England and Wales High Court (Administrative Court) Decisions

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

		The Court House Oxford Row Leeds LS1 3BG

The claim

1. The claimant, Chiltern Farm Chemicals Ltd, seeks judicial review of a decision of the Chemicals Regulation Division (CRD), a division of the defendant, the Health and Safety Executive. Mr Tim Ward QC and Mr Robert Palmer represent the claimant and Mr Adam Heppinstall and Mr Jonathan Lewis represent the defendant. Permission to bring the claim was granted by His Honour Judge Sycamore on 18 May 2017.
2. The decision about which the claimant complains is dated 29 January 2016 by which the CRD concluded that a bird field monitoring study undertaken on behalf of the claimant and entitled "Attract (metaldehyde based slug pellets containing Guardsman repellent): field monitoring of effects on birds. Final Report Study Director Phil Prosser" (the Prosser Study) was a vertebrate study subject to the data sharing provisions of Article 62 of Regulation 1107/2009 of the European Parliament and of the Council (the Regulation).
3. The introduction to the Prosser Study cites its purpose and objective as collecting further data because:

"the effect on granivorous and omnivorous birds was required for registration, since there may be risks to birds both from directly consuming slug pellets, and from consuming contaminated slugs and other vertebrates."

4. The Regulation provides a regulatory basis aimed at ensuring that pesticides (also known as plant protection products) are safe to use and that the method by which their safety is established is appropriately sympathetic to humans, wildlife and the environment.
5. I shall of course deal with the legislation in more detail below but at this point, and in order to put matters into context, it is right to explain the rationale behind the Regulation and the data sharing requirements contained in Article 62.

[Diagram or picture not reproduced in HTML version - see original .rtf file to view diagram or picture]

6. The primary purpose of the Regulation is set out in Article 1(3) namely:

"to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production".

7. One of the important aims of the Regulation is to reduce, so far as possible, the amount of experimentation that is conducted on vertebrates. Recital 40 of the Regulation provides:

"The use of non-animal test methods and other risk assessment strategies should be promoted. Animal testing for the purposes of this Regulation should be minimised and tests on vertebrates should be undertaken as a last resort. In accordance with Council Directive 86/609/EEC (the 1986 Directive)^[1]… tests on vertebrate animals must be replaced, restricted or refined. Therefore, rules should be laid down to avoid duplicative testing and duplication of tests and studies on vertebrates should be prohibited. For the purpose of developing new plant protection products, there should be an obligation to allow access to studies on vertebrates on reasonable terms and the results and the costs of tests and studies on animals should be shared. In order to allow operators to know what studies have been carried out by others, Member States should keep a list of such studies even where they are not covered by the above system of compulsory access".

8. Article 62 provides the means by which duplicative testing and duplication of tests and studies on vertebrates is to be avoided. In brief, it does so by requiring those who have performed such an experimental or scientific study to permit others to rely on its results (in return for a contribution to the costs of producing it^[2]) and by preventing others from being permitted to rely upon any further studies.
9. The aim of Article 62 is one to which, I am told, the claimant wholeheartedly subscribes. It simply argues that CRD's interpretation and application of Article 62 by which they have characterised the Prosser Study as a vertebrate study which thus entitles others to rely on it "distorts the language and purpose of the Regulation in such a manner as to benefit the claimant's competitors without creating any corresponding advantage to the protection of birds of any kind".
10. It is therefore contended by the claimant that the decision that the study was a vertebrate study subject to the data sharing provisions of Article 62 was unlawful and/or irrational and it seeks a declaration to that effect. By its Statement of Facts and Grounds, the claimant seeks some additional relief which would appear to be a corollary to that declaration and would thus inevitably follow on from a declaration to the effect that the claimant is right when it argues that the decision was irrational or otherwise unlawful.

The context of the claim

11. The claimant is a producer of slug pesticides for both the domestic market and professional agricultural market in the UK. The active ingredient in Chiltern's slug pellets is metaldehyde. The claimant has been authorised to market and supply the slug pellets containing metaldehyde for many years. However, as a result of developments in the regulatory process that have taken place, it became necessary for the claimant to seek re-authorisation of its slug pellets.
12. Since 1986 the supply of plant protection products such as slug pesticides has been regulated. Initially by the Control of Pesticides Regulations 1986 and more latterly by regulations emanating from Europe in the shape of Council Directive 91/414/EEC dated 15 July 1991 (the Directive) and subsequently the Regulation. The Directive aimed at harmonising, as far as possible, the approval of active substances and the arrangements for the authorisation of plant protection products within the EU and for ensuring that they were safe to use. With effect from 14 June 2011 the Directive was repealed and was superseded by the Regulation.
13. There are inevitably regulatory arrangements to deal with the transition between the Directive and the Regulation. It seems to me to be unnecessary to go into these in any great detail. It is common ground that, since, for reasons I shall come to, the requirement for the re-authorisation of metaldehyde products was triggered on 1 June 2011, before the Regulation came into force, the application for re-authorisation was and is to be decided on the basis of the national law in force before the Regulation took effect. Indeed, it appears that is the inevitable effect of Article 80(5)(b) of the Regulation which states that

"Applications for authorisations of plant protection products … which are due to be amended or withdrawn following an inclusion in Annex I to Directive 91/414/EEC or following an approval in accordance with paragraph 1 of this Article on 14 June 2011 shall be decided on the basis of national law in force before that date".

