Judgment — ECLI:EU:C:2009:5
Date: 2009-01-15
Language of the case: German
Court formation: First Chamber
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Free movement of goods;Approximation of laws;Public health
Concepts: Scope of the legislation;Medicinal products by function
Procedure: Reference for a preliminary ruling
Origin: Germany

summary or even criminal offences. Finally, the distinctions are also relevant in administrative law. In particular, the law governing the safety of medicinal products provides the competent supervisory authorities with an array of intervention powers by which they can take decisive steps merely on the basis of a suspicion that an unauthorised medicinal product may have been placed on the market. 6 – 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 (OJ 2002 L 31, p. 1). 7 – 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 (OJ 2002 L 183, p. 51). 8 – This view is evidently shared by some German-language academic writers, to whom the Bundesverwaltungsgericht refers in its order for reference. In general, the issue of the function of the rule of doubt in Article 2(2) of Directive 2001/83 is controversial. For an interpretation as a rule of presumption or a rule of evidence, see Dettling, H.-U, ‘Physiologische, pharmakologische und toxikologische Wirkung – Ein Beitrag zur Abgrenzung von Lebensmitteln, Arzneimitteln und gefährlichen Stoffen (Teil 1)’, Lebensmittel & Recht, 2007, part 1, p. 8, who takes the view that, with regard to the rule of doubt in Article 2(2) of Directive 2001/83, it is sufficient for the requirement for the status of a substance or a preparation of substances as a medicinal product that it is not obviously unsuited to achieving an actively useful effect. Kraft, F. /Röcke, T., ‘Auswirkungen der neuen Zweifelsregelung in Article 2(2) der Arzneimittelrichtlinie 2001/83/EG auf die Einstufung von Grenzprodukten als Lebens- oder Arzneimittel’, Zeitschrift für das gesamte Lebensmittelrecht, 2006, part 1, p. 34, take the view that the rule of doubt is equivalent to a rule on the burden of proof. The authority applying the law need not be entirely certain whether it has to deal with a medicinal product or with a foodstuff. However, it is bound under the provision to apply the provisions governing medicinal products legal provisions even though it is not entirely certain. 9 – Case C‑369/88 Delattre [1991] ECR I‑1487, paragraph 22. 10 – Case C‑60/89 Monteil and Samanni [1991] ECR I‑1547, paragraph 17. 11 – Case C‑219/91 Ter Voort [1992] ECR I‑5485, paragraph 19. 12 – Case C‑319/05 Commission v Germany [2007] ECR I‑9811, paragraphs 38 and 63. 13 – In my Opinion in Commission v Germany, cited above, point 44, I referred to the fact that the legislation governing medicinal products must necessarily be more stringent than that governing foodstuffs in view of the particular dangers which may be associated with their use. 14 – Joined Cases C‑211/03, C‑299/03 and C‑316/03 to C‑318/03 HLH Warenvertrieb and Orthica [2005] ECR I‑5141, paragraphs 43 to 45). In that case, in order to support its theory that ‘the provisions of Community law specific to medicinal products [must be applied] to a product which satisfies equally well the conditions for classification as a foodstuff and the conditions for classification as a medicinal product’, the Court refers to the judgment in Ter Voort. The Court regards this interpretation as being confirmed by Directive 2004/27, which introduced the abovementioned rule of doubt in Article 2(2) of Directive 2001/83. 15 – Meisterernst, A., also agrees: ‘Mit dem Wissen wächst der Zweifel’, Zeitschrift für das gesamte Lebensmittelrecht, 2007, part 3, p. 393; in his view HLH Warenvertrieb and Orthica appears rather to support the view that the rule of doubt should not be taken as a rule of evidence but only as a rule that the law on medicinal products takes precedence in the event that a product actually meets in full the definition of a medicinal product and also that of one of the other product categories, for example that of foodstuffs or cosmetic products. 16 – Opinion of Advocate General Geelhoed in HLH Warenvertrieb and Orthica, point 52. 