Correction to Written Parliamentary Questions
Andrew Stephenson Excerpts(10 months ago)
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The Minister for Health and Secondary Care (Andrew Stephenson)
I wish to draw the attention of the House to data errors in the Government response to two parliamentary questions—numbers 332 and 12694—tabled by the hon. Member for Ilford North (Wes Streeting). The questions enquired as to the costs paid by the national health service for the outsourcing of teleradiology in the last five years. The data provided by NHS England to the Department for Health and Social Care was incorrect. Therefore, the PQ response underreported the number of scans provided in the requested timeframe. NHS England has been asked by my right hon. Friend the Member for Louth and Horncastle (Victoria Atkins) to urgently conduct a full audit of the quality of the data. Once NHSE has completed the audit, and I am satisfied that the data is sufficiently robust, the House will be updated.
[HCWS286]
NHS Property Services
Andrew Stephenson Excerpts(10 months ago)
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The Minister for Health and Secondary Care (Andrew Stephenson)
I congratulate the hon. Member for Tiverton and Honiton (Richard Foord) on securing the debate. I am grateful for the opportunity to set out the role of NHS Property Services. This subject is understandably of great interest to right hon. and hon. Members across the House.
The hon. Gentleman raised the issue of the future of Seaton community hospital. I will come to that in the latter part of my speech, but let me say for the record that I completely understand his desire to protect a much-loved community health facility. As the Member of Parliament for Pendle, I successfully fought to keep open Pendle Community Hospital in Nelson, and in the neighbouring constituency of Ribble Valley, the new £7.8 million Clitheroe Community Hospital opened in May 2014, so I recognise the importance of community hospitals, not just in offering in-patient care, but in acting as a hub for other healthcare services. It will be most useful for me to first set out to the House why and how NHS Property Services came into being.
Under the Health and Social Care Act 2012, the coalition Government abolished primary care trusts and transferred their commissioning responsibilities to clinical commissioning groups. Their property interests transferred to either NHS trusts or NHS Property Services, which was established in 2013 for this purpose. That decision was made because it allowed commissioners to focus on providing care for patients, rather than managing property. NHS Property Services took ownership of nearly 3,500 local facilities, such as community hospitals, health centres, GP surgeries and care homes. In the past 10 years, NHS Property Services has reduced the size of that estate by a fifth, saving over half a billion pounds of taxpayers’ money, every penny of which has been reinvested into the NHS.
Richard Foord
I understand the Minister’s point about reinvesting the proceeds from selling what might have been regarded as excess NHS property, but my concern relates to where that money goes. My understanding is that, following a sale, half the money might go back to the integrated care board, which would be Devon in this case. The problem with that situation is that it does not take account of the fact that local communities donated the money to build the infrastructure in the first place. That is certainly the case in the Axe valley with Seaton Community Hospital.
Andrew Stephenson
I appreciate the hon. Gentleman’s concern. I hope to provide reassurance in the latter part of my speech that the sale of Seaton Community Hospital is certainly not on the cards and is exceptionally unlikely. However, I appreciate that when property is sold, there is always tension between how much of that money will be reinvested in local communities—many of which have a stake in having created the facilities in the first place—and how much goes into the general NHS pot. The important point for me to land today is that all the money remains within the health services and none returns to the Treasury, so any sales of property from this portfolio are not a way for the Government to generate income, but simply a way of ensuring that the property estate is managed in the most effective fashion.
NHS Property Services was established as a limited company and is led by a board of executive and non-executive directors who are appointed for their property and healthcare expertise, including a departmental shareholder representative. The board’s directors all have the usual responsibilities relating to the proper governance of a limited company, with certain shareholder matters reserved, such as share issue or senior appointments. The board must work within the wider frameworks across Government, such as the Treasury’s guidance on managing public money, which rightly sets out the strict rules for delivering value for taxpayers’ money. The company therefore works with the Department to agree fiscal targets to work within, and is rightly held accountable for its use of public money. However, it is important to emphasise that my Department is not responsible for operational decisions, which are taken by the board and its executive management team.
One reason for the creation of NHS Property Services was to ensure that decisions could be taken without political interference. Although I appreciate that the hon. Member and others across the House may be of the view that my noble Friend Lord Markham, who has ministerial responsibility for NHS Property Services, can intervene to reduce the rents for unoccupied space at Seaton Community Hospital or similar facilities across the country, it would simply not be appropriate for him or any other Minister to intervene in any individual case.
The coalition Government established NHS Property Services through the cost recovery principle, which is the broad framework that the organisation works under. This means that it is funded through charging its costs to the occupiers of its buildings and the recipients of its services. As such, every pound it spends and does not recover is a pound that cannot be spent on delivering frontline care.
The Devon properties were transferred to NHS Property Services on the basis that their ongoing running costs would be funded through rents at market rate and service charges. This approach was taken to give real incentives to local commissioners to take the tough decisions on which properties were most suitable for delivering their clinical strategy, looking at areas as a whole and moving away from a situation whereby subsided property costs could lead to a less effective approach. I accept that that can sometimes lead to tensions about how reasonable charges are set, but the aim is that NHS bodies, and other voluntary and charitable organisations that wish to occupy NHS premises, must factor in the full cost of occupying and maintaining specialist facilities in their decision making.
I will now turn to the future of community hospitals in Devon, including Seaton Community Hospital. As the hon. Gentleman set out in his Adjournment debate in November, Seaton Hospital was part of a group of community hospitals that transferred to NHS Property Services in 2017, when large parts of Seaton Hospital and others in Devon were already vacant. The clinical commissioning group carried out a consultation on the model of community care and a new model of care was introduced, making it more integrated and more community based, with more people receiving care at home. That resulted in a significant reduction in the number of community hospital beds required across Devon. Since then, progress has been made to identify sustainable alternative healthcare uses for vacant spaces in community hospitals in Devon, such as Ottery St Mary and Axminster. In addition, NHS Property Services and Devon ICB have worked with the voluntary sector to support local initiatives in some properties, such as, as the hon. Gentleman will know, the Waffle café at Seaton Hospital.
I understand that Seaton Hospital and some other hospitals still have significant amounts of vacant space. Despite their best efforts, NHS Property Services’ commissioners have been unable to identify relevant services that could fill this gap. NHS Property Services has continued to manage the property, with the costs of the vacant space being charged to the ICB to ensure the costs attributed to the property are fully recovered, but recently the financial challenges facing Devon ICB have called the sustainability of that position into question and it has explored options for alleviating those costs. However, as I explained, simply seeking to pass those costs back to NHS Property Services would not result in the Department having any more money to spend on local healthcare services in Devon.
As I am sure the hon. Gentleman will appreciate, the responsibility for decisions about where to locate clinical services in Devon is a matter for the ICB. It is not a matter for Ministers. However, NHS Property Services is working closely with local leaders to identify options that would help to mitigate the cost pressures arising due to Seaton Community Hospital not operating at full capacity. If, and only if, the ICB determines the property is wholly surplus to its requirements, NHS Property Services would have the responsibility for selling the asset, following Treasury guidelines, but it is important to stress that the site remains an operational site and NHS Property Services therefore has no plans to sell it.
As has been mentioned in the local media, the idea of partial demolition of the hospital has been floated. Again, there are no plans for that course of action, which would very much be a last resort in any event. I believe the site has now been listed as an asset of community value, which means that such a drastic step is exceedingly unlikely to be supported by the local planning authority or other local stakeholders.
