Medicines and Medical Devices Bill
Lord Bethell ExcerptsMonday 19th October 2020
(3 years, 11 months ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, I thank all those involved in this first group; indeed, they are the team who, I feel, are likely to be walking with us through a great many groups of amendments. I enormously regret the fact that some noble Lords are unable to make this session, but I thank the usual channels for their efforts in the challenging process of trying to programme the hybrid House, and for finding time for this session, and for the Bill, in a packed programme.
We are starting with one of the most important groups of amendments, which address the principles behind the Bill. I believe that is the purpose of Amendment 1, in the name of the noble Baroness, Lady Thornton, and also her Amendment 140, Amendment 139, in the names of the noble Lord, Lord Sharkey, and the noble Baroness, Lady Jolly, and Amendments 50, 67, 115 and 141, in the name of the noble Lord, Lord Patel.
Although there is some variation in the specific effects of the amendments—such as which clauses they amend and which clauses come under their scope—they all look ahead towards drawing a line under the Bill, whether that be through a sunset clause or by asking the Government to return with consolidated legislation.
I emphatically believe in the Bill. I have listened to the criticisms of the Delegated Powers and Regulatory Reform Committee, and noted the comments of the noble Baroness, Lady Thornton, and the noble Lord, Lord Patel. Those points have been powerfully made in the report, on Second Reading and here today.
I know that the report may have inspired some of these amendments, because the committee considered sunsetting the Bill to be an appropriate response—but only if the Bill had remained as previously drafted. However, as your Lordships know, I have engaged extensively with noble Lords on these matters, and have tabled many amendments to address the specific concerns that we are debating today.
A sunset clause, reviewing these matters again in two or three years’ time, will not change the very good reasons why delegated powers are necessary. It would be an unhelpful precedent, which could lead to a rolling review of all legislation. My noble friend Lord Lansley, a former Leader of the House of Commons, and my predecessor, my noble friend Lord O’Shaughnessy, both made that point very powerfully.
The noble Lord, Lord Patel, is right to say that clarity is important, but that will come through consultation. As I respond to this point, and to my noble friend Lord O’Shaughnessy and to the noble Lord, Lord Sharkey, it is worth remembering that we have published six illustrative SIs—so it is not true that we have provided no examples of how the powers could be used. I want to ponder on this well-made thought, and give further thought to how we might go further. It is hard to see how sunsetting the whole Bill would bring additional clarity to the situation.
Returning to first principles, particularly patient safety, we need to react quickly and effectively to harm. Taking swift action, such as making changes to how medicines can be administered in the community—as we are doing in relation to the Covid vaccine—is absolutely necessary when the situation requires it. So sunsetting Clauses 1 and 12 would mean also sunsetting Clauses 6 and 15. We would have no emergency provision at all until that could be replaced—a regulatory cliff edge that I would find difficult to explain to patients who needed that flexibility to get the necessary treatment.
Harm can be also significant and require more fundamental regulatory change. The report of the noble Baroness, Lady Cumberlege, suggests that the system has been slow to move and respond, and that patients have not been heard. We cannot predict or pre-empt every risk of patient harm that will emerge. Patient safety cannot wait for primary legislation. When new measures have been introduced—such as databases of medical devices under Clause 16—I cannot think why we would want to go backwards. Saying that we should no longer be able to track and trace patients, nor be able to update the data types that should be recorded to protect patients, does not make sense. Using measures in the Bill such as the information system in Clause 16, we will do better for UK patients. This is not only what the Government want but what patients want. I hope that such a system will mean that the Government will know which patients have been affected by which specific device so that they can avert problems in future.
Secondly, the changes range on a scale from significant to relatively minor, for which primary legislation would be inappropriate. For instance, changing labelling to include pictograms is not a matter that needs to wait for a future Bill.
Thirdly, this is a modern and fast-changing industry, as the noble Lords, Lord Hunt and Lord Kakkar, put it so well. In two or three years’ time, we may still need to preserve our ability to amend and update regulations. We will need to provide confidence to businesses, patients and other parties that the statute book will keep pace with change. While much will be said on the attractiveness of the UK, this is a very real issue.
In response to the comments of the noble Baroness, Lady Thornton, on the benefits of a new round of consultation, perhaps even more serious is the fact that two or three years is simply not enough time for all the regulatory changes to take place—especially when we are obligated to consult all the people that noble Lords will identify when we come to that debate. Bills take time. This Bill was announced last year and was introduced in February. We are not there yet. We simply did not have enough time to judge its efficacy before we had to write it again.
On noble Lords’ amendments seeking to consolidate the legislation made in under three years, I say this: the Human Medicines Regulations were the consequence of a consolidation exercise. The Medicines Act 1968 was originally the method for regulating the way in which medicines were licensed for use in the UK. However, a number of changes were made over the years through regulations, which Parliament approved, to regulate medicines under that Act better. As such, the Human Medicines Regulations were meant to provide exactly what the noble Lord, Lord Patel, asked for: streamlined legislation that places regulatory matters in a single set of regulations.
Nor was there a lack of consultation on this approach. At the time, the MHRA took action to draw on stakeholder views and a formal consultation was run in late 2010. Parliament considered it appropriate to redirect into secondary legislation regulatory matters that required frequent changes to respond to potential safety concerns or changes in how medicines might be produced. The MHRA indicated that, should further consolidation be needed, this could be revisited. The noble Lord asked me whether there are ways of considering consolidation in the future. I must listen to him but, again, I say that three years is not a very long time at all for regulatory changes.
We recently published guidance for businesses that sets out the expected arrangements for the end of the transition period, in order to provide enough time to bring forward a standalone regulatory system and give businesses time to comply. That period of standstill will run for two and a half years; in that context, it is unlikely that, in the space of two years, there will be regulatory change that is so significant that it requires consolidation.
If your Lordships seek assurance on the visibility of how the Government will make regulations, or if your Lordships are asking me to specify our plans for how quickly we might move to the current regulations inherited from the EU, let me say this: we do not intend to make changes for the sake of it. We will do what is in the UK’s best interests. Whether our choices mean that our regulatory framework is similar to or different from regulations made by the EU does not change that approach. Regulations, rather than primary legislation, are the appropriate vehicle to protect patients best. Changes will be made subject to public consultation, and the amendment that I have tabled—on reporting obligations—will enable Parliament to consider and reflect on the Government’s use of powers in plans.
I am listening. I have proposed changes to improve the Bill—we will come to those later, having reflected on the debate—but I will face a real challenge in the new year as a result of the gap that will open up at the beginning of January if this Bill is not finished by then. I would not want to put in my place another Minister for Innovation who might also need swift regulatory change for UK patients, whether that is getting medicines approved quickly or changing who can administer them.
I hope that the noble Baroness has heard enough to reassure her and that she feels able to withdraw Amendment 1. I hope that other noble Lords with amendments in this group do not feel the need to move them.
The Deputy Chairman of Committees (Lord Lexden) (Con)
I have received a request to speak after the Minister from the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, I am grateful to the Minister for his response and, to a degree, his assurance that he is at least prepared to look at ways to consolidate the legislation. I do not accept his point about time. We are not asking that this Bill be held up; we are asking that the Government consider over the next three years bringing in legislation to consolidate the current legislation.
I am also grateful to the noble Lords, Lord Lansley and Lord O’Shaughnessy—both of whom are experienced in dealing with matters related to medicine in their own right—for their comments and support. I hope that, in the debate on the next group of amendments, the Minister will confirm in a more tangible way how he will address this issue because when we discuss those amendments, we will have an opportunity to come back to what he has said about the government amendments.
Lord Bethell (Con)
My Lords, I hear the noble Lord, Lord Patel, very clearly. The arguments that he made during our conversations and engagement earlier were powerful. The comments made by my noble friends Lord Lansley and Lord O’Shaughnessy, one of whom is my predecessor and one of whom is a former Health Secretary, were also extremely persuasive.
The Government do not think that putting consolidation in the Bill is wise, but we hear the points made by the noble Lord, Lord Patel, loud and clear. We would definitely consider this matter at a future date if the arguments made were persuasive and agreeable.
Baroness Thornton (Lab)
My Lords, I thank all noble Lords who took part in this preliminary and important debate on the Bill.
The noble Lord, Lord Patel, made an important point concerning primary legislation after three years. The Minister seemed to suggest that three years is not long enough. That cannot be right; three years is certainly long enough. Without the principles and policy that my noble friend Lord Hunt spoke about, rule by regulation is not only inadequate but probably quite dangerous. That lies at the heart of this group of amendments.
The noble Lord, Lord Kakkar, made the important point that we have a well-designed regulatory framework in the UK; this amendment is not about disrupting that. He also said that the Bill should be about improving the framework; that is exactly right.
Lord Bethell
“(1A) The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”
Member’s explanatory statement
This amendment provides that the appropriate authority may only make regulations under subsection (1) of Clause 1 if satisfied that they would promote the health and safety of the public.
Lord Bethell (Con)
My Lords, Amendments 2, 7, 51, 54, 56, 68 and 72 are a package intended to respond to the comments made at Second Reading and the consideration of the Bill by your Lordships’ Delegated Powers and Regulatory Reform Committee and the Constitution Committee.
I have said at both the Dispatch Box on Second Reading and in meetings with a number of noble Lords that I am listening and ready to make improvements to the Bill where they are necessary. I am ready to provide reassurance about how the powers are intended to be exercised. Amendments 2 and 68 would require that regulations may be made only if the appropriate authority is satisfied that the regulations promote the health and safety of the public. A number of noble Lords spoke in favour of clarity regarding how the considerations applied in making regulations and whether the first consideration—that of safety—had primacy. This was a point made by the noble Baronesses, Lady Barker, Lady Andrews and Lady Walmsley, and by the noble and learned Lord, Lord Woolf. Their remarks on how the Government could improve the nature of the framework Bill were ones that I paid particularly close attention to. In making legislation, there is a delicate balance between making it absolutely clear that regulatory change will not be made that is contrary to promoting the health of the public and not binding the Government so completely that necessary regulatory change that is not explicitly for the purpose of promoting the health of the public is not possible. This amendment seeks to provide that comfort: that the Government’s making of regulations must satisfy that obligation.
Amendment 51, on veterinary medicines, is drafted differently to reflect the specific circumstances of how veterinary medicines are made. For example, a medicine that might be suited to the health of an animal might unhelpfully contribute to antimicrobial resistance in humans. An overarching requirement to be satisfied that regulatory change promotes the safety of animals, without reflecting that we must also consider the safety of animals as food products in the food chain, would have inadvertent consequences. Amendments 7, 54, 56 and 72 are consequential to these.
I have considered carefully the alternative constructions tabled by your Lordships. I wanted to demonstrate our absolute commitment to patients’ health and safety that is at the heart of this Bill. My noble friend Lady Cumberlege’s report has highlighted the importance of this.
My amendments do not fetter our ability to make good regulations that will enable the development of new medicines and devices in the UK and ensure the availability of those medicines. But, in doing so, the requirement to be satisfied will protect against the inadvertent impact on the health of the public. This will answer the requirement to make it clear how the Bill is a framework Bill, as opposed to a skeleton Bill, providing that test against which regulations can be measured.
I hope that these amendments provide assurance not only to those in this House who sit on the Delegated Powers and Regulatory Reform Committee and the Constitution Committee but to others who are keen to see the Government reflect my noble friend’s recommendation that patient safety be put first. I beg to move.
Lord Lansley (Con)
My Lords, I am glad to have this opportunity to speak to my Amendment 5 and to Amendments 70 and 76 in this group. I am particularly grateful to the noble and learned Lord, Lord Woolf, and the noble Baroness, Lady Jolly, for putting their names to Amendment 5. As the Minister rightly said, he set out to respond in government Amendment 2 to the remarks of the Delegated Powers and Regulatory Reform Committee and the Constitution Committee. We discussed this a lot at Second Reading. The essence of the argument that I among other noble Lords made was that the Bill was a skeleton, the skeleton approach was criticised by the Delegated Powers Committee and we needed to move it from a skeleton to a framework by making it clear that the power to make regulations is for a purpose. The noble and learned Lord, Lord Woolf, and I set out to do that in our amendment: to express a purpose rather than have a power that essentially had no test other than whether the Secretary of State had had regard to certain factors—there was no objective test that could be examined, because it is very easy for Ministers to say that they have had regard to something.
