C-320/93

1 — The provision is worded as follows: 'Medicinal products for which authorization or registration is required may be intro- duced into the territory to which this Law applies, with the exception of customs-free areas other than the Island of The facts Heligoland, only if they have been authorized or registered for marketing within the territory to which this Law applies, or exempted from such authorization or registration ...' It should be read in conjunction with paragraph 21(1) of the Law, which provides: 'Ready-prepared medicinal products which are medicinal products within the meaning of para- graphs 2(1) or 2(2)(1) may be marketed within the territory to which this Law applies only if they have been authorized by the competent Federal authorities'. 2 — The provision reads as follows: 'Notwithstanding the provi- 2. Paragraph 73(1) of the German Law on sions of the subparagraph 1, ready-prepared medicinal prod- ucts which are not authorized or registered for markeung in medicinal products (the Arzneimittelgesetz, the territory to which this Law applies or are not exempt from authorization or registration may be introduced into hereinafter referred to as 'the AMG') pro- the territory to which this Law applies if the marketing vides that medicinal products for which thereof is lawful in the country of origin and if they are ordered by pharmacists. Pharmacists may procure such authorization or registration is required may medicinal products only in small quantities on a medical, dental or veterinary prescription and to the special order of be imported into Germany only if they are individual persons and may supply them only in the course of the normal business of a pharmacist ...' 3 — The provision is worded as follows: 'Advertisements con- taining an offer to obtain given medicinal products by indi- vidual importation under paragraph 73(2)(6a) or paragraph * Original language: Danish. 73(3) shall be prohibited".

The first question concerning the interpre- tation of Article 30 of the Treaty 4. The Landgericht takes the view that Eurim-Pharm's advertisements are contrary to paragraph 8(2) of the H W G in so far as that provision is compatible with Articles 30 and 36 of the Treaty and on that basis has referred the following questions to the Court: 5. Eurim-Pharm, the Commission and the French Government contend that a ban on advertising such as that laid down in para- graph 8(2) of the H W G is a measure having an effect equivalent to a quantitative restric- '(1) Is the national prohibition of advertis- tion on imports within the meaning of Arti- ing for medicinal products which cle 30. Ortscheit and the Greek Government despite the requirement of authorization on the other hand do not think that such a are not authorized in Germany, but may national provision is covered by the prohibi- lawfully be imported from another tion in Article 30. The Belgian Government Member State of the European Com- merely states that the provision is compatible munity in response to an individual with Community law without specifying order if they have already been lawfully whether that is due to the fact that the pro- put into circulation in that Member vision is covered by Article 30 or that it is State, a measure having an effect equiv- justified under Article 36.

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ORTSCHEIT

It is obvious that the unequal treatment of domestic products and products from other Member States arises where stricter rules are applied to domestic goods. Thus domestic products may in all circumstances be mar- keted only if they have received authoriza- tion. O n those grounds it may be claimed that a provision such as paragraph 8(2) of the 7. A ban on advertisements such as that in H W G cannot, for products from another paragraph 8(2) of the H W G must be Member State, 'prevent their access to the regarded as a provision prohibiting certain market or ... impede access any more than it selling arrangements within the meaning of impedes the access of domestic products' (cf. the judgment in Keck and Mithouard. That is paragraph 17 of the Keck and Mithouard confirmed by the Court's judgment in Case judgment). C-292/92 Hiinermund, in which the Court decided that that condition was met as far as concerned a rule of professional ethics adopted by a professional organization in a Member State according to which pharma- cists within the sphere of responsibility of the organization were prohibited from advertising outside their pharmacies prod- ucts normally dealt with by pharmacists and for which authorization was required. 5

But in my view the decisive point must be 4 — [1993] ECR 1-6097. that — irrespective of the rules applicable to 5 — [1993] ECR 1-6787 at paragraph 22. domestic products — it is a provision

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O P I N I O N OF MR G U L M A N N — CASE C-320/93

That view cannot be accepted since the rele- 10. The Greek Government and Ortscheit vant advertisements are aimed at doctors and contend that the German provision at issue prohibits only advertisements for medicinal products which may be imported on an indi- 7 — As Eurim-Pharm, the Commission and the French Govern- vidual order so that it cannot therefore pre- ment have stated, the Court has declared that 'national leg- islation which restricts or prohibits certain forms of advertis- vent the importation of the medicinal prod- ing and certain means of sales promotion may ... be such as to restrict the volume of trade because it affects marketing ucts in question. opportunities' for imported products and that such legisla- tion therefore represents a measure having equivalent effect to quantitative restrictions on imports within the meaning of Arnele 30 of the EEC Treaty. It is clear further that Article 30 does not distinguish between measures which are to be described as measures having an effect equivalent to quanti- tative restrictions according to the extent of their effect on trade within the Community. See the judgment in Case C-126/91 Yves Rocher [1993] 1-2361 at paragraphs 10 and 21. See also inter alia the judgments in Case 286/81 Oosthoek'* Uitgeversmaatschappij [1982] ECR 4575 at paragraph 15, in Case 382/87 Buet [1989] ECR 1235 at paragraph 7, in Case That argument cannot be upheld. There can C-362/88 GB-INNO-BM [1990] ECR 1-667 at paragraph 7, in Case C-241/89 SARPP [1990] ECR 4695 at paragraph 29, be no doubt that a ban on advertising such as in Case C-369/88 Delatare [1991] ECR 1-1487 at paragraph 50 and in Joined Cases C-l/90 and C-176/90 Aragonesa de Publicidad Extenor and Puhlivia [1991] ECR 1-4151 at paragraph 10). That case-law is in my view still decisive for an appraisal of provisions prohibiting certain forms of sale when it may be determined, as in this case, that moreover the 6 — Later, in relation to my view with regard to the second ques- conditions set out in the Keck and Mithouard judgment are tion from the court of reference, I shall go further into the not met. purpose of the contested German provision.

