Medicines and Medical Devices Bill

Baroness Finlay of Llandaff Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

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

My Lords, I declare that I am vice chair of the NICE review committee. Amendment 66, moved by the noble Lord, Lord Hunt of Kings Heath, aims to ensure early access for NHS patients to medicines and medical devices. This must also involve ensuring that results of safety and efficacy from devices in real-time use—as well as in trials—are registered, published and then considered again in real time, a process that I hope will be helped and promoted by the patient safety commissioner role.

Noble Lords will remember that in Committee I tabled, along with the noble Lord, Lord Hunt of Kings Heath, an amendment to ensure provision for the development of a new rapid provisional two-year licensing procedure. The intention behind that amendment was to ensure that patients could more quickly access potentially life-saving medicines and medical devices.

I sincerely thank the Minister and his team for meeting with me on this, and for the other meetings they facilitated. I am reassured that the approval processes from the MHRA over device development are due to be revised completely over the coming year, with improved and streamlined processes, and I hope that today the Minister can confirm this, even with a timeframe, so that we can move forward quickly.

We have a unique opportunity to develop devices and roll them out to the NHS, but it is important that approval processes do not slow down or block patient access to improvements in treatment and management over a wide range of conditions, particularly rare disorders. Evidence from real-time use is crucial, and development and improvement can become a virtuous circle when that is rapidly fed back—so we become the intellectual innovation hothouse for our future prosperity, while also benefiting our patients. The UK can then be seen as a favourable place to develop, approve and supply medicines and medical devices.

Speeding up and widening approval processes, including two-year provisional licensing that I have been advocating with the Royal College of Physicians, would ensure that developing a new device from beginning to end—taking an idea from conception to supply—all in the UK is seen as an attractive prospect. Otherwise, we continue to risk new devices beginning their innovation journey in the UK, then being taken abroad part-way through the development process and marketed back to the UK. Keeping the entire process in the UK, with different models of fast-track approvals and provisional approvals, will allow better oversight of the safety and efficacy of devices during early access, with ongoing monitoring in real-time use. That would then facilitate moving into appropriately costed long-term approval processes.

We can innovate in the UK and stop intellectual capacity being outsourced. We can protect the safety of patients while getting them access to the latest treatments. It is patients who will suffer if we do not get this right, which is why the proposals in this amendment are so important.

Covid-19: Variant

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Wednesday 13th January 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, PHE weekly seroprevalence data suggests that antibody prevalence among blood donors aged 16-plus in England is 6.9%, which is consistent with other data that we have. The MHRA has considered this and has decided that vaccinating is just as important for those who have had Covid-19 as it is for those who have not.

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

How are demographic and NHS outcome data and test results from patients across the UK being collated to identify patterns suggesting further new variants, reinfections, changes in risk factors to severe disease, such as malnutrition, and planning for managing long Covid and modelling ICU provision?

[Lord Bethell (Con)]

The noble Baroness alludes to a world of analytical complexity, which is very much what we have to look forward to. The way in which this new variant has popped up and has been dramatically more transmissible presents a wholly different level of threat compared with the one that we were dealing with just six weeks ago. It is a matter of grave concern to all of us that this mutation has happened. However, I reassure noble Lords that we have very strong genomic capability in this country. Roughly 5% of all tests are analysed. It is only 5% but that is more than in most other countries, and we are putting in the analytical muscle to be able to process that data.

Medicines and Medical Devices Bill

Baroness Finlay of Llandaff Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

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

My Lords, I, too, welcome the Government’s amendment establishing the patient safety commissioner. This is highly significant and a great tribute to the noble Baroness, Lady Cumberlege, and her team. I should also declare an interest I must declare an interest as a member of the GMC board.

