C-219/91

Mr President, After being found guilty on that charge by Members of the Court, the Kantongerecht (Cantonal Court), Leeu- warden, Mr Ter Voort brought an appeal in the Arrondissementsrechtbank (District Court) in which he argued that the teas in 1. The questions referred to the Court for a question could not be regarded as medicinal preliminary ruling by the Arrondisse- products with the meaning of Directive mentsrechtbank (District Court), Leeuwar- 65/65. In order to establish whether the den (Netherlands), relate to the interpreta- products in question fall within the Commu- tion of the concept of medicinal products 'by nity definition of medicinal products, the virtue of their presentation' contained in the national court has therefore submitted four first subparagraph of Article 1(2) of Council questions to this court for a preliminary rul- Directive 65/65/EEC of 26 January 1965 on ing. the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products. ' 2. Before considering the individual ques- tions, it is appropriate to recall that Directive 65/65, whose aim is to eliminate hindrances to the free movement of medicinal products The questions were raised in criminal pro- and, at the same time, to safeguard public ceedings against Mr Ter Voort, who is health, requires Member States to subject to charged with having prepared, imported, prior authorization the placing of propri- held, sold and/or marketed unregistered etary medicinal products on the market medicinal products — more specifically, (Article 3). 2 'Proprietary medicinal product' herbal teas imported from South America is defined as 'any ready-prepared medicinal and sold by Mr Ter Voort, trading as 'Fitness product placed on the market under a special Foundation Nederland', at his place of resi- name and in a special pack'. dence — contrary to Article 3(5) of the Wet op de Geneesmiddelenvoorziening (Law on the Supply of Medicinal Products). Those For the purposes of the directive, a medicinal teas, which are not recommended or product is 'any substance or combination of described as medicinal products on the pack- substances presented for treating or prevent- aging, on the label or in the directions for ing disease in human beings or animals' (first use, are, however, presented as having thera- subparagraph of Article 1(2) — 'medicinal peutic properties by the foundation 'Stich- product by virtue of its presentation') or ting Nieuwe Horizon' in an explanatory 'any substance or combination of substances brochure sent to anyone on request.

which may be administered to human beings designed, as the Court explained in that or animals with a view to making a medical judgment, to cover not only medicinal prod- diagnosis or to restoring, correcting or mod- ucts having a genuine therapeutic or medical ifying physiological functions in human effect (which therefore are also caught by the beings or in animals' (second subparagraph definition of 'medicinal products by virtue of of Article 1(2) — 'medicinal product by vir- their function') but also those which are not tue of its function'). sufficiently effective or which do not have the effect which consumers would be entitled to expect in view of their presentation. The directive thereby seeks to preserve consum- ers not only from harmful or toxic medicinal The two definitions of 'medicinal product', products as such but also from a variety of as elucidated by the Court, 3 are not rigor- products represented as proper remedies — ously separate; in the case at issue, however, regardless of the fact that they are com- the national court's questions relate solely to pletely harmless. In sum, it seeks to safe- the concept of 'medicinal product by virtue guard against quackery. of its presentation': the national court con- siders it unquestionable that the herbal teas at issue have no therapeutic or prophylactic effects, at least in the present state of scien- tific knowledge. It follows that products presented as having therapeutic or prophylactic effects, albeit — according to the present state of scientific 3. The national court's first question seeks knowledge — completely lacking the proper- to establish whether a product presented as ties attributed to them, are medicinal prod- having curative or preventive properties falls ucts within the meaning of Directive within the definition in the first subpara- 65/65 and should therefore be subjected to graph of Article 1 (2) of Directive 65/65 even the system of prior authorization, precisely where, as in this case, the product in general to prevent their being placed on the market is regarded as a foodstuff and in accordance as 'medicinal products'. The fact that the with current scientific knowledge does not product at issue in this case is generally possess any pharmacological properties. regarded as a foodstuff does not detract from that conclusion in so far as it is in any event described or recommended as having thera- peutic or prophylactic effects. Consequently, the first question should be answered in the In that connection, I would observe in the affirmative. first place that, as from the judgment in Van Bennekom, the Court has held that 'the con- cept of the "presentation" of a product must be broadly construed'. 4 Through the crite- rion of presentation, Directive 65/65 is 4. The second and third questions are con- cerned with the type of connection which has exist between the product and its presen- 3 — See, most recently, the judgment in Case C-l 12/89 Upjohn [1991] E C R 1-1703, paragraph 18. tation in order for it to be caught by the def- 4 — Judgment in Case 227/82 Van Bennekom [1983] ECR 3883, inition of 'medicinal product by virtue of its paragraph 17; similarly, see, most recently, the judgment in Case C-112/89 Upjohn, cited above, paragraph 16. presentation' within the meaning of Direc-

