Draft Medical Devices (Amendment) (Great Britain) Regulations 2025

Ashley Dalton Excerpts

Wednesday 23rd April 2025 General Committees

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

I beg to move,

That the Committee has considered the draft Medical Devices (Amendment) (Great Britain) Regulations 2025.

It is a pleasure to serve under your chairmanship, Sir Edward. I am grateful to be debating these short but important regulations. I will start by setting out some background. The Medical Devices Regulations 2002 provide for the safe and effective regulation of medical devices and in vitro diagnostic, or IVD, devices in Great Britain. Those regulations promote the safety and availability of such devices for British patients and ensure that the UK remains a great place to research, develop, manufacture and supply medical devices. We have a thriving life sciences sector, and this Government are determined to harness that power for growth.

The 2002 regulations originally transposed three EU directives into UK law, and they reference other pieces of EU law that form part of the regulatory framework for Great Britain. We are working to reform the regulations to improve patient safety and access to the latest innovations, but I will say more on that shortly. The statutory instrument we are discussing today prevents four of those pieces of assimilated EU law from expiring by revoking their sunset dates. Without it, they would expire on 25 and 26 May this year.

Those four pieces of assimilated EU law are: first, the decision on common specifications for IVD devices, which sets out the technical specifications—for example, around performance testing—that ensure that these devices are safe and accurate; secondly, the regulation on electronic instructions for the use of medical devices, which sets out when instructions may be provided electronically instead of on paper; thirdly, the regulation on devices manufactured using animal tissue, which sets out what must happen before these devices are placed on the market; and fourthly, the regulation on the designation and supervision of approved bodies—approved bodies are the organisations that assess whether certain medical devices meet the regulations, and this piece of EU law allows them to be properly monitored by the Medicines and Healthcare products Regulatory Agency.

These laws may seem technical, but they are also necessary, and they have been working as intended since they were introduced in the 2002 regulations. Without them, the resulting changes to well-established regulatory requirements would create industry disruption, and we would be unable to effectively regulate the medical devices industry and ensure that devices are safe and effective for patients. However, I want to be clear that this statutory instrument is a temporary measure to maintain the status quo, pending wider reforms. In time, the Government intend to fully replace these pieces of assimilated EU law as part of a broad programme of medtech regulatory reform.

Medtech has transformed the quality of care for patients since the 2002 regulations were introduced. We need only look at digital health products involving software, advanced diagnostics and AI. Diagnostic accuracy for cancers and other conditions has vastly improved, alongside tools that can identify previously undiagnosed spinal fractures. However, that is not the only reason we need updated regulations. In 2020, Baroness Cumberlege published the recommendations of her independent medicines and medical devices safety review, including those relating to device regulations. We must also keep up with the regulations of both our friends and competitors internationally.

For all those reasons, we have published plans to introduce several SIs to amend the regulatory framework for medical devices, which will improve patient safety, drive access to devices and support innovation. Some members of the Committee may recall the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, which were debated in the House in November. Those will come into force in June this year and will strengthen the legal requirements for manufacturers to monitor and report on their devices once they are being used in the real world. That will mean that safety issues can be identified, investigated and resolved faster, saving the NHS time and money. It will amplify patients’ voices by requiring manufacturers to engage with patients and the public during their post-market surveillance, where appropriate.

That SI will go hand in hand with the pre-market regulations, which we are currently developing. As the name suggests, those regulations will bring further improvements to patient safety, with additional measures that must be taken before a product goes to market. Those will include measures for unique device identifiers and implant cards, which improve the traceability of devices; new rules to ensure that claims that manufacturers make about their devices are consistent with the device’s intended purpose, so that patients are not misled; and changes to the classification of some medical devices, so that the level of regulatory burden is proportionate to the risk of the device.

That pre-market SI will also include an international reliance scheme for medical devices. That will be a huge step forward in reducing unnecessary and duplicative red tape for the medtech industry, where appropriate regulatory approval has been granted in a comparable country. That will mean that a patient waiting for a device that has already been approved by our friends in Australia, for example, does not need to wait for it to go through the same lengthy process in Great Britain. Those measures address some of the key recommendations of the Cumberlege review, while providing alternatives to the assimilated EU law in question.

That pre-market legislation is being developed with the intention of it coming into force in 2026. As well as the measures I have described, it will remove the need for two of the pieces of assimilated EU law: those relating to IVD devices and to electronic instructions for use. The reference to the EU decision on IVD devices will be replaced with a reference to the updated EU common specifications, which reflect the latest scientific and technical progress in that area. The EU regulation on electronic instructions for use will be replaced with the latest version of those rules, with some modifications for the GB market. That regulation allows manufacturers to take a more flexible and proportionate approach to providing electronic instructions for use instead of paper copies. The remaining two pieces of assimilated EU law will also be replaced in due course, as part of our ongoing efforts to improve the regulations. Indeed, the pre-market SI is not the end point of our work to ensure that the regulatory framework is up to date, safe and proportionate.

The Government will continue to work to improve the regulatory framework for devices. Technology does not stand still, and neither should our regulations. In conclusion, I hope I have demonstrated that the draft regulations are necessary for continuity and innovation, for safety and smart regulation, and for growth and the people’s priorities. I commend them to the Committee.

--- Later in debate ---

[Ashley Dalton]

I thank the shadow Minister for her input, and I will try to respond to the points she raised. The MHRA has published the road map for this process, and I can let her have a copy of it after the debate; it sets out the timeframe for the various steps that need to be taken. Specifically on further SIs, there will be a further SI dealing with two of these issues by the end of the year, and two further SIs in 2026 and 2027.

On Northern Ireland, we are obviously aware that there are concerns and issues that have to be dealt with differently. Once the provisions have been updated, the GB framework will still refer to EU law, but certain domestic requirements may differ from those in other jurisdictions. However, we recognise the benefit of international harmonisation of medical device regulations. Of course, we will ensure that any future legislation meets our obligations under the Windsor framework.

On US tariffs, the Committee will appreciate that there is an ongoing discussion, and decisions have not yet been made by the US. I would not want to pre-empt or second-guess any decisions made by colleagues. Obviously, those tariffs will be taken into account once we have a final view of what they might look like.

[Dr Johnson]

My understanding is that the US Government are reviewing whether the tariffs will affect medical pharmaceutical products. However, some manufactures of medical devices, as per this SI, are concerned that the tariffs that have already been announced affect medical devices. Can the Minister please give more clarity on that?

[Ashley Dalton]

I am not able to give further clarity on that today, but I am more than happy to write to the shadow Minister when we have some more clarity.

I hope I have set out why these regulations, while only a small part of the wider reform programme, are nevertheless important to ensuring a smoothly functioning regulatory environment. They will give manufacturers certainty and ensure that patients can continue to access safe and effective devices. They are just a small part of the reforms that are under way, and I am grateful to members of the Committee for playing their part in bringing them into force.

Question put and agreed to.

Childhood Obesity

Ashley Dalton Excerpts

Monday 7th April 2025 Written Statements

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

Today, I am updating the House on the implementation of the TV and online advertising restrictions for less healthy food or drink that are due to come into force UK-wide on 1 October 2025. I wish to re-confirm the Government’s view on how the restrictions will apply to brand advertising, and give an update on how we are working with Ofcom and the Advertising Standards Authority, as the regulators, to ensure an effective and proportionate implementation of the restrictions.

This Government have set a bold ambition to raise the healthiest generation of children ever and take action to address the childhood obesity crisis. As part of this ambition, this Government made a manifesto commitment to implement advertising restrictions for less healthy food and drink on TV and online. These are designed to reduce children’s exposure to less healthy products, based on evidence that they contribute to childhood obesity, as well as incentivise businesses to reformulate their products and help create a healthier food environment for our children. Alongside this and in support of the Government’s growth mission, we want to deliver proportionate regulation that balances the health benefits with the impact on businesses.

To achieve these objectives, the Communications Act 2003—as amended by the Health and Care Act 2022 —sets out that the restrictions will apply to adverts for ‘identifiable’ less healthy food and drink products. ‘Identifiable’ means if persons in the UK could reasonably be expected to be able to identify an advert as being for a less healthy product.

While it is for a court to interpret the legislation, the Government’s view remains that pure brand advertising is not in scope of this policy. This is because the legislation only restricts adverts that could reasonably be considered to be for identifiable less healthy products, and not adverts that could be reasonably understood to be advertising brands. This has been the consistent position of this Government and was clearly stated to Parliament during the passage of the Health and Care Bill. We therefore expect that businesses will still have opportunities to promote their brands, provided that their adverts do not identify a less healthy product. For example, brands could promote their non-product attributes, such as corporate social responsibility commitments or customer experience, or advertise the healthier products within their portfolios. We do not expect the perception of a corporate brand, or its association with less healthy products, to automatically bring an advert into scope of the restrictions. The Government do not intend to prevent brands from advertising, but instead intend to give businesses an incentive to innovate and create healthier products.

We understand that businesses need clarity in order to plan and secure future advertising campaigns. We also recognise the considerable investment they have already made in preparing for the restrictions coming into force. The Government have been clear that, while a robust regulatory framework is needed, we expect regulators to act in a way that supports economic growth, and helps industry to make future investment decisions and innovate with confidence.

The Government and the regulators share the same aims: to offer clarity and support to businesses as these restrictions are introduced. While it is of course for the regulators to act independently, we anticipate that they will want to act quickly and firmly on any obvious breaches of the law where a less healthy product is clearly identified in an advert. However, in other instances and where the circumstances make it appropriate, in the Government’s view, the law provides considerable discretion in how the available enforcement tools can be used positively to support a business to move to compliance over a period of time.

The ASA will finalise its implementation guidance following consultation. We know that the ASA is already engaging with industry and will continue to do so following publication of the final guidance later in the spring.

By implementing the advertising restrictions and taking preventative action now, the Government are beginning to fix the foundations of good health, and are protecting the next generation, so that it can become the healthiest ever.

[HCWS579]

Drug and Alcohol Treatment and Recovery Grant

Ashley Dalton Excerpts

Monday 31st March 2025 Written Statements

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

On 31 March, the Government published the targeted drug and alcohol treatment and recovery grant funding for local authorities in England for 2025-26.

Drug and alcohol addiction costs the country billions of pounds in additional health and criminal justice expenditure.

Dedicated investment in high-quality treatment and recovery services will reduce crime and save lives. This will benefit people who are experiencing drug and alcohol addiction, their families, and communities, many of whom are vulnerable with complex needs. Through access to individual placement and support employment support, we can help people to sustain their recovery and local employers to recruit from an untapped pool of talent.

This funding is an important component of our plan for change in health, through which we will build an NHS fit for the future, tackle the underlying drivers of ill health and health inequalities, and deliver three fundamental shifts: from hospital to community, from analogue to digital and from sickness to prevention.

It contributes to the safer streets mission by reducing crime and re-offending and funding services that continue to provide support for people who are sleeping rough who have a substance misuse problem. It also supports the opportunity mission by increasing support and early intervention for children and young people’s substance issues as well as reducing the adverse childhood experience of parental substance misuse.

Allocations will see £310 million go directly to councils to build on their vital work of improving outcomes for people who need treatment and recovery support.

Full details of the grant allocations to local authorities for 2025-26 can be found on www.gov.uk. This information has been communicated to local authorities.

[HCWS568]

Down Syndrome Act 2022: Local Authority Guidance

Ashley Dalton Excerpts

Friday 28th March 2025 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

I thank the hon. Member for Windsor (Jack Rankin) for securing this debate on such an important topic. I am also grateful to him for his work with the all-party parliamentary group on Down syndrome.

People with Down syndrome should have the same opportunities to participate fully in society like everyone else, but we know this does not always happen. There is a pressing need to raise awareness of the needs of people with Down syndrome and how they can be met. While every person with Down syndrome is a unique individual, they often face common health risks.

For example, we know that almost half of children with Down syndrome are born with a heart condition. We also know that people with Down syndrome may need additional support with their speech, hearing or vision. And as the average life expectancy of a person with Down syndrome continues to rise—an increase I am very pleased to see—this means that more people require additional support in later life. This may be additional support with new, age-related health needs, as well as increased demand for social care services.

This Government are committed to ensuring that all people with Down syndrome receive the care and support they need to lead the lives they want in their communities, and we are taking action to achieve that by implementing the Down Syndrome Act. The Act lays the foundations to ensure that every person with Down syndrome can live a full and fulfilling life through accessing the health and care services they need, receiving the right education, securing appropriate living arrangements that work for them, and being supported into employment. We recognise that there is still much to do to achieve that, but I can assure the hon. Gentleman and the House that the Government are working on the implementation of the Act as a priority.

The Down Syndrome Act requires the Secretary of State for Health and Social Care to give guidance to relevant authorities in health, social care—including local authorities—education and housing services on what they should be doing to meet the needs of people with Down syndrome. Earlier this month, Minister Kinnock wrote to sector partners and the all-party parliamentary group on Down syndrome with an update on the development of the guidance, including the Government’s plan to put the guidance out for consultation by the summer. That followed a roundtable on 26 November, which Minister Kinnock—

[Madam Deputy Speaker (Caroline Nokes)]

Order.

[Ashley Dalton]

Oh, sorry!

[Madam Deputy Speaker]

Twice!

[Ashley Dalton]

I’m so sorry!

That followed a roundtable on 26 November, which the Minister for Care, my hon. Friend the Member for Aberafan Maesteg (Stephen Kinnock) convened to discuss with partners how we can improve life outcomes for people with Down syndrome and the opportunities that the guidance presents in support of that.

