Black Maternal Health Week

Nadine Dorries Excerpts

Tuesday 14th September 2021 Westminster Hall

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

It is a great pleasure to serve under your chairmanship for the first time, Mr Hollobone. I thank all Members who have taken the time to attend the debate, in particular the hon. Member for Streatham (Bell Ribeiro-Addy), who I have heard speak before about her experience on this issue. I think she is incredibly brave to campaign and highlight the issue in the way she does. I thank her for her thoughtful considerations. I know that she is holding my feet to the fire as well as the Department’s, and that is a huge assistance in pushing the agenda forward within the Department of Health and Social Care.

I stand responding to the debate as a brand new grandmother of 18 days. The delivery was not uneventful, and the baby arrived early, which is a similar story to that of the hon. Member for Vauxhall (Florence Eshalomi) at St Thomas’. Having given birth myself three times, I understand in a very raw way the pressures that all women experience, and I lived through just two weeks ago how emotional and incredibly frightening it can be when things do not go to plan.

This is the second annual awareness week we have had to highlight the disparities for black women in maternal health outcomes in the UK.

[Florence Eshalomi]

Congratulations to the Minister, it is always a joy to see more children and grandchildren. I am still getting to grips with motherhood with my four-year-old and six year-old. The statistics clearly show that the maternal death rates, and negative experiences, of black and Asian women are higher, but this does not negate the fact that some white women also go through similar experiences. Does the Minister agree that improving the maternal health outcomes of one group will improve the outcomes for all groups?

[Ms Dorries]

The hon. Lady is absolutely right. I am very proud of the work that we have done in the Department of Health and Social Care, and in the NHS, to improve maternal outcomes for everyone, particularly over the last few years. The statistics speak for themselves. However, I will focus on the issue of black women and maternal health, because there is a great deal that we have done since the hon. Member for Streatham had the last debate. I am looking forward to informing her about the work that has been undertaken since then. I thank her for instigating this debate, and I hope that she continues to hold our feet to the fire. It is important that people do raise this issue, as she does, as often as possible in Parliament.

In response to the incredibly articulate speech by my right hon. Friend the Member for Romsey and Southampton North (Caroline Nokes), it is right to raise the report by the Health and Social Care Committee, which I will respond to next week. A number of the questions that have been asked today will be included in that response, so I will not steal my own thunder—I will wait to provide a response next week.

I thank the co-founders of the Five X More campaign, Clotilde and Tinuke, and all the health care professionals and organisations who campaign to raise awareness of this week. I have visited Tommy’s maternity unit three times now, and the hon. Member for Streatham is right to raise the point that the majority of staff, doctors and midwives are black. I am incredibly impressed with the way that Tommy’s addresses this issue; they are pioneers in addressing maternity inequalities and outcomes, and they do fantastic work. I pay tribute to Tommy’s, and all hospitals, who I know are putting their weight behind reducing maternity inequalities and outcomes—Tommy’s is certainly at the forefront of that work. My granddaughter was born at Chelsea and Westminster hospital, so I thank them too—they are pretty amazing as well.

This debate comes a few days before this year’s World Patient Safety Day; the theme this year is safe maternal and new born care. It provides an opportunity to mark the progress made across the system in improving outcomes and safety, but also to recognise that further work is needed. At its best, NHS care offers some of the safest maternal and neonatal outcomes in the world. However, the disparities that exist between black and white women in pregnancy and childbirth experiences are unacceptable. I am committed to both reducing this disparity in health outcomes, and improving the experience of care.

We cannot beat around the bush any longer on some of the reasons why we experience these inequalities. They are complex, and there is no one answer as to how we can address this subject. Personal, social, economic and environmental factors all play a part; we must address the causes of disparities to improve outcomes and experiences of care. I was delighted that last week NHS England and NHS Improvement published their equity and equality guidance, which responds to findings that maternal and perinatal mortality show worse outcomes for those in black, Asian and mixed ethnic groups. They invested £6.8 million in the guidance to improve equity and equality action plans, and implement targeted and enhanced continuity of care.

We know that pregnancy lasts around 40 weeks. However, when a woman walks into a hospital to give birth, those 24 or 48 hours—however many hours she is in hospital—are not what wholly contributes to her experience of the healthcare sector, or her outcome. A lifetime approach is needed to address some of the reasons why some women are more at risk of poorer outcomes than others. We know that there are many health issues that contribute to poorer outcomes in pregnancy, including alcohol, obesity and smoking. The chief medical officer recently published a report that showed that, in some of our seaside towns, 25% of women are smoking at the beginning of pregnancy. I think the figure was that 22% were still smoking by the end of their pregnancy. There are inequalities and health disparities that we really need to address.

For that reason, we have established the newly formed Office for Health Improvement and Disparities, which launches on 1 October, to target those health disparities, including racial and ethnic disparities in health, and to improve pre-conception health to support women to be in their best health throughout pregnancy.

[Ms Abbott]

rose—

[Ms Dorries]

I will just finish the point on the office of disparities, because it is quite important. It is a huge step to establish an office that will actually deal with this particular issue. It will tackle inequalities across the country, and will be co-led by the newly-appointed deputy chief medical officer, Dr Jeannelle de Gruchy.

The office will be a vital part of the Department of Health and Social Care, and will drive the prevention agenda across Government to reduce health disparities. I hope the hon. Member for Streatham welcomes the establishment of this new body to tackle the top preventable risk factors for poor health, which include obesity, unhealthy diets, lack of physical activity, smoking and alcohol consumption. Equity and equality guidance will also be issued.

It is a huge step to look at those lifetime health experiences that contribute to what happens at the point of delivery and throughout pregnancy. Until we improve, and look at what happens before, using a lifetime view of health that includes women’s experiences of health throughout, then tackling what happens when they walk through a labour ward door will continue to be very difficult.

[Ms Abbott]

I think everyone present welcomes the establishment of the new office. The Minister has mentioned obesity, alcohol and smoking as risk factors in pregnancy; I take it she is not suggesting that the disproportionate outcomes we have for black women are because we are more likely to be obese, smoke or drink.

[Ms Dorries]

No.

[Ms Abbott]

I just wanted to get that clear.

[Ms Dorries]

Absolutely. The office will look at all pregnancies, and the negative contributing factors. I believe that one in four women—black and white women—who present in labour are obese. That has an incredibly high risk factor during labour, so it is to address inequalities across the board. My right hon. Friend the Member for Romsey and Southampton North mentioned socio-economic groups, and the disparities they experience: smoking, alcohol and other negative factors that contribute during pregnancy are across the board, and they need to be addressed. That is the reason why the office has been established.

The cessation of smoking during pregnancy was something we campaigned on a lot in the past. I have noticed, probably since we passed the legislation to ban smoking in many places, the emphasis has almost come off the importance of not smoking during pregnancy. The CMO’s report highlights that, in some areas of low socio-economic grouping, 25% of women are starting pregnancy smoking. That highlights the fact that we need to put more emphasis on, and focus on, those health disparities.

[Anne McLaughlin]

Maybe I am misunderstanding, but this Office for Health Improvement and Disparities is going to look at things like smoking—you can stop smoking and can be supported in that, and you can stop drinking and can be supported in that—and I think all this is really good, but people cannot change their skin colour. Will it be looking at how ethnicity impacts on women’s and babies’ chances?

[Ms Dorries]

Absolutely—across black, Asian and mixed ethnic minority groups as well. The point has been made today that black women do not feel listened to. We hear stories of complaints about pain, prolonged labour and other issues, and black women just do not feel as though they are being listened to in that environment. The core finding of the Cumberlege report, which addressed mesh, sodium valproate and Primodos, was that women are not being listened to, and black women probably even more so in the maternity setting. That issue for women, black women, Asian women and women from mixed ethnic backgrounds needs to be addressed. Women have to be listened to.

Turning to covid-19 and vaccinations, covid-19 has further exposed some of the health and wider inequalities that persist within our society. While considering disparities in the context of the pandemic, initial data suggests that vaccine uptake among ethnic minorities is lower than for other groups. Covid-19 vaccines are recommended in pregnancy. Vaccination is the best way to protect against the known risks of covid-19 for women and babies, including admission of the woman to intensive care and premature birth of the baby.

New findings from a National Perinatal Epidemiology Unit-led study showed that of the 742 women admitted to hospital since vaccination data has been collected, only four had received a single dose of the vaccine and none had received both doses. That means more than 99% of pregnant women admitted to hospital with symptomatic covid-19 are unvaccinated. That is quite stark.

[Caroline Nokes]

On that point, will my hon. Friend reassure me and all Members that the Government will keep pushing the crucial message that the vaccine does not affect fertility or pregnancy, and that it is important for pregnant women and women of childbearing age to get the vaccine?

[Ms Dorries]

Absolutely. My right hon. Friend has done it for me, but I absolutely encourage women to get the vaccine because 99% is a huge figure. There is a basis of mistrust. The reason why many black women do not access some of the health services they should do before pregnancy is because they do not feel listened to and they do not feel they can trust their practitioner. The message of “Take the vaccine” must be pushed.

I will finish by taking the opportunity to urge women to continue to access maternity care and to stress that pregnant women should never hesitate to contact their midwife, maternity team or GP, or to call NHS 111 if they have any concerns. That also applies if parents are worried about their health or the health of their newborn baby. I urge expectant mothers to have their covid-19 vaccination as soon as possible. I do not think we can give out that message often enough.

[Bell Ribeiro-Addy]

I will try not to take up too much time. I am pleased we have had such a full discussion this morning. I know many Members across the House wanted to participate, but were unable to attend. I take confidence in knowing there are many Members in the House who are committed to reducing racial disparities in maternal healthcare.

I want to start by thanking Members who have contributed to the debate and I apologise for any mispronunciations of constituency names. Starting with some simple ones, I thank the hon. Member for Cities of London and Westminster (Nickie Aiken) and the right hon. Member for Romsey and Southampton North (Caroline Nokes) for pointing out how much black women do not feel listened to. The fact about socioeconomic groups was key. I also thank them for pointing out that, because of racism that exists in our society, 70% of black people in this country live in the poorest areas. That definitely has an impact.

