C-60/89
ECLI:EU:C:1991:18
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OPINION OF MR TESAURO — CASE C-6O/89
OPINION OF MR ADVOCATE GENERAL TESAURO delivered on 16 J a n u a r y 1991 *
Mr President, question 'whether eosin of a strength of 2 % Members of the Court, 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'.
1. The Court is once again called on to intervene in the 'quarrel' between phar- macists and certain traders in France as to 2. If the inappropriate formulation of the whether or not certain products should be preliminary question is disregarded, it is classified as medicinal products and as to clear from the actual facts of the case that whether, and if so within what limits, it is the national court seeks to determine, on lawful to allow them to be sold only by the basis of the interpretation given by the pharmacists. In summarizing the events Court of Justice: 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 (a) whether alcohol and eosin are medicinal of commerce, rather than by, Hygeia, the products within the meaning of the goddess of health. applicable Community rules; and
(b) whether their sale is reserved, under Following a complaint from the Syndicat those rules, to pharmacists. 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 The Community legislation which is his management, modified alcohol of a relevant to the answer to be given to those strength of 70% and eosin of a strength of questions is, first, Council Directive 2 % . Mr Monteil, for his part, was accused 65/65/EEC of 26 January 1965 on the of being an accessary since he supplied the approximation of the laws of the Member products in question to Mr Samanni. The States relating to proprietary medicinal two defendants were found guilty by the products 2and, secondly, Article 30 et seq. Tribunal de Marseilles on 14 June 1988; of the Treaty, as regards the question they appealed to the Cour d'Appel, whether the creation of a sales monopoly Aix-en-Provence, which then asked this for pharmacists, and in particular the Court to give a preliminary ruling on the extension of that monopoly to the products at issue, is lawful. * Original Language: Italian. 1 — Case 215/87 (1989) ECR 617, Opinion at p. 629. 2 — OJ, English Special Edition 1965-1966, p. 20.
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MONTEIL AND SAMANNI
The issue is in fact the same as that already Treaty, in so far as a prior authorization dealt with in Case 369/88 Delattre [1991] represents a barrier to intra-Community ECR I-1487, I-1508, on which I have trade. 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. 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 It will be remembered that Article 1 of ordinary international names, 'alcohol' and Directive 65/65 defines medicinal products 'eosin') and are not presented in a special as 'Any substance or combination of pack. It is thus obvious that such products, substances presented for treating or which are not within the scope of Directive preventing disease in human beings or 65/65, are not covered by the Member animals' (medicinal product by virtue of States' obligation to require a prior presentation); and it adds that 'Any marketing authorization to be obtained. The substance or combination of substances lawfulness of such an authorization imposed which may be administered to human beings by a Member State for the products at issue or animals with a view to making a medical (whether or not they are described as diagnosis or to restoring, correcting or medicinal products) must therefore be modifying physiological functions in human appraised, in the case of imported products, beings or in animals' is likewise considered a in the light of Articles 30 and 36 of the medicinal product (medicinal product by Treaty. virtue of function).
The position having thus been clarified, it is The directive in question requires the still necessary to decide whether the Member States to impose the requirement products at issue fall within the definitions of a prior marketing authorization only for of medicinal products contained in the proprietary medicinal products (Article 3), directive which I quoted earlier, as they being defined as 'Any ready-prepared requested by the national court. medicinal product placed on the market under a special name and in a special pack'.
