C-112/89

OPINION OF MR LENZ—CASE C-U2/89

OPINION OF MR ADVOCATE GENERAL LEN2 delivered on 19 February 1991 *

Table of contents

A — The facts 1714

B — Analysis 1716

The first question 1716

medicinal product 1719

(1) Harmfulness 1719

(2) Therapeutic efficacy 1721

(b) Facilitation of trade 1721

II — The purported danger of an unreasonable extension of the concept of medicinal

product 1722

(a) The first par; of ihe definition of a medicinal product 1723

(b) The second part of the definition of a medicinal product 1723

II — The relationship between the two definitions in the event of overlapping; the criteria for delimitation 1724

1 The relationship between the two definitions 1724

2 The criteria for delimitation, derived from the meaning and purpose of Directive 65/65 1728

(a) Protection of public health 1728

(3b) Comparison with the properties of products classified by

reason of their properties 1731

(aa) Relevance of such comparison 1731

(bb) Comparison with (other) medicinal products 1732

(cc) Comparison with (other) cosmetic products 1732 I- 1713

OPINION OF MR LENZ — CASE C-112/89

2. The facts, for the details of which reference may be made to the Report for the Hearing, may be summarized as 3. The plaintiff took the view that the follows: the parties to the main proceedings product marketed by the defendant (hereinafter referred to as 'the plaintiff' and constituted a medicinal product within the meaning of the Netherlands legislation and 1 — Council Directive 65/65/EEC of 26 January 1965 (OJ English Special Edition J 965-1966, p. 20). Directive that by marketing it as a cosmetic product 89/341/EEC (OJ 1989 L 142, p. 11) has replaced the the defendant was infringing that legislation term 'proprietary medicinal product' by 'medicinal product' in the title of Directive 65 / 65 ; it must be and thereby also acting unlawfully towards transposed before 1 January Î992. the plaintiff. The defendant considered that 2 — Council Directive 76/768/EEC of 27 July 1976 (OJ 1976 L 262, p. 169). its product did not constitute a medicinal

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product, since male baldness was not a first sentence of the definition of a disease. The plaintiff called upon the medicinal product in Article 1(2) of defendant to refrain from its actions, and Directive 65 / 65 / EEC nevertheless be initiated proceedings for an interim order to regarded as a medicinal product if it may be that effect. The Hoge Raad, called upon to administered to human beings with a view consider the matter in an appeal for to restoring, correcting or modifying physio­ cassation, took the view that the concept of logical functions?' medicinal product must have the same meaning in the Netherlands as in the Community legislation. It referred in that regard to Article 1(2) of Directive 65/65, which reads as follows:

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OPINION OF MR LENZ —CASE C-II2/89

B — Analysis fact that it 'may be administered' for one of the purposes listed, does not establish any such link between the concepts of 'medicinal product' and 'disease'. Had such a link been intended, the authors of the directive could The first question have simply copied the first part word for word and couched the second part in, for instance, the following terms:

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in proprietar)' medicinal products within the ization. Article 21 provides that the author­ Community and thus directly affect the ization may not be suspended or revoked on establishment and functioning of the grounds other than those set out in the common market must be removed through directive. The requirement of an author­ the approximation of laws (third to fifth ization thus forms the hub and the linchpin recitals). of the whole system of rules.

13. (a) I shall first consider the aspect of the protection of public health. 16. Three different categories may be discerned among the grounds for refusal set out in Article 5. 14. (aa) Proprietary medicinal products for human use intended to be placed on the market in Member States require an auth­ 17. The first category seeks to protect orization under Chapter II of the directive, public health against actual, material which specifies the relevant conditions and dangers. It covers the cases of actual harm- detailed rules; Chapter III deals with the fulness and inadequate therapeutic efficacy. suspension and revocation of such author­ Authorization is to be refused 'if, after veri­ ization in general. Chapter IV contains fication of the particulars and documents provisions concerning labelling, listed in Article 4, it proves that the non-compliance with which may lead to the proprietary medicinal product is harmful in suspension or revocation of the author­ the normal conditions of use, or that its

5 — Case 33/85 Procureur áe la Republique \ Timer [1986] 7 — The grounds for lhe suspension or revocation of the auth- FCR I2C7 orization set out in Anicie II of the directive arc ciosek 6 — Paragraph 26 modelled on the grounds for refusai m Article 5

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OPINION OF MR LENZ —CASE C-II2/89

9 _ Opinion in Case 227/82 van Bennekom [1983] ECR 3883, 8 — Cf. Anicie 4(5) and (6) of Directive 65/65. at pp. 3908-3910.

