Draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
(1 day, 14 hours ago)
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The Parliamentary Under-Secretary of State for Health and Social Care (Andrew Gwynne)
I beg to move,
That the Committee has considered the draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
It is a pleasure to serve under your chairmanship, Mr Efford. I will begin by setting out the policy context for the regulations.
The 2020 independent medicines and medical devices safety review, led by Baroness Cumberlege, highlighted the consequences of inadequate post-market regulations for patients, especially women, who received pelvic mesh implants. The review found that the system often failed to listen to patients’ concerns and acted too slowly when issues were identified. Those women have suffered horrendously as a result. The review called for substantial changes to the Medicines and Healthcare products Regulatory Agency, the MHRA, to ensure patient safety, including improved regulation of medical devices to enhance the collection of adverse incident data to reduce patient safety risks and prevent a recurrence of harm.
This statutory instrument will deliver improved safety for patients. It will introduce clearer and more robust requirements on medical device post-market surveillance—PMS—so that manufacturers are required to collect and evaluate the safety and performance of medical devices in a thorough and consistent manner, once they are in real-world use.
What will this mean for patients in the UK? This instrument represents the first step in a series of amendments to reform the Medical Devices Regulations 2002. These changes are designed to enhance the safety of medical devices, to ensure availability and to support innovation.
This instrument will create a strong foundation for this medtech regulatory reform and deliver patient benefits in three key areas—first, by improving patient safety. This instrument will not only enable the MHRA, but the whole health system to better protect patients by more closely monitoring the safety and performance of medical devices. This includes medical devices within the NHS and in our local communities, thereby supporting the Government’s mission to shift focus from hospital to community. This will result in more rapid identification, investigation and resolution of safety issues, allowing the NHS to focus its resources more effectively. While doing so, these regulations will also strengthen the patient voice by requiring manufacturers to undertake patient and public engagement where appropriate during their post-market surveillance.
Secondly, this statutory instrument will provide stronger assurance that devices supplied to the market are safe and effective, supporting both the continuation of supply, and improved access for the NHS and patients to potentially transformative technologies. With stronger assurance of safety and efficacy, we are able to implement new routes to market. For example, this instrument will help support the introduction of an international reliance framework, taking into account, where it is safe to do so, decisions made by comparable regulators. We intend to lay that draft legislation in 2025 as part of future medical devices regulatory reform.
Finally, this instrument will support innovation and economic growth by providing regulatory certainty for manufacturers considering placing their medical devices on our market. The collection of real-world data can result in more user-friendly and more effective innovations by highlighting opportunities for improvement, ultimately achieving better outcomes for patients.
I will now take a moment to summarise the key provisions of this instrument. Once in force, this statutory instrument will ensure that any medical device placed on the Great Britain market is subject to rigorous post-market scrutiny. This will enhance patient safety across the board, thereby promoting a consistent approach to PMS throughout the UK, where of course Northern Ireland has its own arrangements. This statutory instrument will set out in greater detail what must be included as part of a PMS system and a PMS plan. Manufacturers will need to ensure that their PMS system includes analysis of relevant data throughout the medical device's lifetime.
This comprehensive approach allows for a more accurate assessment of device performance, ultimately leading to faster identification and resolution of safety issues. This statutory instrument will provide greater detail on when and how to report serious incidents. The timelines for notifying the MHRA will be standardised throughout the UK, benefiting manufacturers that supply medical devices to both Northern Ireland and Great Britain and ensuring that safety issues are identified and investigated promptly.
The introduction of new requirements to share summary reports at regular intervals means that medical devices will be continually monitored to ensure their performance, with higher-risk devices facing even more scrutiny. These measures encourage manufacturers to monitor both serious and non-serious incidents over time, which will aid recognition of adverse safety trends and signals, supporting the containment of potential safety issues before they escalate.
I commend these measures to the Committee.
