Independent Medicines and Medical Devices Safety Review
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The Minister for Patient Safety, Mental Health and Suicide Prevention (Ms Nadine Dorries)
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 It was prescribed to more than 1.5 million women before it was withdrawn from use in 1978.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 into 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 for harrowing reading. Every page makes clear the pain and suffering that has 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 would like to thank Baroness Cumberlege, who has carried out her work with thoroughness and compassion. She has worked tirelessly to ensure that patients and their families have been heard, and I would like to pay tribute to her and her team. I know that the patients’ stories that they have heard have been harrowing and, at times, frankly beyond belief. She has done us all a great service by highlighting them, along with the suffering of so many women and their families. I know that there will be strong feelings across the House about the report, and that hon. Members will be eager to hear a fuller response. However, it is imperative for the sake of those who have suffered so greatly that we give the review the full consideration that is absolutely deserves.
It is clear, as I am sure the whole House will concur, that the response to these issues from those in positions of authority has not always been good enough. The task now is to establish a quicker and more compassionate way to address issues of patient harm when they arise. We must ensure that the system as a whole is vigilant in spotting safety concerns, and that we rapidly get to grips with the concerns identified by the report. We must make sure that different voices are invited to the table and that patients and their families have a clear pathway to get their answers and a resolution. The issues tackled in this report are, from one perspective, complex—matters of regulation, clinical decision making and scientific judgment—but there is one simple core theme that runs through all of this, and it goes to the heart of our work on patient safety. It comprises just two words: listening and humility. So much of the frustration and anger from patients and families stem from what they see as an unwillingness to listen—for us to listen and for them to be heard. We need to make listening a much stronger part of clinical practice and to make the relationship between patients and clinicians a true and equal partnership.
While the review has been progressing, the Government and the NHS have taken a number of steps relating to the concerns it has raised. However, there is always more that we can do, and it is clear that change is needed. We owe it to the victims and their families to get this right. I commend this statement to the House.
Alex Norris (Nottingham North) (Lab/Co-op)
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 see that the Minister referenced that the healthcare system must do better to protect women, because these cases reek of misogyny from top to bottom— and 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 act 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 that their efforts have paid off in this way.
I would not often say this, but this is a day for parliamentarians, too. It was not clinicians or regulators who brought this to the surface. It was right hon. and hon. Members who listened to and believed campaigners and fought for them, too. Again, there are too many to name, but I will mention my hon. Friends the Members for Bolton South East (Yasmin Qureshi), for Kingston upon Hull West and Hessle (Emma Hardy), for Lancaster and Fleetwood (Cat Smith), the right hon. Member for Elmet and Rothwell (Alec Shelbrooke), my hon. Friend the Member for Blaydon (Liz Twist) and my predecessor as shadow Public Health Minister, my hon. Friend the Member for Washington and Sunderland West (Mrs Hodgson).
There is not time for me to cover all the recommendations, but I want to highlight a few. Recommendation 1 calls for a fulsome apology. It was right that the Minister did that, and it will be greatly appreciated. Recommendation 3 of the report calls for a new independent redress agency for those harmed by medicines and medical devices, to create a new way of delivering redress in the future. It suggests that manufacturers and the state could share the costs. I would be interested in the Minister’s reflections on that. When does she think that could be implemented by?
Recommendation 4 suggests separate schemes for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to all those who have experienced avoidable harm. That is the ethical responsibility of the state and manufacturers. Will the Minister today commit to that recommendation —to providing some redress for those who have suffered avoidable psychological, physical and neurodevelopmental harm? Will she commit, critically, to work on that with these people? For too long, they have had things done to them and they are owed the opportunity to shape their futures.
On recommendation 6, regarding the Medicines and Healthcare Products Regulatory Agency, I said at every stage of the Medicines and Medical Devices Bill that the timing for that Bill was challenging, although that was inevitable as we had to get on with it, because the report would have profound implications for the MHRA—and, boy, does it. I would like the Minister to commit to amendments in the other place to make sure that the MHRA regulatory regime is as strong as possible.