It should be noted first of all that modified alcohol and eosin are both extremely It follows that, where 'proprietary medicinal common products that are very widely products' are not involved, the Member available, for which the methods of use are States are not under any obligation, but are indeterminate, and which in any event are merely entitled, to require an authorization well known to all of us, whether or not we to be obtained before products are have any knowledge of medicine or marketed, and, in the case of imported pharmacy. It is undisputed that alcohol can products, that entitlement must be exercised be used liberally (keeping wastage within in compliance with Articles 30 and 36 of the the bounds of common sense) to clean the
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OPINION OF MR TESAURO — CASE C-60/89
skin and thus prevent infections caused by the Court in Van Bennekom: 'a product is foreign bodies and impurities, particularly presented for treating or preventing those resulting from abrasions — not to disease . . . whenever any averagely well- mention the 'everyday' use of alcohol for informed consumer gains the impression, cleaning one's hands not when they are which, provided it is definitive, may even grazed but when they are very dirty, in result from implication, that the product in other words for general hygiene or as a question should, having regard to its presen- solvent. tation, have an effect such as is described by the first part of the Community definition'. 4
It is similarly well known that eosin is purely and simply a dye ('dawn red', as indicated by the Greek root of the word) I do not in fact consider that an averagely used in the manufacture of sweets, red ink, well-informed consumer, even if treated as lipstick and nail varnish. Like most dyes, it having no intellectual capacity whatsoever, also has bactericidal properties. Thus, when could attribute to alcohol, and still less to diluted with water, it is a mild disinfectant eosin, properties making them suitable for which is used instead of alcohol particularly the treatment of a 'disease'. Whilst it is true on very delicate grazed skin or where it is that alcohol and eosin are undeniably preferred to avoid the burning sensation products with disinfectant properties (and associated with alcohol. 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 As regards the possible classification of the products for other purposes. In other words, products in question as medicinal products those possible general applications of the by virtue of their presentation, I would products in question, which have to some point out first of all that no details are given extent broadened their functionality, mean in the order for reference concerning their that it cannot be said that they are presented actual presentation. However, it appears as medicinal products by implication. from the parties' observations, which were confirmed at the hearing, that neither alcohol nor eosin is indicated or recom- mended as having properties appropriate for the treatment or prevention of medical conditions. 3 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 I also consider that they cannot be implicitly modify a physiological function' — which regarded as medicinal products by virtue of one? If that were not so, then eau de their presentation on the basis described by cologne, which has the same disinfectant properties, would also be a medicinal 3 — This is indirectly confirmed, particularly in the case of product. 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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MONTEIL AND SAMANNI
Nor is it inappropriate to draw attention to a cautious approach prompted by worthy the fact that, in a memorandum dated motives concerned with the health of 31 May 1988, the Direction Générale de la consumers, which alone justifies a restriction Concurrence, de la Consommation et de la of trade. 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 memo- randum gives general guidance, inter alia, on the criteria to be applied in classifying That said, I should also point out that the such products (in the first place, presen- solution just suggested, namely classification tation and prevalent use) and in particular, of the product by reference to presentation, in the case of the products at issue here, it is is indirectly confirmed by the fact that in confirmed that their disinfectant properties several Member States (United Kingdom, are not in any way linked with any patho- Ireland, Belgium and Denmark) the logical condition, that they are products products in question (whose properties are which do not present any risk to health and now well known and in respect of which I indeed that they must properly be regarded do not think there can any longer be any as hygienic products. divergent scientific assessments) are classified according to their presentation.
4. The foregoing observations prompt me to conclude that in order to classify the It is important to add that the products in products at issue as medicinal products or question, even when classified as medicinal otherwise, it is necessary to consider the products by virtue of their presentation presentation of the product concerned. Let (which is not the case here), will only be me explain: products such as those at issue medicinal products if they are 'placed on the may fall within the Community definition of market under a special name and in a medicinal product only where they are special pack'. The straightforward expressly presented (by indication or recom- description as alcohol or eosin or a normal mendation on a label or notice on the form of packaging, or both, are, as I said package) as disinfectants having therapeutic earlier, sufficient to show that the products effects in the treatment of skin infections. in question are not 'proprietary medicinal Indeed, eosin and alcohol might be products' within the meaning of Directive marketed with added substances (albeit in 65/65. 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 presen- 5. The second part of the question tation typical of medicinal products is submitted by the national court seeks to merely indicative of speculative intent, in so determine whether the granting of a sales far as it is intended solely to justify a higher monopoly to pharmacists is a matter price and more attractive distribution, or of governed by Community law and, in
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OPINION OF MR TESAURO — CASE C-60/89
particular, whether that monopoly extends Conversely, where, as in this case, the same to the products in question. products, when imported, are presented only under their common names (for Having regard to the considerations on this example 'alcohol'), I consider that the matter already put forward in my Opinion prohibition on their sales elsewhere than in in Delattre, and to the foregoing obser- pharmacies is incompatible with Article 30 vations, it is apparent, above all, that the and is not objectively justified by reasons of Member States are entitled to grant a sales protection of health within the meaning of monopoly to pharmacists for alcohol and Article 36. eosin where they are 'proprietary medicinal products'. Indeed, I consider that that conclusion applies to the products at issue, The products at issue are in fact very safe in since a particular form of packaging and use, are easily identifiable by consumers and above all a special name may be liable to are widely available for everyday use; raise doubts in the mind of the consumer as accordingly, there is no need for a phar- to the use of those products. macist to be present when they are sold.
6. In view of the foregoing, I conclude by proposing that the C o u r t reply as follows to the question submitted by the C o u r d'Appel, Aix-en-Provence:
'As such, modified alcohol of a strength of 7 0 % 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 6 5 / 6 5 ; the extension of the pharmacists' sales monopoly to the products in question, in the case of imports, is incompatible with Article 30 of the T r e a t y and is not justified by Article 36 where, as in this case, there are no objective requirements of effective protection of health.'
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