England and Wales High Court (Administrative Court) Decisions

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

		Royal Courts of Justice Strand, London, WC2A 2LL
		22 May 2014

Mr Justice Supperstone :

Introduction

1. The Claimants produce and supply Dolenio, a glucosamine-containing product ("GCP") used in the treatment of osteoarthritis ("OA").
2. The Medicines and Healthcare Products Regulatory Agency ("MHRA") is an agency of the Department of Health. It is responsible for classifying products as medicines, authorising medicines for lawful supply and enforcing compliance with the regulatory requirements that apply to such products.
3. Dolenio is correctly categorised as a "medicinal product" within the meaning of Directive 2001/83/EC ("the Medicines Directive"). The consequence is that the production and sale of Dolenio is heavily regulated. Indeed it is a prescription only medicine which cannot lawfully be purchased over the counter.
4. The Claimants complain that the Defendant wrongly refuses to treat as medicinal products the large number of GCPs described as "food supplements".
5. The Claimants challenge the Defendant's refusal to treat all GCPs consistently as medicinal products; alternatively the Claimants contend that all GCPs marketed with a daily recommended dose of 1500mg (the Dolenio dose) and/or in quantities which are plainly intended to make it easy for consumers to take that daily dose are medicinal products. It is the Claimants' case that "there is no material difference for these purposes between the authorised and unauthorised GCPs" (Detailed Statements of Facts and Grounds for seeking judicial review, para 6).
6. The Claimants seek a declaration that all GCPs are medicinal; or a declaration that all GCPs with a daily recommended dose of 1500mg are medicines; and an order quashing the MHRA decision not to take enforcement action against all such GCPs.
7. By a proposed amendment, the Claimants also seek a declaration that the MHRA's policy, as disclosed by the Defendant's letter of 19 March 2014, of failing to conduct any case by case analysis as to whether unauthorised GCPs fall within the functional limb of the definition of medicinal products (see para 17 below) is unlawful.

The Factual Background

8. On 9 June 2009 the Defendant, acting through the MHRA, granted the First Claimant a UK marketing authorisation ("MA"), following the Mutual Recognition Procedure with Denmark acting as the reference Member State. The product was described as: "Dolenio 1500mg Film Coated Tablets".
9. Each Dolenio tablet contains 1884.60mg of glucosamine sulphate sodium chloride. 1500mg of the tablet is glucosamine sulphate, of which 1178mg is glucosamine, the active ingredient.
10. Glucosamine is a substance which the human body synthesises from glucose. It is a component of cartilage, bones, tendons and ligaments. Glucosamine is found in the shell of crustaceans or can be obtained from wheat or maize. It is the glucosamine from shellfish that is commonly used in most products on the UK market. There are no known naturally-occurring food sources of glucosamine.
11. In addition to Dolenio, other GCPs have MAs in the UK but only two are available on the market, both of which, like Dolenio, are prescription only medicines for the treatment of mild to moderate OA:

i) Navamedic ASA has, since June 2007, held a MA for Glucomed (marketed in the UK as "Alateris"). Glucomed is presented in the form of tablets containing 625mg of glucosamine (in the form of 750mg of glucosamine hydrochloride), the recommended daily dose of which is 1250mg of glucosamine (or 1500mg of glucosamine hydrochloride).

ii) Tenlec Pharma Ltd has, since 26 October 2009, held a MA for Glusartel, a powder in sachet form containing 1178mg glucosamine (in the form of 1500mg glucosamine sulphate).

12. GCPs not authorised under the Medicines Directive ("unauthorised GCPs") have been on sale in the UK since 1989 as food supplements. They have long been treated as non-medicinal products for the purposes of the Medicines Directive and its predecessor. Glucosamine has been a popular food supplement in the UK and other parts of Europe for many years. These GCPs are sold in various dosages. There are some 800 GCPs on the UK market. Annual retail sales of GCPs are in the region of £55-60 million. Unauthorised GCPs do not have to comply with the extensive regulatory controls in the Medicines Directive governing the manufacture, distribution, sale, marketing and provision of information which govern authorised GCPs. However they are subjected to other regulatory regimes (see paras 29-36 below).
13. Doctors may prescribe, within the limits set by NHS Regulations, medicinal products or food supplements. Similarly, when dispensing products to patients, pharmacists must satisfy the prescription but they otherwise have a degree of discretion in deciding which product to dispense. It follows that unless the doctor has named by brand one of the authorised GCPs on the prescription, the pharmacist is in principle free to satisfy the prescription by dispensing an unauthorised GCP. It appears that the practice of dispensing unauthorised GCPs in response to GCP prescriptions accounts for approximately a fifth of all sales of GCPs.
14. The Claimants first raised the issue which is the subject of the present challenge with the MHRA in 2010. In 2011 the MHRA stated that it had taken action in respect of 186 products which made medicinal claims. However it refused to take action against other unauthorised GCPs which did not make medicinal claims.
15. In late 2012 the Claimants wrote to the MHRA alleging that its enforcement action had proved to be wholly ineffective: the Claimants had noticed no reduction in the number of medicinal claims being made, and if anything considered the situation had deteriorated further. The Claimants also brought to the MHRA's attention the recent report of the European Food Safety Authority ("EFSA") of 2 August 2012 which reviewed its earlier Opinion on this issue, and upheld its findings that:

"a cause and effect relationship has not been established between the consumption of glucosamine and maintenance of normal joint cartilage."

