38 Lord Clement-Jones debates involving the Department of Health and Social Care

Thu 12th Feb 2026
Wed 4th Feb 2026
Medical Training (Prioritisation) Bill
Lords Chamber

2nd reading & 2nd reading: Minutes of Proceedings & Committee stage
Tue 5th Apr 2022
Health and Care Bill
Lords Chamber

Consideration of Commons amendments & Consideration of Commons amendments
Thu 3rd Mar 2022
Health and Care Bill
Lords Chamber

Lords Hansard - Part 1 & Report stage: Part 1
Wed 26th Jan 2022
Health and Care Bill
Lords Chamber

Lords Hansard - Part 1 & Committee stage: Part 1
Thu 14th Jan 2021
Medicines and Medical Devices Bill
Lords Chamber

Report stage:Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Tue 12th Jan 2021
Medicines and Medical Devices Bill
Lords Chamber

Report stage & Report stage:Report: 1st sitting & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Wed 11th Nov 2020
Medicines and Medical Devices Bill
Grand Committee

Committee stage:Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords

Medical Training (Prioritisation) Bill

Lord Clement-Jones Excerpts
Lord Darzi of Denham Portrait Lord Darzi of Denham (Non-Afl)
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My Lords, many of you will know that I did my medical training in Ireland. In fact, I exercised some of my skills in this Chamber back in 2007. Irish medical education is excellent, and many of its graduates have gone on to distinguished careers in the NHS. I speak today to ensure we strike the right balance in this Bill, specifically by securing fair treatment for doctors who hold degrees approved by the Irish Medical Council.

As drafted, the Bill would exclude graduates of the Royal College of Surgeons in Ireland at its medical campus in Bahrain, for example—a campus that was established more than 20 years ago. Let me be clear about what that institution delivers: it has the same curriculum, the same examinations and the same quality assurance as Dublin, leading to a single national University of Ireland degree. Its programme and clinical training sites are also accredited under Irish regulatory oversight by the Irish Medical Council. I urge that, on Report, wording be introduced to bring graduates of this institution within the priority group. Such a clarification would sit squarely alongside the amendments from the noble Baroness, Lady Gerada, and the noble Lords, Lord Clement-Jones and Lord Mendelsohn. These seek to ensure that medical graduates of a UK university holding a GMC-approved degree and following the same curriculum and assessment, but studying outside the British Isles, are included in the priority group. It would also be consistent with the similar amendment tabled by the noble Lords, Lord Forbes and Lord Shipley, and the noble Baronesses, Lady Finlay and Lady Hollins.

I draw a further anomaly to your Lordships’ attention. The unamended Bill would place graduates of the Royal College of Surgeons in Ireland’s campus in Penang, Malaysia—a joint programme with University College Dublin—within this priority group. These students study an Irish Medical Council-accredited, GMC-recognised degree, completing half their education in Ireland and half in Malaysia. Yet the well-intentioned clarifying amendment of the noble Baroness, Lady Finlay, requiring at least 60% of the time to be spent in Ireland, would inadvertently exclude them.

Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, it has been many years since I last spoke in a health debate. There is a sense of déjà vu in seeing the noble Earl, Lord Howe, on the Opposition Front Bench. It is also an absolute pleasure to hear from the noble Lord, Lord Darzi, and to hear the arguments he has made, which are very consistent with those we will be making later in the group of amendments from the noble Baroness, Lady Gerada.

I rise to speak to the amendments in this group, but particularly to Amendment 2, in the name of the noble Baroness, Lady Coffey, and the amendments tabled by the noble Lord, Lord Patel. On Amendment 2, while I understand the intent of the noble Baroness to protect the domestic workforce, we on these Benches cannot support the introduction of citizenship as a primary filter for medical training priority. To do so would undermine the central logic of this Bill, which is to protect the taxpayers’ investment in training, not to police the passport of the trainee. If a non-UK citizen comes to this country, trains in our medical school for five years, often paying significant international fees—my noble friend made an extremely good point about the value of that to our universities—they cross-subsidise our universities and then commit to the NHS. They are a UK medical graduate in every sense that matters to workforce planning. Their training is identical; their clinical exposure is identical. We on these Benches believe that to deprioritise them, based purely on nationality, would send a disastrous signal to the global talent pool that our NHS has always relied upon. It would also contradict the argument we will make later regarding the amendments from the noble Baroness, Lady Gerada, on the Queen Mary University of London Malta Campus: that it is the content and quality of the qualification that matters, not the geography or the nationality.

Regarding the amendments in the name of the noble Lord, Lord Patel, I sympathise with his desire to ensure that UK graduates are prioritised. That is, after all, the purpose of the Bill, and while we can argue about the definition of a UK graduate, we must be careful not to make the legislation so rigid that it removes any flexibility for the Secretary of State to address shortages in specific specialties, or where international talent is essential. Several noble Lords have mentioned that we have all received correspondence from doctors in hard-to-fill areas who warn that absolute exclusion could leave rotas empty. Prioritisation must not constitute a blockade.

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Baroness Finlay of Llandaff Portrait Baroness Finlay of Llandaff (CB)
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My Lords, I declare my role as a pro-chancellor of Cardiff University, and that I have until recently been an observer on the Medical Schools Council; I am still in touch with it.

This group of amendments seems incredibly important for our international reputation for fairness and consistency in what we commit to, but also in wanting excellence in our NHS. Therefore, there needs to be a sophisticated way of prioritising. One of those important areas is the contribution to the NHS, especially during Covid and major events, when some have gone way above what is normally expected and come back from holiday or maternity leave, or whatever, to deal with a major incident, while others have perhaps not always been quite so flexible.

We certainly have a crisis and must deal with it, so this is not in any way to say that we should not be doing this, but the timing is the worry. I will come on to the other degrees in the next group. Can the Minister explain whether the Oriel system itself is a block to incorporating the flexibility that these amendments ask for? There is a real worry among some that the Oriel system is a rate-limiting step, rather than being flexible enough to be rapidly reprogrammed appropriately to allow the intention of these amendments to be incorporated at great speed, and therefore redress the accusation of unfairness.

Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, I offer our strong support for Amendments 9, 11, 24 and 25 in the name of the noble Lord, Lord Stevens of Birmingham, and Amendments 5 and 10 in the name of my noble friend Lord Mohammed. I thank the noble Earl, Lord Howe, for his Amendment 4, because it, in essence, sets the theme of this group, which is the dashing of legitimate interests for this year, which a number of noble Lords explored.

Before I address the specific mechanics of these amendments, we need to thank the noble Lord, Lord Stevens, and other noble Lords who highlighted at Second Reading the whole question of the protracted failure in long-term workforce planning. For years, we have seen a disconnect between the number of medical school places and the number of specialty training posts. There is a bottleneck of our own making: 12 applications for one post is a disaster. My late wife trained in the 1970s and became a registrar at Barts. I have no recollection of it being anything like on this scale, and we risk dashing the expectations of many of those currently in training.

As the noble Lord, Lord Stevens, noted at Second Reading, the Bill does not widen the bottleneck; it simply reshuffles the queue. Although we on these Benches accept the principle that UK graduates should not face unemployment after taxpayer investment, we must ensure that, in correcting one failure, we do not commit a second failure of fairness against those have served our NHS in good faith.

These amendments address one of the greatest injustices in this Bill: the decision to implement major changes mid-cycle for 2026, using the blunt instrument of indefinite leave to remain as a proxy for experience. The Government claim that assessing actual NHS experience is “not operationally feasible” for the 2026 rounds. Since Second Reading, we have received compelling evidence to the contrary. As my noble friend says, we have heard from doctors currently using the system who confirm that the Oriel recruitment platform already captures data on “months of NHS experience”. The question is there; the data exists. The claim that this cannot be done is a choice, not an administrative necessity.

By refusing to use this data, Clause 2 creates a perverse experience gap. It excludes doctors who have served on our NHS front lines for two or three years but who have not yet reached the five-year threshold for settlement. We have received hundreds of emails detailing the human cost of this decision. We heard from a mother who lived apart from her one year-old child for seven months to study the MSRA exam, only to find the rules changing days after she sat it. We heard from a neurosurgery SHO with two years of NHS service, who notes that this mid-cycle change renders his sunk costs unrecoverable. We have heard from a British citizen whose wife, a doctor on a spousal visa, is deprioritised, despite being a permanent resident.

Amendments 9 and 11 offer the Government a lifeline. They are permissive—my noble friend’s amendments mandate the Government. The bottom line is that the Secretary of State should use the data we know Oriel possesses to prioritise those with significant NHS experience in 2026, just as they intend to do in 2027. To reject this is to choose administrative convenience over natural justice.

I see the amendments at this stage as a probing opportunity. We need the Minister to explain in specific, technical detail why the existing Oriel data fields regarding employment history cannot be used to filter applicants for this cycle. If the Minister cannot provide a satisfactory technical explanation today, and if the Government resist this flexible approach, we will be forced to conclude that this is a choice, not a necessity. In that event, we may well need to return to it on Report.

Baroness Merron Portrait Baroness Merron (Lab)
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This group of amendments relates to the implementation of prioritisation of posts starting in 2026. I thank all noble Lords for their consideration of this. It is a very important area, as noble Lords have said, and I have listened closely, as ever, to the points made.

Beginning with prioritisation for the UK foundation programme, Amendment 4, tabled by the noble Earl, Lord Howe, seeks to prevent prioritisation applying to offers for the foundation programme that were confirmed before 13 January. To clarify, the Bill will impact only offers for places made after the Bill is passed and becomes law. The Bill will therefore not have any impact on offers to the foundation programme made before it becomes law. In our view, the amendment is therefore not necessary. In any event, no such offers exist, other than for a very small and specific group.

