Caroline Johnson MP: speeches

Speeches

• 26 Feb 2025 · Family Businesses · Hansard source

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  My point was that the Minister may be correct that 520 estates will be affected, but others who may be affected will need to plan their businesses and lives accordingly. That is why so many more people are affected by his announcement than simply those who will die next year or the year after.

• 26 Feb 2025 · Family Businesses · Hansard source

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  What Labour seems not to understand is that every business starts with an idea, a hope or a dream, and the individual then puts their whole heart and soul, and every working hour they have, into building their business, often as a whole family endeavour over many generations. It is that, not just the economics and the jobs, that Labour is destroying.

• 13 Feb 2025 · Transport Infrastructure: Rural Communities · Hansard source

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  Sleaford has a beautiful grade II listed railway station in popular use. However, it is very difficult for those with disabilities to access the second platform because there is no lift. I have long campaigned for a lift, and I worked with East Midlands Railway, with the financial support of the previous Government, on a feasibility study for a lift that is in keeping with the heritage station. Will this Government back access for my constituents and access for people to come and visit our beautiful town?

• 13 Feb 2025 · HIV Testing Week · Hansard source

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  It is clear that the battle against HIV is a cross-party issue. We have seen strides and improvements over the years under Governments of different colours. Yes, I was the public health Minister, and we met at an event where I announced the results of the first year of the opt-out testing and its success in reducing infections. HIV testing is really important. I was pleased to see the Prime Minister test earlier this week; that is helpful in reducing the stigma associated with testing. It showed that anybody in any circumstances can have a test. Opt-out testing has identified cases where people who were thought to be very low risk unexpectedly turned out to be HIV-positive. When we brought in the opt-out testing, we targeted first the A&Es in areas of the highest risk, and we need to continue to target those highest-risk areas. In October 2024, the Department of Health and Social Care revealed that over half of those with HIV had been previously diagnosed abroad. Will the Department consider the implications of these trends when it puts together its new HIV action plan in order to achieve the goal of no new HIV transmissions in the UK by 2030? Countries such as Australia and New Zealand require applicants to take an HIV test before they obtain a visa. Have there been any discussions between the Department of Health and Social Care and the Home Office about introducing such a requirement in the UK, as we have for tuberculosis? Guidance from the Office for Health Improvement and Disparities—the Government’s own guidance, effectively —suggests that all men and women, and recently arrived children, known to be from a country of high prevalence should be recommended a test. It might be helpful if the Government followed their own guidance, because if we test the high-risk population, we stand more chance of picking up more cases, which would be beneficial. Under the opt-out testing scheme brought in by the Conservative Government, a patient can explicitly decline instead of explicitly accept an HIV test. It has been rolled out in many A&Es across the country, and I am pleased that it will be coming to more. It has identified hundreds of people who were undiagnosed or lost to follow-up for treatment for HIV, and includes hepatitis B and C. Identification of those cases helps the individuals concerned and helps to reduce transmission across the wider population. Between 2019 and 2020, the estimated number of diagnosed cases in England declined. However, somewhat counterintuitively, opt-out testing suggests there are more cases than we realise. Does the Minister have plans to re-estimate the number of undiagnosed HIV cases that may be out in the community waiting to be treated, in the light of the evidence from opt-out testing? The Opposition welcome the Government’s commitment to fund opt-out testing until March 2026, but NHS services need clarity on funding beyond that point. Will the Minister clarify whether long-term funding for opt-out HIV testing will be considered as part of this year’s spending review? HIV prevention goes beyond testing. A perennial issue is access to PrEP treatment, to maintain the reduction in HIV cases in England. PrEP has been described as a miracle drug, which prevents HIV-negative people from acquiring the virus, and is a key tool to stop new HIV transmissions by 2030. However, waiting times for PrEP are too long—at one point, they were measured in months rather than weeks. What steps is the Minister taking to improve that? The last Government improved access to PrEP across the country by setting up the PrEP access and equity task and finish group. What steps have been taken to implement the group’s recommendations since the Government took office? We have only one Parliament left to finally eradicate new cases of HIV by 2030. We owe it to everyone who has lost their life to this virus, everyone who has faced the stigma—thankfully, that is reduced but it still exists—of being HIV-positive and everyone who is living with HIV today to end new transmissions once and for all. I hope the Government continue the progress of the last Government with their new HIV action plan, and I hope that it will be developed soon. The former Minister, the hon. Member for Gorton and Denton (Andrew Gwynne), said in November that the plan was in production. I hope that it is getting closer to completion and that the Minister can give us an idea of when it will be complete. I hope that today’s debate will inspire thousands of people to get themselves tested.