I thank my hon. Friend the Member for Vauxhall (Florence Eshalomi) for sharing her experiences. It will be of great encouragement to her to know that St Thomas’ Hospital where she had her two wonderful children—they are my mates—has undergone five times more training than others and many of the midwives have done it, which is great. There are other NHS trusts like Croydon Health Services NHS Trust, which has put together a campaign called HEARD that is meeting these needs, taking steps and training in the gap where it has not been asked to train, and it should be congratulated for that.

My right hon. Friend the Member for Hackney North and Stoke Newington (Ms Abbott) made the point that we cannot blame black women for the situations that they find themselves in. Sadly, that is what happens, regardless of confidence, education and socioeconomics. As my right hon. Friend rightly pointed out, this does not always change outcomes, something which the hon. Member for East Renfrewshire (Kirsten Oswald) also pointed out.

I thank the hon. Member for Glasgow North East (Anne McLaughlin) for her frank comments about race and the articulate way in which she described exactly what institutional racism is. If only we had that level of understanding right across the House, I believe that this country would be a different place.

I also thank the Minster for her response and congratulate her on the birth of her grandchild. I thank her for committing to ending racial disparities. I think that this new body sounds like a positive thing, but I am concerned that, despite the new body and what it is going to tackle, it is still unclear whether the Government have understood that institutional racism is a serious factor affecting these outcomes and have made a direct commitment to changing that, especially in the light of the race report.

[Ms Dorries]

I have intervened, Mr Hollobone, because I think we have time. I probably should have also mentioned the Maternity Inequalities Oversight Forum, which is due to meet again next week. I do not want to give the impression that the new office which we are launching on 1 October will replace all the other work and everything else that we are doing. The Maternity Inequalities Oversight Forum still meets and, on the question about how it informs policy, it works hand in hand with the board of equalities and disparities. As the hon. Lady knows, we also have the patient safety board.

I can assure her that at all meetings, when we talk about maternal inequalities, the situation is something which has to be addressed and turned around in whatever way we can. This is why the Office for Health Improvement and Disparities is being established. We have to turn around the dreadful, appalling figures which pertain solely and uniquely to black women’s experience of maternity. I want her to understand that all the rest of the work is still going on, because this remains a focus in the Department. I urge her to keep calling her debates and to keep raising the issue, because it helps to drive things forward and helps us to develop acceptable and welcomed policies. I thank her for recognising the work of the disparities and inequalities board; it is just another tool that we put into the box to help fight a much bigger problem that we have to solve.

[Bell Ribeiro-Addy]

I thank the Minister, but my main point was that while the work is ongoing, given what has been said in the past about institutional racism, will it be with a recognition of how it affects our various bodies, not least the NHS? Accepting that point, which many of us do not believe has been done before, is key to making sure that we get the outcomes that we need overall.

As many Members know, this topic is particularly close to me and is not always easy for me to talk about. Many of those engaged in the campaign to end racial disparity in maternal health care experienced the same thing. When we detail our past events and the experiences, we do not do so to gain sympathy. We do so to give a voice to the hundreds of black women each year who have similar experiences, and in the hope that our stories will help to spur the change needed so that black women no longer face negative outcomes and the negative treatment we so often face. Bringing children into this world should not be a matter of life or death. We have a duty here, particularly with what we are tasked to do every day in our work, not just for the mothers who do not survive the dangerous birth experiences but for the many who go on to experience trauma.

I hope that the Government have been spurred into further action. I will continue to hold the Minister’s feet to the fire, since she sounds as if she enjoys it. I call on the Government to do a lot more: to ensure that we have proper data collection; to increase the support available for at-risk women; to implement the recommendations of the Joint Committee on Human Rights report “Black people, racism and human rights”; to identify those barriers to accessing maternal mental healthcare services and increasing the accessibility of mental health services after miscarriage and traumatic maternal experiences; to engage with black women in improving their experiences of maternal health services; and to commission a review of institutional racism and racial bias in the NHS and medical education to address the learned stereotypes about black and ethnic minority women that impact us so much.

By committing to those steps, the Government can demonstrate that they are serious about tackling racial disparities. Members have heard me say it before, and I will say it again: the colour of woman’s or a birthing person’s skin should not have an impact on their health or the health of their baby. The sad reality is that in this country it does, and while the Government appear to hear and are making some headway, I really want them to listen. I believe that they will truly have listened only when we have those targets and those very clear mechanisms to end institutional racism in our health service.

Question put and agreed to.

Resolved,

That this House has considered Black Maternal Health Week.

Health Protection (Coronavirus, Restrictions) (Steps etc.) (England) (Revocation and Amendment) Regulations 2021 Health Protection (Coronavirus, Restrictions) (Self-isolation) (England) (Amendment) Regulations 2021 Health Protection (Coronavirus, Restrictions) (Self-isolation) (England) (Amendment) (No. 2) Regulations 2021

Nadine Dorries Excerpts

Monday 13th September 2021 General Committees

[The Chair]

I can confirm that we are quorate. Before we begin, can I encourage Members to wear masks when they are not speaking? This is in line with current Government guidance and that of the House of Commons Commission. Please also give each other and members of staff space when seated and when entering and leaving the room. Members should send their speaking notes by email to [e-mail]. Similarly, officials in the Gallery should communicate electronically with Ministers.

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

I beg to move,

That the Committee has considered the Health Protection (Coronavirus, Restrictions) (Steps etc.) (England) (Revocation and Amendment) Regulations 2021 (S.I. 2021, No. 848).

[The Chair]

With this it will be convenient to consider the Health Protection (Coronavirus, Restrictions) (Self-isolation) (England) (Amendment) Regulations 2021 (S.I. 2021, No. 851) and the Health Protection (Coronavirus, Restrictions) (Self-isolation) (England) (Amendment) (No. 2) Regulations 2021 (S.I. 2021, No. 864).

[Ms Dorries]

The regulations lifted most of the legal restrictions when we moved to step 4 of the road map on 19 July and eased the self-isolation requirements from 16 August to allow those who are fully vaccinated and a number of other groups to be exempt from self-isolation if they are the close contact of a positive case. These are significant milestones in our country’s journey as we learn to live with the virus. We have certainly come a long way since the Prime Minister set out the details of the Government’s road map out of lockdown in February.

Moving to step 4 and easing a huge number of restrictions was a great progress. It is testament to the grit and determination of the public and to the expertise and dedication of all those involved in our country’s response to the virus and the phenomenal vaccination programme.

The Government’s road map charted a cautious approach to easing lockdown, guided by the data rather than the dates. When we moved to step 4 on 19 July, most restrictions enforced in law were replaced with guidance. Businesses are now open across all sectors. All remaining limits on social contact have been removed and there are no restrictions on how many people can meet in any setting. We are seeing our communities thriving again, with familiar social, sporting and community events returning to our English summertime. It was wonderful to spend treasured time with family, friends and loved ones without legal restrictions on our social contacts.

While we are enjoying those freedoms, we know that this is not yet a return to normal. The pandemic is not over, and the virus will remain part of our lives. We must continue to act carefully to protect ourselves and those around us. The test, trace and isolate system remains one of our best defences against the virus and it is one of the key ways in which we can protect ourselves, our loved ones and our communities.

Owing to the steady progress we have made and the tremendous success of the vaccination programme, we have been able to make important changes to ease the self-isolation requirements from 16 August while maintaining vital measures to reduce spread of the virus. The amendments to the self-isolation regulations that we are debating today allow those who are fully vaccinated and a number of other groups to be exempt from self-isolation if they are the close contact of a positive case. That includes an exemption for close contacts who can evidence that they are unable to be vaccinated for medical reasons. That is because we recognise that some groups are not able to be fully vaccinated.

The exemption further includes close contacts of those under the age of 18. We know the risk of covid-19 to children is very low and there are also unquantified harms to children’s educational, emotional and social outcomes as a result of self-isolation. We have ensured that the amendment also provides for an exemption for individuals who have been named contacts who have taken part in, or who are taking part in, the Medicines and Healthcare Products Regulatory Agency’s approved trial for covid-19 vaccines.

Although the requirement to self-isolate has changed for those groups, it is still important that the close contacts of a positive case act with caution. Close contacts who are exempt from self-isolation are advised to take a polymerase chain reaction test as soon as possible to check whether they have the virus. They are also advised to consider other precautions, such as wearing a face covering in enclosed spaces and limiting contact with others, particularly those who are clinically extremely vulnerable. It is important to remember that anyone who develops symptoms should self-isolate immediately and take a PCR test. Anyone, whether double vaccinated or not, who goes on to test positive for the virus is legally required to self-isolate.

The measures allow us to continue to manage the virus proportionately and effectively. We know that self-isolation can be difficult. I sympathise with respect to the burden and the challenges that self-isolation creates. Since September last year, the Government have provided councils with £280 million to provide support payments to those who may face financial hardship as a result of self-isolation. Between March and September this year, we provided up to £100 million to councils to offer practical support to those who most need it in the community. We know that thousands of people have benefitted from that support.

We continue to review the self-isolation regulations and guidance, and shortly we will update Parliament on plans for autumn and winter. Although we are undoubtedly in a better place than when we embarked on the road map out of lockdown in February, I echo my earlier statement that this is not yet a return to normal. We must all continue to act carefully and to follow the latest guidance to protect ourselves and those around us—for example, by getting tested when showing symptoms and self-isolating if required, ensuring good ventilation when meeting indoors, and getting the vaccine.

While the lifting of restrictions and the easing of some requirements to self-isolate have been welcomed by many, I know that some people may feel nervous, particularly those who are immuno-suppressed or immuno-compromised. We continue to bolster our vaccine wall of defence against the virus and to follow the advice of the Joint Committee on Vaccination and Immunisation. We are now offering vaccines to 16 and 17-year-olds and extensive planning for a booster vaccination programme is well under way.