The noble Lord, Lord Stevens, asked about those who have already been allocated. The only individuals who have already been allocated foundation programme places for 2026 are those who deferred last year for statutory reasons, such as maternity leave or sickness absence. These individuals have already been assigned to posts, and this year’s allocation process does not affect them in any way.

On a more general point, as I referred to in the earlier group, and as noble Lords will recall, the 10-year plan, which was published in July 2025, confirmed that it was the intention of the Government to come forward with the Bill we are speaking of today. The noble Lord, Lord Stevens, asked about the time it has taken since that date in July 2025. I can only say to the noble Lord that this is linked to our careful listening, which he will be aware of, to resident doctors and our understanding of the pressures that they are facing. The Bill is about action now. It is about acting decisively and introducing legislation for 2026, because, as noble Lords have kindly acknowledged, we need to start reshaping the workforce pipeline and show our commitment to easing the bottlenecks in training places.

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It is worth acknowledging that a number of people have written to noble Lords, including to me, very much in support of the Bill and have urged us in our considerations to look at passing this in an unamended form. It is important to acknowledge their voices too.
Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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I would be grateful if the Minister could say what proportion of those who wrote were disappointed with the Bill versus those who wrote supporting it.

Baroness Merron Portrait Baroness Merron (Lab)
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I cannot give an exact proportion, as the noble Lord is aware, but I have noticed that the proportion has changed as the Bill has progressed. As we have approached Committee, I have certainly seen more email traffic urging a non-amended Bill rather than an amended Bill. I would imagine that that is reflected in other emails. The noble Lord is indicating that it is not. I can see differing responses, but that has certainly been my impression.

The application of prioritisation to the 2026 intake is necessary and justified. If, as I referred to earlier, we waited until 2027, competition ratios are projected to rise even further, meaning that more UK graduates would be unable to progress their careers on time, with a greater risk to the long-term sustainability of the workforce. For these reasons, another year’s delay is not an option, and we cannot accept the noble Lord’s amendment.

Amendment 10, also tabled by the noble Lord, Lord Mohammed, also seeks to change categories of people who would be prioritised for specialty training places, starting in 2026, by virtue of having significant NHS experience or by reference to their immigration status. We cannot accept this amendment on the basis that the effect would be to prioritise every individual who applied for specialty training places in 2026 because all applicants are, by necessity, already registered on Oriel. This amendment would in practice nullify prioritisation for 2026 and render the legislation ineffective. It would not address the severe and growing bottlenecks in specialty training that the Bill aims and is designed to tackle.

The proposal to prioritise those who have demonstrated a professional commitment to the NHS also presents workability problems as there is no clear or objective definition of what such a commitment looks like, nor any reliable way to assess it for tens of thousands of applicants at this stage. Attempting to do so would be unmanageable in a practical sense and would introduce inconsistency, delay and uncertainty for applicants.

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Baroness Merron Portrait Baroness Merron (Lab)
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Although I cannot be specific about what is technically possible, I can say that, as the noble Lord is aware, the arrangements for 2026 in the Bill can change for 2027, and that will be the subject of consultation with a wide range of stakeholders to get the best definitions we can. We know that currently, because of the time pressure, we are going to have to use—I think the noble Lord used the word “proxy”, in my view correctly. So that is where we are.

Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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The Minister criticised Amendment 10 from my noble friend on the basis that, in a sense, it is technically not doing what it attempts to do. But she has not really addressed the key argument at the core of this, which is that the Oriel system is capable of assessing precisely the kinds of two-year experience that so many of these deprioritised doctors will have. Is the Minister saying that it is absolutely not possible to use the Oriel system for that purpose in this context?

Baroness Merron Portrait Baroness Merron (Lab)
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My recollection from my discussion with officials about this very point is that, with no criticism of the Oriel system, this is about what we are trying to do now and what we have available to us. It would require—I am looking for the right words—not just using that system but manual attention to thousands of applications. I am very happy to write to the noble Lord with further technical advice on the matter, but that is the situation of which I have been advised. The whole point about the way the Bill is designed is to make it workable. If we change it, we know we cannot deliver in the way the noble Lord might wish.

Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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I thank the Minister for that. I hope that, despite the recess, there will be time to get all the information we need. There is a real problem here with the credibility of the Government’s position. There are many of us who hope that it will be possible to do something different, particularly since, in a way, the boot is on the other foot. The Government have had since last July, as we keep being told, to get the Oriel system fit for purpose in order to supply the information for 2026.

Baroness Merron Portrait Baroness Merron (Lab)
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The noble Lord is ambitious on workability, beyond what I can honestly confirm is possible. Noble Lords would not wish me to stand at the Dispatch Box and suggest that, having looked at all we could do, the situation is anything other than that this Bill is a workable option. I can assure him that, as always, all noble Lords will get the information they are promised in a timely fashion. I also hope that the all-Peers letter and the letters I subsequently sent in respect of various areas of concern were helpful to noble Lords. I will of course ensure that anything further is there.

The issue with Amendment 10 is also that there is not that clear objective and definition of what a commitment looks like; it makes reference to it but does not explain it. By contrast, the Bill uses a set of carefully chosen, specified immigration statuses as a practical and proportionate proxy for identifying applicants who are most likely to have an established professional commitment to the NHS, which I believe is what all noble Lords are looking for. After careful consideration, we have concluded that for the 2026 recruitment round, that is the best approach. The amendment would remove any practical effect of prioritisation, which of course is at the heart of the Bill.

Amendments 9, 11, 24 and 25, tabled by the noble Lord, Lord Stevens, seek to create a regulation-making power to define additional persons with significant NHS experience to be prioritised for specialty training in 2026. We cannot accept these amendments. As already stated, the Bill sets out the most suitable criteria for prioritising specialty training places in this year. Under the existing Clause 2(2), for specialty training places starting in 2026, immigration status will be used as a practical proxy for NHS experience to allow prioritisation to begin swiftly. This proxy is being used because applications for posts starting in 2026 have already been made. Therefore, we need to prioritise based on the information already captured, and which can be assessed.

To build on what I was referring to in the exchange with the noble Lord, Lord Clement-Jones—I know this is also of interest to the noble Baroness, Lady Finlay—while NHS experience is captured in the Oriel recruitment system, using it as an assessment criteria for the 2026 allocation round would require a manual review of tens of thousands of applications, “manual review” being the words I was looking for earlier. This is just not operationally feasible. There is no current agreed threshold for what constitutes a meaningful level of NHS experience. Stakeholders offer very different views on this, which is why we have committed to a proper engagement process, subject to the Bill’s passage, to ensure that any future definition is fair, evidence-based and deliverable.

The Bill already gives us flexibility to ensure that we take the best approach to prioritising those with NHS experience for specialty training posts in subsequent years. For posts starting in 2017 onwards, the immigration status category will not apply automatically. Instead, we will be able to make regulations to specify any additional groups who will be prioritised by reference to criteria indicating significant experience as a doctor in the health service, or by reference to immigration status.

For the reasons I have outlined, I ask noble Lords to withdraw or not press their amendments.

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Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, I strongly support Amendments 15, 16 and 19, tabled by the noble Baroness, Lady Gerada, which I have signed, and which she spoke to so convincingly. These Benches also support Amendment 17 in the name of the noble Lord, Lord Forbes, and signed by my noble friend Lord Shipley, and Amendment 20 in the name of the noble Earl, Lord Howe.

As I said at Second Reading, I am the former chair of the council of Queen Mary University of London and now, for my sins, an honorary professor. Amendments 15, 16 and 19 seek to correct a category error in the Bill: namely, the classification of students holding a UK primary medical qualification from a UK public university as “international”, solely because their classroom is in Malta. I am sure the noble Lord, Lord Forbes, will say the same in respect of Malaysia. The Minister has argued that these students lack “clinical familiarity” with the NHS, but that does not withstand scrutiny. These students follow the exact same curriculum as their peers in London, as the noble Baroness said.

The Bill prioritises EEA nations, because it seems that our trade deal requires us to recognise “comparable” qualifications. It is legally incoherent to accept a “comparable” qualification from Liechtenstein while rejecting an “identical” and “affiliated” qualification from Malta. We are treating a formal UK affiliate worse than a trade partner. These students sit the UK medical licensing assessment and they are taught by UK-trained consultants. As I said at Second Reading, it is a manifest absurdity that, under this Bill, a graduate from Liechtenstein with no UK degree and no UK training is prioritised over a Queen Mary student who holds a UK degree and is specifically prepared for our health service.

I strongly endorse the point made by the noble Baroness, Lady Gerada, regarding our free trade agreements. We are in an absurd position whereby a treaty obligation forces us to prioritise these “comparable” qualifications. This is not workforce planning; it is a diplomatic and regulatory own goal. As the noble Baroness explained, Amendment 19 offers a simple solution by adding Malta to the priority list. This honours the mutual recognition agreement held between the UK and Malta since 2009—an agreement the Department of Health explicitly renewed in 2024.

Amendments 15, 16 and 17 offer a broader solution based on the qualification. If a student holds a UK degree from a UK-registered institution and passes identical UK assessments, they should be treated as a UK graduate. The Minister fears displacement of domestic talent, yet the majority of these Maltese trainees are contractually obliged to return to Malta after their training. They are what can be described as a circulatory workforce: one that supports the NHS during their training years, without permanently blocking the consultant pipeline. They are the ideal workforce partner. As stated by the noble Baroness, Lady Gerada, Maltese surgeons have been licensed by our royal colleges since the 1830s. This is not a new or risky pipeline; it is a two-century year-old bond that the Bill carelessly severs.

