Nutricia Ltd, R (on the application of) v The Secretary of State for Health [2015] EWHC 2285 (Admin) (31 July 2015)

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Cite as: [2015] EWHC 2285 (Admin)

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		Neutral Citation Number: [2015] EWHC 2285 (Admin)
		Case No: CO/5151/2014

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

Royal Courts of Justice
Strand, London, WC2A 2LL

31/07/2015

B e f o r e :

MR JUSTICE GREEN
____________________

Between:

	The Queen on the application of Nutricia Limited	Claimant
	- and -
	The Secretary of State for Health	Defendant

____________________

Thomas de la Mare QC and Simon Antrobus (instructed by DWF LLP) for the Claimant
Andrew Henshaw QC (instructed by Treasury Solicitor) for the Defendant
Hearing dates: 3rd - 4th June and 7th July 2015
____________________

HTML VERSION OF JUDGMENT
____________________

INDEX

A. Introduction, issues and conclusion 1-21

(i) Introduction 1-12

(ii) Issues 13-18

(iii) Conclusions 19-21

B. Legislative Framework 22-69

(i) The four categories of product 22

(ii) Fortified foods 23-24

(iii) Food supplements 25-27

(iv) PARNUTS 28-38

(v) Foods for Special Medical Purposes 39-69

(a) The FSMP Directive 39-47

(b) Guidance provided by the Defendant on FSMPs 48-52

(c) The Medical Food (England) Regulations 2000 – "MFER" 53-64

(d) The new regime – Regulation (EU) 609/2013: 12th June 2013 65-69

C. Relevant facts 70-101

(i) Souvenaid 71-72

(ii) The notification of Souvenaid to the Defendant 73

(iii) The Defendant's concerns as to whether Souvenaid was an FSMP 74-76

(iv) The Advisory Committee on Borderline Substances ("ACBS") 77-86

(v) The discussions at EU level 87

(vi) The First Decision: 23rd September 2013 88-92

(vii) The EU Standing Committee meeting: 10th February 2014 93-96

(viii) The instruction of Dr Dangour 97-99

(ix) The Final Decision 100-101

D. Issue I: Did the Department of Health have the power to take the Final Decision? 102-138

(i) The issue 102-105

(ii) Analysis of Final Decision 106-111

(iii) Conclusions 112

(a) The Final Decision was intra vires 112-113

(b) The Marleasing approach to interpretation 114-119

(c) The limits of the Marleasing approach 120

(d) The mechanics of implementation: The choice of "form and method" 121-125

(e) The application of the Marleasing principle to the MFER 126-138

E. Issue II: Did the experts relied upon by the Department of Health have the relevant competence and expertise? 139-154

(i) The issue as articulated by the Claimant 139-140

(ii) The facts relevant to the issue 141-145

(iii) The extent to which the issue is properly justiciable/conclusions 146-154

F. Issue III: Did the Department of Health act perversely or irrationally in rejecting the evidence of the Claimant? 155-179

(i) The provisional nature of the issue 155

(ii) The scope and nature of the review process 156-164

(iii) The intake point 165-175

(iv) The modification point 176-179

G. Issue IV: Does the Final Decision amount to a breach of Article 34 TFEU? 180-208

(i) Articles 34 and 36 TFEU 180-185

(ii) Claimant's submissions 186-193

(iii) Analysis: Nutricia's formal case 194-197

(iv) The new case: Alleged delay in processing Drug Tariff decisions 198-208

H. Questions for reference to the Court of Justice 209-223

(i) Questions to be referred 209

(ii) The reasons for reference 210-214

(iii) The difference in overall approach: objective or subjective? 215-217

(iv) Questions relating to the size of the relevant patient group 218

(v) The intake point 219

(vi) The modification point 220-223

I. Conclusion 224-225

Mr Justice Green:

A. Introduction, issues and conclusion

(i) Introduction

There is before the Court an application for permission to apply for judicial review and, if granted, the substantive judicial review in a complex case concerning a decision adopted by the Defendant which expressed the "view" that a yoghurt style food product called "Souvenaid" produced by Nutricia Limited ("Nutricia" or the "Claimant") could not be classified as a food for special medical purposes or "FSMP". I indicated during the hearing that this was a case in which it was appropriate to grant permission and the case thus proceeds as the substantive application for judicial review.

Over recent years there have evolved a range of regulatory regimes which seek to govern how different foods are marketed and as to the nutritional and/or medical claims that may be made for them. Manufacturers increasingly produce foods which are formulated to act as dietary supplements or which are basic foods fortified with minerals or which are designed to address particular medical problems. A well known example is gluten free bread for those with some degree of gluten intolerance.

The product in issue in this case, Souvenaid, is a 1kcal/ml, vanilla or strawberry flavoured, milk-based drink containing Omega 3 fatty acids, Uridine, Choline and a range of vitamins and minerals. It is formulated to address the apparent special nutrient requirements for those diagnosed with early Alzheimer's disease ("AD").

The rules relating to the marketing (which include labelling) of foods for medical purposes are found in a specific EU directive on FSMP. This is Commission Directive 1991/21/EC upon dietary foods for special medical purposes (the "FSMP Directive").

This regime is unlike, say, the regime regulating the placing on the market or advertising of medicines, which requires prior authorisation. The FSMP Directive is more relaxed reflecting the fact that FSMP products are essentially safe and can be used as foods. Under the FSMP Directive the responsibility for determining whether a product complies with the rules resides in the first instance with the manufacturer or seller. The FSMP Directive prohibits the sale of non-compliant products; and in the UK the risk of non-compliance carries with it the risk of prosecution.

It is not necessary for the purposes of this judgment to set out in any detail the commercial considerations which underpin a producer's desire to market a product as an FSMP, as opposed to an ordinary food. Very broadly, if a food is an FSMP it entitles the producer to make certain claims about the food which may be valuable in enabling the product to reach a specialised medical market. There are also perceived to be advantages in relation to the rules relating to drug tariffs and reimbursement (the "Drug Tariff"). It follows that decisions made about the classification of a product as falling (or not) within the various regulatory regimes may have wide ranging commercial implications.

Under the FSMP Directive Competent Authorities in the Member States are required to conduct "efficient official monitoring" of the requirements in the directive. These requirements cover such matters as the name of the product, and the information that must be included on labels. It also imposes a duty on producers to notify the Competent Authorities of their plans to sell an FSMP upon first marketing and it requires Member States to prohibit marketing of products which have not been so notified.

In England the FSMP Directive has been implemented by regulations adopted under the Food Safety Act 1990 ("FSA 1990"). These can, without the risk of any party in this litigation disagreeing, be described as most unsatisfactory. The FSMP Directive is a "framework" measure i.e. one which describes a broad framework of rules that then needs to be filled in by the Member States when performing their duty to implement the measure into national law. However, in the present case rather than systematically draft out the scheme that needed to be put into place the legislature has adopted a variety of piecemeal devices. First, the regulations operate in large measure by cross reference to the Directive and assume necessarily that those provisions cross referred to are applicable without more; secondly, the regulations refer to a series of provisions in the FSA 1990 and then provide that they also apply by cross-reference, mutatis mutandis, to the implementing regulations. Thirdly, the regulations introduce a number of provisions which define a small number of key terms, introduce a restriction on sale for non-compliant products and introduce a criminal sanction for violation. The implementing regulations thus have to be read in the context of both the FSMP Directive and the FSA 1990. Additional guidance is provided by the promulgation by the Defendant of non-statutory Guidance Notes.

The net effect is that there is no single coherent source of rules and information for those subject to the regime.

In 2012 Nutricia notified the Defendant, who is the Competent Authority under the FSMP Directive, of the details of Souvenaid and it claimed that it was an FSMP. There followed a relatively lengthy process during which the Defendant assessed information provided to it by Nutricia and consulted with other Member States within the EU and with the Commission.

The Defendant also referred the issue to the Advisory Committee on Borderline Substances ("ACBS"). This committee is an ad hoc body and has no separate or statutory underpinning or authority. It exists to provide advice to the Defendant in particular in relation to how the Defendant should classify "borderline" products which fall under the Drug Tariff and for related reimbursement purposes. The ACBS however considered that to provide full advice it needed the Defendant to determine the proper classification of Souvenaid, including whether it was an FSMP. Accordingly, the committee did not progress its deliberations and as of the date of this judgment it has not provided any final advice to the Defendant in relation to Drug Tariff issues.

Ultimately, the Defendant concluded that Souvenaid was not an FSMP. In August 2014 the Defendant sent a letter addressed to Nutricia in which it set out its conclusion that, for various technical reasons, Souvenaid was not an FSMP. It also expressed its position that, as such, Nutricia should cease selling Souvenaid with claims which assumed that Souvenaid was an FSMP. This disagreement has led to the present litigation. This letter, which constitutes the decision being challenged, identified two discrete reasons. First, that Nutricia had not established in its evidence that Souvenaid met a "special nutritional" requirement. Secondly, that Nutricia had failed to establish that even if Souvenaid met a "special nutritional" requirement, a patient's needs could not be met by modification of the patient's diet for instance by the introduction of food supplements. In this judgment I refer to these two reasons as "the intake point" and "the modification point".

(ii) Issues

I have grouped the issues arising under five heads:

Issue I – The power of the Defendant to adopt decisions: The Claimant submits that the regulations adopted under the FSA 1990 in order to implement the FSMP Directive were inadequate to the extent that they conferred no express power on the Defendant to take any decision, as part of monitoring, on the applicability of the FSMP rules to Souvenaid. Indeed, the regulations do not even confer upon the Defendant any power to monitor at all even though the FSMP Directive requires Competent Authorities to conduct effective monitoring of the rules. The Claimant thus says that the Defendant in adopting a decision on the classification of Souvenaid has acted ultra vires. This raises a question about how national courts are to construe national measures which implement EU directives and/or are within the field of operation of the EU directive in question.

Issue II – The reliance by the Defendant upon the expertise and competence of experts instructed to advise: The Claimant submits that the Defendant, in undertaking a technical and scientific evaluation of Souvenaid, has acted perversely and irrationally in accepting the advice from expert nutritionists who lacked the basic clinical competence to assess Souvenaid against the test laid down in the Directive for an FSMP.

Issue III: The Claimant submits that the Defendant (a) applied the wrong test in law and/or (b) acted perversely and irrationally in not accepting and/or giving adequate weight to pre-clinical and clinical evidence submitted by Nutricia relating to the medical benefits and efficacy of Souvenaid. Two particular issues are raised which focus upon the "intake point" and the "modification point".

Issue IV: The Claimant's submission that the Defendant's decision is in breach of Article 34 TFEU which prohibits quantitative restrictions upon imports.

The questions to be referred to the Court of Justice - In section H of this judgment I describe the context to the questions of law that I consider should be referred to the Court of Justice. The questions referred are set out in the Order which is the Schedule to this judgment.

(iii) Conclusions

I conclude that the Defendant acted within its powers in adopting the challenged decision (Issue I). I also accept that the Defendant acted lawfully in relying upon the experts instructed to provide advice (Issue II). Further, I reject the submission that the Defendant acted unlawfully under Article 34 TFEU (Issue IV).

With regard to the issues of construction and interpretation arising out of Issue III, I have decided that the Defendant is correct but only upon the assumption that the test he applied was correct in law. As to the legal issues inherent in that assumption I have concluded they should be referred to the Court of Justice of the European Community. There is real doubt as to the meaning of an "FSMP"; the definition is very broad and in many respects imprecise. It incorporates components the practical operation of which are susceptible to a number of differing interpretations. There is also evidence that differing views are held by different Competent Authorities across the EU. Mr Henshaw QC, for the Secretary of State, indicated that there was no opposition to the Claimant's submission that questions should be referred. The answers to these questions could affect the assessment which the Defendant made about Souvenaid and are therefore necessary to enable the High Court to give a final ruling on the central issues arising. There are other reasons why I have concluded that a reference of these points is necessary which relate to the importance of the issues and the desirability of a common approach being applied across the EU which will afford greater and more consistent guidance both to Competent Authorities and to producers of FSMP products: see Section H. below at paragraphs [209] – [223].

The effect of the decisions that I have made is that unless the Defendant adopted an incorrect approach in law to the assessment of the evidence relating to Souvenaid the application for judicial review will fail. However, if the law is not as was applied by the Defendant then in the light of the answers given by the Court of Justice an assessment will have to be made of whether any errors were material to that assessment and if they were then the decision may have to be quashed and remitted. In all likelihood, if this were to occur, the responsibility for ruling upon the issue would then fall to the EC Commission under new rules which have been adopted which are not at present in force but will be so by the time the Court of Justice rules.

B. Legislative framework

(i) The four categories of product

I turn now to the relevant legislative framework. Under both EU and domestic law products intended to provide some form of nutritional supplementation to the human diet fall into four broad categories: fortified foods; food supplements; foods for particular nutritional uses (known as "PARNUTs"); and foods for special medical purposes ("FSMPs"). Each category is subject to a distinct regulatory framework.

(ii) Fortified foods

"Fortified foods" are governed by Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods ('the Fortified Foods Regulation'). These define certain circumstances in which vitamins and minerals may be added to foods intended, under normal circumstances, to provide all necessary nutrients for "normal development and maintenance of a healthy life" (Recital 7). These include situations where there are demonstrable nutritional deficiencies attributable to the "socio-economic situation prevailing in the Community and the life styles of different groups of the population" (Recital 8). The Fortified Foods Regulation is aimed at healthy eaters and applies without prejudice to specific provisions provided in other EU legislation concerning:

"… foods for particular nutritional uses and, in the absence of specific provisions, compositional requirements of such products rendered necessary by the particular nutritional requirements of the persons for whom they are intended".

(Article 1(3)(a)).

Typical fortified foods include breakfast cereals with added vitamins and minerals.

(iii) Food supplements

These are governed by the terms of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 ("the Food Supplements Directive"). These govern those foodstuffs supplementing the normal diet, to provide all necessary nutrients for "normal development and maintenance of a healthy life" (Recital 3). The Food Supplements Directive, like the Fortified Foods Regulation, is also aimed at healthy eaters and accordingly the definition of a "food supplement" in Article 2(a) of the Food Supplements Directive reads as follows:

"…foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities".

One aspect of the dispute between the parties in this case concerns the view of the Defendant that Souvenaid may be either (a) a food supplement and/or (b) a fortified food and should therefore be marketed as such; but is not (c) an FSMP.

The Food Supplements (England) Regulations 2003 implement the Food Supplement Directive into English law. They are enforced by local authorities ("food authorities").

(iv) PARNUTS

Food products for "particular nutritional uses" or, as they are known, "PARNUTS" are foodstuffs which are "clearly distinguishable from foodstuffs for normal consumption". These are suitable for certain specified nutritional purposes "owing to their special composition or manufacturing process".

PARNUTS were originally regulated pursuant to Council Directive 89/393/EEC of 3^rd May 1989 ("Directive 89/393/EEC"). This directive has now been replaced (see below); but it still has resonance because it was pursuant to Article 4(1) thereof that the FSMP Directive (set out below) was adopted in March 1999. Article 4(1) provided that for the products listed in Annex 1 to the directive (which included "dietary foods for special medical purposes") "specific" directives should be adopted (by the Commission in accordance with the procedure laid down in Article 13) which could address in particular:

"(a) essential requirements as to the nature or composition of the products;

(b) provisions regarding the quality of raw materials;

(c) hygiene requirements;

(d) permitted changes within the meaning of Article 3 (2);

(e) a list of additives;

(f) provisions regarding labelling, presentation and advertising;

(g) sampling procedures and methods of analysis necessary for checking compliance with the requirements of the specific Directives".

The directive was transposed into domestic law by the Notification of Marketing of Food for Particular Nutritional Uses (England) Regulations 2007. Article 1(2) of the directive defines foodstuffs for particular nutritional uses as:

"…foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability".

The directive goes on to state in the same article that a "particular nutritional use" shall "fulfil the particular nutritional requirements":

"(a) of certain categories of persons whose digestive processes or metabolism are disturbed; or

(b) of certain categories of persons who are in a special physiological condition and who are therefore able to obtain special benefit from controlled consumption of certain substances in foodstuffs; or

(c) of infants or young children in good health".

It is worth pointing out that in the recitals to this directive it is explained that one of the purposes of the monitoring obligation which is imposed upon the competent authorities of the Member States is "to check whether a foodstuff actually has the particular nutritional properties attributed to it" (Recital 6).

Directive 89/398/EEC was replaced by Directive 2009/39/EC of 6^th May 2009 of the European Parliament and of the Council of 6^th May 2009 on foodstuffs intended for particular nutritional uses ("the PARNUTS Directive"). This contains comparable recitals relating to monitoring:

"(5) Although foodstuffs intended for particular nutritional uses which are the subject of specific provisions can be efficiently monitored on the basis of the general rules for monitoring all types of foodstuffs, this is not always the case for those foodstuffs in respect of which no such specific provisions exist.

(6) For the latter the usual means available to the monitoring bodies might not, in certain cases, enable them to check whether a foodstuff actually has the particular nutritional properties attributed to it. It is necessary, therefore, to provide that, where necessary, the person responsible for placing that foodstuff on the market should assist the monitoring body in carrying out its activities.

(7) Specific provisions applicable to certain groups of foodstuffs should be laid down by means of specific Directives".

Article 13(1) of the PARNUTS Directive, which is relied upon by the Claimant, provides:

"Where a Member State has detailed grounds for establishing that a foodstuff intended for a particular nutritional use which does not belong to one of the groups listed in Annex I does not comply with Article 1(2) and (3) or endangers human health, albeit freely circulating in one or more Member States, that Member State may temporarily suspend or restrict trade in that product within its territory. It shall immediately inform the Commission and the other Member States thereof and give reasons for its decision".

As set out above Article 13 power is reserved for those PARNUTS which are not contained in the groups listed in Annex I to the directive. As with its predecessor Annex I comprises PARNUTS for which provision is to be made in separate directives, namely: FSMPs; infant formulae and follow-on formulae; processed cereal-based foods and baby foods for infants and young children; food intended for use in energy-restricted diets for weight reduction; and foods intended to meet the expenditure of intense muscular effort (especially for sportsmen).

The Claimant submits that the power under Article 13(1) of the PARNUTS Directive is merely provisional. Once exercised by a Member State, Article 13(2) makes it plain that it is for the Commission, having consulted all other affected Member States (i.e. those in which the PARNUT is sold), to decide whether or not the food should be withdrawn. The Member State's power under Article 13(1) is thus a mere precursor to an authoritative and centralised decision by the Commission.

The PARNUTS Directive is transposed into domestic law in this country by the Notification of Marketing for Food for Particular Nutritional Uses (England) Regulations 2007, and Regulation 4 expresses the Article 13 power in the following terms:

"4.— Declaration

(1) Where the Agency has detailed grounds for establishing that a foodstuff intended for a particular nutritional use which does not belong to one of the groups listed in Annex I to [the PARNUTS Directive] does not comply with Article 1(2) and (3) of [the PARNUTS Directive] or endangers human health, it may by written declaration suspend or restrict trade in that product.

(2) Such a declaration shall be published in such manner as the Agency thinks fit and shall specify the product concerned.

(3) A declaration which imposes conditions on trade in any product shall specify those conditions.

(4) Where a declaration is in force suspending trade in any product, no person shall trade in that product.

(5) Where a declaration is in force imposing conditions on trade in any product, no person shall trade in that product unless the product complies with conditions specified in the declaration.

(6) A declaration may be modified, suspended or revoked by a further written declaration published, so far as is practicable, in the same manner and to the same extent as the original declaration".

No such power of temporary suspension exists for the product categories listed in Annex I of the PARNUTS Directive (such as FSMP), which are subject to their own dedicated legislation.

(v) Foods for special medical purposes – "FSMP"

(a) The FSMP Directive

Foods for special medical purposes are regulated separately under Commission Directive 1999/21/EC upon dietary foods for special medical purposes - "the FSMP Directive". As observed above the FSMP Directive was adopted pursuant to an exercise of express legislative powers under Directive 89/398/EC. It is common ground therefore that FSMPs are a subset of PARNUTS but they are nonetheless subject to their own particular regulatory regime. The FSMP Directive thus regulates the subset of PARNUTS referred to in recital 1 to the FSMP Directive viz: "dietary foods for special medical purposes… intended to meet the particular nutritional requirements of persons affected by or malnourished because of a specific disease, disorder or medical condition; whereas for this reason they must be used under medical supervision…".

Recitals 1-10 of the FSMP Directive set out its purpose and, as such, they are relevant to the interpretation of the substantive provisions of the directive:

"(1) Whereas dietary foods for special medical purposes are intended to meet the particular nutritional requirements of persons affected by or malnourished because of a specific disease, disorder or medical condition; whereas for this reason they must be used under medical supervision which may be applied with the assistance of other competent health professionals;

(2) Whereas such foods are numerous and their composition may differ substantially depending on the specific disease, disorder or medical condition of the patients for whom they are intended, the age of the patients and the place in which they receive health care support, on whether the foods are intended to be used as the sole source of nourishment or not, and possibly on other factors;

(3) Whereas, because of the wide diversity of such foods and the rapidly evolving scientific knowledge on which they are based, it is not appropriate to lay down detailed compositional rules;

(4) Whereas, however, some basic rules concerning vitamin and mineral substances content can be laid down for products considered to be nutritionally complete for covering the particular nutritional requirements of the intended user; whereas such rules for nutritionally incomplete foods can be laid down only for the maximum levels of these substances as appropriate;

(5) Whereas this Directive reflects current knowledge about those products; whereas any modification to allow for innovation based on scientific and technical progress will be decided in accordance with the procedure laid down in Article 13 of Directive 89/398/EEC;

(6) Whereas pursuant to Article 4(2) of Directive 89/398/EEC, the provisions relating to the substances with specific nutritional purposes to be used in the manufacture of foods for special medical purposes should be laid down in a separate Commission directive;

(7) Whereas pursuant to Article 7 of Directive 89/398/EEC, the products covered by that Directive are subject to the general rules laid down by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (3), as last amended by Commission Directive 1999/10/EC (4); whereas the present Directive adopts and expands upon the additions and exceptions to those general rules, where appropriate;

(8) Whereas, in particular, in view of the nature and destination of dietary foods for special medical purposes, it is necessary to provide information concerning the energy value and principal nutrients contained in such foods;

(9) Whereas, given the particular nature of dietary foods for special medical purposes, additional means to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products;

(10) Whereas, in accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of approximating the laws of the Member States relating to foodstuffs intended for particular nutritional uses to lay down rules on foods for special medical purposes; whereas this Directive confines itself to what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 3b of the Treaty.

