C-322/01

1. Authorisation of medicinal products I -14894

(a) Previous legal position: Directive 65/65/EEC as amended by Directive 93/39/EEC 1-14894

(b) Present legal position: Directive 2001/83/EC I -14894

2. Advertising of medicinal products I -14895

(a) Previous legal position: Directive 92/28/EEC I -14895

(b)Present legal position: Community code 1-14897

IV — Questions referred for a preliminary ruling I -14905

V — The first question I -14907

1 — Original language: German.

I - 14890

DEUTSCHER APOTHEKER VERBAND

A — Unauthorised medicinal products: Questions 1, 1(a) and 1(b) I-14908

(i) Submissions of the parties I -14910

(ii) Assessment I-14910

— Examples of selling arrangements in existing case-law I-14911

— Validity for all economic operators who carry on their business in

their home country I-14913

— Impact on sales of products I-14913

— Justification for the measure I -14921

— Proportionality of the measure I -14921

— Appropriateness of the national measure I -14921 I - 14891

OPINION OF MRS STIX-HACKL — CASE C-322/01

— Necessity of the national measure I -14922

— Reasonableness of the national measure I -14922

(i) Assessment with regard to the objectives of the prohibition on mail order I -14926

— Lack of expert advice? I -14926

— Need to guarantee patient protection in the delivery of medicinal products I -14928

— Need to guarantee a comprehensive supply that meets require- ments I-14929

(ii) Burden of proof on the Member State in question I-14929

(iii) Interim conclusion on Question 1(c) I-14930

(i) Prohibition on medicinal products by mail order I-14933 (ii)Prohibition on advertising medicinal products that are not auth- orised in the importing State I -14935

(iii) Prohibition on advertising prescription medicinal products I -14936

I - 14892

DEUTSCHER APOTHEKERVERBAND

2. Question 2(a) — Internet presentation as advertising to the general public? I -14936 (a) Submissions of the parties I -14937 (b) Assessment I -14938 3. Interim conclusion I -14941 B — Question 2(b): Parts of the internet presentation as trade catalogue and/or price list? 1-14941 1. Submissions of the parties I -14942 2. Assessment I -14942 3. Interim conclusion I -14944 C — Freedom to provide services I -14944 1. Submissions of the parties I -14944 2. Assessment I -14945 VII — The third question I -14947 1. Submissions of the parties I -14947 2. Assessment I -14947 VIII — Conclusion I-14948

I — Introduction may restrict the supply of medicinal prod- ucts 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 1. The present reference for a preliminary of the principle of free movement of goods ruling concerns 'internet pharmacies' and and a number of provisions of secondary the question whether the Member States law.

2. The central provisions on the authori- sation 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 (b) Present legal position: Directive administrative action relating to propri- 2001/83/EC etary medicinal products, 2as 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 3. With effect from 18 December 2001, medicinal p r o d u c t s 3 (hereinafter: Directive 65/65 was replaced by Directive 65/65). Article 3 of that directive Directive 2001/83/EC of the European provides: 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 pro- vides: '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 'No medicinal product may be placed on the market of a Member State unless a

2 — OJ, English Special Edition 1965-1966, p. 24. 3 —OJ 1993 L 214, p. 22. 4 —OJ 2001 L 311, p. 67.

I - 14894

DEUTSCHER APOTHEKERVERBAND

marketing authorisation has been issued by consumption of medicinal products; it shall the competent authorities of that Member include in particular: State in accordance with this Directive or an authorisation has been granted in accordance with Regulation (EEC) No 2309/93.' — the advertising of medicinal products to the general public,

6. Article 2(1) states:

(4) The following are not covered by this Directive: 'Member States shall prohibit any advertis- ing of a medicinal product in respect of which a marketing authorisation has not been granted in accordance with Commu- nity law.'

— the labelling of medicinal products and the accompanying package leaflets, which are subject to the provisions of Directive 92/27/EEC; 7. Article 3 provides inter alia:

' 1 . Member States shall prohibit the adver- — correspondence, possibly accompanied tising to the general public of medicinal by material of a non-promotional products which: nature, needed to answer a specific question about a particular medicinal product;

— are available on medical prescription only, in accordance with Directive 92/26/EEC, — factual, informative announcements and reference material relating, for example, to pack changes, adverse- reaction warnings as part of general drug precautions, trade catalogues and — contain psychotropic or narcotic sub- price lists, provided they include no stances, within the meaning of the product claims; international conventions, I - 14896

DEUTSCHER APOTHEKER VERBAND

I - 14897

OPINION OF MRS STIX-HACKL — CASE C-322/01

3. Distance sales information society services, in particular electronic commerce, in the Internal Mar- ket ('Directive on electronic commerce', 7 hereinafter: E-commerce directive). 12. The provisions applicable to distance sales can be found in Directive 97/7/EC of the European Parliament and of the Coun- cil of 20 May 1997 on the protection of consumers in respect of distance contracts (hereinafter: Directive 97/7). 6 15. The 11th recital of the E-commerce directive provides:

13. Article 14 of Directive 97/7 provides:

'This Directive is without prejudice to the level of protection for, in particular, public health and consumer interests, as estab- 'Member States may introduce or maintain, lished by Community acts.... that same in the area covered by this Directive, more Community acquis, which is fully appli- stringent provisions compatible with the cable to information society services, also Treaty, to ensure a higher level of consumer embraces in particular Council Directive... protection. Such provisions shall, where and Council Directive 92/28/EEC of appropriate, include a ban, in the general 31 March 1992 on the advertising of interest, on the marketing of certain goods medicinal products'. or services, particularly medicinal products, within their territory by means of distance contracts, with due regard for the Treaty.'

16. Article 1 of that directive includes the following provisions:

(i) necessary for one of the following reasons: 3. This Directive complements Community law applicable to information society ser- vices without prejudice to the level of protection for, in particular, public health and consumer interests, as established by Community acts and national legislation implementing them in so far as this does ..., not restrict the freedom to provide infor- mation society services.'

— the protection of public health,

17. Article 3 provides inter alia as follows:

...,

'2. Member States may not, for reasons falling within the coordinated field, restrict the freedom to provide information society — the protection of consumers, services from another Member State. including investors;

I - 14899

I - 14900

DEUTSCHER APOTHEKERVERBAND

22. The AMG also lays down a prohibition exceeding the amount needed for normal on importation. The relevant rules are laid personal use in a Member State of the down in the section on 'Import and European Community or in another State Export', in Paragraph 73. Paragraph 73(1) party to the Agreement on the European includes the following provision: Economic Area'.

'(1) Medicinal products which are subject 24. The referring court interprets the to authorisation or registration may be national provisions as meaning that the brought into the territory in which this Law exception laid down in Paragraph 73(2), applies, with the exception of duty-free point 6a of the AMG does not apply to the areas other than the island of Helgoland, defendant in the present case. Both a only if they are authorised or registered for systematic interpretation of that exception being placed on the market in that terri- and the purpose of the law as revealed by tory, or if they have been exempted from the background legal materials point to a the obligation to be so authorised or restrictive interpretation of that provision, registered, and subject to the following which is not intended to cover commercial, conditions: cross-border volume trade in medicinal products for human use on the basis of orders placed on the internet.

where the product has been imported from a Member State of the European Commu- nities or from another State party to the Agreement on the European Economic 25. In the view of the German Govern- Area, the recipient must be a pharmaceuti- ment, the insertion of the terms 'without a cal business, a wholesaler or a veterinarian commercial or professional intermediary' is or must run a pharmacy, or intended to prevent the individual import of unauthorised medicines being extended in such a way that the authorisation requirement is circumvented.

