PARLIAMENTARY DEBATE
Valproate and Foetal Anticonvulsant Syndrome - 19 October 2017 (Commons/Commons Chamber)

I beg to move,

That this House notes with concern that there has been a systematic failure to inform women of the dangers of taking the epilepsy drug sodium valproate during pregnancy, resulting in thousands of children being born with congenital malformations, disabilities and developmental disorders since the 1970s as a result of fetal exposure to the drug; welcomes the launch of the Valproate Toolkit by the Medicines and Healthcare Products Regulatory Agency in February 2016 to ensure that women are informed of the potential risks of the drug, but further notes with concern a recent survey which found that 68 per cent of women have still not received these safety warnings; calls on the Government to take immediate steps to ensure that the materials in the Valproate Toolkit are distributed to all prescribing clinicians, pharmacists, and women who are being prescribed the drug; calls on the Government to require all clinicians prescribing sodium valproate to women and girls of childbearing age to discuss annually with the patient, the risks during pregnancy before a prescription is renewed; and further calls on the Government to bring forward proposals for a care plan and financial assistance to the victims of sodium valproate in pregnancy and their families.

I congratulate you, Madam Deputy Speaker, on getting through this debate’s catchy title.

I start by thanking the Backbench Business Committee, on behalf of the all-party parliamentary group on valproate and other anti-epileptic drugs in pregnancy, for facilitating this debate. I also pay tribute to Janet Williams and Emma Murphy, who are present today. They have fought tirelessly on this cause over many years, and we owe them an enormous debt of gratitude.

It is fair to say that “scandal” is an overused word in political discourse, but it is appropriate in this case: a family who have suffered as a result of a mother taking valproate in pregnancy would regard it as an absolute scandal, and we need to treat it in that way. There are many similarities to the thalidomide scandal. A group of women, over many years, took a drug during pregnancy without knowing the risks, with awful consequences, and we owe them a duty—that is the important point.

I apologise to the right hon. Gentleman for not being able to stay for the whole debate.

I, too, pay tribute to Janet and Emma for the campaign they have run. This debate is a great tribute to their efforts. Does the right hon. Gentleman agree that the real scandal is that we have known about the problems with this drug since the 1960s, but, as he says, expectant women were not told? The Government and the pharmaceutical industry knew there were dangers.

I thank the hon. Lady for her intervention, and I completely agree with her. Interestingly, the original product licence in March 1974 stated this, way back then:

“In women of child bearing age, it should only be used in severe cases or those resistant to other treatments.”

They knew in the ’70s, yet the appalling scandal is that so many women since then have had their life turned completely upside down, with enormous consequences for their children, because they were not told.

My constituent Nicola took sodium valproate through her pregnancy, and her son has chronic fatigue. The impact on her family is immense and expensive. We have fought for, and managed to secure, medical support for her through hospitals in Manchester, but does my right hon. Friend agree that there needs to be a Government fund to ensure that victims have such support, rather than having to rely on their own means?

I completely agree. I will make the case a little later, but it seems unanswerable and the Government need to reflect on that.

What happened was worse than just the neglect of not telling women. The minutes from the 18 July 1973 meeting of the sub-committee on adverse reactions, a sub-committee of the Committee on Safety of Medicines, have been uncovered. That document reveals a real outrage, because it talks about keeping the information from women—deliberately withholding it

“especially as it could give rise to fruitless anxiety.”

It continued:

“Nevertheless, they thought it would be best if prescribers were all made aware of the nature of the evidence and recommended that a statement similar to that proposed by ICI”—

in respect of another product—

“could be included in all relevant data sheets but not on package inserts so that there would be no danger of patients themselves seeing it.”

That is extraordinary.

Would the right hon. Gentleman share my great disappointment if the original documents were to go missing from the archive while these debates and this campaign are ongoing?

I thank the hon. Gentleman for that intervention. Issues such as this are of enormous concern and this raises the question whether there needs to be some sort of inquiry or Hillsborough-style panel to look at exactly how it has happened. However, it is important that we focus on the top priority, which is ensuring that women get told, that this drug is not used inappropriately and that a compensation package of some sort is put in place.

Given what the right hon. Gentleman has said, is it not even more extraordinary that, even now, this information and these warnings are not getting through effectively to pregnant women and their families? My constituent David Tout’s son has been affected by this, as have 20,000 children across the country in every one of our constituencies. There is no sense of urgency from the MHRA—Medicines and Healthcare Products Regulatory Agency—or from the Government.

I thank the right hon. Gentleman for that, and he is right in what he says; I, too, feel that there is a sense of inertia. For goodness’ sake, for as long as women are not getting told about this, more such babies are being born. That is the awful horror of this.

Many of us in the House have been approached by constituents or groups about several of these drug scandals, which represent a paternalistic time, when the patient was not part of a team in an open discussion with the doctor. I am sure there are many of these, so should they be looked at together, as the principles of them all are the same?

That is a profound comment to make and it reflects a changing attitude and culture; it is thankfully now less paternalistic than it was. However, elements of it remain and we need to keep fighting against that. The hon. Lady makes a good point: this relates to other products, too.

I will take this intervention and then I ought to make progress.

Is the right hon. Gentleman aware of research done by the Independent Fetal Anti Convulsant Trust—In-FACT—which found that up to 400 babies affected by valproate have been born since the toolkit was launched in February 2016?

I thank the hon. Lady for the intervention. I am aware of that figure and again it is shocking. It makes the point that this is a continuing scandal, not something from the dim and distant past.

Since the 1970s, more information has emerged bit by bit. In 2000, the information given to patients was changed to refer to the warning, but it took until then for anything to emerge. In 2005, Sanofi made an addition to this, and an interesting question is whether it downplayed the risk. That is one point that raises the question whether some sort of panel investigation needs to take place. In 2005, Sanofi said on its warnings to patients:

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

That is putting it at its mildest, because the implications were far more serious. The question is, did it know then? These things need to be investigated further.

It is important to state what the risks are. Among the general population there is a 2% to 3% risk of foetal abnormality. If valproate is taken during pregnancy, that risk rises to 11%, and possible defects include spina bifida; malformations of the face, including cleft palate; malformations of the skull, limbs and organs, including the heart; and respiratory issues. It is incredibly important not to disregard the fact that when people take valproate during pregnancy there is also a 30% to 40% risk of developmental problems, including life-changing issues such as poor speech and language skills, delayed walking and talking, behavioural problems, interaction and communication issues, low intellectual abilities, memory problems, noise sensitivity, sensory issues, attention deficit hyperactivity disorder and autism spectrum disorders. The consequences are incalculable. It is estimated that 20,000 babies have been affected since the 1970s. It is also important to remember the profound impact on the mothers themselves, who too often have been treated as if they are to blame for the problems their children face and who then face years of guilt. That is a really shameful aspect of all this.

I have some case studies. Becky Parish, a mother from my own county, Norfolk, says:

“Logan is 7 and was born with a 7 mm unilateral cleft lip and palate…which the geneticist confirmed was due to Fetal Valproate Syndrome…He also has grommets and struggled with glue ear and bronchitis as a baby”.

He has needed “constant speech therapy” and suffers ear infections.

Becky describes how Logan

“has all facial features of FVS”

and is short in height and low in weight for his age. He has

“severe aggressional and destructive behaviours, including violence against others and self-injurious behaviours”

and so it goes on. This is really significant. There is sometimes a danger when we talk in general or abstract terms, but when we hear the stories of the affected families, we realise just how awful it is.

Becky says “social”—social services—“blamed me for it”. Her assertion is that in her case social services thought that the problems related to a detachment disorder, with the implication being that the mother was in some way to blame. She says:

“Social blamed me for it and so did the school—and now I feel more guilt due to it being FVS. Because no matter how much someone says I didn’t know and it wasn’t my fault, the guilt never goes away. And sadly it never will.”

That is really shocking.

