Infant First Aid Training for Parents

Jackie Doyle-Price Excerpts

Wednesday 3rd April 2019 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

I join all colleagues in thanking my hon. Friend the Member for Truro and Falmouth (Sarah Newton) for bringing this important subject forward for debate. She has brought to it her characteristic good sense and made her case extremely well. I join colleagues in paying tribute to her work as a Minister. I must say that I had to work with her regularly when she was Minister for Disabled People and I miss her terribly, but if today is anything to go by, I am sure she will keep me busy from her position on the Back Benches, and I thank her for that.

I thank all hon. Members who have participated today, particularly my hon. Friend the Member for Moray (Douglas Ross), who brought his perspective as a new parent. If he will forgive my saying so, as he was articulating some of the things he learned, it brought home to me how new parents can be a bit like rabbits caught in headlights, thinking, “Oh my goodness, I’ve got this fragile thing, what am I to do?” Again, that brings home the need for parents to feel confident in looking after their newborns.

My hon. Friend the Member for Sleaford and North Hykeham (Dr Johnson) gave a forensic exposition of the risks children face, and reminded us that we are equipping people with good, common-sense practical skills for things that can happen to anybody. She made her arguments extremely well. It is always a pleasure to listen to the hon. Member for Glasgow East (David Linden); again, he brought the subject to life beautifully with his own experience and spoke excellent common sense.

I am surprised to hear that the hon. Member for Burnley (Julie Cooper) is a grandmother, but that probably explains why she speaks from such a well-informed perspective. I am glad that she shared Leanne’s story, because it was a perfect example of how going through a course made that parent feel confident about how to deal with a child in distress, and helped her to understand exactly what the condition in front of her was.

Faced with such evidence, we can only do more to spread the news to parents that it is a good idea to equip themselves with first aid skills. From an NHS perspective, as the hon. Lady mentioned, if parents know more about their children’s conditions, there will be fewer visits to A&E and fewer visits to GPs, and that will make the NHS more effective. In a sense, what is not to like?

There are many providers of such products in the market. We have heard about St John Ambulance, the Red Cross and other local providers, and I would not want to favour one or other of them, beyond highlighting that those courses are available, as well as material on the NHS app. I hear what the hon. Lady says—that that is no substitute—but I tend to see these things as complementary. Today’s new parents are of the smartphone generation and want to access material via apps, and we must ensure that we have a good spread of information available to parents.

The death of any child is a tragedy, and the more we can do to support people to be the best possible parents, the better, because it is vital to the longer-term outcomes for the health and life chances of their children. I know my hon. Friend the Member for Truro and Falmouth brought her experience from her campaign to raise awareness of sepsis, which she referred to in her speech. Sepsis is a silent killer, and probably one of the most preventable causes of death, if we can identify it quickly enough. It is important that we continue to raise awareness so that people, and particularly parents, can spot the signs of sepsis and make decisions and interventions that will help sufferers.

Reference has been made to where we have these interventions and who can give new parents advice on first aid. I see midwives and health visitors as being on the frontline of doing that. My hon. Friend the Member for Moray explained that antenatal period when we are building a relationship and lapping up the information. The trust parents have in midwives and health visitors is a special relationship and presents a powerful opportunity for us to make an intervention to improve health outcomes for all. I see them as the cornerstone of ensuring that parents have the knowledge and skills they need before, during and after their baby’s birth, and that they have access to all the information they need.

There is information on the NHS website with tips for new parents, including information on the signs of a serious illness in a baby or toddler, but it is important that health visitors talk through common conditions with parents. It is a question of confidence; it is about making parents feel confident that they know what is happening to their child and that they can do their best to help them.

That was brought home by the account my hon. Friend the Member for Truro and Falmouth gave of Rowena’s story and the fact that Rowena felt able to take someone’s child and help them because she had had that grounding. Such things can obviously go the other way, and none of us wants to be in the position of thinking, “What if?” or, “If only”. There is clearly every reason to encourage as widespread training in first aid as is possible.

My hon. Friend has a simple ask: she wishes the Government to fund a pilot project to generate evidence for a further roll-out of the project she has witnessed locally in Cornwall. The National Institute for Health Research welcomes funding applications for research into any aspect of human health, and any application will of course be judged in the normal way. Awards are made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality, so I encourage her and the team she is working with to apply for such a grant so that we can, as she says, demonstrate that the training has an impact on outcomes and provides better value for money for the NHS. It seems to me to speak for itself, but I encourage her to go through that process.

[Julie Cooper]

Can the Minister assure us that, if funding is achieved for such a pilot and the training is shown to be beneficial, the Government will commit to universal provision?

[Jackie Doyle-Price]

That will come down to the evidence base. The hon. Lady raised some questions about prevention in her speech. Following the long-term plan, we are working up our wider proposals for prevention, and we see interventions in the early years and childhood as extremely important, so we will look at what measures we need to take in that context. At this stage, I am not able to commit to universal provision of a particular product, but we need to look at how we can best equip parents with the tools to look after their children as well as they possibly can.

Every parent wants their child to stay safe. Frankly, my hon. Friend the Member for Sleaford and North Hykeham scared me to death with the risks she highlighted, because they illustrate just how easily any one of us could fall victim to an accident, and for a child that is especially the case. We know that unintentional injuries are one of the main causes of premature death and illness for children in England. To put a figure on that, every year in England 55 children under the age of five die from injuries in and around the home, which is 7% of all deaths of children aged one to four. That is pretty stark. We can factor on to that the 370,000 visits to A&E departments and 40,000 emergency hospital admissions in England each year because of accidents at home among under-fives.

Preventing accidents is part of Public Health England’s priority of giving children and young people the best start in life, and is an area to focus on. I was struck by the reference to choking, because that is a situation where knowing what we are doing can be the difference between life and death; by the time an ambulance has been called, it will be too late. There is much more that we need to do to educate people on how to deal with a child who is choking, because it is something that can happen to any child. We have all seen children excited and gobbling their food down, and with that obviously comes the attendant risk.

As I mentioned, health visitors are accessible to all parents and provide a trusted source of knowledge, advice and information. I want to make sure that we take full advantage of health visitors in that space. Through our work on early years, we are looking at what more we can do to support them, to make the most of that intervention. I am confident that if we make better use of that workforce, we can take a lot of action in this area, not least because parents find engaging with their health visitor less intimidating than they perhaps find medical professionals or anyone else; it is a relationship built up in the home. Health visitors are also the part of the scheme that deals not only with mum but with dad and the rest of the family as well, which is so important. Health visitors lead and support the delivery of preventive programmes for infants and children from nought to five years old through the healthy child programme, including by giving regular advice on accident prevention and links to wider community resources.

[Julie Cooper]

Does that mean that the Minister is committed to restoring the number of health visitors?

[Jackie Doyle-Price]

The hon. Lady will be aware that there has been a fall in the number of health visitors, following a peak in 2015. I am extremely committed to making sure that we have an ample supply of health visitors, because they are on the frontline of early intervention; they are an army. She will know that the NHS long-term plan, recognising that local authorities have borne the brunt of fiscal discipline in this area, explicitly says that we will strengthen the relationship between the NHS and local authorities in this space, because that is clearly good for health outcomes. I hope that that reassures the hon. Lady.

I could go on for much longer, Mr Hollobone, but I do not want to stretch your indulgence unduly. I thank my hon. Friend the Member for Truro and Falmouth for all her work on this matter and on raising awareness of sepsis. We will continue to co-operate in this area. I can tell her that Public Health England very much has this area on its radar, in terms of giving advice to parents on how best to look after their children. We will continue to work with the Royal College of Paediatrics and Child Health to establish a single, England-wide paediatric early warning system to improve the recognition and response of healthcare services to deteriorating children or young people across England in primary and community care, including in the ambulance service and hospitals. Information and advice to help parents recognise and respond to signs and symptoms of ill health are freely available.

We must continue to champion and promote this cause. I thank midwives and health visitors for their tremendous work—they play such an important role in this—as well as providers of first aid courses. I look forward to engaging with my hon. Friend further on this matter.

NHS Pension Scheme: Tapered Annual Allowance

Jackie Doyle-Price Excerpts

Tuesday 2nd April 2019 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

It is a pleasure to serve under your chairmanship, Sir Roger. I thank my hon. Friend the Member for East Renfrewshire (Paul Masterton) for securing the debate; he made a characteristically thoughtful contribution.

We are the custodians of taxpayers’ money and need to manage the country’s finances in a way that gives value for money and allows us to live within our means. We also need to accept that when we make changes to the tax system, it changes people’s behaviour. I am grateful for the opportunity to look at these issues through the prism of the impact on the workforce in the national health service.

As my hon. Friend said, the annual allowance is a fiscal measure that operates across all pension schemes in both the public and private sectors. Alongside the lifetime allowance, the Government keep this measure under review to ensure that the benefit of tax relief on pension scheme contributions remains affordable. It is in fact one of the most expensive tax reliefs in the personal tax system. In 2015-16, income tax relief and employer national insurance contributions relief cost the Exchequer around £50 billion, with around two thirds going to higher-rate taxpayers. That is an important point to bear in mind, because we need to ensure that our tax system is progressive and managed efficiently. We will want to look at tax reliefs that favour the highest-rate taxpayers to ensure that our overall burden of tax is appropriate.

The reforms made to the lifetime and annual allowances in the previous two Parliaments are expected to save over £6 billion a year, and are necessary to deliver a fair system and to protect public finances. To ensure that the benefit the wealthiest pension savers receive is not disproportionate to that of other pension savers, the Government restrict the amount of tax relief available. The annual allowance does not taper below £10,000, and fewer than 1% of pension savers will have to reduce their saving or face an annual allowance charge because of this policy.

[Julian Knight]

Does the Minister agree that a potential issue is that this acts as a cap on the amount of tax relief that is given out? We know that this is not progressive in terms of higher-rate tax relief on pensions. Would it not be better for us to look at a system in which we have a flat rate of 25p, 28p or 30p in the pound, rather than the higher rate? That would mitigate, or mean that we did not need, those lifetime and annual allowances?

[Jackie Doyle-Price]

I shall not stray into policy that is not mine and that belongs to Her Majesty’s Treasury—that is a very convenient way for me to duck the issue. It comes back to the point that the moment we start to introduce complexity into our tax and allowance system, it brings perverse incentives. The overall goal in recent years has been to bring our public finances back into kilter, having had excessive deficits. It is only natural that the Exchequer looks at where reliefs that are funded by the state are going to higher-rate taxpayers. That is where we have got to with regard to the impact on public sector pension schemes, which by their nature are as we describe.

The NHS pension scheme is a generous and valuable part of staff reward packages, and is one of the best schemes available, notwithstanding the issues raised by my hon. Friend the Member for East Renfrewshire. It is right and proper for all hard-working NHS staff to expect financial security in retirement after dedicating a lifelong career to looking after the nation’s health.

For some senior clinicians, the generosity of the scheme, combined with their comparatively high levels of pay, means that their pensions build up to a level that breaches tax limits. Both the annual and lifetime allowances encourage pension growth at a steadier rate that is more aligned with typical pension growth experienced across the general population. To illustrate that, under the 1995 section of the NHS pension scheme, members who accumulate pension benefits worth near the £1 million lifetime allowance will have built up a pension of around £46,000 a year, plus a tax-free lump sum of £138,000 on retirement. Pensions of that size provide substantial financial security in retirement, and it is right that the Government take steps to limit the tax incentive to save further.

My hon. Friend raised concerns about the impact on our NHS workforce. With respect to discussions between the Treasury and the Department on the introduction of the allowance, the 2015 manifesto committed to

“reducing the tax relief on pension contributions for people earning more than £150,000.”

That was a manifesto commitment we had to deliver. The tapered annual allowance fulfils that commitment and applies to all contributors to pensions, in both the public and private sectors. The impacts of the change, including on the public sector, were carefully considered at the time.

My hon. Friend asked about the number of doctors and dentists taking early retirement. Data from the NHS pension scheme administrator shows that 494, 490 and 424 hospital doctors took voluntary early retirement in the financial years ending 2016, 2017 and 2018 respectively. Those early retirements represented approximately a third of all hospital doctor retirements in those years. With respect to GPs, in 2016, 695 took early retirement; in 2017, 721 took early retirement; and in 2018, 588 took early retirement. Those figures represented more than half of all GP retirements in those financial years. With respect to dentists, 145 retired early in 2016, followed by 143 and 115 in 2017 and 2018 respectively. Those retirements represented approximately 40% of dental practitioner retirements in those years. There is clearly an impact on the behaviour of practitioners.

