Health and Care Bill

Lord Lansley Excerpts

Committee stage & Lords Hansard - Part 1
Tuesday 11th January 2022 Lords Chamber

Moved by

[Lord Lansley]

4: Clause 3, page 2, line 8, at end insert “and insert “, including in achieving improvements in the outcomes recorded in the NHS Outcomes Framework””

[Lord Lansley (Con)]

My Lords, I am very glad to have this opportunity to contribute to the Committee’s discussions. We turn to the mandate, which noble Lords will recall is the means by which the Secretary of State principally holds NHS England to account for the delivery of its functions and responsibilities in relation to the NHS.

This becomes more important as time goes on, for two reasons: first, because NHS England will incorporate within its own activities more of the functions pertaining to the NHS, particularly the powers and responsibilities of NHS Improvement; secondly, because in the past there was a sense in which some transparency was associated with the bodies across the NHS. NHS Improvement represented the interests of NHS service providers and NHS England represented the interests of the commissioning of services—that is, the public interest and the population health interest. These are to be incorporated in one organisation; that is the essence of the integration that NHS England and NHS bodies have sought to achieve, contrary to the structures of the 2012 legislation. I wish them success with it, but it does not enhance accountability, either to Parliament or the public. Therefore, the mechanisms for accountability must be as clear as we can make them.

As it happens, since 2013 I do not think Secretaries of State or Parliament have used the mandate in the way it was intended they should. On a number of occasions, the Secretary of State has not used the mandate on an annual basis but has run it on, and we therefore have before us—as we will see in many places in this legislation—an acceptance of how practice has developed and that the legislation should come into line with it.

On a number of occasions, I will simply throw up my hands and say, “Fine, if that is how the NHS wants to do things, let us put the legislation into that structure to enable the NHS to do its job in the way it wishes to.” Indeed, I suspect that those outside this House who are looking at the current situation in the NHS are saying, “What is the relevance of us engaging in all this legislative activity at this moment?” Part of the answer is that legislation impacts on the day-to-day activities of people in the NHS much less than they might imagine. Secondly, one of the things we can do sensibly is to say that, even before the pandemic and the additional extreme pressures that the NHS has had to face, it had developed its own way of working, it wants the legislation to fit with that and I think it is probably helpful to the NHS to do that.

There will be other places, and we will come to them later, some of which I mentioned in my Second Reading speech, where I think the Government are looking to go beyond and to change what the NHS has done by way of practical integration, practical implementation and practical decision-making. I think we should resist some of those. I do not think it helps the NHS, at a time of such extreme pressures, for there to be some of these innovations, and maybe we need to call a halt to some of them.

One of the things, however, that the Government are not intending to do is to dispense with the mandate. The mandate is, in my view, more important for the future, for reasons of the importance of the transparency of accountability for the NHS for the performance of its functions. Since we went into recess before Christmas, NHS England and NHS Improvement have published their operational guidance for 2022-23. I think they have actually set out a pretty admirable and comprehensive set of objectives, but only a minority of those objectives are outcomes related. Many of them are, quite understandably under current circumstances, very focused on the volume of activity and the targeting therewith—in particular, for example, that the level of elective activity should rise to 110% of the pre-pandemic level and that diagnostics should increase to 120% of the pre-pandemic level. This is absolutely instrumental if we are to deliver on or get back to remotely the kind of waiting time figures we experienced in the earlier part of the last decade—I might say back to 2012-13, when we reduced waiting times to their lowest level.

The point is that there is a great danger, which we have seen in the way Secretaries of State have structured the mandate in recent years to focus on process, on targets and on volume and to devote insufficient continuing attention to the outcomes that are achieved. I gladly make clear that, while I move this amendment, I do not think it is the way the legislation should be framed. What I am looking for from my noble friend is the Government’s acknowledgement that, even as they focus on waiting times, targets, productivity, volumes and the mechanisms by which the volumes of activity in the NHS can be increased in the years ahead, we must not lose sight of outcomes.

What I mean by that is that we have seen a number of examples in the past of how the pursuit of waiting time targets led to significant problems in terms of hospital-acquired infections, which really threw the NHS off course for more than one or two years. So, in the NHS outcomes framework there is a domain relating to safe care, which I think enables us to focus on things like hospital-acquired infections and continuously to measure the outcomes we are achieving in relation to that.

