EMA temporarily scales back and suspends activities due to higher than expected staff losses
As Brexit edges nearer, the European Medicines Agency has revealed further temporary scale backs and suspension of activities as a result of higher than expected staff losses resulting from its move from London to Amsterdam.
The agency revealed that it will be launching its next phase of its business continuity plan on 1 October 2018, which will see it scale back, limit and suspend some non-urgent activities for a temporary period of time while it deals with securing essential public and animal health activities.
These restrictions on activities have become necessary as the EMA is preparing to lose about 30% of its staff and is uncertain regarding the retention of mid-term staff in light of the relocation to Amsterdam.
In a statement the agency specified: “The temporary cuts in activities are required because it has also become clear that the Agency will lose more staff than initially anticipated. Staff who will not relocate to Amsterdam have already started to leave the Agency and this trend is expected to accelerate.”
The specific activities that will be affected in the next phase of business continuity for the EMA include:
- International collaborations— this will be scaled back temporarily so the agency can focus on product-related requests, supply-chain integrity and procedures under Article 58. A reactive role will be taken in other areas and engagement in global public health issues will be maintained as long as possible but will be reviewed case-by-case.
- Scientific guidelines— a temporary limit is being placed on this activity so that development and revision of guidelines will only happen for those that address an urgent public/animal health need or those needed to support and facilitate Brexit preparations.
- A temporary reduction will be placed on non-product related working parties, which is 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— new procedure launches 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.