Clinical Trials Regulations

Andrew Gwynne Excerpts

Thursday 12th December 2024 Written Statements

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

My noble friend the Under-Secretary of State for Health and Social Care, Baroness Merron, has made the following written statement:

I am pleased to announce that the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 have been laid before Parliament today. When approved by Parliament, this legislation will represent the most significant reform of UK clinical trials regulation in over 20 years, addressing the sector's need for a more efficient and adaptable regulatory framework, while safeguarding the wellbeing of trial participants. It will establish a proportionate, streamlined, flexible and effective clinical research environment, placing patients at the heart of the process and strengthening the UK’s position as a global leader for innovative clinical trials.

Clinical trials are essential for the safe development of medicinal products, allowing innovators to rigorously evaluate their products in healthy volunteers and patients. Through this, clinical trials provide a route for bringing pioneering new treatments directly to patients, serving as a crucial step in healthcare innovation. This legislation will play a vital role in transforming the environment for running clinical trials in the UK.

Modernising the regulatory framework will strengthen the UK’s standing as a prime destination for conducting groundbreaking, safe clinical trials. This supports the recommendations of the Lord O’Shaughnessy review, making the UK more attractive for commercial clinical trials and increasing opportunities for UK patients to have early access to innovative treatments that could improve or even save lives. These reforms will also help the NHS conduct trials more efficiently, fostering research that improves methods for preventing, diagnosing, and treating a wide range of conditions. Ultimately, this will expand patient access to new therapies and reinforce the NHS’s reputation as a world-leading platform for health and life sciences research.

The revised legislation aims to reduce unnecessary administrative burdens on trial sponsors while keeping participant safety at the forefront. By removing overly prescriptive elements, the legislation will introduce greater flexibility and risk-proportionality, reflecting the evolving nature of clinical trial design and the innovative treatments they investigate.

These reforms will:

Create a proportionate and flexible regulatory environment—the new legislation will empower researchers to take more risk appropriate approaches to trials, meaning the regulatory requirements will be more flexible to match the risk that a trial presents.

Cement the UK as a leading destination for international trials—the new legislation will introduce more streamlined and efficient application processes, making it easier to apply for trials in the UK but without compromising on safety standards. A combined regulatory and research ethics review will be brought into legislation and approval timelines will be internationally competitive.

Move away from a one-size-fits-all approach, to be responsive to innovation—the new legislation has been drafted to ensure it is as future-proof as possible and is responsive to different types of trials and innovative ways of carrying out trials. Guidance will be used for specific details, rather than granular and duplicative requirements in legislation.

Ensure patients and their safety are at the focus of all clinical trials and supported by greater transparency bring the benefits of clinical trials to everyone—the new legislation will ensure increased public transparency about trials, including a requirement for registration on a public database and sharing of trials results with participants.

The reforms were developed by the Medicines and Healthcare products Regulatory Agency and the Health Research Authority through a series of stakeholder workshops, seeking the views of a wide range of organisations and individuals from across the clinical research sector, including patient representatives. A public consultation took place in January to March 2022, to which over 2,000 responses were received, and the Government response was published in March 2023.

The regulations, along with the associated explanatory memorandum and de minimis assessment, an analysis of the impact of the reforms on business, will be published on gov.uk today.

[HCWS310]

Rare Autoimmune Rheumatic Diseases

Andrew Gwynne Excerpts

Tuesday 10th December 2024 Westminster Hall

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

It is a pleasure to serve under your chairmanship, Dr Huq. I thank the hon. Member for Strangford (Jim Shannon)—I want to call him an hon. Friend because he is a friend, but convention dictates that I must call him an hon. Member—and I welcome the fact that he cares so much about health-related issues. I now see him more than I see my wife, because he is always in debates about a whole range of health conditions, and he brings so much passion to those debates. Importantly, he highlights rare diseases. I thank him for the way he made his case this morning, and for speaking about Zoi’s experience. When we humanise these things, we make them all the more impactful.

I thank my hon. Friend the Member for Bootle (Peter Dowd) for his contributions, and I thank the Liberal Democrat spokesperson, the hon. Member for Mid Sussex (Alison Bennett), for humanising the issue through Carrie’s story; that is crucial. The shadow Minister, the hon. Member for Hinckley and Bosworth (Dr Evans), brings his professional experience to this debate, and that cannot be underestimated. I confess that I am not a medical professional, but in health debates it is important to listen to the expertise of those who work in the sector and on the frontline. I thank him genuinely for the way he has approached the debate. This is not a party political, knockabout debate; it is something on which we all want to see progress. The beauty of Westminster Hall is that we can leave the knockabout to the main Chamber, and in this room we can get into the detail of important subjects that are often overlooked. I pay tribute to those who are affected by rare disease, including rare autoimmune rheumatic diseases, and to their families.

The work of patient organisations such as RAIRDA is vital in raising awareness and campaigning to improve the lives of people who are living with rare diseases, and I thank those who dedicate their lives to this community. It is important to make the point that although rare diseases are individually rare, they are collectively common. One in 17 people will be affected by a rare condition over their lifetime. People living with rare diseases may face additional challenges in accessing health and social care. As the hon. Member for Mid Sussex said, this applies to a whole range of health services, including dentistry, and I hope that the Minister responsible for dentistry will pick that up. I will ensure that he receives her comments, because dentistry is often overlooked when it comes to people with rare conditions.

We are committed to improving the lives of people who are living with rare conditions. As the hon. Member for Strangford mentions, the UK rare diseases framework outlines four priorities to achieve this aim: helping patients to get a final diagnosis faster; increasing awareness of rare diseases among healthcare professionals; bettering co-ordination of care; and improving access to specialist care, treatments and drugs. Rare diseases are a priority for the Government. In England, we publish a rare diseases action plan annually, which details the specific steps we are taking to meet the shared priorities of the framework. Each action has an owner, desired outcomes and detail about how we will measure and report on progress. This Government are committed to delivering on the priorities framework, and we are working to publish the next England action plan in early 2025.

The UK rare diseases framework comes to an end in 2026, and I know that the rare disease community would like the policy to continue, to maintain the momentum and progress made over the lifetime of the previous framework. It is UK-wide and agreed across the devolved nations, and I am more than happy to discuss it further with colleagues in Wales and Scotland and, for the hon. Member for Strangford, with Mike Nesbitt, the Health Minister in Northern Ireland. I am the UK Health Minister with responsibility for engagement with the devolved Administrations when it comes to health and social care; indeed, we have a meeting with them and with the Secretary of State tomorrow to discuss a whole range of subjects. I am more than happy to discuss this issue further with colleagues to see if we can maintain four-nation co-ordination in this area. I believe that if we can do so, we should. I give the hon. Member for Strangford my commitment that I will take the matter up with the devolved Health Ministers to see if we can continue the four-nation approach.

In England, I am committed to working towards the four priorities of the framework, which were identified through the 2019 national conversation on rare diseases. Alongside the evaluation of England’s rare disease action plans commissioned through NIHR, the Department will undertake engagement next year to inform future policy decisions. The Government are committed to providing the best diagnosis and care for rare diseases, as set out in the UK rare diseases framework. Good diagnosis should be timely and accurate, and I know that people living with rare diseases often face journeys that are years long—diagnostic odysseys—before they receive an answer.

As the shadow Minister set out, many health professionals are involved in a patient’s journey, from those in specialist testing and genetic screening to GPs and primary care professionals. Raising awareness of rare conditions among those professionals is one way in which we can help to speed up diagnosis. I know that every experience of living with a rare disease is unique, and, with more than 7,000 identified rare diseases, we focus on addressing shared challenges across all rare diseases.