Becky decided not to continue with valproate when she became pregnant with her youngest child, who is now five. She says that it was not a difficult decision, because in her view her child’s health was “far more important” than her own seizures, but that must have been a terribly difficult judgment for her to make. Nevertheless, she stopped straight away and was not put on any alternative treatment, despite conflicting messages from health professionals. Her specialist nurse told her that—wait for it—she was being selfish, and made her upset at her 12-week scan. However, her neurologist said that coming off the drug was the best thing she ever did. So she got two completely conflicting messages.

Carolyn Allen in Southampton talks about how her son requires support for a number of the effects of the condition, including deafness in his left ear, noise sensitivity, and speech and language delay. She says:

“He has been referred to portage, speech therapy, occupational therapy, ophthalmic, hearing clinic, physiotherapy, community paediatricians and has already had one operation to release his tongue tie.”

Just imagine the massive impact of this condition on that family.

Paula Hartshorn, a mother from Leeds, says:

“The powers-that-be need to think about the devastating impact this has on families, and how these families have to just cope and instantly know how to deal with all these complex medical issue. We have been left to give up on our jobs, careers, social interactions, and everything that goes with a well-rounded life. There are no breaks for us.”

The stories are heartbreaking.

Kazzy Southam from Blackpool tells a story of not finding out about the condition until her daughter was nearly 20. Her voyage of discovery began when she met Janet and Emma in 2014. This was after her daughter had been diagnosed with learning disabilities, dyspraxia, and social anxiety disorder. She had to fight to get a geneticist to investigate and give advice. Eventually, it was confirmed that her daughter had foetal valproate syndrome. It was a shocking fight for her to get justice, and she should not have had to go through that. She says:

“To me, she is an angel and I wouldn’t change her for the world. She said to me not long ago: I wouldn’t want to be ‘normal’—I like my mad head. But it hurts me to say, she doesn’t and won’t know any different—all down to the pills I took for my seizures.”

I ask Members to imagine living with that throughout their life. The Minister really needs to reflect on this. It seems to me that the Government have an obligation to do good by these people and not just to say that they must resort to the local authority or the clinical commissioning group for whatever might be available in their locality. There is a moral duty here and we must accept it just as we did with thalidomide.

I became aware of this scandal when I was a Minister and met the campaigners in September 2013. I was horrified by what I heard, having known nothing about the condition until then. I asked the Medicines and Healthcare Products Regulatory Agency, which attended the meeting, for an urgent review of what was being done to stop more and more mothers giving birth without knowing of the risks. In October that year, the MHRA asked the European Medicines Agency to undertake a full review. That review reached the conclusion—it was very little different from what the product licence said back in 1974—that the product should be used only if all other drugs are ineffective or are not tolerated. It also advocated a strengthened warning to ensure that all mothers were aware of the issue.

In January 2015, the MHRA issued new information with stronger warnings, education materials, patient information leaflets and so on. Eventually, in February 2016, the toolkit was issued: I have it here. It may not look like a toolkit, but it is. It is of value, because it gives information to clinicians and patients about the risks involved. Again, the scandal is that the information has not been communicated to very many of the affected women.

In September this year, a survey carried out by the UK’s three leading epilepsy charities—Epilepsy Society, Epilepsy Action and Young Epilepsy—found that the warnings were not getting through. Some 68% of women of childbearing age had not had any of the materials released as part of the valproate toolkit. That is not acceptable.

I thank the right hon. Gentleman for accepting a further intervention. He is making a very powerful case. The hon. Member for Central Ayrshire (Dr Whitford) mentioned the paternalistic approach that the medical profession has perhaps taken in the past. Is he as shocked as I was to learn that that paternalistic approach was still in evidence some two years ago when I met the pharmaceutical company Sanofi to discuss getting information out to mothers? The company told me that it would be inappropriate to make the information available, as it was unsupported by detailed advice from doctors. Of course it is important that women should be able to discuss the matter with their clinician, but they are able to understand and interpret intelligence, too.

I thank the hon. Lady for her intervention and pay tribute to her for her work on the all-party group for valproate and other anti-epileptic drugs in pregnancy, and for her campaigning. Yes, the response she got from Sanofi two years ago was unacceptable. It had the effect of hiding from women the full extent of the risk. Women should be presented with the evidence so that they can have a full discussion with the clinician about what steps to take. The September 2017 survey also found that 18% of women did not know of the harm—it was not that they had not received the toolkit, but that they still did not know. The system is failing those women.

I stand here as an advocate for my constituent, Ms Carol Short, who describes her son as a 26-year-old locked in a man’s body, but unable to do much more than a 10-year-old. Does the right hon. Gentleman agree that it is shocking, with the clinical commissioning groups and all the funding that comes from the public sector, that we still cannot get this message through? Might one solution be shorter length prescriptions, to increase the likelihood that women receive more regular advice?

That suggestion is worth exploring. There certainly should be regular reviews—discussions on the woman’s intentions about childbirth, and on the appropriateness of the treatment for that woman at that place and time.

I acknowledge an important danger. If all the focus is on the risk of valproate, there is a risk that women will simply give up and take no medication during pregnancy, and that there will be a rise in unexpected deaths through epilepsy. SUDEP Action raised that really important issue. Already, every year, 1,200 people die sudden unexpected deaths in epilepsy, and of that total SUDEP Action estimates that about 42% are avoidable. We definitely do not want any increase in that number. For me, that points to the need for all women—indeed, all people—with epilepsy to have access to specialist teams, wherever in the country they live. My worry is that access is haphazard and variable.

Last Friday I met a specialist team in Norwich. It is a very good team, and they explained to me how they have managed to reduce the use of valproate by women in the childbearing years to a very small number. They say it is only a very small subset, for whom there is no alternative. Thus they can focus all their attention on those women. They said that there is considerable variability around the country—that many women do not get access to a specialist team. I would like the Minister to commit to the publication by the Government of data for every CCG showing the level of prescribing of this medication, to enable us to pinpoint where over-prescribing is taking place.

The interesting and rather concerning point is, if those specialists that I spoke to are right that only a very small subset of women of childbearing age need to take valproate, why is it that still, of the 173,787 people with epilepsy taking valproate, 17,848 are women of childbearing age? That looks like substantial over-prescribing, which is completely contrary to the current guidance. If the guidance is clear that it should not be prescribed to women of childbearing age unless there is no alternative that is safe for the individual woman, why on earth are so many women still being prescribed this medication? It is a scandal, and the Government need to get to grips with it.

We need a holistic approach, so that women have access to specialist care and so that full consideration can be given to the right arrangements to ensure that no woman is on valproate who need not be during those years of childbearing age. Then we might start to see an end to this awful continuing scandal.

Finally, I shall outline the steps that the Government and others should take. First, the toolkit must reach everyone. It must surely be mandatory, not voluntary. Given the clear evidence from the survey of the number of women who are not getting the message, we cannot rely on the current system to work, because it is not working. As the hon. Member for Lancaster and Fleetwood (Cat Smith) said, 400 affected babies have been born since it was introduced. That cannot continue; the warnings must be mandatory, along with raising awareness among GPs, pharmacists, specialists, midwives and health visitors.

Secondly, people should have an annual discussion with their GP or another health professional. The Epilepsy Society has argued that that should happen, and it is very much consistent with the valproate toolkit, which highlights the need for regular review. There should be face-to-face discussion with a health professional before the prescription is renewed.

Thirdly, all women should have access to specialist units, wherever they live. We must end this haphazard, variable position around the country, and we must address fully the concerns raised by SUDEP Action. Professor Ridsdale, a consultant who has specialised in this area of policy, says:

“A useful outcome of this exercise would be that whoever prescribes Valproate agrees to identify and provide regular advice to women and girls at risk. Better still, that policy-makers and providers start exploring how ongoing structured self-management advice might be offered to everyone with epilepsy.”

That is surely the ambition we should set.

Fourthly, we should publish the prescribing rates for valproate for every CCG. The Government say they have a commitment to openness, and this would be a good demonstration of it, because we would be able to identify where the real problems exist and where women are not getting access to good enough advice.