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25. However, it does not necessarily follow that the composition of a medicinal product to combat influenza is potentially more harmful than that of a product to relieve 23. (bb) We now come to the second pan sleep disturbances of the kind described. of the definition, which is of interest in the That reveals, as far as the potential harm­ present case, and its relationship with the fulness aspect is concerned, one reason for characteristics of harmfulness and thera­ peutic efficacy, to which I have referred separating the concept of 'medicinal above. product' from that of disease: consumers desire, and manufacturers produce, prep­ arations which make it possible to be 'more' 10 — Cf. the Opinion of Mrs Advocate General Rozes, cued above, p 391Į than 'just' healthy. If we assume, as the

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OPINION OF MR LENZ — CASE C-l 12/69

28. A third reason for separating the two concepts is to be found, in my view, in a group of products which perform certain 26. A second reason, linked with the ancillary functions in a medical context, foregoing considerations, for holding that, although they are not of direct use for as regards the harmfulness aspect, the treating or preventing disease. They include, concept of medicinal product should be inter alia, narcotics, mentioned in Article 16 separated from that of disease, is to be of the directive as proprietary medicinal found in the many difficulties which may be products, which may also be regarded as encountered in defining the limits of the potentially harmful. latter concept. The type of case which immediately springs to mind is one in which physiological functions or manifestations present in all human beings (among others, heartbeat, blood pressure, blood supply to organs and glandular function) may be at 29. To recapitulate, it may be concluded any point on the scale between the healthy that having regard to the harmfulness aspect n and the pathological. The boundary in Article 5 of Directive 65/65 a product between (still) 'healthy' and (already) cannot justifiably be excluded from the 'diseased' is not always obvious. It is often concept of medicinal product merely not immediately possible to determine because it is not for treating or preventing whether a product capable in such cases of disease, since the fact that a product is for correcting an impairment up to a certain treating or preventing disease does not rule degree but not covering the whole range of out the necessity of testing its physiological the disease, including the most serious effects in the interests of public health forms, is a product for treating disease. That before it is placed on the market.

30. The Court of Justice appears also to protection, need not therefore be dealt with have taken that approach in its judgment in in any greater detail for the purposes of the van Bennekom, where it had to elaborate first question. I shall return to it in my criteria for drawing a distinction between discussion of the second question. foodstuffs and medicinal products within the meaning of the second part of the Community definition. Although that case concerned vitamin preparations which could 33. (b) As regards the second objective of be classified either as foodstuffs or as Directive 65 / 65 , namely the facilitation of medicinal products used 'for therapeutic l4 trade in proprietary medicinal products, it purposes in combating certain disease/, may be seen from the van Bennekom the Court did not choose to base the judgment that recourse to Article 36 of the distinction on that latter concept, but ruled: EEC Treaty is not ruled out by the existence of directives on pharmaceutical products, since the harmonization for which 16 they provide is not complete. That fact is 'The classification of a vitamin as a relevant especially where a product which is medicinal product within the meaning of the not a medicinal product (or, therefore, a second part of the definition in Directive proprietary medicinal product) within the 65/65 must be carried out case by case, meaning of Community law none the less having regard to the pharmacological prop­ constitutes such a product under national erties of each of them, to the extent to law and is thus subject (under national law) which they have been established in the 17 to an authorization requirement. It is clear present state of scientific knowledge.' that any dilution of the Community law concept of medicinal product such as would be entailed by the defendant's arguments, calling into question — as we have 31. The concept of 'pharmacology' is seen — the essential interests of the defined as relating to the nature and protection of health, would encourage the composition of chemical substances and development of differences between national 15 their effect on the body. That is consistent rules. The resulting obstacles — in so far as with the above considerations, concentrating they are not precluded by Articles 30 and 36 for the interpretation of the second part of of the EEC Treaty — run contrary to the the definition on the (potentially harmful) directive's aim of facilitating inter-State effects of a product rather than on an trade in medicinal products. assessment of the physical condition consti­ tuting the cause for the medication.