This is the biggest and most successful vaccination programme this country has ever seen. It is a staggering achievement that over 80% of individuals aged 16 or over in the UK have received two doses of a covid-19 vaccine. It is estimated that the vaccines have so far directly prevented more than 143,600 hospitalisations. Estimates of the direct and indirect impact of the vaccination programme suggest that the vaccines have saved more than 105,900 lives.

As we enjoy our hard-fought-for freedoms, we can look to the future with a sense of optimism. However, we know that the autumn and winter months will be challenging. We cannot rule out the possibility of the Government needing to take further measures to manage the virus during periods of high risk, including this autumn and winter. We will, as far as possible, avoid reimposing social and economic restrictions, but that cannot be ruled out entirely as they might be needed. We continue to monitor the situation closely, informed by the latest data and scientific evidence, to ensure that the NHS does not face unsustainable pressure.

Finally, I am sure members of the Committee will join me in extending immense gratitude to all those involved in the vaccination and the test, trace and isolate programmes—the NHS, the social care sector and wider support services, including the many volunteers who have helped us get to this point and who continue to support our country’s response in this next phase.

It is a matter of regret that we are debating the regulations only now. It was essential to introduce them at the earliest opportunity, and we have always been clear that restrictions would be in place only for as long as they were needed. The content of each step of the road map has the prior approval of Parliament and we debated the oral statements setting out the shape of step 4, as well as that announcing the move to step 4. As ever, I welcome the scrutiny of Parliament and the valuable contributions of hon. Members to that end. I commend the regulations to the Committee.

--- Later in debate ---

[Ms Dorries]

I was trying to look up some of the more specific answers to questions, particularly the one about children as vectors, or transmitters, in education settings. I will write to the hon. Lady with that answer, particularly on young children, but as she knows, children in school settings are vectors rather more than they display infection themselves. However, there are more specific answers, and I will get the data and the numbers to her.

I thank everybody who has attended the debate and thank the hon. Lady for her thoughtful contribution. As I mentioned in my opening remarks, the move to step 4 of the Government’s road map out of lockdown and the easing of self-isolation requirements are significant achievements that have been welcomed by many across the country. We have charted a cautious approach to easing lockdown. Normally, when I am in this place putting forward restrictions, I am beaten down by the Opposition, so it is interesting to be easing restrictions while still having to deal, quite rightly, with the arguments on the other side.

We have charted a cautious approach and we have been guided by the data. We have always been guided by the data in everything we have done with the aims of avoiding a surge in cases putting unsustainable pressure on the NHS and saving more lives. That is, fundamentally, at the root of everything we have done throughout the pandemic. Moving to step 4 does not mark the end of the pandemic, and our test, trace and isolate system remains essential in tackling variants of concern and ensuring we are not putting unsustainable pressure on the NHS. The UK has conducted more than 274 million covid tests and reached more than 15.9 million people who either tested positive or were in contact with someone who had tested positive, who may otherwise have spread the virus.

Sensibly adapting the self-isolation regulations to allow those who are fully vaccinated and a number of other groups to be exempt from self-isolation if they are the close contact of a positive case is an important step as we learn to live with the virus. These changes ensure self-isolation is targeted on those who have the virus or who are most at risk.

Throughout the pandemic, our objective has been to protect lives and livelihoods, and that remains our priority as we face the months ahead. We have moved to a new phase of the Government’s response to the pandemic as the country learns to live with the virus. It will continue to circulate at home and abroad, and this winter covid-19, combined with a resurgence of influenza and other respiratory diseases, may cause additional strain on top of normal winter pressures on the NHS. As the Government set out in the guidance “COVID-19 Response: Summer 2021”, we may need to take further measures to manage the virus during periods of high risk, including this autumn and winter. It is the job of a responsible Government to make the contingency plans for such scenarios, and we are doing just that.

The Government are assessing the country’s preparedness for autumn and winter, and, as part of that, will consider whether to continue or to strengthen public and business guidance. We will, as far as possible, avoid reimposing social and economic restrictions, but those cannot be ruled out entirely if they are needed. We will update Parliament on plans for autumn and winter shortly, and we will of course continue to keep the data under review and monitor the latest available science. We have always been clear: restrictions would be in place for only as long as they were absolutely necessary. We will keep any remaining restrictions under close review and remove them when it is safe to do so.

I recognise that, for some, the easing of restrictions is worrying, particularly those who are extremely clinically vulnerable or otherwise at greater risk from the virus. The Government advise that people should remain cautious given the continued risk. This is not a return to normal, as I said in my opening remarks. While cases are high, everybody needs to continue to be cautious and to make informed decisions to manage the risk to themselves and to others. I think that speaks to the hon. Lady’s question about public transport and the wearing of face coverings.

I once again thank everyone for the sacrifices they have made over this period despite the hardships covid has imposed. Everyone has continued to act carefully and proportionately to manage the risks to themselves and to others. I would like to take a moment to reflect, as I did earlier, on the tremendous efforts and achievements of everyone involved. I commend the regulations to the Committee.

Question put and agreed to.

HEALTH PROTECTION (CORONAVIRUS, RESTRICTIONS) (SELF-ISOLATION) (ENGLAND) (AMENDMENT) REGULATIONS 2021

Resolved,

That the Committee has considered the Health Protection (Coronavirus, Restrictions) (Self-isolation) (England) (Amendment) Regulations 2021 (S.I. 2021, No. 851).—(Ms Dorries.)

HEALTH PROTECTION (CORONAVIRUS, RESTRICTIONS) (SELF-ISOLATION) (ENGLAND) (AMENDMENT) (No. 2) REGULATIONS 2021

Resolved,

That the Committee has considered the Health Protection (Coronavirus, Restrictions) (Self-isolation) (England) (Amendment) (No. 2) Regulations 2021 (S.I. 2021, No. 864).—(Ms Dorries.)

Essex Mental Health Independent Inquiry: Terms of Reference

Nadine Dorries Excerpts

Monday 6th September 2021 Written Statements

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

On 21 January 2021, I announced the establishment of a non-statutory, independent inquiry into the circumstances of mental health in-patient deaths at the former North Essex Partnership University NHS Foundation Trust, the former South Essex Partnership University Trust and the Essex Partnership University NHS Foundation Trust, which took over responsibility for mental health services in Essex from 2017.

I am pleased to inform you that I placed a copy of the inquiry’s terms of reference in the Libraries of both Houses on 24 August 2021.

This follows a consultation by the inquiry on its terms of reference which commenced on 26 May and concluded on 3 August 2021. The inquiry team reached out to and heard from affected families, patients, local community groups, charities, and other individuals and organisations with an interest in the issues laid out in my earlier statement.

The terms of reference have also been published on the inquiry’s website https://www.emhii.org.uk/.

[HCWS255]

Written Parliamentary Questions 155392 and 170718: Correction

Nadine Dorries Excerpts

Monday 6th September 2021 Written Statements

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

I would like to inform the House that I wish to correct the formal record in relation to written answers to the hon. Member for Streatham (Bell Ribeiro-Addy) on 2 March 2021 and the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) on 25 March 2021.

The reply suggested that NHS England and Improvement was developing a case definition and model of care for children with the National Institute for Health and Care Excellence (NICE) and the Royal College of Paediatrics and Child Health (RCPCH).

The correct response was that NHSEI had run an initial workshop on long covid to discuss how best to develop a case definition and model of care for children at which the RCPCH was present.

The response was phased in a way that overstated the role of the RCPCH in producing clinical guidance. NICE is responsible for developing the clinical case definition of Long covid.

I would like to thank the RCPCH and its members for their contributions more broadly in improving the understanding of long covid in children.

[HCWS258]

Independent Medicines and Medical Devices Safety Review Report: Government Response

Nadine Dorries Excerpts

Wednesday 21st July 2021 Written Statements

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

The report of the Independent Medicines and Medical Devices Safety Review (IMMDS review) was published on 8 July 2020.

On 11 January, I updated the House on the Government’s progress in responding to the recommendations of the IMMDS review.

I am pleased to today announce to the House the publication of the Government’s full response to the IMMDS review. We have accepted four of the nine strategic recommendations in full, one in principle and two in part. We have also accepted 46 of the 50 actions for improvement in full or in principle, one in part and one remains under consideration. We do not accept two of the actions for improvement.

This response sets out an ambitious programme of change, which at its core is about improving patient safety by:

improving how the system listens to and responds to concerns raised by patients by putting patient voice at the centre of patient safety:

strengthening the evidence base on which decisions are made, including through making sure the right data is collected and used; and

improving the safety of medicines and devices, and embracing the new opportunities following the UK’s departure from the European Union to reform regulatory frameworks.

Recommendation 1: the Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.

The Government accept recommendation 1.

In July 2020, the Government apologised in full on behalf of the healthcare system to all the families affected by the report for the time it has taken to listen and respond to their concerns. I salute their courage and persistence in coming forward to make these concerns heard; without their bravery, the review would not have been possible.

Listening to patients

The review was commissioned because the Government recognised and accepted that the system had taken too long to listen to patients. One of the key conclusions from the report was that “the system has not been listening as it should”. The Government recognised the need for effective patient engagement to rebuild trust and ensure that patient voice was embedded in work to develop the full Government response to the report. We were pleased to announce in January that we had accepted the second part of the report’s ninth recommendation, for the establishment of a patient reference group (“the group”).

The purpose of the group was to provide challenge, advice and scrutiny to the work to develop the Government’s response to the report’s recommendations. The group represented a diverse range of experiences, and members include individuals who have been affected by or have an interest in pelvic mesh, sodium valproate, and hormone pregnancy tests (HPTs), those who have been affected by or have an interest in other medicines or medical devices, and also those with a wider interest in patient safety. The group met regularly and worked closely with officials to discuss the report’s recommendations in great detail. I met with the group in June to listen to their feedback directly.

We are extremely grateful to the group for their insight and honesty. The Government response has undoubtedly been strengthened through listening to and learning from group members’ experiences, knowledge and expertise. I am very pleased that the final report of the patient reference group has been published alongside the Government response today.

