Surgical Mesh

Fiona Bruce Excerpts

Thursday 19th April 2018 Commons Chamber

[Fiona Bruce (Congleton) (Con)]

I echo the comments of many hon. Members and express my deep concern for all women who have experienced debilitating and sometimes severe pain and discomfort following the use of vaginal mesh. In all our considerations of the use of such devices, their health, safety and wellbeing must be our first concern.

I welcome the Government’s recent announcements of Baroness Cumberlege’s review of the use of vaginal mesh and two other areas of medical safety—the use of valproate and Primodos. I was in the Chamber when the Secretary of State for Health announced that review on 21 February and I could tell from the tone of his announcement, not just the content, that he personally cares very greatly about the women affected by this issue. He wants to ensure that lessons are learned wherever possible, so that care can improve to ensure that each woman gets the treatment that is right for her—the best that can be provided for her as an individual. I am sure that the Minister shares that view.

The Secretary of State said:

“It is an essential principle of patient safety that the regulatory environment gives sufficient voice to legitimate concerns reported by patients, families and campaigners, works alongside them and responds in a rapid, open and compassionate way to resolve issues when these are raised.”—[Official Report, 21 February 2018; Vol. 636, c. 166.]

Ministers want to ensure that we do better in future where necessary, and to ensure that patient voices are brought to the table. I support the review and I want to ensure that justice is done for all women who have concerns about the use of vaginal mesh. We need to ensure that we maintain public confidence.

[Chris Elmore (Ogmore) (Lab)]

On the hon. Lady’s comments about justice being done, I have been approached by two constituents who have been greatly affected by vaginal mesh. One of them is unable to work. She has to be lifted up to walk as she cannot stand by herself, so she needs carers. Does the hon. Lady agree that in many cases it is not only justice that is needed, but compensation? As the Chair of the Health Committee said, we need to start looking at compensation for some women. My constituent is in her early 50s and can no longer work.

[Fiona Bruce]

That is something that I have said not only about this issue, but about the use of valproate. It is important that we pay close attention to the experiences and difficulties that patients have endured. We need to be more open to learning what we can from their experiences, making changes where necessary and—as the hon. Gentleman says—examining where compensation should be sought for them.

Baroness Cumberlege has been instructed to look comprehensively at the whole issue. The Government want to listen. We have all seen examples in which people have appeared to listen to concerns, nodded their heads and then gone away and done nothing. That is not what is happening here. I believe that the Secretary of State and Ministers not only want to listen carefully to concerns on this issue, but stand ready to act appropriately. For that reason, I think the proposal in the motion for a full public inquiry is inappropriate at this stage. We need to give time for Baroness Cumberlege to report. We need to urge that that be done urgently, and we need to ask Ministers questions.

I have some questions of my own for the Minister. What is the timescale for the review and what progress has been made already? Does the Minister agree that introducing an outright ban would be inappropriate before the review? Can she assure the House that the new NICE guidelines which recommend against first use of the surgical mesh to treat pelvic organ prolapse are being carefully followed throughout the NHS? Is it correct that in the vast majority of instances the use of surgical mesh has proven to be an effective intervention that has enabled many women to live happily and independently after surgery? I believe that some 1,500 women receive vaginal mesh implants each year and the majority respond well. If that is correct, it is important to balance that against the distressing individual cases that we have heard about today. I also understand that the high rate of success for the use of surgical mesh to treat hernias suggests that an outright ban would be rash at this stage, and certainly premature before the Cumberlege review reports.

What information can the Minister provide on the recent development of a new material for surgical mesh implants? What more information do we have about how that is expected to reduce discomfort because of its greater likeness to human tissue? Can the Minister update the House on what progress is being made to improve GPs’ awareness of SUI and POP and how best to treat those conditions, so that women are given the most appropriate treatment for their circumstances? Will the Cumberlege review take into account international research on this issue? We have heard some mention of it today, but I understand that no other jurisdiction has imposed an outright ban on the use of mesh.

In conclusion, the Secretary of State has made it clear that we are building on substantial work from over the past few years—the Cumberlege report comes on the back of a lot of other work, and I hope the Minister will confirm that that will all be taken into account. I ask Members to await that report before we make any final decision. Professor Keith Willett brought forward the 2017 Mesh Oversight Group report, which followed the Mesh Working Group interim report in 2015. He said that

“there has been significant progress since this work began. Information available to women and clinicians is now better and more consistent, data recording has been improved, including of complications, and women can now be referred to multi-disciplinary teams of health professionals with the experience necessary to advise women who are experiencing complications from mesh surgery on their treatment options.”