'(1) Any advertising the aim of which is to sell by mail order medicinal products which may be supplied only by pharmacies is illegal. This prohibition does not apply to (2) Medicinal products intended to treat, in advertising relating to the supply of medici- humans, insomnia or psychological dis- nal products in the cases provided for in orders, or which are psychotropic, may Paragraph 47 of the AMG. not be advertised other than in professional circles.'

(2) Any advertising the aim of which is to sell medicinal products by way of tele- shopping or particular medicinal products by way of individual importation as described in Paragraph 73(2), point 6a, or Paragraph 73(3) of the AMG is also illegal.' III — Facts and main proceedings

28. In the view of the German Govern- ment, the intention is thus to prevent the 29. The duties of the Deutsche Apotheker- individual importation of unauthorised verband e.V. (hereinafter: the Apotheker- medicinal products being extended by verband) in accordance with its constitu- advertising measures in such a way that it tion include the protection and promotion amounts to circumvention of the rules on of the economic and social interests of authorisation. pharmacists. Its members are the regional associations and organisations of pharma- cists, which in turn represent more than 9 — BGBl. 1994 I, p. 3068. 19 000 pharmacy directors. I - 14902

DEUTSCHER APOTHEKER VERBAND

30. 0800 DocMorris NV (hereinafter: Doc- macy', 'Health forum', 'About us', 'Con- Morris) is a Netherlands pharmacy estab- tact' and 'Help'. In the 'Patients' Forum', lished in Kerkrade, the Netherlands. Jac- consumers can exchange views over the ques Waterval is a pharmacist and one of internet. German, English or Dutch can be the legal representatives of DocMorris. He chosen as the language used. Consumers is also one of the initiators of the 'internet also have the possibility of obtaining health pharmacy', one of the leaders of its edi- advice from the advisory committee of torial team, and the head of its advisory experts at the 'internet pharmacy'. Gen- committee of experts. erally, the consumer can contact DocMor- ris and Mr Waterval not only via the internet, but also on a freephone telephone number or by letter.

I - 14903

OPINION OF MRS STIX-HACKL — CASE C-322/01

and Mr Waterval as available only on 34. DocMorris and Mr Waterval take the prescription where it is classified as such view that their activity is in fact permissible in the Netherlands or in the Member State under national law, but that, in any event, a in which the consumer resides. Medicines national prohibition would be contrary to of this type are supplied only on production Community law. of the original prescription.

35. The Landgericht questioned in particu- lar whether, in view of the time which has since elapsed and the changed requirements for the authorisation of medicinal products 32. Delivery itself can take a number of for human use in the Member States of the forms. The customer may collect the order European Community, the principles set in person from DocMorris. Alternatively, out in the judgment in Ortscheit 100 are still they may, at no additional cost, use a applicable. courier service recommended by DocMor- ris to collect the order and take it to the address given by the recipient. Finally, the customer can use another courier service at their own expense.

1. Are the principles of the free movement of goods under Article 28 et seq. EC infringed by national legislation which prohibits human medicines, which are required to be handled only through pharmacies, from being imported com- mercially from other EU Member States in mail-order business through authorised pharmacies on the basis .of 37. The Landgericht did not consider itself individual orders placed by consumers to be bound by the judgment in Ortscheit, over the internet? because, in the first place, that decision concerned only the prohibition in Paragraph 8(2) of the HWG, which is not relevant here, and, secondly, because, in the light of the above considerations, the con- cept of 'advertising' in the case of the (a) Does such a national prohibition internet presentation of a pharmacy might constitute a measure having equiv- need to be assessed separately. In that alent effect to a quantitative connection, the question arises whether restriction on imports within the the recent extensive harmonisation of pro- meaning of Article 28 EC? cedures for the authorisation of medicinal products for human use and the intended Community law authorisation of advertis- ing of non-prescription medicinal products require a different, more restrictive defini- (b) If it does, is Article 30 EC to be tion of 'advertising' in Community law. It interpreted as meaning that a is possible that the principle of free cross- national prohibition designed to border movement of goods may not be protect the health and life of effectively realised if DocMorris' internet humans is justified if, before pre- presentation were to be made wholly or scription medicines are sent out, a partially impossible on the ground that it doctor's original prescription must was carrying on unlawful advertising for have been produced to the phar- medicinal products for human use. macy sending out the medicines? In

I - 14906

DEUTSCHER APOTHEKERVERBAND

order, and/or other parts of the national prohibition on medicinal products internet presentation of a phar- 'being imported commercially from other macy of an EU Member State, are EU Member States in mail-order busi- comparable with trade catalogues ness' 11 (hereinafter: the prohibition on and/or price lists within the mean- mail order) infringes the principle of free ing of Article 1(4) of Directive movement of goods. It should be pointed 92/28/EEC? out in this regard that the Court does not have jurisdiction, in preliminary ruling proceedings under Article 234 EC, to give a ruling on the compatibility of national law with Community law. However, it does have jurisdiction to supply the national court with a ruling on the inter- pretation of Community law so as to enable that court to determine whether such compatibility exists in order to decide 3. If some aspects of the internet presen- the case before it. 12 tation of a pharmacy of an EU Member State infringe provisions concerning the advertising of medicines, is it to be inferred from Articles 28 and 30 EC that cross-border trade in medicines which does take place with the help of such a presentation must be regarded as legally permissible despite the pro- hibited advertising, in order more effectively to implement the principle of the free movement of goods across borders?

40. As is clear from Question 1(c), Ques- tions 1, 1(a) and 1(b) concern medicinal products not authorised in Germany. On the other hand, Question 1(c) relates to V — The first question medicinal products authorised in Germany. This distinction forms the basis for the following structure.

4 1 . DocMorris takes the view that Article 14 of Directive 97/7 cannot justify a general prohibition on mail-order sales of medicinal products, because that provision expressly stipulates that due regard must be had to the provisions of higher-ranking 46. The Austrian Government refers to the primary law. option the Member States have of pro- hibiting marketing under Article 14 of Directive 97/7. Since the marketing of medicinal products is not fully harmonised, the Member States still have the power to 42. The Apothekerverband argues that the adopt national rules. detailed rules on the sale and delivery of medicinal products have not yet been har- monised with regard to the prescription requirement and internet-based mail order trade.

47. The Commission takes the view that 43. In its observations on secondary law, the prohibition on mail order is covered by the German Government refers to Article 3 of Directive 65/65 and/or Article 6 Directive 65/65 and the Community code, of the Community code. and the prohibition on bringing into circu- lation unauthorised medicinal products laid down therein. The prohibition on mail 13 — Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by law, order is intended to prevent the circum- regulation or administrative action in Member States concerning the pursuit of television broadcasting activities vention of that prohibition. (OJ 1989 L 298, p. 23).