Dr Caroline Johnson (Sleaford and North Hykeham) (Con)
It is a pleasure to serve under your chairmanship, Mr Efford. I think we all understand the context of the IMMDS review. Having spoken on Sunday afternoon to a lady who is suffering having had a mesh put in—the skin has never healed over the top and she is facing difficulties—I fully understand the reasons for the regulations. We all want safety; we all want the equipment that doctors like me use to be safe. We also all want support for the science and technology sector, and we all want people in the UK to have early access to the very best new medical devices. As such, the importance of the regulations is not just that they are there and they are strong, but that they are proportionate and effective in their aims. I have a few questions in regard to that.
First, the MHRA will be sent lots of data—reports on 3 million medical devices at one, two and three-year intervals, depending on the type of device. Is the MHRA required to look at that data, or to check whether manufacturers are required to produce these reports, or even to check that manufacturers have produced these reports? If it does have such a requirement, does the MHRA have the resources to look at all this extra data and to review it? If it does not have such a requirement, what is the point?
The cost estimate in the impact assessment talked about £310 million over 10 years, but for 3 million devices that does not seem particularly high. Six months is being given for these regulations to become legally enforced. Is that long enough for businesses to prepare and for the MHRA to get ready to look at this?
How much of this cost will be passed to the NHS, and how much has the NHS budgeted for such costs? How will the NHS comply with the legal requirement to get patient experience data? The Minister talked about the importance of getting patient experience data where appropriate, so what will the exemptions be? If someone was having a Guedel Airway put in, they would probably be unconscious and might not be aware of how effective the device was—if they woke up it would probably be more effective than if they did not, I suppose, but it is quite difficult.
Confidentiality is also an issue. If a medical device like a new hip is being put into somebody, will the Government provide information to manufacturers on who has got their hips, or is the manufacturer expected to guess? Or is the NHS expected to act as a go-between, and if so, how will that work in practice?
The regulations are also a bit of a burden on small businesses. I notice the Government have made the decision, as evidenced in the impact assessment, to include all small businesses—even micro-businesses—under these regulations. Has the Minister considered whether that will incentivise businesses to set up elsewhere, in Europe or overseas, reducing UK innovation and reducing the likelihood that manufacturers will apply for a UK Conformity Assessed mark because there is more regulation in the UK than elsewhere? Will that delay access to new devices for our patients in this country? In particular, the “similar devices outside of GB” requirement requires even the smallest businesses to find out similar devices’ safety, around the globe. That is possibly something that a large multinational corporation could do, but a micro-business in, perhaps, Oxford or elsewhere would find it difficult to find all that information. The cost proportional to the business will be extremely high, which will reduce the number of new people entering the market.
Overall, the Government have the right intention to provide for patient safety. However, the longer period that safety has to be viewed over and the additional regulation compared to the European Union mean that, once again, the Government have chosen to take an EU regulation and gold-plate it, to the detriment of Britain, and ultimately potentially that of patients.
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.
Draft Persistent Organic Pollutants (Amendment) Regulations 2024
(1 day, 14 hours ago)
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The Parliamentary Under-Secretary of State for Environment, Food and Rural Affairs (Emma Hardy)
I beg to move,
That the Committee has considered the draft Persistent Organic Pollutants (Amendment) Regulations 2024.
It is a pleasure to serve under your chairmanship, Sir Roger. This statutory instrument, which was laid before the House on 8 October, adds three additional substances—UV-328, dechlorane plus and methoxychlor —to the assimilated persistent organic pollutants, or POPs, regulations in response to the adoption of those three substances as POPs under the United Nations Stockholm convention. The UK is a party to the convention and is therefore obliged to reflect in UK law the listing of POPs under the convention.
In addition, the instrument makes a number of other technical changes to the annexes of the POPs regulation. Those include changes to waste concentration limits, specific exemptions and unintentional trace contaminant levels, or UTCs, for some POPs. In brief, the amendments update and clarify how some articles, substances or mixtures containing some POPs can be used, manufactured, placed on the market or disposed of. This legislative change is permitted by use of the powers available within articles 7, 15 and 18 of the assimilated EU regulation on POPs. We have worked with the devolved Administrations on this instrument.