medicinal products, namely foodstuffs groups of products are specifically to be (within the meaning of Community law). excluded, in accordance with the third Where, however, the product in question, if recital in the preamble to the directive, from not classified as a medicinal product, falls the concept of medicinal product. However, within the scope of the aforementioned the question of the delimiting criteria to be directive on cosmetic products, as is taken into consideration here extends conceivable in the present case, then the beyond the framework of the national means of excluding free movement of goods court's first question, which concerns only available to Member States are subject to the specific problem of whether the concept even stricter provisions than under Article of disease is an appropriate delimiting 36 (see Anieles 12 and 13 of the directive). criterion. The fact that it is not does not We must not, however, lose sight of the fact mean, contrary to the defendant's view, that that Directives 65/65 and 76/768 each seek, the concept of medicinal product is in areas of divergent sensitivity, to reconcile extended unreasonably but merely that the the requirements of health protection and delimiting criteria must be established in the free movement of goods. Where the another way — which is the subject-matter properties of a product require, on grounds of the second question. connected with health protection, that it should be made subject to the authorization requirement under the rules on medicinal products and that the principle of free movement of goods should thus necessarily 36. III. All the above considerations lead me be curtailed, it is in my view unwarrantable, to propose that the Hoge Raad's first in pursuance of that principle, to subject the question should be answered as follows: product to another set of rules (namely those applicable to cosmetic products) the essence and purpose of which emphasize other aspects. 'The fact that a product is not for treating or preventing disease in human beings or animals within the meaning of the first part of the definition set out in Article 1(2) of Directive 65/65 does not preclude its administration to human beings with a view 35. II. While I thus propose that the Court to restoring, correcting or modifying physio­ should follow in principle the plaintiff, the logical functions and, therefore, its being a Commission and the Member States which medicinal product within the meaning of have submitted observations when that directive.' answering the Hoge Raad's first question, there can be no question of extending indef­ initely the concept of medicinal product. The defendant rightly points out that the The second question second part of the definition in Directive 65/65 is couched in extremely broad terms, particularly in its reference to 'modifying physiological function in human beings'. That wording obviously covers foodstuffs 37. 1.1 In referring to delimiting the and perhaps also cosmetic products (which concepts of 'medicinal product' and Directive 65/65 describes, in the possibly 'cosmetic product', the national court is somewhat too narrow language of the day, obviously assuming that the conditions set as 'toilet preparations'), although both those out in the terms of each definition are met.

40. (a) The question whether such over­ lapping is conceivable between the first part of the definition of a medicinal product (the 38. The hypothesis on which the national 'presentation criterion') and the definition court's second question is based, namely of a cosmetic product and, if so, what that the two definitions can be (and in the consequences that might entail may be left present case do) overlap, is at first sight open, since the Hoge Raad is manifestly surprising. A definition should, by its very concerned only with the delimitation of the nature, clearly and unambiguously indicate second part of the definition of a medicinal the boundaries of a concept— and thus the product, as may be seen from the way in scope of the rules attaching to it. The fifth which its two questions relate to each other. recital in the preamble to Directive 76/768 explicitly acknowledges, however, just such a possibility of overlapping. The recital begins, in its first and second clauses, by emphasizing that it is necessary to exclude medicinal products and proprietary 8 medicinal products ' from the scope of the 41. (b) It is obvious, in my view, that the directive by separating cosmetic products second part of the definition in Directive from medicinal products, and indicates in its 65/65 (leaving aside the alternative of third clause that such a delimitation follows 'making a medical diagnosis', which is not 'in particular' (and thus not exclusively) relevant here) may overlap with the def­ from the definition of cosmetic products. inition of a cosmetic product. The definition The fourth clause immediately goes on to of a cosmetic product refers only to the state: application of the product to certain — external — parts of the body. Here, the delimitation between cosmetic and medicinal products is relatively clear, and there can be no question of overlapping if the product is for application to other parts of the body — broadly speaking, for 9 internal use. ' If, however, as in the present 'this directive is not applicable to the case, it is for external application products that fall under the definition of (application 'on the body', in a literal trans­ cosmetic product but are exclusively lation of the German version of Article 1(2) intended to protect from disease'. of Directive 65/65), then the two definitions may overlap as regards that point, so the 18 — Like the German text, [he English text of Directive 76/768 delimitation must be derived from the differs from that of Directive 65/65 in that it refers to 'pharmaceuticals' rather than 'medicinal products' and to purpose of the application. 'pharmaceutical specialities' rather than 'proprietary medicinal products' But that is to be regarded as a mere terminological variation, 1 consider the content of the 19 — Sec also the clarifications in the fifth clause in the fifth concepts to be identical in both cases recital in the preamble to Directive 76/768

