Medicines and Medical Devices Bill

Baroness Finlay of Llandaff Excerpts

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

Moved by

[Baroness Finlay of Llandaff]

86: Clause 13, page 8, line 11, after “and” insert “unique device identification,”
Member’s explanatory statement
This amendment seeks to raise the issue of tracking of medical devices. Coupled with amendments by Baroness Finlay to page 8, line 17 and page 10, line 20, it would allow regulations to provide for the tracking of all devices via a Unique Device Identifier, as they are used, with the information recorded either in registries or through hospital episode statistics data.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I will speak to Amendments 86, 88 and 102, standing in my name, and in support of Amendment 103 in the name of the noble Baroness, Lady Cumberlege.

My purpose in this group is to underscore the critical importance of unique device identifiers in maintaining patient safety. Fundamentally, I ask your Lordships to reflect on the systems we have in this country more broadly, say in retail, for product recall where a safety issue arises. Let us say that a tumble dryer is found to be a fire risk, or a washing machine is liable to flood people’s homes: it is dealt with by a media campaign urging people who have the product, with the relevant model number and bought at the relevant time, to contact their retailer and the manufacturer directly. We may examine, as the Fire Safety Bill presently before the House illustrates, whether this system is adequate for domestic electrical products, but that is for another day.

This afternoon, I hope that we can agree that devices left inside human beings and used in their medical treatment should be subject to a more rigorous and effective product recall system than tumble dryers. Tracking is absolutely essential in order to ensure that, if a product is discovered to be faulty or to have adverse effects of some kind, others who have had that device used in their treatment can be contacted and, if necessary, examined.

What is more, we already have the technology in place to make this a reality. In July this year, Scan4Safety published an evaluation of six pilot sites where a system of scanning and tracking was used. At these Scan4Safety sites, all patients have a unique GS1 barcode on their wristband, which is scanned before a procedure. The system also involves scanning all equipment used for the procedure, including implantable medical devices, and the location in which the procedure takes place. At some trusts, staff have barcodes on their badges that they can scan prior to a procedure. The result is full visibility of what has been done to which patient, when and where. To quote the noble Lord, Lord Prior, who as chair of NHS England wrote a foreword to the report, this system means:

“The time taken to recall products falls to hours from days or weeks, clinical time is freed up—significant as the NHS continues to face workforce challenges—and effective stock management becomes straightforward.”


The system is good both for patient safety—providing complete traceability, speed and accurate recall, alongside reductions in drug errors and those terrible “never events”—and for cost and efficacy. It leads to cost-effective product ordering, more efficient staff with better staff well-being, the creation of accurate patient-level costings, and reductions in unwarranted variation. Across the six trusts, the pilot produced £5 million in recurrent savings and £9 million in non-recurrent ones. Perhaps more importantly, the system is said to have released 140,000 hours of clinical time back to patient care.

The purpose of my amendments is to adduce from the Minister—who I hope will be willing to help—an absolute commitment that the Government see rolling out Scan4Safety as the future of medical device use in this country, and that we will not have devices put inside people without a clear record, including of which surgeon put in the device, when, where and so on. We will come back in the group starting with Amendment 87 and Amendment 95 to talk about registries that track outcomes. They are an absolutely essential part of this picture. However, the bare minimum for registries to function is to have a full and accurate database of what devices have been used in procedures, and on which patients.

Amendment 86 addresses this issue directly by stipulating that the provision about unique device identifiers—barcodes—must be included in regulations on medical devices made under Clause 12 of the Bill and should be part of the thinking when it comes to packaging and labelling. Amendment 102 seeks to strengthen the later Clause 16 by making the regulations about unique device identifiers mandatory.

I will briefly address Amendment 103 on patient consent. The noble Baroness, Lady Cumberlege, and I are broadly aligned on this. Her report recognises the GDPR issues around recording data on patients and storing it in a database. She distinguishes between database, the subject of this group, and the registry, which is more complex and useful, and which we will discuss in a later group. There is an issue as to whether the database we are discussing here is subject to the same level of patient consent as a registry. In a registry, patient outcome data will be recorded, in addition to the simple fact of a device having been used. I will be interested to hear the Minister’s position on that, and I strongly support the idea in Amendment 103 that any distinction should be set out clearly in the regulations under this Bill.

For my own part, I would hope that the consent process and shared decision-making that are used between surgeons, radiologists and so on and their patients in deciding to go ahead with a procedure, could be used both to set out a routine action to make an entry in a database and to participate in more complex registries. We will examine the purpose of registries more thoroughly in subsequent groups. For this group, I hope that the Minister will respond by confirming a shared belief in Scan4Safety and set out a timetable for an equivalent scheme to be rolled out across the NHS. It is an approach which has the strong support of the Royal College of Surgeons and whose broad use around the country is long overdue.

I hope that the Minister will also ensure full consultation with the devolved Administrations to ensure that a system of coding is compatible with all systems across the UK. I beg to move.

[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.

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[Lord Bethell (Con)]

I can give a couple of illustrative examples if that would be helpful, but to run through the whole philosophy and system is probably beyond my ability or the time afforded by this Committee. In essence, the challenge identified by my noble friend Lady Cumberlege is that individual reports of adverse signals are not easily connected, unless those reports are somehow sent to a central registry and analysed by the kinds of experts who can spot mistakes and the connections made between those signals. This is how any problem identification system works. To do that process, you do not have to share personal details. You do not need the telephone numbers or personal identities of those concerned, but you need the clinical details and the full context in which signals have occurred. This pattern identification is often missing in the instances on which my noble friend reported. Having this information system, and analysis connected to it, will enable us to spot problems at a much earlier stage. Necessary interventions based on analysis and understanding will be much prompter and the connections made much more emphatic.

