The Conservatives won their overwhelming election victory on a pledge to “get Brexit done”: to leave the European Union by the end of next month. But from the point of view of real changes that will affect medicines, staff and science, January 31st will actually be when Brexit begins. After nearly three years of getting in position, the EU and UK will set out to tear up and replace crucial roles and relationships over a period that will be limited by British law to 11 months.
Move fast and Brexit
Covering many more issues in less time will mean major decisions get taken very quickly.
Under the new Withdrawal Agreement, the transition period – where things stay the same until the end of 2020 – can only be extended if done so by the start of July. So within five months of leaving, we will need to decide whether to run the real risk of leaving without a trade deal at the end of the year. This would not be entirely the same as the total no deal the NHS planned for so extensively last year. The rights of migrant patients and staff already here would be secured, as would the ability of British migrants abroad to keep receiving health care under EU schemes.
However, the disruption to medicines and medical devices would be almost as severe. There would be little to soften the extra costs that could top £2 billion a year across the UK, and outright shortages and stockpiling would be back on the agenda.
Terms of trade
Even with a deal, we can expect changes here to be dramatic.
Medicines in the UK, especially cutting edge ones, have until now been approved at an EU level by the European Medicines Agency. This brings the benefits of being part of a top priority market for new drugs, sharing safety data, and smoothing regulatory burdens and costs. But the fairly basic free trade agreement for which we appear to be on course is very unlikely to continue this. The UK will need to think about how it remains an attractive place to sell medicines – while still holding prices low for the NHS.
In other ways, future agreements could maintain the smoother access to medicines and devices that EU membership has secured – as long as we have the time and political focus to add them. For example, the EU reached agreement with Australia to recognise each other’s approvals of medical devices, and agreement with America to recognise each other’s inspections of medicine manufacturing.
Measures like this will make the difference between something still close to no deal, and a smoother relationship that still likely mean higher costs, but to the tune of hundreds of millions rather than billions, as I calculated for a free trade arrangement under Theresa May’s deal.
Again the decision point will come very quickly. The EU and UK will both need to lay out negotiating mandates in the next two or three months. If these do not contain measures on medicines and devices, it seems unlikely there will be much room to push them back onto the hectic agenda by the end of the year.
The boundaries of science
Unless agreements are in place to stitch things back together, Brexit will also mean being disconnected from institutions and rules that link up science and knowledge across the continent.
There are plenty of precedents for the UK having continued associate membership of the EU’s flagship science programme, and getting itself designated as “adequate” for data protection so that information can still flow freely.
The concern must be that these are exactly the sort of issues, away from the main theme of trade, which might get lost in the race for what the Institute for Government calls a “narrow and shallow” agreement.
The big picture
The wider provisions of a Brexit agreement could also have profound implications for health and health care. The EU are expected to push for a “level playing field” to hold the UK to certain regulations. If it resembles the version nested in Theresa May’s agreement, this could mean that the Working Time Directive, which has had such a powerful effect on medicine, is locked in place permanently. There may also be commitments on public procurement, which is specifically mentioned in the declaration setting out the overall direction of a planned trade deal. These could cut across NHS England’s legislative plans to weaken requirements to put contracts out to tender.
Meanwhile, the shift to the fabled points-based migration system in just a year’s time means the impending risk of a sharp slowdown in incoming staff, just as shortages reach a crescendo. With social care funding reform on the backburner, the need for migrant staff here will be even more prolonged than anticipated.
The NHS’s experience of Brexit has so far been dominated by planning for no deal. This will need to continue. But the sector also needs to lift up its head, now, and start explaining what it wants to see in a deal, and in the world afterwards. Brexit is about to finally get off the start line, and it will accelerate fast.
Dayan M (2019) “The NHS will now need to get Brexit begun”, Nuffield Trust comment.