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Summary of the decision in case 124/2018/NF on the European Commission’s refusal to give public access to documents concerning the EU funded ‘TETRA’ project on autologous stem cell seeded tissue engineered trachea

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  • Case: 124/2018/NF
    Opened on 18 Jan 2018 - Decision on 14 Mar 2018
  • Institution(s) concerned: European Commission

The case concerned the refusal by the European Commission to grant public access to documents on the status of an EU-funded clinical research project called ‘TETRA’. The aim of TETRA is to conduct a clinical trial on an innovative approach to tracheal replacement.

The requested documents contain information on the preparatory phase of the clinical trial. The Commission refused to disclose the documents arguing that doing so would undermine the commercial interests of the TETRA project participants and the privacy and integrity of some TETRA participants and individuals external to the project. The complainant contested the Commission’s decision against the background of a research fraud and misconduct scandal that had happened in a different research project in the field of tracheal implants.

The Ombudsman, having reviewed the documents and met with the Commission, found that there was no maladministration by the Commission. Given that the TETRA trial has not yet started, and is not imminent, and that the content of the status reports would not, if released, address any public health concerns or generate public benefit, the Ombudsman is of the view that there is no overriding public interest in disclosure of the TETRA status reports.