Background to clinical data publication policy
The European Medicines Agency developed its policy on the publication of clinical data for human medicines, taking account of the views and concerns of a broad range of stakeholders and European bodies. The policy complements other policies and mechanisms to ensure transparency.
The Agency is committed to continuously extending its approach to transparency. A key goal in this process is the publication of clinical data for medicines once the decision-making process on an application for a European Union (EU)-wide marketing authorisation is complete. Clinical data are defined as clinical reports and individual patient data (IPD).
EMA will implement the policy in two phases.
- Phase 1 concerns the publication of clinical reports submitted to the Agency. It entered into force on 1 January 2015.
- Phase 2 concerns the publication of IPD. EMA will implement this phase at a later stage.
The Agency embarked on this process because it believes that the release of data will cement trust and confidence in the regulatory system, allowing the public to better understand the Agency's regulatory decision-making.
Early development of the policy
The process began with a workshop on clinical-trial data and transparency on 22 November 2012 to discuss the practical and policy issues that needed to be addressed before the Agency could begin to release these complex data sets.
Following the event, the Agency issued a call for nominations to join advisory groups to inform it on five topics. The groups met between January and April 2013, with meetings taking place via teleconference. For more information on the topics and the composition of the advisory groups see
- Clinical-trial-advisory-group memberships
- Clinical-trial-advisory-group memberships per affiliation category
The final advice from each group, as well as comments from the participants, is available under documents from advisory groups on clinical-trial data.
In June 2013, the Agency released the draft policy on publication and access to clinical-trial data for a three-month public consultation:
More than 150 individuals and organisations submitted over 1,000 comments. For more information see the overview of the outcome of the public consultation and overviews of comments:
- Outcome of public consultation on & Policy 0070 on publication and access to clinical-trial data: Summary of comments received during the public consultation and next steps
- Publication and access to clinical-trial data: list of stakeholders and stakeholder numbers
- Overview of comments from stakeholder 01 to stakeholder 88
- Overview of comments from stakeholder 89 to stakeholder 108
- Overview of comments from stakeholder 109 to stakeholder 126
- Overview of comments from stakeholder 127 to stakeholder 156
- Overview of comments from stakeholder 157 to stakeholder 169
The Agency reviewed and analysed the comments based on a set of key principles agreed by the Agency's Management Board on 12 December 2013. These included:
- a stepwise approach for implementation with, as a first step, preparation for the publication of clinical study reports redacted as appropriate;
- development of a methodology for de-identification of patients;
- definition of a standard format for the submission of data.
The principles also included the introduction of preliminary steps prior to data access designed to address the risk of possible unfair commercial use of data, while ensuring proactive and non-selective access ('use control' not 'access control').
Targeted stakeholder consultation
The policy was discussed at the March 2014 Management Board meeting and three meetings or teleconferences were held in May 2014 with patient and consumer organisations and healthcare professional organisations, pharmaceutical industry associations, including small and medium sized enterprises, and representatives from academia, research bodies, and medical journals.
- Finalisation of the EMA policy on publication of and access to clinical trial data – Targeted consultation with key stakeholders in May 2014: Summary report
The Management Board meeting on 12 June 2014 agreed that the policy would be finalised with a view to its adoption by the Board through written procedure by mid-July 2014. Subsequently the Management Board postponed the final discussion and adoption of the policy to the Management Board meeting on 2 October 2014.
In 2015 EMA consulted stakeholders extensively, as well as the European Ombudsman and the European Data Protection Supervisor.
Reactive release of documents
Since 2010 the Agency has been releasing clinical-trial reports on request, under its access-to-documents policy.
The access to documents policy enables third parties to request the release of documents held by the Agency, including documents submitted as part of marketing-authorisation applications. For more information, see Access to documents.