Independent Medicines and Medical Devices Safety Review

With permission, Mr Deputy Speaker, I would like to make a statement about the independent medicines and medical devices review. This review was announced by my right hon. Friend the Member for South West Surrey (Jeremy Hunt) in February 2018, in response to public concern about the safety of medicines and medical devices used by the NHS. It focused on three areas. The first is Primodos, a hormone-based pregnancy test that is claimed to have led to miscarriages and birth defects during the 1960s and ’70s. It was prescribed to more than 1.5 million women before it was withdrawn from use in 1978. The second is sodium valproate, an anti-epilepsy drug that has been definitively linked to autism and learning disabilities in children when taken during pregnancy. The third is the vaginal mesh implants used in the treatment of pelvic organ prolapse and stress urinary incontinence, which have been linked to crippling, life-changing side-effects.

Baroness Cumberlege was asked to conduct a review of what happened in each of those three cases, including whether the processes that were followed were sufficient when patients’ concerns were raised. She was also asked to make some recommendations for the future, such as: how to consider the right balance between the criteria or threshold for a legitimate concern; how best to support patients where there might not be a scientific basis for their complaint, but where they have still suffered; how we can enhance the existing patient safety landscape; and how we can be more open to the insights that close attention to patient experience can bring.

The report has now been published, and a copy has been deposited in the Library of the House. It makes harrowing reading. Every page makes clear the pain and suffering that have been felt by so many patients and their families. As Baroness Cumberlege herself said, they suffered “avoidable harm”. She said that she had listened to the heart-wrenching stories of acute suffering, of families fractured, of children harmed and so much more.

On behalf of the health and care sector, I would like to make an apology to those women, their children and their families for the time the system took to listen and respond. I would also like to thank every single person who has contributed to the review. I know that some of them wanted to be here in the House today. They felt as though their voices would never be heard, but now they have been, and their brave testimony will help patients in the future. I have watched and read some of their testimonies. They left me shocked, but also incredibly angry and most of all determined to make the changes that are needed to protect women in the future. It is right and proper that the victims were the first people to see this report. As a Government, we have now received its findings and, as hon. Members will understand, we are taking time to absorb them before we respond. That is the least that the report deserves. We will update the House at the very earliest opportunity.

I am grateful to the Minister for coming to make this statement today and for providing advance sight of it.

“Ignored”, “belittled”, “derided”, “gaslit”—those who have campaigned to highlight the harm caused by Primodos, sodium valproate and pelvic mesh have been called every name under the sun, but today they are one thing alone: proven right. I thank the noble Baroness Cumberlege for overseeing a piece of work that will make a huge difference to so many people, both today and in the future. It is hard to read, but it is vital that we do, and that we understand it and learn from it. It is really important to note that campaigners have universally said how well the review team treated them.

The review’s report thoroughly investigates what happened in respect of each of the three areas that I mentioned. Although, on the surface, they are separate, they have an awful lot in common, not least that they were all taken and used by women, and in two cases, pregnant women. This is clearly no coincidence, and I was glad to hear the Minister say that the healthcare system must do better to protect women, because these cases reek of misogyny from top to bottom— and of ageism and ableism as well. They also share the reaction of the healthcare system, which, according to the report, failed to monitor the use of these medicines and medical devices, then failed to identify and acknowledge that things had gone wrong, and then failed to work in a joined-up fashion to improve. The healthcare system failed to protect these people. As the review says, it has taken the act of having a review to shine a light on these systemic failings. I share with everybody else the love affair that we, as a nation, have with our health system, but we cannot be blind to its faults, and it is time that we acted on them.

We would not be here without the campaigners. Without their tireless activism—for many decades in some cases—this would have been ignored. I want to take the opportunity to highlight a few of the groups that have done such tremendous work. That is a dangerous game, I know, and I can only apologise to those whom I do not have time to mention. Marie Lyon has led the way in bringing to attention the damage that hormone pregnancy tests, including Primodos tablets, can do. This report has finally proven her to have been right all along, stating that opportunities were missed to remove them from the market. She is right, too, that the Department for Work and Pensions has mugged campaigners over the condition insight report. I hope the Minister will commit to righting that wrong, too. Janet Williams and Emma Murphy, who founded the Independent Fetal Anti-Convulsant Trust—In-FACT—have fought so long to be believed and for action to be taken regarding sodium valproate, the risks associated with which far too many expectant mothers were unaware of. Kath Sansom, who founded Sling the Mesh, has provided so much support for so many people living in incredible pain because of pelvic mesh. This is a sombre day for those people, but I hope that they can take some satisfaction from the fact that their efforts have paid off in this way.

