Blue Bio Pharmaceuticals Ltd & Anor, R (On the Application Of) v Secretary of State for Health (MHRA)

Classification as a medicinal product under the functional limb requires a case-by-case application of the multi-factorial test. A product cannot be classified as medicinal on a blanket basis merely because it has a particular dosage, physiological effect, or similarity to an authorised medicine.

The relevant factors include composition, pharmacological properties, manner of use, distribution, consumer familiarity and risks. The competent authority must exercise judgment, particularly for borderline products, subject to judicial review. An ineffective food supplement does not thereby become a medicine. The fact that food supplements are prescribed or dispensed does not necessarily establish medicinal use. Classification must also respect proportionality and the distinction between food supplements and medicinal products.

The claimants supplied Dolenio, an authorised glucosamine product used in treating osteoarthritis. They challenged the MHRA’s refusal to classify unauthorised glucosamine-containing products marketed as food supplements as medicinal products.

They sought declarations that all such products, or products marketed at a daily dose of 1500mg, were medicinal, together with an order requiring enforcement action. They also challenged an alleged MHRA policy of failing to conduct a case-by-case assessment under the functional limb of the Medicines Directive.

The central questions were whether dosage, composition, dispensing practices, consumer use and the existence of authorised glucosamine medicines required equivalent classification, and whether the MHRA had applied the legally required multi-factorial assessment.

1. The claim was dismissed. The claimants accepted that their primary contention, that all glucosamine-containing products were medicinal, was too broad because some products would be used at sub-therapeutic dosages.

2. The functional limb of the Medicines Directive required the MHRA to apply the multi-factorial test in HLH Warenvertriebs GmbH [2005] ECR I-5141 and Hecht-Pharma GmbH v Staatliches Gewerbaufsichtsamt Lüneburg [2009] 2 CMLR 23. The relevant matters included composition, pharmacological properties, manner of use, distribution, consumer familiarity and risks. A blanket classification was impermissible.

3. The purpose for which a product was used or marketed could be critical, but products could not be classified as medicinal solely because they produced physiological effects or resembled medicines in tablet or capsule form. Food supplements also produced physiological effects, and taking one could simply be a convenient means of supplementing the diet.

4. The decision in Laboratoires Lyocentre v Lääkealan Turvallisuus-ja Kehittämiskeskus [2003] ECR I-0000 did not require all glucosamine products to receive the same classification. That case concerned the boundary between medical devices and medicinal products, where principal mode of action was the critical dividing line. The food supplement question remained subject to a case-by-case, multi-factorial assessment.

5. The fact that glucosamine had no proven benefit for healthy people, or that some products were ineffective food supplements, did not make them medicines. Nor did prescription or dispensing practices necessarily demonstrate medicinal use, since doctors could prescribe food supplements and most sales were made as daily supplements for maintaining healthy joints.

6. The MHRA was better placed than the court to evaluate the factual and scientific material concerning borderline products. The evidence did not establish that it had unlawfully failed to consider relevant factors or had adopted an unlawful policy. Its refusal to classify all products, or all products marketed at 1500mg, as medicinal was therefore lawful.