Provisional text

ADDITIONAL OPINION OF ADVOCATE GENERAL

SZPUNAR

delivered on 9 June 2022 ( )

Case C‑530/20

SIA ‘EUROAPTIEKA’

in the presence of the

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 for medicinal products – Advertising encouraging the purchase of medicinal products on the basis of price – Special sales or combined sales including other medicinal products, also at reduced prices, or other merchandise)





I. Introduction

1. In the present case, the Latvijas Republikas Satversmes tiesa (Constitutional Court, Latvia) asks the Court to rule on the interpretation of Directive 2001/83/EC ( ) in order to clarify, in particular, whether, given the nature and extent of the harmonisation brought about by that directive, a Member State may prohibit the dissemination of information which encourages the purchase of medicinal products not only where the information relates to a specific medicinal product, but also where it relates to non-prescription medicinal products in general.

2. I delivered an initial Opinion in this case on 9 December 2021, following which the oral part of the procedure was closed.

3. On 13 January 2022, the Fourth Chamber of the Court, taking the view that the implications which the judgments in A (Advertising and sale of medicinal products online) ( ) and DocMorris ( ) could have for the answers to the questions referred for a preliminary ruling in the present case warranted the attention of a formation composed of a greater number of judges, decided to remit the present case to the Court for it to be assigned to such a formation, pursuant to Article 60(3) of its Rules of Procedure.

4. On 1 February 2022, the Court decided to reallocate the case to the Grand Chamber.

5. By order of 2 March 2022, EUROAPTIEKA, ( ) the Court (Grand Chamber) decided to reopen to oral part of the procedure and invited the interested parties referred to in Article 23 of the Statute of the Court of Justice to attend a fresh hearing.

II. Legal framework

A. EU law

6. Articles 86 to 100 of Directive 2001/83, which concern the advertising of medicinal products, appear in Titles VIII and VIIIa of that directive, which are respectively entitled ‘Advertising’ and ‘Information and advertising’.

7. Article 86(1) of the directive reads:

‘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,

…’

8. Article 87(3) of that directive stipulates, inter alia, 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’.

9. Article 90 of the same directive sets out a list of the material which the advertising of a medicinal product to the general public must not contain.

B. Latvian law

10. Subparagraph 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 on detailed rules for the advertising of medicinal products and detailed rules pursuant to which a medicinal product manufacturer may give free samples of medicinal products to medical practitioners), of 17 May 2011 (Latvijas Vēstnesis, 2011, No 78) (‘the provision at issue’), provides:

‘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. Procedure before the Court

11. In response to the invitation to the interested parties referred to in Article 23 of the Statute of the Court of Justice of the European Union, SIA ‘EUROAPTIEKA’, the Latvian Government and the European Commission answered the questions for oral reply, put to them by the Court, at the hearing on 22 March 2022. At that stage of the proceedings, the interested parties were given a second opportunity to submit their observations, this time orally, on the questions referred by the national court 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?’

IV. Analysis

12. My analysis of the first question referred for a preliminary ruling led me to consider, in essence, that any dissemination of information, canvassing or inducement designed to promote the prescription, supply, sale or consumption of medicinal products is liable to fall within the concept of ‘advertising of medicinal products’, within the meaning of Article 86(1) of Directive 2001/83, including where that information concerns not a specific medicinal product, but non-prescription medicinal products in general or, to employ the term used by the interested parties at the hearing, ‘unspecified medicinal products’. ( )

13. Moreover, in my analysis of that question, I distinguished the present case from those which gave rise to the judgment in A (Advertising and sale of medicinal products online), which was delivered five days before the order for reference in this case was adopted, and the judgment in DocMorris, which was delivered after the request for a preliminary ruling was lodged with the Court. ( )

14. Given the considerations which I set out in my first Opinion, I shall confine myself in this Opinion to examining the questions and points that were debated at the hearing.

15. In response to one question put by the Court at the hearing, EUROAPTIEKA in fact stated that it was of the opinion that Directive 2001/83 is applicable only where the advertising is aimed at promoting the sale of medicinal products and, having regard to paragraph 50 of the judgment in A (Advertising and sale of medicinal products online), only where it concerns specific medicinal products. In this connection, it submitted that the EU legislature did not, by means of Directive 2001/83, fully harmonise the rules relating to the advertising of unspecified medicinal products and that, consequently, such advertising is liable to come within the scope of Directive 2005/29/EC. ( )

16. The Latvian Government and the Commission, on the other hand, are of the opinion, in essence, that, although the Member States are not allowed to prohibit advertising entirely where it concerns non-prescription medicinal products, they must nevertheless ensure, in accordance with Directive 2001/83, that advertising measures do not encourage the irrational use of medicinal products. In so doing, a Member State must, according to the Commission, take account of the habits and customs in that Member State. On that subject, the Latvian Government has stated that the national authorities had received complaints from economic operators and consumers regarding the advertising activities of EUROAPTIEKA, which are peculiar to that company.

