As if the painful process of extricating the United Kingdom from the European Union was not sufficiently perilous, it appears that it could have a profound impact on the nation’s medical device supply chain. If there is no deal by the deadline of March 2019, the UK may find itself deprived of life-saving medications and devices. The livelihood of its medical device industry could also be in jeopardy.
The Chair of the UK’s Medicines and Healthcare Products Regulatory Agency, Sir Michael Rawlins, told the Independent that millions of diabetes patients, including Prime Minister Theresa May, could be “seriously disadvantaged” if supplies of insulin are affected by a no-deal Brexit. The UK imports “every drop” of insulin, a vital medication used by some 3.7 million people to manage the chronic condition, he said.
Amid the uncertainty, Health Secretary Matt Hancock has announced that the government is drafting plans to stockpile medicine and blood supplies in the event that a deal is not reached with the European Union by the March deadline.
Even if the UK and EU come to some sort of agreement by March, Cook Medical has warned that it may struggle to export medical products from its facility in Limerick, Ireland, to the UK. The medical device OEM, which is headquartered in Bloomington, IN, is calling for an extension to the transition agreement for medical devices until at least 2025 to meet new UK regulatory requirements, reports the Irish Times.
Emmet Devereux, Cook’s Director of Government and Regulatory Affairs for Europe, the Middle East and Africa, said medical device makers have effectively traded without restriction in the UK, but will now have to contend with different rules for importing and exporting components and products, according to the Irish Times. This would have a considerable impact on small to medium-sized device manufacturers, he added, who would need to allocate additional resources to seeking regulatory approval in the UK as well as the markets they currently deal in.
Speaking with Verdict Medical Devices, Jonathan Evans, Communications Manager of the Association of British HealthTech Industries, noted that the “EU is the UK’s biggest export market for health technologies, with around £2 billion worth of goods sent to our European neighbours each year. On the flip side, of the £5 billion total imported health tech used by our health system, £3.2 billion comes directly from the EU and our reliance on this source, as a country, has also increased by 20% in recent years.” He added that 62% of all imported health tech used in the National Health Service comes directly from the EU and many of these products are delivered just in time. “Any delay to supplies could have a very real impact on patients. Of course, nobody wants this to happen and we are confident that sensible, pragmatic solutions will be in place on day one,” he told the media organization.
As things currently stand, however, pragmatism seems out of reach. “[Prime minister] May's newly published Brexit blueprint—known as the Chequers proposals—was received badly by the pro- and anti-Brexit wings of her party and is also likely to be rejected by Brussels,” writes BusinessInsider. “The prime minister would also struggle to push a much softer or harder form of Brexit through parliament, however, leading some to believe that a no-deal scenario has become a highly realistic one,” it adds.