NHS England: Ovarian Cancer

Baroness Burt of Solihull Excerpts

Thursday 2nd May 2024 Lords Chamber

[Baroness Burt of Solihull (LD)]

My Lords, I totally agree that the wording looks a bit odd, to say the least, and that we should give special consideration to the wording for people for whom English is not their first language. However, there are tens of thousands of trans and non-binary people who would be missed out if we did not spell out that trans men can still get ovarian cancer and trans women can get prostate cancer. Does the Minister agree that what we need is clear, incisive language, so that everyone can be aware of the health risks that apply to them?

[Lord Markham (Con)]

Yes, absolutely. We all come at this from the perspective of making sure that health is front and centre, which is why the primary descriptors should be “man” and “woman”, as I think we all agree. Beyond that, we should clarify that “woman” may mean a “person with ovaries”—but the primary descriptor is “woman”. I hope that we can all agree on that.

Cass Review

Baroness Burt of Solihull Excerpts

Wednesday 17th April 2024 Lords Chamber

[Baroness Merron (Lab)]

My Lords, Dr Cass and her team are to be thanked for their rigour and their care with this report, in which they have navigated many complex and sensitive issues. This review into the NHS’s gender identity services concludes that children and young people have been let down by inadequate research and evidence on medical interventions, and they have been failed by inadequate services amidst a debate which has, sadly, been marked by extreme toxicity.

At the same time, at the heart of the complexity around gender identity services are two aspects that are simultaneously true. There are trans adults who have followed a medical pathway and say that, for all the pain and difficulty involved, it was not just life-affirming; it was life-saving. There are also people who followed a medical pathway and say that it has ruined their lives irreversibly and ask how anyone could let that happen. For those children, young people, and now adults, but particularly those who are being referred into gender identity services today, there is a duty to get this right.

The Cass review refers to many scandals, which exposes both the inordinate amount of time that children and young people are waiting for care while their wellbeing deteriorates, and medical interventions that have been made on what could be called shaky evidence. Can the Minister say how it came to be that NHS providers refused to co-operate with this review? How was it allowed that adult gender services would not share data on the long-term experience of patients? What accountability does the Minister feel that there should now be?

The Minister will know that the discussion around the substance of the review has been highly toxic. People have felt silenced, and it has required investigative journalism to prompt this review to take place. Tribute should be paid to journalists, including Hannah Barnes, and to the whistleblowers, who together helped shine a light on the Tavistock clinic. It is concerning to note that Dr Cass said that the

“toxic, ideological and polarised public debate has made the work of the review significantly harder”,

and that will

“hamper the research that is essential to finding”

a way forward. This particularly vulnerable group of children and young people is at the wrong end of the statistics when it comes to mental ill health, suicide and self-harm. They have been badly let down, so we owe it to them to approach this discussion with the sensitivity it demands.

Parts of this report today will sound very familiar: services unable to cope with demand; significant staff shortages; a lack of workforce planning; and unacceptably long waits for the mental health support and assessments that children and young people need, such that in some cases children become adults before they even get a first appointment with the gender identity services. To this point, the Cass review recommends a follow-through of services up to the age of 25, to ensure continuity of care. Will the Minister indicate how long it will take to establish these services, and could the Minister set out what plans there are to cut waiting times for assessments for mental health and neuro- developmental conditions?

Last month’s decision by NHS England to stop the routine prescription of puberty blockers to under-18s is welcome. However, the loophole that exists for private providers risks illegal trading. In the other place, the Secretary of State said that she expected private clinics to follow the report’s recommendations to follow the evidence. I underline our support for these expectations on compliance. Does the Minister consider that further regulation might be needed to enforce the recommendations? Could he say something more about the timescales involved in making progress, both for the CQC to incorporate the recommendations into its safe care and treatment standards and for NHS England’s urgent review on clinical policy for cross-sex hormones?

Children’s healthcare should always be led by the evidence and be in the best interests of their welfare. Dr Cass’s report has provided the basis on which to go forward. This report must also provide a watershed moment for the way in which society and politics discuss this issue. There are children, young people and adults, including trans children, young people and adults, who are desperately worried and frightened by the toxicity of the debate. There are healthcare professionals who are scared to do their job and make their views known. I hope that we can now put children’s health and well-being above all else.

