Report for the Hearing in Case C-369/88
I — Legal background and facts of the case
A — Legal background
(a) The French legislation on the distribution and advertising of medicinal products
1. The rules on the distribution of medicinal products in France
Article L.511 of the Code de la Santé Publique (Public Health Code) defines medicinal products as any substance or combination of substances presented for treating or preventing disease in human beings or animals and any product which may be administered to humans or animals with a view to making a medical diagnosis or to restoring, correcting or modifying their physiological functions. Medicinal products are to be distinguished, in particular, from cosmetic and bodily hygiene products, which are defined by Article L.658-1 of the same code as all substances or preparations other than medicinal products intended to be brought into contact with various parts of the human body or teeth or mucous membrane, with a view to cleaning them, protecting them, keeping them in good condition, changing their appearance, perfuming them or correcting their odour.
Pursuant to Article L.511, cosmetic products are not to be regarded as medicinal products unless they contain certain substances. The same applies to dietetic products.
Trade in medicinal products is strictly regulated. Under Article L.601 of the Code de la Santé Publique, proprietary medicinal products, namely any ready-prepared medicinal product, presented in a particular packaging and under a special name, may be marketed only after a marketing permit for them has been issued by the Ministre des Affaires Sociales (Minister for Social Affairs).
Pursuant to Article L.512 of the code, the marketing of medicinal products and proprietary medicinal products (as well as the sale of other products such as medicinal products appearing in the pharmacopoeia) may be undertaken only by pharmacists who fulfil the conditions laid down by Article L.514 and must take place in a dispensary, the number of which is limited by Articles L.570 to L.573. Pursuant to Article L.514, a person wishing to practise the profession of pharmacist must satisfy all requirements as to proper professional standards and also (a) hold a pharmacist's diploma and (b) be of French nationality or have the nationality of one of the Member States of the European Economic Community and, finally, (c) be enrolled on the Ordre des Pharmaciens.
Article L.570 et seq. of the Code de la Santé Publique limit the number of dispensaries by reference to population. The general rules are contained in Article L.571, which provides for a dispensary for each 3000 inhabitants in cities of 30000 or more inhabitants, one for each 2500 inhabitants in cities with a population of between 5000 and 30000 inhabitants and one for each 2000 inhabitants in municipalities with a population of fewer than 5000 inhabitants.
Article L.572 lays down different requirements for the départements of Haut-Rhin, Bas-Rhin and Moselle, namely one dispensary for each 5000 inhabitants. Finally, special rules apply to the overseas départements.
Derogations from these statistical rules may, however, be granted if the needs of the population so require (Article L.571).
Article L.596 of the Code de la Santé Publique provides that every establishment involved in the preparation, wholesale sale or distribution of medicinal and other products covered by the pharmacists' monopoly must be owned by a pharmacist or by a company in whose management or overall administration a pharmacist is involved.
Encroachments on the pharmacists' monopoly are penalized under Article L.517 of the Code de la Santé Publique by a fine of FF 3600 to 30000 or imprisonment of six days to six months or both, whereas infringements of Articles L.596 and L.601 of the code are penalized under Article L.518 by a fine of FF 360 to 15000 or imprisonment of six days to three months or both.
2. The French legislation on the advertising of medicinal products
Two provisions must be distinguished.
The conditions for the issue of prior authorizations, laid down by decree of the Conseil d'Etat, are contained in Article R-5045 et seq. of the Code de la Santé Publique.
According to the provisions in force when the events in respect of which proceedings were instituted against Mr Delattre occurred (a new version of which was adopted by a decree of 23 September 1987), advertising of medicinal products was subject to approval by the Minister responsible for health matters on the basis of an opinion from a supervisory committee for advertising under the conditions laid down by Articles R-5047 to R-5052 of the Code de la Santé Publique.
The same system, with a number of adjustments, applied to products other than medicinal products which were presented as being of utility in diagnosing, preventing or treating illness, pursuant to Article R-5052-1 in the version then in force.
