EMA explains its redaction rules

10 Feabhra 2015

Agency responds to European Ombudsman

The European Medicines Agency (EMA) has published a Letter to European Ombudsman to the European Ombudsman's questions related to the redaction of certain elements of clinical study reports for the medicine Humira.

In a letter dated 27 October 2014, the Ombudsman requested 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 the marketing authorisation holder of Humira, who sought to prevent the Agency from releasing the information under its access to documents policy.

The case was ultimately withdrawn by the marketing authorisation holder after EMA agreed a limited number of redactions of the documents in line with the Agency's rules.

The Agency's letter to the Ombudsman confirms this by explaining how EMA applied the rules on access to documents to this particular case. This revolves around three main themes:

• EMA confirms its opinion that clinical reports are not confidential. However, some very limited information contained in a clinical report may be considered commercially confidential, e.g. when the information reveals as yet undisclosed commercial development plans, and in these cases may be redacted.
• The redaction of information contained in a clinical study report is a dynamic process that evolves over time. Information that may have been considered confidential at a certain point in time may no longer fall under this category at a later time, depending on the development of the medicine and the availability of public information on those plans.
• EMA applies its technical and scientific competence in the assessment of claims of confidentiality made by pharmaceutical companies and in the redaction of clinical study reports.

The annex to the letter provides detailed responses to each of the Ombudsman's questions, which can be found in the October 2014 letter of the Ombudsman.