That was a long list of asks. I am sure the hon. Gentleman appreciates that we received the report yesterday, and it is a detailed, in-depth and complex report. He is pushing an open door, with almost everything he asks—patients absolutely have to be at the heart of this. The report is entitled, “First Do No Harm”. Our response has to be to do good. We are listening; I am in listening mode. I have listened to what he has said. I will listen to what everybody here has to say today, and to what all the groups have to say, about the details of the report. We will take it away.

The hon. Gentleman asks how long; I am sure he appreciates that work needs to be done to formulate a response. The response will come as soon as possible, as soon as the work has been done. He is quite right about the role of women, which he referred to at the start of his comments. Whether it is Shipman or Paterson or maternity issues or the Cumberlege report, more often than not women are at the heart of these—for want of a better word—scandals. He is absolutely right, and I feel very passionately about making sure we come back with a really positive and robust response to this report as soon as possible.

I thank the Minister for the compassion and the anger in her response. She is a fantastic champion of patient safety. I also thank the many hon. Members, including my right hon. Friends the Members for Hemel Hempstead (Sir Mike Penning) and for Elmet and Rothwell (Alec Shelbrooke), who persuaded me to commission the report. I, too, would like to thank the brave campaigners who have not stopped until they got justice. I particularly thank Baroness Cumberlege, Sir Cyril Chantler and their team, who did a painstaking amount of work to get to where we are today.

I commissioned this report because I knew that many lives had been ruined because we did not act quickly enough to deal with problems in these three areas, but the results are far more shocking and disturbing than I ever imagined at the time. Thousands of lives have been blighted by what went wrong in the most terrible way. Does the Minister agree that the central issue is not about the three areas alone, but about all medicines and devices where there is no one for patients and people who are suffering to go to with the confidence that they will be listened to? That is why the suggestion of a patient safety commissioner is so important. It is not a tsar or a quango; this would be a person who would listen to people whose voices were not heard. I hope the Government take that recommendation seriously.

Will my hon. Friend give a commitment that the Government will come back to this House before the end of September with their recommendations? We completely understand her tremendous commitment to patient safety, but does she agree that the gravity of this issue is such that it should be the Health Secretary, who made a very important apology yesterday, who comes back before the end of September and tells the House what the Government are going to do?

I pay tribute to my right hon. Friend, who commissioned the review in 2018. Thank goodness he did, because without it, these voices would still be struggling to be heard.

On my right hon. Friend’s question about the patient safety commissioner, as that is a recommendation, it will be considered, as will every other recommendation. It is important to mention that we have Aiden Fowler, whom my right hon. Friend appointed to NHS Improvement to take on the head of patient safety role on behalf of NHS England. That does not mean that we will not consider the recommendation thoroughly; we will do so.

Obviously, I cannot speak for the Secretary of State, but I am sure he is aware of my right hon. Friend’s comments. I cannot commit to coming back by the end of September; what I can give the House is my absolute assurance that I will chase this daily. The work commenced when the report became available to us, and a huge amount of work has been done overnight on assessing the recommendations made in the report. I or the Secretary of State will be back here as soon as possible with our recommendations.

I thank the Minister for advance sight of her statement. Of course, her apology is very welcome.

“We have found that the healthcare system—in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers—is disjointed, siloed, unresponsive and defensive.”

Those words in “First Do No Harm”, the report published yesterday on the Primodos, sodium valproate and pelvic mesh scandals, are a hugely powerful indication of the abject failings that must be addressed by the Government. Credit must go to Baroness Cumberlege and her team for all their work.

Yesterday was a landmark day for victims and survivors of those scandals, and we pay tribute to all the campaigners who fought so hard for so long, including Primodos campaigner Marie Lyon and my constituent Wilma Ord, whose daughter Kirsteen was affected by Primodos. Their fight must now be our fight.

Justice is not served until the recommendations are fully implemented. I understand the desire and the need to reflect on what is needed, but a full commitment to the implementation of all the recommendations is vital. In particular, will the Minister ensure that the taskforce to guide the recommendations is set up at speed and as soon as possible? Will she also commit to vigorous pressure being exerted on companies such as Bayer, which, to be frank, have got away with murder? They are responsible for Primodos and need to pay proper compensation to victims.

