Thursday 3 February 2022
[Andrew Rosindell in the Chair]
I beg to move,
That this House has considered the Cumberlege Report.
It is a pleasure to serve under your chairmanship, Mr Rosindell. I have secured a debate about fulfilling the recommendations of the Cumberlege report because I do not feel that we are making enough progress. We had a debate on the Floor of the House in July and a written ministerial statement on 21 July. To stay in order, Mr Rosindell, I will only say that the Minister’s answer to the debate and the written ministerial statement were disappointing, in many ways. In my opening remarks, I will seek to address why I believe that to be the case and, fundamentally, ask for certain updates. We are talking about people whose lives have been destroyed. Many hon. and right hon. Members will bring their own examples about various parts of the report, whether they are about Primodos, sodium valproate or mesh, but I will focus my comments on mesh.
I will not spend too much time going over the examples I gave during the debate in July, which can be looked up in Hansard, but I will say that people were given an operation that many did not need, which many were convinced that they should have. Some people did not even know it had happened to them. It took many years for the problems that arose to become apparent, and so those people have effectively been dismissed.
Like many Members, I have constituents who have had their lives stopped, especially women, although I will mention how the issue affects men as well. One constituent, who I have mentioned before, was a physiotherapist in her 40s who had had a child. She had mild incontinence after giving birth and was told to have the mesh implant, which she went ahead and did. Her entire life has been destroyed by that. Trying to remove it was described to her as being like “trying to take hair out of chewing gum”. We should consider that image when we think about the difficulty of the operation. We must not forget that the NHS did this, and the NHS has a responsibility to deal with it. I will make that point several times.
I have been contacted by a lady who is a constituent of my hon. Friend the Member for Thornbury and Yate (Luke Hall). Her name is Paula Goss and both she and he have given me permission to talk about her case. She set up Rectopexy Mesh Victims and Support in March 2019 after she was unable to find much research or information about the meshes that she had had put in. The group now has over 1,100 members, as well as members who have sacrocolpopexy vaginal mesh and hernia mesh. She is the ambassador and advocate for rectopexy and hernia mesh on the Mesh UK Charitable Trust, which has a further 2,000 members.
She had rectopexy mesh in 2014 as she was unable to clear her bowels. She was ill-informed by the now dismissed surgeon, who, as she found out from her notes, inserted three meshes—in the bowel, vagina and posterior. She says:
“All mesh types don’t necessarily show complications straightaway. My Pre mesh insertion issues started again around 9 months after the op, in which I was passed from pillar to post by all medical professionals saying my issues were the menopause or in my head. This went on from 2015 until September 2018 when I was admitted to hospital with a blocked bowel and bladder and had to have enemas and catheters, still they would not connect this to the mesh, upon doing a CT scan at this time they also found a large ovarian tumour, it was then discussed by my gynae oncologist at the BRI and Southmead NBT to do a joint op to remove the tumour and the mesh, due to the incompetence and lack of mesh removal experience at Southmead I ended up having the ovarian tumour removal in January 2019. Thankfully, after testing it was a large benign fibroma, following up with Southmead they then stated that they wouldn’t remove my mesh but would do an op to give me a permanent stoma—again, brushed aside and fobbed off, I sought a second opinion in London privately, whilst we are by no means rich, you can’t put a price on your health...I had to pay £32,000 for my removal, it took over 10 hours and they could not get all of it…two protacks in particular sit very close to the bifurcation of the inferior vena cava on the left and the common iliac on the right. Pre mesh removal I was found to have a heart murmur and I suffered pericarditis quite a few times. My histology on my meshes showed that I was not a candidate for polypropylene and should not have this inserted again…When I discovered I had hernias again I was neglected by the local hospital who at first refused to do a scan, saying I must have an ulcer. it was thanks to my private mesh removal surgeon who contacted my GP and insisted that I was referred for a CT which then clearly showed two large incisional hernias.
The consultant at Southmead stated he would only fix my hernias with polypropylene mesh. After I told him that I couldn’t have that, there was no option but to again look down the private route. Thankfully, my colorectal mesh removal surgeon was able to do this and a date was set for 6 January 2020. However, my hernia started to strangulate and I was luckily rushed to London by my husband, and had this op done on 28 November 2019. This cost £43,000.
This operation was by far the toughest and took a long time to get over, due to ending up with a seroma and now a hiatus hernia due to the trauma to my abdomen.
My journey has not been, and is still not, plain sailing, but I am one of thousands.
Whilst vaginal mesh gets a lot of coverage, ours does not. Rectopexy affects men, women and children…All three main types of mesh need to be included and talked about—bowel mesh, vaginal mesh…sacrocolpopexy and colporrhaphy vaginal mesh and hernia mesh...One of our rectopexy mesh ladies found out that the surgeon who put mesh in also removed her ovary without consent, she sadly committed suicide due to this event.
One of our rectopexy patients was just 15 when she had her mesh inserted. She’s early 20s now and now suffers complications and doesn’t even know if she will ever be able to have children.
We have other ladies in their 20s and early 30s suffering, who may not be able to have children.
We have many rectopexy bowel men on our sites who feel they have nowhere to go and no one who will listen to them.
This is the same for all hernia mesh victims too.
There are many real victims’ journeys that need to be listened to and taken seriously.”
That is what the report did, and why it was so appreciated by the victims, as they were finally being taken seriously. That is where the report’s value lies. Today, I once again push for it to be implemented in full as far as possible, and for recommendation 3 about redress, recommendation 4 and recommendation 5 to be reconsidered.
Recommendation 1 was for an apology. That apology was received in July 2020, given by the Government, but, as good as it was, their actions depend on whether they can justify what they are doing on recommendation 9. Recommendation 2 is:
“The appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The Commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices.”
The Government accept recommendation 2, and I ask the Minister for the latest update on that appointment. On 2 December last year, in the other place, the noble Baroness Cumberlege asked Her Majesty’s Government
“when the process to appoint the Patient Safety Commissioner will commence; and when they expect the Commissioner to be in post.”
In response, the noble Baroness Chisholm of Owlpen said:
“My Lords, we are making good progress towards appointing the first patient safety commissioner for England. We expect the appointment of the postholder by spring 2022.”—[Official Report, House of Lords, 2 December 2021; Vol. 816, c. 1443.]
As I said, I would like an update on where we are in that process.
Recommendation 3 is that:
“A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”
The Government do not accept recommendation 3. As set out in the Government’s statement,
“We have no current plans for a redress agency…We do not believe it is necessary to create a new agency for redress as it is already possible for the Government and others to provide redress for specific issues where that is considered necessary. Neither do we believe that creating an agency would succeed in making products safer as the report suggests, or that grouping existing redress schemes through a single front door would add value for harmed patients.”—[Official Report, 21 July 2021; Vol. 699, c. 72WS.]
I do not accept that it is already possible to provide redress where necessary, because my inbox, and I am sure those of several right hon. and hon. Members, suggests that that is simply not true. It is too vague and takes too long. When I talk about recommendation five, I will discuss where that issue comes to a head.
I come back to my point, which is that the NHS did this to people. I have said it before and I say it again: the problem is very similar to the thalidomide scandal. Eventually we got justice for thalidomide victims. People are just being fobbed off—I have many examples—and that is exactly what happened with thalidomide. Mr Rosindell, can you imagine living an active life, as we all do, and the NHS recommending something that means that you can no longer take part in what you were doing? Imagine being physically and mentally restricted and unable to fulfil your life’s ambitions. A full quango might not need to be set up, but at the very least we need a ring-fenced department in the NHS to bring those areas together.
Baroness Cumberlege specifically states in her report that her terms of reference prevented her from talking about individual compensation and redress. Is my right hon. Friend suspicious, like me and probably many others, that that was specifically written into the plan so that she could not do what my right hon. Friend is asking for?
That is where we have to dig into recommendation 4:
“Separate schemes should be set up for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim”.
The Government do not accept recommendation 4. That is exactly the same situation as with thalidomide. One of my earliest campaigns in 2012 was to extend the grant to victims, and my hon. Friend the Member for North Dorset (Simon Hoare) took that campaign further to make it a permanent grant. People will not recover from what happened, whether it was drug-induced or operation-induced.
My constituent who has had mesh removed emailed me only today to say that four years down the line things are better, but they have not improved to the point where she can really live her life. She says she is mentally exhausted and does not want to go on. She had a thriving physiotherapy career that she cannot go back to. She is only in her 40s and has the rest of her life to live. The Government have a responsibility because the Government run the NHS. I interchange the words “NHS” and “Government”, but the NHS is the Government. That is where this situation falls on the Minister:
“While the Government are sympathetic to the experiences of those patients who gave evidence to the report, our priority is to improve the future safety of medicines and medical devices.”—[Official Report, 21 July 2021; Vol. 699, c. 72WS.]
Trying to prevent further catastrophe is obviously very important—that is one thing—but thousands of people will suffer for the rest of their lives thanks to this treatment.
I will draw the distinction between this surgery and breast-enhancement surgery. Many people have had that done privately and then when there have been complications, they have had the operation to sort it out on the NHS. There is often a lot of debate around whether that is right or wrong. That is not where I want to go today. However, if we are willing to do that for things that people have had done privately, why are we not willing to redress the issues of people who have had things done by the NHS?
We are talking about women from their teens all the way up. Some people think the problem is with the elderly end of the population, but we are talking about those in their teens upwards. As I said, we did recognise the situation with thalidomide. I know that costs come into it, but there is a moral responsibility to redress the situation.