Why did we have the objective of safeguarding public health? The relevant EU regulation, which is the EU human medicines directive 2001/83/EC, as amended, says at what is essentially its first article:
“The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.”
Therefore, rather than invent our own purpose, we thought that the starting point for the legislation should be to reflect the same objective as incorporated into the regulation-making power up to now. The Minister may well say, “But the EU regulation is not only based on the public health treaty objective but on the internal market objective”. However, Article 3 of the EU regulation, which follows that, is quite clear:
“However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.”
Therefore, the other legal bases, if anything, tend to act alongside and be balanced with the original treaty objective, which is to safeguard public health. It seems that there is therefore nothing inherently wrong in our own power to set out the objective, which is to safeguard public health, and then to set alongside it in the subsequent subsection the other considerations to which the Secretary of State must have regard. We will go on to discuss those, but they include the safety of human medicines, the attractiveness of the UK as a place to conduct clinical trials, and so on.
This is the test: why are we moving from the current legislative basis to a new one? What is inherently better in saying that Ministers must be satisfied that they will promote the health and safety of the people and in what sense is that different from safeguarding public health? Noble Lords might well say, “You have won—you put your amendment down and the Minister has put government Amendment 2 down, and they say more or less the same thing”. We submit that they do not quite say the same thing, since the government amendment’s construction is that the Secretary of State “must be satisfied that”. Our construction is that it
“must have the objective of”.
I am not qualified to say any more about this matter; I will leave that to my noble friend in this regard, the noble and learned Lord, Lord Woolf. An objective test should be expressed in the legislation in objective terms, not in subjective terms of whether the Secretary of State is satisfied.
Amendment 70 does a similar thing in relation to medical devices. Amendment 76 begs the question: is the safety of a medical device to be assessed in the absence of knowing its therapeutic use? It may well be that the answer is that assessing the safety of a medical device must necessarily consist not only of the approval process but of understanding its use in therapeutic settings. If the answer is that that will necessarily be the case and if Clause 12 of the Bill means that anyway, I am perfectly happy to accept that. However, I am looking for an assurance from the Minister that that is what Clause 7 means: safety of a medical device is not simply through its approval processes but through understanding in the approval process how it will be used in therapeutic practice.
In conclusion, from what I have said we do not think that government Amendment 2 is better than our Amendment 5. However, government Amendment 2 is clearly better than what is in the Bill at the moment, because it gives us a purpose for which the regulation-making power is to be used. I make a plea to noble Lords. At this stage, in Committee, I would far rather change the Bill by accepting the government amendment and its sequelae, as we would say, and therefore send the Bill to Report in at least a form that one Front Bench agrees with than not change the Bill and have to have this same debate all over again on Report. We might have the same debate, but it would clarify for the benefit of noble Lords on Report if at least the Bill has moved from where it has been to show how the Government are seeking to meet the objectives set out at Second Reading and by the Delegated Powers Committee so that we can look at it again properly on Report. I of course reserve my position and that of my noble friends whose names are attached to this amendment, as we might well want to come back to the issue on Report and say that our formulation with an objective test is better than the subjective test that government Amendment 2 implies.
Baroness Thornton (Lab)
Like the noble Lord, Lord Sharkey, I shall have a minor moan. It is normal practice to give fellow Peers sight of government amendments at least on the day are put down, so even though the Bill team had not managed to discuss their intention with Opposition parties and other noble Lords involved in Committee, we received the letter from the Minister explaining the amendments on Thursday. I hope the Minister and the Bill team will not continue to leave things so late. I remind the Minister that he has a whole Bill team and a department at his disposal. Other noble Lords write their own speeches, do their own research and need more time to give amendments due consideration. I am fortunate to have some excellent support and we work very hard on our side to get our amendments down as early as possible to give other noble Lords the opportunity to consider them and discuss them with us. The Government should always bear in mind the unequal nature of resourcing in this place.
We need to see these amendments for what they are. Of course, they are mostly worthy and we welcome the improvement, but essentially, to echo the words of the noble Lord, Lord Patel, they are there to placate and circumvent. We are late in the day in beginning to understand the nature of these amendments and we now understand the urgency of them as a result of our earlier discussions, for which I thank the Minister and his team. We are waiting for reassurance from the Minister about what happens at the next stage.
The noble Lord, Lord Lansley, made some very important and pertinent points, particularly about the difference between the objective test and the subjective test. It is clever and very important. He is on the side of objectivity and the Government’s amendments are definitely on the side of subjectivity. I agree with him that Amendment 2 is not as good as his Amendment 5. The noble and learned Lord, Lord Woolf, also said something very pertinent and quite correct about not giving blank cheques. He accepts what the Government are offering, but made the point that further discussions are needed and an amendment might be needed as we move forward.
I say to the noble Lord, Lord O’Shaughnessy, that I do not have a principled objection to government amendments coming forward; it is just that we need to know the context for them. The noble Lords, Lord Lansley and Lord Kakkar, and others, including the noble Baroness, Lady Jolly, made a very important point about safeguarding public health, and I hope the Minister will be able to address it. I can probably feel an amendment coming on on that one.
Lord Bethell (Con)
My Lords, I am enormously grateful to my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, for Amendments 5 and 70. I greatly appreciate their scrutiny and contribution on the way in which regulations under the Bill might be made. I am grateful to my noble friend for his constructive dialogue with my officials. His experience and expertise in making legislation on health matters is a real benefit to all of us.
My noble friend and the noble and learned Lord, Lord Woolf, have drawn on the framework of legislation in the EU context. I am grateful for their explanatory statement on the basis of the amendment. My noble friend knows that I pressed very hard to see whether this is something we could accept. The challenge your Lordships have set me is why, if this framework exists in EU legislation, is it too constricting for the Bill? The answer is that examples of significant recent EU legislation in relation to human medicines, clinical trials and medical devices include: directive 2001/83/EC, regulation 726/2004, regulation 536/2014, and regulation 2017/745. In other words, while citing the aim of safeguarding public health in Article 168, on public health, of the Treaty on the Functioning of the European Union, these pieces of legislation were also made in reliance upon Article 114 of the treaty, being measures for the approximation of laws which have as their objective the establishment and functioning of the internal market. To make that point again, safeguarding public health is not the only objective of the EU legislation in relation to medicinal products and medical devices. That is why we have a challenge in this area and why we have posited our amendment.
I shall say something about the other government amendments, specifically replying to the noble Lords, Lord Hunt and Lord Sharkey, and other noble Lords who commented on them. The overall timing of the Bill means that currently, it cannot reach Report any earlier than mid-November. If we start the consent process with Northern Ireland then, it will add a minimum of two months past the end of the Bill’s timeline. To explain to the noble Lord, Lord Sharkey, we need to start the consent process now in order to make further changes. The Government need to demonstrate that this is a policy they wish to make in order for Northern Ireland to get that process properly under way. We have written to Northern Ireland seeking consent to make changes. Parts 1 and 2 of the Bill are transferred to Northern Ireland. I sought consent from Northern Ireland on the Bill as a whole when the Bill was introduced, and again after the change made on Report to Clause 16.
We sought to make government amendments at the earliest opportunity to respond to the DPRRC, partly to demonstrate how significantly we take that report and partly to start this process. That process has now started, but it has not concluded. It does not preclude noble Lords from further consideration and, as my noble friend Lord Lansley, indicated, the Bill has moved. The process of consent is unavoidably three months long in order for the Northern Ireland Assembly to conduct its work. That is why we have had to start now. In reply to the noble Lord, Lord Hunt, I can supplement the legislative consent Motion at a later date.
I will listen. I understand and acknowledge that the noble Baroness sees this as the beginning, not the end, and I acknowledge that she will return to the issue on Report. Accepting these amendments today does not prevent her doing so, and I will continue to listen.
I completely hear what the noble Lord, Lord Hunt, says about engagement with the MHRA. I would be glad to arrange a suitable engagement with June Raine from the MHRA and parliamentarians to discuss these points.
To the noble Lord, Lord Patel, I confirm that the efficacy of a medical device is assessed as part of the process of obtaining a CE certificate. The therapeutic value of a device is not part of the CE certificate assessment; that is a function carried out by NICE. On the point made by the noble Baroness, Lady Barker, on the food chain, I would be glad to arrange a follow-up discussion on the veterinary medicines directorate with the relevant Defra Minister. To the noble Baroness, Lady Jolly, Defra and BEIS are content with this amendment. To the noble Baroness, Lady Walmsley, the medical devices section of the overarching bit at the beginning of the Bill is a carry-on from the sentencing enforcement, and in Part 3 enforcement is in relation to medical devices only. I do not think these are reasons to rewrite the purpose.
I obviously hope to win the argument on some of this, but that will come from extensive engagement and thorough communication going forward, for which I thank noble Lords. I therefore hope that the noble Baroness feels able to accept these reassurances, and I am grateful that my noble friend considers this sufficient reassurance not to move his amendments.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I have received a request to speak after the Minister from the noble Lord, Lord O’Shaughnessy.
Lord O’Shaughnessy (Con)
I thank my noble friend for addressing the point about therapeutic use, but I think I am slightly more confused now than I was before. He talked about NICE, but of course, NICE does not assess every medical device and assesses from a health economics perspective, as opposed to a purely regulatory, safety and efficacy perspective. It is not something that need detain us, but perhaps he could follow up afterwards with a bit more detail.
Baroness Jolly (LD) [V]
It was almost inevitable, looking at the amendments that were coming up and knowing the people who would be discussing them in Committee, that this was going to be one of the most interesting debates. It has been fascinating and well informed. The amendments relate to our future relationship with the EMA and other international organisations after Brexit. My Amendment 125 in this group is on future regulatory alignment; I am grateful to my noble friend Lady Sheehan for her contribution.
The Government have not been forthcoming on whether they will pursue regulatory alignment and, more importantly, what the implications of not doing so would be. I would be grateful if the Minister clarified that second point. Our clinical trials are hugely important and widely respected. The clinical trials information system is critically important; the noble Lord, Lord Lansley, made that vital point. What aspect of the role of the EMA are we trying to replace? It has four parts: to facilitate development and access to medicines; to evaluate applications for marketing authorisations; to monitor the safety of medicines across their life cycle; and to provide information to healthcare professionals and patients. We need urgent clarification on how the future information system will work, who will host it, how it will be staffed and how we will share our research.
As the noble Lord, Lord Patel, said, we do not have a large enough population for significant research without partners. Are we clear that we could work with the FDA in the US—or, indeed, with the TGA in Australia? Would that give us a sufficient body of people from which to take on our research? Perhaps. Are there any moves to seek full membership of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use? I am sure that the Minister will have the answers but the regulations must have regard to the desirability of alignment, somehow or other, with the rest of the world. We cannot work as a small unit—perfectly formed, maybe, but we are small compared with the US, Europe and other groupings.
How is this going to be measured and monitored? The noble Lord, Lord Hunt, spoke about the fast-track licensing of medicines and devices. The point he made so clearly is that public safety has to be paramount so we cannot rush this sort of thing. We have to get it right; if people have to wait, so be it. It has been interesting to hear the reflections of the noble Lord, Lord O’Shaughnessy, because he was sitting in the hot seat of the department. I wonder whether he is glad that he is not there now.
The other interesting amendment concerns the definition of attractiveness, which included collaboration with the EMA. The noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Finlay of Llandaff, attempted a definition. I am sure that if we were all given a piece of paper and asked to write down our definition of attractiveness, there would probably be as many answers as there are people in the debate today. I would like a definition from the Minister: how is this to be measured and by which body?
