Independent Medicines and Medical Devices Safety Review

Jim Shannon Excerpts

Thursday 8th July 2021 Commons Chamber

[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.

--- Later in debate ---

[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.