[Baroness Finlay of Llandaff (CB)[V]]

I am incredibly grateful to all noble Lords who have spoken in this debate. It has been very important and illuminating. We will all need to read the Minister’s words with care because there was an awful lot in them. I am most grateful to the noble Lord, Lord Ribeiro, for asking about the private sector, because if procedures are done in the private sector for patients who pay for themselves and those procedures are outsourced more and more, it will be important to make sure that this safety data is collected.

I am surprised that the word “must” is not being picked up. A supermarket will know how many tubs of mayonnaise it has ordered and which factory they came from. If there is glass in jam, a supermarket can track it back to the factory where the glass was. If we do not have complete data collection systems, we will find that all the places that are functioning above average will do really well. They will collect the data properly, and so on. But 50% of places are below the average line—that is the nature of an average. All patients need to be protected and standards need to be driven up. I was grateful to the noble Baronesses, Lady Walmsley, Lady Redfern and Lady Jolly, for elaborating on aspects of points that I have made, and particularly grateful to the noble Baroness, Lady Thornton, for giving us the history of the amendment and asking again how this would work in practice.

Consent is critical. Patients going into a hospital expect all the equipment to be safe and to be known about. They expect the fire alarms to work and that the oxygen pipes to anaesthetic machines are correctly positioned and known about, and that full servicing data is available. It is important. Here I should declare that I was a very junior doctor in a hospital, but on the periphery, when an anaesthetic accident happened many years ago. It was critical that things could be traced back urgently. Unfortunately, there are tragedies, even when it is possible to do that.

We need to be able to look right across the whole system. There is the safety aspect—the tracking and quality control—that goes along with all the routine procedures. If something faulty is used in 15 hospitals around the country, that needs to be known rapidly and safely. I, too, worry about relying on clinicians to report if there is a problem, and I rather felt that the Minister’s answer underlined the call for a distinct commissioner for safety. The noble Baroness, Lady Cumberlege, has been calling for that because we need somebody who can interrogate and analyse the data, and look at it carefully. She explained consent for patient details extremely well. The Montgomery test of consent is that you should be given the information that other reasonable people would expect. It is almost the Clapham omnibus test of what patients should be told.

This is not about what the clinicians want or do not want to tell patients. They might feel it unnecessary to tell them something, but most patients would want to know about it and therefore it should be disclosed to patients. A doctor might say, “This can happen, but it has never happened to me”, but they still have a duty to disclose. Linked to that consent, I would like us to have routine processes in clinical practice for consent data to be entered into a registry. Patients could opt out and say that they did not want it to be entered, so that box would not be ticked; their scanned-in data would then not be sent on with the additional information.

This debate has been incredibly important. It gets right to the nub of patient safety. I hope that the Minister will meet me and the noble Baroness, Lady Cumberlege. I have to say to the Committee that I am pretty convinced that we will return to this on Report because there is a lot more to do. However, we have another group of amendments to move on to, and that debate will be interesting and informative, so I beg leave to withdraw the amendment.

Amendment 86 withdrawn.

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[The Deputy Chairman of Committees (Lord Lexden) (Con)]

We now come to Amendment 91A. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. I call the noble Baroness, Lady Finlay of Llandaff.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I beg the indulgence of the Committee for just a moment because I have a horrible feeling that I have lost my place. I had thought that we were moving to Amendment 95. Perhaps the chair would be kind enough to set me right on that.

[The Deputy Chairman of Committees (Lord Lexden) (Con)]

I propose that we adjourn for five minutes.

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Moved by

[Baroness Finlay of Llandaff]

91A: After Clause 13, insert the following new Clause—
“Innovative Medical Devices Fund
In section 261 of the National Health Service Act 2006, after subsection (9) insert—“(9A) The Secretary of State must make a scheme to promote the availability of innovative medical devices for human use within the National Health Service and must provide monies paid to the Secretary of State under subsection (9) for the benefit of that scheme to be known as the “Innovative Medical Devices Fund”.”

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I am most grateful for the kindness of all your Lordships. Lacking having all those wonderful papers in front of me really showed. It is the first time that I have missed walking into the Chamber with a large stack of papers.

Amendment 91A builds on the concept that we had in the previous debates of an innovative medicines fund, which had been carefully thought through, including how it was to be financed. It struck me then that we have fantastic potential in medical engineering in this country to develop new and innovative medical devices. I should declare an interest because my son is involved in developing devices for use in cardiology, for oblation procedures and so on.

The real issue, as the Minister pointed out in the previous debate, is about developing a piece of equipment which is a custom-made device, for one reason or another. When that happens it can turn out to be, serendipitously, something that solves a problem for clinicians in undertaking a procedure of some sort. However, when that happens, if it is a small clinical team in a district general hospital, it will not be linked into a commercial enterprise and funding its ongoing development is extremely difficult.

In previous debates, I referred to the investment that went on in Ireland—in Galway—to create an innovation hub and ensure that there is investment in innovation. This amendment would allow the Government to explore having a medical devices fund similar to an innovative medicines fund, and would allow that fund to be used to develop a device and test and trial it within the NHS, with it being available to NHS patients and clinicians much more rapidly than the current procedures require. It does not in any way suggest that the usual ethical approval processes and all the checks that go with it should be curtailed; it would simply be a way of making sure that, where a custom-made device that solves a major problem could be rolled out widely, it can be used for the benefit of UK plc, if you like to call it that. It would make sure that we have that investment, and that the clinicians do not have to give it away for the whole thing to be developed commercially elsewhere and then sold back to the NHS at huge cost. I again express my gratitude to the Committee and I beg to move.

