England and Wales High Court (Administrative Court) Decisions

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

		Royal Courts of Justice Strand London WC2A 2LL
		8 June 2016

MR JUSTICE COLLINS:

1. This claim stems from the EU Directive on the protection of animals used for scientific purposes of 20 October 2010. The decision under attack is one made on 21 July 2014 by the defendant granting exemption from a provision in the Directive that there should be an outside run provided for dogs. The Directive has been transposed into our law by means of amendments to the Animals (Scientific Procedures) Act 1986. It is I think unnecessary for me to refer to both the Directive and the Act, since the transposition is pretty well verbatim from the provisions of the Directive.
2. The interested party, B & K Universal Limited, has since the 1970s been involved in running at Grimston near Hull an establishment to provide animals, in particular dogs, for scientific purposes. In 2010 it ceased breeding dogs but applied for planning permission to redevelop the site. The establishment was within what had been the walled garden of a Grade I listed building with Grade II* listed stables. It was said then that outside runs would not be provided for the dogs, the dogs in question being beagles. The reason for that was partly because of a planning objection, namely the noise that would result from dogs barking in outside runs. That application was refused.
3. In 2013 there was a renewed application for permission for development, together with listed building consent, and in the planning inquiry there were in effect two issues, namely the effect of the development on the listed buildings and the noise issue which it was said would effect those living nearby. The Secretary of State for Communities and Local Government called in the application and allowed it, but it contained a condition that there should be no outside runs for the dogs. That was possible because of the decision by the defendant in this case, which was given as I have said on 21 July 2014, which exempted from the requirement which otherwise would have existed to provide an outside run.
4. The claimants only appreciated that the exemption had been granted after the planning permission decision was made. Accordingly they made an application that this claim be allowed to proceed out of time. Blake J granted permission and extended time. Delay has not been raised as an issue before me.
5. It is I think convenient to deal with the law by reference to the Directive. It of course has direct effect even if not expressly put into effect in domestic law, but as I say it has been through a provision in the 1986 Act which permitted secondary legislation to amend the provisions of the Act, and that is the way in which it has been done.
6. It is I think desirable to refer to one or two of the preambles to the Directive. They make clear that what lay behind the Directive was the need to ensure that animals were properly treated and their welfare was kept under review, following from Article 13 of the Treaty on the Functioning of the European Union which provides:

"In formulating and implementing the Union's agriculture, fisheries, transport, internal market, research and technological development and space policies, the Union and the Member States shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting the legislative or administrative provisions and customs of the Member States relating in particular to religious rites, cultural traditions and regional heritage."

7. Obviously among other things that would encompass slaughter of animals, for example, for halal or Jewish requirements, and no doubt there are other matters which would fall within that.
8. Going back to Article 1 of the preamble, it refers to disparities in the provisions in Member States in relation to animal welfare and concludes:

"These disparities are liable to constitute barriers to trade in products and substances the development of which involves experiments on animals. Accordingly, this Directive should provide for more detailed rules in order to reduce such disparities by approximating the rules applicable in that area and to ensure a proper functioning of the internal market."

Preamble 2 refers to Article 13 of the Treaty.

Preamble 6 provides that:

"New scientific knowledge is available in respect of factors influencing animal welfare as well as the capacity of animals to sense and express pain, suffering, distress and lasting harm. It is therefore necessary to improve the welfare of animals used in scientific procedures by raising the minimum standards for their protection in line with the latest scientific developments."

9. provides:

"Animals have an intrinsic value which must be respected. There are also the ethical concerns of the general public as regards the use of animals in procedures. Therefore, animals should always be treated as sentient creatures and their use in procedures should be restricted to areas which may ultimately benefit human or animal health, or the environment. The use of animals for scientific or educational purposes should therefore only be considered where a non-animal alternative is unavailable. Use of animals for scientific procedures in other areas under the competence of the Union should be prohibited."

10. That obviously is directed, for example, to the prohibition of the use of animals for experiments which are for purely cosmetic purposes and not for human health or indeed animal health.
11. Preamble 35 is again of relevance. It provides:

"There are differences in the requirements for the accommodation and care of animals between Member States, which contribute to the distortion of the internal market. Furthermore, some of those requirements no longer reflect the most recent knowledge on the impacts of accommodation and care conditions on both the animal welfare and the scientific results of procedures. It is therefore necessary to establish in this Directive harmonised requirements for accommodation and care. These requirements should be updated on the basis of scientific and technical development."

