A participants’ list for today’s proceedings has been published by the Government Whips’ Office, as have lists of Members who have put their names to the amendments or expressed an interest in speaking on each group. I will call Members to speak in the order listed. Members are not permitted to intervene spontaneously; the Chair calls each speaker. Interventions during speeches or “before the noble Lord sits down” are not permitted.
During the debate on each group, I will invite Members, including those in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will call the Minister to reply each time. The groupings are binding, and it will not be possible to degroup an amendment for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate. Leave should be given to withdraw amendments.
When putting the Question, I will collect voices in the Grand Committee Room only. I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an amendment is negatived, and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group. We will now begin.
95: Clause 16, page 9, line 18, leave out “may” and insert “must”
Member’s explanatory statement
This amendment is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill, setting up the new information system envisaged by Clause 16.
My Lords, this is a large group of amendments relating to expert registries. I have Amendments 95, 99, 100 and 101 and support the others in this group.
First, I welcome Clause 16, which the Government added during the Bill’s passage in the other place. The clause is a clear step in the right direction. Amendment 95, like Amendment 96, would build on this to ensure efficacy by tracking the use, and the outcomes from the use, of all medical devices rather than just a select few. We must not forget the conclusions of the Cumberlege review that registries are too
“few and far between and all too often prompted by catastrophe”.
The Bill provides a prime opportunity to move away from that position. Without tracking all devices, we will allow another scandal, involving an as-yet-unknown device, to emerge undetected until many have been affected. A proper warning system is essential.
Amendment 99 seeks to make the list of objectives for regulations listed under Clause 16(2) mandatory rather than permissive. These should be minimum standards against which to hold any regulations the Government publish, not just aspirations.
Amendments 100 and 101 then seek to add to that list of standards. In doing this in Grand Committee, I would welcome some commitments from the Minister, setting out where the Government share the objectives in those amendments. In essence, the difference between the Government’s approach and mine is that the Government foresee a future in which some medical devices continue not to be tracked, hoping that their outcomes will be audited. I strongly believe that this is a mistake.
Registries, which track patient outcomes through proper monitoring and audit, are an essential component of post-market surveillance and a prerequisite for patient safety. They should be the rule, not the exception. This is a principle that the Royal College of Surgeons of England strongly supports too. Indeed, its former president, Professor Derek Alderson, made this clear in his evidence to the review of the noble Baroness, Lady Cumberlege. As he put it
My Lords, I thank the noble Baroness, Lady Finlay, for introducing this group. As a surgeon, I will focus on the registries and, in particular, the National Joint Registry—the NJR—and the Breast and Cosmetic Implant Registry. The noble Lord, Lord Hunt, was Parliamentary Under-Secretary of State when the NJR was introduced in 2003, with the aim to
“improve surgery through learning from best practice, and … improve the quality of care to patients.”
The NJR is the largest of its kind in the world, with data from 3 million hip, shoulder, knee, elbow and ankle replacements. In the last year before Covid-19, nearly 200,000 hip and knee replacements were recorded. By analysing this information, surgeons are supported in choosing the best artificial joints for their patients. It helps surgeons decide whether their patients need to return to hospital by flagging up problems with a particular type of implant. I was lucky enough to have bilateral metal-on-ceramic hip implants. Had I received a metal-on-metal implant, I would be concerned, as the NJR in 2010 identified higher than expected revision rates for metal-on-metal implants, with metal debris damaging patients’ soft tissue and causing pain and loss of function. Without the NJR’s comprehensive registry, hospitals would be unable to track their patients’ progress and identify problems early. Similarly, the Breast and Cosmetic Implant Registry records implants used in patients, along with the surgeon and organisation responsible for the procedure, allowing patients to be traced in the event of a safety concern or product recall.
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As we were informed in the Minister’s useful briefing this morning, the NJR is able to capture details on patients, procedures, place or site, and the device with its product identification and unique identifier, thus allowing comparison with other devices that are underperforming. Amendment 100 adds four new paragraphs to Clause 16(2). They are subject to the patient’s consent and require that information about any medical device implanted in the human body is registered and retained in the information system outlined in Clause 16. The information system should be subject to expert review and, more importantly, patients should be empowered to enter reports of their experiences, following the use of medical devices in their treatment. The noble Baroness, Lady Cumberlege, identified this in her review and she will doubtless comment further.
In conclusion, I also support Amendment 101 in the name of the noble Baronesses, Lady Finlay and Lady Bennett. These amendments will give patients a voice and ensure that they consent to the information used about their care.
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.”
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.
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.
Baroness Masham of Ilton (CB) [V]
My Lords, Amendments 100 and 101 make clear that there should be means by which patients can report into registries directly so that they can be heard even if there is divergence of opinion with their clinician. Patients need to be protected. I support all the amendments in this group and thank those who tabled them, giving extra thanks to my noble friend Lady Finlay, who works so hard.