I - 14908

DEUTSCHER APOTHEKERVERBAND

50. This is the case with Article 14 of Directive 97/7, to which some of the parties 2. Member States' regulatory powers: have expressly referred. That provision Limits deriving from free movement of expressly states that the Member States goods may 'ban... the marketing of certain goods

14 — See Case C-150/88 Parfümerie-Fabrik [1989] ECR 3891, paragraph 28, Case C-37/92 Vanacker and Lesage [1993] CR I-4947, paragraph 9, Case C-324/99 DaimlerCh- 53. In view of the fact that secondary law rysler [2001] ECR I-9897, paragraph 32, and Case C-99/01 Unhart and Biffl [2002] ECR I-9375, paragraph contains relevant provisions on trade in 18. medicinal products, but free movement of

I - 14909

OPINION OF MRS STIX-HACKL — CASE C-322/01

goods still remains an area of application, not affect sales of domestic and foreign consideration must be given below to free medicinal products in the same way. movement of goods. First of all, the ques- Because of the strict rules of the German tion must be raised whether the contested law governing pharmacies, direct sales have German provisions actually fall within the fundamental importance and the prohib- scope of free movement of goods. It must ition on mail order is a measure having then be examined whether a restriction equivalent effect. exists and, if so, whether this can be justified.

56. The Apothekerverband, the French and Austrian Governments and the Commis- sion classify the prohibition on mail order (a) Applicability of free movement of as a simple selling arrangement. goods: prohibition on mail order as a selling arrangement?

59. In order to be covered by the exception laid down by the Keck formula, national measures must satisfy the following requirements. First of all, they must apply to all relevant traders operating within the national territory (universality). 16 Secondly 61. The Court has previously included the they must affect in the same manner, in law following national measures under the and in fact the marketing of domestic Keck formula: time restrictions, such as products and of those from other Member the ban on Sunday trading; 19 restrictions States 17 (neutrality). on the persons who offer goods for sale and on the persons from whom they may be obtained, such as the prohibition on the marketing other than by pharmacies of processed milk for infants; 20 the prohib- ition on the sale of tobacco products other than by specially authorised retailers 2 1 and the prohibition on obtaining beverages from anyone other than a holder of a production or wholesale licence. 22 Fur- 60. It is clear from these criteria that only thermore, the Court has recognised a certain selling arrangements are covered by prohibition on pharmacists advertising the Keck formula, although the case-law products usually sold in pharmacies outside must not be misinterpreted as meaning that the pharmacy 23 and a prohibition on tele- there is a so-called third category. 18 There vised advertising in the distribution sector are logically only two categories of cases: as selling arrangements within the meaning cases covered by the Keck formula and of the Keck formula. 24 Other selling cases not covered by it.

62. According to the Court's case-law, the Keck formula does not cover, first of all, national measures that are designed to regulate trade in goods between Member States. 27 64. This is particularly clear in the TK- Heimdienst judgment, which relates to legislation that requires certain undertak- ings 'who already have a permanent estab- 63. Secondly, the Court has not subsumed lishment in another Member State and who under the Keck formula — expressly or wish to sell their goods on rounds in a implicitly — national measures that particular administrative district... to set up impose additional costs on the imported or purchase another permanent establish- goods. 28 This relates primarily to measures ment in that administrative district or in an which necessitate the adaptation of the adjacent municipality, whilst local econ- intrinsic characteristics, such as composi- omic operators already meet the require- tion, or the external characteristics, such as ment as to a permanent establishment. the designation or packaging, of imported Consequently, in order for goods from products. 2 9 The question of costs therefore other Member States to enjoy the same access to the market of the Member State of importation as domestic goods, they have 25 — This follows a contrario from the judgments in Case to bear additional costs'. 31 C-470/93 Mars [1995] ECR I-1923 and in Case C-368/95 Familiapress [1997] ECR I-3689. 26 — Case C-63/94 Belgapom [1995] ECR I-2467. 27 — Joined Cases C-267/91 and C-268/91 (cited in footnote 15), paragraph 12, and Case C-412/93 (cited in footnote 24), paragraph 19. 28 — C a s e C-323/93 Crespelle [1994] ECR I-5077, paragraph 29, Case C-189/95 (cited in footnote 22), paragraph 7 1 , and Case C-368/95 (cited in footnote 25), paragraph 12. 29 — Advocate General Van Gerven in his Opinion in Joined Cases C-401/92 and C-402/92 (judgment cited in footnote 19); Hénin (cited in footnote 18), 71 et seq.; see also Gormley, ' T w o years after Keck', Fordham International Law Journal, 1996, 866 (880); Greaves, 'Advertising restrictions and the free movement of goods and services', European Law Review, 1998, 305 (310 and 318); Heer- mann, 'Artikel 30 EGV im Lichte der "Keck"-Rechtsprec- hung', Gewerblicher Rechtsschutz und Urheberrecht: 65. It is therefore necessary to examine Internationaler Teil, 1999, 579 (585). below whether the requirements of the O n the other hand, see Mattera, 'De l'arrêt "Dassonville" à l'arrêt "Keck": l'obscure clarté d'une jurisprudence riche Keck formula are satisfied. en principes novateurs et en contradictions', Revue du marché unique européen, 1994, 117 (149), who opposes the argument that any adaptation to satisfy a rule of the importing State is regarded as an impairment. Critical of costs as a general criterion: Rolf Sack, 'Staatliche Wer- 30 — Picod (cited in footnote 17), p. 188 et seq. bebeschränkungen und die Art. 30 und 5 9 EG-Vertrag', Wettbewerb in Recht und Praxis, 1998, 103 (107). 31 — Case C-254/98 TK-Heimdienst [2000] ECR I-151, para- graph 2 6 .

32 — Case C-292/92 (cited in footnote 23), paragraph 23, Joined 34 — Case C-320/93 (cited in footnote 10), paragraph 10. Cases C-401/92 and C-402/92 (cited in footnote 19), 35 — Joined Cases C-267/91 and C-268/91 (cited in footnote paragraph 14, and Case C-412/93 (cited in footnote 24), 15), paragraph 13. paragraph 23. 36 — Case C-292/92 (cited in footnote 23), paragraph 20. 33 — Case C-292/92 (cited in footnote 23), paragraph 23, Joined Cases C-401/92 and C-402/92 (cited in footnote 19), 37 — Case C-412/93 (cited in footnote 24), paragraph 20. paragraph 14, and Case C-412/93 (cited in footnote 24), 38 — Advocate General Lenz also disagrees in his Opinion in paragraph 23. Case C-391/92 (judgment cited in footnote 20), point 20.

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OPINION OF MRS STIX-HACKL — CASE C-322/01

that the opening of a pharmacy in Ger- 73. However, as will be seen below, an many, i.e. a domestic establishment, is the interpretation of such a central rule of only means of marketing medicinal prod- Community law as free movement of ucts, preferential treatment would be given goods, that is to say Article 28 EC, cannot to domestic — German — pharmacies, be limited to a mechanical application of because they already have such an estab- the two traditional requirements laid down lishment. 39 in the Keck formula.

