61988J0369

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1. Approximation of laws - Proprietary medicinal products - Directive 65/65 - Concept of disease or illness - No definition

(Council Directive 65/65)

2. Approximation of laws - Proprietary medicinal products - Product fulfilling both the definition of medicinal product given in Directive 65/65 and that of cosmetic product given in Directive 76/768 - Covered by Directive 65/65

(Council Directive 65/65, Art. 1(2), and Council Directive 76/768, Art. 1(1))

3. Approximation of laws - Proprietary medicinal products - Definition of medicinal products given in Directive 65/65 - Medicinal products by virtue of their function and medicinal products by virtue of their presentation - Application by the national authorities to a product presented for dealing with certain sensations or states - Criteria

(Council Directive 65/65, Art. 1(2))

4. Free movement of goods - Quantitative restrictions - Measures having equivalent effect - Pharmacists' monopoly - Extent - Medicinal products within the meaning of Directive 65/65 - Presumption of justification - Other products - Justification - Protection of public health or of consumers - Examination by national court

(EEC Treaty, Arts 30 and 36; Council Directive 65/65)

5. Approximation of laws - Emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs - Directive 74/329 - Scope - Inclusion in the pharmacists' monopoly of a product listed in Annex I but used for a purpose not covered by the directive - Excluded - Application of Articles 30 and 36 of the Treaty

(EEC Treaty, Arts 30 and 36; Council Directives 65/65 and 74/329)

1. Council Directive 65/65 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products gives no definition of illness or disease. The only possible definitions for those terms are those most commonly accepted on the basis of scientific knowledge.

2. A given product, even if it falls within the definition of cosmetic products given in Article 1(1) of Directive 76/768, must nevertheless be treated as a "medicinal product" referred to in Article 1(2) of Directive 65/65 on proprietary medicinal products and be made subject to the corresponding rules if it is presented as possessing properties for the treatment or prevention of illness or disease or if it is intended to be administered with a view to restoring, correcting or modifying physiological functions.

That classification is necessary in view of the aim of protecting public health pursued by both directives, since the legal rules applicable to proprietary medicinal products are more rigorous than those applicable to cosmetic products, in view of the particular dangers which the former may present to public health and cosmetic products generally do not.

3. A product presented as being intended to facilitate certain physiological functions falls within the scope of the Community definition of medicinal product in the second subparagraph of Article 1(2) of Council Directive 65/65/EEC as a medicinal product by virtue of its function. In order to decide whether that product is to be categorized as a medicinal product or as a foodstuff, it is necessary to have regard to its pharmacological properties. The fact that such a product is classified as a foodstuff in one Member State does not preclude its being treated as a medicinal product in the State concerned if it possesses the relevant characteristics. The specific features of the legislation concerning natural mineral waters have no relevance to the definition of medicinal product within the meaning of Directive 65/65/EEC.

A product may be regarded as being a medicinal product "by virtue of its presentation" for the purposes of the first subparagraph of Article 1(2) of Directive 65/65 if its form and the manner in which it is packaged render it sufficiently similar to a medicinal product and, in particular, if on its packing and in the information provided with it reference is made to research by pharmaceutical laboratories, to methods or substances developed by medical practitioners or even to testimonials from medical practitioners commending the qualities of the product. A statement that the product is not medicinal is persuasive evidence which the national court may take into consideration but is not in itself conclusive.

It is for the national authorities to determine, subject to judicial review, whether or not, having regard to its composition, the risks which its prolonged consumption may entail or its side-effects and, more generally, all of its characteristics, a product presented as counteracting certain conditions or sensations, such as hunger, heaviness in the legs, tiredness or itching constitutes a medicinal product.

There is no provision obliging Member States to consult the consultative committees specialized in medicinal products attached to the Community institutions before taking the steps dictated in internal law by the definitions of medicinal product given in Directive 65/65/EEC.

4. Under Community law as it now stands, the determination of the rules governing the distribution of pharmaceutical products remains a matter for the Member States, provided that the provisions of the Treaty, and in particular those relating to the free movement of goods, are respected.

A monopoly of the right to distribute medicinal or other products, granted to dispensing pharmacists, may constitute a barrier to importation.