Although the increasing use of genetic testing is an groundbreaking tool in diagnosis, many conditions, including rare rheumatic autoimmune diseases, do not have an identified genetic component, so it is important that overall awareness, diagnostics and quality of care continue to serve all people living with rare conditions. NHS England is working to improve awareness of rare diseases among healthcare professionals, including those in primary care, through the NHS England genomics education programme, which includes non-genetic rare diseases. The GEP provides education and training to support the specialist and wider workforce to diagnose rare conditions early and to know how to deliver the best possible care for patients and families—the shadow Minister mentioned that. Working with partners such as Medics 4 Rare Diseases, the GEP has created genomic notes for clinicians, GeNotes, an innovative digital educational resource for healthcare professionals. The GEP works to provide information to GPs where and when they need it—for example, by presenting at primary care educational events, producing blended learning modules for GP trainees or ensuring regular reviews of the curriculum of the Royal College of General Practitioners.

The shadow Minister rightly mentioned research. I reassure him that the Department of Health and Social Care—this started on the previous Government’s watch, and we rightly are continuing the progress—supports research into rare diseases through the NIHR. The NIHR is the nation’s largest funder of health and care research, and it welcomes funding applications for research into any aspect of human health, including rare diseases. The usual practice of the NIHR and other research funders is not to ringfence funds for expenditure on particular topics. The “Rare Diseases Research Landscape Project Report” described investment of almost £630 million from MRC and NIHR programmes in rare disease research over five years. We are now working with the rare diseases community to further understand the gaps and the priorities, and to get them into those research pathways so that we can, we hope, fill the gaps.

As many rare diseases are chronic and affect multiple body systems, those living with rare disease face complex condition management, and interact with many specialists and providers of health and social care. That can include travelling across the country to access highly specialised care from experts. All of that can add up to a significant emotional and physical burden, and deepens existing inequalities. Co-ordination of care is essential to ensure that care is effectively managed, that the burden on patients and their carers is minimised and that healthcare professionals are working together to provide the best possible joined-up and high-quality care.

Last year, we hosted a workshop with RAIRDA to explore how best to support people living with “non-genetic” rare diseases. That highlighted the importance of specialised networks of care in delivering high-quality care at value for money. As we heard from the hon. Member for Strangford, networks, such as the Eastern Network for Rare Autoimmune Disease, are an example of best practice. I encourage integrated care boards to consider similar models across the whole country for types of rare diseases. I am more than happy to look closely at how we can seek to spread that best practice across the country, across different rare disease types and across ICBs, because patients with rare conditions deserve the same quality, safety and efficacy in medicines as other patients with more common conditions.

NICE, the MHRA and NHS England are working to understand and to address challenges preventing treatments for rare conditions from reaching patients who need them. I take on board precisely the points that the shadow Minister raises about the new drugs, how we ensure faster access and how we create the environment whereby clinical trials are more readily available in the United Kingdom. I want to assure Members that that is a central part not just of our health mission but of the Government’s economic mission, because we want the United Kingdom to be a base for investment in life sciences, in medtech and in access to clinical trials, so that our patients win as well as our economy. We have to ensure that safety is foremost in our deliberations. Safety is paramount, and we must ensure, in whatever regulatory regime that we have to encourage the life sciences, medtech and data industries into the UK, that safety is never compromised. I take on board fully the comments made by the shadow Minister.

NICE has also been working with RAIRDA to create a quality standard for rare diseases. That will find commonalities across the more than 7,000 identified rare diseases to develop standards that will drive quality improvement across multiple rare disease groups. Although the majority of rare diseases are genetic, others, such as rare autoimmune rheumatic diseases, do not yet have an identified genetic cause, as I said. A study by Genetic Alliance UK suggests that such conditions often have higher prevalence, impacting on a significant number of people, so it is important that both genetic and non-genetic conditions are considered.

Approximately 3.5 million people in the UK live with a rare condition, and addressing shared challenges across all conditions will be central to this Government’s approach. In addition, shared challenges across the health and social care system are often exacerbated for people living with rare diseases, such as access to mental health support—something else that the hon. Member for Mid Sussex mentioned. A central mission of this Government is to build a health and care system fit for the future.

The hon. Member for Strangford referred to our 10-year health plan. I reassure the House that that is intended to focus on the three shifts needed to deliver a modern NHS—not just fixing our NHS, but making it fit for the future, for the next 10, 20 or 30 years, putting it on a modernised footing as well as fixing the fundamentals. The three shifts are moving from hospital to community, from analogue to digital and from sickness to prevention. Those shifts offer opportunities to improve time to diagnosis and care for people living with rare diseases. Many highly specialised services for rare diseases must be delivered in hospitals to ensure the high standards of expert care that we want to see, but we can improve co-ordination of care to deliver better treatments closer to where people live, where possible. While many rare diseases are not preventable, early diagnosis can lead to interventions that improve health outcomes.

On the point made by the shadow Minister about community diagnostic centres, the Government’s commitment is to continue that programme. Indeed, I have seen the benefits of it myself—I got to open the new CDC at Crownpoint in Denton in my constituency in July. It is already having a game-changing impact on the local community, giving faster diagnosis and getting people into treatment more quickly, with better outcomes and better patient experiences for those who access the facilities.

The 10-year plan will ensure a better health service for everyone, regardless of condition or service area. On 21 October, we launched a national conversation on the future of the NHS, inviting views from across the country on how to deliver a health service fit for the future. Patients, staff and organisations can make themselves heard by logging on to the online portal, change.nhs.uk. I encourage hon. Members to do the same and to encourage their constituents to do likewise, if they have not done so already.

Unmet need remains, however, for people living with rare diseases, including rare autoimmune rheumatic conditions. I reaffirm that I am deeply committed, as is this Government, to working across the health and care system and with the rare disease community to address that need.

Finally, on workforce, the hon. Member for Strangford and other Members asked if the goal of the Government is to ensure that a patient gets the treatment, and that we get that treatment with the workforce we have. Getting that right workforce will be key. I reassure Members that the goal of the Government is to ensure that the patient, as they deserve, gets all the help that the NHS can offer in treatment, care and support.

The 10-year health plan will deliver those three big shifts on hospitals to community, analogue to digital, and sickness to prevention. To support delivery of the plan, the Secretary of State has confirmed that next summer we will refresh the NHS long-term workforce plan. That will help to ensure that the NHS has the right people in the right places with the right skills to deliver the care that patients need when they need it, not just today but in the future. The shifts we want to see in the delivery of healthcare will require us to rethink the kind of workforce we need in 10 years’ time.

[Dr Luke Evans]

I am grateful to the Minister for acknowledging the workforce, and for looking at the workforce plan. I was aware of the Health Secretary’s plan to revisit this, and the Minister talks about it being done next year. Does he have a timescale for how long the review will take? The danger, especially in healthcare, is that modernisation happens so quickly that, by the time we review something, it is already out of date and needs another review. This is always a chicken-and-egg situation. I would be grateful for a timescale.

[Andrew Gwynne]

We will refresh it next summer, and the Department is already beginning to think about whether this is what the shifts are intended to bring about, and whether these are the outcomes we want to see as a result of those shifts. If we are to have a neighbourhood health service that delivers much more in a community setting, how do we ensure we have the right skills and the right workforce to deliver that?

Particularly with the shift from analogue to digital, we will need a lot more tech-savvy clinicians, too. How do we build in some of the massive advances in artificial intelligence into medical devices and medical technology? We will be doing that concurrently with the 10-year plan to make sure that the workforce plan refresh is ready to go. This will allow us to embed the future, not just today’s practices, into the training and recruitment processes for the immediate future. The refresh will begin next summer, but it is a chicken-and-egg situation. We need to work out what the future of the NHS will look like, and then we have to ensure that we have the skills to meet that ambition—not just for today, but for the future.

