Abstract;Judgment — ECLI:EU:T:2025:1035
Date: 2025-11-19
Language of the case: German
Court formation: Fourth Chamber, Extended Composition
Procedure: Action for annulment

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’. 90 Recital 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. 91 Furthermore, 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). 92 Second, 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). 93 Third, 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. 94 In 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. 95 Recital 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. 96 However, 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. 97 Fourth, 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. 98 Moreover, 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. 99 Consequently, 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. 100 The 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 101 The 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. 102 The 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). 103 The EMA, supported by the interveners, disputes the applicant’s arguments. 104 In 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). 105 That 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. 106 Thus, the applicant’s argument that the EMA applied a general presumption of confidentiality in the present case has no factual basis. 107 In 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. 108 In 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. 109 As 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. 110 Furthermore, 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. 111 As 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. 112 That 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. 113 Consequently, 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 114 The 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. 115 Moreover, 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. 116 By 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. 117 Furthermore, 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. 118 The EMA, supported by the interveners, disputes the applicant’s arguments. 119 In 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. 120 It 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. 121 As 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. 122 In 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. 123 In 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. 124 That 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. 125 In adopting the contested decision, the EMA did not therefore infringe its own disclosure guidance document. 126 In 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. 127 In 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. 128 Consequently, 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 129 The 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. 130 In 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. 131 In 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. 132 In 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. 133 The EMA, supported by the interveners, disputes the applicant’s arguments. 134 As 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. 135 In 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. 136 As 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. 137 Furthermore, 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. 138 First, 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. 139 In 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. 140 Second, 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. 141 The 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). 142 Consequently, 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. 143 Nor 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. 144 In 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. 145 In 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. 146 In 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. 147 It 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 148 The 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. 149 The EMA and the interveners did not respond to those arguments. 150 In 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. 151 In 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. 152 In 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. 153 Given 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. 154 In 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 155 In 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 156 The 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’. 157 The EMA, supported by the interveners, disputes the applicant’s arguments. 158 In 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. 159 Taking 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. 160 Moreover, 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. 161 By 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. 162 Consequently, 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. 163 The 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 164 In 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. 165 In 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. 166 In 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). 167 The EMA, supported by the interveners, disputes the applicant’s arguments. 168 As 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). 169 It 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). 170 In 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). 171 In 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). 172 Thus, 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. 173 In 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. 174 In 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. 175 In 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. 176 In 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. 177 Consequently, 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 178 The 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. 179 The EMA, supported by the interveners, disputes the applicant’s arguments. 180 In 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. 181 In 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. 182 It 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. 183 In 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). 184 Therefore, 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). 185 In 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. 186 Indeed, 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. 187 In 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. 188 Moreover, 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. 189 In 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. 190 It 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). 191 Consequently, 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. 192 Furthermore, 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. 193 No further obligation of enhanced transparency follows from Regulation No 507/2006, as is apparent from paragraphs 89 to 91 above. 194 Consequently, 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 195 The 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. 196 In 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. 197 The EMA, supported by the interveners, disputes the applicant’s arguments. 198 In 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. 199 In 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. 200 In 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. 201 In 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. 202 Accordingly, the fourth part of the second plea in law is unfounded and must be rejected, as must the second plea in its entirety. 203 It 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 204 Under 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. 205 Moreover, 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. 206 In 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. 207 Furthermore, 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. 208 Moreover, 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. 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. da Silva Passos Schwarcz Półtorak Reine Pynnä Delivered in open court in Luxembourg on 19 November 2025. [Signatures] Table of contents * Language of the case: German.