• 13 Feb 2025 · HIV Testing Week · Hansard source

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  The key is to ask the Government what support they will give to the UN and what conversations they are having with their US counterparts about the benefits to people both overseas and at home of ensuring that the battle against HIV and AIDS is won.

• 13 Feb 2025 · HIV Testing Week · Hansard source

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  It is a pleasure to serve under your chairmanship, Dr Allin-Khan. I congratulate my right hon. Friend the Member for Dumfriesshire, Clydesdale and Tweeddale (David Mundell) on securing this important debate, and I thank the hon. Member for Sittingbourne and Sheppey (Kevin McKenna) for sharing his lived experience of this condition. As we mark National HIV Testing Week 2025, we should be proud of the progress we have made since the ’70s and ’80s in raising awareness of the disease and reducing stigma, but we must reflect on the great challenges that remain in the battle against HIV and AIDS. I pay tribute to charities such as the National AIDS Trust, the George House Trust and the Terrence Higgins Trust, whose work has been at the forefront of the fight against HIV and to improve the nation’s sexual health. The campaign strapline for National HIV Testing Week is “I test”—a message that cannot be repeated enough. Public campaigns such as this have helped to normalise HIV testing as routine and beneficial to both the individual concerned and society at large. Testing is quick, easy, confidential and free. It is the gateway to prevention and treatment and, ultimately, to ending new HIV transmissions. During National HIV Testing Week, anyone in England can order a free postal HIV test, funded by the Department of Health and Social Care and delivered by the Terrence Higgins Trust, as part of the national HIV prevention programme for England. I encourage anyone who is concerned to get such a test and take it. There has been encouraging progress in reducing the prevalence of HIV across England in recent years. In introducing a national HIV action plan, the last Government sought to achieve an 80% reduction in new infections by 2025. Remarkably, the UK achieved the UNAIDS 95-95-95 targets back in 2020: 95% of individuals living with HIV were thought to be diagnosed, 99% of them were on treatment and 98% were achieving good viral suppression. A growing proportion of HIV testing has been taking place by post or at home—44% in 2023 compared with 19% in 2019—which shows that the tests are acceptable to the public and welcomed by them. There has been a substantial increase in the number of tests taking place in emergency departments, with 857,000 in 2023 compared with 114,000 in 2019, mostly because of the opt-out testing introduced by the last Government. We cannot be complacent. Although there have been areas of progress, in recent years we have seen a reversal of hard-won gains in reducing HIV transmission. Data published by the UK Health Security Agency in 2024 shows that the number of heterosexual men and women in England newly diagnosed with HIV has increased by more than 30% since 2022. Around 5,000 undiagnosed people are currently living with HIV in England. HIV and AIDS cannot be solved in the UK without acknowledging the global context. Last year, AIDS-related illness claimed as many lives as the total of all wars, homicides and natural disasters that have ravaged our planet. In parts of southern Africa, in countries such as Botswana and Zimbabwe, more than a fifth of the adult population is living with HIV. Such figures remind us that the global fight with HIV is far from over. I was troubled to hear in a House of Lords debate earlier this week that the head of UNAIDS has warned that global HIV infections could increase by more than 600% by 2029 if the US continues to suspend the UN HIV/AIDS programme. That will mean higher infection rates here in the UK, as communicable diseases do not recognise national borders.

• 12 Feb 2025 · Data (Use and Access) Bill [Lords] · Hansard source

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  rose —

• 12 Feb 2025 · Data (Use and Access) Bill [Lords] · Hansard source

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  I am interested in the hon. Gentleman’s concept of “for the purpose”. Can he be clear that when he is writing his dictionary of definitions, as per clause 140, he will ensure that the definitions are clear so that when people are looking at information on sex, they know whether they are dealing with biological sex or some other definition that the Minister may have come up with?

