SD v European Medicines Agency (T-623/22)

Contents

Judgment of the General Court (Fourth Chamber, Extended Composition)19 November 2025^note(Access to documents — Regulation (EC) No 1049/2001 — EMA documents concerning the messenger RNA vaccine against COVID-19 Comirnaty — Conditional marketing authorisation — Specific obligations — Responses provided by the authorisation holder to the EMA — Partial refusal to grant access — Communication of partially redacted documents after notification of the contested decision — Action for annulment — Time limit for bringing proceedings — Admissibility — Interest in bringing proceedings — Correcting decision — Action which has become devoid of purpose — No need to adjudicate — Protection of the commercial interests of a third party — Document disseminated on the internet following a cyberattack — Overriding public interest)In Case T‑623/22,SD, represented by A. Steindl, lawyer,vEuropean Medicines Agency (EMA), represented by F. Behre, G. Gavriilidou and H. Kerr, acting as Agents,supported byBioNTech SE, established in Mainz (Germany),BioNTech Manufacturing GmbH, established in Mainz,BioNTech Manufacturing Marburg GmbH, established in Marburg (Germany),represented by P. Bogaert and K. Ewert, lawyers, and B. Kelly, Solicitor,THE GENERAL COURT (Fourth Chamber, Extended Composition),composed, at the time of the deliberations, of R. da Silva Passos, President, J. Schwarcz, N. Półtorak, I. Reine (Rapporteur) and T. Pynnä, Judges,Registrar: S. Jund, Administrator,having regard to the written part of the procedure,having regard to the applicant’s offer of evidence lodged at the Registry of the General Court on 25 October 2023 and the observations of the EMA and the interveners on that offer of evidence lodged on 8 February 2024,having regard to the order of 29 May 2024 by which the General Court, by way of a measure of inquiry, ordered the EMA to produce in full the documents to which it had partially refused access and the production of those documents by the EMA on 14 June 2024,further to the hearing on 6 March 2025,gives the following

Judgment

1By his action under Article 263 TFEU, the applicant, SD, seeks the annulment of the decision contained in letter EMA/254928/2022 of the European Medicines Agency (EMA) of 21 July 2022, by which it partially refused access to certain documents requested pursuant to 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) (‘the contested decision’).

I.Background to the dispute

2On 21 December 2020, the European Commission adopted Implementing Decision C(2020) 9598 final, granting a conditional marketing authorisation for the medicinal product for human use Comirnaty – COVID-19 mRNA vaccine (nucleoside modified) in accordance with Regulation (EC) No 726/2004 of the European Parliament and of the Council. That authorisation was granted to BioNTech Manufacturing GmbH (‘BioNTech’) subject to compliance with certain specific obligations within the meaning of Article 14-a(4) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ 2004 L 136, p. 1) and Article 5 of Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation No 726/2004 (OJ 2006 L 92, p. 6).

3Those specific obligations were defined in Annex II to the conditional authorisation decision referred to in paragraph 2 above. The first of those obligations provided that the holder of the conditional marketing authorisation (‘the MA’) had to provide additional data in order to complete the characterisation of the active substance and the finished product at issue.

4On 28 December 2021, the applicant sent the EMA an application for access to documents, which he specified by emails of 24 January and 2 March 2022. His application concerned, inter alia, part (a) of the first specific obligation (‘SO1(a)’), as defined on page 5 of the EMA public assessment report on the conditional MA’s annual renewal of 14 October 2021 (bearing the reference EMA/596333/2021) (‘the assessment report of 14 October 2021’). That application was registered by the EMA under reference ASK-103611.

5In response to the applicant’s application for access, the EMA stated that it had identified, inter alia, the following three documents: first, ‘Responses to specific obligation’, second, ‘Response to EMA request for supplementary information dated 22 September 2021 – query 1’, and, third, ‘Section 3.2.S.3.1. Elucidation of structure and other characteristics’ (taken together, ‘the documents at issue’).

6On 8 March 2022, the EMA consulted BioNTech concerning the disclosure of the documents at issue, pursuant to Article 4(4) of Regulation No 1049/2001, and of document EMA/729522/2016 of 4 October 2018 entitled ‘European Medicines Agency policy on access to documents’.

7On 8 April 2022, the EMA informed the applicant that partial access to the documents at issue would be granted to him (‘the initial decision to grant access’).

8On the same day, the applicant sent a message to the EMA in which he stated that he wished to challenge the initial decision to grant access, in so far as it granted only partial access to the documents at issue.

9On 29 April 2022, after notifying BioNTech of its intention to that effect, the EMA sent the applicant the documents at issue, the content of which had been partially redacted.

10On 4 May 2022, following an email from the EMA of the same day asking the applicant whether he still wished to challenge the initial decision to grant access, the applicant confirmed that he intended to call that decision into question and that he wished to obtain full disclosure of the documents at issue.

11By letter of 21 July 2022 containing the contested decision, which was notified to the applicant the following day through the Eudralink platform, the EMA replied to the applicant that, after re-examination of the initial decision to grant access, the documents at issue could be disclosed to a greater extent. However, the EMA stated that a partial redaction of the content of those documents was still necessary in order to protect BioNTech’s commercial interests.

12On 8 August 2022, after notifying BioNTech of its intention to that effect, the EMA transmitted the documents at issue, in part redacted, to the applicant through the Eudralink platform. The applicant became aware of that transmission the following day.

II.Facts subsequent to the bringing of the action

13On 25 October 2023, in its observations on the statement in intervention of the interveners, BioNTech SE, BioNTech and BioNTech Manufacturing Marburg GmbH, the applicant informed the Court that, by chance while searching the internet, he had found information likely to be similar to the data redacted in the documents at issue. He referred, first, to the EMA report bearing the reference EMA/CHMP/448917/2021 and, second, to a 152-page document from Pfizer and BioNTech, marked as confidential and with content largely similar to that which had been redacted in the documents at issue. By a separate document lodged on 28 November 2023, the applicant made a new submission including those two documents as offers of evidence, pursuant to Article 85(3) of the Rules of Procedure of the General Court.

14In its observations on the new evidence submitted by the applicant, the EMA confirmed that the document bearing the reference EMA/CHMP/448917/2021 corresponded to an assessment report that it had disclosed on 14 July 2022, following an application for access to documents lodged by a third party on the basis of Regulation No 1049/2001 (‘the EMA report disclosed on 14 July 2022’).

15By letter of 7 February 2024 bearing reference EMA/55289/2024, notified to the applicant on the same day by email, the EMA informed the applicant of its decision to correct the contested decision (‘the correcting decision’). In that letter, the EMA acknowledged that, due to human error, it had redacted in the documents at issue material which it had, however, already disclosed on 14 July 2022, in the context of another application for access, referred to in paragraph 14 above, and therefore agreed to disclose that information. By contrast, the EMA maintained the redactions relating to the other information, for the reasons given in the contested decision.

III.Forms of order sought

16The applicant claims that the Court should:– annul the contested decision;– order the EMA to pay all the costs or, if the action is dismissed, to bear its own costs, on equitable grounds, in accordance with Article 135(1) of the Rules of Procedure.

17The EMA, supported by the interveners, claims that the Court should:– dismiss the action;– order the applicant to pay the costs.

IV.Law

A.Admissibility

1.Compliance with the time limit for bringing proceedings

18As is apparent from paragraphs 11 and 12 above, the documents at issue were not made known to the applicant at the same time as the contested decision. In that regard, the EMA considers, as does the applicant, that the period for bringing an action laid down in the sixth paragraph of Article 263 TFEU began to run from the notification of the documents at issue.

19Under the sixth paragraph of Article 263 and the third subparagraph of Article 297(2) TFEU, the date to be taken into account for determining the starting point of the period prescribed for bringing annulment proceedings is the date of notification of the act in question where it specifies the person to whom it is addressed. A decision is properly notified if it is communicated to the person to whom it is addressed and the latter is put in a position to become acquainted with it. With regard to the latter condition, the Court considers that it is fulfilled when the person to whom a decision is addressed was in a position to become acquainted with the content of that decision and the grounds on which it was based (judgment of 21 March 2019, Eco-Bat Technologies and Others v Commission, C‑312/18 P, not published, EU:C:2019:235, paragraphs 25 and 26).

20It should also be borne in mind that, in assessing the existence of a notification within the meaning of the sixth paragraph of Article 263 and the third subparagraph of Article 297(2) TFEU, account must be taken of the principle of legal certainty and the right to an effective remedy enshrined in Article 47 of the Charter of Fundamental Rights of the European Union (see, to that effect, judgment of 3 March 2021, Barata v Parliament, T‑723/18, EU:T:2021:113, paragraph 44).

21In the present case, it should be noted that, pursuant to Article 4(4) of Regulation No 1049/2001, the EMA policy on access to documents, referred to in paragraph 6 above, provides, in Section 5.5 thereof, for consultation of the third party concerned where the EMA receives an application for access to documents which contain information from that third party, as in the present case. However, the opinion of the third party concerned is not binding.

22In addition, in response to the Court’s questions, the EMA explained the specific procedure which it was implementing, pursuant to Section 5.7 of its policy on access to documents, when it intended to adopt a decision on an application for access. The EMA thus stated that, in such a situation, it would inform the third party concerned of its decision to disclose certain information and of the possible legal remedies against that decision. The third party concerned then had a time limit of 10 working days in which to notify its intention, where appropriate, to challenge the proposed disclosure before the Court. In the event of such a challenge within the prescribed time limit, the EMA refrained from communicating the documents until the outcome of the proceedings.

23According to the EMA, an action for annulment could be brought before the General Court by the third party concerned on the basis of Article 263 TFEU, as, for example, in the case which gave rise to the judgment of 28 June 2019, Intercept Pharma and Intercept Pharmaceuticals v EMA (T‑377/18, not published, EU:T:2019:456).

