Federal Administrative Court, Decision C-613/2018 of 7 September 2021

14 October 2021 – In this decision, the court assessed firstly, whether the Federal Office of Public Health (FOPH) violated federal law when conducting the TQV by basing it on a selection of medicinal products of only one class of active substances and secondly, whether the average dosage was calculated correctly. The court held that the FOPH possesses a wide discretion as to the selection of medicinal products and that, contrary to the appellant’s argumentation, it is not obliged to include all obtainable medicinal products with the same indication. The used products, having all the same active substance and a similar indication, were suited for the comparison. With regards to the dosage, the court outlined that pursuant to the Ordinance on Health Insurance, the SL-manual as well as the FOPH commentary a TQV should be carried out with the smallest package and lowest dosage. The fact that the FOPH primarily focused on the dosage is in line with the legal basis and jurisprudence. However, the court declared that by using a medicinal product that was not on the list of pharmaceutical specialities at the time of the ruling and by deviating in one instance from the procedure of using the pack with the lowest dosage, the lower instance had not executed a lawful TQV and not based its ruling on a legally acceptable factual situation. Consequently, the court annulled the ruling and referred the case back to the lower instance.

For more information, see here.