World ME Day

Sajid Javid Excerpts

Wednesday 1st May 2024 Westminster Hall

[Sir Sajid Javid (Bromsgrove) (Con)]

I beg to move,

That this House has considered World ME Day.

It is a pleasure to serve under your chairmanship, Dame Siobhain, and I am extremely grateful to colleagues from across the House for their attendance.

There is no single universal experience of myalgic encephalomyelitis, otherwise known as ME. For those living with the condition, the distressing and familiar pattern can be all too clear: initial signs of fatigue, a drastic change in physical ability and activity, and the loss of mental focus and confidence.

The condition can begin after a battle with a viral infection, but for others the start of symptoms can simply seem unexplainable. Answers and hope are sought by visiting medical professionals, but too often ME patients are misdiagnosed or, at worst, dismissed entirely. Parents and carers who simply try their best can be chastised, as a once healthy person—a loved one—is slowly taken away by this cruel condition.

As a country, we have made tremendous progress in combatting so many diseases and illnesses. There has been a welcome step change in medical advancement and attitudes, but people with ME have not seen that progress—in fact, I would argue that they have been left behind. This debate provides an opportunity to share the experiences of people living with the condition ahead of World ME Day on 12 May and for us to consider what more can be done to improve experiences and outcomes for people across the United Kingdom. Today we are joined in person and online by many people who live with this condition, and I thank them for their continued strength.

When I was appointed Secretary of State for Health and Social Care, we were in the middle of fighting the pandemic. Of course, priorities and resources were naturally stretched, but the emergence of long covid saw renewed attention brought to ME. For me, the fight against that illness was not just an important policy area but simply very personal. My cousin, who is here today, has an amazing daughter who bravely battles this condition. Until the age of 13, she was a happy, healthy teenager. She was academically gifted and a talented netball player. Seven years later, today, her life has completely changed.

As Secretary of State, I set out my vision for a new approach to ME chronic fatigue syndrome in May 2022. I co-chaired a roundtable with the chief scientific adviser, Professor Lucy Chappell, to bring together experts, including people with lived experience, to discuss what needs to happen next. I also announced the Government’s intention to develop a cross-Government delivery plan for England. Two years later, although Ministers have understandably changed, I hope the determination that I had to tackle this condition remains in Government.

I was pleased to see the publication of an interim delivery plan by the Government in August last year. Supporting people with ME should be a cross-Government initiative. Although the work is rightly led by the Department of Health and Social Care, I was pleased to see that the plan was jointly published with the Department for Education and the Department for Work and Pensions.

[Dame Margaret Hodge (Barking) (Lab)]

I am very pleased to serve under your chairship, Dame Siobhain. I want to raise the issue of the involvement of multiple Departments, and it relates to my constituent Sienna Wemyss, who is 16 years old. Sienna was diagnosed in 2022, but she still has not got an education, care and health plan. She got a place at our local Barking and Dagenham College, but when she arrived there, despite her mother having spoken to the teachers, she was sent home because she could not attend. She finds it difficult even to comb her hair, so she is at home and has lost out on her education.

Does the right hon. Member agree that it is really important that not only health but education plays its role? While I am on my feet, I should say that Sienna has to travel as there are no local health facilities to respond to her needs and to care for her. She has to travel into University College Hospital—miles from my constituents in Barking. Does the right hon. Member further agree that there should be local healthcare facilities to respond to the needs of people with this condition?

[Sir Sajid Javid]

I thank the right hon. Member for her intervention, and I agree with her on both points. She first emphasises the importance of the Government’s final plan being a proper cross-Government plan; I hope the Minister will speak to the cross-Government nature of the work that he is leading on their behalf. I also agree with her point about local health support. That must also be addressed and covered in the final plan that is published. I have heard very similar stories from constituents and others, and I completely agree with what she said. I thank her again for that intervention.

When I committed the Government to developing a cross-Government delivery plan, I stated in a written statement to this House:

“officials will work with stakeholders ahead of publishing the delivery plan later this year.”