— Decisive factor: impact on market access

71. Lastly, the fact that the present case differs from the situation in TK-Heimdienst in that the prohibition on mail order applies to all pharmacies and there are no 74. The two — traditional — require- exceptions for pharmacies established ments of the Keck formula are, strictly domestically suggests that the Keck for- speaking, only expressions of the general mula has been satisfied. German law pro- requirement that the measure should be vides for a general prohibition on internet 'not by nature such as to prevent... access marketing. to the market or to impede access any more than it impedes the access of domestic products'. 40 This is therefore neither a derivative, nor a third requirement, but, as it were, the — overriding — general criterion. 41

78. The decisive factor should therefore be whether or not a national measure signifi- cantly impedes access to the market. This view has been supported not only by influential figures in legal doctrine, 45 but also by the Court itself — or at least the trend has been to that effect.

79. Thus, the Court has found, with regard to free movement of goods, 'that a prohib- ition of advertising... would render com- mercialisation, and consequently access to 76. The present case shows that the two the market for those goods, appreciably requirements of the Keck formula — inter- more difficult'.46 With regard to freedom preted narrowly — in particular the cri- to provide services, the Court has stated terion of domestic and foreign goods being that a prohibition that directly affects affected in the same manner, are not access to the market in services is capable effective in the case of strict, i.e. very of hindering intra-Community trade in restrictive national measures, even if those national measures are selling arrange- ments. 42 For example, rules on distribution channels can restrict market access in 44 — Cf. Advocate General Elmer in his Opinion in Case exactly the same way as product rules. 43 C-189/95 Franzén (judgment cited in footnote 22). 45 — See, for example, Advocate General Jacobs in his Opinion in Case-412/93 (judgment cited in footnote 24). See also Dauses, 'Die Rechtsprechung des EuGH zum Verbraucherschutz und zur Werbefreiheit im Binnen- 42 — Problem highlighted by Gormley (cited in footnote 29), markt', Europäische Zeitschrift für Wirtschaftsrecht, 884 et seq., and Oliver, 'Some further reflections on the 1995, 425 (428); Rolf Sack, (cited in footnote 29), 109: scope of articles 28-30 (ex 30-36) EC', Common Market the articles in Schwarze (ed.), Werbung und Werbeverbote Law Review, 1999, 783 (795). im Lichte des europäischen Gemeinschaftsrechts, 1999; Weatherill, 'After Keck: some thoughts on how to clarify 43 — Schwintowski, 'Freier Warenverkehr in europäischen Bin- the clarification', Common Market Law Review, 1996, nenmarkt: eine Fundamentalkritik des EuGH zu Art. 28 885 (897). EGV', in: Systembildung und Systemlücken in Kernge- bieten des europäischen Privatrechts, 2000, 457 (468). 46 — Case C-337/95 Dior [1997] ECR I-6013, paragraph 51.

83. National measures that channel prod­ ucts to certain locations, for example reserving the distribution of medicinal products — in the case at issue — in principle for pharmacies are distribution 81. The approach thus taken here, focusing rules in an extreme form. It is not necessary on the impact on market access, cannot, to examine here whether it is important however, be construed as meaning that the that the measures have the purpose of 53 or crucial factor is the extent of the impact of 54 merely can give rise to channelling. 5 the national measure. 0In contrast with a de minimis provision, such as in compe­ 51 — With regard to the contrast see Oliver (cited in footnote 42), 799. 47 —Case C-384/93 Alpine Investments [1995] ECR 1-1141, 52 — See Advocate General Jacobs in his Opinion in Joined paragraphs 35 and 38. Cases C-34/95 to C-3Ć/95 De Agostini and TV-Shop [1997) ECR 1-3843. 48 — Case C-76/90 Säger |1991) ECR 1-4221, paragraph 12. 53 — With regard to such a rule see Advocate General Van 49 — Krock, Der Einfluß der europäischen Grundfreiheiten am Gerven in his Opinion in Joined Cases C-401/92 and Beispiel der Arzte und Arzneimittel, 1998, 200. C-402/92 (judgment cited in footnote 19), point 22, see 50 — For such an alternative solution see Rolf Sack, 'Staatliche also Thumher/Hohensinner (cited in footnote 39), 496. Regelung so genannter " Verkaufsmodalitäten" und Art. 30 54 — Case C-387/93 (cited in footnote 21, paragraph 43); EG-Vertrag', Europäisches Wirtschafts- Sc Steuerrecht, Advocate General Lenz in his Opinion in Case C-391/92 1994, 37 (45). (judgment cited in footnote 20), point 19.

85. In the present case, however, not only is distribution reserved for a certain group of traders, but a whole form of distribution 88. The contested prohibition applies to is prohibited. The contested German rules just one form of distribution, 5 7but it therefore go further than the provisions at cannot be ruled out that even a measure issue in the Greek pharmacies case. of this kind may in principle constitute a restriction within the meaning of Article 28 EC. In this connection, the crucial factor is whether the form of distribution affected by the prohibition is important to the development of a mar- ket. 5 8 It is irrelevant in this connection that access by normal German public phar- 86. The Court held in Hiinermund 56that macies to the German end user market is the crucial factor is whether or not the restricted in so far as they have only a goods may be distributed by traders other restricted catchment area. than pharmacists. In the present case, in addition to the prohibition of a certain form of distribution, there is therefore also the restriction that the medicinal products may not be distributed by economic oper- ators other than pharmacists.

89. According to the judgment in Lederc- Siplec, the relevant factor is whether a national measure 'does not prevent dis- tributors from using other forms of adver- tising'. 59 87. As regards channelling to certain out- lets, however, it follows from the Court's 57 — See, in general terms, Ernst, 'Arzneimittelverkauf im Internet', Wettbewerb in Recht und Praxis, 2001, 863 (896 with further references). 55 — Case C-391/92 (cited in footnote 20). 58 — For example, Clarke (cited in footnote 39), p. 362. 56 — Case C-292/92 (cited in footnote 23), paragraph 19. 59 — Case C-412/93 (cited in footnote 24), paragraph 19.

91. If the national measure at issue does make market access virtually impossible, as 93. If the contested German rules were to is claimed by DocMorris and is not essen- be classified as a selling arrangement, the tially disputed by the other parties, this presumption made in De Agostini that the would be a restriction of free movement of rules do not fall within the scope of goods within the meaning of Article 28 EC. Article 28 EC would arise. However, that This would also be the case if it is assumed, presumption could be rebutted before the as the Court did in its judgment in De national court. Agostini, that the 'ban does not affect in the same way, in fact and in law, the marketing of national products and of products from other Member States'. 61 This is because the contested rules are capable of adversely affecting imports of medicinal products from other States by compulsorily exclud- ing an important sales channel, albeit not 94. However, if it is assumed, as is sug- the only effective channel. 62 gested here, that where market access is made appreciably more difficult, the Keck exception does not apply, i.e. there is no 60 — With regard to such a prohibition on advertising see Advocate General Jacobs in his Opinion in Joined Cases selling arrangement, it would be necessary C-34/95, C-35/95 and C-36/95 (cited in footnote 52), paragraphs 97 and 99. 61 — Judgment in Joined Cases C-34/95, C-35/95 and C-36/95 (Opinion cited in footnote 52), paragraph 44. 63 — Judgment in Joined Cases C-34/95, C-35/95 and C-36/95 62 — With regard to the sales monopoly of pharmacists see (Opinion cited in footnote 52), paragraph 43. Advocate General Lenz in his Opinion in Case C-391/92 64 — Judgment in Joined Cases C-34/95, C-35/95 and C-36/95 (judgment cited in footnote 20), paragraph 19. (Opinion cited in footnote 52), paragraph 44.