The same is true in relation to preventing premature mortality. This, happily, is an area where, by focusing on outcomes, we can demonstrate that we are meeting internationally comparative high levels of performance. Of course, that does not relate only to cancer, but it is one of the reasons why we do not have a separate debate for Clause 4. I was prompted to put this amendment forward partly because of Clause 4, however. I am glad that it is in the Bill—it was part of a debate we had more than 15 years ago, when John Baron was with me on the shadow health team in another place—but the point is that we were always focused on one and five-year survival rates for outcomes in relation to cancer. What Clause 4 does is enable us to focus on outcomes in that respect.

--- Later in debate ---

I hope I have been able to give your Lordships some reassurance of our intentions regarding the mandate. I therefore hope that my noble friend will feel comfortable withdrawing his amendment.

[Lord Lansley (Con)]

I am most grateful to my noble friend for that response and to all those who contributed to this short debate. It was a helpful opportunity to reinforce the desirability of the mandate itself being used positively as a mechanism for accountability, particularly where outcomes are concerned.

I entirely take my noble friend’s point that what we are looking for should not be confined to the parameters of the NHS outcomes framework. As time goes on, the possibility of developing what are effectively population health outcomes is exactly where we need to go. My worry is that, if the mandate shifts too much towards population health outcomes, we will be trying to express it in terms of outcomes which the NHS does not control the means of delivering. That goes back to the point the noble Lord, Lord Patel, made earlier about who is responsible for what. As my noble friend said, in essence, the NHS is responsible for delivering the outcomes in relation to healthcare, but the Government are responsible for delivering outcomes in relation to population health, so we cannot confine this to the NHS. The mandate certainly needs to extend into that territory but, in doing so, it should not lose track of continuous improvement in those things that are measured through the NHS outcomes framework, and its development as we go along.

I also take the point about the timeframe. We have learned that we need the NHS to be planning long term, and it is doing that—not least through its development of the 10-year long-term plan. That extends even beyond the Government’s funding commitment, which has a different timeframe. Neither of those are very easily reconciled directly with the annual funding settlement. The mandate could be developed as a very effective way to enable the NHS and the Government to show, in a way that is accountable to public and Parliament, how the plans of the NHS and the funding commitments from the Government can be reconciled into measurable changes, targets, objectives and outcomes in the lifetime of a Parliament, because that is what Ministers will inevitably be looking for. We want the NHS to feel that it has some degree of certainty for the longer term; we want Ministers to feel that they have some degree of accountability and control in the year ahead, or two or three years ahead. That is what the mandate should be used to enable them to do.

My last word on the mandate is: please could Parliament actually scrutinise it? It was always intended that there would be annual debates in this House and the other place on the mandate. There never were. I thought it was shocking that the Government did not devote a day in each House each year to looking at, understanding and scrutinising the mandate as a mechanism for us to look at our most important public service—you can always argue about that, but I think it is—and know what we are trying to achieve in the year ahead, even if the mandate extends further beyond that.

I thank my noble friend, not least for his point on Amendment 10 and his reassurance that Ministers will always explain their reasons for revisions to the mandate and, indeed, that such revisions, as we all agree, should not be too frequent or too detailed; they need to be strategic in their nature. I am glad for his reassurance on that point. With those thoughts, I beg leave to withdraw the amendment.

Amendment 4 withdrawn.

Health and Care Bill

Lord Lansley Excerpts

2nd reading
Tuesday 7th December 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, over the last two years, we have all had cause to be immensely grateful to the National Health Service. NHS staff have responded heroically to the demands of the pandemic, and the service has shown a capacity to innovate, adapt and collaborate. The noble Lord, Lord Stevens of Birmingham, has been at the heart of that, and so we much look forward to his maiden speech today. But we are not out of these woods. There is an immensity of effort yet required, and the Government are right to allocate unprecedented resources to the National Health Service to support the recovery programme.

This Bill enshrines in law an approach that is markedly different from that which has characterised virtually all health legislation in England since the 1980s. That earlier legislation progressively built an NHS based on key principles: autonomous NHS providers held to account by commissioners, who would pay them for the services they actually delivered; patients’ rights to choose a provider; money following the patient; clinical leadership; and, since 2013, an NHS that is operationally independent of politicians but with a series of checks and balances, including a mandated focus on improving clinical outcomes. In some ways, this Bill turns back the clock. Providers’ freedoms are to be limited; the purchaser/provider split is blurred; the NHS is being centralised; payment systems are being delinked from activity; and political direction is being reimposed. We should use debates on this Bill to ask whether this is really the right direction, particularly given the need now for a responsive, productive National Health Service.

