OPINION OF ADVOCATE GENERAL

RUIZ-JARABO COLOMER

delivered on 13 February 2007 (1)

Case C‑374/05

Gintec International Import-Export GmbH

v

Verband Sozialer Wettbewerb eV

(Reference for a preliminary ruling from the Bundesgerichtshof, (Germany))

(Directive 2001/83/EC– Medicinal products for human use – Advertising – Complete harmonisation – Advertising to the general public – Prohibitions and restrictions – Advertising with a prize draw and claims of recovery – Interpretation of Articles 87(3) and 90(j))

I –  Introduction

1.     The various ingredients which go into the recipe for a preliminary ruling are clearly enough set out in the European Union cookbook, but theory comes up against the varying circumstances which apply each time the dish is prepared, as the chosen heat source, the pans, the condition and origin of the ingredients and even the state of mind of whoever is cooking are always different. While the national courts take primary responsibility for the dish, the Court of Justice merely provides them with the all-important Community seasoning, without interfering in matters which do not concern it. Nevertheless, the European and national elements frequently become mixed up and, to allow them to perform their functions, each must absorb and refine the flavours of the other.

2.     The present reference has more dimensions than are first apparent. It puts forward three questions, but between the first and the second questions further queries arise to which, the Court of Justice must give an answer that will determine the outcome of the case.

3.     The First Civil Chamber of the Bundesgerichtshof (Federal Court of Justice) would like to know whether the rules on advertising contained in 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, (2) rather than setting out to harmonise by setting minimum standards, devises a complete system so that the Member States have no room for manoeuvre and cannot add further restrictions to those indicated by the directive (first question). However, as German legislation includes prohibitions which do not feature in the European rules, in reality what is sought to be established is whether and to what extent Community law rejects these national prohibitions.

4.     If the first question is answered in the affirmative, the German court entertains two further doubts (the second question): first, whether surveys about the overall evaluation of a medicinal product carried out among non-professionals constitute an improper and misleading reference to a ‘claim of recovery’ within the meaning of Article 90(j) of Directive 2001/83; the second doubt relates to Article 87(3) and whether it can be characterised as a ‘catch-all’ provision which would prohibit a monthly Internet draw for a small prize. The German court is therefore taking it for granted that these provisions have direct effect, which is questionable, and consequently it may be desirable to address the first question in a manner which allows us to marry in the national legislation applicable in the main proceedings, thereby filling a vacuum which would be to nobody’s advantage.

5.     It falls to the Court of Justice, like a reliable kitchen hand who is unable to create a whole meal but acts as the chef’s adviser, to provide the Bundesgerichtshof with some guidelines on the interpretation of its own national law by offering it a valuable tool for resolving the dispute.

6.     Finally, the referring court seeks guidance on whether Directive 92/28/EEC, (3) Article 2(3) and Article 5(j) of which are repeated in Article 87(3) and Article 90(j) of Directive 2001/83, should be treated in the same way (the third question).

II –  The legal framework

A –    Directive 2001/83

7.     The aim of this Directive, which was adopted under Article 95 EC (formerly Article 100a of the EC Treaty), is ‘to safeguard public health’ (recital 2) without hindering the development of the pharmaceutical industry or trade in medicinal products within the Community (recital 3).

8.     It seeks to remove hindrances to such trade caused by disparities between national provisions by approximating national provisions (recitals 4 and 5), and the advertising of medicinal products is no exception to this, since Member States have adopted specific measures in this area, leading to disparities which are likely to have an impact on the functioning of the internal market (recital 43).

9.     Title VIII (4) defines ‘advertising of medicinal products’ (Article 86) and, having prohibited advertising of medicinal products which do not have a marketing authorisation (Article 87(1)), provides that such advertising should encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties, and should not be ‘misleading’ (Article 87(3)).

10.   Advertising of medicinal products which are only available on medical prescription is prohibited (Article 88(1)(a)), (5) while advertising of those which, by virtue of their composition and purpose, can be obtained without a prescription (Article 88(2)) is permitted.

11.   Even so, the legislature shows great concern for the harmful effect that such advertising might have on public health if it were excessive or ill-considered and, consequently, undertakes to define certain essential criteria (recital 45).

12.   To this end, the Directive prohibits the direct distribution of medicinal products for promotional purposes (recital 46 and Article 88(6)).  (6)

13.   More specifically, Article 89 deals with the form and minimum content of advertising to consumers and Article 90 prohibits the inclusion of any material which:

‘…

(f)      refers to a recommendation by scientists, health professionals or persons who are neither of the foregoing but who, because of their celebrity, could encourage the consumption of medicinal products;

…

(j)      refers, in improper, alarming or misleading terms, to claims of recovery;

…’

B –    The German legislation

14.   The Gesetz gegen den unlauteren Wettbewerb (7) (Law against unfair competition (former version) (‘UWG’)) provides that acts which prejudice competitors, consumers or other parties active in the market are illegal (Paragraph 4); thus, a party acts unfairly when it infringes legal provisions which regulate market conduct in the interest of parties active in the market (Paragraph 4(11)).

15.   One such piece of legislation is the Gesetz über die Werbung auf dem Gebiete des Heilwesens (8) (the Heilmittelwerbegesetz or Law on advertising medicines (‘HWG’)), Paragraph 11(1) of which prohibits advertising outside professional circles:

‘…

11.      using statements made by third parties, in particular using statements of gratitude, recognition or recommendation, or by reference to such statements;

…

13.      using competitions, prize draws, lotteries or other procedures, the outcome of which is dependent on chance;

…’.

III –  The facts, the main proceedings and the questions referred for a preliminary ruling

16.   Gintec International Import-Export GmbH (‘Gintec’) markets various ginseng preparations (9) registered in the Federal Republic of Germany as over-the-counter medicinal products.

17.   In May 2000 it published leaflets on a ‘consumer survey evaluation’, which set out information using various different headlines:

–       ‘High intensity of use … 41% of customers have used Gintec’s Roter Ginseng regularly for five years or longer …’.

–       ‘Long-term use of the medication and customer loyalty … Almost half of all users decided on long-term use of the medication because the product did them good and they still take Gintec’s Roter Ginseng i.e. daily …’.

–       ‘Reasons for taking Gintec’s Roter Ginseng. Two thirds of those questioned use Gintec’s Roter Ginseng to reinforce general good health. In addition, individual complaints such as heart and circulatory problems were mentioned by half of all those questioned …’.

–       ‘Overall evaluation of Gintec’s Roter Ginseng. Half of all customers are “very satisfied” with the product and another third consider the product to be “good”. Only 2% stated that they noticed no improvement …’.

18.   On 28 May 2000 Gintec announced on its website a monthly draw for a pack of ‘Roter Imperial Ginseng von Gintec Extraktpulver’ (Red Imperial Ginseng extract powder), the participant needing only to complete and send off a questionnaire.

19.   Verband Sozialer Wettbewerb (Association for the Defence of Free Competition) brought legal proceedings against Gintec on the basis that the two advertising campaigns infringed Paragraph 11(1)(11) and 11(1)(13) of the HWG respectively and, on appeal, it obtained a judgment from the Oberlandesgericht (Higher Regional Court) Frankfurt am Main prohibiting them.

20.   Gintec appealed on a point of law to the Bundesgerichtshof, which has stayed proceedings in order to refer the following questions to the Court of Justice for a preliminary ruling:

‘1.      Do the provisions of Directive 2001/83, concerning a reference to statements of third parties who lack professional knowledge of the subject and advertising with a prize draw, set not only a minimum standard for the prohibition on advertising of a medicinal product to the general public, but also a definitive maximum standard?

2.      If the answer to the first question is in the affirmative:

(a)      Is there an improper or misleading reference to a “claim of recovery” within the meaning of Article 90(j) of Directive 2001/83, where the advertiser reports the result of a survey of third parties who lack professional knowledge of the subject with a positive overall evaluation of the medicinal product advertised, without attributing the evaluation to individual fields of application?

(b)      Does the lack of an express prohibition on advertising with a prize draw in Directive 2001/83 mean that this is basically permitted, or does Article 87(3) of Directive 2001/83 contain a catch-all provision on which the prohibition of internet advertising with a monthly low-value prize draw may be based?

3.      Are the above questions to be answered analogously in respect of Directive 92/28/EEC?’

IV –  The proceedings before the Court of Justice

21.   The order of the Bundesgerichtshof was lodged at the Registry of the Court of Justice on 12 October 2005. The parties to the main proceedings, the Commission and the German, Slovenian and Polish Governments have submitted written observations and, with the exception of the representative of the Slovenian Government, their representatives appeared at the hearing on 7 December 2006.

V –  Analysis of the questions referred for preliminary ruling

A –    The first question: full harmonisation

22.   The essence of this referral is the nature of the harmonisation sought by the rules on the advertising of medicinal products contained in Directive 2001/83. It is not clear whether these rules are exhaustive, with no leeway at all for the national legislature, or whether they lay out a minimum programme, leaving the Member States free to adopt other rules and tighter restrictions.

23.   The Commission, the Slovenian Government and Gintec opt for the first of these alternatives, while Verband Sozialer Wettbewerb and the German (10) and Polish Governments advocate the second, paradoxically using the same criteria of interpretation to point to opposing outcomes.

24.   If the Directive is interpreted in the light of its objectives, its overall system and the general sense of its provisions and with regard to the legal basis which underpins it, support is found for the view that it establishes a system which allows no room for innovation beyond what is expressly provided for.

1.      The legal basis of Directive 2001/83

25.   Article 95 EC, which constitutes the legal basis for Directive 2001/83, provides an initial indicator in support of that view: Article 95(1) enables the Council, acting in accordance with the procedure referred to in Article 251 EC (formerly Article 189b of the EC Treaty) and after consulting the Economic and Social Committee, to adopt the measures for the approximation of the provisions laid down by law, regulation or administrative action in Member States which have as their object the establishment and functioning of the internal market.

26.   It has been held that that provision (11) is intended to improve that market (12) and to eliminate barriers to trade arising from differences between national rules, (13) albeit that a mere abstract risk that such barriers may emerge is not sufficient to justify such Community intervention; the emergence of such barriers must be likely and the measure in question must be designed to prevent them. (14)

27.   The Slovenian and German Governments are correct in noting that Article 95 EC gives no guidance as to what type of harmonisation it is advocating, (15) but it seems contradictory that, in an attempt to overcome differences it should open the door to local disparities. (16) The fact that one of the aims of Directive 2001/83 is to safeguard public health (17) does not per se justify stricter national rules since Article 95(3) EC itself requires that harmonisation take as a base a high level of health protection, while Article 152(1) EC (formerly Article 129(1) of the EC Treaty) regards health protection requirements as part of EU policies. (18)

28.   I am obliged to concede, however, that, unlike Article 94 EC (formerly Article 100 of the EC Treaty), Article 95 EC does permit exceptions by allowing Member States to depart from the Community common denominator, although these special situations are subject to a strict procedure, (19) which was not observed in this case.

29.   Article 153 EC (formerly Article 129a of the EC Treaty) significantly supports the approach I am advocating. Under that article consumer protection is to be attained through approximation measures based on Article 95 EC, as well as through other measures which support, supplement and monitor the policies of the Member States (Article 153(3)), adopted by the Council in accordance with Article 251 EC (Article 153(4)). Thus, national initiatives giving a higher level of protection are authorised only under the second limb, from which it can be concluded that the harmonisation under Article 95 EC is maximum harmonisation apart from the exceptions provided for by that provision. In other words, as the Court emphasised in Case C‑52/00 Commission v France, (20) harmonisation under Article 95 EC must be equated with harmonisation under Article 94 EC for these purposes.

