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 substances developed by medical practitioners or even to testimonials from medical practitioners commending the qualities of the product in question. A statement that a product is not a medicinal product is persuasive evidence, but it is not in itself conclusive.
23. In the present case, the product is not presented or recommended for treating or preventing disease either on the label, on the information printed on the packaging, or in any other way. The external packaging of the product cannot be regarded as typical of medicinal products. The capsule form is the only specific characteristic of the product that relates to medicinal products. However, this external form alone cannot be a decisive indicator. In other respects too, there is nothing in the present case to suggest that the product is a medicinal product by presentation. Consumers know exactly what is contained in the capsules, namely garlic, which they know as a foodstuff. They can also see that the product does not make reference to any therapeutic effect.
24. Lastly, whilst Member States cannot be prevented, in their national law, from making a product which is not a medicinal product within the meaning of Directive 2001/83 subject to the rules applying to medicinal products, the measures to safeguard public health must be proportionate. In the present case, however, the German authorities have not shown that the prohibition on marketing the product in question as a food supplement and the obligation to obtain a marketing authorisation for medicinal products are actually necessary for the protection of the health of the population.
25. The German Government claims that Community law provides that the regime governing medicinal products takes priority over the provisions on foodstuffs and food supplements. According to the case-law of the Court of Justice, the priority accorded to the regime governing medicinal products follows from Article 2, third paragraph, (d) of Regulation No 178/2002 and from Article 1(2) of Directive 2002/46, which both exempt medicinal products from the scope of the rules on foodstuffs and on food supplements. (4) That interpretation is confirmed by Directive 2004/27/EC, by which a revised Article 2 was inserted into Directive 2001/83, under paragraph 2 of which, in cases of doubt, where a product is also covered by other Community legislation – such as the rules governing foodstuffs – the provisions of the directive on medicinal products apply.
26. It then takes the view that the garlic preparation in question is a medicinal product by function, primarily because it has pharmacological properties to which considerable importance is attached. The product in the present case has therapeutic effects which prevent pathological changes in the human body and in particular prevent arteriosclerosis. In support of its view, the German Government relies on various reports and scientific articles.
27. With regard to the Commission’s argument that the effects of the preparation on arteriosclerosis are limited, the Federal Government states that neither the directive on medicinal products nor the case-law of the Court of Justice indicates a ‘materiality threshold’ beyond which a specific level of pharmacological effects has to be proven. If, then, the pharmacological effectiveness is taken to exist, it is irrelevant whether there is a slight or material reduction in the risk of arteriosclerosis.
28. Classification as a medicinal product cannot depend on the origin of the substances and the Court has ruled that in certain large doses vitamins may be classified as medicinal products. (5) The fact that vitamins also occur in many foodstuffs thus does not prevent their classification as medicinal products. The same must apply to garlic and to allicin, the active substance contained in it. It is therefore ultimately irrelevant whether or not an active substance with pharmacological properties also occurs in a foodstuff.
29. The preparation at issue also has pharmacological properties because it could cause health risks if taken. The fact that the consumption of certain other foodstuffs may also have negative effects on health nevertheless cannot call into question their status as medicinal products. Above all, however, the pharmacological and therapeutic effects play a crucial role.
30. With regard to the methods for use, the German Government claims that the fact that the product in question is offered for sale in capsule form essentially suggests that it is a functional medicinal product. The Federal Government states that 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. In the present case the capsule form used suggests that it is intended to be marketed as a medicinal product even if the external form alone cannot be a decisive indicator for classification as a medicinal product.
31. Furthermore, there are numerous medicinal products with active substances such as garlic bulb powder on the market in Germany which are packaged in exactly the same way as the preparation at issue in the main proceedings. The fact that they are all classified as medicinal products suggests that, according to the established view and consumer expectations, the comparable product at issue is also a medicinal product by presentation.
