Provisional text

OPINION OF ADVOCATE GENERAL

MACIEJ SZPUNAR

delivered on 9 December 2021 ( )

Case C-530/20

SIA ‘EUROAPTIEKA’

intervener:

Ministru kabinets

[Request for a preliminary ruling from the Latvijas Republikas Satversmes tiesa (Constitutional Court, Latvia)]

(Reference for a preliminary ruling – Medicinal products for human use – Advertising of medicinal products – Advertising encouraging the purchase of medicinal products by invoking their price – Special clearance sales or sales bundled with other medicinal products, including at reduced prices, or other goods)





I. Introduction

1. In the present case, the referring court is asking the Court of Justice to interpret the provisions of Directive 2001/83/EC ( ) to clarify whether, in view of the nature and extent of the harmonisation achieved by that directive, a Member State may prohibit the dissemination of information that encourages the purchase of medicinal products not only when it concerns a specific medicinal product but also when it concerns non-prescription medicinal products in general.

II. Legal context

A. European Union law

2. Articles 86 to 100 of Directive 2001/83 concerning advertising of medicinal products are contained in Titles VIII and VIIIa thereof, entitled ‘Advertising’ and ‘Information and advertising’ respectively.

3. Article 86(1) of that directive states that:

‘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,

[…]’

4. Article 87(3) of that directive states, in particular, that ‘the advertising of a medicinal product shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties’.

5. Article 90 of that directive sets out the list of elements that must not be included in the advertising of a medicinal product to the general public.

B. Latvian law

6. Article 18.12 of the Ministru kabineta noteikumi Nr. 378 ‘Zāļu reklamēšanas kārtība un kārtība, kādā zāļu ražotājs ir tiesīgs nodot ārstiem bezmaksas zāļu paraugus’ (Decree No 378 of the Council of Ministers laying down detailed rules for the advertising of medicinal products and the conditions under which manufacturers of medicinal products are authorised to provide free samples of medicinal products to doctors) of 17 May 2011 (Latvijas Vēstnesis, 2011, No 78) (‘the contested provision’) specifies as follows:

‘It shall be prohibited to include in advertising to the general public of a medicinal product any information which encourages the purchase of the medicinal product by justifying the need to purchase that medicinal product on the basis of its price, by announcing a special clearance sale, or by indicating that the medicinal product is sold as a bundle together with other medicinal products (including at a reduced price) or other types of product.’

III. The facts of the case in the main proceedings, the procedure before the Court and the questions referred for a preliminary ruling

7. SIA ‘EUROAPTIEKA’ is a company established in Latvia that carries out pharmaceutical activities and is part of a group owning a network of pharmacies and retail distribution companies of medicinal products in that Member State. According to Latvian law, pharmacies are permitted to supply products other than medicinal products.

8. In March 2016, EUROAPTIEKA announced a promotion on its website and in its monthly magazine, offering a 15% reduction on the purchase price of any medicinal product where at least three items were purchased.

9. By a decision of 1 April 2016, based on the contested provision, the Veselības inspekcijas Zāļu kontroles nodaļa (Medicinal Product Control Section of the Health Inspectorate, Latvia) banned EUROAPTIEKA from the dissemination of advertising relating to that promotion (‘the decision of 1 April 2016’).

10. EUROAPTIEKA lodged a constitutional complaint before the referring court relating to the compliance of the contested provision with Articles 100 and 105 of the Latvian constitution, enshrining freedom of expression and the right to property respectively, on the one hand, and Article 288(3) TFEU, on the other hand, and proceedings were then commenced in 2020.

11. In support of its complaint, EUROAPTIEKA claims that the contested provision does not relate solely to the advertising of a particular medicinal product but also to the advertising of medicinal products in general. Consequently, this provision restricted its right to advertise to the public with a view to promoting its brand and enhancing its reputation and prohibited it from informing consumers about the conditions of the contract of sale relating to the products offered to them. That provision therefore reduced the number of regular customers at its pharmacies and, in doing so, infringed its right to property, since customers should be considered as property within the meaning of Article 1 of Protocol No 1 to the Convention for the Protection of Human Rights and Fundamental Freedoms, signed in Rome on 4 November 1950.