We appreciate that many of the issues that have been raised are borne out of a desire to ensure the guidance is as effective as possible and published as soon as possible. We know just how important the guidance is. I can assure the hon. Gentleman that a huge amount of work has been, and continues to be, carried out to develop the guidance. And we, like others, want to make sure the guidance is fit for purpose and impactful.

It has been vital that people with lived experience, and the organisations that work to support them, are involved at every stage of the work to develop the guidance. A range of sector engagement has taken place. That includes a national call for evidence, partner working groups, and a review of evidence to gain a better understanding of the specific needs of people with Down syndrome. Throughout the process, there have been differences in opinion on the scope of the guidance and how it should be drafted. Officials have worked hard to build consensus on these issues, but, as I am sure Members can appreciate, it is not always possible to resolve differing opinions quickly, especially on a topic as important as this. While that means the development of the guidance has taken longer than we all had hoped, it is only right that the issues are given the due consideration they deserve. The Minister responsible set out his position on the issues at hand in his recent letter to sector partners.

Our position remains that the guidance will be Down syndrome-specific, in accordance with the Government’s statutory duty under the Act. It is our intention to include references to where the guidance could have wider benefit. That is in line with the commitment made during the Bill’s passage through Parliament. This is not about moving the focus away from Down syndrome. The guidance is about meeting the needs of people with Down syndrome. It is about taking the opportunity, through the guidance, to help as many people as possible. Officials will continue to work with partners to ensure the guidance has the maximum benefit for all communities involved.

I can confirm to the hon. Gentleman that I have today secured a commitment that the Minister will work with sector partners to ensure that people with Down syndrome have direct access to, and are supported in taking part in, the consultation.

I would like to thank the individuals and organisations across the country who have worked tirelessly to help us develop the guidance. Their contributions have been invaluable throughout, and we appreciate their continued patience while we work to finalise the guidance for consultation. We would also welcome their support to ensure that the communities they represent are aware of the consultation and can share their views.

We are grateful to members of the all-party parliamentary group on Down syndrome for their engagement and can assure them that their comments on the guidance have been considered throughout the development process. The Minister in charge wrote to the APPG on 18 March. Officials will share a second draft of the guidance with sector partners for feedback in the coming weeks. I can assure the hon. Gentleman that I will pass on his comments to the Minister responsible, as requested.

On specific training, under existing legislation, Care Quality Commission-registered providers must ensure that staff receive the appropriate professional development necessary for them to carry out their duties, and must receive specific training on learning disability and autism appropriate to their role. We expect that providers should be considering whether specific training on Down syndrome is required for their staff. Officials will work with stakeholders to signpost that effectively in the guidance we are developing under the Down Syndrome Act.

I thank again the hon. Gentleman for securing this important debate.

Question put and agreed to.

Prevention of Drug Deaths

Ashley Dalton Excerpts

Thursday 27th March 2025 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

It is a pleasure to serve under your chairmanship, Dr Murrison. I congratulate the hon. Member for Strangford (Jim Shannon) on securing this debate. He raised a number of important points, and I agree that the rise in drug-related deaths across the UK is deeply concerning. I thank all hon. Members for their contributions.

We in the Department of Health and Social Care are aware of this issue, even on a personal level. Just last month, a homeless man known as Paddy died of a drug overdose just around the corner from 39 Victoria Street. Paddy was known to many civil servants and was noted for the gentle way he looked after his dog. His death, less than a 10-minute walk from this place, should remind us of the stark realities that many people face every day. It serves as a painful reminder that, while we in this Chamber discuss policies and politics, real lives are at stake on our doorstep.

Paddy’s story is not an isolated one; it is a tragic reflection of the systemic issues that continue to affect vulnerable people in our society. His death has brought home most vividly to us that behind every statistic is a human being who deserves dignity, care and support. My family, too, has been affected by drug-related death. As I rise to speak, my cousin Stephen, who we lost in this way, tragically young, is at the forefront of my mind.

There is no doubt that illicit drugs have a devastating impact on communities across the four nations of the United Kingdom. Drug misuse deaths have doubled since 2012. More than 3,300 people died in England alone in 2023, the highest rate since records began in 1993. Drug and alcohol deaths are the leading cause of premature mortality in those aged under 50.

These deaths are preventable, and this Government are committed, through our health mission, to ensuring that people live longer, healthier lives. We recognise that, as my hon. Friend the Member for York Central (Rachael Maskell), the hon. Member for Mid Dunbartonshire (Susan Murray) and others, including the Liberal Democrat spokesperson, the hon. Member for Chichester (Jess Brown-Fuller), pointed out, this is a public health issue. That is why I, as the Minister responsible for public health, am standing at the Dispatch Box today.

We are determined to make our communities safer, more secure and free from the violence caused by the illicit drugs market through our safer streets mission. Although the Opposition seem to have sent the shadow Health Minister, the hon. Member for Sleaford and North Hykeham (Dr Johnson), here to speak almost entirely about criminal justice issues, I will focus most of my comments on the public health areas and write to her afterwards with some of the details that she raised.

We know that many people struggling with drug addiction are already at the sharpest end of inequality and often have multiple and complex needs. The links between homelessness, deprivation and people who have spent time in prison with addiction are profound. Tackling the blight of illicit drugs is an issue that cuts across our four nations. It is crucial, now more than, ever that we work together and share learning to tackle the harms that drugs cause. My Department continues to work very closely with our colleagues in the devolved Governments, and I am grateful for that ongoing collaboration.

I also want to take this opportunity to put on record and add my voice to the condolences to the family and friends of Christina McKelvie. I look forward to meeting ministerial counterparts in the devolved Governments later this year to discuss how we can continue to work together to reduce drug-related deaths.

On the harms caused by drugs, the hon. Members for Mid Dunbartonshire and for Brighton Pavilion (Siân Berry) raised some issues about the Home Office and public health. This is a mission-led Government and, although I stand here as a Public Health Minister, we will continue to work closely with the Home Office and the Department for Education—indeed, across Government —on the drugs agenda. I met my right hon. Friend the Minister for Policing, Fire and Crime Prevention just last week to discuss this complex issue. Although we have no plans to decriminalise drug possession—prohibiting drug possession helps to reduce the availability of drugs and sends a clear signal that using drugs is not normal—we support programmes that divert drug users away from the criminal justice system and into treatment.

If we are really to shift the dial on drug-related deaths, we must ensure that anyone with a drug problem, wherever they are, can access the help and support they need. That means providing evidence-based, high-quality treatment. Those dedicated drug treatment services reduce harm and provide a path to recovery. My Department is continuing to invest in improvements to local treatment services, which faced significant cutbacks during a decade of disinvestment, and the local authority funding allocations for 2025-26 will be announced imminently. I recognise the contributions made by my hon. Friend the Member for Stafford (Leigh Ingham) about the importance of community-based treatment.

[Grahame Morris]

I am very pleased with the Minister’s response. I appreciate that she has an awful lot on her plate, with cancer services and piloting a Bill through the House of Commons yesterday, but, given that we are looking at evaluating the evidence on what works best, will she agree to meet me and a small group of representatives from the treatment providers, so that they can explain in person what they think is the most effective way to tackle this issue?

[Ashley Dalton]

I would be delighted to do so. As my hon. Friend knows, consultation and engagement are at my very core. I would be happy to meet him and others.

My Department has invested an additional £267 million in 2024-25 to improve the capacity and quality of drug and alcohol treatment services, alongside £105 million made available by the DHSC, the Department for Work and Pensions and the Ministry of Housing, Communities and Local Government to improve treatment pathways and recovery specifically for people who are sleeping rough, and housing and employment support. The Government have also awarded £12 million to projects across the UK that are researching innovative technology to support people with addictions and to prevent drug-related deaths.

As of January this year, there were 43,500 more people in drug and alcohol treatment, including more than 4,500 children and young people, and 12,500 more people in long-term recovery. There are around 340,000 people in structured treatment in England, which I am pleased to say is the highest number on record.

The hon. Members for Mid Dunbartonshire and for Brighton Pavilion, and my hon. Friends the Members for Easington (Grahame Morris), for Glasgow West (Patricia Ferguson) and for Kilmarnock and Loudoun (Lillian Jones), all referred to drug consumption rooms. This Government recognise the exercised prosecutorial independence of the Lord Advocate of Scotland in respect of the pilot drug consumption room known as The Thistle in Scotland. Along with the Home Office, we will consider any evidence that emerges from the evaluation of that pilot and report on it in due course.

My hon. Friend the Member for Warrington North (Charlotte Nichols) talked about safe inhalation pipes; I will write to her with further information on them in due course, because there is an academic research study under way to test their effectiveness. The Office for Health Improvement and Disparities is part of the advisory group and is waiting to see the findings.

Mental health issues and trauma often lie at the heart of substance use issues. People with co-occurring mental health and substance use problems find it hard to engage with support, and services too often fail to meet their needs. That must change. We are committed to ensuring cohesion between mental health services and substance use services, which will mean that people no longer fall through the gaps of treatment. Jointly with NHS England, my Department has developed a mental health action plan to tackle this issue, which I hope will be published soon.

My hon. Friend the Member for Falkirk (Euan Stainbank) talked about naloxone, which other hon. Members also mentioned. I know that tackling drug-related deaths is a key priority for all four nations, and I am proud that together we have legislated to widen access to naloxone, the lifesaving medicine that reverses the effects of an opiate overdose. We know that over half of the people struggling with opiate addiction are not engaged in treatment at all, which means that significant numbers of an incredibly vulnerable population are at increased risk of overdosing and dying. The UK-wide naloxone legislation that came into force in December 2024 enables more services and professionals to supply the medication, which in turn makes it easier to access for people at risk and their loved ones. We are also working to set up a registration service in England that will further expand access to naloxone.

We are highly alert to the growing threat posed by synthetic opioids, which were raised by many hon. Members, including my hon. Friends the Members for Wolverhampton West (Warinder Juss) and for Easington. Synthetic opioids such as nitazenes and fentanyl are often more potent and deadly, but naloxone is an effective medicine for synthetic opioid overdose. The Government are undertaking a range of actions to prevent the rise of these dangerous drugs and working with colleagues across the devolved Governments, including on increased surveillance and enforcement.

I thank my hon. Friend the Member for Stoke-on-Trent North (David Williams) for raising the important issue of children affected by parental drug use. Our mission-based approach will ensure that every child has the best start in life and that we create the healthiest generation of children ever, which includes supporting the children of parents with drug problems and those suffering adverse childhood experiences.

My Department is leading work to improve the health system’s ability to respond to and support the needs of those people who have drug addiction and multiple and complex physical health needs. Intervening earlier and treating co-occurring physical health conditions will reduce drug-related deaths and improve recovery outcomes.

The Office for Health Improvement and Disparities has an action plan in place to reduce drug and alcohol-related deaths, and I was pleased to announce that on 1 May this year my Department will host a national event on preventing drug and alcohol-related deaths, where we will work with the sector to agree priorities.

I again thank the hon. Member for Strangford for securing this debate. I can assure everyone that this Government are committed to reducing the harms illicit drugs pose to both individuals and across wider society. These deaths are avoidable, and I am confident that the Government’s mission-led approach will put us in a stronger position to tackle this complex issue. Harm reduction and strong public health approaches are at the heart of this Government’s work to prevent drug related deaths.

Hughes Report: First Anniversary

Ashley Dalton Excerpts

Thursday 27th March 2025 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

It is a pleasure to serve under your chairship, Ms Furniss. I congratulate my hon. Friend the Member for Washington and Gateshead South (Mrs Hodgson) on securing this important debate, and I thank all hon. Members for their powerful words on this emotive topic.

I know that my hon. Friend met with the Minister for Patient Safety, Baroness Merron, last November to discuss the transparency of industry payments to healthcare practitioners, one of the nine recommendations that the independent medicines and medical devices safety review put to the then Government in 2018. This is something that the Government take extremely seriously. We must ensure that lessons are learned, and that is why we are putting patient safety at the heart of improving our health and social care system. I will continue to build a system that listens, hears and acts with speed, compassion and proportionality.

I want to repeat the apology that the previous Government made, which was echoed by my predecessor, the hon. Member for Gorton and Denton (Andrew Gwynne), and by Baroness Merron. I say to all of those mentioned today—to Samantha and her family; to my hon. Friend the Member for Washington and Gateshead South’s mam; to the constituents of my hon. Friends the Members for Leeds South West and Morley (Mark Sewards) and Stoke-on-Trent North (David Williams), my hon. and learned Friend the Member for Folkestone and Hythe (Tony Vaughan) and the hon. Member for Chichester (Jess Brown-Fuller); to Karen from Harrow East; to Bev from Bury North; to Colleen, Andy and Byron from North West Norfolk; to Paula and Gillian from Bexleyheath and Crayford; to Paula Goss; and to all those affected in the Gallery and across the country—we are sorry. We are sorry for the time the system took to listen to you and to your families. Everyone who has suffered complications from sodium valproate and pelvic mesh implants has our deepest sympathies and our assurance that we have listened and will continue to listen to those affected.

I am grateful to the Patient Safety Commissioner, Dr Henrietta Hughes, and her team for the Hughes report, which was published just over a year ago. It built on the important work started by Baroness Cumberlege in 2020. We will continue to work closely with Dr Hughes on how best to support affected patients and prevent future harm, on both this issue and a number of others.

