) record the following,

“JMC opened - acknowledged the long-term shared interest in removing the Potency test, given its severity and the use of large numbers of animals. She also acknowledged the complexity of the issues to achieve that, the good work done by both sides that contributes to ’refining’ testing.

JMC concerned to prevent UK manufacturers from becoming inhibited, risking testing diverted overseas, and clear that ASRU as a regulator has limits on their controls, but clear that ASRU want to work with CFI to the potential for further refinements. Offered CFI a platform to discuss this common objective.

CFI declined to discuss possibilities for ‘refining’ in any detail. DT felt the purpose of the meeting was a single agenda item, the [Home Office]’s (lack of) enforcement of a ‘medicinal purposes’ limitation in the ASRU Licence granted to Wickham Laboratories.

CFI assert that ASRU have previously conceded that Wickham are ‘not Licenced to conduct any testing which might ultimately be for off label cosmetic use’. ASRU challenged that assertion, given the wording of the Licence limitation is about limiting the product to ‘medical/medicinal purposes’ (botox is a prescription only medicine), ASRU explain that the CFI definition of the limitation as ‘excluding cosmetic use’, was too narrow for them to enforce in practical terms.

CFI continue to assert their view that the purpose of the limitation has always been understood to exclude and prevent ‘cosmetic purposes’ - and there can be no other explanation for the limitation in the Licence. CFI contend ministers have answered questions in the house to that effect and content interpretation of the limitation is established government policy. CFI said that in disputing that assertion ASRU were presenting a change of government policy.

A lengthy debate attempted to categorise the potential applications of botulinum toxin (botox) into 3 potential groupings that fails to agree the scope of the limitation separating the 2^nd and 3^rd categories in any detail/specifics.

1.

On label – all Botox is for use on prescription, but this is legitimate as prescribed, for clear medical purpose

2.Off label – where a doctor can make a decision in the interest of their patient to use a medicinal product in for a purpose that is not stated on the marketing authorisation for that product – this includes the use of Botox for medical conditions such as control of facial spasms and also includes ‘cosmetic’ use

3.

Illegal use of Botox

CFI contend that ASRU has previously stated that ‘the use of Botox for aesthetic purposes is not within policy’ and therefore that the off label prescription of Botox for ‘cosmetic’ uses should fall into category 3. ASRU argued that separation of the off label prescription of Botox into medical vs ‘cosmetic’ purposes (i.e. division of the 2^nd category) would be very difficult to regulate, particularly as some use of botox for cosmetic purposes is to treat psychological distress. Furthermore, botox is not a cosmetic as defined under EU legislation. ASRU brought up the example of other medicinal products used for ‘cosmetic’ purposes, such as antibiotics being used to treat acne.

CFI pressed for ASRU to set the limit at what they call ‘pure vanity’ or ‘aesthetic use’. ASRU agreed the potential to discuss with GMC and relevant bodies whether a definition could be framed preventing doctors from using botox for ‘off label aesthetic’ use. ASRU offered to broker conversations with the relevant bodies, who regulate medical practice. CFI dismissed these as potential solutions, and declined to be involved….

…… Despite the uncertainty around the respective interpretations of the wording of the limitation, CFI remained clear to the end of the meeting that their concern is what they see as ‘the failure of the Home Office to enforce a limitation on the Wickham Licence”

Permissionand an extension of time until the date of issue on 13^th August 2016 (but no protective costs order) was granted by Edis J. on 4 November 2016 in these terms

In an amended Statement of Facts and Grounds for Judicial Review the claimant removed references to Wickham itself and amended the relief sought accordingly. In addition, the principal declaratory relief sought was amended to,

“A declaration that the relevant Licence does not permit testing on animals of Botox, where the end use of the toxin is off label cosmetics (i.e. where its administration is not to address a recognised psychological or physiological condition.)”

Paragraph 14 was amended (and became paragraph 17) as follows,

“In the UK and elsewhere, Azzalure is marketed by Ipsen purely for cosmetic purposes; Dysport has some medical indications but is also extensively used for cosmetic purposes in the UK. There is, therefore, to put it at its lowest, a risk the botox products tested under the Licence could be routinely used in the UK and elsewhere for purely cosmetic purposes (e.g. in private beauty clinics for aesthetic reasons) unless appropriate measures were taken to ensure that the relevant batches were only used for medicinal purposes. In fact, there is strong reason to believe, as discussed in the witness statements [of Michelle Thew and David Thomas] that this is precisely what happens.”