24The EMA added that that particular procedure therefore implied that, when it notified the person making an application of its decision on the application for access, that notification was not accompanied either by immediate or by automatic communication of the requested documents, as that could depend on the outcome of a possible action by the third party concerned before the Court. In addition, at the hearing, the EMA contended that its decision on the application for access could be regarded as having been notified to the applicant in its entirety only once the documents at issue had actually been communicated to him, as was evidenced, moreover, by the unique file number it had used to notify the applicant of the contested decision on 22 July 2022 and of the documents at issue the following 8 August.

25In that particular context, it must be held that, in the present case, the time limit for bringing the action for annulment of the contested decision did in fact begin to run at the earliest on the date on which the documents at issue were sent to the applicant through the Eudralink platform on 8 August 2022. Given that the present action for annulment was lodged at the Registry of the General Court on 7 October 2022, it was indeed brought within the time limit laid down in the sixth paragraph of Article 263 TFEU.

2.The subject matter of the action after the correcting decision was adopted

26As is apparent from paragraph 15 above, the EMA adopted the correcting decision after the date on which the present action was brought. The EMA acknowledged therein that the information contained in the EMA report disclosed on 14 July 2022, found by the applicant by chance during his internet searches, had already entered the public domain at the time the contested decision was adopted and that it should therefore have been communicated to him. The EMA therefore corrected the contested decision by agreeing to send the applicant the data already contained in its report that was released on 14 July 2022 (‘the data disclosed after correction’), while maintaining the other redactions in the documents at issue, for the reasons set out in the contested decision.

27As a preliminary point, it should be observed that the correcting decision partially alters the contested decision itself and therefore the subject matter of the action. Contrary to what the applicant claims, it does not constitute a new offer of evidence in support of the EMA’s arguments, within the meaning of Article 85 of the Rules of Procedure.

28In any event, the correcting decision was adopted following the production, by the applicant, of the EMA report that was disclosed on 14 July 2022 in order to correct the error in the contested decision which came to light after the defence was lodged. The correcting decision cannot therefore be rejected as inadmissible under Article 85 of the Rules of Procedure on the ground that it was belated.

29As regards the impact of the correcting decision on the subject matter of the action, it should be recalled that, according to the Court’s settled case-law, the subject matter of the dispute, like the interest in bringing proceedings, must continue until the final decision, failing which there will be no need to adjudicate, which presupposes that the action must be liable, if successful, to procure an advantage for the party bringing it (see judgments of 30 April 2020, Izba Gospodarcza Producentów i Operatorów Urządzeń Rozrywkowych v Commission, C‑560/18 P, EU:C:2020:330, paragraph 38 and the case-law cited, and of 21 January 2021, Leino-Sandberg v Parliament, C‑761/18 P, EU:C:2021:52, paragraph 32 and the case-law cited).

30In the present case, as is apparent from paragraph 26 above, the correcting decision partially amended the contested decision as regards the data disclosed after correction. Given that the applicant did not alter the subject matter of his action following the adoption of that decision, either in his written pleadings or by a modification of his application, the action must be regarded as having become devoid of purpose in so far as it concerns access to the data disclosed after correction.

31Indeed, an action for annulment may, exceptionally, not become devoid of purpose despite the withdrawal of the act whose annulment is sought in circumstances where the applicant nevertheless retains a sufficient interest in obtaining a judgment formally annulling it (see order of 12 January 2011, Terezakis v Commission, T‑411/09, EU:T:2011:4, paragraph 17 and the case-law cited). An applicant may in particular, in certain cases, retain an interest in seeking annulment of the contested act in order to induce the author of that act to make suitable amendments in the future, and thereby avoiding the risk that the unlawfulness alleged in respect of the act in question will be repeated. The continuation of that interest presupposes that that unlawfulness is liable to recur in the future, irrespective of the particular circumstances of the case in question (see judgment of 4 September 2018, ClientEarth v Commission, C‑57/16 P, EU:C:2018:660, paragraph 48 and the case-law cited). However, it is for an applicant to prove its interest in bringing proceedings, which is an essential and fundamental prerequisite for any legal proceedings (judgment of 7 November 2018, BPC Lux 2 and Others v Commission, C‑544/17 P, EU:C:2018:880, paragraph 33).

32The applicant has not put forward any detailed argument which would enable the Court to conclude that, in accordance with the case-law cited in paragraph 31 above, he retains his interest in bringing proceedings.

33Furthermore, the arguments raised by the applicant at the hearing, according to which the adoption of the correcting decision involved a tactic by the EMA to avoid judicial scrutiny and resulted in circumvention of the principles of legal certainty and the protection of legitimate expectations, are also not such as to preclude the partial disappearance of the subject matter of the action. Moreover, they are not substantiated, as the EMA acknowledged human error during the adoption of the contested decision.

34In the light of the foregoing, there is no longer any need to adjudicate on the application for annulment of the contested decision in so far as that decision refuses access to the data disclosed after correction.

35It should be added that, in the correcting decision, the EMA maintained the redaction of the other undisclosed information, referring explicitly to the reasons set out in the contested decision, without amending the contested decision in that regard. The subject matter of the action therefore remains the same in so far as it concerns the refusal of access to that other information, the redaction of which was maintained.

36Therefore, the Court will examine below the application for annulment of the contested decision only in so far as it refuses the applicant access to the information which was still redacted following the adoption of the correcting decision.

B.Substance

37In support of his action, the applicant relies on two pleas in law, alleging, first, infringement of the first indent of Article 4(2) of Regulation No 1049/2001, in so far as the EMA considered that the partial redaction of the documents at issue was justified by the protection of the commercial interests of a third party and, second, infringement of the last sentence of Article 4(2) of that regulation, in so far as the EMA found that there was no overriding public interest in disclosure.

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

38In his first plea in law, the applicant claims that the EMA could not consider that the redacted data in the documents at issue, relating to qualitative aspects such as the characterisation of the active substance and the finished product, were covered by the exception laid down in the first indent of Article 4(2) of Regulation No 1049/2001. In that regard, he raises seven complaints, which correspond to the seven parts of that plea.

39In essence, first, he complained that the EMA misapplied the guidance document of the Heads of Medicines Agencies and the EMA on the identification of commercially confidential information and personal data in the context of MA applications – release of information after the granting of an MA (‘the disclosure guidance document’). Second, he complained that the EMA breached the principle of the widest possible public access to documents and failed to take account of certain applicable provisions. Third, the EMA infringed the disclosure guidance document as well as its mandate and competences. Fourth, the EMA misapplied the concept of ‘control strategy’ and, in essence, provided irrelevant and incomplete information. Fifth, the EMA failed to take into account World Health Organisation (WHO) standards. Sixth, the redacted data were in the public domain, their redaction was disproportionate and the EMA did not give sufficient reasons for the harm allegedly caused by disclosure to BioNTech’s commercial interests. Seventh, the EMA wrongly made assumptions about the context of the application for access.

40It is appropriate to start by examining the fourth part of the first plea in law. Next, the second and fifth parts of that plea will be analysed together, followed by the other parts thereof.

(a)The fourth part of the first plea in law, relating, in essence, to a misapplication of the concept of control strategy and the irrelevant and incomplete nature of the data communicated

41The applicant claims that his application for access to documents did not concern the documents relating to control strategies, but to SO1(a). In that regard, in essence, the reasoning in the contested decision, which refers to the concept of ‘control strategy’, is vitiated by the three errors below.

42First, by relying on the confidential nature of the control strategy data in order to justify the refusal to grant access to the redacted data, the applicant claims that the EMA was mistaken as to the content of such strategy, as defined in guideline Q10 on pharmaceutical quality system of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, and improperly equated the SO1(a) data to such strategy.

43Second, the applicant claims that by equating responses to specific obligations such as SO1(a) with information on control strategies, the EMA ignored the difference in legal nature between those two concepts. Specific obligations are subject to a disclosure requirement and enhanced transparency in accordance with the EMA guideline of 25 February 2016 on the scientific application and practical arrangements necessary to implement Commission Regulation No 507/2006 on the conditional MA for medicinal products for human use falling within the scope of Regulation No 726/2004 (‘the guideline on the implementation of Regulation No 507/2006’).

44Third, the applicant claims that the data submitted by the EMA do not contain a monthly report, even though they were part of SO1(a). In addition, in view of the extent of the redactions in question, the documents transmitted do not make it possible to ascertain the content of the responses to SO1(a).

45The applicant also claims that the right to full access to the documents at issue is not subject to an obligation to state reasons and does not depend on the scientific competence of the person making an application, which the EMA disregarded in the contested decision.

46The EMA, supported by the interveners, disputes the applicant’s line of argument.

(1)The subject matter of the application for access and failure to communicate the monthly reports

47As regards the subject matter of the application for access, in the first place, it is apparent from the email sent by the applicant to the EMA on 2 March 2022 that, by his initial application for access, he wished to obtain BioNTech’s responses to SO1(a). In that regard, the applicant had referred to page 5 of the assessment report of 14 October 2021, inserting a hyperlink to that document. That page 5 referred exclusively to a report sent on 2 August 2021, without also mentioning monthly reports on SO1(a).

48At the hearing, the EMA stated that it had not communicated to the applicant the monthly reports relating to SO1(a), although those documents existed, on the ground that they were clearly not part of the application for access.

49In that regard, it should be noted that, although page 5 of the assessment report of 14 October 2021 did not in fact mention monthly reports, by contrast, page 11 of that document, to which the applicant also had access, clearly indicated that such reports had been submitted to the EMA.

50In any event, the applicant should have been aware of the existence of the monthly reports relating to SO1(a) when the documents at issue were first communicated by the EMA on 29 April 2022. Those monthly reports were explicitly referred to on the second page of the first of those documents.

