That this House has considered medical technology regulations and the NHS.
It is a great pleasure to serve under your chairmanship, Sir Gary, and to talk about the importance of medical innovation and medical technology in our NHS. We know that the NHS faces significant challenges, but medical technology—or health tech, as it is often called—holds many of the solutions that are necessary to achieve things such as delivering improved patient outcomes and facilitating the transition to more sustainable models of health and care delivery. It also has massive potential to drive economic growth.
Health tech includes everything from laboratory tests to wound care dressings, mental health apps, implantable defibrillators and critical technology—everything that is absolutely fundamental to the diagnosis and treatment of health conditions. Life-saving and life-enhancing health technologies, such as cardiac pacemakers and artificial knees and hips, are already highly regulated products. While we were part of the EU, UK-based health tech was subject to CE marking, but now there is a need to develop sovereign regulatory arrangements that provide equal levels of patient safety while protecting timely access to global life-saving and life-enhancing health technologies.
The Medicines and Healthcare products Regulatory Agency is solely responsible for regulating the UK’s medical devices market and is mandated to ensure that patient safety is protected, irrespective of where a product is manufactured. The MHRA has a huge responsibility on its shoulders, and it is for that reason that I welcome the Chancellor’s commitment in the spring Budget to reform regulations around medicines and medical technologies. In fact, that was the thrust of why I asked for this debate, so it is lovely to be able to welcome that announcement rather than to be pushing for it. It is a much more comfortable position for me to be in.
The Chancellor confirmed that the MHRA will receive £10 million of extra funding over two years to maximise its use of Brexit freedoms and accelerate patient access to treatments. He also confirmed that the MHRA is moving to a new model, which will allow near automatic sign-off for medicines and technologies that have already been approved by trusted international partners in places such as the USA, Japan and Europe. That is important, because the US Food and Drug Administration—the FDA—is recognised as delivering high-quality, innovative health tech to its citizens in a timely manner while maintaining high standards of patient safety. Those product regulation-equivalent routes, which recognise the decisions of trusted jurisdictions that have already looked at medicines and technologies very carefully, can protect NHS patients’ access to high-quality products and allow our own regulator to focus resources on where they can make the most impact.
I thank the hon. Lady for bringing this issue forward, and I apologise to her and others for not being able to stay—I have another meeting at 5 o’clock, as I mentioned to you, Sir Gary.
I am my party’s health spokesperson, so I am very aware that regulation is essential to our health service. I strongly believe that regulation and demand should go hand in hand on health. Regulating the use of apparatus, instruments, tools, scanners, drugs and monitors is one thing, but does the hon. Lady agree that accessing them is another? It is imperative that we ensure that patients can make use of life-saving treatments. Aspiration is good, but delivery is better.
It is always a great pleasure to see the hon. Gentleman, who always make very sensible interventions on these issues. He is absolutely right: we need the right regulation in place, but we also need to have the facilities to make sure that, once technology and treatments have been approved, they are easily and quickly accessible to those who most need them.
I will be the first to admit that I was not the biggest advocate of Brexit. However, the freedoms afforded by Brexit allow us the opportunity to recognise approvals from any jurisdiction that we deem appropriate. Of course, any products that enter the UK market via regulatory equivalence routes from trusted international jurisdictions will need to be approved by the MHRA and to be subject to strict vigilance and post-market surveillance requirements, so a number of checks and balances are in place for British patients. However, this new system post Brexit gives the UK more control to determine what products can be placed on the market.
As the hon. Member for Strangford (Jim Shannon) said, we must ensure that the regulatory system is robust but also prevent the UK from becoming a secondary market, where patients and clinicians have less access to technologies. The right system not only increases the UK’s access to the newest innovations but increases patient safety by maintaining access to the widest possible range of thoroughly regulated and already available health technology from around the world.
Therefore, my first question to my hon. Friend the Minister—I should warn him I have two or three—is whether he can confirm the timescales for the new model to ensure continued patient access to health tech and whether there will be a sense of urgency about this. The Minister and you, Sir Gary, will know that the pandemic, through the early innovation of the vaccines and the remarkable work done by British scientists, demonstrated the UK’s ability to be a real science and technology superpower. However, there is an urgent need for action to ensure that we do not lose the opportunity to impact patients’ lives and effectively deliver on this ambition and this ability.
