The pace of Brexit-related work that impacts the UK medtech industry shows no sign of slowing over the summer. In view of unexpected – uncomfortable for some – recent opinion poll findings, there is unlikely to be a significant change in somewhat febrile UK atmosphere anytime soon. And the future UK medtech regulatory situation still needs close attention.
UK "Brexit secretary" David Davis met his EU counterparts for the second round of withdrawal talks this week in Brussels. No one expected great progress from the sessions, but few could have expected so little. It's an indication that the UK government is increasingly unhappy in its own skin and is newly beset by Brexit uncertainties of the kind that it inflicted on the country at large with such apparent alacrity just a year ago.
If a UK election were held today, 45% of the electorate would vote for the current opposition, leaving the ruling Conservatives trailing at 40%, according to the July 10-11 YouGov poll. UK BioIndustry Association (BIA) Chief Executive Steve Bates told his monthly Brexit webinar audience (July 19) that the government's implausible post-election weakness has meant that many positions on EU withdrawal – on "hard" Brexit especially – have moved a lot in the past month. Brexit, it seems, is not a "done deal" and the government is engaging with industry in a new way, as PB Consulting's Paul Bristow observed during the Association of British Healthcare Industries' recent Brexit Question Time (June 28). (Also see "UK Medtech One Year Post-Brexit Vote: Still In The Land Of Uncertainty" - Medtech Insight, 30 Jun, 2017.)
Bates also mentioned that applications to host the European Medicines Agency, currently headquartered in London, must be in by July 31, and a decision will be made during or after the EU General Affairs Council meeting of November 14-15. The BIA was evidently gratified by the flurry of open letters published in the Financial Times in recent weeks showing that the UK health ministry and life sciences industries want to retain a close relationship with the EU in matters of regulation.
The inaugural meeting of the NHS Confederation's Brexit Health Alliance, held yesterday (July 19), was largely an organizational affair that will be followed up at three-monthly intervals. Detail from the meeting will emerge next week. The Alliance, announced in mid-June, aims to bring together 14 stakeholders, including the NHS, medical research, industry, patients and public health organizations. It is overseen by co-chairs Sir Hugh Taylor, former permanent secretary Department of Health, and Niall Dixon, chief executive of the NHS Confederation.
UK Must Be Alive To MDR/IVDR Adoption Scenarios
Testifying to the volume of activity in June and July, Alison Dennis, a partner with law firm FieldFisher, wrote in the ABHI's Brexit blog (July 19) that the publication of the so-called "Great Repeal Bill" on July 13 will, when enacted into UK law, deftly sweep EU laws onto the UK statute book as UK laws – but it won't be all plain sailing.
A potential problem arises with the EU Medical Device and IVD Regulations, which will become directly effective in EU member states as of the dates that the different provisions come into force, Dennis writes. Most of the provisions will be enacted after the UK's scheduled departure date (March 29, 2019 – unless extended). Thus, the UK will have to proactively take steps to separately enact the provisions of the two regulations into UK law. If it doesn't, the by-then outdated trio of EU Directives (Medical Devices Directive, Active Implantable Medical Devices Directive and IVD Directive), converted into UK law, will have primacy in the UK.
Concerned at this potentially disastrous course of events, Dennis has taken time to explain the situation to UK junior health minister Lord O'Shaughnessy (who recently delighted industry with Accelerated Access Review – AAR – funding pledges (Also see "UK Device, IVD Sector Cheered By New Funding Pledge For Accelerated Access Program" - Medtech Insight, 14 Jul, 2017.)). She said she impressed upon him the need to be alert to the risk of this major backwards step for UK medical device regulation.
ABHI Follow-up Survey Of Brexit Attitudes
Regulation in the post-EU era is the major Brexit preoccupation for UK based-medtechs, but as delegates learned at the ABHI Question Time panel (which featured legal expert Dennis), there are mixed views on the current significance and impact of Brexit on UK medtech trade after March 2019. ABHI market access director Andrew Davies provided more detail on the June 2017 Brexit survey findings that were reported at last month's ABHI Question Time at a June 29 Westminster Health Forum (WHF) meeting.
Brexit is currently viewed as a top challenge by 53% of UK companies polled (unchanged since 2016), but access to the NHS has become their overriding concern (70%, up from 46% in 2016). A reduced 37% (down from 52% in 2016) say investment decisions are being put on hold, and only one fifth (down from one third) say that commercial opportunities are being delayed. And 60% (up from 30%) have seen increases in manufacturing costs since the June 2016 referendum. On the question of whether companies are seeing increased opportunities to trade outside the EU, 42% (compared to 37% in 2016) say it is still too soon to tell.
Davies told the WHF meeting that the survey shows that there is no clear picture yet on trade post-Brexit, but that there is a lot of cost pressure in the system.
The initial shock of Brexit has been absorbed by UK medtechs, and although the ABHI survey produced a mixed bag of findings, there is a pervading sense of damage limitation, rather than anything approaching confidence. In this busy summer of Brexit positioning, industry awaits the next chapters with nervous anticipation.