The opinion of Advocate General Trstenjak in Case C-140/07, Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg

Background

The definition of a medicinal product has evolved ever since it was first introduced in European legislation in the mid-1960s. It has proved problematic to indicate exactly what can be considered a medicinal product, and especially the distinction between food, food supplements, cosmetics, and medicinal products. Over the years many references have been made to the European Court of Justice (Court) to obtain clarity on the exact scope of the definition.

The consequences of a classification either as food supplement or medicinal product is significant for manufacturers, importers, or wholesalers of these types of products. Dependent on the classification, the product concerned will be subject to the rules for food (supplements) or the rules for medicinal products, the latter of which are considerably stricter. During the last years a number of cases which deal with the distinction between food supplements and medicinal products have come before the Court.

At first, the Court was hesitant to provide additional criteria that would lead to more uniform classifications of these products in the Member States. In other words, it accepted differences in interpretation between Member States. For example, according to the Court, it is acceptable that Vitamin C pills are qualified as food supplements in one Member State and as medicinal products in another, if these pills fall within the definition of medicinal product as laid down in Directive 2001/83/EC. However, it pointed out that if a product has been qualified as a food supplement in one Member State, this should be taken into consideration by the authorities of the other Member State when classifying the product. Furthermore, these authorities have to take all characteristics of the product into consideration, which includes composition, pharmacological properties, the manner of use, the extent of distribution, familiarity to consumers and the risks which use may entail.¹

Notwithstanding its initial disinclination in Commission v Germany, the Court refused to accept the classification of capsules containing garlic powder as medicinal product. In this specific case the package and leaflet did not present a message that could make an averagely well-informed consumer believe that the product would prevent or treat disease. The sole fact that the garlic powder was put in a capsule was not considered sufficient. In parallel with these findings, the Court pointed out that the substance in the capsules – both in form and in indicated daily dosage – could not be distinguished from fresh raw garlic with respect to its pharmacological effect. According to the Court it is not sufficient that the product has properties beneficial to health in general, but it must strictly speaking have the function of treating or preventing disease.² Based on the foregoing presentation and function, the product could not be classified as a medicinal product.

Hecht-Pharma

In case C-140/07, Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg the question comes up as to when physiological properties are to be considered sufficient to qualify a product as medicinal. Hecht-Pharma GmbH is a German pharmaceutical wholesaler which started marketing fermented red rice capsules as food supplements in September 2002.

A capsule contained 330 mg of fermented red rice powder with the active substance Monacolin K, a substance identical to Lovastatin, a statin which is used to lower cholesterol levels. The recommended daily dose of Lovastatin is 20 mg, but it is applied in a range from 10 to 80 mg daily. The label on the plastic bottles in which the capsules are marketed indicates: Red Rice, 330mg, food supplement with fermented rice. It also reads: ‘A capsule consists of 330 mg red fermented rice, which is the equivalent of 1.33 mg Monacolin K.’ The ingredients section lists Red Rice powder 71%. The recommended daily dose as a food supplement is 1 capsule 1-3 times a day.

In December 2002 the local competent authorities prohibited Hecht-Pharma to market the product in Germany on the grounds that it qualified as a medicinal product, for which Hecht-Pharma did not have the appropriate licence. Hecht-Pharma filed a complaint to the local administrative court without success. It appealed to the administrative appeals court claiming that classification as a medicinal product is only possible if the product based on dose and recommended daily intake has a pharmacological effect, for which the authorities have to provide the evidence. Hecht-Pharma also claimed that its product fitted perfectly into a range of foodstuffs which have a positive effect on cholesterol levels such as margarine (“Becel”) and salmon oil capsules. Finally, as its product was qualified as a food supplement in Austria, the German qualification as medicinal product constituted an unjustifiable restriction on intra-Community trade.

The appeals court rejected the appeal on the grounds that even though it complied with the concept of foodstuff, it also seemed to come within the scope of the definition of medicinal product. This was due to the fact that the capsules contained a substantial amount of Monacolin K, the equivalent of Lovastatin – a prescription drug inhibiting the cholesterol synthesis. The fermented red rice posed a potential serious risk if used in combination with Lovastatin. According to the appeals court, Hecht-Pharma could not rely on the absence of a pharmacological effect of the product at the recommended daily dose of 1.33 to 4 mg.

Finally, the appeals court ruled that the rules on medicinal products had to be given priority over other legislation based on the ‘rule of doubt’ laid down in Article 2(2) of Directive 2001/83/EC, since the pharmacological action was not proven with absolute certainty.

