A recent decision of the European Court of Justice (ECJ) is likely to lead to a relaxation of the policy of European medicines licensing agencies to borderline products, saving companies valuable market lead time and costs.
The decision should minimise the fragmentation of product markets across Europe, reducing the number of cases where products are classified as medicines in some member states, but food supplements or cosmeceuticals in others.
Red rice – food or drug?
The product at issue in this case was a fermented red rice food supplement. It was known that the product contained low levels of a type of statin (a pharmaceutically-active cholesterol lowering substance) that was a known and approved medicine, available by prescription.
Such products are often known by the legal/regulatory classification "borderline" products, and can be difficult to distinguish from products that require marketing authorisations as medicines.
In Austria, the product was marketed as a food supplement (and so did not require authorisation as a medicine). However, the German medicines agency decided the product was a medicine and needed to be authorised as such before it could be marketed in Germany.
The producer, Hecht, challenged this decision and the ECJ was asked to give guidance on when the European medicines legislation (Directive 2001/83/EC as amended) applies to such borderline products.
One of the arguments put forward by Hecht was that the product marketed was equivalent to a series of other foodstuffs that also had a positive effect on cholesterol levels, such as certain margarines, or omega-3 capsules.
Hecht also argued that the intended dosage and recommended daily consumption were important factors that needed to be taken into account.
The ECJ decided that, there being an absence of any medicinal claims in the product literature, the medicines legislation should not apply unless it had been scientifically established the product could exert a metabolic, pharmacological or immunological effect.
The Court said all aspects of the product needed to be taken into account when the relevant authority assessed the product, including a consideration of whether or not the dose of any active substance present would result in "appreciable effect" if the product was used as the manufacturer intended.
The Court dismissed the argument that food supplements tended to be taken in higher doses than those recommended and equated this product with a low-dose vitamin preparation, despite evidence of the harmful side-effects.
The approval process for a medicine is both time-consuming and costly. The ECJ considered whether regard had to be given to the burden of compliance with this regime when assessing whether sufficient evidence established that a product acted as a medicine.
It also considered it relevant that inconsistent application of the medicines legislation between member states would affect the free movement of goods between Member States – one of the key aims of the harmonisation of medicines legislation in Europe.
A better deal for food supplements?
In the UK, the Medicines and Healthcare products Regulatory Agency’s (MHRA) approach to such products has, up to now, been very much based on the previous case law of the ECJ (for example, Upjohn, C-112/89) and is a precautionary one.
If a product is either presented as a medicinal product, or acts as a medicinal product, then the MHRA would typically require the manufacturer to apply for a licence to market the product in question as a medicine.
The ECJ has now arguably placed the burden of proof (in UK cases at least) on the MHRA to establish the functional limb of this test to a high degree of certainty and gives the benefit of any doubt to the company seeking to market the product.
This decision is likely to be welcomed by manufacturers of "enhanced" foods and food supplements as it should require European medicines licensing authorities, including the MHRA, to scientifically establish that a product can act as a medicine before they can require companies to comply with European medicines legislation.
The case will now go back to the German Appeal Court who will have to decide if the German Medicines Agency did, in fact, scientifically establish that the product in issue could act as a medicinal product.
The verdict can be found here.
Gareth Morgan is a partner in Taylor Wessing's intellectual property department. He has experience in intellectual property law with a particular focus in the life sciences and healthcare sector, and also advises on medicinal regulatory law.