New ruling regarding liability for unlawful behavior in relation to sale of medicinal products

On 9 March 2018, the Danish Maritime and Commercial High Court found that KRKA Sverige AB's unlawful notification of smaller packages of medicinal products violated the Marketing Practices Act.

Under the Danish rules on substitution, synonymous medicinal products are placed in the same substitution group and the pharmacies are obliged to dispense the cheapest product unless the doctor or the patient declines this.

In this case, KKRA and Sandoz had medicinal products in the same substitution group. KRKA notified the Danish Medicine Agency (DMA) of a new package size, which meant that Sandoz' products were ousted from the substitution groups, due to specific package size requirements. KRKA were not able to deliver the packages in question and the notifications therefore violated the delivery requirement in the Medicines Act.

The court stated that the KRKA should have realised this and KRKA had therefore acted contrary to good marketing practices and were liable for Sandoz' consequential loss.

With the ruling, it is established that actions in violation of specific rules in the Medicines Act might also constitute a violation of the general rules in the Marketing Practices Act.

A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, March 2017 Issue (Thomson Reuters).

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