The reason for the conclusion was that all the evidence related to the benefits of glucosamine for subjects with OA. There was no valid evidence demonstrating benefits in the general healthy population.

16. The MHRA responded by a letter dated 6 March 2013 ("the Decision Letter") rejecting the Claimants' contention that all GCPs, or all GCPs with the same active ingredient and dosage as Dolenio, are necessarily medicines; and the contention that the MHRA had acted illogically or unlawfully. The letter continued (at para 27):

"In view of the comments you have made during 2013 the MHRA will once again scrutinise GCP on the UK market. Any product that the MHRA considers to be a medicinal product will be subjected to appropriate and proportionate regulatory action. However, our powers do not extend to requiring non-medicinal products to be labelled with statements that they are non-effective or that they are not medicines. I do not accept that the MHRA has been inactive in this matter; our product scrutiny and the action taken show the contrary is true. The issue of claims for GCP is raised at liaison meetings between the MHRA and relevant Trade Associations and there is a commitment from those Associations to ensure that their members do not market unlicensed medicinal products."

The Legal Framework

I The Medicines Directive

17. Article 1 defines "medicinal product" as

"(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings ['The presentational limb']; or

(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis ['The functional limb']."

18. Article 2 provides, in so far as is material:

"1. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.

2. In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a 'medicinal product' and within the definition of a product covered by other Community legislation the provisions of this Directive shall apply."

19. Article 6 provides, as relevant:

"1. No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EC) No 726/2004…."

20. The Directive contains detailed provisions governing the acquisition of marketing authorisations. Article 8(1) provides that an application for a marketing authorisation must be made to the competent authority of the relevant Member State. Articles 8-12 set out what the application must contain. The basic procedures governing the grant of a marketing authorisation are set out in Articles 17-27.
21. The Directive also contains a procedure, known as the "Mutual Recognition Procedure", governing cases where a person makes an application for marketing authorisation in more than one Member State (see Articles 28-39).
22. The Directive contains other restrictions on medicinal products. They cannot be manufactured in a Member State without a manufacturing authorisation, and the manufacturing process and importation of active ingredients is subject to extensive regulation (Articles 40-53). There are detailed regulations on their labelling and packaging (Articles 54-69).
23. Article 70 provides that, when a marketing authorisation is granted, the competent authorities shall specify whether the product is subject to medical prescription. Article 71(1) provides:

"Medicinal products shall be subject to medical prescription where they:

are likely to present a danger either directly or indirectly, even when used correctly, if utilised without medical supervision, or

are frequently and to a very wide extent used incorrectly, and as a result are likely to present a direct or indirect danger to human health, or

contain substances or preparations thereof, the activity and/or adverse reactions of which require further investigation, or

are normally prescribed by a doctor to be administered parenterally."

24. By Article 76(1) Member States are under a duty to:

"take all appropriate action to ensure that only medicinal products in respect of which a marketing authorisation has been granted in accordance with Community law are distributed on their territory."

25. Further there are restrictions on who may be a wholesaler or distributor of medicinal products, and the standards with which such persons must comply (Articles 76-85). Advertising and the provision of information is governed by Articles 86-100. Member States have extensive powers and duties of supervision and sanction (Articles 111-118).

II Domestic legislation implementing the Medicines Directive

26. At the time when a marketing authorisation was obtained for Dolenio on 9 June 2009 the Medicines Directive, as far as relevant, was implemented domestically by the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994 as amended ("the 1994 Regulations") and sections 58 and 58A of the Medicines Act 1968. The 1994 Regulations were replaced by the Human Medicines Regulations 2012 ("the 2012 Regulations"), which came into force on 14 August 2012.
27. By regulation 323(1) of the 2012 Regulations the Secretary of State must enforce or secure the enforcement of the 2012 Regulations and the relevant EU provisions in England, Wales and Scotland.
28. The parties agree that the 1968 Act, the 1994 Regulations and the 2012 Regulations properly implement the Medicines Directive, in so far as is relevant to the present claim.

III The regulatory framework for foods and food supplements

29. General food law requirements are set out in Regulation (EC) No.178/2002 ("the Food Regulation"). Article 2 of the Food Regulation defines "food" (or "foodstuff") as:

"Any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans."

"Food" includes "any substance intentionally incorporated into the food during its manufacture, preparation, or treatment". Article 2 specifically excludes medicinal products from the definition of a food.

