A US medical device-maker with a significant employee base in Limerick has warned that it may struggle to export products from Ireland to the UK from 2020 unless a transition agreement for medical devices is extended.
Cook Medical, which employs more than 850 people in Limerick, called for the agreement to be extended until at least 2025 to allow the medical technology sector enough time to meet new UK regulatory arrangements and ensure patients do not experience delays in product delivery.
While the company did not suggest its Limerick employee base or revenues would be affected, it did say UK patients would likely suffer under the existing timeline.
Emmet Devereux, Cook's director of government and regulatory affairs for Europe, the Middle East and Africa, said the various 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.
He flagged that small to medium device-makers in particular could suffer, having to allocate additional resources to seeking regulatory approval in the UK as well as the markets they currently deal in.
“A larger company like ours would have to put significant global resources on to this. Smaller companies wouldn’t have resources to do this,” he said.
Components
One such device that may not be able to be exported immediately after 2020 is a drug-eluting stent, a device that slowly releases a drug into narrowed, diseased arteries. That device has "two critical components", according to Mr Devereux, both of which would require separate approvals.
While not necessarily troubling its Irish operations, it will have a negative affect on the company’s clients.
The UK's National Health Service (NHS), Mr Devereux said, imported £5 billion worth of medical devices and exported only £2 billion.
“Considering the importance of medtech to the Irish economy, we believe it is not only in the industry’s best interests, but ultimately in the interests of patients that the transition agreement is extended to avoid disruption to an integral part of the national economy.”
Contact lenses
Cook Medical highlighted that the industry employs over 38,000 people in the Republic and generates approximately 10 per cent of all Irish exports, worth €12.6 billion to the economy. For example, a third of the world’s contact lenses and a quarter of its diabetes injection devices are manufactured in the State.
Although important to the Republic’s economy, the UK as an export market is not quite as significant for larger medical device players with Irish manufacturing bases. These firm export around €300 million to the UK from Ireland.
Aside from stents, Cook manufactures a significant range of products including catheters and items used for dialysis. The European market as a whole is estimated to be worth €100 billion to the medical device sector, around €13 billion of which is accounted for by device-makers in Ireland.