17. Three main issues were therefore debated at the hearing, concerning, first, whether Directive 2001/83, read in the light of paragraph 50 of the judgment in A (Advertising and sale of medicinal products online), also covers advertising for unspecified medicinal products, secondly, whether, in addition to the prohibitions relating to certain categories of medicinal products, that directive also establishes criteria relating to the content of advertisements for such medicinal products and, thirdly, whether such advertising falls not within the scope of Directive 2001/83, but solely within the scope of Directive 2005/29. ( )

A. The applicability of Directive 2001/83 to advertising for unspecified medicinal products

18. In my first Opinion, taking into consideration the unequivocal conclusions resulting from a textual, systematic and teleological interpretation of Directive 2001/83, as well as the factors which distinguish the present case from those which gave rise to the judgments in A (Advertising and sale of medicinal products online) and DocMorris, I proposed that the first question referred for a preliminary ruling should be answered in the affirmative. According to that proposal, advertising for unspecified medicinal products is equally liable to fall within the scope of Directive 2001/83. I shall therefore confine myself to making a few additional remarks which are prompted by paragraph 50 of the judgment in A (Advertising and sale of medicinal products online).

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

19. It should be noted that the Court held, 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 form [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’.

20. Although the Court thus juxtaposed advertising ‘for particular medicinal products’ and advertising ‘of online sales services relating to medicinal products’, paragraph 50 of that judgment cannot be read as meaning that, from the perspective of EU law, an advertising measure must necessarily take the form either of advertising to promote a specific medicinal product (the first category) or of advertising to promote services relating to medicinal products (the second category). Indeed, there is, in my view, a third category of advertising measures which Directive 2001/83 cannot ignore, namely advertising directly aimed at promoting the prescription, supply, sale or consumption of unspecified medicinal products. By contrast with the advertising of services (the second category), this third category of advertising falls within the scope of Directive 2001/83, just like advertising for specific medicinal products (the first category).

21. The fact that the Court did not refer, in the judgment in A (Advertising and sale of medicinal products online), to this third category of advertising measures is due to the fact that, in that case, the referring court was questioning the conformity with EU law of the prohibition of an advertising measure which the Court classified, under EU law, not as ‘advertising for products’, but ‘advertising of services’. ( )

22. Indeed, the Court observed, in paragraph 48 of the judgment in A (Advertising and sale of medicinal products online), that it was apparent from the order for reference that the service provider at issue in the main proceedings was carrying out ‘a wide-ranging and multifaceted advertising campaign for its online sales services’. ( ) It was in light of that observation that the Court considered it unnecessary to take account of Titles VIII and VIIIa of Directive 2001/83, ( ) because the provisions which make up those titles are intended to regulate the content of the advertising message and the manner of advertising for particular medicinal products, but do not govern the advertising of online sales services relating to medicinal products. ( )

23. I should point out, for the sake of completeness, that, in the case which gave rise to the judgment in A (Advertising and sale of medicinal products online), the Court considered that it was necessary to interpret EU law so that the referring court could assess the conformity with EU law of the application of national legislation in four different cases. ( )

24. However, while the Court distinguished between those four cases, it was in the part of the judgment that addressed the first case that it made the general finding that it was unnecessary to take account of Titles VIII and VIIIa of Directive 2001/83. The Court stated that that general finding was important ‘in order to answer the first part of the question’. ( ) However, that general finding is not repeated in the paragraphs of the judgment which address the remaining cases.

25. There are two possible explanations for that. Either the Court considered that only the first case contained an element of advertising, or it considered that, since that general finding applied to all cases liable to be classified as an ‘advertising measure’, it was unnecessary to repeat it.

26. That said, the fact that the judgment in A (Advertising and sale of medicinal products online) lends itself to different readings does not alter the fact that the Court began from the premiss that the (second) category of advertising measures aimed at promoting sales services relating to medicinal products does not fall within the scope of Directive 2001/83. However, it does not follow from that judgment that Directive 2001/83 does not apply to the (third) category of advertising measures aimed directly at promoting the prescription, supply, sale or consumption of unspecified medicinal products.