If a Member State chooses to restrict to pharmacists the right to distribute products of that kind, such a barrier is, in principle and in the absence of any evidence to the contrary, justified in so far as it concerns medicinal products within the meaning of Council Directive 65/65/EEC on proprietary medicinal products.

Where other products are concerned, however they may be classified in national law, it is for the national court to determine whether a monopoly of the right to market such products granted to pharmacists is necessary for the protection of public health or of consumers and whether those two aims cannot be achieved by measures less restrictive of intra-Community trade.

5. Directive 74/329 on the approximation of the laws of the Member States on emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (Official Journal 1974 L 189, p. 1) and Articles 30 and 36 of the EEC Treaty must be interpreted as meaning that a measure whereby a Member State makes a product listed in Annex I to the directive, such as guar gum, subject to marketing authorization and to the sales monopoly of pharmacists when it is used as part of a method intended to facilitate weight loss, however that product may be classified in any other sphere of national law, does not fall within the scope of that directive, but may constitute a barrier to importation. When the product in issue is not a medicinal product within the meaning of Directive 65/65/EEC on proprietary medicinal products, such a measure is not permissible under Community law unless it is necessary in order to protect public health or consumers and is proportionate to those aims.

In Case C-369/88,

REFERENCE to the Court under Article 177 of the EEC Treaty by the Tribunal de Grande Instance (Regional Court), Nice, France, for a preliminary ruling in the criminal proceedings pending before that court against

Jean-Marie Delattre, Saint-Vaast, Belgium,

on the interpretation of the provisions of Community law relating to the concepts of illness or disease and medicinal products, of Articles 30 and 36 of the Treaty in relation to the sales monopoly granted to pharmacists in respect of certain products and 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 (Official Journal 1974 L 189, p. 1),

THE COURT (Fifth Chamber),

composed of J. C. Moitinho de Almeida, President of the Chamber, G. C. Rodríguez Iglesias, Sir Gordon Slynn, F. Grévisse and M. Zuleeg, Judges,

Advocate General: G. Tesauro,

Registrar: H. A. Ruehl, Principal Administrator,

after considering the observations submitted on behalf of

Mr Delattre, by André Moquet and Eric Morgan de Rivery, of the Paris Bar,

the French Government, by Edwige Belliard, Assistant Director, Legal Affairs Directorate , Ministry of Foreign Affairs, assisted by Sylvie Grassi, Secretary for Foreign Affairs, Ministry of Foreign Affairs, acting as Agents,

the Italian Government, by Pier Giorgio Ferri, Avvocato dello Stato, acting as Agent,

the Commission of the European Communities, by Richard Wainwright, Legal Adviser, and Blanca Rodríguez Galindo, a member of the Commission' s Legal Department, acting as Agents,

having regard to the Report for the Hearing,

after hearing oral argument presented on behalf of Mr Delattre, the French Government, represented by Hélène Duchène, Secretary for Foreign Affairs, Ministry of Foreign Affairs, acting as Agent, the Italian Government, and the Commission, represented by Hervé Lehman, a French civil servant seconded to the Commission' s Legal Department, acting as Agent, at the sitting on 24 October 1990,

After hearing the Opinion of the Advocate General delivered at the sitting on 16 January 1991,

gives the following

Judgment

1 By order of 12 December 1988, which was received at the Court Registry on 19 December 1988, the Juge d' Instruction at the Tribunal de Grande Instance, Nice, referred to the Court for a preliminary ruling under Article 177 of the EEC Treaty several questions on the concepts of illness or disease and medicinal products and their definition in Community law, on the compatibility with Community law of the monopoly granted to pharmacists for the distribution of medicinal products and on the interpretation 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 (Official Journal 1974 L 189, p. 1).

2 The questions were raised in criminal proceedings brought against Jean-Marie Delattre, director of the company Svensson Tour Pol ("Svensson"), for marketing various products in France in breach of Articles L.512, L.596 and L.601 of the French Code de la Santé Publique (Public Health Code).

