C-369/88

Mr President, 2. Following the complaint by the Conseil Members of the Court, National de l'Ordre des Pharmaciens, Mr Delattre, a director of the French company Svensson Tour Pol S.à r. 1. ('Svensson'), was charged with unlawfully practising the profession of pharmacist on the ground that he had sold certain products which, under the applicable French legislation, are regarded as medicinal products; an author- 1. The questions submitted to this Court for ization is required to place such products on a preliminary ruling by the Tribunal de the market and, in addition, they may be Grande Instance, Nice, relate to the inter- sold only through pharmacies. 3 pretation of the Community legislation on medicinal products 1 and other Community provisions concerning products (in particular cosmetics and foodstuffs) which may have an impact on health, 2 and to Articles 30 and 36 of the Treaty. The products with which the criminal proceedings before the national court are concerned are 11 in number: four slimming products ('Slim 4', 'Zéro 3', 'Kilomin' and 'Chlorella'), a garlic-based product to assist digestion ('Macérat huileux d'ail'), two products to improve the circulation of the blood (herbal treatment for the legs and a I refer you to the Report for the Hearing gel for tiredness in the legs), an anti-itching for matters of detail but will summarize product ('M27'), a product for the relief of here the essential facts of the case. tiredness (wheatgerm oil with vitamin E), a product for the joints ('Mineral 23') and, * Original language: Italian, finally, a product to help people stop 1 — First and second Council Directives (65/65 and 75/319) smoking ('Turn-off'). 4 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (Official Journal, English Special Edition 1965-1966, p. 20, and OJ 1975 L 147, p. 13). 2 — The national court refers in particular to certain provisions of the following directives: — Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States Svensson, whose registered office is in Nice, relating to cosmetic products (OJ L 262, p. 169); — Council Directive 74/329/EEC of 18 June 1974 on the imports and sells by mail order those approximation of the laws of the Member States products, which are manufactured in relating to emulsifiers, stabilizers, thickeners and gelling agents for use in foodstuffs (OJ L 189, p. 1) Belgium where they are classified not as — Council Directive 80/777/EEC of 15 July 1980 on the medicinal products but (with the exception approximation of the laws of the Member States relating to the exploitation and marketing of natural mineral waters (OJ L 229, p. 1); — Council Directive 85/573/EEC of 19 December 1985 3 — See Articles L.512, L.596 and L.601 of the Code de la which amends Council Directive 77/436/EEC on the Santé Publique. approximation of the laws of the Member States 4 — By virtue of Article L.511 of the Code de Santé Publique, relating to coffee extracts and chicory extracts (OJ all anti-smoking products are treated as medicinal L 372, p. 22). products.

of 'Turn-off') either as food supplements or Member State were free to adopt its as cosmetic products; the same products are own definition of 'maladie', with the also distributed, under the same classifi- result that it was able to prohibit on its cations, in the Netherlands, Luxembourg, own territory the sale of a product Germany, the United Kingdom and Spain. legally marketed as food in another Member State, on the ground that it was a medicinal product, would it be free to do so without even consulting the special committees set up under the Mr Delattre maintains that the products in applicable legislation? question are not medicinal products, eight of them being classified in Belgium as food- stuffs and two ('M27' and gel for the legs) as cosmetic products. Consequently, the application to them in France of the provisions governing medicinal products, II. Having regard to the judgment in Van involving the prior issue of a marketing Bennekom, is a Member State allowed authorization, is, in Mr Delattre's opinion, to limit the import and marketing of a incompatible with Community law, in product extracted from a commonly particular the provisions on the free consumed plant (garlic) simply because movement of goods. the external form of the product (thus, without any indication or recommen- dation showing it to be 'medicinal') is typical of medicinal products, even though Directive 85/573 permits the 3. The Juge d'Instruction at the Tribunal de use of such a presentation for extracts Grande Instance, Nice, therefore submitted of chicory, without requiring the latter four questions for a preliminary ruling, to be classified as medicinal product; which I think it is reasonable to summarize and is the measure in question justified as follows: under Article 36 even though the product concerned bears a clear statement that it is not a medicinal product, it is not presented as having I. Is there a Community definition of the therapeutic properties, its ingredients terms 'disease' and 'illness' (with regard are not of a high concentration and to the treatment of which the term consumption of it involves no scient- 'medicinal product' is used) which ifically ascertained risk to health? prevents one and the same product from being classified as food in one Member State and as a medicine in another, and does such a definition extend to natural physiological states such as hunger, tiredness, heaviness in III. Does the creation of a monopoly for the legs and itching, account being pharmacists fall within the powers of taken of the fact that, for example, the Member States and does it extend Directive 80/777/EEC on natural only to medicinal products of the kind mineral waters does not treat as defined in Directive 65/65 or also to illnesses physiological conditions those defined by each Member State; concerning digestion and the elimina- and does the prohibition of sale tion of bile; if, on the other hand, each otherwise than through pharmacies of