Recommendation 2: the appointment of a patient safety commissioner who would be an independent public leader with a statutory responsibility. The commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.

The Government accept recommendation 2.

Patient safety is a top priority for the healthcare system; we want to make the NHS the safest healthcare system in the world, and we must retain an absolute focus on achieving this goal.

As Members will know, the central recommendation in the report is for the establishment of an independent patient safety commissioner.

The Government have accepted this recommendation, and we have already legislated for a patient safety commissioner through the Medicines and Medical Devices Act 2021 (MMD Act).

It is integral that patients are listened to in our healthcare system and the commissioner will help to make sure patient voices are heard, as envisaged in the report of the IMMDS review.

The core role of the commissioner will be to promote the safety of patients in the context of the use of medicines and medical devices and to promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.

A public consultation is currently open seeking views on the proposed legislative details on the appointment and operation of the commissioner. The consultation closes on 5 August 2021. After the consultation has closed, responses will be carefully considered and reviewed, and will feed into the drafting of the regulations on the appointment and operation of the commissioner.

We plan to have the first patient safety commissioner in post in the first half of 2022.

Recommendation 3: a new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.

The Government do not accept recommendation 3.

As set out in the January statement, we have no current plans for a redress agency, as set out in recommendation 3.

We do not believe it is necessary to create a new agency for redress as it is already possible for the Government and others to provide redress for specific issues where that is considered necessary. Neither do we believe that creating an agency would succeed in making products safer as the report suggests, or that grouping existing redress schemes through a single front door would add value for harmed patients.

Recommendation 4: separate schemes should be set up for each intervention—hormone pregnancy tests (HPTs), valproate and pelvic mesh—to meet the cost of providing additional care support to those who have experienced avoidable harm and are eligible to claim.

The Government do not accept recommendation 4.

While the Government are sympathetic to the experiences of those patients who gave evidence to the report, our priority is to improve the future safety of medicines and medical devices. This includes not just the products themselves but also ensuring they are used in line with the latest evidence of best practice—in ways that are both effective and safe for patients. This means we will continue to focus our work on direct support for future safety, improve how the system listens to patients, and support and monitor the safety of clinical practice where medicines and devices are concerned. The MMD Act delivers further on our commitments to patient safety, embedding reform through legislation and delivering an ambitious programme of improvements medicines and medical devices.

Recommendation 5: networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.

The Government accept recommendation 5 in part.

The Government accept the first part of recommendation 5; specialist centres for those adversely affected by implanted mesh.

Much progress has been made to establish the specialist mesh services, led by NHS England and Improvement. These services became operational on 1 April 2021, and there are now eight specialist centres in operation across England. Good progress is being made towards the establishment of a ninth regional service with a south-west provider, to ensure patients across the country can access these vital services. It is important that women have choice over their surgeon where possible and I am happy to confirm that when patients request treatment for mesh complications, they can exercise patient choice and be referred to another centre if they wish.

The report of the IMMDS review highlights the importance of the specialist services working together and re-enforces the need for the commissioned mesh services to network across providers to ensure each service provides comprehensive treatment, care and advice services. I am pleased to confirm that the providers of specialised services for women with complications of mesh will meet annually from 2021 at a clinical summit to discuss data and outcomes.

Recognising the need for enhanced data collection on pelvic mesh, the Government in 2018 announced the provision of £1.1 million for the development of a comprehensive database of urogynaecological procedures, including vaginal mesh, to treat pelvic organ prolapse and stress urinary incontinence. I can update the House that the pelvic floor information system has started to receive live data, including historical data from July 2017 onwards, with an initial focus on supporting specialist services to report every pelvic floor and comparative procedure to this national database.

The report of the IMMDS review also recommends that the information system is accompanied by a retro-spective audit of mesh procedures, and by the development of a patient reported outcome measure (PROM) or patient reported experience measure (PREM). I am pleased to announce to the House today that the Government accept both these recommendations. NHS Digital has been commissioned to scope and deliver the retrospective audit. Subject to receiving high quality research bids, a new validated PROM for pelvic mesh procedures will be commissioned through the National Institute of Health Research in 2022. Additionally, earlier this year a £440,000 research study into “Experiences of Urogynaecological Services” was commissioned by the NIHR to feed into this vital work to develop a new PROM.

The Government do not accept the second part of recommendation 5, specialist centres for those adversely affected by medications taken during pregnancy.

We recognise the underlying issue that there is a need to improve the care and support for the individuals and families affected by a range of medicines used in pregnancy, including valproate exposure. However, our view is that a network of new specialist centres is not the most effective way forward. We will instead take forward work to improve the care pathways for children and families affected by medicines in pregnancy, within existing services. This will include strengthening care pathways and tackling the variation in access to services across NHS regions.

Currently, services for all children with neuro-developmental disorders are primarily managed by multidisciplinary teams within child development centres, which are commissioned locally. These are then supported by regional clinical networks, and specialised neuroscience centres. A limited number of specialist centres focused only on those affected by medications in pregnancy would not be able to provide the whole range of services that patients need, for example coordinating provision across local health, education and social care systems. It is important that patients who need ongoing care can access services as conveniently as possible, and many of these services are better delivered at a local level. Additionally, a new network of specialist centres could divert clinical expertise and potentially result in a reduced service for all the patient groups involved.

We will also continue work to improve the safety of medicines in pregnancy more widely, and to ensure that valproate is only prescribed where clinically appropriate.

Sodium Valproate

The report of the IMMDS review discusses sodium valproate (valproate) in much detail and contains a number of actions for improvement related to valproate. For this reason, we have dedicated a chapter in the Government response to valproate.

The January statement updated on the significant work underway to ensure valproate is only used where clinically appropriate, and to improve patient safety for women and girls for whom there is no alternative medicine. The Government do not however support calls to eliminate the use of valproate completely; for some women, it is the only drug which is able to control their epilepsy, and it is vital that women are able to access effective treatments.

I am pleased to update the House that much progress continues to be made. The first report from the valproate registry was published on 11 February 2021, and a second is planned for September 2021. The first report presents an important step to improving our ability to monitor implementation and compliance with the pregnancy prevention programme. There are plans to extend the registry to the whole of the UK and to expand it to include other anti-epileptic drugs later this year, as recommended by the report. As recommended by the report, NHS England and Improvement have recently sent a letter to all women of childbearing age who are prescribed valproate, including important safety reminders in relation to contraception, pregnancy and regular prescribing reviews.

I have also heard from patients that measures to reduce valproate prescribing and support women to make informed choices must be holistic and wide-ranging. I am pleased to announce that the MHRA is planning to consult on an amendment to the human medicines regulations which would require pharmacists to supply sodium valproate in the manufacturers original pack with a patient informational leaflet. This will ensure that prescriptions for valproate are dispensed with a patient information leaflet and information on risk minimisation measures.

Recommendation 6: the Medicines and Healthcare Products Regulatory Agency (MHRA) needs substantial revision particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.

The Government accept recommendation 6.

In the January statement the Government announced that the MHRA initiated a substantial programme of work to improve how it listens and responds to patients and the public, to develop a more responsive system for reporting adverse incidents, and to strengthen the evidence to support timely and robust decisions that protect patient safety.

This is set out in detail in the MHRA’s corporate delivery plan for 2021 to 2023, “Putting patients first—a new era for our Agency”, which was published on 4 July. This sets out the MHRA’s future plans, which centre on: putting patients first; becoming a truly world-leading, enabling regulator; and protecting public health through excellence in regulation and science.

A key strand of this work is improving how the MHRA engages with patients, and ensures patients have an integral role in its work. In May this year, the MHRA published its draft “Patient and Public Involvement Strategy” for public consultation. This sets out how the Agency will deliver a step change in its involvement and engagement with patients. Following the consultation, the MHRA will publish the final strategy later this year.

I am pleased to confirm to the House that the MHRA’s newly appointed chief safety officer will lead the MHRA’s ongoing implementation of the recommendations from the report. This will help to ensure that the MHRA continues delivering on their commitment to keep patients safe. The postholder will oversee the development of a revitalised approach to vigilance of both medicines and medical devices.

Recommendation 7: a central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.

The Government accept recommendation 7.

The Government have legislated for a patient identifiable database in the MMD Act, which creates a power for the Secretary of State to regulate for the establishment of a UK-wide medical device information system (MDIS).

The report of the IMMDS review rightly identifies the need for the healthcare system to centralise and standardise the collection, retention and analysis of data for monitoring the safety and effectiveness of implantable medical devices. In order to close the gap identified in the collection and analysis of this data, it is essential that the UK has a comprehensive system to ensure that implantable devices are effectively monitored and any issues affecting patient safety are responded to appropriately. As required by the MMD Act, the Government are planning to hold public consultation on the MDIS regulations. Formal public consultation on the MDIS regulations will begin later this year with the aim of laying the regulations in 2022.

Alongside developing regulations, I can announce that over £11 million has been set aside for a package of work in 2021-22, involving partners across the healthcare system to scope, test and cost options for MDIS and other medical devices patient safety workstreams.

Recommendation 8: transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests and their recognised and accredited specialisms, in addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.

The Government accept recommendation 8 in principle.

The Government accept in principle the first part of recommendation 8, for greater transparency of doctors’ interests.

We agree that lists of doctors’ interests should be publicly available, but we do not think that the GMC register is the best place to hold this information. It is absolutely crucial that any published list of interests is meaningful and accessible to patients. Our approach is therefore for publications of interests to be held by healthcare providers at the local level, because patients know where healthcare professionals work, and are more likely to seek information from the organisation that provides their treatment and care. Additionally, at the local level healthcare providers can ensure patients have the necessary support to understand the relevant information

We also believe that it is not just doctors who must declare their interests, but rather all registered healthcare professionals. That is why we are going further than the recommendation, and we will make it a regulatory requirement that all registered healthcare professionals must declare their relevant interests. Registered healthcare professionals will be required to declare their relevant interests to their employer, contractor, or the organisation where they are providing services. All healthcare providers will be required to collect, monitor, and publish a list of their employees’ relevant interests. At the local level, healthcare providers must ensure that all declarations of interest are publicly available for patients to access, and providers can then ensure there is meaningful oversight of publications of interests.

