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German court rules against automated dispensing of medicinal products

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Christian Meyer of Maiwald explores a recent decision which prevents the distribution of medicinal products by means of an automatic dispenser from a foreign mail-order pharmacy

The Federal Court of Justice (FCJ) recently ruled that a Dutch mail-order pharmacy is not allowed to dispense medicines via automatic dispensing machines in Germany because this would not guarantee the safety of medicines (decision of April 30 2020, docket no. I ZR 123/19).

In the opinion of the FCJ, the sale of medicinal products from abroad by means of an automatic dispenser operated in Germany does not constitute "shipment to the end consumer from a pharmacy" within the meaning of Section 73(1) no. 1 lit. a) of the Pharmaceutical Products Act.

The FCJ states that the Court of Appeal was right to hold that the restrictions on the supply of medicinal products which were not observed by the defendant, in particular the national pharmacy obligation (first sentence of Section 43(1) of the Pharmaceutical Products Act) and the modalities of a permissible shipment under Section 73(1) no. 1 lit. a) of the Pharmaceutical Products Act, which require shipment directly from the pharmacy to the customer, serve to ensure the safety of medicinal products and are justified in the interest of a high level of protection for the final consumer pursuant to Article 36 TFEU.

The Court of Appeal did not err in law by finding that the distribution model of the defendant, domiciled in the Netherlands, does not satisfy the requirements of pharmaceutical safety as stipulated in the national provisions directly aimed at protecting public health.

The non-admission complaint against the Court of Appeal’s ruling was rejected by the FCJ owing to a lack of fundamental significance, as was a referral to the Court of Justice of the European Union. In the opinion of the Federal Court of Justice, this is not a case of unlawful interference with the free movement of goods (Article 34 TFEU) and, in any case, such interference would be justified in order to protect the health and life of humans.

Christian Meyer

Principal, Maiwald


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