Immediate discounts or monetary rewards for prescriptions don't fall under Directive 2001/83 and aren't considered "advertising of medicinal products"
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SubscribeOn February 27, 2025, the Court of Justice of the European Union (CJEU) delivered a significant judgment concerning the interpretation of Directive 2001/83 of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (the "Directive 2001/83") regarding the advertising of medicinal products, particularly those subject to prescription. The case, Apothekerkammer Nordrhein v. DocMorris NV (C-517/23, ECLI:EU:C:2025:122), delves into the restrictions imposed on the advertising of prescription medicinal products and their impact on the free movement of goods and consumer protection.
For the purposes of this analysis:
Article 86(1) of that Directive provides: 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,
- (…).
Article 87(3) of the Directive provides: The advertising of a medicinal product:
- shall encourage the rational use of the medicinal product, by presenting it objectively and without exaggerating its properties,
- shall not be misleading.
For understanding this judgment, it is important to note that the German Law on the advertising of medicinal products, prohibits promotional gifts and other incentives for offered to healthcare professionals, except under certain conditions. It aims to prevent undue influence and promote the rational use of medicines.
Background
The case originated from a dispute between the Apothekerkammer Nordrhein (Pharmacists’ Chamber of North Rhine, Germany) and DocMorris NV, a Dutch company operating a mail-order pharmacy. DocMorris NV had engaged in various advertising activities promoting the purchase of prescription medicines, which the Pharmacists’ Chamber argued violated German regulations for such medicines.
Such promotional activities included:
- offering monetary rewards for sending in prescriptions;
- implementing a referral system where customers could earn vouchers for hotel stays and discounted memberships in exchange for referring friends who sent in prescriptions;
- providing immediate discounts on the purchase of prescription medicinal products; and
- providing a voucher to be used for the subsequent purchase of non-prescription medicinal products or health and care products.
The Regional Court of Cologne issued provisional injunctions to cease these advertising activities, leading DocMorris NV to seek damages, claiming the measures were unfounded. Afterwards, following a ruling by the CJEU in a related case (Deutsche Parkinson Vereinigung, C-148/15, ECLI:EU:C:2016:776), the Cologne Court annulled most of these provisional injunctions, prompting DocMorris to seek damages for the losses incurred due to such provisional injunctions. The case escalated until it reached the Federal Court of Justice (Bundesgerichtshof) in Germany, which, due to doubts regarding the interpretation of Directive 2001/83, decided to refer questions to the CJEU regarding the following:
- The concept of "advertising of medicinal products".
- The compatibility of the directive with a national rule that prohibits the advertising of the entire range of prescription medicinal products of a mail-order pharmacy using promotional gifts in the form of vouchers for a monetary amount or a percentage discount for subsequent purchases of other products.
- The compatibility of the directive with a national rule that permits the advertising of the entire range of prescription medicinal products of a mail-order pharmacy using promotional gifts in the form of immediately effective price reductions and payments?
Regarding the first and third question
The CJEU noted that Directive 2001/83 defines advertising broadly, encompassing any form of informative canvassing, or inducement activity intended to promote the prescription, supply, sale, or consumption of medicinal products. The Court further emphasized that this definition is an autonomous concept of EU law, requiring uniform interpretation across Member States.
As the Court had previously held in judgment C-530/20 (ECLI:EU:C:2022:1014) the difference between "advertising of medicinal products" and mere information relies on the purpose of the message. If the purpose is to influence the prescription, supply, sale, or consumption of medicinal products, such a message will be considered advertising of medicinal products. On the other hand if the message seeks to influence not the customer’s choice of a given medicinal product but the choice, taken at a later stage, of the pharmacy from which that customer would purchase that medicinal product, it will be considered mere information. The former falls within the scope of the aforementioned directive, while the latter does not.
The Court concluded that:
- Advertising practices offering immediate discounts or monetary rewards (cases (i) and (iii)) for sending in prescriptions did not promote specific medicinal products and were therefore not covered by Directive 2001/83.
As mentioned by the Advocate General in his opinion, when the patient receives a medical prescription, the only choice that remains to be made, with regard to the prescription-only medicinal product, is that of the pharmacy from which he or she will buy that medicinal product.
- Advertising activities that include vouchers for the purchase of non-prescription medicines or other products (cases (ii) and (iv) above ) do fall within the scope of Directive 2001/83. These activities promote the consumption of medicinal products, for the economic advantage they offer, thereby qualifying as advertising under Article 86(1).
Additionally, given that the concept of "advertising of medicinal products" covers "advertising products to the general public", the messages that offer vouchers directed to a third party through a referral scheme, would also fall within the scope of the Directive.
In addition to the interpretation of Directive 2001/83, the CJEU also considered the implications of the Treaty on the Functioning of the European Union and Directive 2000/31 (the e-commerce Directive). The Court found that national measures restricting advertising for the protection of consumers are justified under both regulations, provided they are necessary and proportionate to achieve the intended public health objectives.
Finally, the CJEU considers that the third question does not need to be answered as per the explanation in the first question.
Regarding the second question
The second preliminary question addresses whether national legislation prohibiting advertising activities that offer vouchers for subsequent purchases of other products, including non-prescription medicines, is compatible with Article 87(3) of Directive 2001/83.
Article 87(3) of Directive 2001/83 requires that advertising must encourage the rational use of medicinal products. This entails presenting the products objectively and without exaggerating their properties.
The CJEU underscores the importance of preventing excessive and imprudent advertising that could harm public health.
The Court notes that of Directive 2001/83 allows for the advertising of non-prescription medicines to the public, provided it meets certain criteria, including the requirement to promote rational use and avoid misleading information. However, the Court also acknowledges that the German prohibition on promotional gifts serves a legitimate public health objective. By preventing the use of incentives the German regulation aims to avoid the risk of irrational and excessive use of medicines. This aligns with the of Directive 2001/83's overarching goal of safeguarding public health.
Finally, the CJEU emphasizes that while the of Directive 2001/83 harmonizes certain aspects of medicinal product advertising, it does not preclude Member States from adopting stricter measures to protect public health.
Conclusion
The judgment provides a comprehensive interpretation of the provisions of Directive 2001/83 concerning the advertising of medicinal products. Whilst clarifying the scope of the term "advertising of medicinal products", emphasizing its distinction with the advertising that merely influences the choice of pharmacy, the judgment has also significant implications for the pharmaceutical industry, regulatory authorities, and consumers, as it clarifies the boundaries of permissible advertising practices and reinforces the overarching goal of safeguarding public health.
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