The judgement of the Higher Administrative Court of Mannheim: Dispensing of medicinal products by means of dispensing machines

In 2017, a Dutch mail-order pharmacy was prohibited from dispensing pharmacy and prescription drugs to its customers by means of a remote-controlled dispensing machine without a pharmacy license by an order of the local authority of Karlsruhe.

In its judgement of 21 October 2021 (ref. 9 S 527/20), the Higher Administrative Court of Mannheim confirmed this official prohibition. In the opinion of the Court, the distribution channel practiced by the plaintiff cannot be subsumed under the numerus clausus of permissible forms of marketing pharmacy and prescription drugs to end consumers. The dispensing of pharmaceuticals by means of dispensing machines with the involvement of a video advisor does not represent a new form of marketing pharmacy or prescription pharmaceuticals but it is merely a technically modified form of dispensing pharmaceuticals in a de facto retail pharmacy.

The dispensing of medicinal products from pharmacy premises by pharmaceutical staff was already inadmissible due to the lack of a pharmacy license pursuant to Section 1 (2) ApoG. In addition, it is also not a permissible mail order business from a Member State of the European Union pursuant to Section 73 (1) No. 1a AMG. For this, the direct dispatch of the medicinal products from the pharmacy to the final consumer is missing.

The decisive criterion for distinguishing between the mail order business and the dispensing of medicinal products from a retail pharmacy is precisely the transport and delivery of the medicinal products to the customer. According to the Higher Administrative Court, this criterion is not fulfilled by the distribution method practiced by the plaintiff.

The dispatch of the medicines from the business premises in the Netherlands to Germany was carried out in order to stock the medicines warehouse prior to the initiation of the contract with the end consumer. According to the Court, this mere stockpiling is not covered by the concept of placing it on the market. This is not changed by the transport "on the last mile" between the drug warehouse and the end user via a conveyor belt, as the plaintiff had argued.

In particular, the dispensing of pharmacy and prescription drugs through automated dispensing stations regulated in Section 17 (1) b sentences 1 and 3 ApoBetrO does not constitute an independent form of distribution. This is mere to be seen as a special distribution modality, which is assigned to the distribution forms of dispensing in pharmacy premises or by way of authorized mail order. The requirement either to have a pharmacy license pursuant to Section 1 (2) of the German Pharmacy Act (ApoG) or to participate in a permissible manner in the mail-order trade of medicinal products pursuant to Section 11a of the German Pharmacy Act (ApoG) or Section 17 (1) sentence 1 no. 1a of the German Medicines Act (AMG) was not obsolete according to the legislative intent.

Finally, the Higher Administrative Court, referring to the case law of the Court of Justice of the European Union, emphasizes the compatibility of the restrictions on the marketing of pharmacy and prescription drugs to end consumers with Union law. Even if this were an interference with the free movement of goods under Article 34 TFEU, it was justified under Article 36 TFEU. In view of the high priority of the affected legal interests of human life and health, the Member States are entitled to a discretionary scope with regard to the question at which level the protection of public health is to be ensured and how this level of protection is to be achieved. The numerus clausus of permissible forms of marketing of pharmacy and prescription medicinal products to end consumers corresponds to this discretionary scope.

Authors: Dr. Daniel Tietjen, Farina Simon