Medicines and Medical Devices Bill

Lord Bethell Excerpts

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

Moved by

[Lord Bethell]

1: Before Clause 1, insert the following new Clause—
“PART A1THE COMMISSIONER FOR PATIENT SAFETYEstablishment and core duties etc
(1) The Secretary of State must appoint a Commissioner for Patient Safety (referred to in this Part as “the Commissioner”) to exercise the functions set out in this Part in relation to England.(2) The Commissioner’s core duties are to—(a) promote the safety of patients with regard to the use of medicines and medical devices, and(b) promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.(3) The Commissioner is not to be regarded as the servant or agent of the Crown or as enjoying any status, immunity or privilege of the Crown.(4) Schedule (Further provision about the Commissioner for Patient Safety) makes further provision about the Commissioner.”Member’s explanatory statement
This amendment inserts a new Clause which provides for the creation and core duties of a Commissioner for Patient Safety in relation to medicines and medical devices in England. The new Clause and the Schedule which it introduces would form a new Part, to appear before Part 1.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell)]

My Lords, patient safety is very much at the heart of the Bill, and while we have an enormous amount to get through this afternoon, I beg the Chamber’s forbearance if I talk in some detail about this extremely important amendment. Patient safety is the golden thread that runs through this entire Bill. Safety has been our guiding force in amendments that have made it to the Bill, from the changes to decision-making on regulatory change and the new safety lock amendment—which we will debate later—to the enforcement powers for medical devices to make clearer what the MHRA can do to take action, through to the medical devices information system.

The Government have heard the calls, including the strong cross-party support, to establish an independent patient safety commissioner for the health service in England. Of course, this was the centrepiece recommendation of the Independent Medicines and Medical Devices Safety Review helmed by my noble friend Lady Cumberlege, to whom I pay profound tribute for her tireless championing on behalf of patients. I am delighted that Amendment 1 in my name—with which it is convenient to debate Amendments 54, 65, 70 to 72, 74, 86, 87, 91, 95 and 97—delivered upon that recommendation. These amendments provide for an independent advocate to champion the safety of patients. The patient safety commissioner will promote their interests and those of other members of the public in relation to the safety of medicines and medical devices.

We acknowledge that the patient’s voice can advance safe care and system improvements but that it needs to be strengthened, as explained in my noble friend’s review published six months ago. Listening to patients is central to preventing the kinds of issues which that review brought so clearly into focus. If we do not strive to listen to patients, their families and to staff, we limit our ability to learn from mistakes, be innovative and continually improve. I pay testament to the extensive listening and the passionate advocating by my noble friend, her supporters and all patient groups.

Patient safety is a system-wide concern. It cannot be tackled by a single individual but needs to be rooted in all the branches of our health system. Good progress has been made: for example, we are improving system-wide learning through measures such as the Healthcare Safety Investigation Branch and the implementation of the 2019 NHS Patient Safety Strategy with our National Director of Patient Safety, Dr Aidan Fowler, in charge. That strategy has been listening to patients.

Staff are also encouraged and protected to speak up if they have concerns about anything they believe is harming the services their organisations deliver or commission. They are supported by the NHS People Plan, which envisages a health service that is compassionate and inclusive, not hierarchical, and where staff are listened to. The Government’s emphasis on patient safety will also be reinforced by the establishment of a new patient safety programme board. The board will take an overview—with pace and rigour—of measures and actions across the health system to improve patient safety.

The Government fully support sharpening our focus on the safety of NHS-funded services to patients and the public. We accept that the patient safety system needs to get better at identifying issues and listening to patients’ experiences of avoidable harm. Better co-ordination across and between regulators and other oversight bodies is also needed.

A patient safety commissioner will help us to champion the views of people who have been harmed by treatments provided by the health service. He or she would reinforce a culture of humility, openness and learning. The role is essentially about prioritising the insights of patients as a vital source of learning.

The Government’s amendment puts this new part of the Bill first. Amendment 1 provides for the appointment by the Secretary of State of a patient safety commissioner who is an independent statutory officeholder funded by the Department of Health and Social Care. It sets out the commissioner’s core duties, which are to promote both the safety of patients and the importance of ensuring that they are heard.

Patient engagement will be integral to the role of the commissioner. Proposed new Schedule A1 outlines the ways in which the commissioner must inform, consult and involve patients. This will ensure that patients’ concerns are being heard and that the work of the commissioner has focus and relevance for the people he or she is being set up to serve.

We have reflected carefully on the patient safety commissioner model set out by my noble friend’s comprehensive report. We agree on the importance of the commissioner’s role; it is a critical new part of the map of patient safety. But there are other areas of significant importance to the Government. The commissioner is one part of the whole system—the fundamental change that it required to tackle unsafe care and empower patients. A step change is required in how the health service transforms itself in a joined-up way to put patient safety at its core. Significantly, the introduction of the commissioner should not create overlap or confusion within that health service architecture, thereby reducing the potential to deliver patient safety improvements for patients. Indeed, my noble friend’s report rightly made it clear that the duplication of the roles of other regulatory bodies should be avoided.

In view of this, the patient safety commissioner will not act as an ombudsman. He or she will not carry out functions in pursuit of specific cases. But they can consider individual cases in their role as an overarching advocate for all patients and of making thematic and systemic recommendations. These areas are where we believe the commissioner can have greatest impact.

We have also given the patient safety commissioner deliberately intrusive powers, as called for by my noble friend Lady Cumberlege. He or she will be empowered to request and share information from relevant public authorities or a “relevant person”, meaning anyone providing health care, in relation to medicines and medical devices in England. The commissioner’s ambit will cover both the public and the independent sector.

Where my noble friend and I differ is on the process of the appointment and sponsorship of the commissioner. The patient safety commissioner will be appointed by the Secretary of State for Health and Social Care and funded by the Department of Health and Social Care. It is absolutely right that this should be the case. For example, the Secretary of State is able to initiate action on reports and understands, and has strategic oversight of, the system the commissioner is looking at.

Some noble Lords have expressed concerns about how such a commissioner might maintain their independence, but I believe that such concerns are unfounded. I am encouraged by the precedent of the Office of the Children’s Commissioner, which drew praise from several noble Lords in Grand Committee for its independence. As noble Lords know, the Children’s Commissioner is sponsored by the Department for Education and guards its independence very well. The Victims’ Commissioner does exactly the same and is sponsored by the Ministry of Justice.

It is critical—that is agreed—that the patient safety commissioner is able to speak out without fear or favour. He or she must have the powers and functions to act independently to maximise their impact and confidence. That is absolutely the case here. It is also critical that the right calibre individual with a strong voice for patients is appointed to the role. I do not think any such person would accept such a role if they felt they would in any way be constrained in that role. Nor do I think they would remain silent. Furthermore, we would expect the Secretary of State to work with the commissioner to establish how they will safe- guard and secure the commissioner’s independence. Independence is not static but an active objective, which we would expect the patient safety commissioner to be prepared to approach continuously.

The commissioner will have the power to make reports to both the public sector and independent sector, and to the Department of Health and Social Care if they so wish. Those reports are entirely independent. There is no intention—and indeed no restriction—that would allow for the Secretary of State to edit those reports. As an independent public appointee, the commissioner will also be subject to the scrutiny of Parliament, including through the Health and Social Care Select Committee.

The powers in the Bill are accompanied by a regulation-making power about the terms of office of the patient safety commissioner, the appointment of staff, and other operational matters. But while this power is exercised by the Secretary of State, we are not proposing that the Secretary of State would have any power over the commissioner regarding the fulfilment of his or her functions. However, it is right that the detail is left to regulations so that we can publicly consult on this, as we are obliged to do so under Clause 45. It is important that we get the details right. That is also why the regulations will be subject to the draft affirmative procedure.

Other amendments make minor changes to ensure that the patient safety commissioner clauses work well with the rest of the Bill.

From the First Do No Harm report by my noble friend Lady Cumberlege, to earlier, well-known inquiries and investigations, we have heard numerous harrowing stories with terrible examples of how patients have been let down badly by our most loved institutions. As noble Lords have said, now is the time to act. The Government have listened to the impassioned and compelling arguments from all sides, and I thank my esteemed colleagues for their help in shaping this amendment.

We have no doubt that restoring patient trust will be at the heart of the patient safety commissioner’s role and that he or she will advance patient safety. Our commitment to amplifying and acting on the voices of patients in our health service is paramount. To that end, I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, I thank the Minister for his huge support throughout this whole process—all the times we have had to meet and I have met with his officials. I also thank him for the way in which he has so comprehensively introduced his amendment today. To be honest—“O ye of little faith!”—there were times when I thought the patient safety commissioner would not see the light of day. However, I underestimated my noble friend and thank him for agreeing to the concept and for bringing it to fruition with his officials.

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[Baroness Thornton (Lab)]

My Lords, I can only join in with the congratulations that everybody has expressed in this debate today. I congratulate of course the noble Baroness, Lady Cumberlege, and support her—as we have from these Benches throughout. I also congratulate and thank the Minister, the noble Baroness, Lady Penn, and also somebody who I do not think has been mentioned but I do remember sitting giving his wisdom in the many discussions we have had, who is of course the noble Earl, Lord Howe. I think the team were very wise indeed to have him sitting with them.

I am not going to say very much because I think we are there with this. Most of the questions that needed to be asked have been asked: on speed, independence, resourcing and powers, and on the issue of “relevant person”, which several noble Lords mentioned. These are the key issues.

One issue that has not been mentioned—here I thank the PSA for its brief—is the need to ensure that there is no reduction in public protection in any other areas of government policy, and that the remit of the role should link closely with the work of the other bodies involved in patient safety.

Finally, I have to say that I agree with the noble and learned Lord, Lord Mackay of Clashfern, that there has to be a four-country element in this. As the role is intended to cover only England, there should be consideration of how the link with equivalent or complementary mechanisms will work in the other countries of the UK. Otherwise, we might find ourselves with a dissonance here, which will not be in patients’ interests.