The definition of an FSMP is set out in Article 1(2)(b) of the FSMP Directive, as follows:

"dietary foods for special medical purposes' means a category of foods for particular nutritional uses specially processed or formulated and intended for the dietary management of patients and to be used under medical supervision. They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two".

Article 2 of the FSMP Directive imposes an express duty on Member States to enforce the rules. It is, in my judgment, clear that this would include ensuring that food products are properly classified. The Article provides as follows:

"Member States shall ensure that dietary foods for special medical purposes may be marketed within the Community only if they comply with the rules laid down in this Directive".

The suitability of FSMP for their dietary purpose is covered by Article 3 of the FSMP Directive which prays in aid both nutritional and medical principles and the notion of "generally accepted scientific data":

"The formulation of dietary foods for special medical purposes shall be based on sound medical and nutritional principles. Their use, in accordance with the manufacturer's instructions, shall be safe and beneficial and effective in meeting the particular nutritional requirements of the persons for whom they are intended, as demonstrated by generally accepted scientific data. They must comply with the compositional criteria specified in the Annex".

Article 4 lays down rules governing such matters as: (i) the collective name for FSMP products; (ii) labelling requirements and the duty to specify energy values, average quantities of mineral components, protein, carbohydrate, fat and other nutrients contents, information on osmolality or osmolarity; (iii) information on the origin and the nature of the protein and/or protein hydrolysates: (iv) relevant medical notices and hazard warnings; (v) instructions for use.

Article 5 of the FSMP Directive makes it clear that Member States, as part of their Article 2 duty to ensure compliance, must provide for a notification procedure to facilitate "efficient monitoring" of FSMPs. It is in the following terms:

"1. To facilitate efficient official monitoring of dietary foods for special medical purposes, when a product is placed on the market, the manufacturer, or where a product is manufactured in a third country, the importer, shall notify the competent authority of the Member States where the product is being marketed by forwarding to it a model of the label used for the product. Member States may, if they can demonstrate that notification is not necessary in order to monitor those products efficiently in their territory, not impose that obligation.

2. The competent authorities within the meaning of this Article are those referred to in Article 9(4) of Directive 89/398/EC".

Under Article 9(4) of Directive 89/398/EC Member States were required to notify to the Commission the identity of the relevant Competent Authorities. The United Kingdom duly notified the Defendant as the competent authority for England.

This notification procedure for FSMP may be compared with that required for PARNUT under Article 11 of the PARNUTS Directive (which excludes FSMP from its ambit). For ease of reference Article 11 provides:

"1. To permit efficient official monitoring of foodstuffs intended for a particular nutritional use which do not belong to one of the groups listed in Annex I, the following specific provisions shall apply:

(a) when a product as referred to above is placed on the market for the first time the manufacturer or, where a product is manufactured in a third State, the importer, shall notify the competent authority of the Member State where the product is being marketed by forwarding it a model of the label used for the product;

(b) where the same product is subsequently placed on the market in another Member State the manufacturer or, where appropriate, the importer, shall provide the competent authority of that Member State with the same information, together with an indication of the recipient of the first notification;

(c) where necessary, the competent authority shall be empowered to require the manufacturer or, where appropriate, the importer, to produce the scientific work and the data establishing the product's compliance with Article 1(2) and (3) together with the information provided for in point (a) of Article 9(3). If such work is contained in a readily available publication, a mere reference to this publication shall suffice".

Article 6 of the FSMP Directive makes it clear that Member States are required to prohibit trades in product which do not comply with the Directive as from the implementation date (1^st November 2001).

(b) Guidance provided by the Defendant on FSMPs

In England the Competent Authority for the purposes of Article 5 notifications under the FSMP Directive is the Defendant which has established a notification procedure and a standard notification form (entitled "Notification of Medical Foods"). Guidance as to the process, entitled "Guidance Notes on the Notification of Marketing of Foods for Particular Nutritional Uses, Medical Foods and Infant Formula" has been produced. The Guidance Notes were first issued in 2008 and then revised in March 2013 (the 2013 Guidance Notes) and again in April 2014 (the 2014 Guidance Notes). The 2013 Guidance Notes explain that the information set out in the Notes aims to provide non-statutory guidance on the notification rules as part of the duty upon the Defendant to perform "efficient official monitoring" under the FSMP Directive. The intended audience of the Notes are "…all companies who intend to market for the first time in the UK foods for particular nutritional uses, medical foods and infant formula, and those local authorities who are responsible for enforcing the legislation in this area". The Notes explain that the implementation of the Directive for particular nutritional purposes, medical foods and infant formula is upon a devolved basis. However, the Guidance applies across the UK. It is explained that the Notes are intended to be read in conjunction with (inter alia) the FSMP Directive (cf. Section B1). Section B of the Notes concerns medical foods. It provides a summary of the FSMP Directive. The Guidance explains that any medical food intended for sale within the UK must meet the compositional and labelling requirements set out in the Directive and that medical food products intended for sale within the UK must be notified. The Notes go on to explain who the relevant authorities are who have responsibility for enforcement of the law in this area and the offences which may be committed in the event of non-compliance and the penalties therefore. It is evident from the Notes that the regime that those subject to it must comply with comprise a combination of the FSMP Directive and the domestic, implementing regulations which, in relation to England are the Medical Food (England) Regulations 2000 (SI 2000 No 845) ("the MFER"). The Notes explain, in some detail, how the notification procedure operates.

It is clear that the Defendant considers that as part of its monitoring duty it must establish whether a product is or is not an FSMP; and, that this duty is imposed upon it by the FSMP Directive and MFER. In paragraph [B10] under the heading "Will further information be required by the competent authority?" the following is stated:

"The competent authority may require the notifying company to produce the evidence to establish the product's compliance with the definitions for "medical food" (Article 1(2) of the Directive) together with information on the particular elements of the qualitative and quantitative composition. If such work is contained in a readily available publication, reference to this publication will suffice. Failure to produce such information is an offence under the Regulations".

The view of the Defendant, as articulated in the 2013 Guidance Notes, was that it was within its monitoring remit and task to "establish the product's compliance with the definitions" in the Directive.

The "monitoring" role of the Defendant, qua Competent Authority, does not extend to operating as a prior approval authority (such as, for instance, occurs within the medicines regime). The Defendant recognises that its competence falls short of enforcement or of a right to confer approval. This is made clear within the Notes which contain the following material passage at pp 16-17 (which is the same as the 2008 Guidance Notes that were in place when Souvenaid was first notified to the DoH in 2012):

"Will the competent authority check compliance of a product with the definition for a medical food or its labelling?

No. Notification of a food product under these Regulations should not be viewed in any way as competent authority 'approval'. The competent authority may request further information as to the product's compliance with the definitions and compositional elements or manufacturing process that gives the product its particular characteristics (see Section 10 of these guidance notes). However, it is the responsibility of the manufacturer/importer to ensure that a food product complies with the relevant legislation. Enforcement of food law is the responsibility of local authorities, usually through trading standards or environmental health departments. Guidance on compliance of specific products with food legislation should be sought from your local trading standards or environmental health department".

The 2013 Guidance Notes were updated in 2014. These had the effect of correcting an acknowledged error in the 2013 Guidance Notes which (at paragraph B17) purported wrongly to confer upon the Competent Authority a power to suspend or restrict trade. However, as is set out above at paragraphs [34ff], this power relates to PARNUTS, but not FSMP products. Nonetheless, the 2014 Guidance Notes (at paragraph B10) repeats the statement that the Competent Authority may require notifying companies to produce evidence to establish the product's compliance with the definitions for medical food contained within Article 1(2) FSMP Directive.

(c) The Medical Food (England) Regulations 2000 – "MFER"

The FSMP Directive was transposed into English law by the MFER. It is common ground between the parties that the implementation was, in numerous material respects, unsatisfactory. It is plain that the basic stance adopted by the draftsman was to incorporate the FSMP Directive by cross-reference and supplement that by: adding some definitions; imposing a sales restriction; identifying enforcement bodies; setting out offences and penalties; and applying selected provisions of the FSA 1990 by cross-reference. The net effect is that implementation of the FSMP Directive in England emerged through a patchwork of cross-references. The complications which this has given rise to are reflected in Issue I which I consider at Section D below.

The MFER were introduced pursuant to powers conferred upon them by various provisions of the FSA 1990. For unspecified reasons the implementation did not occur pursuant to the European Communities Act 1972, but nothing turns upon this.

Regulation 2 entitled "Interpretation" makes it plain that the MFER implement the FSMP Directive as amended. There is no definition of "food authority" even though, pursuant to Regulation 4, it is each "food authority" that has imposed upon it the duty (cf. use of the word "shall") to enforce and execute these regulations in the respective areas of each food authority. It appears to be common ground between the parties that the food authorities are those set out in the FSA 1990 but curiously Regulation 7, which applies various provisions of that Act, does not apply the provision which concerns the definition of food authority. Be that as it may, Regulation 2 specifies certain bodies that are not food authorities. Finally, in relation to definitions, "medical food" means "…food coming within the classification of dietary foods for special medical purposes for which compositional and labelling requirements are laid down in the Directive", i.e. an FSMP.

Regulation 3 entitled "Restrictions on sale" imposes two statutory prohibitions upon the sale of medical foods. "Sale", for present purpose, includes possession for sale and offer exposure or advertisement for sale (otherwise than by means of a label or wrapper) (cf. Regulation 2).

The first restriction relates to adherence to formulatory, compositional and labelling requirements. Regulation 3(1) states:

"(1) No person shall sell a medical food unless –

(a) its formulation and composition comply with Article 3 of the Directive as read with the Annex thereto and its instructions for use are such that its use in accordance with those instructions which so comply;

(b) the name under which it is sold complies with Article 4(1) of the Directive; and

(c) it is labelled in accordance with Article 4(2) to (5) of the Directive".

Pursuant to Regulation 5 any person that contravenes the prohibition contained within Regulation 3(1) is guilty of an offence and is liable on summary conviction to a fine not exceeding level 5 on the standard scale.

Although it is not relevant for the purpose of this judicial review the offence created by the MFER concerns the presentation of products that are FSMPs; it does not, at least prima facie, create an offence for selling a product as an FSMP that in fact and law is not an FSMP. Although I express no definitive view on whether this is the way to read the provision, if it is correct then the UK is seemingly in breach of its duty under Articles 2 and 6 of the FSMP Directive.

Regulation 3(2) imposes a restriction upon the sale of un-notified products and focuses upon the notification requirement contained within Article 5 of the FSMP Directive. It provides as follows:

"(2) No person who, in respect of a medical food of a particular type –

(a) is a designated notifier that is to say a manufacturer or an importer covered by Article 5 of the Directive, but

(b) has failed to comply with the requirement to notify the competent authority referred to in that Article,

shall sell a medical food of that type".

Pursuant to Regulation 5, on offences and penalties, if a person "without reasonable excuse" contravenes Regulation 3(2) then that person shall be guilty of an offence and liable to a fine of the same magnitude as for a violation of Regulation 3(1).

For the purpose of the notification duty under Regulation 3(2) the Competent Authority is, in respect of medical food manufactured in England or imported into England from the EU, the Defendant.

The instrument communicated by the Defendant to the Commission pursuant to the FSMP Directive declaring the Defendant to be the relevant "Competent Authority" represents one component of the measures adopted by the UK implementing the FSMP Directive.

It is notable that within the MFER there is no elaboration or elucidation of the role and obligation of the Competent Authority qua monitoring body for the purpose of Article 5 of the FSMP Directive. However, it is clear that it was at all times intended that the Defendant would exercise a monitoring function and the notification to the Commission of the Defendant as the "competent authority" for Article 5 purposes makes this clear. Indeed, were this not to be the case then there would be no utility or point in criminalising a failure to notify the Competent Authority pursuant to Article 5. I have already observed that the MFER incorporate by cross-reference the express provisions of the Directive (but without reciting them). The legislative technique was to, in effect, bolt on to the Directive such incremental provisions as the draftsperson considered necessary in order to give the FSMP Directive proper effect within England. This conclusion is supported by the terms of the Guidance Notes issued periodically by the Defendant which are intended to supplement the MFER and the Directive.

(d) The new regime - Regulation (EU) 609/2013: 12^th June 2013

It is relevant, finally, to record that the PARNUTS and FSMP regime is in the process of being replaced by Regulation 609/2013 which entered into force in July 2013 but which shall only be applicable from 20^th July 2016 (with certain limited exceptions which are not relevant to the present case). This new measure is designed to bring the legislation into line with more developed medical, scientific and nutritional thinking. It is evident from the recitals to the Regulation that its inception has been brought about by developments in policy relating to such matters as obesity and pesticides, and that disparities in the manner in which different Member States interpreted key definitions within the legislative regimes were also relevant. By way of example recital 9 to the Regulation states as follows:

"(9) A report from the Commission of 27 June 2008 to the European Parliament and to the Council on the implementation of that notification procedure showed that difficulties can arise from the definition of "foodstuffs for particular nutritional uses" which appeared to be open to differing interpretations by the national authorities. It therefore concluded that a revision of Directive 2009/39/EC would be required to ensure a more effective and harmonised implementation of Union legal acts".

Further, Recital 10 cites a study report of 29^th April 2009 by Agra CEAS Consulting which confirmed the findings of the Commission report referred to above. This new analysis pointed out that the broad definitions used within the Directive had enabled an increasing number of foodstuffs to be marketed and labelled as foodstuffs suitable for particular nutritional uses. It also pointed out that the same foods were being regulated in different ways in different Member States which state of affairs undermined the functioning of the internal market, and created legal uncertainty for competent authorities, food business operators including small and medium sized enterprises and consumers. It also pointed out that there were risks of marketing abuse and distortion of competition flowing from the disproportionate manner in which Regulation was imposed across the different Member States. Recital 9 ends with the following statement:

"There is therefore a need to eliminate differences in interpretation by simplifying the regulatory environment".

Article 1 of the Regulation sets out its subject matter and makes clear that it includes food for special medical purposes. The definition of such foods in Article 2(1)(g) is materially identical to that set out in the FSMP Directive. In so far as there are differences it was not suggested in the course of this litigation that they are material to the outcome of the issues before me.

Article 3 empowers the Commission by means of implementing acts, in order to ensure uniform implementation of the Regulation, to decide whether a given food falls within the scope of the Regulation. Accordingly, the Commission will, pursuant to the Regulation, acquire the power to determine upon a definitive basis (subject to appeal to the General Court) whether a particular food constitutes an FSMP. The Commission will perform this task with the assistance of scientific opinions from the European Food Safety Authority in accordance with the procedures laid down in Articles 22 and 23 of Regulation (EC) 178/2002.

The reason that this is potentially relevant to the issues arising before me is that it is, in my view, relatively clear that there is a high prospect of the substantive question whether Souvenaid amounts to an FSMP being remitted to the Commission for ultimate determination in due course. Whether this arises by virtue of a reference from the Competent Authorities in the United Kingdom or from an authority in another Member State may remain a moot point.

C. Relevant facts

I turn now to the relevant facts.

(i) Souvenaid

Souvenaid is an especially formulated 125ml drink. It has been designed over the course of 15 years of research and development, to provide nutritional benefit for the dietary management of those with the early stages of AD. It is a 1kcal/ml, vanilla or strawberry flavoured, milk-based drink containing Omega 3 fatty acids, Uridine, Choline and a range of vitamins and minerals. It is formulated to address the apparent special nutrient requirements for those diagnosed with early AD. The recommended daily intake equates to a single 125ml bottle per day. Souvenaid is the product of combined research into the effects of nutrition upon AD between the Claimant and the Massachusetts Institute of Technology ("MIT"), that dates back to 2005. It also includes the benefit of funding from the Government of the Netherlands and from the European Union. Research into the product has included three clinical trials involving in excess of 1,000 patients with AD.

Souvenaid is designed for a single purpose, namely the dietary management of patients with early AD. It is the Claimant's intention that it is only to be used under medical supervision and is marketed to healthcare practitioners. This necessarily limits its uses and, as such, it is not marketed in the UK through general retail or "over the counter" channels. Instead, it is available under the control only of a healthcare professional such as through prescription or "HCP recommendation". Though the Secretary of State has pointed out that Nutricia sells Souvenaid from its website.

(ii) The notification of Souvenaid to the Defendant

On 30^th May 2012 the Claimant notified the Defendant qua Competent Authority of Souvenaid's status as an FSMP. The notified documents were accompanied by explanatory material detailing why it was that certain vitamins and nutrients contained within Souvenaid exceeded the maximum levels prescribed by the FSMP Directive. It was explained that the rationale was that increased levels were necessary to address the specific nutritional needs of those with early AD. However, they were still below the upper safety and tolerance limits provided by the EU.

(iii)The Defendant's concerns as to whether Souvenaid was an FSMP

The Defendant indicated to the Claimant, at that time, that both it and the ACBS had concerns that the Claimant had not provided sufficient evidence to demonstrate the nutritional needs of the intended group for this product. There was therefore a question mark as to whether the product could be considered as an FSMP.

On 14^th September 2012 the Claimant company submitted additional information to the Defendant in support of Souvenaid's status as an FSMP. In a letter from the Defendant of 15^th October 2012 the Defendant stated:

"The notification procedure is not an authorisation of the product and does not indicate approval by the Department of Health regarding foods presented as medical foods. As mentioned in our previous response we still have reservations regarding the presentation of Souvenaid as a medical food".

The Defendant also indicated at that time that, were the Claimant to make an application, the ACBS would be prepared to consider and assess whether Souvenaid complied with the definition of an FSMP for drug reimbursement purposes. There followed various exchanges between the ACBS and the Defendant. It appears from the documents before the Court that the ACBS was of the view that it wished to receive an independent expert opinion upon the matter before it reached a final conclusion.

(iv) The Advisory Committee on Borderline Substances ("ACBS")

In its evidence the Claimant has explained that its essential objective is to have Souvenaid listed in the "Drug Tariff", i.e. for it to be approved by the Defendant for reimbursement at public expense when prescribed by an NHS practitioner. I turn now to explain how the ACBS operates in the context of the Drug Tariff. I base this information in large measure upon information provided to me by the Defendant and which is reflected in Government publications and in statutory material.

The ACBS's role, in practice, as regards pricing is explained in the "Information Notes on the pricing of ACBS products". These explain that "When considering an application for inclusion in Part XV of the Drug Tariff (DT), the ACBS takes account of the clinical need for a product, its efficacy and the total price to the NHS. This document addresses the issue of total price to the NHS". The Information Notes also say that the ACBS "may conclude that a product is not suitable for 'ACBS status' in light of the total cost of the product to the NHS and the applicant will be so advised" (page [1]). For formulations similar to existing products, the ACBS "will recommend that the benchmark cost to the NHS for that category should be applied as a maximum in order to achieve 'ACBS status'"; and, "where a company wishes to increase their NHS list price and retain 'ACBS status', price increases will be benchmarked against a standard inflation comparator – the current Retail Price Index (excluding mortgages)" (page [2]).

The ACBS is responsible for advising on the prescribing of foodstuffs and toiletries; one of its two distinct functions is to advise GPs when they can prescribe non-medicinal products such as foods which are specially formulated for use by people with medical conditions. ACBS advice takes the form of its 'recommended list' which is published as Part XV of the Drug Tariff.

The statutory basis for the Drug Tariff is Regulation 89(1) of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (SI 2013/349):

"(1) The Drug Tariff referred to in section 127(4) of the 2006 Act (arrangements for additional pharmaceutical services) is the aggregate of—

(a) the determinations of remuneration made by the Secretary of State, acting as a determining authority, under section 164 of the 2006 Act (remuneration for persons providing pharmaceutical services), but not of the remuneration of dispensing doctors;

(b) the determinations of remuneration made by the NHSCB, acting as a determining authority, pursuant to regulation 91(1); and

(c) any other instruments that the Secretary of State is required by virtue of these Regulations or the 2006 Act to publish, or does publish, together with those determinations,

in the publication known as the Drug Tariff, which the Secretary of State shall publish in such format as the Secretary of State thinks fit."

The Drug Tariff accordingly incorporates the determinations of remuneration made by the Defendant, as a determining authority under section 164 of the 2006 Act. Section 164(1) provides that:

"The remuneration to be paid to persons who provide pharmaceutical services under this Part must be determined by determining authorities".

Section 164(3) provides that "determining authorities" for this purpose are (a) the Secretary of State and (b) "so far as authorised by him to exercise the functions of determining authorities, the [National Health Service Commissioning] Board or other person appointed by him in an instrument." The Secretary of State is the determining authority in relation to Part XV of the Drug Tariff.

The Drug Tariff is issued by the Defendant pursuant to Regulation 89(3) of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013. The Tariff is the aggregate of the determinations of remuneration made by the Defendant as a determining authority pursuant to section 164 of the National Health Service Act 2006. Dr Roger Phillips, the Chief Commercial Officer for the Global Medical Division of Danone Trading BV (of which the Claimant forms a part), has explained in a witness statement before the Court, as follows:

"The consequence of appearing on the recommended list is that a product is "approved" for reimbursement – i.e. payment to the dispensing pharmacists – by the NHS, which is a level of endorsement from the DoH of any prescription issued".

Dr Netherwood (on behalf of the Defendant) explains that the opening paragraph of Part XV of the Drug Tariff indicates that "prescriptions issued in accordance with the Committee's advice and endorsed "ACBS" will not normally be investigated". The Defendant has further explained that the ACBS's recommendations in respect of borderline substances are neither a necessary pre-condition for their being dispensed as part of NHS pharmaceutical services, nor are they a bar to prescriptions of listed substances being investigated on grounds of suitability.

The Claimant seeks to have Souvenaid listed in Part XV of the Drug Tariff as a FSMP, for the dietary management of early Alzheimer's disease.

The ACBS has no separate legal existence from the Defendant, nor any statutory role. It is an extra-statutory committee set up by the Defendant to provide advice on borderline substances. It is a multi-disciplinary committee comprising a range of specialist professionals and clinicians which review a product's nutritional composition and evidence for efficacy, safety, tolerance, acceptability and compliance for use of a product in clinical practice. It also takes into account health economics and the value of the product to the NHS.

