Cumberlege Report

Hannah Bardell Excerpts

Thursday 3rd February 2022 Westminster Hall

[Alec Shelbrooke]

That is where we have to dig into recommendation 4:

“Separate schemes should be set up for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim”.

The Government do not accept recommendation 4. That is exactly the same situation as with thalidomide. One of my earliest campaigns in 2012 was to extend the grant to victims, and my hon. Friend the Member for North Dorset (Simon Hoare) took that campaign further to make it a permanent grant. People will not recover from what happened, whether it was drug-induced or operation-induced.

My constituent who has had mesh removed emailed me only today to say that four years down the line things are better, but they have not improved to the point where she can really live her life. She says she is mentally exhausted and does not want to go on. She had a thriving physiotherapy career that she cannot go back to. She is only in her 40s and has the rest of her life to live. The Government have a responsibility because the Government run the NHS. I interchange the words “NHS” and “Government”, but the NHS is the Government. That is where this situation falls on the Minister:

“While the Government are sympathetic to the experiences of those patients who gave evidence to the report, our priority is to improve the future safety of medicines and medical devices.”—[Official Report, 21 July 2021; Vol. 699, c. 72WS.]

Trying to prevent further catastrophe is obviously very important—that is one thing—but thousands of people will suffer for the rest of their lives thanks to this treatment.

I will draw the distinction between this surgery and breast-enhancement surgery. Many people have had that done privately and then when there have been complications, they have had the operation to sort it out on the NHS. There is often a lot of debate around whether that is right or wrong. That is not where I want to go today. However, if we are willing to do that for things that people have had done privately, why are we not willing to redress the issues of people who have had things done by the NHS?

We are talking about women from their teens all the way up. Some people think the problem is with the elderly end of the population, but we are talking about those in their teens upwards. As I said, we did recognise the situation with thalidomide. I know that costs come into it, but there is a moral responsibility to redress the situation.

[Hannah Bardell (Livingston) (SNP)]

The right hon. Gentleman is making a powerful speech. Does he agree that there is a moral responsibility? Once the Government—whatever Government that is and wherever they are—have committed to review such a profound issue, and have essentially marched people up to the top of the hill, giving them faith and hope, they must then follow through. Leaving people in a state of suspended animation for such a long time, when they have already suffered so much, is just not acceptable.

--- Later in debate ---

[Hannah Bardell (Livingston) (SNP)]

It is a pleasure to serve under your chairmanship, Sir Graham, and to follow the right hon. Member for Romsey and Southampton North (Caroline Nokes). She summed up so well the concerns and the frustration that so many of us have. I pay tribute to my right hon. Friend the Member for Elmet and Rothwell (Alec Shelbrooke)—I call him that because we have worked so closely on so many of these issues. He spoke with such passion and in such detail about all these issues: about the impact on women and their families from mesh, from sodium valproate and from Primodos, which is what I will focus on while summing up the debate on behalf of the SNP.

My constituent Wilma Ord and her daughter Kirsteen were the very first constituents who came to see me after I was elected in 2015. I cannot believe that I am standing here today, alongside colleagues who were elected at various times, having challenged the Government and asked for action in 2015, in 2016, in 2017, and so on and so forth; for my part, I have been challenging them through three elections now.

As I said earlier, we have marched campaigners and victims to the top of the hill and put them through the trauma and frustration of the expert working group, which the right hon. Member for Hemel Hempstead (Sir Mike Penning) so poignantly discussed. I remember going over the road to the conference centre with the hon. Member for Bolton South East (Yasmin Qureshi) to challenge the expert working group, which was essentially a whitewash and a big fat waste of public money.

We do not want the incredible work of Baroness Cumberlege to be another waste of public money, and it is clear that it is not. All her recommendations are so important. An article in The BMJ in 2020 highlighted that the Cumberlege review exposed

“stubborn and dangerous flaws in healthcare”

and a healthcare system that is

“disjointed, siloed, unresponsive, and defensive.”

We must recognise the incredible work that the NHS does, but where there are flaws and where harm has been done, that must be fixed. Some things have struck me in particular about culture and harm, the litigious nature that I think has developed within some elements of the Government, and the unwillingness just to accept when wrong has been done and to see the human cost of it. The human cost to my constituent Wilma Ord and her daughter Kirsteen is just incredible, as it is to campaigners such as Marie Lyon, who has been campaigning for 40 years. She has spent four decades dedicating her life to the campaign, but she has not seen any progress other than these reviews and reports. Those are very important, but she has not seen justice and she has not seen change.