The right hon. Gentleman is making a powerful speech. Does he agree that there is a moral responsibility? Once the Government—whatever Government that is and wherever they are—have committed to review such a profound issue, and have essentially marched people up to the top of the hill, giving them faith and hope, they must then follow through. Leaving people in a state of suspended animation for such a long time, when they have already suffered so much, is just not acceptable.
I am most grateful to the hon. Lady for that intervention. She summarises the entirety of what we are trying to achieve. When I put in the application for the debate, I found no difficulty at all in getting sponsors who were one third Conservative, one third Labour and one third SNP. This is not about the colour of the Government. It is about the NHS, which will be managed through all colours of Government, and has been throughout its life. It is the responsibility of this place, and part of who we are, to do the right thing by people.
I ask the Minister to look at the thalidomide grant scheme and translate it across to those who, as a direct result of the issues raised, will not be able to fulfil their earning potential and will have to deal with physical restrictions and pain for the rest of their lives.
As well as compensation, which I think is what the right hon. Gentleman was talking about with “redress”, the Scottish Government, at least, are now progressing with a Bill to set money aside for people to get mesh removed through private surgery, fully funded by the Scottish Government. Does he think that that should also be considered by the UK Government?
Again, I am most grateful for that intervention, because people are having to turn to private care to get that surgery done—often by the same surgeons. There has always been a conversation about the NHS commissioning private medicine to help it, particularly when it comes to clearing the backlogs caused by the pandemic. That that is important. I will come on to that question in my comments about where we are going.
Recommendation 5 says:
“Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.”
The Government accept the first part of recommendation 5, on specialist centres for those adversely affected by mesh. I regret to tell my hon. Friend the Minister that it is not working. I have a document that I will read from Kath Sansom of Sling the Mesh. She sent me this information. These are women’s voices, in just January 2022. An 83-year-old says:
“I am disappointed. I was expecting help but just offered pain relief and physio. And I now have red inflamed abdominal inflammation. I wanted to know if all these problems were the mesh—the answer was that they don’t know.”
A 64-year-old says:
“Not sure about anyone else, my experience hasn’t been particularly good. For me the wait goes on and on. Offered pain management, didn’t get anything only offered physio. In 14 years I have had enough physio to last a lifetime. Latest offer yet another camera in the bladder, that makes 4 now. First removal 2019, been waiting ever since for stage 2. I feel the longer it goes on, they hope I will give up having surgery at 64 years old.”
“After a very long wait to see a specialist in the mesh centre, having scans etc. was told no real problems”—
“Mesh centres are a piece of paper over a cavernous crack!”
Another person says:
“I feel mesh centres are giving us false hope—and then the realisation that it’s all been pointless. They actually admitted at Nottingham that they would watch Leicester removing my mesh so that they could learn how to remove a TOT mesh! They looked disappointed when I said there was no way I was thinking of having it removed. I feel like I would have been an experiment. I’m scared.”
“I waited 12 months from referral by GP for my first appointment, then it has taken 3 years of various tests and appointments to get on the surgery removal waiting list. I have been on that list for 15 months so far. In that time, I lost my job that I’d had for over 16 years due to sickness record, I’ve been on the waiting list for pain management for over 12 months, and I am gradually able to do less and less due to the constant pain.”
Someone else says:
“Nottingham mesh centre same pro mesh surgeons that put in mesh in charge of centre referring patients to nearby Leicester Hospital for operation—what’s all that about!! It’s OK having Specialist Mesh Centres, but these doctors need to be trained by surgeons that are doing good jobs.
I’ve been hurt once by these surgeons that put mesh in, I’m not letting anyone near me unless they have done lots of successful removals. the sad thing is, because only 4 or 5 great surgeons do removals, you have to pay private, because their waiting lists are so long.”
“Kath, can you highlight the LONG waiting times please and referral to pain management, which has a long waiting list—we are talking years overall when all we want is this damned mesh removing sooner rather than later”
“Mesh centres, what mesh centres? Same doctors been under for years. No faith at all. Only know how to put it in, not take it out.”
Another person says:
“Been waiting 15 months, and still no appointment. Was referred to UCHL, which I have heard nothing from, even though the hospital referring has resent the referral a couple of times. Been told I have to go to my local now, which is Southampton which I have heard not one positive outcome from, so basically, funding it myself with credit cards as can’t put up with the pain anymore”
while another says:
“Suffered for years before I found out what it was. My GP referred me five years ago—doctor yawned in my face & denied it was plastic. Told me it was tape. Sent me round in circles for lots of tests and visited 8 different hospitals for mainly painful procedures before I was finally sent to St Mary’s (Manchester) 3 years ago for a translabial scan.
Was sent to Wythenshawe then back to St Mary’s & told I had to see pain management clinic before I could be offered a full removal.
Covid cancelled all appointments in 2020 then I had an SNS trial implant at Northern General Christmas ’21 for bowel control (it failed) & spinal fusion L4/5 year ago for stenosis then got wound sepsis, so back in DRI for two weeks in lockdown last March. Sure the mesh damage caused all this!”
Somebody else says:
“There is a stark contrast between NHS and private, it shouldn’t be like this. I saw Professor Hashim on 1st October, he examined me, confirmed issues and said he could offer me full or partial removal. If I had been able to cough up the money I would probably be getting removal February or March. I am in his area for the Bristol mesh centre so my consultant referred me straight to him after reading his report. I have not had any communication from Southmead Bristol yet, everything I am hearing about Bristol now is that I am going to have to go through the pain clinic and try steroids etc first. Why do we have to jump through these hoops with the same surgeon just because we can’t afford…£15,000”?
“Gynaecologist was dismissive and stated that women like me are depriving other women from benefitting from it.”
My right hon. Friend has made that point a number of a times during his speech, and it is worth highlighting. I know that my hon. Friend the Minister will do some great work on the women’s health strategy, but time and again my right hon. Friend has said that women’s voices are being ignored and dismissed. They are told that they are imagining things and that it is in their heads. It is not good enough.
I completely agree with my right hon. Friend. In fact, I will later make a couple of points on what I have discovered about women’s health. The way women are treated is quite appalling.
Another person says:
“I had my TVT in Exeter 12 years ago. Exeter consultant in 2020 told me I couldn’t be referred to Bristol. He said he would refer me to UCLH but I never heard from them, I rang in 2021 to be told UCLH hadn’t received any referral but they then put me on their wait list from when I’d been told the referral was made. I then heard nothing from them for ages so I paid for a private consultant at Bristol to be told I could have been referred to Bristol on the NHS in the first place. Bristol requested NHS tests in Exeter which were done in August 2021 and they referred me back to Bristol in October, so I am now on Bristol NHS list for removal”.
Somebody else says:
“Took 4 years to be referred to specialist mesh centre, after a lot of pushing and pushing for it, referred to Royal Victoria Hospital in Newcastle upon Tyne. The mesh centre was no better, more lies, gaslighting and a really appalling treatment and total indifference, lots and lots of mistakes, cancelled appointments and no regard for any pain or suffering.”
Another person says:
“Told too dangerous to remove…left in agony...self-catheterising, lost job, pain management referral but they are behind 12 months …invisible and invalid is how I feel…is this my life at 54?”
Somebody else says:
“I went for a consultation for removal in 2020 had a scan then asked to contact his secretary when I’d had an MRI which I did in December 2020. Now still waiting for them to contact me. I leave messages and nothing happens.”
I could go on and on and on, and I am sure that many other right hon. and hon. Members will be raising similar cases. What I want the Minister to comment on in today’s debate is this. There is now, from the relevant royal colleges, the “Purpose Statement for the Mesh Complications Management Training Pathway”. That statement outlines several areas, but I will highlight just the “Mesh Complication Management credential”. Its subheading is “Professional Identity: Clinical Expert” and it states:
“The doctor has the knowledge, skills and attitudes required for clinical assessment of patients presenting with suspected mesh-implant complications…The doctor is able to investigate mesh complications, and interpret the results of tests, appropriately…The doctor is competent in non-surgical management of mesh complications…The doctor is competent to undertake mesh removal surgery as part of a multidisciplinary team”.
This is progress, but I think we can all understand that there is going to be a long time around that, so I say this to the Minister. Can the House please have regular updates on how this training process is going, within the royal colleges, for surgeons, because we need to understand what the process is and how long it is taking to try to deal with the main issue?
That brings me to the other parts of recommendation 5 in the report of the independent medicines and medical devices safety review. The written ministerial statement in response said:
“Recognising the need for enhanced data collection on pelvic mesh, the Government in 2018 announced the provision of £1.1 million for the development of a comprehensive database of urogynaecological procedures, including vaginal mesh, to treat pelvic organ prolapse and stress urinary incontinence. I can update the House that the pelvic floor information system has started to receive live data, including historical data from July 2017 onwards, with an initial focus on supporting specialist services to report every pelvic floor and comparative procedure to this national database.
The report of the IMMDS review also recommends that the information system is accompanied by a retrospective audit of mesh procedures, and by the development of a patient reported outcome measure (PROM) or patient reported experience measure (PREM). I am pleased to announce to the House today that the Government accept both these recommendations. NHS Digital has been commissioned to scope and deliver the retrospective audit. Subject to receiving high quality research bids, a new validated PROM for pelvic mesh procedures will be commissioned through the National Institute of Health Research in 2022.”—[Official Report, 21 July 2021; Vol. 699, c. 73WS.]
Again, I ask the Minister whether she can update us on progress in these areas and, after today’s debate, could she speak to her Department about ensuring, even if it is just through a written ministerial statement, that there is a regular update on the progress being made?