Will the Minister ensure that the recommendation of a patient safety commissioner is implemented and the post established as quickly as possible? In the words of Branwen Mann, a young person affected by sodium valproate,

“I know that the full harm done by sodium valproate is barely understood, or even recognised by anyone other than the family that live it.”

That cannot continue.

Finally, will the Minister ensure that the central patient identifiable database is created by collecting details on the implantation of all devices at the time of operation? So many patients affected by surgical mesh and other devices have never had their devices tracked or registered, which in the age of advanced technology is, I am sure she agrees, frankly ridiculous.

Again, that is a list of asks, and as I said in my reply to the hon. Member for Nottingham North (Alex Norris), we will take on board all the requests made and come back in time with a full report.

On the hon. Lady’s last ask, about the database, we have begun working with NHSX on establishing a database of those women who have had the vaginal mesh. We are looking at how those meshes can be safety removed, with their consent and with all the details explained to them. Getting that database together, both historically and moving forward, is work in progress. On the rest of the hon. Lady’s asks, we will be back with a full report, in which all of her points will have been considered.

The three scandals we have heard about are terrible, but can I ask the excellent Minister about the future? I piloted through Parliament the Health and Social Care (National Data Guardian) Act 2020, which should allow us to get more data on problems that arise in the NHS. What further steps will the Minister take so that a future Minister does not have to come to the Dispatch Box to make a statement like the one she has just had to make?

In the Department of Health and Social Care, we work daily and continually on improving patient safety to make our NHS the safest healthcare system in the world. Procedures such as the national guardian scheme, which my hon. Friend mentioned, and others that have been put in place all work towards that goal. This report, tragic and harrowing as the stories in it are, will go a long way towards enabling us to develop systems that enable the patient’s voice to be heard earlier.

That is the core issue. The thread that runs through is how long it takes somebody who has a complaint to have their voice heard and their complaint acted on. That is something that we need to resolve. If we can do that—if patients’ complaints can be heard and can be resolved as soon as they are raised—no Minister will, hopefully, ever have to come to the Dispatch Box in the future, because situations will have been dealt with effectively and promptly, and lessons will have been learned.

My hon. Friend will also be aware that we have introduced the Health Service Safety Investigations Body, and there are other measures that will help us to take the learning from incidents and move forward. Work therefore happens daily on improving patient safety and getting to the place he outlined, where a Minister will never have to come here and apologise again.

I thank the Minister for her statement today. First, may I express my sincere gratitude to Baroness Cumberlege and the review team, who have shown such empathy and understanding to patients, their families and campaigners who have campaigned tirelessly on these issues for years? My mam is one of the thousands of patients who had her life and her health ruined because of this quick fix with a bit of tape. She was never warned of the damage that this plastic mesh could cause her body.

The review recommends setting up a network of specialist centres to provide comprehensive treatment, care and advice for those affected by implanted mesh, and that is to be welcomed. Does the Minister agree, however, that it would be abhorrent for any of those centres to be led by any of the surgeons who promoted mesh or put it into women, knowing it damaged them? For some women, it has caused the most unimaginable pain and life-changing damage.

I thank my hon. Friend—I do regard her as a friend because she is such a principled campaigner on issues such as this. I hope she does not mind my saying that I know that her mother gave evidence to the review and went along to one of the hearings. I thank her for that, because it was a very brave step to take. This is not an easy thing to talk about, so that was incredibly brave of her. We owe her for her bravery in coming forward, and I thank the hon. Lady for mentioning that.

I completely agree with the hon. Lady. I cannot comment on the specific point about individual doctors with expertise because work has to go forward on removals of meshes and on where we go in the future. However, on specialist centres—I think she is aware of this—NHS England is assessing bids from NHS providers to become specialist centres and to provide treatment for women with complications from mesh inserted for urinary incontinence and vaginal prolapse. Following the covid-19 pandemic, during which some of this work has unfortunately been halted, every effort is now being made to finalise the centres quickly. Stakeholders will be kept up to date with progress, but we do want to see more of that work.

In October 2017, I stood in this very spot with the report in my hand, and it was a whitewash. It was disgusting to the victims—we have not heard that word yet today, but they are victims—of what has gone on in these three terrible cases. In particular, the Primodos victims were shown no compassion in the report and were in many ways blamed for what had happened to their children.

