1 This request for a preliminary ruling concerns the interpretation of Article 86(1) and Article 87(3) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive 2011/62/EU of the European Parliament and of the Council of 8 June 2011 (OJ 2011 L 174, p. 74) (‘Directive 2001/83’).
2 The request has been made in proceedings between Apothekerkammer Nordrhein (Professional Association of Pharmacists of the North Rhine region, Germany) and DocMorris NV, a company incorporated under Netherlands law operating a mail-order pharmacy established in the Netherlands, concerning a claim for damages brought by that company based on the fact that the Professional Association of Pharmacists of the North Rhine region obtained from a German court interim cessation measures that it claims were unjustified from the moment they were granted.
3 Recitals 2, 45 and 50 of Directive 2001/83 state: ‘(2) The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health. … (45) Advertising to the general public, even of non-prescription medicinal products, could affect public health, were it to be excessive and ill-considered. Advertising of medicinal products to the general public, where it is permitted, ought therefore to satisfy certain essential criteria which ought to be defined. … (50) Persons qualified to prescribe medicinal products must be able to carry out these functions objectively without being influenced by direct or indirect financial inducements.’
4 Article 85c(1) of that directive is worded as follows: ‘Without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of information society services, Member States shall ensure that medicinal products are offered for sale at a distance to the public by means of information society services as defined in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services [(OJ 1998 L 204, p. 37)] under the following conditions: …’
5 Article 86(1) of that directive provides: ‘For the purposes of this Title, “advertising of medicinal products” shall include any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products; it shall include in particular: - the advertising of medicinal products to the general public, - …’
6 Article 87(3) of the directive provides: ‘The advertising of a medicinal product: - shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties, - shall not be misleading.’
7 According to Article 88(1) and (2) of Directive 2001/83: ‘1. Member States shall prohibit the advertising to the general public of medicinal products which: (a) are available on medical prescription only, in accordance with Title VI; … 2. Medicinal products may be advertised to the general public which, by virtue of their composition and purpose, are intended and designed for use without the intervention of a medical practitioner for diagnostic purposes or for the prescription or monitoring of treatment, with the advice of the pharmacist, if necessary.’
8 Article 1(1) and (2) of Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (‘Directive on electronic commerce’) (OJ 2000 L 178, p. 1), is worded as follows: ‘1. This Directive seeks to contribute to the proper functioning of the internal market by ensuring the free movement of information society services between the Member States. 2. This Directive approximates, to the extent necessary for the achievement of the objective set out in paragraph 1, certain national provisions on information society services relating to the internal market, the establishment of service providers, commercial communications, electronic contracts, the liability of intermediaries, codes of conduct, out-of-court dispute settlements, court actions and cooperation between Member States.’
9 Article 2(h) of that directive provides: ‘For the purposes of this Directive, the following terms shall bear the following meanings: … (h) “coordinated field”: requirements laid down in Member States’ legal systems applicable to information society service providers or information society services, regardless of whether they are of a general nature or specifically designed for them. (i) The coordinated field concerns requirements with which the service provider has to comply in respect of: - the taking up of the activity of an information society service, such as requirements concerning qualifications, authorisation or notification, - the pursuit of the activity of an information society service, such as requirements concerning the behaviour of the service provider, requirements regarding the quality or content of the service including those applicable to advertising and contracts, or requirements concerning the liability of the service provider; (ii) The coordinated field does not cover requirements such as: - requirements applicable to goods as such, - requirements applicable to the delivery of goods, - requirements applicable to services not provided by electronic means.’
10 Article 3(2) and (4) of that directive provides: ‘2. Member States may not, for reasons falling within the coordinated field, restrict the freedom to provide information society services from another Member State. … 4. Member States may take measures to derogate from paragraph 2 in respect of a given information society service if the following conditions are fulfilled: (a) the measures shall be: (i) necessary for one of the following reasons: - public policy, in particular the prevention, investigation, detection and prosecution of criminal offences, including the protection of minors and the fight against any incitement to hatred on grounds of race, sex, religion or nationality, and violations of human dignity concerning individual persons, - the protection of public health, - public security, including the safeguarding of national security and defence, - the protection of consumers, including investors; (ii) taken against a given information society service which prejudices the objectives referred to in point (i) or which presents a serious and grave risk of prejudice to those objectives; (iii) proportionate to those objectives; (b) before taking the measures in question and without prejudice to court proceedings, including preliminary proceedings and acts carried out in the framework of a criminal investigation, the Member State has: - asked the Member State referred to in paragraph 1 to take measures and the latter did not take such measures, or they were inadequate, - notified the [European] Commission and the Member State referred to in paragraph 1 of its intention to take such measures.’
