In its ruling of 17 July 2025, the Federal Court of Justice (BGH) announced its decision in the so-called "Rx bonus" case. The dispute was about whether advertising and granting bonuses on prescription medicinal products (Rx medicinal products) constituted an anti-competitive violation of German medicinal product pricing regulations. In particular, it was in dispute whether the drug pricing regulations were even applicable to the defendant mail-order pharmacy, which is based in another EU country. The BGH ruled that this was not the case, stating that the German drug pricing regulations violated the free movement of goods (Art. 34 TFEU). In contrast to the previous instance, the BGH did not consider the violation of the free movement of goods to be justified under Art. 36 TFEU and therefore concluded that the German drug pricing regulations were not applicable to the defendant mail-order pharmacy based in another EU country. Although Section 78 para. 1 sentence 4 of the German Medicines Act (AMG) (old version), on which the BGH's decision was based, has since been repealed by the German legislature, Section 129 para. 3 sentences 2 and 3 of the German Social Code, Book V (SGB V) contains a new provision with comparable content, raising the question of whether comparable standards apply in this respect. However, the BGH explicitly left this open in its decision.
Facts
The defendant, a mail-order pharmacy based in the Netherlands, dispensed prescription medicinal products to patients residing in Germany. The defendant advertised that patients would receive a bonus of EUR 3.00 per medicinal product (up to a total of EUR 9.00 per prescription) when they redeemed a prescription. . It also advertised that patients would receive a bonus of up to EUR 9.00 when redeeming a prescription if they carried out a "medication check", i.e. a check for incompatibilities and interactions. In both cases, the invoice amount was offset against the so-called "Rx bonus". The plaintiff, a pharmacists' association, considered this practice to be inadmissible and brought an action against the mail-order pharmacy advertising the Rx bonuses.
The ruling of the BGH was preceded by rulings of the Munich I Regional Court (LG Munich I) on 13 March 2014 (Ref. 11 HK O 12091/13) and the Munich Higher Regional Court (OLG Munich) on 7 March 2024 (Ref. 6 U 1509/14), which had both upheld the pharmacists' association's claim (we reported on this previously). Irrespective of these two proceedings, on 19 October 2016, the Court of Justice of the European Union (CJEU) issued a preliminary ruling in another case on the question of the applicability of national price regulations to mail-order pharmacies based in the European Union (CJEU, GRUR 2016, 1312 – Deutsche Parkinson Vereinigung). The ECJ ruled that national price fixing regulations for prescription medicinal products may, under certain conditions, violate the free movement of goods under Articles 34 and 36 TFEU. Despite this ruling, however, the OLG Munich denied that the German price regulations were contrary to EU law, arguing that in the "Deutsche Parkinson Vereinigung" case decided by the ECJ, the requirements for justification under Article 36 TFEU had not been sufficiently substantiated. This distinguished the ECJ proceedings from the proceedings to be decided by the OLG Munich, as sufficient substantiation for justification had, in the opinion of the OLG Munich, been provided in those proceedings.
Decision of the BGH
In its decision, the BGH (initially in agreement with the lower court, the OLG Munich) clarified that the Rx bonuses granted by the defendant mail-order pharmacy as a direct discount on the pharmacy retail price were fundamentally contrary to German drug pricing law, namely against Section 78 para. 1 sentence 4 AMG (old version), which was applicable during the period in dispute. However, in contrast to the opinion of the OLG Munich, the BGH did not consider this to be anti-competitive behaviour. The BGH justified this on the grounds that the German regulations on fixed drug prices were contrary to EU law due to a violation of the free movement of goods (Art. 34 TFEU) and were therefore not applicable to the defendant, which is based in another Member State of the European Union. The fixed prices for medicinal products constituted a measure having an effect equivalent to a quantitative restriction on imports within the meaning of Article 34 TFEU, which could at best be justified by the protection of human health and life under Article 36 TFEU. Contrary to the opinion of the OLG Munich, the BGH rejected such a justification under Art. 36 TFEU with the reasoning that this had not been substantiated. In the opinion of the BGH, the plaintiff pharmacists' association had failed to substantiate sufficiently that without fixed drug prices, the maintenance of a safe and comprehensive supply of drugs and therefore the health of the population would be endangered. To this end, empirical data on the effects of uniform pharmacy prices on the comprehensive, secure and high-quality supply of medicinal products to the population would have had to be collected, but the plaintiff had failed to do so and had therefore not presented sufficient evidence in this regard. Furthermore, some of the expert opinions submitted by the plaintiff to demonstrate the justification requirements of Article 36 TFEU did not even relate to the period in dispute and were therefore also unsuitable for substantiating the plaintiff's submission.