tive 65/65. In particular, the national court the notice of potential consumers and thus asks whether it is relevant that the therapeu- influence the sale of the product on account tic properties of the product emerge solely of the therapeutic properties attributed to it from a publication sent on request by the in the publication in question. supplier or a third party after the product has been purchased. It also asks whether it is pertinent that the publication in question is made independently of the sale of the prod- uct and/or by a third party who is not the supplier or the seller, regard also being had to Article 10 of the European Convention on Indeed, since the concept of the 'presenta- Human Rights. tion' of a product must be interpreted broadly so as to cover all products presented as medicinal products — even if merely for commercial purposes —, it is conclusive that the product in question is 'presented' in such a way as to disclose the producer's or the I would observe in the first place that the supplier's intention to market it as a medici- fact that a product is not indicated or recom- nal product, thereby misleading consumers mended as a medicinal product in the about its real properties. instructions, on the label or on the pack is as such not conclusive for the purposes of cat- egorizing the product. In that connection, it is sufficient to recall that, as the Court has held, the definition of a medicinal product 'by virtue of presentation' also covers prod- ucts indicated or recommended as having It follows that a product presented as a therapeutic or prophylactic properties by medicinal product by means of a publication oral representation 5 and, more generally, all sent — albeit at the request of the consumer products which appear to the averagely well- himself — by the producer or supplier of the informed consumer in the light of their pre- product in question or even by a third party sentation to be medicinal products. 6 acting on their behalf falls within the Com- munity definition of a medicinal product by virtue of its presentation within the meaning of the first subparagraph of Article 1(2) of Directive 65/65. Neither does it appear to me to be of partic- ular relevance that the information about the therapeutic properties of the teas at issue is set out in a publication sent on the purchas- er's request after he has bought the product: manifesdy such information may come to 5. As for the possibility that the information about the therapeutic or prophylactic prop- 5 — See the judgment in Van Bennekom, cited above, para- erties of a particular product was disclosed graph 18. by a third party other than the seller or the 6 — See, to that effect, the judgment cited in the preceding foot- supplier, I would say forthwith that that cir- note, the judgment in Case C-369/88 Delatare [1991] ECR I- 1487, paragraphs 40 and 41, and the judgment in Case cumstance is not in itself conclusive for the C-60/89 Monteil and Samanni [1991] E C R 1-1547, para- graph 23. purposes of the categorization of the product

