Federal Administrative Court, Decision C-6596/2018 from 15 March 2022

31 marzo 2022 – In the present case, it was disputed whether the Federal Office of Public Health (FOPH) had correctly carried out the TQV. In particular, it was disputed which comparative products were to be included as well as the exact dosage of appellant’s medicinal product on the basis of which the daily therapy costs were determined. All medicinal products used for the TQV were so-called herbal medicinal products (Phytoarzneimittel). These are medicinal products with a stated indication that contains exclusively one or more herbal substances or herbal preparations as active ingredients, and which do not belong to the complementary medicinal products. The Court held that when assessing the comparability of the preparations, the wording of the marketing authorisation under medicinal product law or the corresponding expert information (or corresponding patient information) are to be taken into account. The Court proceeded by examining the comparability of all involved products and concluded that the FOPH's broad discretion in selecting the comparative preparations was not violated in the present case.

With regards to the determination of the dosages for the TQV, the Court stated that if a SmPC contains a clear statement on the recommended or usual dosage with regard to the average maintenance dose, this was to be used as the basis for the TQV. If there was a lack of such precise information, the entire dosage range listed in the SmPC is in principle to be taken into account and based on its mean value. Based on the SmPC of appellant’s medicinal product, the FOPH should have considered a dosage of 2 film-coated tablets according to the Court. Moreover, the TQV carried out by the Court showed that the (list of specialities) prices for the medicinal product in question should not be reduced.

Therefore, the Court upheld the appeal and annulled the order of the FOPH.

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