42. As regards that purpose, however, it by constricting them, which is relevant for must be noted that the concepts of the purposes of the definition in Directive 'restoring, correcting or modifying physio 65/65, but they also have an effect on body logical functions in human beings or in odours, thus meeting the criteria of Article 1 animals' are not inherently limited, and that of Directive 76/768. the definition of cosmetic products does not refer to those concepts to distinguish them from medicinal products, but introduces its own concepts, which are not compared with those of Directive 65/65 ('cleaning' the specified parts of the body, 'perfuming them 45.

43. Examples of cases where the definitions overlap are to be found in Annex I to Directive 76/768. For instance, depilatories, the eighth item on that list, may modify not only hair stability by their chemical effects on body hair but also skin function. They 46. 1. The parties to the main proceedings thus fall both within the second part of the and those who have submitted observations definition of medicinal product and under have proposed two alternative solutions to Article 1 (2) read in conjunction with Article this problem. In the defendant's view, when 1(1) ('change their appearance') of Directive the definitions overlap, it is generally to be 76/768. assumed that the product is a cosmetic

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20 cosmetic product. I endorse that view. 76/768. To take any other approach would be to disregard not only those objectives but also the demarcation of the roles played by the two directives with regard to the protection of public health. The delimitation between medicinal products and cosmetic products may therefore take the definition of a cosmetic product as its starting point 47. The basis for the considerations is the only if such an approach will ensure that all practical effect of the two directives in issue. products which must, in view of the That can best be taken into account by objectives of Directive 65 / 65 , be governed defining the scope of each measure in by that directive do actually fall within its accordance with its respective objectives. I scope. If not, the starting point for that have already pointed out that both directives delimitation must be the definition in are intended to reconcile the aspects of free Directive 65 / 65 , the precise meaning of movement of goods and protection of which must be ascertained by interpretation health in areas of divergent sensitivity. where appropriate. Protection of health is the primary objective

That in Other considerations apply to the products listed in Annex I to the directive, to which Article \(2) refers. If a product dication links up with the consideration corresponds to one of the alternatives listed, it is estab- lished as being a cosmetic product. That annex is, however, already mentioned that overlapping of the also relevant to the delimitation where the product in issue two definitions concerned is possible does noi correspond to any of the alternatives listed in it, thus limning the primacy of the definition of medicinal precisely because the terms of Directive product to a certain extent in that respect. I shall return to 76/768, which outline the purpose of the this question (point 77). product, do not make it possible to draw 11 — Src the first recital in the preamble to Directive 65/65 and ihc third recital in the preamble to Directive 76/768. any definitive conclusion as to the effects