12. On the other hand, and as regards the part of its complaint that underlies the questions referred for a preliminary ruling, EUROAPTIEKA considered that the legislature had not empowered the Council of Ministers to enact a provision such as the contested provision to implement Directive 2001/83. Indeed, this directive does not apply to all advertising relating to the pharmaceutical sector or medicinal products in general but only to advertising relating to specific medicinal products. Furthermore, that directive provides for full harmonisation in the field of advertising of medicinal products and does not allow Member States to impose additional requirements in their legislation. By means of the contested provision, the Council of Ministers extended the list of prohibited methods of advertising set out in Article 90 of the directive and, in doing so, infringed the third paragraph of Article 288 TFEU.

13. The Council of Ministers argued that the fact that the contested provision imposes stricter advertising requirements for medicinal products does not mean that it has exceeded the power granted to it by the legislature to implement the provisions of Directive 2001/83. Indeed, the definition of ‘advertising of medicinal products’ contained in that directive is broad. Furthermore, Article 87(3) of that directive prohibits advertising that encourages the irrational use of a medicinal product, and that prohibition applies to the use of any medicinal product.

14. Referring to the judgment in Gintec, ( ) the referring court held that the Court of Justice had ruled that Directive 2001/83 brought about a complete harmonisation in the field of advertising medicinal products, expressly listing the cases in which Member States are authorised to adopt provisions departing from the rules laid down by that directive. The referring court considers that the contested provision should be considered legislation on the ‘advertising of medicinal products’ within the meaning of that directive. In addition, that directive does not preclude the contested provision, in so far as the prohibition provided for in that provision is consistent with the objectives pursued by Directive 2001/83.

15. That being so, the referring court has doubts as to the interpretation to be given to Articles 86(1), 87 and 90 of Directive 2001/83.

16. First, the referring court notes that, in accordance with the first indent of Article 89(1)(b) of Directive 2001/83, any advertisement for a medicinal product must include the name and, where appropriate, the common name of the medicinal product. That could indicate that only advertising of identifiable medicinal products would be ‘advertising of medicinal products’ under that directive.

17. The referring court states that the contested provision does not require the inclusion of information on specific medicinal products, such as their names, in what it considers to be advertising to the general public, but does prohibit certain information in the advertising of medicinal products, such as their price. Consequently, in so far as this provision governs not the information on medicinal products themselves and their names, but the information on their prices, the activities referred to in that provision could be considered not as advertising within the meaning of Directive 2001/83, but as a form of door-to-door information, such that the provision in question does not fall within the scope of that directive.

18. Second, the referring court states that the contested provision lists a prohibition that does not reflect any of the prohibited methods of advertising referred to in Article 90 of Directive 2001/83. The question therefore arises as to whether Member States are entitled to extend the list of prohibited forms of advertising set out in that provision. The referring court states that, specifically, Article 87(3) of that directive, read in the light of recital 45 thereof, could be interpreted as allowing Member States to prohibit manifestly excessive and ill-considered advertising of medicinal products, which as such could affect public health.

19. In those circumstances, the Latvijas Republikas Satversmes tiesa (Constitutional Court, Latvia) decided, by a decision of 6 October 2020, received at the Court on 20 October 2020, to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

‘(1) Must the activities to which the contested provision refers be regarded as advertising of medicinal products within the meaning of Title VIII of Directive 2001/83/EC (entitled “Advertising”)?

(2) Must Article 90 of Directive 2001/83/EC be interpreted as precluding legislation of a Member State which extends the list of prohibited methods of advertising and imposes stricter restrictions than those expressly provided for in Article 90 of that directive?

(3) Must the legislation at issue in the main proceedings be considered to restrict advertising of medicinal products in order to encourage the rational use of such products, within the meaning of Article 87(3) of Directive 2001/83/EC?’

20. Written observations have been submitted by EUROAPTIEKA, by the Latvian, Greek and Polish Governments and by the European Commission. No hearing has taken place.

IV. Analysis

A. The subject matter of the dispute in the main proceedings

21. A reading of certain passages in the parties’ submissions may suggest that the case in the main proceedings concerns the legality, under the Latvian Constitution and EU law, of the decision of 1 April 2016 by which EUROPATIEKA was prohibited from disseminating the advertising at issue in the main proceedings.

