Commission of the European Communities v Republic of Austria.
Date: 2004-04-29
56. It follows from Articles 2 and 3 of Directive 65/65 that no medicinal product produced industrially may be placed on the market in a Member State unless a marketing authorisation has been issued.
57. Accordingly, if a product produced industrially comes within the definition of medicinal product in Article 1(2) of Directive 65/65, the obligation on the importer of that product to obtain a marketing authorisation in accordance with that directive prior to marketing it in the Member State of importation cannot in any event constitute a restriction on trade between Member States prohibited by Article 28 EC (see, to that effect, Case C-322/01 Deutscher Apothekerverband  [2003] ECR I-14887, paragraphs 48, 52 and 53).
58. Furthermore, although the essential purpose of Directive 65/65 is to remove obstacles to trade in medicinal products within the Community and although for that purpose Article 1 gives a definition of medicinal products, it nevertheless constitutes merely a first stage in the harmonisation of national legislation on the production and distribution of pharmaceutical products (see, in particular, Commission v Germany , paragraph 15).
59. As Community law stands, so long as harmonisation of the measures necessary to ensure the protection of health is not more complete, it is difficult to avoid the existence of differences in the classification of products as between Member States in the context of Directive 65/65 (see, inter alia, Case C-201/96 LTM [1997] ECR I-6147, paragraph 24, and Case C-270/96 Laboratoires Sarget [1998] ECR I-1121, paragraph 23).
60. The fact therefore that a product is classified as a foodstuff in another Member State cannot prevent its being classified as a medicinal product in the Member State of importation if it displays the characteristics of such a product (see, inter alia, Delattre , paragraph 27; LTM , paragraph 24; and Laboratoires Sarget , paragraph 23).
63. In so far as vitamins or minerals are usually defined as substances which, in minute quantities, form an essential part of the daily diet and are indispensable for the proper functioning of the body, they cannot, as a general rule, be regarded as medicinal products when they are consumed in small quantities. Similarly, it is a fact that vitamin preparations or preparations containing minerals are sometimes used, generally in large doses, for therapeutic purposes in combating certain diseases other than those of which the morbid cause is a vitamin or mineral deficiency. In such cases, it is beyond dispute that those preparations constitute medicinal products (see, in respect of vitamins, Van Bennekom , paragraphs 26 and 27).
64. In those circumstances, and in accordance with settled case-law, to determine whether vitamin preparations or preparations containing minerals should be classified as medicinal products within the meaning of Directive 65/65, the national authorities, acting under the control of the court, must work on a case-by-case basis, having regard to all of their characteristics, in particular their composition, their pharmacological properties – to the extent to which they can be established in the present state of scientific knowledge –, the manner in which they are used, the extent of their distribution, their familiarity to consumers and the risks which their use may entail (see, inter alia, Van Bennekom , paragraph 29; Case C-60/89 Monteil and Samanni [1991] ECR I-1547, paragraph 29; Case C‑112/89 Upjohn [1991] ECR I-1703, paragraph 23; and Commission v Germany , paragraph 17).
65. Accordingly, a risk to public health is only one aspect of the product which must be taken into consideration by the competent national authorities. It is obvious that a product which does not pose a real risk to health can nevertheless have an effect on the functioning of the body. To classify a product as a ‘function’ medicinal product, those authorities must ascertain that it is intended to restore, correct or modify physiological functions and that it may thus have an effect on health in general ( Upjohn , paragraph 17).
71. As for vitamins A, D and K, even if they are liposoluble vitamins, which it is accepted pose a higher risk of harmfulness than water-soluble vitamins as a rule (see Sandoz , paragraph 11, and Van Bennekom , paragraph 36), the Austrian Government merely calls to mind the risk of a dangerous overdose, without stating from what quantities there is uncertainty about the harmlessness of intake of those vitamins or the nature of the risks taken if those quantities are exceeded, and without citing the scientific opinions on which it relies.
75. The Austrian Government also contended in the oral procedure that it is not uncommon for consumers of food supplements to take higher doses than those stated in the instructions, which increases the risk of exceeding the maximal dose. However, almost all products are potentially harmful to health if they are consumed in excessive quantities, so that in order to determine whether a product is a ‘function’ medicinal product the normal conditions of use should be taken into account.
