Life Science Compliance Update

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October 13, 2014

Clinical Trial Transparency: Starting Jan. 1, 2015, European Medicines Agency Will Publish Clinical Reports For New Drugs; Individual Patient Data Next

Clincal Trail Transparency 2

On October 2, 2014, the European Medicines Agency (EMA) unanimously voted to publish the clinical reports “that underpin the decision-making on medicines.” EMA will publish data submitted as part of marketing applications starting January 1, 2015. Beginning July 1, 2015, the agency will provide access to reports relating to applications for line extensions of indications for existing medicines. The policy does not apply retroactively, so EMA will only publish new data.  

EMA is the “first entity in the world” to introduce such rules, EMA Executive Director Guido Rasi noted. “This unprecedented level of access to clinical reports will benefit patients, healthcare professionals, academia and industry.”

According to EMA’s press statement, “the publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines.”  

Under the policy (available here), users who want general information about the data can search and browse on-screen after a simple registration process. Users who want the information for academic and non-commercial research purposes will need to provide more detailed information to the agency, including their affiliations and positions within their organisations. Any information that is considered "commercially confidential" will be redacted from the documents.

EMA notes that the data “will only start to become accessible once the final decision on a given procedure has been reached by the European Commission, which implies a timeframe of about 18 months.”

Further down the line, EMA will consult with various stakeholders to “endeavor to find the most appropriate way to make individual patient data available, in compliance with privacy and data protection laws.”

Controversy

The AllTrials campaign, comprised of the BMJ, the Cochrane Collaboration, and others, has been leading the charge for more clinical transparency. Earlier this year, they criticized EMA’s trial policy because the agency was only going to allow users to view trial data in an on-screen-only option. We wrote about that controversy earlier this year.

In the latest policy, EMA removed the on-screen-only restriction and adopted a more “user-friendly” approach which will allow users to download the information. “Now, the public can either browse or search the data on screen, or download, print and save the information,” EMA states.

While the searchability of the data seemed like the big issue a few months ago, EMA has fronted additional criticism. In addition to the push for transparency, the agency must reconcile pharmaceutical companies' rights to commercially confidential information (CCI).  

According to EMA's statement, “[t]he reports cannot be used for commercial purposes...Information that, in limited instances, may be considered commercially confidential will be redacted. The redaction will be made in accordance with principles outlined in the policy’s annexes. The decision on such redactions lies with the Agency.” Many argue that the definition of CCI is very unclear. 

EMA stresses how infrequently a CCI determination will actually limit what users will be able to see. In their policy, EMA states that certain aspects of reports "MAY contain CCI and, therefore, MAY be redacted. It should be noted that NOT ALL the information in the sections...will be redacted but only the SUBSET of the text considered being CCI" (capitalization included in the report).  View the appendix describing what EMA designates commercially confidential information on page 8 of the document

AllTrials, however, believes this gives too much power to the companies. The policy puts primary responsibility for redacting information into the hands of companies, AllTrials states, meaning they get to suggest which information submitted to the EMA should be kept hidden. Furthermore, the campaign notes that the "Terms of Use" that companies and independent researchers must sign allows trial sponsors to take direct legal action against researchers for possible violation of the Terms. They are concerned that trial sponsors can sue independent researchers, which they argue "puts a chill on independent research.” Outsourcing Pharma notes this may mean higher legal costs for contract research organizations (CROs).

The Agency is also involved in a separate process to make summaries of the results of clinical trials publicly available through the EU Clinical Trials Register.

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