(v) The discussions at the EU level

In September 2013 the Defendant engaged in discussions with the European Commission and with other Member State representatives at an expert working group. Dr Trudy Netherwood, the Food Partnerships Manager in the Obesity and Food Policy Team of the Health and Wellbeing Division at the Department for Health, has explained in evidence before the Court on behalf of the Defendant as follows:

"The [Defendant] also consulted the European Commission and other Member States regarding the interpretation of the definition of a FSMP with regard to early Alzheimer's Disease, at an expert working group on 13 September 2013. Member States generally supported and did not object to the UK's interpretation. Nutricia had indicated that they considered that the product was lawfully marketed in a number of Member States and that we should consider accepting the product under mutual recognition. The Commission clarified that mutual recognition does not apply in this area. Some Member States were not aware of any assessment being carried out on the product and some were in the process of considering an assessment".

(vi) The First Decision: 23^rd September 2013

On 23^rd September 2013 the Defendant communicated a decision ("the First Decision") to the Defendant to the effect that the Defendant had concluded that Souvenaid did not fall within the definition of an FSMP and it requested that Souvenaid no longer be marketed as an FSMP in the United Kingdom. The relevant parts of the decision letter stated as follows:

"The Department's view is that the product Souvenaid does not comply with the definition of Foods for Special Medical Purposes (FSMP)…

…the Department does not consider that there is a nutritional requirement for Alzheimer's patients that cannot be met by consumption of normal foods, which can include food supplements and fortified foods. The Department therefore considers that Souvenaid is not a FSMP".

The Defendant has made clear that this was not an enforcement decision and did not nor could bind any prosecutorial body.

A pre-action letter was sent by the Claimant to the Defendant on 30^th October 2013 challenging this conclusion. On 12^th November 2013 the Defendant replied indicating that it agreed to undertake a review of its decision upon the status of Souvenaid.

In a letter dated 9^th December 2013 the Defendant wrote to the Claimant seeking to clarify the legal effect of its decision. The contents of this letter are useful in explaining the Defendant's own understanding of the status of any decision that it was entitled to take pursuant to its monitoring obligations under the FSMP Directive. The letter stated as follows:

"The Department's position is that its decision of 23^rd September 2013 remains its view of the status of Souvenaid for the time being. However, its view would not be binding upon the criminal courts, and given that the Department has agreed to review its decision, the Department's position is that its subsisting decision would inevitably not now be given the same weight in criminal proceedings that it would have been given in the absence of the pending review. Matters have clearly moved on, even though the subsisting decision has not been quashed.

However, the Department is not the relevant enforcement authority – enforcement would be a matter for local authorities – and neither can it confer any immunity from prosecution in the event that Souvenaid remains on the market as a FSMP and a local authority chooses to take enforcement action against it. The Department's view of the balance of convenience is that the product should not be presented or promoted as a FSMP pending the outcome of the review, but it acknowledges that it cannot insist on this.

We trust this clarifies the position and we also confirm that the application by your client to the Advisory Committee on Borderline Substances will be considered following the outcome of the Department's review of the product as to whether the product complies with the compositional and labelling requirements as set out in the Directive".

Proceedings were nonetheless issued by the Claimant on 20^th December 2013; though these proceedings were then stayed pending the review. The Defendant sought opinions from nutrition experts within Public Health England ("PHE") which provides nutritional advice for the population including sub-groups thereof that have specific requirements according to lifestyle or medical conditions. The PHE nutritionists were asked to consider the nutritional needs of people with early AD. The Defendant considered that this body had the appropriate qualifications and experience to perform the task. Dr Netherwood, in her witness statement, has explained the process that ensued in the following terms:

"24. The DH legal team organised two meetings with Nutricia as part of the review process, one with me and the legal teams to discuss the terms of the review, and one with me, legal teams and the PHE nutritionists to discuss the product and scientific evidence. I explained that the initial meeting for a product to fall within the definition of a FSMP, it must be something that the particular patient group specifically needs because of the medical condition, and it must be the case that the nutrients could not be obtained from other foodstuffs. I mentioned the disease Phenylketonuria (PKU) which I describe as a "classic example" of disease where such patients require a nutritionally incomplete FSMP with a nutrient adapted formulation for a specific disease (Article 1.3(c)). Proteins are made of different types of amino acids. People with PKU are unable to process the amino acid phenylalanine. They cannot therefore eat a normal diet. They have to eat a low protein diet and also consume a FSMP containing the amino acids that their body is able to digest, without phenylalanine. Eating a regular diet would lead to problems, including brain damage, and if they ate a diet which excluded proteins without consuming a FSMP, this would also have severe consequences, particularly for children, and may even lead to death.

25. Once a person is diagnosed with PKU by a physician, they will be prescribed an appropriate FSMP(s). All patients with PKU require FSMPs. It is not something that a doctor might simply think that a particular patient with PKU might obtain some benefit from. There needs to be a recognised component of the disease such that a specific nutritional requirement can only be corrected by the FSMP. A clinician may recognise a benefit in the product for their patients, but this does not mean that the product falls in the definition of a FSMP".

(vii) The EU Standing Committee meeting: 10^th February 2014

It is apparent that at about this time the Defendant was articulating its (sceptical) position to other Member States within the EU. It did so both at a meeting on 10^th February 2014 and in bilateral communications with other Member States. The UK Permanent Representative to the EU thus explained to the representative of a third Member State that the position of the UK at the meeting on 10^th February 2014 was in the following terms:

"Souvenaid is being marketed as a Food for Special Medical Purposes with the claim "for the dietary management of early Alzheimer's Disease". Nutrition advice from Public Health England (PHE) for people with Alzheimer's Disease is to eat a healthy balanced diet. Overall, in conclusion, the evidence to suggest that patients with Alzheimer's Disease require additional nutrients to the rest of the population to improve symptoms or slow progression of the disease is currently inconclusive. The UK's view was that the product Souvenaid does not comply with the definition of Foods for Special Medical Purposes (FSMP) as there is not a recognised dietary need for alternative nutrient sources for the patient group; all the nutrients may be obtained from a healthy balanced diet. However this is being reviewed, therefore we are seeking views from the Commission and Member States".

A Summary Report of the Standing Committee on the Food Chain and Animal Health of the meeting of 10^th February 2014 records the general position adopted by the delegates generally in relation to Souvenaid. The Summary Report also highlights a growing concern articulated by the Commission that products which were properly food supplements were being marketed as FSMP. The Commission emphasised to the delegates of the Member States the need for a proper evaluation of the requirements of Article 1(2)(b) of the FSMP Directive:

"A.04 Request from the United Kingdom for a discussion on Article 1.2(b) of Commission Directive 1999/21/EC on dietary foods for special medical purposes

On the request of the UK the Committee discussed whether a product containing a combination of nutrients such as vitamins, minerals and omega-3 fatty acids and marketed "For the dietary management of early Alzheimer's disease" would fall within the scope of the definition of Food for Special Medical Purposes (FSMP), according to Article 1(2)(b) of Commission Directive 1999/21/EC on dietary foods for special medical purposes.

The UK delegation explained that their authorities are currently in talks with an operator who manufactures a product with this composition. After having informed the operator of their initial doubts that the product would comply with the definition of FSMP, the UK authorities were asked by the operator to reconsider their decision since the product is also marketed as an FSMP in other Member States. The UK delegation therefore asked for the views of other Member States and in particular whether the principle of mutual recognition applies in this situation.

Discussions within the Committee confirmed that the product is on the market of different Member States as an FSMP. Of the delegations that intervened, one explained that the product was accepted because of the principle of mutual recognition. Another one explained that the product was accepted following an assessment of the data submitted by the operator. The operator was however asked to market the product "for the dietary management of cognitive loss among the elderly population" rather than "for the dietary management of early Alzheimer's disease". Another delegation explained that the matter is currently being assessed by their national scientific authority in order to understand whether early Alzheimer's disease patients have special dietary needs.

Several delegations intervened in support of the position of the UK authorities that the product would not comply with the definition of FSMP and a request was made that the broader issue of classification of products as FSMPs is tackled by the Commission in a guidance document.

The Commission noted that increasing numbers of products appear to be notified as FSMPs in Member States. This may be due to the implementation of the Regulation on nutrition and health claims and to the forthcoming abolition of the concept of dietetic foods. In that context, the marketing of a product as an FSMP, instead of as a food bearing a claim, could enable it to be placed on the market with a statement that refers to the dietary management of a disease, disorder or medical condition, following only notification of the product to the competent authorities, rather than following the procedure for authorisation of a health claim. While the final decision on the classification of products lies with the national competent authorities, discussions in the Committee can provide guidance on the matter. Further it was recalled that as of 20 July 2016, the Commission will also have the right, pursuant to Article 3 of Regulation (EU) No 609/2013 on food for specific groups, to adopt implementing measures to decide whether a given food falls within the scope of the Regulation and, for example, whether a given food would be a FSMP. The Commission also took note of the request of the delegations to provide advice to national authorities in the context of a guidance document.

The Commission clarified that the principle of mutual recognition does not apply in areas where the legislation is harmonised and is therefore not relevant in an area where Directive 1999/21/EC provides harmonised rules, including a definition, that are applicable to FSMPs throughout the EU. The matter brought forward by the UK delegation is related to the application of the legislation by the national competent authorities, who have the right and obligation to ensure that products on their market comply with the relevant EU legislation. Decisions of national authorities can be challenged in courts, and the ultimate responsibility for the interpretation of EU law lies with the Court of Justice of the EU.

The Commission recalled the definition of FSMPs given in Article 1(2)(b) of Directive 1999/21/EC and drew the attention of Member States on the consequences that a broad interpretation of this definition could entail. In this context, it called on Member States to take into account all the elements of the definition, including the one whereby FSMPs are intended for "(…) medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet (…)". The Commission underlined that food supplements are regulated as foods and modification of the normal diet can include use of food supplements. It suggested that Member States pay particular attention to whether products notified as FSMPs would not in fact be food supplements".

It is accordingly evident that even very recently there exists a divergence of views as to the scope and effect of the Directive, including as to whether there is a principle of applicable mutual recognition. There is also a variety of different outcomes being reached by Competent Authorities in differing Member States.

The Claimant is generally very critical of the way in which thinking has evolved within the EU and complains that the Defendant derives reliance from the fact that the Commission appears to support the position adopted by the Defendant and that the Commission has suddenly sought to "…press amongst Member States a more (and overly) rigourous approach towards FSMPs [which] appears to have strongly influenced the approach of the [Defendant] towards their review of Souvenaid".

(viii) The instruction of Dr Dangour

On 29^th April 2014 the Claimant submitted another dossier of studies and research papers in order to prompt reconsideration of what, to the Claimant, appeared to be an increasingly fixed position on the part of the Defendant. On 18^th June 2014 the Defendant announced its decision to instruct an independent expert, Dr Alan Dangour, in order to advise upon the status of Souvenaid in the light of the new evidence tendered. Dr Dangour has experience of research of the effects of nutritional supplementation on health and function in later life including a previously published paper on nutrition and Alzheimer's Disease.

PHE subsequently produced a report which reviewed the evidence supplied by Nutricia and which includes an assessment of the conclusions of Dr Dangour.

On 18^th July 2014 the Defendant disclosed to the Claimant the reports received from Dr Dangour and PHE. The instructions to both were to consider:

"• whether patients with early Alzheimer's D have a specific essential nutritional need; and

• if they do can these requirements be met by normal diet or modification of the diet (which may include food supplements and fortified foods)".

(ix) The Final Decision: 8^th August 2014

On 8^th August 2014 the Defendant sent to the Claimant a letter expressing the view that Souvenaid was not an FSMP ("the Final Decision"). In this the Defendant explained that the Department had held discussions with the Commission and Member States including during the Standing Committee on 10^th February 2014. The essential or core reasoning behind the decision reflects "the intake point" and "the modification point" and was in the following terms:

"The first part of the definition of a FSMP indicates that a product should be intended for feeding patients with specific nutrient requirement as a consequence of a limited, impaired or disturbed capacity to take, digest, absorb metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites or with other medically-determined nutrient requirements

The Department of Health has carefully considered all the evidence submitted by Nutricia Limited and has concluded that the evidence does not demonstrate that people with early Alzheimer's Disease have special nutritional requirements. This results in the Department maintaining the view that the product Souvenaid does not fall within the definition of an FSMP and the Directive 1999/21/EC and should not therefore be presented as a Food for Special Medical Purposes with the indication "for the dietary management of early Alzheimer's Disease".

The Department of Health has further concluded that, even if people with early Alzheimer's Disease were to have a special nutritional requirement as maintained by Nutricia, this could be met by modification of the normal diet, by other foods or particular nutritional uses, or by a combination of the two".

Dr Netherwood has explained in her witness statement evidence before the Court that the Defendant advised the Claimant that Souvenaid may be marketed alternatively as a food supplement or fortified food and that healthcare professionals could continue to recommend the product and that it could still be recommended for the Drug Tariff depending upon the ultimate decision of the ACBS, which was still in abeyance. The Defendant has also informed the Claimant that there are a number of currently approved health claims which may be applied to the product to enable it to be marketed to a wider audience. Further, an application could be made for an EU authorised disease risk reduction claim. Dr Netherwood states that it is apparent from the Claimant's US website that in the USA the Claimant is seeking to market Souvenaid to "help support memory in aging adults", rather than as a medical food for patients with early AD.

D. Issue I: Did the Department of Health have the power to take the Final Decision?

(i) The Issue

I turn now to the specific issues arising. The Claimant contends first that there was no legal basis for the Defendant to adopt any decision to review Souvenaid for compliance with the definition of an FSMP. Further, the Claimant construes the Final Decision as one in which the Defendant is seeking in substance and effect to restrict the Claimant's ability to market Souvenaid in England as an FSMP.

In the course of the oral hearing Mr de la Mare QC for the Claimant sensibly accepted a number of propositions which had the effect of narrowing down somewhat the dispute between the parties. In particular he accepted that, in principle, the FSMP Directive conferred upon Member States a power to decide the question of the proper classification of a food product as an FSMP or, indeed, any other of the potentially alternative relevant classifications. However, he submitted that the MFER did not properly, or at all, implement that power into English law and, accordingly, there was no power for the Defendant to adopt the Final Decision. Mr de la Mare QC also accepted that it would in principle be open to the Defendant to amend the MFER in order to insert that power; but he submitted that until that happened there was no legal basis upon which the decision could be taken.

It was also accepted that it was within the powers of the Defendant to form a "view" on whether a product, such as Souvenaid, constituted an FSMP in law for purposes unrelated to the FSMP Directive, for example for the purposes of the Drug Tariff. However, he submitted that it was plain on the face of the Final Decision that it was directed at the restriction on sales provisions of the FSMP Directive (i.e. Article 6) and the equivalent provisions within the MFER and not with any collateral issue such as reimbursement or the Drug Tariff.

Issue I thus exists within a relatively narrow compass.

(ii) Analysis of Final Decision

For reasons explained below it is important to be clear as to effect of the Final Decision. There are a number of points to be made about it.

First, the decision is addressed to the Claimant and concerns the scope and effect of the FSMP Directive. It is plain from the Final Decision read as a whole that it is squarely directed at the sales restrictions contained within Article 6 of the FSMP Directive which provision is implemented by Regulation 5 of the MFER. Further support for this conclusion is found in the heading to the Final Decision which makes clear that it communicates the result of the Defendant's review of whether Souvenaid complied with the definition of an FSMP under the FSMP Directive. I draw from this the conclusion that the subject matter of the Final Decision is one falling within the confines of the FSMP Directive. It cannot be justified upon the basis that it is directed towards some collateral legitimate purpose (such as the Drug Tariff), albeit that in practice it might well serve such a purpose.

Secondly, the Final Decision purports merely to express the "view" that Souvenaid does not constitute an FSMP. This "view" is based upon the Defendant's conclusion that the evidence "…does not demonstrate that people with early Alzheimer's Disease have special nutritional requirements". The use of the phrase "view" was seemingly deliberate and designed, carefully, to reflect the role which the Defendant considered it was entitled and required to perform in "monitoring". It reflects the explanation given in the letter of 9^th September 2013 (set out at paragraph [91] above). Mr Henshaw QC explained that the Defendant unreservedly accepted that the FSMP regime, unlike for instance that in relation to medicines, did not involve a prior approval process and that, accordingly, the Defendant had no jurisdiction to decide, definitively, whether a product could be marketed or not. It was in this context that the expression of a "view" was appropriate, as opposed to the more prescriptive or mandatory language that would be expected to be found in a decision under a prior-authorisation regime.

Thirdly, the substance of the "view" was that Souvenaid "…should not therefore be presented as a Food for Special Medical Purposes with the indication "for the dietary management of early Alzheimer's Disease"". The Final Decision is not expressed in prohibitive terms; it does not, for example, indicate that the Claimant is not authorised to place the product on the market, or that the Claimant must cease and desist from marketing or that the Defendant intended to commence enforcement or other regulatory proceedings. In context it is merely an expression of opinion as to the consequences of its conclusion that Souvenaid did not amount to an FSMP.

The Final Decision is thus a limited creature and has a limited effect. The Defendant acknowledges that it is not the enforcement agency under the MFER and that its "view" could be no more than a matter which a prosecutorial authority could take cognisance of. The Defendant does not even go so far as to submit that in law in the course of a prosecution its view would necessarily even be admissible in evidence before a jury. As such the Final Decision does not directly impact upon the legal rights and obligations of Nutricia. Although it was addressed to Nutricia its true effect is limited. It was not even addressed to relevant prosecutorial authorities where, arguably, it exerts its most potent effect, or to the members of the ACBS to facilitate their advisory function vis-à-vis the Defendant. Pulling the threads together it would not be right to describe the Final Decision as a purely internal matter since it was addressed to Nutricia; but its effect is limited and has its greatest effect internally in that (i) it might be a matter a prosecutor takes into account when deciding whether to bring enforcement proceedings; and (ii) it is a matter the ACBS may take into consideration in developing and formulating the advice it then gives to the Defendant.

The question now arises as to whether this decision is of a type which it is within the powers of the Defendant to adopt.

(iii) Conclusions

(a) The Final Decision was intra vires

In my judgment in principle a decision on issues of classification is one which lies within the powers of the Defendant to adopt and the Final Decision was not therefore ultra vires. This conclusion is, of course, without prejudice to the challenge to the substance and merits of that specific decision. At this stage I am considering only the power of the Defendant to adopt a decision of this type.

Notwithstanding that the MFER is in some respects an unsatisfactory instrument through which to implement the FSMP Directive, the question for this Court is how to make sense of a system that has been in force for some years and has not thrown up (at least until now) insoluble problems of workability. There are a number of reasons why I conclude that the Defendant acted intra vires in adopting the Final Decision.

(b) The Marleasing approach to interpretation

The starting point is to identify the test to be applied to the interpretation of the MFER. The present case involves the construction of domestic law which covers a field of operation specified in an EU directive. The basic principles which govern interpretation in such cases were laid down in the seminal judgment of the Court of Justice in Case 106/89 Marleasing SA v La Commercial Internacional de Alimentacion SA [1990] ECR I-4135 ("Marleasing")

That judgment set out three main principles which govern the process of interpretation. The first is that there is a general duty imposed by EU law upon Member States (including national courts) to comply with the terms of a directive. The second is that so far as possible implementing measures must be interpreted purposively in order to achieve the result set out in the directive. The third is that this principle of interpretation applies also to national measures which fall within the field or scope of the directive but which have not been specifically identified as implementing measures; this is because the duty to ensure consistency with the directive applies to "national law" not simply those parts of national law that have, in effect, been ear-marked as the particular transpositional measures.

In Marleasing the Court stated (cf. paragraph [8]) that the Member State's obligation arising from a directive to achieve the result envisaged by the directive and their duty under Article 5 of the Treaty to take all appropriate measures, whether general or particular, to ensure the fulfilment of that obligation was binding upon all of the authorities of Member States including, for matters within their jurisdiction, the Courts: citing Case 14/83 Von Colson & Kamann v Land Nordrhein-Westfanen [1984] ECR 1891 paragraph 26. The Court continued to state as follows:

"8…It follows that, in applying national law, whether the provisions in question were adopted before or after the Directive, the national court called upon to interpret it is required to do so, as far as possible, in the light of the wording and the purpose of the Directive in order to achieve the result pursued by the latter and thereby comply with the third paragraph of Article 189 of the Treaty".

On the facts of the case of Marleasing the application of the above principles of interpretation meant that national courts were precluded from arriving at a result, otherwise directed by ordinary principles of domestic law interpretation, which was inconsistent with the result required by the directive. In that case the directive in question (which related to safeguards for shareholders and others in companies) sought to limit the circumstances in which nullity could arise and the retroactive effect of a declaration of nullity in order to ensure "…certainty in the law as regards relations between the company and third parties, and also between members". This object was evident from the recitals to the directive, but was not expressly articulated in the substantive provisions of the directive. Nonetheless the Court stated:

"It follows, therefore, that each ground of nullity provided for in…the Directive must be interpreted strictly. In those circumstances the words "objects of the company" must be understood as referring to the objects of the company as described in the instruments of incorporation or the articles of association".

The Court also addressed the issue of which national laws were subject to this approach to interpretation. The narrow alternative (rejected by the Court) was that it was only those measures which were specifically introduced by the Member State as implementing measures which had to be so construed. The Court made clear that it was all national law(s) which fell within the scope ratione materiae of the EU measure. The Court accepted this by making clear that the principle of purposive interpretation to achieve the posited result applied to national law irrespective of whether it pre or post dated the directive in issue (see the quotation at paragraph [116] above). Equally, and consistently, Advocate General Van Gerven in his opinion explained that a directive takes precedence over "all provisions of national law" and this extends to all that is within the "…branch of the law covered by the directive and [which was] not enacted for its implementation". The Advocate General also pointed out that the Court had already stated that even in relation to non-binding recommendations national courts were required to take into consideration the contents of the recommendation even where the national law was not adopted to give effect to the recommendation: See (ibid) page I-4147 paragraph [9] citing Case C-322/88 Grimaldi v Fonds des Maladies Professionales [1989] ECR 4407.

These principles of interpretation were also articulated by the Court in its formal answer to the referring Court which was that a national court hearing a case falling within the scope of the Directive was "…required to interpret its national law in the light of the wording and the purpose of that Directive in order to preclude a declaration of nullity over public limited company on a ground other than that listed in Article 11 of the Directive".