[Baroness Burt of Solihull (LD)]

My Lords, I believe that the Cass review is an extremely thorough summary of where we are now and of the pathways available to young people that we need to explore. Most importantly, this report gives a way forward for young people and their clinicians who feel anxious and frightened because they find themselves at the centre of a political maelstrom.

Interestingly, the most balanced response I have seen to the report came from Stonewall, which was consulted by Cass, and I have used some of its points here. Cass says that these youngsters have been sorely neglected by the NHS, which sidelined them away from mainstream care to services that have fallen short. She points to how we can start the process of making it up to them, by giving them the holistic care that they need and deserve.

Despite the way in which the report was received by certain gender-critical individuals, it does not question trans identities or recommend rolling back healthcare access. It does not say that puberty blockers are unsafe or dangerous. It does say that there is insufficient and inconsistent evidence about some of the effects of puberty suppression. In addition, it notes that cross-sex hormones are well established and have transformed the lives of trans people, and supports their use from the age of 16. Importantly, it does not, at any stage, suggest a ban on social transition for any age of child or young person, but recommends that this be done with the support of parents and clinicians.

Cass says that gender incongruence is a result of a complex play between many biological, psychological and social factors, of which sexual orientation can be one. There are many factors, and no simple answer. For example, saying that such young people are simply confused gay people, unhappy teenagers, or that it is all the fault of social media, is all too simplistic. Regrettably, this has not stopped the Government spinning their own version of who is to blame.

For example, this week’s Statement by Secretary of State Victoria Atkins said that Tavistock clinicians “almost always” put children on an irreversible path of blocking puberty, then prescribed cross-sex hormones and on to surgery as an adult. This is not my understanding of the situation. In 2019-20, only 161 under-19s were referred by gender identity development services for puberty blockers. It was estimated that only around one in six GIDS patients ended up being prescribed puberty blockers. Is not the picture bad enough, without painting something even worse?

There are currently more than 5,000 children on the waiting list for treatment. The NHS has confirmed that everyone currently on puberty blockers via the NHS—fewer than 100 children—will be able to continue on them. These children, and any new recommendations for puberty blockers, will not be prescribed unless they agree to take part in a clinical trial to test the effectiveness of puberty blockers properly. How long does the Minister estimate that it will take for this clinical trial to be set up? Speaking of waiting lists, I understand that it currently takes three years for a child on the list even to be seen. How will the trial ever be set up, except for the few now on puberty blockers, while the rest languish for years on waiting years while their puberty seeps away? Does the Minister not agree that it is time to make up this shocking treatment which has, or rather has not, been given to children by the NHS and put them immediately on a par in priority with other NHS services?

These are our children. They, and the clinicians who want to treat them, have been intimidated by the toxic environment that we have all helped to create. I have heard the Cass report described as a rock that we can now all cling to. We will never all agree about some quite fundamental issues regarding trans and the nature of trans, but we must never make our children suffer for it; we must never make them pawns in a zero-sum game. We must rise above it and argue well, with more light than heat, to protect our children, who, after all, must be at the centre of all we seek to do.

Midwives: Bullying

Baroness Burt of Solihull Excerpts

Tuesday 16th April 2024 Lords Chamber

[Baroness Burt of Solihull (LD)]

My Lords, among the very disturbing elements in this report is the way that midwives are bearing the brunt of the toxic culture and dangerously low staffing levels, which are causing over half of midwives to consider leaving their organisation. Despite what the Minister just said, the Ockenden report was over two years ago. Is he satisfied with this rate of progress? Should we not consider a statutory inquiry—a recommendation of this report—before more midwives leave and more babies die?

[Lord Markham (Con)]

We have the highest level of staffing ever in midwifery, 5% up on last year and 21% up on 2010, against a background of static births. I want to address that point on staffing; staffing levels are high. However, as the noble Baroness says, there are issues around culture. On the national inquiry, again, every one of those 150 trusts was visited by the CQC in the last year or so and action plans made on how to address this. We know what we need to do; we just need to get on and implement it.