One could argue that this Bill reflects a journey that, in truth, started soon after the 2012 Act was passed—and was never truly implemented. We see the Bill establishing integrated care systems, for example, but they have really been around, in one form or another, for six years already, albeit not in statute. Noble Lords considering this legislation should reflect that, much as we labour on the detail of legislation, as the House did a decade ago on my Bill, we should be aware that the NHS may choose simply to ignore it.

The Bill in fact goes beyond the NHS’s own long-term plan. The powers of direction and intervention put in the Bill by the former Secretary of State in Clauses 39 and 40 are not welcome—including to the National Health Service—are a potential political own goal and should be taken out.

Although I see the presentational appeal of repealing Section 75 of the 2012 Act, relating to procurement, virtually the same provisions are contained in Clause 70 of this Bill—highlighting the folly of trying to fix problems in secondary legislation through primary legislation. The slogan is “Collaboration not competition” —ironically, precisely the words that JP Morgan and Rockefeller used when creating vast monopolies.

My legislation was criticised for making the NHS too complex. This Bill takes complexity to a whole new level. We have ICS boards and ICS partnership boards—the latter sitting on top of health and well-being boards. Each ICS is large, so the workaround is to have places within them which map to local authority boundaries. That is just on the commissioner side. On the provider side, we have new provider collaboratives which, in fairness, is where the power in the NHS will lie. The Bill makes no provision for them in terms of transparency, openness or accountability.

The partnership with local government needs to be strengthened. Integration of NHS and social care demands joint planning, so why are the integrated care partnerships and health and well-being boards not made to be the same organisation? We must look also at Clause 54; I do not think hospital foundation trusts should lose their independence.

NHS staff will rightly say that none of this is any good without a clinical workforce, but Health Education England produced the first NHS workforce plan in 2017, and my noble friend referred to the People Plan in 2019. Why, at that time, was Health Education England’s budget cut when the NHS budget was not?

Finally, the Government put Clause 140 in at the last minute, which will mean that if someone has limited assets and must meet heavy care costs, they may end up losing virtually all of their lifetime assets before the cap is applied, but the well-off person would lose only a fraction of their assets. That is not the design of the scheme Andrew Dilnot’s commission recommended to me. I believe many Members in another place want to reconsider this. We should enable them to do so by leaving Clause 140 out of the Bill when we send it back.

As ever, it is our job to revise constructively. I hope that, in doing so, we shall sustain both the independence and accountability of the NHS.

Covid-19 Update

Lord Lansley Excerpts

Monday 29th November 2021 Lords Chamber

[Lord Kamall (Con)]

As the noble Baroness, Lady Watkins, will be aware, our scientific medical advice and the data are constantly reviewed. We are currently conducting thorough tests to review both LFT and PCR efficacy when it comes to the omicron variant. The advice that I have been given is that we must wait for the data and take a cautious, proportionate approach as scientists work urgently to better understand the variant. In terms of the question on more restrictions in terms of where face masks should be worn, the advice at the moment is still on public transport and in shops, and to continue to encourage people to work either from home or in offices, as appropriate.

[Lord Lansley (Con)]

My Lords, in my noble friend’s repeat of the Statement, he said that

“our strategy is to buy ourselves time and strengthen our defences”.

May I ask him about our border controls? Given our testing capacity, would it not make sense for us, for example, to test everybody who comes into our airports at the airport itself so that we have certainty that, where they are positive, we know who they are and are able to conduct the contact tracing required?

[Lord Kamall (Con)]

I thank my noble friend for giving me notice of the question; I appreciate it. The answer that I have been given in response is that we have built a thriving private diagnostic market to meet the demand of the international travellers and day 2 PCR testing for travellers is provided by these private providers. Based on forecast modelling, we are confident that the market has sufficient capacity to meet the rise in demand that omicron may pose.

Public Health England (Dissolution) (Consequential Amendments) Regulations 2021

Lord Lansley Excerpts

Tuesday 9th November 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, it was not my intention to speak in this debate—I wanted to come and listen to it—but I am prompted by a number of contributions just to say one or two things in response to the debate and before my noble friend has a chance to reply. I share with my noble friend Lord Cormack his support for my noble friend in taking on these responsibilities, and nothing I have to say reflects on his role in this. Indeed, I think it has been handed on to the Secretary of State as well, so in a sense we have a new team and I hope they will think about things sometimes in new ways.

I want to make a few, very simple points. The noble Lord, Lord Hunt of Kings Heath, is absolutely right: Public Health England was an executive agency. It worked for the department. In so far as it had operational autonomy, that was not in the legislation; it was a choice made by Ministers. At any stage, as was the case during the Covid crisis, Ministers had all the powers they required in relation both to Public Health England and to the NHS under the emergency legislation.

