Fetal Anti-convulsant Syndrome: 26th March 2013

The Parliamentary Under-Secretary of State for Health (Anna Soubry)
It is, as ever, a pleasure to serve under your chairmanship, Mr Hollobone. I thank the hon. Member for Glasgow Central (Anas Sarwar) for bringing this matter to the House and for his speech, which was clearly based on careful consideration of a number of matters that have, properly, been brought to his attention by his constituents and by the action group to which he has referred.​

I concede that it is never attractive for a Minister to begin opening remarks by saying, “This particular issue is not within my brief.” Immediately, it sounds like trying to pass the buck to somebody else. However, notwithstanding that the issue is not within my brief—I am standing in for the Minister with responsibility, who is unfortunately unable to attend this debate—I assure the hon. Gentleman that on my return to the Department of Health, I will speak to the Minister’s officials and ensure that they are fully aware of all the matters that he has raised and the many questions that he has rightly posed, some of which I will be able to answer. I will ensure that all the answers are given, if not by me today then certainly in a letter.

I will speak directly with the Minister of State, Department of Health, my hon. Friend the Member for North Norfolk (Norman Lamb). Knowing him as I do, I am sure that he will be keen to meet the hon. Gentleman. It might take a little time—our diaries, as one might imagine, are fiendishly full—but I can see no good reason why my hon. Friend would not want to know more about the issue. Anybody hearing the hon. Gentleman’s speech, the arguments advanced and the stories behind this unfortunate condition would want to know more and to see whether anything can be done.

What we do know is that fetal anti-convulsant syndrome can occur when a mother must take anti-epilepsy drugs, as the hon. Gentleman has explained better than I can. We know that it can result—although, it is important to say, not always—in delays in developing speech and language skills in the babies born, difficulties with social interaction, memory and attention and physical defects such as spina bifida, heart defects, ocular abnormalities and characteristic facial features.

It is important to say that most women with epilepsy will have successful pregnancies and healthy children. However, epilepsy during pregnancy can pose challenges. Epilepsy is associated with the risk of giving birth to a disabled child, and for women on anti-epilepsy drugs, the risk is greater. Pregnancy may also increase the frequency of seizures in about one third of women, and it can alter their metabolism of AEDs. Prolonged fits can be dangerous for the baby as well as the mother, so ideally, pregnant women should be seizure-free.

The hon. Member for Glasgow Central rightly made the point that women have been diagnosed and prescribed this treatment but have not had sufficient explanation of the risks involved in continuing to take that form of medication, which many epilepsy sufferers take without any difficulty, for the sake of their health because of its positive effect.

I commend my hon. Friend the Member for Lancaster and Fleetwood (Eric Ollerenshaw) for the important point he made about the role of general practitioners in ensuring that National Institute for Health and Clinical Excellence guidelines are followed. I have those guidelines in front of me and what they say is important. It is all well and good that the pros and cons of the medication are set down, but it is also imperative for GPs and everyone else involved in the treatment of a woman with epilepsy who is thinking of becoming pregnant or is of childbearing age to understand the potentially bad consequences of taking AEDs throughout a pregnancy. Such women need proper information and a full and ​frank discussion so that they can make an informed choice—I emphasise that it should be an informed choice—before and during pregnancy.

The NICE guidelines are clear:

“In women of childbearing age, the risk of the drugs causing harm to an unborn child should be discussed and an assessment made as to the risks and benefits of treatment with individual drugs…In girls of childbearing age, the risk of the drugs causing harm to an unborn child should be discussed between the girl and/or her carer”—

in most cases, a parent—

“and an assessment…made as to the risks and benefits of treatment with individual drugs…Prescribers should be aware of the latest data on the risks to the unborn child associated with AED therapy when prescribing for women and girls of childbearing potential…Specific caution is advised in the use of sodium valproate because of the risk of harm to the unborn child”.

The NICE guidelines could not be more clear, but proper information sharing and full and frank discussion are critical to informed choices.