I will give a summary of the points that I have made. GPs are unaware of mesh complication centres and the referral process. Many patients are denied access and offered physio and pain management instead. They pay thousands of pounds for private care. They experience extremely long delays for appointments. Many women end up seeing their implanting surgeons, who then dismiss them. That leads to further deterioration in their physical and mental health. There is a lack of experience, particularly in mesh removal. There are only around four to five surgeons in the UK who can do mesh removal. There is no post-op aftercare.
More positively, on recommendations 6 and 7, the Government announced that the MHRA
“has initiated a substantial programme of work to improve how it listens and responds to patients and the public, to develop a more responsive system for reporting adverse incidents, and to strengthen the evidence to support timely and robust decisions that protect patient safety.”
Recommendation 7 was:
“A central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures.”
The Government accepted both recommendations. Again, I ask the Minister for an update.
Recommendation 8 states:
“'Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors' particular clinical interests and their recognised and accredited specialisms. In addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.”
The Government said that they accepted the recommendation in principle:
“We agree that lists of doctors’ interests should be publicly available, but we do not think that the GMC register is the best place to hold this information”,
so “publications of interest” should be held by healthcare providers. Having approved the recommendation, how is that progressing and how easy is patient access?
Finally, we get to recommendation 9:
“The government should immediately set up a task force to implement this Review's recommendations. Its first task should be to set out a timeline for their implementation.”
The Government accepted the recommendation in part.
Having probed the recommendations to open the debate, I ask the Minister whether she and her Department are able to say positively that they are meeting recommendation 9. Are the recommendations being implemented properly and is she revisiting the recommendations rejected by the Department initially? We can all recognise from the examples that I have given that the mesh centres are not working, that people’s lives have been destroyed and that they will need to support throughout their lives. We cannot just draw a line, have a year zero and say that we hope such things do not happen again. We have to move forward.
Drawing on what my right hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) said and on my research, it is clear to me that the NHS is constantly failing women. During the pandemic, I read a report—unfortunately, I have not been able to reference this since, so it is open to challenge—stating that gynaecological surgeons were taken off their operating theatres for longer than any other surgeons, being kept on the frontline of the covid wards.
That says exactly where the problem in the NHS lies. That comes up not just in this debate, but next week, in another debate, on problems with endometriosis. It seems that the NHS is—I do not say this in a positive way—gender-blind to the needs of women and the complications that occur. It is an attitude, a built-in psychology, that we will have to address, and we can only start to do so if we take all the aspects of this report seriously.
Although men have mesh issues too, this debate is dominated fundamentally by women’s health. It speaks to that wider assessment of NHS priorities on women. We have to start doing something about that. We must stand up and say that we are not afraid to criticise areas of the NHS, because I am sure that as we go through the debate we will have example after example from which we can draw only one conclusion: women are being failed.
My hon. Friend the Minister, as a practising nurse, will know the importance and vocation of patient care. With her professional eyes, will she allow the NHS to ignore the plight of people who are suffering every day? To be blunt, her predecessor appeared to. I ask her to apply her considerable and dedicated professional expertise to get the Government to direct the NHS to adopt the recommendations, or at least to mirror them. That is the least we can do for the terrible and horrific damage that the NHS has caused to so many people. To finish: the NHS did this, so the NHS must fix this.
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.
As others have said, it is a privilege to serve under your chairmanship, Mr Rosindell. I add my congratulations to my hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) on having secured this important debate. We are here for a significant reason, which is, frankly, to hold the Government’s feet to the fire and press them on why they have not made more progress on this issue. As others have said, it was debated some months ago in the Chamber of the House of Commons, and the cross-party support for Government action was absolutely clear, as the presence here shows, yet we have had to come back to ask the Government why they are not making more progress.
The independent medicines and medical devices safety review was absolutely clear about the damage done by the three medical devices and medicines that it considered: Primodos, mesh—not only vaginal mesh—and sodium valproate. As my hon. Friend the Member for Elmet and Rothwell—
I am so sorry; that must have changed after my time. My right hon. Friend set out very clearly how people’s lives have changed. The hon. Member for Blaydon (Liz Twist) has just done that as well.
Lives have been not just changed, but significantly damaged. People have suffered physically, mentally, socially and, in many cases, economically. As well as suffering the direct impact of what was done to them and, in the case of Primodos, to the babies born with defects as a result of their mothers taking it, they suffered constant rejection by the state—by the NHS and the Government, the very bodies that should have been there to protect and support them. The longer it takes the Government to fully implement the recommendations of the Cumberlege report, the more rejection these people suffer. Every week that goes by is a further rejection, because the report was very clear: action needs to be taken.
I was pleased to set up the report, and I commissioned it largely out of the concern I had about Primodos, which had been raised with me by my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning), but also by our former colleague Seema Kennedy, who took up this issue as well. The aim of the review was not just to get to the truth, but to identify what needed to be done to redress the problems that had occurred, to provide support to those who had suffered, and to ensure that it could not happen again.
There are two glaring aspects to these issues. The first is that the natural reaction of the NHS and the medical establishment was—and, I fear, continues to be—to defend themselves, rather than to admit to mistakes, ensure that those who suffered were given the support they needed, and take action to ensure that those mistakes could not happen again. That is still happening.
I spoke to a constituent earlier this week who had an operation a number of years ago, and is still having operations to correct problems that arose from a mistake made in that operation. My constituent Hugh Whitfield, a former consultant surgeon who runs the Independent Medical Negligence Resolution, spoke to me before Christmas about the large sum of money the NHS spends on litigation and on trying to defend cases in court, when a better system would be to just accept that mistakes were made. I have constituents who just wanted an apology. They just wanted to know that somebody had accepted that something had gone wrong, and to be shown that it would not be allowed to happen again. Instead, the NHS spends significant sums of money trying to defend itself in court cases when there is a better solution. That is slightly aside from the main point I want to make about the Cumberlege review, but it shows that the NHS’s attitude is to defend itself, rather than accept that mistakes were made.
I want to pick up on a point made by the three Members who have spoken. Sadly, when we look at the three issues that the Cumberlege review considered, we see a patronising attitude towards women—a pat-you-on-the-head attitude. “There, there. This is the sort of thing you can expect. You’re in pain? Oh well. You’re a woman.” I am afraid that that was the attitude taken on some of these issues—and it was not just that: it was a female doctor, Isabel Gal—a woman who had survived Auschwitz—who first identified the problems with Primodos, but she was dismissed and ignored, and sadly her career was damaged as a result. She eventually left the medical profession. What comes through in the report is that there is an attitude of not being willing to listen to women’s voices, and of not accepting it when women say, “Actually, what you have done to me is causing me extreme pain and difficulty.” Instead of saying, “You know what? I do this, and I get it right. Go away, dear,” professionals should say, “Let’s look into this and find out exactly what happened, and whether we made a mistake.”
I come to three of the specific recommendations, one of which is to appoint a patient safety commissioner. Reference has already been made to this, and it is good that the Government have accepted the recommendation, although they needed a bit of a nudge in the House of Lords to do so. What concerns me is the need to ensure that this patient safety commissioner is not in hock to the Department of Health and Social Care.
My right hon. Friend the Member for Elmet and Rothwell spoke about the NHS. Yes, these are the actions of the NHS, but behind it lies the Department of Health and Social Care, which consistently resisted properly looking into these issues over a significant period. I do not want a patient safety commissioner to be taken over by the Department of Health and Social Care. It has to be somebody who can be independent and can genuinely give patients a voice.
On the recommendation to establish a redress agency, my right hon. Friend the Member for Hemel Hempstead is right that under its terms of reference, the Cumberlege review was not able to look at compensation for individuals, but it was asked to look at wider redress measures, and it proposed the redress agency—a proposal that, sadly, the Government have not been willing to accept. I know the Treasury will have heard the proposal as, “Ding, ding, ding! Pounds!”—I have dealt with the Treasury, and we all know what happens—but the agency would have a wider remit than that. The Treasury often thinks these things are just about funding and monetary compensation, but people who have suffered as a result of these issues need other sorts of support given to them—for example, support for children with special educational needs. Redress is wider than monetary compensation, which is often what Government think about.
Recommendation 9 is to set up a taskforce. The patient reference group is a good idea but, as the hon. Member for Blaydon (Liz Twist) said, where now? The taskforce would have the job of gripping this issue and pressing down on the accelerator for action. I ask the Minister: who in Government is gripping this issue and pressing the accelerator for action? As I am sure she will gather, most of us here think that nobody is doing that, and that the issue is being allowed to drift. It is important that these recommendations be followed up on.
My final thought is about levelling up—a term that some of us in politics like to use at the moment. The victims of these three issues need to have their lives levelled up with those of people who did not suffer as a result of this. Above all, NHS treatment given to women needs to be levelled up with that given to men, to ensure that women are not just patted on the head and told to go away.
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 the debate. Without being facetious, I think it is the first time in my seven years in this place that I have agreed completely with his entire contribution.
The right hon. Gentleman focused on mesh. I will talk more about sodium valproate, but I agree with everything he said, and I have dealt with a constituent who came to me after her life was ruined by a mesh implant. She was suffering from pain and—others have mentioned this—economic hardship, as she had to reduce her hours at work, but she was lucky that she could still work three days a week. On top of all that, her personal independence payment for mobility was taken away, and I had to fight in Parliament to get it restored. That is a further way in which the state is letting down some of these people. They have already suffered from the operation; then they do not get the support they deserve, let alone the redress we are talking about.
