More broadly, the agency is still grappling with how much information should be publically released when clinical study reports are unveiled. Earlier this summer the EMA went back and forth over that question as it prepares to release more CSRs under its new transparency policy.
“A detailed reply to the European Ombudsman’s queries shall follow in due course,” the EMA said in a statement, noting that it redacts any data “that might compromise personal data protection or be considered commercially confidential. This allows EMA to give widest-possible access to data while protecting the privacy of individuals and justified economic interests.”
Ombudsman’s Letter
But O’Reilly in her letter lays out more than 20 instances where the EMA may have redacted information that was unrelated to personal data protection or commercially confidential information.
“It is obvious, from a close reading of the documents, that certain redactions may be justified to protect the personal data of patients,” or that relate to the confidential business relationships of AbbVie, O’Reilly writes. “However, I have doubts and concerns as regards other redactions”
For instance, with regard to the redaction of protocol changes, the Ombudsman “has carefully reviewed the redacted text. She finds no obvious reason why the release of the redacted text relating to protocol changes would undermine a legitimate commercial interest of AbbVie.”
And she further questions if there “is always an overriding public interest in the disclosure of the information on statistical plans used and the changes thereto?”
In addition, O’Reilly takes issue with what the EMA considers “novel,” and in particular one instance where the text redacted “would appear to have important clinical value. Can EMA explain why this text is redacted as it does not obviously relate to an on-going development or an unexploited sub-indication?”