Grand Committee
(1 day, 22 hours ago)
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Bail and Release from Custody (Scotland) Act 2023 (Consequential Modifications) Order 2024
(1 day, 22 hours ago)
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Baroness Anderson of Stoke-on-Trent
That the Grand Committee do consider the Bail and Release from Custody (Scotland) Act 2023 (Consequential Modifications) Order 2024.
Baroness Anderson of Stoke-on-Trent (Lab)
My Lords, I beg to move that the draft order, which was laid on 21 October 2024, be approved. This order is the result of collaborative working between the two Governments in Scotland and Westminster, and supports the Scottish Government’s decision to implement the Bail and Release from Custody (Scotland) Act 2023 in Scotland. The order will be made under Section 104 of the Scotland Act 1998, in consequence of the Scottish Government’s 2023 Act.
A Section 104 order is the most common type of Scotland Act order. They are used to make technical amendments to UK reserved legislation to facilitate the policy aims of an Act of the Scottish Parliament or secondary legislation made by Scottish Ministers. Scotland Act orders are a demonstration of devolution in action and I am pleased to say this is the fourth such order to be put to the House by this Government. Officials across the UK and the Scottish Government have worked closely together on this order, with consultation between the Home Office, the Scotland Office, the Office of the Advocate-General, the Scottish Parliament and the Crown Office & Procurator Fiscal Service.
I will explain the effect that this order will have and the provision it will make. I should begin by explaining that extradition proceedings take place in summary courts: these are magistrates’ courts in England, Wales and Northern Ireland, and sheriff courts in Scotland. This means that if there are changes to the legal framework for bail conditions in relation to these courts, it would also impact on extradition cases. That is what could happen in this instance; both our Governments agree that this would not be appropriate, so we are using this order to prevent that. This order does not make changes to extradition law across the UK or affect current extradition policy and legal frameworks in any way. It ensures that courts in Scotland continue to have the ability to consider the question of flight risk as a ground for refusal of bail in the context of extradition proceedings and in line with the rest of the UK.
The order will ensure that a limitation on the courts’ ability to remand persons at risk of failing to appear in court under the new test for bail in Scottish summary courts does not extend to extradition cases. This will mitigate the risks of a person wanted for extradition being granted bail under the new regime when they would not have been under the previous regime. Without this order being in force, individuals accused of serious crimes while wanted for extradition may be granted bail under the new regime, because the courts would not retain their current levels of discretion to consider the question of flight risk. This creates risks in relation to the requested person absconding and evading justice.
The Bail and Release from Custody (Scotland) Act 2023 was passed by the Scottish Parliament in June 2023. It seeks to ensure that, as much as possible, the use of remand for domestic criminal cases within the Scottish criminal justice system is a last resort, reserved for cases where public safety requires it or there is a significant risk of prejudice to the interests of justice. The Act limits the circumstances in which the court in summary proceedings in Scotland can refuse an individual’s bail application by amending Sections 23B and 23C of the Criminal Procedure (Scotland) Act 1995.
In particular, amendments to Section 23C includes a new subsection, which limits the extent to which a court may take into account any substantial risk of a person absconding or failing to appear when determining whether there is a good reason for refusing bail in summary proceedings. This would remove the ability of sheriffs to consider whether the individual in question may abscond from further proceedings unless they have already failed to appear in a Scottish domestic criminal court case. It should be noted that these restrictions would not apply to judges who are considering whether to refuse bail in summary proceedings, which are the equivalent of the Crown Courts in England, Wales and Northern Ireland.
The Extradition Act 2003, which applies across the whole of the UK, prescribes that cases of individuals arrested subject to an extradition request from an international partner are to be overseen by a specialist extradition judge. In Scotland, this is the Sheriff of Lothian and Borders. When hearing extradition cases, the sheriff has the powers available in relation to bail as if the case were summary proceedings in respect of an offence alleged to have been committed by the person. Cases proceeding by way of summary proceedings in Scotland involve less serious crimes than extradition cases currently do.
Under current Scottish bail legislation, the sheriff considering bail in an extradition case can consider the question of flight risk from the very outset of a case. This is important, as the nature of extradition means that the individual in question may pose a substantial risk of absconding or failing to appear. This order ensures that, when the provisions limiting the circumstances in which the court in summary proceedings in Scotland can refuse an individual’s bail application come into force, sheriffs retain their current levels of discretion to decide whether those subject to an extradition request are remanded in custody while they wait for their hearing.
I hope noble Lords can support this statutory instrument so that we can ensure that we have the right powers across the UK to deal with extradition requests in a fair and effective way.
Lord Cameron of Lochiel (Con)
My Lords, I thank the Minister for her opening remarks and add my thanks to the Civil Service officials in the various departments that have worked on this order.
We will not oppose the order. As has been outlined, it makes consequential changes as a result of Section 2 of the Bail and Release from Custody (Scotland) Act 2023, passed by the Scottish Parliament last year. Section 2 amends the test which the court must apply when considering whether to grant bail to a person accused of or charged with an offence in summary proceedings. As has been outlined, in essence, Section 2(3) limits the extent to which the court may refuse bail in summary proceedings when reliance is placed on a specific ground of refusal of bail: namely, that the accused, if granted bail, might abscond or fail to appear at court diets as required.
I need not detain your Lordships with the more technical aspects of that change; suffice it to say that this order excludes from the alteration made last year bail decisions in extradition proceedings. That is an important decision, and one with which we on these Benches concur. It is notable that last year in the Scottish Parliament, both Scottish Conservatives and Scottish Labour MSPs voted against the 2023 Act. Nevertheless, we are where we are. It is of paramount importance that there is alignment across the UK for granting or rejecting bail in extradition cases, given that accused persons in extradition proceedings are often considered a flight risk and that maintaining the integrity of the Extradition Act and the UK’s broader extradition system is critical, points made by my colleague Andrew Bowie MP last week in Committee.
In conclusion, I ask the Minister what discussions the UK Government have had with the Scottish Government about the interplay between UK government policy in this area and changes to Scottish criminal procedure as enacted by the Scottish Government to avoid issues such as this emerging in future. In particular, have the UK Government made any assessment of the impact on UK government policy of the Prisoners (Early Release) (Scotland) Bill, passed only this week by the Scottish Parliament?
Baroness Anderson of Stoke-on-Trent (Lab)
I thank the noble Lord—I was going to say “noble Lords”—for his contribution to the debate and for his questions. I also put on record my thanks to the Civil Service, which works tirelessly to make our Government function and to support the Opposition to make sure that we can deliver in the way that we need to.
With regard to the noble Lord’s question about making sure this never happens again, as he will know, we are trying to reset and normalise relationships and discussions with the Scottish Government and all devolved Administrations, and I hope that, as part of those ongoing and more regular discussions, issues such as this will be raised in advance. However, I welcome the fact that the Scottish Government approached the UK Government when they realised this anomaly and sought to work with the previous Administration and now the current one to fix it. That is a step in the right direction. With regard to the other issues that the noble Lord raised, I will have to write to him with an update, but I will ensure that it follows.
In closing, this instrument demonstrates the continued commitment that the UK Government have to work with the Scottish Government to deliver for Scotland, ensuring devolution in action as we celebrate 25 years of devolution. On that basis, I commend the instrument.
Voter Identification (Amendment of List of Specified Documents) Regulations 2024
(1 day, 22 hours ago)
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Lord Khan of Burnley
That the Grand Committee do consider the Voter Identification (Amendment of List of Specified Documents) Regulations 2024.
Relevant document: 5th Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Ministry of Housing, Communities and Local Government (Lord Khan of Burnley) (Lab)
My Lords, the Elections Act 2022 amended the parliamentary election rules set out in Schedule 1 to the Representation of the People Act 1983. This set out the requirement for voters to show photographic identification when voting in person in a polling station in Great Britain. The list of accepted forms of photographic ID is set out in rule 37 of Schedule 1 to the Act. It includes: passports; driving licences; various concessionary travel cards; identity cards bearing the Proof of Age Standards Scheme hologram, such as the Young Scot card or the NUS TOTUM card; blue badges; and the defence identity card.
As set out in our manifesto, the Government are committed to improving how voter ID works by addressing the inconsistencies and ensuring that legitimate electors are able to vote. We are carefully and thoroughly reviewing the voter ID rules and evaluating how they impacted citizens during the general election. Work is already under way on this evaluation, using data gathered at polling stations along with public opinion surveys and qualitative research with electors and the electoral sector.
The Electoral Commission has also conducted a thorough review of the 2024 general election. It published an interim report on voter ID in September, and a final report on the wider conduct of the polls earlier this month. We will, of course, carefully consider the findings and recommendations of the Electoral Commission as part of our own review of the voter identification policy and will respond formally to both commission reports in the new year. If, in our assessment, we find that changes are necessary or appropriate, we will bring forward further proposals on the wider voter ID policy in due course. I do not wish to speculate today on what they might be, but I will of course keep noble Lords informed on the outcomes of our work.