Article L.552 of the Code de Santé Publique provides that advertising or publicity, in whatever form, relating to articles, apparatus and methods ... presented as being of use for the diagnosis, prevention or treatment of illness, surgical pathological conditions and physiological disorders, the diagnosis or modification of physical or physiological states or the restoration, correction of modification of organic functions may be prohibited by the competent Minister where it has not been established that such articles, apparatus or methods possess the properties attributed to them.
Under the same provisions, the competent Minister may also make such advertising subject to particular conditions. The measures adopted by the Minister must be based on the opinion of a committee. The conditions for the application of Article L.552 of the Code de Santé Publique are laid down by decree of the Conseil d'Etat and are contained in Articles R-5055 to R-5055-4 of the code.
(b) The Community legislation on medicinal products and on various products which may affect public health
1. Medicinal products and pharmacy
2. Community rules on other products which may have an impact on public health
B — The facts of the case and the questions submitted by the Juge d'Instruction at the Tribunal de Grande Instance, Nice
(A) The facts of the case
Svensson Tour Pol S.à r. I., a company incorporated under French law, whose registered office is at Nice and of which Jean-Marie Delattre is the director, imports and sells by mail order in France products of Belgian origin which are regarded in Belgium either as food supplements or as cosmetic products. The products in question are also distributed in the Benelux countries, Germany, the United Kingdom and Spain.
By order of 9 April 1987, the Minister for Social Affairs and Employment, acting under Article L.552 of the Code de Santé Publique, prohibited that company from advertising four of the products sold by it: the Zéro 3 slimming method, the Pak-Heat heat-emitting dressing, the Boddy Choc body wrap and the Taiki dressing on the ground that there was no scientific evidence to show that those products actually had the properties attributed to them.
However, the Conseil National de l'Ordre des Pharmaciens had already, on 18 November 1986, lodged a complaint before the Tribunal de Grande Instance (Regional Court), Nice, claiming damages as a civil party, on the ground that the company had infringed Articles L.512, L.596 and L.601 of the code in so far as various products distributed by it were in the nature of medicinal products and therefore could be marketed only under the conditions laid down in those provisions — that is to say, in particular, after authorization to place them on the market had been obtained and subject to the pharmacists' monopoly.
The complaint refers to a total of 11 products, comprising 4 slimming products (Slim 4, Zéro 3 and persimmon tea, Kilomin, and Chlorella), a product presented as facilitating digestion, garlic oil extract, two products presented as stimulating blood circulation and therefore as having properties for the relief of tiredness (a herb for treatment of the legs and a tiredness-relieving gel for the legs), an anti-itching product (M27), an anti-fatigue product (wheat-germ oil + vitamin E), a product for the joints (Mineral 23) and a method for stopping smoking (Turn-off, presented in the form of herbal tablets together with a cigarette-holder with an adjustable smoke filter).
According to Svensson, eight of those products are classified in Belgium as foodstuffs, two (M27 and leg gel) as cosmetic products, while Turn-off is an anti-tobacco product.
Mr Delattre claimed before the Juge d'Instruction that it would be contrary to Community law, in particular the rules on the free movement of goods, for the various products in question to be made subject to the conditions applicable to medicinal products, as claimed by the Conseil National de l'Ordre des Pharmaciens, since that would entail obtaining a marketing authorization and distribution solely through pharmacies, and therefore the Juge d'Instruction at the Nice court referred the following questions to the Court of Justice for a preliminary ruling:
1. (i) Should the terms disease or illness as used in the abovementioned directives be interpreted uniformly in accordance with a Community definition, or is each Member State at liberty to implement the abovementioned directives by giving its own definition of them? (ii) If the terms disease and illness have a Community meaning, can product A, which is designated as a food product in one Member State and whose advertisements refer to natural physiological functions (digestion, elimination of bile), be designated as a medicinal product in another Member State although a Community directive harmonizing the rules applicable to product B (natural mineral waters, Directive 80/777/EEC) states expressly that those natural physiological functions must not be regarded as illnesses? (iii) If the terms disease and illness have a Community definition, can references to sensations or states such as hunger, heaviness in the legs, tiredness and/or itching (a sensation felt on the skin giving rise to an urge to scratch) be regarded as references to diseases or illnesses. (iv) If, however, each Member State is at liberty to determine its own definition of illness may a Member State freely block the sale of a food product which is lawfully controlled and freely sold in another Member State on the ground that the said product is for a human illness or disease (according to the meaning given to that concept by the Member State) without first having requested the opinion of the committees set up to ensure that national provisions do not conflict among themselves or with Community law, in particular the opinion of the Committee for Proprietary Medicinal Products (established by Directive 75/319/EEC), the Standing Committee for Foodstuffs (Decision 69/414/EEC), the Committee for Cosmetic Products (Directive 76/768/EEC) and/or the Standing Committee on Technical Standards and Regulations (Directives 83/189/EEC and 88/182/EEC)?
