Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg.

• Jurisdiction: European Union
• Court: Court of Justice (European Union)
• Writing for the Court: Borg Barthet
• ECLI: ECLI:EU:C:2008:352
• Date: 19 June 2008
• Docket Number: C-140/07
• Procedure Type: Reference for a preliminary ruling

OPINION OF ADVOCATE GENERAL

TRSTENJAK

delivered on 19 June 2008 (1)

Case C‑140/07

Hecht-Pharma GmbH

v

Staatliches Gewerbeaufsichtsamt Lüneburg

(Reference for a preliminary ruling from the Bundesverwaltungsgericht (Germany))

(Directive 2001/83/EC, as amended by Directive 2004/27/EC – Pharmaceutical products – Concept of ‘medicinal product by function’ – Rule of doubt in Article 2(2) of Directive 2001/83/EC – Relevant criteria in determining whether a product is a medicinal product – Account to be taken of the intended dosage – Free movement of goods – Public health – Principle of proportionality)

I – Introduction

1. By its reference for a preliminary ruling pursuant to Article 234 EC the Bundesverwaltungsgericht (Federal Administrative Court) has referred three questions to the Court of Justice of the European Communities concerning the interpretation of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. (2)

2. These questions have been raised in proceedings brought by Hecht-Pharma GmbH (‘the appellant’) contesting a decision of the Bezirksregierung Lüneburg (District Administration, Lüneburg, ‘the respondent’) prohibiting Hecht-Pharma from marketing a product, which was actually declared as a food supplement and known as ‘Red Rice’, on the ground that it was a medicinal product that required authorisation but had not been authorised.

3. The question at the centre of the legal dispute in the main proceedings is whether the product in question comes within the definition of a medicinal product and whether the respondent was entitled to proceed on the basis that it required authorisation. Consequently, the Court must here examine the criteria upon which the Member States’ authorities have to base their decision to apply the law on medicinal products and the degree of certainty necessary with regard to the pharmacological action of a product for the purpose of classifying it as a medicinal product.

II – Legal context

A – Community law

4. Under Article 1(2) of Directive 2001/83, the term ‘medicinal product’ referred to:

‘Any substance or combination of substances presented for treating or preventing disease in human beings;

Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings is likewise considered a medicinal product.’

5. Directive 2004/27/EC (3) of the European Parliament and of the Council of 31 March 2004 has now amended this definition. It now reads as follows:

‘(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings, or

(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.’

6. Directive 2004/27 also reformulated Article 2 of Directive 200l/83 and introduced a new Article 2(2). Article 2(2) states:

‘In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a “medicinal product” and within the definition of a product covered by other Community legislation, the provisions of this Directive shall apply.’

B – National law

7. Under Paragraph 69(1) of the German Arzneimittelgesetz (Law on medicinal products, ‘the AMG’), the competent authorities are required to take the necessary steps to eliminate infringements that have been confirmed and to prevent future infringements. They may, in particular, prohibit the placing on the market of medicinal products in, the absence of the necessary authorisation or registration of such products.

III – Facts and main proceedings

8. The appellant in the main proceedings operates a pharmaceutical wholesale business. In October 2002 the Arzneimittelkommission der deutschen Apotheker (Committee for medicinal products of German pharmacists) informed the Bezirksregierung Lüneburg (District Administration, Lüneburg) that the appellant had announced that from 1 September 2002 it would place on the market a product under the name ‘Red Rice 330 mg GPH Kapseln’ containing the active substance monacolin k. That substance is identical with lovastatin, a cholesterol synthesis inhibitor which is marketed in Germany as a prescription medicinal product.

9. The capsules in issue are marketed in plastic bottles with labels stating inter alia: Red Rice, 330 mg, food supplement with fermented rice. It is further stated: ‘One capsule contains 330 mg of red yeast rice corresponding to 1.33 mg of monacolin k’. The ingredients are stated to include 71% red rice powder. The recommendations for use read: ‘As food supplement, 1 capsule 1-3 times daily’.

