EMA Management Board: highlights of October 2017 meeting

From Drug Discovery Today - October 6, 2017

Brexit preparations

At its 5 October 2017 meeting in London, the Management Board of the European Medicines Agency (EMA) was updated on the Agencys ongoing preparations for the withdrawal of the United Kingdom(UK) from the European Union (EU).

The European Commissions assessment of the 19 Member States bids to host the Agency, which EMA contributed to, was published on 30 September 2017. EMA released its comments on the offers of the Member States on 3 October. The General Affairs Council of the European Union is scheduled to decide on the Agencys new location on 20 November 2017.

Reflecting on EMAs comments on the Member States bids, Nol Wathion, EMAs Deputy Executive Director, stressed that the accessibility of the new premises for delegates and experts, and staff retention, are key to ensuring the Agency remains operational and able to deliver on its mission after its relocation. This needs to be supported by adequate premises and facilities. By explaining the methodology used, he was able to address concerns regarding EMAs assessment raised by a few Member States.

Yann Le Cam, patient representative on the Board and Chief Executive Officer of Eurordis commented,EMA is a key asset of the European Union to make it an attractive place for medical innovation and job creation. The decision where to locate EMA as of March 2019 should not be based on what EMA would bring to the new host country, but on whether the new host country has what it takes to preserve the value EMA brings to patients in the European Union. The capacity of the new host city to retain current staff and attract new people at the same level of quality is key for this.

In view of the challenges EMA will face over the next few years, the Board initiated an early discussion on the implications for the draft budget for 2018 and the preliminary draft budget for 2019.

While no firm predictions can be made until the new location of the Agency is known, EMA is anticipating staff losses which will not only challenge the Agencys operability but could also result in a major deficit in its budget. If operations are delayed or have to stop because of massive staff losses, theAgency could experience a dramatic drop in fee income which would in turn result in reduced payments to the national competent authorities. The financial consequences would be further exacerbated by the cost of replacing staff. Such shortfall would need to be made up from the Union budget.

The final budget will be proposed to the Board in December, after the new location of the Agency is announced in November.

The Board also heard an update on progress made by the EMA working groups on Committee preparedness for human and veterinary medicines. The groups discussed how the workload that is currently carried out by the UK in relation to the assessment of medicines will be distributed among the EU27 after the UK has left the EU. Further meetings will be held in November with a view to finalising recommendations for the Management Board at their next meeting in December.

The Management Board was informed about the next phase of EMAs Brexit preparedness business continuity plan to be launched as of 1 January 2018. The Management Board agreed to continuously analyse the impact of this plan, which will be released next week.

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