European Medicines Agency - - European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendments

" ... The European Medicines Agency Management Board on 12 June 2014 agreed the policy on publication of clinical trial data, together with more user-friendly amendments proposed by EMA Executive Director Guido Rasi, that 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. In light of discussions at the Board, the wording of the policy, including practical arrangements for academic and non-commercial research users, will now be finalised with a view to its adoption by the Board through written procedure by mid-July 2014, and will be effective from 1 October 2014. Importantly, the Agency will ensure that the policy will not prejudice citizens’ rights under existing access to documents legislation and the new clinical trials regulation. Since embarking on its plans for the proactive publication of clinical trial data, the Agency has aimed to achieve the broadest possible consensus among its stakeholders and their often competing views and interests. After an extensive consultation phase that took place between June and September 2013, the Agency carried out a second round of targeted consultation in May 2014 that showed broad support for the policy, but highlighted concerns over the proposed view-on-screen-only access. The Agency’s policy is an important step forward towards achieving increased transparency in the regulation of medicines in Europe. It takes the Agency beyond its legal obligations and provides an unprecedented level of access to clinical trial data that are used as part of decision-making for new medicines ..."