2. (i) Having regard to the judgment in Case 227/82 Van Bennekom [1983] ECR 3883, in particular paragraph 19, may a Member State restrict the free importation and marketing of a food product extracted from a plant in common consumption (garlic), lawfully manufactured, controlled and sold in another Member State, on the ground that the external form of the product (pill, capsule, tablet) is medicinal although that same external form is permitted by Community Law (Directive 85/573/EEC) for another product which is also extracted from a plant in common consumption (chicory)? (ii) If the answer to the above question is in the affirmative, can a national provision of that type be justified with regard to Community law (in particular Article 36) and the case-law of the Court of Justice if those plants are presented in the form of a pill, capsule or tablet solely for reasons of hygiene and preservation and the product concerned (a) has no, and is not presented as having, curative or preventive properties with regard to human illness and is even packed in a container on which it is expressly stated that this is not a medicinal product, (b) contains no constituent in such a high concentration that it constitutes a medicinal product and (c) does not constitute a serious (scientifically determinable) public health hazard?
3. (i) Does the pharmacists legal monopoly of the right to sell certain products to the public fall under the commercial rules of the Member States? (ii) If the reply to question 3(i) is in the affirmative, does the statement contained in Directive 85/342 concerning the monopoly of the supply of medicinal products refer to a medicinal product as defined by Directive 65/65/EEC or to medicinal products as defined by each Member State? (iii) If the Community definition of medicinal product applies in Question 3(ii), can a monopoly of the supply of medicinal products be regarded as a measure having an effect equivalent to a quantitative restriction on the importation of a product if the result of that monopoly is to prevent the free marketing of that product even though it is (a) classified as a food product in the Member State in which it is manufactured, (b) subject to control by the competent authority {the Belgian Ministry of Health) of that same Member State, which certifies it as harmless to human health, and (c) sold freely to the public (that is to say, without a doctor's prescription) solely by pharmacists in pharmacies in the importing State? (iv) If the reply to Question 3(iii) is in the affirmative, does such a legal monopoly of the free supply (that is to say, without a doctor's prescription) of certain products to individuals need to be justified under Article 36 of the EEC Treaty, and in particular must it be justified as a protection against a real threat to human health (Case 216/84 Commission v French Republic (milk substitutes) [1988] ECR 793). Conversely, should the preamble and the text of the abovementioned Directive 85/432 be interpreted as meaning that a Member State may lawfully designate any product as a medicinal product and adopt any measures restrictive of competition in respect of that product, including granting to pharmacists in pharmacies the exclusive right of free sale (that is to say, without a doctor's prescription) of that product to the public?
4. (i) Should the provisions of Council Directive 74/329/EEC on the approximation of laws of the Member States on emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs, in particular the provisions in its preamble on the free circulation of foodstuffs and the provisions of Article 2, be interpreted as prohibiting a Member State from imposing restrictions (for example, a requirement that administrative authorization for placing it on the market be obtained) on the free marketing (and free movement) of the products (such as guar gum in particular) specifically referred to in Annex 1 to that directive? (ii) If the answer to Question 4(i) is in the negative, should not Community law be interpreted as requiring that in any event a decision by the authorities of a Member State imposing restrictions (for example, a requirement that administrative authorization for placing it on the market be obtained) on the free marketing (and free movement) of the products specifically referred to in Annex 1 to that directive should be accompanied by a general statement of reasons or be justified under Article 36 of the Treaty of Rome and that it should not constitute an arbitrary or disguised means of infringing Community law?
