Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg.

• Jurisdiction: European Union
• ECLI: ECLI:EU:C:2009:5
• Docket Number: C-140/07
• Celex Number: 62007CJ0140
• Court: Court of Justice (European Union)
• Procedure Type: Reference for a preliminary ruling
• Date: 15 January 2009

Case C-140/07

Hecht-Pharma GmbH

v

Staatliches Gewerbeaufsichtsamt Lüneburg

(Reference for a preliminary ruling from the Bundesverwaltungsgericht)

(Directive 2001/83/EC – Articles 1(2) and 2(2) – Concept of ‘medicinal product by function’ – Product in respect of which it has not been established that it is a medicinal product by function – Account taken of the content in active substances)

Summary of the Judgment

1. Approximation of laws – Medicinal products for human use – Directive 2001/83 – Scope

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 2(2))

2. Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal product by function – Criteria

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 1(2)(b))

3. Approximation of laws – Medicinal products for human use – Directive 2001/83 – Classification of a product as a medicinal product by function – Criteria

(European Parliament and Council Directive 2001/83, as amended by Directive 2004/27, Art. 1(2)(b))

1. Article 2(2) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, must be interpreted as meaning that Directive 2001/83, as amended, does not apply to a product in respect of which it has not been scientifically established that it is a medicinal product by function, without its being possible to exclude that possibility.

(see para. 29, operative part 1)

2. Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, must be interpreted as meaning that, notwithstanding the amendments made to the definition of a medicinal product by Directive 2004/27, the characteristics of the manner in which a product is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail are still relevant to determining whether that product falls within the definition of a medicinal product by function.

(see paras 35, 37, operative part 2)

3. Article 1(2)(b) of Directive 2001/83 on the Community code relating to medicinal products for human use, as amended by Directive 2004/27, must be interpreted as meaning that, apart from the case of substances or combinations of substances intended for the purpose of making a medical diagnosis, a product cannot be regarded as a medicinal product within the meaning of that provision where, having regard to its composition – including its content in active substances – and if used as intended, it is incapable of appreciably restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action. The capacity to restore, correct or modify physiological functions should not lead to the classification as medicinal products by function of products which, while having an effect on the human body, do not significantly affect the metabolism and thus do not strictly modify the way in which it functions.

(see paras 41, 45, operative part 3)

JUDGMENT OF THE COURT (First Chamber)

15 January 2009 (*)

(Directive 2001/83/EC – Articles 1(2) and 2(2) – Concept of ‘medicinal product by function’ – Product in respect of which it has not been established that it is a medicinal product by function – Account taken of the content in active substances)

In Case C‑140/07,

REFERENCE for a preliminary ruling under Article 234 EC from the Bundesverwaltungsgericht (Germany), made by decision of 14 December 2006, received at the Court on 12 March 2007, in the proceedings

Hecht-Pharma GmbH

v

Staatliches Gewerbeaufsichtsamt Lüneburg,

intervening party:

Vertreterin des Bundesinteresses beim Bundesverwaltungsgericht,

THE COURT (First Chamber),

composed of P. Jann, President of the Chamber, M. Ilešič, A. Tizzano, A. Borg Barthet (Rapporteur) and J.-J. Kasel, Judges,

Advocate General: V. Trstenjak,

Registrar: M.-A. Gaudissart, Head of unit,

having regard to the written procedure and further to the hearing on 24 April 2008,

after considering the observations submitted on behalf of:

– Hecht-Pharma GmbH, by C. Sachs, Rechtsanwältin,

– Staatliches Gewerbeaufsichtsamt Lüneburg, by H. Laackmann, acting as Agent,

– the Greek Government, by N. Dafniou, O. Patsopoulou and M. Apessos, acting as Agents,

– the Polish Government, by E. Ośniecka-Tamecka, T. Krawczyk and P. Dąbrowski, acting as Agents,

– the United Kingdom Government, by Z. Bryanston-Cross, acting as Agent, assisted by A. Henshaw, Barrister,

– the Commission of the European Communities, by B. Stromsky, B. Schima and G. Wilms, acting as Agents,

after hearing the Opinion of the Advocate General at the sitting on 19 June 2008,

gives the following

Judgment

1 This reference for a preliminary ruling concerns the interpretation 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), (‘Directive 2001/83’) and, in particular, Articles 1(2) and 2(2) thereof.

2 The reference has been made in the context of proceedings between Hecht-Pharma GmbH (‘Hecht-Pharma’) and the Staatliches Gewerbeaufsichtsamt Lüneburg (Public Authority for the Monitoring of Commercial Activities, Lüneburg) concerning the classification of a product called ‘Red Rice’ as a food additive or a medicinal product for the purposes of its marketing in German territory.

Legal framework

Community rules

3 Article 1(2) of Directive 2001/83, in its original version, provided that the term ‘medicinal product’ was to mean:

‘Any substance or combination of substances presented for treating or preventing disease in human beings.

Any substance or combination of substances which may be administered to human beings with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings …’

4 The present version of Article 1(2) of Directive 2001/83 provides that the term ‘medicinal product’ means:

‘(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or

(b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis’.

5 Article 2(1) and (2) of Directive 2001/83 provides as follows:

‘1. This Directive shall apply to medicinal products for human use intended to be placed on the market in Member States and either prepared industrially or manufactured by a method involving an industrial process.

2. In cases of doubt, where, taking into account all its characteristics, a product may fall within the definition of a “medicinal product” and within the definition of a product covered by other Community legislation, the provisions of this Directive shall apply.’

6 Recitals 2, 3, 4 and 7 in the preamble to Directive 2004/27 state that:

‘(2) The Community legislation so far adopted has made a major contribution to the achievement of the objective of the free and safe movement of medicinal products for human use and the elimination of obstacles to trade in such products. However, in the light of the experience acquired, it has become clear that new measures are necessary to eliminate the remaining obstacles to free movement.

(3) It is therefore necessary to align the national laws, regulations and administrative provisions which contain differences with regard to the basic principles in order to promote the...