Industry experts have warned of hopes that the UK could become a global innovation hub for new medical devices after Brexit, if the UK moved away from EU standards in search of post-Brexit regulatory gains.
Ahead of a formal government consultation process later this summer, sector leaders from both industry and academia said there was growing concern that Britain was setting the wrong course for future regulation.
Since Brexit, the United Kingdom has decided not to implement New EU Medical Device Regulation (MDR), which places a much greater burden on companies to prove that the devices are safe and provide benefits to patients after a series of scandals caused by flawed breast implants and surgical networks.
Instead, the UK is seeking to create a bespoke regulatory system by Lord James Bethel, Minister for Innovation in the Department of Health, He said this month It was designed “to seize the opportunity to innovate now that we have left the European Union”.
However, early drafts of the new regulations seen by insiders have rocked the industry, which relies heavily on exports to EU markets that account for nearly 22 per cent of global healthcare spending according to figures from Imperial College, London – compared to 3 per cent in the UK.
Kevin Kelly, chief executive of Medilink UK, a professional association representing more than 1,300 small companies making medical devices, said the UK system “needs completely” to reverse that of the EU because that is where UK companies sell their products.
“Early drafts were not encouraging. The truth is we have to sell in Europe, so all companies have to comply with MDR standards anyway. The last thing they need is another audit trail that replicates what they already have to do in Europe,” he said.
Leading academics have also warned that patients and industry risk losing the fruits of British innovation because investors will spend time and money registering devices in the European Union or the United States, which account for 43 per cent of global health spending.
James Moore, professor of medical device design at Imperial College London, said a differentiated regulatory regime in the UK could deter investment and retention of successful products once they are on the market.
“What’s worrying is that you will notice the damage in terms of businesses that are forming here in the UK – they will just evaporate and go to another country,” he said.
Derek Hill, professor of biomedical engineering at University College London, said a system that is unique in the UK, while holding the potential for some benefits, risks piling more burdens on companies.
“It’s hard for the UK to be a really independent regulator. If we want to be more conducive to innovation, the problem is that you set UK-specific rules and tests, and companies might ask ‘Are we going to bother?'” he said.
The UK government has agreed to continue recognizing the EU standard ‘CE’ mark until July 2023, while creating a new regulatory regime. This summer’s consultations will begin with secondary legislation outlining the new rules expected in the spring of 2022.
Daniel Green, chief executive of Yakret, a University College London subsidiary in the process of certification for a revolutionary dialysis machine for patients with cirrhosis, said any new UK regulations should have a clear benefit to patients.
“If we were to invest in regulatory approval in the US, EU and UK, they would each have a different return on capital, and the one that yields the best return would attract capital. If any country tries to create additional obstacles to approval, the industry responds to those incentives..
Giovanna Forte, CEO of Forte Medical, which recently brought the urine test device to market, said the long-term goal should be to create a global standard that aligns with mutually recognized rules across jurisdictions, not divergence.
I don’t understand why the UK should have a different standard than the EU. “There is a disagreement with this government saying it will make everything easy, but these people don’t know how to run a business, they never did,” Forte said.
British innovators in the sector are already suffering due to a lack of professional evaluation, or ‘reporting bodies’, after the decision of several major providers to withdraw from the market, leaving Only three accredited bodies for medical devices in the UK.
ABHI, the UK’s main medical technology industry association, said it was working with the UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), to create a regulatory system that would make the UK an attractive place to offer products.
Phil Brown, Director of Regulatory Affairs and Compliance at ABHI, said that “unconsidered divergence” and regulatory duplication would “increase cost and reduce innovation” in a sector that includes 90 percent of SMEs and is therefore highly cost sensitive.
However, he added that given the difficulties of implementing MDR in the EU, where “notifying bodies” are struggling to keep pace with changes, the UK could design a more flexible and focused system globally.
One of the main demands is to ensure that empirical data collected for registrations in the European Union and the United States must be compatible with obtaining a registration in the UK.
MHRA, which is also Striving to become a fast-track entrepreneur of innovative medicines after Brexit, it said in a statement that it aims to develop a “best in class” regulatory environment that will build on international best practice.
And while much of the industry is concerned about the difference, there is hope in some quarters that the new British system, while sticking to the core of the EU data system, could provide a faster path to market for some products.
Among the areas being examined where the UK could outpace the increasingly bureaucratic EU system are better regulation of software in medical devices, a lighter touch system for low-risk items and faster interactions with early-stage companies.
Neelam Patel, chief executive of MedCity, an organization that brings together the life sciences in London, said the UK could find a great regulatory venue that has also benefited from the NHS as a unique patient test bed for new products.
“MHRA has a good opportunity to use and develop what is current to meet the long-term needs, not only of patients, but also of businesses and markets as a whole,” she said.