Draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
Debate between Caroline Johnson and Andrew Gwynne(3 weeks, 6 days ago)
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Andrew Gwynne
I thank the hon. Lady for her valuable contribution. These regulations introduce clearer, more robust requirements for post-market surveillance of medical devices, to improve patient safety and to signal a crucial shift in the way in which we manage medical devices in Great Britain.
The hon. Lady raised some important points. First, on the MHRA and whether it is appropriately resourced to cope with the likely increase in incident reporting as a result of this regulatory change, let me reassure her that the measures introduced in this instrument should not have a significant impact on MHRA capacity. Its systems and processes to provide regulatory oversight for vigilance reporting are already in place. The measures within this statutory instrument are expected to increase the volume of safety data reported to the MHRA. However, the accompanying improvements to data quality will support automation and reduce burdens associated with data analysis. To ensure that the MHRA’s systems for vigilance reporting are fully equipped to handle the new reporting requirements for manufacturers, we will verify system-readiness through comprehensive testing and validation ahead of the date of application of these regulations.
As the regulator for the whole United Kingdom, the MHRA is committed to protecting patient safety while enabling a regulatory environment in which the life sciences sector is able to innovate and to launch new medical products in the interests of public health across the UK. Contrary to the hon. Lady’s assertion that the regulatory burden will be increased and will therefore squash innovation, the opposite is the intention of this Government. The intention is to ensure that there is a clear regulatory framework throughout the United Kingdom—without having the disparities that we have at the moment—and to ensure that better, smarter use of the data will be available. The closer scrutiny of the efficacy of these medical devices will encourage innovation in medtech and in life sciences.
Dr Caroline Johnson
The Minister is saying that more regulation will encourage innovation. I am not sure I agree with that premise, but does he accept that these new regulations will lead to a higher regulatory burden on people wanting to set up medtech companies in the UK than in the EU or elsewhere?
Andrew Gwynne
We could get into a theological debate about the benefits or otherwise of regulations, but this statutory instrument will provide certainty and clarity across all four nations of the United Kingdom. It will provide a known framework for medtech and life science companies operating, or wishing to operate, in the UK. I see this as a good piece of secondary legislation to bring about the certainty that we want to give companies wishing to operate, or which are operating, in the United Kingdom, and to set up a common framework across our four nations. I see that as good. Regulatory divergence with another part of the United Kingdom is not, in my mind, good for business—particularly where a company wants to operate on both sides of the Irish sea.
On patient confidentiality and the cost estimates for the NHS, I hope the hon. Lady will forgive my having to write to the Committee on that point because the tablets of stone have not yet reached me from Mount Sinai.
On the hon. Lady’s question on innovation being reversed and whether people have long enough to prepare, we believe that the measures in the statutory instrument do give people long enough to prepare—not least because many of those companies are already operating in the parts of the United Kingdom that the instrument will bring our regulation in line with. Therefore the extra capacity that is needed in the system will not be to the detriment of the measures in this statutory instrument.
Dr Johnson
Parts of the UK are working to EU regulations, but does the Minister recognise that the statutory instrument he is bringing forward will introduce into the whole of the UK market, regulations that are not currently present in either the UK or EU markets?
Andrew Gwynne
I recognise that we are not only bringing Great Britain in line with Northern Ireland but adding other patient safety measures. If the hon. Lady is saying—I hope she is not—that the result of the Cumberlege review is that we do nothing in this area to improve the issues highlighted by it, she is within her powers to oppose these measures. However, we think not only that ensuring regulatory consistency throughout the United Kingdom is the right thing to do, but that this statutory instrument gives us the opportunity to start to put right some of the shocking, appalling things that we know have happened, as highlighted by the Cumberlege review. That is what these measures seek to do.
This Government are committed to the delivery of a framework for medical device regulation that prioritises patient safety—that is the crucial thing that we are seeking to do—and that gives patients access to the medical devices they need, and ensures that the United Kingdom remains an attractive market for medical technology innovators. We have an obligation to patients and the public to maintain the highest standards of safety and efficacy for the medical devices they rely on. These regulations are an important first step to deliver this framework, and they place patient safety at the forefront. They will enable not only the MHRA but the whole health system to better protect patients.
I am grateful to the hon. Lady for her contribution, and to Members across the Committee for considering these regulations today. I hope they will join me in supporting these regulations, so that we have consistency across the UK and put patient safety at the heart of medtech and life sciences.
Question put and agreed to.