I am grateful to the hon. Member for Gosport (Dame Caroline Dinenage) for securing today’s debate, and for the manner in which she summarised the case. I may disagree with her optimism on the Brexit side, but I think there is a lot here that we can agree on.
This issue is of great concern to all our nations. Medical devices are used in the diagnosis, treatment and management of a wide range of diseases and conditions. Across these islands, it is estimated that one in 25 people has an implanted medical device. The regulation of medical devices is reserved to the UK Parliament and regulator, and the Medicines and Healthcare products Regulatory Agency covers all medicines and medical devices used in the diagnosis and treatment of illnesses. Under the current UK regulations, manufacturers must report any adverse issues involving medical devices to the MHRA.
In the Scottish context, Health Facilities Scotland assists the MHRA in providing technical and operational support to the Scottish Government health and social care directorate, and to NHS Scotland. In February 2018, the independent medicines and medical devices safety review was launched to investigate how the health system responds to concerns about the safety of treatments. The review, chaired by Baroness Cumberlege, focused on vaginal mesh, sodium valproate and hormone pregnancy tests. The review’s report, published in July 2020, made nine recommendations. My colleagues in the Scottish Government have committed to implementing all the recommendations of Baroness Cumberlege’s review, including the appointment of a Scottish patient safety commissioner.
As we have heard, patients, families and campaigners brought to light those horrific medical disasters: the use of the hormone pregnancy test Primodos; the use of the antiepileptic drug sodium valproate in pregnancy; and the use of vaginal mesh. It is clear that the same underlying issues have driven all three disasters. There were four main features: a failure of licensing and regulation in the first place, particularly regarding implantable devices, such as vaginal mesh; a lack of accurate information to enable doctors to discuss the risks of those devices and allow patients to give informed consent; a weak system for doctors or patients to report the adverse events, which would have resulted in action; and, in some cases, a failure of doctors to listen to the affected women who raised concerns.
It is a pleasure, as always, to serve under your chairmanship, Sir Gary, especially now that this radiator down at my ankles is working. It is also a pleasure to contribute on behalf of the Labour Front Bench in this important debate.
I commend the way in which the hon. Member for Gosport (Dame Caroline Dinenage) presented the case for medical technology. She is absolutely right, because whether it is diagnostic or surgical devices or the digital tools that assist us in making healthcare more accessible, medical technology underpins much of the work that the NHS does. It is also, as has been highlighted in this debate, a key contributor to the UK economy. Medtech generates an annual turnover of over £27 billion and provides around 138,000 jobs. The importance of supporting and, indeed, turbocharging this sector cannot be overstated.
Labour has been clear that it wants to see Britain leading medical science and technology on the world stage. That ambition will be at the heart of our 10-year plan for change and modernisation, which will revolutionise care in this country, transforming our healthcare system from one that just treats the symptoms of illness to one that addresses the root cause of ill health. Imagine a country where we could get out into communities and harness new technology to spot cancer cases early or support individuals at potential risk of developing rare diseases—a country where, using genomics, we do not just treat illnesses such as cancer, diabetes and heart disease, but predict and prevent those conditions.
All that might sound a little far-fetched or sci-fi, but the technology to do it exists in British laboratories and research centres today, and it is ready and waiting to be realised fully. It is therefore extremely welcome that the Government have finally published their medical technology strategy. That is an important step in better utilising this sector, but it must be followed up by concrete action. Crucially, it must come alongside targeted work to reduce waiting times and the elective care backlog. I note that the strategy states that medtech will help the NHS to use
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 start by thanking the Minister for so comprehensively answering all my many questions and for showing his huge commitment to and understanding of this issue. It is a bit technical, as he said, but it is very reassuring to know that we have a Minister in place who gets it. It is also reassuring to know that we have a Chancellor in place who, like myself, was in a digital role and in a health role for many years, and really understands this issue and has a desire to put the weight of the Government behind it to make sure that we get it right.
The medtech strategy is a great starting point; we just have to make sure that we do not let it lose impetus. We have to build on it and make sure that it really delivers its potential in terms of saving lives, improving people’s quality of life and health outcomes, and immeasurably impacting people’s experiences in our NHS. However, as the Minister and the Opposition spokesman, the hon. Member for Denton and Reddish (Andrew Gwynne), both said, the strategy also has massive potential for our economy, nationally and regionally.
In fact, the Opposition spokesman summed things up really well when he talked about some of the technology; is seems almost unimaginable or something from a sci-fi movie, but it is out there already, and we need to be nimble and agile, and lean in to harness its potential. We just have to do everything we can to ensure that all the obstacles that would stand in the way are removed. We all know that prevention is better than cure, and we now have technology on our side that can really ensure that that prevention happens.
The Minister said that this is not a subject for conversation around dinner tables. I know that it is wildly technical, but some of its implications are the sorts of things that people talk about around their dinner tables. If one was able to predict whether one might be susceptible to developing dementia, would one want to know? Those are the sort of moral and ethical questions and conversations that people have. In many ways, people may feel that they would not want to know. In other ways, however, if people could make lifestyle interventions that would prevent or delay the onset of dementia, they might want to know. And if we could then monitor those people and conduct the clinical trials and observations that may lead us to find cures that change immeasurably the lives of both those living with dementia and their families, that must be worth embracing.
5:15 pm
Sitting adjourned.
We have the potential to make the United Kingdom the most attractive place in the world for innovation and, in particular, medical innovation. We know that medical technology helps to deliver better patient outcomes, improves care pathways, drives cost savings in the NHS, reduces the burden on the workforce and, critically, can help to reduce the backlogs. This matters to people’s lives. In the Hampshire and Isle of Wight integrated care board area, more than 54,000 people are waiting to start treatment. The average time people are waiting in my local area to start their treatment is 16.9 weeks, with 47% of patients waiting more than 18 weeks. That is why we need to capture the potential of every way possible of ensuring that people get access to treatments as effectively and quickly as possible.
In Gosport, 1,500 people have a dementia diagnosis. Dementia is one of the biggest healthcare challenges facing us as a nation, but there are some exciting and innovative developments there too. The EDoN—Early Detection of Neurodegenerative diseases—project will use wearable tech to detect signs of dementia even 10 to 15 years before symptoms appear. Too often, a dementia diagnosis comes far too late—once symptoms are already well advanced. This technology could be game changing by allowing people to make advance lifestyle interventions that might minimise the impact of the condition. However, it will also enable scientists to make a huge contribution to research and clinical trials of drugs and interventions that will work, inevitably in the long term, through to treatments and cures.
This is also an area where we need to see the rapid approval of new treatments as they become available. In January, the FDA—the US regulator—approved the first treatment shown to slow degeneration in dementia. Two drugs are currently on trial in the UK, and the people conducting the trials expect to publish their findings later this year. Neither drug has an easy name to pronounce: donanemab and lecanemab. Can the Minister please assure me that the MHRA stands ready to accelerate the approval of these schemes as soon as they become available—it sounds as though one is imminent; it may be in the next couple of months—so they can start supporting patients at the earliest opportunity?
If I may just flag one issue with the Minister, one obstacle to these drugs being available on the NHS is the National Institute for Health and Care Excellence guidelines, which often approve medicines based on their cost-effectiveness. In this case, it will be remaining years of healthy lifespan versus the cost to the NHS. The cost of dementia is of course largely not borne by the NHS—the cost to it is only about £1.5 billion a year, compared with the £26 billion borne by the adult social care system and the informal care sector.
Will the Minister kindly agree to meet Alzheimer’s Research UK to discuss how we can best ensure that UK patients get swift access to the best possible dementia drugs as soon as they are available and that the systems designed to offer checks and balances, such as NICE, do not prove to be an obstacle to that?
Will the Minister assure us that every effort will be made to engage with the global health tech industry to ensure that the UK proactively seeks innovations for the benefit of UK patients while encouraging UK-based innovation? There is a lot of innovative practice going on right under our noses. Health tech will play such a key role in driving not only UK national economic growth but great amounts of regional growth. There is an organisation called SIGHT, or Supporting Innovation and Growth in Healthcare Technologies, which is a business support programme developed by the University of Portsmouth to provide help and guidance to small and medium-sized businesses in the healthcare technology sector. In the Wessex region, which is where Gosport sits, 10% of the workforce is employed in the health economy, and more than 300 health and life sciences companies are focused on medical technological innovation. The SIGHT process will provide an important boost to the regional economy through its support for the sector. What steps is the Minister taking to encourage local innovation and entrepreneurship in the medical technology sector, and how can he enable the implementation of innovation in the local care system, which can sometimes be quite risk averse?
To maintain the NHS’s access to the 600,000 currently available CE-marked products, it will be important not to add unnecessary burdens on to manufacturers that already supply a relatively small market, so transitional arrangements provide for a dual regulatory regime, with the unilateral recognition of CE marking in place until July 2024, subject to legislative approval. That recognition could be continued and expanded for the benefit of the NHS and patients across the country. Perhaps the Minister could talk a bit about that.
We need to act fast. A recent survey by the Association of British HealthTech Industries—the ABHI—shows that one in five products is expected to be removed from the market over the next five years, and one in 10 companies is halting all innovation activity. That has been driven by persistent uncertainty, constrained capacity in the system and increasing costs. The ABHI survey also highlighted that 67% of the health tech industry expect a delay in bringing innovation to the UK, and the figure rises to 86% for those manufacturing in vitro diagnostic medical services.
The right kind of regulation will be key in setting the standard as to whether the UK is an attractive place to do business and promote innovation. It will ensure that UK patients continue to receive world-class technologies such as surgical robots and digitally enabled remote care, and it will protect our ability to react swiftly and effectively to any further pandemics by developing the latest diagnostic tests.
In addition, I understand that the Government are already committed to a medical device information system. That will collect key details of the implementation of all devices, which will be linked to a specific register to research and audit patient outcomes. That will deliver a system that allows the UK to record and access device safety and patient outcomes. That medical device roadmap lays out an ambitious vision for how the UK can become world leading in this space and a real global superpower in digitally enabled health tech. Will the Minister assure us that its delivery will be prioritised to ensure that we build on the positive reaction to its publication?
There are concerns that existing capacity constraints may impact the MHRA’s ability to deliver and most effectively use the additional funding that the Chancellor has made available. Making the most of expertise and capabilities across the ecosystem will be crucial. As well as the development of more product regulation equivalence routes to allow for the recognition of approvals in other trusted jurisdictions, we must explore all other options to ensure the expansion of existing capacity, including by reviewing the role that the MHRA can take in direct regulation, providing it with both the resource and political impetus to increase UK regulatory ambition, and enabling the development of recognition and innovation systems.
The recent commitment by the Chancellor and the Prime Minister is welcome, and it indicates that the Government truly recognise the need to ensure that there is appropriate focus and support for the ambitious innovation programme that supports clinical and patient need, availability, and choice. It is by investing in developing the skills required that we can ensure that the UK continues to be a leader in regulating the technologies of the future.
The freedoms afforded by Brexit allow us to seize the once-in-a-generation opportunity to deliver a best-in-class regulatory system and enable the health tech industry to support the drive for the UK to become, and continue to be, a global science and technology superpower.
Health technology, medical devices and equipment are crucial in delivering services in NHS Scotland, and they must meet clinical and information governance requirements to minimize the risk of adverse events. To provide high-quality patient care, medical technology must be procured, managed and maintained appropriately. Although the regulation of medicines and medical devices is currently a reserved matter for the UK Government, the Scottish Government support ongoing reform of the assessment of medical device safety. However, there are concerns that the UK Government intend to compound the Brexit harms in the NHS by removing many European standards and regulations from the statute book with their Retained EU Law (Revocation and Reform) Bill.
The Scottish Government are concerned about the impact of the UK’s departure from the EU on the regulation of medicines and medical devices. The Scottish Government believe that regulatory reform must include the systematic incorporation of patients’ experiences in decision making. There have been shortages of medicines since the UK’s departure from the single market, and they have resulted in price increases and the use of serious shortage protocols. It will come as no surprise that the SNP opposes the Retained EU Law (Reform and Revocation) Bill, which could remove important protections, such as food labelling, animal welfare, and environmental controls. Scotland wants to maintain EU standards for medication safety and controls.
“fewer resources…through informing effective healthcare purchasing, championing sustainability, embracing innovative technology and improving health data”.
I do not disagree. We must maximise the use of medtech across the NHS. It is not a party political point; it is a common sense one for the future.
For medtech to realise its full potential, we need staff—an area on which the Government have had little to say. I am hoping that something will come in the weeks ahead. In fact, the Government have the opportunity to nick Labour’s workforce strategy; they did not do it in the spring Budget, but I am sure the Minister is on the case.
Put simply, there is no one silver bullet to solve the crisis in our NHS—we need a whole-system approach—but medtech has a massive role to play in the future. What does a whole-system approach mean? It means giving the NHS the tools, staff and reform it needs to survive. Without all three, we will not be able to rebuild our health system, which is sadly under enormous pressure right now.
With regard to the strategy, I would appreciate some clarity on a few points from the Minister in his response. The first relates to the adoption routes for new technologies. The Health Tech Alliance estimates that it takes approximately 17 years for a device to be adopted into the NHS. The Government strategy mentions adoption rates, but it is relatively light on detail. If new technology is safe and effective, we should be doing everything we can to get it into the hands of NHS clinicians. What further work is he planning to undertake in that respect, and will he provide more detail on how he plans to improve technology adoption rates?
I will touch on regulatory requirements, which the hon. Member for Gosport mentioned, and the speed with which we get new treatments to patients. Last year, we had an agonising to and fro over the pre-exposure prophylaxis Evusheld. The drug was designed to protect those who are acutely vulnerable to covid-19 and still shielding, but the process for approving it for use in the NHS took far too long. By the time the drug had been fully reviewed, it no longer responded as effectively to covid variants, and it was therefore not recommended for use.
NICE recognised that fact in recently published guidance, and it has committed to developing a new review process to streamline approval for covid-19 treatments. Has the Minister had any discussions with NICE on the timeline of that process, and what action is he taking to ensure that future safe and effective treatments and technologies do not face similar regulatory delays? Similarly, with unwelcome reports that the antivirals taskforce is being wound up at the end of this week, what steps is he taking to ensure that suitable provision of those essential treatments continues?
Finally, I will press the Minister on small and medium-sized enterprises. A recent study found that up to 24% of UK-based health tech SMEs are now looking to launch their innovations outside the United Kingdom. That would be a travesty, and I am sure it concerns him as much as it concerns me, the hon. Member for Gosport and the SNP spokesperson, the hon. Member for Linlithgow and East Falkirk (Martyn Day). The UK should be empowering home-grown tech, not missing out on it because of neglect and miscommunication. Despite the problem, the medical technology strategy made little reference to SMEs, aside from saying that the Government would support improved management of SMEs and upskilling of workers. That is just not good enough for companies that make up 85% of the medtech sector.
What more is the Minister doing to ensure that SMEs are sufficiently supported to launch their innovative new products here in the United Kingdom? I appreciate that he will be required to work across Departments to ensure that this growing sector, which has so much potential to grow further, is as supported as we would expect. What more can be done to streamline the regulatory processes that many SMEs are grappling with?
To close, we need to ensure that Governments of whatever political colours are not too slow to harness the medical technology sector. If we are, ultimately it is patients—the people we are sent here to represent as Members of Parliament—who pay the price. We need to build an NHS that is fit for the future, where patients are seen on time and technology is employed to tackle ill health and inequalities. That is something that I and the Labour party support, and I suspect the Government will say they support it too. Let us just get on with it.
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.
One of my big concerns is that we just do not adopt these technologies and innovations early enough, and that we certainly do not get them into the NHS early enough. There is a whole raft of issues around risk aversion and proving cost-effectiveness, and local areas wanting to be early adopters of innovation. We have a load of obstacles to overcome, but I am really grateful to the Minister for setting out his stall and articulating how we are going to tackle this issue.
Question put and agreed to.
Resolved,
That this House has considered medical technology regulations and the NHS.