14. It is agreed however that Article 62 of the Regulation applies in this case in any event notwithstanding Article 80(5)(b). This is because certain procedural aspects of the Regulation apply to applications for reauthorisation (sometimes called re-registration) even in respect of pre-existing applications. That includes the provisions governing access to data which are the bone of contention in this case.
15. It also appears to be agreed that, in a similar way to the Directive, the Regulation put in place a 2 tier registration system for the authorisation of plant protection products. The first tier of the registration system involves the assessment of active substances by a Rapporteur Member State on behalf of the EU for approval against a set of agreed criteria. I am told that this is Austria for metaldehyde. Before an active substance can be approved the company seeking approval must submit a complete data package or dossier on both the active substance and at least one formulated plant protection product containing that active substance. The dossier must show that the active substance is without unacceptable risk to humans, animals or the environment.
16. Following assessment by a Member State there is a review by the European Food Safety Authority which itself provides its conclusions to the Commission which either approves or does not approve the active substance in light of the conclusions as to the safety of the product. Their proposal is then put to a vote of the Standing Committee on Plants Animals Food and Feed which comprises of representatives from all the member states. If approved an active substance is placed on the approved list of active substances contained within Commission Implementing Regulation EU 540/2011. Approval is initially for a maximum period of 10 years, it is renewable and can be subject to conditions.
17. Metaldehyde was approved as an active substance under the first tier of the registration system with effect from 1 June 2011 and was thus included in the Directive at that point^[3]. It will be remembered that the Regulation only came into effect on 14 June 2011 some 2 weeks later. The effect of approval was that metaldehyde was included in Annex 1 of the Directive. As I have said, the effect of the inclusion of metaldehyde in Annex 1 of the Directive was to trigger a requirement for plant protection products with the active substance, metaldehyde, to be re-authorised or re-registered, notwithstanding that they had been in use for many years.
18. The defendant argues that the rationale for re-registration was that safety standards, particularly in relation to minimising harm to animals and the environment, have become more stringent over the years. It does not necessarily follow therefore that plant protection products currently on the market and authorised under prior legislation would meet the safety standards now demanded.
19. As a result therefore of the approval of metaldehyde as an active substance and its inclusion in Annex 1 of the Directive, it became incumbent upon the claimant to engage in the second tier of the registration process which involves the re-authorisation of its plant protection products known as Allure and Attract (which are aimed at the professional agricultural market) and, for the domestic market, Slug Ban. This was because they contain metaldehyde, albeit apparently in smaller concentrations than can be found in the products of its competitors. Without the necessary re-authorisation the claimant would be unable to continue to supply its metaldehyde based products in the UK.
20. This authorisation is undertaken by an agency of a Member State although, as I understand it, not necessarily the Member State in which the applicant is situated. Be that as it may, in the UK the agency is the defendant operating through the CRD. Article 33 of the Regulation sets out the procedure for making an application for reauthorisation.
21. This second tier is itself subdivided into 2 separate steps. The first involves CRD reviewing any existing UK authorisations to ensure that products comply with any conditions of approval in respect of the active substance from the first tier. The second step involves the submission by the applicant company of a full product data package including a dossier which satisfies the requirements of the Regulation. CRD will then evaluate the authorised product in accordance with the principles of EU law and consider the authorisation of that particular plant protection product. The dossier considered by the CRD is divided into a number of different sections each requiring a separate expert evaluation. One such section is ecotoxicology which involves a consideration by the CRD of the effect that the plant protection product will have on birds and mammals.
22. This claim is concerned only with the decision by the CRD in the context of this second stage of the second tier of its consideration of the product and in the specific context of the eco-toxicology section of the dossier and its conclusion that the Prosser Study, included as part of the ecotoxicology section of the dossier, should be available to other companies seeking approval of their plant protection products under the data sharing provisions of Article 62.
23. The claimant objects to data sharing of the Prosser Study not only because it concludes that under the Regulation it is inappropriate in principle but because it would give its competitors a wholly unfair advantage.
24. The claim is supported by a witness statement of Mr Philip Tavener. He and his wife, Sally are described as the joint owners of the claimant. He argues that the submission of the claimant's application for re-registration, in particular its dossier in support of its application is the result of a considerable amount of hard work and time. 7 reports in relation to 6 studies on birds and mammals have been commissioned as part of the ecotoxicology risk assessment, 2 avoidance studies on birds, 2 avoidance studies on mammals, one field monitoring study on birds and one field monitoring study on mammals. It has spent over £3 million on its data package and over £400,000 on these reports. The Prosser Study, which is the exclusive focus of this claim, itself cost £174,100 not including VAT.
25. Albeit that Article 62(6) provides that companies that access a report commissioned by another for purposes connected with the authorisation of their plant protection products must pay for the privilege, as I have said, it is Mr Tavener's position that the compensation that the claimant would receive under this provision would be wholly inadequate and well below its commercial value because it would not compensate for the time that has been spent on producing this evidence, time which could have been spent in otherwise promoting the company in other ways and it would provide companies which, are after all competitor companies, with a distinct advantage at the expense of the claimant simply because the claimant has taken a responsible view and got its house in order in the light of the changes in the legislation while others may not have done.

The legislative framework

26. Chapter V of the Regulation deals with data protection and data sharing. Data protection is defined as:

"the temporary right of the owner of a test or study report to prevent it being used for the benefit of another applicant" (Article 3(21)).

27. Mr Ward emphasised the fact that there is a general principle recognised in recital 39 of the Regulation that those who commission studies have a proprietary interest in them which is protected.
28. Recital 39 states so far as is relevant:

Studies represent a major investment. This investment should be protected in order to stimulate research. For this reason, tests and studies, other than those involving vertebrate animals, which will be subject to obligatory data sharing, lodged by one applicant with a Member State should be protected against use by another applicant …"

29. Article 59(1) reflects that general principle by specifying that:

"Test and study reports shall benefit from data protection under the conditions laid down in this Article".

30. It goes on to provide that:

"Where a report is protected, it may not be used by the Member State which received it for the benefit of other applicants for authorisation of plant protection products…except as provided in paragraph 2 of this Article, in Article 62 or in Article 80".

31. It is not suggested that the Prosser Study is exempted from data protection pursuant to Article 59(2) or Article 80. The sole issue is whether the defendant's decision that it is exempted from data protection under Article 62 is an unlawful and/or irrational one.
32. Mr Ward argues that Article 62 is a derogation from the general principle enshrined in recital 39 and Article 59. He argues that that is clear from the wording of Article 59 itself which simply makes data sharing an exception to the general rule that, where a report is protected, it may not be used by the Member State for the benefit of other applicants.
33. He argues that that is important because any derogation from a general right has to be interpreted strictly. He cites Infopaq International A/S v Danske Dagblades Forening Case C-5/08 of the European Court in which it is said, at paragraph 56:

"It should be borne in mind that, according to settled case law, the provisions of a directive which derogate from a general principle established by that directive must be interpreted strictly".

