Covid-19: Test Results

Lord Bethell Excerpts

Tuesday 27th October 2020 Lords Chamber

[Lord Scriven]

To ask Her Majesty’s Government what immediate changes they are making to improve the speed of test results for COVID-19.

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

My Lords, in the last two months we have responded to the rising demand for tests, the rising infection rates, the need to protect the front line in health and social care, the need for clinical trials for vaccine-to-medicines, outbreak control and surveillance by doubling the number of tests to 360,000. This has impacted turnaround times, which is regrettable, but we are focused on increasing capacity to raise efficiency, investing in the logistical backbone and encouraging users to the weekends, which will bring turnaround times down to the objective of next-day results.

[Lord Scriven (LD)]

My Lords, this morning I spoke to Allan Wilson, the president of the Institute of Biomedical Science, which represents 20,000 professional lab staff. He wrote to the department in early April to offer his free advice on how to improve the system and get a speedy testing system. Seven months later, the department responded with a letter advising him to go to the government portal for public contracts. Will the Minister now agree to meet the person who probably has the most experience of labs up and down the country? Why are the Government shunning Mr Wilson of the Institute of Biomedical Science in favour of paying £700,000 a day to management consultants?

[Lord Bethell (Con)]

My Lords, I am distressed to hear the anecdote that the noble Lord has just shared with us. We embrace the support and help of anyone who steps forward, particularly someone such as Mr Wilson, who clearly has an enormous amount of expertise. I would be delighted if he would write to me personally and I would be very prepared to meet him. I would also like give massive thanks to all those from all the relevant logistical, pathology, military and medical sciences who have formed an organisation practically the size of Tesco, which is what the national diagnostic system now looks like. It is only with the support of British industry, universities and business that we have been able to build this up and we are enormously grateful for that support.

[Lord Desai (Lab) [V]]

My Lords, we have had continuous failure of test and trace since March. Again and again, we are missing the targets. Why? Is it the equipment, the personnel or the management structure that is causing this failure of our efforts?

[Lord Bethell (Con)]

I am not sure that I can answer the false premise. Actually, test and trace has enormous achievements—the isolation of 1 million people who would potentially have spread the disease is the most glaringly obvious—but we are here to talk about turnaround times and there, I completely accept that the current performance is not where it should be. I have sought to explain the reasons for that, and the enormous increase in capacity in the last 60 days. I have also sought to explain the measures we are putting in place to mitigate that. I am confident that those measures will be successful, and I am happy to report back to the House on them

[Baroness Jolly (LD)]

My Lords, South West Water and Plymouth City Council have been co-operating in the testing of wastewater across the city to determine the strength and location of Covid outbreaks. What guidance has Public Health England given to local authorities on this, and what analysis has it done on this sort of testing?

[Lord Bethell (Con)]

The noble Baroness is right to cite the use of wastewater analysis. The innovations and partnerships team at test and trace has a programme to look at precisely that method. We are particularly interested in using targeted wastewater analysis at schools and in social care in order to promptly identify the presence of the disease. We are looking in particular at technologies that have already been trialled in Italy. The trials are extremely promising, but I would be happy to make that connection between South West Water and the relevant team so that their knowledge is usefully used.

[Lord Robathan (Con)]

My Lords, what study has been undertaken into the efficiency and accuracy of these tests; by which I mean how many false positives and false negatives there are? Furthermore, what is the long-term strategy regarding this? If, every time restrictions are relaxed, tests show that infections rise, are we then just to continue imposing lockdowns ad infinitum?

[Lord Bethell (Con)]

My Lords, we have a very intense and rigorous validation programme around the various tests. They look at sensitivity and false positives. We do not believe that the current machines we use have a high risk in that department, but we always keep a close look at it. I am extremely grateful to those businesses that have developed new and innovative tests that we are rolling out all the time.

[Baroness Masham of Ilton (CB) [V]]

My Lords, what does the Minister think about trained sniffer dogs to detect Covid-19? Does he know that the London School of Hygiene & Tropical Medicine is one of several groups that have assessed the accuracy of using sniffer dogs?

[Lord Bethell (Con)]

My Lords, I take my hat off to the London School of Hygiene & Tropical Medicine, which runs an extremely exciting trial. In fact, the Secretary of State is visiting this very afternoon in order to get an update on that trial. Dogs can be used as a way of screening crowds in such places as airports and high-density venues. The validation of that method has not been proven yet, but I am personally extremely hopeful and remain grateful to those involved in the pilot.

[Baroness Thornton (Lab)]

We move from dogs to the technical teething problems with the app. It seems that the NHS Test and Trace app sends out exposure warnings to people stating that they have to isolate and then a few hours later sends another alert saying that there is no issue and they do not have to isolate. That probably means it is working quite well, but it does not tell anybody where they might have been exposed, or, as I have experienced, it flashes at you that you have been near someone who has tested positive and then there is complete silence. When will we be able to trust the technology to help us as well as alarm us? Secondly, when will the care homes testing speed up? Care homes’ turnaround time for tests still seems to be stuck in three to five days on average.

[Lord Bethell (Con)]

My Lords, on the app, the noble Baroness alludes to two separate issues. The first is the exposure notices, which are not sent by the NHS app but by the Apple telephone device. We have put in the new version of the NHS app a way of mitigating those exposure notices. She is entirely right that the app has no idea of your geography; that is the genius of the app and its commitment to privacy. It means that we cannot tell you where you were exposed, but also that your location and privacy are protected. On social care, we are investing in a large number of trials to try to speed up mass social care testing, including bulk testing and the use of wastewater, which we discussed earlier.

[Baroness Sheehan (LD) [V]]

My Lords, on 25 September, NHS England gave guidance specifically to implement pool testing to speed up testing times. Since then, what increase in pool testing has taken place?

[Lord Bethell (Con)]

My Lords, pool testing offers a huge opportunity to cover a large amount of ground very quickly, and there are some workplace testing champions for it, including Amazon. However, it has some restrictions, in particular not knowing the identity of the person who might have tested positive. That is why we are running a large number of pilots at the moment and investing heavily in trying to figure out this exciting but challenging technology. We will deploy it the moment we can find a model that works.

[Baroness Jones of Moulsecoomb (GP) [V]]

My Lords, there have been a lot of allegations of corruption in the tendering processes for various aspects during the pandemic. I am curious whether the Minister feels that that could have some impact on the efficiency of what is happening now. When will the Government work with the right people?

[Lord Bethell (Con)]

I acknowledge the presence of fraud and condemn all those involved, but I do not see the connection between fraud and inefficiency.

[Lord Field of Birkenhead (CB)]

My Lords, I ask the Minister to convey our thanks to those rank and file workers who are trying to make this system work. I also say that, until he modifies the scheme so that we have local tracing, there will be many more sessions of Question Time that will be embarrassing for him.

[Lord Bethell (Con)]

I am extremely grateful to the noble Lord—I am never embarrassed—for giving me the opportunity to say a massive thanks to those tens of thousands involved. They take a huge amount of heat from the criticism targeted at test and trace, but many of them are working through the night to hit our targets, because people often take their tests during the morning or the afternoon. A lot of them work at the weekend and during holidays, when people often want their test results. It is arduous, tough, technical work and we are enormously grateful to those concerned. On local testing, we have in place 100 local test partnerships between local authorities and the national test and trace system which are proving extremely valuable, particularly in targeting hard-to-reach communities. We are putting an enormous amount of resources into them and they are proving extremely successful.

[The Lord Speaker (Lord Fowler)]

My Lords, the time allowed for this Question has elapsed. That brings Question Time to an end.

Medicines and Medical Devices Bill

Lord Bethell Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn from the debate, so I call the noble Baroness, Lady Jolly. Is Baroness Jolly with us? I am going to call her one more time; then we will have to move on, I am afraid. Baroness Jolly? Apparently not, so I now call the Minister.

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

My Lords, I give profound thanks for the debate on this group and start by reassuring the Committee that safety is very much at the heart of the Bill. Doing what is right for patients is at the heart of it but I acknowledge the remarks alluded to by my noble friends Lord Lansley and Lord O’Shaughnessy: patients are also entitled to have conversations with their doctors about what is right for them. That sometimes goes beyond a conversation about safety. To have those balanced, personal conversations to offer them hope, with innovative new treatments or in a clinical trial, we need other considerations to work together; we need the full picture and I want to make a few remarks on getting that balance right.

Before I do, I acknowledge the very touching and moving human stories that a number of noble Lords remarked on in this debate. I always find this subject extremely moving, and it is entirely right for us to remember the tough anecdotes and testimony of those groups which have advocated on behalf of the victims of terrible misadventure and clinical mistakes in the past. I also acknowledge what the noble Lord, Lord Alton, referred to as misogyny and what the noble Baroness, Lady Thornton, referred to as being ignored by the clinical profession. These two aspects of the situation weigh most heavily on my mind.

Before I move on to the testimony of the noble Baroness, Lady Cumberlege, I thank her for the hard work that she and her team put into her report. I reassure her and others that there is no question of the report in any way being buried or overlooked, or not cared about. The report, which was delivered in late July, is being weighed up with seriousness and intent. I reassure all those who are part of this debate that the Minister for Patient Safety, Nadine Dorries, is working up a response to it which will be delivered thoughtfully and with impact when the time is right. I completely and utterly recognise the support from across the House and from patient groups for the report’s recommendations and import.

However, patient safety is not the only aspect of the Bill, which we think needs to get the balance right between different aspects. Perhaps I may flag to noble Lords our amendment on this, Amendment 2, which inserts on page 1 at line 6:

“The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”


We think that Amendment 2, agreed last Monday, gets the proportionate and balanced approach correct and that we have practical regulation which can rise to the challenge of public health. I spoke last week to the reason for Amendment 2; it is a floor, not a ceiling. It means that the appropriate authority must be satisfied that regulatory changes promote public health, which is an important introduction to the Bill.

Whenever we reach this House, we deal with matters of nuance. We have discussed my noble friend’s amendments to change the way in which considerations apply, to one of an “objective”. With Amendments 8, 55 and 73 the noble Baroness, Lady Thornton, has proposed additional curbs. She has asked for regulations to be made that

“act with a view to ensuring”

that three considerations are met. I would expect to be asked under what circumstances regulations might be made that do not

“act with a view to ensuring”;

It would not be scrutiny by noble Lords if I did not. When we looked at this construction, it seemed likely that matters we might well wish to regulate on that were not specific to the considerations would fall out of scope. The burden of proof that those regulations met the bar the noble Baroness would set would be very high. “Ensuring” is the question here.

Government Amendment 2, which was passed last week, sets that threshold for regulation, where the authority must be satisfied that regulation would promote public health. I hoped that it would satisfy, but I am open to further conversation with the noble Baroness on this and, of course, other matters.

If the root of the issue is how the considerations will be applied by the appropriate authority, the noble Baroness will be aware that the Government have tabled amendments to Clause 41. Those amendments would change the way in which consultation is run. We would be obliged to include initial thinking on how the considerations have been applied to the development of regulatory change proposals so far.

The noble Lord, Lord Sharkey, has with Amendment 9 also suggested that an assessment of impact on these three considerations be published alongside draft regulations. He knows that an Explanatory Memorandum and an impact assessment must be produced when making a statutory instrument. While we are not there yet, I draw his attention to government Amendment 131, which would oblige the Secretary of State to report to Parliament every two years. That report must contain concerns raised during consultation, with that consultation informed by the Government’s initial assessment of the considerations. Parliament will therefore have the Government’s assessment but also the public’s assessment of the Government’s assessment. I hope that that is reassuring to the noble Lord.

I started this group by touching on the importance of patients and I am grateful to my noble friend Lady Cumberlege for her Amendment 10. She has support for it. I fully understand and support the rationale for wanting medicines and medical devices to be safe for patients. However, Amendment 10, placing the safety of medicines above all other considerations, could inadvertently put patients at risk.

The noble Lord, Lord O’Shaughnessy, alluded to availability, for example. During the pandemic, much has been done to ensure supplies of medicines—new experimental medicines, old medicines for different purposes or medicines that are at least available when others are in short supply. We have introduced a number of regulatory flexibilities, which have been widely welcomed by industry. They have helped to secure continued supply in a very challenging situation.

While patient safety underpins everything that the MHRA does, these changes were introduced for the primary purpose of ensuring continued supply. If we placed the safety of a medicine above all other considerations, we might put the safety and health of the patient and wider public at risk should they not receive the medicines that they need.

It would also potentially mean challenges in getting patients new medicines. A medicine that is novel or offers a great deal of hope might be inadvertently ruled out because of concerns regarding poor clinical practice or potential use in patients for whom it is not appropriate. We do not want to deny a potentially effective medicine to all patients in all circumstances. By placing safety as the primary consideration, clinical trials would also be almost impossible to conduct. By their very nature, they seek to test the safety of medicines.