17 – Article 2(d) of Regulation No 178/2002 states: ‘“Food” shall not include [for the purposes of that regulation]: medicinal products within the meaning of Council Directives 65/65/EEC and 92/73/EEC’. Köhler, H., ‘Die neuen europäischen Begriffe und Grundsätze des Lebensmittelrechts’, Gewerblicher Rechtsschutz und Urheberrecht, 2002, part 10, p. 845, infers from the exclusion of medicinal products from the scope of application of that directive that foodstuffs and medicinal products are mutually exclusive categories. He submits that a product can be either a medicinal product or a foodstuff, but not both at the same time. In addition, fulfilling the medicinal product requirements represents a more specific requirement than fulfilling that relating to foodstuffs. If a product is to be classified as a medicinal product, it is at the same time clear that it cannot be a foodstuff. The author considers his opinion to be confirmed in Article 2(2) of Directive 2001/83, a provision which, he submits, serves to determine the scope of application of Directive 2001/83. However, the author considers this rule of precedence to have already been enshrined in the older (in terms of legislative history) negative rule contained in Article 2(d) of Regulation No 178/2002. 18 – Article 1(2) of Directive 2002/46 states as follows: ‘This Directive shall not apply to medicinal products as defined by 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.’ 19 – The version of Article 2(2) of Directive 2001/83 originally proposed by the Commission read: ‘Whenever a substance or combination of substances falls within the definition of “medicinal product”, the provisions of this Directive shall apply, even in cases where the substance or combination of substances falls also within the scope of other Community legislation.’ (Commission Proposal of 26 November 2001 for a Directive of the European Parliament and of the Council amending Directive 2001/83 on the Community code relating to medicinal products for human use, COM[2001] 404 final). In the justification for its proposal the Commission stated that it was necessary, in view of the growing number of so-called ‘borderline products’, to modify the definition of ‘medicinal product’ ‘so as to avoid any doubt as to the applicable legislation, when a product, whilst fully falling within the definition of a medicinal product, may also fall within the definition of other regulated products’. The Commission considered that taking into account the characteristics of pharmaceutical legislation, provision should be made that such legislation should apply. In its report on the Commission’s proposal, the European Parliament (Session document A5‑0340/2002, Amendments 18-23) of 9 October 2002 proceeded on the basis of a ‘hierarchy of legislation on medicinal products’. It stated that according to this hierarchy, in cases of doubt whether a product is a medicinal product, the legislation on medicinal products was to apply. 20 – On this note see also Büttner, T., ‘Die Zweifelsregelung enthebt nicht der Prüfung, ob ein Medicinal product vorliegt’, Zeitschrift für das gesamte Lebensmittelrecht, 2006, part 6, p. 774, who is of the opinion that the term ‘case of doubt’ means that a product fulfils both the requirements of another product category and the requirements of a medicinal product. Since the requirements for both product categories are fulfilled, doubt arises as to the classification of the product. 21 – The formulation in the seventh sentence of the seventh recital of Directive 2004/27 stems from a concern raised by the European Parliament, which proposed, in its amendments in relation to the Commission’s original proposal (Report of 9 October 2002, Session document A5‑0340/2002, Amendments 18-23), inter alia, exclusion clauses for food, medical devices and cosmetics. These exclusion clauses were intended to close regulatory loopholes. However, the Commission was of the opinion that such exclusion clauses would not have been compatible with the device of enshrining the precedence of the medicinal product regime, on which it based its proposal. The Commission was accordingly not prepared to incorporate it in the text of its amended proposal for a directive. Instead, it proposed a reformulation of the seventh recital (amended proposal for a Directive of the European Parliament and of the Council of 3 April 2003 amending Directive 2001/83 on the Community code relating to medicinal products for human use (COM[2003] 163 final, p. 11, 12), which the Council ultimately adopted (Common Position [EC] No 61/2003 of 29 September 2003 (2003/C 297 E/02)). 