C-290/90

O P I N I O N OF M R VAN GERVEN — CASE C-290/90

OPINION OF ADVOCATE GENERAL VAN GERVEN delivered on 13 March 1992 *

Mr President, measure having equivalent effect which is Members of the Court, prohibited by Article 30 of the EEC Treaty. The Commission further maintains — con- trary to the German Government's alterna- tive contention, put forward in the event that the eye lotions are deemed not to constitute 1. This case is concerned with an action medicinal products — that a requirement of brought by the Commission against the Fed- authorization cannot be justified on grounds eral Republic of Germany on the basis of of the protection of health under Article Article 169 of the EEC Treaty. The central 36 of the EEC Treaty. issue in this case is whether the eye lotions produced by the French firm Prevor ' are medicinal products within the meaning of Article 1 of Directive 65/65/EEC. 2 The Ger- The relevant Community legislation and man Government considers that they are and case-law further contends that — as Article 21 of the Arzneimittelgesetz (German Law on Medici- nal Products) provides in accordance with Article 3 of the aforesaid directive — those 2. Article 3 of Directive 65/65, in the version products may be placed on the market in which was in force at the material time, 3 Germany only if a prior authorization has provides as follows: been issued by the competent German authority. However, the Commission takes the view that the products concerned d o not ' N o proprietary medicinal product may be constitute medicinal products and that the placed on the market in a Member State requirement of authorization constitutes a unless an authorization has been issued by the competent authority of that Member State.'

The first subparagraph of Article 1 (2) of the directive defines a medicinal product as:

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O P I N I O N OF MR VAN GERVEN — CASE C-290/90

products within the meaning of the second cannot be the sole or conclusive premise (functional) definition. I 0 'since otherwise certain food products which are traditionally presented in a similar form to pharmaceutical products would also be covered'. 15

10 — See, for instance, the judgment in Van Bennekom, cited in footnote 8, paragraph 22. 15 — See the judgment in Van Bennekom, cited in footnote 8, 11 — Ibid., paragraph 18. paragraph 19, and the judgment in DeUttre, cited in foot- 12 — Ibid., paragraph 19. note 6, paragraph 38. 13 — See the judgments in Monteil and Samanni and Delattre, 16 -— See the judgment in Upjohn, cited in footnote 6, paragraph cited in footnote 6, paragraphs 24 and 40 respectively. 17. 14 — See the judgment in Delattre, cited in footnote 6, paragraph 17 — Ibid., paragraph 21. 41. 18 — Ibid-, paragraph 22.

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COMMISSION v GERMANY

5. It is apparent from the recent case-law of the Court that in the first stage of the har- monization of national legislation as pro- vided for in Directive 65/65, a not inconsid- erable discretion is left to the Member States, with the result that differences may continue 6. Finally, let me also point out that this case to exist as between Member States with is concerned only with eye lotions which are regard to the classification of products. intended to be used where by mischance a Hence it is conceivable that a product classi- harmful substance (acid or alkaline) finds its fied as a foodstuff in one Member State, may way into the eye. The lotions must then be be treated as a medicinal product in anoth- applied as quickly as possible, in which case er. 20 they absorb the substance (by means of an acid/alkaline reaction) and remove it by rins-

The wrongly treating the eye lotions in question Commission disputes that. I shall now con- as medicinal products. Of course, this does sider whether the eye lotions come within not preclude the Member State concerned the 'functional' definition, and only thereaf- from having to cooperate in the production ter whether they come within the definition of evidence by plausibly demonstrating, as relating to 'presentation'. This order strikes me as more logical than that followed in Article 1(2) of the directive: in order to ascertain whether a product is presented as a 19 — Ibid., paragraph 23, and the judgment in Monteil and medicinal product, it is necessary to establish Samanni, cited in footnote 6, paragraph 30. 20 — See the judgments in Delattre and Monteil and Samanni, what is meant by medicinal product first. cited in footnote 6, paragraphs 26 to 29. 21 — See, for instance, the judgment in Case 97/81 Commission v Netherlands [1982] ECR 1819, paragraph 6, the judgment in Case 323/87 Commission v Italy [1989] ECR 2275, para- graph 19, and the judgment in Case 290/87 in Commission 22 — See the judgment in Defottre, cited in footnote 6, paragraph v Netherlands [1989] ECR 3083, paragraph 11. 32.

