(3 years, 1 month ago)
Commons ChamberIt is a great pleasure to follow the hon. Member for Swansea East (Carolyn Harris), who has given a tour de force presentation of her Bill. She brings her characteristic charm and leadership with which she approaches all her campaigns. I am sure that when she was drawn at No. 3 in the private Members’ Bill ballot, the Government gave a collective intake of breath and thought, “Oh, my goodness! What is she going to bring in?” She has used that position to bring forward a Bill on a very important subject, which, as she says, affects 51% of the nation’s population. I am hugely grateful to her, not least because I have been banging on about exactly these subjects myself for a while. She is quite right when she says that there has been barely any reference to this debate or these issues in Hansard. Dare I say it, but that is because for a long time there just were not enough women in this place.
I thank the hon. Lady for giving way on that point, because this point was burning inside me while I listened to my hon. Friend the Member for Swansea East (Carolyn Harris) making her fantastic speech. Does the hon. Lady agree that this debate is one of the benefits of a truly diverse Parliament? Any time anybody asks us why it matters that there are more women in Parliament, here we have it—this debate would not have happened without more women being in Parliament, with all of our diverse experiences, alongside our male allies. Does she agree?
I could not possibly disagree with that. The really sad thing is that it has taken a century of women having the vote to get to a critical mass where we can now finally discuss these things. I hope that we will make up for lost time. This Bill is a very important one.
One of the most important things that this Bill will achieve is that society will start taking these subjects seriously. There is so much about women’s health that has been taboo for a very long time. I have spoken a lot previously about problem periods, and about the fact that endometriosis continues to go undiagnosed, causing massive problems for women and girls who suffer with it. It says everything. Again, one in three women suffer fibroids. We all think that it is normal. We all think that this is what a woman’s lot is, and we are encouraged to suffer in silence, and it really should not be that way. It is interesting to make that observation in the wake of the Cumberlege report, “First Do No Harm”, which, obviously, looked at these issues from the perspective of vaginal mesh.
Over and over again, we see the same issues raised. Women are not heard. The quality of conversations that women have with their medical practitioners is just not good enough. Too often, women feel fobbed off. That struck me when I was a Minister in the Department of Health and Social Care. A number of female colleagues would share with me their experiences. I just thought, “For goodness’ sake, we are pushy, opinionated women who are elected to this House! If we are not being heard, then God help the rest of the female population.” It is really important that we shine light on what can be expected. As the hon. Member for Swansea East so eloquently explained, presenting to a GP with symptoms, which ended up with her being sent away with a prescription for anti-depressants for something that all women will go through just is not good enough. I cannot believe that we are still having this conversation. The more that society in general understands what comes with menopause, the more that we will be able to have those sensible conversations and the more that we will be able to manage our conditions well. We must acknowledge this throughout society. We have to start in schools and make sure that everyone understands the life course around women’s health and what they will go through.
(4 years, 9 months ago)
Commons ChamberThat is incredibly important, and we have to keep reiterating it, even though we may have heard it a thousand times—I may have said it even more than that. Although there is a huge debate about coronavirus and what we can do as a country, there are some really simple things that are really effective.
I have two questions for the Secretary of State. I thank him for his commitment to keeping this place open, which I agree is very important.
What guidance will the Secretary of State give to prepare us for what may be necessary, such as the possibility of having to cancel events, constituency surgeries and so on? I have staff, as I am sure most Members do, who are already concerned about how they should be protecting us and, most importantly, themselves and their family and friends.
Secondly, what is the Secretary of State doing, or talking to colleagues about doing, for those on very low incomes who have to self-isolate and are unable to order food through the internet because they have either no credit card or no internet?
First, the Leader of the House, Mr Speaker and the House of Commons Commission, advised by Public Health England, are best placed to come forward with guidance on the details of how this place can run should a significant number of colleagues and, potentially, staff be unwell or self-isolating.
Secondly, it is very hard, from central Government, to make sure we reach all the people who will need the sort of support the hon. Lady describes. This is best done through local authorities, which is why we have introduced a £0.5 billion fund for local authorities essentially to do whatever they think is necessary in these circumstances.
(4 years, 10 months ago)
Commons ChamberI beg to move,
That this House notes that almost ten years of Government cuts to council budgets have resulted in a social care funding crisis which means 1.5 million older people have unmet social care needs; further notes the increasing funding gap for adult social care; believes proposals from the Government for access to additional funding for both adult and children’s social care will do nothing to ease the crisis or address the funding gap; and calls on the Government to bring forward as a matter of urgency plans to reform social care including plans for free personal care.
It is right that we have a chance to debate social care today: it is two weeks ahead of the Budget and there is the ever present hope that the Government will announce much-needed social care reform. This reform is long overdue. After nearly a decade of cuts, our social care system is on its knees. For the people who rely on social care and for their families, the reality is that things have got much worse under successive Conservative Governments. Every day last year, 2,000 older people who had approached their local authority for help with social care were turned down. The result is that there are currently 1.5 million older people who are not getting the support they need—each one struggling to cope with basic everyday tasks. This can mean people left trapped in bed all day or going unwashed all week, because family carers can visit them only on the weekends, and those are the people who are fortunate enough to have help from unpaid carers. Around half the 1.5 million get no help at all—not even from family and friends. They cope as best they can until they end up in hospital, and then they cannot get out of hospital because they can only be discharged safely once a social care package is set up, with the local authorities struggling to find the funding for it.
Another failure in our social care system is where people are held in entirely inappropriate institutions because the local authority cannot fund the care they need to keep them safe in the community. There are 2,200 autistic people and people with learning disabilities who continue to be detained on in-patient wards. This is one of the most egregious failures of our social care system. They should be able to live in their own homes with a support package, but the funding is not there. For eight years the Government have been promising to end this scandal, but they have failed to do so.
My hon. Friend is making a great start to a very important speech. Does she agree that it is quite astonishing that the Equality and Human Rights Commission has been forced into a position where it is having to threaten to take action over the Government because of their failure to accommodate people with autism and learning disabilities, and it is people who are suffering as a result?
I absolutely agree with my hon. Friend. The only way that we will see real change is if the Government put in funding to provide the housing and support needed for those people currently trapped in inappropriate institutions. I first raised this issue with the Secretary of State in October 2018, citing the case of a young autistic woman called Bethany. It took 14 months before Bethany was moved out of a seclusion cell and into a more supported environment. Now we have, as my hon. Friend has said, the Equalities and Human Rights Commission launching a legal challenge against the Department for its failure to move those 2,200 autistic people and people with learning disabilities out of those inappropriate units.
