Covid-19: Variant

Lord Bethell Excerpts

Wednesday 13th January 2021 Lords Chamber

[Lord Scriven]

To ask Her Majesty’s Government when they first became aware (1) of the new variant of COVID-19, and (2) that such a variant of the virus was prevalent in the areas placed into Tier 4 on 20 December 2020.

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

My Lords, the second variant is a very serious matter. On 8 December, analysis of all genomes available in Kent showed that a new variant was circulating. Ministers were notified on 11 December. On Monday 14 December, the Health Secretary informed Parliament, PHE released a statement and the Government held a press conference on the new variant.

[Lord Scriven (LD) [V]]

My Lords, variant B117 was identified in October. From the second week of December, virus cases started to rocket in London and the south-east, yet the Government’s focus was on how to keep people mixing at Christmas, not on dealing with the alarming spread of the virus, ignoring public health experts who said that a tight lockdown was urgently required. What message of apology does the Minister have for those families attending funerals because the Government acted too slowly to help save lives?

[Lord Bethell (Con)]

My Lords, I am afraid that I just do not recognise the noble Lord’s proposition. Hundreds, if not thousands, of new variants are appearing all the time. Many of them have passed through the process, but identifying those that are threatening, have more transmissibility and are significantly different is extremely complex. As I said very clearly, it was on 8 December that, after analysing all the genomes available in Kent, we showed that an important new variant was circulating.

[Lord Winston (Lab) [V]]

My Lords, clearly these variants are extremely—[Inaudible]—for all sorts of reasons. Regrettably, the Minister did not answer the question put by my noble friend Lady Thornton yesterday, when she questioned incomplete vaccination. Can the Minister give us clear figures on the risk of mutant varieties of the virus with a longer period between the two injections of the Pfizer vaccine?

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, the noble Lord has more medical expertise than me to be able to answer that question, but the briefing that I have is that the significant mutation in the Kent variant is not of a kind that should affect the efficacy of either a single dose or two doses of the vaccine. This comes as a significant relief to the vaccine programme. We remain on the balls of our feet, looking out for any variations that might affect vaccine deployment, but at this stage we have not found anything that poses a significant threat.

[Baroness Barker (LD)]

My Lords, the ONS data in the second week of December showed that the number of cases from all variants of the virus had rocketed. Why did the Government fail to act on that information until late December?

[Lord Bethell (Con)]

The noble Baroness is entirely right that the EpiData showed that the figures shot up in December; that is exactly why we looked extremely carefully at the genomic data from Kent and other places. As she knows, genomic data takes time to process—the tests can take a week to turn around. Looking at all the variants and matching EpiData figures with genomic data is an enormously complicated mathematical task. We moved as swiftly as possible and far faster than in many other countries.

[Lord Farmer (Con)]

My Lords, at the Downing Street press conference of 5 January, we were told that people had protection from the new variant if they had already been infected. What is the Government’s estimate of the number of people in the UK who now have antibodies after contracting the virus and are therefore likely to be immune? What is their approach to the large population of such people, estimated by Professor Neil Ferguson to be at 25% to 30% in London, and their need for vaccination?

[Lord Bethell (Con)]

My Lords, PHE weekly seroprevalence data suggests that antibody prevalence among blood donors aged 16-plus in England is 6.9%, which is consistent with other data that we have. The MHRA has considered this and has decided that vaccinating is just as important for those who have had Covid-19 as it is for those who have not.

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

How are demographic and NHS outcome data and test results from patients across the UK being collated to identify patterns suggesting further new variants, reinfections, changes in risk factors to severe disease, such as malnutrition, and planning for managing long Covid and modelling ICU provision?

[Lord Bethell (Con)]

The noble Baroness alludes to a world of analytical complexity, which is very much what we have to look forward to. The way in which this new variant has popped up and has been dramatically more transmissible presents a wholly different level of threat compared with the one that we were dealing with just six weeks ago. It is a matter of grave concern to all of us that this mutation has happened. However, I reassure noble Lords that we have very strong genomic capability in this country. Roughly 5% of all tests are analysed. It is only 5% but that is more than in most other countries, and we are putting in the analytical muscle to be able to process that data.

[Baroness Thornton (Lab) [V]]

My Lords, we are of course facing a terrible and very serious infection, so are the Government contemplating further restrictions? If so, when will we know that there are going to be further restrictions? It seems to me that the ones we have right now are not working.

[Lord Bethell (Con)]

My Lords, the decisions about further restrictions in this country are a cross-departmental matter and are, frankly, above my pay grade. To address the noble Baroness’s point directly, the new variant is a very serious matter. It is as though a turbocharger has been attached to the engine of a high-performance car, which is going round the racetrack faster and faster. This mutation is very similar to ones in South Africa and Brazil, and, experts assess, will happen in many places around the world. We are now dealing with a significantly different virus and we have to adapt our reaction to it accordingly.

[Baroness Bowles of Berkhamsted (LD) [V]]

As part of the science, mathematicians run numbers on the spread of variants in an attempt to see whether one is getting an edge; these saw the new variant gaining in the east of England and London by November. Why did a significant localised increase in one variant not trigger an immediate precautionary response, rather than prevarication that it might be about behaviour? What evidence is there that behaviour can favour one variant over another?

[Lord Bethell (Con)]

I am terribly sorry but the noble Baroness is not right about that chronology. Through backward tracing and by looking at historic data, we were able to identify that the variant had been present in Kent as far back as September, but it was only through backward tracing that we were able to figure that out. Further analysis was commissioned on 18 December and NERVTAG concluded that the variant was much more transmissible than others in circulation. Before that, we relied on hunches. When the science changed, so did our decisions.

[Lord Truscott (Ind Lab) [V]]

Andrew Miller, president of the Australian Medical Association in Western Australia, said:

“Until we get more data that shows that AstraZeneca is as good as the others, the scientific and medical risk that you take is that you won’t get herd immunity. The political risk is that you will get a good vaccine for the rich and a not so good vaccine for the poor.”


Is it not just a fact that the AstraZeneca vaccine is better than nothing but it will not stop the pandemic—especially the new variant?

[Lord Bethell (Con)]

I categorically reject that analysis. All the vaccines are effective. The MHRA and the JCVI have been explicit about that, and I invite the noble Lord to look at the data.

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

My Lords, my noble friend rightly underlines that new variants are appearing not just here but anywhere in the world. Can he explain the process for notifying such variants worldwide and say how any assessment of their characteristics is passed on?

[Lord Bethell (Con)]

My noble friend asks a very challenging question. The honest truth is that we have to look at the systems whereby that data is exchanged. CMOs around the world have extremely regular contact with each other, and a lot of the data is exchanged through the formal links of the scientific community. But I think that there is a case for more structured intergovernmental exchange of data about the new variants, because this will be the major challenge of the year ahead.

[Viscount Waverley (CB)]

The Minister mentioned a number of countries. Is there sufficient exchange between all of them or could more be done in that regard? Is there anything that the public could usefully know about the new variant’s transmission traits—whether it is airborne, for example?

[Lord Bethell (Con)]

The exchange of information between the scientific community has worked extremely well during this pandemic and epidemic, and I pay tribute to it for the open-hearted and transparent way in which it has exchanged data across political, cultural and national boundaries. In terms of transmission, the noble Viscount alludes to something that is very difficult to pin down. It is not clear what proportion of the disease is transmitted through the air and what proportion by touch and manual transmissibility. That is a very frustrating conundrum. The CMO guides us to believe that there is more transmissibility through the air than by touch, but it is absolutely essential that people keep their distance and wash their hands.

[The Lord Speaker (Lord Fowler)]

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

Covid-19: Vaccinations

Lord Bethell Excerpts

Wednesday 13th January 2021 Lords Chamber

[Baroness Brinton (LD) [V]]

My Lords, I welcome this Statement on the on the vaccine strategy and rollout, which we have been asking for from these Benches, in both Houses, since before the first lockdown. The Government have rightly set themselves stretching targets and we agree with them, especially in the light of the new variant’s high levels of transmission. The news this week of the severe problems that our NHS is facing across the country shows how out of control the virus is at the moment. Individuals must comply with the spirit and the rules of lockdown to help to reduce cases as soon as possible.