However, there is a clear gap in the existing provisions, which we can and should address now: the absence of His Majesty’s Armed Forces veteran card from the accepted voter ID list, which is why we made its inclusion on the list a manifesto commitment. The veteran card is a recognition of the service and dedication of our veterans to our country. This is just one of the things this Government are doing to honour their contribution. We should not allow the need for fuller consideration of the policy in the round to stop us making a necessary change that will support veterans to exercise their democratic rights.
I know that noble Lords opposite were supportive of this change when in government, and I hope that consensus remains. This instrument makes changes to the current legislation that sets out the accepted forms of voter ID and will result in the veteran card being added to the list of accepted forms of ID for the purposes of voting in Great Britain. It will mean that holders of the veteran card can use it to prove their identity when voting in person in polling stations for all elections from May 2025 onwards. The veteran card was fully launched in January this year and is now available free of charge to all veterans. This, alongside the already accepted defence identity card, will bring parity between veterans and serving armed services personnel when voting.
The regulations also make two further small changes, which are technical clarifications to support the smooth and consistent application of the law. They have been highlighted by electoral administrators operating the policy in practice. First, they provide clarification regarding the entry relating to Commonwealth passports by updating it to refer to the specific list of Commonwealth countries in the British Nationality Act 1981. This will make voter ID legislation consistent with electoral registration legislation. In particular, it will allow Zimbabwean passports to be used as identification at the polling station from May 2025.
Lord Mott (Con)
My Lords, I welcome the amendment that we are discussing today, particularly in reference to the Armed Forces veteran card. It was disappointing that it was not in place for the general election earlier this year, and I very much support what the Minister had to say today.
I also highlight and welcome the Electoral Commission’s report on the high awareness levels of voter ID when people went to the ballot box this year. There were a lot of concerns in the run-up to the election, but it is good to see that survey report high voter awareness.
The other incredibly welcome thing today, speaking as somebody who spent 32 years at the front line of politics working for a political party, is that these changes are being made well ahead of those elections in May next year. There is nothing more frustrating for a political party or political organisation than to have changes come into force at the last minute. There are implications for all political parties, not just for professionals but for the thousands of volunteers who keep our democracy vibrant in this country. Again, I thank the Government for making sure that we are making this change well in advance.
What else are the Government thinking now about participation, and how do we open up the democratic process to more people? The turnouts in the elections in July were disappointing, to say the least, and we need to make sure that everyone is completely engaged in the political process. Also, do the Government have any thoughts at this stage on further items of identification that may be added to the list?
I appreciate that my final point is a little cheeky. Having been in the Minister’s position, where I often used to say “next year” or “at some point”, could I push him a little further? He said next year; is there any date when the Government may have finished their review and he will be able to come back to us with some of those proposals? It could be quarter 1 or 2—that would be good. If we could have a little more detail around that, it would be incredibly helpful to us. As I sit down, I welcome these changes and thank him for the timely fashion in which the Government have introduced them.
Lord Hayward (Con)
My Lords, I follow my noble friend in welcoming the proposals that the Minister outlined in his opening comments. I have two or three points to raise. The first is that, when this SI was discussed in the Commons, the Minister identified that research was being undertaken by IFF Research on voter ID. Could this Minister clarify the terms identified for this work and why it is necessary, given that the Electoral Commission has in fact already undertaken its report, to which the Minister referred? It does not seem necessary to have two organisations doing the same thing.
In passing, I add my welcome to the Minister’s comments on Zimbabwe. As a former resident of that country, I am conscious that there are some 200,000 people of Zimbabwean nationality in this country; it would be helpful to that community.
I am concerned by a phraseology that the Minister used—that there might be further changes to ID that are not done as a group. If we are to make further changes to requirements for the opportunity to use certain forms of ID at polling stations, they must be introduced en bloc. We do not want a series of changes, one after another, and to have to sit in this Committee to consider them individually. It makes much more sense, whether they are because of the Electoral Commission’s work, IFF Research’s work or a combination, to bring them together as a single block. That reduces the workload on the Minister for a start, let alone for anybody else.
Although this is not quite within the field of the SI, it follows on from my noble friend Lord Mott’s question on the local elections taking place next May. Is the Minister in any position to indicate whether, in fact, those elections will be as those currently scheduled or are there likely to be any changes?
Lord Rennard (LD)
My Lords, accepting the use of the veteran card as ID for voting is a welcome improvement, but to a very poor, expensive and quite unnecessary scheme. When the previous Government introduced the requirements for photo ID at polling stations their impact assessment said that it could cost £180 million over a decade, so I hope that the new Government have other spending priorities and recognise that scrapping or changing this scheme will not endanger the fundamental security of the ballot process.
As many Members on the Government’s side said in the debate in the House of Commons, this can be only the first of many steps in helping to make sure that everyone legally entitled to vote is able to. Issues with voter ID may not affect large numbers of voters, but many elections are determined by small margins. Etched in my own memory is being the election agent for a parliamentary by-election in which just 100 votes, or 0.1% of the vote share, separated my candidate from the successful Conservative candidate—now the noble Lord, Lord McLoughlin. In the recent general election, seven seats were determined by margins between 15 and 98 votes. Many council elections are also determined by very small margins—sometimes there are even ties—so changes in the election rules really matter.
We are advised by the Electoral Commission that, on 4 July, slightly less than 0.1% of people were turned away from polling stations, never to return, because of the photo ID requirements, but that could have been the margin of victory in several seats. With the lowest turnout in a general election for 23 years, it is probably more significant that 4% of the non-voters said that their decision not to vote was related to the voter ID requirement. That is perhaps 800,000 people or 2% of the electorate.
There is no need today to repeat arguments about the motivation for introducing the photo ID rules and the complete lack of evidence ever presented to justify them. However, Jacob Rees-Mogg, the Leader of the House of Commons at the time, made it clear what the intention was. Moving forward, the Electoral Commission has suggested that we would need a much wider review of what may be acceptable if we have any form of voter ID at polling stations—more than we are considering today. It suggests, for example, that the Jobcentre Plus travel discount card and the 18-plus student Oyster photocard should be acceptable in addition to the veteran card.
Let us look back to the commission’s consistent advice of some years ago and to the last Conservative Government’s report, conducted for them by the former chair of the Conservative Party, the noble Lord, Lord Pickles. There was no suggestion from either of a photo being required on any form of ID at polling stations. In debates during the passage of the Elections Act 2022, Ministers suggested that the process for obtaining a ballot paper should be akin to that for obtaining a parcel at a post office, but they could never explain to me why the Post Office’s ID requirements —including a bank card or a credit card—could not be acceptable at a polling station.
In the review of these regulations that the Government are now undertaking, will the Minister undertake to look at the costs of the photo ID scheme, admitted by the previous Government to be more than £100 million during those debates? Ideally, he would consider scrapping it while taking steps to ensure that voters know that their vote cannot be stolen. Even Ministers in the previous Government did not seem to know that, if you go to a polling station and someone appears to have already used your name and address to get a ballot paper, you can have a replacement issued. The fact is that hardly ever happens. In the 2019 general election, it happened in just 0.00004% of cases—an average of two cases per constituency. This was mostly down to clerical error and crossing off the wrong name rather than fraud, thereby showing that the expensive scheme is quite unnecessary.
Will the Minister undertake to review in particular the costs and the value of voter authority certificates, which can be issued on request by local authorities as a form of ID? The take-up of these certificates was minimal in the general election, with many people, particularly young people, remaining unaware of them, but the costs and time involved for election officials must have been considerable.
If the Government conclude that there must still be a form of voter ID at polling stations, can the Minister confirm that the review will look at alternatives to the current scheme using the official polling card issued to every voter by electoral registration officers? When I moved an amendment to the then Elections Bill in 2022 proposing just this, I was pleased to have the support of every Labour Peer present for the vote, with none of them voting against. The noble Baroness, Lady Hayman of Ullock, who led for the Opposition at the time, said
“we believe, as the noble Lord, Lord Rennard, said in introducing his amendment, that the Government have simply got it wrong on requiring voter ID to be presented at polling stations”.—[Official Report, 27/4/22; col. 337.]
She and her colleagues then voted for my amendment, calling for the official polling card to be acceptable as ID—as did the noble Baroness, Lady Smith of Basildon, and the noble Lords, Lord Kennedy of Southwark and Lord Khan of Burnley. I am pleased to see the latter as the Minister today; I look forward to his response as to whether he and his colleagues, now in government, remain supportive of this cost-saving and effective measure if any form of ID requirement is to be maintained.