The independent medicines and medical devices safety review was among the first of its kind, shining a searing spotlight on the harmful side effects of certain medicines and medical devices, including sodium valproate and pelvic mesh. The Cumberlege review revealed grave systemic issues in our health system that needed to be addressed with urgency. They covered areas ranging from the healthcare system’s lack of engagement with patients to the lack of safety monitoring for devices once they are on the market. That is why we are working to improve how the system listens and responds to concerns raised by patients; to strengthen the evidence base on which decisions are made; and to improve the safety of medicines and medical devices.

Recommendation 8b of the IMMDS review stated that there should be mandatory reporting for industry payments made to the health sector, akin to the Physician Payments Sunshine Act in the US. The previous Government accepted that in principle and held a six-week consultation. I recognise the importance of transparency and trust in the health system, and the Department is considering options regarding payment reporting, with an aim to publish a response later this year.

I absolutely understand why colleagues are pushing for clarity on our response to the Hughes report. I am acutely aware that this is a difficult and sensitive topic, and I appreciate frustrations about timescales, but this should not be rushed. The Government will need to consider carefully all the options and the associated costs before responding to the report’s recommendations. I assure Members that we will continue to progress this work across Government, ensuring that lessons are learned, and I will commit to writing to Baroness Merron on the timescales, as requested by so many Members today.

[Sir Julian Lewis]

I think it is true to say that the author of the Hughes report anticipated that the Government would want to take their time over these matters, but that is why Dr Hughes—and Baroness Cumberlege, I believe, as well—recommended an interim payment. If at least that interim payment could be made, people might be more patient about the bells and whistles that have to be added to the response later.

[Ashley Dalton]

I do appreciate the frustrations. Since we came into government last July, patient safety has been, and I can confirm that it remains, a top priority for this Government. Although it has been a year since the publication of the Hughes report, this is a complex issue involving several Departments, and it is important that we get the response right. As I have said, I will commit to writing to Baroness Merron on timescales, as requested, to get further clarification on that, and we are committed to learning from other instances in which patient safety has been impacted. The infected blood inquiry was mentioned by the right hon. Member for Salisbury (John Glen).

[John Glen]

I am extremely grateful to the hon. Lady for giving way. I was not trying to suggest earlier that her tenure in office would be short-lived; I wish her every success in her endeavours. I think the spirit of today has been about cross-party consensus, not seeking to make political points about this matter, but what I will say to the Minister is that she can go back to her officials and say that there are two very recent precedents for interim payments, under the infected blood compensation scheme, of quite significant numbers. They were maximised, so that there would be no loss to the public purse—that is to say, they were entitlements that everyone would have been able to receive. That mechanism is there, so this can happen sooner. I recognise what the Minister is saying and I wish her well in her endeavours, but she should be able to do something with that information.

[Ashley Dalton]

I assure the right hon. Member that we are working at pace on this. It is a complicated matter, and we are taking note of previous similar situations. I assure him and the rest of the House that we will be updating the Patient Safety Commissioner at the earliest opportunity. I appreciate that it is frustrating that I cannot give an exact date or timescale in this debate, but we are working to make sure that we get this right.

[Bob Blackman]

The Minister is absolutely right in saying that patient safety must be at the forefront. However, we know that 40% of babies whose mothers took these drugs have developmental problems and one in nine have severe handicaps following birth, yet the drugs are still being prescribed to pregnant women. Will the Minister have a look at what can be done to make sure that pregnant women who suffer from epilepsy can at least be advised about the position and then decide whether they want to take the risk or not?

[Ashley Dalton]

I am encouraged that the number of women still being prescribed sodium valproate has reduced significantly following the Medicines and Healthcare products Regulatory Agency’s introduction of the valproate pregnancy prevention programme. In April 2018, 27,441 women aged under 55 were prescribed valproate in England, but in March 2024, that number had come down to just under 16,000—a reduction of 42%. Nobody should stop taking valproate without advice from their healthcare professional. Beyond lowering prescription rates, I am also grateful to see Dr Rebecca Bromley, who is in the Public Gallery, heading up the foetal exposure to medicines service pilot study. The study is running for 18 months and was commissioned by NHS England. It is a multidisciplinary clinical service that is providing expert assessment, diagnosis and advice to individuals harmed following exposure to sodium valproate. We recognise those concerns.

Patients know what support they need. The Government are determined to make sure that patients feel, and are, truly heard, and to give them more choice and control over their healthcare. The Patient Safety Commissioner rightly sought views from those affected about the issues they are facing with service provision and what support they feel would be most valuable. Hearing from patients is at the heart of our consideration of the Hughes report, which is why Baroness Merron held a roundtable in December with groups representing patients impacted by sodium valproate and pelvic mesh. I know she remains extremely grateful to all attendees for sharing their stories and those of the patients that they represent.

I am aware of the time, and there are many issues that I have been unable to cover in the short time available. However, I commit to writing to all hon. Members who have raised specific concerns. Words cannot express how sorry we are to the women who have suffered from severe and life-changing complications from both sodium valproate and pelvic mesh. We are actively considering this issue, and I wish there were more I could say at this time. I have heard the calls for swiftness, clarity and boldness in the commissioner’s recommendations, and I shall bring that forward at the earliest opportunity. I am sure that this is not the last time this important topic will be discussed, and I know that colleagues will continue to hold our feet to the fire until this gets done.

Tobacco and Vapes Bill

Ashley Dalton Excerpts

Report stage
Wednesday 26th March 2025 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

I beg to move, That the clause be read a Second time.

[Madam Deputy Speaker (Judith Cummins)]

With this it will be convenient to discuss the following:

New clause 1—Review of contaminated e-liquid—

“(1) Within six months of the passage of this Act, the Secretary of State must conduct a review into the prevalence of contaminated e-liquid in England, Wales, Scotland and Northern Ireland.

(2) The review required under subsection (1), must include, but is not limited to an assessment of—

(a) the awareness of the issue of contaminated e-liquid,

(b) the extent of e-liquids found spiked with illegal substances,

(c) the measures in place to tackle the importation of contaminated e-liquid,

(d) measures used by other jurisdictions to combat the importation and prevalence of contaminated e-liquid, and

(e) options for further regulating e-liquid to limit the dangers of contamination.

(3) In conducting the review required under subsection (1), the Secretary of State may consult with whoever they see fit.

(4) The Secretary of State must report to Parliament following the conclusion of the review.

(5) The Secretary of State has the power to make regulations under this section including the power to make—

(a) offences relating to the contamination of e-liquid, including the distribution, importation, supply and merchandising or tampering of such products,

(b) offences relating to the online sale of e-liquid containing illegal substances,

(c) provisions to improve the ability to identify, test and intercept contaminated e-liquid, and

(d) provisions recommended in the review implemented by subsection (1).

(6) For the purposes of this section,

‘contaminated e-liquid’ means e-liquid which has been mixed with or includes an illegal substance.”

This new clause would require the Secretary of State to conduct a review and publish a report on the impact of contaminated e-liquid and ways to reduce its prevalence. It would give the Secretary of State the powers to make regulations in relation to curbing the harm caused by contaminated e-liquid.

New clause 2—Ban on the supply of plastic cigarette filters—

“(1) The Secretary of State must make regulations under section 140 of the Environmental Protection Act 1990 having the effect of prohibiting the supply of relevant cigarette filters or cigarettes containing relevant cigarette filters, whether by way of sale or not, in the course of a business.

(2) The notice required under section 140(6)(b) of the Environmental Protection Act 1990 in relation to the regulations mentioned in subsection (1) must be published no later than the end of the period of 12 months beginning with the day on which this Act is passed.

(3) In this section,

‘relevant cigarette filter’ means a filter which contains plastic and which is intended for use in a cigarette, whether as part of a ready made cigarette or to be used with hand rolling tobacco or other substances to be smoked in a cigarette.”

This new clause requires the Secretary of State to make regulations, within two years, which would prohibit the supply of cigarette filters which contain plastic or cigarettes containing cigarette filters which contain plastic. The regulations would be made under section 140 of the Environmental Protection Act 1990.

New clause 3—Amendment of the European Union (Withdrawal) Act 2018—

“(1) The European Union (Withdrawal) Act 2018 is amended as follows.

(2) In section 7A of the European Union (Withdrawal) Act 2018, after subsection (4), insert—

‘(4A) This section does not apply in relation to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC.’”

This new clause asserts the primacy of the regulations made in this Bill which affect Northern Ireland in relation to the EU tobacco directive 2014/40/EU.

New clause 4—Ban on manufacture and sales of high-strength nicotine pouches—

“(1) It is an offence to manufacture a high-strength nicotine pouch.

(2) It is an offence to—

(a) sell or expose for sale a high-strength nicotine pouch, or

(b) offer or expose a high-strength nicotine pouch for sale.

(3) It is an offence for a person to have a high-strength nicotine pouch in their possession with intent to supply it to another in the course of business.

(4) In this section ‘high-strength nicotine pouch’ means a nicotine pouch that—

(a) is intended for oral use,

(b) is not intended to be inhaled,

(c) does not contain tobacco, and

(d) contains more than 20 milligrams of nicotine per pouch.

(5) It is a defence for a person charged with an offence under subsection (2) to prove that they took all reasonable steps to avoid the commission of the offence.

(6) A person who commits an offence under this section is liable—

(a) on summary conviction, to imprisonment for a term not exceeding the general limit in a magistrates’ court, or a fine, or both;

(b) on conviction on indictment, to imprisonment for a term not exceeding 2 years, or a fine, or both.”

This new clause provides for a ban on the manufacture and sale of high-strength nicotine pouches.

New clause 5—Report on sale of vaping products to facilitate child sexual exploitation—

“(1) Within six months of the passing of this Act, the Secretary of State must produce a report on—

(a) the potential prevalence of retailers with a personal or premises licence selling vaping products which facilitate child sexual exploitation; and

(b) whether licensing authorities have adequate powers to investigate retailers which may be connected to the sale of vaping products to facilitate child sexual exploitation.

(2) A copy of this report must be laid before both Houses of Parliament.

(3) In this section—

‘vaping’ has the same meaning as in Part 1 (see section 48),

‘licensing authority’ has the same meaning as in Part 1 (see section 16),

‘personal licence’ has the same meaning as in Part 1 (see section 16),

‘premises licence’ has the same meaning as in Part 1 (see section 16).”

New clause 6—Requirement for retailers of vapes in England to include age-verification technology—

“(1) The Secretary of State may make regulations making it an offence for a tobacco retailer who sells vapes on premises in England to sell vapes that do not contain approved age-gating technology.

(2) The Secretary of State may by regulations specify the requirements with which any age-gating technology must comply, which must include (but need not be limited to)—

(a) the information, including biometric information, that a user must provide to the age-gating technology in order to be able to use the vape;

(b) the steps that the age-gating technology must require the user to take in order to verify their identity and that they are aged 18 or over before first activating the vape for use;

(c) the steps which the age-gating technology must require the user to take in order to verify their identity following activation of the vape, and the frequency with, and circumstances in, which the age-gating technology must require these steps to be taken;

(d) the requirements with which the age-gating technology must comply in order to ensure the security of the information, including personal data, provided to it by users;

(e) the technical specifications which the age-gating technology must meet in order to ensure that it is compatible with vapes made by different manufacturers.

(3) The Secretary of State may by regulations under this section make further provision about requirements with which tobacco retailers must comply.

(4) In this section, ‘age-gating technology’ means technology designed to prevent the use of vaping products by persons aged under 18.

(5) Before making regulations under this section the Secretary of State must consult any persons the Secretary of State considers it appropriate to consult.

(6) Regulations under this section are subject to the affirmative resolution procedure.”

This new clause would introduce a requirement for retailers of vapes in England to include age-verification technology.

New clause 7—Requirement for retailers of vapes in Wales to include age-verification technology—

“(1) The Welsh Ministers may make regulations making it an offence for a tobacco retailer who sells vapes on premises in Wales to sell vapes that do not contain approved age-gating technology.

(2) The Welsh Ministers may by regulations specify the requirements, with which any age-gating technology must comply, which must include (but need not be limited to)—

(a) the information, including biometric information, that a user must provide to the age-gating technology in order to be able to use the vape;

(b) the steps that the age-gating technology must require the user to take in order to verify their identity and that they are aged 18 or over before first activating the vape for use;

(c) the steps which the age-gating technology must require the user to take in order to verify their identity following activation of the vape, and the frequency with, and circumstances in, which the age-gating technology must require these steps to be taken;

(d) the requirements with which the age-gating technology must comply in order to ensure the security of the information, including personal data, provided to it by users;

(e) the technical specifications which the age-gating technology must meet in order to ensure that it is compatible with vapes made by different manufacturers.

(3) The Welsh Ministers may by regulations under subsection (2) make further provision about requirements with which tobacco retailers must comply.

(4) In this section, “age-gating technology” means technology designed to prevent the use of vaping products by persons aged under 18.

(5) Before making regulations under this section the Welsh Ministers must consult any persons that the Welsh Ministers consider it appropriate to consult.

(6) Regulations under this section are subject to the affirmative resolution procedure.”

This new clause would introduce a requirement for retailers of vapes in Wales to include age-verification technology.

New clause 8—Prohibition of advertising of vaping, nicotine and heated tobacco products—

“(1) The Secretary of State must within six months of this Act being passed make provisions by regulations for the prohibition of advertising of—

(a) a vaping product; or

(b) a nicotine product; or

(c) a heated tobacco product.

(2) Before making regulations under this section the Secretary of State must consult any persons the Secretary of State considers it appropriate to consult.

(3) Regulations under this section may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament.”