22. However, EUROPATIEKA’s appeal to the referring court does not appear to concern the legality of that decision.

23. In fact, it is the compatibility of the contested provision with the Latvian Constitution and with EU law that EUROPATIEKA is challenging in this action, brought several years after the decision of 1 April 2016 was adopted on the basis of the contested provision. ( )

24. Consequently, it is not the actions of EUROAPTIEKA but the normative content of the contested provision that should be interpreted in the light of Directive 2001/83.

25. With regard to the clarifications to be provided to the referring court in order to enable it to decide on the compatibility of the contested provision with EU law, it is appropriate, in the light of the statement of reasons that led that court to question the interpretation of Directive 2001/83 and taking into account the allegations made by EUROAPTIEKA in its action before the referring court, to determine, first, whether the activities covered by the contested provision fall within the concept of ‘advertising of medicinal products’ within the meaning of Article 86(1) of that directive (first question referred). If the answer to that question is in the affirmative, it is necessary, as a second step, to provide the referring court with clarifications enabling it to ascertain whether, having regard to the latitude available to the Member State when implementing that directive, the Latvian legislature has correctly transposed it into national law (second and third questions referred).

B. The first question referred

26. By its first question referred, the referring court is seeking to ascertain whether Article 86(1) of Directive 2001/83 should be interpreted in the sense that the dissemination of information that encourages the purchase of a medicinal product by justifying the need to purchase that medicinal product on the basis of its price, by announcing a special clearance sale, or by indicating that the medicinal product is sold as a bundle together with other medicinal products (including at a reduced price) or other types of product falls within the concept of ‘advertising of medicinal products’ within the meaning of that provision, even when that information concerns not a specific medicinal product but non-prescription medicinal products in general.

27. Indeed, first and foremost, although the first question referred makes reference to Title VIII of Directive 2001/83, entitled ‘Advertising’, the definition of the concept of ‘advertising of medicinal products’ provided in Article 86(1) of that directive applies for all provisions under that title (‘For the purposes of this Title, “advertising of medicinal products” shall include …’). In order to answer this question, it is therefore necessary to interpret this provision primarily.

28. It is certainly true that Title VIIIa of Directive 2001/83 also concerns the field of advertising of medicinal products. This title contains, inter alia, specific rules on advertising to the general public, set out in Articles 88a to 90. ( ) However, advertising to the general public constitutes a category of ‘advertising of medicinal products’ within the meaning of Article 86(1) of that directive.

29. Second, I should point out that whilst the contested provision refers to the three cases described in point 26 of this Opinion, the referring court’s questions concern whether those three cases are covered by Article 86(1) of Directive 2001/83 or are outside that provision for reasons common to all of them.

30. While, in my view, those three cases can potentially be examined separately in the context of the second and third questions referred, we should nonetheless clarify, in the context of the first question, whether the activities covered by the contested provision are excluded from the scope of Directive 2001/83 where they concern non-prescription medicinal products in general.

31. I must also point out, having regard to the content of the request for a preliminary ruling and the information provided by the Latvian Government, that the activities covered by the contested provision relate to medicinal products authorised in Latvia and not subject to medical prescription in that Member State. Indeed, advertising of unauthorised medicinal products ( ) and those subject to medical prescription ( ) is prohibited by EU law.

32. I will therefore analyse the first question referred, as a first step, from the point of view of a textual, systematic and teleological interpretation of Article 86(1) of Directive 2001/83, before comparing the outcome of my analysis with the lessons that can be drawn from the recent judgments of the Court, in particular the judgments in A (Advertising and sale of medicinal products online) ( ) and DocMorris, ( ) to which the parties have referred in their written observations and their responses to the Court’s written questions.

1. Textual interpretation

33. Article 86(1) of Directive 2001/83 defines the concept of ‘advertising of medicinal products’ as ‘any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medicinal products …’

34. I must first point out that this provision, on the one hand, refers to medicinal products in the plural and, on the other, covers ‘any form’ of advertising.

35. Second, in view of the normative content of the contested provision, it should be noted that the notion of ‘advertising of medicinal products’ includes, inter alia, ‘advertising of medicinal products to the general public’. A priori, the activities covered by this provision seem to fit perfectly within this definition.

