Important legal notice

61989C0060

European Court reports 1991 Page I-01547

Opinion of the Advocate-General

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, (1) 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.

Following a complaint from the Syndicat des Pharmaciens des Bouches-du-Rhône, proceedings were instituted against Mr Samanni for illegally practising the profession of pharmacist on the ground that he had sold, in the self-service shop under his management, modified alcohol of a strength of 70% and eosin of a strength of 2%. Mr Monteil, for his part, was accused of being an accessary since he supplied the products in question to Mr Samanni. The two defendants were found guilty by the Tribunal de Marseilles on 14 June 1988; they appealed to the Cour d' Appel, Aix-en-Provence, which then asked this Court to give a preliminary ruling on the question "whether eosin of a strength of 2% and modified alcohol of a strength of 70% are medicinal products of which the sale is reserved to pharmacists, as defined by European Community law".

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:

(a) whether alcohol and eosin are medicinal products within the meaning of the applicable Community rules; and (b) whether their sale is reserved, under those rules, to pharmacists.

The Community legislation which is relevant to the answer to be given to those questions is, first, Council Directive 65/65/EEC of 26 January 1965 on the approximation of the laws of the Member States relating to proprietary medicinal products (2) and, secondly, Article 30 et seq. of the Treaty, as regards the question whether the creation of a sales monopoly for pharmacists, and in particular the extension of that monopoly to the products at issue, is lawful.

The issue is in fact the same as that already dealt with in Case 369/88 (Delattre), on which I have delivered my Opinion today. I shall therefore refer to that Opinion as regards my general observations and will confine myself here to an analysis relating more specifically to the two products at issue.

It will be remembered that Article 1 of Directive 65/65 defines medicinal products as "Any substance or combination of substances presented for treating or preventing disease in human beings or animals" (medicinal product by virtue of presentation); and it adds that "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 considered a medicinal product (medicinal product by virtue of function).

The directive in question requires the Member States to impose the requirement of a prior marketing authorization only for proprietary medicinal products (Article 3), they being defined as "Any ready-prepared medicinal product placed on the market under a special name and in a special pack".

It follows that, where "proprietary medicinal products" are not involved, the Member States are not under any obligation, but are merely entitled, to require an authorization to be obtained before products are marketed, and, in the case of imported products, that entitlement must be exercised in compliance with Articles 30 and 36 of the Treaty, in so far as a prior authorization represents a barrier to intra-Community trade.

The position having thus been clarified, it is still necessary to decide whether the products at issue fall within the definitions of medicinal products contained in the directive which I quoted earlier, as requested by the national court.

It should be noted first of all that modified alcohol and eosin are both extremely common products that are very widely available, for which the methods of use are indeterminate, and which in any event are well known to all of us, whether or not we have any knowledge of medicine or pharmacy. It is undisputed that alcohol can be used liberally (keeping wastage within the bounds of common sense) to clean the skin and thus prevent infections caused by foreign bodies and impurities, particularly those resulting from abrasions - not to mention the "everyday" use of alcohol for cleaning one' s hands not when they are grazed but when they are very dirty, in other words for general hygiene or as a solvent.

It is similarly well known that eosin is purely and simply a dye ("dawn red", as indicated by the Greek root of the word) used in the manufacture of sweets, red ink, lipstick and nail varnish. Like most dyes, it also has bactericidal properties. Thus, when diluted with water, it is a mild disinfectant which is used instead of alcohol particularly on very delicate grazed skin or where it is preferred to avoid the burning sensation associated with alcohol.