27. How can these two categories of advertising measures be distinguished? The judgment in DocMorris, which refers to paragraph of 50 the judgment in A (Advertising and sale of medicinal products online), makes it possible to outline each of them.

2. The judgment in DocMorris

28. It should be noted that, in the judgment in DocMorris, the Court held that an advertising campaign in the form of a prize competition allowing participants to win everyday items other than medicinal products, participation in that competition being subject to the submission of an order for a medicinal product for human use subject to a medical prescription, together with that prescription, did not fall within the scope of the provisions of Title VIII of Directive 2001/83. In so deciding, the Court noted that such an advertising campaign was not intended to influence the customer’s choice of a given medicinal product, but the choice of the pharmacy from which the customer purchases that medicinal product, that second choice being made after the first. ( )

29. Given that the advertising measure at issue in that judgment was conditional on a customer’s first obtaining a medical prescription, under the supervision of an individual authorised to prescribe the medicinal products concerned, I infer that, in the Court’s view, that advertising measure was not intended to influence the customer’s decision to purchase one or more medicinal products. Consequently, the advertising measure was not liable to encourage the irrational use of medicinal products. ( )

30. On the other hand, as Advocate General Kokott has observed in another context, while non-prescription medicinal products may be acquired at the instigation of doctors, in many cases the end users decide by themselves on their purchase, which is why they are also advertised to end users. ( ) In order to prevent the irrational use of non-prescription medicinal products, such advertising directed at consumers must fall within the scope of Directive 2001/83. I might add that, to take the view that only advertising for a specific medicinal product comes under that directive would, from a practical perspective, greatly reduce the scope ratione personae of the provisions of Titles VIII and VIIIa of that directive. Such advertising, focussing on a particular medicinal product, is in principle carried out by the undertaking which manufactures that product. In advocating an interpretation which allows for a reasonably broad application of those provisions, ratione personae, the Court nevertheless clarified that the definition of the concept of ‘advertising of medicinal products’ appearing in Article 86(1) of that directive explicitly emphasises the purpose of the message and does not provide any indication as to the people who disseminate that information. ( )

31. It follows, as I observed in my first Opinion, ( ) that an advertising measure aimed at promoting the prescription, supply, sale or consumption of unspecified medicinal products also falls within the scope of Directive 2001/83 where it is liable to influence the consumer’s decision to purchase a medicinal product and is therefore capable of encouraging the irrational use of medicinal products.

B. The harmonisation brought about by Directive 2001/83 in the field of the advertising of unspecified medicinal products

32. It is now necessary to examine the second question referred for a preliminary ruling that was debated at the hearing, which was whether, in addition to the prohibitions relating to certain categories of medicinal products, Directive 2001/83 also establishes criteria which advertisements for unspecified medicinal products must meet. In aid of that examination, it is necessary to begin by considering the extent of the positive harmonisation effected by the EU legislature by means of that directive and to then attempt to identify these criteria.

1. Positive harmonisation in the field of the advertising of unspecified medicinal products

33. Article 88(1) of Directive 2001/83 requires the Member States to prohibit the advertising to the general public of medicinal products which are available on medical prescription only and those which contain substances defined in international conventions as psychotropic or narcotic. Article 88(2) of that directive authorises the advertising to the general public of medicinal products for which no medical prescription is needed. ( )

34. It may be inferred from those two provisions that the Member States may not prohibit all advertising relating to the sale by mail order of non-prescription medicinal products. ( )

35. That being so, the question which arises is whether Directive 2001/83 simply guarantees the right to advertise non-prescription medicinal products, without laying down any criteria that the content of such advertising must meet.

36. From a dogmatic viewpoint, in the absence of rules laid down in secondary legislation, the elimination of disparities between measures adopted by the Member States is ensured by way of negative harmonisation. In so far as the free movement of goods is concerned, this entails, in particular, the prohibition of measures having equivalent effect to quantitative restrictions. ( ) While directives can impose prohibitions on the Member States, like those laid down in Article 88(1) and (2) of Directive 2001/83, they are naturally better suited to the enactment of provisions which bring about positive harmonisation. Following that logic, this directive is an instrument which should, in the normal course, have been used to lay down the criteria that must be met by any advertising permitted under it.

