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A new study from Charles Rivers Associates, commissioned by the European Federation of Pharmaceuticals Industries and Associations (EFPIA), highlights "some very real risks to public health" as a result of the relocation of the European Medicines Agency (EMA). Published today, Assessing the impact of the disruption from the relocation of the European Medicines Agency examines the impact of relocation of the agency as it leaves London and makes its new home elsewhere in the European Union.
The report signals two main risks to the EMA's capability to undertake its critical role; the agency's ability to call on, and manage the significant network of expertise it relies on to support its activities, and its ability to retain its existing staff and capacity in the context of the relocation.
Out of the five main functions of the EMA, the report highlights the evaluation of applications for marketing authorisation and monitoring the safety of medicines across their lifecycle as having the most significant detrimental effect on public health if impacted by relocation. Delays in evaluating applications for marketing authorisation means delays in access to new medicines for patients across Europe. Disruption to critical safety functions can lead to delays in identifying, management and communication of safety issues, putting patients at risk. Transitional arrangements must be put in place to ensure the agency has the time to manage the relocation and safeguard public health.
Commenting on the report, EFPIA Director General, Nathalie Moll said, "The EMA plays a key role in Europe's health, ensuring that medicines are safe, effective and of high quality. This report underlines the importance of both the location decision and transitional arrangements to the agency's future. Supporting the continuity of its critical functions, its ability to retain staff and access expert networks is central to its future and to public health."