Without a doubt, under the provisions of Amendment 34, regulations must be made, while under Amendments 35 and 36, they should correspond with the EU clinical trials regulations. Amendment 38 provides that we must continue our collaboration with the EU in whatever form we can manage between us. We also need to look hard at clinical trials portals, not only with the EU but with our other partners in future.
Lord Bethell (Con)
My Lords, as the Minister for Innovation, I am very keen on the UK’s continued leadership in this area; I have made it something of a personal cause. I am very proud of the fact that the MHRA approves around 950 medicinal trials a year, over half of which are multinational.
We know that once an early phase trial is established in this country, the industry is more likely to keep its later phase multi-country trials here. I would say to the noble Lord, Lord Hunt, and others who have questioned this point, that I can confirm that the purpose of the measures in this Bill are absolutely to build on our established strengths so that the UK has the opportunity to anchor international drug development in this country and grow that capability. I am committed to international standards, international partnerships and multi-country clinical trials. It is of course important that we work with our international partners both within the EU and globally to the benefit of patients. I assure noble Lords emphatically that we are committed to international co-operation.
However, I do not agree that our future relationships will be furthered by mandating the consideration of alignment with EU regulations and the European Medicines Agency. The UK has a long track record of jointly tackling global challenges with strong international links already in place between research and innovation communities. The UK works closely with many other regulators; those relationships are underpinned by many shared international standards. The EU bases its regulations on exactly those standards, as do we, and we will continue to do this going forward.
As a number of noble Lords have noted, we have the opportunity to create a better regulatory framework. The feedback from the industry is that an agile, proportionate UK system with familiar data submission requirements would increase the UK’s attractiveness as a place to conduct multinational studies, even if we are operating outside the EU’s network. My noble friend Lord O’Shaughnessy’s quote from the ABPI made this point. The powers in the Bill as it stands will allow us to develop exactly that kind of system.
Progress is already happening. The MHRA and the Health Research Authority are already taking steps to streamline the approvals process for UK clinical trials and are currently piloting a new process that has been shown to reduce overall approval times by more than 30%. I say to the noble Lord, Lord Sharkey, that this change does not rule out co-operation. Data generated in a UK clinical trial will continue to be admissible to support regulatory activity in the EU—and, indeed, globally. We can also look at how we can go further in making clinical trials and their results transparent and visible to the public. Co-operation does not require alignment.
Amendment 3 in the name of the noble Baroness, Lady Thornton, also suggests considering alignment with EU licensing processes. In the short term, the MHRA has already taken steps to recognise for two years future EMA decisions for medicine licences approved through the centralised authorisation procedure from January 2021. In the long term, there are opportunities to establish new UK routes to market, such as a new expedited pathway for innovative products, and to establish shorter assessment timeframes.
We have the ability to make corresponding or similar provisions to the EU CTR, but Amendment 38 would oblige us to align. Amendment 35, in the name of my noble friend Lord Lansley, does something similar. My noble friend makes the point that we have the opportunity to do better than the EU CTR, and that is very much our intention. That regulation replaces current separate regulatory authority and ethics approvals with a single national decision for a trial. The UK could adopt a similar methodology and associated data requirements for approvals, but in a much quicker timeframe. We have already introduced the combined ways for a working pilot to streamline approvals by the MHRA and ethics committees, and industry has told us that our scheme is one of the most appealing among the various pilot schemes in the EU, leading to a reported 30% reduction in timelines. The UK may wish to go further and develop our existing national system to further adapt requirements according to risk so as to reduce unnecessary burdens, such as academic trials involving a marketed product already in common usage.
In his Amendment 49, the noble Lord, Lord Sharkey, suggests that there would be benefits in adopting certain definitions in the EU CTR. These include the EU’s revised definition of a clinical trial and co-sponsorship set out in the EU clinical trials regulations. Under the EU CTR, this new definition of clinical trials is an attempt to avoid current variation in interpretations in different member states. Whether this will have the intended effect remains to be seen. EU legislation already includes a definition of a clinical trial, and the MHRA offers trial sponsors free advice on whether their study meets that definition, to ensure a consistent interpretation. If we wished to amend our definition of a clinical trial corresponding to that in the EU CTR, the Bill as drafted would enable that.
My noble friend Lord Lansley is right that the EU CTR introduces a single submission portal and co-assessment model, but I confirm that member states involved still have to individually authorise the trial, and therefore one or more member states could refuse authorisation. The portal is an IT system, the method of delivery. This does not mean centralised EU approval of a trial. Where a member state has national restrictions that require separate approvals outside the scope of the EU CTR, the sponsor would still have to seek the approval separately of the individual member state, in addition to the processes for seeking authorisation for the trial through the EU portal under the EU CTR. Industry has told us that if the UK has a rapid approval system, the lack of access to the EU portal is not a particular issue.
Amendment 52 introduced by the noble Lord, Lord Patel, suggests provision to develop a clinical trials portal that aligns with the European Medicines Agency for medicines for rare diseases. The EMA’s IT system does not address complex trial designs, such as umbrella, basket and platform trials that involve the use of master protocols. These are the very trial designs that have delivered the UK’s successes in Covid-19 research. On the EU portal, it is also extremely unlikely that the EU would agree to UK involvement, even if one were to request it, given that it is for EU member states and EEA countries. There are many other reasons why the UK is such an attractive place to run global rare disease trials: our world-class research infrastructure and centres for excellence, and so on and so forth.
Lord Patel (CB) [V]
My Lords, the Minister referred to the large number of trials that are started in the United Kingdom. Can he say how many phase 3 trials have been started here? He also referred to the platform that the MHRA has developed with regard to Covid that accelerated the delivery of drugs, which is correct. However, that is not the same as a platform for rare diseases.
I agree that the licensing that was done at speed, within six months, would normally have taken two years: for instance, the licensing of the use of Remdesivir, produced by Gilead Sciences for the treatment of Covid-19. However, that is not the same as the noble Lord’s implication that it could be used for rare diseases. Those require a larger database, which Covid had, because there is no shortage of Covid data. Furthermore, he said that the EU portal means that individual countries have to approve. That is correct, but the approval is a speedier process because it has gone through the portal, unlike before.
Lord Bethell (Con)
My Lords, I will be happy to write to the noble Lord with the precise figures for phase 3 trials. However, he is right that they are incredibly important. The Bill must defend our position on phase 3 trials, which are very much the sharp end of the clinical trials process.
The learning from RECOVERY is that it is not a direct read-across to rare diseases. The noble Lord is right that in rare disease trials, we are often trying to drill down into very small communities, whereas 113,000 signed up for RECOVERY, and tens of thousands took some of the drugs that went through the trial process. However, it is the general capability of being able to run significant platforms, manage ethics at speed, get regulatory sign-off for these trials, and have a clinical trials regime which suits many different purposes. That is our objective, that is why we are putting through these reforms, and that is why we believe that the Bill can support a modernisation of our clinical trials regime.
On the European trials process, the noble Lord is entirely right that the portal contributes to speedy processes. However, it is not the only way of having a speedy sign-off of trials through Europe; we believe there are other ways of doing that.
Baroness Thornton (Lab)
Responding to the very last thing that the Minister said, he will have to tell us what those other ways are during the course of this discussion.
This has been a well-informed debate, as I assumed it would be. I think I was right in saying that this issue is at the heart of the Bill and how we move forward. My noble friend Lord Hunt—I thank him for his support —was quite right that this is the big issue. As the noble Lord, Lord Sharkey, said, this is the start of the discussion that we are going to have about attractiveness and where that lies and how it can express itself.
The noble Lord, Lord Lansley, put his finger on various important issues to do with clinical trials. He asked the key question, which I do not think the Minister answered. It is: if we diverge, what will that mean and how will it happen? I did not hear an answer to that question. The answer will determine what some of us do next as we move forward with this Bill. The noble Lord, Lord Kakkar, was completely correct when he said that it is vital that we get this right for the future of life sciences in the UK.
I am grateful to the noble Lord, Lord Patel, for his support for our amendments. He reminded us that we had this discussion during the passage of the main Brexit legislation, when we were told that it was not the appropriate place to such a discussion so the amendment was withdrawn. Now, at the last minute, this must be the place where we have these discussions and come to some conclusion on them.
The noble Lord, Lord O’Shaughnessy, is right. As we strike out on our own as a country, we will need new relationships and we will need to take advantage of what is on offer in the rest of the world. The transition will be very important because what happens in the meantime is vital. We will also need to ensure patient safety in this laissez-faire world, as the noble Lord explained, for example, if we decide to ignore the portal and strike out without it.
I do not doubt for a moment the Minister’s emphatic commitment to making this a success, but as we move forward, this Committee will need to understand much more than what the Minister has told us so far on the risks and opportunities. My final request to the Minister is that we will need a cross-party meeting of some depth—possibly more than one—to discuss this matter with his Bill team and the MHRA. We had such a meeting. It feels as if it was aeons ago, but I think that it was in February, perhaps March. Anyway, it was before we went into lockdown. We absolutely will need meetings and discussions before we move on to the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.
Lord Bethell
Member’s explanatory statement
This amendment requires the appropriate authority to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 1 in considering whether regulations made under subsection (1) would promote the health and safety of the public.
Health Protection (Coronavirus, Local COVID-19 Alert Level) (Very High) (England) Regulations 2020
Lord Bethell Excerpts(3 years, 11 months ago)
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Lord Bethell
That the Regulations laid before the House on 12 October 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, these regulations, which were made on 12 October and came into force today are necessary owing to the continued rise in the national transmission rates of coronavirus in England. They form a critical part of the government response to the ongoing threat to public health posed by the coronavirus epidemic.
The new local alert level approach, announced by the Prime Minister on Monday, will rationalise the important programme of local interventions that have been applied across the country. It will enable a coherent set of interventions across England, making it easier to communicate to the public which restrictions apply in their area. This will increase the likelihood of compliance and the effectiveness of social distancing measures.
Today we are debating three sets of regulations: very high, high and medium. The regulations in this debate set out the restrictions that will apply when the local alert level category is set at very high. These will apply when the local alert level category high measures cannot contain the virus or where there has been a dramatic rise in the transmission rates. There is no automatic trigger for an area to move into higher restrictions. Government, working with local authorities and directors of public health, will consider several factors, including the number of cases in the area, the rate of transmission, the effectiveness of current interventions, hospitalisations, the national picture and an assessment of the capacity of local health services.
Regarding restrictions on gatherings, in areas subject to local alert level very high restrictions, social contact will be reduced to break potential chains of transmission. For that reason, meetings in indoor venues and private gardens is limited to a single household. Meetings in outdoor venues are limited to a single household unless exemptions apply. The intention is to dramatically reduce social contact while balancing the social and well-being benefits of meeting family or friends. We recognise the risk of isolation, and have taken targeted policy interventions to mitigate this. For instance, a single-adult household and one other household of any size may link together to form a support bubble. A gathering that is made up of people from the same bubble is not subject to the six-person outdoor limit or the one-household gathering limit that applies indoors and in private outdoor settings.
The Government recognise that both weddings and funerals are significant life events. As such, the following higher limits apply to balance the need for people to recognise these significant events, while minimising the spread of the virus: weddings and civil partnerships are subject to a 15-person limit; funerals are subject to a 30-person limit; and wakes are limited to 15 people.
The restrictions placed on business seek to balance reducing social contact and enabling businesses to continue operating to minimise disruption to the economy. We know that hospitality poses a high transmission risk. PHE data shows that, between 3 August and 27 September, 148 known outbreaks occurred in restaurants and food outlets. PHE’s weekly surveillance report also highlighted that, from 21 to 27 September, 13% of those who tested positive for Covid-19 reported eating out in the time before symptom onset, when there is a high risk of asymptomatic transmission. The Scientific Advisory Group for Emergencies has also highlighted that alcohol consumption may increase risk of non-compliance with social distancing and that hospitality settings are associated with increased risk of transmission.
