After months of passionate campaigning and an incredibly tight race, the UK voted to leave the European Union in a referendum held on 23 June.
Before the vote, the pharma, life science and healthcare sectors all threw their support behind the Remain campaign, stressing the importance of the EU market to their businesses and workforces, and in the immediate aftermath they reiterated that a lot of difficult questions will need to be addressed in the near future.
Mike Thompson, chief executive of the ABPI, said the decision “creates immediate challenges for future investment, research and jobs in our industry in the UK”, but added that the Association is “committed to working closely with the government to agree what steps need to be taken to send a strong signal that the UK is open for business”. Steve Bates, chief executive of the BioIndustry Association, said that while the fundamentals of UK bioscience remain strong, “several key issues for our sector are now in flux”. “Key questions about the regulation of medicine, access to the single market and talent, intellectual property and the precise nature of the future relationship of the UK with Europe are now upon us. This will require detailed and dispassionate thinking and the BIA will make its and its members’ expertise available to the government and its key agencies in the coming weeks and months as we work through these complex issues.”
Sarah Hanson, head of UK Life Sciences at international law firm CMS, said: “We must consider the referendum’s effect on the significant body of EU legislation which governs the development and supply of medicines and medical devices. Companies engaging in any way with the European Economic Area (EEA) markets will face increased regulatory burdens from having to deal with separate UK and EU regulation, so the industry faces an arduous job ahead.”
One major regulatory issue is that the European Medicines Agency (EMA) is likely to be forced to move out of London and the UK will no longer be able to use it as its main regulatory body. Sweden and Ireland are among the countries lobbying to be its new home. Meanwhile, the MRHA has been mooted as a potential replacement regulator for the UK.
The UK could also lose its position as the EU’s most popular location for phase I trials, and researchers in the country will no longer be eligible to apply for EU grants or participate in EU-wide projects.
Meanwhile, in a statement, the European Federation of Pharmaceutical Industries and Associations (EFPIA) stressed the importance of ensuring that the patient is at the centre of all subsequent decisions.
“EFPIA shares the common goal of ensuring rapid access to innovative medicines for patients across Europe, as well developing a regulatory and policy environment that fosters innovation and supports the research and development of new medicines to meet the needs of patients, healthcare systems and society. As an industry, over the coming months, we are committed to engaging with stakeholders both in Europe and in the UK to support these objectives.”
But six months on, there is still almost no clarity on what Brexit will mean for the industry, or even the UK as a whole, going forward. This is likely to be the case at least until the formal process of leaving the EU begins (by activating Article 50 of the Lisbon Treaty). The government is hoping that this will happen by March 2017, but some commentators have said that this is unrealistic now that the High Court has ruled that the Brexit process can only start after a vote in parliament.
Nevertheless, with the decision setting in pundits have started to moot what pharma companies could do to avoid too much damage – such as a hoping for ‘soft’ Brexit where the UK remains part of the EEA, or even relocating headquarters to mainland Europe. A new UK EU Life Sciences Steering Group is working with stakeholders across the industry; it aims to secure regulatory co-operation with Europe, predictable funding and collaboration for scientific research, access to the best talent, and the ability to trade and move goods and capital across borders.
These fears have not been confined to pharma though – many commentators have pointed out that the NHS is likely to face many challenges, particularly in terms of recruitment. According to the Health & Social Care Information Centre, the health service currently employs 9,814 doctors (8 percent of the total) and 18,783 nurses and health workers (6 percent) who come from other EU countries. Although they are unlikely to be forced to leave the UK, there are fears that some will choose to go anyway and the supply of new recruits will thin. In the meantime, higher recruitment costs and an increased reliance on agency staff would add to the NHS wage bill, exacerbating the squeeze on funding. This could in turn mean that pharma will bear much of the pressure for pricing cuts.
Political turmoil also followed the vote, with PM David Cameron, who had campaigned for Remain, resigning almost immediately, paving the way for former home secretary Theresa May to take his place. With a new cabinet in place the UK life science sector could well have to deal with wider policy changes over the next few years.