34. He also cites Germany v The Council, a further case before the European Court under reference C-280/93 which, at paragraph 78, suggests that while rights can be interfered with and restrictions imposed, those restrictions must:

"correspond to objectives of general interest pursued by the Community and do not constitute a disproportionate and intolerable interference, impairing the very substance of the rights guaranteed".

35. He argues therefore that Article 62, which simply makes vertebrates a special case in terms of data sharing, must be given a narrow meaning if it is to accord with European legislation.
36. Mr Heppinstall does not accept that Article 62 is a derogation from a general principle. His argument is that the Regulation establishes 2 equally important principles, the first being a proprietary interest in studies and the second, equally important provisions, providing for the welfare of animals by proscribing the unnecessary duplication of studies of animals. He argues that in the circumstances Article 62 is not a derogation, it is merely the assertion of the second of the 2 equally important principles.
37. Article 60 does not need to be recited or referred to at length. It simply provides for lists of test and study reports to be produced by Member States and for Member States to keep and make available to any interested party on request a list of the test and study reports. Article 61 requires any persons intending to seek an authorisation for a plant protection product to consult the publicly available information regarding plant protection products to ascertain to whom an authorisation has already been granted for a plant protection product containing the same active substance. They can request the competent authority to provide the list of test and study reports and the name and address of holders of previous relevant authorisations with the intention that those parties shall then take steps to reach an agreement on sharing any protected test and study reports "in a fair, transparent and non-discriminatory way".
38. It is up to the parties to agree the terms upon which any data is shared. If no agreement can be reached then the data is not shared. The owner of the data therefore can demand a price which takes account of the value of the data to the other party. Crucially however, that is not so in connection with studies relating to vertebrates. Article 62 provides a separate code relating to test and studies involving vertebrate animals.
39. As Mr Ward points out in paragraph 31 of the skeleton argument:

"Article 62 is a precise procedure and there is no other provision within the Regulation whereby data can be shared. If studies do not fall within the Article 62 data sharing provisions, they are protected in accordance with Article 59, with the result that other applicants can only rely on them if they have been granted a letter of access by the data owner following the reaching of agreement under Article 61(3)".

40. This is why Mr Ward argues that the provisions of Article 62 are a derogation from the general principle of data protection.
41. It is necessary to set out in full Article 62:

Sharing of tests and studies involving vertebrate animals

1. Testing on vertebrate animals for the purposes of this Regulation shall be undertaken only where no other methods are available. Duplication of tests and studies on vertebrates undertaken for the purposes of this Regulation shall be avoided in accordance with paragraphs 2 to 6.

2. Member States shall not accept duplication of tests and studies on vertebrate animals or those initiated where conventional methods described in Annex II to Directive 1999/45/EC could reasonably have been used, in support of applications for authorisations. Any person intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated.

3. The prospective applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way. The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements.

4. Where the prospective applicant and the holder or holders of the relevant authorisations of plant protection products containing the same active substance, safener or synergist, or of adjuvants cannot reach agreement on the sharing of test and study reports involving vertebrate animals, the prospective applicant shall inform the competent authority of the Member State referred to in Article 61(1).

The failure to reach agreement, as provided in paragraph 3, shall not prevent the competent authority of that Member State from using the test and study reports involving vertebrate animals for the purpose of the application of the prospective applicant.

5. By 14 December 2016, the Commission shall report on the effects of the provisions in this Regulation concerning data protection of tests and studies involving vertebrate animals. The Commission shall submit this report to the European Parliament and the Council accompanied, if necessary, by an appropriate legislative proposal.

6. The holder or holders of the relevant authorisation shall have a claim on the prospective applicant for a fair share of the costs incurred by him. The competent authority of the Member State may direct the parties involved to resolve the matter by formal and binding arbitration administered under national law. Otherwise the parties may resolve the matter through litigation in the courts of the Member States. Awards from arbitration or litigation shall have regard to the principles determined in paragraph 3 and shall be enforceable in the courts of the Member States."

42. It is right to remind myself that the heading of Article 62 makes it clear that it relates to the "sharing of tests and studies involving vertebrate animals". Article 62(1) emphasises that by making it clear that the Regulation relates solely to testing on vertebrate animals and the avoidance of duplication of tests and studies on vertebrates. It is not disputed that that definition includes birds.
43. The Regulation does not define which tests and studies are considered to be tests and studies involving vertebrate animals. This application arises because both parties have taken a different view as to its meaning. The claimant argues that the meaning does not encompass the work done in the Prosser Study, the defendant takes the opposite view. The issue therefore is one of construction of the meaning of Article 62.
44. Some help, although regrettably not definitive help, can be obtained from the regulatory framework.
45. Recital 40, to which I have referred above, makes it clear that tests on vertebrate animals must be replaced, restricted or refined in accordance with the 1986 Directive, which was transposed into domestic law by the Animals (Scientific Procedures) Act 1986 (ASPA)^[4].
46. Before I turn to that statute, let me look at the 1986 Directive. Not least because it is common ground that it is necessary to look at the 1986 Directive to understand what is meant by tests and studies on vertebrates.
47. The aim of the 1986 Directive was:

"to ensure that where animals are used for experimental or other scientific purposes the provisions laid down by law, regulation or administrative provisions in the Member States for their protection are approximated so as to avoid the establishment and functioning of the common market, in particular by distortions of competition or barriers to trade".

