Draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
Debate between Caroline Johnson and Andrew Gwynne(3 weeks, 6 days ago)
General CommitteesRead Full debate Read Hansard Text Read Debate Ministerial Extracts
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)
Commons ChamberRead Full debate Read Hansard Text Read Debate Ministerial Extracts
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.