[Lord Bethell (Con)]

My Lords, I will save my Hollywood thank-yous for the end of the process, but profound thanks will need to be said. I want to say specific thanks to those who have spoken in the debate on these amendments. There have been a large number of very thoughtful comments. The noble Baroness, Lady Thornton, and my noble and learned friend Lord Mackay both mentioned four nations and devolution. The noble Baroness, Lady Bennett, spoke on gender, my noble friend Lord O’Shaughnessy on industry advocacy, and the noble Baroness, Lady Ritchie, on Northern Ireland. It is a very long list, and I cannot address every contribution. What I will do instead is address what I think have been the key points in the debate on these very important amendments.

Amendment 65 was tabled by my noble friend Lady Cumberlege before the Government’s own. I am extremely grateful to her and her team, who have written to me expressing their thoughts. The government amendment would not have been possible without her continued engagement and that of other noble Lords whose experience and knowledge have been essential in shaping the Government’s thinking. Although there are differences between our amendments, we are agreed on the fundamental point that we must create a patient safety commissioner in order to give the voice of patients its rightful prominence. My noble friend Lord O’Shaughnessy has made that point extremely clearly and effectively.

More broadly, I hope that the amendment in my name assures my noble friend Lady Cumberlege and the House of the seriousness with which the Government takes the report First Do No Harm. The Government will continue to review this report. We made a Written Ministerial Statement on the report and its recommendations yesterday, and will respond to the whole report shortly.

A patient safety commissioner, as proposed in Amendment 65, would promote the interests of patients and other members of the public in relation to the safety of medicines and medical devices. The Government entirely agree that listening to patients is essential to preventing the sorts of issues highlighted in the report. On this, our visions for the patient safety commissioner are as one.

However, Amendment 65 in the name of my noble friend Lady Cumberlege differs in specific ways. Her proposed new subsection (2) provides that the Cabinet Office would host and fund the patient safety commissioner. My noble friend has argued here and in Committee—and, indeed, in her report—that this would be necessary to safeguard the independence of the commissioner. I simply do not agree. It is common practice for commissioners to be sponsored by the government department with relevant policy responsibility, and it is entirely unclear to me what the benefit of sponsorship elsewhere would be. The process of public appointments is set out clearly; there is no question of undue influence by the sponsoring Secretary of State. The process is there—in fact, it is public. Nor does the identity of the sponsoring department amend or change the powers and functions of the commissioner; it is simply how the body is supported.

There are also differences in the way in which my noble friend’s intention is executed. In her report, she was clear that working with other bodies was necessary and, as I would hope, obvious as part of any commissioner’s remit. However, Amendment 65 is unclear as to how the commissioner would interact with other regulatory bodies. For example, proposed new subsection (5)(e) would allow the commissioner to receive direct reports from patients and any other persons, including regulators and the public. However, the CQC, the Parliamentary and Health Service Ombudsman and the MHRA, among others, are all open to receiving direct reports from patients and the public. They have a responsibility to listen to complainants. These bodies also have their own routes for reporting. For example, as we know from the vaccines rollout, adverse incidents relating to medicines and medical devices are reported through the MHRA’s yellow card scheme.

Without differentiation between taking receipt of direct reports to further a broader investigation and acting as an ombudsman, Amendment 65 might create a body overwhelmed by patient reporting and investigating individual cases. The noble Lords, Lord Patel and Lord Hunt, both referred to past agencies here, but where the best route to resolution sits elsewhere. The report itself said that the commissioner should not investigate individual cases, yet this boundary is absent from the amendment.

Proposed new subsection (7) enables the commissioner to require information from public bodies and others for the purposes of producing and laying before Parliament reports regarding patient safety, but “other” would extend to private individuals—a very expansive group indeed. The amendment tabled by my noble friend provides for the commissioner to make reports only to the Secretary of State and Parliament, and not to a range of bodies as in the government amendment. Nor does my noble friend’s amendment provide for what would happen if these individuals did not respond.

“Relevant person” is a broad definition. I am confident that it will enable the commissioner to engage with the organisations necessary to fulfil their functions effectively. In addition, proposed new paragraph 3(1)(b) of Schedule A1 would enable the commissioner to receive information from and consult

“any other person the Commissioner thinks appropriate”.

This provides the commissioner with all the relevant tools necessary. A vital difference between my amendment and the proposals of my noble friend is that, in mine, provisions are made for the patient safety commissioner to make reports and recommendations to relevant public authorities or persons, and for that authority or person to have a duty to respond to these; I think that is vital.

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[Baroness Cumberlege (Con) [V]]

My Lords, I want to say one or two things very quickly. I thank those who have spoken; it has meant such a lot to me. The noble Baroness, Lady Jolly, and the noble Lords, Lord Patel and Lord Hunt, have been there since the very beginning of this journey.

I say to the Minister, as I should have said at the very beginning, that I will withdraw my amendment. I have no wish to take it further. I do think that the Cabinet Office would have provided us with more independence, but my noble friend the Minister said at the very beginning that this was a red line and it was no good my pursuing it. I took that hint and I have not argued it anywhere. Hearing the Minister talk about independence today—getting it on the record—has been really important. However, as the noble Lord, Lord Lansley, said, of course influence matters as well, and I take that.

I will say a very quick word about the timetable, which is critical. In our recommendations we wanted to set up a task force to implement this under the aegis of the Department of Health and Social Care. That has been rejected by Ministers. That is a tremendous pity. Noble Peers are concerned about the timetable; so am I.

It has been said that this has been very quick. No, it has not. Those of us who have run companies know what “quick” means: if your company is to survive you have to act very quickly. This is not quick. I will put pressure on through other means, particularly the all-party group, to get this implemented as soon as possible, because people are suffering. People are in dire straits and we have to stop this awful damage that is being done to lives. The quicker we can do this, the better. I am sure my noble friend will agree with that.

I know when I am beaten, but I also know what needs to be done. I do not want to go through the point of view of the Cabinet Office, but it is absolutely critical that this appointment is made speedily, because people are suffering and we should avoid that if at all possible. I believe that the patient safety commissioner will grasp this issue and ensure safety, which, as my noble friend the Minister said, has run through the Bill. I thank him for that, but it will not happen until this appointment is made. I am afraid that I will press very strongly on that.

I thank all noble Lords for taking part. I wish I could go through this in detail, but it is not my remit to do so. I thank noble Lords so much for their support.

[Lord Bethell (Con)]

I thank my noble friend for her very kind and generous words, and for making it clear that she will not move her amendment. I reassure all noble Lords that their words are on record and will have a bearing and influence on the development of the patient safety commissioner as it is rolled out.

My noble friend’s question was about timing and speed. I hear her admonishments loud and clear. She knows that once we have committed to something we will deliver it. I ask for her forbearance. There is a global pandemic on. I cannot guarantee that this is the number one priority because we need to do the vaccine and we have to get Britain back on its feet. Those are distractions that I cannot hide from the House, but I reassure my noble friend and all those involved in the debate that a commitment has been made very clearly and we are now moving to deliver it.

Amendment 1 agreed.

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[Baroness Jolly (LD) [V]]

As the noble Lord, Lord Hunt of Kings Heath, and others have said, these amendments relate to sunset provisions and consolidated legislation. As we have already heard, the Bill is largely a skeleton Bill and allows the Secretary of State or a relevant authority to make legislation by statutory instrument on policy issues relating to human medicines, veterinary medicines and medical devices. Can the Minister confirm whether the SIs referred to will come before the House? Will he also confirm that the SIs we see will live up to the expectations of the noble Lord, Lord Blencathra, and his committee?

It is important that there is a limit on how long the delegated powers should last. The amendments in the name of the noble Baroness, Lady Thornton, would mean that, after the suggested three years have elapsed, the policy objectives of the Government would be clearer and they could return with primary legislation. The amendments in the name of the noble Lord, Lord Patel, would require the Government to publish the consolidated primary legislation in draft form. We support these measures but, for the intervening period, we believe that the powers should be subject to the additional scrutiny required by my noble friend Lord Sharkey’s amendments in the next group.

[Lord Bethell (Con)]

My Lords, I thank noble Lords for an extremely powerful session on these amendments. I confess that I completely share the aspiration voiced by many noble Lords about Britain having the best possible legislation on life sciences in the world. As the Life Sciences Minister, that is a natural ambition, but it is also a real possibility, and it is what we are working towards at the department, and through the Bill. But I have severe reservations about whether this approach is the right mechanism, and I would like to address those directly.

The noble Baroness, Lady Thornton, has tabled Amendment 2, which relates to the sunset clause, and with this amendment it would be convenient to speak to Amendments 26, 27, 39, 40 and 63. I will come to Amendment 2 shortly but, first, I cannot say that Amendment 26 is a big surprise. The noble Lord, Lord Patel, who authored it, indicated as much when he and other noble Lords discussed these matters after the excellent debate in Grand Committee. The intent of his amendment is to require the Government to publish draft legislation within three years—legislation that consolidates medicines and medical devices regulation. I understand the arguments made during Committee, and again here today, that the regulation could benefit from clarification and those arguments made on how secondary legislation could be used. The amendments in the name of the noble Baroness, Lady Thornton, go further. They would append a sunset clause after three years—I repeat, three years—requiring not draft legislation but passed legislation.

I start by addressing the timing put forward. The noble Lord, Lord Patel, asks for the Government to publish draft legislation within three years of Royal Assent. I assume that he intends this consolidation effort to include changes made under the delegated powers in the Bill, including policy that may be made to, for example, take forward a national falsified medicines scheme. The noble Baroness’s amendment would have the delegated powers lapse entirely, leaving us without the ability to amend or supplement the regulatory regimes at that point. In reality, three years between Royal Assent and draft legislation ready for publication that consolidates the existing legislation and includes any changes made under the Bill is just not long enough. Each change to the regulatory regimes will take time. Public consultation must be conducted and amending regulations must be laid, debated and so on. We do not intend—in fact, it would not be possible—to front-load policy changes into the first half of 2021, let alone 2021 at all.