The defendant’s response to the amended grounds neatly crystallised the difficulty with the claimant’s position. She pointed out that her position was unchanged and the claim was brought on a misunderstanding. The defendant granted the relevant licence on the basis that it does not permit testing a batch of BT on animals where, prior to testing, it is clear to the Licence holder that the only end use of the batch is for non-medical vanity purposes. The claimant had moved from a positive assertion that BT products tested under the Licence in question were routinely used for purely cosmetic purposes to asserting a risk that this might happen. The reference in the new paragraph 17 to “appropriate measures” begged the question which the defendant has posed to the claimant and which remained unanswered, namely, what further measures would be appropriate to safeguard against the risk identified by the claimant. The altered declaration sought was unacceptable because it appeared to imply that the mere fact of end use of a BT product for non-medical vanity purposes would amount retrospectively to a breach of the Licence.

The defendant relies on a statement made on 28 January 2017 by the then current Chief Inspector and Head of ASRU, Dr Sue Houlton. She had been an inspector in ASRU for 28 years with national managerial responsibilities for 15 years. She explains that the unit seeks to minimise, over time, the number of animals used in scientific experiments and to reduce the suffering of those animals that are used. This is called the 3R’s principle: replacement, reduction and refinement. Part of the work of ASRU is to engage with stakeholders including animal-rights groups and the scientific community. In respect of laboratories in which BT is tested,

“ASRU regularly meets establishments that test batches of BT in finished products to keep abreast of scientific developments in this regard and to encourage them as far as possible. I will continue to press for alternative tests to be found and the testing on animals to be kept to a minimum. However, ASRU has no mechanism for knowing how much BT medicine is prescribed in the UK or where or for what purpose, or the proportion of this which has been tested on animals in the UK under a Licence issued by ASRU. The claimant has not provided such information and I doubt very much that it exists or could readily be obtained.”

She describes the way that ASRU monitors compliance with Licence conditions by Licence holders.

“In the meantime, and in accordance with the duty acknowledged in the 2011 claim referred to in the claimant’s grounds, every establishment in the UK which holds a project Licence authorising the safety testing on animals of batches of BT, is required by ASRU to obtain written confirmation from its customers that the BT tested is intended for use as a medicinal product. This is written into each relevant Licence. ASRU inspectors check this as part of their routine compliance monitoring function by requiring establishments to make these confirmatory letters available for inspection as proof that this Licence condition is being met. I do not believe there is anything more ASRU can do, within its finite powers and resources. The claimant has been invited to say what other steps it thinks ASRU should take but it has not suggested anything.” (emphasis added).

Efforts have been made to settle the claim including the exchange of terms of a potential declaration. It is not necessary to go into the back-and-forth contacts. I observe however, that what I shall call the “point of anticipation” issue has been one sticking point preventing agreement between the parties. To summarise, the claimant sought a settlement on the basis that an ASPA Licence of the type granted to Wickham prohibited testing BT on animals if it could be anticipated that the end use of any of the batch would be off label cosmetics because that would not be a medicinal purpose. The defendant’s response focused on the difficulty of understanding the significance of the word ‘anticipated’ in that formulation. The category of use the claimant wished to cover could only occur when and if a professional authorised to dispense prescription only medicine prescribed BT, which had been tested on animals under Licence, for a non-medical purpose. How was the defendant to anticipate, prior to testing, that such a future event might occur? If, as the claimant asserted, the use of BT was widespread for purely cosmetic purposes what evidence was there that any BT so used had been tested on animals under Licence in the United Kingdom?