Baroness Scott of Bybrook (Con)
My Lords, I thank the Minister for bringing these regulations before the Committee. As we have heard from my noble friends Lord Mott and Lord Hayward, the timeliness of these changes is welcome. My noble friend Lord Hayward is right: it would be preferable to have any other changes come to us all at one time. I would also like to hear the Minister’s views on the possible changes to the May 2025 elections.
To go back to the SI, we on these Benches welcome the inclusion of the Armed Forces veteran card for use as voter ID. This is a sensible policy that allows our veterans to use a well-respected form of ID to exercise their democratic rights. I note that these regulations also allow for the national entitlement card issued by local authorities in Scotland to be used as voter ID. I also noted all the relevant changes to the forms required and the small changes outlined by the Minister.
These Benches’ primary concern is that the integrity of the ballot box is maintained. I therefore again seek the Minister’s assurance that this integrity will be paramount in any future changes that the Government may make.
Lord Khan of Burnley (Lab)
I thank noble Lords for their valuable contributions to this debate. I will respond to some of the points raised.
I thank first the noble Lord, Lord Mott, for his support for these regulations. I will tackle the issue he raised about additional documents being added to the list, as he asked for more clarification. On the subject of accepted documents at polling stations, I recognise that there have been calls from the public and noble Lords to include various additional forms of documents since the original voter ID rules came into effect. The noble Lord, Lord Rennard, also touched on this. We are pleased to bring forward this legislation to include the veteran card on the list of accepted documents, as this has been frequently called for since the card was fully launched.
I understand that many people would like further forms of identification to be added to the list. As I mentioned, we are continuing to review the voter ID policy. If further changes to the list of accepted documents are found to be necessary or appropriate, we will bring forward proposals in due course. I look forward to discussing them with noble Lords at that time. I make that point in particular. I have had really healthy discussions with all noble Lords who have spoken and want to ensure that I continue to have that conversation with them.
Many noble Lords touched on the theme of increasing democratic participation, as did the noble Baroness on the Benches opposite. The Government are committed to encouraging democratic engagement among all electors, including young people. We will help to encourage the engagement of young people by legislating to give 16 and 17 year-olds the right to vote in all elections.
The Government are carefully assessing the postal voting process as part of our wider review of electoral conduct and the registration processes. We have begun work on this and will work closely with stakeholders from across the sector to gather their feedback, analysis and ideas. The Electoral Commission has published its final report on the general election. We will carefully consider its findings and recommendations. Once we have completed our review, we will bring forward firm proposals for changes and improvements to our electoral system. I look forward to discussing this with noble Lords in due course. On the point about when the review will end, we expect to have a report on it in spring 2025.
The noble Lord, Lord Hayward, raised a number of important issues on Electoral Commission reports and our report in particular. I thank the Electoral Commission for its ongoing research into the running of our elections, and for its feedback and advice on potential areas of improvement. The commission published its interim report on the 2024 general election in September, focusing on the impact of the voter ID policy. Officials are already considering its recommendations. Two weeks ago, the commission published its full report on that election. This draws on the full suite of evidence and data, including surveys of candidates, returning officers and polling station staff, and feedback from charities and civil society organisations.
We will be carefully reviewing the commission’s findings and recommendations from both reports, and providing a formal response to both reports in due course. We are very cognisant of the need to ensure that the foundations of our electoral system are robust and secure, which the noble Baroness, Lady Scott, asked about, as we introduce further reforms to the way in which elections are run.
We are undertaking a strategic review of electoral registration, conduct and funding processes, looking at the biggest challenges and the pain points in the current system. We are working in partnership with the elections sector to understand how we can address these challenges in a practical and pragmatic manner. I will provide noble Lords with an update on the Government’s overall strategic approach to elections and electoral registration, including the outcomes of this review, in due course.
Baroness Scott of Bybrook (Con)
Should I assume, since the Minister is saying that we will have nothing from the review until next spring, that there will be no further changes for the May 2025 elections?
Lord Khan of Burnley (Lab)
I am sorry for any miscommunication, but what we are saying is that we want to get everything ready for the May 2025 elections. The focus is on getting the review and I am sorry if I confused noble Lords on that point. It depends what comes out of the review: depending on what it tells us, we can act on that. That is our focus.
The noble Lord. Lord Hayward, talked about the IFF research and the point that the Minister in the Commons made on this. The Elections Act 2022 included a requirement for the Secretary of State to publish an evaluation of the implementation and impact of the voter ID policy on the first local and the first two UK general elections after the Act came into force. We have therefore contracted IFF Research, an independent research organisation, to conduct a comprehensive evaluation of the July 2024 general election—we would have waited much longer for an evaluation of two general elections. It is essential that we understand how the policy has operated in practice, what has gone well and where there are any areas for improvement in the future. We expect that report summarising the work on the voter ID policy in the spring of 2025.
Lord Hayward (Con)
I thank the noble Lord for that clarification. I seek further clarification on that point: will the political parties be consulted as part of the IFF research, so that they as well as other organisations can have input?
Lord Khan of Burnley (Lab)
The noble Lord makes an interesting point. The research is independently contracted, so that is something for IFF to consider. I reassure noble Lords that I will consult across the House on any concerns they may have around ongoing work on the report or its publication.
The noble Lord, Lord Rennard, raised a number of important issues. On the voter ID policy, he reminded me and my colleagues of how we voted when in opposition. I note the concerns about the policy requiring voters to show identification when voting, which is why this Government are conducting a thorough review of the voter identification rules. This will include evaluating their impact on the 2024 general election. I, too, am waiting for that review. A number of noble Lords have raised concerns, and it is right to raise concerns about all new policies to make sure that they are working in practice, promoting democracy and helping people to turn out and vote at elections. I say to all noble Lords: let us wait for that review to take place. We will carefully consider the findings and recommendations contained in both the report we have contracted and the Electoral Commission report and will bring forward a proposal in the future.
The noble Lord talked about the voter authority certificate. There is a big issue in that approximately 210,000 people applied for a voter authority certificate between January 2023, when it was launched, and 26 June 2024, which was the deadline for the UK election, but around 26,000 certificates were used as a form of ID on 4 July. It is not clear why so few electors used the VACs they applied for, so we want to conduct a review on that point of the voter identification rules, which will include the impact in 2024 of the VACs, and any changes or improvements will wait for that review to take place.
If I have not addressed any issues, I am happy to meet noble Lords about them, as we regularly do. An important point to make before I finish—I know the noble Lord will want to come back in—is that the Government are committed to improving electoral registration and addressing lower registration rates among all groups in society. Officials are working with their counterparts in the Welsh Government to learn in particular from automatic registration pilots under way there and to see how they are taking place. We will examine different approaches and use experiences from other countries to inform our decisions. My only point here is that we are waiting for the review. The Government are working on a number of improvements in this area, and that will take a bit of time as we set out our position.
Lord Hayward (Con)
I apologise for intervening again, but I seek quick clarification on a point that I raised at the end of my comments in relation to the county council elections next year. Is the Minister in a position to indicate whether all the county council elections currently scheduled will actually take place?
Lord Khan of Burnley (Lab)
I apologise; that point was also raised by the noble Baroness opposite, and it is very important. I have just been handed a clear answer—it is exactly what I was going to say noble Lords, since I have not been informed of any plans—which is to reassure the Committee that there are no plans at the moment to cancel any elections, but if anything happens I will communicate through the usual channels of government machinery to ensure that noble Lords with a particular interest, expertise and passion in this area, over a number of years, are consulted.
We are all justifiably proud of our long history of democracy, but we should never take it for granted. The addition of the veteran card to the list of documents accepted as identification at the polling station will support this important community in engaging in the elections process and exercising their democratic rights. I hope that noble Lords will agree that these regulations provide for some important changes to our electoral rules, strengthening, widening and securing our democracy into the future. I hope they will join me in supporting the veteran community.
Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024
(1 day, 22 hours ago)
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Baroness Hayman of Ullock
That the Grand Committee do consider the Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024.
Relevant document: 6th Report from the Secondary Legislation Scrutiny Committee (special attention drawn to the instrument).
The Parliamentary Under-Secretary of State, Department for Environment, Food and Rural Affairs (Baroness Hayman of Ullock) (Lab)
My Lords, these regulations were laid in draft before the House on 24 October 2024. They introduce extended producer responsibility for packaging, which I will refer to as pEPR, in England, Wales, Northern Ireland and Scotland.
PEPR is one of the three core pillars of the Government’s ambitious packaging reforms, alongside the forthcoming deposit return scheme and the simpler recycling programme in England. These will overhaul the packaging waste system, introducing the biggest change to policy in a generation. Collectively, the packaging reforms are estimated to deliver carbon savings of more than 46 million tonnes of carbon dioxide equivalent by 2035, valued at more than £10 billion in carbon benefits.
