Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) (No. 2) Regulations 2020
Baroness Finlay of Llandaff Excerpts(5 years, 1 month ago)
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Baroness Finlay of Llandaff (CB) [V]
Dame Deirdre Hine’s report on the 2009 influenza pandemic recommended raising public awareness and understanding about the key characteristics of a pandemic and core response measures. Yet we learned little. A failure of public communication through excessively optimistic mixed messages has led to deepening distrust. Some reporters, such as Fergus Walsh, have explained the scientific and clinical reality well, but we need clear, consistent messaging across the UK, sharing uncertainty and true risk. For example, the B.1.1.7 variant infectivity in effect adds more than 0.4 to the R number. The current reality is proving even worse than the modelling predictions for the coming months for bed shortages, overloaded services, staff infections and exhaustion. Second-time infections are now presenting, as antibodies seem to be short-lived.
Yes, the vaccine is brilliant news; it should prevent fatal infection. But infection control measures will remain essential in the long term. We do not know how long the immunity will last, whether those immunised will still get infected and be viral carriers and spreaders, nor how rapidly further mutations will develop, leading to the need for new modifications and new vaccines. Will the Government collate immunisation data from the NHS number with diagnostic data in the long term to understand the epidemiology as it evolves? Mixed messages and false hope fuel mistrust. Control will only be achieved by collaboration with the public when they understand that vaccination is not a quick fix.
Care Quality Commission Report
Baroness Finlay of Llandaff Excerpts(5 years, 2 months ago)
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Lord Bethell (Con) [V]
My Lords, my noble friend makes an extremely important point. The role of families and communities in the social care provided to those with autism and learning difficulties is extremely important and will be at the centre of every recommendation that we make in response to this report.
Baroness Finlay of Llandaff (CB) [V]
I declare my role as chair of the National Mental Capacity Forum. Are the Government considering the separation of learning disabilities from within the Mental Health Act to drive training in early crisis recognition and de-escalation in the community, learn from good practice and pilot alternative ways of providing places of safety in a crisis? The underlying social problems need social care solutions and are not always appropriate for, or amenable to, medical intervention.
Lord Bethell (Con) [V]
The noble Baroness makes her point extremely well. These are exactly the kinds of questions that have been considered by Sir Simon Wessely’s review of the Act. As I said earlier, we are looking forward to publishing a White Paper on the Mental Health Act 1983 shortly, and those are exactly the kinds of issues that it will seek to address.
Covid-19 Update
Baroness Finlay of Llandaff Excerpts(5 years, 2 months ago)
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Baroness Finlay of Llandaff (CB) [V]
My Lords, I declare that I chair the National Mental Capacity Forum. I ask the Minister to express thanks to staff in his department as they continue to work with us and the Ministry of Justice to run a rapid-response webinar on Friday, requested from primary care leads yesterday, following their pilot, to support primary care as vaccination is rolled out to care homes, where many residents have seriously impaired capacity. We aim to disseminate the latest guidance and ensure appropriate information to support understanding for consent to vaccination, including easy-read and pictorial versions of information.
Lord Bethell (Con) [V]
I am enormously grateful for the work that the noble Baroness, Lady Finlay, and the National Mental Capacity Forum have done during the pandemic. The issue of mental capacity and consent has been addressed in official guidance that the NHS and others have issued to medical professionals who will administer the Covid vaccine in care homes. I understand that officials at the DHSE and the MoJ are supporting the forum with the webinar planned for this Friday, and I am absolutely delighted to reaffirm the Government’s support for the forum’s work on these important areas.
Covid-19 Update
Baroness Finlay of Llandaff Excerpts(5 years, 2 months ago)
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Lord Bethell (Con)
I welcome my noble friend’s challenge. I reassure him that the testing and vaccination programmes will absolutely run alongside each other and that this has already been happening. They are collaborating very closely. The resources being provided for both are generous enough to ensure full delivery of the vaccine. The rollout of the community testing programme is a sign of the success of test and trace, but it will in no way have a negative impact on the deployment of the vaccine programme, which remains a number one priority for the Government.
Baroness Finlay of Llandaff (CB) [V]
My Lords, given that some people need to go to visit a relative who is dying or otherwise very distressed, will the Government instigate a system whereby these people can register that they will need to travel across boundaries? They may even need to stay over to provide care for some time, to enable a person to be cared for in their own home. Under the current situation, they risk being given a criminal record for breaching rules, and then they may have to try to defend themselves in retrospect after the person has died.
