Independent Medicines and Medical Devices Safety Review

I beg to move,

That this House notes the publication of the Independent Medicines and Medical Devices Safety Review, First Do No Harm; further notes the Government’s failure to respond to the recommendations of that review in full; notes the significant discrepancy between the incidence of complication following mesh surgery in the Hospital Episode Statistics and the British Society of Urogynaecology databases, as highlighted in the Royal College of Obstetricians and Gynaecologists’ Project Report, entitled Hospital Episode Statistics as a Source of Information on Safety and Quality in Gynaecology to Support Revalidation; notes that the Government’s plan to publish a retrospective audit to investigate the links between patient-level data to explore outcomes has not been fulfilled; notes that the moratorium on mesh implant procedures should not be lifted until that audit has been undertaken and the true scale of suffering established; notes Ministers’ failure to acknowledge recommendations relating to victims of Primodos; and calls on the Government to fully implement the recommendations for victims of mesh, sodium valproate and Primodos without further delay.

I thank the Backbench Business Committee for allowing this debate. Today is the one-year anniversary of the publication of the report of the independent medicines and medical devices safety review, entitled “First Do No Harm”. It is that report, and the Government’s response to its nine recommendations, that this debate is intended to address. I would like to take this opportunity to thank Baroness Cumberlege, who chaired the review, and her dedicated team. I am delighted that she is able to be here to listen to the debate.

The publication of the report gave hope to so many women who had felt ignored and belittled for years. Since it was published, Baroness Cumberlege has continued to campaign in the other place for the thousands and thousands of women impacted, and I am proud to be supporting her. I pay tribute to the women personally affected by the medical interventions under investigation and their bravery in sharing their stories. In the words of the report,

“They told their stories with dignity and eloquence, but also with sadness and anger, to highlight common and compelling themes.”

The review examined the hormone pregnancy test Primodos, which was thought to be associated with birth defects and miscarriages; sodium valproate, an effective anti-epileptic drug, which caused physical malformations, autism and developmental delay; and pelvic mesh implants, which have been linked to crippling, life-changing complications. The report had a damning conclusion:

“the system is not safe enough for those taking medications in pregnancy or being treated using new devices and techniques”.

I thank the hon. Lady for securing this debate. I do not intend to speak, but I am here today because a constituent has written to me. She has suffered horribly from appalling damage as a result of these procedures. I want to thank the hon. Lady sincerely for bringing this to the Floor of the House and allowing us all to be educated—well, those who need educating, like me.

I thank the hon. Gentleman very much for his comments, and I am very pleased that he is able to join the debate.

The report showed that patients were exposed to the risk of harm when they did not need to be. They were affected adversely by poor or indifferent care. They suffered at the hands of clinicians who did not listen or chose not to do so. They were abandoned by a system that failed to recognise its mistakes and correct them at the earliest opportunity.

The systematic silencing of women’s voices, the indifference to their stories and the outright denial of their pain and suffering was a central theme in the findings of the report. That theme has been repeated time and time again when it comes to women’s health. Enough is enough. Today’s motion calls on the Government to implement all nine of the recommendations in the report, and I hope Members across the House will support it.

I am joint chair of the all-party parliamentary group on surgical mesh implants, and my comments will obviously focus predominantly on that, but I want to very quickly mention the Epilepsy Society’s campaign “Safe Mum, Safe Baby”, which calls on the Government to fund research into safer epilepsy medication so that babies are not born with preventable diseases.

The hon. Lady is right to bring this issue to the fore, and I commend her for that. The Minister will recall that I had a debate on how the mesh is affecting men. I had 400 people in Northern Ireland contact me saying that their problems were the same: it is hard to remove and causes extreme pain, depression, relationship problems, marriage breakdowns and, for some people, unfortunately suicide. Does the hon. Lady agree that, whether the mesh is for women or men, it is detrimental and has harmed many people?

Absolutely. One of the points that I will come to later is that people who have had rectopexy and hernia mesh implants have also been badly affected.

The recommendation that I want to focus on is the one that requires immediate action from the Secretary of State to set up an implementation taskforce to oversee the progress of the other eight recommendations, and to offer a timeline for the actions. Unfortunately, the Government declined the recommendation and instead offered the creation of a patient reference group to

“ensure that patients voices are heard”.

With respect, patients’ voices have been heard in the Cumberlege report. We already know that women are not listened to in the healthcare system. We need action to change that, rather than another review kicking the can down the road. I would be interested in hearing from the Minister how the Government intend to ensure that women’s voices are placed at the centre of their treatment when the patient reference group publishes its report.

Like others, I thank the hon. Lady for securing this vital debate. Does she agree with me that we need to encourage women to speak up and to support them to deal with their own health issues, but that comments made by some in Government recently that it is down to women individually to speak up can be unhelpful? We have to see this through the lens of the institutional challenges that women have faced for decades. Although we need to celebrate our clinicians, we really need to do more to educate them and give them resources and support to ensure women are not treated in the way the hon. Lady is describing.

I thank the hon. Lady for her intervention and I agree with her absolutely, which brings me on to the point about the redress agency, which is one of the recommendations in the report that has been rejected. Instead, the Government have said:

“The government and industry have previously established redress schemes without the need for an additional agency.”

That goes to the point that she made, because this puts the burden of redress in entirely the wrong place: on the victims, not on those responsible. Seeking redress requires enormous effort on the part of those who are already suffering, not just financially but emotionally, as was set out in Baroness Cumberlege’s report. It recommends that without waiting for the establishment of a redress agency:

“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”.

Sadly, no such moves have been made, so I would be interested if the Minister gave an indication of the progress on such schemes.

The report also recommends transparency on payments to clinicians, with a UK-style Physician Payments Sunshine Act 2010 to require the mandatory reporting of all payments made to doctors, teaching hospitals, research institutions and charities. The Government’s interim response said that they would “consider” this recommendation, in discussion with other parties, including the General Medical Council. I understand that there are suggestions that this could be done by expanding the voluntary system of reporting, but, as we have seen, voluntary systems simply do not work.

By way of a quick example, a high-profile academic recently admitted that he had failed to declare £100,000 from the manufacturer of one of the types of vaginal mesh implants that he was assessing. He has now published a correction, but this is almost seven years after he first did his report and it came only after a complaint was made about him. A section 60 order in the Health and Care Bill would allow for legislation to cover this, because transparency is vital to patient safety. There should be no opportunities for payments made by industry to introduce bias into prescribing or the scientific literature that is used to inform our National Institute for Health and Care Excellence guidelines. This report recommended creating a database to record which device was used when, in which person, and what the outcomes were in terms of safety and patient feedback.