We must see action on this issue, because it is a national scandal. We need to see reform so that more people can get the care they need, rather than being left to struggle on alone. Even when people are able to access publicly funded care, there is no guarantee that it will be of acceptable quality. Last year, one in six social care services was rated by the Care Quality Commission as “inadequate” or “requires improvement”. That can mean care homes that are so unclean that residents are at risk of picking up infections. It can mean home care agencies that have not even carried out basic checks on their staff, or home care staff being so rushed that they do not have the time to take off their coats during a visit.
Twenty per cent of councils in England and Wales still commission 15-minute care visits. That is clearly not long enough to provide care. It is not long enough to get to know someone and support them to do the things that they want to do.
(4 years, 10 months ago)
Commons ChamberThere was actually quite a long process. As I say, Paterson practised between 1997 and 2011, and there was quite a long process of reporting and of concerns being raised about his behaviour and his practice. Eventually, somebody listened; I believe that it was a new chief executive at the Spire hospital trust at the time.[Official Report, 12 February 2020, Vol. 671, c. 10MC.] Somebody spoke out to him, he looked at the history of what had happened and he decided to take action. That is not good enough, however, because reports had been made on a number of occasions previously. In fact, there were two reports. One, by a consultant, looked at 100 of his cases in 2011, but no action was taken. Another report, by another NHS consultant, downplayed and focused on the wrong elements of Paterson’s care, and it took somebody to speak to a new chief executive for action to be taken. The process was all wrong, but that is how it was then, and it is very different now.
As I have said, the GMC has introduced revalidation and appraisal. We have been speaking to it, and we want it to make that process more robust so that we can assess doctors in a more appropriate and frequent way. The CQC is holding the private sector to account, as well as the NHS. Those of us who have been here for more than a few years know that a few years ago the CQC was not the organisation that it is today, and it is now much more robust and effective. We therefore hope that we can pick up cases such as this as they happen. However, the only way to crack patient safety in this country is if somebody who is practising alongside a surgeon, doctor or nurse speaks out, and for those to whom they speak to listen, so that we can act.
I thank the Minister for her remarks. I welcome her mention of culture and cultural change, but I wish to push her a little further. She spoke about cultural change in relation to whistleblowers, but that is after something has gone wrong. I would like junior clinicians to feel able to challenge senior clinicians before something has gone wrong. Is anything happening to shift the culture, so that a culture of learning is encouraged among senior clinicians, and so that they welcome challenges and questioning from junior clinicians, in order to prevent something such as this from happening?
(4 years, 10 months ago)
Commons ChamberYes, absolutely. If we use technology to set up a better booking system for GPs, it turns out that we reduce by a third the number of times people do not attend.
Somebody on the Opposition Front Bench just shouted, “Oh, come on!” when I talked about saving huge amounts of money by reducing by a third the number of people who do not attend a GP appointment. They should get with the programme, and use the best technology to support our staff in the NHS.
(5 years, 8 months ago)
Commons ChamberUrgent Questions are proposed each morning by backbench MPs, and up to two may be selected each day by the Speaker. Chosen Urgent Questions are announced 30 minutes before Parliament sits each day.
Each Urgent Question requires a Government Minister to give a response on the debate topic.
This information is provided by Parallel Parliament and does not comprise part of the offical record
My hon. Friend makes a good point. More than 80 prescriptions have been made, but that is for both THC and CBD. Of course, THC brings risks—the active elements within cannabis do bring risks. There are also benefits, as I have seen very clearly. It must be for a clinician to decide the balance of those risks. I have enormous sympathy for the families, having heard their personal testimony about the massive benefits for their children, who sometimes, as my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) said, have 300 seizures a day. Having seen that and looked them in the eye, I understand the benefits. However, it has to be a clinician who makes that judgment. I am not medically qualified and cannot overrule a clinician, but there are clinicians available who can provide a second opinion, and that is what I can ensure.
I am grateful to the Secretary of State for what he has said so far, but I have spoken with a neurosurgeon in my constituency who says that one of his anxieties is not being able to give good advice to parents whom he suspects might be trying to access medical cannabis through not wholly legal routes, because he is unsure what the law is. I agree with the Secretary of State on the need for clinical evidence, so what more information can he give us on the timescale? When will we see the health education research that he talks about? In the meantime, why can we not use the evidence of clinical trials conducted elsewhere?
The evidence of clinical trials from elsewhere can and should be used. All international clinical evidence should be brought to bear on such decisions and has been in the case of CBD. As for how quickly things will happen, the answer is, as the hon. Lady would imagine, as soon as possible.
(5 years, 9 months ago)
Commons ChamberIt is a pleasure and an honour to follow the hon. Member for Bexhill and Battle (Huw Merriman) and, in spirit, the right hon. Member for Chesham and Amersham (Dame Cheryl Gillan), who we truly salute today and all of this year as we mark the 10th anniversary of the Autism Act 2009. Both he and she will agree with me that there is still a lot to be done. I am proud to be one of the all-party group’s officers chairing one of the commissions marking that anniversary and measuring progress; the one I am chairing is on employment and autism and that will be the subject of my remarks today. I also thank my staff Mike Davies and Ravina Shah, who lead for me on autism, and the work of the National Autistic Society, particularly our regional rep Henry and the Bristol Autism Spectrum Service.
According to a recent report by the National Autistic Society, only 16% of working-age people with autism are in full-time employment, and only 32% of people with autism are in any kind of paid employment. That contrasts with the fact that 47% of working-age disabled people are in employment and 80% of working-age people without disabilities are in employment.
I am sorry, but I am going to try to stick to the time limit. A lot of Members want to speak.
The 2017 Tory manifesto pledged to see 1 million more disabled people in work by 2027. However, I am not sure that the Government are currently measuring the employment gap for people with autism, so I ask the Minister whether she is able to record the number of autistic people in work in the labour force survey and if not whether some progress can be made.
More than half a million people in the UK are on the spectrum, which is more than 1% of the population. More and more people are being diagnosed, with a twenty-fivefold increase in recent years. People often, although not always, need specific help to be able to find and keep a job, so I ask the Minister to urge Jobcentre Plus to provide adequate autism awareness training.