The Prime Minister has talked repeatedly about a vaccine signalling the end of the pandemic. I fear that lax messaging about the hope that vaccines bring is hampering the message about lockdown. It is a relief to hear in this Statement a more measured tone about this being a staging post in a long journey. Please can somebody tell the Prime Minister? The Minister will know that epidemiologists repeatedly make the point that we are a long way from life returning to normal. I note, for example, that in the debate about the vaccination priority list, the advice to clinically vulnerable people from government is that, even after their vaccine, they must remain shielding until told that it is safe for them not to shield.

On supply, we remain concerned that the Government will struggle to reach 2 million a week by next week—mid-January—given the numbers of vaccines being delivered this week. We are also receiving reports from GP surgeries of fewer doses arriving than ordered or, worse, short-notice cancellation of orders causing administrative chaos for already hard-pressed administrative surgery staff. While the opening of super vaccine hubs is welcome, can the Minister say why the hubs are vaccinating only during the day? If it is truly a priority to vaccinate as many people as possible, arrangements should be made for close to 24/7 delivery. I hear that, in the last hour, the Prime Minister has announced that the Government will try to start a pilot of some 24/7 hubs as soon as supplies permit—but how soon is soon? What are the vaccine supply pinch points? It is clear that targets are already slipping. This week, the target of 2 million a week has moved from mid-January to the end of January, and it is now the end of March instead of the end of February for the top five priority groups. Is this for the supply of all three approved vaccines, or just the AZ vaccine, where there is a much larger order to be rolled out with more substantial delays if there are supply pinch points? Also, it is because of a shortage of glass vials, or vaccine manufacture and regulation checks?

What are the Government doing to ensure that vaccine hubs are not superspreader locations? There have been worrying reports about people being asked to change masks and sit and wait less than two metres away from other people in the vaccine hubs. Given that the first five priority groups are all high-risk people, the last thing the NHS should be doing is encouraging them to go to areas that do not follow the government guidance on “hands, face, space”. Inevitably, there are glitches with any new process. We are still hearing of problems with the Pinnacle IT system that is being used for vaccinations. Some hubs were resorting to pen and paper in despair, and there are further problems reported with patients being asked to give the same detailed answers to a group of questions about Covid symptoms and allergies as they arrived, as they were registered and then as they were being given their jab. Any effective IT system should enter that information once. IT delays are reported as causing major delays, queues outside centres and daily targets missed at hubs. Can the Minister say what is being done to remedy these problems?

Can the Minister also say whether the vaccine dashboard will separate out the number of care home residents vaccinated? I see that care home cases are increasing again, which we deplore. As earlier this year, we strongly object to Covid patients being sent from hospitals into care homes, unless they are specialist Covid-designated units separated from other non-Covid residents. Even better would be to follow the example of Southampton hospital, which is using local hotels as step-down facilities. Will the Government endorse this and ensure that care home patients are kept safe through this surge until they are vaccinated?

The Government have announced that fewer than 1,300 surgeries and pharmacies are approved to deliver vaccines. The large hubs are all in urban areas. What will the Government do in rural areas, where elderly people do not have access to transport and may have to travel considerably further than the 90-minute journey for vaccinations announced this week? Are there plans as yet unannounced to increase substantially truly local-level provision, at a high-street level, in every rural village and small town—whether at a local surgery, pharmacy or visiting mobile vaccination unit—to ensure that vulnerable people who cannot travel or take the risk of infection will get access to the vaccine? It is not good enough for the Government to say that vaccines have been offered if the patients concerned cannot get to the vaccination delivery point.

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

My Lords, I am enormously grateful for the detailed questions from the noble Baronesses. In particular, I endorse the words of the noble Baroness, Lady Thornton: it is indeed a remarkable achievement to have invested in such a broad array of candidates and to have purchased such an enormous quantity of doses—367 million. This is indeed a profoundly important step by the Government and one that we should celebrate and take pride in.

However, I acknowledge the searching questions from the noble Baronesses, so let me try to cover as much ground as I possibly can. The noble Baroness, Lady Thornton, asked about the digital backbone. This is absolutely critical to vaccine delivery. In many ways, injecting it into arms is the simple bit. Capturing the records, getting the invitations out right and the process of establishing identity are absolutely critical; in any project of this scale and complexity, that is where the problems are most likely to happen. That is why I pay tribute to colleagues at NHSX, NHS D, Test and Trace, PHE and elsewhere in the NHS who have done an amazing job of bringing together patient records around the nation to ensure that the invitations are sent out promptly and accurately and that the records are captured correctly. That information will be absolutely essential to both pharmacovigilance and the policy assessment of key issues such as transmissibility and efficacy. It employs the yellow card system to spot adverse incidents, and all data will go straight into the GP record, which is profoundly important when it comes to the research and analysis of the rollout of the vaccine. These may seem like prosaic details, but it is the most enormous digital achievement and one that will have an amazing impact on the health of the nation. I enormously encourage everyone in the country to ensure that they know their GP number, that they are properly registered with their GP and that they respond to any correspondence about the vaccine.

The noble Baroness, Lady Thornton, characterised the vaccine rollout as “traditional”. Can I just push back gently on that suggestion? There is nothing traditional about the sheer scale of this rollout, or about its speed and complexity. Our approach has been to work through the NHS, and from that point of view it might seem traditional, but I reassure noble Lords that not only is the latest technology being used but there is also the complexity of the collaboration between all the different parts of government—the Army, the NHS and PHE. Every single relevant part of government is being employed in this huge task, and it is something we should be enormously proud of.

The noble Baroness, Lady Thornton, asked about the supply figures. I am pleased to tell her that AstraZeneca has confirmed that it will be supplying 2 million vaccines a week. That is an enormous sum and it will mean that we can hit some really ambitious targets. Some 14.5 million people will be vaccinated by mid-February. Those are in categories 1 to 4, which includes care home residents and residential care workers, and they represent 88% of the mortalities in hospital. That will be transformational to the resilience of our healthcare system and to our approach to the pandemic. Some 17 million further people from categories 5 to 9 will be vaccinated by the end of spring, and all adults over 18—52 million of them—will be offered the vaccine by the autumn. That is a massive achievement.

The noble Baroness, Lady Brinton, quite rightly emphasised that this does not change absolutely everything overnight. She asked, quite reasonably, about schools and workplaces. I can confirm that there is still a huge amount to do by the entire nation to ensure that we do not have high infection rates, that we still deploy testing in order to break the chains of transmission and that we understand how to keep infection down—because the tragic thing about this awful virus is that it hits the old and infirm, who can be protected by the vaccine, but it also hits the young. It has become very clear from recent hospital admissions and from our growing understanding of long Covid that this disease hits all parts of society, and although we will have the most afflicted vaccinated by the spring, this is still going to be a societal challenge for months to come.

The noble Baroness, Lady Brinton, mentioned the letters to those shielding, which suggest that people should still remain shielded. That is a really important point and one we have to resolve, because those who are shielded who may go out into the community can themselves still be vectors of transmission. Those very people who we have done so much to protect may themselves be transmissible. Therefore, people are going from being protected to being potentially dangerous to others, and this is going to be a mind shift that we will all have to go through.

The noble Baroness, Lady Brinton, asked about GP surgeries. I acknowledge her point. There have undoubtedly been stories of GP surgeries which have set up queues of people to be vaccinated and then there has not been a delivery of the vaccine. However, I reassure the Chamber that it has been a very small minority. More than 95% of vaccination deliveries have happened on time, and in the grand scheme of things I take the view that if some GP surgeries have stood people up and asked them to come back another time, that is a small price to pay to ensure that the greatest number of people can be vaccinated as fast as possible.

The noble Baroness, Lady Thornton, asked about London. It is true that if we look at the infection rate, London has a relatively small distribution of the vaccine, but we are a young city here in London, so it makes sense that we have a lower proportion of vaccination. There are 2.8 million people who are more than 80 years old in the country. Not many of them are found in London, which is why the London figures look as they do.