Finally, and absolutely critically, recommendation 9 calls for the immediate creation of a taskforce to implement the recommendations. Will the Minister commit to that? It was right for her to say that she needed time for reflection, but I would be keen to have a definition of how long she feels the Government will need to reflect.
This is a sombre moment. It is incredibly hard to read the report, but it is vital that we do so. Campaigners and those affected have got justice today; now they need action. We will not let the report gather dust on a shelf. We will be fighting every day to get the recommendations implemented and to meet the needs and the expectations of those who have fought for so long.
Ms Dorries
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 on an open door, with almost everything he asks—patients absolutely have to be at the heart of this. The report is titled, “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, to 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.
Jeremy Hunt (South West Surrey) (Con)
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; they 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?
Ms Dorries
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.
Hannah Bardell (Livingston) (SNP) [V]
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.
Ms Dorries
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.
Mr Peter Bone (Wellingborough) (Con) [V]
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?
Ms Dorries
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, as 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.
Mrs Sharon Hodgson (Washington and Sunderland West) (Lab) [V]
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.
Ms Dorries
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.
Sir Mike Penning (Hemel Hempstead) (Con)
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.
Ms Dorries
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.
Sir Edward Davey (Kingston and Surbiton) (LD)
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?
Ms Dorries
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.
Alec Shelbrooke (Elmet and Rothwell) (Con)
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 can 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.
Ms Dorries
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.
Cat Smith (Lancaster and Fleetwood) (Lab)
As chair of the all-party parliamentary group on valproate and other anti-epileptic drugs in pregnancy, I would like to put on the record my and the group’s thanks to Baroness Cumberlege for her work on this. We welcome the report. I believe that its recommendations should be implemented in full as quickly as possible, because it is 268 pages about four decades of women being let down and lied to. When those women have campaigned for justice, Members of this House have told them that they are bored housewives and they are being hysterical. We cannot allow these women to be denied justice any longer. I would like to invite the Minister to join a meeting of our all-party group so that we can talk about the recommendations in more detail in a way that we cannot do on the Floor of the House.
Ms Dorries
I could not agree with the hon. Lady more. As I said earlier, whether it is Shipman, Paterson, Cumberlege or a maternity incident, women so often struggle to get their voices heard when they are at the heart of issues like this. I would be happy to talk to the all-party group, particularly on sodium valproate, where a huge amount of work is being done. We are seeing the number of users of sodium valproate in pregnancy declining, but there is more work to be done. I would be particularly interested in talking to the hon. Lady about how we get the message out about the dangers of sodium valproate, because there are women who suffer from epilepsy for whom sodium valproate is the only treatment that works effectively. That is the heart of the problem that we need to keep discussing and work through further. I am happy to meet and talk to her.
Dr Ben Spencer (Runnymede and Weybridge) (Con)
The NHS collects a wealth of data in different clinical settings, but often computers and systems do not talk to one another; they are silent. What is on a GP’s computer may not be on a hospital computer or a health visitor’s computer, and this report highlights the critical need for registries and data that are systematically collected. Can the Minister assure me that another registry or dataset will not end up isolated and silenced, as many of the victims were before this report?
Ms Dorries
I thank my hon. Friend for that point. I had a thought while I was listening to him, which is that I did not mention Sir Cyril Chantler in my statement, the doctor who contributed hugely to the report, along with Baroness Cumberlege. I thank both of them. They worked as a team—even though it is the Cumberlege report, they worked together, and Sir Cyril deserves recognition and thanks for his work.
I agree with my hon. Friend. Because of the many reports a number of regulatory bodies have been established, but it is in their talking to each other and the bridges between them that we have problems. We recognise that this is a complex area. However, we have already gone beyond the development of the database. The Medicines and Medical Devices Bill was amended in the House, with cross-party support, to create a power to establish a medical devices information system. That will respond to Baroness Cumberlege’s recommendations in full, including ensuring that private providers that do not operate under the NHS contract can be required to provide data to that information system. NHS Digital is leading work with system partners and the devolved Administrations to ensure that this comprehensive database can be used to support clinicians and the MHRA. My hon. Friend is right to say that in the development of the database, all the organisations and regulatory bodies need to work together and support one another.
