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Free samples of medicinal products to pharmacists – Section 7 (1) Health Services and Products Advertising Act (HWG) 

Higher Regional Court, Frankfurt am Main, judgment dated 10 February 2022, Case No. 6 U 161/15

As reported here on 14 April 2021, the plaintiff in the case at issue, based on Section 47 (3) Medicinal Products Act (AMG) and Section 7 (1) HWG, sought an injunction against the distribution of free samples to pharmacies by sales representatives of the defendant of a non-prescription medicinal product (painkiller ointment 100g) in a tube bearing the label “for demonstration purposes”. The Regional Court Frankfurt am Main allowed the action. The appeal against this decision was successful before the Federal Court of Justice (BGH) who referred the case back to for a new hearing and decision.

The OLG Frankfurt am Main thus revises its original position and follows the ratiopharm decision of the ECJ (judgment of 11 June 2020, Case No. C-786/18) and the subsequent BGH decision Apothekenmuster II (judgment of 17 December 2020, Case No. IZR 235/16), according to which an infringement of Section 47 (3) Medicinal Products Act (AMG) can no longer be presumed in the instant case.

A violation of Section 7 (1) sentence 1 HWG is also ruled out in the instant case. It is true that the giving of a free sample of a medicinal product can constitute a benefit in the form of a product. However, in order for it to be impermissible, it must not be a gift of low value within the meaning of Section 7 (1) sentence 1 no. 1 HWG so that improper influence does not appear to be ruled out. For the determination of the value, the consumer or market value of the promotional gift for the average target group (inthe present case, pharmacists) is decisive. If the value of the gift is not insignificant, a prohibition pursuant to Section 7 (1) sentence 1 HWG can only be considered if this practice is likely to create an economic interest in pharmacists in selling this product, which is to be assessed with reference to the above-mentioned decision of the Federal Court of Justice and depending on whether only one or several promotional gifts were given and whether there is a risk that the product will be passed on (unopened) to end consumers.

If, as claimed by the defendant in the present case, the promotional gift in dispute was only supplied for trial by the pharmacist himself and if it is only a single sample, this  in the opinion of the Higher Regional Court of Frankfurt am Main creates the assumption of a gift of low value, but in any case no realistic danger of an improper influence can be assumed. The low value of the promotional gift was also not contradicted by the fact that it contained a 100g of content, which was larger than usual samples. Also, due to the words “for demonstration purposes” printed on the tube, the sales value is substantially lower than the retail price (EUR 5.34). The products, some of which had been given to pharmacists already opened, were considered to be regarded as practically worthless.

The Higher Regional Court of Frankfurt am Main also correctly ruled out a violation of Section 7 (1) sentence 2 HWG. According to this provision, promotional gifts for members of the medical professions are only permissible notwithstanding the provisions of sentence 1 if they are intended for use in medical or pharmaceutical practice. This was affirmed in the present case.

The present decision is consistent and correctly implements the requirements of the ECJ and the BGH. For the sales representatives ofpharmaceutical companies, this results in greater legal certainty with regard to the customary practice of giving to pharmacists, among others, free samples of non-prescription medicinal products for demonstration purposes. It is probably advisable to give out as few samples as possible, or only single samples of a non-prescription product as free samples and, in addition, to label them as such and, if necessary even already opened, in order to ensure that they are not passed on to end consumers.

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