[Lord Lansley (Con)]

My Lords, I am grateful to the noble Baroness, Lady Finlay of Llandaff, for tabling and moving this amendment for a number of reasons, the first of which is that it allows me to express my appreciation to the noble Lord, Lord Patel, for moving Amendment 28, in his name and mine, last week on the innovative medicines fund and to say how much I welcomed the debate on it, which I have read, and the Minister’s response.

I am also grateful to my noble friend the Minister for his subsequent letter about the innovative medicines fund. There is of course a direct parallel in that Amendment 91A would look for the innovative medical devices fund to be funded in a similar way. I just gently dispute one proposition with my noble friend: he said that the use of the rebate on the voluntary pharmaceuticals access scheme would not be appropriate for the innovative medicines fund because the amounts could vary sharply from one year to the next. This would be a problem only if there were a direct hypothecation for the amount, and that is not necessarily implied. The amount of the innovative medicines fund could be established as a fixed amount that would then be funded by the rebate or, in the absence of a rebate, by the Exchequer or though NHS England’s total budget. It would not necessarily rise or fall with the rebate. The same would of course be true for the innovative medical devices fund.

There is a central proposition that supports both an innovative medicines fund and a medical devices fund; it is not that we in the United Kingdom lack innovation, it is that we lack the adoption of innovation in the National Health Service. That was the starting point for the Cancer Drugs Fund, on which this proposition is based. The Cancer Drugs Fund arose, in policy terms, from an analysis by Professor Mike Richards, who was then the cancer tsar under the last Labour Government, that there was a significant lack of availability of the latest cancer medicines for cancer patients, compared with other, principally European, countries. At the time that was not true for some other disease groups and medicine available for other diseases. It was a problem particular to cancer.

Why does this happen? It is not simply about funding; there is a systematic issue here, separate from the amount of resource, which is that the United Kingdom has a single-payer system. A single-payer system necessarily makes decisions about the availability of medicines on the basis of the whole system moving together. I suspect the same is true for devices. Pretty much all of the other European systems are not single-payer systems, but insurance-based systems, where, essentially, clinicians advise, patients choose and insurers pay. That brings innovations into use much more rapidly. There is potentially a problem with the diffusion of innovation in the NHS, which we have seen before and we have to continually guard against.

I put this question to the Minister for when he responds to this debate: are patients in the NHS getting access to new, effective medical devices as quickly as patients in other countries? I do not know the answer to that. I am absolutely clear that there was a good case for the Cancer Drugs Fund. I am clear that there is a continuing need for the innovative medicines fund, because there is sometimes a continuing gap between the availability of the most effective new medicines here and in other countries. I do not know about devices.

To this extent I offer an apology to the noble Baroness, Lady Finlay of Llandaff, because a medical devices fund might be premature, in the sense that we do not know to what extent there is a gap in the adoption or diffusion of innovation where medical devices are concerned. We identified real potential in the previous debate on Amendment 85 about the funding mandate for medical devices. If that is rolled out, as I think is the intention, and extended to a faster and larger pipeline of medical devices going through the NICE evaluation process, then we may find there is not too much of a problem. There may well be a case for understanding to what extent medical devices are being adopted by the NHS, relative to other health economies. I hope the Minister will agree that is worth looking at.

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[Lord Bethell (Con)]

My Lords, Amendment 91A seeks to replicate the innovative medicines fund with a comparable fund for medical devices called the innovative medical devices fund. We have had a terrific debate on this. The ideas and insights shared by noble Lords have been extremely powerful, but perhaps I may address the points in turn.

The goal that is shared wholeheartedly by the Government is that we recognise the huge benefits that medical devices can deliver. My noble friend Lord Lansley and the noble Lord, Lord Hunt, put that particularly well. We recognise the astonishing pace of innovation and development that is creating new healthcare options for patients across the UK. In fact, that is one of the reasons we are considering this Bill. We are extremely ambitious and are determined to capitalise on the opportunities presented by new medical technologies to ensure that the best innovations are adopted and spread across the NHS.

Devices, like medicines, are key to ensuring patient health, but they are different and it is not necessarily helpful to use a system that was developed for medicines to be used for devices. For example, the primary purpose of the innovative medicines fund is to cover the cost of managed access agreements where NICE feels that there is insufficient evidence to give a positive opinion and asks for further evidence to be collected before the product is re-evaluated.

Devices are not assessed by NICE in the same way and we do not consider that mirroring the provisions for medicines would necessarily be beneficial. In particular, unlike medicines where, once licensed, they do not change, medical devices are constantly evolving. New iterations of medical devices are developed quickly, their impact on patients changes, often rendering earlier iterations completely obsolete within relatively short periods of time. That gives rise to the potential for funding mandates to be in place for devices that are no longer the best or most cost-effective in their category. Requiring the mandatory purchase of all but the most innovative devices by commissioners would not be a sensible use of NHS funds. We therefore need to find different systems of process to ensure that innovative and effective devices, along with other medical technologies such as digital, find their way to the NHS and to patients.

That is why we have boosted the remit of the Accelerated Access Collaborative. It will bring together leaders from across Government, the NHS, regulators and industry to address the underlying challenges that delay patient access and uptake.

As chairman of the AAC, the noble Lord, Lord Darzi, has been able to bring his world-leading expertise to bear to deliver a host of successes in recent years. Indeed, almost 750,000 patients have benefited from access to AAC-supported innovations in recent years, including more than 315,000 patients who have accessed new technologies supported through the innovative technology payment programme. The AAC is going further to deliver the commitment in the NHS Long Term Plan to accelerate the uptake of proven, affordable innovations with the introduction of a new medtech funding mandate. The mandate will ensure that all patients have faster access to selected cost-saving devices, diagnostics and digital products approved by NICE, via medical technologies guidance and, when available, NICE diagnostic guidance for innovations.