37. Admittedly, it could be argued that the interest in adopting a directive authorising the advertising of non-prescription medicinal products, without specifying the criteria to be met by such advertising, lay in the fact that, in the absence of such a directive, the Member States would have been free to prohibit such advertising. Indeed, as I observed in my first Opinion, ( ) a national measure which concerns both advertising for specific medicinal products and advertising for unspecified medical products may be regarded as ‘governing selling arrangements’, within the meaning of the Court’s case-law, and as satisfying the two conditions described in the Keck and Mithouard ( ) case-law, and it would therefore fall outside the scope of Article 34 TFEU. The Member States would thus remain free to prohibit all advertising of non-prescription medicinal products.

38. However, such an interpretation of the provisions of Titles VIII and VIIIa of Directive 2001/83 would run counter to the essential objective of that directive, which is not to liberalise advertising activities throughout the European Union, but to harmonise national legislation in that field, in the interests of consumers and consumer health.

39. Indeed, in the first place, as the Court has already stated, the essential aim of Directive 2001/83 is to safeguard public health. ( ) In line with that, recital 45 of the directive states that advertising to the general public, even of non-prescription medicinal products, could affect public health, were it to be excessive and ill-considered and, where it is permitted, it ought therefore to satisfy certain essential criteria which ought to be defined. Following that logic, to the extent that advertising for unspecified medicinal products is capable of resulting in the irrational use of medicines ( ) and therefore of affecting public health, Directive 2001/83 should have been designed as an instrument which defines the essential criteria that such advertising must meet.

40. In the second place, an interpretation of Directive 2001/83 according to which that directive does not define such criteria would run counter to the ratio legis of the provisions of Titles VIII and VIIIa thereof. As is apparent from recital 43 of that directive, ( ) the EU legislature sought, by means of those provisions, to eliminate the disparities resulting from the adoption of specific measures by the Member States concerning the advertising of medicinal products. In so far as such disparities existed also in relation to the advertising of unspecified medicinal products, it should be considered that the EU legislature sought to eliminate them by means of that directive.

41. In the third place, in interpreting the concept of ‘advertising of medicinal products’, the Court has held that Article 86(1) of Directive 2001/83 expresses a general rule applicable to any situation where it is necessary to determine whether an activity constitutes advertising of medicinal products. As I indicated in my first Opinion, I understand that finding to mean that, in so far as concerns the framework for the assessment of the conformity with EU law of advertising measures relating to medicinal products, the EU legislature chose to rely not on provisions of primary law, but on the provisions of Directive 2001/83. ( )

42. It follows from those considerations that Directive 2001/83 was designed as an instrument by means of which the EU legislature effected positive harmonisation also in relation to the advertising of unspecified medicinal products. It is now necessary to determine what ‘essential criteria’, to borrow the words of recital 45 of the directive, must be met by advertising for unspecified medicinal products.

2. The essential criteria relating to the advertising of unspecified medicinal products

43. In its judgment in Deutscher Apothekerverband, with reference to Article 88(2) of Directive 2001/83, which provides that ‘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’, the Court clarified that ‘in general, advertising of medicinal products intended and designed for use without the intervention of a medical practitioner is permitted, provided that certain conditions are complied with’. ( )

44. That mention of compliance with ‘certain conditions’ cannot be regarded as referring solely to possible recourse to ‘the advice of the pharmacist’, expressly mentioned in Article 88(2) of Directive 2001/83. First of all, in the judgment in Deutscher Apothekerverband, the Court held, in essence, that that provision cannot be interpreted as prohibiting advertising the sale by mail order of medicinal products on the basis of any alleged need for a pharmacist to be physically present. ( ) Secondly, recourse to ‘the advice of the pharmacist’ would constitute only one condition, whereas, in that judgment, the Court mentioned compliance with ‘certain conditions’.

45. Moreover, in its original version, Article 88(2) of Directive 2001/83 included a second subparagraph, which provided that ‘Member States shall prohibit the mentioning in advertising to the general public of therapeutic indications’. ( )

46. Admittedly, the Court did not set out that second subparagraph in the judgment in Deutscher Apothekerverband ( ) and, moreover, it was deleted by Directive 2004/27, as was the third indent under the original version of Article 88(1) of Directive 2001/83, which required the Member States also to prohibit the advertising to the general public of medicinal products which ‘may not be advertised to the general public in accordance with the second subparagraph of paragraph 2’.

