The ongoing lack of an agreement between London and Brussels is a challenge for companies that serve patients both in the UK and the EU.
Cook Medical, which employs more than 850 people in Limerick, has today called on the British Government and the EU to push for an extension of the UK’s Brexit transition agreement for medical devices until at least 2025. The EU has come out strongly that businesses should prepare for a no deal scenario.
Extending the post-Brexit transition period would provide the MedTech and other highly regulated industries with additional time to meet new UK regulatory arrangements and protect supply chain integrity, as well as ensuring patients and customers do not experience delays in product delivery.
“Patient need and wellbeing isn’t at the forefront of conversations about Brexit trade restrictions. The process to acquire regulatory approval for these complex, often life-saving products is intentionally rigorous to protect patients. It will be extremely difficult for MedTech companies to ensure that their products meet any new UK regulatory requirements or frameworks by the end of 2020, as so much remains uncertain and undecided,” said Emmett Devereux, director of government and regulatory affairs EMEA at Cook Medical.
Devereux continued: “Cook Medical, and every other MedTech company that has traded without restriction in the UK and the rest of Europe, will have to contend with different rules for importing and exporting components and products, and rework existing supply chains under Brexit. We strongly believe that Dublin and Brussels should push this transition date to 2025 or agree to an exemption for medical devices and the MedTech industry to ensure that their operations and supply chains remain uninterrupted so that patients remain unaffected.”
Employing over 38,000 people in Ireland, the MedTech industry generates approximately 10 percent of all Irish exports, worth €12.6 billion to the Irish economy. A third of the world’s contact lenses and a quarter of its diabetes injection devices are manufactured in Ireland. MedTech is recognised as one of Ireland’s emerging global industries.
“Considering the importance of MedTech to the Irish economy, we believe it is not only in the industry’s best interests, but it is ultimately in the interests of patients that the transition agreement is extended to avoid disruption to an integral part of the national economy,” said Mr. Devereux.
A bigger role for the HPRA
Cook Medical is also calling for increased Government funding for the HPRA (Health Products Regulatory Authority) as the influence of equivalent UK body MHRA (Medicines & Healthcare products Regulatory Agency) declines in pre-Brexit Brussels.
The UK’s withdrawal from the EU has seen the influence of many UK agencies and regulatory bodies decline, including the MHRA which oversees the safety and quality of medicines and MedTech.
Cook Medical believes that the equivalent Irish body, the HPRA, has the potential to fill this vacuum with backing from the Irish Government.
“The HPRA is well regarded in Brussels, and has played an instrumental part in developing the Medical Device Regulation. With the UK’s MHRA wielding less influence and authority, there is an opportunity for the HPRA to take on a leading role directing and shaping EU MedTech policy,” said Mr Devereux.
“However, this will require additional resourcing and investment from the Irish Government, and long-term collaboration with Ireland’s MedTech and pharmaceuticals companies. We believe that this is integral to ensure that Ireland continues to have a strong voice at the table in a post-Brexit Europe and that we can continue to be a global leader in MedTech.”
About Cook Medical
Since 1963 Cook Medical has worked closely with physicians to develop technologies that eliminate the need for open surgery. Today we are combining medical devices, biologic materials and cellular therapies to help the world’s healthcare systems deliver better outcomes more efficiently. We have always remained family owned so that we have the freedom to focus on what we care about: patients, our employees and our communities. Find out more at cookmedical.eu, and for the latest news, follow us on Twitter, Facebook and LinkedIn.