Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

[Lord Ribeiro (Con) [V]]

My Lords, it is a pleasure to follow the noble Baroness, Lady Finlay, who made a powerful case for knowing what happens to medical devices once they have been inserted. This was at the very centre of the Cumberlege review and to which I am sure my noble friend will draw our attention again, as well as to the key findings in this respect. Amendment 86 draws attention to the need for unique device identification information to be added to all packaging of medical devices, while Amendment 88 deals with the tracking of devices once inserted, as Clause 13(1)(h)(ii) requires information relating to the use of medical devices in individual procedures to be tracked and entered in a register or within hospital episode statistics data.

In my speech at Second Reading, I referred to Scan4Safety, which the noble Baroness, Lady Finlay, has just noted. In 2016, the Department for Health and Social Care awarded a total of £12 million to six hospital trusts in England for Scan4Safety demonstrator sites to investigate how the consistent use of point-of-care barcode scanning might improve efficiency and safety within the NHS. The noble Baroness also outlined the benefits of the GS1 barcodes. The result of the GS1 is a comprehensive, real-time view of stock, including that which is about to expire, as well as a complete audit trail. An audit trail is key to identifying problems with devices when they occur and to keep track of them in the future, as it may be many years before complications occur. Total hip replacements are one example. I have two of them, so I have a vested interest in knowing about the long-term future of those prostheses.

In June 2020, Scan4Safety published a report entitled A Scan of the Benefits. It gave two examples that are worthy of note and of repeating. In the North Tees and Hartlepool NHS Foundation Trust hospital orthopaedic department, barcodes helped to ensure that the correct patient is listed for the correct operation on the correct side. All items and implants are scanned before use. If the incorrect prosthesis is selected, for example a right knee implant for a patient who is supposed to be having an operation on the left knee, the barcode scanner buzzes and flashes, immediately notifying the potential error. At Leeds Teaching Hospitals NHS Trust, following the introduction of Scan4Safety, the average time taken to recall a product has fallen from 8.33 days to less than 35 minutes. The organisation reported £84,411-worth of staff efficiency savings on recall between January 2016 to December 2017 alone.

In Clause 16 on information systems, while I welcome the provisions, surely they are worthy of being strengthened by not using “may” so often. We need to move away from “may”, and its implied “perhaps”, to “must” and the implication that it will actually happen.

I shall end by restating my comments at Second Reading. The Government must undertake to mandate the tracking of all medical devices that are used in the UK, rather than a select few. I hope that these amendments will provide a means to do so. The Cumberlege review rightly recommended that a central patient identifiable database should be created, collecting key details of the implantation of all devices at the time of the operation. In the light of this, we strongly urge the Government to apply the powers provided for in Clause 16 as well and as widely as possible.

To give assurances in the context of this amendment, the Royal College of Surgeons believes that the Government should publish their intended regulations under Clause 16 in draft before Report, as they have for the various regulations on medicines. Early sight of the regulations would establish whether the Government intend to apply the powers covered by Clause 16 widely enough to satisfy the recommendations of the Royal College of Surgeons and those of the Cumberlege review.

In closing, perhaps the Minister would update us on the future of the medical devices information system and its application to the private sector.

[Baroness Cumberlege (Con) [V]]

My Lords, I very much appreciate the support that I have already received today from the noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro. I am going to go into a bit of detail on what we found during the review, but I want to say to both noble Lords that I strongly support their views on Scan4Safety. Indeed, I spent a day in Derby going through the whole process with the clinicians, support staff and policymakers, and it was very impressive.

The noble Baroness, Lady Finlay, is absolutely right to say that we should look at more than just one example. Her research, which she has told us all about today, took on the six different areas, which is excellent. However, I agree with her that we should think seriously about introducing this system across the country.

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

Taking these amendments together, we seek to make the UK an innovative and safe marketplace for trialling and developing medicines and medical devices. I believe these objectives are entirely consistent with those of the Government as described by the Minister. I hope that the Government will look very carefully at these amendments, which have been drafted with the support of the esteemed medical Royal Colleges that I have mentioned. I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, I will speak briefly in support of Amendment 84 in the name of the noble Baroness, Lady Finlay. I also wish to raise a question on Amendment 97 in the names of noble Lords, Lord Kakkar and Lord Patel, and to ask the Minister a question on equivalence, of which I have given him notice.

During my review, we heard much that greatly concerned us about the way that medical devices reach the market. Our focus was on pelvic mesh, but similar concerns apply to devices more generally. When mesh for stress incontinence and pelvic organ prolapse first came into use, the safety data available was woefully inadequate. It relied on very short-term studies, often funded by manufacturers with vested interests, with limited follow-up. Mesh is a product that is designed to remain inside the body, which presents a problem, because it is designed not to be removed. Removal can be done, on rare occasions, but it is very difficult and dangerous. Implanting a device such as this into so many patients with such a lack of safety data is, as we said in our report, foolhardy.