I am grateful to the hon. Lady for joining me to help to secure this debate. I will be speaking later, but I wanted to touch on this specific point about the pressure we are coming under. Does she agree that nothing has changed from a clinical point of view in the past 18 months, yet the clinician pressure is to stop the suspension? Does that not represent the pressure we are under coming from the clinician side of this argument?

I completely agree and thank the right hon. Gentleman for bringing this debate forward and championing it from the other side of the House. He correctly says that we need to have all that evidence so that people can give that informed consent.

Finally, the report recommends establishing specialist treatment centres

“to provide comprehensive treatment, care and advice”.

Some of these care centres are being established, which is good news, but again there are concerns about the data collection on patient outcomes after mesh removal and not all women are having all their mesh removed—some of this is only a partial removal. Again, what questions are being asked and what data is being collected? I have submitted numerous written parliamentary questions to the Department but have yet to receive a clear answer on exactly what data will be collected.

There are also important questions to be answered on the competence of surgeons to undertake removals. I know that my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson) has a very difficult story on this issue. The Department says that it is for individual trusts to decide which surgeons to use for removals, but I do not share that view. How can it be fair to ask a woman to return to the same surgeon who put the mesh in, causing her all that harm, in order to have it removed? I really think we need to look at this issue again.

The situation is even worse than the hon. Lady suggests, because in some cases these surgeons, who have now been appointed as lead figures in the mesh centres, are the people who not only put the mesh in but then persisted in denying that the mesh was the cause of any of the terrible problems their victims had suffered.

I thank the right hon. Gentleman and completely agree with his point.

We are now one year on from publication of the Cumberlege review. Of course I accept that there has been a pandemic, but there is nothing to stop the Government accepting the recommendations. We would all be quite realistic and understand that the Government can accept the recommendations but that there would have to be a delay in implementing them, because of the pandemic. That would be fine, but they have not. They have implemented only two recommendations, on an apology and on the appointment of a patient safety commissioner.

Given the lack of progress and the concerns that I have outlined, to which I know colleagues here will add further, I urge the Government to reconsider the implementation taskforce. The problems identified by the review are systemic and of long standing and, if unaddressed, will condemn more to a lifetime of suffering. It is essential that they are brought to an end, and to do so the review’s recommendations must all be implemented in full.

I join the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) in thanking the Backbench Business Committee for enabling this important debate.

I decided that the independent medicines and medical devices safety review should be set up because I was deeply concerned about the impact, which had been raised over many years, of the use of certain medicines and medical devices on women, and in particular the use of pelvic mesh, sodium valproate and hormone pregnancy tests, predominantly Primodos.

I would like to take this opportunity to commend all Members of the House who have campaigned on these issues over the years. I would also like to add my thanks to the noble Baroness Cumberlege for the work she did in chairing the review, and in producing such a no-holds-barred and absolutely-to-the-point review, which made very clear for the Government the problems that had occurred and what needed to be done.

I will also take this opportunity to say to the Minister that I would like to thank the Government for their decision to establish a strategy for women’s health, which I think is important. But that is for the future; what we are talking about now, of course, are problems that occurred in the past but also problems that are still occurring, as we have just heard in relation to mesh, and indeed as with sodium valproate, which I will refer to later.

What was clear to me when these issues were raised with me is that over decades women had suffered, children had suffered and families had suffered, and the impacts are still being felt today. What was also clear was that the voices of patients, of women and of others had been raised and had consistently been ignored. There had been a sort of attitude that said, “There, there. You’re a woman; you just have to put up with it.” The unwillingness to listen and act had occurred under successive Governments, through the Department of Health and various aspects of the national health service.

I have to say to the Minister that sadly such an approach is perhaps not unexpected by Members of the House. I am sure that other Members will, like me, have had constituency cases in which there has been a problem with the treatment an individual received from the NHS, and they want an apology and to know that someone will ensure that it does not happen again to somebody else, but they come up against a brick wall, because the natural inclination is to defend the institution, rather than address the issue that has been raised.

Some of the ladies in Northern Ireland who have contacted me want more than apologies. Some of them have not been able to work—they cannot work and will never be able to work—not because of anxiety and depression but because of the physical difficulties they have. Does the right hon. Lady agree that this is also about making sure that people have the benefits that the Government can make available? We also need to address the breakdown in their marriages and the help we can give. Those are some of the things that my constituents want to see, as well the things that the right hon. Lady has referred to.

The hon. Gentleman is absolutely right and I shall come to the issue of redress in relation to these particular aspects of pelvic mesh, sodium valproate and Primodos and other HPTs. I was making the general point that I see constituency cases of individuals where a mistake has been made by the NHS. They want an apology and to know that change is going to take place, but they come up against a brick wall and sometimes find themselves battling and ending up in court to try to get some redress—with all the problems that that creates—because the institution has defended itself, rather than taking the patient’s voice seriously.

Our NHS does amazing work day by day and it has done amazing work during the pandemic, but, sadly, when mistakes are made, it does not always respond in the right way. The report of the independent review made this very clear:

“There is an institutional and professional resistance to changing practice even in the face of mounting safety concerns. There can be a culture of dismissive and arrogant attitudes that only serve to intimidate and confuse. For women there is an added dimension—the widespread and wholly unacceptable labelling of so many symptoms as ‘normal’ and attributable to ‘women’s problems’.”

It went on:

“Mistakes are perpetuated through a culture of denial, a resistance to no-blame learning, and an absence of overall effective accountability.”

It was apt that the report was called “First Do No Harm”; as the noble Baroness Cumberlege said:

“It is a phrase that should serve as a guiding principle, and the starting point, not only for doctors but for all the other component parts of our healthcare system. Too often, we believe it has not.”

Like the hon. Member for Kingston upon Hull West and Hessle, I am concerned that the Government have not responded to and accepted the recommendations of the review in full. The recommendations were not made lightly; they were made after listening to considerable evidence and hearing the voice of people who had suffered for years as a result of the use of these medicines or medical devices. The report identified where changes needed to be made. Of course responses take time and of course the Department has been dealing with the pandemic, but I hope that the Government are going to respond properly on all the issues raised.

The right hon. Lady has made the point about institutional cultures, defensiveness and the culture of litigation that it feels like we have now got into, particularly in respect of some aspects of the health service. Does she agree that the patient safety commissioner must have teeth and must be able to help us—I think there would be agreement across this House and in the other place on this—to try to move away from that culture so that we can learn from mistakes?

I absolutely agree about the importance of the patient safety commissioner; they have to be able to do the job that is intended and set out for them to do. I know that there will be those who will be concerned that their sponsoring Department is the Department of Health and Social Care. It is natural because this is a health issue, but I hope that the Department will make every effort to ensure that it cannot be accused of trying to water down the role of the independent safety commissioner, because, as we are saying, it is important for the user’s experience to be heard. This is not about trying to get at the Department of Health or the NHS or anything. It is about people who are suffering real-life experiences and impacts as a result of the use of medicines and medical devices; it is about identifying those situations and ensuring that action is taken to stop them happening so that others can be protected.

