(6 months, 1 week ago)
Lords ChamberMy Lords, it is a great honour to speak after the noble Lord, Lord Foster, who put the case for this group of amendments incredibly well. I do not want to go over the ground he has already covered, but I would just like to endorse three key points behind them.
First, children should be afforded the same protections against inappropriate content, whatever channel they are on. As my noble friend the Minister will remember well, what goes on in the real world should apply also to the digital world and vice versa. Secondly, it is the role of Parliament—no one else—to set out the rules when it comes to issues as important as the safety of children. Thirdly, companies that wilfully and knowingly fail to take steps to protect children should face the consequences. Those are the three principles behind this group of amendments and I thank the noble Lord for putting them so well.
I also thank some of the companies and stakeholders with whom I have engaged in the drafting of these amendments. As noble Lords may have noticed, the amendments have changed quite a lot between Second Reading and our meeting today. The reason is that companies have made good points and we have adjusted the amendments to reflect some of those: I thank in particular Disney and Sky for the engaging, positive and constructive way in which they have conducted these conversations.
Amendment 60 is incredibly straightforward. It is to include the British Board of Film Classification as a statutory consultee when Ofcom is drafting new video on demand codes. Statutory consultees are very common. The Children’s Commission was added during the Online Safety Bill and the BBFC is highly respected. So I hope very much that that could be waved through by my noble friend the Minister.
Amendment 61 is really the main focus of my remarks today. It would bring in a minimum standard across all ratings across tier 1 services. It would allow providers to either use the BBFC’s world-class and highly robust system or—and this is a very important “or”—a system of their own that meets equivalent standards. That is the gap that this amendment seeks to fill.
Following discussions with the providers, it also includes a provision for services provided by linear broadcasters to use a system based on the Ofcom Broadcasting Code. If I can, I will briefly explain that point. Many broadcasters have a linear service that is quite reasonably overseen by Ofcom and have a Broadcasting Code arrangement. It seems sensible—to me at least—that those standards should apply to their VOD broadcasts as well. That was one of the changes we were pleased to make to the amendments we have laid.
Amendment 61 sets out the process by which Ofcom can assess the ratings systems that are not based on the BBFC’s and, following the discussions I mentioned, the ability for Ofcom to designate some content, such as news or live events, as exempt from age ratings. That seems like a sensible exemption to me. Amendments 62 to 66 are consequential on Amendment 61 and would extend Ofcom’s enforcement powers to cover breaches related to the minimum standards for age-ratings requirements.
During Second Reading, there were some concerns raised that it would be inappropriate to mandate a particular solution and that these amendments might go against the tech-neutral approach of the overall Bill. If that were the case then I would share those concerns, but I reassure noble Lords, who will see this from the text, that those concerns are based on a misunderstanding of both the intent and substance of these amendments. The provisions would apply only to tier 1 services that choose to use age ratings as part of their overall audience protection duties. No service would be forced to use age ratings against its will and the requirements would not apply to any service that finds a different or better audience protection measure, whether that is tomorrow or in 50 years’ time. Nor would it mandate a specific age-ratings system, such as the BBFC’s. In fact, my amendment provides a clear choice of three different approaches, one including a bespoke service to them, provided it meets the minimum standards.
That is what my amendments are really about. They aim to ensure that, in the same way parents know what PG and 12A mean when they go to the cinema or buy a DVD, they can trust the age ratings that pop up on their TV at home or on the basis of their parental controls. For that reason, I hope very much indeed that my noble friend the Minister will embrace this set of amendments.
My Lords, Amendments 67 and 69 are in my name on the Marshalled List. Amendment 67 would add signposting measures to the audience protection measures which Ofcom must review under new Section 368OB of the Communications Act 2003. Amendment 69, in common with the amendments that have already been spoken to, would require Ofcom to consider whether age-rating systems used by a tier 1 service meet a set of minimum standards.
My amendments are very similar to those tabled by the noble Lord, Lord Storey, and the noble Baroness, Lady Benjamin. The key to our amendments and those of the noble Lord, Lord Bethell, is the need for us to be consistent in the way that we deal with children and age rating, so that systems are easily understood by parents and fulfil the standards that we have in this country about child protection, wherever it is. The Minister will be aware of all this, since he lived through the Bill that is now on the statute book as the Online Safety Act.
I was slightly surprised when I received a briefing which was signed by many of the stakeholders in this area—a number of companies, but it also included the PSBs. It made an argument against the three sets of amendments that have been put down. I was rather struck by this—I think they were a bit naughty in this briefing, in my view. For example, they included the public service broadcasters, which are not affected by this; this is absolutely not relevant to them. I would like the Minister to confirm that that is absolutely the case: this is not about their content at all.
The briefing also makes various statements about the commitment that many of the companies have to collaborating with Ofcom during the passage of the Bill, but that they want to take into consideration “audience research Ofcom conducts”. If it is the case that these companies are all committed to this then I can think of no reason why they would object to the minimum standards that we have put in our amendments being in the Bill. We are not saying that they should necessarily adopt the BBFC standards; what we are saying is that they need to show that their age ratings are comprehensive, understandable and sensible.
