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

Lord Bethell Excerpts

Tuesday 20th July 2021 Lords Chamber

Moved by

[Lord Bethell]

That the draft Regulations laid before the House on 22 June be approved.

Relevant documents: 8th and 10th Reports from the Secondary Legislation Scrutiny Committee (special attention drawn to the instrument)

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

My Lords, more than ever, the social care workforce demonstrates unwavering compassion and dedication for our elderly and most vulnerable. We are proud of and immensely grateful to them. I pay huge tribute to their tireless work during this pandemic to protect people who are most vulnerable to Covid-19, including their incredible efforts to support the vaccination rollout across the sector, to bring in infection controls and to provide pastoral care during this most heartbreakingly lonely episode.

To date, 1.2 million social care workers in England have been vaccinated. This is an incredible achievement and an important step for staff to protect themselves, their loved ones and the people they care for from becoming seriously ill or potentially dying from Covid-19. However, there is a tipping point here. It is a tipping point of safety when it comes to care homes, where many of our most vulnerable priority-list loved ones live. We are not quite there yet.

SAGE recommends that 80% of staff and 90% of residents should have received their first dose of the vaccine to provide a minimum level of protection against coronavirus outbreaks. We have all been witness to the incredible pace at which vaccination programmes have been rolled out. I am delighted to report to the House that 96% of those living in older-age care homes have received their first dose and 93% their second dose. Meanwhile, 93% of those living in younger-age care homes have received their first dose and 88% their second dose.

In many places, take-up among care home staff is also impressive. Some 87% of those working in older-age care homes have had their first dose and 76% their second dose. This compares with 83% and 73% respectively for staff working in younger-age care homes. However, there is also significant variation at a regional and a local level. Only 65% of older care homes in England are meeting SAGE’s stipulated safety tipping point in the latest published data. This drops to an even more worrying 44% in the London area.

As a result, despite very high levels of vaccination, testing, PPE and other infection control measures, we are still seeing outbreaks in care homes, where residents are incredibly vulnerable to the serious effects of this terrible disease. Since January this year, care homes have tested staff more than 21 million times and made proper use of 1.2 billion items of PPE. Yet nearly 14,000 care home residents have died because of the virus this year alone.

This winter will be challenging and, in the face of rising case rates across the country, we need to make sure that we have done everything we can to prepare and to minimise the risks for residents in care homes and the incredible staff who care for them.

This is the context. It makes this legislation critical. By November this year—and subject to the usual parliamentary approval and, we hope, a helpful and practical 16-week grace period—anyone entering a CQC-registered care home in England must be vaccinated, unless a valid exemption applies. This will apply to all care home workers, agency staff and volunteers. Visiting healthcare workers, tradespeople, hairdressers and CQC inspectors will also be obliged to follow the new requirement.

We have considered this policy incredibly carefully, consulting thoroughly and extensively to get this right both for residents who are so vulnerable to Covid and the staff who go above and beyond in caring for them every day. The policy will therefore apply to all people over 18 who work inside a care home unless they have a medical reason not to be vaccinated.

Further limited exceptions have been made to ensure that this works on the ground. Emergency services, people providing emergency assistance and those undertaking urgent maintenance work can all enter a care home without needing to show that they are vaccinated. Visiting family and friends are also exempt, given the significant well-being benefits such contact provides. While we would always encourage all these people to take up an offer of a vaccine, we have acted on the advice from SAGE that a balance must be struck.

Before I turn to our assessment of the impact this may have on the workforce, I acknowledge the vital role the Secondary Legislation Scrutiny Committee has played in its calls for further details outlining the Government’s current analysis of the expected impact of the draft regulations. Following its eighth report, we made an impact statement available to this effect, and we note the further points raised in its 10th report yesterday. I can also confirm to the House that we will be publishing a full impact assessment as soon as possible.

After everything care home staff have done in the pandemic, we owe them the greatest consideration and respect. We understand that providers and their staff need time to prepare for these changes, which is why the 16-week grace period immediately following the enactment of regulations will allow staff who have not been vaccinated to make arrangements to have both doses. Unfortunately, we recognise that there will be some staff who will choose to leave rather than be vaccinated. Our central analysis estimates that around 7% of current staff may not meet the requirement by the end of the 16-week grace period. This equates to 40,000, out of a workforce of 570,000, who may need recruiting to replace staff who do not meet the requirement.

However, this estimate is very uncertain. We just do not know yet exactly how staff will respond to the requirement, not least because staff turnover in this sector is around a third each year. I am grateful to Professor Martin Green of Care England for talking me through these concerns. Of course, we do not want to lose valuable care home staff who have made an enormous sacrifice over the last year and a half, and we will continue our efforts to drive uptake across the sector. We owe it to ourselves and to their commitment to try our hardest. However, our overriding priority has to be the safety and well-being of the people they care for.

Before closing, I pay a final tribute to all care home staff, past, present and future, who have played a vital role in our nation’s recovery from the pandemic. We did not take lightly the decision to introduce this legislation. However, the risks that this winter will undoubtedly pose to the most vulnerable in our society make clear the choice that we must make: to do everything in our power to protect them. With that sentiment in mind, I commend these regulations to the House. I beg to move.

Amendment to the Motion

Moved by

--- Later in debate ---

[Lord Bethell (Con) [V]]

My Lords, I thank noble Lords for their considered questions and huge interest in the instrument laid before us today. Tragically, there have been more than 30,000 deaths recorded among care home residents during this pandemic. We have a duty to do all we can to prevent further suffering. Testing,PPE and infection prevention can go only so far in the mitigation of risk. Ensuring very high levels of vaccination for people living and working in care homes is an essential public health intervention for a serious vaccine-preventable disease.

To answer my noble friend Lord Lansley, the residential care workers covered by these regulations are handling the most vulnerable and elderly in priority list 1, which is why we started with them. Forthcoming consultations will address those who work with priority lists 2 to 4 and, in response to the noble Baroness, Lady Brinton, we may ultimately consult on extending further into the rest of the health and social care workforce. My noble friend Lord Lansley asked about resources. Our focus has been on ensuring that the social care sector has the resources it needs to respond to the pandemic. On 27 June, we announced a further £251 million of adult social care Covid-19 support, through an extension of the infection control and testing fund.

I say to my noble friend Lady Foster, who spoke with such passion on individual choice, that it is worth bearing in mind that many people are not afforded much, if any, choice in who cares for them. We have heard from people with lived experience of care. They want to know that the person who cares for them is vaccinated. I am not instinctively a supporter of mandatory measures. I note my noble friend’s philosophical points on this with great interest. I am even less keen to impose obligations on those people just at the time when the rest of society is opening up around them. But the noble Baroness, Lady Tyler, put it very well. She made a strong case, with moving personal testimony, that it is right that we protect the most vulnerable, even if it would take us further than we would normally go. We simply cannot be in a position where those most in need of care and the highest level of protection from the threat of Covid face a lottery of risk depending on the level of vaccine uptake by those working in their care. My noble friend Lord Cormack has spoken on this on several occasions extremely movingly.

It is not our intention to compel anyone to take the vaccine against their will. We can, and should, make it an essential criterion for working in care homes—to make it an explicit duty of care, providing peace of mind to colleagues, residents and all who visit. Barchester, a large care home provider with over 16,000 staff, already requires staff to be vaccinated. The evidence there gives us real cause to be hopeful, showing that, having taken the time and effort to engage with employees, understand their concerns and encourage them to take up the vaccine, only 0.5% of staff left the workforce. I reassure the noble Baroness, Lady Wheeler, that there have been huge efforts to drive vaccination take-up among care home staff in recent months already. In response to the noble Baroness, Lady Brinton, and others who have spoken on this point, I would welcome the opportunity to update noble Lords on these efforts, in detail, at a suitable briefing.

We have heard the arguments made by the noble Baroness, Lady Tyler, that social care teams need support. That is exactly why vaccination teams have visited care homes to offer vaccinations to both residents and staff, with actions at the national, regional and local level to improve access and address concerns. To answer the concerns of the noble Baroness, Lady Wheeler, on guidance, I reassure the House that we recognise the need to introduce these changes with the utmost care and sensitivity. To the noble Baroness, Lady Brinton, we are working with representatives from the sector to produce detailed operational guidance to support implementation. The noble Baroness, Lady Tyler, is right that the implementation is complex, so we will also be working with Skills for Care, the charity focused on workforce development, to ensure that guidance and best practice are available to support providers and local authorities. I say to the noble Lord, Lord Campbell-Savours, that the wearing of masks in a care home setting is properly governed by regulations. I reassure him that the guidelines are rigorously enforced.

I will address the heartfelt, tough and, if I may say, challenging remarks of noble Lords on the impact statement. I reassure noble Lords that this Minister, this department and this Government fully respect Parliament, and the scrutiny and challenge brought by Parliament and this House. We have published an impact statement. I say to the noble Lord, Lord Hunt, that there is no question of us trying to hide that. But it is very complex. I hope the House will appreciate that there is an enormous amount about this pandemic that is unprecedented. The noble Lord, Lord Hunt, put it well. We cannot be sure how staff will react to this unprecedented measure. That is what drives the financial model, but how do we know how many will leave the sector or take a lateral move to a non-sensitive role?

Much about the vaccine has confounded expectation. Who would have thought a year ago that the take up of the vaccine among the elderly would be in the mid-90% range, or that the take-up among the young would be incredibly encouraging? As I said, one major care home provider has already brought in such a measure and saw a drop-off of less than 1%. That is why the drafting of the impact assessment has been such a struggle. There is no question of hiding or of misleading the House. We are working with partners to generate the most credible calculations possible. We will publish the impact assessment as soon as possible and we are using this time to hammer out the best estimate we can.

To the concerns of the noble Baroness, Lady Wheeler, I say that it is right that we start with care homes, where residents and staff are the top priority, and we intend to consult further on the rest of health and social care. It is also right to acknowledge the important role of the Joint Committee on Statutory Instruments in considering the regulations. I acknowledge fulsomely the vital role of the Secondary Legislation Scrutiny Committee in scrutinising the legislation and holding the Government to account. We are particularly grateful to the committee for giving us the opportunity to explain the policy in further detail in an evidence session last week.

Covid-19: Aligning UK and Foreign Entry and Return Requirements

Lord Bethell Excerpts

Monday 19th July 2021 Lords Chamber

[Lord Blunkett (Lab) [V]]

I hope for the last time virtually, I beg leave to ask the Question standing in my name on the Order Paper and draw attention to my declaration on the register.

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

My Lords, the Government are working with a range of international partners to ensure a safe return to international travel while managing public health risks. We are taking a phased approach to amending requirements for passengers fully vaccinated through the UK programme and exploring plans to remove quarantine for non-UK residents arriving from amber countries from later this summer. The purpose of our inbound travel—[Inaudible]—while ensuring that our route out of the international travel restrictions is sustainable.

[Lord Blunkett (Lab) [V]]

My Lords, at home and abroad, freedom day is in danger of turning into confusion day. Surely people should not be punished in any way for wanting, for business or for pleasure, to leave and return to our country freely. Clarity, consistency and some sort of understanding of the impact on our foreign relations would surely not only help but save our aviation and travel industry. Would the Minister agree that discussion with our friends could have led to an understanding of the constitution of the French Fifth Republic and avoided the need to invent amber-plus, thereby enabling us to be able to treat the French as they would treat us, given that our infection levels are pretty much at amber-plus?

[Lord Bethell (Con) [V]]

My Lords, I completely agree with the noble Lord that we should be utterly committed to the route to sustainable, open borders. However, we cannot hide from the threat of infection from abroad. That infection comes from higher rates from abroad—the positivity rates of some countries have been in the high teens—but also the threat of variants of concern, particularly the vaccine-evading beta variant, which is highly prevalent in some countries, including, increasingly, France.

[Lord McConnell of Glenscorrodale (Lab)]

My Lords, the lack of co-ordination of regulations and announcements between the four Governments of the United Kingdom has been one of the worst examples of incompetence throughout these past 16 months. That is now particularly true in relation to international travel. Why is it impossible for these four Governments to agree one set of rules for people travelling in and out of the United Kingdom? What will the Government do to try to improve the situation, even if it cannot be resolved for the summer-?

[Lord Bethell (Con) [V]]

My Lords, I am not sure whether I agree with the premise of the question. I pay tribute to the collaborative spirit in which the four nations have worked together. I have regular meetings with my counterparties—in fact I have one this afternoon—in order to talk about exactly this sort of co-ordination. The answer to the noble Lord’s question is, in the framing of the question, that it is not in my or the Government’s gift to manage this on our own; we depend on collaboration in order to have co-ordination.

[Lord Scriven (LD)]

My Lords, the director-general of the International Air Transport Association has said that the Government now have

“no coherent policy on international travel.”

To prove him wrong, can the Minister state what data the Government are using to determine the positivity rate for the beta variant on mainland France, and what that data shows for the cases of the beta variant on mainland France?

[Lord Bethell (Con) [V]]

My Lords, the noble Lord’s question has behind it a genuine dilemma. The amount of genomic sequencing in countries around the world is limited. No other country has the degree of genomic sequencing that we have here in the UK, and we do not have perfect vision of what variants of concern are present in other countries, including even in France. We work very closely with Governments, including that of France, to have access to whatever data they have—but, to an extent, we are operating with imperfect data.

[Lord Bourne of Aberystwyth (Con) [V]]

My Lords, clearly, as international travel restrictions ease, co-ordination of travel rules will become imperative. In that regard, will the Minister impress on colleagues in government the good sense of Britain leading the way internationally in ensuring that vaccination records are carried in passports, to demonstrate the vaccine histories of those travelling? This will speed checks, make them secure and promote an international approach to vaccine-secure travel.

[Lord Bethell (Con) [V]]

My Lords, I entirely agree with my noble friend that co-ordination of vaccine certification is a massive priority. We are working extremely closely, particularly with our close friends in America and the EU, to have mutual recognition of certification. Whether that certification is tied to the passport is up to the tastes of local countries. In the UK we are putting certification in the NHS app, and it feels right that that should be contained and limited to health records rather than national identity documents. However, each country will have its own approach.

[The Earl of Clancarty (CB)]

My Lords, the Minister has previously promised to look at the cost of tests for travel purposes, yet the very wide variation in price from the 402 providers the Government list on their website—most of them well over £100 per test—is surely quite confusing for the public when, essentially, we are talking about the same product, even if the details of provision may vary, and critically so. Will the Government look at this, and indeed at the costs themselves?