• 12 Feb 2025 · Data (Use and Access) Bill [Lords] · Hansard source

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  I am grateful to have the opportunity to contribute to the debate, which I have really enjoyed listening to. I particularly enjoyed the contribution of the hon. Member for Scarborough and Whitby (Alison Hume), who talked about writers and stories. Her discussion reminded me of the book I am reading with my son, Andy Griffiths and Terry Denton’s “The 39-Storey Treehouse”, where they have just built a book making machine and have gone off to enjoy themselves while the book is written. I do not quite know how the story will end yet. That reminds us of the balance between the benefits that innovations such as AI can bring and the challenge, as the hon. Member said, of ensuring that people are fairly remunerated for their efforts, whether they be on building the machines or writing the stories. I will direct my remarks to two particular areas of the Bill. First, clause 141 deals with what it refers to as “purported intimate” images, otherwise referred to as deepfake pornography images. There are images of all hon. Members and a majority of our constituents online, fully clothed—at least, I hope so—but individuals can take those innocent images of us or our constituents and use computer software to insert them into another image, generating images that appear to show an individual in an intimate state, undressed or engaging in sexual activity. Why do they do that? For their own sexual gratification, to share with others—perhaps for money—or to humiliate, threaten or control the individual in the image or their loved ones. That has a devastating effect on people’s lives. No hon. Members will be surprised to hear that 99% of victims of that evil crime are women. It is important to recognise the work of Baroness Owen of Alderley Edge. She introduced a private Member’s Bill in this area last December. It was unfortunate that the Government chose not to support her legislation at that time, but I am grateful that they have drafted this clause of the Bill, which has the same effect. It was Baroness Owen’s tenacity and explanations that persuaded the Government to ensure that the threshold is consent, rather than the victim needing to prove intent, in the use of images. She persuaded them to increase the penalty to include imprisonment, reflecting the severity of the crime. She also persuaded them of the need to amend the Sentencing Act 2020 to end the somewhat farcical situation in which an individual will be prosecuted for creating an image and, at the end of the court case, have that same image handed back to them as part of their property. The Government gave the Baroness one further undertaking. Sometimes, images are not discovered immediately after they are taken; or, if a group of images is found on someone’s computer, it may take a while to identify the victim. In such cases, a six-month timeout loophole can cause individuals to get away with these hideous crimes. The Government undertook to amend section 127 of the Magistrates’ Courts Act 1980, which limits jurisdiction to within six months of a crime, to ensure that people caught for a crime after six months has elapsed or whose prosecution takes place after six months have elapsed can still be held to justice and account. I ask the Minister to explain why I cannot find that in the Bill—it may be there and I just cannot find it. If he could clarify that point, I would be grateful. The other point I want to raise is accuracy. We have talked a lot about data, but data is useful only if it is accurate. We will all have heard the story of baby Lilah, a beautiful baby girl born in Sutton-in-Ashfield who was registered as male by accident. It is not very easy to have side notes in digital data. How do we ensure that data is accurate? Three clauses in the Bill may help us with that. Clause 45(6) says that information must be accurate, clause 28(3) and (4) suggest that the Secretary of State must check listed organisations for data reliability, and clause 140 requires the Secretary of State to produce a data dictionary to ensure that we know the definitions of all the data points. The Secretary State spoke about the huge opportunity that data offers the NHS. I refer Members to my entry in the Register of Members’ Financial Interests, as I am a consultant paediatrician. Others have talked about the huge opportunities that AI and data use and research can present to the NHS, but there is also a risk. How does the Minister intend to define sex? The Labour Cabinet and the Prime Minister have repeatedly struggled to define what is a woman. Leaving that to secondary legislation, considered in a small Committee, is not sufficient scrutiny for such an important matter. Earlier in the debate, the Secretary of State referred to the powers that the Bill gives the Secretary of State under secondary legislation and why things are not included in the Bill itself. This issue should be given more scrutiny than that of an SI Committee. It is important to protect women: women’s sport, women’s privacy and women’s single-sex spaces. It is important for intimate care. Many people want to receive intimate care, particularly domiciliary care, by somebody of the same sex. How will they know if the data is not available? Data is also important to protect those with a trans identity. Many blood reference ranges are different for males and females. Haemoglobin varies from laboratory to laboratory, but is roughly 13 to 18 in males and 11.5 to 16.5 in females. If data is not complete or accurate, some individuals may receive unnecessary investigation. Data for screening and other health messages is important. We do not want male people called for cervical screening or men not to receive prostate information.