32. The German Government also infers from the Court’s case-law that in deciding on the classification of the product the national authorities have a broad discretion. (6) The Commission has not satisfied the burden of proof on it and cannot show that the exercise of discretion by the German authority, according to which the preparation is to be classified as a medicinal product, has been defective.
33. In the alternative, the Federal Republic of Germany claims, in the event that the Court takes the view that free movement of goods is applicable and considers the classification decision to be a restriction, that the decision was justified in order to protect an overriding public interest, namely to safeguard public health.
VI – Legal assessment
1. Introductory remarks
a) Harmonisation as a result of a balancing act by the legislature
34. The term ‘medicinal product’ does not appear in the EC Treaty. Nevertheless, the law governing medicinal products is governed and regulated to a considerable extent by Community law. EC law on medicinal products – like Community law on foodstuffs – was developed on the basis of the rules governing the free movement of goods. Medicinal products are included among the goods which form part of trade between Member States. However, they are products which, because of fundamental health dangers, require extraordinary precautions to be taken to guarantee the safety of the population. (7)
35. These measures are taken by the Member States, according to the modern view, as part of the State duty to protect health in pursuance of a fundamental State duty to provide protection. However, as long as and in so far as there are different national views on the necessary degree of protection and the appropriate methods for providing the level of safety, such rules are barriers to trade and thus almost classic cases of measures having equivalent effect to quantitative restrictions on imports within the meaning of Article 28 EC. (8) Under Article 30 EC they are justified only if they serve actual grounds of protection of health and are proportionate.
36. However, the harmonisation of the law on medicinal products at Community level is intended to remove precisely those justified barriers to trade with a view to establishing a single market as an area without internal borders. That aim is served by the secondary legislation, based first on Article 94 EC, then on Article 95 EC, to approximate national law on medicinal products, whereby, initially, terms such as medicinal product were defined for the purposes of Community law, the necessary material safety standards were approximated, and measures were taken in relation to the labelling of medicinal products and the facilitation and guaranteeing of the mutual recognition of national measures in the field of the law on medicinal products. A qualitatively new step was taken with the establishment of the uniform Community authorisation procedure. (9)
37. Harmonisation is carried out above all by means of directives which, according to the objective of Community law on medicinal products, essentially seek to safeguard public health. (10) 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. (11) The objectives of protection of health and free movement of goods are therefore both to be attained and must therefore be balanced. (12) Accordingly, harmonising directive 2001/83 should be regarded as the result of a balancing act by the legislature involving two Community objectives.
b) The meaning of the term ‘medicinal product’ under Community law
38. The Community legislature is free, within the limits laid down by the Treaty, to determine the extent of harmonisation. Full harmonisation of certain areas of the law on medicinal products therefore does not leave any room for separate national measures. With full harmonisation, the definition of ‘medicinal product’ in Article 1(2) of Directive 2001/83 is to be regarded as exhaustive, with the result that in describing products as ‘medicinal products’ the Member States are bound by that definition. (13) The competent national administrative authorities are therefore forbidden to bring products within the definition of medicinal products if, on the basis of objective criteria, they are not such products. (14)
39. If, however, the adoption of a decision of general application on the importation and marketing of a product is refused on the ground that it constitutes a medicinal product, even though the elements of the definition of medicinal product under Community law are not satisfied, that official action must be regarded as a failure to comply with the prescribed definition and thus an infringement of Community law in so far as that official action is based on an administrative practice. (15) Such an infringement inevitably gives rise to national liability on the part of the Member State in question.
40. In the present case, the Commission’s complaint is directed against an administrative practice on the part of the German authorities whereby products which consist of dried powdered garlic are treated as medicinal products.
41. The definition of ‘medicinal product’ under Directive 2001/83, just like the old definition in Directive 65/65/EEC, consists of two parts. A substance is a medicinal product if it is presented for treating or preventing disease in human beings (definition ‘by presentation’). It is also to be regarded as a medicinal product if it 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 (definition ‘by function’). A product is a medicinal product under Community law if it comes within one or other of those two definitions.