I understand the noble Baroness’s concerns. She is deeply motivated by a desire to prevent what has happened before from happening again. I have spoken to patient groups. I am a father of daughters and a husband to a wife. I was deeply affected by the speeches made at Second Reading. However, I think that her objective—the safety of patients, not the safety specifically of medicines and medical devices—is protected by the government amendments that were passed last week. We will not be able to make regulations if we cannot be satisfied that they promote public health. That rules out deregulation for deregulation’s sake, for instance, but it allows, particularly in the case of an emergency, getting treatment to patients.

I hope that the noble Baroness will understand that we are aligned in intent, if not in delivery. We have designed that overarching test—that the appropriate authority is satisfied—to deliver on the safety of patients without preventing, for example, regulation in a pandemic. I know that she has spoken to my officials. I welcome ongoing conversations through the passage of the Bill, in Committee and beyond.

--- Later in debate ---

[Lord Hunt of Kings Heath (Lab)]

My Lords, I thank the Minister for his response. Could he say a little more about the Government’s overall patient safety strategy? He is saying essentially that the Bill is confined to medicines and medical devices regulation, yet underlying the concerns of the noble Baroness, Lady Cumberlege, is the fact that patient safety has not been gripped. In a sense, he has given a technical response. We will come to more specific amendments relating to, say, a patient safety commissioner, but at some point it would be interesting to get an insight into government thinking about patient safety more generally.

[Lord Bethell (Con)]

I will be candid with the noble Lord. The Cumberlege report has put patient safety absolutely at the top of the agenda. If it was not for Covid, it would be the primary issue of today in health matters and would lead all our thinking for the year ahead. The report is incredibly important and it has made its mark in a big way. However, it was delivered at the end of July and, if you take out August, that is only six or seven weeks ago. It takes a bit of time to respond to these reports. I know that the noble Baroness is chafing at the bit and wants a response—of course she does—but it has not been very long in report terms.

I cannot avoid the obvious, which is that we are in the middle of an epidemic. The Department of Health is completely overrun. We have nearly doubled in size in the past four weeks, but even so the capacity for response, in ministerial time and official time, simply is not there. I completely understand the keenness of noble Lords in this Room to get a clear response, but the sequencing is that this is a Bill on medicines and medical devices. We seek to take on board the lessons of the Cumberlege report and, where possible, specific items, but the Bill is not designed to be a vehicle for the implementation of the report recommendations. We will acknowledge and, where possible, accommodate the report’s insight, but the report needs a formal response from the Minister for Patient Safety and I am not that Minister and there has not been time for that response to arrive yet.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

My Lords, I will have one more go to get the noble Baroness, Lady Jolly, to join us. Lady Jolly? It is rather sad calling into the void. I take it that she is not able to join us, so I call the noble Baroness, Lady Thornton.

--- Later in debate ---

Moved by

[Lord Bethell]

14: Clause 1, page 1, line 11, leave out paragraph (c) and insert—
“(c) the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines.”Member’s explanatory statement
This amendment clarifies what was meant by the version of Clause 1(2)(c) in the Bill as brought from the House of Commons.

[Lord Bethell (Con)]

My Lords, in moving Amendment 14, I will also speak to Amendments 57 and 77 in my name. These all relate to clarification of the Government’s use of “attractiveness” in the Bill.

Our life sciences sector is critical to this country. It achieves great things. We have the RECOVERY trial. We have an industry that rose to the ventilator challenge issued earlier this year. It contributes to the economy and jobs; in turn, the Government have committed to ensuring that it continues to do so.

Our approach to regulation is a pivotal part of supporting that. I know that much was said at Second Reading as to how attractiveness might be defined. A number of amendments have been tabled to define it, all of which demonstrate the importance of this part of regulatory consideration. I look forward to hearing the debate on them.

To provide greater clarity on our meaning and intent of the “attractiveness” consideration in Clauses 1, 8 and 12, I have brought forward Amendments 14, 57 and 77. They set out that, as an integral part of the development of proposed regulatory changes, regard will be given to the favourability of the UK as a place to conduct critical medicine and device development, manufacturing and supply processes.

They also clarify our intent that Clauses 1(2)(c), 8(2)(c) and 12(2)(c) reflect that the Bill is a platform for us to continue to support increased investment in the UK to develop and supply medicines and devices, by ensuring that we make regulation that is sympathetic to that need. That is why the amendments strengthen the consideration regarding the likelihood of the relevant part of the UK to be seen as an attractive or favourable place in which to trial and supply human medicines or develop and supply veterinary medicines and medical devices.

I am pleased to see that this focus on favourability echoes language in amendments put forward by the noble Baroness, Lady Thornton, and the noble Lords, Lord Patel and Lord Hunt. Many of the proposed amendments on the definition of attractiveness provide an explicit list of specific elements that could underpin a consideration of favourability or attractiveness of the UK as a place to develop and supply medicines and devices, but I am confident that the current drafting already captures the multiple different stages that are inherent in seeing these goods placed on the market and supplied to patients.

The noble Baroness, Lady Thornton, and others have commented on the fact that this is a new term in legislation. Attractiveness means doing everything reasonable to be the first place where new treatments are identified, developed, rolled out and adopted, where investment in life sciences takes place and where the enrolment of patients in clinical trials is supported. It is neither necessary nor helpful to set out in the Bill all the different factors and stages of the development and supply landscape that will enhance the attractiveness and favourability of the UK. Providing a narrower definition limited to specific factors and elements of the current development and supply landscape risks excluding aspects of supply that are not yet in place. If we cannot currently predict the scale of innovation that these sectors may offer in future, can we accurately predict all the factors that will ensure that the UK is an attractive place to bring those innovations?

Government Amendments 14, 57 and 77 work together with government Amendments 2, 7, 51, 54, 56, 68 and 72. These place an obligation on the appropriate authority to be satisfied that the effect of the changes will be to promote the health and safety of the public or, in the context of veterinary medicines, that the regulations promote the health and welfare of animals, the health and safety of the public or the protection of the environment. It is part of that assessment into whether health and safety would be promoted that the appropriate authority must have regard to safety, availability and attractiveness.

In combination, I am firmly of the view that these amendments will ensure that appropriate rigour is given to how the key powers in Clauses 1, 8 and 12 are exercised. These amendments provide additional nuance. They clarify but they do not proscribe. They rule in rather than ruling out. I beg to move.

--- Later in debate ---

[Baroness Thornton (Lab)]

I thank all the speakers who supported our Amendment 20 and the amendments that follow on from it. I need to start by placing on the record that we do not agree with the Government’s amendments to this clause but we will not object to them. Were we not in the situation of basically having to agree to put these amendments in the Bill, this is a very good example of where we would need to have a different kind of debate. Looking specifically at the Government’s amendments, I think that adding the word “favourable” does not clarify the meaning or elucidate anything. Since we are not absolutely certain what “attractiveness” means, I am not sure we can be clear what “favourable” means either.

Our amendments, and others that noble Lords have tabled, would take the first stab at defining “attractiveness”. I am very attracted to the amendments that the noble Lord, Lord Sharkey, spoke to, because the idea of improvement is also very important. We are in the same territory and we will need to put further thought into this between now and the next stage of the Bill.

My noble friend Lord Hunt was completely correct when he spoke about the need to address how slow we are in this country in the uptake of new medicines and innovations. The noble Lord, Lord Patel, said that if we do not define “attractiveness” we might end up with the sort of undesirable trade-offs we discussed earlier today.

We have had a very interesting and useful discussion—the kind of discussion we should have in Grand Committee—where various points of view come together. We can see that we might end up with a completely new amendment at the next stage that will define “attractiveness” in the Bill and talk about the need for improvement and innovation. We will probably need to put our heads together between now and then.

[Lord Bethell (Con)]

My Lords, this has been an important discussion as to what attractiveness of the UK means. We have already moved on this issue with our amendments. We are still listening. I thank noble Lords for an instructive and wise discussion of this issue.

The noble Lord, Lord Sharkey, offers a definition in Amendment 15 that would include manufacturing. My noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, suggest adding “medical innovation”. In Amendment 20, the noble Baroness, Lady Thornton, and others set out a number of additional aspects, such as

“favourability to the establishment of research, design or manufacture of medicinal products or related services”

I reassure all those noble Lords that it is our instinct that the consideration of “attractiveness” as written in the Bill is sufficiently broad. It contains multitudes. While processes such as the clinical investigation of devices are not specifically listed as a consideration in Clause 12, they are covered in the current wording. Manufacturing is of course a vital element of the supply chain. Any impact on manufacturing will be relevant when considering the attractiveness of the UK as a place to supply medicines.

I acknowledge that the term “attractiveness”, as noble Lords have remarked in conversation, is not ordinarily found in legislation. However, I believe it is largely one of common sense. We all wish to protect the ways in which the UK is attractive. In 2015, the ABPI estimated the value of the life sciences sector to be £30.4 billion. Some 482,000 jobs were supported by the sector. We wish to protect that and to be a place for both innovators and generic manufacturers.

That is why this test is essential. It is a reminder, but it does not need to be comprehensive in the legislation. It needs simply to rule in, not rule out. That is why manufacturing is not explicitly mentioned, nor the other factors, although it is covered. Were we to list all the various aspects of how medicines and devices are made, we might miss something. We might interpret this list as prescriptive, rather than illustrative, and not cover an equally important but novel aspect of the future.

I hope that the government amendments provide further clarity. While noble Lords have drawn attention to specific aspects of how the UK is attractive, which are very important, their amendments are unnecessary. However, if there are particular considerations that the noble Lords, Lord Hunt and Lord Patel, and the noble Baroness, Lady Thornton, have concerns about—I note words such as “procurement”, “scale up”, “adoption”, “take-up of innovation” and “data-driven technologies”—I ask them to write to me. If further reassurances can be provided on why we consider this to be the right construction, I will be happy to respond.

In this instance, I hope the noble Lord, Lord Sharkey, is therefore willing not to move Amendment 15, and that other noble Lords do not feel compelled to move their amendments.

Amendment 14 agreed.

Covid-19: South Yorkshire

Lord Bethell Excerpts

Thursday 22nd October 2020 Lords Chamber

[Lord Scriven (LD)]

My Lords, I declare my interests as a resident of Sheffield and, knowing the area well, as a former leader of Sheffield City Council. I note that I will not be the only former leader of Sheffield City Council who will speak on this Statement; unusually, we will probably both agree with each other again.

We have to remind ourselves that going into any of these tiers, particularly very high, and a blanket lockdown is a failure of one thing: an effective test, trace and isolate system. Countries that have that do not have to have blanket lockdowns; it is absolutely vital that the Government understand that.

There is beginning to be a feeling of a north/south divide on this. It is ironic that Greater Manchester has not had any extra support for jobs when it has been in the equivalent of tier 2 for quite a few months. It is telling that, just a couple of days after London goes into tier 2, suddenly the Chancellor is on his feet talking about a tier 2 system for extra job support.

Having spoken to a number of people in South Yorkshire over the last 24 hours, let me tell you what the feeling is: anxiety, fear and uncertainty. I have spoken to people in tears, who have a business and who just do not understand why they are asked to do things. I reiterate the comments of the noble Baroness, Lady Thornton: you cannot plan a business or your life if you have no idea of the criteria and the trigger points for being released from tier 3. This cannot be left to a number of suits in an office, deciding the livelihoods and the businesses of many areas. What are the criteria and the trigger points for release and for going into a certain tier—not just tier 3? They need to be public, not the private judgments of people in a private meeting.

Also, why is the support package per head and not more nuanced? The support package for people in Sheffield is £29 per head—£30 million for business and £11 million for public health—but why is it a flat rate? When we know that older people, BAME communities and deprived people are more affected, why is there not a weighting in an area for those particular issues? They are the ones who will be greatly affected and more spending will be needed. Again, why is the business support package per capita? Why is it not based on the number and type of businesses that will be affected? Why does the formula seem so out of sync with what local areas will need to do?

I am pleased that there is support, at only £8 per head, for public health, which includes a local test, trace and isolate system. From this support, apart from money, what extra resources and expertise will local areas in South Yorkshire be able to call on to implement an effective localised test, trace and isolate system? We want to do our bit in South Yorkshire but we want to see fairness and a package that will minimise the effect of this high-level rate on both businesses and people.

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

My Lords, the noble Lord, Lord Scriven, put the sense of jeopardy and anxiety about the current situation extremely well. Anyone providing for their family or running a business will feel a huge amount of anxiety or even deep concern about the prospects for the next few months, and that is completely understandable. That is why we take all these matters incredibly seriously, why we are focused on it as a Government, and why we have made it such a large priority. The noble Baroness, Lady Thornton, put the grave sense of jeopardy extremely well when she referenced the Vallance graph, which was so derided when it was first posted and which has come to haunt us since then, the clear sense of concern from Jonathan Van-Tam, and the description of the state of our hospitals and intensive care units from Steve Powis. All those were grave warnings and have come to play out in a way that I am afraid worries us all.