Fifthly, we should ensure that only those women who absolutely have to take valproate do so during their child-bearing years, in accordance with the advice, and that we end what appears to be the significant over-prescribing of this medication for such women.

Sixthly—this comes back to some of the interventions that have been made, including by my hon. Friend the Member for Westmorland and Lonsdale (Tim Farron)—there must be a financial support package. In a way, that comes down to the Government’s duty to these people. This has gone on for many decades, so my point is not directed just at this Government, but they have the responsibility here and now to do right by these people. There is an overwhelming moral case for them to do that, and it is not good enough for Ministers to simply say that support is available locally through local authorities or CCGs. These families have suffered an injustice, and the Government have a moral obligation to address it. If it is right for thalidomide victims, it is right for those who have lost out severely as a result of valproate. In France, a €10 million initial fund has been established, and it could be increased. The Government need to take the same step in this country.

Seventhly, there must be a statement of regret or apology for the people who have been let down by the system so very badly.

Finally, there is a case for an inquiry or a Hillsborough-style panel so that we can understand how on earth this outrageous scandal could ever have happened, how it has gone on for so many decades, letting down so many families, and what lessons can be learned to ensure that this never, ever happens again.

Order. If colleagues could stick to around nine minutes, we will be able to get everybody in.

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.

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.

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.

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?

It was heartbreaking and infuriating to read the news that 68% of the women who are taking valproate today were not aware of the risks. That is a failure for all of us. We debated this issue in March 2013, and we have put down early-day motions. There was a television programme, chaired by Huw Edwards, in which the victims took part. We thought we had cracked it: we thought we had advertised enough so that no one, after 2013, could be in the position of not realising the terrible risks caused by taking valproate in pregnancy.

I am not making any criticism of anyone, except the MHRA, and we must look at our relationship with the regulatory body. The former Minister, the right hon. Member for North Norfolk (Norman Lamb), did all he could. He has a great and honourable record as a compassionate campaigner on many issues. It is a shock to all of us in that we did not expect there to be compensation, but it should now be coming along. It is not compensation in any serious way, but it is some admission that a terrible mistake has been made—not by the mothers, but by the system.

It is helpful to look back at what happened with thalidomide, which I remember vividly. There were 2,000 cases of birth defects in the United Kingdom; there were 20 in the United States. Why? The reason is that we went on prescribing Destobel for a year after the birth defects were suspected, because the drug company was adamant about it. It had tested the drug on animals, including pregnant animals—pregnant rabbits, even—and only when it went back to do another test of a particular strain of the drug on pregnant rabbits were the birth defects reproduced. That shows the limits of animal testing. The real difference was that the regulatory body in the United States would not accept thalidomide in that form, and its use produced a very small number of cases: 20 compared with 2,000.

We have had the effect of a drug called Vioxx for arthritis sufferers. According to the Food and Drug Administration in America, it caused 60,000 deaths; imagine it—60,000 deaths. How many bad reactions did the MHRA have in this country? About six. We would still be using it if the FDA had not discovered that death was one of the side effects of the drug, which was taken by millions.

GlaxoSmithKline in America has been fined—it is hard to believe—$3.5 billion. What was the fine for? It had suppressed the evidence of the trials it had carried out. It did not publish any of the negative results of the trials it carried out, and only the ones that were neutral or favourable. Drugs that were killing people were getting on to the market—this is a British company. What did the MHRA do in this country? Nothing! I wrote to them saying, “For goodness’ sake, you have to act against GlaxoSmithKline.” It is no coincidence that the person who chaired the regulatory body for more than a decade was a previous employee of that company. I am not saying that in this instance the body did absolutely nothing; it did produce the tools and provided advice, but that clearly did not work—how could it have done if 68% of the women still taking the drug did not know?

This issue applies to all Governments; it has been raised many times before. What we need is a regulatory body that is not paid for or controlled by the pharmaceutical industry but is independent and controlled nationally. Some years ago in Italy, the system changed. The pharmaceutical industry still pays for running the body, but for the past 20 years each Government have said that they would not have a fully independent body because they did not want to pay for it, although it was fine if the burden was taken by the pharmaceutical industry itself.

I do not want to say that we are all against the pharmaceutical industry, which has produced miraculous results this century. Valproate is a very good drug: everyone I have spoken to who has used it says that it is very effective and that it reduces seizures, epileptic fits and the incidence of bipolar disorders. We do not want to stop its use at all and we want to appreciate its quality, but after these four years, when the evidence from parents who have suffered has been there, clearly nothing has worked. We must look to reform our regulatory system, appreciating the value of the drug but at least setting up a fund that can express the sorrow of the country and the regret that we have not sorted this matter out or given warnings to future parents. We must make sure that the reforms suggested by the right hon. Member for North Norfolk proceed as a matter of great urgency.

Will the hon. Gentleman give way?

He has finished.

I thank the right hon. Member for North Norfolk (Norman Lamb) for securing this important debate and the Backbench Business Committee for allowing us time in the main Chamber to consider this issue. I also pay tribute to campaigners who have done so much to raise it.

As one who works closely with constituents so gravely affected by the use of Primodos as a pregnancy test, I recognise the huge importance of airing such concerns on behalf of our constituents as widely as possible so that all can hear. There is so much work to do on Primodos, and I hope to bring those concerns to the Prime Minister shortly. As the chair of the all-party parliamentary group on women in Parliament and a former member of the Women and Equalities Committee, I want to take the time today to note, along with colleagues, that many Backbench Business and Westminster Hall debates seem to focus on women’s health issues: Valproate, Primodos, vaginal mesh. It is great to see such an issue raised in the main Chamber.

I come back to the point I made earlier. We seem to see these themes. Rather than having multiple separate inquiries, should we consider issues such as Primodos and valproate together? Common learnings need to come out of them.

I absolutely agree. I hope to pull that issue together as I go on with my remarks. It is really important that we raise the case of sodium valproate, which, as we have heard, is still in use. All of these issues need to be looked at.

Common to this debate—and in all such cases, including Primodos—are the hidden, missing and lost documents, along with a delay in education and information. That was raised again today by the right hon. Member for North Norfolk. I pay tribute to Sky News for its exposés on valproate and Primodos, because this really matters to the families affected.

My hon. Friend raises a valid point about media coverage. I congratulate right hon. and hon. Members on raising the issue in the Chamber today, but I am concerned that it might make some women nervous about taking medication if they are pregnant, or are considering whether they would like to become pregnant and are on medication. Surely one of the messages we want to send out today is, “Please consult your doctor and do not respond to everything you read in the press if you are taking epilepsy medication.”

I thank my hon. Friend for her intervention. Many of us have constituents, friends or family who are affected by epilepsy, which, in itself, is very serious, or by bipolar disorder. Appropriate use remains very important. For the vast majority of patients, treatment can be effective and useful if it is done right—if managed, if educated and if understood. The argument, therefore, should not be about ceasing use, but about telling the truth and looking at appropriate use during pregnancy. Men use the drug too, so we need to take a balanced approach and reflect all situations.

The hon. Lady is making really good points. I totally agree with her that the drug is appropriate for most people. I just want the guidance to be followed. The guidance is clear that for women of childbearing age it should not be used unless there is no alternative. We just need to stick to that guidance and make sure it is implemented everywhere.

Absolutely. Speaking about this issue in this Chamber will empower our women constituents, before and during pregnancy, so they can be informed and make the right choices. That is the outcome we should all be hoping for.

Similar issues were raised yesterday during a debate in Westminster Hall on mesh implants. New mothers in particular had taken the advice they were given without hesitation. A woman’s first pregnancy can be an unsettling time with all the changes their body goes through. I would imagine that for people suffering from epilepsy or bipolar disorder that time is even more nerve wracking. It is absolutely right that we are measured when we talk about these issues.

It is important that our specialists ensure that women are given the correct and proper guidance. Patients need knowledge and they need it more than anyone. They live with the consequences if things go wrong and they will always look back on their decisions. If they have not been given the right information, how can they truly know they have made the right decision for themselves and their family? Siblings are often impacted as well.