The issue of redress was mentioned by the hon. Member for Kingston upon Hull West and Hessle and the hon. Member for—I apologise, because the hon. Gentleman is in the House so frequently, but I have forgotten his constituency—[Interruption.] Strangford, thank you. The issue was also mentioned by the hon. Member for Strangford (Jim Shannon). The Government have said that an agency is not needed, yet time and again the only redress for patients is through recourse to the courts. That is expensive and stressful. It is also expensive for the national health service; in 2018-19, the NHS paid £2.4 billion in clinical negligence claims. But redress is about far more than compensation. It is about relating to the real impact that the use of these medicines and medical devices has had on people, such as the need for special education for children who have been affected because their mothers have taken sodium valproate when pregnant. There are many other examples. I urge the Government to look again at that issue.

I also want to raise the issue of the patient’s voice, because this has all been about an unwillingness in the past to listen to the patient’s voice. Setting up the patient reference group was fine, but I understand that it is due to publish findings shortly, and nobody knows whether the patient’s voice is going to be taken into account or how it can be in the future. I urge the Government to ensure that patients are part of the implementation; it is their experience that we are talking about, so it is so important that they are included.

I thank my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) and the right hon. Member for Elmet and Rothwell (Alec Shelbrooke) for securing this very important debate. As we have heard, today marks one year since the independent medicines and medical devices safety review was published. I was speaking virtually that day and I have to say that I am thrilled to be able to speak in the Chamber today; thankfully, it is starting to feel a bit more normal. I wholeheartedly thank Baroness Cumberlege and her team for their excellent work; it is great to see her with us today. I also thank the right hon. Member for Maidenhead (Mrs May) for commissioning the review in the first place. It was a brave and bold thing to do—and the right thing to do, as she has so often done in this place.

The problems with the medicines and medical devices that the review reports on—Primodos, valproate and vaginal mesh—have been ongoing for much, much longer than just the past year, as we all know. I have had the privilege of working with campaigners over many years on these issues; I pay tribute to Janet Williams, Emma Murphy, Marie Lyon and Kath Sansom, to name just four, for their dedication and expertise. They are normally with us for these debates, and it is sad that they are not able to be here.

I first spoke in this House about surgical mesh implants in October 2017, as shadow Minister for public health—there were always lots of debates in that brief, as my hon. Friend the Member for Nottingham North (Alex Norris) will know. My mam always likes to see my speeches, so one Saturday, while I was making lunch, I showed her that speech and said “Oh, thank goodness you’ve never had any of this awful mesh put in.”

That was when our world was turned upside down. She said, “No, no, I only had a bit of tape put in a few years ago, before all my troubles started”—the “troubles” she refers to being numerous health problems that appeared one after the other. She had had scans and cameras everywhere, with no diagnosis. Obviously there was no solution that could be found. Does that sound familiar to those who have had constituents with mesh problems get in touch?

I am most grateful to the hon. Lady; I really appreciate all the work that she has done on the issue alongside us. To take what she says one step further—she may be coming on to this point—does she agree that the other problem is that the evidence we have had in APPG meetings is that the very same surgeons still think that this is the best cure for women? They are not actually accepting some of the problems that are blatantly obvious.

The right hon. Gentleman makes a very good point; I was not moving on to it, so I am glad he has made it. They are very keen to start reimplanting and reusing the mesh; they still say that it is great and that it transforms 90% of women’s lives. For the 90% whose body can tolerate it, that is great, but for the 10% who cannot, it devastates their lives. It transforms their lives in a devastating way; in many cases it can leave them crippled and unable to work.

Not all these women are of pensionable age like my mam, who is 76 this year. Some are still of working age and have all the problems associated with trying to get recognition in the benefits system when so little is still known, not just by GPs but by the Department for Work and Pensions people who are dealing with them. The last thing we want to do is create more victims of this terrible medical device. Mesh-injured women are between a rock and a hard place: either they have their mesh removed by the very same surgeon who implemented the mesh, often—in the case of my mam as well—after it was widely known that it was devastating some women’s health, or they do not have it removed at all. This should never be a choice, so I call on the Minister to work with NHS England to reconsider that and put patients first by giving them a genuine choice about where they go for their mesh removal and who removes it. There are only eight of these centres, so this is not often as easy as saying, “Oh well, you can go to Manchester or London,” as was said to my mam; obviously, I will bend over backwards to enable that to happen, but some women just will not have the wherewithal. There must be a way for surgeons from other parts of the country to travel to where those women are, so that they do not have to face and deal with the surgeon who put the mesh in them.

I want to briefly mention valproate and Primodos. Since the review was published a year ago, very sadly 10 members of the Association for Children Damaged by Hormone Pregnancy Tests have died, still suffering with the enormous guilt of feeling, even though it was not their fault, inadvertently responsible for the damage to their babies. This has been an ongoing battle for them since 1978 and we have heard and will hear further this afternoon how devastating this drug has been for those who took it in all innocence, with full trust in their doctors to do them no harm.

What an honour it is to follow the hon. Member for Washington and Sunderland West (Mrs Hodgson); I remember from my time as Health Secretary what an incredibly powerful and passionate campaigner she was on all health issues, and she has done an enormous amount for families up and down the country through her campaigning in this place. I also thank the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) for her powerful comments and for securing this debate alongside my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke); both are formidable campaigners. I also particularly thank my right hon. Friend the Member for Maidenhead (Mrs May) for encouraging me to commission this review as Health Secretary. It was the right thing to do, and it reminded me of another great decision she made: to commission an independent investigation into the contaminated blood scandal, which was long overdue and which Prime Ministers prior to her had ducked. That was again an example of someone being prepared to do the right thing.

We would not be here if it were not for the hard work and dedication of my noble Friend Baroness Cumberlege. When I asked her to carry out this review in February 2018, neither of us had any idea quite what a huge job it would be. She set about the task with enormous energy and determination, and with the integrity to know that the job could not and would not be done properly until she had heard the stories of families up and down the country who had been damaged by what went wrong. I thank her, Sir Cyril Chantler and the entire team for their work and the clarity that they have brought to these difficult issues.

There has been the most terrible oversight of women’s medicine and medical devices. Until we implement the recommendations in the report, there will not be just a lack of justice, but also a risk of repeat.

I commend the Minister, who I know is personally deeply committed to patient safety. I know that, as a Minister, it is not always easy to get your way and to do all the things that you would like to do, because other people in the system overrule you. I know her heart is in the right place. I thank her for the fact that we have legislated for a patient safety commissioner.