[Lord Bethell (Con) [V]]

My Lords, I do look at the costs and have regular meetings with the team to look at this. I pay tribute both to officials and to the industry for standing up an enormous number of tests. I believe that, between 30 June and 7 July, 182,137 tests of people quarantining at home were registered and processed, and 18,946 by those who manage quarantine. That is an enormous number and pays tribute to the industry. A variety of costs reflects a variety of different services and in itself is not a problem—but we are driving the costs down and the industry is responding accordingly.

[Baroness Merron (Lab)]

My Lords, regrettably, we see the Covid border restrictions descend into further chaos with the last-minute U-turn on self-isolation requirements for fully vaccinated people returning from France. Once again, we see the travel industry and the British people paying the price. Will the Minister agree to publish the full data behind the traffic light system, and could he give his views on the stance of the World Health Organization, which has reaffirmed that it believes that proof of vaccination should not be required for international travel?

[Lord Bethell (Con) [V]]

My Lords, we are working with our partners to try to open up borders. There is a growing consensus that vaccination is an important component in opening up borders, and the Government generally support that. The virus itself chops and changes; we have to adapt in response to the growth of variants. I cannot promise that we will not act promptly and emphatically when the health of the nation is threatened.

[Lord Jones of Cheltenham (LD) [V]]

What advice can the Minister give to those who wish to travel to or from South Africa, or any other African countries which are popular with tourists?

[Lord Bethell (Con) [V]]

My Lords, as I mentioned earlier, we take the threat of the vaccine-evading beta variant extremely seriously indeed, therefore we are extremely cautious about travel to areas with a high prevalence of that variant.

[Lord Randall of Uxbridge (Con) [V]]

My noble friend just stated in a previous answer that that Her Majesty’s Government aim to recognise the certificates of those who have been double vaccinated in other countries, notably the US and the EU. Surely, if we want other countries to recognise our own NHS certificates, it should be reciprocal. Can he give me any idea when this might happen?

[Lord Bethell (Con) [V]]

[Inaudible]—are engaging with a range of international partners, including the EU and the US, on mutual recognition. Ministers have agreed to begin the formal process of reaching a technical agreement with the EU on mutual recognition of vaccine certificates. This would allow the digital verification of vaccine certificates between the UK and the EU. We believe that this process could be complete within a month, pending the Commission’s acceptance of our application.

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

My Lords, have the discussions with these countries involved the question of herd immunity, bearing in mind that countries with low levels of vaccination which have closed their borders will have fewer Covid infections? That could result in less herd immunity in the long term in countries such as New Zealand and Australia, which have closed their borders.

--- Later in debate ---

[Lord Bethell (Con) [V]]

The current data suggests that the vaccine certificate is the most emphatic indicator of reduced infection and therefore transmission. That is the basis on which we are currently looking to try to open the borders. The noble Lord makes the good point that in countries that have had high infection rates some form of antibody recognition might be possible—but that is not the route that we are looking at at the moment.

[The Lord Speaker (Lord McFall of Alcluith)]

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

Organ Tourism and Cadavers on Display Bill [HL]

Lord Bethell Excerpts

2nd reading
Friday 16th July 2021 Lords Chamber

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

My Lords, I thank all noble Lords who have taken part in this very important and wide-ranging debate. I am sure noble Lords will join me in congratulating the noble Lord, Lord Hunt, in once again being successful in the ballot with this Bill—I believe for the third time. I believe that my noble friend Lord Lilley, in the previous debate, had to wait 37 years to get one successful ballot.

My Lords, the unethical harvesting and sale of organs is a terrible crime which disproportionately affects some of the world’s poorest and most vulnerable people. The noble Baroness, Lady Finlay, gave a macabre history of this crime, and the noble Baroness, Lady Northover, rehearsed some of the powerful statistics, while my noble friend Lord Moynihan gave some of the clinical context. All that is to say that I want to make it clear that the Government stand adamantly opposed to any commercial trade in organs and any non-consensual harvesting of organs anywhere in the world. We have signalled our position on this on the world stage and towards having safeguards in place, to which I shall come, to prevent it from happening.

We absolutely support the Declaration of Istanbul on Organ Trafficking and Transplant Tourism, which encourages all countries to criminalise organ trafficking and to draw up legal and professional frameworks to promote ethical organ transplantation. We are also a signatory to the Council of Europe Convention against Trafficking in Human Organs, which likewise calls on countries to establish organ trafficking as a criminal offence.

I reassure the right reverend Prelate the Bishop of St Albans that our commitment to tackling organ trafficking is absolutely and clearly established in UK law. Under the Human Tissue Act, it is a criminal offence to give a reward in exchange for an organ, or to seek somebody who would be willing to sell organs. The Act also makes it an offence to receive a reward for supplying or offering to supply an organ. It is an offence to initiate, negotiate or even advertise any of these arrangements, and those guilty of these crimes may receive a prison sentence, a fine or both. Crucially, these provisions also serve to curtail transplant tourism. If any part of an overseas illicit transaction takes place in England, Wales or Northern Ireland, it will constitute an offence.

These arrangements and the Act are supported by regulations on importation. Any organs, tissues or cells being imported must have proof of traceability from donor to the recipient. The Quality and Safety of Organs Intended for Transplantation Regulations 2012 provide that it should be a licence condition for procurement or retrieval of an organ to ensure that consent requirements have been met. The Modern Slavery Act 2015 further supports these provisions by making it an offence to arrange for someone to travel with a view to their being exploited, with “exploitation” including their being encouraged, required or expected to do things prohibited by the Human Tissue Act, which includes the supply of organs for reward. The Act specifically covers the activities of UK nationals regardless of where they travel or the arrangements that take place. 

I completely agree with the noble Lord, Lord Alton, that the evidence, scale and severity of the human rights violations perpetrated in Xinjiang against the Uighur Muslims is far-reaching and paints a truly harrowing picture. The UK Government have led international efforts to hold China to account for its human rights violations in Xinjiang. We led the first two statements on Xinjiang at the UN and have utilised our diplomatic networks to raise the issue on the international agenda. We have backed up international action by domestic measures. On 22 March, under the UK’s global human rights sanctions regime, the UK imposed asset freezes and travel bans on four senior Chinese government officials and an asset freeze on one entity. On 12 January, the Foreign Secretary announced measures to help ensure that British businesses are not complicit in human rights violations or abuses in Xinjiang. We will continue to work with partners across the world to build the international caucus of those willing to speak out against China’s human rights violations.

I shall now focus on some specific areas of concern with the measures in the Bill. First, the Bill’s provision prohibiting travel outside the UK to receive a transplant without free, specific or informed donor consent raises some questions about the status of deemed consent provisions abroad. If this is intended to include deceased donors, the wording of the Bill suggests that a UK resident may be prohibited from receiving a donation in another country that has deemed consent provisions, as deemed consent may not amount to the specific consent of the donor or their next of kin. Secondly, we are concerned that the inclusion of a new explicitly extra-territorial provision may be counterproductive. Thirdly, we are concerned about how the Bill is to be applied in practice, which is always a test for legislation. For example, these proposals would apply in respect of acts and omissions which take place outside the UK and are done by persons with a close connection to the UK.

I emphasise that it is becoming ever more uncommon for UK residents to seek a transplant overseas. Since the days my noble friend Lord McColl talked about of operating theatre friendliness with French kidneys, we have taken massive steps to increase the supply of ethically retrieved organs in the last few years.

We are aware of a total of 566 cases of UK residents travelling abroad for organ transplants in the last 20 years. Only 179 of these cases date from 2009 onwards, after the introduction of the UK living kidney sharing scheme. We expect the introduction of deemed consent in England—which the noble Lord, Lord Hunt, sponsored and which has already led to 296 people donating 714 additional organs for transplant—to greatly support this downward trend. Although we believe that most of these cases represent legitimate donations, I think we can do more to make sure that any desperate UK patients who may be contemplating purchasing an organ overseas are fully aware of the law, the serious medical risks involved and the terrible consequences that organ trafficking has on the lives of others.

I want to be helpful. Therefore, I commit to this House today to step up efforts with the Human Tissue Authority and NHS Blood and Transplant to promote more awareness of this issue through their websites, social media and their connections with professional societies, transplant centres and clinical communities so that everyone plays their part. I also plan to convene a round-table event with the Human Tissue Authority, NHS Blood and Transplant and members of the stakeholder forum to discuss what further action is needed and how the Government can help.

We will also consider what further steps we can take to increase interagency working between NHSBT, the FCDO and the Home Office to improve understanding of, and facilitate legitimate travel into the UK by a donor from outside the UK donating to a UK resident. I pay tribute to my noble friend Lord Ahmad’s engagements on this issue with the WHO. I am also very keen that we use excellent initiatives such as the Tribute to Life project, which will launch in Birmingham next year, to share knowledge and expertise and increase ethical organ donation for the benefit of all Commonwealth citizens, regardless of transplant infrastructure. I pay tribute to the noble Baroness, Lady Finlay, for her involvement in this important initiative, which the Government wholeheartedly support.

Following the points of the noble Baroness, Lady Thornton, I turn to Clause 2, which seeks to prevent the public display of imported bodies and body parts without proof of the donor’s consent. As my noble friend Lord Ribeiro stated, six months ago, during the passage of the Medicines and Medical Devices Act, my noble friend Lady Penn committed in this House to take forward and ensure that robust assurances on consent were fully received, considered, assessed and recorded before any display licences could be issued.

To meet this commitment, we asked the Human Tissue Authority to strengthen and revise its code of practice. I am pleased to say that the new code, which was laid before Parliament on 10 June, is absolutely clear: the same consent expectations should apply for imported bodies and body parts as apply for such material sourced domestically. To respond to the noble Baroness, Lady Thornton, who summed up very clearly on this, I say that because of this change, for an exhibition such as “Real Bodies” to receive a licence, it would need proof of the donor’s specific consent to be displayed publicly after death. If it failed to provide such proof, it would be denied a licence by the Human Tissue Authority for not meeting its standards.

I again thank noble Lords who have spoken today for their impassioned concern towards the ethical donation of bodies and organs. The Government agree wholeheartedly that this is an important issue, but it is one that our laws already address, although we can do a lot more to increase awareness of the dangers involved. Therefore, I advise that the Government have expressed their reservations and oppose the Bill.

Elderly Social Care (Insurance) Bill [HL]

Lord Bethell Excerpts

2nd reading
Friday 16th July 2021 Lords Chamber

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

My Lords, I congratulate my noble friend Lord Lilley on securing time for the Second Reading of this important Bill. I thank him for bringing forward this challenging legislation, which addresses the pressing issue of unpredictable and catastrophic adult social care costs. Nothing could be more salient. As he said, my noble friend Lord Lilley brings 37 years in Parliament and seven years in Cabinet to bear on this, and it shows. His Bill is a most thoughtful and intelligent proposal to address an electric issue that has confounded policymakers for a generation and now engages the best minds in government.

I very much note the mood of the Chamber and in particular the supportive comments by the noble Lord, Lord Wigley. I cannot promise that the Government will support the Bill. However, I assure my noble friend that we have carefully considered its points and that its insight has provoked a timely dialogue.

Clause 1(1) is on the measures for insurance to be delivered through a public not-for-profit company owned and guaranteed by government. As my noble friend Lady Neville-Rolfe rightly points out, social care should lend itself to risk pooling. Many of us are likely to need care at some point in our lives. Three out of four adults over the age of 65 will face care costs at some point. Half will face care costs of less than £22,000, but around one in seven will face costs of more than £100,000.

Despite this, as my noble friend Lord Lilley pointed out, affordable financial products to provide protection against unpredictable and catastrophic care costs are currently unavailable. A small insurance market grew momentarily in the 1990s, but noble Lords should note that insurers cited both supply-side and demand-side difficulties. The fact that there is currently no private market for insurance does not mean that there is no case for insurance. Singapore has a government-run insurance scheme, voluntary for people born before 1979. The Bill shines a valuable light on a classic but none the less long-standing and damaging market failure. It therefore provides a strong case for government intervention.

Clause 1(3) specifies that the purchase of the insurance should be voluntary and that

“home owners who choose not to purchase the insurance continue to be subject to existing regulations regarding the provision of social care.”

The current means-tested system is based on personal responsibility, with financial help focused on those with the least. It is appealing that the Bill builds on this principle, offering people the option to pool the risk of needing care but placing a responsibility on individuals to plan for care.

Clause 5, on timing, sets out that the insurance offer should be targeted specifically at those approaching state pension age. At this age, still relatively few people need care and it is unlikely that people can accurately predict whether they will eventually require care. Among those aged 55 to 64, only 5% receive formal or informal care, compared with 13% of those aged 75 to 84 and 33% of those aged 85 or over. In response to the point from the noble Lord, Lord Best, this mitigates against the risk of only those who know they will need care choosing to buy insurance, driving up prices. This also allows the insurance to pool both longevity risks and the risk of needing care in the first place. This in turn should help keep premium costs down.

The measures in Clause 2(6) and 2(7) set out that the insurance premia should be

“set at a fixed fraction of the value of the property, net of mortgage.”

This means that someone with significant housing wealth would pay more for the insurance than someone with only modest wealth.

The Bill makes an important comment on the current system. Someone with a care journey of, say, two years in residential care, at cost of £700 per week, with an income of £9,200 a year and starting wealth of £50,000, could deplete up to 57% of their wealth, whereas someone with wealth of £250,000 would deplete only 23%. The Bill has the commendable feature of being both progressive and affordable—a challenging combination.

Clause 3(1) describes that the insured person would be entitled to pay for the premium through a charge on their home realised upon the death of the insured person or the sale of the property. The Bill picks up on an important point here. Even if the cost of the insurance policy were just a small fraction of the value of one’s home, not everyone would be able to afford to pay for it from their savings. After all, as my noble friend Lord Lilley described in clear detail, many people have only limited wealth other than what is tied up in their home. Nearly half of adults over the age of 65 have savings of less than £25,000 and 36% have savings of less than £12,500. Of course, people could draw on their pension pots, but this may be subject to income tax. Therefore, allowing people to pay for the insurance by releasing some of the value of their home prevents people having to sell their home to pay for the insurance. The attraction of this was well described by my noble and learned friend Lord Mackay, and I note the similarity with deferred payment agreements. All this illustrates the strength of the Bill and my noble friend’s proposals; his timing is also impeccable.

Some noble Lords made clear their objections and have emphasised the huge sense of challenge around social care. The noble Lord, Lord Davies, noted the vagaries of the property market and the spread of tenure. The noble Baronesses, Lady Merron, Lady Chakrabarti, Lady Bryan, and the noble Lord, Lord Foulkes, made passionate cases for a nationally funded public social care service. My noble friend Lady Altmann called for a national health and social care insurance premium. The noble Baroness, Lady Greengross, raised the huge challenges of intergenerational fairness. My noble friend Lady Wheatcroft, urged the importance of investment in healthy lives, diet and exercise to minimise social care costs. These are all important points.