Noble Lords have spoken to the importance of consultation. I say it would not just be the Government front-loading legislation; it would be about asking the affected sectors to engage with a lot of consultation very quickly and in parallel. That does not seem the right way to go about it at all. It inevitably means that the sorts of exciting policy changes that support our life sciences sector and protect patients will take an enormous amount of time to stand up. Developing and consulting on policy proposals that require legislative changes takes time, as does the drafting of any proposed legislation. Before getting to the point of drafting the legislation and so on, you need to have made an assessment of what it would be appropriate to consolidate —and that takes time.

The Human Medicines Regulations 2012 were the product of a consolidation exercise that required extensive consultation. Consultations were run while explanatory documents setting out changes so far, and so on, were all prepared before the regulations were made. Let me be clear on the timescale involved in that exercise. A concept paper was issued by the MHRA in 2009. There was an expectation that consolidating human medicines regulations, including looking at the Medicines Act 1968, would take around three years to complete. That concept paper was put out to consultation; a response was published and further consultation took place in 2010.

The first complete draft of the regulations was published in August 2010 and a number of specific consultations also run in that year. A further consultation, following the consultation on the draft regulations of August, was run between October 2011 and January 2012. Three years is the time it takes to do the comprehensive exercise that the noble Lord, Lord Patel, alludes to in his amendment, and that exercise did not involve making up new primary legislation in the first place: it resulted in the Human Medicines Regulations 2012. The noble Lord has extended his amendments to medical devices and veterinary medicines as well.

The noble Lord cannot mean us to start a review the day after this Act is given Royal Assent, with the intention of bringing forward proposals within three years. There would be no legislation made under the Act to assess. I cannot see an exercise of seeing what to consolidate and then preparing the drafting taking less than a year altogether. In fact, it would more likely take much longer if the consolidation is intended to be as far-reaching as the noble Lord and others have very powerfully indicated. Taken together, the noble Lord’s amendments would mean that the process would need to start by 2022, but not all the legislative change to be brought forward under the Bill’s powers would yet be made and in effect.

I anticipate that a consolidation exercise as proposed by the noble Lord would wish to consider the practical effects and operation of such a complex and comprehensive body of legislation. In order to do that, we would need time for the secondary legislation to be made to deliver policy. Industry then has to comply with revised regulatory changes and the MHRA needs to assess how it works. This does not, as the noble Lord may recognise, amount to a realistic exercise. We will not have all the pieces to assess before he asks us to conduct the assessment and also provide an alternative. Change takes time. The standstill period for medical devices, for example, lasts two and a half years, in recognition of this, so while some changes are likely to be made to the regulatory regimes within three years, some will not. When his proposal amounts to no more than a year of operable amending legislation to assess and consolidate—perhaps less—it is therefore impracticable.

This issue is compounded by the noble Baroness’s Amendments 2, 27 and 40, which would introduce a sunset clause to the regulation-making powers in Parts 1, 2 and 3 of the Bill, in effect creating a new cliff edge at the end of three years, after which the existing regulatory regimes cannot be updated. If what the noble Baroness seeks is similar to what the noble Lord, Lord Patel, seeks—an assessment of whether secondary legislation is the right place for the regulatory regimes—I say to her that the means simply do not fit the ends. Introducing a cliff edge in legislation is unhelpful. It forces legislation on to the timescale of a sunset clause. It does not allow for pandemics or for the consideration of new developments that arise and need to be addressed.

The noble Baroness’s amendments would further compress the timescale, stripping out another year. Working back from a sunset clause of three years’ time, we would need Royal Assent of a new Act by then. Let us be generous and provide for a year of parliamentary scrutiny. We began this Bill in February last year; it is January now and we must allow parliamentary drafters to do their job of translating policy intent into clauses. The noble Baroness and the noble Lord have both argued in favour of a very different drafting approach: let us give them, say, a year. While that may seem a long time, I suggest that many noble Lords have experienced the challenges of drafting amendments. There are questions about intent and about the choice of language, and these would apply to tens and possibly hundreds of clauses. Suddenly, that time is not very long at all. That then leaves us with a year from Royal Assent to begin the drafting process—not even the assessment process. All the problems I have already mentioned, including the inability to set up a regime to assess and not only pass legislation but implement that legislation, apply, but much more urgently.

We must also consider the impact on those who are being regulated. The arguments I advanced in Committee on the uncertainty that this would create for businesses, manufacturers and, importantly, patients apply very gravely but would become even more critical. In effect, we would be making regulation in 2021—potentially substantive, bold new regulation to protect patients from harm and ensure the highest standards of safety for medical devices—but we would also be saying that this would be immediately under review, and potentially completely rewritten within three years. The new policy to be delivered by these regulatory changes would not be able to come into force, be implemented and enforced before we would be back here again. I simply cannot think that this is good regulation.

I am sympathetic to the issue of how Parliament assesses our plans. There are, of course, avenues open to Parliament to consider whether it wishes to express a view to the Government on any particular topic. We have Select Committees to scrutinise government policy and we have provided for a reporting requirement in the Bill that gives Parliament the opportunity to reflect on the legislation we have made under the Bill in the first two years and any plans we have at that point to make further changes in response to concerns and proposals raised in relation to it. There are institutions such as the Law Commission that can be called upon to take a view on whether legislation is the right legislation, or too complex. However, if noble Lords want me to say, “In three years, we will have made changes under this Bill that are right to consolidate, and we will be in a position then to review and assess and produce something for Parliament to look at,” I simply cannot give them that assurance; nor can I say anything similar to the noble Baroness.

We need to make changes to the regulatory regimes and follow the full and thorough processes to do so, including public consultation and, most likely, draft affirmative amending regulations. We need to have them working, understood and operable by industry and the regulators. Getting that up and running is where I think we need to direct our resources, before we can think about reviews of how it works. To that end, I hope the noble Baroness understands why I am not able to concede here. I hope she feels able to withdraw her amendment and that the noble Lord will not feel compelled to press his.

[Baroness Thornton (Lab)]

I thank the Minister for that. The words, “Yes, Minister” came to mind. It was a very long, wordy way of saying no, but I suppose he had to say it. I thank the noble Lords, Lord Patel and Lord Kakkar, the noble and learned Lord, Lord Mackay, and the noble Baroness, Lady Jolly, for their support and their speeches, as well as my noble friend Lord Hunt and other noble Lords. I particularly agreed with the noble Lord, Lord Naseby. Although we may disagree about sunset clauses, he absolutely hit the nail on the head about the need for consolidation. We link these together because we think there needs to be a time limit.

The Minister said absolutely nothing about what he thinks may happen next. It is simply not acceptable, and the House of Lords scrutiny committees—the Constitution Committee and the Delegated Powers Committee—said that it is not acceptable, democratic, accountable or even safe to continue to run this area of public policy simply by regulation. Since the Minister and the Government have not brought forward anything that actually tackles that problem, that is what this suite of amendments seeks to do. All the discussion we have had in the past hour tells me that we are right to do this.

I say to the noble Lord, Lord Lansley, who mentioned the Law Commission during our discussions about this, that that is a bit of a phantom. We all know that the Law Commission works on a three- to four-year cycle. It is a law unto itself: the Government cannot instruct the Law Commission to do anything, quite rightly. That may or may not be the right way forward, but it could take 10 or 15 years: it certainly does not hurry itself. So, in theory it is quite a nice idea, but I suspect that it would probably not work within the time limits we have before us.

I listened carefully to the Minister. It was a classic explanation of why something cannot be done and, on that basis, since the Minister seems to think that nothing can be done, I beg to test the opinion of the House.

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[Baroness Thornton (Lab)]

The noble Baroness, Lady Jolly, and I are not in a competition about who can speak most briefly, but we have promised the Minister that we will—I overshot my promised three minutes by a minute in an earlier speech.

I say from these Benches that we will support this amendment and we are very pleased to be doing so. I reread the debate and discussion in Grand Committee, and I was actually so impressed with my remarks that I am nearly tempted to read them out again, but I will not do so. I also have to say that the whole debate was very good and important.

As my noble friend Lord Hunt says, this is not just about this Bill; this is about how the Government intend to move forward in terms of legislation and policy and subject themselves to appropriate scrutiny. That is what this amendment is about, in our view, and that is why we will support it.

[Lord Bethell (Con)]

My Lords, I am afraid I will breach the convention on short speeches, but only because this has been an incredibly powerful debate. The points were made very thoughtfully, and I am grateful for the fact that they were made briefly. I want to tackle them head on and perhaps, I hope, persuade the noble Lord, Lord Sharkey, to back off from these amendments.

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Moved by

[Lord Bethell]

4: Clause 1, page 1, line 9, leave out subsection (2) and insert—
“(2) In making regulations under subsection (1), the appropriate authority’s overarching objective must be safeguarding public health.”Member’s explanatory statement
This amendment provides that the appropriate authority’s overarching objective in making regulations under Clause 1 must be safeguarding public health.

[Lord Bethell (Con)]

My Lords, one of the key qualities of this place is bringing to bear years of expertise in refining legislation. From those involved in life sciences to ex-Health Ministers, we have between us cumulative decades of experience. In moving this amendment, it may be convenient if I speak also to Amendments 6, 8, 9, 11, 29, 30 to 33, 42 to 45 and 47.

I am very grateful to all noble Lords who spoke at Second Reading, who have written, who have met with me and who spoke in Grand Committee on the fundamental points that we are discussing now through Amendment 4: how we ensure that we have the powers needed to make regulatory changes to the bodies of law that govern medicines and medical devices; how we ensure that the changes are swift and safe, and support the continued availability of medicines and devices; how we ensure that essential changes are practicable in a fast-paced environment; and how we provide confidence in the checks and balances built into the framework in which these powers can be exercised.

The amendments that I have tabled are the result of detailed talks. I pay tribute in particular to my noble friend Lord Lansley, the noble and learned Lord, Lord Woolf, and the noble Baroness, Lady Thornton. Their amendments in Grand Committee can be seen as the seeds from which my amendments have grown. I say “my amendments” but I view them as a collective effort—an evolution from our discussions in Grand Committee and refined through cross-party conversation. I will come to and address the noble Baroness’s amendments to my amendments, where I hope I can provide further assurances.