This new clause commits the government to consult on proposals for prohibiting the advertising of vaping, nicotine or heated tobacco products.

New clause 9—Marketing of products to existing smokers—

“(1) The Secretary of State, or a person authorised by the Secretary of State, may make provision about the nature and inclusion of health warnings or disclaimers relating to a relevant product to ensure that the product is marketed exclusively to existing smokers as an alternative to smoking.

(2) In this section, ‘relevant product’ refers to—

(a) a vape, or

(b) a nicotine product.

(3) Compliance with this section is considered a defence to a charge in relation to an offence under Part 6.”

This new clause will allow the Secretary of State to place an additional disclaimer or warning on products.

New clause 10—Displays of products or prices in England—

“(1) The Secretary of State may by regulations impose limitations or requirements on retailers in relation to the display, in the course of business, of—

(a) relevant products in a place in England where the products are offered for sale,

(b) empty retail packaging of relevant products in a place in England where the products are offered for sale,

(c) prices of relevant products in a place in England where the products are offered for sale, or

(d) advertisements for relevant products.

(2) In subsection (1), reference to a product includes anything that represents the product.

(3) Regulations under this section—

(a) must make provision—

(i) for ensuring that an adult is able to be informed that a premises sells a related product,

(ii) for ensuring that a consenting adult is able to view the related products and information relating to them,

(iii) relating to the appropriateness of a display to ensure that it does not appeal to children, and

(iv) relating to the location of a display in a place in England where the products are offered for sale;

(b) may create offences for a failure to comply with the regulations;

(c) must provide for any offence to be punishable–

(i) on summary conviction, to imprisonment for a term not exceeding the general limit in a magistrates’ court, or a fine, or both;

(ii) on conviction or indictment, to imprisonment for a term not exceeding 2 years, or a fine, or both;

(d) are subject to public consultation;

(e) are subject to the affirmative resolution procedure.

(4) Compliance with regulations made under subsection (3) is considered a defence to a charge in relation to an offence under Part 6.

(5) For the purposes of this section—

‘consenting adult’ means an adult who has entered any licensed premises that sells nicotine, vapes, and tobacco products;

‘relevant products’ mean—

(a) tobacco products,

(b) vaping products, or

(c) nicotine products.”

This new clause will allow for the Secretary of State to restrict how vapes and nicotine products are advertised in store windows and in store, while ensuring that adult smokers are still able to determine that a premises sells a product.

New clause 12—Review of provisions—

“(1) The Secretary of State must, in consultation with the appropriate ministers in Wales, Scotland and Northern Ireland—

(a) carry out a review of the provisions for relevant products in—

(i) sections 1 to 6 (sale of tobacco etc);

(ii) sections 50 to 55 (Part 2 Sale and Distribution: Scotland: sale of tobacco etc);

(iii) sections 68 to 72 (Part 2 Sale and Distribution Northern Ireland sale of tobacco etc);

(iv) sections 90 to 93 (Product requirements etc);

(v) section 94 (Non-compliant images);

(vi) sections 101 and 102 (Matters dealt with by 2016 Regulations);

(vii) Part 6 (Advertising and Sponsorship);

(b) prepare and publish a report setting out the conclusions of the review;

(c) lay the report before Parliament.

(2) The review in subsection (1) must—

(a) set out the objectives intended to be achieved by the provisions as set out under subsection (1)(a),

(b) assess the extent to which those objectives have been achieved, and

(c) make a recommendation on whether the provisions as set out under subsection (1)(a) remain appropriate and necessary.

(3) The first review under this section must be published and laid before Parliament before the end of the period of five years beginning with the day on which the Tobacco and Vapes Act 2025 is passed.

(4) If the review recommends under subsection (2)(c) that one or more of the provisions set out under subsection (1)(a) are no longer appropriate or necessary, the Secretary of State must make arrangements for the motion mentioned in subsection (5) to be tabled in both Houses of Parliament within a period of 28 sitting days beginning immediately after the review is laid before Parliament under subsection (3).

(5) The form of the motion in subsection (4) is—

‘That the provisions of sections 1 to 6, 50 to 55, 68 to 72, 90 to 94, 101 and 102 and Part 6 (Advertising and Sponsorship) of the Tobacco and Vapes Act 2025 should expire.’

(6) If both Houses of Parliament approve the motion in the form set out in subsection (5) (or in such form as may be subsequently amended by the House to specify one or more of the provisions of sections 1 to 6, 50 to 55, 68 to 72, 90 to 94, 101 and 102 and Part 6), moved by the Secretary of State in accordance with subsection (4), the provisions specified in the motion shall expire at the end of the period of 21 days beginning with the day on which the second House approves the motion.

(7) Subsequent reports must be published at intervals not exceeding five years.

(8) In this subsection, ‘Relevant products’ refers to—

(a) tobacco products;

(b) nicotine products.”

This new clause requires a review of the necessity of provisions relating to the sale restrictions for tobacco products and nicotine products. Published every 5 years, the review could recommend that certain provisions are no longer required, and Parliament would have an opportunity to expire them.

New clause 13—Reports on roadmap to a smoke-free United Kingdom—

“(1) The Secretary of State must, on or before the relevant day and at least once every five years after that day, prepare and lay before Parliament a report setting out—

(a) how the Secretary of State expects the smoke-free target will be achieved;

(b) the steps proposed to achieve that target (which may include the setting of interim targets);

(c) an analysis of statistical data relating to the achievement of the smoke-free target.

(2) The reports must set out targets and proposed steps relating to geographical areas or categories of people in respect of which there are higher than average rates of smoking.

(3) The Secretary of State must consult the appropriate national authorities when preparing the reports.

(4) In this section—

(a) ‘appropriate national authority’ means—

(i) Welsh Ministers,

(ii) Scottish Ministers, and

(iii) Executive Ministers in Northern Ireland.

(b) ‘relevant day’ means the last day before 25 December 2026 which is a sitting day for both Houses of Parliament;

(c) ‘the smoke-free target’ means the end of the smoking of tobacco products in the United Kingdom.”

This new clause requires the Secretary of State to prepare and lay before Parliament five-yearly reports containing a roadmap to a smoke-free country including targets and specific interventions for populations with high prevalence rates.

New clause 14—Prohibition on supply of cigarette filters—

“(1) The Secretary of State must make regulations having the effect of prohibiting the supply of cigarette filters or cigarettes containing cigarette filters, whether by way of sale or not, in the course of a business.

(2) Subsections (6), (8), (9), (10), (10A), (10B), (10C) and (10D) of section 140 of the Environmental Protection Act 1990 apply to regulations under this section as they apply to regulations under those sections.

(3) The notice required under section 140(6)(b) of the Environmental Protection Act 1990 as applied by subsection (2) in relation to the regulations mentioned in subsection (1) must be published no later than the end of the period of 12 months beginning with the day on which this Act is passed.

(4) In this section, ‘cigarette filter’ means a filter which is intended for use in a cigarette, whether as part of a ready-made cigarette or to be used with hand rolling tobacco or other substances to be smoked in a cigarette.

(5) Regulations under this section are subject to the affirmative resolution procedure.”

This new clause requires the Secretary of State to make regulations which would prohibit the supply of cigarette filters or cigarettes containing cigarette filters.

New clause 15—Advertising exemptions for specialist vaping retailers—

“(1) A person does not commit an offence under any of the sections 114 to 118 in relation to an advertisement whose purpose or effect is to promote a vaping product if the advertisement—

(a) Is in a specialist vaping shop

(b) Is not visible from outside the specialist vaping shop

(c) Complies with the requirements (if any) specified by the appropriate national authority in regulations as to the inclusion of health warnings and information.

(2) Regulations under subsection (1) are subject to the negative resolution procedure.

(3) In this section—

‘appropriate national authority’ —

(a) In relation to specialist vaping shops in England, means the Secretary of State,

(b) In relation to specialist vaping shops in Wales, means Welsh Ministers,

(c) In relation to specialist vaping shops in Scotland, means Scottish Ministers, and

(d) In relation to specialist vaping shops in Northern Ireland, means the Department of Health for Northern Ireland;

‘shop’ includes a self-contained part of a shop (and, in relation to a self-contained part of a shop,

‘premises’ means that self-contained part);

‘specialist vaping shop’ means a shop selling vaping products by retail (whether or not it sells other things) more than 90% of whose sales on the premises in quest derive from the sale of vaping products and vaping accessories.

(4) For the purposes of determining whether a shop is a specialist vaping shop the sales are to be measured by the sale price—

(a) During the most recent period of 12 months for which accounts are available, or

(b) During the period for which the shop has been established, if it has not been established long enough for 12 months’ accounts to be available.”

This new clause would enable specialist vaping retailers to operate and provide free advice and consultations to smokers who are trying to find the right product for them to quit.

New clause 16—Online sale of tobacco products—

“(1) It is an offence to supply a tobacco product through an internet service, whether by way of sale or not.

(2) It is a defence for a person charged with an offence under this section to prove that they took all reasonable steps to avoid the commission of the offence.

(3) A person who commits an offence under this section is liable on summary conviction to a fine not exceeding level 4 on the standard scale.

(4) For the purposes of this section—

‘internet service’ means a service that is made available by means of the internet, even if it’s made available using a combination of the internet and an electronic communications service as defined in Section 32(2) of the Communications Act 2003.”

This new clause creates an offence of selling tobacco products online.

New clause 17—Tobacco products statutory scheme: consultation—

“(1) The Secretary of State must consult and report on the desirability of making a scheme with one or more of the following purposes—

(a) regulating, for the purposes of improving public health, the prices which may be charged by any producer or importer of tobacco products for the supply of any tobacco products,

(b) limiting the profits which may accrue to any producer or importer in connection with the manufacture or supply of tobacco products,

(c) providing for any producer or importer of tobacco products to pay to the Secretary of State an amount calculated by reference to sales or estimated sales of those products (whether on the basis of net prices, average selling prices or otherwise) to be used for the purposes of reducing smoking prevalence and improving public health.

(2) In this section—

‘importer’ in relation to tobacco products, and “tobacco products” have the meaning as in Part 5 (see section 112),

‘producer’ in relation to tobacco products, is to be construed in accordance with the meaning of ‘production’ in Part 5 (see section 112).”

This new clause would require the Secretary of State for Health and Social Care to consult on proposals for regulating the prices and profits of, and to raise funds from, tobacco manufacturers and importers.

New clause 18—Consultation on licensing regulations—

“(1) Within two months of the passing of this Act, the Secretary of State must publish draft regulations for the licensing of retail sale of tobacco products etc in England.

(2) Following the publication of the draft regulation as set out in subsection (1) the Secretary of State must publish a call for evidence seeking views on the efficacy and suitability of the draft regulations and invite the House of Commons Business and Trade Committee to scrutinise the draft regulations.

(3) After six months of the passing of this Act, the Secretary of State must lay before both Houses of Parliament a report setting out the Government’s formal response to evidence submitted in response to the call for evidence required by subsection (2) and any recommendations of the House of Commons Business and Trade Committee.

(4) The Secretary of State may not make an order under section 168(4) bringing sections 16 to 18 and Schedules 1 and 2 into force until the report specified in subsection (3) has been laid before both Houses of Parliament.”

This new clause would require the Secretary of State to publish draft regulations for the licensing of retail sale of tobacco products etc in England and ensure they receive parliamentary scrutiny.

New clause 19—Reports on illegal sale of tobacco and vaping products—

“(1) The Secretary of State must—

(a) prepare an annual report on the scale of the illegal sale and availability of tobacco and vaping products in the United Kingdom; and

(b) lay a copy of each report before both Houses of Parliament.

(2) Each report must provide details in the United Kingdom of—

(a) the estimated amount and value of illegal, counterfeit and contraband cigarettes and other tobacco products available for sale;

(b) the estimated amount and value of illegal or non-compliant vapes available for sale;

(c) the action taken to tackle the illicit trade of tobacco, tobacco products, vaping devices and vaping products; and

(d) an assessment of the impact of the illicit trade of tobacco, vapes and nicotine products on public health and safety.

(3) The first report must be laid within the period of 12 months of the passing of this Act.

(4) Each subsequent report must be laid annually beginning with the day on which the previous report was laid.”

This new clause would require that the Government produce annual reports on the rate of sale and availability of illegal tobacco and vaping products and their impact on public health and safety.

New clause 20—Age verification requirement for online sales of vaping devices and products—

“(1) A person commits an offence if the person—

(a) continues to operate an online vaping product business, and

(b) fails to operate an age verification policy in respect of online sales of vaping products and devices.

(2) An ‘age verification policy’ is a policy that steps are to be taken to establish and ensure the age of a person attempting to buy a vaping product (the ‘customer’) is not under 18 years of age.

(3) The appropriate national authority may by regulations amend the age specified in subsection (2).

(4) The appropriate national authority may publish guidance on matters relating to age verification policies, including, in particular, guidance about—

(a) steps that should be taken to establish a customer’s age,

(b) documents that may be used as evidence of a customer’s age,

(c) training that should be undertaken by the person selling vaping products,

(d) the form and content of notices that should be displayed on websites; and

(e) the form and content of records that should be maintained in relation to an age verification policy.

(5) A person guilty of an offence under subsection (1) is liable on summary conviction to a fine not exceeding level 2 on the standard scale.

(6) Regulations under subsection (3) are subject to the affirmative resolution procedure.

(7) In this section—

‘the appropriate national authority’ means—

(a) in relation to England, the Secretary of State, and

(b) in relation to Wales, the Welsh Ministers,

‘online vaping product business’ means a business involving the sale of vaping products by retail online.”

