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Research Letter |

Transparency Interrupted:  The Curtailment of the European Medicines Agency’s Policy on Access to Documents

Peter Doshi, PhD1
[+] Author Affiliations
1Johns Hopkins University School of Medicine, Baltimore, Maryland
JAMA Intern Med. 2013;173(21):2009-2011. doi:10.1001/jamainternmed.2013.9989.
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A colleague and I recently reported on the first 2 years of the European Medicines Agency’s (EMA’s) November 2010 freedom of information policy on access to documents.1 The policy made a wide range of regulatory documents potentially accessible to anyone who asked for them, including clinical study reports. As of November 19, 2012, the EMA had released approximately 1.66 million pages of clinical trial data and other documents in response to 457 requests.1

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Figure.
Requests for Documents Handled Under the European Medicines Agency’s Policy Between November 30, 2010, and June 4, 2013

Requests from 1 individual for more than 1 product are counted as separate requests. I am responsible for 17 of the 33 requests in the academic/research institute category in the first quarter (Q) of 2013. The first quarter of 2010 and the second quarter of 2013 are not full (3 month) quarters.

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