36. Third, the Court has already indicated, with regard to the wording of Article 86(1) of Directive 2001/83, that the purpose of the message constitutes the fundamental defining characteristic of advertising within the meaning of this provision, and the decisive factor for distinguishing advertising from mere information. ( )

37. As was recognised by the referring court, the question as to whether the dissemination of information has a promotional objective must be determined by undertaking a detailed examination of all the relevant circumstances of the case, which is for the national court. ( ) The Court has nonetheless identified a non-exhaustive list of criteria and circumstances that are relevant for determining whether a communication should be classified as ‘advertising’, such as the identity of the author of the communication, its purpose and content, the group of addressees and the characteristics of the media used. ( )

38. By its first question, the referring court is simply seeking clarification to enable it to determine whether the fact that the dissemination of information concerns not specific medicinal products but medicinal products in general excludes that dissemination from the concept of ‘advertising of medicinal products’ within the meaning of Article 86(1) of Directive 2001/83.

39. As can be seen from point 33 of this Opinion, a communication aimed at promoting ‘the prescription, supply, sale or consumption of medicinal products’ must be considered as falling within that definition.

40. In that context, in so far as the definition of the concept of ‘advertising of medicinal products’ uses the term ‘or’ to list the purposes pursued by advertising (‘the prescription, supply, sale or consumption of medicinal products’), the simple fact that the dissemination of information is intended to promote the sale of medicinal products – and not necessarily their consumption, which is sometimes difficult to identify – is sufficient to establish that such dissemination falls within that definition.

41. In common with all of the parties, with the exception of EUROAPTIEKA, I am of the opinion that the dissemination of information about non-prescription medicinal products is, in principle, likely to influence a consumer’s purchasing decision. What matters is not the medicinal product that the consumer buys, but the fact that the dissemination of information induces the consumer to make a purchase of a product falling within the broad category of non-prescription medicinal products. Furthermore, if we were to consider that the dissemination of information about medicinal products in general does not constitute advertising, this would also exclude from the scope of Titles VIII and VIIIa of Directive 2001/83 the dissemination of information about a certain category of medicinal products intended to treat a specific condition. Moreover, we cannot exclude the possibility that such a category of medicinal products is automatically associated by consumers with a specific medicinal product, even if its name is not mentioned in that information.

42. More importantly, as is clear from its wording, the contested provision prohibits the dissemination of information that encourages the purchase of medicinal products. It therefore seems that, in order to fall within the prohibition stipulated by that provision, that dissemination of information must promote (‘encourage’) the sale (‘purchase’) of medicinal products. Thus, subject to the verifications to be undertaken by the referring court, the advertising purpose constitutes a precondition for the application of the contested provision and designates the scope of application of that provision. In turn, that provision must therefore be regarded as falling within the scope of Directive 2001/83 in so far as Titles VIII and VIIIa of that directive harmonise the field of advertising of medicinal products. ( )

43. That conclusion is supported by a systematic interpretation of Directive 2001/83.

2. Systematic interpretation

44. In terms of the interpretation of the concept of ‘advertising of medicinal products’, the Court considered that Article 86(1) of Directive 2001/83 lays down a general rule applicable to any situation where it is necessary to determine whether an activity constitutes advertising of medicinal products. ( ) Furthermore, the Court has clarified that Article 87 of that directive contains general principles applicable to all types and parts of advertising for medicinal products. ( ) In substance, with particular regard to advertising to the general public, Article 88 of that directive also sets out general principles.

45. Thus, first, the notion of ‘advertising of medicinal products’ should be defined broadly, to ensure it also covers situations where it is less obvious as to whether they fall within the scope of Directive 2001/83.

46. In that context, the fact that the first indent of Article 89(1)(b) of Directive 2001/83, contained in Title VIIIa thereof, stipulates that any advertising of a medicinal product to the general public must include the name of the medicinal product does not appear to me to be decisive, given that this is only one of the categories of advertising of medicinal products referred to in the general concept stated in Article 86(1) of that directive. Moreover, if, as the Polish Government argues, advertising of medicinal products could only relate to a specific product, the obligation to clearly identify that product would be included not in the specific provisions relating to certain forms of advertising but in the general provisions of Directive 2001/83 governing such advertising.