John Wilkinson, Director of Devices at the Medicines and Healthcare Products Regulatory Agency, stated:

“We continue to see that evidence supports the use of these devices in the UK for treatment of the distressing conditions of incontinence and organ prolapse in appropriate circumstances.”

We must ensure through this review that every circumstance in which these devices are used is appropriate, and that the women involved feel confident of that.

Mental Health Services: Children and Young People

Fiona Bruce Excerpts

Thursday 8th March 2018 Commons Chamber

[Mr Speaker]

Order. Many right hon. and hon. Members are seeking to catch my eye, but I remind Members that there are business questions immediately after these exchanges, followed by an important statement by the Home Secretary. Thereafter, the debate on International Women’s Day is heavily subscribed, so there is a premium on brevity from Back and Front Benchers alike, and I want to move on, whether we have incorporated everybody or not, no later than 11 o’clock. Single-sentence questions are much to be preferred.

[Fiona Bruce (Congleton) (Con)]

I commend the Government for promoting the Emotionally Healthy Schools project, which, in my constituency, is working well and engaging not just children who have challenges, but their families. Does the Minister agree that helping children with their mental health challenges needs to involve, wherever practical, their families, family relationships and inter-parental relationships, as recommended by the Early Intervention Foundation?

[Steve Brine]

As ever, my hon. Friend makes a point about families. I said that we are already rolling out mental health first aid training to every secondary school, which is of course important, and we are also committed to rolling out mental health awareness training to all primary schools by 2022, but to coin a phrase, it takes a village. This is about the state—of course, schools are part of that—but also the third sector, which has an important role to play. It is also absolutely about the love, support and Christian embrace of families.

Medicines and Medical Devices Safety Review

Fiona Bruce Excerpts

Wednesday 21st February 2018 Commons Chamber

[Fiona Bruce (Congleton) (Con)]

I thank the Secretary of State for the compassionate tone that he has struck today, and for taking account of the years for which many campaigners, such as Janet Williams and Emma Murphy, have tried to make their voices heard, on valproate in particular. If, following the review, various medicines or medical devices are found to be unsafe—or, indeed, to have been taken unsafely—will there be legal consequences for the regulators who should have acted differently?

[Mr Hunt]

The simple answer to that question is yes: there are legal consequences for regulators who have failed. In that instance, it would be the responsibility of the Government, or of the drugs companies who failed in their responsibility to inform patients of the dangers of taking drugs. The priority is to establish the facts. Some of those are clear now, but some are not, and that is why I think that the review will help us.

Acute and Community Health

Fiona Bruce Excerpts

Thursday 8th February 2018 Commons Chamber

[Stephen Barclay]

I referred earlier to my desire to work on these issues with members of the Health Committee, who include my hon. Friend, and I shall be happy to look into the points that he has raised. The previous statement was about the culture in the House of Commons. I think that what goes to the heart of my hon. Friend’s question and the matters that we are discussing is that issue of culture, and the need for the culture in pockets of the NHS to change. My right hon. Friend the Secretary of State has done a great deal to bring about such change, particularly in respect of patient safety, but I shall be happy to work with my hon. Friend to take that further.

[Fiona Bruce (Congleton) (Con)]

What lessons can be learnt by Liverpool Community Trust—and, indeed, by other underperforming trusts—from the successful turnaround of some 20 trusts under the Government’s new special measures scheme?

Oral Answers to Questions

Fiona Bruce Excerpts

Tuesday 6th February 2018 Commons Chamber

[Chris Skidmore (Kingswood) (Con)]

rose—

[Fiona Bruce (Congleton) (Con)]

rose—

[Mr Speaker]

Order. We might hear from the hon. Member for Kingswood (Chris Skidmore) later, but I say to him in all friendly courtesy that while Kingswood no doubt has a great deal to be said for it, as does Congleton, both have one thing in common, and that is that they are a very long way from northern Lincolnshire.

Abortion Act 1967: 50th Anniversary

Fiona Bruce Excerpts

Monday 6th November 2017 Commons Chamber

[Diana Johnson]

Clearly, 50 years ago Parliament took the view that it was going to allow abortions to take place in certain circumstances. It is right and proper that there is strict regulation around abortion. When I discussed decriminalisation earlier in the year, I talked about decriminalising, not deregulating. All providers have to provide the highest-quality care to women.