Yasmin Qureshi (Bolton South East) (Lab) [V]
As chair of the all-party parliamentary group on hormone pregnancy tests, I am proud to have campaigned with Marie Lyon for the Primodos families for almost a decade. I welcome the recommendations in the Cumberlege review, and I pay tribute to Baroness Cumberlege and her colleagues for their integrity and unflinching courage, but campaigners like Marie should not have had to give up their entire lives to pursue truth and justice. This is a scandal that should never have happened, and it is one of the greatest medical frauds of the 20th century. When I first raised this with Ministers in 2012, and several times with Prime Ministers since then, I was dismissed. I was met with constant denial, and doors were slammed shut at every turn. Can the Minister assure the House that enough is enough and that the Cumberlege review is a turning point for the Primodos families?
Ms Dorries
I thank the hon. Lady for her ardent campaigning on this issue. I can only say again that I have absolute sympathy with the families on whose behalf she has been campaigning, but once again I refer to my earlier answer: owing to pending legal action I cannot comment on Primodos.
Laura Trott (Sevenoaks) (Con)
This report was an incredibly difficult read, but what one of the things that stuck with me most is the guilt that so many mothers have felt for taking drugs that inadvertently harm their babies. I would like to echo what is said in the report: this was not your fault. Please can the Minister reassure all pregnant women across the country and the House that action has been taken to improve the monitoring of drugs used during pregnancy?
Ms Dorries
I thank my hon. Friend for her comment. She is absolutely right. The report is entitled “First Do No Harm”, and we here have to do some good in response to it. Work is being undertaken—the all-party group for valproate and other anti-epileptic drugs in pregnancy works incredibly hard. It is about getting information out there. For some women with epilepsy, sodium valproate is the only drug that works, and the pregnancy prevention programme works alongside this. As I have said, I cannot comment on Primodos, but work is ongoing. We have seen a decline in the number of pregnant epileptic women taking sodium valproate. That decline needs to be driven down even further, in tandem with the pregnancy prevention programme, but my hon Friend is absolutely right. I hope that nobody ever has to come to the Dispatch Box again to discuss a report such as the Cumberlege report and have to apologise for what happened, with the glaring inconsistences in treatment that has been provided to those women who have not received the information they should have received when taking those drugs.
Barbara Keeley (Worsley and Eccles South) (Lab) [V]
After decades of having their concerns dismissed and struggling to be heard, the victims of these scandals deserve both the apologies we have heard and ex gratia payments for the avoidable damage they suffered. Will the Minister confirm that it will be a priority to establish the independent redress agency recommended to help those affected by these scandals and a priority that the agency will be able to move quickly to provide the redress that the victims deserve? They have waited long enough.
Ms Dorries
Every recommendation in the report is a priority and everything will be given equal consideration. I hope that either I or the Secretary of State will be able to come back to the House as soon as possible after the report has been evaluated in full and make our own recommendations at that time.
Chris Green (Bolton West) (Con)
I thank my hon. Friend for her statement. Will she confirm that the Medicines and Medical Devices Bill incorporates steps to establish a database of medical devices, including information about device safety, which is a key part of the Cumberlege review? I wish to pay tribute to the many campaigners for their tireless work and, in particular, to my neighbour the hon. Member for Bolton South East (Yasmin Qureshi) for her work on Primodos.
Ms Dorries
I thank my hon. Friend for that. The Bill makes it clear that patient safety is paramount in any regulatory change on medicines and medical devices in the future. The Bill will allow us to implement a framework to continue to update and amend the Medical Devices Regulations 2002 and the Human Medicines Regulations 2012 to respond to patient safety concerns. It already explicitly set out provision of the medical device registers and information gateway, which will allow the Secretary of State or the Medicines and Healthcare products Regulatory Agency to disclose information about medical devices to the NHS family.