As I have said before, this Bill is a framework Bill. It is so because we must have powers that allow us to work with the comprehensive and established regulatory regimes that already exist. We must also have the means to respond effectively, swiftly and appropriately to questions asked. My noble friend Lord Blencathra and his committee asked us very politely to look again at our drafting, and noble Lords suggested that the Bill needed to move from a skeleton Bill to a true framework Bill.

Amendments 4, 6, 8, 9 and 11 make a number of important changes to the regulation-making powers in Clause 1. They provide for the overarching objective sought by my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf. When exercising the power to make regulations, they are to be made in pursuit of the objective of safeguarding public health. That provides all the benefits that my noble friend set out in Committee—an objective test. I do not propose to dwell long on this, as my noble friend explained it so eloquently when he proposed his own amendment then.

However, the noble Baroness, Lady Thornton, has put forward Amendment 5, which would alter the wording of that overarching objective. This would amend the objective from safeguarding “public health” to safe- guarding

“the health and safety of the public”.

This was, as she knows, the original language of the government amendment in Grand Committee. I expect that the noble Baroness is querying rather than pressing us on this drafting. I say to her that, in the spirit of collegiate drafting, we have adopted the language proposed by my noble friend Lord Lansley. He made a good argument in Committee; we have listened. It was repeated during our conversations outside Committee, and we saw this amendment as a product of the whole House rather than simply the Government. I hope that that answers her questions here.

Turning back to the government amendments, they update the considerations that must be given regard to in pursuit of that objective. Noble Lords did not find the clarification of “attractiveness of the UK” clear enough. A number of alternatives were proposed, setting out the sorts of activities that noble Lords thought were good things to promote. My amendment does away with “attractiveness” and supplies a consolidated list of the sorts of activities that we hope the UK will be seen as a favourable place to undertake. This is absolutely in line with the Government’s intention to support the life sciences sector that we have now and to encourage innovation and interest in the UK as a good place to do business in future.

Among others, my noble friend Lady Cumberlege, the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Thornton, made salient points about the importance of safety. While there has never been any intention that making the UK attractive to the life sciences sector should make patients less safe, 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.

This is very clear. There may, as I said earlier during the Bill’s passage, be instances where we do need to make changes that deregulate to ensure the supply of medicines. We have made changes to address the rollout of a vaccination programme; that is absolutely the right thing to do. It requires an assessment of the risks by the experts and requires the benefit—a benefit that the noble Lords who spoke to me at length on this agreed was present—to outweigh the risks. Equally, there is regulatory change that may have no impact at all on safety.

In Amendments 12, 34 and 48, the noble Baroness, Lady Thornton, presses me on the criteria for making this assessment of risks and benefits and on whether the Government will publish that assessment. On the latter point, I can assure her that the amendments made in Committee entirely provide for this. We have already committed to publishing our initial assessment of proposals when we go out to public consultation. That will be the first exposure of our thinking on all aspects, not just risks and benefits. It will be open for persons who respond to that consultation to disagree with us. On the basis of that consultation, we will publish an Explanatory Memorandum when we lay the regulations. There will be ample opportunity to check our homework.

On the criteria, it will not be news to the noble Baroness when I talk of the challenge of specifying a single set of criteria that could apply for the assessment of the risks and benefits of all changes, when regulations may make vastly different changes to the existing regimes. I know that we spoke about these issues with other noble Lords during the discussions preceding Report. I simply do not think that this is necessary or helpful. When the Secretary of State makes amending or supplementary regulatory changes, the Minister will take advice, including from the host of experts inside the MHRA and the VMD, whose day-to-day responsibility it is to protect safety. We have all heard from the excellent Dr June Raine on the importance of safety. It makes sense to take a sensible approach to assessment, particularly in the light of the fact that we will set it out in the ways I have spoken to.

I am very pleased that we have arrived at a formulation that works. It is practicable and good legislation at the same time. Amendments 29 to 33 repeat this set of changes in relation to the regulation-making powers at Clause 9 for veterinary medicines—with an important distinction. The difference relates to how the overarching objective is formulated. This reflects the material differences and choices made for the regulation of veterinary medicines, such as reserving certain medicines for use in humans to avoid further antimicrobial resistance. It is right that we have an objective but that that objective works in this context. It is also right that the same lock on safety is applied.

Amendments 42 to 45 and 47 would apply the same framework to the regulation-making power in Clause 14 in relation to medical devices. When making amending and supplementary changes to the regulation of devices, it provides a separate but similar list of activities that we would wish to be seen as favourable, including the addition of carrying out research on medical devices. In the light of our debate in Committee and the debate we have ahead of us on the importance of medical technologies, this inclusion is absolutely right.

I do not propose to take significant time speaking to Amendments 73 and 94. They both make minor changes, but for an intent with which I do not think any noble Lord would disagree. In the interests of clarity, Amendment 73 would require a consultation on regulations under Clauses 1, 9 or 14 to include a summary of the assessment of the person making the regulations of all matters mentioned in these clauses. Amendment 94 serves to clarify the commencement of the definition of “human medicines provision” at Clause 5.

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[Lord Bethell (Con)]

My Lords, I completely concur with the noble Baroness, Lady Jolly. This has been a fascinating debate but I will restrict my comments to a few specifics in answering some of the questions raised by noble Lords. I shall start by talking briefly about risks and benefits, which I hope will provide further reassurances to noble Lords regarding their questions on these points.

A regulatory change that, for example, makes changes similar to those made to ensure the smooth vaccination programme for Covid-19, will require different assessment to those that change the medical devices regulatory regime to step up scrutiny of medical devices. The noble Lords, Lord Patel and Lord Kakkar, spent some time in Committee speaking to the importance of medical device regulation, and I agree with them. The amendments that I have tabled are silent on whether the impact on safety must be negative or positive to have the “lock” kick in. It applies to both.

However, it will come down to what the change is in order to determine what constitutes a risk in that scenario versus a benefit. That is obvious in the case of the Covid vaccine rollout. There is greater benefit to a smooth rollout of the vaccine programme than the risk of increasing the number of healthcare professionals who can deliver it. Risks can be mitigated, and they should be. Changes can also be highly technical. They may affect the safety of medicines or medical devices in a minor way but not to the same degree or extent as other changes. It would be impracticable to develop criteria that apply in all circumstances to all regulatory changes.

In response to my noble friend Lord O’Shaughnessy, I should reassure him that it is not our intention to in any way water down or reduce standards in the life sciences area. Instead, it is our intention to use this legislation to champion the UK’s wonderful life sciences sector.

We have often spoken of safety—I thank the noble Baroness, Lady Thornton, for her words on that matter—and of the vital importance of the regulator putting this at the heart of its work. Our regulator is stuffed full of scientists and experts. They are able to support the Secretary of State in making that assessment, based on the evidence. Would this change impact the highly regulated safety considerations, and are they the right ones to make? We need to empower those experts to make those recommendations, in specific circumstances. I hope that noble Lords agree with me that the Bill is better for the changes that we have already sought to make, that the questions behind these further changes are answered, and that we have reached a point of conclusion.

[Baroness Thornton (Lab)]

That debate was definitely worth having, notwithstanding the fact that the noble Lord, Lord Lansley, explained the process that we had gone through when discussing what to do and how to improve the Bill regarding these aspects. They were important discussions. The noble Lord, Lord O’Shaughnessy, asked pertinent questions that the Minister has answered and are now on the record. I thank the noble Baroness, Lady Jolly, for explaining why we felt that it was important to have this discussion. I also thank other noble Lords for their remarks and the support they have given. I beg leave to withdraw my amendment.

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Moved by

[Lord Bethell]

6: Clause 1, page 1, line 11, leave out “they would” and insert “regulations under subsection (1) would contribute to this objective”
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name substituting Clause 1(2).

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[Baroness Thornton (Lab)]

I am grateful to the noble Lord, Lord Clement-Jones, for his full and comprehensive explanation of the background thinking behind this amendment. It is clearly important that we understand and have clarity about the scope of Clause 3, and it is that clarity we seek from the Minister this evening. As my noble friend Lord Hunt said, we are urging the Minister to respond about how Clause 3 might be used. It is not good practice when you are law-making to put something in a Bill that might just come in useful at some point. The House probably needs a wider explanation and reassurance about this clause and how it will be used.

[Lord Bethell (Con)]

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 (LD) [V]]

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.

Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) (No. 4) Regulations 2020

Lord Bethell Excerpts

Thursday 7th January 2021 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 30 December 2020 be approved.

Relevant document: 40th Report from the Secondary Legislation Scrutiny Committee. Instrument not yet reported by the Joint Committee on Statutory Instruments.

Motion agreed.

Covid-19: Restrictions

Lord Bethell Excerpts

Thursday 7th January 2021 Lords Chamber

[Lord Robathan]

To ask Her Majesty’s Government what assessment they have made of the success of the restrictions introduced to address the Covid-19 pandemic in reducing the transmission of Covid-19 between 1 July and 31 December 2020.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, the science of virus transmission is very simple: tiny bugs spread by contact and by breath. Lockdowns work because they put space between people, but there are costs—horrible costs. That is why each day we publish gigabytes of data on infection rates, we analyse the patterns and we design lockdowns to have the maximum impact for the lowest economic and social cost.

[Lord Robathan (Con)]

My Lords, yes, but: in the last few months we have seen ever more stringent restrictions—tiers 3 and 4, the failed circuit breaker in Wales, a second lockdown which ended only just over a month ago, and now a third lockdown—yet cases keep rising. The Prime Minister said on “The Andrew Marr Show” on Sunday that the evidence is not clear. We all want to see policy based on empirical evidence, so please, can the Minister go back to the department and instigate a detailed examination of why these hugely damaging restrictions have not seen a reduction in infections, hospitalisations and deaths?

[Lord Bethell (Con)]

My Lords, I am extremely grateful to my noble friend for that sage advice. I can reassure him that lockdowns do work—in Leicester, Bolton, Luton, Liverpool—and I can give him very clear case studies of how specific measures have affected national, regional and local outbreak infection rates. The truth is that tier 3 was enough for the original variant, but it is not enough for the new variant, which is 70% more transmittable. That has hit our country hard, which is why we have to have this new, horrible lockdown.