11 The first sentence of Paragraph 7(1) of the Gesetz über die Werbung auf dem Gebiete des Heilwesens (Heilmittelwerbegesetz) (Law on the advertising of medicinal products), in the version applicable to the main proceedings (‘the HWG’), provides: ‘It shall be prohibited to offer, announce or grant monetary advantages and other promotional gifts (goods or services) or accept them as a healthcare professional, unless: (1) those monetary advantages or promotional gifts are of minor objects of low value … Monetary advantages and other promotional gifts in respect of medicinal products are prohibited if they are granted in breach of the pricing rules applicable under the [Arzneimittelgesetz (Law on medicinal products)]. (2) those monetary advantages and promotional gifts: (a) are granted as a specific sum of money or as a sum of money to be calculated in a specific way … … The monetary advantages and promotional gifts in respect of medicinal products provided for in subparagraph (a) shall be prohibited if they are granted in breach of the pricing provisions applicable on the basis of the Law on medicinal products. … …’
12 DocMorris operates a mail-order pharmacy established in the Netherlands that supplies prescription and non-prescription medicines to customers in Germany.
13 Since 2012, it has run various advertising campaigns to promote the purchase of prescription-only medicinal products forming part of its entire product range.
14 Taking the view that those advertising campaigns infringed the fixed-price system that applies to prescription-only medicinal products under the German legislation on medicinal products, the Professional Association of Pharmacists of the North Rhine region obtained, in the years 2013 to 2015, provisional measures for the cessation of those advertising campaigns, which were issued in the context of interim measures by means of orders by the Landgericht Köln (Regional Court, Cologne, Germany).
15 In the first place, on 8 May 2013, the Landgericht Köln (Regional Court, Cologne) adopted an order granting interim measures against an advertising campaign that offered DocMorris’ customers, in return for sending in their medical prescription and participating in a medication check, a reward of between EUR 2.50 and EUR 20 per prescription.
16 In the second place, on 26 September 2013, that court made an order granting interim measures against an advertising campaign that provided for a referral scheme. When a friend of a DocMorris customer sent a medical prescription, that customer obtained a voucher worth approximately EUR 150 for a stay in a hotel, or an offer to join the Allgemeiner Deutscher Automobil-Club (German automobile club) at a reduced price. The friend also received a EUR 5 voucher that could be used to order non-prescription medicines or health and care products.
17 In the third place, on 5 November 2013, that court adopted an order granting interim measures against an advertising campaign offering an immediate reduction of EUR 10 when a medical prescription was sent in.
18 In the fourth place, on 4 November 2014, that court adopted an order granting interim measures against an advertising campaign that offered DocMorris’ customers, in return for sending in a medical prescription, a EUR 10 voucher to be used for the subsequent purchase of non-prescription medicinal products or health and care products.
19 In the fifth and last place, on 29 September 2015, the Landgericht Köln (Regional Court, Cologne) issued an order granting interim measures against an advertising campaign that offered customers, in return for sending in a medical prescription, a discount of EUR 5 that was directly deducted from the amount of the invoice for the prescribed medicinal products.
20 Following the judgment of the Court of 19 October 2016, Deutsche Parkinson Vereinigung (C‑148/15, EU:C:2016:776), the Landgericht Köln (Regional Court, Cologne), by judgments of 21 and 22 March 2017, decided to set aside four of those five orders, the order of 26 September 2013 concerning the referral scheme being the one that remained valid.
21 After those four orders were set aside, DocMorris brought an action for damages against the Professional Association of Pharmacists of the North Rhine region, on the ground that the interim measures, in the context of which high fines had been imposed on it, were unjustified from the outset.
22 The court of first instance, the Landgericht Düsseldorf (Regional Court, Düsseldorf, Germany), dismissed that action.
23 However, hearing the case on appeal, the Oberlandesgericht Düsseldorf (Higher Regional Court, Düsseldorf, Germany), by a partial judgment on the merits, varied the judgment of the Landgericht Düsseldorf (Regional Court, Düsseldorf), upheld DocMorris’ claim for damages amounting to approximately EUR 18.5 million as well as, in essence, DocMorris’ application seeking a declaration of additional harm resulting from the enforcement of the interim measures, and granted leave to bring an action for judicial review of its own judgment.
24 Accordingly, the Professional Association of Pharmacists of the North Rhine region brought an action for judicial review before the Bundesgerichtshof (Federal Court of Justice, Germany), the referring court, in which it maintains its claim that the application for damages should be dismissed in its entirety.
25 The referring court notes that only two of the advertising campaigns at issue in the dispute before it, namely those which were the subject of the orders of 5 November 2013 and 29 September 2015, come within the scope of letter (a) of the first clause of point 2 of the second half of the first sentence of Article 7(1) of the HWG and are therefore lawful, since they concerned advertising benefits or gifts in the form of a specific sum of money or a sum of money to be calculated in a specific way. By contrast, it considers that the advertising campaigns which were the subject of the orders of 8 May 2013, 26 September 2013 and 4 November 2014 do not come within the scope of that provision of the HWG and are, accordingly, unlawful.