Mr Tanmanjeet Singh Dhesi (Slough) (Lab)
First, I wish to pay tribute to those amazing activists, including Members of this House, who have painstakingly and persistently fought for justice, struggling to get their voices heard. Although those campaigning for the truth about the side effects of Primodos, sodium valproate and pelvic mesh repairs have been vindicated by the findings of the Cumberlege review, it is too often the case that women’s health issues appear to be repeatedly dismissed and de-prioritised, sometimes with devastating long-term effects. What will the Minister be doing to get rid of this shameful health injustice?
Ms Dorries
I thank the hon. Gentleman for his question. I am here listening to everything that everybody has to say about this report. I am working with a team to evaluate every recommendation and every aspect of the report. I think I have answered twice, and I concur 100% with his opinion that so often we fail to listen to women’s voices and fail to take them seriously, and they live with the lifetime consequences of that.
We have a number of investigations taking place. When this Government, and in particular, the Department of Health and Social Care, hear that there has been what we consider to be an issue of concern anywhere affecting women we are not afraid to investigate thoroughly. The hon. Gentleman will know that we have mentioned a number of investigations recently. The NHS does amazing work, and we go out and clap for our carers, as we have done particularly in recent months. We have an amazing NHS, but we cannot say that problems do not occur and things do not happen, because they do. There has to be a quest for constant improvement and learning. In answer to his question, let me say that the only way we can improve is by learning. We have to learn from the Cumberlege report. We will need to learn from the Health Service Safety Investigations Body—from the investigations and the learning. We have to learn from the Care Quality Commission. Learning now needs to be something where we do not apportion blame.
If we continue to have a culture where we apportion blame to hospitals and to individuals, it will be difficult always—the barriers will always be there to learning. That is how I answer the hon. Gentleman’s question and how I give my commitment—to ensure that we do not apportion blame, but we do learn and we take those learnings, that we apply them and move forward.
Dehenna Davison (Bishop Auckland) (Con)
It has been really reassuring hearing so many Members pay tribute to those who have campaigned so tirelessly for this report to be done and contributed to the report. I would like to add my own personal tribute to Joanne Bylett from Bishop Auckland, who is personally affected by Primodos. Joanne and her daughter Natalie have been amazing in their campaigning efforts, and I just wanted to put that on record. Across my constituency, there have also been women affected by vaginal mesh implants. Will the Minister continue to work with the NHS and with women who have those implants to ensure that any removals are carried out with a full understanding of what that removal will entail?
Ms Dorries
My hon. Friend raises the important issue of informed consent, which has come very much to the fore recently, including how detailed consent needs to be and how much information people need to have. Of course we are working with those women and ensuring that they have every detail and every bit of information that they require before mesh is removed so that they know exactly what operation they are undergoing. That needs to be a template for moving forward. Informed consent needs to be what we move forward with in much more detail, so patients are fully aware of the risks and benefits of any surgical procedure they are undergoing.
Patricia Gibson (North Ayrshire and Arran) (SNP)
One of the most disturbing aspects of Baroness Cumberlege’s report is the way that women have been dismissed when they report concerns and debilitating pain. This is a fundamental point in this entire scandal: as multiple studies have shown, there is an imbalance between the experiences of men and women in many areas of medicine, suggesting that a gender health gap does indeed exist, and often shows up in the misdiagnosis of women’s symptoms, while at other times it appears that their health concerns are just not taken as seriously. I have heard what the Minister said in response to earlier questions on this issue, but undoubtedly this is a systemic problem. Does she have any plans to review male bias across the NHS involving devolved Governments?