51In his email of 4 May 2022, supplementing the email of 8 April 2022 (together, ‘the confirmatory application’), the applicant did not, however, dispute the EMA’s identification of the documents at issue in response to his initial application for access.

52Moreover, as stated in recital 13 of Regulation No 1049/2001, a two-stage administrative procedure applies, with the additional possibility of court proceedings or complaints to the European Ombudsman, in order to ensure that the right of public access to documents of the EU institutions is fully respected. Similarly, according to the case-law, Articles 7 and 8 of Regulation No 1049/2001, by providing for a two-stage procedure, aim to achieve, first, the swift and straightforward processing of applications for access to documents of the institutions concerned and, second, as a priority, a friendly settlement of disputes which may arise (judgment of 26 January 2010, Internationaler Hilfsfonds v Commission, C‑362/08 P, EU:C:2010:40, paragraphs 53 and 54).

53In that regard, in order for the two-stage procedure referred to in paragraph 52 above to achieve its objective, the EU institution, body, office or agency to which a confirmatory application has been made must be able to rely on the terms of that application in order to identify the information or documents which the person making an application wishes to be disclosed following the adoption of an initial decision to grant access. It is therefore for any person making an application to satisfy himself or herself that the documents the disclosure of which he or she has requested were communicated to him or her following his or her initial application and to define the scope of his or her confirmatory application accordingly.

54In the present case, having regard, first, to the explicit and clear reference to the monthly reports in the documents communicated to the applicant on 29 April 2022 and, second, to the wording of the confirmatory application, which is intended solely to challenge the redactions in the documents at issue, the applicant cannot criticise the EMA for having limited its examination to those redactions in order to adopt the contested decision, and for not having disclosed to him the monthly reports at issue which were not mentioned therein.

55In the second place, it is apparent from the documents at issue that the information contained therein was specifically intended to respond to SO1(a). The first two documents, entitled, respectively, ‘Responses to specific obligation’ and ‘Response to EMA request for additional information dated 22 September 2021 – query 1’ explicitly state that they provide responses to SO1(a). As regards the third document, entitled ‘Section 3.2.S.3.1. Elucidation of structure and other characteristics’, that was submitted to the EMA on 4 November 2021 in order to substantiate BioNTech’s response to SO1(a), it provides additional information on the quality of the Comirnaty vaccine, in particular on the characterisation and structure of the drug substance, and tends to demonstrate that it has the required structure.

56Consequently, the documents at issue contained information relevant to the applicant’s application for access, notwithstanding the extent of the maintained redactions and the reasons put forward by the EMA to justify them.

57Moreover, following the adoption of the correcting decision, the amount of information redacted in the documents at issue was considerably reduced, now being limited to certain tables and a few specific figures. The applicant cannot therefore claim that the documents at issue did not make it possible for him to know the content of the responses to SO1(a).

58It follows from the foregoing that the applicant’s arguments alleging misinterpretation of the subject matter of the application for access and failure to communicate the monthly reports relating to SO1(a) must be rejected as unfounded.

59In addition, the applicant’s argument that the right to full access to the documents at issue is not subject to an obligation to state reasons and does not depend on the scientific competence of the person making an application must be rejected. It is not apparent from the contested decision that the EMA refused full access to the documents at issue on the ground that the applicant did not state reasons for his application. Nor is the scientific competence of the person making an application relied upon in that decision. Consequently, that argument must, in any event, be rejected.

(2)Incorrect equating of SO1(a) with the concept of control strategy

60It is apparent from guideline Q10 on pharmaceutical quality system of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, cited by the applicant, that the control strategy is a set of controls designed to ensure that a product of required quality is manufactured in a uniform manner. The controls carried out must be based on the product, formulation and understanding of the process. In that context, it is necessary in particular to identify the sources of variability in order to ensure that they do not impact the quality of the medicinal product. That definition also appears in Part II, Section 2.5. of guideline Q8 (R2) on pharmaceutical development – Step 5 of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use of 22 June 2017, cited by the EMA in its defence pleadings.

61In the contested decision, the EMA explained, in essence, that an effective control strategy, which is necessary for the grant of an MA, is based on an understanding of the relevant quality characteristics of the medicinal product and their potential impact on its safety and efficacy. The control strategy is therefore closely linked to the results of tests, which contribute to its development and implementation. Thus, the information gathered in response to SO1(a), which concerns the characterisation of the active substance and the Comirnaty vaccine, ought to enable the EMA to better understand how the steps of the manufacturing process of the Comirnaty vaccine were controlled and to ensure the quality of that vaccine, as the EMA confirmed at the hearing.

62The interveners also confirmed that an understanding of the relevant quality attributes and their potential impact on the safety and efficacy of the medicinal product was indispensable in order to develop an effective control strategy.

63Thus, the EMA explained that the redacted data in the documents at issue, which related to the characterisation of the active substance and the finished product and to the methods and test results in that regard, and which had been requested in the context of SO1(a), constituted elements intrinsically linked to the control strategy, without, however, equating the entirety of those data to the control strategy itself.

64Therefore, even though the EMA referred to the confidentiality of the control strategies in the grounds for the contested decision, it is not apparent from that decision that it equated the responses to SO1(a) with the control strategy per se. Moreover, given that such equivalence of concepts has not been demonstrated in the present case, the applicant cannot claim that, by equating them, the EMA disregarded the difference in legal nature between them.

65In the light of the foregoing, the fourth part of the first plea in law must be rejected.

(b)The second and fifth parts of the first plea in law, relating to the breach of the principle of the widest possible public access to documents and to the failure to take account of certain applicable provisions, including WHO standards

66The applicant submits that the EMA erred in law by not undertaking a strict interpretation of the exception relating to the protection of commercial interests, without taking into account other applicable provisions which confirm the obligation to ensure increased transparency as regards the specific obligations. According to the case-law, it is appropriate to ensure that each of those pieces of legislation is applied in a manner compatible with the other, thereby enabling a coherent application.

67In that regard, first, the applicant refers to recital 10 of Regulation No 507/2006, read in conjunction with Article 8 of that regulation. He also cites the guideline on the implementation of Regulation No 507/2006. In order to fulfil the role assigned to it under that piece of legislation, the applicant claims that the EMA should have disclosed the legal criteria for the authorisation of mRNA substances, without disproportionately protecting the only large producer existing on the market.

68Second, the applicant refers to recitals 14, 38 and 49 of Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the EMA in crisis preparedness and management for medicinal products and medical devices (OJ 2022 L 20, p. 1). In that regard, the applicant claims that the EMA ignored the fact that the specific obligation at issue concerned the main official medical countermeasure put in place by the European Union against COVID-19.

69Third, the applicant relies on Annex 3 to the 74th report of the WHO Expert Committee on Biological Standardisation, entitled ‘Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations’ (‘the WHO report on messenger RNA vaccines’), according to which data relating to basic quality requirements, intended to ensure the safety of the medicinal product, constitute information that must be disclosed.

70In any event, according to the applicant, the contested decision did not contain any relevant explanation as to why disclosure of the information relating to SO1(a) undermined BioNTech’s trade secrets, despite the strict reasoning obligations related to the application of exceptions provided for in Article 4 of Regulation No 1049/2001. In his responses to a question put by the Court, the applicant added that, in the correcting decision, the EMA could not justify the redactions maintained by a mere reference to the obsolete reasoning set out in the contested decision.

71The EMA, supported by the interveners, disputes the applicant’s arguments.

(1)Preliminary observations

72It should be recalled that Regulation No 1049/2001 is designed, as stated in recital 4 and Article 1 thereof, to confer on the public as wide a right of access as possible to documents of the institutions (judgments of 28 June 2012, Commission v Éditions Odile Jacob, C‑404/10 P, EU:C:2012:393, paragraph 111, and of 28 June 2012, Commission v Agrofert Holding, C‑477/10 P, EU:C:2012:394, paragraph 53).

73The principle of the widest possible public access to documents is nonetheless subject to certain limits based on reasons of public or private interest. Regulation No 1049/2001, in particular in recital 11 and Article 4 thereof, provides for a system of exceptions requiring institutions and bodies not to disclose documents in the event that disclosure would undermine one of these interests (see judgment of 5 February 2018, Pari Pharma v EMA, T‑235/15, EU:T:2018:65, paragraph 66 and the case-law cited).

74In that regard, in order to justify refusal of access to a document, it is not sufficient, in principle, for that document to fall within an activity or an interest mentioned in Article 4 of Regulation No 1049/2001. The institution concerned must also show how access to that document could specifically and actually undermine the interest protected by an exception laid down in that article and that the risk of that interest being undermined is reasonably foreseeable and not purely hypothetical (see judgment of 5 February 2018, Pari Pharma v EMA, T‑235/15, EU:T:2018:65, paragraph 69 and the case-law cited).

75That being so, it is not necessary to establish the existence of a definite risk that the protection of the commercial interests of the undertakings concerned will be undermined. It is sufficient that the institution concerned has provided plausible explanations regarding the question of how access to the redacted information could specifically and actually undermine the protection of the commercial interests of the undertakings concerned and whether the risk of that undermining might be considered as reasonably foreseeable and not purely hypothetical (see, to that effect, judgment of 25 November 2020, Bronckers v Commission, T‑166/19, EU:T:2020:557, paragraph 58). Such a risk is established, in particular, where the requested documents contain commercially sensitive information relating, inter alia, to the business strategies of the undertakings concerned or to their commercial relations or where those documents contain information particular to that undertaking which reveal its expertise (judgment of 5 February 2018, Pari Pharma v EMA, T‑235/15, EU:T:2018:65, paragraph 71).