This new clause introduces a requirement on online vaping product businesses to operate an age verification policy covering steps to be taken to establish the age of persons attempting to buy vaping products online. It reflects provisions in place in Scotland.

New clause 21—Prohibition on manufacture and retail of high-capacity count vaping devices—

“(1) The Secretary of State must produce regulations relating to the design, manufacture and sale of vaping devices and products that ensure—

(a) Vaping devices must not be designed or manufactured in a way that allows refill containers, modular attachments, or third-party modifications that increase e-liquid capacity beyond the limit of 2ml per tank or pod, which includes, but is not limited to detachable extensions, multi-pod configurations, and external refill reservoirs.

(b) Any vaping device must contain a fixed, non-modifiable single-use tank or pod with a maximum capacity of 2ml.

(c) Refill e-liquid containers must be limited to a maximum of 10ml per bottle and must not be sold in forms that enable direct integration with a vaping device as an extended tank or automated refill mechanism.

(d) No manufacturer or retailer shall promote, sell, or advertise modification kits, refill systems, or accessory attachments designed to contravene the Tobacco and Related Products Regulations 2016 restrictions on vaping device capacity.

(2) A person commits an offence if they—

(a) Manufacture, import, distribute, or sell a vaping device or accessory that does not comply with the regulatory requirements set out in subsection (1).

(b) Advertise, market, or sell components that facilitate increasing a device’s effective e-liquid capacity beyond the legal limit.

(3) A person who is guilty of an offence under subsection (2)(a) shall be liable on summary conviction to a fine of £20,000 per violation or a ban on further sales within the UK market.

(4) A person who is guilty of an offence under subsection (2)(b) shall be liable on summary conviction to a fine of £10,000 per violation and may be subject to further regulatory action, including product recall or withdrawal from sale.”

This new clause would seek the introduction of regulations and new offences to prohibit the manufacture, design and retail sale of high-capacity count vaping devices.

Amendment 103, page 1, line 4, leave out clause 1.

This amendment removes the generational ban on selling tobacco products to people born on or after 1 January 2009.

Amendment 4, in clause 1, page 1, line 5, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment makes it an offence to sell tobacco products, herbal smoking products and cigarette papers to a person under the age of 21, rather than to people born on or after 1 January 2009.

Amendment 38, page 1, line 7, leave out “a tobacco product” and insert

“cigarettes or hand rolling tobacco within the meaning of the Standardised Packaging of Tobacco Products Regulations 2015 (S.I. 2015/829)”.

Government amendment 47.

Amendment 5, in clause 1, page 1, line 13, leave out

“shown that document was before 1 January 2009”

and insert

“showed that the purchaser was not under the age of 21”.

This amendment is linked to Amendment 4.

Government amendments 48 and 49.

Amendment 104, page 2, line 10, leave out clause 2.

This amendment is linked to Amendment 103.

Amendment 6, in clause 2, page 2, line 11, leave out “18” and insert “21”.

This amendment makes it an offence to purchase tobacco products, herbal smoking products and cigarette papers on behalf of a person under the age of 25, rather than a person born on or after 1 January 2009.

Amendment 7, page 2, line 12, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 6.

Amendment 39, page 2, line 13, leave out “a tobacco product” and insert

“cigarettes or hand rolling tobacco within the meaning of the Standardised Packaging of Tobacco Products Regulations 2015 (S.I. 2015/829)”.

This amendment is linked to Amendment 38.

Amendment 8, page 2, line 18, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 6.

Government amendment 50.

Amendment 105, page 3, line 3, leave out clause 5.

This amendment is linked to Amendment 103.

Amendment 9, in clause 5, page 3, line 8, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 4.

Amendment 106, page 3, line 25, leave out clause 6.

This amendment is linked to Amendment 103.

Amendment 10, in clause 6, page 3, line 30, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 4.

Amendment 11, page 3, line 32, leave out

“a anwyd ar neu ar ôl 1 Ionawr 2009”

and insert “dan 21 oed”.

This amendment is linked to Amendment 4.

Government amendments 51 to 59.

Amendment 1, in clause 38, page 20, line 19, leave out from “be” to the end of line and insert

“be allocated by the relevant Local Authority to public health projects.”

This amendment would direct funds from Fixed Penalty Notice fines to public health initiatives as determined by Local Authorities.

Amendment 2, page 20, line 20, leave out from “before” to the second “the” and insert

“such sums are allocated by the relevant Local Authorities”.

This amendment is consequential upon Amendment 1.

Government amendments 60 to 63.

Amendment 107, page 25, line 26, leave out clause 50.

This amendment is linked to Amendment 103.

Amendment 40, in clause 50, page 25, line 30, after “subsection (1)” insert—

“(i) for ‘a tobacco product’ substitute ‘cigarettes or hand rolling tobacco within the meaning of the Standardised Packaging of Tobacco Products Regulations 2015 (S.I. 2015/829)’, and”.

This amendment exempts tobacco products other than cigarettes and hand rolling tobacco from the offence of selling tobacco products to a person born on or after 1 January 2009.

Amendment 12, page 25, line 30, leave out “‘born on or after 1 January 2009’” and insert “‘under the age of 21’”.

This amendment is linked to Amendment 4.

Amendment 13, page 25, line 33, leave out

“‘born on or after 1 January 2009 (“the customer) to have been born before that date”’”

and insert

“‘under the age of 21 (“the customer”) to be aged 21 or over’”.

This amendment is linked to Amendment 4.

Amendment 14, page 25, line 37, leave out

“born on or after 1 January 2009”

and insert “under 21”.

This amendment is linked to Amendment 4.

Amendment 15, page 26, line 1, leave out subsection (3).

This amendment is linked to Amendment 4.

Amendment 41, page 26, line 6, leave out “a tobacco product” and insert

“cigarettes or hand rolling tobacco within the meaning of the Standardised Packaging of Tobacco Products Regulations 2015 (S.I. 2015/829)”.

This amendment is linked to Amendment 40.

Amendment 42, page 26, line 28, after “subsection (1)” insert—

“(i) for “a tobacco product” substitute “cigarettes or hand rolling tobacco within the meaning of the Standardised Packaging of Tobacco Products Regulations 2015 (S.I. 2015/829)”, and”.

This amendment is linked to Amendment 40.

Amendment 16, page 26, line 28, leave out

“‘born on or after 1 January 2009’”

and insert

“‘under the age of 21’”.

This amendment is linked to Amendment 4.

Amendment 17, page 26, line 30, leave out

“‘born on or after 1 January 2009’”

and insert “‘under 21’”.

This amendment is linked to Amendment 4.

Amendment 18, page 26, line 33, leave out

“‘born on or after 1 January 2009’”

and insert

“‘under the age of 21’”.

This amendment is linked to Amendment 4.

Government amendment 64.

Amendment 108, page 35, line 24, leave out clause 68.

This amendment is linked to Amendment 103.

Amendment 19, page 35, line 28, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 4.

Amendment 43, page 35, line 30, leave out “a tobacco product” and insert

“cigarettes or hand rolling tobacco within the meaning of the Standardised Packaging of Tobacco Products Regulations 2015 (S.I. 2015/829)”.

This amendment exempts tobacco products other than cigarettes and hand rolling tobacco from the offence of selling tobacco products to a person born on or after 1 January 2009.

Government amendment 65.

Amendment 20, page 35, line 37, leave out

“shown on that document was before 1 January 2009”

and insert

“showed that the purchaser was not under the age of 21”.

This amendment is linked to Amendment 4.

Government amendments 66 and 67.

Amendment 109, page 36, line 13, leave out clause 69.

This amendment is linked to Amendment 103.

Amendment 21, page 36, line 16, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 6.

Amendment 22, page 36, line 18, leave out “18” and insert “21”.

This amendment is linked to Amendment 6.

Amendment 23, page 36, line 19, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 6.

Amendment 44, page 36, line 21, leave out “a tobacco product” and insert

“cigarettes or hand rolling tobacco within the meaning of the Standardised Packaging of Tobacco Products Regulations 2015 (S.I. 2015/829)”.

This amendment is linked to Amendment 43.

Amendment 24, page 36, line 26, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 6.

Government amendment 68.

Amendment 110, page 37, line 19, leave out clause 72.

This amendment is linked to Amendment 103.

Amendment 25, in clause 72, page 37, line 27, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 4.

Government amendments 69 to 79.

Amendment 86, in clause 90, page 50, line 32, at end insert—

“(da) cigarette filters;”.

This amendment enables the Secretary of State to make provisions about the retail packaging of cigarette filters and the composition of individual products contained in an individual pack of products outlined in Clause 90(1).

Amendment 87, page 51, line 13, at end insert—

“(ja) the composition of individual products contained in an individual pack;”.

This amendment enables the Secretary of State to make provisions about the retail packaging of cigarette filters and the composition of individual products contained in an individual pack of products outlined in Clause 90(1).

Amendment 36, page 51, line 30, delete “shape” and insert “design, shape or interoperability”.

This amendment empowers ministers to regulate the design and interoperability of products in order to prohibit the sale of very high-puff count vaping devices.

Amendment 37, in clause 92, page 52, line 3, after “flavour” insert “descriptors”.

This amendment would give the Secretary of State powers to make provisions about the flavour descriptors of relevant products.

Amendment 88, in clause 110, page 60, line 35, leave out from “consult” to end of line 36 and insert

“any persons or bodies as appear to him or her representative of the interests concerned.”

This amendment would ensure that the Secretary of State has to consult all relevant parties before making regulations, rather than just those that they deem appropriate.

Government amendment 80.

Amendment 90, in clause 114, page 63, line 16, after “product,” insert

“except for the public health purpose of promoting vaping as a cessation tool for existing tobacco smokers,”.

This amendment would allow vapes to be promoted as a quit-aid/public health measure.

Amendment 46, in clause 120, page 68, line 22, at end insert—

“(ca) it is, when in relation to the advertising of vaping products or nicotine products, in a location in which it would be reasonable to expect that everyone present is aged 18 or over.”

This amendment would allow for the advertising of vaping or nicotine products within locations where it is reasonable to expect that everyone present is over 18.

Amendment 91, in clause 125, page 73, line 2, at end insert—

“(4) No offence is committed under this Part if—

(a) it is for the purposes of an interaction between a representative for the product and a member of the public, and

(b) the representative for the product has taken reasonable measures to ensure that the member of the public is aged over 18 and is an existing tobacco or nicotine user.”

This amendment will allow for vapes and nicotine products to be promoted through one-to-one interaction between individuals representing the product and adults who are already existing smokers or nicotine users.

Amendment 85, in clause 136, page 77, line 8, leave out from “smoke-free” to end of line 15 and insert

“a place in England that is—

(a) an NHS property or hospital building,

(b) a children’s playground, or

(c) a nursery, school, college or higher education premises.”

This amendment restricts the Secretary of State to only being able to designate open or unenclosed spaces outside a hospital, children’s playground, nursery, school, college or higher education premises as smoke-free areas.

Amendment 84, page 77, line 9, leave out from “place” to the end of line 12 and insert

“or description of place in England that is not smoke-free under section 2.

(1A) The place, or places falling within the description, need not be enclosed or substantially enclosed.

(1B) The Secretary of State may designate a place or description of place under this section only if they are advised by the Department for Health and Social Care's Chief Scientific Adviser that there is a significant risk that, without a designation, persons present there would be exposed to significant quantities of smoke or, if said place is—

(a) an NHS property or hospital building,

(b) a children’s playground, or

(c) a nursery, school, college or higher education premises.”

This amendment would restrict the Secretary of State to only being able to designate open or unenclosed spaces outside a hospital, children’s playground, nursery, school, college or higher education premises, or places with significant risk of second-hand smoke as smoke-free areas.

Amendment 92, page 77, line 12, at end insert—

“(1A) The Secretary of State may designate a place or description of place under this section only if, in the Secretary of State’s opinion, there is a significant risk that, without a designation, persons present there would be exposed to significant quantities of smoke.”

This amendment provides that regulations to designate places as smoke-free may only be made if the Secretary of State is satisfied that they are necessary to avoid persons being exposed to significant quantities of smoke.

Amendment 82, in clause 137, page 78, leave out lines 5 to 12.

This amendment removes the proposed power for the Secretary of State to create defences for performances. This protects the health of actors in the workplace and prevents the promotion of smoking through artistic means.

Amendment 83, page 78, leave out lines 15 to 21.

This amendment removes the proposed power for the Secretary of State to create defences for performances. This protects the health of actors in the workplace and prevents the promotion of smoking through artistic means.

Amendment 93, in clause 139, page 79, line 13, at end insert—

“(1A) The Secretary of State may designate a place or description of place under this section only if, in the Secretary of State’s opinion, there is a significant risk that, without a designation, the use of vapes may have adverse effects on the health of persons present there who are not using vapes.”

This amendment provides that regulations to designate places as vape-free may only be made if the Secretary of State is satisfied that they are necessary to avoid persons present there being exposed to adverse health effects.

Amendment 94, in clause 140, page 82, line 24, at end insert—

“(1A) The Secretary of State may designate a place or description of place under this section only if, in the Secretary of State’s opinion, there is a significant risk that, without a designation, the use of heated tobacco devices may have adverse effects on the health of persons present there who are not using heated tobacco devices.”

This amendment provides that regulations to designate places as heated tobacco-free may only be made if the Secretary of State is satisfied that they are necessary to avoid persons present there being exposed to adverse health effects.