48. Article 2 of the 1986 Directive is a definitions section. It states, where relevant, that:

i. "animal" means "any live non-human vertebrate".

ii. "experiment" means "any use of an animal for experimental or other scientific purposes which may cause it pain, suffering, distress or lasting harm…but excluding the least painful methods accepted in modern practice (i.e. 'humane' methods) of killing or marking an animal; an experiment starts when an animal is first prepared for use and ends when no further observations are to be made for that experiment; the elimination of pain, suffering, distress or lasting harm by the successful use of anaesthesia or analgesia or other methods does not place the use of an animal outside the scope of this definition. Non experimental, agricultural or clinical veterinary practices are excluded". (My emphasis)

49. ASPA regulates any experimental or other scientific procedure applied to a protected animal that may have the effect of causing that animal pain, suffering, distress or lasting harm. A procedure so defined by the Act is referred to as a "regulated procedure". Any person seeking to undertake a regulated procedure must have a licence granted by the Secretary of State to do so.
50. Section 1(1) ASPA defines a "protected animal" as:

"Any living vertebrate other than man".

51. Section 2(1) before it was amended to accord with the 2010 Directive defined "a regulated procedure" as:

"Any experimental or other scientific procedure applied to a protected animal which may have the effect of causing that animal pain, suffering, distress or lasting harm". (my emphasis)

52. There is no definition in the Act of "experimental" but of course Mr Heppinstall argues that the definition of "experiment" in Article 2 of the 1986 Directive is of obvious assistance.
53. Section 2(5) states that:

The ringing, tagging or marking of an animal, or the application of any other humane procedure for the sole purpose of enabling an animal to be identified, is not a regulated procedure if it causes only momentary pain or distress and no lasting harm".^[5]

54. Section 2(8) excludes from the definition:

"references to any recognised veterinary, agricultural or animal husbandry practice".

55. The Home Office has issued guidance as to the definition of the regulated procedure created by ASPA. It makes specific reference to the definition in section 2(1) and sets out that "pain, suffering, distress and lasting harm" "encompass any material disturbance to normal health (defined as the physical, mental and social well-being of the animal)". It also makes clear that a regulated procedure may consist of "acts of commission (such as dosing or sampling) or of deliberate omission (such as withholding food or water)".
56. Paragraph 2.26 of the guidance deals with recognised veterinary, agricultural or animal husbandry practice. In recognises that:

"Recognised agricultural and husbandry practices (such as castration of farm animals), performed in accordance with other animal welfare legislation and regulations, and being used to manage or conserve the animals, are not regulated procedures unless they are part of a scientific study". (my emphasis)

57. CRD has issued guidance on the impact of the Regulation. Its document issued on 17 February 2012 (Regulatory Update 04/2012) has this to say about recital 40:

"Recital 40 of (the Regulation) refers to (the 1986 Directive), which in turn defines the type of experiments that are covered by the vertebrate data sharing arrangements. On this basis, CRD consider that field monitoring data (e.g. such as that conducted for higher tier bird^[6] and mammal assessments) are not within the scope of the vertebrate data sharing arrangements".

58. The defendant's current Applicant's Guide to the Regulation to be found on its website has exactly the same wording. One of the complaints of the claimant is that, in now taking the view that the Prosser Study is within the scope of vertebrate data sharing arrangements, the defendant is departing from its own guidance.
59. Finally, there are 2 European Commission Guidance Documents which have been issued to give guidance on data sharing under the Regulation. The first is SANCO/12576/2012 (SANCO 2012) and the second is a question and answers document namely SANCO/12415/2013 (SANCO 2013)
60. SANCO 2012 SECTION 2 paragraph 53 onwards deals with what type of vertebrate studies are included in Article 62 of the Regulation. It points out that:

"The question arises which studies are considered "tests and studies involving vertebrate animals"… For example in the case of monitoring of birds and mammals in the fields, it is not very clear whether these constitute "tests and studies involving vertebrate animals"."

61. At paragraph 54 it goes on to state that:

""tests and studies involving vertebrate animals" should be interpreted as experiments within the scope of (the 1986 Directive) regarding the protection of animals used for experimental and other scientific purposes".

62. In paragraph 55 it suggests that the 1986 Directive:

"covers animals used in "experiments" defined as "any use of an animal for experimental or other scientific purposes which may cause it pain, suffering, distress or lasting harm"…"

63. In paragraph 56 it concludes that:

"for monitoring studies, only the studies involving procedure(s) causing a certain level of distress, suffering or lasting harm will be covered".

64. It will be noted from the above that SANCO 2012 talks about monitoring studies and makes clear that only studies involving procedures causing a certain level of distress, suffering or lasting harm will be covered but I do not think that it is disputed that paragraph 56 must be construed purposively to include studies not only causing distress, suffering or harm but which may cause distress, suffering or harm.
65. Mr Heppinstall suggests at paragraph 23 of his skeleton argument that:

"Drawing the above strands together, a study will constitute a VS [vertebrate study] if:

23.1 It is a "regulated procedure" under ASPA…

23.2 A study will constitute a regulated procedure if:

23.3 there is an experimental or other scientific procedure;

23.4 that procedure is applied to a protected animal…[which includes birds]

23.5 that procedure may have the effect of causing that animal pain, suffering distress or lasting harm, being any disturbance to normal health"

66. Of course, it is right to point out that Article 62 does not itself refer to "experiments". It simply talks of "tests and studies".
67. However, in paragraph 68 of his skeleton argument Mr Ward makes it clear that both parties recognise that a bird field monitoring study would only fall within Article 62 if it fell within the definition of a "regulated procedure" set out in section 2(1) of ASPA as interpreted in the light of Article 2 of the 1986 Directive.
68. Finally, by way of background it is right to record that the regulatory framework for the protection of vertebrates provides for the necessity to obtain a licence from the Home Office before any experimental studies are done on vertebrates. No licence was obtained in respect of the Prosser Study because it was not seen as an experiment. It was seen by the claimant and its experts simply as a monitoring exercise rather than an experiment.
69. Indeed, the claimant argues that that was how the defendant saw it. Until 1 April 2015 there was in existence the Food and Environment Research Agency (Fera). Fera was an executive agency of the Department of Environment, Food and Rural Affairs. Since 1 April 2015 it has operated as "Fera Science Ltd", a joint venture between DEFRA and Capita. At the time with which I am concerned however it was a government agency. Mr Tavener makes it clear in his witness statement that Fera did not regard the work involved in the Prosser Study as a regulated procedure for which a licence would be required and so did not report it to the Home Office as a vertebrate study for that purpose, unlike a similar study which was undertaken by Fera on behalf of the claimant on mammals.