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State — to prohibit commercial import- 102. The German Government submits, in ation of medicinal products by way of mail the alternative only, given its view that order only if that Member State can sub- there is no restriction of free movement of stantiate and prove that actual dangers to goods, that the rules are justified and also health result from the pharmacy mail order proportionate on grounds of health pro- operated, authorised and supervised in the tection and do not infringe Article 28 EC. Member State of origin because of defi- If, however, that were the case, it could be ciencies in safety precautions. justified by Article 30 EC.

100. The Apothekerverband and the Aus- (ii) Assessment trian, French, German, Greek and Irish Governments take the view that the Ger- man rules are justified on grounds of protection of the health and life of humans.

— Justification for the measure 108. The proportionality test must not be based on specific individual cases, but be general. The principle of proportionality is infringed even if the infringement is merely a typical characteristic. To this end it is necessary to examine the appropriateness, 105. It is common ground that the Court's the necessity and the reasonableness of the case-law has recognised the protection of national measure. health not only in the context of Article 30 EC, but also as a mandatory requirement under Article 28 EC. 67

— Appropriateness of the national measure

111. Secondly, the necessity of the national measure must be examined with respect to health protection. 68

115. With respect to Question 1(b), it is appropriate to confine the examination to the justification based on 'protection of 112. Our starting point must be that the national authorisation rules against circum- Member States are not required to opt for vention', which was mentioned by several the lowest degree of protection. 69 parties.

113. However, the fact that such a prohib- ition is not regarded as necessary by all Member States and does not exist in all the 116. In practice there are workable meas- Member States militates against the necess- ures, i.e. measures that are effective, but are ity of the contested rules. less restrictive of free movement of goods, even though — at least according to one branch of case-law 70 — this is not in itself 68 — Case C-347/89 Eurim-Pharm [1991] ECR 1-1747, an argument for the disproportionality of paragraph 27, Case C-62/90 Commission v Germany [1992] ECR 1-2575, paragraph 12, national provisions. Case C-55/99 Commission v France [2000] ECR 1-11499, p a r a g r a p h 42 and Case C - 1 7 2 / 0 0 Ferrine [20021 ECR I-6891, paragraph 34. 69 —Joined Cases C-1/90 and C-176/90 Aragonesa and Pub- 70 —Case C-124/97 Läärä and Others [1999] ECR 1-6067, liviaa [1991] ECR 1-4151, paragraph 16. paragraph 36.

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117. As regards the danger that national their authorisation has not been recognised, authorisation rules could be circumvented that Member State may prohibit their by internet pharmacies where medicinal placing on the market. Consequently, a products that are not authorised in the prohibition on mail order that is intended importing Member State are ordered over to prevent those medicinal products being the internet and then imported into that placed on the market is also proportionate. Member State, several parties examined the state of harmonisation of the law governing authorisation of medicinal products and the importance of the judgment in Ort- scheit for the issue of authorisation.

119. The solution can in fact be found in the relevant provision of Article 3 of Directive 65/65. Under that provision, no 122. Articles 28 EC and 30 EC are to be medicinal product 'may be placed on the interpreted as meaning that national provi- market of a Member State unless a market- sions prohibiting the commercial cross- ing authorisation has been issued by the border import by mail order from auth- competent authorities of that Member State orised pharmacies in other Member States in accordance with this Directive or an of medicinal products for human use which authorisation has been granted in accord- are required to be sold through pharmacies, ance with Regulation (EEC) No 2309/93'. on the basis of individual orders placed by end users on the internet, is justified in order to protect the health and life of humans as regards medicinal products which require authorisation in the State into which they are imported, but which are neither authorised or recognised at 120. If the medicinal products have not national level, nor centrally approved at been authorised in the importing State and Community level.

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OPINION OF MRS STIX-HACKL — CASE C-322/01

B — Authorised medicinal products: 127. The Commission also takes the view Question 1(c) with regard to authorised medicinal prod- ucts that secondary Community law per- mits a prohibition on distance sales. In this connection it refers to Article 14 of Directive 97/7 and Article 1(3) and Article 3(4) of the E-commerce directive.

1. Submissions of the parties

123. DocMorris points out that the reim- portation of — authorised — medicinal products, which is recognised by the Court, 128. Furthermore, the Commission con- serves the completion of the Internal Mar- siders that the requirements laid down in ket and that there is no abuse in the present the Keck formula are also satisfied by the circumstances. prohibition on mail order in the case of authorised medicinal products.

130. In the proceedings the applicability of free movement of goods was contested on the ground that the situation in the present case, reimportation via an internet phar- macy, is an artificial commercial trans- action, which is not therefore covered by 133. Reimportation therefore takes place this fundamental freedom. It should be at a different level from exportation, pointed out in this respect that a char- namely in the relationship between the acteristic of the structure of the internet retailer (DocMorris) and the consumer, trade in medicinal products in the present who are both in a different Member State. case is that the internet pharmacy does not import the medicinal products from Ger- many itself in order to re-export them there. 71

134. The fact that the internet pharmacies also wish to develop their business in the 131. In fact, a distinction must be drawn Member States from which they obtain between two legally and economically medicinal products suggests that this struc- separate processes: the acquisition of the ture for the distribution of medicinal prod- medicinal product by the internet phar- ucts — which exists in the present case — macy from a wholesaler, where the product does not constitute abuse of free movement can be exported from Germany by the of goods. However, activity in other wholesaler, and the sale of the medicinal Member States, in particular cross-border product by the internet pharmacy to con- trade, is an essential feature of the internal sumers, e.g. in Germany. market, and of the exercise of the funda- mental freedoms. 72

136. Consideration will be given below only to those aspects that have been put forward by the parties as grounds to justify the prohibition on mail order and that are relevant for assessing the necessity and the reasonableness of the contested provisions. — Lack of expert advice?

137. In this regard, it is necessary to 139. The parties have pointed out some proceed from the principle that 'the fact benefits of advice which they believe exist that the doctor who prescribed the medici- in a normal public pharmacy, but not in the nal product or the pharmacist who sold it case of internet pharmacies. In the case of are established in a Member State other internet pharmacies, for example, they than that in which the medicinal product is allege that there is no opportunity for the used does not prevent those practitioners pharmacists to take the initiative them- from supervising the use of the imported selves to provide advice. However this medicinal product, where appropriate with possibility does also exist as a rule in the the aid of a colleague established in the case of internet pharmacies. Furthermore, it importing Member State'. 74 was not possible to demonstrate or prove with regard to normal public pharmacies with what frequency and in what circum- 73 — See Case C-201/94 Smith & Nephew and Primecrown stances information was actually provided [1996] ECR 1-5819 relating to Directive 65/65 and Case C-379/97 Upjohn [1999] ECR 1-6927 relating to trade by the pharmacist, either on the initiative of mark rights in the medicinal products sector. 74 — Case C-62/90 Commission v Germany [1992] ECR 1-2575, the patient or on the initiative of the paragraph 19. pharmacist.

75 — Case 215/87 Schumacher [1989] ECR 617, paragraph 21, concerning the lack of controls for certain types of 76 — Case 215/87 Schumacher {cited in footnote 75), paragraph imports. 20.