Furthermore, we support Amendment 20 in the name of the noble Earl, Lord Howe, regarding people who qualify in the British Islands but who have trained abroad. We are all on the same page in advocating for these well-qualified students, who should be eligible to have the same priority in obtaining training jobs as those currently set out in the Bill. We have received heartbreaking correspondence from British nationals studying in eastern Europe, often because of the cap on places here, who intend to return to the NHS. One correspondent highlighted that we allow British dentists to return without these barriers. Why do we treat our future doctors differently?

Lord Winston Portrait Lord Winston (Lab)
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My Lords, it is an honour to support the noble Baroness, Lady Gerada. The best surgical training I had was with a Maltese surgeon, who was absolutely fantastic and taught me lessons I have never forgotten. One has to see that that cross-fertilisation happens across the NHS very often.

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Baroness Merron Portrait Baroness Merron (Lab)
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Again, I understand that the noble Baroness is coming forward with a solution and I appreciate her thoughts. I always reflect on what is said, but my initial reflection is that that does not deal with the fact that we already have a number of people. I asked this very question about continuing to prioritise them. It is significant even currently and that is part of the problem, although I understand what she is suggesting.

Baroness Merron Portrait Baroness Merron (Lab)
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I will take one more intervention, but it might be helpful to hear all that I have to say.

Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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I am sure that it will, but I just wanted to follow up the Minister’s pledge to deliver a letter to us in which she will set out precisely what her concerns are. Will the timing of that letter be early next week so that there is time to table amendments for Report to meet some of those concerns?

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Lord Stevens of Birmingham Portrait Lord Stevens of Birmingham (CB)
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My Lords, to help the Committee to assess the need for this further report that the noble Lord, Lord Kamall, just set out, it would be helpful if we could hear from the Minister when the Government will produce their replacement long-term workforce plan for the 2023 edition, which itself was deemed to be long term but ended up having a half-life of less than two years. How imminent is that and will it deal with the sorts of points that the noble Lord, Lord Kamall, rightly brings to our attention? When will we see the follow-on to the excellent Medical Training Review: Phase 1 Diagnostic Report, authored by the Chief Medical Officer and the previous National Medical Director of NHS England, published in October, which sets out these issues extremely well? The clue is in the title: it is the diagnosis. But when do we get the prescription? When does the treatment begin?

In a sense, the problem that we are dealing with through the Bill—again, as the noble Lord, Lord Kamall, just set out for us—owes its antecedents to the disconnect between the provision of NHS services and the ability to make smart, long-term workforce decisions. Unfortunately, for the period 2012 to 2022, those decisions on medical training were outwith the NHS and in effect were being controlled by the Treasury, which was constantly saying no to Health Ministers who were at the time trying to bring forward constructive solutions. Indeed, it was only when a former Secretary of State for Health became Chancellor that the situation was unblocked and we got the medical school expansion. Perhaps that is an inspiring example for the current Health Secretary—I do not know; perhaps he aspires higher. The fact is that we need that whole-government engagement on these kinds of questions to bring coherence and deal with these problems at root. Therefore, in responding to the noble Lord, Lord Kamall, any light that the Minister can shed on when precisely we will have line of sight to these sorts of questions would be, I think, of great benefit to the Committee.

Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, I support Amendment 22, standing in the name of the noble Lord, Lord Kamall. He absolutely made the case but, having heard what the Minister had to say on the previous group, I have a terrible certainty about what her response will be.

I assure the Minister that many of us want to find solutions, in the way that the noble Lord, Lord Stevens, mentions. The principles of the Bill are supported across the Committee; it is some of the detail that is in contention. We must be honest that the Bill deals with the symptom—competition ratios—not the cure, which is the bottleneck of insufficient specialty training places. I go back to the phrase that the noble Lord, Lord Stevens, used at Second Reading. We are simply reshuffling the queue.

This amendment places a necessary duty on the Secretary of State to review the adequacy of training places. We have received warnings from doctors in shortage specialties such as psychiatry and general practice, who fear that the Bill will drive away the international talent that we rely on. We need to know whether this legislation will succeed in retaining UK graduates or whether it will inadvertently exacerbate shortages by signalling to the global medical community that the NHS is closed for business. We cannot manage what we do not measure.

Baroness Merron Portrait Baroness Merron (Lab)
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My Lords, I welcome the debate that we have just had and I appreciate the support for what we are seeking to do, particularly from both Front Benches, as in the other place. I am most grateful for that.

The amendment tabled by the noble Lord, Lord Kamall, seeks to require the Secretary of State to review the impact of this Act within six months of Royal Assent and to require that that review is published and laid in Parliament. I understand the intent behind this amendment, but we do not feel that there is a need to accept it because the Government have already set out their impact-monitoring and evaluation plans within the published impact statement on 14 January.

The noble Lord’s amendment also specifies requirements that are not compatible with how recruitment cycles operate. He will understand that I want to report to your Lordships’ House only on the basis of proper information, as he would expect. However, data as specified in the amendment would not be available to allow us to meet those requirements or to allow sufficient time and flexibility for the investigation of impacts. However, I give the assurance that, should the Bill be passed, the Government will ensure that appropriate data is collected and investigated to facilitate the already proposed impact evaluation. I hope that this will be helpful.

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Lord Kamall Portrait Lord Kamall (Con)
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My Lords, in the absence of my noble friend Lady Coffey, who is not in her place, I hope it is acceptable if I move Amendment 26 and speak to Amendment 27. Both amendments seek to bring forward the commencement of the Bill rather than leaving its provisions to be implemented by regulations.

The Government say they need the Bill to pass as soon as possible but then refuse to commit to a date for commencement. Given that there is no date for implementation, noble Lords will rightly ask: what is the hurry with this Bill? There is a fundamental constitutional point here. Emergency legislation should be avoided as far as possible and, where it is necessary, it should be delivered urgently. In this case, we have been asked to fast-track the Bill without there being any apparent urgency to implement it.

The Minister sought to partly address this concern at Second Reading. Could she please explain exactly why the training allocation system will be unable to cope with the changed prioritisation arrangements introduced by the Bill if the BMA continues with its strike action during the coming months? What factors would frustrate the rollout? Would it be systems? Would it be the availability of officials? Would it be the ability of trusts and institutions to engage with the Department of Health and Social Care in a timely way? Or are there other reasons that noble Lords should be aware of? I hope this gives the Minister the opportunity to explain some of those reasons.

While we agree with the principle of giving UK graduates priority, and many noble Lords across the Committee have said this, we should take the time to have a proper debate on whether any other students should also be prioritised and in what order. We should have a debate to consider and debate questions such as: while qualifications may be similar, whether graduates from overseas branches of UK universities really do have similar experience to those who studied in the UK and worked in the NHS, or whether the country in which they studied has a patient profile similar to the UK, and whether in fact any of these distinctions are actually important. Another possible question that we should be looking at is whether historical prioritisation is still valid for today’s world, and whether it is worth while or too much effort to revisit some international agreements.

Instead of this much more considered debate, the Government tell us that they need to get the Bill on the statute book as soon as possible, but they are not forthcoming—perhaps not transparent—when it comes to implementation. Given this lack of clarity, I must say that there is a suspicion that the timing of the Bill and the Government’s rush to get it on to the statute book may appear to be not entirely unconnected with negotiations with the BMA resident doctors.

Whatever our politics and whichever Bench we sit on, legislation should be about making the lives of British people better. Although this Bill has the potential to help British citizens who are graduates of UK medical schools, the lack of transparency on implementation gives the impression that this legislation is more about giving the Secretary of State a negotiating chip in discussions with the BMA. I gently suggest that this is not a good enough reason for rushing such legislation, which is why my noble friend and I tabled these amendments. I look forward to hearing the Minister’s response.

Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, I will speak to Amendments 26 and 27 on commencement, proposed by the noble Lord, Lord Kamall. I confess that we are conflicted on these. This brings us back to the tension at the heart of the Bill. We have UK graduates urging immediate implementation to resolve their uncertainty; conversely, we have international medical graduates asking for delay or transition because the rules are changing mid-cycle. If the Government eventually accept the amendments in group 2, providing a fair transitional arrangement for those with NHS experience, then immediate commencement becomes less punitive. However, if they persist with the blunt ILR proxy for 2026 then rushing to commencement simply accelerates an injustice.

I urge the Minister to clarify when precisely the regulations for the 2026 cycle will be laid if this Bill passes and whether they will include the transitional protections we have argued for. I am somewhat pessimistic on that. Certainty is needed, but it must not come at the expense of fairness.

In that context, as we are at the end of Committee, I must ask the Minister to confirm that she is going to meet the cross-party group of those of us who have spoken at Second Reading and in Committee before Report takes place. I have kept my diary free for the Monday before Report and I know that the noble Baroness, Lady Gerada, mentioned that earlier. We would all welcome a face-to-face meeting with the Minister. She talked about us being co-operative, and we all realise the Government’s desire for speed, particularly in the context of the industrial dispute, but, quite frankly, it takes two to tango.

Baroness Merron Portrait Baroness Merron (Lab)
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I am grateful for the noble Lord’s advice in his last comment.

I thank noble Lords for their contributions. The noble Lord, Lord Kamall, spoke about what I am going to call the tension between emergency legislation and the commencement clause. I will start on that point. I hope he is aware that our intent is, of course, to commence the Bill as soon as we possibly can, subject to its passage through Parliament. That is why I am so grateful to noble Lords and to Parliament more broadly—both Houses—that they have agreed to expedite the progress of this Bill.