The Government’s objectives for reform are to enable an affordable, high-quality and sustainable adult social care system that meets all people’s needs. Every person should receive the care they need, provided with the dignity that every person deserves. The noble Lord, Lord Hendy, was very emphatic in describing the importance of a social care workforce as critical to our ambitions for raising the quality and access to social care. He is right in this. I therefore reassure my noble friend Lady Verma and the noble Lord, Lord Hendy, that in his first few days in his new role, the Secretary of State for Health and Social Care wrote a letter addressed to social care staff with a promise to do all he could to support the sector in the future. I say to the noble Baroness, Lady Watkins, that the Prime Minister has been very clear that we need a long-term plan for social care. As she will know from today’s papers, the details are emerging as we speak. With these things in mind, I once again thank my noble friend for his valuable contribution and express my gratitude to him for his Bill.

Covid-19

Lord Bethell Excerpts

Thursday 15th July 2021 Lords Chamber

[Baroness Brinton (LD) [V]]

My Lords, the Prime Minister told us 10 days ago that we were heading for “freedom day” and that all the data was going in the right direction; all restrictions would be lifted, and now was the time to take personal responsibility for our behaviour and for the Government essentially to step back. The Secretary of State’s Statement on Monday confirmed that, although with a marginally more cautious note about taking care. I echo particularly the comments made just now by the noble Baroness, Lady Thornton, about the mixed messaging in the new guidance for business and on returning to work, which conflicts with what was said both in the Statement and by the Prime Minister.

However, since the Prime Minister’s and Mr Javid’s confident assertions on Monday, there has been an outpouring of disbelief from senior scientists and doctors. Cases are currently doubling every nine days, and yesterday there were 42,000 new daily cases—a level last seen at the beginning of the January total lockdown. If there is no slowing of that doubling rate, we will have hit 100,000 new daily cases by the beginning of August. And that is before the Government’s expected extra cases as a result of “freedom day” on Monday.

Ministers constantly say that there are fewer people in hospital, that fewer people need ventilation and there are fewer deaths, but what they do not mention is that those numbers are a matter of ratios, and that with the current level of cases our hospitals are already reporting A&Es with the equivalent of a winter surge and more wards being turned into Covid wards for patients. A letter published a few days ago in the BMJ, initially signed by 1,000 doctors, is at over 7,000 signatures and still rising. The data is already clear that the surge in new cases from three weeks ago is increasing hospital admissions right now. So what are the Government doing to support and protect our NHS from this sharp increase and pressure on doctors, nurses and hospitals right now?

While many people are being responsible, still following the guidance and using their face masks, sadly there are many who are not. I was talking to a young security guard who told me that, this week, she is finding it impossible to persuade people to put masks on in their local shopping mall, despite the fact that the rules are still in place. Yesterday, my local community pharmacist told me in despair that two people arrived separately asking him for PCR tests as they each had Covid symptoms and thought all the previous rules had just finished. Not for the first time, much of this is about the Prime Minister’s muddled communication style. In the light of the fact that Scotland, Wales and Northern Ireland are going to retain the face mask mandate, and that the metro mayors, including Sadiq Khan and Andy Street, would like to do so, will the Government please reverse the lifting of the face mask mandate immediately, so that it remains in place, especially on public transport?

I turn to the new guidance for the clinically extremely vulnerable. I have to say that I have never read such an inconsistent and contradictory formal guidance note from the Government—and I have read a few. You should stay at home to be safe but if you cannot work from home, go in; you must remain socially distanced from everyone outside your bubble, even if they do not have to; you must not mix with unvaccinated people, outside or inside. I ask the Minister to tell me how on earth you know who is unvaccinated. As one of the CEV, do I stand in the doorway at opening time at my local greengrocer’s—a quiet time—and shout out to any customers and staff, “Anyone not vaccinated in here”? Of course not. The inevitable logic of this is the restart of shielding but without any of the previous support.

Worst of all, on Friday evening Public Health England put out a press release in which it mixed up advice to the clinically vulnerable and the clinically extremely vulnerable by citing vaccine efficiency research relating to the former in advice to the latter. That paragraph has been repeated in the formal guidance published on Monday. It is plain wrong. In a total administrative muddle, no one has gone through the nine pages of this guidance and updated it, so it is littered with references to the need to follow other rules and guidance for the general public in place at 17 May and 21 June, all of which goes next Monday. Please will the Minister ensure that the guidance is reviewed immediately to remove these anomalies?

All this, and the lack of answers to my questions last week about who the clinical lead is on the clinically extremely vulnerable, tells us 3.8 million former shielders that we have been not just forgotten but thrown to the wolves. Please will the Government actually review the guidance to keep the CEV group safe and provide the support that they need?

I also gave the Minister notice of the following two questions, as they both concern urgent and slightly unusual elements of lifting restrictions. First, for a couple of weeks now, Malta has said that it will not accept UK citizens who have received particular batches of the AZ vaccine manufactured in India, about 5 million doses of which have been given in the UK. Earlier this month, the Prime Minister reassured the press, saying:

“I am very confident that it will not prove to be a problem.”


However, holidaymakers are being turned away from Malta right now. When will the Government resolve this problem?

Secondly, those thousands of wonderful people who came forward to take part in the AstraZeneca clinical trials have been told that their vaccine status cannot be put on the NHS app, which means that they cannot go abroad, either to work or on holiday, or do certain jobs in the NHS that require this evidence. In early June, there was a blog on the BMJ website that set out these problems, but three months on from this issue being initially raised, there is still no resolution. It is utterly wrong that these publicly-minded people have now been left in limbo. Can the Minister say when this problem will be resolved and their vaccine details uploaded?

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

My Lords, I am enormously grateful to the noble Baronesses, Lady Thornton and Lady Brinton, for their thoughtful questions. The noble Baroness, Lady Thornton, put it extremely well: we are at a delicate inflection point. It is a moment when the whole country needs to be cautious about rushing into change, but it is also a moment when the vaccine is having an enormous impact and change is therefore appropriate.

Infection rates are rising dramatically, but we cannot avoid the fact that hospitalisations and deaths are holding relatively steady. Today, there are 2,970 Covid patients in beds and 470 on ventilators. This is a massively smaller proportion than in the pre-vaccination spikes, when the connection between infection, hospitalisation and death was much firmer and more profound. At the same time, as the noble Baroness, Lady Thornton, rightly pointed out, waiting lists are huge and the gap for diagnostics for severe diseases, such as cancer, is extremely concerning. It is our responsibility to step up to that deficit and not be wholly distracted by Covid. This is therefore a moment when we have to balance competing demands on our healthcare; we are trying to hit the right balance.

On masks, I pay tribute to the Lord Speaker for his leadership in this area and on asymptomatic testing. I saw his Twitter post where he was being swabbed for his LFD test—a commendable sign of leadership. He and the noble Baroness, Lady Brinton, are entirely right: we should wear masks out of consideration for others, including others who may not have had the vaccine or may not be able to have the vaccine. However, it is also entirely right that central government cannot mandate every aspect of human behaviour for months and years to come. I take great pleasure in the sight of local leaders using their influence to inspire the public in this matter. I remind the noble Baroness, Lady Brinton, that DPHs are able to bring in mandatory measures where there are areas of outbreak. People need to know that the wearing of masks has an impact, and we are hopeful that they will go along with that. Although legal restrictions are being removed, the guidance will recommend that masks continue to be worn in certain situations, and businesses will be encouraged to support staff and customers who continue to wear masks.

In line with businesses, public services have always been free to set their own entry policies as long as they meet their existing obligations, including under the Equality Act. Public services must continue to protect workers and others from risks to their health and safety, including from Covid. That is only right and fair.

On the very important question of the immuno- suppressed and the immunocompromised, both noble Baronesses made extremely powerful points. I want to express in very clear terms my personal sympathy for all those who have concerns about the impact of the vaccine and for whom the rise in infections presents a very real threat to their health. However, I flag the Public Health England report on the clinically extremely vulnerable group as a whole. It makes it clear that there is little reduction in vaccine effectiveness for them compared to those who are not in high-risk groups, with between 76% and 93% effectiveness after a second dose. The PHE data also suggests reduced effectiveness for the immunocompromised and the immunosuppressed, particularly after one dose, but effectiveness after two doses is much higher. These general figures mask substantial variations, which we have discussed before—we would expect this between one set of compromised systems and another—but future studies will provide much more granularity on that. It is not right, however, to suggest that all those with compromised immunities are left unprotected by the vaccine.

The guidance for those who are clinically extremely vulnerable was updated and published on 12 July, as the noble Baroness, Lady Brinton, pointed out. This confirms that changes to social distancing rules in step 4 will also apply to the CEV, who are advised to continue considering additional precautions that they may wish to take on board. I hear very clearly the noble Baroness’s points about anomalies in the guidance; I will take those back to the department and try to tidy up the documentation as she advises.

I can inform the House that we are writing to NHS clinicians to update them on them on the latest position regarding vaccine effectiveness for these groups and provide information on potential treatment options currently under development, such as monoclonal antibody therapies and novel antivirals, as well as access to antibody testing. This guidance will support clinicians in their conversations with patients. This is such a variegated group that that kind of personalised advice is critical.

The interim JCVI advice is that all clinically extremely vulnerable people, including immunosuppressed individuals and their household contacts, should be prioritised for a booster vaccine in the autumn. We are continuing to invest in the OCTAVE study, which will provide further data on patients with suppressed immune response. Interim results for the immediate response to the vaccine will be available from the middle of July.

We are absolutely focused on ensuring that the population is given clear guidance. The NHS app is undoubtedly an area that needs to evolve. Its effectiveness as a technological tool in giving people counsel and advice when they have been in close proximity to someone with the infection is extremely valuable. We are looking at ways in which that value can be enhanced.

On the specific question of the noble Baroness, Lady Brinton, about Malta, it is for member states to determine what they accept at their borders regarding vaccines. Foreign travel advice recently published for Malta misleadingly reported that it would not accept the specific batches received from the Serum Institute of India in the UK. This has now been resolved with agreement from the Maltese Government, and Malta is now accepting proof of vaccination from any Covid vaccine administered in the UK.

Turning to those who, as the noble Baroness, Lady Brinton, rightly pointed out, stepped forward for the critical AstraZeneca vaccine clinical trials, being on a vaccine trial absolutely should not disadvantage them. The Government intend to take any action available to ensure that that is the case. We are working with clinical research sites to add participant information of vaccine clinical trials to the national immunisation management service—NIMS—to allow participants to access their NHS Covid pass for both domestic and international travel purposes.

[The Deputy Speaker (Baroness Fookes) (Con)]

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. I understand that the noble Baroness, Lady Watkins of Tavistock, has withdrawn so I call the noble Baroness, Lady Stroud.

[Baroness Stroud (Con)]

My Lords, on 9 July a Department of Health and Social Care press release claimed that, for those who are immunosuppressed, vaccine effectiveness after a second dose is 74%, with

“similar protection to those not in an at-risk group.”

But this was based on an extremely small sample size. In response, Blood Cancer UK’s chief executive Gemma Peters said that

“its ‘confident, definitive assertions’ about the level of protection given to the UK’s 230,000 blood cancer patients could not yet be supported by the ‘wider body of evidence on vaccine efficacy in the immunocompromised’”.

I am aware that my noble friend the Minister has already commented widely on this issue, but could he comment specifically on those with cancer, particularly those 230,000 blood cancer patients? What intention do Her Majesty’s Government have to clarify this guidance and ensure that the immunosuppressed have access to the necessary resources to help improve their understanding and decision-making?

[Lord Bethell (Con)]

My Lords, the position of the immunosuppressed is one that we have a huge amount of sympathy for. Those who have blood cancer face a particular challenge. I was very grateful to meet Blood Cancer UK and discuss this matter. The PHE report makes the very clear point that those with suppressed immune systems may have a very strong vaccine response, particularly after two weeks after two doses. Just because someone has a suppressed immune system, it does not mean that the vaccine has left them completely unprotected. I completely accept that the responses of one group and another group may be quite different and it is difficult to lump everyone together. That is why we are investing in the OCTAVE study; I am hopeful it will be published by the end of the month. That will provide some, but not all, the information we need to elaborate on that guidance.

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

My Lords, with government scientists predicting that up to 4,800 people a day could be admitted to hospital with Covid if England rushes back to normality at the same time as health experts are predicting a surge in flu and other respiratory viruses likely to lead to severe pressures on the NHS, what contingency plans are the Government putting in place to deal with these pressures without leading to the backlog of other much-needed care and treatment growing ever bigger? Will these contingency plans be published?

[Lord Bethell (Con)]

My Lords, we acknowledge the risks. The noble Baroness is entirely right about flu; the relatively low levels of both flu and RSV in the last 18 months mean that many will not have the immune system that they normally would, and flu is a present danger. That is why we are working so hard on the flu vaccine programme and bundling Covid boosters and flu vaccines for those in the right prioritisation lists. I encourage absolutely everyone to make sure they get their flu vaccine when it comes around. Given the range of uncertainties, we are working with the NHS on its plans for this winter. We will ensure that the service has what it needs to meet those challenges.

[Baroness Massey of Darwen (Lab) [V]]

My Lords, what progress is being made in negotiations with the USA for double-vaccinated citizens of both countries to travel between the two countries, with non-NHS vaccines being accepted and without quarantine being required?

[Lord Bethell (Con)]

My Lords, following the G7 we pulled together a joint task force with USA colleagues to address the precise point that the noble Baroness alludes to. That joint task force is working extremely hard to resolve the various practical, epidemiological and virological arrangements for the kind of green-list corridor that we would like to have between our two friendly countries. I am hopeful we will be able to make announcements on that shortly.

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

I would be most grateful if the Minister could follow on from the question of the noble Baroness, Lady Tyler, and tell us when these plans will be published. The statement says

“we do not believe that infection rates will put unsustainable pressure on the NHS”,

yet we know that the lambda variant, if it should come into the UK and spread, is probably antibody resistant. We know that already, last weekend, some emergency departments had waiting times of around eight hours because they were under such pressure from patients plus staff sickness. We know that it is completely inhumane to expect parents of a sick baby to go into work if the child has RSV during the winter, so those members of staff will inevitably take unpaid leave if they are not allowed to take leave to look after their child.