[Baroness Mallalieu (Lab) [V]]

My Lords, the figures surely show that this pandemic is now endemic in our population. Clearly, lockdowns cannot permanently suppress the virus but might just temporarily prevent medical facilities being overwhelmed. What are the Government doing to ensure that vaccination is rolled out 24/7, including by Public Health England, and skilled medical staff on Covid duties are relieved from all non-specialist aspects of their work by the many skilled and suitable volunteers who are offering to help?

[Lord Bethell (Con)]

My Lords, the noble Baroness analyses the situation extremely well and has laid out exactly the Government’s plan for rolling out the vaccine. She is entirely right that we are using lockdowns to bridge the gap until herd immunity is achieved through the vaccine. We have mobilised an enormous amount of the NHS, and are very grateful to the volunteers who have stepped up and are making an enormous difference. We are trying to get as much of the vaccine as possible out of the factories and warehouses, with batch control, and into the country’s surgeries and hospitals to vaccinate millions of people before the spring.

[Baroness Walmsley (LD) [V]]

My Lords, a weak link in the measures to suppress the virus has been the small percentage of people not self-isolating when they should. This is often because they cannot afford to do so. Dozens of times my Lib Dem colleagues and I have asked the Government to provide adequate financial support for self-isolators. So I ask the Minister again: in order to suppress the virus, will the Government pay the wages of poor people who need to self-isolate?

[Lord Bethell (Con)]

My Lords, I pay tribute to the advocacy of the noble Baroness and her colleagues on this important point. I acknowledge the financial pressures on those of limited means who are required to isolate. We have put in provisions for statutory sick pay and the £500 Covid bonus to help to support those people, and there are local authority funds and provisions to provide additional support. The point that she makes is made well and we completely acknowledge the challenge.

[Lord Herbert of South Downs (Con)]

My Lords, does my noble friend share my incredulity that those who are opposed to lockdowns continue to make their arguments, in spite of the fact that cases are obviously rising very fast, in spite of the advent of the new variant, which is more infectious, and in spite of the current very serious pressure that our hospitals are seeing? Is it not the case that, in the end, their arguments boil down to the callous suggestion that somehow elderly people who have pre-existing conditions but might nevertheless expect to live for many more years are expendable, when they are clearly not?

[Lord Bethell (Con)]

My noble friend puts it well. I always welcome the challenge of noble Lords on any subject whatever, but I agree that underlying many of the objections to lockdown appears to be an assumption that some lives matter less than others. Whether you are asthmatic, diabetic, infirm or just old, I think that your life is worth just as much as everybody else’s. That is why I am extremely proud of the national effort to work together to protect those who are less advantaged and to protect our health service.

[Baroness Campbell of Surbiton (CB) [V]]

My Lords, thousands of people who are currently extremely vulnerable are now in greater danger from a lack of protection against the virus. Our care workers are more likely to come into contact with coronavirus, and requests for testing have escalated. Therefore, can the Minister please tell me when I and countless others who employ personal assistants can expect them to be vaccinated? Our workforce is not currently prioritised in the same way as care home workers and registered agency carers.

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[Lord Bethell (Con)]

My Lords, I do not know the precise nature or status of the care that the noble Baroness has, but it is true that care workers are massively prioritised, and those with pre-existing conditions are also prioritised. We cannot prioritise everyone at once. Those over 80 are at the top of the queue, but those who work with the vulnerable, those shielding and those with pre-existing conditions are also towards the top of the list. We are working as hard as we can to get vaccines to those people as soon as possible.

[Baroness Thornton (Lab)]

My Lords, on this second day of national lockdown, it is important to look to the future and make every effort to keep our families and fellow citizens safe. Given how close London’s hospitals are to being overwhelmed—within days—what are the short-term plans to alleviate this very urgent and serious challenge? I gather that the ExCel Nightingale hospital will be used either for in-patients or as a mass vaccination centre, or both. How soon will that happen?

[Lord Bethell (Con)]

The noble Baroness quite rightly pays tribute to the work of the NHS. An enormous amount has been done on the marginal expansion of ICUs. My local hospital, University College Hospital, has increased the number of beds from 19 to 52 by expanding the scope of the wards and the oxygen supply. We have put a huge amount of work into A&E units, often building out the front of the units to create more space. Those marginal differences are being extremely effective, and that is our first line of defence. The Nightingale hospitals are there as back-up and, if they are needed, we will bring them into play.

[Lord Lilley (Con)]

My Lords, perhaps I may break with convention and the advice I was given when I first entered Parliament and ask a question to which I do not already know the answer. Every week, the Government submit figures to EuroMOMO for deaths from all causes. During the spring, the figures showed a huge level of excess deaths over the normal, but currently, and in recent weeks right up to the end of last year, they show almost no excess over the normal level of deaths in this country. That conflicts with all the evidence we are seeing from hospitals and elsewhere. Can my noble friend reconcile the figures and the facts?

[Lord Bethell (Con)]

The CMO has given some guidance on this matter. He has made the observation that deaths from other flus are down, partly because of the social-distancing that is part of the lockdown. He has also pointed out the very sad, but I am afraid inevitable, possibility that the large amount of infection that has grown up in the last few weeks will in time lead to further deaths. This is an uncomfortable piece of speculation but, as sure as night follows day, I am afraid that infections and hospitalisations will lead to further deaths. We are running at nearly 1,000 a day at the moment and that number is set to increase.

[Baroness Falkner of Margravine (CB)]

My Lords, I refer to my interests as set out in the register and point out that my remarks are personal. Compliance and transmission are interlinked, and transmission rates are hugely dependent on public compliance. So I echo the point made by the noble Lord, Lord Herbert, that, although senior libertarian individuals and leaders point to the fact that individuals can make their own assessments of risk, that is not the case. Does the Minister agree that complying with the rules is a public duty that we owe one another and not a matter of choice?

[Lord Bethell (Con)]

The noble Baroness makes the point well. My observation is that the British public are extremely supportive of both the lockdown and the measures involved. Of course, we all see highly visible exceptions in our travels and when we work, but by and large the British public have massively complied with the measures without any severe form of compulsion, and for that I pay an enormous amount of tribute. In the first lockdown, we had to behave as though the person we saw near us might have the disease; the suggestion now is that we should behave as though we have the disease. It is that discipline that we all need to apply.

[The Deputy Speaker (Baroness McIntosh of Hudnall) (Lab)]

My Lords, the time allowed for this Question has now elapsed.

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

Lord Bethell Excerpts

Thursday 7th January 2021 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 11 December 2020 be approved.

Relevant document: 40th Report from the Secondary Legislation Scrutiny Committee. Instrument not yet reported by the Joint Committee on Statutory Instruments.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, today we have more than a million people in Britain infected with Covid. A third are asymptomatic, and most are highly infectious. That is just too many. That is why on Monday the Prime Minister announced a new national lockdown. The measures are tough but necessarily so. They reflect not only the current case rate but the extent of the pressures faced by our health and care system.

We have over 30,000 people with Covid in hospital beds, with over 2,500 people on mechanical ventilation, and based on the infection rates of the last month and the inevitable clinical chain reaction those numbers are set to rise. Yesterday, sadly, the UK reported a further 1,041 people who had died after testing positive in the 28 days previous and, with yesterday recording our highest daily increase since mass testing began, unfortunately it is inevitable that more deaths are on their way. That is why the Government took swift and decisive action this week, introducing a national lockdown and closing schools. We take this action with deep regret—for society and for the economy—but it is necessary to respond to the grave situation that we face.

The SIs we are debating today cover the tiering system introduced following the November national lockdown. Those regulations have been amended five times to extend the geographical reach and to fine-tune the terms, and we are also debating this week’s national lockdown. Overall, these SIs tell the story of our containment of the original strain of the virus, with a tiering system that eventually proved to work. They also cover the subsequent identification of and reaction to a more transmissible strain of the virus that was far more aggressive than anything that had been seen anywhere in the world before.

The New and Emerging Respiratory Virus Threats Advisory Group spelled it out clearly: the new variant demonstrates a 70% increase in transmissibility. This means that successful measures that were previously in place such as tier 3 are no longer enough to reduce the transmission of cases. The new variant makes up around 60% of cases in some parts of England, and that is rising. Since the beginning of December, cases reported per day in the UK have steadily increased, with on average 15,000 reported in the week of the 6 December, 34,000 in the week of 20 December, and a shocking 57,000 in the week to 3 January. This will inevitably lead to more hospital admissions and increased pressure on secondary care over the coming weeks. This is why a national intervention, introduced swiftly, is so necessary, and why the tier 4 measures have been strengthened by the closure of schools.

We are also taking on additional measures to support industry given the further national restrictions. We have announced additional support to the most affected businesses worth £4.6 billion across the UK. This support will help businesses get through this difficult period until spring. We will take further decisions about our economic response to coronavirus and how best to support the economy, businesses and jobs at the Budget on 3 March.

We have aimed to balance the economic impact of greater restrictions on business with measures to protect public health. Implementing a national lockdown with the vaccine rollout will allow the nation to return to some sense of normality and for the economy to bounce back. We have mitigated the short-term impact through financial support schemes to reflect these changes, and will carry on supporting the British public through these tough times.

However, we are not back to the bleak days in March: hope is on the horizon. The rollout of the Pfizer and AstraZeneca vaccines is making excellent progress. We have now vaccinated over 1.1 million people in England and over 1.3 million across the UK. The rollout in care homes started on 16 December, meaning that our most vulnerable as well as vital care staff can be protected.

While the vaccines project is an international collaboration, we should take a moment to recognise the contribution of the British life sciences sector and to reflect that an easy-to-administer, affordable and mass-produced vaccine offers Britain a way out of this disease and will make a huge impact on the global response.

The end is in sight but, until that time, we must all take responsibility for reducing the transmission of the virus, protecting the NHS and saving lives by complying with these restrictions. I know that these measures require a huge sacrifice. They are designed to minimise our social contact, coming at the cost of seeing our friends and family, participating in the hobbies we love and preventing us taking those holidays we desperately look forward to, and the economic cost is high. But this is a price worth paying to help our key workers, who have dedicated themselves for the benefit of others. We owe it to them and to protect the economy from a collapse in confidence and from rolling lockdowns.