26 In order to ensure that the relevant provisions of the HWG are interpreted in conformity with Directive 2001/83, the referring court asks whether the advertising campaigns at issue in the dispute before it, which concern the purchase of prescription-only medicinal products, forming part of a pharmacy’s entire range of products, come within the scope of that directive. With reference in particular to the judgments of the Court of Justice of 1 October 2020, A (Advertising and sale of medicinal products online) (C‑649/18, EU:C:2020:764), of 15 July 2021, DocMorris (C‑190/20, EU:C:2021:609), and of 22 December 2022, EUROAPTIEKA (C‑530/20, EU:C:2022:1014), the referring court asks whether those advertising campaigns come within the concept of ‘advertising of medicinal products’ within the meaning of Article 86(1) of that directive or whether, on the contrary, they are intended solely to influence the choice of pharmacy from which a customer purchases a prescription-only medicinal product, that choice falling outside the scope of that directive.
27 In the event that Directive 2001/83 is applicable, the referring court also asks whether that directive precludes an interpretation of the relevant provisions of the HWG to the effect that advertising measures promoting the purchase of prescription-only medicinal products through promotional gifts in the form of vouchers for the subsequent purchase of other products are prohibited, whereas advertising measures in the form of price reductions and payments with immediate effect are permitted.
28 According to the referring court, promotional gifts in the form of vouchers create a risk of undue influence on the customer of the pharmacy concerned, since such advertising measures tend to encourage the subsequent purchase of other products. That risk would undermine the objective of protection pursued by the relevant provisions of the HWG, which is to combat non-critical self-medication, overconsumption and misuse of therapeutic products, which may be dangerous to health.
29 By contrast, as is apparent from paragraph 25 above, advertising measures that offer promotional gifts in the form of price reductions and payments with immediate effect are authorised by the relevant provisions of the HWG. However, the referring court is uncertain whether the authorisation of such advertising measures is compatible with Directive 2001/83.
30 In those circumstances, the Bundesgerichthof (Federal Court of Justice) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling: ‘(1) Does advertising for the purchase of prescription medicinal products from the entire range of products of a pharmacy fall within the scope of the rules on the advertising of medicinal products in Directive 2001/83 (Titles VIII and VIIIa, Articles 86 to 100)? (2) If Question 1 is to be answered in the affirmative: Is it consistent with the provisions of Title VIII of Directive 2001/83, in particular Article 87(3), if a national rule (here: letter (a) of the first clause of point 2 of the second half of the first sentence of Paragraph 7(1) of the HWG) is interpreted as prohibiting the advertising of the entire range of prescription medicinal products of a mail-order pharmacy established in another Member State using promotional gifts in the form of vouchers for a monetary amount or a percentage discount for subsequent purchases of other products? (3) If Question 1 is to be answered in the affirmative: Is it consistent with the provisions of Title VIII of Directive 2001/83, in particular Article 87(3), if a national rule (here: letter (a) of the first clause of point 2 of the second half of the first sentence of Paragraph 7(1) of the HWG) is interpreted as permitting the advertising of the entire range of prescription medicinal products of a mail-order pharmacy established in another Member State using promotional gifts in the form of immediately effective price reductions and payments?’
31 By its first question, the referring court asks, in essence, whether Article 86(1) of Directive 2001/83 must be interpreted as meaning that advertising measures promoting the purchase of prescription-only medicinal products from a pharmacy’s entire product range come within the concept of ‘advertising of medicinal products’ within the meaning of that provision.
32 Article 86(1) of Directive 2001/83 defines the concept of ‘advertising of medicinal products’ very broadly as including ‘any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products’, including, in particular, ‘the advertising of medicinal products to the general public’, which is not expressly excluded by Article 86(2) of Directive 2001/83 (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 32).
33 Since that provision does not make any reference to national laws, that concept must be regarded as an autonomous concept of EU law, which must be interpreted in a uniform manner throughout the territory of the European Union taking into consideration not only the wording of that provision, but also the context in which it occurs and the objectives pursued by the rules of which it is part (judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 31).
34 In that regard, the Court has already held that it follows from a literal, contextual and teleological interpretation of Article 86(1) of Directive 2001/83 that the concept of ‘advertising of medicinal products’, within the meaning of that provision, covers any form of soliciting referred to in paragraph 32 above both in respect of a specific medicinal product and unspecified medicinal products (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 47).
35 Moreover, it is clear from the wording of Article 86(1) of Directive 2001/83 that the purpose of the message constitutes the fundamental defining characteristic of ‘advertising of medicinal products’, within the meaning of that provision, and the decisive factor for distinguishing advertising from mere information. If the message is designed to promote the prescription, supply, sale or consumption of medicinal products, it is advertising for the purposes of Directive 2001/83 (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 52).
