Federal Administrative Court, Decision C-573/2018 of 13 March 2021

7 mai 2021 – In this decision, the Federal Administrative Court had to examine whether the economic efficiency test in the two procedures - foreign price comparison (APV) and therapeutic cross-comparison (TQV) - was carried out lawfully. The appellant contested the admissibility of the deduction of minimum margins according to the SL Manual. It claimed that it had entered a wholesale margin of 0 % in the APV for the Netherlands, Sweden and the United Kingdom and could prove this, but that the Federal Office of Public Health (FOPH) always (wrongly) took into account the minimum margin in accordance with point C.3.2 of the SL Manual. Furthermore, the appellant complained that the FOPH had carried out the TQV incorrectly by reducing or deleting the innovation surcharge on the occasion of the triennial review.

After careful examination, the Federal Administrative Court came to the conclusion that the required proof for determining the amount of the innovation surcharge had not been provided in a comprehensible and appropriate manner on the basis of the files available. Consequently, the appeal was partially upheld and the case was referred back to the FOPH so that the FOPH, after carrying out the additional clarifications and completing the justification in accordance with the recitals, could make a new decision on the prices.

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