Successive British Governments have failed to act to improve abortion provision. They have sometimes hidden behind the false pretext that issues of provision are issues of conscience, thereby setting the issue aside as too difficult to tackle. In the months before and since I introduced my ten-minute rule Bill, yet more compelling evidence has demonstrated the need for long overdue changes to our abortion laws. Women, including desperate victims of domestic abuse, are increasingly ill-served by our current laws and criminalised for buying abortion pills online.

Waiting times for abortion services appear to be on the rise. Recently, figures obtained by investigative journalists at “The Debrief” showed that in 76% of the clinical commissioning groups and NHS trusts they surveyed, average abortion waiting times in 2016 were higher than they were in 2013. The Family Planning Association tells women that they should have to wait only 10 working days for an abortion, but a quarter of CCGs and trusts have average waiting times longer than that. In my local CCG in Hull, waiting times have jumped 6.7 days in just a year—one of the highest jumps identified.

The number of abortion pills seized by the Medicines and Healthcare Products Regulatory Agency posted to addresses in Britain has risen seventy-fivefold, from just five in 2013 to 375 in 2016. From November 2016 to February 2017, Women on Web, an international organisation that prescribes abortion pills in countries where abortion is illegal, monitored the number of British women who sought help on its website. In the space of just four months, the number seeking help had doubled.

Those figures point to this conclusion: there is a rising, and unmet, demand for better abortion provision in this country.

[Fiona Bruce (Congleton) (Con)]

Will the hon. Lady give way?

[Diana Johnson]

I am going to carry on, because I am conscious of time.

The personal cases of these women are often deeply moving. A recent study of Women on Web’s services, published in September, has provided unprecedented insight into the challenges that British women face in accessing abortion services. Of the women who approached its service, nearly one in five did so because of “controlling circumstances” at home—from abusive partners to intolerant families. As one woman told the service:

“I’m in a controlling relationship, he watches my every move. I’m so scared he will find out, I believe he’s trying to trap me and will hurt me. I can’t breathe. If he finds out, he wouldn’t let me go ahead, then I will be trapped forever. I cannot live my life like this.”

Another said:

“I’m never allowed to go anywhere without my husband or a member of his family escorting me. I don’t have a normal life since getting married. Abortion is against his family’s religion and I’m very worried what would happen if I was caught.”

For many women, making two trips to an abortion clinic, as is currently required, is simply not an option. A range of practical factors—the distance they live from a clinic, delays in accessing support, and childcare and work commitments—prevent them from making those trips. Yet each time these women purchase pills online, they are committing a criminal act, and because Women on Web does not prescribe pills in the UK, they are forced to turn to other providers, some of which may not be legitimate.

We are now in the position where the Royal College of Obstetricians and Gynaecologists, the British Medical Association and the Royal College of Midwives, plus the noble Lord Steel all agree that the law needs to be updated, and that abortion should be decriminalised. It is now time for Parliament to act on this. Shortly, I will be publishing the text of a Bill to decriminalise abortion in England and Wales. I am currently working on the Bill with legal experts and professional healthcare organisations. The Bill will contain the same safeguards and regulations as those that I set out in March this year.

Most importantly, it will take women out of the criminal law altogether. Healthcare professionals who assist in abortions before 24 weeks’ gestation will also be decriminalised, and they will receive further protections after 24 weeks. It will also allow us to make the best possible provision for the women who have early medical abortions. We need to look at the requirement to obtain two doctors’ signatures. We should also ask whether the second abortion pill could not be taken at home should women wish to do so, just as it is in the United States, France, Sweden and, as announced recently, Scotland.

[Fiona Bruce]

Will the hon. Lady give way?

[Diana Johnson]

I will carry on, because I am conscious that the Minister has to respond.

I want to make the point that decriminalisation will not mean deregulation. The 24-week time limit will not be changed, and the conditions for accessing abortions post-24 weeks will not change either, but I do want to see stronger protection for women from non-consensual abortions—whether by assaulting pregnant women, or deceiving women into taking abortion medication.