The 'functional' definition the 'functional' Community definition, the decisive criterion is the way in which the substance works. If the action of a product is purely mechanical (as is the case of plaster or a splint), or is very diffuse and feeble (as is the case of salts for foot baths or herbal 7. As stated earlier, the German Govern- sweets), then it is not a medicinal product. ment takes the view that the eye lotions pro- duced by Prevor constitute medicinal prod- ucts for the purposes of the second, that is to say 'functional', Community definition. It submits that the European Pharmacopoeia Commission of the Council of Europe regards eye lotions as medicinal products, 2 i Moreover, according to the Commission, which is significant since, according to the products whose composition is identical to case-law of the Court, the Member States are that of eye lotions but which are used on the required in connection with the classification skin instead of the eyes are cosmetic not of a product as a medicinal product to take medicinal products. Why then should eye account of the results of international scien- lotions with the same composition constitute tific research and, in particular, the findings medicinal products? The German Govern- of specialized committees operating at a ment, however, disagrees with that argument. Community (or comparable) level. 24 According to the case-law of the Court, account must also be taken of the manner in which the product is used and it is therefore justified to draw a distinction between a product used on the skin and one used on the eyes, even though there is no difference In its application the Commission acknowl- in composition. edges that if the definition in question is construed literally, it is hard to deny that eye lotions serve to restore, correct or modify a physiological function, namely eyesight. In its view, such a literal interpretation is incor- rect, however, because it disregards the fact that the concept of medicinal product, not- withstanding the need acknowledged by the 8. The arguments regarding the 'functional' Court for a wide interpretation, must be definition revolve essentially around the restricted in the light of the aim of protecting question whether the eye lotions in question public health. Products which have no effect are merely cleansing agents, or are more far as medicinal products must therefore be reaching in their effects. According to the excluded, even though they have a medical Commission, the lotions concerned merely or even a clinical purpose. So far as concerns cleanse the eyes simply by the mechanical process of rinsing them. However, they lack the property of restoring or correcting the mobility of the eye or eyesight where it is 23 — See the definitive version (January 1991) of the heading 'Solutiones Ophthalmicae' in the European Pharmacopoeia, affected by a harmful substance which has Annex II attached to the rejoinder. found its way into the eye. Eye lotions have 24 — See the judgment in Delattre-, cited in footnote 6, paragraph 32. See also paragraph 5 above. only a superficial effect, that is to say during

The German Government does not deny that an eye attacked by an acid or alkaline Admittedly, the Commission is right in calls for specialized medical treatment. How- claiming that the discretion left to the Mem- ever, it does dispute the view that a harmful ber States must be exercised within reason- substance which comes into contact with the able limits and that compliance with those eye penetrates inside the eye after only a few limits must be subject to some measure of minutes and it maintains, moreover, that judicial review. In order to enable such a treatment already begins with the application review to be carried out, however, the Com- of the eye lotions which, owing to their spe- mission, which bears the onus of proof (see cial chemical composition and in contrast to paragraph 5 above), must, albeit on the basis water for instance, are capable — as the of the internationally recognized results of Commission also acknowledges — of scientific research, plausibly demonstrate absorbing the harmful substance. According that the Member State's decision to treat a to the German Government, absorption (or product as a medicinal product cannot be neutralization) occurs not only on the sur- justified. A mere reference to the attitude of face of the eye but also through the upper the competent authorities of other Member layers of the cornea and the connective tis- States with regard to the product con- sue, as well as through the epithelium and cerned 27 is not decisive in itself since the the corneal stroma. In support of that asser- Court accepts (see paragraph 5 above) that, tion, it refers to a scientific study concerning at the present stage of harmonization, differ- the prevention of corneal ulcers, 25 which ences in classification may continue to exist states that an eye lotion containing EDTA, as between the Member States. the substance of which 'Previn' is also largely composed, has therapeutic properties and, more specifically, prevents the develop- 26 — At the hearing the Commission belatedly referred to a ment of corneal ulcers. study carried out by a French institution, which postdates the Court's judgment in Upjohn and consequently the expiry of the period material to this case (see footnote 2). 27 — It is not clear from the documents before the Court pre- cisely what requirements other Member States impose for the marketing of eye lotions. The scant data provided by 25 — Slansky H. et al, 'Prevention of Corneal Ulcers', Tr. Am. the Commission in that regard were contested by the Ger- Acad. Ophth. OtoL Vol. 75, (Nov-Dec 1971) p. 1208. man Government at the hearing.