produced by the product in the fulfilment of referred to therein and cannot be gener­ its cosmetic purpose. It is clear that a alized. At the hearing, the further question product for 'protecting' the skin, for arose whether the word 'exclusively' used in example, in order to keep it 'in good that indication militated against such a condition' is not a cosmetic product if it is generalization. 'exclusively intended to protect from disease'. One point is thus established, namely that at least in this specific case the definition of a medicinal product prevails 52. As far as that question is concerned, over the definition of a cosmetic first of all, I consider that the word 'exclu­ product — in other words, in this case of sively' relates, in the context of the wording overlapping, the definition of a cosmetic chosen, only to the purpose of the product product is not sufficient to ensure that all ('exclusively intended to protect from products which should in accordance with disease') and has nothing to do with the the meaning and purpose of Directive 65/65 problem of whether the definition of a be classified as medicinal products are in medicinal product is to prevail only in such fact so classified. a case. Because of that more general problem, it is significant that, apparently quite consciously, the authors of the directive did not take the opportunity of introducing conclusive criteria for the delimitation of the products which it concerned from medicinal products 50. Unlike the United Kingdom, I do not — criteria which could have taken account believe that the phrase cited from the fifth of the requirements of Directive 65/65. Had recital refers to the first part of the def­ that been intended, such criteria would have inition of a medicinal product. It relates not had their place not in the preamble but in 22 23 to the presentation but to the purpose of the text of the directive itself; however, as I the product. That is also — with all the have said, it may be seen from the third and differences between the various language fourth clauses in the fifth recital that they versions — the basis for the second part of are not contained in the text. the definition of a medicinal product. It is known from the van Bennekom judgment that a product for preventing disease (that is to say, a product which actually possesses 53. A preamble, however, may not and such properties) is to be classified, cannot replace a Community legislative text; regardless of its presentation, as a medicinal its role is merely to clarify an existing text. product within the meaning of the second Such clarification (cf. Article 190 of the 24 part of Article 1(2) of Directive 65/65. EEC Treaty) need not be exhaustive but may confine itself to the basic features of 25 the measure. The fact that no attempt was to be made in the fifth recital in the preamble to Directive 76/768 to make a conclusive delimitation is also clear from the arrangement of the third, fourth and fifth 51. However, the defendant considers that clauses in that recital. The third clause, by the abovementioned indication derived from its use of the term 'in particular', shows that the fifth recital is relevant only to the case the definition of a cosmetic product does

not contain all the details required for the such products fall within the definition of a delimitation. The fourth and fifth clauses medicinal product — inasmuch as they are not, however, logically devoted to the influence a skin function (the repeated details still lacking, but deal with two desquamation of the outermost layer) — but borderline cases. In the opinion of the also within the definition of a cosmetic authors of the directive, the first of those product — inasmuch as they are intended to

54. Evidence is also to be found in Annex I conclusion must be maintained that the def to Directive 76/768 to support the inition in that directive does not, in the conclusion that the fourth clause in the fifth event of overlapping, provide sufficient recital does not necessarily constitute the criteria to ensure that all products which sole case of overlapping in which the def must, in accordance with the meaning and inition of a medicinal product prevails over purpose of Directive 65/65, be classified as that of a cosmetic product. The second item medicinal products are actually so classified. on the list contained in that annex gives as In that case, the delimitation is to be an example the following type of cosmetic operated in such a way that the definition of product: 'Face masks (with the exception of a medicinal product prevails over that of a

. . or with the teeth and mucous afforded by the substances dissolving hard skin, which are membranes of the oral cavity' (Article I) does not cover also contained in products for the treatment of corns or cases where the producu in question are intended to be acne; for peeling producu, the possible harmful effects of 'ingested, inhaled, injected or implanted in the human contact with the eyes, which is difficult to prevent even body' when correctly applied, must apparently also be taken into 28 — Emphasis added consideration.