The new system established under these regulations will modernise the producer responsibility system for packaging in the United Kingdom by shifting the costs of managing discarded household packaging from taxpayers to those businesses that supply packaging and by applying the “polluter pays” principle. These regulations also implement international best practice, exemplified by the mature systems of our European neighbours, including Belgium and Germany, where comprehensive EPR schemes have been in place for some time.
I am sure that Members will note that this SI was drawn to the special attention of the House of Lords by the SLSC. I assure Members that this was on the grounds of it being politically or legally important and it giving rise to issues of public policy that are likely to be of interest to the House.
I turn to the benefits of the scheme. The revenue raised by this new system will generate more than £1 billion annually to support local authority collection, recycling and waste disposal services. This will benefit every household in the UK and stimulate much-needed investment in our recycling infrastructure. This will make a substantial contribution to the benefits of the packaging reforms, which together are estimated to support 21,000 jobs in our nations and regions, and will help to stimulate more than £10 billion of investment in recycling capability over the next decade. Revenue from pEPR will create a much-needed injection of resources into local authorities to improve the household kerbside collection system across the UK. In England, this revenue will fund the simpler recycling reforms that will enable consistent collection of all dry packaging materials, ending the postcode lottery for recycling.
Taken together, these reforms will support this mission-driven Government’s ambition to kick-start economic growth and create the foundations required to transition to a circular economy for packaging in the UK, ensuring that resources are kept in use for longer. It is a critical first step in meeting the commitment in our manifesto to transition to a resource-resilient, productive, circular economy that delivers long-term, sustainable growth.
I will now look at the new obligations that the legislation will bring in. First, these regulations introduce an obligation on businesses that supply household packaging, referred to as “producers”, to pay the costs incurred by local authorities in managing that packaging once it has been discarded. Producers will also be obligated for the cost of providing public information about the correct disposal of packaging. Producers will start incurring fees from April 2025, and invoices will be issued from October 2025 for the 2025-26 scheme year.
Additionally, from the second year of the scheme, producer fees will be adjusted to incentivise producers to make more sustainable decisions at the production/design stage, including decisions that make it easier for products to be reused or recycled at the end of life. This will mean that a producer who uses packaging that is not environmentally sustainable, such as packaging that is not widely recycled, will incur higher fees. Conversely, those using packaging that is sustainable and readily recyclable will incur lower fees.
It is right that businesses bear the costs of managing the packaging that they place on the market, but we must also protect the small businesses that are the life and soul of our high streets and the backbone of our economy. That is why only businesses with a turnover of more than £2 million and which supply more than 50 tonnes of packaging per year will have to pay disposal fees under this new system.
To administer this system, the regulations require the appointment of a scheme administrator jointly by the four nations. This body will be responsible for the implementation of pEPR. This will include the setting of producer fees and the apportionment and payment of those fees to local authorities in order to fund their waste management services. This scheme administrator will initially be hosted within Defra.
I turn to the detail of the obligations that have been retained from the current producer responsibility system. This instrument revokes and replaces the Packaging Waste (Data Reporting) (England) Regulations 2023, along with the equivalent regulations in Wales, Northern Ireland and Scotland. The requirement for packaging producers to collect and report data on the amount and type of packaging that they supply is carried over from these regulations, as amended. This data is used to calculate producers’ recycling and fee obligations.
This instrument also revokes and replaces the Producer Responsibility Obligations (Packaging Waste) Regulations 2007 and the equivalent regulations in Northern Ireland. As was the case under these regulations, this instrument places obligations on producers to ensure that a proportion of the amount of packaging that they supply is recycled; it also requires them to provide evidence of this to the regulator. These requirements apply to all packaging, not just packaging likely to be disposed of in local authority household collections. To meet this obligation, producers must demonstrate compliance by obtaining packaging recovery notes and packaging export recovery notes from recycling facilities or those who export packaging waste for recycling.
I turn to compliance and enforcement. This instrument provides the four national regulators with enforcement powers and a duty to monitor compliance. It contains strong enforcement measures, including criminal offences and powers for regulators to impose civil sanctions in cases of non-compliance. As is currently the case, the monitoring and enforcement activity for the producer responsibility regime will be funded by the associated charges in these regulations, such as those for registration and accreditation. These charges operate on a cost-recovery basis; as such, they have been increased from the 2007 regulations to reflect the new duties placed on the regulators and the increased level of monitoring and audit activities.
In conclusion, there is no such place as “away”. It is therefore critical that we create the foundations required to transition to a circular economy for packaging, in order to ensure that resources are kept in use for longer and to secure vital carbon savings. I beg to move.
Baroness McIntosh of Pickering (Con)
My Lords, I congratulate the Minister on and thank her for bringing forward these regulations, which I wholeheartedly support; I also thank her for her clear exposition of what they contain. I have a couple of questions.
The Minister set out the responsibilities, particularly around informing households of what they are required to do. I understand that a lot of the waste that is contaminated cannot be effectively disposed of and recycled. Does the Minister know what percentage of household waste that constitutes, including whether it has gone up or down in, say, the last five or 10 years?
I am grateful to the Wildlife and Countryside Link and the Green Alliance for the joint briefing that they have produced for our use. I am also grateful to the Minister for drawing attention to the Secondary Legislation Scrutiny Committee’s report, which gave a very helpful background.
My understanding is that the regulations relate only to recycling. I wonder why the department has focused on recycling and not reuse. I have asked on a number of occasions both the Minister and her noble friend the Minister for Energy, the noble Lord, Lord Hunt, what the Government’s policy on energy from waste is. It is a good way of using household waste that has been contaminated and cannot be reused. It also prevents it going to landfill, which I understand is where most of the waste that is not recycled will go. So it not only reduces household waste and disposes of it in an energy-efficient way; it also provides an energy stream that other countries in Europe use to great effect. My late aunt and uncle in Denmark had their household heating provided by energy from waste at a reduced rate, so there was a community interest in taking it up. I have not heard anything from the Government—either this department or the department for energy—as to their views on energy from waste.
The Minister referred to kerbside collections, the cost of which is obviously quite high. I have now lost the page but one of the figures relates to the substantial cost of kerbside collections. Is it the idea that household collections will be performed by local councils, which will be reimbursed under the regulations by the funds raised? I think that the Minister alluded to this; that would seem very sensible indeed.
With those few remarks and questions, I commend the regulations, but I am interested to know how much will go to landfill; why the Government have not looked at reuse; what the percentages are for contaminated materials that cannot be recycled; and what the Government’s views are on any residual household waste going to energy from waste plants.
Baroness Bakewell of Hardington Mandeville (LD)
My Lords, I thank the Minister for her extensive introduction to this long-awaited SI. This is a complex issue; it has taken Defra and the Government since 2019 to bring it to this stage. I congratulate both of them on managing to get the devolved Administrations to sign up to more or less the same scheme, which should make things easier. I have received briefings from various producers and had face-to-face meetings for several years, and I was beginning to think that we would never get here. I am grateful to those who provided me this week with briefing material, as well as to the Secondary Legislation Scrutiny Committee for its report.
The opening section of the Explanatory Memorandum refers to implementing the “polluter pays” principle. That is to be welcomed. This is an opportunity to use the extensive powers in the Environment Act 2021 in order to implement the best environmental outcomes and to support the efficacy of reuseable packaging systems.
This SI obliges producers to provide evidence of the type of their recycling to the regulator. However, there is no information on how this is to happen, except that those manufacturers with a turnover of more than £2 million and which produce more than 50 tonnes of packaging will do this once a year. These producers will pay the fees to local authorities. Those with a smaller turnover of more than £1 million will have to report their recycling type but will not have to pay fees. There is nothing about how the information is to be collected by the manufacturer and what the format is for it to be reported.
I regret to say that this is something of a “get out of jail free” card. Defra and the Government are placing a great deal of trust in those who will pay the fee to provide the evidence of their recycling. The regulations include the principle, at Regulation 62(2)(b), that producers can offset fees for packaging that they market, as well as where they collect and recycle that packaging through self-funded initiatives.
There is a risk that producers could claim they have collected and recycled packaging when this is not the case. Research shows that 70% of soft plastic packaging waste collected by supermarkets for recycling was, in fact, incinerated. Can the Minister say why is there no standardisation of how evidence of recycling is to be provided?
Lord Blencathra (Con)
My Lords, I too thank the Government for bringing these regulations to the Committee for debate. I think all noble Lords agree that reducing the impact of pollution by waste on our environment is an important goal. These Benches wholeheartedly support that objective and we want the Government to foster innovation in the packaging sector that drives down the harms of pollution.