The Government and MPs have a really important role to play in raising awareness of medical issues during pregnancy, including those concerning sodium valproate. I recognise the efforts that have been made, with labelling on packages. I am sure the Minister will agree, however, that more needs to be done. This drug, introduced in 1974, has been crucial, but support for families affected is also crucial. I welcome the fact that young people who have been affected are to be included in the new framework for health and social care for children and young people. It has been a real battle, but clinical commissioning groups and local authorities are getting to grips with it. It is really important that they receive support on a local level. I welcome the Minister’s forthcoming meeting with the all-party group, and I know that Ministers are taking this matter seriously, but I ask the Department for assurances on similar health issues affecting women, such as those relating to Primodos and mesh implants. We have moved to an incredible place on blood contamination—some of my constituents were affected by that—and constituents have written asking me to raise this issue too. We want more action, and there is a common denominator.

Two years ago, I asked the Minister to extend the Primodos inquiry to include valproate, but my request was declined because, I was told, the two issues were very different, yet they seem to be quite similar. Does the hon. Lady think that that was a missed opportunity?

As a woman in Parliament, I think that any opportunity not taken to raise women’s issues is a missed opportunity, and I know the Minister is listening intently.

The hon. Member for Newport West (Paul Flynn) raised a point about the seemingly cosy relationship the MHRA has with the drugs companies, when it suits it, and sometimes the laissez-faire attitude it adopts, when it suits it. It is incomprehensible that greater independence cannot be injected into this area. We need openness and reform. I would like the Minister to take a look at the position in France and consider setting aside some funding for compensation for medical accidents.

Few in the Chamber can imagine the hardship, guilt and heartbreak of the impact of taking a simple prescription drug during pregnancy and finding out later that it might have had an effect on one’s child. I am lucky to have two healthy beautiful daughters. We are all at the mercy of decisions we take during our pregnancy and the professional guidance we receive. We are fortunate to have the opportunity to raise awareness among people in this situation, but there are those not lucky enough to be sufficiently informed. This is an important debate, therefore, and I urge the Department to work with the MHRA to give patients full confidence in it on all pregnancy matters.

I am pleased that we are having this important debate, and I pay tribute to the right hon. Member for North Norfolk (Norman Lamb) for securing it and for setting out so clearly the issues involved.

My career before I was elected was as an NHS clinical scientist. Working in a biochemistry laboratory, I was very familiar with sodium valproate as part of the battery of anticonvulsant drugs for which we regularly tested patients to help their clinicians better monitor their treatment and ensure that their dosage was at the optimum level. Until I met Emma Murphy, however, and became aware of her campaign, I was not aware of what appeared to be a systematic failure to inform women of the potentially damaging effects of taking valproate during pregnancy.

Only after watching a television programme about foetal anticonvulsant syndrome did Emma herself became aware that her own children’s health problems were probably attributable to the anti-epileptic drugs she had taken while pregnant, which had been prescribed to her from the age of 12. Like everyone in the House, I pay tribute to Emma Murphy and Janet Williams for their great campaigning work.

The damage to the developing foetus is thought to be caused in the first trimester of pregnancy when the anti-epileptic drug crosses the placenta into the foetus, and the effects depend upon the dosage and the drug. Sodium valproate, or Epilim, is indicated in 80% of cases of foetal anticonvulsant syndrome. Experts such as Dr Peter Turnpenny, clinical geneticist at the Royal Devon and Exeter Hospital, say that Epilim may affect about 560 babies every year. He adds:

“About 10% of foetuses exposed to sodium valproate will have a major congenital malformation such as cleft palate. 12% are likely to be diagnosed with a neurodevelopmental disorder.”

Reports linking valproate to birth defects started to appear, most notably, in 1981, with a paper by H. Nau entitled “Valproic Acid and its Metabolites”. In 1983, the British Medical Journal published an article in which the Royal Liverpool Hospital cited two cases suggesting a link between birth defects and valproate taken during pregnancy. The American Journal of Medical Genetics cited seven cases in 1984 of children born with malformations to mothers taking valproate, and the Journal of Paediatrics cited 26 cases in 1986. The list goes on. It would appear that the evidence was steadily building up with the publication of more and more cases linking valproate to birth defects. The Committee on Safety of Medicines and the Medicines and Healthcare Products Regulatory Agency noted those reports, and, I hope, monitored the use of valproate, particularly during pregnancy.

We have heard about various scandals. In the case of Vioxx, which was mentioned by the hon. Member for Newport West (Paul Flynn), trials did not show a problem but real-world use did. Does the hon. Lady think that we need some kind of reform of the reporting system? There is something that we call a yellow card, and patients can now fill it in themselves, but many of them do not realise that. I feel that there is not enough “flagging up” when patients suspect that they are suffering from side-effects.

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?

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

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.

The hon. Lady is making an incredibly valuable contribution to the debate. Does she agree that if it is clear during a period of time that the amount of a drug that is being prescribed is significantly more than the guidance suggests is appropriate, it is not acceptable for the drug company, the regulator and the Government simply to be passive and to allow that to continue? If we knew that this drug was being over-prescribed, which appears to be the case, why on earth was action not taken?

That is a very good point, and if we manage to establish an inquiry, it should look into the issue of over-prescribing.

I want to mention other agencies. The European Medicines Agency has also recommended a strengthening of measures to reduce the risk of harm to babies born to mothers taking valproate. Information from the House of Commons Library outlines a situation in France, which has already been referred to, with an estimate that between 425 and 450 children were affected by birth defects attributable to valproate from 2006 to 2014. The French Parliament this year voted to set aside €10 million for claims related to valproate. The Health Minister, Marisol Touraine, described this as a “starting point” and stated that compensation would ultimately be paid by those deemed responsible:

“I regret that Sanofi didn’t seek an amicable settlement as a matter of principle. I hope Sanofi will change its position.”

Sanofi had no comment to make on the Minister’s remark. A class action has also been brought by the French association for people affected by sodium valproate against Sanofi.

In the UK, in 2004 a class action was brought by a group of families under the Consumer Protection Act 1987, which was expected to go to trial in 2011, but the litigation was discontinued prior to this after the Legal Services Commission withdrew funding. It is disappointing that this Government have said that there are no current plans to introduce a compensation fund similar to that in France, and I urge them to reconsider.

I fully support the remedial steps outlined in the motion, including the call for an inquiry, and this Government must bring forward a care plan and financial assistance for the victims of this national scandal.

I congratulate the right hon. Member for North Norfolk (Norman Lamb) on securing this important debate, which I hope will compel change. I also join colleagues in putting on record my thanks and admiration for the FACS Association founders, Emma Murphy and Janet Williams, who are here today. Emma and Janet are an inspirational pair who have turned their life-affecting experiences as victims of this syndrome, and their knowledge of victims of it, towards justice on the issue and the demand for better knowledge of the risks that sodium valproate poses to our unborn children.

I speak as someone who for 10 years or so took sodium valproate, not in utero, but in childhood. At seven years of age, I was rushed to hospital with meningitis. Within a few hours, I was fighting for my life and in a coma for two days before responding to a spinal tap. I was one of the fortunate ones and survived without any of the known side-effects such as deafness, blindness or amputation, which routinely follow for those suffering from meningitis. Instead, I was left with epilepsy for the six years that followed. During that time, I got pretty close to the NHS, its out-patients and out-patient wards, and its brilliant teams of nurses and doctors, who worked together to get me better. I was prescribed sodium valproate, and dutifully took Epilim for at least six years, so I stand here also to give voice to epilepsy sufferers in this country.

Let me give the House a sense of what it is like to endure a convulsion. There is a stillness at the control centre of the mind, but a violent movement of the body—an arm, the head or legs. You are aware of it but unable to prevent or stop it. I recall that it is possible to steer it, though I do not know how. I remember, as a young boy, enjoying, like most siblings, bunking down in a bedroom with a sibling and being able, on the rare occasions I had convulsions—only between 4 am and 6 am —to wake my sister, with whom I had enjoyed a sleepover in one of our bedrooms. She alerted my parents and I was observed until the convulsion stopped because there is nothing that can be done.