The National Autistic Society campaign “Too much information” launched in 2016 was the UK’s biggest ever campaign aimed at improving public understanding of autism. The campaign’s report found that 77% of unemployed autistic people want to work and that 40% currently working part-time wish to work more hours. People with autism want to work in a wide variety of roles and respondents to the survey found that ideal work environments vary hugely, from the arts and museum work to scientific research and development. We need to break stereotypes about autism and employment and recognise that the underemployment of people with autism is an issue as well as unemployment.
More needs to be done to improve the lives of people living with autism. I have changed my own employment practices by altering job descriptions to be more accessible, and I am very proud of the two fantastic members of staff I have employed as a result; they are brilliant. I was also, I believe, the first MP to hold a surgery specifically for people on the autism spectrum. I know others have followed suit, which is fantastic, and no doubt they have done a better job. I am committed to making Bristol an autism-friendly city; I made that commitment when I was first elected.
My constituents tell me that many people on the autistic spectrum encounter barriers to finding employment. It is right that we do everything we can to end social isolation. One way of doing that is to ensure that autistic people have the same access to employment as everybody else. Employers, trade unions and public services can all play a part in this. Unfortunately, that exclusion leads not only to autistic people feeling left out but to us missing out on their skills and qualities. They have potential which is too often untapped. This is also about their families and the wider economy. We should all pledge to do everything we can to increase the employment of people on the spectrum.
However, employers say they feel under-equipped and the National Autistic Society survey found that 60% worry about getting it wrong and do not know where to go for support and advice about this. As an officer of the all-party group on autism chairing the commission on employment of people with autism, I will be involving people with autism but there will also be discussions for us there about practical measures and the ways to get people with autism into employment that make sense and fit their potential, but do not discriminate.
I will continue to campaign for Bristol to become a truly autism-friendly city. I am delighted that so many of Bristol’s employers are so keen to join me in achieving this goal. I have spoken to many employers over the last year or so about that. Every single one I have met has taken various steps to make their employment practices more accessible. So may I ask the Minister what the Government will do in turn to help to close the autism employment gap? If she is not able to answer that today, will she consider coming to our commission inquiry to discuss it further?
I thank all those people on the autistic spectrum who have not just inspired me but helped me, taught me and frequently challenged me on how I as a politician and an employer can do better. Autism is in my family. My autistic teenage nephew is doing really well and has so much to offer and many talents, but he is going to need employers to understand his autism and that may in turn mean that they need help. So I want every one of us here to take that away from today’s debate: the need to help employers to do better to close the autism employment gap.
(5 years, 9 months ago)
General CommitteesIt is good to see you in the Chair again, Ms McDonagh. This makes it two in a row; you obviously enjoyed last week, so welcome back.
There are only two statutory instruments before the Committee today. The Government are committed to ensuring, as I have said before, that our world-class—as they certainly are—enforcement agencies and regulators can continue protecting the UK’s public health and biosecurity when we leave the European Union. That includes ensuring that imported food and feed that pose a risk to human or animal health continue to undergo border checks and controls. The measures will ensure that bodies such as the Food Standards Agency, for which I am responsible, and the Animal and Plant Health Agency, which is a Department for Environment, Food and Rural Affairs agency, are suitably empowered to continue working to ensure that the law is followed across the food chain.
Although the Government’s priority is to secure a deal—and I believe that there may have been some developments in that respect overnight—to ensure an orderly departure from the European Union, the role of any responsible Government involves preparing for all possible outcomes. To continue protecting consumers, our food and feed safety legislation, including that relating to imported food and feed, must be able to function effectively in the event that no withdrawal agreement is in place. That will also ensure that there is minimal disruption at UK sea ports and airports. It is for those reasons that the SIs have been made under the powers in the European Union (Withdrawal) Act 2018, which, I reiterate, is a housekeeping Act that allows us to transpose European Union legislation and regulation on to the UK statute book.
As to the purpose of the instruments, official controls verify business compliance with food and feed law across the agri-food chain. In the United Kingdom, responsibility for delivering official controls is divided between central competent authorities, such as the Food Standards Agency and Food Standards Scotland north of the border, and local authorities.
The draft Official Controls for Feed, Food and Animal Health and Welfare (Amendment etc.) (EU Exit) Regulations 2019 are designed to ensure that the official controls system delivered by the authorities operates at a high standard of integrity, impartiality and proficiency. They are quite general and set the rules of the game on how we will operate in that space. Similarly, the draft Food and Feed Imports (Amendment) (EU Exit) Regulations 2019 will ensure the continuation of existing controls at the UK border, to ensure that imported food and feed of non-animal origin remains safe. DEFRA handles products of animal origin.
With the permission of the shadow Minister, my hon. Friend the Member for Washington and Sunderland West, I will mention that it has occurred to me that the Minister has now made three references to borders. He also referred to progress last night on the deal. Has he had time to digest the changes announced last night and to consider whether there will be any implications on the border on the island of Ireland for the movement of food?
I heard the statement in the House last night and I have read a little bit of it this morning, but I wanted to give every attention to the Committee, as the Opposition Whip will understand. I shall listen closely to the advice of the Attorney General, which I believe is imminent, and to any statements made in the House today.
The imports that I was referring to can contain contaminants, such as salmonella in sesame seeds and pesticide residues in peppers—and in lemons, believe it or not. Imports of those goods from specified countries are currently controlled by Commission regulation 669/2009. Notification about those products must be given in advance of their arrival and they must be subject to official controls ranging from documentary checks to identity and physical examinations, including sampling. To give another example, if I may, Commission regulation 884/2014 lays down controls governing the import of nuts, nut products and some spices from listed countries. Examples of listed countries could be India—I cannot read my own writing—Indonesia or Ethiopia. There is a full list. It is important that these controls and the others listed in the instruments function properly once we leave the EU.
Fundamentally, the amendments specified in these instruments address technical deficiencies in key pieces of European legislation with application to the entire UK and three pieces of domestic legislation that apply in England only. The amendments have been bundled together because they all address law designed to ensure the effectiveness and standards of our official controls system, including for food and feed imports.
Hon. Members will notice that the instruments concern the protection not just of public health, but of animal health and welfare. In particular, the draft Official Controls for Feed, Food and Animal Health and Welfare (Amendment etc.) (EU Exit) Regulations 2019 have been jointly prepared by officials from the Food Standards Agency and DEFRA. However, it was agreed that ultimate responsibility for the instruments would lie with the FSA.
