Relocation to the Netherlands and preparations for Brexit
EMA’s relocation to Amsterdam
On 20 November 2017, EU Member States decided to relocate EMA to Amsterdam in the Netherlands as a result of the UK’s decision to withdraw from the EU. The announcement of EMA’s new location marked the next phase of the challenging relocation project and the Agency immediately began working with the Dutch authorities to prepare for the move and take up its operations in Amsterdam. 2019 was a critical year for EMA as it was important to avoid major disruptions while the Agency and a large majority of its employees had to leave its premises in London and reinstate operations in its new home, in a two-step approach, the first step being the move to its temporary premises in 2019.
Key relocation milestones in 2019 are outlined in the following timeline:
1 January - EMA’s temporary premises, the Spark building in Amsterdam Sloterdijk is fully operational.
1 March - Last working day in the London premises.
4-8 March - All EMA staff telework.
11-15 March - Staff gradually move into the Spark building.
30 March - Amsterdam formally becomes the new seat of EMA.
March-December - EMA operates out of the Spark building.
15 November - The Dutch authorities confirm practical completion of the fully fitted and furnished EMA building which is tailor-made to the requirements of its operations. The premises are located in the Zuidas area of Amsterdam.
Nov-Dec 2019 - Installation and testing of IT and AV technical equipment makes the new building operational; furniture is moved from the temporary premises to the new building.
Looking ahead to 2020 - Staff will gradually move into the final premises as of 13 January 2020 and the first meetings will take place in the same week.
The move into the EMA building marks the final step of the Agency’s relocation journey to the Netherlands.
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The EMA building – key facts and figures:
The EMA building is located in the business district of Amsterdam Zuidas.
It was commissioned by the Dutch government represented by the Central Government Real Estate Agency (CGREA) as the developer and future landlord under a design-build-maintain contract with a consortium of two Dutch construction companies.
It has 1,300 working spaces with a total net lettable area of approximately 33,000 square metres.
It has a BREEAM ‘Excellent’ rating and an Energy Label A++.
It has been built with high environmental awareness and an ambition to contribute to the future green corridor through Amsterdam Zuid.
It is a nearly-zero-energy building.
It has a conference centre with an auditorium where public hearings can be held (with seats for approximately 300 people).
The new EMA building provides tailor-made, state-of-the-art working spaces, into which the Agency can grow in the future. It is a symbol of stability and security for all EMA colleagues, after our long relocation journey. Seeing this building gives me reassurance that we can continue advancing our public health mission and can meet the challenges ahead with confidence and enthusiasm.
Because of its important role in safeguarding public and animal health in the EU, EMA committed to giving stakeholders and the public full visibility of its relocation project. A tracking tool on the EMA website enabled interested parties to track progress made during the relocation project.
EMA confirmed the sublease of its London premises at 30 Churchill Place
EMA reached an agreement with Canary Wharf Ltd over its premises at 30 Churchill Place, London, in accordance with the EU budgetary authority’s decision. EMA sublet its 26,450 sqm at 30 Churchill Place to a subtenant who took a sublease from EMA until the expiry of EMA’s lease in June 2039.
Business continuity planning
EMA’s move to Amsterdam forced the Agency to re-prioritise its activities and amend its workplan. To enable the Agency to deal with the logistical and administrative challenges of the relocation and to cope with the loss of staff, EMA implemented phase 4 of its business continuity plan at the beginning of 2019. This enabled the Agency to continue focusing its efforts to safeguard core activities related to the evaluation, maintenance and supervision of medicines.
Most activities that were temporarily suspended or reduced at the end of 2018 as part of phase 3 of EMA’s business continuity plan (BCP) remained on hold in 2019: for example, guideline development (unless exceptions were agreed), engagement in international activities, most working party meetings, and the Agency’s proactive publication of clinical data.
From June 2019, the Agency was able to reinstate a small number of activities, mainly those aimed at ensuring that the Agency is fit for purpose in the longer term. These included, for example, IT systems supporting the medicines evaluation process and the digitalisation of administrative processes.
In addition, some of the EU network working groups directly contributing to EMA’s core activities restarted. Specifically, meetings of the Good Manufacturing and Distribution Practice, the Inspectors Working Group, the Good Clinical Practice Inspectors Working Group, the Pharmacovigilance Inspectors Working Group, the Quality Working Party, and the Process Analytical Technology (PAT) team resumed their work in September 2019.
Similarly, meetings of the Patients and Consumers Working Party (PCWP) and the Healthcare Professionals Working Party (HCPWP) restarted as of September 2019.
IMPACT OF RELOCATION ON STAFF NUMBERS
By the end of the year, the Agency’s available workforce was 775 – significantly less than at the end of 2017 when EMA’s relocation plans took shape.
The Agency’s major recruitment drive continued in 2019 to make sure that staff who decided not to relocate to Amsterdam or were unable to could be replaced as soon as possible.
To help the Agency make best use of available resources and to be best prepared for future challenges, EMA initiated an in-depth review of its organisation in 2019. This ‘future-proofing’ exercise will help EMA to strengthen its ability to perform important new activities together with the European medicines regulatory network and tackle important challenges ahead, such as big data, digitalisation and new scientific methods and technologies.
Operations in the area of human medicines will be integrated to strengthen the therapeutic focus throughout a medicine’s life cycle, with the ultimate aim of assuring the quality of scientific opinions and further enhancing support to EMA’s scientific committees. Four task forces will focus on areas that are also key priorities for the network, such as digital business transformation, data analytics and methods, regulatory science and innovation, and clinical trials and manufacturing strategy.
The new structure will come into effect in Q1 2020.
Preparing for Brexit
Brexit-related guidance for companies
EMA, the European Commission and the Member States continued to work closely together to provide guidance to help companies marketing human and veterinary medicines in the EU to prepare for the UK’s withdrawal from the EU and minimise the impact on the supply of medicines. This was aimed at ensuring that companies would be ready to take the necessary steps to enable undisrupted supply of their medicines in the EU for the benefit of patients, based on the assumption that the UK would become a third country after Brexit.
Despite the proactive approach taken by EMA and the network, there was still the risk of supply issues with some centrally authorised medicines if the UK were to leave the EU without a withdrawal agreement, in particular around the three Brexit deadlines of 31 March, 12 April and 31 October 2019. Consequently, the Agency closely monitored the evolving situation and continuously liaised with pharmaceutical companies about their Brexit preparedness.
By the end of 2019, good progress had been made by companies to take the required steps to ensure that their centrally authorised medicines could remain on the EU market. Just one marketing authorisation transfer for a human medicine was still pending. Good progress was also made for products with qualified persons for pharmacovigilance (QPPVs) still based in the UK (58 still to be transferred) and pharmacovigilance master files (PMFs) based in the UK (64 still to be transferred).
Redistribution of UK portfolio of medicines
In preparation for Brexit, the EU27 Member States and EMA had started the redistribution of the UK’s portfolio of medicines to other EU Member States in 2018. By 1 July 2019, the appointed rapporteurs and co-rapporteurs from the EU27 plus Iceland and Norway took over full responsibility for more than 370 centrally authorised products which previously had UK rapporteurs or co-rapporteurs.