Covid-19 Vaccine Rollout

Baroness Jolly Excerpts

Wednesday 9th December 2020 Lords Chamber

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

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

[Baroness Jolly (LD) [V]]

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

[Lord Bethell (Con)]

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

Coronavirus Vaccine

Baroness Jolly Excerpts

Thursday 3rd December 2020 Lords Chamber

[Baroness Wheeler (Lab)]

My Lords, I thank the Minister for the Statement. Yesterday’s great news about the Pfizer/BioNTech vaccine and the MHRA’s clinical authorisation was the breakthrough that we all hoped for. We on these Benches join in with the heartfelt thanks to the dedicated scientists and those who have taken part in the trials, testing and validation process. Coming with the absolute assurance from the MHRA that no corners have been cut by it in the speeding-up of the vaccine, and that safety of the public has rightly remained paramount, the news is especially welcome.

Hospital trust staff will receive the vaccine first. This is a massive logistical challenge given the size of the workforce, the temperatures that this vaccine must be stored at and the two doses needed. We understand that 50 hospitals are already set up and waiting to receive the vaccine. How many NHS staff are expected to be vaccinated by January? When will mass-vaccination centres start opening in our communities?

On care homes, today we have the reality of the difficulty of ensuring that the vaccine can be delivered safely and quickly to them, in the light of its low temperature requirements and because of the fragmented social care system, involving thousands of predominantly small providers employing permanent and often frequently changing temporary staff. The Joint Committee on Vaccination and Immunisation’s Covid-19 priority lists advises that care homes residents and the staff who treat them should be first in line to be inoculated. We now understand that only care home staff will be among the first to be vaccinated, travelling to an NHS centre. While this and readiness in parts of the NHS to administer the vaccine are welcome, can the Minister update the House on how the Government will ensure that in the rollout of this essential vaccine, that hopefully will help to protect thousands of care home residents, they do not find themselves at the back of the queue once again? Care home managers are demanding clarity over this issue and have warned of confusion and raised expectations among vulnerable people.

Overall, we have historic strengths with vaccination, but in recent years we have lost our measles-free status, and we know that vaccination rates can often be lower in poorer and more vulnerable communities. While Covid-19 has affected everyone, the burden of the pandemic has disproportionately impacted the poorest, who are more likely to die than the richest. Can the Minister ensure that there is a health equality strategy, so that black and ethnic-minority groups, and the poorest and most vulnerable, do not miss out on this vaccine?

I also make a special plea for unpaid carers. Carers UK is deeply disappointed that carers are not on the priority list for the vaccine in England. Can the Minister explain the thinking behind this by the JCVI or the Government? They were prioritised for the flu vaccine, as it was recognised that if they get flu, the loved ones they care for are at risk and cannot be properly cared for. As a carer myself, I am in touch with many local carers, who play a vital role in keeping older, disabled and seriously ill people safe during the pandemic.

On the supply of vaccines, the UK has promised 40 million doses by spring, which is estimated as enough to give the required two jabs to health and care workers and everyone over 65. Nevertheless, in the first few weeks of winter, our ability to vaccinate could easily outstrip supply. Current figures are that there will be 800,000 doses in the country within days, with several million more to follow in weeks. I understand that the jabs are being manufactured in Belgium. What assessment have the Government made of the impact of Brexit on importation? Can the Minister reassure the House that supplies will not be disrupted, deal or no deal? We all understand that the restrictions will remain in place for some time but in the meantime, if someone is vaccinated, will they still have to isolate if contacted by test and trace, or are they now released from that obligation?

The Government’s document, Community Testing: A Guide for Local Delivery, suggests that local areas can use mass testing as a freedom pass. What does this mean in practice? How will local areas enforce rules if some people are able to follow different rules based on their testing status? In the Commons yesterday, the Prime Minister suggested that people may want to take advantage of mass testing ahead of visiting their families this Christmas, but what does this mean for people in areas that do not have access to lateral flow testing? Needless to say, despite the approval of a vaccine the restrictions will need to remain in place for some time, and test and trace will be key. Can the Minister confirm that mass testing will therefore be rolled out in all areas in time for Christmas? What are the consequences of the Christmas exemption period if not?

We must not forget that the Minister’s Statement also announced the welcome news that family visits can now take place in care homes, subject to visitors testing negative for Covid-19. However, the increase in staff and resident testing, alongside the introduction of visitor testing, must be backed up by additional resources to make this possible. What extra funding is being made available to care homes to meet the costs of additional testing, cleaning, PPE and visitor administrations that they will incur?

Today’s focus is on the vaccine and how it will be distributed. However, for the record, in response to the Secretary of State, Matt Hancock, claiming that the process of vaccine approval has been one of the early benefits of leaving the EU, the MHRA has today made it clear that the process for developing and authorising the vaccine has been undertaken under the terms of European law, which remain in force until the completion of the Brexit transition period at the end of the year. In other words, Matt Hancock’s assertion is simply not true.

[Baroness Jolly (LD) [V]]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

HIV: Pre-exposure Prophylaxis

Baroness Jolly Excerpts

Tuesday 1st December 2020 Lords Chamber

[Lord Bethell (Con)]

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

[Baroness Jolly (LD)[V]]

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

[Lord Bethell (Con)]

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

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

Baroness Jolly Excerpts

Tuesday 1st December 2020 Lords Chamber

[Baroness Jolly (LD) [V]]

My Lords, this has been an excellent debate. I found myself agreeing with many noble Lords on several issues. These regulations take us out of the national lockdown and into a revised tiered system. In theory, this is something that I agree with: a targeted approach which infringes on the freedoms of only those for whom it is necessary. I have some sympathy with my noble friend Lord Greaves in his admiration for the contribution of the noble Lord, Lord Dobbs, but I do not support the amendment of the noble Lord, Lord Robathan. At times, I agreed with his assessment of the Government’s handling of this: communication was poor and the level of dither was astounding.

I also welcome many of the revisions to the previous tiers, which impose tighter restrictions on aspects of social life while extending support bubbles for some households at highest risk of isolation. However, there are some serious issues that need to be considered.

My noble friend Lady Brinton mentioned people with a learning disability. At the beginning of the virus, there was a scandal about GPs putting “DNR” on to the records of people with learning disabilities without any consultation with family or care homes. Fortunately, the CQC intervened and made it clear without any equivocation that this was not ethical, acceptable or legal.

Many concerns have been raised about the criteria for tier allocation. Of course we need a system that takes a more nuanced approach than just the number of cases in the population but, when restrictions are so damaging to the local economy and residents’ mental well-being, we need transparent data and decision-making. Last week, the transparency data was published a day late and we still do not have the full scientific evidence behind the rationale for different tier restrictions. Many noble Lords have given the impact assessment the ridicule it deserves. It is crucial that the Government engage with local authorities that know what is happening on the ground to inform decision-making. How do the Government plan to engage with local authorities to ensure they can make informed decisions that go beyond just raw data? Can we also get reassurance that political pressure is not the hidden sixth criteria for tier allocation?