'A product which is not presented for 59. (a) Once again, we should begin with treating or preventing disease in human the protection of public health, which is the beings or animals and which, although not primary objective, covering protection mentioned as being a cosmetic product in against harmful and therapeutically inef­ Annex I to Directive 76/768, would fective products. constitute a cosmetic product under Article 1(1) of Directive 76/768 must nevertheless not be classed as such a product but as a medicinal product within the meaning of 60. (aa) As far as the aspect of harmfulness Directive 65/65 if it may be administered to is concerned, it is possible to draw, as the human beings with a view to restoring, plaintiff and the Italian Government do, a correcting or modifying physiological parallel with the judgment in the van functions.' Bennekom case, cited above. In that judgment, having regard to the fact that overconsumption of vitamins may be harmful to human health, the Court made the classification of such vitamins under the 57. 2. That decision raises, as has rightly second part of the definition of a medicinal been pointed out by the plaintiff, the United product dependent on the 'pharmacological Kingdom and the Italian Government, the properties' of the product, 'to the extent to question of a more precise delimitation of which they have been established in the the concept of medicinal product derived present state of scientific knowledge', thus, from the second part of the definition in as I have stated, basing its reasoning on the Directive 65/65 (leaving aside the question physiological effects of the product. That of 'making a medical diagnosis', with which approach is correct, as may be seen, in the we are not concerned here). By that inter­ first place, from my considerations pretation, the part of the definition of regarding the first question. Furthermore, it medicinal product which is applicable here constitutes the link between the terms used must be confined to what is necessary in in the second part of the definition of a view of the objectives of the directive. All medicinal product (restoring, correcting or products which on the basis of that interpre­ modifying physiological functions) and the tation do not, or no longer, fall within the concept of harmfulness. All refer to the definition of a medicinal product but do physiological effects of the product in meet the conditions of the definition of a question. However, whereas the terms used cosmetic product, are to be classified as in the definition cover all effects — however cosmetic products. Products which are, in minimal — the concept of 'harmfulness' the light of that interpretation, medicinal refers only to certain specifically negative products within the meaning of the def­ effects. inition in Directive 65/65, on the other hand, can be classified only as medicinal products and not as cosmetic products. 61. The answer to the Hoge Raad's second question should therefore establish the following principle:

63. (1) First of all, it is necessary to reply to an argument of the French Government, which wishes to classify the product in issue as a medicinal product on the ground, inter Observed when the product is administered alia, that if it is ingested (a possibility which to the proper part of the human body'. cannot be ruled out, in particular in the case of children) untoward effects on health might ensue. As the defendant rightly points out, the only effects to be considered are 65. (2) Furthermore, it is also necessary in those which the product has when applied my opinion to specify the quality which to the part of the body to which, in the those properties must possess to enable the judgment of the average user, it is to be product in question to be regarded as a administered (which may be clear from the medicinal product within the meaning of the manufacturer's instructions) (hereinafter part of the definition under consideration. referred to as 'the proper place' of adminis­ tration). That limitation is clear, in the first place, from the wording of the second part of the definition in Directive 65/65, which 66. In the view of the Italian Government, focuses on the administration of the in the relationship between medicinal product, that is to say an act whereby its products and cosmetic products all products specific properties are to be intentionally which modify physiological functions are rendered operative. There can, however, be medicinal products unless, despite that no question that a product is administered effect, the directive on cosmetic products if, contrary to its intended purpose explicitly (in Annex I) classifies the product — accidentally, for example — it is applied in question as a cosmetic product. It cites to a pan of the human body other than that the examples of anti-perspirants and for which it is destined. That approach is products for tanning without sun. I do not borne out by Article 5 of the directive, believe, however, that such an approach under which authorization to market the makes it possible to reach an adequate product is to. be refused if it is harmful 'in solution in the present case. Generally 30 the normal conditions of use'. Effects speaking, Annex I to Directive 76/768, which contains an 'illustrative list', has the 30 — Thai expression has, however, a rather wider meaning sole function of specifying that the items on than lhe criterion of the proper place of application to be that list are cosmetic products. It is not, borne in mind here. It also covers, in particular, the frequency and duration of the administration. however, intended to establish that products