Ms Dorries
The hon. Lady is absolutely right in everything she said, and I completely agree with her, 100%. My team of officials and I, from the very first day that I arrived in the Department, have been looking at a women’s agenda and at the way that in so many areas of healthcare there does appear to be an unintentional bias. I am not saying that it is intentional and I would not particularly use the word “misogyny”, but there is an unintentional bias. It is proven by the amount of time it takes for women to have their voices heard and for their complaints to be taken seriously and yes, addressing that is absolutely a priority. The problems that women were subjected to and the prolonged pain they experienced simply because their voices were not being heard is something that we will have to address in our response. That bias against women must surely be obvious from the amount of inquiries that we are having about women-only issues, and I hope that highlighting that, bringing it here and not being afraid to ask for inquiries where we see that bias taking place, is like shining sunlight on it—to quote someone long before my time. It is only by opening up these issues, allowing a spotlight to be shone on them and not being afraid of what we find that we can go anywhere towards addressing this. We do it by establishing a blame-free culture, a bit like the airlines industry has in the HSSIB, where we look at incidents that have happened, do not blame anyone, and make sure clinicians, nurses and healthcare workers can reveal what has happened in an incident. By doing so, we can put the learnings in place to make sure that it does not happen again.
Anne Marie Morris (Newton Abbot) (Con) [V]
The report from Baroness Cumberlege is more than welcome. It demonstrates to me, and to many of us, that the key to getting this right is having the knowledge, because with knowledge we have power—the power to prevent something like this happening ever again. Only with that knowledge and that data can we ensure patient safety for the future, and safe innovation. In that regard, will the Minister consider going further than Cumberlege and the current medicine and medical devices legislation? We need a single database with all devices, not just those that are in vitro, and we do not need a web of connected databases; we need one. Also, we need this to be linked—we need information about devices and information about patient records connected, and those patient records must include primary and secondary care. I would like to see something that is truly integrated, internationally compatible and searchable, whether by universities, academics or the medical profession. I would like to see something that is state-of-the-art and internationally the best. To enable that, will the Minister create some form of protocol so that existing databases can in future be migrated into the master plan? At the moment, there is no plan for that. The concept is seen to be too difficult, but—
Mr Deputy Speaker (Mr Nigel Evans)
Order. I appreciate the importance of this statement, but please could we have shorter questions? I want to get everybody in and I think it is important that we do so.
Christine Jardine (Edinburgh West) (LD)
Baroness Cumberlege’s report is not just welcome, but blunt, both in the way it talks about the specific problems with women patients treated by Primodos, sodium valproate and mesh, and the way it talks about the systemic and cultural problems that we have, which mean that this is not the first time that we have dealt with these issues in this place. Hopefully, it will be the last, but the report does say that there is nothing that leads them to believe that this is not happening with other medications and devices. I was in exactly the position of those women who were prescribed sodium valproate, but I was lucky. I had a female GP who spotted the danger and advised me, and I was given alternative medication—taken off it completely in fact—before I became pregnant. Can the Minister assure me that from today, we will take a much more positive approach, so that as well as the recommendations, we will have some kind of strategy—a cultural approach—to getting across how important it is that these issues are dealt with when women go to their GPs?
Ms Dorries
I will try to keep my answers shorter. The hon. Lady is absolutely right. The sodium valproate pregnancy prevention programme is running hand in hand with an information awareness programme. Many GPs are aware, but of course there is still a problem and it is something that we are addressing.
Selaine Saxby (North Devon) (Con)
My constituent Diane Surman’s daughter, Helen, was affected by the Primodos scandal, and I am delighted that their circumstances have finally been recognised for the injustice that they are. Will my hon. Friend assure me that the Government will do all they can to ensure that Bayer recognises its responsibilities, apologises and contributes towards the payments outlined in the report?
Stephanie Peacock (Barnsley East) (Lab)
For too long, female patients have had crippling pain dismissed as “women’s problems”. As the Minister said, women have been failed, so can I press her further on the recommendations of this report? Will the Government appoint a patient safety commissioner to ensure that women are taken seriously and that terrible mistakes like this do not happen again?
Ms Dorries
We will be considering all the recommendations and returning to the House with a full report as soon as possible.
