Federal Administrative Court, Decision C-2161/2017 of 6 June 2019

26 June 2019 – In a recent decision, the Federal Administrative Court held that a marketing authorization holder of medicines (the Appellant) is not entitled to be granted party status in a Health Technology Assessment (HTA) procedure of the Federal Office of Public Health (FOPH). In HTA procedures, the FOPH re-evaluates the effectiveness of potentially obsolete medicines with the aim of removing them from the list of specialities or limiting the indications subject to reimbursement. According to the Court, the aim of an HTA proceeding is to prepare information for health policy decisions on a scientific, independent and patient-oriented basis. An HTA report should be up to date and comprehensively present the advantages and disadvantages of a medical technology. The Court held that the introduction and conduct of this procedure had no direct influence on the rights of the Appellant. The HTA report may serve as a basis for a decision in any later proceedings concerning limitation or deletion from the list of specialities. However, the Appellant would be compulsorily involved in such proceedings and would thus have the opportunity to comment on the corresponding HTA report. The Appellant therefore had no legal interest in participating in the HTA proceeding as a party.