Opinion of Mr Advocate General Tesauro

Mr President,

Members of the Court,

1. The Court is once again called on to intervene in the quarrel between pharmacists and certain traders in France as to whether or not certain products should be classified as medicinal products and as to whether, and if so within what limits, it is lawful to allow them to be sold only by pharmacists. In summarizing the events which gave rise to the present proceedings, I am unable to dispel the suspicion, already expressed in my Opinion in Schumacher, that in disputes of this kind the role of the protagonist is played by Mercury, the god of commerce, rather than by, Hygeia, the goddess of health.

2. If the inappropriate formulation of the preliminary question is disregarded, it is clear from the actual facts of the case that the national court seeks to determine, on the basis of the interpretation given by the Court of Justice:

3. I would then observe that the products at issue, as described by the national court, do not fall within the category of proprietary medicinal products, since they do not have a special name (they are sold under their ordinary international names, alcohol and eosin) and are not presented in a special pack. It is thus obvious that such products, which are not within the scope of Directive 65/65, are not covered by the Member States' obligation to require a prior marketing authorization to be obtained. The lawfulness of such an authorization imposed by a Member State for the products at issue (whether or not they are described as medicinal products) must therefore be appraised, in the case of imported products, in the light of Articles 30 and 36 of the Treaty.

4. The foregoing observations prompt me to conclude that in order to classify the products at issue as medicinal products or otherwise, it is necessary to consider the presentation of the product concerned. Let me explain: products such as those at issue may fall within the Community definition of medicinal product only where they are expressly presented (by indication or recommendation on a label or notice on the package) as disinfectants having therapeutic effects in the treatment of skin infections. Indeed, eosin and alcohol might be marketed with added substances (albeit in minimal amounts) so that they might in fact have therapeutic properties and involve special methods of application or might be capable of harming health. It is clear that in any such case it will be for the national authorities, and possibly the courts, to establish, case by case, whether the presentation typical of medicinal products is merely indicative of speculative intent, in so far as it is intended solely to justify a higher price and more attractive distribution, or of a cautious approach prompted by worthy motives concerned with the health of consumers, which alone justifies a restriction of trade.

5. The second part of the question submitted by the national court seeks to determine whether the granting of a sales monopoly to pharmacists is a matter governed by Community law and, in particular, whether that monopoly extends to the products in question.

6. In view of the foregoing, I conclude by proposing that the Court reply as follows to the question submitted by the Cour d'Appel, Aix-en-Provence:

1 Original Language: Italian.

2 Case 215/87 (1989) ECR 617, Opinion at p. 629.

3 OJ, English Special Edition 1965-1966, p. 20.

4 This is indirectly confirmed, particularly in the case of alcohol, by the abundant national case-law, none of which has defined that product as a medicinal product by virtue of its presentation.

5 Case 227/82 (1983) ECR 3883 Paragraph 18.