Opinion of Mr Advocate General
Mr President,
Members of the Court,
1. The questions submitted to this Court for a preliminary ruling by the Tribunal de Grande Instance, Nice, relate to the interpretation of the Community legislation on medicinal products and other Community provisions concerning products (in particular cosmetics and foodstuffs) which may have an impact on health, and to Articles 30 and 36 of the Treaty.
2. Following the complaint by the Conseil National de l'Ordre des Pharmaciens, Mr Delattre, a director of the French company Svensson Tour Pol S.à r. 1. (Svensson), was charged with unlawfully practising the profession of pharmacist on the ground that he had sold certain products which, under the applicable French legislation, are regarded as medicinal products; an authorization is required to place such products on the market and, in addition, they may be sold only through pharmacies.
3. The Juge d'Instruction at the Tribunal de Grande Instance, Nice, therefore submitted four questions for a preliminary ruling, which I think it is reasonable to summarize as follows:
A — General observations
4. The preliminary questions, thus summarized, show clearly that the national court wishes to determine, on the basis of an interpretation by the Court of Justice, whether it is possible to trace a clear borderline between medicinal and other products (be they cosmetics or foodstuffs), a delimitation which, above all, would allow the products at issue to be classified according to Community criteria. Secondly, the national court asks whether, in the absence of a Community classification for the products in question, which would of course result in the reservation in Article 36 being inapplicable, the obligation to obtain prior authorization for the marketing of a product which is classified differently in one or more other Member States is compatible with Article 30 et seq. of the Treaty; and, finally, whether the different extent of the sales monopoly accorded to pharmacists, which is thus separate from the question whether all the Member States classify the same products as medicinal, is justified under Article 36.
5. Directive 65/65, the purpose of which is to remove obstacles to the free movement of medicinal products, is the basic instrument. It represents only the first stage in the harmonization of the national provisions which, although taken further by the second directive referred to earlier, Directive 75/319, is still only partial since, on the one hand, it does not apply to certain categories of medicinal products (for example vaccines, serums, homeopathic proprietary medicinal products and certain others — see Article 34 of the second directive); on the other, it has not yet introduced machinery for Community authorization or for reciprocal recognition of national authorizations.
6. As far as the present case is concerned, it is clear that the following alternative presents itself with respect to the products referred to by the national court: they are either proprietary medicinal products within the meaning of Directive 65/65 and for that very reason their marketing must be subject to prior authorization in all the Member States; or else they do not fall within that concept and therefore, if they are imported, the question arises of the compatibility of prior authorization with Articles 30 and 36 of the Treaty, since the requirement of that authorization appears prima facie to be an obstacle to the free movement of goods.
7. In particular, with regard to the first definition, the difficulty lies precisely in the fact that medicinal products are — obviously — defined by reference to the illness concerned, but the latter term is not itself defined. And the second definition is formulated in such broad terms that, if read literally, it can apply both to medicinal products and to foodstuffs, and also to some cosmetics.
8. With respect to cosmetics, it will be remembered that, pursuant to Article 1 of Directive 76/768, a cosmetic product means any substance or preparation intended for placing in contact with the various external parts of the human body ... or with the teeth and the mucous membranes of the oral cavity with a view exclusively or principally to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours. As is apparent, that is a very precise and detailed definition which, in principle, enables the sector in question to be distinguished from that of medicinal products. None the less, problems may arise regarding products which come not only within that definition but also within that of medicinal products (a circumstance which is liable to arise above all in the case of cosmetics which serve a protective function); in such cases, a useful criterion may be derived from the predominant use and therefore, in some degree, from the view generally held by consumers.
9. More complex is the relationship with the legislation on food products — which of course does not give a Community definition of such products.
10. The same conclusion must be arrived at, in my opinion, in cases not of food products intended for a particular nutritional purpose but of substances normally contained in everyday food products which are intended for nutrition and are considered an essential part of the daily diet and are indispensable for the proper functioning of the body. It is clear that in such cases, as the Court itself stated in Van Bennekom with respect to vitamins, the substances in question cannot be regarded as medicinal products when they are consumed in quantities corresponding to normal requirements and to make up for a deficiency thereof resulting from particular physiological conditions which are not attributable to a pathological abnormality.
B — The questions
11. The first question raises in particular the problem of how to define the term disease or illness. I shall rule out the possibility that there might be a precise and exhaustive Community, and in more general terms a legal, concept of illness, it being a term which is used in numerous Community instruments and doubtless has a similar meaning in all the Member States. Essentially, I do not think we can go far beyond the common meaning of the term and consider pathological conditions of the human organism, which for that very reason require medical treatment and recourse to products which provide a specific remedy. On the other hand, particular physiological conditions, such as mere tiredness (resulting from physical or mental effort) or bad digestion (due to bad eating habits) cannot reasonably — and I refer here to common experience rather than common sense — be regarded intrinsically as illnesses. It seems to me that the question submitted by the national court on this point is almost rhetorical.
