Europe – EMA : Mid-year report 2019

Brexit

Since the UK decision to leave the EU, EMA’s priority has been to ensure that the activities relating to the authorisation, supervision and maintenance of medicines are not disrupted and continue to be undertaken on time and to the same high level of quality the Agency’s stakeholders have come to expect, and that patients in Europe continue to have access to high quality, safe and effective medicines.

Information on the impact of Brexit and the Agency’s work to prepare for it and ensure uninterrupted operations can be found on the EMA website: https://www.ema.europa.eu/en/about-us/unitedkingdoms-withdrawal-european-union-brexit.

EMA Brexit preparedness and implementation

To address the challenges presented by Brexit, the Agency established an internal Operations and Relocation Preparedness (ORP) task force to plan and prepare for the changes, and developed and implemented in a staged manner a business continuity plan (BCP). This plan aimed to prioritise EMA activities in order to free-up the resources needed to prepare for Brexit, particularly the relocation, and to address potential staff loss. The ORP organisation and focus areas as well as the categorisation of the Agency’s activities for the purposes of BCP, are outlined in Annex 3.

BCP implementation:

The Agency implemented the first phase of its BCP in May 2017, ensuring delivery of its highest priority activities while temporarily scaling back or suspending lower priority activities. The second phase of the BCP was launched on 1 January 2018, affecting a further set of EMA activities, including medium priority activities.

On 1 October 2018 the Agency implemented phase 3 of the BCP, in order to safeguard core activities related to the evaluation and supervision of medicines, while intensifying the preparations for the Agency’s physical move to Amsterdam in March 2019 and coping with an increased number of resignations (a total of 25 in 2018, a 56% increase compared to the average number of resignations over 2013-2017)…