Facts
The company [S. AG] markets the product [O.], which was included in the Speciality List (SL) in 1977. In 1983, the Federal Office for Social Insurance (BSV) requested the company to submit clinical studies on the product, as the Federal Medicines Commission (EAK) had decided to review the cerebral-vasoactive medicinal products. A working group of the EAK, consisting of Professors [S.], [R.] and F., evaluated the submitted studies and categorized the products according to their efficacy. The product [O.] was classified in category C (insufficient efficacy). The BSV then informed the company [S. AG] of the intended delisting of the product from the SL.
The company [S. AG] filed a complaint against the delisting decision with the Federal Department of the Interior (EDI). Among other things, it criticized the lack of impartiality of Professor [R.], who was a member of the evaluating working group. His son was the head of the research laboratory of a competitor company of S. AG. The EDI dismissed the complaint.
The company [S. AG] then filed an administrative court appeal with the Federal Insurance Court. The court upheld the appeal and revoked the decision of the EDI as well as the delisting decision of the BSV. It justified this by stating that the involvement of Professor [R.] in the EAK working group gave the appearance of bias, as his son was employed by a competitor company. This mere appearance of bias was sufficient to consider the company S. AG's right to an impartial composition of the deciding administrative authority as violated.
Considerations
The Federal Insurance Court stated that although the members of the EAK are not subject to the special recusal regulations for judges, they must comply with the general recusal rules of administrative law according to Article 10 paragraph 1 of the Federal Act on Administrative Procedure (VwVG). Accordingly, persons involved in preparing a decision must recuse themselves if there are…