62022TJ0623_RES
Case T‑623/22
SDvEuropean Medicines Agency
Judgment of the General Court (Fourth Chamber, Extended Composition) of 19 November 2025
(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 of 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)
Action for annulment – Time limits – Point from which time starts to run – Date of notification of the decision – Date on which a measure came to the knowledge of the applicant – Application for access to documents – Documents originating from a third party – Disclosure decision notified, without immediate or automatic communication of the documents – Disclosure of the documents following consultation of the third party and possible proceedings brought by that third party before the EU judicature – Time starting to run from the date of the actual notification of the documents at issue
(Arts 263, sixth para., and 297(2), third subpara., TFEU; European Parliament and Council Regulation No 1049/2001, Art. 4(4))
(see paragraphs 19, 20, 24, 25)
Action for annulment – Natural or legal persons – Interest in bringing proceedings – Action brought against a decision of an EU agency granting only partial access to requested documents – Prior disclosure of certain data on the occasion of an application for access to documents made by a third party – Redactions maintained for other data – Continued interest in bringing proceedings
(Art. 263, fourth subpara., TFEU; European Parliament and Council Regulation No 1049/2001, Art. 10(1) and (2))
(see paragraphs 29-31, 34-36)
EU institutions – Right of public access to documents – Regulation (EC) No 1049/2001 – Obligation to formulate an application for access in a sufficiently precise manner – Obligation for the person making an application for access to satisfy himself or herself that the requested documents were communicated – Obligation to define the scope of the confirmatory application for access
(European Parliament and Council Regulation No 1049/2001, Arts 7 and 8)
(see paragraphs 52-54)
EU institutions – Right of public access to documents – Regulation (EC) No 1049/2001 – Exceptions to the right of access to documents – Protection of the commercial interests of a third party – Refusal to grant access – Obligation to state reasons – Scope – Demonstration of the existence of a reasonably foreseeable and not merely hypothetical risk of undermining a protected interest
(European Parliament and Council Regulation No 1049/2001, recital 11 and Art. 4(2), first indent)
(see paragraphs 72-75, 145)
EU institutions – Right of public access to documents – Regulation (EC) No 1049/2001 – Exceptions to the right of access to documents – Protection of the commercial interests of a third party – Scope – Redacted data corresponding to numerical results of tests associated with the characterisation of the active substance of a COVID-19 vaccine and the parameters used for those tests – Sensitive commercial information which could undermine the protection of commercial interests – Included
(European Parliament and Council Regulation No 1049/2001, recital 11 and Art. 4(2), first indent)
(see paragraphs 81-87, 99)
EU institutions – Right of public access to documents – Regulation (EC) No 1049/2001 – Exceptions to the right of access to documents – Protection of commercial interests – Overriding public interest justifying the disclosure of documents – Invocation of the principle of transparency – Need to put forward particular considerations in relation to the case
(European Parliament and Council Regulation No 1049/2001, Art. 4(2))
(see paragraphs 169-172, 175, 183-186, 190, 191)
Résumé
Hearing an action for annulment which it dismisses, the General Court rules, first, on the question of access to documents containing sensitive data relating to the manufacture of the COVID-19 Comirnaty vaccine and on the possible existence of an overriding public interest in the disclosure of those data. Second, it provides clarification on the starting point of the period prescribed for bringing annulment proceedings against a decision taken by the EMA in response to an application for access to documents, in the light of the specific consultation procedure laid down in Article 4(4) of Regulation No 1049/2001.
In December 2020, the European Commission adopted an implementing decision on the granting of a conditional marketing authorisation for the medicinal product for human use Comirnaty – COVID-19 mRNA vaccine (nucleoside modified). (
1
)
That authorisation was granted to BioNTech Manufacturing GmbH (‘BioNTech’) subject to compliance with certain specific obligations. Under the first of those obligations, BioNTech had to provide additional data in order to complete the characterisation of the active substance and the finished product at issue.
On 28 December 2021, the applicant sent the European Medicines Agency (EMA) an application for access to documents (
2
) concerning, inter alia, part (a) of the first specific obligation referred to above (‘SO1(a)’). In response to that application for access, the EMA stated that it had identified three documents (‘the documents at issue’).
On 8 April 2022, after consulting BioNTech concerning the disclosure of the documents at issue, (
3
) the EMA informed the applicant that he would be granted partial access to those documents (‘the initial decision to grant access’). On 29 April 2022, the EMA sent the applicant the documents at issue, the content of which had been partially redacted. The following month, the applicant made a confirmatory application seeking full disclosure of the documents at issue.
By letter of 21 July 2022, the EMA replied to the applicant that, following re-examination of the initial decision to grant access, the documents at issue could be disclosed to a greater extent, but that a partial redaction of their content was still necessary in order to protect BioNTech’s commercial interests (
4
) (‘the contested decision’). On 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.
It was in those circumstances that the applicant filed an action before the General Court for annulment of the contested decision, brought on 7 October 2022.
In the course of the proceedings, the applicant informed the Court that he had found, by chance while searching the internet, information likely to be analogous to the data redacted in the documents at issue. In response, the EMA explained that that information corresponded, in part, to that contained in an assessment report that it had already disclosed in July 2022, following an application for access to documents lodged by a third party.
Therefore, after acknowledging that that information had already entered the public domain at the time the contested decision was adopted and should therefore have been communicated to him, the EMA corrected the contested decision by agreeing to send the applicant the data that had already been disclosed, while maintaining the other redactions in the documents at issue for the reasons set out in the contested decision.