There have been concerns about the size of the geographical areas that are grouped for tier allocation. Areas with low infection rates are understandably frustrated, as they are grouped with nearby areas with higher rates. Countries with robust test-and-trace systems are able to target their restrictions with far more precision; that is what this Government should be aiming for. Can the Minister please tell the House what progress was made on improving test and trace during the national lockdown? Are the Government now beginning to recognise the amazing efforts of local test-and-trace teams who use their existing expertise? How much of the £7 billion in additional funding will go to local authorities to help them trace the most difficult cases? We all know that the first 80% or so are straightforward to trace, but it is the last 20% who are the problem. Local public health teams, who know the area, can find those out-of-the-way addresses.

Now I would like to consider the rule of six. Under national lockdown rules, children under five were exempt from the rules on one-to-one meetings. Will the Government now make children exempt from the rule of six? This issue is particularly pertinent for parents of young babies who were born in lockdown and have not had access to the usual support systems. Under the rule of six, new parents can meet only in groups of three, despite these informal support networks being so important to maternal mental health. I hope that the Minister will consider this and provide a response which will make England consistent with Scotland and many of our European neighbours.

The new regulations make the new tiered system more restrictive than that which came before. Combined with some specific easing over the festive period and adjustments to policies on support bubbles, this has the potential to be confusing, to say the least. There has to be a clear communications strategy that aims to reach particularly hard-to-reach communities. As these restrictions are being brought into law with significant fines attached, the onus is on the Government to ensure that individuals know exactly what they can and cannot do—and that if they do what they want, it should be clear how much it will cost them. This is rarely mentioned at Downing Street briefings; nor does it make the front page of the dailies or the evening news.

My noble friend Lord Scriven gave us a blow-by-blow breakdown of all the recent SIs laid in your Lordships’ House for us to debate. The seeming randomness of the measures in each subsequent SI was appalling.

Christmas is an emotive issue. Many of us miss our loved ones greatly and the opportunity to meet in person at Christmas is ever so tempting. Although in-person celebrations are allowed, this should not be confused with them being encouraged. I am pleased that we have managed to obtain national consensus on Christmas bubbles. I hope that, in the new year, we will see much more of this co-ordinated approach. How are the Government going to ensure that the message is clear? Remote ways of meeting are the safest and are recommended to connect with the family.

I know that in my household, we will have a virtual Christmas this year to protect each other and show solidarity with those whose religious celebrations could not go ahead in 2020—those who did not celebrate either Diwali or Eid ul Fitr. There will be a time when it will not pose a danger to see the ones we love, but now is not it. Taking this virus seriously means recognising those who will remain isolated this Christmas: care home residents are just one example.

The winter plan outlines a significant increase in the testing occurring in care homes, with specific mention of visitor testing and testing of staff. I welcome this, but I would press the Minister on how the Government anticipate that Christmas will operate in care homes. This morning, I received an email from the chief executive of Care England, a representative body for independent care homes, who said:

“The issue about visiting in and out of care homes goes far beyond Christmas, we want to craft robust guidance that deals with the short, medium and long term. The guidance needs to recognise the intricate balance between well being and safeguarding. Although the new testing regime is extremely welcome we need to face facts that it will be a while until it is entrenched and also needs to operate as part of a raft of other infection control measures.”


No additional resources have been announced to assist with this testing. The National Care Forum estimates that an average 50-bed care home will need to administer at least an additional 1,350 tests per month, amounting to an additional 450 hours of work or an extra 15 employees. This time is taken away from caring for residents, with no replacement. Care homes need additional resources and support to have the capacity to implement the testing that we have so long called for.

The restrictions we have all been living with have had a significant impact on our economy, mental health and well-being. Every person in the country has made a huge personal sacrifice and we cannot fall at the final hurdle. We now know that there is a get-out-of-jail-free card and, within a few months, many of us will be vaccinated with one of the growing number of vaccines. I would like the Minister to put to the department that the most vulnerable adults of working age are those with a learning disability. However, they were not even on the first list that I saw for early vaccination. For nearly a year, we have suffered lockdowns and other restrictions. Living in a tier 1 area, I will resist the Boxing Day trip to Staffordshire to see my family. We will leave it to spring and rely on a video Christmas. But this means getting restrictions right and keeping them so, then regaining the public’s trust so that they can confidently follow the guidance, knowing that they are doing the right thing to protect their family, friends and neighbours.

Covid-19 Update

Baroness Jolly Excerpts

Monday 30th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

I thank the Minister for taking this Statement, and I look forward to discussing the regulations that will flow from it tomorrow, if they successfully pass through the Commons. Although we can see that cases are going down—and that, of course, is a matter for celebration and relief—we are still seriously in the pandemic. We still seriously stuck in what seems like an endless cycle of lockdowns, which have not been working.

The Government have again wasted the opportunity, over the past few months, to get a handle on testing, tracing, isolating and supporting. Once again the hospitality industry in many parts of the country will be absolutely battered. Once again jobs will be in further jeopardy. Once again our theatres are closed. Once again older people, disabled people and people with learning difficulties remain stranded in care homes without visits from their families. Exactly what will be the difference this time that will make people’s sacrifices yield a reduction in the infection rates? When shall we see testing in care homes, for example?

Reflecting on the debate in the Commons following the Prime Minister’s and the Secretary of State’s announcements last week, we see that all MPs of all parties were desperate for two things. They were desperate to understand the basis on which these decisions were being taken, and they were desperate to understand how their constituents might be able to move from, for example, tier 3 to tier 2, or tier 2 to tier 1.

As my honourable friend Rachel Hopkins MP says:

“The good people of Luton will want to get out of tier 2 as soon as possible, but the current resources provided to Luton Borough Council for the lateral flow rapid testing pilot are insufficient to enable it to provide the level of mass testing that is being described nationally. The contained funding—£8 per person—just will not cover tests for 10% of Luton’s population, as the funding also needs to be used for the wider covid response, including wellbeing support for vulnerable residents.”


She asked the Secretary of State, and I now ask the Minister here, to

“confirm that there are national plans to provide additional support and resources to expand testing if the intention to test close contacts daily is pursued”.—[Official Report, Commons, 26/11/20; col. 1012]

The news about the vaccine is the light at the end of the tunnel, but noble Lords must be well aware that we are still well into the tunnel, and probably will be for months to come. The only sure way to contain the virus is for people to obey personal rules and, most crucially, for us to have an effective and locally controlled test, trace, isolate and support system. We on these Benches have known this and have been asking, if not begging, for the last part of this deal for many months. Despite the Minister’s constant issuing of large numbers one way or the other, it is still not working as it should be. It is not surprising that confidence in the Government’s ability to deal with the pandemic is at a low ebb, much lower than in March and April.

Yesterday I heard the Conservative Rother Valley MP Mr Stafford say on television that he thought we were in trouble with this virus because people had broken the rules—in other words, let us blame the public. He was taken to task firmly by my honourable friend Naz Shah MP, but I have to ask the Minister whether he agrees with his colleague Mr Stafford.