Sodium Valproate and Pelvic Mesh

Baroness Burt of Solihull Excerpts

Monday 25th March 2024 Lords Chamber

[Lord Markham (Con)]

I thank the noble Baroness. I was actually speaking to Minister Caulfield about this just this morning, because she is in regular touch with the affected patient groups. They were talking precisely about some of the things around the Scotland NHS scheme in place in terms of redress. It is fair to say that there are some concerns in patient groups on some aspects of this, but underlying what the noble Baroness says is making sure that, whatever we do, we are trying to do it consistently across the UK because there should be one consistent approach. Likewise, we are learning lessons from these things as well.

[Baroness Burt of Solihull (LD)]

My Lords, an ex-constituent of mine, after years of excruciating pain, the onset of returning cancer and no care plan, finally borrowed $47,000 to have the failed mesh implant removed in America. She now has her life back but is in deep debt. However, we learn that the Government will consider redress only in 2025. Can the Minister hazard a guess as to how many more mesh-induced deaths will have occurred by the time a single penny is paid out in compensation at this rate?

King’s Speech

Baroness Burt of Solihull Excerpts

Thursday 9th November 2023 Lords Chamber

[Baroness Burt of Solihull (LD)]

My Lords, in the time available to me, I would have liked to address my remarks to the effect that the new legislation will have on two of my main areas of interest: equalities and prisoner welfare. However, that would have made a very short speech indeed. The word “equality” does not feature once in the gracious Speech and one government equalities pledge, made more than five years ago, has still not found its way into proposed legislation. I refer, of course, to a conversion therapy banning Bill.

I should not have been surprised. After coming first as the most LGBTI-friendly country in the Rainbow Europe rankings between 2011 and 2015—this coincides with the time when the Liberal Democrats were in the coalition Government—we have since slumped to 17th place today. But do not worry: I have a cunning plan to help the Government out. Reading the runes, I feared that this Bill might drop off the parliamentary agenda, so I entered the ballot for Private Members’ Bills to bring in my own Bill—and guess what? My conversion therapy prohibition Bill came first in the ballot. This is definitely meant to be; we will be able to debate this issue in Parliament, as we should.

It is a shame that a mental health Bill has also been omitted from the Government’s agenda. I do not need to take up the House’s time to spell out how much of an effect poor provision and lack of resources are having on those suffering from mental illness as my noble friend Lord Allan has already more than done that issue justice today. Compared with crowd-pleasers such as pedicab regulations and a football regulator, which I am sure are important to many—well, football is at least—the Government have chosen to put mental health in the “too difficult to tackle” box before they lose the next general election.

However, we have the criminal justice Bill, some aspects of which are very welcome, such as taking steps to equip our police and criminal justice systems to better tackle violence against women and girls, criminalising the sharing of intimate images and introducing a statutory aggravating factor at sentencing for offenders who murder partners at the end of a relationship. However, long sentences and mandatory terms of imprisonment may well be contrary to some of the Government’s other worthy aspirations for prisons. You cannot grow your way out of an increasingly overcrowded penal system by locking up more and more people for longer and longer periods. In this country we lock up more people per head of population than many other countries, even those more right wing than this one. In fact, we lock up 50% more per head of population than the EU average. While mandatory sentencing and increased length of sentences might look good to right-wing voters on an election leaflet, they will be counterproductive in the longer run—not that this Government need necessarily worry about the longer run.

Every pound we spend housing prisoners is a pound less to spend on rehabilitation and support to help ensure that, on release, prisoners can take their place in society as citizens and do not end up back in prison, costing the taxpayer even more money and causing victims of crime even more suffering in future.

Finally, I want to tackle race hate, which is of course an equality issue. This feels particularly timely given the impact the horrific Israel-Gaza conflict has had in the UK. The Home Secretary has only added fuel to the fire with her divisive rhetoric and declarations of “hate marches”, which have incensed our Muslim communities and many others, while British Jews continue to feel unsafe, as well they might. Since 7 October anti-Semitic incidents have increased by more than 600%, while Tell MAMA, an organisation that measures Islamic hate crimes, has recorded a similar sixfold increase. This month is Islamophobia Awareness Month, and perhaps the Government should realise that backing one side against another here in the UK is harmful, not least further damaging their prospects in the next general election with the votes they will lose from the Muslim community. All our communities deserve our protection and support, not only in times of conflict. At this time, when we remember all those who suffered and continue to suffer in war, please let us learn the lessons of the past. Never forget what war can do to humanity.