That said, I would point out at the outset that the questions submitted, in particular the first two, have to a large extent been A — General observations answered in the judgment in Van Bennekom, 5 but they also raise different issues, concerning in particular a systematic approach to Directive 65/65 in relation to other Community legislation which may be regarded as helping in some way to define 4. The preliminary questions, thus the scope of that directive. summarized, show clearly that the national court wishes to determine, on the basis of an interpretation by the Court of Justice, whether it is possible to trace a clear borderline between medicinal and other products (be they cosmetics or foodstuffs), a delimitation which, above all, would allow I think that it is therefore appropriate, the products at issue to be classified before going on to examine the individual according to Community criteria. Secondly, questions, to analyse briefly the extent to the national court asks whether, in the which national provisions on the manu- absence of a Community classification for facture and marketing of medicinal products the products in question, which would of have been harmonized and to consider course result in the reservation in Article 36 possible links with the legislation concerning being inapplicable, the obligation to obtain cosmetics and foodstuffs, and also the prior authorization for the marketing of a existing or potential problems concerning product which is classified differently in one the free movement of medicinal products or more other Member States is compatible and of the products now described as with Article 30 et seq. of the Treaty; and, 'para-pharmaceutical' products. finally, whether the different extent of the sales monopoly accorded to pharmacists, 5 — Case 227/82, [1983] ECR 3883.

5. Directive 65/65, the purpose of which is has been issued by a competent authority of to remove obstacles to the free movement of the Member State concerned'. medicinal products, is the basic instrument. It represents only the first stage in the harmonization of the national provisions which, although taken further by the second directive referred to earlier, Directive This gives rise, therefore, to a specific ob- 75/319, is still only partial since, on the one ligation for Member States to impose the hand, it does not apply to certain categories requirement of a prior authorization only of medicinal products (for example vaccines, for the marketing of proprietary medicinal serums, homeopathic proprietary medicinal products. On the other hand, the Member products and certain others — see Article 34 States have no obligation but rather a mere of the second directive); on the other, it has power, to be exercised within the limits not yet introduced machinery for imposed by Articles 30 and 36 of the EEC Community authorization or for reciprocal Treaty with respect to imported products, to recognition of national authorizations. subject to the requirement of prior authori- zation the marketing of products (a) which conform to the Community definition of medicinal products but not to that of proprietary medicinal products or those Pursuant to Article 1 of Directive 65/65, a which are expressly excluded from the scope medicinal product is 'any substance or of the directive, and (b) those which, combination of substances presented for although not falling within the Community treating or preventing disease in human definition of medicinal products, are beings or animals' (first definition, classified as such by one or more Member medicinal product by virtue of presentation). States or are in any event liable to have an The same article states that 'any substance impact on health. 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 The Court itself has confirmed that 'subject physiological functions in human beings or to Article 30 et seq. of the Treaty in animals' is also to be regarded as a concerning products imported from other medicinal product (second definition, Member States, Community law does not medicinal product by virtue of function). affect the right of Member States to subject such substances to controls or to require prior authorization in accordance with their own national laws on medicinal products'. 6 Any ready-prepared product placed on the market under a special name and in a special pack is defined as a proprietary medicinal product. Indeed, notwithstanding the fact that the Court stated that the Community concept of medicinal product must be interpreted broadly, 7 it is quite possible for one or more