Some of these big beasts, if I might call them that, which have objected to this are doing it because they are big beasts. Frankly, I am unimpressed by that. We know, for example, that the same thing happened when New Zealand was dealing with this issue. But guess what? They are all complying with minimum standards there and it does not seem to have been a problem. If they can do it in New Zealand, I cannot see any reason why we would not be able to do it in this country.
(2 years, 10 months ago)
Lords ChamberMy Lords, I an enormously grateful for this debate, because this clause and related clauses are critical both to achieving the digital transformation aims of the NHS, referred to by the noble Lord, Lord Clement-Jones, and to getting the healthcare system to work better together.
I am also grateful for the humanity and testimony of several noble Lords, exemplified by the noble Baroness, Lady Finlay, who spoke movingly about the practicalities of patients going to see their doctors. I know from my own life and from my family how important it is to protect those relationships.
That is why I would like to hear a little from the Minister about what protections there are, because health data is and should be treated as a special category of data. What additional protections are there in the use of health data, including in the common law duty of confidentiality, the role of the National Data Guardian, the way the Caldicott principles will be used and the national data opt-out? What reassurances do we have that those special considerations will apply to this clause and its related components?
My Lords, I agree with my noble friend Lord Hunt and those speakers who expressed their concern about the open-endedness of what is in the Bill at the moment and the lack of protection for patient data. I look forward to the Minister’s reply on this.
(3 years, 2 months ago)
Lords ChamberMy Lords, it is a question of balance. We certainly have to be extremely careful about people visiting those with Covid because of the obvious contagiousness of that disease. As I said, the guidance is currently to limit the size of groups to one close family member, but we are mindful of the mental health impact of that, so trusts are trying to get the right balance between contagion control and the mental health implications of people being ill and alone in hospital.
It is very nice to see the Minister in his place; I wish him good luck right now. May I say how much we welcome the measures relating to visits in care home premises from 16 August? Welcoming anyone into care homes poses risks and it is important that those risks are managed and mitigated. In the face of the winter plans that have been announced, is there any expectation that there will be a review of these guidelines for care homes under plan A or plan B?
My Lords, I am pleased to say that 91% of care homes in England have been able to accommodate residents receiving visitors, compared to 40% in March. That is huge progress and answers a very large amount of concern that I have heard here in the Chamber. It is our objective not to change or review these measures. We want to try to keep care homes open to visiting in a safe way, as we do presently. If it becomes necessary, though, we will take the steps to protect life.
(3 years, 2 months ago)
Lords ChamberMy Lords, we are very grateful to the Commonwealth Fund, based in America, for its very important report and its updated rankings. I note that the criteria in the report have changed considerably over the years. On the report’s key points, I agree that there is more that we can do on patient equity. The Government have put health inequality at the centre of their agenda, and we are working hard on implementation. On care process—the other key finding of the report—we do not recognise the report’s analysis.
Well, how convenient. The UK’s drop in rank in the Commonwealth Fund’s five-yearly research into the performance of the world’s wealthiest 11 countries’ healthcare systems from first to fourth still seems to be associated, as the noble Lord has said, with access to care and with equity. This is important because the key differences between the top-performing countries, of which we are still—just—one, and the worst performing healthcare systems, of which the USA is, by a long way, the outlier, concern universal coverage, removal of cost barriers, investment in primary care systems, reducing bureaucratic burdens and investment in social services, particularly for children and working-age adults. Can the Minister explain to the House how the announcement on social care last week and the current NHS reform Bill before Parliament will contribute to the UK’s healthcare performance and ranking in the next five years?
My Lords, the noble Baroness half answers her own question. When it comes to universal coverage, I am extremely proud of the NHS and the service that we provide to the British public. There is no other health system like it anywhere in the world. The report makes cogent points on equality, and we have put that at the centre of our agenda, and in the NHS long-term plan, the prevention Green Paper and the newly implemented Office for Health Improvement and Disparities. We are doing that work through the obesity plan, the NHS health checks, the tobacco control plan and the vaccination plan. We are highly committed to this agenda, and we are making an impact.
(3 years, 2 months ago)
Lords ChamberAs my noble friend knows extremely well because of her close connections with the industry, GPs and pharmacies are responsible for purchasing their own flu vaccines through the seasonal flu vaccination programme, directly from manufacturers or wholesalers. Deliveries are phased and typically take place over a long period from September to November. As I said earlier, the disruption we have had in the supply was from one supplier for one or two weeks. It has not had a meaningful impact on the supply of flu vaccines to this country.
The Minister and the Government need to catch up with what is going on on the ground. I think almost everyone in your Lordships’ House knows someone who has had their flu vaccine appointment cancelled. There are two such noble Lords over there. I know three people in the House whose flu vaccinations have been cancelled. Perhaps he needs to go back to have another look at this.