I will come back on to this later in a bit more detail but, as I have already stated, there is a genuine question about operational feasibility, if strikes are ongoing, due to the strain that they put on the system. I am sure everybody in your Lordships’ Chamber would understand that. I will now refer to the amendments, and I have some other points to answer some of the questions that were raised.

Amendment 26, tabled by the noble Baroness, Lady Coffey, and spoken to by the noble Lord, Lord Kamall, and Amendment 23, tabled by the noble Lord, Lord Mohammed, and spoken to by the noble Lord, Lord Clement-Jones, relate to the date upon which the Act comes into force. Both would remove the provision that allows the Secretary of State to appoint the commencement date.

We cannot accept these amendments, as they remove an important element—and I emphasise this point—of operational flexibility, should it be needed. The commencement provision within the Bill is not a mechanism for delay. It is, we believe, a necessary safeguard to ensure that systems planning and operational capacity are in place before the Act is brought into force. Noble Lords will also appreciate that it is a material question, as referred to by the noble Lord, Lord Kamall, about how possible it is to proceed if industrial action continues, given the strain that strikes put on the system.

It is our intention to commence the Bill as soon as we are able, but it is essential that the Secretary of State is able to take all the circumstances, including operational readiness, into account when deciding when the Act should come into force. I think that it is honest to say this. Amendment 26 also seeks to require the Act to come into force one month after it is passed. Specialty training offers must be made from March. Delaying commencement by even one month would leave insufficient time to implement prioritisation for this year’s application round. In short, fixing a commencement date one month after Royal Assent, as Amendment 26 suggests, would create a situation where the Bill comes into force too late to tackle the bottleneck problem that we seek to resolve—the one that it is designed to remedy for the 2026 year—while also removing our ability to commence the Act only when systems are ready to deliver it effectively.

On the comments about industrial action made by the noble Lord, Lord Kamall, I reconfirm that the Government have been in intensive and constructive discussions with the BMA resident doctors committee since the start of the new year. The aim is to try to bring an end to the damaging cycle of strikes, and to avoid what is undoubtedly further, unnecessary disruption for patients and NHS staff. We continue to hope that those talks result in an agreement that works for everyone, so that there will be no more strike action by resident doctors in 2026.

With regard to the noble Lord’s request for more detail on operational readiness, I know he understands that introducing reforms to such a large-scale recruitment process is a big undertaking. We do not want the risk of creating errors that could lead to further uncertainty for organisations, for educators and, most importantly, for our trainees. An effective commencement demands clear processes for delivery across the health system. The reality is that industrial action will put this at risk because it is a diversion of resources, as it always is.

The noble Lord, Lord Clement-Jones, asked about further engagement. I have already had engagement with a number of noble Lords, including both Front Benches. If it is possible to do so before Report, I will write again. Time is extremely short, so while I am always glad to do so, if the noble Lord will allow me to look at that in a practical sense, I will be pleased to. With that, I hope that the noble Lord will withdraw the amendment.

Medical Training (Prioritisation) Bill

Lord Clement-Jones Excerpts
2nd reading & Committee stage
Wednesday 4th February 2026

(1 week, 4 days ago)

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Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, I too thank the Minister for her introduction. I look forward to hearing from our two maiden speakers and add to the noble Earl’s welcome to the House to them. It is a pleasure to follow the noble Earl, and I agree with a great deal of what he said.

Let me say from the outset that we on these Benches support the underlying principles of the Bill. The Government’s impact statement makes the case that UK graduates are significantly more likely to remain in the NHS long term than their international counterparts. It is entirely reasonable that where the British taxpayer invests some £4 billion annually in medical education, there should be a secure pipeline for those graduates into our health service.

However, while the intent is sound, the execution is marred by serious flaws. Fairness requires that those who have relied on a long-standing government position are not disadvantaged by abrupt alterations. Six months’ notice is wholly inadequate for a decision with such a long lead-in time, and few could reasonably have expected such a significant change to be implemented with so little warning.

I want to highlight two specific areas where the Bill creates profound inequity—the treatment of UK university campuses overseas, specifically Queen Mary University of London in Malta, and the flawed criteria used to assess significant NHS experience for our international colleagues.

First, on the anomaly regarding Queen Mary University of London and its campus in Malta, until mid-last year, I was chair of Queen Mary University of London’s governing council. It is vital to understand that Queen Mary University in Malta is not a foreign institution or a private commercial venture; it is an integrated campus of a UK public university. Its students study a curriculum identical to that of their peers in London. They sit the same assessments, including the UK medical licensing assessment, and they are awarded the exact same GMC-approved primary medical qualification.

In her letter to noble Lords this week, and I welcome her correspondence, the Minister argued that these graduates should not be prioritised because they may lack familiarity with local epidemiology and NHS systems. With respect, that does not hold water. These students follow the exact same NHS-aligned curriculum as Queen Mary students in Whitechapel.

Contrast that with Clause 4, in which the Government rightly prioritise graduates from Ireland, but also prioritise graduates from Switzerland, Norway, Iceland and Liechtenstein. A graduate from Liechtenstein has no UK medical degree, has not sat the UK medical licensing assessment and has no training in UK epidemiology. Yet, under the Bill, they will be prioritised over a Queen Mary in Malta student who holds a UK degree and has been specifically prepared for the NHS. This is a manifest absurdity.

The Minister’s letter also suggests that including those students would undermine workforce planning because numbers are uncontrolled. That is incorrect. Queen Mary in Malta’s student numbers are capped by the Maltese Government at just 50 to 70 graduates a year—statistically negligible in a system of 11,000 places. To penalise them on such grounds is neither proportionate nor fair.

Furthermore, the Government’s own impact assessment justifies the Bill on the need to protect taxpayer investment, yet Queen Mary in Malta students are self-funded. This is not merely a matter of academic equivalence; these graduates provide the NHS with doctors trained to UK standards at no cost to the British taxpayer, representing a rare example of value without expenditure —precisely the kind of pipeline a fair system ought to support rather than disadvantage. By excluding them, the Government are working against their own value-for-money logic.

We also risk breaking a solemn international commitment. The Minister’s letter implies that our agreement with Malta is limited to ad hoc training. That downplays the reality. Since 2009, the UK and Malta have operated under a unique mutual recognition agreement regarding the foundation programme itself, explicitly renewed by the Department of Health and Social Care as recently as 2024. Malta is the only country in the world with this status. By unilaterally demoting these graduates, we are, in effect, tearing up a long-standing agreement with a Commonwealth partner—one that Malta’s own Minister for Health describes as having served both countries for over two centuries. Other universities, such as Newcastle University, which operates a similar campus in Malaysia, face similar predicaments. Its vice-chancellor has noted that its graduates too receive identical accreditation and transition seamlessly into the UK workforce.

Then there is the second critical flaw in the Bill: how it attempts to identify significant NHS experience for the upcoming 2026 recruitment round. Under Clause 2, the Government propose using immigration status, specifically indefinite leave to remain—ILR—as a crude proxy for NHS experience. This reveals a fundamental misunderstanding of medical training timelines. ILR typically, at the moment, requires five years of residence, yet UK graduates enter specialty training after just two years of the foundation programme. That creates a perverse experience gap. International doctors who have served on our front lines for three or four years, passed royal college exams, built a career portfolio and worked the same rotas as their UK colleagues will be treated as if they have no experience at all, simply because they have not yet clocked up the five years required for ILR. This, effectively, tells dedicated doctors that their three years of service counts for nothing.

In her earlier letter, the Minister defends this blunt proxy, as she did today, by claiming it was not operationally feasible to assess all applications for actual NHS experience in time for the 2026 cycle. We have received compelling evidence to the contrary. Doctors currently using the recruitment platform Oriel inform us that the system already captures data on months of NHS experience. The data exists, the mechanism to do this fairly exists, and to persist with the ILR requirement is to prioritise administrative convenience over the reality of clinical contribution. We should define significant experience not by visa status but by time served. A benchmark of two years of NHS experience would be equitable, and mirror the two years of core training required of UK graduates.

Furthermore, we have all received distressing correspondence regarding doctors on spousal visas. These are permanent residents, married to British citizens, with an unrestricted right to work, yet under the Bill they are placed in the lowest priority tier. We risk driving away not just those doctors but their British spouses who work in our public sector as families are forced to emigrate to find work.

There is a deep anxiety, in particular, regarding the mid-cycle implementation of these rules. We have received correspondence from doctors who have spent years building career portfolios and investing substantial resources based on published criteria, only to find the rules changing while the recruitment process is active. This creates procedural unfairness and huge instability for their families. If our guiding principle is, as it must be, fairness, then it cannot be right to introduce such consequential changes mid-cycle when candidates have already ordered their lives and careers around criteria that have stood in place for many years.

To cap it all, there is a glaring incoherence at the heart of the Government’s approach. Just days ago, the Education Secretary, Bridget Phillipson, announced a new strategy to grow our education exports to £40 billion a year by 2030. She explicitly encouraged our universities to expand transnational education and open campuses overseas. Yet in the Bill, the Department of Health and Social Care is actively undermining that very strategy. We cannot have the Department for Education urging universities to go global to boost the economy while the Department of Health and Social Care simultaneously pulls up the drawbridge against the very students who enrol. That is a fundamental contradiction.

For Queen Mary in Malta, the solution is simple: a minor amendment to Clause 4 to recognise its UK degree, or the inclusion of Malta in the priority list, honouring our 2009 agreement. For the broader issues affecting international medical graduates, we must abandon the blunt instrument of ILR and use the data we already have to recognise two years of service as the true mark of commitment. Let us not mar a necessary piece of legislation by failing to correct these obvious injustices.