3 The first of those three articles reserves to pharmacists the right to sell, inter alia, medicinal products; the second provides that any establishment engaged in the preparation, wholesale sale or wholesale distribution of medicinal products and other products of which the sale is reserved to pharmacists must be owned by a pharmacist or by a company in whose management or overall administration a pharmacist is involved; and the third provides that before any proprietary medicinal product is marketed an authorization for that purpose must have been issued by the Minister for Social Affairs.

4 Svensson imports and sells by mail order in France various products manufactured in Belgium, where, it says, they are freely marketed either as foodstuffs or as cosmetic products.

5 Criminal proceedings were instituted against its director, Mr Delattre, following a complaint from the Conseil National de l' Ordre des Pharmaciens, on the ground that certain of the products marketed by his company were medicinal products, so that a special marketing authorization should have been obtained for them and they could be lawfully sold to the public only through pharmacies.

6 The complaint from the Conseil National de l' Ordre des Pharmaciens relates to 11 products, namely four slimming products, "SLIM 4", "Zero 3", "Kilomin" and "Chlorella", a product intended to facilitate digestion, "garlic oil extract", two products intended to improve circulation of the blood, "herbal treatment for legs" and "gel for the relief of tiredness in the legs", one intended to counteract itching, "M27", one to counteract tiredness, "wheatgerm oil + vitamin E", one for the joints, "Mineral 23", and one anti-smoking product, "Turn off", comprising an adjustable cigarette holder and herbal tablets.

7 The various products are presented in the form of tablets, creams or gels and all, except the last mentioned, carry a statement to the effect that they are not medicinal products.

8 Mr Delattre contended, before the national court, that the products in question could not be regarded as medicinal products under Community law but should be classified as foodstuffs, food supplements or cosmetic products, as the case might be, and therefore the Juge d' Instruction at the Tribunal de Grande Instance, Nice, referred the following questions to the Court for a preliminary ruling:

(i) Should the terms "disease" and "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 word "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 I to that directive?

(ii) If the answer to Question 4(i) is in the negative, should not Community law be interpreted as requiring that at all events 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 I 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?"

9 Reference is made to the Report for the Hearing for a fuller account of the facts of the case, the course of the procedure and the written observations submitted to the Court, which are mentioned or discussed hereinafter only in so far as is necessary for the reasoning of the Court.

10 It is necessary first to consider, together, the first three questions submitted by the national court and then, separately, the fourth question.

The first three questions

11 These questions relate to the concept of illness or disease as a Community concept, the classification of certain products in relation to the concept of medicinal product, and the pharmacists' monopoly.

Illness or disease as a Community concept

12 Council Directive 65/65 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), which has been amended several times, gives no definition of illness or disease. The only possible definitions for those terms are those most commonly accepted on the basis of scientific knowledge.

The classification of certain products as medicinal products

13 The same directive defines proprietary medicinal products as "any ready-prepared medicinal product placed on the market under a special name and in a special pack".

14 Pursuant to the first subparagraph of Article 1(2) of Directive 65/65, a medicinal product is "Any substance or combination of substances presented for treating or preventing disease in human beings or animals", and according to the second subparagraph "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 regarded as a medicinal product.

15 That directive thus gives two definitions of medicinal products: a definition of medicinal products "by virtue of their presentation" and a definition of medicinal products "by virtue of their function". A product is a medicinal product if it falls within either of those definitions.

16 It should be added that those two definitions cannot be regarded as strictly distinct from each other. As is stated in paragraph 22 of the judgment in Case 227/82 Van Bennekom [1983] ECR 3883, a substance which is endowed with "properties for treating or preventing disease in human beings or animals" within the meaning of the first Community definition but is not "presented" as such falls within the scope of the second Community definition of a medicinal product.

17 Before the questions raised by the national court are considered, it is appropriate to dispel such doubts as may exist as to the possibility of classifying one and the same product both as a medicinal product and as a cosmetic product within the meaning of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (Official Journal 1976 L 262, p. 169).

18 Article 1(1) of that directive defines a cosmetic product as "any substance or preparation intended for placing in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) 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".

19 As is stated in the fifth recital in the preamble to Directive 76/768, which indicates that that directive relates only to cosmetic products and not to pharmaceutical specialities and medicinal products, the rules which it contains relate only to cosmetic products and not to medicinal products.