I recognise that some risks of new treatment options may become apparent only when they have been in use for some time. I agree with the noble Lord, Lord Hunt, that surgeons need to be able to offer new, innovative treatments. That is how medicine has made such tremendous progress in our lifetimes. We must not stifle innovation, but we must do all we can to improve patient safety and to prevent avoidable harm. We had a full discussion of this on our previous day in Committee.

In clinical trials of medicines all adverse events are reported, whatever their cause, and that is good. In the case of mesh, if selected cohorts of patients had undergone enhanced reporting, it is most likely that the adverse impacts we heard about would have been detected sooner. Thousands of ruined lives, in this country alone, could have been avoided.

In the field of medical devices, better, more thorough trials with long-term follow-up are vital, but they are not the whole answer. We also need transparency. It is one thing for trials to be conducted, but quite another to ensure that the findings they produce, and the concerns they may give rise to, are made available to the public and to potential patients. Patients have the right to know about trial outcomes and safety concerns that arise in trials. They have the right to know who is conducting the trial and who is funding it. Without that knowledge, there cannot be an informed decision about an individual’s treatment options.

Many common themes arose during our review, but one that is particularly powerful, and relevant to today’s discussions, is the phrase that so many women with terrible mesh complications used. They said to us: “If only I had known”. If only they had known the risks, perhaps they would never have had the procedure and their lives—and those of their families—would not have been ruined.

This amendment would ensure that medical device trials are entered on a publicly available database and would bring devices into line with medicines. This is much needed, which is why I support the amendment.

I turn to Amendment 97, proposed by the noble Lords, Lord Kakkar and Lord Patel. One of the issues that we encountered during our review was that the full safety implications of an implantable medical device may become obvious only once the device is inserted. Some women told us that they sensed immediately that something had gone wrong; for others it was not until years later. Trials need to be sufficiently long term to detect safety concerns some years after the device is implanted.

--- Later in debate ---

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I have received a request to speak after the Minister. I call the noble Baroness, Lady Cumberlege.

[Baroness Cumberlege (Con) [V]]

My Lords, it has been a really interesting debate. One of the things that I have found so wonderful in this House is all the professors. I did not go to university and, when I listen to the professors and the way they care for their students—and in this case I am something of a student—I really value it. I thank the noble Lord, Lord Patel, for pointing out the dilemmas that we face. They are very difficult. I am sure that the Minister also feels that: it is how you balance what we are trying to achieve as a successful United Kingdom in innovation, marketing and all the rest of it, and the dilemma of safety as well.

I thank the noble Lord, Lord Kakkar, very much. I need to read very carefully in Hansard what he said and then come to some conclusions. I am not sure that we have quite cracked it, but I believe we are working towards it. The noble Lord, Lord O’Shaughnessy, had some really interesting ideas about how we can take this forward, and we need more work to be done on it.

I want to say one thing. In the review, we were so horrified by the stories that we heard that we said we had to do something to prevent further surgeries taking place in women who were suffering so deeply. We called it the pause; we went to NHS England and the department and very quickly they agreed to our pause, with six safety conditions that had to be introduced if it was to be lifted—and, of course, they still have not been introduced. That was in July 2018.

The interesting thing about the pause is that, because surgeons were prevented from using what they would see as the normal solutions to stress urinary incontinence, with pelvic mesh, they started to think of different ways in which to do things and help women, ensuring that the discomfort that they had through these conditions was ameliorated. We are getting innovation in a very interesting way. I am convinced that such innovation would not have taken place if we had not introduced the pause. But it should not have been us, the review team, who introduced it. It should have been the healthcare system, which had put forward some measures and thoughts about it years before, but nothing happened. Of course, that was one of the burdens that I carried throughout the review—that promises were made and nothing happened. We called the healthcare system glacial; it just did not move. There are some hugely bright people in this country and throughout the healthcare system and beyond, in universities and everything else. Surely, if we could only utilise the wonderful brains that we have in this country, we could do much better.

I thank my noble friend for the very full summing-up today. The categories of risk relevant to devices have been so badly used in the past in terms of how pressure has been put on to change the risk when people knew that harm was being committed. We have a meeting with the MHRA, and I am sure that a lot of these issues will be discussed.

I thank the noble Lord, Lord Hunt, for introducing the amendment. It is very difficult to pick up somebody else’s work, but he did it with his usual tremendous skill.

[Lord Bethell (Con)]

I completely endorse the words of the noble Baroness, Lady Cumberlege, about the failings around some of the medical device regulatory regimes, which failed to pick up many of the problems with mesh. I am grateful for the interventions from the review team on that matter.

I remind noble Lords that the Bill seeks not to lay down the policy on what precise regime will suit the future of medical device regulation but to set up the framework in which those regulations are put together. The Bill meets the need on that matter. I cannot urge enough how important it is that we get the Bill on the statute book as soon as possible.