76It should also be observed that, under Article 2(1) of Regulation No 1049/2001, the beneficiaries of the right of access to documents of the institutions are ‘any citizen of the Union, and any natural or legal person residing or having its registered office in a Member State’. That provision makes it clear that the purpose of the regulation is to guarantee access for everyone to public documents and not merely access for the requesting party to documents concerning him or her (see judgment of 28 September 2022, Agrofert v Parliament, T‑174/21, EU:T:2022:586, paragraph 45 and the case-law cited). In other words, when an institution decides to disclose certain data, those data become accessible not only to the person making an application for access, but also to the public.

77Lastly, where Regulation No 1049/2001 and other regulations cited by the applicant do not contain any provision expressly giving one regulation primacy over the other, it cannot be excluded, as a matter of principle, that the exceptions under Article 4(2) of Regulation No 1049/2001 may be interpreted in the light of certain specific rules of EU law. In such a case, it is appropriate to ensure that each of those regulations is applied in a manner which is compatible with the other and which enables a coherent application of them (see, to that effect, judgments of 28 June 2012, Commission v Éditions Odile Jacob, C‑404/10 P, EU:C:2012:393, paragraph 110, and of 26 March 2020, Bonnafous v Commission, T‑646/18, EU:T:2020:120, paragraph 72 and the case-law cited).

78The applicant’s arguments must be assessed in the light of the principles recalled above.

(2)Errors of law alleged by the applicant

79In the first place, it should be recalled that the correcting decision did not replace the contested decision, but only corrected the latter decision in so far as certain redacted information should already have been disclosed on the date the contested decision was adopted. It is therefore the date the contested decision was adopted which must be taken as the basis for assessing the legality of the redactions maintained. Similarly, the grounds relied on in that decision, to which the correcting decision refers, remain relevant in order to assess the legality of those redactions.

80It follows that, contrary to what the applicant claims, the contested decision, as corrected, is not vitiated by a failure to state reasons.

81In the second place, having consulted the full version of the documents at issue, the Court finds that the information which remains redacted in those documents is numerical results of tests associated with the characterisation of the active substance and the finished product Comirnaty as well as information on the parameters used to carry out those tests. As stated, in essence, by the conclusions drawn from those various results, which have been verified by the EMA and which are not redacted, the data obtained from the tests carried out provide information to the EMA on the characterisation of the mRNA substance of the Comirnaty vaccine and seek to demonstrate that the manufacturing process of that vaccine meets the quality requirements laid down by EU legislation.

82Those data are therefore information of a highly technical nature, which was obtained through BioNTech’s know-how and which is contained in the MA application dossier for the Comirnaty vaccine.

83In the contested decision, the EMA explained that disclosure of the redacted information would enable competing pharmaceutical companies using a similar technology and operating in the same therapeutic field or in a different field, to obtain a concrete advantage by saving the scientific efforts, and the human and economic resources necessary for development of their own medicinal product. That concrete advantage for the competitor would consist of using the knowledge of studies conducted by BioNTech on the characterisation of the Comirnaty vaccine and the development of processes, which would ultimately make it possible, without prior experience in the sector or with very limited experience, to determine the optimal test methods and critical quality attributes very easily and to develop a control strategy for a non-standard type of medicinal product.

84The contested decision added that the messenger RNA-based vaccines corresponded to new technology, with the result that there was little industrial experience in that field and little knowledge of the attributes that were critical for the manufacturing process and the test methods and acceptable ranges that led to a safe and effective medicinal product. That information constitutes important and valuable know-how for BioNTech, as the holder of the conditional MA. That know-how, if disclosed, would give a significant advantage to BioNTech’s potential competitors, who could develop their own products more quickly.

85The Court has already ruled that holders of data enjoy, pursuant to the exceptions provided for in Article 4 of Regulation No 1049/2001, protection of commercially confidential information contained in an MA application dossier, including information about the manufacturing of the product and other technical and industrial specifications of the quality processes adopted to manufacture the substance at issue (see, to that effect, judgments of 5 February 2018, PTC Therapeutics International v EMA, T‑718/15, EU:T:2018:66, paragraph 65, and of 25 September 2018, Amicus Therapeutics UK and Amicus Therapeutics v EMA, T‑33/17, not published, EU:T:2018:595, paragraph 56).

86In addition, as is apparent from paragraphs 83 and 84 above, the EMA explained that the redacted data had a real economic value and that their disclosure or use could have economic value for other undertakings, particularly in view of their novel aspect. Added to this is the competitive landscape of COVID-19 vaccine development.

87In the light of the foregoing considerations, the matters set out in the contested decision justify the view that the redacted data at issue constitute commercially sensitive information and are sufficient to support the conclusion that there is a reasonably foreseeable and not purely hypothetical risk that the disclosure of that information would undermine the protection of BioNTech’s commercial interests (see, to that effect, judgment of 7 September 2022, Saure v Commission, T‑651/21, not published, EU:T:2022:526, paragraph 112 and the case-law cited). That is all the more so since, as stated in paragraph 76 above, the EMA’s decision to disclose the data at issue would have the effect of making those data accessible, not only to the applicant, but also to the public, including BioNTech’s competitors.

88That conclusion cannot be called into question by the other documents cited by the applicant, which the EMA allegedly failed to take into account.

89First, it is apparent from recital 10 of Regulation No 507/2006 that ‘clear information should be provided to patients and healthcare professionals on the conditional nature of the [conditional MAs]’ and that ‘such information be clearly stated in the summary of product characteristics of the medicinal product concerned as well as on the package leaflet’. Article 8 of that regulation, for its part, provides that ‘where a medicinal product has been granted [conditional authorisation] in accordance with [that regulation], the information included in the summary of product characteristics and package leaflet shall contain a clear mention of that fact’ and that ‘the summary of product characteristics shall also contain the date on which the conditional [MA] is due for renewal’.

90Recital 10 of Regulation No 507/2006 thus refers to the conditional nature of the authorisation, while Article 8 of that regulation requires that reference be made to the fact that the medicinal product has been granted conditional authorisation. Similarly, as the EMA rightly asserts, it is clear from the wording of those provisions that the information to be communicated to the public concerns the conditional nature of the MA and the date on which it must be renewed, and not detailed sensitive information such as methods and test results relating to the characterisation of a vaccine.

91Furthermore, although Article 8 of Regulation No 507/2006 requires the information to which it refers to be published proactively, it does not relate to the regulatory scheme on access to the documents submitted in the context of an MA and cannot therefore under any circumstances be interpreted as providing for a special regime in that regard (see, to that effect, judgment of 5 February 2018, PTC Therapeutics International v EMA, T‑718/15, EU:T:2018:66, paragraph 51).

92Second, the guideline on the implementation of Regulation No 507/2006, which must be interpreted in accordance with that regulation and in a manner consistent with Regulation No 1049/2001, also does not provide for the disclosure of detailed information relating to the characterisation of a medicinal product. The final subparagraph of Section 4.4. of that guideline states only that the specific obligations and the timeframe for their completion will be clearly specified in the conditional MA and published by the EMA as part of the European public assessment report. Similarly, Section 4.5. of that guideline provides for an obligation of enhanced transparency regarding the conditional nature of those authorisations, which must be clearly stated in the summary of product characteristics and the accompanying package leaflet. Those obligations to clearly state the conditional nature of the authorisation and to disclose the specific obligations imposed and the timeframe for their completion are thus intended to inform the public of their existence, but do not require disclosure of all the detailed technical data provided by the applicant for an MA to the EMA. In that regard, that guideline merely applies the principles set out in Article 8 of Regulation No 507/2006, read in conjunction with recital 10 of that regulation (see paragraphs 89 and 90 above).

93Third, as regards Regulation 2022/123, the applicant does not in any way explain how the decision of the EU legislature to strengthen the EMA’s role in crisis preparedness and management would result in the imposition of an obligation to disclose detailed information concerning the characterisation of an active substance and finished product, which would run counter to the protection of commercial interests provided for in the first indent of Article 4(2) of Regulation No 1049/2001.

94In that regard, recital 14 of Regulation 2022/123, cited by the applicant, states only that it is appropriate to approximate and strengthen the rules on monitoring of shortages of medicinal products and medical devices and to facilitate the research and development of medicinal products which have the potential to treat, prevent or diagnose diseases that cause public health emergencies, with a view to strategically complementing the efforts of the Commission to that effect. That recital does not therefore concern any possible disclosure obligations on the part of the EMA.

95Recital 38 of Regulation 2022/123 does, admittedly, provide that it is imperative to have in place robust transparency measures and standards, which should include the timely publication of all relevant information on approved medicinal products and medical devices and of clinical data, including clinical trial protocols. Similarly, recital 49 thereof emphasises the need to provide for the use of adequate communication tools in order to proactively engage with the general public, so as to ensure a high degree of transparency.

96However, recitals 38 and 49 of Regulation 2022/123 in no way imply that the EMA is required to disseminate all the detailed information relating to the characterisation of a vaccine. On the contrary, it is apparent from the second subparagraph of Article 10(4) and the second subparagraph of Article 17(2) of Regulation 2022/123 that the EMA is still required to examine to what extent the information submitted by MA holders constitutes commercially confidential information that cannot be disclosed. That obligation of confidentiality is emphasised even more explicitly in Article 34(1) of that regulation, which lays down, in essence, the obligation of all parties involved in the application of that regulation to respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the commercially confidential information and trade secrets of natural or legal persons.

97Fourth, the WHO report on messenger RNA vaccines is a non-binding document which, moreover, does not aim to regulate the issue of access to vaccine data. It is intended only to provide guidance on certain key aspects relating to the manufacture and quality control of messenger RNA vaccines. In particular, page 119 of that document, to which the applicant refers in his written pleadings, does not contain any information concerning the alleged public nature of characterisation data.