After the denial of the appeals court Hecht-Pharma decided to appeal to the federal administrative court, which stayed proceedings and referred three questions to the European Court of Justice:

1.    Does the rule of doubt in Article 2(2) of Directive 2001/83/EC in the version of Directive 2004/27/EC mean that Directive 2001/83/EC applies to a product which could possibly be classified as a medicinal product but whose quality of a medicinal product has not been positively determined? What degree of probability and hence what degree of elucidation of the facts may be required in order to justify the application of Directive 2001/83/EC?

2.    Can a product which is not a presentational medicinal product be regarded as a functional medicinal product within the meaning of Article 1(2) of Directive 2001/83/EC in the version of Directive 2004/27/EC because of a component which can produce physiological changes in a certain dosage but whose dosage in the product to be assessed - if used as intended - is too low for that? Is this question to be allocated to the criterion of 'pharmacological action' or the criterion of 'modifying physiological functions in human beings'?

3.    Are the characteristics of 'the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail' (judgment in Case C-211/03 [2005] ECR I-5141, paragraph 51) stated in the case-law of the Court of Justice to be relevant, in addition to the pharmacological qualities, to classification as a medicinal product still relevant following the new definition of a medicinal product introduced by Directive 2004/27/EC?³

In her subsequent opinion⁴ Advocate General Trstenjak advised the Court how to rule on the questions posed by the German federal administrative court. The Court does not have to follow the Advocate General’s advice, even though in practice it generally does.

With its first question the federal administrative court essentially tries to find out whether the ‘rule of doubt’ applies solely to products that fall under the definition of medicinal product as laid down in Directive 2001/83/EC as amended by Directive 2004/27/EC. The Advocate General is rather firm in her reply to this question. In her view the rule of doubt applies only to those cases where a product is covered by both the definition of food (supplement), cosmetic product, or medical device, and the definition of medicinal product. It would run counter to the established case law of the Court and the intentions of the European legislature that led to the inclusion of the ‘rule of doubt’ in Directive 2001/83/EC. In addition, a too broad interpretation of the rule would lead to an application of the definition of medicinal product that is unscientific and therefore lacks expertise. According to the Advocate General, the classification of medicinal product must take place based on scientific criteria in order to protect free movement of goods on the one hand and public health on the other hand.

The second question deals with the definition of medicinal product by function. The federal administrative court tries to find out whether dose influences the criteria of 'pharmacological action' and 'modifying physiological functions in human beings'. More specifically, it tries to find out whether a product that contains a substance in a dose which may not lead to pharmacological action or modification physiological functions, can nonetheless qualify as a medicinal product by function. Advocate General Trstenjak points out that it is contrary to the established case law of the Court and the proportionality principle for a national authority to qualify a product as medicinal without being able to indicate with certainty from which concentration the product passes the threshold from foodstuff to medicinal product. A different interpretation of the applicable rules would lead to the unfavourable situation that a competent authority would be freed from examining the pharmacological action on a case to case basis. The Advocate General observes subsequently that dose influences not only the criterion of criteria 'pharmacological action', but also the criterion of 'modifying physiological functions in human beings'.

In her answer to the third question the Advocate General confirms that the established case law concerning the qualification of medicinal product remains relevant and applicable after the adoption of Directive 2004/27/EC. Therefore, the manner in which a product is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail remain criteria which should be used to find out if products may be classified as medicinal.

Conclusion

We will have to wait and see if the Court will follow the opinion of the Advocate General in this particular case and set another small step to clarify the distinction between medicinal products and food supplements. Considering the Court’s previous hesitation to provide additional guidance on the exact criteria for classification, it will be most interesting to see whether it will follow the strong approach that the Advocate General displayed in her answer to the second question of the federal administrative court. Such an approach would emphasize an obligation for national authorities to motivate a classification as medicinal product along clearly defined lines. This will undoubtedly improve legal certainty.

In this context it seems suitable to finish with an observation of Advocate General Trstenjak as cited by the Court in Commission v Germany:

“As the Advocate General observed, in point 60 of her Opinion, there are many products generally recognised as foodstuffs which may also serve therapeutic purposes. That fact is not sufficient however to confer on them the status of medicinal product within the meaning of Directive 2001/83.”⁵

Johan Hulshof
Van Benthem & Keulen Advocaten