Pharmacy Granted Authorization for Elevated Pricing Locks
In a recent ruling, the Federal Court of Justice (BGH) in Karlsruhe reaffirmed a decision made more than a decade ago, allowing a mail-order pharmacy based in an EU country to offer customers in Germany bonuses on prescription drugs. However, the court's decision comes amidst a tightening of regulations in the German pharmaceutical sector, particularly in relation to medical cannabis and pharmacy advertising.
The ruling, which does not specifically mention a case involving "Tanimis Pharma," has sparked controversy among some industry stakeholders. The Bavarian Pharmacists' Association, for instance, argued that the practice contravened competition law and drug price binding, leading to a lawsuit. However, the BGH, in adherence to guidelines from the European Court of Justice (ECJ), dismissed the complaint due to a lack of sufficient data proving a comprehensive medicine supply risk without price-fixing.
Meanwhile, Germany is implementing stricter regulations for medical cannabis. Prescriptions will now require in-person doctor visits, and medical cannabis will no longer be available by mail order. Instead, it must be dispensed in pharmacies, ensuring comprehensive information and consultation obligations are met. This shift towards stricter regulations suggests a more stringent approach to ensuring compliance with German healthcare laws, including eliminating models that rely on online questionnaires for medical prescriptions and enforcing strict due diligence for pharmacies dispensing prescription drugs.
A recent judgment by the Higher Regional Court (OLG) Frankfurt am Main reinforces these strict restrictions on financial incentives in connection with prescription-only medicines. Offering vouchers for redeeming electronic prescriptions or first-time orders via an app was deemed to contravene the prohibition on benefits under Section 7(1) of the German Act on Advertising in the Healthcare Sector (Heilmittelwerbegesetz – HWG).
The ABDA, the Federal Association of German Pharmacists' Associations, regretted the BGH's ruling on mail-order pharmacy bonuses but acknowledged that the price binding introduced by the Pharmacy Strengthening Act remains in place, subject to the review of the written reasons for the decision. If the price binding for prescription drugs is called into question, politics would need to work with the ABDA to find solutions as soon as possible, according to ABDA President Thomas Preis.
It is essential to note that the tightening of regulations around medical cannabis and pharmacy advertising is part of a broader effort to ensure compliance with German healthcare laws. While the BGH's ruling on mail-order pharmacy bonuses may have been upheld, the landscape of the German pharmaceutical sector is evolving, with stricter regulations and a renewed focus on patient safety and compliance.
The BGH's decision on mail-order pharmacy bonuses, while upheld, doesn't apply to the regulation of financial incentives in connection with prescription-only medicines, such as medical cannabis, as the Higher Regional Court Frankfurt am Main recently reinforced strict restrictions on such practices. Consequently, policy makers and the ABDA may need to collaborate in addressing potential challenges to price binding for prescription drugs, thus emphasizing the importance of science and health-and-wellness compliance within the evolving German pharmaceutical sector.