(c) The limits of the Marleasing approach

The interdict to Member States, and their courts, to achieve the result set out in the directive is thus a strong one. However, whilst being a forceful instruction, it is nonetheless not absolute. In paragraph [8] of the judgment, recited above at paragraph [116], are to be found the words "as far as possible". The principle of purposive instruction is not, therefore, a rule which requires national courts to do permanent and irrevocable damage to the language of domestic implementing legislation, or other legislation existing within the field and scope of the directive, in order to achieve the object of the Directive. So for instance it is not possible to construe a national measure to mean "black" (the requirement in the Directive) when it explicitly states that it means "blue". Equally, a supervening directive cannot create a criminal sanction or civil nullity in national law when there is no corresponding sanction or consequence implemented into national law: See Marleasing per Advocate General Van Gerven (ibid) at page I-4147 paragraph [8], because this would offend against the principles of legal certainty and non-retroactivity.

(d) The mechanics of implementation: the choice of "form and method"

Member States have discretion over the choice of "form and method" of implementing measure. The Court has emphasised that whilst the choice of "form and method" of implementation is a matter for the discretion of the Member State, this is not an unfettered discretion. Case law has expanded upon the manner in which the process of transposition should occur. In a series of cases the Court has sought to delineate when a Member State must transpose using specific measures of implementation and when it is not essential. The key determinants of this issue are whether the directive imposes rights and/or obligations upon private parties. Where this is so then the Court expects to see clear measures of domestic implementation which meet the requirement of legal certainty and transparency. Where, however, the directive is addressing a matter which is essentially internal to the administration of the Member State then there is a far broader discretion as to choice of form and method and specific legislative measures are not always required.

In Case C-233/00 Commission v France [2003] ECR I-6625 the Court held:

"76. While it is therefore essential that the legal situation resulting from national implementing measures is sufficiently precise and clear to enable the individuals concerned to know the extent of their rights and obligations, it is none the less the case that, according to the very words of the third paragraph of Article 189 of the Treaty, Member States may choose the form and methods for implementing directives which best ensure the result to be achieved by the directives, and that provision shows that the transposition of a directive into national law does not necessarily require legislative action in each Member State. The Court has thus repeatedly held that it is not always necessary formally to enact the requirements of a directive in a specific express legal provision, since the general legal context may be sufficient for implementation of a directive, depending on its content. In particular, the existence of general principles of constitutional or administrative law may render superfluous transposition by specific legislative or regulatory measures provided, however, that those principles actually ensure the full application of the directive by the national authorities and that, where the relevant provision of the directive seeks to create rights for individuals, the legal situation arising from those principles is sufficiently precise and clear and that the persons concerned are put in a position to know the full extent of their rights and, where appropriate, to be able to rely on them before the national courts (see, inter alia, Case 29/84 Commission v Germany [1985] ECR 1661, paragraphs 22 and 23, and Case C-217/97 Commission v Germany, cited above, paragraphs 31 and 32).

77. Consequently, it is important in each individual case to determine the nature of the provision, laid down in a directive, to which the action for infringement relates, in order to gauge the extent of the obligation to transpose imposed on the Member States".

To the same effect are: Case C-296/01 Commission v France at paragraph [55]; and, more recently Case C-29/14 Commission v Poland at paragraph [38].

Administrative practices may sometimes be sufficient. In Case C-177/03 Commission v France (radiological emergency) [2004] ECR I-11671 a directive required information to be provided to the population likely to be affected in the event of a radiological emergency. Article 8 of the directive required such information to include details of the authorities responsible for implementing health measures. The Court held that this requirement did not require specific implementing measures in national law. It sufficed that details of the responsible authorities were given through the media in practice:

"56. The Commission points out that, according to Article 8 of the Directive, the information referred to in Articles 5, 6 and 7 is also to 'mention the authorities responsible for implementing the measures referred to in those articles'. The practice of the French authorities, whereby details of the responsible authorities are given through the media used for informing the general public, cannot in that respect be regarded as sufficient to ensure the correct and complete implementation of Article 8 of the Directive. It does not meet the requirements of legal certainty.

57. It must be borne in mind that, according to the very terms of the third paragraph of Article 161 EA, the Member States are entitled to choose the form and methods for implementing directives which best ensure the result to be achieved by the directives. It is clear from that provision that the transposition of a directive into national law does not necessarily require legislative action in each Member State. Thus, the Court has repeatedly held that it is not always necessary formally to enact the requirements of a directive in a specific express legal provision (see, to that effect, Case C-233/00 Commission v France [2003] ECR I-6625, paragraph 76, and Case C-296/01 Commission v France [2003] ECR I-0000, paragraph 55).

58. It is in the light of that case law that the Commission's sixth complaint must be considered.

59. In this case, the Commission has not in any way demonstrated that compliance with the obligation laid down in Article 8 of the Directive requires specific implementing measures to be incorporated into national law.

60. Moreover, the Commission acknowledges the existence of a practice on the part of the French authorities, whereby details of the responsible authorities are given through the media used for informing the general public, but has not shown how that practice is contrary to the obligation laid down in Article 8 of the Directive.

61. Accordingly, the sixth complaint must be rejected as unfounded."

With regard more particularly to the question of monitoring, if a directive imposes an explicit obligation on Member States to "establish" a monitoring system then, of course, the broad discretion to rely on administrative practice which might otherwise exist is taken away; the Member state must follow the instruction to "establish" the system in national law. In Case C-6/04 Commission v UK the Court was concerned with Article 12(4) of the Habitats Directive (92/43/EEC) which expressly required that: "Member States shall establish a system to monitor the incidental capture and killing of the animal species listed in Annex IV(a). In the light of the information gathered, Member States shall take further research or conservation measures as required to ensure that incidental capture and killing does not have a significant negative impact on the species concerned. The Court held that in these circumstances precise measures of implementation were required and rejected the submission of the United Kingdom that it sufficed to confer specific powers on nature conservation bodies and to impose on them a general duty to exercise their functions so as to secure compliance with the requirements (cf. paragraph [23]). This was because: (a) management of the common heritage was specifically entrusted to the Member States in their respective territories which made faithful transposition particularly important (paragraph [25]); (b) the directive laid down "complex and technical rules in the field of environmental law" and expressly imposed "fundamental surveillance and monitoring obligations" (paragraph [26]); and (c), the UK legislation "[did] not establish a precise legal framework in the area concerned, such as to ensure the full and complete application of the directive and allow harmonised and effective implementation of the rules which it lays down" (paragraph [27]).

(e) The application of the Marleasing principle to the MFER

The issue, therefore, for me in the present case is to see whether the MFER in accordance with these principles can be construed purposively, in order to achieve the object of permitting the Defendant to perform its duty under the FSMP Directive to monitor compliance with the FSMP regime and take classificational decisions.

In my judgment this is possible.

First, the starting point is to recognise that the subject matter of the dispute is the power to adopt a monitoring decision on classification which has the limited, and in large measure internal, effects set out above at paragraphs [106ff]. The Final Decision does not confer or impose rights or obligations upon Nutricia. This is not, in my view, a case where detailed express domestic law provisions are required to ensure legal certainty or transparency.

Secondly, the structure of the MFER is based upon an assumption that it supplements the FSMP Directive. It is for this reason that it incorporates by reference the substantive provisions of the FSMP Directive. Thus, the formulation and compositional requirements in Article 3 of the FSMP Directive are incorporated by reference into Regulation 3(1)(a) of the MFER. The naming and labelling requirements under Article 4 are incorporated into Regulation 3(1)(b). The "requirement to notify" the Secretary of State for the purpose of monitoring under Article 5 of the FSMP Directive is incorporated by reference into Regulation 3(2) and (3) and Regulation 5. The substantive provisions of the FSMP Directive are thus expressly incorporated by reference into the MFER and, indeed, the MFER would simply not work without wholesale incorporation of the substance of the FSMP Directive. The drafting assumption is that the FSMP Directive and MFER work together as a composite whole. I should add that it has not been submitted that it is impermissible for a domestic measure to incorporate an EU directive by cross-reference, particularly in relation to matters which do not address private and personal rights and obligations. This process of incorporation by cross-reference is no more offensive than the cross referencing found elsewhere in the MFER to the provisions of the FSA 1990 which are said also to apply. In the UK this is a perfectly normal drafting technique. Ease of access is a relevant factor. In a real and practical sense however nowadays it takes no longer to locate and bring up the underlying directive than it does the MFER: both are available more or less instantaneously on the internet. Long gone are the days when in order to find a directive one had to hunt through vast numbers of paper copies of the Official Journal which was, in any event, a documentary series that few individuals or even institutions kept. When a domestic measure, such as the MFER, cross refers to the FSMP Directive or the FSA 1990 it is now as easy to locate that directive as it is to locate the FSA 1990. As such Article 5 is, in my view, properly incorporated into the Directive.

Thirdly, the Defendant has been notified formally to the European Commission under the PARNUTS Directive as the relevant "Competent Authority" and this notification therefore operates also for the purposes of the FSMP Directive. Hence the Defendant is properly vested as the Competent Authority for the purposes of FSMPs in the United Kingdom. This, in conjunction with the incorporation of Article 5, is powerful support for the proposition that the Defendant is the properly authorised monitoring body under the FSMP Directive as transposed into English law and hence entitled to do all that it could do under the FSMP Directive.

Fourthly, the FSA 1990 – which amounts to national law within the field of the FSMP Directive - confers upon the Secretary of State a variety of wide powers of both a general and an enforcement nature which necessarily involve the Defendant in a range of "monitoring" activities. The power to monitor is a necessary concomitant of the express powers contained in the FSA 1990 and those powers could not properly be exercised if the Defendant could not monitor and form a view as to the classification of a particular product as an FSMP. In legal terms some of the powers in the FSA 1990 are expressly incorporated into the MFER by cross reference (See Regulation 7); but not all. This does not however matter for the reason set out at paragraph [118] above i.e. the duty to interpret domestic law so as to achieve the result set out in the FSMP Directive applies to all domestic legislation within the relevant field regardless of whether it was specifically adopted as an implementing measure. For instance various powers are conferred upon the Defendant under section 6 FSA 1990 which includes, inter alia, the general power of the Defendant to take over the conduct of any enforcement proceedings (See section 6(5B)). He also has the power to issue codes of practice under section 40 (after consultation). The Defendant also has the right to receive returns from food authorities with respect to their enforcement functions under section 41. He has the right to exercise default enforcement powers under section 42, and he can also direct how expenses incurred by certain food authorities may be defrayed under section 46. The Defendant could not exercise these powers, which include powers in respect of enforcement, unless he could also adopt decisions about classification.

Fifthly, there was some debate in the course of argument as to the effect of the Guidance Notes. In principle, a directive must be implemented into national law via legislation and not simply by mere changes in administrative practice or through the adoption of administrative circulars. Though as the case law at paragraphs [121] – [125] set out above demonstrates this is not an absolute rule and resort to administrative practice is permitted as a legitimate means of implementation where it does not directly impact upon private rights and/or obligations. In my view, in so far as there are interstices and lacuna in the regime they are capable of being filled and plugged by explanations and administrative practices which are set out in the Guidance Notes which expressly make clear that the Defendant can and will form a view or position on classification (see paragraphs [48] – [52] above). This is not a case where it is being suggested that administrative practice can amount to full implementation. I accept that absent such a legislative regime, Guidance Notes per se would not suffice. However, in the present case, there can in my judgment be no objection to the detailed supplementary administrative and/or bureaucratic rules which provide the flesh and bones to the legislative monitoring regime being set out in administrative practice. And this includes, as the Guidance Notes make clear, the taking of decisions on classification.

Sixthly, I should address the Defendant's alternative, domestic law, submission that in so far as there is a gap in the domestic legislation it can be filled though the process of necessary implication: See per Lord Rodger in Ward v Commissioner of Police for the Metropolis [2005] UKHL 32 paragraphs [23] – [25]. In that case the House of Lords held that as a general principle there could be implied into a statutory power such incidental powers as were necessary for its operation. The test for implication was necessity not simply that it would be sensible or desirable. In the present case if the Defendant cannot exercise monitoring powers which include the power to take classification decisions then it cannot in my view properly exercise the monitoring function which it is under a legal duty to perform and it would be in violation of EU law. As such in so far as there is any doubt about the matter then it is in my judgment necessary to imply the power so as to prevent the United Kingdom being in breach of its duty of faithful transposition (see paragraph [115] and [116] above) and to ensure that the Defendant can execute its duty effectively. I construe the legal obligation to comply with EU law as sufficient to meet a test of necessity.

In short: (a) the MFER incorporate by reference the FSMP Directive including Article 5 on monitoring and the two sets of rules must be viewed in conjunction; (b) the Defendant is the notified Competent Authority and is obliged in law to perform the monitoring role attributed to it by the FSMP Directive and MFER; (c) the FSA 1990 (which is the legislation covering the field) imposes upon the Defendant a range of tasks all of which could not properly be performed without a power to monitor which would necessarily include a power to form views and conclusions about classification; (d) to the extent necessary any gaps in the monitoring regime left by legislative measures can be plugged by administrative practice; and (e) it is, in any event, necessary to imply such a power to prevent a breach of EU law. For all these reasons the adoption of the Final Decision was intra vires.

The above conclusion does not collide with the limits on the principle of purposive interpretation (see paragraph [120] above). First, there is nothing in domestic law which contradicts the conclusion; the exercise that I am engaged in lies in filling an alleged lacuna but not in interpreting domestic law in a way which tortures and distorts its proper and sensible meaning. Secondly, in confirming that the Defendant has a power to monitor which includes a power to rule on classification there is no risk of a violation of the principles of legal certainty or non-retroactivity; this is not a case where the process of interpretation creates a criminal sanction or creates other adverse civil law consequences. Indeed the creation of the relevant criminal offence is in any event specifically catered for in the MFER.

Although my conclusion (that the Defendant has the power to take classification decisions) stands alone, some additional support is found in the decision of the Court of Appeal in R v Medicines Control Agency ex parte Pharma Nord (UK) Ltd [1998] 3 CMLR 109 (Pharma Nord) which was a case under the medicines regime. There Robert Walker LJ (as he then was) held that although under the relevant directive there was no express entrustment to the competent authority of the power/duty to decide the a priori question of classification ("…whether a particular product is a "medicinal product"") nonetheless it was a task which the competent authority should be entrusted with: "That issue is often a very complex one … and there is obvious sense in entrusting it to a specialist body with scientific expertise accumulated experience and the capacity to develop consistent policies" (ibid page 13, paragraph [54]). This conclusion, arrived at under the different but not wholly unconnected medicines regime, is one which in my view is equally apposite to the FSMP regime.

It would be idle to suggest that the MFER represents a perfect implementation of the FSMP Directive; but that is not a conclusion which precludes the Court, in performance of its duties under EU law, in seeking to make sense of the regime "so far as possible".

In conclusion, I reject the Claimant's first ground. The Defendant had the power to adopt the Final Decision and did not act ultra vires in so doing.

E. Issue II: Did the experts relied upon by the Department of Health have the relevant competence and expertise?

(i) The issue as articulated by the Claimant

It is submitted that the Defendant erred in accepting the advice of PHE and Dr Dangour because neither had the relevant expertise or competence to assess the evidence submitted by Nutricia and thereby to form a proper evaluation of that evidence against the test for an FSMP under the FSMP Directive (see the facts at paragraphs [141] – [145] below). The nub of the criticism lies in the approach adopted by PHE and Dr Dangour which, it is submitted, was that they set themselves the task of assessing each individual clinical study and research paper submitted by Nutricia to identify, whether in isolation, it proved conclusively an essential need amongst early AD sufferers for the nutrients provided by Souvenaid and failed to pay any or any proper regard to a range of relevant factors all of which pointed in a single, conclusive, direction which was that Souvenaid could provide a vital role in the dietary management of early AD. It is said that:

"…the root cause of this failure lies with the irrational decision to engage only nutritional experts, lacking any sufficient competence or any experience in the clinical management of AD, to conduct the review of Souvenaid".

In consequence, it is submitted that because of their lack of relevant expertise, the experts failed to take into account the nature of progression of AD during its early stages and how those initial symptoms (memory loss, poor appetite, needing prompting to eat, etc) could impact upon the issues under consideration which ranged from obtaining nutritional intake data for the purpose of clinical trials through to the feasibility of someone with AD being able to eat (and consistently eat) a complex diet that would replicate the nutrients he/she would otherwise obtain from a single drink of Souvenaid. The Claimant identified five allegedly material matters which it is said the Defendant's experts omitted to take into account either sufficiently or at all due to their inadequate expertise and competence. The five matters may be summarised as follows:

i) The cumulative effect of the studies and trials provided by the Claimant demonstrated that those with early AD had significantly lower levels of key nutrients, such as Uridine, and altered metabolic pathways than was observed to be the case in healthy and cognitively normal controls. Rejection of trials upon the basis that they were not randomised control trials was patently unsafe given that the proper and lawful requirement was to look at the evidential weight of the evidence in the round given that it pointed in a single and consistent direction.

ii) The experts ignored the implications of the fact that the causal connection between synapse loss and AD was uncontroversial.

iii) All of the studies submitted by the Claimant established a plausible hypothesis for the product. The experts disregarded, irrationally, in vitro tissue and in vivo animal studies. As such the Defendant (accepting that advice) ignored evidence demonstrating a concept based upon sound medical and nutritional principles in accordance with Article 3 of the FSMP Directive.

iv) Souvenaid preserved, if not increased, synapse activity and formation. This was established through clinical trials; but the Defendant's experts did not appreciate the significance of these clinical trials and were lacking in a sufficient degree of competence or experience to do so which meant that they failed to recognise that Souvenaid had demonstrated efficacy of purpose in managing the rate of decline of memory function amongst those with AD, consistent with the test in Article 3 of the FSMP Directive that a product be safe, beneficial and effective.

v) The experts ignored evidence that the clinical trials demonstrated a very high compliance rate in the taking of Souvenaid (namely 97% of those tested).

(ii) The facts relevant to the issue

The expert evidence relied upon by the Defendant and subject to this criticism are the report by PHE and the report by Dr Alan Dangour.

So far as the report by Dr Dangour is concerned he explained in his report that he was a registered nutritionist with a research background in nutritional requirements and cognitive health in later life. He was trained as a biochemist with a post-graduate MSc in Human Nutrition and a PhD in biological anthropology. He gave an account of his research activities and as to his practical experience. For example, he had conducted three randomised controlled trials to assess the effect of nutritional supplementation on health and function in later life and had conducted two systematic reviews on the effect of nutrients on cognitive outcomes in later life which included a review of B vitamins and fatty acids for the prevention and treatment of AD and dementia and the effect of Omega 3 fatty acids for the prevention of cognitive decline and dementia. The Claimant accepts that Dr Dangour has experience extending beyond nutrition, e.g. in relation to clinical trials and cognitive function but dismisses that as only "research" expertise.

At the outset of his report Dr Dangour explained that his expertise lay in generating, synthesising and interpreting epidemiological and clinical evidence in nutrition at a population (not individual) level but he accepted that he was "…not competent to assess the relevance or probative weight of in vitro studies or in vivo animal studies". Throughout his report he, quite properly, identified issues upon which (a) he did not deem it appropriate to express a view, or, (b) he was prepared to tender an opinion but considered it proper to add a caveat that his view was not within an area lying within his direct expertise. By way of illustration of an issue upon which he proffered a view but added such a caveat, he was tasked with reviewing eight studies examining the nexus between synapse loss and AD. He stated:

"The association between synapse loss and Alzheimer's Disease appears strong and consistent although this is not an area of my direct expertise".

An illustration where Dr Dangour differentiated between studies that he was asked to review based upon his expertise, was the evidence for possible increased requirements for certain key nutrients amongst sufferers of AD from "impaired/disturbed metabolism that reduced endogenous synthesis of DHA and Uridine and limits the uptake of Choline into the brain". In this regard he examined a series of studies. With regard to two of them concerning animal studies of Choline and Uridine he stated that he was not competent "…to assess their relevance or probative weight". However, he felt competent to express an opinion view with regard to the other studies and did so and his decision to express a view upon these other studies is not challenged by the Claimant.

With regard to PHE the introduction to its report states:

"Nutrition scientists at Public Health England (PHE) have been asked by the Department of Health to review scientific evidence submitted by Nutricia Limited in support of Souvenaid as a Food for Special Medical Purposes (FSMP)".

The individual scientists who performed this review are not identified in the report. Accordingly, this report may be described as an institutional report, as opposed to one attributable to individuals. Paragraph 1.4 of the Report indicates that in carrying out its review PHE instructed Dr Dangour to review Nutricia's dossier. It is clear therefore that the Report of Dr Dangour was part of the evidence upon which PHE formed its own conclusions. The approach adopted by PHE is set out in section 2 of the Report and it is not challenged as inappropriate. It provides as follows:

"2.1 When reviewing the evidence, nutrition scientists at PHE used the 'Scientific Advisory Committee on Nutrition's (SACN) framework for the evaluation of evidence' (2012) which can be found on the SACN website. The criteria used by PHE when reviewing evidence of this type are similar to criteria used by the European Food Safety Authority (EFSA). They are appropriate for making both clinical and public health recommendations as well as making recommendations for individuals and populations.

2.2 When considering the strength of evidence, type of study design has been taken into account. This is because different study designs have different strengths and weaknesses and, therefore, value in informing decisions and drawing conclusions. Good quality randomised controlled trials (RCTs) provide more reliable evidence than observational (non-intervention) studies such as case control studies. Observational studies are potentially subject to bias, confounding and reverse causality. Findings from observational studies must therefore be interpreted with caution as a range of dietary and lifestyle factors may be associated with the outcome considered. It is possible that an indicated association could be due to an unidentified factor that correlates with the studied factor.

2.3 In drawing conclusions, important factors that have been taken into consideration include: the type of study reviewed and its quality; whether the observed effects could be due to confounding factors; biological plausibility; and whether the paper has been published in a peer reviewed journal. Evidence from mechanistic studies in humans, animals, tissues or cells can only provide biological plausibility; it cannot be used as the basis for informing decisions or drawing conclusions to answer the questions above".

