CJEU rules on advertising restrictions for medicinal products

Background

On 22 December 2022, the Court of Justice of the European Union (CJEU) rendered a decision in case C-530/20 “Euroaptieka” (the Case) following a request for a preliminary ruling from the Latvijas Republikas Satversmes tiesa, the Latvian Constitutional Court.

The request from the Latvian Constitutional Court was made in the framework of a case brought by Euroaptieka, a company which engages in the sale of medicinal products to patients in Latvia.

In March 2016, the company had been announcing a 15% discount for any purchase of at least three items on its website or in its periodical magazine. The next month, the Latvian government prohibited the announcement on grounds of a provision of national law which bans the advertising of medicinal products (that are neither prescribed nor reimbursed) on the basis of price, special sales or bundled sales of medicinal products and other products (the Latvian Provision).

In January 2020, Euroaptieka appealed the Latvian government’s decision to the Latvian Constitutional Court. There, the company argued:

• that the Latvian Provision breached EU law in so far as it applies to advertising made for a specific medicinal product, but also to advertising made for medicinal products in general where EU law provisions, which the Latvian provision implements, apply only to the advertising of specific medicinal products and not to the advertising of medicinal products in general;
• that the Latvian Provision breached EU law in so far as it prohibits advertising materials which are not listed under Article 90 of the Directive 2001/83/EC of 6 November 2001 on the Community Code relating to medicinal products for human use (the Directive), even though the Directive provides for full harmonization and that Member States may not enact additional rules pertaining to its subject-matter.

Bearing this in mind, Euroaptieka argued that the Latvian government went beyond what the Directive lays down and thus breached EU law.

Questions

Faced with this issue, the Latvian Constitutional Court decided to request a preliminary ruling from the CJEU and asked the three following questions:

• Must the advertising of medicinal products on the basis of price, special sales or bundled sales of medicinal products and other products be regarded as advertising of medicinal products in the meaning of Article 86(1) of the Directive?
• Must Article 90 of the Directive be interpreted as precluding national rules which extend the list of prohibited methods of advertising for medicinal products and impose stricter restrictions than those provided for in that Article?
• Must the Latvian Provision at issue 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 the Directive?

Ruling

In short, the CJEU answered yes, yes, and yes.

1. At the outset, the CJEU clarified that the definition of “advertising of medicinal products” under Article 86(1) of the Directive does, in fact, include not only advertising made for a specific medicinal product but also advertising made for medicinal products in general (para. 27 to 51).

   To that end, the CJEU examined the wording of Article 86(1), the context in which it stands and the general purpose of the Directive, i.e. that of safeguarding public health. It also distinguished the case from two precedents which had led scholars to believe that Article 86(1) of the Directive did not apply to general advertising.

   In that regard, if the CJEU’s analysis may not be regarded as a departure from previous case law, it may certainly be understood as an important development and clarification of the scope of “advertising of medicinal products” in the meaning of the Directive.

2. On the second question referred by the Latvian Constitutional Court, the CJEU ruled, that Member States do not go beyond what the Directive lays down when they prohibit certain advertising materials, even if those materials are not referred to under Article 90 of the Directive, provided that:

   • They provided that they do so to encourage the “rational use” of medicinal products in the meaning of Article 87(3); and
   • Pursue the objectives of the Directive, i.e. safeguarding public health and preventing excessive and ill-considered advertising¹

3. Then, to answer the third question, the CJEU looked into the Latvian Provision itself and found that it concerned medicinal products which are neither subject to prescription nor reimbursement and that as a result, it is “the end consumer himself or herself evaluates, without the assistance of a doctor, the usefulness or need to purchase such medicinal products.”

In view of that assessment, the CJEU recalled that it had already judged that “[a]dvertising that distracts the consumer from an objective evaluation of the need to take such medicine encourages the irrational and excessive use of that medicinal product”² and that based on the information it consulted, it was clear that “[the Latvian Provision] merely prohibits advertising of promotional offers or bundled sales and advertising on the basis of price, without prejudice to the possibility, […] for undertakings that trade in medicinal products[,] to grant discounts and price reductions when selling medicinal products and other health products.”

Therefore, the CJEU decided that the Latvian Provision did not breach EU law.

Key Takeaways

• the CJEU clarified that “advertising of medicinal products”, under Article 86(1) of the Directive, includes advertising made for specific medicinal products as well as advertising made for medicinal products in general (in doing so, it clarified its previous decisions); and
• the CJEU ruled that Member States may ban certain advertising materials which are not listed under Article 90 of the Directive, provided that they do so to encourage the “rational use” of medicinal products in the meaning of Article 87(3) and pursue the objectives of the Directive, ie safeguarding public health and preventing excessive and ill-considered advertising.

¹ See cases C-649/18 of 1 October 2020, A, EU:C:2020:764 and C-190/20 of 15 July 2021, Doc Morris, ECLI:EU:C:2021:609
² See C-374/05 of 8 November 2007, Gintec, EU:C:2007:654, para. 56.