Let us remember that this House went through the 2012 Act in scrupulous—I might almost say excruciating —detail. It arrived at a conclusion that NHS England should be independent and Public Health England an executive agency. Notwithstanding certain measures put into the legislation to make sure that Public Health England would be more transparent and accountable, that balance was struck not least because I and my colleagues on behalf of the Government said, “We want the NHS to be seen to be independent. We want Ministers to take personal responsibility for public health.”

The noble Lord, Lord Howarth of Newport, referred to one or two things that happened afterwards. I want to share in thanking Duncan Selbie for what he achieved. I want to make it absolutely clear that I understand that Ministers subsequent to the establishment of Public Health England did not give to public health the resources, either for PHE itself or for local government with its responsibilities, that were intended back in 2010-12 under the coalition Government. That did not happen.

Let us remember that, at the beginning of 2020, the King’s Fund produced a report saying that it thought that the public health reforms had worked but they had not been sufficiently funded. Internationally, Public Health England was regarded as being as prepared for a pandemic as virtually any other country in the world. That things fell down needs to be thoroughly examined by an inquiry. An inquiry has not even begun, yet we are already at the point where people have made judgments, reached conclusions and found scapegoats. Heads and deputy heads have rolled.

We are not going about this in the right way. I want Ministers in due course to think again in the light of the report of that inquiry about what constitutes the right mechanism for managing their public health responsibilities. They need an organisation that understands public health in its entirety. How many of us think that the pandemic was unrelated to the extent of non-communicable diseases in this country, to the extent of disparities in this country and to extent of the obesity epidemic that we suffered?

We have so many interconnections between inequalities and public health problems, and our resilience against communicable diseases, that we should never think of managing public health in separate, siloed organisations again, but that is exactly what the Government are doing, without, frankly, having thoroughly understood what happened in in 2020 and 2021. I hope that they will go back and say, “Prevention is not the job of the NHS. Prevention is the job of the Government.” Public Health England was the organisation whose job it was to do that. If it was not strong enough in 2020 to do it, Ministers might look at what they did in the preceding years that might have undermined that role and think carefully about how they should take on the responsibility of building an integrated and fully functioning public health organisation for this country in the future, certainly not simply fragment it.

[Baroness Brinton (LD) [V]]

My Lords, I declare my interest as a vice-president of the Local Government Association.

From the Liberal Democrat Benches, we support the Motion of Regret in the name of the noble Baroness, Lady Merron, and the noble Lord, Lord Cormack and the noble Viscount, Lord Stansgate, are absolutely correct that this House does not like the fact that once again the Government have chosen to use secondary legislation to make major changes to the way the Government manage their business—in this case, public health.

The noble Baroness, Lady Merron, has set out the chaos of a series of announcements from August last year, followed by a variety of procedures and changes when the Government kept getting things wrong. I absolutely support her concerns, and, as have many other speakers, I start from the position that major reorganisations during a global pandemic are unsound and unhelpful, not just to dealing with the pandemic but to the performance of any successor bodies, including the UK Health Security Agency and the Office for Health Promotion and Disparities, with disparity work continuing in NHS England. I echo the comments of the noble Lord, Lord Howarth, and others on the work of all the PHE staff, and Duncan Selbie in particular.

NHS Update

Lord Lansley Excerpts

Thursday 22nd July 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, following our debates on the Medicines and Medical Devices Act earlier this year on an innovative medicines fund, the announcement in this Statement of a ring-fenced £340 million budget for innovative medicines is very welcome. When will those become available, so that clinicians and patients can access this funding? Given that it now takes us beyond cancer drugs and innovations, will there be a focus on those diseases for which there has been no effective treatment?

[Lord Bethell (Con) [V]]

My Lords, I am grateful to my noble friend for highlighting this important development. The cancer drugs fund was a great success, and we are building on it with a substantial investment. The new fund will support patients with any conditions, including those with rare and genetic diseases. Dementia is one area where we are extremely interested in looking at investing further, and I hope that this would be captured, but we are waiting for recommendations from NICE and the data that it will provide before we set the right prioritisations. In terms of the date, I do not have that at my fingertips, but I would be glad to write to my noble friend with the details.

Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) Regulations 2021

Lord Lansley Excerpts

Tuesday 20th July 2021 Lords Chamber

[Baroness Tyler of Enfield (LD) [V]]

My Lords, this is an extremely tricky issue, and I find myself deeply conflicted. On the one hand, I strongly support the principle of mandatory vaccination of care home workers, for reasons I will explain. On the other hand, I think the Government have gone about it in entirely the wrong way. As so often in this pandemic, we are trying to reconcile forces that pull in entirely opposite directions—in this case, the public health need to safeguard some of our most vulnerable citizens, which in my view is overwhelming, pitched against the individual liberties of care home workers.