This is exceedingly important for many patients who have rare and complicated conditions. I speak from experience, as a high-lesion paraplegic. Many GPs and general doctors or surgeons may not be familiar with several of the peculiarities and may not understand the patient’s needs. For people with spinal injuries, for example, the three Bs are very important: bowels, bladders and bedsores. If not treated by specialists, patients can get into serious problems. Severely disabled people use all sorts of complicated devices that need to be kept on a register and to be easy to track if they go wrong. Suitable mechanisms should be found for the variety of needs, which can be inside and outside the body. This is particularly difficult in this time of Covid-19.
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The NHS is so big, and there are so many different bodies, that it is vital that patients should have a direct route to report their experiences into any information system with a clear remit. Plain English should be used and there should be clear translations into other languages, so that patients understand and are understood. Patients need to feel that they are having their voices heard, so that improvements can be made and mistakes will not happen to other patients.
I endorse the recommendations from the noble Baroness, Lady Cumberlege, in her report FirstDo No Harm. It is important that MHRA works closely with NICE, but I hope that it will also work with patients. Patients should be trusted: it is their life, and their hope for the future. The overriding need for better patient safety is, I hope, what this Bill will advance.
My Lords, I particularly welcomed the remarks of my noble friend Lady Burt, as they took me back to the days in the 1990s when I taught IT. I taught A-level students the differences between databases, tables and registers. I totally support these amendments about registries and databases relating to medical devices. They form one of the key recommendations of the review of the noble Baroness, Lady Cumberlege, in light of the scandals relating to, for example, vaginal mesh.
A huge number of patients have been affected by these incidents, and introducing registries allowing the use of implantable devices to be tracked, and allowing patients to view information relating to the data stored, would make a huge difference. Amendment 95, from the noble Baroness, Lady Finlay, changing “may” to “must”, is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill setting up the new information system envisaged by Clause 16.
Amendment 96, in the name of the noble Baroness, Lady Thornton, is a probing amendment seeking clarity about whether the Government intend to track all medical devices used in the UK, rather than a selection. Amendment 99, in the name of the noble Baroness, Lady Finlay, seeks to make mandatory the list of specified issues for regulations to cover. Her Amendment 100, to which I have added my name, would allow for the creation of a system of information regarding implants, with appropriate consents and oversights. It would also allow a patient’s experiences to be reported and stored; they should be subject to oversight. The noble Baroness, Lady Finlay, has also included the point about patient experience in her Amendment 101.
Amendment 104, in the name of the noble Lord, Lord Lansley, would require regulations under this section to have regard to the Caldicott principles. It was just over 20 years ago, when I was a non-exec director in a local NHS trust, that these principles were first introduced. I can remember the way that clinicians—in particular, senior clinicians—really welcomed the new measures. They certainly changed the way that clinicians thought about information and data. We are now moving through a different step change.
My Lords, this group concerns the need to set up information systems—registries—which will serve the purpose of tracking medical devices. I thank the Minister and the Bill team for their very enlightening and useful presentation this morning. The noble Baroness, Lady Finlay, and other noble Lords have already explained to the Committee how these registries and databases might work. The key point, which was made by the noble Baroness, is that they should be mandatory rather than permitted. Changing “may” to “must” so that the Secretary of State has to produce the information system envisaged by Clause 16 is a small but vital change. The Minister will need to explain to the Committee why, at this stage and after the experiences expressed and covered in the report of the noble Baroness, Lady Cumberlege, there should be any discretion in this matter.
The other amendments seek to ensure that patients have a direct route to report their experience to any information system established. Again, after the dismissal of so much patient experience over so many years in the cases outlined in First Do No Harm, it would seem to be the only way to guarantee that patient experience can be heard and registered.
Amendment 96 in my name is a probing amendment which seeks clarity about whether the Government intend to track all medical devices used in the UK, or just some of them. As other noble Lords have pointed out in the course of this Committee, if supermarkets have the technology and wherewithal to track the provenance of every single food product from anywhere in the world, we would need to understand why this would not be possible for medical devices.
Amendment 107 specifically addresses the issue of surgical meshes, and requires the production of a registry for patient safety. I hope that the Committee will be seeking to discuss registries and how they are linked. On Amendment 104 on the Caldicott principles, I do not see how anybody could possibly object to that.
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“a registry of its own right does not create patient safety; it’s just a list. The registry must contain information that can be audited”.
Essentially, as the Cumberlege review acknowledges, a registry is a registry only if it contains patient outcomes, which are then subject to expert oversight. To that end, Amendment 100, which is at the core of this group of amendments, sets out the following principles.
First, the use of all implantable devices should be recorded in a registry. That goes to the heart of the issues explored by the Cumberlege review and is surely the central lesson that must be learned from the unnecessary—and unnecessarily long—suffering of thousands of women whose experiences with mesh were horrific.