At the heart of this debate is a question about the local lockdowns. They are necessary for those very reasons I just described. The infection rates have gone through the roof, they are profound, and they are having an impact right through all the demographics. In many cases they may have started in universities and with young people but they have moved relentlessly through the age demographics and are leading to hospitals filling up in a way that any mathematician, or anyone like me with an O-level in maths, can see is completely unsustainable without a major intervention. Our priority is to try to manage those interventions in a way that strikes the right balance, preserving the economy, keeping the schools open and keeping our lives as normal as possible, but which has an impact on the transmission of the disease. That is why these local lockdowns are so very important, because they are a way of introducing targeted measures to populations in a way that can close down the spread of the disease within a community.

When we say “community”, one of the lessons we have learned is that people travel within their regions a great deal, so we cannot be laser-like and targeted and just shut down a street, a town or a village. We have learned that we have to apply it to substantial regions; otherwise, the disease rolls from one small community to the next. Making these local lockdowns work is not in any particular government interest but in all of our interests. I ask noble Lords to step back from the temptation to introduce party politics into a subject which is driven by genuine public health concerns. It does not help anyone to talk in terms of north-south divides, people being at each other’s throats, scum, or any of the other political rhetoric that has been associated with the last week.

I come back to something that I have said many times at this Dispatch Box. It has been derided by those on the Benches opposite but it remains true and I see it every day of the week. There is a huge amount of bilateral and multilateral dialogue between central government and the agencies of central government—including the Cabinet Office, the DHSC, BEIS, MHCLG, NHS Test and Trace, and the NHS—and those in the regions and in the DAs. There are massive weekly calls, such as the one between the CMO and the DPHs, the one between the BEIS Secretary of State and the business community up and down the country, and the Thursday call between the MHCLG and 350 council chief executives and leaders. There is a relentless drumbeat of engagement and a huge amount of engagement on a one-to-one basis, as was shown by the revealing telephone logs of those on the phone to the mayor of Manchester on Wednesday, which seems to suggest that he was much more in touch with central government than perhaps was apparent from his photo call. I reassure the Chamber that that spirit of partnership to get the local national partnership working is genuine, backed by substantial amounts of money—£1 billion has been pledged for local authorities to support the local lockdown policy—and it is in all our interests to get this to work.

If it does not work, and if there is not the political leadership and trust at a community basis in the efficacy of this approach, we have only one choice. I am looking at the SAGE table which I have in front of me, and it is really clear. These kinds of tactical interventions can knock a point or two off R. However, the only way of knocking an integer off R is a national, home-based lockdown. That is the alternative: that we all go back to March and April, to being at home, with shops closed and no travel. If this local lockdown policy does not work, that is where we will end up, and that is why we are committed to working as hard as we can.

I pay tribute to the large number of those involved in local government at all levels who have worked really hard in their communities to make it work. We are here to talk about Lancashire, and I pay tribute to those in Lancashire who have agreed to and in fact called for the lockdown there. The noble Baroness, Lady Thornton, and the noble Lord, Lord Scriven, are right on the exit strategy. It is absolutely critical that everyone understands what the exit strategy is, and our focus needs to be on that. But I can tell your Lordships that it takes a lot longer to get out than it does to get in. The ramp up is a lot steeper than the ramp down, and it is a big struggle that will need the support of individuals, households, streets, communities, local authorities, regions, mayors and the national resources to make it work. I very much appeal for collaboration in this matter and hope that we can move on from what the noble Baroness, Lady Thornton, rightly characterised as a bit of an unseemly scramble this week.

The noble Baroness, Lady Thornton asked about shielding, which is incredibly important. We wrote to the shielding list on 13 October. That letter struck the balance between the need to protect those who are vulnerable and to take on board the feedback from many, including those in the Chamber today, that extreme shielding—locking up those who are vulnerable —does not support their mental health and will have massive consequences for them personally and for their communities. Therefore, the advice we have provided, in consultation with charities and groups representing those who are being shielded, strikes the right balance.

The noble Lord said something that I need to knock on the head in a big way, because it is a very destructive and counterproductive idea. He said that the fact that we are bringing in local lockdowns is itself proof of the failure of test and trace. That is simply not true. The only way to beat the virus is through the principal interaction of “hands, face, space”. You cannot break the virus’s spread entirely by isolating those who, retrospectively, you have identified as having the disease. That will never work, and we have never claimed it will work. SAGE and the Royal Society have been very clear that the impact of test and trace is complementary but it is not unique. The idea that local lockdowns are somehow solely and uniquely caused by the failure of test and trace takes the responsibility for beating the virus away from individuals, communities, employers, local authorities and the Government. With the greatest respect, I plead with the noble Lord to move away from that rhetoric, because it undermines the public communication of the importance of “hands, face, space”.

I return to my opening remarks. No one could take the development of these local lockdowns more seriously than the Government. It is done with huge regret. We can see perhaps the flattening of some numbers in some places that would indicate that local lockdowns are having an impact. It is too early to call at this stage. However, I live in hope that they will have the impact that we desire, and I live in fear that they will not.

[The Deputy Speaker (Lord Lexden) (Con)]

My Lords, we now come to the 30 minutes allocated for Back-Bench questions. I ask that questions and answers be brief so that the maximum number of speakers can be called.

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[Lord Bethell (Con)]

My Lords, I acknowledge the noble Lord’s reference to anecdotal reports and observational studies that have reported benefits of vitamin D in reducing the effects of Covid-19. We are absolutely keeping an eye on those reports. However, the clinical and evidential support for a clear link between vitamin D and Covid-19 recovery is not concrete or provable at this stage. None the less, in April, we reissued our advice on vitamin D supplementation, particularly to help those with musculoskeletal development needs, and we are absolutely keeping an eye on international developments with a view to investing in trials, should the evidential support for those arise.

[The Lord Bishop of Manchester [V]]

My Lords, the Greater Manchester tier 3 proposals were the main UK news item across our broadcasting media for at least a week. However, to the best of my knowledge, at no time did senior members of Her Majesty’s Government come to Manchester to meet its people, hear its voices and seek to reach an agreement face to face with our civic leaders. Moreover, yesterday the Manchester Evening News published a story claiming that senior leaders logged into one crucial meeting only to discover that the Government side had set up controls that did not allow members to unmute themselves. It then allegedly used that facility to prevent voices being heard.

Whatever the practicalities of managing virtual meetings —indeed, irrespective of whether the newspaper reports are wholly accurate—there is now a strong perception in the north-west that local leaders have been treated throughout this process with a great lack of respect. The affairs of Manchester and those of other regions cannot be settled from behind a computer screen in Westminster, one hand controlling the purse strings and the other the menu for mute, no more than can the proceedings of this House. I therefore ask the Minister and, through him, other senior members of Her Majesty’s Government, to commit to this House to coming to Manchester within the next couple of weeks to seek to repair the present breakdown in trust. We may bark loudly, at least when we are unmuted, but we rarely bite.

[Lord Bethell (Con)]

The right reverend Prelate makes a very touching appeal, and I reassure him that both the representatives and the people of Manchester are massively valued. I do not want to cite all the details, but many people in this Government, including me, have spent a vast amount of time in Manchester, value the city, love the people and are greatly distressed at the thought that anyone thinks otherwise. The practicalities of this epidemic have been very regrettable on travel. As a Minister, I regret massively the fact that I have not been able to travel up and down the country. It is not possible to visit cities for face-to-face negotiations in the middle of an epidemic. That would strike the wrong note. It is a contagious threat and that is not possible, but I reassure the right reverend Prelate that everything is being done to value the opinions of the representatives of Manchester, and it will continue to be so.

[Lord Herbert of South Downs (Con)]

My Lords, I agree with the Minister’s main point, which is that local lockdowns are really the only choice available to us at the moment if we wish to avoid a national lockdown—which will penalise those areas that do not have the relevant levels of Covid and cause further economic hardship—and are to reject those voices which, through things such as the Great Barrington declaration, suggest that there should be no restrictions at all other than shielding the vulnerable, which would exact a tremendous humanitarian toll. That being the choice, surely local lockdowns, backed by the relevant economic assistance, must be the current policy. If people are looking for bigger solutions, those ought to lie in the advance of either rapid testing or a vaccine. Can my noble friend update us on the potential timetable and likelihood of a vaccine and how prioritisation will be organised to ensure that it is available to those who most need it first?

[Lord Bethell (Con)]

The feedback from the Vaccine Taskforce is very promising. It has six contracts for vaccines on four different platforms. The Oxford vaccine is by far the front runner, but what is really encouraging is the substantial pipeline of other vaccines coming through. I am afraid I cannot commit to the timing on that, but all the news we have is extremely encouraging and we are putting deployment protocols in place to be able to deliver it as quickly as possible. I also flag that the therapeutic drugs and rapid testing also provide strong answers to the threat of coronavirus.

[Lord Blunkett (Lab)]

I have a similar declaration to the noble Lord, Lord Scriven, and agree with his comments on tests, where the 24-hour turnaround for tests has now dropped to 15% of the total. Perhaps the Minister could comment on the fact that, given the announcement this morning by the Chancellor, including the £2,000 retrospective contribution per month for those businesses not legally locked down and closed but which are being devastated by what is happening around them, it would have been perfectly reasonable to have reached a settlement with the Mayor of Greater Manchester, and it would be perfectly reasonable to expect the Sheffield City Region now to have its resource topped up from the £30 million that has been allocated to take account of that announcement this morning.

[Lord Bethell (Con)]

First, I am glad to say that we have struck a financial arrangement with the Mayor of Manchester, and one of the valuable points that I think the noble Lord is alluding to is that that agreement is fair to all the other regions where we have struck agreements. It is not possible to do more generous agreements with one region over another simply because of the hard bargaining of one mayor over another. I pay tribute to those in Sheffield and South Yorkshire for the way in which they have gone about their negotiations and the implementation of the new tiering system in South Yorkshire.

[Baroness Jolly (LD) [V]]

My Lords, as was shown in Manchester, the Government can impose tier 3 on an area where an agreement cannot be reached. Can the Minister inform the House if discussions with local leaders are now about not whether the area will be placed in tier 3 for the good of the population’s well- being but the financial package?

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[Lord Bethell (Con)]

My Lords, it is with great regret that central government imposes lockdowns under the tiering arrangement. In all the other areas where we have put in local restrictions, it has been done either at the immediate and clear request of the local authorities or in close collaboration with them. That is our intention going forward: we do not intend to impose anything. In fact, the considerable time lag in Manchester, which, as everyone, took many days before the imposition of restrictions, was extremely regrettable, and we will reflect on the cost of that to the community in Manchester at a future date.

[The Deputy Speaker (Lord Lexden) (Con)]

Both the noble Lords, Lord Robathan and Lord Desai, who are next on the list, have withdrawn, so I call the noble Baroness, Lady Barker.

[Baroness Barker (LD)]

Will the Minister explain to the person in Sheffield who, having registered themselves as being positive for Covid, was contacted four times a day for four days on the trot, and managed to stop it only when they got the nurse to explain that they were so ill that they were in hospital, how their statistics will be recorded by Serco? Can he explain to the people of Sheffield why the Government continue to spend so much money on a system that is so bad?

[Lord Bethell (Con)]

The noble Baroness alludes to a glitch that the noble Baroness, Lady Thornton, raised yesterday, which I looked into overnight at her suggestion. It is true that if someone lives in a household with several other people who have been reported to have Covid, they are, at the moment, each receiving emails or calls, not on a household basis. We are looking at this and I hope to have it fixed in the next few days. I am grateful to the noble Baroness, Lady Thornton, for raising it.

[Baroness Andrews (Lab) [V]]

My Lords, scientific evidence now suggests that one of the reasons for the spike in cases in the northern regions is due to the fact that Covid has been more virulent and persistent there, and that restrictions were lifted too soon. What have the Government learned from that? Returning to the questions asked by my noble friend Lady Thornton, what will be the criteria in determining when it will be safe to move from the latest restrictions? The Minister spoke movingly of how fearful he was that they would not work. Difficult though it is, the question is: when will we know whether they are working? What will be the elements and criteria of the exit strategy?

[Lord Bethell (Con)]

My Lords, the exit strategy question is extremely important and I am grateful to the noble Baroness for raising it. We have not published strict criteria for each exit strategy for moving from one tier to another. It is part art and part science, in any case. We look at a large number of indices, including hospitalisation, transmission and incidence rates, and so on. What the Government and local authorities can do is to figure out local Covid plans with inherent exit strategies. We will be working on those as a matter of priority.

[The Deputy Speaker (Lord Lexden)(Con)]

The noble Baroness, Lady Pidding, who is next on the list, has withdrawn , so I call the noble Baroness, Lady Blackstone

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[Baroness Blackstone (Ind Lab)]

My Lords, what steps are the Government taking to increase NHS lab capacity for testing in areas suffering from new restrictions? What advice has been given to care homes in those areas to alleviate the appallingly inhumane denial of access of families to their elderly relatives? For example, will regular testing be made available to those visiting their desperately lonely and sometimes confused relatives in care homes?

