The EMA has announced a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of clinical trial data. The policy seeks to balance the commitment to provide the widest possible access to data with the need to protect personal data and legitimate commercial confidential information. The Agency has been releasing clinical trial reports on request once the decision-making phase of the marketing authorisation process has been completed since November 2010 as part of its access to documents policy. It is now moving towards proactive publication of clinical trial data and has published for consultation a draft policy on proactive publication of clinical trial data in June 2013. The consultation was open for 3 months during which the EMA has received over 1,000 comments. The policy was then discussed at the EMA’s Management Meeting in March 2014.
Now the final fine-tuning consultations will take place at the beginning of May 2014 and will focus on the principles for the possible pre-publication redaction of the clinical trial study reports in order to protect data containing commercially confidential information. Another objective is to clarify how the data owners will be consulted before publication of clinical study reports. The policy is expected to be presented to the EMA’s Management Board for endorsement in June 2014.
The clinical data policy is part of the EMA’s transparency initiative intended to encourage trust and confidence in the system. It runs parallel to other initiatives in the EU to increase transparency of clinical trials, in particular the new Clinical Trials Regulation which received a strong vote in favour in the European Parliament on 2 April 2014 and is expected to come into force in mid-2016.
At the same time, AbbVie has withdrawn both its court cases brought against the Agency concerning access to clinical trial data. The cases concern requests by third parties for access to AbbVie’s clinical trial reports submitted to the EMA. The EMA has initially refused access on the grounds that it would undermine AbbVie’s commercial interests. However, it decided to release the data following a complaint to the European Ombudsman who concluded that the reports did not contain commercially confidential information and recommended that the information be disclosed. AbbVie applied to the General Court to annul the Agency's decision to release the information. It also made an application for a preliminary injunction to prevent disclosure pending a final decision, which was granted in April 2013. Following the successful appeal to the CJEU by the Agency, the preliminary injunction was set aside and AbbVie has asked the EMA to consider a new set of redacted documents. The EMA considered that the very limited redactions proposed by AbbVie were consistent with the Agency’s redaction practices and had no significant impact on the readability of the reports. The EMA has therefore accepted the new documents.
Another court case brought by InterMune against the EMA challenging a decision to grant access to clinical study reports is still ongoing.