Decision 2C_537/2022 of 25 January 2024

22 mars 2024 – In its decision of 25 January 2024, the the Federal Supreme Court rejected the appeal of A. SA concerning limitation of the authorisation of the medicinal product B. to the treatment of spasticity following a stroke or in multiple sclerosis. Contrary to the appellant's assertion, the studies had been thoroughly examined and valued in the judgment of the Federal Administrative Court.

A. SA manufactures the medicinal product B., which has been approved in Switzerland since 1966 for the treatment of muscle spasms in painful skeletal muscle disorders. Swissmedic had restricted the marketing authorisation of B. to the treatment of spasticity following a stroke or in multiple sclerosis, ordered a corresponding adjustment to the specialist and patient information and found a breach of the reporting obligations.

The Federal Administrative Court partially upheld A. SA's appeal and annulled the contested decision only insofar as Swissmedic found a breach of the notification obligation. In 2020, the Federal Supreme Court referred the case back to the Federal Administrative Court for a new decision, holding that the Federal Administrative Court had fallen short of its cognizance by not sufficiently assessing and reviewing the appellant’s objections with regard to the criticism of the individual studies, but had merely relied on Swissmedic’s assessment.

In 2022, the Federal Administrative Court again annulled the contested decision insofar as Swissmedic found a breach of the reporting obligation. Otherwise, it dismissed the appeal again. In the present appeal to the Federal Supreme Court, A. SA requested the annulment of the Federal Administrative Court's judgment of 2022 and demanded an adjustment of the approval restriction for B. as well as corresponding specialist and patient information. The Federal Supreme Court found that this time, the studies had been extensively discussed and evaluated in the Federal Administrative Court's judgment. It held that the Federal Administrative Court did not violate the appellant's right to present arguments and evidence. The appeal was therefore rejected.

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