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European Medicines Agency, Seen as Undermining Transparency, Applauds New Regulations

By Clinical Informatics News Staff

May 28, 2014 | Yesterday, the Official Journal of the European Union published legislation passed last month that will require open publication of all clinical trial results, to take effect in 2016. The event was greeted by a press release this morning from the European Medicines Agency (EMA), celebrating the move. “This is directly in line with the Agency's commitment to increased transparency of these data, through its draft policy on proactive publication and access to clinical trial data,” wrote the EMA in its statement.

The EMA will have broad responsibilities in overseeing the new clinical trial regulations, including building the IT architecture that allows the public to review trial data. However, the agency has recently come under fire for apparently backtracking on transparency commitments. A draft policy by the EMA dated May 5, outlining how the agency will make clinical trial data available in the period before the new regulations come into force, contained at least three provisions that alarm transparency advocates. One measure would require anyone accessing clinical study reports to agree that the data contained in these reports legally belongs to the company that submitted them. A second measure would prohibit users from viewing data anywhere but in the portal provided by the EMA. By preventing researchers from downloading, printing, reformatting, or transferring data, this provision would make it prohibitively difficult to analyze clinical trial reports for retroactive studies. Finally, the draft policy allows some leeway for companies to redact data they see as competitive.

Critics of the draft policy include the European Ombudsman, Emily O'Reilly, who is responsible for policing agencies of the European Union for incidents of maladministration. O'Reilly wrote a letter to the EMA this month insisting on greater protections for public access to clinical trial data; she has given the agency until this Saturday to respond.

This morning's press release addresses complaints about the draft policy, but does not give up any ground. “In drafting its policy, the Agency has carried out a broad public consultation, taking stock of the diverse views that were expressed,” the EMA writes. “In the current absence of a specific legal framework for the proactive release of clinical trial data as soon as the authorisation procedure on a new medicine has been finalised, the challenge in this exercise was to find a balance between the often competing views that would allow the Agency to move forward with its policy.”

If the EMA is not seen as a robust defender of transparency, its authority to oversee the new clinical trial regulations, passed by a large majority in the European Parliament, will be tarnished.


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