Federal Supreme Court Decision 2C_424/2018 of 15 March 2019

22. März 2019 – Contrary to the opinion of Swissmedic, preparations made from cell extracts on prescription by a clinic in the Canton of Appenzell Ausserrhoden are not subject to authorization. The preparations in question are so-called magistral formulas which are produced in a pharmacy in execution of a medical prescription for a specific person or group of persons. According to Article 9(2) of the Therapeutic Products Act (SR 821.21; “TPA”), magistral formulas do not require authorization. In the Ordinance on Medicines (SR 812.212.21), the Federal Council has defined requirements that an active pharmaceutical ingredient must fulfil in order to be used in the manufacture of magistral formulas. These include active pharmaceutical ingredients that are already contained in a medicinal product authorized by Swissmedic or included in the list of homeopathic and anthroposophic therapeutic methods published by Swissmedic. The Federal Supreme Court decided that this regulation has no basis in the TPA. The TPA gives the Federal Council the authority to establish qualitative criteria for medicinal products that are not subject to authorization. However, if a medicinal product does not require authorization by law, Federal Council may not impose the requirement of the active pharmaceutical ingredient contained in the magistral formula being authorized by Swissmedic.