Despite the commitment that the delivery plan would be published by the end of 2022, it was not until August 2023 that an interim plan was published. In the ministerial foreword to that interim delivery plan, the Minister’s immediate predecessor—my hon. Friend the Member for Faversham and Mid Kent (Helen Whately)—stated:

“The final delivery plan will be published later this year”.

That was the end of last year. We are now in May 2024, approaching exactly two years since I made the initial commitment.

I am also now hearing disturbing reports that, despite two years of waiting, the final delivery plan may not be published until the end of this year. Everyone knows that the Prime Minister has committed the country to a general election by the end of this year. We also know that when that general election is called, there will be no Government publication of any sort, which means there is absolutely no time to waste. I ask the Minister, when he responds, to give a specific commitment to the House that the final delivery plan will be published before the summer recess—or at the very latest, just after.

[Danny Kruger (Devizes) (Con)]

I pay tribute to my right hon. Friend for the leadership that he has shown, and continues to show, on this issue. I have been contacted by Phoebe van Dyke, a young woman living in my constituency who is struggling with ME. She is concerned about the extent of the skills of the general medical profession: too many of the doctors she encounters do not understand enough about the condition. Can my right hon. Friend assure me that the delivery plan that he wants the Government to bring forward will ensure that there is much better training across the range of medical professionals, so that they have the skills to understand the condition?

[Sir Sajid Javid]

I assure my hon. Friend that that is definitely what I want to see in the plan; perhaps more important now, however, is to hear that commitment from the Minister. It is touched on in the interim plan, but we all want to see that issue, among the others, addressed in that final cross-Government plan.

The interim delivery plan set out some of the current challenges that we must address to improve outcomes and experiences for individuals with ME. We must ensure that the final delivery plan focuses at least on two key areas: outcomes and experiences. However, making progress in these areas also requires us to address more fundamental problems. For example, there is a huge cultural problem, when it comes to ME, with a lack of medical understanding and awareness. There is a critical lack of data and research, and there is still no existing cure or even treatments. It is estimated—this number is often cited; I use it myself—that about 250,000 people are living with ME in the UK, but even that figure is 10 years old, highlighting the lack of data and research in this field. Without a clear dataset and understanding, tackling the issue of course becomes an even bigger uphill battle.

That is why there are research projects such as DecodeME. They are vital because they help to increase understanding and they serve as a critical platform for future work.

[Helen Morgan (North Shropshire) (LD)]

Does the right hon. Gentleman agree with me that another issue faced by constituents is that the National Institute for Health and Care Excellence guidelines that were introduced are not being used by every single trust in the country? I think that only 28% of NHS trusts are using the NICE guidelines. Does he agree that consistency of treatment and approach would be an important step in ensuring that people can get the care that they need?

[Sir Sajid Javid]

Yes, I agree with the hon. Member. Indeed, those guidelines were changed while I was Secretary of State for Health and Social Care. I remember welcoming them, but the expectation of course was that they would be properly followed. As the hon. Member says, in some 70% of cases that does not seem to be the case. We all want that to be addressed. I hope that the Minister will be able to pick up that point when he responds.

Another example of research is a groundbreaking project on long covid and ME diagnostics called LOCOME. It is co-led by Action for ME, the University of Edinburgh and a computational biology company called PrecisionLife. It is hoped that that new project, which is utilising the data that has been gathered from the DecodeME project, will provide insights that will be able to create the first predictive diagnostic tools for ME and long covid. I take this opportunity to thank the charity Action for ME for its world-leading work on the project, its crucial support and the research and campaigning that it does to improve ME research and outcomes.

It is vital that we continue to support organisations such as Action for ME and researchers in this way. The focus of World ME Day in 2024, this year, will be to build a “Global Voice For ME”. In that spirit, it is important that we collaborate with allies across the globe to further research in this area. However, we know that, even with more research, it will be a long journey to achieve our desired outcomes. That is why improving the experiences of those living with ME, and their families, is also vital.

