Deutscher Apothekerverband eV v 0800 DocMorris NV and Jacques Waterval.

• Jurisdiction: European Union
• Celex Number: 62001CC0322
• ECLI: ECLI:EU:C:2003:147
• Date: 11 March 2003
• Docket Number: C-322/01
• Court: Court of Justice (European Union)
• Procedure Type: Reference for a preliminary ruling

OPINION OF ADVOCATE GENERAL
STIX-HACKL
delivered on 11 March 2003 (1)


Case C-322/01

Deutscher Apothekerverband e.V.
v
1.0800 DocMorris NV
2. Jacques Waterval


(Reference for a preliminary ruling from the Landgericht (Regional Court) Frankfurt am Main (Germany))

((Interpretation of Articles 28 EC and 30 EC, Council Directive 92/28/EEC on the advertising of medicinal products for human use and Directive 2000/31/EC of the European Parliament and of the Council ( Directive on electronic commerce) – National legislation restricting the supply of medicinal products for human use by a pharmacy established in another Member State on the basis of individual orders placed by consumers on the internet – Prescription requirement – Prohibition on advertising the sale of medicinal products by mail order – Internet pharmacy))

I ─ Introduction 1. The present reference for a preliminary ruling concerns internet pharmacies and the question whether the Member States may restrict the supply of medicinal products by a pharmacy established in another Member State on the basis of individual orders placed by consumers on the internet. In particular, it concerns the interpretation of the principle of free movement of goods and a number of provisions of secondary law. II ─ Legal framework

A ─

Community law 1. Authorisation of medicinal products (a) Previous legal position: Directive 65/65/EEC as amended by Directive 93/39/EEC 2. The central provisions on the authorisation of medicinal products can be found in Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, (2) as amended by Council Directive 93/39/EEC of 14 June 1993 amending Directives 65/65/EEC, 75/318/EEC and 75/319/EEC in respect of medicinal products (3) (hereinafter: Directive 65/65). Article 3 of that directive provides: 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 Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EEC) No 2309/93 of 22 July 1993 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products.The provisions of this Directive shall not affect the powers of the Member States' authorities either as regards the setting of prices for medicinal products or their inclusion in the scope of national health insurance schemes, on the basis of health, economic and social conditions. (b) Present legal position: Directive 2001/83/EC 3. With effect from 18 December 2001, Directive 65/65 was replaced by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (4) (hereinafter: Community code). Article 6(1) of the Community code provides: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 Member State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EEC) No 2309/93. 2. Advertising of medicinal products (a) Previous legal position: Directive 92/28/EEC 4. The relevant legislation in this regard is Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use (5) (hereinafter: Directive 92/28). 5. Article 1(3) and (4) of that directive provides: For the purposes of this Directive, advertising of medicinal products shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular:

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the advertising of medicinal products to the general public,

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advertising of medicinal products to persons qualified to prescribe or supply them,

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visits by medical sales representatives to persons qualified to prescribe medicinal products,

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the supply of samples,

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the provision of inducements to prescribe or supply medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind, except when their intrinsic value is minimal,

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sponsorship of promotional meetings attended by persons qualified to prescribe or supply medicinal products,

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sponsorship of scientific congresses attended by persons qualified to prescribe or supply medicinal products and in particular payment of their travelling and accommodation expenses in connection therewith. (4) The following are not covered by this Directive:

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the labelling of medicinal products and the accompanying package leaflets, which are subject to the provisions of Directive 92/27/EEC;

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correspondence, possibly accompanied by material of a non-promotional nature, needed to answer a specific question about a particular medicinal product;

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factual, informative announcements and reference material relating, for example, to pack changes, adverse-reaction warnings as part of general drug precautions, trade catalogues and price lists, provided they include no product claims;

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statements relating to human health or diseases, provided there is no reference, even indirect, to medicinal products.

6. Article 2(1) states:Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorisation has not been granted in accordance with Community law. 7. Article 3 provides inter alia: 1. Member States shall prohibit the advertising to the general public of medicinal products which:

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are available on medical prescription only, in accordance with Directive 92/26/EEC,

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contain psychotropic or narcotic substances, within the meaning of the international conventions,

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may not be advertised to the general public in accordance with paragraph 2. 2. Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary. (b) Present legal position: Community code 8. With effect from 18 December 2001, Directive 92/28 was replaced by the Community code. 9. Article 86 of the Community code has essentially the same wording as Article 1(3) and (4) of Directive 92/28. 10. Article 87 of the Community code, which replaces Article 2 of Directive 92/28, provides: 1. Member States shall prohibit any advertising of a medicinal product in respect of which a marketing authorisation has not been granted in accordance with Community law.2. All parts of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics.3. The advertising of a medicinal product:

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shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties,

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shall not be misleading.

11. Article 88 contains a similar provision to Article 3 of Directive 92/28. 3. Distance sales 12. The provisions applicable to distance sales can be found in Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts (hereinafter: Directive 97/7). (6) 13. Article 14 of Directive 97/7 provides:Member States may introduce or maintain, in the area covered by this Directive, more stringent provisions compatible with the Treaty, to ensure a higher level of consumer protection. Such provisions shall, where appropriate, include a ban, in the general interest, on the marketing of certain goods or services, particularly medicinal products, within their territory by means of distance contracts, with due regard for the Treaty. 4. Electronic commerce 14. The relevant legislation for electronic commerce is Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ( Directive on electronic commerce, (7) hereinafter: E-commerce directive). 15. The 11th recital of the E-commerce directive provides:This Directive is without prejudice to the level of protection for, in particular, public health and consumer interests, as established by Community acts. ... that same Community acquis, which is fully applicable to information society services, also embraces in particular Council Directive ... and Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products. 16. Article 1 of that directive includes the following provisions: 1. This Directive seeks to contribute to the proper functioning of the internal market by ensuring the free movement of information society services between the Member States.2. This Directive approximates, to the extent necessary for the achievement of the objective set out in paragraph 1, certain national provisions on information society services relating to the internal market, the establishment of service providers, commercial communications, electronic contracts, the liability of intermediaries, codes of conduct, out-of-court dispute settlements, court actions and cooperation between Member States.3. This Directive complements Community law applicable to information society services without...