98Moreover, first, the introduction of Annex 3 to the WHO report on messenger RNA vaccines specifically emphasises the unavailability, on the date of its drafting, of detailed data on production methods and the non-disclosure of certain data on messenger RNA vaccines. Second, it is stated therein that characterisation reveals important data on the structure, performance and safety of the product concerned and thus makes it possible to guide the development and improvement of tests. It is therefore data obtained from the research and know-how of the vaccine manufacturer.

99Consequently, by adopting the contested decision, the EMA provided plausible explanations demonstrating that access to the redacted data in the documents at issue could specifically and actually undermine the commercial interests of the holder of the conditional MA for the Comirnaty vaccine, and that the risk of those interests being undermined was reasonably foreseeable and not purely hypothetical. In so doing, the EMA did not breach the principle of the widest possible public access to documents nor did it wrongly fail to take into account the provisions examined in paragraphs 89 to 98 above.

100The second and fifth parts of the first plea in law must therefore be rejected as unfounded.

(c)The first part of the first plea in law, relating to misapplication of the disclosure guidance document

101The applicant submits that, in view of the conditional nature of the MA granted to the Comirnaty vaccine at the time the contested decision was adopted, the EMA could not rely on the disclosure guidance document to apply a general presumption of confidentiality to the information redacted in the documents at issue in the light of the need to protect BioNTech’s commercial interests. The disclosure guidance document applies only to ordinary MAs, and not to conditional MAs. That is apparent from the explanations therein, which exclude any application of that document to orphan medicinal products. Indeed, orphan medicinal products and conditional MAs fall within the scope of Regulation No 507/2006, which demonstrates that that document applies only to ordinary MAs.

102The applicant adds that the disclosure guidance document contains a table entitled ‘Structure of the Marketing Authorisation Dossier – Module 1’. It is apparent from the part of that table dealing with Sub-module 1.5.5. that information relating to the conditional placing on the market of a medicinal product can be released (CBR).

103The EMA, supported by the interveners, disputes the applicant’s arguments.

104In the present case, in the first place, the Court of Justice has recognised the possibility for the institutions and agencies concerned to base their decisions on general presumptions which apply to certain categories of documents, as considerations of a generally similar kind are likely to apply to requests for disclosure relating to documents of the same nature (judgment of 1 July 2008, Sweden and Turco v Council, C‑39/05 P and C‑52/05 P, EU:C:2008:374, paragraph 50).

105That said, it is apparent from the contested decision that the EMA examined in detail the content of the documents at issue and agreed to disclose certain general information relating to the test methods in those documents. It is also apparent from those documents that the information which remains redacted after the correcting decision was adopted is sparse and precise, a large part of the technical information having ultimately been disclosed.

106Thus, the applicant’s argument that the EMA applied a general presumption of confidentiality in the present case has no factual basis.

107In the second place, while it is true that, in the contested decision, the EMA referred to the principles set out in the disclosure guidance document, that reference was solely intended to confirm that the reasons relied on to justify the redactions, related to the first indent of Article 4(2) of Regulation No 1049/2001, were also in line with that document. Thus, even if the EMA had wrongly based its decision on that document, an error of that kind would not be such as to lead to the annulment of the contested decision, which is based primarily on the first indent of Article 4(2) of Regulation No 1049/2001. The argument is therefore ineffective.

108In any event, it is apparent from the second introductory paragraph of the disclosure guidance document that that document applies to applications for access concerning medicinal products authorised under national procedures, mutual recognition procedures and centralised or decentralised procedures, without excluding conditional MAs.

109As the EMA rightly asserts, the placing on the market of the Comirnaty vaccine necessarily required an authorisation, in accordance with Article 6(1) 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. The conditional nature of that authorisation in no way supports the conclusion that it is not an MA within the meaning of the disclosure guidance document.

110Furthermore, as the interveners correctly point out, the procedure for the designation of a medicinal product as an orphan medicinal product, which is excluded from the scope of the disclosure guidance document, is a specific procedure governed by Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products (OJ 2000 L 18, p. 1). A specific procedure of that kind cannot be confused with the MA procedure for such a medicinal product, whether that procedure is ‘ordinary’ or conditional. Thus, the fact that the medicinal products designated as orphan medicinal products may, like the Comirnaty vaccine, be subject to a conditional MA procedure is irrelevant in the present case.

111As regards the applicant’s argument based on the information in the table annexed to the disclosure guidance document, concerning Sub-module 1.5 entitled ‘Specific requirements for different types of applications’, it is apparent from that part of the table that the information referred to relating to conditional MAs ‘can be released’, as is apparent from line 1.5.5. of that table.

112That said, as the EMA correctly points out, Module 1 of the dossier relating to the application for authorisation contains only general information of an administrative nature, as is explicitly clear from its title and from volume 2B of the EMA guidance for applicants for authorisations concerning medicinal products for human use, and in particular the presentation and format of the dossier. The fact that general information under Sub-module. 1.5.5 may be disclosed does not therefore mean that the detailed information relating to the characterisation of a medicinal product which is the subject of a conditional MA must be disclosed.

113Consequently, the first part of the first plea in law must be rejected as unfounded.

(d)The third part of the first plea in law, relating, in essence, to infringement of the disclosure guidance document and the EMA’s failure to observe its mandate and powers

114The applicant submits, in essence, that, by granting generalised protection to control strategy data as trade secrets, the EMA infringed Sections 3.1.1 and 3.1.2 of the disclosure guidance document, which require a higher degree of transparency and disclosure for those data. That is all the more so given that the Comirnaty vaccine should be classified as a biotechnological product, subject to even stricter transparency requirements.

115Moreover, the EMA is under an obligation to verify, prescribe and impose quality criteria as provided for, inter alia, in Article 8(3)(h) of Directive 2001/83. Important quality criteria, such as the characterisation of the active substance and the finished product, in particular for a critical medicinal product, should therefore be disclosed, in the interests of legal certainty and sound administration.

116By refusing to disclose all the SO1(a) information contained in the documents at issue, the EMA is relying on secret and arbitrary authorisation criteria and is concealing from the public data relating to the quality and safety of the Comirnaty vaccine. The EMA is therefore failing to observe its public service mission, its mandate and its powers as a regulatory authority.

117Furthermore, in accordance with Section 3.1.2 of the disclosure guidance document, the EMA is required to provide a precise statement of reasons as to how the detailed information on the test methods used and the criteria for definition and quantitative acceptance differ from certain monographs of the European pharmacopoeia or another national pharmacopoeia, as it is only on that condition that a trade secret may be invoked in the context of ordinary authorisations.

118The EMA, supported by the interveners, disputes the applicant’s arguments.

119In the present case, in the first place, it is true that the second subparagraph of Section 3.1.1 of the disclosure guidance document states that the final qualitative formulation (composition) of the authorised product does not constitute commercially confidential information. However, the first subparagraph of that point clearly explains that, in principle, information on pharmaceutical development, including detailed data concerning the active substance, formulation, manufacture, test procedures and validation, is confidential.

120It is also apparent from the second and fourth subparagraphs of Section 3.1.2 of the disclosure guidance document that information on the structure of the active substance and the general description of the types of test methods used and the appropriateness of the specification do not constitute commercially confidential data. However, the first and fourth subparagraphs of that point state that detailed information relating to the synthesis or manufacture of the active substance, the test methods used, the specification and the quantitative acceptance criteria are confidential.

121As is apparent from paragraphs 81 and 82 above, the detailed data which remain redacted in the documents at issue relate specifically to the methods and results of tests relating to the quality of the Comirnaty vaccine and its control, which concern its manufacture.

122In the second place, the fifth subparagraph of Section 3.1.2 of the disclosure guidance document, which concerns biotechnological products, also does not state that all information relating to quality and the control strategy must be disclosed. According to that subparagraph, only information of a general nature is considered to be non-confidential, unlike detailed data.

123In the third place, the fourth subparagraph of Section 3.1.2 of the disclosure guidance document admittedly provides for an exception to the confidential nature of detailed information on the test methods used, where the tests are covered by specific monographs of the European pharmacopoeia.

124That being so, in the contested decision, the EMA emphasised that the mRNA technology used in the manufacture of the Comirnaty vaccine constituted a new technology in respect of which there was practically no industrial experience, which the applicant did not in any way dispute. In other words, the testing methods and quality control strategy developed for the Comirnaty vaccine relating to that new technology had no precedent and were the result of the know-how specific to the holder of the conditional MA for that vaccine. As the EMA confirmed at the hearing, that explanation in itself answers the question whether the tests carried out already corresponded to the common methods compiled in the European pharmacopoeia.

125In adopting the contested decision, the EMA did not therefore infringe its own disclosure guidance document.

126In the fourth place, by refusing to disclose the redacted data, the EMA did not rely on secret and arbitrary authorisation criteria to grant the MA for the Comirnaty vaccine. A large part of the detailed SO1(a) data in the documents at issue had been disclosed, including the specific conclusions relating to the results of the tests conducted at the EMA’s request. Compliance with the criteria laid down in Directive 2001/83 for the grant of an MA for the Comirnaty vaccine had also been verified, as is apparent from the numerous assessment reports published on the EMA’s website.

127In the light of the foregoing, the applicant cannot claim that the EMA failed to observe its public service mission, its mandate and its powers by refusing to disclose the redacted data.

128Consequently, the third part of the first plea in law must be rejected as unfounded.

(e)The sixth part of the first plea in law, alleging, in essence, that the redacted data belong to the public domain, disproportionate redaction and that BioNTech’s commercial interests were not undermined

129The applicant submits, in essence, that neither of the two conditions required for the redacted data to be classified as constituting BioNTech’s ‘trade secrets’, namely the non-public nature of those data and the harm to BioNTech’s commercial interests in the event of disclosure, is satisfied.

