Deutscher Apothekerverband eV v 0800 DocMorris NV and Jacques Waterval.
Date: 2003-12-11
48.  If a provision such as Paragraph 73(1) of the AMG is compatible with Community law, it will not be necessary to consider whether, in respect of this category of medicines, Articles 28 EC to 30 EC preclude national legislation which prohibits the sale by mail order of medicinal products the sale of which is restricted to pharmacies.
Observations submitted to the Court
52.  As the German and Greek Governments and the Commission rightly observe, the general prohibition imposed by Paragraph 73(1) of the AMG corresponds to the prohibition, at Community level, on placing on the market medicinal products which have not been authorised in the Member State concerned, which was laid down in Article 3 of Directive 65/65, now replaced by Article 6(1) of the Community Code.  According to those provisions, medicinal products, even if they are authorised in one Member State, must also, if they are to be placed on the market of another Member State, have been authorised either by the competent authority of that State or under the Community rules referred to in those provisions.
53.  Consequently, a national rule such as Paragraph 73(1) of the AMG, whereby a Member State discharges its obligations under Directive 65/65 and the Community Code, cannot be characterised as a measure having equivalent effect to a quantitative restriction on imports within the meaning of Article 28 EC (see, to that effect, in the context of Council Directive 86/469/EEC of 16 September 1986 concerning the examination of animals and fresh meat for the presence of residues (OJ 1986 L 275, p. 36), Case C-246/98   Berendse-Koenen   [2000] ECR I-1777, paragraph 25).  Accordingly, Articles 28 EC to 30 EC cannot be relied on in order to circumvent the system of national authorisation provided for by Directive 65/65 and the Community Code, which is implemented in national law by Paragraph 73(1) of the AMG.
54.  It follows from that finding that, as regards medicinal products which are subject to, but which have not obtained, authorisation there is no need to consider whether the national provisions at issue in the main proceedings are precluded by Articles 28 EC to 30 EC.
Medicinal products which are authorised in Germany
64.  A national measure in a sphere which has been the subject of exhaustive harmonisation at Community level must be assessed in the light of the provisions of the harmonising measure and not those of the Treaty (see Case C-37/92   Vanacker and Lesage   [1993] ECR I-4947, paragraph 9, and Case C-324/99   DaimlerChrysler   [2001] ECR I-9897, paragraph 32).  However, the power conferred on Member States by Article 14(1) of Directive 97/7 must be exercised with due regard for the Treaty, as is expressly stated in that provision.
65.  Such a provision does not, therefore, obviate the need to ascertain whether the national prohibition at issue in the main proceedings is compatible with Articles 28 EC to 30 EC.
66.  In that regard, there is settled case-law to the effect that all measures which are capable of hindering directly or indirectly, actually or potentially, intra-Community trade are to be regarded as measures having equivalent effect to quantitative restrictions and, on that basis, as prohibited by Article 28 EC (see Case 8/74   Dassonville   [1974] ECR 837, paragraph 5, and Case C-420/01   Commission   v   Italy   [2003] ECR I-6445, paragraph 25).
67.  Even if a measure is not intended to regulate trade in goods between Member States, the determining factor is its effect, actual or potential, on intra-Community trade.  By virtue of that factor, in the absence of harmonisation of legislation, obstacles to the free movement of goods which are the consequence of applying, to goods coming from other Member States where they are lawfully manufactured and marketed, rules that lay down requirements to be met by such goods constitute measures of equivalent effect prohibited by Article 28 EC, even if those rules apply to all products alike, unless their application can be justified by a public-interest objective taking precedence over the requirements of the free movement of goods (Case 120/78   Rewe-Zentral   (Cassis de Dijon  ) [1979] ECR 649, paragraphs 6, 14 and 15;   Keck and Mithouard  , paragraph 15, and   Familiapress  , paragraph 8).
68.  Furthermore, as the Court held in   Keck and Mithouard  , even if commercial rules do not relate to the actual characteristics of the products but govern the arrangements for their sale, they may constitute measures of equivalent effect for the purposes of Article 28 EC if they fail to meet two conditions.  Those conditions are that such rules must apply to all relevant traders operating in national territory and must affect in the same manner, in law and in fact, the marketing of both domestic products and those from other Member States (see   Keck and Mithouard  , paragraph 15;   Hünermund  , paragraph 21, and Case C-412/93   Lerclerc-Siplec   [1995] ECR I-179, paragraph 21).
