The European Medicines Agency (EMA) said it expects to launch the next phase of its business continuity plan on October 1, 2018 at the latest. The plan will allow the agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.
The agency reported that it will lose more staff than initially anticipated, forcing temporary cuts in activities. Staff who will not relocate to Amsterdam already have started to leave the agency and the trend is expected to accelerate.
In addition, due to the employment rules in the Netherlands, 135 short-term contract staff no longer will be able to work for EMA. Overall, EMA expects a staff loss of about 30 percent, with a high degree of uncertainty regarding mid-term staff retention.
EMA said it has put in place supporting measures to facilitate the relocation of staff to Amsterdam and additional support is provided by the Dutch government. Other mitigating actions, such as a comprehensive staff recruitment program, already are underway.
However, in the short- to mid-term, EMA will have to re-prioritize its resources to fully maintain its core activities related to the evaluation and supervision of medicines to the level of quality and within the timelines expected.
Following the implementation of phase 1 and 2 of the business continuity plan, in phase 3 EMA will start to temporarily scale back or suspend additional activities through to 2019. The move contributes to protecting EMA’s essential public health activities and allows for training of EMA staff who will be reassigned to new duties ahead of the peak relocation time which will start in early 2019.
Activities initially impacted by phase 3 include:
- 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 harmonization 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;
- Programs and projects, where activities in relation to project governance will be reduced in line with the reduction/suspension of projects;
- Organization 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 August 1, 2018; data packages submitted for medicines until the end of July 2018 will be processed and finalized.
The implementation date for phase 3 of EMA’s business continuity plan is no later than October 1. The agency said that detailed plans for the implementation of the measures are currently being developed and will be communicated to stakeholders concerned and the public as soon as they are available.
(Source: European Medicines Agency)
