Federal Court to Rule on Prescription Drug Pricing Regulations

The Federal Court of Justice (BGH) in Germany is currently deliberating on the legality of prescription drug bonuses (Rx-boni) as part of ongoing discussions regarding pharmaceutical pricing regulations. The case stems from a dispute involving the now-defunct Rx-bonus model implemented by Wellsana, a former subsidiary of Doc Morris, during 2012 and 2013. This model allowed patients to receive direct bonuses of 3 euros per medication, up to a maximum of 9 euros per prescription, alongside an additional bonus for participating in medication reviews.

The Bavarian Pharmacists' Association (BAV) argues that these bonuses violate existing regulations on fixed drug pricing. In earlier proceedings, the Munich District Court ruled in favor of the BAV, a decision that was upheld by the Higher Regional Court of Munich. Following these rulings, Doc Morris appealed to the BGH.

During today's session in Karlsruhe, the presiding judge emphasized the need to assess the case based on previous legal frameworks, specifically addressing the prohibition of such bonuses under the Medicines Act (AMG). This prohibition was declared invalid by the European Court of Justice (ECJ) in 2016, particularly concerning cross-border trade involving foreign suppliers. In response, the German legislature transferred the ban to the Social Code. However, the current proceedings do not focus on this new regulation under Section 129 of the Social Code.

The Higher Regional Court of Munich had previously determined that Rx-boni constituted a direct price reduction against the official pharmacy retail price, thus violating both the Act Against Unfair Competition (UWG) and Section 78 of the AMG. The court's rationale indicated that the pricing regulations were not in conflict with EU laws pertaining to the free movement of goods.

In light of the ECJ's 2016 ruling, which found the justification for Germany's drug pricing to be inadequately established, the Munich court noted that the government had since provided a rationale that deemed the pricing regulations appropriate and proportionate, ultimately falling within the broad discretion of the legislature.

At today's hearing, the BGH justices discussed whether the government's justification sufficiently supports the ban on bonuses. They highlighted the necessity for empirical evidence to demonstrate how pricing competition impacts pharmacy density and, consequently, the supply of medications.

A verdict will not be announced today; however, the BGH is expected to schedule a date for the announcement of its decision. Both parties have expressed a desire for the court to also address the implications of the new regulation under the Social Code in its ruling.