On pharmacies, I reassure all noble Lords who have asked me about this that my colleague in the other place, Nadhim Zahawi, is incredibly energetic in engaging pharmacy chains and community pharmacies. It is true that we have a pilot with hundreds of pharmacies already running in it, but it is very much our intention to work closely with pharmacies to deploy the vaccine. As noble Lords know, vaccines come in plates of 1,000. It is much easier to deploy those plates in large centres than in small ones. We are working extremely hard to break those packages down into smaller groups and to get those groups into smaller locations but, quite reasonably, in order to get the vaccine into the most arms possible, we are starting with the big centres.

The noble Baroness, Lady Brinton, asked me about hygiene management in the distribution of the vaccine. She is entirely right: if you have a small room, such as a GP surgery, and you have a large queue of people, it is going to be extremely difficult to keep them all separated. That is why the development of these seven massive distribution centres in such places as the ExCel and Millennium Point in Birmingham is such an important development, because there is the space to be able to move very large numbers of people safely through the process. They will have a huge impact when they are opened next week.

On 24/7 vaccination, I am pleased to say that the Prime Minister has made an announcement on that. I must share with noble Lords that there has not been an overwhelming consumer demand for vaccinations at 4 am, but we are going to try this out as a process, and if there is indeed a big demand for late-night vaccination, then we will step up to the opportunity.

I was asked about rural distribution. Yes, it is incredibly important to get through to rural communities, particularly as many of the elderly and infirm can be found outside the city centres. I reassure noble Lords that, before very long, we will have vaccination centres within 10 miles of all communities. The noble Baroness, Lady Brinton, is entirely right to say that there will be some people for whom we have to take the vaccination to them; we cannot expect them all to drive to a vaccine centre. Provisions are being made through local health authorities in order to ensure that that is delivered.

[The Deputy Speaker (Lord Duncan of Springbank) (Con)]

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

[Lord Blencathra (Con)]

My Lords, will my noble friend accept my congratulations? The Government have done an absolutely magnificent job on vaccinations. They bought more than enough of the right vaccine, approved it first in the world, injected it first in the world and have vaccinated more people than the whole of Europe put together. I hope the Government will now not be distracted by some of the pathetic media trivia we have heard about how far you can ride a bike, whether a Scotch egg is a meal, whether it is 2 metres or 3 metres, or tier 3 or 4, or whether things have been too fast or too slow. Does my noble friend agree that the only thing that matters now is vaccinating all our people, in the whole of the United Kingdom, as quickly as possible—and 24/7 if vaccine supplies permit—to build on the success we have had so far?

[Lord Bethell (Con)]

My Lords, I am enormously grateful for my noble friend’s kind words. I think that, as a Government, we would prefer to be judged at the third act of this important performance, so I think it is probably too early to take too much praise, but I would like to say a massive thanks to the British nation.

In three ways, the nation has really stood up. The amount of collaboration between different groups—I alluded to it in my previous answer—between the Army, industry, the NHS and local authorities has been enormous. At the beginning of this pandemic, there were arthritic elements to the way in which Britain is governed that meant that different parts of our political and administrative machinery did grind into action slightly slowly, but, my goodness, over the vaccine deployment it has been absolutely athletic, and I take my hat off to every part of the machinery of government. On the union, this has been such a strong example of a national solution: all of Britain has come together in order to purchase and deploy the vaccine. Lastly, I would observe the resilience of the British public. It makes me enormously proud that the country puts the elderly and the infirm first and stands by and celebrates the weakest and most vulnerable in our society being put first in the queue. That is a national quality we should all be proud of.

[Lord Crisp (CB) [V]]

My Lords, I congratulate everyone concerned in the progress being made with the vaccinations, while recognising that there are issues to be addressed, not least that of accelerating the whole process. In passing, I note that I would be very happy to be vaccinated at 4 am if it sped things up. I will ask about testing and vaccination for a particularly vulnerable group; children excluded from school are the among the most vulnerable in the country, and I pay tribute to the approved alternative education providers and others working with them during the pandemic. I have been contacted by one of the directors of one of these providers, who tells me that, unlike schools, they are not being provided with lateral flow tests to help them protect children in school and staff. If I write to the Minister, will he take the matter up? Can he ensure that all such approved providers receive the tests and that their staff are given a high priority for vaccination—at least as high as that for teachers?

[Lord Bethell (Con)]

I am grateful to the noble Lord for flagging this important issue. He is entirely right that those who are sometimes overlooked by society and fall between the cracks are often those who either suffer from the disease or are vectors of infection. It is a public health priority to ensure that people such as those excluded from schools are not overlooked or in any way left behind. I would be very grateful if he could write to me with the details.

[Lord Winston (Lab) [V]]

My Lords, speaking from these Benches, I think it would be appropriate to thank the noble Lord, Lord Bethell, very much for the amazing amount of work he has been doing on this very difficult issue. I hope he will continue to take our concerns back to the Department of Health and the Government in general, because that seems very important. I join my noble friend Lady Thornton in congratulating the Government on getting vaccines out, but, with all due respect, Israel has already vaccinated over one-fifth of its population with a massive vaccine campaign. On the important issue of dividing the time of the Pfizer vaccine, many of us have given informed consent for a period of three weeks between the two injections; by extending that period, we now risk not obeying the consent issue, and therefore there is an ethical problem. Could the noble Lord address that issue, because it is of considerable importance, certainly increasing the risk of suspicion of the vaccine, already very prevalent in parts of the population?

[Lord Bethell (Con)]

I am extremely grateful for the noble Lord’s kind words. I know lawyers looked at the question he raises on informed consent; I am afraid I do not have the precise answer at the Dispatch Box right now, but I will be glad to write to him with a clarification.

[Lord Scriven (LD) [V]]

Up here in the north, the Yorkshire Post is running a “shot in the arm” campaign to get the Government urgently to allow the local community pharmacists who are screaming out to get jabs in people’s arms to do so. Why are the Government using excuses about batches of 1,000 for the AstraZeneca vaccine getting in the way of using these safe places on the high street that will improve access in the take-up of the vaccine?

[Lord Bethell (Con)]

My Lords, I am not sure we are using excuses; we are observing practical matters. The priority, quite reasonably, is to get the vaccine in as many arms as possible. We are totally committed to comprehensive distribution of the vaccine that reaches into rural communities and will include working with community pharmacies as important distributors. However, be under no illusion: our priority is speed and reach, which is why the deployment has taken the shape it has.

[Lord Lancaster of Kimbolton (Con)]

My Lords, my noble friend Lord Blencathra hits the nail on the head. I add my thanks for the support of the military—my noble friend the Minister will forgive me if I sound like a pedant, but it is not just the Army but also the Royal Navy and the Royal Air Force. However, their support is ultimately unsustainable. Yesterday the Defence Secretary suggested that the NHS should create a reserve of its own. We are certainly not short of volunteers, given the response to the call to arms last year, so is the Minister considering it?

[Lord Bethell (Con)]

My Lords, my noble friend rightly picks me up on my use of words. I profoundly thank all those in the armed services who have made a contribution. They bring particular qualities to such a challenge as the deployment of the vaccine: logistical analysis and project management of the highest level, and the manpower and ability to get things done quickly on the front line. Those are extremely complementary. However, be under no illusion; there are 1.3 million employees in the NHS, and far fewer in the Armed Forces. There is no question of the Armed Forces being able either to replicate or take the role of the NHS in such a large project, though we are enormously grateful for their particular contribution. One lesson of the pandemic has been the remarkable return to work of former NHS workers and the early graduation of some trainees. We should and will look at the use of volunteers in the NHS in months to come.

[Lord Loomba (CB) [V]]

My Lords, the Government’s action plan for the rollout of the vaccine is commendable, with over 2.5 million doses given to date. One issue now appearing is that there are a good many no-shows at vaccine hubs. In an effort not to waste the vaccine, which has a short shelf life, administrators are finding as many people in close proximity as possible to give the unused doses to. While not wasting valuable doses is admirable, does the Minister agree that some back-up system should be in place to ensure that those who need it most are able to get it first when there are so many no-shows daily? Secondly, does he agree that parliamentarians in both Houses should be on a priority list for vaccination?

