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EMA ensures business continuity while preparing for Brexit

In the beginning of August, the EMA issued a press release on the functioning of its business continuity plan to deal with the uncertainty and workload implications linked to Brexit.

The plan, which was developed after the UK referendum and endorsed by the EMA Management Board in June 2017, aims at ensuring that the assessment of medicinal products is not disrupted and that patients continue to have access to high quality, safe and effective medicinal products in Europe.

The plan classifies the EMA’s activities by order of priority, according to their impact on public health and the EMA’s needs to function. As of now, three categories of activities exist:

    • Category 1 includes the highest priority activities that are crucial to be upheld and (i) directly relate to the assessment and safety monitoring of medicinal products or (ii) are vital to maintaining the infrastructure of the European regulatory system for medicinal products (e.g. the coordination of actions to protect the safety of patients in all EU Member States, and inspections across the EU).
    • Category 2 corresponds to activities that are considered as too important for the functioning of the EMA to be suspended, even temporarily. These activities include, for example, proactive publication of clinical data, EMA’s contribution to the fight against antimicrobial resistance or its interactions with Health Technology Assessment bodies. Category 2 activities will be maintained for as long as possible, to ensure that the development of new medicinal products is preserved.
    • Category 3 concerns activities that may be put on hold for some time to channel resources into the core activities that absolutely need to be maintained. For example, category 3 encompasses the development of the European Medicines Web Portal (i.e. a new publicly-available online information source on all medicines marketed in the EU) and the development of a transparency roadmap that lays out future transparency measures of the EMA.

The EMA reports that the status of Category 1 and 2 activities is currently “business as usual”, while since May, it has started to scale back Category 3 activities to free up 43 staff by the end of 2017 who are focusing on the preparations for the UK’s withdrawal from the EU and EMA’s relocation. The activities that were scaled back include audits, corporate governance, and support activities as well as participation in and organisation of meetings and conferences.

The information note states that the EMA will provide further updates on the implementation of the business continuity plan as necessary (for example, if the delivery of category 1 and 2 activities would become affected), and specifically mentions a “worst case” scenario where “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.”

This post was originally co-authored by Audrey Aboukrat.

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