For me this is deeply personal. My mother is a long-term care home resident and in the first wave of the pandemic, when hospital patients were being transferred to the home without proper testing, there was a significant number of deaths. I need hardly say that this was deeply distressing for my whole family and, I know, many other families up and down the country.

Care homes have a duty of care to their residents, which in my view they are not fulfilling if they do not require care workers who perform close-contact and intimate tasks to be fully vaccinated, unless they have a medical exemption. In my view, anything else would be negligent. Let us never forget the human tragedy this cruel pandemic has wreaked in care homes. Some 20,000 care home residents died in the first wave, accounting for 44% of all excess deaths for that period in England and Wales. We surely owe it to all who died and their families to ensure that care home residents receive every possible protection at a time when cases are rising again with a far more transmissible variant. Today we learn from the latest ONS figures that care home deaths are on the rise too.

Months ago, Professor Chris Whitty expressed the view that front-line health and care workers have what he termed a “professional responsibility” to get vaccinated, to reduce the risk that Covid poses to patients and care home residents. It seems odd that the mandatory hepatitis vaccination for some front-line health workers is hardly, if ever, queried.

I regret that today we are not looking at both NHS and social care workers together. According to the evidence provided to the Secondary Legislation Scrutiny Committee, published only yesterday, take-up of the first dose in the care home workforce stands at 85.6% but with significant variation, as the Minister set out.

It is clear from the two reports of the Secondary Legislation Scrutiny Committee and the debate in the other place on 13 July that this SI is deficient in many respects. The confusing data provided in the Explanatory Memorandum, the lack of an impact assessment—particularly on the workforce implications—and detailed operational guidance not being available until the end of the month are inexcusable. Frankly, I also found it peculiar that the regulations cover a range of tradespeople and other service providers who are unlikely to have close contact with residents. In reality, proper parliamentary scrutiny was pretty much impossible. I totally get that.

I have argued from the outset that far more support was needed to improve vaccine take-up rates among care workers. In early days, slow vaccine take-up was partly due to practical problems, such as vaccinators coming to homes with enough vaccine only for residents, staff being expected to travel to vaccination centres but not given time off or money to get there, and those staff not on duty when vaccinators came missing out. Despite all the efforts made locally to encourage staff to have the vaccine, crucially, the Government should take more proactive steps for carers to be paid for time spent on getting vaccinated, especially if they have to come in when they are not on shift and if they have to take time off because of any short-term reaction to the jab. These things are critically important to low-paid staff, some of whom are on zero-hours contracts.

GPs spending time in care homes talking to staff who are vaccine hesitant has proved highly effective. On top of this, I feel the Government should step in to help with the costs of redeployment and retraining for staff who still refuse to have the vaccine. Without seeing the operational guidance, we do not know whether this will happen.

It is with a heavy heart and after much thought that I am unable to support the amendment in the name of the noble Baroness, Lady Wheeler. I am sympathetic to its intent and broadly support the first three elements, but I cannot support the final element, which says that stronger supporting evidence for requiring staff to be vaccinated is required. The case is clear, and we need to see both more action and more support to ensure that more lives are not lost. However, we need to see the right action.

I plead with the Government, even at this late stage, to think again and to provide the help and support I have outlined above. I also feel that it sends out the wrong message to the public, who will not be following the minutiae of parliamentary procedures and impact assessments and the like. The message will simply be that we do not support the principle of mandatory vaccine for care workers other than those with the medical exemption, which I do, and strongly. This is the right policy but, sadly, the Government have gone about it in entirely the wrong way. It should also apply to NHS workers and it was wrong to exclude them. However, two wrongs emphatically do not make a right.

[Lord Lansley (Con)]

My Lords, I am very glad to follow the noble Baroness, Lady Tyler of Enfield. Like her, I would not be in a position to be able to support the amendment to the Motion. I support this statutory instrument but, I have to say, with some reluctance—and it is not simply because of the procedural issues. It is a step we should take only in a health emergency. I will come back to that point before I conclude.

I am grateful to my noble friend, who explained the SI with his customary clarity, but we are especially grateful to the Secondary Legislation Scrutiny Committee, whose painstaking work has illustrated many of the issues, including those I want briefly to refer to. I am looking for my noble friend in responding to this debate to give one explanation and two sets of assurances.