I have a few requests for the Minister. It is time that we acknowledged that abortion provision is not a conscience issue. Access to abortion services is a core part of women’s healthcare. It should be debated in a grown-up way, and Health Ministers should be held accountable for the quality of our abortion services. First, will the Department of Health look into the problems that women are facing in accessing abortions? The Department should be regularly assessing the problem of abortion waiting times. It should be looking to identify local areas where there is poor provision. The problems that extremely vulnerable women face in accessing abortion care should also be investigated.

Secondly, what concrete steps will the Government take to improve abortion provision? A court judgment in 2011 established that the Health Secretary could allow home use of the second abortion pill without the need for new legislation. In the light of that and of what has happened in Scotland, what are the Government planning to do? Furthermore, an increasing number of experts have questioned the two doctor requirement for early stage abortion. Will the Minister comment on that?

Thirdly, how will the Government respond to the calls to decriminalise abortion, supported by three professional medical bodies? Will the Government consider acting on these calls? Finally, we must also recognise the situation in a country where the Abortion Act does not apply. In Northern Ireland, abortion is highly restricted and criminal, even in cases of rape, incest or fatal foetal abnormality. The ongoing Supreme Court case raises the prospect that this may soon go beyond a devolved matter and become a broader human rights matter. What steps are the Government taking for that to be dealt with by the Secretary of State for Northern Ireland?

In conclusion, the House should mark the anniversary of the Abortion Act—not just because of what we have achieved, but to look forward to what we need now. In the face of threats to women’s reproductive rights at home and abroad, the answer is not to become timid and to remain defensive. The answer is to be bolder, to go beyond merely defending what we currently have, and to make a positive case for stronger rights and better women-centred provision. The ’67 Act made Britain a world leader in women’s reproductive rights, but it is time that we took the steps now to ensure that, once again, Britain reassumes this world-leading position.

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

I congratulate the hon. Member for Kingston upon Hull North (Diana Johnson) on securing this debate to mark an historic occasion: the fiftieth anniversary of the passing of the Abortion Act 1967. As the hon. Lady explained, the Act was introduced as a private Member’s Bill by the then hon. Member for Roxburgh, Selkirk and Peebles—now the right hon. the Lord Steel of Aikwood—and clearly defines the grounds under which an abortion may be carried out in England.

With the exception of emergencies, when it is necessary to perform an abortion to save the life of the woman, two doctors must certify that, in their opinion, which must be formed in good faith, a request for an abortion meets at least one ground set out in the Act, and they should be in agreement as to which ground this is. The hon. Lady asked whether it should remain the case that the opinions of two doctors are required. Well, as long as that remains the law—clearly it is—my emphasis, from a Minister’s perspective, is on delivering the safest possible treatment for women in accordance with that law. The hon. Lady also raised some important issues regarding waiting times, which I would like to go away and reflect on. I am sure that everyone in this House agrees that no woman undertakes a termination lightly. For many, it is extremely traumatic, so it is incumbent on all of us to make that experience the least painful and least traumatic it can be, and as safe as possible. Central to being as safe as possible is that it takes place as early as possible.

[Fiona Bruce]

The Minister is talking about the requirement for two medical practitioners to give their agreement. A ComRes poll of 2,000 adults last week showed that 72% of the public think that abortions should continue to be subject to that legal requirement, because it ensures protection for women, particularly for those in an abusive relationship. It might be the opportunity they have to talk to someone in a safe environment about the pressure that they might be being put under to have an abortion.

Valproate and Foetal Anticonvulsant Syndrome

Fiona Bruce Excerpts

Thursday 19th October 2017 Commons Chamber

[Fiona Bruce (Congleton) (Con)]

I pay tribute to the right hon. Member for North Norfolk (Norman Lamb) for so eloquently articulating the concerns that many of us share about the taking of sodium valproate by expectant mothers.

I am speaking today because I believe there is a case for Ministers to answer on the grounds of compassion and justice as to how and why pregnant women were allowed to take sodium valproate for so many years without being better advised and informed, and without their unborn children being better protected from the risks. That is particularly the case since professionals became increasingly aware of those risks over the years—as early as 1973. As we have heard, the risks are huge. At the end of the day, the people who should have been able to weigh them up and choose whether to take valproate while pregnant were the mothers. I appreciate that in 1973 we were, as has been said by a practitioner in medicine, in a more paternalistic era, but that was not the case as the years went by, and certainly not in 2016, when the valproate toolkit—the patient guide that I have here in my hand—was published.