42. It should be noted in this connection that I expressly concur with the restrictive interpretation of the term ‘medicinal product’ under Directive 2001/83 advocated by Advocate General Geelhoed in his Opinion in HLH Warenvertrieb and Orthica. (16)
43. As Advocate General Geelhoed rightly argues in point 36 of his Opinion in HLH Warenvertrieb and Orthica, there are three objections to too broad an interpretation and application of the definition of medicinal product. First of all, the concept of ‘medicinal product’ would cease to have any differentiating effect if it were to include products whose properties and action did not justify their being classified as such. This would harm rather than serve the interests of human health. Secondly, it could result in the specific Community regulations for certain categories of food – containing provisions relating to the particular risks of the products – losing their regulatory object, like, in this case, Directive 2002/46 on food supplements. Thirdly, a ‘stealthy’ extension of the scope of Directive 2001/83 to include extraneous products would be detrimental to the free movement of goods.
44. Indications of a more restrictive interpretation of the term ‘medicinal product’ can be seen in the case-law. On the one hand, there is agreement that the legislation for medicinal products must be more stringent than for foodstuffs because particular dangers may be associated with their use. (17) On the other hand, the Court requires, for a product to be classified as a medicinal product, that there must be sufficient certainty that products which are claimed to have an effect as a medicinal product actually have that effect. (18) Logically, the existence of both the particular dangers and the effect as a medicinal product must be examined using information based on sound scientific research.
45. In my opinion, these considerations must be taken into account in the legal examination of the question, which is relevant to the present action for failure to fulfil obligations, whether the contested garlic preparation satisfies the criteria for classification of a product as a medicinal product, i.e. whether the classification made by the Federal Ministry of Health is consistent with Community law.
46. With regard to the possible limits of the judicial review of decisions of national authorities by the Court of Justice, it must be pointed out that under Community law the authorities concerned must enjoy a wide measure of discretion in performing duties which call for technical and scientific analyses. The Court concluded from this fact that the decision-making freedom of national authorities is subject only to a limited judicial review. In particular, the Community judicature may not substitute its assessment of the facts for that made by the authority in question. At the same time, however, the Court stressed that it had the tasks of examining the accuracy of the findings of fact and law made by that authority. (19) As a result, it is entirely within the power of the Community Courts, in an action for failure to fulfil obligations like the present case, to examine whether the elements of the definition of the term ‘medicinal product’ are satisfied in the individual case. It must therefore be examined below whether the garlic preparation at issue is a medicinal product within the meaning of the first subparagraph of Article 1(2) of Directive 2001/83.
47. Let me point out, moreover, that, as the Court has consistently held in proceedings under Article 226 EC, it is for the Commission to prove an alleged infringement of Community law. (20) In this case, therefore, it is primarily for the Commission to demonstrate and establish that the German Government misapplied Directive 2001/83, notwithstanding the discretion conferred on it, by wrongly treating the garlic preparation in question as a medicinal product. Of course, this does not preclude the Member State concerned from having to cooperate in the production of evidence by plausibly demonstrating, as the Court has stated in its case-law, on the basis of the results of international scientific research, that a given product is a medicinal product for the purposes of Directive 2001/83. (21) If the Commission wishes to contest the data furnished by the Member State, it must do so on the basis of equally reliable data.
2. Medicinal product by presentation
48. According to the case-law of the Court of Justice, the criterion of ‘presentation’ is designed to catch not only medicinal products having a genuine therapeutic or medical effect but also those which are not sufficiently effective or do not have the effect which consumers would be entitled to expect from the way in which they are presented. (22) This part of the definition of the term ‘medicinal product’ under Community law covers both ‘genuine’ medicinal products and preparations which do not have any pharmaceutical active substance and thus, from an objective perspective, cannot have any medical effect. As a result, according to case-law, the consumer is intended to be protected ‘not only from harmful or toxic medicinal products, but also from a variety of products used instead of the proper remedies’. (23) For that reason, the notion of the ‘presentation’ of a product has thus far been given a broad interpretation.