22 – Meisterernst, A., cited above (footnote 15), p. 393, is of the opinion that the seventh sentence, which is based on the premises that a product clearly falls within the definition of other product groups, here only represents a supposed contrast to the second sentence of recital 7. It is merely intended that the rule of doubt should only apply in cases of doubt and not if a product clearly falls to be categorised in one or other product group. According to Büttner, T., cited above (footnote 20), p. 771, recital 7 in the preamble to Directive 2004/27 corresponds exactly in terms of content to the wording of Article 2(2) of Directive 2001/83. Büttner argues that recital 7 says nothing other than that, where there is a clear classification of a product under the definition of another product group, the law on medicinal products should not apply. In the same way, Article 2(2) of Directive 2001/83 provides that the rule of doubt may actually apply only in cases of doubt. Accordingly, there is no contradiction between the recitals and the wording of Article 2(2) of Directive 2001/83. 23 – Groß, T., in ‘Neues zur Abgrenzung zwischen Lebensmittel und Arzneimittel’, Europäische Zeitschrift für Wirtschaftsrecht, 2006, part 6, p. 175, also agrees and explains, referring to the legislative history of Directive 2004/27, that the provision, the text of which states that, where there are difficulties in classifying a product, in the event of doubt a product should be classified as a medicinal product, reflects the case-law of the Court. According to Schroeder, W., ‘Die rechtliche Einstufung von Nahrungsergänzungsmitteln als Lebens- oder Arzneimittel – eine endlose Geschichte?’, Zeitschrift für das gesamte Lebensmittelrecht, 2005, part 4, p. 421, the rule of doubt is merely declaratory in nature and does not change the position in law, pursuant to which a product which can be defined as both a foodstuff and a medicinal product, must primarily be considered in accordance with the law on medicinal products. In the view of Peigné, J., ‘La réforme de la législation pharmaceutique communautaire’, Revue de droit sanitaire et social, 2004, No 3, p. 580, the provision in Article 2(2) of Directive 2001/83 is consistent with the previous case-law on the precedence of the law relating to medicinal products. 24 – See my Opinion in Commission v Germany (cited in footnote 13), point 44. 25 – Judgments in Commission v Germany (cited in footnote 12), paragraph 55; Case C‑387/99 Commission v Germany [2004] ECR I‑3751, paragraph 57; Case C‑112/89 Upjohn [1991] ECR I‑1703, paragraph 23; Case C‑290/90 Commission v Germany [1992] ECR I‑3317, paragraph 17; Monteil and Samanni (cited in footnote 10), paragraph 2; and Case 227/82 Van Bennekom [1983] ECR 3883, paragraph 29. See Doepner, U./Hüttebräuker, A., ‘Abgrenzung Arzneimittel/Lebensmittel – die aktuelle gemeinschaftsrechtliche Statusbestimmung durch den EuGH’, Wettbewerb in Recht und Praxis, 2005, part 10, p. 1199, who conclude, with reference to this case-law, that to some extent the Court clearly wants to discourage attempts by Member States to advocate an expansion of the respective national regimes governing medicinal products in order to cover ambivalent products. 26 – Reinhart, A., in ‘Zur Abgrenzung Arzneimittel/Lebensmittel im Lichte der BasisVO und des gemeinschaftsrechtlichen Arzneimittelbegriffs“, Zeitschrift für das gesamte Lebensmittelrecht, 2005, part 4, pp. 510-512, correctly refers to the fact that the rule of doubt under Article 2(2) of Directive 2001/83, as amended by Directive 2004/27, is a confirmation of the previous case-law. He argues that the rule of doubt may only apply once all of the circumstances of the individual case have been comprehensively considered and it has been positively determined that the product comes within both the medicinal product definition and the definition of foodstuff (or another product). In order to apply this provision it is not sufficient if, although a pharmacological effect cannot be excluded, it cannot ultimately be confirmed either. Classification as a foodstuff can only be rejected – and in cases of demarcation vis-à-vis medicinal products, classification as a medicinal product can only be affirmed – if the existence of a medicinal product within the meaning of the Community Code for human medicinal products has been positively established. In the opinion of Gorny, D., ‘Funktionelle Nahrungsergänzungsmittel im Schnittpunkt der Begriffe Arzneilmittel, Lebensmittel und Zusatzstoffe’, Zeitschrift für das gesamte Lebensmittelrecht, 2005, part 1, p. 124, a very careful comprehensive consideration of all the characteristics of the product to be assessed is required. The rule of doubt, it is argued, applies only once a product may be both a foodstuff in the form of a functional food supplement and a medicinal product. 