Federal Supreme Court, Decision 2C_740/2021 from 17 May 2022

6 luglio 2022 – In the present decision, the Federal Supreme Court had to decide whether the reclassification of medicinal products containing codeine from dispensing category C to dispensing category B was lawful. Swissmedic had reclassified the medicinal products based on the guarantee of the specialist advice required for safe use. The lower court (the Federal Administrative Court) dismissed the appeal against Swissmedic’s decision.

From a material point of view, the Federal Supreme Court (hereinafter the Court) had to assess whether the medicinal products should have been reclassified from the former dispensing category C to dispensing category B, as ordered by Swissmedic and confirmed by the lower court, or to dispensing category D, as argued by the complainant. The assessment of this question was primarily based on the relevant provisions of the Therapeutic Products Act (TPA) and the Ordinance on Medicinal Products (Arzneimittelverordnung, VAM). As the medicinal products concerned contained the morphine derivative codeine, the Narcotics Act (NarcA) also had to be observed. The Court considered that, according to the conception of the NarcA, druggists were not allowed to dispense narcotics to patients, especially since Art. 9 NarcA provides for such dispensing only by medical personnel and responsible managers of public or hospital pharmacies. However, the reclassification of the medicinal products to dispensing category D would have meant that they could also have been dispensed by druggists. In the interest of concordance between the provisions of narcotics law and those of therapeutic products law, the Court concluded that Art. 9 NarcA precluded the assignment of the medicinal products in dispute in that case to dispensing category D, regardless of how these medicinal products would have been classified from a purely therapeutic products law perspective.

Therefore, the Court ruled that narcotics law precludes the reclassification of codeine-containing medicinal products to dispensing category D. It was therefore unobjectionable under narcotics and therapeutic products law that the lower court protected the reclassification of the medicinal products in dispute to dispensing category B. The Court therefore dismissed the appeal.

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