(iii) The extent to which the issue is properly justiciable/conclusions

I turn to the ground of challenge. In order to assess the Claimant's submission it is necessary first to consider the principles which should apply. In particular I start with a general observation, which is that in principle it may be unreasonable and/or irrational for a decision maker to rely upon the (expert) advice of a person who is not competent to perform the task of providing the advice. As such I accept that in public law proceedings questions relating to the competence of an expert advising a decision maker may be subject to judicial review.

The Courts generally are very familiar with the exercise of reviewing an expert's competence to determine whether it is appropriate that the expert should be entitled to tender evidence in a case. The task of reviewing competence is especially important in the field of criminal law where expert evidence may be adduced before juries to give an expert opinion upon matters relevant to guilt or innocence. Illustrations of the type of assessments that Courts may be called upon to perform are set out in the Report of the Law Commission "Expert Evidence in Criminal Proceedings in England and Wales" (Law Com No 325, March 2011). Although the recommendation of that Report was that Part 33 of the Criminal Procedure Rules should be amended, nonetheless it is widely recognised that the principles stated therein may in fact reflect no more than the sorts of consideration which Judges should presently apply to determine the admissibility of expert evidence: See e.g. the Criminal Practice Direction (Evidence) 33A cited at Archbold (2015) page 1484 paragraph [10-46C]. Examples of the types of assessment that a Court should make include assessing: the specific expertise of the expert to ensure that it is relevant to the issues before the Court; the impartiality of the expert; the reliability of the opinion evidence; whether the expert acknowledges that his/her opinion may be based upon information falling outside his/her field of expertise and/or whether the opinion is based upon the opinions of others. The Criminal Practice Direction Evidence 33A.5 lists a range of other substantive criteria which courts may apply to expert evidence before them. In Henderson v R [2010] EWCA Crim 1269 the Court of Appeal emphasised the importance of Courts ensuring that the subject matter of an expert opinion fell within the class of subjects upon which expert testimony was permissible and whether the witness had acquired by study or experience sufficient knowledge of the subject to render the opinion of value in resolving the issues before the Court (ibid paragraph [206]). In addition the Court identified other "checklist" factors which in a given case could be relevant including: whether the proposed expert was still in practice; the extent to which that person was an expert in the subject upon which he was going to give evidence; when the expert last saw a case in his own clinical practice; and whether the view expressed was one which was "widely held" (cf. paragraph [207]). I am not, in drawing an analogy with criminal law practice, suggesting that these considerations necessarily apply in the same way to the selection of an expert and reliance upon expert advice by an administrative decision maker. They do, however, serve to demonstrate that Courts are familiar with the task of assessing the appropriateness of expert evidence for the purpose of legal tests and they reinforce the point that issues going to competence are readily justiciable.

A second general observation to make is that the choice of expert is one that falls prima facie within a decision maker's margin of appreciation. This is an important difference between the task of a Court in (say) criminal proceedings and in judicial review. In the former a Court acts as a gatekeeper to evidence which goes to the decision making jury; in the latter the Court is exercising an ex post, appraisal of the rationality of a decision by a person or body which may itself possess expert skills. The Court must therefore exercise care in avoiding a conclusion which in substance second guesses the choices of the administrative decision maker. But this does not mean that the Court will not supervise those choices and ensure that certain minimum requirements are met. The issue in each case will be where and how the balance is to be struck.

In the present case I have come to the conclusion that the Defendant did not err in relying upon the evidence of PHE and Dr Dangour. This is for the following reasons which reflect my conclusion as to the balance to be struck between an appropriate standard of review and the margin of appreciation to be accorded to the Defendant.

Relevance of qualifications to the exercise conducted under the FSMP Directive: The first task is to compare the expert's qualifications with their allotted task. It is necessary in this regard to examine the position of PHE and Dr Dangour in conjunction. As to this, both PHE and Dr Dangour had relevant qualifications which were appropriate to the task. The specific task is that laid down in Article 1(2)(b) in the light of Article 3 of the FSMP Directive. These have been set out at paragraphs [41] – [43] above. It is, in my judgment, clear that at the very least a significant part of the relevant evaluation engaged the skills of a nutritionist. To take an extreme example it would be irrational for the Defendant to instruct a mathematician or a quantity surveyor to assess whether Souvenaid met the definition of an FSMP. Such persons do not have skills even loosely relevant to the requisite statutory task. However, the statutory task includes and necessitates significant nutritional assessments and it was accordingly within the discretion of the Defendant to choose experts within that field who, for example, might be nutritionists who were able to express nutritional and related clinical views, or, medical clinicians who were able to express nutritional views. Equally it would have been rational to choose either pure nutritionists or pure medical clinicians provided that the decision maker could fill any gaps in the advice tendered. Article 3 of the FSMP Directive requires formulation to be based on "sound medical and nutritional principles". It seems to me to be clear that the skills of a nutritionist were thus expressly called upon in substantial part to perform the evaluative exercise required by the legislation. In the present case Dr Dangour has explained his skills and the limitations thereupon. He has general nutritionist expertise and some direct expertise in later life, and, clinical trials. The Claimant does not dispute that he has both skills but says that it is inadequate to have only research skills in clinical trials. His Report formed part of that of the PHE. They have explained their remit and the process they applied to the review. The Claimant has not sought disclosure of the CVs of the individuals who undertook the review on behalf of PHE. If disclosure had been given and it revealed that the individuals concerned had no relevant experience then the Claimant might have fared better with this argument. However, in the absence of any challenge to the particular skills of those individuals who performed the review, it is insufficient to contend, in the abstract, that a body such as PHE is ill-qualified to perform the task in issue. As an institution, the PHE must be taken at least prima facie to posses the necessary evaluative skills. So far as Dr Dangour is concerned his Report was incorporated into that of PHE. And there is no doubt but that the admitted limitations upon his competence were known to PHE and there is no evidence that they were not taken into consideration. Viewed as a whole Dr Dangour and PHE had relevant expertise.

Relevance of qualifications to the impugned reasoning: Secondly, and importantly, it is also necessary to consider the Claimant's criticisms when measured against the specific reasons for rejection contained within the Final Decision and the scope of the instructions given to the experts (see paragraph [99] above). There are two reasons given for rejecting Souvenaid as an FSMP. They are, in their essential nature, nutritional reasons relating to (a) a patient's nutritional intake prior to inclusion in a clinical trial ("the intake point") and (b) the extent to which nutritional needs can be met through diet modification ("the modification point"). The Claimant has not, specifically, linked the generalised criticisms they make of the qualifications of PHE and/or Dr Dangour to these two very particular reasons both reflected in the expert's instructions. Both reasons are embedded, in substantial part, in considerations which in my view a nutritionist could have made. I thus see considerable force in the Defendant's submission that the real issues in dispute which arise from the Final Decision fell squarely within the expert's competence. The gist of the Claimant's case is that PHE/Dr Dangour "dismissed" Nutricia's medical evidence. However, the decision letter does not say that this evidence has been dismissed or rejected. The letter focuses upon other matters and it is these other matters that need to be examined in the light of the Claimant's criticism (see more generally on this point Section F. below).

The inherent expertise of the decision maker: Thirdly, it is relevant also to consider the inherent skills of the decision maker. In some cases, for example in a criminal trial, the decision maker is a lay jury about whom it is not possible to make an assumption that they have any requisite expert skills. The same is not true of the Defendant. The Defendant is a skilled decision maker and has been notified to the Commission as the Competent Authority. This is relevant because a skilled decision maker can itself assess the strengths and weaknesses of any reviews and reports and opinions submitted to it by its instructed experts. By way of illustration only, the Defendant relies upon witness statements from Dr Trudy Netherwood. She explains in her evidence that she has a doctorate in biological sciences and has experience of working within the NHS and within commercial and research organisations. She also rejected the suggestion made by the Claimant that the Defendant had in effect slavishly followed the experts' reports without exercising independent evaluation. In a case where the decision maker is able to appraise the strengths and limitations of advice given to it then any shortfall in the expert's advice can be catered for. It would hence only be if the Claimant could show that the decision maker had accepted without independent judgment the advice of a person who was not fully qualified to express that opinion and advice that a causal connection could be established between the lack of competence of the expert and the ultimate decision taken. There is no such evidence in the present case.

The extent of the evaluative judgment: Fourthly, it is relevant to take account of the extent of the evaluative judgment inherent in the exercise and its nature and the margin of appreciation that must be accorded to the decision maker. The present case does not involve any broad "macro" policy questions. The issue is a narrow self-contained issue involving specific questions of fact against a legal definition. In my view this means that the Defendant does have a margin of appreciation but it is not at the most generous end of the spectrum where a Court is bound to accord to the decision maker the widest possible latitude and deference. On the other hand, the issues remain technical and scientific and there may well be scope for more than one legitimate view. Moreover, the decision impugned lies in the field of health protection and consumer protection. This is because if a patient erroneously takes a food assuming it is medically beneficial then that risks distorting the patient's proper diet, possibly to their medical detriment. This indicates that the courts will accord to the decision maker a discretion to adopt a precautionary decision. In my judgment, before I could conclude that the Defendant erred in relying upon advice from PHE and/or Dr Dangour, I would have to be satisfied that the choice of these experts fell outside the ambit of their legitimate margin of appreciation. In my judgment, the Defendant was well within the margin of appreciation in selecting the combination of PHE and/or Dr Dangour to provide advice.

For these reasons, I do not accept the criticism that the competence of the experts relied upon by the Defendant was inadequate and that the Defendant acted unlawfully in taking it into account.

F. Issue III: Did the Department of Health act perversely or irrationally in rejecting the evidence of the Claimant?

(i) The provisional nature of the issue

This issue focuses upon the merits of the Final Decision on the "intake point" and the "modification point". In relation to these issues I have concluded that the Defendant acted lawfully. However, this is upon an assumption that the test in law applied by the Defendant to these issues was the correct one. And as to this it seems to me that the challenge by the Claimant to the approach adopted by the Defendant highlights important points of law which for reasons set out elsewhere (see Section H below) I should refer to the Court of Justice. I limit the analysis in this section therefore to an assessment of the Claimant's submission upon the presumed basis that the test applied by the Defendant is correct.

(ii) The scope and nature of the review process

It is important to focus upon the key reasoning of the Defendant. This is because the Claimant has adduced a substantial body of expert evidence before the Court which was not before the decision maker and was not therefore taken into account. This new evidence confronts head-on the correctness of the conclusions reached by Dr Dangour and PHE. I am, in effect, invited to treat the Defendant's decision as wrong upon the basis that it is perverse and irrational when viewed in a context which includes this new evidence. I therefore need to start by making some general observations about the standard of review and margin of appreciation and the process that I propose to apply to this particular exercise.

First, this being a judicial review it is necessary to focus upon the Defendant's actual reasoning. The specific rationale behind the rejection of Souvenaid as an FSMP is relatively narrow and focuses upon two points only: the intake point and the modification point. The dispute on the "intake point" and the "modification point" is, in substance, one of principle not fact. The attack launched by Nutricia however goes far and wide and beyond these two points.

Mr Henshaw QC, for the Secretary of State, sought to explain quite how narrow the dispute in truth was and therefore he submitted that the Claimant's criticisms were hence irrelevant. He stated in relation to the intake point that the original claim made by Nutricia for Souvenaid was that the product was "…intended to be taken as a supplement to the normal diet". The Defendant thus reviewed Souvenaid upon the basis that it was appropriate for those patients who enjoyed a normal diet. Mr Henshaw QC also took me to the evidence which established that the studies relied upon by Nutricia did not establish the original or initial intake of the patients who were the subject of the studies. As such there was no unambiguous evidence that Souvenaid did any more than restore a patient's nutrient or mineral levels back to par or "normal"; as opposed to improving the situation of a patient with a normal/par diet. This was the explanation behind the Defendant's decision that the evidence submitted did not establish a "special nutritional" requirement. Mr Henshaw QC also explained that in relation to the "modification point" there was no really serious challenge to the facts as found by the Defendant. In particular the Claimant does not submit that for patients for whom they say Souvenaid is appropriate it may be impossible to modify their diet (for instance by increasing the intake of supplements). He points out that the nub of the Claimant's case is that a product is an FSMP if a clinician considers that Souvenaid is appropriate and diet modification is not sufficient for the patient in question. As such the dispute was more one of principle than of fact.

Against this backdrop, the criticisms contained within the Claimant's evidence ranged far wider than the two reasons referred to above. They focus upon the Claimant's case about the inherent merits of Souvenaid. In the course of his opening submissions Mr de la Mare QC, for the Claimant, advanced six propositions which he claimed were common ground. These were: (i) that Souvenaid was a food; (ii) that it was safe; (iii) that it was clinically effective in the dietary management of AD sufferers; (iv) that Souvenaid produced very high rates of patient compliance (c. 97%); (v) that Souvenaid had no useful or meaningful role in a healthy population because a key component (Uridine) is not needed by healthy adults; and (vi), that Nutricia wished to sell the product only under medical supervision. In the course of argument I asked Mr Henshaw QC whether the Defendant agreed that Souvenaid was clinically effective (item (iii) above). Mr Henshaw QC, on behalf of the Secretary of State, did not agree. His position was that the reason for rejecting Nutricia's application was that it did not meet the test for an FSMP for the two reasons identified above (the "intake point" and the "modification point") and the Defendant's conclusion therefore applied even if the Claimant was correct and prima facie Souvenaid had the benefits claimed for it. He did not therefore accept that Nutricia's evidence had been rejected or dismissed. In essence, the Defendant says that it has not formed a final view on the merits of Nutricia's medical claim that patients who took the product improved because in the Defendant's view the baseline for the improvement was not known. However, in large measure the Claimant's claim about general improvements was actually accepted. He pointed out that:

(i) PHE took the view that pre-clinical data (i.e. animal and in vitro studies) could provide biological plausibility, for example for a hypothesis, but could not in and of itself establish that people with early AD had particular nutritional requirements (PHE Report at paragraphs [3.3.1], [3.4.2] and [3.51.1]. The scientific relevance of pre-clinical data was, to provide biological plausibility, i.e. to support the plausibility of a hypothesis, which then needed to be tested in clinical trials on humans. Mr Henshaw QC explained that the Claimant's expert, Dr Passmore, essentially concurred with this analysis when he stated in his report that the animal studies "… provide[] a strong rationale to study Souvenaid in people with AD …" and he also pointed out that another expert for Nutricia, Dr Allison, had stated in his report (in relation to the "Mi review"): "In my opinion the literature reviewed in these publications provides a strong basis for testing a nutritional approach to early AD";

(ii) Moreover, there is evidence of a meeting between PHE and Nutricia in which Dr Tedstone of PHE (who led the PHE review) indicated that she accepted that Nutricia had made out a plausible hypothesis. The Note of the meeting records: "You have a plausible hypothesis. I'm not being dismissive. Animal data makes it plausible. Be careful about leaping on to cause and effect." Similarly, the PHE report at paragraph [3.92.2] accepts that the pre-clinical/animal studies in section 6 of the Nutricia dossier provided background evidence regarding the role of certain nutrients in the formation of synapses and PHE did not doubt or question that AD was a disease involving synapse loss (PHE paragraph [3.25.1]).

It is unnecessary for me to decide as to the exact extent of the agreement or disagreement between the parties on this clinical evidence. What is important is to identify and analyse the reasons in the Final Decision.

Secondly, in terms of margin of appreciation I have set out the starting point in paragraph [153] above, namely that this is not a case of a broad macro policy but, rather, is a narrow question of fact and law involving evaluation of technical evidence. In Pharma Nord (ibid) at paragraphs [57] – [58] Lord Justice Robert Walker observed, in the context of the classificational question as to what was or was not a medicinal product, that this was a "hard-edged question" to which there was in theory only one correct answer however difficult it may be to arrive at but that (citing in support R v Monopolies & Mergers Commission ex parte S Yorkshire Transport [1993] 1 WLR 23 at page 32):

"…this clear-cut approach cannot be applied to every case, for the criterion so established may itself be so imprecise that different decision-makers, each acting rationally, might reach different conclusions when applying it to the facts of the given case".

Lord Justice Robert Walker then stated:

"[58] That observation applies with greater force to the task of identifying a medicinal product within the meaning of the 1994 Regulations. In borderline cases it is a very difficult task, and one which the MCA is better equipped to undertake than the court. The criminal court is obliged to address it if it is raised by way of a defence to a prosecution, but the civil court is not under the same obligation and should be wary of entertaining it".

I do not view this as inconsistent with this Court adopting a relatively close and detailed review of the issues arising on this judicial review. In my judgment the High Court is able to: (a) identify and supervise the specific reasoning in the Final Decision; (b) consider whether the reasoning was consistent with the relevant legal test; (c) consider whether the Final Decision omitted to take account of relevant evidence; (d) consider whether the conclusions drawn by the decision maker flow from evidence which the Defendant accepted as relevant and admissible and were within the range of inferences which could properly/reasonably be drawn; and (e), consider whether the Claimant was given a fair chance to submit evidence.

If, however, the argument advanced to the Court is essentially that the Claimant's expert evidence is right and the Defendant's expert evidence is wrong then, save in the case of a manifest error, the Court should not interfere. Indeed the very process of a judicial review is not conducive to the Court being in a position to form a definitive conclusion on the intrinsic merits of such a case. I have not heard oral evidence from the experts nor was I invited to. Submissions on the correctness of the Claimant's evidence formed a relatively small part of the submissions made and the forensic process undertaken did not permit me, in any effective manner, to form a view as to the merits or demerits of the conclusions of any particular expert. For example, the Claimant's expert evidence focused upon the conclusions of the Defendant's experts about a wide array of underlying studies and pieces of scientific and medical literature. For the Court to form a view on the merits would accordingly have entailed not only a consideration of the headline opinions of the experts but also a detailed review and understanding of that extensive underlying literature. This is not an exercise that I was asked to undertake and more pertinently it is not one it would be appropriate to express a view about given the strictly limited nature of Defendant's reasons.

With these general observations in mind I turn to consider the two reasons given for the Defendant's conclusion that Souvenaid was not an FSMP.

(iii) The intake point

As set out above one key part of the Defendant's reasoning, in the Final Decision, was that Nutricia had not established, in its evidence, that the intake of those who were subject to clinical and other studies, was normal or "par".

The conclusion I arrive at is that if the Defendant is correct in law that the benchmark for proof of the benefit or efficacy of Souvenaid is an early AD sufferer with a healthy (normal) diet then on the facts the Defendant was squarely within his margin of appreciation to conclude that Souvenaid was not an FSMP. I also find however that this issue raises an important point of law which should be referred to the Court of Justice. In the course of submissions I was taken through the various experts' reports which, in my view, established that the Defendant's conclusion was indeed the true evidential position. There is no real dispute here: the Claimant's expert evidence as submitted to the Defendant in support of the notification process did not address this issue.

Mr Henshaw QC pointed out that the premise upon which Souvenaid was notified to the Defendant was that it was a product intended for those with a "normal" diet. As such if, in actual fact, the evidence upon which Nutricia relied involved patients who were not taking a normal diet and for whom Souvenaid had the consequence of simply bringing them up to the level of a normal or "par" diet then this would not prove the notified claim made for Souvenaid which was an improvement beyond the normal. Confirmation of the above position is found in Table 1 to the Nutricia notification under the heading "How Souvenaid meets the FSMP criteria". In relation to the definitional requirement that the product be for patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically determined nutrient requirements, Nutricia explained that patients with early AD had: "…increased nutrient needs in order to support the metabolic Kennedy pathway for phospholipids formation, leading to the formation of neuronal membranes and synapses". The reference to "increased" needs was understood by the Defendant to be a reference to needs over and above those satisfied by a normal diet.

In her Witness Statement on behalf of the Defendant Dr Netherwood explained the rationale behind the Defendant's concerns about dietary intake:

"The lack of any information regarding the dietary intake of the population group in studies was particularly problematic, as it made it impossible to conclude whether people in the study had reduced nutrient levels because they were not eating a healthy balanced diet or because of a disease mechanism. One of the risk factors for Alzheimer's Disease is not eating a healthy balanced diet. I am aware that Nutricia have now suggested that the difference in nutrient levels may be caused because people with early AD would forget to eat a healthy balanced diet unless prompted to do so. Even if that were the case, it would not make their product an FSMP. Individuals who need prompting to eat could be supported in a number of ways to improve nutrient intake, but such interventions would not be FSMPs.

If a product is an FSMP it can be marketed with the phrase "for the dietary management of [the particular medical condition]". It is supposed to apply to all patients with that disease rather than being something which a clinician might decide, on a case-by-case basis, could perhaps benefit their patient. There is of course nothing to prevent a clinician from prescribing a specific diet, food supplements or fortified foods to patients on a case-by-case basis which they think might have some benefit on a particular patient, but this does not mean that those diets or products are FSMPs.

The key aspect of the definition of a FSMP is the dietary management indication, which is a specific indication for a group of patients that need that specific nutrient source. It is not intended to be a product that is convenient to replace other foodstuffs, even though it appears that some clinicians may be using them in this way. The use of products for a particular purpose is a clinical decision; however the marketing of a product for a particular purpose is strictly regulated".

There does not appear to be much doubt about the nature of the dispute between the parties. Professor Allison, who produced expert evidence for the purpose of these proceedings for the Claimant, did not dispute the Defendant's evidential conclusion, only its relevance. He acknowledged in his report that evidence on intake did not exist, but his point was that this was irrelevant (cf. paragraph [5.6]):

"Patients with AD have been found to have significantly lower plasma and brain levels of DHA and Uridene, most probably for metabolic reasons, and of folate and vitamins B, B12, C, and E, despite apparently consuming a diet with sufficient energy and protein to maintain Body Mass Index in the normal range. A cluster of vitamin deficiencies like this is most likely to be due to any other cause than inadequate intake. The reports by PHE and Dr Dangour dismiss these studies because data on dietary intake was not obtained. This is difficult to obtain in AD patients due to impaired cognitive function, but the absence of such data does not negate the fact that low levels of the above nutrients, whether caused by reduced dietary intake or a reduction in the ability of the liver to metabolise certain nutrients, pose a potentially significant problem for reasons which have been outlined above".

Professor Allison concluded that a plausible case had been made for the designing of food to counteract the metabolic problems that he described but that the experts relied upon by the Defendant had considered the issue "…too narrowly in terms of dietary intake rather than in the light of the totality of evidence available, including all the metabolic data". Professor Allison concluded that the Defendant's approach might be appropriate in population studies with implications for public health policy but was inappropriate for clinical problems with multiple contributory factors such as AD.

