ORDER OF THE PRESIDENT OF THE FIFTH CHAMBER OF THE GENERAL COURT
4 January 2023 (*)
(Intervention – Time limit – Interest in the result of the case)
In Case T‑416/22,
Fresenius Kabi Austria GmbH, established in Graz (Austria), and the other applicants whose names are listed in the annex, (1) represented by W. Rehmann and A. Knierim, lawyers,
applicants,
v
European Commission, represented by M. Escobar Gómez and A. Sipos, acting as Agents,
defendant,
supported by
Ireland, represented by A. Joyce and M. Tierney, acting as Agents,
intervener,
makes the following
Order
Facts and procedure
1 On 24 May 2022, the European Commission adopted Implementing Decision C(2022) 3591 final concerning, in the framework of Article 107p of Directive 2001/83/EC of the European Parliament and of the Council, the marketing authorisations for medicinal products for human use which contain the active substance ‘hydroxyethyl starch (HES), solutions for infusion’ following an assessment of a post authorisation safety study (‘the contested decision’).
2 On 1 July 2022, Fresenius Kabi Austria GmbH and the other applicants whose names are listed in the annex brought an action for annulment under Article 263 TFEU against the contested decision.
3 On 5 September 2022, in accordance with Article 79 of the Rules of Procedure of the General Court, a notice was published in the Official Journal of the European Union (OJ 2022 C 340, p. 49).
4 By document lodged at the Court Registry on 26 October 2022, the European Medicines Agency (EMA) applied for leave to intervene in support of the form of order sought by the Commission. The application to intervene was served on the parties in accordance with Article 144(1) of the Rules of Procedure of the General Court.
5 By document lodged at the Court Registry on 17 November 2022, the applicants argued that the EMA’s application to intervene was lodged out of time. The applicants stated that they had no further observations given that the application to intervene should be dismissed as inadmissible.
6 By document lodged at the Court Registry on 23 November 2022, the Commission informed the Court that it had no objections to the EMA’s application to intervene.
Law
7 In accordance with Article 144(5) of the Rules of Procedure, where an application to intervene is submitted on a legal basis other than the first paragraph of Article 40 of the Statute of the Court of Justice of the European Union, the President is to decide on the application to intervene as soon as possible, by order.
The application to intervene
8 First of all, the applicants argue that the EMA’s application to intervene was lodged after the expiry of the period of six weeks from the date of publication of the notice in the Official Journal and should therefore be regarded as out of time.
9 In that regard, it should be recalled that, under Article 143(1) of the Rules of Procedure, an application to intervene is to be submitted within six weeks of the publication referred to in Article 79 of those rules. That period is to be extended on account of distance by a single period of 10 days provided for in Article 60 of the Rules of Procedure.
10 In the present case, since the notice in the Official Journal referred to in Article 79 of the Rules of Procedure was published on 5 September 2022, the period for submitting an application to intervene expired on 27 October 2022. The EMA’s application to intervene was lodged at the Court Registry on 26 October 2022 and therefore within the time limits laid down by the provisions of that regulation referred to above.
11 Consequently, the applicants’ argument that the application to intervene should be regarded as out of time must be rejected.
12 Moreover, under the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, which is applicable to proceedings before the General Court pursuant to the first paragraph of Article 53 of that statute, any body, office or agency of the European Union which can establish an interest in the result of a case is entitled to intervene in that case.
13 In accordance with the settled case-law of the Court of Justice, the concept of ‘an interest in the result of a case’, within the meaning of the second paragraph of Article 40 of the Statute of the Court of Justice of the European Union, must be defined in the light of the subject matter of the dispute and be understood as meaning a direct, existing interest in the ruling on the form of order sought, and not as an interest in relation to the pleas in law or arguments put forward. The words ‘result of a case’ refer to the final decision sought, as set out in the operative part of the future judgment. In principle, an interest in the result of the case can be regarded as sufficiently direct only in so far as that result is capable of altering the legal position of the applicant for leave to intervene (see order of the President of the Court of Justice of 22 September 2022, Mylan IRE Healthcare v Commission, C‑237/22 P, not published, EU:C:2022:726, paragraph 14 and the case-law cited).
14 However, it should be pointed out that the bodies, offices and agencies of the Union, unlike natural and legal persons, are likely to apply for leave to intervene in a case before the Court of Justice not to defend private interests or, as in the case of associations, interests connected with the objects set out in their statutes, such as environmental protection for example, but rather where, as in the present case, the measure giving rise to the dispute was adopted following a procedure in which the body, office or agency in question was called upon to participate, in order to defend the opinion it had issued or the assessments it had made in the course of that procedure (see order of the President of the Court of Justice of 22 September 2022, Mylan IRE Healthcare v Commission, C‑237/22 P, not published, EU:C:2022:726, paragraph 15 and the case-law cited).
15 Thus, as regards applications to intervene in a case concerning the annulment of an EU measure submitted by bodies, offices and agencies of the Union such as the EMA, the requirement that the relevant body, office or agency should have a direct and existing interest in the result of the case should be regarded as having been met, inter alia, if it is able to establish that the EU measure at issue was adopted following a procedure in which, in accordance with EU law, its participation is envisaged through, as the case may be, the adoption of opinions or the carrying out of assessments (see, to that effect, order of the President of the Court of Justice of 22 September 2022, Mylan IRE Healthcare v Commission, C‑237/22 P, not published, EU:C:2022:726, paragraph 17).
16 That is the case here. The Commission adopted the contested decision, providing for the suspension by the Member States of the European Union of national marketing authorisations for the medicinal products listed in Annex I to that decision, in the framework of an assessment of a post-authorisation safety study in accordance with Article 107p and Article 107q of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67), as amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 as regards pharmacovigilance (OJ 2010 L 348, p. 74) (‘Directive 2001/83’). As is apparent from recitals 2 to 4 of the contested decision, in the procedure leading to its adoption, the Pharmacovigilance Risk Assessment Committee of the EMA (‘PRAC’), in its assessment report of 10 February 2022 on the basis of Article 107q(1) of Directive 2001/83/EC, recommended such a suspension.
17 Consequently, the EMA’s application for leave to intervene must be granted.
Costs
18 Under Article 133 of the Rules of Procedure, a decision as to costs is to be given in the judgment or order which closes the proceedings. The present order does not close the proceedings either as regards the EMA or in relation to the other parties. The costs must therefore be reserved.
On those grounds,
THE PRESIDENT OF THE FIFTH CHAMBER OF THE GENERAL COURT
hereby orders:
1. The European Medicines Agency (EMA) is granted leave to intervene in Case T‑416/22 in support of the form of order sought by the European Commission.
2. The Registrar shall send to the EMA a copy of every procedural document served on the main parties.
3. A period shall be prescribed within which the EMA may submit a statement in intervention.
4. The costs are reserved.
Luxembourg, 4 January 2023.