The BMA has called for a COBRA meeting on the shortages of test tubes and transport. The Minister might think it is scaremongering, but it actually has a right to be alarmed. First, in these circumstances, if there are further delays and shortages, will he and the Government have a system of prioritisation? Secondly, how will the NHS encourage better take-up of flu vaccination among NHS staff?
My Lords, I hear loud and clearly the very obvious feedback from noble Lords about cancelled appointments. It is not the same as the guidance that I have been given, but I will look into it when I get back to the department and will be happy to write to the noble Baroness with an update on them. With regard to test tubes, I reassure her that guidance was issued to the NHS and GPs recommending actions for medical directors, nursing directors, GPs and pathology laboratories. It required refinements that had an impact, but those with an acute need for blood were accommodated and a COBRA meeting was not needed.
(3 years, 2 months ago)
Grand CommitteeMy Lords, I thank the Minister for introducing this late regulation. As I said to him last week, there is a sort of “Groundhog Day” tendency in having to deal with these things. I would also like to register with the noble Baroness, Lady Barker, that the House needs to address the issue of the noble Baroness, Lady Brinton, being able to access these sessions in the same way that she can access the Chamber. I would even go so far as to say that it is discriminatory that she cannot. As well as that, we are missing her wisdom, words and her representation of her points of view.
The noble Baroness, Lady Barker, and my noble friend Lord Hunt have covered many of the points and have asked many of the questions that need to be asked on this regulation. As noble Lords have said, it triggers the end of most of the lockdown restrictions in England by revoking regulations and amending regulations listed in the schedule from 19 July. I echo what other noble Lords have said. Does the Minister believe that it was premature to remove face mask regulations? I have not yet read the 30-odd page toolkit document in full, so I do not know whether the option is there to reintroduce them as part of the autumn-winter Covid plans. Would that be mandatory?
At the time of lifting the restrictions, from these Benches we opposed and still oppose the decision to remove the requirement to wear a face covering indoors and on public transport. The risk of transmission inside a crowded bus or train will be high. If it is true, as the scientists say, that one in 70 of us in England has Covid, and the capacity of a double decker bus is about 70 and a full Tube train or regular train carriage can carry up to 140 passengers, that would mean that on average one person on a crowded bus and two people on a crowded Tube train will be contagious. They will have Covid, and with little ventilation and no legal requirement to wear a mask.
I travel on public transport all the time—it is how I get to your Lordships’ House and go home—and it is certainly noticeable that mask-wearing, particularly among young men, has fallen. It is true that on the Tube there are marginally more people wearing masks than on the Overground, but the number has fallen. It is very concerning and worrying, and I have got to the point where I have stopped being a mask monitor and offering people masks if they have not got one on, because there are too many of them on the Tube and on trains without masks on.
We supported the removal of restrictions on gatherings, but we thought the Government were going too far and too fast at the time. We were also concerned that the lifting of all the restrictions was confusing to businesses. Has the Minister had feedback about how effective the lifting of those restrictions was? This instrument extended the expiry date of the Health Protection (Coronavirus, Restrictions) (England) (No. 3) Regulations to the end of September to ensure that local authorities retain the power to respond to local serious and imminent public health threats as a result of the spread of coronavirus. Can the Minister confirm whether the Government intend to further extend these provisions? If it is in the winter plan I apologise, but I think we will be discussing that tomorrow or Thursday.
I suspect that the winter plan contains which bits of the Coronavirus Act are being retained and which will be got rid of. However, what worries me is whether in three or four weeks’ time, if infection rates have increased enormously as a result of the schools going back, there will be sufficient powers to deal with that, and sufficient powers if we need to go into further restrictions. The Minister must explain what will happen if the worst happens. The byword throughout the whole pandemic has been “Let’s plan for the worst and hope that we don’t have to use those powers.” If all those powers are being rescinded now, what will we do if there is a new variant further into the winter or we see a spike in the next three or four weeks? We need to know that.
In terms of mask wearing, I went on holiday to Scotland by train and it is true that as we neared the border, there was an announcement that everybody had to wear a mask, and everybody put a mask on. It was not an issue. Like the noble Baroness, Lady McIntosh, I do not regard mask-wearing as an encroachment on my civil liberties. I regard it as something that protects me and with which I protect others. We seem to have lost that message in the wearing of masks. Are the Government going to do anything about that?
My Lords, I thank noble Lords very much for an extremely helpful debate, and I very much welcome this return to the Moses Room. It is very nice to be back in the intimate and more conversational style of Committee.
The Secretary of State has been on his feet this afternoon to talk about the toolkit. My understanding is that there will be some kind of Statement repeat, and I look forward very much to going through the toolkit during that. I apologise in advance if I cannot answer every question on that right now, but I would like to tackle a couple of points that were raised. Before I do, I will say a word of appreciation for the contributions of the noble Baroness, Lady Brinton—her presence is highly valued—and for those who organised the virtual House and our current arrangements. It is all a massive compromise and uncomfortable, but I am extremely grateful for the work that has been done to make this return possible. I am hopeful that even more can be done in October.