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OPINION OF MR GULMANN — CASE C-320/93

tion of health and life of humans, 8 and it is among the property or interests protected by therefore still permissible to rely on Article Article 36 of the Treaty and it is for the 36 to justify national measures restricting Member States, within the limits imposed by trade in this sector. 9 In this connection the the Treaty, to decide what degree of protec- Commission and the French Government tion they intend to ensure'. However, the have stressed in particular that Council Court points out at the same time that 'it Directive 92/28/EEC of 31 March 1992 o n follows from Article 36 that national rules or the advertising of medicinal products for practices having, or likely to have, a restric- human use 10 was not due to be transposed tive effect on the importation of pharmaceu- by the Member States until 1 January tical products are compatible with the Treaty 1993 and could not therefore rattorte tempo- only to the extent to which they are neces- ris apply in this case, in which the advertising sary for the effective protection of health and at issue occurred from April 1992 onwards life of humans. National rules or practices and the action was brought before the cannot benefit from the derogation provided Landgericht Saarbrücken on 14 October for in Article 36 if the health and life of 1992. humans may be protected just as effectively by measures which are less restrictive of intra-Community trade'. n

15. The Court has consistently held that 'the health and life of humans rank foremost

9 — See in particular the judgments in Case 215/87 Schumacher [1989] ECR 617 at paragraph 15, in Case C-369/88 Dekttre [1991] ECR 1-1487 at paragraph 48, in Case C-347/89 Eurim-Pharm [1991] E C R 1-1747 at paragraph 11 — See for example the judgments in Case 62/90 Commission v 26, in Case C-62/90 Commission v Germany [1992] ECR Germany at paragraphs 10 and 11, in the Schumacher case 1-2575 at paragraph 10 and, most recendy, in Case at paragraphs 17 and 18, in the Delattre case at paragraph C-317/92 Commission v Germany [1994] ECR 1-2039 at 53 and in the Eurim-Pharm case at paragraphs 26 and 27, all paragraph 14. already cited in footnote 9. 10 — O J 1992 L 113, p. 13. 12 — OJ, English Special Edition 1965-1966, p. 20.

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Directive 89/341/EEC of 3 May 1989, >3 19. Ortscheit, the Commission and the Article 3 of which provides: French Government contend that a provi- sion such as that in paragraph 8(2) of the H W G must be regarded as justified and nec- essary for the protection of the Ufe and health of humans in accordance with Article 36 simply because it may be stated that its purpose is to restrict a derogation from a principal rule which is regarded under Com- ' N o proprietary medicinal product may be munity law as necessary for the protection of placed on the market in a Member State Ufe and health of humans. As far as can be unless an authorization has been issued by seen the Belgian Government essentially the competent authority of that Member shares that view. State'. ' 4

17. It is therefore also common ground in the case that paragraph 73(3) of the AMG is a derogation permitting an import which, The fact that the ban on advertising in para- under Community law, Germany is under graph 8(2) of the H W G has that purpose is no obligation to permit and that the prohibi- confirmed by the explanatory memorandum tion of advertising the relevant medicinal to the draft of the provision, which states: products, in paragraph 8(2) of the H W G , aims to limit the extent of such imports.

O n these grounds it is claimed that a ban o n 21. Eurim-Pharm claims that an advertising advertising is necessary to avoid doctors and ban such as is at issue here is not necessary pharmacists being encouraged to prescribe or appropriate for the protection of the life and order unauthorized medicinal products and health of humans, since it is the use of which may be imported on individual order the medicinal product and not the advertis- under paragraph 73(3) of the AMG. A sys- ing as such which may represent a danger to tematic application of that derogation would human life and health. What is decisive, mean the derogation becoming a principal according to Eurim-Pharm, is that it is a rule, which would undermine the system of question of advertising for medicinal prod- authorization for marketing of medicinal ucts which the German legislature authorizes products. Ortscheit states that the producers for marketing in pursuance of paragraph of medicinal products would then have the 73(3) of the AMG and so does not regard as opportunity to circumvent the requirement harmful to health. The company further for national authorization, since they could emphasizes that these are medicinal products obtain authorization in the Member State which are authorized in other Member States which imposes the fewest requirements and and therefore cannot be regarded, either, as subsequently, by means of advertising cam- dangerous for the health of German consum- paigns and the rules on importation on indi- ers. According to Eurim-Pharm concern for vidual order, market the medicinal products the protection of the Ufe and health of in question in Germany. I 6 humans is already sufficiently safeguarded by the conditions laid down in paragraph 73(3) of the AMG for the import of unauthorized medicinal products and by the requirements imposed on pharmacists by the Verordnung über den Betrieb von Apotheken (regulation o n pharmacists) with a view to making it possible for the competent authorities to control imports of medicinal products. Finally the company adds that the possibility of advertising on the other hand is necessary to ensure that doctors and pharmacists are appropriately informed as to the possibility of obtaining medicinal products which are 20. Eurim-Pharm and, as far as can be seen, available in other Member States. 17 the Greek Government think that there should be an independent inquiry as to whether the advertising ban in paragraph 8(2) of the H W G , regarded in isolation, is necessary for the protection of the life and health of humans.