47. Second, I understand the Court’s thinking whereby Article 86(1) of Directive 2001/83 applies in all cases where it is necessary to determine whether an activity has the characteristics of advertising of a medicinal product in the sense that the EU legislature, having regard to the framework against which the compatibility of advertising activities relating to medicinal products with EU law must be assessed, wished to give precedence not to the provisions of primary law but to those of that directive.

48. Indeed, to consider that a provision such as that at issue in the main proceedings falls outside the scope of Article 86(1) of Directive 2001/83 would imply, at least in a cross-border situation, that the normative content of this provision and its implications for the internal market should be examined in the light of primary law and, more specifically, the fundamental freedoms enshrined in the TFEU.

49. As illustrated by the debate between the parties, in which EUROAPTIEKA argues that the contested provision does not relate to the medicinal products sold by a pharmacy but to the pharmacy’s activity, we cannot rule out the consideration that a national provision introducing prohibitions on the advertising of medicinal products in general is likely to be linked, in the case of a cross-border situation, both to the free movement of goods and to the freedom to provide services. The Court will examine such a national provision, in principle, in the light of only one of these two fundamental freedoms if it appears that one of them is secondary to the other and can be linked to it.

50. In the present case, the contested provision does not concern the practising of the profession of pharmacist or the services associated with sales as such, but covers a certain form of advertising campaign for medicinal products offered for sale. ( )

51. In terms of the free movement of goods, the contested provision could be considered as ‘governing selling arrangements’, according to the case-law of the Court, and as satisfying the two conditions resulting from the case-law in Keck and Mithouard, ( ) and therefore falls outside the scope of Article 34 TFEU. ( )

52. Consequently, the Member States are free to prohibit activities such as those covered by the contested provision and such prohibitions are, in principle, not subject to any checks as to their compatibility with Directive 2001/83 and/or with the fundamental freedoms enshrined in the TFEU. At the same time, Member States are not obliged to enact such prohibitions, although these activities are likely to influence consumer behaviour. ( ) I am of the view that it is for these reasons that, as I mentioned in point 47 of this Opinion, the legislature has given preference to Directive 2001/83 as the framework against which the compatibility of advertising activities relating to medicinal products with EU law should be assessed.

53. In these circumstances, the character of Article 86(1) of Directive 2001/83 as a general rule pleads in favour of an interpretation whereby advertising of medicinal products in general, such as that covered by the contested provision, also falls within the notion of ‘advertising of medicinal products’ within the meaning of that provision. That conclusion is supported by a teleological interpretation of that directive.

3. Teleological interpretation

54. An analysis of the Court’s case-law suggests that, from the point of view of teleological interpretation, the concept of ‘advertising of medicinal products’, within the meaning of Article 86 of Directive 2001/83, should be defined in such a way as to include any door-to-door information, canvassing activity or inducement that could adversely affect public health.

55. Indeed, safeguarding public health is the essential objective of Directive 2001/83. Because of their therapeutic effects, medicinal products differ substantially from other goods. Those 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. ( )

56. As the Court has recognised, we cannot exclude the possibility that certain risks may also arise from the use of medicinal products not subject to medical prescription. ( ) According to the Latvian Government, these risks concern, in particular, people who consume various medicinal products without consulting a doctor. The Latvian Government believes that even seemingly harmless medicinal products can have undesirable side effects when used in combination with other medicinal products. In addition, taking several over-the-counter medicinal products containing the same component could lead to a significant overdose.

57. In recognising these risks, the EU legislature has laid down, in Article 88(1) and (2) and Articles 89 and 90 of Directive 2001/83, which are included in Title VIIIa thereof, read in the light of recital 45 of that directive, that advertising to the general public in relation to medicinal products not subject to medical prescription is not prohibited but, rather, permitted, subject to the conditions and restrictions laid down by that directive. ( )

58. These restrictions include the general restriction described in Article 87(3) of Directive 2001/38, whereby the advertising of a medicinal product must encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties. In my view, this provision is intended to prevent not the advertising of a particular medicinal product, but advertising that could lead to the irrational use of medicinal products.