27 – Klein, A., cited above (footnote 5), p. 795, calls for the objective determination of the function of a product within the context of a scientific review. In the opinion of Callens, S., Chapters on pharmaceutical law, Antwerp/Groningen/Oxford 2000, pp. 9 and 10, a product’s characteristics as a medicinal product must be capable of being determined on the basis of the present state of scientific knowledge. 28 – The national authorities remain free to invoke the precautionary principle in certain cases, in which, after an evaluation of the information available, the possibility of effects which are harmful to health is established, but there is still scientific uncertainty (see in relation to this the Communication from the Commission of 2 February 2000 on the applicability of the precautionary principle, COM[2000] 1 final). This allows interim risk-management measures to be taken in order to ensure the high level of protection of health chosen for the Community, until further scientific information is available for a more comprehensive risk assessment. The steps to be taken must, however, be proportionate and may not have a greater impact on the free movement of goods than is necessary to achieve the high level of protection of health chosen for the Community, regard being had to technical and economic feasibility and other factors which it is considered need to be taken into account in view of the relevant facts of the case. The precautionary principle has found its way into food law through its express inclusion in Article 7 of Regulation (EC) No 178/2002. 29 – Judgments in Case 174/82 Sandoz [1983] ECR 2445, paragraph 16; Van Bennekom (cited in footnote 25), paragraph 37; Case C‑192/01 Commission v Denmark [2003] ECR I‑9693, paragraph 42; Case C‑24/00 Commission v France [2004] ECR I‑1277, paragraph 49; and Commission v Germany (cited in footnote 25), paragraph 68. 30 – Judgments cited in Footnote 29: Sandoz (paragraph 17), Commission v Denmark (paragraph 43), Commission v France (paragraph 50); and Commission v Germany (paragraph 69). 31 – As I stated in my Opinion in Commission v Germany (cited in footnote 13), points 34 to 37), the harmonising effect achieved by the Community law on medicinal products should be regarded as the result of a balancing act by the legislature between the objectives of free movement of goods and protection of health. Both objectives are therefore to be attained and must therefore be balanced. In Pierrel (Case C‑83/92 Pierrel [1993] ECR I‑6419, paragraph 7), the Court established that, in Community law, proprietary medicinal products are the subject of a series of highly detailed harmonisation directives aiming at the gradual attainment of the free movement of those products in the Community, while at the same time safeguarding public health. On this note see also auch Cadeau, E./Richeux, J.‑Y., ‘Le juge communautaire et le médicament: libre circulation des marchandises et protection de la santé publique’, Les petites affiches, 1996, No 7, p. 4. According to Fraguas Gadea, L., ‘La libre circulación de medicamentos’, Noticias de la Unión Europea, 2000, No 184, p. 57, and Petit, Y., ‘La notion de médicament en droit communautaire’, Revue de droit sanitaire et social, 1992, 28th year, No 4, p. 572, the Community legislature has promoted harmonisation in order to achieve a fair balance between the needs of public health and the free movement of goods. The latter could, in the view of the authors, also be described in a broader sense as a project to establish a common European market for medicinal products. 32 – Consequently, a national practice which requires the grant of a marketing authorisation for medicinal products in order to place food supplements on the market constitutes a measure having an effect equivalent to a quantitative restriction on imports, within the meaning of Article 28 EC, which may nevertheless be justified on grounds of public health pursuant to Article 30 EC (see, to that effect, Cases C‑150/00 Commission v Austria [2004] ECR I‑3887, paragraphs 81to 83, and Van Bennekom (cited in footnote 25), paragraph 33). 33 – See my Opinion in Commission v Germany (cited in footnote 13), point 43. See also the Opinion of Advocate General Geelhoed in HLH Warenvertrieb and Orthica (cited in footnote 16), point 36. 