Mothers were not given the relevant information and, sadly, far too many still are not. It is absolutely critical that they are given it, because the toolkit is stark, stating:

“If you take valproate when you are pregnant it can harm your unborn child…Taking valproate…can cause birth defects and problems with development and learning…In women who take valproate while pregnant, around 10 babies in every 100 will have a birth defect”,

such as

“spina bifida…facial and skull malformations…malformations of the limbs, heart, kidney”

and other organs. It goes on to say that

“about 30-40 children in every 100 may have developmental problems”

such as

“learning to walk and talk…lower intelligence…poor speech and language skills”

and “memory problems.” It states that

“it is…important that you…know about these risks”.

But for years women did not know about the risks when medical professionals did. They might not have known, and probably did not know, all those details. However, I have with me a copy of a letter from the Committee on Safety of Medicines—the precursor to the MHRA—from 1973. It refers to a number of studies and says:

“it is now clear from other studies…that the use of anticonvulsants during pregnancy…is liable to produce other abnormalities as well as hare-lip and cleft palate. The risk appears to be low and not sufficient to justify stopping the use of anticonvulsants when they are necessary for the control of epilepsy.”

There we have it—the Committee on Safety of Medicines was aware of this in 1973. The documentation relating to the licensing application in 1974, which the right hon. Gentleman mentioned, says that the product is licensed

“for use in general, focal or other epilepsy. In women of child bearing age, it should only be used in severe cases or those resistant to other treatment”.

So we now know that the dangers were being raised as long ago as 1973 and 1974.

In response to these concerns, the CSM instructed that an alert must

“not go on the package inserts”

so that patients would be protected from “fruitless anxiety”. Because patients did not see anything, they were denied the information and therefore the choice to abstain from this drug. Yet very much more anxiety was caused for many of them when the reality was that thousands of babies were born with life-changing disabilities and deformities that could have resulted from taking this drug during pregnancy.

[Teresa Pearce (Erith and Thamesmead) (Lab)]

Does the hon. Lady find it even more shocking that it was decided to keep this information from women in 1973-74, in the wake of the thalidomide scandal, when it should have been uppermost in people’s minds that pregnant women needed warning about the drugs they took? That should have made it more likely that women were informed about the risks.

[Fiona Bruce]

The hon. Lady makes a very good point.

Further warnings were issued. In 2000, a patient information leaflet from the producer, Sanofi, said:

“It is known that women who have epilepsy have a slightly higher risk of having a child with an abnormality than other women. Women who have to take Epilim in the first 3 months of pregnancy to control their epilepsy have about a 1-2% chance of having a baby with Spina Bifida.”

In 2005, Sanofi added:

“Some babies born to mothers who took Epilim during pregnancy may develop less quickly than normal and may require additional educational support”

and that some

“babies born to mothers who took Epilim…during pregnancy may develop less quickly than normal or have autistic disorders.”

Warnings were emerging over the years, but nothing was done to ensure that patients were told. Why did patients have to wait almost 30 years to be warned of the risks?

Janet Williams and Emma Murphy, whom the right hon. Member for North Norfolk (Norman Lamb) mentioned and whom I have had the privilege of meeting, are tenacious and brave women who have campaigned for years and set up a support group for affected families. I pay tribute to them, and I want to tell the House a little bit about their family situations. Janet has two sons aged 26 and 28: Lee and Philip. Janet took Epilim, but nothing else, during both pregnancies. She told me:

“I wasn’t offered anything else—and no one told me of the risks.”

Lee, at 26, has curvature of the spine, Asperger’s, learning difficulties and memory problems, and he cannot hold down a job. Philip, at 28, has even more problems. He has problems with hearing, vision, speech, language and walking, as well as floppy joints. He is still fully dependent on Janet.

Emma had her children a generation later. She has five children, aged eight to 14: Chloe, Lauren, Luke, Erin and Kian. They have all been diagnosed with a number of symptoms. All have varied problems, including autism, incontinence, deafness, cerebral palsy and curvature of the spine, and all are slow to develop. Emma took the same dose of Epilim during each pregnancy. She told me that she questioned that, but was told that it was the best drug to control her seizures and that her baby would be fine. She took no other drugs during her pregnancies. No one warned her of the risks.

