E-DRUG: HAI Europe urges EMA not to backtrack on commitments to clinical trial data transparency
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The European Ombudsman has publicly expressed her concerns about an apparent “significant change of policy” by the European Medicines Agency (EMA) regarding clinical trial data transparency. In a letter to the EMA on 13 May, 2014, and a subsequent press release on 16 May, the Ombudsman refers to draft documents produced by the EMA that indicate a turn in the Agency’s long-held commitment to the proactive publication of clinical trial data.
The documents in question refer to the ‘Terms of Use’ and ‘Redaction Principles’ that will shape the EMA’s future policy on proactive publication of clinical trial data if endorsed by its Management Board on 12 June, 2014. In particular, the Ombudsman is concerned about the EMA’s intention to “limit access to clinical trial data by imposing strict confidentiality requirements and by allowing data only to be seen on screen using an interface provided by the EMA, as well as imposing wide restrictions on the use of such data."
Health Action International (HAI) Europe is extremely concerned that the EMA may be abandoning its commitment to grant public access to clinical trial data, which is greatly needed. In our 22 May statement, HAI Europe urged the EMA to consider clinical trial data a public good; allow users to download, save, edit, print, distribute and transfer the information provided by the database; and provide true public access to the electronic EU database, as required by the clinical trials regulation.
In addition, given our concern about the impact that the proposed ‘Terms of Use’ and ‘Redaction Principles’ will have on the EMA’s current policy on access to documents, through which data is disclosed on request, we have called on the EMA to continue providing the same level of access, and the same level of unredacted information, through its policy on access to requested documents; refrain from requiring users to acknowledge that the information is protected by copyright and proprietary rights; and publish the outcome of the out-of-court settlement with the pharmaceutical company, AbbVie, regarding the disclosure of clinical trial data of one of its medicines.
Our full statement is available on our website: http://bit.ly/1i7S7io.
For more information, please contact HAI Europe policy advisor, Ancel.la Santos Quintano, at ancel.la@haieurope.org.
Bobbi Klettke <bobbi@haiglobal.org>