[Lord Bethell (Con)]

I pay tribute to NHS colleagues who have done an enormous amount to increase NHS lab capacity, and would be happy to share the numbers with the noble Baroness. We have written to care homes to emphasise the critical importance of the pastoral visits to which she refers. There is no question of a care home shutting out visitors if it can be avoided and we are putting regular testing in place to protect care homes. We are looking at providing regular testing for visitors and hope to make progress on it.

[Baroness Jones of Moulsecoomb (GP) [V]]

My Lords, I take issue with the Minister’s response to the Front-Bench spokespeople when he urged everyone not to make party-political points during this pandemic, yet went on to swipe at Andy Burnham, the Mayor of Greater Manchester. The Minister needs to hold himself to the same high standards he urges on others. This Government promised to level up the north but all we are getting so far is the north being put into tier 3 lockdown and given £8 per head in compensation. When are they going to come up with a long-term economic plan? We have record low interest rates and this is the time to borrow and invest if we are to have any sort of green, productive future.

[Lord Bethell (Con)]

I am grateful to the noble Baroness, who has clearly read the Conservative Party manifesto. I should be grateful for her recommendations on how we can do exactly what she suggests.

[Lord Haselhurst (Con) [V]]

While I warmly welcome the measures announced by the Chancellor this morning, which should ease the lot of people working in the hospitality sector in South Yorkshire and elsewhere, has there been any assessment of any negative impact on public health if restaurants—which, by definition, provide substantive meals—were allowed to stay open until 11 pm, in order to accommodate two sittings, a factor that they say is crucial to their viability in many cases?

[Lord Bethell (Con)]

My Lords, having worked in the hospitality industry for 10 years, I feel great kinship with restaurant owners but cannot avoid the fact that restaurants represent a major focus for transmission. Sitting opposite someone and having a long meal for a couple of hours, sharing the same air and space, presents a massive risk. There is no question that this is a substantial cause of the introduction of the disease into new households and we stand by the 10 pm curfew as introduced.

[Lord Rooker (Lab) [V]]

Should not Greater Manchester receive a backlog payment for tier 2 funding for the past two months, now that London has received one after two weeks? Given that the Government have got the UK into the world-leading position of third in most new cases, fifth in most deaths and sixth in deaths per million, why has no scientific adviser or Minister resigned over that appalling killing record?

[Lord Bethell (Con)]

My Lords, I am glad to reassure the noble Lord that Manchester businesses will be getting a payment to cover the backlog, as he described.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, my city, Sheffield, and the South Yorkshire region have been mentioned a great deal today. My specific question, of which I have given prior notice, comes from the Green councillors there but is, sadly, of interest to an increasing number of areas of the country. When can the funding for tier 3 areas be expected to arrive? Will it be in regular tranches or a lump sum? When can it be expected to reach businesses? Are conditions attached to the money and its continuation?

[Lord Bethell (Con)]

My Lords, grants will be available from 1 November, will be administered by local authorities and will remain in place until April 2021, with a review point in January. The funding will apply only to England and, if applied across the country, would provide over £250 million of support each month.

[Lord Dubs (Lab) [V]]

The Minister was asked about exit strategies from tier 3 or any of the tiers. He said that the answer was part art and part science. Will he assure us that that does not mean that when the Government do not feel like accepting science, they will simply be vague and ignore what the scientists say? He also referred to travel. Has he looked at the position at German airports, a point raised with him yesterday or the day before? Can we look again at checking people on arrival at airports? I know that one cannot be sure but checking on arrival and again a few days later would prevent the need for long periods of quarantine that are difficult for people to cope with. They may lose a lot of money and their jobs. Can we look again at this?

[Lord Bethell (Con)]

The noble Lord is right that the situation at airports is distressing and has caused huge damage to travel, the airline business and hotels. However, foreign travel represents a massive threat in forward transmission of the virus. Testing at airports catches only a tiny proportion of those infected, and quarantine arrangements are not wholly reliable. For that reason, we are running a pilot in the UK to see what can be done but we will tread cautiously.

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

My Lords, the Minister has said that he will not publish the criteria under which a local area can move in and out of a tier. Does he agree that publishing some indication would give local people a clearer understanding of what needs to happen to move out of a tier? Perhaps I may refer to the proceedings of the Secondary Legislation Scrutiny Committee earlier today, which, looking at the tiered approach, said, “For public trust to be maintained, the Government have to be much more transparent in explaining the basis of their decision-making, including setting out how they balance the competing health, social and economic interests and the data to support the decision.” Will the Minister look at this?

[Lord Bethell (Con)]

My Lords, I hear the point loud and clear from both the noble Lord and others who have raised it. The question of the exit strategy is a priority and it is inevitable that people will be asking exactly that. We have sought hard over recent months to make the regulations clearer, simpler and more understandable for the public; the rule of six, the tier strategy and other measures are efforts to do that. However, his point about exit strategies is extremely well made and I would be glad to take it back to the department and to push as hard as I can on it.

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

Lord Bethell Excerpts

Thursday 22nd October 2020 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 28 September be approved.

Relevant document: Special attention drawn to the instrument by the Secondary Legislation Scrutiny Committee, 29th Report.

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

My Lords, this instrument sets out the regulations on the legal duty to stay at home and self-isolate for people who test positive for Covid-19 and their contacts who are told to self-isolate by NHS Test and Trace, which came into force on 28 September. The principle of self-isolation is a key component of our strategy to break the chain of transmission, which in turn stops the spread of the virus, protects individuals and local communities and avoids further societal and economic restrictions. The legal requirement in this statutory instrument is to make it crystal clear to the public—more than any marketing, published guidelines or televised Downing Street presentation possibly could—that people who are infectious or potentially so should stay at home and self-isolate. Providing this clarity about the right thing to do is an essential step to securing a more normal way of life and supporting the economy.

On the scientific substantiation for this strategy, perhaps I may reassure noble Lords that SAGE has advised that ensuring that infected individuals and their close contacts isolate is a vital tool in controlling transmission. Faced with the current rising incidence levels, it is the right time to provide this clarity. Positive cases have increased sharply, with seven times as many cases compared with the end of August. Since it was launched on 28 May, 290,034 people have tested positive and have had their cases transferred to NHS Test and Trace. Some 1,198,151 contacts have been identified and 82% of those for whom contacts have been given have been reached and told to self-isolate. These are astonishing figures. The most recent weekly statistics for 8 to 14 October show that 101,494 people tested positive during that week at least once, an increase of 12% compared with the previous week. I cannot emphasise enough how important it is that those people should self-isolate when instructed.

We are naturally concerned about compliance levels. We cannot knock on 1 million doors every day for 10 days for each person when they are isolated, so we cannot be certain about compliance levels. However, there is enough evidence to suggest that it is not good enough and we have a programme in place of measures to improve it. The first is to increase public understanding of the importance of self-isolation in stopping the spread of the virus. We have put in place a comprehensive media campaign to explain what test and trace is, why it is important and what the public need to do when they are told to self-isolate.

I thank the Secondary Legislation Scrutiny Committee for its important review of this SI and its impact on the public’s understanding, and I acknowledge the committee’s comments on the importance of that. However, I point out that the SI is part of a broad effort to simplify and clarify the rules, which includes the introduction of local alert levels in England and the rule of six.

Secondly, we are supporting people to self-isolate by providing assistance to those who may have practical difficulties in self-isolating. NHS Test and Trace will check with individuals who test positive and their contacts to reinforce the importance of self-isolation. They will ensure that they have access to any support needed. Since 28 September, contact tracers have made around 35,000 to 50,000 calls a day to people who are self-isolating.

The £500 test and trace support payment has been introduced to ensure that people on low incomes self-isolate when they test positive or are identified as a contact, and to encourage more people to get tested. Eligible individuals receive an up-front, one-off payment of £500. This is on top of any benefits and statutory sick pay that they may currently receive. The Government set a deadline of 12 October for local authorities to be ready to administer the test and trace support payment scheme.

Local authorities are now making payments to people on low incomes to support them to self-isolate. We are monitoring the situation to ensure that national coverage is in place. I acknowledge that a small number of local authorities are experiencing technical difficulties in administering the scheme, as we would expect with a programme set up so quickly. We are supporting them to resolve these issues as soon as possible. In addition to the support payment, local authorities will focus on the principle of encouraging, educating and supporting self-compliance.

Thirdly, we are introducing fixed penalty notices for those who do not follow the rules to send a clear message about the seriousness of not self-isolating. Penalties and offences were designed in conjunction with legal colleagues, consulting previous precedents. During this process, the Department of Health and Social Care worked closely with the Home Office, the National Police Chiefs’ Council and the Government Legal Department to agree the memorandum of understanding. The Information Commissioner’s Office has also advised on the process of information sharing involved to ensure data is shared appropriately and proportionately. BEIS and MHCLG also supported the decision-making around enforcement methods and processes. Fines start at £1,000 and may increase up to £10,000 for repeat offenders. For more serious breaches, fines start at £4,000, increasing up to £10,000.

We have needed to use emergency powers to introduce these regulations so that we can respond quickly to the increased threat posed by Covid. The urgency in this case arises from the increasing rate of diagnosed positive cases at the time of making the instrument. The Secretary of State for Health and Social Care keeps the necessity of regulations under consideration between formal review points. We are committed to ensuring that these measures are in place only for as long as necessary.

The requirement on people who are notified to self-isolate plays a key role in slowing or preventing the spread of the virus. The regulations will protect individuals and their loved ones. They will help to ensure that we keep the virus under control. For that reason, I beg to move.

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[Lord Touhig (Lab) [V]]

My Lords, I thank the Minister for introducing this instrument, although I must put on record my concern that we are only now able to debate these regulations, almost four weeks after they came into effect. Moreover, it is simply unacceptable that this instrument came into force a mere seven hours after it was laid on a Sunday evening. Given that it contains significant requirements and penalties for individuals and employers, a lead time would have been reasonable to communicate these changes to the public and encourage compliance.

The Government say that these regulations are necessary precisely because there have been low levels of compliance. A study commissioned by the Government found that just 18% of people who had symptoms went into isolation. Why was this evidence not included in the Explanatory Memorandum? Is it because the Government are embarrassed by their record? The low levels of compliance must be viewed in the context of the failure of the Government’s test and trace system. The most recent weekly statistics show that only two-thirds of people who tested positive were transferred to the contact tracing system. How can we possibly expect people to self-isolate if they are not contacted?

It beggars belief that what was called Britain’s world-beating app, costing tens of millions of pounds, was finally rolled out months later than promised and is unable to operate on phones more than five years old. This world-beating app cannot accept all coronavirus test codes; it struggles to calculate distances and does not require people to self-isolate. Can the Minister explain why the app, a vital tool in the fight to contain coronavirus, is not part of these regulations?

While I understand the data and privacy concerns, the Government appear to have no qualms about sharing information obtained through the contact-tracing programme with the police—a point made by a number of colleagues. The Secondary Legislation Scrutiny Committee pointed out that those informed by the app could avoid being fined for failing to self-isolate if they do not follow up the notification by applying for a test. Who would know? A number of colleagues today have also made that point. Does the Minister accept that excluding app users is ineffective and discriminatory? It is discriminatory because those who do not have access to the app are more likely to be identified by track and trace, and to be fined.

The Government have said that people on low incomes who cannot work from home and have lost income will be eligible for a new £500 test and trace support payment. With around 4 million people in receipt of benefits in England expected to be eligible for this payment, we welcome this support, however belated its introduction was. However, the Health Minister, Helen Whately, said that only 60 people had received a £500 payment as of last week—60 out of a potential 4 million people. How many people have applied and how many are awaiting a decision for this compensation and support? This is important because these regulations require our fellow citizens to act and do the right thing. The effective delivery of financial support where it is needed is therefore vital to ensure that no one is pushed into poverty for doing the right thing.

[Lord Bethell (Con)]

My Lords, I am enormously grateful for a debate that shed a huge amount of light on an issue which acutely illustrates the delicate task that we and a lot of liberal democracies face in fighting Covid: on the one hand, balancing the preservation of life and the difficult public health measures necessary to protect it with, on the other, our liberty and freedoms, the livelihoods we need and the love of family and friends that we enjoy. I believe that these measures do strike the right balance, but this debate has rightly raised important questions about whether we have hit exactly the right point. I will address a few of those.

I reassure all noble Lords that these measures in no way seek to instigate some kind of mass fining or punishment regime. They are about supporting the principle of isolation, to ensure that there is absolute clarity about its meaning and the requirements expected of people, and to give the authorities the powers to enforce these—if absolutely necessary and only in the most extreme circumstances—when they have been most overtly breached.

We recognise that the people who are breaching isolation have not respected a clear and simple public health message in the first place. It is, therefore, not our policy to believe that they would necessarily be motivated by the threat of a fine. Instead, we seek to support people in a number of important ways and to educate them on the importance of isolation. We remain committed to the principle of consent, wherever possible, and we believe in the good nature and good intentions of the British public. That support has been enhanced by a payment of £500. The noble Lord, Lord Touhig, asked about the number of payments. Those payments are being made by local authorities and we are putting in place the measures necessary to count the number being made.