Richard Foord
It is true that the property has been registered as an asset of community value. To my mind that gives it a stay of execution, rather than that it is inevitable that it will be preserved intact. NHS Property Services talked through the very many options—I think 28 options—on the table for the vacant space at Seaton Hospital. One of that long list of options is indeed selling off the redundant ward, which could be demolished and used for houses. Did the Minister not know that?
Andrew Stephenson
I know the idea of demolition has been floated in a meeting, but I have been assured that there are certainly no plans for demolition. As the hon. Gentleman will know, an asset of community value nomination was accepted by the local authority, and as an ACV nomination remains live for five years, it will expire in January 2029, although I am pretty sure that local community groups and others would campaign for that to be extended. It is certainly much more than a stay of execution. I hope that has provided suitable reassurance to the local community that the threat of demolition is exceedingly remote, because the local planning authority and other local stakeholders simply would not agree to the demolition of this much-valued community asset.
I fully recognise that the local community has invested in the building of the hospital in the first place, and therefore is a key stakeholder in its future. The ICB and NHS Property Services continue in ongoing dialogue with a range of community groups about potential future uses, and the community has been invited by the ICB to develop a business case for the future use of the property by the end of June 2024. Any future decisions on the future of Seaton Hospital will be taken following evaluation of that business case. I sincerely hope that a financially sustainable solution can be found locally and in the best interests of the people of Devon.
Question put and agreed to.
Physician Associates
Andrew Stephenson Excerpts(10 months, 2 weeks ago)
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The Minister for Health and Secondary Care (Andrew Stephenson)
I congratulate my hon. Friend the Member for Central Suffolk and North Ipswich (Dr Poulter) on securing this debate. He spoke knowledgeably, both as a serving NHS medic and as a former Health Minister.
Let me begin by making a very important point. I addressed it in the Delegated Legislation Committee on 17 January, but it is worth repeating. The role of a physician associate is to work with doctors, not to replace them. Improved patient safety and care is at the heart of the NHS long-term workforce plan, which, backed by significant Government investment, shows our determination to support and grow the workforce. As set out in the plan, roles such as physician associates, who remain supervised by doctors, play an important part in NHS provision, and it is therefore right that we include a range of roles and skills in our multi-disciplinary teams that can offer personalised, responsive care to patients.
It is important to note that the NHS long-term workforce plan commits to doubling medical school degree places to 15,000 a year by 2031-32. That compares with 1,500 physician associate places. In turn, this will mean a major expansion of specialty training, on which we are committed to working with the royal colleges. We have accelerated this expansion by allocating 205 additional medical school places for the 2024-25 academic year, with the process for allocating 350 additional places for the 2025-26 academic year already under way. This demonstrates our commitment to the medical profession, and reaffirms that we absolutely do not see physician associates as replacements for doctors. There are currently 139,200 full-time equivalent doctors working in the NHS in England, which is over 42,100, or 43.4%, more than in 2010. Patient safety remains of the utmost importance, and regulation will help bring further clarity to patients and healthcare professionals on the nature of these roles and their remits.
Physician associates are qualified and trained health professionals. They undergo a three-year undergraduate degree in a health, biomedical science or life sciences subject, followed by two years of postgraduate training, gaining significant clinical experience. Alternatively, some universities now offer an undergraduate degree PA course that includes an integrated master’s degree in physician associate studies. Those courses take four years to complete. Training involves supervised practice with real patients, with at least 1,600 hours of clinical training. It also includes 350 hours in general hospital medicine, and a minimum 90 hours in other settings, including mental health, surgery, and paediatrics. The dedicated medical supervisor is responsible for the supervision and management of a student’s educational process throughout the clinical placement of the course.
Dr Poulter
Earlier, in response to the hon. Member for York Central (Rachael Maskell), I made the point about the variability of biomedical science degrees from different institutions. The GMC would not recognise a biomedical science degree as being adequate for a doctor in training as part of their preclinical studies, because of that variability. Will my right hon. Friend raise that issue directly with NHS England, with regard to putting in place a standardised training pathway for physician assistants?
Andrew Stephenson
My hon. Friend makes a valid point, and that is one reason why regulation is so important. The GMC has assured me that although draft regulations are out there, it will be consulting further on them later this year, so my hon. Friend, the BMA and various others can make strong representations about how the training framework should be provided. With that introductory regulation, the GMC will be responsible for setting, owning and maintaining a shared outcomes framework for physician associates, which will set a combination of professional and clinical outcomes. The outcomes framework will help to establish and maintain consistency, embed flexibility, and establish principles and expectations to support career development and lifelong learning. While at the moment there is significant variability in the system, I hope that the regulations we passed in this House on 17 January will help to provide that clarity and give the GMC the powers it needs to ensure that the training provided to physician associates is of the appropriate quality for the roles we are expecting them to undertake in our NHS.
Physician associates can work autonomously with appropriate support, but always under the supervision of a fully trained and experienced doctor. As with any regulated profession, an individual’s scope of practice is determined by their experience and training, and will normally expand as they spend longer in the role. That must be coupled with appropriate local governance arrangements to ensure that healthcare professionals only carry out tasks that they have received the necessary training to perform. Statutory regulation is an important part of ensuring patient safety, but that is also achieved through robust clinical governance processes within healthcare organisations, which are required to have systems of oversight and supervision for their staff.
NHS England is working with the relevant professional colleges and regulators, to ensure that the use of associate roles is expanded safely and effectively. That includes working with the GMC, royal colleges and other stakeholders to develop appropriate curriculums, core capabilities and career frameworks, standards for continual professional development, assessment and appraisal, and supervision guidance for anaesthetist and physician associates. NHS England will also work with colleges, doctors’ representative organisations, AAs and PAs to identify areas of concern. Specifically, the NHS has committed to working with the Academy of Medical Royal Colleges and individual professional bodies to develop and implement recommendations as a result.
Regulation will give the GMC responsibility and oversight of AAs and PAs, in addition to doctors, allowing it to take a holistic approach to education, training and standards. That will enable a more coherent and co-ordinated approach to regulation and, by making it easier for employers, patients and the public to understand the relationship between the roles of associates and doctors, help to embed such roles in the workforce. Indeed, regulation addresses many of the concerns that we have heard in the debate last month and today. The GMC will set standards of practice, education and training and operate the fitness to practice procedures, ensuring that PAs meet the right standards and can be held to account if serious concerns are raised. GMC guidance sets out the principles and standards expected of all its registrants, and that will apply to PAs once regulation commences. Those standards will give assurance that PA students have demonstrated the core knowledge, skills and professional and ethical behaviours necessary to work safely and competently in their areas of practice and in a care context as newly qualified practitioners.
Rachael Maskell
On that point, can the Minister clarify where the liability will sit if error does occur? Will it sit with the clinician or the consultant who is supervising them? I am not clear on that particular issue.
Andrew Stephenson
In many ways, it will be the same as with many medical professionals. Once we have the situation clarified in regulation, it will not be any different from the personal liability of a doctor or others working in an organisation. Those are the kind of things that the GMC will be consulting on and discussing with stakeholders in the coming months, and is important that all these points are clarified. The hon. Lady was in the debate we had in January, where the tragic case of Emily Chesterton was raised. In that case, unfortunately we saw a PA move from one practice to work in another, and we need to ensure that there is a proper, robust fitness-to-practice regime so that any medical professional can be held to account in such cases for what has happened and, if necessary, struck off the register and no longer able to practice.
