The European Medicines Agency has responded to another request from European Ombudsman Emily O’Reilly who still has concerns relating to redacted clinical study reports (CSRs) on AbbVie’s blockbuster Humira and its Crohn’s disease indication.
The case began in April when Ms O’Reilly began to look at a settlement between the EMA and AbbVie after the latter ended court proceedings designed to stop the agency releasing certain CSRs on Humira (adalimumab). She has now written to the EMA, thanking it for some of the explanations it has given but she also has numerous other questions.
In a lengthy letter (see link below), Ms O’Reilly says that “from a close reading of the documents, that certain redactions may be justified to protect the personal data of patients”. Certain others, which mention the names of companies that provided services to AbbVie, or software it used “are not, in my view, problematic, as they may be considered to relate to the confidential business relationships of AbbVie”.
‘Doubts and concerns’
However, she goes on to say “I have doubts and concerns as regards other redactions”. Ms Reilly then lists 16 in-depth questions asking the EMA to justify the redactions on a range of issues in each CSR, such as protocol and statistical changes, sample size and dose selection. The Ombudsman has asked the EMA by January 31 next year.
The agency responded by saying “comments from the Ombudsman and other interested parties are a welcome addition to the ongoing debate on the concept of commercially confidential information”.
However it notes that while EU legislation “provides ample guidance on the protection of personal data, there is no agreed or binding definition of commercially confidential information. Based on experience and stakeholder feedback, the agency is continuously improving its understanding of what can and cannot be considered confidential”.
‘Overwhelming majority’ of data published
Citing its recently-adopted policy on the publication of CSRs, the EMA “clearly states that the overwhelming majority of data in clinical reports is not commercially confidential and can therefore be released to the public. In very few instances, some sections of the study reports may contain information that could be considered confidential”.
It adds that companies can suggest possible redactions but these will be accepted “only if the information is not already in the public domain and if companies are able to justify that disclosure of the information in question would undermine their competitive position”.