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Lord Sharkey (LD) [V]]

I shall speak briefly to Amendments 9 and 13. I should start by saying that I enthusiastically support Amendment 8, moved by the noble Baroness, Lady Thornton. We all know that the phrase “have regard to” lacks any real force. Like her amendment, our Amendments 9 and 13 are intended to strengthen Clause 1(2), whose opening words read

“In making regulations under subsection (1), the appropriate authority must have regard to”,


followed by a list of the things to which it must have regard. Amendment 9 would change those opening words to read, “In making regulations under subsection (1), the appropriate authority must have regard to, and in the case of regulations not subject to section 42(6), (7) or (8), must publish with the draft regulations an assessment of their impact on,” and then the list of things to which regard must be had.

Clause 42(6), (7) and (8) are excluded because they contain urgency provisions and may now anyway make use of the “made affirmative” procedure. The purpose of the amendment is to ensure that there must be a full assessment of the impact of any regulation on the three specified areas. This applies to all three of the areas and is of particular importance in the assessment of safety and how it is to be prioritised, in subsection (2)(a).

Amendment 13 addresses the issue of assigning priority to the safety of human medicines, as do other amendments in this group. It would rewrite subsection (2)(a), so that instead of reading,

“the safety of human medicines”,

it would read “the priority of ensuring the safety of human medicines”. Other noble Lords have tabled amendments suggesting different ways of ensuring this priority and I look forward to hearing their contributions. But whatever the variations in approach, it is obvious that a strong, clear and unambiguous statement of the priority of the safety of human medicines needs to be inserted in the Bill.

[Baroness Cumberlege (Con)]

I shall speak to Amendments 10, 12, 74 and 75 on the second Marshalled List, and I thank the noble Lords who have supported these amendments—the noble Baronesses, Lady Burt of Solihull and Lady Hollins, and the noble Lords, Lord Patel and Lord Hunt of Kings Heath.

This Bill chimes perfectly with the review that I led into two medications and a device. The review culminated in the report First Do No Harm, which states:

“Innovation in medical care has done wonderful things and saved many lives. But innovation without comprehensive pre-market testing and post-marketing surveillance and long-term monitoring of outcomes is, quite simply, dangerous.”


In conducting the review over two and a half years, my team and I listened to hundreds of women and their families, with their stories of anguish, acute suffering, destroyed relationships and parents whose children have been harmed, deformed and had their potential lives ruined.

I have been told that this Bill is not a safety Bill. If it is not, what is it, for goodness’ sake? How can safety not be the overriding purpose of the Bill? My modest amendments, and those of other noble Lords, seek to make it so.

In paragraphs (a) to (c) of Clause 1(2), safety is not the primary consideration but is on an equal footing with the availability of medicines and the UK as an attractive place in which to conduct clinical trials and the supply of medicines. These aspirations are of course important but in the way in which the Bill is drafted safety is simply an “also ran”. It should not be; it should be of overriding importance. As the noble Lord, Lord Patel, said in his amendment on the first day of Committee, the construction of this clause needs improvement.

My review found safety seriously wanting. We were commissioned to review two medications given to women. The first was Primodos. Between the 1950s and the 1970s, two little pills were given to women to test whether they were pregnant. From the late 1950s, concerns were raised that these tests could harm and cause abnormalities in a developing baby. Although disputed, there is a body of opinion that has linked these hormone pregnancy tests to a wide range of various malformations. We discovered opportunities where action should have been taken and was not.

These pregnancy tests were taken off the market in 1978 following concerns over their safety—more than a decade after safety concerns were first raised. No one listened. The risk to patient safety was not prioritised, one result of which has been a 40-year battle to get an independent review of the regulations that were found wanting. I accept that regulation was in its infancy in the 1960s and 1970s, but patient safety should have been the overriding consideration then, as it must be now.

In the course of our review, we met the children—now adults—who suffered so much and their families. Many dreadful impacts have been associated with these pregnancy tests, such as loss or shortening of limbs—we have seen other examples of this happening in the past—heart defects, spinal issues, seizures, dysmorphic facial features, digestive and bowel issues, and so on. We were struck by the unremitting guilt felt by the women who took the pills. They feel to blame for their children’s disabilities. They suffer enduring psychological harm, and although we told them, “It wasn’t your fault; you weren’t told; how can you be blamed?”, I fear that we did not convince them.

The second medication reviewed was sodium valproate. It is a very effective drug for controlling epilepsy but it has a history that should never be repeated. When first licensed in 1972, it was known to be teratogenic in animals. Prescribing doctors were warned that it should be used only in severe and resistant cases of epilepsy in pregnant women. In the 1980s, academic literature drew attention to the risks. In the 1990s, the risks of neural tube defects and other congenital malformations were known. Even then, women were saying that exposure to sodium valproate had caused damage to their offspring.

In early 2000, doctors were again warned of an association with delayed development in children, with delayed speech, IQ affected and reports of autism. Throughout this tragic history, clinicians have been warned and women and their families have not been listened to; they have been dismissed and had their knowledge denied. It took 40 years after sodium valproate was introduced to the market to produce a toolkit, the purpose of which was to provide information to women of childbearing age and healthcare professionals about the harm that could be caused. Two years later, in 2018, a pregnancy prevention programme was introduced; it stipulated three measures that were designed to prevent further harm.