12. It is not I think necessary to refer expressly to any other of the preambles.
13. The relevant articles for our purposes are 4, 20 and 33. Article 4(3) provides:

"Member States shall ensure refinement of breeding, accommodation and care, and of methods used in procedures, eliminating or reducing to the minimum any possible pain, suffering, distress or lasting harm to the animals."

Article 20 requires that all breeders, suppliers and users of such animals must be licensed.

Article 33 has the heading "Care and accommodation", and paragraph 1 sets out various matters that are material for care and accommodation of animals, including that restrictions on the extent to which an animal can satisfy its physiological and ethological needs are kept to a minimum; that means that any restrictions which may affect its health and welfare must be kept to a minimum. Paragraph 2 provides:

"For the purposes of paragraph 1, Member States shall ensure that the care and accommodation standards set out in Annex III are applied from the dates provided for therein."

But 3 provides:

"Member States may allow exemptions from the requirements of paragraph 1(a) or paragraph 2 for scientific, animal-welfare or animal-health reasons."

14. Annex III, again so far as material, commences with general provisions and 1.1(a) provides, under the heading "The physical facilities - functions and general design":

"All facilities shall be constructed so as to provide an environment which takes into account the physiological and ethological needs of the species kept in them. Facilities shall also be designed and managed to prevent access by unauthorised persons and the ingress or escape of animals."

Dogs are specifically dealt with in paragraph 4, which provides, and this is the important provision for the purposes of this case:

"Dogs shall where possible be provided with outside runs. Dogs shall not be single-housed for more than 4 hours at a time.

The internal enclosure shall represent at least 50 per cent of the minimum space to be made available to the dogs, as detailed in [the table which follows]."

15. It is said "The space allowances detailed are based on the requirements of beagles," the reason for that no doubt being that it seems that the dogs most often used for the purpose of scientific experiments are beagles, but obviously other dogs can be used and are used in certain circumstances. Beagles are treated as, as it were, the norm.
16. It is accepted that the provision of Annex III, that "dogs shall where possible be provided with outside runs", is obviously to be read in conjunction with the possibility that is provided for in Article 33(3), that there may be exemptions for scientific reasons, because it is scientific reasons that have provided for the exemption in this case. It is not a question simply whether it is possible or it is a matter of the arrangement of the site. For there to be outside runs clearly is possible, because there have been in the past outside runs at this establishment, but that is not the be all and end all of the requirement.
17. As I say, not only is that common ground, but the defendant sought advice from the Commission as to the extent of what was covered by Annex III, and received the answer that it did extend in the way that I have indicated. The only reason I dwell on that at all is that in the way it was presented in the skeleton argument it looked as if it may have been said that provided outside runs were physically possible, that meant that they had to be provided, but that is not what the legislation requires.
18. But outside runs inevitably must mean that there cannot be complete enclosure, because otherwise that would not be an outside run. The importance of that is that the purpose of the exemption is to ensure that the dogs kept in the establishment and provided for the scientific purposes, essentially toxicological concerns, should not be infected with any pathogen. Such pathogens can come from insects, from other animals, mice for example or rats, and birds, and that would extend to bird droppings, and of course insects including fleas, possibly ticks, but many flying insects as well. It thus would, in my judgment, be impossible to avoid the possibility of such infection -- if infection be the right word, I think it is clear what I mean by it -- unless the whole was enclosed, and the whole cannot be enclosed because that would mean that it was not an outside run.
19. It was suggested by Dr Taylor, who has given statements on behalf the claimants, that there might be a possibility of ensuring, by means of protection of the outside runs, that there should not be any real risk. She dealt with that at paragraph 74 of her first statement, in dealing with a consideration of the microbiology report which had been provided by the interested party, she said:-

"The microbiologist was considering the possibility of pathogen transmission to dogs in the outdoors generally, not to dogs in outside runs. There is a world of difference. It is impossible to protect dogs in the outdoors generally from much pathogen transmission. But that is not the case with dogs allowed access only to outside runs. For example, there is no reason why barriers cannot prevent rodent ingress into outside runs (much easier to achieve, in fact, than preventing rodent ingress into large buildings): that would remove that potential source of pathogen transmission. Faecal transmission can be prevented by barriers (for rodents) and a perspex roof (for birds). Similarly, waterborne transmission is not an issue with properly constructed outside runs."