As regards the possible classification of the products in question as medicinal products by virtue of their presentation, I would point out first of all that no details are given in the order for reference concerning their actual presentation. However, it appears from the parties' observations, which were confirmed at the hearing, that neither alcohol nor eosin is indicated or recommended as having properties appropriate for the treatment or prevention of medical conditions. (3)

I also consider that they cannot be implicitly regarded as medicinal products by virtue of their presentation on the basis described by the Court in Van Bennekom: "a product is 'presented for treating or preventing disease ... whenever any averagely well-informed consumer gains the impression, which, provided it is definitive, may even result from implication, that the product in question should, having regard to its presentation, have an effect such as is described by the first part of the Community definition". (4)

I do not in fact consider that an averagely well-informed consumer, even if treated as having no intellectual capacity whatsoever, could attribute to alcohol, and still less to eosin, properties making them suitable for the treatment of a "disease". Whilst it is true that alcohol and eosin are undeniably products with disinfectant properties (and there is no doubt that that is the view generally held by consumers) and are therefore used on the external surface of the body to prevent infections, it is similarly true that they are also used as hygienic products for other purposes. In other words, those possible general applications of the products in question, which have to some extent broadened their functionality, mean that it cannot be said that they are presented as medicinal products by implication.

As regards the concept of medicinal products by virtue of function, it is once again clear, without the need to undertake any analysis, that the products in question are not intended to "restore, correct or modify a physiological function" - which one? If that were not so, then eau de cologne, which has the same disinfectant properties, would also be a medicinal product.

Nor is it inappropriate to draw attention to the fact that, in a memorandum dated 31 May 1988, the Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes of the French Ministère de l' Economie, des Finances et de la Privatisation, expressed its views on the nature of certain "borderline" products, including alcohol and eosin. That memorandum gives general guidance, inter alia, on the criteria to be applied in classifying such products (in the first place, presentation and prevalent use) and in particular, in the case of the products at issue here, it is confirmed that their disinfectant properties are not in any way linked with any pathological condition, that they are products which do not present any risk to health and indeed that they must properly be regarded as hygienic products.

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.

That said, I should also point out that the solution just suggested, namely classification of the product by reference to presentation, is indirectly confirmed by the fact that in several Member States (United Kingdom, Ireland, Belgium and Denmark) the products in question (whose properties are now well known and in respect of which I do not think there can any longer be any divergent scientific assessments) are classified according to their presentation.

It is important to add that the products in question, even when classified as medicinal products by virtue of their presentation (which is not the case here), will only be medicinal products if they are "placed on the market under a special name and in a special pack". The straightforward description as alcohol or eosin or a normal form of packaging, or both, are, as I said earlier, sufficient to show that the products in question are not "proprietary medicinal products" within the meaning of Directive 65/65.

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.

Having regard to the considerations on this matter already put forward in my Opinion in Delattre, and to the foregoing observations, it is apparent, above all, that the Member States are entitled to grant a sales monopoly to pharmacists for alcohol and eosin where they are "proprietary medicinal products". Indeed, I consider that that conclusion applies to the products at issue, since a particular form of packaging and above all a special name may be liable to raise doubts in the mind of the consumer as to the use of those products.

Conversely, where, as in this case, the same products, when imported, are presented only under their common names (for example "alcohol"), I consider that the prohibition on their sales elsewhere than in pharmacies is incompatible with Article 30 and is not objectively justified by reasons of protection of health within the meaning of Article 36.

The products at issue are in fact very safe in use, are easily identifiable by consumers and are widely available for everyday use; accordingly, there is no need for a pharmacist to be present when they are sold.

"As such, modified alcohol of a strength of 70% and eosin of a strength of 2%, not containing other components giving rise to specific therapeutic properties and in any event not specifically presented as medicinal, are not medicinal products within the meaning of Directive 65/65; the extension of the pharmacists' sales monopoly to the products in question, in the case of imports, is incompatible with Article 30 of the Treaty and is not justified by Article 36 where, as in this case, there are no objective requirements of effective protection of health."

(*) Original language: Italian.

(1) Case 215/87 [1989] ECR 617, Opinion at page 629.

(2) OJ, English Special Edition 1965-1966, p. 20.

(3) 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.

(4) Case 227/82 [1983] ECR 3883, paragraph 18.

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