EMA Responds to Rationale for Redacting Clinical Information on AbbVie's Humira

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 02-13-2015 13:28


The European Medicines Agency (EMA) 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), AbbVie's drug for treatment of inflammatory diseases, including rheumatoid arthritis, plaque psoriasis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis. The European Ombudsman investigates complaints about maladministration in the institutions and bodies of the European Union.

In a letter dated October 27, 2014, the Ombudsman requested that the EMA 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 by AbbVie against the agency brought by the marketing authorization holder of Humira, AbbVie, who sought to prevent the agency from releasing the information under its access to documents policy.

The case was ultimately withdrawn by the marketing authorization holder (AbbVie) after the EMA agreed a limited number of redactions of the documents in line with the agency’s rules. EMA said that its letter to the ombudsman confirms this by explaining how the 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.

Source: European Medicines Agency


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