Cumberlege Report

Liz Twist Excerpts

Thursday 3rd February 2022 Westminster Hall

[Liz Twist (Blaydon) (Lab)]

It is a pleasure to serve under your chairmanship, Mr Rosindell. I congratulate the right hon. Member for Elmet and Rothwell (Alec Shelbrooke) on securing this important debate, and I thank the Backbench Business Committee for making it possible. As the right hon. Gentleman said, over six months ago we debated this same issue in the main Chamber. We pushed the Government for responses on the recommendations of the Cumberlege report. Many Members spoke passionately at that debate.

Today I want to talk about sodium valproate and the impact it has had. I looked up my speech from last July in Hansard earlier, and my speech today is almost the same. Forgive me if I am repeating from Hansard, but I think it is worth restating these points while giving an update.

Sodium valproate has had an impact on so many people, including children and women who took the drug during pregnancy. I want to talk about my constituent Bethany Dodgson, a young woman affected by foetal valproate syndrome. She speaks up on this issue and does a brilliant job of making people aware of it. She is also a carer for her brother, who is more seriously affected by difficulties caused by foetal valproate syndrome, and does a brilliant job of that.

I want again to pay tribute to Janet Williams and Emma Murphy from In-FACT—the Independent Fetal Anti-Convulsant Trust—who have done so much to campaign on this issue, and to all those other women and other people who have campaigned. As I said last year, it is really scandalous that we still have children being affected by foetal valproate syndrome today because their mothers were not aware of the risk of taking sodium valproate during pregnancy. Emma and Janet have campaigned, as have other people; they have been through the records and talked to people. I am sure many of us here have talked to Janet and Emma as they have gone about their work. They have ensured that women are made aware of the risks if they are pregnant or considering pregnancy.

It is now 18 months on from the Cumberlege report, “First Do No Harm”, and what we have seen is one letter sent some months ago to warn women of the risk. There are still issues to be tackled, and Janet, Emma and others continue to work with GPs and others to ensure that there is awareness of the issue. There have been attempts in previous years, with greater or lesser success, to ensure that doctors were aware and warned their patients, but much more needs to be done actively to ensure that no more children are harmed.

I would like to talk, as others have, about the recommendations of Baroness Cumberlege’s report “First Do No Harm”. First, the Government have accepted the call for a patient safety commissioner; I know that it is in the process of being advertised and that an appointment will be made. That is significant and very helpful. There is some movement, as there was at the debate in July, but we still do not have a patient safety commissioner in place. I hope that will happen quickly. I urge the Minister and the Government to continue to act and to press for swifter action to ensure that a commissioner is in place and is effective in pursuing patient safety issues.

As I said in July, there must be a redress agency. That is one of the recommendations of the report. I am disappointed, as I know lots of the women are, that the Government have now said, “There will be no redress.” I said last July that going to the law for compensation or redress is no answer for people who have suffered from any of the syndromes we are talking about. They have already suffered enough, and going to law is further pain and torture. It is a trial on top of what they have experienced—and, in some cases, continue to experience, as do their children, daily. I ask the Government to think again about that.

I endorse what Baroness Cumberlege said in her report: there must be an independent redress agency, so that people are spared the pain of having to keep fighting in law for their rights. I hope the Government will think again, as the right hon. Member for Elmet and Rothwell said. I join him in calling for a redress scheme to be developed, even at this stage, to ensure that people do not continue to suffer and can cope with their conditions. These people have already had to live for years with the physical consequences for themselves or their family, without their views being heard. Please, Minister, think again, and take away from this debate the fact that there is cross-party support for a redress agency to compensate those people.

We heard about the patient reference group. When we spoke in June, it had been set up and was working. However, now that it has reported, there is no continuing involvement of patients in any successor group or body that would allow their voices to continue to be heard. I urge the Minister to look again at that, and to set up a patient reference group, or something with another name; the name does not matter. What matters is ensuring that the people going through this process are involved in what happens in the future. Please, Minister, look again at that. I am pleased that, since our last debate, the all-party parliamentary group first do no harm has been set up, and that Baroness Cumberlege continues to be involved and engaged on this issue, which is commendable. I know how hard she continues to work on this. However, that group was set up not by the Government, but by Members of this House and affected patients to ensure that their issues are not forgotten.

