Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020

Lord Bethell Excerpts

Thursday 10th December 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020.

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

My Lords, these regulations will provide an agile and robust regulatory environment for Covid-19 test providers. This is essential to ensuring that everyone has access to simple, effective and high-quality testing services that they can count on.

The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020 will remove all CQC regulatory requirements for Covid-19 test services. Existing exemptions leave inconsistencies, resulting in some Covid-19 testing providers being within the scope of CQC regulation while other providers are exempt. We want to tidy this up. We will simplify the regulatory system for Covid-19 test providers, making it easier to understand for both suppliers and consumers.

The second SI is the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020, which will impose requirements on private test providers to become accredited by the United Kingdom Accreditation Service and to attain specific stages of a process towards this accreditation within a given timeframe, starting on 1 January 2021.

I will say a word on context. Last week, the Medicines and Healthcare products Regulatory Agency recommended authorising Pfizer/BioNTech’s Covid-19 vaccine. While we wait for the vaccine deployment, testing and contact tracing remains one of the most effective ways of controlling the virus. During this important period, the more rapidly we can identify people at risk of infection, the quicker we can get life back to normal. In the last nine months we have built the largest diagnostic network in British history, which is helping us to tackle the spread of the disease and create the long-term capability to ensure that we are prepared to tackle future pandemics. However, we will only defeat the virus if the public and private sectors work together. The private sector has a critical role to play and has shown this time and again throughout this pandemic. I thank those in the diagnostics, logistics, data and associated industries for their contribution to our pandemic response.

In addition, it is not right to look to the NHS to provide every test for every circumstance. Private sector testing can support NHS Test and Trace by offering tests to those who have a reasonable need for testing but are outside the conventional clinical or epidemiological use cases. It can also help to drive innovation. The Government are therefore supporting the development of a private testing market. We want to ensure that everyone has access to simple, effective, high-quality and affordable testing services that they can count on, whether from the Government or a private provider.

As the demand for testing continues to grow and the number of providers increases, we need to reassure the public that quality control is as important as ever. That is why we want to support private providers to ensure that they can enter the market in a timely manner and meet the demand now without compromising the quality of their testing service.

There is currently a requirement in England to register with the CQC if you are involved in the removal of bodily cells, tissues or fluid samples or the analysing and reporting of these samples for Covid-19 testing. This requirement is subject to a number of exemptions, depending on the type of Covid-19 test sampling and analysis and on the entity undertaking the sample collection. This has resulted in inconsistent requirements for test providers, which have been a source of confusion. Test providers have emphasised the complexities surrounding entering the Covid-19 testing market and we have listened to them.

The first statutory instrument that I have laid before your Lordships will remove the requirement for Covid-19 testing providers to register with the CQC by exempting Covid-19 testing as a regulated activity under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. As the CQC is an English regulatory body, this does not apply in the other nations of the UK. These requirements will be removed, preventing confusion over the scope of regulations from causing restrictions in total testing capacity. It is imperative that a quality service is provided and testing capacity is not restricted; the change from CQC to UKAS will create an agile and robust regulatory environment.

The United Kingdom Accreditation Service, known as UKAS, is the sole national accreditation body in the UK, independent of, but appointed by, the Government. Accreditation by UKAS is the recognised gold standard for organisations offering test services. Since the beginning of the pandemic, we have been working with UKAS to ensure that Covid-19 test providers can access advice on quality assurance and become accredited. It has taken time to ensure that we get this right. Recognising this, and the urgent need for high-quality private testing, on 27 November my department and UKAS launched an adapted three-stage UKAS accreditation process for private test providers, to ensure that new and innovative providers can be accredited faster, without compromising on rigorous safety standards.

The second instrument that I have laid before your Lordships will require all providers offering test services on the English market to complete stage 1 of the UKAS accreditation scheme and attain UKAS applicant status from 31 December. After 31 December, new entrants to the market will be required to achieve UKAS applicant status before offering test services on the English market. The instrument also requires providers to achieve stage 2 UKAS appraisal and stage 3 UKAS accreditation statuses. Providers will need to complete stage 2 UKAS appraisal by 31 January 2021 or, if entering the testing market after 31 December, by whichever is later of 31 January 2021 or four weeks after gaining applicant status. Providers will then need to complete stage 3 UKAS accreditation by 30 June 2021 or, if entering the testing market after 31 December, by whichever is later of 30 June 2021 or four months after gaining appraisal status. Providers will be prevented from offering test services if they fail to meet these requirements. We have engaged closely with providers to ensure that these timelines are achievable.

Stage 1 UKAS applicant status requires applicants to self-declare that they meet 10 minimum standards, set by clinicians. Having gained applicant status, stage 2 UKAS appraisal requires test providers to demonstrate that they are progressing towards accreditation. The last stage, stage 3 UKAS accredited status, requires applicants to achieve full accreditation. As a result of the legislation that I have laid before your Lordships, test providers that provide tests commercially will be required to undergo this staged accreditation process. Employers that provide test services only to their own staff and organisations that supply tests at no cost will not be required to gain UKAS accreditation, although I would advise that they do so to ensure that their test services meet the highest possible standards. From 15 December, international arrivals will be able to opt in to “test to release” and all test services used for this purpose will be required to be working towards full accreditation.

Before I set out my final justification for these SIs, I must thank the JCSI, which scrutinised them so quickly. I will explain how the tests for the presence of antibodies are covered by these regulations. Current forms of tests for antibodies are not covered by existing CQC legislation and will not be covered by the UKAS legislation. As such, these regulations do not leave any regulatory gap for testing for antibodies that did not already exist. However, providers of tests for the presence of antibodies to Covid-19 can choose to apply for accreditation if they wish to do so.

Fundamentally, the new UKAS scheme will simplify the process of looking for a commercial test. Consumers will be able to identify providers capable of delivering a quality end-to-end test service, giving individuals and businesses the assurance they need. We strongly advise that consumers and organisations procure test services only from the gold standard providers which are on their journey to UKAS accreditation. They will be clearly listed on GOV.UK.

The legislation that I have introduced will simplify the testing landscape for test providers and regulate the market consistently, protecting consumers and helping test providers. I am enormously supportive of employers who have already chosen to begin testing their staff, but it must be done properly, using the right tests for the right purposes. These regulations will help employers and individuals to identify the right test services for their purposes and will help test providers to enter the market.

Finally, I apologise for not being with your Lordships in the Grand Committee this afternoon. I have been asked to isolate because a member of my household has tested positive. I am extremely grateful for noble Lords’ forbearance in this matter. I beg to move.

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[Lord Bethell (Con) [V]]

I thank noble Lords enormously for an incredibly thoughtful discussion and I will seek to answer as many of their piercing and thoughtful questions as I can. If I miss any I will be pleased to write to noble Lords to clear up any loose ends. I will forgo the normal warm words at the beginning of such a speech and move directly to addressing the questions raised by noble Lords.

It is absolutely vital, as we open up our economy, that NHS supplies are saved for the situations where they are most needed. That is the principle behind what we are doing here today. To be clear: we are continuing to massively upgrade our commitment to testing. The PCR testing capacity for clinical and symptomatic testing is now reaching towards 800,000 a day—a colossal number—and the turnaround times have come down dramatically. In my household’s case, the test was taken at lunchtime yesterday and the result came at 7 am today—a phenomenal logistical achievement. We are also committed to the kind of community testing that the noble Baroness referred to, with the testing of asymptomatic individuals using technology such as the lateral flow devices that noble Lords will be aware of. This is exemplified by, but not limited to, the kind of testing in universities and schools that we have been piloting this autumn and will be rolling out in a very big way over Christmas.

As I have said before, we are investing massively in NHS testing, free at the point of use and available free of charge to all those who meet the use cases defined by the CMO. To ensure that this is possible, we need to enable the provision of new and innovative testing programmes that are as reliable and effective as possible. However, the NHS cannot possibly have pressure put on it to provide every test that every person in every part of this country wants at every time of the day. That has never been the case in this country and cannot be the case in the future. If tests are needed that are outside the use case or if someone is seeking to enable activities that fall outside the responsibility of our public health regime, it is right that those tests are sought from outside the NHS. It is therefore right that we seek to regulate the provision of those tests by the private sector.

The legislation that I have set out will ensure this, providing public confidence in testing and supporting private providers to enter the market. As I have set out, we need to create an agile regulatory environment for test providers, and we can do this by removing all CQC regulatory requirements for test providers, replacing them with the gold standard UKAS accreditation for commercial test providers. It is not our intention to cap the price, but it is our expectation that, given the billions of Covid tests now being manufactured around the world, the price will fall dramatically, and it is our intention to ensure that the quality meets clinical standards.

These measures will simplify the complex regulatory system for Covid-19 test providers; simplify the process around looking for a commercial test; and give individuals and employers essential assurances over the tests they procure. In response to the noble Lord, Lord Hunt, and my noble friend Lord Bourne, accreditation by the UKAS is the recognised gold standard for organisations that offer test services. My officials have worked really closely with colleagues at the UKAS to ensure that the accreditation scheme for Covid-19 test providers is as agile as necessary to deal with this growing market. The adapted three-stage approach is a direct result of this, ensuring that new and innovative providers can be accredited in a timely fashion, while preserving the UKAS gold standard. My officials will continue to work with the UKAS to ensure that this process is as seamless as possible, that test providers are given the support that they require to move through the scheme, and that correct enforcement procedures are in place.

Regarding contracting private industry to supply testing services, I hope that I will not shock either the noble Lord, Lord Hunt, or the noble Baroness, Lady Bennett, if I tell them that we are already engaged with the private sector in the purchasing of healthcare services for the NHS in the UK—not least in the provision of primary healthcare, which is conducted by the private sector in the form of GP practices, and through social care. That is also true in testing services. Time and again, throughout this pandemic, the private sector has shown that it has a critical role to play. While I note the comments of my noble friend Lady Wheatcroft, my experience of private-industry contractors has been largely positive; where there have been problems, we have to look at the whole partnership of government, universities, NHS and private industry for responsibility, not seek to scapegoat any particular party in this national collaboration. It is vital, as we look to open up our economy, that NHS Test and Trace supplies are focused where they are needed most. To ensure that this is possible, while utilising new testing innovations, the Government are supporting the development of the private testing market. To do this, we are bringing forward the regulations that I have laid before noble Lords today.

In response to the noble Lord, Lord Hunt, and to my noble friend Lady Altmann, I make it clear that the existing lengthy and costly on-boarding process is one reason for introducing this more agile system. The existing system is suited for major complex laboratories, many of which have been around for many years, and new entrants to the market are rare. We hope to have a more agile regime that will encourage innovation, but I will be glad to write to noble Lords with details of the intended costs.

My noble friend Lady Altmann is absolutely right to be concerned about fraud. She is right that there is a self-assessment at the beginning of the process, which is quicker and cheaper, to encourage new entrants and to avoid bottlenecks as this industry scales up. However, this is quickly augmented by a mandatory requirement to follow a rigorous on-boarding process with full administration. I am convinced that this will provide the necessary supervision of this industry, although I take her comments seriously and we will keep a careful eye on this threat. To answer my noble friend Lord Bourne, the test providers will be prevented from offering services if they do not have the right authorisations. If they break the rules, there are substantial—unlimited, I think —fines set by magistrates and applied to the company to ensure enforcement.