30. The Food Regulation is supported by a number of other regulations governing the manufacturing and inspection process (see, for example, Regulation (EC) 852/2004, Regulation (EC) 853/2004 and Regulation (EC) 854/2004).
31. The Food Supplements Directive 2002/46/EC was implemented domestically pursuant to the Food Supplements (England) Regulations 2003. Article 2 of the Food Supplement Directive defines a food supplement as:

"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."

32. "Nutrients" are defined as "vitamins and minerals". Only vitamins and minerals listed in Annex 1 to the Food Supplements Directive, in the forms listed in Annex II to the Food Supplements Directive, may be used for the manufacture of food supplements. "Other substances" with a nutritional or physiological effect, such as glucosamine, are not yet subject to a positive list under the Food Supplements Directive but such a list may be developed "at a later stage" (see Recital 8 of the Food Supplements Directive). Until such time, "other substances", such as glucosamine, are subject to individual Member State laws but must comply with the requirements set out in the Food Supplements Directive.
33. By Article 6(1) and (2) the Food Supplements Directive requires food supplements to be sold using the name "food supplement", and prohibits their labelling, presentation or advertising from attributing to them the property of "preventing, treating or curing a human disease".
34. Regulation 1924/2006 on nutrition and health claims made on foods ("the Health Claims Regulation") applies to health claims about food in commercial communications, whether in the labelling, presentation or advertising of foods to be delivered as such to the final consumer (Article 1). Article 2(2) paragraph 5 defines a "health claim" as:

"any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health."

A health claim includes a "reduction of disease risk claim" (which is any health claim that states, suggests or implies that the consumption of a food category, a food or one of its constituents significantly reduces a risk factor in the development of a human disease" (see Article 2(2) paragraph 6). Such claims may be authorised by the Commission pursuant to the Health Claim Regulation (Article 14).

35. Article 2(2) paragraph 1 defines a "claim" as:

"any message or representation, which is not mandatory under Community or national legislation, including pictorial, graphic or symbolic representation, in any form, which states, suggests or implies that a food has particular characteristics."

36. The Health Claims Regulation applies to claims made in relation to (i) "nutrients" (defined to include vitamins and minerals), and (ii) "other substances" i.e. "a substance other than a nutrient that has a nutritional or physiological effect" (Article 2(2)).

The Grounds of Challenge

37. The Claimants' primary case is that all GCPs are medicinal products within the functional limb of the definition in the Medicines Directive. In deciding otherwise, and consequently in deciding not to take enforcement action against such products, the Secretary of State has committed an error of law.
38. The Claimants' alternative case is that all GCPs marketed with a daily recommended dose of 1500mg and/or in quantities which are plainly intended to make it easy for consumers to take that daily dose, which is the dose at which authorised medicines GCPs can be used as medicines to treat OA, are medicinal products.
39. The third, additional ground of challenge, is that the MHRA's policy, as disclosed in the letter of 19 March 2014 (see para 7 above), is unlawful.
40. In summary the response of the Defendant is that:

i) The Claimants' primary case would require the MHRA to classify GCPs as medicines without regard to their dosage and without regard to their pharmacological or metabolic effect and their ability to restore, correct or modify physiological functions, which would be unlawful.

ii) The Claimants' alternative case fails to have regard to the MHRA's obligation to assess each branded product on a case by case basis, taking into account the totality of the factors identified by the ECJ in Hecht-Pharma GmbH v Staatliches Gewerbaufsichtsant Luneburg [2009] 2 CMLR 23 ('Hecht'), approving the earlier decision in HLH Warenvertriebs GmbH [2005] ECR I-5141 ('Warenvertriebs').

iii) The Claimants' third ground of challenge is without merit as the MHRA does have regard to the totality of the evidence available to it in relation to the particular product and GCPs in general.

The Parties' Submissions and Discussion

41. Mr Thomas de la Mare QC, for the Claimants, in his oral submissions accepted that the first limb of the relief sought, on the basis of the Defendant's refusal to treat all GCPs as medicinal products, was too wide. Some GCPs will plainly be used at sub-therapeutic levels of dosage. For that reason the Claimants' primary challenge inevitably fails.
42. The real issue for consideration is the Claimants' secondary case that those GCPs which are marketed with a daily recommended dose of 1500mg or in quantities plainly intended to make it easy for consumers to take that daily dose are medicinal products.
43. In support of this submission Mr de la Mare relies on what he describes as eight key facts:

i) GCPs are proven to have beneficial effects in the treatment of mild and moderate OA of the knee. The Committee on Human Medicine Procedure ("CHMP") concluded in its opinion of 13 December 2006, following a referral under Article 29(4) of the Medicines Directive for Glucomed, that:

"Taken together, glucosamine, both hydrochloride and sulphate, has shown efficacy, for the symptomatic relief in patients with mild to moderate osteoarthritis of the knee."