In similar vein Professor Silk also produced an expert opinion for the purpose of this litigation on behalf of the Claimant. He accepted that "very few" of the studies relied upon had addressed the "intake point" but he took the view that the Defendant's control premise was "flawed". He stated, in a part of his report devoted to a criticism of the analysis undertaken by PHE:

"10.5 Moreover, the court ought to be aware that it is my opinion that the methodology of PHE and Dr Alan Dangour is flawed.

10.6 The PHE review focuses upon answering the question "Do people with early AD have special nutritional requirements?"

10.7 Very few of the studies submitted by Nutricia set out to answer this question. Again and again PHE conclude that the studies are flawed because they contain no information on nutritional intakes. It is hard enough to ensure that patients with early AD consume 125ml from a carton per day, let alone compose scientific valid food charts for rigourous nutritional analysis.

10.8 There are frequent references in the PHE Report to the fact that there are only special nutritional requirements in AD because of malabsorbtion. Nobody is suggesting that early AD patients have malabsorbtion – the suggestion is that at least in part low levels of Kennedy Pathway substrates and cofactors in plasma and brain occur because of increased utilisation of neuronal membrane synthesis to keep pace with the synaptic loss that is the hallmark of the pathophysiology of early AD.

I believe therefore that the premise of the PHE and Dangour review is flawed and that the conclusions in no way militate against Souvenaid being classified as an FSMP".

In view of the above it seems to me that the correct analysis of the situation is as follows. The Final Decision rejected the classification of Souvenaid as an FSMP upon the basis that the evidence submitted in support did not establish the intake of those patients who were the subject of the studies relied upon to advance the claims for Souvenaid as an FSMP. If the Defendant's legal premise is correct then there is in my judgment no doubt but that Nutricia's evidence did fall short. The original notification of Souvenaid was upon the premise that it improved the situation relative to a normal diet. The Defendant did not therefore act irrationally or perversely in refusing to classify the product as an FSMP upon the basis that the supporting evidence did not establish this basic premise.

It could well be that the case reflects the position of two ships passing each other in the night. It is not apparent that in notifying Souvenaid upon this basis that Nutricia had specifically addressed itself to the implications of this particular problem. However, this became a key issue for the Department and that stance was made clear in meetings between the Defendant and Nutricia.

The question which now arises is whether the Defendant's starting premise is correct. This is a narrow issue. It essentially poses a question of principle and law which is whether it is necessary for a product to be classified as an FSMP that it is beneficial against a benchmark of a normal diet, or alternatively, whether it suffices for it to be beneficial against a benchmark of an abnormal/inadequate diet.

This is a question which it is appropriate to pose to the Court of Justice.

(iv) The modification point

The second reason advanced in the Final Decision by the Defendant for rejecting the classification of Souvenaid as an FSMP was that even if patients with early AD were to have a special nutritional requirement as maintained by Nutricia this could be met by modification of the normal diet, by other foods or particular nutritional uses or by a combination of the two. As such the test in Article 1(2)(b) has not been met.

Once again if the Defendant is correct in its interpretation of the law then there is little doubt but that its decision was rational. If the test is strict and an FSMP is, in effect, a residual categorisation which does not overlap with supplements or fortified foods then it is not argued by Nutricia that in all cases of early onset AD such supplements or fortified foods would not suffice. Equally, it is not said by Nutricia that if the test is such that an FSMP is excluded whenever an AD sufferer's diet could be improved (even absent supplements or fortified foods) by altering a normal diet that Souvenaid would then qualify as an FSMP. The real issue is as to the correctness of the legal test that was applied. And once again I consider there to be an important issue of law for the Court of Justice to resolve. The Claimant challenges the Final Decision upon the basis that it adopts an overly strict test. It wrongly seeks to imply additional words and meaning into the definition of an FSMP. The Claimant also criticises the Defendant's position as wrongly requiring a focus upon a generalised and abstract use of foods, food supplements and/or fortified foods as a potential replacement for an FSMP. The Claimant submits, to the contrary, that properly construed the definition of an FSMP focuses upon the particular patient with particular needs under particular medical supervision. It emphasises that the choice of an FSMP is or should be a medically led and supervised step and will involve, in many instances, the clinical choice of Souvenaid over an alternative approach to diet on a patient specific basis. The Claimant accepts that in practice it will be "very rare" that an FSMP is the only way to provide certain nutritional requirements to patients (indeed on their website Nutricia claim only that it is "difficult" to obtain the relevant nutrients from elsewhere; they do not say it is impossible). They point out that from a clinical perspective for patients suffering from disease related malnutrition it may be appropriate to prescribe an FSMP but, in other instances, it may suffice simply to give the patient a diet plan or diet advice. The gist of the Claimant's criticism is that it is wrong: "…to answer such questions axiomatically and by reference to the treatable cohort as a whole…e.g. to ask the question for all sufferers of all forms of malnutrition…". Instead it is submitted that the definition of an FSMP must include an assessment of medically identified, and individualised, nutritional needs for particular patients.

The Defendant, for its part, points out that an FSMP is a classification of, in effect, last resort. The insertion of the relevant words about modification in the definition of an FSMP are intended to ensure that a product cannot be classified as an FSMP if the patient's needs may be met by other dietary supplements or fortified foods. This creates a clean line of demarcation between the various categories of product and the different regimes. It prevents manufacturers from self-certifying products with the advantageous classification of an FSMP in order to obtain commercial advantages when, in truth, they should properly be categorised as supplements or fortified foods. The Secretary of State denies that this hinders good clinical judgment because nothing prevents medical professionals recommending the use of Souvenaid. The case turns upon what the permitted marketing claims are; not clinical judgment. The Defendant thus rejects the criticism made as being essentially arbitrary and lacking legal certainty. The essence of an FSMP is the right to make specific medical claims; but if the Claimant is correct Souvenaid could be marketed with broad medical claims even where such claims would not be true.

For the reasons given above this issue raises a question for reference to the Court of Justice.

G. Issue IV: Does the Final Decision amount to a breach of Article 34 TFEU?

(i) Articles 34 and 36 TFEU

Finally, the Claimant submits that the Final Decision amounts to a contravention of Article 34 TFEU. That provision is contained within Chapter 3 of the Treaty on the Functioning of the European Union ("TFEU"). It provides:

"Article 34

Quantitative restrictions on imports and all measures having equivalent effect shall be prohibited between Member States".

There is no material dispute between the parties as to the relevant legal principles. I can summarise them briefly.

The prohibition in Article 34 applies to all measures which directly or indirectly hinder intra-Community trade. There is no de minimis threshold which has to be met; but a measure will not engage the prohibition unless it is "capable" of hindering or distorting trade between Member States. That effect can be direct or indirect and actual or potential. In a case involving an allegation under this article it is necessary to identify (i) the measure in question; and (ii) how it is "capable" of hindering imports in the manner described.

It is common grounds that in principle Article 34 is capable of applying to rules on the marketing of goods, even if those rules are applied without distinction to domestic and imported goods alike.

Article 36 TFEU provides for circumstances where measures which are otherwise prohibited may be justified. It provides:

"Article 36

The provisions of Articles 34 and 35 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants; the protection of national treasures possessing artistic, historic or archaeological value; or the protection of industrial and commercial property. Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States."

Where a restriction applies without distinction to domestic and imported products alike then, in addition to the factors identified in Article 36, a Member state may also seek to justify a measure upon other essential requirements of policy. Article 34 TFEU is directly effective i.e. it can be relied upon as sword or shield in national proceedings against the State and the national court has a duty to ensure that the prohibition is given full effect to.

(ii) Claimant's submissions

Nutricia puts the case under Article 34 TFEU in the following way in its Detailed Statement of Facts and Grounds:

"The effect of the DoH's Decision is to create [a] dual burden. It has the effect of precluding Nutricia, which manufactures Souvenaid in another Member State (the Netherlands) and lawfully markets Souvenaid as an FSMP in seven Member states (Austria, Belgium, Germany, Italy, Ireland, the Netherlands and Spain) from marketing this product as an FSMP in the United Kingdom. The effect is to create a restriction on the free movement of Nutricia goods within the Union, contrary to Article 34 of the TFEU".

Nutricia also argues:

"… the DoH have adopted a procedure which goes far beyond that provided in the FSMP Directive, as applied by seven other Member States where Souvenaid is lawfully marketed. The consequence is the Decision the effect of which is to seek to restrict trade in Souvenaid in the UK."

It is further contended that at no point has the Defendant sought to justify the measure upon the basis of Article 36 or upon any other grounds. Nutricia cites the judgment of the Court of Justice in Case C-446/08 Solgar Vitamin's France v Ministre de L'Economique de Finance at de L'Emploi [2010] ECR I-3973 for the proposition that where a Member State seeks to justify a restrictive measure (in casu in the field of food supplements) it has a high burden of proof and must act proportionately:

"54. In exercising their discretion relating to the protection of public health, the Member States must comply with the principle of proportionality. The means which they choose must therefore be confined to what is actually necessary to ensure the safeguarding of public health or to satisfy overriding requirements regarding, for example, consumer protection. They must be proportional to the objective thus pursued, which could not have been attained by measures which are less restrictive of trade within the European Union (see Commission v Denmark, paragraph 45, Commission v France, paragraph 52, and Commission v Germany, paragraph 87)."

55 Furthermore, it is for the national authorities to show in each case, in the light of national nutritional habits and in the light of the results of international scientific research, that their rules are necessary to give effective protection to the interests referred to in Article 30 EC and, in particular, that the marketing of the products in question poses a real risk to public health (see, to that effect, Commission v Denmark, paragraph 46, and Commission v France, paragraph 53).

It is said in this regard:

that there are no health concerns or risks associated with Souvenaid that have been raised;

that the DoH approach lacks transparency and fairness; and,

that there is "no room for Member States discretion" since this is an area that is harmonised at EU level and in effect EU law requires member states to respect the classification and interpretation adopted by seven other Member States

In the final analysis Nutricia sought to advance its case under Article 34 TFEU on the basis of an alleged failure by the Defendant to apply mutual recognition to the decisions adopted in other Member States.

In the skeleton argument however Nutricia cross refers to the Grounds but then proceeds to develop the submission in two ways which were not covered in the Grounds.

First, it is said that the Defendant has denied Nutricia a merits based assessment of Souvenaid in the context of Drug Tariff and reimbursement considerations regardless of the formal classification of the product as an FSMP. During the oral hearing the Claimant provided me with a detailed chronology seeking to show that the ACBS had deferred making any assessment pending a resolution by the Defendant of the classification of Souvenaid. Secondly, it is now said that the ACBS has acted unlawfully and disproportionately in that it has also refused to process an alternative case advanced for Souvenaid which was that it should be treated for Drug Tariff purposes as a food supplement. In its skeleton argument served before the hearing Nutricia submitted:

"149. A national policy or approach that denies merits-based assessment, and thus access, to a national health service reimbursement system of disputes about classification alone (rather than, say, concerns about safety, or health claims made to the public), for a product with a prima facie case of efficacy is manifestly an unjustifiable restriction on the Claimant's directly effective right to the free movement of goods derived from Article 34 TFEU:

149.1 The principal legal significance of the Decision (which cannot bind food authorities) lies in the fact that it constitutes and is intended to constitute a bar to Souvenaid being assessed by the ACBS. It is as such a restriction for the purposes of Article 34 TFEU. The ACBS have made it clear that they will not make a decision in relation to Souvenaid whilst its status remains the subject of judicial review, not least because if the product is a mere food supplement for which no disease-specific or disease related claim can be made, it cannot attain Part XV approval (since the products in Part XV are listed on a "by disease/condition" basis).

149.2 In terms of potentially legitimate aims, there is no public health justification for the refusal to assess Souvenaid on its merits for reimbursement on the NHS (not least since the acceptance by the Claimant of FSMP status entails marked restrictions on how the product is sold and marketed), whilst the debate on classification is settled by this Court.

149.3 The effects of such restriction are self evidently disproportionate".

When it came to oral argument the case focused upon the allegation that the ACBS had acted unlawfully in refusing to process Souvenaid as a food supplement, and little weight was placed on the case as formally advanced in the Grounds but they were certainly not abandoned.

(iii) Analysis: Nutricia's formal case

I propose to deal with Nutricia's formal case first, then consider the new case as it evolved. I am unable to accept the case formally advanced by Nutricia. There are a number of reasons why this is so.

First, it is simply unproven that any conduct by the Defendant has any effects which could be said to take it into the realms of Article 34 TFEU. The Defendant has made clear that its "view" as expressed in the Final Decision was not binding. It is clear that Nutricia still markets Souvenaid in the United Kingdom as an FSMP notwithstanding the negative position adopted by the Secretary of State. The Defendant has no power to prohibit marketing; only a successful prosecution will achieve that. Nutricia has advanced no evidence at all to show that imports have thus been affected or could potentially be affected in any way. It remains Nutricia's view that it is entitled to market Souvenaid as an FSMP, that the Defendant has no power to prevent it from so acting, and that it will not in actual fact be deterred from so acting. The Final Decision serves to put Nutricia on notice that the Defendant disagrees within its analysis and if the Court of Justice agrees with the Secretary of State then Nutricia might have exposed itself to a successful criminal law prosecution; only time will tell. But if that is so and Nutricia is successfully prosecuted then Nutricia will have acted illegally and any deterrent impact upon trade flowing from a conviction in criminal proceedings will be inherent in the FSMP Directive and/or wholly justified in the name of public health and consumer protection.

Secondly, the case as advanced in the Grounds was based on mutual recognition being the requisite norm. However, this is a not a principle that is set out in the FSMP Directive nor is it one accepted as correct by the EC Commission (see paragraph [94] above) and during argument Nutricia did not in actual fact press this point. As set out above Nutricia's position has quite fundamentally altered direction and shape and focused upon a constructive refusal by the ACBS to address the position of Souvenaid under the Drug Tariff.

Thirdly, there is, in any event, no evidence before the Court as to the actual effect of the alleged measure (the Final Decision) on intra-EU trade. Whilst I accept that the threshold for proving an impact upon intra-EU trade is relatively low (direct or indirect, and actual or potential) nonetheless there is a minimum level of evidence needed to show the causative impact upon trade. In some cases this might be obvious and a court can very readily draw an inference that the impact is obvious. However, this is not such a case. The alleged "measure" impugned is an individual decision in an individual case and the challenge is not to the system as a whole or to domestic regulations or legislation. Further, the "measure" therefore only affects the marketing claims that may be made for Souvenaid as a medical food. The measure does not prevent marketing the product as an ordinary food or a supplement nor does it prevent medical professionals recommending Souvenaid and nor does it prevent Souvenaid being sold in health shops. At its highest the "measure" has a strictly limited effect. All of this being so it is incumbent upon the Claimant to show how that limited fettering of marketing freedom impacts, causally, upon imports. For instance does the inability to market using the few additional words that Nutricia wishes to use cause (actually or potentially) a volumetric/quantitative reduction in sales into the UK, and, if so, by how much? As with other EU trade rules (such as the state aid rules) Article 34 TFEU can have a very serious impact upon national laws and practices if applied by the courts and the courts should accordingly ensure that they are satisfied that the conditions for the application of the prohibition are properly made out before granting an application for relief thereunder: See for a similar expression of concern in the context of the state aid rules: R (British academy of Songwriters, Composers and Authors) et ors v Secretary of State for Business Innovation and Skills [2015] EWHC 1723 (Admin) paragraph [300]. In the present case there is no evidence before the Court upon which I can safely express the view that Article 34 TFEU has been violated.

(iv) The new case: Alleged delay in processing Drug Tariff decisions

I turn now to consider the alternative way in which the case has been put. My starting point here is to consider whether I should entertain this argument at all. I am not in this regard seeking to apply an overly technical, pleadings driven, approach to the case. I am however concerned that the way in which the argument is now advanced was not in the original Grounds and only emerged in the skeleton argument and then, more fully, by way of supplemental written elaboration during the hearing itself. If the point arising was purely one of law or, alternatively, involved only a very limited dispute about facts which the Secretary of State could address, then I would not be overly concerned, provided the Secretary of State was given a fair chance to address the issues arising. However, as matters stand the case now turns upon an alleged delay in the ACBS forming a view about Drug Tariff classification for Souvenaid as either an FSMP or a food supplement. There are in my view real problems with adjudicating upon this new argument.

First, the Final Decision does not address this issue and, for that reason, the point was never canvassed in the Claim Form or Grounds and hence not addressed by the Defendant in its Defence. It now therefore emerges as a challenge to an entirely new and different decision which is framed in terms of a wrongful omission (an alleged refusal to take a decision under the Drug Tariff) whereas the original challenge is said to be an unlawful act of commission (i.e. the taking of a decision on Souvenaid under the FSMP Directive). The case is thus now fundamentally different.

Secondly, it follows that the Secretary of State has not in formal pleadings or in evidence addressed this. There is no evidence which explains in detail how the Drug Tariff works and, more importantly, how it applies to Souvenaid or as to the impact that a decision is likely to have on the financial or other performance of Souvenaid in the market place. As such there is no explanation of how or why in causal terms a decision in relation to Souvenaid under the Drug Tariff as either an FMSP or food supplement could or would affect imports. In this regard I make the same points as I have made about evidence at paragraph [197] above.

Thirdly, although the challenge is now levelled at the ACBS, that body has no identity distinct from that of the Defendant. It is an ad hoc body which advises the Defendant under the Defendant's organisational umbrella. As such on analysis the decision now challenged would seem to be an alleged failure by the Defendant itself to form a final view on Souvenaid for Drug Tariff purposes. As to this the Secretary of State has confirmed to the Court that (a) it is deferring a decision on Souvenaid as an FSMP under the Drug Tariff pending resolution of this issue in law and (b) with regard to Souvenaid as a food supplement Nutricia made an application to the ACBS on 12^th September 2014 but that the ACBS (in a letter of 22nd October 2014) did not consider that it could address the application as it then stood. Nutricia then replied on 25^th November 2014 seeking to address the ACBS's concerns. However, no final decision has yet been taken. The allegation of breach under Article 34 TFEU has now transmogrified into an allegation that a delay in a decision under the Drug Tariff is unlawful and prohibited. This necessitates an understanding of how the evaluation of a product under the FSMP Directive or some other regime may be relevant for tariff purposes. The position evidentially is far from straightforward. For instance the actual role that formal classifications play under the Drug tariff is a complex issue. Final Decision List B of Part XV of the Drug Tariff is a cross-index listing clinical conditions and the products which have been approved by the ACBS for the management of those conditions. An applicant for listing must therefore indicate the clinical condition to which the product relates on the application form to be submitted to the ACBS. The clinical indication is not specified for the product in order to make a health claim but, rather, to enable the ACBS to know which section of List B of Part XV of the Drug Tariff within which to include the product. Once placed upon the tariff it then permits the clinician to identify which products might be suitable for the conditions they are examining.

One of the questions posed by the application form was as to the "proposed indication of use" to allow the ACBS to identify both the clinical usage of the product and to determine the relevant condition to which it should be attached on List B if approved. Without such an intended indication the Defendant submits that it cannot determine a proper suitability for reimbursement as in order to determine suitability it is necessary to know intended use. In the application form relating to Souvenaid as a food supplement Nutricia answered the proposed indications for use question with "for early Alzheimer's Disease"; and in the application for Souvenaid as an FSMP the proposed indication was "for the dietary management of early Alzheimer's disease".

Mr Roger Phillips, the Chief Commercial Officer for the Global Medical Division of Danone Trading BV, a company within the Claimant group, stated in his witness statement as follows:

"While the DOH may state that ACBS's "recommendation" and Souvenaid's appearance in the Drug Tariff is not a necessary precondition for dispensing on the NHS, in our experience in practice not appearing on the Drug Tariff presents a very considerable bar to commercial success and very few clinicians will choose to prescribe the product without such a listing".

Nutricia, in order to seek to overcome the complications caused by the dispute about Souvenaid as an FSMP, has approached the ACBS, in relation to Souvenaid as a supplement. The ACBS response stated:

"Whilst we acknowledge that there could potentially be alternative presentations of Souvenaid as a food supplement (or fortified food), the information you have provided demonstrates that you are seeking to market Souvenaid as "for early Alzheimer's disease". Under law, this particular claim could not be permitted for a food supplement. If Souvenaid is to be marketed as a food supplement it may include authorised nutrition and health claims, where the product complies with the conditions of use, and it is open to you to apply under the nutritional and health claims legislation for a specific disease risk reduction claim for Souvenaid".

Where does all of this lead to? A detailed understanding of the working of the Drug Tariff in my judgment is essential to analysing the application of Article 34 TFEU: this is evident from Case C-238/82 Duphar v Netherlands [1984] ECR 523 at paragraphs [20ff]. But no such proper or sufficient evidence or analysis exists. There is a lack of clarity about Nutricia's true intent in relation to the Drug Tariff.

I am quite clear that the original challenge must fail. I have also come to the conclusion that it would be quite wrong to allow the case to proceed in the fundamentally altered way that it has. The new case lacks proper shape and form. There are material gaps in the evidence. I am unconvinced that the attempt to squeeze Souvenaid through as a supplement is more than a tactic, which seems also to be the concern of the ACBS at present. At the end of the day this new aspect of the case is too imprecise and unformulated to succeed. Nutricia has failed to meet its standard of proof under Article 34 TFEU and for this reason I reject the new claim as it is presently formulated.

I put the point this way so that if at some future point in time the facts develop and a credible case can be advanced under the Drug Tariff properly supported with evidence and which, in accordance with the rules, is formally made the subject of a Claim Form then Nutricia is not precluded by this judgment from advancing the argument.

For these reasons the claim under Article 34 TFEU fails.

H. Questions for reference to the Court of Justice

(i) Questions to be referred

I have decided to make a reference to the Court of Justice of certain questions which I have set out in the Order which is scheduled to this Judgment. The questions arise out of my conclusions on Issue III above.

(ii) The reasons for reference

I set out below briefly the reasons which have led me to this conclusion.

First, it is necessary to obtain an answer to the questions being referred in order to determine the outcome of this judicial review. I have been able to decide a number of other questions either upon a definitive or provisional basis but, ultimately, whether this application for judicial review succeeds or fails will depend upon the answers given by the Court of Justice to the questions referred to it.

