UK pharma sector faces – crisis – without early Brexit deal, uk pharma.#Uk #pharma


Posted On Jul 3 2018 by

UK pharma sector faces ‘crisis’ without early Brexit deal

T he UK pharmaceuticals sector has been told to prepare for a “crisis” Brexit scenario of drastically reduced access to European markets and hundreds of millions of pounds of restructuring costs unless a swift regulatory deal can be struck with Brussels.

Trade body the Association of the British Pharmaceutical Industry (ABPI), which lobbies for the 60,000-strong sector, told The Telegraph new regulatory guidance published by the European Medicines Agency (EMA) this week posed a risk to UK pharma jobs and to public health on both sides of the Channel.

The EMA – one of two highly-prized EU regulatory bodies currently based in the UK that is expected to move to the Continent – issued a paper detailing how firms should prepare for Brexit.

In it the regulator advised UK-based pharma companies to move hundreds of roles and functions to an EU member state ahead of Brexit in order to maintain their existing rights to sell medicines in the common market.

Among the demands are that EMA-approved medicine batching facilities and 153 UK-based EMA-approved experts that monitor the safety of European drugs move to an EU member state.

The paper also warned that as things stand the UK faces a sharp hike in regulation and stringent checks on medicine exports from March 30, 2019, in terms of finished products when they arrive in the European common market.

D r Virginia Acha, executive director of research, medical and innovation at ABPI, described the EMA’s paper as the “opening chapter in this crisis”.

She estimated restructuring costs arising from UK pharma companies taking up the EMA’s guidance would run to “hundreds of millions of pounds”.

But she cautioned that the EMA document outlined only one scenario, “the hardest of hard Brexits”, and highlighted the “critical importance” of politicians, regulators and companies working to strike a compromise deal before Brexit.

Ms Acha said: “Rather than a fast decision, let’s get the right decision… The proposals represent a very significant change and preclude the possibility of a better decision.”

She also warned that the EMA guidance overlooked “the public need issue” for close co-operation between drug regulators on both sides of the Channel, to avoid a cliff edge regulatory scenario, and argued medicines should be treated “like policing or welfare in the Brexit negotiations”.

“We want to make sure medicine in the UK and Poland still gets there as planned from day one,” she added.

The EMA is currently based in London’s Docklands and employs around 900 people, but Brussels has already begun the contest to find a new home for the agency, with cities including Dublin and Lisbon in the running.

T he developments come after the EU’s regulatory body for financial firms, the Paris-based European Securities and Markets Authority (ESMA), also set out stringent conditions for UK-based firms wanting to maintain the ability to service clients in the EU.

The EMA did not immediately reply to a request for comment.


Last Updated on: July 3rd, 2018 at 10:37 am, by


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