In closing, I again thank my friend, the hon. Member for Strangford, for raising such an important matter, and I thank the rare diseases community for their continued and constructive engagement with the Government to help bring about meaningful change. I hope I have reassured the hon. Gentleman both on cross-UK working—and I take up his challenge to try to get colleagues across the devolved Administrations to agree to continue a UK-wide approach—and on my specific responsibility here in England. We will take forward the four areas identified in the UK plan. We will have a new plan for England, and we will seek to make the significant progress that I believe all Members of this House want to see happen.

I am more than happy to work collegiately with Members across the House, whose role is to scrutinise the Government, to hold our feet to the coals and to make sure we do what is in the plan at the best speed and pace for people living with these conditions. I also accept that I am not the sole fount of all wisdom in this area.

[Dr Luke Evans]

No!

[Andrew Gwynne]

I know the shadow Minister is surprised by that. Genuinely, whatever people bring to the table, whether it is personal experience, professional expertise or their constituents’ stories, we need to share that knowledge so that we can improve how we deliver the outcomes we want to see for people living with rare diseases. I stand willing and ready to work with hon. Members across the House, and indeed with organisations that champion this area, so we can get the best outcomes that people deserve.

Cumberlege Review: Pelvic Mesh

Andrew Gwynne Excerpts

Thursday 5th December 2024 Westminster Hall

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

It is a pleasure to serve under your chairmanship, Mr Stringer. I congratulate my hon. Friend the Member for Harlow (Chris Vince) on securing such an important debate on pelvic mesh and the independent medicines and medical devices safety review, also referred to as the Cumberlege review. We are all privileged to see the noble Lady Baroness Cumberlege in the Public Gallery. We thank her sincerely for the work that she has done over a number of years on women’s health, and on this issue in particular. I also thank my hon. Friend for the opportunity to contribute to this vital debate.

I am responding today on behalf of Baroness Merron, who leads on women’s health and patient safety in the Department of Health and Social Care. I will try to address as many as I can of the issues that right hon. and hon. Members have raised in this debate. If for any reason I do not get round to addressing something, I will ensure that Baroness Merron, as the Minister responsible, writes to Members.

This debate came about because of a meeting between my hon. Friend the Member for Harlow and one of his constituents, Debbie. As we have heard, Debbie described undergoing a failed procedure to remove vaginal mesh, which has caused her severe pain. She has remained in constant pain since the operation, and I express my deepest sympathy to her for her ongoing experience. It should never have happened.

My predecessor as a Minister, Nadine Dorries, placed on the record in 2020 the previous Government’s apology. We are a new Government, so I take this opportunity to make the same apology today on behalf of His Majesty’s Government elected on 4 July. This should not have happened, and I say to every single person it has happened to that we are sorry and we have a duty to put things right. That is what this Government will seek to do, and at pace.

This Government will build a system that listens, hears and acts with speed, compassion and proportionality. Complications from vaginal mesh can be devastating and have included severe and chronic pain, recurrent infections, reduced mobility, sexual difficulties and psychological impacts. It can be hard to imagine the avoidable suffering that many women have endured and the damage that has been inflicted on their lives. It is unacceptable that concerns raised by women were not listened to and that women were left to suffer alone. It is vital that we acknowledge those failures and ensure that the mistakes of the past are not repeated.

I assure the right hon. Member for Wetherby and Easingwold (Sir Alec Shelbrooke) that the 10-year health plan that the Government are consulting on will ensure a better health service for everyone, regardless of their condition or service area. A core part of the development of the 10-year plan, including its approach to women’s health, will be an extensive engagement exercise with the public, NHS staff and stakeholders.

We have heard about the nine specialist mesh centres that NHS England has established across England. The intention behind them is that every woman, in every region, who experiences mesh-related complications receives the appropriate support.

I hear the message of my hon. Friend the Member for Shipley (Anna Dixon) that more needs to be done on accessibility, outcomes and listening to women. I agree, and I will take that message back to Baroness Merron.

I share the concerns of the right hon. Member for Wetherby and Easingwold—I thank him for his support on this—about the battles and challenges that lie ahead to get the system right. The Government will consider how we build on existing provision in a sensitive way that meets the needs of the women. At the heart of all we do to try to put things right is addressing the needs of the women involved, and their families, who have been so dramatically affected by what went so tragically wrong.

Each mesh centre is led by a multidisciplinary team that comprises urology, gynaecology and colorectal consultants, in addition to nurses who specialise in a range of things that I am unable to pronounce, and in urology and incontinence, which I can pronounce. Patients also have access to other healthcare professionals, including psychologists, occupational therapists and pelvic floor specialists, to help with pain management.

I recognise the trauma that women have experienced and the vital need to exercise patient choice. That is especially true for women who are rightly concerned about being treated by a surgeon who previously operated on them. I hope that things have moved on since the answer that the right hon. Member for New Forest East (Sir Julian Lewis) received, but I will ensure that what Members have said, with the sincerity and the strength of feeling, is communicated back to Baroness Merron. I agree with the right hon. Gentleman that the process set out in that written ministerial answer is not acceptable. Yes, women have the right to choose treatment from another surgeon, but I actually agree with the shadow Minister that there should be an automatic assumption that their treatment should be done by somebody who did not operate on them previously, unless that woman does not mind. That is a stress and a trauma for many women, and we have to think about their rights.

I also recognise that there is a need to support GPs’ knowledge and understanding of pelvic mesh so that they can identify the symptoms of mesh complications and refer patients on to the appropriate services. I do not want any woman to be in the position of my hon. Friend the Member for Washington and Gateshead South (Mrs Hodgson), or any other woman who has had her body tampered with in the most inappropriate way, when the procedure was not even necessary, and has suffered lifelong complications as a result. We have to move on at pace.

Following Baroness Cumberlege’s recommendations in 2018, the national pause on mesh remains in place for the use of vaginally inserted mesh to treat prolapse and the use of retropubic suburethral mesh sling to treat stress urinary incontinence. That means that mesh can be used only in exceptional cases where clinicians are of the opinion that there is a clinical urgency and no suitable alternative exists. NHS England continues to monitor progress on the conditions associated with the national pause and will only make changes to it linked to clinical advice and following consultation with a wide range of stakeholders, including patients, professional bodies and NHS organisations.

The Cumberlege review made nine recommendations, and the then Government accepted seven. Of those seven, four have been delivered, including the appointment of Dr Henrietta Hughes as the first Patient Safety Commissioner in England, the establishment of nine specialist mesh centres across England and the establishment of a patient reference group. Through our ongoing work, the Government are committed to delivering on the remaining three recommendations.

On redress, I will mention briefly the recommendation set out in the Hughes report, which was published in February. I first thank the Patient Safety Commissioner, Dr Henrietta Hughes, for her commitment to improving patient safety. Although the Government are not yet in a position to comment on the recommendations, I assure Members that we are considering the wide range of work set out in the report. I agree with the hon. Member for Eastleigh (Liz Jarvis) that the previous Government were too slow on that. It is a priority for this Government. We are working at pace, and we remain focused on making meaningful progress. This is a complex area of work, involving several Departments, but we are committed to providing an update at the earliest opportunity. I have heard the desire for urgency today, and I hope that we can make the progress that Members want to see.

I am afraid that I have left my hon. Friend the Member for Harlow 30 seconds to sum up, but I hope we have made some progress.

Food and Drink Advertising Restrictions

Andrew Gwynne Excerpts

Tuesday 3rd December 2024 Written Statements

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

This Government are committed to creating the healthiest generation of children ever, and today we are taking another step towards achieving that goal.