The other SI that we are debating today relates to the self-isolation periods for households and is another example of how we have applied what we have learned. We are doing everything we can to identify and isolate the infectious. Between 25 December and 31 December, 346,901 people across the UK tested positive and were told to isolate, and a further 493,573 people were identified as recent close contacts, of which 92.3% were reached and told to self-isolate. This is a massive national effort.

On 14 December, we amended these regulations to make changes to the self-isolation period for households, non-household contacts and international arrivals, reducing it from 14 days to 10. This is based on evidence showing that the likelihood of being infectious as a contact after 10 days is low. To bring our policy in line with other nations in the UK, the 10-day self-isolation countdown begins on the day after exposure, onset of symptoms, or a positive test result.

Before I finish, I will address the question of parliamentary scrutiny. I want to be clear that no one in the Government makes use of these emergency procedures lightly, nor do they do so without the conviction that they are absolutely essential. Unfortunately, as I have set out and as we have seen across recent weeks, urgent action has been required. I know that some of your Lordships may be disappointed that the amendments were made before there was a debate. However, I emphatically reassure them that we remain committed to parliamentary scrutiny. I commend these regulations to the House.

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[Lord Bethell (Con)]

My Lords, we are debating today the 59th regulation in a restriction round—quite a colossal number. They are unfortunate and regrettable, but they are necessary. This Government are committed to making them the best they can be, and I am extremely grateful to noble Lords for their recommendations and suggestions on the restrictions. Let me trot at pace through a few of the recommendations from noble Lords.

Noble Lords are entirely right that money to isolate is an incredibly important element of the effectiveness of isolation. I reassure noble Lords that we are in active dialogue with 314 local authorities to figure out how to make the isolation payments more effective and mobilise charities’ and local authorities’ support for those who need it.

A number of noble Lords brought up travel restrictions. I completely agree with the noble Lords, Lord Winston and Lord Reid, that international travel has been a source of infection for this country in the first and second waves, and continues to be. The prospect of a South African variant that is even more transmissible than the Kent variant puts a spotlight on that threat of infection. That is why we are working on processing new measures, which will be introduced shortly, for pre-flight testing for travellers to Britain, and we look forward to those being announced shortly.

In the meantime, I have to break it to the noble Baroness, Lady Jolly, that test-to-release, which she mentioned, was introduced on 15 December. I get a weekly update on it, and I can reassure her that the evidence to date suggests that the isolation of travellers on test-to-release is much more effective using the testing mechanism than it was on the isolation mechanism. We will probe those figures very carefully, but I am optimistic that that scheme has worked well.

My noble friend Lord Lancaster mentioned the tiering system. It is a grim prospect, but I warn noble Lords that we are unlikely to spring out of this national lockdown straight into the sunny uplands, and a new tiering system will likely be necessary. The right honourable Secretary of State for the Home Office spoke this morning on the radio about the kinds of penalties that she has instructed the police to apply. I reassure the noble Lord, Lord Berkeley, that our approach to the lockdown is effective and implementing all the regulations necessary.

To my noble friend Lady Altmann and to the noble Lord, Lord Foulkes, and others who asked about test and trace, may I just be crystal clear? I sometimes find I am repeating myself on this matter. In the last week of the year, test and trace identified 450,000 people who had Covid and isolated another 350,000 of their contacts. That is an absolutely incredible achievement. No other country has a scheme like it, and it has become repetitive and inaccurate to suggest that it is not making any impact.

The noble Baroness, Lady Thornton, and others asked where community testing might be going. Of course, during a lockdown, the community testing component is not necessary, but I reassure the noble Lord, Lord McNally, and others that we are very committed to it. We are in dialogue with councils at all levels about how they might use community testing, and with schools about once the lockdown is lifted.

A number of noble Lords looked beyond this lockdown to the future. The noble Baronesses, Lady Finlay and Lady Bennett, asked about ventilation and workspaces. That is exactly where our heads are at the moment; we are trying to understand and think through the implications of this pandemic. The reality is that there will be no quick transition. We shall have to think about workplace hygiene. My noble friend Lady Wheatcroft asked how workspaces will have to be reimagined. I very much welcome the suggestions, evidence and recommendations of noble Lords in this area; it is something that both BEIS and DHSC are looking at very closely, and I look forward to updating the House on that.

A number of noble Lords’ questions and comments were about the vaccines, not the regulations. Since that is the hot subject, let me address it directly. I reassure noble Lords that, whatever they may read in the papers about problems and blockages, the rollout of the vaccines is being done at pace. It includes the Army; volunteers are being mobilised, GPs and pharmacies are being recruited and we will hit the numbers that the Prime Minister has committed to. The noble Baroness, Lady Masham, rightly thanked factory workers and others involved in the process of manufacturing and logistical support in supplying these vaccines. It is an incredible process to put together 30 million or 40 million vaccines before the spring at pace in highly delicate, secure and hygienic environments, and to get them to the front line in a way that is temperature-controlled and fulfils the commitment to the MHRA.

Patient safety must be our priority. That is why it is done in a thoughtful fashion. While we are very grateful to BrewDog and others for innovative ideas for how to roll out the vaccine—through the middle of the night and what have you—we must get it right. You cannot jab someone’s arm and inject them with a potent vaccine without being absolutely sure that it is the right person in the right place, the right vaccine and in the right conditions. Getting all those stars aligned requires an enormous logistical process, and we are absolutely determined to get it right. We also must have availability of vaccine. I thank Pfizer and AstraZeneca for the enormous lengths that they have gone to to provide millions of doses of vaccines, but it takes time to deliver. At the moment, it is not the NHS that is the limiting factor but the provision of the vaccines.

To achieve that provision, we will deliver through hospitals, GPs, pharmacies and mass centres. Today, we have 107 hospital sites online, and there will be a further 100 by the end of the week; there are 595 GP-led sites, and there will be a further 180 by the end of the week. The mass centres will be open shortly, and they will have a huge impact on the rollout.

Obviously, the big vaccination centres have hugely more impact than small pharmacies and rural doctors, but that is not to say that those are not being prioritised as well. However, I ask for noble Lords’ consideration: the practical matter of getting a vaccine that has to be temperature controlled and comes in large packs of sometimes up to 1,000 doses to small rural pharmacies, community pharmacies and GP practices in the far-flung parts of Britain is an enormous logistical exercise—we have to balance scale and volume with breadth and the niche interest. I think we are getting it right; we have not forgotten anyone, but there will need to be a little bit of time before we can reach everyone.

A number of noble Lords have talked about cancelled trips to the GPs; I completely recognise and acknowledge those stories. It is true that, sometimes, we have to line people up for appointments, and the delivery of the vaccines, which is an extremely delicate task, has not always proved to be as reliable as we might have hoped. We are seeking to iron that out, and I ask for the forgiveness and forbearance of any pensioners or patients who have had to wait for their vaccine. I reassure noble Lords that, if there are cancelled appointments, it is only because we are trying to make maximum use of the stock of vaccines that we have at the moment.

On the volunteer scheme, I completely and utterly agree with all noble Lords who are frustrated and irritated by the large amount of bureaucracy that this has involved. As the noble Baroness, Lady Watkins, rightly pointed out, we have stamped on some of it, but there is more to do, and I think that there is a lesson to be learned about how the NHS and British Government treat volunteers, and we are making a lot of progress on that already.

To my noble friend Lady Neville-Rolfe and others who asked whether we are using the Army, I say yes we are using the Army.

On dentists, I reassure my noble friend Lord Balfe that all those with direct patient care are prioritised for the vaccine, whether they are dentists or dentists’ assistants.

I do not recognise so well the stories of the noble Baroness, Lady Brinton, about logistical problems, with car parks and freezing GP surgeries. I am on a vibrant WhatsApp group with MPs, and I am deluged with hundreds and hundreds of positive stories of quick, polite and accessible service. I would be very grateful if the noble Baroness would write to me with her anecdote; I would be glad to follow it up.

On therapeutics, I am grateful to my noble friend Lord Moynihan for his quite accurate remarks on the importance not of vaccines but of the therapeutics that can assist in recovery. We are grateful to RECOVERY and REMAP, the two big clinical trial schemes that have proved to be a massive global success—and, without giving the game away, I am hopeful for more good news from that direction shortly.

I remind my noble friend Lord Cormack that, although he may get his vaccine soon, immunity does not necessarily mean sterility. While he himself may take the vaccine and, therefore, be protected from the impact of Covid, he may be the carrier of the virus. To those, like myself and my noble friend Lady Penn, who are not candidates for the priority list for the vaccine, we would be extremely wary of anyone who has had the vaccine but is still a carrier of the virus. That is a really important policy point that we will have to wrestle with in months ahead.

I reassure the noble Lord, Lord Truscott, that the Oxford vaccine is extremely good, and just as good as all the others.

Lastly, on the NHS, I completely agree with all those noble Lords who pointed out that the second, or potentially the third, time round is tougher for the NHS: there are mental health issues and capacity issues, and there is the sheer miserableness of being back on the front line again. I live opposite University College London Hospital; the sound of the ambulances arriving through the night wakes me all the time. It used to be once or twice a night, but it has been a dozen times a night for the last month, which is a sombre reminder for me, personally, of the front-line experience of those who work in the NHS. I profoundly thank all those who are spending a tough winter looking after those with Covid and other conditions. We are working hard to get volunteers to support the front line, but I acknowledge that that has been slower than perhaps expected. Some £15 million has been allocated for mental health support for those in the NHS, but more can and should be done, and we are consistently working on it.

By way of winding up, I say that these restrictions are extremely regrettable. The noble Baroness, Lady Fox, demonstrates her anger and frustration; I do not really agree with much of what she says, but the emotional frustration she shares is well expressed, I think. However, I cannot hide from the Chamber that the new variants that have developed in Kent, South Africa and elsewhere present a tough challenge for all of us. We have learned an enormous amount about how to contain the virus and we have a huge amount of hope from the vaccine, but we have a long way to go.