We all agree that recycling rates are too low in both domestic and trade scenarios. Domestic recycling is not helped by councils operating dozens of different schemes. Standardisation is essential, but these regulations impose huge bureaucratic burdens on the regulator and the industry to the very tight timescale of April 2025. As we all know, the Environment Agency is hard pushed to deliver on all its current commitments, including on flooding, and it will have massive new responsibilities under these regulations. Just look at the information which has to be sent to the EA for registration and at all the six-monthly reports that it will now have to plough through.
Here is my first question for the Minister. I should say that I, too, have a number of questions, some of which are technical; I would be happy for the Minister to write to me, as I do not expect her to be able to come up with, off the top of the head, the answers from around 500 pages of regulations. What estimate has been made of the extra staff required by the EA and what funding will be available to it? The Minister said that £1 billion will go to local authorities for their expenses, so who will pay the EA for its additional burden? If local authorities are to get an extra £1 billion, I hope that the Government will clamp down ruthlessly on this nonsense where some councils want to collect garbage—I apologise for that awful American word—and rubbish such as dirty nappies and rotten food only once a month. That is simply not acceptable; I hope that the Government will clamp down on it and stop it.
I hope that the Government will also stop councils charging for the collection of garden waste. Garden waste such as grass clippings is recyclable. There should not be a charge for that.
Then we have the cost to businesses. Many have expressed concerns with the illustrative figures suggested by Defra since most producers think that the fees will be at the top end of the illustration. For example, Defra has, I believe, suggested that the illustrative fees for glass will be between £115 and £215 per tonne. How can businesses plan on that basis, with such a wide variation, while also adding the planned increases in national insurance and business rates? This is not freeing up business to go for growth, as the Chancellor claims. I understand that, in October, 85 industry businesses signed a joint letter to the Minister, Mary Creagh, calling for the scheme to be delayed. They are not opposed to extended producer responsibility but they want to know what fees will be charged—and in good time, so that they have more time to register with the Environment Agency.
Wines and spirits member companies account for 70% of the glass used in the drinks business. They have 300 member companies and more than 60% of them are small and medium-sized enterprises. They also want to see the scheme delayed for a year, in order to sort out not just the fee structure but the definitions of “non-household waste” and “packaging designed for business use”. They say that the vast majority of waste generated in the hospitality sector is disposed of via business waste streams, which they pay for, but they will also incur EPR fees so will pay twice. Defra had promised to avoid this double counting, I believe, but it has now decided to press on with these regulations regardless, and the double counting is included. Why? Can the Minister justify this unfairness? The Wine and Spirit Trade Association says
“that all packaging sold to the hospitality sector or on-trade operators should be classed as non-household and exempted from additional EPR fees”.
Again, I would like to hear the Government’s explanation on that in due course; the Minister may write to me.
Paper and card are major recycling commodities. I understand that approximately 50% of business waste is made up of paper and card. It is important, therefore, that the regulations work—and work well—for the paper recycling industry. The Confederation of Paper Industries has a number of concerns about the
“proposed policy, particularly in the context of the … Recyclability Assessment Methodology (RAM) and the illustrative base fees”.
With regards to the RAM, it is concerned that
“the thresholds for non-paper components in the paper and card category are high and not aligned with industry standards. This methodology will lead to high levels of contaminants, potentially increasing plastic waste, reduce the quality of recyclate, and limit opportunities for innovation and sustainable packaging design. They create barriers for the recycling industry and risk undermining the recycling process”.
I simply ask: is it right about that? I do not know, but I think that we deserve an answer.
Another of the CPI’s key concerns relates to the proposed fee structure. It says that
“the structure creates a cost advantage to choosing plastic due to its lightweight nature, which risks driving material shifts from paper to less sustainable, fossil fuel-based plastics, and disproportionately affects the competitiveness of paper and board packaging”.
This concern is similar to the one raised by the noble Baroness, Lady Bakewell, when she was talking about the difference between glass and plastic.
Further, the paper industry is concerned about
“the inflationary effect of the fee structure due to higher per-unit costs; aside from these costs being passed onto consumers, it could also see the UK’s competitiveness reduced, potentially leading to disinvestment in domestic production”.
Again, I do not know whether that is right. I hope the Government can explain whether the industry is right to be concerned about that or whether it has the wrong end of the stick.
Baroness Hayman of Ullock (Lab)
My Lords, I thank noble Lords for their valuable contributions to the debate. There has been an enormous amount of questions, which I will do my best to cover but I may well end up writing in response to some of them. As the noble Lord, Lord Blencathra, said, it is a large document, although, having worked on the Levelling-up and Regeneration Bill, which I needed a wheelbarrow to get around the House, nothing ever seems large to me again. I will try to cover as many questions as I can but, if noble Lords will bear with me, I will go through Hansard and pick up anything that I miss.
The noble Baroness, Lady McIntosh of Pickering, asked a number of questions about household waste. The UK household recycling rate was 45% in 2021, with no substantial change since 2015. However, there is a lack of robust data on contamination rates, so I cannot provide any detail on that. We have used assumed contamination rates, which have been informed by data from sector experts, for the impact assessments for collection and packaging reforms.
The noble Baroness also asked about incentives or targets for reuse as well as recycling. Under pEPR, there are already incentives to support the adoption of reusable packaging. Producers are obligated only once for a piece of packaging, not for each time it is collected and reused. Additionally, where reusable items are collected for recycling by businesses, these can be offset against their overall pEPR obligations. We think that this exemption, in combination with the offsetting provisions, incentivises a move to reuse and drives a move away from single-use packaging, but we will continue to review the effectiveness of these measures to ensure that they are sufficient to meet the UK’s ambitions to increase the reuse of packaging.
The noble Baroness, Lady Bakewell, asked about enforcement and compliance. The pEPR regulations set effective and proportionate enforcement powers to achieve high levels of compliance. We have worked closely with the environmental regulators to ensure that the fees payable to them are adequate to fund the full regulatory service. One such power is the ability to issue variable monetary penalties in respect of certain offences, including the failure to register and the failure to report data. These new variable monetary penalties will enable the environmental regulators to issue financial penalties that are commensurate with the nature of the offence and the size of the business, meaning that larger businesses may face significant financial consequences for failing to comply with the regulations.
Additionally, the scheme administrator that will be created by the SI will be granted the use of civil sanctions, including variable monetary penalties, to address the non-payment of disposal fees. Where a producer fails to pay its disposal fees in the prescribed time, the scheme administrator may issue a variable monetary penalty, the amount of which will be equal to 20% of the unpaid disposal fees or up to 5% of the business’s annual turnover, whichever amount is higher. The noble Lord, Lord Blencathra, asked for more detail around the fees that would be charged.
The noble Baroness also asked about the appointment of the scheme administrator. The scheme administrator will be hosted in Defra and will report to the four Ministers of the four nations. There will be a governance structure that will include representatives from the value chain—in other words, producers and local authorities.
On the deposit return scheme, which was mentioned by a number of noble Lords, we are completely committed to launching DRS in October 2027 in England, Northern Ireland and Scotland; we laid the regulations for England and Northern Ireland on Monday. The Scottish Government are making the necessary amendments to legislation in Scotland, thereby enabling us to progress the appointment of the deposit management organisations in April next year.
Materials, the glass sector and plastics were all mentioned. I am sure noble Lords have read that in England, Northern Ireland and Scotland, glass will not be part of the DRS scheme. The Government’s position is that glass would add considerable upfront cost and create complex challenges to the delivery of DRS, particularly for the hospitality and retail sectors—as mentioned by the noble Lord, Lord Blencathra—as well as disproportionately impacting small breweries and being inconvenient for customers.
Glass drinks bottles will instead be part of pEPR. We have been engaging with industry as part of the development of our illustrative base fees, and further engagement is planned over the coming months. To ensure that heavier materials such as glass are not disadvantaged in our model, where weight is not a limiting factor, costs are apportioned according to the volume of collected material rather than the weight. PEPR provides a strong incentive to move towards reuse, to which the glass sector is well placed to respond. Given the carbon intensity of glass recycling and its durable nature, reuse is the goal. PEPR will incentivise the reuse of glass, as fees will be charged only the first time a product is placed on the market and producers will be able to offset what they recycle.
Regarding the Welsh aspect of this, the UK Government, the Department of Agriculture, Environment and Rural Affairs—DAERA—in Northern Ireland and the Scottish Government are not including glass, as I said, but the timing and the scope of the Welsh DRS scheme have not yet been confirmed. While this remains the case, there is no justification for extending the temporary pEPR disposal fee exemption on plastic and aluminium drinks containers to include glass. We will continue to work closely with the Welsh Government; once we have finally confirmed the details of their scheme, we will consider whether any amendments to the EPR regulations are needed.
