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EMA delays trial transparency – again

Published on 10/07/14 at 09:04am
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EMA headquarters

The European Medicines Agency has once again said that it is to delay the launch of its new clinical trial transparency policy – this time until October.

The European regulator says that the suspension is due to the need for “further discussion required on wording and practical arrangements”.

But this is not the first time the EMA has halted its plans, it was due to enact the new transparency policy from 1 January this year following a consultation period that lasted throughout much of 2013, but then admitted in November it would miss this deadline.

In April, the Agency then said it needed more time to speak with stakeholders over a second consultation on the plans to be held over the spring, adding that it also needed to sift through the ‘thousands of responses’ it has received.

A final agreement after these initial delays was meant to be made by June, but now the EMA’s management board has waited until July to say that is has postponed formal adoption of the policy until its meeting on 2 October.

The EMA says its board was unable to agree on the ‘final wording’ of the policy, meaning further clarifications will need to be discussed by board members. It has however, confirmed their ‘general support’ to the overall aims and objectives of the policy.

The discussions are focussing on the possible redaction of the clinical study reports to be published. If applied, these redactions (black lines stuck through text) will be based on the criteria identified by the Agency for those parts of clinical trial data that exceptionally contain commercially confidential information (CCI).

It will also aim to clarify how the concerned data-owners (i.e., pharma companies) will be consulted before publication of their clinical study reports, and user-friendly technical measures to make the data accessible under the new policy, including their terms of use.

The EMA’s executive director Guido Rasi has also suggested that new amendments should be added that would allow data to be downloaded, saved or printed for academic and non-commercial research purposes.

The main element behind the new policy means that CCI will for most pharma companies no longer remain a defence against the publication of data.

In the last 12 months the Agency explains that it “has attempted to strike a balance between proactive data disclosure, the absolute need to protect personal data and the concerns relating to the protection of commercially confidential information”.

Trying to juggle the need for greater disclosure whilst not revealing the patented secrets of the industry is the key battle for all stakeholders, and is the primary reason as to why there is still no agreement.

The need for public data

Pharma has been critical of the need for more data transparency, with the main European pharma lobby group EFPIA saying it would rather self-regulate than have external policies telling pharma how to publish and when.

But public opinion seems to be swinging towards an expectation of increasing transparency and openness coming not just from pharma – but also all corporate and governmental bodies in general.

The Agency management says it ‘remains committed’ to introducing greater transparency and will do this ‘as soon as possible’, despite the delays.

It will need to be done by 2016 as new rules from the European Commission, which were passed in April, will make transparency on new medicines for almost all pharma companies mandatory.

The EMA statement concludes: “The Agency management is conscious that any delay prevents citizens, and in particular academics and non-commercial researchers, from enjoying the benefits of proactive publication of clinical trial data for a further period.

“The Agency will continue to work with the management board and the European Commission ahead of the 2 October meeting to ensure that members receive the clarifications requested and to facilitate the adoption of the policy.”

Ben Adams

 

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