Facts
A. SA, as the marketing authorization holder of the medicinal product B., submitted documents to the Federal Office of Public Health (FOPH) on December 20, 2011, for the purpose of reviewing the reimbursement conditions of B. after patent expiry. The FOPH intended to reduce the prices across all packages of B. by 21.24%, based solely on an international price comparison (IPC) and without considering a tolerance margin.
A. SA filed an appeal against the FOPH's decision of June 21, 2012. The Federal Administrative Court annulled the decision and remanded the case to the FOPH, so that it could make a new decision on the price reduction after conducting a comprehensive economic evaluation based on an IPC and a therapeutic cross-comparison (TCC).
The FOPH filed an appeal in public law matters, requesting the Federal Supreme Court to annul the decision of the Federal Administrative Court and confirm the FOPH's decision of June 21, 2012.
Considerations
The Federal Supreme Court dismissed the appeal. It concluded that, in principle, a comprehensive economic evaluation - based on an IPC and a TCC - must be carried out after the expiry of the patent protection. To the extent that the FOPH's manual on the Specialty List (SL) in Section F.1.3 provides for an economic evaluation primarily based on an IPC, it is unlawful.
The Federal Supreme Court stated that the wording of Art. 65e of the Health Insurance Ordinance (KVV) (in conjunction with Art. 65 para. 3 and Art. 65b KVV) speaks in…