The legislation that I have introduced will simplify the regulatory landscape for test providers and regulate the market consistently. I thank Covid-19 test providers for their pivotal work at this time. We encourage the development of these sorts of test services in order to reduce pressure on the NHS and ensure that the test and trace programme can focus on situations where it is needed most; but it must be done properly, using the right tests, for the right price and the right purposes, and with the right enforcement regime. I beg to move.

Motion agreed.

Puberty-blocker Drugs

Lord Bethell Excerpts

Thursday 10th December 2020 Lords Chamber

[Lord Young of Norwood Green]

To ask Her Majesty’s Government what assessment they have made of the administration of puberty-blocker drugs to children under the age of 16.

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

My Lords, the Government are committed to providing the best possible care for children and young people accessing gender identity services. Earlier this year, the National Institute for Health and Care Excellence was asked by NHS England to undertake a thorough review of the latest clinical evidence on the use of puberty suppressants and cross-sex hormones. An independent group, under the chairmanship of Dr Hilary Cass, will make recommendations about the existing clinical policies based on this evidence.

[Lord Young of Norwood Green (Lab) [V]]

My Lords, I wish to make my position clear: I am opposed to all forms of transphobia and transgender discrimination, but this should not override the rights of women as defined in law. I welcome the Minister’s statement on the guidance and the research, and I am sure he agrees with me on the importance of the NHS guidance. Does he also recognise that this needs to be ported? What actions will the Government take to ensure that local services, such as CAMHS, are sufficiently resourced to provide psychological support to all children and young people with gender-related distress?

[Lord Bethell (Con) [V]]

My Lords, the noble Lord puts his point extremely well. I share his concern for those with trans or gender concerns of any kind. I reassure him that provision of gender identity services at all levels is an absolute priority for the NHS. In the recent court case, we have seen a clarification of the guidelines attributed to some of those services, but it in no way mitigates against or suggests a lack of commitment on the part of the NHS to such services.

[Baroness Nicholson of Winterbourne (Con)]

Will the Minister confirm that since no baby can be born in the wrong body and human sex cannot be changed post- birth, the extensive plastic surgery, castration, double mastectomies and concomitant lifetime of heavy unnatural drug use that follow the introduction of puberty blockers are not the right way to assist a troubled child to gain mental stability and a contented and healthy future?

--- Later in debate ---

[Lord Bethell (Con) [V]]

I reassure my noble friend that people with gender dysphoria cannot access gender reassignment surgery under the age of 18, so young people are not eligible for the type of procedure that she describes. Gender identity services are clinically led and focus on enabling the young person to choose the path which suits their needs. They support children to explore their feelings, recognising that there is not a one-size-fits-all approach. This seems an appropriate approach in the circumstances.

[Baroness Fox of Buckley (Non-Afl)]

My Lords, I warmly welcome the court ruling that children cannot consent to treatment to suspend puberty. Will the Minister join me in saluting the bravery of Keira Bell for taking this action and echo her message that being a tomboy or not liking stereotypically girly things does not make girls or young women any less female? Crucially, will he clarify that this ruling does not undermine the 1985 Gillick judgment giving young women the legal right to reproductive healthcare without parental consent and that the false and scaremongering misinformation circulated by certain organisations, including Amnesty International and Mermaids, is driven by a particular agenda rather than a concern for trans- gender people’s rights?

[Lord Bethell (Con) [V]]

My Lords, I salute the court’s thoughtful and lengthy judgment, which brought enormous clarity to an area which is very important but which has also caused concern and ambiguity. The court has made it clear that children under a certain age are not ordinarily able to make the kind of decisions that have previously been asked of them, but there are openings. No one under the age of 16 can now be referred on to puberty blockers unless a court rules that it is in the child’s best interest. These are helpful clarifications and we look forward to further work to clarify this area.

[Baroness Wheeler (Lab)]

My Lords, the mental health and well-being of young children and teenagers who present with gender dysphoria are paramount. Given the NHS England announcement on puberty blockers, what support are the Government giving to children and teenagers affected by the revised guidelines and their families and schools? On medical matters, will a young person under 16 concerned about gender dysphoria who approaches a GP continue to be covered by the duty of doctor-patient confidentiality?

[Lord Bethell (Con) [V]]

I reassure the noble Baroness that patient-doctor confidentiality remains paramount and is respected. To update her, the Tavistock has immediately suspended new referrals for puberty blockers and cross-sex hormones for under-16s. In future, they will be permitted only where a court specifically authorises it. I reassure the noble Baroness that those already on the programme will continue their medication until the review has been finalised.

[Baroness Barker (LD)]

The legal team that brought the recent case has, over recent years, brought several cases designed to oppose LGBT rights and to restrict the reproductive rights of women and girls. All those actions are consistent with campaigns run by organisations including the Heritage Foundation and the Alliance Defending Freedom—extreme evangelical right-wing American organisations. Will the Minister tell the House which NHS England boards and committees approved the amendment of the gender identity service specification on 1 December, prior to the court requiring them to do so, and in the light of the fact that this judgment can and will be appealed? If he does not have that information now, will he write to me?

[Lord Bethell (Con) [V]]

Well, my Lords, it is not appropriate for me to comment on those who have brought these cases, and outstanding judicial proceedings exist and are in place at the moment, so it is not possible for me to comment from the Dispatch Box in response to the noble Baroness’s remarks. All I can say is that the NHS, NICE and the Tavistock all have the interests of patients at their heart; we are not ideological about that. We are absolutely committed to the best interests of patients, and I would be glad to write to the noble Baroness to answer in any way that I can the questions she asked.

[Baroness Gale (Lab) [V]]

Is the Minister aware that the ruling and the NHS England response to it have caused significant uncertainty and distress among young people and families currently supported by the Tavistock clinic and those on its waiting list? Can the Minister say what steps the Government are taking to ensure continuation of care for young people currently in the care of the Tavistock who are affected by the NHS England response to the court ruling?

[Lord Bethell (Con) [V]]

I am sure that the noble Baroness’s testimony is entirely right, and it concerns me that anyone has any concerns in this matter. I reassure her that the Tavistock is doing absolutely all it can to reassure current patients and those who are on the referral list; its communications have been excellent throughout. The provision of puberty-blocker services to existing patients has continued, and it will remain in close contact with those patients as the review plays out.

[Lord Dobbs (Con) [V]]

My Lords, I hope this is an appropriate moment to reflect on the life of Jan Morris, that glorious writer who died just over two weeks ago. She was born a man, served in the British Army, fathered four children with her beloved wife Elizabeth and then transitioned from male to female in the 1970s—a challenge she bore with extraordinary humour and patience. So perhaps I may recommend that my noble friend reads all her books in his spare time. Would he agree that Jan Morris’s example of seeing the world in glorious colours, rather than narrowly in black and white, and of always showing kindness and tolerance even to those who disagreed with, and perhaps disapproved of, her, is an example that should inspire all sides of this debate and give comfort to those, in particular children and their parents, who find themselves struggling with the same difficult situation she did?

[Lord Bethell (Con) [V]]

[Inaudible]—to be more affected by their warmth and kindness. Jan was an absolute model of warmth and kindness. Having worked in the nightclub industry, I have met, worked with and enjoyed the company of many trans people, which has always proved to be an extremely uplifting experience. I am a massive supporter of the trans movement in the round.

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

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

Covid-19 Vaccine Rollout

Lord Bethell Excerpts

Wednesday 9th December 2020 Lords Chamber

[Baroness Thornton (Lab) [V]]

My Lords, I thank the Minister for the update today, and for the all-Peer Zoom this morning. Yesterday was indeed a happy day. Like many—including, it has to be said, the Secretary of State—I was very moved watching 90 year-old Margaret Keenan get her jab. However, the challenges of the next period are as acute as, if different from, those of the period we have been through. What is the timeline for the vaccine for people who are housebound or shielded and cannot attend a surgery, whether in a hospital or anywhere else? It seems that the easy distribution of the vaccine will depend on the new vaccines coming down the track: communications will be vital. So what communications will people receive, from whom? Will that be centrally controlled or will it be done locally—through primary care networks, for example?

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

My Lords, the JCVI has laid out a clear prioritisation, putting great emphasis on those who are older—the over-80s—and those in social care. The vaccine will come to those who are shielded and living alone in due time. There are some practical issues with getting the current Pfizer vaccine: as the noble Baroness undoubtedly knows, it has to be kept in cold storage and comes in substantial batches, which are difficult to break up. The initial cohort consists of 6 million people—those over 80, and the health and social care workers who support them. As for future vaccines, those looking forward to being vaccinated should wait for a letter. Those letters are being organised through their doctors, who have access to a central database to ensure that the right prioritisation takes place.

[Baroness Jolly (LD) [V]]

I thank the Minister for the update, and join others in celebrating the good news about the first vaccines, administered yesterday. There are several different vaccines in the pipeline. Can the Minister update us on where they all are in terms of MHRA approval, and therefore of uptake? How many doses will be available, and by when?

[Lord Bethell (Con)]

My Lords, the precise status of each vaccine in the pipeline is a subject for dialogue between the vaccine manufacturers and the MHRA. I can tell the noble Baroness that we are extremely encouraged by the substantial number of vaccines in the pipeline. The safety data for all those for which we know the response is also extremely encouraging. AstraZeneca—the one that most eyes are on—is making good progress, but I am afraid that I cannot give a clear or confirmed time for when, or if, it will be authorised. As for doses, as the noble Baroness probably knows, we have committed to more than 320 million doses overall. The precise details of those are published on the Vaccine Taskforce website, and I would be glad to send her a link to that, so that she can get all the details.

[Lord Bates (Con)]

I thank my noble friend for this very good news, and for his tireless work in keeping us informed. Throughout this crisis, we have been given an object lesson in who are truly the key workers in our society, such as those working on farms and in supermarkets, and those servicing utilities, cleaning streets, organising deliveries and keeping us safe. Will he ensure that this lesson is remembered when ordering the front of the queue for the rollout of the vaccine?

[Lord Bethell (Con)]

I am grateful to my noble friend for his kind comments, and endorse his tribute to all those who have worked hard on the front line of healthcare during this pandemic, at times putting themselves at risk, and all of them under great stress. We owe them enormous gratitude. The JCVI has made a clear priority list and advised that the first priorities for any vaccination programme should be the prevention of mortality and protection of healthcare staff and systems. Therefore the vaccine is being rolled out to the priority groups, including care home residents and staff, people over 80, and healthcare workers. They are the ones who will be at the top of the list, and that seems to me proportionate, fair and right. As we work through the later prioritisations, others in the population will have access to the vaccine.

[Lord Bilimoria (CB) [V]]

My Lords, many congratulations to the Minister, the Government, Kate Bingham and the Vaccine Taskforce on V-day, yesterday. Does the Minister agree that this has been possible only because of the collaboration, in just six months, between the private sector, the Government, the NHS, universities, including Oxford, and the pharmaceutical sector, including AstraZeneca? In due course, could business help to roll out the vaccines, through inoculations taking place in offices, factories and business premises, thus causing less disruption? The CBI, of which I am president, stands by, ready to help.