Finally, I will repeat what I said last year. Let us be clear: we are talking about a medical issue, but this is a women’s issue. It is an issue of women not being listened to and their concerns not being heard, and of action not being taken. Frankly—I will say it again—it is just not good enough. We need to ensure that their voice is heard. As we develop and consult on the women’s health strategy, which the Minister and I discussed in an Adjournment debate the other day, we need to make sure that we learn these lessons, and the lessons of so many other cases where the voices of women have not been heard and listened to effectively. The title of the Cumberlege report is, “First Do No Harm”. It is vital that this principle is looked at when we consider the women’s health strategy.

--- Later in debate ---

[Maria Caulfield]

I thank my right hon. Friend for making that point. Compensation can be claimed now. Our concern about setting up a specific body to oversee that is that that would not address the fundamental problem of why it is difficult to get compensation. However, it is a fundamental right of anyone who believes they suffered from clinical negligence to seek compensation, and we actively encourage that.

[Liz Twist]

This is really important. These people we have been talking about all afternoon are, as the right hon. Member for Hemel Hempstead (Sir Mike Penning) said, living with the consequences of those actions. Baroness Cumberlege is absolutely clear about setting up a redress agency to

“administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”

Recommendation 4 is that:

“Separate schemes should be set up for each intervention…to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.”

Going to the law is not an answer for these people. It is difficult, it causes anxiety and it is expensive. We need real action now to address the problem.

--- Later in debate ---

[Maria Caulfield]

I have addressed the points about redress, which is available. We are reforming the process of clinical negligence to make it easier for patients to get compensation without the need to go to court, and we are having some success in that. There is a very different system in place now compared with when many of these ladies were affected.

The patient safety commissioner was mentioned by some colleagues. The consultation proposed details for setting up the commissioner’s role. Baroness Cumberlege is on the recruitment panel for that position and will keep a close eye on the role of the commissioner. The advert and recruitment process is now up and running, and we expect to appoint someone very soon. I reassure colleagues that that appointment will be in place: the recruitment process has started, Baroness Cumberlege is on the panel to appoint the commissioner, and that commissioner will be independent—a point made by my right hon. Friend the Member for Maidenhead—of the Department of Health and Social Care, which will of course work closely with them. The commissioner will be able to scrutinise both the NHS and the Department itself.

On recommendation 5, about specialist mesh services, eight specialist centres are now operating in England, where women who have been affected by mesh implants can access treatment and mesh removal. A ninth is being set up in Bristol at the moment. I remain very open to colleagues’ experience of those mesh services. Women have the option to choose which centre they go to, but I recognise that that might involve great distances from where they live.

If women are not being referred to the centres, however, or if their experience of the centres is that their needs are not being met, I am keen to hear about that, because the whole point of setting the centres up was to ensure help for those women who have experienced mesh implants that have caused huge trauma—I take on board everyone’s points—to them, changing their lives and that of their families forever. If that is not working, the women’s health ambassador, the patient safety commissioner and I will look at that, because that was the whole point of setting up such services.

[Liz Twist]

Will the Minister say something about the specialist centres proposed for valproate and Primodos? They do not exist; I believe that the Government rejected them.

[Maria Caulfield]

Valproate should not be being used on women or girls able to have children, unless they have a pregnancy prevention programme in place. That is to ensure that patients are fully aware, if they need to take sodium valproate, of the effect on any potential pregnancy. The NHS also commissioned the paediatric neurosciences clinical reference group to support the development of pathways for care services, specifically to improve patient support and co-ordination on the pathway for sodium valproate.

Mechanisms are therefore being set up for those women and girls who need to take sodium valproate. I think my right hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) pointed out that, in other settings, a huge amount of work is done to ensure that those women do not get pregnant. Also, a multidisciplinary expert group with experience in responding to exposure has been established. It will report its recommendations to NHS England in March this year. We will follow up on those recommendations, but a piece of work is being done specifically on sodium valproate, which will help to prevent such problems in the future.