When areas such as Bury and Trafford went into lockdowns in the summer, the Secretary of State promised that MPs would be involved in the decision. Has that commitment now been abandoned? Then Ministers agreed to involve regional leaders but, it has to be said, took exception to being challenged by Andy Burnham. What role do regional leaders now have in these decisions, or is the position really that the Prime Minister imposes from Downing Street restrictions on communities across the Midlands and north that will have huge impacts on the livelihoods of families and small businesses? What are the plans to alleviate the hardship that these rules will create? Leicester, Bury, Leigh and Heywood have been under a form of lockdown for months, with families forced to part and grandparents not seeing their grandchildren. Those families will want to know today what the exit strategy is and what voice they have in that strategy.

The Secretary of State in this Statement has outlined five criteria by which local lockdowns will be judged. Will that be published, with clear, transparent rules for areas entering and leaving tiers and a scorecard for every area, assessing its Covid progress against its criteria so that everyone can judge this in a transparent fashion?

What have the SAGE advisers said to the Minister about the risks which go with the proposed lifting of restrictions for Christmas? The Canadians have a very clear message about this. They say, “Stay home and stay safe”, and the reason they say that is because the worst surge in Covid-19 they have ever experienced followed six weeks after their Canadian Thanksgiving. They have given warning to their southern neighbours—the United States—that they will see an even bigger and more devastating spike following their annual gathering for turkey and gratitude at Thanksgiving. This is a warning that we need to heed. Does the Minister agree?

[Baroness Jolly (LD) [V]]

I thank the Minister who is going to respond to this Statement.

The first case of this coronavirus was just over a year ago, on 17 November 2019. Since then, over 1.3 million people have died worldwide and over 50 million people have been infected. The first case here in the UK was on 29 January this year. We watched Italy deal with the cases in late winter, and I am sure that plans were being fetched out of the archives on how we might deal with a pandemic. I know that in 2015 there was a pandemic plan published for an influenza outbreak. Will the Minister tell the House what lessons were learned from that exercise?

I remember walking back to my flat in London on 17 March and my son, who was living with me then, said, “You either go home today, or you stay until this clears”. I went home, and on 23 March lockdown started. Along with many other noble Lords, I stayed away for some considerable time, and Zoom, Teams and virtual working became the new normal.

Hong Kong, which is always waiting for a SARS outbreak, keeps a stock of PPE for all care homes in the event of a pandemic. Is it too early to ask the Minister whether that is something he would now consider for England? I think it was a recommendation of that pandemic preparedness document in 2015.

One area where I would also be grateful for clarification is that of test, track and isolate. At what stage was it decided not to involve the local experts and local authorities? This caused much regional frustration, as this was the biggest public health crisis for many years, and local public health leaders were being sidelined. They know their regions well, and in areas where they did work, it worked well. Let me be clear that in a Lib Dem world, local authorities would test then track those with a positive result and support them practically and emotionally in their isolation.

As the noble Baroness, Lady Thornton, has articulated, many of the public have said that they did not fully understand restrictions. When putting messages together, who did the Government picture they were talking to? From whom did they get their advice? Who did they test their messaging on? This is a case where conversations with the Plain English Campaign, or perhaps the Canadians, would have been helpful.

The last time tiered restrictions were in place, less than half of people in the UCL Covid-19 Social Study said that they fully understood the rules. With changes to the tier system and a five-day relaxation, will the Secretary of State make changes to the Government’s communications strategy to aid compliance?

Some of the Covid economic measures have helped people in the short term, such as the furlough scheme, which our colleagues in the other place fought so hard to get. However, the Government excluded more than 1 million people from Covid support and froze pay for local authority staff, who have also played a vital role in combating this pernicious disease. It is an assault on local authority workers and services.

Nurses too have been hoping for a pay rise. The Chancellor stated:

“Our health emergency is not yet over and our economic emergency has only just begun”.


He explained that the

“immediate priority is to protect people’s lives and livelihoods”,

and that the spending review is set to deliver stronger public services. He continued:

“taking account of the pay review bodies’ advice, we will provide a pay rise to over a million nurses, doctors and others working in the NHS.”

He promised

“the 2.1 million public sector workers who earn below the median wage of £24,000”

that they

“will be guaranteed a pay rise of at least £250.”—[Official Report, Commons, 25/11/20; cols. 827-28.]

That should include porters, auxiliaries, and other key, low-paid hospital workers.

Countless families are facing serious financial hardship. More than 1 million people have lost their jobs, and the devastating impact of this pandemic will continue to be felt acutely throughout the next year. We are also facing big challenges in deep-seated inequality. We must ensure that no one is left behind. The Government win plaudits for the furlough scheme, but they have failed to provide a serious economic strategy for dealing with unemployment, climate change and inequality. I fear the Government’s Brexit plans will make job losses and business closures much worse. No deal or a bad deal would be a huge blow for businesses and jobs just when we need to be recovering from this crisis.

Although the winter plan broadly outlines the five criteria used for determining the tier system, would the Minister be more transparent about what the exact entry and exit points of the tiers will be? I understand it is not always possible to give exact criteria, but even a rough idea would help the public know what they are aiming for when the Government are asking them to make so many sacrifices.

This has been relentless since the middle of May. At a briefing meeting today, we heard that the acute care sector was at full pelt, and this is before winter sets in. The Minister is rightly proud of the Nightingale units. Do we have staffing for them? Should we need them? Many clinical staff are totally exhausted. Many question whether they want to carry on in the profession. Are the Government making sure that a safety-critical profession can reach safe staffing levels by filling tens of thousands of unfilled nursing jobs?

Children are the most vulnerable to the social impacts of local restrictions and have had formative years of their lives severely affected. With the rule of six being reinstated after national lockdown, will the Minister commit to an exemption from the rule of six for children under 12? It really does make sense.

What is the Minister’s current estimation of the likely length of the restrictions? Being open and transparent on likely timings and not creating false hope are critical to maintaining public support for any public health measures. After all, the PM said earlier this year that we would be back to normal by Christmas, and how wrong he turned out to be.

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

My Lords, I thank the noble Baronesses for their thoughtful and searching questions on an important day’s traffic of announcements from the Government. I would like to try to tackle them as comprehensively as I can, but I assure both noble Baronesses that I will write to them on any points I fail to address in these comments.

The noble Baroness, Lady Thornton, started by saying that she felt the endless cycle of lockdowns had not been working. It is undoubtedly true that we all regret the return to a national lockdown earlier this month, but it is not true they do not work. New infections are down by a third, and that is an enormous achievement by the British public, whose discipline and obedience to the restrictions has yielded a massive dividend.

The noble Baroness said that test and trace was not working. It is undoubtedly true that when prevalence levels are so high, when there are more than half a million infections in the country and when new infections are running at five digits, it is extremely challenging for any national testing and tracing system to keep up with that sort of capacity. I beg the noble Baroness to give some ground and acknowledge the achievement of the huge scaling of the number of tests, the vast number of people who have been asked to isolate, thereby breaking the chain of transmission, and the hard work of those who work on the tracing side of the business, which has dramatically increased its performance and will continue to meet target numbers.

