In a Judgment handed down on 22 May 2014, the English High Court refused an application for judicial review of the UK's Medicine and Healthcare Products Regulatory Agency ("MHRA") decision not to categorise all glucosamine-containing products ("GCP") as medicines.
The Claimants were the holders of a UK marketing authorisation for Dolenio, a GCP used in the treatment of osteoarthritis ("OA"). Dolenio was categorised as a 'medicinal product' within the meaning of Directive 2001/83/EC (the "Medicines Directive") and as a prescription-only drug its production and supply was heavily regulated. The recommended daily dosage of glucosamine for the treatment of OA is 1,500 mg. A 2012 European Food Safety Authority ("EFSA") report found that no relationship had been established between the consumption of glucosamine and maintenance of normal joint cartilage. All the evidence of medical benefits related to patients with OA not the general population.
The complaint centred on the fact that there are a number of GCPs which were available to UK consumers as food supplements in similar dosage strengths. Such food supplements had been available in the UK for many years. Although these supplements were not authorised as medicines, the practise of some UK pharmacists was to satisfy prescriptions by dispensing the cheaper unauthorised GCPs as substitutes for Dolenio. It was estimated that in 2011 about 17% of prescriptions were filled in that way.
While the MHRA had taken steps in respect of 186 unauthorised GCPs that had made medicinal claims, it refused to take action against those sold without any medicinal claims.
The Medicines Directive contains a presentational and functional definition of medicinal product (Article 1). The functional limb applied to 'any substance ... administered to humans ... with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological... action'. The stringent requirements and restrictions set out in the Medicines Directive only apply to medicinal products. The Claimants argued that all GCPs were medicines within the functional definition of the Medicines Directive. In the alternative, the Claimants asserted that all GCPs marketed with a daily recommended dose of 1,500 mg (or at a dose which made it easy for consumers to take that dose) should also be treated as medicinal products.
The legal requirements for food and foodstuffs are governed by Regulation No. 178/2002(the "Food Regulation"); medicinal products are specifically excluded under Article 2. TheFood Supplements Directive 2002/46/EC defines a food supplement as foodstuffs which supplement a normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physical effect (Article 2). Nutrients are defined as vitamins and minerals and listed in Annex I in the forms listed in Annex II to the Food Supplements Directive. Glucosamine does not fall within this list and being categorised as an "other substance" is therefore subject to national law (which must comply with the Food Supplement Directive). Under Article 6(1) and (2), food supplements must be labelled as such and must not be labelled, presented or advertised as 'preventing, treating or curing a human disease'. The regulatory requirements of the manufacture, supply and advertisement of food supplements are much more limited in comparison to the medicines regime.
Regulation No. 1924/2006 on nutrition and health claims made on food (the "Health Claims Regulation") defines a health claim as 'any claim that suggest or implies that a relationship exists between a food category, a food or one of its constituents and health'. Health claims include those claims which suggest or imply that consumption significantly reduces a risk factor of a disease (Article 2(2)). The Health Claims Regulation applies to nutrients and 'other substances'.
It was common ground that the MHRA was required to apply the multi-factoral test set by the CJEU in HLH Warenvertriebs GmbH (para 30,  ECR I-5141) which stated that for the purposes of determining whether a product must be classified as a medicinal product or as a foodstuff, the competent national authority must decide on a case-by-case basis, taking account of all of the characteristics of the product, in particular its composition, its pharmacological properties (to the extent scientifically known), the manner in which it is used, the extent of distribution, its familiarity to consumers and the risks which its use may entail.
In the Judge's opinion, the CJEU case law suggested that it was the purpose for which a product was used and/or marketed which was often a critical factor in distinguishing between medicinal and non-medicinal products. The functional limb covered products whose pharmacological properties had been scientifically proven to have physiological effects. However, such physiological effects were not specific to medicinal products but were also among the criteria recognised within the definition of food supplements. Thus to fall within the functional limb, the criteria extended beyond mere health benefits, a product must treat or prevent disease. Products could not be classified as medicinal on a 'blanket' basis under the functional definition of medicinal product. The approach must be proportional. The fact that some GCPs were classified as medicinal products did not mean that all other GCPs containing an identical substance and mode of action must also be classified in the same way. The multi-factoral test involved the application of complex factual and scientific considerations by the MHRA, particularly in respect of 'borderline' products.
Although there was no proven health benefit of GCPs for healthy people, it did not follow that a food supplement that was ineffective in that population because no nutritional or physiological effect had been proven must be viewed as a medicine. It might simply be an ineffective food supplement. Indeed, the Food Supplement Directive does not require food supplements to be proven to be effective. The evidence was that unauthorised GCPs were predominantly marketed as daily supplements which help maintain healthy joints. The evidence showed that in that context, where GCPs had been labelled with medicinal (rather than health) claims, the MHRA had taken action. Prescriptions for GCPs (authorised or not) represented one-fifth of the total market for GCPs. Accordingly it did not follow that consumers regarded GCPs as medicinal.
Given the standard of review to be applied to a decision taken by the MHRA, the Judge held that the Claimants had not established that the MHRA had erred in refusing to treat all GCPS, or those marketed at a daily dose of 1,500 mg, as medicinal products. The Judge also held that there was no evidence of the MHRA failing to conduct a case-by-case analysis of GCPs.