In a letter dated 3 February 2011 on the classification of Glucosamine products in the UK the MHRA wrote to the Claimants' former solicitors:

"CHMP assessed the data, including two long term studies from Spain and Sweden and resolved the matter in favour of Navamedic. The Commission's decision thereafter is addressed to all Member States and accordingly MHRA had an obligation to treat Alateris as a medicinal product, the same obligation exists in respect of Dolenio."

ii) That is why certain GCPs have been granted marketing authorisations. Dolenio and the other GCPs authorised as medicinal products in the UK are prescription-only medicines, indicated for treatment and relief of symptoms in mild to moderate OA of the knee. The intended daily dosage of these authorised products is approximately 1200mg of glucosamine per day.

iii) There are very many unauthorised GCPs on the market in the UK. The NHS PCA data for England for 2011 records that 62 different GCPs (including the three authorised medicines as well as GCPs containing other components such as chondroitin) were dispensed for prescriptions reimbursed in 2008, 79 in 2009, 173 in 2010 and 151 in 2011. In 2011 there were 52,140 prescriptions for generic glucosamine sulphate GCPs which amounts to about 17% of all GCP prescriptions in 2011 (see Mr Aurora's first witness statement, para 51 and his second witness statement, paras 10-16). The leading suppliers of unauthorised GCPs in the UK include high street retailers Boots, Holland & Barratt and Tesco as well as suppliers BR Pharmaceuticals (Valupak), Ransom Consumer Healthcare (Health Perception) and Seven Seas Healthcare. Not only do some suppliers of unauthorised GCPs promote their products as being beneficial for the treatment of OA, in many instances they recommend dosages which would be, and are intended to be, perceived as medically effective (Mr Aurora's first witness statement, para 65). The unauthorised GCPs are substantially identical to the authorised GCPs and are being dispensed invariably in lieu of medicines. There is, Mr de la Mare submits, a de facto unlicensed market. At the same time there is an extra cost to the NHS due to dispensing of unauthorised GCPs, as the reimbursement prices for dispensing unauthorised GCPs are higher than those for authorised GCPs (see Mr Aurora's first witness statement at paras 93-96).

iv) Medicinal products are subject to a strict regulatory regime governing their safety, efficacy, quality and manufacture and also their supply and advertising, as well as monitoring as to their safe use. By contrast the regulation of the manufacture, supply and advertising of "food supplements" is considerably more limited. Yet all GCPs carry materially identical risks (see Mr Aurora's first witness statement at paras 79-92).

v) If a prescription is written generically then a pharmacist may dispense an unauthorised GCP. However the pharmacist would not do so unless there is substantial identicality between the prescription and the unauthorised GCP. The purpose for which such unauthorised GCPs would be used would be medicinal. Further, the total number of unauthorised GCPs on the UK market suggests that many unauthorised GCPs are not dispensed against prescription. This suggests there is self medication. Moreover the medical claims, at least in the past, for food supplements are likely to result in consumers using unauthorised GCPs for medicinal purposes, despite the scientific conclusions that they have no effect on subjects without OA.

vi) There has been no proper investigation by the MHRA of the some 800 GCP that they suggest are on the UK market, as there should have been after the decision of the ECJ in Laboratoires Lyocentre v Lääkealan Turvallisuus-ja Kehittämiskeskus [2003] ECR I-0000, 3 October 2013 (see para 53 below). Mr Carter in his first witness statement states that action has been taken against GCPs which claim to treat or prevent a variety of joint pains and conditions, including problems with the knee (para 38). Mr Carter identifies (at para 39) particular factors relevant to the MHRA's conclusions in relation to GCPs. He states, inter alia, as follows:

"e. … The averagely well-informed consumer is now very used to the huge variety of supplements available in tablet and capsule form and is clear in their own mind that these are not medicinal products, particularly when the substance in that tablet or capsule is found naturally in their own body. Glucosamine has a role in the production of cartilage, and this decreases with age. It is therefore entirely reasonable that a healthy individual would wish to ensure that they maximise the production of cartilage, for example an amateur sports person or simply a keen walker. Such persons would not see themselves as requiring a medicinal product but would rather see themselves as ensuring that their diet contains all the substances their body might reasonably require.

f. Whilst there is evidence that non-medicinal GCPs are used by pharmacists to fill doctors' prescriptions, this represents… only a small fraction of the total market for GCPs."

Mr de la Mare submits that sub-paragraph (e) is pure assertion, inconsistent with the evidence and generic in nature. Further it does not take account of scientific opinion that glucosamine has no health benefit for persons other than those with mild to moderate OA and, unlike vitamins, no nutritional purpose whatsoever. Further, as for sub-paragraph (f) it is not explained, Mr de la Mare submits, why 17% is a "small fraction"; nor is it explained why unauthorised GCPs are in fact used for medicinal purposes.

vii) The fact that popular products such as Vitamin D3 and Vitamin C are sold both in licensed medicines and as food supplements, and there are examples of such products where the non-medicinal amount is larger than the medicinal dosage, is not to the point. Salt, bran/fibre, and vitamins have legitimate uses as food supplements in relation to which health claims can be made, whereas unauthorised GCPs, save for persons with mild to moderate OA, do not.

viii) There are real public concerns arising, in particular, from the use of unauthorised GCPs through self medication and by reason of the less strict regulatory regime that exists for non-medicinal products (see Mr Aurora's first witness statement at paras 87-92).

