13 December 2022
Co-Author: Cao, My Anh
After a pharmaceutical company was prohibited by the Frankfurt am Main Regional Court from distributing free drug samples to pharmacists in 2015, it has now been successful in the appeal proceedings. In its ruling of February 10, 2022 (Ref.: 6 U 161/15), the Higher Regional Court of Frankfurt am Main rejected the plaintiff's request for an injunction and affirmed the permissibility of the further distribution of free drug samples to pharmacists, after the appeal was initially unsuccessful. On appeal by the defendant company, the BGH suspended the proceedings and referred questions to the ECJ on compatibility with European Union law. The ECJ then ruled on June 11, 2020, that Article 96 (1) of Directive 2001/83/EC must be interpreted as meaning that this provision does not preclude the distribution of free samples of non-prescription medicines to pharmacists (see ECJ, GRUR 2020, 764 - Ratiopharm).
The Higher Regional Court of Frankfurt am Main now ruled that there was no risk of the packages being passed on to the end consumer unopened and of the pharmacist being improperly influenced and that a violation of Section 7 (1) sentence 1 no. 1 HWG could not be assumed either, since the drug samples were a marginal donation. A product labeled "For demonstration purposes" was not intended for sale and could not be equated with a commercially available original. Rather, the value of the product is reduced. In the absence of a relevant danger, a violation of Section 47 (3) AMG was also not apparent. Rather, it is in the interest of a pharmacist to familiarize himself with new drugs and gain experience in their use. It is evident that the provision of a single copy is intended primarily for the pharmacist's own testing and that of his staff. It is important to note, however, that this liberal case law only applies to non-prescription drugs.