20. No doubt so far as that goes it may well provide for some protection, but it cannot deal, for example, with insects, and equally it is difficult to see how it can ensure that pathogens cannot be passed through by various means to dogs that make use of such outdoor runs. That aspect was not developed by Mr Clarke, and properly so.
21. The application by B & K set out in writing the reasons why it was said that an exemption was needed. Under the heading "Infection Control", it was said that:

"We are a breeding and supplying establishment providing high quality animals which are destined primarily for safety studies, so it is imperative that we also protect and preserve the biosecurity of the entire animal population we produce. Over 80 per cent of the scientific procedures carried out on dogs in 2012 were legally required to be performed to establish the safety and efficacy of the material under test."

22. It pointed out that pathogens were carried by insects, birds and vermin, and set out the various problems that could result from any such infection. It went on:

"Beagles are supplied to research facilities worldwide, and the consistent trend for is customers to require increasingly controlled environments in our breeding facilities. We believe that outdoor runs would contribute to a decline in the health status of our dogs, endangering both their welfare and the likelihood of customer acceptance. Suitably designed indoor housing can provide similar benefits to outdoor runs without compromising animal health."

23. They made the point that sufficient attention needed to be applied to the indoor facilities, and those facilities would be monitored by the inspectorate under the control of the defendant, to ensure, as is a requirement of the Directive, that the situation in the particular establishment was maintained so as to promote the welfare of the animals in it.
24. There was a visit paid by the inspector who was concerned in the decision making. She has been referred to as Inspector C because I think she has left the inspectorate now and has not been available to give evidence, but that is not important because what is relied upon is her report. There was some concern raised by the claimants that that report postdated the decision. The report was in the context of the knowledge of this claim being made and was simply a factual indication of what she had dealt with and the steps that she had taken. In fact there have been a number of emails disclosed which predate the decision, and on 8 July Inspector C -- this is an internal memo I think -- indicated as follows:

"I think what is of particular relevance is that B & K provides access to the outside and that over the last few years their dogs have suffered a number of health issues due to infections. It cannot be either proved or ruled out that outside access was the source. I would consider it reasonable for clients to have a desire for a more reliably healthy animal and I know that there have been occasions when animals have been rejected on the basis of health status. I am planning to visit [a] dog breeding colony on Friday so I will make some discrete inquiries about their current thinking on the source of the various infections that have occurred."

25. In her preliminary review, she stated that it was important to note the general requirements under Annex III, section A, 1.1, to which I have already referred, and that therefore should outside runs not be possible, for example for hygiene, health, scientific reasons, sufficient attention should be made to indoor facilities so as to ensure animal physiological and ethological needs are met. That is precisely what the Directive requires.
26. She referred to the B & K application. She made the point that the animals were being bred mainly for safety assessment testing, for which animals harbouring some infections would be unsuitable, and such infections could also have welfare implications. She goes on:

"The application is not accompanied by a statement that this is a client request, but my inquiries of other inspectors have revealed that pharma and CRO companies that are conducting safety testing in dogs in the UK do not provide outside access at their own facilities.

It is noteworthy that dogs are bred in the UK in facilities with access to the outside. In recent years [particular] dogs have suffered a number of health issues due to infections."

She concluded:

"It seems reasonable that clients should require a reliably healthy animal. Keeping the animals indoors could facilitate this by eliminating a number of sources of infection."

27. The decision was in these terms:

"I am responding to your request for exemption from providing access for outside reasons for dogs in respect of your proposal for a new breeding and housing building. Directive 2010/63/EU section B, 4 states: 'Dogs shall where possible be provided with outside runs.' The burden of proof is on the operator to justify why it would not be possible in a specific case. This must be considered on a case by case basis by the competent authority -- in this case, the Home Office."

Pausing there, it is accepted that that is an entirely correct statement of what the law requires of the licensing authority. The decision letter continues:

"You have stated that you will not be providing access to outside runs for the dogs because there is a need to protect the health status of the animals from pathogens in the environment that may be transmitted by wild rodents, insects and birds. The animals are bred mainly for safety assessment for which the potential transmission risk of certain pathogens renders an outdoor run, with such risk inherent, being unsuitable.

Your application has been carefully considered by inspectors, with reference to the requirements of the Directive, as transposed into the [1986 Act]: to provide access to outside runs where possible. Our finding is that access to the outside might expose the animals to pathogens which could result in them becoming unsuitable for the intended scientific purpose. Therefore, in conclusion, we consider your request for exemption is acceptable."