Dr Poulter
The Minister is being generous in giving, and we are taking advantage of the slightly extended time we have for this Adjournment debate, but it is an important issue, because it is about patient safety. On that point, he is putting a lot of faith in the GMC doing things quickly, when we know there are existing patient safety issues. Would it not be more sensible to wait for the GMC to put in place the proper regulatory framework, the proper scope of practice and the other pieces of work that are being done before we commit to an expansion of a workforce when we know there is variability and patient safety concerns?
Andrew Stephenson
I feel that I am being criticised from both angles on this point. Some people are saying we are going too fast, and other people are saying we are going far too slow. A number of years ago, we consulted on regulating these professions. We are now moving forward. Those regulations have passed through the UK Parliament and the Scottish Parliament. The GMC has had a long time to prepare. In my meetings with the GMC, it has reassured me that it is ready to go. It will want to consult to ensure that any further concerns that people wish to raise are reflected in the regulations. It wants to ensure that it gets the regulations right, but it has known that they have been coming for some time. We consulted on who was best placed to regulate physician associates and anaesthetist associates back in 2019, so the GMC has had some time to lay the groundwork.
Under the long-term workforce plan, there is a much more significant expansion of doctors, as opposed to physician associates or anaesthetist associates. The number of extra doctors we are bringing in to the health service, as compared with physician associates, is of a magnitude of five to one. I hope I can reassure hon. Members that this is not in any way about replacing doctors. Doctors are still absolutely pivotal to patient care and will be heavily involved in overseeing physician associates, who are not doctors and need to be overseen in clinical practice.
The role of physician associates is in no way a replacement for that of any other member of the general practice team. They work in conjunction with and are complementary to an existing team. Physician associates can help to broaden the capacity and skills mix within a practice team by helping to address the needs of patients in response to the growing and ageing population, but let me be clear that the employment of PAs does not mitigate the need for more GPs, nor does it remove the need for other practice staff.
There will be a wide range of clinicians, such as PAs, who are well suited to providing care in general practice as part of a multidisciplinary team, but GPs remain at the heart of general practice and primary care, and that is not going to change. As we develop and progress with changes to the NHS workforce, it is vital that the expansion of physician associates and their role is delivered safely. GMC regulation is a positive step forward in the safe expansion and further integration of AAs’ and PAs’ roles within the NHS.
I thank my hon. Friend the Member for Central Suffolk and North Ipswich for once again bringing the House’s attention to this important issue. I look forward to continuing to work with him and other right hon. and hon. Members to ensure that we get this right.
Question put and agreed to.
Children and Young People Cancer Taskforce
Andrew Stephenson Excerpts(10 months, 2 weeks ago)
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The Minister for Health and Secondary Care (Andrew Stephenson)
With World Cancer Day this week, I want to take this opportunity to affirm to the House this Government’s commitment to delivering the best cancer services for everyone across England.
I am pleased to inform the House that I am launching a Children and Young People Cancer Taskforce dedicated to tackling those cancers that affect our children and young people. This is part of our commitment to delivering world-leading cancer services—and our mission to save lives.
Although children’s and young people’s cancers make up a small proportion of overall cancer diagnoses, cancers are one of the biggest causes of death in children and young people. While survival is improving, with childhood cancer survival rates in the UK having more than doubled since the 1970s, more invasive cancers have lower survival rates, and the long-term impacts of cancer and of treatment can cause challenges for decades.
In this House we have heard about the devastating impact cancer has on children and young people, and the life-changing impact on their families. I express my gratitude to the families who, despite unimaginable grief, have shared their stories with both Houses, campaigning in the hope that no more families will have to suffer. I commend all the hon. Members who have shone a light on these stories and I welcome their support for this new initiative.
This taskforce represents an opportunity to take dedicated action working across organisations to unify and drive progress. It offers us the chance to meaningfully change how we detect, treat and care for children and young people with cancer.
Through this taskforce, I will be inviting experts to discuss how to improve treatment, detection and research into children’s and young people’s cancers. I am delighted to announce that my hon. Friend the Member for Gosport (Dame Caroline Dinenage) has been appointed as chair of the taskforce, given her campaigning on childhood cancer, her reputation as an exceptional parliamentarian, and her knowledge, experience and dedication.
Areas of focus for the taskforce will include:
Genomic testing and treatment—to ensure all children get timely access to high quality personalised treatments.
Detection and diagnosis—to ensure earlier diagnosis to give children and young people the best chance to beat cancer.
Research and innovation—to explore children’s access to clinical trials, gain greater access to data, target our research funding, and encourage consideration of innovative solutions.
It is important to recognise the excellent work already under way in children’s and young people’s cancers. Rather than seeking to replicate this work, the taskforce is intended to be a unifying force, identifying various projects under way across organisations: including health, science, research, charity and international sectors. It will forge connections, strengthen collaboration, and drive progress in tackling children’s and young people’s cancers.
Following a period of planning and engagement, the taskforce will meet from springtime onwards. Its work will feed into, and align with, the major conditions strategy. I will update the House on its progress in due course.
I will of course keep the House updated on wider progress on cancer. We are improving cancer survival and earlier diagnosis, in part thanks to innovations like lung health checks targeting those at greatest risk of developing lung cancer, with checks mostly carried out in supermarket car parks and other community spaces—reaching those who might not normally come forward. We are also supporting initiatives such as Prostate Cancer UK’s TRANSFORM trial, announced on International Men’s Day, which aims to address some of the inequalities that exist in prostate cancer diagnosis today, and aims to save thousands of men each year.
With this new taskforce, and these ongoing innovations and initiatives, I can assure the House we are taking every step in our mission to improve cancer outcomes.
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Health and Social Care
Andrew Stephenson Excerpts(10 months, 3 weeks ago)
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Andrew Stephenson
There are around 1,400 medicines licensed in the UK, most of which are in good supply.
[Official Report, 30 January 2024, Vol. 744, c. 280WH.]
Letter of correction from the Minister for Health and Secondary Care, the right hon. Member for Pendle (Andrew Stephenson):
An error has been identified in the response given to the hon. Member for Edinburgh West (Christine Jardine) in the debate on Type 2 Diabetes: Availability of Drugs.
The correct response should have been:
Andrew Stephenson
There are around 14,000 medicines licensed in the UK, most of which are in good supply.
Type 2 Diabetes: Availability of Drugs
Andrew Stephenson Excerpts(10 months, 3 weeks ago)
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Each debate is chaired by an MP from the Panel of Chairs, rather than the Speaker or Deputy Speaker. A Government Minister will give the final speech, and no votes may be called on the debate topic.
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The Minister for Health and Secondary Care (Andrew Stephenson)
It is a pleasure to see you in the Chair, Mr Pritchard. I thank the hon. Member for Edinburgh West (Christine Jardine) for raising such an important issue. I want to begin by emphasising that I understand that medicine supply issues are a significant cause of frustration for many of our constituents across the United Kingdom. I also recognise that there have been particular challenges recently with certain medicines. Without diminishing those challenges, it is important that we set them in context.