[Lord Bethell (Con)]

My Lords, no-shows are being managed extremely effectively under the current arrangements. We are extremely grateful to the British public for their perseverance.

[Lord Faulkner of Worcester (Lab)]

My Lords, I am happy to join others in congratulating the Minister on how he has delivered news about the vaccines to your Lordships’ House and to everybody concerned with the rollout. I wish it well in every possible respect. However, I am sure he will agree that, as it will take a little while before the vaccine has the beneficial consequences we want, it is essential that we do not drop our guard now. In that context, I return to a subject I asked him about two weeks ago: the mandatory wearing of face coverings. I asked him then what guidance the Government could give to public-spirited people who try to encourage others who are not wearing face masks in places such as shops and on public transport about whether they are right to do so? Can he give some comfort to those of us who want to intervene but are frankly deterred by the reaction we are likely to get? It is good news that the supermarkets are operating a new policy, and I welcome the announcement by the Metropolitan Police Commissioner. I would like a bit of a lead from the Government as well.

[Lord Bethell (Con)]

The noble Lord is entirely right. The advent of the new variant, with its extremely high transmissibility, means that we all have to rethink our approach to the pandemic. We must all adopt habits that are uncomfortable and frustrating, of which mask-wearing is one good example. I know that colleagues in government are looking at ways in which restrictions should be refined. The Government do not take a view on intervening with members of the public; it is the personal responsibility of individuals to make decisions for themselves. The police certainly have very clear guidance on what interventions they should make, and it is best to leave it to them.

[Baroness Jolly (LD) [V]]

My Lords, the scale of this rollout is truly impressive, and I join others in congratulating all those who have actually made it work in such a short time span. I live in a very rural area on the edge of Bodmin Moor. My local satellite surgery has closed because it cannot be made Covid secure, and the vaccination site is 18 miles away with no public transport connections. Would it be possible for older people who cannot get to the vaccination site to be vaccinated by a different practice, which is only five miles away by bus but in the other direction?

[Lord Bethell (Con)]

The short answer is yes, and absolutely. The noble Baroness makes a point that we understand vividly and extremely well. Many smaller GP surgeries simply are not physically capable of being Covid secure, as she rightly points out. We are taking a panoptic view of health records to ensure that the right GP surgeries which are open can offer the service to those who would not normally be reached.

[Lord Fairfax of Cameron (Con) [V]]

My Lords, I would like to ask my noble friend the Minister two questions, if I may. Like many others, I first congratulate him and the Government on the progress made so far with the vaccination programme. But what plans do they have to further turbo-charge the vaccine deployment programme? I am, of course, thinking of a 24/7 vaccine centre, as many others have referred to already. Reference has also been made to Israel’s much greater progress, so far. But is the Minister aware of the comment of the highly respected Professor Bell of Oxford, who said that we could vaccinate the whole country “in five days” if we had the will, subject, of course, to supplies of the vaccine? Professor Bell went on to say that this vaccine rollout is a “war” and should be treated as such by the Government. Therefore—in my respectful submission—to refer to consumer demand is not necessarily consistent with that status of war. On my second question, the Government have said that they expect all nine high-risk groups to be vaccinated “by the spring”. Can the Minister tell us what exactly the Government mean by the spring—in other words, months and days or dates?

[Lord Bethell (Con)]

My Lords, on turbo-charging the vaccine deployment, the two key focuses are: first, on very large centres, which can have a very large throughput of people, as these will make an enormous difference and bring an industrial energy to the process; and, secondly, to extend the reach into the hard-to-reach communities, whether those are rural or where people are not in the mainstream of British life. Regarding the noble Lord’s point on the “war”, while it might seem obvious to him that everyone will step forward for the vaccine that is not, strictly speaking, right. Some people are going to make careful decisions before stepping forward to have it, so we have to think about making it attractive and reasonable to as many people as possible, particularly those who are vulnerable to the disease. I do not think it is right that we cannot have a consumer mentality to this. We have to treat the public with consideration and thoughtfulness, because they will decide whether they are going to step forward or not.

[The Deputy Speaker (Baroness Morris of Bolton) (Con)]

I now call the noble Baroness, Lady Meacher. Lady Meacher?

[Baroness Meacher (CB) [V]]

Sorry, I could not get myself unmuted. My Lords, as a Covid sufferer, which I am, I too applaud the Government’s amazing vaccination programme. I just have a few points of clarification. First, when the Government talk about offering a vaccination to all four top vulnerability groups by mid-February, do they mean all those groups will have a vaccination by mid-February or an invitation for one, which, of course, could be for a vaccination in March or April? Secondly, is there any progress yet on bringing forward the second vaccination—we are talking about the country here—from the 12-week point, bearing in mind the greater risk of mutations while we have this rather long wait between first and second vaccinations? Thirdly, if I may, can the Minister contradict the anti-vax story, which I regard as very dangerous, that the vaccinations contain polyethylene glycol which could be dangerous for allergic people? These stories just have to be crushed, if we can.

[Lord Bethell (Con)]

My Lords, the four priority groups that the noble Baroness alludes to are: care home residents; residential care workers; the 80-plus; healthcare workers; social care workers; 75 to 79 year-olds; 70 to 74 year-olds; and the clinically extremely vulnerable. It is a huge proportion of those who are most vulnerable to the disease. We can only offer people a vaccine; we cannot force them to have it. Certainly they will be offered it, but the encouraging news is that a very large proportion of people seem to be stepping forward, and attitudes towards the vaccine so far seem to be extremely positive. I reassure all those who have seen anti-vax messages that this is not something that those with allergies should be frightened of. On the second dose, the MHRA has been clear that there is no evidence that the current round of mutations we have seen has any impact on the vaccine, and that it in no way increases the need for an accelerated second dose.

[Viscount Younger of Leckie (Con)]

My Lords, I would urge speakers to keep their questions short—one question, please—to allow all speakers to contribute.

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

My Lords, based on the scientific and medical evidence, which undoubtedly will be gathered throughout this vaccination process, can the Minister indicate if there will be annual rollouts of the vaccination programme from 2022 onwards?

[Lord Bethell (Con)]

My Lords, I cannot look into the future with that much clarity, but the noble Baroness raises a possibility that surely must be accounted for. It is possible that this kind of coronavirus may mutate; it may need to be managed, as we do other flus. It is too early to make that call but that is the kind of thinking that goes into the development of the NIHP—the new National Institute for Health Protection.

[Lord Rooker (Lab) [V]]

My Lords, I declare an interest as someone who is shielding. I too congratulate everybody involved in the vaccine project. The Minister alluded to the targets; I have to assume that we are going to vaccinate 350,000 today, so that we can maintain the target. That is really important. On the rural aspect, I live in Shropshire. Those who run Shropshire live in the north and tend to forget south Shropshire, so the issue of rural vaccination is pretty crucial. But can I make one final point relating to the point that my noble friend Lord Winston raised earlier on? I am in a position to ask the Minister a question today only because I gave my informed consent on three or four occasions in the last 12 months. I did not look on that as a specific performance contract by the NHS; I looked on it as allowing the NHS to do things to my body to help me survive. If they come along and change their opinion about the way they want you to survive, we should go along with their advice.

[Lord Bethell (Con)]

The noble Lord makes the point extremely well, and I agree.

[Baroness Sheehan (LD) [V]]

My Lords, no one is safe until everyone is safe. Does the Minister agree? If so, what thought have the Government given to supporting the temporary TRIPS waiver proposal by South Africa and India, given that it will help the WHO’s efforts to co-ordinate the local supply of vaccines through its C-TAP initiative?

[Lord Bethell (Con)]

My Lords, I would put the truism slightly differently: the vaccine makes you pretty safe, but it does not mean you are not dangerous to other people. I think we all have to get used to that. Regarding the South African variant and the other variants popping up in Brazil and elsewhere, this is a manifestly different disease that is growing up around the world. It has a huge implication for international travel. We are working with the WHO and other groups to try to understand this, but it is certainly of grave concern to the country.