Member State to adopt an even wider de- That having been said, it is necessary to finition of medicinal products; in any event, determine the nature of the products in other than in the case of the 'proprietary question to see whether they come within medicinal products' referred to in Directive the Community definition of medicinal 65/65, it is necessary to ascertain, as product. Such an examination is extremely regards imported products, whether the complex precisely because, in view of the national restrictions on marketing are particular features of the sector in question, compatible with Articles 30 and 36. scientific rather than legal considerations are involved. In addition, the Community definitions mentioned earlier raise more than a few problems concerning not only those products which purport to treat an illness (first definition) but also, in particular, products which aim at 'restoring, correcting or modifying physiological 6. As far as the present case is concerned, it functions' (second definition), in view of the is clear that the following alternative looser terms used in the second case. presents itself with respect to the products referred to by the national court: they are either proprietary medicinal products within the meaning of Directive 65/65 and for that very reason their marketing must be subject to prior authorization in all the Member States; or else they do not fall within that concept and therefore, if they are imported, 7. In particular, with regard to the first the question arises of the compatibility of definition, the difficulty lies precisely in prior authorization with Articles 30 and 36 the fact that medicinal products are — of the Treaty, since the requirement of that obviously — defined by reference to the authorization appears prima facie to be an illness concerned, but the latter term is not obstacle to the free movement of goods. itself defined. And the second definition is formulated in such broad terms that, if read literally, it can apply both to medicinal products and to foodstuffs, and also to some cosmetics.

8. With respect to cosmetics, it will be primarily preventive effect (in the same way remembered that, pursuant to Article 1 of as normal hand creams). On the other hand, Directive 76/768, a cosmetic product means if it should be found that those products 'any substance or preparation intended for have a significant impact on the physio- placing in contact with the various external logical functions (if, for example, the leg gel parts of the human body . . . or with the acts on the tissue in such a way as to cure teeth and the mucous membranes of the oral or prevent poor circulation) then this is cavity with a view exclusively or principally clearly a case of a medicinal product. to cleaning them, perfuming them or protecting them in order to keep them in good condition, change their appearance or correct body odours'. As is apparent, that is a very precise and detailed definition which, in principle, enables the sector in question to be distinguished from that of medicinal products. None the less, problems may arise It is for the national court, perhaps with the regarding products which come not only help of an expert, ultimately to decide how within that definition but also within that of the products in question are to be classified medicinal products (a circumstance which is on the basis of the criteria suggested here. liable to arise above all in the case of cosmetics which serve a protective function); in such cases, a useful criterion may be derived from the predominant use and therefore, in some degree, from the view generally held by consumers. 9. More complex is the relationship with the legislation on food products — which of course does not give a Community de- finition of such products.

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O P I N I O N O F MR TESAURO —CASE C-369/88

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DELATTRE

I consider that such an interpretation is part of the daily diet and are indispensable consonant with the aim pursued by that for the proper functioning of the body. It is legislation. And whilst it is true that the clear that in such cases, as the Court itself second definition concerns those products stated in Van Bennekom with respect to which, regardless of presentation, are vitamins, 11 the substances in question suitable for 'restoring, correcting or cannot be regarded as medicinal products modifying physiological functions', it is also when they are consumed in quantities corre- true, on the one hand, that it is formulated sponding to normal requirements and to in broad terms in order to embrace make up for a deficiency thereof resulting substances which may in particular modify from particular physiological conditions physiological functions without having which are not attributable to a pathological properties enabling them to treat or prevent abnormality. an illness properly so called; on the other hand, it seems to me beyond doubt that such a formulation cannot be interpreted so as to extend to those products which, although without doubt inherently able to affect physiological functions, have an Against the background of those general essentially nutritional purpose. Otherwise, observations, we can now formulate a more salt, for example, which, in the absence of specific answer to the individual questions other products, is used by sportsmen to submitted by the French court, where such prevent or cure cramp, would have to be answers do not follow directly from the classified as a medicinal product. foregoing considerations.