My hon. Friend asked what consideration the Treasury has given to a general review of the annual allowance taper and the broader system of reliefs in relation to pension saving. Those are matters for the Chancellor, and the Government will continue to review all aspects of pensions policy, in line with our annual assessment of the public finances.

[Jonathan Edwards]

I am grateful to the Minister for giving way. She is highlighting some of the concerns that have been expressed about the unintended consequence of a capacity problem for the NHS as a result of the changes to pension relief. Given that health is a devolved issue in Wales, have the British Government received any communication from the Welsh Government expressing concern about the changes?

[Jackie Doyle-Price]

I have not, but this is about the impact of the pension and tax regime on the sector. I am not aware of any conversations with the Treasury, but if the hon. Gentleman has concerns, I encourage him to make representations. There are always unintended consequences with any policy, and we always need to challenge the operation of our policies to make sure they are in the right place and to decide whether they need to be refined, tweaked or changed in any way.

The Government recognise that pension tax considerations will contribute to decisions by some senior clinicians to retire early or to reduce their NHS commitments. For those who wish to remain in the NHS pension scheme, the annual allowance is a disincentive to take on additional work and responsibilities —that is very clear. The extra income increases the impact of the tapered annual allowance.

Some clinicians may judge that a reduction in their current NHS commitments, while maintaining scheme membership, better serves their financial interests. Employers tell us that the reduction in service capacity can be difficult and that capacity is expensive to replace. I assure my hon. Friend that the Government are listening carefully to the concerns raised by senior doctors and NHS employers about the impact of the tapered annual allowance.

That doctors may seek to limit or reduce their NHS commitments is of concern to Ministers, and something on which we are keeping a close eye. Maximising the participation of our clinical workforce is clearly essential to the delivery of our ambitions for the NHS. The quality and quantity of our workforce is always an important factor in the extent of the delivery of our objectives.

As an immediate step, the Department has sought to make available to NHS pension scheme members all possible flexibility under Her Majesty’s Revenue and Customs legislation and the current fiscal framework for public sector pension schemes. The BMA asked that we extend the scope of the voluntary “scheme pays” facility—implemented by the NHS pension scheme—to cover the payment of tax charges from breaches of the tapered annual allowance.

We have done that, but we have also gone further. The NHS pension scheme’s voluntary “scheme pays” facility has also been extended to cover tax charges of less than £2,000, which means that, from tax year 2017-18, a member can elect for the scheme to pay 100% of their annual allowance charge to HMRC on their behalf. The “scheme pays” facility allows individuals to settle their tax charge without needing to find funds up front, but HMRC requires an adjustment to the benefits accrued by members if a defined benefit pension scheme pays an annual allowance charge. That adjustment must be just and reasonable, and with regard to normal actuarial practice.

Accordingly, the NHS pension scheme applies an interest rate to the charge paid on the member’s behalf. That charge is deducted from the capitalised value of the pension at retirement, with the interest rate set at the scheme discount rate. I recognise that, for some younger clinicians with many years before retirement, the compounding effect might influence the attractiveness of “scheme pays”, so I encourage members of the pension scheme to seek formal financial advice.

The Government will look at potential further measures. There is clearly considerable interest in this matter, and I assure hon. Members that we keep the impact of public sector pay and pensions policies under constant review, and take account of total reward and fiscal considerations. As my hon. Friend recognises, the issue is complex, and it is difficult for the Government to strike the right balance among competing interests. I do not think, however, that there is a case for exempting high-earning NHS staff, such as GPs and consultants, from a tax measure that is intended to apply to high-earning individuals. I also doubt that clinicians necessarily expect to be treated differently from other taxpayers.

The fiscal framework within which the NHS pension scheme operates is an important consideration. The NHS pension scheme, like most public service pension schemes, does not manage a fund of assets out of which pensions are paid. It is instead financed on a pay-as-you-go basis similar to that of the state pension, with contribution income defraying the cost of pensions in payment. Any change to scheme rules that provides flexibility could therefore have a significant effect on contribution income. That would have an impact on the Exchequer. We must balance that fiscal risk against the benefits of providing additional flexibility. Any proposed pension flexibility would be a matter for the Chancellor.

Clearly, this is a complex subject that we will have to keep under review in recognition of the fact that it drives behaviour in the NHS in a way that could cause us difficulties in the delivery of our overall commitments. We clearly want to retain the best, most qualified and expert staff in the NHS, and we need to be vigilant to ensure that our tax and pension benefits system does not stand in the way of delivering the best possible NHS.

Question put and agreed to.

Pancreatic Cancer

Jackie Doyle-Price Excerpts

Tuesday 2nd April 2019 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

It is a pleasure to serve under your chairmanship, Mr Hollobone. I thank the hon. Member for Scunthorpe (Nic Dakin) for the articulate and passionate way in which he made his case. He has a long history of campaigning on this issue, and long may he continue. We know that we need a conscience when it comes to driving improvements throughout the health system, and it is always instructive to hear people’s experiences. I thank the hon. Gentleman for all the work that he does in chairing the all-party parliamentary groups on cancer and on pancreatic cancer.

I am very grateful to the hon. Gentleman for sharing the stories of Ali Stunt, Maggie Watts and Erika Vincent, because we need to remember that we are not talking about some vague disease that happens to other people; it happens to real human beings and their lives are incredibly affected by our failure, or otherwise, to take action in these spheres. They also inspire us. The fact that Erika Vincent dedicated so much of her final days to raising awareness is inspirational, and we would be very poor if we did not take action following that.

I also thank the hon. Member for South Shields (Mrs Lewell-Buck) for sharing her family story. Again, she illustrated that this can happen to any one of us. When we are in a position to do something about it, we must act.

No one will be surprised that tackling cancer is a major priority for the Government. We have presided over year-on-year increases in survival rates, so that today they are at the highest levels recorded. However, we should not rest on our laurels and be complacent. That is good progress, but we must do better—our ambition is to do better.

Last October, the Prime Minister announced a package of measures with the aim of detecting three quarters of all cancers at stages 1 or 2 by 2028. These measures will see improvements to our screening programmes and new investment in state of the art technology, to further improve diagnosis and boost long-term research and innovation.

That represents the cancer element of the NHS long-term plan, published in January, which sets out how we will achieve our ambition of 55,000 more people surviving cancer for five years in each year from 2028. Colleagues will be aware that the Secretary of State is placing considerable emphasis on prevention, so we need to look at what else we are doing, in terms of screening and research, to tackle these issues. All of that is to be commended, but we must not be complacent. We can learn from the examples of Belgium and the USA, where much greater advances have been made.

The hon. Member for Scunthorpe reminds us all that survival rates for certain cancers remain stubbornly low, including for pancreatic cancer, which is the least survivable of all cancers and so merits special attention. As he alluded to, late diagnosis is a key reason for that. We know that less than a quarter of people have their cancer diagnosed at stage 1 or 2, compared to half of people for all other cancers.

The new early diagnosis ambition represents a huge opportunity to change that for three reasons. First, the ambition must apply to all stageable cancers, including pancreatic cancer. NHS England is working with Pancreatic Cancer UK and others on how we can adjust the current national measure of early diagnosis to include pancreatic cancer for the first time.

Secondly, within that headline measure, the Government are committed to publishing regular data on individual cancers. We need to be transparent about how we are performing in this area, so that we can identify which cancers we are tackling in terms of early diagnosis, and which need more attention. That will provide a powerful catalyst for all the charities to come together and work with NHS England to deliver that change.

[Nic Dakin]

I thank the Minister for the serious and thoughtful way in which she is responding to the debate. Does she think that there is an opportunity to look at a 20-day target for moving from diagnosis to treatment, which would make a real difference to this cancer?

[Jackie Doyle-Price]

Indeed. I will come to that point, if the hon. Gentleman bears with me.

I would like to highlight the other unsurvivable cancers that suffer from late diagnosis, which, as well as pancreatic cancer, include cancer of the stomach and oesophagus. We must ensure that we also focus on those cancers.

The focus of the hon. Gentleman’s speech was that pancreatic cancer should be treated as a cancer emergency. Pancreatic Cancer UK’s recent demand for faster treatment set the ambition to treat pancreatic cancer within 20 days from diagnosis by 2024. The hon. Gentleman mentioned Liz Oakley. The fact that she had treatment within 12 days shows that it can be done. We should embrace that level of ambition. While we recognise that great achievement and advance, we should ensure that that is the experience across our national health service.

What I will say does not quite meet the hon. Gentleman’s request, but I think he will welcome the direction of travel. NHS England will shortly be introducing a faster diagnostic standard of 28 days for all cancer patients, including those with pancreatic cancer. That will mean that every patient can expect a definitive diagnosis—yes or no—within 28 days. Taken together with the 62-day referral to treatment standard, all patients should expect to start their treatment within 34 days of diagnosis.

I know that is not quite the target that the hon. Gentleman set me, but if we can ensure the whole system works to that efficiency, we will make great strides in tackling this. I cannot emphasise enough that we should never lack ambition in how far we are prepared to drive improvements. That standard of treatment within 34 days is the maximum, but I expect trusts always to treat patients according to clinical need and to prioritise those needing urgent treatment, such as Liz Oakley, who received treatment within 12 days.

We welcome Pancreatic Cancer UK and all other stakeholders working with the pancreatic cancer clinical community to develop practices to shorten the time before treatment even further. It is important that we continue that dialogue, not just to be reactive, but to build confidence, because poor survival rates are well understood. We do not want people to be diagnosed and automatically think that there is no hope. There is always hope, and our NHS services must ensure that people understand that.

NHS services for pancreatic cancer have improved significantly in recent years. I am grateful that the hon. Gentleman accepted that. In the spirit of demanding more, it is always good to look at how far we have come. I thank him for that. There are now clearer diagnostic pathways. Decision making is done by specialist multi-disciplinary teams.

--- Later in debate ---

[Jackie Doyle-Price]

I will try to remember where I left off.

Obviously, cancer treatment plays a big part in our long-term plan for the next 10 years, which sets out positive developments at every stage of the pancreatic cancer pathway. Clearly, we need to look at issues such as prevention, as we have mentioned, but the plan also signals a shift towards more risk-based approaches to screening. We will begin to test family members of cancer patients where they are at increased risk. Data suggests that 10% of pancreatic cancer cases are inherited, so screening can be a big tool with which to combat the disease.

Primary care networks will play an important new role in supporting GPs to build on the doubling in referral volumes that we have seen since 2010. Rapid diagnostic centres will provide a new referral route for patients, particularly those who go to their GP with vague symptoms, and will ensure that they get checked out quickly and accurately. From next year, many more newly diagnosed cancer patients will be offered genomic testing to help to inform their treatment planning. We will continue to invest in safer and more precise treatments, including immunotherapies, to improve survival rates. We are completing a massive upgrade of radiotherapy services across England, which will increase the support that patients can access. Finally, the plan reaffirms our commitment that every person diagnosed with cancer will have access to personalised care, including a needs assessment, a care plan and health and wellbeing support.

I will quickly say something about research. In 2017, Pancreatic Cancer UK and four other charities launched the less survivable cancers taskforce, which represents all cancers with stubbornly poor survival rates and calls for improvements in research. My hon. Friend the Member for Winchester (Steve Brine) spoke at the taskforce’s launch and put the Government’s full support behind it. Research into innovative medicines and treatments is extremely important. We accept that there is an unacceptable research funding gap, with less survivable cancers receiving five times less research funding than more survivable cancers, which we need to address. Cancer Research UK has prioritised increasing research into hard-to-treat cancers, including pancreatic cancer, but more needs to be done.

In closing, I reiterate that, as a Government, we have made considerable progress, but there is much more to be done. I am grateful to the hon. Member for Scunthorpe and all hon. Members who have taken an interest in the debate. I know that they will hold the Government’s feet to the fire to ensure that we carry on making real improvements in treating and supporting people with pancreatic cancer.

Question put and agreed to.

Resolved,

That this House has considered treatment for pancreatic cancer.