I am grateful for the opportunity to speak in such an important debate. I congratulate, again, the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) and it is a pleasure to follow the right hon. Member for South West Surrey (Jeremy Hunt). It is rare in these political times that this House is united on an issue, but it is united today, more than I have seen it for some time. I hope to speak directly for a moment to those out there who are watching who have been affected by hormone pregnancy drugs such as Primodos, like my constituents Kirsteen and Wilma Ord, or sodium valproate or vaginal mesh, or mesh that is used in men: this House is united and there are Members in this place who will not give up the fight to make sure that you get justice and redress.

I want to talk specifically about families affected by Primodos. I pay tribute to Baroness Cumberlege and I am very pleased that she is here today. She and her team did an incredible job on her review, “First Do No Harm”. I pay testament to the bravery, dedication and passion of the Primodos campaigners, led by Marie Lyon. She is the personification of persistence and I know that she will be watching, because it is unimaginable that families and victims of Primodos had been subjected not only to the harm of the drug, but years and years—decades—of waiting and campaigning. We have to recognise, as Members including the right hon. Member for Maidenhead (Mrs May) did, that it is so damaging that these things can take so long. They are corrosive and debilitating—I have seen that in my constituents.

Time and again, we see families treated this way, whether they are the victims of thalidomide, contaminated blood, the families of Hillsborough or now the victims of Primodos, sodium valproate and medical mesh. There have been years of inquiries and public money is being spent for those who have suffered and are still suffering, and very often, they do not get justice or have to wait for decades, or they and their family have died before they have the truth. It is a culture of kicking the can down the road and it is toxic.

One key thing, particularly in relation to Primodos, is the guilt that those women live with—that they somehow were responsible, and have been told by doctors that they were responsible, for the harm of their own child, which we all know is absolutely incorrect and not true. I hope that any family, any victim and any woman affected, particularly by Primodos or, indeed, sodium valproate or mesh, know that it is not your fault. You did not do anything wrong.

The Cumberlege review was a huge step forward in recognising the unnecessary and colossal harm inflicted on victims of the Primodos drug. The review was supposed to mean that victims had finally been heard and believed and I think that many, many felt that they had been. After it was published, the Conservative Government made a very welcome and long overdue formal apology to victims, and I pay tribute to the former Health Secretary, the right hon. Member for South West Surrey, and the former Prime Minister, the right hon. Member for Maidenhead, for their part in the work that they have done in that area.

The hon. Lady mentions the expert working group’s report, which was, as she rightly says, universally panned in this Chamber. The interesting thing is that the Cumberlege review took place after the expert working group. It had a look at the report and also came to the conclusion that it was not worth the paper it was written on.

I thank the hon. Lady for her intervention. She makes an excellent point. We know there were serious questions around the process and the independence of the report. I remember going with her across the road to the conference centre where it was being launched, and being denied entry. Two democratically elected Members of Parliament working for our constituents were refused entry to the launch of a report funded by public money. It was an absolute scandal.

The evidence uncovered by Sky News reporter Jason Farrell suggested that significant sections of the original draft were changed before publication, including the omission of a graph showing that the majority of historical studies found an association between the drug and malformations. In short, evidence was deliberately omitted and censored, and Government money was spent on that. You know the worst of it? Families and victims were strung along for months and months and months only to be let down. That can never happen again.

If the Government seek to rebuild trust after such devastating scandals as Primodos, they must give the public and most of all the victims a fair and open process. That cannot be achieved, however, if it relies on a report and findings that are not fit for purpose. Everybody in the House knows that and the public know that. How many times are we going to see public money spent on placating people, while report after review gathers dust on a shelf rather than action being taken? Processes have to be open and robust. When they are and when reports such as Baroness Cumberlege’s report are produced, they have to be put into action. It is vital that that now happens and that we find a way forward for Primodos victims, and for the victims of sodium valproate and mesh.

All the failings in the system that led to this awful situation are in the past and cannot be undone, but we have to be sure that the public have confidence not just in their medical practitioners, who have done a phenomenal job through covid, but in the processes and in our ability as parliamentarians to do our job. Now, in 2021, why are the Government continuing to perpetuate that wrong? They are compounding the pain and suffering that the families have endured at the hands of the state’s failure to regulate private pharmaceutical companies properly. It feels very much like profit over people. We do not want to hear, and I know that my constituents do not want to hear, “We’re in litigation; we’re engaged in a legal process.” That is all very well, but the Government have a duty to implement the recommendations of the report that they commissioned.

All I would say to the Minister and the Health Secretary is that they have the opportunity to right a wrong. Let us not continue down the road of defensiveness and turning our back on those victims who have waited decades—literally lifetimes—to get answers and justice. Ministers should do the right thing and give them the justice and the recompense that they deserve.

May I, too, commend the Backbench Business Committee for securing this important debate?

My constituent Mrs Jennifer Meakin was pregnant with her third child, Daniel, when she was prescribed Primodos as a pregnancy test. Daniel was born on 14 September 1974, with severe birth defects. He had an occipital swelling containing brain cells and fluid, which had leaked out when the neural tube was developing, and he was categorised as spina bifida. Daniel has undergone five major brain operations. By any standard, he is severely disabled. Equally, by any standard, the challenges experienced by the Meakin family since his birth over 47 years ago have been enormous.

Hormone pregnancy tests first came on to the market in the early 1960s, and approximately 1 million prescriptions were dispensed. As early as 1967, warnings were made available to the Committee on Safety of Drugs that such tests were unreliable, might cause neural tube defects of the sort that afflicted Daniel, and could precipitate an early abortion. However, a 1967 CSD press release reported:

“The consensus of expert opinion is that there is no scientific evidence to support the view that the hormones used in pregnancy tests can cause congenital malformations.”

The IMMDS report comments on that very forthrightly, stating:

“Given the concerns raised, the non-essential nature of HPTs and the provision of risk-free alternative tests…the CSD…should have recommended the withdrawal of the indication for use as a pregnancy test in 1967.”

However, it was not until June 1975 that a general warning was issued by the Committee on Safety of Medicines, the statutory successor to the CSD, about the possible association between hormone pregnancy tests and an increased incidence of congenital abnormalities, with an explicit recommendation that doctors should not prescribe hormonal preparations for pregnancy tests. That was some eight years after concerns about the tests were first raised and eight years after the date when, according to the report, the CSD should have recommended that Primodos should not be used as a pregnancy test—and sadly, of course, it was after Mrs Meakin was prescribed the drug for that purpose.

I thank my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) and the right hon. Member for Elmet and Rothwell (Alec Shelbrooke) for securing this important debate and the Backbench Business Committee for making it possible.

I want to talk about sodium valproate and the impact it has had on so many people, including so many children of women who were taking that drug, and I want to talk about my constituent Bethany Dodgson, a young woman affected by foetal valproate syndrome. She speaks up on this issue, and she tells me about her difficulties and the more serious difficulties experienced by her brother every day, as well as about her role as a carer in her family and how they have to live with the consequences of foetal valproate syndrome. I also want to pay tribute to Janet Williams and Emma Murphy from INFACT—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 on this issue.

