Distribution of free samples of non-prescription drugs to pharmacies
BGH, Judgment dated 17.12.2020 - I Zr 235/16
ECJ decision on free samples C-786/18 of 11.6.2020
The distribution of free samples of non-prescription medicines to pharmacies is generally permissible, according to decision C-786/18 of 11.6.2020.
NEW: Decision of the German BGH
In the German original proceedings of this ECJ decision, the BGH has now taken the second decision and referred the case back to the court of first instance for a new hearing. BGH, Judgment of 17.12.2020 - I Zr 235/16
The legally interesting statement at present is that the distribution of free samples of non-prescription drugs to pharmacists can be regarded as an (impermissible) benefit within the meaning of Section 7 (1) sentences 1 and 2 HWG. The legal situation is not identical with the Austrian one, but comparable. Under Austrian law, the dispensing of physician samples is also explicitly permitted under Section 58 AMG, and therefore there is no violation of Section 55a AMG (granting of advantages to persons authorized to dispense or prescribe). § However, Section 58 AMG, like the corresponding provision in Germany, is specifically directed only at physicians and not at pharmacists, which is why the blocking effect with regard to advantages in connection with sales promotion does not also apply to pharmacists.
Whether or not the prohibition of Section 7 (1d) HWG is fulfilled in the present case, which according to the available information the BGH tends to deny, must now be clarified in the further course of the proceedings.
What does this mean for Austria?
For Austria, this means that in the context of the distribution of free samples of non-prescription drugs to pharmacists, the requirements of Section 55a AMG must nevertheless be met. This means, in particular, that the advantage granted is of low value and is of relevance to pharmaceutical practice. Compared to the dispensing of physician samples, the dispensing of pharmacy samples is thus severely restricted in scope.
You can find the decision here.