Facts
A. AG is the marketing authorisation holder of the medicine B., authorised by Swissmedic, which is listed on the Specialties List (SL). It contains the active ingredient C. according to the SL, or D. according to the Specialist Information, and is used for the treatment of E.
The Federal Office of Public Health (FOPH) subjected B. to the three-yearly review of the SL listing conditions by circular letter of x and requested, in particular, information on cost-effectiveness, namely on the therapeutic cross-comparison (TQV). A. AG proposed F., G., H., I. and J. as comparator products. The FOPH initially accepted these but then reversed its position and, by analogy with other medicines, separated the galenic forms Oral and OralRetard. The TQV of B. (OralRetard form) was to be carried out only with H. and I. (likewise OralRetard); F., G. and J. (Oral form) were excluded.
As the parties did not reach agreement, the FOPH reduced the ex-factory prices or public prices of B. by decision of x. The Federal Administrative Court dismissed the appeal by judgment of 16 September 2020.
A. AG lodges an appeal under public law and requests that the judgment of the lower court and the FOPH decision be set aside, or alternatively that the matter be remitted for recalculation. The FOPH requests that the appeal be dismissed.
The question at issue is whether the lower court infringed federal law by confirming the price reduction, in particular whether the FOPH exercised its discretion improperly in forming the TQV comparison group (Art. 65d para. 1 HIO in conjunction with Art. 34d and 34f HIBO). The calculation of the foreign price comparison (APV) was undisputed.
Considerations
The term galenic form is defined neither in the HIA, in the ordinances, nor in the SL Handbook. In the pharmaceutical field it denotes the product range of a medicine with different dosage strengths and pharmaceutical forms. According to the SL Handbook, a separate APV and TQV is to be carried out for each galenic form in order to ensure coherence within the pharmaceutical forms, equal treatment of marketing authorisation holders and legal certainty.
According to case law, it is within the FOPH's discretion to determine which and how many medicines are taken as the basis for the TQV. There is no obligation to form the comparison group on the basis of all suitable competing products. Classification by galenic form suggests limiting the TQV to products of the same group, as this compares medicines with the same therapeutic purpose and the same pharmaceutical form. No objective reasons against this approach are apparent.
As a principle, the galenic form or membership of a galenic form is relevant for the selection of comparator medicines: oral with oral, retard with retard forms, and so on. A cross-form comparison is permissible where no comparator medicines exist in the same galenic form. An infringement of Art. 65b para. 4bis HIO and Art. 34f para. 1 HIBO is not apparent. In its circular letters the FOPH further clarified that for Oral and OralRetard products a comparison…