The tragedy is that those two women represent more than 1,000 others in their support group, the Fetal Anti Convulsant Syndrome Association. Together, they founded the Independent Fetal Anti Convulsant Trust, a registered charity, to campaign for better awareness of the risks of taking valproate, to prevent further such difficulties occurring, and to challenge the Government. There is, as I say, a case to answer, and I do not believe that we would be here today were it not for these two women.

[Rosie Duffield (Canterbury) (Lab)]

Does the hon. Lady agree that women such as Janet and Emma are ideally placed to get compensation, should the Government agree to a system similar to the €10 million French compensation scheme for Depakine?

[Fiona Bruce]

I certainly think that has to be looked at as part of the case that Ministers have to answer.

I would like to say much more but time prohibits me. We have heard some of the terrible statistics that have already been cited about the 20,000 children who could have been affected since the risks were first known about, the 400 children who are still born each year with symptoms, the 28,000 women of childbearing age—according to ONS figures—who are still being prescribed the drug, and the 68% of women in this situation who say that they are not properly informed of the risks.

What do I ask of Ministers? I ask the Minister to agree that significantly more needs to be done urgently to raise awareness of the risks of taking sodium valproate among pregnant women and those who could become pregnant. Does he agree that although Ministers might have come to know about the risks only relatively recently, the producer Senofi, the MHRA and its predecessor, the Committee on Safety of Medicines, knew about them and should have done more to address them? They should have published information and improved warnings years ago.

Does the Minister accept that the support needed by mothers such as Janet and Emma, who have to care for their children with foetal valproate syndrome, is major and may be lifelong, and that much more needs to be done to consider how that support can be improved and funded? Janet and Emma tell me that the current provision through local councils and health authorities is wholly insufficient and that care plans are needed for the many affected children.

Is there any reason why, as I said at the outset, Ministers cannot look at what we in this country can do to support these families now, without further delay, and certainly without awaiting the final decision of the European Commission regarding the link between sodium valproate and birth defects? After all, we are leaving the EU. Does the Minister now have full confidence in the MHRA’s ability to effectively inform and guide healthcare professionals on the use of the prescription of sodium valproate for epilepsy, and does he think the same can be said of the MHRA’s involvement over the years? Finally, will the Minister, at an early date, meet Janet Williams and Emma Murphy, as well as a group of Members who are concerned about this issue, to respond to their concerns and to my call that our Government at the very least have a case to answer?

--- Later in debate ---

[Liz McInnes]

The hon. Lady is absolutely right. She and I are well aware of the yellow card system, because we have both worked in the NHS, but how many people out there know that they can report side-effects of drugs, or even suspected side-effects? We really have a job to do in conveying that message to the general public, and we also need people to collate the information and act on it.

A definitive paper stating that there was a clear link between valproate taken during pregnancy and birth defects was published in 1995. It was entitled “Foetal Valproate Syndrome”, and was written by geneticists at St Mary’s Hospital, Manchester. It is clear that the evidence has been building up for a long time, so why does it appear that women were not warned about the potential dangers of taking the drug in pregnancy?

[Fiona Bruce]

That 1995 report concluded that the “risk” of foetal valproate syndrome when babies were exposed to valproate was “significant”.

[Liz McInnes]

That was probably the first research paper to suggest that it was not just coincidence and that there was a causal relationship, which is why it is seen as definitive.

The pharmaceutical company Sanofi, which many Members have mentioned, has stated that it has kept in line with scientific knowledge when reporting side-effects in a foetus. However, from as early as 1983 the CSM and the MHRA reported the problems caused by taking sodium valproate in pregnancy, but did not insist that Sanofi issue warnings in the form of a patient information leaflet.

Even now, to this day, epilepsy charities report that women are not aware of the potential risks when taking the drug in pregnancy. A survey has shown—I know it has already been mentioned, but it does no harm to reinforce these findings—that 18% of women taking sodium valproate were not aware of the risks during pregnancy, and 28% said that they had not been informed of any risks. That is despite the production by the MHRA of a valproate toolkit designed to help healthcare professionals to talk to women with epilepsy about the risks of taking valproate during pregnancy.

Oral Answers to Questions

Fiona Bruce Excerpts

Tuesday 10th October 2017 Commons Chamber

[Mr Hunt]

Let me tell the hon. Lady what has happened in mental health. Some 30,000 more people are working in mental health today than when her Government left office—a 5.8% increase in clinical staff. On top of that —she asked about money—we have committed an extra £1 billion a year by 2021 so that we can employ even more people. We are the first Government to admit that where we are now is not good enough. We want to be the best in the world; that is why we are investing to deliver that.