20 Thus, whilst it is not impossible that, in dubious cases, the definition of a cosmetic product might be considered in conjunction with that of a medicinal product before a product is classified as a medicinal product by virtue of its function, the fact remains that a product which displays the character of a medicinal product or a proprietary medicinal product does not come within the scope of Directive 76/768 and is subject only to Directive 65/65 and the provisions amending it.

21 That conclusion is, moreover, the only one that fulfils the aim of protecting public health pursued by both directives, since the legal rules applicable to proprietary medicinal products are more rigorous than those applicable to cosmetic products, in view of the particular dangers which the former may present to public health and cosmetic products generally do not.

22 In those circumstances, even if it comes within the definition contained in Article 1(1) of Directive 76/768, a product must nevertheless be treated as a "medicinal product" and be made subject to the corresponding rules if it is presented as possessing properties for the treatment or prevention of illness or disease or if it is intended to be administered with a view to restoring, correcting or modifying physiological functions.

23 The questions referred to the Court seek essentially to determine whether products displaying certain characteristics described by the national court can or must be classified as medicinal products.

24 The first point raised is whether a product which is described in advertisements as being designed to activate natural physiological functions such as digestion or the elimination of bile may be classified in one Member State as a medicinal product although it is classified as a foodstuff in another Member State and 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 (Official Journal 1980 L 229, p. 1), which prohibits all indications "attributing to natural mineral water properties relating to the prevention or treatment or care of a human illness" (Article 9(2)(a)), allows it to be stated that such water may facilitate certain functions such as the hepato-biliary functions.

25 A product presented as being intended to facilitate certain functions such as digestion or the hepato-biliary functions may come within the definition given in the second subparagraph of Article 1(2) of Directive 65/65 since it is capable of being administered with a view to restoring, correcting or modifying physiological functions.

26 In order to decide whether a product of that kind must ultimately be classified as a foodstuff or as a medicinal product it is necessary, according to the judgment in Van Bennekom, supra, to consider each case individually having regard to the pharmacological properties of the product concerned, to such extent as they may have been established in the present state of scientific knowledge.

27 In any event, the fact that a product is classified as a foodstuff in another Member State cannot prevent its being classified as a medicinal product in the Member State concerned when it displays the characteristics of such a product.

28 Although the essential purpose of Directive 65/65 may, as is indicated in the fourth recital in its preamble, be to remove obstacles to trade in proprietary medicinal products within the Community and although for that purpose Article 1 gives a definition of proprietary medicinal products and of medicinal products, it nevertheless constitutes, as is pointed out in the judgment in Van Bennekom, supra, merely a first stage in the approximation of national legislation on the production and distribution of pharmaceutical products.

29 At the present stage of development of Community law, it is difficult to avoid the continued existence, for the time being and, doubtless, so long as harmonization of the measures necessary to ensure the protection of health is not more complete, of differences in the classification of products as between Member States.

30 Finally, the particular features of the legislation specific to natural mineral waters which enable all relevant information to be given to the consumer as to the properties of such waters, without any risk of their being confused with medicinal products, do not affect the definition of medicinal products contained in Directive 65/65.

31 The second point raised is whether a product classified as a foodstuff in one Member State may nevertheless be classified as a medicinal product in another Member State without prior consultation of the various committees which advise the Commission on such matters.

32 In applying the definition of medicinal product given in Article 1(2) of Directive 65/65, the Member States must take account, as is the general rule in such matters, of the results of international scientific research and, in particular, the work of specialized Community committees (judgment in Case 247/84 Motte [1985] ECR 3887). However, no legislation requires them to consult such committees before taking a decision concerning a particular product.

33 The third point raised is whether a product presented as being intended to counteract certain sensations or states such as hunger, heaviness in the legs, tiredness or itching is a medicinal product within the meaning of Directive 65/65.

34 Such states or sensations are in themselves ambiguous. They may be the symptoms of a disease or illness and, combined with other clinical signs, may reveal a pathological condition. Alternatively, as in the case of short-lived tiredness or a need for nourishment, they may have no pathological significance. A reference to such states or sensations in the presentation of a product is therefore not decisive.

