The European Medicines Agency announced a new policy on Thursday to start publishing clinical reports that are provided as part of regulatory filings. The agency said the change will apply to all applications for centralised marketing authorisation submitted as of January 1, adding that the reports will be released as soon as a decision on the application is made. EMA executive director Guido Rasi remarked that "the adoption of this policy sets a new standard for transparency in public health and pharmaceutical [R&D]."
According to the EMA, the policy will serve as a "complementary tool" ahead of the implementation of EU transparency rules for clinical trials that are not scheduled to come into effect before May 2016. The EMA expects the new policy will "increase trust in its regulatory work" by permitting the public "to better understand the agency's decision-making" during the review of drug applications. In addition to allowing researchers to re-assess data sets, the publication of clinical reports is also expected to help "avoid duplication of clinical trials, foster innovation and encourage development of new medicines," the EMA said.
However, the regulator stated the reports cannot be used for commercial purposes, noting that "in general" they do not contain information that is commercially sensitive. "Information that, in limited instances, may be considered commercially confidential will be redacted," the EMA said, adding "the decision on such redactions lies with the agency."
The regulator further indicated it will grant access to clinical reports submitted as of July 1, 2015, for applications seeking expanded product approval, once a decision has been rendered. Looking ahead, the agency said it also plans to make individual patient data available in future, adding that it will hold consultations with different groups in order "to address the various legal and technical issues linked with the access to patient data." The EMA said the new policy does not replace its existing rules on access to documents, which will be reviewed by June 2016.
A draft version of the updated policy released in June 2013 raised concerns from the pharmaceutical industry that the changes could undermine competition and potentially stifle investment in drug research in Europe. AbbVie sought to prevent the EMA from releasing its clinical trial data under a 2010 policy revision devised to grant "wider access than ever before" to documents submitted as part of regulatory filings. However, AbbVie withdrew the litigation earlier this year after the agency accepted a new set of redacted documents from the company.
Commenting on the new policy, Tracey Brown, managing director of Sense About Science, which has campaigned for greater clinical data transparency, said she was pleased the EMA had reversed a proposal that would have meant researchers could only see information from clinical trials on-screen in a sealed room. "However, it is still the case that trial sponsors (drug companies) can cut out any information they don't want others to see," Brown noted.
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