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dations. In certain cases, they must issue — Need to guarantee patient protection in information on their own initiative, in the delivery of medicinal products particular where there are doubts as to the content of the medicinal product. In order to prevent any misuse, the maximum quantity of the medicinal products to be dispensed could also be laid down. Labels and information must be written or appended in the language of the patient. Lastly, internet pharmacies must always be contactable. 149. The parties pointed out the need to guarantee patient protection in the delivery of medicinal products. The protection of patients in the delivery of medicinal prod- ucts can be guaranteed by appropriate measures for checks on packaging and receipt. For example, it would have to be verified that the content and quantity of the goods sent corresponded to the medicinal products ordered. In addition, proper transport must be ensured, in particular 147. In the case of prescription medicinal for heat and light-sensitive medicinal prod- products, internet pharmacies have to take ucts. Lastly, adequate checks on receipt additional measures. For example, they are must be guaranteed. These essentially in any case subject to the prescription rules include documentation of the delivery of the importing State. Furthermore, the operation, possibly by the courier, and, if medicinal products may be sent only on necessary, delivery only to the authorised presentation of an original prescription, person, which must in that event be con- which must be filed if necessary. firmed by a signature.

155. Finally, reference is made to the duty, which has also been established by the 153. It is therefore also necessary in this Court's case-law in preliminary ruling pro- respect for the Member State in question to ceedings, for a Member State that considers show that the relevant supply can be a measure restricting the movement of guaranteed only by the measure taken. goods to be justified and proportionate to However, the German Government failed show this to be the case. 78 Thus, it must to demonstrate — forecasts and fears not- show 'that the contested measure was the withstanding — that the contested provi- most appropriate means... whilst being the sions are necessary for the security of least restrictive of intra-Community supply. trade'. 79

77 — Sec Case C-158/96 Kohll [1998] ECR I-1931, paragraph 78 — Case 178/84 Commission v Germany [19871 ECR 1227, 48 et seq., Case C-368/98 Vanbraekel and Others ¡2001] paragraph 46 and Case C-158/96 (cited in footnote 77), ECR I-5363, paragraph 48, and Case C-157/99 Smits and paragraph 52. Peerbooms [2001] ECR 1-5473, paragraph 73. 79 — Case C-317/92 (cited in footnote 67), paragraph 20.

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156. The obligation to present evidence 159. Suitable measures are likely to include here concerns in particular the question first and foremost the requirements, men- whether the reliability of the internet phar- tioned in connection with each of these macy in the country of origin is guaran- objectives, relating to marketing of orders, teed, 80 in this case the State from which the shipment and transportation of packages, internet pharmacy operates. Furthermore, and receipt. the Court has expressly required it to be shown 'that the rules at issue were necess- ary to provide a balanced... service access- ible to all'. 81

1. Question 2: Prohibition on advertising medicinal products by mail order and on advertising certain medicinal products 162. The second question must also be reworded so that it is not directed expressly at the compatibility of a certain national measure:

(a) Submissions of the parties

163. In the opinion of DocMorris, the possibility of internet orders is essential for the cross-border mail order trade in medicinal products at end user level. A Are Articles 28 and 30 EC to be interpreted broad interpretation of the expression 'ad- as precluding a national prohibition on vertising to the general public' means that advertising medicinal products by mail national prohibitions based on the prohib- order, prescription medicinal products and ition laid down in Directive 92/28 restrict medicinal products available only through free movement of goods. Such measures are pharmacies that are authorised in the State not justified in order to prevent self-medi- of origin but not the importing State, under cation or to protect national authorisation which the internet presentation of a phar- schemes either. macy of an EU Member State, which in addition to presentation of its business describes individual medicinal products with their product name, prescription status, package size and price and at the same time offers the possibility of ordering those medicinal products by means of an 164. In the view of the Apothekerverband, online order form, is classified as pro- on the other hand, the prohibitions on hibited advertising, with the result that advertising, including those for authorised cross-border orders of medicinal products medicinal products, do not infringe by internet including delivery of those Articles 28 EC and 30 EC. This follows orders is at the very least made substan- from the fact that the prohibition on mail tially more difficult? order is consistent with Community law.

166. The French Government concludes (b) Assessment that, because the prohibition on mail order is lawful, the prohibition on advertising is also permitted. The prohibition on phar- macies advertising themselves does not infringe Article 28 EC either. 169. It should first be pointed out that German law on the advertising of medici- nal products draws a fundamental distinc- tion between four prohibitions on advertis- ing: concerning unauthorised medicinal products (Paragraph 3a of the HWG), 167. The Greek and Irish Governments concerning prescription medicinal products consider the prohibition on advertising (Paragraph 10 of the HWG) and concern- medicinal products by mail order and ing two prohibitions relating to mail order prescription medicinal products that are trade in medicinal products. These prohib- not authorised in the importing State to be itions are based on Paragraph 8(1)(1) of the compatible with Articles 28 EC and 30 EC. HWG, which prohibits advertising for the The Austrian Government, which refers to purchase of medicinal products that are the Community code, also considers a available only through pharmacies in gen- prohibition on advertising non-prescription eral, and Paragraph 8(2), which prohibits medicinal products that are available only advertising for individual import. through pharmacies to be justified.

170. The referring court does not refer 168. The Commission is also of the opinion expressly to any of these rules of German that the prohibitions on advertising pre- law in Question 2, but mentions three types scription and unauthorised medicinal prod- of prohibition on advertising: 'medicines by ucts are essentially selling arrangements mail order', 'prescription medicines' and I - 14932

174. The principal rule of secondary law of relevance is Directive 92/28. Article 2(1) of that directive lays down a prohibition on advertising. Since that prohibition is based on the type of medicinal product and not 171. Question 2 refers first of all to the on the form of distribution, however, its prohibition on advertising medicinal prod- scope does not coincide with that of the ucts by mail order. It is clear from the file German prohibition on advertising. Whilst submitted to the Court of Justice by the the prohibition contained in the directive referring court that, as far as medicinal applies only to medicinal products for products by mail order are concerned, the whose marketing no authorisation has been referring court considers that only the granted under Community law, prohibition laid down in Paragraph 8(1) Paragraph 8(1)(1) of the HWG prohibits of the HWG, and not the prohibition laid advertising for the purchase by mail order down in Paragraph 8(2) of the HWG, is of medicinal products that are required to applicable. The latter provision does not, be sold through pharmacies. therefore, fall within the legal or factual scope of the main proceedings.