The order for reference was received at the Court Registry on 19 December 1988.
Pursuant to Article 20 of the Protocol on the Statute of the Court of Justice of the EEC, written observations were submitted by Mr Delaure, represented by André Moquet and Eric Morgan de Rivery, of the Paris Bar, by the French Government, represented by Edwige Belliard, assisted by Sylvie Grassi, acting as Agents, by the Italian Government, represented by Pier Giorgio Ferri, Avvocato dello Stato, acting as Agent, by the Commission of the European Communities, represented by Richard Wainwright, Legal Adviser to the Commission, and Blanca Rodríguez Galindo, a member of the Commission's Legal Department, acting as Agents.
Upon hearing the report of the Judge-Rapporteur and the views of the Advocate General, the Court decided to open the oral procedure without any preparatory inquiry.
By decision of 4 July 1990, the Court assigned the case to the Fifth Chamber.
II — Summary of the written observations submitted to the Court
A — The general observations submitted by Mr Deiattre and the Commission
Mr Delattre's general observations concern the dispute in the main proceedings in relation to Community law and the classification of the products at issue under Community law.
According to Jean-Marie Deiattre, the principle of the free movement of goods is the central focus of the four questions submitted. In his view, the matter at issue is the application of Article 30 of the EEC Treaty, which prohibits quantitative restrictions on imports and all measures having equivalent effect. He states that in the business sectors in which laws have been harmonized the Member States may no longer adopt restrictive measures. Such harmonization has been carried out, at least partially, in the sectors of cosmetic products and foodstuffs.
Where no harmonization measures have been adopted, only three types of measure may be taken by the Member States, according to the defendant in the main proceedings. These may be measures directed specifically against imports or measures which, although ostensibly general, are inimical above all to imports. Such measures must be justified under Article 36 of the EEC Treaty. In the case of measures which apply without distinction to national and imported products, Commission Directive 70/50/EEC of 22 December 1969 (Official Journal, English Special Edition 1970 (I), p. 17) requires them to pursue a legitimate objective and to be proportionate to that objective, a rule confirmed by the Court of Justice in its judgment in Case 120/78 Rewe-Zentrale v Bundesmonopolverwaltung fiir Branntwein [1979] ECR 649.
Mr Deiattre considers that although the action brought against him appears to be based on measures which apply without distinction to national and imported products, it is in fact discriminatory since it penalizes a method of marketing — sale to the general public by mail order — which is used mainly by importers. He points out that, for a considerable period, products similar to those of Svensson have been marketed in France in specialized shops and that he has drawn the attention of the trial court to two examples of networks comprising numerous specialized shops: the La Vie Claire network and the Vitamin System network, which sell products that are in every respect comparable with Svensson products without ever having attracted the attention of the authorities. There is thus discrimination which may hinder the sale on the French market of imported products in view of the fact that mail order companies and department stores would be prosecuted even though sales by another method would not arouse any objection.
As regards the nature of the products distributed by Svensson, they are, according to the defendant in the main proceedings, described in Belgium either as foodstuffs or as bodily hygiene products, with the exception of the product Turn-off, which is an anti-tobacco product. Those classifications were confirmed by judgment of the Cour d'Appel, Ghent, of 13 October 1987.
In the case of the products classified as cosmetic products, free movement is ensured by virtue of Council Directive 76/768 mentioned above. Provided that the products in question meet the requirements of the directive, they must be able to move freely. In this case, that applies to the two products M27 and leg gel.
As regards foodstuffs, although the harmonization of the rules applicable to them is not complete, various pieces of Community legislation, such as Directive 79/112, Directive 80/777 on mineral waters and Directive 77/436 on chicory, make it possible to define them precisely and distinguish them from medicinal products.
It is apparent from a comparison of those instruments with Directive 65/65 on the approximation of the laws of the Member States relating to proprietary medicinal products that a product is to be regarded as a medicinal product if it purports to be suitable for treating, curing or preventing disease in human beings or if it is intended to be administered to human beings with a view to making a medical diagnosis or restoring, correcting or modifying physiological functions.