As late as 13 July 2017 the conflict between the parties had reduced, according to a letter from the claimant to the defendant of that date, to two matters: firstly, whether in fact the defendant did require Licence holders to obtain and record information on intended use beyond simply confirming the marketing authorisation which is required for all BT irrespective of its end use and secondly, what the limits of the Licence to test were, for example if the Licence holder’s client intended only 1% of the batch to be tested to be used for medical purposes would that satisfy the assurance as to intended use requirement imposed following the 2011/12 judicial review proceedings? Mr Thomas’s letter went on to say,

“….. My client accepts that, with the best will in the world, there can be no guarantee that no BT tested on animals will ever end up being used for cosmetics or vanity purposes. The Licence holder’s duty is to ensure that, prior to testing, reasonable measures are in place to ensure that the BT he is asked to test on animals is not for such purposes, and your client has a concomitant duty.

As we have repeatedly said, enforcement is for your client, subject to the usual public law controls. However, this is subject to caveats. First, she must know what she is enforcing-in other words, what the scope of the limitation is. There remains a clear dispute between our clients about the proper construction of the limitations: that is for the court to resolve if the parties are unable to do so. second, the steps she takes must be capable as a matter of law of enforcing the limitation (see the point about marketing authorisations above).”

At the hearing I asked the claimant which decision was the subject of this claim. I was told that it was the statement at the 4 May 2016 meeting which the claimant considered to be a change in the defendant’s position. It became clear that although the defendant had re-stated her position the essence of the claim was her failure to act lawfully in accordance with it. The claimant distinguished between 2 types of information that the regulator could obtain from Licence holders: type A information such as the granting of Licences upon proper application with a structure of inspections to ensure such formalities as MHRA authorisations, and type B information namely requiring Licence holders to obtain and record details of the intended use of the BT to be tested. Counsel for the claimant argued that the 2011 application for judicial review was concluded on the basis that the defendant would absorb a requirement for both types of information into the regulatory structure.

However, in 2012 a sample letter from the defendant to a Licence holder obtained under a Freedom of Information request made no mention of category B information being required. The suggestion in Mr Thomas’ October 2014 letter of requiring the Licencee to insist, by contractual provision with the manufacturers, that only vials of BT intended for medical (whether physiological or psychological) purposes were sent to it for testing on animals, with a verifiable audit trail available to the defendant’s inspectors was, likewise, never taken up. Miss Leventhal for the claimant drew attention to the terms of the harm/benefit analysis carried out in April 2014, prior to Wickham’s Licence being renewed. This document headed “Assessment of Project Licence Application”, under ‘What benefits are expected from the project?’ required no category B information and after the description of the on label and off label medicinal use of the product including “the management of tics and hyperhidrosis, wrinkle lines where the severity of the lines have an important psychological impact on the patient, and migraine” the only reference to the end use of the product to be tested was,

“all sponsors that use REDACTED have undertaken to only send products which are made, tested and released under a marketing authorisation for medicinal products.”

Miss Leventhal submitted that evidently, the anticipated use of the BT to be tested was not something that the defendant required confirmation about. Although Dr Houlton’s witness statement refers to requiring information which would clearly fall into category B, the claimant has never seen an example of such a request to a Licence holder or its clients.

Mr Greatorex for the defendant drew attention to the lack of a reliable factual basis upon which the court could conclude that BT tested on animals in the United Kingdom is then being used to inject patients who have no medical need whether physical or psychological; this was a fundamental tracing problem which, he submitted, renders the claim academic. Secondly, in any event such use is virtually undiscoverable even after it has happened but entirely impossible to predict by a regulator in advance. The regulator did agree, following the 2011/12 judicial review proceedings, to write to a particular Licencee, Wickham, who had been the target of the claimant’s attention in the past to ensure that the defendant had absolute clarity about the intended medicinal use of BT being tested under the Licence. This was done by writing to the Licence holder, having discussions at regular enforcement visits and by contact with those companies (known as sponsors) who were known to the defendant to use the Licence holder. This latter initiative was evidenced in the passage from the April 2014 “Assessment of Project Licence Application” quoted above.

Furthermore, the correspondence in 2014 between the claimant and the defendant had focused on the intended use of the batches being tested under Licence. The best evidence of intended medical use was from those using the Licencee’s laboratory, namely the sponsors. And they had been required to undertake only to send products which were going to be released in accordance with the market authorisation. The defendant could do no more. The claimant has used the word ‘intended’ in correspondence and the only people able to say what the batches to be tested under Licence are intended for are those manufacturers or sponsors who are now required to do so.