General Medical Council: Internal Guidance

Baroness Burt of Solihull Excerpts

Tuesday 17th October 2023 Lords Chamber

[Lord Markham (Con)]

Yes, I am very happy to do that and to make clear the feelings of this House.

[Baroness Burt of Solihull (LD)]

My Lords, I welcome the Minister’s comments on the GMC and endorse its independent role. I commend its wish to treat all patients with dignity and respect. Even though there are only a relatively tiny number of trans men giving birth each year, they all matter and they all deserve to be treated with respect and dignity. If he can, will the Minister tell the House how both women born as women and trans men are to be treated with equal respect, without offending either group?

Gender Identity Services: Children and Young People

Baroness Burt of Solihull Excerpts

Wednesday 19th April 2023 Lords Chamber

[Lord Markham (Con)]

My noble friend will be aware that I do have some personal knowledge in this area, and I recognise very much the point that neurodiverse people can become fixed on a certain outcome. In terms of the statistics, yes, as many of a third of the people seen at Tavistock do have those sorts of conditions. So, it is something that is understood. Again, I am happy to pick up afterwards. The key point of the Cass review in all this is that these people need to be seen by medical doctors who are considering everything in the round and not just coming at this through a gender identification lens. That is the key thing we need to make sure happens going forward.

[Baroness Burt of Solihull (LD)]

My Lords, whatever one’s views on trans issues, surely the first imperative is to ensure that young people are properly looked after. Would the Minister agree with me that every young person suffering from gender dysmorphia, whether they have attended the Tavistock or not, should receive professional counselling and support? If he does agree, can he ensure that the resources are available in a timely manner, so that these young people do not have to wait years while they try to unravel the complex set of issues they face concerning their gender identity?

[Lord Markham (Con)]

Again, my understanding—and I freely admit that the benefit of having these questions is that you then delve into them, which I very much support in terms of how this process works very well —is that these people who have been through these services need to be looked after and catered for, so that is something we are very much on.

Mental Health: Advertising and Body Image

Baroness Burt of Solihull Excerpts

Thursday 30th June 2022 Lords Chamber

[Lord Kamall (Con)]

I hope the noble Baroness will recognise that before the pandemic, we were meeting the waiting times targets for many younger people. Clearly, as with many things in our health and social care service, the pandemic has had a huge impact—not only delaying the treatment of people who should have been treated before the pandemic, but increasing the number seeking help with mental health issues. As I am sure noble Lords will recognise, for young people those two years were a massive proportion of their lives compared to us. Those are lost years for them, and it has led to many mental health issues. As the noble Baroness will know, we have announced the draft mental health Bill. The NHS long-term plan will have an additional £2.3 billion a year for mental health services by 2023-24, and an extra 2 million people will be able to access support. This will all take time, and we will have to work through that.

[Baroness Burt of Solihull (LD)]

Noble Lords have rightly been criticising advertising that promotes unrealistic body images, but the Government themselves are not helping. In April last year, the Women and Equalities Committee published a report on body image. According to it, the Government’s own obesity strategy actually

“contributes to eating disorders, and … mental”

ill-health. The Minister is nodding, so in the interests of brevity I ask him: does he agree with the recommendations of this committee, and what are the Government doing to remedy their approach?

Medicines and Medical Devices Bill

Baroness Burt of Solihull Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Lord Lansley (Con)]

My Lords, I am very glad to have the opportunity to follow my noble friend Lord Ribeiro and to speak to my Amendment 104. I am grateful to the noble Baroness, Lady Finlay of Llandaff, for bringing forward her amendments as well. They highlight some useful points and—particularly Amendment 101—focus on the necessity for patients to be provided with information and for patient experience to have its place in the information systems to be created under Clause 16. My noble friend Lord Ribeiro very helpfully illustrated that the benefit of the joint registry and similar information systems is not simply to promote safety but also to improve outcomes. We can certainly look forward to seeing both happening in the future.