The noble Baroness’s report, First Do No Harm, is a stark and moving account of how thousands of patients were let down in a serious and life-changing way. I go back to her report because she found that the healthcare system, in which she included the NHS, private providers, regulators, professional bodies, and pharmaceutical and device manufacturers, was disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’être. Those are telling points, which led the noble Baroness to recommend the appointment of a patient safety commissioner, an independent and proactive public leader with a statutory responsibility to champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety. That is welcome and it will be essential that the person who is appointed is robust, fearless and commands wide respect. Their independence needs to be assured. I hope also that the appointment will be subject to Select Committee scrutiny and I should be glad if the Minister can comment on that.

Picking up on a point that the noble Baroness made, I should also be grateful if I could have a little more explanation about what is meant by relevant bodies, as defined in the schedule. It is clearly important that bodies with responsibilities in relation to patient safety are expected to respond to a report or recommendation made by the commissioner. Can the Minister give a broad indication of the relevant bodies? Also, in relation to the private health sector, my reading is that this is covered by the Bill and that the schedule provides for that. Can the Minister respond?

Overall, however, I commend the Minister on the Government’s response to this significant recommendation by the noble Baroness, Lady Cumberlege.

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

My Lords, these amendments are a testament to the incredibly hard work and perseverance of the noble Baroness, Lady Cumberlege, the Minister and the noble Baroness, Lady Penn. They have all worked hard to get to this point. The report, First Do No Harm, must be a turning point in driving up better outcomes.

I hope that in the response to these proposals it will be helpful to have reassurance that the new post will be adequately resourced, the timeframe for fulfilling the appointment is rapid, and, subsequently, regulatory requirements can be defined and relevant statutory instruments drawn up. The independence of the post-holder is crucial. The person must be able to work across all the different and varied organisations and structures that have responsibility for patients, directly or indirectly. That will require promotion to all organisations that they have a duty to co-operate and collaborate with the commissioner to ensure that early warning signals are picked up and heeded through processes that are light on bureaucracy yet rapidly responsive in order to pick up signals. We cannot have years of accumulation of distressed patients. When things start not to be right, those amber warning lights must start flashing.

I urge the Minister to ensure that the remit of the commissioner is as wide as possible. For example, the coroners’ reports that the noble Baroness, Lady Cumberlege, referred to have not had adequate enforcement by others sometimes. The reports made powerful recommendations but it was found that those responsible for enforcing them have been so slow to act that the proposals have effectively gathered dust.

In previous debates, I raised the need for the yellow card scheme to be updated—opened for easy use by patients themselves, who may wish to report adverse outcomes. The wording of the Bill that I found most helpful and welcome is the part stating that the role

“does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue”.

Can the Minister make sure that the reporting mechanisms are open to patients and do not hit a hurdle when they try to report to a clinician who does not recognise the full import of they are saying?

To conclude, I reiterate my congratulations to all, particularly the noble Baroness, Lady Cumberlege, and her team, and look forward to the next phase of working with her and others as this important development moves forwards.

[Lord O'Shaughnessy (Con)]

My Lords, I join other noble Lords in expressing my sincere thanks to my noble friend the Minister for the progress that we have made. In all fairness to him, he said that since Second Reading he was listening, but we all know that it is sometimes possible to listen and not hear, let alone act. On this occasion, he heard and acted. I join other noble Lords in expressing my sincere gratitude for that.

I also pay tribute to my noble friend Lady Cumberlege. No one doubted her tenacity but it has been on display in bucketloads, and she has made the progress that her superb report deserves. More than anyone, I pay thanks to the army of campaigners; many of us have met them, and they could not help but move us with their stories. This legislation is ultimately for them and a tribute to them.

I had a close look at my noble friend the Minister’s amendment and compared it to that of my noble friend Lady Cumberlege. Clearly, there is a specific issue about where the organisation, the commissioner, should sit, but there is a precedent for doing that in the way in which the Minister suggested. I take confidence from his determination to give proper independence to the role. A lot will depend on the kind of person recruited, how they are recruited and to whom they are accountable. I should like him to say a little more about how he envisages that happening.