The Decision

70. Having set the context, it is right to set out precisely the basis upon which the Defendant argues that the Prosser Study is a vertebrate study subject to the data sharing provisions of Article 62.
71. Since their assertion that it is because "it involves the handling trapping and radio tagging of wild birds unfamiliar with that process" is no longer pursued, the decision rests on the second reason contained in their letter of 29 January 2016 which states:

"In addition, the overall purpose of the study was to determine if metaldehyde kills birds or results in clinical/behavioural effects. The objective has the potential to cause overall suffering and ultimate harm. The symptoms of metaldehyde poisoning in domesticated and wild mammals includes inability to stand, blindness, change in respiratory rate, excessive sweating and salivation, sudden death and seizures. HSE considers that the minimum threshold is also reached in relation to this study which we therefore deem to be in scope of the vertebrate data sharing arrangements as outlined in (the Regulation)".

The Prosser Study

72. In order to understand the arguments, it is necessary to explain briefly what the Prosser Study actually did. The slug pellets were applied to 5 fields. They were applied in the dosage specified for ordinary use and the pellets that were applied were the standard pellets, namely the ones which had been marketed by the claimant for many years under the old authorisation process and still are.
73. The process of application of the pellets was the standard one using standard equipment normally used for the purpose. The fields to which the pellets were applied were standard fields save that

"Where available fields due to be drilled directly (into stubble) or prepared with minimum – tillage methods were selected. Such fields represent a reasonable worst case for slug numbers since the trash from previous crops is not uniformly buried as in inversion ploughing, but mixed with the surface soil or left entirely on the surface, where it provides cover and food for slugs. Therefore such fields would be more likely to receive applications of slug pellets in normal agricultural practice"

74. In short, as the study stated, it "aimed to represent the results of normal agricultural practice in slug pellet application".
75. As regards the birds, the study was undertaken simply on the "free living small farmland birds as present at test sites".
76. In other words, no birds were artificially introduced into the area or removed from it. The birds considered in the study were the birds that would have been there in any event.
77. Of course, the effect of the pellets on the birds had to be observed. That meant mist netting the birds, and then ringing and radio tagging them. As I have said, it is not suggested by the Defendant that this process of netting ringing or tagging in themselves or indeed aggregated was sufficiently distressing or hurtful to make this a vertebrate study.
78. Once the birds had been tagged they were free to go where they wished, either to remain in the area or fly off elsewhere.
79. As Mr Ward effectively summed it up,

"it was a single application of standard pellets using standard equipment at recommended target rates on actual fields likely to receive applications of slug pellets in normal agricultural practice".

Discussion as to unlawfulness/irrationality of the decision

Claimant's submissions

80. Mr Ward argues that this study was simply a harmless monitoring process, it was not an experiment which would make it into a vertebrate study to which the provisions of Article 62 apply. What happened, (namely the spreading of slug pellets, that have been in use for years, on to fields likely to be infested with slugs) is likely to have happened in any event as part of standard agricultural practice. The only distinguishing feature here was that birds were monitored but the birds that were monitored were simply birds that would have been there anyway, of their own volition. And the process of catching, ringing and tagging did not give rise to any procedure which would cause the birds pain or harm, as conceded indeed by the defendant.
81. He reminds me that the 1986 Directive and APSA specifically exclude from the definition of "experiment" non experimental, agricultural or clinical veterinary practices. He also draws attention to the fact that SANCO 2012 distinguishes between monitoring and experiments in its conclusion, at paragraph 56, that only monitoring studies involving procedures causing a certain level of distress suffering lasting harm will come within Article 62.
82. He argues that against that background, and the nature of the study, it is simply irrational to regard the Prosser Study as a vertebrate study in any sense. As he put it in paragraph 80 of his skeleton argument:

"Chiltern's products are already on the market and in widespread use. It is precisely for that reason that the monitoring of their effects is not to be considered "experimental" within the meaning of the test."