POPs are substances recognised as particularly dangerous to the health of humans, wildlife and the environment. This instrument preserves and adds to the current regime for managing, restricting or eliminating POPs in the UK. Some of the regulations in this amending instrument are needed to implement the UK’s commitments under the United Nations Stockholm convention on POPs. The majority of amendments are informed by updates to the Stockholm convention and, in some cases, have come about following updates to the Basel convention guidance on the management of POPs waste, and following consultation.
Let me turn to the details of the instrument. At the 11th meeting of the conference of the parties, held last year, a decision was adopted to add three new substances called UV-328, dechlorane plus and methoxychlor to the list of substances for global elimination under the convention; this decision was communicated to parties by the UN depository in February 2024. This instrument adds those new POPs to the list of substances prohibited by law from being manufactured, placed on the market or used in Great Britain.
Secondly, the instrument provides some exemptions from the prohibitions by allowing the unintentional presence of the three substances at trace levels. These limits define the concentrations at which UV-328, dechlorane plus and metho—methox—
Jerome Mayhew (Broadland and Fakenham) (Con)
Will the Minister repeat that, please?
Emma Hardy
I will do my best—by the end of this, I’ll have nailed it.
These limits define the concentrations at which UV-328, dechlorane plus—I got that one—and methoxychlor can lawfully be found in a substance, article or mixture, where they are unintentionally present and found in minimal amounts. Dechlorane plus and UV-328 will also be listed alongside time-limited exemptions for their continued use in specific circumstances. These exemptions are available following agreement by the Stockholm convention’s conference of the parties.
This instrument will make a number of further changes to annex 1 of the POPs regulation, including the addition of a UTC level for two POPs already prohibited in Great Britain. It will also make amendments to the UTC limits and specific exemptions listed for the substance perfluorooctanoic acid, or PFOA, including a provision to phase out or remove exemptions that are no longer required, and the tightening of the requirements regarding a specific exemption for use of PFOA in polytetra-fluoroethylene, or PTFE, micropowders.
Annexes 4 and 5 of the POPs regulation relate to the treatment of waste containing POPs. This instrument will add or update waste concentration limits for several POPs. In practice, those limits specify the concentration at which waste containing POPs must be diverted from landfill to high-temperature incineration or other appropriate disposals, to ensure that the POPs content is appropriately destroyed. Importantly, that includes the introduction of a limit specifically targeted at firefighting foam mixtures containing PFOA—a substance in the poly and perfluoroalkyl, or PFAS, group of chemicals—to ensure the environmentally sound disposal of any remaining stockpiles of these foams.
Finally, this instrument will update the maximum concentration limits for a number of POPs and add decabromodiphenyl ether, or decaBDE, a brominated flame retardant, to the list of polybrominated diphenyl ethers, or PBDEs, in annex 5 of the POPs regulation. Maximum concentration limits set the threshold at which waste handlers can apply to permanently store certain wastes in designated landfill for hazardous waste or salt mines, where it can be demonstrated that destruction is not the environmentally preferred option. The instrument will also add two new European waste catalogue codes to this provision: one for fly ash from peat and untreated wood, and one for soil and stones.
Policy development informing this instrument was subject to a public consultation in 2023. In that consultation, we also stated our intention to prohibit the three new substances once they were adopted for listing under the convention, to implement our international obligations. There have been various opportunities, at both domestic and convention level, for UK stakeholders to submit information regarding the potential prohibition of UV-328, dechlorane plus and methoxychlor, and their potential adoption for global elimination under the Stockholm convention. A de minimis impact assessment was carried out, which concluded that there is no indication that the amendments in the instrument are expected to have an impact on businesses beyond one-off familiarisation costs, and that this instrument is not expected to disproportionally burden small businesses.
The Environment Agency is the delivery body for the POPs regulation for England; Natural Resources Wales and the Scottish Environment Protection Agency are the delivery bodies for Wales and Scotland respectively. They have been involved in the development of this instrument and have no concerns about implementation or resources. The territorial extent and application of the instrument is Great Britain. Under the Windsor frame-work, the EU POPs regulation applies in Northern Ireland. The devolved Administrations in Wales and Scotland were engaged in the development of the instrument and have consented to its being made on a GB-wide basis.