130In the first place, the redacted data, which relate to the MA criteria for the Comirnaty vaccine, are already in the public domain simply because, in essence, they relate to the quality of the Comirnaty vaccine and they had been submitted to the EMA. A parallel should be drawn here with the field of intellectual property, where the holder of a patent is required to disclose detailed information in order to obtain protection for that patent. The applicant argues that there is a lack of knowledge with regard to quality requirements and that the EMA has nevertheless emphasised their relevance in terms of safety.

131In his observations on the statement in intervention, the applicant adds, first, that the EMA report disclosed on 14 July 2022 demonstrates that the contested decision is disproportionate and legally flawed. Second, he points out that a part of the redacted data in the documents at issue appears in a 152-page Pfizer-BioNTech document entitled ‘M3-20-Nov-2020-FDA-Query-Responses’ (‘the Pfizer-BioNTech document’), available on the internet. In addition, other scientific publications confirm the public nature of the redacted content.

132In the second place, the applicant complains that the EMA failed to explain to what extent disclosure of the redacted data could specifically adversely affect BioNTech. Indeed, the considerable profits made by that undertaking show that it may never be adversely affected in the next 30 years. Thus, the EMA should have stated that its trade secrets no longer exist, especially since control strategies are not systematically considered as trade secrets by the disclosure guidance document.

133The EMA, supported by the interveners, disputes the applicant’s arguments.

134As a preliminary point, it should be recalled that, in the light of paragraphs 29 to 36 above, the applicant’s line of argument in the context of the sixth part of the first plea is effective only in so far as it concerns the data which remain redacted after the correcting decision was adopted.

135In the present case, in the first place, the mere fact that the redacted data had been provided to the EMA in the context of a conditional MA application cannot have the consequence that those data automatically belong to the public domain and that the first indent of Article 4(2) of Regulation No 1049/2001 was infringed. Such an assertion would deprive that Article 4 of all substance. The same is true for the fact that the redacted data relate to the quality of the vaccine, in so far as, as in the present case, those data relate to new technology and are commercially confidential.

136As regards the parallel that should be drawn with the field of intellectual property, the applicant does not cite any specific provision in support of his argument and does not substantiate it. The same applies to the allegation that BioNTech had licensed the mRNA technology under many patents and sub-patents. Although the applicant refers the Court back to a document provided in a footnote, he does not substantiate his claim in any way and does not, in particular, explain which information BioNTech itself disclosed within the meaning of Regulation No 1049/2001 and which is thus public.

137Furthermore, as regards the consequences of the applicant’s discovery of the EMA report disclosed on 14 July 2022 and the Pfizer-BioNTech document, the following should be noted.

138First, as regards the applicant’s argument that the content of the EMA report disclosed on 14 July 2022 demonstrated that the contested decision was disproportionate and legally flawed, it must be held that that argument is unsubstantiated and does not satisfy the requirements of clarity and precision required by Article 76(d) of the Rules of Procedure.

139In any event, on 7 February 2024, the EMA adopted the correcting decision in order to take account of the EMA report disclosed on 14 July 2022 and to correct the human error found in the contested decision. The fact that the EMA was required to disclose the data contained in that report on the sole ground that those data had already been made public in no way calls into question, in itself, the confidential nature of the information which remains redacted in the documents at issue.

140Second, it is apparent from the information in the file that the EMA was the subject of cyberattacks during the year 2021, which led to the leak of several documents. In addition, as the applicant acknowledges, the Pfizer-BioNTech document was published on a website dedicated to ‘conspiracy theories’ linked to the COVID-19 pandemic, under a tab entitled ‘EMA leaked papers’. That information shows that the downloading of the Pfizer-BioNTech document is very likely the result of a cyberattack against the EMA, which the interveners confirmed.

141The unauthorised disclosure of a document cannot have the effect of granting public access to a document covered by one of the exceptions provided for in Article 4 of Regulation No 1049/2001 (see, to that effect, judgment of 25 October 2013, Beninca v Commission, T‑561/12, not published, EU:T:2013:558, paragraph 55; see also, to that effect and by analogy, judgment of 6 October 2021, Aeris Invest v ECB, T‑827/17, EU:T:2021:660, paragraph 219).

142Consequently, in so far as the applicant does not put forward any evidence to support the conclusion that the Pfizer-BioNTech document had been lawfully disclosed to the public, the Court cannot, in any event, act on the basis of that document to consider the applicant’s argument as valid and thus to conclude that the contested decision is unlawful, without it being necessary to rule on the admissibility of that document.

143Nor can the applicant argue that it was for the EMA itself to conduct its own research, or that it could have found the Pfizer-BioNTech document, given that such an argument is ineffective. In the light of the case-law referred to in paragraph 141 above, the discovery of that document by the EMA does not, however, make the disclosure of the information it contains lawful and cannot compel the EMA to disclose the information concerned to the applicant.

144In his observations on the statement in intervention, the applicant also cites a number of scientific publications which confirm the public nature of the redacted content. However, those documents, which were not cited by the applicant in the application, were produced at a late stage of the proceedings without the slightest justification for that delay. In accordance with Article 85(3) of the Rules of Procedure, those documents must therefore be regarded as constituting belated evidence and, therefore, inadmissible.

145In the second place, as is apparent from paragraph 99 above, the EMA put forward relevant reasons in the contested decision to justify the application of the exception laid down in the first indent of Article 4(2) of Regulation No 1049/2001. Contrary to what the applicant suggests, that regulation in no way requires that the alleged harm to the commercial interests must be quantified, or that the EMA examine the market situation specifically to quantify it. Indeed, it is sufficient that such harm is reasonably foreseeable and not purely hypothetical.

146In that context, the turnover and profits made by the holder of the conditional MA are not relevant for the purpose of assessing the confidential nature of the redacted data, given that the disclosure of such data, which constitutes sensitive information emphasising that holder’s expertise, would confer an advantage on competitors and would thus undermine the commercial interests of that holder, within the meaning of the case-law cited in paragraph 75 above.

147It follows from the foregoing that the sixth part of the first plea in law must be rejected as unfounded.

(f)The seventh part of the first plea in law, relating to the assumptions made by the EMA as to the context of the application for access

148The applicant claims that the EMA erred in law by analysing the context of the application for access and by framing it within in the context of a general questioning of the safety of the Comirnaty vaccine. In so doing, the EMA is thus making irrelevant observations on safety and the grant of a conditional MA. Regulation No 1049/2001 does not subject the right of access to documents to a justification of the submitted application. In addition, the protection of the data requested as trade secrets came to an end as soon as the application for a conditional MA was lodged.

149The EMA and the interveners did not respond to those arguments.

150In the present case, it should be noted that the applicant’s line of argument is based on the premiss that, in order to refuse to disclose all the documents at issue, the EMA took into account the context of the application for access, in particular the fact that it calls into question the safety of the Comirnaty vaccine.

151In that regard, while it is true that, in the contested decision, the EMA emphasised the need, including in the context of a conditional MA, to comply with quality standards imposed in the EU, it in no way relied on such assertions in order to examine the confidential nature of the redacted data. As is apparent from the first three pages of that decision, the EMA justified its refusal to disclose by the very nature of the data concerned and by the harm which their disclosure would cause to BioNTech’s commercial interests.

152In paragraph 4 of the contested decision, the EMA also stated that it understood that, according to the applicant, there were ‘unknowns’ concerning the safety and efficacy of the Comirnaty vaccine. However, that statement was made in the context of the assessment of the existence of an overriding public interest, within the meaning of the last sentence of Article 4(2) of Regulation No 1049/2001, and not of the harm to BioNTech’s commercial interests pursuant to the first indent of Article 4(2) of that regulation.

153Given that it seeks to demonstrate infringement of the first indent of Article 4(2) of Regulation No 1049/2001, the argument must be dismissed as having no factual basis.

154In the light of the foregoing, the seventh part of the first plea in law must be rejected, as must, therefore, the first plea in its entirety.

2.The second plea in law, alleging infringement of the last sentence of Article 4(2) of Regulation No 1049/2001 and of the existence of an overriding public interest in disclosure

155In support of his second plea, the applicant puts forward four parts. First, he claims that the EMA misinterpreted the applicant’s arguments seeking to demonstrate the existence of an overriding public interest. Second, the EMA applied an incorrect criterion to assess the existence of an overriding public interest. Third, the EMA breached the principle of maximum transparency applicable to medical countermeasures. Fourth, the EMA failed to take into account the case-law of the Court of Justice on the public interest of laboratory data in the context of environmental protection, nor the provisions of the Agreement on Trade-Related Aspects of Intellectual Property Rights (OJ 1994 L 336, p. 214; ‘the TRIPS Agreement’), which forms part of the World Trade Organisation (WTO) agreements, signed by representatives of the European Community and approved subsequently by Council Decision 94/800/EC (of 22 December 1994) concerning the conclusion on behalf of the European Community, as regards matters within its competence, of the agreements reached in the Uruguay Round multilateral negotiations (1986-1994) (OJ 1994 L 336, p. 1).

(a)The first part of the second plea in law, alleging misinterpretation of the applicant’s arguments

156The applicant claims that, in the context of the examination of the existence of an overriding public interest in full disclosure of the documents at issue, the EMA relied on a misunderstanding of the applicant’s arguments, by reducing them in an unsubstantiated manner to unknowns about the vaccine and informed patient consent. In his email of 4 May 2022, the applicant rather drew attention to the EMA’s relatively long response times, to the conditional nature of the MA of the Comirnaty vaccine and to the fact that COVID-19 vaccines and medicinal products were classified as ‘a global public good’.

157The EMA, supported by the interveners, disputes the applicant’s arguments.

158In the present case, as is apparent from the last two sentences of the applicant’s email addressed to the EMA on 8 April 2022, the applicant explicitly argued the existence of an overriding public interest in disclosure by emphasising the context of the pandemic, the fact that the tests submitted had not been completed, the existence of uncertainties and the need to ensure informed patient consent. He also pointed out that the EMA was required to safeguard the health of EU citizens.

