High Court rejects judicial review application seeking to classify glucosamine products as medicines

23/05/14

Blue Bio Pharmaceuticals and another v Secretary of State for Health

The Claimants hold marketing authorisations permitting them to sell certain glucosamine-containing products (“GCPs”) as medicines for the treatment of osteoarthritis of the knee.Glucosamine is a component of cartilage, bones and tendons, which the body can synthesise from glucose.Many other GCPs, often similar or identical in chemical composition to medicinal GCPs, have been widely sold as food supplements for joint health for about 25 years.

The UK’s medicines regulator, the MHRA, has taken action to prevent the sale for medicinal use of GCPs without marketing authorisations.It has, however, declined to classify as medicines GCPs used as food supplements.

The Claimants applied for judicial review, contending that (a) all GCPs are medicines, (b) all GCPs sold with a daily recommended dose equivalent to that for medicinal GCPs are medicines and/or (c) the MHRA has failed to carry out a proper case by case review in accordance with the Medicinal Products Directive (Directive 2001/83/EC) and relevant case law.

The Administrative Court (Supperstone J) dismissed the Claimants’ claims.  The Court held that (1) the Court of Justice’s decision in Case C-109/12 Laboratoires Lyocentre does not (as the Claimants contended) create a presumption that a product is a medicine when its composition and mode of action are the same as those of an authorised medicine; (2) the MHRA was entitled to have regard to the purpose of use when deciding whether GCPs are medicines under the “functional limb” of the Directive; (3) the predominant use of GCPs is as food supplements, although a proportion of them are dispensed against GPs’ prescriptions; and (4) the MHRA’s case by case review of GCPs was adequate.

The judgment is here.