Further to my statement on 12 September 2024, I wish to inform the House that today the Government will lay before Parliament the Advertising (Less Healthy Food Definitions and Exemptions) Regulations 2024 and an explanatory memorandum. This legislation enacts the provisions set out in the Health and Care Act 2022, which amended the Communications Act 2003, for a 9 pm watershed on the advertising of less healthy food or drink on television and a 24-hour restriction on paid-for advertising of these products online. Alongside laying the regulations, the Government are publishing a response to the technical consultation held between September and October 2024 on how the advertising restrictions apply to internet protocol television (IPTV) services, which deliver TV and advertising live over the internet. The consultation response confirms that IPTV services regulated by Ofcom will be subject to the broadcast restrictions (9 pm watershed), in the same way as other Ofcom-regulated TV and on-demand programme services, and we have clarified this in the final regulations. The Government are also publishing guidance for industry on the food or drink categories in scope of the advertising restrictions to support their preparation for implementation.

Following previous policy consultations and the Government’s response on 12 September 2024 to the consultation on the draft secondary legislation, the legislation and guidance published today provide businesses with further certainty in terms of the products, businesses and services in scope of the restrictions as well as practical guidance on their application, so that they can continue to prepare ahead of the restrictions coming into force on 1 October 2025. We will continue to engage with stakeholders during this period.

This delivers on our manifesto commitment to implement the junk food advertising restrictions without further delay, and in doing so we expect to remove 7.2 billion calories from UK children’s diets per year and reduce the number of children living with obesity by 20,000.

Obesity is the second biggest preventable cause of cancer and costs the UK health service more than £11 billion each year. By taking preventative action now, the Government will begin fixing the foundations of good health and protecting the next generation so that it can become the healthiest ever.

The Government’s response to the IPTV consultation and guidance on food or drink products in scope of the restrictions will be published on gov.uk shortly.

[HCWS278]

Health and Social Care

Andrew Gwynne Excerpts

Monday 2nd December 2024 Written Corrections

The following extract is from Second Reading of the Tobacco and Vapes Bill on 26 November 2024.

[Andrew Gwynne]

…We will still encourage adult smokers to switch to vaping through Swap to Stop in England, and I am delighted that localities have asked for over half a million starter kits so far. On advertising regulations, of course the consultation will take place after Royal Assent, but I hope that I can assure the hon. Member for Harrow East that we will take away his point about ensuring that the NHS can still advertise Swap to Stop under those regulations.

[Official Report, 26 November 2024; Vol. 757, c. 736.]

Written correction submitted by the Under-Secretary of State for Health and Social Care, the hon. Member for Gorton and Denton (Andrew Gwynne):

[Andrew Gwynne]

…We will still encourage adult smokers to switch to vaping through Swap to Stop in England, and I am delighted that localities have asked for over half a million starter kits so far. On vape regulations, of course the consultation will take place after Royal Assent, but I hope that I can assure the hon. Member for Harrow East that we will take away his point about ensuring that the NHS can still promote Swap to Stop under those regulations.

HIV Action Plan: Monitoring and Evaluation Framework Report

Andrew Gwynne Excerpts

Friday 29th November 2024 Written Statements

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

This Government are committed to ending new HIV transmissions within England by 2030. On 28 November, the Prime Minister made a significant down payment on this as he announced that emergency department opt-out testing for HIV will be extended to both extremely high and high prevalence areas during 2025-26, backed by £27 million of funding from the Department’s budgets, further confirming our determination.

I am pleased to update the House on the publication of the third annual report, “HIV Action Plan monitoring and evaluation framework 2024 report”. This report provides an annual overview to Parliament of the Government’s progress towards no new HIV transmissions within England by 2030, as committed to in the 2021 HIV action plan.

We are making progress towards our shared goals, and we should be encouraged by some of the highlights from the report.

HIV testing in sexual health services increased by 8% from 2022 showing greater rises in some key population groups, such as gay, bisexual and men who have sex with men where a 36% increase can be observed. This is coupled by a substantial progress to reduce new HIV diagnoses first made in England between 2019 and 2023, particularly among the same population group.

Overall, new HIV diagnoses first made in England fell by 12% from 2,801 in 2019 to 2,451 in 2022. However, this figure rose by 15% to 2,810 in 2023.

The blood borne virus opt-out testing in emergency department programme has been a great success and has helped us identify a significant proportion of new HIV diagnoses in 2023.

England continues to be one of the few countries in the world officially meeting the 95-95-95 targets when using the global measurement methods. However, in response to stakeholders’ suggestions, UKHSA adjusted the UNAIDS 95-95-95 targets, for the first time, so that they also account for people diagnosed but not in active HIV care and people for whom information on viral suppression was not reported. This new approach shows UNAIDS 90-90-90 goals were met in England in 2023 and partially met for the UNAIDS 95-95-95 goals, with 96% of all those living with HIV being diagnosed, 94% of those diagnosed receiving treatment, and 92% of those treated being virally suppressed and thus unable to pass on the virus.

Due to success in HIV treatment, over half of people living with HIV are over the age of 50.

However, there is more work to be done to achieve our shared ambitions.

Inequalities are widening in access to HIV prevention interventions, treatment and ongoing care, quality of life and stigma across most demographic characteristics, in particular, age, ethnicity, gender identity and exposure. For example, among men exposed through sex with men, HIV diagnoses fell by 35% amongst white men between 2019 and 2023, whilst in men from ethnic minority backgrounds, there was an increase of diagnoses from 26% in 2019 to 33% in 2023.

Similarly, there has been a significant increase in identifying need for and initiation of HIV pre-exposure prophylaxis (or PrEP): highest in white GBMSM and lowest in people from ethnic minority groups such as black African and black Caribbean.

As we reach the later stages in ending transmission, it is likely that identifying everyone living with the virus and narrowing inequalities will become more challenging. Our approach relies therefore on concerted efforts across the whole system.

The Department of Health and Social Care, the UK Health Security Agency, NHS England and a broad range of system partners in consultation with people living with HIV, their friends and families and the voluntary and community sector, are considering evidence from this report and working together to develop a new HIV action plan that will address these challenges. We aim to publish the plan in summer 2025.

I will keep Parliament updated on our progress and trust you will continue to support our shared goal of becoming the first country in the world to end HIV transmission.

[HCWS270]

World AIDS Day

Andrew Gwynne Excerpts

Wednesday 27th November 2024 Westminster Hall

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

It is a pleasure to serve under your chairmanship, Sir Mark. I am extremely honoured to have the opportunity to speak today at the first dedicated debate on HIV and AIDS in this Parliament. I am incredibly grateful to my hon. Friend the Member for Uxbridge and South Ruislip (Danny Beales) for securing the debate on a topic that is close not only to both of our hearts but to the heart of this Government.

We are a Government who are committed to ending new HIV transmissions in England by 2030. With World AIDS Day fast approaching on 1 December, the debate is a welcome opportunity to highlight the importance of our new HIV action plan, which we aim to publish in summer of next year. Achieving that goal demands collaboration and that is why dialogue and engagement with every part of the system will be crucial as we progress with the development of the new plan.

I am delighted to have the continuing support of colleagues from across the House, and like many speakers today I commend the engagement of fantastic charities and organisations such as the Terrence Higgins Trust, the National AIDS Trust and the Elton John AIDS Foundation, among many others. I also pay tribute to all Members who have contributed to the debate. I assure the hon. Member for Strangford (Jim Shannon) that, as the Minister responsible for public health in England, I will liaise closely with my counterparts in Northern Ireland, Scotland and Wales to ensure that we are all on track to end new cases of HIV in our respective jurisdictions.