[Lord Farmer (Con)]

My Lords, I join many others in applauding the Minister and the Government on their vaccination energy and foresight, and for being leaders in the world, frankly. Given the Minister’s zeal and energy, he informed the House on 30 November that the SIREN and Oxford healthcare workers studies would report on the level of sterilising immunity provided by natural infection before the end of 2020. Have they concluded that antibody protection can be relied upon for at least six months after infection, or longer, and what are the implications for herd immunity?

[Lord Bethell (Con)]

My Lords, the SIREN study is an important study on antibody protection. My understanding is that it is due to be published very soon indeed, and when it is, I will be glad to share the insight with my noble friend.

[Lord Walney (Non-Afl)]

Further to the question from the noble Baroness, Lady Richie, the Minister told your Lordships’ House yesterday that was there was a very real threat that a variant could start escaping the vaccine. In those circumstances, could there not be a need for a massive standing vaccination programme, far beyond the national flu jab scheme, and are the Government therefore making contingency plans for such a challenge?

[Lord Bethell (Con)]

That is a gruesome prospect and not one that I like to see in a debate like today’s, where there is so much positivity. However, the noble Lord is entirely right that mutations may go that way. The good news is that the current round of mutations that have been seen in Kent, South Africa and Brazil seem to be about transmissibility, not escapology. It is as though the car had driven into the pits and had a turbo attached to it, but not camouflage equipment. But that could happen, and if it did, we would indeed have to look at much more emphatic and systematic long-term vaccination programme.

[Baroness Altmann (Con) [V]]

My Lords, I too congratulate the Government and the Minister on all the tremendous work that has been done, especially on the vaccine. Can he say what the hold-up would be for a 24/7 programme, what the scale of supply is, and when a supply chain might be available that could deliver 24/7 vaccination? The scale of damage to other aspects of the health of our nation as well as to the economy is unsustainable. This is like a war effort but we absolutely need to be rolling out this vaccine as quickly as we possibly can.

[Lord Bethell (Con)]

My Lords, I completely hear my noble friend’s encouragement, and her advocacy on behalf of business and a return to normal is heard loud and clear. The deployment is happening literally as quickly as we can possibly make it. I suggest to her that even NHS workers have to sleep, they have families, and it is not possible to run operations through the night on a mass scale. You cannot force people to turn up for a vaccine. I am not sure that the idea that millions of people will turn up at 4 o’clock in the morning for a vaccine is entirely realistic. However, my noble friend’s point about scale and whether we can move faster and turn around the situation more quickly is extremely well made. I reassure her that we are doing everything we possibly can.

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

Will my noble friend join me in congratulating dispensing GPs in rural areas on hitting the main target group of over 80 year-olds? Can he confirm that the latest spike in care homes may be attributable to the fact that a second dose is not being administered within 21 days? Will he revert to that practice as far as possible and ensure that the same vaccine is given for the second dose?

[Lord Bethell (Con)]

I pay tribute to the role of dispensing GPs, who will play an incredibly important role in the rollout. However, I reject the suggestion that any spike in care homes is in any way related to decisions on the second dose. The new variant has spread throughout society, including care homes, and that is the explanation for the spike.

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

Can the Minister assure the House that the Government have a co-ordinated plan involving not just vaccination but improved test, trace, self-isolate and support, and flexing controls on commercial and social activity to reduce and control the levels of the virus over the coming weeks and months? Can he tell us when the Government plan to publish such a plan? Obviously, events will have an impact, but now that we have had a year of learning about the virus, surely the Government have an overall vision of how we as a nation will emerge from the pandemic, and it would help us all if that was shared with the nation.

[Lord Bethell (Con)]

The noble Baroness is right that we have the vaccine today but that does not mean that we will not need to be testing, distancing and washing tomorrow. In fact, there will be a very large number of people—tens of millions—who will not be vaccinated through the summer but who could still catch the disease. We have to make provisions for our public health to protect those people in the workplace, in society and in their homes. The plan is very clear—it is the plan that we have already. However, the noble Baroness is right that we have to be focused on it and ensure it is kept up to date and deployed with energy and enthusiasm.

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

I thank my noble friend for his assiduous and clear briefing to the House. Can he thank those who have already delivered vaccines to our overseas territories? Perhaps in due course he can let me have details of what has been delivered to individual OTs and the plans for the coming weeks.

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[Lord Bethell (Con)]

I pay tribute to colleagues in the FCDO, which has been a tremendous advocate for overseas territories. We have made considerable provisions to ensure that vaccine supplies are provided to the far-flung territories, where we have strong relationships and a duty of care. I would be glad to write to him with the details of that deployment.

[Baroness Uddin (Non-Afl)]

My Lords, anyone questioning the horror of the disease and the pressures on the NHS need look no further than outside their local hospitals, as I did, notwithstanding that questions on efficacy, information and choices are the fundamental right of every patient. The Minister will know that the Bangladeshi community has a very high vaccination compliance rate, but in this case there has been quite a lot of confusion. Can he yet again confirm that sufficient bilingual material is being made available to the community, and will he agree to meet with me and some experts on this issue?

[Lord Bethell (Con)]

My Lords, that is a very good reminder. I will be glad to return to the department and check that the bilingual material is as she asks, and I will write to her with the details.

[Lord Mann (Non-Afl) [V]]

My Lords, the NHS has been put in charge of this and is delivering big time, and everyone I speak to is delighted about the way the rollout is going. When we move into the next phase, will workplaces be targeted, so that they are able to do their own logistics and get thousands done at a time, quickly, cheaply and easily?

[Lord Bethell (Con)]

My Lords, that is a decision for the NHS deployment team. I do not know the precise answer but frankly, based on experience I would guess that NHS environments are probably the focus for the deployment—that the focus is on where NHS staff can have safe, hygienic environments, rather than on workplaces. However, I will take the noble Lord’s idea back to the department and write to him to see whether that is being considered.

[The Deputy Speaker (Baroness Morris of Bolton) (Con)]

My Lords, all questions have been asked.

Medicines and Medical Devices Bill

Lord Bethell Excerpts

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

Moved by

[Lord Bethell]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[Baroness Cumberlege (Con) [V]]

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

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[Baroness Thornton (Lab)]

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

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

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

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

[Lord Bethell (Con)]

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

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

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

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

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

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

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

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

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

“any other person the Commissioner thinks appropriate”.

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

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[Baroness Cumberlege (Con) [V]]

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

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

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

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

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

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

[Lord Bethell (Con)]

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

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

Amendment 1 agreed.

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[Baroness Jolly (LD) [V]]

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

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

[Lord Bethell (Con)]

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

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

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

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

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

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

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

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

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

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

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

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

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

[Baroness Thornton (Lab)]

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

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

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

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

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[Baroness Thornton (Lab)]

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

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

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

[Lord Bethell (Con)]

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

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Moved by

[Lord Bethell]

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

[Lord Bethell (Con)]

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

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

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

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

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

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

“the health and safety of the public”.

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

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

Among others, my noble friend Lady Cumberlege, the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Thornton, made salient points about the importance of safety. While there has never been any intention that making the UK attractive to the life sciences sector should make patients less safe, we have provided for a clear and unambiguous lock on patient safety—that is, as part of the decision-making process behind regulatory changes, if proposed changes have an impact on the safety of human medicines, the appropriate authority may make those changes only if the benefits outweigh the risks.

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

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

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

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

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

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

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[Lord Bethell (Con)]

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

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

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

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

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

[Baroness Thornton (Lab)]

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

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Moved by

[Lord Bethell]

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

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[Baroness Thornton (Lab)]

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

[Lord Bethell (Con)]

My Lords, I am enormously grateful for that helpful debate. Let me try to provide some of the clarity and reassurances noble Lords have sought. Amendment 14 to Clause 3 would add constraints to the use of data collected as part of the operation of any national falsified medicines scheme. I understand that the intention of Amendment 14, in the name of the noble Lord, Lord Clement-Jones, is to prevent the use of data collected for any additional use other than for the purpose of ensuring patient safety. We discussed this at length in Committee and afterwards, and I am grateful to the noble Lord and to other noble Lords who have given up their time to discuss this important issue. I know that the noble Lord has returned to this because he thinks it is worth continued debate, so I would like to reassure him that we have thought very carefully indeed about the power in Clause 3(1)(b).