59. Furthermore, in my view, it is clear from the case-law that the Court, in interpreting the concept of ‘advertising of medicinal products’, has endeavoured to take account of the importance of the objective of safeguarding public health in so far as its interpretation makes it possible to achieve that objective. ( )

60. In this respect, as I mentioned, advertising of medicinal products in general can influence consumer behaviour, ( ) which runs counter to the objective of safeguarding public health and may cause health risks for those consumers. ( )

61. It follows that, like the textual and systematic interpretation, the teleological interpretation of the concept of ‘advertising of medicinal products’ supports an affirmative answer to the first question referred. The considerations based on these interpretations are not called into question by the lessons that can be drawn from the judgments in A (Advertising and sale of medicinal products online) ( ) and DocMorris, ( ) as those rulings cannot be transposed to this case.

4. The A (Advertising and sale of medicinal products online) judgment

62. As a reminder, the Court found, in paragraph 50 of the judgment in A (Advertising and sale of medicinal products online), ( ) that Articles 86 to 100 of Directive 2001/83, which are included in Titles VIII and VIIIa of that directive, are intended to regulate the content of the advertising message and the manner of advertising for particular medicinal products, but do not govern advertising of online sales services relating to medicinal products. According to the Court, therefore, those provisions must not be taken into account, in particular, when examining the question as to whether EU law precludes the application of national legislation prohibiting pharmacies from making promotional offers aimed at granting a discount on the total price of the order of medicinal products where it exceeds a certain amount.

63. A priori, the advertising campaign at issue in the case that gave rise to the judgment in A (Advertising and sale of medicinal products online) ( ) therefore seems to be similar to those prohibited by the contested provision in this case. That similarity may suggest that this judgment is transposable to the present case, such that Directive 2001/83 would not be relevant for answering the first question referred.

64. However, the context of the case in which gave rise to the judgment in A (Advertising and sale of medicinal products online) ( ) is very different from that of this case.

65. The national legislation at issue in the former case, which prohibited pharmacies, in particular, from making promotional offers aimed at granting a discount on the overall price, only indirectly concerned medicinal products and their advertising, ( ) whereas the contested provision expressly and directly concerns the advertising of a medicinal product to the general public.

66. More importantly, the question posed in the case that gave rise to the judgment in A (Advertising and sale of medicinal products online) ( ) concerned, in essence, as can be seen from its wording and from paragraph 28 of that judgment, the conformity of national legislation with EU law, applied by the Member State of destination of an online sales service relating to medicinal products not subject to medical prescription, to the provider of that service established in another Member State. More specifically, the referring court in this case wished to compare this national legislation with Article 34 TFEU, Article 85c of Directive 2001/83 and/or Article 3 of Directive 2000/31/EC. ( )

67. Having found that online sales services for medicinal products are not excluded from the scope of Directive 2000/31 ( ) and that Article 85c of Directive 2001/83 refers, in particular, to the provisions of that first directive, the Court examined the question referred in the light of Directive 2000/31. Indeed, according to the logic underlying Directive 2000/31, a provider of an information society service is, as a general rule, subject to the national legislation of the Member State where it is established (the Member State where the services originate). Requirements relating to information society services, which fall within the coordinated field, may therefore originate in the Member State of origin or – within the limits imposed by Article 3(4) of Directive 2000/31 – in other Member States. However, in the present case, the legislation concerned is that of the Member State in which the service provider is established.

5. The DocMorris judgment

68. In the judgment in DocMorris, ( ) which was delivered after the date when the questions in this case were referred for a preliminary ruling, the Court was asked to rule on the question as to whether the provisions of Title VIII of Directive 2001/83, and in particular Article 87(3) of that directive, preclude national legislation that prohibits a pharmacy that sells medicinal products by mail order from organising an advertising campaign in the form of a prize competition allowing participants to win everyday items other than medicinal products, with participation in that competition being conditional on the submission of an order form for a medicinal product for human use subject to a medical prescription, accompanied by that prescription.

69. In that judgment, the Court held that an advertising campaign of that kind did not fall within the scope of the provisions of Title VIII of Directive 2001/83.

