The General Secretariat of the Council has transmitted to delegations a confirmatory application (No 38/c/01/26, registered 30 June 2026) challenging redactions made to three Council documents related to the Critical Medicines Act proposal (COM(2025)102). The applicant contests the legal basis and procedural handling of the redactions, requesting either full access or a passage-by-passage justification.
The initial access request, submitted on 9 May 2026 and registered on 11 May 2026, sought all Council documents concerning the Critical Medicines Act from 11 March 2025 to the present. In its reply of 25 June 2026, the Council identified 22 documents and provided access to most, but redacted "elements outside the scope" in three "Flash from the Presidency" notes: WK 4405/2025 INIT, WK 4405/2025 REV 1, and WK 14489/2025 REV 1.
The applicant argues that the redactions lack a document-specific justification under Article 4 of Regulation (EC) No 1049/2001 on public access to documents. The applicant further contends that the Council did not invite clarification under Article 6(2) of the regulation before applying the redactions, which would have allowed the applicant to narrow or refine the request. The confirmatory application requests either full disclosure of the three documents or a reasoned explanation for each redacted passage.
The Council must now reconsider its initial decision and either grant full access or provide detailed justifications for each redaction, citing the specific exception under Article 4. The outcome will test the application of transparency rules to preparatory documents in the legislative process.
The case directly affects transparency advocates and civil society groups seeking to monitor EU legislative processes. For the Council, a ruling against its redactions could set a precedent requiring more granular justifications for withholding information in future legislative files. The pharmaceutical industry and member states involved in the Critical Medicines Act may face increased scrutiny of their negotiating positions if documents become more accessible. The European Ombudsman or the Court of Justice of the EU could become involved if the applicant pursues further remedies.