79. In those circumstances, it is for the Commission to explain the reasons for which the Austrian authorities have, in its opinion, exceeded the bounds of their discretion in classifying preparations containing chromate salts as medicinal products (see, to that effect, Commission  v Germany , paragraph 20; see also, to that effect, Case C-24/00 Commission  v France  [2004] ECR I-1277, paragraph 72). Clearly, the Commission has not furnished that proof. The action is therefore unfounded so far as concerns those preparations.
80. It follows from the foregoing arguments that, except for chomate salts, the Austrian practice cannot be validated on the basis of Directive 65/65. It is therefore appropriate to determine, secondly, whether the requirement of a marketing authorisation as a medicinal product, for which the Austrian practice provides, constitutes a measure having an effect equivalent to a quantitative restriction on imports, prohibited by Article 28 EC, and, if so, whether such a requirement may nevertheless be justified on grounds of public health referred to in Article 30 EC.
81. The prohibition on measures having an effect equivalent to quantitative restrictions laid down in Article 28 EC relates to all rules enacted by Member States which are capable of hindering, directly or indirectly, actually or potentially, intra-Community trade (see, inter alia, Case 8/74 Dassonville  [1974] ECR 837, paragraph 5, and Case C-192/01 Commission  v Denmark  [2003] ECR I‑9693, paragraph 39).
83. The Court has already ruled that a product which is not a medicinal product within the meaning of the provisions of Article 1(2) of Directive 65/65 may, subject to Article 28 EC et seq. concerning products imported from other Member States, be subject in the domestic law of a Member State to the rules governing medicinal products ( Van Bennekom , paragraphs 15, 30, 31 and 38; Case 35/85 Tissier  [1986] ECR 1207, paragraph 22; and Case C-219/91 Ter Voort  [1992] ECR I-5485, paragraph 42).
85. In that respect, it is for the Member States, in the absence of harmonisation and in so far as there are uncertainties in the present state of scientific research, to decide on the degree of protection of the health and life of humans they intend to ensure and on the requirement for an authorisation prior to placing foodstuffs on the market, having regard, however, to the requirements of the free movement of goods within the Community ( Sandoz , paragraph 16; Van Bennekom , paragraph 37; Commission  v Denmark , paragraph 42; and Case C-24/00 Commission  v France , paragraph 49).
86. That discretion relating to the protection of public health is particularly important when it is established that there are uncertainties in the present state of scientific research into certain substances, such as vitamins which are not as a general rule harmful in themselves but which may have particular harmful effects solely if taken to excess as part of a general diet, the composition of which is unforeseeable and cannot be monitored ( Sandoz , paragraph 17; Commission  v Denmark , paragraph 43; and Case C-24/00 Commission  v France , paragraph 50).
87. Community law does not therefore, in principle, preclude a Member State from prohibiting, save with prior authorisation, the marketing of foodstuffs incorporating nutrients, such as vitamins or minerals other than those whose addition is lawful under Community legislation ( Commission  v Denmark , paragraph 44; and Case C-24/00 Commission  v France , paragraph 51).
88. However, in exercising their discretion relating to the protection of public health, the Member States must comply with the principle of proportionality. The means which they choose must therefore be confined to what is actually necessary to ensure the safeguarding of public health; they must be proportional to the objective thus pursued, which could not have been attained by measures which are less restrictive of intra-Community trade (see Sandoz , paragraph 18; Van Bennekom , paragraph 39; Commission  v Denmark , paragraph 45; and Case C‑24/00 Commission  v France , paragraph 52).
89. Furthermore, since Article 30 EC contains an exception, to be interpreted strictly, to the rule of free movement of goods within the Community, it is for the national authorities which invoke it 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 ( Sandoz , paragraph 22; Van Bennekom , paragraph 40; Commission  v Denmark , paragraph 46; and Case C-24/00 Commission  v France , paragraph 53).
94. In those circumstances, the Austrian practice may be regarded as proportionate only if the prohibition on marketing as foodstuffs the vitamin preparations or preparations containing minerals concerned and the obligation to obtain a marketing authorisation for medicinal products are both actually necessary, in each particular case, to ensure the safeguarding of public health. The argument of the Austrian Government that that practice is necessarily proportionate on the ground that the preparations concerned can in any case be marketed as medicinal products cannot therefore be accepted.
96. Accordingly, the systematic nature of that practice does not make it possible to identify and assess a real risk to public health, which requires a detailed assessment on a case-by-case basis of the effects which the addition of the vitamins in question could entail (see, to that effect, Commission  v Denmark , paragraph 56).