Opinion of Advocate General

Mr President,

Members of the Court,

1. The questions referred to the Court for a preliminary ruling by the Arrondissementsrechtbank (District Court), Leeuwarden (Netherlands), relate to the interpretation of the concept of medicinal products by virtue of their presentation contained in the first subparagraph of Article 1(2) of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products.

2. Before considering the individual questions, it is appropriate to recall that Directive 65/65, whose aim is to eliminate hindrances to the free movement of medicinal products and, at the same time, to safeguard public health, requires Member States to subject to prior authorization the placing of proprietary medicinal products on the market (Article 3). Proprietary medicinal product is defined as any ready-prepared medicinal product placed on the market under a special name and in a special pack.

3. The national court's first question seeks to establish whether a product presented as having curative or preventive properties falls within the definition in the first subparagraph of Article 1 (2) of Directive 65/65 even where, as in this case, the product in general is regarded as a foodstuff and in accordance with current scientific knowledge does not possess any pharmacological properties.

4. The second and third questions are concerned with the type of connection which has exist between the product and its presentation in order for it to be caught by the definition of medicinal product by virtue of its presentation within the meaning of Directive 65/65. In particular, the national court asks whether it is relevant that the therapeutic properties of the product emerge solely from a publication sent on request by the supplier or a third party after the product has been purchased. It also asks whether it is pertinent that the publication in question is made independently of the sale of the product and/or by a third party who is not the supplier or the seller, regard also being had to Article 10 of the European Convention on Human Rights.

5. As for the possibility that the information about the therapeutic or prophylactic properties of a particular product was disclosed by a third party other than the seller or the supplier, I would say forthwith that that circumstance is not in itself conclusive for the purposes of the categorization of the product in question. What is conclusive, however, is whether or not the disclosure of such information was linked, even indirectly, with the producer or supplier of the product in question. The possible existence of any link whatsoever between the author of the publication and/or the person responsible for its distribution and the producer or supplier of the product in question will in fact constitute evidence of an intention to market it (or, rather, to make it appear) as a medicinal product, with the result that the product itself will have to be classed as a medicinal product by virtue of its presentation within the meaning of the first subparagraph of Article 1(2) of Directive 65/65.

6. The national court also refers to Article 10 of the European Convention on Human Rights and asks essentially whether the prohibition on publishing information such as that at issue involves a violation of freedom of expression as enshrined in that article of the Convention.

7. In its fourth question, the national court asks whether it is compatible with the first subparagraph of Article 1(2) of Directive 65/65 that some Member States regard as medicinal products, not only products presented as such within the meaning of that provision, but also foodstuffs which, albeit not possessing any pharmacological properties, are presented by the seller or a third party as having prophylactic or therapeutic properties.

8. In the light of the foregoing considerations, I therefore propose that the Court should answer as follows the questions referred by the Arrondissementsrechtbank, Leeuwarden:

1 Original language: Italian.

2 OJ, English Special Edition 1965-66, p. 20.

3 As from 1 January 1992, that obligation was extended to medicinal products which are not proprietary medicinal products (see Council Directive 89/341/EEC of 3 May 1989, OJ 1989 L 142, p. 11).

4 See, most recently, the judgment in Case C-112/89 Upjohn [1991] ECR I-1703, paragraph 18.

5 Judgment in Case 227/82 Van Bennekom [1983] ECR 3883, paragraph 17; similarly, see, most recently, the judgment in Case C-112/89 Upjohn, cited above, paragraph 16.

6 See the judgment in Van Bennekom, cited above, paragraph 18.

7 See, to that effect, the judgment cited in the preceding footnote, the judgment in Case C-369/88 Delatare [1991] ECR I-1487, paragraphs 40 and 41, and the judgment in Case C-60/89 Monteil and Samanni [1991] ECR I-1547, paragraph 23.

8 See, most recently, the judgment in Case C-260/89 Ellimnkt Radiophonia TUeorassi AE [1991] ECR I-2925, paragraph 41.

9 See the judgment in Ellininki Radiophonia Ttleorassi AE, cited above, paragraph 44.

10 Judgment in Case 35/85 Procureur de la République v Tissier [1986] ECR 1207, paragraph 22.