Facts
Parties and proceedings: [A. AG] (appellant) is the holder of the medicinal products [B.] , all of which contain the active ingredient dextromethorphan. The respondent is the Swiss Agency for Therapeutic Products Swissmedic (the Institute). The lower instance was the Federal Administrative Court, Division III (judgment C-5008/2019 of 14 July 2021).
Background: The medicinal products were classified in dispensing category C. This category was abolished with the revision of the Therapeutic Products Act effective 1 January 2019, which made a reclassification necessary.
Administrative proceedings: By means of three preliminary decisions of 30 January 2019, the Institute indicated its intention to reclassify the products into dispensing category B. On 29 April 2019 the appellant requested classification in dispensing category D and an adjustment of the professional and patient information. By decision of 28 August 2019, the Institute reclassified the medicinal products into dispensing category B, combined with conditions requiring the adjustment of the information texts within one year and the submission of an application for warnings regarding the potential for dependence and abuse by 28 October 2019.
Lower instance: The Federal Administrative Court dismissed the appeal by judgment of 14 July 2021.
Before the Federal Supreme Court: On 13 September 2021 the appellant filed a public law appeal. It requested the annulment of the lower court's judgment and classification in dispensing category D, alternatively remittal to the Institute. The Institute requested dismissal. The Federal Administrative Court waived a statement of position. Suspensive effect was granted by presidential order of 22 September 2021.
Legal question: Whether the medicinal products were rightly reclassified from dispensing category C to dispensing category B (as held by the Institute and the lower court) rather than to dispensing category D (as claimed by the appellant). The appellant further complained of a violation of the right to be heard due to insufficient reasoning and of a manifestly incorrect establishment of facts concerning the frequency of non-intended use.
Considerations
Formal complaint (right to be heard): The appellant complained that the Institute's decision cited no statutory basis for the reclassification and did not scientifically substantiate the frequency of abuse. The Federal Supreme Court holds that the duty to give reasons, as a component of Art. 29 para. 2 Cst., requires that the affected party be able to challenge the decision appropriately and that the authority at least briefly state the guiding considerations. The object of the challenge here is the decision of the Federal Administrative Court. Even though the decision does not cite statutory bases, it states the Institute's considerations (abuse potential of dextromethorphan, lack of suitability for simplified self-medication). The appellant was therefore able to challenge the decision appropriately. There is no violation of the right to be heard. According to the Federal Supreme Court, the complaint that the frequency of abuse was not scientifically substantiated concerns the establishment of facts and is examined in connection with the substantive complaint.
Legal framework: The determinative provisions are the TPA in the version effective 1 January 2019 and the TPO. Dextromethorphan is not subject to narcotics control. Classification is carried out by the Institute (Art. 40 para. 1 TPO), taking into account the professional competence of the professional groups (Art. 23a para. 1 TPA) and the criteria of Art. 40 para. 2 TPO, in particular abuse potential (let. e). Under Art. 42 let. c TPO, dispensing category B applies if a medicinal product is frequently used non-intendedly and this may directly or indirectly endanger health. Dispensing category D (Art. 43 TPO) presupposes that the medicinal product does not fall under A or B and requires specialist advice. Category B medicinal products that were in category C until 1 January 2019 and are newly classified into B belong to the medicinal products designated by the Federal Council under Art. 24 para. 1 let. a no. 1 TPA (Art. 45 para. 1 let. c TPO), provided there is abuse potential (Art. 45 para. 1 let. c TPO).
Complaint regarding the establishment of facts (frequent non-intended use): The lower court based the frequent non-intended use on numerous scientific publications, internet information, specialist articles, news reports and experience reports, according to which dextromethorphan is abused as a recreational drug (DXM). The Federal Supreme Court holds that the appellant did not manage to show that the establishment of facts was arbitrary; it confined itself to appellate-style criticism. The WHO report (35th report, Technical Report Series 973, 2012) concerns a possible international control and does not argue against frequent abuse. The data of Tox Info Suisse only capture mono-intoxications and…