Deutscher Apothekerverband eV v 0800 DocMorris NV and Jacques Waterval.

• Jurisdiction: European Union
• Celex Number: 62001CJ0322
• ECLI: ECLI:EU:C:2003:664
• Docket Number: C-322/01
• Court: Court of Justice (European Union)
• Procedure Type: Reference for a preliminary ruling
• Date: 11 December 2003

Case C-322/01


Deutscher Apothekerverband eV
v
0800 DocMorris NV and Jacques Waterval


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

«(Articles 28 EC and 30 EC – Directives 92/28/EEC and 2000/31/EC – National legislation restricting internet sales of medicinal products for human use by pharmacies established in another Member State – Doctor's prescription required for supply – Prohibition on advertising the sale of medicinal products by mail order)»

Opinion of Advocate General Stix-Hackl delivered on 11 March 2003

I - 0000

Judgment of the Court, 11 December 2003

I - 0000

Summary of the Judgment

1..

Free movement of goods – Quantitative restrictions – Measures having equivalent effect – Definition – Prohibition on the sale by mail order of medicinal products the sale of which is restricted to pharmacies – Whether included – Justification limited to medicinal products subject to prescription – Reimportation of medicinal products into the Member State concerned – Not relevant

( Arts 28 EC and 30 EC )

2..

Approximation of laws – Proprietary medicinal products – Advertising – Prohibition on advertising the sale by mail order of medicinal products the sale of which is restricted to pharmacies – Permissible only in respect of medicinal products subject to prescription

( Directive 2001/83/EC of the European Parliament and of the Council, Art. 88 )

1.

Commercial rules which govern the arrangements for the sale of products constitute measures of equivalent effect for the purposes of Article 28 EC if they do not apply to all relevant traders operating in national territory and if they do not affect in the same manner, in law and in fact, the marketing of both domestic products and those from other Member States. A national prohibition on the sale by mail order of medicinal products the sale of which is restricted to pharmacies in the Member State concerned is in that regard a measure having an effect equivalent to a quantitative restriction where the prohibition has a greater impact on pharmacies established outside the national territory and could impede access to the market for products from other Member States more than it impedes access for domestic products. Article 30 EC may, however, be relied on to justify such a national prohibition on the sale by mail order of medicinal products in so far as the prohibition covers medicinal products subject to prescription. Given that there may be risks attaching to the use of these medicinal products, the need to be able to check effectively and responsibly the authenticity of doctors' prescriptions and to ensure that the medicine is handed over either to the customer himself, or to a person to whom its collection has been entrusted by the customer, is such as to justify a prohibition on mail-order sales. However, Article 30 EC cannot be relied on to justify an absolute prohibition on the sale by mail order of medicinal products which are not subject to prescription in the Member State concerned. Those findings do not need to be assessed differently where medicinal products are imported into a Member State in which they are authorised, having been previously obtained by a pharmacy in another Member State from a wholesaler in the importing Member State. see paras 68, 74, 76, 112, 119, 124, 134, operative part 1

2.

Article 88(1) of Directive 2001/83 on the Community code relating to medicinal products for human use, which prohibits advertising for prescription medicines, precludes a national prohibition on advertising the sale by mail order of medicinal products which may be supplied only in pharmacies in the Member State concerned in so far as the prohibition covers medicinal products which are not subject to prescription. Article 88(2) of the Community Code, which allows medicinal products not subject to prescription to be advertised to the general public, cannot be interpreted as precluding advertising for the sale by mail order of medicines on the basis of the alleged need for a pharmacist to be physically present, since the prohibition on the sale by mail order cannot itself be justified, in relation to non-prescription medicines, by that alleged need. see paras 143-144, 148, operative part 2

JUDGMENT OF THE COURT
11 December 2003 (1)

((Articles 28 EC and 30 EC – Directives 92/28/EEC and 2000/31/EC – National legislation restricting internet sales of medicinal products for human use by pharmacies established in another Member State – Doctor's prescription required for supply – Prohibition on advertising the sale of medicinal products by mail order))