Counsel for the defendant maintained that her position has been consistent since the previous judicial review claim and remains so. Furthermore, the court should be hesitant before intervening because, as Andrews J. observed in R (on the application of Cruelty Free International (formerly the BUAV) V SSHD and Imperial College London (Interested Party) [2015] EWHC (Admin) (para.63)“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.”

The defendant submitted that the claimant’s characterisation of this claim as targeted at the failure of the defendant to obtain type B information from Licence holders or sponsors was misconceived. The defendant has, since the previous application for judicial review in 2011/12:

The defendant remains ready to consider any further realistic concrete steps she can take. The offer to engage with the claimant and any regulatory medical authorities remains open.

In response Miss Levanthal said she was heartened to hear that an undertaking is obtained from sponsors that they will only submit for testing batches intended for use as a medicinal product although she pointed out that no example of such a sponsor/client undertaking had been provided. She accepted that the evidence of Dr Houlton confirmed the position to be as submitted by the defendant but her rhetorical question for the court was: “But how do we know?” She also observed that such a wide undertaking would not necessarily prevent some of the batch tested being used, ultimately, for cosmetic purposes but she did not suggest any specific further step which the defendant could reasonably take within the regulatory scheme.

At the end of the hearing I gave the defendant an opportunity to make good the evidential lacunae present in her case by providing evidence of sample undertakings sought and obtained as to the intended use of the batches to be tested at Licenced laboratories, as described in Dr Houlton’s statement. Accordingly, in a statement on 26July the current head of ASRU Mr Will Reynolds purported to echo Dr Sue Holton’s written evidence that written confirmation was obtained that BT tested under Licence was intended for use as a medicinal product. However, he did so in less than unambiguous terms,

“It is expressed in terms of the tested product being covered by a marketing authorisation as a medicinal product rather than in terms that refer to “the intended use” as such, but the reference to the product being covered by a marketing authorisation is considered by all relevant parties (i.e. ASRU, the Licence holder and the sponsors) to be synonymous with this. This is because so far as we (and they) are concerned, a product which is covered by a marketing authorisation as a medicinal product is intended for use as a medicinal product.

However, what is important to note is that, as also explain below, ASRU does not just rely upon the provision of these documents: the position and understanding of the Licence holder and sponsors is regularly checked by inspectors when inspecting the Licence holder and in discussions with the sponsors and further verbal confirmation sought as and when it appears necessary or appropriate. I am confident, from the written documentation and discussions with my colleagues (and in particular those most directly involved in inspecting the relevant Licence holder and any discussions with sponsors) that the intended use restriction is understood by all relevant parties.”

Mr Reynolds confirmed that 3 companies commission BT testing in the United Kingdom under the relevant Licence. The documentation accompanying the statement refers to a Licence holder, all 3 sponsors and internal documentation. All of it is heavily redacted.

Six pages of correspondence from the Licence holder between 2012 and 2014 has been provided. The first, dated 21 September 2012 sent to ASRU is plainly in response to correspondence from that body. The writer states “the content of this letter both formalises the email information sent to you on the 19 September 2012 and provides supplementary information required in the letter.” The first heading in the letter is ‘Marketing Authorisations’ and refers to a letter enclosed regarding medicinal licensing and territories for the BT product concerned. But then, under the heading, ‘Authorisation of Purposes’ the following appears,

“BT products tested under this Licence are marketed as a medicinal product in [redacted] territories, the letter enclosed confirms this. It is my understanding that [redacted] have disclosed to the Home Office that only products for these territories are sent to [redacted] with other testing being conducted in other EU states. In order to assist us in compliance with the requirements of the PPL could the Home Office confirm this undertaking?”

The 2^nd letter dated 17 September 2012 also refers to the product being “marketed as a medicinal product”. These references appear to indicate that ASRU required that the Licencee sought and obtained assurances as to the marketing of BT products beyond the existence of a marketing authorisation from the MRHA.

This impression is confirmed in the 3^rd document, an email of 7 January 2013 in which the writer refers to correspondence from ASRU of 19 November 2012 and states,

“… I have now received enough information to respond more fully. I address the points below as they are laid out in your letter.

1.

