Federal Administrative Court, Decision C-6601/2018 from 17 November 2021

31. December 2021 – In the present case, the court had to examine whether the reclassification of appellant’s medicinal product to IT group 10.10 and the point limitation introduced for the small pack ordered by the Federal Office of Public Health (FOPH) were legal, especially with regards to their appropriateness. The Court held that the decision to reclassify could be appealed in the case at hand as it had direct economic consequences for and constitutes a (direct) encroachment on the legal position of the appellant. Contrary to the argumentation of the FOPH, the allocation of a medicinal product by Swissmedic to a specific IT group does not prejudice the allocation in the specialities list. The Court further pointed out that a medicinal product is only classified in one IT group, even if it has several indications for which a medicinal product authorisation has been granted. By basing the reclassification solely on the alleged practice, the FOPH did not carry out an examination of the criteria of efficacy, appropriateness and cost-effectiveness and thus the reclassification was illegal. In addition, the court agreed with the appellant, who claimed unequal treatment related to other comparable medicinal products.

As a consequence, the Court upheld the appeal and referred the case back to the FOPH.

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