Federal Supreme Court, Decision 9C_537/2020 of 13 April 2021

14. Mai 2021 – In this decision, the Federal Supreme Court had to assess whether the lower court violated federal law by confirming the reduction in the price of the appellant's medicine ordered by the Federal Office of Public Health (FOPH). The FOPH had ordered a reduction in the public prices of the appellant's preparations listed in the list of specialties as part of the triennial review of the conditions for inclusion. The appellant appealed against this first unsuccessfully before the Federal Administrative Court and finally before the Federal Supreme Court. The appellant primarily objected to the FOPH's formation of TQV comparison groups. The appellant claimed that the FOPH had improperly exercised its discretion in this area by approving only one medicinal preparation as a comparative medicine and not also the preparations proposed by the appellant. The appellant also argued that the TQV had not been carried out on the basis of the smallest packaging, contrary to what was required by the regulations.

The Federal Supreme Court considered that the FOPH has a wide margin of discretion in the selection of the comparative medicinal preparations. In particular, it is at the discretion of the FOPH to decide in each individual case which, and thus also how many, of the medicines in question (i.e. comparable medicines) the TQV should effectively be based on in order to achieve healthcare of impeccable quality at affordable costs. In each individual case, the Federal Supreme Court only has to evaluate whether the Federal Office has exercised its broad discretion appropriately or whether the lower court has exercised its discretion erroneously in law. In particular, the court does not see any abuse of discretion in the FOPH's procedure of including only one medicine with an identical indication and mode of action - and therefore serving the treatment of the same disease - in the TQV. Furthermore, it does not accept the accusation of arbitrariness. It is irrelevant whether the additionally required preparations are actually more practicable in handling. This is because the FOPH chose a suitable comparative preparation with a comparable cost-benefit ratio for the TQV according to the legal requirements. The formation of the comparison group was therefore in conformity with federal law. The other objections raised in the appeal could not change this result.

The appeal was dismissed by the Federal Supreme Court.

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