not listed do not possess that quality. The 68. Two grounds support that criterion. significance for the problem raised in the First, it is manifestly in harmony with the present case is that if a product modifies meaning and purpose of the directive, in so physiological functions and corresponds to far as the latter serves to protect public one of the possibilities listed in Annex I, health and in that respect contains rules to then it is a cosmetic product. If, however, it prevent harmful medicinal products from does not correspond to any of those alter­ reaching the consumer. Secondly, it is natives, the converse may not be concluded. consistent with the wording of the relevant That consequence, drawn from general part of the definition of medicinal product, considerations on the nature of the annex, which concentrates on the effects of the seems to me to be particularly justified by product; those effects are more precisely the fact that the authors of the directive defined — from the point of view of harm- listed the products in the annex 'by fulness — without laying down any further category', in order to convey the clearest conditions. possible impression of the possibilities. They were not concerned, as may be seen from the mention of creams and powders, with designating specifically the difficult cases. Moreover, I would not wish to rule out the possibility that many products listed in 69. In the same context, I should like to Annex I but not mentioned by the Italian reject the plaintiff's view that in the absence Government can modify — even to a totally of pharmacological properties (as thus insignificant extent — physiological defined) the product in question never­ functions. All the above should lend support theless constitutes a medicinal product if the to the 'case-by-case' approach decided upon authorities of other Member States have by the Court in the van Bennekom case. classified it as such. In the first place, the directive does not provide that the auth­ orities of Member States must be guided by the decisions of the authorities of other Member States. Each authority makes its own independent appraisal, which cannot thus be replaced by a decision of another authority. Furthermore, as I have already pointed out, according to the Court's case-law the concept of a medicinal product in national law may encompass more products than the Community law concept 67. The United Kingdom proposal, with without thereby infringing Community which I wish to concur, derives from the law. 32 same consideration. In the United Kingdom's view, the conditions of the part of the definition of a medicinal product with which we are concerned here are fulfilled whenever the product interferes with physio­ logical functions in an exceptional manner and thus constitutes a sufficient risk to 70. It thus follows that the answer to the public health to justify the application of the second question must include the following authorization system under Directive 65/65. statement, clarifying the ruling in van Bennekom: 51 — The peeling products mentioned in the second item on the list constitute an exception. 32 — See footnote 17.

72. (a) The parties disputed before the 74. (b) Thus, the fact that the prohibition of Court the significance in that connection of specific substances under the directive on an adapting directive of the Commission, cosmetic products gives no indication as Directive 87/137/EEC. » Under that regards the classification of a product does directive, the use of minoxidil or its salts or not mean that such indications are derivatives in cosmetic products is completely lacking. If it is doubtful whether prohibited and products containing such the properties of a product qualify it as a substances may no longer be placed on the medicinal product in the light of the market after 1 January 1989 or sold or criterion elaborated above, it may be helpful disposed of to the final consumer after for national authorities or national courts to 31 December 1990 (see Article 1(1) in compare those properties with the properties conjunction with Article 2 of the adapting of other products whose classification as directive). The plaintiff would conclude medicinal products or as cosmetic products from that prohibition — introduced into is clear from that criterion. Here again, it is Annex II to Directive 76/768 — of necessary to proceed on a 'case-by-case' minoxidil in cosmetic products that the basis. product under consideration is a medicinal product; the defendant would draw the opposite conclusion. Neither is right.

75. (aa) First of all, as regards the utility of 33 — Ninth Commission Directive of I February 1987 adapting to technical progress Annexes !I, III, IV, V and VI to such an indication, I consider it important Council Direcme 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic to bear in mind that any criterion based on products (OJ 1987 L 56, p 20) an assessment of the effects of a product

