Price review of a medicinal product: Foreign price comparison for pharmaceutically identical products

Facts

Parties and procedural history:

The A. SA (appellant) is the holder of the marketing authorisation for the medicinal product B. registered in Switzerland. Since 15 March 1995, it has been listed in two pack sizes on the List of Specialities (SL) of the Federal Office of Public Health (FOPH) and is used for the prophylaxis and treatment of certain indications. On 13 December 2017, the FOPH informed A. SA that B. would be subject to a triennial review of the conditions for inclusion and requested the submission of relevant data, in particular on the therapeutic cross-comparison (TCC) and the foreign price comparison (FPC).

A. SA argued that B. was not marketed in the reference countries. The FOPH, however, referred to C.B., which is registered in France as a medical device, as a comparator product, since it is pharmaceutically identical (same active ingredient, same dosage form). By decision of 9 April 2019, the FOPH reduced the prices of B. to CHF x (previously CHF x) and CHF x (previously CHF x).

The appeal lodged by A. SA against this decision was dismissed by the Federal Administrative Court in a judgment of 26 May 2021. A. SA then filed an appeal in public law matters with the Federal Supreme Court, seeking the annulment of the contested decision and the maintenance of the previous prices. The FOPH did not submit any observations. By decision of 29 July 2021, the investigating judge ordered a stay of execution. The Federal Supreme Court dismissed the appeal.

Core issue: Whether the lower court violated federal law by confirming the price reduction of B. ordered by the FOPH.

Considerations

Legal basis and purpose of the FPC: The foreign price comparison (FPC) serves to review the economic efficiency of medicinal products as part of the triennial review of the conditions for inclusion in the List of Specialities (Art. 32 para. 1 and 2 HIA, Art. 65b para. 2 lit. a, Art. 65d para. 1 and 2 HIO, Art. 34abis, 34d and 34e HIBO). In the FPC, a Swiss medicinal product is compared with a foreign product of pharmaceutically identical composition, dosage form and use (Art. 34abis para. 2 and 3 HIBO). What is decisive is the substantive identity of the products, not their formal authorisation as medicinal products in the reference country.

Pharmaceutical identity as the central criterion: The Federal Supreme Court emphasises that for the FPC, the active ingredient composition and dosage form are decisive (Art. 34abis para. 2 HIBO). Both products must have the same active ingredient concentration and composition as well as the same dosage form (here: ointment). This applies to B. and the French reference product C.B. The different formal classification as a medicinal product (Switzerland) or medical device (France) is irrelevant for the FPC, since what is decisive is the scientific view and not the authorisation status in the reference country (para. 6.3).

Consideration of different indications: Art. 34abis para. 3 HIBO provides that different indications in Switzerland and the reference countries are not taken into account in the FPC. The main indication (treatment of [...]) is identical in both…