36 By contrast, an advertising campaign which seeks to influence not the customer’s choice of a given medicinal product but the choice, taken at a later stage, of the pharmacy from which that customer would purchase that medicinal product does not come within the concept of ‘advertising of medicinal products’ within the meaning of Article 86(1) of Directive 2001/83 (see, to that effect, judgments of 15 July 2021, DocMorris, C‑190/20, EU:C:2021:609, paragraphs 21 and 22, and of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 50).
37 It follows that, in order to determine whether an advertising campaign designed to encourage the purchase of prescription-only medicinal products from a pharmacy’s entire product range falls within the concept of ‘advertising of medicinal products’ within the meaning of Article 86(1) of Directive 2001/83, it is necessary to determine whether that campaign is intended to promote the prescription, supply, sale or consumption of medicinal products, even if unspecified, or whether it is intended only to influence the choice of pharmacy from which the customer will purchase prescription-only medicinal products.
38 In particular, as regards advertising campaigns such as those at issue in the main proceedings, it is necessary, in the light of the foregoing, to distinguish them according to whether the advertising message is limited to prescription-only medicinal products or whether that message also relates to non-prescription medicinal products.
39 On the one hand, an advertising campaign such as the one that is the subject of the order of the Landgericht Köln (Regional Court, Cologne) of 8 May 2013, which offers DocMorris’ customers, in return for sending in their medical prescription and participating in a medication check, a reward of between EUR 2.50 and EUR 20 per prescription, must be regarded, in essence, as giving rise to payment. The same is true of advertising campaigns such as those that are the subject of the orders of that court of 5 November 2013 and 29 September 2015, which gave rise to a price reduction or payment with immediate effect.
40 It follows that the message of those advertising campaigns relates to unspecified prescription-only medicinal products, without concerning other types of medicinal products.
41 However, it cannot be considered that the message of those campaigns promotes the prescription or consumption of unspecified prescription-only medicinal products, since the decision to prescribe such medicinal products is the sole responsibility of the doctor. As is clear from recital 50 of Directive 2001/83, a prescribing doctor is required to carry out his or her functions objectively and, from the point of view of professional conduct, not to prescribe a given medicinal product if it is not fitting for the therapeutic treatment of his or her patient (see, to that effect, judgment of 22 April 2010, Association of the British Pharmaceutical Industry, C‑62/09, EU:C:2010:219, paragraph 40). As the Advocate General observed in point 49 of his Opinion, when the patient receives a medical prescription, the only choice that remains to be made, with regard to the prescription-only medicinal product, is that of the pharmacy from which he or she will buy that medicinal product.
42 It follows that the advertising campaigns referred to in paragraph 39 of the present judgment concern the choice of the pharmacy from which a patient purchases a prescription-only medicinal product, with the result that those campaigns do not come within the concept of ‘advertising of medicinal products’ within the meaning of Article 86(1) of Directive 2001/83 (see, to that effect, judgment of 15 July 2021, DocMorris, C‑190/20, EU:C:2021:609, paragraphs 21 and 22).
43 On the other hand, an advertising campaign such as the one that is the subject of the order of the Landgericht Köln (Regional Court, Cologne) of 26 September 2013 does not solely concern prescription-only medicinal products, but relates also to other products, in particular non-prescription medicinal products. That campaign provided for a referral scheme, under which, when a friend of a DocMorris customer sent in a medical prescription, that customer received a voucher for a stay in a hotel, or an offer to join the German automobile club at a reduced price, while his or her friend was offered a voucher to be used to order non-prescription medicines or health and care products. The same is true of an advertising campaign such as the one that is the subject of the order of that court of 4 November 2014, which also offered DocMorris’ customers, in return for sending in a medical prescription, vouchers to be used for the subsequent purchase of non-prescription medicinal products or health and care products.
44 Thus, unlike the advertising campaigns referred to in paragraph 39 of the present judgment, those referred to in the preceding paragraph encourage the purchase of non-prescription medicinal products. In the absence of an obligation to have recourse to a prescribing doctor, the recipient of the vouchers, attracted by the economic advantage they offer, may use the vouchers to obtain non-prescription medicinal products at a reduced price.
45 It must be held that, by promoting the consumption of non-prescription medicinal products, those advertising campaigns come within the concept of ‘advertising of medicinal products’ within the meaning of Article 86(1) of Directive 2001/83.
46 Such a finding cannot be called into question by the fact that the vouchers offered in the context of the advertising campaigns referred to in paragraph 43 above may also be used for the purchase of goods other than non-prescription medicines, such as health and care products, which may thus be regarded as also being covered by those advertising measures.