I think it was the noble Baroness, Lady McIntosh, who asked whether material switching would happen because of this. Decisions on the use of packaging materials are complex and driven by a range of individual, business and market factors. At the moment, we have no robust evidence that switching would occur. As part of our illustrative base fees webinar on 3 October, we requested that the industry provide detailed evidence to support its claim; we also talked to other government departments. We have not yet received any substantial evidence. Having said that, we are planning further engagement with different sectors in December to discuss any findings and their implications. As part of this continuous engagement, we will aim to share as much detail as possible relating to pEPR fee calculations at these sector-specific round tables.
I was asked about the evidence that will be required from producers to show that packaging waste they have collected has been recycled. The regulator would not usually stipulate specific documents in relation to this requirement but would provide examples and principles acknowledging that every producer is different and may therefore have access to different evidence. A producer could obtain written confirmation from their reprocessor outlining what percentage of the materials that were collected and sent for recycling was actually recycled, but this would need to outline the reprocessing method to determine this value and the EA could expect the producer to have a documented process in place to validate this data. So it is quite complex.
The noble Baroness, Lady Bakewell, asked about single-use cups, including whether we are still committed to introducing the mandatory cup take-back scheme; I think she referred to that. We very much welcome the efforts of UK producers to lead the way on the take-back of single-use cups through voluntary initiatives, such as the National Cup Recycling Scheme. The collection and recycling of fibre-based composite cups is eligible for offsetting against pEPR fees. The Government recognise the urgent need to limit the environmental impact of single-use packaging, including fibre-based composite cups, and are considering the most effective ways to meet this challenge. I am more than happy to meet the noble Baroness to discuss this further, if she wishes.
The noble Baroness also asked about targets, PERNs and what is happening to deal with fraud in the system. The new regulations will increase the volume and frequency of data reported by packaging reprocessors and exporters to enable greater transparency right through the system. The regulations include new conditions of accreditation, and regulator fees will also increase to fund additional compliance monitoring of operators. As I mentioned earlier, there are also new civil sanctions to address non-compliance, including the ability to issue uncapped penalties.
Local authorities were mentioned by a number of noble Lords. In November, local authority chief executives were sent indicative estimates of their year 1 extended producer responsibility for packaging payment. Those estimates will cover the April 2025 to March 2026 financial year, so they will have some idea of the costs. The first payments for EPR packaging will be made by November 2025. I hope that that is helpful.
The noble Lord, Lord Blencathra, raised a number of issues around business and costs. The figures that were widely quoted in the press that it would cost industry £2 billion a year are inaccurate. Our estimate shows that the reforms will cost around £1.4 billion a year. This amount will cover local authority costs to manage household packaging waste, as well as scheme administrator costs. Individual producers will be able to reduce their bill by placing less packaging on the market—that is what the legislation is designed to do. Further, any smaller businesses are likely to be excluded due to the de minimis threshold, although it is assumed that the majority of producers will be liable. Hence, the fees will largely represent an industry-wide cost increase, with all firms facing a small increase in cost. For the average producer, cost increases due to pEPR are less than 1% of total revenue.
Baroness McIntosh of Pickering (Con)
I had one quick question about the policy on energy from waste. Obviously, if the Minister needs to write to me on it, I would be very grateful. Also, the regulations clearly state that aims should be achieved around reduction and reuse, but at the moment, the regulations address recycling only. Any thoughts on that in writing would be very helpful.
Baroness Hayman of Ullock (Lab)
The fact that there are incentives for producers to reuse is part of the purpose. It is about not just about recycling, but about changing behaviour to encourage producers to have packaging that can be reused. I hope that is the answer to that. I will write to the noble Baroness on energy from waste.
Lord Blencathra (Con)
Will the Minister write to me on the technical points made by the Confederation of Paper Industries? I think we would all like to see that response.
Baroness Hayman of Ullock (Lab)
Absolutely. As I say, we have had quite a long debate with a lot of questions, so I assure noble Lords that we will go through Hansard and write with detailed responses on any outstanding questions.
This legislation is necessary to initiate the circular economy for packaging in the UK, ensuring that materials and products are kept in use for longer. I trust that noble Lords understand and accept the need for this instrument; I very much welcome their broad support.
Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024
(1 day, 22 hours ago)
Grand CommitteeRead Full debate Read Hansard Text
Lord Cryer
That the Grand Committee do consider the Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations 2024.
Relevant document: 6th Report from the Secondary Legislation Scrutiny Committee
Lord Cryer (Lab)
My Lords, I beg to move that the Committee consider this amendment to the Human Medicines Regulations 2012 and the Medicines for Human Use (Clinical Trials) Regulations 2004. I am grateful for the opportunity today to debate this important amendment, which establishes a tailored regulatory framework to support point-of-care and modular manufacturing UK-wide, enabling decentralised methods of medicine manufacturing and moving innovative medicines closer to the patient.
The UK is leading the way as the first country to introduce a framework for these ground-breaking, decentralised methods of medicine manufacturing. We are demonstrating our commitment to supporting medical advances on the cutting edge of technology. The Government are implementing the new framework to enable a new sector of medicine manufacturing, facilitating the development of highly specialised medicines where they are most needed for patients, whether that is in hospital wards, operating theatres, community health centres or, in some cases, even in patients’ own homes.
One example of these products in development is a diabetic foot ulcer treatment using blood-derived products obtained from the patient and manufactured at the bedside. Modular manufacture can support early-stage vaccine deployment by allowing vaccines to be locally filled and finished, ensuring efficient supply to mass vaccination centres. These cutting-edge medicines are often very time-sensitive so they cannot just be picked up from a doctor, a pharmacy or a hospital in the traditional way.
I will now highlight why this change is needed. Increasingly, with advancing health technology, medicines are being developed that need to be manufactured close to patients. The approach by the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency—the MHRA—needs to adapt to support the development of new technologies. However, current arrangements are geared for centralised factory-based manufacture, with a small number of fixed manufacturing sites named on manufacturing licences and marketing authorisations.
Point-of-care and modular manufacturing products may be manufactured at multiple sites across the country. Some of these products are developed to meet the unique needs of each patient, often derived from the patient’s own cells or blood. Some products must be administered within an hour, or even minutes in some cases, of being manufactured. This creates an urgency and a specific need that traditional manufacturing cannot easily accommodate. It would be extremely challenging for these innovative products to be regulated according to current regulations, with significant regulatory and financial hurdles.
The objective of this instrument is to provide an enabling framework to allow for the safe and efficient manufacture and supply of emerging medicines still in the early stages of development, with the regulatory clarity necessary to encourage these new products and approaches. It is vital that we have a regulatory framework that is flexible for new innovations but obviously does not compromise on patient safety.
I will now set out how the MHRA will ensure that point-of-care and modular manufacture products meet the necessary standards of safety, effectiveness and quality. The new framework is centred on a hub-and-spoke model, with a single control site as the hub for each product overseeing all aspects of point-of-care and modular manufacturing, including the spokes of individual manufacturing locations and their activities. The control site will be the only named manufacturing site on the manufacturing licence, clinical trial and marketing authorisation applications. The holder of the control site, as its name signifies, will be responsible for ensuring product quality across all manufacturing sites and notifying the MHRA of reportable issues.
The diligence of the control site in overseeing manufacturing locations will be scrutinised at routine MHRA inspections, and arrangements for oversight will be scrutinised as part of the licensing process. A number of manufacturing spoke locations will also be sampled and subject to inspections, to ensure that the oversight claimed by the control site can be independently supported by inspection findings.
The new framework is a modified form of the current regulatory framework for evaluation of regulatory compliance at manufacturing sites and safety monitoring. There will be no change in the expected standards that must be met for safety, quality and efficacy of the product. There will not be an increased risk to patient safety, with the MHRA retaining regulatory oversight.
I turn in more detail to the benefits of this new framework. First, patients and carers will benefit from access to new and more personalised medicines in a timely and more convenient manner, with the potential for some patients to be treated with medicines manufactured at home. This would help to move care from hospitals to communities—I know that this has been discussed for a long time, but this gives us the opportunity to actually do that—reducing the need for patients to stay in hospitals. Secondly, it benefits healthcare professionals by providing a greater range of more effective treatment options, which can improve patients’ response to treatment. Lastly, it benefits innovators and industry, by providing clear regulatory expectations and enabling speedier product development.
The new framework will remove regulatory barriers that are not suited to novel manufacturing methods. This benefit will be seen across all sizes of companies—large as well as small and medium-sized enterprises. I am pleased to bring forward this instrument using the powers of the Medicines and Medical Devices Act, allowing us to use effective regulation to support the development of medicines at the forefront of technology, enable patient access to pioneering medicines and help to move innovative medicines closer to the patient.
