Criminal proceedings against Jean Monteil and Daniel Samanni.
Date: 1991-03-21
10 Pursuant to the first subparagraph of Article 1(2) of Directive 65/65, a medicinal product is "any substance or combination of substances presented for treating or preventing disease in human beings or animals", and according to the second subparagraph "any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or in animals" is likewise regarded as a medicinal product.
11 The directive thus gives two definitions of medicinal products: a definition of medicinal products "by virtue of their presentation" and a definition of medicinal products "by virtue of their function". A product is a medicinal product if it falls within either of those definitions.
12 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.
17 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.
23 It must nevertheless be added that according to the judgment in Van Bennekom, supra, the concept of "presentation" of a product must be broadly construed and a product is "presented for treating or preventing disease" within the meaning of Directive 65/65 not only when it is expressly "indicated" 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 According to the same judgment, the external form given to the product in question may serve as strong evidence, but is not the sole or conclusive evidence; it must be stated that the "form" must be taken to mean not only the form of the product itself but also that of its packaging, which may, for reasons of marketing policy, tend to make it resemble a medicinal product, and account must also be taken of the attitude of an averagely well-informed consumer, in whom the form given to a product may inspire particular confidence similar to that normally inspired in him by proprietary medicinal products, having regard to the safeguards normally associated with the manufacture and marketing of the latter type of product.
27 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.
28 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.
29 Consequently, it is for the national authorities to determine, subject to review by the courts, whether or not eosin of a strength of 2% and modified alcohol of a strength of 70% constitute medicinal products by virtue of their function within the meaning of the second subparagraph of Article 1(2) of Directive 65/65. In that regard, account must be taken of the adjuvants also entering into the composition of the product, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail.
38 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.
39 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, at paragraph 10).