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ABHI Guest Blogs with Paul Bristow: Brexit Showdown

The Brexit process rumbles on, yet we are seemingly no closer to answering fundamental questions such as ‘what will medical device regulation look like?’ Recently we have seen both pro and remain groups attempting to force Theresa May’s hand.

First of all, we saw a group of 60 pro-Brexit Conservative MPs send a letter to the Prime Minister setting out what they want from the Brexit process. Demands included freedom for the UK to start negotiating trade deals with non-EU partners straight away and full regulatory autonomy. The message from the group, which includes former Ministers Iain Duncan Smith and Priti Patel, as well as grassroots favourite Jacob Rees-Mogg, was clear, we do not want the kind of alignment with Europe currently being floated by some Cabinet Ministers.

This was followed by Jeremy Corbyn providing some long-needed clarity on Labour’s position. In a speech on Monday he said that Labour would support the UK remaining in a customs union. Whilst this might not be exactly what "Remainers" had been desperately longing for, it does give clarity on Labour’s position and provides a stark contrast with the hard "Brexiters" on the right of the Conservative party.

The key question is – where does this leave Theresa May? Perhaps more importantly, does any of this matter? The answer to that question is yes. The European Union (Withdrawal) Bill is currently at Committee Stage in the House of Lords. Which means it will not be too long before the Bill comes back to the Commons for consideration of any amendments made by the Lords. The government has already pushed back crucial votes on the Taxation (Cross-Border Trade) Bill, to avoid defeat after Ken Clarke and Anna Soubry put forward amendments that would keep Britain in a customs union with the EU.

This leaves the Prime Minister in a tricky position, the right of her own party is growing increasingly demanding, as Labour’s position firms up and starts to form some real opposition on the Brexit issue. All this leads Mrs May to have to weigh up some tricky Westminster arithmetic - which side is most likely to cause her defeat in any Commons vote? Given the divisions in both parties on the issue, she will have to think long and hard about which side she can make concessions to.

Whilst all this high politics is played out in the tea rooms of Westminster, a key question remains for the HealthTech industry: what does the future hold for medical device regulation? The Withdrawal Bill is clear – the UK will transpose any legislation currently in place or scheduled to be in place by March 2019. It is not clear, however, what this means for the Medical Device Regulation (MDR) process, with much secondary legislation still to be agreed and unlikely to be completed by March next year. Ministers are yet to provide any certainties on this question. PBC and ABHI will be working over the coming weeks to seek clarity on this issue.

 Paul Bristow is the Managing Director of PB Consulting: a specialist public affairs and consultancy service.