I want to make the case for my constituents Mr and Mrs McKerrow and their daughter Claire. Mrs McKerrow was prescribed sodium valproate and Claire then suffered foetal anticonvulsant syndrome, which has affected her entire life. It has also affected her parents, and they have long campaigned for justice. They tried legal action, but were let down. They have been part of support groups. They engaged with and gave evidence to the Cumberlege review, so I can only imagine how hopeful they were when the thorough and comprehensive report from Baroness Cumberlege was printed.
Paragraph 1.38 states that
“valproate has caused physical and neurodevelopmental harm. We believe that the state and manufacturers have an ethical responsibility to provide ex gratia payments to those who have experienced avoidable damage from the interventions we have reviewed.”
The key sentence in paragraph 1.38 is:
“Patients have waited far too long for redress.”
I can only imagine how disappointed and angry people were when the UK Government ignored that in their response in July 2021. What a let-down! How can the Government ignore the key recommendation, which says that those affected by the interventions reviewed have waited too long for redress? As the right hon. Member for Maidenhead (Mrs May) said, every week is another week that those people are waiting and suffering.
As the right hon. Member for Elmet and Rothwell said, the UK Government have accepted recommendation 1 and issued a full apology, but that apology is somewhat hollow unless they consider setting up a redress scheme for those who underwent these interventions. On one level, it feels like an apology from the Prime Minister—absolutely meaningless. We should not be surprised that the Government have so far also ignored recommendation 3 —that a new redress agency should be created. The report states that such an agency should be
“based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”
That all sounds logical, and one would think that the Government wanted to address this issue, so hopefully the Minister will explain exactly why they have rejected the recommendation. Importantly, what other agencies in other countries have they reviewed? Baroness Cumberlege said that such agencies operate successfully elsewhere; what review did the Government carry out of those agencies before choosing to reject the recommendation?
Prior to the Cumberlege review, my constituents the McKerrows had made significant progress; they dealt directly with the BBC, professors of medicine, GPs and hospital consultants at each and every stage of Claire’s life in order to demonstrate the link between taking sodium valproate while pregnant, the disabilities that their daughter has suffered, and the ongoing impact on her growth, development and ability to have a normal family life. As I said, they took part in a Cumberlege review meeting and gave evidence. Mr McKerrow explained to me that redress, which we know is morally due, as was stated in the review, would put him at ease by protecting his daughter and addressing her future needs.
The Cumberlege review rightly talks about the psychological damage done to those harmed by the various interventions, but there is guilt for the mothers who took a medicine—sodium valproate—that caused damage to their child. Of course, they are completely blameless, but that is not exactly how the mind always operates. That is another aspect of people’s fighting to get justice, and to right the wrongs of being prescribed a harmful drug.
On redress, I recently submitted a written parliamentary question in the naive hope of getting a more positive response on compensation for the harm caused by sodium valproate. However, the Government’s answer stated again that they
“did not accept the recommendation to establish separate redress schemes for the three interventions in the report, including sodium valproate. Our primary focus is on improving future medicines and medical devices safety and it is therefore crucial that we focus Government funds on initiatives that directly improve future safety (including specialist mesh centres and support for families affected by medicines in pregnancy).”
As the right hon. Member for Elmet and Rothwell said, the mesh centres are not working anyway. In the final part of the answer to my written question, the Government said:
“For this reason, redress schemes will not be established in response to the recommendation in the report.”
Can the Minister honestly look these families in the eye and say, “Look, we’ve apologised. It’s time to move on and look forward. We’re not going to deal with you just now. We want to focus on future initiatives”? Can she not see how absurd that position is? Does she understand that all the people who gave their time to the Cumberlege review in the hope that justice would be served were effectively kicked in the teeth by the Government’s rejecting the recommendation for a redress scheme? Why undertake the review and not adhere to the key recommendations?
I am looking for an explanation from the Minister, but in an ideal world, we would see a U-turn. U-turns can be ridiculed in politics, but sometimes they are very welcome. This is certainly one U-turn that I, my constituents and everybody else who has suffered from such interventions would welcome.
I pay tribute to everybody who has campaigned on this issue. I agree with every word of every previous speaker. I do not envy the Minister in having to reply to the debate, but I offer her an apology in that, because of an inescapable commitment that has been in my diary for many weeks, I will not be present for her reply. I gave my apologies to you, Mr Rosindell, in advance, and to our hon. Friend the Member for Altrincham and Sale West (Sir Graham Brady), who will be in the Chair later.
The issue was eloquently summed up by the hon. Member for Blaydon (Liz Twist) when she said that she could have reread her speech of 8 July word for word and it would have been as relevant today as it was then. Interrogating my own website on my contributions on this subject in preparation for the debate, I see that, apart from speaking on that occasion, my first effort on this topic was way back in a debate on 19 April 2018. I have to ask the Minister why, when terrible health disasters happen, it always takes so long to do the right thing. All that does is prolong the agony for the victims. I suppose the people responsible for trying to make recompense feel that they will be out of the picture by the time their successors have to pick up the pieces, but it smacks of the contaminated blood scandal all over again. Everybody knew that it was a horrible disaster, yet it took so many years, indeed decades, before compensation was finally paid.
I want to give a voice to three of my constituents, who have summarised their experiences for me, and if time permits to refer to just a few of the dozen or so multifaceted written questions that I have tabled, with differing success in terms of replies, between July 2020 and November 2021. Let me first précis the summary that my constituent Amanda, or Mandy, has prepared for me. She had a procedure in 2009 for the insertion of TVT—transvaginal tape. She says that
“the surgeons need to take responsibility and ensure that these failings are not perpetuated. The pain and suffering we have endured and continue to endure is traumatic physically, emotionally, and financially”.
She says that she has subsequently had to undergo many surgical episodes that would have been unnecessary, and that
“had I been aware of the risks and the fact that alternatives were available I would not have had surgery in the first instance. Partial removal surgery made things significantly worse. To date I have had 8 operations relating to the TVT.”
Mandy lists some of the costs that it has meant for her:
“Left in ongoing chronic pain
Loss of some independence
No intimacy possible
Relationship with husband negatively impacted which has an impact on work as we run a business together
Negative impact on my family and friends. I used to be happy and cheerful person, but this is now a constant struggle
Emotional stress of trying to appear ‘normal’ takes its toll
Feeling of being a failure as a woman and in my work life”.
The list goes on. Then she comes to the topic of the failure of the surgeon. There are three entries here:
“Failure to discuss risks prior to surgery
Failure to suggest alternatives to TVT
Failure to obtain informed consent”.
On the financial loss, I will not quote from her list, because others have set out the cost to them, but Members can be sure that it applies to Mandy as well.
My second constituent Helen, or Ellie, had two implants, in 2009 and 2011. This is what she has to say about the effects of these unnecessary procedures:
“Mesh has restricted my ability to work full time, due to constant pain, which has impacted negatively on my family…Mesh has cost me financially to travel for hospital appointments out of area. I’ve had to travel to London three times, staying in a hotel twice. Travelling to Bristol 9 times, staying in a hotel 7 times, as I am not able to sit to drive home on the same day due to pain. So not only fuel costs but hotel fees as well…Mesh has impacted negatively as I was told one operation would fix me, so one day’s lost wages, which ultimately has resulted in 9 more operations, each requiring weeks off work, each resulting in loss of income and now ending with one more surgery which could also require more follow up surgeries.”
She says that mesh, as in the case of Mandy,
“has cost me my sex life”
“which there is no financial recompense”
“Mesh has cost me the ability to care adequately for my disabled husband, who now has to try to care for me…Mesh costs me monthly for my pain medication.”
If time permits, I will refer to the brush-offs I have had when asking if Government would make it their policy to at least exempt these victims of NHS failure from prescription charges, with no success so far.
Helen goes on:
“Mesh costs me the price of a cleaner twice a week as I can no longer manage it all myself…Mesh costs me the pain of sitting in a car for over a two hundred mile round trip each time I go to see my consultant, as I can’t see my local butcher.”
That leads me on to something that has been hinted at before: it is all well and good to set up specialist mesh removal centres, but if the only choice people are given is to go to the surgeon who put the mesh in, who has now, after repeated failures, been appointed to take it out, would they seriously put themselves in his or her care again?
Finally, I want to talk about Emma, who is not only a victim of this herself, but someone for whom I am lost in admiration. She has acted, in a sense, as a focal point and a support for the other victims. Every so often she thanks me for what I have done to support them. I feel a complete fraud when she does that, because we should be thanking her for what she is doing as someone who is suffering from this and reaching out to support other victims. I know she is watching this debate on the feed today, and I express publicly my total admiration for her.
“Mesh has cost me my career. I am no longer able to fulfil the driving element of my job and have lost my Class 1 HGV licence as I cannot pass a medical…Mesh has cost me the ability to work at a desk, in an office, therefore restricting my earning potential, and in turn my pension contributions. It also restricts my ability to find alternative work…Mesh has cost me thousands of pounds in travel, subsistence, accommodation and parking…loss of earnings & annual leave…days off for appointments, surgery, recovery, and mesh-related ill health.”
That has all taken its toll. I could go on, but I will just pick one or two examples from the long list of the consequences of this disaster for Emma. She says:
“The battle to get any form of PIP was traumatic and stressful. The evidence was ignored, the condition insight report was not recognised (despite it being a DWP authored document).”
She goes on to say that PIP
“was only awarded (eventually) at an Independent Tribunal; which means I will have to reapply again, from the beginning, in just over 12 months’ time…All told, the entire situation is extremely draining mentally, emotionally and physically.”
Emma has also communicated with me while this debate has been under way, thanks to the wonders of modern technology, to point out that—as Southampton has been mentioned—there is, as yet, no named surgeon at University Hospital Southampton NHS Foundation Trust’s so-called specialist centre.