44. Mr de la Mare advanced six propositions of law which he submitted were relevant to these proceedings. Very helpfully he reduced them to writing. They are as follows:

i) A product falls to be classified as "medicinal" if it falls "within one or other of … two definitions", that is if it is a medicine "by presentation" or a medicine "by function" (Warenvertriebs at para 49; and Lyocentre at para 36). These two definitions are not "strictly separate", since if a product is endowed with properties for "treating or preventing disease" but not presented as such, it would fall within the functional limb (Commission v Germany (Re Eye Lotions) [1995] 2 CMLR 65 at para 14).

ii) As to the presentational limb, this "must be broadly construed" in order to "preserve consumers … from a variety of products used instead of the proper remedies". Thus, it includes express indications or recommendations as well as situations where "an averagely well informed consumer gains the impression … that the product in question should … have an effect such as is described by [Article 1.2[a]" (Officier Van Justitie v Leendert Van Bennekom [1983] ECR 3883 at paras 17-18).

iii) As to the functional limb, a product should not be classified as medicinal—and given a marketing authorisation on this basis—if it "do[es]not significantly affect the metabolism and … modify the way in which [the human body] functions". It must have been "scientifically established" that a product is capable of "appreciably restoring, correcting or modifying physiological functions in human beings". (Hecht at paras 26 and 41-42; BIOS Naturprodukte GmbH v Saarland [2009] ECR I-03785 at para 23; and Chemische Fabrik Kreussler & Co GmbH v Sunstar Deutschland GmbH [2012] ECR I-000 at para 30). To satisfy the functional test, "it is not sufficient that product [sic] has properties beneficial to health in general, but it must strictly speaking have the function of treating or preventing disease". (Commission v Germany (Re Garlic Preparations in Capsule Form) [2008] 1 CMLR 36 at para 64).

iv) When assessing whether a product falls within the functional limb, "the normal conditions of use of the product in question should be taken into account" – including the dosage which is indicated in the instructions or on the packaging of the product (BIOS at para 22). The court must proceed on the assumption that the product will be "used as intended" (Hecht at para 42; and BIOS at para 23).

v) National authorities, "acting under the supervision of the courts" must determine whether a product falls within the functional definition "on a case by case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological properties, to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail" (Warenvertriebs at paras 30 and 51; and Hecht at paras 32 and 39). To that end, national authorities cannot apply "a general rule… applicable without distinction" or "applied systematically to all products" (Commission v Germany (Re Vitamin Supplements) [2006] 3 CMLR 16 at para 59; and Commission v Spain (Re Marketing of Herbal Medicines) [2009] 2 CMLR 52 at para 76).

vi) However, "within the same Member State", once a product has been classified as medicinal, if another product falls to be assessed which "has several of the significant characteristics set out in Article 1(2)(b) of [the Medicines Directive]" and is identical to the first product or "has in common with it an identical substance and the same mode of action", the burden shifts: the national authority must treat the products alike unless it can point to "another characteristic specific to that product" that means it must be classified differently (Lyocentre at paras 58 and 60).

45. It is common ground that the MHRA is required to apply the HLH Warenvertriebs multi-factorial test stated by the ECJ at paragraph 30 of its judgment in the following terms:

"For the purposes of determining whether a product must be classified as a medicinal product or as a foodstuff within the meaning of the Community regulations, the competent national authority must decide on a case-by-case basis, taking account of all the characteristics of the product, in particular its composition, its pharmacological properties, to the extent to which they can be established in the present state of scientific knowledge, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail."

46. Importantly, in my view, the case law of the Court of Justice suggests that the purpose for which a product is used and/or marketed ("the manner in which it is used") is often a critical factor in distinguishing between medicinal and non-medicinal products. In Commission v Germany (Re Garlic Preparations in Capsule Form) [2008] 1 CMLR 36 the Court stated:

"61. Contrary to the definition of medicinal product by presentation, whose broad interpretation is intended to protect consumers from products which do not have the effectiveness they are entitled to expect, the definition of medicinal product by function is designed to cover products whose pharmacological properties have been scientifically observed and which are genuinely designed to make a medical diagnosis or to restore, correct or modify physiological functions.

62. Such an interpretation is in accordance with the aims of Directive 2001/83 which, as is clear from the second to the fifth recitals in the preamble, seeks to reconcile the aim of protection of public health with the principle of free movement of goods.

63. Furthermore, although only the provisions of Community law specific to medicinal products apply to a product which satisfies the conditions for classification a medicinal product, even if it comes within the scope of other, less stringent Community rules (see, to that effect, Delattre at [22]; Monteil at [17]; Ter Voort at [19]; and HLH Warenvertrieb at [43]), it must be stated, as is shown by a reading of Art.1(2) of Directive 2001/83 in conjunction with Art.2 of Directive 2002/46, that the physiological effect is not specific to medicinal products but is also among the criteria used for the definition of food supplements.

