ORDER OF THE PRESIDENT OF THE GENERAL COURT

27 March 2025 (*)

( Interim relief – Access to documents – Regulation (EC) No 1049/2001 – Documents relating to the EMA’s scientific advice given pursuant to Article 57(1)(n) of Regulation (EC) No 726/2004 – Decision to grant a third party access to the documents – Application for suspension of operation of a measure – No urgency )

In Case T‑666/24 R,

Teva Pharma BV, established in Haarlem (Netherlands), represented by C. Lindenthal and A. Säurig, lawyers,

applicant,

v

European Medicines Agency (EMA), represented by G. Gavriilidou, S. Drosos and G. Ramo, acting as Agents,

defendant,

THE PRESIDENT OF THE GENERAL COURT

having regard to the order of 30 December 2024, Teva Pharma v EMA (T‑666/24 R, not published),

makes the following

Order

1        By its application based on Articles 278 and 279 TFEU, the applicant, Teva Pharma BV, seeks suspension of the operation of Decision EMA/391476/2024 Rev.1 of the European Medicines Agency (EMA) of 28 October 2024 granting a third party, under 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), access to a document relating to scientific advice concerning the medicinal product ferric carboxymaltose, subject to certain redactions (‘the contested decision’).

 Background to the dispute and forms of order sought

2        The applicant is a pharmaceutical company established in the Netherlands.

3        On 17 January 2020, the applicant requested scientific advice for the medicinal product ferric carboxymaltose (‘the medicinal product at issue’), a generic version of the medicinal product Ferinject, which is indicated for the treatment of iron deficiencies, pursuant to Article 57(1)(n) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1).

4        On 26 March 2020, the EMA’s Committee for Medicinal Products for Human Use rendered its scientific advice on the medicinal product at issue (‘the scientific advice’).

5        In the light of the conclusions of the scientific advice, in 2022 the applicant submitted an application for marketing authorisation for the medicinal product at issue in a decentralised procedure.

6        On 22 August 2024, the EMA informed the applicant that it had received a request pursuant to Regulation No 1049/2001 for access to documents relating to the scientific advice.

7        In its response of 29 August 2024, the applicant informed the EMA that it had identified information constituting commercially confidential information in the document ‘Ferric carboxymaltose_FAL_4401-1-2020’ produced in the context of a first batch of documents relating to the scientific advice and submitted a copy of that first batch of documents in which it marked the parts which it claimed to be confidential.

8        On 19 September 2024, the EMA notified the applicant of its decision to disclose the first batch of documents relating to the scientific advice, while refusing several of the proposed redactions.

9        On 23 September 2024, the EMA consulted the applicant with regard to a second batch of documents relating to the scientific advice.

10      By email of 30 September 2024, the applicant submitted a copy of the documents containing the proposed redactions concerning the second batch of documents relating to the scientific advice.

11      On 9 October 2024, the applicant informed the EMA that it accepted the EMA’s rejection of some of its proposed redactions, but disagreed with its decision to reject a number of other proposed redactions.

12      On 28 October 2024, the EMA adopted the contested decision, granting access to the documents in the first batch relating to the scientific advice in a redacted form while upholding its position regarding the rejection of certain redactions requested by the applicant.

13      On 29 October 2024, the applicant informed the EMA of its intention to bring an action before the General Court on the basis of Article 263 TFEU and an application for interim measures under Articles 278 and 279 TFEU against the contested decision in so far as the EMA was disclosing commercially confidential information contained in the first batch of documents relating to the scientific advice. It therefore requested the EMA to refrain from disclosing the first batch of documents relating to the scientific advice without having made the redactions requested by its letter of 9 October 2024, until a decision had been given on the application for interim measures.

14      On 5 November 2024, the EMA acknowledged receipt of the applicant’s letter of 29 October 2024 and informed it that it would respond to it in due course. It also confirmed that it would not disclose the documents relating to that request before its response.

15      On 18 December 2024, the EMA informed the applicant of some additional considerations as regards the contested decision. In that letter, the EMA undertook not to disclose the documents at issue if the applicant notified it of its intention to bring an action for annulment before the Court of that decision before 3 January 2025 and expressly stated that it would not be necessary to submit an application for interim measures in order to obtain suspension of the operation of the decision to disclose in part the documents at issue.

16      By application lodged at the Registry of the General Court on 28 December 2024, the applicant brought an action for, inter alia, annulment of the contested decision.

17      By separate document, lodged at the Court Registry on the same date, the applicant brought the present application for interim measures, in which it claims that the President of the General Court should:

–        suspend the operation of the contested decision and of any subsequent decision until the Court has given a decision in the main proceedings;

–        order the EMA not to disclose the documents at issue until the Court has given a decision in the main proceedings;

–        order other interim measures that may be deemed appropriate;

–        order the EMA to pay the costs.