Bereavement Counselling

Jackie Doyle-Price Excerpts

Tuesday 26th March 2019 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

Thank you for allowing this debate, Mr Speaker. I am really glad to have this opportunity to respond to my hon. Friend the Member for Boston and Skegness (Matt Warman), who has spoken incredibly movingly about his personal experience. In this place, it is difficult to speak rawly from the heart, but he has done well today. He has done extremely well. His speech sets in stark relief the fact that we are all human beings in this place, although people might be forgiven for thinking otherwise in recent days. We all bring our own experiences here, and it takes a lot of courage to share some of them. I am not always as confident and brave as he is when it comes to sharing my own stories. It is a pleasure to reply to him tonight.

The effects of bereavement and loss are different for us all, as my hon. Friend said. They can differ depending on age, on family circumstances and on whom we can reach out to for help, but one thing that I would really like to land is the fact that grief is lifelong. Grief never leaves us. When we lose a loved one, it stays with us for the rest of our life. My hon. Friend mentioned triggers, and they can happen at any point. It is important that I, as a Minister in the Department of Health and Social Care, ensure that we have sufficient support for people who are grieving, because it can come from nowhere. He used the word “normalise”, and that is so important when we talk about any aspect of mental ill health and mental stress, because it is not uncommon for us all to go through periods when we feel like that.

It is difficult, particularly for men, to reach out and ask for help. That is because it is seen as a sign of weakness, but it really should not be. “No man is an island” is the trite phrase that we often use, but it is also true. Sometimes, people feel that they cannot show weakness because they are the linchpin of their family and cannot grieve because they need to be strong for everyone else. It will be the mark of a compassionate society that we ensure that we have services for all those people. From a health perspective, it is also really important that we do that, because people who are suffering in this way are more likely to suffer from physical ill health and from weight loss, depression and anxiety. I have witnessed this within my own family following a bereavement. We must encourage people to access support from bereavement counsellors.

My hon. Friend spoke movingly about the fact that Mother’s Day was a particular trigger for him. He lost his mother and father at a young age, and the sense of grief when life ends prematurely is perhaps even more acute at that time. I was reminded of people I have met who were victims of terror, for example, or of Grenfell Tower. There, too, life ended very prematurely for those people. Sometimes we do not even think about the effects of seeing pictures of that fire flashed up every time Grenfell Tower comes up on the news. We risk re-traumatising people in that way, and as a society we really need to start looking at some of those behaviours. These things are often done with the best of intentions. I remember when we started the independent inquiry into Grenfell, there was obviously great interest in it on the news, but those pictures being flashed out on every news programme cannot have been pleasant for those left behind. There is a role for us to think carefully about news reporting, broadcasting and what is available on the internet. There is also a challenge for editorial teams about how to report such things after the event, because we really should not expect people just to tolerate living with ongoing trauma.

Bereavement counselling is available to people at any time, and it is important to realise that the grieving process does last a lifetime and that feelings could be suppressed for decades before being triggered again. The first step for someone wanting to access a counsellor should be to go to their local GP or to self-refer to Cruse, as my hon. Friend mentioned. I am pleased that we will be making more services available through the 111 facility, because people being able to access care, advice and support when they need it will mitigate any harm that they are experiencing.

Cruse Bereavement Care is funded by clinical commissioning groups and local authorities and has branches all over the country that offer free, confidential advice to anyone who needs it. Cruse’s aim is that everyone who loses somebody should have someone to talk to when they need it, and I am pleased with the service it offers. The quality of service could be improved, however, so we are working with NHS England to develop better provision so that everyone can access it.

I also cannot commend the voluntary and charity sector’s input enough. I keep saying to CCGs that we should not look at mental ill health just as something to be medicalised, because support from voluntary providers and people with other skills can be just as important in helping people to get better and get used to their condition as any appointment with a clinician. The 111 service will provide 24/7 mental health crisis support, enabling access to a trained mental health professional who can signpost to treatment and other support, but the system should be holistic, so we need voluntary services, bereavement counselling and mental health professionals where they are needed.

My hon. Friend told us this evening that Mother’s Day is a particularly difficult time for him, and any kind of anniversary can reignite grief. I was interested to hear about Bloom & Wild’s policy, which is a good reminder of how a bit of sensitive thinking can make life so much easier. I would encourage all companies that are involved in activity around such times—any business that builds relationships with its customers—to be more sensitive in how it contacts people. That is just good corporate social responsibility, as he said. Advertising in the United Kingdom is regulated by the Advertising Standards Authority, but it could do more to spread good practice and encourage companies to think more carefully, because everyone can support people who have been bereaved.

I am pleased to see my hon. Friend the Member for Eddisbury (Antoinette Sandbach) here, and my hon. Friend the Member for Banbury (Victoria Prentis) was here earlier. The Baby Loss Awareness Week debate is now an annual fixture, and there is never a dry eye in the House when hon. Friends share their direct experiences. I find it amazing that it was so taboo to talk about such things until recently, but in this sphere we have led the way in acknowledging our grief and talking about it, and in so doing we are setting a good example for the rest of society. I know that it is difficult for colleagues, as I said, to talk so rawly about the emotions that they have experienced, but when pictures go out from this House showing not a point-scoring bearpit but real naked human emotion, that is what the public want to see. They are the things that remind them that, in this place, we are all citizens of the United Kingdom with all the problems and challenges that everyone else has. We are not some class apart living a completely different life—not living in the real world, as some would say.

Those pictures from the annual baby loss debate open people’s eyes and tackle the taboo. I very much hope that people watching those debates will think, “Do you know what? It’s okay to feel bad. It’s okay to have a good cry about something that happened to me many years ago.” Grief is something you have to manage. You will never stop missing that loved one, and you will never stop regretting the fact you have lost them. Much of the time memories are happy and, in your own mind, you can celebrate their life and their contribution to your life, but the regret that they cannot see what you are doing now is something that never leaves you, and that is just a sign of being a good human being.

I sincerely thank my hon. Friend the Member for Boston and Skegness for securing this debate. He raised the issue of suicide, and particularly male suicide, which underlines the need to encourage men to acknowledge that it is okay to have a good cry and to ask for help. They do not have to be superhuman and it is not a sign of weakness. We need to do much more to encourage men to open up, and I have seen that directly in my role as Minister for suicide prevention. I have met families who have lost young men to suicide, and it might sound weird, but it is a privilege to have heard their stories and for them to be able to share their pain. I find it so inspiring that people who have gone through the most tragic things want to use that experience to make life better for everyone else.

Perhaps that is a good note on which to finish. We are all very proud of my hon. Friend, because he has done exactly that. He has shared his pain so we can all learn from it. That is the best of Britishness.

Question put and agreed to.

Oral Answers to Questions

Jackie Doyle-Price Excerpts

Tuesday 26th March 2019 Commons Chamber

[Liz Twist (Blaydon) (Lab)]

3. What assessment he has made of the effect on life expectancy projections of health inequalities; and if he will make a statement.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

The latest work from the Office for National Statistics shows that life expectancy is projected to increase, but none the less there are inequalities within those figures. That is why we are taking action to reduce smoking, prevent cardiovascular disease and diabetes, improve cancer outcomes and, of course, tackle childhood obesity. I can also add that reducing health inequalities is an important component of our NHS long-term plan. All local health systems will be expected to set out how they will specifically reduce health inequalities by 2023-24.

[Liz Twist]

Sir Michael Marmot, the world-recognised authority on public health, has warned that the country has, since 2010, stalled in the task of improving the life expectancy of our population. There are already wide inequalities. For example, a Gateshead man can expect to have 57 years of life in good health, compared to the England average of 63.4 years; and a Gateshead woman can expect to have an average of 59.1 years in good health, compared to the England average of 64.1 years. What is the Minister doing to redress those real inequalities?

[Jackie Doyle-Price]

As I mentioned, the NHS long-term plan will be asking local health systems to specifically address this issue. Certainly, there are particular trends that I personally want to address. They are the real inequalities that affect people with learning disabilities, which are worse than the figures the hon. Lady mentions. We also see that the outcomes she refers to can be laid at the door of a slowdown of heart disease and stroke mortality improvements, so we really need to focus our interventions there. We are also seeing an increase in the fall in life expectancy due to alcohol misuse.

[Rehman Chishti (Gillingham and Rainham) (Con)]

Medway has some of the highest health inequalities in the country. As the Minister rightly says, high inequalities are linked to a greater chance of a stroke. Despite that, the sustainability and transformation partnership and the clinical commissioning group decided to put an acute stroke service in Dartford, which is very close to London and is served by King’s College London. The criteria was not followed correctly. The matter is now with the Secretary of State to review. Can the Minister assure me that the criteria will be re-looked at to ensure that justice is done?

[Jackie Doyle-Price]

My hon. Friend will know that this has to be reviewed independently, but the Secretary of State does have duties to consider inequalities in all his work.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I, too, wish to pay tribute to the hon. Member for Winchester (Steve Brine), who I sparred with many times in Westminster Hall. We might not have agreed on how to go about it, but he was clearly passionate about improving health.

The Secretary of State’s vision for NHS England includes video links to GPs, diagnostic phone apps and healthy people undergoing gene tests for a few hundred pounds. Considering his own experience of such a gene test, does he not recognise that this just increases access for the well-off, will drive demand in the system and will actually widen health inequalities?

[Jackie Doyle-Price]

I do not accept that at all. Apart from anything else, we are seeing younger generations be more technologically savvy. We are taking advantage of that technological innovation to spread good health prevention and to help people look after themselves.

[Mr Speaker]

I call Dr Philippa Whitford.

--- Later in debate ---

[Mary Robinson (Cheadle) (Con)]

11. What steps he is taking to tackle cervical cancer.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

We have some of the highest HPV—human papillomavirus—vaccination rates in the world. This month we launched a major new national campaign to increase the number of women attending cervical screening across England, and throughout the NHS long-term plan we have committed to radically overhaul screening programmes and further invest in the latest technology to transform diagnosis and boost research and innovation.

[Mary Robinson]

Figures from Jo’s Cervical Cancer Trust show that 200,000 women in Greater Manchester have missed their smear test, including half of women aged 25 to 29, yet we know that smear tests save lives. What are the Government doing to raise awareness of the importance of attending screening to prevent cervical cancer?

[Jackie Doyle-Price]

My hon. Friend is right: cervical screening saves up to 5,000 lives every year, so we cannot do enough to encourage women to take advantage of the screening. It is not the most pleasant experience to go through, but it can save lives. I would encourage everyone to take advantage of the screening, and we will continue to do our best to promote it.

[Chi Onwurah (Newcastle upon Tyne Central) (Lab)]

In Newcastle, cervical screening rates have fallen since 2010: they range from 85% to just 23% and are consistently lower in poorer areas and among younger women and ethnic minority women, and across the UK women are more likely to die in more deprived areas. What specifically is the Minister doing not just to encourage women to attend but to make screening more available at the weekends, out of hours and closer to where people live?

[Jackie Doyle-Price]

The hon. Lady makes some excellent points and highlights those areas of the community where take-up is much lower. We need to be more imaginative about how we promote the need for screening, and in that regard I am very pleased to see the work of Jo’s Trust, and also that of the Eve Appeal to raise awareness. We can all do our bit, and I would encourage everyone to spread the word about the need to get screened.

[Mrs Sharon Hodgson (Washington and Sunderland West) (Lab)]

I, too, want to start by paying tribute to my hon. Friend the Member for Ellesmere Port and Neston (Justin Madders)—he is a big loss to the Front Bench—and also to the Minister I used to shadow, the hon. Member for Winchester (Steve Brine). Credit where it is due: I know cancer charities and campaigners are all tweeting their regret, because the hon. Gentleman was, and hopefully will remain, a true ally of that cause.

Cervical cancer is the most common cancer in women. Smear tests can prevent 75% of cervical cancers from developing, but one in four women do not attend their smear tests and screening is now at a 21-year low. This was not helped by the failure of the outsourced screening to Capita, which failed to write to 48,000 women in six months. What are the Government going to do to ensure that women and girls know what happens at a smear test, what it is for and why it is so important?

[Jackie Doyle-Price]

As the hon. Lady will know, we have brought that service back in-house, but we should leave no stone unturned in relation to thinking more imaginatively about how we spread the word about the need for screening. I should like to pay tribute to those celebrities who have tweeted pictures of themselves going for their smear tests, because it is only by normalising it and ensuring that everyone realises that it is something they should do that we are going to encourage take-up.