Motion agreed.

Health Protection (Coronavirus, Restrictions) (No. 3) and (All Tiers) (England) (Amendment) Regulations 2021

Lord Bethell Excerpts

Thursday 7th January 2021 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 5 January be approved.

Instrument not yet reported by the Joint Committee on Statutory Instruments.

Motion agreed.

Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) Regulations 2020

Lord Bethell Excerpts

Thursday 7th January 2021 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 14 December 2020 be approved.

Relevant document:40th Report from the Secondary Legislation Scrutiny Committee

Motion agreed.

Obesity

Lord Bethell Excerpts

Tuesday 5th January 2021 Lords Chamber

[Baroness Walmsley]

To ask Her Majesty’s Government what assessment they made of the report by the All-Party Parliamentary Group on Obesity The Future of Obesity Services, published on 25 November 2020.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, we welcome the ongoing work and support of the All-Party Parliamentary Group on Obesity and its report The Future of Obesity Services, which continues to make a valuable contribution to the debate. We published Tackling Obesity: Empowering Adults and Children to Live Healthier Lives last July, which demonstrates an overarching campaign to reduce obesity, takes forward actions from previous chapters of the childhood obesity plan and sets out measures to get the nation fit and healthy.

[Baroness Walmsley (LD) [V]]

I thank the Minister for his reply, but he will know that we have had several obesity strategies before. What steps are the Government taking to ensure that this latest strategy is implemented in full without delay? Can he provide an update on the timelines for implementation? One of the main concerns of our witnesses was that the full range of services should be provided everywhere in the country, with easier access at any stage of the pathway. Will the Government take this on board?

--- Later in debate ---

[Lord Bethell (Con)]

I thank the noble Baroness very much for the recommendations of her report. Implementation is key. We have 13 workstreams, which is too much for me to go through in detail, but yesterday evening I tweeted a full list of each of them for her interest. Her point about implementation on the front line is extremely well made. I reassure her that the NHS plan makes it very clear that front-line services should provide obesity support in all the right cases.

[Baroness Stuart of Edgbaston (Non-Afl)]

My Lords, the report quite rightly encourages the Government to continue their promotion of better health and to develop an obesity prevention strategy. Twenty years ago, food was moved largely out of the Ministry of Agriculture into the Department of Health. Obesity is a question of our relationship to food. Could I encourage the Minister, in the light of changes to the way we do agriculture, to focus also on health and how, locally, the relationship between health, agriculture and the provision of food can actually be deepened?

[Lord Bethell (Con)]

The noble Baroness puts her point extremely well indeed. Undoubtedly, there is a movement in the country as a whole to relate more closely the production of food in this country and the way in which healthy eating relies on good, locally produced food, and I take on board her points entirely. We very much take obesity more seriously as a result of Covid. That has given our plans a huge amount of energy, and the sponsorship of the Prime Minister has been very vocal.

[Lord Holmes of Richmond (Con)]

My Lords, would my noble friend agree that serious mental illness—SMI—must be a significant factor in the commissioning of and referrals within obesity services if those currently experiencing obesity and mental illness are to get the service, support and help they need?

[Lord Bethell (Con)]

My Lords, not everyone who is obese has mental illness, but some people who are obese do have mental illness. That is why we announced measures on weight management in Tackling Obesity: Empowering Adults and Children to Live Healthier Lives, which makes clear proposals for how those who have obesity as part of their mental illness challenge can be supported and provided for.

[Baroness Boycott (CB) [V]]

My Lords, I obviously welcome the report from the APPG, but I feel that we have heard it before and that its problem is in its implementation. I would like to make the point that a lot of our emphasis on the prevention of obesity is about stopping the promotion of unhealthy foods, whereas we do very little to promote healthy foods and to make a healthy diet affordable. Children from the poorest households are, at the moment, the most likely to suffer from obesity, but they are also suffering from food poverty. Healthy food is currently twice as expensive per calorie as unhealthy food, so just having a policy of restricting access to unhealthy foods can actually risk pushing people more into hunger and making them end up eating cheaper food. So, in order to address the inequalities in obesity levels, it is vital that restrictions in promotions of unhealthy food must be balanced by an increase of healthy foods, plus a really good public health campaign that encourages people to eat more healthily and tells them how.

[Lord Bethell (Con)]

The noble Baroness makes her point very fulsomely. We are doing a huge amount on advertising, promotions, front-of-pack nutritional labelling, out-of-home calorie labelling, alcohol calorie labelling and a whole range of stuff. The noble Baroness may well shake her head, but the truth is that this Government are doing more than any previous Government in this matter.

[The Lord Speaker (Lord Fowler)]

Could we have short supplementaries, please? I call the noble Lord, Lord Brooke of Alverthorpe.

[Lord Brooke of Alverthorpe (Lab) [V]]

My Lords, I declare an interest as a member of the all-party parliamentary group involved with the report. We recommended that the Government should build on their Better Health campaign with a public information campaign. Picking up on the last point of the noble Baroness, Lady Boycott, and on the Minister’s remark that he had tweeted about the 13 streams, is not the basic problem that the public are not aware that we are trying to run a campaign and that we need a clear relaunch? This is the opportune moment to do it, when we have such problems with Covid.

[Lord Bethell (Con)]

The noble Lord rightly alluded to the Better Health campaign, and I remind him that we did relaunch it yesterday. That went extremely well and got a lot of coverage. But there is only so much that government advertising can do; I do not think that we can advertise our way out of this problem. It is up to individuals to make their own decisions, it is up to GPs to give the support that people need and it is up to us as a society to accept that the health of the nation is important to its resilience and to its long-term health. Until those decisions are made, we struggle to make progress in this area.

[Baroness Jolly (LD) [V]]

My Lords, what works in rural Cornwall may not work in metropolitan Camden. Could the Minister tell the House whether there is a plan to require local integrated care systems to develop a local obesity prevention and treatment strategy for their population, strengthening existing services and sharing good practice across the national network?

[Lord Bethell (Con)]

Yes, I am glad to be able to reassure the noble Baroness that ICSs will be instructed to take obesity as part of one of their primary framework objectives. In fact, that is a very good example of how ICSs will make a big impact on complex issues such as obesity and how that impact will be felt in far-flung communities such as those in Cornwall.

[Lord Vaizey of Didcot (Con)]

My Lords, there is much to commend in the Government’s obesity strategy, but the restrictions on broadcast advertising are completely wrong-headed and based on no evidence whatever. In fact, I think that the Government’s own impact assessment says that it would reduce calorific intake by 1.7 calories—the calorie value of a Tic Tac. If the Government are determined to pursue this wrong-headed strategy, could the Minister assure me that they will not impose further restrictions on broadcast advertising until they level up and impose the same restrictions on online advertising?

[Lord Bethell (Con)]

My Lords, I can give my noble friend no such assurance. The decrease in sugar in soft drinks, as he knows full well, between 2015 and 2019, was 43.7%, and the increase in soft drink sales during that time was 14.9%. With six out of 10 adults and more than one in three children between the ages of 10 and 11 technically obese, clearly more needs to be done.

[Baroness Thornton (Lab) [V]]

My Lords, I think that the noble Baroness, Lady Boycott, is quite correct, and I did appreciate the Minister’s last answer to his noble colleague. But perhaps the Government need to consider healthy food where they can actually influence this, such as in hospitals, schools and care homes, and reinstate standards for healthy foods in those places.

[Lord Bethell (Con)]

Yes, I entirely agree with the noble Baroness. There are parts of the Government’s estate where more could and should be done in order to promote healthy foods. I pay tribute to the work of Prue Leith, who has done a lot to champion healthy food in hospitals. Progress has been made; I visited Southampton hospital with her earlier last year and saw her bringing healthy food direct to the patients, and the use of trolleys in order to ensure that warm food is delivered and that food does not have to come out of a plastic bag. More can be done, but I reassure the noble Baroness that we are working hard at it.

[Lord Singh of Wimbledon (CB) [V]]

The Sikh community has for some years run lectures and health checks in gurdwaras to reduce the calorie-rich diet of those from rural communities to one more suitable for the more sedentary occupations in the UK. Would the Minister agree that, with a little support from the Government, our places of worship can be of real help in reducing an above-average incidence of obesity and associated health risks in those from the subcontinent?

[Lord Bethell (Con)]

The noble Lord makes an incredibly important point, and he makes it very delicately. I am extremely grateful to him for bringing this to the Chamber. It is true that many people from rural communities in the subcontinent bring with them eating habits that are simply not appropriate for modern life. We have seen that in Covid, where some of the most challenging incidences of Covid ITU have been in communities with a high level of people from the subcontinent, whose eating habits have, frankly, left them in no good state to fight this horrible disease. Tackling that issue is extremely complex, and I am extremely grateful to the Sikh community for setting this good example.

[The Lord Speaker (Lord Fowler)]

My Lords, the time allowed for this Question has elapsed. We now come to the third Oral Question.

Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) (No. 3) Regulations 2020

Lord Bethell Excerpts

Wednesday 30th December 2020 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 29 December be approved.

Instrument not yet reported by the Joint Committee on Statutory Instruments.

Motion agreed.

Health Protection (Coronavirus, Restrictions) (All Tiers and Obligations of Undertakings) (England) (Amendment) Regulations 2020

Lord Bethell Excerpts

Wednesday 30th December 2020 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 21 December be approved.

Instrument not yet reported by the Joint Committee on Statutory Instruments.

Motion agreed.

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

Lord Bethell Excerpts

Wednesday 30th December 2020 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 17 December be approved.

Instrument not yet reported by the Joint Committee on Statutory Instruments.

[The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)]

My Lords, despite all the pressure we are under, I would like to take a moment to celebrate some good news. The Government have today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency to authorise Oxford University/AstraZeneca’s Covid-19 vaccine for use. This follows rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness. We have hundreds of thousands of doses ready to go and 100 million on order—enough for everyone.