I conclude by saying that I have been disappointed with the series of responses I have had to my dozen questions, which are all easily accessible for anyone who cares to look on the written questions section of my website. I was most disappointed by the response to question 31274, from 12 July 2021, which asked, in part, what steps the Secretary of State
“plans to take to research new and improved techniques for removal of eroded surgical mesh implants; and if he will make it his policy to establish a unit for developing such techniques in order to train a new generation of mesh-removal specialists to treat people who experience the effects of failed mesh implants in the future.”
Bearing in mind what has been said about the intense difficulty of extracting degraded mesh from the flesh that has grown around it, I have often wondered whether there might be a technique to melt it away, rather than trying to extract it. However, if we do not do the research, we cannot possibly find a solution. The answer came, bluntly, from the then Minister of State, who is now the Secretary of State for Digital, Culture, Media and Sport:
“There are no current studies specifically relating to new and improved techniques for the removal of eroded surgical mesh. However, there are five studies ongoing on surgical mesh implants and the National Institute for Health Research welcomes funding applications for research into any aspect of human health, including on the removal or implantation of vaginal mesh. There are currently no plans to establish a unit in order to train mesh removal specialists.”
We know that only a tiny handful of people have successfully specialised in this field. They ought to be empowered to train up a new generation to help these people, whose suffering will otherwise continue indefinitely.
It is a pleasure to serve under your chairmanship, Mr Rosindell. I add my thanks to the right hon. Member for Elmet and Rothwell (Alec Shelbrooke) for securing this debate.
I would like to highlight the excellent work of the Epilepsy Society on sodium valproate. The Epilepsy Society is based at Chalfont St Peter, in my constituency, and its “Safe Mum, Safe Baby” campaign calls on the Government to fund research into safer epilepsy medication for pregnant women. It is a necessary and worthwhile campaign and I support it wholeheartedly. I hope the Government will give it due consideration.
I also pay tribute to my constituent Carol Nunn, who has given me permission to share her experience of surgical mesh. I understand from the Government’s response to the Cumberlege report that their priority is to make medicines and devices safer and prevent future harm. While that is good to hear, I agree with the right hon. Member for Elmet and Rothwell and others that maintaining this narrow focus entirely misses much of what is at the heart of the report, which is improving the lives of people who have already been harmed.
The Government have stated that supporting these women is one of their priorities. If that is the case, I do not understand why they repeatedly refuse to establish redress schemes. The Minister has claimed that there is no evidence that a redress scheme would improve the outcomes for these women. Respectfully, is the Minister really listening? Victims have lost jobs, endured relationship difficulties and financial stress and been left with chronic and often debilitating pain. They deserve redress.
I want to tell Members about Carol. When I first spoke to her last summer, she told me how, four years earlier, she had undergone a hysteropexy and rectopexy using surgical mesh. Instead of resolving her pelvic organ prolapse, the procedures left Carol with a serious autoimmune disease, struggling to walk and unable to continue with her normal daily life. She had to take long-term sick leave from her job as a medical doctor. She told me that she could not remember a day without pain.
I am pleased to say that today Carol is mesh-free following a successful removal surgery last year. She is the first person in England to have undergone successful rectal mesh removal. Although she is still suffering, Carol told me that she feels fortunate to have reached this outcome because, unlike many others, she was able to look outside the national health service and outside the United Kingdom. She feels fortunate because her professional training as a doctor gave her access to the knowledge and resources that allowed her to find Dr Veronikis—I apologise if I have pronounced that incorrectly—and fly out to the United States to have her mesh removed there. I am not convinced that anyone who has had to endure what Carol endured can be classified as fortunate, but I understand her point.
Having lost jobs and shouldered the financial burden of life-changing symptoms, others cannot afford to pay out thousands of pounds for private surgery or international travel to remedy harm that could and should have been avoided. That has now been acknowledged elsewhere in the UK. Last week, a Bill that will allow the Scottish Government to reimburse women who have had to pay for transvaginal mesh removal was passed in the Scottish Parliament. The Transvaginal Mesh Removal (Cost Reimbursement) (Scotland) Bill enjoyed cross-party support. I regret that it excludes the removal of mesh used in other parts of the body, but it is an excellent first step towards justice for mesh victims. I am pleased that patients north of the border now have access to support. I would like to be able to offer the same to my own constituents, which is why I urge the Government to look again at recommendations 3 and 4 of the Cumberlege report and to set up redress schemes.
I want to be clear: the mesh centres set up across the UK are, for many, inaccessible. For those, like Carol, who had rectopexy mesh, there is nowhere in the country offering removal without life-changing surgery involving the removal of organs. Carol, who is herself a doctor, described that type of surgery as barbaric. As has been mentioned, where removal is available the Government too often expect women to have the mesh removed by the same surgeon who inserted it. The choice facing victims is really no choice at all.
At the heart of the report is the recommendation that financial redress should be made available. In denying it, the Government completely miss the point of the report—the need to listen to victims. Baroness Cumberlege and her team met more than 700 affected individuals, mostly women, and found that they were not being listened to by medical professionals. Now they are not being listened to by their own Government. What is the point of commissioning a review if Ministers ignore one of its central findings? I hope the Minister and the Government will revisit the report’s recommendations and look again at offering financial redress, because ultimately it is the right thing to do.
It is a pleasure to serve under your chairmanship, Mr Rosindell.
Groundhog day—here we go again. This is almost the identical debate that we had before. If this was in the main Chamber, especially if it was not on a Thursday afternoon, the Chamber would be full, because there is not one constituency that does not have somebody affected by the three conditions. As the hon. Member for Chesham and Amersham (Sarah Green) said just a moment ago, what is the point of commissioning a report or having an inquiry and then ignoring the key components of its conclusions?
I congratulate my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) on securing the debate. Sadly, I think we will end up having more. I am a loyal member of Her Majesty’s Government. I am absolutely aghast that we are here again discussing this. I thank my right hon. Friend the Member for Maidenhead (Mrs May), our former Prime Minister, for her support. The report would not be here today without her.
I congratulate Baroness Cumberlege, along with Marie Lyon, who ran the fantastic Primodos campaign. There was some worry about the experts that the baroness had around her, and we questioned her on those points to make sure that the inquiry was truly independent. At the start, the all-party parliamentary group was very sceptical because we had been let down by the expert working group. What an oxymoron that is! It is an insult to experts. Those on the group might be experts in their particular field, but they are not experts in people.
I want to talk in particular about Primodos. As several colleagues have said, very vulnerable women went to their GP for help, because they thought that they might be pregnant. They were myriad different ages, from myriad different parts of the country and certainly from different economic backgrounds. This touched everyone. They went to their GP and said, “I think I might be pregnant.” That GP, in an NHS GP’s surgery, pulled open a drawer, gave them some tablets and said, “This will tell you whether you are pregnant”—no advice, no concerns, no documentation.
These days, I have to take some medication and it is like “War and Peace” when I open the packet—even if I buy an aspirin. Although that is understandable, as aspirin can be very dangerous, so I will not use that example—perhaps ibuprofen or something. Clearly, that is because the industry, the pharmas, know that they have to cover themselves because they might be sued.
The side-effects for some of those ladies and their families and loved ones have been so traumatic. Some had miscarriages, some were told to abort the child and some went on to have children with abnormalities that were frightening then and today. The type of disabilities were similar to those of thalidomide, and one might have thought that we would have learned the lesson of thalidomide—tainted blood, as my right hon. Friend the Member for New Forest East (Dr Lewis) alluded to earlier. But no—we have not learned those lessons.
Some people are alive today, but many have passed away. What is the Department waiting for? Is it, as with thalidomide, for these people to die early? That is why the fund for thalidomide ran out—the Department thought there was enough money in the fund, but people lived, because they have character and they survived, so we are about to top up the fund. These people, too, have lived, with unbelievable conditions. We, in Parliament and as a Government, surely should be here for them.
When the initial report of that expert working group was produced, many of us in the Chamber said that it was a complete whitewash. It was indeed a complete whitewash. The all-party parliamentary group had some evidence sessions with members of the working group, and I asked, “Who gave you the authority to change the ministerial guidance on what your report should look like?” They said, “Oh, we just thought that we would change it.” It was all about the evidential base—it was easier for them to come to the conclusions that they wanted to come to.
We said it was a whitewash, and the Government did the right thing: they got Baroness Cumberlege to look at the three areas—I apologise to the other groups, because I completely agree with everything that was said, as I have constituents in the same situations that have been mentioned. But what is the point of saying to these people, “Here’s the report by the baroness, and the Government accept some of it”?
I had the honour of being the Policing Minister when my right hon. Friend the Member for Maidenhead was the Home Secretary. The Hillsborough inquiry report was difficult. Governments of all colours had previously rowed away from the issue, because in general they were probably frightened about the conclusions—the conclusions were frightening. However, we did the right thing and we honoured the report. That is absolutely what should have happened with this report.
The Government, though, are turning around to say to these families that I am talking about today, and to the families involved with the other two conditions: “If you don’t like what we are saying, sue us.” I have been told that we have to be slightly careful not to go too much into the legal side of this, but they have fought all their life to look after their loved ones and to say, “This is not on me.” They were worried about the ladies who took the tablets, but men—the fathers of these children—have been told, “This was probably genetic. That happens.” That does happen, but this happened because NHS doctors gave these tablets to patients in an NHS surgery and did not tell them the risks, even though they knew them. Back in 1967, Primodos was removed because of the risks, yet it was still available in 1978. I had been in the Army for four years in 1978; it was not that long ago. They knew the risks, but they continued.
