Federal Administrative Court, Decision C-1050/2020 of 5 October 2021

29 October 2021 – In the present case, it was disputed and had to be examined whether Swissmedic was right to reallocate a medicinal product of the appellant from dispensing category C to dispensing category B. Materially, the court had to decide whether the conditions of Art. 42 lit. c Ordinance on Medicinal Products were met, namely whether the medicinal product in question was frequently not used as intended (abuse) and whether such a use could directly or indirectly endanger health. The WHO qualifies as abuse the use of a substance for a purpose not consistent with legal or medical guidelines, as in the non-medical use of prescription medications. According to the court, frequency, for its part, is given in any case when the fact in question can be qualified as notorious, meaning that it is obvious and generally known. According to the case law of the Federal Supreme Court, the relevant technical literature and professional information have the status of notorious facts. Moreover, in the present case, studies and publications illustrated the great potential for abuse of one of the substances contained in the medicinal product in question (FDA warnings on the abuse, important number of cases of attempted suicide with the substance, warning of the Deutsche Apotheker Zeitung, 26 relevant publications on the abuse submitted by Swissmedic, YouTube videos on the abuse etc.). The court further added that there was most likely a high number of unreported cases of abuse. Therefore, the court concluded that there had been and still was frequent abuse and the medicinal product thus fulfilled the conditions for a reclassification into the category B.

Consequently, the court dismissed the appeal.

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