There are around 1,400 medicines licensed in the UK, most of which are in good supply. The Department is regularly notified of supply issues; thankfully, the vast majority of those can be managed with minimal impact on patients. The medicine supply chain is highly regulated, complex and global, meaning that there can sometimes be supply issues that affect the UK, along with other countries around the world.
There are a number of reasons why a limited number of medicines might be subject to a disruption in supply, such as manufacturing difficulties, regulatory non-compliance, access to raw materials or distribution problems. We cannot always prevent supply issues occurring, but where they do the Department has a range of well-established processes to manage them and help mitigate the risk to patients.
Where there are concerns about supply, they largely, although not exclusively, concern medication to treat the most common conditions. That is exactly the case with what we are talking about today—diabetes—a condition experienced by more than 4.9 million people across the UK. Action on diabetes will be included in the major conditions strategy, as it is an important risk factor for cardiovascular disease. If someone has diabetes, they are twice as likely to have heart disease or a stroke than someone who does not have diabetes, which goes to the heart of what the hon. Member for Edinburgh West said about the importance of ensuring diabetics get their medication.
Jim Shannon
I thank the Minister for his comprehensive and helpful response. Some years ago, when I first came to Parliament there was a diabetes strategy for the whole of the United Kingdom of Great Britain and Northern Ireland. If the Minister could look at it, I think a renewal of that particular strategy would help. It was agreed here at Westminster, but took in all the regions of Scotland, Wales and Northern Ireland. It was a marvellous objective to address diabetes and it seemed to work. I would like to see it happen again.
Andrew Stephenson
The hon. Member makes an important and powerful point, as usual. As he knows, I am a proud Unionist and am keen for us to do as much as we can in collaboration. I recognise that health is a largely devolved matter. However, since I joined the Department of Health and Social Care in October, I have visited Northern Ireland, Scotland and Wales, I have talked about how we can collaborate more closely on things such as research and innovation, and I am sure that we can do more together where the devolved Governments agree. Last night we had encouraging news. Hopefully we will have power-sharing arrangements back in place in Northern Ireland so that we can work together collaboratively to deliver those benefits for patients.
I will finish the point I was making about the major conditions strategy. That strategy aims primarily to improve care and health outcomes for those living with multiple conditions, and it will be centred on prevention. We have heard from a wide range of stakeholders, whose views are informing the development of the strategy. I will meet Diabetes UK this week to continue that engagement.
With regards to the availability of drugs to treat type 2 diabetes, as the hon. Member for Edinburgh West set out, there has been a significant global supply issue affecting glucagon-like peptide-1 receptor agonists—GLP-1RAs—with the shortages driven by an increase in demand for such products for licensed and off-label indications, meaning that the medicine is being used for a different use from that stated on its licence.
I will set out the steps we have taken to manage those issues. We have continued to work with suppliers to take action to resolve the issues as quickly as possible, including expediting deliveries and boosting supplies. In July last year, we issued guidance for healthcare professionals, which took the form of a national patient safety alert on how to manage patients during the supply disruption. Clinicians and prescribers were directed not to initiate new patients on these medicines, which were to be used only to treat their licensed indication, protecting supplies for diabetic patients. Guidance was supported and echoed in a statement issued by the professional regulators.
One of the particular shortages affecting the market at the moment is Ozempic, which is the brand name for semaglutide, which is licensed to treat type 2 diabetes. Wegovy is the same medicine—semaglutide—but licensed specifically for weight management and is generally used at a higher dose than Ozempic. Obesity-related conditions can be serious, so it is right that we support people living with obesity to lose weight, and Wegovy is one option for those with severe obesity and comorbidities. However, it became available for prescription in the UK only on 4 September 2023, having received approval for use on the NHS for weight management in March 2023.
We believe that supply issues with Ozempic have in part been contributed to by off-label prescribing of that medicine for weight loss ahead of Wegovy’s launch. However, the strong and clear guidance that we provided on the use of those treatments only for their licensed indications and our ongoing work with the industry has helped to protect supplies for diabetic patients.
As a result of our continued intensive work with the supply chain, I am pleased to inform hon. Members that the supply position of that particular drug has improved. Supplies of Rybelsus have been boosted to support demand from new patients with type 2 diabetes, patients switching from Byetta injections and patients switching from Victoza injections. The national patient safety alert was amended on 3 January to reflect that positive development. The professional regulators have issued a second statement to highlight that update.
I am also delighted to highlight the fact that the Medicines and Healthcare Products Regulatory Agency gave regulatory approval in the last few days to Mounjaro, an injectable medicine for adults with type 2 diabetes. That will bring an additional treatment option and will mean that more diabetic patients will have access to the medicines that they need.
Sadly, supply is not expected to return to normal due to the issues with certain products, but we will continue to work with the manufacturers, the NHS, the MHRA and others working in the supply chain, to help ensure that, overall, supplies of GLP-1 RAs are available for patients.
Jim Shannon
I think the hon. Members for Edinburgh West (Christine Jardine) and for Wansbeck (Ian Lavery) and I would be interested know about the other option—if I caught you right, Minister—that you mentioned, which is in the form of an injection but is not insulin. Just so we know, is it a different system?
Andrew Stephenson
Sorry, was the hon. Gentleman asking about the approval of the new drug, Mounjaro, which I just mentioned?
Jim Shannon
Yes, I am trying to understand, because I am not aware of it, and neither are the hon. Lady or the hon. Gentleman. It is not insulin for type 2, is it? The Minister mentioned an injection system.
Andrew Stephenson
It is an injectable medicine for adults with type 2 diabetes. It was recently approved by the MHRA. To put a little bit of extra information out there, the National Institute for Health and Care Excellence recommended Mounjaro, the same drug, for the treatment of patients with type 2 diabetes who meet specific criteria. The NHS in England is therefore now legally required, in line with NICE recommendations, to fund its use for eligible patients. The availability of that new medicine in Scotland is, however, a matter for the devolved Administration. The Scottish Medicines Consortium, which makes decisions on the use of medicines in Scotland, has not yet published guidance on Mounjaro. It will be a matter for the SMC as to whether that becomes an option in Scotland.
As I was saying, Mr Pritchard, unfortunately we expect supply chain issues to continue for the rest of the year. Throughout the management of this issue, our guidance has been supported by additional advice issued in Scotland, Wales and Northern Ireland, which has, critically, reinforced the messaging provided by the national patient safety alerts.
Ian Lavery
Does the Minister understand and recognise the benefits of glucose monitoring centres? It is not a supply chain issue, but an access issue. They can and do change people’s lives, but they are not widely accessible. People are very much unaware that they actually exist. If they did and understood that the centres were available from the NHS, it would save the NHS millions if not billions of pounds. It would change the lives of many people, mainly in deprived areas. Can the Minister give a commitment to look at that and see how we can allow more people to access glucose monitoring systems?
Andrew Stephenson
I hear what the hon. Gentleman says and I am more than happy to look at the issue. However, I believe—I may be mistaken—that he is suggesting something that we would routinely advise for type 1 diabetics to be provided to type 2 diabetics. As far as I am aware, the clinical advice does not suggest that we do that, but I am more than happy to look at the issue, because I want to ensure that we support people living with diabetes as much as we can.
