Europe Announces Policy on Medical Trial Data Access Amidst Criticism

Rob Wipond
3
47

The European Medicines Agency has announced a new policy that it says will open public access to pharmaceutical companies’ medical trial data. The new agreement, an Agency press release states, “will not only allow the Agency to proactively publish clinical trial data that are submitted as part of marketing authorisation applications, but also give the possibility to download, save and print the trial data for academic and non-commercial research purposes.” However, experts quoted in the British Medical Journal describe the new policy differently.

The British Medical Journal reports that many researchers regard the new European Medicines Agency policy as “overly restrictive” and overly in line with what the pharmaceutical industry had lobbied for. BMJ Associate Editor Peter Doshi quotes University of Toronto law professor Trudo Lemmens saying that the European Medicines Agency “seems to have returned very much to the former approach of giving companies a lot of leeway in deciding what they consider to be confidential.” Alltrials.net applauds that at least the policy, in response to public criticisms, will allow researchers “to download, save and print clinical study reports.”

European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments (Press release, European Medicines Agency)

EMA policy on transparency is “strikingly” similar to deal struck with drug company, say experts (British Medical Journal News, BMJ 2014;348:g3852)

EMA’s double U-turn on its peeping tom policy for data release? (Tom Jefferson and Peter Doshi, BMJ Group Blogs)

EMA has reversed its on-screen restrictions following researcher and citizen protest (Alltrials.net)

See also:

some further information… (1 Boring Old Man)

 

 

 

3 COMMENTS

  1. Btw, what is their justification against having to register every single clinical trial prior to conducting it, together with ethical committee clearance and then publishing all results including raw data (except for personal data of patients to avoid identification)? There is no logical reason for that and it’s the right of public to know it – not only doctors or researches. What is going on with drug approval process is beyond the pale shameful.

LEAVE A REPLY