83. Mr Ward argues that the defendant's position totally ignores the fact that what was done is likely to have been done in any event. Farmers need to kill the slugs in their fields. Standard agricultural practice would have involved them broadcasting these slug pellets on these fields in any event.
84. He argues that the position of the defendant is thus that what is standard agricultural practice becomes experimental and thus a vertebrate study simply because there was monitoring of this practice on the bird population. He argues that this reduces the definition of vertebrate study to a question of state of mind. If the motive for spreading the pellets is to assess their effect on bird life then it is a vertebrate study, if it is simply for the purpose of killing slugs, it is not. A definition dependent upon motive thus making it a subjective definition is, argues Mr Ward completely absurd.
85. It becomes even more absurd, he argues if one takes that to its logical conclusion. What if Dr Prosser had not arranged for the broadcasting of the pellets but had simply advertised for farmers to let him know when they were going to apply the claimant's slug pellets to one of their fields as part of standard agricultural practice. If Dr Prosser then turned up simply to monitor the effect of that standard agricultural practice on the local bird population, would that too be a vertebrate study? Essentially, he argues that question need only be put and it becomes clear that the position of the defendant is untenable where, as here, what was done in relation to the field would have been done anyway. He argues that the test for whether a study is a vertebrate study or otherwise experimental must be an objective one and not a subjective one based upon the state of the mind of the person carrying out the exercise.
86. Mr Ward argues that at least at one time that appears to have been the view of the Defendant. He argues that one need only recall the matters to which I refer in paragraphs 57 and 58 above to see that that is so.
87. He argues that ordinary agricultural practice and then monitoring does not equal an "experiment/vertebrate study". He argues that the Defendant's conclusion that it does, is adding 2 to 2 and reaching 5.
88. Mr Ward also has particular regard to the fact that ASPA refers to a scientific procedure applied to a protected animal. He argues that these pellets were not applied to the birds at all, nor were they encouraged to consume them. It is different for example to an avoidance study where animals are encouraged to eat the product being tested by, for example, being deprived of food from other sources.
89. He points out that the defendant does not argue that the ordinary use of the pellets in a field amounts to an experimental procedure which is applied to birds. He argues that that would be wholly nonsensical and is specifically why Article 2 of the 1986 Directive expressly makes clear that "non-experimental, agricultural or clinical veterinary practices are excluded" from the definition of an "experiment". He argues that what occurred here is not materially different.
90. In addition, he draws my attention to another dimension of the definition of "experiment" in Article 2(d) of the 1986 Directive. An experiment requires the "use" of an animal for experimental or other scientific purposes. He argues that these birds have not been "used". Standard agricultural practice has been applied to fields which, fortuitously, these particular birds have visited. He argues that that cannot fall with the definition of "use".
91. Mr Ward argues that a purposive definition of vertebrate study must be applied in the construction of Article 62 to take account of the fact that the Regulation itself acknowledges the advantages of the protection of data because it is beneficial to investment and research. He points out that that is specifically made clear in recital 39 and Article 59. He argues that a definition of vertebrate study which includes such harmless monitoring as this is going to discourage this sort of monitoring to the detriment of the wildlife that it aims to protect.
92. Of course, in addition to his assertion of the necessity to apply a purposive definition, he adds the point that it is incumbent upon me in any event to interpret the Regulation narrowly on the basis of the European Court of Justice authorities which I have cited in paragraphs 33 and 34 above. As I have presaged from paragraph 32 above, Mr Ward argues that compulsory sharing of data under Article 62 is an interference with an established proprietary right and so the approach to interpretation has to have, at its heart, the guidance of those authorities.
93. He argues that viewed purposively, the defendant's approach is potentially harmful. It would deter harmless monitoring exercises for fear that, in order to conduct them, the whole panoply of compliance with the regulatory framework would be necessary and, furthermore, there would be the prospect that the time and money spent may not be fully recouped and, even worse, there is the likelihood that results would have to be shared with competitors. Mr Ward argues that that is very likely to deter from being undertaken useful but harmless monitoring such as this. He argues that if a common standard agricultural practice becomes an experimental or other scientific procedure then this will simply minimise the amount of data which is obtained and submitted to the defendant on the effect of existing agricultural practices.
94. In this context Mr Ward refers me to paragraph 2.26 of the Home Office guidance to which I refer in paragraph 56 above and of course the SANCO guidance paragraph 56. He argues that this was monitoring which did not and may not have caused harm. It was monitoring the application of slug pellets as they had been applied for many years under the claimant's existing authorisation.

Defendant's submissions

95. The defendant's position is that the purpose of the study, on the face of the study itself, was to look at:

"the effect on granivorous and omnivorous birds since there may be risks to birds both from directly consuming slug pellets, and from consuming contaminated slugs and other invertebrates".

96. Mr Heppinstall argues that in those circumstances it is clearly a vertebrate study, even on its own terms. It recognises that there may be a risk to birds; if there may be a risk to birds then any study of birds designed to measure that risk is a vertebrate study.
97. As Mr Heppinstall puts it, there is a material difference to field monitoring in the natural environment and applying pellets in the field and then seeing what happens. He draws attention to the observations made in a letter from his instructing solicitors to the claimant's solicitors dated 27 September 2016

"the Study clearly fell within the 1986 and 2010 definition of vertebrate tests. This conclusion is clearly in line with one of the overriding purposes of the (Regulation) which was to minimise the use of vertebrate testing. Further, it is not inconsistent with any of the relevant guidance issued on testing. Any guidance suggesting that field studies generally do not fall within the definition of vertebrate studies is clearly referring to studies in which animals are observed in their natural habitat without the introduction of a potentially dangerous substance which they might well consume".

98. He argues that that is the beginning and end of the case. He argues that it does not matter that no injury was actually caused to the birds. That is not the point. The definition of an experiment constituting a vertebrate study cannot be dependent on the outcome, even an anticipated outcome. Whatever the outcome, it is still an experiment constituting a vertebrate study because it was a study expressed to be for the purpose of "assessing the risks to birds of either consuming the slug pellets or consuming contaminated slugs or other invertebrates".
99. Mr Heppinstall reminds me that Austria, actually the Rapporteur Member State for the active substance metaldehyde, has concluded that studies carried out in materially the same manner as the Prosser Study constitute vertebrate studies. He accepts that that is not binding upon this court, and there is no indication that other Member States have reached the same conclusion, but he argues that judicial comity in the application of the regulations would be desirable.
100. He denies that CRD is acting in a way contrary to its own guidelines in treating this study as a vertebrate study. He argues that the claimant's interpretation of Regulatory Update 04/2012 to which I refer in paragraph 57 above and the guidance on the defendant's website are not sustainable. All that the Regulatory Update and the website guidance make clear is that field monitoring studies are not vertebrate studies as long as one is doing nothing but recording the behaviour of birds and their health in their natural environment. It is not a vertebrate study if you are doing nothing except recording. Here however there is the added dimension of the pellets actually being broadcast in these fields for the purpose of studying their effect on birds. He argues that this clearly engages the provisions of the guidance to ASPA at paragraph 2.26^[7] which does indeed provide an exclusion for recognised agricultural and husbandry practices to provide they are not regulated procedures unless they are part of a scientific study. He argues that the Prosser Study is clearly a scientific study.
101. He points out that the threshold to be crossed here for a study to become an experiment or a vertebrate study is not a high one; it is one that may have the effect of causing the animal pain, suffering distress or lasting harm which in turn is construed as encompassing any material disturbance to normal health (defined as the physical, mental and social well-being of the animal)^[8].
102. He argues that it makes no difference that ASPA makes reference to a scientific procedure being "applied". He argues that it was applied in the circumstances of this case to the local bird population. "Applied" cannot mean physically forcing the pellets down the birds' throats. It simply means that it was a scientific procedure applying to birds, which are protected animals. He argues that these particular birds, fortuitously there on the day of the study, were used for relevant experimental purposes in any ordinary use of that word.
103. He reminds me that re-authorisation is not simply a formality. The rationale for it is that standards to minimise harm to animals have become more stringent over the years. Just because the claimant's products have been authorised hitherto does not mean that they would qualify for re-authorisation. Mr Heppinstall argues that the Prosser Study is necessary as part of the claimant's effort to obtain the reauthorisation that is vital to it and is to measure the risk of harm to birds in the context of more stringent standards and so is inevitably a vertebrate study.
104. Mr Heppinstall reminds me that the claimant has conceded that if its product had a new formulation then spreading it in a field and monitoring its effect on vertebrate wildlife would be a vertebrate study. He argues that the fact that this is a product which has been in use for years does not create a basis for distinguishing this test. The test was done to assess the risk to vertebrates in the light of the increased stringency and to provide data on that. Any study, he argues, to assess whether an old formulation meets a new test which involves considering its effect on the bird population is a vertebrate study. He argues that a test on the old formulation to see that it meets the standards of a new threshold is no different in principle to the test of a new formulation to see if it meets the standards of a new threshold.
105. Mr Heppinstall recognises the importance placed by the Regulation on data protection. As I have said however, he does not concede that Article 62 is a derogation from that protection. He sees the Regulation is creating 2 competing fundamental principles by which in fact the rights given to vertebrates not to be tested trump proprietary rights. In other words, the rights for vertebrates not to be tested are more important than the commercial value of any data.