The instruments are intended solely to address inoperabilities in domestic legislation and retained EU law. However, as a result of the way the law is constructed, that results in some changes to the way our legal framework for official controls would work. As some of the amendments address retained EU law, it was necessary to remove references to EU terminology, such as “member states”—that is perfectly logical—and to systems such as the European reference laboratories network. Ultimately, UK competent authorities will no longer participate in European programmes regarding official controls, such as the European Commission’s international audit body, SANTE. That fact is addressed by the amendments and DEFRA is preparing a domestic audit body of its own.
Furthermore, the powers that are currently provided to the European Commission to make legislation are either repatriated to the appropriate UK authority, amended to become administrative functions or removed altogether as a result of their inapplicability—[Interruption.] Yes, exactly—inapplicability. It is my age. I was going to say “as a result of their inapplicability in a UK-only context”. We will edit that bit out. Powers have been transferred strictly where necessary for the UK to maintain a controls system responsive to emerging risks to public health and animal health and welfare.
That is particularly the case in the area of import controls. Although the existing rules governing official controls do not create detailed rules for the performance of controls on imported food and feed, they do set standards and powers for competent authorities controlling trade in such goods. In practice, in the short term this will only mean an increase in the need for more controls on high-risk food and feed, such as the sesame seeds contaminated with salmonella that I referred to earlier, entering the UK from third countries via the European Union. EU regulation 669/2009, which I mentioned, contains the list of those countries, and I can give some examples if hon. Members are interested.
(5 years, 9 months ago)
General CommitteesIt is a pleasure to serve under your chairmanship, Mr Robertson. Here we are again, discussing statutory instruments that would make provision for the regulatory framework after Brexit in the event that we crash out without a deal. That possibility has been known about for nearly two years, since article 50 was triggered, yet this pair of detailed and important draft regulations are being debated only three weeks before the proposed exit date.
The volume and flow of EU exit secondary legislation is deeply troubling in terms of accountability and proper scrutiny. The Government have assured the Opposition that no policy decisions are taken as part of these regulations. However, establishing a regulatory framework inevitably involves matters of judgment and raises questions about resourcing and capacity that I will address in detail later on. It is our view that secondary legislation ought to be used for technical, non-partisan, non-controversial changes, primarily because the legislative accountability process is not suited for anything beyond that. Instead, the Government continue to push through contentious and detailed pieces of legislation with high policy content in this manner.
As legislators, we must get this process right. The regulations could represent real and substantive changes to the statute book. As such, they need proper, in-depth scrutiny. The draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 alone are over 200 pages long. The draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 are just under 200 pages long. They cover several EU directives and cannot possibly even be read in the time we have, let alone debated sensibly. We therefore put on record our deepest concerns that the process for these regulations is not as accessible and transparent as it should be.
Decisions made today could have huge implications for a multi-billion pound industry, potentially affecting millions of patients’ lives. Yet we are presented with non-amendable instruments with a derisory amount of parliamentary time allotted to debate them. People who voted to restore parliamentary sovereignty might feel that this is a long way from what that should look like. I appreciate that this wholly unsatisfactory approach is not down to the Minister. I thank her for introducing the regulations and for the time that she and her officials gave me yesterday to discuss them, but as the representative of the Government seeking to trample all over proper scrutiny, she has the onerous task of defending this approach, although I believe no one can defend this mess.
As we have heard, the UK participates in an EU-wide system for the testing and approval of medicines and medical devices. The regulations transfer responsibility for those activities to the MHRA—a standalone medicines and devices regulator for the UK—in the event of a no-deal Brexit on 29 March. The instruments intend to ensure the continuity and safety of medicines and devices in the UK, while retaining the UK regulator’s ability to take regulatory action to protect public safety. We do not disagree with that objective, which is why we will not oppose the regulations, but that is not to say that we do not have serious concerns about how that objective will be achieved in practice—there are many questions about that.
Although the objectives set out in the instruments are intended to be met with minimum disruption and burden on businesses and the supply of medicines and devices in the UK, we have serious misgivings about how realistic that proposition is.
My hon. Friend mentions minimal disruption to patients, which the Minister mentioned twice. Does he share my concern that any patient listening to or reading the record of these proceedings, who regularly has to take medicine or receives a medical device, will not know whether the minimum disruption may affect them? That may cause significant distress.
My hon. Friend is right; we will all have had constituents raise those real concerns. I will go into more detail about what the Government’s impact assessment says about some of these issues, which justifies our concerns.
Under the draft regulations, the MHRA, which already carries out a wide range of work, including medicines licencing, pharmacovigilance, inspections of standards and enforcement, will take on an expanded role in the registration, assessment and post-market surveillance of medical devices. Listening to the Minister, we could be mistaken for thinking that that massive expansion in responsibility and bureaucracy will take place with no disruption and with no impact on businesses and patients but, as we have just heard, we have real anxieties about that.
The regulations will enable the UK to continue to recognise prescriptions from the EEA. They provide transitional grandfathering rights for medicines and products that have already been authorised in Europe up to exit date, and provisions that would allow the Secretary of State to make temporary changes to the authorisation process or to allow alternative medicines to be dispensed in the case of potential shortages. Their importance cannot be overstated.
As 29 March is fast approaching, the regulations are increasingly crucial. It is right that we make arrangements, although it is a matter of regret that we are dealing with them in this manner at the last minute. We support efforts to ensure regulatory continuity, to ensure the ongoing safety of medicines and medical devices entering the UK market and to avoid disruption to the UK supply chain. But we have several questions about the additional cost to businesses, about the MHRA’s capacity and resources to take on these additional roles and responsibilities, and the Government’s general ill-preparedness to deal with medicine shortages and additional regulations.
Let us start with the impact on businesses. The Government’s own impact assessment for the medicines regulations recognises
“a possibility that some medicines that would have been authorised in the UK because of the UK’s involvement in the EMA will not be submitted to the MHRA due to business decisions. This could have an impact on access to certain medicines and therefore to public health.”
The phrase “business decisions” is, on the face of it, quite innocuous—all businesses make decisions all the time—but the impact assessment almost suggests that such decisions are being made in a bubble, in isolation from the regulatory environment in which they operate.