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. People have campaigned, as Emma and Janet have campaigned, and they have been through records and talked to an endless number of people to try to ensure that women are made aware of the risks of taking sodium valproate, but still we see people being harmed. One year on from the Cumberlege report, “First Do No Harm”, what we have seen on this issue is one letter sent in the last few weeks to warn women of the risk. 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 from their mothers taking sodium valproate.

I would like to talk a bit, as others have, about the recommendations of Baroness Cumberlege’s report “First Do No Harm”. The first thing is the patient safety commissioner, which has been accepted. I am aware that there is movement, but still we have further delays. We have a consultation on the role, and we have extended delays. This is a really significant and important role for the future, and I would urge the Minister and the Government to act swiftly to ensure that the patient safety commissioner is in place.

I thank the Backbench Business Committee for allowing this debate in my name and that of the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy).

When the hon. Lady and I met to discuss the progress that may or may not have been made, we felt it was important to hold this debate today because it is one year since the publication of the report. Everybody in this House, and I am sure a lot of people around the country, understands that the past year has created a set of circumstances that was always going to put some aspects on the back burner and not move them forward. So today’s debate is not designed to criticise and have a go at the Government—I have a great deal of respect for the Minister and the Department—but merely to say, “Please don’t forget about this report.” It is one of the most important reports on health matters that has come before this House in many years.

What is important today is that none of us loses sight of the people we are talking about. Hon. and right hon. Members from across the House have already raised issues relating to the people themselves—real stories about real people. The hon. Member for Washington and Sunderland West (Mrs Hodgson) has done enormous amounts of work on this and speaks with passion and from the heart of the effect it had personally on her family and her mother. I can only wish her and her family the best and hope that those matters can be resolved.

This first came to my attention when a constituent came to see me. I know that some hon. and right hon. Members will have heard this story before—in fact, the hon. Member for Washington and Sunderland West touched on it—but it is worth telling again. The constituent was a very, very brave lady. She was in her 40s. She had had a child. She was a physiotherapist for the NHS. She was fit and healthy. She stood in front of me and could not sit down. She was having to bend her body into a position to feel as comfortable as she could. She sweated throughout the entire surgery because she was in crippling agony.

I wish to speak about the devastating effect that the drug Primodos had on countless families, including my constituent, Nan McGradie, and her daughter, Michelle.

The hormone pregnancy test drug Primodos was taken by women in the 1960s and 1970s to test for pregnancy. There was considerable evidence that women who took the drug prescribed by their general practitioner and were pregnant at that time gave birth to babies with serious birth defects including deformities, disabilities, missing limbs, cleft palates, brain damage and damage to internal organs, and in some cases miscarried or had stillbirths. The surviving victims of Primodos are now in their 40s and 50s and many face a host of new problems as their bodies continue to suffer. Many have died prematurely.

Despite the serious concerns raised by paediatrician Dr Isabel Gal in 1967 indicating the possible dangers of Primodos, no official warnings were issued about these drugs until eight years later. The Committee on Safety of Medicines and the Committee on Safety of Drugs were the Government drug vigilance authorities at that time. Those committees were set up specifically to ensure that nothing like the previous thalidomide tragedy could ever happen again. There is strong and compelling evidence of systematic regulatory failures demonstrating that the committees tasked with safeguarding the health of pregnant women failed in their duty of care.

I want to briefly highlight the case of my constituent Nan McGradie and her daughter Michelle. In 1975, Mrs McGradie was a recently married, healthy young woman. Feeling sick and suspecting she may be pregnant she went to her doctor for a pregnancy test expecting, as was normal at the time, to have a urine test. Instead her doctor prescribed her two Primodos tablets. It was subsequently confirmed that Mrs McGradie was about seven or eight weeks pregnant at that time—incidentally, around the time that a foetus in a womb develops a diaphragm. At the time, in 1975, Primodos had already been banned for use as a pregnancy test for five years in Norway and Sweden.

Mrs McGradie had a totally uneventful pregnancy during which she neither smoked nor drank, and on 20 August 1975 her daughter Michelle was born. It was discovered immediately that Michelle had been born with a hole in her diaphragm, which had allowed her bowel and spleen and part of her liver and kidneys to be forced into her chest cavity, crushing her lung. Michelle was not expected to live, but through the skills of our national health service she survived and is now aged 45.

Throughout her life Michelle has endured numerous operations and surgeries and long, long periods of hospitalisation and 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 these debilitating physical, psychological and medical extremely challenging health conditions suffered by Michelle and her parents for the last 45 years just cannot be adequately described in words.

I must say it is quite hard to speak unemotionally after hearing the tragic story that the hon. Member for Ayr, Carrick and Cumnock (Allan Dorans) has relayed to the House. How much more difficult must it have been for Baroness Cumberlege to hear dozens, if not hundreds, of such stories of individual human suffering? She came up with a truly magnificent report and the House of Commons had what I thought was one of its best days for a long time when we discussed it, in no small measure due to the Minister for Patient Safety, Suicide Prevention and Mental Health, my hon. Friend the Member for Mid Bedfordshire (Ms Dorries) and her response to the report. We would all have felt quite justified in thinking that, at last, there was real light at the end of this horrible, terrible, awful tunnel, but it does not seem that we have got to the end of it yet.

I took from Baroness Cumberlege’s report one particular area of hope, and that was the establishment of the specialised mesh centres, and I wish to focus in my contribution on three questions. First, are the mesh centres truly dedicated and comprehensive one-stop shops offering all the types of treatment likely to be needed and all the types of investigation likely to be required, if not under one roof, then at least within a single footprint, or are they merely specialists hubs in name only?

Secondly, there is another problem related to the centres. Are we seeing a situation in which surgeons who could have been described as mesh problem deniers are now reinventing themselves as mesh problem remediators? I do not think they are qualified to hold that role. I fear that there is an attitude of mind that says, “Well, it’s not that easy to find people who specialise in this area, and therefore, even though these are the people who put the mesh in, maybe they are the people who are best qualified to take the mesh out.” I absolutely refute that. Not only did those people put the mesh in, but when the patients came along time and again to say what terrible problems they were suffering, those were the people who refused to listen to them. They were the people who, in some cases, insisted on putting more mesh in, and they were the people who, in other cases, refused to let the patients have a referral to figures such as Miss Sohier Elneil in London or Professor Hashim Hashim in Bristol, who are—or were at that time—the true, and possibly the only, specialists in mesh removal.

