EU Overhaul of Clinical Trials Directive Advances, Would Demand Full Data Transparency

| 30 May 2013

The European Parliament's (EP) Committee on the Environment, Public Health and Food Safety (ENVI) has endorsed and released a new draft rule regarding clinical trials for new medicines, saying the changes should result in "simpler, more uniform" rules and halt a five-year decline in clinical trials being conducted in the EU region.

Background

The rule was first called for in July 2012 by then-health commissioner John Dalli, who pointed to the 25% decline in EU clinical trials. The reason, he said, was mostly attributable to the difficulties associated with conducting trials in the EU under the Clinical Trials Directive (2001/20/EC), which Dalli said was "arguably the most heavily criticized piece of EU legislation in the area of pharmaceuticals."

Dalli said an ideal proposal would include faster assessment procedures, reporting mechanisms, timelines for approval and trial extensions, mechanisms for all of which were included in a framework proposal he put forth in July 2012.

[For more, please read our 18 July 2012 story, "New EU Clinical Trials Proposal to Ease Pharmaceutical Industry's Concerns."]

Then, in February 2013, ENVI announced the release of an amended version of Dalli's original proposal, which called for full publication of all clinical trials data. "Clinical trial data should not be considered commercially confidential once a marketing authorisation has been obtained," legislators wrote. "For the sake of transparency, once a clinical trial has led to marketing authorisation, data generated during the clinical trial should be fully accessible."

Legislators also proposed requiring companies to generate standardized clinical study reports (CSRs) using International Conference on Harmonisation (ICH) guidelines (ICH E3). "The introduction of the clinical study report is in the interest of increased transparency," legislators explained. "These are internationally accepted guidelines on preparing a full description of a clinical trial and its results.  This will help sponsors provide harmonised information, and increase transparency by greatly increasing the amount of data available to the public and independent researchers."

[For more, please read our 5 February 2013 story, "Amended EU Clinical Trials Proposal Calls for Full Publication of Clinical Trials Data."]

New Developments

Now ENVI legislators have announced the release of the most recent iteration of the proposal, which have now won the endorsement of the Public Health Committee. The revisions are meant to replace the Clinical Trials Directive, the legislators wrote.

"The aims of the Directive were admirable, but many of the requirements were geared towards trials sponsored by pharmaceutical companies, while those with non-commercial sponsors were overlooked, and true harmonisation was never achieved," said Glenis Willmott (UK), a member of parliament. "Getting better legislation in place soon is crucial to enable and encourage life-saving research."

The transparency measures appear to have made their way into the most recent draft, with legislators explaining that "detailed summaries" must be made available in an accessible EU database prior to a drug's approval, and full Clinical Study Reports (CSRs) made available after market authorization is received. Fines would be assessed on companies that fail to comply.

In other areas, legislators said the revisions would reduce the burdens for providing compensation for damages, which would instead be covered by the national healthcare systems of each respective country. For other trials, countries could set up indemnification systems to reduce the insurance costs for the trial sponsor. The overall intent is to decrease the costs of many trials.

The changes, which are visible here, will still need to be approved by the full European Parliament, which would occur at its October 2013 Plenary session, and then by the Council of the European Union.

CTD Legislative File