European body awards a €10 million grant to the specified recipient
In a landmark ruling, the Federal Court of Justice (BGH) in Karlsruhe has determined that the rules on drug pricing in Germany do not apply to mail-order pharmacies based in other EU countries. The ruling, which was handed down in January 2025, has sparked debate and confusion in the pharmaceutical market, as the exact details of the decision regarding drug pricing regulations for cross-border mail-order pharmacies within the EU versus those based in Germany are not readily available.
The ruling specifically addresses the rules on drug pricing for mail-order pharmacies based in other EU countries compared to German mail-order pharmacies. However, a search of available court decisions and analyses does not provide explicit details on changes in the legal framework for mail-order pharmacy drug pricing following the BGH's judgments in 2024 and 2025.
In general, shipping prescription drugs across EU countries is regulated by EU directives. However, pricing and reimbursement can still be influenced by national laws. German mail-order pharmacies must comply with German pricing and pharmacy laws, while pharmacies based in other EU countries may legally ship medicines into Germany but may face restrictions or differences in how prices are set or reimbursed under German social health insurance law.
The BGH ruling could have clarified or reaffirmed these points, but the exact details are not retrievable from the search data currently provided. If you require the precise legal interpretation or the detailed impact of the BGH ruling of January 2025 on this matter, you may need to consult the full judgment text or specialized legal commentaries on the ruling X ZR 1/23 or related cases reported around that date.
Meanwhile, the average out-of-pocket cost per pack of prescription medications has increased by 10% since 2019 to 3.30 euros. The European Court of Justice (ECJ) had set hurdles for measures that effectively act as quantitative import restrictions, and the BGH ruling was found to be in compliance with these standards.
The ruling does not address whether the bonuses granted by Tanimis Pharma violate a recently enacted amendment to the Social Security Code. The CEO of DocMorris, Walter Hess, announced that the company would resume offering financial bonuses to its customers due to the ruling. The Federal Association of German Pharmacists' Associations (ABDA) regretted the ruling, but assumes that the social law price binding introduced by the Pharmacy Strengthening Act will remain in place.
The lawsuit was successful in lower courts in Munich, but the Higher Regional Court (OLG) Munich ruled that the price binding is not contrary to EU law. The BGH ruling states that the lawsuit should be dismissed since there is no risk of repetition. If the price binding for prescription drugs is called into question, politics is expected to work with the ABDA to find solutions as quickly as possible.
The question of whether the price binding also applies to mail-order pharmacies in other EU countries or whether it violates the free movement of goods within the EU remains a contentious issue. The BGH referred to the standards of the ECJ in its ruling, stating that the plaintiff did not present sufficient evidence to demonstrate that without the drug price regulation, a comprehensive drug supply could not be maintained. The OLG granted the association's complaint based on the assumption that the regulation is a suitable means of securing drug supply in Germany.
In conclusion, while the specific details of the BGH ruling on drug pricing for mail-order pharmacies from other EU countries compared to German-based ones after the Karlsruhe Federal Court ruling are not available, the ruling does not appear to introduce any new regulations or changes in the Medicines Act. The matter remains subject to national and EU pharmaceutical and trade law frameworks as interpreted by the courts.
- The BGH ruling in January 2025 did not explicitly clarify changes in the economic and social policy regarding mail-order pharmacy drug pricing, leaving the details to be interpreted from the full judgment text or specialized legal commentaries.
- Debates surrounding the BGH ruling have extended to the intersection of science, health-and-wellness, finance, and business, as it questions whether the drug price regulation also applies to mail-order pharmacies in other EU countries, potentially impacting trade and pharmaceutical regulations within the EU.
