Hopes that the UK will become a global innovation hub for new medical devices after Brexit will be stifled if the UK departs from EU standards in search of a post-Brexit regulatory dividend. Brexit, have warned industry experts.
Ahead of a formal government consultation process later this summer, sector leaders in industry and academia said there was growing concern Britain was choosing the wrong path for future regulation.
Since Brexit, the UK has decided not to implement the The new EU medical device regulation (MDR), which places a much greater burden on companies to prove that the devices are both safe and provide benefits to patients following a series of scandals caused by defective breast implants and surgical nets.
Instead, the UK is looking to create a bespoke regulatory system that Lord James Bethell, the Minister for Innovation at the Department of Health, said this month is designed to ‘seize the opportunity for innovation now that we have left the EU’.
However, the first drafts of the new regulation seen by insiders rocked the industry, which relies heavily on exports to EU markets which account for nearly 22% of global health spending according to figures from Imperial College of London – compared to just 3% in the UK.
Kevin Kiely, managing director of Medilink UK, a trade association that represents more than 1,300 small medical device companies, said the UK system “absolutely” needs to mirror the EU system because that’s where companies British people were selling 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 MDR anyway. The last thing they need is another audit trail that duplicates what they already have to do in Europe, ”he said.
Senior academics have also warned that patients and industry stand to lose the fruits of British innovation as investors waste time and money registering devices in the EU or the US, which represent 43% 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 retention of successful products once they hit the market.
“The worry is that you will see damage in terms of businesses forming here in the UK – they are just going to vaporize and go to another country,” he said.
Derek Hill, professor of biomedical engineering at University College London, said that a one-size-fits-all UK system, while offering the potential for some benefits, could increase burdens on businesses.
“It is difficult for the UK to be a truly independent regulator. If we’re going to be more supportive of innovation, the problem is you are creating UK specific rules and tests, and companies can ask ‘are we going to care? ” “, did he declare.
The UK government has agreed to continue recognizing the EU standard ‘CE’ mark until July 2023, time to create a new regulatory system. A consultation will begin this summer with a secondary law clarifying the new rules expected in spring 2022.
Daniel Green, chief executive of Yaqrit, a University College London spin-off company that is in the process of obtaining certification of a revolutionary dialysis machine for patients with cirrhosis of the liver, said any new UK regulations on measure was to have a clear benefit for patients.
“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 barriers to approval, the industry responds to those incentives, ”he said..
Giovanna Forte, managing director 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 recognizes rules between jurisdictions, and not the discrepancies.
“I don’t see why the UK should have a different standard than the EU. There is a current of contradiction with this government that says it will make everything easy, but these people don’t know how to run a business, they never have, ”said Forte.
UK innovators in the industry are already struggling due to a shortage of professional assessments, or ‘notified bodies’, following the decision of several major suppliers to withdraw from the market, leaving only three accredited bodies for medical devices in the UK.
ABHI, the UK’s leading association for the medical technology industry, 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 introduce products.
Phil Brown, director of regulatory and compliance issues at ABHI, said that “reckless divergence” and regulatory duplication “would increase costs and reduce innovation” in an industry that comprises 90% of SMEs and is therefore extremely cost sensitive.
However, he added that given the difficulties of implementing MDR in the EU, where ‘notified bodies’ struggled to keep up with the pace of change, the UK could potentially design a more agile system and more global.
One of the main requirements is to ensure that the test data collected for registrations in the EU and the United States is compatible with obtaining a registration in the United Kingdom.
The MHRA, which also seeks to become a fast-track regulator of innovative medicines after Brexit, said in a statement that it aims to develop a “top-notch” regulatory environment that would build on international best practices.
And while much of the industry is worried about the discrepancies, some are hopeful that a new UK system, while remaining at the heart of the EU data system, could provide a faster route to market for some products.
Some areas under review where the UK could move beyond an increasingly bureaucratic European system include better regulation of software in medical devices, a lighter touch regime for low-risk items and faster interactions with businesses. in startup.
Neelam Patel, managing director of MedCity, a life sciences cluster organization for London, said the UK could find a sweet spot for regulation that also leverages the NHS as a single test bed for patients for new products.
“The MHRA has a good opportunity to use what’s current and adapt it to long-term needs, not only for patients, but also for businesses and markets as a whole,” she said. .