The noble Baroness also talked about care homes being stranded. I remind her that we have come a huge distance. I could reel off a dozen achievements in the care homes strategy, but two stand out. First is the regular testing of staff, which has now become a systematic programme that has massively protected those in care homes. There has also been the recent introduction of testing for visitors, which brings welcome relief for those needing to support and visit those in care homes, a much-valued service that needed a huge amount of work to put into place.

The noble Baroness talked about the role of the public. I have alluded to my respect for and thanks to the public. I will be crystal clear: the challenge that we face as a country is not public apathy but the virus itself. There is an absolutely vicious aspect of the virus, which is its high contagiousness. In a room with a few people together, it is quite unlike most contagious diseases in its infectiousness. When we talk about the challenge of social distancing and the need for lockdowns, it is not one another whom we blame: it is the virus itself. I encourage all those who feel frustrated to remember who the enemy is.

The noble Baroness asked whether the tiering allocations would be done in consultation with local authorities. The brief answer to that question is no. We tried that, but it did not prove a successful experiment. The acrimony and large amount of delays created long-standing problems for the implementation of the policy. Therefore, we will be implementing the tiering on a fortnightly basis from the centre. It is a big yes, however, on the approach to community testing and infection control. We absolutely want to work in partnership with local authorities and local DPHs, which have all the powers that they need to decide whom they seek to target and what incentives they would like to provide for those who need to be attracted to testing. I also say yes—absolutely—to transparency, both in terms of the publication of the numbers and our approach to our collaborations. I put on record our massive thanks to local authorities, particularly those that have been working with us over the last fortnight on our community testing programme, the publication of which earlier today is a really important framework of the local-national partnership of which I have spoken at this Dispatch Box many times. It really brings alive that commitment.

The noble Baroness, Lady Jolly, was entirely right that there was an influenza plan, but it envisaged a completely different type of virus. The lessons from the influenza plan, though relevant for the kind of flu envisaged, were not applicable for the coronavirus. A good example of that is the PPE. Had we followed the possibility of preparing a massive stock of PPE for the kind of flu envisaged in the influenza plan, we would have had the wrong kind of PPE. There was nothing that we could have done about that.

The other big learning was on mortality rates. The mortality rates for Covid-19 and the long-standing effects that it has on people are completely unlike those of the kind of flu that we were envisaging earlier. It has been a grave learning curve to have to change our plans to deal with Covid.



In relation to other learnings or things that we have moved on since then, I reiterate a theme that I have mentioned before: our commitment to national and local test and trace. Quite understandably, the noble Baroness challenges me on that point, but I gently remind her that, in February, local authorities did not have any tests; nobody had any tests. We were doing 2,000 tests a day. Therefore, it is all very well saying that we should have left test and trace to local authorities, but there simply were not the resources there to do that. It took a massive national programme and huge national effort to get us up to half a million tests a day, which is something that the local authorities, even in collaboration, could not possibly have done.

The local authorities also did not have scalable tracing capacity. The PHE capacity was designed for ultra-low prevalence rates—for when you are chasing a few dozen carriers of a disease who, perhaps, have recently arrived from overseas. It was not designed for 20,000 infections a day, which is the kind of infection rate we have been looking at recently. It was only by building the data systems, protocols and guidelines, and having tens of thousands of employees, that we have been able to put that tracing capacity in place.

We also did not have the organisational or analytical capacity to do the kind of surveillance that is done through ONS and REACT or the kind of data management that the JBC has done. Now that we have those components in place—the physical, data and diagnostic frameworks—we are in a position to work as a team, both nationally and locally. The noble Baroness is entirely right that that local insight, intelligence, empathy and leadership are absolutely critical for our success, and I encourage her and all those in the Chamber to read our community testing programme, which was published earlier today and which encapsulates the spirit of the local-national partnership of which the noble Baroness has spoken previously in the Chamber.

The noble Baroness challenges me on communications, and I will not deny that it has been one of the great challenges of the pandemic to try to explain, in a fast-changing and confusing climate, the government imperative and recommendations to the public. One of the key things that we have learned is that, sometimes, the desire to share the delicious complexity of the epidemiology stands in the way of simple communication. Sometimes, trying to find the exemptions that are fair to everyone and cater to every single consultative recommendation stands in the way of simplicity, straightforwardness and tractability.

We have learned that, sometimes, it is more important to be simple, clear and straightforward than to try to accommodate every nuance and exception. This is why we have pursued rules like the rule of six, have gone for a simple and easily understood regional tiering process and applied the 10 pm curfew, although we have updated that to an 11 pm curfew, with a drinking-up time of 10 pm. That kind of consistent messaging is what the public, quite reasonably, respond to, which is why we have moved to it.

In response to the noble Baroness’s question about under-12s, I say that there are both the communication and epidemiological reasons that children are vectors of disease. This is an uncomfortable truth because they very infrequently show any symptoms and it is incredibly inconvenient—I say this as someone with four children, three of whom are under 12. However, it would be epidemiologically irresponsible to try to make an exception in that way, and I certainly will be spending quite a lot of Christmas with my family.

In relation to hardship, the noble Baroness makes the point extremely well, and we are totally sympathetic to her point. It is undoubtedly true that the least advantaged will be the hardest hit by this epidemic. It is true because their jobs are hit hardest, particularly those in casual labour, because the virus often hits those who have the most cramped accommodation or low-quality health and because many of those who live on the borderline of life will be the ones nudged into poverty.

The Government have worked hard, with the furlough scheme in particular, to ensure that a financial safety net is put into place, but I have no doubt that there will be a moment when the economic hardship created by the pandemic will be acute, and I have no doubt that the mental health implications of that for the population will be extremely hard. The Government are extremely aware of that and we are trying our hardest to minimise the impact. One reason why we are hitting the virus hard with these tiers is to ensure that we can get the economy back as quickly as we can, mostly to the advantage of those who are hit the hardest.

The noble Baroness asked me about entry and exit points to the tiers, and I have no easy solution for her. There are very clear considerations which we will be looking at when we consider which regions go into which tier: case detection rates, particularly of those over 60; the rate at which cases are falling; the positivity rate; and pressure on the NHS. But this is an incredibly complex matrix of interdependencies. It is not simple to plop it into the kind of easy algorithm that can churn out an answer at the push of a button; nor is it easy to have one simple metric where we can say, “You’ve hit this and therefore you move this way,” or “You’ve failed and you move that way.” If it were so easy we would publish it. The best advice we can get is that we have to consider all those factors when making those decisions. We will do it in a spirit of transparency, but we will have to make tough decisions. I reassure noble Lords that it will happen every two weeks, as the Prime Minister explained, and we will seek to be as fair and thorough as we possibly can.

