The UK’s surprise decision to leave the EU has caused a great deal of uncertainty about the country’s future, not least among those working in the UK biopharmaceutical and broader life sciences industry.
As a sector that is subject to a high degree of EU-level regulation, the life sciences are likely to feel the effects of a Brexit more acutely than other less regulated industries. Exactly what these effects will be is difficult to say with any certainty because the UK government is still weighing its options before triggering exit negotiations under Article 50, a move that is not now expected until well into 2017.
Until that happens – and maybe for many years after that – we will not know exactly what kind of relationship the UK will eventually have with the 27-country bloc or how far it will have access to the EU single market.
Some predictions, though, can be made with a fair degree of confidence. The European Medicines Agency will most probably have to relocate from its current premises in London to another EU member state, with all that implies for pharma firms, experts, patients, EMA staff and the EU drug regulatory network as a whole.
The UK is likely to miss out on the benefits of the new, more streamlined clinical trial regulatory framework that will emerge when the EU Clinical Trial Regulation comes into effect in 2018. It will also find itself outside Europe’s new unitary patent and Unified Patent Court system, in which it was to have played a key part.
There are fears, too, that UK pharmaceutical and medical device legislation will gradually fall out of step with that of the EU, that UK scientists will lose access to European funding networks and key research projects such as Horizon 2020, and that limits on freedom of movement could impact company recruitment and other strategies.
These and many other issues raised by the referendum result are analyzed in detail in “Brexit And The Life Sciences: What Lies Ahead?” – a new report from Informa Pharma intelligence.
Gathering together news stories and analysis from writers on Scrip Intelligence, The Pink Sheet and Medtech Insights, together with contributions from outside experts, the report covers the period from May 2015, when former prime minister David Cameron got the go-ahead to hold a referendum on EU membership, all the way through to the June 23, 2016 vote and its aftermath, including actions now being taken by industry to help steer the sector through the coming turmoil.
It examines pre-vote warnings from industry associations and the likes of AstraZeneca, Bayer and GlaxoSmithKline about the effects of Brexit uncertainty on R&D activity and inward investment, and the fears that have been raised over a diminution of the role and influence of the UK regulator, the MHRA.
It looks at the likely effects on the UK’s participation in European multicenter clinical trials, what’s to be done about the validity of existing and future centralized EU approvals in the UK, and how Brexit could deal a blow to UK life science leadership. Also covered in the report are the implications for medical device companies, notified bodies and authorized representatives, and whether the new EU regulations on medical devices and in vitro diagnostics will ever take effect in the UK.
Two months on from the momentous vote, there are concerns on the regulatory front that the relocation of the EMA could lead to recruitment problems and a brain drain. And some have cautioned that the government’s Brexit talks will need to prioritize continued patient access to new medicines while avoiding future divergence among the regulatory systems of the UK and the EU.
From the industry point of view, though, the report suggests that a more positive attitude is emerging. While Brexit will leave five of the top six European pharmaceutical companies domiciled outside the EU, some major companies have stressed their continued strong commitment to the UK, and pointing out that for now it is – more or less – business as usual.
And in order to ensure that the sector’s priorities are included in the government’s negotiating position with the EU, leading biopharmaceutical organizations have established the “UK/EU Life Sciences Transition Program” spearheaded by an industry-government Life Science Steering Group that will look at all the issues raised by Brexit and draw up a set of recommendations for paving the way forward.
The ultimate aim of this initiative, the report notes, is to foster the development of a world-leading life sciences environment in the UK. And if suggestions by GSK’s CEO Sir Andrew Witty are anything to go by, it could also result in a new kind of MHRA that will be a “best-in-class” agency equal to the challenges posed by a UK that in a few years’ time will no longer be a member of the European Union.
3 The Early Days
8 The Brexit Stakes
15 Business Speaks Out For Remain
20 The Effects On Research, Science, and Clinical Trails
32 The Vote and Its Aftermath
40 The Business Outlook – Not So Bad After All?
54 Problems For The EMA And The Regulatory Network
61 Where Next For IP And The Future Of Patent Court?
65 Effects On The Medtech Industry
74 The View From Abroad
79 What Does Industry Do Now?
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