Amendment 95, in clause 142, page 85, line 33, at end insert—

“(2A) Premises may be prescribed as no-smoking premises only if in the Scottish Ministers’ opinion there is a significant risk that, without prescribing them, persons present there would be exposed to significant quantities of smoke.”

This amendment provides that regulations to prescribe premises as smoke-free may only be made if the Scottish Ministers are satisfied that they are necessary to avoid persons being exposed to significant quantities of smoke.

Amendment 96, in clause 144, page 90, line 4, at end insert—

“(2A) Premises may be prescribed as vape-free premises only if in the Scottish Ministers’ opinion there is a significant risk that, without prescribing them, the use of vapes may have adverse effects on the health of persons present there who are not using vapes.”

This amendment provides that regulations to prescribe premises as vape-free may only be made if the Scottish Ministers are satisfied that they are necessary to avoid persons present there being exposed to a significant risk of adverse health effects.

Amendment 97, in clause 145, page 92, line 22, at end insert—

“(2A) Premises may be prescribed as heated tobacco-free premises only if in the Scottish Ministers’ opinion there is a significant risk that, without prescribing them, the use of heated tobacco devices may have adverse effects on the health of persons present there who are not using heated tobacco devices.”

This amendment provides that regulations to prescribe premises as heated tobacco-free may only be made if the Scottish Ministers are satisfied that they are necessary to avoid persons present there being exposed to a significant risk of adverse health effects.

Amendment 98, in clause 150, page 98, line 40, at end insert—

“(2A) The regulations may designate a place or vehicle as vape-free only if the Welsh Ministers are satisfied that doing so is likely to contribute towards the promotion of public health.”

This amendment provides that regulations to designate a place or vehicle as vape-free may only be made if the Welsh Ministers are satisfied that this is likely to contribute towards the promotion of public health.

Amendment 99, in clause 151, page 105, line 22, at end insert—

“(2A) The regulations may designate a place or vehicle as heated tobacco-free only if the Welsh Ministers are satisfied that doing so is likely to contribute towards the promotion of public health.”

This amendment provides that regulations to designate a place or vehicle as heated tobacco-free may only be made if the Welsh Ministers are satisfied that this is likely to contribute towards the promotion of the health of the people of Wales.

Amendment 100, in clause 153, page 108, line 25, at end insert—

“(1A) The Department may designate a place or description of place under this Article only if satisfied that, without the designation, persons present there would be likely to be exposed to significant quantities of smoke.”

This amendment provides that regulations to designate places as smoke-free may only be made if the Northern Ireland Department is satisfied that they are necessary to avoid persons being exposed to significant quantities of smoke.

Amendment 101, in clause 155, page 110, line 6, at end insert—

“(1A) The Department may designate a place or vehicle under this Article only if the Department is satisfied there is a significant risk that, without a designation, the use of vapes may have adverse effects on the health of persons present there who are not using vapes.”

This amendment provides that regulations to designate places as vape-free may only be made if the Northern Ireland Department is satisfied that they are necessary to avoid persons present there being exposed to adverse health effects.

Amendment 102, in clause 156, page 113, line 15, at end insert—

“(1A) The Department may designate a place or vehicle under this Article only if the Department is satisfied there is a significant risk that, without a designation, the use of heated tobacco devices may have adverse effects on the health of persons present there who are not using heated tobacco devices.”

This amendment provides that regulations to designate places as heated tobacco-free may only be made if the Northern Ireland Department is satisfied that they are necessary to avoid persons present there being exposed to adverse health effects.

Amendment 89, in clause 168, page 120, line 39, leave out from “force” to end of line 41 and insert

“on such a date as the Secretary of State may by regulation appoint following the consultation on licensing regulations (see section (Consultation on licensing regulations)).”

See explanatory statement for NC18.

Government amendment 81.

Amendment 26, in schedule 5, page 132, line 2, leave out

“a anwyd ar neu ar ôl 1 Ionawr 2009”

and insert “dan 21 oed”.

This amendment is linked to Amendment 4.

Amendment 27, page 132, line 7, leave out

“a anwyd ar neu ar ôl 1 Ionawr 2009”

and insert “dan 21 oed (“B”)”.

This amendment is linked to Amendment 4.

Amendment 28, page 132, line 12, leave out

“a anwyd ar neu ar ôl 1 Ionawr 2009”

and insert “dan 21 oed”.

This amendment is linked to Amendment 4.

Amendment 29, page 132, line 38, leave out

“wedi cael ei eni cyn 1 Ionawr 2009”

and insert

“yn 21 oed neu drosodd”.

This amendment is linked to Amendment 4.

Amendment 30, page 133, line 2, leave out

“wedi cael ei eni ar neu ar ôl 1 Ionawr 2009”

and insert “dan 21 oed”.

This amendment is linked to Amendment 4.

Amendment 111, page 133, line 15, leave out paragraph 5.

This amendment is linked to Amendment 103.

Amendment 31, page 133, line 16, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 4.

Amendment 32, page 133, line 21, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 4.

Amendment 33, page 133, line 26, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 4.

Amendment 45, page 133, line 37, at end insert—

“(1A) In this section, “tobacco products” means cigarettes or hand rolling tobacco within the meaning of the Standardised Packaging of Tobacco Products Regulations 2015 (S.I. 2015/829).”

This amendment is linked to Amendment 38.

Amendment 34, page 134, line 9, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 4.

Amendment 35, page 134, line 14, leave out

“born on or after 1 January 2009”

and insert

“under the age of 21”.

This amendment is linked to Amendment 4.

[Ashley Dalton]

I would like to start by thanking all right hon. and hon. Members for their invaluable contributions during the passage of the Bill to date, and in particular, members of the Public Bill Committee for providing insight, scrutiny and debate. I am honoured to have taken on responsibility for this Bill. It is a watershed piece of legislation and the most significant public health intervention since the ban on smoking in public places in 2007. It will establish a smokefree generation by gradually ending the sale of tobacco products across the UK so that a child turning 16 this year will never be able to be legally sold tobacco, saving countless lives in the process. It will strengthen existing powers to reduce the harms of second-hand smoke in public spaces. In keeping with our manifesto commitment to the British people, it will outlaw the manipulative promotion of vapes to children to protect the next generation from becoming hooked on nicotine. Finally, it will implement robust measures to strengthen enforcement activity.

I do not need to tell anyone in this Chamber that tobacco kills—we all know that. What hon. Members may not know is just how much it kills, the rate at which it kills, and the devastation it causes for individuals, families and communities across the country. Let me remind hon. Members that tobacco kills more people than any other preventable cause of death. Around 80,000 people in the UK lose their lives to tobacco every year. It robs an average of 10 years off the life expectancy of smokers. It substantially increases the risk of many major health conditions throughout people’s lives, such as stroke, diabetes, heart disease, stillbirth, dementia and asthma. This daily tragedy continues unabated, with someone being admitted to hospital because of smoking almost every minute, day in, day out, with no end in sight.

Tobacco harms are not felt equally either. Our most disadvantaged communities suffer most, with 230,000 households living in smoking-induced poverty. In Blackpool, 17.5% of pregnant women still smoke at the time of delivery compared with 2.8% in Kensington and Chelsea. Over a quarter of people with a long-term mental health condition smoke.

Beyond the immeasurable cost to lives in the UK, the staggering economic impact of tobacco on our NHS cannot be ignored. The treatment of smoking-related diseases consumes approximately £3 billion a year of vital NHS and social care resources. The cost of smoking to our economy is even greater: £18 billion is lost in productivity every year, far outweighing the tax receipts it brings in of around £9 billion. The Bill is a vital step to break the devastating cycle of tobacco addiction and safeguard future generations from a lifetime of ill health.

But the world moves forward, and we cannot ignore the alarming rise of youth vaping. While vaping is less harmful than smoking and can be an effective quit aid for adult smokers, children should never vape. However, in the past five years, youth vaping has more than doubled. One in four 11 to 15-year-olds tried vaping in 2023, and that is no accident. It is in part due to the deliberate branding and advertisement of vapes to our children, with brightly coloured packaging and enticing sweet-like flavours—a calculated strategy to hook young people on nicotine. We cannot afford to wait to act.

I turn to the Government amendments, which seek to strengthen the Bill and ensure greater clarity. As we create the first smokefree generation and strengthen age restrictions on vapes and nicotine products, we want to support retailers in taking appropriate steps to ensure they do not sell to customers under the age of sale. New clause 11 and Government amendments 47 to 49, 51 to 53, 61, 63, 65 to 67, 69 to 71, 75, 77, 79 and 81 are a package of amendments and consequential amendments to the Bill. They seek to remove potential ambiguity for retailers regarding the use of digital identity for verifying the age of prospective customers when selling tobacco, vaping and nicotine products.

In Committee, Members raised concerns that the list of identity documents to satisfy the defence for a person charged with selling products to someone under the age of sale was limited, and queried the inclusion of other forms of physical and digital identity. These amendments remove the lists of physical ID from the Bill and instead provide powers for the Secretary of State and the Department of Health in Northern Ireland to specify in regulations the steps that may be taken to verify a customer’s age to meet the requirements for the defence. This revised approach better future-proofs the defence against developments in identification processes and provides the potential to recognise digital ID, as well as physical ID, in the context of the defence, supporting the widespread use of digital ID.

The amendments provide the opportunity for effective interaction with part 2 of the Data (Use and Access) Bill that is currently going through Parliament, which includes provisions relating to digital verification services. Digital verification services provide an opportunity to securely verify age for in-person and online sales. We will continue to work closely with the Department for Science, Innovation and Technology and other Departments when developing the regulations.

New clause 11 provides a similar power for Scottish Ministers to prescribe in regulations the steps that should be taken to establish a customer’s age as a defence to an age of sale offence. That will enable Scottish Ministers to respond to changes in technology and consumer behaviours, which may move away from the presentation of a physical document.

The last Labour Government took bold action to prohibit displays of tobacco products to protect children and young people from being enticed into addiction and to create a more supportive environment for adults seeking to quit. The Bill goes further and gives powers to limit the display of a wider range of products, including herbal smoking products, cigarette papers, vapes and nicotine products. Government amendments 56, 57, 60, 62, 74, 76, 78 and 80 will alter the powers in the Bill for England, Wales and Northern Ireland that regulate displays of products and their prices, so that they also cover tobacco-related devices. As was discussed in Committee, pipes, heated tobacco devices and bongs are currently displayed in shops and can have the effect of promoting tobacco usage. The amendments will ensure that we can make regulations to stop products that facilitate the consumption of tobacco being openly displayed by retailers.

The Bill bans the sale of vapes, nicotine products and cigarette papers from vending machines in England, Wales and Northern Ireland and restates the existing ban on tobacco vending machines. We know that vending machines are used to bypass age of sale restrictions and to undertake proxy purchases on behalf of people under the age of sale. Government amendments 50, 54, 55, 64, 68, 72 and 73 are clarifying amendments that make the scope of the prohibition on vending machines absolutely clear, as was discussed in Committee. The Government’s position is that the Protection from Tobacco (Sales from Vending Machines) (England) Regulations 2010 already apply where a customer has a coupon, receipt or token purchased elsewhere that can be redeemed at a machine. We are amending the clauses so that all machines that dispense products in connection with a sale are clearly captured by the ban.

The Bill strengthens the enforcement regime to support law-abiding retailers while taking action against those who break the rules. Along with introducing new fixed penalty notices and new powers to create a licensing system, the Bill re-enacts provisions on restricted premises orders and restricted sale orders. Those are existing measures that local authority trading standards in England and Wales can use when dealing with a retailer that persistently breaches restrictions. That ensures there is a range of tools in the enforcement armoury, so that trading standards officers can act quickly and effectively against rogue retailers.

Government amendments 58 and 59 clarify a point raised in Committee by removing a duplicative and unnecessary provision that would prevent a business or individual from operating a vending machine for the sale of tobacco, vaping or nicotine products following the issuing of a restricted premises order or a restricted sale order. Given that the Bill already prohibits the use of vending machines for tobacco, vaping or nicotine products, there is no need for restricted premises orders and restricted sale orders to expressly prohibit the use of vending machines. Together, the Government amendments will improve the implementation and enforceability of measures in the Bill to ensure the most effective protection for the public, and I commend them to the House.

Turning to the other amendments in the group, I thank hon. Members for their scrutiny of the Bill so far. When I wind up, I will try to cover the key themes that are touched on. On the amendment that seeks to undermine the smokefree generation, I am sure we will hear arguments from some hon. Members who have been listening to the tobacco industry’s arguments and myths about how people should be free to make their own choices. I would say to them that smoking kills two thirds of its users. Three quarters of people wish they had never started smoking, and the majority want to quit—that is not freedom of choice. The tobacco industry took away that choice with addiction, usually at a young age.

On smokefree places, we have been clear: in England, we intend to consult on extending smokefree outdoor places to outside schools, children’s playgrounds and hospitals, but not to outdoor hospitality settings at this time. No smoker wants to harm people, but with second-hand smoke, they do. If people can smell smoke, they are inhaling it. This is particularly important for children, pregnant women and people with pre-existing health conditions such as asthma or heart disease. The only way to stop this harm is to stop people smoking around others. While I understand hon. Members’ proposals to list specific places in the Bill or to add additional limits to the use of the powers, it is right that we consult on the detail before making regulations and have the necessary powers to protect children and vulnerable people from the harms of second-hand smoking.