The impact assessment for the medical devices regulations is a little more explicit. It says:
“It is likely manufacturers would seek to recoup these additional regulatory costs through price increases, which would affect NHS budgeting and spending choices”.
That seems at odds with previous assurances. Indeed, the Minister’s colleague, the Under-Secretary of State for Health and Social Care, the hon. Member for Winchester (Steve Brine), said in a Westminster Hall debate in November 2017 that one of the three key principles for medicines access post-Brexit was that,
“patients should not be disadvantaged”.—[Official Report, 21 November 2017; Vol. 631, c. 349WH.]
Yet that is what we are facing now, and it is a damning indictment of the way the Government have mishandled the entire process.
Has the Minister made an assessment of which specific medicines might not now be submitted to the MHRA? Are any particular conditions or patients more at risk than others? What actions has she taken to speak with businesses and ease their concerns about the decisions they will have to make? What public health impacts has her Department been planning for? What contingency plans are in place? Will she clarify exactly which medicines the Department believes will increase in price and by how much, and what the Department will do to avoid the possibility of those costs being passed on to patients or indeed the taxpayer? Has there been a revised estimate of the annual NHS drugs bill, for example, as a result?
The Government’s impact assessment also recognises that there will be,
“ongoing costs for businesses currently operating in the UK as they would need to adhere to additional UK only regulatory requirements if they currently sell in the EU/EEA. This includes additional fees, legal and administration costs.”
Given that there will also be,
“familiarisation and set up costs as businesses transition into dealing with both systems”,
will the Minister confirm whether the Department will be providing any financial relief to the largely small and medium-sized enterprises that will be affected by the changes? What about the MRHA’s capacity and funding to take on additional roles and responsibilities? The impact assessment recognises that there will be,
“costs to the MHRA of establishing and sustaining new regulatory capabilities”,
although it states that,
“these will be largely recouped through fees.”
In light of those statements, I have a number of questions for the Minister. Will she outline whether the MHRA will receive additional funding to support the work it will have to take on independently of the EMA, or will costs be passed on to businesses and therefore, by extension, to patients and the taxpayer? Will she outline more precisely what costs the MHRA will face and over what time period? How much of those costs will be recouped through fees and how soon will those fees be recouped? Will she confirm whether the Department intends to cover any of the additional costs that will not be recouped through those additional fees?
Can the Minister confirm whether the MHRA will be given additional staffing and funding to establish and sustain its new regulatory capabilities? Is she aware of what the make-up of any additional staff would look like and whether that is already in place? If so, how many new staff have already been hired, what training have they undertaken and who is regulating them? Is there, in fact, a ready-made market of suitably qualified and experienced staff just waiting to go and work for the MHRA? That is a critical point in the light of our general debates on NHS and healthcare shortages.
The new framework will be far from the rosy picture that has been painted in some quarters, but before we even consider the effect of what will happen when we get there, there is a basic point for businesses to consider. If they decide to continue to trade in this country, do they know exactly what it is they need to comply with, and by when? One only needs to look at the commencement dates for these regulations to understand the scale of the task ahead of them. The medical devices regulations alone contain over 10 pages of commencement dates, and they are not set out in a user-friendly way at all.
Here is one example, from proposed new regulation 4B of the Medical Devices Regulations 2002. Sub-paragraph (1) says:
“Part VIII only applies before 26th May 2020 in respect of a device or accessory that is a relevant device for the purposes of Part II or III if the conformity assessment that the person placing it on the market or putting it into service relies on for doing so is the conformity assessment required by Part VIII (rather than by Part II or III).”
Sub-paragraph (3) says:
“Where Part VIII applies—
(a) Part II ceases to apply, apart from regulations 7A and 19 (to the extent that those regulations otherwise apply, for which see regulations 4D(1) to (5) and 4E(4)); and
(b) Part III ceases to apply, apart from regulations 21A and 30(3) to (5) (to the extent that those regulations otherwise apply, for which see regulations 4D(6) and 4E(4)).”
Another example is proposed new regulation 4E of the 2002 regulations, which states:
“(1) Subject to paragraph (3), regulations 91 to 95 do not apply until the date which is 6 months after the date on which the UDI database managed by the European Commission becomes fully functional (a date that the European Commission is required to publish in the Official Journal of the European Union), unless that date (‘the operational date’) is before 26th May 2020.”
Paragraph (3) states:
“(3) Regulation 91(4) only applies in respect of a device to which Part VIII applies, or in respect of an accessory to such a device—
(a) on and after 26th May 2021 (or on and after the operational date if later), in the case of a device classified in accordance with Schedule 9 as—
(i) an implantable device, or an accessory to such a device, or
(ii) a Class III device, or an accessory to such a device;
(b) on and after 26th May 2023 (or on and after the operational date if later), in the case of a device classified in accordance with Schedule 9 as—
(i) a Class IIa device, or an accessory to such a device, or
(ii) a Class IIb device, or an accessory to such a device;
(c) on and after 26th May 2025”.
I could go on. [Hon. Members: “More!”] Okay, I will do a bit more, then. [Interruption.] Hon. Members are regretting that now. Sub-paragraph (d) states:
“(d) on and after the date which is 2 years after the operational date, in the case of a device considered to be a reusable device, or an accessory to such a device, in circumstances where it is required to bear the UDI carrier on the device or accessory itself.”
The proposed new regulation continues:
“(4) If the operational date is before 26th May 2020, regulations 7A and 21A cease to apply on the operational date in respect of a device or accessory to which Part VIII applies because regulation 4B(1) applies.
(5) Subject to paragraph (7), regulations 157 to 160 do not apply until the date which is 6 months after the operational date, unless the operational date is before 26th May 2022.”
I am sure that Members do not want to hear any more of that, so I am not going to read out the rest of the regulations, but there are another four commencement dates in proposed new regulation 4E alone, and they are subject to different exceptions and qualifications. At least another dozen regulations contain similar provisions. The Minister will be relieved to hear that I am not going to ask her to explain all those and how they relate to one another. I am conscious that we have limited time, so we would never be able to do that anyway, but how on earth can any business be expected to understand, adjust to and comply with all those different dates without a massively increased burden upon them? What support will be made available to businesses so they can be confident that they are complying with the rules correctly?