[Lord Bethell (Con)]

I am enormously grateful to the noble Lord for his clear and heartfelt offer of help, and I completely endorse his comments. The collaboration between the NHS, the Government and business has been at the heart of our entire response to the pandemic. This collaboration has been termed the “triple helix”—a phrase that I like very much indeed. It is going to be at the heart of our building back of the healthcare system in the years ahead. On the noble Lord’s kind offer, I remind him that when someone takes any medical treatment, including a vaccine, they have to have the space to take stock and recover from the excitement of the vaccine, and they have to be supervised in that space by someone with some kind of clinical experience. So, while his offer is kind, it is likely that vaccine distribution will be in locations where we can put clinical supervision.

[Baroness Blackstone (Ind Lab)]

My Lords, do the Government intend to create some kind of vaccination passport, which will allow people to attend events across the UK and to travel to and from the UK without quarantine, if they have been vaccinated?

[Lord Bethell (Con)]

My Lords, the noble Baroness raises an extremely intriguing prospect. If it is indeed the case that those who have been vaccinated are not themselves contagious and cannot transmit the disease, there is the possibility that the vaccination will enable them to do things that might not be open to other members of the public. However, it is too early to call that one. We do not have the scientific evidence to demonstrate that the vaccine stops any infectiousness. We are working hard to try to understand that better. If it can be proved, we will look at an enable strategy.

[Lord McLoughlin (Con)]

My Lords, there have been many bleak days since the early part of this year, but yesterday was a day in which we can take great pride in the MHRA and all the people who were involved in bringing this vaccine quickly to the public in this country—the first in the world. In the past, a lot of criticism has been made of Kate Bingham. She has done a remarkable job in the way she has helped secure these vaccines from across the world. Will the Government be sure to learn the lessons of involving both private and public sectors in this remarkable venture?

[Lord Bethell (Con)]

My Lords, I join my noble friend in paying tribute to the MHRA. We have all seen Dr June Raine in her flawless presentation and authoritative explanation of the authorisation of the vaccine. I am sure that, if she were here today, she would want to pay tribute to her incredibly impressive team at the MHRA. I also pay tribute to Kate Bingham and the very many people from the private sector who have stepped forward during the pandemic to take on onerous, sometimes high-profile and sometimes quite controversial roles in the battle with the pandemic. We owe them a huge tribute. They have often given up their time and put themselves in the firing line in order to do this work. Kate Bingham has massively delivered for this country and I am grateful to all those, either at the top of the task force or in local community work, who have stepped forward and made a contribution to our battle against Covid.

[Lord Foulkes of Cumnock (Lab Co-op)]

My Lords, does the Minister agree that there is a danger that this whole programme could be undermined by crazy anti-vaxxers, particularly on social media? What are the Government going to do to counteract this?

[Lord Bethell (Con)]

The noble Lord speaks truth, as always, in this matter. We are naturally concerned by those who deliberately seek to undermine the integrity of the vaccine. However, we are also considerate of those who might have quite reasonable questions about it or might even have what we think are completely unreasonable ones but who have concerns about, or an emotional response to, vaccines. Our approach is to handle those doubts and questions in a dialogue and a spirit of partnership, trying to answer them as considerately as we possibly can. Yes, we should battle those who seek to profit commercially or are acting in their own narrow, national interest to undermine the vaccine in this country. But we want to answer those in our community who have questions about the vaccine with transparency, reassurance and science.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

My Lords, the time allowed for this question has now elapsed. We will pause for a minute before the next item of business.

Coronavirus Vaccine

Lord Bethell Excerpts

Thursday 3rd December 2020 Lords Chamber

[Baroness Jolly (LD) [V]]

No one can deny that the news about the Pfizer-BioNTech vaccine is just what we need as the days get shorter and Christmas still seems some way off. The technical achievement is enormous, and I am happy to congratulate all those involved in the creation of the vaccine, in the lightning regulation process and in its manufacture. The logistical challenge is next, and I feel sure that, again, the armed services will figure highly here.

Some time ago, I asked the Minister who might carry out the vaccinations. There are not enough NHS staff free to do it. Is there a plan to train others? The training is very short and needs no clinical background whatever. I seem to remember that student friends, when training to be doctors, would practise their technique by injecting oranges. I understand that it will be at least Easter before all the population has received the first round of the Pfizer vaccine and midsummer before we have all had the two jabs.

Can the Minister clarify what sort of immunity someone would have if they failed to get the second jab? What is the timescale of the availability of the other vaccines that we know are in the pipeline? When do we expect all the population of the UK who are willing to be vaccinated to have received their vaccine, and does he have an indication of how many will refuse it?

Vaccine is not a magic bullet—yet. Those of us who will not get it for some time will have to be careful and adhere to the rules outlined by the Government. We might be surprised that not everyone is aware of the symptoms of the virus—the cough and the loss of taste and smell, along with flu-like symptoms. They have not been part of the messaging but, on prevention, we all know “hands, face, space”. Was there a reason that the messaging did not include symptoms? I appreciate that if you are an avid follower of the PM’s No. 10 virus briefings, all that information is at your fingertips, but for many these are not required viewing. How much is the department using Instagram, Facebook and Twitter to get these messages out? If it is not using them, why not? For months to come, people will be testing positive, and anyone who does will still be required to quarantine.

I would like to spend the rest of my time addressing some issues relating to self-isolation that have come from research by King’s College London, based on surveys carried out by the Department of Health and Social Care. Many of us who have been in this situation isolate, as that is doing our bit to prevent the spread of the virus. King’s found that intentions to isolate were high but, when it came to sticking to it, the numbers were low. It found that there were both practical and psychological barriers to an effective isolation system. Practically, there is the issue of finance. The evidence suggests that those of a lower socioeconomic status with dependent children or older relatives struggle financially or lose their pay if they self-isolate, and they choose to ignore the advice.

The £500 grant has not been available since the onset of the lockdowns, and £250 does not cover all the costs for a family for a week if you lose your wage. If a child has to go into quarantine, there is no eligibility for support, yet in all probability a parent will have to take time off work to care for the child. Not all employers continue paying a salary to those isolating or caring for someone who is isolating.

The data that I referred to came from a series of surveys carried out by the department. Is that data in the public domain? It would be really interesting to see the breakdown by geography and demography.

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

My Lords, I am enormously grateful for that large number of thoughtful and nuanced questions, and I will try to cover as much ground as I possibly can.

I start by supporting the noble Baronesses’ tribute to the MHRA. It has played a complete blinder. It has quietly worked since January for this very moment. It has thrown an enormous amount of expertise, diligence and professionalism at the extremely challenging task of managing this vaccine authorisation, and it is to its massive credit that it has landed with an enormous amount of confidence and has been greeted so well.

The noble Baroness, Lady Wheeler, asked about EU law and exactly where we stand in terms of Brexit. She is exactly right that this authorisation was done under the terms of European law, and the carve-out that we took was indeed completely within the realms of European law. I pay tribute to the international collaboration that lay behind this vaccine—among the inventors, with their Turkish-German background, with the contributions of the German company that founded the vaccine and of the Americans, who have marketed and distributed it. In fact, the collaboration behind it has been global.

However, there is something British about it as well. In Britain, we have a long-standing commitment to research into infectious diseases, and that has created an enormously strong framework and foundation for the work that we have done. At universities such as Oxford, where the Jenner Institute is based, and Imperial, we have established a terrific international reputation for our work on infectious diseases.

The regulator, the MHRA, has gone about its work with an enormous amount of confidence and expertise. That has meant that it has been able to handle, in parallel, the clinical trials for efficacy and the reviews for safety. It analysed huge amounts of data in parallel in real time, so that it could turn around the authorisation promptly and confidently when presented with the final data.

The commercial effectiveness of the Vaccine Taskforce has been phenomenal. It has secured contracts for a large number of vaccines, which has meant that manufacturing has been able to take place in advance, and delivery of the vaccine, which is happening as we speak, is able to take place promptly. On the enormous amount of collaboration on the deployment of the vaccine, about which the noble Baroness asked, I pay tribute to colleagues in the NHS, NHSD, the military, and those in social care and logistics. There has been enormous collaboration across the piece.

The noble Baroness asked exactly what figures there are for delivery and when it is scheduled to take place. I am afraid that I cannot give the precise schedule, but I reassure her that, as soon as we know the precise timetable, we will publish it to give the confidence and reassurance to the public that, quite reasonably, they would like.

The noble Baroness is entirely right that social care is our number one priority. The prioritisation list from the JCVI is crystal clear. It also presents a big challenge because, as she knows, the Pfizer vaccine requires cold storage. It comes in units of more than 100 vials. We do not want to waste this extremely valuable vaccine, so we are having to work closely with social care colleagues and the NHS to ensure that workers and those in social care can receive it. That will be difficult, and I do not doubt that there will be problems, particularly, as the noble Baroness pointed out, with getting the vaccine to small units of social care. However, I reassure her that colleagues are working on that night and day and are very focused on delivering a solution.

The noble Baroness asked whether those who take the vaccine will need to isolate. Yes, they will, and that will have to continue for a while. The truth is that we do not know whether taking the vaccine will reduce transmissibility. Our suspicion is that it will, but until we have the clinical evidence that that is the case, we have to be pragmatic and ensure the safety of the public. However, we are working extremely hard on trying to resolve that issue, and I reassure the noble Baroness, care home managers and those who live and work in social care that they are at the top of the priority list.

The noble Baroness also asked me about delivery of the vaccine from Belgium. I reassure her that there are numerous fallback plans for all kinds of scenarios and that the transport arrangements for this valuable cargo have been thought through incredibly carefully.

The intention is not to roll out mass testing or community testing in every single local authority before Christmas. We are working with those local authorities that have stepped forward and that either are the most keen or have the highest infection rates, to ensure that the partnerships that we have in place develop really good best practice and that those directors of public health who are the most energetic have the resources they need to develop new models. That work is happening at pace and we get updates on it every day. It promises to be an extremely effective model for cutting the chain of transmission.

I pay particular tribute to universities, which have worked extremely closely with both the Department for Education and the department of health to ensure that there is community testing on campus, so that the migration home before Christmas is done safely and effectively.

The noble Baroness, Lady Jolly, is entirely right that apparently it is not very difficult to learn how to give an injection. I have been offered a training course, but I am not sure that anyone would actually want an injection from me. However, I reassure her that we have mobilised an enormous army of people to administer the vaccine. That includes those existing in the NHS and social care as well as pharmacists, who have stepped up massively and to whom we are very grateful, and it will include the return to service of many retired healthcare professionals, to whom we are enormously grateful.

As the noble Baroness pointed out, there is a pipeline of vaccines coming through, not least the British one developed at Oxford University in collaboration with AstraZeneca. I cannot give her a schedule on precisely when all of those will be delivered, but it is extremely promising that there are between half a dozen and a dozen vaccines on their way. It serves as an indication of how science has ridden to the rescue to help us out of this awful pandemic.

Regarding those who are either sceptical or refusing a vaccine, we are reassured that concerns about the vaccine are at present relatively low. We are engaging with anyone who has a concern about the vaccine with respect and in a spirit of dialogue to try to present the evidence in a transparent and reassuring way. That approach seems to have paid dividends, and I am encouraged that the British public will be stepping forward for the vaccine in very large numbers.