The explanation is because I simply do not understand why care homes have been brought forward and legislated for in this way where other settings have not been. I cannot understand the difference between a care worker going into a domiciliary care setting with a vulnerable person and how that differs from a care worker in a residential care home. I cannot understand how the vaccination of a residential care worker is different from the vaccination of a healthcare worker in a geriatric ward in a hospital. Why are these things different? If the Government are going to move forward on this, they should have moved forward on all these settings together and should have had the clear argument presented rather than what appears to be a piecemeal argument. I hope that my noble friend will explain why the Government have proceeded in this piecemeal fashion with a further consultation to come, which may lead to different conclusions even at the margin for other settings and for care homes, which will create unnecessary confusion.

Secondly, I am looking for an assurance about support for the care home sector. My noble friend said that the statement of impact—which I found on the government website but of course not published alongside the legislation—says that the Government’s central estimate is 40,000 potential losses of staff. This is in a sector where Skills for Care reported 112,000 staff vacancies in the autumn of last year and where we know that there is a dependence on workers from overseas, some of whom have gone back home and not returned. The sector needs help. The impact statement says that recruitment on average costs £2,500, which is £100 million for the sector in consequence of this measure. That is before you begin to look for the other support it needs from the healthcare system, its general practice colleagues, and in dealing with the insurance sector and others. I hope my noble friend will be able to say that the Government will add significantly—at least that £100 million—to the infection control fund, which is £1.1 billion, and do so in close consultation with the care home sector to give it the support that it needs.

Thirdly, and finally, the point of reassurance I am looking for is that I expected, having discussed this with Ministers, that this statutory instrument would be brought forward with a sunset clause. That is transparently something that should apply during the emergency. It would be reasonable if the Government had said, “This time next year, we should be deciding whether legislation of this kind should be renewed, and a sunset clause would enable that to happen.” I have no confidence that a review, as Regulation 7 says, means that if the review concluded that legislation in this form was not needed, it would not be retained. I am sorry, but I am afraid that from the parliamentary point of view, that is unacceptable. Therefore I am looking for my noble friend to make it absolutely clear that if Ministers conclude next year that the review says that this legislation is no longer needed, they will ensure that it is repealed.

Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021

Lord Lansley Excerpts

Monday 12th July 2021 Grand Committee

[Lord Lansley (Con)]

My Lords, I am grateful to my noble friend the Minister for his introduction to these regulations. I agree with the noble Lord, Lord Rooker: my noble friend has acquired a rhetorical flourish or two today.

We can see the powers that we debated on the Medicines and Medical Devices Act coming into use already. The powers in Section 15 are being used for this purpose, but my noble friend will of course recall that Section 16 related to the criteria, including the effect that any regulations made would have on the life sciences industry in the UK. The Explanatory Memorandum argues persuasively that this validation process will increase the resilience of the supply chain and may even encourage domestic suppliers. It also refers to the discount available to SMEs, which is welcome. But paragraph 12.8 of the Explanatory Memorandum says that an impact assessment would be published in time for the parliamentary debate. I could not find one yesterday or today. Will my noble friend say where it is and whether it confirms that it is the Government’s clear view that the life sciences industry and SME interests are fully protected?

There is a clear case for validation of these tests, given the reported failure rates of tests submitted for public procurement, to which my noble friend referred. We need to use lateral flow tests to support the return to school in the autumn, to enable employers to bring their staff back to their workplaces, and to counter outbreaks—in particular with large-scale surge testing—when we have achieved a lower prevalence again, which I hope will be in the late summer.

Studies including the Cochrane review, published in April, suggest that lateral flow tests will reliably confirm that someone without Covid is negative; in that sense, they have very high specificity. Where their sensitivity is concerned, they will confirm infection in someone with symptoms in an average of 72% of cases, but will on average identify the infection in asymptomatic cases only 58% of the time. Those results will vary according to the location and experience of the tester—where it is done and by whom. We need these tests to work at home and not just in the hands of healthcare professionals.

I support the regulations but I have three issues to raise. First, the tests procured by the Government will not be subject to validation because that would essentially be duplicatory, as the test approval is based on that same procurement process. But that procurement process has been used by the Government principally for the procurement of the Innova tests, which, as the noble Lord, Lord Rooker, made clear, are essentially manufactured by Xiamen Biotime Biotechnology in China. The Government, of course, had an intermediary company—Disruptive Nanotechnology, in Northampton—which, as far as I can see, was effectively a non-trading company at the end of December 2019. It is Innova Medical Group that is essentially the intermediary.