I feel the need to lie down after that, but I am going to continue and look at the specifics of the draft human medicines regulations. That statutory instrument relies on the power in section 8 of the European Union (Withdrawal) Act 2018 to amend the Human Medicines Regulations 2012 and modify the effect of the restated EU regulations to ensure that all aspects of retained EU law in relation to human medicines operate effectively and are not deficient after exit day as a result of the UK’s withdrawal from the EU.
Will the Minister confirm whether the Secretary of State intends to report back to Parliament on any amendments to existing HMRs after exit day? Will she outline the arrangements for collecting data, monitoring the effectiveness of the regulations and regularly reporting? Will she confirm what bodies will be able to scrutinise performance and delivery, and what assessment has been made of their capacity to take on that additional work?
On pharmacovigilance, in the event of no deal, the sharing of common systems and formal exchange and recognition of data submitted for regulatory activities between the UK and EU countries would cease, and the MHRA would have primary responsibility for the conduct and oversight of all pharmacovigilance activities. The Government’s impact assessment recognises that there will be administrative costs to businesses that need to provide that information to the MHRA. Does the Minister intend for the Department to help businesses with those increased costs, and does she have an estimate of what they might be?
On pharmacovigilance information, the draft regulations provide for reporting by the pharmaceutical industry of suspected adverse drug reactions associated with its medicinal products directly to the MHRA database rather than to the current EU database, which is known as the EudraVigilance database. Will the Minister confirm whether, in a no-deal scenario, the UK would be able to access the existing EudraVigilance database, which may be more detailed than the existing MHRA database of pharmacovigilance information?
On serious shortage powers, this contingency legislation enables regulations to be made to modify the application of the Human Medicines Regulations 2012 to deal with serious shortages of medicinal products, which, as we know, is a matter of great public interest. That would replace the regulation-making power in the European Communities Act 1972 for certain limited purposes and would ensure that Government continue to have the power to make temporary changes to the 2012 regulations in a no-deal scenario. That is a clear example of Ministers being given Henry VIII powers over many regulations if they think there is an urgent need because of shortages.
Does the Minister anticipate a doomsday scenario where it will be necessary to use those powers? Or is she saying, “There’s nothing to see here; we don’t anticipate any problems, but we are going to give ourselves these powers anyway”? Will she outline how the process will be handled if there are shortages and what scrutiny will be available for decisions made under it?
The draft regulations introduce a new targeted assessment route to incentivise novel medicines and biosimilars, which currently use one of the routes involved in the European regulatory network to receive a UK marketing authorisation, or MA, in the same timeframe as today. That involves changes to regulation 58 of the Human Medicines Regulations 2012 and to the Medicines (Products for Human Use) (Fees) Regulations 2016, and may also involve the implementation of further non-legislative changes in order to ensure the
“continued competitiveness of the UK market.”
Will the Minister outline what further non-legislative changes the Department intends to implement? Will she outline details of what the new target assessment route will look like in practice? What assessment has the Department made of the impact of introducing the new route, and how does the Minister propose that we will keep in step with, or ahead of, improvements as the EU makes them while we are in the process of exiting and after we exit?
The generics industry expressed concern in response to the Government’s consultation about whether the targeted assessment routes would be made available for generics. In response, the MHRA proposed to review that and work with industry to shorten the timings of UK national licensing of generics. Will the Minister clarify the timeframe for the review and outline any progress made towards its completion?
With regard to “legal presence”, the medical devices regulations ensure that a UK-based marketing authorisation holder, or MAH, and a UK-based qualified person for pharmacovigilance, or QPPV, will need to be in place for all medicines in the UK. Will the Minister outline how many QPPVs are in operation, what their remit is, what support and training they receive and what net funding they receive? Is the Minister confident that the UK-based QPPVs will immediately have the necessary access to safety data systems for medicines? Can she confirm what ongoing communications there will be between QPPVs based in the EU or EEA and new ones based in the UK? Is she concerned that the additional costs for the UK industry of having to establish domestic pharmacovigilance may make the UK less of a priority market?
Transitional provisions require UK MAHs and QPPVs to be in place within 21 months after exit, to allow time for business to comply. That is especially the case for the QPPV, which is a specialist role. Can the Minister outline the process in that 21-month period? The Government’s impact assessment notes that
“there would be a cost to industry in establishing a contact person, MAH and QPPV presence in the UK for those who do not already have a UK presence”.
Those costs include a direct cost to change an MAH to a UK MAH and to establish
“premises, familiarisation and administration for the interim contact person or MAH, and QPPV to comply with the new legal requirements, and labour costs for these representatives.”
Will the Minister confirm whether the Department intends to help to meet those costs, or will businesses, and ultimately patients and taxpayers, again pick up the tab? What safeguards will be in place, and what are the risks of having our own set of MAHs and QPPVs? Will they require their own insurance? Are there minimum levels of liability that they must be insured for? What is the risk of some random individual being set up as an MAH because there are not people with experience and knowledge available to take up the roles in the first place?
The medical devices regulations ensure that existing centrally authorised products that are currently licensed for the UK market through the EMA will continue to be licensed in the UK in a no-deal scenario. The regulations provide for all existing CAP MAs to automatically be converted into UK MAs, and issued with the UK MA number on exit date, unless the MAH indicates that it does not wish its MA to be converted in that manner. Will the Minister confirm what contingency planning she will undertake if an MAH declines to have its MA converted into a UK MA? Can she guarantee that, in such a scenario, patients will not miss out on medicinal products that are CAPs? Can she outline the cost implications for CAPs of having to supply a full set of data? What will she do if an MAH does not provide that data within one year of exit day?
With regard to packaging, the requirements placed on all actors in the UK supply chain from February this year regarding the safety features aspects in the falsified medicines directive will be removed by the human medicines regulations. Furthermore, this instrument ensures that there will be no obligations on the UK supply chain to affix the safety features or scan packs of medicines. In the interests of public safety, the Government have said that they will evaluate the options for a future UK falsified medicines framework, but ending falsified medicines monitoring without replacing it with a similar UK equivalent is a very serious matter that has clear patient safety implications. Quite simply, it will be harder for the UK to monitor fake medicines coming in from non-EU and EU countries. Will the Minister outline how she intends to resolve that matter as a priority?
The human medicines regulations will also introduce into UK law a new authorised activity as part of the existing wholesale dealer licence, enabling the importation of medicinal products from countries on a list. On exit day, that list will comprise all EU and EEA countries, but the list may change over time. Does the Minister not feel that Parliament should have oversight of those lists, or at least an ability to block or make additions or subtractions, particularly as they will allow medicinal imports?
