EMA explains its redaction rules, responding to Ombudsman questions
The European Medicines Agency has published a detailed response to the European Ombudsman’s questions related to the redaction of certain elements of clinical study reports for the medicine Humira (adalimumab).
In a letter dated October 27, 2014, the Ombudsman requested the EMA to explain why it had redacted certain information in response to an access to documents request that was received by the Agency in 2013. This particular access to documents request had led to a court case (T-44/13) against the Agency brought by US drugmaker AbbVie (NYSE: ABBV), the marketing authorization holder of Humira, which sought to prevent the Agency from releasing the information under its access to documents policy.
The case was ultimately withdrawn by AbbVie, after the EMA agreed a limited number of redactions of the documents in line with the Agency’s rules.
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