The court said the UK Medicines and Healthcare products Regulatory Agency (MHRA) needed to re-examine how glucosamine supplements, especially those at doses of 1500 mg or more, were being used in self-medication scenarios.
The agency, along with the food supplements industry that markets 100s of glucosamine products, said it was ‘disappointed’ by the ruling, given the agency’s ‘case-by-case’ position that the joint health nutrient could exist as both a food supplement and a medicine, depending principally on dosage and usage.
“The most innovative point of the ruling relates to the intended use of products marketed as food supplements,” said Dr Luca Bucchini, founder of Rome-based Hylobates Consulting.
“Regardless of classification as food supplements, the MHRA should have investigated whether consumers were using the products as medicines.”
Dr Bucchini added: “If this principle were widely accepted, it would be a significant change because research shows that a minority of food supplements are indeed used for self-medication. This could lead to many classification decisions which are difficult to enforce in practice. It is a scrupulous and interesting ruling.”
Dr Bucchini said however that glucosamine supplement players could take heart from the ruling as it did not expressly state that all glucosamine products should be classified as medicines.
“In fact, the ruling notes that they may have different characteristics, and, if the recommended dosage is different, that would be a significant difference; additives used also matter to bioavailability and hence to classification. Interestingly, the lack of an authorised health claim has played a role in the decision.”
There are no EU-approved claims under the 2006 nutrition and health claims regulation (NHCR) for glucosamine nor fellow joint health nutrient chondroitin, which the Court acknowledged, and which it said removed a potential point of differentiation between supplements and medicinal products.
Harmonisation
The ruling may provoke greater harmonisation in the EU, Dr Bucchini said, referencing melamine as an example of a nutrient whose EU status was fragmenting.
“The upshot is that while the supplements/drugs borderline issue is always going to be complicated, we need regulation and harmonisation in this area. A functioning single market requires rules, and leaving the matter entirely in the matters of national courts - even if competent - creates an array of problems to most stakeholders.”
“Hopefully stakeholders will be convinced that it is time to act. Or maybe the European Court of Justice (ECJ) will have something to say about it.”
The appeal was brought by Chinese pharma player Blue Bio (Yantai) Pharmaceuticals after its previous attempt to have glucosamine products classified as medicines was rejected in the UK High Court in 2014.
Blue Bio is since 2009 the holder of a prescription-only medicines registration across the EU’s 28 member states for its glucosamine sulphate product, Dolenio. It sought to close the glucosamine supplements channel completely in the UK.
The full Court of Appeal ruling is here: