Blue Bio Pharmaceuticals Ltd & Anor v Secretary of State for Health & Anor

A product falls within the functional limb of the medicinal-product definition only where its pharmacological properties have been scientifically established as capable of restoring, correcting or modifying physiological functions. General health benefits are insufficient.

Classification must be made case by case by considering composition, pharmacological properties, manner of use, distribution, consumer familiarity and risks. A regulator may assess products generically where they share material characteristics, but must not group together products with materially different active ingredients or dosages.

Where evidence indicates widespread medicinal use, the regulator must investigate how the products are used. Equating sale as food supplements with actual use is inadequate and may be unlawful on Wednesbury grounds.

The appellants supplied Dolenio, a glucosamine sulphate product classified by the MHRA as a prescription-only medicinal product. They challenged the MHRA’s refusal to classify other glucosamine-containing products with similar composition, dosage and use in the same way.

Supperstone J rejected the challenge in the Administrative Court in [2014] EWHC 1679 (Admin). The appeal concerned the proper application of the functional limb of the Medicinal Products Directive, the priority rule in article 2.2, the relevance of consistency between products within one member state, and the adequacy of the MHRA’s investigation.

The appeal was allowed. Lewison LJ gave the leading judgment, with McCombe and Longmore LJJ agreeing. The MHRA’s decision was quashed and the classification question was remitted for further consideration.

1. Functional limb. The court held that scientifically established pharmacological properties are a necessary condition for classification as a medicinal product by function. Article 2.2 cannot bring within the Medicinal Products Directive a product which does not satisfy that definition. The court applied the reasoning in Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg [2009] 2 CMLR 23 and Commission of the European Communities v Federal Republic of Germany [2008] 1 CMLR 36.
2. Case-by-case assessment. The Warenvertrieb criteria require assessment of composition, pharmacological properties, manner of use, distribution, consumer familiarity and risks. Article 2.2 means that products sharing several significant characteristics with a product already classified as medicinal should in principle receive the same classification, unless another product-specific characteristic takes them outside the definition. The relevant comparison was between orally ingested products containing glucosamine sulphate at a recommended daily dose of 1,500 mg, not all glucosamine products indiscriminately.
3. Lyocentre. The general principle in Laboratoires Lyocentre v Lääkealan turvallisuus- ja kehittämiskeskus and Sosiaali- ja terveysalan lupa- ja valvontavirasto [2013] ECR I-0000 was relevant. However, its particular same-mode-of-action test was specific to the boundary between medicinal products and medical devices and did not govern the food-supplement boundary.
4. Investigation and judicial review. Manner of use includes why products are used. The MHRA wrongly treated the whole class of glucosamine-containing products generically, equated the manner in which products were sold with their actual use, and closed its mind to evidence suggesting widespread self-medication. Its failure to investigate the relevant Warenvertrieb factors was susceptible to challenge on traditional Wednesbury grounds, applying R v Medicines Control Agency, Ex p Pharma Nord (UK) Ltd [1998] 3 CMLR 109 and R (London Criminal Courts Solicitors’ Association) v Lord Chancellor [2015] EWHC 295 (Admin).
5. Scope of remittal. The MHRA was not required to investigate every brand separately. It was required to investigate the use of the relevant group of products sharing glucosamine sulphate and the 1,500 mg daily dosage, while considering whether differences such as the stabilising agent created a material distinction.

1. Court of Appeal (Civil Division). The appeal was allowed. The MHRA decision was quashed and the classification question was remitted for further consideration: [2016] EWCA Civ 554.
2. High Court of Justice, Queen’s Bench Division, Administrative Court. Supperstone J rejected the appellants’ challenge to the MHRA’s classification approach: [2014] EWHC 1679 (Admin).