You would suppose that this is the end of a tragic story—problem solved—but that is not so. It is truly shocking that, today, epileptic pregnant women on sodium valproate have a one in two chance of having a disabled child. They are still exposed to huge risks because they are not told what those risks are. Babies continue to be been born with lifelong disabilities due to exposure to this drug. We know that the results are catastrophic.

The third and final area that we were asked to review was surgical mesh, a device inserted to support pelvic organ prolapse and to treat stress urinary incontinence. For many women, mesh surgery is trouble-free and leads to improvements in their condition, but that is not the case for all. A BMJ article published on 10 October 2018 had the arresting headline “How mesh became a four letter word”. In the article, Jonathan Gornall charts the rapid rise and fall of vaginal mesh; it is, as he says,

“a story that offers lessons for the entire medical community, and for manufacturers and regulators”.

Unlike many other devices, polypropylene mesh is intended to remain in situ for life. We heard from countless women who sought to have it removed but were unsuccessful; sometimes attempts even caused further serious damage.

Why would they want it removed? Because mesh ruins their lives. We were told by hundreds of women that they suffer excruciating pain, recurrent infections and haemorrhages, bowel issues, recurring or new incontinence, and nerve damage that restricted their mobility. Fit young women were confined to a wheelchair for the rest of their lives. I will always remember one little boy telling us, “I just want my old mum back.”

We heard about sexual difficulties leading to the loss of a sex life and broken marriages. We heard from women how the constant pain resulted in the loss of employment—that is, their job—so they lost their income. Because of that, they could not afford the mortgage or rent so they lost their homes, and because they were homeless, they were fearful that their children would be taken into care. One woman told us:

“This is not a life. It is an existence.”


We were so shaken by what we heard that, in July 2018, we recommended that vaginal mesh should be paused. Our recommendation was immediately accepted by NHS England and the Department of Health and Social Care. The scandal is that our recommendations were not new; all had been suggested before, but no action had been taken. It should not have been for us to recommend this. If safety was of paramount importance, the healthcare system should have picked this up decades before. After all, mesh was first used in the 1960s. It gathered pace in the 1990s; by 2001, it was the most common operation used for ameliorating stress urinary incontinence—a very unpleasant condition, but not life-threatening.

Medicines and Medical Devices Bill

Baroness Cumberlege Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Baroness Cumberlege (Con)]

My Lords, I stand before you as a person who was shaken by the experience of personally listening to over 700 women and their families, who have been damaged by the healthcare system. Their testimonies actually haunt me. Their bravery impels me to right their wrongs.

In our report, First Do No Harm, we examined and researched two medications. First, Primodos, already very well explained by the noble Lord, Lord Alton, was a hormone pregnancy test taken between the 1950s and 1970s and associated with terrible damage to some newborn babies. Those newborn babies now need care and support as adults while their surviving mothers, now elderly, have lived a life wracked by guilt. Secondly, there is sodium valproate, an effective medication to control epilepsy. When taken in pregnancy, there is a 50% chance of a severely damaged child being born. Even today, that medication is still being given to women who are unaware of the consequences. Then there is pelvic mesh: a plastic net which can migrate, disintegrate and wrap itself around vital organs, severing some and causing appalling suffering and pain.

The root cause was the failure of the healthcare system as a whole, and by some in the medical profession who ignored the concerns of women and their families. These women knew what was wrong but they were dismissed. They were told it was all in their heads—just a woman’s problem, not to be taken seriously. This made me furious. As Sir Cyril Chantler, the review’s vice-chairman, reminded us, for whom is the healthcare system run? We pay for it; it is ours. It is run for us, the people and patients. Your Lordships all know, as I do, that when we are ill or in pain most doctors will listen. But if they sense that a mistake has been made, they clam up, become defensive and act irrationally.

Now for the good news. The report has raised a clarion call for action and I thank all parliamentarians who have been so supportive—particularly your Lordships, but you are not alone. There are the 15 patient groups, the Royal College of Surgeons, the Royal College of Obstetricians and Gynaecologists, the Royal College of Physicians, the Royal College of General Practitioners and the British Society of Urogynaecology—all with their medical membership—along with the BMJ, in its stunning editorial last week. All these and so many more want to see our recommendations implemented and we can start right now, with the safety Bill.

I intend to put down an amendment to appoint a patient safety commissioner—a voice for, and listener to, patients. If a product raises concern, that commissioner must say “Stop—this is a worry. We need to investigate and research to ensure safety”. It is better to have a few false alarms than the tragedies we have witnessed, which have cost lives, caused suffering and family break-ups, and damaged children. These are personal costs beyond price, with millions of pounds to be paid from the public purse.