10. On 4 December 2002 the Bundesinstitut für Arzneimittel und Medizinprodukte (Federal Institute for medicinal products) issued a press release warning against the consumption of red rice products. With the simultaneous taking of red rice and medicinal products to reduce high cholesterol values, an increased risk of side-effects was to be feared; these could take the form in particular of damage to muscle tissue. On application by the Bezirksregierung Lüneburg, the Bundesinstitut stated that the product marketed by the appellant, on the basis of its predominant purpose, was a medicinal product within the meaning of Paragraph 2(1) of the AMG; the substances contained in the product were liable to influence the body or its condition.

11. The Niedersächsisches Landesamt für Verbraucherschutz und Lebensmittelsicherheit (Office for consumer protection and food safety of the Land of Lower Saxony) concluded in a report of 6 December 2002 that classification of the product as a food supplement, and hence as a foodstuff, was not justified. The reference on the packaging drew attention in particular to the ingredient monacolin k, which is not a nutrient but a therapeutically active substance.

12. By decision of 19 December 2002, the Bezirksregierung Lüneburg prohibited the appellant from marketing the product at issue in Germany. As grounds it stated that the product was a medicinal product and had not obtained the requisite authorisation. The appellant’s objection was dismissed by the Bezirksregierung by decision of 11 June 2003.

13. By its application the appellant submitted that classification as a medicinal product is possible only if, on the basis of its dosage and recommended daily consumption, the product produces a pharmacological effect, which must be proved by the authorities, something which did not happen in the present case. The product marketed was, the appellant argued, fully in line with a series of other foodstuffs which also had a positive effect on cholesterol levels, such as margarine (‘Becel’) or salmon-oil capsules. Classification as a medicinal product, by contrast to its classification in Austria as a foodstuff, amounted, in the view of Hecht-Pharma, to an unlawful restriction on trade.

14. The Verwaltungsgericht (Administrative Court) dismissed the action by judgment of 28 April 2005. The appellant’s appeal was dismissed by the Niedersächsisches Oberverwaltungsgericht (Higher Administrative Court of Lower Saxony) by judgment of 23 March 2006. While the product marketed by the appellant, the latter court found, did indeed fall within the currently valid concept of a food, it also satisfied the definition of a medicinal product.

15. That classification was, however, of no legal relevance here, since the precedence of the provisions of the law on medicinal products followed from Paragraph 2(2) of the Lebensmittel- und Futtermittelgesetzbuch (Food and Feedstuffs Code, ‘the LFGB’), in conjunction with Article 2 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety, (4) and Article 1 of Directive 2001/83 on medicinal products for human use, as amended by Directive 2004/27.

16. The product at issue was, the Niedersächsiches Oberverwaltungsgericht found, in all probability to be classified as a medicinal product by function. It contained a significant level of monacolin k. That active substance was synonymous with lovastatin, a well-known inhibitor of cholesterol synthesis. The substance lovastatin was contained as a pharmaceutically active component in a number of prescription medicinal products. Inhibitors of cholesterol synthesis and other medicinal products used to reduce fatty substances in the blood could have serious side-effects on the muscles and kidneys. Risks and interactions of such substances were expressly pointed out in the package leaflets of medicinal products on the market for reducing cholesterol. Depending on dosage, monacolin k inhibited cholesterol production of the liver and thus lowered the cholesterol level of the blood in humans and stabilised fat metabolism. Taking the product at issue was therefore liable to lower high cholesterol values, which are regarded as a risk factor for the heart and the circulation, and so contributed to the fulfilment of a therapeutic purpose. That suggested that the product in question is a medicinal product by function.

17. The appellant could not rely on the fact that a pharmacological effect of the product at issue could be ruled out if the recommended consumption was followed. The recommended consumption led to a daily dose of 1.33 mg to 4 mg of monacolin k. That was indeed low when compared with the daily dose of 10 mg to 80 mg recommended for lovastatin. However, the appellant could not conclude from that that...