Federal Supreme Court, Decision 9C_400/2021 of 20 April 2022
13 maggio 2022 – In the present case, the question at issue was whether the Federal Administrative Court violated federal law by upholding the Federal Office of Public Health (FOPH)'s order to reduce the price of a drug. The Federal Supreme Court (hereinafter the Court) had to assess whether the lower court (Federal Administrative Court) violated Art. 34abis para. 2 KLV by comparing the medicinal product under the foreign price comparison (APV) with a preparation marketed in France as a medical device but not as a medicinal product. The Court confirmed the decision of the Federal Administrative Court, in which the lower court found that the foreign price comparison (APV) carried out by the Federal Office of Public Health (FOPH) was based on valid grounds. The corresponding explanations of the FOPH that the term "same medicinal product" used in Art. 34abis para. 2 of the Ordinance on the Indemnification by Compulsory Healthcare Insurance (KLV) is to be interpreted in the sense of a material understanding were convincing.
Materially, the Court ruled that the comparison of the Swiss medicinal product with a foreign product of pharmaceutically identical (active ingredient) composition, dosage form and application was at the centre of the APV according to Art. 34abis para. 2 and 3 KLV. In particular, it was of secondary importance, and thus not decisive for the question of inclusion within the scope of application of the APV, whether a preparation bore the designation "medicinal product" in the reference country, i.e. whether it was formally labelled as such by the competent foreign licensing authority in accordance with the legal definition there. The "same medicinal product" within the meaning of Art. 34abis para. 2 and 3 KLV was rather to be determined on the basis of a material understanding. In summary, the scientific point of view was to be weighted more heavily than any divergent approval status of the reference product in the comparator country.
Therefore, the Court dismissed the appeal.
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