1 May 2026

In its judgment of 1 May 2026, the Federal Administrative Court (FAC, the Court) upheld the appeal of Apotheke A. AG against the Federal Office of Public Health (FOPH) and annulled the FOPH's decision to delete Chapter 70.02 of the List of Pharmaceutical Specialties (SL), referring the matter back to the FOPH for a new decision following a proper administrative procedure.

The case concerned the FOPH's letter of 13 April 2021, by which it had informed providers of specific immunotherapeutics billed under Chapter 70.02 of the SL that the chapter would be deleted as of 1 January 2023. The FOPH had found that unlicensed but authorisation-required finished medicinal products were being unlawfully declared as formulae magistrales under Chapter 70.02, and that this designation did not correspond to the legal definition of formula magistralis under the Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA), as the products were manufactured on a semi-industrial scale according to predefined specifications rather than individually for each patient. Following a referral by the Federal Supreme Court (9C_575/2022 of 5 July 2023), which had held that the FOPH's communication constituted an appealable general ruling, the court examined the appeal on the merits.

The Court found that the FOPH had committed a grave violation of Apotheke A. AG's right to be heard: it had not involved the appellant in the proceedings prior to issuing its ruling, had failed to conduct the required fact-finding under art. 12 of the Federal Act of 20 December 1968 on Administrative Procedure (APA), and had denied access to the relevant files. The court held that this violation could not be cured on appeal, as the complete absence of prior fact-finding and the total denial of file access amounted to a fundamental hollowing-out of the appellant's procedural rights – a defect too serious to be remedied, particularly given the FOPH's role as a specialist authority with technical discretion.

For more information, see here.