12. The second question relates in particular to the concept of medicinal products by virtue of presentation, as defined in the first subparagraph of Article 1(3) of Directive 65/65, pursuant to which Any substance or combination of substances presented for treating or preventing disease in human beings or animals is to be regarded as a medicinal product.
13. In that connection, I would point out that where, as in the present case, a product is not a proprietary medicinal product within the meaning of Directive 65/65, it is clear that the imposition by the national legislature of the requirement of a prior authorization for marketing amounts, in the case of imported products, to a rule capable of hindering intra-Community trade directly or indirectly, actually or potentially, to use the well-known dictum in Dassonville. A further consequence is that, as the Court has also made clear on several occasions, rules which hinder free movement may be justified under Article 36, on grounds of health, only where such rules are proportional and not excessive in relation to the requirement concerned and there are no alternative solutions which would allow the Member States to achieve the same aim with less disturbance of trade.
14. The third question seeks to determine whether, under Community law, the Member States are empowered to create a sales monopoly for pharmacists and if so what the extent of that monopoly is — does it cover only medicinal products as defined in Directive 65/65 or does it extend to medicinal products as defined by each Member State?
15. In the case of the monopoly enjoyed by pharmacies, on the other hand, it is clear that the products in question cannot be marketed otherwise than through pharmacies and the fact that one and the same product may be confined to sales in pharmacies in one Member State and authorized to be sold through other outlets in another Member State together with the fact that, in principle, it is not impossible for one Member State to extend the pharmacists' monopoly to products that are certainly not medicinal products, in itself makes it unacceptable for that Member State not to have to justify such rules under Article 36.
16. In its last question, the national court asks whether the products referred to in Annex I to Directive 74/329 may be subjected to trade restrictions by the Member States.
17. In the light of the foregoing considerations, I therefore propose that the Court give the following answers to the questions referred to it by the Tribunal de Grande Instance, Nice:
1 Original language: Italian,
2 First and second Council Directives (65/65 and 75/319) on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (Official Journal, English Special Edition 1965-1966, p. 20, and OJ 1975 L 147, p. 13).
3 The national court refers in particular to certain provisions of the following directives: Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, p. 169); Council Directive 74/329/EEC of 18 June 1974 on the approximation of the laws of the Member States relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (OJ L 189, p. 1) Council Directive 80/777/EEC of 15 July 1980 on the approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (OJ L 229, p. 1); Council Directive 85/573/EEC of 19 December 1985 which amends Council Directive 77/436/EEC on the approximation of the laws of the Member States relating to coffee extracts and chicory extracts (OJ L 372, p. 22).
4 See Articles L.512, L.596 and L.601 of the Code de la Santé Publique.
5 By virtue of Article L.511 of the Code de Santé Publique, all anti-smoking products are treated as medicinal products.
6 Case 227/82, [1983] ECR 3883.
7 Judgment in Case 35/85 Procureur de la République v Tissier [1986] ECR 1207, paragraph 22
8 See the judgments in Van Bennekom and Tissier, both cited earlier
9 Council Directive on the approximation of the laws of the Member Stales relating to the labelling, presentation and advertising of foodstuffs for sale to the ultimate consumer (OJ 1979 L 33. p 1)
10 OJ 1989 L 186, page 27. That directive replaced Directive 77/94 (OJ 1977 L 26, page 55).
11 Annex I to the directive in question contains a (non-exhaustive) list of groups of products covered by it (including, in fact, food products with low or reduced energy values intended to control weight and foods for diabetics) for which the adoption of directives is envisaged with a view to achieving complete harmonization of the applicable national laws.
12 Supra, paragraph 26
13 Supra, paragraph 29
14 Supra, paragraph 18
15 Ibid, paragraph 17
16 Ibid, paragraph 19
17 The most recent example is Case C-42/90 Bellon [1990] ECR I-4863.
18 See the ludgments in Case 174/82 Sandoz [1983] ECR 2445 and Case 178/84 Commission v Germany [1987] ECR 1227
19 Stipra, paragraph 40
20 Council Directive 85/432 of 15 September 1985 concerning the coordination of provisions laid down by law, regulation or administrative action in respect of certain activities in the field of pharmacy (OJ 1985 L 253, p. 34).
21 Case 8/74, [1974] ECR 837.
22 See in that regard the Opinion of Mr Advocate General Van Gerven of 29 June 1989 in Case C-145/88 ß 6 Q [1989] ECR 3865
23 See to that effect the ludgmcnts in Case 382/87 Buet [1989] ECR 1235 and Case C-145/88 B 6 Q 11989] LCR 3851
24 Judgment in Case 155/80 Oebel [1981] ECR 1993, paragraphs 19 and 20
25 Judgment m Case 75/81 Bleigcn [1982] ECR 1211. paragraph 9
26 Judgment in Case C-23/89 Qmetlynn [ 1990) ECR I-3059