EN Official Journal of the European Union C 55/27

Action brought on 23 December 2010 — Octapharma Pharmazeutika v EMA

(Case T-573/10)

2011/C 55/49

Language of the case: German

Parties

Applicant: Octapharma Pharmazeutika Produktionsgesellschaft mbH (Vienna, Austria) (represented by: I. Brinker, T. Holzmüller and Professor J. Schwarze, lawyers)

Defendant: European Medicines Agency

Form of order sought

— Annul the note of the European Medicines Agency (EMA) to the applicant of 21 October 2010, in so far as the recovery of excess fees amounting to EUR 180 700 was refused;

— Order the defendant to pay the costs of the proceedings in accordance with Article 87(2) of the Rules of Procedure of the General Court.

Pleas in law and main arguments

In support of its action, the applicant raises four pleas in law.

1. First plea: Infringement of the principle that the administration must act lawfully in conjunction with the legal rules applicable to the charging of fees

In that regard, the applicant claims that EMA refused the recovery of fees on the basis of an unlawful fee regulation issued by it. EMA exceeded its margin of appreciation, in so far as it based the contested decision on a fee regulation which infringes specific and general principles of fee calculation. The applicant claims that the fee regulation is in particular not covered by Regulation (EC) No 297/95 (1). The fee charged infringes the principles of adequate and moderate fee charging. Furthermore, it is clearly disproportionate to the fees charged for initial certification, annual re-certification and established administrative procedure.

2. Second plea: Infringement of the principle of proportionality

The applicant claims that there is an infringement of the principle of proportionality in the comparison with the fees for the other services offered by EMA. Although other certifications for plasma master files would involve a similar or greater administrative burden, significantly lower fees were fixed in relation to them. It is also apparent from a comparison with recent fee practice with regard to the administrative services accounted for here that the fee charged is disproportionate to the resulting burden.

3. Third plea: Infringement of the principle of the protection of legitimate expectations with regard to sudden changes in administrative behaviour

The applicant claims in the context of the third plea that EMA suddenly changed its fee practice in a way that was not foreseeable for the applicant and the other affected parties, and thereby infringed the principle of the protection of legitimate expectations. In particular, the defendant disregarded the applicable legal framework and its margin of appreciation in the calculation of the fees, so that the applicant can rely on the protection of its legitimate expectations. In the opinion of the applicant, it is particularly detrimental in that respect that EMA reverted to the old fee practice even before issuing the contested decision.

4. Fourth plea: Infringement of the duty of fair and consistent administration

The applicant claims in this respect that the sudden fee increase breaches the duty of fair and consistent administration codified in the ‘Commission Code of good administrative behaviour for staff of the European Commission in their relations with the public’ and resulting from the right to good administration in accordance with Article 41 of the Charter of fundamental rights of the European Union. In established EMA fee practice, there would otherwise be a significantly lower fee charged for the same administrative burden, based on a different method of calculation. It follows that the present case concerns an unjustified change in administrative behaviour. Moreover, the applicant claims that, in the light of the special temporal circumstances and the additional burden in comparison with the previous years, EMA should have responded to the applicant’s case at least by way of an exceptional or transitional regulation.

(1) Council Regulation (EC) No 297/95 of 10 February 1995 on fees payable to the European Agency for the Evaluation of Medicinal Products (OJ 1995 L 35, p. 1).