I will start with the context of the power to use information collected as part of any potential future national falsified medicines scheme. First, it is important to note that the overarching principles of the Bill set out in Clause 1 also apply to, and are constrained by, the powers in Clause 3.

Amendment 4 in my name would ensure that in making regulatory changes under Clause 3—not just around how information will be used—the appropriate authority’s overarching objective must be safeguarding public health. In making that assessment, one of the things the appropriate authority must have regard to is the safety of medicines. Further, we have provided for a clear and unambiguous lock on patient safety; that is, as part of the decision-making process behind regulatory changes, if proposed changes have an impact on the safety of human medicines, the appropriate authority may make those changes only if the benefits outweigh the risks.

Secondly, of course, any regulations providing a framework for the use of the information will be subject to parliamentary scrutiny under the draft affirmative procedure. So, the scope of Clause 3(1)(b), which is the focus of our discussion, is not unfettered. I have discussed previously the statutory requirement to consult before making regulatory changes. Powers at Clause 3(1)(a), (2) and (3) will provide us with the means to make the regulatory changes to establish a verification system, if appropriate. As part of the effective operation of any such system, information will need to be collected. It is only once we have established the need for a verification system, and how it could work, that we can fully consider how the information it collects could be used to deliver additional benefits for the UK and for patients. Clause 3(1)(b) and (3) enable us to make appropriate best use of the data collected as part of a national focused scheme and ensure that the appropriate authority must have regard to the importance of ensuring that information is retained securely.

I want to reassure noble Lords by being as clear as I can that the data in question is that which would be collected for the prevention of the supply of falsified medicines—that is, as part of the operation of any verification scheme. I reassure noble Lords that we could not expand the data being collected using Clause 3(1)(b) as part of a verification scheme. However, we want to maximise the use of data collected as part of any verification scheme where it is in the public interest. In this, we would be learning from the EU scheme, which, for example, allows data to be used beyond patient safety for reimbursement purposes and in delivering a solution that works at a national level. I reassure the Chamber by being as clear as I can be that the powers in Clause 3 do not include the collection of patient data. As with the current European scheme, there are no plans for any future national falsified medicines system to collect patient data.

My concern is that putting such a limit on the use of information at this time could constrain or limit options ahead of our engagement with stakeholders. Critically, it may not allow for the data to be used for all potential research purposes. We are not in a position at this moment, ahead of our engagement with stakeholders, to list all the potential ways in which data sources might be combined for research and wider public health purposes, which can go beyond patient safety. We want to be guided by our stakeholder engagement and not to restrict that process unnecessarily before we have had a chance to hear how this data could be used for public interest purposes.

We are also proposing a staged approach to engagement and consultation. We are committing to a clear and separate consultation and engagement: first, a consultation around the need for and details of any system concerned with the prevention of falsified medicines; and secondly, a specific consultation around other uses of the data collected under Clause 3(1)(b). As I have said, any regulatory changes that will provide a framework for the use of the information would be subject to parliamentary scrutiny under the draft affirmative procedure.

I believe that by developing these proposals through consultation and engagement, we are improving our policy-making and its subsequent implementation. I remind the House that we have no scope for changing these provisions at Third Reading, so if the noble Lord, Lord Clement-Jones, wants to press the matter, he will need to do that today, but I hope instead that he will have had enough clarity and reassurances from the Dispatch Box to be able to withdraw his amendment.

[Lord Clement-Jones (LD) [V]]

I thank my noble friend Lady Jolly, the noble Lord, Lord Hunt, and the noble Baroness, Lady Thornton, for their helpful contributions and support today. I also thank the Minister for his reply; I regard it as something of a curate’s egg, but I recognise the thought that has gone into it, particularly his statement on the overarching principles in Clause 1 governing Clause 3 and the fact that the benefits must outweigh the risks in any scheme. He talked about the affirmative procedure; I very much hope that we will retain the super-affirmative procedure, which encourages me that there will be greater scrutiny of any new framework.

The Minister also spoke about the statutory duty to consult on proposals and the duty to secure data. He said that no patient data was being used and that, at the end of the day, the essence of this is to maximise the use of data where it is in the public interest. He gave research as an example that might be outside patient safety—I doubt it, but he thought it might be interpreted as going beyond patient safety. I was very struck by the noble Baroness, Lady Thornton, saying that there was an element in this of having a power that might come in useful; indeed, the Minister almost repeated that in saying, “We’ll see what data we have collected.”

I take some comfort from what the Minister has said. We have had some very productive debates and some important amendments secured, so I will not press this amendment today. However, the noble Lord probably has to suffer the potential of being immortalised on a Pepper v Hart basis if there is any subsequent dispute about the width of regulations made under this clause and whether Clause 1 limits the scope of Clause 3. I am sure he looks forward to that. In the meantime, I beg leave to withdraw my amendment.

Covid-19: Vaccine

Lord Bethell Excerpts

Tuesday 12th January 2021 Lords Chamber

[Baroness Deech]

To ask Her Majesty’s Government what evidence they have that delaying a second dose of the Pfizer-BioNTech Covid-19 vaccine will not (1) diminish its effectiveness, or (2) cause further mutations in the virus.

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

My Lords, the views of the MHRA and the JCVI, based on the data submitted from extensive clinical trials, is very clear: a single dose gives very high protection from the virus 10 days after the first dose. A second vaccine dose is important to sustain that protection and extend its duration. Of course, it makes sense to vaccinate as many people as possible as quickly as possible to protect their lives and safeguard the NHS, which is why we take the approach that we have.

[Baroness Deech (CB) [V]]

My Lords, today we are discussing the safety of medicines. Only moments ago, the Minister was emphasising just how important that is. Yet in delaying a second dose, the whole country is being treated as an experiment. Pfizer has said that the trial of the vaccine was on participants who received a second dose within three to four weeks. There is no data, it said, to demonstrate that protection after the first dose is sustained after 21 days. The WHO also says that there is no scientific evidence supporting the delay beyond six weeks. No other country is doing it. The UK is taking a gamble that risks fostering vaccine-resistant forms of the virus. Will the Minister mitigate the risks and ensure that a second dose is given at 21 days, until there is independent scientific advice and evidence for the delay?

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[Lord Bethell (Con)]

My Lords, I remind the noble Baroness that Pfizer is not a regulator, nor is the WHO. Other countries are working on vaccines, but they are behind the UK in terms of authorisation and rollout. I reassure her that there is data, which is published on the internet. I tweeted a copy of it late last night, and I invite her to have a good, close look at it because it is absolutely categoric: one dose is enough.

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

There is a heated debate going on in the United States, as reported on CNN, over the incidence in use and registration of both the first and necessary second vaccinations with particular concern over the second, without which the first is less effective, despite what the Minister has just said. What plans do the Government have in the United Kingdom to ensure compliance with the necessary take-up of the second vaccination and the registration of both by the authorities?

[Lord Bethell (Con)]

The noble Lord is entirely right: the second dose is important. However, it is important not for efficacy but for durability. We have put in substantial data provisions to record every single dose into every single arm, and to put a follow-up dose into exactly those arms. We are using the NIMS system and every single vaccination is put into the GP record. They will be tracked down extremely diligently for exactly the reasons that the noble Lord describes.

[Baroness Brinton (LD) [V]]

My Lords, a number of scientists have expressed concerns about delaying the second dose of the Pfizer/BioNTech Covid vaccine. On the excellent Radio 4 programme “How to Vaccinate the World”, Professor Sir David Spiegelhalter said that, as the RNA technology used is new, there is less data to give confidence on spacing. But he suggested that, given a number of people have received their first dose, now is the perfect time to do a small randomised research trial on comparing those receiving their second dose at 21 days and others receiving it at 12 weeks, which would then perhaps give more confidence. Is that happening?

[Lord Bethell (Con)]

Who can hold a torch to Professor Spiegelhalter and his analysis of the data? Although I did not hear him, I completely welcome his comments. I reassure the noble Baroness that enormous efforts are being put into the pharmacovigilance around this vaccine. Some of this is of a clinical and scientific nature, and it takes a while to read out. We have therefore put in parallel systems to get an early read-out on exactly the kinds of questions that she has asked.