At alert level very high, businesses and venues must follow the restrictions imposed at local alert level medium and high. This requires the closure of all hospitality and leisure venues from 10 pm to 6 am. In keeping with the restrictions on businesses and venues at alert level medium and high, hospitality settings in alert level very high must only use table service for the consumption of food on their premises. This is to reduce the potential for social mixing of customers from different households.
The regulations require the closure of services that pose a higher transmission risk and cannot currently be opened safely. These include nightclubs, dance halls, discos, sexual entertainment venues and hostess bars. The Government are conscious of the impact that this will have on these sectors and we continue to work with representatives from these industries to develop options to facilitate a safe way for them to reopen.
We know that alcohol consumption results in reduced compliance with social distancing rules. These regulations mandate that hospitality venues can only serve alcohol for consumption on the premises alongside a main course meal. Those venues that do not serve main meals must close.
Key to our approach is financial support. Businesses that are required to close will be eligible for support from the Local Restrictions Support Grant. Eligible businesses will receive a grant for each two-week period they are required to close, payable after the first two-week closure period.
In addition, the Job Support Scheme will provide a safety net for businesses across the UK required to close temporarily. The Government will support eligible businesses by paying two-thirds of each employee’s salary up to a maximum of £2,100 a month.
Given the likely impact of the new measures introduced in very high alert level areas, it is important that local areas shape the restrictions introduced and that the restrictions reflect the local, economic, social and public health situation. The Government will work with the respective local authorities to achieve this.
The regulations create offences punishable by fines and provide for fixed penalty notices. I pay tribute to the vast majority of the general public who are doing the right thing and diligently following the rules, but it is vital that the police have appropriate powers to deal with those who do not.
I appreciate that these changes have caused real disruption to people’s lives. However, the evidence continues to indicate that the infection rate is rising across the country. It remains vital that the Government take decisive action to limit further spread. For that reason, I beg to move.
Amendment to the Motion
Lord Bethell (Con)
My Lords, I am enormously grateful to noble Lords for an incredibly thoughtful debate about measures that were laid only recently and have come into force today.
I start by addressing the two big, chunky issues that were raised by noble Lords. The first is the connection between Test and Trace and local efforts on the ground. I want to take a moment to reassure noble Lords about our commitment to a really strong connection between the national efforts of our test, trace and isolate programme and the work that goes on on the ground. Test and Trace and Public Health England work incredibly closely with the Association of Directors of Public Health, the Society of Local Authority Chief Executives and Senior Managers, the Local Government Association and UK chief environmental health officers as part of this programme. Those conversations happen daily on an institutional and personal basis.
The challenge was put to me that the contact tracing does not include public health experts. That is not quite right. There are 1,000 tier 1 contact tracers working within the core contact tracing service and in health protection teams and field services right across the country. More recruitment is under way. In fact, we have more than doubled the size of local health protection teams since the pandemic began, precisely because of our commitment to the partnership between the national and local efforts.
It was suggested that we should do more to work with local clinicians. We do an enormous amount of work with local clinicians. Thousands of NHS clinicians have signed up as contact people. They are in touch with those who have tested positive and talk them through the process to find out where they have been and who they have been in contact with. They do an incredible job every day and are the expert bedrock of the contact tracing process.
We absolutely depend on and mobilise local know-how, which we do through data sharing. Local public health officials can use the data provided by NHS Test and Trace to follow up cases that the national service has been unable to reach. Together, we can increase the numbers who are reached. More than 90 local authority partnerships across the country have gone live with locally assisted contact tracing, and more are coming on every week. The results are enormous. In England, we have reached more than 650,000 people and advised them to self-isolate. Everyone who tests positive is contacted by Test and Trace.
On the testing service, we are doing 310,000 swabs a day—22 million tests in all. There are five Lighthouse labs, 96 NHS labs and a total of 500—I repeat, 500—local testing sites. As a result of the tracing numbers, last week, 51,000 people tested positive, 34,000 of whom went into the contact system—and we should bear in mind that many would have been in the care service and therefore do not need to be transferred. Of those, 25,000 were reached and it was suggested to 21,000 that they isolate. Without that system, the epidemic that we have today would be worse than it is, and we owe enormous thanks to those involved.
A number of noble Lords asked about the app. There have been some 16.9 million downloads. That is 29% of the over-16 population, and the costs up to 31 July were £13.8 million. We are completely live to the challenge that some people have phones that do not work with the app, but I reassure noble Lords that it works with Apple iOS 13.5, Marshmallow 6.0 and the Huawei OS 8 or anything above.
My noble friend Lord Robathan challenged me about the evidence base for the curfew at 10 pm. My noble friend Lady Noakes quite rightly cited the SAGE notes that make the clear point that I made here yesterday when discussing masks: it is very difficult to put together the precise clinical trials and detailed modelling for individual measures that are brought to bear on the epidemic. But my noble friend Lady Noakes misrepresented SAGE when she implied that there was no evidence for the restrictions overall. The huge growth in the epidemic in recent weeks demonstrates the urgent need for these restrictions. The impact of the epidemic is not just on those who have Covid; it is also on those who find that the hospital beds they need are filled and on those who are put off going to hospital and therefore incur either delays or an impact on their current illness. There is also an impact on those who suffer as a result of any kind of avoidance of medical practice. The impact of Covid is not just on those who get it; it is on all those who seek medical attention. That is why, with the disease growing exponentially, we have to lean into it extremely heavily.
The noble Lord, Lord Birt, asked about the mass media campaign. I reassure him that we have invested massively and applied the best behavioural science to convey the restrictions as clearly as we can, and that that is backed up with quite severe sanctions, fines and police action.
The noble Baroness, Lady Watkins, raised, quite rightly, the challenge of getting visitors to social care settings, many of whom perform really important care duties for those in social care. We are completely live to the challenge of getting a regime of testing for those very important visitors. There are challenges in identifying exactly which visitors should qualify for such a scheme. We are building up our testing capacity to have enough tests available to them, and I shall be glad to update the noble Baroness when we have made progress.
My noble friend Lord Moynihan mentioned gyms. I completely endorse his commitment to fitness regimes, whether inside or on a beach. But it is true that local authorities in Liverpool suggested that closing the gyms would be a helpful way of restricting the epidemic.
We have been asked about balance. The Government’s strategy is one of balance. It is to contain the virus in any way we can while protecting the NHS, our economy and our schools. We are working extremely hard on the vaccine, on therapeutic drugs and on mass testing, which we believe will provide a route out of this horrible disease.
Health Protection (Coronavirus, Local COVID-19 Alert Level) (High) (England) Regulations 2020
Lord Bethell Excerpts(3 years, 11 months ago)
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Lord Bethell
That the Regulations laid before the House on 12 October 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, we are here to debate the middle, or “high”, tier of the new three-level system of local restrictions that we believe will be simpler for the public to understand, and therefore adherence will be higher.
Before I move on to that, I take a moment to pay tribute to my noble friend Lord Moylan, whom many of us know already. I really should have given the kind of testimony that a fantastic maiden speech in the earlier debate deserves. He did a very rare and precious thing: in just two minutes he established his credentials as “Mr Infrastructure” or, should I say, “Lord Infrastructure”. He got across the sense of wisdom, expertise and his phenomenal network, which he will undoubtedly bring to bear in the House and will be hugely valued for it. We give him enormous thanks for his pithy and effective speech.
This pandemic is the most important public health emergency that we have faced in a generation. We knew that our response would require a phenomenal national effort, but that we would also need to work closely with local authorities to control the transmission and spread of the virus. For their ongoing and substantial contributions to these regulations, I would like to thank local council leaders and other participants who have engaged intensively and constructively with the Government.
I have already outlined the strategy for the local Covid alert levels approach in the debate earlier this afternoon. The important objective is to enable easy-to-understand consistency in the application of restrictions across the country, rather than the localised variations which may have created confusion in the minds of some of the public. This should also allow the public to plan and prepare for stricter measures and understand the consequences of non-adherence.
This is necessary because the numbers tell a worrying story. The doubling time for the UK is currently between eight and 16 days, although this differs considerably across regions. As set out in the minutes from the SAGE meeting on 24 September, positivity is increasing, which similarly indicates that incidence is likely to be increasing, even when operational constraints mean that the number of confirmed cases may not be increasing quite as quickly.
The second wave is starting in the home. Recent statistics indicate that a total of 65,829 new Covid-19 cases were identified in the week to 6 October. Of these cases, 51,661—or 78.5%—occurred in private residential settings. The statistics demonstrate that once the virus is in a household, there is a strong chance that others in the household will catch the disease. There is very little we can do about this. The restrictions we are debating today primarily aim to reduce or stop the virus getting into the household in the first place. They reduce household-to-household transmission by seeking to prevent any indoor meeting of two or more households, which we know to be a key source of transmission.
The differences between local alert level medium, which we will debate next, and local alert level high, are focused on the need for reductions in the number and frequency of social contacts. At local Covid alert level high, people will no longer be allowed to meet with anyone from outside their household in an indoor setting; nor will support or childcare bubbles be permitted to meet indoors, except where exemptions apply. This measure includes private homes and Covid-secure hospitality, leisure and retail venues.
The rule of six will apply in all settings outdoors, including private gardens, pub gardens and recreational parklands. Everyone within the affected areas can continue to travel to venues and amenities that are open, for work or education, but they should look to reduce the number of journeys if possible. People are advised to walk or cycle whenever possible, or to plan their journeys to avoid busy times and routes if using public transport.
Additional support will be made available to local authorities to enable access to national systems in order to establish effective local tracing teams. A dedicated team of national tracers will be ring-fenced for their local area.
We want to see local enforcement teams using the full weight of the new rules and regulations. Environmental health officers and trading standards officers should be using their powers to ensure that businesses that are breaking the rules feel the full force of the law, working with the police when necessary. But more generally, enforcement of the rules will continue just as it does now, so businesses should ensure that they are complying with the rules. It is for them to ask their customers to do so in the first instance, and they can ask people to leave. But of course, as now, they can also escalate to the police if necessary.
Areas subject to local Covid alert level high are to be reviewed every 14 days to consider whether they are still at the correct alert level. In addition, the relevant regulations will be reviewed every 28 days, and will expire automatically after six months. In reviewing alert levels, the Government will make proper consideration of the best available data and the details pertaining to the local situation, including the incidence and test positivity, as well as the growth rate in infections, hospitalisation rates, the effectiveness of local measures, the weather, and other factors.
Fundamentally, this change is about putting in place the right balance of measures to reduce the spread of the virus. As the Prime Minister made clear in Monday’s press conference, our strategy is clear: to save life and protect the NHS while keeping in mind other priorities, including keeping our children in school and protecting people’s jobs and livelihoods. We are taking a balanced approach to tackling the virus where it is most prevalent by working closely with local leaders to take stronger action in order to save lives.
I take this opportunity to reassure the House that every day, week in, week out, we are in constant dialogue with local areas to make sure that there is local support on the ground for any extra measures and that the local perspective is combined with the wealth of data we now have, and share, on the spread of the disease.
The people of this country have been asked to make significant sacrifices in the Government’s efforts to combat this virus and its effects. The additional protections afforded by these changes deserve the support of this Chamber. I look forward to hearing your Lordships’ contributions in the course of this debate, and I hope that I will be able to respond to any concerns raised. I beg to move.
Lord Bethell (Con)
My Lords, the noble Baroness, Lady Thornton, is correct that it is a shame that we do not have time to go through each and every one of the local situations that have been brought up in the Chamber today. I would love to sit down with the noble Lord, Lord Scriven, to talk about Chesterfield, the noble Lord, Lord Greaves, about Pendle, and the noble Lord, Lord Beith, about Berwick. Each of them has articulated incredibly thoughtfully the complex and challenging local situations, where the interest of one community is at odds with that of another community, where dialogue between a small council and a higher council is at odds and where dialogue with the national authorities is challenging and difficult.