[Lord Bethell (Con)]

The challenge presented by workforce illness in the NHS is acute at the moment. It is one we are very conscious of, and the noble Baroness is entirely right that parents who have a sick child must stay at home. Not only is that humane; it is also infection control wisdom. That puts the pressure on. That is why we have prioritised vaccination among healthcare staff, and we are prioritising the boosters for staff.

In terms of managing emergency services, we are conducting a huge marketing campaign around the use of NHS 111 so that people can book their slot and be directed to the right kinds of services because, as the noble Baroness knows, many people who turn up in emergency departments are not necessarily in the right place for the conditions they present.

In terms of variants of concern, we are keeping an eye on lambda, beta and all those that may present a vaccine escape risk. We will take whatever steps necessary to address their threat.

[Lord Lancaster of Kimbolton (Con)]

My Lords, I remind your Lordships’ House of my interest as deputy colonel commandant of the Brigade of Gurkhas. Since I last raised the plight of unvaccinated Gurkha veterans in Nepal, I am delighted that the Government have acknowledged their duty of care to them under the Armed Forces covenant. Previously my noble friend has said that our priority is to vaccinate “our people” in the United Kingdom. Now that we seem to be struggling to find people to give the first vaccination to, since there are fewer than 50,000 per day, can I simply ask him again when we will vaccinate our people —our Gurkha veterans are absolutely “our people”—in Nepal? When will they get their vaccines?

[Lord Bethell (Con)]

My Lords, I pay tribute to my noble friend for his campaign on Nepal. His remarks are heartfelt, understood and heard clearly. We all recognise the debt we owe, not just to those from Nepal who have served in Her Majesty's Armed Forces, but their families and the entire nation for their contribution throughout Britain’s history. The PM has announced that the UK will donate 100 million doses over the next year, and the majority of those will be donated to COVAX. My honourable friend in the Foreign, Commonwealth and Development Office will be best placed to clarify the precise arrangements and where Nepal will stand in that supply chain.

[Baroness Chakrabarti (Lab) [V]]

I wonder if the Minister could help me a little with the Government’s logic. Care home workers on zero-hour contracts are to be forced to get vaccinated without even a single guaranteed paid day off to recover from side-effects. A significant step change on domestic Covid passports is to be decided on by businesses themselves and regulated by them, despite all the problems with testing and tracing. Yet something as light touch and common sense as wearing a mask in shops and on public transport is not to be a legal requirement. What is behind this mask aversion and confusion—scientific evidence or Trumpian culture wars?

[Lord Bethell (Con)]

My Lords, in terms of care home staff vaccination, we are in the midst of a consultation on the subject. The noble Baroness should not necessarily pre-empt the consultation. We take into account the views of those we are consulting with. It is a measure that has caused an enormous amount of concern both here in the Chamber and with the public. It feels right that we should be consulting on a measure that ultimately protects the elderly and vulnerable.

In terms of certification, the ultimate use of certification in domestic surroundings has not been fully decided. At this stage, with the country enjoying the benefit of the vaccine, it seems right to be leaving that to businesses to decide how they wish to use it themselves.

[Baroness Wheatcroft (CB)]

My Lords, I want to follow on from the question from the noble Baroness, Lady Chakrabarti. The Government believe that passive smoking poses risks to individuals; hence they ban smoking in offices, pubs and other public places. The science has persuaded the Government that, during a pandemic, the wearing of masks in public places helps prevent individuals from passing on Covid to others, which even those who have been double vaccinated can do. In the Statement, the Government say that it is expected and recommended that masks will continue to be worn. Can the Minister explain why smoking should be governed by government diktat, but mask-wearing should be a matter of personal choice?

[Lord Bethell (Con)]

The noble Baroness makes her points extremely well. I support the ban on smoking in public places for exactly the reasons she describes. However, I do not support a mandatory, legal ban on sneezing, although I do not like people sneezing in my presence. We have to strike a balance between mandation and voluntary arrangements. We also have to choose the right people to make these decisions. Central Government cannot make every single decision on every single matter. I recognise the concern of both the public and of noble Lords in this Chamber about masks. It feels right to leave it to local decision-makers, politicians and companies to take the public with them and to enforce this measure which, I entirely agree, is of benefit to us all.

[Lord Haselhurst (Con) [V]]

My Lords, with the number of infections rising and restrictions continuing to ease, can my noble friend say whether the supplies of vaccines and the capacity to administer them allow the vaccination programme to be further enlarged? This would give us a better chance of overcoming the undoubted risks which, unfortunately, remain.

[Lord Bethell (Con)]

We have an established vaccine run rate and programme, and we have in place the supplies to meet those targets and to fulfil the commitment to vaccinate all those who step forward for vaccination by the end of July. My noble friend may be referring to either a third or booster shot with a variant vaccine. Negotiations and clinical studies are taking place at the moment. We are cognisant that the vulnerable, elderly and those in high priority groups may need further vaccination in the autumn. We are putting in place all the plans necessary to deliver this.

[Lord Whitty (Lab) [V]]

My Lords, I return to the confusing advice on masks. In the early weeks of the pandemic, some of the worst levels of deaths occurred among transport workers. They were inevitably faced with potential infection for several hours a day. It was particularly true of bus drivers, including a very good friend and neighbour of mine who died from Covid a few months before his retirement. With the advent of compulsory mask-wearing on public transport, driver hospitalisation and deaths fell dramatically. With rising infections and more unpredictable variants, what on earth is the rationale for not making masks mandatory on public transport and in other situations where staff are dealing with an increasingly maskless public?

[Lord Bethell (Con)]

I thank the noble Lord for that very touching personal testimony about his neighbour who passed away. It is an important account of many who have put themselves at risk. The PHE report on high mortality groups includes bus drivers, taxi drivers and many who perform an important public service that puts them in front of the general public and therefore at risk from this virus. We absolutely support the wearing of masks. Published guidance will continue to recommend that wearing a face covering will reduce the risk not only to yourself but to others, particularly in enclosed and crowded spaces. The noble Lord asked about whether mandation should be in place and for whom, and I do not wish to duck his point The mandation of masks on public transport is best left to those who run it, which is why we have moved away from legal rules to an approach that enables personal judgments and the intervention of businesses and local leaders.

[Viscount Waverley (CB)]

My Lords, much uncertainty and changing dynamics surround travel—Malta and the EU have already been mentioned. To flip that around, can the Minister kindly explain the rationale as to why government advice has belaboured ad nauseam travelling from the UK, yet my wife is able to travel to the UK from Portugal?

[Lord Bethell (Con)]

My Lords, our intention is that, later in the summer, those who are fully vaccinated will not have to quarantine when arriving in England from an amber list country. This will benefit the noble Lord’s wife, and I hope she will take advantage of it. When it comes to travel, caution is still the principle because travel exposes us to proximity to people in very confined areas. It also raises the possibility that variants of concern will come back with travellers returning from abroad. We have worked so hard and done so much to keep those VOCs out of the UK that it is not just right to give up these efforts now. Those arrangements are under review and will change if the risk assessment changes.

[Lord Rooker (Lab)]

My Lords, I have listened very carefully to the Minister but I did not quite hear the answer to the questions asked by the noble Baronesses, Lady Tyler and Lady Finlay, about the forthcoming pressures on the NHS. The hospital I was at on Tuesday morning is, I was told, working at full stretch; it is at winter levels in July. Covid is taking up ICU beds and stopping elective surgery now, even before the pressure starts. There are constant references in the Statement about not wanting unsustainable pressures on the NHS, but we are putting such pressures on it by allowing the figures to rip without seeming to have proper back-up services and resources. Can the Minister answer the questions from the two noble Baronesses?

[Lord Bethell (Con)]

My Lords, I thought I had answered the questions put by the two noble Baronesses. I will seek to answer the noble Lord. He is absolutely right: our hospitals are working flat out but this is not mainly because of Covid. As of 11 July, hospital admissions in England were running at 502 a day. As of 13 July, there were 2,970 patients in hospital in England with Covid, of whom 470 were on mechanical ventilation. Catching up on all the backlog—not Covid—is what is consuming the hospitals and making them run so red hot. This is the focus of our healthcare system at the moment, and it will remain so for some time to come. We are under no illusions: there is a massive backlog which includes many people who have not come forward with symptoms of severe disease and will need to be addressed and treated. This is a huge national project that we are undertaking.

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

My Lords, in his answer to the question from the noble Baroness, Lady Wheatcroft, the Minister made a comparison which suggested an equivalence between mask-wearing and sneezing. The website MedExpress says:

“Sneezing is…an involuntary release of air that helps the body to get rid of irritants in our nose and throat”.


Does the Minister wish to reconsider that comparison and acknowledge that mask-wearing is a voluntary action available to everybody?

[Lord Bethell (Con)]

The noble Baroness obliges me to confess that, as a young man, I mastered the art of controlling my sneezing, and I am pathetically proud of this. I should be glad to share the skill with her should we have the opportunity to spend some time together.

[Baroness Prashar (CB) [V]]

I want to return to the question of masks. As we have already heard, the ending of the mandatory wearing of masks is causing anxiety and insecurity among clinically vulnerable people. Would the Minister agree that, given that the wearing of masks reduces the spread of the virus and causes no harm to the economy, it would be sensible to make it mandatory? Secondly, guidance recommends good ventilation in enclosed spaces. What assistance are the Government giving to those who need to install air filtration systems?

[Lord Bethell (Con)]

My Lords, I will be crystal clear on this matter. The noble Baroness is right: the wearing of masks is important—for yourself and other people— which is why the Government continue to recommend that people wear them. However, the question was about mandation, and, as I said earlier, it is not reasonable for the Government to mandate minute aspects of our life in perpetuity. We have made a decision on that and passed the responsibility to individuals, local leaders and those who do outbreak management. I completely understand and hear loud and clear people’s concerns, but, were we to mandate it, what is the option for the country? Are we going to issue tens of millions of fines to those who do not wear masks? If they do not wear them, will we lock them up in prison? We tried extremely hard on that policy, but I am not sure whether it had any further rope to run.

[Lord Balfe (Con)]

My Lords, I welcome the direction in which the Government are now proceeding. I quote from the Statement:

“To those who say, ‘Why take this step now?’, I say, ‘If not now, when?’”


There is regulation fatigue, and the Government are facing up to the need for, let us say, a managed process forward. I draw the Minister’s attention to this statement in the Statement:

“We are today publishing … details of a review that we will be conducting in September to assess our preparedness for autumn and winter.”


Could a copy of that review be placed in the Library so that we can all see what it has to say and, if necessary, offer our observations to the Minister to help the further development of what is turning into a policy that I can be fully behind?

[Lord Bethell (Con)]

My Lords, winter is a challenging time for the NHS, and, during an average winter, seasonal respiratory conditions drive an increased demand for hospital beds, as my noble friend knows. That will add to the already intense pressure that the NHS is under. Plans are being put in place. The circumstances are changeable. If there are any plans whatever that can be published, I will ensure that they are sent to the noble Lord and placed in the Library, as requested.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, the Statement from the Minister says that the Government will

“expand … capacity for genomic sequencing”,

which would help in the detection of any new variants. Could the Minister define how and when that expansion will take place?

[Lord Bethell (Con)]

Enormous expansion has already taken place: we have brought together the existing dispersed genomic sequencing capacity of the country and brought it to bear, both at the PHE headquarters in Colindale and in Cambridge, where a huge array of sequencing is going on. We have also brought sequencing into Leamington Spa, where, as the noble Baroness may know, we have a large industrialised diagnostics centre, so that sequencing can be done as soon as we have turned around the PCR testing. We are running at around 30,000 or 40,000 sequences a week, which is a dramatic increase on the past, but we continue to invest in this capacity.

[Lord Cormack (Con)]

My Lords, would my noble friend give consideration to putting a full-page advertisement in every paper, with guidance? This must be clear, coherent and consistent. Would he also—I am sorry to press him on this again—tell me when this consultation over care-home workers will conclude? President Macron has already decided that this will happen in France. A third of the people who died were in care homes; they are the most vulnerable of the vulnerable. It is essential that those who look after their intimate needs are themselves vaccinated.

[Lord Bethell (Con)]

My Lords, I will definitely consider the idea of a full-page advert, and I am grateful for that suggestion. I would also be very interested to receive a submission from my noble friend to the consultation, and, if he would like to copy me in on it, I would be glad to make sure that it gets through to the right people.

[Baroness Fox of Buckley (Non-Afl)]

My Lords, I have listened carefully, and the mask obsession here seems to mask a certain reluctance to ever allow normal to return, even if it means a terrible toll on jobs, livelihoods or non-Covid health—so I am glad to hear the Minister being more balanced. However, I will bend the stick and ask him whether he will concede that many millions are demoralised that the Government’s irreversible freedom day comes with so many caveats that it feels like parole with an electronic tag and house arrest hanging over us like a sword of Damocles? Can we not get a bit more balance? On data, according to PHE on hospitalisations, of those who spent more than one night in a hospital with the delta variant at the end of June, 39% were patients who had gone to hospital with different conditions—so could the hospitalisations data perhaps be clarified, because I think that that would reduce fear and give a bit of perspective?

[Lord Bethell (Con)]

My Lords, the noble Baroness slightly underestimates the significant step that the Government have made in order to take advantage of the vaccine, try to get the economy moving and address the very considerable backlog that we have in the NHS. The Prime Minister deserves some praise for the way in which he has moved emphatically in this direction. Therefore, I am a little bit surprised that the noble Baroness has not done more to recognise that point. On the data, I would be glad to look at the number that she describes. It is not one that I recognise, but I would be glad to correspond with her on it.

Folic Acid

Lord Bethell Excerpts

Tuesday 13th July 2021 Lords Chamber

[Lord Rooker]

To ask Her Majesty’s Government, further to the reply by Lord Bethell on 3 September 2020 (HL Deb, cols 444–5), whether they have yet been able to form a conclusion on the outcome of their consultation on the proposal to add folic acid to flour which closed on 9 September 2019.

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

My Lords, I am pleased that substantial progress has been made on this work since I spoke to the House in June, including positive dialogue with all devolved Administrations. It is right that we remain committed to proceeding on a UK-wide basis and I am grateful to colleagues in the devolved Administrations for their energy and support. I assure the House that we are progressing this as a priority, and I look forward to updating the House after the Recess.

[Lord Rooker (Lab) [V]]

Can I assume that the Minister is aware of the statement from the Ministry for Primary Industries in New Zealand on 8 July, five days ago, that as a result of its consultation on folic fortification in 2019 it will fortify all non-organic wheat flour from mid-2023 and therefore join Australia and more than 80 other countries in mandatory fortification? Why are we so far behind New Zealand? The women of New Zealand had the vote 30 years before British women. Can I be assured that British women will not have to wait as long to have safer, healthier pregnancies and fewer babies with a lifelong disability?

