The medical device industry is testing UK plans for post-Brexit divergence

Hopes that the UK will become a global innovation hub for new medical devices after Brexit will be dashed if the UK differs from EU standards in pursuit of a post-Brexit regulatory dividend, they warned industry experts.

Ahead of a formal government consultation process later this summer, sector leaders in 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 New EU Medical Device Regulation (MDR), which places a much greater burden on companies to demonstrate that the devices are safe and offer benefits to patients after a series of scandals caused by malfunctioning breast implants and surgical meshes.

Instead, the UK is looking to create a regulatory system as Lord James Bethell, the health department’s innovation minister, he said this month it is designed to “seize the opportunity to innovate now that we have left the EU”.

However, the first drafts of the new regulation seen by the privileged have affected the industry, which is heavily dependent on exports to EU markets which account for almost 22% of global health spending according to Imperial College data of London, compared to only 3%. in the United Kingdom.

Kevin Kiely, CEO of Medilink UK, a professional association representing more than 1,300 small medical device manufacturers, said the British system needed to “absolutely” reflect the EU system because it is where British companies sold their products. .

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

Senior academics also warned that patients and industry risk losing the fruits of British innovation because investors would spend time and money registering devices in the EU or the US, which account for 43% of global health spending. .

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

“The concern is that you will see damage in terms of companies being formed here in the UK – they will simply vaporize and leave for another country,” he said.

Derek Hill, a professor of biomedical engineering at University College London, said a unique UK system, while offering the possibility of some benefits, risked accumulating new burdens on companies.

“It is difficult for the UK to be a truly independent regulator. If we want to be more respectful of innovation, the problem is that you are creating UK-specific rules and tests and companies may ask us “do we bother?” “, He said.

The UK government has agreed to continue recognizing the EU’s standard “CE” mark until July 2023, while creating a new regulatory system. The consultation will begin this summer with secondary legislation clarifying the new rules set for the spring of 2022.

Daniel Green, executive director of Yaqrit, a subsidiary of University College London that is in the process of obtaining certification for a revolutionary dialysis machine for patients with liver cirrhosis, said any new tailor-made UK regulations should 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 capital. If any country tries to create additional barriers to approval, the industry responds to these incentives, ”he said.

Giovanna Forte, CEO of Forte Medical, which recently introduced a urine test device to the market, said the long-term goal should be to create a global standard that harmonizes and mutually recognizes rules across jurisdictions, not divergences.

“I do not see why the UK should have a different standard from the EU. There is a line of opposition with this government that says it will make everything easy, but these people do not know how to run a business, they have never done it, ”said Forte.

There is a line of annoyance with this government that says it will make everything easy, but these people don’t know how to run a business.

British innovators in the sector are already struggling due to the lack of professional evaluation or “notified bodies”, following the decision of several larger suppliers to leave 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 regulatory agency for medicines and health products (MHRA), to create a regulatory regime that would make the UK United an attractive place to introduce products.

Phil Brown, ABHI’s director of regulatory and compliance issues, said “unforeseen divergence” and regulatory duplication “would increase costs and reduce innovation” in a sector comprising 90% of SMEs and therefore it is extremely cost sensitive.

However, he added that given the difficulties in implementing MDR in the EU, where “notified bodies” were struggling to keep pace with change, the UK could design a more agile and global system.

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

The MHRA, which it is too looking to become a fast track regulator of innovative medicines after Brexit, said in a statement that it sought to develop a “best-in-class” regulatory environment based on international best practices.

And while much of the industry is concerned about the divergence, there is hope in some sectors that a new British system, while adhering to the core of the EU data system, could provide a faster route. in the market for some products.

Among the areas being examined where the UK could overcome an increasingly bureaucratic EU system are better regulation of software on medical devices, a lighter tactile regime for low-risk items and faster interactions. with companies in the initial phase.

Neelam Patel, CEO of MedCity, a life sciences cluster organization in London, said the UK could find a regulatory point that would also take advantage of the NHS as the only patient testing ground for new products. .

“The MHRA has a good opportunity to use what is current and develop it to long-term needs, not only for patients, but also for businesses and markets in general,” he said.