Opinion of Advocate General Gulmann delivered on 16 June 1994

1 Original language: Danish.

2 The provision is worded as follows: Medicinal products for which authorization or registration is required may be introduced into the territory to which this Law applies, with the exception of customs-free areas other than the Island of 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 paragraphs 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.

3 The provision reads as follows: Notwithstanding the provisions of the subparagraph 1, ready-prepared medicinal products which are not authorized or registered for markeung in the territory to which this Law applies or are not exempt from authorization or registration may be introduced into the territory to which this Law applies if the marketing thereof is lawful in the country of origin and if they are ordered by pharmacists. Pharmacists may procure such medicinal products only in small quantities on a medical, dental or veterinary prescription and to the special order of individual persons and may supply them only in the course of the normal business of a pharmacist ...

4 The provision is worded as follows: Advertisements containing an offer to obtain given medicinal products by individual importation under paragraph 73(2)(6a) or paragraph 73(3) shall be prohibited.

5 [1993] ECR I-6097.

6 [1993] ECR I-6787 at paragraph 22.

7 Later, in relation to my view with regard to the second question from the court of reference, I shall go further into the purpose of the contested German provision.

8 As Eurim-Pharm, the Commission and the French Government have stated, the Court has declared that national legislation which restricts or prohibits certain forms of advertising and certain means of sales promotion may ... be such as to restrict the volume of trade because it affects marketing opportunities for imported products and that such legislation 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 quantitative restrictions according to the extent of their effect on trade within the Community. See the judgment in Case C-126/91 Yves Rocher [1993] I-2361 at paragraphs 10 and 21. See also inter alia the judgments in Case 286/81 Oosthoek's Uitgeversmaatschappij [1982] ECR 4575 at paragraph 15, in Case 382/87 Buet [1989] ECR 1235 at paragraph 7, in Case C-362/88 GBINNOBM [1990] ECR I-667 at paragraph 7, in Case C-241/89 SARPP [1990] ECR 4695 at paragraph 29, in Case C-369/88 Delatare [1991] ECR I-1487 at paragraph 50 and in Joined Cases C-l/90 and C-176/90 Aragonesa de Publicidad Extenor and Puhlivia [1991] ECR I-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 conditions set out in the Keck and Mithouard judgment are not met.

9 The Council has approved a long series of measures intended to achieve a harmonization in the medicinal products sector. See in particular Council Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (OJ 1993 L 214, p. 1) which, with effect from 1 January 1995, introduces a centralized Community authorization procedure for technologically advanced medicinal products and Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/31S/EEC and 75/319/EEC in respect of medicinal products (OJ 1993 L 214, p. 22) laying down for other medicinal products rules regarding a decentralized Community authorization procedure, according to which the marketing of a medicinal product in a Member State continues to be subject to the competent authorities of that Member State having granted authorization therefor, but under which authorization to place a medicinal product on the market in one Member State is in principle to be recognized by the authorities of the other Member States unless there are serious grounds for supposing that authorization may present a risk to public health and in which a disagreement between the Member States about the Quality, the safety or the efficacy of a medicinalproduct is to be settled by a decision having binding effect throughout the Community by means of a scientific evaluation by the European Agency for the Evaluation of Medicinal Products. The directive is to be transposed by the Member States before 1 January 1995.

10 See in particular the judgments in Case 215/87 Schumacher [1989] ECR 617 at paragraph 15, in Case C-369/88 Dekttre [1991] ECR I-1487 at paragraph 48, in Case C-347/89 Eurim-Pharm [1991] ECR I-1747 at paragraph 26, in Case C-62/90 Commission v Germany [1992] ECR I-2575 at paragraph 10 and, most recendy, in Case C-317/92 Commission v Germany [1994] ECR I-2039 at paragraph 14.

11 OJ 1992 L 113, p. 13.

12 See for example the judgments in Case 62/90 Commission v Germany at paragraphs 10 and 11, in the Schumacher case at paragraphs 17 and 18, in the Delattre case at paragraph 53 and in the Eurim-Pharm case at paragraphs 26 and 27, all already cited in footnote 9.

13 OJ, English Special Edition 1965-1966, p. 20.

14 OJ 1989 L 142, p. 11.

15 See in this respect also the first recital in the preamble to the directive, which sutes: ... the primary purpose of any rules concerning the production and distribution of proprietary medicinai products must be to safeguard public health.

16 Bundestagsdrucksache No 11/5373 regarding Article 6 of the draft Law.

17 The Commission adds that the opportunity to import unauthorized medicinal products on an individual order was intended to apply to cases in which a foreigner is in Germany and continues to need medicine which is authorized in his own country and that that type of importation does not apply to new medicinal products. The French Government adds that advertisements for unauthorized medicinal products cause the public to exert pressure on the authorities for authorization to be given, which distorts the authorization procedure.

18 It was stated during the proceedings that Eurim-Pharm's advertisement had mdeed the sole purpose of informing interested circles where they might obtain the medicinal products in question. As an example of the advertising at issue it is stated in the order for reference that on 6 August 1992 the company had an advertisement in the Pharmazeutische Zeitung, a specialist journal purchased and read exclusively by the specialist circles concerned, worded as follows: Individual imports in accordance with 73(3) AMG obtained at short notice and at low prices, inter alia, Dysport, Imigran, Jumex, Paludrine, Regaine, Eurim-Pharm GmbH 8235 Piding, Am Gänselehen 4-5.

19 Judgment in Case 152/78 Commission v France [1980] ECR 2299 at paragraph 17.

20 [1989] ECR 617.

21 [1992] ECR I-2575.

22 As stated by the Commission, the provision must be interpreted in its context, in particular in the light of the principle of national authorization of medicinal products as laid down in Article 3 of Directive 65/65. In addition it seems to me convincing when the Commission contends that the slightly equivocal reference to marketing authorization ... in accordance with Community law results from the fact that the provision was drafted with a view to the future Community system in the medicinal products sector, according to which authorization of medicinal products may take place under a centralized Community procedure or a decentralized one by which it continues to be in principle the Member States which grant marketing authorization within their respective territories; see footnote 8 above.

23 The French Government and Ortscheit have finally referred to Article 2(4) of Directive 65/65 as amended by Directive 89/341, which gives Member States the opportunity to derogate from the requirement for national authorization in Article 3. The paragraph reads as follows: A Member Sute 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 order, formulated in accordance with the specifications of an authorized health care professional and for use by his individual patients on his direct personal responsibility. The French Government claims that permission to advertise for unauthorized medicinal products would be incompatible with the restrictions laid down in that provision, in particular in so far as concerns unsolicited orders. However, I think it is doubtful whether Article 2(4) covers derogations of the kind with which we are concerned, where it is not a question of medicinal products prepared according to instructions from a recognized practising doctor for his own patients. But the provision snows at any rate that the marketing of unauthorized medicinal products must be an exception.