A number of noble Lords asked about the precise nature of isolation: how long should you isolate for; what is isolation; what are the requirements of those who have been asked to isolate? In the last five months, we have taken a large number of genuinely complex measures through the Chamber. This is not one of them. The protocols around isolation are clearly spelled out. If anyone needs to, they can look at GOV.UK/coronavirus or google “Do I need to isolate?” They will see, spelled out in very clear terms, the timing of the isolation, what is required when you isolate and the support you get when you do. I take with a large pinch of salt the suggestion that this is not clear.

What is definitely true is that isolation is a big challenge. For those in casual work, it may have a massive impact on their income. For those with families to support, it hits their ability to look after them. I do not doubt that it is an onerous obligation, but it is a necessary one, because there is no other way of breaking the chain of transmission. If those with the disease travel in our community and share the virus with those they love or pass by, we will never contain it. If people adhere to isolation, the regime of local lockdowns and of hands, face, space, stands a chance of being effective. We believe that it is effective on the great majority of occasions and we applaud the British public for their adherence.

We have sought not to make these measures draconian. There are exemptions for travelling for food and medical emergencies and for other reasons. As I said, there is support from NHS volunteers, statutory sick pay and discretionary payments from local authorities.

A number of noble Lords raised the impact on the elderly, and I hear their concerns loud and clear. It is without doubt that the Covid regime puts a huge emphasis on digital communication, whether that is getting information from websites or the app itself, which is available on 89% of phones. The elderly undoubtedly have a larger proportion of the older phones or have not updated their technology recently. However, the lack of the app does not necessarily mean that you are somehow excluded from the isolation protocols. The 111 telephone facility is enormously helpful and has proved hugely successful. We have given local authorities special support to reach out to the elderly to ensure that they have both the necessary support under isolation and the information to understand the protocols.

A number of noble Lords mentioned the impact on children. The impact on their mental health is enormous, which is why we are supporting local authorities and charities with funds. The noble Baroness, Lady Meacher, asked about testing in schools. I reassure her that we have, today, started a large set of pilots, first in Stoke and then in a number of schools up and down the country, to try to use testing in a much smarter way in order to keep schools open.

The noble Baroness, Lady Altmann, mentioned the pressure on families and the discipline needed in schools. She made her point very well: it is my personal lived experience and I have no doubts about that pressure. However, I cannot avoid the fact that containing this virus does require us to stop the chain of transmission, in children as well as everyone else.

The noble Lord, Lord Adonis, asked a number of pertinent, thoughtful and detailed questions. I will be happy to write to him with answers to some of them. I reassure him that, although the Welsh may have closed secondary schools, it is very much our intention to keep the schools in England open. On inspecting online learning, on 6 October Ofsted published the first of a new series of briefings looking at how schools are managing pupils’ return, including online learning. The Department for Education has made available an initial 250,000 additional laptops and tablets for children who need them. On wi-fi, the department has delivered over 50,000 4G wireless routers to support disadvantaged children in accessing remote education and vital support services.

There were a number of other detailed questions that I will be glad to write to noble Lords about. The noble Lord, Lord Hain, made a number of points, not all of which I completely agree with, but he is absolutely right that there is a balance to strike between speed and quantity. We have massively increased quantity and will continue to do so, but we have a case to answer on the turnaround time of our tests. The noble Lord is right that turnaround time is very important.

In conclusion, the noble Baroness, Lady Jones, set me a challenge about what we can do to “build back better”. Those were not her words but the Prime Minister’s, but they capture rather well her intention regarding the investment needed to address the levelling-up agenda and the damage done by Covid. I am afraid that I do not run the Treasury, so I cannot necessarily meet with her economists.

However, there are a number of resonant themes in the healthcare sector regarding the way in which Covid will actually lead to improvements in our healthcare system if we take the right measures now to capture that progress. I get reports from the front line about an enormous culture of collaboration between different parts of the healthcare system, which is refreshing and impressive. That is exemplified by the sharing of data. Although we have not changed the guidelines or rules on data sharing, we have hugely encouraged it, which has helped with treatment and therapeutics. The renaissance in the diagnostics and pathology professions, and the investment in a large amount of diagnostic kit, is going to have a huge impact on early interventions in disease. The investment and progress we have made in vaccines and therapeutics demonstrates Britain’s leadership role in and the value of science, and illustrates the huge return on the British taxpayer’s investment in science. It is a sign of how we should take things from here.

Motion agreed.

Cancer Task Force

Lord Bethell Excerpts

Tuesday 20th October 2020 Lords Chamber

[Lord Rennard]

To ask Her Majesty's Government how the new cancer taskforce will operate; and what funding that taskforce will be able to direct towards reducing any backlog in identifying and treating cancer patients.

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

My Lords, the Cancer Recovery Taskforce’s role is advisory, to oversee the development of a national cancer delivery plan due to be published later this autumn. The task force is chaired by Professor Peter Johnson, the national clinical director for cancer. It met for the first time in September and is due to meet again on Thursday. Membership is drawn from across the cancer community, and I thank all of those involved. NHS Improvement has recently confirmed annual funding allocations of £153 million for 2021 to the cancer alliances in England.

[Lord Rennard (LD) [V]]

My Lords, I refer to my interests as in the register. Cancer Research UK and Macmillan have reported that 2.4 million people are now waiting for screening, tests and treatments for cancer services. The Commons Health Select Committee has reported that the number of MRI and CT scans to diagnose the disease has plummeted by 75%. Given that the Government spend on average half as much on capital in healthcare compared to similar countries, what is the scale of the investment over the next year that will be specifically allocated for the latest technologies and additional staff to deal with the backlog of cancer diagnosis and treatment?

[Lord Bethell (Con)]

My Lords, the situation raised by Cancer Research UK and others causes concern, but I reassure the noble Lord that we are doing more than a million routine cancer appointments and operations per week to catch up with the backlog. Urgent two-week waits for GP referrals are back to almost 85% of pre-epidemic levels and we have a massive plan to address this, which includes the creation of Covid-secure environments, switching to new drugs for those who cannot make it to hospital, the judicious use of radiography, targeted messaging to those who may suffer from the symptoms of cancer, the use of rapid health diagnostics, an alliance with charities, a cancer recovery plan and enhanced monitoring on a single version of truth basis of our progress on this important issue.

[Baroness Thornton (Lab)]

My Lords, I would like to follow up on the Question of the noble Lord, Lord Rennard, which was about investment. The UK spends on average half as much on capital in healthcare compared with similar countries, so the average number of MRI and CT scanners is well below the OECD average per million of population. Does the Minister agree that to tackle the cancer backlog and improve survival outcomes the Government must also implement the recommendations of Sir Mike Richards’s recent review into diagnostics and significantly invest in the necessary diagnostic equipment?

[Lord Bethell (Con)]

The noble Baroness is right to raise the excellent report by Professor Sir Mike Richards into cancer diagnostics. We have taken that report on board and are studying it very carefully; it will inspire us tremendously. As I mentioned earlier, £153 million has been allocated to cancer alliances. The investment in capital is an extremely important part of that. I want to flag a few immediate developments: diagnostic capability at the Harrogate and Exeter Nightingale hospitals, the community diagnostic hubs and the rapid diagnostic centres are all in focus for this investment.

[Lord McCrea of Magherafelt and Cookstown (DUP) [V]]

My Lords, with radiotherapy being needed for over 50% of cancer patients and involved in 40% of cancer cures, what is being done to ensure that patients can continue to access this life-saving treatment throughout the Covid-19 pandemic? Are there plans to improve access to radiotherapy for the 2.5 million people currently living over the recommended 45-minute travel time to bring cancer treatment closer to people’s homes?

[Lord Bethell (Con)]

My Lords, during the Covid pandemic, radiotherapy services have continued. We are working to ensure that the need to travel to hospital is kept to a minimum, using drugs where they present an alternative to radiotherapy. The recovery of our radiotherapy services is massive and we are using the latest technology to ensure that this is delivered as impactfully as possible.

[Lord Flight (Con)]

My Lords, is the cancer task force, now in the fifth year of its five-year programme, to become a permanent organisation? What is the basis for allocating funding and research?

[Lord Bethell (Con)]

My Lords, the Cancer Recovery Taskforce I refer to is the group of people focused specifically on the recovery from the Covid pandemic. The overall cancer recovery programme will be published later in the autumn, and it will have budgets associated with it.

[Lord Addington (LD)]

My Lords, the whole thrust of the Covid pandemic has been to make sure that the NHS stays in one piece. As we have fewer people referring to their GPs and fewer people being referred into the system, are we not creating a backlog that will affect the NHS’s capacity to deal with problems? With that in mind, what will the Government do to ensure that people know that it is safe, or at least that the risk is low, to go to a GP in the first place and then go on to hospital?

[Lord Bethell (Con)]

The concern is serious. However, I reassure the noble Lord that although those waiting longer than 62 days for an urgent GP referral increased to about 21,000 between the end of March and the end of May this year, it now stands at about 8,000, which represents a dramatic decrease in the backlog. We have invested in the “Help Us Help You” campaign, which is directed specifically at those who are most at risk from cancer. It is a massive campaign that we are rolling out shortly, and we will continue to invest in it if that is needed.

[Lord Balfe (Con)]

My Lords, calculations by the charity Action Radiotherapy suggest that the cancer treatment backlog may cost more lives than the coronavirus itself—indeed, it estimates that it could be as high as 100,000. Can the Minister give us details—and if not, can he place them in the Library—of the investment in and expansion of radiotherapy services that is being considered and of the aim to reduce the number of machines that are beyond their 10-year lifespan?

--- Later in debate ---

[Lord Bethell (Con)]

My noble friend is entirely right. The impact on cancer from Covid is extremely concerning. However, the backlog is being dealt with more quickly than the immediate figures perhaps suggest. The investment in radiotherapy is incredibly important; we have new treatments coming in all the time, and I reassure my noble friend that we will be retiring redundant machines as soon as they reach the end of their natural lifespan. I want to mention in particular stereotactic ablative body radiotherapy for small cell lung cancer and oligometastatic indications: I am told that this is a particularly exciting radiotherapy treatment

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

Following on from that, does the Minister recognise that about half the machines in the country are currently beyond their 10-year lifespan and urgently need replacing—including upgrading to provide stereotactic radiotherapy, which has lower side effects and better outcomes—and that there therefore needs to be at least £230 million ring-fenced for innovation in radiotherapy, quite apart from the other investments?

[Lord Bethell (Con)]

The noble Baroness puts her case extremely well. We have a massive investment in the NHS that spans physical infrastructure and staff, hospitals and investment in nurses. This will have a big impact on the diagnosis of cancer, which we are committed to getting as early as possible, as well as on treatment for cancer. Treatment with radiotherapy will form an important part of that.

[Lord McColl of Dulwich (Con) [V]]

As there has been much more exposure to the sun this summer, there will be a greater incidence of melanoma. Does the Minister agree that screening is essential to detect melanomas before they spread rapidly and are fatal? If they are detected while they are less than 0.6 millimetres deep, they can be cured by a simple removal under local anaesthetic. Does he agree that this ought to be a priority for the task force?

[Lord Bethell (Con)]

My Lords, I completely and utterly agree with my noble friend.

[Lord Woolf (CB) [V]]

I am pleased to hear of the arrangements made for treating the backlog of patients suffering from cancer. However, that is not the only backlog that exists; other conditions require urgent attention. I disclose the position of my 24 year-old grandson, who is studying for a doctorate in epidemiology. He was born with a condition which meant that, at a very early age, he had to be fitted with a pacemaker. Unfortunately, when changing his pacemaker, the wiring was found to have become embedded in his heart. It was therefore decided to leave the wiring in that position and to fit a second pacemaker. Towards the end of last year, his health deteriorated. He was eventually admitted to the Brompton hospital, and by that time was in a very serious condition. Fortunately, after five weeks in an induced coma, his condition dramatically improved and he should make a full recovery. However, it was touch and go. I make no criticism of anyone, but it is important that it is not only cancer that is regarded as important; other patients should also be regarded as important.

--- Later in debate ---

[Lord Bethell (Con)]

I thank the noble and learned Lord for sharing that moving testimony. The broad point that he makes is entirely right—that Covid has an impact on our healthcare system that goes way beyond those who have Covid. It has an impact on the care and outcomes of all sorts of people who need important places in the healthcare system. That is why this Government are committed to the suppression of the virus and to protecting the NHS, and it is why, on behalf of everyone, we wish both the noble and learned Lord and his grandson well.

[The Lord Speaker (Lord Fowler)]

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

Covid-19: Information Sharing with Police Forces

Lord Bethell Excerpts

Tuesday 20th October 2020 Lords Chamber

[Lord Hunt of Kings Heath]

To ask Her Majesty’s Government what is the legal basis for their Memorandum of Understanding with the National Police Chiefs’ Council which allows police forces to access information that tells such forces if a specific individual has been told to self-isolate due to the COVID-19 pandemic.

