EU Ombudsman raises issues with some of EMA’s redactions of AbbVie data

By Zachary Brennan

- Last updated on GMT

EU Ombudsman raises issue with some of EMA’s redactions of AbbVie data

Related tags Protection

The EMA said Wednesday it will formally respond to a letter sent by EU ombudsman Emily O'Reilly to the agency in which she took particular issue with some redacted information from AbbVie’s CSRs (clinical study reports).

More broadly, the agency is still grappling with how much information should be publically released when clinical study reports are unveiled. Earlier this summer the EMA went back and forth​ over that question as it prepares to release more CSRs under its new transparency policy.

A detailed reply to the European Ombudsman’s queries shall follow in due course​,” the EMA said in a statement, noting that it redacts any data “that might compromise personal data protection or be considered commercially confidential. This allows EMA to give widest-possible access to data while protecting the privacy of individuals and justified economic interests​.”

Ombudsman’s Letter

But O’Reilly in her letter lays out more than 20 instances where the EMA may have redacted information that was unrelated to personal data protection or commercially confidential information.

It is obvious, from a close reading of the documents, that certain redactions may be justified to protect the personal data of patients​,” or that relate to the confidential business relationships of AbbVie, O’Reilly writes. “However, I have doubts and concerns as regards other redactions​”

For instance, with regard to the redaction of protocol changes, the Ombudsman “has carefully reviewed the redacted text. She finds no obvious reason why the release of the redacted text relating to protocol changes would undermine a legitimate commercial interest of AbbVie​.”

And she further questions if there “is always an overriding public interest in the disclosure of the information on statistical plans used and the changes thereto​?”

In addition, O’Reilly takes issue with what the EMA considers “novel​,” and in particular one instance where the text redacted “would appear to have important clinical value. Can EMA explain why this text is redacted as it does not obviously relate to an on-going development or an unexploited sub-indication​?”  

Related news

Show more

Related products

show more

Using Define-XML to build more efficient studies

Using Define-XML to build more efficient studies

Content provided by Formedix | 14-Nov-2023 | White Paper

It is commonly thought that Define-XML is simply a dataset descriptor: a way to document what datasets look like, including the names and labels of datasets...

Overcoming rapid growth challenges with process liquid preparation

Overcoming rapid growth challenges with process liquid preparation

Content provided by Thermo Fisher Scientific - Process Liquid Preparation Services | 01-Nov-2023 | Case Study

A growing contract development manufacturing organization (CDMO) was challenged with the need to quickly expand their process liquid and buffer preparation...

Why should you use clinical trial technology?

Why should you use clinical trial technology?

Content provided by Formedix | 01-Nov-2023 | White Paper

New, innovative clinical trial technology is helping to revolutionize the research landscape. COVID-19 demonstrated that clinical trials can be run much...

Related suppliers

Follow us