47 In the first place, the Court has already held that the concept of ‘advertising of medicinal products’, within the meaning of Article 86(1) of Directive 2001/83, covers advertising which encourages the purchase of medicinal products by offering a sale that is bundled together with the sale of other products sold by a pharmacy (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraphs 53 and 54).
48 In the second place, it is apparent from recital 2 of Directive 2001/83 that the essential aim of that directive is to safeguard public health. In that regard, the Court has already held that advertising of medicinal products is liable to harm public health, in the light of the risks which may arise from excessive or ill-considered use of non-prescription medicinal products (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 40).
49 Indeed, the very particular nature of medicinal products, the therapeutic effects of which distinguish them substantially from other goods, must be emphasised. Those therapeutic effects have the consequence that, if medicinal products are consumed unnecessarily or incorrectly, they may cause serious harm to health, without the patient being in a position to realise that when they are administered (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 41).
50 The essential aim of safeguarding public health would be greatly compromised if Article 86(1) of Directive 2001/83 were to be interpreted as meaning that an advertising campaign that seeks to promote the purchase of non-prescription medicinal products does not come within the concept of ‘advertising of medicinal products’, within the meaning of that provision, and, therefore, avoids the prohibitions, conditions and restrictions laid down by that directive on the subject of advertising, where the message of that advertising campaign also concerns products other than medicinal products.
51 In the third place, given that the concept of ‘advertising of medicinal products’ is defined very broadly in Article 86(1) of Directive 2001/83, that concept covers advertising measures directed at a customer of a pharmacy that, through a referral scheme, seek to promote the consumption of non-prescription medicinal products by a friend of that customer. Since ‘advertising of medicinal products to the general public’ is, in accordance with the wording of that provision, a form of ‘advertising of medicinal products’, the latter concept covers advertising actions which seek to have the message which they convey retransmitted among the members of that public.
52 In the fourth place, it is necessary to distinguish the advertising campaign establishing a referral scheme, which is the subject of the order of the Landgericht Köln (Regional Court, Cologne) of 26 September 2013, from the one at issue in the case which gave rise to the judgment of 15 July 2021, DocMorris (C‑190/20, EU:C:2021:609). That case concerned an advertising campaign run by a pharmacy in the form of a prize draw enabling participants to win everyday items other than medicinal products, participation in that prize draw being subject to making an order for a prescription medicinal product. Accordingly, the message of the advertising campaign at issue in that case did not in any way refer to non-prescription medicinal products.
53 Furthermore, according to the referring court, the advertising campaign which is the subject of the order of the Landgericht Köln (Regional Court, Cologne) of 8 May 2013 is unlawful, under the first sentence of Article 7(1) of the HWG, since such an advertising campaign offers a pharmacy’s customers who send in their medical prescription and participate in a medication check a reward of between EUR 2.50 and EUR 20, without it being possible to know the exact amount of that reward.
54 It is apparent, however, from paragraph 42 of the present judgment that such an advertising campaign does not come within the concept of ‘advertising of medicinal products’ within the meaning of Article 86(1) of Directive 2001/83.
55 In those circumstances, it is still necessary to ascertain whether a national rule such as the one provided for in the first sentence of Article 7(1) of the HWG, which prohibits such advertising, is nevertheless incompatible with other provisions of EU law.
56 Indeed, in accordance with the Court’s settled case-law, in the procedure laid down by Article 267 TFEU providing for cooperation between national courts and the Court of Justice, it is for the latter to provide the national court with an answer which will be of use to it and enable it to determine the case before it. Consequently, even if, formally, the referring court has limited its question to the interpretation of a particular provision of EU law, that does not prevent the Court from providing the referring court with all the elements of interpretation of EU law which may be of assistance in adjudicating in the case pending before it, whether or not the referring court has referred to them in the wording of its questions. It is, in this regard, for the Court to extract from all the information provided by the national court, in particular from the grounds of the decision to make the reference, the points of EU law which require interpretation in view of the subject matter of the dispute in the main proceedings (judgment of 15 July 2021, DocMorris, C‑190/20, EU:C:2021:609, paragraph 23).
57 In that regard, it is not clear from the documents before the Court whether the advertising campaign referred to in paragraph 53 of the present judgment was run solely by means of physical media (see, to that effect, judgment of 15 July 2021, DocMorris, C‑190/20, EU:C:2021:609, paragraph 26) or whether, by contrast, it was carried out in a multifaceted manner, both via the website of the pharmacy concerned and by means of physical media (see, to that effect, judgment of 1 October 2020, A (Advertising and sale of medicinal products online), C‑649/18, EU:C:2020:764, paragraph 48).
58 In the first situation, since the ultimate objective of that advertising campaign is to promote the sale of unspecified prescription-only medicinal products, reference must be made to the provisions of the FEU Treaty relating to the free movement of goods (see, to that effect, judgment of 15 July 2021, DocMorris, C‑190/20, EU:C:2021:609, paragraphs 31 and 32).
