UK experts who will become a global innovation hub for new medical devices after Brexit will be stunned if the UK diverges from EU rules in search of a post-Brexit regulatory dividend, experts have warned of industry.
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 preparing the wrong course for future regulation. .
Since Brexit, the UK has decided not to implement it The new EU Medical Device Regulation (MDR), which places much greater weight on companies to demonstrate that the devices are both safe and give benefits to patients after a series of scandals caused by malfunctions of breast implants and surgical meshes.
Instead, the UK is looking to create a tailor-made regulatory system that Lord James Bethell, the health department’s innovation minister, said. he said this month it is intended to “understand the innovation opportunities we have now left the EU”.
However, the first draft of the new regulation seen by the initiators has shaken up the industry, which is heavily dependent on exports to EU markets which account for almost 22 per cent of world health spending according to the figures. ‘Imperial College London – compared to only 3 per cent in the UK.
Kevin Kiely, executive director of Medilink UK, a professional association representing more than 1,300 small businesses that manufacture medical devices, said the UK system “absolutely” needed to respect the EU system because that’s where companies British sell their products.
“The first projects weren’t encouraging. The reality is that we’re going to sell in Europe, so all companies have to comply with MDR anyway. The last thing they need is another control track that reproduces what they have. they already have work to do in Europe, ”he said.
Senior academics have also warned that patients and industry risk losing the fruits of British innovation because investors spend time and money to register devices in the EU or the US, representing 43 per cent. percent of global health spending.
James Moore, professor of medical device design at Imperial College, London, said a divergent British regulatory system could deter investment and retention of successful products once they are brought to market.
“The concern is that you will see damage in terms of companies forming here in the UK – they just vaporize and go to another country,” he said.
Derek Hill, a professor of biomedical engineering at University College London, said a single UK system, while holding the possibility of some benefit, risked accumulating additional burdens on companies.
“It’s difficult for the UK to be a truly independent regulator. If we want to be more friendly to innovation, the problem is that specific rules and texts have been created for the UK, and companies can ask, ‘Shall we bother?’ , He said.
The UK government has agreed to continue recognizing the EU’s “CE” standard mark until July 2023, while creating a new regulatory system. A consultation is set to begin this summer with secondary legislation clarifying the new rules set for the spring of 2022.
Daniel Green, executive director of Yaqrit, a spinout of University College London that is on track to obtain certification for a revolutionary dialysis machine for patients suffering from liver cirrhosis, said each new regulation would be tailored of the United Kingdom should have a clear benefit for patients.
“If we have to invest in regulatory approvals in the US, the EU and the UK, each will have a different return on capital, and the one with the best return will attract capital. If any country tries to create additional barriers to ‘approval, the industry is responding to these incentives,’ ”he said.
Giovanna Forte, executive director of Forte Medical, which recently brought to market a urine test device, said the long-term goal should be to create a global standard that harmonizes and recognizes mutual rules across all jurisdiction, not divergence.
“I don’t see why the UK should have a different standard than the EU. There’s a thread of opposition with this government that says it makes everything easy, but these people don’t know how to run a business, they never have it. “, said Forte.
UK innovators in the sector are already struggling due to a lack of professional evaluation, or “notified bodies”, following the decision of several larger suppliers to pull out of the market, leaving only three approved bodies for medical devices in the UK.
The ABHI, the UK’s leading medical technology industry association, said it was working with the UK regulator, the Medicines and Health Products Regulatory Agency (MHRA), to create a regulatory regime that would make the UK an attractive place to present products.
Phil Brown, ABHI’s director of regulatory and compliance issues, said the “inconsistent divergence” and regulatory duplication “will increase costs and reduce innovation” in a sector that includes 90 percent SMEs and is therefore extremely sensitive to the costs.
However he added that, given the difficulties in implementing MDR in the EU, where “notified bodies” are struggling to keep pace with change, the UK could potentially devise a more agile and focused system in the world.
A key requirement is to ensure that the test data collected for registrations in the EU and the US are compatible with obtaining a registration in the UK.
The MHRA, that is too looking to become a fast regulator of innovative post-Brexit medicines, said in a statement that it aimed to develop a regulatory environment “best in its class” that will be based on international practices.
And while much of the industry is concerned about the divergence, there is hope in some quarters that a new UK system, while sticking to the core of the EU’s data system, could provide a further path. fast to the market for some products.
Among the areas under consideration where the UK could overcome an increasingly bureaucratic EU system are better regulation of software on medical devices, a lighter touch regime for low-risk items and faster interactions with companies in the first stage.
Neelam Patel, executive director of MedCity, a life sciences cluster organization for London, said the UK could find a sweet regulatory spot that also exploited the NHS as a single bed test for newcomers. products.
“The MHRA has a good opportunity to address what is current and evolving for long-term needs, not only for patients, but also for companies and markets in general,” he said.