In conclusion, I emphasise that the measures in this instrument are needed, in part, to implement the requirements of the Stockholm convention by adding new POPs UV-328, dechlorane plus and methoxychlor to the list of substances prohibited in Great Britain by law. Other amendments included in the instrument ensure that the POPs regulation is adapted to scientific and technical progress in our understanding and treatment of POPs. The draft regulations will allow the UK to continue to implement the Stockholm convention requirements to prohibit, eliminate or restrict the production and use of POPs. I commend the draft regulations to the House.
Dr Neil Hudson (Epping Forest) (Con)
It is a privilege to serve under your chairmanship, Sir Roger, and a pleasure to be opposite the Minister. This is a little like “Groundhog Day”; I think we are going to be up against each other quite a lot. I wonder whether I will be like the gopher to Bill Murray’s greenkeeper in “Caddyshack”, another Bill Murray film.
I am happy to put everyone’s mind at rest: His Majesty’s loyal Opposition will not oppose the regulations. We appreciate the Government’s effort to build on our strong Conservative track record in managing persistent pollutants. This instrument adds three substances—UV-328, dechlorane plus and methoxychlor—to the assimilated persistent organic pollutants regulations. It also updates and clarifies the terms under which articles, substances or mixtures containing certain persistent organic pollutants can be manufactured, sold, used and disposed of. The updates ensure that we remain aligned with our commitments under the United Nations Stockholm convention. I am also pleased to note that the development of these changes was subjected to a public consultation in 2023.
Importantly, there is no indication that the amendments in this instrument will negatively impact businesses or disproportionately burden small businesses; we must always keep that consideration in mind. Furthermore, I am extremely pleased that the instrument aligns with the Windsor framework and will be adopted nationwide.
Although we offer no objection to the instrument, I would like to briefly highlight some broader concerns for the Minister to address. First, although the amendments build on our strong track record in managing persistent pollutants, can the Minister confirm whether the Government have identified any areas within the regulatory regime around persistent organic pollutants that they intend to change? Secondly, will the Minister provide clarity on the current trace levels of the persistent pollutants discussed today and how they compare with the limits set in this instrument? Finally, will she clarify the steps the Government are currently taking to monitor the levels of so-called forever chemicals in our environment and to ensure that they fall within a safe range?
To conclude, we will be supporting these important measures and I am grateful that the regulations have been brought to the Committee. I will be happy to continue working with the Minister to ensure that we continue to do all we can to maintain environmental safety, protecting our precious environment, animals and human public health.
Emma Hardy
I thank the hon. Member for Epping Forest (Dr Hudson) for his contribution and look forward to seeing him in many debates in future. I commend him on having been able to pronounce the names of the chemicals first time around.
I am pleased that the hon. Gentleman has raised the issue of forever chemicals, which concerns me; in time, I imagine that we will be discussing those in more detail. Obviously, we have outlined today all the details of what this particular statutory instrument relates to, but I definitely agree with his wider point on sharing concerns about POPs and forever chemicals. I hope that we can work together on that because the dangers and concerns about those chemicals are coming more to light as we move forward.
I will not detain the Committee for longer than necessary. As I have outlined, the instrument introduces changes to ensure that the UK can continue to implement its obligations under the Stockholm convention, which aims to protect the health of populations, wildlife and the environment from harmful persistent organic pollutants. I commend the draft regulations to the House.
Question put and agreed to.
Draft Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2025
(1 day, 14 hours ago)
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Martin McCluskey (Inverclyde and Renfrewshire West) (Lab)
I beg to move,
That the Committee has considered the Draft Scotland Act 1998 (Transfer of Functions to the Scottish Ministers etc.) Order 2025.