The final criteria to be used in the mandate will be announced in the consultation response to be published in December this year, and the mandate will take effect from April 2021. Additional steps are being taken to ensure that the mandate translates to front-line improvements in patient access. The NHS standard contract has already been updated to state that the relevant parties must comply with their obligations under the mandate guidance, and technologies receiving the mandate will benefit from dedicated support via the regional academic health sciences network to help drive local adoption and spread.

NICE also recognises the need to ensure its methods for assessing innovative medical technologies continue to support our ambition for the NHS to provide world-leading care that delivers value to patients and the NHS. The NICE methods review is therefore under way, with extensive input from industry and patient representative groups. The consultation on the case for change to existing NICE methodology is open until 18 December, and I encourage all those interested to submit their views.

Finally, it is also important to note that in her amendment the noble Baroness, Lady Finlay, stated that moneys should be paid to the Secretary of State under Section 261(9) of the National Health Service Act 2006 in order to support an innovative medical devices fund scheme. However, Section 261 of the National Health Service Act relates only to voluntary schemes agreed with pharmaceutical manufacturers which control the prices charged, or profits accrued, by manufacturers and suppliers of health service medicines. The vast majority of medical devices would not therefore be within the scope of such a scheme.

I trust that I have been able to reassure the noble Baroness that the funding of medical device technology in the NHS in England is of great importance to the Government and that we are actively putting in place mechanisms to support it. On this basis, I hope very much that the noble Baroness, Lady Finlay, will feel able to withdraw her amendment.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I thank noble Lords for contributing to this debate. There were a couple of comments that I would like to come back on.

The noble Lord, Lord Lansley, asked whether there was evidence of the slow adoption of innovation. I have a series of different case studies that I will happily share with him. I shall highlight one. Cytosponge had a 19-year journey from when it was thought of to when it was adopted. It is estimated that it saves 7,190 QALYs having now gone through NICE. Companies do not feel incentivised to develop low-cost devices in this country.

Another example is the CoMICs study on conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery, which compared two types of bypass machines. The difficulties there resulted in most of the study going abroad and being conducted elsewhere. Our development of robotics has been impressive, but we have huge competition from the US market, in particular in device development.

So I suggest that we need to look at a way of making sure that we can develop devices. I accept that this amendment as worded may not be right for this Bill at this time, but I hope that we will not lose sight of the need to innovate. I would like to come back on Report to the concept of provisional licensing as a way of getting new and innovative devices through the system rapidly, possibly without burdening the NHS with the financial bureaucracy that this amendment might cause. I beg leave to withdraw the amendment.

Amendment 91A withdrawn.

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[The Deputy Chairman of Committees (Baroness Watkins of Tavistock) (CB)]

I have received requests from three noble Lords to speak: the noble Baronesses, Lady Finlay, Lady Walmsley and Lady Thornton. I call the noble Baroness, Lady Finlay.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I am most grateful to be able to come in at the end of this important short debate. I particularly commend the noble Lord, Lord Field of Birkenhead, for his outstanding and long history as a parliamentarian and, yet again, for his clarity and ethical approach to every subject that he addresses.

I am glad that the Minister has referred to the two studies from the NIHR and simply support the idea that we need to wait for those, although I draw attention to the fact that, in 2018, there was a Cochrane database review, which looked at the 16 double-blind randomised control trials that it could find. It found some support, but it was not terribly strong. One of the difficulties here is that pain is a symptom that occurs in an enormous range of disorders, but the fundamental cause of the pain will be very different in different people. To get a matched population where you can compare one with another is extremely difficult. I hope that the change that NICE is looking to in the evidence that it seeks, where it will also look at evidence in practice, will support the evidence coming through from large patient cohorts who can then be put into broader groups.

The other point about pain is that, as people get multiple pathologies, they often take several other medications as well, which can interfere with the ability to assess them. They are also often elderly. The evidence certainly needs to be accrued. I would say as a clinician that one worry was always whether there would be a leak of cannabis on to the streets. However, in practice, I think that the leakage has gone other way so that it comes from the streets into people’s homes. Clinicians have had to look at this with Nelson’s eye because they do not want to support clinical activity. In a study that I did, while we did not ask patients to tell us specifically where they were getting some things from, when we put together all the different types of alternative therapies being used by a group of people who were cancer patients, the numbers were huge. This supports many of the comments that have already been made. I am glad that the Government are looking at it and I expect that it will not be too long before we find that the ability to get the medication that is needed is made easier. I worry that it may be too late for some patients, but we are getting there.

[Baroness Penn (Con)]

I thank the noble Baroness for her comments about the importance of evidence. The Government and the MHRA recognise some of the difficulties around these trials. That is part of the reason that NIHR is supporting two trials and is asking people to come forward. The MHRA has also indicated that it is willing to work with those who have these products in order to support them in the process for licensing.

That has reminded me of one other point. The noble Baroness, Lady Walmsley, asked me about the NHS commissioning through evaluation programme. I undertake to write to her with a response, perhaps when I update the noble Baroness, Lady Thornton, on prescription numbers.

