Reclassification of dextromethorphan-containing medicinal products into dispensing category B due to frequent non-intended use; dismissal of the appeal of the marketing authorisation holder

Facts

Parties and procedural history: The appellant, [A. SA] as marketing authorisation holder, lodges an appeal in public law matters against the judgment of the Federal Administrative Court, Division III, dated 24 September 2021 (judgment A-5010/2019). In the lower instance she was unsuccessful against the decision of Swissmedic (Swiss Agency for Therapeutic Products, hereinafter: the Institute) dated 28 August 2019.

Subject matter of the dispute (object): Reclassification of medicinal products (reclassification of medicinal products from dispensing category C into dispensing category B or D).

Facts: The appellant is the marketing authorisation holder of four medicinal products ([B.] , [C.] , [D.] and [B.] ), all containing the active ingredient dextromethorphan and previously belonging to dispensing category C. With the revision of the therapeutic products law effective 1 January 2019, dispensing category C was abolished, which made a new classification necessary. In preliminary notices dated 30/31 January 2019, the Institute envisaged reclassification into dispensing category B. In her statement dated 29 April 2019, the appellant requested classification into dispensing category D. By decision dated 28 August 2019, the Institute reclassified the medicinal products into dispensing category B, rejected the requests, obliged the appellant to adapt the product information within one year and to submit an application for warnings regarding the potential for dependence and abuse by 28 October 2019.

Submissions of the appellant before the Federal Supreme Court: Violation of the right to be heard (insufficient reasoning; lack of legal basis in the decision; lack of scientific evidence for the frequency of abuse, the Institute having relied only on 'easily findable internet pages'); manifestly incorrect establishment of facts regarding the frequency of non-intended use (Art. 42 let. c TPO); legally: reclassification into category B justified only in case of increased risk.

Requests: Annulment of the judgment of the lower instance and classification into dispensing category D; in the alternative, remittal to the Institute. The Institute requested dismissal; the Federal Administrative Court waived its statement. Suspensive effect was granted by presidential order dated 22 November 2021.

Considerations

Admissibility: The appeal in public law matters is admissible against decisions of the Federal Administrative Court in the field of health law (Art. 84 para. 1 THPA; Art. 82 let. a, Art. 86 para. 1 let. a, Art. 90 FSCA). The appeal was filed in due form and time (Art. 42, Art. 100 para. 1 FSCA) and was lodged by the legitimised appellant (Art. 89 para. 1 FSCA). The Court therefore enters into the matter.

Complaint regarding the right to be heard: The right to be heard (Art. 29 para. 2 Cst.) includes the duty to give reasons. The Institute's decision indeed does not name the legal bases for the reclassification, but the guiding considerations (abuse potential of dextromethorphan, lack of suitability for facilitated self-medication) are stated. The appellant was therefore able to contest the decision appropriately before the Federal Administrative Court; no violation of the right to be heard exists. The objection that the frequency of abuse was not scientifically substantiated concerns, according to the Federal Supreme Court, the establishment of facts and is examined under E. 6.

Establishment of facts: The Federal Supreme Court bases its decision on the facts established by the lower instance (Art. 105 para. 1 FSCA) and departs from them only if they are manifestly incorrect and the correction may be decisive for the outcome (Art. 97 para. 1 FSCA). The lower instance based the frequent non-intended use on numerous scientific publications, internet information, specialist articles, news reports, experience reports and video documentation. The objections against the WHO report (2012) do not succeed, as it does not exclude the frequency and only considers international control as not indicated. The statistics of Tox Info Suisse were comprehensibly assessed by the lower instance as an unsuitable indicator, since only mono-intoxications and telephone enquiries are recorded and reporting obligations exist only for specialist persons. The publication by Williams et al. (2019) demonstrates a decline but does not exclude continued frequent use; dextromethorphan was in 2018 the most consumed substance among the party drugs examined. The appellant does not explain why the conclusions should be manifestly untenable; her criticism is purely appellate in nature. The Federal Council's Dispatch on the revision of the Therapeutic Products Act (FF 2013 43, section 1.4.5) moreover expressly names dextromethorphan as an example of a substance in dispensing category B.

Legal bases of the classification: The…