Innova is a Californian company. It is reported that it has sold 380 million tests to the Government. But on 10 June, the Food and Drug Administration issued a safety communication that the Innova rapid antigen tests should be withdrawn. Indeed, its communication suggested that the people who had them should simply throw them away. The question I come to is this: if we are confident in the Innova tests, what has been the nature of the discussions we have had with the Food and Drug Administration? My understanding is that, essentially, the Food and Drug Administration took the view that Innova was advertising the tests for use with asymptomatic people, but that they were authorised for use with those who have symptoms and that their sensitivity is greater for those with symptoms. Is that why the FDA issued its class I recall on these tests? That being the case, why did my noble friend say when he introduced the regulations that it is really important that we have tests that work for those who are asymptomatic? These tests are not sufficiently specific for those who are asymptomatic.

I know that it is a legal case, so my noble friend might hide behind his inability to speak about it, but why has Mologic, a Bedford company that has a track record, found it necessary to sue the Government in relation to their validation processes for the public procurement? What does that tell us about the validation they propose to use for this purpose?

I have two very quick other points. To put at rest the mind of the noble Lord, Lord Rooker, could my noble friend update us on the plans announced last month for Innova and Sharp packaging to build a factory in Caerphilly to produce up to a million tests a day, starting in July—this month? It is absolutely right that we should have leading medical technology companies in this country and manufacturing supply alongside them.

Thirdly, to further endorse what the noble Lord, Lord Rooker, said, could my noble friend explain what the Government’s intention is on charging for tests, particularly for employers, who will want to institute testing regimes to bring their staff back into their premises and to protect the public and their customers while doing so? They have had 18 months, in many cases, during which they have lost revenues. Should we really expect them to meet this further cost at this stage? Their taxes will sustain us in the future, but should we not now support them to get back to work? I would be grateful for my noble friend’s response.

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

The noble Baroness, Lady Brinton, has withdrawn, so I call the noble Lord, Lord Scriven, in her place.

Medical Devices (Northern Ireland Protocol) Regulations 2021

Lord Lansley Excerpts

Monday 12th July 2021 Grand Committee

[Lord Lansley (Con)]

My Lords, I am grateful to my noble friend the Minister for his clear introduction to these regulations. I want to take the opportunity to comment on just one aspect of these arrangements: the processes for a conformity assessment on medical devices placed on the market in Northern Ireland.

A European conformity assessment, a CE mark, is to continue to be recognised in the Great Britain market until 30 June 2023. Likewise, the certificates issued by EU notified bodies will continue to be recognised until that date. It seems to me that, if one is a Northern Ireland-based manufacturer of a medical device—the Explanatory Memorandum estimates that there are some 300 such businesses—for the next two years the CE mark should be a sufficient basis for placing a product on the market, whether in the EU, Northern Ireland or Great Britain. I would be grateful if my noble friend were in a position to confirm what I say or correct me.

If a Great Britain manufacturer is meeting EU requirements then, from 2023, it will require a UK conformity assessment, but this in itself will not enable its product to be placed on the market in Northern Ireland—hence the references in these regulations to the “UK(NI) indication”, which appears to become of greater significance after 1 July 2023. From that time onwards, British manufacturers will be required to adopt dual marking and conformity assessment through two systems, with the attendant cost and complexity. Obviously, the same is true for non-EU third-country suppliers.

At the heart of this problem is the failure of the trade and co-operation agreement to provide for mutual recognition of conformity assessments, given the simple fact that, as my noble friend Lord Empey adverted to, our MHRA undertook 40% of the most significant assessments in the EU. We do not have divergent technical standards; what we have, unfortunately, are divergent political priorities. I personally do not blame Theresa May’s negotiators for our failure to secure that mutual recognition.

One option now would be to roll forward our recognition of European conformity assessments—the CE marking—beyond 2023. Frankly, I do not expect that to happen, because it would undermine the role of the MHRA and British notified bodies, but can my noble friend explain what the position will be for Northern Ireland manufacturers post 1 July 2023? Given the principle of unfettered access to the UK market, will they be able to sell in Britain on the basis of their CE mark or will they require dual marking? This regulation makes provision for the UK(NI) indication, which is useful for UK manufacturers using a previous EU approval and for British devices to access the Northern Ireland market, but it seems to me no more than a face-saving approach to cover the harsh reality that we are going to put our highly successful medical devices sector through significant additional cost, disruption and bureaucracy.