Finally, I emphasise that our guidance remains clear that medicines licensed for the treatment of type 2 diabetes should be used only for that purpose. All prescribers, whether employed privately or by the NHS, are expected to take into account the appropriate national guidance. Unfortunately, the supply disruption is a common issue for the UK and other countries around the world, which is both frustrating and distressing for patients. We cannot always prevent supply issues from occurring, but where they do arise, the Department has a range of well-established processes and tools to manage them and to help mitigate the risk to patients. Addressing issues with GLP-1 RAs continues to be a priority for the Department. We will continue to work hard with industry to resolve the issues as quickly as possible. Once again, I am grateful to the hon. Member for Edinburgh West for raising such an important issue.
Question put and agree to.
Milton Keynes Women’s and Children’s Hospital: New Hospital Programme
Andrew Stephenson Excerpts(10 months, 4 weeks ago)
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The Minister for Health and Secondary Care (Andrew Stephenson)
I congratulate my hon. Friend the Member for Milton Keynes North (Ben Everitt) on securing a debate on this important issue. He is a tireless campaigner for better healthcare in Milton Keynes, alongside my hon. Friend the Member for Milton Keynes South (Iain Stewart). Before I talk about the new hospital, I thank my hon. Friend the Member for Milton Keynes North for mentioning the new community diagnostic centres. I am delighted that the Whitehouse health centre is already carrying out tests, checks and scans for his constituents, with another CDC in Lloyds Court shopping centre coming very soon. As he laid out, Milton Keynes University Hospital has already seen improvements to emergency and cancer care facilities. The addition of a dedicated new women and children’s centre through the new hospital programme builds on that record of investment.
Both my hon. Friends, along with the Conservative candidate for Milton Keynes South, Johnny Luk, have spoken to me in detail about the huge difference that the investment will make for local people. My hon. Friend the Member for Milton Keynes North hit the nail on the head in pointing out the smarter hospital design that we have developed as part of the programme, and how it will benefit patients. He is entirely right that it will improve patient care, with features such as more single rooms to give new mums the privacy that they deserve, or for families comforting sick children. The design is a major plus for staff working in our NHS too, providing better lines of sight to monitor patients from nurses’ stations, better IT and equipment so that less time is wasted on non-clinical tasks, and a lighter, brighter environment to work in.
The hospital will also boost the emphasis of my right hon. Friend the Secretary of State on women’s health and maternity care, and I know that she will follow the hospital’s progress with keen interest. As my hon. Friend said, Milton Keynes is rapidly expanding, as the penny drops and people realise what a fantastic place it is to live, work, and raise children, thanks in no small part, I am sure, to his zealous and spirited pursuit of Milton Keynes’ interests in this House. The Government are bearing that important fact in mind, as we work very closely with Milton Keynes University Hospital Foundation Trust on its plans for a new women and children’s hospital, surgical ward block and imaging centre.
In May last year the Government announced a further five hospitals as part of our commitment to build 40 new hospitals by 2030. Structures that were mostly built using reinforced autoclaved aerated concrete—commonly known as RAAC—will be rebuilt by 2030 as part of the new hospital programme, along with two hospitals that were already included on the list. We will not cut any corners when it comes to protecting the safety of patients and staff. We remain committed to every scheme announced as part of the new hospital programme.
I am pleased to inform my hon. Friend that Milton Keynes Community NHS Trust submitted its refreshed strategic outline business case to the programme last week, on 19 January. This will now progress through the appropriate assurance processes, as set out in the Treasury Green Book, to ensure that the trust’s plans are aligned with the national programme approach, are deliverable and provide value for taxpayers’ money. But the intention is very much that these plans will be delivered at pace and with rigour.
I am pleased to inform the House that, up to the end of the 2022-23 financial year, the scheme received more than £11 million for scheme development funding. In the current financial year, we have released more than £600,000 extra, to help the trust develop the business case for the new patient imaging centre. A further £120,000 will be made available for the development of business cases for a multi-storey car park and high voltage supply upgrade. I look forward to receiving further business cases from the trust. I commit to updating my hon. Friend as funding is released for that important scheme. All the money that we have released to date has helped reach key milestones in delivering the plan for the people of Milton Keynes and the surrounding areas, enabling construction teams to crack on early with preparing the site ahead of the main construction commencing in the second half of the decade. The funds also demonstrate our commitment to delivering a new Milton Keynes hospital by 2030 as part of the new hospital programme.
I would like to end by providing a more general update on the ambitious and vital work that we are undertaking as part of the new hospitals programme. I am very pleased that four hospital are now open to patients: the Northern Centre for Cancer Care; the Royal Liverpool Hospital; stage 1 of the Louisa Martindale, also known as the 3Ts hospital—trauma, tertiary and training—in Brighton; and the Northgate and Ferndene hospitals in Northumberland. A further hospital, the Salford Royal major trauma centre, is complete and due to open shortly. Another 17 hospitals are either in construction or in early construction with activity well under way to prepare their sites. This includes surveys and crucial work on non-clinical infrastructure, such as energy centres, demolitions or car parking.
My ministerial colleague with responsibility for the new hospital programme, Lord Markham, has been visiting these sites up and down the country to see at first hand how some of the schemes are progressing. I can assure my hon. Friend that his lordship’s enthusiasm for the programme matches his own.
I thank my hon. Friend for continuing to champion this investment in his constituency and for his continued engagement in the new hospital scheme. He is right to hold our feet to the fire; let the record show that we are committed to every scheme announced as part of the new hospital programme and delivering the new hospital in Milton Keynes by 2030, because I know that he will be holding Ministers to account, as he does so diligently on this and so many other issues.
Question put and agreed to.
Oral Answers to Questions
Andrew Stephenson Excerpts(11 months ago)
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Mr Rob Roberts (Delyn) (Ind)
The Minister for Health and Secondary Care (Andrew Stephenson)
NHS data shows that we have delivered early on our manifesto commitment to have an extra 50,000 NHS nurses, with the number of nurses working in our NHS increasing from around 301,000 in 2019 to 357,000 today. That has been achieved through boosting training and education routes, ethically recruiting internationally and taking actions to improve retention. Measures such as the health and care visa introduced in 2020 support international recruitment.
Mr Roberts
I thank the Minister for his answer. As he knows, the national health service would completely collapse without the input and expertise of clinical staff from around the world. One barrier to those people coming to help us are the high fees for applying for permanent residency. Some nurses from countries such as India and the Philippines are having to take out expensive loans just to feel like they are welcome and able to stay in our country. I have presented a private Member’s Bill to exempt NHS clinical staff from paying those high fees to become residents. Will the Minister support the Bill and work with his Home Office colleagues to find a way to make that a reality for those people who work so hard in our health service?
Andrew Stephenson
I join my hon. Friend in paying tribute to the enormous contribution made by internationally recruited staff to our NHS. As he will know, immigration policy and fees are a matter for my right hon. Friend the Home Secretary. However, our long-term workforce plan supports international recruitment. In addition to the new visa route, we are exempting health and care staff from the immigration health surcharge.
Florence Eshalomi (Vauxhall) (Lab/Co-op)
The Minister will know that without our fantastic workforce, the NHS would not work. I pay tribute to all those hard-working nurses in all our hospitals and care centres, including at St Thomas’ Hospital in my constituency. Does the Minister recognise that in addition to recruiting staff we have to look at retaining staff, who talk about the workload, their mental wellbeing and the fact that the cost of living is having a big impact on them? Does the Minister agree that the Government need to come forward with a wide-ranging plan on addressing workforce planning, pay, training, staff wellbeing and retention?
