Federal Administrative Court, Decision C-5962/2019 from 25 October 2021

11 novembre 2021 – In the present decision, the Federal Administrative Court had to examine whether the Federal Office of Public Health (FOPH) correctly carried out a TQV in the context of the triennial review of the admission conditions. To substantiate that two comparative medicinal products have other main indications, the appellant argued that they both only had a minor market share in the same field as the medicinal product in question. Hence, these products have other main indications. The lower instance responded that it was irrelevant whether the comparative medicinal products were sold frequently or not. The only relevant factor in determining the comparator products was whether they were medicinal products for the treatment of the same disease. The Court supported the view that market shares were not a determining factor; however, it did not find matching indications of the compared medicinal products. Therefore, the Court concluded that the case had to be referred back to the lower instance for further clarification regarding the main indication of the medicinal product in question and for a related review of the appropriate comparator medicine(s). While the court did not comment on the different dosage forms, it did note that the appellant rightly claimed that its medicinal product was a mono preparation, whereas one of the comparative products was a combination preparation. Hence, if the lower court concludes that this product is a comparable medicinal product, this discrepancy will need to be addressed and justified.

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