Skip to main content

Independent Medicines and Medical Devices Safety Review: Sodium Valproate

Volume 810: debated on Tuesday 2 March 2021


Asked by

To ask Her Majesty’s Government, further to the report by the Independent Medicines and Medical Devices Safety Review First Do No Harm, published on 8 July 2020, what plans they have to bring forward a redress scheme for women and families who have been harmed by sodium valproate.

My Lords, the Government plan to respond further to the Cumberlege review later this year, as I committed in my recent Written Ministerial Statement. In the meantime, we are carefully considering the recommendation regarding a redress scheme for those harmed by sodium valproate, and measures are in place to limit the prescribing of this drug.

I am grateful to my noble friend for his Answer. Since my noble friend Lady Cumberlege published her landmark review, another 150 babies have been born suffering harm from in utero exposure to sodium valproate, to add to the 18,000 children—18,000, my Lords—who have been harmed in this way since the 1970s. These children belong to families whose lives have been turned upside down, and who often cannot afford the costs of caring for their damaged children. They need and deserve a redress scheme now. Why can the Government not move faster?

My Lords, I pay tribute to those who have put together the valproate registry scheme that became live on 11 February. My noble friend is entirely right. There are 22,095 people on the registry; 462 of them had 490 conceptions, and 180 women were prescribed in a month when they were pregnant. A redress scheme is not necessarily the correct solution to this problem. We are considering it extremely carefully, and when we publish our overall response to the Cumberlege review we will include our considered response to the redress suggestion

My Lords, the noble Baroness, Lady Cumberlege, concluded in her report that the system still did not know how to minimise the risk of future babies being damaged, despite 27,000 women of childbearing age currently taking valproate in the United Kingdom. In view of that, does it not make the case for a redress scheme absolutely persuasive?

My Lords, I will leave it to the response to the Cumberlege review to make the decision on the redress scheme. In the meantime, our focus is on a regime ensuring that those who take this important drug have the right advice to prevent them becoming pregnant. I emphasise that specialists review the treatment and ensure that an annual risk acknowledgment form is signed by the prescriber and the patient. This is an important measure ensuring that all those who take this potentially life-changing drug acknowledge and understand the implications of becoming pregnant.

My Lords, in our report we suggested that every pregnant woman who is on sodium valproate should be warned by her GP of the potential harm to her unborn child. Can my noble friend please tell me how many of the women exposed to this danger have been notified, and what the plans are to ensure that in future they are told? What incentive is given to GPs through the quality outcomes framework to ensure that they carry out this very important duty?

My Lords, as I explained a moment ago, there is an annual risk acknowledgment form signed by the prescriber and the patient, and that is shared with the patient’s GP. GPs should check that the patient has signed an up-to-date annual risk acknowledgment form each time a repeat prescription is issued. We have instituted a valproate safety implementation group that analyses, along with the MHRA, compliance with this plan. We acknowledge the review’s recommendation to introduce an indicator on safe prescribing in pregnancy for future iterations of the quality outcomes framework, and we will respond on that with the rest of the response to the review.

My Lords, redress is important, but so too is patient support. Could the Government confirm that they are considering the recommendation that a network of support centres should be set up to support those women who have been affected by Primodos, sodium valproate or vaginal mesh?

My Lords, I completely acknowledge the noble Baroness’s point. Support is incredibly important and our hearts go out to all those who have been hit by any of the three conditions covered by the review. We are absolutely looking at those recommendations to see how they may be implemented to provide the support that the noble Baroness rightly points out.

My Lords, could my noble friend please update the House on the timetable for the appointment of the patient safety commissioner, one of the key recommendations that I am delighted the Government accepted? I understand that that requires new regulations, and the Government have rightly said that we ought to take time to find the best and widest possible field, but surely that just underlines the urgency of the need to get going with this.

As my noble friend rightly acknowledges, the everyday workings of the commissioner require some work. That work is being finalised and regulations will be made setting out further details about the appointment and operation of the commissioner—for example, the terms of office, the finances and other support for the commissioner. Officials are now working with legal and appointment colleagues to firm up time- lines and begin both the regulations and the appointment process for the commissioner.

My Lords, is the Minister aware that, when his noble friend Lord O’Shaughnessy was the Minister, the noble Lord realised the harm that some women had suffered from taking sodium valproate when pregnant? The noble Lord’s support has been inspirational and has given hope to these victims. Will the noble Lord, Lord Bethell, in his position as Minister now, bring forward a much-needed redress scheme for these women and children who have been let down?

I am grateful to the noble Baroness for her tribute to my noble friend Lord O’Shaughnessy, who has done an enormous service to us all by championing this cause, both as a Minister, when he moved this review and made a huge impact, and since then with his patient and thoughtful advocacy of this important cause. He speaks very movingly and thoughtfully, and we are greatly influenced by his persuasion on this subject. The noble Baroness should be reassured that we are absolutely looking at the recommendations for a redress agency, and we will come back with considered thoughts on it when we answer the review in the round. Until then, I welcome all thoughts and advocacy on the subject.

I have two points. First, last summer only 41% of the respondents taking valproate said that they had signed an annual risk acknowledgment form, so I would like the Minister to reflect on the fact that some GPs are not doing the job that they should be in terms of protecting women. Secondly, those affected by thalidomide and contaminated blood have a redress scheme, but it took years for that to happen. We simply cannot wait years for this to happen for those suffering from the effects of sodium valproate.

My Lords, I welcome the noble Baroness’s point on the proportion of those who say they have filled in the form. Phase 1 of the registry is a helpful collection of statistics, but we are putting in place phase 2, which will help us to understand exactly how many patients who are taking sodium valproate have actually filled in the form. That will give us the concrete reassurance that we seek on this matter. I recognise that there are redress payments for thalidomide and contaminated blood, but redress payments are not necessarily suitable for every single misfortune that happens in the medical world. However, we will look very carefully at the case for sodium valproate and I take the noble Baroness’s comments on board.

Research from Konkuk University in South Korea has suggested that disabilities caused by the compound could cause autism spectrum disorder transgenerationally—in other words, afflict successive generations within families. What is the Government’s view?

I am grateful to the noble Lord for raising that study. It is not one that I am aware of, and I am keen to go back to the department to find out whether it has done any analysis of it. I will write to the noble Lord with a response.

My Lords, the report First Do No Harm underlines the hurt and devastation that can result from not making patients aware of the possible side-effects of drugs. The harm done by giving sodium valproate during pregnancy cannot be undone, and generous support should be provided. Does the Minister agree that, while the appointment of a patient safety commissioner is a move in the right direction, that in itself underlines the importance of keeping patients fully informed of possible side-effects and listening to their concerns?

The noble Lord puts it extremely well and I totally agree with the thrust of his point. For patients to have the right information about the risks of the medicines that they are prescribed is essential. However, if I may stray into a different subject, there is also patient choice. For many patients, sodium valproate provides an incredibly valuable relief from epilepsy and mental illness. It is a drug that continues to be prescribed because some have no choice and there is no valid alternative to the drug. The number of people being newly prescribed the drug—new starters—is down dramatically from previous years, but for some it really is an important part of their therapy. The decisions that they make are personal ones, and we should respect those.