I will step back, if I may, because I cannot possibly comment on all the examples cited. If the Chamber will forgive me, I will take an optimistic view of all this. What coronavirus is doing is forcing all of us to work together to beat the epidemic. In my experience as a last-minute Minister on the front line of the battle against coronavirus, this is what I have seen time and again. I hope that noble Lords will forgive my sentimentality in this but, whether it is in the triple helix of the NHS, the business community and universities working together on test and trace, whether it is the partnerships I have seen between hospitals and social care working for the best interests of those in care, or whether it is the scientists working with the pharmaceutical industry to develop new therapeutics, I have seen amazing progress made in the spirit of collaboration. I have seen barriers broken down and relationships that should have been there getting stronger. The pain that we see and the anger that we hear on the television and radio in the blame game that is going on are, for me, the sound of people learning to live with each other, collaborate and beat it all together.
I feel the frustration of the noble Lord, Lord Hunt, but I am confused by his challenge because, on the one hand, he wants rapid action but, on the other, he wants agreement and engagement; I am afraid to say that those two things do not always sit together. I hear the pain of the noble Lord, Lord Beith, in Berwick, but I have to inform him that the decision to combine Northumberland and the north-east was taken very much with the participation of all the authorities, because they recognised that, with 200 per 100,000, they all needed to work together on the epidemic.
I pay tribute to the noble and gallant Lord, Lord Craig, who raised the challenge for all of us of the spirit of partnership and the sounds of Britons getting to know each other. I very much hope that we can get a benefit out of Covid, which will be that our levels of government get to know each other a lot better and work out how to collaborate in the fight against Covid.
A number of Peers mentioned the economy and the hospitality sector. I completely and utterly endorse the deep-seated and genuine concerns of those, including my noble friends Lady Warsi and Lord Lilley, about the economy generally and in particular the hospitality sector, which has been most graphically and acutely hit by the kind of restrictions we are talking about today.
I am enormously grateful to my noble friend Lady Noakes for describing me as a “puritan”; after spending a lot of my life on the wrong side of the curfew, it is a very redeeming moment for me personally. But my experiences in the night-time sector give me, I think, authority to speak on this subject, and I must share with my noble friend the insight that, after 10 pm, when young people mix with alcohol, I am afraid that intimacy and contagion are absolutely more likely. I am afraid to say that it is that insight that it is helping to inform our decision on the lockdown.
Meanwhile, we have done absolutely everything we can, in answer to my noble friend Lord Lilley, to help the hospitality sector with business grants, the Job Support Scheme, the sophisticated QR code contact-tracing system and trying to keep open the hospitality sector wherever we can, including by putting in special provisions for weddings. We will continue to work with the industry to do what we can.
On universities, I reassure the noble Baroness, Lady Walmsley, that the postcode challenge that she described is not one that is a material flaw in the plan. When they book their tests, students put the postcode of where they are living into the system, not their GP’s postcode—and we use more insight than simply postcodes to make our decisions.
I say to my noble friend Lord Lilley that the frustrating thing about this wretched virus is that it can sit in your body for 14 days without making itself apparent to any form of test—either PCR, lateral flow or Covid dog. That is why the instant test that you might get at somewhere like an airport can be only 7% predictive of whether you will have the disease at some time in the following 13 days.
I say to my noble friend Lord Lucas, “What excellent insight—absolutely top of the class in terms of epidemiological perceptiveness”. Cluster-busting is very much at the top of our list; we are deploying the latest artificial intelligence and genomics to try to do the backward testing that he described. Perhaps I may share this insight: instead of thinking of “superspreaders” as people, we are thinking more in terms of “super- spreading events”—such as the Rose Garden event—where, somehow, the way in which people are configured encourages contagion. And we are absolutely looking at low-sensitivity testing devices, as he described.
By way of conclusion, I pay tribute to the insight of the noble Baroness, Lady Thornton. Exit strategy is absolutely key. We are here debating the setting-up of these regulations; they are important regulations, and we are going into a second wave, as the deputy chief medical officer made crystal clear in his briefing to Peers yesterday. But an exit strategy is critically important. The kind of partnership that the noble Baroness, Lady Thornton, referred to and that I described at the beginning will be absolutely key to that. Local government and national government working together at all tiers will be the way in which we can establish the behaviours that are necessary to keep a lid on this contagion. That is very much the priority at the next stage of our thinking.
Health Protection (Coronavirus, Local COVID-19 Alert Level) (Medium) (England) Regulations 2020
Lord Bethell Excerpts(3 years, 11 months ago)
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Lord Bethell
That the Regulations laid before the House on 12 October 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, it is a disappointing fact that the rate of Covid-19 infections is rising rapidly across the UK. The ONS estimates that one in every 240 people in England had the virus between 25 September and 1 October and that the number of those who are infected is doubling every seven to 12 days. The scientific advice is clear that the disease is currently growing exponentially. To combat this, the new local Covid alert level framework standardises many of the restrictions that will be in place, making it easier for people to understand them and comply with them. As I have said throughout these debates, the new approach will be simple and constructive. I take this opportunity to thank local leaders who have engaged with the Government over the weeks and months as we have developed this system.
The Government will continue to work with local leaders to decide changes to alert levels. Decisions will be made based on a number of factors, including the rate of transmission, how quickly it is changing and the effectiveness of current interventions. The regulations we are discussing implement the restrictions known as local Covid alert level “medium”. They reflect the current national measures and are the minimum level of restrictions in place across England.
The restrictions on gatherings seek to slow down transmission by reducing social contact. They include the rule of six. This gathering limit, which includes numerous exemptions, strikes a balance between reducing social contact, allowing socialising to continue and minimising negative social and economic impacts. Additionally, a limit of six provides a clear message to the public to emphasise social distance. The rule of six means that, unless an exemption applies, nobody can gather in a group of more than six individuals, indoors or outdoors, unless everyone is from the same household or the group is made up of two households that are part of the same support bubble, or the individual is part of a smaller group attending a larger gathering being held in a public outdoor space. The organiser of the gathering must also have carried out a risk assessment and must take all reasonable measures to limit the risk of transmission of the coronavirus.
As I have described, there are exemptions from the rule of six. For instance, we are concerned about mental health, which is why we have legislated for support bubbles to help those most at risk of becoming isolated. There are also exemptions for work or voluntary purposes, education and training, formal childcare and providing care to vulnerable people, and there are exemptions for specific life events: weddings, civil partnerships, and funerals and commemorative events following a person’s death such as wakes, which are subject to a 15-person limit. As I explained earlier, allowing higher limits for these events balances the need of people to recognise significant life events while still minimising the spread of the virus.
The restrictions include measures for business. In the first debate, I outlined much of the evidence from SAGE, PHE and other studies which demonstrate that hospitality venues pose a high transmission risk. Therefore, these regulations require the closure of hospitality and some leisure venues, including takeaways, from 10 o’clock in the evening to 5 o’clock the following morning, except for delivery or collection during that period, as long as the order is placed remotely—for example, online or by phone. This, again, is to reduce the likelihood of people not adhering to social distancing rules, as compliance is often affected by alcohol consumption. The regulations also mandate table service if alcohol is served on the premises. Customers are required to be seated when they order their food and drink, which is then served to them. The business should take all reasonable steps to ensure that customers remain seated to consume it. If no alcohol is served, customers can order at a counter, but the business should take all reasonable steps to ensure that the customer remains seated while consuming the food or drink on the premises.
On business closures, the regulations close down nightclubs, dance halls, discos and other venues which open at night, have a dance floor or provide music, whether live or recorded, for dancing. This is because such businesses and services pose a much higher transmission risk and cannot currently be opened safely. We continue to work with representatives from these industries and business sectors to develop options to facilitate a safe way for them to reopen. The Government recognise the importance of these industries and have committed to a world-leading £1.57 billion rescue package to help them weather the impact of the pandemic.
The regulations create offences punishable by fines and provide for the issuing of fixed penalty notices. For individuals, the first offence carries a £200 penalty, which is halved if paid within 14 days, and the fine doubles for every subsequent offence up to a maximum of £6,400. For businesses and services, the first offence is £1,000, followed by £2,000, £4,000 and then £10,000 for every offence committed thereafter.
I reiterate that the Government express their profound thanks to the vast majority of people who have made huge sacrifices through this pandemic and will continue to do the right thing and follow the rules. However, to protect public health it is important that police have appropriate powers to deal with those who break the rules.
I once again express my thanks to noble Lords for their valuable contributions to this debate and the two earlier debates and for challenging us to do better in this vital area of public policy. I believe that we have met the bar set for us in these debates and that these regulations are proportionate and necessary to protect the public from the spread of coronavirus and to prevent a second national lockdown. I beg to move.
Baroness Thornton (Lab)
I thank the Minister for his explanation of this SI and indeed of the others. I compliment him, as other noble Lords have been doing, on—I do not know what the word is; “sturdiness” is not quite right—his resilience under fire, apart from anything else.
In many ways, this might be the most important SI before us today because it concerns the whole of the rest of the country, which is subject to restrictions that we are all very familiar with and know about. The success of combating the virus will depend in part on those restrictions being adhered to by the rest of the country, so that communities do not move into the next tier. As the Minister said, coronavirus cases are increasing at a terrifying rate.
I want to ask particularly about London. While it seemed that lockdowns were happening mostly in the north, it now seems that London might be heading towards one. Indeed the mayor, Sadiq Khan, has been pressing the Government to put in tougher restrictions in the capital for some time, such as a ban on households mixing. I echo what other noble Lords, including my noble friend Lady Andrews, have said: why are the Government hesitating?
All London’s 32 boroughs have been placed on the Government’s official watch list, which highlights that they are areas of concern, but some are more concerning than others. Eight London boroughs are above the infection rate threshold of 100 per 100,000. Ealing is 136.9; Richmond is 133.3; Redbridge is 124.5. Some of those rates are higher than those for boroughs and cities that are already included in the second tier. This is an important issue because London has very diverse communities and some very poor ones. One of London’s great strengths and, in these days of Covid, vulnerabilities, is how mixed it is and how large its BAME communities are. We have already lost too many BAME fellow citizens, particularly those who work for the NHS. London has not been spared any of that.
Compared to London, Doncaster has an infection rate of 136.9 per 100,000 and is currently in the high tier. Leicester went into lockdown on 30 June with an infection rate of 135 per 100,000. My honourable friend Jonathan Ashworth has asked why the city of Leicester is in tier 2 with restrictions, yet Charnwood—the constituency of Edward Argar MP—where the infection rate is 150 per 100,00, is not. Why are North East Derbyshire, where the rate is 164, or Barrow, where it is 277, not in that tier? There are questions about why other areas have not been included.
Sadiq Khan says that across our city
“the average over the last 7 days is about 90 per 100,000. All the indicators that I have: hospital admissions, ICU occupancy, the numbers of older people with cases, the prevalence of the disease, the positivity, are all going in the wrong direction. Which means, I’m afraid it’s inevitable over the course of the next few days London will have passed a trigger point”.
Is that correct? When was the Mayor of London invited to a COBRA meeting? Have conversations happened at a senior level with the leading citizen of our capital city, as they should have?
As my noble friend Lady Donaghy said in her pertinent questions, we are very concerned about probity. At some point, there has to be a reckoning of the governance of the contracts that the Government have given during this pandemic. My noble friend Lord Robertson underlined that point, in relation to track and trace. My noble friend Lord Rooker also raised the issue, with his usual tenacity. My noble friend Lady Andrews asked the Minister the key question which has been asked all afternoon. I am not sure that I have heard an answer yet. Why did the Government ignore the advice they were given on 21 September?
On a lighter note, the Minister referred to “the rose garden”. My noble friend Lady Donaghy asks whether he means the rose garden at the White House in Washington or the one that Dominic Cummings occupied in Downing Street?
