Federal Administrative Court, Decision C-642_2018 from 20 January 2022

15 février 2022 – In this case, the appellant claimed that the Federal Office of Public Health (FOPH) had violated federal law by limiting the therapeutic cross comparison (TQV) to one class of active ingredients and by excluding the medicinal product F. According to the appellant, the medicinal product F was unjustifiably excluded from the TQV, although it was indicated for the treatment of the same disease and therefore constituted an alternative therapy.

The Court reaffirmed that each medicinal product must be reviewed separately. It held that the formation of fixed groups of comparable medicinal products that are always subjected to the same TQV is neither provided for in the law nor in the relevant regulations, nor can it be derived from the principle of equality or the prohibition of arbitrariness. On the contrary, the relevant legal bases require that each individual medicinal product must fulfill the conditions to be included in the list of specialties. The requirements relate to individual and not to groups of interconnected medicinal products.

In conclusion, the Court decided that it was within the discretion of the FOPH to include only the medicinal products D and E in the TQV and to disregard the medicinal product F. Therefore, the appeal was dismissed.

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