Brain Tumour Research

Baroness Jolly Excerpts

Thursday 19th November 2020 Lords Chamber

[Lord Bethell (Con)]

I hear the noble Lord’s words loud and clear. I reassure him that the good news is that Tessa Jowell left behind her in the Tessa Jowell Brain Cancer Mission an incredibly effective organisation that is holding the feet of Ministers firmly to the fire —not least through my noble friend Lord O’Shaughnessy, who is on my case in a very big way.

I recognise that this is one of the tricky scientific challenges of our age. We have struggled to tackle adult brain tumours for a very long time. There has to be investment in the basic science around them, in the techniques, such as the very focused radiology, and in provable therapeutics that work in the field. This is not going to happen overnight, but I reassure the noble Lord that we are committed to finding a solution.

[Baroness Jolly (LD) [V]]

My Lords, the noble Lord, Lord Reid, referred to Baroness Jowell’s final speech, when she told us not to give up fighting this pernicious cancer. The noble Lord, Lord O’Shaughnessy, the then Minister, gave the assurance that the Government would not cease support for research into new treatments. Can the Minister confirm how many more research programmes into brain tumour treatments and therapies have been funded by NIHR since then? Is he confident that enough is being done?

[Lord Bethell (Con)]

My Lords, I have a table of all the brain tumour research projects that we have backed over the last 10 years and I would be very glad to share it with the noble Baroness in correspondence. The short answer is, not enough. I would like there to be more grants and of higher value, but I recognise the challenge. When I speak to the scientists—even Richard Gilbertson, who is a very measured practitioner in this area—they recognise that more work needs to be done at an earlier stage to ensure that they are the kinds of projects that the NIHR system can back. We need to have a conversation about how we can encourage the early-stage science and the creative drafting of fresh ideas for that pipeline. That is something that I am very keen to get on with and have a dialogue about.

Covid-19: Conflicts of Interest

Baroness Jolly Excerpts

Wednesday 18th November 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I am grateful to the noble Lord for referring to my calls. I would have made a lot more than 300 calls then, because those were extremely difficult times. I would remind him that the NAO report says that we found Ministers had properly declared their interests, and we found no evidence of their involvement in procurement decisions or contract management. Ministers were not involved in procurement decisions; they facilitated the introduction of potential suppliers at a time when there was a massive global crisis. Supplies to this country were being abducted by other countries, supply chains had broken down, the channel tunnel was constrained and the Indian transport system had ground to a halt. Presidents were literally diverting planes in the air with supplies meant for one country and grabbing them for their own. In those circumstances, Ministers and their advisers intervened to get the right supplies to the front line to help those seeking PPE. Those were extremely energetic efforts. I am extremely proud of that work. Procurement decisions were left to civil servants.

[Baroness Jolly (LD) [V]]

My Lords, Ministers have many opportunities to meet a wide range of individuals and organisations in the course of their work, and they have to declare their interests. Is it the department’s HR department or its Ministers who are responsible for ensuring that spads understand both their role and their boundaries, and that they stay within them?

[Lord Bethell (Con)]

My Lords, there is a very clear code for special advisers. They have line management through the Secretary of State and often on to Downing Street. The role of spads during the pandemic has been exceptional. I pay tribute to the large number of spads who made a huge difference, and I am very proud of the work that they have done.

Department of Health and Social Care: Unpaid Advisers

Baroness Jolly Excerpts

Tuesday 17th November 2020 Lords Chamber

[Lord Bethell (Con)]

I am grateful to the noble Lord for highlighting three calls to suppliers. I should like to reassure him that those were absolutely exceptional times, when our supply chains had broken down and we were competing with other Governments for extremely scarce resources. I personally did not make three supplier calls; rather, I made 300. I put out literally hundreds of calls on behalf of the Government to try to find the medicines, supplies, diagnostics, PPE and all manner of medical requirements needed for this country. I could have done that only with the help of the networks, energy, skills and support of those who stepped forward to help us at our time of need. I repeat, I am extremely grateful for that support. It does not warrant a place on the front page of the Sunday Times but the lack of follow-up from that newspaper article speaks for itself.

[Baroness Jolly (LD) [V]]

My Lords, we all wish to live in a time of transparent government. On 6 April, I understand that a Minister in the department had a phone call with a former Conservative Party chairman and an adviser who had not been publicly declared, as well with as a businessman who had donated a significant five-figure sum to the party and who was later awarded PPE contracts of more than £150 million. Does the Minister know if the contract was open to tender? Given the donation and the nature of future PPE contracts, why was that not considered to be an inappropriate call?

[Lord Bethell (Con)]

I take this opportunity to thank the very large number of Members of this House who contacted me during that period. My inbox was filled with thousands of emails every day, including emails from Lib Dem, Labour, Cross-Bench and Tory Peers, all of them seeking to help us during our time of need. I sought to reply to as many as I could, but I fear that I did not reply to enough and I did not mean any discourtesy. I spoke to a large number of those people, as my transparency register makes very clear. The telephone call on 6 April to which the noble Baroness has referred was not in any way inappropriate. I am extremely grateful to all those who stepped forward to help us when we needed it.

Medicines and Medical Devices Bill

Baroness Jolly Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

I endorse the recommendations from the noble Baroness, Lady Cumberlege, in her report First Do No Harm. It is important that MHRA works closely with NICE, but I hope that it will also work with patients. Patients should be trusted: it is their life, and their hope for the future. The overriding need for better patient safety is, I hope, what this Bill will advance.

[Baroness Jolly (LD) [V]]

My Lords, I particularly welcomed the remarks of my noble friend Lady Burt, as they took me back to the days in the 1990s when I taught IT. I taught A-level students the differences between databases, tables and registers. I totally support these amendments about registries and databases relating to medical devices. They form one of the key recommendations of the review of the noble Baroness, Lady Cumberlege, in light of the scandals relating to, for example, vaginal mesh.

A huge number of patients have been affected by these incidents, and introducing registries allowing the use of implantable devices to be tracked, and allowing patients to view information relating to the data stored, would make a huge difference. Amendment 95, from the noble Baroness, Lady Finlay, changing “may” to “must”, is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill setting up the new information system envisaged by Clause 16.

Amendment 96, in the name of the noble Baroness, Lady Thornton, is a probing amendment seeking clarity about whether the Government intend to track all medical devices used in the UK, rather than a selection. Amendment 99, in the name of the noble Baroness, Lady Finlay, seeks to make mandatory the list of specified issues for regulations to cover. Her Amendment 100, to which I have added my name, would allow for the creation of a system of information regarding implants, with appropriate consents and oversights. It would also allow a patient’s experiences to be reported and stored; they should be subject to oversight. The noble Baroness, Lady Finlay, has also included the point about patient experience in her Amendment 101.

Amendment 104, in the name of the noble Lord, Lord Lansley, would require regulations under this section to have regard to the Caldicott principles. It was just over 20 years ago, when I was a non-exec director in a local NHS trust, that these principles were first introduced. I can remember the way that clinicians—in particular, senior clinicians—really welcomed the new measures. They certainly changed the way that clinicians thought about information and data. We are now moving through a different step change.