47. That said, the second subparagraph of Article 88(2) of Directive 2001/83, in its original wording, seemed to reflect the notion that it was necessary to prohibit advertising which, by exaggerating a medicine’s properties, was liable to lead consumers into over-consumption or unnecessary consumption of medicinal products. That notion is conveyed by the reference to ‘certain conditions’ which the advertising of medicinal products must fulfil, to which the Court referred in the judgment in Deutscher Apothekerverband. ( ) Indeed, recital 45 of the directive mainly concerns the normative content of Article 88(2) thereof, which authorises the advertising to the general public of medicinal products for which no medical prescription is required. In that recital, the EU legislature stated that it was necessary to define the conditions (‘certain essential criteria’) that must be fulfilled by ‘advertising to the general public, even of non-prescription medicinal products’, so that it is not ‘excessive or ill-considered’ and, consequently, liable to ‘affect public health’.

48. More importantly, the idea that advertising authorised under Directive 2001/83 must fulfil certain conditions was not abandoned by the EU legislature. On the contrary, the decision to delete the third indent under Article 88(1) and the second subparagraph of Article 88(2) of the directive arose because that legislature considered it necessary for these ‘essential criteria’ to be defined other than by reference to specific cases.

49. In the same vein, the EU legislature’s intention to combat ‘excessive and ill-considered’ advertising liable to ‘affect public health’ is reflected in Article 87(3) of Directive 2001/83, which provides 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 [(first indent) and] shall not be misleading [(second indent)]’. Although, textually, that provision refers to the advertising of a medicinal product, a systematic and teleological reading of the directive suggests an interpretation according to which the requirements laid down by Article 87(3) reflect the conditions – or, in the words of recital 45 of the directive, the ‘essential criteria’ – which apply to all advertising falling within the directive’s scope, including advertising for unspecified medicinal products.

50. As regards, in the first place, the first indent under Article 87(3) of Directive 2001/83, it is of course true, as was pointed out at the hearing, that that provision states 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’.

51. Nonetheless, the Court clarified this point in its judgment in Gintec, ( ) stating that the imperative of preventing any excessive and ill-considered advertising which could affect public health, to which recital 45 of Directive 2001/83 alludes, is reflected in Article 87(3) of the directive, which provides that the advertising of medicinal products must encourage their rational use. It is not unusual that the Court did not set out the full wording of Article 87(3) when mentioning that provision. It did, however, state the essential part of the provision, and referred to is as a reflection of the ‘imperative’ which underlies the provisions of the directive. It is that imperative that obliges the Member States to prohibit any advertising that encourages the irrational use of medicinal products, including advertising for unspecified medicinal products.

52. As regards, in the second place, the second indent under Article 87(3) of Directive 2001/83, the requirement that advertising must not be misleading is echoed in Article 97 of the directive, according to which adequate and effective methods for monitoring the advertising of medicinal products will include the possibility of ordering the cessation of, or of instituting appropriate legal proceedings for an order for the cessation of misleading advertising. That provision thus provides textual confirmation of the importance of the requirement that advertising, including advertising for unspecified medicinal products, must not be misleading. That requirement thus applies, in line with the original wording of Article 88(2) of the directive and with the reference in the judgment in Deutscher Apothekerverband to compliance with ‘certain conditions’, ( ) to advertising for unspecified medicinal products.

53. It follows that Directive 2001/83 lays down at least two ‘essential criteria’ that advertising for unspecified medicinal products must meet, namely that the directive does not authorise advertising which encourages the irrational use of medicinal products and that it does not authorise misleading advertising, within the meaning of the directive.

54. The fact that these ‘essential criteria’ are defined in the abstract is due to the legal nature of Directive 2001/83. Indeed, although the directive brought about a complete harmonisation in the field of advertising for medicinal products, it left it to the Member States to determine the form and methods for applying these essential criteria and prohibiting advertising which does not meet them. The Member States are not, on the other hand, allowed to adopt provisions which deviate from the rules laid down by the directive and expressly listed. They may not, therefore, ignore these criteria and authorise any and all advertising of medicinal products.

55. In any event, the fact that certain essential criteria relating to the advertising of unspecified medicinal products are to be found in Directive 2001/83 confirms the interpretation that such advertising is liable to fall within the concept of ‘advertising of medicinal products’, within the meaning of Article 86(1) of the directive.

C. Advertising for medicinal products under Directives 2001/83 and 2005/29

56. It is now necessary to examine the argument that advertising for unspecified medicinal products falls not within the scope of Directive 2001/83, but solely within the scope of Directive 2005/29. In aid of that examination, it is necessary first to consider the implications of that view and then to consider the relationship between the two directives.