We parliamentarians are establishing a parliamentary group called “First Do No Harm”. Its purpose is to ensure that all our recommendations are implemented. The only cloud on the horizon is the Department of Health and Social Care, which simply does not get it. Asking everyone, as it does now, to work together better in the future simply will not work, any more than it has in the past. We need someone and something new: a patient safety commissioner. Yesterday, we heard that the First Minister of Scotland, Nicola Sturgeon, has announced that Scotland is to have a patient safety commissioner on our lines. But in England, rumours are absolutely rife of a ritual burial and answers to the PQs are evasive. I say to my noble friend the Minister: this is his opportunity to give an assurance that this report will be implemented with a taskforce and timetable, as set out in our Recommendation 9. Please can the families who have been hit so tragically hard have that assurance?

Independent Medicines and Medical Devices Safety Review

Baroness Cumberlege Excerpts

Thursday 9th July 2020 Lords Chamber

[Lord Bethell]

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.

[Baroness Cumberlege (Con) [V]]

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?

[Lord Bethell]

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.

Safety of Medicines and Medical Devices

Baroness Cumberlege Excerpts

Thursday 28th February 2019 Lords Chamber

[Baroness Cumberlege (Con)]

My Lords, my interests are in the Lords’ register. I thank my noble friend for securing this debate. There are few who are better informed on this subject or more knowledgeable and committed than he is, as we have heard today. As has been said, I chair the Independent Medicines and Medical Devices Safety Review. It is focused on how the healthcare system has responded to concerns about medicines and devices raised by patients.

When the review reports later this year, we will make recommendations to improve matters, but in terms of what has happened up to now, three medical interventions are in our scope. The first is Primodos. This drug was withdrawn from the market in 1978 but concerns had been raised years earlier. Babies were born damaged. Those that survived are disabled. The second is sodium valproate. The link between sodium valproate and birth defects has been known for many years, yet women and babies continue to be exposed to the risk. Experts suggest that around 20,000 people have been harmed. For the families involved, it is life-changing and extremely distressing. For those women who took Primodos and sodium valproate, there is an intense feeling of guilt. They took the medication and they blame themselves. However hard one tries to persuade them that it was not their fault, the guilt remains.

The third intervention is surgical mesh. Many thousands of women have had mesh inserted for incontinence or prolapse. The majority have not reported any problems, but a significant and growing minority have suffered terrible complications, including: excruciating chronic pain, which has been described as feeling like razors inside the body; damage to organs; autoimmune problems; the loss of mobility; the loss of a sex life; and depression and suicidal thoughts. The impact of mesh is not only on the woman herself but on her family. The physical and mental pain has led to the break-up of marriages and partnerships, and many cannot work. If they lose their job, they face losing their home. Children have become their mothers’ carers and some women even face the prospect of their children going into care.

So concerned were we by what we heard about mesh that as an interim measure we recommended a pause in its use until the stringent conditions that we set have been met. That pause has been in place since last summer. I have carried out a number of reviews into health-related matters, but I have to say that this is the most troubling and the most harrowing. The suffering of so many people and their families is heart-breaking. The pain, both physical and emotional, is almost impossible to imagine. My team and I made it our priority to do something that the system has failed to do for all these years: to listen and to learn from what we hear.

We have travelled the length and breadth of the UK. We have met many hundreds of people who have been directly affected, and their families. We have heard from many more by email or phone. I pay tribute to all those we have met. Their courage and dignity in the face of such suffering are truly remarkable. It has been a privilege to meet them. The campaign groups that support them do simply wonderful work. I have been deeply saddened, not just by the personal stories but by the constant reminder that this harm was avoidable. Their lives have been turned upside down, but they did not need to be.

We will continue to listen to those affected. We have also received a huge amount of written evidence, all of which is on our website. We are now in the midst of our oral hearings, taking evidence from regulators, medical colleges, manufacturers, the NHS and others. These evidence sessions are video recorded and available via the review’s website. We are looking not to blame but to ensure that we learn.

Our starting point has been some simple questions. Could and should things have been done differently? Could actions have been taken more quickly? What needs to happen now, and who needs to do it? We have more evidence to hear before we write our report, but there are some emerging themes: the lack of proper warnings about risks; the lack of informed consent; a system whose first inclination is to deny there is a problem or simply to ignore concerns; where concerns are eventually heard, the sluggishness of a proper response; the dismissiveness and arrogance of some—I stress only some—in the medical profession; the byzantine complexity of a regulatory system that few within it, let alone patients and the public, seem to fully understand; the fight for diagnosis and support when things have gone wrong; and the inadequate resources available, whether for follow-up surgery in the case of mesh, or medical, social and educational care in the case of sodium valproate and Primodos.

Most troubling to me is that these issues have come to our attention not because they have been raised by regulators, doctors or the NHS but because of people power. People affected have organised themselves into campaign groups and, with the help of Members of Parliament, push the issue up the agenda until finally someone takes notice. That tells me something is seriously wrong; the system is not working as it should. People who have been harmed should not have to fight to be heard or to access the care they need.