Finally, my noble friend’s Amendment 107 would require the introduction of a registry for patients who have had surgical mesh implanted. Though I appreciate that this looks retrospective, there should be data held in hospital databases that could be imported into the new registry. It would then give a complete overview of surgical mesh implantations. It would require the Secretary of State to report on progress towards creating databases relating to other devices or implants and how they would lead to the creation of registries.

Like other noble Lords, we favour registries as opposed to databases because, according to the Cumberlege review, registries act as a repository for more complex patient-related information datasets, enabling research and investigation into patient outcomes. A database is really just a three-dimensional table held in store, but a registry is a richer, more useful resource than a database. However, often a database is required before a registry can be created, which is why our amendment is framed in that particular way.

[Baroness Thornton (Lab)]

My Lords, this group concerns the need to set up information systems—registries—which will serve the purpose of tracking medical devices. I thank the Minister and the Bill team for their very enlightening and useful presentation this morning. The noble Baroness, Lady Finlay, and other noble Lords have already explained to the Committee how these registries and databases might work. The key point, which was made by the noble Baroness, is that they should be mandatory rather than permitted. Changing “may” to “must” so that the Secretary of State has to produce the information system envisaged by Clause 16 is a small but vital change. The Minister will need to explain to the Committee why, at this stage and after the experiences expressed and covered in the report of the noble Baroness, Lady Cumberlege, there should be any discretion in this matter.

The other amendments seek to ensure that patients have a direct route to report their experience to any information system established. Again, after the dismissal of so much patient experience over so many years in the cases outlined in First Do No Harm, it would seem to be the only way to guarantee that patient experience can be heard and registered.

Amendment 96 in my name is a probing amendment which seeks clarity about whether the Government intend to track all medical devices used in the UK, or just some of them. As other noble Lords have pointed out in the course of this Committee, if supermarkets have the technology and wherewithal to track the provenance of every single food product from anywhere in the world, we would need to understand why this would not be possible for medical devices.

Amendment 107 specifically addresses the issue of surgical meshes, and requires the production of a registry for patient safety. I hope that the Committee will be seeking to discuss registries and how they are linked. On Amendment 104 on the Caldicott principles, I do not see how anybody could possibly object to that.

--- Later in debate ---

With those few words, I support the sentiments behind Amendments 105 and 127, but I am concerned that there should be proper consultation over a 12-week period, and that the results of and responses to the consultation will be published for us all to read.

[Baroness Jolly (LD) [V]]

My Lords, these amendments relate to consultation. My noble friend Lord Sharkey’s Amendment 129, to which I have added my name, specifies some people or classes of people who should be involved but who have in the past been omitted—patients or representatives of patient groups, medical research bodies, the pharmaceutical industry and academic researchers.

My noble friend asked a good question of the Minister about why the consultation in Northern Ireland is with the department and not the Minister. The Select Committee on which I sit has engaged with the Northern Ireland Government in various areas of policy. They often do things well, but they do it their way.

The amendment also calls for details about consultation timings, consultees and proposed publication details. The point the noble and learned Lord, Lord Mackay of Clashfern, made about contacting patients was a really good one. His remarks follow on from those of the noble Lord, Lord Hunt of Kings Heath. Many consultations involve patients, but they are often with what I might call professional patients. This is not a derogatory statement, but sometimes they are the usual suspects and the story does not change. That can lead to a loss of a total patient view.

Government Amendment 126

“requires a relevant authority to carry out a public consultation before making regulations under any provision of Part 1, 2 or 3, and to set out the authority’s assessment of any matter to which the authority must have regard in making the regulations”.

It also requires the Secretary of State

“to consult the devolved administrations in relation to regulations under clause 16 (1).”

In this morning’s useful meeting—I join others in thanking the Minister for hosting such a fascinating session—we touched briefly on Scotland, Wales and Northern Ireland. Would the Minister confirm that the devolved nations are being consulted on their involvement in their use of our registries, and maybe ours of theirs?

Amendments 125, 127 to 130 and 132 all relate to consultation when making regulations, including, but not limited to, the devolved Administrations, patient groups, various healthcare organisations and academics. Consultation is key to all this, with clinicians, who will give you one set of information, but even more so with patients, who will give you a different, richer, more detailed dataset.

[Lord Bethell (Con)]

My Lords, Amendment 105, tabled by the noble Baroness, Lady Thornton, would mandate consultation with the devolved Administrations before making regulations under Clause 16. This question has been raised by a very large number of those who have contributed. Amendment 132, also tabled by the noble Baroness, would insert after Clause 41 a separate obligation to consult on regulations made under the Bill that relate to matters within devolved competence.

Both amendments are unnecessary. It goes without saying that we will consult the relevant Northern Ireland departments where it may be possible to make regulations jointly under Parts 1 and 2 of the Bill for the benefit of the whole of the UK. I reassure the noble Baronesses, Lady Jolly and Lady Masham, and all others who mentioned consultation with the devolved assemblies that we are in very regular contact. There are fortnightly four-nations calls. These include NHS Digital where necessary. We intend to maintain this level of engagement. It has proved constructive and has contributed enormously to our plans for broad consultation on the mechanics of the Bill.

While medical device regulation relates to reserved matters, the provision of healthcare services, including the healthcare data collected, is devolved. As the regulations about the establishment and operation of the information systems encompass both areas of responsibility, it is right and proper that the Secretary of State is required to consult the devolved Administrations before making regulations under Clause 16(1).

The noble Baroness’s amendment appears on the list before my own, but Amendment 126 in my name, which I will come to shortly, is appropriate for this situation. It makes it very clear that the devolved Administrations will be consulted on regulations to be made under Clause 16. This reflects that provisions in those regulations may relate to devolved as well as reserved matters.

Amendment 127 in the name of the noble Lord, Lord Patel, is unnecessary. My Amendment 126, which I will come on to shortly, would apply a statutory duty to carry out a public consultation precisely because we know how important it is for patients and other stakeholders to be involved. The intent of Amendment 127 is already achieved by Clause 41 and is further clarified by the government amendment.

Amendments 128 and 129, tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Sharkey, would commit the appropriate authority to consult all those listed before making regulations under the Bill. We all wish to ensure that a range of views are adequately captured. However, we do not wish to inadvertently rule out contributions from those accidentally not listed. Those listed in the amendments would not necessarily be directly affected by each regulation. For example, regulations relating to human medicines prescribing would not affect veterinary medicines. I reassure the noble Lord and the noble Baroness that the consultations will have depth and reach, and that medical research charities will be fully involved. Requiring consultation with all those listed would be unduly burdensome and seemingly add little value to the making of regulations.

On Amendment 130 in the name of the noble Baroness, Lady Thornton, I completely understand that there are perhaps some concerns with the extent of consultation, or, indeed, its duration, or that the Government might seek to consult on proposed regulations without sufficient notice to those wishing to comment. This is simply not the case, but limiting us in this way may hinder the delivery of important regulations coming into force. If the Bill were to be significantly delayed, it would mean that we could not make an efficient start on consulting stakeholders on key policy areas, such as on a future regulatory system for medical devices.