[Fiona Bruce (Congleton) (Con)]

21. Parental conflict is recognised as a key cause of children’s mental health problems. What is the Department doing to address that, and will Ministers be willing to meet a group of colleagues who supported the “Manifesto to Strengthen Families”? Its policy proposals seek to discuss how strengthening families can address children’s mental health problems.

[Mr Hunt]

My hon. Friend is absolutely right. Children who come from troubled or chaotic family backgrounds are far more likely to have mental health issues. I am more than happy to meet her and to feed her thoughts into our mental health Green Paper.

Organ Donation: Opt-out System

Fiona Bruce Excerpts

Thursday 13th July 2017 Westminster Hall

[Fiona Bruce (Congleton) (Con)]

It is a pleasure to serve under your chairmanship, Ms Buck. I congratulate the hon. Member for Barnsley Central (Dan Jarvis) on securing the debate and on his sensitive and compassionate tone; I hope I can reciprocate. I agree with the hon. Gentleman that it is imperative to work to increase the number of organs available for donation, because every week people in this country die because there is a shortage of available organs. The critical question that we must ask today is whether presumed consent would help with that.

Presumed consent certainly seems an attractive proposition, but perhaps I may enter a note of caution, to aid our early deliberations on the matter. One of the key legal principles I was taught as a student lawyer was that silence is no reply, which means that, much as we might like to draw conclusions from silence, there are good reasons why it may be inappropriate to do so. Introducing the principle of presumed or deemed consent would involve a major change with respect to organ donation. It would effectively mean that even if someone did nothing at all—did not sign an organ donor register, or opt out or in—a consequence would be triggered. The person’s silence would trigger a quite major action. Their organs could later be taken and transplanted. Consent would be deemed, although they would have done nothing.

Of course, some people, on seeing the publicity that might surround the introduction of presumed consent, would deliberately and knowingly decide to do nothing, aware of the consequence; they would be comfortable with that. Those people would be aware that they had, in doing nothing, effectively chosen to donate. However, there would inevitably be a significant group of people who missed the publicity altogether. We need to be sensitive to that.

Informed consent is an important principle, undergirding the relationship between the citizen and the state, so it is right that the House should explore the issue carefully, which is why I welcome the debate. It is critical to explore whether, for example, it is right in this instance to undermine the principle of informed consent by introducing presumed consent. Is it possible that that could create a precedent that might be appealed to in future for less enlightened purposes?

Some practical concerns were highlighted during the debates in Wales that preceded the legislation there, some of which I did not feel were satisfactorily resolved at the time. When the Welsh Government made the case for introducing presumed consent, they based their case, at least in part, on a piece of research by two academics, Abadie and Gay:

“Evidence...suggests that introducing an opt-out type system could result in a 25 to 30 per cent increase in deceased organ donation rates which could equate to a further 15 donors each year in Wales, each of whom...on average might donate 3 organs. This means around 45 more organs could become available to the UK pool for transplantation.”

I understand that the research compared practices in other jurisdictions, and classified Spain, the country with the highest donation rate in the world, as a presumed consent country. Spain introduced presumed consent legislation in 1979, but the law has never been implemented; Spain is still in practice an informed consent jurisdiction like England. Indeed, rates of donation there started to increase only when, 10 years later, Spain made other changes, in particular investment in the organ donation infrastructure. It increased the capacity, training and availability of medical staff to talk to families about donating the organs of a loved one when a life has tragically been cut short.

A leading expert in the field, Professor John Fabre, unsuccessfully tried to point out to the Welsh Government their misconception. In an article entitled “Presumed consent for organ donation” in the journal Clinical Medicine, he referred to their explanatory memorandum, published in December 2012, to the Bill that became the Human Transplantation (Wales) Act 2013. It stated:

“For example, an opt-out system is operated in Spain and it has the highest donation rate in the world.”

As I have said, Spain, even today, does not operate an opt-out system, so I believe that that statement was incorrect, even though it was cited in official papers in Wales, underpinning the presumed consent legislation. The recognition that the country with the highest donation rate in the world does not in fact operate a presumed consent system is important in any assessment of the efficacy of presumed consent. It is also striking that some of the countries that are least successful with their organ donation rates, including Sweden, Greece and Bulgaria, operate presumed consent.