I am grateful to the co-chairs of the all-party parliamentary group on smoking and health, my hon. Friend the Member for City of Durham (Mary Kelly Foy) and the hon. Member for Harrow East (Bob Blackman), for their long-standing support for the Bill. Through their amendments, they highlight the importance of retaining a focus on support for current smokers. That is why we are investing an extra £70 million for local stop smoking services this year and working to ensure that all NHS hospitals offer opt-out smoking cessation services into routine care. I hope they will be pleased that we have been able to confirm the extension of the swap to stop scheme for the coming year, with up to £90 million of funding to provide free vape starter kits for smokers to use as quit aids.

On the group of amendments relating to vape advertising, we realise that products being deliberately marketed at children is unacceptable, which is why we have included a commitment to stop vapes being branded and advertised to children. The Government are also investing £10 million of new funding for the coming year for National Trading Standards to tackle underage illicit tobacco and vapes and to boost the trading standards workforce by recruiting 80 new apprentices, providing additional boots on the ground.

[Mr Joshua Reynolds (Maidenhead) (LD)]

Trading standards are really important and obviously, therefore, so are fixed penalty notices, so will the Minister support amendment 1, which would mean that any fixed penalty notice sums will be retained by local authorities to spend on public health, thus saving the NHS money, as she mentioned earlier?

[Ashley Dalton]

As the hon. Member will know, there are already measures in the Bill that allow some of the fines to be retained—they can certainly be retained to make it cost-neutral for local authorities—but I am sure we will explore that issue later on.

The Bill contains regulation-making powers on a range of aspects of product requirements that already allow us to do many things that hon. Members seek to achieve, but I look forward to listening to the contributions to today’s debate on the wider list of amendments and to responding to the points that are made.

[Madam Deputy Speaker (Judith Cummins)]

I call the Opposition spokesperson.

--- Later in debate ---

[Mrs Brackenridge]

I am pleased to say that that will end with the Bill, which will ban vape advertising aimed at children, outlaw sales from vending machines and crack down on packaging designed to attract young eyes. Firm action to protect the health of children includes a £10 million boost for trading standards to fund more enforcement officers.

I welcome the recent announcement of the £62 million groundbreaking research to investigate the long-term health effects of vaping by tracking 100,000 young people aged eight to 18 over a decade. Unless we prevent illness, our NHS will continue to be overwhelmed, and billions of pounds will be spent addressing a problem that could have been curbed in advance. I call on the House to pass the Bill in order to protect children in Wolverhampton East and across the country.

[Ashley Dalton]

Let me begin by thanking all hon. and right hon. Members for their contributions. I will try and touch on the many amendments discussed and the key questions raised.

At the heart of the Bill is the establishment of the smokefree generation by gradually ending the sale of tobacco products across the UK. Amendments 4 to 35 tabled by the right hon. Member for East Antrim (Sammy Wilson), amendments 38 to 45 tabled by the hon. Member for Romford (Andrew Rosindell), amendments 103 to 111 tabled by the hon. Member for Clacton (Nigel Farage) and new clause 12 tabled by the right hon. Member for South Holland and The Deepings (Sir John Hayes) would remove that policy or water it down. There is no liberty or choice in addiction, however, and that is why the Government are committed to creating the world’s first smokefree generation. We have the public’s backing, with 71% of adults supporting the goal of a smokefree Britain in a YouGov poll carried out in November 2023. Raising the age of sale to 21 will not meet our ambition to make the UK smokefree.

--- Later in debate ---

[Wera Hobhouse]

I hear what the Minister is saying, but the Metropolitan police and other forces tell us that it is incredibly difficult. The Bill gives us an extra opportunity to protect young children from a terrible pathway into addiction and crime. Is it not the task of this Government to stop that?

[Ashley Dalton]

The entire Bill is about preventing addiction among our young people and preventing their move into crime. These things are already illegal and the Government believe that existing legislation will allow for them to be dealt with.

On cigarette filters, I understand hon. Members’ concerns about tobacco litter, but new clause 2, tabled by the hon. Member for Gosport (Dame Caroline Dinenage), could lead to greenwashing, improving the reputation of tobacco manufacturers while not necessarily improving environmental outcomes.

[Dame Caroline Dinenage]

That is an incredibly lazy argument. We do not care about greenwashing; greenwashing is just semantics. We care about cleaning up our beaches, cleaning up our streets and reducing the cost to local councils of cleaning up litter. It is ridiculous if the Government are going to be swayed by one lobby or another and not do the thing that is common sense and much better for our environment.

[Ashley Dalton]

I thank the hon. Member for her intervention. If I am allowed to finish, that is one of the issues and that proposal may not necessarily improve environmental outcomes. However, we consider that powers are already available to the Department for Environment, Food and Rural Affairs that enable the Government to limit the damage to the environment caused by filters, so the amendments are unnecessary.

Similarly, new clause 14, tabled by my hon. Friend the Member for Dartford (Jim Dickson), would prohibit the supply of all cigarette filters or cigarettes containing filters, whether they contain plastic or not. Ultimately we believe that the best way to tackle filters is through the reduction of smoking rates. On bundles of tobacco products, the Bill gives the Government the powers to regulate retail packaging of tobacco products and devices, herbal smoking products and cigarette papers, as well as vaping and nicotine products. In addition, the Bill already gives the Government powers to regulate how products are packaged together in bundles, so amendments 86 and 87, also tabled by my hon. Friend, are not necessary.

Amendments 46, 90 and 91 and new clauses 8 to 10 and 15 would all undermine our promise to the electorate to stop vapes being advertised to children. We have a clear mandate, with 74% of adults in Great Britain supportive of a ban, and we will not create any exemptions that could undermine this. On amendment 90 and new clause 15, let me reassure the shadow Secretary of State and my hon. Friend the Member for Newcastle upon Tyne East and Wallsend (Mary Glindon) that the Government are not prohibiting the promotion of vapes in general as a smoking cessation tool.

Let me reassure my hon. Friends the Members for Newcastle upon Tyne East and Wallsend and for Suffolk Coastal (Jenny Riddell-Carpenter) that the Bill already provides the Government with powers to limit the amount of nicotine in a nicotine pouch, to regulate vaping products in such a way that would prohibit the sale of high puff count vaping devices, including setting tank capacity limits for devices where multiple refill tanks are attached, and to ban any other ingredient that may be harmful. The Government believe that these measures are more appropriate for secondary legislation due to the technical details that need to be captured, rather than in primary legislation as new clauses 4 and 21 would require.

On amendment 37, tabled by my hon. Friend the Member for Newcastle upon Tyne East and Wallsend, we recognise that vape flavours are a really important consideration for adult smokers seeking to quit smoking, but we also know that sweet or fruity flavours are the main flavours that appeal to children and that certain flavours and ingredients can be particularly harmful to health. We have been clear that we will carefully consider our future regulations so that we get the balance right, and this is subject to a statutory duty to consult. Similarly, I reassure my hon. Friend that amendment 88 is unnecessary. We will honour the long-established principles of good consultation when consulting on regulations under part 5 of the Bill, including in relation to who is consulted.

On new clauses 6 and 7, while the Government are committed to protecting children from the risk of harms through addiction, our approach across all products in the Bill is for age to be verified at the point of sale, not at the point of use. Mandating any age-gating technology for vapes would create harsher restrictions on vaping than smoking. That could make vapes less accessible and attractive to adult smokers wishing to quit and use vapes as a smoking cessation tool.

I recognise the concerns of the hon. Member for Harrow East (Bob Blackman) about online sales. However, it would not be proportionate to ban all online sales because that would impact on those retailers seeking to operate within the law.

As was discussed in Committee, going back to the issue of wider enforcement, new clause 18 and amendment 89 do not reflect the complex processes required to develop the licensing scheme in England and Wales. Although I am sympathetic to the shadow Secretary of State’s aims, rushing to publish draft regulations within two months of Royal Assent would risk creating flawed policy.

I pay tribute to colleagues in the Scottish Government, Welsh Government and the Northern Ireland Executive. This UK-wide Bill has been developed in partnership with them, and I thank them for their support. Our manifesto committed to resetting our relationship with the devolved Governments, and this Bill is a great success in demonstrating collaboration across Governments in improving the health of the nation.

[Jim Allister]

Since the tobacco directive applies to Northern Ireland under the protocol through section 7A of the 2018 Act and applies directly, and the directive forbids the type of proposition in this Bill, would the Minister care to explain to the House how this Bill will be applicable in Northern Ireland as long as the tobacco directive applies?

[Ashley Dalton]

This Bill has been put together, as I said, with collaboration across all the Governments and bearing in mind all the Government’s legal obligations under the law. All those things have been taken into account, and the Bill is able to be brought forward in that way. Our manifesto committed to delivering the smokefree generation, and we are working across all Governments to ensure that we deliver that, as well as honouring our international obligations. As a result, the Government do not consider new clause 3 tabled by the hon. and learned Member for North Antrim (Jim Allister) to be necessary. That is because we are content that measures drafted in the Bill that apply in relation to Northern Ireland are consistent with our obligations under the Windsor framework, and the proposed new clause would put us in breach of international law. In the drafting of the Bill, as I have stated, we have considered all its domestic and international obligations, and it is for those reasons that the Government cannot support new clause 3.

The Bill will bring about a real change by creating a smokefree generation. As we have discussed, there is no liberty or choice in addiction, and almost all smokers want to quit and two thirds wished they had never started. I started smoking at the age of 16 and decided I would stop when I was 18—I could not stop. I thought, “I know, I’ll stop when I am 21” and then it was 25, then it was when I graduated, and then it was when I had a child. At no point was I able to give up this pernicious addiction. It took a cancer diagnosis to scare me into being able to stop smoking, and I do not wish that on any of our young people.

In conclusion, many of the amendments are unnecessary because the Bill already grants the Government the power to take forward the issue through the more appropriate route of secondary legislation. This is a landmark Bill: the most significant public health intervention in a generation. It strikes the right balance on the interests of public health by being proportionate and not overly burdensome. It allows the Government to bring forward the appropriate primary and secondary legislation to ensure that we can deliver a smokefree generation that protects all our children from the addiction of tobacco, a uniquely harmful substance.

--- Later in debate ---

[Ashley Dalton]

I beg to move, That the Bill be now read the Third time.

Let me start by thanking hon. Members on both sides of the Chamber for their positive and constructive engagement today and more generally as the Bill has progressed through the House. Let me put on record my sincerest thanks to all members of the Public Bill Committee, who scrutinised the Bill extremely thoroughly and brought it to this stage.

The Bill is the next step in a long history of action on tobacco, but as the House is aware, it is not a step that this Labour Government have taken alone. I thank the right hon. Member for Richmond and Northallerton (Rishi Sunak) for his ambition to make a difference to the future of our country by championing the previous Tobacco and Vapes Bill. The Bill that we are discussing today is even stronger in its ambition to tackle smoking and youth vaping, in part thanks to the contributions and debate from MPs from all parties on these most critical of issues.

I thank the Opposition Front Benchers for their engagement with the Bill, particularly the shadow Minister, the hon. Member for Sleaford and North Hykeham (Dr Johnson), who has been a determined campaigner for action on youth vaping for a number of years. I also thank my officials in the Department for Health and Social Care and the devolved Governments, the Office of the Parliamentary Counsel, the Government Legal Department and the Clerks, whose tireless work and support on the Bill have enabled the development of this extraordinary legislation.

When this Government took office, we promised to create a smokefree generation. Today we are delivering on that promise. By creating a smokefree UK, we are investing in a healthier society for all. The Bill will tackle the concerning rise in youth vaping and reduce the immense burden that tobacco-related illnesses place on our society and our NHS. I consider it a great privilege to have overseen these last parts of scrutiny of the Bill, and I urge all right hon. and hon. Members to support it to proceed to the other place.

Oral Answers to Questions

Ashley Dalton Excerpts

Tuesday 25th March 2025 Commons Chamber

[Max Wilkinson (Cheltenham) (LD)]

5. What steps his Department is taking to improve cancer care in the west of England.

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

I know the hon. Member is acutely aware of the impact that cancer can have on families. We are committed to catching cancer earlier and treating it faster. We have achieved our manifesto pledge of 2 million extra appointments seven months early and we have invested in more surgical hubs, longer opening times, which have benefited 23 community diagnostic centres in the south-west, and new radiotherapy machines. The national cancer plan will also seek to improve every aspect of cancer care to improve patient outcomes and experiences across the country, including in the west of England.

[Max Wilkinson]

I thank the Minister for her answer. The Big Space Cancer Appeal being run by the Cheltenham and Gloucester Hospitals Charity is going on in my constituency. It is having to raise £17.5 million for a new cancer centre at Cheltenham general hospital, which is a regional cancer centre, because the previous Government did not fund it. I am proud of the fund-raising work that is being done by the hospitals charity, including by my caseworker, Mateusz, who is running two half marathons for the cause. Will the Minister meet me and Dr Sam Guglani and Dr Charles Candish to discuss how the Government might provide more support for this crucial piece of infrastructure?

[Ashley Dalton]

I commend the hon. Member’s campaign activity for improved cancer facilities. I commend, too, Mateusz’s two half-marathons. I wonder when the hon. Member will be doing his half-marathon, but I can guarantee that I will not be joining him. The fact that this sort of activity is taking place is fantastic. Local provision for healthcare is managed by the local health system. I would be delighted to meet him and local representatives as soon as diaries allow.

[Steve Yemm (Mansfield) (Lab)]

Cancer care is important for people right across the UK, particularly early diagnosis. How do the Government plan to raise cancer awareness among young people during Teenage and Young Adult Cancer Awareness Month and ensure that they are fully aware of the signs and symptoms?