Epilim—sodium valproate’s commercial name—is widely thought to be the greatest contributing factor to curing me of epilepsy. But for a simple twist of fate, I might have consumed the drug at a different time. When Emma and Janet presented me with the National Archives papers of minutes from 1973 and 1974, when decisions were taken to withhold the knowledge of the risk to foetal development, I was stunned. There were notes in those minutes advising two consecutive, different Governments not to include any warning or information on the risk. It is all too familiar: another national cover-up and further scandal from those closed decades; the “we know what’s best for you” attitude taken by the few to the many, and often said by men to women; the long wait for social justice, and a burning injustice finally coming to light. There was conspiring against the women for whom the drug was prescribed.

I want to spread not fear, but knowledge of sodium valproate. I stand here as a record of its effectiveness, but I also stand up for the unborn children, the women and the expectant parents to whom the risks are not widely enough known. I welcome the news that warnings will feature on the outside of packaging and hope that our medical leaders and the Government will appreciate that issuing guidance is not the same as ensuring knowledge.

I support practical steps such as the distribution of the valproate toolkit to all clinicians, pharmacists and women for whom the drug is prescribed. The Government have a duty to respond with practical steps to address the problem. However, our fight is as much against the cover-up as it is for the clear picture we need to send to parents where mum is taking valproate.

Let this be another moment where we draw caution for all those in positions of power who are about to make decisions that keep people in the dark, or withhold information that is life-affecting, life-changing or poses risk to life. Life will catch up with you. The truth will out. An open and tolerant society has freedom and equality of access to information as a guiding principle to life in it.

On health, decisions should not be made for us, but taken with us: nothing about us without us; a democratic voice at the table; an informed patient choice, not deals in the dark. We have a democratic deficit in decision making on health matters and services. Sadly, on the evidence of last night, there is a democratic deficit on the part of the Government, too. They say they are a listening Government, but I think we have a Government who refuse to hear.

I urge the Government to listen, to make amends for this national scandal, to look at compensation, to address the lack of knowledge, to apologise to the women and to the children who are now men and women themselves, and to make clear our instruction that no content or information pertaining to health and medical prescriptions and the decisions for patients to make should ever be withheld again.

It is always a privilege to speak in these debates. I give special mention to the hon. Member for Bury North (James Frith), whose powerful and personal summary of his life has greatly added to the debate. Everyone who heard his contribution will appreciate it and thank him for it. The right hon. Member for North Norfolk (Norman Lamb) set the scene so capably, outlining the case for addressing valproate and foetal anticonvulsant syndrome. I pay tribute to him for the summary at the end of his speech, about which I will speak later, and his eight recommendations. If there are any recommendations to follow, those are they, as everyone in the House will agree. I thank all the other hon. and right hon. Members who have spoken, because their contributions were equally as important, and I also thank those who made interventions. The House shines better whenever we discuss issues on which we can have an input both personally and on behalf of our constituents, and this is one such issue.

There is no greater gift from God than a little baby. I have two wee granddaughters, and I adore them. We maybe do not spend as much time with them and our children as we should, but we try. They are both perfect in my opinion, even if they have some tantrums. As girls, perhaps they have different tantrums to boys—I only had boys, so I do not know. We live on coffee in my office—I suspect everyone else is the same—and I have watched my parliamentary aide as she refused her normal 10 cups of coffee and drank only caffeine-free beverages for nine months during her pregnancies. Indeed, her not drinking coffee was the first indication that she was expecting again. She had had two miscarriages but now had one baby and was expecting her second, so she was going to take every step that she could to ensure that the baby was perfect. She said that the reason for not drinking caffeine was that it can make the baby’s heart beat a little fast. Mothers everywhere will do almost anything to ensure that they protect that little life when they know of its existence. Unfortunately, as this debate has clearly shown, some mothers did not know what was happening, which is why I feel strongly that more research must be done for the mothers who have long-term health problems and do not know how the medication they need may affect their children. Every Member who has spoken has made that point.

I want to throw another point into the equation. People with ulcerative colitis, Crohn’s disease and other conditions who have infusions such as infliximab have to come off them if they want to get pregnant. Some people are made aware of such things, but does everyone know that? I suspect not, but they should. The hon. Member for Central Ayrshire (Dr Whitford) and others referred to the yellow card scheme, and people need to be made aware of when incidents happen. More needs to be done to ease families’ minds, and that is why I join with colleagues today to ask for more to be done not only in the case of this epilepsy medication, but with more long-term medications in general. We must look beyond this debate and encapsulate what other people are saying.

Sodium valproate is an anti-epileptic drug that is associated with greater risks in pregnancy than other AEDs. Other valproate medicines include valproic acid and valproate semisodium. The Medicines and Healthcare Products Regulatory Agency reports that, although the general risk of foetal abnormality is 2% to 3%, the risk for women taking sodium valproate is around 10%. Did those women know? This debate illustrates that they did not, but they should have known. We have to address the issue now.

The birth defects can include spina bifida and limb, facial and skull malformations. The use of sodium valproate in pregnancy can also affect a child’s development. Many Members, including the hon. Member for Bury North in his powerful speech, have told us exactly what valproate does. Children have delays in learning to walk and talk. The drug can lower intelligence, and affected children have poor speech and language skills compared with children of the same age.

There have unfortunately been many scandals over the years, and my constituents made me aware of the thalidomide scandal, to which I can relate. The hon. Member for Eastleigh (Mims Davies), like me, spoke in yesterday’s Westminster Hall debate on mesh implants: I have been contacted by many affected women, and they did not know what the risks were, either. They have lived with the repercussions for years. One Member mentioned a lady who had to go in three times in six years to have operations before she was cured.

The same is true of Primodos. A Member who is not here told me about his involvement with that issue. There many such scandals and, as other Members have said, we need to bring them all together under one headline.

I am not a doctor, and I have no medical skills, but I can read about symptoms. I have no medical training, but it appears that the risks are significant enough that people should be fully informed of them before they are prescribed such medication. The massive risks in taking these drugs during pregnancy will then be embedded in their minds.

Many of us were supplied with the Epilepsy Action briefing. The statistics are hard to read, but they are very clear. I also thank the Library for the in-depth information it has provided so we can prepare for this debate. The surveys to which hon. Members have referred go back to 1995-96, when a possible problem was first mooted, but no action was taken. The Library briefing says:

“This survey has been repeated in 2017, when it was found that 18% of women taking the epilepsy medicine sodium valproate didn’t know the risks this medicine can pose during pregnancy and 28% of women said that they had not been informed of the risks of this medicine in pregnancy.”

How can it be that lessons have not been learned?

Dr Rhys Thomas, an honorary consultant in epilepsy at the Royal Victoria Infirmary, Newcastle, says:

“This is a dramatic and important survey focusing on a crucial area for women with epilepsy. As a medical community, we clearly could be doing more, and should be doing more. Even if women are being told of the risks, this may be at the wrong time for them—or in the wrong way.”

Sometimes the risks are not explained in a way that people understand, which is wrong. We need to have the conversation, and it has to be repeated. People need to be aware of the risks, and I am not sure that that has happened in the way it should.

The Medicines and Healthcare Products Regulatory Agency figures suggest that up to four in 10 babies are at risk of developing disorders if valproate medicine is taken during pregnancy—that is massive. How can it be ignored? Approximately one in 10 babies is at risk of physical birth defects. Babies affected by sodium valproate can have severe problems that require lifelong care and support. Are we looking at prevention? Are we looking to the future? Are we looking at what the long-term care will be? I suspect not.

It is estimated that 20,000 babies have been affected and 400 babies a year are born to women taking sodium valproate. Epilepsy Action, the Epilepsy Society and Young Epilepsy have surveyed more than 2,000 women with epilepsy, and they found that some women are still not aware of the risks of taking epilepsy medicine in pregnancy. More than a quarter, 28%, of women who have taken an epilepsy drug have not been given information. That would indicate to me that a knowledgeable medical professional should have taken the time to go through the risks of being pregnant with people on the drug. After someone has become pregnant, it may well be too late, so those discussions with the GP are very important. It is not a matter of someone simply stopping a drug when their pregnancy test is positive, as that is not the safe way to do things.

