Direct link Share on

In an important judgment on borderline medicinal products, the Court of Appeal has required the MHRA to re-consider whether some Glucosamine products, which are marketed as food supplements, should be treated as medicinal products. The Court held that once a marketing authorisation was granted to a product delivering a particular active ingredient, in this case Glucosamine, at a particular dose, the fact that other products containing the same active ingredient (intended to be used at the same daily dose) were packaged and sold as food supplements could not be treated as determinative of whether or not they were medicines.  Instead it was incumbent on the MHRA to investigate the actual use of such products and if significant numbers of them were in fact being used as medicines to treat joint pain and stiffness associated with osteoarthritis they should be treated as such. The Court accepted that there was strong evidence of such use requiring further investigation by the MHRA, not least given the levels of prescriptions (past and present) for glucosamine for OA joint pain that were being met by food supplements; and the various authoritative bodies that were encouraging or condoning self-medication for OA using glucosamine,  which self-medication was necessarily being done with food supplements, since all of the licensed medicines were prescription only. The Court accordingly found the stance of the MHRA to be Wednesbury unreasonable and overturned the decision of Supperstone J to dismiss the judicial review. Given the very wide use of glucosamine products the decision is of considerable commercial significance.

The full judgment can be read here: http://www.bailii.org/ew/cases/EWCA/Civ/2016/554.html 

Tom de la Mare QC and Tristan Jones acted for the Claimant, Blue Bio.

+44 (0)207 5831770

Clerks

Staff