Cumberlege Report

Maria Caulfield Excerpts

Thursday 3rd February 2022 Westminster Hall

[The Parliamentary Under-Secretary of State for Health and Social Care (Maria Caulfield)]

I congratulate my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) on securing this important debate on Baroness Cumberlege’s review. I was not present for the debate six months ago, so I cannot comment on many of the points that were raised then, but I am keen to update hon. and right hon. Members across the Chamber on the progress that has been made, because I am passionate about improving outcomes for the affected women. Not only do I have a huge amount of respect for Baroness Cumberlege, with whom I am working extremely closely on the results of her report, but she is a constituent of mine. I assure hon. and right hon. Members that she is holding my feet to the fire on all her recommendations.

The findings of the review laid bare the consequences of a healthcare system that has failed to listen and has disregarded the experiences of women. We have heard that movingly in many of today’s contributions, and in many debates in the House, on issues such as painful hysteroscopies, the delay in diagnosis for endometriosis or polycystic ovary syndrome, or women being ignored for years while experiencing symptoms of the menopause. There is a running theme.

My right hon. Friend the Member for Maidenhead (Mrs May) is exactly right that women often call for change on these issues for many years before their voices are heard. That is why I am pleased that we have England’s first ever women’s health strategy; we set out the vision document before Christmas and we will set out the full strategy very soon. It includes the appointment of a women’s health ambassador, who will look specifically at the issues and priorities in the strategy. We are recruiting at the moment and should have someone in post very soon. That is to make sure that women’s voices are not just heard but acted upon, so that in years to come we are not in a position where women and the MPs representing them are saying, “We have spoken every six months, but the situation hasn’t changed.” I reassure colleagues that I take all these points very seriously.

[Alan Brown]

It is good to hear the Minister’s commitment to listening to women’s voices. Will she listen to these women and, in particular, her constituent Baroness Cumberlege about the need to provide redress for the women who have been harmed by these drugs?

[Maria Caulfield]

I will come to that point. The Government have apologised on behalf of the health and care sector for the time it took to listen and respond. We are doing more than apologising: we are changing the healthcare system so that it responds to women in a much better way.

As the hon. Gentleman has just raised the issue of redress, I will touch on it now. It is not just these cases where it is often difficult for patients to get redress and compensation. I gave evidence to the Health and Social Care Committee this week on the issue of clinical negligence. This week, we announced a fixed recoverable costs scheme, meaning that, for low-value claims, we can speed up the claims process, reduce legal costs and ensure that, whatever clinical negligence they have experienced, patients are able to get compensation as quickly as possible. The findings of the Cumberlege report highlight mesh, Primodos and sodium valproate. However, across the board, it is very difficult for patients to get redress, regardless of the clinical negligence they have suffered.

[Caroline Nokes]

I do not want to be too difficult, but I do not think it is any excuse to say that because it is difficult for everyone to get compensation, we should not try here.

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[Maria Caulfield]

I want to reassure my right hon. Friend that changes have already been made. When women were experiencing these problems, particularly with sodium valproate, compensation was mainly run by NHS trusts and individual organisations, which was very difficult and cumbersome.

We have introduced the duty of candour, which a number of Members have raised this afternoon. That duty means that when a mistake happens, hospital trusts and GPs have to be up front, own that mistake and explain it to patients. Very often, women did not realise that the problem was the sodium valproate or the Primodos; they thought something else had happened. The duty of candour means that hospital trusts and GPs are up front, that that apologise and that the process of redress is started as soon as possible.

Now that NHS Resolution has been set up, the process is as easy as possible for anyone with a claim of clinical negligence to come forward. As a result of the new system, between 70% and 80% of claims—I will correct the record if I am wrong—are now settled out of court, which is quicker and helps patients get the compensation they need. They have a fundamental right to that if clinical negligence has happened.

[Alec Shelbrooke]

I am listening closely to what my hon. Friend is saying. Is that data independently audited, and will it be made available? The reality on the ground is that although these things are in place, there are plenty of examples of people who feel that that is not the case, and that doctors and professionals are carrying on doing the same thing and not feeding back in. I welcome what she has said, but could an auditable trail be published to show what is happening and those who perhaps are not taking any notice?

[Maria Caulfield]

There are absolutely processes in place, including bodies such as the Care Quality Commission, which audit and inspect to ensure that the processes that have to be in place are being used. NHS Resolution is clear about the work it does, and its chief executive also gave evidence to the Select Committee this week on how the process should work. Of course, if patients feel that it is not working for them, we need to hear about it. We set up these mechanisms specifically to make compensation easy, quick and representative of the needs of those who are claiming, to make sure that they get the compensation they need as quickly as possible. That has not happened in the past; we fully acknowledge that.

The Secretary of State will announce a consultation on wider reforms to clinical negligence very soon, because we recognise that the system has not worked for people. It has been too bureaucratic, and the legal position and fear of going to court has put many people off. It does not need to be like that. We want to make it as easy as possible for people, whatever their clinical negligence claim.

[Mrs May]

I want to press the Minister. I apologise about that, but she will recognise from the debate that there is real concern about this. I have concerns about NHS Resolution and the way it operates. There are systems elsewhere, in countries such as Australia and Canada, where, at a very early stage, an independent medical expert, who is completely separate from the institution where the negligence has taken place, is brought in, and there is much more of a sense of no-fault compensation and of not needing to go to litigation. NHS Resolution gets involved in litigation, and it can take many years before that is resolved.

