As currently reported in our Brexit Blog, one of the first and most visible consequences of Brexit was EMA’s relocation to the Netherlands. EMA’s seat formally changed from London to Amsterdam on March 30, 2019, but preparatory work for the move started well before that date.

From the moment the UK triggered Article 50, EMA wasted no time in getting ready for its relocation whilst continuing to deliver on its mission to protect public and animal health.

And yet, the relocation efforts are not fully over. Since March 2019, EMA has worked in temporary premises in the Sloterdijk area of Amsterdam and will move to its new permanent headquarters in Amsterdam Zuidas in January 2020.

At the same time, and as also reported in our Blog, EMA had to handle a battle over its former premises in London. EMA settled a court case with Canary Wharf Group by subleasing its London offices to the shared office group WeWork. However, WeWork has been itself looking vulnerable since its failed IPO and there is uncertainty as to where all this could lead up to as the sublease is expected to last until the original lease expires in 2039.

How has all this impacted on the Agency’s mission and work programme?

Business Continuity Plan

To ensure business as usual with the minimum disruption, EMA developed a detailed Business Continuity Plan, which prioritised tasks and activities according to their impact on public health. Under the plan, lower priority activities were temporarily suspended to allow focus on activities of high priority related to the authorisation and supervision of medicines. The plan was last updated in June 2019 and some previously suspended activities were reinstated whilst others, such as guideline development or working party meetings, still remain on hold.

Regulatory preparedness

In addition to work related to the relocation, EMA and the European Commission worked actively on the development of guidance to ensure that pharmaceutical companies are ready for Brexit and can guarantee continued supply of medicinal products.

EMA also adapted the centralised regulatory procedures to the planned UK’s withdrawal from the EU. This involved the redistribution of existing UK (co)rapporteurships (i.e. contracts for assessment of medicines) amongst the national competent authorities of the EU27. Assessment of over 370  centrally authorised products was gradually transferred and no new rapporteurships have been awarded to the UK since. The new rapporteurs obtained the full responsibility of these assessments in March 2019 (date when the UK was initially expected to withdraw from EU).

EMA designed the redistribution policy under the scenario that the UK would become a third country as of March 2019, hence the redistribution ahead of time. Until Brexit date, the UK continues to participate in all formal meetings and retains its voting rights.

Staff losses

One of EMA’s main concerns during the relocation process has been staff retention. At the end of 2018, before the physical move to Amsterdam, EMA’s staff count was 901. In June, the number had decreased to 776 and at the latest Management Board meeting held in October 2019, EMA’s Executive Director announced a further 6% staff reduction, with a headcount of approximately 730.

This is seen as a challenge given the additional workload that is required at present for the implementation of the new legislation for veterinary medicines, medical devices and clinical trials.

EMA has carried out selection procedures to compensate for these losses. However, it has also announced that it does not expect to reach the numbers held before the relocation. 

Regulatory Science to 2025

Despite the challenges of Brexit, EMA has made clear its determination to not lose focus on its mission to protect public health and its drive to remain at the forefront of medicines development.

The best reflection of this is the EMA Regulatory Science to 2025 strategy published in 2018 following a 6 month consultation process. The Agency’s priority is to be prepared for the fast-paced developments in science and innovation of current times.

Structural reorganisation

At the last management board meeting of October 2019 the Agency also announced that it is planning a review of its organisational structure with an aim to focus on key priority areas such as digital business transformation, data analytics and methods, regulatory science and innovation, clinical trials and a manufacturing strategy. The reorganisation is also aimed at strengthening the therapeutic focus in the area of human medicines.

So… what next?

Brexit has had an inevitable impact on the work of EMA in the last years. The Agency has joined efforts to ensure business as usual and avoid disruption as far as possible. EMA has also been keen to promote its role as a regulator able to support and promote innovation. Will EMA be able to fully focus on this and leave Brexit behind? Time will tell.

For further information please contact Magda Tovar, Els Janssens or Julia Gillert of our London office.

Author

Julia Gillert is a Senior Associate in the Corporate Department of Baker & McKenzie's London office and is a key member of the Healthcare industry group within the London office and European and Global networks. Julia advises both domestic and international companies in the med-tech, pharma and healthcare sectors on a wide range of regulatory and general compliance matters. Julia has contributed to a variety of regulatory healthcare related publications and practice handbooks and co-edits the firm's European Healthcare Newsletter. Julia sits on the ABHI's Legal Issues Committee.

Author

Els Janssens is a senior associate in our Abu Dhabi office and provides knowledge management support to Baker & McKenzie’s global and MENA Pharmaceutical and Healthcare industry group. Els started her career in 2000 at Baker and McKenzie in Brussels focusing her practice on pharmaceutical law and commercial litigation. She has worked six years in London as a legal adviser with the European Medicines Agency (EMA). During this period she has supported the EMA’s activities in medicines oversight and regulation and interacted with the European Commission on legal matters relating to medicinal products. She also worked one year as senior legal counsel in Johnson & Johnson’s European legal department providing regulatory advice regarding various medicinal products and supporting the public affairs function on new legislation.

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