Covid-19 Update

Lord Lansley Excerpts

Tuesday 6th July 2021 Lords Chamber

[Lord Lansley (Con)]

My Lords, I support the move from legislation to guidance in relation to the measures in the Statement. But does my noble friend agree that there is a case for continuing regulation of the circumstances where somebody is the contact of somebody who has tested positive? Can he update the House on what the Government are proposing regarding relaxing some of the restrictions for those who are contacts of positive tests?

[Lord Bethell (Con)]

My noble friend puts it very well. Clearly, with the infection rates rising but with a very large proportion of the country vaccinated, it is worth reviewing this. As the Secretary of State said in his Statement earlier this afternoon, from 16 August the Government intend to exempt people who have been fully vaccinated from the requirement to self-isolate if they are a contact of a positive case, with a similar exemption for under-18s. Anyone who tests positive will still need to self-isolate regardless of their vaccination status. Symptomatic testing will continue to be available. This is a proportionate direction, given the state that we are in.

Health Security (EU Exit) Regulations 2021

Lord Lansley Excerpts

Monday 5th July 2021 Grand Committee

[Lord Lansley (Con) [V]]

My Lords, I am pleased to contribute to this short debate. I thank my noble friend the Minister for introducing the regulations, which, as the noble Lord, Lord Hunt of Kings Heath, quite rightly said, are self-evidently necessary in these circumstances. I have no reservations about introducing them but I want to take this opportunity to explore a number of issues, including how my noble friend anticipates our relationship with the European Union developing in future.

First, the question of where the common frameworks are concerned inside the United Kingdom is fairly straightforward. However, I am not entirely sure how the UK health protection committee will coincide with, or work directly with, the four Chief Medical Officers; perhaps my noble friend can tell me. Certainly in England, the Chief Medical Officer appears to have a different future role in relation to health security than was formerly the case for his predecessors.

So far as the relationship with the European Union is concerned, my noble friend felt that the TCA created a full process for co-ordination. I am afraid I do not agree with him. I think the TCA creates a bare-bones relationship with the European Union for the future. I am not even sure that what is in the TCA has yet been in any sense implemented, since it includes a memorandum of understanding between us and the European Centre for Disease Prevention and Control, and I see no evidence of that being negotiated. Perhaps my noble friend can tell me whether that is the case. One has recently been concluded between the ECDC and Mexico, but not with us.

When one looks at the ECDC, which was established in the wake of SARS in 2004 to enable the European Union to be prepared for a future pandemic, I am afraid one is not impressed. It retreated from its media functions with anything other than national authorities and health professionals—it retreated from public communication—and it needs radically to change its approach. Indeed, as an organisation, it is hamstrung by the simple fact that under the Treaty on the Functioning of the European Union it is dependent on the activities of national authorities. It complements the work of national authorities but in no sense co-ordinates or controls them. For example, by 3 April last year, four European Union member states had failed to supply the ECDC with the necessary data for surveillance purposes. So unless and until the ECDC is in a position to inspect and secure data surveillance in all EU member states, I am not sure that it has the necessary powers and control.

The European Commission, albeit producing reports explaining how well it has done, freely acknowledges this in the way in which it is approaching the development of a European health union, as the noble Lord, Lord Hunt of Kings Heath, suggested. We may no sooner have this in force later this year, and start to create a relationship between the health security committee and the ECDC, than we find that the European Union has created a health emergency preparedness and response authority, which it anticipates should be operational in 2022. There may be a European Union chief epidemiological officer. There may be a major manoeuvre on the part of the European Commission, proposing to legislate for a European health union. It may well move from competence being entirely for national authorities on major cross-border health threats to an EU competence shared with national authorities. That may make a considerable difference. However, when it comes to us co-operating with the European Union on cross-border health threats, it means that we have to be prepared for much more substantial activity on its part and a much more complex relationship with a range of European Union actors.

I shall mention one final thing. In all this, nobody appears to have referred to the role of the World Health Organization’s regional office for Europe. I am reminded that there are 27 member states of the European Union, but 53 participating states—at the last count, but I think it might have gone up to 55—in the World Health Organization’s region for Europe. A number of those states, such as us, Switzerland, those in the western Balkans and so on, will be integral in responding to a cross-border health threat of the kind we have experienced during the pandemic. If, as we wish, and I think the European Union wishes, there is to be enhanced global health security, there is no alternative to us reforming the World Health Organization and, in the process, vesting greater potential in its regional structures. Those have been poor in the past but could be much more effective in future. They take responsibility in relation to all the countries likely to be affected rather than, as in the case of the European Union, only just over half of them in Europe. I hope my noble friend will be able to say something about the Government’s plans for strengthening the WHO in Europe.