My hon. Friend the Member for Gedling (Michael Payne) spoke powerfully, and the right hon. Member for Dumfriesshire, Clydesdale and Tweeddale (David Mundell) and my hon. Friend the Member for Exeter (Steve Race) both raised the issues of global inequality, stigma and the pervasive legislation that still exists in far too many parts of the world. I assure them and the whole House that this new Government will continue to be a major contributor to the Global Fund. Our obligations on the international stage are clear: we are not just about tackling HIV in this country, but around the globe. On human rights and anti-LGBTQ+ legislation, this Government and this country will always stand for equality, human rights and justice across the world, as well as at home.

My hon. Friend the Member for Clapham and Brixton Hill (Bell Ribeiro-Addy) spoke specifically about issues within black and minority ethnic communities. I would love to come and visit the new clinic she mentioned; consider it a date.

My hon. Friend the Member for Bournemouth East (Tom Hayes) made a lovely and loving contribution to the debate. On behalf of the British Government, I thank him for putting the name of John Eaddie on the record. John is no longer just a statistic; he is a human being who happened to die of AIDS. We pay tribute to John and to those who died after him, ahead of all the drugs, treatments and advances in technology that we now have. However, their death was not in vain, because we remember them and the sacrifices of their friends and families to support them in really difficult times so that we have a better world ahead of us today.

My hon. Friend the Member for Sherwood Forest (Michelle Welsh) and the hon. Member for North Shropshire (Helen Morgan), who spoke for the Liberal Democrats, also contributed to the debate. I assure the hon. Lady that this Government are committed to public health and prevention and although I cannot circumnavigate the Budget process, we will do all we can to restore the public health grant across this Parliament and into the future, because public health and prevention matter. They are a priority for us all.

On Monday, I had the pleasure of attending the launch of the voluntary and community sector report produced jointly by the Terrence Higgins Trust, the National AIDS Trust and the Elton John AIDS Foundation, where I offered my reflections on its valuable recommendations. I welcome the report and its recommendations, and I look forward to developing the HIV action plan alongside such a vital sector. We remain committed to hearing from those whose frontline expertise, grassroots connections and powerful voices will ensure that our plan is not only ambitious but grounded in the lived experiences of those it seeks to support.

Let me be clear: getting to zero new transmissions means smashing stigma. World AIDS Day is a stark reminder of how far we have come since the 1980s, but this year’s theme of tackling stigma starkly shows how far we have to go. It calls on all of us, not just as lawmakers but as members of our communities to reflect on the prejudice that people living with HIV have faced through not only a life-threatening illness but alienation, misinformation and discrimination. I have been thrilled to see the innovation and effectiveness of stigma-reduction strategies across the country. I am keen to build on that knowledge and work closely with the UK Health Security Agency as it continues to monitor stigma data through the “Positive Voices” survey report, to ensure that addressing stigma is a key priority for our new HIV action plan.

The experiences of the 1980s should remind all of us that stigma thrives in ignorance and silence. That is why we are determined to address it head-on, as part of honouring the legacy and work of so many others who went before. For the avoidance of doubt, we will not be satisfied until the number of transmissions reaches zero, yet there remain differences in the rate of diagnoses between demographics.

As the numbers move towards zero, we must work together to reach those communities that have not been captured thus far. That means including and empowering those voices, not essentialising them. It means cultural competence, innovation and collaboration. That is why we are hosting engagement sessions and roundtables in parallel with external stakeholders, including people with lived experience, the voluntary and community sector, professional bodies, local partners and others. We are working alongside UKHSA, NHS England and a broad range of system partners to inform the development of the new action plan, which will build on the progress made on the existing plan and guarantee that it is robust, inclusive and evidence-based.

Central to that effort is the importance of testing. That is a message we cannot repeat enough. I apologise to the shadow Minister, but I am going to repeat it: test, test, test. Testing is the gateway to prevention, treatment and ultimately ending new HIV transmission. We know that HIV opt-out testing works well. Over the past 27 months, more than 2 million HIV tests have been conducted, reaching those who do not typically engage with sexual health services.

Tomorrow, UKHSA will publish its opt-out testing report, providing us with the latest data. That will inform the next steps for the expansion of opt-out testing. We will also use that as a foundation to explore how our action plan can build on those successes—successes such as the national HIV testing week, yet we know that lower levels of testing persist among black African and heterosexual groups. We have seen that trend intersect with women, too. That requires tailoring our approach to reach those people living with undiagnosed HIV, who have been overlooked.

PrEP plays a vital role in the combination approach. Breakthroughs in science and medicine mean that, with the right treatment, people living with HIV can now lead long, healthy lives. The PrEP road map was published by the HIV action plan implementation steering group in February this year, identifying barriers to access for under-represented groups. That road map will guide our efforts to improve access, uptake and the use of PrEP among those most at risk of HIV.

In closing, I want to say that we are determined to reach zero HIV transmissions. On World AIDS day, let us honour those we have lost by recommitting ourselves to a future free from fear, misinformation and discrimination. The “Don’t die of ignorance” slogan is sadly as relevant today as it was on release. Together with science, compassion and unity we can achieve a future of zero new HIV transmissions, with stigma consigned to history.

[Sir Mark Hendrick (in the Chair)]

Order. In the 20 seconds we have left, I leave it to Mr Beales to say a few words.

Epigenetics

Andrew Gwynne Excerpts

Wednesday 27th November 2024 Written Statements

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

My noble Friend the Under-Secretary of State for Patient Safety, Women’s Health and Mental Health (Baroness Merron) has made the following written statement:

Today I am announcing the launch of a new research collaboration between the Government, UK Biobank and Oxford Nanopore Technologies. The new generation of nanopore-based molecular sensing technology created by this leading UK-headquartered, life science company will be used to conduct detailed genetic sequencing of 50,000 samples in the UK Biobank, the UK’s primary biomedical database.

This represents a significant expansion of Oxford Nanopore’s collaboration with UK Biobank which started with a 5,000-genome pilot. This new collaboration will create the world’s first comprehensive dataset of epigenetic modifications in the human genome and demonstrate the UK’s continued leadership in the field of genetics. Further exploration of epigenetics—the emerging study of how DNA and its expression is affected by modifications that do not change the underlying DNA sequence—could unlock a deeper understanding of the causes of diseases such as cancer and neurological conditions. This could pave the way for new diagnostic and targeted treatments, improving patient care and giving hope to the millions of people who live with conditions like these.

This expansion of the epigenetics programme is an early example of collaboration between Oxford Nanopore and HMG, building on the plans to form a strategic partnership announced on 5 November. I will provide further updates to the House on this collaboration as it develops.

[HCWS257]

Tobacco and Vapes Bill

Andrew Gwynne Excerpts

2nd reading
Tuesday 26th November 2024 Commons Chamber

[Jim Allister (North Antrim) (TUV)]

I will vote for this Bill. I admit that I am sceptical about the enforceability of the age escalator, but fundamentally the legislation addresses a huge problem in our society. There can be no doubt that smoking is a killer, so it is our responsibility to seek to diminish the death toll. Vaping is a totally unregulated sector, and I fear that it is a gateway to smoking for many young people. Therefore, it is right that it, too, comes within the ambit of the Bill.

The Secretary of State said this afternoon that this is a “four-nations Bill”. I welcome that, and I trust that it is right. That is the point I want to test in my contribution, and I will seek reassurance from the Minister about it. The reason I want to test it is that Northern Ireland, and Northern Ireland alone, is still subject to the EU’s tobacco directive. We are subject to the EU’s tobacco directive because it is one of the 289 EU laws listed in annex 2 of the protocol—or the Windsor framework, as it is now called—that remain in force in a part of this United Kingdom. Article 24 of the tobacco directive says:

“Member States may not…prohibit or restrict the placing on the market of tobacco or related products”.

Does this Bill, by its necessary steps, restrict the placing on the market of tobacco? If it does, it will fall foul of the tobacco directive and will therefore be unenforceable in Northern Ireland, because of our ridiculous subjection to foreign laws that we do not make and cannot change.

