Decision C-5986/2019

2 novembre 2023 – A. SA is the marketing authorization holder for the drug B., which can be found on the list of pharmaceutical specialities (LS). The Federal Office of Public Health (FOPH) carried out a review of the admission requirements for the LS and asked A. SA to submit the relevant data. As part of the review, the FOPH conducted a foreign price comparison (FPC). Since it noticed that drug B. was sold in Germany and the Netherlands under the name N., the FOPH included N. in the FPC. The FOPH stated that an FPC is carried out irrespective of the designation in the reference country, the marketing authorization holder in the reference country, the remuneration in the reference country and irrespective of whether the Swiss marketing authorization holder can influence the ex-factory price. Ultimately, the FOPH included N. (in Germany; not in the Netherlands as N. in the Netherlands contains monodoses and not daily doses). In the FPC and lowered the price of B. based on the FPC by order dated 10 October 2019.

A. SA challenged this order by filing a complaint with the Federal Administrative Court and requested that the order be revoked and the price not be reduced, justifying this with a violation of its right to be heard and an unlawful FPC. The court found no violation of the right to be heard.

The court further examined whether the lower instance duly exercised its discretion in selecting the reference countries and the reference drugs used for the FPC. The complainant’s primary objection was that B. and N. were not identical medications, as they are sold and manufactured by different and independent companies. Regarding the implementation of the FPC, art. 34abis para. 2 HIBO stipulates that comparisons must be made with the same medicinal product in the reference countries, regardless of the name of the product or the authorization holder. Original preparations with the same active ingredient composition and the same dosage form are considered the same medicines. The court stated that the FOPH was right to consider B. and N. identical. Therefore, the court held that N. (Germany) was rightly included in the FPC. 

Next, the court investigated whether the lower instance had rightly decided not to take the reference country of the Netherlands into account. The German and Dutch N. are identical medicinal products within the meaning of art. 34abis para. 2 HIBO. Therefore, N. (Netherlands) must generally be included in the FPC. There is, however, a difference in the primary packaging of the drugs. B. is available as a resealable daily dose container, N (Germany) as a resealable one-dose container. N. (Netherlands), on the other hand, is available in ampoules, which must be destroyed immediately after use (monodoses). According to the case law of the Federal Administrative Court, it is appropriate to generally compare drugs with the same dosage strength or with the same package size, provided such a comparison is at all possible. It can therefore be assumed that an FPC with preparations of a different dosage strength or package size is only permitted in exceptional cases. Therefore, the lower instance had the right to exclude N. (Netherlands) from the FPC.

The Federal Administrative Court confirmed the contested order and dismissed the complaint.

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