I know from my own engagement that individuals with lived experience often feel dismissed. I recall a recent Channel 4 report that even highlighted the case of a family who saw social services investigate the care of their daughter because they believed that she was being kept in bed against her will. If it were not for campaigning organisations such as Action for ME, the ME Association, the all-party parliamentary group on myalgic encephalomyelitis, Forward ME and the World ME Alliance as well as the work of incredible individuals such as Sean O’Neill, who I believe joins us today and who has led an inspiring campaign in memory of his daughter, Maeve, the situation would feel almost hopeless. That is how it would feel if we did not have these people battling for more work to be done on ME. It is because of them that the case of this community is being heard, and having served in Government for so long myself, I know that when people speak up with the support of many honourable colleagues from right across the House, the Government must listen.

This year, 2024, marks 55 years since the World Health Organisation officially acknowledged ME. For too long, we have failed to recognise the severity of the condition for thousands of people across the UK. As we mark World ME Day on 12 May, we must renew our commitment to improving outcomes and experiences for everyone affected. It is great to see so many hon. Members from across the House in the Chamber, and I am grateful to everyone who has attended today’s debate in the Public Gallery, as well as those who may be joining online. Where such support exists, there is always hope.

The ambition is to improve the lives of people with the condition today, and to ensure that future generations have a brighter future. Helping make that ambition a reality is now the responsibility of the Minister, and I look forward to his response and the contribution of other hon. Members.

[Dame Siobhain McDonagh (in the Chair)]

I remind Members that they should bob if they wish to be called in the debate.

Tobacco and Vapes Bill

Sajid Javid Excerpts

2nd reading
Tuesday 16th April 2024 Commons Chamber

[Sir Sajid Javid (Bromsgrove) (Con)]

When I was appointed Health Secretary in 2021, we were still in the midst of the pandemic. That challenging time taught us so much about the strength and resilience of our nation, but it also cast an uncomfortable light on truths that we have too often chosen to ignore. In the past, this country has been at the cutting edge of preventive healthcare, but while we have talked a good game on that issue in recent decades, in truth, we have not always delivered.

I would argue that we still face a public health emergency in this country—one that consumes 40% of the NHS budget, ensures that regional inequalities persist, and limits the life chances and opportunities of individuals right across our country. This public health emergency has many causes, and at the top of the list must be smoking, especially of cigarettes. That is why I commissioned Javed Khan to lead an independent review of smoking. I am immensely grateful to him for his excellent work and I am proud that he has led us to this legislation. The title of his report, “Making smoking obsolete”, is the right mission for us to deliver on, especially given this Government’s commitment in 2019 to a smoke-free Britain.

One of the most important problems Javed Khan identifies is the dual impact of tobacco and nicotine. First, it is incredibly damaging to the health of individuals. As we have heard from so many right hon. and hon. Members, no amount of tobacco is safe. Secondly, it is corrosive of personal liberty and agency. Smoking remains the biggest single cause of preventable illness and death in this country, causing, as we have heard, some 80,000 deaths a year. Smokers are 36% more likely to be admitted to hospital and to need social care 10 years before non-smokers. It causes one in four cancer-related deaths. Behind each of these statistics is an individual life, a family and a community impacted by poorer health. It is therefore only right that we take robust action to protect future generations from these harmful products.

As Javed Khan rightly highlighted in his report, the public are often led to believe that smoking is a personal choice, whereas the reality is that nicotine is a highly addictive drug that corrodes personal agency. Four in five smokers start before the age of 20 and remain addicted for the rest of their lives. As we have heard, many people want to give up smoking, and we have heard some personal stories in the House about just how hard that has been, and how many people, sadly, do not succeed. Many struggle to break free from addiction, and the average number of attempts of those who eventually do successfully quit is 30.

I know that some hon. Members have publicly expressed their reservations about the proposal before us, and we have heard that in this debate, but can we honestly say that this drug enhances personal liberty and freedom? It is a nonsense argument. Anyone who makes that argument is choosing to stand up for big tobacco against the interests of their constituents, and to erode people’s personal liberty and remove their freedom to choose by giving them access to a drug. This drug diminishes economic freedom, and it diminishes the wealth of individuals and of our country. Its overall impact across the country is to reduce opportunity and to drive social challenges. Indeed, if cigarettes were first manufactured today, they would obviously never get through consumer product safety testing.