These changes build on current NHS guidance, which states that all staff should declare interests and organisations should publish the interests of decision making on their website. These changes will also extend publication of declarations of interest to the private sector. We will continue to work with healthcare organisations across the NHS and independent sector, as well as regulators, to ensure there is appropriate implementation, governance, and enforcement of this approach.

The Government also accept in principle the second part of recommendation 8, for mandatory reporting of payments from the pharmaceutical and medical device industry.

The Government agree that transparency of medicine and medical device industry payments to clinicians and organisations is an important part of ensuring patient confidence. As with doctors’ interests, it is important that this information is published and easily accessible for patients.

Regarding medicines, the Government have listened to stakeholder concerns that the existing industry scheme is voluntary, and that more could be done to achieve consistent transparency in reporting of payments. We have listened to concerns from patient groups and others that a mandatory scheme is needed. We are exploring options to expand and reinforce current industry schemes, including making reporting mandatory through legislation.

Regarding medical devices, we recognise that the sector does not have any formal scheme for reporting payments. We have listened to stakeholder concerns that the current situation means that that patients lack crucial information on a highly important area of clinical decision-making. We will work with the devices industry and other stakeholders on the options for introducing reporting of payments for the medical device sector, including making reporting mandatory through legislation.

Recommendation 9: the Government should immediately set up a taskforce to implement this review’s recommendations. Its first task should be to set out a timeline for their implementation.

The Government accept recommendation 9 in part.

As set out in the statement of 11 January, the Government have no plans to establish an independent taskforce to implement the report’s recommendations. As is convention with independent reports and inquiries, conclusions and recommendations are passed to Government for consideration.

The Government have considered the report’s recommendations carefully, and our response sets out an ambitious programme of change. We have accepted the majority of the report’s nine strategic recommendations and 50 actions for improvement.

The actions set out in this response are a combination of well-established programmes of work and new initiatives. The Government are committed to making rapid progress on all the areas set out in this response. To ensure that Parliament and patients can continue to hold the Government to account, we will publish an update on progress to implement the Government response in 12 months’ time.

Conclusion

The report of the IMMDS review is a powerful call to action, and we are determined to deliver meaningful change through the Government response.

I would like to once again thank my right hon. Friend the Member for South West Surrey (Jeremy Hunt) and my right hon. Friend the Member for Maidenhead (Mrs May) for commissioning this landmark review, and to thank Baroness Cumberlege and the review team for their diligence and dedication in conducting this review.

Above all, I would like to once again recognise and thank the women and their families, who fought to bring these issues to light and to have their stories heard.

The report highlights a stark inequality in the healthcare system. We cannot ignore the fact that the report of the IMMDS review is one of several independent reports and inquiries to have concluded that our healthcare system disproportionately fails to listen to women and keep them safe. This Government are determined to change this, not least through our work to develop the first ever women’s health strategy for England later this year.

I am depositing a copy of the Government response and the “Independent Report of the Patient Reference Group” in the Libraries of both Houses.

[HCWS225]

Do Not Attempt Resuscitation Orders: Guidelines

Nadine Dorries Excerpts

Wednesday 21st July 2021 Westminster Hall

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

It is a pleasure to serve under your chairmanship, Ms Bardell. I thank my hon. Friend the Member for Cleethorpes (Martin Vickers) for bringing this extremely important topic to our attention.

I am well aware that the issue is highly emotive. Conversations around end of life and DNACPRs are some of the most challenging conversations that a clinician can have. It is important that they are approached in a compassionate and meaningful way that takes fully into account the wishes of the patient. I have had such conversations myself, both in the distant past in my professional capacity as a nurse, and recently in a more personal capacity, so I share and understand the concerns raised by my hon. Friend. I understand how difficult those conversations are, particularly if the person with whom a clinician is attempting to have the conversation does not want to have it.

I reassure my hon. Friend that the Department remains crystal clear that standards and quality of care should be maintained even in pressurised circumstances. Failure to consult people and their families on individual decisions on CPR causes significant distress. It is essential that such conversations are held in a sensitive and compassionate way, and that that is consistent across the health and care system.

There is already commendable joint guidance for clinicians on DNACPRs from the British Medical Association, the Resuscitation Council UK and the Royal College of Nursing. That guidance reflects that the agreement to a DNACPR is an individual decision and should involve the person concerned or, where the person lacks capacity, their families, carers, guardians and other legally recognised advocates.

In addition, significant work has been done over the last 16 months by the Department and clinical leaders to support practitioners in understanding best practice guidance. Clear messages around the use of DNACPR decisions were reinforced in our adult social care winter plan in September 2020, making clear that any advanced care decisions, including DNACPR decisions, should be fully discussed with the individual and their family where possible and appropriate, and signed by the clinician responsible for the individual’s care. Those guidelines were reinforced as recently as September 2020.

It has been well reported, however, that the pandemic shone a necessary but critical light on the application of DNACPR decisions, and highlighted how, in some cases, conversations were not always held in a patient-centred way. We heard particularly worrying reports about the inappropriate or blanket application across groups of people, including our most vulnerable.

To ensure that we could take early learnings on what was happening across the system, in October 2020 I commissioned the Care Quality Commission to review how DNACPR decisions were being made in the early stages of the pandemic. Its report, which was published on 18 March, highlighted examples of what good conversations around DNACPR look like. However, it also drew a worrying picture of the reasons why some of these conversations fell short of the high-quality personalised care people deserve. Of the three key areas for improvement the report identified, the application and adherence to guidance across the system was an area of concern. The report found a greater need for information, training and support for health and care professionals, to enable them to hold good, meaningful conversations. It is integral, therefore, that the training practitioners receive reflects that, to ensure that people’s needs and rights are met. It is critical that all staff have the knowledge, skills and confidence to speak with people about, and support them in making, appropriate DNACPR decisions, as well as feeling empowered to speak up when they do not feel the decision is right.

That is why I established a ministerial oversight group. The first meeting was held on 8 June and it brought together key organisations responsible for driving forward system-wide improvements, and provided an opportunity to set up their commitments. I found it encouraging to see a shared commitment to improve the use of DNACPR orders. I heard first hand of the ongoing work to improve knowledge and understanding of these issues, and the work being done to support colleagues across health and social care, to maintain and champion personalised approaches to care treatment. I believe that the terms of reference for the ministerial oversight group have gone live today on the gov.uk website, so that my hon. Friend the Member for Cleethorpes can see the issues that we have decided we need to address in order to improve the use and application of orders.

Although I mentioned that a considerable amount of excellent guidance and support around DNACPRs already exists, with meaningful conversations taking place every day, it is clear that improvements are needed on consistency, training and implementation. It is a difficult conversation for clinicians to have. A priority of the ministerial oversight group will be to ensure that there is better awareness, understanding and use of the guidance and resources available across the system, so that everybody can practise these conversations to the same degree of effectiveness and the same standards.

We are also working closely with our stakeholders across health and care to ensure that that happens. Clearly, this is a work in progress and training should remain under constant review, both in the wider workforce and to ensure that staff understand the training that they receive. We must also ensure that people feel equal partners in their care, and are well equipped for conversations around the end of life.

NHS England has published public-facing guidance on DNACPR decisions, along with the release today of the terms of reference of my ministerial oversight group. NHS England has also published where people can get support if they are concerned about a DNACPR decision, on england.nhs.uk. If anyone is concerned, they can find the guidance and know what they can do and say to challenge decisions.

Sensitive and well communicated DNACPRs can and should be an important part of patient care and end-of-life experience. We are committed to taking continued action—that is the point of the ministerial oversight group—to ensure guidance on DNACPR decisions is adhered to, that the training is in place, that the guidance is adhered to and that clinicians have the appropriate support to hold those difficult conversations.

Question put and agreed to.

Covid-19 Tests: Mandatory Validation Regime

Nadine Dorries Excerpts

Tuesday 20th July 2021 Written Statements

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

This statement sets out the analysis used to support the development of the mandatory validation regime for covid-19 tests before they can enter the UK market. This goes alongside the full impact assessment, which we have published.

Testing will continue to form a crucial part in the response to covid-19. Consumers must have confidence in the performance of tests they use. That is why the Government are bringing in draft legislation under the Medicines and Medical Devices Act 2021, which will require all antigen and molecular covid-19 tests to undergo mandatory validation to assess their performance before being permitted for sale on the UK market. This will ensure that any covid-19 test on the UK market meets a minimum standard, the same standards as those met by covid-19 tests procured for the NHS.

We have engaged with the Regulatory Policy Committee (RPC) throughout our work to ensure that our analysis meets the high standards the committee upholds. We thank them wholeheartedly for their constructive feedback and for working at pace to meet an unusually tight legislative timetable.

While the Department is working to produce a revised impact assessment, we intend to publish the current draft in the interim for transparency. In developing this assessment, we brought together regulatory knowledge in an area where we have not innovated policy for decades, alongside the ongoing challenges of modelling both economic and epidemiological predictions. We were unfortunately red rated in one key area which has resulted in a red rated IA. While I am obviously disappointed in this rating, we remain committed to working closely with the RPC to ensure that we produce a final IA that we are all satisfied with and proud of, making use of the latest data from a nascent and rapidly evolving market.

The analysis to date strongly supports our planned policy intervention. This is a necessary regulation to protect consumers and give reassurances to producers. While we do recognise the potential profit loss for companies whose products do not meet the required standards, this is a necessary move to ensure the highest-quality tests are available to protect consumers and public health. We have looked carefully at this and are committed to work closely with these producers to ensure they understand the requirements and can work to achieve them. Furthermore, the potential profit loss needs to be set against the additional profits that manufacturers who are producing high-quality tests that meet the validation standards could potentially gain, and the benefit to society of removing poorly performing tests and associated public health impacts.