A number of noble Lords, particularly the noble Lord, Lord Hunt, asked about the booster. The NHS will be rolling out a booster programme to protect those who are most vulnerable to Covid, as we announced previously. It will now be extended to individuals who received vaccination in phase 1 of the programme: that is, JCVI groups 1 to 9. That includes those living in residential care, all adults over 50, front-line health and social care workers, and all those aged between 16 and 40 who have underlying health conditions that put them at a higher risk of severe Covid.
This is very good news. There is very strong evidence that a booster programme such as this can have a very big impact, particularly on those who are immunosuppressed or who live with the immunosuppressed. The JCVI has advised that the booster vaccine programme is offered no earlier than six months after completion of the primary vaccine course, and that will of course affect many people. The vaccination programme has been planning booster vaccinations for some time, which means that the NHS is now in a position to offer booster doses from next week. As most younger adults will have received only their second Covid vaccine dose in late summer, the benefits of booster vaccination in this group will be considered at a later date. I think noble Lords would agree that this is a reasonable and proportionate approach to this complex issue.
(3 years, 2 months ago)
Lords ChamberMy Lords, as my noble friend will know, the training grant of at least £5,000 per academic year per eligible student is in place, plus a further £3,000 of additional targeted funding—for example, for childcare costs and students studying special subjects. That is the kind of financial commitment that we have made to meet his concerns. On the specific point that he mentioned, I say that not everyone is suited for the nursing profession; it is a really tough job, and not everyone who wants to be a nurse can be a nurse. I am afraid that the applications that we get and the sifting that we do reflects that point.
I draw attention to my interests at Whittington Hospital in the register. Thank goodness that our nurses are incredibly resilient, but the relentless nature of working for the NHS, not just in the last year but prior to the pandemic, is now taking its toll. That includes senior and experienced nurses; there must be a worry that many could take early retirement, which is a risk to the profession. The feedback that I get, to which noble Lords have referred, is that respect and regard is less evident as the pandemic continues, and I think that is exacerbated by the debate about pay. What other initiatives is the NHS considering to deal with the fragile nature of retention—for example, housing offers, travel and the working environment—and will they be funded?
The points that the noble Baroness makes are entirely right, and we share exactly the same concerns. That is why we have put in place mental health support, enhanced occupational health support, expansion of the right to work flexibly across the NHS, and the promotion of equality. On the point about older nurses, two things particularly stand out: there is significant investment in leadership through the NHS Leadership Academy, and we have bespoke support for over-50s and newly qualified nurses, recognising that they are likely to be the biggest flight risk across the NHS.
(3 years, 4 months ago)
Lords ChamberMy Lords, the “one health” approach is moving through the G7 process at the moment. I am not sure whether a precise timetable exists. I am happy to check to see whether dates are available, and I will write to the noble Baroness accordingly.
My Lords, it is quite clear that the health and scientific world has, not surprisingly, been focused on the pandemic. The FAIRR report published today and previous reports in this area show what a threat to world health there is from antimicrobial resistance. The question is: how much of a priority is this in the Government’s work? I think that is what most speakers have asked. How much money is the department investing in this area this year and in the next five years?
(3 years, 4 months ago)
Lords ChamberMy Lords, I thank the noble Baroness, Lady Thornton, for her support for the regulations in the round, for her supportive words about the role of the private sector in the round and for raising many important points in her amendment to the Motion, stressing the vital role of NHS testing as we continue to manage the pandemic.
I want to clarify that these regulations are not connected to the future of free NHS testing. This SI, as noble Lords have noted, is solely focused on ensuring the quality of any Covid test in the UK and that they are of the same standards as I would procure for the NHS.
It is self-evident that poor-quality tests, when used privately, could pose a risk to the health of not only the individual but the public. All that is necessary for entry of Covid test products into the UK market is controlled by EU CE marking, which, as noble Lords noted, is currently a self-declaration process for most Covid-19 tests on the UK market. The performance declaration made as part of this EU marking does not need to be independently verified ahead of sale of such tests. There is no legally binding agreed process for establishing performance. That just is not good enough. It became clear as I sought to procure tests at scale for the national effort that many kits that had passed a CE mark were not fit for the real world. I say to the noble Lord, Lord Hunt, that it is not right that the quality of tests correlated to any particular nation; this applied to all nations.
I say to the noble Lord, Lord Alton, that we have audited the supplies of medical devices and there are no current slavery or human rights concerns. We do, however, remain vigilant. I regret that his question on sourcing has not been answered, particularly because there is a very large amount of public material on the procurement framework, the suppliers to it and the arrangements we make to run that framework. I will address that gap with speed, and with regret.
I reassure the noble Lord, Lord Scriven, that there is a very large amount of published material on the internet on the validation of tests, including the protocols and the results from Oxford University and Porton Down, which conducted the validation of the tests. These validation protocols have been assessed by a very large number of experts, and I would be glad to send him links to the protocols and the assessment processes. I reassure him that our tests have been tested against alpha, beta, gamma and delta variants and successfully detect all of them.
