The Administrative Court of the U.K. High Court of Justice, Queen’s Bench Division, has determined that the Medicines and Healthcare Products Regulatory Agency (MHRA ) has acted appropriately in denying the request of drug makers to classify all glucosamine-containing products (GCPs) as medicines under the Medicines Directive. Blue Bio Pharms. LTD v. MHRA, No.  EWHC 1679 (Admin., decided May 22, 2014).
The court also denied the drug makers’ request that all GCPs with a daily recommended dose of 1500 mg be declared medicines, MHRA ’s decision not to take enforcement action against all such GCPs be quashed and MHRA ’s policy “of failing to conduct any case by case analysis as to whether unauthorized GCPs fall within the functional limb of the definition of medicinal products” be declared unlawful.
According to the court, unauthorized GCPs have been sold as food supplements throughout the United Kingdom and Europe for many years and currently account for some one-fifth of all sales of GCPs dispensed by pharmacists in response to GCP prescriptions. The drug makers, whose GCP products are regulated as medicines with MHRA ’s approval, first brought the unauthorized GCP issue to MHRA ’s attention in 2010; the agency thereafter noted that it had taken action against 186 products that made medicinal claims, but refused to take action against other unauthorized GCPs that did not make medicinal claims. Approached by the drug makers again in 2012, MHRA issued a “decision letter” in March 2013 rejecting the claim that all GCPs with the same active ingredient and dosage as their drug are necessarily medicines or that MHRA had acted illogically or unlawfully. According to MHRA , “our powers do not extend to requiring non-medicinal products to be labelled with statements that they are non-effective or that they are not medicines.” MHRA also emphasized that any individual product considered to be a medicinal product “will be subjected to appropriate and proportionate regulatory action.”
Examining the relevant medicines and food law requirements, the court determined that MHRA had acted appropriately because it was required to determine whether a product falls within the medicines definition on a case-by-case basis and “cannot apply a ‘general rule . . . applicable without distinction’ or ‘applied systematically to all products.’” Among other matters, the court noted that “the purpose for which a product is used and/ or marketed (‘the manner in which it is used’) is often a critical factor in distinguishing between medicinal and non-medicinal products.” If a GCP product is sold as a “food supplement” and does not claim to prevent, treat or cure a human disease, it cannot be regulated as a medicine, in the court’s view. It further noted that all relevant characteristics must be considered in “borderline” cases, and MHRA is best positioned to apply the appropriate multi-factorial test in each case based on “a mixture of factual and scientific considerations.”
The Health Food Manufacturer’s Association (HFMA ) executive director said, “We are very pleased with the outcome of this highly significant case, which had a very real capacity to have a profound impact on the future for our members, this industry and, perhaps most significantly, consumer choice. We have argued vigorously throughout the case that the current food supplement status for glucosamine should be maintained.” See HFMA Statement, May 20, 2014.