Given that we are where we are and given what we know, it is of course right to protect future generations from this drug and this addiction. Freedom from pain, disease and inequality is one of the greatest freedoms there is, and whether it is tackling burning injustices, levelling up or even the big society, these missions are more than compatible with the legislation before the House. This is a world-leading proposal backed by clinical evidence and supported by a strong moral cause. As surveys have shown again and again—and, again, just recently—it is strongly supported by the general public of all ages. It is the right approach to public health, it is the right approach for our country and it is more than worthy of the support of this whole House.

Oral Answers to Questions

Sajid Javid Excerpts

Tuesday 23rd January 2024 Commons Chamber

[Victoria Atkins]

We are ensuring that community pharmacists have an even greater role in primary care than they have already. For example, we saw the first stage of the roll-out of Pharmacy First in December, with blood pressure checks and contraceptive care being rolled out. I am very pleased that we are on track to deliver the full roll-out of Pharmacy First by the end of the month.

[Sir Sajid Javid (Bromsgrove) (Con)]

The colour of someone’s skin should not have an impact on the reliability of medical devices, but we know that that is what happened during the pandemic for many black and Asian patients. When I was the Health Secretary, I commissioned an independent review of the equity of medical devices from Professor Dame Margaret Whitehead. Her report was handed to the Department in June last year, but the Department has not yet published it or responded to it. I know that my right hon. Friend cares about health inequalities as much as I do, so may I ask her to publish the report, along with a full Government response, as a matter of urgency?

[Victoria Atkins]

I thank my right hon. Friend for commissioning that vital piece of work. I am giving the matter my closest attention, and I hope very much to be in a position to respond to his points in due course.

Urgent and Emergency Care Recovery Plan

Sajid Javid Excerpts

Monday 30th January 2023 Commons Chamber

[Steve Barclay]

We recognise the huge pressure on social care; that is why, at the autumn statement, the Chancellor set out the biggest-ever increase in funding into social care of any Government, £7.5 billion over two years. We are putting more funding in. On the workforce more generally, the Prime Minister and Chancellor have committed themselves to bringing forward the workforce plan, which will set out the longer-term ambition on workforce and will be independently verified. In addition, we are recruiting more staff, as I updated the House, whether that is the 3% more doctors this year than last year, the 3% increase in nurses, or the 40% more paramedics and 50% more consultants compared with 2010. We are recruiting more staff, but the grown-up position is to recognise that there is also more demand.

[Sajid Javid (Bromsgrove) (Con)]

I warmly welcome the plans set out by my right hon. Friend today, but he will know that one reason emergency care faces so much pressure is that successive Governments have not focused enough on the prevention agenda. Indeed, last week’s news that the Government will not go ahead with individual focused plans on cancer, dementia and mental health has concerned many. Can he assure this House that the Government’s new major conditions strategy will be published promptly and will be comprehensive and significant?

[Steve Barclay]

I am happy to give my right hon. Friend that assurance. I assure the House that our commitment to the cancer mission and the dementia mission through the Office for Life Sciences is absolutely there. He is right that we are bringing that together in one paper—I think we should take a holistic approach—but I share his ambition on prevention. In early January, I set out a three-phased approach: first, the £250 million immediate response to the pressures we saw from the flu spike over Christmas; secondly, as I announced today, building greater resilience into the system looking ahead to next winter; and thirdly, the major conditions paper on prevention, which is about bringing forward the innovative work that colleagues are doing through the Office for Life Sciences to impact the NHS frontline much sooner than might otherwise have been the case.

Oral Answers to Questions

Sajid Javid Excerpts

Tuesday 6th December 2022 Commons Chamber

[Steve Barclay]

We are absolutely committed to addressing health inequalities. Rather than simply looking at 10 years’ time, we are looking at the immediate actions we can take, because what matters—[Interruption.] Those on the Opposition Front Bench chunter about White Papers, but what I am interested in is immediate delivery—what we can be doing now, rather than speculating about what is done in 10 years’ time.