34 – According to Büttner, T., cited above (footnote 20), p. 751, 761, the precedence of the law on medicinal products does not relieve the authorities from the obligation to actually examine in detail whether a substance has a pharmacological effect and therefore is or is not a medicinal product by function. The author refers both to the disadvantages of an unduly extensive interpretation and application of the concept of a medicinal product for the free movement of goods and the protection of health and to the criminal-law consequences of marketing a product which is considered to require authorisation but which has not, however, been authorised. In his opinion, those responsible for marketing a product would have to anticipate criminal law sanctions although it had never actually been established whether the product in fact fulfilled the requirements for a medicinal product. He argues that this is not compatible with the specific principle of criminal procedure ‘in dubio pro reo’ or with the clarification principle applicable in the German law of administrative procedure. Against this, however, Kraft, F., „Klare Worte zur Zweifelsregelung“, Zeitschrift für das gesamte Lebensmittelrecht, 2006, part 6, p. 750, who, on the one hand, interprets the rule of doubt in Article 2(2) of Directive 2001/83 to the effect that it does not require a positive determination that a product has the characteristics of a medicinal product, but allows residual doubt, but, on the other hand, refers to the risk that the rule of doubt could be used as a pretext to classify a product as a medicinal product prematurely on the basis of an unclear factual situation. 35 – Upjohn (cited in footnote 25), paragraph 18. 36 – Point 64 of this Opinion. 37 – Van Bennekom (cited in footnote 25), paragraphs 26 and 27. 38 – Van Bennekom, paragraph 28. 39 – Commission v Germany (cited in footnote 25), paragraphs 77 to 83. 40 – See Commission v Germany (cited in footnote 25), paragraph 79. In that case the Court criticised the fact that the automatic nature of this administrative practice made it impossible to identify and assess a real risk to public health, which would have required a detailed assessment on a case-by-case basis of the effects which the addition of the vitamins in question might entail. In Commission v Denmark (cited in footnote 29), paragraph 56, the Court criticised an administrative practice under which enriched foodstuffs lawfully produced or marketed in other Member States could be marketed in Denmark only if it was shown that such enrichment with nutrients corresponded to a need in the Danish population. 41 – Also of this Opinion: Dettling, H.‑U., cited above (footnote 8), p. 8, who takes into account the actual dosage. He refers to that fact that in many substances and preparations derived from substances different effects may be produced depending on the dosage and that harmful side effects had to be faced with almost all medicinal products. In his opinion, in order for a product to be considered to be a medicinal product, its useful modifying effect on bodily functions, in the actual dosage, combination, pharmaceutical form and application, had to be the main effect of the substance or the preparation made from substances. Similarly also Büttner, T., cited above (footnote 20), p. 762, who states that the dosage of a substance is decisive. Büttner states that it is true that a number of vitamins, minerals and other substances have authorisations as medicinal products. However, from this it cannot be concluded that, as a matter of principle, a therapeutic purpose and a pharmacological effect have to be assumed. On the contrary, this writer argues that an exact differentiation must be made according to the dosage from which authorisation as a medicinal product was granted. Kraft, F., cited above (footnote 34), p. 751, states that the mere fact that a substance is contained in an authorised medicinal product is not in itself sufficient to justify the assumption that, as a matter of principle, a food supplement containing this substance has pharmacological effects. This applied in particular to ‘dual-use’ substances, which, depending on the dose administered, could be used for either nutritional-physiological or medicinal purposes. 42 – Sandoz (cited in footnote 29), paragraph 71. 