I have therefore come to the conclusion that which they penetrate the eye ... Those the Commission has failed to demonstrate to lotions serve to rinse the eye and remove a sufficient extent that, by treating the eye corrosive products.' lotions in question as medicinal products, the German Government has misapplied the sec- ond subparagraph of Article 1(2) of Direc- tive 65/65. I share the Commission's view that in that passage Prevor does not expressly state that the eye lotions in question have therapeutic or prophylactic properties. The same must The definition relating to 'presentation' be said, in my view, of the document from Prevor, constituting Annex 2 to the German Government's rejoinder, which gives a graphic description of the pharmacological effect of 'Previn' eye lotion (and which, according to the German Government, 10. Having come to the conclusion that the forms part of a publicity leaflet for 'Previn'). Commission has failed to demonstrate that Germany was wrong to regard the eye lotions in question as medicinal products for the purposes of the 'functional' definition and since, as stated earlier, a product consti- tutes a medicinal product if it is covered by 11. Nor, it seems to me after inspecting the one or other of the two definitions, I need eye lotions in question at the hearing, can it not dwell on the question whether those be said that they convey to the average con- lotions constitute medicinal products for the sumer the impression 'which, provided it is purposes of the definition relating to 'pre- definite, may even result from implication' 28 sentation'. In that connection, the German that they have a therapeutic or prophylactic Government maintains that, in its publicity effect. The external form and packaging of leaflets, Prevor describes the eye lotions as the eye lotions in question, and the publicity products for treating burns in the eye. leaflets distributed by Prevor, certainly do According to the Commission, that is incor- not convey that impression. Besides, that cri- rect and the publicity leaflets describe only terion must be applied with care, otherwise it the cleansing effect of the lotion. would be only too easy for a producer to present a product as a medicinal product, resulting in its withdrawal (unless authoriza- tion is granted) from the free movement of goods.

The Commission was therefore right in con- cluding that the eye lotions in question could not be treated by the Federal Republic of Germany as medicinal products within the meaning of the first subparagraph of Article 1(2) of the directive. According to the German Government, the eye lotions in question may constitute a dan- ger for public health, for instance if they are insufficiendy effective or of inferior quality, and thereby fail to prevent serious injury to The alternative contention: Article 36 of the the eye or even cause the loss of an eye. Fur- EEC Treaty thermore, all the eye lotions at issue in this case are placed on the market in multi-dose bottles, which means that a preservative has 12. Should the Court consider that, contrary to be added to the product and if the latter is to the view which I have taken, the Commis- used on an injured eye, the healing process sion has successfully demonstrated that the may be delayed or even hindered. For that eye lotions in question do not constitute reason, the German (and also the European) medicinal products for the purposes of the Pharmacopoeia provides that eye lotions 'functional' definition and that, in keeping which are used in surgical procedures or by with my view, those lotions do not consti- way of first aid in the event of an accident tute medicinal products for the purposes of may be supplied in single-dose bottles. the definition relating to 'presentation' Moreover, none of the eye lotions in ques- either, then the requirement of a marketing tion seems to carry a use-by date, even authorization laid down by German law though the German Pharmacopoeia restricts would undoubtedly constitute a measure having equivalent effect which is prohibited by Article 30 of the EEC Treaty. The ques- tion then arises whether, as the German 29 — See the judgment in Tissier, cited in footnote 7, paragraph 22, and the judgment in Monteil and Samanni, cited in Government contends in the alternative, that footnote 6, paragraph 36.

14. Since I consider that the requirement of a marketing authorization is too restrictive a measure in every respect, I need not devote too much time to the Commission's argu- 13. It is not incorrect, in my view, to con- ment that such a requirement must in any sider that the eye lotions in question — event be regarded as constituting arbitrary which, in the hypothetical situation now discrimination within the meaning of the under consideration, are assumed not to con- second sentence of Article 36 of the EEC stitute medicinal products — may in certain Treaty. In the first place, it maintains, that circumstances be a danger to public health. requirement is not applied to certain eye However, the question is whether that dan- lotions produced in Germany. Secondly, a ger can be overcome by a measure which is less restrictive measure is applied in the case less restrictive of intra-Community trade of older eye lotions, that is to say lotions than the requirement of a marketing authori- sold before 1 January 1978. 'Old' products zation. In my view, it can. A less restrictive of that kind can be openly bought and sold if measure could, for instance, consist in an a marketing authorization was sought before obligation to notify the competent authori- 30 April 1990. ties (with supporting documents attached) who would be able to withdraw the product from the market in specified circumstances — according to the Commission, France has a system of that kind for the eye lotions in question — and/or in an obligation to pro- vide appropriate information, or even in the imposition of single-dose bottles to be used for certain purposes (for instance in surgical In my view those arguments are unfounded. operations or by way of first aid in the event So far as the first argument is concerned, the of an accident). German Government states that in the case of the aforesaid domestically-produced lotions, either an authorization was actually sought and obtained, or the administrative procedure laid down was set in motion as soon as the competent national authority was notified that the products had been placed on the market without authorization, Accordingly, it seems to me, the German an assertion which, so far as I have been able Government has failed to demonstrate that to ascertain, is not gainsaid by the docu-

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