Members from across the House have mentioned the Government’s statement that there is no need for a redress agency because they have the levers and the tools. This is somewhat of a tangent, and we know that such cases are very rare, but a constituent came to me recently about the impact on them of one of the covid vaccinations. I commend the Government for putting in place redress for those who have been impacted, but I found out recently from answers to my written questions that that system has not yet paid out anything to anybody. That is proof that while there may be good ideas, they are not being followed through. A redress agency is crucial to ensuring that we make improvements and that our constituents’ lives are not damaged and dogged by such profound issues.

My constituent Wilma Ord’s medical records have a gap between 27 November 1968 and 27 January 1971, but we know that she was pregnant because she gave birth to a baby, Kirsteen, who was born with cerebral palsy and suffers from deafness. Wilma is not alone among woman who were pregnant at the time in having suspiciously missing GP records. That is a mystery that many women have had to face, and I have seen written evidence to prove it. A document dated 13 March 1964 clearly states that GPs who were worried about adverse reactions would be best to destroy any evidence of records to protect themselves, and I quote, “however wrong” that may be. Schering, the drug company that is now Bayer, sought legal advice way back when it was told it would more than likely be found guilty of negligence by a trial judge.

Marie Lyon and others have had access to these documents, as has Baroness Cumberlege, who recommended that the families who suffered avoidable harm ought to be given redress because there is a strong ethical responsibility to do so. We have heard time and again from Members across the political spectrum how important that redress is. It is surely the first and last duty of a Government to look after their citizens and, where harm has been done, to find redress and do everything in their power to make sure that harm is not done in future.

My constituent Wilma Ord has often said to me that someone who did this or has the power to affect change should walk a day in her shoes, feeling and seeing what it is like for her daughter to be unable to live a normal life. She has had a job but was bullied for being different, and no efforts were made to accommodate her deafness. I would like to think that the world and our society has moved on significantly, but Wilma feels very strongly and has expressed to me directly that it was her fault. It is important that we send a clear message today to all the victims of sodium valproate, mesh and Primodos that it was not their fault and that they are not responsible.

The right hon. Member for Maidenhead (Mrs May) spoke about the culture that still exists within healthcare today. It discriminates against women and makes them feel as if they are imagining things. It is literally gaslighting them. The wait for redress has gone on far too long. Members have spoken so passionately today, but how often are we going to have to debate these issues over and over again before the Government simply accept the recommendations and put them in place?

Mention has been made of the legislation passed in Scotland. The hon. Member for Chesham and Amersham (Sarah Green) did not feel that it had gone quite far enough, but I hope that it has gone some way to redress. We have appointed a patient safety commissioner. We are also quite well on with our women’s health plan. I say this not to in any way bash the UK Government; we are doing very similar work. We might be a bit further ahead, but I hope that our Government and the UK Government can work together on this, because I think many learnings can be shared.

Members have said that it is not the Minister’s fault—that she is just doing her duty in delivering the lines of Government—but please listen to us. Please listen to our constituents’ concerns. Do not make them wait for more decades. Let us try to draw a line under a culture that puts the desires and views of lawyers before people’s lives. That is what we are talking about. My constituent and other victims of Primodos were used as human guinea pigs. That is not acceptable. We need to send them the strong message that we stand with them, but we need every Government across the UK to do everything they can to see redress and to see the Cumberlege report implemented in full, so that victims can be at peace and have the redress that they deserve.

--- Later in debate ---

[Maria Caulfield]

Valproate should not be being used on women or girls able to have children, unless they have a pregnancy prevention programme in place. That is to ensure that patients are fully aware, if they need to take sodium valproate, of the effect on any potential pregnancy. The NHS also commissioned the paediatric neurosciences clinical reference group to support the development of pathways for care services, specifically to improve patient support and co-ordination on the pathway for sodium valproate.

Mechanisms are therefore being set up for those women and girls who need to take sodium valproate. I think my right hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) pointed out that, in other settings, a huge amount of work is done to ensure that those women do not get pregnant. Also, a multidisciplinary expert group with experience in responding to exposure has been established. It will report its recommendations to NHS England in March this year. We will follow up on those recommendations, but a piece of work is being done specifically on sodium valproate, which will help to prevent such problems in the future.

Recommendation 6 was on MHRA reform. The review highlighted the need for the regulatory agency to undergo substantial revision, in particular on adverse event reporting and patient engagement. As many Members said, instances were flagged many times by many different people—the women themselves, MPs in this place, charities and other bodies—but people did not listen, although the MHRA has a duty to do so.