Anas Sarwar
I thank the Minister for reading out the NICE guidelines, which I have also read. When that system fails, however, as it clearly has for so many years, affecting thousands of families, what happens then?
Anna Soubry
Indeed. I was about to move on to that very point, which was also made by the hon. Member for Strangford (Jim Shannon), and to discuss support for children who have such an affliction, obviously through no fault of their own or of their mother. Before I do so, let me add that data related to the safety and use of AEDs during pregnancy remain under scrutiny; the information and the advice are updated and issued as appropriate. The MHRA regularly reviews both the evidence on AED use in women of childbearing age and the information provided in the product information and in patient information leaflets—although many people think that we are lucky if anyone reads leaflets in boxes, and that they are not the way to convey information to a patient; they are no substitute for sitting people down and telling them face to face, going through everything in the manner I have described. The important fact is that we are continually scrutinising the information and advice so that they are regularly updated.

On the specific point about children with this unfortunate condition, better care and outcomes for disabled children are a priority of the Government. The mandate to the NHS Commissioning Board sets out our ambition to give children the best start in life and to promote their physical and mental health and their resilience as they grow up. At national level, the new Children And Young People’s Health Outcomes Board will bring together what my brief describes as key system leaders in child health to provide a sustained focus on improving outcomes throughout the child health system. The Children and Young People’s Health Outcomes Forum will provide continuing expertise in child health and offer constructive challenge as we take forward plans to improve the system.

Those are fine words, though the brief was not written by me—it is not in the nice, clear, plain English that I would like. When I return to the Department of Health, however, I will make the point that, given the structures and our good, strong ambitions, it is imperative for us ​to ensure that the case of children who suffer from the syndrome is advanced within such forums, and today’s debate will help with that.

Anas Sarwar
The Minister says that she likes plain language, and I, too, like plain language. With due respect, any family with a child suffering from such a condition will not want to hear strategy documents; they want to hear what specific action is to be taken to help such families, what compensation they might get, what action is to be taken against the medical companies, or what change of structure will take place in the health service to prevent such failures happening again. They do not need strategy documents; they need plain language and action. What will they get?

Anna Soubry
I am trying to assist the hon. Gentleman by explaining that women with epilepsy should, from the very outset, get proper, sound information and should have a full and frank discussion with their medical practitioner so that they can make an informed choice based on everything put forward and knowing the pros and cons. There are many pros—[Interruption.] I prefer not to be heckled. I am happy to give way, and I will in a moment, because I do not have a difficulty with doing so.

I was absolutely clear in my explanation. I then discussed a series of organisations and structures—call them what you will—that also make it clear that the health and well-being of all children, including those who suffer from this syndrome, must be considered, and they must be looked after and cared for as we all wish them to be. The hon. Gentleman now seeks for the spotlight to be turned on this particular syndrome as it has perhaps not been before, and he is achieving that through the debate and by bringing me to this Chamber so that I can assure him that I will take the matter back to the responsible Minister. The hon. Gentleman has already pushed the syndrome up the list of priorities by casting the spotlight on to it, as should be the case.

Furthermore, services for children with special educational needs—some of the children we are discussing will need such services—will be enhanced by the provisions in the ​Children and Families Bill. From 2014, local authorities and clinical commissioning groups—this is an important provision to understand—will commission services jointly to meet the educational, health and care needs of young people with SEN through a single, integrated assessment process. In other words, we are now beginning for the first time ever to integrate all the specific needs of a particular child, right across all the various departments and people involved, in a way that has not been done before. If we do that, we will undoubtedly see an improvement in the lives of those children.

Anas Sarwar
I assure the Minister that I was not heckling her; I am too much of a gentlemen to do that. I was trying to say yes to action on proper advice for potential mothers with epilepsy and to future guidance to stop the condition happening, but my direct question was about the support to be given to the families for whom that is too late. They already have the condition and the difficult circumstances. What specific support will they get?

Anna Soubry
Those families are already receiving support; no one is saying that the children have been completely abandoned and are not getting any support at all. Perhaps much more can be done but, as the hon. Gentleman knows, in a debate of this length and given the constraints placed on me or any Minister, he will not get an instant answer, especially without notice of such questions. If I cannot answer all his questions in the short time that we have, and the clock is against me, he will get a letter with all his questions answered. Furthermore, when I go back to the responsible Minister, the hon. Gentleman will no doubt get a meeting to follow.

I thank the hon. Gentleman again for securing the debate. He has cast the spotlight as it needed to be done, and I am sure that there will be positive outcomes as a result.