It is a pleasure to serve under your chairmanship, Mr Vickers. I am grateful for the opportunity to debate this order today. It is the result of collaborative working between the UK and Scottish Governments. The order follows agreement by the previous Government to transfer to Scottish Ministers the function of making environmental outcomes report regulations—replacing environmental impact assessments—in respect of electricity works consenting in Scotland and the Scottish part of the renewable energy zone, so that the power will be held concurrently with the Secretary of State for Energy Security and Net Zero. The transfer of functions reinstates powers lost by Scottish Ministers on repeal of the European Communities Act 1972.
The order before us will be made under section 63 of the Scotland Act 1998, which provides for any functions, so far as they are exercisable by a Minister of the Crown in or as regards Scotland, to be exercisable by the Scottish Ministers concurrently with the Minister of the Crown. This Scotland Act order is a demonstration of devolution in action.
By way of background, the UK operated a system of environmental impact assessment as a result of powers conferred by the European Communities Act 1972. The function of making environmental impact assessment regulations in respect of electricity works consenting in Scotland had been transferred to the Scottish Ministers, concurrently with the Secretary of State, in 1999. Following the designation of the Scottish part of the renewable energy zone, the extent of the Scottish Ministers electricity consent functions was extended to the Scottish part of the renewable energy zone. Subsequently, the Scottish Ministers’ associated EIA regulation-making powers were also extended to the Scottish part of the REZ.
The power to make environmental impact assessment regulations was lost on repeal of the European Communities Act 1972. The UK Government then took powers in the Levelling-up and Regeneration Act 2023 to make environmental outcomes report regulations, intended to replace environmental impact assessment regulations. This instrument transfers functions to Scottish Ministers to make regulations under part 3, chapter 1 and part 6 of the Levelling-up and Regeneration Act 2023, in relation to the assessment of the effects on the environment in connection with applications for consent, approval or variation of consent for electricity generating stations and associated overhead line infrastructure. Those functions will be exercisable concurrently with the Secretary of State. Before the Scottish Ministers seek to exercise functions by virtue of this order, they will be required to consult with the Secretary of State.
The order reflects a commitment made to the Scottish Government during the passage of the Levelling-up and Regeneration Act 2023. I am pleased that the UK Government are working to address that matter.
Andrew Bowie (West Aberdeenshire and Kincardine) (Con)
It is a pleasure to serve under your chairmanship, Mr Vickers. I am not surprised in the least to see the level of attention this order has drawn from across the House—a full house to debate an incredibly important issue.
As the Minister set out in his speech, the nub of this particular draft order is a plan to enable the exercise of concurrent powers in relation to assessing the environmental impact of and granting consent, or otherwise, for generating stations and overhead lines in Scotland, essentially devolving powers to make environmental outcomes report regulations in these areas to the Scottish Government.
We will not oppose this measure on the basis that it is our longstanding position to support the giving of powers that existed prior to our departure from the EU, and we recognise that Scottish Ministers are not currently able to amend or replace the processes in the Electricity Works (Environmental Impact Assessment) (Scotland) Regulations 2017, which underpin the regime for environmental assessments for electricity works, and which are devolved to the Scottish Government.
The Minister rightly points out that this work was begun under the previous Government, but times change and it is with regret that we cannot actively support this draft order because we have real concerns about the direction of travel of the key underlying policy areas under the new Labour Government. First, on pylons and overhead lines, we are very concerned by the Energy Secretary’s approach to building pylons across the United Kingdom. I can certainly say that in my constituency and across rural Scotland there is anxiety that pylons will spoil the countryside, restrict agricultural land use and leave homeowners unable to move or secure a mortgage for houses beside planned infrastructure build. As we set out in our manifesto, our clear preference is for undergrounding, where it is cost competitive. We worry that this Government—and the Scottish Government—have an ingrained disposition against undergrounding.
Secondly, under the plan set out in the order, Scottish Ministers would have to consult the Secretary of State before exercising the powers. But there is no proper detail about what would happen in the case of a divergence of views, or if the Scottish Government pursue an approach that is out of step with that preferred by the Secretary of State. Thirdly, following on from that point, we are yet to see a convincing plan that demonstrates how this extra layer will avoid added complexity in an area of planning and consenting that is already incredibly complicated and diverges hugely across the nations of the United Kingdom.
