EMA publishes Brexit Preparedness Business Continuity Plan

The European Medicines Agency (EMA) has published its Brexit Preparedness Business Continuity Plan. The objective of this plan is to ensure that EMA’s operations continue, and that the risk to public health is reduced as far as possible, as the Agency prepares to relocate to a new host city.

The plan, which was presented to the EMA Management Board in October 2017, describes procedures by which EMA has categorised and prioritised its activities and how the Agency will reassign resources, when necessary, to ensure continuation of its core activities.

The plan discusses three levels of priority. Earlier this year, the EMA began to re-evaluate and reduce activities considered to be ‘category 3 activities’, in an attempt to make available 43 members of staff to focus purely on the UK’s withdrawal from the EU and the EMA’s relocation. Activities such as the development of the European Medicines Web Portal and EMA’s contribution to the e-submission project were temporarily suspended to achieve this. In the mid-to-long term, EMA will reconsider the need for these activities so as to not undermine the quality of the Agency’s work, its planning, and the expectations of stakeholders.

Category 2 activities, such as the proactive publication of clinical data, and a number of initiatives aimed at promoting availability of medicines, will be maintained for as long as possible, workload and staffing situation permitting, in order to maintain the development of new medicines. Category 1 activities, the highest priority, relate to the assessment and safety monitoring of medicines or are vital to maintaining the infrastructure of the European regulatory system for medicines. EMA consider the continuation of these activities to be crucial, as a disruption would almost immediately have a detrimental effect on the health and well-being of citizens in Europe and would also jeopardise production and distribution of medicines in the EU.

The plan will be continuously reviewed and adapted as necessary. Further iterations will also take into account various scenarios for staff losses and how these may affect the delivery of category 1 and 2 activities. Whilst the EMA has made the development of staff retention support measures a primary focus, unexpected higher, faster or more permanent loss of staff as a consequence of the Agency’s relocation may lead to a situation in which EMA’s operations can no longer be maintained.

The EMA plans to provide further updates on the implementation of its business continuity plan as necessary.

To access the latest plan, click here.