49. It must be assumed that a product is presented for treating or preventing disease within the meaning of Directive 2001/83 not only when it is expressly ‘presented’ or ‘recommended’ as such, possibly by means of labels, leaflets or oral representation, but also whenever any averagely well-informed consumer gains the impression, which, provided it is definite, may even result from implication, that the product in question should, having regard to its presentation, have the properties in question. (24) Reference must therefore be had to the intended use designated by the manufacturer, which is apparent to the consumer. (25)
50. According to the papers in the case, the contested product manufactured by Piddimax is a garlic extract powder which is sold in capsule form, each capsule containing the equivalent of 7.4 g of fresh, raw garlic. It is clear from the label, which was submitted with the application for the adoption of a decision of general application, that one capsule contains 370 mg of highly concentrated allicin-containing garlic extract powder.
51. I must concur with the Commission’s view that, apart from the capsule form in which the garlic preparation is marketed, there is nothing to suggest that it should be classified as a medicinal product by presentation. It should be borne in mind that, according to the case-law, the external form, such as a tablet, pill or capsule, may serve as strong evidence of the seller’s or manufacturer’s intention to market that product as a medicinal product. Such evidence cannot, however, be the sole or conclusive evidence, since otherwise certain food products which are traditionally presented in a similar form to pharmaceutical products would also be covered. (26) In fact, at present the capsule form has probably lost importance for possible classification as a medicinal product, especially since many food supplements as well as many dietetic foodstuffs are offered for sale in capsule, gelatine and tablet form, just like medicinal products. (27) Simply making reference to the marketing form would not take sufficient account of the fact that, for example, elements which were previously typical of medicinal products have become established on the market in food supplements in the interests of customer orientation and for reasons of expediency. (28) In addition, it is undoubtedly often essential for reasons of quality and practicability to offer food supplements for sale packaged in capsule form. It must therefore be assumed that an averagely well-informed consumer has now accepted the fact that this form is no longer specifically for medicinal products. The marketing of the contested garlic preparation in capsule form does not therefore automatically allow it to be classified as a medicinal product.
52. Furthermore, the fact that a ‘dosage’ and not a ‘portion of the product recommended for daily consumption’, as referred to in Article 6(3)(b) of Directive 2002/46, is indicated on the packaging cannot make the contested garlic preparation a medicinal product either. As the Commission rightly argues, that directive mentions elsewhere ‘dose form’ and ‘recommended daily dose’, which suggests that the terms ‘dosage’ and ‘portion of the product recommended for daily consumption’ essentially describe the same thing. Irrespective of terminological differences, a dosage cannot be the crucial factor in distinguishing between medicinal products and foodstuffs, as an appropriate maximum limit may prove to be necessary for the protection of health even in the case of certain foodstuffs which are not to be regarded as medicinal products.
53. Consequently, the contested garlic preparation does not satisfy the definition of the term ‘medicinal product’ by presentation under the first subparagraph of Article 1(2) of Directive 2001/83. Neither is the manner in which it is packaged typical of medicinal products, nor can the conclusion be drawn, on the basis of particular characteristics or indications from the manufacturer, that the manufacturer had the intention of marketing the garlic preparation as a medicinal product.
54. The two parts of the definition of the term ‘medicinal products’ under Community law cannot, however, be viewed as rigorously distinct. As the Court stated in van Bennekom, (29) a substance which is endowed with properties ‘for treating or preventing disease in human beings or animals’ within the meaning of the first part of the Community definition, but which is not ‘presented’ as such, falls within the scope of the second part of the Community definition of a medicinal product.
