Opinion of Advocate General Szpunar delivered on 9 June 2022.

• Jurisdiction: European Union
• ECLI: ECLI:EU:C:2022:450
• Date: 09 June 2022
• Celex Number: 62020CC0530(01)
• Court: Court of Justice (European Union)

Provisional text

ADDITIONAL OPINION OF ADVOCATE GENERAL

SZPUNAR

delivered on 9 June 2022 (1)

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 (2) 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) (3) and DocMorris (4) 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, (5) 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’. (6)

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. (7)

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. (8)

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. (9)

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...