Medical Technology Regulations and the NHS

Gary Streeter Excerpts

Tuesday 28th March 2023 Westminster Hall

[The Minister for Health and Secondary Care (Will Quince)]

It is a pleasure to serve under your chairmanship, Sir Gary. I congratulate my hon. Friend the Member for Gosport (Dame Caroline Dinenage) on securing this important debate. I am grateful for the opportunity to update her and the House on the subject, and I am proud to showcase the investments that the Government are putting into life sciences.

My hon. Friend showed eloquently and articulately that medical technology is of huge importance to the UK and its health and care system. As she rightly said, the regulations that govern medtech have to protect patients and ensure public safety. It is also important that they encourage investment and drive innovation in the sector. The NHS spends an estimated £10 billion a year on medical tech, and the sector is an essential provider of jobs and specialist skills across the UK. The hon. Member for Denton and Reddish (Andrew Gwynne) set out the value of medtech to UK plc; there are no fewer than 138,000 jobs in the sector in this country.

My hon. Friend the Member for Gosport rightly highlighted how the UK’s decision to leave the EU, coupled with huge advances in life sciences and diagnostics —many of which the hon. Member for Denton and Reddish set out—has presented a great opportunity for us to reform our medical devices regulatory regime. We are well placed to do that, and we have to seize the opportunity.

We have a dynamic and pioneering medtech sector and a world-renowned regulator in the Medicines and Healthcare products Regulatory Agency, which most people know as the MHRA. I know that there have been challenges with the MHRA, as my hon. Friend the Member for Gosport set out, and I will come to that in a moment. Before I do, I want to touch on the work that the MHRA is doing to update the medical devices regulatory regime.

The first set of changes will be delivered this year—in fact, by the summer. The updated regime will deliver improved patient safety, greater transparency and closer alignment with international best practice, as my hon. Friend rightly pointed out, and it will ensure that regulation is proportionate. I am still very much alive to the scale of change and the huge importance of giving the sector—as the hon. Member for Denton and Reddish set out, many of its businesses are small and medium-sized enterprises—the time that it needs to adapt. Certainty of supply and access to medical devices in the NHS is critical, so we will intentionally phase in the regulatory changes in stages to give industry certainty.

I want to touch on two other areas, both of which are really important to the industry: artificial intelligence and new routes to market. In both cases, the new regulations will support innovation in the UK’s life sciences sector and, importantly, accelerate access to innovative medical devices for UK patients.

We are improving the regulation of novel and growing areas such as AI to ensure that our systems are responsive to technological advances. We have to ensure that we continue to be best in class and world class in this space. I want us to be world leaders in the regulation of new technologies and new approaches, such as AI. At the heart of that ambition is our desire for patients here in our United Kingdom to have access to the very latest innovations in medical technology. I want them to have that as quickly as possible, and agility is key to ironing out the bureaucratic processes that historically have caused delay.

New routes to market are important because they will enhance the supply of devices, including the most cutting-edge products. The regulations will introduce a new pathway to support the use of real-world evidence in the conformity assessment process, with proportionate regulatory oversight for these devices. To be absolutely clear, though, because we cannot lose sight of this, the focus of the MHRA must be patient safety. That must remain paramount.

Importantly for UK plc—I turn directly to the point made by the hon. Member for Denton and Reddish—I believe that these improvements will help to create opportunities for small and medium-sized enterprises, including by ensuring that UK businesses have the ability to supply their UK-made and UK-developed products to the NHS and get them in use for patients more quickly.

I mentioned that my Department’s priority is to ensure that innovative, safe and effective devices reach patients as quickly as possible. That is an area of real focus and one where I want us to improve. Our inaugural medtech strategy, which was published last month, has been mentioned by everybody who has spoken. The strategy is key, because it recognises many of the systemic challenges to adopting innovative products that hon. Members across the Chamber have set out. It sets out a clear ambition to provide a streamlined pathway from pre-registration through to adoption in the NHS, which the hon. Member for Strangford (Jim Shannon) rightly pointed out. Importantly, it will ensure rapid progression for priority innovative products, including drugs, as my hon. Friend the Member for Gosport rightly said. The medtech strategy sets out our ambition and clear signals as to what we want to achieve.

Both my hon. Friend and the hon. Member for Denton and Reddish asked how we identify the products needed for the future, so that we can set innovators off to design products that tackle the challenges we face. We are working closely with senior clinicians across the NHS. It is our ambition to set out the big challenges in the health and care system, and then to give those challenges to innovators—ideally, but not exclusively, in this country—and set their minds, businesses, organisations and capital to work to design the products and devices that we need. That will allow us to introduce novel products to the NHS, and therefore our patients, faster.