The MHRA has now initiated a substantial programme of work to improve how it listens and responds to patients and the public, developing a much more responsive system for adverse event reporting and supporting timely and robust decisions involving patient safety. It has been consulting on a new regime for medical devices that makes patient safety, engagement and transparency more prominent.

To strengthen its commitment to patient engagement, the MHRA recently established an enhanced customer service centre to make it easier for patients to express concerns, whether about medicine or devices that are being used. The MHRA has also appointed a chief safety officer, Dr Alison Cave, who will lead its ongoing commitment to the recommendations.

On setting up a database to collect details of all implantations of devices, which is recommendation 7, we have already legislated for that through the Medicines and Medical Devices Act 2021. The Act created a power for the Secretary of State to regulate for the establishment of a UK-wide medical device information system. Alongside developing those regulations, more than £11 million has been set aside for the work, involving partners across the healthcare system to scope, test and cost options for that workstream.

On transparency for payments, which I think was raised by the hon. Member for Chesham and Amersham (Sarah Green), who spoke about the conflicts of interest between doctors and pharmaceutical companies or providers of surgical mesh, recommendation 8a highlights the need for greater transparency for payments made to doctors. The recommendation calls for a register of doctors’ interests and for recognised and accredited specialisms to be held by the General Medical Council.

As the Government set out in our response to the review, we agree that lists of doctors’ interests should be publicly available. We continue to hold the view that that information will be most accessible to patients if it is published by healthcare providers rather than by the GMC. We are taking that measure forward and it should be in place by July this year.

We are also working with professional healthcare regulators to be clear that all regulated health professionals—not just doctors—must declare their interests, and that that information must be published by their employers. That approach will give not just women but all patients the reassurance that there are no interests involved in clinical decisions made about their care. We are working with the Care Quality Commission and equivalent organisations, and with the devolved Administrations, to ensure that implementation is monitored and that there is local accountability.

Recommendation 8b touches on the mandatory reporting of the industry. It calls for the pharmaceutical and medical devices industries to establish payments made to teaching hospitals, research institutions and individual clinicians. On 24 January this year—just a few days ago—an amendment to the Health and Care Bill was tabled to give the Government the power to deliver on that important recommendation. That legislation will, I hope, come into law fairly soon. The amendment will enable the Secretary of State to make regulations requiring companies to report information about their payments to the healthcare sector. That measure will benefit patients, who will see payments made to their doctors or hospitals, and it will build on proactive initiatives by healthcare regulators and the industry.

I very much take on board Members’ feeling that it took too long to acknowledge the problems that those women have faced, whether because of mesh implants, sodium valproate or Primodos. Although this may not be of any reassurance for women who have already been affected, we now have measures in place to flag problems in the system. For maternity care and clinical negligence, for example, we have an early notification system so patterns of events around neonatal care and foetal abnormalities are picked up at an earlier stage, to get on top of the causes quickly. We are seeing improvements in maternal and neonatal outcomes as a result of that early warning notification system

We very much recognise that such problems did happen in the past, but measures are being put in place to make sure that they do not happen in the future. I certainly want to make sure that the women affected are getting the care and support that they need. I very much take on board the points raised by hon. Members. I am very happy to keep Members updated on progress. I meet Baroness Cumberlege regularly to address the issues raised in her report.

I reassure colleagues that many of these issues will feature in the women’s health strategy, which we will publish shortly. The women’s health ambassador, the patient safety commissioner and I will be working hand in glove to make sure that women’s voices are heard in relation to their healthcare, and that we end the pattern of women feeling that they are not being listened to, that they are palmed off, and that their concerns are not taken seriously.

[Hannah Bardell]

Does the Minister recognise that this is not only about compensation, but about exposing the failures so that they never happen again? Eighteen members of the Primodos support group have died in the past two years. That gives an idea of just how long people have waited. They should not have to wait any longer. Those who have died will never see justice.

[Maria Caulfield]

I absolutely take that point—that is the crux of the matter. For too long in the health service, there was no duty of candour. The health service did not acknowledge when mistakes were made. That is changing; there is now a duty to declare when a mistake has happened. There is also support for staff. I cannot remember who mentioned the whistleblower on Primodos, but there is protection for whistleblowers now. There are freedom to speak up guardians to support whistleblowers in the workplace, and the Care Quality Commission is happy to take notification from patients and staff if there are worries about unsafe patient care. That will trigger an unannounced inspection to look at the data. It is all about creating a culture of learning in the NHS, rather than one of blame that pits patients against clinicians—that is what we want to change. That is how we learn from the mistakes of the past and prevent mistakes in the future.