In conclusion, I urge that the eight points are followed, but that we should put in place the compensation fund that everyone in this House wants to see, because that will at least help the families affected to deal with the financial positions they are in.

I call Cat Smith. If she could finish at half past, I would be grateful. In addition, if the wind-ups could be about nine and a half minutes long, that would allow us to bring in Norman Lamb.

Thank you, Mr Deputy Speaker. It is a pleasure to be able to be squeezed into the end of this debate, and I shall be brief. For me, this debate started within days of being elected as an MP in 2015, when my constituent Janet Williams got in touch to ask whether she could meet me. When I was first elected, I imagined that I would meet most of my constituents back up in Lancashire, but Janet was keen to get a meeting in quickly and she chased me down to Westminster. I met her in Portcullis House, along with Emma Murphy. Both of them have been mentioned a lot in this debate, and I pay tribute to the work they do on this important issue.

When I met Janet, my jaw hit the floor, as I could not believe that in this day and age women were still being prescribed drugs that were harming their unborn babies and they were not being told about it. But it was not just that they were not being told about it; a cover-up was taking place. I find this to be a national scandal, and I do not use those words lightly. I have met Janet’s sons, Philip and Lee—they are both constituents—and for them this is a life sentence. Janet should not feel guilty for taking the drugs that her doctors told her to take during her pregnancies, but her sons will continue to need care throughout their lives; they are young men in their 20s and so that is a huge social care need.

This scandal started in the 1970s but, as I have said, it continues today, with women in this country still being prescribed this drug. It is a great drug—it is a very effective anti-epileptic-fit drug and it is good at treating bipolar conditions and migraines—but we need women to have knowledge about it. We need to share knowledge with women so that they can make decisions about their own bodies and own health in pregnancy. So I urge the Minister to respond to the call to publish prescribing data so that we know whether certain areas of the country are overprescribing this drug to women of childbearing age, as colleagues have mentioned. I also add my voice to the call for a public inquiry into this national scandal, and for an adequate compensation package for all those many people and their families who are affected by this national scandal.

I, too, pay tribute to the right hon. Member for North Norfolk (Norman Lamb) for securing this debate and trying to air this issue again. Epilepsy affects 1% of the population—600,000 people—and it is not a trivial condition. It is dangerous. As we have heard, 1,200 people a year die due to epilepsy, and we must not diminish that fact. At the lowest level, someone who has a fit after being well controlled suddenly cannot drive again, which can have quite a big impact, but at the other end of it there is death. We therefore must be careful not to send out a message that anti-epileptic drugs are bad, or even that Epilim is. It works really well, and it is one of the drugs that often can control the most dangerous seizure—the tonic-clonic or grand mal, as it used to be called—without the use of other drugs.

Almost all anti-epileptic drugs carry risk. Sodium valproate is the worst by far, but all the ones we have heard of in the past—phenytoin, phenobarbital, primidone and carbamazepine—carry some risk. We therefore have to recognise that it is not just as though the doctors prescribed the wrong drug. This condition is really hard to deal with, and we need people to have specialist input. We are really asking that from when girls reach puberty until they reach menopause or get into their 50s—when there is no risk of them having children—decisions are made with them by specialists.

As we have heard, there was obviously a recognition right back in the ’70s that sodium valproate could bring about congenital abnormalities, but what appears to have changed is the scale. If we look back, we see that people used to discuss a 2% risk of malformation and “some possibility” of developmental delay. We are now talking about 10% of children having a birth defect, which might be something like a minor cleft palate that can be dealt with, right through to spina bifida, meaning the child faces major physical disability. On a much worse scale, some 40%—almost half—of children face some form of developmental delay, which might mean an autistic spectrum disorder, learning difficulty or ADHD. That is a big change.

We heard earlier about the 1995 paper that started to bring these cases together. Before that, there were predominantly case reports—someone saying, “Oh, this is odd; I’ll write it up”—but we needed someone to bring things together. When we hear that 400 affected babies have been born in the year since the recent attempt to deal with this issue, we realise that had the yellow-card reporting system been working when we had perhaps 500, 600 or 700 cases a year, the situation would have been spotted much more quickly.

The system utterly failed to recognise a pattern and has to be reformed. If a woman gives birth to a child with a birth defect, or there is in the very early years recognition of some kind of major developmental delay, and she is on a drug, that should be reported, and I do not care what the drug is. Her GP may never have seen such a thing before and might not recognise that there could be an association, but someone sitting in the MHRA who is receiving 400 or 500 reports certainly ought to.

The obvious question is how to tackle this issue. The toolkit was put out in February 2016, because we have recently recognised the huge scale of the problem—the change is the recognition of the scale. It is therefore shocking and incredibly disappointing to hear that more than two thirds of women have not received any part of it. It is great that there is now some marking on packaging, but perhaps more of that needs to be combined, because we then do not have to depend on people remembering to hand something out or to pick something up. We would be empowering women to say, “Oh, what’s that? You’ve never talked to me about that,” and both sides would have the chance to have a discussion.

We have predominantly focused on the results of using sodium valproate during pregnancy but, as the hon. Member for—

Strangford.

Sorry. I am not doing very well today. Six hundred and fifty names is hard enough; adding another 650 constituencies just does my head in!

As the hon. Member for Strangford (Jim Shannon) mentioned, by the time a women is pregnant—crucially, by the time she knows she is pregnant—it is too late, because these abnormalities happen in the first trimester: those first two months when the brain and spinal cord are forming and the arches of the face are combining. That is why we particularly see neural tube defects, brain function abnormalities and cleft palate. Many women who lead hectic lives may already be two months pregnant by the time they finally know, and that means it is too late. That is why the annual review is important.

Epilim is perfectly fine for a girl to use if it gives good control for grand mal seizures, but we need to flag up the fact that when she is expected to be approaching puberty, discussions need to start with her and her family. Family planning is important for all women, but for women on these kinds of drugs, which must be stopped in pregnancy, it is crucial. We need to have that discussion so that the alternatives can be considered. I echo the comment that if a woman is pregnant and did not plan for that, she should not stop the drug on her own. She should have emergency access to a specialist who is able to look at her type of epilepsy and discuss the options with her, such as whether it would be safe to take nothing or if it would be better to change to something else. It should be recognised that uncontrolled seizures in pregnancy can cause the loss of the mother and the baby. We must not have any kind of irresponsibility by not flagging that up.

We had a debate in this Chamber last week on baby loss. It was a very powerful cross-party debate on the anguish that people face, whether it is due to early miscarriage, stillbirth or neonatal loss. We talked about that loss and bereavement, but any of us—male and female—who have had children know of the expectation and joy that comes from waiting for a child. There is still exactly that bereavement when we know that our child will face a life of physical and mental difficulties, and of learning disabilities. We know that a child with a marked learning disability has only a 7% chance of working. For the parents, there is the stress of knowing that there will come a point when they are not there, and of wondering how their child—perhaps now a young adult—will actually survive facing a harsh world.

Financial support is absolutely crucial to give families peace of mind. We need an inquiry, but rather than holding multiple inquiries, we should recognise that bringing some of these common themes together into one would be a much more powerful way to get people to understand that we are talking about relentlessly repeating patterns. Let us try to reform the things that allowed this to happen and to ensure that we support the families and the children to whom, sadly, it has happened.

It really is an honour to be responding for the second time in this Chamber today on behalf of the Opposition.

First, I thank the right hon. Member for North Norfolk (Norman Lamb) for securing this very important debate. It really was much needed so that we could finally discuss in detail, and in the main Chamber, the issues around valproate and what the Government must do to address this injustice. He spoke with passion and obvious outrage on behalf of the thousands of women and children affected by this disgraceful scandal.

