A recent judgment of the European Court of Justice (ECJ) sets out key criteria which will enable European food supplement manufacturers and consumers to distinguish between food and medicinal products.
On 15 January 2009, the ECJ published its long-awaited ruling in the Hecht-Pharma case1 in relation to the definition of a food supplement containing “red rice” presented in capsules. The case is significant for food producers as it provides clarification on those products belonging to the “grey area” between food and medicinal products (‘borderline products’). It also confirms previous rulings of the ECJ on the need to narrowly interpret the definition of a medicinal product in relation to its function. Such a definition which covers products whose pharmacological properties have been scientifically observed and are specifically designed to make a medical diagnosis or to modify physiological functions.
There is a need for clear distinctions between food and medicinal products due mainly to two factors: (i) recent changes in the food market and (ii) the introduction of an EC Regulation on nutrition and health claims. In addition, the latest substantial revision of European legislation on medicinal products has led to considerable confusion and uncertainty, as it has been illustrated in the above mentioned ECJ ruling. As the food market is evolving, the number of foods on the market driven by innovation and consumer demand is growing. Consumers nowadays are offered a variety of foodstuffs on the supermarket shelves intended to provide optimal nutrition and some products even claim to have beneficial effects for health. The EC Regulation on nutrition and health claims2 allows disease risk reduction claims to be displayed on food packaging. This type of claim advertises that the food product in question will reduce the probability of developing a disease by positively influencing one or more risk factors.
However, such a claim does not involve a therapeutic purpose, which is inherent to medicines. According to this Regulation, when a reduction of disease risk claim has been authorised, Member States cannot prohibit its use by classifying the active substance as a medicinal product.
When a product is deemed to be a medicine, marketing authorisation is required before it can be put on the market. Without this authorisation, Member States can prohibit the product from being sold. However, if the product is a food supplement which makes nutritional claims, no such authorisation will be required and the product can be freely marketed, provided it complies with the relevant EC and national legislation.
In this context, the above mentioned judgement shows that, despite the legal definition of a medicinal product and a food product provided by Directive 2001/833 and Regulation 178/20024 respectively, legal certainty and clarity is still required by food producers and the national competent authorities in relation to borderline products. Moreover, existing differences between Member States in the classification of products within one of these categories may hinder trade in the internal market.
The ECJ judgment in the Hecht-Pharma case concerns the classification by the German administrative authorities of a food supplement composed of fermented red rice, which contains monacolin (a substance similar to lovastatin, an inhibitor of cholesterol, which is contained in a number of prescription medicinal products), as a medicinal product.
Hecht-Pharma, which operates a wholesale pharmaceutical business, marketed the food supplement in Germany. The German administration challenged Hecht-Pharma on the grounds that its “Red Rice” food supplement was actually a medicine and therefore could not be legally sold in Germany without a marketing authorisation. The regional court dealing with this action concluded that the legislation on medicinal products applied to the supplement on the grounds that it fell within the definition of a medicine by function.
Hecht-Pharma appealed against the judgment to the German Federal Administrative Court, which in turn referred the question of the interpretation of Directive 2001/83 to the ECJ.
Does the rule of doubt apply if the potential medicinal properties have not been positively determined?
The court emphasised that the purpose of Article 2(2) of Directive 2001/83 is to ensure legal certainty where a product falls under the definition of both a “medicinal product” and also of “other regulated products”. In such circumstances the product must be subject to the provisions of Directive 2001/83. Therefore, an analysis under Article 2(2) starts from the premise that the product concerned satisfies the conditions for classification as a medicinal product.
According to the Advocate General Trstenjak (AG) Opinion, such provision must not be seen as a rule of presumption or a rule of evidence under which a certain degree of probability suffices for the purpose of accepting, in an individual case, that a product has the characteristics of a medicinal product by function5. In contrast, the provision is intended to clarify that Directive 2001/83 should not apply where a product clearly falls under the definition of other product categories different from the “medicinal product” category, in particular those of food and food supplements.
The ECJ concluded in its ruling that the Directive only applies when it has been scientifically established that the concerned product is a medicinal product by function.
Are use, extent of distribution, familiarity to consumers and risk of use still relevant criteria?
The definition of a medicinal product set out in Directive 2001/83 was amended in 2004 by Directive 2004/27. As a result, the definition of a medicinal product was made more precise and now specifies the type of action (pharmacological, immunological or metabolic) which a medicinal product must exert with a view to modifying human physiological functions.
According to the ECJ, the purpose of these amendments was to take into account the emergence of new therapies, as well as the growing number of borderline products. However, according to the ECJ, the amendments were not intended to modify the criteria laid down in EU case-law, according to which, the definition of a medicinal product must take into account all the characteristics of the product, in particular, its composition, its pharmacological properties, the manner of its use, the extent of its distribution and the familiarity to consumers and the risks which its use may entail6.
The Hecht-Pharma case decided that all the characteristics of a product are still relevant to determine whether it is classified as a medicinal product by function.
Can a product be regarded as a functional medicinal product if its composition and intended dosage cannot produce a pharmacological effect?
In the light of the above, products containing any substance having a physiological effect cannot automatically be classified as medicinal products by function.
As the AG pointed out in its Opinion on this case, when national authorities analyse a product they have to verify all the characteristics of the product on a case-by-case basis, also bearing in mind the manner in which it is used. Following the example from a number of ECJ judgments on the classification of vitamins7, the AG stressed that it is not possible to draw scientifically accurate conclusions in relation to a product’s characteristics as a medicinal product without taking into account the respective intended dosage8.
The ECJ concluded in its judgment in the Hecht-Pharma case that, apart from products intended for making a medical diagnosis, a product cannot be defined as a medicine when its composition, including its content in active substances, does not restore or modify physiological functions by exerting a pharmacological, immunological or metabolic action.
Consequences of the judgment
We can assume from the ECJ’s conclusions in this judgment that Germany had wrongly classified the red rice preparation as medicinal product. In particular, the German Administration failed to verify the criteria under Directive 2001/83 to positively conclude that the product in question can indeed be considered a medicine.
Both the ECJ judgment and the AG Opinion confirm specific criteria in relation to the classification of borderline products laid down in settled case law. According to the recent ECJ ruling, pharmaceutical law only applies to those products sold for treatment, cure or prevention of human diseases and to products which, by their composition, are scientifically proven to modify physiological functions.
In conclusion, this judgment of the ECJ improves legal certainty and provides settled criteria to help food supplement producers, national authorities and consumers to draw the line between food products and medicines.