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Independent Medicines and Medical Devices Safety Review

Volume 804: debated on Thursday 9 July 2020

Private Notice Question

Asked by

To ask Her Majesty’s Government what assessment they have made of the report by the Independent Medicines and Medical Devices Safety Review, First Do No Harm, published on 8 July.

While the NHS is a beacon of brilliant care and safety in the majority of cases, we must do better, as this report demonstrates. I apologise in full on behalf of the healthcare system to all the families affected in this report for the time it has taken to listen and respond to their concerns. I salute their courage and persistence in coming forward to make these concerns known. Much has already changed. We are introducing major advances in legislation, but we will respond further. In the meantime, I pay tribute to patients who bravely shared their experiences to inform this important report.

My Lords, I thank the Minister for his fulsome apology on behalf of the Government to all the victims—all the women and all the families. The first duty of any healthcare system is to do no harm, and the damning report from the noble Baroness, Lady Cumberlege—whom I congratulate—into the use of these medical devices and medicines, including pelvic mesh, reveals shocking failures in this duty of care. What further urgent action will the Minister, along with his colleagues in the department of health, now take to implement the review’s nine recommendations, including a task force and an exhortation to the devolved nations to implement and act on those recommendations?

My Lords, much has already happened, and I point to the appointment of a national patient safety agency, run by Dr Aidan Fowler, whom I know and to whose fine work I bear testimony. Much is due to happen shortly: I emphasise the introduction of a registry amendment to the Medicines and Medical Devices Bill, which is due to be debated in this House shortly. But there is more to be done. The Government must consider the report’s recommendations, on which we will return shortly.

Does the Minister agree that this scandal is about something much deeper than damaging medicines and inadequate healthcare products? Just as the law for generations dismissed the experience of women who were abused and raped and gave little credibility to their testimonies, the medical profession too has to examine its own culture, which as this report shows—

My Lords, the noble Baroness, Lady Kennedy, has very bad connectivity at the moment. Can we come back to her later in the Question, if possible?

My Lords, the country owes an enormous debt of gratitude to the many campaigners who have fought tirelessly over decades to get their issues raised and to ensure that this never happens again. It is good that the Government have apologised on behalf of many Governments, and it is reassuring to hear that there will be some amendments to the Medicines and Medical Devices Bill, but the people who are affected need redress urgently. Can the Minister give us an indication of when this will happen?

I share with the noble Baroness, Lady Brinton, my personal respect and admiration for the campaigners, who are described in the report as having lived through the most awful experiences and who, through personal commitment and determination, have brought attention to these huge failures and have pursued their cause with enormous patience. We owe them a huge debt of gratitude. In terms of commitments on the individual recommendations, I have mentioned what we have done so far and what we have on the near horizon. However, it will take some time for the Government to study these recommendations—to understand from my noble friend Lady Cumberlege herself her detailed recommendations—and to come back on the timetable that the noble Baroness requested.

I will be brief; I could talk about this report for a very long time but I will not, as I am very conscious of other people who want to ask questions. I start by thanking Members of both Houses who have supported us throughout this review and indeed the report. I particularly thank the patient groups, of course. We met them on Tuesday and they were fulsome in their support for this report, which means a great deal to us. We called our report First Do No Harm because that is the principle that should start good-quality care—it is about not only doctors but the whole of the healthcare system—but too often we found that it has not.

First do no harm, but then do some good, because the report also looks to the future. Our report is comprehensive and is built on what patients and patient groups have told us. We listened to them—over 700 women and their families face to face, and many others through telephone calls and emails—we heard them, and we believed. Their stories were harrowing and heart-wrenching: the relationships that were broken, the careers lost, the financial ruin that resulted. Terrible harm has been done to them. It showed us that the healthcare system, as a system, has been failing. I am very pleased that the fulsome apologies made today by our Minister and the Secretary of State have acknowledged that.

Our first recommendation has already been fulfilled and I am sure that the patient groups will be warmed by that. I ask my noble friend the Minister: will the Government seriously study our nine recommendations? Some are about the current situation, some the future. They are all really important. The patient safety commissioner is a new idea and Jeremy Hunt, who commissioned our report, has described it as a very bright and good idea to have someone who will fill the gaps that we have found in the whole of the healthcare system. Will the Minister please ensure that our recommendations are implemented? Implementation is key. We do not want this report to sit on a shelf and gather dust, though I am sure that the patient groups will not allow that to happen. It is really up to the Government to grip this issue and make a real difference in the lives of so many people, suffering not only now but in the future. Will he ensure that the patients, who are the experts, will be closely involved in the implementation group—the task force? Will he recognise the knowledge and experience of the task force? Can he also ensure that the experience of the review team, which has worked so hard, is included?