Covid-19: Dental Services

Baroness Finlay of Llandaff Excerpts

Tuesday 10th November 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, my noble friend is right to allude to the confusion around the closure of dental practices. We have made it crystal clear that in the second lockdown all dental practices—both NHS and private—should remain open; that is part of our commitment to try to clear the backlog. I also acknowledge her concerns about the diagnosis of cancers. I do not have the figures for which she asked, but we certainly appreciate the role that the dental sector plays in detecting many cancers, including oral cancers. Dental services are open to those seeking urgent care and we hope that those urgent care clinics to which I referred earlier can provide some diagnostic analysis in urgent cases.

[Baroness Finlay of Llandaff (CB) [V.]]

My Lords, I declare my role as chair of the National Mental Capacity Forum. Following on from the question of the noble Baroness, Lady Uddin, will the Minister say how the urgent care pathway is being evaluated, particularly for children and young people with learning difficulties who might need a general anaesthetic for dental work? They are at a particularly high risk of sepsis from dental abscess, which can be avoided by preventive dentistry, yet they are often part of the increasing backlog and have difficulty registering with a dentist locally because they need even more time for their care than other patients and will therefore decrease the number of other patients whom the dentist can see.

[Lord Bethell (Con)]

My Lords, the concern about children is particularly acute. We are especially keen to encourage parents, to ensure that they are still bringing children forward. That is why we have the Help Us to Help You campaign to encourage public access to NHS services. She is entirely right that acute situations—involving, for instance, some form of anaesthetic—provide a particular challenge. We have a prioritisation process in place, and I understand that that is working well to ensure that those who have the greatest need are put at the front of the queue. However, as I said to the noble Baroness, Lady Uddin, I would welcome any feedback from those who think that the system is not working well enough.

Medicines and Medical Devices Bill

Baroness Finlay of Llandaff Excerpts

Committee stage & Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wednesday 4th November 2020 Grand Committee

[Baroness Wheeler (Lab)]

My Lords, I support this amendment from the noble Lord, Lord Patel. It is very much the ambition to ensure access for UK patients to the latest and most innovative treatments. This is reflected in many of our amendments to this Bill, relating to attractiveness, clinical trials and regulatory alignment with the European Medicines Agency.

We fully support the Government’s commitment to extend the Cancer Drugs Fund into a £0.5 billion innovative medicines fund to be used for

“the most advanced, life-saving treatments for conditions such as cancer or autoimmune disease, or for children with other rare diseases”.

If, at last, the principle of using the rebates from the pharmaceutical rebates scheme could be achieved so that they are used for the benefit of the NHS and patients, then this will represent progress indeed, particularly ensuring that the money is used as an additional source of income and revenue for the NHS and is not part of expected and planned funding.

Like other noble Lords, we are very much looking forward to hearing from the Government the detail of their proposals, when they intend to commence the promised consultation and the proposed timetable for implementation.

We heard in previous debates important questions as to how the new fund will relate to the current NICE process for reviewing new cancer drugs, particularly those to treat rare cancers, and, more broadly, around what drugs will qualify, outside of cancer, to be covered by the new fund. For example, there may be candidates from medicines selected for the early access to medicines fund, the MHRA’s pre-licensing indicator of promising innovation, allowing them to be funded while further evidence is generated. Given the focus on innovation and the very reason for EAMS to designate a drug as a promising innovative medicine, a prerequisite for any drug to get a full, positive EAMS designation, what consideration have the Government given to this?

Detail, too, is needed, as we have heard, on the criteria that will apply to any prospective drug for the fund. I certainly endorse the comments of the noble Lord, Lord O’Shaughnessy, on needing to have an ambitious definition of innovation. Will the criteria mirror the current processes that the NICE committee considers for funding under the CDF, or will it be widened to reflect and include some of the criteria for highly specialised technologies, where NICE takes a different approach to treatments for some of the rarest conditions?

One of the key concerns in earlier discussions in Committee was the need for reassurances about NICE’s work to support innovation and to ensure that the current NICE review of its methods and processes is open and transparent and delivers real and effective change. As was made clear, it is important that we learn lessons from both the strengths and criticisms of the CDF, and that we ensure speedy access to new medicines going forward. I look forward to the Minister’s response.

[Baroness Finlay of Llandaff (CB) [V]]

I thank the Committee for allowing me to come in a bit late; I apologise for that.

Noble Lords have made the main points that I would have made but I simply add this. A large number of molecules are held by pharma, often with a good scientific rationale, for use in a rare condition, and we have drugs that are licensed for other uses that could be reused or repurposed. If we can speed up all these processes, and provide an incentive for medicines development, those with rare conditions—who are often absolutely desperate to try something new and very keen to be part of a monitored development—could access medicines. That would put the UK in a stronger position in the long term.

In addition, the concept of this seems so sensible that I have also put down an amendment, later in the Bill, to try to replicate it for innovative devices. We have complex situations where medical engineers may come with up a device, but we will deal with that the next time round.

In the meantime, I am most grateful to all noble Lords for the important points they have made. I await the Minister’s reply with interest.

[Baroness Penn (Con)]

My Lords, this debate has once again focused the Committee’s mind on the importance of innovation and the way in which it can have a transformative impact on patients’ lives.

As noble Lords have spoken of, the success of the Cancer Drugs Fund in providing interim funding means faster access to cancer drugs, saving valuable time—up to eight months in some cases—for patients accessing those drugs. Patients are now able to access cancer drugs that have received a draft NICE recommendation from the point of marketing authorisation. As noble Lords have noted, this provides the template for the innovative medicines fund.

The success over the lifetime of the Cancer Drugs Fund to date did not need legislation. It was a response to the immediate need to target access to cancer drugs. In expanding the fund to become the innovative medicines fund, I do not think legislation would advance the fund’s purpose, capacity or delivery in any material way. It will be a managed access scheme delivered by NHSEI and NICE to expand the range of medicines that could be supported by that funding.