70. More specifically, the Court held that the advertising in question concerned not a specific medicinal product but the entire range of medicinal products subject to medical prescription offered for sale by the pharmacy in question. Before reaching that conclusion, the Court observed, in paragraph 21 of that judgment, that that advertising campaign was not intended to influence the customer’s choice of a given medicinal product, but the choice of the pharmacy from which that customer purchases that medicinal product, a choice which takes place following that of the medicinal product.

71. Indeed, what is important from the point of view of teleological interpretation is that the advertising campaign was not such as to encourage the irrational use of medicinal products, unlike the activities covered by the contested provision. The purchase of medicinal products was conditional on obtaining a medical prescription, under the control of persons authorised to prescribe them.

72. However, for the reasons already mentioned in point 41 of this Opinion, the activities covered by the contested provision are likely to induce consumers to buy more medicinal products also when they concern medicinal products not subject to medical prescription in general. Indeed, where it is clearly stated in the relevant national legislation that the advertising concerns medicinal products – as in this case – the advertising rules must apply even if no specific medicinal product is expressly mentioned in the advertising.

6. Conclusion on the first question

73. Taking into consideration the unequivocal conclusions resulting from the textual, systematic and teleological interpretation of Article 86(1) of Directive 2001/83, that provision should be interpreted in the sense that the dissemination of information that encourages the purchase of a medicinal product by justifying the need to purchase that medicinal product on the basis of its price, by announcing a special clearance sale, or by indicating that the medicinal product is sold as a bundle together with other medicinal products (including at a reduced price) or other types of product falls within the concept of ‘advertising of medicinal products’ within the meaning of that provision, even when that information concerns not a specific medicinal product but non-prescription medicinal products in general.

C. The second and third questions

74. By its second and third questions referred, which should be examined together, the referring court is asking, essentially, first, whether Article 87(3) and Article 90 of Directive 2001/83 should be interpreted in the sense that these provisions preclude a Member State enacting prohibitions that do not reflect those listed in Article 90 of that directive, where those prohibitions are aimed at advertising that promotes the irrational use of medicinal products and, second, whether the contested provision enacts such prohibitions.

75. I must note, first, that although the second question referred, as formulated by the referring court, appears to be based on the premiss that Article 90 of Directive 2001/83 concerns prohibited forms of advertising, that provision nevertheless lays down prohibitions relating to the content of advertising to the general public of a medicinal product. ( ) Second, the referring court states that, in any event, the prohibitions laid down by the contested provision do not correspond to those set out in Article 90 of Directive 2001/83.

1. Admissibility

76. Before moving on to examine these questions, I must point out that, in its written observations, EUROAPTIEKA argues, albeit implicitly, that the second and third questions referred by the referring court are inadmissible. In its view, these questions are not relevant to the resolution of the case, since they concern the interpretation of the provisions of Directive 2001/83 and the contested provision does not fall within the scope of that directive.

77. It should be noted that, by its first question referred, the referring court is seeking to establish, in substance, whether the contested provision falls within the scope of Directive 2001/83 and that it is only necessary to examine the second and third questions if the first question is answered in the affirmative. In view of my affirmative answer to that first question, there is no reason for me to consider that the second and third questions are manifestly irrelevant to the resolution of the case in the main proceedings. In my opinion, these questions are therefore admissible.

2. Substance

78. It is clear from the Court’s case-law that the first part of the second and third questions should be answered in the negative.

79. Indeed, these two questions, read together, are based on a reading of Directive 2001/83 according to which Article 90 of that directive establishes an exhaustive list of prohibitions relating to the content of advertising of a medicinal product to the general public, while Article 87(3) of that directive allows Member States to enact other prohibitions where these promote the rational use of the medicinal product.

80. This interpretation of Directive 2001/83 was applied by the Court in the judgment in Gintec, ( ) to which the referring court refers.

81. In that judgment, the Court specifically ruled on the question as to whether, in the absence of an express prohibition in Directive 2001/83 on the advertising of medicinal products by means of prize draws, such advertising is permitted or prohibited by Article 87(3) of that directive. ( )

82. In that regard, the Court held, in essence, that although Directive 2001/83 does not lay down specific rules on the advertising of medicinal products in the form of prize draws, such advertising is prohibited, inter alia, under Article 87(3) of that directive, in so far as it promotes the irrational use of that medicinal product and leads to its direct distribution to the public and the giving of free samples.

