The complainant contests the breach of important formal regulations.
- The respondent made use of an assessor who was prejudiced and in no way neutral. Because the decision of the Commission is exclusively based on the judgement of the assessor, it should be declared null and void.
- The complainant further grounds this claim on the fact that, in making its decision about qualification for recognition of Orphan Drug Status, the Commission made unjustifiably excessive demands of the documentation and the studies than is the case in other proceedings. Thereby the demands made in these proceedings are also not consistent with criteria for the designation as a medicament for rare diseases in EC No. 141/2000 Art. 3.