59 In the second situation set out in paragraph 57 of the present judgment, since the advertising measure is also disseminated electronically, it comes within the ‘coordinated field’, within the meaning of Article 2(h) of Directive 2000/31, since that measure is intended, as a whole and irrespective of the process by which it is actually carried out, to attract potential consumers to the website of the pharmacy in question and to promote the sale of its products online (see, to that effect, judgment of 1 October 2020, A (Advertising and sale of medicinal products online), C‑649/18, EU:C:2020:764, paragraph 55).
60 It is therefore necessary to examine whether Article 34 TFEU and the relevant provisions of Directive 2000/31 must be interpreted as precluding a national rule which, in order to protect consumers, prohibits an advertising measure by which a pharmacy established in another Member State offers its customers, in return for sending in their medical prescription and participating in a medication check, a reward of between EUR 2.50 and EUR 20, without it being possible to know the exact amount of that reward.
61 In accordance with the settled case-law of the Court, the prohibition, laid down in Article 34 TFEU, of measures having equivalent effect to quantitative restrictions covers any measure of the Member States that is capable of hindering, directly or indirectly, actually or potentially, imports between Member States (see, inter alia, judgments of 11 July 1974, Dassonville, 8/74, EU:C:1974:82, paragraph 5; of 19 October 2016, Deutsche Parkinson Vereinigung, C‑148/15, EU:C:2016:776, paragraph 22; and of 15 July 2021, DocMorris, C‑190/20, EU:C:2021:609, paragraph 34).
62 In that regard, the Court has already be held that a national provision such as the first sentence of Paragraph 7(1) of the HWG, on which the prohibition of the advertising campaign that is the subject of the order of the Landgericht Köln (Regional Court, Cologne) of 8 May 2013 is based and which seeks to regulate the offer of monetary advantages or other promotional gifts with monetary value in the field of the sale of medicinal products, must be regarded as ‘governing selling arrangements’ within the meaning of the case-law of the Court (see, to that effect, judgment of 15 July 2021, DocMorris, C‑190/20, EU:C:2021:609, paragraph 37).
63 As is apparent from the judgment of 24 November 1993, Keck and Mithouard (C‑267/91 and C‑268/91, EU:C:1993:905), such a selling arrangement can, however, fall outside the scope of Article 34 TFEU only if it satisfies the twofold condition that, first, it applies to all relevant traders operating within the national territory and, second, it affects in the same manner, in law and in fact, the marketing of domestic products and that of products from other Member States (see, to that effect, judgment of 15 July 2021, DocMorris, C‑190/20, EU:C:2021:609, paragraphs 35 and 38).
64 As regards the first of those conditions, it should be noted that, in the present case, the HWG applies without distinction to all pharmacies which sell medicinal products on German territory, whether they are established in the territory of the Federal Republic of Germany or in another Member State (judgment of 15 July 2021, DocMorris, C‑190/20, EU:C:2021:609, paragraph 39).
65 As regards the second condition, it should be recalled that the Court has already held that price competition is likely to be a more important parameter of competition for mail-order pharmacies than for traditional pharmacies, since price competition lays the basis for their potential to access the German market directly and to remain competitive in it (see, to that effect, judgment of 19 October 2016, Deutsche Parkinson Vereinigung, C‑148/15, EU:C:2016:776, paragraph 24).
66 In the present case, an advertising campaign by which the customers of a mail-order pharmacy, in return for sending in their medical prescription and participating in a medication check, are offered a reward of between EUR 2.50 and EUR 20 per prescription, seeks to establish price competition with traditional pharmacies.
67 In the light of the foregoing, it must be held that the prohibition of such an advertising measure, as provided for in the German legislation, has a greater impact on pharmacies established in a Member State other than the Federal Republic of Germany than on those which are established within German territory, a fact which could impede market access for products from other Member States more than it impedes such access for domestic products, with the result that such a prohibition constitutes a measure having an equivalent effect to quantitative restrictions.
68 Such an obstacle can be properly justified only if it is appropriate for securing the attainment of that objective and does not go beyond what is necessary in order to attain it (judgment of 19 October 2016, Deutsche Parkinson Vereinigung, C‑148/15, EU:C:2016:776, paragraph 34).
69 In that regard, the referring court observes that the objective of protection pursued by Article 7(1) of the HWG is to prevent, when medicinal products are purchased, the risk, even if only in abstract terms, that the addressees of advertising will be unduly influenced. In its view, the advertising campaign that is the subject of the order of the Landgericht Köln (Regional Court, Cologne) of 8 May 2013 undermines that objective, since, because of the indication of a range, the addressees of the advertisement could overestimate the amount of the reward granted on a case-by-case basis.
