Facts
In the context of the triennial review of the admission conditions for medicinal products in the Specialty List, the Federal Office of Public Health (FOPH) informed [A. AG] that the prices for the generic products B.® Nasal Spray and B.® Tablets must be reduced in order to maintain the 20% differential to the average foreign price of the original products C.® Nasal Spray and C.® Tablets as required by Art. 35b para. 10 KLV. [A. AG] filed a complaint against this price reduction and requested that the prices be reduced according to the FOPH's calculation method, but with a reduction rate of 10%.
Considerations
The Federal Supreme Court concluded that Art. 35b para. 10 lit. a KLV also applies to those generics that were included in the Specialty List before January 1, 2012. The contrary conclusion of the lower instance, the Federal Administrative Court, was found to be in violation of federal law.
The wording of Art. 35b para. 10 lit. a KLV allows for a retrospective examination of whether the ex-factory prices of the generic at the time of inclusion in the Specialty List met the requirements of Art. 65c para. 2 lit. a KVV. The wording does not support a limitation to generics that were included in the Specialty List…