Independent Medicines and Medical Devices Safety Review

Emma Hardy Excerpts

Thursday 8th July 2021 Commons Chamber

[Emma Hardy (Kingston upon Hull West and Hessle) (Lab)]

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”.

[Sir Charles Walker (Broxbourne) (Con)]

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.

--- Later in debate ---

[Emma Hardy]

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.

[Jim Shannon (Strangford) (DUP)]

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?

[Emma Hardy]

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.

[Hannah Bardell (Livingston) (SNP)]

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.

[Emma Hardy]

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.

The roll-out of the medical device information system has begun, but questions are arising as to what data is being collected. This is really important. To give an indication of that, let me raise the case of Kath, an extremely fit and healthy woman who used to be interested in skydiving. She had mesh implants and afterwards was in such pain that she was unable to move or get out of bad. This completely changed her life forever. However, her procedure was recorded as a success because she no longer had incontinence and that was the measure being looked at. We need to be looking at all patient outcomes when we are recording that data in those data sets.

That brings me on to my next point, which relates to the current moratorium on using mesh, as recommended in the report. Kath has said that there is no way she would ever have had this procedure had she had any indication of the risk of harm. I understand that there is pressure from some of the surgeons to reintroduce mesh, but I do not believe we can do that without fully informed consent, and we can have that only if patients are fully aware of all the risks. They can be fully aware of all the risks only if all the data is collected and recorded accurately. Until that is done, we cannot have informed consent and we should not consider lifting the moratorium on the use of mesh implants.

[Alec Shelbrooke (Elmet and Rothwell) (Con)]

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?

[Emma Hardy]

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.

[Dr Julian Lewis (New Forest East) (Con)]

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.

[Emma Hardy]

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.

--- Later in debate ---

[Ms Dorries]

I apologise, but I cannot answer the question.

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

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

[Emma Hardy]

Will the Minister give way?

[Ms Dorries]

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

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

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

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

Some Members said that none of the recommendations have been implemented or that we have not paid attention to them. That is simply not true. Recommendation 2 was on the establishment of a patient safety commissioner. I happen to know from discussions with Baroness Cumberlege that it was a prime concern for her that we established that role. As part of the written ministerial statement that I published in January, I announced that the Government had tabled an amendment to the Medicines and Medical Devices Bill before the Christmas recess to establish the role of an independent patient safety commissioner in line with recommendation 2. That is now in law under the Act. The commissioner will promote the safety of patients who use medicines and medical devices by ensuring that the views of the wider public about them are heard. There would be absolutely no point in having a patient safety commissioner if the role was not fully independent. That is what we are working on putting in place now. A public consultation is currently open and running until 5 August. I urge all Members who have spoken today and have constituents who have been affected to respond to that consultation to make sure that their views are known.

Recommendation 5 was on specialist centres, which are in place. There are eight specialist centres, and another will be opening in the south-west of England very shortly. Recommendation 6 was on reform of the Medicines and Healthcare products Regulatory Agency. I have announced that the MHRA has begun a substantial programme of work to improve how it involves patients in all aspects of its work to reform the system. Recommendation 7 was on establishing a medical device information system, again through the Medicines and Medical Devices Act 2021. In line with Baroness Cumberlege’s recommendation, this will mean that the NHS can track patients’ outcomes and spot issues. Work is under way to build, test and cost options on how a medical device information system could be embedded into the UK healthcare system.

Turning to the recommendations that we do not accept, I was honest when I stood here and said how desperately sorry I was and how harrowing those stories were, and I am not going to stand at this Dispatch Box and say that we are reviewing all the recommendations, which is what has happened in the past. I will be honest: we are not going to accept the redress agency in recommendation 3, or the taskforce. No Government have ever asked someone to chair or undertake a review and then asked those who conducted the review to implement the recommendations on behalf of the Government. That has never happened before. It is the responsibility of the Opposition to hold me to account and it is our responsibility as Ministers to implement the recommendations that the Government see fit to implement.

The Cumberlege report is a document that vividly shows the importance of patient safety and of listening to women. It is incredibly important that we listen to women. I am delighted that many people today have highlighted the adverse situations that many women experience, suffer and have to endure because they are women. It is absolutely right to say that many women are not listened to, and the hon. Member for Central Ayrshire (Dr Whitford) also made that point. This was the substance of the report by Baroness Cumberlege. Women are not listened to, and they have not been listened to. The women’s health strategy was not a recommendation but it was seriously influenced by Baroness Cumberlege’s review. That is why I established the women’s health strategy, and 112,000 women responded. It was not one of the recommendations, but we implemented it because women’s voices have to be heard.

[Emma Hardy]

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

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

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

Question put and agreed to.

Resolved,

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.