As a result, the Federal Court of Justice denied justification under Article 36 TFEU, meaning that the drug price regulations at issue are not compatible with the free movement of goods under Article 34 TFEU, in accordance with the ECJ ruling in the ‘Deutsche Parkinson Vereinigung’ case. Consequently, the defendant mail-order pharmacy was not required to comply with these provisions, meaning that the Rx bonuses granted did not constitute a violation of competition law.
Conclusion
With its latest ruling, the BGH has provided more clarity for mail-order pharmacies operating across borders. Although the ruling refers to Section 78 para. 1 sentence 4 AMG (old version), which has since been repealed, the BGH's ruling that restrictions on the free movement of goods resulting from German drug pricing law cannot be justified without good reason should be taken into account. In this context, the Federal Court of Justice expressly emphasises that strict requirements must be imposed on the substantiation requirements in the context of the presentation of justifications pursuant to Art. 36 TFEU, thereby strengthening the legal position of mail-order pharmacies operating across borders. However, it should be noted that the prohibition on granting benefits in Section 7 of the German Drug Advertising Act (HWG) continues to apply in principle (see Federal Court of Justice, judgment of 18 November 2021, ref. I ZR 214/18 – Gewinnspielwerbung II). Only in the case of price reductions on prescription medicinal products it can be argued that benefits are permissible, as in the case of non-prescription medicinal products, due to the incompatibility of German drug price regulations with EU law. Otherwise, Section 7 HWG applies without restriction, in particular to gifts or other monetary benefits to consumers that are not price reductions.
Furthermore, it cannot be ruled out that the BGH could accept a justification (pursuant to Art. 36 TFEU) in future proceedings involving comparable circumstances. In the past, it had itself emphasised that the ECJ's assessment in the ‘Deutsche Parkinson Vereinigung’ decision was based largely on insufficient factual findings by the referring court (see BGH, judgment of 18 November 2021, ref. I ZR 214/18 – Gewinnspielwerbung II). In the opinion of the BGH, it therefore cannot be ruled out that these factual findings will be substantiated in other proceedings in which the compatibility of German drug pricing law with primary European Union law is at issue. In the opinion of the BGH, the parties must present evidence of the suitability of the German regulation on fixed prices for medicinal products for a comprehensive and uniform supply of medicinal products, which may justify a violation of the free movement of goods (see BGH, GRUR 2020, 550 marginal no. 20 – Sofort-Bonus II).
Finally, it remains to be seen how case law will develop with regard to Section 129 para. 3 sentences 2 and 3 SGB V. Section 129 para. 3 sentence 3 SGB V stipulates that German price ranges according to the AMPreisV are binding for pharmacies bound by framework agreements. However, according to Section 129 para. 3 sentence 2 SGB V, pharmacies may only dispense prescribed medicinal products to insured persons of the statutory health insurance fund (GKV) as benefits in kind and may only bill the health insurance funds directly if the framework agreement has legal effect for them. This results in price regulation limited to the statutory health insurance system, even for pharmacies based in other EU member states. It remains to be seen whether this GKV-specific price fixing – in contrast to the previously generally applicable provision of Section 78 para. 1 sentence 4 AMG (old version) – can be justified under EU law by the GKV's principle of benefits in kind and solidarity (cf. the relevant explanatory memorandum, BT-Drs. Drucksache 19/21732, p. 20 ff.). The BGH has expressly left this open in its current "Rx-Boni" decision.