159Taking into account the wording used in the email of 8 April 2022, the need to ensure informed patient consent in a context characterised by specific uncertainties and unfinished tests, and to safeguard the health of EU citizens, was correctly construed by the EMA as corresponding to arguments relating to the protection of an overriding public interest.

160Moreover, in the context of the application’s second plea in law, the applicant repeatedly stresses the need to safeguard public health and to ensure the safety of medicinal products. The applicant himself concludes, at the end of the application, that public health should be given priority over BioNTech’s trade secrets.

161By contrast, in his email of 4 May 2022, the applicant did not mention any overriding public interest capable of justifying the disclosure of all the documents at issue. First of all, he challenged the EMA policy on time limits for replying to applications for access. He then argued that the EMA could not rely on the principles applicable to applications for access relating to ordinary MAs in order to limit access to the documents at issue, he emphasised that it was unlawful to authorise medicinal products on the basis of unfinished tests and he referred back to the pleadings submitted by the EMA in the case which gave rise to the order of 8 July 2022, Agentur für Globale Gesundheitsverantwortung v EMA (T‑713/21, not published, EU:T:2022:432), which was subsequently removed from the General Court’s register. None of those arguments makes it possible to identify the overriding public interest on which the applicant seeks to rely. Lastly, the applicant claimed that the COVID-19 vaccines were a global public good. Such an argument is, however, too vague and did not enable the EMA to understand its scope.

162Consequently, contrary to what the applicant claims, the EMA did not misinterpret the arguments which he had put forward in his emails of 8 April and 4 May 2022 in order to obtain access to the documents at issue.

163The first part of the second plea in law must therefore be rejected.

(b)The second part of the second plea in law, alleging the application of an incorrect criterion for the assessment of the existence of an overriding public interest

164In the first place, in essence, the applicant submits that the EMA erred in law by examining the subjective purpose of his application for access and by failing to examine whether the disclosure of the information contained in the documents at issue could, in the light of their content or quality, satisfy an overriding public interest. In that regard, the EMA should not have confined itself to examining the arguments relied on by the applicant in support of his application for access, but was required to verify whether there was an overriding public interest in view of the public nature of data relating to a medical countermeasure. The EMA should also have taken account of the conditional nature of the MA for the Comirnaty vaccine and of the associated transparency requirements, as well as the inapplicability of the ordinary procedure for access to documents.

165In the second place, according to the applicant, the EMA wrongly assumed that the general public would not gain any further knowledge about the safety and efficacy of the Comirnaty vaccine in the event of disclosure of the redacted data.

166In the third place, the applicant submits that data relating to a medical countermeasure must be considered intrinsically public, by analogy with Article 6(1) of Regulation (EC) No 1367/2006 of the European Parliament and of the Council of 6 September 2006 on the application of the provisions of the Aarhus Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters to [EU] institutions and bodies (OJ 2006 L 264, p. 13).

167The EMA, supported by the interveners, disputes the applicant’s arguments.

168As a preliminary point, it should be recalled that under Article 4(2) of Regulation No 1049/2001 the EU institutions are to refuse access to a document where its disclosure would undermine the protection ‘of commercial interests of a natural or legal person, including intellectual property’ (the first indent of Article 4(2) of that regulation), unless there is an overriding public interest in disclosure (the last line of Article 4(2) thereof).

169It follows that the system of exceptions laid down in Article 4(2) of Regulation No 1049/2001 is based on a balancing of the opposing interests in a given situation, that is to say, first, the interests which would be favoured by the disclosure of the documents in question and, secondly, those which would be jeopardised by such disclosure. The decision taken on an application for access to documents depends on which interest must prevail in the particular case (see judgment of 7 September 2023, Breyer v REA, C‑135/22 P, EU:C:2023:640, paragraph 72 and the case-law cited).

170In that regard, it is for the applicant to rely on specific circumstances to show that there is an overriding public interest which justifies the disclosure of the documents concerned (see judgments of 14 November 2013, LPN and Finland v Commission, C‑514/11 P and C‑605/11 P, EU:C:2013:738, paragraph 94 and the case-law cited, and of 16 July 2015, ClientEarth v Commission, C‑612/13 P, EU:C:2015:486, paragraph 90 and the case-law cited). Although the overriding public interest capable of justifying the disclosure of a document need not necessarily be distinct from the principles which underlie Regulation No 1049/2001, general considerations alone are not capable of establishing that the principle of transparency is of particularly pressing concern and capable, therefore, of prevailing over the reasons justifying the refusal to disclose the documents (see judgment of 7 September 2023, Breyer v REA, C‑135/22 P, EU:C:2023:640, paragraph 75 and the case-law cited).

171In other words, the person intending to object to a reason for refusing disclosure must assert the existence of a public interest capable of prevailing over that reason and, moreover, demonstrate precisely that, in the particular case, disclosure of the documents concerned would contribute specifically to ensuring the protection of that public interest to the extent that the principle of transparency prevails over the protection of the interests that provided the basis for the refusal to disclose, namely, in the present case, the protection of the commercial interests of the holder of the conditional MA (see, to that effect and by analogy, judgment of 9 October 2018, Erdősi Galcsikné v Commission, T‑632/17, not published, EU:T:2018:664, paragraph 41).

172Thus, in the first place, although it is true that it is for the person making an application to rely on specific circumstances justifying the disclosure of specific data, such a requirement cannot be interpreted as meaning that the person making an application for access must justify that application, that is to say, that he or she must indicate in that application the grounds or reasons why he or she is making such an application (see, to that effect, judgment of 5 October 2022, Múka v Commission, T‑214/21, not published, EU:T:2022:607, paragraph 66). On the other hand, it follows from that requirement that it was not for the EMA, in the present case, to examine of its own motion any evidence which might have justified the existence of an overriding public interest, irrespective of any arguments put forward by the applicant.

173In addition, it is apparent from Section 4 of the contested decision that the EMA examined the existence of an overriding public interest in disclosure of the redacted data in the light of the need to ensure the safety of the Comirnaty vaccine and informed patient information. As is apparent from paragraph 162 above, those are the specific arguments put forward by the applicant in the confirmatory application to demonstrate the existence of such an interest. The EMA therefore, in accordance with the settled case-law referred to in paragraphs 170 and 171 above, analysed the arguments put forward by the applicant and in no way based its response on a possible subjective purpose pursued by him.

174In the second place, as regards the EMA’s assertion that the general public would not gain any further knowledge about the safety and efficacy of the Comirnaty vaccine in the event of disclosure of the redacted data, it should be borne in mind that that response relates to the applicant’s explicit arguments relating to the need to ensure informed patient consent in a context characterised by specific uncertainties and unfinished tests, and to safeguard the health of EU citizens.

175In that regard, there is no doubt that informed patient information and the need to ensure safe and quality vaccines are in the public interest. However, the applicant has in no way explained, in detail, how the EMA’s response is vitiated by an error in the light of his arguments. In particular, the applicant has not indicated in any way how the partial disclosure of the documents at issue by the EMA did not sufficiently safeguard those interests, even though (i) a large amount of information had already been disclosed, (ii) the conclusions drawn on the basis of those data as regards SO1(a) had been disclosed, (iii) the data which remained redacted were relatively limited, precise and technical and (iv) after weighing BioNTech’s specific commercial interests which had to be protected by non-disclosure of the data concerned against the public interest in those data being made accessible, the EMA had set out in the contested decision that disclosure of those data would be of use only to BioNTech’s direct competitors.

176In the third place, the applicant does not set out the reasons why the data relating to a medical countermeasure should be considered intrinsically public, by analogy with Article 6(1) of Regulation No 1367/2006. Since it is not substantiated, the argument must therefore be rejected.

177Consequently, the second part of the second plea in law must be rejected as unfounded.

(c)The third part of the second plea in law, alleging breach of the principle of transparency applicable to medical countermeasures

178The applicant claims that, in the contested decision, the EMA breached the principle of maximum transparency which prevails in relation to medical countermeasures. The EMA ignored the legal nature of SO1(a), linked to the conditional nature of the MA for the Comirnaty vaccine, and the particular role required by Regulation 2022/123 in the presence of measures aimed at preserving global health security in the event of a health emergency. In that regard, the Comirnaty vaccine was placed at the top of the ‘list of critical medicines for COVID-19 public health emergency’. The EMA has a critical role to play in terms of security of supply and quality, which also requires it to exhibit enhanced transparency, as is apparent from Regulation No 507/2006 and Regulation 2022/123. Thus, the EMA erred in law by examining irrelevant aspects concerning the safety of the vaccine, while maintaining redactions largely in accordance with the administrative rules for ordinary medicinal products.

179The EMA, supported by the interveners, disputes the applicant’s arguments.

180In the present case, it must be held that, as elaborated in the application, the applicant’s arguments concerning (i) the context of the COVID-19 pandemic, (ii) the conditional nature of the MA, (iii) the critical role of the EMA and (iv) the classification of the Comirnaty vaccine as a medical countermeasure relate, in essence, to a requirement of general transparency which is applicable to the documents at issue.

181In that regard, as is apparent from the examination of the first part of the second plea above, the EMA did not err in examining the existence of an overriding public interest in the light of the need to ensure informed patient consent and to safeguard the health of EU citizens, with regard to the arguments elaborated by the applicant in the confirmatory application. The EMA cannot therefore be criticised for not having examined, in addition, the applicant’s arguments put forward in the application which relate to the principle of transparency per se.

182It is therefore for the sake of completeness, if it should be held that the EMA was required to take into account the principle of transparency per se, that the Court examines below the applicant’s arguments referred to in paragraph 180 above.

