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Regulations & EHS&S



The EMA is moving!

By our Editorial Team - 08/01/2018

The decision to relocate the EMA was taken on 21st November 2017, following the UK’s decision to withdraw from the EU, by the 27 EU Member States in the margins of the General Affairs Council (Article 50).

The European Medicines Agency (EMA) now has little more than a year remaining, before it must move and take up operations in Amsterdam by 30th March 2019.1 The new EMA headquarters will be located in the Vivaldi Building, a new office building in Amsterdam Zuidas or ‘South Axis’, situated within the city of Amsterdam and only minutes away from Amsterdam Airport Schiphol.

Although it was not unexpected, the announcement caused shock waves in the pharmaceutical industry. Primarily, people wondered how the EMA, which has been housed at Canary Wharf in London since 1995, would be able to re-locate to Amsterdam in less than 16 months.

“It will be difficult!” declared Nicola Travierso, President of Velit Bio. “I understand that the Netherlands authorities have already declared that for 1 year after the 16-month deadline the EMA building will not be fully ready; personnel will need to be accommodated in various existing structures, and we might expect difficulties in coordination/communication during that period.”

In fact, it has been confirmed that as the tailor-made Vivaldi building is planned for completion in November 2019 – several months after the planned relocation date – the Dutch government will offer temporary premises to EMA from 1st January 2019, or earlier if requested by EMA, until the new building is ready.

There are obvious concerns that the move will lead to a gap in personnel, or other disruptions that may detract from the Agency’s ability to provide a ‘normal service’. In general, it is expected that senior management will probably move to Amsterdam, while medium- or lower-level employees are likely to be less motivated to make the move. This could create a gap in the workforce, and a potential break in continuity of knowledge and services, although things could be worse...

“There is always a risk of staff leaving when a move such as this occurs, however the move to Amsterdam might have much less of an impact than if the vote had favoured a city such as Bratislava. However, it remains to be seen what the full impact will be, especially given the role the MHRA has currently in the EMA’s working”, advised Bruno Speder, Head Clinical Regulatory Affairs & Consultancy at SGS Life Sciences – Clinical Research, in a conversation with Chemicals Knowledge Hub.

On 18th December, an EMA Management Board meeting provided an update on Brexit preparations. This was the first meeting of the Board since decision to relocate the Agency to Amsterdam, and it was openly acknowledged that EMA’s preparations for the UK’s withdrawal from the EU will impact on the activities of the Agency.2

“We might see delays in scientific advice procedures and marketing authorisation applications (MAA). The biggest impact however, could be the delay in the implementation of the new EU clinical trial regulation 536/2014,” cautioned SGS Life Sciences’ Bruno Speder.

However, encouragingly, a number of positive steps had already been made. Primarily, EMA’s collaboration with the Netherlands commenced promptly, and agreement had already been reached – by the date of the Management Board meeting – on the joint governance structure, with plans to progress activities within five work streams relating to the temporary and permanent premises, staff relocation, financial and legal aspects, and external communication.

A delegation from the Dutch government attended part of the Management Board meeting. The delegates presented the next steps regarding the relocation process and explained how the Dutch authorities plan to meet EMA’s requirements. According to a statement released by EMA,2 “The Board was pleased to hear that the Netherlands are committed to ensure a seamless transition of the Agency’s operations in the course of the relocation to Amsterdam.”

The Board was also informed that EMA’s Brexit preparedness business continuity plan will enter Phase 2 in January 2018, in order to free up further resources needed to prepare for the withdrawal of the UK from the EU. The Agency has plans to redistribute the work currently carried out by the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD). The redistribution plan reflects the strengthened capacity of the European medicines regulatory network, and takes into account the diverse expertise in the network and the workload associated with the medicines.

The EMA and the European Commission are providing guidance to help pharmaceutical companies prepare for the UK’s withdrawal from the EU. The aim is to ensure that companies are ready to take the necessary steps to enable undisrupted supply of their medicines for the benefit of patients, based on the assumption that the UK will become a third country as of 30th March 2019. 

Among the people that Chemicals Knowledge Hub spoke to after the announcement, there is currently a relaxed attitude, despite underlying concerns about potentials delays in Agency deliveries.

For example, Velit Bio’s Nicola Travierso was characteristically pragmatic, and SGS Life Sciences’ Bruno Speder pointed out that the role of the MHRA will be compensated and filled by other agencies (e.g. in some of the areas surrounding clinical trials, the Belgian Agency, which has a strong experience in early phase development and vaccines, could take over from the MHRA).

And one reassuring fact we can all rely on is that we’re all in it together!

Companies are advised to check the EMA’s Brexit-related guidance for companies website page3 regularly for guidance on the consequences of Brexit, as EMA and the European Commission are preparing a series of guidance documents.

References
1. EMA. Press release, 21st November 2017.
2. EMA. Press release, 15th December 2017.

3. EMA. Brexit-related guidance for companies, www.ema.europa.eu