I said this in my speech, but it is worth emphasising again. We are talking about what needs to be done and what is happening, but we must also come back to people; as my right hon. Friend says, people are very important. Women are killing themselves. They are killing themselves. Look at the suicide rates for women with mesh problems and endometriosis. Women go through crippling pain, and dozens a year are taking their own lives. Does that not make the point that my right hon. Friend is making—that we have to move more quickly on this?

It totally does. I shall share a little something with the House. Although it does not compare with the agony of what these women are going through, I lost a year and a half of my life when I was given some inappropriate treatment that resulted in my being unable to read for a year and a half during my early 20s. What really made it worse was the knowledge that, if I had not asked for a particular treatment to try to improve my tired eyes because I was studying, none of it need have happened. How much worse must it be for these women, many of whom are not only undergoing all this suffering, but are undergoing it because they were told it was a minor procedure and they thought, “Oh, well—maybe I will have it, then.” If only they had known, they would never have gone within a mile of it. They must be saying that, over and over again. To expect them to go back to the same surgeons who did not tell them what the consequences could be is inhumane and totally unrealistic.

The issue of some people having a financial interest in promoting certain products has been touched on. We are obliged to declare our interests in this House and perhaps something like the Physician Payments Sunshine Act would be the equivalent for people in this context.

Finally, Kath draws attention to what she calls a black hole in official statistics. She says, for example, that according to hospital statistics, in the year 2008-09, 1,038 women were readmitted to hospital with problems within 30 days of a mesh sling having been implanted. In comparison, data derived from surgeons says that only 104 women were admitted to hospital—that is something like 10% of the total. Some 934 women have somehow gone missing from the surgeons’ data.

These are strange and disturbing features. This House has shown itself at its best in condemning what happened. The Government need to build on that and put in place the measures recommended by the report to make it far less likely that it could happen again.

As I am chair of the all-party parliamentary group on valproate and other anti-epileptic drugs in pregnancy, my comments are on that issue. However, I just want to note the harm done, the hurt caused and the justice needed for victims of surgical mesh and Primodos, who are in a similar position to those who have been harmed by sodium valproate.

One of the common threads that runs through all three campaigns is the way in which, more often than not, it is women who are the victims and it is women’s concerns that have been dismissed. Justice, frustratingly, always seems just out of reach.

One year on from the report’s publication, we really are not much further forward when it comes to sodium valproate. NHS England wrote recently to all women and girls aged 12 to 55 who are currently prescribed sodium valproate, reminding them of the risks of taking it while pregnant. That is a step in the right direction, but it has taken a year. One letter is not going to resolve the issue. The Government really must explain what further action will be taken and over what timescale.

Baroness Cumberlege’s report included nine general recommendations, in addition to a number of specific recommendations on sodium valproate. In January, the Minister provided the Government’s initial response to the recommendations. However, she only responded to the general recommendations and not the specific recommendations on sodium valproate. The Government have since stated on a number of occasions that they will respond in full later this year. Do the Government still plan to make a full response this year and will they address the report’s specific recommendations on sodium valproate?

I have a few brief comments about recommendations 3, 4, 5 and 9 of the report, before turning to the specific recommendations on sodium valproate. I would appreciate an update from the Minister.

Recommendation 3, which is for a new independent redress agency for those harmed by medicines and medical devices, has not been implemented, and it appears that the Government are unwilling to do so. May I express how hugely disappointing that is, given the avoidable harm that so many families have experienced? The case for an independent redress agency remains strong. Other countries have successfully set up an agency without such a mechanism, and people who have suffered avoidable harm following healthcare treatment have no option but to go to court, which is such a lengthy, expensive, confrontational and stressful process.

Before we go any further, may I make an appeal to hon. Members who are speaking from home to remember that those who are here in the Chamber still have to get back to their constituencies this evening—and that usually that which can be said in 10 minutes can be said more effectively in five or six?

Thank you, Madam Deputy Speaker; you will pleased to know that I will probably speak only for approximately three minutes, having got used to that time limit.

I am glad to have the opportunity to speak in today’s important debate, one year on from the publication of Baroness Cumberlege’s independent medicines and medical devices safety review. I thank Baroness Cumberlege and her team for their work, and of course the women who bravely shared their horrific experiences, which shone a light on the horrors of the mesh scandal. Without their bravery, the review would not have been possible.

It is vital that the Government continue to listen to the victims who were ignored for far too long. I was glad to hear reassurances from the Minister, following the publication of the report, that the Department is committed to doing so. I was proud to support the Medicines and Medical Devices Act 2021, part 1 of which established the role of an independent commissioner for patient safety and states:

“The Commissioner’s core duties are to…promote the safety of patients”.

If that prevents the repetition of any one of the mistakes from the past, it will have reduced pain and suffering for our constituents, and it will have done its job.

In my time as a high street solicitor, I acted on behalf of a number of clients who experienced horrific difficulties as a result of mesh implants, like those so clearly outlined by my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke). The trauma that mesh patients underwent was truly horrendous, and it is shameful that it took so long for action to be taken and for women’s voices to be heard.

I welcomed the announcement in February by NHS England and NHS Improvement’s women and children’s programme of care that it is commissioning specialist services for women with complications with mesh inserts. The regional centres will ensure that women receive specialist treatment to mitigate this awful suffering. I encourage County Durham and Darlington NHS Foundation Trust to ensure that its patients access the appropriate treatment applicable for the mesh implants they have and to get access to the justice they deserve.

I thank the hon. Gentleman most profusely for his brevity.

There are quite a few people I want to pay tribute to. First, I thank the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy), who is unfortunately not in her place, for bringing forward this very important debate. I pay tribute to the hon. Member for Lancaster and Fleetwood (Cat Smith); I am fortunate and proud also to be a member of the APPG for valproate and other anti-epileptic drugs in pregnancy. Between the work that she does with her constituents, and my constituents, they really are a force to behold.

I turn—very awkwardly—to my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke), who made the important but depressing point that it does appear that women’s health only seems to be paid any real attention when men talk about it. That is a depressing thought for every man and woman in this Chamber, and for every woman out there in the country. It should not take a man to come forward and say, “There’s a problem that we need to listen to”. There are women going to their GPs who are not being listened to. There are women who have been medically gaslighted and told, “You don’t have this; you might have something else” or “It’s just a bad period. Why don’t you try some more painkillers?”. That is wrong. As my right hon. Friend said, endometriosis can take nearly nine years to be diagnosed and a number of women unfortunately end up taking their own life because they cannot cope with the daily pain. That is something of which we should all be shamed. We must do everything we can in this Chamber to put it right.

I want to talk about sodium valproate in particular. I will try to keep my comments brief, because the speech of the hon. Member for Lancaster and Fleetwood covered the main ethos of the debate. It all comes down to what Baroness Cumberlege said in her report. For decades, the healthcare system has neglected to inform patients about the effects of valproate on unborn babies when it is taken by mothers during pregnancy. Those effects include physical malformations, autism and developmental delay in many children.