71.  In order to ascertain whether a particular measure affects in the same manner the   "marketing"   of both domestic products and those from other Member States, the scope of the restrictive measure concerned must be ascertained.  Thus, the Court has found that a prohibition on pharmacists from advertising quasi-pharmaceutical products outside the pharmacy, which they were authorised to offer for sale, did not affect the ability of traders other than pharmacists to advertise those products (see   Hünermund  , paragraph 19).  Similarly, the prohibition on broadcasting the advertising at issue in   Leclerc-Siplec   was not extensive, since it covered only one particular form of promotion (television advertising) of one particular method of marketing products (distribution) (see   Leclerc-Siplec  , paragraph 22).
72.  By contrast, the Court has accepted the relevance of the argument that a prohibition on television advertising deprived a trader of the only effective form of promotion which would have enabled it to penetrate a national market (see   De Agostini and TV-Shop  , paragraph 43).  Furthermore, the Court has found that in the case of products such as alcoholic beverages, the consumption of which is linked to traditional social practices and to local habits and customs, prohibiting all advertising directed at consumers in the form of advertisements in the press, on the radio and on television, the direct mailing of unsolicited material or the placing of posters on the public highway is liable to impede access to the market for products from other Member States more than it impedes access for domestic products, with which consumers are instantly more familiar (see Case C-405/98   Gourmet International Products   [2001] ECR I-1795, paragraphs 21 and 24).
74.  A prohibition such as that at issue in the main proceedings is more of an obstacle to pharmacies outside Germany than to those within it.  Although there is little doubt that as a result of the prohibition, pharmacies in Germany cannot use the extra or alternative method of gaining access to the German market consisting of end consumers of medicinal products, they are still able to sell the products in their dispensaries.  However, for pharmacies not established in Germany, the internet provides a more significant way to gain direct access to the German market.  A prohibition which has a greater impact on pharmacies established outside German territory could impede access to the market for products from other Member States more than it impedes access for domestic products.
75.  Accordingly, the prohibition does not affect the sale of domestic medicines in the same way as it affects the sale of those coming from other Member States.
76.  The answer to Question 1(a) is therefore that a national prohibition on the sale by mail order of medicinal products the sale of which is restricted to pharmacies in the Member State concerned, such as the prohibition laid down in Paragraph 43(1) of the AMG, is a measure having an effect equivalent to a quantitative restriction for the purposes of Article 28 EC.
Whether there is any justification for the prohibition on mail-order sales (Question 1(b))
102.  As is maintained by the parties to the main action, the Member States which have submitted observations to the Court and the Commission, Article 30 EC continues to apply in relation to the manufacture and marketing of specialised pharmaceutical products as long as harmonisation of national rules has not been fully achieved in those areas (see   Schumacher  , paragraph 15;   Delattre  , paragraph 48;   Eurim-Pharm  , paragraph 26;   Commission   v   Germany  , paragraph 10; and   Ortscheit  , paragraph 14). In that regard, it should be noted that the sale of medicinal products to end consumers has not been subject to full Community harmonisation.
103.  It is settled case-law that the health and life of humans rank foremost among the assets or interests protected by Article 30 EC and it is for the Member States, within the limits imposed by the Treaty, to decide what degree of protection they wish to assure (see   Schumacher  , paragraph 17;   Eurim-Pharm  , paragraph 26; and   Ortscheit  , paragraph 16).
104.  However, national rules or practices likely to have a restrictive effect, or having such an effect, on the importation of pharmaceutical products are compatible with the Treaty only to the extent that they are necessary for the effective protection of health and life of humans.  A national rule or practice cannot benefit from the derogation provided for in Article 30 EC if the health and life of humans may be protected just as effectively by measures which are less restrictive of intra-Community trade (Schumacher  , paragraphs 17 and 18;   Delattre  , paragraph 53;   Eurim-Pharm  , paragraph 27;   Commission   v   Germany  , paragraphs 10 and 11; and   Ortscheit  , paragraph 17).
106.  The only arguments which are capable of providing adequate reasons for  prohibiting the mail-order trade in medicinal products are those relating to the need to provide individual advice to the customer and to ensure his protection when he is supplied with medicines and to the need to check that prescriptions are genuine and to guarantee that medicinal products are widely available and sufficient to meet requirements.