22. The Greek Government contends on the In the same way it may be hard to see that, contrary that the ban on advertising is natu- regarded in isolation, a ban on the advertis- rally necessary to protect the life and health ing of unauthorized medicinal products of humans, since advertising risks encourag- which may be marketed in one Member ing doctors and pharmacists to promote the State should be necessary for the protection sale of medicinal products which the compe- of the life and health of humans. tent national authorities either regard as dan- gerous to health and have refused to autho- rize or have not had the opportunity to check, and the effects of which are therefore unknown. The Greek Government points out that it follows from the Court's case-law It would however be wrong to appraise in that 'advertising acts as an encouragement to isolation a provision such as that at issue consumption' and rules which prohibit or here. restrict advertising 'are not therefore a mat- ter of indifference from the point of view of the requirements of public health recognized by Article 36 of the Treaty'. 1 8

If the basic rule prohibiting the marketing of unauthorized medicinal products is in gen- eral regarded as necessary to protect the life and health of humans, a provision which aims at restricting as far as possible deroga- 23. The first of the two basic views tions from that rule must in the same way be expressed is, in my opinion, correct. regarded in general as necessary to protect that interest.

24. Contrary to what Eurim-Pharm claims, the judgments in Case 215/87 Schumacher I9 and in Case C-62/90 Commission v Germa- 'Member States shall prohibit any advertising ny 20 cannot be quoted as support for the of a medicinal product in respect of which company's claim that the ban on advertising a marketing authorization has not been is incompatible with Articles 30 and 36. granted in accordance with Community law'. Those judgments concerned provisions of paragraph 73 of the AMG involving essen- tially the fact that the legality of the impor- tation of medicinal products from other Member States was conditional upon not only a national authorization but also on the fact that the consignee must either be a phar- maceutical undertaking, a wholesaler or a 26. Eurim-Pharm contends that the provi- veterinary surgeon or must run a pharmacy. sion should be interpreted as meaning that The Court decided that the provisions in the Member States are only to prohibit the question were incompatible with Articles advertising of medicinal products which are 30 and 36 of the Treaty in so far as they pro- not authorized in any Member State, since hibited individuals from importing for their that interpretation harmonizes best with the own use medicinal products purchased in future legal position in which authorization other Member States which in the State of of medicinal products is to be a Community importation were available without or with a matter. The company thinks therefore that medical prescription respectively. Those the provision may be regarded as supporting cases did not therefore raise the question of its viewpoint, according to which it must be the importation of unauthorized medicinal permissible in a Member State to advertise products but only of who could effect the medicinal products which are authorized in importation of medicinal products which another Member State. had received authorization in the State of importation. As the Commission and the French Government state, those cases are therefore essentially different from this case and have no decisive significance for it.

22 — The French Government and Ortscheit have finally referred 29. O n the present basis and for the pur- to Article 2(4) of Directive 65/65 as amended by Directive poses of an opinion on this case I therefore 89/341, which gives Member States the opportunity to der- ogate from the requirement for national authorization in Article 3. The paragraph reads as follows: 'A Member S u t e may, in accordance with legislation in force and to fulfil special needs, exclude from Chapters II to V medicinal products supplied in response to a bona ßde unsolicited 21 — As stated by the Commission, the provision must be inter- order, formulated in accordance with the specifications of preted in its context, in particular in the light of the princi- an authorized health care professional and for use by his ple of national authorization of medicinal products as laid individual patients on his direct personal responsibility.' down in Article 3 of Directive 65/65. In addition it seems to The French Government claims that permission to advertise me convincing when the Commission contends that the for unauthorized medicinal products would be incompati- slightly equivocal reference to 'marketing authorization ... ble with the restrictions laid down in that provision, in par- in accordance with Community law' results from the fact ticular in so far as concerns unsolicited orders. However, I that the provision was drafted with a view to the future think it is doubtful whether Article 2(4) covers derogations Community system in the medicinal products sector, of the kind with which we are concerned, where it is not a according to which authorization of medicinal products question of medicinal products prepared according t o may take place under a centralized Community procedure instructions from a recognized practising doctor for his or a decentralized one by which it continues to be in prin- own patients. But the provision snows at any rate that the ciple the Member States which grant marketing authoriza- marketing of unauthorized medicinal products must be an tion within their respective territories; see footnote 8 above. exception.

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