People ask me why GPs were doing this. It was because drugs company salespeople were going into the GP surgeries and pushing their product at the doctors, promoting it so they could earn more and more money. We need pharmaceutical companies. Many of the medicines that we have today would not have been invented without pharmaceutical companies. However, when they get it wrong, we have to hold them to account. They got it wrong, and the Department of Health got it wrong, and thus Governments—it does not matter what colour they were; I do not care—got it wrong.
We touched earlier on why we are fighting this. I had the honour of serving in six or seven Departments—I lose track sometimes; it was three at one time, I think—and I was told lots of times by my officials that we needed to fight or challenge something. That happened lots of times at the Home Office; my right hon. Friend the Member for Maidenhead is nodding away. I was the Disabilities Minister at the Department for Work and Pensions, and I asked why we were not settling with these people, because we had made a mistake. I was told that the Treasury counsel thought we might have a case, with about a 30% chance of success. Come on, guys.
At the end of the day, Governments are worried about saying, “Excuse me; we got it wrong and we are going to put it right.” The Government are going to put it right, we hope, but mistakes will still happen. That is the nature of medicine, I am afraid. But when we get it wrong, and doctors get it wrong, for once in their lives I wish they would just turn around and put their hands up. That is what I hear from my constituents in the complaints that come through my office; I am sure it is the same for all colleagues in this room. We see these reports and the amount of compensation that is to be paid, and they are challenged, and then eventually people get their money. There is something wrong.
I have sat in the Minister’s chair on more than one occasion and been bombarded, quite rightly at times. However, this is not about the Minister; it is about Government, and the structure of Government. Using the Minister as a conduit, this needs to go further, back up to the top and, at the end of the day, to the Treasury. The reason why people in government are so worried is because this could set a precedent. They are worried about whether it will cost the Treasury lots of money. Let us be honest: it will cost the Treasury lots of money, sometimes in ways that it is not even expecting. We have already talked about PIP and access to work. We could go on about the amount in benefits that this is costing Government anyhow. As well as that, the decent thing to do is to honour recommendation 4 of the Cumberlege report. It does not use the word “compensation” because Baroness Cumberlege was not allowed to use that; the terms of reference given to her were written to make sure that she could not. However, it says that this has been done to these people, we got it wrong, they trusted the Government and the Government have to compensate them.
I will say one final thing. The NHS is a wonderful organisation. Around the world, people look at our NHS and say, “We wish we had that. We wish we could do that.” This is damaging the NHS. This, tainted blood and thalidomide—we could go on about other things—are a danger. We rightly addressed tainted blood and thalidomide, thank goodness; the campaigning by the thalidomide action groups was absolutely phenomenal. This needs to be resolved before it damages the NHS even more. Colleagues will retire or leave. Some people—particularly those affected by Primodos—will pass away. But we will not go away. We will go on and on and on about it in this House until compensation—recommendation 4—is provided to our constituents, and that is the right thing to do.
[Sir Graham Brady in the Chair]
May I take the opportunity to thank the right hon. Member for Elmet and Rothwell (Alec Shelbrooke) for securing this very important debate?
The Cumberlege report makes nine strategic recommendations, and I will speak later on recommendation 3—to establish an independent redress agency. Other hon. Members have spoken eloquently this afternoon on the devastating effects of vaginal mesh implants and the drug sodium valproate, but on behalf of my constituent Nan McGradie and other individuals and families tragically affected, I will highlight specifically the dreadful harm caused by the drug Primodos.
In January 1975 my constituent, Nan, was prescribed two Primodos tablets as a pregnancy test by her doctor. It was subsequently confirmed that at that time she was about seven or eight weeks pregnant. There is considerable evidence indicating that those women who took the drug, prescribed by their GPs, and were pregnant at the time gave birth to babies with serious birth defects, including deformities and disabilities, missing limbs, cleft palates, brain damage, and damage to internal organs. In some cases the women miscarried or had stillbirths.
At the time, in 1975, Primodos had already been banned for use as a pregnancy test for five years in Norway and Sweden. When my constituent’s daughter, Michelle, was born in August 1975, it was immediately discovered that she had a hole in her diaphragm, which had allowed her bowel and spleen, part of her liver and kidney to be forced into her chest cavity, crushing her lung. Michelle was not expected to live, but thanks to the skills of our NHS she survived and is now 46 years of age. Throughout her life, Michelle has endured numerous operations and surgeries and long, long periods of hospitalisation, has suffered severe health issues, including breathing difficulties, a weakened immune system, numerous bowel obstructions and inflammatory bowel infections, and has been unable to conceive children. The effects of those debilitating physical and psychological medical and extremely challenging health conditions suffered by Michelle for the last 46 years just cannot be adequately described in words.
Let me return to the recommendations in the Cumberlege report and specifically recommendation 3, which states:
“A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.”
The final Government response to it states:
“We do not accept this recommendation. We do not believe that a redress agency would make products safer and support our commitment to patient safety. We also believe it is already possible for government and others to provide redress where this is considered necessary, the government therefore has no plans to establish an independent redress agency.”
The decision by Government not to establish a new agency is callous and cruel and takes no account of the suffering or experience of the people who suffered as a result of a failure by successive Governments to protect them. It was the Government’s responsibility to protect people. The decision not to establish an agency has resulted in anger, frustration and great sadness for all, but especially those affected by the tragic consequences of vaginal mesh implants, sodium valproate and Primodos. Those feelings are perhaps best illustrated by direct quotes from those most affected by the Government failures. They include members of the patient reference group set up under the Cumberlege report. That was designed to be a forum for the Government to listen to the views of the people affected.
The people who took part in meetings of the patient reference group agreed that if the recommendation for an independent redress agency is not taken forward, those harmed by such medicines and medical devices, both in the future and in the past, will never get justice. They strongly rejected the notion that litigation was a viable substitution for a redress agency or as an acknowledgment that patients have suffered harm. Many people just do not know where to seek redress for harm, and many cannot access legal services, primarily because of the cost. It should be noted that many of the victims of such circumstances were women born in the 1950s. They have already been punished financially by the Government’s robbing them of their pensions.
On 24 June 2021, a Minister attended a meeting to listen to those on the patient reference group sharing their experiences of the harm that they suffered. The group also shared the harrowing and distressing experience of their families, which elicited only platitudes from that Minister. The group were advised that litigation was the right way to obtain redress, even though that Minister was fully aware of the cost implications of funding legal action against the Government, whose regulators were responsible for the avoidable harm to those families. The immediate response from that Minister regarding litigation confirmed that she obviously had not listened, as there was neither empathy nor acknowledgment of the dreadful effects suffered by the families.
The patient reference group also felt strongly about the high emotional strain of the few successful cases, and expressed anger about the trauma that individuals and their families are forced to go through to obtain sufficient finances to survive, especially when their daily lives have already been made difficult through no fault of their own. Many expressed anger and insult about public money being repeatedly mentioned as a barrier to redress, and used the term “guilt trip” in response. Many members of the group also felt patronised. Group members clarified that an independent redress agency would provide a place for harmed individuals to recoup the costs incurred by medical failings, and felt strongly that not having a redress agency is “a massive failing” by the Government.
The patient reference group was set up to gather and understand the views of the people most affected, but the Government have clearly not listened. Ministers advising litigation to obtain redress is a disgrace that shames this Government. They fail to accept, or even acknowledge, any moral responsibility for any failings. Immeasurable damage has been done to the individuals and families who have been failed by successive Governments’ lack of action and failure to prevent harm. The Government’s approach has been nothing less than reprehensible and a national disgrace. Setting up an independent redress agency is the right thing to do, and the Government should do it now, without any further delay.
Although the Cumberlege report is appropriately called “First do no harm”, the Government, medical bodies and pharmaceutical companies have not only done harm, but continue to do so by failing to address ongoing issues and the concerns of those affected. The Government now have the opportunity to right those tragic historic wrongs, and I urge them not only to implement the recommendation relating to an independent redress agency, but to implement in full and without further delay all the other outstanding recommendations in the Cumberlege report.
I pay tribute to Baroness Cumberlege and her team for producing the “First do no harm” report, and to Mrs Marie Lyon, the chair of the Association for Children Damaged by Hormone Pregnancy Tests and vice-chair of the patient reference group, for campaigning tirelessly for over 40 years for justice for the Primodos children and families. I also pay tribute to the hon. Member for Bolton South East (Yasmin Qureshi) for her exceptional support for the campaign, as chair of the APPG on hormone pregnancy tests, and to all others who have been involved in campaigning for justice, representation and support for those tragically affected by the consequences of vaginal mesh implants, sodium valproate and Primodos.
It is a huge pleasure to speak in this debate. I extend my congratulations to my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) on opening the debate in an incredibly sensitive and thoughtful way. I hope that I can follow his lead and not get angry at the Minister. I do not blame her for this, and I know that she has a very real and personal commitment to the women’s health strategy, which we will see come forward in the spring—I was grilling special advisers on that only this morning. However, I urge her to listen carefully to the voices she has heard today, and to recognise that Members of Parliament speak up on behalf of their own constituents. We hear in our surgeries, week in and week out, about the issues that are affecting women and impacting their wellbeing and health. I urge her to ensure that those voices are listened to ahead of the final strategy being published.
We have heard it all today: sodium valproate; Primodos; mesh. I always hear “the victims of mesh”, and I absolutely regard them as that; they are victims of a surgical process that has left them in absolute agony. Each of us here this afternoon has a different perspective and interest. It is absolutely right that we all have highlighted the particular areas of concern to us.
