First European Commission Borderline Decision: Does it Answer or Raise Questions?
The European Commission is preparing its first borderline decision under Article 13(1)d of Medical Devices Directive 93/42 (“the Article 13 Decision”). The draft is available here. This provision allows Member States to request that the European Commission decide whether a specific product should be considered a medical device. The draft Article 13 Decision holds that certain cranberry products are not medical devices. But what are they then, and why does this matter? We provide a brief analysis below.
Background of Borderline Issues
Borderline issues arise where the regulatory qualification of a product—for instance as a medicine, a food (supplement) or a medical device—is not clear. One of the key elements for determining the qualification of a product is its primary mode of action. If that is a physical action, for instance, the product may qualify as a medical device. The definitions in the respective pieces of EU legislation are key. The relevant parts in the context of the Article 13 Decision are:
EU Directive 2001/83 on Medicinal Products provides that a product may qualify as a medicinal product when it exerts “a pharmacological, immunological or metabolic action” (emphasis added).
EU Directive 93/42 on Medical Devices defines a medical device as substances, articles or materials “intended by the manufacturer to be used for human beings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of disease, (…) and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means” (emphasis in original).
EU Food Supplements Directive 2002/46/EC provides that “foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect” (emphasis in original), such as capsules, are food supplements.
The qualification as a medicinal product, medical device or food (supplement) has important regulatory consequences, with a direct impact on the marketing of the product. It determines, for example, whether a marketing authorization in accordance with EU medicines legislation is required, whether food additives rules apply, or which (health) claims companies can make regarding their product. The European Commission regularly updates guidance with examples of borderline cases (e.g., Manual on Borderline Decisions, and Meddev Guidance) to help manufacturers in determining the qualification of their products.
Cranberry Products: Treatment for Urinary Tract Infections?
The vast majority of cranberry capsules are marketed as food supplements. Manufacturers may not make health claims regarding these products. Indeed, the EU Nutrition and Health Claims Regulation 1924/2006 (“the NHCR”), which applies to foodstuffs (including food supplements), imposes very strict rules and only allows health claims that are authorized by the European Commission. Cranberry product manufacturers undertook numerous attempts to obtain an authorization for health claims related to cranberry products, but so far, none were accepted by the European Food Safety Authority and the European Commission. Most of the proposed claims related to the alleged beneficial effect cranberry products have been in relation to urinary tract infections (“UTIs”) or more generally to their anti-oxidant properties.
In recent years, some cranberry product manufacturers have positioned their products as medical devices. The companies obtained a CE-mark for their products following an assessment by a notified body in the EU. While health claims for cranberries that qualify as food supplements require formal Commission approval under the NHCR, the medical devices rules are much less strict.
The Article 13 Decision
Certain cranberry products make express reference to their ability to prevent or treat UTIs based on an anti-adhesion effect (physical action) of proanthocyanidins (“PAC”) in cranberries. France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (“ANSM”) asked the European Commission to decide whether these products indeed qualify as medical devices.
Article 13(1)d of the Medical Devices Directive allows Member State authorities to submit a “duly substantiated request” to the European Commission, when they consider “that a decision is required as to whether a particular product or product group” falls within the definition of a medical device. The recent draft Article 13 Decision is the first such decision prepared by the European Commission. At the request of the ANSM, the Commission decided that “the group of products whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry (Vaccinium Macrocarpon), is to prevent or treat cystitis” are not medical devices.
Unfortunately, the Article 13 Decision does not say much more than that. Indeed, its scope is very narrow and its operative part is very short. It merely says that the products are not medical devices and the only explanation is a recital that states that the principle intended action “is achieved by pharmacological, immunological or metabolic means.” This seems to suggest that the Commission is leaning more towards a qualification as a medicinal product than a food supplement. Unfortunately, due to the brevity of the decision, this remains an open question. In our view, the Article 13 Decision leaves many questions unanswered:
Which specific aspects of these products led to the conclusion that they are not medical devices?
Are these aspects relevant to all ingested products containing cranberry extracts?
What is the scientific background for the decision’s recital that the principal intended action of cranberry products depending on PAC present in cranberry is achieved by pharmacological, immunological or metabolic means? Why does the Commission not refer to one of these forms of action?
Does that recital mean that the European Commission considers these cranberry products to be medicinal products? To what extent is that binding?
In the latter case, are these products likely to qualify as (traditional) herbal medicines? At what concentrations?
The Article 13 Decision seems to be a missed opportunity for providing useful clarification. The answers to the last three questions also have significant regulatory implications. If the products are (traditional) herbal medicinal products, manufacturers will need to submit a marketing authorization application under the EU (traditional) herbal medicinal products rules. The dossier requirements are lighter than for “regular” medicinal products but the dynamics of the EU medicines rules are of course completely different from the rules on devices or foods. If the products are not considered medicinal products, they will likely qualify as food supplements. In that case, manufacturers cannot make health claims about the products, as long as these are not approved under the strict NHCR.
The Article 13 Decision still requires approval via the so-called comitology procedure, more specifically the examination procedure. This means that a committee of Member State experts will analyze the decision and could still block it, be it by qualified majority. Reportedly, the European Commission is confident that the decision not be challenged during the examination procedure and expects final adoption by the end of the year. Interested parties could still make submissions. Whether the final decision will indeed put an end to the cranberry discussions or instead simply move the debate from a food-medical devices to a food-medicine borderline issue, remains to be seen.