My noble friend Lady Cumberlege has put it incredibly well and I endorse her testimony about the courage and expertise of the patient groups who informed this report. I am only sad that they cannot be here to share this important moment. I pay tribute to the work of my noble friend and her team working on this. Patient safety is uppermost now in the mind of health carers. She is absolutely cutting with the groove. The words of Jeremy Hunt are very well made, and we are utterly committed to looking seriously at these recommendations.

My Lords, I add my apologies to the patients and their families and acknowledge the superb work done by the noble Baroness, Lady Cumberlege, and her team. The report makes very salutary reading. Are we going to make sure that we keep central records relating to any type of implant in future, including mesh used in hernias, so that we can follow up individual cases as appropriate? Will the Government consider returning to the Health Service Safety Investigations Bill, which was delayed and abandoned as a result of the recent general election?

Health records are absolutely key—that is why we have tabled an amendment on them. That amendment enjoys the support of the Government and of me personally.

I think we can see that we need a longer discussion on this report. It is quite clear that some of its excellent recommendations will require primary legislation and I hope the Minister may have identified them already. We on these Benches are keen to co-operate with the Government and across the House to bring forward the necessary amendments to the Medicines and Medical Devices Bill.

The HSSI Bill is an incredibly important part of our agenda. It is not currently on our schedule, but we hope to bring it back at some date, or incorporate its contents in another vehicle.

I call the noble Lord, Lord Willis of Knaresborough. No? In that case, I call the noble Lord, Lord O’Shaughnessy.

My Lords, as a former Health Minister I add my apologies to these women on behalf of the Government I served. They were let down over many years and I pay tribute to their courage in coming forward for this review. I also pay tribute to my noble friend Lady Cumberlege and her review team for a superb, landmark piece of work. I want to press my noble friend the Minister on one issue: he mentioned that Aidan Fowler is the national director of patient safety in NHS England. That is quite right and very welcome, but the report recommends that somebody from outside the system—someone whose first loyalty is to patients themselves, not to the NHS—should be the gateway, the representative on behalf of patients. I know my noble friend wants to consider these recommendations carefully, but will he not rule out the idea of a new, patient-focused commissioner simply because there is someone leading on patient safety in NHS England already?

I thank my noble friend for his comments and for his role in commissioning this important report. His point on the safety commissioner is extremely well made. I am not ruling out anything whatever, but we need time to study the report before we can make any commitments.

My Lords, I thank the noble Baroness, Lady Cumberlege, and her team for what is a hard-hitting report, and rightly so. Reading it, I felt anger and shame—anger that so many women patients were treated with such disdain and felt that they were not listened to; and ashamed that members of a profession I belong to showed such ignorance, arrogance, duplicity and callousness towards the very people who put trust in them. As a member of that profession, I apologise wholeheartedly to women who suffered and I hope that the profession takes heed of them. Much of the report draws on narratives from women, and I was struck by one who called herself

“an unsuspecting, unwilling participant in a cruel experiment”.

No patient should ever feel that. I hope this report is a wake-up call for the professional organisations too, to take charge and become more patient-focused, rather than professional-focused, and to deliver the care that patients deserve. I am a long-time supporter of the charity Epilepsy Action. It has welcomed the report and hopes that action will be taken soon, particularly for women and mothers in relation to sodium valproate. I support the questions asked of Ministers and I hope we will soon see action.

My Lords, no one who reads the report can help feeling anger and shame; the noble Lord puts it well. I completely endorse his feelings and the Government will be looking at these recommendations closely and acting on them in the spirit he describes.

My Lords, I ask this question on behalf of some of the women campaigners. The report states:

“The removal of transobturator tape is technical and complex surgery and there are very few surgeons in the UK capable of undertaking this”.

While this remains the case, will the Minister consider banning these mesh tapes until women can be sure that any post-operative problems can be fully and safely treated?

My Lords, one cannot read the descriptions of the consequences of some of the surgery around mesh, and the pain and suffering that some of the women endured, without feeling huge anger and shame and instinctively wishing to ban such a thing. However, mesh offers a solution to some women whose prolapse is profound and who have run out of options. There are women for whom mesh has been a great saving and where there has been a successful procedure. Procedures around mesh have improved dramatically. We are reluctant to apply a blanket ban, but we take the recommendations of the report very seriously and will be looking at this procedure extremely closely.

Sitting suspended.