Medical device industry tests UK plans for post-Brexit divergence

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Hopes of the UK becoming a global innovation hub for new medical devices after Brexit will be dashed if the UK deviates from EU standards in search of a post-Brexit regulatory dividend, industry experts have warned.

Ahead of a formal government consultation process later this summer, sector leaders from industry and academia said they had growing fears Britain was setting the wrong course for future regulation.

Since Brexit, the UK has decided not to implement the new European Medical Devices Regulation (MDR), which imposes much greater burdens on companies to prove that devices are both safe and beneficial to people. patients following a series of scandals caused by defective breast implants and surgical mesh. .

Instead, the UK is seeking to create a bespoke regulatory system which, according to Lord James Bethell, Minister for Innovation in the Department of Health, is designed this month to “seize the opportunity of the innovation now that we have left the EU”.

However, early drafts of the new regulations seen by insiders have rattled the industry, which relies heavily on exports to EU markets which account for nearly 22% of global healthcare spending according to Imperial College figures. of London – compared to just 3% in the UK.

Kevin Kiely, chief executive of Medilink UK, a trade association which represents more than 1,300 small companies making medical devices, said the UK system must “absolutely” mirror the EU system because that is where companies British sold their products.

“The first drafts were not encouraging. The reality is that we have to sell in Europe, so all companies have to comply with the MDR anyway. The last thing they need is another audit trail that duplicates what they already have to do in Europe,” he said.

Top academics have also warned that patients and industry risk losing the fruits of UK innovation as investors spend time and money registering devices in the EU or US, which represent 43% of global health expenditure.

James Moore, professor of medical device design at Imperial College London, said a divergent UK regulatory system could discourage investment and retention of successful products once they hit the market.

“The concern is that you will see damage in terms of business start-ups here in the UK – they will just vaporize and go to another country,” he said.

Derek Hill, professor of biomedical engineering at University College London, said a one-size-fits-all UK system, while offering the possibility of some benefits, risked increasing the burden on businesses.

“It is difficult for the UK to be a truly independent regulator. If we want to be more innovation-friendly, the problem is that you create UK-specific rules and tests, and companies can ask ‘are we going to mess with each other?’, he said.

The UK government has agreed to continue to recognize the standard EU ‘CE’ mark until July 2023, while it creates a new regulatory system. A consultation will begin this summer with secondary legislation clarifying new rules expected in spring 2022.

Daniel Green, chief executive of Yaqrit, a University College London spin-off that is in the process of getting certification for a breakthrough dialysis machine for patients with liver cirrhosis, said any new UK regulations tailored had to have a clear benefit for patients.

Daniel Green: “If a country tries to create additional barriers to approval, the industry responds to those incentives”

“If we are to invest in regulatory approval in the US, EU and UK, each will have a different return on capital, and the one with the best return will attract capital. If a country tries to create additional hurdles to approval, the industry responds to these incentives,” he said..

Giovanna Forte, chief executive of Forte Medical, which recently brought a urine testing device to market, said the long-term goal should be to create a global standard that harmonizes and mutually recognizes rules across jurisdictions. , not the divergence.

“I don’t see why the UK should have a different standard than the EU. There is a bit of a contradiction with this government saying they will make everything easy, but these people don’t know how to run a business, they never have,” Forte said.

UK innovators in the sector are already struggling due to a lack of professional assessment, or ‘notified bodies’, following the decision of several major suppliers to pull out of the market, leaving just three approved bodies for medical devices UK.

The ABHI, Britain’s leading medical technology industry association, said it was working with Britain’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), to create a regulatory regime that would make the UK Kingdom an attractive place to introduce products.

Phil Brown, director of regulatory and compliance issues at ABHI, said “reckless divergence” and regulatory duplication would “increase costs and reduce innovation” in a sector that comprises 90% of SMEs and is therefore extremely cost sensitive.

Giovanna Forte: “I don’t see why the UK should have a different standard than the EU”

However, he added that given the difficulties of implementing MDR in the EU, where ‘notified bodies’ were struggling to keep up with the pace of change, the UK could potentially design a more agile and efficient system. focused on the world.

One of the key requirements is to ensure that test data collected for EU and US registrations is compatible with obtaining a UK registration.

The MHRA, which is also seeking to become a fast-track regulator of innovative medicines after Brexit, said in a statement it aimed to develop a “best in class” regulatory environment that would build on international best practice.

And while much of the industry is worried about the discrepancies, some hope that a new UK system, while still faithful to the European data system, could provide a faster route to market for certain products. .

Among the areas examined where the UK could leapfrog an increasingly bureaucratic EU system are better regulation of software in medical devices, a lighter touch regime for low-risk items and faster interactions with start-up companies.

Neelam Patel, chief executive of MedCity, a life science cluster organization for London, said the UK could find a regulatory sweet spot that would also leverage the NHS as a one-stop test bed for new products.

“The MHRA has a good opportunity to take what is current and adapt it to long-term needs, not just for patients, but also for businesses and markets as a whole,” she said. .

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