What do medical devices tell us about the problems of Brexit?
You probably don’t wake up at night worrying about the future of medical devices regulation (e.g. ventilators or heart monitors – and any product or equipment intended for medical use). But it’s one of the latest examples of the contradictions of Brexit – and especially how a subjectively pro-business agenda often struggles to win the backing of businesses.
The UK government has declined to implement the EU’s new Medical Devices Regulation, which came into force on 26 May this year. After a series of scandals over breast implants, surgical meshes, and defibrillators, the new EU legislations aims to toughen up rules on medical devices – bringing them more into line with the pharmaceutical products by requiring companies to prove that they are safe and deliver benefits to the patient.
Instead of backing the EU rules, the UK is seeking to create a lighter touch, bespoke system that the government claims will favour ‘innovation’. So, you might expect industry to support the proposals, against the new demands for oversight from the EU. But this isn’t actually the case. Businesses have spoken out against diverging from European rules.
Kevin Kiely, the chief executive of Medilink UK, who represent 1,300 small businesses making medical devices, argued they were simply too dependent on exporting to the EU:
“The reality is that we’ve got to sell into Europe, so all companies have to comply with MDR anyway. The last thing they need is yet another audit trail that duplicates what they already have to do in Europe.”
This encapsulates many of the problems of Brexit on three levels.
First, even if you accept that there is a strong case for deregulation (we don’t at Brexit Spotlight), in its own terms this is unlikely to offset the losses of diverging from the European market. Like most small manufacturing companies, with often tight margins, exporting to the huge market on the doorstep is essential for survival – not an optional extra. Globally, the big trend setters in regulation are the US and EU – because they have huge internal markets this gives them clout to set rules, which the UK can’t compete with.
Second, by pursuing lighter touch regulation, the UK government prioritises the interests of ‘bad capital’ over more socially responsible companies. The UK’s refusal to implement regulation designed to improve standards across the whole sector may simply attract medical businesses that are producing lower quality and potentially unsafe products.
Third, the proposals are out for consultation and, given these problems, it may well still be the case that the UK adopts regulations that are very similar to the EU but maintain a formal regulatory divergence. As discussed in the Another Europe Is Possible report on the Brexit deal and its problems, in a range of different areas the UK appears to be establishing pointless new regulatory structures, even though the rules and standards haven’t changed.
So, the government is caught in the contradictions of the original ‘buccaneering’ Brexit vision. It’s a business case for deregulation that lacks the support of most businesses.
August 4, 2021
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