I believe the information supplied by [redacted] is sufficient to ensure we are testing medicinal products in all territories. Likewise, the attached letter from [redacted] gives enough information to assure me that the product will be used and marketed for medicinal purposes (emphasis added) when marketing authorisations are granted.

2.

[Refers to a name change of the BT product concerned]

3.

I have attached a letter from [redacted] related to their testing carried out at [redacted]. We test BT [redacted] for one other customer and I have not yet been successful in eliciting a response from them. This product is not frequently tested at [redacted] the last set of assays were October 2010 and no further testing will take place until these assurances are sought.

4.

You will see from the attached letter that [redacted] have agreed that any information on new MA’s will be forwarded to us and that only material for medicinal use (emphasis added)will be sent. I have asked [redacted] to ensure they are able to provide the same assurance for any new territories……”

Similarly, in the 4^th piece of correspondence, another email dated 21 February 2013 which is again concerned with the product Licence and states,

“further to our conversation on the 13 February you have asked for clarification on the testing we carry out on [redacted] BT. I asked the sponsor to provide me with information confirming the end use of their material (emphasis added), confirming as we have with others that it is a medicinal product on 17 December 2012. They replied on the 23 January 2013 but the declaration provided was not, in my opinion, clear enough so I requested further information. I have made it clear to this sponsor that we will not be able to carry out further testing until these assurances have been provided to [redacted] (emphasis added). I hope this update is sufficient.”

Another email dated 5 November 2014 with attached letters that have not been provided reads,

“attached is the original correspondence with [redacted] and scans of the letters from [3 redacted]. We will write again to these companies for updated confirmation on the medicinal use of the product (emphasis added) and any additional territories….”

Sponsor 1: two letters are provided one in January 2013 the 2^nd in November 2014. The 1^st concerns a new BT product in development in respect of which there were no marketing authorisations at that time but the sponsor states that all materials sent to be tested under Licence “will be to support medicinal product”. The 2^nd also refers to the BT product being in the registration process but no market authorisations having been granted and concludes that all materials sent to be tested “will be to support medicinal product applications.” Mr Reynolds accepts this correspondence is not strictly relevant to the current case because of the stage of development of the BT product concerned however he submits the correspondence demonstrates the appropriate assurances are being sought.

Sponsor 2: again, two letters are provided, one in September 2012 the other in November 2014. The first states “please see attached the list of territories with marketing authorisations for [redacted] marketed as a medicinal product” and the 2^nd states “in response to your email request for information from [redacted] to support a request made by the Home Office, please see attached updated list of territories with marketing authorisations for [redacted] marketed as a medicinal product.”

Sponsor 3: 2 letters are provided, one in April 2013 and the 2^nd in November 2014. Both letters again refer to market authorisations for the BT product currently Licenced as a medicinal product.

Internal ASRU documents include a visit report dated 18 July 2012 in which the key findings include reference to the 2011/12 judicial review in the following terms,

“BUAV JR -related issues: [redacted]. b/end-use of [BT] product…. There was reluctance to accept the proposed additional PPL conditions, compelling [redacted] to ensure that the MA’s of all territories in which BT products they test have a ‘medical’ indication. (emphasis added)”

In an internal email dated 25 February 2013 which appears to be from an inspector the writer states,

“2/ responses to[redacted] letters.

Although this has been a rather protracted process, we now have all the information required. [Redacted] apologised for sending information about only one of his customers [redacted]. He misinterpreted our letter and there was no attempt to obfuscate. We now have the necessary information for sponsor 2 and sponsor 1 (a subsidiary of[redacted]). A 3^rd sponsor (I don’t have their name) haven’t requested any testing since 2010.

[Redacted] has provided assurances that they will not test for them unless the sponsor provides the necessary confirmation about the end-use of the product (see attached email message) (emphasis added). For the [redacted] product, [redacted] has agreed to obtain assurances when the MAs for the product are granted, rather than annually as specified in their letter to him of 7 January. They have already provided general assurance that this product will only be for medicinal uses.”

