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EMA transparency agenda sees more delay

Published on 09/04/14 at 08:18am
The EMA's building in London

The European Medicines Agency is to further delay its policy over clinical trial transparency, saying it needs more time to speak with stakeholders with a second consultation.

This latest consultation is meant to “clarify and fine-tune specific aspects and achieve the broadest possible consensus and understanding of the [transparency] policy”, according to the EU regulator.

The discussions will focus on the presentation by the EMA of the principles set for the possible redaction of the clinical study reports to be published.

If applied, the 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).

Much of this relates to ensuring patient confidentially by removing names and other personal data, something that pharma has raised concerns about.

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 says it will launch a final round of ‘targeted consultations’ with key stakeholders on its draft policy to publish more clinical trial data ‘at the beginning of May’.

This it says will give key stakeholders and the Agency the opportunity to address any outstanding issues before the final policy is presented to the EMA’s management board for endorsement in June 2014.


The European regulator was meant to enact the new transparency policy from 1 January this year, but after its first consultation period, which lasted throughout much of 2013, it decided to delay this roll-out to sift through the thousands of responses it received.

The quintessential element of this policy will see the EMA no longer regard clinical trial data as CCI, therefore allowing it to publish pharma’s study information.

This has been met with much derision from pharma in Europe, which has favoured self-regulation when it comes to publication.

But what is happening at the EMA may now be a moot point given that just last week the European Parliament voted to remove CCI and allow greater clinical trial transparency for new medicines.

The new Clinical Trials Regulation must be ratified by all Member States, and is expected to become law by mid-2016.

The EMA’s clinical trial data policy runs in parallel with this Regulation, according to the Agency, although it is still unclear how the two policies will work in tandem.

Legal cases

In the same week that the Parliament voted for more data disclosure, a long-running legal tussle between the EMA and AbbVie, which focussed around the US firm being made to release data on its big-selling arthritis treatment Humira (adalimumab), was also put to an end when AbbVie agreed to share its information, but with some redactions.

The legal case between the EMA and InterMune, which is in the same vein trying to stop the regulator from publishing information about its lung disease drug Esbriet (pirfenidone), is however still ongoing.

The Agency concludes by saying that it “is committed to pursuing the objective of full transparency regarding clinical trial data” because it believes that the release of data contributes to “establishing trust and confidence in the system”.

Ben Adams

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