I reassure the noble Baroness that we have a massive social media campaign to engage the public. I pay tribute to the media teams in the department and the Cabinet Office, who have worked incredibly hard throughout the entire pandemic and have handled literally dozens of campaigns, often at pace, with enormous creativity and diligence—and have got sign-off from Ministers, which is no mean feat at times—under difficult circumstances. They deserve all our thanks and praise.

Lastly, on the noble Baroness’s quite important questions about isolation, she is absolutely right: isolation is key. There is no point in testing and tracing if you do not isolate. However, the surveys that she refers to are fragmented. I am not sure if some of the simple surveys actually tell the whole truth. In honesty, people’s response to isolation is probably more subtle than simple binary questions would suggest. We are beginning to understand that many who are isolating, although they may not have completely obeyed every strict command in the isolation protocols, have massively changed their behaviours, and we are looking at ways of supporting those people through civic and financial support and through our messaging to ensure that the isolation protocols are as effective as possible.

--- Later in debate ---

[Lord Patel (CB) [V]]

My Lords, as we embark on a mass vaccination programme, it is important that we follow up all those who are vaccinated, or at least a cohort of them, with whatever vaccines are used, in a scientific way. It is important that structured scientific data collection is implemented. Do the Government plan to do that, and who will be doing it? I hope that it will be UK academic institutions, because there is much more science to learn post vaccination about the effectiveness of different vaccines and the science of the new way of developing these vaccines.

[Lord Bethell (Con)]

As ever, the noble Lord is extremely wise in his observation. He is entirely right to hold us to account. There is no point in enjoying this fine moment too much when you have the noble Lord, Lord Patel, on your case reminding you about the next big challenge around the corner. He is right that pharmacovigilance is essential. We need to make sure that this and other vaccines work and that we learn from the behaviours of all of them. That is precisely why we put the deployment of this vaccine through the NHS. There was a temptation to set up an alternative agency and focus on the actual injection of the vaccine over all other matters. Instead we have run it through the NHS digital process, which means that all the information around the vaccine is put very firmly into the GP record. That means that we can do population-wide analysis of the results of the vaccine. We have a very large research community in the UK both in the companies such as Pfizer, which, as he knows, are responsible for pharmacovigilance, and in the university sector. We will have all those records available for them to do the follow-up work that he rightly emphasises.

[Lord Dobbs (Con) [V]]

My noble friend will know that I have reservations about some aspects of government policy, but the news about the vaccine is wholly good news. It is a triumph for all concerned and I join in with his praise for them, although my noble friend himself should not be shy about taking his own share of the credit. He mentioned that other vaccines are coming down the road—in the pipeline, I think he said—including the Oxford vaccine. These vaccines have different characteristics and require different handling. How do the Government plan to distribute and discriminate between the different vaccines? Will one get priority over another? While I understand that he cannot be precise, can he offer any further guidance about how soon we can hope that everyone who wants one will have a vaccination available?

[Lord Bethell (Con)]

I thank my noble friend for his kind words. I reassure him that everyone in Britain who wants a vaccine will get one. In fact, we are going to do everything that we can to encourage everyone in Britain to have a vaccine. We believe that prevention is better than cure, and that vaccines such as the ones coming down the pipeline offer the best possible fightback against this horrible disease. With regard to the different properties of the vaccine, his observation is entirely right: it is likely that the different vaccines have different properties, not least that some are much easier to transport than others, but some might work better, for example, with children or with those susceptible to other conditions. We do not have full data on the other vaccines so it is impossible to make those comparisons at this stage, but I assure him that when we have the data we will make sensible decisions along those lines.

[Lord Clark of Windermere (Lab) [V]]

I thank the Minister for being so frank and admitting that the initial rollout will not be uniform throughout the country this year. I want to ask him about those individuals prioritised for the vaccine on the grounds of age or having weaker immune systems—specifically, who will identify those individuals? Initially the role of GP surgeries was highlighted for that task. Is that still the case? What will happen in those GP surgeries—there are quite a number of them—that have no GPs? Will the nurse practitioners be able to perform the role of identifying those individuals? I would like a specific answer to that because it is important in the longer term for a great many people.

[The Deputy Speaker (Baroness Garden of Frognal) (LD)]

I remind noble Lords of the request for brevity.

[Lord Bethell (Con)]

I remind the noble Lord that the criteria sent out by the JCVI is extremely simple and mainly driven by age, so the selection procedure is very straightforward. He is right that the distribution of the vaccine is limited by both the size of the vials and the need for cold storage. That is why there will be an emphasis on hospitals over GP surgeries. That represents a challenge in places such as rural areas that may be distant from hospitals, but I reassure him that the deployment team is doing all that it can to ensure that no one is left behind.

[Baroness Brinton (LD) [V]]

Does the Minister agree with the JCVI’s decision not to prioritise unpaid carers—most of whom are caring for clinically, or extremely clinically, vulnerable people—when unpaid carers are not just prioritised but encouraged and chased by the NHS to have the flu vaccine in order to help protect the person they are caring for?

[Lord Bethell (Con)]

My Lords, difficult decisions have to be made by everyone in this. The JCVI has looked very carefully indeed at the challenge of how to prioritise this vaccine, taking representations from a large number of groups. Ultimately, its priority is to protect life and the NHS, and its clear decision has been to have a prioritisation based on age because this is the greatest driver of mortality.

[Baroness McIntosh of Pickering (Con) [V]]

My Lords, I add my congratulations to my noble friend, the MHRA and everyone associated with producing this vaccine in such record time; it is a great tribute to our health service. I will focus on the fact that the flu jabs for the over-50s are still being distributed, and there is a reluctance among some—perhaps as many as two-thirds of the over-50s—to take up the flu vaccine, as they would like to wait for the Covid vaccine, which, of course, defeats the purpose of offering them the flu vaccine. Is this something that my noble friend is aware of, and is it something that he could address? I echo the remarks of the noble Lord, Lord Clark, and ask that specific regard be had to the challenges of administering the vaccine in rural areas. Will my noble friend use, as far as possible, the dispensing doctors in this regard? I pay tribute to them and the work I do with them.

[Lord Bethell (Con)]

My Lords, as few will be surprised to know, the rollout of the flu vaccine has been hugely successful this year; the take-up has been massive. I am not aware, from the stats that I have seen, of any slowdown in the take-up of the flu vaccine, but the point my noble friend Lady McIntosh makes is understandable—I am happy to check it out. I also encourage anyone who is thinking about deferring the flu vaccine until they get the Covid vaccine to think again because it is a massive priority to get vaccinated for both.

The noble Baroness and I have talked before about dispensing doctors, whose role is very important. There is a challenge with the distribution of the Pfizer vaccine because of cold storage and the large number of shots in each vial. I am not sure whether that means that rural dispensing doctors can play the important role that they might do at this stage of the distribution, but I reassure the noble Baroness that they will play a role in the national distribution as it pans out over the next few months.

[Viscount Waverley (CB) [V]]

My Lords, I note that many unknowns exist in differing vaccine effectiveness cycles. Are the Government planning to combine the careful management of linking certified testing to identity data, particularly given that the technologies and solutions are available? As regards the urgent rollout of vaccines globally, I propose that a commandeering exercise of wide-bodied aircraft, laid-up due to Covid, be considered to lessen the global logistical nightmare.

[Lord Bethell (Con)]

My Lords, in relation to the logistical nightmare, one of the nice things about vaccines is that they do not take up much space: they are relatively compact, so I am not sure that wide-bodied aircraft will be needed, but I thank the noble Viscount for the wise suggestion. In relation to certification, he raises an interesting prospect that we have not fully bottomed out yet. As I said in response to earlier questions, we do not know whether vaccination will reduce transmissibility. Our hope and expectation are that it will, but until that is proven, any thoughts of certification will be premature.

[Lord Liddle (Lab) [V]]

I congratulate the Minister on his generous attribution of credit for this remarkable achievement, which was in very sharp contrast to the two Cabinet Ministers who sought to make cheap and inaccurate nationalist points about it yesterday—that is to his credit. Speaking as a Cumbria county councillor, I say again that his honesty about the constraints on the rollout is commendable, and I ask whether he agrees that, in rural areas, it is still very important that we concentrate on remedying the defects in our tracking and tracing system that our Cumbria public health director has identified? There is still a lack of proper liaison between the national and local systems, and this deficiency has to be addressed in this period, as people may become more relaxed as a result of the wider availability of a vaccine.

[Lord Bethell (Con)]

I welcome the noble Lord’s challenge and completely endorse his point that tracing will remain important. Not everyone will take the vaccine initially; it will not be available to everyone for months, as the Deputy Chief Medical Officer made plain in his briefing earlier today. Tracing remains a really important feature of our fight against this disease. However, I respectfully suggest that his information is a little out of date: the amount of collaboration on tracing between the national and local efforts, particularly with DPHs such as the one in Cumbria, has come on in leaps and bounds, even in the last few weeks. From my briefings and meetings with DPHs, I know that they have been provided with an enormous amount of data, support and access to tracing resources in order both to bring their local intelligence and insight to bear and to support the national tracing effort. I applaud all those DPHs who have stepped forward in this way, and I am very hopeful that the local-national combination on tracing will pay massive dividends.

[Lord Scriven (LD) [V]]

My Lords, in the first priority group, there are over 3.2 million people aged 80 or over. As the UK will get doses for 400,000 people initially, what access framework is in place to ensure an ethical approach to the vaccine rollout for these first 400,000 people that is not based on having the sharpest elbows or the chance of having a hospital appointment?

[Lord Bethell (Con)]

My Lords, the noble Lord raises an important challenge there; fairness and equity are important in this important time. However, I will try to assess the situation: we have 800,000 doses of a vaccine that is incredibly difficult to transport, requires cold storage and is in vials containing more than 100 doses each. Therefore, practical considerations are pre-eminent at the moment, rather than sharp elbows.

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

My Lords, I thank the Minister for the gracious way he has introduced this discussion, and I welcome his assurance of dialogue. I hope he will agree, as he has assured us, that the vaccine will not be the only effective means of preventing infections and further deaths and that the Government will continue their heartening improvement of the test and trace programmes and ensure that those in tiers 2 and 3 have the required financial measures. Can he assure me and the House that his department will urgently scale up communication with particularly vulnerable and poorer communities, where concerns around vaccination are significant? Can he assure me that any proposed government use of the police and army will be done with consent and after consultation with local authority leadership?

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[Lord Bethell (Con)]

The noble Baroness will probably have noticed earlier today the recent publication of test and trace figures, which showed a dramatic improvement in both the tracing numbers and the testing turnaround numbers. We still have far to go, and improvements are needed, but this is an extremely encouraging set of figures, which demonstrate that our focus on getting this important service right is undiminished.

In relation to getting the vaccine to poorer communities, the noble Baroness is entirely right: there are communities where the Government are not trusted as much as they are elsewhere and where there is suspicion of the vaccine. We are working extremely hard at the department, in the NHS and with Cabinet Office colleagues to reach out to community leaders and think of thoughtful and creative ways of ensuring that the vaccine penetration among these communities is strong and that we have built the confidence and belief necessary for people to step up and take the vaccine as they should.

