Vifor (International) Ltd., the marketing authorisation holder for the iron preparation Venofer, challenged a decision by the Federal Office of Public Health (FOPH) which, in its 2022 triennial review, imposed both a price reduction and a new reimbursement limitation on Venofer under the List of Pharmaceutical Specialties (Spezialitätenliste, SL) scheme. While Vifor (International) Ltd. did not contest the price reduction, it appealed the imposition of the limitation, alleging procedural irregularities during the administrative review, including inadequate access to the case file and deficient safeguarding of its right to be heard. The matter was brought before the Federal Administrative Court, where Vifor (International) Ltd. also sought broad anonymisation of the published judgment to protect confidential business information.

The Federal Administrative Court scrutinised Vifor (International) Ltd.’s allegations of breaches of the right to be heard, particularly focusing on the FOPH’s obligations regarding proper case management and disclosure. The Court found that the FOPH had failed to keep the administrative files for Venofer and a related product, Ferinject, sufficiently distinct, and thus did not provide Vifor (International) Ltd. full and clear access to the relevant records for Venofer. This deficiency amounted to a breach of the statutory right to inspect all material case documents, which forms a core element of the right to be heard under Swiss law. Due to this procedural violation, the Court held that any remedy at the judicial stage would not sufficiently cure the defect. As a result, it annulled the limitation imposed on Venofer and remitted the matter to the FOPH to grant Vifor (International) Ltd. proper access to the complete case file and to issue a new decision with full observance of procedural rights. Other substantive arguments, and the dispute over the extent of anonymisation in the published decision, were either addressed only to the extent necessary or left aside as the procedural violation was dispositive.

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