Andrew Stephenson
I completely agree with the hon. Lady, which is why this Government became the first Government ever to introduce a long-term workforce plan. Retention is one of the key pillars of the long-term workforce plan, and we are already seeing that deliver the result of keeping more staff in our NHS.
Layla Moran (Oxford West and Abingdon) (LD)
Theresa Villiers (Chipping Barnet) (Con)
The Minister for Health and Secondary Care (Andrew Stephenson)
I know this is an issue close to my right hon. Friend’s heart and pay tribute to her for her work as vice-chairman of the all-party group on radiotherapy. The pandemic has of course presented a real challenge to delivering the Government target to diagnose 75% of stageable cancers at stage 1 or stage 2 by 2028, but I am pleased to be able to tell the House that we are coming through that and last year diagnosed more cancers at stage 1 and stage 2 than ever before.
Theresa Villiers
Cancer Research UK has published an ambitious plan, “Longer, better lives”, which reminds us that for some cancer patients just a few weeks of delay can make the difference between whether they can be offered curative treatment or just palliative care. Will the new diagnostic centres being opened by the Government, including at Finchley Memorial Hospital, bring waiting times down and secure that early diagnosis that is so important to surviving cancer?
Andrew Stephenson
My right hon. Friend makes an important point. Diagnostic checks are a key part of the cancer pathway and the 150 community diagnostic centres opened by this Government, including the one at the Finchley Memorial Hospital, will provide earlier diagnostic tests, support earlier diagnosis and bring down waiting times, benefiting millions of patients. These centres have delivered more than 6 million additional tests for all elective activity since July 2021 and we expect the Finchley Memorial Hospital CDC to provide over 126,000 tests for elective care in the next financial year.
Jim Shannon (Strangford) (DUP)
I thank the Minister for that response. Research and development is very important; it means we can find more cures for cancer. My father, who is dead and gone, survived cancer on three occasions; that happened because of advances in finding cures. What is being done to work alongside those in research and development to ensure that even more cancers can be cured and we can go from a 50% rate to perhaps a 60% or even 70% rate for those who live longer?
Andrew Stephenson
I was delighted that one of my first visits in the new year was to Northern Ireland to see some of the life sciences companies, particularly those based around Queen’s University Belfast. That sector in Northern Ireland is flourishing. We are keen to support companies working in research and bring together world-leading universities such as Queen’s with the private sector and the NHS to deliver improved outcomes for all patients across every part of the United Kingdom.
Janet Daby (Lewisham East) (Lab)
The Minister for Health and Secondary Care (Andrew Stephenson)
I know this is an important issue for the hon. Lady in her role as chair of the sickle cell and thalassaemia all-party parliamentary group. We are working hard to provide the best possible care to those living with sickle cell disease. That includes boosting Ro subtype blood donation numbers, identifying improvements in clinical pathways and delivering world-leading treatments, such as the new blood-matching genetic test announced by NHS England yesterday, which will reduce the risk of side effects and offer more personalised care.
Janet Daby
I congratulate NHS England on the launch of the new blood-matching genetic test for sickle cell patients, but it has been more than two years since the “No One’s Listening” report, which made the key recommendation that sickle cell patients receive pain relief within 30 minutes of attending accident and emergency. Why is that still not happening for sickle cell patients, and would the Minister like to meet me and the Sickle Cell Society to discuss how to achieve that?
Andrew Stephenson
I of course would be happy to meet the hon. Lady and the Sickle Cell Society to look at how we can improve patient experiences and ensure that all patients benefit from timely access to the medications they need. I am delighted that she welcomes yesterday’s announcement. It is an example of how the NHS can bring forward world-firsts and is leading the way to transform patient care and improve patient outcomes.
Ian Byrne (Liverpool, West Derby) (Lab)
The Minister for Health and Secondary Care (Andrew Stephenson)
PAs and AAs are an essential part of the reform piece to the long-term workforce plan. I note that the order was passed by the House last night without a Division, so I am grateful for that cross-party support. We are working with the General Medical Council, the British Medical Association and others to ensure that the regulations are fit for the purpose. We look forward to the GMC launching its consultation on the fine print of the regulations very soon.
Mrs Heather Wheeler (South Derbyshire) (Con)
As my constituents have to travel to Tamworth, Burton or Derby for diagnostic tests, can I encourage the Secretary of State to look favourably on a bid for a new much-needed community diagnostic centre in South Derbyshire?
Derek Twigg (Halton) (Lab)
Andrew Stephenson
The NHS long-term plan commits to a number of key ambitions to improve care and outcomes for individuals suffering from cardiovascular disease, including enhanced diagnostic support in the community, better personalised planning, and increasing access to cardiac rehabilitation. Those ambitions will support the delivery of the aim to prevent 150,000 heart attacks, strokes and dementia cases by 2029.
Chris Green (Bolton West) (Con)
The single biggest concern my constituents raise about healthcare is access to GPs, especially in Blackrod and Westhoughton. What more can my right hon. Friend do to ensure we have better GP access?
Samantha Dixon (City of Chester) (Lab)
Andrew Stephenson
The 62-day backlog has fallen by 27% since its peak in May 2020. We know there is more to be done, and that is why we are bringing forward more measures as early as possible. In April 2023, more than nine in 10 patients—90%—started their first cancer treatment within one month of a decision to treat.
James Morris (Halesowen and Rowley Regis) (Con)
Many of my constituents who use Regis Medical Centre have been left angry and frustrated by the botched implementation of an Anima booking system, leading to them being unable to get an appointment or the treatment they need. Will the Secretary of State meet me to discuss how we can learn the lessons from that botched implementation and make sure trust in that GP surgery is restored?
Draft Anaesthesia Associates and Physician Associates Order 2024
Andrew Stephenson Excerpts(11 months, 1 week ago)
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The Minister for Health and Secondary Care (Andrew Stephenson)
I beg to move,
That the Committee has considered the draft Anaesthesia Associates and Physician Associates Order 2024.
It is a pleasure to serve under your chairmanship, Dame Caroline. I will begin by setting out the policy context behind the draft order. Strengthening the future of the NHS workforce remains one of the Government’s top priorities. Anaesthesia associates, AAs, and physician associates, PAs, are already a valued and integral part of the multidisciplinary healthcare team, but they have the potential to make an even greater contribution. Regulating those professions will increase the contribution that AAs and PAs can make to the UK healthcare sector, while improving patient safety and professional accountability.
As well as bringing AAs and PAs into regulation by the General Medical Council, the draft order paves the way for full-scale reform of the regulatory frameworks for all the healthcare professional regulators. This is a rare and significant opportunity to deliver a large-scale programme of reform that will implement improvements to patient and public safety, the system of professional regulation, and the health and care workforce. We are introducing the regulation of AAs and PAs under a new legislative framework without at this stage changing the GMC’s regulatory framework for doctors. That means that the GMC’s overall governance and its regulation of doctors will continue under the Medical Act 1983 after the order comes into effect.
The draft order will give the GMC powers to register AAs and PAs whom it assesses to be appropriately qualified and competent, and to set standards of practice, education and training, and requirements for continual professional development and the conduct of AAs and PAs. It gives the GMC the powers to approve AAs and PAs’ education and training programmes, to operate fitness-to-practice procedures, to investigate concerns and, if necessary, to prevent or restrict an associate from practising.