My Amendment 104, to which the noble Baroness, Lady Finlay, and the noble and learned Lord, Lord Woolf have added their names, requires that the regulations made under Clause 16 include specific reference to the Caldicott principles. Noble Lords will recall the establishment of those principles back in 1997. They say that an organisation should:

“Justify the purpose for using confidential information”


and that the NHS should not

“use confidential data unless absolutely necessary”.

The NHS should:

“Use the minimum necessary personal confidential data”,


while

“Access to personal confidential data should be on a strict need-to-know basis … Everyone with access to personal confidential data should be aware of their responsibilities”


and, when using data, NHS personnel should “comply with the law”. In 2003, a seventh principle was added:

“The duty to share information can be as important as the duty to protect patient confidentiality.”


In a sense, a balancing principle was added as number seven. The amendment refers to those two reports, which have given rise to those principles. I am interested generally in the proposition of how certain we are that the Caldicott principles are being applied in every case. I think in these regulations it would be to the benefit if they were restated, given the importance of this as an information system.

I will ask three questions of my noble friend. First, can he assure us that the regulations themselves will make specific reference to the Caldicott principles? This would mean that we did not need to put it in the Bill. Secondly, in establishing these information systems, can we be assured that Caldicott Guardians will be appointed specifically in relation to each of the information systems that are to be established? Thirdly, can my noble friend tell us any more about the National Data Guardian’s consultation, which opened in June and closed in September, on an eighth principle:

“Inform the expectations of patients and service users about how their confidential information is to be used”?


This ties very directly into Amendment 101 in the name of the noble Baroness, Lady Finlay of Llandaff.

If it is endorsed by the National Data Guardian, that principle would give rise to an additional principle being reflected in the regulations. I freely confess that this is a good reason not to put my amendment in the Bill, because the nature of the Caldicott principles might well change in the immediate future, so it is not very helpful to entrench it in its current form. If we get the assurance that we are looking for from my noble friend, I hope the regulations, when they are made, will be able fully to reflect the Caldicott principles.

[Baroness Burt of Solihull (LD) [V]]

This string of amendments all talk about recording information, and I broadly agree with all of them. I particularly mention Amendment 104, in the name of the noble Lord, Lord Lansley, because of the mention of the Caldicott principles. Many people, particularly noble Lords in the Liberal Democrat party, jealously guard our right to privacy—hence the promissory tone of Amendment 100 in the name of my noble friend Lady Jolly.

The purpose of the proposed new clause in Amendment 107, to which I have put my name, is slightly different from that of the other clauses because it seeks to ensure that a proper systematic analysis is made of the effectiveness of mesh implants through registers. The Cumberlege review notes that registries are

“few and far between and all too often prompted by catastrophe”

in relation to transvaginal mesh and PIPs. This is obviously a good phrase because the noble Baroness, Lady Finlay, has already picked it out of the report.

This clause proposes a register. It requires the Secretary of State to report on progress towards creating databases relating to other devices. I appreciate that there are many databases out there—far more than I anticipated when first became involved in this Bill. The idea of the registries is to draw all this information together. As the Cumberlege report says,

“a ‘registry’ … would act as a repository for more complex patient related information datasets enabling research and investigation into patient outcomes.”

This would be more holistic and far more useful than just a database, enabling any adverse outcomes to be spotted early and not allowed to fester, literally, for years before defaults are spotted.

Patient groups must be consulted on devising the register. Time and time again, victims reported that they had not been listened to, despite the fact that the mesh felt “like razor blades” inside them. Never again must a patient feel patronised, unheard or left to suffer in silence. Of course, those healthcare professionals at the coal face, as it were, of the issues must have their say. We know that some registries exist today, but this database would bring everything together, instead of the piecemeal system we have at the moment.

I will go back to the lady whose poignant testimony I quoted at Second Reading, whom I called Jane. Jane had an estimated five pieces of mesh inside her, although the health professionals treating her maintained that there were only two. How can this be? I leave noble Lords to speculate but, in my view, this is a sharp indictment of the state of the service our health service gives to patients in this area. Unless we have a proper register of everything that is inside a patient, when it was inserted and what its performance record is, how are we going to enable them to be given the appropriate treatment when problems arise? The Royal College of Surgeons endorses this view—it wants all medical device implants overseen by registries.

