13.2.2017

EN

Official Journal of the European Union

C 46/23

(Case T-875/16)

(2017/C 046/26)

Language of the case: Italian

Parties

Applicant: Falcon Technologies International LLC (Ras Al Khaimah, United Arab Emirates) (represented by: R. Sciaudone and G. Arpea, lawyers)

Defendant: European Commission

Form of order sought

The applicant claims that the Court should:

—order the Commission to produce the final report;

—annul the contested decision; and

—order the Commission to pay the costs.

Pleas in law and main arguments

The present action has been brought against the Commission’s decision of 14 October 2016 by which the Commission rejected the applicant’s confirmatory application for access to the document ‘Final report of an assessment of ICIM (NB 0425), carried out in the framework of the joint assessment process for notified bodies (DG (SANTE) 2015-7552)’.

In support of its action, the applicant relies on the three following pleas in law:

1.First plea in law, alleging infringement of the first indent of Article 4(2) of Regulation No 1049/2001 (1)

In the first place, the applicant criticises the Commission’s incorrect application of the concept of ‘commercial interests’ as referred to in the first indent of Article 4(2) of Regulation No 1049/2001. The decision arising from the final report, adopted at the end of a comprehensive administrative process regarding ICIM’s compliance with the rules — Implementing Regulation (EU) No 920/2013 (2) — applicable to notified bodies, does not contain any information traditionally considered to be commercial. In any event, the alleged reputational damage resulting from disclosure of the final report would not in itself be sufficient to justify applying the derogation referred to in the first indent of Article 4(2) of Regulation No 1049/2001. In the second place, the contested decision does not show clearly, analytically and unequivocally the elements which led the Commission to consider that it would be detrimental to ICIM for FTI to have access to the final report, let alone provide information of the outcome of the weighing of the alleged commercial interests of ICIM and the interests of its commercial partners — including the applicant — in knowing the reliability and credibility of the notified body.

2.Second plea in law, alleging incorrect exclusion of the overriding public interest and incorrect interpretation and application of the last part of Article 4(2) of Regulation No 1049/2001

The contested decision must be annulled in so far as the Commission stated that there was no overriding public interest in disclosure and that there were no other public interests capable of taking precedence over the interests protected by the first indent of Article 4(2) of Regulation No 1049/2001. The applicant submits that, contrary to the case-law in Commission v EnBW (3) the essential nature of the final report for the purposes of judicial protection before the national courts was neglected and was not regarded as an overriding public interest. In any event, the contested decision is also vitiated by the Commission’s failure to regard the protection of competition and of public health as overriding public interests.

3.Third plea in law, alleging incorrect interpretation and application of Article 4(6) of Regulation No 1049/2001

Lastly, the Commission, in breach of the principle of proportionality, did not properly examine the possibility of granting partial access to the final report. The administrative decision taken by the Commission could have been redacted in so far as it contained sensitive or objectively secret data. There was nothing to prevent the preparation of a non-confidential version of the final report which would provide FTI with sufficient understanding of the assessment of ICIM without thereby revealing any (albeit unlikely) commercial secrets which the latter might have.

(1) Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ 2001 L 145, p. 43).

(2) Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (Text with EEA relevance).

(3) See judgment of the Court of Justice of 27 February 2014, Case C-365/12 P, Commission v EnBW, paragraph 107.