• 12 Feb 2025 · Data (Use and Access) Bill [Lords] · Hansard source

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  The Minister is being extremely generous with his time.

• 12 Feb 2025 · Data (Use and Access) Bill [Lords] · Hansard source

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  He talked about deepfake pornography—the purported intimate images. One undertaking that the Government gave Baroness Owen of Alderley Edge was that they would remove the prosecution limitation of six months from the offence being committed. However, I have not seen that in the Bill. Do the Government intend to table an amendment in Committee, or would they accept an Opposition amendment at that stage?

• 12 Feb 2025 · Data (Use and Access) Bill [Lords] · Hansard source

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  It is certainly true that across the western world at the moment, there seems to be some confusion on some of the basics of biology and humanity. Data is important for protecting children, too. One data provider listed in clause 28 is the Disclosure and Barring Service. GB News reported that there were 12,000 prosecutions between January 2019 and June 2022 of people on the sex offenders register who did not inform police of data changes. It is crucial that data is accurate and up to date, so will the Secretary of State commit to the integrity of biological sex data in the Bill and in the Government’s datasets? Last September, the UK Health Security Agency released data on sexually transmitted infections by sex and sexual orientation, which is important because of the different epidemiological nature of infections in the different populations. However, the footnotes said that men were defined in the data as cisgender and transgender men, and women as cisgender and transgender women. That somewhat undermines the data integrity and the purpose of splitting the data in the first place. Data that is wrong, unhelpful, misleading or misused by malicious actors can be dangerous. Many are concerned. How does the Minister plan to define sex, and what are his plans for incongruous data? In the debate in the upper House, it was reported that 3,000 people have changed their sex data in their passport, and 15,000 have changed it with the Driver and Vehicle Licensing Agency on their driving licence. It was said in the House of Lords debate that up to 100,000 people may have incongruous official datasets between items such as passports and driving licences. How does the Minister intend to resolve that if we are to have one large dataset for each person? Finally, clause 45(8) sets out that a person may need to pay fees in respect of disclosure. Will we expect people to pay for their own data, and, if so, how much? I know Labour is very keen on increasing taxes, but can the Minister guarantee that the cost will never outweigh the admin cost of producing the data?

• 11 Feb 2025 · Global Health and Immunisation · Hansard source

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  Another time when it is important to work together is during a pandemic, such as by sharing research. Unfortunately, recent history tells us that when Labour negotiates, Britain loses out. Can the Secretary of State confirm that, whatever emerges from discussions with the World Health Organisation, he will not reduce the UK’s capacity to take decisions in the interests of the British people.

• 11 Feb 2025 · Global Health and Immunisation · Hansard source

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  There were almost 67,000 cases of serious antimicrobial-resistant infections in the United Kingdom in 2023. War is increasing such infections globally; 80% of patients in one Kyiv hospital in Ukraine are said to have such infections. The Conservative Government had a plan to tackle that. Do the Labour Government plan to follow that plan, are they on track to meet those targets, and if not, what will the Secretary of State do about it?

• 10 Feb 2025 · Border Security, Asylum and Immigration Bill · Hansard source

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  The Home Secretary is clearly describing the grotesque way in which evil people traffickers encourage people to cross the channel, but my constituents find it difficult to understand why people want to come across the channel from France, which is a lovely country where many people enjoy holidaying and it is so safe. What is her understanding of why people make that journey and how will the Bill specifically help to reduce the number who do?

• 10 Feb 2025 · Border Security, Asylum and Immigration Bill · Hansard source

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  Last year, as part of the Joint Committee on Human Rights, I visited Rwanda to see the accommodation at Hope hostel that was to be provided to people who were moved under the Rwanda scheme. I learned from that visit that, yes, people would have been deterred from going across the channel, but that migrants who were sent to Rwanda would have been well looked after, well cared for and able to set up a new life, free from the war and famine that they were fleeing.