18      In its observations on the application for interim measures which were lodged at the Court Registry on 17 January 2025, the EMA contends that the President of the General Court should dismiss the application for interim measures as inadmissible for lack of interest in bringing proceedings.

 Law

 General considerations

19      It is apparent from reading Articles 278 and 279 TFEU together with Article 256(1) TFEU that the judge hearing an application for interim measures may, if he or she considers that the circumstances so require, order that the operation of a measure challenged before the Court be suspended or prescribe any necessary interim measures, pursuant to Article 156 of the Rules of Procedure of the General Court. Nevertheless, Article 278 TFEU establishes the principle that actions do not have suspensory effect, since acts adopted by the institutions of the European Union are presumed to be lawful. It is therefore only exceptionally that the judge hearing an application for interim measures may order the suspension of operation of an act challenged before the Court or prescribe any interim measures (order of 19 July 2016, Belgium v Commission, T‑131/16 R, EU:T:2016:427, paragraph 12).

20      The first sentence of Article 156(4) of the Rules of Procedure provides that applications for interim measures must state ‘the subject matter of the proceedings, the circumstances giving rise to urgency and the pleas of fact and law establishing a prima facie case for the interim measure applied for’.

21      Thus, the judge hearing an application for interim measures may order suspension of operation of an act and other interim measures, if it is established that such an order is justified, prima facie, in fact and in law, and that it is urgent in so far as, in order to avoid serious and irreparable harm to the applicant’s interests, it must be made and produce its effects before a decision is reached in the main action. Those conditions are cumulative, and consequently an application for interim measures must be dismissed if any one of them is not satisfied. The judge hearing an application for interim measures is also to undertake, when necessary, a weighing of the competing interests (see order of 2 March 2016, Evonik Degussa v Commission, C‑162/15 P-R, EU:C:2016:142, paragraph 21 and the case-law cited).

22      In the context of that overall examination, the judge hearing the application for interim measures has a wide discretion and is free to determine, having regard to the specific circumstances of the case, the manner and order in which those various conditions are to be examined, there being no rule of law imposing a pre-established scheme of analysis within which the need to order interim measures must be assessed (see order of 19 July 2012, Akhras v Council, C‑110/12 P(R), not published, EU:C:2012:507, paragraph 23 and the case-law cited).

23      Having regard to the material in the case file, the President of the General Court considers that he has all the information needed to rule on the present application for interim measures without there being any need to first hear oral argument from the parties.

24      In the circumstances of the present case, and without its being necessary to rule on the admissibility of the present application for interim measures, it is appropriate to examine first whether the condition relating to urgency is satisfied.

 The condition relating to urgency

25      In order to determine whether the interim measures sought are urgent, it should be noted that the purpose of the procedure for interim relief is to guarantee the full effectiveness of the future final decision, in order to prevent a lacuna in the legal protection afforded by the EU judicature. To attain that objective, urgency must in general be assessed in the light of the need for an interlocutory order to avoid serious and irreparable damage to the party requesting the interim measure. That party must demonstrate that it cannot await the outcome of the main proceedings without suffering serious and irreparable damage (see order of 14 January 2016, AGC Glass Europe and Others v Commission, C‑517/15 P-R, EU:C:2016:21, paragraph 27 and the case-law cited).

26      It is in the light of those criteria that it must be examined whether the applicant has succeeded in demonstrating urgency.

27      In the present case, the applicant submits that it will suffer serious and irreparable damage since the disclosure of the information at issue to a third party will irrevocably deprive it of its commercially confidential information.

28      In addition, the applicant claims that disclosure of the information at issue would place it at a competitive disadvantage vis-à-vis recipients of the information, as its competitors could benefit directly, without any further effort, from the confirmation of the authorities’ position in that regard. Also, such disclosure could significantly influence the development process by enabling competitors to save significant development time, resources and cost carrying.

29      According to the applicant, it is therefore apparent that the recipient of the information at issue would gain considerable knowledge and save numerous expenses, thus giving it an advantage quickly to develop a competing medicinal product, and in turn weakening the applicant’s competitive position.

30      In that context, the applicant claims that that situation is itself liable to cause it considerable, serious and irreparable financial damage. In its view, any competitive advantage the applicant might have deservedly achieved for putting years of research and significant resources into the medicinal product would be lost indefinitely.

31      Lastly, the applicant submits that the mere non-binding statement by the EMA in its letter of 18 December 2024 that it will not disclose the documents if an annulment action is filed and that therefore no application for interim measures is necessary does not have any effect on the urgency in the present case. This is because that statement does not contain any legally binding promise.