Lord Kamall (Con)
My Lords, in rising, I thank the Minister. It is also my first opportunity to welcome him to his place and, just as with his colleague, the noble Baroness, Lady Merron, I look forward to working with him in the constructive way that I do with her.
We may be surprised that there is not a massive queue of speakers lining up to take this debate into tomorrow, but part of the reason is that this instrument really is not that controversial. There is consensus on this and we welcome the intent of innovation. With a lot of legislation, particularly when it comes to technology, we know that there are two debates: one is on the precautionary principle and the other is on the innovation principle. I know that we always have to balance those two issues out. It is really important that the UK continues to be a leader in innovation, particularly health innovation.
From these Benches, we support this statutory instrument, particularly, as the noble Lord says, to enable manufacturers to produce medicines with a shorter shelf life closer to the patients. What is not to like about that? I have a couple of quick questions, not in any way to trip up the Minister or score points but simply for information.
The impact assessment talks about supporting
“innovation and flexibility, for example by introducing a Control Site and framework to preclude the need for each”
point of care and modular manufacturing
“site to be named on the marketing authorisation and to be individually inspected by the MHRA”.
I just wonder whether contingencies have been thought about. We know that there are quite often unintended consequences with any legislation, even if well intentioned, but also in what contingencies have been put in place. Is there an ironclad chain of responsibility? For example, if the single control site becomes inoperable or goes down, what contingencies do the Government have to provide relief to the manufacturers? I am sure that he appreciates the intent behind that question, but that would be very helpful.
Secondly, I would be extremely grateful if the Minister could reassure us what measures there are to ensure an ironclad chain of responsibility. We know that in the modern manufacture of medicines, thinking about the recent Covid vaccine, for example, that components can come from all around the world—it is like a modern supply chain. While only one manufacturer is named on a system, are there instances involving more than one manufacturer in the process? Therefore, how do the regulator, the Government and patients know who is responsible for their medicines at which stage? I know this is done very close to the patient, but there might be questions about who is held responsible. If this is a surprise question or the Minister does not have the answer, I am perfectly happy for him to write.
I know that I might sound like a country-club bore but, as a former Minister, particularly in technology, innovation and life sciences, I have continued to maintain an interest in this area, so I can share the pride that the Government have in this system being one of the first of its kind in the world. It sends a very positive signal to the world, building on our reputation of the UK being a leader in medicine manufacturing, which was obviously highlighted when we developed the Covid vaccine very quickly. As this system is the first of its kind, we hope that the Government will commit to closely monitoring its impact and provide the results in a transparent manner, but also to highlight anything that goes wrong or is unintended so that we can learn from it.
One of the questions I generally ask about legislation is on unintended consequences. They are often there and we cannot foresee them. What guardrails or safeguards are there in place? If an unintended consequence arises, how do we remedy that? Will it simply be laying another SI to correct the error? I would be very interested in what the Minister has to say.
Overall, there is no real contention on this. We very much welcome this SI. I look forward to hearing the answers from the Minister—and I hope I have waffled on for long enough that he can get the answers from his officials, who I thank on that. In particular, I know he has an official from Lithuania, so I say “ačiū”, which I hope is the correct way of pronouncing “thank you” in Lithuanian.
Lord Cryer (Lab)
I am grateful to the noble Lord for both his contribution and his welcome. He can tell that I am still shuffling papers around.
I suppose that there are always unintended consequences to any piece of legislation; we have all been around long enough to know that. Part of the answer here is that the new hub-and-spoke method creates a degree of flexibility while not compromising health and safety standards, which means that, if there are problems in the supply chain, it would be pragmatic to put in measures that would compensate for those. If you simply have a big factory churning out tons of drugs and treatments and that factory has a problem, it is much more difficult to alleviate that problem. Also, the factories, inspection plants and other points along the hub-and-spoke model will be subject to inspections in order to ensure health and safety and quality. That is principally the MHRA but there are also—this is off the top of my head—nine other third-party agencies that are used, for want of a better phrase, by the MHRA to conduct inspections.
I want to make a few comments in closing that will partly touch on the points raised by the noble Lord. I shall summarise the key aims of the new framework and how the MHRA is already preparing to deliver these changes. Having met MHRA officials, I can say with some confidence that they have been planning for this for a long time. It is vital that the regulatory framework supports the development of new medicines while protecting patient safety, which is in essence what the noble Lord was talking about.
The safety of patients remains the paramount interest in the new framework. The regulations are not about relaxing patient safety requirements; they are about making sensible changes to reflect the circumstances in which medicines are being manufactured. The new regulatory framework is based on and links into the current regulatory processes but, obviously, the existing regulatory processes address a very different method of manufacture and distribution. The new system will ensure that point-of-care and modular manufacture products meet the necessary standards of safety, effectiveness and quality.
The new framework will also bring a wide range of benefits to patients. By opening up a new sector of medicines manufacturing, patients will benefit from access to new and more personalised medicines in a timely and convenient manner. There is potential for patients to be treated with medicines outside hospital settings, even in their own homes, thus reducing travel time; in some cases, there will be no travel time because they will be manufactured by a small device in the patient’s home. The framework supports the concept of moving care from hospitals to communities, relieving pressures on the NHS. This may also reduce the overall treatment and social care cost.
The MHRA is ensuring that the health and care sector is ready to adapt to this new framework so that the benefits can be realised. Engagement is happening now, has been happening for a while and will continue to take place with a wide range of key health partners in industry, academia and other UK regulators, including the Care Quality Commission, the Human Tissue Authority and the Health Research Authority; obviously, the GMC and the NHS are also part of the extensive stakeholder engagement network to ensure institutional readiness. The MHRA’s engagement with stakeholders through the development of the regulations, including a formal public consultation, has shown widespread support; I am talking about cross-industry support for the new framework. Industry continues to be supportive of the framework. The Government and the MHRA will continue to engage with industry and manufactures, as noble Lords might expect.
As far as international collaboration is concerned, the MHRA is working internationally to ensure maximum alignment of regulatory approaches across international regulators. That is not global, but it is as far as can be reasonably practicable. This will enable the benefits of point-of-care and modular manufacture products to reach patients across the world. This international work is particularly important as the UK is the first country to introduce a framework to enable innovative ways of manufacturing medicine, so, in effect, the UK leads the way in this field—and this is UK-wide.
In short, these changes will support wider access to life-saving, innovative medicines. I hope that noble Lords will agree with them and, on this basis, join me in supporting these important regulatory changes.
Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024
(1 day, 22 hours ago)
Grand CommitteeRead Full debate Read Hansard Text
Lord Cryer
That the Grand Committee do consider the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.
Relevant document: 6th Report from the Secondary Legislation Scrutiny Committee
Lord Cryer (Lab)
My Lords, I am grateful to be here to debate these important regulations, which herald a much-needed shift in the way we manage medical devices in Britain. This draft statutory instrument represents the first step in a series of amendments that will be introduced in the near and medium term to reform the Medical Devices Regulations 2002 to enhance the safety of medical devices, ensure availability for patients and support innovation.
To give one example—the most obvious one—the 2020 Independent Medicines and Medical Devices Safety Review, led by the noble Baroness, Lady Cumberlege, revealed the shocking experiences of patients with implanted pelvic mesh, which caused intense suffering to thousands of women. Their lives have been irrevocably changed and we must act on the lessons learned in the noble Baroness’s report. The review made it abundantly clear that, to keep patients safe, substantial reforms were needed to enable the Medicines and Healthcare products Regulatory Agency—the MHRA—to effectively regulate medical devices.
Post-market surveillance, or PMS, is vital for patient safety. PMS refers to the activities that manufacturers conduct to collect and evaluate the experience gained from their devices in real-world use. The MHRA provides regulatory oversight of this process to ensure that safety issues are identified and addressed promptly. Historically, the Medical Devices Regulations have provided only limited provisions for PMS, with guidance covering the detail. Although many manufacturers perform PMS to not just an appropriate but a very high standard, this is not universal. Bringing these requirements into legislation will ensure clarity, level the playing field for manufacturers and, crucially, improve data quality reported to the MHRA, reducing the risk of safety failures.
This statutory instrument is necessary to improve the ability of both manufacturers and the MHRA to identify issues with medical devices and take timely action. It delivers patient benefits in three key areas. First, it improves patient safety. This instrument will enable not only the MHRA but the whole health system to better protect patients by more closely monitoring the safety and performance of devices within the NHS and in local communities. This will result in more rapid identification, investigation and resolution of safety issues, allowing the NHS to focus resource effectively. The review led by the noble Baroness, Lady Cumberlege, reported that patients felt unheard and their concerns were often dismissed. These regulations will strengthen the patient voice by requiring manufacturers to undertake patient and public engagement during their PMS activities and monitoring.