The noble Lord, Lord Alton, referenced “kickbacks” to the Communist Party. I very kindly and respectfully ask him to remember that British officials have operated a remarkable procurement programme during the pandemic at the very highest standards of integrity. I gently ask him to provide evidence for such accusations before making them in the House.
To the question of why we buy so many tests from China and not from Britain, the simple answer is that they pass our protocol and meet the requirements of the procurement framework regarding quantity, speed and product design, for example. We buy them to ensure a good deal for taxpayers and effective tests for the public.
I completely agree with the noble Lord, Lord Hunt, that we need a strong UK manufacturing base. I reassure the noble Lords, Lord Alton and Lord Scriven, and others who have raised this point that we have a major programme on this, with subsidies, expertise and support available. I would be glad to arrange a briefing session to run noble Lords through all the measures we have in place to support the UK diagnostics industry. I believe the high-quality regulations we are discussing today provide the certainty business and investors need to invest in the UK diagnostic system. We need this market to provide additional capacity at the time of the pandemic, to ensure that we have outstanding testing capability while also encouraging innovation.
I was keen to take an evidence-based approach to developing this policy, so we ran a very successful consultation that had a broad range of respondents. Some 73% agreed that mandatory validation of tests prior to entry to the market was the best approach; 88% of those agreed that this should be legally backed; 71% agreed that a validation process would not significantly reduce supply; and 79% agreed that mandatory validation processes will increase safety.
In April this year we launched the universal testing offer, so now anyone in England can access free LFD self-tests by ordering online or collecting then at over 9,000 pharmacies across the country. To reassure the noble Baroness and all noble Lords concerned about this, our recently published road map out of lockdown made it clear that we are keeping in place key protections, including free testing for people with symptoms, but we are standing down the workplace testing regime, as the noble Baroness, Lady Thornton, rightly pointed out, from 19 July.
On the rationale for regulation, I welcome the support of the noble Baroness, Lady Thornton, for NHS tests, which have always been of the highest standard. The objective of the legislation is to ensure that the same high standards for tests that we see upheld when the Government buy them are equally reflected in the testing market for all consumers. That market already exists in this country; over 1,000 providers are already going through the UKAS accreditation process. These tests are being used to enable activity across many areas of the economy, including travel, film, TV production and sport. It is critical that we put in place processes to ensure that these tests are high quality and accurate: that is what this law does.
On the integration of private tests and the NHS test and trace system, I reassure the noble Lord, Lord Scriven, and the noble Baroness, Lady Thornton, that significant work has already successfully linked private sector testing results with the NHS Covid app, the JBC and test and trace. When a test is conducted by a testing provider, whether public or private, the result of that test, whatever the outcome, is legally required to be reported to PHE as a notifiable disease by the provider. To the noble Lord, Lord Scriven: this is true for a private test or a public test, and I would be glad to send him a copy of the long-standing regulations that make this law. This must be done within 24 hours for all positive tests. Any self-administered test provided by the Government can be reported via our online portal by members of the public. Any positive test reported to PHE will be passed on to our contact tracing system.
The draft impact assessment has now been published in the interest of transparency, as has an impact statement. It is a living document, and we want to make the best analysis available. We intend to update the impact assessment and address the RPC’s comments ahead of the introduction of the second SI in the autumn. I would like to put on record my thanks to the RPC for working so closely with us and at such pace on this matter.
I want to ensure that all tests are available in the UK, whether they are offered by the NHS, a charity or a private provider, and whether they are supplied by a British diagnostic firm or an overseas firm. I thank the noble Baroness for giving me this opportunity to respond to her important points. I beg to move.
My Lords, I start by thanking the Minister. I feel for the Minister, and I wish him well in his self-isolation, and I congratulate him on his immediate and unfussy decision to obey the ping and the trace system. I hope he is going to have a great summer, because I think he has earned it.
I thank the noble Lords, Lord Hunt, Lord Alton and Lord Scriven, for their support and the questions they have asked. I apologise to the House that we did not put this amendment down in the first place. It should have come straight to the floor of the House rather than going through the Grand Committee first. It was only the gathering concern in Committee that led me and other noble Lords to the conclusion that we needed further discussion about this.
It is not up to the noble Lord, Lord Alton, to prove the veracity of the sources of any goods we purchase through the NHS or anywhere else. If it is being bought by the Government, it is up to the Government to demonstrate that those supply lines are not exploitative and do not use slave labour. That is part of the transparency we are calling for. I do not think the Minister answered very well on that matter.
I am concerned that workplaces, as I suspected, will now have to pay for the testing regime we have. I am somewhat reassured by the noble Lord assuring us that tests have to be fed in through the test and trace system wherever they happen, but I am concerned that, given that workplaces will now have to purchase all those tests, the system will break down quite quickly over the summer. We still have many questions and regrets, so I wish to test the opinion of the House.
(3 years, 4 months ago)
Lords ChamberSurgical hubs are exactly the kind of interesting and progressive medical developments that we need to embrace to get through the backlog; in fact, that kind of specialism creates a huge amount of efficiency for the system and a better service for patients. We are working hard to understand how we can use them more effectively, and I would be glad to write to my noble friend with any details we have on the progress that we are making.