Secondly, other devices used in the course of operations should similarly be subject to outcomes tracking. I raise this in particular because it is not just devices left inside people that can later cause problems. We know, for example, that machines used in the heating and cooling of blood during open heart surgery can cause a Mycobacterium chimaera infection. The NHS now warns people of this risk, but it seems clear that the Bill should put in place measures to ensure that the use of particular machines is tracked, and that where infections develop later, a flag can be raised against that machine. To be clear, the machines involved do not actually make contact with the patient or their blood. The heater-cooler units contain two water tanks and tubing. One water tank uses warm water, which, through indirect thermal transfer, keeps the patient warm during the surgical procedure, often through the use of a warming blanket. The second water tank contains cold water, used, again indirectly, to cool the cardioplegic solution that slows or stops the patient’s heart to allow the surgical procedure to proceed. It is thought that where Mycobacterium chimaera develops in these machines, it can escape as aerosol—a fine spray—into the surgical area and thus cause infection from there. I raise the example simply to illustrate that medical devices are not only about what is left inside people, or even what comes into contact with people. The new provisions for information systems need to be flexible in recognising that.
The third provision of Amendment 100 is that information systems must be subject to expert oversight. That is to deal with the central point raised by the Royal College of Surgeons of England, which is that without this oversight a registry is just a list—not really a registry at all. A good example of a registry in action is the National Joint Registry, which is overseen by a steering committee of experts. The expert committee monitors outcomes achieved in joint replacement surgery, analysing procedures by brand of prosthesis, hospital and surgeon. Instances where performance falls below expected levels are highlighted to ensure appropriate investigation and follow-up. This is a standard we need to see replicated across surgical specialities and across the NHS.
Fourthly, and perhaps most critically, the amendment seeks assurances from the Minister that information systems set up under the Bill will provide a direct route for patients to report their own outcomes. Clinicians, of course, want to assume the best about the treatment they have commissioned and undertaken for a patient. It is a natural and not ignoble instinct to try to reassure a patient who presents with a problem following a procedure. There is human nature in a clinical transaction. When a problem emerges, patients are often reassured that they “need to give it more time” or “things will settle down”. Each GP may see only one or two patients who have been subject to a particular device or procedure. With follow-up appointments decreasing, these patients with problems can become invisible to secondary care. Yet the patients know that they feel worse, feel that they are not being properly listened to and speak to others in online communities, discovering a specific pattern of concerns.
The yellow-card notification scheme is greatly underused, and patients do not know how to self-report on it. For that reason, we need two ways for information to reach a registry. We hope that a majority will be tracked from patients, through clinicians. Where there are multiple instances of concerning outcomes, these should be flagged through expert monitoring, but there must be a failsafe for patients to approach the holders of the registry directly to have their outcome reported and considered in its monitoring. The fourth limb of Amendment 100 seeks to achieve this objective and Amendment 101 reflects the same principle. Together, the measures in Amendments 100 and 101 seek to implement this key conclusion of the Cumberlege review:
“A central patient-identifiable database should be created … This can then be linked to specifically created registers to research and audit the outcomes in terms of both the device safety and patient reported outcomes measures.”
That surely is the goal to which we must all aspire.
I want finally to address Amendment 104, to which I have added my name. The noble Lord, Lord Lansley, draws attention to the balances we have to get right in collecting all this data in the name of patient safety. As I said on a previous group of amendments, I hope and expect that dealing with consent to recording this data could and should be dealt with as part of shared decision-making between the clinician and the patient at the point of agreeing to a procedure. Of course, it should be open to a patient to have a procedure without the data being recorded, but they would have to be made aware of the increased risk to their own health if problems with a device used in the operation were later to arise.
I have sought to reflect this point in Amendment 100 by making clear that collecting data should be subject to patient consent. None the less, the noble Lord, Lord Lansley, offers another way to deal with the issue by putting in the Bill that regulations under Clause 16 should have regard to the Caldicott principles. I do not see how the Minister could argue with that and I hope he will be able to give a positive response.
This group of amendments is designed to assist the Government and to catalyse faster movement on their part. I understand that Ministers see tracking and auditing the outcomes from the use of all medical devices as the right direction of travel, but as yet we do not have a destination or an estimated time of arrival. We need to hear both from the Minister this afternoon. I beg to move.
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.
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.
Finally, my noble friend’s Amendment 107 would require the introduction of a registry for patients who have had surgical mesh implanted. Though I appreciate that this looks retrospective, there should be data held in hospital databases that could be imported into the new registry. It would then give a complete overview of surgical mesh implantations. It would require the Secretary of State to report on progress towards creating databases relating to other devices or implants and how they would lead to the creation of registries.
Like other noble Lords, we favour registries as opposed to databases because, according to the Cumberlege review, registries act as a repository for more complex patient-related information datasets, enabling research and investigation into patient outcomes. A database is really just a three-dimensional table held in store, but a registry is a richer, more useful resource than a database. However, often a database is required before a registry can be created, which is why our amendment is framed in that particular way.