It is indeed true that tiredness or indigestion may also be a symptom or effect of a patho- logical condition; however, in such cases products made from natural substances, It follows that differing classifications of which merely amount to a food supplement one and the same product can legitimately designed to promote the proper functioning exist not because the term illness is defined of the body, will certainly not provide an differently in the various Member States but adequate remedy for the pathological rather because there are products which, condition in question: the primary need will although capable of being brought within be for products — medicinal products — the definition of medicinal products by which treat the illness itself and do not virtue of their function within the meaning merely provide relief from the tiredness of the directive, are primarily intended for which it causes. nutritional purposes. í refer in particular to those substances, essential for human nour- ishment, which are taken in order to remedy a deficiency of them resulting from what might be called temporary physiological conditions and therefore in amounts not Thus, for example, a product to combat exceeding a specified level. tiredness (made up of wheatgerm oil and vitamin E), such as that at issue in the main proceedings, cannot in my view reasonably be classified as a medicinal product since it is not intended, as such, to treat any patho- logical condition but merely has a beneficial In such cases of course it becomes difficult, effect and provides relief for a physiological above all in the absence of harmonization, condition the causes of which are natural to say to what extent such a substance is and, I would add, entirely normal. merely a food supplement (intended exclu- sively to add to daily nourishment) and when, on the other hand, because of its high concentration or a dosage which exceeds normal requirements, it becomes a medicinal product. As the Court itself stated in Van That having been said, I shall merely Bennekom with regard to vitamins, their observe that the lack of a codified definition classification as medicinal products 'must be in Community legislation of the term illness, carried out case by case, having regard to

In view of the uncertainty and the devel- opment of scientific knowledge in many areas of pharmacology and, in particular, for the present purposes, regarding determi- nation of the level of concentration at which the consumption of substances intended essentially for nutritional purposes may The Court has already given a ruling on become harmful, it will be necessary to that definition in Vati Bennekom, in which it decide case by case how the products in stated that 'a product is "presented for question are to be classified. Therefore, it is treating or preventing disease" within the entirely possible that a Member State might, meaning of Directive 65/65 not only when on the basis of domestic legislation, regard it is expressly "indicated" or "recom- such products as medicinal products, subject mended" as such . . . but also whenever any to the possibility of review by the courts to averagely well-informed consumer gains the ensure compliance with Community law in impression, which, provided it is definite, other respects, in particular the question of may even result from implication, that the compatibility with Article 30 et seq. of the product in question should, regard being EEC Treaty. had to its presentation, have an effect such as is described by the first part of the Community definition'. 13 This means that the directive in question is intended to 'protect' consumers not only from harmful or toxic medicinal products but also from From that standpoint, consultation of the the various products presented as adequate Committee for Proprietary Medicinal remedies. And it is precisely for that reason Products or the Standing Committee for that 'the concept of the "presentation" of a Foodstuffs or other special committees is product must be broadly construed'. 14 The not an appropriate way of avoiding differing Court also stated in the same judgment that classifications of the same product since the the external form given to the product in classification of products is not within the question (including pills or capsules) may remit of those committees (and in any case serve as strong evidence of the seller's or their opinions are not binding on the manufacturer's intention to market the Member States). product as a medicinal product, adding, however, that such evidence will not be conclusive 'since otherwise certain food products which are traditionally presented in a similar form to pharmaceutical products would also be covered'. 15 12. The second question relates in particular to the concept of medicinal 13 — Supra, paragraph 18 14 — Ibid, paragraph 17 12 — Supra, paragraph 29 15 — Ibid, paragraph 19

Let me say straight away that the reference to chicory extracts is of little relevance and in any event is not decisive, since that product, unless presented as being able to It is not beyond probability, however, that a treat or prevent an illness, could certainly be Member State may, where a product is of a brought within the category of food high concentration or becomes harmful products which are traditionally (and often when used to excess, regard it as a for eminently commercial reasons) medicinal product and impose the presented in forms similar to those of requirement of prior authorization. In such medicinal products; and also precisely circumstances it will be for the national because it is covered by a specific provision court to ascertain, with the assistance of an applicable only to the product expressly expert if necessary, whether the classifi- mentioned. cation is appropriate having regard to the available scientific knowledge.