My Lords, the Royal College of Radiologists tells us that 62,000 patients were waiting six weeks or more for a CT or MRI scan, and there may be as many as 45,000 missed cancer diagnoses. There are terrible shortages of skilled staff, fewer scanners than the majority of comparable countries in the OECD—we have half the number in France and a third of the number in Germany—and about a third of our scanners are obsolete or nearing obsoletion. Given the huge waiting list catch-up that the NHS faces, these diagnostic facilities are absolutely vital. Will the Government provide the necessary investment to address this urgent challenge—and in what timescale?
I agree with the noble Baroness that diagnostics is one area where this country needs to make further investment. In the 2020 spending review, we ring-fenced £325 million of capital spending to support NHS diagnostics; the funding will be spent on new equipment, digitising NHS imaging and the pathology networks. New capacity is also coming through the new community diagnostic hubs and pathology and imaging networks. This work is critical, and we are working hard to make sure that it is effective.
(3 years, 5 months ago)
Lords ChamberMy Lords, I apologise for not being clearer; I will be crystal clear right now. Today, you can have a digital certificate on your iPhone, you can have a digital certificate that is printed out from your computer or you can call a number and have a paper certificate sent to you in the post immediately. All of those options are live today.
Disability campaigners are deeply concerned about the integration of health data into cultural participation and worry that the Government’s plans to set up the vaccine passport scheme could undermine the rights of disabled workers and audiences who cannot have the vaccine because of a health condition. What steps are the Government taking to ensure that any scheme that is introduced obeys the seven key inclusive principles, including complying with the Equality Act in making reasonable adjustments to ensure that disabled people do not face discrimination?
My Lords, I am very alive to the concerns of the disabled. We have to balance the need to limit the spread of this virus to save lives, but in a way that is fair and just to all people. We are very much engaged with disability and other charities to ensure that that works. The noble Baroness is right that there will be some people for whom the vaccine does not work and who could yet catch the disease. We need to make provision for those people, and we are working on that.
(3 years, 5 months ago)
Lords ChamberThe nature of the data is very explicitly described in the documents that the noble Baroness will have referred to. If she likes, I would be very happy to send her a full set of details. Of course, many patients have engaged with the process and, like the noble Lord, Lord Young, have made the wise decision to remain enrolled in the system.
My Lords, my honourable friend Jon Ashworth called for this delay yesterday in the Commons. It is not often that we can say thank you to the Minister at such short notice, but it is very welcome that the Government have agreed to this delay. The eighth Caldicott principle—I assume that the Minister is aware of the principles—makes it clear that it is important that there are no surprises for the public around how confidential information about them is used. If GP data can be used by a third party, be they public or private, how will that principle be fulfilled?
(3 years, 6 months ago)
Lords ChamberTo ask Her Majesty’s Government what plans they have to ensure local authorities are informed of new travel guidance on areas where the COVID-19 variant B.1.617.2, first identified in India, is spreading.
My Lords, we are always looking to see how we can communicate more effectively with local authorities. We will have discussions with local authority colleagues this week to make sure that everyone is clear what the expectations are and how we can improve communications going forward.
My Lords, to paraphrase Matt Lucas as the Prime Minister: “Don’t go to work—go to work. If you can stay indoors, go outside. Don’t go outside—go on public transport. Don’t go to work and then—something or other will happen.” It would be laughable if it were not so serious. I have two questions for the Minister. The amended guidance asks people to minimise travel into and out of the eight hotspot areas. The previous version asked them to avoid all non-essential travel. What is the difference between those two things or is it like the amber countries—you can go there but you should not? If the Government want people to heed their advice, guidance or instructions, why were the notices posted on a website during the night without consultation or accompanying dissemination to people and organisations such as public health, councils and mayors? That does not seem the most effective way to communicate with people.
My Lords, the characterisation presented by the noble Baroness is unfair. We are trusting people to be responsible and to act with caution and common sense, as they have done throughout this pandemic, and to make decisions on how best to protect themselves and their loved ones. We are seeking to avoid bringing these measures into law and instead are using guidance. The communication of that guidance could have been done better but we are working extremely hard with regional partnership teams, Public Health England, local authorities, JBC colleagues and the incident management teams to ensure that these communications are done in the most effective way possible.
(3 years, 6 months ago)
Lords ChamberMy Lords, we can probably all agree that the Minister has drawn the short straw today—and not for the first time, I think.
The issue I want to raise on this Question is that the Government took powers in the road map legislation to impose local lockdowns, so I ask the Minister: are any discussions taking place about whether those powers will be activated in those areas? Secondly, we know that a single dose of the vaccine is less effective against this particular variant, so I repeat the question asked earlier: what plans are there to increase vaccination in the areas most affected by the spread of the Covid variant B16172? Will the Government produce a plan with the local directors of public health to roll out the vaccines to everybody in those areas, and consider including bringing forward a second dose for a larger cohort of people?