43 – Van Bennekom (cited in footnote 25), paragraph 39; Commission v Denmark (cited in footnote 29), paragraph 45; Commission v France (cited in footnote 29), paragraph 52; and Commission v Germany (cited in footnote 25), paragraph 71. 44 – Van Bennekom (cited in footnote 25), paragraph 40. 45 – See my Opinion in Commission v Germany (cited in footnote 13), point 75. In Commission v Germany (cited in footnote 25), paragraphs 74 to 76, in relation to the conditions for the authorisation of vitamin preparations as medicinal products pursuant to Article 4 of Directive 65/65, which substantially correspond to those of Article 8 of Directive 2001/83, the Court stated that the issue of a marketing authorisation for medicinal products is subject to particularly strict requirements. Accordingly, in order to obtain a marketing authorisation, the person responsible for placing the product on the market must attach various particulars and documents to the application, including qualitative and quantitative particulars of all the constituents of the medicinal product, a brief description of the method of preparation, therapeutic indications, contra-indications and side-effects, posology, pharmaceutical form, method and route of administration and expected shelf life, description of control methods employed by the manufacturer, results of physico-chemical, biological or microbiological tests, pharmacological and toxicological tests, and clinical trials. Moreover, the person responsible for placing the product on the market must provide proof that the manufacturer is authorised in its own country to produce medicinal products. 46 – In the view of Büttner, T., cited above (footnote 20), p. 765, the national court may not be excused from its duty to examine whether a product demonstrates a pharmacological effect, and specifically on the basis of the actual recommended daily dosage. 47 – See point 64 of this Opinion. 48 – The Court has, however, left open how those characteristics are to be assessed and has so far not provided any definition of pharmacological properties, except for stating that those properties include the ‘effect on health in general’. I referred to this in my Opinion in Commission v Germany (cited in footnote 13), point 56. Thus, the Court most recently held in Commission v Germany (cited in footnote 12), paragraph 59, referring to HLH Warenvertrieb and Orthica (cited in footnote 14), paragraph 52, that the pharmacological properties of a product are the factor on the basis of which it must be ascertained, in the light of the potential capacities of the product, whether it may, for the purposes of the second subparagraph of Article 1(2) of Directive 2001/83, be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings. 49 – See point 64 of this Opinion and the case-law cited in footnote 25. 50 – HLH Warenvertrieb and Orthica (cited in footnote 14), paragraph 53, and Commission v Austria (cited in footnote 32), paragraphs 64 and 65. 51 – See in particular Upjohn (cited in footnote 25), paragraph 20, in which the Court referred to the wording of the legal definition of a medicinal product by function in Directive 65/65. Pursuant to that definition, those products had to be regarded as medicinal products on the basis of their function ‘which are intended to restore, correct or modify physiological functions and which may thus have an effect on health in general’. The Court decided that the fact that the provision uses the expression ‘with a view to’ means that the definition of a medicinal product may include not only products which have a real effect on physiological functions but also those which do not have the advertised effect, thereby enabling public authorities to prevent the marketing of such products in order to protect consumers. 52 – This subjective term features in several language versions. German: ‘um … zu’; English: ‘with a view to’; French: ‘en vue … de’; Spanish: ‘con el fin de’; Italian: ‘allo scopo di’; Dutch: ‘om … te’; Portuguese: ‘com vista a’. 53 – See Groß, T., cited above (footnote 23), pp. 174 and 175, who also refers to the subjective expression ‘with a view to’ in Article 1(2)(b) of Directive 2001/83, as amended by Directive 2004/27. Schroeder, W., cited above (footnote 23), pp. 420 and 422, assumes that the new definition of medicinal product by function does not change the previous legal position. Peigné, J., cited above (footnote 23), p. 581, clearly also proceeds on the basis of a broad interpretation of the definition of medicinal product by function.