I understand that my noble friend Lord O’Shaughnessy and other noble Lords would like this debate to cover an update on progress towards delivering that fund. I assure noble Lords that proposals for the innovative medicines fund are in development as we speak. We know that patients will be keen to understand the impact on them, as well as pharmaceutical companies and the NHS. It is our intention that NHSEI and NICE will lead an engagement exercise in the first quarter of 2021 to get the fund established.

Covid-19: Contracts and Mass Testing Programme

Baroness Finlay of Llandaff Excerpts

Wednesday 4th November 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I do not accept the assumption that we are going into a second lockdown because of the failure of tracing. The tracing system has led to the isolation of more than 1 million individuals, which has done an enormous amount to break the chain of transmission. However, there is more that we could do. I completely acknowledge that the Government are focused on improving performance in tracing, and we will use the opportunity of the next month to ensure that that performance gets better.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I declare my interests in medicine. Given that 55% of GPs, 35% of physicians and 11% of surgeons recently reported that they lack confidence in adequate PPE being available during the ongoing pandemic, when will the Government issue revised guidance to all NHS managers insisting on a duty of care to all front-line staff to ensure that staff are supplied with quality-certified appropriate PPE that is in date and fit tested under a risk assessment for the well-being of the clinical workforce? Have the Government commissioned research into reusable UK-manufactured PPE?

[Lord Bethell (Con)]

My Lords, we take the duty of care to our staff and patients extremely seriously, and that is already well documented by the NHS. I reassure the noble Baroness that purchase orders have been raised for 32 billion items of PPE in anticipation of a second wave; 18.6 billion items have already been delivered, 2.2 billion are with our delivery partners, and a further 16 billion are on their way. This is a massive investment in PPE and I reassure her that it will be made available to healthcare staff in abundance.

Medicines and Medical Devices Bill

Baroness Finlay of Llandaff Excerpts

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

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, the world is increasingly aware of China’s forced organ harvesting from prisoners of conscience. This horrific crime of forcibly removing the organs from living victims—the process leading to inevitable murder—has recently been found by the China Tribunal to be happening extensively. The organ recipient may have had their life saved, but at the expense of another innocent life. It is now a multimillion-pound commercial business in China, with wealthy Chinese officials, Chinese nationals and organ tourists receiving treatment in high-end recovery centres.

Evidence of forced organ harvesting has grown and whistleblowers have emerged. Millions of Chinese citizens are currently detained in labour camps. UN experts estimate that at least 1 million Uighurs are being held in camps in the region of Xinjiang. Elsewhere throughout China, other ethnic and religious minorities such as Tibetan Buddhists, Falun Gong practitioners and Christians are also being held in labour camps. Companies from the West are complicit in this. Adidas, Nike, Zara and Amazon are among the western brands which, according to a coalition of civil society groups, currently benefit from the forced labour of Uighurs in Xinjiang. In July this year, a 13-ton shipment of hair products from Xinjiang, worth more than $800,000, was seized by US Customs and Border Protection. This shipment included wigs made from human hair, which is hugely concerning considering the many reports and personal testimonies of female Uighur Muslims having their heads forcibly shaved in the camps.

Last year, the China Tribunal, chaired by Sir Geoffrey Nice QC, concluded:

“forced organ harvesting has been committed for years throughout China on a significant scale and that Falun Gong practitioners have been one—and probably the main—source of organ supply.”

and that:

“In regard to the Uyghurs the Tribunal had evidence of medical testing on a scale that could allow them, amongst other uses, to become an ‘organ bank’.”


I point out to the Grand Committee the vast body of evidence of forced organ harvesting in China. Such evidence includes: detailed statistical analysis of transplantations and donations; numerous recorded undercover telephone conversations, including with well-known Chinese officials admitting to the practice of forced organ harvesting; legal and policy statements and practice of the CCP; advertisements and admissions of university and military personnel; incredibly short waiting times; and a large number of personal testimonies. The China Tribunal spent 12 months assessing all available evidence. Additionally, its international panel of highly respected individuals interviewed over 50 witnesses, experts and investigators, and formally invited representatives of the People’s Republic of China to respond. I do not believe it is sufficient for the UK Government to ignore this any longer.

Although Ministers have been personally sympathetic, so far the Government have relied on the World Health Organization’s view that China is implementing an ethical, voluntary organ transplant system. I am afraid this is simply not credible; the fact is that it is based on a self-assessment by China, as became clear during my noble friend Lord Collins’s PQ on 29 June 2020. The WHO has not carried out its own expert assessment of China’s organ transplant system, so I am afraid that the WHO cannot be considered reliable in this area. For me, the China Tribunal is persuasive on this point.

This Bill provides an opportunity to prevent British complicity in such crimes and to send an important signal to other countries. Currently, the Human Tissue Act does not require appropriate consent for imported human tissue. In addition, imported human tissue for use in medical research does not require traceability. The Minister has written to me to state that whether sourced from within or outside of the UK, there is comprehensive domestic legislation to ensure the ethical and appropriate use of human tissues. Yet while this is all true for human tissue sourced from within the UK, this does not address the gap in legislation for imported human tissue. On the concern about the use of human tissues in the development of medicines, which I do understand, the Minister commented that the use of imported tissue in any medicines on the UK market is very limited. However, while it may be limited, there is a gap in the legislation which could be exploited in the future.

I am grateful to the noble Lord, Lord Ahmad, for his awareness of the passion which many of us feel about the allegations of forced organ harvesting in China and for ensuring that the UK is not complicit in any way. I hope that he will acknowledge that my amendment—which has been signed by a number of very distinguished colleagues— is not prescriptive and essentially gives Ministers regulation-making powers to deal with the issue if and when they decide to do so.