Recommendation 6 was on MHRA reform. The review highlighted the need for the regulatory agency to undergo substantial revision, in particular on adverse event reporting and patient engagement. As many Members said, instances were flagged many times by many different people—the women themselves, MPs in this place, charities and other bodies—but people did not listen, although the MHRA has a duty to do so.

The MHRA has now initiated a substantial programme of work to improve how it listens and responds to patients and the public, developing a much more responsive system for adverse event reporting and supporting timely and robust decisions involving patient safety. It has been consulting on a new regime for medical devices that makes patient safety, engagement and transparency more prominent.

To strengthen its commitment to patient engagement, the MHRA recently established an enhanced customer service centre to make it easier for patients to express concerns, whether about medicine or devices that are being used. The MHRA has also appointed a chief safety officer, Dr Alison Cave, who will lead its ongoing commitment to the recommendations.

On setting up a database to collect details of all implantations of devices, which is recommendation 7, we have already legislated for that through the Medicines and Medical Devices Act 2021. The Act created a power for the Secretary of State to regulate for the establishment of a UK-wide medical device information system. Alongside developing those regulations, more than £11 million has been set aside for the work, involving partners across the healthcare system to scope, test and cost options for that workstream.

On transparency for payments, which I think was raised by the hon. Member for Chesham and Amersham (Sarah Green), who spoke about the conflicts of interest between doctors and pharmaceutical companies or providers of surgical mesh, recommendation 8a highlights the need for greater transparency for payments made to doctors. The recommendation calls for a register of doctors’ interests and for recognised and accredited specialisms to be held by the General Medical Council.

As the Government set out in our response to the review, we agree that lists of doctors’ interests should be publicly available. We continue to hold the view that that information will be most accessible to patients if it is published by healthcare providers rather than by the GMC. We are taking that measure forward and it should be in place by July this year.

We are also working with professional healthcare regulators to be clear that all regulated health professionals—not just doctors—must declare their interests, and that that information must be published by their employers. That approach will give not just women but all patients the reassurance that there are no interests involved in clinical decisions made about their care. We are working with the Care Quality Commission and equivalent organisations, and with the devolved Administrations, to ensure that implementation is monitored and that there is local accountability.

Recommendation 8b touches on the mandatory reporting of the industry. It calls for the pharmaceutical and medical devices industries to establish payments made to teaching hospitals, research institutions and individual clinicians. On 24 January this year—just a few days ago—an amendment to the Health and Care Bill was tabled to give the Government the power to deliver on that important recommendation. That legislation will, I hope, come into law fairly soon. The amendment will enable the Secretary of State to make regulations requiring companies to report information about their payments to the healthcare sector. That measure will benefit patients, who will see payments made to their doctors or hospitals, and it will build on proactive initiatives by healthcare regulators and the industry.

I very much take on board Members’ feeling that it took too long to acknowledge the problems that those women have faced, whether because of mesh implants, sodium valproate or Primodos. Although this may not be of any reassurance for women who have already been affected, we now have measures in place to flag problems in the system. For maternity care and clinical negligence, for example, we have an early notification system so patterns of events around neonatal care and foetal abnormalities are picked up at an earlier stage, to get on top of the causes quickly. We are seeing improvements in maternal and neonatal outcomes as a result of that early warning notification system

We very much recognise that such problems did happen in the past, but measures are being put in place to make sure that they do not happen in the future. I certainly want to make sure that the women affected are getting the care and support that they need. I very much take on board the points raised by hon. Members. I am very happy to keep Members updated on progress. I meet Baroness Cumberlege regularly to address the issues raised in her report.

I reassure colleagues that many of these issues will feature in the women’s health strategy, which we will publish shortly. The women’s health ambassador, the patient safety commissioner and I will be working hand in glove to make sure that women’s voices are heard in relation to their healthcare, and that we end the pattern of women feeling that they are not being listened to, that they are palmed off, and that their concerns are not taken seriously.