3. Medicinal product by function
55. The definition of a medicinal product by function laid down in the second subparagraph of Article 1(2) of Directive 2001/83 is to be understood as encompassing only substances or combinations of substances which may be administered to human beings with a view to modifying physiological effects. That definition of the term ‘medicinal product’ covers products which, actually or according to their claimed effects, can affect the body in such a way that they modify considerably the way in which it functions. (30)
56. In its case-law, the Court has mentioned the following criteria which may be used to determine whether a product falls under this part of the definition: its composition, its pharmacological properties – to the extent to which they can be established in the present state of scientific knowledge – the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail. (31) However, the Court has left open how those characteristics are to be assessed and has not yet provided any definition of ‘pharmacological properties’, except for stating that those properties include the ‘effect on health in general’. (32)
57. In my opinion, the criterion of the pharmacological properties (33) is of crucial importance because it is an objective characteristic which can be established only on a case-by-case basis by means of a thorough technical/scientific examination. The need for a clear definition of pharmacological properties is particularly evident in cases like the present one, which concern the classification of products which, in addition to their status as foodstuffs, are recognised as having health-promoting effects.
58. As Advocate General Tesauro rightly stated in Delattre, (34) the wording ‘restoring, correcting or modifying physiological functions’ contained in the second subparagraph of Article 1(2) of Directive 2001/83 is formulated in broad terms in order to extend to those products which, although without doubt inherently able to affect physiological functions, have an essentially nutritional purpose. I have already argued elsewhere that such an interpretation ultimately promotes neither the protection of health nor the free movement of goods. (35) Nor can that be the intention of the Community legislature. Concurring with the proposals made by Advocate Generals Geelhoed (36) and Tesauro, (37) I therefore take the view that the concept of a medicinal product by function must be interpreted restrictively. (38) Accordingly, the definition should cover only products with scientifically identifiable pharmacological properties. It should not be sufficient for the product merely to have physiological and nutritional effects. Rather, I consider that it must either be intended to prevent or treat disease, have relevant health risks or secondary effects which are detrimental to health, or have an excessive effect on physical functions. (39)
59. The German Government essentially justifies the classification of the product as a medicinal product by reason of its high allicin content which, according to its own information, has a two to four times higher concentration of active substances than the scientifically recommended daily dose. It argues that for that very reason the product is not a substance which should be treated in the same way as the foodstuff garlic, but rather a highly concentrated garlic extract obtained using ethanol which is cultivated on a medium (lactose). It sees evidence of pharmacological properties first of all in garlic’s effects in lowering blood pressure and lipid levels, which makes the preparation a suitable means for preventing general hardening of the arteries (general arteriosclerosis).
60. At this point, I believe that it should be pointed out that the legal assessment to be conducted by the Court must not be restricted to the health-promoting effect which garlic has as a foodstuff in the present state of scientific knowledge. Many products which are clearly foodstuffs according to the established view may also objectively serve therapeutic purposes. (40) On the basis of the restrictive interpretation of the definition of ‘medicinal product’ advocated here, the question must be asked whether the contested product in itself offers any additional benefit compared with garlic in its natural form.
61. On this question I tend to concur with the view taken by the Commission that the product in question in the present case is not a medicinal product. The literature on which the German Government relies in its defence explains the effect of the foodstuff garlic, which can be achieved through consumption of that foodstuff, but also by taking garlic preparations in the form of capsules, powders or solutions. (41) On closer examination the contested preparation proves to be nothing more than a concentrate of the natural active substance allicin, whose physiological effects can simply be achieved by taking a larger amount of the foodstuff garlic.
62. Whilst it is recognised that the use of garlic has a positive effect on the human body, its effect should not be regarded as any greater or different from that of other vegetable or animal products which are taken as part of the daily diet. As the Commission argues in its application, that effect can also be achieved by using other foodstuffs and by adopting a certain diet. For example, sea fish such as salmon, tuna, herring and sardines contain omega-3 fatty acids, which also reduce the risk of arteriosclerosis. In addition, vitamin C, vitamin E and the mineral selenium are important and can all be taken as part of normal foodstuffs, but also as food supplements.
