Commission of the European Communities v Federal Republic of Germany.

• Jurisdiction: European Union
• Celex Number: 62005CC0319
• ECLI: ECLI:EU:C:2007:364
• Court: Court of Justice (European Union)
• Date: 21 June 2007
• Procedure Type: Recurso por incumplimiento – fundado
• Docket Number: C-319/05

OPINION OF ADVOCATE GENERAL

TRSTENJAK

delivered on 21 June 2007 ¹(1)

Case C‑319/05

Commission of the European Communities

v

Federal Republic of Germany

(Failure of a Member State to fulfil obligations – Article 226 EC – Free movement of goods – Measures having equivalent effect – Directive 2001/83/EC – Meaning of the term ‘medicinal product’ – National administrative practice according to which a garlic preparation in capsule form is classified as a medicinal product)

I – Introduction

1. The present case is based on an action for failure to fulfil obligations brought by the Commission pursuant to Article 226 EC against the Federal Republic of Germany, by which it asks the Court of Justice to declare that by classifying as a medicinal product a garlic preparation in capsule form which does not fall under the definition of a medicinal product by presentation under Article 1(2) 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) the Federal Republic of Germany has failed to fulfil its obligations under Articles 28 and 30 EC.

2. The dispute thus hinges on whether the garlic preparation in question falls under that definition or whether it is to be regarded as a food supplement within the meaning of Article 2(a) of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. (3)

II – Legal framework

1. Primary Community law

3. Article 28 EC prohibits quantitative restrictions on imports between Member States and all measures having equivalent effect.

4. Under Article 30 EC, prohibitions or restrictions on imports are permitted where they are justified on grounds of public security and the protection of health and life of humans, provided they neither constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.

2. Directive 2001/83/EC

5. Recitals 2 to 5 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 state:

‘(2) The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.

(3) However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.

(4) Trade in medicinal products within the Community is hindered by disparities between certain national provisions, in particular between provisions relating to medicinal products (excluding substances or combinations of substances which are foods, animal feeding-stuffs or toilet preparations), and such disparities directly affect the functioning of the internal market.

(5) Such hindrances must accordingly be removed; whereas this entails approximation of the relevant provisions.’

6. Under Article 1(2) of Directive 2001/83/EC, medicinal products means:

‘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.’

7. Article 6(1) of that directive provides:

‘No medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EEC) No 2309/93.’

3. Directive 2002/46/EC

8. Under Article 2(a) of Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, food supplements are:

‘foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities’.

III – Pre-litigation procedure

9. The Commission took action following a complaint lodged by an undertaking whose application pursuant to Paragraph 47a of the Law on foodstuffs and consumer products (Lebensmittel- und Bedarfsgegenständegesetz; the ‘LMBG’) for the adoption of a decision of general application on the importation and marketing of a garlic preparation in capsule form was refused by the Federal Ministry of Health on the ground that the product was not a foodstuff, but a medicinal product.

10. The product in question is marketed under the designation ‘Knoblauch-Extrakt-Pulver-Kapsel’ (‘garlic extract powder capsule’) or ‘Knoblauch-Zwiebel-Pulver’ (‘garlic bulb powder’). According to the information available to the Court, it is an extract obtained using ethanol, which is cultivated on a medium (lactose) for the technological purpose of spray drying. The product is composed of carbohydrates, proteins and fats, as well as trace elements and vitamins.

11. After a lengthy informal exchange, on 24 July 2001 the Commission sent a letter of formal notice to the Federal Republic of Germany in which it concluded that the classification of garlic bulb powder in capsule form as a medicinal product on grounds such as those chosen in the case of the complaint is incompatible with the principles of the free movement of goods under Article 28 EC and Article 30 EC and the relevant case-law. The German Government replied to the letter of formal notice on 5 October 2001.

12. In its reasoned opinion of 19 December 2002, the Commission called on the Federal Republic of Germany to put an end to the administrative practice according to which products which consist of dried powdered garlic and which are clearly not labelled or presented as medicinal products are treated as medicinal products.

13. The Federal Government replied by letter of 14 March 2003. It reported that the classification of the product in question as a medicinal product had been re-examined and had to be maintained.

IV – Proceedings before the Court of Justice and forms of order sought by the parties

14. In its application, which was lodged at the Court Registry on 19 August 2005, the Commission claims that the Court should declare that by classifying as a medicinal product a garlic preparation in capsule form which does not fall under the definition of a medicinal product by presentation under Article 1(2) of Directive 2001/83, the Federal Republic of Germany has failed to fulfil its obligations under Articles 28 and 30 EC. It also claims that the Court should order the Federal Republic of Germany to pay the costs.

15. In its defence, lodged on 11 November 2005, the German Government claims that the Court should dismiss the action as unfounded and order the Commission to pay the costs.

16. The written phase of the proceedings concluded following submission of the reply on 3 February 2006 and the rejoinder on 7 April 2006.

17. At the hearing, held on 19 April 2007, the representatives of the Commission and of the Federal Republic of Germany confirmed their respective positions.

V – Submissions of the parties

18. The Commission points out, first of all, that, in addition to protecting human health, the Community rules on medicinal products are intended to safeguard free movement of goods, with the result that the interpretation of the rules contained in the directive in general and of the term ‘medicinal product’ in particular cannot result in obstacles to the free movement of goods which are entirely disproportionate to the pursued aim of protecting health.

19. As regards the question of classification as a medicinal product by function, in addition to the pharmacological effects of the product in question, consideration must also be given to the methods for use, the extent of dissemination, awareness among consumers and the risks that might be associated with usage.

20. With regard to pharmacological effects, the Commission does not dispute that the product in question may serve to prevent arteriosclerosis, although the same effect could be achieved simply by taking four grams of raw garlic each day. If a product which is claimed to be a medicinal product does nothing more than a conventional foodstuff, this shows that its pharmacological properties are not sufficient for it to be accepted as a medicinal product. According to the Commission, a product that has no further effects does not go far enough to be a medicinal product by function.

21. The product could at most be a food supplement within the meaning of Article 2(a) of Directive 2002/46, that is to say a foodstuff which contains substances with a nutritional or physiological effect, alone or in combination, marketed in dose form. Nevertheless, the attempt to deny that the products in question are foodstuffs certainly does not justify their classification as medicinal products.

22. With regard to the classification of a product as a medicinal product by presentation, this question must be clarified on a case-by-case basis, having regard to the specific characteristics of the product. A product may be regarded as a medicinal product by presentation if its form and the manner in which it is packaged render it sufficiently similar to a medicinal product and, in particular, if on its packing and the information provided with it reference is made to research by pharmaceutical laboratories or to methods or...