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Baroness Merron Portrait Baroness Merron (Lab)
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My Lords, I am most grateful to all noble Lords who contributed to this debate for the support given, including just now by the noble Earl, Lord Effingham, to working with us, because I think there is general recognition that we have a problem that needs to be dealt with. I am very glad, as I said at the outset, to have been the Minister at the Dispatch Box when my noble friends Lord Duvall and Lord Roe made their moving maiden speeches. They both have many years of distinction in public service, and I know that that will continue as they bring their own unique experiences and views on the world to your Lordships’ House, which will be much enriched by their presence.

A strong and consistent theme has come through today’s debate: a shared concern for the well-being of NHS staff, recognition of the importance of workforce planning and the need for a sustainable health service. I am grateful for the thoughtful questions, and I will endeavour to answer as many as possible—I have already referred to some in my opening remarks. I will of course review the debate, as always, and I will be pleased to write to noble Lords on those matters I was not able to get to.

This legislation is about giving future generations of doctors trained in the UK a clearer and more secure pathway into NHS careers. It is about sustainable workforce planning and, as the noble Earl, Lord Howe, referred to, about fairness—to those who train here, to taxpayers who fund that training and to patients. As many noble Lords acknowledged, significant public investment goes into medical education every year, so it is right that we ask ourselves how that investment can be best aligned to what we need.

I have listened closely to the concerns raised today, particularly about the Bill’s impact on those who will not be prioritised. To reiterate, the way I look at this is that the Bill is about prioritisation, not exclusion. I assure your Lordships’ House that all eligible applicants will still be able to apply, and they will be offered places if vacancies remain after prioritised applicants have received theirs. We absolutely expect that to be the case; that is our experience. To be more specific, there are likely to be opportunities in specialties such as general practice, core psychiatry and internal medicine, which historically attract fewer applicants than the groups we are prioritising for 2026. We still need those people.

The noble Baroness, Lady Hollins, asked about possible unintended consequences for the UK’s international reputation. I believe our proud history of welcoming colleagues from across the world will continue and, as I have just said, international colleagues can, of course, continue to apply after prioritisation has taken place and there are vacancies.

On new specialty training posts, we have committed to creating 1,000 of these new posts over the next three years, focusing on specialties where there is greatest need. This is on top of creating 250 additional GP training places each year. The noble Earl, Lord Howe, raised questions about the availability of training places. Expansion will be matched with training capacity. We have not yet confirmed which specialties will receive the new posts, but we will ensure that expansion is targeted where patient demand and workforce pressures are the most acute.

I am glad that the noble Lord, Lord Stevens, made reference to the cancer plan. It was a bright spot in today’s news—I am sure all noble Lords will understand —and has not had the airtime it ought to have had, so I am most grateful to him. What I can tell the noble Lord about the creation of new specialty training posts is that there will be a focus on those with greatest need. We will set out steps in due course and I look forward to keeping the noble Lord informed. Non-prioritised graduates will also continue to have routes into NHS careers through locally employed doctor roles, gaining experience that can support future progression and prioritisation.

Let me turn to some of the specific points that were raised by noble Lords. The noble Lord, Lord Patel, asked about British citizens who have graduated from medical schools outside the UK and will not be in the priority group. I understand why these concerns are being raised but, going back to the core of the Bill, to prioritise them would undermine our aim to build UK-trained capacity while ensuring we do not provide any more foundation programme places than we need. To reiterate, UK-trained doctors are more likely to work in the NHS for longer, and retention is an issue that is much discussed in your Lordships’ House. They will be better equipped to deliver tailored healthcare that suits the UK’s population because of what they understand. Reference was made to the provision extending also to the Republic of Ireland graduates. Their inclusion ensures consistency in workforce planning across both jurisdictions, which reflects the long-standing protocol rights for movement and employment. That was something in which the noble Lord, Lord Clement-Jones, was particularly interested.

On specialty training places starting in 2026, British citizens will be prioritised, because that is one of the prioritised immigration statuses being used as a proxy to indicate someone who is likely to have significant experience of the NHS. Why? Because applications for posts starting in 2026 have already been made. Prioritisation is only at offer stage because shortlisting is under way, so it is a timing matter about implementation. From 2027, immigration status will no longer automatically determine priority, but we have the ability to set out in regulations the persons who will be prioritised based on criteria which indicate they are likely to have significant NHS experience, or based on their immigration status. As I said earlier, we will be engaging with our partners to work out how best to define that.

On the point made by a number of noble Lords, including the noble Earl, Lord Howe, and the noble Lords, Lord Clement-Jones and Lord Stevens, about graduates of overseas campuses, including Malta, which I will turn to presently, having heard the noble Baroness, Lady Gerada, the UK foundation programme applications for 2026 show that there are almost 300 applicants from these overseas campuses, of whom 152 are UK nationals. This is a substantial number and, if we were to do what is being asked—to prioritise graduates of UK overseas campuses—our estimation is that this could encourage universities to establish further international partnerships which would simply increase pressure still further. It also risks creating a loophole that would encourage new overseas partnerships to seek preferential access to the foundation programme across the UK. The noble Lord, Lord Clement-Jones, picked out Liechtenstein in particular, but, as the noble Baroness, Lady Coffey, referred to, we are talking about the EFTA countries, which include Liechtenstein, and they are prioritised simply because of existing international agreements that we are obliged to honour. However, in practice, not all these countries are going to have eligible applicants.

Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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I hope the Minister does not mind. Does the Minister think that the agreement with Malta should be honoured as well?

Baroness Merron Portrait Baroness Merron (Lab)
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I am coming on to this, but the agreement in respect of Malta that I would refer to is a reciprocal health agreement. It does not apply in this area. It is about the reciprocal provision of healthcare. I will turn to Malta, however, after saying a brief word about overseas campuses generally.

Just to re-emphasise, overseas campus students are not part of the numbers that the Government are setting. We do not have that control. If we prioritised those graduates as well, that would eat away at the very core of the Bill and the things people actually want us to do.

The noble Baroness, Lady Finlay, and the noble Lord, Lord Clement-Jones, wanted an indication of how this would all align with the international education strategy. The Bill does not conflict with this, because the international education strategy supports universities expanding internationally. It does not prevent UK universities delivering medical degrees overseas. That strategy stays in place.

I turn to Malta for the noble Baroness, Lady Gerada—

NHS Procurement: Palantir Contract

Lord Clement-Jones Excerpts
Thursday 22nd June 2023

(2 years, 7 months ago)

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Lord Markham Portrait Lord Markham (Con)
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The noble Baroness is correct: public confidence is vital, particularly in the case of data, where we are concerned about privacy. We are arranging a briefing of noble Lords so that everyone can have the opportunity to understand what we are talking about here, which is almost like the plumbing of the system. The NHS maintains primacy of use—it is the only organisation allowed to use it—and privacy will be maintained at all times. It is much better to think of whoever wins this contract—we do not know who they are—as just the technology provider, like Microsoft, for instance. We use private sector companies for technology all the time. The key thing is that the provider is protected. That is the NHS, and no one else can get access.

Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, the Minister talked about the plumbing, but is it not the case that, with this further contract, which has had no tendering, Palantir’s Foundry system is further embedded in the federated data platform of the NHS, and what we are effectively seeing is what the Doctors’ Association UK calls a “monopoly lock-in” that is therefore a shoe-in for the award of the next contract?

Health and Care Bill

Lord Clement-Jones Excerpts
Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, briefly, I support the remarks of the noble Lord, Lord Hunt, regarding Motions F and F1. He, assisted by my noble friend Lady Brinton and I, has pursued the question of the future of data governance in the NHS with great determination and persistence. I pay tribute to him and to medConfidential in that respect. I know that the Minister, the noble Lord, Lord Kamall, is equally determined to make sure that data governance in the new structures is designed to secure public trust. I very much hope that he will give the assurances sought by the noble Lord, Lord Hunt.

The key problem we identified early on was the conflict of interest referred to by the noble Lord, Lord Hunt, with NHS England in effect marking its own homework, and those who have data governance responsibility reporting directly to senior managers within the digital transformation directorate. I hope that the assurances to be given by the Minister will set out a clear set of governance duties on transparency of oversight, particularly where NHS England is exercising its own statutory powers internally. I look forward to what the Minister has to say.

Baroness Walmsley Portrait Baroness Walmsley (LD)
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My Lords, I plan to address matters in the group that have not been addressed by my noble friends. They are workforce planning, reconfiguration and organ tourism.

First, on Motion K, on organ tourism, I congratulate the noble Lord, Lord Hunt of Kings Heath, my noble friend Lady Northover and others on their success in convincing the Government that something must be done about this dreadful trade. I also thank the Minister for listening.

On Motions B and B1, we support the noble Baroness, Lady Cumberlege, and will be right behind her when she leads us into the electronic Content Lobby on her Motion B1. It was made clear during earlier stages of the Bill that Peers across the House believe proper planning for training and providing a safe health and care workforce is essential. We also hear that almost 90% of trust leaders do not think the NHS has robust plans in place to deal with the workforce shortage. We are asking a lot of the NHS and care workforce at the moment; they are badly understaffed but, at the same time, are being asked to reduce the backlog of treatments that built up during the pandemic, while Covid-19 is still rampant in the population and thousands of patients are still in hospital with that as the primary cause.

In these circumstances, we have a desperate need for a reliable system to plan for and provide the staff we need, but nobody has confidence in the current system—if you can call it that. However, it seems that the Treasury has stuck its oar in. I find that rather odd, since neither the Bill as drafted nor the various amendments of the noble Baroness, Lady Cumberlege, have mandated the Treasury to fund the numbers of workers at every level who may be identified as necessary to deliver the health and care we need.