Finally, I express my gratitude to the noble Lord, Lord Bethell, for the briefing this morning. I was very heartened to learn of the hard work going on in this area and the aspiration that a register for vaginal mesh implants could be up and running in only a year. I wish the Bill well.

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, first, I apologise for not being able to participate at earlier stages of the Bill because of the clash with speaking in the Chamber. I congratulate the noble Baroness, Lady Finlay, on introducing these amendments and, especially, my noble friend Lady Cumberlege for all her work in preparing her report in advance of this. I also thank the Minister, my noble friend Lord Bethell, for briefing us this morning. I will particularly speak in favour of Amendments 100 and 101.

I hope that my noble friend the Minister will look favourably on patients being able to report directly to the register. The testimony that my noble friend Lady Cumberlege and others heard in the context of her report was very moving. As my noble friend Lord Ribeiro said, it is absolutely essential that the voice of patients is heard. This absolutely goes to the heart of medical and surgical treatment. We must ensure that, whether they have had a good or a bad experience, patients are able to place their experiences on the record. Amendments 100 and 101 go some way to achieving that. Were my noble friend not to like those amendments, I hope that the Government would come forward with a similar provision to put our minds at rest. I thank the noble Baroness, Lady Finlay, for these amendments, and I lend my support to them.

Medicines and Medical Devices Bill

Baroness Burt of Solihull Excerpts

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

[Baroness Burt of Solihull (LD) [V]]

My Lords, I speak to Amendments 10, 12 and 74, to which I have added my name. Although I support all the amendments in this group, they pretty much do the same or a similar kind of job, but I added my name to those amendments specifically because they speak to safety being paramount for new drugs and devices. I say that because the excellent Cumberlege report tells the graphic and heart-rending story of what happens when it is not.

We have heard about the effects of the drugs Primodos and sodium valproate from the noble Baroness, and other noble Lords will cover those areas. My interest relates to mesh and what happens when insufficient care is taken in the implementation and tracking of the well-being of women who have had it inserted. When it goes wrong, it really can ruin the life of the woman affected. Noble Lords may recall the case that I mentioned on Second Reading of how Jane’s life has been ruined by mesh—not just physically but emotionally and economically. The noble Baroness described such things as well. Yet the surgeons who did this to her seem to exhibit no remorse and have closed ranks, denying the very existence of some of the pieces of mesh inside her.

It makes my blood boil to hear those harrowing stories, and the noble Baroness had to listen to such testimony from victims for two years. As she says in her report, this took its toll on her and the other members of the panel, but how much worse must it have been for the victims themselves? Yet we see phrases in the Bill such as,

“the appropriate authority must have due regard to ... the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines”.

Attractiveness? What does that even mean? My noble friend Lady Jolly spoke on the third group of amendments about the multiple interpretations that the term could have. Are we trialling drugs and devices on human beings so that we can subsequently flog them abroad? I am sure that the Minister will deny that and give us a proper definition of the word.

Attractiveness and availability must be a low priority compared with safety and that is why I strongly commend the amendments. If the Minister believes that safety must be the overriding consideration, I trust that he will have no difficulty in accepting them.

[Lord Patel (CB) [V]]

My Lords, as I was not able to get in following the comments made by the noble Earl, Lord Howe, I say that, as a Cross-Bencher, I was irritated that we were not involved in the communication, I am glad that the statement has been made and I concur with most of the comments of the noble Baroness, Lady Thornton. I hope that from now on the procedure will be better. I had threatened to negative the amendments, but I will not do so now.

I speak in strong support of Amendments 10, 12, 74 and 75 tabled by the noble Baroness, Lady Cumberlege, to which I have added my name. I concur with all that she and other speakers have said. So far as her findings were concerned, I will repeat what I said when we debated her report. The profession needs to hide its head in shame that such trauma was inflicted on women and that such harm to unborn children was caused by disregard for guidance. As an obstetrician, I have never used mesh; I am one of those old-fashioned surgeons who did not use any artificial devices, but then I was not regarded as an avant-garde or fancy surgeon in that respect. Her report is a salutary lesson about the importance of patient safety. I will confine my remarks to medicines and medical devices, and the importance of embedding patient safety.