In Case C-322/01, REFERENCE to the Court under Article 234 EC by the Landgericht Frankfurt am Main (Germany) for a preliminary ruling in the proceedings pending before that court between Deutscher Apothekerverband eV

and

0800 DocMorris NV, Jacques Waterval, on the interpretation of Articles 28 EC and 30 EC and of Article 1(3) and (4) and Articles 2 and 3 of Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use (OJ 1992 L 113, p. 13), in conjunction with 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 ( the Directive on electronic commerce) (OJ 2000 L 178, p. 1),

THE COURT,,

composed of: V. Skouris, President, P. Jann, C.W.A. Timmermans, C. Gulmann, J.N. Cunha Rodrigues and A. Rosas (Presidents of Chambers), D.A.O. Edward (Rapporteur), A. La Pergola, J.-P. Puissochet, R. Schintgen, F. Macken, N. Colneric and S. von Bahr, Judges, Advocate General: C. Stix-Hackl,
Registrar: H.A. Rühl (Principal Administrator),

after considering the written observations submitted on behalf of:

─

Deutscher Apothekerverband eV, by C. Dechamps, Rechtsanwalt, assisted by J. Schwarze,

─

0800 DocMorris NV and J. Waterval, by Professor C. Koenig,

─

the German Government, by W.-D. Plessing and B. Muttelsee-Schön, acting as Agents,

─

the Greek Government, by F. Georgakopoulos, D. Kalogiros and E.-M. Mamouna, acting as Agents,

─

the French Government, by G. de Bergues and R. Loosli-Surrans, acting as Agents,

─

the Irish Government, by D.J. O'Hagan, acting as Agent, and N. Hyland, Barrister,

─

the Austrian Government, by C. Pesendorfer, acting as Agent,

─

the Commission of the European Communities, by J.-C. Schieferer, acting as Agent, assisted by M. Núñez Müller, Rechtsanwalt,

having regard to the Report for the Hearing,

after hearing the oral observations of Deutscher Apothekerverband eV, represented by C. Dechamps, assisted by J. Schwarze, 0800 DocMorris NV and J. Waterval, represented by C. Koenig, the German Government, represented by W.-D. Plessing, the Greek Government, represented by D. Kalogiros and M. Apessos, acting as Agent, the French Government, represented by R. Loosli-Surrans, and the Commission, represented by J.-C. Schieferer, at the hearing on 10 December 2002,

after hearing the Opinion of the Advocate General at the sitting on 11 March 2003,

gives the following

Judgment

1

By order of 10 August 2001, received at the Court Registry on 21 August 2001, the Landgericht Frankfurt am Main (Regional Court, Frankfurt am Main) referred to the Court for a preliminary ruling pursuant to Article 234 EC three questions concerning the interpretation of Articles 28 EC and 30 EC and of Article 1(3) and (4) and Articles 2 and 3 of Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use (OJ 1992 L 113, p. 13), in conjunction with 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 ( the Directive on electronic commerce) (OJ 2000 L 178, p. 1).

2

Those questions arose in proceedings between (i) Deutscher Apothekerverband eV ( the Apothekerverband) and (ii) 0800 DocMorris NV ( DocMorris) and Mr Waterval concerning internet sales of medicinal products for human use in a Member State other than that in which DocMorris and Mr Waterval are established.

Legal background

Community legislation Directives regulating the sale of medicinal products

3

Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ, English Special Edition 1965-1966, p. 20), as amended by Council Directive 93/39/EEC of 14 June 1993 (OJ 1993 L 214, p. 22), ( Directive 65/65), makes the placing on the market of medicinal products subject to prior authorisation. Article 3 of the directive provided: 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 Council 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 [OJ 1993 L 214, p. 1].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.

4

With effect from 18 December 2001, Directive 65/65 was repealed...