European Medicine Agency's Open Access to Documents Tested

Ricki Lewis, PhD

December 19, 2012

The first 2 years of a program allowing open access to regulatory documents of the European Medicines Agency (EMA) are evaluated in a research letter published online December 19 in the Archives of Internal Medicine.

Beginning November 30, 2010, the EMA has made available any regulatory documents to anyone who asks. The documents are downloadable as PDFs, without charge. This practice is in sharp contrast to the policy of the US Food and Drug Administration, which does not allow public access to industry-sponsored clinical trial information, even under the Freedom of Information Act.

To evaluate the ease of accessing the documents as well as to investigate who is using the access and how, Peter Doshi, PhD, from Johns Hopkins University School of Medicine, Baltimore, Maryland, and Tom Jefferson, MD, from the Cochrane Collaboration, Rome, Italy, obtained an annotated list of all 457 document requests received since the program began. To test the system directly, the researchers requested information on clinical trials of Roche's neuraminidase inhibitor oseltamivir phosphate (Tamiflu), retrieving 25,000 pages of unredacted information.

Most of the 457 requests, the researchers discovered, came from the pharmaceutical industry (491,989 pages), the media, and legal affiliates. Assessment reports, dossiers, and clinical study reports were the most frequently requested types of documents, and more than 30 types of regulatory or marketing documents were requested overall. "Altogether, the EMA released 1 656 285 pages in the first 2 years of the program," the researchers write.

The researchers also note that healthcare professionals and the general public did not seem to be taking advantage of the opportunity to obtain regulatory documents, perhaps because they are unaware of the new policy. About a quarter of the requests did not result in access to information, either because the EMA did not have the information or the client did not respond in a timely manner to an agency request for clarification.

Limitations of the study include the unknown number of pages that were redacted; the misclassification of requests, such as "industry" presented as "legal"; and the inability to evaluate the long-term effects of the new policy.

The EMA plans to begin "proactive" publication of clinical trial data starting January 1, 2014, after discussion throughout the coming year of what exactly the initiative covers. Five advisory groups will address patient confidentiality, data formats, rules for downloading documents, analytical techniques, and legal questions, Robert Steinbrook, MD, from the Yale School of Medicine, New Haven, Connecticut, writes in an accompanying commentary.

Dr. Steinbrook applauds the new openness. "If the EMA fulfills its promises, a new era of clinical trial data as a public good will begin," he writes, adding that all data will be available, even those from trials that industry sponsors.

In addition, in a related policy change that will take effect in the new year, the EMA will request submission of raw data from studies that are incomplete or have negative results.

Dr. Doshi received payment to lecture about oseltamivir. Dr. Jefferson has provided expert testimony on oseltamivir and influenza vaccine. Commentator Dr. Steinbrook cited no conflicts of interest.

Arch Intern Med. Published online December 19, 2012. Article full text, Commentary full text