Secondly, the questions referred are important threshold issues. The definition of an "FSMP" in Article 1(2)(b) of the FSMP Directive is cast in broad and relatively unspecific terms. The parties in the present case are agreed that it has within it a number of different components. In particular, it is said that there are six components though the fifth component has two discrete parts to it. For the sake of convenience I repeat the definition in Article 1(2)(b) and number the different components therein:

"…a category of foods [1] for particular nutritional uses [2] specially processed or formulated and [3] intended for the dietary management of patients and to be used [4] under medical supervision. They are [5] intended for the exclusive or partial feeding of patients [5a] with a limited or disturbed capacity to take, digest, absorb metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites or [5b] with other medically-determined nutrient requirements, [6] whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional purposes, or by a combination of the two".

Words and phrases such as "particular", "intended for", "under medical supervision", "of patients", "medically-determined", "whose dietary management", "modification", "normal diet", are all terms with a multiplicity of meanings. The importance of precision in these component parts of the definition is highlighted by the fact that the FSMP Directive is one of a number of different legislative measures which, collectively, are intended to create a coherent overall regime for the governance of certain food products which have nutritional or medical consequences. The definition of an "FSMP" is thus a key determinant as to the regime which applies. It is a threshold term and its precise meaning is an issue of importance to both Competent Authorities and to producers and sellers who seek to know where one regime starts and another ends. This is especially important in a regime where there is a degree of self-certification and where a wrong classification decision could result in criminal law sanctions. The definitional questions referred are thus important issues to the regulatory regime as a whole.

Thirdly, there is evidence before the Court that different Member States are applying the rules in different ways, leading to different end-results. From the perspective of legal certainty and from the perspective of the integrity of the internal market it is desirable that there should be the greatest degree of consistency in the operation of these rules by the various Competent Authorities. I observe that the question of the disparity of treatment of various products has been a matter for considerable concern as is reflected in the recitals to Regulation 609/2013 set out at paragraphs [65] and [66] above.

(iii) The difference in overall approach: objective or subjective?

The questions set out in the Schedule focus upon a fundamental difference in approach between the parties. In particular, the Claimant submits that there is an element of clinical subjectivity inherent in the definition of an FSMP and within the scheme of regulation generally. It is submitted that the scheme involves self-certification in that manufacturers and sellers must decide for themselves whether they have to comply with the FSMP rules and this assumes that they will be responsible for classifying their products as an FSMP or otherwise. If the manufacturer or seller gets that decision wrong then it is at risk of sanctions imposed within national law. But there is no regime of formal prior authorisation and that necessarily means that manufacturers and sellers bear responsibility for classification. The Claimant submits that this does not lead to abuse because the classification exercise must be performed in the light of Article 3 of the FSMP Directive which emphasises the need for decisions to be taken upon the basis of sound medical and nutritional principles demonstrated by generally accepted scientific data. This introduces objectivity into the process and prevents partisan or biased decisions by the manufacturer or seller. The Claimant relies upon the fact that within Article 1(2)(b) there are references to the manufacturer's intention and that, pursuant to Article 3, it is the manufacturer or seller who (at least in the first instance) will be responsible for applying sound medical and nutritional principles to issues of formulation. As such it is submitted that properly interpreted the test for an FSMP is a combination of subjective and objective ingredients. It is said that it follows that it is not therefore open to the Competent Authorities to second guess the clinical assessments made by manufacturers.

The Defendant, for his part, submits that properly interpreted the FSMP Directive implies an objective test for what is or is not an FSMP. The Defendant submits that were the position to be otherwise (as Nutricia suggests) it would be to allow a regime which lacked legal certainty and opened up the possibility of abuse with manufacturers and sellers in effect deciding for themselves and for commercial reasons and without the possibility of Competent Authorities exercising proper objective control which regime they wished to fit into. The Defendant also submitted that even if the Claimant was correct and the system includes an element of subjective self-certification this still did not mean that if a Competent Authority disagrees with a manufacturer's classification it is precluded from forming its own definitive view on whether a product was an FSMP (subject to supervision by a Court) and from taking effective enforcement proceedings thereafter. In essence, the Competent Authority was not bound by the subjective view of the company concerned where that view might have been as much affected by commercial considerations as it was by wholly objective clinical, medical and nutritional conditions. The Defendant also submits that in an area involving public health and consumer protection only an objective approach involving "effective monitoring" should suffice.

There are thus two very different views of the approach to be adopted to the test for an FSMP. The "intake point" and the "modification point" questions reflect this dichotomy in approach.

(iv) Questions relating to the size of the relevant patient group

A further dispute which arises focuses upon the size or scale of the cohort of sufferers of a condition that must meet the test for an FSMP. The Claimant criticises the Defendant for holding the view that for a product to meet the definition of an FSMP it must be beneficial and efficacious in relation to the entirety of the medical category, in casu early onset AD sufferers. The Claimant submits that it is sufficient for a product to amount to an FSMP regardless of whether it meets the needs of all or a portion of the total cohort of relevant sufferers, provided it is considered by an individual clinician, to be safe, beneficial and efficacious in relation to a particular patient. Either way, a manufacturer or seller of a product need not establish that the product meets the FSMP criteria for the entirety of the relevant cohort. In fact counsel for the Defendant did not suggest, during the hearing, that a product had to be beneficial and efficacious for the entirety or "all" of a cohort of sufferers of a particular condition. It was accepted that something less than the total cohort would suffice. However the Defendant also did not accept that the test of benefit and efficacy was to be measured against the requirements of individual patients. The Defendant pointed out that if Nutricia was correct it would be entitled to market Souvenaid as an FSMP if only one doctor recommended or prescribed Souvenaid as beneficial and efficacious even though the majority of other doctors disagreed. The Question thus focuses upon the identification of the size or scale of the body of persons for whom a particular product must meet the test for an FSMP.

(v) The intake point

The questions also concern the benchmark of normality ("normal diet") set out in the proviso to the definition of an FSMP in Article 1(2)(b). The definition indicates that a product cannot be an FSMP where modification of a normal diet will achieve requisite dietary management of a patient. What role is played by the concept of a "normal" diet in Article 1(2)(b)? Is the benchmark of normality the condition of a hypothetical reasonable patient with a normal diet; or is it that of a particular, individual, patient whose normal diet is deficient? There may be more than one meaning which can be attributed to the concept of normality. The issue is, in one sense, quite specific to the facts of the present case which concerns early onset of AD a particular characteristic of which is the inadequate adherence of sufferers to a normal diet. However the issue is of a broader, more generic, significance also because the very concept of normality implies some normative benchmark. A food is beneficial or efficacious against some standard. The question is what that benchmark standard should be. What is par? The Court of Justice might conclude that, as the Claimant submits, it is a matter for individualised clinical judgment based upon the professional evaluation of a medical professional that whilst the patient does suffer from an inadequate diet (which inadequacy could be resolved by other means) nonetheless the patient would be best served by taking a product such as Souvenaid which was easy to consume and accessible and would hence be more likely to be taken regularly by the patient. Alternatively, the Court might conclude that the purpose of an FSMP is about marketing claims and it is a residual categorisation for products which create a real and tangible improvement in patients who could not obtain alleviation of their condition from any other source whether that be supplements, fortified foods or assistance with the taking of a normal diet.

(vi) The modification point

The questions also address the related modification point which arises in the caveat in Article 1(2)(b) of the FSMP Directive which precludes a product from amounting to an FSMP where modification of the patient's normal diet would suffice to provide the relevant nutrients. The questions focus upon two aspects of this definition. First, whether the product is disqualified from being an FSMP because the patient's dietary and nutritional needs may be met by supplements or other fortified foods. Secondly, whether the test is one of practicality and medical judgment in an individual case, or, whether it is concerned with whether modification of a (typical) AD patient's diet is theoretically possible to address a nutritional need? Or, is it some other test?

The Summary Report of the Standing Committee of the Commission (see paragraph [94] above) indicates that the view of the Commission is that food supplements (and presumably fortified foods) should be taken into account in determining whether modification of a patient's dietary requirements may suffice, and thereby lead to a product not being classified as an FSMP. The Claimant criticises this interpretation as involving a misconstruction of the FSMP Directive. The Claimant submits as follows:

"The [Defendant] contended that the "modification of the normal diet" limb requires a focus on the general or abstract use of foods, food supplements and fortified foods as a potential replacement for an FSMP. If such theoretical potential replacement is possible on the abstract level (even if not feasible for certain patients or in certain circumstances) then according to the [Defendant] the product cannot be an FSMP.

This is fundamentally to misread the last limb of the definition, which is necessarily focused upon the particular patient with particular needs under medical supervision. It ignores the fact that the choice of an FSMP is a medically led/supervised step and in many cases will involve a choice of a FSMP over an alternative approach to diet on a patient specific basis. As [the Claimant's evidence] demonstrates it will be very rare that a FSMP is the only way to provide certain nutritional requirements to patients (the point being most obvious with tube and sip feeds which can easily be replicated from ordinary foodstuffs or food supplements).

From a clinical perspective, for some patients suffering, say, from disease related malnutrition it may be appropriate to prescribe a FSMP; for others it may be appropriate instead simply to give them a diet plan or diet advice. It is the role of the "medical supervision", which limb 3 requires, to decide upon the appropriate dietary management for any particular patient. It is only such medical supervision that can decide whether a particular form of dietary modification not using FSMPs is realistic for that patient, or whether in fact the required "dietary modification" is one that "cannot be achieved". To attempt to answer such questions axiomatically and by reference to the treatable cohort as a whole (e.g. to ask the question for all sufferers of all forms of malnutrition, so as to decide whether a sip feed is a FSMP) is nonsensical. Rather FSMPs must meet medically identified nutritional needs for particular patients, for which patients the supervising clinician has also decided that the FSMP is the required means to achieve the desired dietary management".

The Defendant rejects this construction because it attributes a pivotal role to the manufacturer's subjective evaluation. The Defendant submits that the test must be wholly or predominantly objective and that the FSMP Directive must be read in this light. The Defendant points out that the relevant part of the definition reads: "patients…whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two". The term "modification of the normal diet" means changing the normal diet and can include adding more of an element of the normal diet. Food supplements are, by definition, "foodstuffs the purpose of which is to supplement the normal diet…" (cf. Article 2(a) of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements). Accordingly, "modification" of a normal diet within the definition of an FSMP necessarily includes supplementation by food supplements or fortified foods. Further, the definition expressly excludes cases where the relevant condition may be addressed by foods for particular nutritional uses (PARNUTS) and that it would be arbitrary for a different approach to be taken to conditions which may be addressed via food supplementation. The Defendant endorses the view expressed by the Commission in this regard.

The Defendant points out that the wording used in the FSMP Directive - "cannot be achieved" - implies a stricter test. The Defendant submits that to subject the applicability of the FSMP designation to the subjective clinical judgment of individual professionals would render the scheme, as a whole, inconsistent and impossible to supervise.

I. Conclusions

For the reasons set out in this judgment I decide Issues I, II and IV in favour of the Defendant.

The questions of law arising out of Issue III and set out in the Order scheduled hereto are to be referred to the Court of Justice.

THE ORDER FOR REFERENCE

IN THE HIGH COURT OF JUSTICE

QUEEN'S BENCH DIVISION

ADMINISTRATIVE COURT

MR JUSTICE GREEN

B E T W E E N:

THE QUEEN

on the application of

Nutricia Limited (Claimant)

- and -

Secretary of State for Health (Defendant)

ORDER FOR REFERENCE PURSUANT TO ARTICLE 267 OF THE TREATY ON THE FUNCTIONING OF THE EUROPEAN UNION

UPON the Claimant's claim for judicial review dated 20 December 2013

AND UPON hearing Leading and Junior Counsel for the Claimant and Leading Counsel for the Defendant.

AND UPON the Court in the judgment (the Judgment), to which this Order forms a part, deciding that in order to enable it to give final judgment in this case it is necessary to resolve questions concerning the interpretation of European Union law and that it is appropriate to request the Court of Justice of the European Union to give a preliminary ruling thereon.

IT IS ORDERED THAT:

Pursuant to CPR 68.2 the questions set out in the Schedule hereto, concerning the jurisdiction of the Court of Justice and the interpretation of Commission Directive 1999/21/EC be referred to the Court of Justice for a preliminary ruling in accordance with Article 267 of the Treaty on the Functioning of the European Union ("TFEU").

The proceedings be stayed until the Court of Justice has given a preliminary ruling on the questions referred or until further order.

Costs are reserved.

There be liberty to apply.

SCHEDULE TO THE ORDER

Note: The High Court has prepared the reference with a view to it being self-contained. The High Court would suggest to the Court that there is therefore no need for the Court to translate the actual Judgment of which this Schedule forms a part. It is intended that all of the information that the Court of Justice needs in order to understand and determine the reference and place it in its proper context has been set out in this Schedule. In this way it is intended to reduce the burden of translation upon the Court.

QUESTIONS REFERRED

Questions referred to the Court of Justice

In order for a product to be a dietary food for special medical purposes ("FSMP") within the definition set out in Article 1(2)(b) of Commission Directive 1999/21/EC on dietary foods for special medical purposes:

a. Must it be the case, objectively, that:

(i) all patients suffering from the particular disease, disorder or other medical condition for the dietary management of which the product is marketed ("the Indicated Condition") or

(ii) a sub-group of such patients

have a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or other medically-determined nutrient requirements that arise as a result of the Indicated Condition? Or

b. Alternatively, is it also sufficient if the manufacturer intends that the product's use should be "medically determined" for the purpose of Article 1(2)(b) in the sense that: (i) the manufacturer intends the product to be used only under medical supervision by clinicians treating patients with the Indicated Condition, and (ii) a responsible supervising clinician could properly form a clinical judgment, on a patient by patient basis, that the use of such product would be an appropriate form of dietary management for some patients suffering from the Indicated Condition because the clinician reasonably considers such a patient to have particular nutritional requirements related to the Indicated Condition?

c. If the answer to question 1(a)(ii) is "yes", then (i) what proportion of patients with the Indicated Condition must have the relevant limited, impaired or disturbed capacity or other medically-determined nutrient requirements, or is there no minimum proportion, and (ii) is it necessary for that sub-group of patients to be identifiable in advance at the time when the product is marketed?

d. If the answer to question 1(b) is "yes", then what are the "particular nutritional requirements" which the use of the product must be safe, beneficial and effective in meeting for the purposes of Article 3?

As regards the phrase "whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two" in Article 1(2)(b), how should the potential for modification of the diet be assessed? In particular:

a. Are considerations of safety and practicability of diet modification relevant in this assessment? If so, how are they to be taken into account?

b. Is such potential for modification of the normal diet (and if relevant, are considerations of safety and practicability) to be assessed:

(i) Generically, and in advance, by reference to: (i) a typical person with a typical diet with the typical abilities of such a person to modify their diet; or (ii) a typical sufferer of the Indicated Condition, with the diet typical of such a sufferer, and the ability to modify diet typical to such a sufferer; or (iii) some other assumed set of patient characteristics?

(ii) Individually and in the course of patient treatment, using the clinical judgment of the supervising clinician, such that it is enough if a manufacturer reasonably intends the product to be clinically useful because a supervising clinician may come to decide on reasonable patient-specific grounds (for instance, on patient-specific safety or practicability grounds) that the use of a FSMP may be clinically preferable to other forms of diet modification for some patients with the Indicated Condition? Or

(iii) Otherwise, and if so how?

c. Does "modification of the normal diet" include the use of 'food supplements' within the meaning of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements, or of 'fortified foods' falling within Regulation 1925/2006/EC on the addition of vitamins and minerals and of certain other substances to foods?

d. Where a patient group suffering from a particular disease, disorder or other medical condition has difficulty remembering to eat a normal diet unless prompted, is a product designed to facilitate the consumption by such patients of nutrients which would form part of the normal diet capable of being a dietary food for medical purposes within Commission Directive 1999/21/EC on dietary foods for special medical purposes?

BACKGROUND TO THE QUESTIONS REFERRED

The questions arise from the Defendant's expression of its view that a yoghurt style food product called "Souvenaid" produced by Nutricia Limited ("Nutricia") could and should not be classified as a food for special medical purposes or "FSMP".

The relevant legislation

Products that are intended to provide some form of nutritional supplementation to the human diet are broadly categorised, as being either: fortified foods;^[1] food supplements;^[2] Foods for Particular Nutritional Uses ("PARNUTs");^[3] or FSMPs. Each category is subject to a distinct regulatory framework.

(i) Fortified foods

"Fortified foods" are governed by Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods ("the Fortified Foods Regulation"). These define certain circumstances in which vitamins and minerals may be added to foods intended, under normal circumstances, to provide all necessary nutrients for "normal development and maintenance of a healthy life" (Recital 7). These include situations where there are demonstrable nutritional deficiencies attributable to the "socio-economic situation prevailing in the Community and the life styles of different groups of the population" (Recital 8). The Fortified Foods Regulation is aimed at healthy eaters and applies without prejudice to specific provisions provided in other EU legislation concerning:

"… foods for particular nutritional uses and, in the absence of specific provisions, compositional requirements of such products rendered necessary by the particular nutritional requirements of the persons for whom they are intended".

(Article 1(3)(a))

Typical fortified foods include breakfast cereals with added vitamins and minerals.

(ii) Food supplements

These are governed by the terms of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 ("the Food Supplements Directive"). These govern those foodstuffs supplementing the normal diet, to provide all necessary nutrients for "normal development and maintenance of a healthy life" (Recital 3). The Food Supplements Directive, like the Fortified Foods Regulation, is also aimed at healthy eaters and accordingly the definition of a "food supplement" in Article 2(a) of the Food Supplements Directive reads as follows:

"…foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities".

One aspect of the dispute between the parties in this case concerns the view of the Defendant that Souvenaid may be either (a) a food supplement and/or (b) a fortified food and should therefore be marketed as such; but is not (c) an FSMP.

(i) The PARNUTS Directive

"PARNUTS" are foodstuffs which are "clearly distinguishable from foodstuffs for normal consumption". These are suitable for certain specified nutritional purposes "owing to their special composition or manufacturing process".

PARNUTS were originally regulated pursuant to Council Directive 89/398/EEC of 3^rd May 1989 ("the Old PARNUTS Directive"). This directive has now been replaced by the PARNUTS Directive; but it still significant because it was pursuant to Article 4(1) thereof that the FSMP Directive (set out below) was adopted in March 1999. Article 4(1) provided that for the products listed in Annex 1 to the directive (which included "dietary foods for special medical purposes") "specific" directives should be adopted (by the Commission in accordance with the procedure laid down in Article 13) which could address in particular:

"(a) essential requirements as to the nature or composition of the products;

(b) provisions regarding the quality of raw materials;

(c) hygiene requirements;

(d) permitted changes within the meaning of Article 3 (2);

(e) a list of additives;

(f) provisions regarding labelling, presentation and advertising;

(g) sampling procedures and methods of analysis necessary for checking compliance with the requirements of the specific Directives".

Article 1(2)(a) of the Old PARNUTS Directive defined foodstuffs for particular nutritional uses as:

"…foodstuffs which, owing to their special composition or manufacturing process, are clearly distinguishable from foodstuffs for normal consumption, which are suitable for their claimed nutritional purposes and which are marketed in such a way as to indicate such suitability".

The Old PARNUTS Directive went on to state in Article 1(2)(b) that a "particular nutritional use" shall "fulfil the particular nutritional requirements":

"(a) of certain categories of persons whose digestive processes or metabolism are disturbed; or

(b) of certain categories of persons who are in a special physiological condition and who are therefore able to obtain special benefit from controlled consumption of certain substances in foodstuffs; or

(c) of infants or young children in good health".

The recitals to this directive explained that one of the purposes of the monitoring obligation which is imposed upon the competent authorities of the Member States is "to check whether a foodstuff actually has the particular nutritional properties attributed to it" (Recital 6).

Directive 89/398/EEC was replaced by the PARNUTS Directive. Its Article 1(2) and Article 1(3) correspond entirely to what was previously Article 1(2)(a) and (b) of the Old PARNUTS Directive.

(ii) The FSMP Directive

Foods for special medical purposes are regulated separately under Commission Directive 1999/21/EC upon dietary foods for special medical purposes ("the FSMP Directive"). The FSMP Directive was adopted pursuant to an exercise of express legislative powers under the Old PARNUTS Directive. It is common ground therefore that FSMPs are a subset of PARNUTS but they are nonetheless subject to their own particular regulatory regime. The FSMP Directive thus regulates the subset of PARNUTS referred to in recital 1 to the FSMP Directive viz: "dietary foods for special medical purposes… intended to meet the particular nutritional requirements of persons affected by or malnourished because of a specific disease, disorder or medical condition; whereas for this reason they must be used under medical supervision…".

Recitals 1-10 of the FSMP Directive set out its purpose and, as such, they are relevant to the interpretation of the substantive provisions of the directive:

"(1) Whereas dietary foods for special medical purposes are intended to meet the particular nutritional requirements of persons affected by or malnourished because of a specific disease, disorder or medical condition; whereas for this reason they must be used under medical supervision which may be applied with the assistance of other competent health professionals;

(2) Whereas such foods are numerous and their composition may differ substantially depending on the specific disease, disorder or medical condition of the patients for whom they are intended, the age of the patients and the place in which they receive health care support, on whether the foods are intended to be used as the sole source of nourishment or not, and possibly on other factors;

(3) Whereas, because of the wide diversity of such foods and the rapidly evolving scientific knowledge on which they are based, it is not appropriate to lay down detailed compositional rules;

(4) Whereas, however, some basic rules concerning vitamin and mineral substances content can be laid down for products considered to be nutritionally complete for covering the particular nutritional requirements of the intended user; whereas such rules for nutritionally incomplete foods can be laid down only for the maximum levels of these substances as appropriate;

(5) Whereas this Directive reflects current knowledge about those products; whereas any modification to allow for innovation based on scientific and technical progress will be decided in accordance with the procedure laid down in Article 13 of Directive 89/398/EEC;

(6) Whereas pursuant to Article 4(2) of Directive 89/398/EEC, the provisions relating to the substances with specific nutritional purposes to be used in the manufacture of foods for special medical purposes should be laid down in a separate Commission directive;

(7) Whereas pursuant to Article 7 of Directive 89/398/EEC, the products covered by that Directive are subject to the general rules laid down by Council Directive 79/112/EEC of 18 December 1978 on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs (3), as last amended by Commission Directive 1999/10/EC (4); whereas the present Directive adopts and expands upon the additions and exceptions to those general rules, where appropriate;

(8) Whereas, in particular, in view of the nature and destination of dietary foods for special medical purposes, it is necessary to provide information concerning the energy value and principal nutrients contained in such foods;

(9) Whereas, given the particular nature of dietary foods for special medical purposes, additional means to those usually available to monitoring bodies should be available in order to facilitate efficient monitoring of those products;

(10) Whereas, in accordance with the principle of proportionality, it is necessary and appropriate for the achievement of the basic objective of approximating the laws of the Member States relating to foodstuffs intended for particular nutritional uses to lay down rules on foods for special medical purposes; whereas this Directive confines itself to what is necessary in order to achieve the objectives pursued in accordance with the third paragraph of Article 3b of the Treaty.