raises a question of proportion. For the 77. (cc) The same consideration applies, criterion selected in this case, it might thus basically, with regard to products whose be asked: how is it possible to assess status as cosmetic products is established. If whether the effect of a product (already) matters are regarded solely from the point possesses that quality which makes it excep­ of view of Directive 65/65, it might be tional and requires the application of the concluded from the third recital in the authorization procedure under Directive preamble that the Community legislator is 65/65 or whether it (still) does not reach assuming a central core of cosmetic 35 that limit? Such an assessment requires, products established as such by general especially in borderline cases, a point of acceptance and that such reference the determination of which is thus products — alongside those whose status as no mere academic exercise. medicinal products is clear from the considerations expounded above — may be used as further standards of comparison. Such a premiss is correct in principle. Super­ imposed upon it, however, is the legislative decision set out in Annex I to Directive 76/768 a list of examples of products whose status as cosmetic products is established. That annex covers a large proportion of the products to which the abovementioned general acceptance applies, and thus provides a codification in their regard; 76. (bb) For that purpose it is possible, first however, in so far as that codification of all, to make a comparison with other extends beyond that general acceptance, the products whose classification as medicinal fact that a product is listed therein estab­ products is established because of their lishes its status as a cosmetic product. Thus, pharmacological properties. As is suggested the first products to be taken as standards of by the broad terms of the part of the def­ comparison are those in Annex I to inition of a medicinal product under Directive 76/768. However, reference consideration, the authors thereof should also be made to products which are apparently assumed that the pharmaco­ not listed in that directive but are by general logical properties of individual products acceptance classed as cosmetic products on self-evidently qualified them as medicinal account of their properties. products without any need for further explanation because they are generally 34 accepted as such. That is expressed, for instance, in Articles 6 and 16 of Directive 65/65, in which contraceptives and 78. (dd) In the light of all of those narcotics are classed, without further expla­ considerations, I propose that the answer to nation, as medicinal products. Even if that the second question should include the central core of products whose status as following clarification: medicinal products is in no doubt cannot always be helpful as a standard of comparison where preparations with completely new effects are concerned, such a comparison should nevertheless at least facilitate classification for most products. 'For the purpose of this assessment, as far as possible the pharmacological properties of 34 — See also the third recital in the preamble to Directive 65/65. 35 — See point 35 above.

81. I should like to propose a discriminating 79. (cc) So far, the considerations relating solution. In principle, verification of thera­ to delimiting medicinal products from peutic efficacy should prevent a consumer cosmetic products have concerned, in so far from using inappropriate medicinal products as Directive 65/65 seeks the protection of in the event of the onset or threat of a public health, protection against potentially disease and the prevention or treatment harmful proprietary medicinal products. It thereof from being jeopardized or even may therefore justifiably be asked whether, frustrated. Such an approach is supported, from the point of view of therapeutic first, by the application of the concept of efficacy, other considerations must also be 'therapeutic efficacy' which, by definition, taken into account when choosing the presupposes a disease and, secondly, by the criterion for delimitation. The view might be fact that the authors of the directive taken that protection against ineffective explicitly formulated the definition of a proprietary medicinal products is ensured medicinal product in terms of a criterion of only if it is enough that pharmacological description only with reference to properties which classify a product, in 'substances presented for treating or accordance with the abovementioned preventing disease in human beings or criterion, as a medicinal product are merely animals'. Medicinal products not presented claimed by the manufacturer (but are not for that purpose, however, cannot give rise actually present). Under that interpretation, to the risk which that machinery strives to the part of the definition of a medicinal counteract. The fact that a hair restorer product at present under consideration such as that in issue in the present would be not only a criterion of application proceedings, for example, is ineffective does (which it must in any event be in the light of not constitute a danger to public health. the above considerations concerning protection against harmful proprietary medicinal products) but also a criterion of description, like the first part of the def­ 82. In the case of certain other products, inition of a medicinal product. however, which fall within the second part of the definition of a medicinal product, the fact that they are ineffective does indeed constitute a danger to public health, as is 36 demonstrated by the Tissier case, with regard, for example, to diagnostic products. 80. The plaintiff appears to be advocating For the purposes of the alternative part of such a solution. It would indeed also be consistent with the wording of the second 36 — See (he judgment in 7'usicr, paragraph 27

C — Conclusion

86. On the basis of all the foregoing considerations, I propose that the Hoge Raad's question should be answered as follows:

'(1) The fact that a product is not presented for treating or preventing disease in human beings or animals within the meaning of the first part of the definition set out in Article 1(2) of Directive 65 / 65 does not preclude its being admin­ istered to human beings with a view to restoring , correcting or modifying physiological functions and , therefore, its being a medicinal product within the meaning of that directive.

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(2) (a) A product which is not presented for treating or preventing disease in human beings or animals and which, although not mentioned as being a cosmetic product in Annex I to Directive 76/768, constitutes a cosmetic product by virtue of Article 1(1) of Directive 76/768 must nevertheless not be classed as such a product but as a medicinal product within the meaning of Directive 65/65 if it may be administered to human beings with a view to restoring, correcting or modifying physiological functions.

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