[Lord Bethell (Con)]

My Lords, I pay tribute to the Government of New Zealand for focusing on this important issue and to the energy and passion of the noble Lord in his advocacy in this matter. I can give him the reassurance he asked for. This is a priority for the Government. We are taking it through the machinery of the British Government to ensure that it is rolled out safely, extensively and on a nationwide basis.

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

My Lords, assuming that the Minister is able to come back to the House after the Recess and give the green light, can he say when we could implement this policy? Does he agree that the recent report of the Health Select Committee on maternity services underlined the importance of making this decision soon?

[Lord Bethell (Con)]

My Lords, it is not only its importance for maternity services that is on my mind. It is also the recently announced office for health promotion, which will lead the national effort to improve and level up the health of the nation in the round by tackling obesity, improving mental health and promoting physical activity. This important initiative should be seen in the context of that important strategy. I completely endorse the ambition expressed by the noble Lord.

[Baroness Jolly (LD)]

My Lords, why does the Minister tease the House? He says that fortification should happen, so there is no disagreement, but it does not happen. In June, just over two weeks ago, he said that

“we are committed to following the science and are totally persuaded by it … I reassure noble Lords that this remains a priority for the Government.”—[Official Report, 23/6/21; col. 221.]

Since that Question, 50 more babies will have been born with neural tube defects. This will not do. Has the Minister sought the view of the new Secretary of State? Could he share it with the House?

[Lord Bethell (Con)]

I look forward with great enthusiasm to my monthly updates to the House on this important initiative. We are moving as quickly as the machinery of government allows us to. Taking along all the nations is an important aspect, but, quite fairly, it requires consultation with and the engagement of the devolved assemblies, which is why we have written to them and are engaging with them accordingly. I am also pleased to share with the noble Baroness that we are actively engaged with Defra, which is undertaking a wider review of bread and flour regulations. We will be aligning its fortification plans with this measure in due course.

[Lord Moynihan (Con)]

My Lords, I congratulate the noble Lord, Lord Rooker, on his campaign, which I strongly endorse. Further to the question from the noble Lord, Lord Hunt of Kings Heath, will my noble friend at least set out the draft timetable for the implementation of this measure before the House goes into recess?

[Lord Bethell (Con)]

My Lords, I am looking forward to outlining the draft timetable, but I will not be able to do so before the Recess.

[Baroness Finlay of Llandaff (CB)]

My Lords, following on from the Minister’s answers, can he tell us whether a provisional target date has been set with the devolved nations for the implementation? Given that we know that 90% of women aged 16 to 49 currently have folate levels below that required to reduce the risk of neural tube defects and that 70% of adults—that includes men—have folate levels so low that they are at risk of anaemia, this is an urgent problem.

[Lord Bethell (Con)]

My Lords, I share the sense of urgency expressed by the noble Baroness in her articulation of those statistics. They are both worrying and entirely accurate. We very engaged with the devolved assemblies. Welsh and Scottish Ministers have expressed their support, but with Northern Ireland it is important that we consider all the implications of the Northern Ireland protocol. I am therefore not able to lay out the precise timetable now, but I reassure the noble Baroness that we are moving as quickly as we can.

[Baroness Merron (Lab)]

My noble friend Lord Rooker continues to press to protect newborn babies while, sadly, the Government have over a number of years continued to drag their feet. In preparation for the Minister’s forthcoming update, which he has promised the House today, what assessment have the Government made of the impact of the Covid-19 pandemic on the financial and practical ability of women to access prenatal vitamins, including folic acid? How has the pandemic affected awareness-raising to ensure that women are not missing out on vital nutrients in the early stages of their pregnancy?

[Lord Bethell (Con)]

I am sorry, I cannot answer the noble Baroness’s question directly. I am not sure whether an assessment has been made of the impact of the pandemic on the consumption of folic acid, but it has undoubtedly raised the importance of these kinds of preventive measures. We have never been more acutely aware of the importance of improving the health of the nation, and this is an important step in that direction.

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

My Lords, one of the first to indicate that folic acid could prevent spina bifida was Professor Richard Smithells in 1980. That was accepted 11 years later, which is nothing compared with the present delay. Spina bifida is one of the commonest congenital defects and is easily prevented by adding folic acid to flour, which is what the Americans did 23 years ago, thus preventing 1,300 babies having that tragic condition every year. We keep hearing about consultations and meetings, which some of us regard more as group psychotherapy than as achieving anything. When will action be taken?

[Lord Bethell (Con)]

My Lords, I completely understand and appreciate the sense of frustration and urgency that my noble friend expressed, but I emphasise that this is a massive national measure. It has to be conducted in a way that takes the nations with us, that people feel confident that the right processes have been adhered to and that there is no doubt about the safety of the measure. This is not a question of foot dragging, quite the opposite. We are doing this in a thorough way that reflects the practicalities and realities of the machinery of the United Kingdom Government.

[Baroness Hayman (CB) [V]]

My Lords, I understand the frustration the Minister must feel being brought to the House again and again on this issue, but can he understand the frustration just expressed by the noble Lord, Lord McColl of Dulwich, that British science of 40 years ago has influenced the activities of countries across the world, New Zealand being the latest, and yet somehow in this country we have not managed to act on the science that was produced here and families have paid the price for that? Will the Minister understand the urgency and the frustration of those of us who have been raising this issue for years and will he look again at a timetable for implementation?

[Lord Bethell (Con)]

My Lords, I completely understand the frustration. I pay tribute to all noble Lords who have campaigned assiduously for this measure. It speaks extremely highly of this House that it is so focused on getting over the line an important and emblematic measure that puts preventive medicine at the heart of our healthcare system. Personally, I do not feel any disappointment or anger. I am completely committed to this measure, as are the British Government.

[Lord Balfe (Con)]

My Lords, I have been raising this matter since I became president of the British Dietetic Association, and my presidency ended a year ago. It seems that we go round and round in circles. Some 80 countries in the world have solved these questions. Why is it taking HMG so long? Can the Minister assure us that before we break up next week, he will have made a definitive statement on dates?

[Lord Bethell (Con)]

My Lords, I do not need to explain to a seasoned veteran such as my noble friend that the British Government have had a lot on their hands in the past 18 months and that getting right important measures such as this, that touch the lives of every single person in the country—at least, all those who have bred—is an extremely delicate matter. That is why we have to do it in a thoughtful, constructive way. There is no cutting corners on a measure such as this. I reassure my noble friend that we are going through it as quickly as we can. I am not able to give him the timetable that he asks for, but I would like to return in the new term with further details.

[The Lord Speaker (Lord McFall of Alcluith)]

My Lords, all supplementary questions have been asked.

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

Lord Bethell Excerpts

Monday 12th July 2021 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021. Special attention drawn to the instrument by the Secondary Legislation Scrutiny Committee, 8th Report.

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

My Lords, one in three people with coronavirus show no symptoms and are potentially spreading it without knowing. Testing will remain vital to controlling and containing the spread. To do this we will need a reliable supply of high-quality tests available to everyone, giving people and businesses the confidence to be recalled to life.

We should be proud of how we have risen to the challenge of this pandemic. We have grown our national diagnostics capability dramatically, with laboratory capacity now at around 614,000 PCR tests a day. The Government have to date administered 218 million tests in total, delivering around 1.1 million a day. The UK has one of the largest testing diagnostic capabilities in the world.

We have a growing market. More than 1,000 organisations are undertaking accreditation through UKAS to deliver testing services. Tests are already available on the market and their presence is growing, from use in film and sports to huge potential markets in events and workplaces. We estimate that around 97 million LFD kits are reaching our market each week, and this is increasing.

It is therefore clear that the quality of the tests available is critical, yet I know at first hand, through our stringent procurement of tests, that more than 75% of tests that we considered failed. Some tests were up to 17% less effective than they claimed. That means that, in the real world, a highly infectious person would be significantly more likely to get a false negative. These tests do not work in the real world and can in fact harm public health, causing people to spread the disease in the false belief that they are uninfected. Bad tests will increase mortality; I will not stand by and let that happen. Even meeting the low bar of CE marking has proved too much for some. The MHRA has taken action against 80 companies, including seizing approximately 48,000 non-compliant tests.

There is clear evidence of the risk that businesses and individuals can buy tests that are, frankly, not good enough. I will not settle for low-quality CE-marked tests that manipulate their instructions for use or construct their own rigged validation. I will not have them for the NHS and I do not want them mis-sold to my fellow citizens. We must act now. I have already regulated the more mature services side of the market through accreditation, but we must close any loopholes on the goods side by regulating the quality of the tests themselves.

I know it is frustrating for the producer of any high-quality test to see its product lost in a sea of lower-performing tests, often at lower prices, as some rivals have not put in the work to assure their tests and ensure the sensitivity and specificity to be useful in the real world. We want to support businesses developing quality tests through a rigorous validation process. This will set those quality tests apart.

When we conducted a public consultation earlier this year, more than 75% of respondents agreed with the need to implement a minimum performance standard for Covid-19 tests on the UK market. Indeed, one of the consultation responses highlighted:

“Current performance claims are unreliable and can easily make use of cherry-picked data. There are no set standards for sensitivity and specificity to be evaluated against, and therefore no objective way of comparing 2 tests.”


This was also reflected in what manufacturers have told me on numerous occasions. Manufacturers welcome this legislation. Many see this as an opportunity to make the market more equitable and fairer to those who strive to deliver a good product.

A cornerstone of these regulations is the register of quality tests that they will make available to anyone in the world. It will separate the wheat from the chaff in terms of tests. Empowered by this information, individual consumers and companies will be able to make informed, prudent choices when buying kits for themselves, their families or their workforce. This will provide consumers with clear and comparable information, not the miasma of confusion that some companies exploit. Either their test meets the Government’s standards and can be sold or it does not. Any manufacturer that tries to avoid these standards will face the force of the UK’s regulatory enforcement agencies. I am not interested in burdening businesses with bureaucracy but, in return, I expect businesses to engage with the scientific process openly and honestly and, when they fail, to be candid about it.

Although some may see this as a radical intervention in the market, I am reminded of Dr John Snow, the father of epidemiology. When the evidence is clear and you need change to happen quickly, radical action is no vice; it is a virtue. The change can be as simple as removing a pump handle, as Dr Snow did to prove that the source of cholera was in London’s water supply, or acting to ensure consistent standards that bring the best of business creativity to bear for the public good.

I want people to know that the tests they buy will be as good as those they would receive under the NHS, and therefore trust the results. This will empower people to take charge and make their own decisions about managing their personal health. Our experience of the pandemic shows why we urgently need to level up the whole pathology infrastructure in our country. This legislation will not only remedy the immediate market failure but be an example of effective regulation that we can build on in future.

Freedom requires vigilance. If we are to be free of this pandemic, we need a wholesale culture shift in how we manage disease. We are reliant on one another, as fellow citizens in the shop, pub or workplace, to safeguard each other’s health. Each of us needs to take responsibility as an individual. If we feel sick, take a test. If we might have been exposed to someone who was sick, take a test. If we have been somewhere where there is now an outbreak, take a test. This legislation is about empowering people to take personal responsibility for their health and giving them quality tools that they can rely on to do so.

This regulatory regime will not achieve that legacy in isolation but it will be part of the paradigm shift in how we manage disease going forward to a more proactive testing culture. It will ensure a market that provides choice to consumers through high standards and clear information; certainty to producers through clear and consistent regulation; and lessons for government to apply to future regulations. I beg to move.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I start by assuring the noble Lord, Lord Rooker, the noble Baroness, Lady Thornton, and others that when we look at this validation SI, our overarching objective is safeguarding public health. That is the primary impact of this regulatory regime for the validation of Covid-19 tests. I think noble Lords agree that high-quality tests are essential to avoid public health risks in future.

I will just clarify one key point. When I said that 75% of tests did not meet those standards and that only 50 of the 280 we had looked at passed, I meant that we rejected and never bought the 75% and were limited to only a smaller number of suppliers. That created a bottleneck in the supply of tests, which noble Lords will remember as a terrible feature of the pandemic last year which severely inhibited the progress of our campaign against this awful virus.

The importance of tests was bitterly showcased last year because of the dangers of one person potentially causing an outbreak in the whole community. Therefore, the primary purpose of the regulatory regime we are debating today is to safeguard public health.

The UK Government are clear that we want to be a world leader in agile regulation; this will encourage businesses from the UK and elsewhere to research and manufacture tests in the UK. We need that because when the pandemic began at the beginning of last year, we had neither a domestic diagnostic industry nor institutional experience of how to assess and validate tests. Those were functions that we had to build from the ground up. This SI puts in place mechanisms for encouraging a domestic industry and the standards to assess that industry.

British manufacturers and pharmaceutical research and engineering firms have led the way as part of a global effort to combat the virus, keeping the NHS supplied with kit, tests and medicines. We engaged with them thoroughly. A consultation has been published, and I would be glad to distribute it to noble Lords. They resoundingly support these measures.

If companies do not want to improve the quality of their tests to meet our standards, they simply will not sell their tests here. I see the loss of poor-quality tests from the market as positive, as it will leave more market share for high-quality tests. That is a message I give to all those manufacturing tests that cannot make the standards.

I say to the noble Lord, Lord Rooker, who asked a number of perceptive questions about the role of free testing and the policy in this area, that reports in the press are not to be given the credibility he suggests and that we have not moved on as far as he suggests. However, it is true that we have always established the principle that the Government cannot provide every single test for every single purpose. That is for two reasons. For instance, travel is essentially a voluntary matter, and it is not right for the taxpayer to pay for tests that people take in order to conduct a voluntary matter.

The other reason is pragmatic. We will not be able to sustain or have a resilient diagnostic system in this country if the state is the only player and we have no private capacity to lean on. That was our experience last year and it damaged us greatly. Countries that had private diagnostic capacity, such as Germany, survived much better and had much more capacity to lean on. So we are looking to evolve the way we do testing in this country and I will be glad to update the House when those plans are fully formed.

In response to the noble Lord, Lord Rooker, the role of asymptomatic testing will undoubtedly evolve when a large proportion of the country is vaccinated and when vaccination greatly reduces the link between infection and hospitalisation, whereas the role of PCR testing will become more important as we move to a situation where there may be new infection. We hope that R will be below one, and these changing dynamics will have a profound effect on the provision of diagnostics.

