Federal Supreme Court, Decision 2C_697/2021 from 28 July 2022
2 settembre 2022 – In the present decision, the Federal Supreme Court (hereinafter the Court) had to assess whether certain medicinal products that used to fall under category without prescription (category C), are now to be classified in category B or D. They also examined, if the facts that led the Federal Administrative Court (FAC) to their conclusion, had been established in a manifestly incorrect or incomplete manner.
The complainant is the owner of medicinal products that contain dextromethorphan. These had previously been classified in category C, which was removed with the revision of the Therapeutic Products Act as of January 1, 2019. Thus, a new classification became necessary. According to Art. 42 lit. c of the Ordinance on Medicinal Products a product is classified in the category of prescription drugs (category B), if it is frequently used for purposes other than those for which it is intended, and this may directly or indirectly endanger health. After a careful evaluation of scientific publications, media articles and expert literature the Court concluded that it was not obviously wrong for the FAC to assume that there was a frequent use of dextromethorphan that was not in accordance with its intended purpose.
Regarding the legal assessment for the reclassification of medicinal products from category C, the Court summarised the following: According to the dispatch on the amendment of the Therapeutic Products Act most of the medicinal products from category C are to be reclassified to category D. Category D covers medicinal products which may be dispensed without a prescription but only after specialist consultation. However, all preparations that cannot be reallocated to category D for safety reasons, should be assigned to category B in which case pharmacists can dispense the products independently without a prior medical prescription. The Court concludes that there is no reason to only reclassify to category B if the risks have increased.
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