As we have heard, the medical devices regulations also introduce a new RP-I role to allow wholesale dealers to import medicines from the EU and EEA on to the UK market. Can the Minister confirm how many RP-Is she expects there to be? How will they be trained and regulated? Who will they report to? What arrangements will there be for oversight and holding them to account, including taking legal action against them if there is a concern that they are not carrying out their duties effectively? How will complaints in relation to this new role be handled?
Moving on, the human medicines regulations will allow the recognition of prescriptions from an approved list of countries following EU exit. On exit day, the list will comprise all EEA and EU countries. For a prescription to be eligible, the prescriber must be of equivalent professional status to a profession that is eligible to prescribe in the UK. Will the Minister clarify how oversight will be maintained, to ensure that prescribers are indeed of a professional status equivalent to a profession that is eligible to prescribe in the UK? What will the arrangements be for collecting data and monitoring the effectiveness of these regulations, and how will errors be compensated?
Coming back to medicines, in the event of a no-deal Brexit, there are two possible scenarios for manufacturers marketing biological medicines in the UK. First, where the UK agrees with one or more countries to accept each other’s independent test certificates for biological medicines, it would mean little change from the current arrangements, except as agreed and set out in a formal mutual recognition agreement between the countries. What progress has the Minister made in drawing up the list of those countries with which the UK has an agreement in place, and how many countries does she anticipate the UK will have an agreement with by exit day, whenever that is?
Secondly, where there is no mutual recognition agreement in place, that scenario would involve the National Institute for Biological Standards and Control issuing UK certificates for batches of biological medicines used in this country. Where the batch is destined for use in both the UK and another country, if it has already received independent certification in a country that is on the UK’s approved country list, the NIBSC will take a public health risk-based approach to deciding whether to rely on a paper assessment of that certificate or to issue a UK certificate to carry out testing.
Will the Minister clarify what is meant by a public health risk-based approach in this context? Can she confirm whether the NIBSC has drawn up a clear set of guidelines by which staff will be making those decisions? If so, is she aware of whether staff have received suitable training in using those guidelines, and will she confirm whether the NIBSC is being given extra resources to manage the extra workload that that will require? Can she guarantee that there will be no time lag in making approvals after exit day?
Looking at the sale of medicines, we see that EU-based online sellers currently have to register, comply with relevant requirements and display an EU common logo linked to the competent authority in which they are based. These regulations remove the requirement for UK-based online sellers. Does the Minister not agree that removing that requirement for UK-based online sellers might make it harder to work out which sellers of medicines online are legitimate?
With regard to manufacturing and wholesale dealing, the current good manufacturing practice directive is preserved, with modifications to reflect the fact that the UK is no longer a member state, but with a regulation-making power for Ministers to modify the directive or replace it in the future. The power is also placed on the licensing authority to publish guidelines on good manufacturing practice and good distribution practice, while preserving the EU guidance in place immediately before exit day until it does so. Can the Minister confirm today that these guidelines will be ready on exit day?
I feel I need to sit down, but I have a few further concerns.
My hon. Friend is attacking the detail of these statutory instruments with forensic attention, and I do not envy the Minister in trying to respond to all his many pertinent questions. Does he agree that his analysis of these draft instruments shows that we have been, at best, misled about how straightforward, simple and easy it would be to translate EU regulations, directives and laws into UK law, and also how easy it would be to scrutinise that process? It is important that hon. Members such as him undertake such scrutiny.
I thank my hon. Friend for that helpful intervention. I feel that we could be a double act on the stage, but I am not sure that we would get many people in to watch us talking about these draft regulations. However, she makes a valid point. We have a lot of these problems because of the foolhardy decision to come out of the European Medicines Agency, which has created an unnecessary amount of work. There are serious questions to answer for those who portrayed leaving the EU as a straightforward matter, and who must now justify our having to interpret, debate and agree this absolute minefield of regulations at very short notice.
I will now talk a little about medical devices. You will be pleased to know that I do not have that much more to say, Mr Robertson; I am sure that the Minister is quite pleased about that as well. I will not go over the section 8 powers of the EU withdrawal Act, but they also apply to the draft medical devices regulations and modify the effects of the re-stated EU regulations, so the questions about reporting to Parliament, oversight and the collection and monitoring of data apply in that context, too.
I also have concerns about the conformity of devices, the expansion of registration requirements and data exchange. The Government announced their intention to continue to recognise, for a time-limited period, the CE mark on medical devices and in-vitro diagnostic devices that have demonstrated their conformity with EU regulatory requirements. Will the Minister clarify what is meant by a “time-limited period”, and what the arrangements will be once that period comes to an end? Will she also outline what assessment she has made of the impact of that on access to new devices?
Furthermore, in the event of no deal, UK-based notified bodies responsible for verifying medical devices will no longer be recognised by the EU, meaning that the devices that they have certified will no longer conform to the applicable EU directives after 29 March. What assessment has the Minister made of the impact of not being able to place those products on the market, and what are the Government’s contingency plans for that? While UK law will give UK-based notified bodies an ongoing legal status and will continue to recognise the validity of the certificates that they issued prior to 29 March 2019, those bodies will be unable to issue certificates for new products. What assessment has the Minister made of the impact of that on products being developed for the UK market?
With regard to registration requirements, in a no-deal scenario, all medical devices will need to be registered with the MHRA prior to being placed on the UK market. Where a device manufacturer is not established in the UK, the registration of a product with the MHRA will be undertaken by a “UK responsible person”, who will be established in the UK with a UK-registered address. That person, as the name suggests, will take responsibility for the product in the UK. Will the Minister confirm how many manufacturers will need to establish a UK responsible person? Will she also clarify the oversight and regulation arrangements for such persons? I note that the impact assessment says that it is uncertain how many people will have the necessary expertise to fulfil that role. Does the Minister have a plan for if enough suitable people do not come forward to be a responsible person?
The draft devices regulations also refer to an appropriate transitional period for people placing medical devices and IVDs on the UK market to comply with the new requirements. The transitional period will vary from between four and 12 months, depending on the risk category of the devices. Will the Minster clarify what the arrangements will be when that transition period comes to an end?