rules which hinder free movement may be complex and delicate, in so far as there are 'justified' under Article 36, on grounds of uncertainties as to the critical threshold at health, only where such rules are which consumption of the products at issue proportional and not excessive in relation to might endanger health. the requirement concerned and there are no alternative solutions which would allow the Member States to achieve the same aim with less disturbance of trade. Therefore, whilst it must again be stressed that the obstacles to the free movement of goods may be justified on the grounds of protection of health under Article 36 of the EEC Treaty, it must be added that that With particular reference to the issue of provision cannot be invoked to limit the protection of health, the Court has stated marketing of products (whether or not described as medicinal) which undeniably on several occasions 17 that the Member present no direct or indirect danger to States may, in the absence of harmonization health. at Community level and in so far as there are uncertainties in the present state of scientific research, decide what degree of protection of the health and life of humans is justified. Their discretion is not, however, absolute, nor are powers reserved to them: Even if the national court were to the Member States must be in a determine — as it seems to have done in the position — and the burden of proof falls on present case — that such a product does not them — to justify the restrictions adopted have and is not presented as having thera- by them on grounds of protection of health, peutic or preventive properties, does not in so far as the rules in question must be contain substances in a high concentration limited to what is necessary to achieve the such as to make it a medicinal product and lawfully pursued aim of protecting health. does not present any serious risk to health, In Van Bennekom, the Court stated that 'it it is clear that the requirement of prior auth- is for the national authorities to demon- orization for such a product, when strate in each case that their rules are imported, is not justified under Article 36 of necessary to give effective protection to the the Treaty. interests referred to in Article 36 of the Treaty and, in particular, to show that the marketing of the product in question creates a serious risk to public health'. 18 I would add, finally, that an unavoidable precondition for reliance on Article 36 is that the restrictive measure must not constitute a means of arbitrary discrimina- tion or a disguised restriction on trade: and Consideration of that question, which is a that would be the case if it were found or matter for the national court, is extremely demonstrated that products similar to those at issue are marketed in France, as 17 — See the ludgments in Case 174/82 Sandoz [1983] contended by Mr Delattre, without being ECR 2445 and Case 178/84 Commission v Germany [1987] ECR 1227 subject to the requirement of prior authori- 18 — Stipra, paragraph 40 zation.

As is expressly recognized in the second recital in the preamble to Directive It is therefore necessary, by way of 85/432, 19 the creation of a monopoly for preliminary, to establish whether trading the distribution of medicinal products is a rules of the kind at issue add up to a matter for the Member States. Such a measure equivalent to a quantitative monopoly is not in principle linked with the restriction within the meaning of Article 30. Community legislation on medicinal products, in so far as the objectives and scope of the two sets of rules are different. The main purpose of Directive 65/65 is to subject proprietary medicinal products to Let me say first of all that a measure which the requirement of prior marketing author- reserves the sale of a category of products ization and it does not indicate which to specified persons in specified places may products are to be subjected to restrictive constitute a measure having equivalent conditions as to distribution; still less does it effect, in the sense defined by the Court in make sales subject to the requirement of a the well-known Dassonville judgment, 20 medical prescription. The only Community since they are trading rules 'capable of limitation is, in principle, that such a sales hindering, directly or indirectly, actually or system must not be incompatible with potentially, intra-Community trade'. Article 30 et seq. of the Treaty.

Mr Delattre contends that rules on sales In particular, rules such as those at issue, which prescribe a specific distribution which confine sales to a restricted distri- network constitute a measure having an bution network, may affect imports both by effect equivalent to a quantitative restriction reducing the actual volume of sales and by and that such a restriction may not be causing prices to rise. regarded as justified when applied to products for the use of which the advice of a pharmacist is unnecessary. The Commission, on the other hand, expresses

In fact, such obstacles to free movement do not arise, in such cases, from a disparity between national laws but rather from the very existence of the laws in question, in so far as their existence bears no relation to the 15. In the case of the monopoly enjoyed by fact that the Member State from which they pharmacies, on the other hand, it is clear originate prohibits sales of them otherwise that the products in question cannot be than through pharmacies or, conversely, marketed otherwise than through phar- authorizes such sales. 21 macies and the fact that one and the same product may be confined to sales in phar- macies in one Member State and authorized to be sold through other outlets in another Member State together with the fact that, in principle, it is not impossible for one Member State to extend the pharmacists' monopoly to products that are certainly not The relevant case-law of the Court may at medicinal products, in itself makes it unac- first sight appear to have adopted divergent ceptable for that Member State not to have approaches. In some cases, the Court has to justify such rules under Article 36. held that it is necessary to examine the allegedly imperative requirement, in line with the course taken in the famous Cassis de Dijon case, in order to establish whether the means used to attain that end are proportionate in relation to the aim pursued, as well as necessary, in the sense Returning to the present case, I shall merely that that objective could not be achieved by point out that here too the imperative another means which interfered to a lesser requirement relied on in order to justify the extent with Community trade. 22 In other, obstacles to free movement by both the apparently similar cases, it seems that no Commission and the Member States which link with imports was attributed to rules of submitted observations is the protection of that kind. But on closer examination it is health. 21 — See in that regard the O p i n i o n of M r Advocate General 23 — Judgment in Case 155/80 Oebel [1981] EC R 1993, para Van Gerven of 29 June 1989 in Case C-145/88 ß 6 Q [1989] E C R 3865 graphs 19 and 2C