Of course, I have victims of mesh living in my constituency. I also have a wonderful family whose daughter has been the victim of Primodos. Her story is one that always resonated with me, because she is exactly the same age as I am, and has been living with her disabilities since 1972. However, I really want to talk about sodium valproate. I do not know why that issue stuck with me so clearly, other than the fact that it was through the contribution of two amazing women—Emma Murphy and Janet Williams—who came to see me when I was a very newly-elected MP, and spoke to me about valproate. I am not an evangelist for banning the use of valproate—it is such an important drug, and has a valuable impact on those patients with epilepsy who need it to support them and manage their conditions well—but it is imperative to recognise that the dangers of valproate were known for many decades but not articulated to those women who were taking it and were of child-bearing age.
We have, for decades, had really effective pregnancy prevention programmes for various drugs. I always highlight—as my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) pointed out, we have been here before—the use of Roaccutane, which I remember taking probably 30 years ago. I had to sign all sorts of bits of paper promising not to get pregnant. Then, when my daughter was prescribed it as an 11-year-old, she had to have a pregnancy test every single month— at 11—to demonstrate that she was not pregnant and that it was therefore safe to give her the drug. The same measures were not put in place for valproate.
Emma and Janet went digging around in archives; they have made endless freedom of information requests, and they have had their work recognised by the World Health Organisation. The pressure that they put on Members to convey the importance of a proper investigation to people like my right hon. Friend the Member for Maidenhead (Mrs May) brought forward the Cumberlege report, which was so valuable.
I will give a bit of a timeline: on 8 July 2020 that report was published; on 9 July, I was in the House for the oral statement on the Cumberlege report. I can remember my hon. Friend the Minister’s predecessor, the then Minister of State at the Department for Health and Social Care, my right hon. Friend the Member for Mid Bedfordshire (Ms Dorries), actually giving us hope and confidence.
I listened to her, that day in the House, and thought that she had the tone of her response absolutely right. She promised to take away the issues that we were all raising. She promised to look at all of the recommendations that the Baroness had brought forward so competently and effectively. I had hope, as did the campaigning women from In-FACT, and the hon. Member for Bolton South East (Yasmin Qureshi), who is on the APPG. We all had hope that the recommendations would be accepted and acted on with speed.
Then, on 21 July 2021, a whole year later, rather than having an oral statement in the House, when we could ask the Minister what was going to happen, and what action was going to be taken on the recommendations, the Government snuck out a written ministerial statement on the last day before recess so we had no opportunity to bring forward the concerns that we had on so many of the recommendations either being rejected or only accepted in part. Those campaigners felt despair—not the hope that they had a year before, but despair.
The third date that I want to highlight—this is where I will provide some air cover to the Minister—is 15 September 2021. Rarely in a Member’s career does the opportunity come along to ask question No. 1 at Prime Minister’s questions, and on 15 September is was my turn. It will probably never happen to me again, so I carefully considered what issue to raise. We all have brilliant constituency issues that we want to raise or things that we have been campaigning on, and suddenly, in a Zoom call with Emma Murphy and Janet Williams, I went, “Do you know what? I have question No. 1 on Wednesday.”
I used my question to ask the Prime Minister about the specific issue facing the parents of children impacted by foetal valproate syndrome: their children have learning difficulties and additional needs. Some are born with spina bifida, a cleft palate, heart defects or limb malformations. They have all sorts of additional challenges, which are expensive. They need redress and specialist centres where their children can get the support they need, to lead as full a life as possible. Guess what? Their parents also need respite. They need be confident that their children are being properly looked after, cared for, supported and helped to counteract all the challenges they face, and they need a break, but they have been offered none of those things.
So, in September 2021 I asked my right hon. Friend the Prime Minister if he would recognise that there was an additional cost—a fiscal impact—on these families and if would he commit to making redress available. He responded by indicating that the Government was
“committed to making rapid progress”—
I emphasise the word rapid—
“in addressing all the areas that”
the Cumberlege report
“mentions, including the one that my right hon. Friend covered today.”—[Official Report, 15 September 2021; Vol. 700, c. 964.]
Yet we are still waiting for redress and for the specialist centres, and the families are waiting for an acknowledgment that they face additional costs, day in, day out, and they want help with them.
I want to ask a specific question of the Minister, which was provoked in my mind by my right hon. Friend the Member for New Forest East (Dr Lewis), who sadly cannot be with us for the conclusion of this debate. He made the point about disability and the women who have had mesh implants whose ability to work is impacted forever. I remember being a Minister at the Department for Work and Pensions. We did a lot of work around people who had long-term conditions and whether they should have to go through the reassessment process.
This would be an excellent opportunity for my hon. Friend the Minister to outline to us what work she is doing with the DWP to ensure that these women can be included in that group, so that they do not have to go through endless reassessments time and again to establish whether they are still suffering pain from mesh. That is an important point, because that would give them a sense that we are making some sort of progress. That is my specific question for the Minister, which I hope she will be able to answer.
I will not take credit for my final, really important point, which should be given to my right hon. Friend the Member for Elmet and Rothwell, who passed me a note midway through the debate. We have to make sure that this stops. We must not continue to ignore the voices of women who say they had a procedure that has damaged them, but who are told it is a mental problem and it is all in their head. We cannot have a situation where people continue to be ignored, or where drugs come on to the market and are left in use and circulation for decades, before somebody recognises that there is a problem. If we go back to thalidomide and valproate, it was decades before people recognised that there was an issue.
The point was made earlier that the aircraft and airlines industry has a no-blame, no-consequence reporting system for errors, so that if someone finds something that is wrong, it will not come back on them in their career. As my right hon. Friend said, the career of the doctor who discovered the problem with Primodos was impacted by that discovery, for the rest of her career. We cannot have that situation. Just as the airline industry has a no-blame reporting system, can we also have that in our NHS, so that people have the confidence to report, knowing it will not come back upon them? Then we will not have medicines and devices that do harm, in the same way that we no longer have planes that simply drop out of the air.
It is a pleasure to serve under your chairmanship, Sir Graham, and to follow the right hon. Member for Romsey and Southampton North (Caroline Nokes). She summed up so well the concerns and the frustration that so many of us have. I pay tribute to my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke)—I call him that because we have worked so closely on so many of these issues. He spoke with such passion and in such detail about all these issues: about the impact on women and their families from mesh, from sodium valproate and from Primodos, which is what I will focus on while summing up the debate on behalf of the SNP.
My constituent Wilma Ord and her daughter Kirsteen were the very first constituents who came to see me after I was elected in 2015. I cannot believe that I am standing here today, alongside colleagues who were elected at various times, having challenged the Government and asked for action in 2015, in 2016, in 2017, and so on and so forth; for my part, I have been challenging them through three elections now.
As I said earlier, we have marched campaigners and victims to the top of the hill and put them through the trauma and frustration of the expert working group, which the right hon. Member for Hemel Hempstead (Sir Mike Penning) so poignantly discussed. I remember going over the road to the conference centre with the hon. Member for Bolton South East (Yasmin Qureshi) to challenge the expert working group, which was essentially a whitewash and a big fat waste of public money.
We do not want the incredible work of Baroness Cumberlege to be another waste of public money, and it is clear that it is not. All her recommendations are so important. An article in The BMJ in 2020 highlighted that the Cumberlege review exposed
“stubborn and dangerous flaws in healthcare”
and a healthcare system that is
“disjointed, siloed, unresponsive, and defensive.”
We must recognise the incredible work that the NHS does, but where there are flaws and where harm has been done, that must be fixed. Some things have struck me in particular about culture and harm, the litigious nature that I think has developed within some elements of the Government, and the unwillingness just to accept when wrong has been done and to see the human cost of it. The human cost to my constituent Wilma Ord and her daughter Kirsteen is just incredible, as it is to campaigners such as Marie Lyon, who has been campaigning for 40 years. She has spent four decades dedicating her life to the campaign, but she has not seen any progress other than these reviews and reports. Those are very important, but she has not seen justice and she has not seen change.
Members from across the House have mentioned the Government’s statement that there is no need for a redress agency because they have the levers and the tools. This is somewhat of a tangent, and we know that such cases are very rare, but a constituent came to me recently about the impact on them of one of the covid vaccinations. I commend the Government for putting in place redress for those who have been impacted, but I found out recently from answers to my written questions that that system has not yet paid out anything to anybody. That is proof that while there may be good ideas, they are not being followed through. A redress agency is crucial to ensuring that we make improvements and that our constituents’ lives are not damaged and dogged by such profound issues.
My constituent Wilma Ord’s medical records have a gap between 27 November 1968 and 27 January 1971, but we know that she was pregnant because she gave birth to a baby, Kirsteen, who was born with cerebral palsy and suffers from deafness. Wilma is not alone among woman who were pregnant at the time in having suspiciously missing GP records. That is a mystery that many women have had to face, and I have seen written evidence to prove it. A document dated 13 March 1964 clearly states that GPs who were worried about adverse reactions would be best to destroy any evidence of records to protect themselves, and I quote, “however wrong” that may be. Schering, the drug company that is now Bayer, sought legal advice way back when it was told it would more than likely be found guilty of negligence by a trial judge.
Marie Lyon and others have had access to these documents, as has Baroness Cumberlege, who recommended that the families who suffered avoidable harm ought to be given redress because there is a strong ethical responsibility to do so. We have heard time and again from Members across the political spectrum how important that redress is. It is surely the first and last duty of a Government to look after their citizens and, where harm has been done, to find redress and do everything in their power to make sure that harm is not done in future.