The noble Baroness’s report is entitled First Do No Harm. I say with humility that the motto on my coat of arms is “Primum non nocere”. I am privileged that the shield that bears it will hang for ever in the chapel of St Giles’ Cathedral in Edinburgh. I took that motto not because of the medical oath, which of course is correct, but because I was at the time chairman of the National Patient Safety Agency of England, an organisation that the noble Lord, Lord Hunt of Kings Heath, had chaired before me. It no longer exists, but its aim was to establish the whole concept and methodology of patient safety in the NHS in England. The NPSA, as it was then known, had developed a confidential reporting system for incidents relating to patient safety for healthcare staff and patients. Nearly 40% of the large number of reports—we used to get as many as 200 confidential reports a day—were related to medicines, medicines delivery and devices.

The concept of the safety of medicines is not new, and the experience of over a century has framed laws, regulations and amendments to make medicines safe and effective. In 1937, more than 100 deaths were reported in relation to sulfanilamide. They were due not to the medicine itself but to the solvent, diethylene glycol, which was added to the active ingredient. This led to regulations requiring testing of medicines in non-clinical and clinical settings prior to their being licensed for therapeutic purposes. Is it not ironic, especially in the context of the report of the noble Baroness, Lady Cumberlege, on Primodos, that the drug thalidomide, used as an antiemetic in early pregnancy, was not licensed in the USA due to animal studies that had shown some deformities in animal embryos? The USA therefore avoided the harm that the medicine caused to unborn children and a condition called phocomelia. It was accepted in a large part of the world, including the United Kingdom, and resulted in tens of thousands of children being born with such deformity.

There are patient groups to whom regulators need to pay special attention when approving medications, such as pregnant women, children and older people. We will come to amendments later on alluding to this. There are many examples of medications that are withdrawn from the market because of patient harm, emphasising the importance of a secure system of post-licensing surveillance. Some 1.1 billion prescriptions are supplied every year in primary care. Furthermore, a mid-sized hospital supplies about 50,000 doses a day. A study in 2018 showed that 237 million medication errors occurred every year in England, of which 68 million caused some degree of harm. While the harm may appear in one part of the system, the solution often lies across it. Much can be learned from a well-run and monitored national reporting and learning system, particularly as to which medicines are commonly involved in errors and hence patient harm. A single change that would make a big difference is a system that recognises and establishes the greater involvement of patients in their own care.

A healthcare system that wants to achieve a significant reduction in patient harm from medications will need a national programme in which different parts of the system work together. The amendment in the name of the noble Baroness, Lady Cumberlege, may be a start to that, and I commend her for it.

Unlike with medicines and the EMA, even at EU level, there is no agency for the safety of medical devices. Regulation relating to medical devices or standards is often a voluntary process and is not governed by national or international standards unless recognised by a regulator as mandatory. The list of what constitutes a medical device is long and ranges from machines and in vitro reagents to software. As the UK leaves the EU, it has an opportunity to devise a system of regulation focused on safety. In 2017, there were more than 16,000 device-related reports of harm. Following the publication by investigative journalists of a series of reports on medical devices known as “The Implant Files”, there has been a demand from doctors and others for greater transparency from manufacturers of devices, particularly regarding safety. The same stringent regulatory process, including disclosure of data related to adverse events, should be part of a market approval process.

I know that several amendments coming up are related to safety and licensing, which currently does not exist in the UK for medical devices. The amendment in the name of the noble Baroness, Lady Cumberlege, in relation to patient safety, including medical devices, will go further than current requirements for market approval. Information and data related to safety, both short-term and long-term, may well be a requirement for market approval. Why is it necessary to have full safety data to license a cardiac drug but not for an implanted pacemaker? As an example, a device called Nanostim was withdrawn from the market three years after safety approval due to the alarming number of patients to whom it was causing harm, by which time 1,400 patients had had it implanted. The noble Baroness is right to highlight the need for more effective regulation for safety of medical devices and medication overall. I am pleased to support her amendment.