The definition of an FSMP is set out in Article 1(2)(b) of the FSMP Directive, as follows:

"dietary foods for special medical purposes' means a category of foods for particular nutritional uses specially processed or formulated and intended for the dietary management of patients and to be used under medical supervision. They are intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two".

Article 2 of the FSMP Directive imposes an express duty on Member States to enforce the rules. The Article provides as follows:

"Member States shall ensure that dietary foods for special medical purposes may be marketed within the Community only if they comply with the rules laid down in this Directive".

The suitability of FSMP for their dietary purpose is covered by Article 3 of the FSMP Directive which prays in aid both nutritional and medical principles and the notion of "generally accepted scientific data":

"The formulation of dietary foods for special medical purposes shall be based on sound medical and nutritional principles. Their use, in accordance with the manufacturer's instructions, shall be safe and beneficial and effective in meeting the particular nutritional requirements of the persons for whom they are intended, as demonstrated by generally accepted scientific data. They must comply with the compositional criteria specified in the Annex".

Article 4 lays down rules governing such matters as: (i) the collective name for FSMP products; (ii) labelling requirements and the duty to specify energy values, average quantities of mineral components, protein, carbohydrate, fat and other nutrients contents, information on osmolality or osmolarity; (iii) information on the origin and the nature of the protein and/or protein hydrolysates: (iv) relevant medical notices and hazard warnings; (v) instructions for use.

Article 5 of the FSMP Directive makes it clear that Member States, as part of their Article 2 duty to ensure compliance, must provide for a notification procedure to facilitate "efficient monitoring" of FSMPs.

The facts

(i) The product, Souvenaid

Souvenaid is a 1kcal/ml, vanilla or strawberry flavoured, milk-based drink containing Omega 3 fatty acids, Uridine, Choline and a range of vitamins and minerals. Nutricia has formulated Souvenaid to address what it considers to be the special nutrient requirements for those diagnosed with early AD. The manufacturer's recommended daily intake equates to a single 125ml bottle per day.

Souvenaid is the product of combined research into the effects of nutrition upon AD between the Claimant and the Massachusetts Institute of Technology ("MIT") that dates back to 2005, together with the benefit of funding from the Government of the Netherlands and from the European Union. Research into the product has included 3 clinical trials involving more than 1,000 AD patients.

The product is designed for a single purpose, namely the dietary management of patients with early AD. It is the Claimant's intention that it is only to be used under medical supervision. It is marketed to healthcare practitioners ("HCPs"), which therefore limits its use and as such, it is not marketed in the UK through general retail or 'over the counter' channels. Instead, availability is limited to that under the control of a healthcare professional, such as prescription or "HCP recommendation" where the patient pays for Souvenaid themselves, though the Secretary of State has pointed out that Nutricia sells Souvenaid from its website.

Nutricia's stated rationale behind the formulation of Souvenaid is to seek to counteract the effects of synapse loss amongst those with early AD by a specific combination of nutrients that are designed to encourage synapse formation. The symptoms of AD are associated with a progressive and escalating loss of synapses, which are connections between specialist nerve cells (neurones) in the brain.

Nutricia submitted to the court that the human body's generation of synapses is primarily via a metabolic pathway known as the Kennedy Pathway, which is in turn dependent upon nutrients obtained from the individual's diet. In particular, the Kennedy Pathway is reliant upon uridine (which the body itself synthesises in healthy adults), Omega 3 fatty acids (EPA and DHA) and choline ("the Key Nutrients"). Early AD sufferers must (by contrast with healthy adults) make increased amounts of neurones to replace those lost to the disease. Nutricia submits that the rationale of Souvenaid is to provide the Key Nutrients that will support such demand for increased synapse formation.

The position adopted by Nutricia was clinical trials confirmed that Souvenaid is a product that is safe, well tolerated, with no significant side effects and is able to be conveniently used by this particular cohort of AD patients (there was a 97% compliance rate demonstrated, i.e. 97% of the patients adhered to the diet containing Souvenaid). The clinical trials undertaken also showed improvements in the memory of patients with early AD over 12 weeks and 24 weeks in respective trials, with electroencephalography ("EEG") results providing evidence of preserved and even potentially increased synapse formation though. The Defendant had not at the stage of this reference, formed a concluded position on these matters.

The product is manufactured in the Netherlands and is currently marketed and exported for sale in 12 EU Member States other than the UK, namely Austria, Belgium, Finland, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Poland, Spain and Sweden. It has been notified to the Competent Authorities as an FSMP in accordance with the FSMP Directive, where required, in those 12 Member States.

(ii) The Dispute

There is a complex factual context to the dispute, that is more fully set out in the Judgment reported as R(Nutricia) v Secretary of State for Health [2015] EWHC 2285 (Admin). For present purposes it suffices to state that in August 2014, after receipt of evidence and submissions from Nutricia, the Defendant decided, as the domestic court has decided it was entitled, that Souvenaid was not a FSMP on two principal grounds. First, that Nutricia had not established in its evidence that Souvenaid met a "special nutritional" requirement ("the Intake Point"). Secondly, that Nutricia had failed to establish that even if Souvenaid met a "special nutritional" requirement, a patient's needs could not be met by modification of the patient's diet for instance by the introduction of food supplements ("the Modification Point").

Nutricia brought judicial review proceedings against this decision, challenging, amongst other things, the Defendant's interpretation of the FSMP definition ("the Judicial Review").

(iii) The arguments of the parties

The Court has decided that it is necessary to obtain an answer to the questions being referred in order to determine the outcome of the Judicial Review, having decided a number of other questions either upon a definitive or provisional basis. However, final disposal of all the issues arising in the Judicial Review turns upon the answers to the questions.

The questions referred raise important threshold issues. The definition of an "FSMP" in Article 1(2)(b) of the FSMP Directive is cast in broad and relatively unspecific terms. The parties in the present case are agreed that it has within it a number of different components. In particular, it is said that there are six components though the fifth component has two discrete parts to it, as follows:

"…a category of foods [1] for particular nutritional uses [2] specially processed or formulated and [3] intended for the dietary management of patients and to be used [4] under medical supervision. They are [5] intended for the exclusive or partial feeding of patients [5a] with a limited or disturbed capacity to take, digest, absorb metabolise or excrete ordinary foodstuffs or certain nutrients contained therein or metabolites or [5b] with other medically-determined nutrient requirements, [6] whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional purposes, or by a combination of the two".

Words and phrases such as "particular", "intended for", "under medical supervision", "of patients", "medically-determined", "whose dietary management", "modification", "normal diet", are all terms with a multiplicity of meanings. The importance of precision in these component parts of the definition is highlighted by the fact that the FSMP Directive is one of a number of different legislative measures which, collectively, are intended to create a coherent overall regime for the governance of certain food products which have nutritional or medical consequences. The definition of an "FSMP" is thus a key determinant as to the regime which applies. It is a threshold term and its precise meaning is an issue of importance to both Competent Authorities and to producers and sellers who seek to know where one regime starts and another ends. This is especially important in a regime where there is a degree of self-certification and where a wrong classification decision could result in criminal law sanctions. The definitional questions referred are thus important issues to the regulatory regime as a whole.

Different Member States are applying the rules in different ways, leading to different end-results. From the perspective of legal certainty and from the perspective of the integrity of the internal market it is desirable that there should be the greatest degree of consistency in the operation of these rules by the various Competent Authorities. The question of the disparity of treatment of various products has been a matter for considerable concern as is reflected in recitals 9 and 10 to Regulation 609/2013, replacing the PARNUTS and FSMP regime, which entered into force in July 2013 but which shall only be applicable from 20^th July 2016 (with certain limited exceptions which are not relevant to the present case).

The questions referred upon a fundamental difference in approach between the parties. In particular, the Claimant submits that there is an element of clinical subjectivity inherent in the definition of an FSMP and within the scheme of regulation generally. It is submitted that the scheme involves self-certification in that manufacturers and sellers must decide for themselves whether they have to comply with the FSMP rules and this assumes that they will be responsible for classifying their product as an FSMP or otherwise. If the manufacturer or seller gets that decision wrong then it is at risk of sanctions imposed within national law. But there is no regime of formal prior authorisation and that necessarily means that manufacturers and sellers bear responsibility for classification.

The Claimant submits that this does not lead to abuse because the classification exercise must be performed in the light of Article 3 of the FSMP Directive which emphasises the need for decisions to be taken upon the basis of sound medical and nutritional principles demonstrated by generally accepted scientific data. This introduces objectivity into the process and prevents partisan or biased decisions by the manufacturer or seller. The Claimant relies upon the fact that within Article 1(2)(b) there are references to the manufacturer's intention and that, pursuant to Article 3, it is the manufacturer or seller who (at least in the first instance) will be responsible for applying sound medical and nutritional principles to issues of formulation. As such it is submitted that properly interpreted the test for an FSMP is a combination of subjective and objective ingredients. It is said that it follows that it is not therefore open to the Competent Authorities to second guess the clinical assessments made by manufacturers, if those assessments are reasonable and accord with body of responsible medical opinion. It is enough that the manufacturer makes a product for which there is or they anticipate there will be a proper clinical demand; in other words some (if not all) responsible and competent clinicians can properly decide that for a particular patient with the relevant condition it is in their best clinical interests to have their condition dietetically managed using the product because of the nutrients it contains.

The Defendant, for his part, submits that properly interpreted the FSMP Directive implies an objective test for what is or is not an FSMP. The Defendant submits that were the position to be otherwise (as Nutricia suggests) it would be to allow a regime which lacked legal certainty and opened up the possibility of abuse with manufacturers and sellers in effect deciding for themselves and for commercial reasons, and without the possibility of Competent Authorities exercising proper objective control, which regime they wished to fit into. The Defendant also submitted that even if the Claimant was correct and the system includes an element of subjective self-certification this still did not mean that if a Competent Authority disagrees with a manufacturer's classification it is precluded from forming its own definitive view on whether a product was an FSMP (subject to supervision by a Court) and from taking effective enforcement proceedings thereafter. In essence, the Competent Authority was not bound by the subjective view of the company concerned where that view might have been as much affected by commercial considerations as it was by wholly objective clinical, medical and nutritional conditions. The Defendant also submits that in an area involving public health and consumer protection only an objective approach involving "effective monitoring" should suffice.

There are thus two very different views of the approach to be adopted to the test for an FSMP. The "intake point" and the "modification point" questions reflect this dichotomy in approach.

A further dispute which arises focuses upon the size or scale of the cohort of sufferers of a condition that must meet the test for an FSMP.

37.1. The Claimant criticises the Defendant for holding the view that for a product to meet the definition of an FSMP it must be beneficial and efficacious in relation to the entirety of the medical category, in casu early onset AD sufferers

37.2. The Claimant submits that it is sufficient for a product to amount to an FSMP regardless of whether it meets the particular nutritional needs of all or a portion of the total cohort of relevant sufferers, provided it is considered, by an individual clinician, to be a safe, beneficial and efficacious form of dietary management in relation to a particular patient. Either way, a manufacturer or seller of a product need not establish that the product meets particular nutritional needs that will arise, as a result of the relevant condition, for the entirety of the relevant cohort of patients suffering from it.

37.3. In fact counsel for the Defendant did not suggest, during the hearing, that a product had to be beneficial and efficacious for the entirety or "all" of a cohort of sufferers of a particular condition. It was accepted that something less than the total cohort would suffice. However the Defendant also did not accept that the test of benefit and efficacy was to be measured against the requirements of individual patients.

37.4. The Defendant pointed out that if Nutricia was correct it would be entitled to market Souvenaid as an FSMP if only one doctor recommended or prescribed Souvenaid as beneficial and efficacious even though the majority of other doctors disagreed.

37.5. The Claimant by contrast pointed out that medical opinion frequently differed; what mattered was that the prescribing or supervising doctor was acting responsibly and competently, that is acting in a way supported by a responsible body of similar professionals. If the product could be used in this way, so as to meet the nutritional needs identified by such doctors, then the Claimant contended the product met a proper clinical need and so complied with Articles 1.2 and 3 of the FSMP Directive.

37.6. The Question thus focuses upon the identification of the size or scale of the body of persons for whom a particular product must meet the test for an FSMP.

The questions also concern the benchmark of normality ("normal diet") set out in the proviso to the definition of an FSMP in Article 1(2)(b). The definition indicates that a product cannot be an FSMP where modification of a normal diet will achieve requisite dietary management of a patient. What role is played by the concept of a "normal" diet in Article 1(2)(b)? Is the benchmark of normality the condition of a hypothetical reasonable patient with a normal diet; or is it that of a particular, individual, patient whose normal diet is deficient? There may be more than one meaning which can be attributed to the concept of normality. The issue is, in one sense, quite specific to the facts of the present case which concerns early onset of AD a particular characteristic of which is the inadequate adherence of sufferers to a normal diet. However the issue is of a broader, more generic, significance also because the very concept of normality implies some normative benchmark. A food is beneficial or efficacious against some standard. The question is what that benchmark standard should be. What is par?

38.1. The Court of Justice might conclude that, as the Claimant submits, it is a matter for individualised clinical judgment based upon the professional evaluation of a medical professional that whilst the patient does suffer from an inadequate diet (which inadequacy could be resolved by other means) nonetheless the patient would be best served by taking a product such as Souvenaid which was easy to consume and accessible and would hence be more likely to be taken regularly by the patient.

38.2. Alternatively, the Court might conclude that the purpose of an FSMP is about marketing claims and it is a residual categorisation for products which create a real and tangible improvement in patients who could not obtain alleviation of their condition from any other source or combination thereof whether that be supplements, fortified foods or assistance with the taking of a normal diet.

The questions also address the related modification point which arises in the caveat in Article 1(2)(b) of the FSMP Directive which precludes a product from amounting to an FSMP where modification of the patient's normal diet would suffice to provide the relevant nutrients. The questions focus upon two aspects of this definition. First, whether the product is disqualified from being an FSMP because the patient's dietary and nutritional needs may be met by diet modification, including the combination of foods, food supplements or other fortified foods. Secondly, whether the test is one of practicality and medical judgment in an individual case, or, whether it is concerned with whether modification of a (typical) AD patient's diet is theoretically possible to address a nutritional need. Or, is it some other test?

The Summary Report of the Standing Committee on the Food Chain and Animal Health of the meeting of 10th February 2014 indicates that the view of the Commission is that food supplements (and presumably fortified foods) should be taken into account in determining whether modification of a patient's dietary requirements may suffice, and thereby lead to a product not being classified as an FSMP. The Summary Report states as follows:

"The Commission recalled the definition of FSMPs given in Article 1(2)(b) of Directive 1999/21/EC and drew the attention of Member States on the consequences that a broad interpretation of this definition could entail. In this context, it called on Member States to take into account all the elements of the definition, including the one whereby FSMPs are intended for "(…) medically-determined nutrient requirements, whose dietary management cannot be achieved only by modification of the normal diet (…)". The Commission underlined that food supplements are regulated as foods and modification of the normal diet can include use of food supplements. It suggested that Member States pay particular attention to whether products notified as FSMPs would not in fact be food supplements".

The Claimant criticises this interpretation as involving a misconstruction of the FSMP Directive. The Claimant submits as follows:

"The [Defendant] contended that the "modification of the normal diet" limb requires a focus on the general or abstract use of foods, food supplements and fortified foods as a potential replacement for an FSMP. If such theoretical potential replacement is possible on the abstract level (even if not feasible for certain patients or in certain circumstances) then according to the [Defendant] the product cannot be an FSMP.

This is fundamentally to misread the last limb of the definition, which is necessarily focused upon the particular patient with particular needs under medical supervision. It ignores the fact that the choice of an FSMP is a medically led/supervised step and in many cases will involve a choice of a FSMP over an alternative approach to diet on a patient specific basis. As [the Claimant's evidence] demonstrates it will be very rare that a FSMP is the only way to provide certain nutritional requirements to patients (the point being most obvious with tube and sip feeds which can easily be replicated from ordinary foodstuffs or food supplements).

From a clinical perspective, for some patients suffering, say, from disease related malnutrition it may be appropriate to prescribe a FSMP; for others it may be appropriate instead simply to give them a diet plan or diet advice. It is the role of the "medical supervision", which limb 3 requires, to decide upon the appropriate dietary management for any particular patient. It is only such medical supervision that can decide whether a particular form of dietary modification not using FSMPs is realistic for that patient, or whether in fact the required "dietary modification" is one that "cannot be achieved". To attempt to answer such questions axiomatically and by reference to the treatable cohort as a whole (e.g. to ask the question for all sufferers of all forms of malnutrition, so as to decide whether a sip feed is a FSMP) is nonsensical. Rather FSMPs must meet medically identified nutritional needs for particular patients, for which patients the supervising clinician has also decided that the FSMP is the required means to achieve the desired dietary management".

The Defendant rejects this construction because it attributes a pivotal role to the manufacturer's subjective evaluation. The Defendant submits that the test must be wholly or predominantly objective and that the FSMP Directive must be read in this light. The Defendant points out that the relevant part of the definition reads: "patients…whose dietary management cannot be achieved only by modification of the normal diet, by other foods for particular nutritional uses, or by a combination of the two". The term "modification of the normal diet" means changing the normal diet and can include adding more of an element of the normal diet. Food supplements are, by definition, "foodstuffs the purpose of which is to supplement the normal diet…" (cf. Article 2(a) of Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements). Accordingly, "modification" of a normal diet within the definition of an FSMP necessarily includes supplementation by food supplements or fortified foods. Further, the definition expressly excludes cases where the relevant condition may be addressed by foods for particular nutritional uses (PARNUTS) and it would be arbitrary for a different approach to be taken to conditions which may be addressed via food supplementation. The Defendant endorses the view expressed by the Commission in this regard.

The Defendant points out that the wording used in the FSMP Directive - "cannot be achieved" - implies a stricter test. The Defendant submits that to subject the applicability of the FSMP designation to the subjective clinical judgment of individual professionals would render the scheme, as a whole, inconsistent and impossible to supervise.

Note 1    As governed by Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to food    [Back]

Note 2    As governed by the terms of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002    [Back]

Note 3    As governed by Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses (“the PARNUTs Directive”)    [Back]

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	England and Wales High Court (Administrative Court) Decisions
You are here: BAILII >> Databases >> England and Wales High Court (Administrative Court) Decisions >> Nutricia Ltd, R (on the application of) v The Secretary of State for Health [2015] EWHC 2285 (Admin) (31 July 2015) URL: http://www.bailii.org/ew/cases/EWHC/Admin/2015/2285.html Cite as: [2015] EWHC 2285 (Admin)

A.	Introduction, issues and conclusion	1-21
	(i) Introduction	1-12
	(ii) Issues	13-18
	(iii) Conclusions	19-21

B.	Legislative Framework	22-69
	(i) The four categories of product	22
	(ii) Fortified foods	23-24
	(iii) Food supplements	25-27
	(iv) PARNUTS	28-38
	(v) Foods for Special Medical Purposes	39-69
	(a) The FSMP Directive	39-47
	(b) Guidance provided by the Defendant on FSMPs	48-52
	(c) The Medical Food (England) Regulations 2000 – "MFER"	53-64
	(d) The new regime – Regulation (EU) 609/2013: 12th June 2013	65-69

C.	Relevant facts	70-101
	(i) Souvenaid	71-72
	(ii) The notification of Souvenaid to the Defendant	73
	(iii) The Defendant's concerns as to whether Souvenaid was an FSMP	74-76
	(iv) The Advisory Committee on Borderline Substances ("ACBS")	77-86
	(v) The discussions at EU level	87
	(vi) The First Decision: 23rd September 2013	88-92
	(vii) The EU Standing Committee meeting: 10th February 2014	93-96
	(viii) The instruction of Dr Dangour	97-99
	(ix) The Final Decision	100-101

D.	Issue I: Did the Department of Health have the power to take the Final Decision?	102-138
	(i) The issue	102-105
	(ii) Analysis of Final Decision	106-111
	(iii) Conclusions	112
	(a) The Final Decision was intra vires	112-113
	(b) The Marleasing approach to interpretation	114-119
	(c) The limits of the Marleasing approach	120
	(d) The mechanics of implementation: The choice of "form and method"	121-125
	(e) The application of the Marleasing principle to the MFER	126-138

E.	Issue II: Did the experts relied upon by the Department of Health have the relevant competence and expertise?	139-154
	(i) The issue as articulated by the Claimant	139-140
	(ii) The facts relevant to the issue	141-145
	(iii) The extent to which the issue is properly justiciable/conclusions	146-154

F.	Issue III: Did the Department of Health act perversely or irrationally in rejecting the evidence of the Claimant?	155-179
	(i) The provisional nature of the issue	155
	(ii) The scope and nature of the review process	156-164
	(iii) The intake point	165-175
	(iv) The modification point	176-179

G.	Issue IV: Does the Final Decision amount to a breach of Article 34 TFEU?	180-208
	(i) Articles 34 and 36 TFEU	180-185
	(ii) Claimant's submissions	186-193
	(iii) Analysis: Nutricia's formal case	194-197
	(iv) The new case: Alleged delay in processing Drug Tariff decisions	198-208

H.	Questions for reference to the Court of Justice	209-223
	(i) Questions to be referred	209
	(ii) The reasons for reference	210-214
	(iii) The difference in overall approach: objective or subjective?	215-217
	(iv) Questions relating to the size of the relevant patient group	218
	(v) The intake point	219
	(vi) The modification point	220-223

I.	Conclusion	224-225