EMA pulls back on activity, with 30%+ staff losses expected

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Pixelci)
(Image: Getty/Pixelci)

Related tags Ema Brexit Clinical trials Pharmacovigilance

The EMA has revealed that it is having to cope with “significant staff losses” due to Brexit, which means that it will have to temporarily cut certain activities.

The European Medicines Agency (EMA) announced that a number of staff have chosen not to move along with the Agency to Amsterdam​. This has resulted in staff leaving the Agency prior to the official moving date on March 30, 2019.

In addition, employment regulation in Amsterdam means the Agency will no longer be able to employ 135 short-term contract staff. All told, the EMA expects to lose 30% of its staff – an estimate that could rise, as it noted “a high degree of uncertainty regarding mid-term staff retention”​.

The Agency admitted that this amounted to the departure of “more staff than initially anticipated”​.

In a press release​, it listed the activities that will be impacted:

  • Collaboration at international level, which will be temporarily scaled back to focus primarily on product-related requests, supply-chain integrity and procedures under Article 58; in other areas, such as the harmonisation of global medicine regulation, EMA will only take a reactive role; EMA’s engagement in other global public health issues such as antimicrobial resistance or vaccines will be maintained as long as possible, but reviewed on a case-by-case basis
  • Development and revision of guidelines, which will be temporarily limited to those guidelines that address an urgent public/animal health need or are necessary to support and facilitate preparations for Brexit
  • Holding of non-product-related working parties, which will be temporarily reduced as a consequence of the scaling back of guideline development or revision
  • Programmes and projects, where activities in relation to project governance will be reduced in line with the reduction/suspension of projects
  • Organisation and attendance at stakeholder meetings, which will be limited to Brexit-related interactions
  • Clinical data publication, for which the launch of new procedures will be temporarily suspended as of 1 August 2018; data packages submitted for medicines until the end of July 2018 will be processed and finalised

To protect the services the regulator currently provides, it revealed that it has already developed a recruitment plan to make up for the staff shortfall. It will also reprioritise its task to ensure that its core responsibilities are not damaged.

It will announce its business continuity plan by October 1, at latest, where it will update stakeholders and the public on phase 3 of its plans to mitigate the impact of Brexit.

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