Three-yearly review of a medicine on the List of Specialties: therapeutic cross-comparison with an off-patent reference preparation permissible as long as the indication extension procedure has not been concluded

Facts

The appellant, [A. AG] , is the marketing authorisation holder of the oncology medicine [X.] ® (active substance [B.] ), which has been listed on the List of Specialties (SL) without restriction since 1 August 2005.

The Federal Office of Public Health (FOPH) subjected [X.] ® to the three-yearly review of the SL listing conditions pursuant to Art. 65d HIO by circular dated 10 February 2017. The appellant argued that the preparation enjoyed first-applicant protection until 2020 on the basis of an indication extension (advanced or metastatic breast cancer). It wished to submit notification of this new indication as of 26 June 2017. It requested that the therapeutic cross-comparison (TQV) be carried out with patent-protected preparations such as [Y.] ®.

After unsuccessful attempts at agreement, the FOPH issued a decision on 14 December 2017 carrying out a TQV with the off-patent preparation [Z.] ®, found [X.] ® to be uneconomical, and reduced the public price as of 1 February 2018 (capsules 20 mg: CHF 63.35; 30 mg: CHF 86.85). The reference date for the TQV was 1 July 2017.

In its preliminary decision of 30 March 2017, Swissmedic had envisaged partial approval of the indication extension and issued this decision on 7 July 2017 with three-year first-applicant protection. The EAK assessment and the FOPH decision on the indication extension were still outstanding on the reference date. The FOPH maintained the TQV within the framework of the three-yearly review.

The Federal Administrative Court dismissed the appeal by decision of 12 March 2020 (C-612/2018). [A. AG] lodges a public law appeal and requests that the decision be set aside, or alternatively that the matter be remitted with the instruction to carry out a TQV with preparations protected by intellectual property rights. The FOPH requests dismissal.

The subject matter of the dispute is whether the lower court violated federal law by upholding the price fixed by the FOPH for [X.] ®.

Considerations

The Federal Supreme Court examines the application of law ex officio (Art. 106 para. 1 FSCA) and is bound by the lower court's findings of fact unless they are manifestly incorrect (Art. 105 FSCA). A manifest incorrectness exists only where the findings are clearly and obviously incorrect. The lower court correctly set out the principles on efficacy, appropriateness and economic efficiency (Art. 32 HIA, Art. 65b, 65d, 65f HIO, Art. 34f HIBO).

There are two independent review procedures: the three-yearly review pursuant to Art. 65d HIO applies to all SL medicines with 1 July of the review year as the reference date, whereby changes to comparator preparations are only taken into account up to that date (Art. 34f para. 3 HIBO). The procedure under Art. 65f HIO concerns the indication extension; there, the time of the decision is decisive for the TQV and the EAK must be consulted. For patent-protected original preparations, the TQV is regularly carried out with likewise patent-protected preparations in order to take account of research and development costs (Art. 65b paras. 6 and 7 HIO).

On the reference date of 1 July 2017, only a preliminary decision by Swissmedic with announced first-applicant protection existed for the main indication. The indication extension procedure under Art. 65f HIO had not been concluded, as neither an EAK recommendation nor a FOPH decision existed. Without a formally approved indication extension on the reference date, the FOPH was entitled, in the procedure under Art. 65d HIO, to draw on an off-patent reference preparation. There is therefore no violation of federal law by the lower court.

The appellant cannot derive anything to the contrary from first-applicant protection. According to the Message on the Therapeutic Products Act, first-applicant protection…