Lord Bethell (Con)
I thank noble Lords for a detailed and illuminating debate which focused, quite rightly, on the interplay between the local picture and the national one. If these restrictions are about one thing, they are about trying to make focused, local lockdown work, so that we can avoid another great, clunking, national lockdown, which would come at enormous social and economic cost. We have seen some incredibly impactful local lockdowns work in Swindon—it was an intervention there, rather than a lockdown—Luton, Leicester and other cities. We are determined to try to make these work.
Getting them to work, as the noble Baroness, Lady Donaghy, rightly said, totally depends on getting the interplay between national and local government right. I am grateful to her for reminding us that the LGA has welcomed these restrictions and the spirit of partnership between local and national government.
In response to the noble Baroness, Lady Donaghy, yes, we absolutely want to work with and deploy the expertise of local authorities. We also absolutely need to back major restrictions with the money to support those communities—the charities and civic institutions, the businesses that are hard hit and the individuals whose jobs are put at risk or who need to stand down. I reiterate the sentiments of the noble Lord, Lord Dholakia, who said we will end up more united than we have ever been. I would really like to dwell on that positive sentiment.
To reassure the noble Lord, Lord Rooker, environmental health officers have been part of our thinking from the very beginning, and reminding us of that has been central to these debates. We spoke about this in some detail in the debate on the “very high” restrictions so I will not repeat myself, but we have put in a huge quantity of resources. We now have 1,000 tier 1 central tracers and 90 contract tracing partnerships, and we have doubled the number of local protection teams. In answer to the noble Baroness, Lady Jolly, local partnerships are absolutely central to our response to Covid.
In response to the noble Baronesses, Lady Thornton and Lady Andrews, the situation in London is very much on our mind. We are in daily, if not more frequent, contact with Sadiq Khan, who has made his sentiments very clear. The encouraging thing is that with these restrictions, and the other investments we have made over the last months, we very much have a shared platform of data on which we can make joint decisions informed by the latest information—information which in no way existed in February, March and April. Talk of data in those days was wishful thinking rather than practical. With these restrictions we have a structure for applying local lockdowns, and we have a much stronger spirit of partnership between national and local government.
The noble Baroness, Lady Andrews, talked about exit strategies, which is a critical question. We have local Covid plans in place in every local authority, and these plans govern the response of the local authority and create a template for the response to the epidemic. These restrictions give a new poignancy to those plans and a new importance to the exit component. Only by working collaboratively with the communities in those local areas will the kind of behavioural changes and containment strategies that can lead to exit really work.
The noble Lord, Lord Robertson, asked about Scottish interoperability. I completely share his frustration, but it is an aspect of the mobile phone app phenomenon that they tend to interfere with each other. We are working with the Irish, Welsh and Scottish DAs to bring about the kind of interoperable nirvana of which he dreams. We hope to introduce a new version shortly.
I would be very glad to write to the noble Baroness, Lady Uddin, with the protocols for those caring for the vulnerable. Those protocols exist and I would be glad to share with her a link to them.
To answer the noble Lord, Lord Rooker, youth clubs are open. There are extremely detailed guidelines for making them Covid-safe; that is the only way in which young people can mix together in those youth clubs. Again, I would be very glad to share those guidelines with him if that would be helpful.
Towards the noble Lord, Lord Bilimoria, I feel a degree of resentment. I thought that I was the country’s leading evangelist and advocate for mass testing, the power of surveillance and innovative technologies such as LAMP and lateral flows, but it seems that the noble Lord has stolen my crown, because he is absolutely the No. 1 evangelist for them. I applaud wholeheartedly his sentiments on that matter.
I am genuinely touched by the kind comments that people have made about these debates and my contributions to them. They are really important; there is a huge amount of them—nor do I think they will stop any time soon. I am glad that this debate is happening on the day that these SIs have been brought into force, which brings a new relevancy to it. I extend my thanks to my opposite numbers: to the rota of spokespeople on the Lib Dem Bench and to the noble Baroness, Lady Thornton, for her enormous stamina. She has been in lock-step with me all the way, and I am grateful to her both for her insightfulness and for the collaborative way in which she has gone about these debates. I extend my thanks also to the Whip, my noble friend Lady Penn, who has been a huge support and demonstrated massive stamina.
My noble friend Lord Eccles asked about the relevancy of these debates. They are absolutely relevant. There are instances where what has been said in this Chamber has been carried into the decision-making and discussions of policy as it has happened. On masks and face coverings, on the importance of sharing data with local authorities, on issues around shielding and communications to the vulnerable, on the role of local infection control and the directors of public health, on the entire areas of social care and mental health and on the impact of restrictions on the economy, noble Lords have expressed clear, insightful and well-informed views and wisdom, and those views have been shared in the decision-making process. It has been a demonstration of this Chamber at its very best.
Covid-19: Great Barrington Declaration
Lord Bethell Excerpts(3 years, 11 months ago)
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Lord Robathan
To ask Her Majesty’s Government what assessment they have made of the Great Barrington Declaration on the (1) physical, and (2) mental, health impacts of COVID-19 policies.
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, the analysis of the Department of Health and Social Care, the Office for National Statistics and the Government Actuary is clear. Mitigations have prevented more than 500,000 deaths and the associated heartache. As the Prime Minister made clear yesterday, it is right to look at alternatives, and I am grateful to the noble Lord for his Question. However, having looked at the Great Barrington declaration, we have decided that the idea of a great prevention is bad science and bad economics, and it is impractical. It would be an indefensible moral decision for any Government to take.
Lord Robathan (Con)
My Lords, the scientists from Oxford, Stanford and Harvard who are behind this declaration should surely be listened to as much as, for instance, the discredited Professor Ferguson or indeed SAGE. We know that NHS waiting lists are at an all-time high and that 3 million cancer screenings have been missed. We know that the average age of those dying from Covid is 82.4 years—higher than from other causes—and that a total of 313 people under the age of 60 and without comorbidities have died in English hospitals from Covid. Current policies are not working. Will the Government stop digging, get out of their hole and go back to first principles to determine the objective of their Covid policy, and then change tack to achieve that objective?
The Lord Speaker (Lord Fowler)
My Lords, I remind noble Lords to keep supplementary questions brief.
Lord Bethell (Con)
My Lords, I note that the 16,000 scientists supporting the Great Barrington declaration include “Dr Brian Blessed; doctor in winged flight, Z-cars and booming laughter”, “Dr Johnny Fartpants” and “Dr Johnny Bananas”. The serious point, however, is that the idea of “focused protection” is both unethical and impractical. Even if it was not, growing evidence of the impact of long Covid on the fit and young is mounting every day. On herd immunity, we currently have 8% sero-positivity, but we would need 70% for herd immunity, and it is completely improper to ask the young of Britain to suffer the risk of long Covid in order to achieve that. Winter is coming, and cold temperatures and more inside activity will raise prevalence. The great protection is simply not a conscionable option.
Lord Addington (LD)
My Lords, will the Government please look at the Equality Act when they are considering something like this? Take the case of a young disabled person who is very vulnerable; would taking any action like this be a breach of that Act?
Lord Bethell (Con)
The noble Lord makes a very good point. Although I have not had legal advice on this, I feel sure that he is on the right track. The great protection would condemn anyone with asthma or a learning difficulty, in old age, or with any major disability or immune challenge to be locked up while society turns its back. That is not a decision that this Government are prepared to make.
Lord Trees (CB)
My Lords, an exit from the pandemic will be achieved only when an appropriate level of population immunity is achieved, either by natural infection or vaccination. Given that the Government’s strategy is to rely on vaccination to deliver population immunity, what estimates and advice are Her Majesty’s Government receiving about the realistic timeframe, from now, in which an efficacious vaccine will have been given to sufficient numbers of people to establish that population immunity?
Lord Bethell (Con)
The noble Lord is entirely right in his analysis. The briefings from the Vaccine Taskforce to the Prime Minister are encouraging. One of the striking things about the updates is not only the promising nature of the Oxford vaccine, which is progressing very well, but the substantial pipeline of a dozen or more other vaccines that are coming through. Six of those have already been contracted by the Vaccine Taskforce on four different vaccine platforms. I am afraid that I cannot provide a firm schedule as such things are not in the gift of Ministers, but I am informed that progress is substantial.
The Lord Speaker (Lord Fowler)
I call the noble Lord, Lord Faulkner, who I forgot to call before.
Lord Faulkner of Worcester (Lab) [V]
My Lords, is the Minister aware that this so-called declaration is principally the work of the American Institute for Economic Research, a libertarian think tank funded by the Koch foundation and best known for its denial of climate change? As the Minister said in an earlier answer, a large number of the signatories are completely bogus. Does he agree that we should have nothing to do with fake science, which provides cover for a cull of the elderly and the disabled under the guise of herd immunity and promotes an American far-right agenda?
Lord Bethell (Con)
My Lords, there is some shared interest with those who drafted the Great Barrington declaration. They quite rightly make observations about the impact of the pandemic on education, and we are providing £1 billion to support those whose education has been hit by Covid. They make observations about support for those who are shielding, and we have written a new letter to 2.2 million people who are undergoing shielding. However, the noble Lord is entirely right: this is Johnny Bananas science, and we will not support it.
Baroness Thornton (Lab)
My Lords, the Minister and I are in complete agreement about this. The scientific understanding of Covid-19 suggests that having had the virus does not guarantee immunity. In fact, cases of second infections are emerging around the world. Does the Minister agree that, until we have a vaccine, this proposal is both dangerous and uncertain, and begs the question of who decides who needs to lock themselves away, and for how long?
Lord Bethell (Con)
The noble Baroness is entirely right. Not only is the evidence of reinfection mounting—a source of huge disappointment, frankly, but something that we have to realistically face up to—but the evidence of long Covid is also mounting, with nearly one in 10 young people infected with Covid reporting some kind of ongoing illness, and many reporting extremely worrying neurological, cardiac or renal damage. This is not flu; this is not a complex cold; this is not a posh version of a duvet day. This is a very serious infection that leaves a long effect on those who are vulnerable, and even on the young and fit. We should be very wary of it.
Lord Greaves (LD)
My Lords, what we need is some stability. Yesterday, as picked up by the media overnight, Lancashire and the borough of Pendle—here I declare my interest—were put into tier 2, which was welcomed locally by people and businesses. We now hear of discussions that, by the end of the week, we might be downgraded to tier 3. This is neither stability nor understanding. What on earth is going on? Is it a shambles?
Lord Bethell (Con)
My Lords, I pay tribute to the council in Pendle which, as those in the Chamber know, has done an enormous amount to fight Covid infection and has been exemplary in its approach to containment. However, it is a sad truth that the infection is spreading, particularly among the young, and making its way through the generations. You have only to look at the hospitalisation rates today to see that we will have a serious problem as the lag is complete; in a few weeks’ time, those rates will go up. The Government are taking prompt action, which is tough and unpleasant for those involved. I deeply regret the possibility that Pendle may be hit by harder restrictions, but this is a reasonable approach and it is done to save lives.
Lord Mann (Non-Afl)
My Lords, will people be healthier this winter locked up on Zoom, playing computer games and watching Netflix, or out in the fresh air, on the rock, hills and footpaths of England in a socially distanced manner?
Lord Bethell (Con)
The noble Lord is entirely right to champion the role of fitness, exercise and fresh air, and this Government are doing an enormous amount to try to keep sports going during current arrangements. He is entirely right that for families, young people and those used to the outdoors, the prospect of being locked up presents a huge challenge. No one is under any illusion: the prospect of a long winter under restrictions is deeply challenging and unpleasant. However, I celebrate and totally endorse his advocacy of fresh air and exercise.
Lord Craig of Radley (CB) [V]
My Lords, comment on Barrington has been destructively dismissive, so at present it seems to have little chance of acceptance. However, should the new three-tier strategy falter, will an alternative other than national lockdown be adopted which does not decimate the economy? If NHS pressures were thereby increased, have enough personnel been identified to staff the Nightingale hospitals fully, and continue other NHS work, and will they be ready for action if required?