Whether consultation is conducted prior to the Bill achieving Royal Assent or afterwards, we will make it clear to stakeholders when the consultation processes will start and end. Consultations will be targeted, form part of a process of engagement and last for a proportionate amount of time. For my part, I cannot wait for the process to begin. It is very exciting.

I know that noble Lords want to know our plans for consultation, as do I, and when precisely that will begin. I reassure my noble friend Lady McIntosh that we will publish responses to consultation. We will follow the Cabinet Office guidance, which is extremely stringent. I am incredibly enthusiastic to reach that next step and to begin to make changes to the regulatory regime to deliver a comprehensive, stand-alone and first-class medical devices system, as well as to consult and have the benefit of informed views, like those of the noble Lords, Lord Kakkar and Lord Patel, among others, when we discussed provisional rapid licensing.

I want to make changes to the clinical trials regulations and to consult on how we can make improvements and update definitions. Also, of course, I want to bring in the medical devices information system regulations so that we can establish a world-leading medical devices safety regime. I indicated the intention to consult in the first quarter of 2021 on the innovative medicines fund. We intend to start public consultation on the medical devices information system in May 2021. We also hope to take forward the medical devices regulations consultation over the summer of 2021. There is obviously sequencing to do on all the other measures that we will want to bring in. I will update the House on our consultation plans in due course. The dates are dependent on getting the Bill done, of course.

As to Amendment 126 in my name, I heard the noble Lord, Lord Blencathra, ask at Second Reading how Parliament could be consulted on regulatory changes. Others reflected on the importance of consulting patients on the regulatory changes that impacted or mattered to them. I know that there has been concern about whether the relationship to the pharmaceutical and medical device industries is such that they might be unduly weighted in consultation, but I assure noble Lords that that is not the case.

To provide reassurance, Amendment 126 changes the obligation in Clause 41 to public consultation. The effect of the amendment would not be to prevent the appropriate authority from inviting responses from certain stakeholders or groups as the authority might consider appropriate. Engagement and close working will continue, but Amendment 126 will ensure greater transparency and enable even more people to become involved in the consultation.

The duty to consult the devolved nations on Clause 16 has been the subject of ongoing conversations and correspondence between Ministers in the devolved nations and me. I spoke earlier about the nature of these regulations relating to both reserved and devolved matters. Specific considerations will need to be taken into account in relation to how the devolved healthcare systems function and we want to ensure that any information system that we create is as effective as it can be. The information system will provide an important tool for improving the safety of medical devices for patients throughout the four nations of the United Kingdom. It has always been our intention to consult fully the devolved Administrations on the development of the regulations. I am making this change to provide greater reassurance and confidence, both to the devolved nations and to Peers who have raised the significance of ensuring interoperability between any such information system and devolved healthcare systems.

The final change made to Clause 41 by Amendment 126 will mean that participants engaging with the consultation can understand how the considerations have been taken into account so far. This additional transparency will, I hope, provide noble Lords with assurances that we have taken the criticisms on board and have provided a method for Parliament, the public and stakeholders to know how our thinking progresses throughout the development of regulations made under the Bill.

The combination of these changes strengthens the consultation requirement in the Bill. I hope that, taken together with amendments that I have made elsewhere in the Bill, it goes some way to meeting your Lordships’ concerns and that the noble Baroness will feel able to withdraw her amendment. I commend my Amendment 126.

--- Later in debate ---

[The Deputy Chairman of Committees (Baroness Fookes) (Con)]

I next call the noble Baroness, Lady Jolly, and I dare say that there will be a little pause before she speaks.

[Baroness Jolly (LD) [V]]

I support Amendment 108, led by the noble Lord, Lord Patel, which would place a duty on the Secretary of State to disclose information they hold

“relating to a medical device where there is a clear threat to public safety.”

Amendment 114, also in the name of the noble Lord, Lord Patel, would retain Regulation 3B of the Medical Devices Regulations 2002, which was inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and, among other things, requires the 2002 regulations to comply with the Data Protection Act 2018.

I support these amendments but wonder what might be the process to contact patients in the event of a fitted medical device fault, which might lead to a threat to public safety if it was more than just one. Would it be the same sort of process as that for recalling certain faulty domestic appliances, which, by law, also need to be recorded? Noble Lords may chuckle, but there is a system there. Where the patient has a medical device implanted, who is responsible for taking patient contact information?

More importantly, how does the patient ensure that their contact data is up to date? Will it link, using the unique patient reference number: their 10-digit NHS number? It would need the patient to ensure that their personal data is kept up to date via the website or app. Many do use the NHS app, but, given the patient demographic, I would not be that confident in relying on that mechanism. I am not sure that the general public are ready for that requirement or, in many cases, have the capacity or devices to fulfil it. Could the Minister clarify this for me?

[Baroness Thornton (Lab)]

I am very grateful to the noble Lord, Lord Patel, and the noble and learned Lord, Lord Mackay of Clashfern, for bringing these amendments to the Committee. They are quite different, although linked. On Amendment 108, which would place a duty on the Secretary of State to

“disclose information … about concerns relating to a medical device where there is a clear threat to public safety”,

the noble Lord, Lord O’Shaughnessy, absolutely got it when he said that this is not a “may” but really is a “must”. The thing about this that would interest me most, because it is an important duty, is how it could happen: what would trigger such a disclosure, where would it come from and how would it be handled?

The only thing I would ask about this issue is whether a Secretary of State is the right person to do that. I have in mind someone who is now a respected noble Lord of this House, who fed his daughter a burger to show us that beef was safe during the BSE outbreak, which led to the creation of the Food Standards Agency as an independent organisation that would say, “This food is actually unsafe”, to the Government. It quite rightly has the powers to bring about a closure or recall. This is exactly the right place to be on patient safety. The only question I would pose is: is that the right person to do it?

Amendment 114, on Regulation 3B, worries me enormously. I would need to have an explanation from the Minister as to why he would remove confidentiality and seemingly protect commercial interests. It is very worrying, and the Committee needs to know the justification for that because it looks to me like it probably needs to remain in place.

--- Later in debate ---

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

My Lords, I can only begin this contribution, as I did at Second Reading, by paying tribute to the power and importance of the report by the noble Baroness, Lady Cumberlege, as so many other noble Lords have. I also note that the length of the list of Peers speaking to this amendment reflects the fact that this is perhaps the most important element of her recommendations, or certainly the most easily and directly deliverable through legislation.

When thinking about how I could contribute within this long list of speakers in a positive way, I decided to go back to the noble Baroness’s report and to the patients who spoke to her. If I were delivering this as a public speech, I would at this point deliver a trigger warning: what I am about to say is very disturbing. That needs to be said now.

I will quote three of the patients quoted in the noble Baroness’s report. The first is identified as a mesh-affected patient who said:

“I have had a constant battle to get the help and treatment I needed with my mesh complications. ‘Gaslighting’ and a ‘fobbing off’ culture appears to be rife”.