[Lord Rooker (Lab) [V]]

My Lords, I echo my noble friend Lord Liddle in applauding the Minister on his approach and attitude. Is it not worth celebrating the involvement and success of Turkey, Germany and Belgium in getting this vaccine to the UK? We did not order all the vaccines so early. During the next few weeks, the Health Secretary has to be the most trusted voice of Government as he rightly seeks to persuade people to take the vaccine. How can he perform this role when he has uttered a string of untruths? The latest is that the medicines regulator could only work fast because of Brexit. This is untrue and everybody knows it. I hope this problem of trust can be restored because the advice given by the Secretary of State will be crucial to the take-up of the vaccine.

[Lord Bethell (Con)]

I am slightly surprised by the tone of the noble Lord’s question. If there were ever a moment when my right honourable friend the Secretary of State for Health deserved a bit of praise and a thank you, today would be that day. That ad hominem attack was beside the point. On his serious point about trust in the vaccine, it would not be helpful for politicians to lead the charge. Our approach is to put science and the NHS at the forefront of our communications. They are truly engaged with both the expertise and the communities that need to take the vaccine.

[Baroness Walmsley (LD) [V]]

My Lords, the rollout will require many people, in addition to those giving the injection. Are there any plans to use the thousands of NHS volunteers who signed up during the first lockdown to act as marshals, drivers, identity checkers, or whatever else is required? In planning the appropriate use of the military, have the Government recognised the concerns of certain community leaders that their presence at testing sites would not reassure members of their communities who are hesitant about taking the vaccine because they do not trust authority?

[Lord Bethell (Con)]

The noble Baroness is right about the NHS volunteers. We would very much like to work with those who stepped forward. Their move was extremely welcome and kindly meant. However, the deployment of the vaccine is a precise affair. We are relying on people having to put in long hours—often not at their own discretion or convenience. Volunteers may well play a role, but the backbone and functional aspect of the deployment will rely on professional staff.

I appreciate her conundrum about the military. It is a delicate dilemma. I do not want to live in the kind of country where we turn our back on the military because some people might feel uncomfortable at the sight of uniforms on the streets. We need to build trust with communities. I want to use this moment of the vaccine to build a bridge of trust between those whom the noble Baroness reasonably described and the military. We must not make the mistake of disrespecting the military by turning them away from this important task.

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

My Lords, as the Minister who established the MHRA, I strongly endorse the Minister’s congratulations. I pay particular tribute to the outstanding leadership of Dr June Raine. I note what the Minister said about unpaid carers and the justification for not giving them priority but would the Government be prepared at least to discuss this with Carers UK? On care homes and visitor testing, which are mentioned in the Statement, is the Minister aware of calculations by Care England that the infection control fund will not cover the cost of implementing the new testing regime, let alone all the other areas for which the fund is intended? Will the Government consider increasing the fund?

[Lord Bethell (Con)]

My Lords, the support we are giving to social care throughout this period is incredibly important. I should be happy to meet with Care UK to discuss this. I cannot duck the issue. The JCVI has made its prioritisation clear. It is based on thoughtful science, infection rates and the calculation of how best to save life. While I feel compassion for carers, including some in this Chamber, we have to live with this tough decision. I cannot pretend I am going to try to change it. The inspection control fund is generous; we have put a large amount of money into it. If it proves not to be enough, we will be happy to revisit it. Protecting social care through these final few months is a big priority. I should be happy to discuss how we can do this better with the noble Lord at his convenience.

[The Deputy Speaker (Baroness Garden of Frognal) (LD)]

My Lords, all supplementary questions have been asked and answered. I congratulate noble Lords.

Medical Devices (Amendment etc.) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Wednesday 2nd December 2020 Lords Chamber

Moved by

[Lord Bethell]

That the draft Regulations laid before the House on 10 November be approved.

Motion agreed.

Human Medicines (Amendment etc.) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Wednesday 2nd December 2020 Lords Chamber

Moved by

[Lord Bethell]

That the draft Regulations laid before the House on 20 October be approved.

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

My Lords, we all believe that we must protect the safety of patients, while preserving their access to new and innovative medicines. The instruments that we are discussing today, on the UK’s regulation of medicines and medical devices, will ensure that there is a functioning statute book at the end of the transition period. This could not be more important in the context of the Government’s Covid-19 response.

The instruments are generally technical in nature and broadly achieve three things: first, they make minor amendments to existing regulations to take account of the implementation period agreed under the withdrawal agreement; secondly, they implement the Northern Ireland protocol; and, thirdly, they implement certain changes to the regulatory regime in Great Britain to ensure that the regulatory framework is up to date and functioning correctly at the end of the transition period.

These regulations do not prevent the need for future changes but they do preserve the solid foundation of the UK regulatory environment to protect patient safety and to allow the UK to remain a world leader in science and innovation. I will set out some of the key changes in the medical devices SI and then the medicines SI. However, as the SIs are long and technical, I trust that noble Lords will understand that I will not address all elements in the time we have available.

The medical devices instrument will allow CE-marked medical devices to be placed on the Great Britain market for a period of two and a half years. This will ensure continued access to medical devices for patients, while providing time for industry to adapt to future regulations. The Government have created their own new product safety marking—the UK conformity assessed, or UKCA, marking—which will be used across goods regulation in Great Britain. The SI sets out that the UKCA marking can be used for devices certified in accordance with the regulations and placed on the market in Great Britain from the end of the transition period.

The instrument makes a change to the 2019 medical devices SI, which would have inserted into domestic law provisions of the EU medical device regulation, or MDR, and the in vitro diagnostic medical devices regulation, the IVDR. By not including these provisions, we can develop our own system based on patient access, international standards and public health considerations.

The report of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege, has made it clear that we must do more to protect patient safety. The Government wholeheartedly agree. We will use the opportunity of leaving the EU to develop a robust, world-leading regulatory regime which prioritises patient safety, innovation and international best practice, using the powers of the Medicines and Medical Devices Bill.

Throughout recent constructive debates on the Bill, I have listened carefully to my noble friend Lady Cumberlege and other noble Lords. We listened to concerns and have incorporated the medical devices information system into the framework for a future regulatory system. We are also in discussion on a number of other important regulatory issues, the details of which I will not go into now for the sake of brevity. I look forward greatly to the public consultation on this future regime next year and to working closely with the life sciences and healthcare sectors on these important considerations.

I now turn to the human medicines SI. From 1 January 2021, the Northern Ireland protocol will apply, so marketing authorisations granted by the EU will continue to apply in Northern Ireland. However, medicines placed on the market in Great Britain must be authorised through the UK national route.

The human medicines SI allows the MHRA to have “regard to” decisions made by EU member states on products approved via decentralised and mutual recognition procedures when considering whether to authorise those products in Great Britain. This policy will ensure that the MHRA can continue to take effective regulatory and safety action on these products.

The medicines SI will ensure that new and existing medicines continue to be on the UK market after the end of the transition period, so that patients are still able to access them in a timely manner. This will be achieved by allowing recognition of decisions by the EU Commission to grant marketing authorisations for centrally authorised products. These products will receive a GB marketing authorisation.

Both the SIs we are discussing today uphold the Prime Minister’s commitment to unfettered access for Northern Ireland’s businesses to the whole of the UK market. The SIs include transparency requirements for medicines and medical devices moving from Northern Ireland to Great Britain, which will allow the MHRA to maintain oversight of products on the GB market and thus protect patient safety.

For medical devices, the transparency requirements mean that non-UK manufacturers placing devices on the UK market will be required to appoint a UK responsible person. The UK responsible person will be required to register devices with the MHRA in accordance with a transitional timetable set out in the regulations. Registration requirements will also apply to GB and Northern Ireland-based manufacturers. Both SIs make changes to ensure that the relevant EU laws will continue to apply in Northern Ireland after the end of the transition period, fulfilling the requirements of the Northern Ireland protocol. I reassure noble Lords that this Government will continue to regulate medicines and medical devices in a way which works for the whole United Kingdom, including, of course, Northern Ireland.

The MHRA will continue to regulate medicines and devices in Northern Ireland. This will ensure continuity for patients and for businesses. Moreover, the Medicines and Medical Devices Bill, currently passing through this House, will provide the powers for future changes to the UK’s regulatory system. Within this, and having tabled an amendment in my name, what is now Clause 43 requires a public consultation on regulatory change before making use of the relevant designated powers in the Bill. The consultation process will help to ensure that the interests of the all interested parties, including devolved Administrations such as Northern Ireland, continue to be fully considered. Officials have kept the devolved Administrations informed of the drafting of this instrument and I am grateful for their continued collaborative approach. In particular, I thank the Minister of Health in Northern Ireland, Robin Swann, who agreed—despite policy for human medicines being a devolved matter—to the human medicines SI being signed solely by the Secretary of State for the Department of Health and Social Care.

To inform the industry, we have published a number of guidance documents which go into further detail on the changes included in the SIs on GOV.UK. In addition, an accompanying series of webinars were held where officials engaged directly with 11,500 industry representatives and provided them with an opportunity to ask questions. My officials also meet regularly with top industry companies and key trade associations, including the Association of the British Pharmaceutical Industry, the BioIndustry Association and the Association of British HealthTech Industries.

It is important to note that these instruments amend pre-existing EU exit legislation made in 2019. A full consultation process was conducted for this pre-existing legislation. Moreover, full impact assessments were conducted for this underlying legislation. As the nature of the changes in the instruments that we are discussing today are in many instances technical, the impacts of these SIs above and beyond the existing legislation do not meet the threshold for further impact assessments and hence these are not provided for. These instruments will ensure that the UK’s exceptional standards of safety and quality regulation of human medicines and medical devices are maintained and enhanced. At a time when we have never been more reliant on all the elements of our public healthcare system for our survival, we must support this. I beg to move.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I am enormously grateful for the penetrating and thoughtful questions on this important set of SIs. There were far too many for me to be able to cover them in all the detail they deserve this afternoon, but I will undertake to write to noble Lords if I have failed to address any specific questions.

I start by sharing with the noble Lord, Lord Blunkett, the very positive vibe he gave out about the vaccine. He is entirely right that I have been at this Dispatch Box answering questions on PPE, test and trace and all manner of government challenges, but today is a great day. I do not want to bang on about it, but it is a huge relief to see the authorisation of this vaccine: it is a huge triumph for medical science and a massive breakthrough for humanity. I cannot help emoting so positively on it.

On the precise procedures used, I reassure the noble Lord that, in fact, the procedures used for the authorisation of this vaccine were exactly the same as those we could have used, and do use, under current EU regulations—as he probably knows. Those will change at the end of the month, but, as he probably knows, in October, we brought in specific regulations to allow us to have this opt-out procedure. I pay tribute to the EMA, which is a fantastic regulator with which we intend to work extremely closely. I pay enormous tribute to the MHRA, which has worked with phenomenal diligence, enormous scientific insight and great precision and confidence in order to get this authorisation done so promptly. Dr June Raine, who runs the MHRA, has done a fantastic job, and we should be extremely proud of the role of British regulation in this matter.

