Hopes of the UK becoming a global innovation hub for new medical devices after Brexit will be stifled if the UK diverges 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, sectoral leaders from both industry and academia said there was growing concern that Britain was setting the wrong course for future regulation.
Since Brexit, the UK has decided not to implement the EU’s new Medical Device Regulation (MDR), which places much greater burdens on companies to prove devices are both safe and deliver patient benefits following a series of scandals caused by malfunctioning breast implants and surgical meshes.
Instead, the UK is seeking to create a bespoke regulatory system that Lord James Bethell, the health department’s innovation minister, said this month is designed to “grasp the opportunity of innovation now we have left the EU”.
However, early drafts of the new regulation seen by insiders have rattled the industry, which is heavily reliant on exports to EU markets that represent nearly 22 per cent of global healthcare spending according to figures from Imperial College, London — compared with just 3 per cent in the UK.
Kevin Kiely, the chief executive of Medilink UK, a professional association that represents more than 1,300 small businesses making medical devices, said the UK system “absolutely” needed to mirror the EU system because that is where British companies sold their products.
“The early drafts have not been encouraging. The reality is that we’ve got to sell into Europe, so all companies have to comply with MDR anyway. The last thing they need is yet another audit trail that duplicates what they already have to do in Europe,” he said.
Senior academics also warned that patients and industry risked losing the fruits of British innovation because investors would spend time and money registering devices in the EU or the US, which represent 43 per cent of global health spending.
James Moore, professor of medical device design at Imperial College, London, said a divergent UK regulatory system could deter investment and the retention of successful products once brought to market.
“The worry is that you’ll see damage in terms of companies forming here in the UK — they’ll just vaporise and go to another country,” he said.
Derek Hill, professor of biomedical engineering at University College London, said a unique UK system, while holding out the possibility of some benefits, risked piling further burdens on companies.
“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’re creating UK-specific rules and tests, and companies may ask ‘are we going to bother?’,” he said.
The UK government has agreed to continue recognising the EU’s standard “CE” mark until July 2023, while it creates a new regulatory system. A consultation will start this summer with secondary legislation clarifying new rules expected in the spring of 2022.
Daniel Green, the chief executive of Yaqrit, a spinout from University College London that is in the process of obtaining certification for a revolutionary dialysis machine for patients suffering from liver cirrhosis, said any bespoke new UK regulations had to have a clear benefit to patients.
“If we have to invest in regulatory approval 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 the capital. If any country tries to create additional hurdles to approval, industry responds to those incentives,” he said.
Giovanna Forte, the chief executive of Forte Medical, which has recently brought a urine-testing device to market, said the long term goal should be to create a global standard that harmonised and mutually recognised rules across jurisdictions, not divergence.
“I don’t see why the UK should have a different standard to the EU. There’s a strand of contrariness with this government that says it 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 because of a shortage of professional assessment, or “notified bodies”, following the decision of several larger providers to pull out of the market, leaving only three approved bodies for medical devices in the UK.
The 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 regime that would make the UK an attractive place to introduce products.
Phil Brown, ABHI’s director of regulatory and compliance issues, said that “unconsidered divergence” and regulatory duplication would “increase cost and reduce innovation” in a sector that comprises 90 per cent SMEs and is therefore extremely cost-sensitive.
However he added that given difficulties implementing MDR in the EU, where “notified bodies” were struggling to keep pace with the changes, the UK could potentially design a more agile and globally focused system.
One key demand is to ensure that trial data collected for registrations in the EU and US should be compatible with obtaining a registration in the UK.
The MHRA, which is also seeking to become a fast-track regulator of innovative medicines post-Brexit, said in a statement that it was aiming to develop a “best-in-class” regulatory environment that would build on international best practice.
And while much of the industry is worried about divergence, there is a hope in some quarters that a new British system, while sticking to the core of the EU system for data, could provide a faster route to market for some products.
Among the areas being examined where the UK could outstrip an increasingly bureaucratic EU system, is better regulation of software in medical devices, a lighter touch regime for low-risk items and faster interactions with early-stage companies.
Neelam Patel, the chief executive of MedCity, a life sciences cluster organisation for London, said the UK could find a regulatory sweet spot that also leveraged the NHS as a unique patient test-bed for new products.
“The MHRA has a good opportunity to use what is current and evolve it to long term needs, not only for patients, but also companies and markets as a whole,” she said.