Conclusions

106. Let me first deal with the issue about whether Article 62 is a derogation from a general principle. In my view Mr Ward's arguments are the more persuasive.
107. It seems to me that the answer lies in the wording of Article 59 which provides for the general principle of data protection in respect of studies. The fact that Article 62 is a derogation from that principle is clear from the wording of Article 59 which provides that a report is data protected "except as provided in paragraph 2 of this Article, in Article 62 or in Article 80". Article 62 is therefore, on the face of the Regulation, an exception from, and therefore a derogation from, a principle. In my view therefore I am obliged under the European authorities to which I have earlier referred to interpret Article 62 strictly. Of course even though that is so, it does not necessarily mean that what occurred here is not a vertebrate study, on a true construction of Article 62.
108. Having said that and bearing in mind that the parties are agreed that the Prosser Study is only a vertebrate study under Article 62 if it is a "regulated procedure" under ASPA and an "experiment" under the 1986 Directive, it is right to note that, at paragraph 75 of his skeleton argument, Mr Ward recognises that had the study tested a new formulation of a product which had yet to be authorised then this would have been a vertebrate study. It seems to me that if he accepts that in such a situation the pellets would have been applied to the birds and the birds were being used in such a way as to bring them within the definition of experiment in Article 2 of the 1986 Directive or s2 ASPA that it is difficult to designate a separate meaning to application and use in the context of the Prosser Study just because it involved pellets that were not new.
109. In both cases the pellets would simply have been distributed over the field and the birds who fortuitously happened to be there would no doubt have behaved in the same way. The application and the use in each case are equally passive but if it is application and use in one scenario, it is difficult to see how it is not application and use in the other as well. The question therefore really is not whether the study applied to or used birds but whether the study itself was an experiment or, to put it another way, an experimental or other scientific procedure.
110. The point that Mr Ward consistently made was that what was involved here was actually a standard agricultural practice that would have been carried out in any event and that the regulatory framework recognises that standard agricultural practices are excluded from the definition of experiments or scientific procedures. It was, he argues merely monitoring an existing product and that the regulatory framework itself distinguishes between monitoring on the one hand and experimenting on the other^[9]. He accepted my proposition that, while all experiments might involve monitoring, not all monitoring involved an experiment. The answer to the question of when monitoring becomes an experiment might be difficult to answer but it is not at the point where what is done is simply normal agricultural practice^[10].
111. I recognise that SANCO 2012 paragraph 56 specifically mentions monitoring studies and makes it clear that only those causing a certain level of distress, suffering or lasting harm will be vertebrate studies for the purposes of Article 62. The restriction to studies that actually cause distress was not repeated in ASPA which talks about procedures which may have the effect of causing pain, suffering and distress and, as I have said above, I do not think that it is disputed that paragraph 56 of SANCO itself must be construed to include studies not only causing distress but which may cause distress. It is a fact that metaldehyde can cause distress and suffering and even death to vertebrates^[11].
112. Of course, it is entirely true that it is part of standard agricultural practice that slug pellets are broadcast over fields at certain times of the year and I accept that in this case the slug pellets may well have been applied in any event. I am also prepared to work on the assumption that in fact the bird population was not caused distress or suffering as result of this exercise. I remind myself that Mr Ward suggested that 700,000 hectares of land benefited from the application of the claimant's pellets each year and that the risk to birds on this occasion was exactly the same whether anybody was there to monitor the effect on them or not.
113. The fact is however that in this case there was a specific reason why these slug pellets were broadcast over these particular fields. In fact it was not in pursuance of standard agricultural practice. It bears repeating that it was, according to the stated "Purpose and Objective" set out in the Introduction to the Prosser Study itself to accumulate "further data on the effect on granivorous and omnivorous birds… since there may be risks to birds both from directly consuming slug pellets and from consuming contaminated slugs and other invertebrates". The reference to risks to birds is in itself, in my opinion, an acknowledgement of the risk of distress and suffering to birds.
114. The risk that the Prosser Study was designed to obtain data about was the risk to birds of distress and suffering caused by these pellets. That was the reason that these pellets were distributed on these particular dates in these particular fields. It is right that these pellets may have been distributed on these particular fields for the purpose of killing slugs in accordance with standard agricultural practice but on this occasion the purpose was to see what effect these pellets would have on the local bird population. I should add, for the reasons contained in paragraphs 64 and 111 and elsewhere, that it cannot matter that the birds were not in actual fact caused distress if there was a risk that they might have been. And of course the Prosser Study recognises that there "may be risks".
115. I understand Mr Ward's point that if the definition of vertebrate study depends simply upon the question of motive then it becomes unwieldy and unsatisfactory. That is often because it is difficult to discern somebody's real motive from their professed motive. But here we have it in black and white what the motive was. It is in the Introduction to the Prosser Study.
116. Mr Ward suggests that Mr Heppinstall had no real answer to whether there would be a vertebrate study if Dr Prosser had not arranged himself for the pellets to be distributed but had simply asked a farmer if he could monitor wildlife after the farmer had applied the pellets as directed for the purpose of killing slugs in his field. It is the issue which I identify in paragraph 85 above.
117. The difficulty Mr Ward faces is that that is not the situation with which I am faced. We know that in this case the pellets were distributed under the auspices of a scientist to assess the risk of the pellets on birds. The fact that the construction of the Regulation may give rise to the possibility of it being circumvented by some possibly imaginative thinking is not a basis for construing the Regulation other than in accordance with its actual meaning.
118. I can well understand the irritation of the claimant who when reading the Regulatory Update 04/2012 would be forgiven for taking the view that the defendant was not likely to consider this exercise as within the scope of Article 62. However, it must be said that, if that update is read in conjunction with the Home Office guidance on ASPA, the view may have been taken that the Update is more nuanced, bearing in mind that the guidance on ASPA only excludes recognised agricultural practices from the definition of regulated procedures where they are not part of a scientific study.
119. In the end and at its most fundamental I have to say that I do not see how the Prosser Study can be seen as anything other than a scientific study of the birds. It is after all a study of the effect (if any) of the pellets on birds conducted under the supervision of a scientist, which was monitored by a scientist and which contains a Statement of Compliance with Good Laboratory Practice.
120. I should say that I do not overlook the need argued by Mr Ward to apply a purposive definition which would exclude this study from the effect of Article 62. I have to say however that it is difficult to see how a finding that this particular study was a vertebrate study is likely to deter others from conducting the same sort of exercise as that conducted by the claimant or that my finding that the Prosser Study was a vertebrate study will produce an effect entirely contrary to the purpose of the Regulation, as Mr Ward asserts in paragraph 79 of his skeleton argument. It may mean that anybody undertaking an exercise of this sort may have to obtain a licence to undertake the study and may then have their data ultimately shared but if information such as this is necessary for the purpose of obtaining authorisation or re-authorisation then it will have to be obtained. It may be that at some time in the future the claimant might itself benefit from that.
121. In all the circumstances, and for the reasons set out, I do not find myself in a position to find that the decision of the defendant, who, after all, has some expertise in this field, to be an irrational one when it concluded that the overall purpose of the study was "to determine if metaldehyde kills birds or results in clinical/behavioural effects." And that that made it a vertebrate study susceptible to the provisions of Article 62.
122. Nor do I find the Defendant's construction of Article 62 as extending to this particular study to be unlawful on a true construction of that Article, taking account of the regulatory framework and in particular the meaning of a regulated procedure under ASPA and an experiment under the 1986 Directive.
123. I am accordingly satisfied that, even though this product has been used for years without apparent mishap so far as the wildlife population is concerned, the Prosser Study was a vertebrate study subject to the data sharing provisions of Article 62. Thus, the claim falls to be dismissed.
124. Having said that, I have to say that I am puzzled as to how this study will benefit competitors bearing in mind that this was a study of what I am told is an entirely unique product in terms of the concentrations of metaldehyde but that of course is not the issue before me.
125. I should say finally for completeness, that the fact that Austria appears to have come to the conclusion that this sort of study is a vertebrate study has not influenced my decision but I do of course recognise that, at least for the next couple of years, it may be unsatisfactory and contrary to the harmonisation process, if different Member States took different views as to what constitutes such a study.

