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Federal Administrative Court, Decision C-1197/2018 from 12 October 2021

5. November 2021 – It was disputed among the parties which medicinal products were to be included in the TQV. The court had in particular to examine whether the lower instance had improperly exercised its wide discretion when selecting the comparative medicinal products for the TQV. According to the court, a TQV can be performed based on only one comparative product. It held that the comparability of possible comparative products should be assessed based on the wording of the marketing authorisation under the therapeutic products legislation respectively the corresponding SmPC. The appellant had requested that various additional comparative products be included in the TQV. As these additional comparators, unlike the medicinal product in question, could also be used for long-term treatment based on their respective SmPC, the court – in line with the lower instance – held that this difference was enough to exclude these comparators from the TQV. In other words, by basing the exclusion of these medicinal products on the SmPC the lower instance had based its decision on a factual and comprehensible reason. Accordingly, the lower court could not be accused of improper exercise of its wide discretion in the selection of the comparative products and therefore the TQV had been carried out in legal manner.

The court further held that the appellant could not invoke economic freedom or art. 118a of the Constitution. Consequently, the court dismissed the appeal.

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