The RPC has identified areas for further development, which include:

The need to enhance our analysis of the latest evidence of the share of the market for covid-19 tests which are accounted for by businesses based in the UK. This determines whether business impacts are reflected in the equivalent annual net direct cost to business (for businesses based in the UK) or as trade impacts (for businesses based elsewhere).

The need to test with stakeholders (or otherwise confirm) our assumptions about the proportion of devices presenting for validation (currently assumed to be 60%)—this affects profit/EANDCB/trade impacts since products not validated will be removed from the market) and the life cycle of devices (currently assumed to be 1-5 years—this affects programme costs in determining how frequently manufacturers need to submit devices for validation)

The need to explain further how we have:

 extrapolated from third party estimates of the future size of the private testing market size;

 established and treated stakeholders’ estimates of market profit margins; and

 estimated familiarisation and transition costs, including the use of any non-wage uplifts.

The need to add new content (and test with stakeholders - or otherwise confirm) to address:

 familiarisation costs incurred by retailers; and

 how devices online will be monitored and enforced.

The RPC fulfils a crucial role in ensuring that analysis and evidence in regulations are robust and assessed to an extremely high standard. The Government are committed to this process and in relation to this policy, we are determined to ensure the impact assessment we complete includes the best possible research and evidence available.

The impact assessment is a living document, used to support the process of policy design and implementation. We plan to make further iterations of this impact assessment publicly available ahead of the next statutory instrument we intend to lay in the autumn, which will introduce a second element of laboratory validation.

[HCWS208]

Reducing Baby Loss

Nadine Dorries Excerpts

Tuesday 20th July 2021 Westminster Hall

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

It is a great pleasure to serve under your chairmanship, Mr Gray, and a huge pleasure to respond to my hon. Friend the Member for Truro and Falmouth (Cherilyn Mackrory). Many tributes have been paid to her bravery, courage and compassion and to how inspirational she is on this issue. I echo all that and thank her for securing this debate today on an incredibly important issue.

This debate has an hour and a half. If we had half a day, it still would not be enough. I have 10 minutes and a huge amount of information to respond to. I will not be able to respond to all the questions and issues raised in those few minutes. The hon. Member for Nottingham South (Lilian Greenwood) and I have a call very soon and we will discuss Nottingham in detail during it.

I want to start by saying that the UK is one of the safest countries in the world to give birth. We are safer than Canada, the United States, France and New Zealand. I could go on listing how safe we are. We have made good progress. I want to start with that context. We have made really good progress in improving maternity safety over the past few years. The original ambition was to halve the 2010 rates of stillbirths, neonatal and maternal deaths, and brain injuries in babies occurring during or soon after birth by 2030. We updated that ambition in 2017 to bring forward that date to 2025 and to include an additional ambition to reduce the rate of pre-term births from 8% to 6%.

In relation to stillbirths, we are making solid progress towards meeting that ambition. Since 2010, the stillbirth rate has fallen from 5.1 stillbirths per 1,000 births to 3.7, which equates to a 25% reduction in the stillbirth rate. That places us firmly ahead of our target to meet the 2020 ambition for a 20% decrease, and that means there are now at least 750 fewer stillbirths each year.

Similar progress has been made on reducing the number of neonatal deaths. According to the ONS, there has been a 29% reduction in the neonatal mortality rate for babies born over 24 weeks of gestational age of viability. I am particularly proud of that progress and acknowledge that progress on reducing the maternal mortality rate, the brain injury rate and the pre-term birth rate has been slower. However, according to a bespoke definition developed by clinicians at the request of the Department of Health and Social Care, the overall rate of brain injuries occurring during or soon after birth has fallen to 4.2% per 1,000 births in 2019 from 4.7% per 1,000 in 2014. Although that progress is slower, we are still seeing a reduction.

Because of that slower reduction, on 4 July I announced £2 million of funding to support a new programme to reduce brain injuries in babies. The first phase of the programme is being led by the Royal College of Obstetricians and Gynaecologists, the RCM and the Healthcare Improvement Studies Institute at the University of Cambridge. It aims to develop clinical consensus on the best practices for monitoring and responding to babies’ wellbeing during labour—the progress of the baby during labour has been mentioned a number of times—and in managing complications with the baby’s positioning, specifically when a baby’s head is impacted in the mother’s pelvis during a caesarean section.

Funding for the second phase of the work, beginning later this year, will begin to implement and evaluate this new approach to inform how we can roll it out nationally. On pre-term births, recent ONS provisional data shows the percentage of all pre-term live births decreased for the second year in a row, from 7.8% to 7.5%.

Although we have had a reduction in maternal deaths, there is still more work needed to address the underlying causes of why mothers die in or shortly after childbirth. In the 2016 to 2018 data, 217 women died during or up to six weeks after pregnancy. That represents a 9% reduction in the maternal mortality rate against the 2009 to 2011 baseline, but we obviously need more up-to-date data on that. Some 58% of the deaths were due to indirect causes, such as cardiac disease and neurological conditions. This means that we need to look not only at what maternity services can do during the 40 weeks or less they may care for a woman while she is pregnant, but also at a lifetime approach—supporting women to be in the best health before pregnancy.

To care for pregnant women with acute and chronic medical conditions, NHS England is rolling out maternal medicine networks to ensure that there is timely access at all stages of pregnancy. In the debate today, a number of people have mentioned staffing levels and workforce. We have recently announced £95 million towards increasing the workforce in maternity units—some 1,200 additional midwives and 100 additional consultant obstetricians. The figures have been calculated at trust level on the basis of birth rate, along with the RCOG. We have also given the RCOG £500,000 to develop a workforce tool for planning, so that we have as safe staffing levels as we can have on maternity units, when they are needed.

I am going to go on to the nitty-gritty of the problems that affect some of the outcomes that we are trying to negate during pregnancy. We know that obesity during pregnancy puts women at an increased risk of experiencing miscarriage, difficult deliveries, pre-term births and caesarean sections. I underline the importance of helping people to achieve and maintain a healthy weight in order to improve our nation’s health.

That is why we launched the obesity strategy in July 2020. The strategy sets out a campaign to reduce obesity, including measures to get the nation fit and healthy. We know that obesity has a huge impact on covid-19. According to the RCOG, the overall likelihood of a stillbirth in the UK is less than one in 200 births, but if a woman’s body mass index is over 30, the risk doubles to one in 100. According to Public Health England, 22.1% of women were obese in early pregnancy. If a woman’s BMI is higher than 25, that is associated with a range of additional risks, which I will not list now, but which include miscarriage.

On smoking, some 12.8% of women in the UK were smoking at the start of pregnancy and 10.4% of women were smoking at the time of delivery. With the new emphasis on public health post covid, I requested meetings with Public Health England to discuss how we once again emphasise the negative effects of smoking during pregnancy and the impact of obesity, particularly given the RCOG figures of the doubling of the risk of stillbirth for women with a BMI over 30.

[Sarah Owen]

I am sure it is not the Minister’s intention that the tone of the response, particularly in this section, feeds into the guilt that many women experience having suffered miscarriage or stillbirth. It feels as if the onus is being put on the woman—that the reason they have experienced this loss is entirely their fault. Perhaps, if we want to tackle the root causes of obesity and smoking and those reasons for baby loss, we would be tackling the root causes of deprivation, not necessarily focusing on personal responsibility in the way that the Minister has just outlined.

[Ms Dorries]

I could not agree more, but we are doing nobody any favours whatsoever if we do not inform women of the impact of smoking and obesity during pregnancy. Before covid—some time ago—Public Health England had a huge emphasis on the negative effects of smoking during pregnancy, and we think we need to focus once more on the fact that 12.8% of women are smoking at the beginning of pregnancy and 10.4% are smoking at the time of delivery, as part of this approach to continuing to reduce the number of stillbirths. To keep that trajectory moving, we have to discuss all the reasons why and all the health implications during pregnancy.

A number of Members mentioned the continuity of care programme. We are committed to reducing inequalities in health outcomes and experience of care. In September 2020, I established the maternity inequalities oversight forum to bring together experts from key stakeholders to consider and address the inequality for women and babies from different ethnic backgrounds and socioeconomic groups.

In response to a direct question from my hon. Friend the Member for Truro and Falmouth, we wanted to see all women placed on the continuity of care pathway by March 2022, but that will not be possible. We are therefore focusing on having 75% of black, black British, Asian and Asian British women on the continuity of care pathway by 2024. We will have 20% of all women on that pathway at the same time. The issue of training on continuity of care was brought up, and that is the important point. We can talk about continuity of care pathways, but it is about having the right training in place and ensuring that those midwives who have those women on that pathway and are caring for them are trained in the particular inequalities that my hon. Friend mentioned. That is why it will take us to 2024, but we will have 75% of those ethnic minority women on that pathway by that date.

A number of Members mentioned covid-19. It has caused a huge amount of disruption to our lives. As the hon. Member for Luton North (Sarah Owen) said, women have continued to have babies throughout that time. Maternity and neonatal services have worked hard to enable partners to be present during labour and birth. According to the latest information, all maternity partners are accompanying women to all antenatal scans and appointments in acute settings.

The hon. Member for Luton North also brought up vaccinations. She made the point that the Government need to ensure that all pregnant women are vaccinated. My daughter is 32 weeks pregnant, so no one has been more aware of that than me, but I am afraid that politicians do not make clinical decisions, and the Government are not the JCVI—the Joint Committee on Vaccination and Immunisation is completely independent. The committee decides who is vaccinated.

After constantly asking why pregnant women were not being prioritised and taking a glance at the make-up of the JCVI, however, I was shocked to discover that it is made up of 14 men and three women, so I am unsurprised at the JCVI not emphasising or prioritising pregnant women for vaccination. Again, that is a point I am making in the Department and in particular with the women’s health strategy. Perhaps all scientific committees that make decisions about women’s health should have a gender balance.

I want to reassure the hon. Member for Luton North that I am absolutely on to that and have been all the way through. I might just be beginning to get a bit of insight into why the JCVI has not prioritised pregnant women for vaccination. It is shameful that they were not; they should have been. She highlighted the data herself at the L&D hospital, which is one of my local hospitals, and I hope that the hospital will now begin—despite the constant requests and pressure from Government—to review its policies on pregnant women and vaccination.

