Criminal proceedings against Frede Damgaard.

• Jurisdiction: European Union
• Celex Number: 62007CJ0421
• ECLI: ECLI:EU:C:2009:222
• Date: 02 April 2009
• Court: Court of Justice (European Union)
• Procedure Type: Reference for a preliminary ruling
• Docket Number: C-421/07

Case C-421/07

Criminal proceedings

against

Frede Damgaard

(Reference for a preliminary ruling from the Vestre Landsret)

(Medicinal products for human use – Directive 2001/83/EC – Concept of ‘advertising’ – Dissemination of information about a medicinal product by a third party acting on his own initiative)

Summary of the Judgment

Approximation of laws – Medicinal products for human use – Directive 2001/83 – Advertising

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 86)

Article 86 of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, is to be interpreted as meaning that dissemination by a third party of information about a medicinal product, including its therapeutic or prophylactic properties, may be regarded as advertising within the meaning of that article, even though the third party in question is acting on his own initiative and completely independently, de jure and de facto, of the manufacturer and the seller of such a medicinal product. It is for the national court to determine whether that dissemination constitutes a form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products.

(see para. 29, operative part)

JUDGMENT OF THE COURT (Second Chamber)

2 April 2009 (*)

(Medicinal products for human use – Directive 2001/83/EC – Concept of ‘advertising’ – Dissemination of information about a medicinal product by a third party acting on his own initiative)

In Case C‑421/07,

REFERENCE for a preliminary ruling under Article 234 EC from the Vestre Landsret (Denmark), made by decision of 6 August 2007, received at the Court on 13 September 2007, in the criminal proceedings against

Frede Damgaard,

THE COURT (Second Chamber),

composed of C.W.A. Timmermans, President of the Chamber, J.‑C. Bonichot, K. Schiemann (Rapporteur), J. Makarczyk and C. Toader, Judges,

Advocate General: D. Ruiz-Jarabo Colomer,

Registrar: C. Strömholm, Administrator,

having regard to the written procedure and further to the hearing on 9 October 2008,

after considering the observations submitted on behalf of:

– Mr Damgaard, by S. Stærk Ekstrand, advokat,

– the Danish Government, by B. Weis Fogh, acting as Agent,

– the Belgian Government, by J.‑C. Halleux, acting as Agent,

– the Czech Government, by M. Smolek, acting as Agent,

– the Greek Government, by N. Dafniou, S. Alexandriou and K. Georgiadis, acting as Agents,

– the Polish Government, by T. Krawczyk, P. Dąbrowski and M. Dowgielewicz, acting as Agents,

– the United Kingdom Government, by Z. Bryanston-Cross, acting as Agent, and J. Stratford and J. Coppel, Barristers,

– the Commission of the European Communities, by H. Støvlbæk and M. Šimerdová, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 18 November 2008,

gives the following

Judgment

1 This reference for a preliminary ruling concerns the interpretation of Article 86 of 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 (OJ 2001 L 311, p. 67), as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 (OJ 2004 L 136, p. 34).

2 The reference was made in the context of criminal proceedings brought by the Anklagemyndigheden (Public Prosecutor) against Mr Damgaard, a journalist, who has been charged with having publicly disseminated information about the properties and availability of a medicinal product the marketing of which is not authorised in Denmark.

Legal context

Directive 2001/83

3 Recitals 2 and 3 in the preamble to Directive 2001/83 state the following:

‘(2) The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.

(3) However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.’

4 According to recital 40 in the preamble to the same directive:

‘The provisions governing the information supplied to users should provide a high degree of consumer protection, in order that medicinal products may be used correctly on the basis of full and comprehensible information.’

5 Recital 45 in the preamble to that directive is worded as follows:

‘Advertising to the general public, even of non-prescription medicinal products, could affect public health, were it to be excessive and ill-considered. Advertising of medicinal products to the general public, where it is permitted, ought therefore to satisfy certain essential criteria which ought to be defined.’

6 Title III of Directive 2001/83, as amended by Directive 2004/27 (‘Directive 2001/83’), concerns the placing of medicinal products on the market, whilst Title IV thereof lays down rules governing their manufacture and importation. Title VII of that directive lays down rules governing wholesale distribution of medicinal products.

7Article 86 of Directive...