35 Consequently, it is for the national authorities to determine, subject to review by the courts, whether or not, having regard to its composition, the risks which might be associated with prolonged consumption of it and its characteristics in general, a product presented in the manner just described constitutes a medicinal product.

36 The final point raised is the extent to which the external form of a product, such as a pill, capsule or tablet, may lead to its being regarded as a medicinal product, even if it is presented as not being a medicinal product and is not presented as possessing - and does not in fact possess - therapeutic or preventive properties.

37 This question must be construed as relating to the definition of a medicinal product given in the first subparagraph of Article 1(2) of Directive 65/65, namely that of a medicinal product by virtue of its presentation.

38 As has already been pointed out by the Court in its judgment in Van Bennekom, supra, to which, moreover, the national court refers, although the external form given to a product may serve as strong evidence of the seller' s or manufacturer' s intention to market the product as a medicinal product, it cannot be the sole or conclusive evidence, since otherwise certain food products which are traditionally presented in a similar form to pharmaceutical products would also be covered.

39 It must, however, be observed that, according to the same judgment, the first definition of medicinal products given by Directive 65/65, which relates to the presentation of the product at issue, must be construed fairly broadly by reason of its very purpose, which is to protect consumers against the marketing of products which do not have therapeutic properties or do not have the properties attributed to them.

40 In the first place, form must be taken to mean not only the form of the product itself (tablets, pills or capsules) but also that of the packaging of the product, which may, for reasons of marketing policy, tend to make it resemble a medicinal product. In the second place, account must be taken of the attitude of an averagely well-informed consumer, in whom the form given to a product may inspire particular confidence similar to that normally inspired in him by a proprietary medicinal product, having regard to the safeguards normally associated with the manufacture and marketing of the latter type of product.

41 In those circumstances, a product may be regarded as a medicinal product by virtue of its presentation if its form and the manner in which it is packaged render it sufficiently similar to a medicinal product and, in particular, if on its packing and the information provided with it reference is made to research by pharmaceutical laboratories or to methods or substances developed by medical practitioners or even to testimonials from medical practitioners commending the qualities of the product in question. A statement that a product is not a medicinal product is persuasive evidence which the national court may take into consideration, but it is not in itself conclusive.

42 Whilst it is true that Council Directive 77/436/EEC of 15 July 1977 on the approximation of the laws of the Member States relating to coffee extracts and chicory extracts (Official Journal 1977 L 172, p. 20), referred to by the national court, speaks of products ordinarily presented "in powder, granular, flake, cube or other solid form", that fact cannot frustrate the application of the criteria relating to medicinal products laid down in Directive 65/65. Moreover, it must be observed that, as has already been pointed out, the form of the product itself is only one of the elements of its presentation to be taken into account in determining whether or not it should be classified as a medicinal product.

43 It must therefore be stated in reply to the questions relating to the definition of medicinal product in Community law that:

(a) a product presented as being intended to facilitate certain physiological functions falls within the scope of the Community definition of medicinal product in the second subparagraph of Article 1(2) of Council Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. In order to decide whether that product is to be categorized as a medicinal product or as a foodstuff, it is necessary to have regard to its pharmacological properties. The fact that such a product is classified as a foodstuff in one Member State does not preclude its being treated as a medicinal product in the State concerned if it possesses the relevant characteristics. The specific features of the legislation concerning natural mineral waters have no relevance to the definition of medicinal product within the meaning of Directive 65/65/EEC;

(b) there is no provision obliging Member States to consult the consultative committees specialized in medicinal products attached to the Community institutions before taking the steps dictated in internal law by the definitions of medicinal product given in Directive 65/65/EEC;

(c) it is for the national authorities to determine, subject to judicial review, whether or not, having regard to its composition, the risks which its prolonged consumption may entail or its side-effects and, more generally, all of its characteristics, a product presented as counteracting certain conditions or sensations, such as hunger, heaviness in the legs, tiredness or itching constitutes a medicinal product;

(d) a product may be regarded as being presented as a medicinal product if its form and the manner in which it is packaged render it sufficiently similar to a medicinal product and, in particular, if on its packing and in the information provided with it reference is made to research by pharmaceutical laboratories, to methods or substances developed by medical practitioners or even to testimonials from medical practitioners commending the qualities of the product. A statement that the product is not medicinal is persuasive evidence which the national court may take into consideration but is not in itself conclusive.

