Federal Administrative Court, Decision C-5955_2019 from 28 January 2022

18 February 2022 – In this case, the Federal Administrative Court had to examine whether the price reduction ordered by the Federal Office of Public Health (FOPH) as part of the triennial review of admission conditions was lawful. The appellant argued that the FOPH wrongfully determined the main indication of the medicinal product in question by solely relying on prevalence figures of the medicinal product. Furthermore, contrary to the FOPH’s view, the appellant argued that the therapeutic cross comparison (TQV) should be based on the average price of both and not only one galenic dosage form of the medicinal product.

After careful examination, the Court decided that there were sufficient medical reasons that supported the claim of the appellant in the medical practice of long-term therapy. Additionally, the guideline of the list of specialties offered sufficient scope to take into account other criteria than prevalence figures for determining the main indication of a medicinal product. Hence, the Court held that the FOPH had violated federal law by basing its decision regarding the main indication solely on prevalence figures. In addition, both galenic dosage forms were to be included in the TQV calculation, according to the Court.

The appeal was upheld to the extent that the case was referred back to the FOPH for a new decision in accordance with the recitals.

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