In the underlying case, the plaintiff, making refence to Section 47 (3) AMG (Medicinal Products Act) and Section 7 (1) HWG (Law on Advertising in the Health Care System), requested an injunction against the distribution of free samples of non-prescription medicinal products, labelled "for demonstration purposes", to pharmacies by the defendant’s sales representatives. Both the Regional and Higher Regional Courts granted the injunction claim.
In the context of a reference for a preliminary ruling by the FCJ as appellate court, the ECJ concluded that Article 96(1) of Directive 2001/83/EC (as amended by Directive 2004/27/EC) should be interpreted as (only) forbidding pharmaceutical companies from providing free samples of prescription drugs to pharmacists (judgment of 11 June 2020, Case C-786/18 - ratiopharm).
Against this background, the FCJ allowed the defendant's appeal (judgment of 17 December 2020, Case No. I ZR 235/16 - Apothekenmuster II).
In the FCJ’s opinion, there was no infringement of Section 47 (3) AMG. This was an implementation of Art. 96 (1) and therefore had to be interpreted in conformity with the Directive. In this respect, it must also be considered that the Directive distinguishes between prescription and over-the-counter medicinal products. According to the meaning and purpose of Article 96(1), only free samples of prescription drugs are covered by this provision. Therefore, Article 96(1) does not preclude the supply of free samples of over-the counter medicinal products, and the same applies to Section 47(3) of the AMG.
However, according to the FCJ, this could constitute a violation of the prohibition of advertising gifts pursuant to Section 7 (1) sentence 1 HWG ("gift in the form of a product"). In the absence of findings by the lower courts, the BGH was not able to examine this. However, the FCJ advises the court of appeal, for the renewed examination, to determine whether the medicinal products that were given away were of low value and, if not, whether this was suitable to inadmissibly influence the pharmacists’ dispensing practice. This could depend, inter alia, on whether only one free sample or several had been supplied to each pharmacist and, from this amount, could have been passed on by them to their customers for the purpose of increasing customer loyalty (FCJ, loc. cit., para. 33). If this is not the case and the defendant had supplied the free samples only for testing by the pharmacist themselves, this could justify an objective interest of pharmacists in familiarising themselves with new medicinal products and being able to gain experience in their use (see ECJ, loc. cit., para. 49 with reference to the 51st recital of the Directive).
For the sales force of pharmaceutical companies, this is thus a further ruling on the subject of promotional products, which must be adhered to. In practice, it is advisable to hand out as few samples as possible of an over-the-counter product as free samples to pharmacies and to label them accordingly so that they are not passed on to consumers.
Our blog contributions shall provide an overview with regard to legal topics, legislation and case law and are supposed to provide some general information rather than constituting any specific advice. Please do not hesitate to contact Maiwald and in particular the authors of the particular contributions if have any questions on the addressed topics or on other legal issues.