[Viscount Eccles (Con)]

My Lords, as an interest, I can report that Lady Eccles and I have both had two Pfizer jabs, three weeks apart. At the planned rate of 2 million vaccinations a week, there will be the equivalent of 1 million people being fully vaccinated, whatever the gap. There will also be a continuing critical path through this rollout, which is complex. It may start by being vaccines, which are the limiting factor, but it could become otherwise. Can we be assured by my noble friend that the NHS is fully prepared to identify and deal with the critical path? Can we also be assured that we will get clear and full information on progress, and about the actions being taken to maintain that progress?

[Lord Bethell (Con)]

I congratulate my noble friend and Lady Eccles on their double vaccinations. It is one of the most heartening experiences of a pretty dreadful year to witness the rollout of this vaccination and the joy and reassurance it brings to those who have been vaccinated. I reassure my noble friend that the NHS is absolutely putting the resources in place not only to roll out the single and second vaccinations to everyone over 18 who will step up for those but also for the pharmacovigilance to ensure that any adverse effects are recorded through the Yellow Card scheme and that those records are analysed and acted upon so that any changes or tweaks, as sometimes happen, are enacted by the NHS to get the best possible outcome for as many people as possible.

[Baroness Hayman (CB) [V]]

My Lords, may I ask the Minister another question about evidence? When do the Government expect to have clear advice on the possible transmission risk from those who have been vaccinated? Everyone I know who has received the vaccine—they have been delighted to do so and impressed by the efficiency of the NHS—is now talking about meeting their Pfizered friends, seeing grandchildren and returning to volunteering or to your Lordships’ House. Does the Minister acknowledge that there will need to be cogent and clearly communicated advice for those who have been vaccinated, many of whom have been in virtual isolation for nearly a year?

[Lord Bethell (Con)]

The noble Baroness delivers tough news to her friends and to the Chamber, and I completely agree with her analysis. The frustrating truth is that, while the efficacy of the vaccine has been tested on hundreds of thousands in clinical trials, and we can lean on that data extremely well, the transmissibility of those who are immune is not yet clear. We have put in place trials and testing regimes to understand and get to the bottom of this point. But she is entirely right: it is possible, although not proven at the moment, that those who are themselves immune are not sterile but vectors of infection. Were they, for instance, to return to this Chamber, they would potentially infect those of us such as my noble friend Lord Parkinson, who is extremely young and does not qualify for the vaccine any time soon, and who could catch the virus off an octogenarian noble Lord in an instant.

[Baroness Thornton (Lab)]

The noble Baroness, Lady Hayman, raises the most important issue, which is communication and the way that the Government may allay anxiety. Something which has been put to me is that we know the risks to human health run by the creation of antibiotic resistance and the creation of mutant and resistant bacteria as a result of misuse, including inadequate doses. Can the noble Lord assure the House that immunologists are being consulted? What is their view of this risk? Anxieties are being expressed in many different ways, so there has to be better communication about this issue.

--- Later in debate ---

[Lord Bethell (Con)]

The noble Baroness is right that communication is key. We seek to explain the scientific basis of this vaccine, and a huge amount of effort has gone into what I call “O-level biology communications.” This is one of the reasons why acceptance rates appear to be—touch wood—as high as they are at nearly 90%. Had someone told me that number a few months ago, I would have happily settled for it. She is right, the escapology of this virus is just the same as it is under AMR. From very early analysis it would appear—and this is extremely conditional—that the recent variant is not escaping the vaccine or any of the therapeutics we have put in place. However, it is more performance enhancing. That is good news for the vaccine and bad news for the prospect of having a disease present in society and the world for some time to come.

[Lord Roberts of Llandudno (LD) [V]]

My Lords, this virus is unchartered hostile territory and we can but rely on the best scientific advice. Some will say that delaying the second jab might even be advantageous and others will disagree. By delaying, debating and disagreeing we are going to put many thousands of lives at risk, lives which could have been saved by having that first jab. I am not qualified to say which is the best; I wish I was. I can only in gratitude accept the guidance of experts and that is what I will do. In doing so, I think that hundreds or thousands of extra lives will be saved by that first jab.

[Lord Bethell (Con)]

The noble Lord alludes to a complicated dilemma that we all feel. I welcome challenge and those who query and question the basis of our policy decisions and our science. He is right: too much false information and fake news can damage trust. We have gone about the vaccine process with an approach that is as open and transparent as it can possibly be. We have sought to engage in dialogue and answer questions where there have been any. That approach has proved to be effective and it is the one we continue with.

[Baroness Browning (Con) [V]]

My husband, who is 84 years old, received his Pfizer vaccine before Christmas and his second one last week was cancelled. Is there any guarantee that, when the second jab comes, it will be the Pfizer vaccine? As I understand, there has been no research on mixing and matching these vaccines. Is there any way that the level of immunity can be tested at that three-month point?

[Lord Bethell (Con)]

The CMO has made it clear that he leans heavily towards having consistent vaccines, but it is not a requirement. Some of the immune response comes from antibodies which can be tested, but some of it is from T-cells, which are very difficult to test for. It is not possible to categorically say whether someone is immune. However, we have looked at ways to measure and understand more about the body’s immune response to develop our understanding in this area.

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

My Lords, what is the chance that, if the second Pfizer vaccine dose is delayed, the virus could become resistant to the vaccine? For what reason do Pfizer and the World Health Organization recommend three weeks between the vaccines?

[Lord Bethell (Con)]

The noble Baroness is right; this virus could mutate and start escaping the vaccine. That is a very real threat. The good news is that we know so much about it now, have digitally mapped it and have grown it so many times in the laboratory, that making new vaccines would be a relatively straight- forward process. It would not necessarily require the months of clinical trials that the first one did. However, be under no illusion, were this to happen it would set our vaccine deployment back considerably.

[Baroness Pidding (Con) [V]]

My Lords, I appreciate the necessity of getting as many people vaccinated as possible and the need therefore to be agile and flexible in making policy decisions. However, would the Minister agree with me and other Lords that it is also critical we win the battle of communications? We need to ensure that we take the public with us, with a clear understanding and a clarity of message.

[Lord Bethell (Con)]

The central proposition we are discussing is that it is better to double the number of people getting their first jab, even if there is a marginal decrease in the efficacy of the vaccine for a few people. That message has got through to the public and I think it enjoys tremendous public support. I acknowledge the concern that some will naturally feel about what appears to be a diminution in provision, but I am here to reassure and provide consistent scientific advice that is not the case.

[Lord Vaux of Harrowden (CB) [V]]

My Lords, two logistical questions are raised by delaying second doses. First, given AstraZeneca’s statement yesterday about variability of manufacture, together with the increasing global demand going forward, how will the Government guarantee we have enough vaccines of the right type for all second doses at 12 weeks? Secondly, am I right that from the end of March the rate of new vaccinations will fall sharply, because we will then need 2 million doses per week just to cover the second doses?

[Lord Bethell (Con)]

I think the noble Lord has read too much into the AstraZeneca statement. Negotiations with AstraZeneca and provisions in manufacturing capacity are extremely well advanced. All the projections in the vaccine plan published yesterday have been bottomed out and secured with manufacturers and deployment. The Secretary of State was very clear about the objectives of 13.6 million by the end of February and the whole country by the autumn. Those are not vague reassurances; those are bottomed out and have business plans behind them.

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

My Lords, the time allowed for this Private Notice Question has elapsed. I apologise to the noble Baronesses, Lady Uddin and Lady Gardner of Parkes, that there was not time to take their questions.

Cannabis Oil

Lord Bethell Excerpts

Tuesday 12th January 2021 Lords Chamber

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

My Lords, we are on the case. I completely recognise the problems faced by Alfie Dingley and all the individuals reliant on the previous arrangements with the Dutch Government for the supply of Bedrocan oils. The department is working urgently with Dutch Minister Tamara van Ark to find a solution that will enable these patients adequately to access the medications they need, and we are committed to setting up clinical trials to inform future NHS commissioning of cannabis-related medicines.

