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Sodium Valproate and Pelvic Mesh

Volume 837: debated on Monday 25 March 2024


Asked by

To ask His Majesty’s Government what are the timescales for, and what progress has been made on, a response to the Patient Safety Commissioner’s report on options for redress for those harmed by sodium valproate and pelvic mesh, published on 7 February.

The Government commissioned the Patient Safety Commissioner to produce a report on redress for those affected by sodium valproate and pelvic mesh. We are grateful to the commissioner and her team for completing this report and our sympathies remain with those affected by sodium valproate and pelvic mesh. The Government are now carefully considering the PSC’s recommendations and will respond substantively, hopefully in the coming months.

My Lords, I thank my noble friend for that reassuring reply. However, as it has been five months since the Government received the advice from the Patient Safety Commissioner in October 2023, how much more time do patients and families need to wait for the redress that they so desperately need?

My Lords, I thank my noble friend for her tireless work in this area. It is something which, in the Chancellor’s very own words—because it was the Chancellor who, as Health Secretary, first commissioned the report—remains a top priority to both him and the Government. That remains the case. I spoke to Minister Caulfield about it just this morning, and it is a complicated area, but it is something that we are very keen to redress in the next few months.

My Lords, I am really grateful to the noble Baroness, Lady Cumberlege, for raising this issue. On previous occasions, I have raised my ongoing concerns about the use of sodium valproate, especially for patients with mental health issues incarcerated in hospital. Do the Government collect information on how many people have been prescribed this terrible medication in some cases, and whether it is being disproportionally applied, particularly to young men from minority communities in the mental health institutions?

I thank the noble Baroness. I will provide the precise figures, but the incidence has gone down by 34% in terms of the amount that has been prescribed. At the same time—and this is particularly fitting, as tomorrow is National Epilepsy Awareness Day—for some people, this is the only treatment for epilepsy that will work for them. It is therefore important to make sure that protocols are in place for prospective mothers and prospective fathers to make sure that, in those cases, they are not being prescribed sodium valproate, because in other cases it is often the only medicine that works.

My Lords, given that, sadly, errors and problems repeatedly occur in the NHS, how are the Government working with the devolved Administrations to ensure that a redress scheme is designed to be fit for the future as well as fit for the recognition of harm that has occurred? What will they do to ensure that trust in the NHS is maintained by an approach that encapsulates prospective monitoring and listening to patients and relatives for early detection of adverse events and avoids cumulative errors?

I thank the noble Baroness. I was actually speaking to Minister Caulfield about this just this morning, because she is in regular touch with the affected patient groups. They were talking precisely about some of the things around the Scotland NHS scheme in place in terms of redress. It is fair to say that there are some concerns in patient groups on some aspects of this, but underlying what the noble Baroness says is making sure that, whatever we do, we are trying to do it consistently across the UK because there should be one consistent approach. Likewise, we are learning lessons from these things as well.

My Lords, an ex-constituent of mine, after years of excruciating pain, the onset of returning cancer and no care plan, finally borrowed $47,000 to have the failed mesh implant removed in America. She now has her life back but is in deep debt. However, we learn that the Government will consider redress only in 2025. Can the Minister hazard a guess as to how many more mesh-induced deaths will have occurred by the time a single penny is paid out in compensation at this rate?

The 2025 date is the timetable that the Patient Safety Commissioner recommended in terms of financial redress. The point that the noble Baroness makes, quite rightly, is about the non-financial aspect: if you are suffering pain from it all, you want to be treated as quickly as possible. That is why we have set up these nine specialist centres to allow exactly that sort of redress to occur.

My Lords, can I remind the noble Lord that, of course, it was not a matter of months since this first recommendation came? The noble Baroness, Lady Cumberlege, recommended a redress scheme some years ago. Why was it rejected in the first place, and why are we waiting many more months, as the Minister said, when, as the Patient Safety Commissioner has said, the intention is

“an initial, fixed sum in recognition of the avoidable harm they have suffered as a result of system-wide healthcare and regulatory failures”?

Why are the Government being so slow to respond?

That is precisely what I put to Minister Caulfield this morning. She commissioned the review because her feeling was that the period from when my noble friend’s initial report came in until when Maria Caulfield was in post was too long. So it was absolutely she who commissioned it last year, and it is absolutely she who very much said that she is determined that there should be a substantive reply from us in the next few months.

My Lords, at the launch of the Patient Safety Commissioner’s report the victims of the Primodos scandal expressed great distress as they felt that they had been airbrushed out. Of course, the noble Baroness, Lady Cumberlege, recommended that they should receive redress, and they were treated the same way in the report as the sodium valproate and vaginal mesh victims. Can the Minister tell me what will be done to provide redress and ensure that there is appropriate treatment for the victims of Primodos?

Again, these are difficult areas. My understanding is that we are working from the conclusions of the expert working group in 2017, and its review of all the evidence was that it could not find a causal link between Primodos and the impact it had during pregnancy. This was again reviewed by the MHRA when more information was brought up in the last year. So I am afraid that, as we stand today, the evidence is not there that suggests that causal link.

My Lords, the Patient Safety Commissioner’s report is all the more valuable because it is drawn from patients’ experiences, including physical, psychological and emotional impacts and their daily struggle with accessing health and other key services such as social security benefits and special educational needs support for the valproate-harmed children they are raising. What is being done to support mothers and families as they cope with the indecision and delay over the Government’s response to the commissioner and await the vital support they need?

We have completed four of the initial recommendations in the report of my noble friend Lady Cumberlege, and another three are in process. The most important of those, to answer the noble Baroness’s question, is the setting up of these nine specialist centres which can provide the support needed, not just in terms of redress surgically or treatment-wise but in terms of the support that people need to help them cope with the issues.

My Lords, as important as this report and these findings are, this is part of a wider problem. Some 4,000 babies die due to pregnancy-specific conditions in the UK every year, but 73% of drugs given to pregnant women have no safety information. That is clearly unacceptable. The Minister knows that I have raised this issue with him before; please can he give an update on progress towards putting this right?

My noble friend is correct on this. Probably the best way to do that is to come back in detail in writing, because it is vitally important.

My Lords, in response to the noble Lord, Lord Hunt, the Minister said that Minister Caulfield had commissioned this report, but he misses out at least three years of work earlier. There was the report of the noble Baroness, Lady Cumberlege, and there was a long debate during the passage of the Health and Care Act when Nadine Dorries said she would look at commissioning something and then refused to do so. This is not recent history. Will the Minister please give this House a date on which the Government will come back to Parliament with a response?

The point I was making was that Minister Caulfield absolutely agreed with the point the noble Baroness makes that the delay had been too long, and so it was she who came forward and said that she wanted to commission the Patient Safety Commissioner to report exactly in this area. So that was her being proactive on all this. In the same way, she says that she is determined to get a response back in the next few months. I cannot give a specific date yet, because it is a complicated area which involves industry, many government departments and the devolved authorities. However, as the Chancellor said, this remains a top priority area for both the Chancellor personally and the Government.