Lord Bethell (Con)
I thank the noble Baroness for her characteristically compassionate question. I can reassure her that there are exceptions for essential travel. The kind of scenarios that she just described would seem to me to fit into the definition of exceptional travel. I am happy to look into whether some form of registration process is necessary but, as far as I understand, that has not proved to be the case.
Covid-19: Vaccination Prioritisation
Baroness Finlay of Llandaff Excerpts(5 years, 2 months ago)
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Lord Bethell (Con)
My noble friend has made the case for rough sleepers extremely well. It is one that we are deeply concerned about. When it comes to the prioritisation list, what has been published so far is an interim and indicative list. It will be reviewed, and a more detailed list will be published in time.
Baroness Finlay of Llandaff (CB) [V]
As the Government keep the priority list under review, will they also look at the results of the New York vaccine rollout prioritisation? Younger adults who have been shielding are often already on a list, are at high risk and have children at school or college who are also their carers. These children are already stressed, if they attend education, knowing that they risk being asymptomatic virus carriers into the home and that Covid could kill their parent or sibling.
Lord Bethell (Con)
I am extremely grateful to the noble Baroness for suggesting the New York precedent. It is not one that I was aware of and I will look into it. I reassure her that we are liaising with all our international partners over the vaccine rollout to ensure that we put in the best possible practice that we can.
Medicines and Medical Devices Bill
Baroness Finlay of Llandaff ExcerptsTuesday 17th November 2020
(5 years, 2 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-VII(Rev) Revised seventh marshalled list for Grand Committee - (17 Nov 2020)
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.
Baroness Finlay of Llandaff (CB) [V]
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
“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.
Lord Ribeiro (Con) [V]
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.
The Deputy Chairman of Committees (Lord Duncan of Springbank) (Con)
I thank the noble Baroness, Lady Cumberlege—that is very gracious. On that basis, we have nobody else to come in after the Minister at this point so I come directly to the noble Baroness, Lady Finlay of Llandaff.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I thank all noble Lords who not only spoke in support of the amendments in this group but expanded on them and provided additional information.
I understand the Minister saying that it is important to get this right and not rush, and that the consultation will inform the SIs. I also understand him pointing out the rigidity of primary legislation. I accept his points and am glad for the assurances he was able to give.
I stress the importance of looking at all implantable devices, even those that look as though they are in such common use that we do not need to worry about them. An example happened just a couple of weeks ago when a guide wire for a pacemaker snapped inside a patient. Completely unknown previously, these things can happen. They need to be picked up and recorded.
We also need to update the way in which we record information and use the new artificial intelligence computer systems to analyse it. The reason I asked for expert oversight is that there is no point in putting information into any kind of database unless the right information is extracted from it, and expertise is needed to set that up. I accept, however, that this is a hub, not a decision tool in itself.
The yellow card system that the Minister spoke about needs to be publicised much more widely. I hope that, as we go forward, there will be a positive move across the whole of healthcare, in particular to make sure that patients are aware of this scheme so that they can use it appropriately and early. It is an amazing scheme; I pay tribute to Professor Phil Routledge, who instigated it many years ago—decades ago, I think—as a way of collecting adverse reactions.
I appreciate the Minister’s assurance about working with the devolved nations, particularly in the light of the unfortunate remarks made recently about devolution. It is important to have compatible information systems and oversight that allows the free movement of information. That happens in the UK Foundation Programme Office and the UK medical and dental recruitment offices, where four-nation oversight works well. I know that those types of medical practice are outside the Bill’s remit but we have examples of good working, which needs to be built on to cement the sharing of information across the different healthcare systems.
With that and with all the points made, which I hope will thoroughly inform the statutory instruments as they are developed, I beg leave to withdraw the amendment.
Medicines and Medical Devices Bill
Baroness Finlay of Llandaff ExcerptsWednesday 11th November 2020
(5 years, 3 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-V Fifth marshalled list for Grand Committee - (6 Nov 2020)
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.
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.
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.
“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.
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.
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(5 years, 3 months ago)
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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.
Covid-19: Contracts and Mass Testing Programme
Baroness Finlay of Llandaff Excerpts(5 years, 3 months ago)
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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 ExcerptsWednesday 4th November 2020
(5 years, 3 months ago)
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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.