I accept that, when the yawning gap becomes clear between the numbers we have and the numbers we need for safe care, there would indeed be pressure on the Treasury to provide the money. However, it has been pointed out many times—including this afternoon, by the noble Baroness, Lady Cumberlege—that the NHS spends £6.2 billion every year on expensive agency staff, whose roles could be provided much more cheaply, and with better continuity for patients, by permanent employed staff. Considerable savings could be made to offset this.

It is significant that the Government are resisting the noble Baroness’s amendment. They know very well that the reviews she recommends would shine a light on the fact that the NHS and care systems do not know what they have got or need, and are badly short-staffed. The Government would be pressured to do something about it.

Since the Ockenden report, something else which is rather crazy has emerged. The Government have agreed to comply with all Ockenden’s recommendations, including on planning for and providing adequate staff in obstetrics and gynaecology. Hopefully, all maternity units will be safer in future, but it would be ridiculous to have a maternity unit adequately staffed in the same hospital as a cancer or stroke unit that was not. In voting for the amendment from the noble Baroness, Lady Cumberlege, we will attempt to save the Government from making such a dreadful and unnecessary mistake. We will be voting for safe health and care services in the future, in the interests of patients and staff alike.

On Motions C and C1, we support the amendment in the name of the noble Baroness, Lady Thornton, which she will no doubt speak to in a moment. In voting for this amendment, we will again be attempting to save the Secretary of State for Health and Care from getting himself into an awful pickle. There may be far too much temptation for a Secretary of State to use the powers in the Bill as it stands to meddle in matters far better decided by the professionals and local authorities on the ground. A clear process, which is rooted in local accountability, already exists for reviewing proposals for NHS reconfiguration—there is no call for the Secretary of State to be further involved except now and then if an election is in the offing. The Government have emphasised accountability throughout this Bill, but that accountability must be at the right level. Many of the decisions that might be made under the power that we are attempting to curtail today should be accountable to local people through those operating the local integrated care systems. By interfering, the Secretary of State may well corrode the very accountability that the Government say they want. We will be voting with the noble Baroness, Lady Thornton.

Health and Care Bill

Lord Clement-Jones Excerpts
Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, I rise briefly to speak to Amendments 60 and 116, and I congratulate my noble friend Lady Brinton and the noble Lord, Lord Hunt, on their persistence in pressing these two items, because they are extremely important. I also thank the Minister for his engagement, both on the Floor of the House and in extensive correspondence. This has been really quite a complicated trail. I feel as though we have been in a maze where we have had to follow a bit of string, finding the way through into data governance in the NHS.

We have had to follow certain key principles, which we all share and which the Minister has expressed, including the protection of privacy, the right of opt-out, the value of health data and, above all, the imperative to retain public trust. Given the importance of the new ICB regime, I very much hope that the Minister will be able to comprehensively answer my noble friend’s questions.

But if we have taken the time to get to this point of really understanding—or beginning to understand—the kind of data governance that the ICBs will be subject to, it raises the question of what future guidance will be in place. I very much hope that the Minister can absolutely give us the assurance that there will be new, clear guidance, along the lines I hope he is going to express in response to my noble friend, as soon as possible, especially given the speeding up of the electronic patient record programme, as my noble friend Lady Brinton said. That is, of course, desirable, but it has to be done in a safe manner.

Health and Care Bill

Lord Clement-Jones Excerpts
This Bill proposes giving police those powers for any criminal investigation. It is absolutely wrong. I refer your Lordships to recent police cases of sexual assault, where we know they have also trawled victims’ telephones and computer data for any information they can find. Would these clauses allow similar fishing expeditions on their private and confidential medical data? Would they also apply to those who might be loosely associated with potential criminals? What about family members? Is it intended that their data be similarly trawled? Where does this end? This entire clause breaches an individual’s right to their medical data being kept confidential, other than in exceptional circumstances. It removes the power from the individual’s GP to make such a decision in exceptional circumstances. Worse, it enables commissioning staff and directors at an ICB to be required to hand over data to the police without the knowledge of the GP. It is totally unacceptable, and I entirely support this amendment.
Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, I support the amendment in the name of the noble Lord, Lord Hunt, to which I have added my name. He is not the only one to be concerned about this part of the Bill. My noble friends Lady Brinton and Lady Harris have delivered powerful support and a demonstration of why we have to be absolutely vigilant about access to, and sharing of, personal data, as they were so successfully on the police Bill. We must not repeat those experiences.

We will talk further and more comprehensively about data later in Committee. In the meantime, Amendment 145, as the noble Lord, Lord Hunt, explained, tries to illicit from Government their intention behind these disclosure powers for ICBs in new Section 14Z61 in Clause 20 with regard to information, whether personal data is involved and what the safeguards are. New Section 14Z61 sets out the provisions whereby

“An integrated care board may disclose information obtained by it”


in the exercise of its power. As the noble Lord, Lord Hunt, said, the catch-all condition in new Section 14Z61(1)(f) under which disclosure can be made

“for the purposes of facilitating the exercise of any of the integrated board’s functions”

seems remarkably open-ended. My noble friends have also pointed out the sheer width of paragraphs (e), (g) and (h), which go even further than those originally proposed in the police Bill and raise crucial questions for the Minister to answer.

Amendment 145 aims to ensure that an ICB cannot disclose information where this is patients’ personal data. In my last intervention on the group headed by Amendment 26, I, like the noble Lord, Lord Hunt, expressed my support for the NHS’s digital transformation programme. It is clear, as the noble Lord says, that there is great potential growth in new technologies using data such as AI and machine learning. However, there is an absolute imperative to have the right safeguards in place in relation to duties and data. This is very much aligned with transparency in public information and engagement, particularly in this context. Transparency, choice and consent are crucial, as the noble Lord, Lord Hunt, says.

We have all looked forward to the Goldacre review, but I am not convinced that it will range wide enough and cover the governance arrangements needed to preserve and enhance public trust in the sharing and use of health data, but we will see. I look forward to the debate towards the end of Committee when we discuss the wider aspects of the Bill, when we will produce further illustrations of the rather cavalier way in which the Government, the department and the NHS have treated personal data. Not least of these is what has been called the attempted GP data grab of last year. In the meantime, I hope the Minister will be able to give assurances that the powers in Section 14Z61 will be very limited.

Baroness Finlay of Llandaff Portrait Baroness Finlay of Llandaff (CB)
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My Lords, from the perspective of a clinician, I support this amendment very strongly. If it is not adopted, I can see it being imperative, in any doctor’s consultation, to warn the patient that their data could be accessible and to be very careful about what is recorded in the clinical record. Very often, patients come to see a doctor, possibly at a very early stage of slightly disordered thinking or because they have undertaken a potentially high-risk activity, often in the sexual domain, and are worried that they may have contracted some condition or other. If you inhibit that ability to see a doctor early, you will further drive people into whatever condition is beginning to emerge, so it will not be known about until later. That applies particularly in mental health, where early intervention might prevent a condition from escalating.

I can see that, without an amendment such as the one proposed by the noble Lord, Lord Hunt of Kings Heath, every clinical consultation will have to be conducted with extreme caution, because of potential access to data.

Dementia: Art and Music-based Interventions

Lord Clement-Jones Excerpts
Monday 22nd November 2021

(4 years, 2 months ago)

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Lord Kamall Portrait Lord Kamall (Con)
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I thank the noble Lord for his invitation to perform live—I am not sure that he will feel the same way after hearing my blues band. Last year, NHS England and NHS Improvement, in collaboration with the National Academy for Social Prescribing, the Alzheimer’s Society and Music for Dementia, facilitated a series of webinars. We are working in consultation with them. In February 2021, Music for Dementia also published social prescribing guides for link workers to help expand music prescriptions. The important thing here is that we are consulting with stakeholders.

Lord Clement-Jones Portrait Lord Clement-Jones (LD)
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My Lords, for more dementia patients to gain access to music therapy through social prescribing, there must be more training on the value of music for carers and healthcare practitioners and greater support for musicians to train as music therapists, and music education must be a much more mainstream part of primary and secondary school education. What assurance can the Minister give that the necessary government cross-departmental action is being taken to deliver on this?

Lord Kamall Portrait Lord Kamall (Con)
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The department itself is working closely with Music for Dementia and other organisations. Across government, we are looking at music, beyond just performance, to see how it can impact our lives and the role that it can have in levelling up and community cohesion, for example. Across government, I am sure that a number of departments are looking at this.

Medicines and Medical Devices Bill

Lord Clement-Jones Excerpts
Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021

(5 years, 1 month ago)

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There can surely be no objection to this minimal protection being required when contemplating the broad power being taken by the Government in decisions on the international sharing of valuable public data.
Lord Clement-Jones Portrait Lord Clement-Jones (LD) [V]
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My Lords, it is a pleasure to follow the noble Lord, Lord Patel. I support and will speak to Amendments 18, 36 and 57, which have been so well introduced and explained by him, and which I have signed, and will speak to my own Amendment 20.

We have had discussions on this Bill and the Trade Bill about health data and trade issues. The two Bills are intimately connected, and this amendment is very complementary to Amendment 11, passed on Report of the Trade Bill on 7 December. There was no debate or discussion about the new Clauses 7 and 12 and the new subsection in Clause 37 when they were introduced in Grand Committee. On both counts it is therefore vital that we get to grips with them today. I welcome the Minister’s new amendments, which he has spoken to and which take us a step further in terms of patient consent, definition of information and relevant persons. But I have signed, and these Benches support, the additional amendments to those clauses and subsection put forward by the noble Baroness, Lady Thornton, to ensure that we further tighten these provisions. Specifically, we want to tie this to international co-operation on pharmacovigilance or in monitoring the performance and safety of medical devices, and a public interest test put around the disclosure of health data, for all the reasons put forward by the noble Lord, Lord Patel.