63. I do not believe that the arguments put forward by Federal Government are conclusive enough to take the view that the product should be classified as a medicinal product ‘by function’ since the effects of such a preparation are not such as to prevent the risk of arteriosclerosis entirely. As can be seen from the letter from the German Government of 14 March 2003, which is Annex 4 to the application, apart from the active substance allicin the contested preparation does not contain any substances that could be classified as vitamins, minerals or other substances with a nutritional or physiological effect. (42)
64. In any case, any effect of a foodstuff in reducing risks or promoting health must not automatically lead to classification as a medicinal product, otherwise the Member States would be free to impede trade specifically in those valuable foodstuffs and thus withhold them from consumers. It is clear that such a consequence is directly contrary to the objectives of free movement of goods.
65. It is equally difficult to understand the German Government’s reference to the risks associated with the use of garlic. In so far as it refers to reports of spontaneous and post-operative bleeding, to possible interactions with the HIV medication Saquinavir and with certain medicinal products which stem blood clotting, the objection must be raised that the risks concerned are associated with taking garlic in general and are not to be attributed specifically to the preparation. As the Commission rightly notes, it is not unusual for an individual’s state of health possibly to require a certain diet to be observed, such as eating food that is low in salt or avoiding alcoholic drinks. Since those secondary effects occur very rarely and only where there is a certain inherited or situation-specific susceptibility, they should not really be regarded as relevant health risks or secondary effects which are detrimental to health within the meaning of the case-law. In addition, a possible health risk is just one of many factors which the competent national authorities have to take into account in classifying a product as a medicinal product ‘by function’. (43)
66. The German Government’s argument that an established view has been formed with regard to highly concentrated garlic preparations must also be rejected. That view fails to recognise that under Community law, to determine whether a product should be classified as a medicinal product, the national authorities must work on a case-by-case basis. (44) The blanket reference to an established view with regard to garlic products in general, for which no further evidence is given, does not relieve it of that duty. Furthermore, the Court has already held that consumers’ conceptions are likely to evolve in the course of the establishment of the internal market. (45) National rules must not result in certain consumer habits becoming entrenched in a way that would run counter to the establishment of the internal market.
67. All in all, therefore, the product does not fall within the definition of the term ‘medicinal product’ under Community law in accordance with Article 1(2) of Directive 2001/83.
68. Since the contested garlic preparation does not satisfy any of the legal definitions of ‘medicinal product’ contained in Article 1(2) of Directive 2001/83 and does not therefore fall within the scope ratione materiae of that provision, it is not necessary to comment on whether and to what extent the regime governing medicinal products takes priority over the rules on foodstuffs and food supplements. (46) The submissions made by the Federal Government in that regard must therefore be rejected as irrelevant in this case.
4. Applicability of the Treaty provisions on the free movement of goods
69. 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 the purpose of which is to supplement the normal diet and which is a concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form. However, the garlic preparation in question is not composed of the nutrients listed in Article 2(b) of Directive 2002/46 (vitamins and minerals) and is not therefore covered by the scope ratione materiae of that rule.
70. Under the eighth recital of Directive 2002/46, the Member States may, until such specific Community rules are adopted and without prejudice to the provisions of the Treaty, apply national rules concerning nutrients or other substances with nutritional or physiological effect used as ingredients of food supplements, for which no specific Community rules have been adopted.
71. In the absence of harmonisation in that sector, the Treaty provisions concerning free movement of goods therefore form the basis for assessing the compatibility of the classification of the product as a medicinal product by the German authorities.
