The regulatory regime that a product falls under may have significant impact in terms of compliance and route to market. This issue was recently highlighted in the decision of the Court of Appeal in England and Wales in the case of R (Blue Bio) v Secretary of State for Health (acting for the Medicines and Healthcare products Regulatory Authority) (“Blue Bio”).
Blue Bio related to the classification of a particular glucosamine containing product used in the treatment of osteoarthritis and, in particular, whether this product constituted a ‘medicinal product’ or a ‘food supplement’, both of which have separate and distinct regulatory regimes.
In the context of the appeal, Blue Bio sought to challenge the classification of the product as a medicinal product for the purposes of Directive 2001/83/EC and, as such, was regulated by the Medicines and Healthcare products Regulatory Authority (“MHRA”) on the basis that it contained the ingredient glucosamine.
In this regard, Blue Bio argued that there were several other products containing glucosamine which had not been classified as such and therefore were subject to a much less stringent and exacting regulatory regime. Further, it argued that by classifying the product as a medicinal product, the company was required to obtain marketing authorisation prior to going to market, a requirement that does not apply to food supplements.
In upholding the appeal, the Court of Appeal indicated that the MHRA should give due consideration to products which straddle multiple regulatory regimes and the consequent manner in which they are classified.