Federal Administrative Court, Decision C-5710/2019 from 24 September 2021 and Decision C-5720/2019 from 24 September 2021

11. November 2021 – In the decisions of the two above-mentioned parallel procedures, the Court had to decide whether Swissmedic had legally exercised its discretion and, in this context, whether the measure taken by it, namely the suspension of the operating license due to the lack of trustworthiness of the responsible person (Art. 17 and 18 of the Medicinal Products Licensing Ordinance) of appellant could have been replaced by a more lenient measure. Swissmedic had suspended the operating license after the responsible person of appellant had been investigated for violations of the Chemicals Act and the Narcotics Act (NarcA). Pursuant to art. 39 para. 3 of the Medicinal Products Licensing Ordinance Swissmedic may suspend the license of a company if a responsible person is under investigation for infringing the Therapeutic Products Act (TPA) or the NarcA. In this context, the court held that the only decisive factor was whether the personal requirement of the responsible person under the provisions of the laws on therapeutic products was impaired by the pending criminal proceedings in which the responsible person was accused of violating the TPA or the NarcA. The seriousness of the offence or an actual conviction did not matter according to the Court. In the case at hand, the Court concluded that based on the facts of the criminal proceedings it was apparent that appellant’s responsible person lacked the trustworthiness needed for his function and thus the conditions for an operating license were not met. The appellant further argued that a shortage of qualified personnel existed. However, according to the Court, such a shortage did not justify employing a person that did not fulfil the conditions of Swiss legislation on therapeutic products as a responsible person. In addition, contrary to appellant’s argumentation, a suspension of the operating license did not require the presence of an immediate health hazard. To conclude, the Court held that the suspension of the operating license in the present case was necessary and that the interest in enforcing the law was more important than appellant's interest in the continuation of the license. The appellant was further not able to establish how the measure taken by Swissmedic was intended to undermine the market economy and thus the Court ruled that no violation of the economic freedom existed in the present case.

Therefore, the Court held that Swissmedic rightfully suspended the operating license of appellant and thus the appeal was rejected by the Court.

For more information, see here (Decision C-5710/2019) and here (Decision C-5720/2019).