We have an illustration of what might happen, because in 2022 Denmark sought to introduce almost identical legislation. It had to withdraw it, and in withdrawing it, the Health Minister told the Danish Parliament on 6 April 2022:

“The ministry…therefore considers that a ban on the sale of tobacco and nicotine products to people born in 2010 or later would require an amendment to the European Tobacco Products Directive”.

On that basis, they withdrew it. Earlier this year, the Irish Republic was minded to introduce legislation like this, but it did not proceed for the same reason.

If we are in a situation where a part of this United Kingdom quite absurdly cannot be governed by laws that this Parliament wishes to make, we are in a very sad situation indeed. It is my fear that, like in Denmark, the imprimatur would not be forthcoming from the tobacco directive and we could therefore have a situation where laws that we want to make and apply throughout the United Kingdom cannot be applied because of our subservience to foreign jurisdiction. If that is so, it will be an appalling situation. The House will have an opportunity to do something about this when my private Member’s Bill comes before it on 6 December, and I trust that Members will take that opportunity to liberate Northern Ireland from the bind of foreign jurisdiction and foreign law.

There are vested interests who will try to challenge the Bill’s applicability in Northern Ireland because of the tobacco directive, and I am fearful of the line that the courts might take, because we have had some examples. This House passed—for better or for worse—the Northern Ireland Troubles (Legacy and Reconciliation) Act 2023. It also passed the Safety of Rwanda (Asylum and Immigration) Act 2024. I am not commenting on their merits; I am making it clear that when they went to the High Court in Belfast, both were declared inoperable in Northern Ireland. Why? Because of the supremacy of EU law.

If that were to happen with this Bill, it would be an absolute scandal. We would not be able to afford the people of Northern Ireland the same health protections that the Bill will afford to everyone else in the United Kingdom. And why not? Because we are subject to a foreign jurisdiction. It is the lifting of that jurisdiction that will bring us liberty to be governed as this House would wish us to be governed, and I trust that the Minister will be able to assure us that those fears are unfounded, that the Danes were wrong to withdraw their Act, and that our courts will—

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

I am grateful to the hon. and learned Gentleman for giving way. I fully understand his concern. That is why this Government need to give credit to the previous Government, who worked so hard to make this a four-nation approach. I want to give him and the House the assurance that it is the responsibility of the UK Government to ensure the compatibility of the Bill with the Windsor framework. The Government have taken into account all domestic and international obligations in bringing forward this Bill today.

[Jim Allister]

It gives me no assurance if the Government’s commitment is to ensure compliance with the Windsor framework, because it is the Windsor framework that imposes EU law on Northern Ireland. Because the tobacco directive is one of the laws listed in annex 2 that continue to apply to Northern Ireland, it could trump this Bill. There is no point in the Government saying to this House, or to my constituents, that they will abide by the Windsor framework, because the Windsor framework binds us to EU law. It is only by setting it aside that we can have liberty.

[Andrew Gwynne]

I am sorry to detain the House, but I make it clear that this is a United Kingdom law. It covers all four nations of the United Kingdom, and we are assured that it complies with the requirements of the Windsor framework. This law will stand.

[Jim Allister]

The previous Government told this House—and Government lawyers probably said the same—that the Rwanda Act would apply to Northern Ireland and that the legacy Act was unchallengeable, yet it turned out that both fell under the supremacy of EU law. On the face of it, the tobacco directive suppresses this Bill and still has legal force in Northern Ireland. If that is how it turns out, I would like to hear a commitment from the Minister that the Government will override any suppression of this law in Northern Ireland and stand up for UK sovereignty in my part of the United Kingdom.

--- Later in debate ---

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

It is a pleasure to close this debate on behalf of the Government. I commend my hon. Friends the Members for City of Durham (Mary Kelly Foy), for Newcastle upon Tyne East and Wallsend (Mary Glindon), for Chatham and Aylesford (Tristan Osborne), for Suffolk Coastal (Jenny Riddell-Carpenter), for Worthing West (Dr Cooper), for Southampton Itchen (Darren Paffey), for Mid Cheshire (Andrew Cooper), for Cardiff West (Mr Barros-Curtis), for Dartford (Jim Dickson), for Bolton North East (Kirith Entwistle), for Hartlepool (Mr Brash) and for Bolton West (Phil Brickell) and, on the Opposition Benches, the hon. Members for North Dorset (Simon Hoare), for Harrow East (Bob Blackman), for Lewes (James MacCleary), for Aberdeenshire North and Moray East (Seamus Logan), for Bath (Wera Hobhouse) and for South Antrim (Robin Swann), the hon. and learned Member for North Antrim (Jim Allister) and the hon. Member for Newbury (Mr Dillon), for a series of outstanding contributions this afternoon. Many of us on the Labour Benches remember the last Labour Government’s proud history of public health measures—indeed, some of us were in this place at the time. From the indoor smoking ban to putting an end to cigarette advertising, we took the bold action to drive down smoking prevalence, and the country is still feeling the benefits of those policies today. However, after 14 years of public health neglect, we have seen much of our hard work squandered. Health inequalities have grown worse, and life expectancy is stalling. Most appallingly, life expectancy is going into reverse in some communities.

[Afzal Khan (Manchester Rusholme) (Lab)]

I welcome this Bill. Some 6,000 children in Greater Manchester take up smoking each year, allowing tobacco and vape companies to profit from increasing health inequalities. If we eradicate smoking, Greater Manchester’s economy will gain over £2.5 billion each year, funds that could be allocated to our health and social care sector. Does the Minister agree that if we follow the recommendations of the smoking review by Professor Javed Khan OBE, who did an excellent job on that review, we have the unique opportunity to both save lives and reduce poverty, creating a healthier and more equal society?

[Andrew Gwynne]

I thank my hon. Friend for that contribution, not least because it allows me to place on record this Government’s thanks to Javed Khan for the work he did in his review of smoking. My hon. Friend has hit the nail on the head, because in the parts of Greater Manchester that he and I represent, health inequalities are stark and visible. We are going to turn them around. Our health mission pledged to tackle the social inequalities that influence health, and to ensure that children have the very best start possible, in which they are given the building blocks for a healthy life. That will be an immense challenge, but every member of this Government is up for the battle.

Colleagues have made a number of points, and I will try to answer as many as I can in the time we have left. First, I pay tribute to the hon. Member for Harrow East for the work he has done on this issue over a number of years. I assure him that all tobacco products are covered by this Bill, including the chewing tobacco product that he referred to. My hon. Friend the Member for City of Durham, who has also been a passionate spokesperson for tackling smoking harm, is absolutely right to raise the issue of article 5.3. The new Labour Government take very seriously their obligations as a party to the World Health Organisation’s framework convention on tobacco control, and we remain fully committed to that convention, including the important commitment, under article 5.3, to protecting public health policies on tobacco control from

“commercial and other vested interests of the tobacco industry”.

The shadow Secretary of State, the right hon. Member for Melton and Syston (Edward Argar), referred to the powers to bring in smokefree places. We will consult on extending smokefree places to include areas outside schools, children’s playgrounds and hospitals in England. We believe that strikes the right balance between protecting the most vulnerable and recognising the pressures facing the hospitality sector. I want to make the shadow Secretary of State aware, though, that the Bill was designed in full consultation with, and to meet the needs of, the devolved Governments across the whole of the United Kingdom. It is a UK Bill, with powers that meet the requirements of each of the component parts of our country, and I reiterate that as far as England is concerned, this Government will seek to consult on schools, children’s playgrounds and hospitals only.