The pharmacists' monopoly

44 The national court wishes to know, essentially, whether the pharmacists' monopoly is a Community concept; whether, in defining the limits of that monopoly, a medicinal product must be defined according to the Community meaning or the national meaning of the term; whether that monopoly constitutes a measure having en effect equivalent to a quantitative restriction and, if so, under what conditions that measure might be considered compatible with Community law.

45 It is necessary first to recall the aim pursued by the Community rules on medicinal products.

46 The sole purpose of Directive 65/65 and the various directives amending it is to give a Community definition of medicinal products and proprietary medicinal products, with the exception of the proprietary medicinal products mentioned in Article 34 of the second Council directive, Directive 75/319/EEC of 20 May 1975 (Official Journal 1975 L 147, p. 13), in order to determine the scope of the harmonized procedure for marketing authorizations introduced by it with a view to facilitating the free movement of such products.

47 That finding is supported by the preamble to Council Directive 85/432/EEC of 16 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 (Official Journal 1985 L 253, p. 34). It states that "the geographical distribution of pharmacies and the monopoly of the supply of medicinal products continue to be matters for the Member States".

48 It follows that as Community law stands at present, no harmonization of the rules on the marketing of medicinal products in each Member State having been carried out (judgment in Joined Cases 87/85 and 88/85 Legia v Minister for Health [1986] ECR 1707), the Member States continue to be empowered to lay down rules on the distribution, in the strict sense of the term, of pharmaceutical products, subject to compliance with the Treaty, in particular the provisions on the free movement of goods.

49 Similarly, the Member States may, subject to the same reservation, impose restrictions on the sale or marketing of products not covered by Directive 65/65, whether they be other medicinal products or substances, pharmaceutical compositions or other products similar to them (judgments in Van Bennekom, supra, and in Case 35/85 Tissier [1986] ECR 1207).

50 As the Court has already held, legislation which restricts or prohibits certain forms of advertising and certain means of sales promotion may, although it does not directly affect imports, be such as to restrict their volume because it affects marketing opportunities for the imported products. The possibility cannot be ruled out that to compel a producer either to adopt advertising or sales promotion schemes which differ from one Member State to another or to discontinue a scheme which he considers to be particularly effective may constitute an obstacle to imports even if the legislation in question applies to domestic products and imported products without distinction. That finding applies a fortiori when the rules in question deprive the trader concerned of the possibility of using not a means of advertising but a method of marketing whereby he realizes almost all his sales, for example mail order (judgments in Case 286/81 Oosthoek' s Uitgeversmaatschappij [1982] ECR 4575 and Case 382/87 Buet v Ministère Publique [1989] ECR 1235).

51 It follows that a monopoly granted to dispensing pharmacists in respect of the marketing of medicinal or other products is capable, in so far as it restricts sales to certain channels, of affecting the possibilities of marketing imported products and may accordingly constitute a measure having an effect equivalent to a quantitative restriction on imports within the meaning of Article 30 of the Treaty.

52 However, a monopoly for pharmacists may be justified by one of the general interests mentioned in Article 36 of the Treaty, which include the protection of health and life of humans. Moreover, since in principle it applies without distinction to domestic and imported products, that monopoly may also be justified on grounds of consumer protection, which, as the Court has held, is one of the imperative requirements which may justify a measure liable to hinder intra-Community trade (judgment in Case 25/88 Wurmser [1989] ECR 1105, paragraph 10).

53 In the absence of harmonization of the rules on the distribution both of medicinal products and of "para-pharmaceutical" products, it is for the Member States to choose the level to which they wish to ensure the protection of public health.

54 In the case of medicinal products within the meaning of Directive 65/65, account must be taken of the very particular nature of the product and the market involved, which explains the fact that in all the Member States there are, albeit with differences of detail, rules restricting their marketing and, in particular, some form of monopoly on the retail sale of such products is granted to pharmacists by reason of the safeguards which pharmacists must provide and the information which they must be in a position to furnish to the consumer.

