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European Medicines Agency departs London ahead of Brexit

Regulator moving to Amsterdam, as Novartis adds voice to no-deal warnings

On Saturday, EMA staff lowered the 28 flags of the EU member states and bid farewell to their London offices, as they start the physical move to the Netherlands.

The next phase of the relocation should be completed in a few weeks, when EMA workers start to move into the Spark building in Sloterdijk, Amsterdam, from 1 March. The entire workforce – less the 25% of staff who have opted not to make the move from London – should be in place by 15 March.

That won’t be the end of the story of course, as the Spark building is only a temporary home of the EMA until a permanent facility at Zuidas in Amsterdam is ready for occupancy. From 4 March the official address of the EMA will be the permanent unit at Domenico Scarlattilaan 6, 1083 HS Amsterdam, although meetings will be held at the Spark building.

Guido Rasi

Guido Rasi

EMA executive director Guido Rasi expressed his thanks to the UK for its contribution to the work of the agency and for having been a gracious host of EMA since 1995. Progress on the move can be monitored via an EMA tracking tool.

In a statement issued last week, the EMA said it will narrow its focus on critical activities such as “the authorisation, maintenance and supervision of medicines, ongoing Brexit preparedness/implementation activities and preparing for the implementation of the new veterinary legislation” during the relocation process.

Once the new building is fully staffed and operating in April, the EMA will consider what other elements of its workload it can resume in the second half of 2019.

A new annex document published on 23 January details the high priority (category 1) activities that the EMA will focus on in 2019. That list includes public health issues including the availability of medicines – for example by tackling the threat of drug shortages – and antimicrobial resistance (AMR), as well as ensuring “timely access to new beneficial and safe medicines for patients.”

EMA

The closure of the Canary Wharf location in London means that some committee meetings due to take place in the next few weeks, including the February meetings of the Committee for Advanced Therapies (CAT) and the Biologics Working Party (BWP), will take place at the Spark building.

The EMA’s move from Canary Wharf has been overshadowed by a property dispute currently in front of the High Court – which is thought to be one of the first directly related to the UK’s planned departure from the EU on 29 March.

The EMA is battling the owners of Canary Wharf over the right to break its 2011 lease on the Churchill Place building, with the regulator arguing that Brexit amounts to “an event of frustration” that in legal terms means it has the right to terminate early. The Canary Wharf Group is arguing Brexit was predictable as the Conservative party manifesto contained a pledge for an EU referendum in 2010, and is trying to hold the EMA to the original lease terms.

The outcome of the lawsuit – which is expected before 29 March – could have consequences for other businesses with leased facilities opting to relocate away from the UK  as a result of Brexit.

Novartis adds voice to no-deal Brexit clamour

Meanwhile, Novartis has become the latest drugmaker to issue a stark warning about the consequences of a disorderly Brexit on the supply chain, saying it is stockpiling to ensure it can continue to provide the “120 million packs of medicines we import to the UK from Europe each year.”

It has urged the government to put a plan in place that goes beyond the NHS and Department of Health and Social Care to ensure medicines can reach patients in the event of no-deal.

That includes “clarity over customs arrangements, both to and from Europe, and to minimise disruption at our borders,” it says.

Novartis also urges NHS trusts and pharmacists to adhere to the government’s advice not to stockpile medicines so supply can be managed centrally.

Article by
Phil Taylor

28th January 2019

From: Regulatory

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