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EMA responds to redaction concerns

Published on 14/11/14 at 08:08am
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The EMA has published a response to European Ombudsman Emily O’Reilly’s questions about some of its trial data redactions.

O’Reilly’s concerns related to redactions made to data the European regulator released for AbbVie’s arthritis treatment Humira (adalimumab).

AbbVie tried to sue the EMA in 2013 to prevent it from releasing the data, but dropped the case after reaching a compromise in which the regulator would instead release redacted documents. O’Reilly became involved when she began looking at a settlement between the two.

The EMA said at the time: “The very limited redactions proposed by AbbVie were consistent with the Agency’s redaction practices and also had no significant impact on the readability of the reports. Therefore, a decision accepting that new set of documents was notified to the company.”

However, in October O’Reilly published a letter addressed to Guido Rasi, executive director of the EMA, saying that while some redactions were clearly needed to protect patients and business relations, in several other cases the Agency had failed to specify “in any detail, why that information has been redacted”.

She lists sixteen questions asking for justification for the redactions that she considers questionable, which cover areas ranging from protocol changes to dosage selection and sample size.

In a statement posted on its website, the EMA says: “Comments from the Ombudsman and other interested parties are a welcome addition to the ongoing debate on the concept of commercially confidential information.

“It is, however, important to stress that EMA is responsible for ruling on any redactions of documents to be published. The Agency always takes its decisions based on a careful assessment of the specific request and in accordance with existing laws and internal implementing rules.

“[Redaction suggestions] will be accepted by the Agency 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.”

The regulator adds that “the overwhelming majority of data in clinical reports is not commercially confidential and can therefore be released to the public”, but that “[Redactions allow the] EMA to give widest-possible access to data while protecting the privacy of individuals and justified economic interests”.

A barrier to transparency?

The EMA’s redactions policy has remained in place even during the regulator’s recent push for transparency – it has recently passed new rules that will soon mandate pharma companies to release more of their trial data.

By its own admission in its response to O’Reilly, however, the regulator says : “There is no agreed or binding definition of commercially confidential information,” before adding “based on experience and stakeholder feedback, the Agency is continuously improving its understanding of what can and cannot be considered confidential.”

Transparency advocate Ben Goldacre has criticised the use of redactions as continuing to be a barrier to true transparency – calling the EMA’s previous redaction performance ‘not encouraging’ and pointing out the Humira case in particular.

“It is hard to see how it is justifiable to hide protocol changes, in a trial from eight years ago, on over-riding grounds of commercial confidentiality,” he says.

Humira is the world’s biggest-selling drug, although it is set to lose its patents in 2016 and AbbVie has yet to find a comparable blockbuster to replace it.

O’Reilly has requested that the EMA’s full reply reach her by 31 January 2015. The Agency has says that this will ‘follow in due course’.

George Underwood


it turns out that it is not as important as I thought. Many things are going on in the world right now, really horrible and frightening things people need to know to create change. I do my assignment and like the fact that the newscasts focus on silly news like this, but no.

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