A number of Members, including the hon. Member for Harrow East, raised the topic of stop smoking services. We are putting an extra £70 million into local stop smoking services, which could help with up to 200,000 successful quits a year. We are still rolling out a smokefree pregnancy incentive scheme, which will support pregnant women in quitting and ensure that more babies do not suffer a hit to their life chances before they are even born.

[Jamie Stone (Caithness, Sutherland and Easter Ross) (LD)]

I am very sorry that I was not in the Chamber for the beginning of the debate. I have very strong views on this matter, because my father died of cancer—I quit 20 years ago, thank God. It occurs to me that we have heard from other people who have quit, and that we who have quit could be mobilised to help others quit. Why do the Government not use us? We could do a lot of good and provide a lot of help.

[Andrew Gwynne]

I think the hon. Gentleman has just talked himself into a job. He is absolutely right that the best people to advocate for stopping smoking are former smokers.

We will still encourage adult smokers to switch to vaping through Swap to Stop in England, and I am delighted that localities have asked for over half a million starter kits so far. On advertising regulations, of course the consultation will take place after Royal Assent, but I hope that I can assure the hon. Member for Harrow East that we will take away his point about ensuring that the NHS can still advertise Swap to Stop under those regulations. On a tobacco industry levy, fiscal matters are for the Treasury, but I am sure that his views and those of others have been communicated to Treasury Ministers.

The hon. Member for Lewes mentioned the rise of the black market. This is a line that has been parroted by the tobacco industry for years, so we need to spell out the facts. Whenever Governments of any guise have introduced targeted tobacco control measures, the black market actually has not prospered. Consumption of illegal tobacco has gone from 15 billion cigarettes nearly 25 years ago to just one 10th of that amount last year, and when the last Labour Government raised the age of sale from 16 to 18, the number of illicit cigarettes fell by a quarter. However, this requires better enforcement, and we will use every second of the generously long buffer period to support businesses in preparing for and implementing the changes, including through information campaigns. We are providing £10 million to trading standards to increase their capacity and capabilities next year, and there is £100 million for Border Force and His Majesty’s Revenue and Customs over the next five years to tackle illicit and under-age sales. The Bill also allows trading standards to issue on-the-spot fines of £200, and to reinvest the proceeds of those fines, and indeed the licensing regime, back into further enforcement.

[Bob Blackman]

Will the Minister consider ensuring that the fines are raised by at least inflation each year? Fines could be increased on a scale, to make sure that they keep progress with changes.

[Andrew Gwynne]

We have already doubled the fine proposed in the previous Government’s Bill, which is a step. I listened very carefully to the hon. Gentleman’s argument, and he might wish to pursue it in Committee, should he be fortunate enough to be a Committee member. I look forward to the debates we might have.

A number of questions about the licensing regime were posed by the shadow Secretary of State, as well as by the hon. Member for North Shropshire (Helen Morgan), the hon. Member for North Dorset (Simon Hoare) and others. I reassure the House that across the sector, there is broad consensus among retailers about a licensing scheme; more than four fifths of them have expressed their support. Unlike alcohol, there is no licensing requirement for tobacco. A lot of people outside this House would find that hard to understand. They assume that convenience stores, supermarkets and other places that sell alcohol are licensed in a similar way to sell tobacco products, but that is not the case. We will bring in a licensing scheme, because we know that will have a huge public health impact, as other licensing regimes do.

[Tristan Osborne]

When I was on a council, I had a portfolio managing licensing. Councils already manage significant licensing functions, so it would be very convenient to simply add this function to those. That would not necessarily be a significant bureaucratic hurdle, as has been said.

[Andrew Gwynne]

Local government will take the lead on this matter, and we will consult widely on how we bring forward the licensing regime, and on how we implement it through secondary legislation, following that consultation. An impact assessment will be prepared before the secondary legislation is introduced, but I want to work with local government across England—I am sure that ministerial counterparts in other parts of the United Kingdom seeking to bring in a licensing regime will do the same—to ensure that we get this right for local government. That includes ensuring that the cost of running a licensing regime is met by the regime itself.

[Mr Brash]

We have mentioned the fact that local government is responsible for public health. I have had our director of public health email me just today to say how supportive they are of this Bill. Local government wants this opportunity to try to improve the health of local people. The fears that local government would be under pressure are simply wrong, are they not?

[Andrew Gwynne]

My hon. Friend is absolutely right. From the engagement that I have had with members across all parties in local government—elected members, officers and directors of public health—I know that they want these measures. They are up for introducing them, and for helping us to get them right.

The hon. Member for North Shropshire raised the issue of ID checks, as did a number of others. I gently say to those who expressed a degree of scepticism that most retailers already follow recommended practice and regularly ask customers for ID. We are stopping people from ever starting smoking, and 83% of smokers start before the age of 20. That means that someone who has never previously smoked is highly unlikely to want to take up smoking later in life. Our published modelling shows that smoking rates in England for 14 to 30-year-olds could be close to 0% as early as 2050 with the measures in this Bill.

[Amanda Martin (Portsmouth North) (Lab)]

As a former teacher, I hope that the Government are working across Departments. Will we work with the Department for Education to ensure that these conversations are had in our schools, right from the beginning, at primary level, and all the way through?

[Andrew Gwynne]

That is absolutely crucial. With this legislation, we have to make sure that we do not take our foot off the pedal when it comes to education and informing the next generation of children of the harms of smoking and vaping through our public health initiative.

[Johanna Baxter (Paisley and Renfrewshire South) (Lab)]

My constituents in Paisley and Renfrewshire South need a health service that moves from sickness to prevention, so can my hon. Friend confirm that this UK-wide Bill will impact my constituents? Has he had discussions with the Scottish Government about ensuring its implementation north of the border?

[Andrew Gwynne]

That is an important point, and it allows me to place on record my thanks to the Health Ministers in Scotland, Wales and Northern Ireland for how they have approached our desire to bring all parts of the United Kingdom together to make a smokefree United Kingdom, not just a smokefree England, through this legislation. I hope that I can reassure my hon. Friend that I have had incredibly fruitful conversations with the Health Minister in the SNP Scottish Government. She is as wedded and committed to this Bill and its measures as we are in this House today. I am reassured that across the whole United Kingdom, we will be walking in step to ensure that the next generation of children never takes up smoking.

[Several hon. Members rose—]

[Andrew Gwynne]

I will not give way now, as I have to end my speech. I know that you are keeping a careful eye on the clock, Madam Deputy Speaker.

If I had had more time, I would have talked about the huge public health benefits of the Bill that will do so much to prevent death, dementia and disability in old age. I could have gone into further detail about the economic benefits of the Bill, such as getting people back into work and saving untold sums of money for our NHS, but, from my perspective, the single most important thing that the Bill will do is tackle those stark inequalities across our country, because this fight is personal to me.

I have seen the harmful effects of tobacco on the people around me my entire life. As a schoolboy, I was educated about the harms of smoking, but it did nothing to stop a number of my peers from getting addicted to cigarettes. As an MP, I have seen at first hand how tobacco has devastated deprived communities across our country, not least in Greater Manchester. As the Minister for public health, I am determined to end the cycle of poverty and ill health, the blight of addition, disease and despair caused by smoking. No longer will it sap the strength of our cities—Stoke, Sunderland, Salford and so many others. This is the will of His Majesty’s Government, this is the promise of the Bill, and I urge colleagues across the House to vote with us to protect their constituents and do the right thing.

Question put, That the Bill be now read a Second time.

Draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024

Andrew Gwynne Excerpts

Tuesday 26th November 2024 General Committees

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

I beg to move,

That the Committee has considered the draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024.

It is a pleasure to serve under your chairmanship, Mr Efford. I will begin by setting out the policy context for the regulations.