Fiona Bruce (Congleton) (Con)
As vice-chair of the all-party group on valproate and other anti-epileptic drugs in pregnancy, I thank the Minister for her tone today. Does she agree that it is shocking that the Committee on Safety of Medicines as long ago as 1973—this is the predecessor of the MHRA—was clearly aware of the risks in pregnancy of the use of anticonvulsants? It said that they are liable to produce abnormalities. Over that period of time, 20,000 children could have been affected. There are families, such as those of Janet Williams and Emma Murphy, who have campaigned tirelessly—I pay tribute to them too on this issue—who now have to care for those children, potentially for their entire lives. Much more support is needed for those children from local authorities and health authorities. It has not been given until now as a result of the lack of recognition of the link between, and risks of, anticonvulsants in pregnancy and abnormalities. Will the Minister, when she meets us, focus on ensuring that that issue is taken forward so that more support can be provided?
Ms Dorries
I absolutely will. My hon. Friend highlights how long it takes for women’s voices to be heard—since 1973—and I will do as she asks.
Chris Bryant (Rhondda) (Lab)
May I add Owen Smith, my former constituency neighbour, to the list of those who campaigned vociferously, in particular on mesh? Medical innovation does save lives. I have sat next to a doctor who worked for many years in melanoma, and she said that, for nearly all of her career, when she met somebody with melanoma she basically had to manage their expectations of how long they were going to live. Now, because of medical innovation, she is able to save their lives, but she can do that only if the medication being provided is guaranteed as safe.
As I understand it, nearly all the clinical trials that were started at the beginning of this year in relation to cancer have been stopped. We need to get them started again so that people can be certain that they are safe. Is it not time that doctors, instead of writing to other doctors and copying the patients in, write to the patients and copy the doctors in, so that the patient is put in control of their own treatment?
Ms Dorries
The hon. Gentleman makes an interesting point about cancer trials. He may have heard the recent announcement that one of the Nightingale hospitals is to be used for processing cancer diagnoses. I believe that cancer treatments have started again, but I will come back to him with further information because this is not really in the scope of the report.
Caroline Nokes (Romsey and Southampton North) (Con)
We have heard a great deal about my hon. Friend’s agenda for women, and I hope that the Women and Equalities Committee will have a chance to scrutinise it at some point.
I remember first meeting Emma Murphy and Janet Williams to talk about sodium valproate back in 2014. The Minister is absolutely right to point out what a valuable treatment it is, but it has massive dangers for pregnant women. She spoke of the pregnancy prevention programme, but there are drugs out there, such as Roaccutane, for which people cannot get the next month’s prescription unless they take a pregnancy test. Will she consider going further than the advice in the information that is given out to doctors and women and ensure that it cannot be given to pregnant women?
Ms Dorries
That is an interesting proposal. My hon. Friend has spoken about Roaccutane several times in the House. She makes an interesting comparison, and we will go away and look at it.
Jeff Smith (Manchester, Withington) (Lab)
This report is vindication for the campaigners, but it will also provide relief for the McLellan family and the Pierce family, constituents of mine whose lives have been blighted for decades by the consequences of Primodos. I am particularly pleased that one of the recommendations is for an ex-gratia scheme for discretionary payments to the families for their costs, but I remind the House that many of the children are now in their late 40s or 50s and the mothers are generally in their 70s. They have suffered for too long already, so will the Minister commit to getting that redress for families as quickly as possible?
Ms Dorries
As the hon. Gentleman knows, that is not a commitment that I can make here at the Dispatch Box today, but we will return to this. All the report’s recommendations are being studied. It is a deep, comprehensive, two-and-a-half-year report, and it deserves thorough analysis and a proper response. It is not for me to come here and make recommendations the next day on the back of a huge report. We only saw it yesterday, and we need to evaluate it before we can come back with recommendations.
Imran Ahmad Khan (Wakefield) (Con)
This morning, I had a moving conversation with Julie Satari, a well-loved schoolmistress in Wakefield who underwent the mesh removal procedure. In addition to the significant cost, the nature of such procedures is tortuous, both physically and emotionally. Julie told me that she, along with many others she knows, cried yesterday as she read the Baroness’s report approvingly. Julie asks, “Will Her Majesty’s Government help wipe away their tears with immediate action, not promises for the future?”
