Federal Administrative Court, Decision C-2728/2019 of 13 September 2019
26. September 2019 – In its decision of 13 September 2019, the Federal Administrative Court did not approve the appeal of a licence holder for a certain medicine that is registered for the treatment of certain diseases by Swissmedic. In their decision, they found that there was no object of appeal and therefore the procedure prerequisites were not given.
The appellant argued that the HTA (Health Technology Assessment) Scoping Report that was published on the website of the Federal Office of Public Health (FOPH) bears the characteristics of a decree in the sense of Article 5 of the Administrative Procedure Act (APA; Verwaltungsverfahrensgesetz; SR 172.021). However, the Federal Administrative Court considered that the HTA would be an instrument for the evaluation of medical technologies. The principal goal would be to compare the effectiveness and safety of a certain drug with a placebo and with other drugs, while it could be the basis of a subsequent decision regarding a listing on the Specialities List (SL). The Scoping, however, would be conducted prior the HTA as it has the purpose to evaluate the feasibility of the HTA and define the object and methods of investigation for the HTA.
In an earlier decision, the Federal Administrative Court held that a HTA does not affect the rights or duties of the appellant (C-2161/2017, C-1747/2019 from 6 June 2019; see also here for the news report). Only in a procedure following the HTA that regards the deletion or limitation from the Specialities-List, the appellant will be granted her rights as a party. As a consequence, taking into account this case law, the Federal Administrative Court argued in this decision that since the introduction and conduct of a HTA do not constitute decrees, a Scoping Report, which is only a staging post to a HTA, cannot qualify as a decree, either. Since the Scoping Report is not addressed directly to the appellant and does not imply any specific orders with regard to its medicinal product, it does not qualify as a decree in the sense of Article 5 APA and can therefore not be the object of an appeal. For the full decision, see here.