• 4 Feb 2025 · National Cancer Plan · Hansard source

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  I thank the Minister for advance sight of his statement, and I thank all the NHS workers, charities, scientists and others working to help those with cancer. We can all agree that tackling cancer should be a top priority for the NHS. From diagnosing people quickly to starting treatment quickly and using the latest technology and drugs, we all want to see improvements. The recent trends in cancer survival rates are positive. The one-year survival rate for cancer increased by 5.9% between 2010 and 2020, and the five-year survival rate increased by 4.3% in the same period. Despite those improvements, we are not yet where we want to be, and we will be up front about that. In government, we took action to catch cancer sooner and boost survival rates, with initiatives such as lung cancer screening and prostate cancer trials, and we welcome that Labour is continuing with that mission. We will work constructively with the Government on that, as we all want to achieve the same positive outcomes. However, the statement as a whole is rather disappointing. The Minister has told us that this is a cancer plan, but it is not; it is a statement that there is to be one. The Government saying that they want cancer survival rates to increase and that they are going to have a plan does not make it so—we need the plan itself. The announcement of the AI trial in breast cancer is a welcome approach. Artificial intelligence has the capacity to revolutionise the way we diagnose disease, and I am delighted that the Government wish to explore those opportunities. We also very much welcome the relaunch of the children and young people’s cancer taskforce, and are pleased it will be able to continue its valuable work under the co-chairmanship of my hon. Friend the Member for Gosport (Dame Caroline Dinenage) and Professor Darren Hargrave. It is just a shame that the Labour Government wasted seven months by suspending the Conservative taskforce, only to reinstate it now. I note the Minister’s comments about waiting times to start treatment, and we agree that these must improve. I am sure it will not have escaped his notice that NHS Wales, which has been under a Labour Administration for 25 years, has a poorer performance, and I am certain he would not want party politics to affect such an issue. Can he tell the House what conversations he is having with his Welsh counterparts to improve cancer care there? I am also concerned that last month, the Government appeared to quietly abandon the target of ensuring that patients receive treatment a maximum of 62 days from an urgent referral of suspected cancer, despite the Health Secretary having said before the election that a Labour Government would meet that target within the first term. Will the Minister clarify his commitment to the 62-day target? More scanners are, of course, welcome, but what are the Government doing to ensure that there are enough trained professionals to interpret the results of the scans effectively? With charities such as Macmillan and Marie Curie being hit with devastating increases in national insurance contributions, what help will be provided so that they do not have to cut back the vital support and guidance services they provide to cancer patients? Anyone who has faced cancer will know that time is of the essence. The second half of the year—if it is not until December—could be quite a long time from now. Will the Minister therefore be more clear about when he intends to publish the plan? May I recommend using the evidence collected in our 2022 call for evidence, as well as the policies of the interim major conditions strategy, published in 2023, to speed up the plan? The quicker the Government act, the more lives they will be able to save.