My constituent Wilma Ord has often said to me that someone who did this or has the power to affect change should walk a day in her shoes, feeling and seeing what it is like for her daughter to be unable to live a normal life. She has had a job but was bullied for being different, and no efforts were made to accommodate her deafness. I would like to think that the world and our society has moved on significantly, but Wilma feels very strongly and has expressed to me directly that it was her fault. It is important that we send a clear message today to all the victims of sodium valproate, mesh and Primodos that it was not their fault and that they are not responsible.
The right hon. Member for Maidenhead (Mrs May) spoke about the culture that still exists within healthcare today. It discriminates against women and makes them feel as if they are imagining things. It is literally gaslighting them. The wait for redress has gone on far too long. Members have spoken so passionately today, but how often are we going to have to debate these issues over and over again before the Government simply accept the recommendations and put them in place?
Mention has been made of the legislation passed in Scotland. The hon. Member for Chesham and Amersham (Sarah Green) did not feel that it had gone quite far enough, but I hope that it has gone some way to redress. We have appointed a patient safety commissioner. We are also quite well on with our women’s health plan. I say this not to in any way bash the UK Government; we are doing very similar work. We might be a bit further ahead, but I hope that our Government and the UK Government can work together on this, because I think many learnings can be shared.
Members have said that it is not the Minister’s fault—that she is just doing her duty in delivering the lines of Government—but please listen to us. Please listen to our constituents’ concerns. Do not make them wait for more decades. Let us try to draw a line under a culture that puts the desires and views of lawyers before people’s lives. That is what we are talking about. My constituent and other victims of Primodos were used as human guinea pigs. That is not acceptable. We need to send them the strong message that we stand with them, but we need every Government across the UK to do everything they can to see redress and to see the Cumberlege report implemented in full, so that victims can be at peace and have the redress that they deserve.
It is a pleasure to serve under your chairmanship, Sir Graham. I pay tribute to the right hon. Member for Elmet and Rothwell (Alec Shelbrooke) for securing this important debate and for his continued campaigning on women’s issues. We have heard today harrowing accounts of women’s experiences. It is really important that we hear those accounts and that they are repeated over and again, because we need to remind ourselves that these are real human beings who have to live with this day in, day out. It is important that we record that in this House.
I thank right hon. and hon. Members for their powerful contributions to the debate. As a fairly new Member—I believe I am the newest Member in the Chamber—and having taken some time off for maternity, I have spent less time here than most Members present, so this is the first time that I am hearing about the progress that has been made on the Cumberlege review. It is really depressing to hear that we have not made much progress on the recommendations.
The pressing thread throughout the debate has been the patronising attitude to women’s voices, as was mentioned by the right hon. Member for Maidenhead (Mrs May), which continues. I take this opportunity to pay tribute to campaigners for their tireless work around the Cumberlege review—particularly the Association for Children Damaged by Hormone Pregnancy Tests, without which the review would have never taken place and we would not be here today.
We have heard that Baroness Cumberlege’s excellent review looked into the use of Primodos, the use of sodium valproate during pregnancy, and the use of pelvic mesh implants. Those medicines and medical devices have caused untold physical, developmental and emotional harm to tens of thousands of women. It is almost four years since the independent medicines and medical devices safety review was announced, but it is over 50 years since these treatments started to be used and, as has just been mentioned, women have been trying to get their voices heard for decades.
The hon. Lady may be new to the House, but she is doing very well in trying to understand the position. In the case of Primodos, that was not a drug that was going to cure anything; it was simply a tablet that told the person who took it whether they were pregnant. There were other methodologies around at the time that were deemed to be safe, but GPs continued to give out Primodos when they knew it was not safe. It is quite a clear, difficult thing: GPs were giving out a drug years after the relevant bodies said it should not be given.
I totally agree with the right hon. Gentleman. I am the mother of an eight-month-old, and during my pregnancy I trusted my GPs and everything they said. I was vulnerable, like all mothers, and I believed that they wanted the best for me. It is absolutely devastating that GPs knew the impact of these drugs yet continued to give them out to women. I thank the right hon. Gentleman for that contribution.
I have constituents in Enfield North who were impacted on by these medicines. My constituent Chris was given Primodos in June 1970 to find out whether she was pregnant. Her daughter Emma is now 51 years old and has suffered throughout her life from limb deformation, spinal problems, scoliosis, joint problems and mental health problems. She lives in chronic and intense pain that does not go away, and she can no longer work full time.
The review set out nine ways in which the Government could have delivered justice, made the lives of those affected—such as Chris and Emma—a little easier, and tried to prevent future incidents. Given the shocking accounts that we have heard today—accounts that the Government have been hearing for years—and the evidence in the review, one would have expected the recommendations to be accepted in full, but that is not the case. As we have heard, the Government have accepted four recommendations, but there are two that they have not accepted. They have accepted two other recommendations in part, and one in principle.
I am pleased that there has been an apology and that there is legislation for a patient safety commissioner. I am pleased that there are specialist centres for the care of those with complications from mesh implants, although I hope the Minister will address the serious concerns we have heard about that. I am also pleased about the changes to how doctors’ conflicts of interest are reported.
However, that is not why we are here today. Implementing those recommendations alone is not good enough. The Government have refused to establish a redress agency for those harmed by such medicines and medical devices, or to set up a separate scheme to meet the costs of providing additional care and support to those who have experienced avoidable harm, which would make a huge difference to families in meeting their exceptionally challenging needs every day. My constituent Emma worries about her ability to keep working and her financial stability. If a scheme were available to support her financially, she would not have to worry.
The Government claim to care about women’s health and making a change. Their vision for women’s health, announced in December, is
“to improve the way in which the health and care system listens to women, and to reset our approach to women’s health by placing women’s voices at the centre of this work.”
They then directly cited Baroness Cumberlege’s review, stating:
“Independent reports and inquiries—not least the report of the Independent Medicines and Medical Devices Safety Review…have found that it is often women whom the healthcare system fails to keep safe and to whom the system fails to listen.”
The Government accept the review and use it, but will not deliver on it. They will not truly listen to those who have been campaigning for justice for years and do right by the families. They will not take the opportunity to reset their approach to women’s health and place women’s voices at the centre of their work by implementing all the recommendations.
In November, I wrote to the Secretary of State for Health and Social Care to ask him to consider establishing a taskforce to implement all the recommendations of the review to put these injustices right. I am still waiting for a response. How can the Government claim that they are taking the review and women’s health seriously if they cannot even respond to a letter from a Member?
Will the Minister please commit to implementing the remaining recommendations? If not, will she explain how not implementing the full recommendations of the Cumberlege review changes anything, or helps to create a system that keeps women safe and listens to them? It is time for her to stand up for the families affected by Primodos, sodium valproate and surgical mesh, and for the Government to stand by their vision by implementing the recommendations in full. Otherwise, we will fail these families and these women again and again.
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.
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.
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.
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?
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.
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.
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.
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.
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.
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.
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.
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.
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?
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?
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.
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.
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.
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.
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.
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.
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.
I thank all hon. Members who have contributed this afternoon. Even though many Members have given me apologies for not being able to be present, we have covered the wide-ranging aspects of the review concerning Primodos, sodium valproate and mesh. I thank and congratulate the Minister, who showed in her response that she understands her brief. I will come on to some of the issues we disagree on, but she did not just read out what has been written for her. She has taken the issue seriously and has taken the debate on board. That is a refreshing change from her predecessor.
Let me move on to some of the specific comments. I welcome the hon. Member for Chesham and Amersham (Sarah Green), with whom I have not had the privilege of being in a debate before. She made an important point when she said that we need to listen to victims. That is the point of the report: the need to listen to victims. We have to be very careful about how we proceed. The report was trusted because the victims felt that they were finally and properly listened to. That is why it matters so much.
Let us be blunt: it does not matter which side we are on, we in this place are all getting a bit of a bad press at the moment. The report is an opportunity to show people that they can have faith in this place and trust it. When we go out, listen to victims, take their views on board and, as a Parliament, say, “The adversarial side of politics can be parked over there, because on these really important issues, we all get together and we can make things happen,” we can do things. I thank the Minister for the progress that she is making on the recommendations, and for giving us the update.
The hon. Member for Livingston (Hannah Bardell) gave us a shocking revelation. Records were destroyed, rather than people admitting the mistakes that had been made. That is why redress, the databases and all the other things that we want to introduce are so important.
We come back to this point. I thank my right hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) for her reference to the analogy I gave her about the aircraft industry. The Minister used the word “whistleblower”, and that is the wrong word. We are talking about cultural change, and it follows on from what the hon. Member for Livingston and my right hon. Friend the Member for Romsey and Southampton North said. We have to develop a culture in which it is natural for anybody working in a system to feed in, “This is going wrong” or “There has been some evidence of this.” There should be no blame for anybody and no comeback for their careers.
I am a great fan of the TV programme “Air Crash Investigation”—my wife cannot watch it—especially as I spend my life in the air. It is absolutely clear when people watch that programme how the airline industry is now at a point at which it is really unusual for a plane to drop out of the air, because of the no-blame culture. If somebody leaves a spanner somewhere, that gets reported. The tiniest things are reported, which is how that industry’s safety has improved.
Thank you, Sir Graham. The most important point that I want the Minister to take away today is the following. I do not want compensation for people; it is not compensation that I am seeking. I want there to be grants, like the thalidomide grant. People will be subject to these injuries for life, and compensation is not going to cover it. We have a responsibility to deal with the problem, so I hope that my hon. Friend takes that away today. I say this to the Minister: we will keep coming back and keep coming back, and eventually there will be a votable motion on the subject on the Floor of the House and I do not think it will be able to be whipped.
Question put and agreed to.
That this House has considered the matter of implementation of the recommendations of the Cumberlege Report.