I, too, want to thank other hon. Members who have taken part in this debate, including the hon. Members for Congleton (Fiona Bruce) and for Eastleigh (Mims Davies), and my hon. Friends the Members for Newport West (Paul Flynn) and for Heywood and Middleton (Liz McInnes). My hon. Friend the Member for Bury North (James Frith) gave an extremely moving account of how the drug helped him as a young boy, making the point that, when used correctly, it can be a very good drug. We also heard contributions from the hon. Member for Strangford (Jim Shannon), my hon. Friend the Member for Lancaster and Fleetwood (Cat Smith) and the hon. Member for Central Ayrshire (Dr Whitford) who speaks for the Scottish National party. It has been a very good debate.

As we have heard, the issues of valproate and its effects on foetuses are not new. In fact, they span a significant number of years, going as far back as the 1970s and 1980s when the first cases of the effects of valproate were documented. Even recent scientific research has shown that valproate can have an impact on a child’s life, including a study finding that 10% of children exposed to valproate will be born with a major congenital malformation, with 29% requiring additional educational support and 6% being diagnosed with significant social communication difficulties, such as autism.

Although there has been some movement on making women aware of the risks of valproate during pregnancy through the valproate toolkit, there is still far more that should and must be done to support these women and their children who have been so seriously affected by this injustice. The scope of this issue is serious. Data from 2010 show that more than 21,500 women were prescribed valproate. Although not all those women will have become pregnant, or planned to become pregnant, it is worrying that, following the toolkit’s publication, there is still not enough awareness of the risks, with 85% of patients not receiving the booklet and 90% not receiving the pharmacist’s card. It is important that the Minister looks into this matter urgently and ensures that awareness is increased to help to address the lack of knowledge. That could save so many innocent lives from being irreparably damaged.

As part of that, will the Minister be minded to agree that the NHS should make it mandatory for every clinician prescribing sodium valproate to a woman or girl of childbearing age to have a conversation with her about risks during pregnancy, upon first prescribing the drug and at least yearly, before her prescription is renewed?

Over the decades there have been countless opportunities for this drug to be investigated, especially when evidence from the 1980s grew. Yet the various regulatory bodies for medicines have failed to keep their eyes on it as an issue worthy of investigation, with only fleeting references in position papers and reports, and nothing substantial. This is why it is welcome that the European Medicines Agency, in one of its first public inquiries, on 26 September 2017 called together patients, carers, doctors, pharmacists and academics to look into the matter further. It will be interesting to see the outcomes of its investigation when it concludes.

We have a duty to set the mistakes or oversights of previous Governments right, which is why we are here today—to seek justice for the victims of sodium valproate in pregnancy and their families. The Opposition welcome calls for the Government to look into how they can compensate the families who have been so significantly affected.

It must be noted that, as others have said, the drug is an effective treatment. For many it may be the only drug that works for them. Nevertheless, there is a systematic failure to inform women of the dangers of taking valproate. If expectant mothers had had the risks laid out clearly for them, many children would not have been harmed, and I hazard a guess that we would not be debating this issue today.

For those reasons Labour promised, in our election manifesto earlier this year, that we would look into this further by holding a public inquiry if we won the general election. We now make a plea to the Government. The evidence collected by In-FACT shows that despite the Government, pharmaceutical companies and regulatory bodies knowing about the risks for 40 years, that knowledge was withheld from women, which meant they were unable to make informed decisions about their drug treatment during pregnancy. I must ask the Minister: why have we not got to the bottom of this injustice, and is it not about time that we did?

A lot of the issues that we must understand and investigate are historic, yet for some they are still very prominent in their present. Many families are living with the repercussions of not being given the relevant information.

Hon. Members may have watched “Victoria Derbyshire” in recent months, on which valproate has been discussed, including last month when Deborah Mann, who took valproate during her pregnancy, discussed how the drug had affected her daughter, Branwen. Deborah had been given a dose of valproate of 5,000 mg, five times higher than the recommended daily dose of 1,000 mg. Any dose above 1,000 mg is considered to have the largest level of risk. Branwen has had to wear splints every day since she was a little girl. She is in chronic pain every day. She has migraines and problems with her brain and eyes. At just 22, Branwen has been told that she could go blind, have a stroke or even die at any moment.

I recently met the inspirational Janet Williams and Emma Murphy, who a number of hon. Members on both sides of the House have paid tribute to. I now realise that they are in the Public Gallery. They set up In-FACT in November 2012 after two of Janet’s children and five of Emma’s children were diagnosed with foetal anticonvulsant syndrome. We heard in detail from the hon. Member for Congleton the extent of the appalling damage to Emma and Janet’s precious children, and all of it was preventable. Both Janet and Emma campaign tirelessly after being told—in the case of Emma, time after time after time—that these drugs were safe to take in pregnancy. These women did ask the obvious questions when the truth was already well known, and they were still told that these drugs were safe to take while they were pregnant. Can hon. Members imagine how that feels? As a mum, I would be absolutely furious—we all would. I would want answers. I would want justice, and so do Janet and Emma.

It is approximated that, since 1973, 7,000 children have been harmed by exposure to valproate. No doubt there will be many other families who have failed to conceive or who have had stillbirths or miscarriages—all because of this drug. That is why we must get answers, but it is also why we must look at what compensation we can give these families because of the failure of the NHS to protect and support them. The idea of compensation has been established by our neighbours across the channel, where the French Parliament has recognised the true scale of this injustice and established a fund worth €10 million to support the victims of valproate and their families.

Opposition Members believe that mistakes should be recognised, addressed and accordingly compensated for. We also believe that burying our heads in the sand and ignoring the demands of the victims goes against the nature of justice and righting the many wrongs of the past. These families must be supported and allowed to have a full investigation into the failures and damage they have had inflicted on them.

The Minister cannot ignore the scale of this tragedy and the numbers of people who have had their lives so adversely affected not through any fault of their own, but due to medication they were prescribed by the NHS. We are here today to ensure that the Government wake up to the enormity of this scandal and take immediate action.

More must be done to make women aware of the risks of taking valproate during pregnancy, and to ensure that the injustice that has gone on for far too long is righted, with answers found and support provided to these families, who have seen their lives turned upside down because of what can only be described as a cover-up. The Minister should and must listen to what has been said today. I hope he will assure the House that he has constructively listened and that he will start the process of righting this pernicious wrong by holding a full public inquiry and properly supporting these families. They need, want and deserve justice. They should, at long last, receive nothing less.

I congratulate the right hon. Member for North Norfolk (Norman Lamb) on securing this debate through the good offices of the Backbench Business Committee. He has, as he indicated, taken a particular interest in this issue since it was brought to his attention during his time as a Minister in the Department of Health, and all tribute to him for being so persistent in that endeavour.

This is a very important issue. Members on both sides of the House have come together once again—for two weeks in a row, as the hon. Member for Central Ayrshire (Dr Whitford) pointed out—to demonstrate their concerns. Those are not party political; these issues affect all our constituents, irrespective of any party political alliance.

We have had some very constructive suggestions on both sides of the House, and we have heard a number of the personal cases that constituents have brought to the attention of Members, which has been very moving. Rather than rehearse them, I will just point to my hon. Friend the Member for Congleton (Fiona Bruce), who went into some detail, as the hon. Member for Washington and Sunderland West (Mrs Hodgson) said, about the particular circumstances of the two outstanding campaigners—I am pleased they are here to witness this debate—who have spoken so powerfully about the effects that valproate has had on their lives and those of their children. Like other hon. Members, I have very great sympathy for those families who have been affected by valproate use in pregnancy.

The Association of British Neurologists advises that valproate remains the most effective treatment for generalised epilepsy, and this is reflected in NICE guidelines. For some women with epilepsy, it may be the only effective treatment—the only thing that prevents a potentially life-threatening seizure. However, because of its risks, valproate should be used to treat women of child-bearing age only if other drugs are ineffective or not tolerated. This is not a clear case of use or no use, as was clearly pointed out by the hon. Member for Central Ayrshire, who speaks with authority on these matters.