[Helen Whately (Faversham and Mid Kent) (Con)]

12. What steps he is taking to improve access to GPs.

--- Later in debate ---

[Lloyd Russell-Moyle (Brighton, Kemptown) (Lab/Co-op)]

15. What recent discussions he has had with the Secretary of State for Education on ensuring that lessons on HIV and sexual health form a core part of the relationships and sex education curriculum.

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

All children should receive good-quality relationships and sex education so that they understand the benefits of healthy relationships and how to protect themselves against sexually transmitted infections, HIV, unplanned pregnancy and abuse.

[Lloyd Russell-Moyle]

Does the Minister believe that the £6 million allocated for relationships and sex education is enough when it equates to a few hundred quid per school? Her Department has cut £3.2 billion from public health spending, meaning that many young people now cannot access STI testing, and we are seeing a boom in STIs among young people.

[Jackie Doyle-Price]

The hon. Gentleman’s question is actually a matter for the Department for Education, but I do not accept his statement. The new relationships and sex education proposals were widely welcomed across the House when they were announced, and we will improve children’s ability to look after themselves and have healthy sexual relationships.

[Stephen Crabb (Preseli Pembrokeshire) (Con)]

T1. If he will make a statement on his departmental responsibilities.

--- Later in debate ---

[Debbie Abrahams (Oldham East and Saddleworth) (Lab)]

T6.   My constituent, who has terminal secondary breast cancer, has had her personal independence payment assessment refused and is having to appeal the decision, in spite of doctors’ letters detailing her debilitating condition and the treatment regimen she has to go through. What discussions has the Health Secretary had with the Secretary of State for Work and Pensions on how to ensure that medical evidence of that sort is accepted, so that people with terminal and progressive conditions do not have to go through this awful process?

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

The hon. Lady makes a very good point. I had regular discussions with the sadly departed Minister for Disabled People, Health and Work, who provided really great challenge within the Department for Work and Pensions about how it handles such assessments. We must do all we can do to humanise them, especially when people are going through periods of ill health.

--- Later in debate ---

[Nicky Morgan (Loughborough) (Con)]

ADHD Solutions is a community interest company based in the constituency of the shadow Health Secretary that serves children and young people with ADHD across Leicester and Leicestershire. Fifty per cent. of its referrals come from the NHS, yet it does not get funding for those referrals; however, those NHS services are able to meet NICE guidelines because ADHD Solutions is doing the job. Will the Health Secretary meet me and the shadow Health Secretary to discuss that?

[Jackie Doyle-Price]

I have corresponded with my right hon. Friend and the hon. Member for Leicester South (Jonathan Ashworth), but I am more than happy to meet them to discuss that issue. From my perspective, services for people with ADHD are a bit of a Cinderella and I would like to do my best to address that, working with colleagues across the House.

[Ms Karen Buck (Westminster North) (Lab)]

With a throwaway answer to the right hon. Member for Chelsea and Fulham (Greg Hands), the Secretary of State has just pulled the west London strategic health framework, which has governed the delivery of hospital and community services for most of the last decade, absorbed tens of thousands of hours and cost hundreds of millions of pounds. Why has he not thought it appropriate to bring forward a statement so that the many of us who are concerned with this issue have an opportunity to interrogate the many very serious implications that this has for the delivery of healthcare across west London?

Mental Health Workforce Data

Jackie Doyle-Price Excerpts

Thursday 21st March 2019 Written Statements

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

The NHS long-term plan set out this Government’s ambition to transform how the NHS supports mental health, building on the work already under way to deliver the commitments in the “Five Year Forward View for Mental Health”.

Our plans depend on having the right workforce in place. The Government, in consultation with NHS England, Health Education England and NHS Improvement, asked NHS Digital to review how it counts the mental health workforce with the goal of providing us with a more accurate possible baseline against which to track progress towards delivering our ambitions.

Previously, several different approaches had been taken, including counting total numbers of staff working in mental health, learning disability and care trusts, which included staff working in other specialisms, such as community health staff who support people’s physical health. NHS Digital has developed a new approach that will improve accuracy by counting only those staff who work directly on mental health, regardless of the type of organisation in which they work. It will also provide a greater level of transparency in relation to the workforce, for example, staff working in priority areas, such as crisis care or children and young people’s mental health services.

NHS Digital will publish its quarterly mental health workforce data under this new definition on 21 March 2019. Because it focuses on staff working directly on mental health in NHS trusts and NHS foundation trusts, the new headline figures will show a smaller total number of people working in mental health They do not yet provide a full picture of the mental health workforce. For example, they do not include the very significant number of staff providing NHS-funded mental health services in other organisations such as the voluntary sector, local authorities and primary care settings. We are therefore planning further changes to the data in the future to enable us to better understand these staff numbers and associated patient outcomes.

This new approach underlines the scale of the challenge ahead of us to make the increases we all agree are needed to the mental health workforce and bring about improvements to the lives of the people they are here to support. The Government are committed to meeting this challenge. Following the recent publication of the NHS long-term plan, the Prime Minister and Secretary of State for Health and Social Care asked Baroness Dido Harding to develop a workforce implementation plan.

An interim workforce plan will be published in the spring and will include an immediate 2019-20 action plan together with a more detailed vision of how the health and care workforce will transform over the next 10 years to deliver 21st century care for our patients. The plan will build on work already under way to recruit, train and importantly retain more staff to address our most immediate shortages.

[HCWS1433]

Health Inequalities

Jackie Doyle-Price Excerpts

Wednesday 20th March 2019 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

It is a pleasure to serve under your chairmanship, Mr Hollobone, and to respond to the debate. I feel that it is a major challenge and an absolute responsibility for Ministers in the Department to do everything we can to tackle inequalities. Frankly, that is why all of us got involved in politics and stood for public office, because we want to do the best for everyone in our society.

I pay tribute to my hon. Friend the Member for Telford (Lucy Allan) for her very persuasive argument in opening the debate. She has been an absolutely fantastic champion for her constituents, at a time when difficult decisions are being made about how to reconfigure health services in her area. She has not been backward in coming forward to make her case, because this is the second time that I have responded to her on it. I know that she will continue to make her case.

I will just say something about some of the concerns that my hon. Friend has raised. When the NHS makes decisions on how best to deliver health services for a local community, clearly those decisions are made locally and should be locally responsive. However, it is equally the case that the public become very nervous about the potential downside of any decision. It is therefore absolutely crucial that engagement is constructive, with dialogue and transparency, so that the public can have confidence that the right decisions are being made.

My hon. Friend articulated her case with clear reference to inequalities in the area that is served by that configuration. It is important that we have a way of addressing those points, because there is a perception that the pointy-elbowed middle classes are better at fighting for themselves than everyone else is. We all have a duty to ensure that everyone can have confidence in the decisions that are made. I encourage my hon. Friend to continue to give challenge, because it is only when we provide her with answers that she can give her constituents reassurance. I know that she will continue to give that challenge.

On that basis, I would give a gentle prod to some organisations within the NHS. We often find that some areas are better at consultation than others, but we are elected representatives who are here to give challenge on behalf of our constituents, and I would like to send a message that the NHS needs to be more transparent in its decision making throughout.

I thank all Members for their contributions to this debate, and I will try to address most of the points that have been raised. Turning to the legal duties on the Secretary of State, we have regard to the need to reduce health inequalities. That requires concerted effort across all our health services. That is a priority for us, and it is a particular priority for me. Clearly, other factors contribute to poor health outcomes and inequalities, which go beyond the gift of the NHS and the Department of Health and Social Care, meaning that we need to take a cross-Government approach to the problem. Housing is clearly an issue; we know that poor-quality housing can be a driver of ill health and health inequality. We have heard about employment and income, and clearly education is a factor as well. We need to equip everyone with the tools to live a healthy lifestyle and look after themselves well. Equally, this issue is about access to services, and we know that there is much we can do within the NHS and the wider healthcare system.

[Debbie Abrahams]

Is the Minister aware that there was an interdepartmental public health group specifically to look at the wider determinants of health and how each Department could do its bit? Would she consider re-establishing that group to address the important issues that have been raised?

[Jackie Doyle-Price]

We have a number of inter-ministerial groups looking at particular areas of inequality, such as rough sleeping and the first 1,001 days. The hon. Member for Central Ayrshire (Dr Whitford) spoke about the importance of early intervention; if we could get that right, that would be a real way of addressing inequality. My short answer to the question asked by the hon. Member for Oldham East and Saddleworth (Debbie Abrahams) is that we pick up public health in a number of ways, but my priorities are the first 1,001 days and particular pinch points where there are real inequalities. We will continue to look at those areas, not least because supporting those individuals is not just better for them, but makes financial sense. If we can tackle some of these issues earlier, not only do individuals live longer and healthier lives, but there is a reduced cost for the health system.

[Dr Whitford]

Many of us have spoken about the fact that poverty drives ill health. Can the Minister tell us whether any discussion is taking place between the Department and the Department for Work and Pensions about the impact of welfare changes over the past few years, and how to tackle them?

[Jackie Doyle-Price]

I have been in close consultation about that issue with the recently departed Minister of State for Disabled People, Health and Work, my hon. Friend the Member for Truro and Falmouth (Sarah Newton). She has really challenged the DWP to look after people who are vulnerable, and put in place safeguarding policies for them, so I confirm to the hon. Member for Central Ayrshire that that discussion is taking place.

My hon. Friend the Member for St Ives (Derek Thomas) raised the issue of dementia. Clearly, dementia has a big impact on the number of years in which people can enjoy a healthy life, and we must get that right. For that reason, we have introduced the ageing society grand challenge, which is focused on narrowing those inequalities. My hon. Friend is right that we must have better integration with social care; there have been a lot of moves towards better integration between local authorities and the NHS, and that must continue.

The hon. Member for Washington and Sunderland West (Mrs Hodgson) referred to public health cuts. We have tackled those through the NHS forward plan, and have said that this is an area in which we expect the NHS to focus and work collaboratively with local government, specifically highlighting health visitors and the wider public health agenda. My answer to the hon. Lady’s point is “watch this space”, but we recognise that we spend less if we spend wisely, which has to be about getting the system to work better.

[Derek Thomas]

rose—

[Dr Whitford]

rose—

[Jackie Doyle-Price]

I have limited time, and I would like to get through this.

We have made it clear that the long-term plan will be focused on reducing inequalities. The hon. Member for Strangford (Jim Shannon) mentioned people with learning disabilities and autism, and I can tell him that those people are a real priority for me. When we consider inequality, the life expectancy of people with those conditions is massively less than it ought to be, and we need to fix that. This year we expect all local health systems to set out how they will reduce health inequalities by 2023-24 and by 2028-29. Through that, we are targeting specific areas. NHS England will highlight areas in which it can do specialist commissioning. One example is people who are rough sleepers, who have low levels of life expectancy.

I absolutely agreed with what the right hon. Member for Rother Valley (Sir Kevin Barron) said about social prescribing. How we deliver health services depends not only on medicalised professions and clinical support; when tackling inequality, a lot of the wrap-around and de-medicalised support can deliver better health outcomes. I am very excited to hear about what is happening in Rotherham, so I might pay a visit next time I go to see my mum. That would be quite nice.

Turning to the specific points made by my hon. Friend the Member for Telford about her local trust and the impact on inequalities, she has clearly articulated the issues that she is concerned about. The decision is clearly a local one, but it is within the gift of the council to make an appeal to the Secretary of State, and I gather from my hon. Friend’s comments that that will happen. I obviously cannot prejudge the outcome of that case, but I assure her that when it arrives on the Secretary of State’s desk, he will consider it impartially. She has articulated the concerns from her constituents’ perspective extremely well.

I am under no illusion about the fact that tackling inequality requires commitment and leadership, energy and focus, and national and local accountability. Let us look at the plans that come from clinical commissioning groups later this year and interrogate them to make sure that they will tackle inequality. We will make sure that we stand fully behind them to ensure that they deliver.

Human Medicines (Amendment) Regulations

Jackie Doyle-Price Excerpts

Monday 18th March 2019 Commons Chamber

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

I am grateful for the opportunity to address the House and reassure Members on both sides of the House about the purposes of the regulations. I have been asked a number of questions, and I will try to answer all of them as best I can.