Of course, no medical procedure is without risk, and innovation is crucial in healthcare; we must not stifle it. But it is vital that an individual is able to make an informed decision, based on a clear and full explanation of the benefits and risks, about a medicine or procedure. It is vital that regulators act with independence and impartiality in approving a medicine or device, that safety comes before commercial interest, and that they listen carefully to patient-reported concerns and act swiftly on them. It is vital that surgeons carry out operations for which they are suitably trained, that they have the right level of experience, that they show compassion and that a comprehensive database exists. When things go wrong and avoidable harm is suffered, the test of a good healthcare system—indeed, of a good society—is our ability to listen, to say sorry, to learn and to provide the right care and redress.

Noble Lords would be forgiven for thinking that these points are a statement of the obvious. A year ago, before I started this review, I would have thought so too. Having heard and seen what happens to people when the system fails, I now know they are not. There is much to be done before we can be assured that the system listens to concerns and responds as we would wish. I am determined that my review plays its part in making that happen, but this is a challenge for all of us in this place and in the healthcare system. Noble Lords taking part in this debate and others in this House possess expertise and experience that will be invaluable in ensuring we have a system fit for the future. I hope my review can draw on that as we continue our work.

Maternal Safety Strategy

Baroness Cumberlege Excerpts

Tuesday 28th November 2017 Lords Chamber

[Lord O’Shaughnessy]

I thank the noble Lord for his support for today’s announcements. Obviously, independent investigations are just that. They will be operated by HSIB, which will be able to delve into the causes of the tragedy, however it might have happened, and provide an opinion on that. On the interaction with the coroner’s report, obviously we have focused mainly today on these new independent investigations and we are looking at extending coronial law to take in stillbirths that were previously not included. That is one of the issues that needs to be worked out in the coming months through interaction with the Ministry of Justice.

[Baroness Cumberlege (Con)]

My Lords, I start by declaring my interests. I am a fellow of the Royal College of Obstetricians and Gynaecologists, the Royal College of Midwives and the Royal College of Nursing, and president of the National Childbirth Trust. Those positions are unremunerated but I am remunerated by NHS England for implementing the report of the review of maternity services.

There is absolutely no doubt that the Secretary of State has concentrated the minds of all of those working in and for the NHS on safety. It is the golden thread that has run throughout his time in office, especially now when he is concentrating on maternity services. We have never seen safer services, but we are being urged to go further with some new initiatives that have been declared today.

I welcome the Statement, particularly the part on investigations. Those of us tasked with implementing the report Better Births—the review of maternity services for England—have been concerned by the way many investigations have been conducted, causing further misery and trauma to the families concerned. We have full confidence that the Healthcare Safety Investigation Branch will ensure independence, and above all, will involve the families. After all, the families were there; they knew what took place. They have a legitimate role in investigations, but often their views and experiences are ignored. Even worse, the learning that has been gathered has not been passed down to the teams within the trust, nor indeed has it spread to other organisations in the wider world. It is absolutely essential that that happens so that we see fewer stillbirths, early neonatal deaths and brain-injured children.

It was those anxieties that made us in the maternity review consider a new scheme, for which we coined the title “rapid resolution and redress”. I pay tribute to Professor Sir Cyril Chantler, who was my vice-chairman. He has worked tirelessly with colleagues across the world and in this country to frame the scheme, so we are delighted that Ministers see the merit of this proposal. However, I should like to question my noble friend about the timing. I understand that more policy work is to be done, but is it possible to bring forward the second part of the implementation of rapid resolution and redress so that the families in question do not have to wait until 2019?

I am interested in the coroner’s investigations. I understand the desire to ensure that no stone is left unturned, but I want to express my concerns at this moment because it is another inquisitorial initiative, when RRR is designed to avoid using the courts in order to spare parents from trials and tribulations. Therefore, I ask my noble friend to consider whether there could be a pause so as to wait for the evaluation of RRR; otherwise, we will have a range of initiatives which not only might cause confusion but will be in conflict with one another. I thank my noble friends for introducing continuity of care—something that is very close to my heart.

[Lord O’Shaughnessy]

I am delighted to be able to respond to my noble friend, who, probably more than anyone else, has really led the charge in this area. I pay tribute to her for her work on better births, as I do to Sir Cyril Chantler, her deputy. She is right that patient safety is the golden thread that runs through all the work that the Secretary of State has led, and she is right to highlight that we have safer services. The changes that we are making, together with bringing forward the “halve it” ambition, will save 4,000 babies’ lives, which is a great prize.

With regard to my noble friend’s questions, the endorsement of the HSIB is very welcome. Some months ago I organised a briefing for noble Lords with Keith Conradi, who runs it, and I shall be very happy to organise another one. It is a very interesting organisation with an interesting methodology that has proved incredibly effective in the airline industry, where Mr Conradi comes from.

On RRR, I appreciate my noble friend’s concerns about the timing and I will certainly look into whether it is possible to bring forward its implementation. As she knows, there are some issues around governance and how it will operate that mean that we need to tread carefully, but I shall certainly take that into consideration because we want to get the scheme up and running as soon as possible.