83. In reaching this conclusion, the Court noted, first, that such advertising is not acceptable in the light of the need to prevent excessive and ill-considered advertising that could affect public health. The Court then indicated that Article 87(3) of that directive reiterates that need, by requiring that advertising of medicinal products must encourage their rational use. ( ) Finally, the Court agreed with the position expressed by some governments and found that the advertising of a medicinal product by means of prize draws encourages the irrational and excessive use of that medicinal product, by presenting it as a gift or a prize, thus distracting the consumer from an objective evaluation of whether he or she needs to take such medicine. ( )

84. It therefore follows, with regard to the first part of the second and third questions referred, that Article 87(3) and Article 90 of Directive 2001/83 should be interpreted in the sense that these provisions do not preclude a Member State enacting prohibitions that do not reflect those listed in Article 90 of that directive, where those prohibitions are aimed at advertising that promotes the irrational use of medicinal products.

85. As regards the second part of these questions, it should be stressed that the contested provision does not prohibit the dissemination of simple information about the price of medicinal products. Neither does it concern an obligation to set a certain price for medicinal products. On the other hand, this provision prohibits the dissemination of information that encourages the purchase of a medicinal product by invoking its price, the special nature of the sale or its sale bundled with other medicinal or other products, including at a reduced price.

86. As I indicated in point 72 of this Opinion, this provision is therefore aimed at activities that are likely to induce consumers to buy more medicinal products, without necessarily linking the purchase to the benefit for their health.

87. In this context, as the Commission observes in its responses to the Court’s written questions, consumers are always influenced by price and may be induced to buy more than necessary if there is a special offer or discount. When consumers buy medicinal products, it is the benefit for their health that should take precedence (prevention or treatment) and not possible economic interests or financial advantages linked to the purchase in the context of special sales or in a bundle with other medicinal or other products.

88. A purchase of medicinal products that is not guided by an interest in the health of the consumer may, in turn, lead to the consumption of medicinal products without taking this interest into account. Even without considering the risks identified by the Latvian Government, ( ) this constitutes the very definition of irrational use of medicinal products.

89. Furthermore, the fact that the effective protection of health and life of humans demands, inter alia, that medicinal products be sold at reasonable prices ( ) cannot obscure the need, recognised in recital 45 of Directive 2001/83, to prevent excessive and ill-considered advertising that could affect public health. As the Court held in the judgment in Gintec, ( ) that imperative is reflected in Article 87(3) of the directive, under which advertising of medicinal products must encourage their rational use.

90. Consequently, the response to the second part of the second and third questions referred must be that the prohibitions relating to advertising that encourages the purchase of a medicinal product by justifying the need to purchase that medicinal product on the basis of its price, by announcing a special clearance sale, or by indicating that the medicinal product is sold as a bundle together with other medicinal products (including at a reduced price) or other types of product are aimed at advertising that promotes the irrational use of medicinal products.

V. Conclusion

91. In the light of the above considerations, I propose that the Court should give the following responses to the questions referred for a preliminary ruling by the Latvijas Republikas Satversmes tiesa (Constitutional Court, Latvia):

(1) Article 86(1) 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, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, should be interpreted in the sense that the dissemination of information that encourages the purchase of a medicinal product by justifying the need to purchase that medicinal product on the basis of its price, by announcing a special clearance sale, or by indicating that the medicinal product is sold as a bundle together with other medicinal products (including at a reduced price) or other types of product may fall within the concept of ‘advertising of medicinal products’ within the meaning of that provision, even when that information concerns not a specific medicinal product but non-prescription medicinal products in general.

(2) Article 87(3) and Article 90 of Directive 2001/83 should be interpreted as not precluding a Member State from enacting prohibitions that do not reflect those listed in Article 90 of that directive, where those prohibitions are aimed at advertising that promotes the irrational use of medicinal products.

The prohibitions relating to advertising that encourages the purchase of a medicinal product by justifying the need to purchase that medicinal product on the basis of its price, by announcing a special clearance sale, or by indicating that the medicinal product is sold as a bundle together with other medicinal products (including at a reduced price) or other types of product are aimed at advertising that promotes the irrational use of medicinal products.