[Sajid Javid (Bromsgrove) (Con)]

We are seeing a sad increase in suicide rates across the country. In 2012, the then Government published a 10-year cross-Government suicide prevention plan. Earlier this year, the Government under the leadership of my right hon. Friend the Member for Uxbridge and South Ruislip (Boris Johnson) committed to a new 10-year plan that would be published before the start of 2023. There is no sign of that cross-Government 10-year suicide prevention plan, but maybe I am wrong, and perhaps the Government are about to publish it, because I know that so much of the work has already been done. May I ask my right hon. Friend the Secretary of State to show that he takes suicide prevention seriously and publish this plan as soon as possible?

[Maria Caulfield]

I thank my right hon. Friend and pay tribute to him for all his work in this area; he has driven this agenda forward. I want to reassure him that we are looking at that. He will understand that we have had some changes in recent weeks, but I assure him that tackling the issue of suicide is a high priority, and we will make an announcement shortly.

Women’s Health Strategy for England

Sajid Javid Excerpts

Wednesday 20th July 2022 Commons Chamber

[Madam Deputy Speaker (Dame Eleanor Laing)]

And now I call Sajid Javid.

[Sajid Javid (Bromsgrove) (Con)]

There was a time when I would follow right after the shadow Secretary of State, but not any more. However, I am very pleased to follow my right hon. Friend the Secretary of State, and I welcome him to his new role. He has the privilege of running a fantastic Department that is so important to the British people. He has excelled in every role he has held in Government so far, and I know he will do so again.

I strongly welcome the women’s health strategy—as we heard, it is the first published by any Government. I congratulate everyone involved, including all the officials and especially the excellent Minister of State, Department for Health and Social Care, my hon. Friend the Member for Lewes (Maria Caulfield), who is sitting on the Treasury Bench, and the previous Minister of State, my right hon. Friend the Member for Mid Bedfordshire (Ms Dorries).

Does the Secretary of State agree that, when it comes to women’s health, early diagnosis is essential? I absolutely welcome the commitment in the strategy on mandatory training in women’s health issues for new doctors, but will my right hon. Friend say a little more about what can be done on training for existing doctors and clinicians?

[Steve Barclay]

The work on this strategy was done before I arrived in the Department, so it was down to my right hon. Friend and to the Minister of State, my hon. Friend the Member for Lewes (Maria Caulfield). It is great to have this opportunity to pay tribute to my predecessor for all that he did to drive this agenda forward. He is absolutely right about the importance of training and early diagnosis. That is why addressing the issue of fragmented services is so important. As a respondent said, where women raise concerns, they often feel like a lone voice in the wind—that was a phrase in the strategy that really resonated with me. Having hubs, centres of excellence and the ability to look at that data and identify it early, alongside the other initiatives in which he played a major role as Secretary of State, such as the diagnostic hubs, are all a key part of the delivery of this strategy.

Gender Recognition: Disclosure of Information

Sajid Javid Excerpts

Thursday 30th June 2022 Written Statements

[The Secretary of State for Health and Social Care (Sajid Javid)]

Today, I have laid the Gender Recognition (Disclosure of Information) (England) Order 2022 in Parliament. This statutory instrument will make a minor change under the Gender Recognition Act (GRA) 2004 in order to facilitate the invaluable research being undertaken as part of Dr Hilary Cass independent review of gender identity services for children and young people (the Cass review).

Under the Gender Recognition Act 2004, it is an offence for a person acting in an official capacity to disclose information about the gender history of a person with a gender recognition certificate (GRC). The Act calls this “protected information”, with some existing exemptions, such as where disclosure is to prevent or investigate crime, or the subject of the information agrees to the disclosure.

The order I have laid today will add a further exemption to the GRA so that a closely defined class of people who facilitate, assist and carry out the research for the Cass review will be able to disclose protected information to each other during the course of their work. Without access to information currently protected under the Act, a significant portion of the available data on health outcomes would have to be removed from the study. This would subsequently prevent Dr Cass review from being able to provide robust recommendations rooted in the best available clinical evidence about how this care can best be provided.