64. In those circumstances, and in order to preserve the effectiveness of that criterion, it is not sufficient that product has properties beneficial to health in general, but it must strictly speaking have the function of treating or preventing disease."

47. In the more recent case of Chemische Fabik Kreussler, concerned with the meaning of the term "pharmacological action", the Court added at paragraph 34:

"It is also important to bear in mind that, as well as the pharmacological, immunological or metabolic properties of the product in question, which constitute the factor on the basis of which it must be ascertained, in the light of the potential capacities of the product, whether it may, for the purposes of Article 1(2)(b) of Directive 2001/83, be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions, account must be taken, in determining whether a product falls within the definition of a medicinal product 'by function' for the purposes of that provision, of all the characteristics of the product, including, inter alia, its composition, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail (see BIOS Naturprodukte, paragraphs 18 and 20)."

48. Products must not be classified as medicinal on a "blanket" basis under the functional limb; the multi-factor Warenvertriebs test must be applied in each case (see Commission v Spain (Re Marketing of Herbal Medicines) at paras 72 and 79).
49. In Commission v Germany (Garlic Capsules) the Court of Justice made clear the importance of considerations of proportionality in the context of the classification of products as medicinal under the functional limb:

"71. As the Commission has observed, the Community provisions relating to medicinal products must ensure, in addition to the protection of human health, the free movement of goods, so that the interpretation of the provisions of Directive 2001/83 in general, and the definition of medicinal products in particular, cannot result in obstacles to the free movement of goods which are entirely disproportionate to the pursued aim of protecting health."

50. Not only medicines but also foods and food supplements produce physiological effects on the human body. Further, they may resemble medicines in their product form as tablets or capsules. However, taking a supplement is merely a convenient way for a person to add to their diet (see paras 31-32 above for the definition of food supplements in Directive 2002/46/EC).
51. Mr Andrew Henshaw QC, for the Defendant, points to the distinctions drawn by EU legislation by reference to the way in which products are presented and used: (1) the presentational limb in the Directive applies to products presented as having properties "for treating or preventing disease"; (2) the functional limb in the Directive applies to products used "with a view to restoring, correcting or modifying physiological functions"; (3) the Food Supplements Directive requires food supplements to be sold using the name "food supplement", and by Article 6(1) and (2) prohibits their labelling, presentation or advertising from attributing to them the property of "preventing, treating or curing a human disease" (see para 33 above); (4) Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs lays down procedures in matters of food safety; and (5) the Health Claims Regulation applies to "health claims" including "reduction of disease risk claims" (see paras 34-36 above).
52. Mr de la Mare submits, relying on the decision of the Court of Justice in Laboratoires Lyocentre, that the consequence of the categorisation of some GCPs as medicinal products is that other GCPs, which contain an identical substance and the same mode of action, must also be categorised as medicinal products unless they have specific characteristics which preclude such classification.
53. In Laboratoires Lyocentre the Court stated that:

"58. To the extent that another product has several of the significant characteristics set out in Article 1(2)(b) of Directive 2001/83, namely, where it has one of the same substances and the same mode of action as the product classified as a medicinal product, the former should, in principle, also be classified and marketed as a medicinal product. That being the case, it is for the referring court to verify, on a case by case basis, as referred to in paragraph 42 above, that another characteristic that is specific to that product and relevant for the purposes of Article 1(2)(a) of Directive 93/42 does not preclude the product from being classified as a medicinal product and marketed as such.

59. It should, moreover, be recalled that Article 2(2) of Directive 2001/83 states that, in cases of doubt, where, taking into account all of its characteristics, a product may fall within the definition of a 'medicinal product' and within the definition of a product covered by other Union legislation, it must be classified as a medicinal product.

60. In the light of the foregoing considerations, the answer to the third question is that, within the same Member State, a product, which, while not identical to another product classified as a medicinal product, nonetheless has in common with it an identical substance and the same mode of action, cannot, in principle, be marketed as a medical device in accordance with Directive 93/42, unless as a result of another characteristic that is specific to that product and relevant for the purposes of Article 1(2)(a) of Directive 93/42, it must be classified and marketed as a medical device, which is a matter for the referring court to verify."

54. In my view this decision does not assist the Claimants. The court in that case was concerned with the borderline between medical devices (covered by Directive 93/42) and medicinal products. The court stated (at para 8):

"Article 1(5)(c) of Directive 93/42 provides that the directive is not to apply to medicinal products covered by Directive 2001/83. For the purpose of deciding whether a product falls under that directive or Directive 93/42, particular account is to be taken of the principal mode of action of the product."

As Mr Henshaw observes, since the principal mode of action is the critical dividing line between medical devices and medicinal products, it is logical that products with the same mode of action should in principle be classified in the same way absent a specific reason to take a different approach.