I genuinely believe that medtech has the most enormous potential to improve patient outcomes, and I know that my hon. Friend the Member for Gosport does too, as a former Health Minister and a former Digital Minister—two areas that are very much combined in this debate. I see that potential already on my visits around the country —from a particular type of plaster that enables a wound to heal faster, to robotic surgery equipment that costs many millions of pounds. They have very different functions, but both fall under medtech regulations. It is therefore vital that we work more closely with industry to ensure that we have a robust pipeline of innovations that can be adopted at pace and scale, and can then support the delivery of our and the NHS’s key priorities.

The inaugural medtech strategy is an important milestone, but it is also important to back it with funding. As my hon. Friend rightly pointed out, the Government recognise the opportunities that we have before us and the importance of this topic. That is exactly why, in the Budget—the evidence is there—the Chancellor of the Exchequer announced £10 million of additional funding for the MHRA over the next two years. That will help us to bring innovative medicines and medtech to patients more quickly. It will support the development of a shortened but still thorough approval process for cutting-edge treatments such as cancer vaccines, which is an area that we are investing in considerably alongside industry. There is also AI-based technology. I know that I have mentioned AI a number of times, but it is the most exciting area of medtech. For example, the relatively new AI-based app Sleepio, which provides tailored therapy for insomnia at the touch of a button, is the kind of technology that will transform the lives of patients in our NHS.

My hon. Friend rightly mentioned international recognition, which I recognise is so important and is one of the Brexit opportunities that has come about. The funding will also be used to establish an international recognition framework, which will allow the MHRA to fast-track the approval of medicinal products that have been approved in other trusted countries. That will address the unnecessary duplication of regulatory processes from countries with the same standards as us and therefore reduce the time it takes for essential products to reach our market. It will make the most of the MHRA’s resources. Finally and critically, the additional funding put in by the Chancellor only a week or so ago will ensure that the MHRA has the resource and infrastructure more broadly to deliver on our ambitious vision for UK patients, by increasing the availability of life-saving medtech devices on the UK market while maintaining proportionate regulatory oversight to protect patients.

My hon. Friend asked three specific questions. The first was about the timescale and the fact that we need to act fast. She is absolutely right. We have published the medtech strategy, which has largely been welcomed by industry. The first set of changes will come in this summer. Then there will be a transition period for CE-marked devices into law. Later this year, we will introduce post-market surveillance requirements. Other updates will follow, but I am acutely aware that industry must have sufficient notice, and I will ensure that it has that throughout.

My hon. Friend’s second question was in relation to dementia and Alzheimer’s drugs. I will look very carefully at that. Understandably, the MHRA and NICE are independent, but of course I would be very happy to meet representatives of Alzheimer’s Research UK, because I understand the importance of potential new drugs. If a drug has received FDA approval, we would want to look very carefully at it and consider how it might benefit patients here.

The third question was about the global tech industry. I covered that off a little by saying how we plan to set out our big challenges and then say, “This is the innovation that we need you to come up with.” Of course we want to drive local innovation too, so if there are particular local challenges, we want to empower integrated care systems and integrated care boards to encourage local businesses and local innovators to come up with solutions to supply their local NHS.

My hon. Friend’s final question was about the ability of the MHRA to deliver. I referred to the £10 million. We have also recently increased the fees for the MHRA, which come directly from industry, because it is largely self-funding. I keep a real watchful eye on this. I regularly meet the chief executive officer and others from the MHRA. I have also visited the MHRA twice, which was fascinating. If anyone has not done so, I encourage them to arrange a visit with Dr June Raine; I know she would be very happy to set that up. It is an absolutely fascinating place, based in South Mimms.

In conclusion—I am conscious of time and I know that my hon. Friend would like some time to respond—I again thank my hon. Friend for securing this important debate. Dare I say that this is probably not an issue being discussed widely around dinner tables across the country? Nevertheless, it is of vital importance to UK plc, it is hugely important to our NHS, and of course it is really important to patients, too.

This afternoon, my hon. Friend has drawn on her personal experience as a former Health Minister and a former Digital Minister to highlight the importance of medtech, and in doing so she has done her constituents and patients across the UK a huge service. I very much look forward to working with her and others to seize the opportunities and break down the barriers, so that we can bring the very latest innovation to patients as quickly and as safely as possible.

[Sir Gary Streeter (in the Chair)]

Dame Caroline indeed has the final say.