My Lords, the noble Baroness asks two very pertinent questions which slightly answer themselves, in a way—but let me try to update the House on our plans in that area. She is right that we have powers on local lockdowns, but that is not the focus of our thinking at the moment. Local lockdowns are an important tool, but not one that we think is a priority right at this moment. We are focused on the vaccines. It is beyond doubt that this Indian 2 variant particularly hits those who are not properly vaccinated—and by “properly” I mean “have had two doses and two weeks”. Those who have forgone either their first or second dose are particularly vulnerable, and you have only to look at the infection data and, particularly, the hospitalisation data to understand that.
That is why we have rolled out surge vaccination in those areas. What that means is a huge amount of communication, a huge amount of engagement with the communities and the presence of various mobile vaccination units sent directly into the heart of the communities to provide different channels and mediums by which people can step up for their vaccine. The response has been extremely strong and I am touched, as I have said, by the videos of people in some of those communities, particularly in Bolton, where people have queued up for their vaccines. I pay tribute to the DPHs and local authorities that have facilitated that programme.
(3 years, 6 months ago)
Lords ChamberMy Lords, we estimate that there are currently just eight patients in Northern Ireland who would benefit from the expanded use of Tagrisso for early-stage disease. Perhaps I may reassure my noble friend that they will all have the same access as in the rest of the United Kingdom without any delay or restraint on that access.
My Lords, we should all wholeheartedly welcome the news of the agreement to enable early access to Osimertinib for early-stage lung cancer patients in England and I absolutely recognise that it is also available to patients in Northern Ireland. However, early diagnosis is as important as access to treatment. It is therefore deeply concerning that the number of people in England and, presumably, across the UK being seen by a specialist for suspected cancer, following urgent referral from their GP, has dropped dramatically. What steps are the Government taking to bring those waiting lists down? We certainly cannot wait for a reorganisation of the NHS, as proposed this year. Does the noble Lord acknowledge that reorganisations tend to have a chilling effect on the recovery of our NHS?
The noble Baroness is entirely right to be concerned about the backlog of oncological diagnostics. It is of grave concern to all of us. That is why the NHS has massively prioritised the tests she described. We are working extremely hard to get through the backlog. GPs are extremely focused on identifying those most at risk and those who are late for their tests are being followed up with great energy and endeavour. I pay tribute particularly to the role of NHS D, which is using the kind of data gains that we made during the pandemic to mobilise all the technology we can to get the right people into tests at the right time.
(3 years, 6 months ago)
Lords ChamberMy Lords, undoubtedly, the increase in referrals is something of concern. It is something we are monitoring closely, with the round table and the ministerial group dedicated to looking at this. That shows the seriousness with which we regard it. The reduction in the impact of community services, which is the best way of addressing these kinds of issues, has undoubtedly had an effect on urgent needs. During this period, there has also been a large increase in the number of young people who have started treatment, which is encouraging. If the noble Baroness has evidence that measures such as nutrition information on packaging has an effect on anorexia, I would welcome correspondence from her.
My Lords, as the noble Baroness has said, we know that eating disorders among children and young people have increased during the pandemic. There is a very welcome increase in the grant of £11 million from the grant in 2018-19. Despite this, total spending by CCGs on children and young people’s community eating disorder services increased by just £1.1 million, from around £54 million in 2018-19 to £55 million in 2019-20. This increase is cancelled out if you adjust for inflation, and this means that total spend flatlined in real terms. What are the Government going to do to ensure that this money is spent on what is growing into an epidemic of eating disorders and the suffering they cause?
My Lords, the noble Baroness is entirely right that community eating disorder services are critical. They are the backbone of our measures to address these difficult cases. But money for the treatment of eating disorders comes from many different pots. During 2021, a total of 10,695 children and young people started treatment, which is up from 8,034 children in the year before. So, clearly, resources are getting through to cope with a large number of people, and that is an encouraging sign.
(3 years, 6 months ago)
Lords ChamberMy Lords, there is already considerable co-ordination between the department, DCMS and DfE on exactly that. I highlight the money that has gone from the tax on soft drinks to contribute to funding outdoor activity in schools, which has had an enormous impact. My noble friend is entirely right that physical activity is linked to better health outcomes; that is why it will form part of the agenda for the Office for Health Promotion.
My Lords, the policy paper does not reference the measures proposed in the childhood obesity plan and the recent Tackling Obesity strategy released last July. I hope that omission is not significant. Can the Minister confirm—I was slightly concerned by his response to the noble Baroness, Lady Jenkin—that the ban on online adverts for foods high in fat, sugar and salt has been watered down? In awaiting the consultation from the advertising industry, is that a “whether” or a “how”?
My Lords, consultations are there to have an honest conversation. It would be wrong for me to try to pre-empt the outcome of that consultation from the Dispatch Box.