175. The criterion for assessing a prohib- ition on advertising such as Paragraph 8(1) 172. The prohibition on advertising of the HWG under Community law there- medicinal products by mail order laid down fore remains free movement of goods. In in Paragraph 8(1) of the HWG applies only this respect it is now crucial that to medicinal products that are required to Paragraph 8(1), first, does not differentiate be sold through pharmacies, but does not according to the origin of the products and, relate to an authorisation or prescription secondly, applies to all economic operators, requirement. so that at first glance it satisfies both

179. However, the prohibition on advertis- 176. However, as has already been ing does not infringe Article 28 EC if it explained in connection with the prohib- serves a mandatory requirement and is ition on mail order, the important factor is proportionate. not just whether sales of foreign products are affected in the same manner, but whether the prohibition on advertising restricts access to the market in such a way that it is no longer a question of a mere selling arrangement. It then becomes a measure having equivalent effect within 180. In this connection, reference should be the meaning of Article 28 EC. 82 made to a judgment by the Court on a prohibition on advertising contained in the HWG. In Ortscheit the Court was required to consider the prohibition on advertising contained in Paragraph 8(2) of the HWG. Whilst those proceedings concerned only medicinal products that required authori- sation, but were not authorised in Ger- many, the statements made by the Court are so general that they can be applied to the prohibition on advertising at issue in the present case. In that judgment the 177. DocMorris observes that prohibitions Court recognised that the prohibition laid on advertising inhibit orders of medicinal down in Paragraph 8(2) of the HWG is products on the internet. DocMorris rightly necessary in order to protect national points out that internet pharmacies, unlike authorisation schemes from circumven- normal public pharmacies, have only this tion. 83 The principle must also apply to means of information at their disposal. other prohibitions on advertising medicinal products. 82 — With regard to a prohibition on advertising see also Case C-405/98 Konsumentombudsmannen [2001] ECR I-1795, paragraph 19. 83 — Case C-320/93 (cited in footnote 10), paragraph 19 et seq.

185. The prohibition on advertising laid down in Paragraph 3a of the HWG con- cerns medicinal products that have not been authorised or are not regarded as authorised either under Community pro- 182. Question 2 refers secondly to the cedures or under German law. This provi- prohibition on advertising medicinal prod- sion of German law is therefore merely the ucts that require authorisation in the national rule implementing the prohibition importing State, that is to say, Germany, under Article 2(1) of the directive. but are not authorised. The relevant Ger- man legislation is Paragraph 3a of the HWG. Whilst this rule essentially precedes Article 8(2) of the HWG, 84 the latter provision is not relevant in the main pro- ceedings, as is clear from the order for reference. 186. Consequently, since the application of Directive 92/28 takes precedence, an 84 — See, for example, Ernst (cited in footnote 57), 897; Koenig/ assessment of Paragraph 3a of the HWG Müller, 'Der werbliche Auftritt von Online-Apotheken im in the light of primary law is ruled out in Europäischen Binnenmarkt', Wettbewerb in Recht und Praxis, 2000, 1366 (1367 et seq.), according to which the present case. It is not therefore necess- Paragraph 3a is applicable where the products offered on the internet include medicinal products not authorised in ary to examine whether the national meas- Germany and contain information that can be classified as advertising for the unauthorised medicinal products ure is a selling arrangement within the (1372). meaning of the Keck formula either.

DEUTSCHER APOTHEKERVERBAND

(a) Submissions of the parties 195. In the opinion of the Apothekerver- band, Question 2(a) should be answered in the negative, because otherwise regard would not be had to the scheme and interaction of the Community rules. The E-commerce directive does not completely harmonise information society services 192. In the view of DocMorris, the and, in particular, does not cover the expression 'advertising to the general pub- conditions for the delivery of goods. The lic' within the meaning of Article 1(3) of directive is not applicable at all to mail Directive 92/28 should not be given a order trade in medicinal products which are broad interpretation, because this would only available from pharmacies. make access to the end customer market appreciably more difficult. The expression should instead be interpreted in accordance with primary law as meaning that online order forms, which contain essential infor- mation for the internet pharmacy trade, are not covered by the expression 'advertising to the general public'. 196. The German Government takes the view that advertising of medicinal products is excluded from the E-commerce directive. Before the prescribed period within which the directive must be transposed has expired, an interpretation by the national court in accordance with the directive is also ruled out. 193. In the view of DocMorris, the pro- hibitions on advertising in Paragraph 3a, Paragraph 8(1) and (2) and Paragraph 10 therefore infringe Article 28 EC.

197. Article 1(3) and the 11th recital of the E-commerce directive are without prejudice to the level of protection for public health.

200. The Irish Government interprets (b) Assessment Articles 28 EC and 30 EC as meaning that they do not exclude the internet presenta- tion at issue from the scope of the expression 'advertising to the general pub- lic'. 203. Unlike Question 2, Question 2(a) concerns the prohibition of advertising to the general public of certain medicinal products under Article 3(1) of Directive 92/28. This prohibition is based on the expression 'advertising to the general pub- 201. The Austrian Government bases its lic' which, under Article 1(3) of submissions on the Community code. Directive 92/28, falls within the scope of Under Article 86 of the Community code, the term 'advertising'. order lists for medicinal products are to be classified as advertising. It follows from Article 88(1) of the Community code that Member States are required to prohibit advertising for prescription medicinal prod- ucts. Article 88(2) provides for an excep- tion for certain medicinal products. The 204. The expression 'advertising of medici- E-commerce directive does not preclude the nal products' is defined in Article 1(3) of prohibition on advertising either. Under Directive 92/28 as 'any form of door-to- that directive, Member States may prohibit door information, canvassing activity or not only mail order trade in medicinal inducement designed to promote the pre- products itself, but also advertising for scription, supply, sale or consumption of those products. medicinal products'. I - 14938

DEUTSCHER APOTHEKERVERBAND

205. On the other hand, Directive 92/28 the general public and advertising for does not provide for a legal definition of specialists. This distinction in the target the expression 'advertising of medicinal group alone does not justify any reduction products to the general public'. The starting of the expression. Nevertheless, because the point for interpreting that expression there- general public, i.e. lay people, merit greater fore remains 'advertising' as a generic term, protection, special importance is attached which also encompasses 'advertising of to the prohibition on advertising. medicinal products to the general public' under Article 1(3), first indent.

209. However, the broad definition of 'advertising to the general public' must in any case be narrowed so as not to include general information on an internet phar- macy, i.e. image-based and corporate advertising. The essence of advertising to 207. On the basis of the deliberately broad the general public is product advertising. formulation of the term 'advertising' 85 in Directive 92/28, a broad interpretation will also have to be given to the expression 'advertising to the general public'. This view is supported by the fact that a fundamental distinction is drawn in prac- tice in advertising for medicinal products in the Member States between advertising for 210. The information which DocMorris considers to be essential, such as product 85 — With regard to the broad interpretation of the term name, contents, prescription status, pack- 'advertising', see the judgment in Case C-112/99 Toshiba Europe [2001] ECR I-7945, paragraph 28, con- age size and price, indicate that product cerning misleading advertising. advertising is at issue in the present case.

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211. The assessment is based essentially on 214. An interpretation in the light of the objective impression given to con- higher-ranking primary law does not pro- sumers by the overall appearance of the duce any different conclusion. Free move- website. 86 An important indicator is the ment of goods does not have sufficiently fact that DocMorris divides its product specific substance to be able to derive from range into different headings, under which it a reduction of the broad notion of each of the individual medicinal products 'advertising to the general public'. are shown. These may be ordered by clicking on a box. The range can therefore be specified by product through operations by the internet user. According to a dif- ferent view, the naming of medicinal prod- ucts alone is sufficient for the presumption to arise that an internet presentation has an advertising effect. 87

217. As a result, the fundamental question 220. Article 2(1) of Directive 92/28 is to be of the relationship between the E-com- interpreted as not precluding a national merce directive and Directive 92/28 does prohibition on the advertising of medicinal not have to be examined here. Because the products for human use that are required to E-commerce directive does not apply, it is be sold in pharmacies which are not auth- not necessary either to examine the import- orised in the importing State, but are ance of the country of origin principle laid authorised in the State of origin. down therein, the possibility that exists under Article 3(4) of the E-commerce directive to derogate for reasons of public health or the scope of the exception on grounds of protection of public health under Article 1(3) of the E-commerce directive. 221. The expression 'advertising to the general public' in Article 1(3) of Directive 92/28 is to be interpreted as including an internet presentation by a pharmacy in a Member State which describes the individ- ual medicinal products with their product name, prescription status, package size and price, and at the same time offers the 3. Interim conclusion possibility of ordering those medicinal products using an online order form.