The key challenge for clinicians is to ensure that the drug is used only by those who really need it, that they are fully informed about the risks and that their treatment is closely monitored.

Does the Minister share my aspiration that we should be aiming to ensure that every woman, wherever they live, has access to a specialist unit?

I will come on to how access—and monitoring—needs to be improved.

As my hon. Friend the Member for Eastleigh (Mims Davies) acknowledged, it is vital that no woman stops taking valproate, or any other anti-epileptic, without first discussing it with their doctor and, if necessary, with the relevant specialist. The Medicines and Healthcare Products Regulatory Agency is currently working with European regulators, and with experts and healthcare bodies, to decide what further action should be taken. Like many anti-epileptics, valproate has always been known to carry a risk if taken during pregnancy. However, as hon. Members have pointed out, important questions have been raised, here in the Chamber and elsewhere, about the extent to which women have been informed over the decades about the risks.

At the time that valproate was first marketed in 1974 for the treatment of epilepsy, animal studies had shown that there might be a risk of birth defects. Health professionals were made aware of this and were expected to weigh the benefits against the risks. Difficult prescribing decisions had to be made. Campaigners have highlighted, as did the right hon. Member for North Norfolk in his opening remarks, the minutes of a meeting of the Committee on Safety of Medicines in 1973 where the Committee concluded that it would be best not to mention the risk of birth defects in package inserts. As has been said today, this paternalistic attitude has no place in the NHS of today. Now, patients and doctors are expected to make decisions based on open communication on the risks and benefits of a treatment, which is underpinned by legislation. However, that was not always the case, and the views expressed by the CSM in 1973 were not unusual at that time, particularly in relation to life-saving medicines such as anti-epileptics.

I am pleased to say that medical practice has changed considerably since then. Comprehensive patient information leaflets have been a legal requirement since 1999, and warnings have been issued when new evidence on risks has become available. The MHRA issued bulletins in 1983 and 1993 to update prescribers on the risk of birth defects, and in 2003 warned about a possible risk of developmental delay in children exposed to valproate during pregnancy. Warnings were extended to include a risk of autism in 2010, and a reminder bulletin was issued in 2013. Information on the full magnitude and nature of the risks with valproate first became available in 2013, following a long term follow-up of children whose mothers had taken valproate and other anti-epileptics.

Given those concerns, the MHRA initiated and led a Europe-wide review which completed in November 2014. The review found that there was still a clinical need for valproate despite the significant risks to the child if taken in pregnancy, and that it should remain an option for women of childbearing potential only where other treatments had failed or were not tolerated. To mitigate the risks, the recommendation was that women should use effective contraception and treatment should be supervised by a specialist. In January 2015, the MHRA sent a letter to doctors and pharmacists about the strengthened restrictions. As well as updating statutory information, the MHRA has developed the valproate toolkit referred to by hon. Members.

Although I am not allowed, quite properly, to use props while I am at the Dispatch Box, I cannot resist pointing out to hon. Members that the warnings now on valproate packaging include the following very specific warning:

“Warning for women and girls: This medicine can seriously harm an unborn baby. Always use effective contraception during treatment. If you are thinking of becoming pregnant or you become pregnant, talk to your doctor straight away.”

In addition to that warning on the packaging, there are other elements in the toolkit. I will not trouble the House to read them out, but they include patient cards, information for patients, and information for prescribers and clinicians. The toolkit was distributed to doctors and pharmacists in February 2016. Messages sent through different channels then and subsequently have reinforced the recommendation of its use to support discussions with patients.

In view of the importance of the issue, in the autumn of 2015 the former Minister for Life Sciences brought together healthcare bodies to support the promotion of the toolkit and ensure that there was co-ordinated messaging to health professionals and patients. The MHRA further developed that group into a 39-strong stakeholder network of health system organisations, health professional bodies, charities and campaign groups, which include In-FACT, FACS-Aware, the Organisation for Anti-Convulsant Syndrome, Epilepsy Action, the Epilepsy Society, the Royal College of General Practitioners and the Royal Pharmaceutical Society.

Our communications strategy has been informed at every step by the valproate stakeholder network, including NHS England. In response to concerns about gaps in awareness that have been identified by several Members in today’s debate, in July of this year the toolkit was redistributed to GPs and specialist prescribers, and additional materials were distributed to pharmacies. More than 100,000 healthcare professionals received the toolkit this year.

What are we doing beyond that? We are tracking changes in prescribing. Data show that between 2012 and 2017, there has been a decline of approximately 26% in the number of women of childbearing age treated with valproate. The decline is sharper among 10 to 17-year-olds. Although usage is declining, there has not been the step change that we would want, and, as has been mentioned today, the results of surveys of patient awareness of the risk clearly indicate that more needs to be done.

I am aware that campaigners have called for the use of the toolkit to be made mandatory. The MHRA and NHS Improvement sent out a patient safety alert in April 2017, which directs organisations systematically to identify women and girls taking valproate and to support them to make informed choices. MHRA and NHS Improvement are monitoring the implementation of the alert and are following up directly with relevant organisations. That action has been taken consistently across the UK and through the devolved Administrations.

The MHRA is fully involved in the new Europe-wide review to look into whether further restrictions are needed. An expert working group of the Commission on Human Medicines, a committee of the MHRA, has been convened to inform the UK’s position during the EU review, which is expected to conclude early in the new year. This review is also looking carefully at whether there is any evidence of adverse effects in babies whose father took valproate. I am sure the whole House was moved by the personal testimony of the hon. Member for Bury North (James Frith) about the consequences of childhood meningitis and his six years on valproate to control epilepsy.

I hope I have made it clear that we are taking the matter seriously. I have enormous sympathy for those families who have been affected by valproate use in pregnancy. In the short time that I have available, I want to touch on a couple of the issues raised by the right hon. Member for North Norfolk. He talked about support, and we have an established system, reinforced by the Children and Families Act 2014, to establish a new framework for local authorities and CCGs to secure services for children and young people who have special educational needs or disabilities.

I will not get into the question of compensation or an inquiry here. What I will say to the right hon. Gentleman is that a meeting has been arranged for the chair of the all-party group with my Lords colleague the Under-Secretary of State for Health, and the issues that the right hon. Gentleman has raised should be brought up at that meeting. I encourage other members of the all-party group to join him in that meeting at the Department.

I will look at the feasibility of extending the yellow card system, as hon. Members have described. I think it is right that we shine the spotlight of transparency to improve patient safety. No Government have done more than we have to make that happen in other areas, and the victims of valproate deserve nothing less.

I sincerely thank all right hon. and right hon. Members for participating in today’s incredibly well-informed, responsible and powerful debate. This is a fight for justice. The Minister is right that we have a meeting planned for 7 December with his colleague the noble Lord O’Shaughnessy, and I hope very much that by then, the Government will have reached a view on the case for compensation. The Government have a choice: they can either deny the unanswerable moral case for treating these people properly, or they can take the moral lead and accept that the state has a responsibility to these families. I hope very much that they do the latter.

Question put and agreed to.

Resolved,

That this House notes with concern that there has been a systematic failure to inform women of the dangers of taking the epilepsy drug sodium valproate during pregnancy, resulting in thousands of children being born with congenital malformations, disabilities and developmental disorders since the 1970s as a result of fetal exposure to the drug; welcomes the launch of the Valproate Toolkit by the Medicines and Healthcare Products Regulatory Agency in February 2016 to ensure that women are informed of the potential risks of the drug, but further notes with concern a recent survey which found that 68 per cent of women have still not received these safety warnings; calls on the Government to take immediate steps to ensure that the materials in the Valproate Toolkit are distributed to all prescribing clinicians, pharmacists, and women who are being prescribed the drug; calls on the Government to require all clinicians prescribing sodium valproate to women and girls of childbearing age to discuss annually with the patient, the risks during pregnancy before a prescription is renewed; and further calls on the Government to bring forward proposals for a care plan and financial assistance to the victims of sodium valproate in pregnancy and their families.