Finally, the product Turn-off, an ordinary anti-smoking product, is not a medicinal product under Community law, even if French law provides otherwise.
(b) The general observations of the Commission
The Commission states in the first place that Directive 65/65 on the approximation of the laws of the Member States relating to proprietary medicinal products is intended solely to make medicinal products, as defined by it, subject to a system of authorizations for placing products on the market. Neither that directive nor those by which it has been amended in any way prejudge the system for the distribution of medicinal products to be adopted by the Member States or, in particular, have any impact on any monopoly which may be granted to pharmacists for the distribution of medicinal products.
Furthermore, it is for the national authorities to classify the various products according to the definitional basis provided by the directive. The French system for the distribution of medicinal products does not seem to the Commission to clearly constitute a measure having an effect equivalent to a quantitative restriction on imports, since the system is not discriminatory. In any event, restrictive rules concerning the distribution of medicinal products may be justified by the requirement of protecting public health.
B — The various observations submitted on the preliminary questions
(a) The first question
1. Observations of Mr Delattre
The Commission considers that the first preliminary question must be placed in the context of the definition of medicinal products. From that standpoint, the concept of disease is not defined in Community legislation, even though certain instruments refer to it, for example Article l(l)(c) of Council Directive 75/363/EEC of 16 June 1975 concerning the coordination of provisions laid down by law, regulation or administrative action in respect of activities of doctors (Official Journal 1975 L 167, p. 14).
The Commission considers that in those circumstances, although a Member State may not be bound by a legal definition of disease at Community level, it is subject to limitations by virtue of the scientific and medical character of the definition, which necessarily means that there must be an equivalent, if not uniform, concept of disease in all the Member States.
It is necessary to apply that equivalent concept case by case in order to decide on the classification of the products at issue in the main proceedings.
As regards the various Community committees referred to by the national court, it is not their function to place the various products in such categories as might be appropriate. Their role is purely advisory.
According to the French Government, the Conseil National de l'Ordre des Pharmaciens, which made the original complaint against Mr Delattre, considers that the products distributed by Svensson are medicinal products by virtue of their presentation, as defined in the first subparagraph of Article 1(2) of Directive 65/65.
Article 1 of that directive and Article L.511 of the Code de Santé Publique give two definitions of proprietary medicinal products based on two different logical approaches. A product may be a medicinal product by virtue of its function provided that it facilitates diagnosis or can affect physiological functions. But a product may also be a medicinal product merely because it is presented as having curative properties, such a definition being a means of combating charlatanry.
The French Government considers that the various products distributed by Svensson are medicinal products either by virtue of their function or, more often, by virtue of their presentation. It also considers that the statement that the various products are not medicinal products, appearing on their packaging, is not in itself sufficient to remove them from the scope of the legislation on the distribution of medicinal products.
Moreover, the mere fact that that statement is made shows that those products are presented in such a way as to cause consumers to have doubts. The French Government considers, however, that since harmonization in that area is not complete, the appraisal of the risk to public health may vary from one Member State to another, so that a product might be classified as a medicinal product in one country and not in another or others.
According to the Belgian Government, the concept of medicinal product extends beyond that of treatment of a disease in the strict sense.
It is not sufficient to make no reference to specific diseases for a product to cease to be classified as a medicinal product, and at the same time it is not necessary for a product actually to have the properties attributed to it for it to be subject to the provisions applicable to medicinal products.
It is sufficient for a product to be manufactured and intended for use by a reasonably well-informed consumer by reason of the specific properties attributed to it and not mainly for its food value or taste.
The fact that Directive 80/777 on mineral waters allows such effects on health to be indicated does not mean that such indications are generally permissible for other products. Accordingly, a product which is at the outset a foodstuff but has been prepared in a special way and whose external presentation is similar to that of a medicinal product, and is offered for sale for use by consumers not for its food value but especially because of its real or supposed effects on health, ought to be subject to the rules applicable to medicinal products.