This data will allow us to plan the provision of these services from a world-leading clinical evidence base, to promote better health outcomes for those who use these important services. I firmly believe that this will help enable further debate on these issues to be informed by the best available clinical evidence which will better serve everyone, not least children.

I remain committed to upholding the rights and privacy of transgender people, so this data will be carefully controlled. Only those working for a small number of organisations listed in the order and who are involved in the research will be able to access protected information and share it with each other. Furthermore, those within this closed circle will only be able to access and share the data if doing so is genuinely necessary in order to facilitate, assist or carry out research as part of the Cass review.

As an additional safeguard, the order will expire after a period of five years which is the maximum amount of time that we believe the project will take. The order does not allow patient identifiable information to be made public through the course of this research, and any research outputs subsequently published will be fully anonymised.

[HCWS170]

A Plan for Digital Health and Social Care

Sajid Javid Excerpts

Wednesday 29th June 2022 Written Statements

[The Secretary of State for Health and Social Care (Sajid Javid)]

I would like to inform the House that “A Plan for Digital Health and Social Care” has been published today. This document sets out how we will build a more digitised, more efficient and more personalised health and care system.

Earlier this year, I made a speech setting out my four priorities for reform in health: prevention, personalisation, people and performance. We cannot deliver the change We need to see, unless we embrace the opportunities from digital technologies.

We are now embarking on a transformative programme of reforms that will make sure the NHS is set up to meet the challenges of 2048, not of 1948, when it was first established, and also to make the vital changes that are so urgently required in social care.

On 13 June we published a strategy for a data-enabled health and social care sector, “Data Saves Lives”, which draws on lessons learned about the power of data from the response to the covid-19 pandemic. Data Saves Lives includes a range of commitments that will help connect systems and details how we will use data flowing through the digitised health and social care system to continually improve services while maintaining the highest standards of privacy and ethics.

The long-term sustainability of health and social care is dependent on having the right digital foundations in place, and so digital transformation is crucial in achieving and delivering these reforms.

This plan sets how the delivery of health and social care will change, taking forward what we have learnt from the pandemic, and from tech pioneers across the world. The aim is something that we can all get behind: a health and social care system that will be much faster and more effective, and delivers more personalised care.

Digital is not, and will not, be the only means of access to health and social care services, but through it we can ensure that the needs and preferences of individuals are reflected in the services we provide.

Health and social care organisations and partners from industry can use the plan to help shape their strategies to digitally transform services for their populations.

The NHS app will be at the heart of these plans. We saw during the pandemic how people grasped the opportunity to have healthcare at their fingertips.

I am determined to make this app the front door to NHS services, and this plan shows how we will add an array of new features over the coming months and years, with new functionality and more value for patients every single month. My vision is one in which the app is an assistant in your pocket and a permanent feature of how we do healthcare in this country.

With digitised services and a connected system that supports integration and harnesses the power of data, technology can create a transformed health and social care system that is more responsive to the needs and preferences of all people, identifies and reduces health disparities and delivers improved outcomes for everyone.

We have already made huge progress. Over 28 million people now have the NHS app in their pocket, over 40 million people have an NHS login, and most NHS trusts have an electronic patient record system in place. This is on top of unprecedented investment in the digitisation of adult social care, including £150 million of funding for digital adoption that we announced in our recent White Paper.

This plan sets out the next chapter of this story of digital transformation. It sets out a vision of how we will build a more connected and much more efficient system.

The opportunities offered by digital transformation are huge, with benefits over the next decade running to billions of pounds in efficiencies, economic growth and private investment.

That plan includes a raft of other initiatives, £2 billion of funding to support electronic patient records to be in all NHS trusts, and help over 500,000 people to use digital tools to manage their long-term health conditions in their own homes.

Just as we are putting the right technology in place, we also need to make sure that people are confident and supported in using it. The plan also shows how we will relentlessly focus on digital skills, leadership and culture as well as building patient trust, at all levels, so we can make transformation durable right across the board.

This agenda matters more than it did when this pandemic began. I am determined to use the power of technology and the skills, leadership and culture that underpins it, to drive a new era of digital transformation. So that our health and care system, and our country, will thrive long into the future, delivering vast benefits for patients.

