The European Medicines Agency has attempted to defend its policy on the publication of clinical trial data from criticism that its planned proposals are nowhere near transparent enough.
The EMA is holding a board meeting on June 12 to consider its draft policy on the publication of data which it says “has been shaped by the many comments we have received during the consultation phase”. However the agency has been attacked from a number of sides, such as the German cost watchdog IQWiG, the AllTrials campaign, the BMJ, the Cochrane Collaboration and many others.
In response to calls for more transparency, the EMA said it makes intensely-detailed clinical study reports (CSRs) available to researchers but critics have expressed their horror over a move which will give access to ‘on-screen only’ viewing of redacted documents and researchers will also have to sign up to restrictive terms of use.
The EMA says it was faced with “an unprecedented level of response and range of divergent interests during its public consultation”. Some parties, presumably the pharmaceutical industry, argued that the policy would encourage unfair commercial use of data outside of the EU, disincentivise R&D in Europe and damage intellectual property.
On the other side, the EMA says, some saw the policy as limiting the ability of researchers and academics to carry out “meaningful re-analysis of data on medicines, as offering limited benefit for public health, even as restricting rights to access documents and going against the principles of transparency and openness”.
Strikingly, the agency argues that its draft policy is “a compromise approach“ that takes into account different stakeholders’ competing interests, in the absence of any specific current legal provision mandating the EMA to publish documents submitted by third parties. The agency claims that “if agreed, the policy will serve as a useful complementary tool ahead of the implementation of the new clinical trials regulation when it comes into force no sooner than May 2016”.
Guido Rasi, EMA executive director, said: “I remain open-minded and will explore with the board possible alternative approaches, especially more user-friendly ways of providing access to data and meeting the reasonable expectations of academics and researchers”.
AllTrials noted that AbbVie and InterMune, which started court action to prevent the EMA from releasing CSRs from trials on their drugs last year have both recently dropped their cases, a move which suggests that the EMA “made a back room deal with pharma over transparency”. The result of the board meeting will be eagerly awaited.
