Medical technology companies who wish to do business in the UK currently have a lot on their minds. Revolutionary regulatory changes, restructured National Health Service (NHS) services, new procurement avenues and, of course, preparing for the UK’s departure from the European Union (EU) are all making planning for the long term quite a challenge in 2017.
First and foremost, the new European Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR) are currently a primary concern for the industry. “Brexit uncertainty” is a familiar phrase throughout boardrooms across the UK and beyond, but the medtech industry has faced an extra dose of upheaval in the shape of the new MDR/IVDR—consisting of over 200 articles across more than 1,000 pages—that officially came into force across the EU on 25 May. Despite the presence of a three-to-five year transition period (depending on the technology in question) to adjust to these long-awaited changes, the stricter requirements and a lack of “grandfathering” means this is a daunting change to business for many companies.
As the industry adjusts to the new regulations and awaits developments following the commencement of Brexit negotiations, a clear political settlement domestically would have brought a welcome degree of stability over the next five years. This proved not to be the case, however, and though the governing party is ostensibly the same as before June 8th, the reality is that the future for business has become significantly less clear.
The impact of this result goes beyond Brexit. One of the most significant complaints from medtech companies is that while the UK is an excellent hub for research and development, the NHS is poor at adopting such innovation, particularly at a pace that allows patients to have access to the most cutting-edge technologies on the market. Indeed, many companies often look abroad if they want a novel technology to be taken up rapidly. As such, initiatives such as the Accelerated Access Review (AAR), which aims to speed up access to new drugs and technologies, and the Life Sciences Industrial Strategy were welcome endeavours. For programmes such as these that already sit in the all-encompassing shadow of Brexit, however, the election result will likely now delay them further. The government response to the AAR, which itself was delayed for many months, will almost certainly not come over the summer as originally expected and work on the Life Sciences Industrial Strategy will also surely stall.
Given the operational independence of the NHS, the election result will likely have less of an impact on their work towards delivering the aims of the Five Year Forward View, which outlines how the health service needs to change to cope with the myriad pressures it is currently facing. Given the lack of much political room for manoeuvre, however, controversial programmes such as the Sustainability and Transformation Partnerships and other changes that can be painted as NHS cuts are more likely to make previously comfortable politicians pause for thought.
Finally, the joker in the pack is Northern Ireland’s Democratic Unionist Party (DUP)—the unexpected kingmakers of this election, as the Conservative Party attempt to agree to a deal that will keep them in Government—who will have their own priorities. What their role will be and how significant an impact they will have on Government policy remains to be seen, but it is yet another unknown that has now been thrown into the mix.
The one hope for the medtech sector is that this result will actually make the chances of a transitional period following the UK’s departure from the EU, which industry has wanted all along, more likely as the Government takes the time to compromise in order to get legislation passed. Furthermore, the DUP are on record as opposing a hard border with the Republic of Ireland and are thought to be wary of a “hard Brexit,” which could be an important factor in any deal that is struck between the Conservatives and the DUP.
This only remains relevant as long as a Conservative minority government remains in power, however. We still face the very real possibility of a Conservative leadership contest and second General Election later this year. Rather than give stability, with Brexit negotiations now underway, the election has made the political future of the UK even less clear. The medical technology industry may just have to accept that uncertainty is the new normal.