Language of document :

Action brought on 27 November 2012 - Spirlea v Commission

(Case T-518/12)

Language of the case: German

Parties

Applicants: Darius Nicolai Spirlea (Capezzano Pianore, Italy) and Mihaela Spirlea (Capezzano Pianore) (represented by: V. Foerster and T. Pahl, lawyers)

Defendant: European Commission

Form of order sought

The applicants claim that the General Court should:

accept the present application made on the basis of Article 263 TFEU;

declare the action admissible;

declare the action to be founded and, accordingly, that the defendant committed significant procedural errors and made other substantive errors of law;

on that basis, annul the Commission's decision of 27 September 2012 to bring an end to EU pilot procedure No 2070/11/SNCO (Ref. Ares [2012] 1135073);

order the defendant to pay the costs.

Pleas in law and main arguments

In support of the action, the applicants rely on three pleas in law.

First plea in law: setting up an EU pilot procedure without any legal basis (Articles 290 and 291 TFEU)

In the context of this plea, the applicants submit that the launching of an EU pilot procedure amounts to an additional procedural requirement to Article 258 TFEU. This procedural requirement - for which the Commission does not have any power or delegated power under the Treaties - has been used contrary to the rule of law and in a non-transparent procedure which, moreover, undermines the procedure for failure to fulfil obligations laid down in Article 258 TFEU.

Second plea in law: infringement of the Commission communication of 20 March 2002 to the European Parliament and the European Ombudsman on relations with the complainant in respect of infringements of Community law. 2

In this regard, the applicants submit that the Commission arbitrarily bypassed its communication on relations with the complainant in respect of infringements of Community law and, without offering any alternative, transferred the applicants' complaints to the EU pilot procedure, the rules of which are not accessible to the applicants.

Third plea in law: infringement of the duty to state reasons

In this context, they complain that the Commission's grounds do not contain any clarification of the facts in relation to the application of Regulation (EC) No 1394/2007  and do not address the specific legal complaints made by the applicants in connection with EU law.

____________

1 - OJ 2002 C 244, p. 5.

2 - Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ 2007 L 324, p. 121).