Nursing and Midwifery (Amendment) Order 2017

Baroness Cumberlege Excerpts

Tuesday 28th February 2017 Lords Chamber

[Baroness Cumberlege (Con)]

My Lords, I declare an interest as a vice-president of the Royal College of Midwives.

I read the Second Reading debate that the noble Lord, Lord Hunt, introduced on the regulation of health and social care earlier this month. I was disappointed not to be able to listen to it in the Chamber because it had some eminent speakers. I read Hansard and, as so often, I was impressed by the clarity and first-hand knowledge that noble Lords brought to that debate. This time, the noble Lord, Lord Hunt, concentrated on beaming down on one aspect of regulation concerning one profession—midwifery.

In Parliament a couple of weeks ago, the general secretary of the Royal College of Midwives enlightened parliamentarians on the state of maternity services in 2016. Professor Cathy Warwick told us that, in the last six years, we have seen the number of midwives increase by 1,560, but that the increase has massively slowed down in recent years. As noble Lords have said in this debate, the work has been changing. First, we have seen an increase in the number of mothers giving birth. Secondly, we know that teenage pregnancies have declined—something we have sought to achieve in this country. However, older mothers over the age of 40 are giving birth and they have increased in number. Many of these women have long-standing health complications. They are sicker and sometimes they have babies who are more vulnerable and need greater care.

As the noble Lord, Lord Hunt, has said, the midwifery workforce is also changing, with an increase in the number of experienced midwives nearing retirement—one in three is now in her 50s or 60s. It is not so much about the numbers; this is a body of midwives who are really experienced. We need experienced midwives to ensure that new students coming in can understand the service in which they are working and the different skills they need. So we have to try to maintain the midwives that we already have and this order has a part to play. It is a new order and my noble friend the Minister gave a clear exposition of its value.

I want to probe some of its consequences a little. When we were carrying out the review of maternity services for England, the first thing we did was to ask the women, their partners and families what they wanted from maternity services. In this case, our constituency is the midwives. What do the midwives want? It was interesting that, when they were asked about statutory supervision going, they were very upset about it. Eighty-four per cent wanted to keep statutory supervision. They had keen concerns about patient safety and about the quality of assurance if supervision were removed from the law. They felt that the potential for the removal of support for midwives was considerable and they had concerns relating to the NMC’s ability to manage an increased fitness-to-practise referral rate.

These are genuine concerns and it is our duty to see that they are met as the roll-out of this new process takes place. I understand that the Secretary of State has commissioned another review of the NMC, again concerning Morecambe Bay. One case from there has still to be concluded after eight years. No wonder midwives are concerned about the NMC’s ability to manage an increased fitness-to-practise referral rate. The NMC has to step up to the plate. Look at how the GMC has evolved over years: the first thing its new chief executive did was ensure that it was an efficient organisation. I do not get that feeling of confidence with the NMC. Some work needs to be done on that, maybe on aspects brought up by the review.

In the five-year forward view, which was agreed between the DoH and NHS England, an ambition was laid out to make it easier for groups of midwives to set up their own NHS-funded midwifery services. We all agree that we need more midwives. Since the publication of Better Births, a small group of midwives called Neighbourhood Midwives has gathered together and managed to get a contract from the NHS. This gives us more midwives and women more choice, which is something we should applaud. However, it is important that midwives are subject to regulation, wherever they are working, and that has been the case since the European Union brought in its directive. There is a long-running saga about independent midwives and I declare my interest as a patron of Independent Midwives UK. The NMC has felt it right to ensure that independent midwives are suitably covered for clinical indemnity when delivering women giving birth, and it is right to do so. However, I cannot glean from the NMC what level of indemnity is required. I have asked five times what is the “appropriate”—the NMC’s word—cover that it requires for clinical indemnity for independent midwives. I get no answer. I do not know whether the NMC realises how difficult it is to get clinical indemnity to cover people working in different professions. Although a lot of the cases that are brought are actually systems failures, sometimes they are obstetric failures. It is right that the regulators should look at the safety record of those they are indemnifying and I am not sure that is understood by the NMC.

The first questions that any insurance company is going to ask are: “What is meant by appropriate? What size of pot is required?”. Again, we get no answers. The NMC has spent a very long time warning independent midwives that they could lose their registration. Four days before Christmas, the NMC sent a letter out telling independent midwives that they had lost their right to practise. Four days before Christmas, these trained midwives, who had spent a long time in the service, were in fear of losing their livelihoods, vocation and profession. Above all, they lost their right to attend in labour women whom they knew well. As the noble Baroness, Lady Walmsley, has said, that is so important. We know that if there is continuity in the person looking after the woman through antenatal, the birth and postnatal care, we reduce the number of premature births by 24%. Premature births are expensive, emotionally and in monetary terms. If we can reduce them by that percentage we should strive very hard to achieve it.