1. The implications of the view that advertising for unspecified medicinal products does not fall within the scope of Directive 2001/83

57. Directive 2005/29 defines its scope by referring, in Article 3(1) thereof, to the concept of ‘unfair business-to-consumer commercial practices’. The concept of ‘commercial practices’ is given a particularly wide definition, in Article 2(d) of that directive, as ‘any act, omission, course of conduct or representation, commercial communication including advertising and marketing, by a trader, directly connected with the promotion, sale or supply of a product to consumers’. ( ) In addition, pursuant to Article 2(c) of that directive, a ‘product’ means any goods or services.

58. It may be gleaned from the case-law that, given those broad definitions, advertising relating to dental care ( ) and the advertising of procedures relating to plastic surgery, whether through publications in advertising brochures or on the Internet, ( ) constitute ‘commercial practices’ for the purposes of Directive 2005/29.

59. Furthermore, according to that case-law, Directive 2005/29 does not preclude national legislation which protects public health and the dignity of a particular profession by imposing a general and absolute prohibition on any advertising relating to the provision of the professional services concerned. ( ) Indeed, that directive does not have the effect of calling into question national rules relating to the health and safety aspects of products, or specific provisions governing regulated professions. ( )

60. However, to the extent that such national rules concern the provision of services, Article 56 TFEU is liable to preclude them for the reason that they constitute restrictions on the freedom to provide services. ( ) It is therefore possible to prevent Member States from adopting a general and absolute prohibition on all advertising for such services.

61. It is certainly true that, given the broad definitions which Directive 2005/29 employs to determine its scope, both advertising for a specific medicinal product and advertising for unspecified medicinal products are liable to constitute ‘commercial practices’ for the purposes of that directive. However, to accept the view that advertising for unspecified medicinal products falls within the scope not of Directive 2001/83, but of Directive 2005/29 would enable the Member States to prohibit such advertising, regardless of whether or not it constitutes an unfair commercial practice. Indeed, by contrast with the advertising of services, national provisions relating to the advertising of products such as medicines fall outside the scope of Article 34 TFEU. ( ) Directive 2005/29 is therefore not the appropriate framework for ensuring the harmonisation of national provisions relating to the advertising of medicinal products.

2. The relationship between Directives 2001/83 and 2005/29

62. The fact that Directive 2005/29 tends to give precedence to the application of more specific instruments of EU law is an important factor in the present case.

63. In that connection, it is plain from Article 3(3) of Directive 2005/29 that that directive is without prejudice to rules of EU law or national rules relating to the health and safety aspects of products. Similarly, the directive provides, in Article 3(4) thereof, that, in the event of conflict between its provisions and other rules of EU law regulating specific aspects of unfair commercial practices, the latter are to prevail and apply to those specific aspects.

64. To the extent that the argument that advertising for a specific medicinal product falls within the scope of Directive 2001/83, while advertising for unspecified medicinal products falls only within the scope of Directive 2005/29 is based on Article 3(3) and (4) of the latter directive, it is hard to reconcile it with a systematic interpretation of that latter directive.

65. Indeed, in so far as advertising measures are concerned, Directive 2005/29 draws no distinction between advertising for a specific medicinal product and advertising for unspecified medicinal products.

66. Directive 2005/29 in fact prohibits, inter alia, unfair commercial practices which are misleading, within the meaning of Articles 6 and 7 thereof. ( ) Pursuant to Article 7(1) and (2) of that directive, ‘a commercial practice shall be regarded as misleading if … it omits material information that the average consumer needs [or where it] hides or provides in an unclear, unintelligible, ambiguous or untimely manner such material information … or fails to identify the commercial intent of the commercial practice if not already apparent from the context’.

67. Pursuant to Article 7(5) of Directive 2005/29, ‘information requirements established by [EU] law in relation to commercial communication including advertising or marketing, a non-exhaustive list of which is contained in Annex II, shall be regarded as material.’ That annex refers to provisions of Directive 2001/83. That reference points not only to provisions of Directive 2001/83 such as Article 89 thereof, which, textually at least, concerns the advertising of medicinal products and the content of such advertising, but also to Articles 86 to 100 of the directive. This confirms the fact that, also from the perspective of Directive 2005/29, both advertising for a specific medicinal product and advertising for unspecified medicinal products fall within the scope of Directive 2001/83.

V. Conclusion

68. In light of all of the foregoing considerations and the analysis which I set out in my first Opinion in that case (C‑530/20, EU:C:2021:993), the reply I suggested to the questions referred for a preliminary ruling by the Latvijas Republikas Satversmes tiesa (Constitutional Court, Latvia), set out in point 91 of my first Opinion, remains the same.