I thank the Health and Social Care Committee and its independent expert panel for its inquiry into the safety of maternity services and evaluation of maternity commitments. The Department is considering the recommendations made in the report and will publish a full response in September.

In conclusion, I am absolutely proud of the progress that we are making on stillbirths, neonatal deaths and maternal deaths, but we have to do more. That will involve Public Health England, and that will involve looking at all the reasons why and all the targets that we have to beat so that we can reach those ambitions and reduce those figures.

Draft Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021

Nadine Dorries Excerpts

Wednesday 14th July 2021 General Committees

[The Chair]

I thank Members for observing social distancing, and remind them that Mr Speaker has stated that face coverings should be worn in Committee unless Members are speaking or they are exempt. Hansard colleagues will be most grateful if Members could send their speaking notes to [e-mail]. The eagle-eyed among you will have noticed that, because of the inclement—to a Yorkshireman—hot weather, if people wish to remove their jackets they are welcome to do so.

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

I beg to move,

That the Committee has considered the draft Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021.

It is a great pleasure to serve under your chairmanship, Mr Davies. Please excuse my opening line—this will be my second pun before 9.30 in the morning—but we live in testing times, literally and metaphorically. The covid-19 pandemic has been a test—for our NHS, for us as a nation, and for everyone. In order to fight the virus, we have had to endure restrictions, but the resolute determination that people have shown during lockdown demonstrates the best of the British character. The amazing performance of our NHS has shown why the UK is stronger united against any storm that may hit these isles. Though many trials have broken upon us, this has not broken us.

As we continue to open up society—spending time with friends and family once again, and enjoying pubs, clubs, football matches and horse-racing—we cannot become complacent about the virus; we must remain vigilant. We are reliant on everyone to protect each other from the virus, and to take responsibility for their health. One in three people with coronavirus show no symptoms and are potentially spreading it without knowing, so testing will remain vital to controlling and containing the spread.

Employers and others are keen to buy their own tests for their staff, to pitch in and do their bit and take pressure off the NHS. I want to empower them to do that, but that requires them to be able to use tests that are at least as good as those in the NHS. However, of 280 tests assessed by the Department of Health and Social Care for public procurement, only 50 were found to reliably detect the virus.

No one wants one bad test kit to reset a year of hard work by giving false negatives that cause people to unknowingly spread the virus once more. That is why we need a strong, independent validation system, with robust enforcement, to enable delivery of reliable, affordable and high-quality tests. First and foremost, any regulations should help protect public health. Strong yet agile regulation for covid-19 tests is essential to that end. As individuals and businesses take on more of a role in our testing effort, it will become a partnership between people, Government and the private sector, with independent validation underpinning trust and confidence in the testing market and remedying the current market failure, to the benefit of both consumers and producers.

It is vital that consumers have clear, comparable information that lets them cut through the confusion and buy with confidence. I want people to know that if they choose to buy tests, the ones available will be as good as those that they would receive on the NHS, so that they can trust the results that they get. That will empower people to take charge and make their own decisions about managing their personal health. This is a chance for producers to show what their tests can do through a fair and equitable system.

Some producers of tests have invested in these technologies in good faith, and feel that they have effective tests that they have successfully trialled with their own processes, but cannot seem to get them validated. Understandably, they question the Porton Down protocols and feel disappointed that they cannot join the procurement frameworks. I hear those concerns and share the frustration, but my message is that our validation processes are the most thorough in the world. Companies often question standards that they cannot meet, but we stand by those standards and will not buy tests that do not meet them. We work with firms to try to get them to the right standard. Patients and taxpayers would not thank us if we bought tests that did not perform to those standards. Self-certification by diagnostic firms is not an approach that has proved reliable during the pandemic.

This statutory instrument, which the Government have laid before Parliament, will establish a clear regulatory regime through which the Government will ensure that all tests on the UK market meet the performance standards set for the NHS. We have experience of validating tests for Government procurement; the regulations build on that expertise to create an agile regime that will validate all polymerase chain reaction and lateral flow tests that meet those standards. We are confident that this will enable the ongoing supply of high-quality tests to the UK market.

The regulations set clear performance thresholds, which provide rigorous yet fair criteria that industry will have to meet by undergoing an expert review. Manufacturers should see that as an opportunity to have their products tested, and to get feedback. It is an opportunity to have high-quality scientific advisers assess the product, and then to allow businesses to make it a race to the bottom, minimising costs while they take advantage of the pandemic to maximise their profits. We will publish a register of tests that pass validation, along with other information that is clear and comparable. Empowered by that information, consumers and companies can make informed and prudent choices when buying kits for themselves, their families or their workforce.

We intend the regime to recover its costs primarily from manufacturers, rather than being supported by taxpayers. However, I am conscious of the concerns raised during the consultation that fees set too high could be a barrier to small and medium-sized manufacturers entering the market. We firmly recognise the important, innovative contribution our small and medium-sized enterprises make. We have implemented a discount for such businesses, so that their dynamism, creativity and nimbleness continue to bring new tests to market to meet the changing needs of people and businesses.

Industry will require time to adapt to our new regulatory requirements. We have balanced the need to give industry reasonable time against the need to remedy the market failure. To strike this balance, I have instituted phased grace periods for those manufacturers who work with us. This will mean any tests already on the market will be able to remain there if the manufacturers do what is required of them. I have clearly set out that they have until 1 September 2021 to register their tests for the validation process.

They will then have until 31 October to complete and pass the process.

The diagnostic device manufacturers in the UK include a few big players, but 90% are small and medium-sized enterprises. We have implemented a discounted fee for them, so that they continue to bring new tests to market, and meet the changing needs of people and businesses. I am confident that any well-run company with a quality product can meet the lower fee of £6,400.

No one wants a regulatory wasteland, full of failed businesses, where we are entangled by distrust, disreputable weeds grow, and consumers have to beware with every step. Good regulation helps to ensure a well maintained garden where businesses thrive and blossom into success, where there is trust between buyers and sellers, and where consumers are safe to explore.

I do not see passing these regulations as the end; it is merely the beginning. I will add to the regulations later this year with a further laboratory stage, underpinned by a second statutory instrument. That will also provide an opportunity to consider emerging issues. Beyond that, my officials will continually engage with stakeholders to ensure that the process is as smooth as possible, and will conduct a review next year, which I will lay before the House. The review will provide recommendations on how to refine the regulations, and on what lessons we can learn to help bolster the diagnostic legacy of this pandemic.

The BMJ highlighted the importance of early diagnostics, and set out why we need a sea change to our approach to disease management once the pandemic passes:

“Poor diagnostic preparedness has contributed to significant delays in the identification of recent outbreaks for multiple pathogens, including Ebola, Lassa fever, yellow fever and Zika, primarily due to poor local diagnostic capacity. In the case of the 2013–2016 Ebola epidemic in West Africa…postoutbreak analyses suggest that diagnosing 60% of patients within 1 day instead of 5 days could have reduced the attack rate from 80% to nearly 0%. In the end, it was diagnostics information coupled with appropriate interventions that led to eventual containment of the outbreak, but the delays resulted in the loss of thousands of lives and billions of dollars in the cost of response.”

It is clear that long-term benefits come from a thorough testing culture, and the challenge going forward is to deliver the latest innovations at affordable prices. I want our regulations to help manufacturers rise to this challenge, and to leave a diagnostic legacy that does not just improve our everyday health but makes us more resilient in dealing with winter flu and challenges in the decades ahead.

--- Later in debate ---

[Ms Dorries]

I was furiously trying to write down all the questions, because there were a lot in rapid succession. I am afraid I did not get them all down—the hon. Member was too fast.

Why now? I think I have said before to the hon. Member in Committee that we started at zero. We started with nothing—with no tests—when the global pandemic landed on our shores. It does not take a great deal of imagination to understand that we have been running to catch up, including by developing tests, Test and Trace, vaccines, isolation techniques and local management outbreak plans. The whole management of covid has been a mammoth effort.

The market is dominated by free tests from NHS Test and Trace, with the exception of tests for international travel. Obviously, there are exceptions. I am glad that the hon. Member noted what I thought was the most important part of my speech. There are other pandemic outbreaks that we can learn from, such as Zika, Ebola and yellow fever. The post-pandemic analysis shows us that if, in those examples, there had been more diagnostic post-pandemic testing, deaths could have been down to almost 0%. That is obviously where we need to move to. As we come out of the pandemic, we need to learn from the examples of pandemics of the past, and need testing that meets our high standards to be available to anyone or any organisation that needs or wants it. As I said, our standards are the highest in the world, and we will continue to maintain them.

Now is the time, coming out of the pandemic, when we need to put this in place, so that anyone or any organisation that wants to be additionally vigilant as we open up can be. The hon. Member asked me to confirm what Lord Bethell mentioned in a debate—I do not know when that was. Access to the NHS is part of the overall offer for individuals who want to access testing. However, businesses and private venues that want to put in place their own measures for the protection of their staff, for international travel and for opening up will also have access to tests.

I think the hon. Gentleman then asked another question; officials will have taken a note, and we will respond to him. On how we will ensure that test results are reported, it is a legal requirement that where a test is conducted by a testing provider, the result, whatever the outcome, be reported to Public Health England—or the UK health security agency, as it will be. This must be done within 24 hours, because covid is a notifiable disease; under the framework of that legislation, PHE has to be notified of any test result. We will know the results of those tests.

I am confident that the regulations are a proportionate and appropriate measure to ensure that all PCR and lateral flow tests available across the UK will, as I mentioned in relation to Porton Down, meet the same world-leading standard—a standard of which we should be proud. Being free to set our own regulations allows the UK to innovate, and to create agile yet strong regulations that can set new standards. Other countries will be watching how we do it. We have done it with vaccination; they will be watching how we manage post-pandemic, and how we manage testing. That new approach to regulation gives businesses seeking to enter the UK market the certainty they need, while providing strong safeguards for consumers.