I want to start by saying that there is considerable misinformation out there about these regulations, which are designed to most efficiently manage the supply of medicines in the event of a shortage. I should also make clear to the House that this is not just a Brexit regulation; it will apply in any case, not just in the case of no deal, not least because recent events have shown the challenge in managing medicines. The regulations on how pharmacists will be able to apply this protocol are designed to minimise not only the demand on GPs but the risk to patients, because pharmacists will only be able to use their powers under these regulations according to very clear criteria, and we will still encourage them to speak to prescribers where there is any element of doubt.

[Anne Marie Morris]

Will the Minister give us some details about what those criteria will be, so that clear decisions can be made by pharmacists and so that when a particular brand is really important for a patient, there is no possibility that a generic will be substituted?

[Jackie Doyle-Price]

The circumstances will be different from protocol to protocol, which is not a very clear answer—but we would have to look at each incident. The hon. Member for Leicester South (Jonathan Ashworth) mentioned HIV medicine. Another example is antipsychotic medicines, where there is a clear relationship with the patient: obviously, it would not be appropriate to unilaterally change those items of medication.

When a prescription is issued, the pharmacist has to dispense that medicine according to strict instructions under the terms of the prescription. For example, if the prescription was for packets of 200 mg tablets and there was a shortage of those, they could be substituted with a different measurement. All those issues would be dealt with from protocol to protocol, having been considered by a pharmacy panel who can properly and rigorously challenge what an appropriate substitute would be in the event of a shortage of any medicine.

[Anne Marie Morris]

Is the Minister not concerned about the challenge that, however qualified the pharmacist, they do not have the patient’s notes? She has referred to an amount, and I understand how having two smaller pills will equal what should have been prescribed, but when it is a generic versus a specific branded medicine, that is a very difficult and challenging decision to make.

[Jackie Doyle-Price]

I come back to what I said to my hon. Friend earlier. The terms under which pharmacists will be able to exercise their discretion will be clearly set out in each protocol, and there will be full consultation by an expert panel, with ministerial approval in such an event.

[Norman Lamb]

Will the Minister clarify whether, if there are adverse effects as a result of some change that has been made in these circumstances, the prescriber, the dispenser or the Government would ultimately be liable?

[Jackie Doyle-Price]

The protocol will be very tightly drafted, which will really limit the ability of the pharmacist, who would only be able to prescribe outside the terms of the prescription within the narrow confines of the protocol. As I say, this has been done to secure continuity of supply when there is a potential challenge, but I would expect to take advice from a pharmacy panel, in conjunction with those most affected, to make sure that we put in place appropriate risk management on those occasions.

[Helen Goodman]

What kind of timescale is the Minister considering? Let us take people with epilepsy. As my hon. Friend the Member for Leicester South (Jonathan Ashworth) said at the Dispatch Box, if somebody’s condition changes, it might take six months to work out what the right prescription ought to be. The Minister surely cannot say that we will write a protocol in Whitehall in the event of some sudden shortage and implement it across the land because, as we keep saying, different people have different medical needs.

[Jackie Doyle-Price]

We are talking about a protocol that can deal with an immediate shortage, but we would not expect that shortage to continue indefinitely. It enables us to manage the shortage, while trying to secure the ongoing supply.

Reference has been made to EpiPens, and that is exactly what happened in that context: we knew that we had a shortage and that there was a supply coming, so steps were taken to manage the supply so that everybody who needed EpiPens had a supply of two, with dispensaries managing that supply. We would expect the same to happen. Where we issue a protocol, we would expect prescribers to go back to their normal supply of medication once we had corrected the supply problem, and this is to get us through that period. It is also to encourage people not to stockpile medicines in the event of worries about a shortage. This is about giving people the reassurance that we will manage such shortages effectively.

The hon. Member for Leicester South mentioned that there had been criticism about a lack of consultation. It is worth noting that the Government have been challenged by the Good Law Project on a number of grounds, but it is also worth telling the House that the High Court decided last week that permission for judicial review would not be granted on the issue of lack of consultation.

I want to clarify the purpose of the regulations. First, they implement the EU falsified medicines legislation on certain safety features on the packaging of medicines. They also extend the exemption for the supply of naloxone hydrochloride, so that drug treatment services can supply all dosage forms of that medicine; at the moment, we can only supply injectables, but we now know that nasal administration is more efficient. In addition, and this is obviously the main crux of the debate today, they enable retail pharmacies, where appropriate, to supply against a serious shortage protocol, instead of against prescriptions, if such a protocol has been issued.

Not implementing this statutory instrument would have dire consequences. Not only would the Government lose this tool to manage shortages of medicines, but we would also deny drug treatment services the ability to supply all dosage forms of naloxone hydrochloride. Without this SI, we would not be able to introduce UK-specific flexibilities for the falsified medicines safety features scheme, meaning that a disproportionate burden would be put on the supply chain.

On the safety features, I would like to say that we are committed to stopping falsified medicines from reaching patients. Our No. 1 priority is safe access to medicines in the most efficient way. I can also say that we want to retain a close working partnership with the EU on medicines regulation, for all the reasons the hon. Gentleman outlined, and we wish to ensure that patients continue to have timely access to safe medicines and medical innovations.

The new safety features measures under the EU delegated safety features regulation are directly applicable, and they already require UK manufacturers to place a unique identifier and tamper-evident features on packaging for almost all prescription-only medicines. These medicines need to be scanned on supply to the patient to verify their authenticity. Our position is clear that, as a member state, we were obliged to implement these requirements. We worked extensively with stakeholders to understand the detail and to develop the best approach on the flexibilities and enforcement specifically for the UK, and this was tested through a formal consultation process.

It is worth noting that the UK has a very complex supply chain. Without the national flexibilities in this statutory instrument, the burden on industry would be disproportionate and it would risk patients not getting timely access to medicines; nor would we be able to enforce the requirements already in place. The reputation of UK medicines, the UK pharmaceutical industry and regulators could be seriously undermined. I have already mentioned the issue of naloxone hydrochloride. It is administered in the event of a heroin overdose, so we clearly want to make that available in the most efficient way possible.

To come back to the serious shortage protocol provisions, these will provide the Government with an additional tool to deal with a shortage of medicines. Over 2.5 million prescription items are dispensed in primary care in England alone every day, and the vast majority are not subject to supply problems. However, we must have a robust system in place for when they are. We work closely with the Medicines and Healthcare Products Regulatory Agency, the pharmaceutical industry and NHS England in operating and managing the supply chain to help prevent shortages, and to ensure that the risks to patients are minimised when shortages do arise.

The issue of EpiPens is a very good example. Last autumn, we faced a serious international shortage of EpiPens. That shortage had a knock-on effect on other adrenaline auto-injectors and, despite efforts by the Department and the industry, there was not enough supply to meet the demand in the country. We were therefore forced to ration the available injectors so that the available supply could be spread out across all patients who needed them until more stock became available. To be able to do that, we put in place a dispensing protocol.

The protocol required pharmacists to check with patients how many adrenaline injectors, including expired ones, they had so that pharmacists could decide on the number of injectors to supply. Patients below a certain weight had to be referred back to their prescriber. Again, another risk management tool that we would apply in issuing a protocol would be to make sure that pharmacists were referring people back to their prescriber if there was such a question. This ensured that, throughout the duration of the shortage, we managed the available stock in such a way that each patient had access to at least two injectors. It was this incident with the adrenaline injectors, as well as our EU exit preparations, that led the Government to formalise that what was done in the EpiPen situation should be put in place to manage other serious shortages, should they arise.

I say again that this is not the Government’s plan for dealing with medicine shortages in a no-deal exit. That is simply not the case at all. We wanted to introduce these provisions before 29 March so that we would have the option of issuing protocols, but only as part of our multi-layered approach to minimise any supply disruption in a no-deal exit. We are confident that our other management plans will deal with that. These include securing additional roll-on roll-off freight capacity for goods; buffer stocks and stockpiling; extra warehouse space; and space on aeroplanes for products with a short shelf life or specific storage conditions. The questions raised about radioisotopes are clearly relevant to that. These regulations will ensure that companies can continue to sell their products in the UK. They will strengthen the process and resources used to deal with shortages in the event, despite everyone’s best efforts, that they do occur.

[Anne Marie Morris]

The Minister is being generous with her time. Will she explain what currently happens when there is a shortage? Of course I realise that patients need medicines, but why do we need this specific piece of legislation when, so far, the Government have dealt with many other shortages reasonably adequately, I should have thought?

[Jackie Doyle-Price]

As I explained, it was the issues regarding EpiPens that brought home to us the need to have a suitable protocol in place.

Hon. Members have expressed concern about the role of pharmacists in the system. At the moment, where the prescriber has prescribed a specific medicine, including a specific strength and quantity, the retail pharmacist must supply exactly what is on the prescription and cannot deviate from that. The pharmacist has no flexibility if the exact order cannot be supplied, for example, because of supply issues. The pharmacist has to send the patient back to their GP. Clearly that would not be an efficient use of GPs’ time if we could put in place a protocol that would enable the application of alternative medicines.

The serious shortage protocol enables retail pharmacists to supply in accordance with a strict protocol for a specific prescription-only medicine, rather than against a prescription, without going back to the prescriber. That will be done only in exceptional circumstances, in the event of a serious shortage of a medicine, when all other mitigation measures have been exhausted or would be likely to be ineffective, and all the clinical community think it is appropriate to issue such a protocol. The protocol may prescribe one of the following options: an alternative quantity, an alternative pharmaceutical form, an alternative strength, a therapeutic equivalent or a generic equivalent. However, as I said, each case will be considered on its merits, and of course the risk of various health conditions. We believe that therapeutic substitution will be extremely rare. It would need to be clinically appropriate, and a sufficient stock of any alternative would be required.

As I have said, any serious shortage protocol will be developed with clinician input. Which clinicians are involved will depend on the expertise required, but we would involve, for example, the relevant royal colleges and societies. We would also work closely with patient representative groups, as we did in the EpiPen shortage. Each protocol would clearly set out what action can be taken by the retail pharmacy, in what circumstances, for which patients, and during which period. I re-emphasise that this is not about pharmacists acquiring prescribing rights by the back door. It is entirely about ensuring that patients have access to the medicine they need by making the best possible use of highly qualified pharmacists and freeing up GP time for patients who need to see their GP. If a pharmacist is in any doubt about what they are prescribing, they can always exercise their professional judgment to refer an individual patient back to the GP, and if patients do not want the alternative under the protocol, they can always go back to their prescriber.

Let me be very clear: patients will not be given alternative medicines where this is not medically appropriate. This includes patients with complex medication regimes or conditions such as epilepsy or HIV. However, that does not mean that they are exempt from the protocols. For example, a protocol for a reduced quantity of anti-epilepsy medication could be issued, as we did for EpiPen. That would have to be considered against a backdrop of all the available stock being spread out across all patients, and there being time for patients to see their prescriber if the supply issues become long- term. Without the protocol, some patients would receive the medicines prescribed to them, but some would leave the pharmacy empty-handed. Clearly, we need to make sure that all patients have timely access to their medicines.

In the event of a serious shortage of any medicine, it is vital that patients continue to receive the treatment they need. The introduction of strict protocols, developed with specialist doctors, is a sensible step that will, in exceptional circumstances, allow highly trained pharmacists to provide an appropriate alternative or quantity, as set out in the protocol, to reduce the impact on patients. This ensures a co-ordinated response to a shortage and timely access to medicines.

Of course, I hope that we never have to introduce a serious shortage protocol, but there may be times when we have no other options, because all other measures have been exhausted or are likely to be ineffective. Not implementing the statutory instrument would put patients’ timely access to medicines at risk, first, by not enabling drug treatment services to supply all dosage forms of naloxone hydrochloride; secondly, by imposing much more burdensome implementation of safety features of packs of medicines with flexibilities to accommodate the specific characteristics of the UK supply chain; and thirdly, by denying the Government an important tool to manage shortages of medicines and to ensure that patients continue to get the right medicines in a timely manner. I hope that the motion is defeated.

--- Later in debate ---

[Mr Ivan Lewis (Bury South) (Ind)]

I am glad we have had the opportunity to have this debate. Like other hon. Members, I want to focus on the impact these changes could have on those with epilepsy. I thank SUDEP Action, which the right hon. Member for North Norfolk (Norman Lamb) mentioned, for the work it has done to bring concerns about this issue to the fore. I also agree with many of the concerns my hon. Friend the Member for Leicester South (Jonathan Ashworth) expressed in his opening remarks.