Up to now, we know that many countries have pulled their punches when talking to China about these practices. Of course, as The Economist has pointed out, China’s economic power has helped it to avoid censure regarding its abuse of the Uighurs. Many companies in the West appear reluctant to use any leverage they may have to put pressure on China, and that is not helped by the reluctance of so many countries to upset that country. The UK, of course, faces dilemmas too, and we have seen them already in the issues over 5G and potential Chinese investment in new nuclear energy. I am not naive; I understand some of the pressures which are on the Government, but there must be a time when we make a stand.

I was encouraged by the reported words of Dominic Raab to the Foreign Affairs Select Committee on 6 October, when he referred to evidence of “gross human rights violations” against the Uighur Muslim minority in Xinjiang province. I pay tribute to the Government for being prepared to say that. I simply want them to go one step further, and agree to a very modest amendment. It seeks to give Ministers the powers to take action when they deem it right to do so. Accepting it would be a very important signal of this country’s attitude to gross human rights violations, and I have great pleasure in moving my amendment.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, it is a great privilege to follow the powerful speech of the noble Lord, Lord Hunt of Kings Heath.

While the Human Tissue Act 2004 is thorough and comprehensive with regard to human tissue sourced from within the UK, this does not hold true for imported human tissue. Human tissue can be imported into the UK without any consent or traceability. Notably, if it is for use in medicines, traceability is required through the Human Tissue (Quality and Safety for Human Application) Regulations 2007, but for use in medical research neither consent nor traceability is required. They are merely considered good practice. This means that human tissue sourced from China—where people are imprisoned and tortured, and where organs are extracted and sold for profit, a process which kills the donor—can legally enter the UK and be used in medical research.

Health Protection (Coronavirus, Restrictions) (Self-Isolation) (England) Regulations 2020

Baroness Finlay of Llandaff Excerpts

Thursday 22nd October 2020 Lords Chamber

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, these regulations read as punitive. Currently, around 18% of people self-isolate after developing symptoms, but only 11% of people in contact with them quarantine for 14 days. It seems that one in 10 with Covid is a high spreader, inadvertently passing the virus to around 80% of the subsequent cases. Containing these outbreaks requires very rapid testing and tracing, because in two and a half days each will have doubled in size.

Non-adherence is associated with men, younger age groups, having a dependent child at home, lower socio- economic grade, greater hardship during the pandemic and working in a key sector. We hear of those who cannot miss work for financial reasons, whose housing makes self-isolation impossible, whose caring responsibilities mean that self-isolation would cause disproportionate suffering for others, whose mental health and welfare are deteriorating, or whose cognitive difficulties mean that they cannot understand why they are being punished by being kept away from the activities and people they depend on.

Crippling fines and a police record will only disincentivise people to seek testing and disclose their contacts. The criteria behind the instruction to self-isolate are not transparent and there is no appeal mechanism for those who feel they have been inappropriately instructed. That runs counter to the principles of co-production and the findings from the CORSAIR study, which showed that practical support and financial reimbursement, with targeted messaging and clear policies, are likely to improve adherence. Punitive measures set up blame and division, not supportive collaboration. Any instruction must help people understand the benefit to them and those they care for, not jeopardise health by driving people to conceal their symptoms I am sure that is a risk that our hard-working Minister recognises and does not want to take.

Cancer Task Force

Baroness Finlay of Llandaff Excerpts

Tuesday 20th October 2020 Lords Chamber

[Lord Bethell (Con)]

My noble friend is entirely right. The impact on cancer from Covid is extremely concerning. However, the backlog is being dealt with more quickly than the immediate figures perhaps suggest. The investment in radiotherapy is incredibly important; we have new treatments coming in all the time, and I reassure my noble friend that we will be retiring redundant machines as soon as they reach the end of their natural lifespan. I want to mention in particular stereotactic ablative body radiotherapy for small cell lung cancer and oligometastatic indications: I am told that this is a particularly exciting radiotherapy treatment

[Baroness Finlay of Llandaff (CB) [V]]

Following on from that, does the Minister recognise that about half the machines in the country are currently beyond their 10-year lifespan and urgently need replacing—including upgrading to provide stereotactic radiotherapy, which has lower side effects and better outcomes—and that there therefore needs to be at least £230 million ring-fenced for innovation in radiotherapy, quite apart from the other investments?

[Lord Bethell (Con)]

The noble Baroness puts her case extremely well. We have a massive investment in the NHS that spans physical infrastructure and staff, hospitals and investment in nurses. This will have a big impact on the diagnosis of cancer, which we are committed to getting as early as possible, as well as on treatment for cancer. Treatment with radiotherapy will form an important part of that.

Health Protection (Coronavirus, Local COVID-19 Alert Level) (Very High) (England) Regulations 2020

Baroness Finlay of Llandaff Excerpts

Wednesday 14th October 2020 Lords Chamber

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, government gets harder by the day, but the released SAGE report is shattering because all that it predicted is being seen. Will the Government use half-term as a circuit break and stress, over and over again, the two-metre rule for all places, avoiding indoor shared workplaces?

How many complaints have been received about test and trace? With local lockdowns happening, is all testing and tracing now being handed over to local public health with a transfer of funds from the current outsourced system? Is accompanying the seriously ill and dying still allowed, especially if the relatives have either had Covid clinically or want to take the risk? The guidance seems silent on this. The mental health harm of banned visits will haunt us for years. I declare that I chair the Commission on Alcohol Harm; we have heard how pushing alcohol consumption into homes with cheap supermarket booze pushes up domestic violence.