In answer to my noble friend Lord Lansley’s questions, we are enormously engaged with UK manufacturers. We have a Make programme, with a substantial team that is fully engaged with the UK diagnostics industry. I pay testimony to SureScreen, one of the key suppliers to test and trace, for the incredibly valuable contribution that it makes to our procurement. I am grateful to all those partners that supply test and trace and the NHS with tests, but we are doing everything that we can to support the UK industry.

In reply to my noble friend Lord Moynihan, the standards are the same for the NHS as the validation for test and trace. We are trying to bring about a situation where the test you take in a test and trace or NHS capacity will be exactly the same one that you take in a private capacity.

On timing, we are moving as quickly as we can and we have heavily resourced this area. In fact, our major constraint has been our desire to take these measures through Parliament in the usual fashion. On costs, the programme currently washes its own face, but we are conscious of the pressure of costs on manufacturers and we very much hope to bring the costs down.

I completely share the sentiments of noble Lords who mentioned trading standards. It has already performed an important task in holding test distributors and service firms to account, and I am enormously grateful for its interventions in the market.

We have completed an impact statement but we are waiting for final comments from the RPC. As soon as it is available we will make the statement available to parliamentarians. We have assessed that the direct costs to business of this policy are made up of £6 million annual equivalent for the validation programme and £165 million in forgone profits for manufacturers either not applying for validation or for products that do not pass validation. As the Covid-19 diagnostic market inevitably shrinks, forgone profits fall year on year from £647 million in year 1 to £35 million in year 6.

On my noble friend Lord Lansley’s question about whether NHS tests will need to undergo validation, all tests used by NHS Test and Trace have already undergone rigorous clinical evaluation, providing confidence in their performance. The Government’s proposals aim to ensure that all tests available in the UK meet the same high standards.

My noble friend Lord Lansley asked about the sensitivity and specificity of the LFD tests, and his points were very well made. The LFD test is for infectiousness. An extremely mild infection that is not in itself infectious will not necessarily be picked up by an LFD in the same way that it will by a PCR, but that does not invalidate the effectiveness of LFDs in breaking the chains of transmission.

On the taking of tests, our experience has been that, after one or two goes, tests taken at home are just as good as those being taken by clinicians in the laboratory. In fact, it is a testament to the British public that they have been as diligent and thorough as they have been in using their swabs.

I completely understand noble Lords’ concerns about the FDA press release and its concerns about the Innova tests. I assure them that MHRA colleagues were entirely involved in the intense conversations with the FDA and have satisfied themselves that the FDA’s concerns were not applicable to the UK market. We continue to maintain the purchasing of Innova tests based on validations that we in the UK have done for ourselves.

My noble friend Lord Lansley mentioned inward investment. We really hope that many firms, both British and from overseas, will invest further in the UK. We are working hard to build up a UK diagnostics industry from relatively humble beginnings into something that is muscular, innovative and makes the very best use of UK science. I hope that I will be able to make announcements on that in the near future.

The noble Baroness, Lady Thornton, asked how the costs of tests will be regulated. The cost to the public will be governed by the marketplace. I am pleased to say that the costs have come down dramatically in the past year; it is my hope that they will continue to come down.

As we move beyond the pandemic, we must consider its legacy. After World War II, our grandparents left us the NHS as its legacy. As they turned their tools and talent against fascism, so too they turned them against disease, and they moved from the business of taking lives to saving them. In the same way, we must ensure that this greatest test of our nation since World War II leaves an equal legacy for our grandchildren. I hope that a revolution to our approach to diagnostics will be that legacy, with proactive, not reactive, healthcare and disease management. I say to the noble Baroness, Lady Thornton, that our intention is for good-quality, well-regulated Covid-19 diagnostic tests to be a small but integral part of that legacy and for us to learn lessons to support the NHS in saving lives for generations to come.

Motion agreed.

Health Security (EU Exit) Regulations 2021

Lord Bethell Excerpts

Monday 12th July 2021 Lords Chamber

Tabled by

[Lord Bethell]

That the draft Regulations laid before the House on 21 April and 7 June be approved.

Relevant documents: 1st and 6th Reports from the Secondary Legislation Scrutiny Committee. Considered in Grand Committee on 5 July.

[Lord Ashton of Hyde (Con)]

My Lords, on behalf of my noble friend the Minister, I beg to move the Motions standing in his name on the Order Paper.

Medical Devices (Northern Ireland Protocol) Regulations 2021

Lord Bethell Excerpts

Monday 12th July 2021 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Medical Devices (Northern Ireland Protocol) Regulations 2021.

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

My Lords, the statutory instrument that we are discussing today relates to the regulations for medical devices within Northern Ireland. It reflects the application of EU regulation 2017/745 on medical devices, which I will hereafter refer to as the EU medical devices regulation, under the terms of the Northern Ireland protocol. As noble Lords will be aware, the protocol agrees to continue applying certain EU rules in Northern Ireland to recognise the unique status of Northern Ireland within the UK and to uphold the Belfast/Good Friday agreement. It is important to remember that this instrument does not apply the EU medical devices regulation within Northern Ireland. That legislation took automatic effect in Northern Ireland from 26 May this year, under the terms of the Northern Ireland protocol.

The EU medical devices regulation contains some flexibility areas, where states have the discretion to make policy decisions and adjustments. This instrument therefore makes provisions to apply in Northern Ireland where it serves to align Northern Ireland policy with Great Britain. This is to deliver the Government’s commitment to the pragmatic implementation of the Northern Ireland protocol. In creating the provisions in this instrument, we are minimising the impact on economic operators and the public in Northern Ireland, as the Northern Ireland protocol pledges.

The Medical Devices Regulations 2002, hereafter referred to as the 2002 regulations, will continue to be the relevant regulations for in vitro diagnostics in Northern Ireland, and will operate alongside the EU medical devices regulation and this instrument on the regulation of medical devices and active implantable medical devices.

I shall give some background. This instrument achieves the Government’s commitment to align Northern Ireland with Great Britain, where permitted, in four areas. First, it implements national adjustments for Northern Ireland in areas where the EU medical devices regulation grants member states the ability to make national policy decisions. This has been done in a way that will align with policies in place in Great Britain. Secondly, it sets out the fee structures that keep fees aligned with those applied in Great Britain. Thirdly, it sets out the enforcement regime for activity and violations under the EU medical devices regulation in Northern Ireland. Lastly, it makes amendments to existing regulations, to take account of the application of the EU medical devices regulation in Northern Ireland.

I will first describe areas of national flexibility where this instrument makes provision to change default positions under the EU medical devices regulation to maintain Northern Ireland policy with that of Great Britain. The Government currently permit the remanufacturing of single-use devices, which the EU refers to as reprocessing, so long as the remanufacturer adheres to strict requirements. The default position of the EU medical devices regulation is not to permit remanufacturing unless there is national legislation in place to support it. This instrument does just that. This means that the remanufacturing of single-use devices can continue to take place in Northern Ireland, as well as in Great Britain, so long as requirements under the relevant legislation are followed.

The instrument also introduces provisions so that the MHRA can continue requiring custom-made devices, ranging from dental appliances to orthopaedic moulds, to be registered before being placed on the Northern Ireland market. Provisions are also contained in this instrument that uphold our national requirements for clinical investigations, which are crucial for ensuring that the safety of participants is protected. They do so by maintaining the MHRA’s ability to authorise clinical investigations for all risk classes of medical devices before they can commence. Furthermore, it upholds the requirement for all clinical investigations for custom-made devices to be subject to MHRA assessment. The Government remain committed to delivering improvements to patient safety, and this instrument means that we can respond proactively to any concerns.

By amending the Consumer Rights Act 2015 and the Medicines and Medical Devices Act 2021, this instrument provides the MHRA and district councils in Northern Ireland with inspection powers and powers to serve enforcement notices for breaches of the EU medical devices regulation within Northern Ireland. This will ensure that the MHRA has the enforcement powers it needs to ensure patient safety is prioritised and high standards are maintained for the people of Northern Ireland.

The MHRA charges fees to cover the costs associated with certain aspects of the regulation of medical devices. This instrument details fees which may be charged for activity under the EU medical devices regulation in Northern Ireland, keeping them identical to those charged in Great Britain under the 2002 regulations for similar services. This upholds the Government’s commitment to ensure that there are no disadvantages to economic operators in Northern Ireland as a result of the Northern Ireland protocol. This instrument does not introduce any fees for new requirements under the EU medical devices regulation.

Finally, this instrument makes technical amendments to other legislation, including the 2002 regulations, to reflect the application of the EU medical devices regulation within Northern Ireland. This will ensure the regulatory landscape operates effectively in Northern Ireland. Officials in the Northern Ireland Executive have been kept informed of the progress of this instrument and I am hugely grateful for their continued collaborative approach. As the nature of the changes in this instrument are technical in many instances, the impacts of the instrument do not meet the threshold for impact assessments, hence these are not provided.

In conclusion, this instrument upholds the Prime Minister’s commitment to the Northern Ireland protocol and to minimise the impact on the activities of economic operators and the public in Northern Ireland. The significance of our public healthcare system has never been clearer than during the Covid-19 outbreak, and this instrument will ensure that the UK’s exceptional standards of safety are maintained within Northern Ireland. This is something we must support. I commend the regulations to the Committee.

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

The noble Lord, Lord Hunt of Kings Heath, has withdrawn, so I call the next speaker, the noble Lord, Lord McColl of Dulwich.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, as a responsible Government, it is absolutely imperative that we deliver on the Northern Ireland protocol and do so pragmatically to minimise the impact on the activities of economic operators and the public in Northern Ireland. As was intimated by the noble Baronesses, Lady Thornton and Lady Brinton, we are trying to find a way through. I believe that this instrument achieves that and, in doing so, ensures that high standards for patient safety are maintained throughout the United Kingdom.

I assure the noble Baroness, Lady Hoey, and other noble Lords who asked similar questions that the Government are fully committed to a system of medical device regulation that prioritises safety and safeguards public health. As such, the department has sought to minimise any disruption to patients and industry by providing consistency in policies where that is possible and ensuring a functioning statute book for the regulation of medical devices in Northern Ireland.

My noble friend Lord McColl asked about an advisory body. No formal advisory body is currently planned, but we will take his suggestion on board. NHS Digital is working with industry on a surgical devices register and, as such, is extremely engaged with industry in the manner to which he alludes. On the matter of deadlines, I agree with him about the importance of high service levels, but that is best left for management, not for secondary legislation. Compensation is covered in a large number of fora, including the courts, and is best left there.

I reassure my noble friend Lord Lansley about the Government’s commitment to unfettered access. As set out in the Government’s Command Paper of 20 May 2020, the UK’s approach to the Northern Ireland protocol ensures unfettered access to Great Britain for Northern Ireland businesses. It protects the territorial integrity of the UK by safeguarding Northern Ireland’s place in the UK’s customs territory and keeps goods flowing between Great Britain and Northern Ireland, applying measures that help to maintain food supplies and, of course, the flow of medicines. This includes access for medical devices from Northern Ireland businesses that are CE or CE-and-UKNI marked. The CE or CE-and-UKNI marking applies to Northern Ireland now and after June 2023.

My noble friend Lord McColl asked about mesh. We wholeheartedly commit to demonstrating to the patients and families who have shared their experiences during the Cumberlege review, and to anyone else who has suffered, that we have learned from them and are changing and improving because of what they have told us. The SI focuses on implementing the EU medical devices regulation in Northern Ireland under the specific powers of the European Union (Withdrawal) Act 2018, which would not extend to making changes to the regulations to respond to my noble friend Lady Cumberlege’s review. The Medicines and Medical Devices Act 2021 provides the powers for future regulations that have patient safety at their heart, and we are reflecting on the lessons from the Cumberlege review for future regulations. We will consider questions on the responses.

The points made by the noble Lord, Lord Dodds, on the 300 manufacturers are extremely well made. I reassure him that we are committed to implementing the protocol, but we must do so in a way that is sensible, balanced and attuned to the unique circumstances of Northern Ireland. As the noble Lord has already noted, my noble friend Lord Frost and the Secretary of State for Northern Ireland have recently made public statements on the Northern Ireland protocol. The Government are carefully considering next steps and will set out their approach to Parliament before the Summer Recess.

I reassure the noble Lords, Lord Dodds and Lord Empey, and the noble Baronesses, Lady Hoey and Lady Ritchie, that the Government are committed to adopting a pragmatic approach to regulatory divergence, seeking to minimise the impacts wherever it is possible to do so. I cannot emphasise enough that the changes contained in this instrument are essential to delivering on that commitment. The instrument does so by providing consistency between regulations in Northern Ireland and Great Britain where we are not constrained by the EU medical devices regulation. The instrument also ensures that when a medical device complies with the EU medical devices regulation and is a qualifying Northern Ireland good, it can be placed on the market in Great Britain without needing to meet any further regulatory requirements.

The noble Lord, Lord Empey, asked about future regulation. I reassure him that for a two and a half year period after the end of the transition period, devices compliant with EU medical devices regulation and EU in vitro diagnostics regulation can be placed on the Great Britain market as part of the UK’s acceptance of EU-regulated CE goods.

In answer to the noble Baroness, Lady Thornton, the UK will be consulting shortly on the future of Great Britain’s medical device regulations which will include a review of the elements of EU medical devices regulation and EU in vitro diagnostic devices regulation which benefit patient safety and patient access. Work on the future Great Britain regulatory regime will explore any risks around regulatory divergence between Great Britain and Northern Ireland.

To the noble Baroness, Lady Brinton, as I said in my opening remarks, by keeping the fees in Northern Ireland the same as those charged for equivalent activities in Great Britain under the 2002 regulations, this instrument ensures that there are no financial deterrents which may cause any disadvantage for Northern Ireland manufacturers or those carrying out clinical investigations.

By way of summing up, I thank noble Lords for their valuable contributions to this debate. I reassure all noble Lords that as a Government we are fully committed to ensuring that patient safety in all parts of the UK is prioritised and that high standards are maintained within Northern Ireland. I am enormously grateful for the support shown by many noble Lords for these measures, and I commend these draft regulations to the Committee.

Motion agreed.