The Secretary of State was unable to address bereaved families and clinicians at the recent summit held by SUDEP Action, but will he meet me, other hon. Members and representatives of SUDEP Action and talk directly to families about the concerns they have? If he could agree to do that, it would be very helpful.

Medicines shortages pose a serious risk to people with epilepsy. As hon. Members are aware, it is a high-risk condition, requiring complex, tailored care. As other hon. Members have said, many people with epilepsy are particularly vulnerable to changes to that care. I have recently met families, such as that of Rachel Shah, whose daughter Emily died aged 19 shortly after a non-specialist prescriber made an error with her medication. The family and the non-specialist were entirely unaware of the risks of sudden unexpected death in epilepsy, and the error was not noticed. That is quite shocking.

Studies show that people on existing medications are put at risk when those medicines are changed. Tried and tested systems mean that, when there is a medicines shortage, specialist prescribers with expertise and access to the full patient record are involved in any changes. There are known risk factors that can increase the risk of death among people with epilepsy. However, those can be carefully managed through open, positive relationships between clinicians and patients. Those clinicians have often had responsibility for the patients’ medication schedule, which has often been worked up with the patient over many years.

The serious shortage protocols, passed under the Human Medicines (Amendment) Regulations 2019 give pharmacists the right to supply a different quantity or pharmaceutical quality of medicine in the event of the country experiencing a serious shortage of prescription-only medicines. As other hon. Members have said, pharmacists are skilled professionals in medicines and medicines management, but they are not specialist prescribers. Nor are they specialists in assessing SUDEP or other epilepsy risks in individuals, and they do not have access to full patient records.

[Jackie Doyle-Price]

With your indulgence, Madam Deputy Speaker, I would just like to reassure the right hon. Member for North Norfolk (Norman Lamb) and the hon. Member for Bury South (Mr Lewis). We do not consider that treatment for epilepsy would be appropriately covered by a serious shortage protocol, for exactly the reasons that they have both outlined: this is specialist prescribing and very bespoke to the patient. In the event of a shortage of epilepsy drugs, the clear guidance would be for the pharmacist to refer the patient back to their prescriber. The shortage protocols will be very tightly defined, within given circumstances, as to what drug will be an appropriate alternative treatment; they are by no means meant to be very one size fits all.

[Mr Lewis]

I think the Minister for that reassurance. I think we will want to see that in writing. Having that clarity is incredibly important, so that when the guidance is published, the reassurance is there for people with epilepsy and their families. That is incredibly important.

We should remember that laws that sought to allow change in the prescription of epilepsy medications were rejected in 2010 after a public consultation that highlighted major patient safety concerns. MHRA guidance in 2017 included vital safeguards against switching medication for people with epilepsy. These issues have therefore been interrogated in the past.

A precautionary approach concerned with patient safety would include analysis and openness about the causes of medical shortages; include an impact and risk assessment; aim to avoid any risk of worsening medical shortages; follow good practice in the regulation of medical shortages; include training and communication arrangements for all affected; and include clear, robust and timely accountability to patients and the public for adverse events and avoidable deaths. Nurses and clinicians are currently unable to gain access to a number of medications. They need to know which are on the list of likely shortages, and whether all the possibilities of measures to prevent such shortages have been exhausted.

People with epilepsy are recognised to be a high-risk group in current legislation. They must be protected against shortages of any medications that they take—not just their epilepsy medication—by a requirement in the legislation, and in any accompanying guidance, for the involvement of a specialist prescriber at all times. To be fair, that is the assurance that the Minister sought to give this evening.

It is not good enough to say in the explanatory memorandum that protocols will not apply to certain epilepsy treatments for which a brand is required. Any change in the 2017 MHRA guidance on epilepsy medication should be avoided, although, if such a change is required owing to a serious shortage, it must follow public consultation with the involvement of the third sector and patients. I think that patient groups feel they have been excluded from the process thus far. I urge the Minister to agree—in the spirit in which she has engaged with the House this evening—to meet SUDEP Action along with me, and other Members, if the Secretary of State is not willing or does not have time to do so.

The Government should make publicly available the list of medications that are at risk of shortage. If people living with long-term health conditions, and their clinicians, know about serious shortages that may affect them, they should have opportunities to contribute to any consultations and debates. An early-warning system for prescribers is essential, but it must be extended to all specialist prescribers. Many are on the front line, trying to ensure continuity of medication for patients, and they will be able to provide the necessary reassurance for those patients if they are aware of potential shortages.

We should not forget the anxiety that this will cause among people who are already extremely vulnerable, and the fact that that anxiety could lead to further health problems. All who are involved in the chain need to be able—where appropriate—to offer the maximum clarity, information and reassurance. The Government should also publish an operational framework and guidance to ensure that there is good practice and medicine shortages can be managed safely. They should commit themselves to patient-centred and shared care decision-making.

Perhaps this is the most important point that has been made so far: it is still not clear where accountability lies in the event of an adverse event—worst of all, a death—when there has been a failure of continuity of supply lines. That issue has been highlighted by the Pharmacists’ Defence Association. Obviously the association is very concerned about the potential negative effect on pharmacists, but a greater concern relates to the potential impact on patients and families.

This legislation is not simply another complication caused by Brexit. It may present serious challenges for many years to come. It is first and foremost about patient safety, and in those circumstances, the Government need to take appropriate time and care when making their decisions.

--- Later in debate ---

[Helen Goodman]

Of course what my hon. Friend says about staff shortages and Brexit is absolutely right.

I was going on to say that I have a GlaxoSmithKline factory in my constituency, and obviously I have discussed this issue with it. It is extremely underwhelmed by the Government’s no-deal planning, and extremely under- whelmed by the fact that it is having to pay for these extra stockpiles. All these Brexit costs that are being put on to the industrialists mean that there is less money for research and development, investment, job creation and all the things we would all like to see.

It is notable that there are very high numbers of people with the conditions most likely to be affected. There are 4 million people in this country with diabetes, 500,000 people with epilepsy, and 250,000 people whose allergies are so serious that they need an EpiPen. Given that we clearly have 5 million, 6 million or perhaps 10 million people whose health is likely to be at risk if there are medicine shortages, I would have thought that the Government would have not just done a full risk and impact assessment but produced for us today, alongside the statutory instrument, the protocols. The Minister knows which drugs and conditions we are talking about; surely, given all the problems we have had with the industry, doctors and patient groups not being properly consulted, it would have been sensible to make those protocols at this moment, so we could look at them alongside the statutory instrument. I hope the Minister will come to the Dispatch Box and answer some of these points. She is shaking her head.

[Jackie Doyle-Price]

This is a tool to manage serious medicine shortages. I do not expect any medicine shortages, but this tool exists in the event of them arising. As for the idea that we could bring together a list, we do not anticipate that there will need to be a list.

[Helen Goodman]

Brexit is now 11 days away. Collapsing out of Europe with no deal is obviously far less likely following the votes of last week, but it is still a possibility, and at that point the possibility—the probability—of these medicine shortages will increase very significantly. Here we are, less than a fortnight away, and the Minister has not got these protocols in draft at the moment. [Interruption.] The Minister is still chuntering; I am sorry, but she has not provided us with the reassurance that we want. I speak as someone who carries an EpiPen; I am not very taken with the idea that I will not be able to get an EpiPen, and my husband will not be very taken with the idea that he cannot get his epilepsy tablets. If the Minister and Department of Health and Social Care officials think that this is a way to save money, they could not be more wrong.

When things go wrong—when a person has a fit, or goes into anaphylactic shock—they are taken into A&E, and they might be there for 12 hours. That is not cheap; that is not a saving. Of course, it is extremely dangerous, too. The rate of death for people with epileptic fits is one in 100; one in 100 fits leads to death. Ministers are taking much too great a risk with their fellow citizens’ lives.

Question put.

Depersonalisation Disorder: NHS Treatment

Jackie Doyle-Price Excerpts

Tuesday 12th March 2019 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

It is a pleasure to serve under your chairmanship, Mr Gray. It is also a great pleasure to respond to the debate brought by the hon. Member for West Ham (Lyn Brown).

As the hon. Lady says, we have met to discuss this before, and I too extend my thanks to her constituent Jane, who has been incredibly courageous, despite living with a condition that is profoundly distressing for her to manage, in none the less using that in such a positive way. Frankly, the most important thing we can all do is to raise awareness of this disorder, and she is doing that beautifully and is incredibly articulate in how she does it. I pay absolute tribute to her; she has certainly put the disorder on my radar, so I am delighted to have the opportunity to discuss it in the House and do our bit to raise awareness, because, as the hon. Lady has mentioned, eight to 12 years before getting a diagnosis is not good enough.

The reason people wait so long is that this is a disorder that is not understood, but it is also fair to say that many personality disorders are misunderstood. We tend to lump mental ill health and disorders together, but they require to be treated in very different ways. Often, when it comes to disorders, medication is not the best solution, so it is important that we get diagnosis right and the way we will do that is by raising awareness of what is, as the hon. Member for Strangford (Jim Shannon) said, a very common condition. Many of us may have had out-of-body experiences when we are going through something unpleasant, because that is how the body naturally copes with trauma, but when people are going through sustained trauma, as many sufferers of DPD have, it becomes a way of dealing with life.

The worst thing, as the hon. Member for West Ham highlighted, is that that can often be brought on by drug use. I do not think we should be squeamish about mentioning that. We have a debate going on about drugs at the moment that is all about, “We have lost the war against drugs; it is all done through the lens of crime and disorder.” The reality is that the extent of cannabis use in this country is contributing to our mental health crisis—of that I have no doubt—and I do not think we should be squeamish about saying it, so I am grateful to the hon. Lady for giving me the opportunity to do exactly that.

We must ensure we do better. Last year, I had the great privilege of chairing the women’s mental health taskforce, and I saw that we are seeing a greater scale of mental ill health being experienced by women between the ages of 16 and 24. We put trauma at the root of much of that, and we have a strategy to roll out much more trauma-informed care across the NHS, which I hope will also extend to raising greater awareness of this disorder.

The hon. Lady’s point about making GPs and practitioners more aware of this disorder during their training is very good. We—collectively, as a system—need to think what more we can do to educate the whole NHS about the difference between severe mental ill health brought on by other conditions, things that are brought on by, for example, trauma, and the whole issue of disorders. We should not just medicalise treatment through prescribing drugs but should put together wraparound support and care, giving people the tools to manage what are often debilitating conditions.

As I said, I greatly enjoyed meeting Jane and the clinicians from the South London and Maudsley NHS Foundation Trust last year, where I was given a compelling presentation. We need to explore this condition more, so that we get this right. Its triggers are poorly understood but may be related to previous trauma, as we have heard.

The hon. Lady asked for more support through CAMHS. A lot of this trauma starts and is sustained in childhood. An important tool in spreading awareness of this disorder will be the new children’s mental health teams that will go out into schools. We are looking for mental health leads within schools to refer children that they sense are having difficulties, so that we can intervene early to support them. We know that the longer people live with this ongoing trauma, the harder it is for them to manage. Without going into individual cases, because it is very distressing for the people involved, I am certainly aware of cases of adults now living with this disorder having gone through sustained trauma in childhood. We clearly need to find a way of dealing with that.

We have come a long way in breaking down mental health stigma and raising awareness of different conditions, but I repeat that there is a real lack of awareness about disorders. We now talk broadly about bipolar disorder or borderline personality disorder, but do people really know what they mean? I do not think so. We need to spin our education around that. As the hon. Lady mentioned, at the moment only one clinic specialises in this disorder. Partly because of the lack of awareness, it is fair to say that the research evidence on what works to treat this disorder is still at a very early stage. Obviously, the NHS will support further investment in those treatments based on evidence. We lack National Institute for Health and Care Excellence guidelines for the treatment of DPD. That must be on the do-to list.