As I said when the House debated these issues on Report of the Trade Bill and later passed the amendment, NHS data is a precious commodity, especially given the many transactions between technology, telecoms and pharma companies concerned with NHS data. I cited a recent report in which EY estimated that the value of NHS data could be around £10 billion a year in the benefit delivered, and the fact that the Department of Health and Social Care is preparing to publish its national health and care data strategy shortly, in which it is expected to prioritise the

“safe, effective and ethical use of data-driven technologies, such as artificial intelligence, to deliver fairer health outcomes.”

I mentioned too that, while acknowledging that the UK is a leading player in the fields of life sciences and biosciences, health professionals have strongly argued that free trade deals risk compromising the safe storage and processing of NHS data in much the way that the noble Lord, Lord Patel, has mentioned.

Through the amendment to the Trade Bill from the noble Baroness, Lady Thornton, and likewise this amendment, the objective is to ensure that it is the NHS, not US big tech companies and drug giants, that reaps the benefit of all this data. This is especially important given what the Ada Lovelace Institute called in its report, The Data Will See You Now, the “datafication” of health, which, it says, has profound consequences for who can access data about health, how we practically and legally define health data, and our relationship with our own well-being and the healthcare system. Health information can now be inferred from non-health data, and data about health can be used for purposes beyond healthcare. Harnessing the value of healthcare data must therefore be allied with ensuring that adequate protections are put in place in trade agreements, if that value is not to be given or traded away.

At the time, I raised questions about the provisions of the UK-Japan trade agreement, and there is no doubt that these questions will linger unless an amendment of this kind, to both this Bill and the Trade Bill, goes forward.

There have been many shortcomings in the sharing of data between various parts of the health service, care sector and Civil Service. The development of the Covid-19 app and the way that the Government have procured contracts for data management with the private sector have not improved public trust in their approach to data use. That is why clear safeguards are needed to ensure that, in trade deals and international agreements, our publicly held data is safe from exploitation where it is not for public benefit.

On Tuesday, the Minister heavily emphasised the public interest test that he wanted to see applied to the sharing and use of Clause 3 information. The data covered by Clauses 7, 12 and 37 is even more important. He used the same language today and in correspondence, so I hope he can accept these amendments. As the noble Lord, Lord Patel, has said, we also want to see the aspect of patient consent clarified.

I turn briefly to Amendment 20. I welcome the Minister’s Amendment 19, but Amendment 20 is designed to get the Minister to further clarify what is meant by “consent” in Clause 7. Informed consent is very much a familiar concept in healthcare, especially in treatment and trials, and, indeed, that is effectively the definition on the NHS website. It depends on capacity, explanation, understanding and it being voluntary. That is why my amendment would insert the word “informed”, to make it abundantly clear that, at the very least, that is what is intended here. I look forward to the Minister’s reply.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, it is a great pleasure to follow the noble Lord, Lord Clement-Jones, and I welcome the opportunity to debate this important group of amendments. I welcome the government amendments, but feel that my noble friend Lady Thornton’s amendment is very important, as indeed are some of the others in this group.

I have always been strongly in favour of using patient information. It is a rich source of data for scientists to pursue in the search for medical advances. We all benefit, and I am sure that the great majority of the public see this and are agreeable to information being shared. But we must have appropriate safeguards, and that is why the government amendments to restrict the persons to whom information may be disclosed, and the addition of a definition of patient information and the need for individual patient consent, are all very welcome.

My understanding, however, is that information pertaining to patients can be shared where it has been rendered non-identifiable. As the University of Birmingham has commented, this may be in line with current data protection principles but there is still a danger of a care.data-type problem, in that the provisions might allow the Government to share with “relevant persons”—as they are now called—outside the UK information they hold on patient data through NHS bodies without consent when anonymised. The noble Lord, Lord Patel, referred to some of the issues with care.data. The stricter definition of patient information may address some of the concerns that the definition of patient data—being restricted to identifiable data—left anonymised data open for use or barter as part of international agreements. Part of this broader concern is that aggregate data can reveal patterns that may allow for re-identification, especially for small patient clusters in respect of rare diseases and conditions.

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Lord Russell of Liverpool Portrait The Deputy Speaker (Lord Russell of Liverpool) (CB)
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Does the noble Lord, Lord Clement-Jones, wish to move Amendment 20, as an amendment to Amendment 19?

Lord Clement-Jones Portrait Lord Clement-Jones (LD) [V]
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[Inaudible]—very much about informed consent, but, nevertheless, I will not move the amendment.

Amendment 20 (to Amendment 19) not moved.

Medicines and Medical Devices Bill

Lord Clement-Jones Excerpts
Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021

(5 years, 1 month ago)

Lords Chamber
Read 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 154-II(Rev) Revised second marshalled list for Report - (12 Jan 2021)
Moved by
14: Clause 3, page 3, line 4, leave out “for any purpose to do with human medicines” and insert “for the purpose of ensuring patient safety”
Member’s explanatory statement
This amendment would narrow the use of data in relation to falsified medicines to that which ensures patient safety.
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Lord Clement-Jones Portrait Lord Clement-Jones (LD) [V]
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My Lords, on 4 November in Grand Committee, the noble Baroness, Lady Thornton, and my noble friend Lady Jolly introduced amendments designed to limit the ambit of the information-gathering powers under Clause 3, which deals with falsified medicines. I raised the subject at Second Reading but was unable to be present for the debate in Grand Committee.

The Minister, the noble Lord, Lord Bethell, said in resisting the amendments:

“We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders.”


It was not at all clear what the Minister meant by “exploring creative uses of information”, and in fact it was quite concerning given that these have not been set out anywhere in any consultation document. However, he went on to say:

“I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee.”—[Official Report, 4/11/20; col. GC 326.]


Of course, as the result of the very welcome government Amendment 4, the safeguarding of public health is the key objective, and by Amendment 6, Clause 1(3) has been tightened up too. However, having carefully considered these amendments and the Minister’s previous response, I must still question his interpretation of Clause 3 and how it interacts with Clause 1. Clause 3(1)(b) currently says that the regulations may make provision about

“the use, retention and disclosure, for any purpose to do with human medicines, of information collected for the purpose of preventing the supply of falsified human medicines.”

At best there is a conflict between the two clauses, and at worst Clause 3 is open-ended and gives the Government far too much discretion in the scope of regulations under Clause 3.

In the discussions we have had with the Minister between Committee and Report—for which I am grateful—it became clearer that we need to ensure that this information regarding falsified medicines is used for limited purposes. The Minister cited a whole range of possible uses for the data, which came as a considerable surprise. As I said earlier, there has been no industry consultation, despite considerable ambition on the department’s behalf. That is why in this amendment we have tied the purpose to “ensuring patient safety”. What possible objection could there be to this limitation? Why would the Government want any wider scope, especially if the Minister believes that Clause 1 already provides a limitation?

I have now seen the brief announcement issued by the department on the consultation on the regulations to be carried out on a new national scheme. It says:

“We are committed to public consultation around the need and details of any national scheme, as well as a specific consultation on the use of data collected as part of any scheme.”


That lacks detail, to say the least.

Many noble Lords have been briefed by the Company Chemists’ Association about the commercial sensitivity of this data. As my noble friend Lady Jolly said in Grand Committee:

“The Department of Health and Social Care already has access to a very wide range of data on the sales of medicines, and their use in the UK, under the Health Service Products (Provision and Disclosure of Information) Regulations 2018. These require manufacturers, wholesalers and pharmacies to provide summaries of products sold and prices paid. Ministers can request more detailed information if required.”—[Official Report, 4/11/20; col. GC 324.]


Given this access and the known sensitivities about falsified medicines directive data, it is unclear why the department has included this sweeping provision in Clause 3(1)(b). I described this as “legislative creep” at Second Reading. It goes well beyond the EU falsified medicines directive of 2011 and the associated delegated regulation of 2016. Of course, this was not acknowledged in the Commons by the Minister, Jo Churchill. As a result of the efforts of several noble Lords, the changes proposed to the FMD provisions are now out in the open—but that does not make it any more acceptable.

This might seem rather a specialised part of the Bill, but clarity about the scope of Clause 3 is vital if we are to have confidence that a suitable scheme for falsified medicines data will be put in place that does not go well beyond the current scheme in terms of the sensitive data that is collected and used. I hope the Minister can do better than last time in giving greater assurance about the ambit of Clause 3 so that I do not need to divide the House. I beg to move.

Lord Hunt of Kings Heath Portrait Lord Hunt of Kings Heath (Lab) [V]
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My Lords, it is a great pleasure to support the noble Lord, Lord Clement -Jones, and my noble friend Lady Thornton. I urge the Minister to respond, as the noble Lord asked, on how Clause 3 will actually be used. It did not help that the Explanatory Notes made no mention of what the noble Lord described tonight and at Second Reading as “legislative creep”.

We have had submissions from a number of organisations that make the point that the wording goes beyond the current EU legislation, which was carefully implemented after extensive consultation with the relevant bodies. That is from the Company Chemists’ Association. The ABPI said that the falsified medicines directive was introduced as a barrier to counterfeit and falsified medicines entering the supply chain, thus reducing the potential risk of harm to patients, that the ABPI and its members have worked to fund and implement the falsified medicines directive, and that any future considerations under this clause must include full consultation with industry.