28. The additional matter which has also been referred to, although it was not explicitly referred to in the emails or in advance, is contained in the observations made by Inspector C picked up in the evidence given by Dr MacArthur Clark. Inspector C deals with two important matters. First, in relation to information about local prevalence of the individual infections, she said this:

"I did not seek information about the local prevalence of the individual infections listed by B & K because I did not consider that this would be helpful in informing a decision. The presence or absence of a particular infection in local vectors is not a static situation. Even if this information was readily available (which it is not) the situation today cannot be regarded as what it might be in six months or six years. What is important is the principle that vectors may transmit infections and that the risk of this can be minimised by excluding contact with the vectors. Also, there are some infections, such as the already mentioned Yersinia enterocolitica, which are widely found in vectors and which should be expected to pose a risk to animals which spend time outside."

Then she also refers to another matter. She says:

"My conclusion considering all the above was that the request for exemption from providing outside runs to preserve the health status of the animals imported from America and their offspring was reasonable. A significant consideration was that [blank], which provides outside exercise in their breeding colony, have in the last few years suffered a number of health issues in dogs due to infections."

29. The reference to America is of some importance, because one of the matters which was clearly referred to by Inspector C, so she was given the information, was that the interested party has imported dogs from America which have not and could not have been exposed to pathogens, and it is thus of the greatest importance that the facilities that are provided are such that avoid the possibility, so far as that can be achieved, of any infection from pathogens. That can be achieved by indoor rather than outdoor runs for the dogs in question. That is obviously an important factor which could properly affect the decision reached in the circumstances of this case.
30. The claim as finally put in argument by Mr Clarke was really based on two matters. It essentially was that there had been a failure by the defendant to have regard to material considerations. The first is an assertion that the terms of the letter granting the exemption, and in particular the second sentence in the second paragraph, namely, "the animals are bred mainly for safety assessment for which the potential transmission risk of certain pathogens renders an outdoor run, with such risk inherent, being unsuitable," meant that every case in which animals were kept for the purpose of scientific research would have to be granted an exemption, and that is not in conformity with the requirements of the legislation.
31. But that does not follow from the decision in this case. It was based upon the individual circumstances of the interested party in this case, and the concerns which it expressed. It is accepted that there are establishments which keep dogs for scientific purposes which do provide outdoor runs, and in certain circumstances that clearly is possible. The decision letter must be read in context, and in the knowledge that it follows the specific request and the circumstances of that request made by the individual in question, namely in this case B & K. It does not follow from the decision that every case must be dealt with in that way, so that an exemption will be always required.
32. Dr MacArthur Clark deals with this issue at paragraph 29 her statement, in which she says:

"The claimant asserts that this amounts to an acceptance that outside runs are unsuitable for dogs intended for toxicology studies. This conclusion may ultimately prove to be correct although of course each case depends upon its own facts. But this does not mean that all research dogs in the UK will be denied access to outside runs."

Then she refers to the number of establishments where outside runs exist.

33. If it indeed be shown, and scientific advances make clear, that it would be unacceptable for dogs which are to be used for toxicology studies to be in any way exposed to pathogens, and therefore outside runs would not be suitable, then so be it. That would unfortunately be the effect. I say "unfortunately" because obviously it is in the interests of dogs, because what lies behind the requirement for outside runs is that they are the best that is needed to ensure their welfare. But proper indoor runs can provide, so far as is possible, for their welfare to be maintained. I do not regard the possibility of exemptions being allowed if requested where dogs are required for toxicology studies to mean that there is any breach of the law. The question of possibility in relation to outside runs must be considered in the context of any application that is made and the circumstances of such an application, and I have no reason to doubt that the case by case approach is not going to be adopted, indeed Dr MacArthur Clark makes clear that that is indeed the approach that will be adopted.
34. Secondly, it is said that the failure to consider the local conditions in respect of pathogens is a failure to have regard to what clearly was a material consideration. It was clear from Inspector C's statement, taken up by Dr MacArthur Clark, why she took the view that it was not necessary, or indeed sensible, really, to try to find out what local conditions were. It cannot be suggested that there is an absence of any possible pathogens in this particular place. Accordingly, the fact that there is the possibility of pathogens being transmitted is all that is required to be shown.
35. Mr Clarke submits that it is necessary to consider the extent of the risk in any given case, but it would not be possible to establish that from any sensible approach to local conditions. I say that because in order to discover what was the precise position in any locality, and in this locality, would, I have no doubt, even it were possible to establish, involve considerable work and time and expenditure of money, and for what purpose? The answer in my judgment is no sensible purpose in the context of the decision that had to be made.
36. Indeed, Inspector C makes the point that there is no such evidence available and the circumstances are not necessarily static. Assuming one could have a test of the situation at a given moment in time, it could change depending on circumstances, depending on what wildlife, perhaps, attends the area. After all, when one is dealing with birds one knows that they will migrate, and birds coming from Africa may produce pathogens which are not generally known in this country. Equally, we have winter visitors from Europe and the north. That is only one example of the changing circumstances which could arise. I am, I am afraid, clear that the failure to consider local conditions was entirely justified.
37. In those circumstances, I am afraid I have to conclude that this claim cannot be made out and therefore I dismiss it.
38. I should only add this: that there has been reference to previous cases involving challenges to decisions of the Secretary of State through the inspectorate. The point has been made that in this sort of situation, where one is dependent upon a decision by scientists who have the necessary expertise, this court should be very slow to reach a conclusion that there has been a breach, particularly where that breach is alleged to be essentially on Wednesbury grounds. I take note of that, but as I have indicated, whatever level of approach is appropriate, in my judgment the claim does not reach anywhere near that level.

