European Medicines Agency relocation: preparing for Brexit

Life Sciences 2

The vote on the European Medicines Agency (EMA) post-Brexit relocation is fast approaching and as a result there has been quite a lot of Brexit related activity recently, with some issues raising real concerns.

 

Relocation – where to next?

In September EMA published detailed comments and analysis on Member States’ bids to host its relocation post Brexit. The first part of EMA’s assessment was in relation to the proposed building itself, and EMA looked at matters such office space, disability access, available meeting rooms and other building facilities such as IT, security, conferencing, archiving and lounge facilities.  In addition, each Member State needed to put forward a relocation plan, proposing timelines and setting out how EMA would remain operational in order to guarantee business continuity. 

A summary of EMA’s technical comments can be found here, and for a summary of the results for each of the proposed host cities in grid format, click here.  

The second part of EMA’s assessment related to the accessibility of the location, existence of adequate educational facilities for children, access to the labour market, social security, medical care and maintaining business continuity.  Amongst other things, flight connections, accommodation facilities and the availability of public transport were considered. 

A summary of the EMA technical comments can be found here.  To see the results summary click here

The candidate locations, by way of reminder, are:

  • Amsterdam
  • Brussels
  • Lille
  • Malta
  • Athens
  • Bucharest
  • Milan
  • Vienna
  • Barcelona
  • Copenhagen
  • Porto
  • Warsaw
  • Bonn
  • Dublin
  • Sofia
  • Zagreb
  • Bratislava
  • Helsinki
  • Stockholm

Ministers of the EU27 will put the matter to a vote in November.

But are staff prepared to move?

Staff retention rates are a critical concern. It has been assessed that if retention falls below 30% following relocation, EMA will be unable to operate, leading to a public health crisis, medicines becoming unavailable, a reliance on third countries for importation and patients potentially exposed to life threatening situations. Permanent damage to the system is likely to occur. Even at the other end of the scale, if staff retention is 65% or more, it is assessed that the system could still take 2 to 3 years to fully recover.

Following a staff survey, EMA has revealed that the five preferred locations for staff relocation (achieving likely retention of 65% or more) were Amsterdam, Barcelona, Copenhagen, Milan and Vienna.  A summary of the results of the survey can be seen here.

EMA business continuity

On 16 October 2017 EMA published its “Brexit Preparedness Business Continuity Plan” which aims to safeguard the continuity of EMA’s operations to protect public health whilst EMA prepares to relocate to a new host city.  The plan will be continuously reviewed and adapted and can be viewed here.  Some of the key points arising out of the plan are as follows:

  • Ensuring the continuity of EMA operation under a “business as usual” scenario whilst also preparing for Brexit by maintaining current staffing and recruiting additional resources to compensate for staff losses. 
  • Implementing a phased approach by scaling back low priority EMA activities.  The aim of the first phase will be to free up the necessary resources to prepare for Brexit by temporarily suspending or reducing the output of the lowest priority activities.  The second phase will aim to ensure that activities with the highest priority can continue.
  • Category 1 (highest priority) activities will include core scientific activities such as dealing with public health threats and urgent safety issues. Complying with legal obligations (such as the handling of court cases and access to documents requests) as well as activities with a fee generating component (e.g. inspection fees) will also be prioritised.

We will provide a further update on the results of the EU27 vote in November. In the meantime if you have any queries please do contact our Life Sciences team.

Contact our experts for further advice

Paula Harris, Hannah Lunn

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