Why certain information of the clinical study report is redacted?

By William Chin, PhD, Scientific Coordinator, EUCRAF

On 10 February 215, the European Medicines Agency (EMA) has published a letter to the European Ombudsman’s questions related to the redaction of information in clinical study reports for the medicine Humira. The explanation provided by EMA is in response to the Ombudsman's letter dated 27 October 2014. In 2013, the EMA has received request for access to documents pertaining to Humira. This has prompted AbbVie to pursue a court case against EMA to prevent the release of clinical trial data on the basis that no documents from the dossier submitted by the marketing authorization holder could be disclosed to the public under Regulation (EC) No 1049/2001. However, Abbvie dropped the legal action against EMA after the Agency agreed a limited number of redactions of the documents.

The letter to the Ombudsman explained how EMA applied the rules on access to documents to this particular case. One of the highlights of the response is that 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. EMA further added that "such redaction could be acceptable if reference was made to the category of information protected by the relevant exception invoked". EMA said that by decribing at length the justification for the redaction of every single word would impair the use of resource at the Agency and could dramatically hinder the release of documents. There should be a reasonable balance between the level of details of such justification and the efficiency in disclosing documents, which is in line with Regulation (EC) No 1049/2001 and the new Clinical Trial Regulation, EMA explained.


1. EMA, News and Events, 10 February 2015, EMA explains its redaction rule