Oral Answers to Questions
Debate between Caroline Johnson and Andrew Gwynne(2 months, 1 week ago)
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Andrew Gwynne
I have every sympathy with the case that the hon. Gentleman has put forward. This Government want to see a shift of health services from hospital to community, from analogue to digital, and from sickness to prevention, but these decisions are not taken through inertia; they are taken because of the Government’s inheritance from the Conservative party. We have had 14 years of running down our health services, with needless reorganisations that have destroyed and set back the progress that the last Labour Government made on the NHS. This Government will fix the NHS, including in the hon. Gentleman’s local area, but he has to recognise that the root cause of many of the problems faced by Members across the Chamber lies at the feet of the former Secretary of State and the last Government.
Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
We have heard about the challenges facing Whipps Cross hospital. The Secretary of State’s decisions to pause capital projects across the country and put them under review has caused worry and uncertainty for staff in hospitals nationwide. Can he say when the review will be completed, so that we have certainty about when things will go ahead?
Andrew Gwynne
The review will be completed when all the information has been analysed. The hon. Lady should not just be a little more patient; she should be a little more apologetic for the fact that the Government found a hospital rebuilding programme that was not worth the paper it was written on, because the ultimate paper we needed—the cash—was not there.
Local Government and Social Care Funding
Debate between Caroline Johnson and Andrew Gwynne(5 years, 7 months ago)
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Andrew Gwynne
The Minister says it went up, but actually it confirmed what many of us feared, because under this Government there will never be an end to the pain of austerity. Nothing has changed. Let’s bust this myth. This year’s funding package, while it offered an increase in spending power next year for local government, came with a £1.3 billion extra cut from central Government funding to the revenue support grant. An uplift in spending power has been paid for by local people through increased council tax. That is not fiscal devolution; it is another attempt by this Government to shift the burden on to local taxpayers and to devolve the blame for these decisions to councillors of all political persuasions, including Conservative councillors.
Areas such as the one I represent cannot bring in anything like the resources they need to meet the growing demand for social care and our neighbourhood services through local council tax increases alone. This has left areas with the greatest need unable to mitigate the cuts imposed by the Government and residents paying more in council tax for services to be stripped back even further.
Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
My right hon. Friend the Member for Ludlow (Mr Dunne) made the point that the last Labour Government shifted money from the shire counties to the metropolitan areas. The shadow Secretary of State described them as areas of increased need, but does he recognise that in rural areas such as Lincolnshire, where my constituency is, services cost more to deliver because of the geography?
Andrew Gwynne
The hon. Lady makes the case that in rural areas there are greater costs to providing services. In some cases, that is correct, but it is a minority of cases. All the evidence, including in a report commissioned by the Secretary of State’s Department, shows that the opposite is actually true. I do not want to get into an argument with the hon. Lady about how we should cut the cake. The cake is shrinking. We need to grow a bigger cake so that we can share out the slices more fairly. As we continue to shrink the cake, all we do is pit her area against my area and her area’s needs against those of the area I represent.
Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
First, I would like to pay tribute to the fabulous work of the council staff in my area and the local councillors of the Conservative party, independents and others, who work so hard to deliver excellent services for our community.
My right hon. Friend the Member for Ludlow (Mr Dunne) made the point that the previous Labour Government moved funding from shire constituencies to metropolitan areas. As a resident of both South Kesteven and Westminster, I thought it would be useful to illustrate the difference between the two. In South Kesteven District Council area, the average weekly gross wage is £453.20, and the council tax for a band D property is £1,589.38 a year. In Westminster, where I am during the week, the average weekly wage is £786.10, and band D council tax is £710.50. This means that the average person in Westminster is earning more than £300 a week more but pays £879 less in council tax for their local services.
Despite the challenges to funding and the fact that if Lincolnshire County Council were funded the same per capita as the average council in the country, it would receive £116 million more than its current budget of roughly £500 million, it has been able to do some very innovative things with its funding. We have discussed the environment a lot this week. South Kesteven District Council introduced “The Big Clean” initiative last year, which visits each village of the district to remove fly-tipping, clean signs, remove undergrowth and do other things suggested by the local residents to improve the environment in which people live and ensure that they can take pride in their surroundings.
Gravity Fields festival, which has been running since 2012, is an innovation of our local council. This goes beyond delivering the basic services; this is the best in the country. It is a festival of art and science inspired by Sir Isaac Newton, who was from Grantham and went to the local school. The festival not only provides the people of Grantham with information on art and science and very interesting experiences, but it raises £1 million for the local area through visitors staying there and spending their money on food and drink and the like. This is a Conservative council doing its best to deliver really innovative stuff, despite having a stretched budget.