The claimant’s written response to this evidence dated 13 September 2017 was that the material provided was insufficient to demonstrate that any Category B assurances were being obtained. Attention is drawn to Mr Reynolds’ view that a marketing authorisation is “synonymous” with intended use. The claimant points out that if this is correct, the defendant is doing no more than she was already doing prior to the 2011/12 judicial review application. The claimant suggests that Mr Reynolds’ evidence is confirmed in the correspondence attached to his witness statement, which, it is said, contains no reference to “intended” or “end” use and the word cosmetic does not appear anywhere. Miss Leventhal submits that neither Mr Reynolds nor the sponsors consider that anything other than a marketing authorisation is relevant or necessary. Nothing else is being sought and thereby the defendant is misinterpreting the relevant Licence condition, unlawfully failing to fulfil her enforcement duty and is ignoring evidence in the public domain summarised in the two statements from witnesses provided by the claimant that BT tested on animals in the UK is routinely used for cosmetic purposes.

The defendant has provided a short further response which it is unnecessary to set out.

The courts do not readily interfere with the work of regulators. In R v Licensing Authority Established under The Medicines Act 1968 ex p Smith Kline & French Laboratories (No.1) [1990] 1 AC 64 Lord Templeman said,

“The courts should be reluctant to criticise the practices of the licensing authority or to grant injunctions or orders or declarations against the licensing authority which is endeavouring reasonably and conscientiously to discharge the owner is duties imposed by Parliament and is acting in good faith.”

Animal experiments are controversial. For a variety of reasons they are carried out away from the public gaze. There is an important public interest, consistent with government policy, in ensuring that the suffering of animals at any, but certainly the most severe level, does not occur except where necessary under a rational and enforceable regulatory scheme. Consistent with the statutory scheme of regulation under ASPA if the Secretary of State imposes conditions on Licences then she has discretion as to what steps to take if a Licencee is in breach.

Significantly, the parties now agree that there has been no change in the defendant’s policy against allowing cosmetics to be tested on animals. The claimant does not suggest that the condition in the Licence set out at paragraph 7 above is inadequate.

Furthermore, this is not a case concerned with a failure by the defendant to invoke breach proceedings against a Licencee who has breached the terms of its Licence. This is a critical point. Although the claimant suggests there is unambiguous evidence of the use of specific brand-named BT for what it terms off label cosmetic (or vanity/aesthetic) uses and evidence that the same trade name of BT has been tested under Licence within the defendant’s regulatory scheme, it has not provided any evidence of a direct link between a batch of BT tested under Licence being the same batch (or part of a batch) of BT prescribed for pure cosmetic use without any, even therapeutic, need. Or, indeed that any specific Licencee has knowingly (or in circumstances where it would be taken to have constructive knowledge) tested a batch of BT intended for purely cosmetic use, in whole or in part.

Accordingly, the evidence does not disclose that part of any batch tested under one of the defendant’s Licences, with the appropriate limitations and information on intended use recorded, has later been diverted to non-medicinal, off label cosmetic applications. If there were evidence that this occurred, particularly on a systematic or regular basis, then the whole regulatory framework would need reform.

Both parties agree that the defendant is obliged to take reasonable steps to ensure that the batches of BT tested on animals are only used for medicinal purposes. The defendant has set out the steps that she is taking. The parties agree that sections 10, 11 and 18 of ASPA accord discretion to the defendant as to what appropriate enforcement measures are. The defendant has repeatedly sought suggestions from the claimant has to what reasonable further enforcement mechanisms she might employ.

The requirement for a market authorisation such as from MHRA is one important method of enforcing the relevant limitation. It covers the “on label” application of the product concerned and is part of the enforcement process but is not limited to it. This is an important feature because as BT can only be used under prescription all BT products have such market authorisation. The market authorisation does not itself limit the use to which the BT product can be put.

The additional requirement directed at ascertaining the end use of the product being tested under Licence is, as set out by Dr MacArthur Clark the then head of ASRU, that written confirmation is obtained and recorded by the Licence holder as to the intended use of the batches of BT tested under Licence. This is confirmed to the defendant and her inspectors check the records are in accordance with the terms of the Licence at regular inspections.

In my judgment, the material provided with Mr Reynolds’ statement demonstrates that the defendant’s requirements do not start and end with a marketing authorisation. The Licencee is required to satisfy the defendant that the end-use of the BT submitted for testing is as a medicinal product. There is evidence that the 2011/12 judicial review proceedings led to a change in the defendant’s methods.

