Medical Technology Regulations and the NHS

Jim Shannon Excerpts

Tuesday 28th March 2023 Westminster Hall

[Dame Caroline Dinenage (Gosport) (Con)]

I beg to move,

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.

[Jim Shannon (Strangford) (DUP)]

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.

[Dame Caroline Dinenage]

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.

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.