In late December 2016, the Supreme Court rejected the Medicines and Healthcare Products Regulatory Agency's (MHRA) application for permission to appeal against the decision of the Court of Appeal in R. (on the application of Blue Bio Pharmaceuticals Ltd) v Secretary of State for Health,  EWCA Civ 554. In its unanimous decision of June last year, the Court of Appeal (i) quashed the MHRA's decision not to classify certain glucosamine-containing products (GCPs) as medicinal products, and (ii) remitted to the MHRA the question whether some or all GCPs should be classified as medicinal products.
The Court of Appeal took the view that there was an error in the practice adopted by the MHRA when deciding whether or not unauthorised GCPs, so-called 'borderline products' (products on the borderline between medicinal products and food supplements) and widely sold as food supplements but apparently used for medicinal purposes, should be regarded as medicinal products (and therefore subject to a more strict regulatory regime).
The Court of Appeal's judgment is significant and is therefore likely to have wider implications, beyond GCPs. Marketing and placement of borderline products in the UK as food supplements may need to be revisited following this decision, in particular once the MHRA introduces changes to its practice following the judgment.
GCPs are one of the UK's top-selling 'food supplements'. Curiously however, the active ingredient, glucosamine, is not obtainable as part of a diet; nor is it a "nutrient" or other substance with any proven effect other than a medicinal one, namely for the treatment of osteoarthritis of the knee.
Manufacturers and suppliers which currently sell or plan to sell borderline products as food supplements in the UK should note the following:
Many glucosamine products are likely to be re-classified as medicines and regulated as such
The Court of Appeal decided as follows:
GCPs having the three elements set out below share the key characteristics of a GCP currently authorised and marketed in the UK as a medicinal product, namely Dolenio. Those GCPs should therefore be classified as medicinal products in the UK unless they have any other significant characteristic which takes them outside the definition of "medicinal product" under the Medicinal Products Directive 2001/83/EC:
- orally ingested GCPs
- whose active ingredient is glucosamine sulphate
- which have a recommended daily dose of 1,500 mg
In this regard, the court observed that the MHRA had not investigated what proportion of unauthorised GCPs (i.e. GCPs marketed as food supplements) are in fact used for medicinal purposes.
As to the scope of the review to be carried out by the MHRA, the court was of the view that brand by brand assessment is not necessary. Instead, the required investigation may be limited to investigating the manner of use of orally ingested GCPs whose active ingredient is glucosamine sulphate and which have a recommended daily dose of 1,500 mg.
The following comments can be made in light of the court's views set out above:
- As there is currently at least one GCP classified as medicine in the UK (Dolenio), unless this classification were changed by the MHRA, the GCPs on the UK market whose active ingredient is glucosamine sulphate and which carry a recommended daily dose of 1,500 mg will need to be classified as medicinal products unless there is some good reason why the GCPs in question should not be regarded as medicinal products, whether because of the manner in which such GCPs are in fact being used or otherwise.
- The active ingredient of all GCPs is glucosamine itself, irrespective of the specific compound or salt form in question. The MHRA will therefore wish to conduct a broad review of all GCPs sold as food supplements (rather than only the sulphate form).
- For GCPs which are currently sold as food supplements, the questions to be asked are: (i) how do they differ from Dolenio, and (ii) whether the differentiator is such that the second limb of Article 1.2 of the Medicinal Products Directive does not apply, i.e. in the present case whether the GCP is not a substance which may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action.
- The MHRA could decide to apply a different threshold and/or other criteria when deciding whether a GCP ought to be regarded as a medicinal product rather than a food supplement. In view of this, proceeding on the basis that a food supplement containing glucosamine will not be classified as a medicinal product so long as its recommended daily dose is less than 1,500 mg is not without a risk of the product nonetheless being classified as a medicinal product.
- If a product is a medicinal product, the regulations on food and food supplements do not apply. A change in the classification from food to medicine will result in significant changes to the way in which the product can be manufactured and marketed (for example the packaging, labelling and information provided), as well as of course the need for the product to be authorised by the MHRA before it can be placed on the market.
Closer review by the MHRA in deciding whether a product is a medicinal product
The Court of Appeal decided that, on the facts, the MHRA has to date dealt with the assessment of unauthorised GCPs generically by collectively assessing products which do not share significant characteristics of Dolenio and in particular its active ingredient (glucosamine sulphate) or its recommended daily dosage. Dealing with GCPs generically in this manner was "an error of law".
The following comments can be made in light of the court's view set out above:
- The evidence that will be gathered and considered by the MHRA in making its assessment as to whether a borderline product is in fact a medicinal product or not, is expected to change. The MHRA has not published any changes to its guide setting out its policy and practice in determining whether a product is a medicinal product (MHRA Guidance Note 8) since the Court of Appeal decision. It is not known at this stage whether and if so, how, the guidance will be updated. However, the classification of (i) products already on the UK market, (ii) products that will be launched in future, and (iii) products using other ingredients which are sold as food or food supplements but could be viewed as medicinal products due to their functions, could change as a result of the Court of Appeal decision.
- Whilst the Court of Appeal decision concerns GCPs, unrelated products sold as food supplements using active ingredients other than glucosamine which, like GCPs sold as food supplements, are widely used for self-medication, could well be investigated and their classification revisited, especially if there exists a medicinal product sharing the same active ingredient or other significant characteristics with those 'food supplement' products. The details of such characteristics or the level of dosage will inevitably differ depending on the nature and therapeutic effect of the product in question.
- The court's decision could also result in a closer review by the MHRA in considering whether a food supplement satisfies the second 'functional' limb of Article 1.2 of the Medicinal Products Directive (rather than only considering the 'presentational' limb of Article 1.2 as has been the case for GCPs). The fact that certain types of products are currently widely available on the UK market as food supplements rather than as medicines no longer can be relied upon. Instead the correct question to ask is whether a significant proportion of the products in question have been used medicinally, notwithstanding that they have been sold as food supplements.
Divergence of classification within the EU
- The classification of GCPs is currently not consistent across the EU. The change in practice in the UK following the Court of Appeal decision will fuel the divergence so that, for example, a GCP which is currently sold as a food supplement could be classified as a medicinal product in the UK while continuing to be allowed to be sold in the Netherlands as a food supplement. Such divergence is a challenge for those businesses wishing to market the same product in multiple jurisdictions within the EU as there are huge differences in the regulatory requirements depending on whether a product is marketed as food or as a medicine.
- As the regulatory requirements which apply to medicinal products are far more stringent than those relating to food supplements, one can envisage circumstances in which it may not be commercially viable to re-launch a product if a food or food supplement has been re-classified as a medicinal product. New product launches can also take longer and be subject to more scrutiny by the MHRA if presented as a product which 'promotes' or 'supports' certain benefits yet in reality is used as if it were a medicinal product due to its function and physiological effect.