2.      Teleological interpretation

30.   Directive 2001/83 seeks to remove barriers to the free movement of medicinal products caused by disparities between national regulations while safeguarding public health (recitals 2 to 4). However, there is nothing to support the argument that, in fulfilling their commitment under Articles 95 and 152 EC to safeguard that collective interest, the Community institutions can adjust downwards and accommodate each Member State’s particular requirements, which, as the EU legislature points out, hinders the achievement of the project. In Joined Cases C‑211/03, C‑299/03 and C‑316/03 to C‑318/03 HLH Warenvertriebs and Orthica (21) the Court stated that, in so far as Directive 2001/83 harmonises the procedures for the production, distribution and use of medicinal products, it is no longer possible for Member States to adopt national measures which restrict the free movement of these goods on the basis of Article 30 EC, in particular on grounds of the protection of health of humans (paragraph 58).

31.   The German Government correctly argues that minimum harmonisation does not always hinder this freedom of movement and does not necessarily entail the fragmentation of the single market. However, if the hindrances to this freedom arise from disparities in national provisions and the aim is to get rid of them by bringing the relevant national rules into line with each other (Recital 5 of Directive 2001/83), there is absolutely no room for national differences and complete harmonisation is essential, particularly if the other objective (the protection of health) is met through common rules.

32.   This approach fits in very well with drugs advertising as, here too, local disparities also have an impact on the functioning of the internal market (Recital 43 of Directive 2001/83). (22)

33.   The exception contained in Recital 42 of Directive 2001/83, which exempts measures adopted pursuant to Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and administrative provisions of the Member States concerning misleading advertising, (23) is not inconsistent with the approach I am putting forward. I accept that the first paragraph of Article 7 of Directive 84/450 (24) allows stricter national rules, but this conduit for national divergence in relation to a general rule (Directive 84/450) cannot be used in respect of a special rule (Directive 2001/83) which attempts to impose uniformity in order to overcome national differences which hinder the market. In other words, the countries of the European Union are permitted to protect their citizens from misleading advertising by constructing higher defences than those provided by the Community, which constitute the lowest common denominator; moreover, when it comes to medicinal products, advertising, whether honest or misleading, must comply with the exhaustive harmonisation provisions contained in Directive 2001/83. Article 7(3) of Directive 84/450 (25) bears out this interpretation by providing that the Directive shall apply without prejudice to Community provisions on specific products or services.

34.   Thus, both the legal basis and the objectives of Directive 2001/83 lend weight to the point of view that the legislative harmonisation that it brings about is comprehensive in its nature. The text and overall scheme of the Directive are also in line with this approach.

3.      Systematic and textual criteria

35.   Having defined ‘advertising of medicinal products’ in Article 86, Directive 2001/83 goes on to set its boundaries by directing the Member States to prohibit advertising of unauthorised products (Article 87(1)). As far as licensed products are concerned, the directive distinguishes between advertising directed at patients, which is absolutely prohibited (‘Member States shall prohibit’) when it is in respect of preparations which are available only on medical prescription (26) or which contain psychotropic or narcotic substances (Article 88(1) and (2)) (27) and, on the other hand, advertising to persons qualified to prescribe such products, which is not, in principle, subject to restrictions of any kind. Direct distribution to consumers for promotional purposes is also prohibited (Article 88(6)). (28)

36.   Having thus delimited advertising in the sector, Directive 2001/83 goes on to restrict it severely by providing that, irrespective of the intended addressee of the advertising, it must encourage the rational use of the medicinal product, by presenting it objectively, without exaggerating its properties or being misleading (Article 87(3)).

37.   When the advertising is directed at potential patients, Directive 2001/83 prescribes the minimum content (name, information for use and an invitation to read the instructions) and the way in which this is to be done (Article 89(1)), as well as setting out excluded material (Article 90). Similar provisions apply to advertising directed at medical professionals (Articles 91, 92 and 96).

38.   Within this well-defined framework, the Member States enjoy a degree of discretion in certain respects. They can ban advertising of medicinal products the cost of which may be reimbursed, even if the directive itself does not impose such a ban (Article 88(3)), and show more flexibility in respect of the minimum information required