[Maria Caulfield]

Yes, absolutely. Part of the consultation we will announce shortly will look at international comparisons. One concern we have about some of the no-fault schemes is the caps on the amount of compensation that can be given. I think some countries have a £1 million cap. I am not an expert on how much compensation these ladies should be due, but we want to make sure that, if we set up systems like that—we are not closed to those ideas—they actually address the issues that these specific women face. We will look at those options in the round.

[Sir Mike Penning]

May I press the Minister and draw her back to the Cumberlege report? What she is talking about going forward sounds really good, and the proof will be in the pudding, as my grandmother would have said. But recommendation 4 of Baroness Cumberlege’s report for the Government talks about—this is my word—compensation. That is so important because, as we heard, some of these people have been caring for their loved ones for the last 50 years. They are not going to be here forever, and they feel enormously vulnerable that their loved ones, who they have looked after for all that time, will be left without their needs being met.

This is not all about the ladies who, for instance, took Primodos tablets. It is about the outcomes—in order words, their children, who are living with this today. We quite rightly concentrate when talking about sodium valproate, mesh and Primodos on what happened at the time, but the consequences of that are these people who are now in their mid-50s and 60s. What will happen to them? They will fall back on the state for PIP and other benefits when actually, recommendation 4 says in black and white that the Government should have sorted it out.

[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.

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[Maria Caulfield]

I take the hon. Lady’s point, but the vast majority of claims that come through NHS Resolution are settled out of court. We want to make sure that patients get the redress that they are entitled to. There are mechanisms other than going to court in place right now.

[Sarah Green]

My constituent has approached several legal firms who will not take on her case because the two surgeons who operated on her also work for the law firms advising them on whether such cases will be successful, so that option is not open to her.

[Maria Caulfield]

If the hon. Lady writes to me about that specific case, I am happy to look at it.

The Government published their response to the review in July last year and accepted the majority of the recommendations for improvement. I want to update Members on those because we are absolutely committed to making rapid progress in all the areas in our response. We have committed to publishing an update on the progress of all the recommendations that we accepted, and we aim to publish that in the summer. If colleagues want to hold my feet to the fire, they will certainly get a formal update in the summer.

We have made strong progress on some of the changes.

[Sir Mike Penning]

It is fortunate that we have so much time because we can ask lots of questions. Marie Lyon, the Primodos campaigner, has effectively been told by the Minister’s predecessor, “See you in court”. I do not know about the experiences of the other conditions, but the Primodos campaigners do not have money. They have the will, but they are completely exhausted. They pinned all their hopes on the Government accepting the report’s recommendations. These people will not get a no win, no fee arrangement or a pro bono. They will have to try to fundraise, and they will, but is that morally right when the baroness’s report and its recommendations, published by the Government, say that they should not have to go through that?

[Maria Caulfield]

Specifically on Primodos, there is pending litigation so it is difficult for me to comment while that is in progress, but, depending on the outcome, the Government will respond to that.

[Caroline Nokes]

I will go for valproate, because there is not pending legislation about that. Have I understood the Minister correctly? Is she saying that if the Primodos case is successful, the Government will review it, and the women who have had mesh implants or who are the victims of sodium valproate will not be expected to have to go down that legal route?

[Maria Caulfield]

If I touch on the points in my response, hopefully I will be able to reassure colleagues on the progress being made.

[Alan Brown]

The point is that Baroness Cumberlege says the Government have an ethical duty to consider redress, so what does the Minister say to her constituents about that ethical duty that should be placed on the Government?

[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.

[Hannah Bardell]

Does the Minister recognise that this is not only about compensation, but about exposing the failures so that they never happen again? Eighteen members of the Primodos support group have died in the past two years. That gives an idea of just how long people have waited. They should not have to wait any longer. Those who have died will never see justice.

[Maria Caulfield]

I absolutely take that point—that is the crux of the matter. For too long in the health service, there was no duty of candour. The health service did not acknowledge when mistakes were made. That is changing; there is now a duty to declare when a mistake has happened. There is also support for staff. I cannot remember who mentioned the whistleblower on Primodos, but there is protection for whistleblowers now. There are freedom to speak up guardians to support whistleblowers in the workplace, and the Care Quality Commission is happy to take notification from patients and staff if there are worries about unsafe patient care. That will trigger an unannounced inspection to look at the data. It is all about creating a culture of learning in the NHS, rather than one of blame that pits patients against clinicians—that is what we want to change. That is how we learn from the mistakes of the past and prevent mistakes in the future.

[Alan Brown]

I thank the Minister for taking one more intervention. She talks about blame and not pitting patients against doctors or the NHS. Is that not the whole point of the redress agency that was recommended, to take away that adversarial approach?

[Maria Caulfield]

That is why we introduced NHS Resolution to facilitate a quicker method of getting compensation to those who have been harmed through clinical negligence. I encourage hon. Members to look at the work of NHS Resolution. We are doing more to ensure a better experience for patients, but we are fundamentally committed to ensuring that those who have been harmed get the support they need.

[Sir Mike Penning]

The Primodos victims—I am not allowed to talk about the court case—have had no choice. They are in court now because the Government would not take on Cumberlege recommendation 4. It is all well and good talking about what will happen in the future, but they are living with this now. They are in court today. Surely the Government should settle with them now. Like the Minister has said several times, these things get settled out of court. Well, settle with Primodos victims now and they will not have to go through that.

[Maria Caulfield]

I cannot speak on active litigation claims, but between 70% to 80% of claims are settled out of court because that is the avenue we want to go down. It is not in anyone’s interest to go to court. I am happy to keep hon. Members updated. There will be a formal review in the summer, but I am happy to have my feet held to the fire to ensure we deliver on the Cumberlege review for those patients who have suffered.