On a serious point, this incident demonstrates some of the benefits that will come to Britain’s life sciences industries from the transition. As noble Lords will know very well, we are not planning a massive divergence from either the EMA or the cohort of other regulators—the FDA and others—on a large number of matters. In fact, we have a huge amount of respect for our partners in other countries, especially the EMA. However, in the areas of innovative medicine, where there are new techniques and novel science, and where thoughtful, rapid processing makes a huge impact on the velocity of innovation and where expertise and scientific insight are particularly important, Britain can make a difference. This is where the MHRA will help not only British industry but all of humanity. I very much look forward to reporting back to the House on the progress that we can make in that area.

There have been a large number of questions from noble Lords on whether we are ready for these changes. I assure all noble Lords that we are in great shape. We are in constant liaison with industry and I have regular phone calls, meetings, webinars and bilaterals with industry to ensure that things are in good shape. When it comes to batch testing, which was raised by the noble Baroness, Lady Wheeler, the stockpiling of medicines, and the other matters raised, I can assure noble Lords that we are indeed in good shape. The noble Baroness asked specifically about our conversations with the DPRRC; I cannot give precise answers to her detailed and very reasonable questions, but I will write to her.

I am particularly abreast of the matter of stockpiles, having presented to the Project Defend board earlier today for three hours. I assure noble Lords that the Government are considering the resilience of the country as we approach not only the transition, but also the ongoing pandemic and the winter, simultaneously. We are in very good shape. There is a nationwide, government-wide project to ensure that we are truly resilient. In terms of health provisions, this means not only having stockpiles, but also strengthening our relationships with our suppliers, ensuring the provenance of those supplies and, where necessary—I emphasise that—building up domestic supply. Phenomenal progress has been made regarding medicines and devices, as well as PPE, which typically one associates with production in Asia. We are currently producing more than half our PPE in the UK, and it is possible that we will be producing more than that.

The noble Baroness, Lady Wheeler, is entirely right about the MHRA. We have a winning organisation there, but the emphasis and pressure on it going forward will be extremely important. I assure her that I have regular meetings with the MHRA through the spending review, and its financial plans have been gone through with a fine-toothed comb. Both the MHRA management and the policymakers at the department are reassured that the budgets and the human resources are in place for the MHRA to step up to that challenge.

These are important regulations. I am extremely grateful for the scrutiny that noble Lords have given them and, in that spirit, I commend them to the House.

Motion agreed.

HIV: Ending Transmissions

Lord Bethell Excerpts

Tuesday 1st December 2020 Lords Chamber

[Baroness Barker]

To ask Her Majesty’s Government what progress they have made towards ending HIV transmissions by 2030.

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

My Lords, the Government remain fully committed to achieving zero new HIV transmissions in England by 2030. This is why we endorsed the HIV Commission, which was established by the Terrence Higgins Trust, the National AIDS Trust and the Elton John AIDS Foundation, and we welcome its report, published today. I reassure noble Lords that we will consider all the recommendations carefully, including an interim milestone of an 80% reduction in new HIV transmissions by 2025, and how we can expand testing. We will use the insights of the report to shape our upcoming sexual and reproductive health strategy and HIV plan.

[Baroness Barker (LD)]

I thank the Minister for that reply. I am very proud to a member of the party which, before anybody else, advocated that there be services for people with HIV and AIDS, and we will be there until this report is fully implemented and the fight against AIDS is won. Will the Government move to introduce a system of opt-out testing so that all people, including men and women from black and minority ethnic communities, can know their status, and we can get sooner to the point where they can get treatment and stop transmission?

[Lord Bethell (Con)]

The noble Baroness refers to one of the most interesting of the recommendations of the commission’s report. I took a briefing from the commission yesterday; members made that point very clearly, and their arguments were extremely persuasive. We have learned a lot during the Covid pandemic about opt-out testing; I completely understand the value of it, and I will take that recommendation to the department to look at it very closely.

[Lord Herbert of South Downs (Con)]

My Lords, I pay tribute to the long-standing work of the Lord Speaker on HIV and AIDS. I have campaigned beside him in South Africa and have seen the passion with which he devoted himself to this role over many years.

Does my noble friend the Minister agree that the HIV Commission’s recommendation for a plan that the Government should commit themselves to is a wise one which they should adopt? After all, it is D minus 10 now—10 years before AIDS should be beaten, according to the SDG. We have the tools, now we need to implement them.

[Lord Bethell (Con)]

I reiterate the tribute of my noble friend to the Lord Speaker. Over three decades, he has campaigned tirelessly on these issues, and was instrumental as Secretary of State for Health and Social Security in launching the ground-breaking “Don’t Die of Ignorance” campaign, which made an indelible mark—its impact is remembered today. The tenacity that he has shown in making evidence-based decisions in the fight against HIV is a model for us today.

My noble friend makes a very valid point on the need for a plan. We will issue a sexual health and an AIDS plan in short order; they have been delayed by Covid. He reminds us that it is D minus 10, a goal that we take extremely seriously.

[Baroness Clark of Kilwinning (Lab)]

We know that stigma, even fear, can often prevent people going for tests. What does the Minister think we can do to improve the uptake of testing, particularly from those who are at the highest risk of contracting HIV? What does he think we can do to improve the training of those who provide testing to make sure that in future people are more likely to take tests?

[Lord Bethell (Con)]

My Lords, we have made great progress in the area of tests, hitting the UNAIDS 90-90-90 target for the third consecutive year, with 94% of those living with HIV diagnosed, 98% of those diagnosed getting treatment and 97% of those undergoing treatment having an undetectable viral load. The noble Baroness is entirely right: one of the greatest challenges is those who are not tested because they do not know that they should be tested. Part of that is stigma and part of it is encouraging people to step up to get tested. That is the focus of the recommendations in the HIV Commission’s report, which we take very seriously. It has clear recommendations on marketing, which we will be looking at very carefully.

[Baroness Sheehan (LD)]

The Global Fund to Fight AIDS, Tuberculosis and Malaria warns that additional support is badly needed to prevent a reversal in “hard-won gains”. Will we, as a lead funder, join Germany, Italy, Canada and South Africa to increase our contribution to the fund as a matter of urgency? A Written Answer will suffice if that is not in the Minister’s briefing notes.

[Lord Bethell (Con)]

The noble Baroness makes a very good point. The UK Government will continue to be a world leader in our HIV response through our considerable investment in the Global Fund to Fight AIDS, Tuberculosis and Malaria as well as through supporting the Robert Carr Fund to advocate for the rights and needs of the most marginalised groups, such as LGBTQ people and sex workers. In relation to reassurance on the point she asks about, I cannot provide that from the Dispatch Box, but I reassure her that our commitment to these international causes remains robust.

[Lord Collins of Highbury (Lab)]

My Lords, this is a global fight, and, as the noble Lord mentioned, this target is for the SDGs that apply throughout. If we are to meet the global agenda of no new transmissions of HIV by 2030, how will the Government work with all major funders, as he mentioned, to collectively invest the £36.49 billion needed for HIV programming for key populations over the next decade?

[Lord Bethell (Con)]

My Lords, I have already precisely outlined some of our commitments to international funding. Two other areas where we contribute are, first, through our example: by marching resolutely towards the zero transmissions target, we set an important global example, which should not be underestimated. The second is the contribution of our science community, which has been profound and has contributed huge medical insights to the scientific progress on antiviral drugs and in the fight against AIDS.

[Lord Black of Brentwood (Con) [V]]

Does my noble friend agree that one of the biggest barriers to meeting the 2030 target is the stubbornly high rate of late diagnosis, which not only has serious repercussions for the individuals concerned but contributes significantly to health inequality? Does he support the following recommendation in the HIV Commission’s report:

“Every late diagnosis must be viewed as a serious incident requiring investigation … and a report produced to drive change in local health systems”?

[Lord Bethell (Con)]

My Lords, I noticed the recommendation that every late diagnosis should be regarded as a major contagion, reported and followed up by an authority such as PHE. This is something for PHE to consider for itself, but I will certainly write to it to raise the recommendation and ask it to respond to me.

[Lord McConnell of Glenscorrodale (Lab)]

My Lords, the doubling of mother-to-child transmissions around the world is just one of the implications of this year of instability in health services around the world caused by the Covid-19 pandemic. In my experience around the world, one of the greatest fears of those living with HIV is instability, whether that is caused by climate change, conflict or pandemics. What are the Government going to achieve by cutting £4 billion in overseas development assistance when these great crises need so much attention at this time?

[Lord Bethell (Con)]

The noble Lord speaks with great humanity and compassion, but I perhaps need to give a bit of perspective. I am not sure if our UK aid budget is enough to solve all the problems that he describes. The UK remains extremely committed to international aid. In the Covid epidemic and recession, we have reduced our commitment in a small way and have promised to revisit it at a later date. That commitment is very clear, and we will do that in due time.

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

My Lords, cuts to local authority public health budgets of some £700 million in real terms over the last five years have led to sexual health budgets being cut by 25% in this period. The King’s Fund has estimated that restoring spending to the former level

“would require additional investment of £1 billion.”

Given the Government’s commitment to zero new HIV transmissions by 2030, will the Minister tell the House what plans they have to increase investment in HIV preventive services delivered by local authorities? Can the Minister also confirm that there will still be national funding for a prevention programme?

[Lord Bethell (Con)]

The Covid epidemic has disrupted things, but I reassure the noble Baroness that in the spending review 2020 we have confirmed that the public health grant will be maintained into next year, enabling local authorities to meet pressures and continue to deliver important public services. DHSC will confirm final allocations in the coming week, including the position on HIV PrEP. I reassure the noble Baroness that PrEP has proved to be an enormously valuable contribution to our fight against transmissions, and we continue to back it.

[The Lord Speaker (Lord Fowler)]

My Lords, I fear the time allowed for that Question has elapsed.

Nutrition (Amendment etc.) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Tuesday 1st December 2020 Lords Chamber

Moved by

[Lord Bethell]

That the draft Regulations laid before the House on 29 September and 21 October be approved.

Relevant document: 33rd Report from the Secondary Legislation Scrutiny Committee. Considered in Grand Committee on 25 November.

Motions agreed.

HIV: Pre-exposure Prophylaxis

Lord Bethell Excerpts

Tuesday 1st December 2020 Lords Chamber

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

My Lords, the Government recognise the huge impact that HIV pre-exposure prophylaxis plays, as part of a combination of prevention interventions, in reducing HIV transmission. That is why we have provided £11 million to local authorities during this financial year for routine commissioning of PrEP. We are continuing to work closely with local authorities and other stakeholders to support the rollout, which will benefit tens of thousands of people.

[Lord Cashman (Non-Afl)]

[Inaudible]—study has shown that they are 100% effective when taken properly and there is no difference in reports of condom use. More importantly, contradicting the claim that access to PrEP would somehow encourage an increase in risky sexual behaviour, there are no other STIs. Therefore, given that one of the key barriers to increasing access to PrEP is it being delivered exclusively through sexual health clinics, what discussions have the Government had about expanding access to PrEP to other healthcare settings such as gender clinics, maternity units, GPs and pharmacies?

[Lord Bethell (Con)]

My Lords, the noble Lord makes a completely fair point. There is absolutely no question of there being a social stigma associated with taking PrEP or any kind of moral cloud over those wishing to take this important therapy. That is not in any way our purpose. He makes a valid point that there are good arguments for the supply of PrEP to be not just through GUM units but also through GPs and perhaps pharmacists. These are arguments that we hear and that we are looking at very closely. I hope that, at some point, I will be able to update the noble Lord on our progress on this matter.

