Federal Administrative Court, Decision C-1205/2018 from 8 November 2021

3 December 2021 – Presently, the Court had to examine whether the price reduction of around -50% ordered by the Federal Office of Public Health (FOPH) in the context of the triennial review was lawful. Both the APV and TQV were disputed. With regards to the APV, the court stated that contrary to appellant’s argumentation, the APV – unlike the TQV – does not focus on a cost-benefit analysis, but on a pure price comparison of the same medicinal product in Switzerland and abroad. Accordingly, the Court held that the FOPH rightfully used the disputed products and reference countries for the APV and thus the APV was carried out legally. However, the TQV proved to be unlawful, since a single TQV should have been carried out instead of several TQVs for the same medicinal product. Due to the fact that the medicinal product under review existed with two different dose strengths, the FOPH had argued that two TQVs had to be carried out: one comparison group for systemic therapy and a second comparison group for local therapy. The Court established that both products contained the same active ingredient, the same excipient and were offered in the same form of suspension for injection and that they were thus undoubtedly the same medicinal product. Moreover, they had the same pack size. However, one of the products featured the smallest dosage. The Court repeated the principle that a TQV should be based on the smallest package and dosage. Exceptionally, the FOPH may deviate from this principle in certain cases. However, the Court held that it was not possible to deviate from the principle in the case at hand and thus the approach taken by the FOPH was inadmissible. Furthermore, only comparative products should have been included in the TQV that covered the broad scope of application of the medicinal product at hand.

Therefore, the Court upheld the appeal and referred the case back to the FOPH.

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