by ANCEL.LA SANTOS QUINTANO The European Medicines Agency (EMA) Management Board is expected to vote tomorrow on a new policy on clinical trial data transparency.
Previously, the EMA appeared committed to passing a policy that would grant full public access to clinical trial data—a move that is critically important for protecting public health. Recently, however, the Agency has shown signs that it may be abandoning its commitment. Health Action International (HAI) Europe and numerous other stakeholders, including the European Ombudsman, have expressed concern about this shift in policy.
Earlier today, HAI Europe sent the following email to members of the EMA Management Board, urging them to ensure that the EMA honours its previous commitments to clinical trial data transparency. ______________________________________________
Dear Member of the Management Board,
On Thursday, 12th of June, the European Medicines Agency (EMA) Management Board will be, in principle, voting on a new clinical trial transparency policy.
Since the implementation of its current policy on access to documents in 2010, the EMA has disclosed around 2 million pages of clinical trial data in response to safety-related requests, and therefore contributing to the unlocking of secret information that is crucial to public health. In parallel, the Agency has been working towards the proactive publication of clinical trial data with the aim to further strengthen transparency. In fact, the initial proposal for a policy on ‘Publication and access to clinical trial data’, published last year, deemed that clinical study reports should not be considered, in general, as commercially confidential information and should be proactively published.
In spite of these positive developments, however, the EMA is now backtracking on its long-held commitments to data transparency (1). Indeed, the policy documents that will be presented tomorrow to the Management Board for endorsement show a clear shift of policy, which raises serious concerns.
Second, as widely expressed by those in academia, the ‘view on screen only’ mode of clinical study reports makes the re-assessment of data a completely futile exercise—one that may even inadvertently lead to increased errors in the interpretation of data. Clearly, users should be able to save, download, print, copy and share these documents, which provide the most comprehensive information on each trial and amount to hundreds of pages.
Third, contrary to the European Ombudsman’s recommendation (3) and to the spirit of the newly adopted Clinical Trials Regulation (4) , the EMA proposes in its ‘Redaction principles’ document to classify key sections of clinical study reports as likely to be commercially confidential information, inviting companies to redact data up front. According to the EMA’s last proposal, companies would be submitting two types of clinical study reports; one for marketing authorisation and another for publication. Clearly, this process puts companies in the driver’s seat regarding redaction. Even worse, the general public would never get to know the extent of data that has been redacted.
In view of tomorrow’s vote, Health Action International Europe urges the members of the Management Board to reject the above-mentioned provisions and to revise the policy, in order for it to reflect the EMA’s previous commitments to data transparency. Most definitely, taking into account the ongoing investigation by the European Ombudsman, this decision should be, at a minimum, postponed.