Regulations 76 to 133 of the draft human medicines regulations place a large number of obligations on manufacturers, and corresponding powers to the Secretary of State to require compliance. Who, in reality, will perform that role, and what additional resources will they be given to ensure compliance?
Finally, in a no-deal scenario, the UK will no longer have access to EU data systems, including Eudamed, the European databank on medical devices. These systems are vital for data exchange, facilitating the exchange of information between notified bodies, national competent authorities and the European Commission. The MHRA is building an electronic system that expands on the current registrations database, which the Government say will mirror, as far as possible, the Eudamed requirements. Will the Minister confirm that the new electronic system being built by the MHRA will be operational by exit day? What are the additional costs and where is the funding coming from? Will she outline which aspects of the new database will not mirror Eudamed, and what steps are being taken to mitigate that?
Members will be pleased to hear that I have come to the end of my contribution. I appreciate that I have raised a significant number of questions, and it may not be possible for the Minister to answer them all in the time we have, particularly as we also have to hear from the SNP spokesperson, the hon. Member for Central Ayrshire. The amount of material I have gone through today demonstrates without question why this process is so wholly inadequate for dealing with such important and complicated issues. There are many important questions about the impact on businesses, patients and the taxpayer. We really deserve a better attempt at this than that we have seen today.
(5 years, 11 months ago)
Westminster HallWestminster Hall is an alternative Chamber for MPs to hold debates, named after the adjoining Westminster Hall.
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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It is a pleasure to serve with you in the Chair, Mr Howarth. I thank my hon. Friend the Member for Poplar and Limehouse (Jim Fitzpatrick) and other hon. Members for their contributions.
I will focus on cancer affecting children, teenagers and young adults. As hon. Members know, I have personal experience of breast cancer, but more expert people in the Chamber will talk about that, so I will discuss the form of cancer for which I recently set up the all-party parliamentary group on children, teenagers and young adults with cancer.
I set up the group because each year in the UK, 4,450 children and young people under 25 are diagnosed with cancer—that is 12 children and young people every day somewhere in the UK. Four out of five of them will survive for five years or more, but for the parent of a child such a survival rate seems minuscule. Most of us expect our children to survive far longer than that, so the survival rate can seem quite hard. Those of us who have had adult cancer might think, “Oh good—five years! I’ll still be around in five years’ time.” For adults, that feels like a success; for children, not so much.
Cancer remains the biggest killer by disease of children and young people under 25 in the UK. That is important, because one of the reasons why cancer is the biggest killer is that other diseases have declined. That is a good thing, but cancers still affect many children. We want the incidence to decrease, and the number of children surviving and being diagnosed earlier to increase. The all-party parliamentary group wants things to be better. The Minister knows that, because he has been good to the group and worked closely with us. We understand that the small number of children affected can make it difficult to identify real specifics that could make a big difference, but because the number is small, some of the things that we want might be relatively straightforward to do.
Last year, we held an inquiry into young people’s experience of childhood and young adult cancer. We now call on the Government and the NHS long-term plan to look at the impact of a young person’s route to diagnosis. Recent research by CLIC Sargent found that more than half of young people had to visit their GP at least three times before their cancer diagnosis. Katie, the young woman who was a panel member in our inquiry, said that because childhood and young people’s cancer is so rare, GPs did not expect to see it, so frequently signs and symptoms were misunderstood. I have the greatest sympathy for GPs and clinicians, and because those cancers are so rare, we would like a training and e-learning module for healthcare professionals.
CLIC Sargent and the Teenage Cancer Trust have teamed up to create such a module on the signs of cancer in children and young people, developed in partnership with the Royal College of GPs. We would like more support in the NHS workforce to improve recognition of the signs, whether that is the e-learning module or something different. I hope the Minister will say something about that when he sums up. In the NHS long-term plan published yesterday I was really pleased to see a specific mention of childhood cancer, but I was disappointed that there was not more emphasis on skilling up the healthcare workforce to recognise the signs and symptoms. We all know that often the consequence of failing to make an early diagnosis is a very poor survival rate.
In our inquiry we recommended many measures, which the Minister has very kindly agreed to go through with his officials and respond to in some detail. Perhaps after the debate, will he liaise with my office about a time to meet? I am grateful to him for his willingness to do that, but we would like to make some progress in the first half of this year. Some of our recommendations are relevant to this debate. We say that the Secretary of State for Education should ensure that every young person receives health education that includes cancer signs and symptoms, done in an appropriate way. The Teenage Cancer Trust has developed an education module, which many of us will have seen recently when it was demonstrated in Parliament. I would like to see something such as that being used.
The hon. Lady makes an excellent case for education. As co-chair of the all-party parliamentary group on breast cancer, I want to raise the fact that about 3,500 breast cancers go undetected each year due to women not understanding the risk due to breast density. Education would seem critical as part of the long-term plan to get world-class outcomes, so that people understand their personal risk.
The hon. Gentleman is absolutely right; education is critical across all cancers, particularly breast cancer. Many young women need more under- standing of how their risk can be reduced by certain lifestyle choices. I say that carefully, without wishing to blame cancer survivors, because there is a difficult balance. Education is important, because the health service we want for the 21st century is about health rather than sickness. I wanted to see more emphasis in the NHS long-term plan on prevention.
Will the Minister respond to some of our recommendations in his reply to the debate? The all-party group thinks that an emphasis on prevention is critical to young people’s long-term survival and long-term health—not long-term sickness. We are concerned about the shortage of radiographers and radiologists, but other Members will discuss that. If more children and young people with cancer are to survive longer than five years, early diagnosis is critical. Health professionals may see only one childhood cancer in their entire professional life, so they will need help. I ask the Minister to talk to us and to his officials about how to help the professionals to do better. We would like more education for young people on a range of cancer indicators and on ways to change their lifestyle, such as exercising more, reducing alcohol consumption and so on. We all know about those actions, but quite often it is too late; we could do with knowing them from an early age and building them into our way of life, starting when we are young.
I want to conclude, without getting too emotional, by paying tribute to CLIC Sargent and to the Teenage Cancer Trust in particular. They do so much, not just for children and young people but for parents and families. Members of my family received help from CLIC Sargent. My dear sister-in-law works for CLIC Sargent and she has been an inspiration to me on childhood cancer. I want the work they have done to be embraced by Ministers other than this Minister, who already has embraced it, to take that forward in the NHS long-term plan.