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Court Treads Border Between ‘Medicines’ and Food Supplements

In an important decision for pharmacists and the pharmaceuticals industry, the High Court has helped to define the controversial border between heavily regulated prescription medicines and food supplements that contain the same active ingredients.

Two pharmaceutical companies made and marketed a prescription-only drug, the active ingredient of which was glucosamine, which is used in the treatment of osteoarthritis. The drug, which had obtained marketing authorisation after satisfying exacting tests, faced stiff competition from food supplements which also contained glucosamine but which were available over the counter.

The market for glucosamine-based products was worth up to £60 million a year in the UK. The substance has been a popular food supplement for many years and there were about 800 products containing glucosamine sold in Britain, the vast majority of them marketed as food supplements.

The companies particularly objected that many over-the-counter glucosamine products were dispensed by pharmacists to patients to fulfil doctors’ prescriptions which did not specify a prescription-only drug. That practice was said to cost the producers of prescription-only glucosamine tablets more than £10 million a year.

The companies mounted a judicial review challenge to the refusal of the Medicines and Healthcare Products Regulatory Agency (MHRA) to categorise as ‘medicinal products’ a raft of glucosamine tablets sold as food supplements. They sought an order requiring the MHRA to take enforcement action to block over-the-counter sale of all glucosamine-based food supplements or at least those which recommended a daily dose of 1,500mg.

It was submitted that such products had in the past been marketed as having ‘medicinal’ properties – although there was currently no proof that healthy patients derived any benefit at all from taking them. The risk – if any – of taking food supplements rather than the drug was if anything greater, in that the latter had to comply with more rigorous labelling requirements and was manufactured and distributed subject to higher standards of control.

However, in dismissing the companies’ claim, the Court found that the MHRA had correctly applied a multi-factorial test to the issue. There had been a well-established market for glucosamine-based food supplements – which were said to promote healthy joints – for at least 20 years and it could not be concluded on the evidence that customers in general viewed them as medicinal.

Where promoters of glucosamine-based food supplements made medicinal claims for their products, the evidence was that the MHRA took firm action. It had taken steps against at least 96 companies between 1992 and 2013. The Court also rejected arguments that the MHRA did not carry out case-by-case assessments of food supplements containing glucosamine and that its policy on the issue was fundamentally flawed.