70 It follows that the prohibition of that advertising campaign comes, subject to verification by the referring court, within the scope of consumer protection, which constitutes an overriding reason in the public interest capable of justifying an obstacle to the free movement of goods (see, to that effect, judgment of 10 September 2014, Vilniaus energija, C‑423/13, EU:C:2014:2186, paragraph 50).
71 First, as regards the suitability of the national legislation at issue in the main proceedings for attaining the objective of consumer protection, it must be held that it prevents consumers from overestimating the amount of the reward. The risk of overestimation of that reward may be significant for consumers who purchase highly priced medicinal products or who, suffering from a chronic disease, have to buy them regularly.
72 Second, that legislation does not go beyond what is necessary to attain that objective, in so far as it prohibits the advertising campaign that is the subject of the order of the Landgericht Köln (Regional Court, Cologne) of 8 May 2013, which establishes a range for the amount of the reward, without informing consumers of the method of calculating the reward applied by the pharmacy concerned. Thus, even an average consumer who is reasonably well informed and reasonably observant and circumspect (judgments of 13 January 2000, Estée Lauder, C‑220/98, EU:C:2000:8, paragraph 27, and of 16 January 2014, Juvelta, C‑481/12, EU:C:2014:11, paragraph 23) will be unable to calculate the exact amount of that reward.
73 It follows that Article 34 TFEU must be interpreted as not precluding national legislation which prohibits an advertising measure offering customers of a mail-order pharmacy a reward of between EUR 2.50 and EUR 20 per medical prescription, without it being possible to know the exact amount of that reward.
74 It should be noted that Article 85c(1) of Directive 2001/83 provides that Member States are to ensure medicinal products are offered for sale at a distance to the public by means of information society services in accordance with a series of conditions set out therein. However, this obligation is without prejudice to national legislation prohibiting the offer for sale at a distance of prescription medicinal products to the public by means of such services.
75 It follows that, where the Member State of destination authorises such an offer, which appears to be the case here, that Member State may not, so far as relates to such services, as a general rule, pursuant to Article 3(2) of Directive 2000/31, restrict the free movement of information society services from another Member State (see, to that effect, judgment of 1 October 2020, A (Advertising and sale of medicinal products online), C‑649/18, EU:C:2020:764, paragraph 60).
76 In the present case, the prohibition of an advertising campaign, such as the one that is the subject of the order of the Landgericht Köln (Regional Court, Cologne) of 8 May 2013, imposed by a Member State, is such as to restrict the possibility for a pharmacy established in another Member State to make itself known to potential customers in that first Member State and to promote the online sales service relating to the products that it offers to those customers (judgment of 1 October 2020, A (Advertising and sale of medicinal products online), C‑649/18, EU:C:2020:764, paragraph 61).
77 Therefore, such a prohibition must be regarded as a restriction on the freedom to provide information society services.
78 That said, pursuant to Article 3(4)(a) of Directive 2000/31, Member States may, in respect of a given information society service, take measures that derogate from Article 3(2) of that directive, provided, first, that those measures are necessary in the interests of public policy, the protection of public health, public security or the protection of consumers, second, that those measures are taken against an information society service which actually undermines those objectives or constitutes a serious and grave risk to those objectives, and, third, that those measures are proportionate to those objectives (judgment of 1 October 2020, A (Advertising and sale of medicinal products online), C‑649/18, EU:C:2020:764, paragraph 63).
79 As regards the conditions of necessity and proportionality laid down in Article 3(4)(a) of Directive 2000/31, account must be taken of the case-law relating to Articles 34 and 56 TFEU, for the purposes of assessing whether the national legislation at issue complies with EU law, in so far as those conditions largely overlap with the requirements that must be fulfilled by any obstacle to the fundamental freedoms guaranteed in those articles of the TFEU (judgment of 1 October 2020, A (Advertising and sale of medicinal products online), C‑649/18, EU:C:2020:764, paragraph 64).
80 Thus, for the same reasons as those already set out in paragraphs 70 to 72 of the present judgment, it should be noted that Article 3(4)(a) of Directive 2000/31 must be interpreted as not precluding national legislation which prohibits an advertising campaign such as the one that is the subject of the order of the Landgericht Köln (Regional Court, Cologne) of 8 May 2013.
81 Having regard to all the foregoing considerations, the answer to the first question is that Article 86(1) of Directive 2001/83 must be interpreted as meaning that: - the concept of ‘advertising of medicinal products’, within the meaning of that provision, does not cover advertising measures that promote the purchase of unspecified prescription-only medicinal products by offering price reductions and payments; - that concept covers advertising measures that promote the purchase of unspecified prescription-only medicinal products by offering promotional gifts in the form of vouchers for the subsequent purchase of non-prescription medicinal products. Article 34 TFEU and Article 3(4)(a) of Directive 2000/31 must be interpreted as not precluding a national rule which, in order to protect consumers, prohibits an advertising measure by which a pharmacy established in another Member State offers its customers, in return for sending in their medical prescription and participating in a medication check, a monetary reward, without it being possible to know the exact amount of that reward.