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

My Lords, the Health Protection (Coronavirus, Restrictions) (Self-Isolation) (England) Regulations 2020 authorised the police, local authorities and NHS Test and Trace to share information where necessary for the purposes of enforcement. The Department of Health and Social Care and the National Police Chiefs’ Council have agreed a memorandum of understanding so that, when given a report that someone is failing to self-isolate, the police can check with NHS Test and Trace whether the person in question has been formally notified to self-isolate.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am grateful to the Minister but does he agree that sharing what is essentially health information with the police is a highly sensitive matter? This should not have been sneaked out on a Friday night without any parliamentary reference whatsoever. Was NHS experts’ advice taken regarding the impact this might have on people prepared to take the test? Is the Minister aware of the advice given by the BMA and other health service organisations, particularly in relation to harder-to-reach communities, that this may dampen down the numbers of people coming forward for tests? Was that taken into account?

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I reassure the noble Lord that no health information is shared. This is isolation information, not health information. I can tell that the noble Lord is not happy with that. I reassure him that people are asked to isolate for a number of reasons: it might be because they tested positive, or because they were close to someone who tested positive, so the fact that they have been asked to isolate has got nothing to do with the state of their health.

We are discussing this regulation on Thursday. That will give us an opportunity to go into it further, which I look forward to very much indeed. On the impact of taking the test, we have looked at public attitudes to the principle and enforcement of isolation. It enjoys an enormous amount of public support, and I think the noble Lord underestimates those in the BAME community and their response to this responsible approach to isolation.

[Lord Morris of Aberavon (Lab) [V]]

I welcome the principles set out in the memorandum of understanding on prosecutions, and Regulations 12, 13 and 14. In particular, I welcome the fact that there will be regular reviews, both locally and nationally, so that lessons can be learned. Will the reviews be published, and will the Minister confirm that there is a 12-month limit on prosecutions if evidence is available?

[Lord Bethell (Con)]

My Lords, those are two very important and clear questions. However, I will have to take them back to the department and write to the noble Lord with very clear answers.

[Lord Scriven (LD)]

My Lords, despite what the Minister says, this memorandum of understanding has undermined some people’s trust in test and trace. The best way to deal with that is to shed the light of transparency on to what is actually in the MoU. Therefore, will the Government commit to publishing it?

[Lord Bethell (Con)]

My Lords, I commit to publishing the memorandum of understanding; that is our intention. It has to be cleared of some officials’ names and redacted accordingly, and, when we have gone through that process, we will publish it. I will address the noble Lord’s central point, which is very reasonable, and I am glad he made it because he and the noble Lord, Lord Hunt, are entirely right: there is a balance here between the principle of consent, which is how we went about implementing a great many of our measures, and the principle of effectiveness.

We are quite late now in the stage of the epidemic. I think it reasonable to demonstrate the seriousness of the principle of isolation, to make what isolation means crystal clear—and, therefore, in statute—and for the sanction of the law to apply to those people who do not have a responsible attitude and have behaved irresponsibly. It is not our intention to rack up a large number of prosecutions in this area, as it has not been in other areas. However, it is our intention to be clear and determined and to make this incredibly important part of our breaking the chain of transmission as effective as possible.

[Baroness Lane-Fox of Soho (CB) [V]]

Understandably, this news has caused much confusion: you only need to take to social media to see people’s anxieties. As I understand it, the app keeps all data locally on your phone and only when you upload a positive test does it then become more widely available, although anonymised. What measures are the Government going to take to make sure that communications are crystal clear, so that people can totally understand the privacy implications of what they are doing? It seems there is still much anxiety about exactly what can be done.

[Lord Bethell (Con)]

I am grateful to the noble Baroness for her insight, but I reassure her that the information on the app is not covered by this memorandum of understanding. That is a principle that has been made very clear by the NHS app. This is the data held on CTAS, the Public Health England database, and it remains the property of Public Health England; the MoU is very specific about that. As the noble Baroness is aware, the app is a distributed source of information; it has extremely high privacy barriers, and this MoU does not in any way breach those barriers.

[Baroness Thornton (Lab)]

It is disingenuous for the Minister to say, in answer to my noble friend Lord Hunt, that this is not a health issue. Following on from the question of the noble Baroness, Lady Lane-Fox, I imagine the police will have been concerned about the implications for data protection for both themselves and individuals. Therefore, I ask the Minister how personal data that is being handed over to the police is going to be stored. Who will keep it and how will it be handled? Are any discussions on data-sharing taking place or planned involving the Department of Health and Social Care, and the Home Office or Cabinet Office?

[Lord Bethell (Con)]

My Lords, the data collected by PHE for the test and trace service is held, as I said, by the Contract Tracing and Advisory Service database—the CTAS database—and it will be provided to the police on request. It is not a question of a wholesale sharing of all data. The data that can be shared with the police are the recorded name and contact details of an individual who has been instructed to self-isolate, the date on which they were told to self-isolate and the date on which the period of self-isolation ends. No testing data or health data are shared with the police at all.

[Lord Mann (Non-Afl)]

Do we have a defined national police strategy on the policing of breaches of self-isolation, or will we see a patchwork of implementation by different chief constables across the country?

[Lord Bethell (Con)]

I thank the noble Lord for his question. The intention of this legislation is threefold: first, to increase public understanding of the importance of self-isolation; secondly, to help to support people to comply with self-isolation by making sure that they understand the consequences of breaking those rules; and, thirdly, to introduce fixed penalty notices for those who do not follow the rules. Our intention is not to enforce a surveillance culture around this; it is instead to leave it to members of the public to take it into their own hands as to whether they would like to share instances of breaches with the police, and to give the police an opportunity to follow up those reports in a timely, accurate and efficient fashion.

[Baroness Jones of Moulsecoomb (GP) [V]]

My Lords, in an earlier answer to the noble Lord, Lord Hunt, the Minister seemed to suggest that the noble Lord was casting aspersions against the BAME community with regard to their willingness or not to sign up because of data-sharing with the police. Would he like to take back that slur? Could he also please tell me which BAME communities he spoke to before imposing these conditions?

[Lord Bethell (Con)]

I am grateful for that important question. At no point would I ever wish to cast any aspersions or slur at the noble Lord, Lord Hunt, who I count as a close colleague and someone whose opinion I respect enormously. However, I was replying in response to his question about BAME communities. We are deeply involved in talking to a large number of those communities, which have traditionally been hard to reach. We are engaged with them on many levels to talk to them about how we can address the marketing challenge of getting our messages to them, how we can shape our messages so that they are fully understood, and how we can address any concerns they may have about the test and trace programme.

I can report to the noble Baroness that we have been extremely pleased by the very encouraging responses that we have had from those communities, which is why I do not think it is reasonable to assume that any particular community would be more or less suspicious of this programme than another.

[The Lord Speaker (Lord Fowler)]

My Lords, all supplementary questions have been asked, and that brings the Private Notice Question to an end.

Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 5) Regulations 2020

Lord Bethell Excerpts

Tuesday 20th October 2020 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 24 September be approved.

Relevant documents: 26th Report from the Joint Committee on Statutory Instruments (special attention drawn to the instrument) and 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, it was necessary to make these regulations against an increase in transmission at local and national level. Although the new local alert regulations have since superseded many of the provisions of the regulations, I welcome the scrutiny from this House on the changes that they brought in and, in particular, on key aspects that remain in force. These include regulations that introduced the 10 pm curfew in these areas—a measure that has attracted considerable interest in the Chamber, and I welcome the opportunity to give this component of a broad suite of important measures the scrutiny that it deserves.

The regulations, SI 2020/1029, tightened the No. 2 regulations in key respects that have attracted considerable comment. The important modifications were necessary due to an increase in the prevalence of the virus. The ONS estimated that coronavirus had doubled in this area in the month up to 13 to 19 September to one in 500 people. From Thursday 24 September, the day that the SI was made, the following changes came into force: early closure of premises selling food and drink between 10 pm and 5 am, the restriction in relevant hospitality venues to table service, the removal of exemption to the rule of six for adult indoor sport, new penalties on individuals for breaking the rules to a maximum of £6,400, and some other measures. Changes from Monday 28 September included changing the exemption to the rule of six for weddings and wedding receptions to a limit of 15 people, limiting life-cycle events to six people, and raising penalties to a maximum of £10,000 for businesses that are not following Covid-secure guidelines.

SI 2020/1057 came into force on 30 September with two main aims. First, it introduced household mixing restrictions in all indoor settings. The regulations prevented people from mixing with other households in any indoor settings, including venues such as pubs and restaurants. The regulations also moved local authorities in Merseyside and Lancashire from the north-east and north-west regulations into the north of England regulations, so that those areas were not subject to the additional household mixing restrictions. Secondly, that SI amended two sets of national regulations by disapplying some gathering provisions and defining “indoors”, which was necessary to bring parity to the rules for indoor settings.

Most of the amendments in both SIs are no longer in force because the local alert-level regulations have replaced them. However, SI 2020/1029 is still required because it increases the level of fines that would apply to those flouting targeted action to close specific outdoor public places. This has been one of the top demands of councils in their fight against coronavirus. Similarly, a majority of the measures in SI 2020/1057 have been replaced by the local alert-level regulations. However, some amendments continue to apply, such as those that insert a definition for “indoors”. It has been necessary to maintain these regulations to ensure that the requirements on business, as provided under the obligations of undertakings regulation, continue to support the Covid-19 response.

I also want to take this opportunity to say a word about the 10 pm curfew. SAGE has highlighted that alcohol consumption may increase the risk of non-compliance with social distancing, and that hospitality settings are therefore associated with increased transmission. Given my 10 years’ experience at the front line of the late-night entertainment industry, to me this feels like a statement of common sense.

This epidemic is unprecedented. It is not possible to run randomised trials or controlled experiments, so we rely on our recent experience for the science. The views of our analysts are clear. In a Centers for Disease Control study of symptomatic patients from 11 US healthcare facilities in July 2020, adults with confirmed Covid-19 were approximately twice as likely as control participants to have reported dining at a restaurant in the 14 days before becoming symptomatic. Public Health England data shows that, between 3 August and 27 September, at least 148 outbreaks occurred in restaurant and food outlets. The PHE surveillance from 21 September to 27 September showed that 13% of those testing positive had eaten out around the time of their likely infection. Police data on street anti-social behaviour suggests that 10 pm is an inflection period in the night. Of course, we have the example of the Belgian authorities in Antwerp.

The prevalence of the disease in the younger demographic is a further clue to how the virus operates. Our initial experience suggests that the 10 pm curfew has struck the right balance, allowing businesses to trade for the majority of the evening while reducing the risk of compliance with social distancing measures breaking down. It has sent a signal to people, particularly young people, that socialising in a way that breaks social distancing is a sure way to transmit the disease. Engagement with local authorities is, and will continue to be, a key part of this and other response mechanisms.

We are not alone in our decision to ask pubs, restaurants and cafés to close early. Denmark, which had taken a more relaxed approach up to this point, is now asking hospitality settings to close at 10 pm. Urban areas in Spain and Germany have a curfew at 11 pm. Across Italy, there is a midnight curfew for all hospitality settings and a 9 pm curfew for those that do not offer table service. Nine cities in France, including Paris, have a curfew of 9 pm. In other countries, a curfew has been placed on other commercial and retail businesses. In Belgium and the Netherlands, there is an 8 pm curfew on the sale of alcohol. We are also seeing countries or areas that are experiencing steep rises in coronavirus cases go a step further in closing hospitality businesses altogether, allowing only takeaway services and outdoor dining. This is true for Belgium, France, Catalonia in Spain, the Netherlands and, most recently, the Republic of Ireland.

I am grateful for noble Lords’ contributions to these debates and continued patience and scrutiny. I take this opportunity to thank in particular the Joint Committee on Statutory Instruments for its reporting on both SIs, acknowledging that there were drafting errors in SI 2020/1029 and the Speaker’s letter being late for SI 2020/1059. We aim to meet our obligations to Parliament, the public and the statute book in making these regulations.

I have heard the numerous concerns from noble Lords. I commend the efforts of the usual channels to programme the business of the Chamber. I believe that these regulations are proportionate and necessary to protect the public from the spread of coronavirus. I beg to move.

Amendment to the Motion

Moved by

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I start by saying a massive hurrah to my noble friend Lady Fox of Buckley. I thank her for a rousing maiden speech, literally the best maiden speech that I have ever heard. She made a very clear case against cancel culture. She has identified herself as a free spirit, something that this Chamber values enormously, and has staked her claim as a champion for the transition from the EU. I know she joins many good friends in that cause here in the House.

I completely and utterly endorse the strong and heartfelt opinions expressed by the noble Lord, Lord Hunt, the noble Baroness, Lady Barker, and my noble friends Lady Altmann and Lady Neville-Rolfe on the hospitality industry. I have been part of the hospitality industry for a lot of my career. I care about it greatly and the sight of it ailing distresses me. I know those people who depend on casual labour from the hospitality industry to pay the bills; I have been one of them. I have no doubt about the profound impact at every level of society, from those who are poorly paid to those who own the businesses, of the restrictions that put those businesses under massive pressure—for some, maybe even terminal pressure. It would be completely inhuman of me not to address the economic and psychological distress of the result of that. I completely endorse their concerns on that matter.