For those reasons—and those reasons alone—and despite the overriding principle of devolving powers from the EU to the Scottish Government, we will abstain on this order.
Martin McCluskey
The speech from the shadow Minister goes to the heart of the issue with the current Conservative party in abandoning some of their previous work purely for political expediency. The shadow Minister mentioned divergence: devolution allows for divergence, but the order clearly demonstrates that Scottish Ministers seeking to exercise functions by virtue of this order will be required to consult with the Secretary of State.
Given that the shadow Minister has responsibility for Scotland and energy, I am very disappointed that he seems to be continuing the roadblocks that we saw from the previous Government to getting Britain building, restoring and renewing our energy system, which we need to do if we are to achieve the growth we require in this country. I welcome his lack of opposition, but I am disappointed that he cannot support work that the previous Government started. The instrument demonstrates the continued commitment of the UK Government to work with the Scottish Government to deliver for Scotland.
Question put and agreed to.
Draft Aviation Safety (Amendment) Regulations 2024
(1 day, 14 hours ago)
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The Parliamentary Under-Secretary of State for Transport (Mike Kane)
I beg to move,
That the Committee has considered the draft Aviation Safety (Amendment) Regulations 2024.
It is a pleasure to serve under your chairmanship, Dr Huq. I will not burst into song, if that is okay. The draft regulations were laid before the House on 23 October.
As a member state of the International Civil Aviation Organisation, the UK has agreed to implement international standards and recommended practices—SARPs—in domestic law. SARPs are technical specifications for aviation safety contained in annexes to the convention on international civil aviation and adopted by ICAO. As a member state, we are obliged to implement any amendments made to SARPs in domestic law, unless it is impractical to comply or not relevant to our system. Where that is the case, member states must file a difference notifying the ICAO that there are discrepancies between SARPs and domestic law. The majority of differences are filed by the UK either because legislative changes are yet to be undertaken or are in progress, because they are legacy differences inherited from assimilated EU regulations that we will incorporate over time, or because they are not appropriate for the UK system.
The objective of this statutory instrument is broadly twofold. First, by updating UK law to comply with amendments to annexes 6 and 14 to the convention on international civil aviation, it will ensure that domestic aviation law meets an internationally agreed level of aviation safety. The updates pertain to enhancing fuel planning systems; to widening the scope of all-weather operations—that is, the ability of aircraft to take off and land in low-visibility conditions; and to improving flight crew training and checking. There are also updates to new and continuing airworthiness requirements relating to safety management systems.
Secondly, the statutory instrument corrects and supplements amendments to assimilated law made by the Aviation Safety (Amendment) Regulations 2023. It also reinstates two provisions that were erroneously removed by the Aviation Safety (Amendment) (EU Exit) Regulations 2020.
Before I turn to my closing comments, I draw to the Committee’s attention some minor typographical errors that have been identified in the statutory instrument since it was laid before the House. A correction slip has been issued to amend the errors and the corrections have been incorporated into the draft regulations. At the request of the Secondary Legislation Scrutiny Committee, a revised explanatory memorandum has also been laid, which now includes a link to the Civil Aviation Authority’s consultation response document on all-weather operations and fuel planning and management.
We must continue to ensure that aviation remains among the safest forms of travel, and that the safety of the travelling public is a key and No. 1 priority for everyone in this room. Some of the provisions in the draft regulations introduce new ways of using pre-existing technology, with the aim of increasing efficiency while maintaining safety standards. The provisions also correct errors to make it certain that regulations are clear. By upholding our commitments to implement international aviation safety law, we maintain both high aviation safety standards and our reputation as a world leader in aviation safety.
Before I finish, I put on the record—I am sure I speak for everybody in the room—our sadness at the crash in Vilnius yesterday and the death of the pilot of the DHL flight. Safety should, for many reasons, always be top of our priorities. I commend the draft regulations to the Committee.
