If the UK strays from EU standards in search of a post-Brexit regulatory dividend, industry experts warn that post-Brexit hopes of the UK becoming a global innovation hub for new medical devices will be thwarted, industry experts warn.
Ahead of the government’s formal consultation process later this summer, industry and academic leaders said there is growing concern that the UK is setting the wrong direction for future regulation.
After Brexit, the UK has decided not to implement the European Union’s new Medical Devices Regulation (MDR). This regulation places even greater pressure on businesses to ensure that devices are safe and benefit patients following a series of scandals resulting from malfunctioning breast implants and surgical meshes. .
Instead, the UK is trying to create a custom regulatory system. The Ministry of Health’s Minister of Innovation, Lord James Bethell, said this month that it is designed “to seize the opportunity to innovate now that we leave the EU.”
But an early draft of the new regulation, seen by insiders, shook the industry. The industry relies heavily on exports to the EU market, which accounts for nearly 22% of global health spending, which is only 3% according to figures from Imperial College London. in the UK.
Kevin Kiely, CEO of Medilink UK, a professional association representing more than 1,300 small businesses that make medical devices, said the UK system needs to “must” reflect the EU system. Because that’s where British companies sell their products.
“The initial draft was not encouraging. The reality is that every company has to comply with the MDR anyway because we have to sell to Europe. The last thing they need is another audit trail that replicates what Europe already has to do,” he said.
Senior scholars also warned that patients and the industry risk losing the fruits of UK innovation as investors will spend time and money registering devices in the EU or the US, which account for 43% of global healthcare spending.
James Moore, professor of medical device design at Imperial College London, said the UK’s diverse regulatory system could deter investment and retention of successful products once they’re on the market.
“The worry is that you’re going to lose money to set up a company here in the UK. The company will evaporate and go to other countries,” he said.
Derek Hill, professor of biomedical engineering at University College London, said the UK-native system risks putting additional strain on businesses while retaining the potential for some benefits.
“It is difficult for the UK to become a truly independent regulator. If we want something more innovation-friendly, the problem is that we’re making UK-specific rules and tests, and companies can ask ‘Are we going to bother?’” he said.
The UK government has agreed to continue to recognize the EU’s standard “CE” mark until July 2023 while creating a new regulatory system. Consultations will begin this summer, with a second legislative session clarifying new rules expected in the spring of 2022.
Daniel Green, CEO of Yaqrit, a spin-out of University College London that is in the process of obtaining innovative catapult certification for patients suffering from cirrhosis, said the customized new UK rule should have clear benefits for patients.
Daniel Green: ‘If a country tries to create additional barriers to approval, the industry responds to these incentives’
“If you need to invest in regulatory approvals in the US, EU and UK, each has a different return on capital, and the companies with the highest returns attract the capital. The industry responds to these incentives when a country tries to create additional barriers to approval,” he said.
Giovanna Forte, CEO of Forte Medical, which recently launched a urine test device, said the long-term goal is not to make a difference, but to create a global standard that creates harmonized and mutually accepted rules across jurisdictions.
“I don’t see why the UK should have different standards than the EU. There’s a contradiction in saying that this government will make everything easy, but these people don’t know how to run a business and they don’t know at all,” Forte said.
This government says it will make everything easier, but the contradiction is that these people don’t know how to run a business.
UK innovators in the field are already struggling with a lack of professional appraisal or “accredited bodies” after several large suppliers have decided to withdraw from the market, and there are only three approved bodies for medical devices in the UK.
ABHI, the UK’s leading medical technology industry association, said it is working with the UK regulator, the Medicines and Healthcare Products Regulatory Authority (MHRA), to create a regulatory framework that will make the UK an attractive place for product introductions.
Phil Brown, ABHI’s Director of Regulatory and Compliance Matters, said in an extremely cost-sensitive sector, with 90% of small businesses, “unconsidered gaps” and regulatory duplication will “increase costs and reduce innovation” .
Giovanna Forte: ‘I don’t know why the UK should have different standards than the EU’
However, he added, given the challenges of implementing MDR in the EU where “certification bodies” are struggling to keep pace with change, the UK could potentially design a more agile and globally focused system.
One key requirement is that the test data collected for EU and US registrations must be compatible with obtaining UK registrations.
MHRA, which is working to become a post-Brexit fast-track regulator of innovative medicines, said in a statement that it aims to develop a “best-of-best” regulatory environment based on international best practices.
And while much of the industry is worried about the difference, in some quarters there is hope that the new UK system can provide a faster path to market for some products while sticking to the heart of the EU system for data.
Among the areas of investigation where the UK could outperform the increasingly bureaucratic EU system are better regulation of software in medical devices, a lighter touch regime for low-risk items, and faster interactions with early-stage companies.
Neelam Patel, CEO of London-based life sciences cluster organization MedCity, said the UK could find a regulatory sweet spot to use the NHS as a unique patient testbed for new products.
“MHRA has a great opportunity to use what is now and evolve it to meet long-term needs, not just for patients, but for businesses and the market as a whole,” she said.
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