However, I have to challenge some of the assumptions that seem to be in the ether. I have clear, positive evidence for the impact of Covid in late-night drinking. I wonder: what is the alternative, the counterfactual, that is being suggested in this debate? Is anyone really suggesting that late-night drinking is in some way conducive to social distancing? If so, they have very different memories from mine of times in the pub. Is anyone suggesting that late-night drinking somehow enhances the rule of six and brings discipline and a strict regime to people’s social lives in the pub after 10 pm? Is anyone suggesting that pubs somehow get cleaner after 10 pm, with the virus somehow evaporating like Cinderella at that time, instead of actually getting dirtier and more contagious? Is anyone really suggesting that post-pub socialising somehow reduces, the more you drink and the later it gets? None of those things was my experience; nor is it the experience of those who have put these regulations together.

My noble friend Lady Altmann is quite right to ask for an impact assessment. I guide her towards PHE, which has published a really clear assessment on the direct and indirect impacts of Covid-19, written by the ONS, the Department of Health and other government people, and approved by SAGE. It is important reading. It spells out in clear terms the impact on mortality, on the economy and on secondary health outcomes, and I highly recommend it.

I shall address some of the many worthy and valuable questions asked in this debate. The noble Lord, Lord Adonis, asked, slightly off-topic but very importantly, about schools. He is right: it a source of concern that there is a balance to be struck between the discipline and requirements of keeping infection out of schools and the importance of keeping those schools going full-time. As a father, I can say that two of my children are out of school at the moment and there is a huge amount of pressure on the disciplines. I reassure the noble Lord that we are working intensively with teachers, schools, councils and the Chief Medical Officer’s office to put together guidelines that can accommodate these very difficult situations.

I applaud my noble friend Lord Blencathra’s commitment to consent but I remind him that we have hardened the legal framework; in fact, we were here discussing that a few hours ago. However, I utterly reject his characterisation of the NHS. Instead, I pay tribute to the doctors, the nurses and indeed the bureaucrats who keep the show on the road under extremely difficult circumstances. I warn everyone that any virus as vicious as Covid will be a huge challenge to any health system. I am extremely proud of the way that the NHS has stood tall in the face of this storm.

My noble friend Lady Stroud lifted the debate, characteristically, with extremely wise words on prosperity, trust and personal responsibility. These are very much the values that we seek to apply in our response to Covid. However, I remind her that we need to balance personal freedom with the public health imperatives, of which there are two in particular: first, my health affects your health; and, secondly, we can beat this virus only by acting together. It is by balancing those two imperatives—personal freedom and public health—that we go about our business.

I was extremely surprised by my noble friend Lord Balfe’s comments, coming from someone who is normally such a sensible source of grounded wisdom. He somehow made the case for the thinking classes and the commentariat as if they should be running government policy—God forbid. In fact, I remind him that, as the noble Lord put it, these restrictions are working, they have had an impact on the spread of the disease, they are massively supported by the public and, as he knows, the alternative is a meltdown of our health service, and potentially hundreds of thousands of deaths.

My noble friend Lord Bourne is right to raise the difference between weddings and funerals. I can explain it briefly but I am happy to write to him in more detail: weddings are considered to be relatively voluntary but funerals are completely involuntary. That is why we allow a larger number of people at a funeral than at a wedding.

I would like to end on a note of optimism. My noble friend Lord Moynihan asked whether we were still focused on the actual care of people. I reassure him and the Chamber that we have made massive strides in the development of therapeutics to help us treat those with Covid. We understand more and more about the impact of long Covid, which is a terrible threat, and we understand better and better the ways in which we can diagnose this awful disease.

My noble friend Lord Bourne and the noble Baroness, Lady Jolly, both mentioned Taiwan. I share their respect and admiration for the way in which that small democratic island has gone about its public health challenge. There is a lot to learn for all of us.

I reassure the noble Lord, Lord Bilimoria, who has become an even greater evangelist for mass testing surveillance than me, that we are making massive strides. I pay tribute to the innovators around the world, but particularly the British innovators, who are bringing us incredible new testing technologies, and we are applying them at speed.

Finally, I ask the noble Baroness, Lady Jolly, to weigh heavily the tremendous commitment that we have to working with councils. In response to the noble Baroness, Lady Thornton, I do not think that I ever said that the discussions were easy or wonderful; I said that they were energetic. She has a point—these relationships are difficult and, as we speak, just how difficult some of them are is being played out. However, that does not mean that we do not care or that we have not tried. In fact, I hope that we can build on this engagement to create not only a stronger response to Covid but, ultimately, a stronger democracy. In that spirit, I ask the noble Baroness to withdraw her amendment.

Health Protection (Coronavirus, Restrictions) (North of England, North East and North West of England and Obligations of Undertakings (England) etc.) (Amendment) Regulations 2020

Lord Bethell Excerpts

Tuesday 20th October 2020 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 30 September be approved.

Relevant documents: 27th Report from the Joint Committee on Statutory Instruments (special attention drawn to the instrument) and 29th Report from the Secondary Legislation Scrutiny Committee

Motion agreed.

Covid-19

Lord Bethell Excerpts

Tuesday 20th October 2020 Lords Chamber

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

My Lords, I am grateful for the questions from the noble Baroness, Lady Thornton. If the noble Baroness, Lady Jolly, returns, I shall be happy to answer her questions, too.

The noble Baroness, Lady Thornton, asked a lot about the testing programme. Let me reassure her with some statistics about last week’s processes. Some 1,892,000 test were done in the week from 1 to 7 October—I repeat, 1,892,000 tests. That is a colossal number, and the vast majority of them were done promptly, accurately, and to the satisfaction of those involved. Of those, 89,874 results were positive, which is a substantial increase of 64% compared to the previous week. That is 89,874 people who would not have had a test six months ago, because we simply did not have the capacity, the knowhow or the systems to do that.

The number of people transferred to the test and trace programme since the beginning of August has increased by 10 times; 67,511 were reached, of whom 57,000 provided details of one or more close contacts. In other words, 67,511 people were taken out of the chain of transmission and asked to isolate, were provided with a financial supplement to care for them and were phoned—sometimes many times, it would appear but, generally, once or twice a week—in a pastoral call to ensure that they had access to local authority, charity and financial support. Of those non-complex cases, 55.9% were reached within 24 hours. That is not good enough, and we need to work on it more, but 55.9% is enough to make a serious impact on the progress of this virus. Without the test and trace programme, we really would not be match fit to combat this virus at all.

The story that the noble Baroness told of her friends was distressing. Anybody who has had the virus will know that it is a miserable affair. For the entire family to have had it is very sad, and my feelings are sincere when I say that I am sorry to hear about her friends who have had coronavirus. But the guidance is relatively straightforward. You are to isolate for 14 days from the original infection. That would have been the advice that they had on the telephone and, if their app said otherwise, the telephone supersedes anything that the technology might have told them.

On getting tests at all, I acknowledge that the general public are not at the top of the priority list right now. The top priority is to protect clinicians and NHS workers, as well as those in hospital care who have the threat of nosocomial infection. Secondly comes social care—protecting those who are vulnerable and live either in residential or domiciliary care. Those people are at the top of the list. We are building our capacity dramatically; we are on course to hit our ambition of 500,000 tests per day by the end of October, and many more beyond that.

The tests that the noble Baroness, Lady Thornton, described are incredibly impressive. The saliva testing is much easier to use, and the LAMP testing is phenomenally accurate. The capacity for those LAMP tests to be rolled out across social care and hospitals is enormous, and we are investing considerably in that.

The noble Baroness, Lady Thornton, also asked about Manchester, and there the situation is distressing. I cannot hide the fact that the increase in prevalence in Manchester is a source of enormous sadness, but I reassure her that the extra measures that have been taken there have been accompanied by the offer of extremely generous financial measures.

Those financial measures have been accepted by Lancashire and by Blackpool—but not, it seems so far, by Manchester. We hope very much indeed that Manchester will remain at the table. The negotiations being undertaken by the Government are generous and open hearted. We have already made available £465 million to help local authorities implement and enforce restrictions. Greater Manchester will definitely receive £22 million of this, and we will continue to work with the Greater Manchester councils to ensure that testing and local contact tracing are allocated in the right way. We will continue with those negotiations. The negotiations with Manchester were entirely proportionate to the support that we have given to the Liverpool City Region and to Lancashire, and it is a source of enormous regret that the mayor decided to reject it.

[The Deputy Speaker (Baroness Henig) (Lab)]

We now come to the 30 minutes allocated for Back-Bench questions. I ask that questions and answers be brief so that I can call the maximum number of speakers.

[Lord Lansley (Con)]

My Lords, the figures today for the number of cases and deaths are deeply worrying. It is a 20% increase in the week in the number of cases and, of course, the number of cases that we have seen in recent weeks is now tragically leading to a much-increased number of deaths, so there are no grounds for complacency. However, as I think we all understand, this is a marathon, not a sprint, and there is an inevitable tension in the question of how far businesses can be shut down on a permanent basis—and we want to avoid that.

I put it to the Minister that to support businesses that are Covid-secure and keeping open, we need compensating measures to try to limit the transmission in social circumstances. Would the Government consider extending the advice across England that, when indoors, people should mix only in their own household and social bubble, and that the rule of six, while continuing to apply, is not sufficient indoors? We need to limit the mixing of households indoors.

[Lord Bethell (Con)]

My Lords, my noble friend’s observation is entirely right. In Manchester alone there have been more coronavirus infections already in October than in July, August and September combined. The average daily hospital admissions in Greater Manchester are now higher than they were on 26 March, and there are now more Covid-19 patients in Greater Manchester hospitals than in the whole of the south-west and the south-east combined. These are illustrative of one region but it is a story that has already played out in others, and we naturally fear that it will play out in others in the future.

My noble friend’s advice on the mixing of households is very perceptive. One thing with that we cannot do anything about is the kind of infection that the noble Baroness, Lady Thornton, described among her friends, where it spreads within a household. That is something that no household can reasonably fight against. However, stopping the spread of disease between different households is something that we can lean into. It requires an enormous amount of social distancing and a return to the kind of lockdown measures that we had at the beginning of this year. That is something that we are extremely anxious to avoid because it has enormous social impact, it is disruptive to our way of life, and it has an economic impact because it has implications on social distancing and on some businesses. Still, my noble friend is entirely right that that is exactly the kind of area that we will need to look at if we are to contain the spread of the virus.

[The Lord Bishop of London]

My Lords, from my background as a former Chief Nursing Officer, I am aware of the difficult decisions that Her Majesty’s Government are required to make, as well as of the importance at this specific time of good public health action. However, I have heard the concerns expressed by my colleagues in the north-east and the north-west of England, including some of my right reverend friends in your Lordships’ House: Covid-19 is disproportionately affecting the vulnerable and, unfortunately, so are the restrictions. There are significant concerns about their compliance with regulations that they do not feel are fair. The Government have frequently made assertions about public health behaviour and science without publishing the evidence or properly engaging with people in the communities affected. The interventions may well be right but the implementation seems to be failing. The Government must genuinely engage with, listen to and learn from people affected at a local level. Without such local buy-in, public health actions will not happen.

There is also some concern that the restrictions are impacting on those least able to manage the health and economic impact. There are concerns that movement into tier 3 will continue to exacerbate matters such as child poverty, deprivation, economic and health inequalities and poor mental health. If the perception is allowed to grow that certain sections of the economy or society can be allowed to bear the substantive weight of fresh regulations without levels of financial support, the consensus will not hold. Will the Minister reassure your Lordships’ House that, as areas move to tier 3, local voices will be listened to and everything will be done to ensure that the risk to the most vulnerable is minimised?

As I have already said in your Lordships’ House, the local public health nurse can inform top-down rules with local experience. What is being done to ensure that when the ring-fencing of funding that was passed to local government for public health comes to an end at the end of this financial year, it does not lead to further disinvestment in public health?

Lastly, faith communities, like public health nurses, are part of local populations and areas, and should be used more as experts to help leverage insights that they gain on the ground to support the public health action and interventions needed. I again encourage the Government not to neglect the whole-system approach to public health, as we work together on the challenge of Covid-19.

[Lord Bethell (Con)]

The right reverend Prelate puts it extremely well. We completely recognise that not only does the virus attack the most vulnerable, but those who are least fortunate bear the huge brunt of the lockdown and the measures needed to crack down on the virus. In these matters, I emphasise that it is worth stepping back and reminding ourselves that the Government are not the source of the problem; the virus is. All the Government can do is take measures to save lives, protect our healthcare service and keep our schools open. In that way, it is not right to demonise central government for taking measures.

