EU General Court: technical vaccine data does not have to be disclosed on request

The EU General Court delivered a significant judgment concerning access to documents held by the European Medicines Agency (EMA), this time relating to a conditionally authorised COVID-19 vaccine. This case (T-623/22) serves as an addition to the elaborate case law on the balance between transparency in health matters and the protection of companies’ commercial interests. On this (rare) occasion, the commercial interests of the conditional marketing authorisation (‘MA’) holder prevailed, although an appeal is currently pending (C-38/26 P).

Factual background

In December 2020, the European Commission adopted an implementing decision on the granting of a conditional MA to BioNTech for its Comirnaty – COVID-19 mRNA vaccine (nucleoside modified) 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.

A year later, a natural person sent the EMA an application for access to documents concerning part (a) of the first specific obligation referred to above. The EMA identified three relevant documents and, after consulting BioNTech, offered him access to a redacted version, prompting him to submit a confirmatory request for full disclosure.

After re-examining its initial decision, the EMA allowed broader disclosure of the documents while maintaining partial redactions to protect BioNTech’s commercial interests, leading the individual to bring an annulment action against this decision before the EU General Court.

The EMA properly applied the commercial interests exception

The main focus of this blog is the General Court’s reasoning on the nature of the redacted information. As outlined below, the Court agreed that the EMA was justified in withholding certain information to protect BioNTech’s commercial interests in accordance with the first indent of Article 4(2) of Regulation No 1049/2001 on access to documents:

•  After examining the unredacted documents, the Court found that the redacted information consisted of highly technical numerical test results and related parameters concerning the characterisation of the active substance and the Comirnaty product, derived from BioNTech’s know-how. It accepted the EMA’s view that disclosure could give competitors an advantage by allowing them to save scientific, human, and economic resources, and therefore concluded that the information was commercially sensitive and that there was a reasonably foreseeable, non-hypothetical risk to BioNTech’s commercial interests.
• The Court clarified that just because the redacted data were submitted to the EMA as part of a conditional marketing application, this does not automatically make them part of the public domain. Treating them as such would render the exceptions to public access in Regulation No 1049/2001 meaningless. Similarly, even though the data concern the vaccine’s quality, they remain confidential when they involve new technology and commercially sensitive information, as in this case.
• The Court further considered whether there was an overriding public interest that could justify disclosing the redacted information. It noted that anyone challenging a refusal must show that disclosure would specifically serve a public interest strong enough to outweigh the relevant commercial interests. While it is not necessary for an applicant to explain why they are requesting access, they must still demonstrate that disclosure would meaningfully advance that public interest. In this case, although patient information and vaccine safety are clearly public concerns, the applicant did not show how the EMA’s partial disclosure failed to address them. Most of the relevant information and conclusions had already been released, and the remaining redacted data were limited, technical, and primarily useful to BioNTech’s competitors.
• Finally, the Court held that the principle of transparency only overrides commercial interests where the circumstances make it particularly pressing. While the public clearly has an interest in understanding EMA decisions for vaccines, developed under the exceptional circumstances of the COVID-19 pandemic, this does not entitle general access to all detailed data submitted by the company. Moreover, general concerns about public health are not sufficient on their own to justify releasing the redacted information. In this case, the Court concluded that the applicant had not demonstrated that transparency created an overriding public interest capable of outweighing the reasons for withholding the data.

In the light of the above, the General Court dismissed the annulment action, thereby confirming the EMA’s decision and safeguarding the confidentiality of the relevant technical vaccine data.

Conclusion

In conclusion, the General Court’s ruling in Case T-623/22 confirms that highly technical vaccine data, even when submitted to the EMA as part of a conditional MA, can be withheld to protect a company’s commercial interests. Transparency is important, but it does not automatically override the need for confidentiality, particularly when the remaining information is limited, technical, and primarily of value to competitors rather than the general public.