I congratulate my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) on obtaining this debate. I am chair of the all-party group on hormone pregnancy tests, which contains 135 MPs. This is just one of the countless times I have stood on the Floor of this House on behalf of thousands of victims affected by the hormone pregnancy test drug Primodos to plead with this Government’s Ministers to do the right thing. I have used most of my Prime Minister’s questions and Health orals on this issue. Some 1.5 million expectant women in the UK were prescribed Primodos, a hormone-based pregnancy test used in the 1960s and 1970s that caused them to have babies with malformations and disabilities, to have miscarriages and to have stillbirths. For decades, these families have been dismissed and have been told repeatedly that despite all the evidence of a cover-up, it is all in their heads and there is no link. So imagine my relief, and theirs, when one year ago today the Cumberlege review was published. It was the most comprehensive assessment of all the evidence on the hormone pregnancy tests and it said very clearly that Primodos caused avoidable harm. The report exposed widespread systemic failings, where warnings were ignored. For hundreds of Primodos families across the country who had campaigned for the truth and closure, the conclusion of this report was a significant moment of recognition. The review also said that had Primodos been removed from the market in 1967, when concern was first raised, many of these families would not have endured the decades of suffering. It was also very clear that compensation should be made available for these people.

Today, we are in this House to ensure that this report does not gather dust, which the cynic in me would say is the Government’s intention. I pay tribute to Baroness Cumberlege, who is sitting in the Gallery today, for conducting this review and to her colleagues. The review was thorough and sensitive over the course of two and a half years. Baroness Cumberlege has been so affected by this report that she has set up an all-party group on first do no harm. In her review, she found that the root cause was a failure of the healthcare system by some in the medical profession who have ignored the concerns of women and their families. From these findings comes clear guidance and recommendations on how to support these people and ensure that these things do not occur again. The Minister will be aware that in Scotland some of these measures have been implemented so I would like to ask: why the delay in this Department? The Government refuse to acknowledge the Primodos families and instead keep telling us, “We refuse to comment due to an ongoing legal action.” That is a smokescreen, an excuse, a deliberate refusal to accept that Primodos families deserve justice. Baroness Cumberlege remarked in the other place that

I am pleased to speak in this debate on such an important inquiry. I pay tribute to Members across the House for some outstanding speeches today, and to those who have campaigned for so long to draw attention to the issues that have been addressed in this excellent report, which I think reflects very clearly the distress shared by hundreds of affected patients and their families.

I want to focus on problems with mesh implants, which have been raised with me by many constituents, and most recently by Nicole MacNiven. Nicole has been in constant pain since her mesh was fitted four years ago, and she of course wants to see action on the back of this report. The timelines of events contained in the report make for salutary reading. In each case, warning signs were dismissed, patient and practitioner concerns disregarded, and those at the heart of the healthcare system allowed professional or commercial concerns to outweigh the interests of patients. As a result, decisions on harm avoidance were delayed, allowing many more women’s lives to be diminished or destroyed, and sometimes also those of their babies.

In the case of mesh implants, concern was expressed for many years, but it took until 2014 before the Scottish Government took the lead and called for a suspension of their use, something the MHRA should have done long before. Baroness Cumberlege’s words are very direct and very telling when she reviews the many treatments and devices the inquiry was asked to investigate, but which fell outwith its remit. She concluded:

“Concerns about these…point to a healthcare system that cannot be relied upon to identify and respond promptly to safety concerns.”

That certainly describes the case of mesh implants, and these words should be a wake-up call for the new Secretary of State for Health and Social Care, as he takes over responsibility for a regulatory system for the whole UK that is in serious need of reform. As the inquiry makes clear, the healthcare system takes far too long to pull back to a place of safety when warning signs emerge or, as Professor Ted Baker puts it, there is an “insidious” culture of defensiveness and blame.

Along with other Members here, I took part in the debates on sodium valproate in 2017 and on vaginal mesh in 2018. I welcome the fact that Baroness Cumberlege’s inquiry covered both of these issues, along with Primodos, a hormonal pregnancy test that, like valproate, contributed to congenital abnormalities. At the time of our debates, it was clear that the same underlying issues had driven all three disasters and that there were four main features: a failure of licensing and regulation in the first place, particularly regarding implantable devices such as vaginal mesh; a lack of accurate information so doctors could discuss the risks of these drugs and devices and allow patients to give genuine, informed consent; a weak and poorly publicised system for doctors or patients to report adverse events that would result in action; and finally, the failure of doctors to listen to the affected women who were raising concerns.

The report makes nine recommendations, with two main aims: the need to provide remedial support and redress for the women and children affected; and how to prevent something similar happening ever again in future. The report also captures the experiences of women who have been campaigning on these issues for years, which are well summarised on the report’s contents page:

“‘No-one is listening’—The patient voice dismissed…‘I was never told’—the failure of informed consent”.

Considering the evolution of these disasters, I would perhaps reverse those two aims, as the problems started with the failure of regulators to ensure that these drugs and devices were safe and to provide accurate information on which women and their doctors could base treatment decisions.

I will focus my remarks on vaginal mesh, as there were additional issues associated with its licensing and use. In particular, the original trials comparing mesh with traditional abdominal operations did not have a long enough follow-up. This meant that while immediate surgical complications such as bladder injury were seen to reduce from one in 10 to one in 100, the later mesh complications were not identified. This led to the original vaginal mesh tapes being defined as low-risk devices and gynaecologists switching to this approach as it actually appeared safer for patients.

It is a pleasure to speak for the Opposition in this important debate and I commend the Backbench Business Committee for choosing it. It has been an excellent debate and that started with those who secured the debate. I congratulate my hon. Friend the Member for Kingston upon Hull West and Hessle (Emma Hardy) and the right hon. Member for Elmet and Rothwell (Alec Shelbrooke) on securing the debate and on their leadership of the all-party parliamentary group on surgical mesh. There were common themes: the hope we all felt when we read the Cumberlege review a year ago and how keen we all are to make further progress. The right hon. Member for Elmet and Rothwell said he wanted to reinvigorate the debate. I think that that has happened today—very much so.

I also recognise the contributions of the right hon. Members for Maidenhead (Mrs May) and for South West Surrey (Jeremy Hunt) because we probably would not be here without their personal leadership. I do not think it is a secret that we on the Labour Benches sometimes disagree with them on matters of health policy, but not in this regard and particularly not with their iron clad commitment to patient safety.

I want to pay a special tribute to my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson), my predecessor as shadow public health Minister. It tells us everything we need to know about her that she might have gone on to other roles on the Opposition Front Bench, but she is still at it on these issues. It is never just a job for her, but a campaign and a drive to do it. We are very lucky to have her. She helmed an all-star cast of Labour Members who have been working very hard on this issue: my hon. Friends the Members for Blaydon (Liz Twist) and for Lancaster and Fleetwood (Cat Smith) on sodium valproate; and my hon. Friend the Member for Bolton South East (Yasmin Qureshi) with her leadership and passion around Primodos. I thought their contributions were very good indeed.