Central government can take measures to help protect the vulnerable, and I acknowledge the right reverend Prelate’s point on this. I reassure her that we have put in place the Job Support Scheme to ensure that those affected by business closure are still paid; we have made £465 million available to help local authorities implement and enforce restrictions; we have provided £1 billion of extra funding to local authorities across the country; and we are committed to working with local authorities to allocate testing and tracing locally.

On the message the Government deliver, I recognise the phenomenon described by the right reverend Prelate, but I reassure her that there is no intent by government to make an association between poor behaviours and results. The data is there. We have published every piece of data we can and, to an extent, it does not lie. It is an uncomfortable truth, but some communities have consistently higher prevalence and infection rates. There is some responsibility on those communities to address the causes of that. It is an intent shared by government, local authorities, communities and individuals. There is no avoiding the fact that you cannot pin responsibility on any one of those four pillars.

Lastly, the right reverend Prelate is entirely right that faith communities pay an important role. I pay testimony to those faith communities in cities such as Leicester and Bolton, which have worked with us to great effect. We continue to put our relations with faith communities at the centre of our outreach to communities.

[Baroness Andrews (Lab) [V]]

My Lords, is the Minister aware that, today, a highly respected member of SAGE, Professor Stephen Reicher, said that the three-tier system is

“the worst of all worlds … where there is no sense of clarity. There is a growing sense of inequity and resistance”?

Wales has decided to go for a circuit break, with the situation deteriorating, and a poll suggests that public opinion is very much moving towards recognising that this is necessary and will support it. What evidence can the Minister provide to show Professor Reicher that he is wrong?

--- Later in debate ---

[Lord Bethell (Con)]

The noble Baroness makes her point well, but I will defend the three-tier system. It is an important mechanism to avoid a national lock- down, which is our objective. It was designed in close collaboration with local authorities and stakeholder groups. It has proved effective in a number of areas, and there is evidence of infection rates coming down where local lockdowns have been effective. But I completely agree with her analysis of public opinion. There is a growing sentiment that decisive action may be necessary, and an enormous amount of support, despite what one reads in the newspapers, for decisive action by the Government to restrict the spread of this virus.

[Lord Rooker (Lab) [V]]

I will change the subject. Early in the Statement yesterday, the Secretary of State referred to the shortening of the wait for cancer treatment since the long waits in July. I support the Secretary of State in thanking all the cancer teams working so hard, and indeed single out the staff of Hereford County Hospital in charge of my treatment, which started in Christmas week last year. Can the Minister confirm that the two-week cancer diagnosis plan is still functioning, and will he do more to encourage people to attend their GP, as I did, not guessing what was wrong? They do not have to be uncertain or have a suspicion, but if they know something might be wrong, the GP and the specialist will find it out. People need to be encouraged to do that and not be put off by the pressures on the NHS from the virus.

[Lord Bethell (Con)]

My Lords, I am enormously pleased to hear that the noble Lord’s cancer treatment has progressed so well. Like him, I pay tribute to those at the Hereford County Hospital who participated in his treatment, and in fact to all those who have maintained an incredibly high level of cancer treatments through the difficulties of the pandemic. Broadly, cancer treatments were maintained at around 85% of their normal practice during the summer months, and the restart has come on a long way. In July 2020, 87.8% of patients saw a cancer specialist within two weeks following a referral from their GP, and 94.5% of patients received treatment within 31 days of a decision to treat. However, I completely agree with the noble Lord’s analysis: more could be done. That is why we are backing the Help Us, Help You campaign, which is a very high-profile marketing campaign, to try to drive up attendance rates and ensure that no one is put off by fear of hospitals or GP surgeries when they have a tell-tale sign, and that they go and get the referral that they need.

[Baroness Pidding (Con) [V]]

My Lords, we have clear evidence that obesity is a real hazard with regard to Covid-19. Tackling obesity and promoting the benefits of exercise, both for our physical and mental well-being, are quite rightly priorities of this Government, both now during this pandemic and beyond. Does my noble friend the Minister agree that we need to do all we can to ensure that gyms remain open as long as they can operate in a Covid-safe environment? Can he also confirm my understanding that we have two regions that are both currently in tier 3 with differing restrictions: Merseyside where gyms are closed, and Lancashire where gyms are open? Surely we need clarity of message.

--- Later in debate ---

[Lord Bethell (Con)]

My noble friend illustrates the complexity of trying to work with local authorities and the impact of giving local authorities the discretion to make decisions on their own. In this area, in tier 3, we gave discretion to local authorities on their gyms. Merseyside decided to close its gyms and Lancashire did not. It is entirely appropriate for them to make their own assessment. I confess to feeling a real and genuine dilemma when it comes to gyms. My noble friend is entirely right that activity is important, particularly at a time of lockdown. However, medical advice on hygiene is that the spray from exertion and sweaty bodies is very difficult to contain, even in a well-meaning and well-managed gym. That is why we have given local authorities that choice and why we keep the matter under review.

[Lord Dubs (Lab) [V]]

My Lords, I have two brief questions. Somebody I know received the following message on their mobile phone:

“Possible COVID-19 exposure. Verifying exposure info. The app has accessed the date, duration and signal strength of this exposure.”


Can the Minister say what this means? Is the recipient supposed to do anything about it or is this some maverick message? My second question is on a different point. Does the Minister agree that there are people in this country who are too apprehensive about the possible quarantine to go abroad and so have to quarantine on their return to this country? Could we not adopt the system, which certainly seems to be working in Germany, that we offer testing for people arriving from areas where they are liable to be quarantined, possibly testing them two or three days later? That means they would not have to be in quarantine for two weeks and risk losing their job, and so on. Could we not adopt that simple expedient?

[Lord Bethell (Con)]

I reassure the noble Lord that his friend’s notification came from a new feature of Apple phones called “Exposure Notifications Express”. This is something that we have worked hard to incorporate in the existing app. I slightly suspect that, if she has a new version of the NHS app, she will not receive these notifications any more. We are grateful to Apple for enabling its phones to work in developing countries, but there has been some turbulence with our own app, which we think we have resolved.

On quarantines, I say that, as a follower of these debates, the noble Lord will know that the CMO’s view is that testing on arrival will capture only 7% of infections, and it is very difficult to apply quarantines to get people to commit to staying longer. However, we are committed to running pilots to try to open the kinds of schemes that he describes, and I would be happy to report back on their development.

[Baroness Wheatcroft (Non-Afl) [V]]

My Lords, at the beginning of this debate, the Minister gave a very spirited defence of the test and trace system. This morning, my daughter and her 15 month-old daughter were tested, and it was very efficiently done, but they were told that they should expect results in two to three days’ time. The Minister mentioned 24 hours; what timetable are the Government trying to operate on for test and trace because, clearly, if there are two days that are fallow, an awful lot of people risk being infected?

I will also address the issue of gyms. The noble Baroness, Lady Thornton, talked about the lack of clarity at the beginning of this debate. If people are to stick to the rules, they need clarity. I do not understand why gyms are open at all, quite honestly. It seems to me—as the Minister indicated—that they are potential hotbeds for coronavirus. However, we are told that discretion is given to local authorities to decide what they do and do not allow. I recall that Manchester was absolutely determined that it would like to stop alcohol sales at the same time that, if not sooner than, pubs were forced to close, but it was not given discretion over that. I would be grateful if the Minister could explain when local authorities do and do not have discretion.

I also wonder whether the Minister could tell the House the position on travel to work. Office workers are told to work from home if it is possible for them not to work from the office, but there does not seem to be a ruling that says, “Do not go to work in an office unless you absolutely have to”. What counts as essential? What instructions are the Government giving to civil servants about whether they should travel to work? We are told that gatherings that are “reasonably necessary” can take place in office environments with no limit on the numbers involved. In the circumstances, that seems crazy. If the Minister could clarify the position, I would be grateful.

[Lord Bethell (Con)]

I reassure the noble Baroness that 24 hours is our objective, and it is clear that a 24-hour target is right. Having swift turnaround is conducive to effectiveness, and that is what we are trying to do. There has been a very large increase in demand in the last 11 weeks, which has put pressure on our operations and pushed back some of our turnaround times. We are working extremely hard to address that; new capacity is coming on-stream all the time, and we are hopeful that that can be turned around very quickly.

The noble Baroness is entirely right to raise her point on clarity, which is very similar to those raised by others, including the right reverend Prelate. There is a really important balance that we have to get right here because to have communal buy-in to our measures, we need to somehow mobilise leaders that people trust, from their faith community, their local community or other leadership groups that they subscribe to.

However, to give people a role in the decision-making about what measures are to take place in one area or another, there will be an uneven application of regulations—what happens in one place will not be the same in another. We have made a commitment to a partnership between national and local government, and we are trying to manage that complex partnership at the moment. As noble Lords know from the discussions in the other place and our conversations with Manchester, this is an extremely bumpy affair and it does not always work out well.

However, we are committed to doing this precisely for the reasons the noble Baroness described: to have buy-in, we need to mobilise all the country and all the people who are respected by those who adhere to the rules. That is why we take the approach we do. It means that gyms will be open in Lancashire but not in Merseyside. It is argued that this is a complexity that the British public can handle. It also takes us into very public conversations about funding, the allocation of resources and the establishment of new testing facilities. We believe it is worth the administrative and political effort to try to do that. There are also delays to the implementation of some of the restrictions. The British public will form their own judgment on their politicians and whether that is worth their while. These are the prices and friction costs to the local/national partnership that we are committed to, which has been advocated on the Benches of this Chamber for many months.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, the noble Lord, Lord Lansley, referred to the risk of mixing indoors. From the housing department, the noble Lord, Lord Greenhalgh, today kindly answered a Written Question from me about ventilation standards in building regulations in the light of Covid-19. It referred to the most recent SAGE paper on aerosol transmission, dated 22 July. The science on aerosol transmission has moved on a great deal since then. The noble Lord indicated that a new paper is being prepared by the SAGE Environmental and Modelling group. I note that German schools, for example, have strict conditions about opening windows regularly, even in the coldest conditions. Is the Minister confident that the current strength of advice on levels of ventilation, particularly to businesses where people are mixing, either retail premises, offices, or gyms, as we have been discussing, and to schools, is adequate?

[Lord Bethell (Con)]

The noble Baroness is right to raise questions about the way in which the disease is transmitted. We have put a huge amount of effort into studying it. I pay tribute to the epidemiologists who have crafted sophisticated models and have sought to test them in practical ways in order to establish, for good, the really important questions of how one person’s conversation, breathing and spoken word might transmit the disease to another person either through the air or on surfaces. Understanding that is absolutely essential in order for us to put in place the right kinds of Covid safety measures. However, at this stage it is an imprecise science. For instance, there is some evidence that transmission from hygiene and surfaces can play a very important role, perhaps meaning that we have to invest more thought and commitment in cleaning measures. The guidelines we have for workplace and school testing reflect the very best provable standards according to scientific evidence. We continue to invest in these important epidemiological insights, and I welcome very much the contribution of the scientists on SAGE and all those who continue to try to gain a better understanding of this issue.

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

My Lords, in the first Statement that we are debating, the Secretary of State spoke about the strategy being to suppress the virus and support the economy and the NHS. He did not specifically mention the vaccine programme, although clearly it is an important part of our approach. Although the Government have secured early access to, I think, over 300 million doses, there will not be enough for the entire population to receive them immediately. The Joint Committee on Vaccination and Immunisation has published interim advice on a prioritisation programme. Will the Government follow that advice, and can the Minister say more about what work is being undertaken to encourage a high uptake?

[Lord Bethell (Con)]

I thank the noble Lord for his interest. The JCVI is, as he described, the agency responsible for giving advice on the prioritisation plan. Our policy is to follow that advice, and I pay tribute to those on the panel for the hard work they are putting into that. The interim advice is extremely thoughtful and follows the best values and standards of this country. We are putting a lot of work into trying to raise adoption rates of the vaccine. We face a challenge from those who would like to query the science or have some form of national or commercial vested interest in undermining confidence in the vaccine. We are putting a lot of work into mitigating that risk. That is not work that I would like to discuss at the Dispatch Box but I would be very glad to share some of it privately at a later date.

House adjourned at 8.11 pm.

Medicines and Medical Devices Bill

Lord Bethell Excerpts

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

It is bad enough that this is a skeleton Bill. The root of the problem is the Government’s desire to take powers to make policy before they have decided what that policy is. We should make sure that the powers in the Bill to act without proper parliamentary scrutiny expire as soon as enough time has passed to allow them to be replaced by primary legislation, subject to proper parliamentary scrutiny. I hope the Minister can agree. If not, I expect us to return to the issue on Report.

[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.

--- Later in debate ---

[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.

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Moved by

[Lord Bethell]

2: Page 1, line 6, at end insert—
“(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.

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[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.

[Lord Bethell (Con)]

I would be happy to conduct that follow-up.

Amendment 2 agreed.

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[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.

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[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.

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Moved by

[Lord Bethell]

7: Page 1, line 7, leave out “making regulations under subsection (1)” and insert “considering whether they would”
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.