82 In view of the answer given to the first question, it must be held that, by its second question, the referring court asks, in essence, whether Article 87(3) of Directive 2001/83 must be interpreted as precluding national legislation which prohibits advertising that promotes the purchase of unspecified prescription-only medicinal products by means of promotional gifts in the form of vouchers corresponding to a certain sum of money or a percentage reduction for the subsequent purchase of other products, such as non-prescription medicinal products.
83 As stated in paragraphs 48 to 49 above, since advertising of medicinal products is liable to harm public health, including when it refers to non-prescription medicinal products, such advertising is the subject of prohibitions, conditions and restrictions which are laid down in Directive 2001/83 (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 59).
84 Furthermore, that directive has brought about complete harmonisation in the field of advertising of medicinal products. Consequently, where the option of laying down different rules is not given to Member States expressly, the only conditions which they can place on advertising for medicinal products are those laid down by that directive (judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 60).
85 As was noted in paragraph 45 above, the advertising measures which are the subject of the present question referred for a preliminary ruling, although directed at the purchase of prescription-only medicinal products, promote only the consumption of non-prescription medicinal products. It follows that, since their purpose is to promote the consumption of the latter type of medicinal product, Article 88(1)(a) of Directive 2001/83 is not applicable to them.
86 As regards advertising measures directed at the general public which promote the consumption of non-prescription medicinal products, such as those referred to in the national provision at issue in the main proceedings, amongst the conditions and restrictions framing the authorisation in principle to which that advertising is subject under Article 88(2) of Directive 2001/83, are those provided for in Article 87 of that directive (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 61).
87 Thus, even if it follows from Article 88(2) of Directive 2001/83 that advertising of non-prescription medicinal products is permitted, in order to prevent risks to public health in accordance with the essential aim of safeguarding public health set out in recitals 2 and 45 of that directive, Member States must prohibit the inclusion, in advertising of such medicinal products directed at the general public, of material which is of such a nature as to promote the irrational use of such medicinal products (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 63).
88 In that regard, Article 87(3) of Directive 2001/83 requires that advertising should encourage the rational use of the medicinal product by presenting it objectively and without exaggerating its properties and that it should not be misleading. That provision reiterates the need, expressed in recital 45 of that directive, to prevent excessive and ill-considered advertising that could affect public health (see, to that effect, judgment of 8 November 2007, Gintec, C‑374/05, EU:C:2007:654, paragraph 55).
89 As regards non-prescription medicinal products, the Court has already held that it is frequently the case that the end consumer himself or herself evaluates, without the assistance of a doctor, the usefulness or need to purchase such medicinal products. However, that consumer does not necessarily have the specific and objective knowledge enabling him or her to evaluate their therapeutic value. Advertising may therefore exercise a particularly strong influence on the evaluation and choice made by that consumer, both as regards the quality of the medicinal product and the amount to purchase (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 65).
90 Accordingly, advertising that distracts the consumer from an objective evaluation of the need to take such medicine encourages the irrational and excessive use of that medicinal product (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 67 and the case-law cited).
91 In the present case, by using the vouchers in question in the main proceedings, the consumer may obtain, at a reduced price, products from the entire range of products of the pharmacy concerned, with the exception of prescription-only medicinal products. A consumer may, for example, choose between buying non-prescription medicinal products and purchasing other consumer products, such as health and care products. Advertising campaigns such as those covered by the question referred for a preliminary ruling thus treat non-prescription medicinal products in the same way as other consumer products offered by a pharmacy.
92 Such equivalent treatment is liable to lead to the irrational and excessive use of non-prescription medicinal products (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 68), since it conceals the very particular nature of those medicinal products, the therapeutic effects of which distinguish them substantially from other goods. That equivalent treatment distracts the consumer from an objective evaluation of the need to take those medicinal products.
93 In those circumstances, it must be held that, inasmuch as it prevents the use of advertising material that encourages the irrational and excessive use of non-prescription medicinal products, a prohibition such as the one provided for by the legislation at issue in the main proceedings meets the essential aim of safeguarding public health (see, to that effect, judgment of 22 December 2022, EUROAPTIEKA, C‑530/20, EU:C:2022:1014, paragraph 69).
94 In the light of the foregoing considerations, the answer to the second question is that Article 87(3) of Directive 2001/83 must be interpreted as not precluding national legislation which prohibits advertising measures promoting the purchase of unspecified prescription-only medicinal products by offering promotional gifts in the form of vouchers corresponding to a certain sum of money or a percentage reduction for the subsequent purchase of other products, such as non-prescription medicinal products.
95 In light of the answer given to the first question, there is no need to answer the third question.
96 Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the referring court, the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs of those parties, are not recoverable.