Facts

The appellant, a pharmaceutical company (A. SA), filed an application with the Federal Office of Public Health (FOPH) for the issuance of an order pursuant to Art. 25a APA. The subject of the application was the initiation of a formal administrative procedure within the framework of a Health Technology Assessment (HTA) to review the effectiveness, appropriateness and economic efficiency (WZW) of a medicinal product it distributed. The FOPH rejected the application by not addressing the appellant’s request for the issuance of an order. The appellant appealed this decision before the Federal Administrative Court, which dismissed the appeal. Against this decision, the appellant filed an appeal in public law matters with the Swiss Federal Supreme Court (case file 9C_474/2019 of 6 November 2019).

The HTA was conducted as part of the programme «Re-evaluation of services under the compulsory health insurance (OKP)» of the FOPH. The aim of the programme was the systematic review of potentially obsolete services under the OKP with a view to their removal from the list of services or a restriction of the obligation to reimburse («disinvestment»). The HTA procedure comprised several phases, including topic identification, scoping, assessment and appraisal, and concluded with a recommendation to the Federal Department of Home Affairs (FDHA) or the FOPH regarding a possible deletion, restriction or continuation of the obligation to provide the service. The appellant participated as a stakeholder in the procedure and was able to express its views at various stages. A formal review procedure pursuant to Art. 65 et seq. HIO had not yet been initiated at the time of the appeal.

Considerations

The Federal Supreme Court first examined whether the HTA procedure qualified as an administrative procedure within the meaning of Art. 1 para. 1 APA. It found that an administrative procedure must be aimed at the issuance of an order and must provide for formal participation rights of those affected. The HTA procedure, however, serves exclusively to prepare a basis for decision-making and to issue a recommendation. It constitutes an informal preliminary stage that does not necessarily lead to a formal review procedure pursuant to Art. 65 et seq. HIO. In the absence of an order objective and lacking legal effects vis-à-vis those affected, the HTA procedure is not an administrative procedure within the meaning of the APA (paras. 4.1 and 4.3.2).

The Federal Supreme Court then examined whether the appellant had a claim to the issuance of an order pursuant to Art. 25 or 25a APA. Art. 25 APA grants a claim to the issuance of a declaratory order if a legitimate interest can be demonstrated. Art. 25a APA provides that those affected may request the authority to refrain from, discontinue or remedy unlawful actions or to establish their unlawfulness. Both provisions, however, require the existence of a subject-matter capable of being the subject of an order, i.e. that the authority’s action is aimed at the issuance of an order and produces direct legal effects (paras. 4.2 and 4.3.1).

In the present case, the HTA procedure neither resulted in a subject-matter capable of being the subject of an order nor in direct legal effects for the appellant. The FOPH did not issue any binding sovereign acts but merely prepared a basis for decision-making. A formal review procedure pursuant to Art. 65 et seq. HIO had not yet been initiated, so it remained uncertain whether the HTA…