Action brought on 11 September 2020 — Kedrion v EMA

(Case T-570/20)

(2020/C 371/30)

Language of the case: Italian

Parties

Applicant: Kedrion SpA (Barga, Italy) (represented by: V. Salvatore, lawyer)

Defendant: European Medicines Agency

Form of order sought

The applicant claims that the Court should:

— annul the contested decision; and

— order the European Medicines Agency to pay the costs incurred by the applicant in the present proceedings.

Pleas in law and main arguments

The present action has been brought against the decision refusing the applicant’s confirmatory application for access to documents, adopted by the European Medicines Agency under Article 8 of Regulation (EC) No 1049/2001 of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (doc.: EMA/336464/2020) (1). The application concerned documents submitted by a new service provider in respect of the collection and fragmentation of plasma in Italy, provided by Italian centres.

In addition to the reasons for refusing access to the requested documents, which had already been set out in the decision refusing the original application and were reiterated in part in the contested decision, EMA further stated that the refusal to grant access had to be considered justified in view of the fact that the document requested contains information also included in form 3.2.S of the request for marketing authorisation (MA) for a medicinal product as well as information concerning contractual arrangements and agreements between the holder of the PMF (Plasma Master File) and the centres, therefore stressing the need to protect such information in so far as it is classified as commercially sensitive.

In support of the action, the applicant relies on two pleas in law.

1. First plea in law, alleging infringement of Article 4(2) of Regulation (EC) No 1049/2001 — The applicant submits in this regard that the right of access to documents is one of the means by which the principle of transparency — one of the fundamental principles on which the European Union itself is founded, to the extent that it is stated in the first article of the Treaty on European Union — is put into effect and guaranteed. As a result, the institution to which the application was made cannot merely state that it does not grant access to the document because it contains confidential information; instead it must conduct a detailed and accurate examination of its contents in order to allow access to the document after any parts or pieces of information considered commercially sensitive have been redacted in order to protect their confidentiality. The Agency may not generically rely on the protection of business arrangements or agreements which may be reflected in the PMF, expressing fears of detriment to the holder’s interests, where that objection is irrelevant as regards the application for access to the part of the document which contains the list of collection centres.

2. Second plea in law, alleging that the contested decision is unlawful on account of a misuse of powers, a lack of reasoning and illogical and contradictory reasoning. — The applicant submits in this regard that Article 4(2) of Regulation No 1049/2001 provides that, even where the document requested contains commercially sensitive information, access may be permitted where there is an overriding public interest in disclosure of the information contained therein. In that regard, the defendant, invoking case-law, states that it is for the applicant to refer to specific circumstances to establish an overriding public interest which justifies the disclosure of the documents containing commercially sensitive information. However, that cannot (i) exempt the institution to which the application was made from recognising an overriding public interest justifying the disclosure of the document when it is easily recognisable, or (ii) justify the conclusion, in respect of the circumstances referred to by the applicant, based on the observation that since these were not the findings from inspections carried out in the past it must be held that the changeover between undertakings involved in the management of the service of collecting plasma produced from blood banks, as well as the production, storage and delivery of medicinal products derived from plasma, can occur smoothly without undermining the public interest.

(1) OJ 2001 L 145, p. 43.