[Baroness Thornton (Lab)]

I remind the Minister, with regard to his last answer about funding, that just because you cannot solve all the world’s problems does not mean that you should not try to solve some of them. On that basis, can the Government provide an update on the rollout of PrEP in England? Is the Minister aware that there are local authorities that are still not providing the drug? When the ring-fenced funding for PrEP runs out in March 2021, will the Government commit to at least the £16 million per annum to make this happen for the future?

[Lord Bethell (Con)]

The noble Baroness makes a fair point. The rollout of PrEP has reached a great many local authorities but not all of them. The funding for it, at £11 million, has made a big impact but it has not covered all the ground. We are aware that this funding package runs out next year and we are in active engagement with local authorities in order to find a new mechanism going forward before July, when the funding will change. That said, our commitment, as I said earlier, to the principle of PrEP and its impact on reaching our targets for transmission remains resolute. I look forward to being able to announce a resolution of this funding formula.

[Baroness Jolly (LD)[V]]

My Lords, access to sexual health services has always been more difficult in far-flung areas such as Cumbria and Cornwall. Often, young gay men do not like approaching the GPs they have known since childhood. The Minister referred in an earlier answer to PrEP. Is he confident that there are adequate alternative opportunities to get local access to PrEP? Will he commit to talking to those in the department who deal with the plan, and will he write to me with a date when PrEP might be easily accessible all across England and put the response in the Library?

[Lord Bethell (Con)]

The noble Baroness makes an entirely fair point. Access to PrEP is not as even as it could or should be. It is a very important tool in our fight against the transmission of HIV, and it is a programme that we support wholeheartedly. However, it takes time to roll out a therapeutic such as this through the entire healthcare system. We have focused its supply through sexual health units because they are the most thoughtful and reliable places for the kind of consultation and expertise needed for a delicate new therapeutic like PrEP. However, she raises a good point that perhaps this should be and could be updated.

[Lord Scriven (LD)]

My Lords, since 2017, both Scotland and Wales have supplied uncapped access to PrEP, so will the Minister tell us what is stopping uncapped access to PrEP in England, so that we do not have a postcode lottery for access?

[Lord Bethell (Con)]

The noble Lord will be aware that there is a detailed conversation with local authorities about ensuring that we get exactly the right balance for funding. As the noble Baroness rightly pointed out, we need to make sure that the supply of PrEP is conducted in a way where there is good consultation and where those who are applying for the therapy are given good advice. That is best done with help from local authorities, and we are trying to hammer out a deal to ensure that that is done thoughtfully. That deal has been delayed by Covid, but we are looking forward to announcing a resolution of that before the next funding round finishes.

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

My Lords, can the Minister confirm that the Government are collecting information on who is accessing PrEP in England? It is obviously crucial to ensure that there is equity among the groups given the currently limited supply, unlike the situation in Scotland and Wales, to which the noble Lord, Lord Scriven, has just referred. Will the Government commit to publishing the data on who is accessing PrEP?

[Lord Bethell (Con)]

I am not sure that I can give the reassurances that the noble Baroness is looking for. These are very delicate and private matters. I am not sure if it is right that the details of who is accessing PrEP are necessarily for are public domain, but I would welcome any suggestion that she might have in correspondence about what exactly she is looking for.

[Lord Paddick (LD)]

My Lords, in January 2016, the results of the PROUD study, in which I was a participant, showed a 90% reduction in HIV infections in those who took PrEP and no increase in other sexually transmitted infections. Why did it take the Government four years from the publication of these results to make PrEP available in England? What are the Government doing to increase the awareness of PrEP among women and the black community?

[Lord Bethell (Con)]

I am afraid that I was not a Minister in the period that the noble Lord is talking about, so I cannot account for that. However, I agree with him that, on the point he raised about access to PrEP among women and the black community, we have a case to answer. I completely acknowledge that, particularly among the black community, this is one of the most difficult areas that we have to tackle in order to hit our objective of zero transmissions by 2030. We are working extremely hard to try to reassure those who are hesitant about taking on such therapies that they are safe, accessible, private and relevant. We need to win that battle in order to hit our target.

[The Lord Speaker (Lord Fowler)]

All supplementary questions have now been asked and we will therefore move on to the next Question.

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

Lord Bethell Excerpts

Tuesday 1st December 2020 Lords Chamber

Moved by

[Lord Bethell]

That the Regulations laid before the House on 30 November be approved. Instrument not yet reported by the Joint Committee on Statutory Instruments.

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

My Lords, we know this virus well enough now to know that it is not an inconsequential enemy. It has taken loved ones from us, including my godfather, Alan Williams, who some in this House may know. It has separated us from our friends and families and has left people suffering from its ill effects months after first falling ill. This country has made a great collective sacrifice throughout this year, but it has been integral to combating the virus. Regretfully, much as we would wish it were true, this virus cannot be ignored. It has not mutated into a gentler version of itself or blown itself out in the wind. Instead, it remains on the rampage, highly contagious, malicious and mortal, with the old and vulnerable square in its sights, and anyone potentially affected.

While I know that these measures have been hard, this is the reason why we have taken this course. They have always been proportionate to the threat that we face. However, I reassure noble Lords who might be in any doubt that we do not want to leave them in place for one day longer than we have to. We now judge this to be the right time to come out of the national lockdown and revert to a localised approach to managing the virus. Why is that? It is because coronavirus cases are down by 19% in England and hospital admissions have fallen by 7% compared to a week ago. The data tells us that, after many false peaks, the virus curve is finally flattening. The latest assessment from SAGE is that, having reached the summit, we are now walking down the other side, with the R for the UK between 0.9 and 1. Indeed, in its most recent survey, Imperial College London placed its estimate for England at an impressive 0.88.

This is a monumental achievement. After more than three months of growth, this is the first time the R has been estimated at or below 1 for the United Kingdom since mid-August, so at last we can be confident that the virus is coming into check. Only at that point is the danger of our hospitals being overrun starting to pass.

While this drop in the infection rate is encouraging, and confirmation that our national sacrifice has proved successful over the last few weeks, the picture remains varied across the country. That is why we are introducing a framework of regional tiers so that interventions are suited to the situation in any given area. There will be three tiers that apply to the whole country—but, before I go on to them in more detail, I want to spend a moment on the principles that underpin all three.

First, I reassure noble Lords that schools will remain open to protect children’s education and development. Secondly, we will seek to keep as many businesses open and trading as is reasonably possible, to support the people who work within them and the wider economy.

Beyond these core principles, as the winter plan sets out, there are the five key factors in determining the tier of any region: case rates in all age groups, cases among the over-60s in particular, the rate at which cases are rising or falling, the positivity rate and the pressure on the local NHS. When setting boundaries for these tiers, we have looked not only at the human and physical geographies that determine how the virus spreads but at travel patterns and the epidemiological situation in neighbouring areas. We have listened to the public voice, and noble Lords in this Chamber, to fine-tune the system. As a result, people can practise their faith in places of worship, gyms will remain open, outdoor leisure will be permitted and we are doing everything reasonable to allow businesses to remain open.

I turn to the details of each tier. The aim of tier 3 is simple: to bring down the rate of infection when rates are rising too fast. That requires considerable collective effort. Tier 3 will be used only when necessary, in order to protect the NHS and save lives where the virus is threatening to get out of control. Tier 2 is intended rigorously to manage the spread of the virus, restricting indoor mixing outside your household or bubble, although the rule of six will apply outdoors. Hospitality will be open but with restrictions on opening hours and serving alcohol. We want to help all local authorities to move down to tier 1, the least restrictive tier. It has been designed to contain the virus and limit new potential outbreaks. It will apply in areas where efforts to suppress the infection have been successful, and represents a relative return to normality, including for the hospitality sector, although the rule of six for social contact must be maintained.

I reassure noble Lords that the decision to put areas in these tiers was made according to the best possible data and clinical advice. This system offers a sustainable and enduring framework for controlling the virus, as well as offering consistency, stability and clarity on the steps people should take to control the virus. On the effects of these measures, I draw noble Lords’ attention to the evidence paper on the health, economic and social effects of our approach that was published by the Government yesterday. This analysis recognised that:

“The impacts of COVID-19 to date have been significant on health, the economy and society.”


However, it makes clear that:

“Allowing the virus to grow exponentially would lead to”


worse

“impacts, in terms of loss of life and ill health”

and the economy, and

“that would be considered intolerable for society.”

The analysis provided in our paper has been informed by evidence from SAGE and its sub-groups, the ONS, forecasts from the OBR and data on the epidemiology of the virus. As the paper sets out, the balance of evidence supports the need for our tiered approach.

However, the tiers are not the only weapon in our arsenal. We are launching a major community testing programme targeted on the tier 3 areas with the greatest rate of infection. Test and trace will work with local authorities on a plan to get tests to where they are needed most, using military support where helpful and designing their own incentives to attract the right groups. The tier regulations are supported by an increased focus on enforcement and compliance, which is what the local authority enforcement powers regulations are all about.

Throughout, we have listened to and engaged with local authorities to understand how we can support our partners in local government and make sure that they have the right tools in place to ensure that rules are being followed. We know that these are the right tools because our partners in local government helped us to design and build them. The coronavirus improvement notices allow businesses to be given a clear and consistent notice, outlining what changes must be made to meet specific requirements set out in named regulations.

Local authorities will be able to use the notices as an effective tool to communicate with businesses before a fixed penalty notice is issued. These regulations reflect feedback from business and others, who are doing their utmost to support NHS Test and Trace. The changes will support businesses to comply with the legislation while ensuring that NHS Test and Trace has the information it needs to contact people who may have been exposed to the virus.

Finally, by keeping the virus under control through December, the Government can enable everyone to see more of their family and friends over the upcoming festive season. These regulations make provision for extended Christmas bubbles that will allow three households to mix between 23 and 27 December. When following these new rules, it is vital that we continue to take personal responsibility to limit the spread of the virus and protect loved ones, particularly if they are vulnerable. The year 2020 has proved to be an extraordinary one that has brought a lot of hardship and heartache for everyone. With the winter bank holidays on the horizon, we believe it is important that people are able to see some of their family and friends during this time. We have been living with this virus for too long.

As we go into winter, our emphasis is on reducing the pressure on the NHS at a time when hospital admissions are already considerable. Our approach is guided by the need to mitigate the virus as much as possible. We have considered the needs of the British people and are seeking approval here to implement a system that remains uniform and clear, wherever in England you might be. It also provides a proportionate and measured response to the continuing threat of the virus. The tier system is not just a government policy; it is a national endeavour that we must all continue to be active players in, because this virus threatens us all, so we must all play our part in keeping it under control.

I know that these are tough sacrifices at the end of a year of sacrifices but, to continue to be able to protect education and the economy, we must continue to limit our social contact with other people where possible. I commend the hard work and dedication shown by the British public through these trying times. Hope is on the horizon, with new scientific advances being made every day, but we still have further to go. Until science can make us safe, we must put in place these new rules, which will help us to keep the virus under control. I commend these regulations to the House.