55. These considerations have no application to the borderline between food supplements and medicinal products. Indeed the court in Laboratoires Lyocentre (at para 42) reiterated the multi-factorial test that must be applied on a case by case basis, having regard to all their relevant characteristics when considering whether a product falls within the definition of a medicinal product.
56. Article 2(2) of the Medicines Directive also does not advance the Claimants' argument. In Hecht the Court stated at para 24:

"It is clear from recital 7 in the preamble to Directive 2004/27 that art.2(2) was inserted into Directive 2001/83 in order to make clear that when a product falls within both the definition of a medicinal product and that of other regulated products, it must be made subject to the provisions of Directive 2001/83. Thus, art.2(2) of Directive 2001/83 starts from the premise that the product concerned satisfies the conditions for classification as a medicinal product (see, to that effect, HLH Warenvertriebs and Orthica at [43] and [44])."

57. Applying the multi-factorial test in each case involves a mixture of factual and scientific considerations. The task of the MHRA, as the competent authority, is a complex one, in particular in relation to "borderline" products. As Lord Woolf MR observed (at para 27) in R v Medicines Control Agency, ex parte Pharma Nord (UK) Ltd [1998] 3 CMLR 109, in relation to the predecessor to the Medicines Directive:

"…the application of the definition of a medicinal product in Article 1(2) of the Directive is far from straightforward. Where it is the functional qualities of the product which are in issue, there will be room for more than one opinion and it must be very much a question of judgment in those cases where the answer is not obvious whether a product is medicinal or not."

Lord Woolf added (at para 41):

"4. Both the determination of the facts and the application of the policy in a case such as this is not ideally suited to the adversarial processes of the courts. If the case was one where the MCA could not reasonably have come to the decision which it did so that the outcome was one which is conventionally determined on applications for judicial review the position would be different. However in this case the MCA is in a better position to evaluate the evidence than a judge. It has accumulated experience in relation to other products which a court lacks. It is an expert body. The MCA has to develop a consistent policy between similar products. The issues are, to use Simon Brown LJ's approach, ones in relation to which the court should be wary of becoming involved."

58. I do not accept Mr de la Mare's submission that this approach has no application in the present case because there is no issue on the scientific evidence as to the medicinal effect of a daily dosage of 1500mg of glucosamine. There are other important elements of the multi-factorial test that have to be considered which require the skill and judgment of the MHRA.
59. The Claimants accept that some consumers purchase unauthorised GCPs for perceived health benefits, but they emphasise that they actually have no proven benefit for healthy people (see para 15 above). The only proven benefit of glucosamine is its use in the treatment of OA. It has no other proven benefit, whether medicinal or other health benefits as a food supplement. Indeed since 2 January 2014 companies are no longer entitled to make health claims for GCPs. However it does not follow that GCPs must therefore be viewed as medicinal. I accept Mr Henshaw's submission that a product which is found to be an ineffective food supplement, because of lack of proven nutritional or physiological effect, is not necessarily a medicine. It may simply be an ineffective food supplement. It will constitute a medicine only if it satisfies the distinct test for medicinal products set out in the Directive.
60. The Food Supplements Directive contains no requirement in relation to the efficacy of food supplements. Products may be sold as food supplements whether or not a health claim has been made for them, or can be justified. Moreover the process for obtaining authorisation for health claims under the Health Claims Regulation is rigorous (see Articles 5-19). The fact that a health claim has not been authorised for a product does not, necessarily, demonstrate that it is ineffective, but only that its efficacy has not so far been proven by reference to generally accepted scientific data.
61. Whilst it is unlawful to market unauthorised GCPs for medicinal purposes, Mr de la Mare submits that the evidence shows that in practice a significant proportion of unauthorised GCPs are purchased for medicinal purposes and used as medicines. Moreover very many unauthorised GCPs are dispensed against doctors' generically written prescriptions for GCPs (see para 43 above). These are, he submits, highly relevant factors to which regard should be had when considering whether those products are properly to be categorised as medicinal.
62. In fact, as the decision letter of 6 March 2013 notes, many GCPs have been sold as food supplements for over twenty years in the UK, and in August 2004 the UK's Food Standards Agency noted that the most widely recommended intake for glucosamine hydrochloride was up to 1500mg per day. There has been a well-established market for GCPs dating from long before any GCPs received a marketing authorisation. It is, in my view, clear from the evidence that GCPs without marketing authorisations are predominantly marketed as daily supplements which help to maintain healthy joints (see witness statement of Mr Aurora and the descriptions in exhibit SA-1). Health claims do not provide evidence of medicinal use. Where promoters of GCPs make medicinal claims the evidence indicates that the MHRA do take action against them. Between 1992 and 6 March 2013 the MHRA took action against at least 96 companies. The MHRA do not accept that their enforcement efforts in relation to medicinal GCP have been ineffective.
63. Further, to the extent that GCPs, with or without marketing authorisations, are dispensed to fill prescriptions (approximately £10.21 million in 2011 on the Claimants' case), they represent less than a fifth of the total market for GCPs which was about £57.8 million in 2011. It follows, Mr Henshaw submits, that far more glucosamine is sold as a food supplement than is obtained on prescription. I accept Mr Henshaw's submission that in those circumstances it is not legitimate to deduce that customers in general regard GCPs as medicinal. This is particularly so because GCPs have for many years been marketed and purchased for use for non-medicinal purposes as food supplements. Further, doctors are permitted to prescribe food supplements. I accept Mr Henshaw's submission that, that being so, the fact of prescription is not necessarily indicative of medicinal use. I am not persuaded that the evidence on which the Claimants rely as to the practice of dispensing unauthorised GCPs in response to GCP prescriptions (see Mr Aurora's first witness statement, in particular, paras 47-50 and 93-96, and his second witness statement, paras 9-24) shows that pharmacists and the relevant patients consider GCPs to be medicines, as the Claimants suggest (see to the contrary, in particular, Mr Carter's first witness statement, paras 44-66, and the "Defendant's data analysis").
64. Mr de la Mare suggests there is no material difference between Dolenio and unauthorised GCPs in terms of risks. The known risks of glucosamine are set out in the patient information leaflet provided with each packet of Dolenio. Dolenio and unauthorised GCPs contain the same active ingredient. If anything, he submits, the risk posed by unauthorised GCPs is higher since they are manufactured and distributed subject to lower standards of control than is the case with authorised medicines. Moreover purchasers of such products have less warning of the risks as they will not receive any proper patient information leaflet. However the studies and reviews of GCPs have been positive (see Mr Aurora's witness statement, paras 14, 15 and 19 and exhibit SA-1). As Mr Brian Kelly, for the Interested Party, pointed out, there is a comprehensive legislative regime for foods and food supplements. Further, food supplements are subject to a number of specific labelling requirements (see para 33 above, as to Article 6 of the Food Supplements Directive).
65. In my judgment, having regard to the Warenvertriebs multi-factorial test (see para 45 above) and the standard of review to be applied to a decision of the MHRA in a case such as the present (see para 57 above), the Claimants have failed to establish that the MHRA erred in refusing to treat all GCPs, alternatively GCPs marketed with a daily recommended dose of 1500mg, as medicinal products.
66. The additional amended ground of challenge raises the question as to whether the MHRA does in fact conduct, as it maintains it does, a multi-factorial assessment on a case by case basis as required by Warenvertriebs. The Defendant's solicitors in a letter dated 19 March 2014 wrote:

"The MHRA considers that in general, taking into account all the relevant factors pursuant to Directive 2001/83/EC, GCPs marketed and used as food supplements (whether or not the recommended daily dose is similar to that for licensed products) do not fall within the presentational or the functional limb of the definition of medicinal products, for the reasons outlined in Mr Carter's witness statement.

The MHRA's review of individual brands therefore focuses on their presentation and claims made (explicitly or implicitly) for those brands, without a full reconsideration of their ingredients, unless there is new evidence or information about a brand which may have a bearing on its pharmacological, metabolic or immunological effects."

67. Mr de la Mare submits that this statement evidences an unlawful policy in that, in deciding whether a product falls within the functional limb, the MHRA fails to have regard to a number of relevant factors: first, the history of medicinal health claims made in relation to that product; second, the recommended daily usage; third, the similarity of the recommended dosage strength to the doses in authorised products; and fourth, the proportion of consumers using that particular product for medicinal purposes. Each of these factors, he contends, are relevant to whether customers view and use the product in question as a medicine.
68. However Mr Carter, in his second witness statement, made to address these contentions, makes clear that the reference in the letter of 19 March 2014 to "presentation and claims made (explicitly or implicitly)" is not merely to the presentation limb. He states (at para 4):

"The point being made in the letter… is that several of the considerations which arise in relation to the GCPs under the functional limb are common to many or most GCPs – in particular, their typical composition, dosage and physiological effects – and do not require to be revisited for each and every product unless there is evidence of a change in one or other of these respects."

69. Mr Carter makes the following additional points: (1) the MHRA has regard to the previous marketing history of a GCP in certain circumstances where there has been a statutory notice, and in any other case it has regard to the history of claims made in relation to GCPs in general (para 5); (2) he notes that the MHRA is aware that GCPs have been sold as food supplements with recommended daily dosages of 1500mg for many years, since well before the first GCP obtained an MA in the UK in 2007, and that being so the MHRA does not consider that it should be inferred, from a daily recommended dosage at that level, that consumers are likely to regard a GCP as a medicine (para 6); and (3) the MHRA does not receive data on the proportion of consumers using any given particular product for medicinal purposes, but "forms a judgment on the totality of the evidence which is available to it in relation to the particular product and GCPs in general" (para 8).
70. In my view the evidence does not support the claim that has been advanced on the basis of the letter of 19 March 2014 that the MHRA does not conduct a proper case by case assessment of GCPs.

Conclusion

71. For the reasons I have given, this claim fails.