North Kesteven District Council, which covers the other part of my constituency, is similar. It has looked carefully at the challenge of being good to the environment while providing the social housing that is required. It has won awards for building curved homes and passive houses, delivering the next generation of social housing in an environmentally sustainable way. It is not only providing basic services but going above and beyond, to provide excellent services. Lincolnshire County Council receives lower than the average per capita funding, as I have said, but it is still providing our children and young people with what Ofsted describes as “strong and effective” services for those with special educational needs and disabilities.
The ageing population presents one of our nation’s most profound challenges. It raises critical questions about how, as a society, we enable all adults to live well in later life and how we deliver sustainable public services to support them to do so. There will be 2 million more people aged over 75 in the next 10 years, and many of those will be managing long-term conditions. It is vital to make sure that local councils are supported to provide for elderly citizens so that they can age with dignity. That is why I am glad this Conservative Government have invested in social care, with a 23% increase in the improved better care fund to £1.8 billion, an additional £410 million through the social care support grant and £10 billion for adult social care being provided to councils by 2020.
I really welcome the additional resources that have been provided for social care by this Government, but as a Member representing a rural constituency it is important for me to emphasise that an extra £1 for social care in London will go further than an extra £1 in Lincolnshire. Rural areas face higher costs for the delivery of public services than urban areas. [Interruption.] The hon. Member for Denton and Reddish (Andrew Gwynne) says from a sedentary position, “That’s not true”, but if one is visiting an elderly person in their home and then travelling on to visit the next elderly person in their home, there is of course a gap.
Andrew Gwynne
I am not saying that is not true; the Ministry of Housing, Communities and Local Government’s own report says it is not true.
Dr Johnson
I hear what the hon. Gentleman says, but it seems to me that rural shires often have Conservative-led local authorities that provide their services more efficiently. In practice, if we ask a carer to go out to visit three elderly people in a morning, for example, and those houses are very close together, as they may be in Westminster, they will be able to visit, spend longer with them and have lower travel costs than they would if they had to visit three houses in my constituency, which covers 433 square miles and is all within the same county council.
As I was saying, when it comes to social care, this problem is in large part due to both the demographics and the distances involved. As I have said, my constituency spans 433 square miles and has a low population density, and there are longer travel distances for staff to deliver care. Furthermore, Sleaford and North Hykeham, as a rural area, has a higher number of older residents. Those older residents have worked hard their entire lives and now need support from our public services to ensure that they can maintain a higher quality of life.
However, this is not all about funding. Actually, I think it is sad that so much of the debate has focused almost entirely on who is going to provide the most money, while only a little bit has been on how to pay for it, and not so much on innovation and quality of care. The important thing is not shouting about who can spend the most money, but who can deliver the best outcomes and provide the best care for people, because that is surely what everybody on both sides of the House wants.
Last year, there was the launch of the National Centre for Rural Health and Care in Lincolnshire. This is a grouping of the NHS, the University of Lincoln, Health Education England, Public Health England and the East Midlands Academic Health Science Network. This pioneering group will look at improving how we deliver care in local areas.
There is also the social care and digital innovation programme, which is run by NHS Digital. This gives money for local projects, so somebody with a local project that they think could improve care for residents, if they had a little bit of start-up funding to test it, could receive money to support the design and trial of digital solutions to improve care and provide value for money. Previous projects include an exoskeleton device in the Isle of Wight to give people greater independence, and the provision of Amazon Alexa in Hampshire to help people to maintain independent living.
There are other projects, too. In Cornwall, Peninsula Community Health Services is looking at how to prevent pressure sores. We know that 500,000 people in this country develop a pressure sore every year. These are excruciatingly painful, can become infected and, in the worst cases, can lead to such a serious infection that the patient dies. The continuous pressure monitoring technology devices will be able to help people identify hotspots even before the skin damage occurs and prevent that from happening. That is an investment in something that, overall, will not just improve patient care but save money.
The Leeds Care Record looks at how information can be shared—data protection means that in some cases it is difficult to share information held by hospitals and GPs—and how referrals are made. When I first qualified as a doctor, all the letters were dictated and signed, but now they are typed and sent electronically. Cumbria, for example, saves £400,000 a year by sending referrals electronically. That also saves time, which means not only saving money but improving the efficiency of the service delivered to patients.
I am glad that the Government acknowledge the need to change the outdated funding formula, which has failed accurately to recognise the discrepancy in need between urban and rural areas; that need is often hidden in rural areas. As Ministers review the consultation findings, I hope they will ensure that the new funding formula adequately takes that into account.
Finally, as a member of the Conservative party, which has long been the best custodian of the public finances, I say that it is imperative that money is spent both wisely and efficiently. The issue of social care goes much wider than just funding. Despite the challenges facing local councils, I have seen at first hand how the brilliant work by North and South Kesteven District Councils and Lincolnshire County Council can support the people in my constituency and make our resources go as far as possible.