Medicines and Medical Devices Bill

Baroness Burt of Solihull Excerpts

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

[Baroness Burt of Solihull (LD)]

A lady local to me wrote to me about the excellent Cumberlege report. She said: “Mesh has ruined my life. I have lost my colon, appendix, cervix, uterus and parts of my vagina to mesh. I have been violated with at least two unconsented mesh procedures in my rectum and bladder—the scans don’t lie—and if I want removal, I may lose those parts of me as well. I have lost my sex life, my continence and my well-being. I have lost four jobs and I will shortly be losing my home since I cannot work.”

I shall call this lady Jane, which is my middle name, but it could be any woman in this Chamber or this country. Indeed, the online support group for women victims of mesh alone has over 8,000 members. Jane, like many others, has been brushed off, patronised and accused of imagining symptoms or being hysterical, while the perpetrators closed ranks, covered up their mistakes and made her suffer.

Vaginal mesh implants have caused women extreme pain, “like having razor blades inside them.” The noble Baroness, Lady Cumberlege, found in her report inadequately tested and poorly regulated meshes to be the cause of so much pain and misery. But the treatment of women over mesh, and the two drugs in her report, seem symptomatic of a culture of exasperation, impatience and disbelief on the part of many medical professionals when women tell them what they are going through. Barbara Ellen of the Guardian speculates about what would happen if the boot were on the other foot, and men had penis implants that felt like slashing razors. Would they be written off as “hysterics” and “whingers”?

Although I normally steer well clear of all matters medical, I cannot allow this Bill to pass without doing my utmost to ensure that women such as Jane, and all the Janes to come, will be properly protected from the inadequate testing of products, the failure to react and recognise when things are going wrong, and the cover-ups of life-ruining mistakes which have gone on without being called to account.

I am entirely in accord with the recommendations of the noble Baroness’s report and those of the Royal College of Surgeons. What we need in this Bill is proper traceability for all medical devices; a redress agency and revision of the MHRA; registries to monitor patient outcomes and spot early on if things are going wrong; and the setting up of a patient safety commissioner. Above all, we need to recognise the importance of giving primary regard to the safety of medicines and medical devices. This medical misogyny has to end.

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.

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.