Federal Administrative Court, Decision C-640/2018 of 6 January 2021

22 gennaio 2021 – In this decision the Federal Administrative Court assessed whether the Federal Office of Public Health (FOPH) was entitled to omit the therapeutic cross comparison (TQV) within the context of the three-yearly price review. The court held that the FOPH must always conduct a TQV whenever possible and that it has no discretionary power in this regard. It stated that in this case, there were numerous therapeutic alternatives for the treatment of the same disease within the meaning of Art. 65b Para. 4bis lit. a KVV and that a comparison was therefore possible. It held that a comparison grouping within the framework of the TQV may also be determined exclusively on the basis of the criteria of the widely "identical indication" and that, in the present case, medicinal products were on the market which would serve to treat the same diseases and were also sufficiently similar with regard to the warnings and precautionary measures in the medicinal product information.

For the full decision see here.