Brexit and the Life Sciences – Are We Heading for Chaos?

[fa icon="calendar"] Wed, May 18, 2016 / by Alexandre Alain

As Britain prepares for its referendum on leaving the EU, business leaders in the life sciences are already counting the cost of Brexit

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Britain’s Brexit referendum is weeks away, and polls have consistently suggested the result is too close to call

The implications for Brexit and the life sciences are so far-reaching that uncertainty is already creating ripples

Hiring and investment expectations at C-level across industries are at a three-year low, according to the Financial Times. The cost of protecting against a plunge in the value of sterling has soared, and the pound recently hit a seven-year low because of uncertainty over Brexit. 

This climate of caution has created widespread concern in a sector already balancing regulatory complexities, demand for innovation and challenging market conditions. 

Fears about Brexit and the life sciences are understandably focused on changes to regulatory

processes. The confines of EU policy may frustrate many, but for the life sciences – and particularly the pharma industry – harmonization is a key benefit. 

Brexit could bring chaos to the life sciences as Britain will be faced with redesigning the whole authorizations process of bringing medicines to market. 

Steve Bates, CEO of the BIA recently outlined his fears, hinting that a whole new set of regulations for the UK would prove a major turn-off for pharma giants, risking delays, excessive bureaucracy, higher costs and widespread disruption. 

He said: "The BIA believes that the UK is the most attractive destination in Europe for life science companies as we attract a third of the innovation capital to Britain and we are the HQ of choice for many US companies looking to enter the European market – something made possible by having access to a single market.” 

Major players in the life sciences agree. Without Europe, Britain suddenly looks quite vulnerable. The UK represents just 3% of the total global pharmaceuticals market. 

In examining the fallout from Brexit, life science leaders have also been keen to flag up the implications for drug discovery, rather than sales. 

Leaving the EU would directly affect scientists’ funding, putting clinical trials and the bringing of new drugs to market at risk. Remaining in the EU secures Britain’s involvement in pan-European collaborations in R&D and, of course, access to the EU marketplace – with a GDP of around $18 billion. 

The biggest question mark is over the relocation of the European Medicines Agency (EMA) – currently based in London. 

A British Government briefing paper on Brexit outlines hopes for continuing relations with the EMA post-exit, because provision for centralized marketing authorization already extends to Norway, Iceland and Lichtenstein. But the paper warns: “If this were not the case, however, pharmaceutical companies might need to apply for marketing authorisations separately to the MHRA for every medicine they wished to supply in the UK.” 

Brexit could further complicate the marketing status of new drugs and place prescription drugs in regulatory limbo

Industry commentators predict that the EMA will leave London and set up elsewhere in Europe. 

Restrictions on freedom of movement post-Brexit could also threaten the UK’s position as a global talent pool for the life sciences. Britain is the headquarters for some of the world’s leading research bodies, at least ten of which are located in the Golden Triangle of Oxford, Cambridge and London. 

Britain currently enjoys an elevated status and is thought to currently get more back than what it pays in, in terms of EU research funding. British universities are at the helm of the EU’s Horizon 2020 project. Brexit could place £8.5 billion of EU funding under threat, and weaken the UK’s international standing. 

The European Federation for Pharmaceutical Industries and Associations (EFPIA) recently stated: “Brexit has the potential to impact on regulation, the status of the EMA, finance, employment, the transfer of personal data and the European research ecosystem.” 

The BioIndustry Association (BIA) has also cautioned against Brexit. An editorial signed by more than 50 executives declared: ““Not only would an exit from the EU negatively impact on the life sciences sector, but changing the current arrangement would lead to disruption, expense, and significant regulatory burdens for a new authorisation system.”

Risk managers in the life sciences need to plan carefully for the impact of Brexit, and strategies should encompass regulatory change and the market destabilization already occurring due to widespread uncertainty.

Takeaways

  • Planning for Brexit starts now, not after the result of the referendum.
  • The impact, though hard to predict, centers on changes to regulation, funding issues and freedom of movement.
  • Risk management strategy around Brexit should go beyond the reactive.
  • Supply chains need to be strengthened now.
  • Future proofing should take in different post-exit models.

Prepare for Brexit now and learn more about managing risk. Download: Beat the Regulator - Proactive Risk Management in the Life Sciences

Beat the Regulator - Proactive Risk Management in the Life Sciences

Topics: Europe

Alexandre Alain

Written by Alexandre Alain

Life Science Product Manager

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