MR GREATOREX: My Lord, I am grateful to your Lordship for giving judgment today. There is just the matter of costs.

MR JUSTICE COLLINS: Yes.

MR GREATOREX: We don't have a schedule, I'm afraid. Schedules weren't actually exchanged between either party, I'm not entirely sure why.

MR JUSTICE COLLINS: Yes. Mr Clarke, you can't resist an application for costs, can you?

MR CLARKE: My Lord, if I can take instructions. (Pause)

My Lord, on the principle, my instructions are to say that no order for costs would be the appropriate order, for the short reason that this is a charity acting in the public interest and that it didn't have any private interest in the outcome.

MR JUSTICE COLLINS: Well, you say acting in the public interest. Yes and no. I mean, it acts in its interest, which may or may not, in this sort of case, be in the public interest. I'm not deciding one way or the other on that, but I don't think you can frankly rely upon that. If even a charity chooses to engage in judicial review court proceedings, then normally it will face the costs if it loses.

MR CLARKE: My Lord, it's a short point, we say there's no direct gain for this claimant in pursuing this litigation, it has pursued it to try and clarify the law on the point.

MR JUSTICE COLLINS: No, I understand, it's felt that it's an important point. But so far as an award of costs is concerned, that is not a reason not to award costs. If you can persuade the Home Office not to enforce, that's another matter.

MR CLARKE: My Lord, you have the points insofar as I can make them.

MR JUSTICE COLLINS: No, I'm afraid I think that the normal rule should apply. You're not applying, Mr Fry, I take it?

MR FRY: My Lord, no.

MR JUSTICE COLLINS: You wouldn't get anywhere if you did, as you probably know.

All right, in that case what I'll say is the usual order, that it be the subject of detailed assessment if not agreed, and obviously, Mr Greatorex, you will serve your necessary schedule. I don't think it's necessary for me to put any time limit, is it, or is it? I'm happy to do so.

MR CLARKE: I'm sure that something can be agreed.

MR JUSTICE COLLINS: You discuss it.

MR CLARKE: My Lord yes.

My Lord, that simply leaves permission to appeal. I do ask for permission to appeal on the grounds that -- essentially the point I ran this morning, we say that there is a real prospect of another court taking a different view as to whether or not the approach that my Lord has described is one which is properly envisaged and permitted by the terms of the Directive, both as to essentially the principle of risk question, which has been explored, and secondly the relevance of the risk of infection at the particular site, and in terms of the reasons for that, you have my submissions.

MR JUSTICE COLLINS: Yes, I have had your submissions. No, Mr Clarke, I am not going to grant leave to appeal. I don't think that there is a reasonable prospect of success in the Court of Appeal. You may know the Court of Appeal is proposing to change that to a much higher ...

MR CLARKE: Certainly, I'm aware of the discussions that are being had.

MR JUSTICE COLLINS: But even at the moment I don't think that there is on the facts a reasonable chance.

MR CLARKE: My Lord, I'm obliged.

MR JUSTICE COLLINS: You will have to persuade the Court of Appeal if you wish to take it further.

MR CLARKE: Quite so.

MR JUSTICE COLLINS: All right. Well thank you all three very much.