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)
some further information… (1 Boring Old Man)