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Document 62016TJ0875

    Judgment of the General Court (Eighth Chamber) of 5 December 2018.
    Falcon Technologies International LLC v European Commission.
    Access to documents — Regulation (EC) No 1049/2001 — Assessment report of a notified body within the meaning of the legislation on EC declarations of conformity of medical devices — Refusal of access — Exception relating to protection of commercial interests — Obligation to carry out a specific and individual examination — Overriding public interest — Refusal of partial access.
    Case T-875/16.

    Court reports – general

    Judgment of the General Court (Eighth Chamber) of 5 December 2018 –
    Falcon Technologies International v Commission

    (Case T‑875/16)

    (Access to documents — Regulation (EC) No 1049/2001 — Assessment report of a notified body within the meaning of the legislation on EC declarations of conformity of medical devices — Refusal of access — Exception relating to protection of commercial interests — Obligation to carry out a specific and individual examination — Overriding public interest — Refusal of partial access)

    1. 

    Actions for annulment — Natural or legal persons — Interest in bringing proceedings — Action against a decision by an institution refusing access to documents — Admissibility

    (Art. 263, fourth para. TFEU; European Parliament and Council Regulation No 1049/2001, Art. 6(1))

    (see paras 28, 29)

    2. 

    EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Strict interpretation and application — Obligation to make a specific and individual examination for documents covered by an exception — Scope

    (European Parliament and Council Regulation No 1049/2001, Recital 11 and Art. 4)

    (see paras 39, 40, 58-62)

    3. 

    EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of the commercial interests of a given person — Scope — Assessment report of a notified body within the meaning of the legislation on EC declarations of conformity of medical devices — Possible damage to the notified body’s reputation on account of the details, in the report, regarding the analysis of any non-compliance by the body with the applicable legislation — Included

    (European Parliament and Council Regulation No 1049/2001, Art. 4(2), first indent; Commission Regulation No 920/2013)

    (see paras 42, 43, 47-54)

    4. 

    EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of commercial interests — Refusal to grant access — Obligation to state reasons — Scope

    (European Parliament and Council Regulation No 1049/2001, Art. 4(2), first indent)

    (see paras 68, 69)

    5. 

    EU institutions — Right of public access to documents — Regulation No 1049/2001 — Documents originating from the institutions held by national authorities — Applicability of national rules to requests for access

    (Art. 4(3) TEU; European Parliament and Council Regulation No 1049/2001, Recital 15 and Art. 5)

    (see para. 76)

    6. 

    EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Protection of commercial interests — Overriding public interest justifying the disclosure of documents — Concept — Burden of proof

    (European Parliament and Council Regulation No 1049/2001, Art. 4(2))

    (see paras 84, 85)

    7. 

    EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the right of access to documents — Overriding public interest justifying the disclosure of documents — Concept — Subjective interest of the person concerned in defending himself — Not included

    (European Parliament and Council Regulation No 1049/2001, Art. 4(2))

    (see paras 86-89)

    8. 

    EU institutions — Right of public access to documents — Regulation No 1049/2001 — Exceptions to the principle of access to documents — Obligation to grant partial access to those parts of the document not covered by exceptions

    (European Parliament and Council Regulation No 1049/2001, Art. 4(6))

    (see paras 96, 97)

    9. 

    EU institutions — Right of public access to documents — Regulation No 1049/2001 — Obligation to demonstrate the usefulness of the document to the applicant — Absence

    (European Parliament and Council Regulation No 1049/2001, Art. 4(6))

    (see paras 98, 102)

    Re:

    Application based on Article 263 TFEU seeking annulment of Commission Decision C(2016) 6722 final of 14 October 2016 refusing to grant the applicant access to the document (DG (Santé) 2015-7552.

    Operative part

    The Court:

    1. 

    Annuls Commission Decision C(2016) 6722 final of 14 October 2016, in so far as it refused partial access to the document DG (Santé) 2015-7552;

    2. 

    Dismisses the action as to the remainder;

    3. 

    Orders Falcon Technologies International LLC and the European Commission each to bear their own costs.

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