Final Remarks

I am grateful to counsel for their very able assistance in this matter.

HHJ Saffman

Note 1   Which it is accepted applies albeit that it was later superseded by Directive 2010/63/EU (the 2010 Directive). In any event it is common ground that there would be no material difference in outcome in this case even if the 2010 Directive applied.    [Back]

Note 2   I emphasise the reference to "costs" of producing it. The position of the claimant is that an assessment of cost in this context takes account only of actual costs incurred but takes no account of the actual value of the research to others. There is clearly a difference between "cost" and "value". A, for example, may own a strip of land which he acquired for very little but if it provides a means of access to the land ripe for development owned by B, a property developer its value to B can considerably exceed the cost to which A was put in acquiring the land.    [Back]

Note 3   by Commission Implementing Directive 2011/54/EU    [Back]

Note 4   In fact the 1986 Directive has been superseded by Directive 2010/63/EU (the 2010 Directive) that was transposed into domestic law by amending ASPA but the parties are agreed that the court is required to apply the old regime under the original unamended ASPA and the 1986 Directive because the 2010 Directive only applies to experiments conducted after 1 January 2013. In fact, as I understand it, it is common ground that the outcome is the same under both regimes.    [Back]

Note 5   In its decision letter the defendant cited as one of its reasons for taking the view that this study was a vertebrate study was that "HSE considers that as the study involved wild birds that are unfamiliar with handling, trapping and radio tagging (pheasants/sparrows) this may cause pain suffering distress or lasting harm equivalent to, or higher than, that caused by the introduction of the needle in accordance with good veterinary practice" that ground is not now relied upon presumably on the basis that it is unsustainable in the light of section 2(5). Furthermore, in fact the phraseology of that particular reason appears to have had in mind the 2010 Directive rather than the 1986 Directive with which I am concerned (see footnote 3 above).    [Back]

Note 6   The Prosser Study is a higher tier bird assessment.    [Back]

Note 7   See para 56 above.    [Back]

Note 8   See paragraph 55 above. In addition it should be noted that it does not appear to be in dispute that sufficient concentrations of metaldehyde can have a deleterious, and even a fatal, effect on vertebrates. That is why it was initially included in Annex 1 of the Directive. The Commission Implementing Directive 2011 makes it clear that in its overall assessment of metaldehyde, Member States shall pay particular attention to the acute risk and long-term risk to birds and mammals.    [Back]

Note 9   SANCO 2012 paragraph 56.    [Back]

Note 10   Even involving the tagging of birds because that process is specifically excluded.    [Back]

Note 11   See para 71 above.    [Back]