The legislation provides a high-level framework for the GMC to regulate AAs and PAs, and importantly gives the GMC autonomy to set out the details of its regulatory procedures in rules. The GMC has committed to developing rules and processes for regulating AAs and PAs, which will be subject to public consultation, to enable regulation to begin by the end of this year.
We recognise some concerns about the deployment and planned expansion of the AA and PA roles within the NHS. Let me be clear: the role of associates is to work with doctors and not to replace them. AAs and PAs are distinct, complementary and valued professionals who can enrich the workforce skills mix, freeing up doctors and consultants to spend more time using their specialist skills and training to focus on complex clinical duties and decisions on patient care.
It is important to note that the NHS long-term workforce plan sets out an aim to double the number of medical places in England to 15,000 a year by 2031-32, and to work towards expansion by increasing places by a third to 10,000 a year by 2028-29. We have accelerated that expansion by allocating 205 additional medical school places for the 2024-25 academic year, with the process for allocating 350 additional places for the 2025-26 academic year under way. That demonstrates our commitment to the medical profession and that we do not see PAs or AAs as replacements for doctors.
Currently, more than 139,200 full-time equivalent doctors work in the NHS in England. That is more than 42,100—or 43%—more than in 2010. There are fewer than 3,500 PAs and AAs. Patient safety remains of the utmost importance, and regulation will help to bring further clarity to patients and healthcare professionals on the nature of the roles and their respective remits. Regulation will give the GMC responsibility and oversight of AAs and PAs, in addition to doctors, allowing the council to take a holistic approach to education, training and standards. That will enable a more coherent and co-ordinated approach to regulation, and make it easier for employers, patients and the public to understand the relationship between the roles of associates and doctors. Each nation is considering the operational deployment of those roles within their respective workforces.
In England, the long-term workforce plan reaffirms the commitment to PAs and AAs, and commits to increase the PA workforce to 10,000, and the AA workforce to 2,000, by 2036-37. Over the same period of the long-term workforce plan, we will deliver an additional 60,000 doctors. That is a factor of 5:1 in favour of doctors, which I hope addresses the mistaken belief that PAs and AAs will replace doctors within our NHS. It is vital that this expansion is delivered safely. NHS England is working through partners, including the GMC, the Royal Colleges and other stakeholders, to ensure that associates can be effectively trained and integrated into teams across a range of specialities.
To summarise, the draft order will provide a standardised framework of governance and assurance for clinical practice and professional conduct to enhance patient safety and enable AAs and PAs to make a greater contribution to patient care. I commend the order to the Committee.
Andrew Stephenson
I thank my right hon. Friend the Member for Suffolk Coastal and the hon. Members for Bristol South, for Leicester East, for Worsley and Eccles South, for York Central, and for Wirral West for their contributions to today’s debate.
I would like to turn first to the contribution by the hon. Member for Worsley and Eccles South, who spoke movingly on behalf of her constituents Marion and Brendan Chesterton about the death of their daughter, Emily. I know that the hon. Lady also did so in a very moving fashion during an Adjournment debate, which was responded to by my predecessor, my hon. Friend the Member for Colchester (Will Quince). Ahead of today’s debate, I was very keen to listen to that debate, so I watched it back and I am keen to see what more we can do to learn lessons.
No family should ever have to endure the loss of a child, and no words from me will assuage the family’s grief. However, I hope that by passing this order we are helping to ensure that some lessons have been learned and that we can deliver improved patient safety through better regulation of these roles. I recognise that there have been delays to the previously published timescale for the regulation of AAs and PAs. Although that is in part due to the pandemic, it is important to reiterate that this work is being taken forward as part of a broader package of reforms of regulators, governing a whole range of medical professions. That work is significant and complex. On that basis, a huge amount of work and input from all the regulators and a range of stakeholders has contributed to the draft legislation for AAs and PAs, which will be used as a template for reforms to other regulatory bodies.
Throughout this process, officials from my Department have met the BMA and other stakeholders to develop the policy behind this legislation. On the basis of feedback received through public consultation and additional targeted engagement, officials have made a number of amendments to the draft order to ensure that the legislation is fit for purpose and delivers the flexibility and autonomy required to empower regulators to be able to introduce new regulatory processes that would better serve patients and their registrants. That engagement has been crucial in shaping both our policy intention and the resultant legislation to ensure that it remains a practical piece of legislation that can be used by regulators.
The forthcoming GMC rules consultation, which will follow the passage of this order, represents a further opportunity for the BMA and others to have input into the regulation of these roles. When I met the GMC, I was assured that they were confident that they could bring forward this consultation quickly so that there are no further delays to the timetable of implementing these regulations.
Turning to the AA and PA titles, which quite a few Members have raised today, the physician associate title has been well established in the UK since 2014, and the Government have no plans to change the titles of PAs or AAs. As set out in the National Institute for Health and Care Excellence guidelines, all healthcare professionals directly involved in patient care should introduce themselves and explain their role to the patient. AAs and PAs are not and should never be referred to as medical practitioners, doctors or consultants.
The GMC has published interim standards for AAs and PAs in advance of regulation that make it clear that professionals should always introduce their role to patients and set out their responsibilities in the team. Ahead of regulation by the GMC, the Faculty of Physician Associates has issued guidance for PAs, supervisors, employers and organisations that helps to provide a structured and standardised way of using the title. In addition, NHS England has produced patient-facing materials that have been shared widely with GP practices to support patient awareness and understanding of the PA role.
Barbara Keeley
I thank the Minister for his words of sympathy; I will pass them on to Mr and Mrs Chesterton. On patient-facing advertising, I think a couple of months ago, I raised with the previous Secretary of State for Health, the right hon. Member for North East Cambridgeshire (Steve Barclay), a post from Norfolk and Waveney integrated care system that read, “Got abdominal pain that isn’t going away? A Physician Associate based in your GP practice can help…They are highly skilled at diagnosing conditions”. That was marketing material related to the role, which does not help. We have had tragic cases like Emily’s, and it does not help to have over-egged advertising like that. Can the Minister can say anything about that?
Andrew Stephenson
I completely agree. Things like that do not help, and that is why bringing forward these regulations will help. The GMC is obviously very keen to start its consultation and have the regulations introduced. As soon as this is set out in statute, it will be very helpful, not just for PAs but everybody, particularly employers and others, in ensuring that they never oversell the abilities of a PA and are clear about the role of a PA or AA in an integrated health team.
Turning to the shadow Minister, the hon. Member for Bristol South, I thank her for her contribution and join her in paying tribute to the PAs and AAs already working in our NHS. She asked about the impact on training opportunities for junior doctors, which leads me on to addressing quite a few of the points about why we have decided to go with the GMC as the regulator. The assessment of the most appropriate regulatory body for AAs and PAs was completed in 2019 following a public consultation. The majority of respondents were in favour of the GMC taking on regulation, including the professional bodies representing the two roles and the medical royal colleges. For the record, from a total of over 3,000 responses, 59% of respondents felt that the GMC was the most appropriate, while 20% thought it should be the HCPC.
Regulation of the associate roles by the GMC will allow it to take a holistic approach to the education, training and standards of associate and doctor roles. That will enable a more coherent and co-ordinated approach to regulation, hopefully ensuring that concerns around training places for junior doctors, for example, are addressed appropriately. I am happy to reassure the shadow Minister that I will continue to work with all stakeholders to ensure that we get the regulations right.