Covid-19 Update

Lord Bethell Excerpts

Thursday 8th July 2021 Lords Chamber

[Baroness Brinton (LD) [V]]

My Lords, one year ago when lockdown was lifted, we had around 1,000 new cases a day. Yesterday it was 32,000 new cases. Equally concerning, cases are doubling every nine days; hospitalisations are going up; ventilation bed occupation is going up; NHS Providers, as the noble Baroness, Lady Thornton, has said, is talking about hospitals moving back into created-Covid wards and managing safe areas. GPs and hospitals are all reporting a worrying large increase in young people with long Covid, putting further pressure on their services, let alone the worries of an epidemic of long-term illness in the working population. Anecdotal evidence suggests that some hospitals are now considering cancelling some staff summer leave. Wonderful as yesterday’s England victory was, the sight of 60,000 fans walking down Wembley Way in very close proximity with hardly a mask in sight was concerning. As with the England-Scotland match, we must expect a surge in cases. Yesterday, the BBC asked Dr Mike Ryan of the World Health Organization about the UK proposals to lift all restrictions on 19 July. He replied:

“The logic of more people being infected is better is, I think, logic that has proven its moral emptiness and epidemiological stupidity”.


The letter in today’s Lancet from 100 senior medics and scientists echoes the WHO view. What are the Government doing to explain to the experts why their strategy is safe?

I will return to the substance of the Statement later, but I start by thanking the Minister for the meeting yesterday with other Peers, Blood Cancer UK and the Anthony Nolan trust to discuss the immunocompromised and the clinically extremely vulnerable. There are over 2 million CEV who had to shield—that is 3% of the population. So, arising from questions I have asked the Minister many times before in your Lordships’ House, I will ask the following. The CEV, of whom I am one, are worried at the total silence to them over recent weeks since shielding ended formally but, with stay-at-home advice still in place, with cases rocketing daily and all restrictions easing, can the Minister explain how advice to them is being co-ordinated publicly by government? One blood cancer patient said today to an APPG of parliamentarians that the dissonance of their safety versus everyone else’s freedom was hard to bear, especially with no advice. In particular, who has clinical responsibility for drawing together the different issues of therapies, responses to vaccines and continuing care for underlying diseases, and which Minister has overall responsibility?

Overnight, there have been some suggestions from journalists that shielding might even return. If so, that needs to be communicated very urgently to those at high risk, who have not been told about their low vaccine antibody rate. They may be planning to mix with people, or perhaps even go on holiday. Will benefit support for the CEV who have to stay at home but cannot work from home be reintroduced? If the Government are serious about the irreversibility of the lifting of all restrictions, some of the CEV will not be able to return to work for weeks, or even months.

I turn to testing. There are reports today that the Government plan to charge for the lateral flow tests from the end of this month. As LFTs are supposed to be the great self-regulators that the Government are relying on, how much are people going to be charged? You do not pay the Government for a blood test to see whether you have picked up any other infection. The level of charging for PCR tests for people returning from abroad also remains a big issue. Last week in your Lordships’ House the noble Baroness, Lady Vere, told my noble friend Lady Ludford that PCR tests could be obtained at a price of £85 for two. My noble friend’s local pharmacy is charging £398 for a test on the same day, or £240 for the next day for two tests. I know other members of the public have reported similar problems. Can the Minister say how the pricing of PCR tests is being managed and, perhaps more importantly, where one can find the “£85 for two” tests?

On Tuesday, I set out what we from these Benches seek in a return to normal life. We want people to return to work as soon as possible, to be able to mix with family and friends and for our children to be able to have consistent access to education without interruption. We also agree that now is the time to start to do some of that but—and it is a big “but”—we cannot get rid of all the safeguards that protect people mixing together while the virus is still live. An effective test, trace and isolate system is essential. This Statement makes it clear that that is being dismantled. Can the Minister explain why that makes any sense?

Last night, Sebastian Payne of the Financial Times reported the re-election of Sir Graham Brady MP as chairman of the 1922 committee, and tweeted:

“Brady’s re-election is … a reminder of why Johnson is dropping masks and nearly all other … restrictions on July 19: ministers privately say the government no longer had the … votes to keep the measures in place. Relying on Labour would have been … difficult for the PM.”


Are the Prime Minister and the so-called Covid Recovery Group now putting health and lives at risk for their own principles?

Finally, with the threat of 100,000 cases by the end of the month, with hospitals saying they are already worried about the increase in patients and with the threat of the new lambda variant and new north-east variant under investigation, please will the Minister confirm that these changes are not irreversible and that the protection of the NHS, and the safety of all the people in this country, remain the Government’s priority?

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

My Lords, I am enormously thankful to the noble Baronesses, Lady Thornton and Lady Brinton, for such thoughtful questions. I will certainly try to address as many of them as I can.

In reply to the noble Baroness, Lady Thornton, on the advice we get, I am afraid, as I said last time, that we of course draw on lots of advice from lots of people. I completely acknowledge, as she rightly pointed out, that no decision in this pandemic is risk-free. She set out the list of possible risks very well. There is always the possibility that there will be new variants. We are extremely concerned about the existing 1 million people who have self-diagnosed with long-Covid symptoms; the possibility that that number may rise is very much on our minds, and we are putting in place NHS provision to assist in diagnosis and treatment of that.

We are extremely concerned that test and trace resources will be stretched. We are therefore looking extremely closely at the policy around testing and isolation, while providing test and trace with the resources it needs to get through any increase in the infection rate. I also completely acknowledge the concerns of the NHS Confederation on hospital beds and hospitalisations —although the statistics on those today are extremely encouraging.

Those are all acknowledged concerns that we keep close track of, while putting in place measures to mitigate and minimise their impact. However, the noble Baroness, Lady Thornton, half-answered her own question, because she is entirely right: we need to focus on getting the NHS back to speed in order to address the very long waiting lists and to get elective surgery back on track. It is very difficult to find an answer to the question, “If not now, when?” That has been tackled by the CMO and a great number of people. It must surely be right that we take the inevitable risks of restarting the economy and getting people back to their normal lives at the moment of minimum risk from the virus, which has to be in the middle of summer. Assessing those risks precisely is incredibly complex. Impact assessments of the kind that we would normally associate with legislation are the product of months of analysis. They often identify one relatively straightforward and simple policy measure. We are talking here about a machine of a great many moving parts.

I cannot guarantee that any model anywhere could give us accurate projections of the exact impact of what is going to happen this summer. We are, to a certain extent, walking into the unknown: the Prime Minister made that extremely clear in his Statement. As such, we are ready to change and tweak our policy wherever necessary in reaction to events. However, what we know very well now on the basis of our assessment of the data, and because of the pause we put in place to give ourselves breathing time to assess and additional time to roll out the vaccinations, is that that direct correlation between the infection rate and severe disease, hospitalisation and death has massively diminished. There is a relationship, but it is a fraction of what it used to be.

We can therefore look at a period where those who are at extremely low risk of any severe disease may see an increase in the infection rate, because we know that those in the highest-risk groups have been protected by two doses of the vaccine, and two weeks, and because we are working incredibly hard to get as many in the high-risk groups vaccinated as possible—half a million a day—and to roll out the vaccine to younger cohorts. That is the balance. I cannot deal in certainty here, because certainty does not exist. Balance is key, and I believe the balance we have here is the right one.

The noble Baroness asked specifically about the NHS Covid app. It is in some ways emblematic of the kind of decisions we are making at the moment. She is entirely right: the anecdotes are loud and clear. The app is pinging loudly around the country as the infection rate moves up. To clarify the legal point, as noble Lords probably know, the app protects privacy. We do not know the identity of the person who has the app. In fact, we have no information about people who have the app at all because it has such rigorous privacy protection. As such, the ping from the app is advisory but a telephone call from test and trace is mandatory. That has a legal status and a breach of that advice could lead to an FPN or a knock on the door. It has a different status in that respect.

Given the large number of infections and the large number of pings, we clearly need to review the way in which the app works. The Prime Minister talked about this earlier today. He talked about moving from a quarantine-and-isolation approach to more of a test-and-release approach. We are not quite there yet but we are clearly well on the way. Therefore, I would be glad to clarify how we have made those decisions once they have been announced.

The noble Baroness, Lady Brinton, talked about the plight of the immunosuppressed. I am grateful to her and to Anthony Nolan, Cancer UK and others who were on the call yesterday. I express complete sympathy with the point made by the noble Baroness. If you are at home and your immune system does not work as well as other people’s, and you see the rest of the country opening up, you will feel extremely uncomfortable, as though the world has moved on and that you have perhaps been left behind. Those were the feelings described to me by the experts I met yesterday. On an emotional level, I completely sympathise with that. There are some people in this country whose immune systems do not protect them from flu and contagious diseases that would have no impact on those with a fully functioning immune system. We have complete sympathy for those people.

I acknowledge the noble Baroness’s point that there is a need for clear advice because the immunosuppressed are a highly diverse group. There may be people recovering in hospital with a completely flatlined antibody system, compared to someone who has rheumatoid arthritis but is otherwise living at home and is mobile. It must be right that that communication is done on a tailored basis through the healthcare system. We will look at ways in which we can ensure that GPs are informed and have the right information in order to give that bespoke advice.

The dissonance is hard to bear. I recognise the noble Baroness’s point but I do not necessarily have a suite of answers for absolutely everyone in this condition. We have large investments in antivirals and in therapeutic drugs, including some of the monoclonal antibodies that may offer some protection to some people in this situation, but it is not going to be a blanket measure. As a result, we are putting a huge amount of investment in the OCTAVE study, which looks specifically at ways in which vaccines, boosters or therapeutics can be used to protect those whose immune systems are not right. Ultimately, it is going to be down to the vaccine. The vaccination of a large proportion of the population, including the carers who look after the immunosuppressed, is how we will offer protection to these people.

On the noble Baroness’ question about the LFT system being dismantled, I do not recognise those press reports. On the provision of PCRs by the private sector, she asked how prices are determined. The answer to that is through the market. The marketplace introduces competition and innovation. I am pleased to say that the price for tests is coming down and will come down further. The one provided by Chronomics for TUI is now £30; that is a very encouraging sign that there is more to go.

[The Deputy Speaker (Baroness Fookes) (Con)]

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. I call the noble Baroness, Lady Nicholson of Winterbourne.

[Baroness Nicholson of Winterbourne (Con)]

On behalf of the whole House and the whole population, I congratulate the Minister on his magnificent work during the entirety of the pandemic and, of course, all his colleagues and everyone in the National Health Service. It has truly been a real world-beater and we are all so grateful. I have a matching point on Covid-19. I had understood, maybe wrongly, that males are affected slightly differently to females. Given that hospitals now accept self-identification of males and females, does this impact on the statistics or indeed on the treatment that everyone receives?

[Lord Bethell (Con)]

My Lords, I understand the question put by my noble friend but I am afraid that I do not recognise the anecdote to which she refers in terms of hospitals’ treatment of individuals. Nor do I particularly recognise the generalisation that males and females are affected by the disease differently, but I would be very happy to look into this matter and write to her if I can find more details.

[Baroness Finlay of Llandaff (CB)]

I thank the Minister for his responses and for the meetings he has set up. Using his words, given the challenges of “getting the NHS back to speed”, as well as the predicted rise in seriously ill patients with infections— both from influenza and Covid variants such as beta, lambda and others that may emerge—what contingency plans are being developed and activated now? What is being done to increase bed capacity for the autumn and winter and to recruit, train and upskill staff who have currently stepped back from or retired from clinical care, to increase overall capacity?

[Lord Bethell (Con)]

My Lords, the noble Baroness is entirely right to make the connection between Covid and flu. We regard the winter as presenting two pandemics, and we will treat them with equal energy. Flu and Covid have the same net effect on the healthcare system, which is to be a huge drain on resources. So we are putting a huge amount of effort into the vaccine and boosters for Covid and the vaccination against flu. They can be taken together, and the advertising and promotion distribution to identify priority groups will be extremely energetic. That is the most important thing we can do to protect the NHS. Our second priority, though, is getting the beds to which the noble Baroness referred used for elective surgery. We do not want to see the NHS heaving under the pressure of Covid and flu. We want to see it addressing the backlog.

[Lord Winston (Lab) [V]]

My Lords, to return to my noble friend Lady Thornton’s first question, given the continued rise of the variant mutations and increasing infections, can the Minister report on a simple biological issue? What rapid mathematical calculations are in the Government’s possession to assess and predict the increasing risk of further new variants evolving that may escape the current vaccines or are more virulent? If he is unable to answer this question now, perhaps he will be kind enough to write to me.

[Lord Bethell (Con)]

My Lords, I cannot promise to have a simple algorithm to make the calculation that the noble Lord refers to. I will ask the system if such a thing exists, but I have never come across such a thing. The challenge he alludes to is entirely right: the vaccine pressure on the virus will create the circumstances in which variants are possible. That is why we are investing heavily in sequencing, not only here in the UK where everyone positive is now sequenced thoroughly and studied, but also offering that around the world through NVAP—the new variant assessment platform—to try to understand what is going on in markets around the world. To date, we think that we have tracked down all the current routes that the virus is taking, and we are satisfied that they are met by the vaccine, but we keep our eyes peeled.

[Lord Scriven (LD)]

My Lords, evidence shows that those in close contact with a positive case need to be traced with 48 hours to break the chain of transmission. Regardless, if close contacts have to self-isolate or self-test, how does stopping a mandatory requirement to register, either digitally or manually, on entering a venue such as a pub or restaurant help with the effective tracing of close contacts if no record exists of people in venues where positive cases are identified?

[Lord Bethell (Con)]

My Lords, the registration of people going into events is an onerous responsibility for the hospitality industry and we have to make a proportionate assessment of what kinds of burden we are putting on the economy and society. With more than 60% of the population now having been double vaccinated for over two weeks and with the vaccination programme going along at 500,000 a day, it is the moment to start backing off on some of these obligations. That means dismantling some of the infrastructure of test and trace, which we seek to do in a proportionate and logical fashion.

[Baroness Browning (Con) [V]]

Given the prediction of increased infectivity, what internal guidance is being given post 19 July within the NHS? Will GP surgeries, A&E and outpatient departments revert to their former practices, or is the guidance that they should retain face masks, distancing and hand gel use?

[Lord Bethell (Con)]

My Lords, on the three specific locations the noble Baroness asked about, I understand that those practices will remain in place, but I am happy to check that and write to her. As for going back to where we were before, I think some things will change for ever.

[Baroness Bull (CB)]

My Lords, 120 scientists have written to the Lancet and today come together in an emergency summit to ask the Government to rethink their plans. The editor in chief warned against

“a plan driven more by libertarian ideology than prudent interpretation of the data”

and called for continued mask-wearing, distancing and increased vaccine coverage. A YouGov survey found that two-thirds of people want to continue with masks and an ALVA survey found that three-quarters of people did. So why have the Government decided to end this simple yet effective measure? It costs the economy nothing, but it would be life-changing for the clinically extremely vulnerable, who will be forced back into lockdown by this shift from a public health approach to so-called personal responsibility.