Essential to that support will be finding out more about this disorder. This is a learning process for everyone, and people like Jane obviously contribute massively, but it is for clinicians and researchers to do their best and really get to grips with what will be required. I acknowledge the world-class work being undertaken at the Maudsley clinic, which is one of the leading research and clinical treatment units in the world for this condition. It has pioneered an incredible service, which Jane praised to the hilt for what it has done for her health. It really works to improve health outcomes for patients and is dedicated to expanding the understanding and treatment of depersonalisation through its research, which I encourage, because further research is vital to improving our understanding of the prevalence of this condition and its treatment.

The Maudsley clinic has successfully assessed more than 500 people since the inception of its service, which is amazing, but as 2% of people suffer from it, there is more to do. It also works closely with the research unit at King’s College London, which adds to that understanding. Clearly, waiting nine to 12 months for therapy after diagnosis is not good enough, so I am pleased to say that the Department held an initial roundtable meeting at the end of last year to hear about the work of the service provided by the trust and to discuss current research into those treatments and suggestions on NHS management of the condition. We look forward to taking that work forward. We also discussed options for next steps with the Maudsley clinic, including its applying for a development grant from the mental health policy research unit of the National Institute for Health Research.

I understand that the team at the specialised unit at the Maudsley clinic has faced challenges in acquiring such funding in the past. It is tricky: we need evidence to get the money for research, but money for research is needed to feed the evidence. I completely understand that. However, I say to the hon. Lady that the Department’s research team will discuss with the unit the most appropriate type of research funding for it to bid for. Clearly, we want to make sure that we make the most of its expertise and expand our understanding of this condition. I hope that that brings some reassurance. I look forward to seeing further developments in this space.

[Lyn Brown]

As always, I am delighted by what the Minister has offered us, especially on research, which is fantastic. I thank her for that. However, I would not be me if I did not press her on the three things on my list that she has not mentioned—writing to the presidents of the Royal College of General Practitioners and the Royal College of Psychiatrists, introducing a programme of training for mental health trusts and improving access to treatment for under-18s. I am happy for the Minister to write to me on those.

[Jackie Doyle-Price]

I would like to take that away and discuss with the NHS clinical lead how best to do those. I agree with the hon. Lady, but I will look at this in the broader context of disorders and really getting that understanding of severe mental health conditions and ongoing disorders, which need different tools. However, I will write to the hon. Lady, and I know that we will continue to have dialogue on this issue.

In conclusion, I readily acknowledge that there is still a lot of work to be done to support people with this disorder and to help them to make a full recovery with treatment and support. I assure the House that that is very much on my to-do list. I look forward to having further dialogue with the hon. Lady and Jane, who I wish every success in managing her condition. I hope I have provided sufficient reassurance that we are committed to doing what we can for these people.

Question put and agreed to.

Draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 Draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Jackie Doyle-Price Excerpts

Wednesday 6th March 2019 General Committees

[The Parliamentary Under-Secretary of State for Health and Social Care (Jackie Doyle-Price)]

I beg to move,

That the Committee has considered the draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.

[The Chair]

With this it will be convenient to consider the draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.

[Jackie Doyle-Price]

It is a great pleasure to serve under your chairmanship, Mr Robertson. In the event of a no-deal Brexit, I am confident that every Member of this House has a shared intention to protect and improve the safety of patients who use medicines and medical devices and, at the same time, enable access to the most innovative of treatments.

Our regulator, the Medicines and Healthcare products Regulatory Agency, otherwise known as the MHRA—not the last acronym that we will rely on this afternoon—has over 30 years’ experience as a key regulator in the EU. Its expertise and experience is recognised and respected globally, and we want to ensure that that continues to the benefit of UK patients. It is with that at the forefront of our minds that the UK’s plans for the regulation of medicines and medical devices in a no-deal scenario have been developed. Before I set out those plans, it is important to reiterate our real aim of retaining a close-working partnership with the EU to ensure that patients in the UK and the EU continue to have timely access to the safest and most effective medicines and medical devices through the co-operative network that we have built over the years.

As is described in the explanatory memorandums, the system for regulating medicines and medical devices is currently set out in EU legislation. The draft statutory instruments have been introduced to ensure that our national regulatory system continues to function appropriately in the event that the UK leaves the EU without a deal. In developing the regulations, the Department’s priorities have been to ensure that the timely availability of safe and effective medicines and devices continues, to minimise disruption to patients and businesses, and to ensure that the UK regulator is able to continue to protect public health.

Members will want to note that the draft regulations have been developed through continued close consultation and co-operation with stakeholders. After a period of informal consultation in August last year, the MHRA published an initial proposal for the UK medicines and medical devices regulation framework, before following that up with a four-week public consultation in October. The feedback of the 170 responses to that consultation led to revised proposals, which were published in January and informed the draft SIs.

I will set out some details of the arrangements and how we have sought to maintain continuity and minimise disruption. First, wherever possible, we have sought to maintain existing arrangements, which should obviously be the first port of call to ensure a smooth transition in the event that we leave the EU without a deal.

With respect to medicines, the UK regulator already operates a national licensing route. In fact, about 90% of medicines used by patients in the UK already have national licences, which will remain valid. The provisions deal with the outstanding 10% of medicines. In the event that the UK leaves the EU without a deal, it will no longer be a part of the European Medicines Agency. The draft regulations therefore provide for the automatic conversion into UK licences of all centrally authorised products and licences, to ensure continuity for patients. One such product is ritonavir, which is a drug for treating patients affected by HIV type-1. The draft legislation deals with specialist products that are not in the national licensing system.

With respect to devices, the UK is already a part of the EU system of conformity assessment for medical devices. That system sets out the standards for pre and post-market assessment of medical devices, and the MHRA is the competent authority within the UK. Those standards will not change, so the draft devices regulations will ensure that UK law aligns with EU regulations in this area after we leave. That is the straightforward part.

In other areas, we have faced a choice regarding the UK’s regulatory requirements, and in those instances have sought to maintain current arrangements while ensuring the regulator still has sufficient ability to protect public health. For example, we will continue to recognise batch testing of medicines in the countries we recognise today, which include those in the EU and European economic area. By that, we mean that by becoming a third country we would be seen as importing, rather than as part of the single market. If medicines have been tested by a trusted regulator, we would accept that testing.

We will continue to recognise the CE mark on medical devices and in-vitro diagnostics that have demonstrated their conformity with EU regulatory requirements. It is intended that that recognition will be time limited while we consider the need to revise the UK’s system of regulation, linked to the development of new international trading arrangements that the Government are now pursuing. However, any subsequent change would clearly need to be brought before Parliament. For the time being, we plan to maintain the existing arrangements.

There are a few areas in which it has been necessary to add a new requirement as a result of the UK no longer being part of the European regulatory framework. Examples for medicines include a new regulatory hurdle to ensure that medicines do not enter the UK supply chain without having been certified by a qualified person. We are creating a new position within the wholesale licence holder regime, known as a responsible person for import, or RP-I—not to be confused with another RPI. That person will be responsible for providing assurances that such certification is in place, which is a function of having to maintain a national regulatory system with integrity, given that we can no longer rely on the EMA regime.

We will ensure that all new medical devices and in-vitro diagnostics being placed on the UK market are registered with the MHRA by establishing a new national database for all devices. Obviously, that will be a new cost for business, and the fee will be £100. Manufacturers based outside the UK will be required to have a UK-based responsible person who acts on their behalf to carry out specific tasks, such as registering with the MHRA. There will be a transitional period to enable the industry to implement those requirements.

In conclusion, in the event of a no deal, these draft regulations will put in place a pragmatic solution that ensures the UK’s medicines and medical devices regulation legislation continues to function effectively after exit day. The provisions will minimise any impact on patients and businesses and ensure the timely availability of safe, effective medicines on the UK market.

--- Later in debate ---

[Jackie Doyle-Price]

I thank the hon. Members for Ellesmere Port and Neston and for Central Ayrshire for their probing questions. They have both made compelling arguments. I recognise their concerns about scrutiny, but we are where we are. The Government have to make provision for a no-deal scenario, even though we remain determined to leave the EU on 29 March with a deal. None the less, we need to put these statutory instruments in place to deal with the event that that does not happen. Both hon. Members asked probing questions, and I shall try to address all of them. I am sure I will miss some, but I promise to write to them both with full answers to the points they have raised.

Overall, there are concerns about the costs to businesses, patients and taxpayers, all of which need to be addressed. However, I should be up front about this. Clearly, there will be a cost to business. One reason why Margaret Thatcher was such a big believer in the single market was that a single-market regime would reduce costs to business. Therefore, unilaterally leaving the single market will increase costs. We need to be frank and honest about that. We also need to be frank and honest that some of those costs will be passed on to taxpayers and patients. That is a given, but it underlines why we are determined to leave with a deal and minimise any disruption, recognising that we want to make the best out of this scenario for Great Britain.

Some issues were also raised about resources and personnel in respect of the MHRA, which I will come on to. I appreciate that hon. Members feel that they have not had sufficient opportunity to scrutinise this. However, I can assure the Committee that the proposals have been taken forward by MHRA in full consultation with business with a desire to minimise disruption and additional cost, and with a full view to planning to ensure that MHRA is equipped to deal with it. Much of the machinery is in place, given MHRA’s role in being such a key player within the EMA.

As I mentioned in my opening remarks, the Government’s approach has been to minimise burdens on business while enabling the most robust action for the UK to protect public health. As I have said, I acknowledge that that will place costs on business. The hon. Member for Central Ayrshire explained the disproportionality of EMA costs with regard to what might be replicated with the MHRA. She is absolutely right about that. I can tell her that the fees have been developed based on existing processes. For example, the targeted assessment fee is based on the existing MHRA incoming mutual recognition fee. Furthermore, the MHRA regularly reviews its fee levels and will continue to do so. There is a commitment from the MHRA to review the overall system of fees to the industry following exit with no deal so that we can maintain that they are fair and proportionate to business.

[Dr Whitford]

Obviously, the MHRA uses a trading fund now and must basically wash its own face financially. Will the Government provide more direct funding to the MHRA or is it envisaged that all of the costs will still be recouped from fees?

[Jackie Doyle-Price]

On day one of exit under this scenario, the MHRA will, as the hon. Lady says, continue to wash its own face. As to what might materialise subsequently, that would be subject to further discussion. I would not rule out anything at this stage. We are trying to ensure that the business can continue as usual on 30 March if we leave without a deal, but—let us set this in stone—that is if that is the result on 30 March. If we end up in that scenario, we will of course want to make sure that we have got things working effectively. It is also true that we will have to see how relationships work in practice. We can already see that some market practices are preparing for a no deal; others are not. We have said what we are prepared to do to recognise what has happened and what is licensed and goes through the regulatory system in Europe. We are being quite open about accepting that.

The hon. Lady mentioned batch testing, for example. We cannot be sure the same will happen in Europe. We will have to monitor how that works out in practice before setting in stone what the future regulatory regime will be. I come back to my original point: this is for day one of exit to keep the show on the road.

[Dr Whitford]

The Minister talks about preparing for a no deal, but as the EMA does not have associate membership, most of what is being put in place will be required, deal or no deal.

[Jackie Doyle-Price]

That is right. As I have said, we are seeing that some parts of industry are preparing for that scenario on the basis that there will be no associate membership. Having left in that scenario, if we look broadly at how the MHRA discharges its functions and how it is funded, at this stage we are looking at it continuing as usual and washing its own face. The hon. Lady mentioned that we could use some of the Brexit dividend to meet the cost. All of that is completely wide open at this stage. This measure is really just to keep the show on the road.

We have put some expectations down in terms of review. Most of the commitments we have made are to review all of the operations within two years. As for any conclusions we reach, we will come back to Parliament to institute any change if that is what we wish to do, but that would be done very much in consultation with industry and in a transparent way, recognising that all Opposition Members are not entirely satisfied. Clearly, we will go back to business as usual when it comes to scrutiny of these matters. Again, I cannot say often enough that I do not want that eventuality to materialise. It is my determination that we leave with a deal.

There was a reference to the impact on SMEs. The MHRA is taking steps to ensure that the burden on them is minimised. It will look at things such as fee waivers for some products to encourage further research and innovation. Again, that recognises the real concern about that.

[Justin Madders]

I know that we have asked a lot of questions, but there is almost a contradiction in what the Minister has just said. She expects the MHRA to wash its own hands still, but talks about fee waivers in some circumstances. If it is a trading fund, and there are new obligations on it, I am not sure how all that will realistically work.