The ‘decision’ of 4 May 2016 which precipitated this application for judicial review was not a decision at all. Nothing in the defendant’s approach had changed and I do not accept that the claimant had been misled. The discussion at the meeting held on 4 May 2016 appears to have moved from how to give effect to the purpose and limits of the regulatory process, to how to prevent BT tested entirely in accordance with the Licence then being used for non-medicinal purposes. This would be outside the terms for which the testing had been Licenced but would not have to go as far as to be illegal. An example is the prescription by appropriately qualified medical professionals for BT to be injected for non-physiological or psychological treatment i.e. pure vanity. Although not illegal (in the sense that it would be administered under prescription) this use of BT tested on animals under the defendant’s Licence can reasonably be described as a failure of the regulatory process which is designed, as I have observed to prevent the safety testing of cosmetics on animals.

However, the regulatory scheme of the ASRU does not extend to monitoring the actual end use of every vial of BT in batches that have been tested under one of the defendant’s Licences. The scheme restricts the anticipated end use by limiting the availability of Licenced animal testing for batches of BT to those that carry a marketing authorisation as a medicinal product which is to be used for medicinal purposes. The limitation could not be clearer and there is no dispute that it is intended to have an effect. In order to demonstrate that testing is being done within the proper limits the scheme requires the Licence holders, such as Wickham under its 2014 Licence, to obtain and record information on the intended or anticipated use of the BT prior to carrying out the testing. There is no other rational point of anticipation.

The claimant is deeply troubled by the breadth of the circumstances in which doctors can prescribe BT outside the medical purpose for which it was authorised, off label but not even for psychologically justified therapy but for such trivial motivation as a wish for a more youthful appearance. It is not the defendant who controls good prescribing practices, even in the United Kingdom. The remedy must be an approach to the medical regulator.

The three grounds of claim initially mounted have largely fallen away. The claimant now seeks a declaration in terms set out by Mr Thomas in a letter to the claimant on 13 July 2017. The defendant does not consent to the declaration sought which is:

“1.

The relevant Licence does not permit testing on animals of BT where the end use of the toxin is vanity (i.e. where its administration is not to address a recognised psychological or physiological condition).

2.

The Licence holder must satisfy himself, prior to testing on animals, that the manufacturer has reasonable measures in place to ensure that a batch from which BT samples are tested on animals will be used only for medicinal purposes (i.e. to address a recognised psychological or physiological condition).

3.

Similarly, the defendant’s duty is to ensure that the Licence holder has, prior to testing on animals, information showing that such measures are in place.

4.

Provided such information is available at that time, the Licence holder would not be in breach of his Licence, and the defendant would not be a breach of her enforcement duty, simply because BT from a batch which the Licence holder has test on animals is later used for vanity purposes. For the avoidance of doubt, the existence of a marketing or clinical trial authorisation for the BT product in question does not by itself constitute a reasonable measure.”

The Licence term set out in paragraph 7 above and as applied since 2012 does satisfy the defendant’s duty to enforce the statutory regulatory regime. There is no ambiguity therein. It is BT for medicinal products that may be tested under Licence not BT for pure cosmetic/vanity products. Any Licencee who knowingly tested batches which he knew in whole or in part to be intended for vanity prescription would be, prima facie, in breach of the Licence condition. The harm/benefit analysis carried out in 2014 before the relevant Licence was renewed to Wickham appears, on the evidence before me to have been consistent with the defendant’s long-standing policy that cosmetics cannot be lawfully tested on animals. Finally, there is no evidence at all that the claimant has been misled by the defendant despite the at times somewhat confused presentation of the defendant’s position by those required to carry out regulatory roles. A difficulty remains with the proposed declaration: how is the moment at which the anticipated end use is assessed to be determined?

For the reasons set out in the body of this judgment, there being evidence that the Secretary of State is doing what she agreed to do in exercising her regulatory functions under the 1986 Act in 2012 and no evidence that the defendant has failed to react appropriately to a breach of the condition that ASPA Licencees must adhere to namely, to test BT to be used for medicinal products in accordance to registered marketing authorisations held with national and international regulators and in accordance with Good Manufacturing Practice, this claim for judicial review must be dismissed.