A second objection raised during the debate in Wales was the fact that in some countries the introduction of presumed consent has been associated with significant numbers of people withdrawing from donation. Some people interpret the introduction of presumed consent, despite its noble motivation, as the state seeking to claim their organs without proper consent. Rather than seeing it as a mechanism for donation, they see it as a mechanism for bypassing consent to donation. There has been some evidence of that in Wales. Giving oral evidence to the Health and Social Care Committee of the National Assembly for Wales, organ transplant specialist Dr Peter Matthews, who was based in Morriston Hospital in Swansea, said:

“My own experience is that the British psyche has a particular view that what it should do is donate organs as an altruistic gift, and if it is felt that the state is going to take over the organs, then there is the potential that people who may have been willing to become a donor will not do so. We have seen two cases in Morriston where patients who were on the organ donation register, on hearing about this, said to their families that if the state was going to take their organs, they were no longer willing to give them. We lost two donations”.

During the debate on the Bill in Wales, three Assembly Members relayed similar stories from constituents.

I want to comment on the impact of presumed consent in Wales. NHS Blood and Transplant records donations on a yearly basis, from April to April, and the first full year of results that we have from Wales is for 2016-17. The data tell us two important things: first, in 2016-17, 61 deceased donors facilitated 135 organ donations. Far from representing the anticipated increase of 15 donors and 45 organs, that apparently constituted a decline by three donors and 33 organ donations from the previous year’s figures. That might come as something of a surprise, because some people have suggested that the system was a great success. However, under informed consent a family can donate the organs of a deceased person if the deceased has signed neither the organ donation register nor the opt-out register, which means that, as we have heard, in Wales prior to December 2015 the families or living representatives of the deceased could—as they can here—decide to donate their loved one’s organs. But under presumed consent those informed consent donations would be reclassified as presumed consent donations. Critically, that does not mean that those donations would not have happened under the old system.

Secondly, and not surprisingly, bearing in mind what Dr Matthews told the Assembly, there has been a huge increase in the number of people in Wales opting out. In 2016-17, 174,886 people in Wales were on the opt-out register. That figure far outstrips comparable figures for other parts of the UK, where consent is not presumed. Only 27,559 individuals in England, 1,834 in Scotland and 204 in Northern Ireland have opted out. That means that a staggering 85.5% of individuals in the UK who have opted out live in Wales, despite the population of Wales representing only 4.8% of the UK population.

I have cited a lot of figures, but I do so to get them on the record and to aid our debate. To appreciate fully the cost of the change in Wales, we must remember that prior to the introduction of presumed consent, people who had signed neither the opt-out register nor the opt-in register were potential donors.

[Paul Flynn (Newport West) (Lab)]

Does the hon. Lady agree with the Welsh Government’s conclusion that 40 lives have been saved under the presumed consent scheme that would have been lost under the previous arrangement?

[Fiona Bruce]

My concern is to demonstrate that we have to look very carefully at some of the evidence that the Welsh Government used to come to their conclusions.

Where someone has signed the opt-out register, conversations cannot even begin. That means that more than 174,000 of the Welsh population have effectively been removed as potential donors. Previously, in the absence of express direction to do otherwise, those people’s families, as their living representatives, might have been happy to donate their loved ones’ organs at their death. When Wales embraced presumed consent, the other UK jurisdictions said that they would wait to review the results in Wales before deciding whether they wanted to go down that path. I ask the Minister to look at the evidence.

We have significantly increased donation levels in England since implementing the recommendations of the organ donation taskforce in 2008, which of course came down very much against presumed consent. Rather than seeking to emulate Wales, England should perhaps seek to emulate Spain and put its emphasis on lowering the family refusal rate by increasing the number of clinicians who are trained and available to discuss this issue with families when the need arises—often at short notice.

Professor Fabre concluded his seminal paper in Clinical Medicine in the following terms:

“Rather than legislating for the consent of donors, we should be addressing the misgivings and misunderstandings of families so that they decline donation much less frequently, as has been done so successfully in Spain. An acceptance rate of 85% is a realistic and achievable objective for the UK over a 5-year period. As previously, we have the Spanish model to guide us. It will not be easy. It will require…a detailed plan at the national level”.

I very much hope that the Minister will consider all those points and confirm that the Government will take into account every possible consideration and concern about this issue before any legislation is introduced. I look forward to her response.