3. März 2022 – Presently, the appellant argued that it was unlawful to carry out the TQV in the context of the triennial review under different circumstances than the first TQV – based on which the medicinal product was included in the list of specialties – as neither the facts nor the legal situation had changed since then. However, the Federal Supreme Court held that both the relevant legal basis as well as the initial situation had changed. The Federal Office of Public Health (FOPH) was thus allowed to carry out the TQV differently. The Federal Supreme Court further rejected the argument of the appellant that the selection of comparative products made by the FOPH was unlawful. It established that within the framework of the TQV, not only medicinal products that are identical with regards to their indication are to be authorised, but also those that are comparable at least with regards to their main indication. The comparative products used in the case at hand were undisputedly preparations belonging to the same gamma and were as such to be regarded as suitable comparative products for the TQV. Consequently, as previously recognised by the Federal Administrative Court, the FOPH could not be accused of improperly exercising its discretionary powers.

Therefore, the Federal Supreme Court rejected the appeal.

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