I thank the hon. Member for York Central, who spoke knowledgeably about these roles. We would all agree that it has been long recognised that we need to reform the legislative framework for the regulation of healthcare professionals to make things faster and more flexible. The current UK model needs to change to better protect patients, support our health service and help the workforce to meet future challenges.
Successive Governments have considered such reforms, but they have never come to fruition until now. While it is our intention to work as swiftly as possible to deliver reform for each regulator and profession, we will prioritise delivery based on criteria including the size of the registrant base, the need for reform, and our assessment of regulators’ readiness to implement the changes. Based on those criteria, we intend to start working with the regulators to develop reform legislation for their professions over the next couple of years.
The hon. Lady asked about fee levels. I believe the GMC’s current plan is to charge AAs and PAs a fee of £221 per annum, adjusted for inflation. That is what PAs are currently paying the FPA—of course, AAs do not currently pay a fee. The GMC, like the NMC and other regulators, works on the basis of their activities being funded by the fees from registrants, which is an important way of keeping them independent from Government.
This draft order represents a vital step forward to improve patient safety by ensuring that PAs and AAs meet the standards that we expect of all regulated professionals and that they can be held to account if serious concerns are raised. I hope that I have addressed as many of the points raised by the Committee as I can, but I am more than happy to continue dialogue with the Opposition Front-Bench team and others to ensure we get the changes right. I commend the draft order to the Committee.
The Chair
Order. Before I put the question, I have a reminder. We have heard from Members from both sides of the House who are not formal members of this Committee, but only members of the Committee are allowed to vote.
Question put and agreed to.
Resolved,
That the Committee has considered the draft Anaesthesia Associates and Physician Associates Order 2024.
Draft Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023
Andrew Stephenson Excerpts(11 months, 1 week ago)
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The Chair
Before I call the Minister to move the motion, let me I make it clear to the Committee that this is not exclusively a Northern Ireland instrument, as items to which it refers can be sold in the rest of the UK. I will therefore allow this Committee to run for 90 minutes.
The Minister for Health and Secondary Care (Andrew Stephenson)
I beg to move,
That the Committee has considered the draft Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023.
It is a pleasure to serve under your chairmanship, Dame Maria.
I will begin by setting out the policy context of the draft regulations. The Medicines and Healthcare products Regulatory Agency is the UK regulator for medical devices, including in vitro diagnostic devices. The agency is responsible for enforcing the regulations and protecting patient safety. The provisions in the instrument will enable the MHRA to carry out its duties effectively in Northern Ireland.
IVD devices are used to test samples taken from the human body, to monitor a person’s overall health or to treat and prevent diseases. These can include complex tests, such as blood tests to detect HIV or hepatitis and tests for cancer biomarkers, or more commonly used tests, such as pregnancy tests. In May 2022, the EU replaced its regulatory framework for IVD devices with a new regulation, the EU in vitro diagnostic regulation. The EU IVDR has automatically applied in Northern Ireland since 2022 under the terms of the Windsor framework.
This statutory instrument brings important benefits to patients and businesses across Northern Ireland. First, it enables the MHRA and the Department of Health and Social Care to protect patients in Northern Ireland more effectively. Without it, the MHRA will lack important powers equivalent to those in place across Great Britain, leaving NI patients lacking important safety protections available elsewhere.
Secondly, the SI is particularly important because life sciences and medical technology are major growth sectors for the Northern Irish economy. It provides for a stable regulatory environment in Northern Ireland, enabling the whole of the UK to remain an attractive market for research and the development of medical technologies. Thirdly, the SI will unblock UK-wide clinical studies of medical devices and IVD devices that include Northern Irish locations. Last, the SI facilitates consistency between the operation of devices regulation in Northern Ireland and GB where beneficial to Northern Ireland, including through provisions to charge comparable fees and to reflect the unfettered access of NI IVD devices into the GB market.
I will summarise the key provisions in the instrument. It lays down proportionate penalties and gives the MHRA powers to serve enforcement notices for breaches of the EU IVDR in Northern Ireland. Although the MHRA previously had the necessary tools to respond to safety concerns, the draft regulations further strengthen that toolkit. The SI also gives the MHRA powers to designate and monitor notified bodies in relation to the EU IVDR and charge fees relevant to those services. Notified bodies in the UK can carry out the technical conformity assessment of IVD devices for EU regulatory compliance, allowing manufacturers to affix the CE and UK(NI) marks for placing their devices on the market across the UK.
Sponsors of performance studies for new IVD devices in Northern Ireland will need to apply to an ethics committee in the UK for an ethics review, and hold sufficient insurance to meet any potential financial liability in the event of injury or death as a result of participation in the study. The instrument also creates an arbitration procedure for refused performance study applications. It allows performance studies of IVD devices and clinical investigations of medical devices taking place in both Northern Ireland and Great Britain to require only a contact person to be established in Northern Ireland, rather than a legal representative, supported by a sponsor or legal representative established in Great Britain. That reduces the burden on business and makes it straightforward for investigations to include sites across the whole of the UK. This will enable more studies and investigations to go ahead in Northern Ireland.
The instrument includes specific provisions to ensure unfettered access of qualifying NI IVD devices to be placed on the GB market with no additional barriers or burden. This product-specific legislation sits alongside general protections for Northern Ireland’s unfettered access to the rest of the UK market under the United Kingdom Internal Market Act 2020.
IVD devices play a critical role in maintaining patient and public health, and this statutory instrument will strengthen the regulation of these devices in Northern Ireland. It protects patient safety and facilitates consistency in IVD regulation between Northern and Great Britain, which will enable the whole of the UK to remain an attractive market for research and development of medical technologies, bolstering the UK Government’s commitment to the life sciences sector.
Andrew Stephenson
I thank the shadow Minister for her remarks and her support in principle for the instrument. She asked about the MHRA’s capacity to deal with these new regulations. We have received assurances that the agency sees this as a tidying-up exercise. It welcomes the regulations, which it wanted to be introduced, and sees no capacity constraints.
To update GB regulations on medical devices with a specific focus on patient safety, the Government will bring forward secondary legislation in the near future. I cannot be more granular about the timescale, but we do intend to introduce that at the earliest opportunity.
We consulted widely on the draft regulations. I was in Northern Ireland on 4 January, when I spent the day meeting life sciences companies in Belfast and Lisburn. The Government are committed to promoting access to safe and effective IVD devices for all patients across the whole of the United Kingdom, and this SI supports that commitment by strengthening the MHRA’s enforcement powers in Northern Ireland. The MHRA has worked collaboratively with the Northern Ireland Department of Health throughout the development of the regulations, and will continue to do so to ensure their effective implementation and to monitor impacts on the market.
By supporting the regulations, we will ensure that the MHRA can effectively carry out its role as a regulatory authority in Northern Ireland, ensuring that patients in Northern Ireland and in Great Britain have access to safe and effective IVD devices. The provisions will reduce the burden on NI businesses when placing a device on the market. We believe the measure will generate innovation and attract investment into the UK and UK businesses, build on the life sciences strategy, and realise the opportunities in the life sciences sector. I am grateful to the Opposition for their support and to the Committee for considering the draft regulations today. I commend the regulations to the Committee.
Question put and agreed to.