• 4 Feb 2025 · Accessibility of Radiotherapy · Hansard source

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  It is a great pleasure to serve under your chairmanship this afternoon, Sir John. As we discuss the future of radiotherapy services, it is essential that we acknowledge the vital role our radiographers, medical physicists and oncologists play, along with all the nursing staff and others, in the delivery of care. The professionals are the backbone of any successful radiotherapy service, and without them progress is impossible. However, it is clear that Governments have faced significant challenges in both staffing and infrastructure. I will take this opportunity to scrutinise the current state of radiotherapy services and the plans to address those concerns. The demand for radiotherapy has increased substantially in recent years, driven primarily by one factor: our ageing population, and the fact that as we grow older our chances of being diagnosed with cancer increase significantly. However, radiotherapy is and remains one of the most cost-effective treatments available within the NHS. Previous Governments recognised that fact, and between 2016 and 2021 they invested £162 million to enable the replacement or upgrade of approximately 100 radiotherapy machines. Since April 2022, the responsibility for investing in new machines has sat with local integrated care boards in England, supported by the 2021spending review, which set aside money for the purpose. As hon. Members have said, to keep up with increasing demand and the need for cutting-edge care, there must be significant sustained investment in radiotherapy services. Radiotherapy is one of the most technologically advanced areas of healthcare, so it is incumbent on us to keep up with the latest scientific developments. It is welcome that the Government have announced £70 million for new radiotherapy machines, but Radiotherapy UK has said that that is not enough and has suggested that the Government invest five times that amount to upgrade out-of-date machines. I would appreciate clarification on that point. The Government have consistently stated in written answers that funding for new radiotherapy machines will be allocated by ICBs using criteria set by NHS England, but how will they monitor the upgrading of the machines across ICB areas to ensure that that takes place and to prevent the postcode lottery that Members have described? Furthermore, NHS England has confirmed that it will give high-performing local systems greater freedom around capital spending. Will such freedoms include capital retention, which can be used to invest in new radiotherapy equipment? One of the most pressing issues is the need for a comprehensive long-term strategic plan for radiotherapy from the Government. The absence of such a plan hinders the ability to think strategically about the future of cancer care and to make the necessary investment to meet growing demand. I am glad that today, World Cancer Day, the Government have committed to produce a new cancer plan. We are told that it will include details about how outcomes for cancer patients, including waiting times, will be improved. Will the Minister indicate whether it will provide specifics on the roll-out of radiotherapy machines in the short, medium and long term? In response to a written question last month, the Minister clarified: “NHS England does not hold any data on the effectiveness of radiotherapy machines relative to the number of doses that they deliver.” Hon. Members have said that newer machines will be able to deliver more doses more quickly. I would be interested to know whether the Department has any plans to collect such data. Of course, any strategic plan should focus not just on the machines, but on the people who operate them—the radiotherapy workforce. What steps are the Government taking to improve the recruitment and retention of the radiotherapy workforce? In a written question, the hon. Member for Westmorland and Lonsdale asked the Government whether they had consulted or planned to consult with clinical experts, the radiotherapy industry, patients or charities about how best to allocate the funds announced in the Budget for the new radiotherapy machines. The Minister responded by saying: “The Department has no plans to consult on this matter”, and reiterated that the funding would be allocated using NHS England criteria. The Minister today announced the plan to produce a cancer strategy. Will that include radiotherapy? Will he commit to working with Radiotherapy UK and providers to improve access to radiotherapy treatment where it is currently lacking? The hon. Member for Westmorland and Lonsdale (Tim Farron) made a very compelling case about long journeys. He spoke about a service in his constituency, and there are others that are similarly affected. We know that earlier treatment affects survival rates. I asked the Minister a question in the main Chamber earlier about the 62-day target, and I did not hear him answer. Will he confirm that he intends to stick to the Health Secretary’s previous commitment to reaching the 62-day target by the end of this Parliament? In addition to Government investment, the private sector plays a role in ensuring the future success of radiotherapy services. The NHS has signed a significant partnership agreement with the independent sector to increase capacity for diagnostic and elective procedures, which will help to reduce waiting times, but it is not clear whether that agreement includes treatment equipment such as radiotherapy machines. Will the Minister confirm whether the Government will work with the independent sector to upgrade equipment such as radiotherapy machines? A partnership that includes capital investment in radiotherapy equipment could ease the burden on the NHS and speed up access to treatment for patients. I know the Minister is hugely motivated to do all he can to improve cancer care, as we all are. This debate should have helped to give him a steer on how that can be achieved.

• 3 Feb 2025 · School Accountability and Intervention · Hansard source

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  How many structural interventions does the Minister expect schools to get each year—not RISE interventions but structural interventions?

• 3 Feb 2025 · AstraZeneca · Hansard source

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  Did the Government’s rise in national insurance contributions and the over £400,000 a year extra that AstraZeneca would have needed to pay for the site contribute to its decision to withdraw?

• 3 Feb 2025 · Points of Order · Hansard source

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  On a point of order, Madam Deputy Speaker. Like my right hon. Friend the Member for Aldridge-Brownhills (Wendy Morton), I am experiencing difficulties in getting responses from the Government. Back in November, along with other right hon. and hon. Members, I wrote to the Chancellor about budgetary measures, but we did not receive a reply. I raised that on 3 December —during Treasury questions—and again on 27 December, and I chased the Government further on 14 January, but we have still received no response. A food business in my constituency wanted some support with exporting last summer. We chased the Government on 5 August, 24 September, 12 November, and 6 and 28 January, but we have received no response. Finally—this is my final example, rather than the final response that is missing; I could give many more examples—a constituent had a problem involving vehicle excise duty, so I wrote to the Government on 4 October. Again, despite that being repeatedly chased, there has been no response. What on earth can Members do? Either the Government do not know the answers, or they have complete disrespect for the House, its Members and my constituents in not providing them.

