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HDA UK Media And Political Bulletin – 7 June 2017

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Drugs regulator admits focusing on ‘worst case scenario’ with Brexit advice
The Telegraph, Iain Withers, 5 June 2017

The European Medicines Agency (EMA) has admitted that its Brexit guidance issued last week, estimating costs to the UK pharma sector of hundreds of millions of pounds, was only a “worst case scenario”. In its guidance, 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. The paper also warned that the UK faced a sharp hike in regulation and stringent checks on medicine exports from March 30, 2019. An EMA spokesperson has since said: “The Q&A document released by the European Commission and EMA provides guidance for marketing authorisation holders on how to prepare for the worst case scenario in order to protect public health and ensure continued availability of good quality, safe and effective medicines.

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Drugs regulator admits focusing on ‘worst case scenario’ with Brexit advice
The Telegraph, Iain Withers, 5 June 2017

The European Union’s drugs regulator has admitted Brexit guidance issued last week that experts warned could cost the UK pharma sector hundreds of millions pounds to implement was only a “worst case scenario”.

The European Medicines Agency (EMA) – one of two prized EU regulatory bodies currently based in the UK that is expected to move to the Continent – issued a paper last week 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.

The paper also warned that the UK faced a sharp hike in regulation and stringent checks on medicine exports from March 30, 2019.

Trade body the Association of the British Pharmaceutical Industry (ABPI), which lobbies for the 60,000-strong sector, criticised the EMA for only outlining one scenario, “the hardest of hard Brexits”. It warned the guidance posed a risk to UK pharma jobs and public health, and would cost “hundreds of millions of pounds” to take up. The EMA has subsequently clarified that the paper was preparation for a “worst case scenario” where no early deal for the pharma sector is struck.

An EMA spokesperson said: “The Q&A document released by the European Commission and EMA provides guidance for marketing authorisation holders on how to prepare for the worst case scenario in order to protect public health and ensure continued availability of good quality, safe and effective medicines.

“Adequate planning and preparation by companies is essential to ensure that all the necessary arrangements can be made in due course to allow for an orderly transition to a medicines regulatory system where the UK is separated from the EU 27.

“If at the end of the UK withdrawal negotiations, other arrangements or temporary arrangements are agreed then the approach will be adapted accordingly.”

The ABPI warned last week the paper highlighted the “critical importance” of politicians, regulators and companies working to strike an early compromise deal.

The EMA is currently based in London’s Docklands and employs around 900 people.

Dr Virginia Acha, executive director of research, medical and innovation at ABPI, said: “[Before Brexit negotiations have even begun] It seems premature to advise companies to prepare only for an outcome where the UK is isolated from the European system.

“Further discussion and guidance will be needed as we seek to ensure that medicines continue to be developed and delivered to patients in the UK and across Europe.”

HDA UK Media And Political Bulletin – 7 June 2017

From Factory to Pharmacy

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