[Ashley Dalton]

This is a really important issue. We have reinstated the children and young people cancer taskforce, which I visited a couple of weeks ago. We have tasked it with ensuring that children and young people are a part of its work. The Department will be marking Teenage and Young Adult Cancer Awareness Month appropriately. We encourage all children and young people to get the checks that they need and be aware of cancer symptoms.

[Kevin McKenna (Sittingbourne and Sheppey) (Lab)]

6. What steps his Department is taking to help tackle inequalities in nursing career progression.

--- Later in debate ---

[Sarah Smith (Hyndburn) (Lab)]

13. What steps he is taking to ensure special educational and disability needs are met by the NHS.

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

I commend my hon. Friend for her dedication to improving support for children in her role as the opportunity mission champion. Children with special educational needs and disabilities may access a range of NHS services, including health assessments and specialised support. All integrated care boards must have an executive lead for SEND to ensure that that work receives sufficient focus. We are working closely with the Department for Education on reforms to the SEND system.

[Sarah Smith]

As the Minister is aware, last year we faced the devastating closure of the Accrington Victoria hospital after 14 years of mismanagement by the Conservative party. I place on record my thanks to the frontline staff who have managed that transition and the operational challenges to relocate services, but sadly a fully purposed building for children with SEND had to be used to relocate clinical services. How does the Minister plan to ensure that those with SEND are at the heart of commissioning plans and service development?

[Ashley Dalton]

The system we inherited has been failing to meet the needs of children with SEND for far too long—that became clear in what happened at the Accy Vic. Through the 10-year health plan, we will consider all those policies, including those that impact on children and young people. We are working closely with the Department for Education to support the delivery of the opportunity mission. I also hosted a roundtable recently with children and young people, including those with SEND, so that they can feed directly into the 10-year plan. They will be at the heart of our thinking and planning on these issues.

[Graham Stuart (Beverley and Holderness) (Con)]

Mr Speaker, your heart would have been gladdened last week to see colleagues from across the House coming together to support my debate calling for the Down Syndrome Act 2022 to be implemented three years on. The Minister for Secondary Care said in response that Down syndrome-specific guidance would be produced, which is welcome. Will the Minister ensure that the consultation group is restricted to organisations that represent Down syndrome people only, and will she promise that, after three long years, that statutory guidance will finally be issued before the end of this calendar year?

[Ashley Dalton]

Work to develop the Down Syndrome Act statutory guidance is being taken forward as a priority, with a view to publishing it for consultation by the summer. It does involve people with Down syndrome, as part of a wider group.

--- Later in debate ---

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

I commend my hon. Friend’s constituent for her work with the Brain Tumour Charity, and I wish Lily well with her treatment. The Government have launched the brain tumour research consortium, which will support efforts to speed up the diagnosis of tumours and aid the recovery of patients, and the national cancer plan will ensure that we include brain tumour patients. We know that everyone’s cancer is as unique as they are, and this will be reflected in the plan.

[Andrew George (St Ives) (LD)]

T4. In reviewing the NHS workforce plan, will Ministers urgently review the pay and status of registered nurses, who are, after all, the backbone of the NHS? Many are now dependent on food banks, thousands are saddled with student debt, and most will expect never to rise beyond band 5, which is a maximum of £35,000 a year.

--- Later in debate ---

[Euan Stainbank (Falkirk) (Lab)]

Last year, my constituent Danielle was diagnosed with POTS—postural orthostatic tachycardia syndrome. She found herself unable to get out of bed and unable to speak for long periods. She could not receive care in Scotland. Specialist treatment does not seem to exist for POTS. What more can we do for people like Danielle, and what conversations has the Minister had with counterparts about establishing specialist treatment in Scotland?

[Ashley Dalton]

In England, it is the responsibility of local integrated care boards to work with clinicians, service users and patient groups to develop services and care pathways that are convenient and meet the needs of patients with POTS. NICE has published a clinical knowledge summary on the clinical management of blackouts and syncope, which provides advice for UK clinicians on best practice and the assessment and diagnosis of POTS.

[Charlie Dewhirst (Bridlington and The Wolds) (Con)]

I have twice invited Ministers to visit Bridlington district hospital with me to see its much-underutilised potential. In the light of the ongoing challenges faced by coastal and rural health services and the newly announced changes to integrated care boards, may I hope that it will be third time lucky, and extend that invitation once again?

--- Later in debate ---

[Tom Hayes (Bournemouth East) (Lab)]

Coastal constituencies such as mine in Bournemouth East suffer significant health inequalities. What are the Government doing to address them, and will the Minister meet me and coastal Labour MPs to address the issue?

[Ashley Dalton]

My hon. Friend is right: coastal communities face unique challenges when it comes to health inequalities. I will shortly attend the all-party group for coastal communities, where I will meet him and colleagues to discuss these issues.

[Charlie Maynard (Witney) (LD)]

As the Secretary of State will know, in 2018, this House allocated £40 million of funding in memory of Dame Tessa Jowell, who was killed by a brain tumour. Seven years on, less than half of that money has been spent. The money is doing no good sitting in a bank, so will the Secretary of State please commit to spending that money within a decade of Dame Tessa’s death?

World Health Organisation Pandemic Accord Negotiations

Ashley Dalton Excerpts

Tuesday 18th March 2025 Written Statements

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

I would like to update the House regarding the latest round of negotiations on a legally binding international agreement on pandemic prevention, preparedness and response—the pandemic accord—at the World Health Organisation (WHO).

In March 2021, the UK joined other WHO member states in calling for a pandemic accord that would ensure the world is better prepared for any future pandemic. Negotiations on the pandemic accord have been ongoing since 2022, and member states have until the World Health Assembly in May 2025 to reach an agreement.

The pandemic accord aims to enable a better co-ordinated, global response to pandemic threats and facilitate more equitable and timely access to pandemic-related vaccines, treatments, and tests. With a future pandemic a certainty, the pandemic accord is an opportunity to better protect the UK against this threat and to deliver on the Government’s health and growth missions, including through improving pandemic prevention, promoting innovation in pandemic related research and development (R&D), and putting in place systems that can promptly respond to pandemic threats when they emerge. The UK will only sign up to a pandemic accord which is both in the national interest and protects the health of people in the UK and around the world.

Member states have reached provisional agreement on around 75% of the text, while negotiating on the principle that “nothing is agreed until everything is agreed”. Since the House was last updated in November, provisional agreement has been reached on articles covering sustainable financing for the implementation of the agreement, and R&D. During the latest round of negotiations, between 17 and 21 February, some progress was made on portions of the text covering pandemic prevention, the opening chapter of the accord (covering definitions, objectives, and principles), and pathogen access and benefit sharing (PABS). However, there is still some way to go on several issues, including on technology transfer and further areas within the pandemic prevention and PABS articles, with limited time remaining to negotiate the text. The UK Government remain committed to working with member states to reach an effective agreement.

I will continue to update the House as negotiations near conclusion.

[HCWS529]

Rare Cancers Bill

Ashley Dalton Excerpts

2nd reading
Friday 14th March 2025 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Ashley Dalton)]

First, let me say how sorry I was to hear that my hon. Friend the Member for Edinburgh South West (Dr Arthur) recently lost his father-in-law to glioblastoma. I congratulate him on introducing this legislation less than a year after his election. His wife and children will be immensely proud to see him in the Chamber today. He has the full support of many charities, such as Pancreatic Cancer UK, the Brain Tumour Charity and Cancer Research UK, as well as people up and down the country who have written to their MP urging them to join this debate and vote for the Bill.

I also pay tribute to all those right hon. and hon. Members who have lost loved ones and remembered them so powerfully today. I thank them for the courage that they have shown in sharing their stories. Particularly, I do not think that anyone in this Chamber or watching from the Gallery or beyond could have failed to be moved by the powerful stories from my hon. Friends the Members for Calder Valley (Josh Fenton-Glynn), for Cumbernauld and Kirkintilloch (Katrina Murray) and for Mitcham and Morden (Dame Siobhain McDonagh), to whom I give particular thanks for her tireless campaigning on glioblastoma following the untimely loss of her sister Margaret.

I also pay tribute to those who remembered their constituents. I am delighted that very soon I will be meeting my hon. Friend the Member for Hyndburn (Sarah Smith) and Lorraine to discuss Milly’s Smiles. Let me take the opportunity to add my memories of Joe Chilcott, the son of my friends Tim and Verity and sister to Ellie, who was diagnosed with a brain tumour at the age of 10. It was heartbreaking to lose him when he was just 18.

I thank all the hon. Members who have spoken today. I will seek to address as many of the issues raised as possible. There were so many stories. I recognise the people who were remembered in those stories, those in the Gallery, and the many more watching at home. They are willing the Bill to succeed. On behalf of the Government, it is my great pleasure to pledge our support for the Bill. We are undertaking fundamental reform of the NHS. People living with rare cancers must be at the heart of that change. Rare cancer patients deserve better, and the Bill gives them something that has been spoken about across the House today: new hope.

Let me begin my remarks on what the Bill will do, why we support it and our policy on rare cancers more generally. Clinical research is one of the most important ways in which we can improve healthcare, by identifying the best way to prevent, diagnose and treat cancer. The Bill will encourage the placement of clinical trials for rare cancer in England, by ensuring that the patient population can easily be contacted by researchers, streamlining the recruitment process. It will also ensure a Government review of regulations relevant to orphan drug designation, to ensure that they continue to deliver for patients. Innovations in the Bill will complement the radical actions that we are developing through the 10-year health plan and the national cancer plan to fix the NHS, on which I will expand later.

Research is a key part of this effort, which is why the Department of Health and Social Care, through the National Institute for Health and Care Research, invests more than £1.6 billion a year in health research. In 2023-24, the NIHR invested £133 million in cancer research. As we have heard, rare brain cancers such as glioblastoma have a devastating impact on people and their loved ones. That is why the NIHR announced in September 2024 a new package of funding opportunities for brain cancer research, and established in December a new national brain tumour research consortium, bringing together researchers from a wide range of different disciplines. That is in parallel with a dedicated funding call for research into wraparound care and the rehabilitation and quality of life of patients with brain tumours. We remain committed to accelerating new breakthroughs in high-quality research to drive improvement in the diagnosis, management and treatment of brain and other rare cancers, for better survival rates and patient outcomes.

The hon. Member for Esher and Walton (Monica Harding), my hon. Friend the Member for Mitcham and Morden and others asked how the £40 million promised for brain tumours has been spent. In the five years since 2018-19, the NIHR has invested £11.3 million directly in brain cancer, with a further £31.5 million to enable brain tumour research in 227 studies involving 8,500 people. The commitment remains in place. I can confirm that there is no upper limit on that funding. We are exploring additional research policy options to encourage more clinical trials in early phase research and the development of medical devices and diagnostics.

We have also talked a lot about other rare cancers, including lobular breast cancer, for which we are supporting research through the research infrastructure, including biomedical research centres. We welcome further funding applications for research on all conditions, including lobular breast cancer. We continue to consider whether abbreviated forms of breast magnetic resonance imagining —fast MRI—can detect breast cancers that are missed by screening through mammography, such as lobular and the other types of breast cancers that have been mentioned. We are also supporting the opening of 171 studies on blood cancer, providing an online registry called “Be Part of Research”, which allows users to search for and participate in studies relevant to them.

Clinical trials are a crucial part of cancer research. They provide patients with early access to groundbreaking and possibly lifesaving treatments. The measures in the Bill align strongly with our commitment to that, and aim to streamline clinical trial recruitment processes. My hon. Friend the Member for Mitcham and Morden spoke passionately about how long it takes trusts to negotiate contracts. We recognise that issue and are beginning to make progress. NHS commercial contracting has been standardised, and the national contract value review has reduced study set-up times by 36%, from 305 days to 194 days in the first 12 months’ analysis. We continue in that work.

The hon. Member for Wokingham (Clive Jones) and my hon. Friend the Member for Bootle (Peter Dowd) asked how we are working across borders. We are taking forward the most significant reform of UK clinical trial regulations in over 20 years, while maintaining robust protections and safeguarding for clinical trial participants. The MHRA already authorises cross-border clinical trials, including those conducted in the EU and on UK-based trial sites. The “Be Part of Research” programme uses information from national and international sources.

My hon. Friend the Member for Mitcham and Morden spoke so passionately—we have all commented on her passion and anger. I appreciate her frustration and share her desire for radical action. I think we can all agree that the Government’s announcement yesterday on scrapping NHS England demonstrates our willingness to be bold, take risks and do things differently.

Members raised several other matters. I will come back to them all with more detailed information on those issues, but I do not have the time to do so today. I will address the national cancer plan, however, which was raised a number of times. It is really important to fulfil our goal of transforming cancer care, and we will not just cherry-pick the most common cancers; we need a rising tide that will lift all ships. As a person who is living with an incurable cancer myself, I cannot overstate how deeply I feel the honour and responsibility of being asked to drive forward our work in creating the national cancer plan—it is my absolute honour. But while we take strides to fix cancer services, I am under no illusion that the Government or I hold all the answers, so my plea is for hon. Members to work with us and share their expertise. I ask them please to visit “Shaping the national cancer plan” on the Department’s website and to contribute evidence.

The Government are committed to making a real difference for patients with rare cancers. For those affected by this devastating disease, every discovery, every treatment and every moment matters. We will do all we can to facilitate the passage of this Bill here and in the other place.