[Jackie Doyle-Price]

I trust the MHRA to manage its own finances and take a proportionate view as to what is an appropriate fee, because it has the day-to-day contact with businesses. Overall, it will still be expected to settle its budget on the basis of the fee income that it incurs. That still gives it the freedom to do that, if that is in the sector’s strategic interest.

We have responded to some of the representations made by business about the potential additional costs. One reason that we introduced the responsible person for import assurance procedure was to minimise, as effectively as possible, the burden on the trading of the wholesale sector. Again, that recognises that where things have been checked and have gone through an appropriate European regulatory procedure, we should be satisfied that that is good enough for us. I am confident that that pragmatic approach will be repeated as the MHRA takes the matter forward.

Several points were made about the MHRA’s ability to take on new roles. The UK already has substantial capacity and expertise to regulate and evaluate the safety of our medicines and medical devices. The MHRA has real expertise in many areas, including pharmaco- vigilance and clinical trials regulation, which provides benefits to patients across the EU. I am confident that the EU will want to retain access to that expertise. That also shows that the MHRA has the expertise and human resources to discharge those roles. It has 30 years of experience as a lead regulator, it has led on the registration of more than 3,500 medicines, and it is globally recognised for its expertise. None the less, it will manage the demands on its service and I have every confidence in its ability to do so.

The hon. Member for Ellesmere Port and Neston raised the issues of continued access to medicines and of reviewing the fees. The statutory instrument provides continuity for patients and businesses by providing for existing EU licences to be automatically converted into UK licences, which should give continued access to medicines and will be done at no cost to industry. It also puts in place a new licensing route that will allow the MHRA to accept the same information from companies that apply for an EMA licence and that will allow the UK to grant a licence in the same timeframe as one would be received today.

Effectively, we will follow and replicate what the EMA does. There has been much talk of the UK being rule takers and hon. Members might suggest that there is no change here. That recognises, however, that we are in a global marketplace for medicines and that we all want to have access to the best medicines. In practice, there is much shadowing and sharing of expertise in this area. That raises a question that we do not have time to debate this afternoon, but there is much to be gained from international co-operation in this area.

Obviously, we want to make sure that the UK remains an attractive market for new medicines and for innovation. As I said earlier, we will review the fees set out in the SI within two years to make sure that they remain competitive and fit for purpose, and that they deliver the objectives that we want to achieve through the regulatory system.

The hon. Gentleman laid down a challenge; he said that the regulations go beyond a simple technical implementation of the directives into UK law and raise new powers for the Secretary of State. Clearly, the regulations are made under section 8 of the European Union (Withdrawal) Act 2018, which gives Ministers powers, where appropriate, to take additional powers. However, the changes are the minimum necessary to maintain continuity while protecting the health of UK patients while we are outside the EU, although clearly there is concern about issues of supply, as the hon. Member for Central Ayrshire mentioned.

We do not anticipate needing to use the Henry VIII power. We are confident that the regime that we have set out will ensure continuity of supply. However, in the event that that did not happen, provision would be needed. The power is a safeguard to be used in the case of serious shortages. I would not choose to describe it as a Henry VIII power, but I recognise the right of Opposition Members to do so. It is limited to temporarily modifying the effects of the human medicines regulations, for a limited time or purpose. As has been mentioned, the statutory instrument would use the negative procedure, but it could obviously be annulled. However, it would be used only where existing processes had been exhausted.

The hon. Member for Ellesmere Port and Neston raised the question whether any particular medicines would be at risk, and also mentioned prices in that regard—a concern that I think the hon. Member for Central Ayrshire will share. Clearly the MHRA consulted on the issue, and that informed its analysis. Any potential increase in medicine prices will depend on the extent to which costs are passed on to the consumer; but we shall bear the matter in mind, with regard to future medicines price negotiations. It is something that we shall have to keep an eye on at this stage. It is difficult to quantify. None the less, we have made clear commitments to the public about what they can expect, and about ensuring a continuous supply of medicines, and we shall have to find ways to deliver on those commitments.

[Dr Whitford]

Is the Minister aware that the Royal College of Radiologists has now produced emergency guidance to nuclear medicine departments, simply because the UK Government did not, on the potential threat of shortage of radionuclides and radiopharmaceuticals, both for scanning and for cancer treatment?

--- Later in debate ---

[Jackie Doyle-Price]

I was not aware of that, but I encourage everyone to participate in the dialogue, because in such an event the whole system would need to be ready. I shall perhaps come back to the hon. Lady on that specific point because, although much of our no-deal preparation is happening within the confines of Whitehall, it is not all being shared publicly.

I emphasise that there have been massive conversations with industry, including those in the life sciences industry—and with charities—about the changes, to make sure that everyone is prepared.

[Dr Whitford]

The Minister says that preparation is happening in Whitehall that is not being shared with the public, but we are talking about the president of the Royal College of Radiologists. The people who actually deliver scans have not had any guidance from the Government. That is not scaremongering. They have to be ready for something that could happen in a few weeks. They are talking about delaying patients, planning light weeks, and when the molybdenum will arrive, because those things cannot be stockpiled. Why has there not been guidance to the NHS about how to prepare to deal with shortages of radionuclides?

[Jackie Doyle-Price]

My understanding is that those conversations have been taking place. However, the hon. Lady is right that the very nature of those products, which cannot be stockpiled, has brought complications. I fully expect the president to be involved in those conversations. I do not have that knowledge to hand now, but I will write to her afterwards, to give her some reassurance.

We had two waves of consultations on the draft instruments. For the last, in October, we issued a consultation that received 170 responses, through which we ended up with the proposals before us. Again, these are subject to further consultation with the industry.

It is obviously a priority for us to make sure that Britain remains a competitive location for life sciences companies, and we are committed to maintaining our renowned strength in science and research. Since the referendum, we have seen many signs of the industry’s continued confidence in the UK. In 2017, we received the highest level of life science investment in Europe, and were second globally only to the US. That illustrates the confidence in our regulatory system, which is why we are confident that the MHRA is well up to the task given to it by the draft statutory instruments.

The hon. Member for Ellesmere Port and Neston gave an impressive illustration of what he described as the confusion regarding the various dates at which parts of the draft regulations will come into effect and the complexity of some of the references within them, and he posed legitimate questions on how business would understand and prepare for them. However, as I say, we have produced detailed guidance to support everyone in interpreting the draft instruments, and the MHRA does not expect anyone to navigate this alone and will be there to give advice. That support is partly reflected in the length of time that businesses will have to prepare for and implement these measures. We will ensure that that dialogue continues.

The hon. Gentleman also raised questions about market access and legal accountability, and whether we will have sufficient people to discharge that role for the industry. We believe that those skills are already in place, bearing in mind that a lot of companies will already have to fulfil these functions with the EMA, particularly when exporting. We do not anticipate that this change will be disproportionately onerous on business. However, we have given the industry 21 months to implement that aspect. To make sure that only genuinely qualified people undertake that role, anyone who vouches for a medicine that is then potentially harmful to patients faces a maximum two years’ imprisonment. The sector has sufficient integrity to engage only properly qualified people; to do otherwise would be foolhardy.

Questions were asked about the degree to which UK consumers could be protected from false medicines. To reassure Committee members, the falsified medicines directive, implemented in 2013, will remain in UK law, even in the event of a no-deal exit. We will make sure that we continue to apply the same protections as before. We obviously want to retain a close working partnership with the EU on medicines regulation, and I think that we will be able to share expertise and information on such issues over and above any potential mutual recognition of regulations. We will all benefit from that information sharing. Issues were also raised about the wholesale sector. We will obviously continue to ensure that the MHRA keeps a good eye on that and makes sure that that regulatory regime is fit for purpose.

Turning to some of the comments about the devices, we will continue to recognise the CE mark on medical devices. It is also fair to say that the existing regulatory regime has perhaps been seen as rather liberal in its approach—the hon. Member for Central Ayrshire alluded to this when she referred to mesh—and it has been subject to some revision at EU level. Certainly, we want to follow what is happening with that review and consider whether there are any further improvements we would wish to make to that CE mark system.

To those colleagues who thought that leaving the EU might lead to a bonfire of regulation, I say that, clearly, when it comes to medical devices, some of which remain within the body for a length of time, we should not stint in our approach to the protection of patients. Patient safety should be the primary objective, notwithstanding the importance of maintaining a competitive marketplace. Patient safety is crucial.

There are estimated to be around 600,000 medical devices available on the EU market, many of which have not been produced in the UK or approved by UK-notified bodies. It would be quite a big undertaking for the MHRA to license those products, but we will increase our market surveillance by requiring all new devices being placed on the UK market to be registered with the MHRA after exit day by the manufacturer or a UK responsible person, in accordance with the transitional timetable. Our emphasis is patient safety first and foremost, while doing our best to improve access to the market. We will require, as the hon. Member for Ellesmere Port and Neston said, all overseas manufacturers to register those products here with the MHRA themselves.

We have also had some discussion about the RP-I. That is a new role; the hon. Gentleman asked how many will be required and where we will find them. We are giving the industry a two-year transition period, to give it the opportunity to register those persons with the MHRA, and it will depend on the number of wholesalers who intend to import products from the EEA. We are satisfied on the basis of the discussions we have had with the industry that that two-year implementation period is appropriate, and there has been consultation on exactly what sorts of skills those persons should have, with the intention that they should fill the regulatory gap caused by our removal from the EMA, but without putting undue burdens on the industry.

[Justin Madders]

In essence, the Minister is saying that, having consulted the industry, the general view is that there will be sufficient people in place with the right skills within 21 months. If that is the case, that explains the position, but is there a fall-back position if that does not transpire?

[Jackie Doyle-Price]

As I say, that timescale has been arrived at between the MHRA and the industry. On that basis, I would not anticipate a problem, but we will have to monitor that none the less, bearing in mind that we are effectively introducing a new regime and any market adjustments that happen in that intervening period will have an impact on it. A lot can happen in those 21 months. We are effectively altering the terms of trade, and we cannot be sure of all the consequences of that, but the MHRA will maintain that close dialogue with the industry to ensure that we are being sufficiently responsive.

The hon. Gentleman also mentioned the national database of all devices. The fee for establishing that database will be £100 for each device. Manufacturers outside the UK will be required to have a UK-based responsible person, who would act on behalf of that manufacturer to do things such as registering the product. Again, there will be a transitional period to enable the industry to implement those changes.

Some questions were asked about access to medicines. Obviously, we want to make sure that UK patients have access to life-transforming drugs at the same time as people in Europe. Whether we might be placed at a disadvantage by being outside the EMA has been a real concern. We want to ensure that when a drug is registered with the EMA, we consider it at the same time, so that there is no advantage for any manufacturer in delaying entering the UK market because it would not get any ongoing benefit from that, in terms of protective rights on intellectual property. We would effectively start the clock at the same time as the application with the EMA to give an incentive to enter the UK market as soon as possible. Again, we will wish to monitor how that works in practice.

We will assess whether countries from which a registered importer operates might change over time, and whether that needs scrutiny by Parliament, on the basis of whether the technical standards in that country are consistent with ours. Obviously, that would be a constantly moving feast. The MHRA is ideally qualified to make a judgment on that, but I would expect it to do that with sufficient transparency to allow any challenge to take place.

I apologise if I have not addressed all the points that have been made this afternoon. I will write to hon. Members. I reassure all hon. Members that the Government are fully committed to a system of medicines and medical device regulation that intelligently balances patient access to new, innovative and world-leading projects. As part of these measures, the MHRA will have in place a suite of licensing routes for medicines and vigilance systems for medicines and devices. The Government also place enormous value on the contribution to public health of the research charities, industry and the life sciences sector as a whole, and as such, the MHRA will continue to support innovation in the life sciences through its innovation office and scientific advice.

We remain committed to offering a competitive regulatory environment to ensure that the UK has access to the safest and most effective medicines in the world. As I said, we have tried to replicate the current regime, but there has been a need to add additional requirements for industry to deal with the fact that we are leaving the EMA and its regulatory structure. We have done so in the most competitive way possible, while maintaining patient safety and remaining the best place in the world for science and innovation.

Question put and agreed to

Resolved,

That the Committee has considered the draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019.

Draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019

Resolved,

That the Committee has considered the draft Medical Devices (Amendment etc.) (EU Exit) Regulations 2019.—(Jackie Doyle-Price.)