[Baroness Walmsley (LD) [V]]

My Lords, I thank the Minister for that very encouraging response. He will know that time is of the essence because these medicines prevent children having severe fits, some of which are life-threatening. Can he go back to his department and educate some of his officials? Unfortunately, a lot of the families are very upset at being told that they can safely be switched to an alternative formulation. That is both ignorant and dangerous. All the expert clinicians who know about these issues say that that cannot be done safely. Even if it could, eventually putting these children back on to the original formulation sometimes does not work. Will he make sure that his officials listen to the clinicians who are expert in prescribing and in following the progress of people on these formulations?

[Lord Bethell (Con)]

My Lords, I am grateful for the noble Baroness’s kind words, and I will indeed take that patient feedback back to the department. I reassure her that this is an area where patients have undoubtedly led the way, and clinicians have to catch up. In doing so, there will need to be a meeting of minds and regulation in areas that are open to patient interpretation. In that period, there will undoubtedly need to be compromises on all sides.

[Baroness Warwick of Undercliffe (Lab) [V]]

My Lords, the law changed over two years ago. The then Home Secretary said:

“We have now delivered on our promises … we will work with the NHS to help support specialists in making the right prescribing decisions.”


But they have not; it has been a hollow promise for terminal brain cancer sufferers such as my nephew. NHS doctors will not prescribe medical cannabis, and the BMA advises medics not to prescribe it, yet I understand that the UK is the largest producer of medical cannabis in the world. Just how many prescriptions have been issued for unlicensed cannabis medicines, other than those subject to randomised control trials, in the last 12 months?

[Lord Bethell (Con)]

My Lords, the noble Baroness is being a little unfair; Health Education England published a medicinal cannabis education package on 8 August 2019. But we cannot force clinicians to make prescriptions. That is not how the health service works. We need to work on clinical trials to put in place the correct authorisations and to give marketing authorisations for these important and promising drugs. That will require collaboration between government, the regulator and industry, and I call on industry to step up to that challenge.

[Baroness Barker (LD)]

My Lords, some people in England and Wales are reliant on hormone therapies produced in the EU 27. Who precisely in the NHS is responsible for ensuring continuity of supply of those therapies to patients?

[Lord Bethell (Con)]

My Lords, procurement decisions in the NHS are done by the NHS. I do not think that a specific or unique group is focused precisely on hormone therapies, but I would be glad to go back to the department and write to the noble Baroness to confirm that.

[Lord Mancroft (Con) [V]]

My Lords, I draw your Lordships’ attention to my interests as set out in the register. If we can vaccinate 1.5 million people in a few weeks with a drug that did not even exist a couple of months ago, how come we cannot prescribe properly a drug that has been legal to prescribe for over two years? Cannabis contains over 120 different cannabinoids and eight terpenes, and the way in which these are configured makes a world of difference to their effectiveness. What training is being given to ensure that the right combination of cannabis oil required to treat different medical conditions is correctly prescribed? I think it is time that the Government stepped up to the plate on the training.

[Lord Bethell (Con)]

My Lords, I would turn around my noble friend’s proposition and ask this question. If many vaccine manufacturers can turn around clinical trials in eight months for an extremely complicated vaccine, how come the cannabis-producing companies cannot turn around clinical trials over years?

[Lord Field of Birkenhead (CB)]

I thank the Minister for his reply. I declare that I am a cannabis user to counter pain, and no doubt later today we will be able to come back to that issue. I hope that his officials are watching to witness the support there is in this place for the role that he is trying to secure so that young sufferers who shake their brains to pieces might get relief today rather than tomorrow, when it is too late.

[Lord Bethell (Con)]

I thank the noble Lord for sharing that personal testimony, which is extremely touching and relevant. I share with him that there is a large amount of ministerial support for the principle of this exciting and interesting area. If there is any frustration on my behalf, it is only that somehow the industry has not matured to the point that it can sponsor the kinds of clinical trials that can take these important medicines through the necessary authorisation process that can put them on the NICE list so that they are available for more patients.

[Baroness Thornton (Lab)]

It is not surprising that people are astonished that important cannabis products, which can transform the lives of those suffering from debilitating, painful conditions, are approved yet still not available—and in some cases supply has been disrupted as a by-product of Brexit. Would the Minister care to speculate as to why this has not happened? It is not just that the companies have not stepped up—why have they not done so? Would the political will that has been brought to bear on various other issues faced by this Government, such as Brexit, not be usefully brought to bear on this one?

[Lord Bethell (Con)]

The noble Baroness puts a very reasonable challenge to the life sciences arrangements in the UK. We are blessed with major pharmaceutical companies, and a lively and exciting biotech industry, all of which are well plugged into the regulatory authorisation process. This is a novel, exciting, patient-led and innovative area. For those reasons, it has not had the financial backing of either business or the financial institutions to put in place the very simple, straightforward requirements of clinical trials, which are there for patient safety in the first place, not for government box-ticking. We are working extremely hard to try to resolve this Catch-22 situation and I hope very much indeed that we will be able to announce news on that shortly.

[Lord Addington (LD)]

My Lords, it is nice to hear that the Government are taking this problem seriously. If these drugs are effective, would it not be a good idea to encourage the demand side of this equation, where doctors prescribe them, by pointing out what the drugs allow a child with epilepsy, for example, to do—that is, lead a normal life, get educated, get qualified and be able to have a job—and the cost to the state if they do not?

[Lord Bethell (Con)]

The noble Lord alludes to an important, although frustrating, point. If I may gently push back, the truth is that there is a large amount of very persuasive anecdotal evidence, some of which we have heard today. It is completely compelling—it is just not scientific. Patient safety relies on extremely rigorous clinical trial regimes; that is why we have safe medicines in the UK. It is simply not possible to persuade front-line clinicians to make prescriptions on the basis of anecdote rather than clinical study.

[Baroness Stuart of Edgbaston (Non-Afl) [V]]

My Lords, I am delighted that the Minister is on the case and that we can make sure that this issue is resolved for this set of parents. On a wider note, however, would the Minister consider revisiting the NICE guidelines, last published in November 2019, which had a list of recommended research, to ensure that we potentially widen the base of research and bring more speed into the process?

[Lord Bethell (Con)]

The noble Baroness is right that research is the key. I reassure her that we are looking at ways to try to bring research forward. The issue is not with the NICE guidelines themselves; it is with getting the scientifically backed data to be able to justify the authorisations from the MHRA. We are working extremely closely with the NIHR. We are looking at the NHS, which, as the noble Baroness likely knows, does have manufacturing capability within itself for these kinds of drugs. As some noble Lords here will know, we are engaged in thoughts about how the NHS manufacturing capability can be used to mobilise clinical trials in this important area.

[The Deputy Speaker (The Earl of Kinnoull) (Non-Afl)]

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

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

Lord Bethell Excerpts

Thursday 7th January 2021 Lords Chamber

Moved by

[Lord Bethell]

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

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

Motion agreed.

Covid-19: Restrictions

Lord Bethell Excerpts

Thursday 7th January 2021 Lords Chamber

[Lord Robathan]

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

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

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

[Lord Robathan (Con)]

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

[Lord Bethell (Con)]

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

[Baroness Mallalieu (Lab) [V]]

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

[Lord Bethell (Con)]

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

[Baroness Walmsley (LD) [V]]

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

[Lord Bethell (Con)]

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

[Lord Herbert of South Downs (Con)]

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

[Lord Bethell (Con)]

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

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

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

--- Later in debate ---

[Lord Bethell (Con)]

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

[Baroness Thornton (Lab)]

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

[Lord Bethell (Con)]

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

[Lord Lilley (Con)]

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

[Lord Bethell (Con)]

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

[Baroness Falkner of Margravine (CB)]

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

[Lord Bethell (Con)]

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

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

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

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

Lord Bethell Excerpts

Thursday 7th January 2021 Lords Chamber

Moved by

[Lord Bethell]

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

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

Motion agreed.

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

Lord Bethell Excerpts

Thursday 7th January 2021 Lords Chamber

Moved by

[Lord Bethell]

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

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

Motion agreed.

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

Lord Bethell Excerpts

Thursday 7th January 2021 Lords Chamber

Moved by

[Lord Bethell]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

--- Later in debate ---

[Lord Bethell (Con)]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Motion agreed.