Today is the first anniversary of the publication of the Cumberlege review. It was a seismic report, one that vindicated campaigners who in many cases had fought for decades. It showed how they had been denied, derided and ignored. Crucially, it gave us nine concrete ways forward—nine ways to start to meet the obligation we have to these women and the families affected. I wish we had heard in the oral statement the following day last year an acceptance from the Government of all the recommendations and I wish we were speaking about the progress we had made in implementing all nine. I am sad that we are not. However, I will start by recognising the progress that has been made.

I thank the hon. Member for Kingston upon Hull West and Hessle (Emma Hardy) and my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke) for securing this debate on the implementation of the recommendations of the independent medicines and medical devices safety review.

Hon. Members have spoken passionately across a range of issues mentioned in the review, but before going into the detail of the recommendations I want to make a number of main points. First, the hon. Member for Bolton South East (Yasmin Qureshi) raised that issue of Primodos with huge passion again today, but I am afraid I have to rebut her criticism. I am not allowed as a member of the Government to discuss an issue that is sub judice and that is a live litigation in the courts at the moment; I am simply not allowed to do that. I have made this point a number of times and cannot make it much clearer: as a Government Minister, I am not allowed to discuss something that is in the process of live litigation.

Will the Minister give way?

I will not, as I am about to move on to the other matters raised. I would also say that as a Government we make our decisions on the basis of scientific recommendations, and the scientific evidence provided to us at this moment in time does not support there being a causal link between Primodos and adverse outcomes in pregnancy. I am afraid that is all I am allowed to say. So on Primodos I say to those who have raised the matter that I hear everything they say and I hear the issues, but because it is sub judice I am not allowed to comment.

Will the Minister give way?

I will give way, but I am afraid I will not be allowed to comment.

I thank the hon. Lady for giving way. I heard both the points she made, but would the victims be compensated if the legal proceedings were withdrawn, or is this issue about the expert working group still going to be an obstacle?

I apologise, but I cannot answer the question.

Moving on, I want to address sodium valproate, in general terms now and later in more detail. I have heard the speeches today and some pertinent points were raised, and I would like to make an overall point on valproate again before going into the recommendations: valproate is a drug that saves the lives of women who can receive no other treatment for their epilepsy. Some women suffer life-threatening epileptic fits of such severity that only sodium valproate can save them; their lives would be lost if they did not take sodium valproate. Therefore it is not possible to ban the use of sodium valproate, because those women’s lives would be compromised.

A number of changes have taken place, too. A letter was sent out to women taking sodium valproate to make sure they were aware, and other measures have been put in place, which I will discuss in a moment, including ensuring that prescriptions for sodium valproate go into one box rather than being partial prescriptions, and the boxes have very clear and significant warnings on them. I could go into further detail, but the inquiry covers—

Will the Minister give way?

No, because the hon. Lady will be able to respond at the end of the debate and, without going into a huge amount of detail, I want to address a number of overall points that I feel can be made clear.

First, I thank Baroness Cumberlege for her report, of course. She is sitting in the Public Gallery—watching over me, as she does every day. I am delighted and not surprised that she is here, and we are all grateful to her. The report was commissioned by the then Secretary of State, my right hon. Friend the Member for South West Surrey (Jeremy Hunt), in response to public concern. It examined how the healthcare system in England responded to reports about harmful side-effects from the three specific subjects discussed today. Baroness Cumberlege was asked to chair the review. It is just not possible to do the review justice. It took two years, it was incredibly thorough, and it listened to so many voices on so many complex issues. It is not possible to do this overnight. No review undertaken by any Government on issues as serious as these has been implemented rapidly. They take a lot of discussion, time, evaluation and implementation by the NHS.

The review was published on 8 July 2020 and contains nine strategic recommendations that have wide-ranging implications for the healthcare system. That is why it is not possible to implement them rapidly. I pay tribute to the women and families who bravely shared their experiences and brought these issues to light.

Recommendation 1 was an apology. A year ago, I made that apology, and I will make it again. Having met the patient reference group members, spoken to those who have been harmed and read the report, which makes very harrowing reading, I want to make that apology again. I am desperately sorry. I have heard the stories of harm, which are harrowing. I am desperately sorry for those women who have been harmed. Of course, we all want to ensure that this ends and never happens again. The Government absolutely recognise the need for effective patient engagement to begin to rebuild trust and to ensure that we get the implementation right. That is why we established the patient reference group to work with the Department to develop this response. My officials and I have met the group regularly to gather their insights and to ensure that patient voices are heard as we progress towards a full response, which will be given in this place at the Dispatch Box before the end of this year.

I thank everybody who has taken part in this debate, and particular thanks again go to Baroness Cumberlege. May she continue to look over and down upon the Department of Health in ensuring that these recommendations are, hopefully, at some point enacted.

I would like to make a point about valproate. The Cumberlege review looked at the expert working group report and said it was flawed. On that point again, Epilepsy Action is looking into a campaign called “Safe Mum, Safe Baby” for alternative medications for women to use, and one of the campaigns is to ask the Government for money to help to fund some of that research. I hope that, in the light of the comments the Minister has made regarding valproate, that is something that the Government will look kindly upon.

A comment made by the former Secretary of State for Health, the right hon. Member for South West Surrey (Jeremy Hunt), has stayed with me. He said that this was not just about the lack of justice but about the risk of a repeat. That is why these recommendations matter, not only for justice for the women harmed but because of the risk of repeating this. I look forward to not having to hold this debate again on next year’s anniversary, but I am sure, if necessary, we will all be here—same time, same place—next year. Hopefully we will see a few more of the recommendations enacted. Thank you, everyone.

That this House notes the publication of the Independent Medicines and Medical Devices Safety Review, First Do No Harm; further notes the Government’s failure to respond to the recommendations of that review in full; notes the significant discrepancy between the incidence of complication following mesh surgery in the Hospital Episode Statistics and the British Society of Urogynaecology databases, as highlighted in the Royal College of Obstetricians and Gynaecologists’ Project Report, entitled Hospital Episode Statistics as a Source of Information on Safety and Quality in Gynaecology to Support Revalidation; notes that the Government’s plan to publish a retrospective audit to investigate the links between patient-level data to explore outcomes has not been fulfilled; notes that the moratorium on mesh implant procedures should not be lifted until that audit has been undertaken and the true scale of suffering established; notes Ministers’ failure to acknowledge recommendations relating to victims of Primodos; and calls on the Government to fully implement the recommendations for victims of mesh, sodium valproate and Primodos without further delay.