“a cause and effect relationship has not been established between the consumption of glucosamine and maintenance of normal joint cartilage.”
“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.”
“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.”
“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….”
“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.”
“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.”
“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”
“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.”
“any claim that states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health.”
“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.”
“Taken together, glucosamine, both hydrochloride and sulphate, has shown efficacy, for the symptomatic relief in patients with mild to moderate osteoarthritis of the knee.”
“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.”
“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.”
“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.”
“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).”
“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.”
“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.”
“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.”
“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 Warenvertriebsand Orthica at [43] and [44]).”
“…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.”
“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.”
“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.”
“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.”