Valproate and Foetal Anticonvulsant Syndrome
(Limited Text - Ministerial Extracts only)
Read Full debate
The Minister of State, Department of Health (Mr Philip Dunne)
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.
Norman Lamb
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?
Mr Dunne
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.