in question. What is conclusive, however, is 6. The national court also refers to Article whether or not the disclosure of such infor- 10 of the European Convention on Human mation was linked, even indirectly, with the Rights and asks essentially whether the pro- producer or supplier of the product in ques- hibition on publishing information such as tion. The possible existence of any link that at issue involves a violation of freedom whatsoever between the author of the publi- of expression as enshrined in that article of cation and/or the person responsible for its the Convention. distribution and the producer or supplier of the product in question will in fact constitute evidence of an intention to market it (or, rather, to make it appear) as a medicinal product, with the result that the product itself will have to be classed as a medicinal product by virtue of its presentation within the meaning of the first subparagraph of Article 1(2) of Directive 65/65. The Court has consistently held 7 that funda- mental rights form an integral part of the general principles of law, the observance of which it ensures. For that purpose the Court draws inspiration from the constitutional traditions common to the Member States and from international treaties on which the In the final analysis, whilst it is true that a Member States have collaborated or of which connection between the product and its pre- they are signatories. In particular, the Court sentation is essential in order for it to be has held that Article 10 of the European classed as a medicinal product, it is also true Convention is a general principle the obser- that such a link may also be merely indirect. vance of which is ensured by the Court. 8 Consequently, if the 'presentation' of the therapeutic or prophylactic properties of the product is 'arranged' — on the assumption put forward by the national court — by means of a publication sent by a third party, it will be necessary to ascertain whether the third party is linked in some way with the producer or supplier of the product in ques- tion. For that purpose, it is sufficient, for Having said that, I completely rule out the example, that purchasers of the product possibility that the prohibition on disclosing should have come to know of the existence information about the 'non-existent' (at least of the publication through the seller, whereas in the present state of scientific knowledge) it is certainly not conclusive that the founda- therapeutic or prophylactic properties of a tion which sent the publication is legally sep- product may constitute a violation of Article arate from the producer or the supplier of 10 of the European Convention, especially the product in question. In each case, it is for since Article 10(2) provides for the possibil- the national court, which alone has direct knowledge of the facts of the case, to estab- lish whether any link exists between the 7 — See, most recently, the judgment in Case C-260/89 Ellimnkt third party in question and the producer or Radiophonia TUeorassi AE [1991] ECR 1-2925, paragraph 41. 8 — See the judgment in Ellininki Radiophonia Ttleorassi AE, the supplier of the relevant product. cited above, paragraph 44.

ity of restrictions on freedom of expression which is generally regarded as a foodstuff on grounds of the protection of public and, in the present state of scientific knowl- health. edge, has no pharmacological properties whatsoever, falls within the Community def- inition of a medicinal product by virtue of its presentation within the meaning of the first subparagraph of Article 1(2) of Directive 65/65 where it is presented by the seller or a What is more, the Community legislation on third party linked to the seller as having medicinal products, as is clear from the therapeutic or prophylactic properties. It is answer given to the second question, has no therefore clear that, if those conditions are effect whatsoever on freedom of expression satisfied, the product in question must in any where information on a product is published event be subjected to the system of prior by a third party who has no link — not even authorization, which, moreover, is intended indirectly — with the supplier or the seller to ensure that a product which is solely in of the product in question. It is scarcely nec- the nature of a foodstuff is not marketed as a essary to emphasize that in the event, how- medicinal product. ever, that such a link were established — which would mean that the product in ques- tion would have to be subjected to the sys- tem of prior authorization — freedom of expression unquestionably could not serve to circumvent the rules on the marketing of medicinal products to the detriment of con- sumers. The question under consideration must therefore be interpreted as covering only such products as do not fall within the Com- munity definition of medicinal products by virtue of their presentation and therefore in this case only such products as are presented 7. In its fourth question, the national court as medicinal products by a third party who asks whether it is compatible with the first is completely independent, de jure and de subparagraph of Article 1(2) of Directive facto, of the producer or the supplier. 65/65 that some Member States regard as medicinal products, not only products pre- sented as such within the meaning of that provision, but also foodstuffs which, albeit not possessing any pharmacological proper- ties, are presented by the seller or a third party as having prophylactic or therapeutic properties. In this connection, I would merely point out that, as the Court has already held, 'subject to Article 30 et seq. of the Treaty concerning products imported from other Member States, Community law does not affect the It has already been stated in answering the right of Member States to subject such sub- first three questions that even a product stances to controls or to require prior autho-

(3) A product which does not fall within the Community definition of a medici- nal product by virtue of its presentation may be subjected by the Member States — subject to Article 30 et seq. of the Treaty as regards imported prod- ucts — to their own domestic legislation on medicinal products.

9 — Judgment in Case 35/85 Procureur de la République v Tissier [1986] ECR 1207, paragraph 22.

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