107.  Looked at generally, most of those reasons are based on the possible dangers posed by medicinal products and, accordingly, on the care which must be taken with all aspects of the marketing of those products, objectives which are also those of the Community legislation in the pharmaceuticals field.  Thus, and in any event, consideration of the reasons put forward to justify the prohibition on the sale by mail order of medicinal products must take into account the various provisions of Community law which may affect that issue.
109.  Second, the distinction between medicinal products which are subject to prescription and those which are not, which is based on those criteria and which thus concerns the potential danger of the product concerned, is applied in the Community rules concerning advertising for medicinal products.  As pointed out in paragraphs 7 to 13 of this judgment, advertising of prescription medicines is prohibited (Article 88(1) of the Community Code), whilst, in general, advertising of medicinal products intended and designed for use without the intervention of a medical practitioner is permitted, provided that certain conditions are complied with (see Article 88(2) of the Community Code).
112.  None of the reasons which the Apothekerverband advances by way of justification can provide a valid basis for the absolute prohibition on the sale by mail order of non-prescription medicines.
113.  First, as regards the need to provide the customer with advice and information when a medicinal product is purchased, it is not impossible that adequate advice and information may be provided.  Furthermore, as the defendants in the main proceedings point out, internet buying may have certain advantages, such as the ability to place the order from home or the office, without the need to go out, and to have time to think about the questions to ask the pharmacists, and these advantages must be taken into account.
114.  As to the argument that   "virtual pharmacists"   are less able to react than pharmacists in dispensaries, the disadvantages which have been mentioned in this regard concern, first, the fact that the medicine concerned may be incorrectly used and, second, the possibility that it may be abused.  As regards incorrect use of the medicine, the risk thereof can be reduced through an increase in the number of on-line interactive features, which the customer must use before being able to proceed to a purchase.  As regards possible abuse, it is not apparent that for persons who wish to acquire non-prescription medicines unlawfully, purchase in a traditional pharmacy is more difficult than an internet purchase.
117.  The supply to the general public of prescription medicines needs to be more strictly controlled.  Such control could be justified in view of, first, the greater risks which those medicines may present (see Article 71(1) of the Community Code) and, second, the system of fixed prices which applies to them and which forms part of the German health system.
122.  Although aims of a purely economic nature cannot justify restricting the fundamental freedom to provide services, it is not impossible that the risk of seriously undermining the financial balance of the social security system may constitute an overriding general-interest reason capable of justifying a restriction of that kind (see   Kohll  , paragraph 41;   Vanbraekel  , paragraph 47;   Smits and Peerbooms  , paragraph 72; and Case C-358/99   Müller-Fauré and Van Riet   [2003] ECR I-4509, paragraphs 72 and 73).  Moreover, a national market for prescription medicines could be characterised by non-commercial factors, with the result that national legislation fixing the prices at which certain medicinal products are sold should, in so far as it forms an integral part of the national health system, be maintained.
124.  In the light of the foregoing, the answer to Question 1(b) must be that Article 30 EC may be relied on to justify a national prohibition on the sale by mail order of medicinal products the sale of which is restricted to pharmacies in the Member State concerned in so far as the prohibition covers medicinal products subject to prescription.  However, Article 30 EC cannot be relied on to justify an absolute prohibition on the sale by mail order of medicinal products which are not subject to prescription in the Member State concerned.
Reimportation of medicinal products (Question 1(c))
127.  The place of manufacture of a product is of no significance as regards the question whether Paragraph 43(1) of the AMG is a measure having an effect equivalent to a quantitative restriction for the purposes of Article 28 EC.  Accordingly, a product manufactured in the territory of a Member State which is then exported and reimported into the first Member State constitutes an imported product in the same way as a product manufactured in another Member State which is then directly introduced into the national territory (see, to that effect,   Leclerc  , paragraph 26, and   Schmit  , paragraph 10).
144.  It follows that Article 88(2) of the Community Code, which allows medicinal products not subject to prescription to be advertised to the general public, cannot be interpreted as precluding advertising for the sale by mail order of medicines on the basis of the alleged need for a pharmacist to be physically present. Accordingly, Article 88(1) of the Community Code, which prohibits advertising for prescription medicines, precludes a prohibition such as that laid down in Paragraph 8(1) of the HWG in so far as that prohibition covers non-prescription medicines.
Scope of the concept of   "advertising to the general public"   under Article 1(3), first indent, and Article 3(1) of Directive 92/28