55 It must nevertheless be observed that, in the abovementioned part of the preamble to Directive 85/432, the Council refers to and thus acknowledges the existence of a pharmacists' monopoly in the Member States, but does not, in view of the fact that it is not a Community concept, give any definition of it.

56 It follows that although in principle the Member States may reserve to pharmacists the right to make retail sales of products that fall within the Community definition of medicinal products and although, in those circumstances, their monopoly over those products may be presumed to constitute an appropriate way of protecting public health, evidence to the contrary may be produced with respect to certain products whose use would not involve any serious danger to public health and whose inclusion within the pharmacists' monopoly would seem manifestly disproportionate, that is to say contrary to the principles laid down by the Court for the interpretation of Articles 30 to 36 of the Treaty.

57 If pharmacists are granted a monopoly of other products, such as "para-pharmaceutical" products, which may be of widely varying kinds, the need for such a monopoly in order to protect public health or consumers must, regardless of how the products concerned are classified under national law, be established in each individual case, and those two aims must not be attainable by measures less restrictive of intra-Community trade.

58 With regard, in particular, to products of the type at issue in the main proceedings, which are presented inter alia as facilitating weight loss, promoting certain physiological functions, such as digestion, or counteracting certain sensations or states, such as tiredness, account must be taken, in cases where the products do not fall within the Community definition of medicinal products, of the real dangers which they may present to public health, in general or under certain conditions of use, and of the possible errors into which they might lead an averagely well-informed consumer.

59 It is for the national court to decide, having regard to those criteria, whether the action before it is well founded.

60 It must therefore be stated in reply to the questions concerning the pharmacists' monopoly that:

under Community law as it now stands, the determination of the rules governing the distribution of pharmaceutical products remains a matter for the Member States, provided that the provisions of the Treaty, and in particular those relating to the free movement of goods, are respected;

a monopoly of the right to distribute medicinal or other products, granted to dispensing pharmacists, may constitute a barrier to importation;

if a Member State chooses to restrict to pharmacists the right to distribute products of that kind, such a barrier is, in principle and in the absence of any evidence to the contrary, justified in so far as it concerns medicinal products within the meaning of Council Directive 65/65/EEC;

where other products are concerned, however they may be classified in national law, it is for the national court to determine whether a monopoly of the right to market such products granted to pharmacists is necessary for the protection of public health or of consumers and whether those two aims cannot be achieved by measures less restrictive of intra-Community trade.

The fourth question

61 The national court' s fourth question seeks to determine whether Directive 74/329 prevents a Member State from restricting trade in a product such as guar gum, referred to in Annex I to the directive, and if not, under what conditions such a restriction is justified under Community law.

62 Directive 74/329 is concerned solely with the approximation of the laws of the Member States on emulsifiers, stabilizers, thickeners and gelling agents for use as additives in the processing of foodstuffs. The measures which may be taken by the Member States concerning the substances listed in Annex I to the directive where they are used for another purpose therefore fall outside its scope.

63 That is the case as regards guar gum, which is at issue in the main proceedings. According to the observations submitted to the Court by Mr Delattre, of the 11 products with which the proceedings against him are concerned only "Zero 3" is composed of guar gum, and that product "creates a feeling of satiety which makes it possible to eat less".

64 It follows that the compatibility with Community law of restrictions on trade in a product such as "Zero 3" must be assessed in relation to Articles 30 and 36 of the Treaty.

65 A measure whereby a Member State makes a substance such as guar gum, when employed as part of a method intended to facilitate weight loss, subject to marketing authorization and to the pharmacists' monopoly, however that product may be classified in any other sphere of national law, may constitute a restriction on imports.

66 Under Articles 30 and 36 of the Treaty, such a restriction is, however, permissible within the limits and on the grounds mentioned above with respect to the pharmacists' monopoly. In order to decide, in a case where a product made of guar gum is not a medicinal product within the meaning of Directive 65/65, whether that restriction is justified, it is necessary in particular to take account of the risk that may be associated with a considerable loss of weight without special supervision and of the risk of consumers being misled in so far as they might attribute special properties to the product by reason of its presentation or packaging.