Findings of the Court
In the first place, with regard to the rules applicable to the calculation of the period for bringing an action for annulment, the Court notes that the date to be taken into account for determining the starting point of such a period is the date of notification of the act in question where it specifies the person to whom it is addressed. (
5
) 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.
In the present case, the EMA implements a specific procedure pursuant to Article 4(4) of Regulation No 1049/2001 when it intends to adopt a decision on an application for access to documents originating from a third party. In such a situation, it informs the third party concerned of its decision to disclose certain information and of the possible legal remedies against that decision. The person concerned then has a time limit of 10 working days in which to notify his or her intention to challenge the proposed disclosure before the Court, in which case the EMA refrains from communicating the documents until the outcome of the proceedings. Furthermore, when it notifies the person making an application of its decision on the application for access, that notification is not accompanied either by immediate or by automatic communication of the requested documents.
Therefore, when the EMA notifies the applicant of its decision on the application for access to documents, the communication of the documents at issue is neither immediate nor automatic and, therefore, that decision can be regarded as having been notified to the applicant in its entirety only once the documents at issue have actually been communicated to him or her.
In that particular context, the Court holds 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, with the result that it is admissible in light of the time limit laid down in the sixth paragraph of Article 263 TFEU.
In the second place, the Court examines the subject matter of the application for access to the documents. In the present case, the applicant complained that the EMA had not communicated to him monthly reports relating to SO1(a).
The Court recalls that provision was made for the application of a two-stage administrative procedure in order ensure the right of public access to documents of the EU institutions. (
6
) That procedure is intended, first, to enable applications for access to documents of the institutions concerned to be dealt with quickly and easily and, second, as a priority, a friendly settlement of disputes which may arise.
In order for that two-stage procedure 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 determine which documents 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.
In the present case, having regard to the explicit and clear reference to the monthly reports in the documents communicated to the applicant and to the wording of his confirmatory application, intended solely to challenge the redactions in the documents at issue, the Court considers that 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 communicated to him the monthly reports which were not mentioned therein.
In the third place, the Court rules on the nature of the information the redaction of which was maintained. Having consulted the full version of the documents at issue, it 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. Those data are therefore information of a highly technical nature obtained through BioNTech’s know-how.
In addition, in the contested decision, the EMA explained that the disclosure of such information would enable competing pharmaceutical companies, using similar technology and operating in the same therapeutic field, to obtain a concrete advantage by saving scientific efforts and human and economic resources.
Consequently, the Court holds that 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 could undermine the protection of BioNTech’s commercial interests.
Furthermore, the Court states that Regulation No 1049/2001 in no way requires that the alleged harm to the commercial interests must be quantified, or that the EMA examine the market situation in order specifically to quantify it. It is sufficient that such harm is reasonably foreseeable and not purely hypothetical.
In the fourth place, in the Court’s view, as regards whether the redacted data may belong to the public domain, the mere fact that the redacted data had been provided to the EMA in the context of a conditional marketing application cannot have the consequence that those data automatically belong to the public domain. Such an assertion would deprive Article 4 of Regulation No 1049/2001 of all substance, in that it provides for the exceptions justifying refusal to grant access to documents. The same is true of 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.
In the fifth place, the Court ascertains whether there is an overriding public interest which could justify the disclosure of the redacted data at issue. In that regard, it notes that the person intending to object to a reason for refusing disclosure must, first, assert the existence of a public interest capable of prevailing over that reason. Second, that person must demonstrate precisely that 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 marketing authorisation.
Although 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 indicate in that application the grounds or reasons why he or she is making such an application. On the other hand, it is not for the EMA to examine of its own motion any evidence which might have justified the existence of an overriding public interest.
In the present case, 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 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 a large amount of information had already been disclosed, the conclusions drawn on the basis of those data as regards SO1(a) had been disclosed and the data which remained redacted were relatively limited, precise and technical. Moreover, after weighing BioNTech’s specific commercial interests which had to be protected by non-disclosure of the data concerned against the public interest in them 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.
In the last place, the Court recalls that 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 case of medicinal products such as the Comirnaty vaccine, 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 marketing authorisation. However, the existence of that public interest does not oblige the EMA to grant generalised access to any detailed information obtained from the holder of that authorisation in the context of such a procedure. Such generalised access would jeopardise the balance which the EU legislature sought to ensure, between the obligation on the applicant for a marketing authorisation to communicate to the EMA sensitive commercial information and the guarantee of increased protection connected, by virtue of the requirement of professional secrecy and business secrecy, to the information so provided to the EMA.
In addition, the Court adds 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 at issue. Consequently, it considers that the applicant has not demonstrated that the need to ensure transparency constituted an overriding public interest justifying disclosure of the redacted data at issue.
In the light of the foregoing, the Court considers that there is no longer any need to adjudicate on the application for annulment of the contested decision in so far as it concerns the data disclosed after correction and dismisses the action as to the remainder.
(
1
)	In accordance with 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 L 136, 30.4.2004, p. 1).
(
2
)	Under Article 4(4) of 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).
(
3
)	Pursuant to Article 4(4) of Regulation No 1049/2001 and document EMA/729522/2016 of 4 October 2018, entitled ‘European Medicines Agency policy on access to documents’.
(
4
)	Under the exception laid down in the first indent of Article 4(2) of Regulation No 1049/2001.
(
5
)	Under the sixth paragraph of Article 263 and the third subparagraph of Article 297(2) TFEU.
(
6
)	As is apparent from the wording of recital 13 of Regulation No 1049/2001.