23 gennaio 2022 – In the present decision, the Court had to decide whether the Federal Office of Public Health (FOPH) legally reduced the price and required the appellant to import a smaller package of its medicinal product into Switzerland in the context of the triennial review. The TQV and, in particular, the daily therapy costs of appellant’s medicinal product were disputed. In addition, the parties disagreed whether the criteria of appropriateness of the medicinal product in question could be tied to the condition of introducing a smaller pack. The Federal Administrative Court and FOPH held that the medicinal product was (only) appropriate under the condition that the appellant offers a smaller pack of the product. According to the Court, the FOPH can connect conditions and requirements to the inclusion of a medicinal product on the specialities list (SL) based on art. 65 para. 5 of the Ordinance on contributions in the compulsory Health Insurance (OCHI). Since a medicinal product listed on the SL must fulfil the conditions of inclusion at all times (in accordance with the objective of art. 32 para. 2 of the Federal Health Insurance Act), this must also apply in the context of the triennial review according to the Court. Moreover, the Court held that requirements and conditions did not necessarily require an explicit basis in federal law, but their admissibility could, under certain circumstances, also directly result from the purpose of the law and the related public interest. Accordingly, the Court held that in the case at hand a (sufficient) legal basis for linking the appropriate character of the medicinal product to the condition of introducing a smaller pack existed. Overall, the Court ruled that the condition in question was a proportionate and appropriate measure, which was suitable, necessary and reasonable to reduce the discarding of appellant’s medicinal product and thus the corresponding pharmaceutical waste, thereby relieving the financial burden on the compulsory health insurance.

With regards to the daily therapy costs, the Federal Administrative Court and the FOPH had argued that the costs of one pack were decisive while the appellant argued that the costs of the actually used dose of the medicinal product in question were decisive. According to the Court, both medicinal products – the product in question and the comparable product – had considerable differences in their method of administration and dosage, namely regarding the "waste" problem. Hence, it was justified to treat them differently with regard to the determination of the daily therapy costs. The costs of treatment of the medicinal product under review were therefore to be equated with those of the pack used by the FOPH and the Federal Administrative Court since that pack was eventually charged to the compulsory health insurance, even in cases of lower consumption. Accordingly, the cost comparison conducted by the FOPH and the Federal Administrative Court was made on the basis of the services actually provided by the compulsory health insurance. In addition, the Court disagreed with the appellant, who argued that eventualiter the TQV had to be carried out based on the package that was still to be approved. However, it was not permissible to include future packs or prices according to the Court.

Therefore, the Court dismissed appellant’s appeal.

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