183In that regard, it should be observed that the overriding public interest referred to in the last sentence of Article 4(2) of Regulation No 1049/2001, in consideration of which documents must be disclosed under that provision, must be distinct from the principle of transparency. That being so, the fact that a party requesting access does not invoke a distinct public interest distinct from the principle of transparency does not automatically imply that it is unnecessary to weigh up the interests at stake. The invocation of that same principle may, in the light of the particular circumstances of the case, be so pressing that it overrides the need to protect the documents in question (judgment of 12 September 2007, API v Commission, T‑36/04, EU:T:2007:258, paragraph 97).

184Therefore, it is only where the particular circumstances of the case substantiate a finding that the principle of transparency is especially pressing that that principle can constitute an overriding public interest capable of prevailing over the need for protection of the commercial interests of the undertakings and, accordingly, capable of justifying the disclosure of the redacted data in the present case in accordance with the last line of Article 4(2) of Regulation No 1049/2001 (judgment of 25 March 2015, Sea Handling v Commission, T‑456/13, not published, EU:T:2015:185, paragraph 101).

185In the case of medicinal products such as the Comirnaty vaccine, which was developed in the exceptional context of the COVID-19 pandemic, the public has a clear interest in being informed of the essential elements of the EMA’s action regarding the grant of a conditional MA. However, the existence of that public interest does not oblige the EMA to grant generalised access, on the basis of Regulation No 1049/2001, to any detailed information obtained from the holder of the conditional MA in the context of such a procedure.

186Indeed, such generalised access would jeopardise the balance which the EU legislature sought to ensure, in Regulation No 507/2006, read in conjunction with Regulation No 726/2004, between the obligation on the applicant for an MA to communicate to the EMA sensitive commercial information and the guarantee of increased protection, by virtue of the requirement of professional secrecy and business secrecy, for the information so provided to the EMA.

187In addition, as the EMA and the interveners have argued, in the particular context of the COVID-19 pandemic, a large amount of information has been published by the EMA concerning the Comirnaty vaccine, including regular interim assessments and safety updates, which the applicant does not dispute. Measures to ensure a high degree of transparency with regard to that vaccine, including its quality, have therefore already been adopted, precisely in view of the exceptional context in which that conditional MA had been granted for that vaccine.

188Moreover, in view of the precise and technical nature of the redacted data, it was impossible for the EMA to provide a summary of those data in a form which could have satisfied the applicant’s application for access. Furthermore, although several tables of test results and certain explanations remain redacted in the documents at issue, the fact remains that the conclusions drawn from those results, which were subsequently verified by the EMA, have been disclosed. Thus, the public may understand those conclusions in the light of the explanations relating to SO1(a) set out in the EMA’s public assessment reports on the Comirnaty vaccine, in particular the report referred to in paragraph 4 above, in order to ensure that the data requested by the EMA were indeed provided to it.

189In the application, the applicant does not put forward any specific arguments to explain why, despite the exceptional transparency measures adopted by the EMA in the context of the COVID-19 pandemic in general and the disclosure, in the present case, of the conclusions drawn from the specific redacted data, the principle of transparency in itself should have prevailed over the protection of BioNTech’s commercial interests and led to the disclosure of all those data.

190It should be added that general considerations on the protection of human health cannot either provide an appropriate basis for establishing that, in the present case, the principle of transparency was especially pressing and capable, therefore, of prevailing over the reasons justifying the refusal to disclose the documents in question (see, to that effect and by analogy, judgments of 14 November 2013, LPN and Finland v Commission, C‑514/11 P and C‑605/11 P, EU:C:2013:738, paragraph 93, and of 16 July 2015, ClientEarth v Commission, C‑612/13 P, EU:C:2015:486, paragraph 93).

191Consequently, the applicant has not demonstrated that the need to ensure transparency constituted, in the present case, an overriding public interest within the meaning of Article 4(2) of Regulation No 1049/2001 justifying the disclosure of the detailed data at issue.

192Furthermore, while it is true that Regulation 2022/123 confers a particular role on the EMA in order to safeguard global health security in the event of a health emergency, it in no way calls into question the principles laid down in Regulation No 1049/2001 or the need to protect the commercial interests of MA holders. On the contrary, as is apparent from paragraph 96 above, that protection is emphasised by Article 17 of Regulation 2022/123. The confidentiality of the data submitted to the EMA is also explicitly reaffirmed in Article 34 of that regulation, which provides that all parties involved are to respect the confidentiality of information and data obtained in carrying out their tasks in order to protect the commercially confidential information and trade secrets of natural or legal persons, including intellectual property rights.

193No further obligation of enhanced transparency follows from Regulation No 507/2006, as is apparent from paragraphs 89 to 91 above.

194Consequently, the third part of the second plea in law must be rejected as unfounded.

(d)The fourth part of the second plea in law, alleging failure to take into account the case-law of the Court of Justice relating to the public interest of laboratory data in the context of environmental protection and the provisions of the TRIPS Agreement

195The applicant considers that account should be taken of the Court’s case-law relating to the public interest of laboratory data in the context of environmental protection, which has a very close connection with the field of health and the safety of medicinal products within the framework of the approach entitled ‘One Health’. It submits that, in accordance with the Court’s case-law, the TRIPS Agreement allows disclosure of data submitted by an applicant for an MA of a pharmaceutical or chemical product where that disclosure is necessary to protect the public.

196In the context of the present case, taking into account the nature of SO1(a) and in the light of WHO standards on mRNA technology, that would mean that disclosure of quality-related data would be definitively necessary for the protection of the public.

197The EMA, supported by the interveners, disputes the applicant’s arguments.

198In the present case, it should be noted that, in the confirmatory application, the applicant did not rely on the arguments which he now puts forward in support of the fourth part of the second plea in order to demonstrate the existence of an overriding public interest in disclosure. Taking into account the case-law referred to in paragraph 170 above, which requires the person making an application for access to state the circumstances justifying the disclosure of the specific data concerned, the EMA cannot be criticised for not having taken such arguments into account in its assessment of the existence of an overriding public interest in disclosure.

199In any event, it is true that, according to the only judgment cited in the application, Article 39(3) of the TRIPS Agreement allows disclosure of data submitted by an applicant for an MA of a pharmaceutical or chemical product where necessary to protect the public (judgment of 23 November 2016, Bayer CropScience and Stichting De Bijenstichting, C‑442/14, EU:C:2016:890, paragraph 98). Nevertheless, the fact that disclosure may be granted where it is necessary to protect the public does not relieve the applicant for an MA of the burden of proving the existence of such a necessity.

200In that regard, the applicant once again refers to WHO standards on mRNA technology and to the context of the present case to demonstrate that the requested data, which concern the quality and safety of the Comirnaty vaccine, must be disclosed in order to protect the public. As it is, that vague and general line of argument does not demonstrate why, contrary to what the EMA stated in the contested decision, partial disclosure of the documents at issue was not sufficient, specifically, to ensure informed patient information and to protect public health. Moreover, as is apparent from paragraph 187 above, the EMA published information concerning the safety and efficacy of the Comirnaty vaccine, which the applicant does not dispute.

201In addition, the applicant’s arguments based on the existence of increased disclosure requirements in WHO standards on mRNA technology have been rejected in paragraphs 97 and 98 above. As regards the fact that the redacted data relate to a specific obligation, it is apparent from paragraphs 174 and 186 above that that argument cannot succeed either.

202Accordingly, the fourth part of the second plea in law is unfounded and must be rejected, as must the second plea in its entirety.

203It follows from all of the foregoing, first, that there is no longer any need to adjudicate on the application for annulment of the contested decision in so far as it relates to data disclosed after correction, and second, that the remainder of the action must be dismissed as unfounded.

V.Costs

204Under Article 134(1) of the Rules of Procedure, the unsuccessful party is to be ordered to pay the costs if they have been applied for in the successful party’s pleadings.

205Moreover, under Article 135(2) of the Rules of Procedure, the Court may order a party, even if successful, to pay some or all of the costs, if this appears justified by the conduct of that party, including before the proceedings were brought, especially if he or she has made the opposite party incur costs which the Court holds to be unreasonable or vexatious. Furthermore, under Article 137 of those rules, where a case does not proceed to judgment, the costs are to be in the Court’s discretion.

206In the present case, following the discovery of information by the applicant himself, the EMA acknowledged during the proceedings that it had erred in the contested decision by redacting certain data which had, however, already been disclosed pursuant to Regulation No 1049/2001. That conduct on the part of the EMA, which corrected the contested decision only more than 18 months after the adoption of that decision, is evidence of a lack of diligence in dealing with the applicant’s file.

207Furthermore, the correction of such an error by the adoption of the correcting decision resulted in the applicant having to submit additional observations. For those reasons, the Court considers that a fair apportionment of the costs will be made by ordering the EMA to bear its own costs and to pay half of the applicant’s costs.

208Moreover, under Article 138(3) of the Rules of Procedure, the Court may order an intervener other than those referred to in paragraphs 1 and 2 of that article to bear its own costs. In the present case, it is appropriate to decide that the interveners must bear their own costs.

Operative part

On those grounds,THE GENERAL COURT (Fourth Chamber, Extended Composition)hereby

1.Declares that there is no longer any need to adjudicate on the action in so far as it concerns the data disclosed by the European Medicines Agency (EMA) following the adoption of the correcting decision contained in its letter of 7 February 2024 bearing reference EMA/55289/2024;

2.Dismisses the action as to the remainder;

3.Orders the EMA, in addition to bearing its own costs, to pay half of SD’s costs;

4.Orders SD to bear half of his own costs;

5.Orders BioNTech SE, BioNTech Manufacturing GmbH and BioNTech Manufacturing Marburg GmbH to bear their own costs.

Delivered in open court in Luxembourg on 19 November 2025.