On 27 February 2025, the Court of Justice of the European Union (the “CJEU”) issued its judgment in case C‑517/23 between the Professional Association of Pharmacists of the North Rhine region, Germany (“Apothekerkammer Nordrhein”) and DocMorris NV, concerning the scope of Directive 2001/83/EC of the European Parliament (“Medicines Directive”) with regards to advertising measures. The decision centers on the questions referred to the CJEU by the German Federal Court of Justice (“BGH”) relating to the scope of Article 86 (1) and the interpretation of Article 87 (3) of the Medicines Directive.

Key takeaways

The decision of the CJEU is an important signal for consumer protection as it emphasized the need to combat all advertising measures that could create a risk of undue influence on the consumer and thus lead to critical self-medication, overconsumption and misuse of therapeutic products, which may be dangerous to health. The decision provides clarity on the permissible scope of advertising practices for prescription-only medicinal products by balancing the interests of pharmacies and consumers, since it allows for competitive advertising while maintaining strict consumer protection standards. On the one hand, pharmacies are allowed to use vouchers and price reductions to promote prescription-only medicinal products, which enables them to adopt more competitive marketing strategies, potentially increasing their customer base and sales. On the other hand, the decision enhances consumer protection by ensuring that advertising practices do not compromise the safety and efficacy of medicinal products. Further, the decision ensures a consistent approach to the promotion of medicinal products by harmonizing the advertising regulations across EU Member States.

Background

DocMorris operates a mail-order pharmacy established in the Netherlands that supplies prescription and non-prescription medicinal products to customers in Germany. Since 2021, it has launched various advertising campaigns promoting the purchase of prescription-only medicinal products. The Professional Association of Pharmacists of the North Rhine region considered these campaigns to be in violation of the fixed-price system that applies to prescription-only medicinal products under German law. The advertising campaigns in question comprise vouchers for the subsequent purchase of other products, such as non-prescription medicinal products and health and personal care products as well as price reductions and immediate payments.

National proceedings

Between 2013 and 2015, the Professional Association of Pharmacists of the North Rhine region secured several interim measures from the Regional Court Cologne (“Landgericht Köln”) to halt the advertising campaigns in question. Some of these measures were partially revoked by the Regional Court Cologne in 2017. DocMorris brought an action for damages against the Professional Association of Pharmacists of the North Rhine region, which was initially dismissed by the Regional Court Düsseldorf (“Landgericht Düsseldorf”). After the Higher Regional Court Düsseldorf (“Oberlandesgericht Düsseldorf”) partially granted the claim on appeal, the Professional Association of Pharmacists of the North Rhine region brought an action for judicial review before the German Federal Court of Justice (“Bundesgerichtshof”) claiming that the application for damages should be dismissed in its entirety. The German Federal Court of Justice noted that part of the advertising claims of DocMorris were unlawful under the German Act on Advertising in the Field of Healthcare (“Heilmittelwerbegesetz – HWG”). To ensure that the relevant provisions of the HWG are interpreted in conformity with the Medicines Directive, the German Federal Court of Justice has stayed the proceeding and referred three questions to the CJEU for a preliminary ruling.

The referring court asks whether advertising for the purchase of prescription medicinal products from the entire range of products of a pharmacy fall within the term of “advertising of medicinal products” of Article 86 of the Medicines Directive and therefore within the scope of the rules on the advertising of medicinal products in the Medicines Directive (Question 1). In the event, that the first referred question is to be answered in the affirmative, the referring court also asks whether Article 87 (3) of the Medicines Directive precludes an interpretation of national legislation that bans advertising measures promoting the purchase of prescription-only medicinal products through promotional gifts, such as vouchers for the subsequent purchase of other products (Question 2), while allowing advertising measures in the form of immediate price reductions and payments (Question 3).

CJEU’s decision

The CJEU held that the term "advertising of medicinal products" in Article 86 (1) of the Medicines Directive is to be interpreted broadly and in a uniform manner throughout the territory of the European Union. The decisive factor for distinguishing advertising from mere information and the fundamental defining characteristic of “advertising of medicinal products” within the meaning of Art. 86 (1) of the Medicines Directive shall be the purpose of the message. If the message is designed to promote the prescription, supply, sale or consumption of medicinal products, it is classified as advertising. By contrast, an advertising campaign does not fall within the concept of “advertising of medicinal products” if its purpose is not to influence the customer's choice of a particular medicinal product but rather to influence the choice, at a later stage, of the pharmacy from which that customer would purchase that medicinal product.

Accordingly, the CJEU ruled that the concept of “advertising of medicinal products” within the meaning of Art. 86 (1) of the Medicines Directive does not cover advertising measures that promote the purchase of unspecified prescription-only medicinal products by offering price reductions and payments. Such campaigns cannot promote the prescription or consumption of prescription-only medications, as the decision to prescribe is solely the physician's responsibility. Physicians must objectively decide on the prescription of a medicinal product. The customer's choice regarding prescription-only medications is limited to selecting the pharmacy from which they will purchase the prescribed product.

However, the concept of “advertising of medicinal products” within the meaning of Art. 86 (1) of the Medicines Directive covers advertising measures that promote the purchase of unspecified prescription-only medicinal products by offering promotional gifts in the form of vouchers for the subsequent purchase of non-prescription medicinal products. Such campaigns encourage the purchase of non-medicinal products. Further, this finding cannot be called into question by the fact that these vouchers may also be used for the purchase of goods other than non-prescription medicinal products. Otherwise, the essential aim of the Medicines Directive to safeguard public health would be greatly compromised. 

Further, the CJEU held that Article 87 (3) of the Medicines Directive must be interpreted as not precluding national legislation which prohibits advertising measures that promote the purchase of unspecified prescription-only medicinal products by offering promotional gifts in the form of vouchers corresponding to a certain sum of money or a percentage reduction for the subsequent purchase of other products, such as non-prescription medicinal products.

Although advertising of non-prescription medicinal products is generally permitted under the Medicines Directive, Member States must prohibit that such advertising includes material which is promoting the irrational use of such medicinal products to prevent risks to public health in accordance with the essential aim of the Medicines Directive to safeguard public health. This is the case if customers are granted promotional gifts in the form of vouchers corresponding to a certain sum of money or a percentage reduction which can be used to obtain from the entire range of products of a pharmacy (with the exception of prescription-only medicinal products). In such cases, the equivalent treatment of non-prescription medicinal products and other consumer products is liable to lead to the irrational and excessive use of non-prescription medicinal products, since the consumer may be distracted from an objective evaluation of the need to take those medicinal products, thus encouraging inappropriate and excessive use.