EU Ombudsman Says EMA Didn’t Violate Transparency Policy

The European Medicines Agency’s decision to redact certain personal and commercial information from clinical study reports before releasing them to a private citizen did not violate EU transparency policy, the European ombudsman says.

The case stems from a June 2015 complaint by a German citizen who had requested reports relating to a vaccine for hepatitis A and B. The EMA granted access to the reports, but blanked out part of the documents to protect personal data and commercial interests. The complainant accused the agency of blanking out entire pages of the documents.

The ombudsman’s office reviewed the matter and determined that the EMA acted appropriately in withholding personal data such as the names and other details of authors and co-authors of the reports.

However, Ombudsman Emily O’Reilly says the agency’s redaction of patients’ reference numbers wasn’t necessary, since this information wouldn’t allow the complainant to identify the patient.

O’Reilly also says it’s unclear that the EMA’s decision to redact portions of journal articles and studies was necessary to protect commercial interests. The agency failed to properly justify how disclosing this information would have infringed a copyright, but because the publications are easily accessible online, there’s no need to investigate further, she says.

Earlier this year, the EMA defended its decision to redact clinical study reports for AbbVie’s Crohn’s disease drug Humira, telling the ombudsman it was justified in blanking out information on undisclosed commercial development plans. The ombudsman has not issued a decision in that case.

Read the decision here: www.fdanews.com/10-15-Ombudsman-Decision.pdf. — Jonathon Shacat