Secondly, this instrument will support more rapid access for the NHS and patients to transformative—I hope—technologies. These measures provide stronger assurance that products on the market are safe and effective, which will support the implementation of new routes to market. For example, this instrument will help support the introduction of an international reliance framework as part of future medical devices regulatory reform.
Finally, this instrument will support innovation. The collection of real-world data can highlight opportunities for manufacturers to refine and improve devices. This process will result in more user-friendly and effective innovations, ultimately achieving better outcomes.
Lord Kamall (Con)
My Lords, as with the previous instrument, this side welcomes the instrument being laid. Once again, the lack of people queuing up to speak in this debate demonstrates that it is relatively uncontroversial; we now outnumber the audience, as it were.
We obviously support this instrument. The Minister was absolutely right to refer to the report by the noble Baroness, Lady Cumberlege, and to the pain and misery that the valproate scandal—and other scandals—caused so many women. On that, I know that the Minister will not be able to answer me now but I wonder whether he can write to me on the recent report by the Patient Safety Commissioner. He suggested an initial sum to be paid to the victims of that scandal, as well as looking at future remedies. Are the Government any closer to considering the Patient Safety Commissioner’s recommendations? These women have suffered enough. They have been out of pocket and have suffered physically, financially and emotionally. I would welcome an answer on that at some stage, probably in writing.
It is obviously right that we increase the scope for post-market surveillance. As a quick aside, noble Lords may know that I was a Member of the European Parliament for a few years. British companies used to lobby me on their concern that manufacturers could go to certain jurisdictions to get a CE mark then sell that product across the EU; they sometimes wondered whether the surveillance or testing of that product was sufficiently strong compared to in the UK. This gives us a huge opportunity now to be more aware of CE marks. The Health and Safety Executive for Northern Ireland says that
“the CE mark is not a quality mark, nor a guarantee that the product meets all of the requirements of relevant EU product safety law”.
It places an onus on suppliers to make sure that they comply, but not every product is tested.
That is why it is important, particularly given the scandal to which the noble Baroness, Lady Cumberlege, referred in her report, that we now take the opportunity to ensure that these products are as safe as they claim to be—not only those manufactured in the UK and GB but, particularly, those coming from abroad. I want some sort of assurance that the Minister thinks this will be an effective way to make sure that we avoid that problem.
Secondly, having left the EU a few years ago, we have to be aware that there was clearly some friction. Hopefully, we will move to a better relationship between the UK and the EU. We want to avoid unnecessary conflict, but has the Minister thought about what happens when, in the post-market surveillance, the UK regulator deems that a product from an EU country which might have a CE mark is not safe? How do we ensure that that does not cause conflict with the EU regulators for that product, and is it going be a constructive relationship?
Are the EU standards organisations fully acquainted with what we will be doing here in the UK, and open to the fact that we might find that some products are not high quality and will therefore remove them from the UK market? Will that cause conflict with the EU, given that those products have a CE marking? It will be one way of trying to reduce some of that post-Brexit friction. We might be doing it for the best reasons, but they may feel it is undermining the CE mark.
Lastly, can the Minister commit to ensuring that Northern Irish regulations remain closely aligned to Great Britain’s, so as to avoid confusion and delay? We know that the Windsor Framework produced a solution for Northern Ireland after the Brexit negotiations, but there are concerns for people in Northern Ireland about alignment with GB, understanding that there is also an alignment with the EU. Can the Minister make some commitment or give an assurance that Northern Ireland will remain as closely aligned to GB as it possibly can?
With that, these regulations are not particularly controversial. We welcome the fact that there is post-market surveillance. We wish we could have done it as strongly before, given that there have been concerns about certain medical devices. It is really important that we learn the lessons from those scandals, particularly the pelvic mesh and other scandals that have caused so much misery and suffering. We must make sure that we do not see that sort of suffering again.
Lord Cryer (Lab)
I am very grateful to the noble Lord for his comments. The Committee will not know, but he mentioned to me beforehand that he might raise products from other jurisdictions and that I might have to write to him. I should just like to say that his prediction was right: I will have to write, but I shall say a couple of things briefly.
As far as product safety from other jurisdictions is concerned—I will come to the European Union and other jurisdictions later in my closing remarks—there is a scheme for implant cards. I mentioned at the beginning that this SI will, in all probability, be the first of a number which will, at some point, cover putting implant cards into products so that their exact provenance can then be traced. If something comes from another jurisdiction that does not use that method, obviously I hope that that is in itself a way of ensuring some level of safety.
We have both mentioned pelvic mesh, for instance, which has been absolutely deadly. I will say something about that in a minute, but a few years ago there was another scandal involving really nasty breast implants which leaked. When this is fully rolled out, if a woman has a breast implant, we will have the implant card attached to the product and its provenance can be immediately seen: you can see exactly where it came from. That will hopefully ensure an increased level of safety.
As far as the victims—I think that “victims” is the right description—of pelvic mesh are concerned, I know that this has been going on for a while, but the Government are now looking at various options and, at some point in the near future, there will be an announcement on what exactly will be done.
This instrument marks an important change in how we manage medical devices in Great Britain. It will enable not only the MHRA but the whole of the health system to better protect patients. That is what this entire SI is about. The Government acknowledge that patient safety remains paramount, and these regulations must be carefully balanced to support innovation and ensure patients have access to the most effective medical devices.
Where appropriate, the new draft PMS regulations align with international requirements—which the noble Lord mentioned—helping to support the availability and favourability of the Great Britain market and reduce the additional burden on manufacturers supplying medical devices across multiple jurisdictions. The new PMS requirements will also provide a level of regulatory certainty for manufacturers, hopefully making the UK a more attractive location to launch their products.
As I mentioned in my opening comments, this draft statutory instrument represents the first legislative step towards broader medical devices regulatory reform. It will create a strong foundation for further regulatory amendments that enhance the safety of medical devices, ensuring their availability and supporting innovation. It will do this by introducing measures for medical devices after they are placed on the market.
The MHRA is also developing measures for medical devices before they are placed on the market, with the intention to lay additional draft legislation before Parliament in 2025. As I mentioned at the beginning, this will include measures for unique device identifiers—implant cards—and new rules to ensure that claims are consistent with the intended purpose of a device, although there is already existing legislation that covers that to a degree. It will also deliver changes to the classification of some medical devices.
As part of this subsequent legislation, we intend to introduce a framework for international reliance that takes into account, where it is safe to do so, decisions made by comparable regulators in Australia, Canada, the EU and the USA when determining whether a product can be sold in the UK.
Delivering these regulations first, ahead of wider regulatory reform, enables this framework by providing the MHRA with stronger assurance that devices are safe and perform as intended. It demonstrates the Government’s commitment to patient safety and responds directly to the Independent Medicines and Medical Devices Safety Review, which I and the noble Lord mentioned earlier, led by my noble friend Lady Cumberlege. The review highlighted the terrible consequences for patients when medical devices do not do what they are supposed to.
The MHRA has taken a pragmatic approach to the development of this instrument and prioritised patient safety while supporting global harmonisation across the UK medical device industry.
These regulations will be subject to a six-month implementation period. The majority of devices registered with the MHRA have EU regulatory approval and already comply, or are moving towards compliance with, EU PMS requirements. Therefore, given the similarity of these requirements with those in the EU, we do not expect manufacturers to have difficulty meeting these new GB requirements within this timeframe; however, the MHRA will continue to monitor the situation, and talk to and support industry to get it to readiness.
The MHRA is prepared for these regulations. The strengthened PMS requirements are expected to increase the volume of data and vigilance reports submitted to the MHRA. However, we anticipate that accompanying improvements to data quality will off-set this burden and support automation within the existing MHRA systems.
Before I move to my conclusion, there was one more point, about Northern Ireland. As the noble Lord mentioned, this SI, unlike the previous one, is covered by the Windsor Framework, so a separate process applies to Northern Ireland.
Having said that, I trust that we have demonstrated the need for these regulations to ensure that patients and the public continue to benefit from safe access to medical devices. As the first legislative step of the wider medical devices regulatory reform, this instrument will create a strong foundation and allow for future changes to enhance the safety of medical devices, ensuring their availability and supporting innovation. In turn, we intend to support our life sciences sector to create an environment that fosters safe innovation—I emphasise that.
Lord Kamall (Con)
I would like to have some more details, in writing, about the conversations that we will have with the EU if our post-market surveillance finds something wrong with a product that has a CE mark to make sure that that will be done co-operatively and will not be seen as causing unnecessary friction. I know that the Minister discussed international co-operation in an earlier answer. There is no need to answer now, but if he could include that in a letter to me that would be welcome.
Lord Cryer (Lab)
A process of consultation has been ongoing for quite a while. It has been done in a very constructive way on all sides, I hope, and certainly on the UK side. I will write to the noble Lord about that, as he asked.