On 4 January, the NHS will start administering doses to a revised list that reflects many of the interventions by noble Lords in this Chamber in recent debates. While the vaccine project is an international collaboration, we should take a moment to recognise the contribution of the British life sciences sector and reflect that this easy-to-administer, affordable and mass-produced vaccine offers Britain a way out of this disease, and will make a huge impact on the global response.

But, in the meantime, news from the front line remains grim. While the November national restrictions drove cases down in most areas, it is now clear that cases are rising again at a worrying rate. Across the whole country, cases have risen 57% in the last week, driven by the highly transmissible new variant. The number of people testing positive for Covid-19 has increased rapidly and a growing proportion have the new variant. Data from 29 December showed that there were an enormous 53,135 new Covid cases across the UK—half with the new variant—an increase of 272,551 over seven days. NERVTAG has concluded that the new variant demonstrates a substantial increase in transmissibility, of around 70%, and the R value appears significantly higher, with initial estimates at 0.39 and 0.93 higher—a massive margin in epidemiological terms.

In September, we introduced the tiering framework, which we built upon and refined in December. This is designed to provide a flexible and responsive system, which allows areas to move up and down the tiers as case rates change. It proved effective, with many areas containing transmission. Despite our efforts, the new variant has changed things. It forced us to establish the new tier 4 and to move regions, such as London and the majority of the south-east, into this higher tier.

The good news is that there is no evidence, at this stage, to suggest that the new variant of the virus is likely to cause more serious disease, that our current testing regimes will not detect it or that a vaccine will not respond effectively to it. For this, we give thanks. But the bad news is that there is no data showing that it causes less disease. The new variant accounts for 60% of cases in London and is growing around the country. As always, we see that increased infections lead to increased hospital admissions and loss of life. I need hardly remind noble Lords that this is a time when the NHS faces enormous challenges from winter pressures, its commitment to elective procedures and now the new variant. That is why we introduced the tier 4 stay-at-home measures we are debating today.

As in the November lockdown, people in tier 4 areas must stay at home and not travel out of tier 4. They may leave only for a limited number of reasons, such as work, education or caring purposes. People elsewhere are advised to avoid travelling into tier 4 areas. In tier 4, support and childcare bubbles are the same as in all other tiers. However, all non-essential retail and indoor entertainment will close. International travel is restricted to business trips. The clinically extremely vulnerable in tier 4 areas should do as they did in November and stay at home as much as possible, except to go outdoors for exercise or to attend health appointments.

However, we have listened to noble Lords in this Chamber and the public about what is important for the way people go about their daily lives. Unlike under the November restrictions, communal worship and a wide range of outdoor recreation are permitted. The restrictions imposed in tier 4 areas are hard, but necessarily so. They are designed to reduce transmission of this new variant, so that the NHS is not overwhelmed and we can return to normal as quickly as possible. These stricter rules are in line with other major European countries.

In addition to Greater London, other areas have now moved into tier 4, including Cambridgeshire, the rest of Essex, Norfolk, Suffolk, West Sussex, Hampshire, Southampton, Oxfordshire and Waverley. These changes took place on Boxing Day. We have balanced the economic impact of greater restrictions on business with measures to protect public health. These restrictions impact business in the short term, which is hugely regretful, but we should be clear that they will be economically beneficial in the long term, because we will get back to normal quicker. We are also mitigating the short-term impact through financial support schemes.

On 19 December, we had to take the horribly difficult decision to reduce the Christmas bubble exemption. I know that this meant that the majority of us could not celebrate in the way we would choose. However, given the increase in transmission rates, it would have been irresponsible and reckless to provide too great a window for increased social mixing and the inevitable increase in transmission that that brings.

Therefore, the Government had to ask people across the country to make further restrictions to their Christmas plans. Although this period has been difficult, we now have clear hope. With the rollout of the vaccine under way, we can start to plot our path out of the pandemic with greater certainty, but it is precisely because of this hope that we cannot give up now. That is why my right honourable friend the Secretary of State for Health and Social Care will make a Statement in the House of Commons later this afternoon, addressing future tiering arrangements in response to the new variant. My right honourable friend the Secretary of State for Education will make a Statement in the other place on the return of schools and universities. The sacrifices we make now are crucial to getting back to normal and ensuring that, next year, Christmas will be much more normal for every family in the country.

I commend the hard work of the NHS teams on the front line, including our Chief Medical Officer, scientists developing vaccines and other therapeutics, and those in the life sciences industry seeking to mitigate the impact of this epidemic. I also express the sympathy of us all to those feeling under pressure of any kind—financial hardship, domestic strife, health concerns, educational worries, mental health pressure or just the worry for loved ones and an uncertain future. To all those, I say that there is light at the end of the tunnel. With new scientific advances being made every day, we are taking concrete steps but, in the meantime, we must dig deep. The end is in sight and, until science can make us safe, it is our duty to put in place these new rules, which will help us to keep this virus under control. I commend these regulations to the House.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I am enormously grateful to noble Lords for an informed, thoughtful and passionate debate. These regulations are incredibly important, but they are clearly not enough to battle the growth of Covid in recent weeks, and the noble Lord, Lord Harris, was entirely right to spotlight the situation in London, which is particularly acute. In Havering, there is a prevalence of 1,500 per 100,000. I remember being surprised when somewhere hit 200, and we used to be happy with 400—1,500 is an astonishing number. I fear that that is what we are looking at, at the moment, and that is the seriousness of the situation we have to face up to.

Some noble Lords have suggested that we are not doing enough, and I will answer a few questions in that area. As noble Lords who have frequently attended these debates will know, we could not have been more committed to our testing regime. In the last reported week, from 10 to 16 December, 92.6% of contacts were reached, 93.9% of pillar 1 tests were within 24 hours and 91.1% of care home tests were within three days. Some 2,293,012 tests were done in that week. That is a colossal number, which reflects an enormous commitment.

The noble Lord, Lord Berkeley, is quite wrong when he describes the project in the Channel Tunnel as chaotic. It was a remarkable achievement, and I do not think that any other country could have pulled it off: 30,000 tests were brought together incredibly quickly on the roadside, with a multinational team of hauliers, under the most difficult circumstances. This helped to get trade moving, and I personally pay tribute to colleagues from the DfT, the military, local police, the test and trace programme and all those who made that possible. I also pay tribute to those who are pulling together tracing partnerships and the community testing regimes over the Christmas period; they have made enormous progress.

A number of noble Lords have quite rightly asked about volunteers and whether we could or should be using them more. I reassure noble Lords in the Chamber that we are absolutely working our hardest to make use of volunteers where we can. A number of noble Lords have asked about administrative problems, and I reassure noble Lords that NHS Resolution has put in place clinical negligence schemes for coronavirus under the terms of the Coronavirus Act, which we debated here at the beginning of the year, and Covid-19 has been added to the Vaccine Damage Payments Act.

NHS volunteer responders have delivered 1 million tasks to 123,455 unique clients; that is the work of 360,000 NHS responders. The St John Ambulance, which has had an absolutely massive impact, has delivered 200,000 hours of support and has very helpfully been involved in training 30,000 people for the administration of the vaccine. It is very much our intention to make use of that valuable resource. Of the 45,000 on the Bringing Back Staff team at the NHS, 2,700 have already been used, and many more will be deployed right now.

In relation to the vaccination, I reassure noble Lords that the authorisation today is a complete game-changer in relation to the scale and speed of the deployment. Not only is the vaccine massively easier to take to care homes, in particular, and GP surgeries, but the change in the dosage pattern means that we can not only deliver every single dose as it arrives in the warehouse but we do not necessarily have to book someone in for an immediate second dose. That gives our deployment programme an enormous amount of flexibility, and will lead to a great increase in our turnover: we will literally be delivering them as quickly as they can be manufactured.

Others are concerned that we are doing too much, and I will address that very quickly. In relation to projections, I have stood at this Dispatch Box and had the projections of the Government, SAGE and PHE derided by noble Lords as fearmongering. Who could possibly have believed that we would have 53,000 new infections? It is a little bit rich of noble Lords to question the work of scientists and our modelling teams in relation to their projections on today of all days. We accept advice from a very wide range of scientists; no voice is excluded. It is the role of government to synthesise advice into policy, and we do not need to smear or deride the scientists who supply that advice.

I have been through the statistics on public support on numerous occasions; I do not think I need to go through that again. There is massive public support for the measures that we have implemented. As for ignoring the Government, adherence rates are remarkably high, and I pay tribute to the public, which, although there are exceptions, by and large are incredibly committed to the regulations that are in place.

Lastly, as I have said before, it is not the Government’s policy to use two-week lockdowns as an emergency brake. These were used in Wales but not nationally, and that will not be our policy.

I agree with the sentiments of the noble Baroness, Lady Watkins—at heart, I also celebrate British liberties, but it is the virus that is not respecting liberty, not government, and we have no option but to bring in these kinds of measures to battle the virus, save lives and protect future generations.

A number of noble Lords mentioned schools, which are, without doubt, the most difficult subject at the moment. Of course it is right that we should do absolutely everything we can to keep schools open. Noble Lords who made that point enjoy my complete and utter support, but the epidemiology is very challenging. Schools have undoubtedly been the source of an enormous amount of transmission. Some of that is asymptomatic, but it is deadly nevertheless. The opening of schools has contributed to the high rate of transmission, particularly in London. It will be up to the Secretary of State for Education in the other place to make the announcement on schools, but the Government are entirely committed to trying to keep schools open for exactly the reasons cited in this Chamber, not least because it is those who come from the poorest backgrounds who undoubtedly suffer most from their closure. However, in order to make an effective regime to battle this virus we may need to make some tough decisions.

The noble Baroness, Lady Thornton, asked whether this is going to be enough. That is not for me to answer; my right honourable friend the Secretary of State for Health will be making a Statement in the other place shortly and he will address the question of any future restrictions or regulations. However, the noble Baroness is entirely right; the challenge we face this week is completely different to the one we had when we went into recess before Christmas. This new variant is of a different order; we may as well be battling a different disease. We will have to step up to that challenge in order to see ourselves through to the spring, when the vaccine will have been delivered to sufficient numbers to make a real difference. I regret that that may strike a chilling note at the end of this debate, but we have to face up to it.

Motion agreed.