32      The EMA does not express a view on the condition relating to urgency. It maintains, however, that the application for interim measures is devoid of purpose and, therefore, inadmissible, since it has already undertaken on several occasions not to disclose the documents at issue.

33      As a preliminary point, it should be noted that the disclosure of a document under Regulation No 1049/2001 has an erga omnes effect in that the document may be communicated to other applicants for access and any person has the right to access it. Accordingly, once the information at issue has been disclosed, it cannot be ruled out that the persons who applied for access may make it public by publishing it on the internet. The possibility that the information at issue may be disclosed subsequently would thus contribute to weakening the applicant’s commercial position and increase the risk of serious and irreparable harm (see, to that effect, order of 21 July 2023, Arysta Lifescience v EFSA, T‑222/23 R, not published, EU:T:2023:417, paragraph 35 and the case-law cited).

34      As regards the arguments based on the disclosure of confidential information, it should be borne in mind that it is apparent from the case-law of the Court of Justice that, when, first, the applicant for interim measures alleges that the information whose publication he, she or it wishes provisionally to prevent constitutes business secrets and, second, that allegation satisfies the condition that there is a prima facie case, the judge hearing an application for interim measures is in principle required, when examining the condition of urgency, to presume that the information constitutes business secrets (see, to that effect, order of the Vice-President of the Court of 12 June 2018, Nexans France and Nexans v Commission, C‑65/18 P(R), EU:C:2018:426, paragraph 21).

35      Assuming that the condition that there is a prima facie case is satisfied in the present case, it must therefore be presumed, for the purpose of assessing the condition relating to urgency, that the disclosure of the information at issue will lead to the disclosure of confidential information.

36      Starting from that presumption, the disclosure of the information at issue would necessarily cause significant harm to the applicant (see, to that effect, order of 20 July 2016, PTC Therapeutics International v EMA, T‑718/15 R, not published, EU:T:2016:425, paragraph 105 and the case-law cited).

37      In the present case, the applicant requested the EMA, on 29 October 2024, to refrain from disclosing the first batch of documents relating to the scientific advice without having made the redactions requested by its letter of 9 October 2024, until a decision had been given on the application for interim measures.

38      On 5 November 2024, the EMA acknowledged receipt of the applicant’s letter of 29 October 2024 and informed it that it would respond to it in due course. It also confirmed that it would not disclose the documents relating to that request before its response.

39      Moreover, it should be noted that, in addition to the EMA’s communication of 5 November 2024 by which it confirmed that it would not disclose the documents at issue before its response, the EMA informed the applicant, on 18 December 2024, that it would not disclose the documents at issue if the applicant notified it of its intention to bring an action for annulment before the General Court of its decision before 3 January 2025 and expressly stated that it would not be necessary to submit an application for interim relief in order to obtain suspension of the operation of the decision to disclose in part the documents at issue.

40      In addition, in its observations of 17 January 2025 on the application for interim measures, the EMA again undertook before the Court to suspend the operation of the contested decision pending the decision on the action for annulment of that decision brought by the applicant.

41      Consequently, the risk of disclosure of confidential information on which the applicant relies in order to establish the urgency of its application for interim measures remains hypothetical, since the EMA has stated that it does not wish to disclose it. It is true that this is a unilateral undertaking and not an obligation imposed by a judicial decision. However, the fact remains that the EMA has reiterated its undertaking before the EU judicature. Moreover, if the EMA did not comply with it, it would not only undermine its reputation and credibility as an agency responsible for the authorisation and development of new medicinal products, but would also expose itself to claims for damages.

42      In the light of the foregoing, it must be concluded that the applicant has not succeeded in showing that there is a risk that serious and irreparable damage may occur.

43      Since the applicant has not established that the condition relating to urgency has been satisfied, the application for interim measures must be dismissed, without its being necessary to rule on whether there is a prima facie case or to weigh up the interests involved.

44      Since this order closes the proceedings for interim measures, it is necessary to cancel the order of 30 December 2024, Teva Pharma v EMA (T‑666/24 R, not published), adopted on the basis of Article 157(2) of the Rules of Procedure, by which the EMA was ordered to suspend the operation of the contested decision until the date of the order bringing the present interim proceedings to an end.

45      Pursuant to Article 158(5) of the Rules of Procedure, it is appropriate to reserve the costs.

On those grounds,

THE PRESIDENT OF THE GENERAL COURT

hereby orders:

1.      The application for interim measures is dismissed.

2.      The order of 30 December 2024, Teva Pharma v EMA (T‑666/24 R), is cancelled.

3.      The costs are reserved.

Luxembourg, 27 March 2025.

*      Language of the case: English.