EMA reveals ‘business continuity plan’ for Brexit, cuts resources from non-essential areas
The uncertainty caused by Brexit has been and continues to be far-reaching, and perhaps most impactful for business, organisations and their practices. The EMA is no exception, and due to the anticipated disruption surrounding the outcome of negotiations, the agency has released a continuity plan outlining its intentions to mitigate implications on its workload.
Given the magnitude of potential changes as a result of Brexit, the agency will be reallocating its resources for the next few years, prioritising areas of its operation which have the greatest impact on public health and overall functionality. These areas have been divided into three layers of importance – in May this year, the agency began to scale back investment of its resources in the outermost of these three layers, in order to free up 43 staff by the end of the year. These staff will instead be dedicated to issues relating to the Brexit process and the relocation of the EMA from its London headquarters.
This means that several areas will unfortunately by downsized or suspended, including the development of the publicly-available European Medicines Web Portal, a roadmap for improved transparency within the agency, and an e-submission platform for the secure request for authorisation of medicines.
The agency plans to assess the length of time these activities can be put on hold before they begin to impact the quality of its work.
Category 2 activities, which include clinical data publication, interactions with Health Technology Assessment bodies, and initiatives focused on drug access, will be maintained, “as long as possible”, according to the agency, “workload and staffing situation permitting”.
Category 1 activities, such as medicine assessment, safety monitoring, and maintaining the European regulatory infrastructure, are deemed essential and will not be affected. The agency has stated that this operational plan will be reviewed in light of staff losses and the like, though negative, unforeseen impacts of the relocation of its headquarters could “lead to a situation in which the EMA’s operations can no longer be maintained”.
“Preparing for the move, managing the necessary changes, and addressing challenges such as possible losses in skilled and experienced staff, in a proactive and efficient way requires considerable internal resources,” said Noel Wathion, EMA’s Deputy Executive Director and head of EMA’s Brexit task force. “With the business continuity plan we aim to ensure that the assessment of medicines is not disrupted and that patients in Europe continue to have access to high quality, safe and effective medicines.”
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