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.

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.