Lord Bethell (Con)
The noble Lord is entirely right: the impact on the economy of a full national lockdown has been learned already. We know what that looks like. It is a very tough decision and it is my hope and expectation that the British public and the health system will respond to the challenge they face and will step up. I would like to guide the noble and gallant Lord to the publication by the Government Actuary’s Department, the Office for National Statistics and the Department for Health and Social Care Direct and Indirect Impacts of COVID-19 on Excess Deaths and Morbidity. It spells out in very clear terms the economic and mortality effects of letting the disease rip. Those costs are simply unconscionable.
The Lord Speaker (Lord Fowler)
My Lords, the time has elapsed for this Question.
Health Protection (Coronavirus, Restrictions) (North East of England) Regulations 2020
Lord Bethell Excerpts(3 years, 11 months ago)
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Lord Bethell
That the Regulations laid before the House on 17 September be approved.
Relevant document: 27th Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, we are all aware of the rising rate of infection, particular after this morning’s candid briefings, and the risks that it poses. Your Lordships will therefore understand the importance of taking the necessary steps to keep members of the public safe, while continuing to keep the economy running and schools open, and heading off the need for a second national lockdown.
We know that some of the rules put in place have become increasingly complex and difficult to enforce. That is why the Prime Minister has set out—or will set out—how we will further simplify and standardise local rules by introducing a three-tiered system of local Covid alert levels in England. This is not the subject of the debate today, nor does it change the legal requirement to wear face coverings, but it should reassure noble Lords that we continue to work with the local leaders to tackle outbreaks with more targeted restrictions that are simple and constructive.
The regulations being debated today introduced the requirement that members of the public should wear a face covering in taxis and private-hire vehicles. In addition, they should be worn when inside premises that provide hospitality, such as a bar, pub or restaurant, except when eating or drinking, for which people must be seated. This means that people must wear a face covering when entering, leaving and moving around the premises.
Baroness Thornton (Lab)
I think the Minister will find that we are supposed to be discussing the north-east, rather than the face coverings. It does not make any difference—I am quite happy to do them that way round, but we might get confused.
Lord Bethell (Con)
My Lords, I apologise and give great thanks to the noble Baroness for the polite and kind way in which she brought that to my attention. At this point, we are debating statutory instruments that apply to the north-east of England and were in force on 18 September. As your Lordships may know, a Prime Ministerial Statement in the other place will address these sorts of issues and we will of course keep a careful watch on the progress of that debate.
Over the past few months, local restrictions have allowed us to home in on areas where cases are high and rising, and put targeted measures in place. I understand that the measures we are debating have greatly affected families living in Northumberland, Newcastle, North Tyneside, South Tyneside, Gateshead, County Durham and Sunderland. Families in these areas are no longer able to meet relatives as they used to. I recognise the disruption the measures cause, particularly for those relying on often complex networks of grandparents and friends to help out with childcare. We must celebrate the complex civil communions which underpin so much of our day-to-day regimes.
However, this virus is transmitted by people meeting up with each other and the horrible truth is that the closer our friendships, the more relaxed we are in each other’s company and the harder it is to keep socially distanced. These measures are not taken lightly. They are driven by our public duty to protect the most vulnerable people in our society and do our utmost to ensure that this virus does not adversely affect these groups. What is of concern is that the number of cases in the over-60s is rising; we know that coronavirus symptoms can be more severe for people in this age group. I recognise that the Government are asking many people living in these regions of the north-east to make sacrifices to protect those most vulnerable to this virus. We will need to make adjustments to our daily lives until we have suppressed or eradicated this terrible disease.
Unfortunately, as cases have gone up in these areas, we need to introduce more of these local measures. On 18 September, we introduced new restrictions on household mixing, business opening hours and table-only service in pubs, restaurants and other places serving food or alcohol right across Durham, Gateshead, Newcastle, Northumberland, North Tyneside, South Tyneside and Sunderland. Unfortunately, again, despite these measures the number of cases continues to rise sharply. Incidence rates across these parts of the north-east area are now some of the highest in the country, with Newcastle’s rate now more than 534. So, at the request of the local councils, with which we have been working closely, we will introduce legal restrictions on families mixing with other families in their homes and being able to enjoy food or alcohol only if served at a table, and with non-essential businesses being required to close at 10 pm.
These are not steps that we take lightly but we must take them, and that is what we did because we know that swift action is more likely to bring the virus under control. The quicker we can do so, the quicker we can restore the freedoms we all enjoy—in the north-east and right across this country. Targeted measures were needed to tackle the outbreaks in those areas. The council leaderships collectively agreed that a ward-level approach would not be appropriate, as widespread community transmission had been observed in all areas. People move freely through the local authorities for work and leisure; for example, 40% of people who live in County Durham work in other areas.
These regulations prevent gatherings involving more than one household in private homes or gardens. There are exemptions for those in support bubbles, for example, and on compassionate grounds. We listened to feedback from the local leaders and amended these measures so that informal childcare support bubbles are allowed. Before the national restrictions for the same purpose, we tackled the risks of community transmission by allowing table service only in hospitality venues so that people cannot move about and pass on the virus. To reduce riskier behaviours often seen later at night when people have been drinking alcohol, we imposed the restriction on entertainment and leisure venues, limiting them to opening between 10 pm and 5 am.
Noble Lords will be aware that these regulations have since been amended so that they now also prohibit families meeting up with each other in any indoor space in these areas. We revised the guidance for owners and operators of indoor settings, including places of worship, to say that they should not intentionally facilitate indoor gatherings between households. We also advised that care homes should allow visits only in exceptional circumstances to protect their vulnerable residents. No restrictions have been placed on travel, but people have been advised not to travel with people from other households.
The Secretary of State is required to review the need for the restrictions at least every 14 days. The first review was completed on 1 October, and it concluded that the restrictions must stay in place. The next review is due this coming Thursday. I thank the seven local authorities for acting collectively as well as the local resilience forum, Public Health England, the joint biosecurity centre, local council leaders and the local directors of public health. I also thank the people in the protected area in north-east of England, who have responded so well to the measures put in place. It has been a tough year for many, and these regulations have a serious but necessary impact on how they live their lives. I beg to move.
Lord Bethell (Con)
My Lords, I am enormously grateful for the debate on these technical but very important SIs. I want to say a few words about lockdowns generally and the role of the national/local framework, and then answer the question of where we go from here.
The Prime Minister is on his feet in the other place at the moment, talking about local alert levels. I cannot pre-empt what he will say but I remind the Chamber that the Leader of the House will make a Statement here and provide a platform to discuss those important measures tomorrow.
I also remind the Chamber that local lockdowns are likely to play and remain an important part of our response to Covid. They are a way of avoiding national measures, in that they help to preserve the economy, keep children at school, protect the NHS and maintain a normal way of doing things. For that reason, getting local lockdowns right is enormously important. A debate such as this one is an important part of lending scrutiny to the process; I am enormously grateful for that.
I should also mention that the British public are enormously supportive of the principle of local lockdowns. Some 73% of Brits support local lockdowns in principle, while 68% would support them in their area if they were needed. In this sense, we are not cutting across the grain of public opinion.
I say in response to the noble Baroness, Lady Watkins, that there have been instances where local lockdowns have emphatically worked, such as in Bolton, Leicester and Luton. We learned there how prompt, accurate and emphatic lockdowns can really nip an infection in the bud. I also mention Swindon—as I did in the Chamber last week—where car sharing was identified as a source of transmission and nipped in the bud at a very early stage.
In response to noble Lords’ questions, let me say a few words about the principles that we apply to local lockdowns. On our approach, the noble Lord, Lord Hunt, asked about enforcement. Our guiding principle is to use consent wherever possible, but enforcement is necessary. Up to 21 September, 18,912 fixed penalty notices had been issued in England and Wales. It is shame that that number has crept up as high as it has done but that demonstrates the determination with which we are prepared to follow up on this important principle.
The noble Baroness, Lady Watkins, asked about the exit strategy. Let me reinforce the absolute primary importance of the exit strategy. She is entirely right: the public absolutely deserve to know how they can help to get their area out of lockdown. An important principle behind the Prime Minister’s announcement on local alert levels will be trying to design a way to articulate that so that there is a sense of common purpose.
On data, let me assure my noble friend Lady Altmann that incident rates are not the only thing that we look at; we also look at positivity rates so that we are not distracted by the increase in testing.
I assure the noble Baroness, Lady Thornton, and my noble friend Lady McIntosh that the mental health impact is a major concern. As an illustration of that, let me say to my noble friend that we are concerned about people who live alone. There is clear guidance on making a support bubble with another household. I would be happy to write to her with a link to that.
On technology, the noble Baroness, Lady Barker, asked about 111. Privately, I am incredibly pleased that she listened to what I have said on the matter. I assure her completely that there is massive investment in both people and the tech behind 111. It is incredibly important that that stands up well and provides people with the reassurance and advice that they need to make that a success.
Lastly, on the observation from the noble Baroness, Lady Barker, on households and pubs, the Joint Biosecurity Centre makes that kind of analysis. I agree that there seems to be evidence that household transmission is extremely acute. Once in a household, the disease often spreads to many people within the household, but of course it needs to get into the household in the first place. That happens in places such as pubs, clubs and hotels, although I am not sure that there is any evidence to distinguish between different venues and their transmission rates.
Local/national interaction has been the subject of a huge amount of comment. I completely hear and endorse a lot of the sentiments that have been heard. Our approach, despite what might appear from the debate, is very much a national/local partnership. We have come a very long way since February and March, when we initially discussed these matters. There are more local testing sites, local test processing sites, local tracing partnerships and local dashboards, and there is more publication of data. I would be very glad to provide a guide for any of that public data to anyone who would find that helpful.
The noble Lord, Lord Hain, is shocked to observe the outrage of local council chiefs over these measures. I am surprised myself. I reassure noble Lords that a huge amount of dialogue goes on every hour of every day at the moment between local authorities and central government, and that the narrative on TV is quite different from what happens in private conversations between all parties. There is very much a deep commitment by the Government to work in partnership. That is one reason why so much care, time and consideration has gone into the design and funding of the tiers being announced by the Prime Minister as we speak. Local support for these measures is absolutely fundamental to changing behaviour and to the public committing to the rules we apply. That is the principle set out in the Chamber and the principle that the Government understand. Because of that principle, we are taking the care that we are over the national/local partnership.
My noble friends Lady Morrissey and Lord Naseby, and the noble Baroness, Lady Wheatcroft, all alluded to whether we have a choice. That is a really important question. I completely share the exhaustion, frustration and occasional “What if?” feelings. There is no monopoly on knowledge in this Government; we do not necessarily get everything right. However, I invite my noble friend to read the publication by the Home Office, the ONS, the Government Actuary and the Department of Health on the direct and indirect impacts of Covid-19. It spells out in very clear, graphic and numerate detail what happens to a country such as Britain when it runs out of bed space, when there is an overwhelming demand for bed space that means that those with Covid or seeking bed space for another reason simply cannot get the attention they need. It spells out in clear detail what the impact on mortality would be were that to happen.
That publication also spells out the challenge of trying to enclose those who are vulnerable—the millions who are elderly, those with learning difficulty, those with diabetes and those whose ethnic background puts them into a special category. Millions of people are in the “vulnerable” category. Locking them up is neither conscionable nor practicable. We have tried this. Every year people try to keep their relatives out of the flu season. It makes no impact at all because people want to be with the people they love, and they need the attention and support of the social care workers who support them. For those reasons, the idea of confining the vulnerable to some form of isolation is neither conscionable nor practical. It comes down to a mixture of a values judgment and an economic judgment. History teaches us that those countries that have the stamina to defeat the virus bounce back fastest. That is why we take the approach we do.
To conclude and look forward from here, I once again acknowledge noble Lords’ frustration about the manner of these statutory instruments coming to the House. All I can say in response is that it is a negotiation for the usual channels and the Joint Committee on Statutory Instruments to decide when these matters are programmed. I am very much committed to being here whenever it is decided by noble Lords that these SIs should be discussed. The Prime Minister’s recommendations on tiering should, I hope, bring a more predictable and easily scheduled progress to these SIs. I very much hope that that will work.
