European Medicines Agency set to leave London post-Brexit
Bidding has started to find a new home for the European Medical Agency (EMA) which employs 900 people at its London HQ, says Dods Monitoring Consultant, Bruce Reilly.
Like a pharmaceutical Olympic Games, bidding has begun to become the next host city for the European Medicines Agency (EMA), the EU's regulator for treatments across the European Economic Area.
Despite David Davis' assertions that the EMA could remain in London post-Brexit, it is all but certain that the UK will leave the regulatory system and the Agency will leave the UK after 2019. What does this mean for the future of the UK's pharmaceutical & life sciences sector and how is the industry responding to the challenges ahead?
The importance of the sector to the UK's economy is almost universally agreed on, with the Prime Minister saying in 2016 “it is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry”. What is also agreed on is the risks that Brexit poses to medicines regulation, research collaboration, the workforce and access to new treatments.
The EMA's headquarters in London bring with it almost 900 jobs and wider economic benefits to the pharmaceutical sector. The UK's Medicines and Healthcare Regulation Agency carries out almost a third of the EMA's work alone, so its absence would be hard felt in the industry. The EMA has already begun planning for the division of the UK’s share of its workload on the assumption it will no longer be available to pitch in.
Almost every European capital is jockeying for position to become the next seat of the EMA. The head of the Agency, Guido Rasi, has maintained a neutral stance on the decision, which will be made collectively by all member states.
However, the future of the UK's relationship with the EMA will be far more important than its location. If the Government were to remove itself completely from the EMA's centralised approval process, would global pharmaceutical firms deprioritise access to the UK market if it means they must endure the burden of a separate approval process? This scenario raises the potential for delayed access to new treatments for UK patients.
The Government has been vague on its intentions, with Jeremy Hunt saying little, other than expressing his wish to "work very closely" with the Agency. The trade body the Association of the British Pharmaceutical Industry (ABPI) has called for an aligned regulatory regime "from day one".
The sector has also expressed concern over attracting and retaining the skilled workforce that is the backbone of its success. The Welcome Trust, one of the world's largest medical research charities, has called on the next Government to ensure "openness" to global talent.
Wider collaboration with the EU on research and its funding in the future is still not entirely clear, although the Government has promised to underwrite any Horizon 2020 grants for projects that continue after Brexit.
The recent passage of the Health Service Medical Supplies (Costs) Act became a lightning rod of sorts for concerns over the industry. The Act's main aim was to update the Government's powers on controlling the cost of drugs, but opposition Peers attempted to amend the legislation to ensure the Government "took account" of the needs of the life sciences sector when exercising its duties. It is clear politicians of all parties are willing to defend the wider economic interests of pharmaceutical and life sciences firms when they are seen to be at risk.
However, that's not to say the sector is despairing completely at the thought of Brexit. Recent months have seen continued investment from pharmaceutical firms and the industry remains relatively bullish about the prospects for the future, given the 'right' approach from the Government. The ABPI recently claimed we were "in a golden age of new medicines" and the much-anticipated response to the Accelerated Access Review should provide benefits for researchers, regulators and patients alike.
So, the life sciences and pharmaceutical sector will continue to press their case as they wait for further clarity on the Government’s approach to Brexit, medicines regulation and the Industrial Strategy. Whilst the challenges the sector could face as a result of Brexit did not feature prominently during the 2016 referendum, you can be sure the Prime Minister cannot afford to ignore them now.
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