5. Unjustified restriction of the free movement of goods
72. Under Article 28 EC, quantitative restrictions on imports and all measures having equivalent effect are prohibited between Member States. Measures having equivalent effect to a quantitative restriction are all rules and measures enacted by Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-community trade. (47)
73. The decision of 8 June 2000, by which the contested garlic product was refused authorisation as a food supplement in connection with the application under Paragraph 47a of the LMBG, is a national measure within the meaning of Article 28 EC. According to the grounds of the decision, the garlic product marketed lawfully in another Member State is regarded as a medicinal product in the Federal Republic of Germany. It may not therefore be marketed in Germany as a foodstuff or food supplement, but would have to be authorised as a medicinal product. That requirement is capable of impairing intra-Community trade in the product in question. It therefore constitutes a prohibited measure having equivalent effect.
74. The Court has stated that in default of harmonisation and to the extent that uncertainties continue to exist in the current state of scientific research, Member States may, in certain conditions, restrict on the basis of Article 30 EC the marketing of foodstuffs lawfully marketed in another Member State on grounds of the protection of the health and life of humans. (48) However, the measures taken by the Member States in relation to that product in order to safeguard public health must be proportionate. (49)
75. It is for the national authorities which invoke protection of public health to show in each case, in the light of national nutritional habits and in the light of the results of international scientific research, that their rules are necessary to give effective protection to the interests referred to in that provision and, in particular, that the marketing of the products in question poses a real risk to public health. (50) The burden of justification is heavier for the Member State in question, the higher the legal and factual requirements for marketing a product. It should be pointed out in this connection that the issue of a marketing authorisation under Article 8 of Directive 2001/83 is subject to strict requirements. (51)
76. Under these circumstances, the prohibition on marketing the product in question as a foodstuff and the obligation to obtain a marketing authorisation for medicinal products are regarded as proportionate only if they are actually necessary for the protection of the health of the population.
77. The German Government takes the view that the restriction of free movement of goods is in any case justified in order to protect an overriding public interest, namely to safeguard public health. In this respect it refers to its submissions on the health risks stemming from the preparation. (52)
78. As has already been explained, those arguments clearly relate to the effects of the foodstuff garlic, whilst they fail entirely to examine the contested preparation on a case-by-case basis. For example, the German Government does not clearly distinguish between the physiological effects resulting from the consumption of large quantities of garlic and from taking garlic preparations. In the letter from the German Government of 5 October 2001 to the Commission, reference is made to the foodstuff and the product to some extent indiscriminately, for example in connection with possible secondary effects such as gastrointestinal complaints, allergic reactions and slight lowering of blood pressure.
79. However, Article 30 EC may be relied on only if there actually exists a danger to the interest to which the Member State in question refers. (53) According to case-law, even if a situation of danger does not have to have been proven beyond scientific doubt, a substantiated and comprehensible case must be made in this regard. (54) Against the background of the high justification requirements which the Community legislature and the Court has imposed on the Member States, the mere blanket reference by the German Government to possible health risks which may arise from the consumption of garlic under very specific living conditions cannot be sufficient to justify such a drastic measure as the refusal of market access.
80. The German Government has not therefore shown that the issue of a marketing authorisation for the garlic preparation in question as a medicinal product was necessary to safeguard public health, especially since warnings for those who suffer allergies or those who have an inherited or situation-specific susceptibility to certain diseases are perfectly conceivable as a less onerous measure than a general marketing prohibition. (55)
81. To apply the requirements governing authorisation as a medicinal product to the contested garlic preparation therefore constitutes an unjustified restriction on the free movement of goods.
VII – Costs
82. Under Article 69(2) of the Rules of Procedure, in treaty infringement proceedings the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings. Since the Commission has applied for costs and the Federal Republic of Germany has been unsuccessful, it must be ordered to pay the costs.
VIII – Conclusion
83. On the basis of the foregoing considerations, I propose that the Court:
(1) 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, the Federal Republic of Germany has failed to fulfil its obligations under Articles 28 and 30 EC.
(2) order the Federal Republic of Germany to pay the costs.