On 27 February 2025, upon a request for preliminary reference, the Court of Justice of the European Union (CJEU) provided an important guidance[1] on what does and what does not constitute “advertising of medicinal products” under 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 (“Directive“). This latest CJEU guidance is of use in Serbia, Montenegro, Bosnia and Herzegovina and North Macedonia as well, since all these Western Balkans countries have harmonized their national laws with the definition of “advertising of medicinal products” from the Directive.
The reference arose from a German court case involving marketing campaigns of DocMorris NV, a Dutch mail-order pharmacy which supplies prescription and non-prescription medicines to customers in Germany. DocMorris had various advertising campaigns to promote the purchase of prescription-only medicinal products in its pharmacies. Some of those disputed campaigns involved the following schemes:
- direct payments in the form of rewards between EUR 2.50 and EUR 20 to customers who purchase any prescription-based medicine in the pharmacy and participate in a medical consultation;
- a referral scheme under which a person who refers a friend to purchase a prescription-based medicine in the pharmacy receives a hotel voucher worth approximately EUR 150 or a discounted membership to the German automobile club, while the referred friend receives a EUR 5 voucher to buy a non-prescription medicine or another non-medicinal product sold in the pharmacy;
- a rebate campaign, offering an immediate EUR 10 or EUR 5 discount for purchase of a prescription medicine in the pharmacy;
- a EUR 10 voucher to buy non-prescription medicines or health and care products in the pharmacy to a customer who buys a prescription-based medicinal product in the pharmacy.
None of the benefits offered in the campaigns were conditioned by the purchase of a particular prescription-based medicinal product. Rather, all benefits were offered in relation to the purchase of any prescription-based product available in a DocMorris pharmacy.
The Professional Association of Pharmacists nevertheless challenged the campaigns in German courts. The German Federal Court of Justice referred, inter alia, the following question to the CJEU for a preliminary ruling:
Whether advertising for the purchase of prescription medicines from a pharmacy’s full range of products can be considered as “advertising of medicinal products” under the Directive.
The CJEU had reaffirmed that the decisive factor in determining whether a communication qualifies as advertising of medicinal products is its purpose. If the primary aim of a campaign is to promote the prescription, supply, sale, or consumption of medicinal products, the campaign falls within the scope of the general prohibition of advertising from Article 86(1) of the Directive. In contrast, an advertising campaign which only seeks to influence the customer’s choice of a pharmacy in which to buy a medicinal product, does not come within the concept of “advertising of medicinal products”.
In the case at hand, the question was whether the campaigns promoting the purchase of prescription-only medicinal products from a pharmacy’s entire product range amount to advertising of medicinal products or merely to the promotion of a specific pharmacy. The CJEU concluded that an advertising message limited to unspecified prescription-only medicinal products does not amount to “advertising of medicinal products”. Such campaign cannot be considered to promote prescription or consumption of unspecified prescription-only medicinal products, because the customer cannot come into the position to consume a prescription-based product without a licensed medical doctor issuing him or her a prescription first.
As the Advocate General observed in his Opinion, when the patient receives a prescription for a particular medicinal product, an advertising message does not affect the patient’s choice to buy or not to buy a medicinal product. The only choice the patient has is related to the pharmacy in which to buy that product. Consequently, an advertising campaign involving a payment to the customer solely in relation to the purchase of prescription-only medicines is a campaign for the pharmacy and not for the medicines, and it falls outside of the Directive. This is so not only when the customer receives a discount on the invoice for a prescription-based medicine but also when he or she receives a direct award of a sum from the pharmacy in exchange for buying a prescription-based medicine there, because the direct payment of an amount to the customer does not encourage any specific purchase[2].
In contrast, an advertising campaign that includes a voucher that can be spent on non-prescription medicines (or that gives the customer a choice to use it for non-prescription medicines or other non-medicinal products sold in the pharmacy) encourages the purchase of non-prescription medicines and thus represents “advertising of medicinal products” within the meaning of the Directive.
[1] Case C-517/23 – Apothekerkammer Nordrhein
[2] In the case at hand, direct payment of EUR 2.50 to EUR 20 for submission of a prescription and participation in a medication check was unlawful under German law not based on the Directive but because the award was advertised as a range and not as an exact amount.
