Independent Medicines and Medical Devices Safety Review

Baroness May of Maidenhead Excerpts

Thursday 8th July 2021 Commons Chamber

[Mrs Theresa May (Maidenhead) (Con)]

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.

I have to say to the Minister that sadly such an approach is perhaps not unexpected by Members of the House. I am sure that other Members will, like me, have had constituency cases in which there has been a problem with the treatment an individual received from the NHS, and they want an apology and to know that someone will ensure that it does not happen again to somebody else, but they come up against a brick wall, because the natural inclination is to defend the institution, rather than address the issue that has been raised.

[Jim Shannon]

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.

[Mrs May]

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 Government have agreed to set up an independent patient safety commissioner—partly, I have to say, because of the action in the House of Lords in relation to amendments to a Bill—and they are now consulting on the position, but we do not know when the commissioner is going to be in post. The commissioner is important, because it is the commissioner who will enable the user’s experience—the patient’s voice—to be heard. By hearing that voice, it will be possible to detect and stop the use of medicines and medical devices that lead to avoidable harms.

[Hannah Bardell]

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?

[Mrs May]

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.

My final point relates to sodium valproate and it partly comes from constituency experience. This medicine has a one in two risk of causing harm to a baby if a woman is taking it while she is, or becomes, pregnant. What lies behind this issue is information and education, but it took a year for the Government to write to women to raise awareness of the risk. I hope that the Government do not think that that is job done, because this is an ongoing issue that has to be addressed. It is not just about providing information to women; it is also about ensuring that their clinicians are well informed when they are prescribing and dealing with their cases.

Women suffered considerably from the use of pelvic mesh, from hormone-based pregnancy tests, predominantly Primodos, and from sodium valproate, but they and their children are still suffering today. At the heart of this situation lay a health system that, in the words of the report, is

“not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that.”

The system did not listen. It saw real pain and debilitation as women’s problems. The service which at its heart has our safety and protection ignored concerns over safety for too many years. The independent report recommends steps for the system to change. I urge the Government to embrace the recommendations in full. That way, we will be on the way to ensuring that we have a system that genuinely first does no harm.