Ludwigs - Apotheke München Internationale Apotheke v Juers Pharma Import-Export GmbH.
Date: 2007-11-08
19. As is clear from the account of the German legislation applicable in the main proceedings which appears in the order for reference, Paragraph 73(1) of the AMG prohibits the marketing in Germany of medicinal products which require approval or registration unless they have been approved or registered. As the Court found in Case C‑322/01 Deutscher Apothekerverband  [2003] ECR I‑14887, paragraph 52, that general prohibition corresponds to the prohibition, at Community level, on placing on the market medicinal products which have not been authorised in the Member State concerned, provided for by the first subparagraph of Article 6(1) of Directive 2001/83. According to that provision, no medicinal product may be placed on the market of a Member State unless a marketing authorisation has been issued by the competent authorities of that State in accordance with that directive or an authorisation has been granted in accordance with Regulation No 2309/93. Consequently, the Member States must, generally, entirely prohibit the marketing of medicinal products which are not covered by a national or Community marketing authorisation.
25. The free movement of goods is a fundamental principle of the Treaty which is expressed in the prohibition, set out in Article 28 EC, on quantitative restrictions on imports between Member States and all measures having equivalent effect.
26. That prohibition of measures having an effect equivalent to quantitative restrictions applies to all legislation of the Member States that is capable of hindering, directly or indirectly, actually or potentially, intra-Community trade (see, in particular, Case 8/74 Dassonville  [1974] ECR 837, paragraph 5, and Case C‑147/04 De Groot en Slot Allium and Bejo Zaden  [2006] ECR I‑245, paragraph 71).
27. Nevertheless, national rules which hinder the free movement of goods can be justified, as Article 30 EC provides, inter alia on grounds of protection of the health and life of humans. According to settled case‑law, the health and life of humans rank foremost among the assets or interests protected by Article 30 EC and, in the absence of Community harmonisation in the area concerned, it is for the Member States, within the limits imposed by the Treaty, to decide what degree of protection they wish to assure, always taking into account the requirements of the free movement of goods within the European Community (see, to that effect, Deutscher Apothekerverband , paragraph 103 and the case-law cited, and Joined Cases C‑158/04 and C‑159/04 Alfa Vita Vassilopoulos and Carrefour‑Marinopoulos  [2006] ECR I‑8135, paragraph 21).
28. However, in order for such national rules to comply with the principle of proportionality, it must be ascertained not only whether the means which they employ are suitable for the purpose of attaining the desired objectives but also whether those means do not go beyond what is necessary for that purpose (see, inter alia, Alfa Vita Vassilopoulos and Carrefour‑Marinopoulos , paragraph 22).
31. Nevertheless, the Court considered that that prohibition was justified under Article 36 of the EEC Treaty (subsequently Article 36 of the EC Treaty, and now, after amendment, Article 30 EC) for reasons connected with the protection of the health and life of humans. It stated at paragraphs 19 and 20 of its judgment in Ortscheit  that the prohibition has the purpose of ensuring that the individual importation of medicinal products which have not been authorised remains an exception, in order to prevent the general requirement of national authorisation under German law from being systematically circumvented, since, if medicinal products which were not authorised in Germany could be advertised there, there would be a danger that manufacturers would obtain authorisation for their medicinal products in a Member State imposing fewer requirements and then import them into Germany on the basis of individual orders which they would have encouraged by advertising campaigns. The Court found that the prohibition of advertising imposed by Paragraph 8 of the HWG is therefore necessary for the effectiveness of the national authorisation scheme.
33. Directive 2001/83 is based on the premiss that the marketing of a product which is classified as a medicinal product is conditional on the grant of a marketing authorisation, issued either by the competent authority of a Member State, or in the context of the centralised Community procedure under Regulation No 2309/93. That general rule, which is laid down in the first subparagraph of Article 6(1) of Directive 2001/83, allows derogations on the conditions set out in Article 5(1) of that directive. As already found at paragraphs 19 to 22 of the present judgment, it is apparent that the German legislation at issue in the main proceedings actually implements those provisions. Thus, following the example of Directive 2001/83, that national legislation aims to ensure that the possibility of importing non-approved medicinal products remains exceptional. The advertising of such medicinal products would have quite the opposite effect.
35. The Court finds that the specific function assigned to a prohibition on advertising such as that laid down in Paragraph 8 of the HWG consists in strengthening the exceptional nature of a derogating authorisation to market medicinal products which are not approved and not registered, such as that under Paragraph 73(3) of the AMG, thereby preserving the practical effect of the marketing authorisation procedure. Therefore, a restriction which follows from that prohibition may be considered to be justified by the protection of the health and life of humans, and necessary for that purpose, in accordance with Article 30 EC, inasmuch as it aims to limit the volume of imports of non-approved medicinal products.