The European Medicines Agency (EMA) has published the final advice from the advisory groups that have been set up to inform the EMA in drafting its policy on proactive access to clinical-trial data. The EMA has committed to the proactive publication of data from clinical trials supporting the authorisation of medicines once the marketing-authorisation process has ended, which the EMA does not consider commercially confidential. The release of data is ultimately about establishing trust and confidence in the system.The EMA is committed to transparency and openness of information to meet the legitimate public interests to enable scrutiny of the Agency’s recommendations on medicines.
In November 2012, the EMA organised a workshop to gather the views, interests and concerns of a range of institutions, groups and individuals with an interest in the topic. Following the event, the EMA issued a call for nominations to join advisory groups to inform the EMA on five specific aspects: protecting patient confidentiality, clinical-trial-data formats, rules of engagement, good analysis practice and legal aspects. More than 200 people from all stakeholder groups applied to participate in one or more advisory group. The groups met between January and April 2013, with meetings taking place via teleconference. The EMA would like to thank all members of the advisory groups for their availability and valuable participation in the discussions.
Next step: drafting a policy
The EMA will now be drafting a policy on proactive access to clinical-trial data. During the advisory group discussions, stakeholders sometimes expressed divergent views and suggested different options on particular aspects. These different viewpoints are reflected in the final advice from each group. When drafting its policy, the Agency will make the final decision on what options to choose. The Agency is aware of patients’ concerns regarding the protection of personal data. Its policy will take these concerns into account and ensure that personal information on patients is adequately protected. The Agency also acknowledges that analysis by independent groups is not always equivalent to it being free of conflicts of interest and of high quality and it intends to address these aspects in its policy.
The policy will also ensure transparency in the best interest of public health without impinging on the company’s intellectual property rights. A sustained and high level of investment in pharmaceutical research is important for future improvements in public health. The EMA’s policy will be designed to guard against any unintended consequences, e.g. on intellectual property, that might disincentivise future investment in R&D. The EMA’s policy intends to find a fair balance between access to clinical-trial data and rules for engagement. The EMA will publish its draft policy at the end of June 2013. Anyone will then have the opportunity to comment on the draft policy during the phase of public consultation which will last until the end of September 2013.
The final policy will be published at the end of November 2013. The Agency expects the policy on proactive publication of clinical-trial data to come into force on 1 January 2014.
Ongoing court cases
A number of court cases are currently ongoing which will bring the opportunity for legal clarification of the concept of commercially confidential information. The outcomes of these court cases will be taken into account in the finalisation of the policy.