What of the app? Some 79% of adults are thought to own smartphones, but the figure falls to 40% for the over-65s, and not all smartphones are compatible with the Test and Trace app. In tier 3 areas, what proportion of the population have a smartphone that is compatible with the Test and Trace app versus the old NHSX app? Of the 1.5 million QR codes registered with the Test and Trace app, why has only one notification to isolate been sent? Is the app failing? How much money has been spent on trying to get this Google/Apple app to work?

Two-metre distancing, proper mask wearing, soap to wash hands and a circuit break will be far cheaper in the long run and could cost fewer jobs and fewer lives.

Health Protection (Coronavirus, Wearing of Face Coverings in a Relevant Place and on Public Transport) (England) (Amendment) (No. 2) Regulations 2020

Baroness Finlay of Llandaff Excerpts

Monday 12th October 2020 Lords Chamber

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I declare that I am on the BMA ethics committee. I want to consider what we know, what we are doing and where our duty in society lies.

Masks are increasingly reported to be protective. I thank the Minister for his brief summary, but I add to it that no evidence has emerged that they are harmful in Covid transmission. The coronavirus is tiny, 0.1 micrometres across, less than one-800th of a human hair in diameter, but it does not leave the body on its own; it relies on aerosols and droplets to spread, and it goes however far that mist takes it. Think of tobacco smoke spreading; once you get beyond two metres and are not downwind, you are less likely to inhale much of it, even though the aerosol lingers in the air for a long time. Do not forget that in indoor spaces that can be for many hours, which is why the BMA wants masks worn in offices even when alone.

This aerosol, often minute droplets of around double the width of the virus itself, is partly caught in the fibres of a mask. Masks made of double layers of tightly woven mixed fabrics, such as silk and fine cotton, seem to decrease aerosol transfer by up to about one-fifth. The standard mask for use in healthcare settings with aerosol-generating procedures is the N95 respirator mask, which is designed to protect the wearer by filtering out 95% of airborne particles that measure 0.3 micrometres or larger. A review of observational studies estimates that such surgical and comparable cloth masks are around 67% effective in protecting the wearer. That figure may be even higher for the G variant of the virus that seems to transmit faster, but we do not yet know that.

The other protective effect of a mask is that it can cut the viral count inhaled by up to 60%. Where masking reduces the dose of virus that a wearer might receive, it seems that the resulting infection is milder or even asymptomatic, whereas a large viral load results in a more aggressive inflammatory response. So wearing the suitable mask protects the wearer as well as protecting others if the wearer is excreting virus. In Hong Kong a new type of reusable fabric mask, CuMask+, will be issued to all citizens. This patented six-layer mask is washable 60 times and incorporates copper as a key filtering component, although there is some dispute over the extent of claims of efficacy.

What of mask deniers? I am afraid that they are still out there. The inconvenience of wearing a mask is tiny for most of us. Those who lipread for whatever reason need to see a person’s mouth and a very small number of people cannot tolerate a mask, so exceptions are appropriate. For the rest of us, it is only a slightly increased effort to breathe through the mask and cope with fogged-up glasses—although proper eye protection is associated with less infection. However, we all have a duty to others—the ethical principles of justice and that we do not cause harm. We have no idea if the person that we passed in the shop, the street or elsewhere is in a high-risk group and should be shielding.

Thin, disposable masks are not adequately protective, and there are now more masks than jellyfish in some seas. It is predicted that 75% of throwaway masks will end up in landfill or in oceans. The ecological effect will be long-lasting, as these masks last 450 years before degrading. What is the Government’s policy to radically decrease mask litter? Why are we not providing advice on how to recycle masks—for example, by hot-ironing cloth ones?

I stress, as I have before and as Distance Aware aims to stress, that the most important measures are social distancing and hand washing. Is the word “space” used simply because it rhymes with “face”? Is there evidence that the public know that this means the two-metre rule? Will the Government make it crystal clear that the two-metre distancing rule is more important than anything else, and that masks can be an adjunct of that but no substitute for it? Other than fines, what is being done to empower those who deserve to be protected when confronted by someone who is simply too selfish to wear a mask properly and thinks it is funny to hang it around their chin or off one ear? I hope we are at the end of mixed messages and that social duty towards each other will define what we do.

Covid-19: Local Restrictions

Baroness Finlay of Llandaff Excerpts

Friday 9th October 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I completely recognise the importance of stakeholder engagement, building alliances and collaboration. I emphasise our commitment to the partnership between local and national government. When it comes to Parliament’s engagement in these measures, I can only repeat what I said earlier: my right honourable friend has made it very clear that for significant national measures with effect in the whole of England or UK-wide, we will consult Parliament and, wherever possible, hold votes before such regulations come into force. Until then, it is through the usual channels that the schedule of the House of Lords will be arranged.

[Baroness Finlay of Llandaff (CB)]

Building on the Minister’s commitment to locally led decision-making, will the Government confirm that they will now consult daily with the devolved Administrations and share evidence prior to any press release, as confused messages have undermined public confidence? That way, they may avoid some of the debacles that have happened when local authority decisions have been undermined by leaks to the press.

[Lord Bethell (Con)]

I completely defer to the noble Baroness’s expertise in matters to do with the devolved Administrations, but I reassure her that there are numerous calls every day between Whitehall and the DAs on Covid. We very much celebrate the achievement of a four-nations approach. There are divergences in some procedural matters between the different countries; that is entirely to be expected—indeed, celebrated—as it enhances the effectiveness of our measures. But I completely take on board the noble Baroness’s points and we will endeavour to ensure that communication between Whitehall and the DAs remains firm and solid.