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EMA told to clarify redactions

The European ombudsman has asked the European Medicines Agency to give its rationale for redactions that it made in the published versions of three clinical trials reports.

The European ombudsman, Emily O’Reilly, sent a second letter to the EMA on 17 November, saying that although the redaction of documents to protect personal data is permitted, the agency has hidden data related to the design of three clinical trials and the patients’ outcomes. The agency has failed so far to explain the reasons for those changes, O’Reilly added.

The ombudsman wrote to the EMA for the first time in May, expressing her concerns over the rewriting by the agency of three clinical trial reports in order to purportedly protect the commercial interests of the pharmaceutical company involved. On 12 November, the EMA said that it is still working to implement its data publication policy and trying to come up with a definitive definition of commercially confidential information.

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