Amendment to the Motion

Moved by

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, it has not been the most comfortable two and a half hours of my life, but I have profound sympathy for a huge amount of what has been said in this debate; I really do. I completely understand where the Opposition Benches are coming from on some of the major themes raised. I will go through some of those in detail, but I will summarise briefly before moving on.

On test and trace, I understand the frustration that those on the Opposition Benches have voiced, but I would like to reassure them that the numbers have come up dramatically, that Thursday’s numbers were incredibly impressive and that this Thursday’s will be even more impressive. A massive amount has been done to address the concerns they have quite reasonably voiced in the past.

Huge strides have been made on collaboration with local authorities in the last few weeks. The publication yesterday of the community testing document and the process around that is proof that those commitments are sincere. I have been held to task on the clarity of government communications many times over the last seven months. The way in which even these restrictions have been communicated has had a lot of thought and has landed very clearly indeed.

On my own Benches, there have been extremely clear messages that I personally agree with wholeheartedly on a sentimental basis. Who would want to stand at the Dispatch Box today putting a restraint on the liberty of the British public of the kind we are looking at in these statutory instruments? This is a joy to absolutely no one, and it is done with a huge number of reservations, with concern and with a full understanding of the implications.

On the economic case, I do not need to be told by anybody about the implications of these restrictions on our economy. I know from my own life, my friends and those I love what they mean to our economy. I feel that very harshly indeed and assure noble Lords that those matters are taken fully into account when we put these statutory instruments before the House.

On the complexity of some of these statutory instruments, we are dealing with a difficult and complex situation. Noble Lords have rightly ridiculed the language used, and I have greatly enjoyed some of the language used in tearing into these statutory instruments, but I cannot hide from noble Lords the fact that to be effective they have to be legal. Legal language is sometimes funny but always necessary. We need to do things in a thorough, thoughtful way.

I have sat in more meetings with experts in the last eight months than anyone else in this House, and they drive me nuts, but we appreciate and value the scientific dialectic. We have approached it with an enormous amount of transparency, and there is no point in scapegoating those who posit the best ideas they can. It is up to us as the decision-makers to make our choices, not to blame the experts for the advice they give us.

Lastly, on the democratic element, I have stood here and apologised for the late arrival of statutory instruments and the retrospective nature of some of these debates. But I remind everyone that I am standing here ahead of the application of these statutory instruments and, as the noble Baroness, Lady Thornton, just reminded us, next door—in the other place—they have been approved by a vote of 291 to 78, which is an emphatic win for the Government.

Before I move on, let me tackle a couple of the key questions; I cannot possibly address all the issues that have been raised today. My noble friend Lord Robathan covered an enormous number of points, and I very much value the challenge he brings to the Government in these matters. I remind him that we are all sobered by the statistics that he cited on suicides and cancer, and, of course, those numbers are far too high. I cannot help thinking that, at the end of all of this, we are going to rethink the value of life and think about how much more we can do to address questions like suicide and cancer. But no one is suggesting that we are facing a tsunami of either cancer or suicides that threatens hundreds of thousands of lives in the next few months, or that it might overwhelm the NHS. Therefore, the parity he suggests is not right.

I completely sympathise with the points that my noble friend Lady Neville-Rolfe made so eloquently and thoughtfully on the impact of regulations such as these on the economy and, in particular, on the hospitality sector. I reassure her and all other noble Lords who have raised, quite reasonably, the impact on the economy of these regulations that we absolutely think about education, business and the secondary health impacts of these regulations on the country.

However, when asked about the impact assessment, I remind noble Lords of the very important work done by the ONS, the Home Office, the Department of Health and Social Care and the Government Actuary called Direct and Indirect Impacts of COVID-19 on Excess Deaths and Morbidity. That is a detailed analysis of the various impacts of a strategy of letting the disease take its course, and if anyone wants any guide to what the alternative looks like, that report spells it out extremely clearly indeed. I am extremely disappointed whenever people raise the question of cost-benefit analysis and government analysis that this report is not cited more, because it is an excellent piece of work, and I highly recommend it.

My noble friend Lord Lilley speaks of an institutional bias and groupthink. I respect his challenge enormously. He is entirely right to warn any organisation, particularly one in the grip of a serious pandemic, about falling into the trap of any kind of groupthink. But I remind him that there have been moments when the groupthink went the other way. I remember very well at the beginning of this pandemic, when people told us that Covid was going to be like flu—and then many millions have died around the world. I remember when people said that it would never come to Britain and that it would stay in China where it started, but then the cruise ships showed that the disease did travel, and when it started travelling, it would not stop.

There were those who initially denied that the lockdown in March was necessary, but I think there are few people who would make that case right now. There were people who said that antibodies and T cells would somehow mean that large sections of the population would be resistant to the disease. That has been seen not to be true and, in fact, antibodies in the UK—now that we have tested hundreds of thousands, or millions, of people—are rarely more than 10%, and show every sign of fading away in some people. There were those who thought that the disease might just blow itself out and mutate into something that was harmless, and that the second lockdown was unnecessary. Professor Spiegelhalter has predicted 20,000 deaths before Christmas, and I am afraid that the second lockdown absolutely has been necessary.

I completely understand my noble friend Lord Howard of Rising’s aspiration of somehow segmenting demographics. He makes it sound easy, as if we could somehow split older people off from the rest of society. However, it is not only the view of SPI-M that this is impossible but the view of every single country in the world. Not one country has managed to do what he suggests. It is simply not possible. He may not like this answer and feel that I have not answered him completely but, as on the 180 times I have stood at this Dispatch Box in the last eight months and in the 1,000 letters I have replied to, I am afraid that this is one of those cases where I have sought to answer his question, even if he does not like the answer.

I completely agree with my noble friend Lord Ridley that persuasion is of course better than compulsion. That is exactly the approach we have taken. We have tried to use consent wherever possible. If you speak to the police force or any of the agencies of the state, you will find that that is absolutely the principle we have taken. I also completely agree that the authoritarian approach of China, Korea or Taiwan may suit those cultures and political systems, but they are not for us. However, he is completely wrong to think the public are not with us on our approach. In September, 62% of the public supported our rules; in October, it was 72%; and in November, it was 73%. Some 89% support the wearing of masks and 77%, even now, support the rule of seven. And 76% support the closing of bars and restaurants where necessary. I fear that, sometimes, noble Lords in this Chamber are out of step with the heart of public opinion. While I agree ideologically with the points they make, it is wrong to suggest that they are speaking on behalf of the public in these matters.

I am extremely glad that my noble friend Lady Meyer and the noble Lord, Lord Birt, mentioned the vaccine, because that is very much the focus of our efforts. These restrictions are merely a bridge to get there. No one wants to live under the terms of these statutory instruments. I can report that progress on the vaccine is extremely encouraging; I am grateful to the scientists designing it and those involved in its deployment.

The noble Baroness, Lady Barker, speaks with so much truth and wisdom in her interventions, but I push back slightly on her remarks on the shielding letters. I know my noble friend Lord Cormack thought that they were wise. The shielding letters are extremely clear because people asked for them to be clear. We work very closely with stakeholders to make sure that they are right, and they are passed to stakeholders for their consent before they go out. The 76-page documents are very long because people want to know the answers to detailed questions. When we ask them what kind of detail they want, this is exactly it. The extract the noble Baroness read out seemed to me a model of clarity and exemplary in the wisdom of its advice.

I am afraid to tell the noble Baroness, Lady Hayman, that, if you are going to have boundaries, they must lie somewhere. Regions need boundaries. When you live on the side of one, that is always uncomfortable, but I know no other way of dividing the country.

Where I completely agree with the noble Baroness, Lady Hayman, is on her reference to Dame Sally Davies, who has a point when she says that social deprivation, bad diet and bad living habits have undoubtedly contributed and hit the country hard in this epidemic. Sally Davies is completely right that there is a social justice issue here. Levelling up, which I campaigned on in the last election and which the Prime Minister has evangelical support for, means health outcome equality, if it means anything at all. I completely share the aspiration that a benign outcome of this awful disease would be a national commitment to this agenda, not only for the principles of social justice but, pragmatically, for national resilience.

I will say a few words about trust and authoritarian measures to my noble friend Lord Cormack, who had extremely harsh words about the Government’s motives and their actions. I respectfully remind my noble friend that the Government are not conspiring to separate families, isolate the vulnerable or close businesses but this awful virus. That is what is causing the trouble, and it is our commitment to protect the vulnerable, businesses, the health service and, thereby, to protect the economy and the very fabric of society that leads us to this point. I completely sympathise with his frustration and I take his concerns about liberty seriously, but he is aiming at the wrong target.

The noble Lord, Lord Scriven, asked about the accuracy of lateral flow tests, and I would be happy to enter into correspondence with him on this. It is a short measure. I reassure him that these are an extremely effective screen. We have been using millions of them up and down the country and have become extremely experienced with them. They are not the tests we would use if you were going to go into an operating theatre, but they are the tests we would use if you were going to see Granny.

The noble Lord, Lord Scriven and my noble friend Lord Cormack asked about public understanding of government measures, which is a relevant, pertinent question. I reassure them both that the Centre for the Mathematical Modelling of Infectious Diseases has found that mean contacts—the number of contacts each original case study had—increased gradually from early April to July, which is exactly what we learned during the summer, when contacts began to grow. Since then, contacts peaked in mid-September and have come down, which is an indication that people are taking more seriously the strictures of the Government to socially distance and reduce social contact.

The noble Lord, Lord Greaves, spoke with great humanity about the plight of those in Pendle and the north. I reassure him that we do not think that it was only community testing that led to the decline in Liverpool but the commitment of the political leadership and a terrific civil effort on the part of the whole city. However, community testing did help. It not only helped break the chain of transmission but helped focus minds on the disciplines of epidemic control. He is right that the Army cannot do everything and that the priority is to test people who are most likely to have the disease. On the £500, it has undoubtedly been a struggle for both councils and individuals to claim the money, but we have, as of yesterday, made it accessible through the app, which I hope will change matters considerably.

The noble Baroness, Lady Thornton, and others asked about support; we have provided unprecedented levels of support to businesses and individuals. That includes helping to pay the wages of people in 9.6 million jobs across the country through the Coronavirus Job Retention Scheme, protecting jobs that might otherwise have been lost, and supporting the livelihoods of 2.7 million self-employed workers. Businesses have received billions in loans and tax deferrals.

By way of summary, the noble Lord, Lord Birt, made this central public health insight that we have all learned throughout this pandemic. My health is no longer a private matter. What I have realised is that I might have Covid, therefore, I might infect my neighbour. If I get ill, I will take up a bed in a hospital, and that bed will not be available for you. In other words, this is a classic liberal dilemma, which a number of noble Lords referred to. Of course, we respect everybody’s freedom and liberty but at this stage, with this horrible contagious disease spreading around the country, I am afraid we are all dangerous to others, and that is why we have to bring in statutory instruments such as the one we are looking at today.

Around 633,000 people in Britain have Covid today. We are doing our best. Some 246,298 were isolated by track and trace between 22 and 28 November, but we are going into the winter with far too many people walking the streets, schools and hospitals with a highly contagious and dangerous disease. That is why we have the restrictions we are looking at today, why I stand by them and hope your Lordships will support them, why I hope my noble friend and others will withdraw their amendments, and why I commend these regulations to the House.