Health is without doubt intrinsically 'medicinal products' are concerned, the deserving of protection at Community level Member States should be lawfully entitled and therefore that objective is, in principle, to grant pharmacists a monopoly. lawful. It is obvious that national legislation which limits the sale of medicinal products to specialized businesses (pharmacies) and to qualified professional persons (phar- On the other hand, for products which do macists) seeks to safeguard health, since the not fall within the Community definition of products in question are, by definition, proprietary medicinal products (whether linked with health. they are medicinal products under the legis- lation of one or more Member States or are products of a different kind), a pharmacists' monopoly on sales obviously cannot be The decisions of the Court to which I justified in absolute terms. referred earlier support the view that, in view of the nature of the rules at issue, it is incumbent on the national authorities to show that the sale of the products in In fact, it will be necessary to establish in question otherwise than through pharmacies each individual case that the product in constitutes a 'genuine risk to health'. question is such that it presents risks to health and, in particular, that the presence of a pharmacist is essential when it is sold. That applies with greater force where, as Having said that, I can do no less than draw has been contended in the present case with attention to the inconsistency which would regard to the 'La Vie Claire' and 'Vitamin afflict the entire system if it were to be System' products, similar products of concluded that a Member State should, in domestic manufacture are marketed each instance, justify the decision to reserve otherwise than through pharmacies: to pharmacists the sale of products classified discrimination which, let it be remembered, as 'proprietary medicinal products' within renders Article 36 of the Treaty inap- the meaning of Directive 65/65. And plicable. although, as I have already pointed out, the aim of the directive in question is certainly not to subject medicinal products to a restricted distribution network, it is never- theless true that, where a product falls 16. In its last question, the national court within the Community definition of asks whether the products referred to in proprietary medicinal products, that product Annex I to Directive 74/329 may be must, because of its intrinsic properties, be subjected to trade restrictions by the recognized as one which may possibly affect Member States. health, with the result that its consumption must be subject to special safeguards. Indeed, the adoption of a Community de- finition of medicinal products, implying in The answer is clearly negative but — and it principle that a particular product is to be hardly needs saying — only in the case of classified in the same way in all the Member emulsifiers, stabilizers, thickeners and States and, in particular, that the nature of gelling agents which may be used in food- the product in question is such that it may stuffs. Let me explain: the directive in have an impact on health, renders it lawful question harmonized the provisions on and also logical that, as far as such certain agents used in the preparation of

(2) If the national court finds that a product is not a medicinal p r o d u c t , by virtue either of its presentation or its function, and does not, on the basis of veri- fiable scientific knowledge, present any risk to health, the requirement of a prior marketing authorization for imported products is incompatible with Article 30 and is not justified under Article 36.

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OPINION OF MR TESAURO — CASE C-369/88

(3) The creation of a sales monopoly for pharmacists is a matter for the Member States; except, in principle, in the case of products which are proprietary medicinal products within the meaning of Directive 65/65, the extension of that monopoly to other products (whether or not classified as medicinal products), where they are imported, is justified by the requirement of the protection of health where the presence of a pharmacist is necessary when such products are sold.

(4) Directive 74/329 precludes the Member States from imposing restrictions on the free movement of the products referred to in Annex I thereto only where they are used for the purposes specified in the directive. Any restrictions imposed on the marketing of guar gum, when it is not used for the purposes envisaged in that directive, must therefore be examined the light of Article 30 et seq. of the Treaty.

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