On 22 February 2016, the European Commission released a draft version of its first borderline decision under Article 13(1)(d) of the Medical Device Directive. Since the judgment in Laboratoires Lyocentre (Case C-109/12), it has been confirmed that EU legislation does not prevent a single product from being classified differently by different Member States. The procedure provided for by Article 13(1)(d) of the Medical Device Directive may be the only way to resolve the impasse left by the Lyocentre case by creating the means to harmonise the classification of medical device by the back door. However, whether this approach is welcome by industry remains to be seen in light of its limitations and associated burden.
The European Commission’s decision in this instance related to cranberry products whose principal intended action, based on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis (hereafter referred to as “the Product”).
The request to the European Commission to determine the classification of these products was triggered by diverging classifications of the Product throughout the EU. The request was made by the French National Agency of Medicines and Health Products (Agence Nationale de Securitie du Medicament et des Produits de Sante) (ANSM) and was prompted by its own assessment that Arkopharma’s product “cys-control” did not qualify as a medical device. “Cys-control” is a cranberry based product which comes in sachet or capsule form and it was previously classified in France as a Class IIb Medical Device. The negative assessment by ANSM resulted in Arkopharma being required to change the status of “cys-control” back to a food supplement in March 2014.
The legal basis for the request by France derives from Article 13(1)(d) of the Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993) which allows the European Commission to take a decision upon request from a Member State, on whether a product or product groups fall within a definition of a “medical device” from Article 1(2)(d) of the Medical Device Directive. Article 13 (1)(d) is, however, limited in scope. The European Commission does not have the power to determine the classification of the product in the event that they determine that the product in question falls outside of the scope of the definition of a medical device. For example, if they determine that a product is not a medical device, they cannot go one step further and determine whether the product is a medicinal product or a food supplement.
A medical device is defined in the Medical Device Directive as “any instrument, apparatus, appliance, software, material or other article (…) 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”.
In order to determine whether a product will legally qualify as a medical device it is necessary to consider the following points:
• The intended purpose of the product taking into account the way the product is present; and
• The method by which the principal intended action is achieved.
For a medical device, the principal intended action is typically fulfilled by physical means (including a physical barrier or a mechanical action). Therefore, the types of claims made for a product, in accordance with its method of action, represent an important factor when looking at the classification of the product.
The draft decision of the Commission states that the principal intended action of the Product at issue is to treat cystitis by inhibiting adhesion between p-fimbriated E.Coli and mucous membrane cells in the urinary tract. Therefore, the Commission found that such action achieves its principal intended action in or on the human body “by pharmacological, immunological or metabolic means” and that therefore, the Product falls outside of the definition of medical devices. The fact that the Commission found that the intended action was achieved “by pharmacological, immunological or metabolic means” does raise the question of whether the Commission was hinting that the Product should be classified as a medicinal product (or potentially a food supplement).
In this regard, the vast majority of cranberry capsules are marketed as food supplements. Very strict rules apply in relation to the claims that can be made in relation to food supplements. The EU Nutrition and Health Claims Regulation 1924/2006 takes a strict approach to health claims within food products and only permits health claims that are pre-authorised by the European Commission. Cranberry product manufacturers have undertaken numerous attempts to obtain an authorisation for health claims relating to cranberry products, but so far, none have been 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 in relation to urinary tract infections or more generally to their anti-oxidant properties.
For completeness, it is worth remembering the so-called “garlic case” (Commission v Germany Case C – 319/05), which involved the classification of garlic capsules. The judgment in the “garlic case” made clear that the key element, in order for a product to be classified as a medicinal product; its function must “significantly affect” metabolism. It was held in the “garlic case” that if the effect on physiological functions “is no more than the effect which a foodstuff consumed in a reasonable quantity may have on those functions” then it is not a medicinal product. Therefore, substances that do not have a significant physiological effect on the body and so do not, strictly speaking, modify the way in which it functions, cannot be considered as medicinal products.
It is unfortunate that the Commission decision is rather short and does not provide the details of the analysis conducted by the Commission in its determination on the classification of the Product. For example, it does not address which specific aspects of the Product led to this conclusion and therefore it is unclear how far reaching the scope of this decision may be in relation to all ingested cranberry products.
However, this is probably due to the scope of the power conferred to the European Commission. On one hand, the limitation in the scope of their power is understandable, as to extend the scope would take away decision-making power from Member State’s regulatory bodies. On the other hand, this is an undesirable lacuna as it means that Member States who require guidance on whether a product qualifies as a medical device will have to go through a very burdensome process which will lead to extensive delays in placing the product on the EU market, as there would still be uncertainty as to the classification of a product if it is not a medical device.
The Commission’s draft decision is certainly not ideal for cranberry marketers. While cranberry products sold as food supplements remain on the market, as noted above, the European Food Safety Authority and the European Commission have rejected various health claims for cranberries. Therefore, manufacturers now have their hands strictly tied in relation to what they can and cannot say about cranberry products.
The EU’s 28 Member States have been asked to comment on the draft decision, following which, the draft Decision will be forwarded to the European Parliament and the Council of the European Union for review. Following the same, the draft Decision will then be adopted, amended or withdrawn by the European Commission. If adopted, the draft Decision will enter into force on the 20th day following its publication in the Official Journal of the European Union. It is currently unknown as to whether any Member States will be sufficiently disgruntled to appeal the decision, if implemented, to the General Court.
It will be interesting to see whether this decision will prompt further referrals to the European Commission to consider borderline medical device issues. It also remains to be seen how industries will react to the use by Member States of this ‘dormant’ procedure to resolve conflicts on the classification of borderline products. On one hand, it leads to the harmonisation of a specific product which is then freely commercialised under one single regulatory framework. But on the other hand, this procedure lays an additional burdensome process to overcome before borderline products can be placed on the EU market and therefore causes unavoidable delays.