Federal Administrative Court, Decision C-447/2019 of 18 May 2021
4. Juni 2021 – In this decision, the Federal Administrative Court had to assess whether the reduction in the public price of the appellant's medicine in the context of the review of the conditions of admission every three years was lawful. The appellant claimed, firstly, that her right to a fair hearing had been violated because the Federal Office of Public Health (FOPH) had referred to the applications of other marketing authorisation holders for inclusion in the SL as (possible) evidence but had not granted her access to these documents as part of the review procedure. Secondly, the appellant complained of a violation of the principle of investigation.
After careful examination, the court held that the FOPH had significantly violated its duty to keep records. In addition, the FOPH failed to observe minimum guarantees of the rule of law in the conduct of the proceedings by relying on information provided by an anonymous expert who was not accessible for review with regard to his qualifications, independence and suitability. The court then stated that, by leaving open the question of whether the appellant's medicine was a patent-protected original preparation, without further clarification and without carrying out any evidentiary measures, the FOPH had violated the principle of investigation and thus federal law in determining the relevant facts. The appeal was therefore upheld.
For more information, see here.