British manufacturers and pharmaceutical research and engineering firms have led the way in the global effort to combat the virus, keeping the NHS supplied with kits, tests and medicines over the past year. The UK should be proud of how it has risen to the challenge of the pandemic. We have grown our diagnostics capability dramatically: we now have a total laboratory capacity of 6 million PCR tests. The Government have to date administered 214 million tests in total, delivering well over a million tests daily. The UK now has one of the largest diagnostics capabilities in the world.

We have also supported the growth of the private market through the accreditation of testing service providers. There are now more than 1,200 private providers of general testing, with the United Kingdom Accreditation Service administering the accreditation process. Regulating services is only half of the market; we must also regulate the goods side. We estimate that around 97 million CE-marked lateral flow device test kits reach the UK domestic market per week, and that capacity is growing. Because of that growth, it is important to get this regulatory regime in place now. We need to make sure the regulation is there to provide standards and to support growing markets, particularly in the arts and culture, and the workplace generally.

As we look forward to a future in which we can once again spend time with friends and family, enjoy the arts and sport, and work and shop as we once did, we must remain vigilant against the virus. It will still be there. We all have a part to play in keeping each other safe, and we have a duty towards our families, friends and colleagues. Testing is vital to that new paradigm. No one wants false negatives, which cause people unknowingly to allow the virus to spread. A mandatory validation scheme will not limit the supply of high-quality tests. Rather, the policy will ensure that poorly performing test kits that would not have helped our collective effort to combat covid-19 can be identified and removed from the market. They simply will not pass the test.

I regret that we are considering the regulations without an accompanying impact assessment and opinion. The timescales have meant that we have not yet been able to produce an IA with which the Regulatory Policy Committee is content. We continue to work with the RPC to ensure that we have a robust assessment of the impact for inclusion in the business impact target, although we accept that that assessment will come too late to have been of use in this debate. I am grateful to the RPC for the effort it has put into accommodating our timescales. We are working so thoroughly on the evidence and analysis for the IA, as the Government are clear that we want to be a world leader in agile regulation. This will likely encourage businesses to locate more research and/or manufacturing in the UK. It is clear that the regulatory regime that we are debating will provide only benefits for the safeguarding of public health, and certainty for businesses.

To some, this may seem a radical intervention in the market, but I am reminded of John Snow, the father of epidemiology. When the evidence is clear and change is needed quickly, radical action is no vice; it is a virtue. That change could be as simple as removing a pump handle, as Dr Snow did to prove that the source of cholera was in London’s water supply, or acting to ensure consistent standards that bring the best of business creativity to bear for the public good. This is the benefit of agile regulation. It does not force businesses on to particular paths of innovation, constraining them with costly rules that deter risk-taking. Instead, it adapts to keep consumers safe.

Having been on various Statutory Instrument Committees over the 17 months of the pandemic, I can say that this is one of the more positive SIs that I have had the pleasure to present, knowing as I do that it will bring about collective good and assist us with our post-pandemic preparedness.

Question put and agreed to.

Independent Medicines and Medical Devices Safety Review

Nadine Dorries Excerpts

Thursday 8th July 2021 Commons Chamber

[The Minister for Patient Safety, Suicide Prevention and Mental Health (Ms Nadine Dorries)]

I thank the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) and my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) for securing this debate on the implementation of the recommendations of the independent medicines and medical devices safety review.

Hon. Members have spoken passionately across a range of issues mentioned in the review, but before going into the detail of the recommendations I want to make a number of main points. First, the hon. Member for Bolton South East (Yasmin Qureshi) raised that issue of Primodos with huge passion again today, but I am afraid I have to rebut her criticism. I am not allowed as a member of the Government to discuss an issue that is sub judice and that is a live litigation in the courts at the moment; I am simply not allowed to do that. I have made this point a number of times and cannot make it much clearer: as a Government Minister, I am not allowed to discuss something that is in the process of live litigation.

[Yasmin Qureshi]

Will the Minister give way?

[Ms Dorries]

I will not, as I am about to move on to the other matters raised. I would also say that as a Government we make our decisions on the basis of scientific recommendations, and the scientific evidence provided to us at this moment in time does not support there being a causal link between Primodos and adverse outcomes in pregnancy. I am afraid that is all I am allowed to say. So on Primodos I say to those who have raised the matter that I hear everything they say and I hear the issues, but because it is sub judice I am not allowed to comment.

[Yasmin Qureshi]

Will the Minister give way?

[Ms Dorries]

I will give way, but I am afraid I will not be allowed to comment.

[Yasmin Qureshi]

I thank the hon. Lady for giving way. I heard both the points she made, but would the victims be compensated if the legal proceedings were withdrawn, or is this issue about the expert working group still going to be an obstacle?

[Ms Dorries]

I apologise, but I cannot answer the question.

Moving on, I want to address sodium valproate, in general terms now and later in more detail. I have heard the speeches today and some pertinent points were raised, and I would like to make an overall point on valproate again before going into the recommendations: valproate is a drug that saves the lives of women who can receive no other treatment for their epilepsy. Some women suffer life-threatening epileptic fits of such severity that only sodium valproate can save them; their lives would be lost if they did not take sodium valproate. Therefore it is not possible to ban the use of sodium valproate, because those women’s lives would be compromised.

A number of changes have taken place, too. A letter was sent out to women taking sodium valproate to make sure they were aware, and other measures have been put in place, which I will discuss in a moment, including ensuring that prescriptions for sodium valproate go into one box rather than being partial prescriptions, and the boxes have very clear and significant warnings on them. I could go into further detail, but the inquiry covers—

[Emma Hardy]

Will the Minister give way?

[Ms Dorries]

No, because the hon. Lady will be able to respond at the end of the debate and, without going into a huge amount of detail, I want to address a number of overall points that I feel can be made clear.

First, I thank Baroness Cumberlege for her report, of course. She is sitting in the Public Gallery—watching over me, as she does every day. I am delighted and not surprised that she is here, and we are all grateful to her. The report was commissioned by the then Secretary of State, my right hon. Friend the Member for South West Surrey (Jeremy Hunt), in response to public concern. It examined how the healthcare system in England responded to reports about harmful side-effects from the three specific subjects discussed today. Baroness Cumberlege was asked to chair the review. It is just not possible to do the review justice. It took two years, it was incredibly thorough, and it listened to so many voices on so many complex issues. It is not possible to do this overnight. No review undertaken by any Government on issues as serious as these has been implemented rapidly. They take a lot of discussion, time, evaluation and implementation by the NHS.

The review was published on 8 July 2020 and contains nine strategic recommendations that have wide-ranging implications for the healthcare system. That is why it is not possible to implement them rapidly. I pay tribute to the women and families who bravely shared their experiences and brought these issues to light.

Recommendation 1 was an apology. A year ago, I made that apology, and I will make it again. Having met the patient reference group members, spoken to those who have been harmed and read the report, which makes very harrowing reading, I want to make that apology again. I am desperately sorry. I have heard the stories of harm, which are harrowing. I am desperately sorry for those women who have been harmed. Of course, we all want to ensure that this ends and never happens again. The Government absolutely recognise the need for effective patient engagement to begin to rebuild trust and to ensure that we get the implementation right. That is why we established the patient reference group to work with the Department to develop this response. My officials and I have met the group regularly to gather their insights and to ensure that patient voices are heard as we progress towards a full response, which will be given in this place at the Dispatch Box before the end of this year.

Some Members said that none of the recommendations have been implemented or that we have not paid attention to them. That is simply not true. Recommendation 2 was on the establishment of a patient safety commissioner. I happen to know from discussions with Baroness Cumberlege that it was a prime concern for her that we established that role. As part of the written ministerial statement that I published in January, I announced that the Government had tabled an amendment to the Medicines and Medical Devices Bill before the Christmas recess to establish the role of an independent patient safety commissioner in line with recommendation 2. That is now in law under the Act. The commissioner will promote the safety of patients who use medicines and medical devices by ensuring that the views of the wider public about them are heard. There would be absolutely no point in having a patient safety commissioner if the role was not fully independent. That is what we are working on putting in place now. A public consultation is currently open and running until 5 August. I urge all Members who have spoken today and have constituents who have been affected to respond to that consultation to make sure that their views are known.

Recommendation 5 was on specialist centres, which are in place. There are eight specialist centres, and another will be opening in the south-west of England very shortly. Recommendation 6 was on reform of the Medicines and Healthcare products Regulatory Agency. I have announced that the MHRA has begun a substantial programme of work to improve how it involves patients in all aspects of its work to reform the system. Recommendation 7 was on establishing a medical device information system, again through the Medicines and Medical Devices Act 2021. In line with Baroness Cumberlege’s recommendation, this will mean that the NHS can track patients’ outcomes and spot issues. Work is under way to build, test and cost options on how a medical device information system could be embedded into the UK healthcare system.

Turning to the recommendations that we do not accept, I was honest when I stood here and said how desperately sorry I was and how harrowing those stories were, and I am not going to stand at this Dispatch Box and say that we are reviewing all the recommendations, which is what has happened in the past. I will be honest: we are not going to accept the redress agency in recommendation 3, or the taskforce. No Government have ever asked someone to chair or undertake a review and then asked those who conducted the review to implement the recommendations on behalf of the Government. That has never happened before. It is the responsibility of the Opposition to hold me to account and it is our responsibility as Ministers to implement the recommendations that the Government see fit to implement.

The Cumberlege report is a document that vividly shows the importance of patient safety and of listening to women. It is incredibly important that we listen to women. I am delighted that many people today have highlighted the adverse situations that many women experience, suffer and have to endure because they are women. It is absolutely right to say that many women are not listened to, and the hon. Member for Central Ayrshire (Dr Whitford) also made that point. This was the substance of the report by Baroness Cumberlege. Women are not listened to, and they have not been listened to. The women’s health strategy was not a recommendation but it was seriously influenced by Baroness Cumberlege’s review. That is why I established the women’s health strategy, and 112,000 women responded. It was not one of the recommendations, but we implemented it because women’s voices have to be heard.