The 2020 independent medicines and medical devices safety review, led by Baroness Cumberlege, highlighted the consequences of inadequate post-market regulations for patients, especially women, who received pelvic mesh implants. The review found that the system often failed to listen to patients’ concerns and acted too slowly when issues were identified. Those women have suffered horrendously as a result. The review called for substantial changes to the Medicines and Healthcare products Regulatory Agency, the MHRA, to ensure patient safety, including improved regulation of medical devices to enhance the collection of adverse incident data to reduce patient safety risks and prevent a recurrence of harm.

This statutory instrument will deliver improved safety for patients. It will introduce clearer and more robust requirements on medical device post-market surveillance—PMS—so that manufacturers are required to collect and evaluate the safety and performance of medical devices in a thorough and consistent manner, once they are in real-world use.

What will this mean for patients in the UK? This instrument represents the first step in a series of amendments to reform the Medical Devices Regulations 2002. These changes are designed to enhance the safety of medical devices, to ensure availability and to support innovation.

This instrument will create a strong foundation for this medtech regulatory reform and deliver patient benefits in three key areas—first, by improving patient safety. This instrument will not only enable the MHRA, but the whole health system to better protect patients by more closely monitoring the safety and performance of medical devices. This includes medical devices within the NHS and in our local communities, thereby supporting the Government’s mission to shift focus from hospital to community. This will result in more rapid identification, investigation and resolution of safety issues, allowing the NHS to focus its resources more effectively. While doing so, these regulations will also strengthen the patient voice by requiring manufacturers to undertake patient and public engagement where appropriate during their post-market surveillance.

Secondly, this statutory instrument will provide stronger assurance that devices supplied to the market are safe and effective, supporting both the continuation of supply, and improved access for the NHS and patients to potentially transformative technologies. With stronger assurance of safety and efficacy, we are able to implement new routes to market. For example, this instrument will help support the introduction of an international reliance framework, taking into account, where it is safe to do so, decisions made by comparable regulators. We intend to lay that draft legislation in 2025 as part of future medical devices regulatory reform.

Finally, this instrument will support innovation and economic growth by providing regulatory certainty for manufacturers considering placing their medical devices on our market. The collection of real-world data can result in more user-friendly and more effective innovations by highlighting opportunities for improvement, ultimately achieving better outcomes for patients.

I will now take a moment to summarise the key provisions of this instrument. Once in force, this statutory instrument will ensure that any medical device placed on the Great Britain market is subject to rigorous post-market scrutiny. This will enhance patient safety across the board, thereby promoting a consistent approach to PMS throughout the UK, where of course Northern Ireland has its own arrangements. This statutory instrument will set out in greater detail what must be included as part of a PMS system and a PMS plan. Manufacturers will need to ensure that their PMS system includes analysis of relevant data throughout the medical device's lifetime.

This comprehensive approach allows for a more accurate assessment of device performance, ultimately leading to faster identification and resolution of safety issues. This statutory instrument will provide greater detail on when and how to report serious incidents. The timelines for notifying the MHRA will be standardised throughout the UK, benefiting manufacturers that supply medical devices to both Northern Ireland and Great Britain and ensuring that safety issues are identified and investigated promptly.

The introduction of new requirements to share summary reports at regular intervals means that medical devices will be continually monitored to ensure their performance, with higher-risk devices facing even more scrutiny. These measures encourage manufacturers to monitor both serious and non-serious incidents over time, which will aid recognition of adverse safety trends and signals, supporting the containment of potential safety issues before they escalate.

I commend these measures to the Committee.

--- Later in debate ---

[Andrew Gwynne]

I thank the hon. Lady for her valuable contribution. These regulations introduce clearer, more robust requirements for post-market surveillance of medical devices, to improve patient safety and to signal a crucial shift in the way in which we manage medical devices in Great Britain.

The hon. Lady raised some important points. First, on the MHRA and whether it is appropriately resourced to cope with the likely increase in incident reporting as a result of this regulatory change, let me reassure her that the measures introduced in this instrument should not have a significant impact on MHRA capacity. Its systems and processes to provide regulatory oversight for vigilance reporting are already in place. The measures within this statutory instrument are expected to increase the volume of safety data reported to the MHRA. However, the accompanying improvements to data quality will support automation and reduce burdens associated with data analysis. To ensure that the MHRA’s systems for vigilance reporting are fully equipped to handle the new reporting requirements for manufacturers, we will verify system-readiness through comprehensive testing and validation ahead of the date of application of these regulations.

As the regulator for the whole United Kingdom, the MHRA is committed to protecting patient safety while enabling a regulatory environment in which the life sciences sector is able to innovate and to launch new medical products in the interests of public health across the UK. Contrary to the hon. Lady’s assertion that the regulatory burden will be increased and will therefore squash innovation, the opposite is the intention of this Government. The intention is to ensure that there is a clear regulatory framework throughout the United Kingdom—without having the disparities that we have at the moment—and to ensure that better, smarter use of the data will be available. The closer scrutiny of the efficacy of these medical devices will encourage innovation in medtech and in life sciences.

[Dr Caroline Johnson]

The Minister is saying that more regulation will encourage innovation. I am not sure I agree with that premise, but does he accept that these new regulations will lead to a higher regulatory burden on people wanting to set up medtech companies in the UK than in the EU or elsewhere?

[Andrew Gwynne]

We could get into a theological debate about the benefits or otherwise of regulations, but this statutory instrument will provide certainty and clarity across all four nations of the United Kingdom. It will provide a known framework for medtech and life science companies operating, or wishing to operate, in the UK. I see this as a good piece of secondary legislation to bring about the certainty that we want to give companies wishing to operate, or which are operating, in the United Kingdom, and to set up a common framework across our four nations. I see that as good. Regulatory divergence with another part of the United Kingdom is not, in my mind, good for business—particularly where a company wants to operate on both sides of the Irish sea.

On patient confidentiality and the cost estimates for the NHS, I hope the hon. Lady will forgive my having to write to the Committee on that point because the tablets of stone have not yet reached me from Mount Sinai.

On the hon. Lady’s question on innovation being reversed and whether people have long enough to prepare, we believe that the measures in the statutory instrument do give people long enough to prepare—not least because many of those companies are already operating in the parts of the United Kingdom that the instrument will bring our regulation in line with. Therefore the extra capacity that is needed in the system will not be to the detriment of the measures in this statutory instrument.

[Dr Johnson]

Parts of the UK are working to EU regulations, but does the Minister recognise that the statutory instrument he is bringing forward will introduce into the whole of the UK market, regulations that are not currently present in either the UK or EU markets?

[Andrew Gwynne]

I recognise that we are not only bringing Great Britain in line with Northern Ireland but adding other patient safety measures. If the hon. Lady is saying—I hope she is not—that the result of the Cumberlege review is that we do nothing in this area to improve the issues highlighted by it, she is within her powers to oppose these measures. However, we think not only that ensuring regulatory consistency throughout the United Kingdom is the right thing to do, but that this statutory instrument gives us the opportunity to start to put right some of the shocking, appalling things that we know have happened, as highlighted by the Cumberlege review. That is what these measures seek to do.

This Government are committed to the delivery of a framework for medical device regulation that prioritises patient safety—that is the crucial thing that we are seeking to do—and that gives patients access to the medical devices they need, and ensures that the United Kingdom remains an attractive market for medical technology innovators. We have an obligation to patients and the public to maintain the highest standards of safety and efficacy for the medical devices they rely on. These regulations are an important first step to deliver this framework, and they place patient safety at the forefront. They will enable not only the MHRA but the whole health system to better protect patients.

I am grateful to the hon. Lady for her contribution, and to Members across the Committee for considering these regulations today. I hope they will join me in supporting these regulations, so that we have consistency across the UK and put patient safety at the heart of medtech and life sciences.

Question put and agreed to.