European Medicines Agency agrees policy on publication of clinical trial data with more user-friendly amendment
EMA Management Board will formally adopt policy in coming weeks
The European Medicines Agency Management Board on 12 June agreed its policy on publication of clinical trial data, together with more user-friendly amendments proposed by EMA Executive Director Guido Rasi.
This will not only allow the Agency to publish clinical trial data 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 Board discussions, 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. It 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 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 this year. This showed broad support for the policy, but highlighted concerns over the proposed view-on-screen-only access.
EMA's policy is an important step forward towards achieving increased transparency in the regulation of medicines in Europe
The Agency says its policy is an important step forward towards achieving increased transparency in the regulation of medicines in Europe. It takes the regulator beyond its legal obligations and provides an unprecedented level of access to clinical trial data used as part of decision-making for new medicines.
The Management Board also adopted a revised process for assessing the eligibility of patients’ and healthcare professionals’ organisations to provide input to the Agency on general issues related to medicines. This process allows the Agency to identify the most appropriate organisations acting in the interests of European civil society. The eligibility criteria have been updated to align with increased transparency requirements, in particular on sources and level of funding and a code of conduct on their relationship with pharmaceutical industry.
The Board gave a positive assessment of the EMA’s operations in 2013, and of its management and internal control system. This analysis highlights, among other topics, the Agency’s initiatives towards stronger interaction with health technology assessment bodies to facilitate patient access to medicines and its new organisational structure designed better to support the scientific work of the EMA's committees, improve partner and stakeholder relations, and facilitate data-sharing among the European medicines regulatory network.