Jerome Mayhew (Broadland and Fakenham) (Con)
It is always a pleasure to serve with you in the Chair, Dr Huq. I join the Minister in his words about the poor pilot of the DHL plane that crashed in Vilnius. If we needed further reminding of the importance of aviation safety, that provides it.
The draft regulations are not contentious and I reassure Government Members that I do not intend to call a Division on them. They are eminently sensible. We could go through them regulation by regulation, but in essence the Civil Aviation Authority has got out of step with the International Civil Aviation Organisation and its SARPs, the consequence of which is that, without the regulations, UK-registered aircraft cannot use more sophisticated systems and equipment. That applies both on board the aircraft, for the management of fuel and other systems, particularly to deal with low-visibility landing, and in respect of the ability to take advantage of infrastructure on the ground at aerodromes to assist in those processes.
Chapter 1 of part 2 of the draft regulations deals with instruments used for flying in poor visibility; chapter 3 deals with improvements to mandatory crew training that are associated with the relevant activities; and chapter 4 includes regulations to require improved aerodrome facilities for low-visibility conditions. There is also provision relating specifically to the use of helicopters and related infrastructure. They are all good improvements and will they help to keep the UK up to date internationally and maintain our reputation as being at the forefront of aviation safety. For those reasons, the Opposition will support the draft regulations.
There are, though, inevitably a few questions on which I would like further information from the Minister, and I will be grateful for his response. First, will the Minister have a look at the rationale behind the impact assessment of the reduced fuel load required? One of the key rationales for the regulations is to allow for more efficient flight plans and, as a consequence, for the carrying of less fuel, as a safety factor, while maintaining the same or increased levels of safety. Because there is less fuel in the aircraft, it has less weight and therefore burns less fuel.
In the cost-benefit analysis that accompanies the draft regulations, it is assessed that, across all operators of UK-registered aircraft, only £12.3 million-worth of fuel is likely to be saved. I had a quick google to find the fuel cost just for British Airways in 2023, and that single operator spent £3.83 billion on fuel. If it is estimated that the entire sector is to save just £12.3 million, it appears that the regulations, while well meaning, are not going to have any significant effect at all in what we want, which is a reduction in carbon burn, a reduction in costs and an increase in efficiency. Will the Minister confirm whether it is his understanding that the benefits are de minimis? Or is there scope for further improvement that the impact assessment does not identify?
Secondly, on the same issue, does the Minister recognise that if it is true that only £12.3 million will be saved through incremental changes, a much greater saving of both carbon and fuel costs would be achieved by a reorganisation of air traffic control routeing? I think particularly of minimising, or ideally preventing, the issue of stacking around airports and the associated congestion.
Thirdly, I will come back to congestion around airports in a moment, but before that I turn to section 14(5) of the Retained EU Law (Revocation and Reform) Act 2023. Paragraph 6.10 of the explanatory notes says that
“where changes are made to secondary assimilated EU law using section 14 of the REUL Act, the overall effect of the changes made by it under that section…should not increase the regulatory burden.”
The majority of the section 14 provisions relate to the imposition of criminal offences under the draft regulations, and the impact assessment confirms that they do not significantly increase the regulatory burden. But there is a lacuna in the impact assessment, because it identifies that there are some section 14 provisions that do not impose a criminal sanction, yet there is no assessment as to whether the rule requirement under section 14(5) is satisfied. Will the Minister confirm that there is no increased regulatory burden as a result of the non-criminal sanction provisions affected by clause 14(5)? That seems rather technical, but it would be useful to make sure that we are compliant with the existing legislation.
Finally, the Prime Minister has just returned from COP29, where he burnished his international credentials—in his view—by committing to an 81% reduction of greenhouse gases by 2035. Now, that is all very well, but in the sixth carbon budget the Climate Change Committee identified that if we are to reach that target, it can be done only by the restriction of passengers and airport capacity. Will the Minister say whether it is now Government policy to restrict any net increase in airport capacity? If it is, which airport that is currently in operation will be further restricted to allow for the increased capacity anticipated by the expansion of London City airport, which the Government have just allowed?
