The new year has already given rise to a new decision of the European Court of Justice (ECJ) in the case of Hecht-Pharma¹,  the background to which was covered in the September issue of ECHAMP News. The Bundesverwaltungsgericht (German Federal Administrative Court) asked the ECJ to provide guidance on the interpretation of the definition of medicinal product by function as laid down in article 1(2) of Directive 2001/83/EC. ²

Hecht-Pharma reveals yet again the continuing troubles that national authorities and courts have with differentiating medicinal products from closely related products such as food supplements, medical devices, and cosmetics. More importantly however, it also provides guidance in order to sharpen the dividing line between medicinal and closely related products. This case further harmonises the application of pharmaceutical law in Europe.

Introduction of the case

Hecht-Pharma follows the case of Commission v Germany³ in which garlic capsules were qualified as medicinal products by the German authorities to the dismay of the European Commission. In that case the Court held that the garlic content (the equivalent of 7.4 gram of garlic per capsule) in combination with the fact that the product was presented in the form of a capsule did not suffice the qualification of medicinal product.

Facts

The facts of this case differ in a number of ways from Commission v Germany. Firstly, Hecht-Pharma GmbH marketed fermented red rice capsules as food supplements. The content of the capsules – the fermented red rice – is not used as a food and is therefore more distant to the concept of food than the garlic capsules were. Secondly, the active principle that is available in the fermented red rice – Monacolin K – is bioequivalent to a substance called Lovastatin, which has been authorised as a prescription medicinal product indicated for lowering cholesterol levels. Lovastatin is applied in a daily dosage ranging from 10 to 80 mg. The recommended daily dosage of Monacolin K varied from 1.33 to 3.99 mg.

Notwithstanding these specific differences with the case Commission v Germany, the ECJ reasoned from a comparable perspective, therewith clarifying the scope of the definition of medicinal product by function.

The Bundesverwaltungsgericht posed three preliminary questions to the ECJ which can essentially be summarised as follows:

1. Is Directive 2001/83/EC applicable to products of which it is not clear that they are medicinal products by function, but where the possibility of such a classification cannot be excluded? If so, how high should the probability that those products are medicinal by function be to justify application of the Directive?

2. Are the criteria 1) the characteristics of the product, 2) the manner in which a product is used, 3) the extent of its distribution, 4) its familiarity to consumers and 5) the risks which its use may entail, still applicable for the classification of a medicinal product by function after the amendments to the definition of medicinal product by Directive 2004/27/EC?

3. May a product be classified as a medicinal product by function if it is incapable of restoring, correcting or modifying physiological functions on the basis of its composition and use according to indicated dose?

ECJ Decision

In its decision published on 15 January 2009 the ECJ gave the following interpretation of the applicable law.

In its answer to the first question the ECJ considered that Directive 2001/83/EC is limited to industrially-produced medicinal products and excludes products not covered by the definitions of medicinal product as laid down in Article 1(2) of said Directive. The ‘rule of doubt’ provided for in Article 2(2) of Directive 2001/83/EC⁴ applies only to products which satisfy the conditions⁵ for classification as a medicinal product.

The ECJ also observed that the definition of medicinal product by function seeks to cover products with scientifically observable pharmacological properties which are ‘genuinely designed to (…) restore, correct or modify physiological functions’⁶. Hence, a product of which it cannot be scientifically established that it can restore, correct or modify physiological functions by means of pharmacological, immunological or metabolic action cannot be considered a medicinal product by function.

Nevertheless the ECJ considered that this does not rule out the possibility of differences of interpretation and classification of products between the different Member States. Consequently, it is possible that a product is classified as a food supplement in one Member State, whereas it is considered a medicinal product in another.

With respect to the role of the amendments to the definition of medicinal product by function brought about by Directive 2004/27/EC the ECJ is clear. These amendments were adopted with the view to cope with the introduction of new therapies and of the growing number of what the ECJ refers to as ‘borderline’ products.

In addition, the ECJ speculates a little. The Community legislature may have felt a need to make the definition more accurate. According to the ECJ the concept of physiological effect is not exclusively applicable to medicinal products. It is also used for the definition of food supplements. The inclusion of the requirements ‘immunological or metabolic action’, in addition to pharmacological properties makes the distinction between a food supplement and a medicinal product by function more apparent.

Finally the ECJ observes that by no means an intention to modify the criteria laid down in its case law can be derived from the wording of Directive 2004/27/EC. Instead Article 2(2) of Directive 2001/83/EC,⁷ according to the ECJ , confirms its established case law through the inclusion of the requirement to look at all characteristics of a product – a requirement developed by the ECJ.⁸

But if all characteristics of a product should be taken into account for the classification of medicinal product by function, how should the ‘physiological effect’ of a product then be evaluated? Should a product be classified as a medicinal product by function even if it is incapable of restoring, correcting or modifying physiological functions on the basis of its composition and use according to indicated dose, or are the requirements more stringent?
According to the ECJ: “(…) products containing a substance having a physiological effect cannot automatically be classified as medicinal products by function (…)”.⁹  Every product should be carefully examined on an individual basis by the competent authority. This authority should particularly assess the precise pharmacological, immunological or metabolic characteristics of the product in so far as these can be established by current scientific knowledge. But even if such effects are acknowledged for a substance, this does not necessarily lead to the conclusion that a product containing that substance is medicinal by function. The mere fact that pharmacological, immunological or metabolic characteristics can be established should in the words of the ECJ: ‘not lead to the classification as medicinal products by function of products which, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions’.¹⁰

Therefore, a product used in line with the prescribed dose is not a medicinal product by function, if according to its composition, it is unable to appreciably restore, correct or modify the physiological functions in humans.

Consequences

In my view the Hecht-Pharma case is a valuable addition to the established case law of the ECJ with respect to the definition of medicinal product by function. Although the definite classification of a product will factually depend on the evaluation by the competent national authorities, and even though the classifications may differ from one Member State to another, the dividing line between a medicinal product by function and food supplements, medical devices, cosmetics, and other closely related products may just have become somewhat more evident. Especially the clear statement by the Court that the presence of a physiological effect in a substance does not automatically render a product a medicinal product by function, may lead to a more harmonised approach in the EU as to the classification of medicinal products. In addition, the Court forces state authorities to apply a scientific approach in their classification effort of the specific pharmacological, immunological or metabolic mechanisms. If these cannot be clearly established a product may not be classified as a medicinal product by function and consequently fall outside the scope of Directive 2001/83/EC.

Illustrative in this regard is a case decided by the Dutch Court of Appeal in interim injunction proceedings of 23 September 2008,¹¹ which anticipated the ECJ’s decision. A key question in this case was whether a product containing the substance Macrogol – a substance used as laxative – could be considered a medicinal product by function. The product was marketed as a medical device, but a competitor – having obtained a marketing authorization for a product containing exactly the same (active) principles – opposed the sale of the medical device. With reference to the opinion of AG Trstenjak in the Hecht-Pharma case, the Court of Appeal observed that it should be scientifically established that the given substance had a pharmacological or metabolic effect. Since there was doubt with respect to this effect, the Court of Appeal decided it could not qualify a product containing Macrogol as a medicinal product by function in the interim proceedings.

This case reveals that even within one Member State different scenarios for products that are each other’s equals in terms of composition are feasible. In fact, the difference in classification of the products may not be based on the definition of medicinal product by function, but the definition of medicinal product by presentation. There may consequently be room with respect to certain products for manufacturers and wholesalers to align their product’s classification to the most beneficial and economically promising rules.

Johan Hulshof
Van Benthem & Keulen, Advocaten en Notariaat