In the meantime, in response to the noble Baroness, Lady Thornton, the Manchester, Sunderland and Harrogate Nightingales have been put on standby. There are more patients in hospital with Covid today than they were before the restrictions came in in March. This is a sombre moment and I am extremely grateful to noble Lords for a rewarding and constructive debate.
Health Protection (Coronavirus, Restrictions) (North East of England) (Amendment) Regulations 2020
Lord Bethell Excerpts(3 years, 11 months ago)
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Lord Bethell
That the Regulations laid before the House on 18 September be approved.
Relevant document: 27th Report from the Secondary Legislation Scrutiny Committee
Health Protection (Coronavirus, Restrictions) (Protected Areas and Linked Childcare Households) (Amendment) Regulations 2020
Lord Bethell Excerpts(3 years, 11 months ago)
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Lord Bethell
That the Regulations laid before the House on 22 September be approved.
Relevant document: 28th Report from the Secondary Legislation Scrutiny Committee
Health Protection (Coronavirus, Wearing of Face Coverings in a Relevant Place and on Public Transport) (England) (Amendment) (No. 2) Regulations 2020
Lord Bethell Excerpts(3 years, 11 months ago)
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Lord Bethell
That the Regulations laid before the House on 22 September be approved.
Relevant document: 28th Report from the Secondary Legislation Scrutiny Committee
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, we are all aware of the rising rate of infection, particularly after this morning’s candid briefings, and the risks this poses. Therefore, noble Lords will understand the importance of taking the necessary steps to keep members of the public safe, while continuing to keep the economy running, the schools open and heading off the need for a second lockdown.
We know that some of the rules put in place have become increasingly complex and difficult to enforce. That is why the Prime Minister has set out today how we will further simplify and standardise local rules by introducing a three-tier system of local Covid alert levels in England. This is not the subject of the debate today, nor does it change the legal requirement to wear a face covering, but it should reassure noble Lords that we continue to work with local leaders to tackle outbreaks with more targeted restrictions that are simple and constructive.
The regulations being debated today introduce the requirement that members of the public should wear a face covering in taxis and private hire vehicles. In addition, they should also be worn when inside a premises that provides hospitality—such as a bar, pub or restaurant—except when eating or drinking, for which they must be seated. This means that people must wear a face covering when entering, leaving and moving around inside these premises. Additionally, staff working in certain retail and hospitality settings should wear a face covering if they are in areas that are open to members of the public and are therefore likely to come into contact with members of the public.
I will now set out why this is a necessary measure, and how we have seen public behaviour change since the introduction of the first set of face covering regulations. A review of recent clinical research published in the Lancet in August suggested that face covering usage
“in community settings with reduced physical distancing might be justified.”
But despite this, the paper concluded that for Covid-19 this evidence is of
“low or very low certainty”
due to the nature of the data collection.
Studies published in the journal Nature have shown different degrees of support for face coverings. In an article at the end of September, the publication concluded that the effectiveness of cloth face coverings is not as well established as that for PPE in a clinical setting. This article recognised that face coverings are intended to protect the public from exhaled virus-containing particles, but points out that
“few studies have examined particle emission by mask-wearers into the surrounding air.”
In a news feature a fortnight later, Nature quoted studies suggesting that face coverings might have the capacity to save lives, but the article outlined the difficulty of establishing definitive proof. The BMJ pointed out on 7 September:
“There are large gaps in our knowledge and without clear evidence on the use of cloth masks in the community we may be wearing false reassurance.”
PHE conducted a rapid review in June of 28 studies into face coverings for community usage. At the time it concluded:
“There is weak evidence”
in these studies
“that mask wearing in the community may contribute to reducing the spread of COVID-19”.
There is, however, stronger evidence that the
“beneficial effects of wearing masks may be increased when combined with other non-pharmaceutical interventions, such as hand washing and social distancing.”
SAGE has advised that using cloth masks as a precautionary measure could be at least partially effective in enclosed spaces where social distancing is not always possible.
This is the scientific context for these measures. The Government have mandated the use of face coverings in places where social distancing is difficult and where there is closely shared space. We are not increasing high levels of acceptance that face coverings are gaining among the public. We need to be clear that face coverings are not a panacea; they are not a substitute for the key measures. Face coverings alone will not stop the chain of virus transmission, but to do so we must continue to maintain good hygiene, including when putting on and taking off face coverings, and follow social distancing guidelines and safe self-isolation advice.
As the WHO pointed out this summer, due to the limited evidence of the efficacy of homemade masks,
“their use should always be accompanied by frequent hand hygiene and physical distancing.”
With this in mind, noble Lords may have seen the recommendations published by the BMA this weekend about extending the use of face coverings in more settings, including outdoors.
We know that people are responding positively to these regulations, as it is reflected in data published by the ONS. On 11 May the Government advised the public to wear face coverings in enclosed spaces, and on 5 June ONS data suggested that only 32% of people reported that they had worn a face covering outside of the house. Fast forward to now, and ONS figures published on 9 October show that 98% of people had reported wearing a face covering when they leave the house. YouGov polls from the start of October provide further support for these findings. Data collected for the DHSC on health behaviours also show that since new regulations came into force on 24 September, 84% had worn a face covering in a restaurant, café or pub on some occasion, a rise of 22%.
This instrument is already benefiting members of the public and workers alike. I am enormously grateful to noble Lords for their continued engagement on this challenging process in the scrutiny of these regulations. We will, of course, reflect on this in the debate to come. I beg to move.
The Deputy Speaker (Lord Russell of Liverpool) (CB)
Just for the benefit of noble Lords, let me say that the noble Baroness, Lady Thornton, will not be speaking next; she will be winding up for the Opposition. The noble Lord, Lord Campbell-Savours, will be relieved that he is not winding up for the Opposition, and I call him next.
Lord Bethell (Con)
My Lords, I endorse the words of the noble Baroness, Lady Uddin, in thanking the Lord Speaker and noting his words on masks in the House. Who would have believed in February that a Lord Speaker would be sending an email recommending wearing masks in the corridors of the House of Lords? We have indeed come a very long way. I thank the noble Baroness, Lady Finlay, and the noble Lord, Lord Campbell-Savours, for their insight on the wearing of masks. They have both clearly taken deep dives into the scientific evidence, as I have, and have thought to synthesise from the raw data an understanding of how masks and face coverings may or may not protect the wearer and the society around them. The upshot is that it is not always crystal clear, as they both acknowledged, but there is interesting advice there for everyone.
The noble Baroness, Lady Jones, had in some ways the most interesting insight—at least to me. Out of the science comes a very human and important public health observation, which coronavirus has struck us all with: my health is important not only to me but to those who share my space and my health service. If I have coronavirus, it is not just of interest to me but to anyone standing near me. A communicable disease is just that. The clue is in the name. It is shareable with our neighbours. That is why the wearing of masks and face coverings is not only about protecting ourselves, but about protecting our community, our neighbour and our health system.
I take from this debate a real sense of optimism that public attitudes in the UK have massively changed. I note, in response to the noble Baroness, Lady Thornton, the huge endorsement of the wearing of masks: according to recent ONS figures, 98% of people say that they have worn a mask in the last few weeks. The scientific evidence on masks would endorse that spirit. A simple hand-made or cloth mask is a public service rather than a source of self-protection and it is all the more poignant and important for that reason.
We have come a long way since February and March when there was a serious and understandable concern about cannibalisation. As I said in the previous debate, we have tens of millions of items of PPE from hundreds of suppliers covering months of health needs ahead, so cannibalisation is no longer a fear. The example of south-east Asia is important. I note and echo those who observe the role of face coverings and masks in countries that have much to teach us about public health concerns. However, I reiterate some of the practicalities and concerns about inappropriate—and overreliance on—face mask wearing. It can be a displacement activity. For some people, it can be a way of channelling concerns and can lead to unnecessary risk-taking, particularly for those who are seeking to avoid social distancing. For some, it can be a distraction from the important regimens of hygiene. As I said in my opening words, it is absolutely imperative that those wearing masks are conscious of and abide by hygiene protocols—a badly treated face covering, reused over days, can become a vector for infection and a source of contagion.
These are the concerns of the CMO and why we have moved thoughtfully and not rushed into this. As the evidence base builds and public attitudes change, we are putting more and more store in this important area, particularly in those instances where social distancing is difficult and where masks can helpfully control or minimise contagion. There is also an important question of public trust. We do not want to be in a position where we highly recommend something that we cannot quite prove is effective. There are those who say, “Well if it doesn’t hurt, why not give it a go?” It can hurt, however, because if the public suspect that we are not relying on clear scientific evidence, that has an enormous impact on our trust figures.
The noble Baroness, Lady Finlay, mentioned the environment and asked about the measures we are taking to minimise the ecological impact. This is challenging. The best practice for masks is, frankly, to use them frequently. In south-east Asia, pupils bring three masks to school each day—one for the morning, once for lunchtime, one for the afternoon—and each one is thrown away after use. That is an enormous consumption of environmentally damaging disposable goods. I pay tribute to the Keep Britain Tidy campaign, which has done an enormous amount to try to think through the disposal of masks; work is being done to figure out ways of either reusing or recycling them.
I will answer some specific points. I absolutely, categorically and 100% reassure the noble Baroness, Lady Ritchie, that there is no herd immunity strategy. It is not the Government’s strategy and we have no plans to move in that direction. To the noble Earl, Lord Clancarty, I explain that masks are recommended for indoor areas in schools, particularly in places such as corridors where social distancing is impossible. It is up to headmasters to provide specific guidance but this is all explained in the guidelines. The noble Lords, Lord Greaves, and Lord Oates, and my noble friend Lady Wheatcroft spoke about shops. This is a challenging area but we are loath to put shopkeepers and shop workers in the firing line; it is not appropriate or fair to ask someone working behind a counter to police the wearing of masks. However, we are very serious about enforcement. In response to the noble Lord, Lord Oates, I pay tribute to Transport for London. Some 102,856 people were stopped between 4 July and 1 October. Of those, 1,753 were removed from public transport and 430 fixed penalty notices were issued.
The question from the noble Baroness, Lady Thornton, on Barking and Dagenham was very interesting. I do not know the full answer. I will seek it and write to her with whatever answer I can find. The noble Lord, Lord Greaves, asked where the transmission of disease comes from. He was right to say that there are different types of transmission in different categories. As we discussed in the earlier debate, households are where it all ends up. Household contagion is extremely high. Many households will originally be infected from the community, by their neighbours or in places where they socially congregate. The disease is introduced into communities from various distances. That is why we often look at ways of restricting transport, whether within a lockdown area or internationally. Finally, in answer to the noble Earl, Lord Clancarty, visors are not enough to cover mouths and noses; that is why they are not a substitute for a face covering.
Looking to the future, I have said enough on our desire to bring a more regular scrutiny to these kinds of statutory instruments; I completely endorse the words of the noble Baroness, Lady Thornton, on this. I remind noble Lords that it is up to the usual channels to schedule the business of the House. On the Joint Committee on Statutory Instruments corrections, I take note of the noble Baroness’s remarks. I have little to say in mitigation, other than to balance her well-meaning and frank remarks by paying testimony to the legal teams who do this work. I know that the noble Baroness would join me in thanking the legal teams who have the unenviable task of drafting these regulations, often late at night and at the weekend. I can tell noble Lords that this weekend was particularly tough for the legal team, who are doing their best under difficult circumstances. As I said, I pay tribute to their work. With that in mind, I beg to move.
Health Protection (Coronavirus, Wearing of Face Coverings in a Relevant Place and on Public Transport) (England) (Amendment) (No. 3) Regulations 2020
Lord Bethell Excerpts(3 years, 11 months ago)
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Lord Bethell
That the Regulations laid before the House on 23 September be approved.
Relevant document: 28th Report from the Secondary Legislation Scrutiny Committee.