Ms Dorries
As I have just said, this is a two-and-a-half-year report: it is complex. It is a deep dive into issues relating to Primodos, sodium valproate and vaginal mesh. There is absolutely no way that I could come to the Dispatch Box today and do what my hon. Friend asks. We need to evaluate the report properly to do it justice—to do those brave women who came forward justice. As I say, we will return to the House with our recommendations and an evaluation of the reportj in full.
Andrew Gwynne (Denton and Reddish) (Lab) [V]
I welcome the Minister’s statement and, indeed, the Cumberlege report itself. The concerns we hear throughout the Chamber are justified; we absolutely have to right the dreadful wrongs of these health scandals. I pay tribute to all those groups that have campaigned for justice for so long, because women’s health issues have appeared to be repeatedly dismissed and deprioritised. The review found that research on patient safety was neither prioritised nor funded. Can the Minister explain why historically that has often been the case, and whether and how she intends that to change in future?
Ms Dorries
Apologies, but I am not sure what the hon. Member means in terms of patient safety in the past. All I can say is that patient safety is an absolute priority. My ministerial titled changed recently to Minister for Patient Safety, Mental Health and Suicide Prevention—patient safety is the first consideration in my title. I am the Minister of State for Patient Safety. That is a demonstration of the Department’s absolute commitment to patient safety going forward. It is a high priority in the Department of Health and Social Care. Everything we do in terms of health—from HSSIB and the CQC to NHS Improvement—and a number of measures that we have put in place in recent years demonstrates that commitment to patient safety. We want to make the NHS the safest healthcare system in the world. We continue to strive to achieve that.
Dr Kieran Mullan (Crewe and Nantwich) (Con)
I welcome the report and its wide-ranging recommendations, particularly those focused on a medical-devices registry and the need to improve our post-market surveillance of drugs and treatments in this country. However, I urge caution in respect of the risk of creating new posts and bureaucracy when we already have an extensive number of organisations—including the CQC, the ombudsman and Healthwatch—and hospitals themselves have a responsibility to listen to complainants, whatever the cause of their complaint might be. In my time at the Patients Association, we ran a survey of complainants across a number of hospitals to compare and pick up those hospitals that were not as good at listening as others. Does the Minister agree that, if all healthcare providers had to survey their complainants and we could compare how well providers were listening to them, we might see improvement on the frontline for patients, in respect of all different causes of complaint?
Ms Dorries
My hon. Friend makes a really important point. It is a recurring theme—over and over again—that when patients complain, the first point of complaint is to the trust where they were treated, but that is often where the logjam is. A patient-safety campaigner told me recently that it was seven years before the chief executive of a trust would even acknowledge his complaint or meet him. That is where we see the logjam happening. I will take away my hon. Friend’s point and consider it, because it is a very important one.
David Linden (Glasgow East) (SNP)
Like the hon. Member for Lancaster and Fleetwood (Cat Smith), I wish to focus on the specific issue of sodium valproate. Given that it was a UK-wide review, what discussions is the Minister having with her counterparts in the Scottish Government to ensure that we find a systematic way to identify women who are at risk—say, by way of a patient register?
Ms Dorries
Health is devolved in Scotland, of course, but we constantly have conversations with our healthcare partners across all the devolved nations.
Robbie Moore (Keighley) (Con)
I welcome the statement and the report. My thoughts are with those individuals and families whose lives have been turned upside down by these issues. Will my hon. Friend work with the Medicines and Healthcare Products Regulatory Agency to ensure that patient safety is central to its work?
Ms Dorries
Absolutely. The MHRA itself is undergoing a culture change and an operational change and is itself looking into how it responds to patients and the way it considers patient safety as a priority. I am the Minister of State for Patient Safety. Making patient safety has to be one of our No. 1 criteria in the NHS. People who come into the NHS—who come into hospitals—have an absolute right to be confident and safe. All organisations in the healthcare structure need to do the same in that respect.
Mr Deputy Speaker (Mr Nigel Evans)
I thank the Minister for her statement and for answering all the questions on the call list.