218. Articles 28 EC and 30 EC are to be interpreted as precluding a national pro- hibition on advertising medicinal products by mail order — other than the advertising of medicinal products for human use — unless the prohibition serves to protect B — Question 2(b): Parts of the internet national authorisation rules and is propor- presentation as trade catalogue and/or price tionate. list?

224. The Apothekerverband suggests that, on the grounds put forward in connection 2. Assessment with Question 2(a), Question 2(b) should be answered in the negative. The E-com- merce directive should not be given preced- ence in the interpretation of Directive 92/28 228. First of all, it must be assumed that in this instance either. Article 1(4) of Directive 92/28 lays down I - 14942

DEUTSCHER APOTHEKER VERB AND

an exception from the scope of the direc- 231. Furthermore, as the Commission tive — and therefore from the prohibition observes, it should be pointed out that the on advertising — and for that very reason internet presentation of a pharmacy serves must be given a restrictive interpretation. to pave the way for business contacts.

232. With regard to the argument made by DocMorris that an online order form is necessary for the mail order trade in medicinal products it must be contended that Article 1(4) of Directive 92/28 makes no reference to necessity. 229. It should also be pointed out that the exception at issue, which is laid down in the third indent of Article 1(4) of Directive 92/28, does not contain an illus- trative list, but mentions only trade cata- logues and price lists. However, this provi- sion does not refer to order forms of any 233. However, a definitive classification of kind, let alone online forms. online order forms as trade catalogues or price lists is not necessary for a different reason. Even if online order forms were to be classified as trade catalogues or price lists, that fact alone would not mean that the directive was not applicable.

236. However, it is not for the Court of Justice but for the national court to deter- mine which information is actually included in the internet presentation of DocMorris, in particular whether it also includes claims about medicinal products. 1. Submissions of the parties

239. With regard to freedom to provide services, the Apothekerverband and the German Government stated in the oral procedure that this fundamental freedom does not apply in the present case. 3. Interim conclusion

240. The Greek Government treats the sale of medicinal products over the internet in 237. The answer to Question 2(b) should the same way as teleshopping, which is therefore be that online order forms con- prohibited under Article 15 of the Televi- taining information about medicinal prod- sion directive. 89 ucts are not to be regarded as trade catalogues and/or price lists within the meaning of Article 1(4) of Directive 92/28. 89 — Council Directive 89/552/EEC (cited in footnote 13).

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241. The Commission has already pointed 244. A distinction can be drawn between out in its written observation that, with its the contested prohibitions on advertising internet presentation, DocMorris also laid down in the HWG in so far as wishes to reach customers in German- Paragraph 8 concerns the mail order trade speaking Member States. The German in medicinal products, whilst the prohib- prohibitions on advertising are to be clas- itions on advertising in Paragraph 3a and sified as restrictions on the movement of Paragraph 10 apply to certain types of services. However, these restrictions might medicinal products. be justified on grounds of health protec- tion.

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products itself arranges for its products to the dealer's economic activity with the be advertised, within the limits of Commu- advertised product, 92 for example a phar- nity law. macist. This is because in De Agostini the Court had concentrated, as far as freedom to provide services was concerned, on the service provided by the undertaking that wished to carry on the advertising activity and the related national restriction, and not on the undertaking whose goods or services were to be advertised.

248. The mail order trade in medicinal products cannot be classified here as an economic activity to be assessed separately. It is merely a certain form of purchase, i.e. 250. Since the referring court did not refer delivery of goods. This does not therefore to freedom to provide services in any of its constitute an autonomous service. Whilst questions, it is not surprising that it has not the market in advertising is economically passed on any relevant information to the and legally distinct from the market in Court. However, it is not possible to infer goods, a separate assessment of economic adequate information from the other transactions in the main proceedings would papers in order to be able to assess the be highly artificial. 90 contested prohibitions on advertising in the light of freedom to provide services.

251. Consequently, in my opinion, the Court cannot comment on the interpre- 249. The main proceedings therefore differ tation of freedom to provide services in the considerably from the proceedings where present case. the Court had decided cases concerning television or cable advertising. 91 In par- ticular, the judgment in De Agostini, to which the Commission makes reference, is of no relevance as regards restrictions of

2. Assessment 1. Submissions of the parties

257. The third question also concerns the 253. DocMorris considers that cross- interpretation of Articles 28 EC and border mail order trade in medicinal prod- 30 EC — as with the first question — in ucts must be guaranteed. This must be the relation to the trade in medicinal products. case even if subsidiary aspects of an inter- Essentially, it seeks to ascertain whether a net presentation infringe rules on advertis- prohibition on advertising has implications ing of medicinal products. for the assessment of whether the trade in medicinal products is permissible.

254. In the view of the Apothekerverband, cross-border movement of goods, that is to say, mail order trade in medicinal products, 258. In this connection it should be stressed cannot be implemented 'at any price'. A that trade and advertising are economically modification can be brought about if related, but must be treated separately from necessary by a revision of Community law. a legal point of view. I - 14947

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259. In the present case, this is indicated 260. With regard to the interpretation of simply by the questions referred for a Articles 28 EC and 30 EC in relation to preliminary ruling, the first of which relates trade in medicinal products, reference can to the trade in medicinal products, the therefore only be made at this juncture to second to advertising for mail order, that is the answer to the first question. to say, trade, and to advertising for certain medicinal products.

V I I I— Conclusion

Articles 28 EC and 30 EC are to be interpreted as meaning that a national prohibition on the import of medicinal products that are authorised in the importing State, which a pharmacy in another Member State previously obtained from wholesalers in the importing State, is not justified in order to protect the health and life of humans, in so far as attainment of the objectives pursued by the importing State is guaranteed by other means.

2. Articles 28 EC and 30 EC are to be interpreted as precluding a national prohibition on advertising medicinal products by mail order — other than the advertising of medicinal products for human use — unless the prohib- ition serves to protect national authorisation rules and is proportionate.

Article 3(1) of Council Directive 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use is to be interpreted as not precluding a national prohibition on the advertising of prescription medicinal products for human use. I - 14949

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Article 2(1) of Directive 92/28/EEC is to be interpreted as not precluding a national prohibition on the advertising of medicinal products for human use that are required to be sold in pharmacies which are not authorised in the importing State, but are authorised in the State of origin.

The expression 'advertising to the general public' in Article 1(3) of Directive 92/28/EEC is to be interpreted as including an internet presentation by a pharmacy in a Member State which describes the individual medicinal products with their product name, prescription status, package size and price, and at the same time offers the possibility of ordering those medicinal products using an online order form.