I will deposit a copy of the plan in the Libraries of both Houses.

[HCWS159]

Draft Mental Health Bill

Sajid Javid Excerpts

Monday 27th June 2022 Written Statements

[The Secretary of State for Health and Social Care (Sajid Javid)]

I have published the draft Mental Health Bill today for pre-legislative scrutiny and delivered an oral statement to the house.

The draft Bill will enable the Government to deliver on two manifesto commitments:

to ensure that patients suffering from mental health conditions have greater control over their treatment and receive the dignity and respect they deserve; and,

to make it easier for people with learning disabilities and autism to be discharged from hospital

It contains provisions to increase the autonomy and dignity of people who need inpatient support for their mental health, including people subject to the criminal justice system. These reforms are intended to benefit everyone who may be subject to the Mental Health Act, and to address the racial disparities associated with its use.

The draft Bill is also intended to limit the extent to which people with learning disability and autistic people may be made subject to the Mental Health Act, while ensuring adequate community care and support is available for people with these conditions.

The draft Bill heralds a major step change in the rights available to people who may be made subject to the Act. Furthermore, they represent a significant step forward in the Government’s work to respond to the recommendations made by Sir Simon Wessely’s independent review of the Act.

The draft Bill will cover England and Wales.

We look forward to working openly with the committee to ensure that this important Bill is developed with input from stakeholders and all interested parties. This is a once in a generation chance to develop the Mental Health Act to ensure the autonomy and dignity of people who need inpatient support for their mental health.

[HCWS141]

Medical Devices Regulation: Consultation Response

Sajid Javid Excerpts

Monday 27th June 2022 Written Statements

[The Secretary of State for Health and Social Care (Sajid Javid)]

Leaving the European Union has provided a unique opportunity for the United Kingdom to improve the medical device regulatory regime and exercise our new powers as a sovereign regulator, creating a world-leading regime that prioritises patient safety while supporting innovation within the UK MedTech sector. To deliver this ambition and gather views of patients, industry and the healthcare sector, the Government published a consultation on the future UK medical device regulations, “Consultation on the future regulation of medical devices in the United Kingdom”, which is available at: https://www.gov.uk/government/consultations/consultation-on-the-future-regulation-of-medical-devices-in-the-united-kingdom, on 16 September 2021. We received 900 responses and I am grateful to all those who have taken the time to respond to the consultation.

Officials at the Medicines and Healthcare products Regulatory Agency (MHRA) have analysed the consultation responses and have worked with officials within my Department and the Office of Life Sciences to develop the Government response. The response outlines changes that will support innovation within the UK’s life sciences sector and access to medical devices, for example through improving the regulation of novel and growing areas such as artificial intelligence and offering alternative routes to market. This will help to facilitate greater opportunities for small and medium enterprises to capture real world evidence to support the conformity assessment process with the proportionate regulatory oversight, an opportunity which has not existed previously.

The Government are committed to cementing our status as a science superpower by making the UK the leading global hub for life sciences, and the response to the public consultation outlines polices that will help to achieve this.

As part of this consultation, the MHRA received strong support for proposals that will improve patient safety and safeguard public health, for example, through modernising the scope and classification rules of medical devices to deliver improvements in the safety of all medical devices. It also raised points around identified inequities within clinical investigations. I appointed Dame Margaret Whitehead to conduct a review into the potential issues related to equity in the design and use of medical devices and I am pleased that the MHRA will look to address these points within the regulations and supplementary guidance to support this review.

The new transitional measures outlined in the response will be implemented to support continued access to safe medical devices to UK patients, whilst providing time for industry and the healthcare sector to prepare for the transition. In fact, the UK Government are committed to building the UK Conformity Assessed (UKCA) marking as a global exemplar, and it is vital that the necessary building blocks are in place to ensure that the UK market remains an attractive and favourable place to innovate and do business for the benefit of patients and carers. A phased transition into the new regime is critical to its success.

The Government’s response to the consultation will be published on gov.uk today and I will deposit a copy of the response in the Libraries of both Houses.

[HCWS142]