--- Later in debate ---

[Lord Bethell (Con)]

I am always grateful for the challenge of medics in the Lancet and elsewhere. I would like to reassure them that this is not a question of libertarian ideology but a question of assessing the risks faced by the country. We have discussed masks several times in the Chamber. I would like to reassure the noble Baroness that masks simply are not a panacea; were the whole country to wear masks for the rest of their lives, we would still have pandemics because they offer only marginal protection.

[A noble Lord]

Nonsense!

[Lord Bethell (Con)]

I am afraid we cannot have in place laws on the intimate practicalities of people’s lives for the long term. We do not have a law on sneezing. I would not think of sneezing in the presence of noble Lords, but I do not accept that I should be given a fine for doing so.

[Lord Campbell-Savours (Lab) [V]]

My Lords, following calls from the BMA, the RCM and Cambridge University Hospitals, can we have an assurance that in every setting where health workers are caring for patients with suspected or confirmed coronavirus, the health worker will be wearing at least a close-fitting FFP3 mask, thereby maximising personal protection? Can we be assured that the wearing of regular masks in such conditions will not be permitted? Mask specification is critical in healthcare settings.

[Lord Bethell (Con)]

My Lords, the noble Lord’s expertise on mask specification is well known in the Chamber and I bow to his greater knowledge on this. Of course, healthcare workers, social care workers and anyone exposed to those known to be carrying coronavirus should have entirely appropriate and significant protection. I do not know the precise mask numbers, but I would be glad to write to the noble Lord to confirm the current guidelines.

[Lord Oates (LD)]

Is the Minister aware that the comments he just made about the effectiveness of masks are not just nonsense but dangerous nonsense? Will he withdraw them?

[Lord Bethell (Con)]

I do not accept that at all. The noble Lord does this debate no favours by using that kind of language. The argument I make is extremely reasonable. It is supported by the Chief Medical Officer and the other scientific advisers we have in government. I would like to ask the noble Lord to reflect on the manner of that question.

[Lord Bilimoria (CB) [V]]

My Lords, I was contacted by NHS Test and Trace and asked to self-isolate earlier this week. I am double jabbed, I have no symptoms, I have had Covid, I have been testing myself every day with lateral flow devices and I am negative every day. The CBI, of which I am president, is finding that many companies and businesses are complaining of losing employees. The NHS itself is complaining of losing staff because of self-isolation. Surely, we have to move as quickly as possible to a test and release system so that people can get on with work. Will the Minister confirm that lateral flow devices will continue to be made available free to businesses and citizens? If not, it will be penny wise and pound foolish.

[Lord Bethell (Con)]

My Lords, I am sympathetic to the noble Lord’s frustrations, but he is illustrating the delicacy of the inflection point we are currently at. Only 60% of people are in his fortunate position of having had two jabs for over two weeks. That is a huge reservoir of tens of millions of people who are unvaccinated. There is also a very large number of people—3.5 million in total—on the shielding list who have some kind of vulnerability. The noble Lord could be carrying the disease even though he has been double vaccinated. Of course I aspire to the destination the noble Lord described, but we cannot rush it. We are taking it in a proportionate and logical fashion, and we are absolutely keeping our eye on the kinds of down side risks the noble Baroness, Lady Thornton, described.

[Lord Balfe (Con)]

My Lords, I welcome the fact we are losing our obsession with Covid and learning to live with it. Earlier this week the Minister mentioned the NHS winter plan and said that it would be published. When will it be published and will there a be an arrangement for it to be debated and regularly reviewed so that we can see how we catch up with the huge backlog of health conditions that need dealing with?

[Lord Bethell (Con)]

I am grateful for my noble friend’s kind comments. On the NHS winter plan, he is right that I implied that it would be published. I have looked into this and my understanding now is that it is not a document due to be published imminently, as a winter plan was published in the autumn of last year. There are plans in place and I am working hard to try to provide my noble friend with whatever information I can.

[Baroness Donaghy (Lab)]

I asked the noble Lord on Tuesday what assessment the Government have made of Covid deaths and long Covid rates after the proposed 19 July changes. He did not answer. Will he do so now?

What incentive is there to uphold the test and trace system when a common interest between employer and employee is keeping their workplace open, particularly if sick pay is poor and self-isolation an unaffordable choice? If, as the noble Lord says, we do not know how many people use the app, how will we know if its use is dropping like a stone? What evidence will we have that it is becoming less effective?

[Lord Bethell (Con)]

My Lords, I did not quite say that I did not know how many people use the app; I said that we do not know who is using it. We keep an eye on it and, to date, its use has not dropped, but we are naturally concerned that trust in the app will deteriorate and that is why we are looking carefully at the advice that comes out of being pinged. Some 19 million people have the app. It is an enormously valuable resource, and one that we believe has made a big impact.

Predicting long Covid and infections is extremely difficult because we do not know what the infection rate is going to be. We are in a race against the virus. I hope that very soon the impact of the vaccine will bring R below one and the disease will start going down instead of up. But I cannot tell the noble Baroness, exactly when that date will be.

[Lord Robathan (Con)]

My Lords, last month the Minister made some highly critical comments about my having had the temerity to question the wisdom of government restrictions. Yet we now know that the last Secretary of State did not believe in their value either. Given the small risk to children and teachers from the virus, can my noble friend explain what the value has been—backed by evidence—of severely disrupting the education of hundreds of thousands of children by enforced isolation? Or should we be similarly sceptical about that policy?

[Lord Bethell (Con)]

My Lords, I know that my noble friend is sceptical of almost everything to do with the Government, and I am not quite sure how to address that question—but I will take it seriously. The bottom line is that children are a vector of infection, and, during the tough days before the vaccine, they were the ones who spread the disease around, accounting for a very large proportion of the numbers. As a father of four, I can tell you that it was extremely frustrating to have our children sent home, but, none the less, it was an important and impactful aspect of our fight against Covid.

[The Earl of Clancarty (CB)]

My Lords, at the press conference on Monday, the Prime Minister drew a distinction between crowded Tube trains and relatively empty carriages on trains, where he might choose not to wear a mask. The Health Secretary made exactly the same point on Tuesday’s “Today” programme. However, the Minister will be aware of the research showing that aerosols can hang in the air for many hours in enclosed spaces—which train carriages are. Despite what the Minister has just said about face masks, will that important factor be taken into account when a final decision is made about mask wearing on trains and other public transport?

[Lord Bethell (Con)]

The noble Lord will remember that, when we spoke about masks the day before yesterday, I re-emphasised my personal commitment to wearing masks. In no way do I want to leave noble Lords with the impression that I do not think that masks can play a role—I just do not think that we should be guilty of displacement and assume that masks will somehow solve all of our problems. The thing that will solve all our problems is the vaccine, and, when a larger proportion of the country is vaccinated, that will make an impact. But the noble Lord is entirely right: aerosols do hang in the air for a long time. You can breathe and cough into the air now, and someone can walk into that cloud minutes or even an hour later and catch the disease, as happened in the famous incident in Australia. We are very conscious of the point that the noble Lord makes, but a proportionate strategy on masks is reasonable.

[Lord Hain (Lab) [V]]

My Lords, I accept of course that the choices for Ministers such as the noble Lord are very difficult, but, with just half the population fully vaccinated, experts say that the 100,000 daily Covid cases predicted by the Secretary of State after he lifts restrictions could mean around 200 deaths daily. Is that an acceptable price to pay for living with the virus, when Professor Anthony Costello predicts a rampant third wave?

[Lord Bethell (Con)]

My Lords, the Secretary of State did not predict 100,000; he accepted that it was a possibility. I do not accept that we should welcome any deaths in any way. Our hope is that, in the race against the disease, the vaccine will win, R will be brought to below one, the spread of the disease in the UK will be brought under control and any third wave—there will be one of some kind—will be focused on the unvaccinated young, whom the disease largely passes straight through. That is what we are planning on, but we accept that there are risks; that is why we look at the situation daily, and we will change our policies if necessary.

[Baroness Uddin (Non-Afl)]

My Lords, I thank the noble Lord for the Statement. Given the warnings of millions of infections and millions suffering from the serious impact of long Covid, are we not opening up too soon without planning, as was well stated by my noble friend Lady Donaghy? Worryingly, we apparently do not have data on the numbers of infections and those with long Covid among those who have been fully vaccinated, as I have—why? Like others, my grandchildren are among the millions of children affected by many school absences, with many finding the regular testing extremely difficult. Is the Minister aware of Abu Dhabi’s Biogenix Labs’ non-invasive saliva testing, which is being used widely and effectively? Are the Government considering a rollout among our own school population? Finally, I add my voice to calls for the Government to publish an equality impact assessment, specifically with the differential effect on diverse and vulnerable communities.

[Lord Bethell (Con)]

I completely accept the question on whether we are moving too soon; it is a perfectly reasonable question. The counter suggestion is this. Say we waited until 85% of the population is double vaccinated, which would be in, say, October—would that necessarily be a better time to do this, when the NHS is at its most stretched and the winter conditions and cold encourage the spread of the virus? We have looked at it really carefully and, on the balance of risk, today is the right day to make these decisions.

On saliva testing, I pay tribute to those who are working here in the UK on the LAMP system, which we have prioritised with a huge amount of investment, particularly for those from special needs schools who find swab testing uncomfortable or really do not like to do it. We hope to report back but I am afraid to say that saliva testing has so far proved to be quite a difficult challenge, and it has not met all the tests that we would have liked it to have done.

[Lord Cormack (Con)]

My Lords, declaring an interest, I ask my noble friend to guarantee that all octogenarians will have a booster jab in the autumn? I apologise for returning to this, but can he guarantee, on the Floor of this House today, that all care workers in care homes will be obliged to be vaccinated no later than September?

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, we have a prioritisation list for the booster and the third jab. It is my understanding that octogenarians are in category 1, but I am happy to write to my noble friend to confirm that point, in case I have got that wrong. I share my noble friend’s aspiration on care home workers. We are in a consultation; I cannot make the guarantee that he asks for because it is an honest consultation. We have to take people with us: this is not something that we can impose on people against their will. When the consultation has passed, I am hopeful that we will be able to take the steps that he describes.

[Lord Rooker (Lab) [V]]

I congratulate the Minister on his track record of appearances in the House. I will raise two brief subjects with him, both of which have been raised today, neither of which he has addressed. First, are there plans to charge for the lateral flow test? It is now being delivered to people less than 24 hours after they request it, and requests will certainly go down if there is a charge. A clear answer on that would be useful. The second issue is shielding. When the Prime Minister makes a Statement on Monday, in advance of 19 July, it is crucial that something is said about people who were shielding before; they must not be left in limbo and ignored. They could at least be given a warning that they will be given, say, a week or 10 or 14 days before they need to shield, which would remove part of the worry from the large changes due to take place on 19 July. I ask the Minister to respond on lateral flow test charging and shielding, please.

[Lord Bethell (Con)]

My Lords, on lateral flow tests, I said that I did not recognise the press reports that the noble Baroness mentioned, and I still do not. On shielding, I completely agree with noble Lord. Some 1.5 million patients are identified as CEV-equivalent through the new QCovid model, and they have been added to the shielding patient list, with 820,000 who had not previously been invited as part of the JCVI cohorts 1 to 4 given priority access to vaccines. Overall, 3.8 million—I think I said 3.5 million earlier—individuals are on the shielded patient list, and we continue to maintain that through the NHS. We will look at the QCovid model and see if we can apply mix-and-match vaccines, booster shots and third shots to that model, and if we can bring together a new risk assessment for those who are vulnerable. That list could therefore be applied to any future shielding or protection that may be needed.

[Lord Mackenzie of Framwellgate (Non-Afl) [V]]

My Lords, I ask the noble Lord the Minister, in his usual courteous and helpful manner at the Dispatch Box, to provide answers to points raised yesterday with the Prime Minister in another place. In his usual way, the Prime Minister answered by asking yet another question, which of course earned another rebuke from the Speaker. If infections are allowed to rise, perhaps to 100,000 per day, how much are hospital admissions likely to increase and how many deaths may result? Why are the changes regarding isolation not taking effect until 16 August, with all the disruption to businesses in the interim?

[Lord Bethell (Con)]

The bottom line is that we believe that any rise in the infection rate will not have an impact on hospitalisation in a way that will disrupt the NHS. This is something that we have worked on with NHS colleagues, the clinical directors, the CMO’s office and the JBC, and we have taken into account a large variety of advice, including from SAGE. At the end of the day, it is our belief that, despite the rise of a third wave, hospitalisation rates will be manageable.

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

My Lords, following on from the question from the noble Lord, Lord Rooker, about the 3.8 million patients on the shielding list, will there be special provision for them to have antibody testing? Many of them may have had the vaccine but will not be sure whether it has been effective. Will there also be practical support for them? For example, if they do not feel that it is safe to go out, will there be help with shopping, special arrangements for medical appointments and other practical help?

[Lord Bethell (Con)]

We have committed to issuing guidelines for the vulnerable and immunosuppressed before 19 July. I cannot share with the noble Baroness at this stage exactly what those guidelines will say, but her points are very well made. We have not made a decision on antibody testing yet, but she raises an important point. We have a number of therapeutics and antivirals that may provide either prophylactic protection or support in the case of infection. Knowing whether somebody has antibodies before they go into the winter is one of the things that should really help to provide reassurance as well as important clinical data on how treatment might pan out. We are looking at the use of antibody tests for that reason.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, the Statement says that there are currently no plans to vaccinate the under-18s. Can the Minister indicate what the possible timeframe could be for reversing that decision and vaccinating that cohort, taking on board that around 0.5% of pregnancies are to girls aged under 18? Will he further elaborate on the fact that the Prime Minister indicated that there will be deaths—quite a large number—when we open up? What level of deaths do the Government consider acceptable?

[Lord Bethell (Con)]

My Lords, the vaccination of children is something that we are looking at; it is with the JCVI at the moment, I understand. I do not have the precise timetable at my fingers. What I will say is that we of course need to vaccinate as many adults as we can and will therefore move to children after that, because they are the ones who least need that protection. My nephew has been vaccinated in another country; I have spoken to him about it and it is very touching to hear him describe how he now feels that he can visit relatives who might be vulnerable or have co-morbidities. He sees it as a contribution to the national well-being. That is exactly the spirit in which we go into this but, as I say, it is up to the clinicians to make their pronouncement. We wait to hear from them before we can make a decision.

[The Deputy Speaker (Lord Faulkner of Worcester) (Lab)]

My Lords, all supplementary questions have been asked.