We also need to hear more detail on the timetable. The Minister will know that when one makes big commitments of this kind, they are staging posts—never the destination. There is still some way to go in making sure that we get there quickly. That is important, as my noble friend pointed out. However, the powers in the amendment are important to recognise. On the ability to demand information from relevant persons, as other noble Lords have said, we need to hear a little more about who they are and the consequences of non-compliance. However, they are powerful ways in which the commissioner can act and create change in the system. I have no doubt that they will be effective.

In conclusion, I make a couple of comments provided by the ABPI’s briefing. They relate to further questions around the nature of the relationship between the commissioner and the MHRA and other bodies, how the four nations of the UK will act together on patient safety, given that we are a single market, and ensuring diversity of patient voice.

I would also add one more thing to that. Patient safety is not just about finding out when medicines and devices go wrong; it is also about access to them. Will the patient commissioner have a remit to investigate these kinds of issues?

However, these questions are for tomorrow. Today, we want to recognise the progress that has been made and the amendments put down in the name of my noble friend. I thank him sincerely for them and I thank my noble friend Lady Cumberlege for her dedication to this particular cause.

--- Later in debate ---

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

My Lords, it is a great pleasure to follow the noble Lord, Lord Hunt of Kings Heath, on this very important amendment. It is an example of how, with high moral standards, the Ministers involved have been listening. With others, I wish to sincerely thank the noble Lords, Lord Bethell and Lord Ahmad of Wimbledon, and the noble Baroness, Lady Penn, who have listened to very difficult information and accepted the important responsibility we have on the world stage.

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

Baroness Finlay of Llandaff Excerpts

Thursday 7th January 2021 Lords Chamber

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

Today, Health Service Journal published:

“Hospitals, particularly in London and the surrounding areas, are seeing very high and rapidly growing numbers of covid-19 admissions, and are running out of options to free up beds.”


Discharge of patients to care homes has become increasingly difficult, despite beds in many care homes lying empty, as care providers fear repeating the disaster of the spring in the sector, and they are not insured to become Covid-designated homes. Will the Government provide rapid short-term indemnity, such as is provided for the NHS?

Ysbyty’r Seren in Bridgend is the busiest field hospital, operating since mid-October as a step-down unit. Today it has 72 patients. Wales has been about two weeks ahead in this second wave and important virological evidence is emerging. Is experience being sought from Wales for the Nightingale hospitals and is data from all aspects of the pandemic, including genomic testing, being rapidly shared?

Lockdowns have seen a drop in other respiratory infections, such as respiratory syncytial virus, yet sceptics are doing untold damage, endangering the lives of many, including clinical staff who are now exhausted, burnt out, seriously ill with Covid or having to isolate. As the Minister said, the new variant is highly infectious, yet many workplaces, such as factories, food processing plants and schools have remained open without any ventilation system guidance. Will the Government urgently learn from Germany and instigate ventilation guidance, support and certification of ventilation systems, establishing a rapid national standard for machines that lower viral count in the ambient air?

Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) (No. 2) Regulations 2020

Baroness Finlay of Llandaff Excerpts

Wednesday 30th December 2020 Lords Chamber

[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.

Covid-19 Update

Baroness Finlay of Llandaff Excerpts

Tuesday 15th December 2020 Lords Chamber

[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.

Care Quality Commission Report

Baroness Finlay of Llandaff Excerpts

Tuesday 15th December 2020 Lords Chamber

[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

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Monday 30th November 2020 Lords Chamber

[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

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Wednesday 25th November 2020 Lords Chamber

[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 Excerpts

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

Moved by

[Baroness Finlay of Llandaff]

95: Clause 16, page 9, line 18, leave out “may” and insert “must”
Member’s explanatory statement
This amendment is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill, setting up the new information system envisaged by Clause 16.

[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.

--- Later in debate ---

[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.

Amendment 95 withdrawn.