Mike Kane
I congratulate the hon. Member for Broadland and Fakenham on his elevation to his current position and look forward to working with him over the years to come. I had quite the turnaround in my three years of opposition, so I hope he stays longer than some of his his predecessors. It is great to welcome him. I recently spent some time with him in Northern Ireland, where we had an extraordinarily good fact-finding trip and did some relationship building with the Executive there. He should always be proud of the work his father did as Secretary of State to bring peace to our islands.
I thank Members for their consideration of the draft regulations. The hon. Member for Broadland and Fakenham asked me a number of questions, the first of which was about impact assessments. A full impact assessment was submitted with and published alongside the explanatory memorandum on the Government legislation website, so I direct him to that. It assesses the impact of amending the legislation to align with the latest ICAO SARPs concerning fuel planning and management.
The hon. Member asked about fuel. We do not think there will be significant carbon savings based on this SI, because only a few large operators will take advantage of the new fuel schemes, and only in some limited circumstances. However, I direct the hon. Member to our manifesto commitment on sustainable aviation fuel, for which we have already laid the mandate for 2%, starting on 1 January 2025, which I signed into law just the other week. That will start to grow a sustainable aviation fuel industry in the UK and begin to decarbonise our skies.
On the stacking issue that the hon. Member rightly talked about, our second key manifesto commitment was on airspace modernisation. If only we could get our planes to fly in a straight line and not in circles, we would immediately begin to decarbonise our skies. There is an easyJet plane that flies from Jersey to Luton and probably emits about 35% more carbon than it should because of the route it has to take, because we have an analogue system in a digital age. The Government are hugely committed to our two key manifesto commitments on decarbonising our skies.
On section 14 and the regulatory burden, we consider that the overall effects of the changes made under this IS will not increase the regulatory burden in this particular area. New Members should know that this is a “take back control” SI. We were a member of the European Union Aviation Safety Agency but we came out of it, and now we have to do the typos ourselves. That is the power we now possess. It would have been done elsewhere and on somebody else’s dime.
On the Prime Minister’s huge commitment on the 81%—I said at a conference the other day, “Where did he get the 1% from? Where’s that particular saving?”—the Government have embarked on an ambitious project with our missions, and we have to do it because the climate is changing. I run the lighthouses in this country, and our operatives could spend less time at sea. Storm Bert this week meant that my journey took four hours instead of two, because of flooding and damage. We have emitted trillions of tonnes of carbon. We cannot afford to begin to emit that much again. We have to change. I am sure Members from all parties agree that the international situation is getting more dire by the day. We have to become energy secure. The commitment to do that by 2030 is hugely key.
The safety of aviation and the travelling public is a priority for this Government, as it is for every Government—
Jerome Mayhew
I know the Minister was trying hard to answer all my questions, but he may have forgotten to clarify the Government’s position on airport capacity, so I will give a second opportunity.
Mike Kane
The hon. Member mentioned the Climate Change Committee’s recommendation that we should consider a demand-management system; we will formally respond to the CCC on that in the new year. My view is that Mr and Mrs Jones in my constituency should be able to take their annual holiday in Europe because they have worked hard all year.
We have never, on our side of the House, talked about demand management; I wonder whether it is a new policy of His Majesty’s official Opposition—[Interruption.] I hear the hon. Member saying from a sedentary position that it is not. It is hugely important that we decarbonise our airports, our maritime sector and our airlines, and we are doing that through our manifesto commitments on the sustainable aviation fuel mandate over the years ahead and on the airspace modernisation projects. Airports themselves are the easier bit to decarbonise, and most of them have a strategy to decarbonise themselves over the next few years. The hard part of the equation will always be the things that take off and land at our airports. There will be no demand management on this side of the aisle.
The safety of aviation and the travelling public is a priority for the Government. The Department for Transport is committed to ensuring that aviation remains safe. As part of that work, the draft regulations form part of an important legislative programme that implements international aviation safety standards in domestic law. Furthermore, the implementation of international law ensures that the UK remains a world leader in maintaining aviation safety standards and meeting our obligations. With that, I commend the draft regulations to the Committee.
Question put and agreed to.