Since these independent midwives have sought clarity from the NMC, the NMC owes it to them, but they have received conflicting advice. In its values, the NMC states that it wants to be “fair”. My noble friend raised the question of fairness. The NMC says that it will be,

“consistent in the way we deal with people”.

I cannot see that consistency. All the midwives and women who have rung me up and sent me emails have said that they do not understand the consistency because it is not there. It seems to apply one way to one midwife and another way to another, depending on the relationships—sometimes family ones—with the women. I welcome the review of the NMC, not least to examine the level and content of communication provided to those registrants who are seeking clarity, so that they know where they stand. That is the least that a registration body should do.

Better Births, the report of the maternity review for England, has two central themes: choice and safety. As my noble friend said in his introduction to this debate, safety should be at the heart of the service. We agree with that and safety is attached to the order. In our travels during the review, we listened to countless women—lots of them—trying to find out exactly what they wanted from the service. One strong response was that women and their families are seeking a safer service. I will tell noble Lords, and particularly the Minister, about our visit to Sweden because we are waiting for a consultation paper and I hope my noble friend will put pressure on the Secretary of State and his colleagues to release it. Over the last five or so years, Sweden has reduced the number of serious birth injuries from 20 per 100,000 babies born to five. In England, our current rate is 30 per 100,000. Last year, the NHS Litigation Authority paid out £560 million to 130 families for children who had been damaged at birth, while another 70 families who were not able to establish clinical negligence in this country received no compensation at all.

NHS: Community Pharmacies

Baroness Cumberlege Excerpts

Tuesday 6th December 2016 Lords Chamber

Asked by

[Baroness Cumberlege]

To ask Her Majesty’s Government how they plan to enhance the role of community pharmacies in providing NHS services to patients and the public.

[Baroness Cumberlege (Con)]

My Lords, I beg leave to ask the Question standing in my name on the Order Paper. In so doing, I draw attention to my interests as declared in the register. Also, I am a vice-chairman of the All-Party Parliamentary Group on Pharmacy.

[The Parliamentary Under-Secretary of State, Department of Health (Lord Prior of Brampton) (Con)]

The Government recognise the vital importance of community pharmacy. Our recent reforms will reward quality and embed and integrate pharmacies with primary care, improving the services offered to the public and making better use of pharmacists’ clinical skills.

[Baroness Cumberlege]

My Lords, I thank my noble friend for that Answer. We are at one in agreeing that community pharmacy has an important part to play in the nation’s health. Is my noble friend aware of the report carried out by PwC, which showed that community pharmacy contributes £3 billion net to the NHS, the public sector, patients and wider society? That is through just 12 additional services; it excludes the core work of dispensing medicines. Will my noble friend and his ministerial colleagues reconsider the swingeing 7.4% cut in the income of community pharmacies next year and instead invest in their services, which are accessible 24/7, enhance the public’s health, and prevent patients going to more expensive GPs and ultimately to hospital and A&E departments?

[Lord Prior of Brampton]

My Lords, I do not recognise the figure of 7.4%. The actual reduction is 4% next year and 3.4% the following year. I echo my noble friend’s comments and recognise the huge importance of community pharmacy. If we look forward 10 years, we will see a much greater role for community pharmacy within the NHS in supplying many of the services that are currently supplied by more conventional NHS services.

Junior Doctors: Industrial Action

Baroness Cumberlege Excerpts

Monday 25th April 2016 Lords Chamber

[Lord Prior of Brampton]

My Lords, there is an important distinction to be made around withdrawal of emergency cover. I can of course sympathise with the tens of thousands of patients who have been badly inconvenienced—that is bad enough—but when you withdraw emergency cover, people can die. It will be surprising if there are not some severe outcomes from what is happening tomorrow. Tens of thousands of people have been severely inconvenienced; tens of thousands of people have had their treatment disrupted, but the real tragedy will be when people lose their lives.

[Baroness Cumberlege (Con)]

My Lords, I thank the Minister for setting out some of the difficulties that junior doctors face. I declare an interest: I run a company which trains a lot of junior doctors. Ten years ago I did the work on professionalism for Dame Carol Black and we produced our report, Doctors in Society. We said that professionalism is signified by the values, behaviours and relationships that underpin the trust the public have in doctors.

On Wednesday of last week I made a statement—I was asked to give a lecture—and I threw down a gauntlet to the Royal College of Physicians and said that it was 10 years since we did that work; would it not now consider redoing it? I am delighted to say that it has accepted that and I hope my noble friend will support it.

Medicine is a much-respected profession and withdrawing care from those in extremis is an erosion of professionalism. It is also an erosion of trust that the public have in doctors. I hope this strike will be resolved as soon as possible and that, at least, we can get on to see the issues that the Minister has mentioned and address them through the royal college and the academy.

[Lord Prior of Brampton (Con)]

My Lords, time is up so I shall be very brief. I am delighted that the Royal College of Physicians is going to redo its work on professionalism. My noble friend is right that the real damage could be a long-lasting damage to the public’s trust in the profession. However, I am sure it will be rebuilt in time.