The new report is completely different. I apologise to my right hon. Friend the Member for South West Surrey (Jeremy Hunt), who was the Secretary of State, because I was critical of the three problems’ being put to Baroness Cumberlege in one inquiry; I thought it would be much better if each was looked at individually. I apologise to Baroness Cumberlege, because I said that to her as well as to the then Secretary of State, and I was wrong. This report is probably the best report on what has gone wrong inside the NHS that I have ever seen.

The NHS does wonderful things, but it gets things wrong. We all praise the NHS. We stood outside last weekend—I hope people did—and praised the NHS on its 72nd anniversary. But when it gets it wrong, it gets it seriously wrong. In 1967, it knew that Primodos was a danger: the company knew and the NHS knew. Young women went to their GP, and said, “I think I might be pregnant”. Very often, no prescription was issued. There were no warnings and no concept of what could happen to their foetus if they were pregnant. The drawer was opened and the tablets were given to them. Those tablets were given by the drug company to the GP, who in many cases did not even issue a prescription.

Today, we have the report, with nine recommendations, but how are we going to compensate those families? It is not just for the women, but for their families, including the men who have stood next to them, such as Marie Lyon’s husband, who has been with her all the way through. How are we going to compensate those who lost their baby, who were told to abort their baby or who had a stillbirth? How are we going to compensate and help those families when the loved ones, the mums and dads of the survivors—they have terrible disfigurements, and they did brilliantly well to give evidence for the report—are no longer with us and the survivors need such support afterwards? While we must make sure this never happens again, we must also make sure that we look after those families and that the drug companies pay for what they did to those families.

My right hon. Friend makes an impassioned and compassionate contribution, and he should be recognised for his long-term campaigning and his advocacy of the people he mentions who have suffered as a result of what has happened. I cannot comment on the individual points he has raised, particularly on Primodos, because there is legal action pending, but I hear everything he said and others will hear his comments too.

I thank Baroness Cumberlege profusely for her review’s welcome conclusions on Primodos, and I praise the Sky journalists who have worked on this, and Marie Lyon and all the other campaigners. However, can I tell the Minister that I see this just as the beginning of the end, because we have not yet got justice for the women involved or their adult children? We want to see the conclusions implemented as soon as possible, and we want to see compensation for the women and their adult children. But I also want to see criminal charges brought against the real perpetrators of this scandal for the cover-up, the suppression of the evidence of harm, and the marketing and sale of a drug that Schering and Bayer knew was dangerous and would result in miscarriages and birth defects.

I am grateful for the way that the Minister has produced her statement today. Will she ensure that her Department, the Department for Work and Pensions and the rest of Government know that we will not stop campaigning until full justice is given to these women and their adult children?

I commend the right hon. Gentleman for his compassion and for his commitment to campaigning on this. I just have to repeat what I said in my previous answer. I have every—every—sympathy with every parent, mother and family who have been affected, but due to pending legal action I cannot make a statement.

Today is a day of strongly mixed emotions—one of joy that we have such a comprehensive and thorough report recognising what many women and others have been through, and of course one of absolute sadness and anger that it ever had to come to this. I first raised the issue of sodium valproate in 2013 or 2104, and vaginal mesh in October 2017. I pay tribute to my right hon. Friend the Member for South West Surrey (Jeremy Hunt) for putting the inquiry in place, and to my hon. Friend the Minister for the way that she has handled today’s statement.

The Government, as my hon. Friend said, are now going to take note of what happened. I would like two particular areas to be looked at. First, we need to make sure that the complaints commissioner is thoroughly independent of the healthcare sector, because we cannot again ask people to mark their own homework. Secondly, there is the issue of powers of redress and ex gratia payments. One of my constituents has had to borrow tens of thousands of pounds to correct her mesh implant through private surgery. This operation was done and recommended by the NHS. If we could speedily get these recommendations in place and compensate women who have had to take on their own financial burden to correct this surgery caused by the NHS, that would be most welcome.

I thank my hon. Friend for his comments and for his campaigning. It is the campaigning of Members of this House on behalf of their constituents that has got us to the position where we are today. It demonstrates how this place works at its best when MPs represent their constituents in campaigning on issues such as this. On his specific question, I would like him to write to me, because I am not quite sure why, if the operation was undertaken by the NHS, his constituent had to pay tens of thousands of pounds. If he would like to write to me and let me know the details, I will give him a more detailed response.