According to the Italian Government, the term disease is not defined by Directive 65/65 and such a definition is not needed. Directive 65/65 relies on factors other than the concept of disease in order to define medicinal products. Furthermore, it should be borne in mind that although Directive 80/777 on mineral waters allows the use with respect to them of statements such as stimulates digestion or may facilitate the hepato-biliary functions, those statements are authorized by way of derogation from the prohibition laid down in Article 9(2)(a) of that directive on the attribution to a natural mineral water of properties relating to the prevention, treatment or care of a human illness.
It follows that in the absence of an express derogation, such statements would have to be regarded as attributing to the product concerned properties relating to the prevention, treatment or care of a human illness.
On the other hand, Directive 85/573 on chicory extracts does not appear relevant to the Italian Government, which points out that according to the case-law of the Court, in particular the judgment in Case 227/82 Van Bennekon, supra, account may be taken, in classifying a product as a medicinal product, not only of its presentation but also of other criteria. In its view, finally, it is clear that, in the case of garlic tablets, the producer in this case intended, through the presentation of the product, that it should be used for therapeutic purposes.
(b) The second question
1. Mr Delattre states that, according to the case-law of the Court, in particular the judgment in Case 227/82 Van Bennekon, supra, the external form of a product is not the sole and decisive criterion for classifying a product as a medicinal product. That decision reflects the true position since natural food supplements are traditionally presented in the form of tablets, pills or capsules.
2. According to the Commission, the second question submitted by the national court concerns products which are medicinal by virtue of their presentation, and guidance in that regard is to be found in the Van Bennekom judgment, supra. It appears from that judgment that whilst the concept of presentation must be interpreted extensively, the external form given to the product is not the sole or decisive criterion; otherwise products traditionally presented in forms similar to those of proprietary medicinal products might be brought within the scope of the term medicinal products. That would apply, for example, to chicory, a good product usually presented in the form of tablets, and account of that is taken by Directive 77/436 on the approximation of the laws of the Member States relating to coffee extracts and chicory extracts.
3. The French Government also considers that the garlic pills distributed by Svensson must be regarded as medicinal products by virtue of their presentation, a view which is also expressed by the Italian Government.
(c) The third question
1. According to Mr Delattre, in the absence of relevant legislation the pharmacists' legal monopoly over the sale of certain products to the public falls within the scope of the power granted by the Treaty to the Member States to adopt trade legislation. He considers, however, having regard to the case-law of the Court, that such legislation which makes a specific channel of distribution compulsory constitutes a measure having an effect equivalent to a quantitative restriction. Such a restriction cannot be regarded as justified where it applies to products whose use does not call for advice from a pharmacist, as the Commission pointed out in a reply to a written question submitted by Mr Patterson (No 1795/87, Official Journal C 244 of 19.9.1988, p. 16) with respect to artificial sweeteners, the sale of which is reserved by French law to pharmacists.
2. According to the Commission, the institution of a monopoly for pharmacists falls within the powers of the Member States, as indeed is expressly recognized in the second recital in the preamble to Directive 85/432.
3. The French Government, which considers that sale exclusively through pharmacies is not in itself a handicap to marketing since there are 22000 sales outlets, points out that since harmonization is not complete in the field of medicinal products the risk to public health associated with a product may be assessed differently from one Member State to another. It follows that Article 30 et seq. of the Treaty may be applicable.
4. According to the Belgian Government, the institution of a monopoly for pharmacists is a matter within the powers of the Member States, as is made clear in the second recital in the preamble to Directive 85/432. Moreover, for a medicinal to be able to be marketed in a Member State, a marketing authorization must have been obtained and consequently the fact that it is lawfully manufactured and marketed in another Member State is not sufficient.
(d) The fourth question
1. Mr Delattre states that this question is concerned only the product Zéro 3, which is made of guar gum. The matter at issue is the scope of 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 (Official Journal 1974 L 189, p. 1). Mr Delattre points out in the first place that guar gum is a substance recognized as harmless by the international scientific community.
2. The Commission states that the question concerns the scope of Directive 74/329. The sole purpose of that directive is to harmonize the laws of the Member States on the use of emulsifiers, stabilizers, thickeners and gelling agents when they are used as such, that is to say in foodstuffs.
3. According to the French Government, the product Zéro 3 is presented as a medicinal product and its use involves risks to public health.
1 Language of the case: French.