The US is ready and waiting to take advantage of the huge opportunities arising from the unique political and regulatory circumstances impacting the UK medtech sector. That was the message from Yvonne Puig, head of life sciences and health care at the US offices law firm Norton Rose Fulbright, in her keynote address at an Association of British Healthcare Industries (ABHI) meeting October 5.
Speaking to delegates at the ABHI conference, she said: "While you are struggling … we are watching you … with a lens of opportunity."
The US is "hoping more UK innovators will come to the US and invest in the US as a safe harbor from other regulatory guidance and restrictions that may be posed as a result of the [EU Medical Device Regulation.]"
The US is "hoping more UK innovators will come to the US and invest in the US as a safe harbor from other regulatory guidance and restrictions that may be posed as a result of the MDR," attorney Puig says.
The disruptive circumstances brought about by the hugely complex MDR, combined with Brexit and the pro-business and anti-regulation Trump administration, has brought unique opportunities for a closer relationship between UK medtech firms and the US, Puig noted.
Innovators are already facing more incentive to enter the US before the EU now, Medtech Insightnotes, because of the increasingly stringent clinical data guidance in the EU that pre-empts the new, yet-to-be-enforced regulations. Some member states appear to be imposing on the clinical data expectations on their industries.
"The UK has no better friend than the US when it comes to technology and innovation… We are hungry to place our products in your market and we know there is a pent-up demand and hunger for you to place your products and innovation in the US," Puig said.
She also noted that the message being sent by the UK post-Brexit is that the UK is entering a period of self-governance and wants to negotiate new trade agreements.
This is a huge opportunity from a US perspective, Puig said, adding that this is the time to forge those relationships – while there is still some uncertainty.
UK Medtech: Between A Rock And A Hard Place?
Puig was speaking to some 200-plus medtech regulatory specialists, a large proportion of whom were UK citizens who had voted to stay in Europe and who have considerable reservations about President Trump.
Trump is telling the US government to get rid of two regulations for every one brought in, Puig told the meeting. And some in the FDA are spending more time, she said, "reviewing how to best to satisfy the one-in two-out rule than they are on other deeper and more important health and safety and regulatory issues."
Against this background, it is hard to see how the established UK medtech industry would square the potential ethical issues around this US-style deregulation initiative with its own record on health and safety "to invest in the US as a safe harbor from other regulatory guidance and restrictions that may be posed as a result of MDR."
Indeed, despite the huge complexity of the new EU regulations and the struggle for companies to find sufficient resources to implement it, the UK medtech industry (supported by MedTech Europe) is actively campaigning for the UK government to fully implement the new EU Medical Device and IVD Regulations, which it firmly believes are critical for patient safety.
But if the government does not allow this – and many believe it will not, because of the timing problems with implementation of the regulation itself, plus the many delegated and implementing acts that will not be ready until well after the UK has left the EU – then what alternative regulatory route will UK be following?
Will any trade relationship with the US influence this choice? Might the UK be lured by less stringent regulation? And if it is, what might that mean in terms of trading with the then EU 27?