Criminal proceedings against Jean-Marie Delattre.
Date: 1991-03-21
16 It should be added that those two definitions cannot be regarded as strictly distinct from each other. As is stated in paragraph 22 of the judgment in Case 227/82 Van Bennekom [1983] ECR 3883, a substance which is endowed with "properties for treating or preventing disease in human beings or animals" within the meaning of the first Community definition but is not "presented" as such falls within the scope of the second Community definition of a medicinal product.
22 In those circumstances, even if it comes within the definition contained in Article 1(1) of Directive 76/768, a product must nevertheless be treated as a "medicinal product" and be made subject to the corresponding rules if it is presented as possessing properties for the treatment or prevention of illness or disease or if it is intended to be administered with a view to restoring, correcting or modifying physiological functions.
26 In order to decide whether a product of that kind must ultimately be classified as a foodstuff or as a medicinal product it is necessary, according to the judgment in Van Bennekom, supra, to consider each case individually having regard to the pharmacological properties of the product concerned, to such extent as they may have been established in the present state of scientific knowledge.
27 In any event, the fact 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 concerned when it displays the characteristics of such a product.
28 Although the essential purpose of Directive 65/65 may, as is indicated in the fourth recital in its preamble, be to remove obstacles to trade in proprietary medicinal products within the Community and although for that purpose Article 1 gives a definition of proprietary medicinal products and of medicinal products, it nevertheless constitutes, as is pointed out in the judgment in Van Bennekom, supra, merely a first stage in the approximation of national legislation on the production and distribution of pharmaceutical products.
29 At the present stage of development of Community law, it is difficult to avoid the continued existence, for the time being and, doubtless, so long as harmonization of the measures necessary to ensure the protection of health is not more complete, of differences in the classification of products as between Member States.
35 Consequently, it is for the national authorities to determine, subject to review by the courts, whether or not, having regard to its composition, the risks which might be associated with prolonged consumption of it and its characteristics in general, a product presented in the manner just described constitutes a medicinal product.
38 As has already been pointed out by the Court in its judgment in Van Bennekom, supra, to which, moreover, the national court refers, although the external form given to a product may serve as strong evidence of the seller' s or manufacturer' s intention to market the product as a medicinal product, it cannot 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.
48 It follows that as Community law stands at present, no harmonization of the rules on the marketing of medicinal products in each Member State having been carried out (judgment in Joined Cases 87/85 and 88/85 Legia v Minister for Health [1986] ECR 1707), the Member States continue to be empowered to lay down rules on the distribution, in the strict sense of the term, of pharmaceutical products, subject to compliance with the Treaty, in particular the provisions on the free movement of goods.
51 It follows that a monopoly granted to dispensing pharmacists in respect of the marketing of medicinal or other products is capable, in so far as it restricts sales to certain channels, of affecting the possibilities of marketing imported products and may accordingly constitute a measure having an effect equivalent to a quantitative restriction on imports within the meaning of Article 30 of the Treaty.
52 However, a monopoly for pharmacists may be justified by one of the general interests mentioned in Article 36 of the Treaty, which include the protection of health and life of humans. Moreover, since in principle it applies without distinction to domestic and imported products, that monopoly may also be justified on grounds of consumer protection, which, as the Court has held, is one of the imperative requirements which may justify a measure liable to hinder intra-Community trade (judgment in Case 25/88 Wurmser [1989] ECR 1105, paragraph 10).
53 In the absence of harmonization of the rules on the distribution both of medicinal products and of "para-pharmaceutical" products, it is for the Member States to choose the level to which they wish to ensure the protection of public health.
54 In the case of medicinal products within the meaning of Directive 65/65, account must be taken of the very particular nature of the product and the market involved, which explains the fact that in all the Member States there are, albeit with differences of detail, rules restricting their marketing and, in particular, some form of monopoly on the retail sale of such products is granted to pharmacists by reason of the safeguards which pharmacists must provide and the information which they must be in a position to furnish to the consumer.
56 It follows that although in principle the Member States may reserve to pharmacists the right to make retail sales of products that fall within the Community definition of medicinal products and although, in those circumstances, their monopoly over those products may be presumed to constitute an appropriate way of protecting public health, evidence to the contrary may be produced with respect to certain products whose use would not involve any serious danger to public health and whose inclusion within the pharmacists' monopoly would seem manifestly disproportionate, that is to say contrary to the principles laid down by the Court for the interpretation of Articles 30 to 36 of the Treaty.