The recent 2016 case of R (Blue Bio) v Secretary of State for Health (acting for the Medicines & Healthcare products Regulatory Agency (“MHRA”) [2016] EWCA Civ 554 highlights the challenges of determining what regulatory regime applies to products.

The focus in the Blue Bio case was whether or not the product was a food supplement or a medicinal product.

Blue Bio

The claimant sought to challenge the MHRA’s decision to classify its product as a medicinal product regulated under Directive 2001/83/EC. The product in question, Dolenio, contains glucosamine which is also marketed as a food supplement. The claimant challenged the fact that the MHRA had failed to classify other glucosamine containing products (“GCPs”) as “medicinal products” where the pharmacological composition, method of ingestion and effects were the same. This approach allowed competitors to market identical products under a much less stringent regulatory regime. By contrast, if a product is a “medicinal product” it requires a marketing authorisation before it can be placed on the European market.

Blue Bio sought a declaration that all GCPs were medicinal products or that those GCPs with a recommended dose of 1500mg are medicinal products.

The Court of Appeal upheld Blue Bio’s challenge. It held that the MHRA should reconsider its approach and review the position for GCPs that share several characteristics with Dolenio.

Borderline products

Setting aside the commercial implications of the Blue Bio decision on the glucosamine sector, the case serves as a reminder of the importance of assessing the regimes in which your product may or may not fall.

Examples that affect many clients are the interaction of the regimes covering:

  • Enteral feeds/substances and food legislation;
  • Cosmetic products and Biocidal Products, REACH, the Toys Directive and pharmaceutical products;
  • Medicinal products and medical devices; and
  • Electronic cigarettes and medicinal products and products regulated under the Tobacco Directive.

A complicating factor is that a product can have a different status between European member states. European case law, for example, confirms that what one member state could classify (and regulate) as a medicinal product, another could classify as a medical device. The implications for this is that it may introduce compliance requirements with other product regimes. For example, if a product is classified as a medical device, the EU RoHS regime will then need to be considered.

Often, a legal and technical assessment is needed in relation to the function of the product, how it is presented and what claims are made in relation to it.

The impact of the classification will then also feed into the safety, labelling and compliance obligations which may well be contained in wider environmental and regulatory legislation. It is therefore important for both a technical and legal assessment to be undertaken to ensure compliance obligations are met.