• 3 Feb 2025 · Draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 · Hansard source

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  When the Minister talks about £1 million, is that the benefit to businesses in the current level of trials? Or is that his estimate of the rise in the number of trials as a result of the changes?

• 3 Feb 2025 · Draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 · Hansard source

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  It is a pleasure to serve under your chairmanship, Sir Desmond. The Minister said that 17.5 million people in the United Kingdom are living with a long-term health condition. Every time the news comes on of an evening, they will hope that it brings some hope of a new treatment that promises the cure or effective treatment of their condition, or the condition of one whom they love. Unfortunately, the news today tells them that AstraZeneca has cancelled its investment in the UK, which is a big loss for life sciences and cures for people in this country. Never the less, these regulations are a positive change. This instrument will reform the UK’s clinical trial regulatory regime with the aim of delivering a more “proportionate, streamlined and effective clinical research environment” by amending the Medicines for Human Use (Clinical Trials) Regulations 2004. These draft regulations are a response to a public consultation launched under the Conservatives in 2022, which asked for feedback on how the regulation of clinical trials could be improved and strengthened in the UK. I agree with the Minister that we have an opportunity, now we have left the European Union, to design a world-class, sovereign regulatory environment for clinical trials that supports the development of innovative medicines and ensures that the UK retains and grows its reputation as a world-leading base for life sciences, generating opportunities for skilled jobs in the UK. As Conservatives, we welcome innovation and want to support UK patients getting early access to new and innovative treatments. For those reasons, we welcome the changes. Among the many changes this instrument would make, it would legislate for a notification scheme to enable lower-risk clinical trials to be automatically approved by the licensing authority, where the risk is similar to that of standard medical care. A favourable opinion from an ethics committee would still be required to safeguard people taking part in the trial. The impact assessment estimates that around 20% of initial clinical trial applications would qualify for the notification scheme. When asked about eligibility criteria for the scheme, the Medicines and Healthcare products Regulatory Agency explained that an application would be eligible if the medicine being investigated is used in line with its authorised use or established practice, supported by evidence; a previous similar clinical trial of a product has been approved in the last two years; or the same trial has been approved in the United States or a European economic area country. While the clinical trial sponsor is responsible for determining whether the application meets the criteria for notification, the MHRA stated that a verification process would ensure their determination is correct. The notification scheme currently exists on an opt-in basis. The MHRA says that that has reduced the time required to initiate lower-risk clinical trials by more than 50% without compromising patient safety. That will clearly help people to get the new treatments quicker, and is to be welcomed. We consider that the draft regulations will simultaneously remove obstacles to sponsors’ carrying out clinical trials, while ensuring the focus remains on protection of those participating in the trials. It will remove the aspects of legislation that are more prescriptive, in favour of introducing greater flexibility and more risk proportionality, to reflect that trial design and operation is evolving with innovations in the products that trials investigate. Ultimately, these proposed new requirements will ensure that trial participants and their safety are at the heart of legislation. One thing I would like the Minister to clarify is that on the one hand he was saying that this change in regulation will be revolutionary for people getting trials and drugs more quickly, whereas on the other hand he gave a de minimis amount in terms of the financial benefit. Could he explain that contradiction?

• 30 Jan 2025 · Tobacco and Vapes Bill (Sixteenth sitting) · Hansard source

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  The only thing that would inhibit the Government is not getting the work done in time—if they did not hand their homework in on time. We have all been at school and we know that if we do not hand our homework in on time, it causes us trouble. The simple fact is that the purpose of the clause is to get the Government to do their work in an appropriate time frame. So that is the point—we do not want to create a whole load of capacity in this legislation for the Government to do stuff only for them to put it on the back burner because they are too busy, do not have the time and do not see it as a priority. Legislating to have the power to do things and doing them are not the same thing. The purpose of this new clause is to make sure that the Government get them done.

• 30 Jan 2025 · Tobacco and Vapes Bill (Sixteenth sitting) · Hansard source

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  I thank the Minister for his detailed response to this new clause. Can he confirm that the reports are produced on an annual basis, and will continue to be produced on that basis by both relevant authorities through this Parliament?