67 It must therefore be stated in reply to the fourth question that Council Directive 74/329/EEC and Articles 30 and 36 of the EEC Treaty must be interpreted as meaning that a measure whereby a Member State makes a product such as guar gum subject to marketing authorization and to the sales monopoly of pharmacists when it is used as part of a method intended to facilitate weight loss, however that product may be classified in any other sphere of national law, does not fall within the scope of that directive, but may constitute a barrier to importation. When the product in issue is not a medicinal product within the meaning of Directive 65/65/EEC, such a measure is not permissible under Community law unless it is necessary in order to protect public health or consumers and is proportionate to those aims.

Costs

68 The costs incurred by the French Government, the Italian Government and the Commission of the European Communities, which have submitted observations to the Court, are not recoverable. Since these proceedings are, in so far as the parties to the main proceedings are concerned, in the nature of a step in the action pending before the national court, the decision on costs is a matter for that court.

On those grounds,

THE COURT (Fifth Chamber),

in answer to the questions referred to it by the Juge d' Instruction at the Tribunal de Grande Instance, Nice, by order of 12 December 1988, hereby rules:

1. Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products gives no definition of disease.

2. (a) A product presented as being intended to facilitate certain physiological functions falls within the scope of the Community definition of medicinal product in the second subparagraph of Article 1(2) of Council Directive 65/65/EEC. In order to decide whether that product is to be categorized as a medicinal product or as a foodstuff, it is necessary to have regard to its pharmacological properties. The fact that such a product is classified as a foodstuff in one Member State does not preclude its being treated as a medicinal product in the State concerned if it possesses the relevant characteristics. The specific features of the legislation concerning natural mineral waters have no relevance to the definition of medicinal product within the meaning of Directive 65/65/EEC;

(b) There is no provision obliging Member States to consult the consultative committees specialized in medicinal products attached to the Community institutions before taking the steps dictated in internal law by the definitions of medicinal product given in Directive 65/65/EEC;

(c) It is for the national authorities to determine, subject to judicial review, whether or not, having regard to its composition, the risks which its prolonged consumption may entail or its side-effects and, more generally, all of its characteristics, a product presented as counteracting certain conditions or sensations, such as hunger, heaviness in the legs, tiredness or itching constitutes a medicinal product;

(d) A product may be regarded as being presented as a medicinal product if its form and the manner in which it is packaged render it sufficiently similar to a medicinal product and, in particular, if on its packing and in the information provided with it reference is made to research by pharmaceutical laboratories, to methods or substances developed by medical practitioners or even to testimonials from medical practitioners commending the qualities of the product. A statement that the product is not medicinal is persuasive evidence which the national court may take into consideration but is not in itself conclusive.

3. Under Community law as it now stands, the determination of the rules governing the distribution of pharmaceutical products remains a matter for the Member States, provided that the provisions of the Treaty, and in particular those relating to the free movement of goods, are respected;

A monopoly of the right to distribute medicinal or other products, granted to dispensing pharmacists, may constitute a barrier to importation;

If a Member State chooses to restrict to pharmacists the right to distribute products of that kind, such a barrier is, in principle and in the absence of any evidence to the contrary, justified in so far as it concerns medicinal products within the meaning of Council Directive 65/65/EEC;

Where other products are concerned, however they may be classified in national law, it is for the national court to determine whether a monopoly of the right to market such products granted to pharmacists is necessary for the protection of public health or of consumers and whether those two aims cannot be achieved by measures less restrictive of intra-Community trade.

4. Council Directive 74/329/EEC and Articles 30 and 36 of the EEC Treaty must be interpreted as meaning that a measure whereby a Member State makes a product such as guar gum subject to marketing authorization and to the sales monopoly of pharmacists when it is used as part of a method intended to facilitate weight loss, however that product may be classified in any other sphere of national law, does not fall within the scope of that directive, but may constitute a barrier to importation. When the product in issue is not a medicinal product within the meaning of Directive 65/65/EEC, such a measure is not permissible under Community law unless it is necessary in order to protect public health or consumers and is proportionate to those aims.