The second quote is from a former GP and mesh-affected patient:

“I do … believe there is a huge unconscious negative bias among you all towards middle aged females in chronic pain.”


Finally, the third quote is from Teresa Hughes, from Meshies United:

“They would tell you there is nothing wrong with you and that you are just a hysterical woman”.


It is worth reflecting briefly on the history of medicine and the medical profession. The idea of a wandering womb—with strange afflictions supposedly affecting women, particularly those of reproductive age—goes back to the ancient Greeks. We have something here that has been embedded for literally millennia. If we look to more recent history, it was the book on hysteria by Edward Jorden in 1603 that really pinned down in English something that became medical doctrine for centuries. This treatment of female patients has a very long and embedded history.

If we look back at the 1960s and 1970s, up until that point in time the culture of medicine was very much one of paternalism. The doctor, who was most often a male, knew best; the patient was told what they should do and how they should be treated. The doctor knew what was best for them and the patient had very little say or control. We can credit the women’s movement as an important part of the forces driving for change in the medical profession. We have seen change, but medical habitus does not change quickly in its practices and culture. It is clear from those quotes I just read out that there is still a long way to go. There is a strong gender aspect to this, but many male and child patients were affected by it as well.

A patient safety commissioner could be someone to go to: someone who knows the system and has sufficient technical support to understand the issues, and to see where systematic breakdowns are happening and act on them. The Children’s Commissioner is a wonderful example—the noble Baroness, Lady Cumberlege, referred to it—and by chance I was referring to that commissioner approvingly in this very same Room yesterday.

We have already seen action on the recommendation for a patient safety commissioner in Scotland, and I am proud that the England and Wales sister party, the Scottish Greens, was very strong in supporting that. With this amendment, your Lordship’s House has a real chance, as we have been doing with so many Bills lately, to insert an important and key improvement.

I hope that, if not today then sometime very soon, the Government might see the sense of following the Scottish lead and the recommendations of the report of the noble Baroness, Lady Cumberlege. However, if that is not the case, I can certainly offer the Green group’s very strong support for pushing this further—as far as it needs to be pushed—to deliver this vital figure.

[Baroness Jolly (LD) [V]]

My Lords, Amendment 117 would establish the independent patient safety commissioner on a statutory basis, as recommended in First Do No Harm, the report of the Independent Medicines and Medical Devices Safety Review. As the noble Baroness, Lady Cumberlege, said, it is a future-facing amendment towards a proposed organisation. It has not been a surprise that all noble Lords who have spoken have been hugely supportive of her report. This recommendation from the Cumberlege review was overwhelmingly supported by the House at Second Reading and is vital to ensure that the interests of patients are represented, to try to prevent scandals such as that regarding mesh implants from recurring. We support it wholeheartedly, and I was delighted to add my name to the amendment.

At present, there is no one to listen to the voice of patients, act on concerns, gather data and put together a clear picture to report back to the department. Commissioners can bring a fresh pair of eyes to an area but also a strong voice for patients. Of course, as the noble and learned Lord, Lord Mackay of Clashfern, said, they bring independence too. In addition, they will have unique statutory powers and responsibilities, such as powers to get access to data, and investigatory powers, with power of entry if necessary. Of course, patients’ voices would need to be heard, so in all probability, there would be a helpline, as well as email access and access via a website and by letter.

The noble Baroness, Lady Cumberlege, spoke of the Children’s Commissioner, and she was not alone. It has been a great success. The commissioner knows her remit and, as the noble Lord, Lord Hunt of Kings Heath, said, she speaks with no vested interest except in children, and she stays within it. She champions children and, as has already been said, this has given her authority. As a consequence, the organisation is hugely respected.

I have heard the criticism of the cost of such a body as the patient safety commission, and I feel sure that the noble Baroness would have squared off the funding for a commissioner and their office with the Cabinet Office, which would be the funding vehicle. However, compared with similar commissions, it would amount to less than £1 per head of population per year—less than tuppence per person per week. I defy anyone to claim that that is excessive. This is indeed of value, and patients of course deserve it.

[Baroness Thornton (Lab)]

The last remark of the noble Baroness, Lady Jolly, was very pertinent indeed.

After this debate, I probably need to say only that, from these Benches, we support the noble Baroness, Lady Cumberlege, in her proposal to establish a patient safety commissioner on a statutory basis. We have heard powerful contributions from the noble Baroness, Lady Cumberlege, herself, the noble Lord, Lord Patel, and my noble friend Lord Hunt. I always thought, when I was a Minister and since, that you should always listen when the noble and learned Lord, Lord Mackay of Clashfern, says that, in his “respectful submission”, something is a good idea; it is always a good idea for the Minister to take note of that.

European Qualifications (Health and Social Care Professions) (EFTA States) (Amendment etc.) (EU Exit) Regulations 2020

Baroness Jolly Excerpts

Monday 16th November 2020 Lords Chamber

[Baroness Jolly (LD) [V]]

My Lords, there is much to be welcomed in these regulations. It is essential that there are minimal disruptions in the NHS and social care workforce at the end of the transition period. The coronavirus pandemic has shown us that these workers are the most essential among us, and any measure that encourages workers to come to the NHS and our social care services is needed.

I am pleased the Government are going beyond the 2019 SIs to ensure that Swiss and other EEA workers have longer periods to apply for recognition and can continue to provide services. However, some detail is still in the dark. First, it is unclear what reciprocity there will be for UK nationals wanting to work in EEA countries. Will UK qualifications be recognised in EEA countries following the transition period?   

Secondly, these are temporary measures, but individuals who wish to come and work in the UK need certainty for the long term. The health and social care sector needs sustainable and reliable immigration to fill posts with high-quality professionals. Can we get any indication today of what the long-term plan is for immigration from these countries?  

There is a staffing crisis in our NHS and in social care. We are all well versed in the figures: 122,000 vacant posts in English trusts alone and a pledge of more than 50,000 nurses from this Government. Workforce issues that already existed have been exacerbated by the referendum result and the pandemic, meaning that wards are often understaffed as staff isolate. With the Government’s immigration Act receiving Royal Assent last week, I must use this debate as an opportunity to ask the Minister what steps the Government are taking beyond this legislation to encourage immigration within the health and social care sector. 

As this legislation relates to Swiss nationals, it is worth remembering that in September, Swiss voters decisively rejected an accord that would end free movement. This is something our neighbours in Europe value, and we need to be shown to be making immigration as fluid and free of barriers as possible. That is not the current impression.   

Finally, I would like to make a remark about parliamentary scrutiny. In 2019, we saw a huge number of SIs come through this House preparing for the worst-case scenario—leaving the EU with no deal. Debating the 2019 SIs was seen as almost pointless, since crashing out of the EU seemed so unlikely and, as the Prime Minister said, would be a case of failed statesmanship. However, we are now in mid-November and no deal is appearing more and more likely, with little news from Brussels or this Government about the progress of negotiations. Has adequate thought been given to what was initially seen as contingency planning? And was there enough parliamentary scrutiny of the 2019 SIs? I sincerely hope so.