So there is general concern in the industry about how the clause will be used. We know that the department already has access to a wide range of data on medicines sales and use in the UK under the Health Service Products (Provision and Disclosure of Information) Regulations. Given this and the known sensitivities around falsified medicines data, I am still unclear why the department wants to extend the purposes for which data is collected under a future UK system. I know that we were very privileged—

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am enormously grateful for that helpful debate. Let me try to provide some of the clarity and reassurances noble Lords have sought. Amendment 14 to Clause 3 would add constraints to the use of data collected as part of the operation of any national falsified medicines scheme. I understand that the intention of Amendment 14, in the name of the noble Lord, Lord Clement-Jones, is to prevent the use of data collected for any additional use other than for the purpose of ensuring patient safety. We discussed this at length in Committee and afterwards, and I am grateful to the noble Lord and to other noble Lords who have given up their time to discuss this important issue. I know that the noble Lord has returned to this because he thinks it is worth continued debate, so I would like to reassure him that we have thought very carefully indeed about the power in Clause 3(1)(b).

I will start with the context of the power to use information collected as part of any potential future national falsified medicines scheme. First, it is important to note that the overarching principles of the Bill set out in Clause 1 also apply to, and are constrained by, the powers in Clause 3.

Amendment 4 in my name would ensure that in making regulatory changes under Clause 3—not just around how information will be used—the appropriate authority’s overarching objective must be safeguarding public health. In making that assessment, one of the things the appropriate authority must have regard to is the safety of medicines. Further, we have provided for a clear and unambiguous lock on patient safety; that is, as part of the decision-making process behind regulatory changes, if proposed changes have an impact on the safety of human medicines, the appropriate authority may make those changes only if the benefits outweigh the risks.

Secondly, of course, any regulations providing a framework for the use of the information will be subject to parliamentary scrutiny under the draft affirmative procedure. So, the scope of Clause 3(1)(b), which is the focus of our discussion, is not unfettered. I have discussed previously the statutory requirement to consult before making regulatory changes. Powers at Clause 3(1)(a), (2) and (3) will provide us with the means to make the regulatory changes to establish a verification system, if appropriate. As part of the effective operation of any such system, information will need to be collected. It is only once we have established the need for a verification system, and how it could work, that we can fully consider how the information it collects could be used to deliver additional benefits for the UK and for patients. Clause 3(1)(b) and (3) enable us to make appropriate best use of the data collected as part of a national focused scheme and ensure that the appropriate authority must have regard to the importance of ensuring that information is retained securely.

I want to reassure noble Lords by being as clear as I can that the data in question is that which would be collected for the prevention of the supply of falsified medicines—that is, as part of the operation of any verification scheme. I reassure noble Lords that we could not expand the data being collected using Clause 3(1)(b) as part of a verification scheme. However, we want to maximise the use of data collected as part of any verification scheme where it is in the public interest. In this, we would be learning from the EU scheme, which, for example, allows data to be used beyond patient safety for reimbursement purposes and in delivering a solution that works at a national level. I reassure the Chamber by being as clear as I can be that the powers in Clause 3 do not include the collection of patient data. As with the current European scheme, there are no plans for any future national falsified medicines system to collect patient data.

My concern is that putting such a limit on the use of information at this time could constrain or limit options ahead of our engagement with stakeholders. Critically, it may not allow for the data to be used for all potential research purposes. We are not in a position at this moment, ahead of our engagement with stakeholders, to list all the potential ways in which data sources might be combined for research and wider public health purposes, which can go beyond patient safety. We want to be guided by our stakeholder engagement and not to restrict that process unnecessarily before we have had a chance to hear how this data could be used for public interest purposes.

We are also proposing a staged approach to engagement and consultation. We are committing to a clear and separate consultation and engagement: first, a consultation around the need for and details of any system concerned with the prevention of falsified medicines; and secondly, a specific consultation around other uses of the data collected under Clause 3(1)(b). As I have said, any regulatory changes that will provide a framework for the use of the information would be subject to parliamentary scrutiny under the draft affirmative procedure.

I believe that by developing these proposals through consultation and engagement, we are improving our policy-making and its subsequent implementation. I remind the House that we have no scope for changing these provisions at Third Reading, so if the noble Lord, Lord Clement-Jones, wants to press the matter, he will need to do that today, but I hope instead that he will have had enough clarity and reassurances from the Dispatch Box to be able to withdraw his amendment.

Lord Clement-Jones Portrait Lord Clement-Jones (LD) [V]
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I thank my noble friend Lady Jolly, the noble Lord, Lord Hunt, and the noble Baroness, Lady Thornton, for their helpful contributions and support today. I also thank the Minister for his reply; I regard it as something of a curate’s egg, but I recognise the thought that has gone into it, particularly his statement on the overarching principles in Clause 1 governing Clause 3 and the fact that the benefits must outweigh the risks in any scheme. He talked about the affirmative procedure; I very much hope that we will retain the super-affirmative procedure, which encourages me that there will be greater scrutiny of any new framework.

The Minister also spoke about the statutory duty to consult on proposals and the duty to secure data. He said that no patient data was being used and that, at the end of the day, the essence of this is to maximise the use of data where it is in the public interest. He gave research as an example that might be outside patient safety—I doubt it, but he thought it might be interpreted as going beyond patient safety. I was very struck by the noble Baroness, Lady Thornton, saying that there was an element in this of having a power that might come in useful; indeed, the Minister almost repeated that in saying, “We’ll see what data we have collected.”

I take some comfort from what the Minister has said. We have had some very productive debates and some important amendments secured, so I will not press this amendment today. However, the noble Lord probably has to suffer the potential of being immortalised on a Pepper v Hart basis if there is any subsequent dispute about the width of regulations made under this clause and whether Clause 1 limits the scope of Clause 3. I am sure he looks forward to that. In the meantime, I beg leave to withdraw my amendment.

Amendment 14 withdrawn.

Medicines and Medical Devices Bill

Lord Clement-Jones Excerpts
Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020

(5 years, 3 months ago)

Grand Committee
Read 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)
I know that the Minister is absolutely committed to patient safety as well as to facilitating innovation in the development of medicines and medical devices, as was made plain only recently when NHSX launched its digital technology assessment criteria for health and social care in beta. However, there has perhaps never been a more thoroughgoing appreciation of the inextricable link between health and wealth than is the case at present, during the ongoing public health emergency. Algorithms that impact the exam results that people receive impact their life chances. We must ensure that algorithms with the potential to impact people’s health, and which could even represent a threat to life, are appropriately regulated. As such, I hope that the Government will make good the Minister’s commitment to champion patient safety, in parallel with taking steps to ensure that the UK is among the best places in the world to develop, test and deploy an array of next-generation medical devices. I thank noble Lords for their patience in listening to this long speech and I beg to move.
Lord Clement-Jones Portrait Lord Clement-Jones (LD) [V]
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My Lords, I want to strongly support the amendments in the name of the noble Lord, Lord Freyberg, and myself, and to commend him on an extraordinarily well-informed speech in support of them. I absolutely support the amendments, in particular Amendment 83, which calls for the comprehensive technical review.

The noble Lord made all the points about dynamic algorithms, deep neural networks, the whole question of self-alteration by algorithm and the absolute need to avoid black-box AI, which chime strongly with everything that I know about artificial intelligence. I welcome, right at the beginning, the Minister’s agreement to meet the noble Lord, Lord Freyberg, and me to discuss these issues further. So I am taking this debate not as the end of the road but as the beginning of a dialogue on these issues.

The big question is: does the Minister really believe that we should be reviewing the definition of “medical device”? Does he believe that it is out of date but is simply reluctant to enshrine it in legislation? All Ministers hate their legislation being tampered with, but I am afraid that I am quite sure that this Bill will suffer some treatment on Report.

Even more important than the definitions is the question of how regulation takes effect on these medical devices, in particular on the new medical devices that incorporate algorithms in this way, and whether the regulation is fit for purpose. Without going into the paper at too great a length, I commend to the Minister the discussion paper from the US Food and Drug Administration, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning-Based Software as a Medical Device. I have searched but I could not find that the MHRA had done anything of an equivalent quality. I will take a few quotes from the document that illustrate that this is exactly the kind of work that our own regulator needs to do.

The document states:

“Artificial intelligence- and machine-learning-based technologies have the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of healthcare every day … The traditional paradigm of medical device regulation was not designed for adaptive AI/ML technologies, which have the potential to adapt and optimize device performance in real-time to continuously improve healthcare for patients.”


That is positive, but it also puts on regulators a particular duty to continuously assess and monitor, as the nature of the medical device and the algorithm within it changes.

The paper sensibly goes on to suggest a completely different way of regulating this kind of dynamic algorithm and type of artificial intelligence incorporated in medical devices. It distinguishes between locked—static—algorithms and dynamic algorithms and states:

“In contrast to a locked algorithm, an adaptive algorithm (e.g., a continuous learning algorithm) changes its behavior using a defined learning process. The algorithm adaptation or changes are implemented such that for a given set of inputs, the output may be different before and after the changes are implemented.”


Those are exactly the points that the noble Lord, Lord Freyberg, made.

The FDA, of course, is one of the great regulators globally. In a sense, it carries on regardless of whatever Administration are in place. So it has a very high reputation. I hope that we are heeding the wise words of the FDA and I very much hope that we are taking on board all the suggestions that the FDA has made for better regulation of algorithms. They are different. I hope that the Minister is not being Canute-like in holding back the thought that new technologies need new treatments in regulatory terms and I am looking forward to what he has to say.