(3 years, 7 months ago)
Lords ChamberMy Lords, I recognise the challenge to which the noble Lord refers. It is, of course, a fact that coronavirus restrictions in Northern Ireland are determined by the Northern Ireland Executive as part of the devolution settlement, as I am sure he would recognise. The Secretary of State for Northern Ireland has raised the issue with the Irish Foreign Minister on a number of occasions to press for a resolution, and while the UK Government continue to work closely with the Executive to drive this virus down, we respect that healthcare is a devolved matter. This is a complex issue to resolve, but we are extremely grateful to all parties who are working hard to resolve it.
My Lords, the truth is that the Northern Ireland Health Minister, Robin Swann, found out that there were cases of the Indian variant of the virus in the Republic of Ireland only from media reports. This is deeply concerning, as was raised by the noble Lord, Lord Dodds. Northern Ireland is part of the UK, so we have the same responsibilities to our fellow citizens in Northern Ireland and therefore it is very concerning. Is the Minister confident that, going forward, mutually beneficial data-sharing processes are in place to ensure that new variants are controlled and do not become seeded and spread in any of our communities?
My Lords, I am enormously grateful to the Irish Government for the very large amount of informal clinical data-sharing that goes on. CMOs of both countries exchange data on such matters as VOCs the whole time, and that kind of day-to-day clinical exchange of on-the-ground information works extremely well. The specific question of travel information is a lacuna that needs to be closed, I recognise that it needs to be shut, a lot of work is going on to shut it and I am grateful to those involved.
(3 years, 7 months ago)
Lords ChamberMy Lords, I would be glad to take the noble Lord’s recommendation back to the department; he puts it extremely persuasively. As I said, we have looked at the substantial point closely and it is extremely persuasive, as the noble Lord rightly put it. We hope to come forward with recommendations as soon as the elections are over.
I reinforce what my noble friend Lord Rooker said. I may be addressing this with my third or fourth Minister. I am not certain whether the noble Earl, Lord Howe, dealt with it when I was opposite, but he may have done, which would make the noble Lord my fourth Minister on this issue. It is even more irritating that it was research in the UK that led the United States and other parts of the world to adopt this policy. I think The Minister has run out of road on this one, and I would like to hear what the timetable to implement this policy is.
I completely endorse the tribute of the noble Baroness to those who have worked on this policy. She is right: the science that has gone into this has been persuasive around the world. I thank those in industry who worked with us on our pilot, which proved extremely successful. We are in good shape when it comes to thinking through the implementation of such a policy. My hands are tied at the moment, because of purdah, but I hope to return and fulfil the noble Baroness’s wishes.
(3 years, 7 months ago)
Lords ChamberAs the noble Lord rightly points out, the cost is enormous: £27 billion is the estimated cost to society, and 64% of people are classified as overweight. The challenge is enormous. We have to strike the right balance between government action and personal agency. The noble Lord is right that the return on investment is huge, but the Government cannot lose weight for people on their behalf. No amount of government initiative will shed the pounds. We have to get people to change their behaviours. We are trying to understand what the right measures are to give people the inspiration and information they need to take the right steps.
My Lords, this Government’s proposal is the 14th government obesity strategy since 1992. Despite 689 policies having been introduced in the past 29 years, obesity rates have increased. Another major indicator is deprivation. Children from deprived areas are twice as likely to be obese as children from the richest areas, as acknowledged by the Government’s strategy. However, the strategy was criticised for not going far enough on poverty. Healthy foods are three times more expensive per calorie than less healthy foods. Can the Minister address this grave and vital matter of people from lower socioeconomic backgrounds not having access to, and being unable to afford, healthy and nutritious food?
My Lords, I agree with the correlation pointed out by the noble Baroness. We must acknowledge and address the fact that areas of deprivation undoubtedly have higher levels of obesity. However, we have to be careful about taking away people’s sense of agency. It is possible to buy affordable healthy foods at any price point. Food has never been cheaper than it is today. We must put into people’s hands the knowledge and inspiration to take the steps necessary to shed the pounds that need to be shed.
(3 years, 8 months ago)
Lords ChamberMy Lords, we will address the audit points made by the noble Baroness. I completely endorse the importance of training; that is at the heart of the report and we acknowledge its importance. We are concerned about the number of people with learning disabilities who have died during the pandemic, and there will be a report on what the connections are.
My Lords, we know that it is unlawful for DNACPRs to be imposed, and I wonder why the research has not sought to identify why physicians and care workers continue to impose them in the way that they have. Does the Minister agree that the solution must lie in completely clear, unambiguous policy to advance care planning and DNACPR decisions, and a consistent use of accessible language, communication and guidance to enable clear understanding by commissioners, providers and the public?
I will gently push back against the noble Baroness: the policy is absolutely crystal clear. Blanket DNACPR is not the policy of this Government, as was repeated time and time again in our communications, which I would list if I had more time. Training is the issue: we need to give the front-line workforce the skills it needs to apply these very delicate but critical interactions. That is the recommendation of the report, and that is where we are focused on applying the lessons.
(3 years, 8 months ago)
Lords ChamberMy Lords, the Minister will be aware that 100 contracts remain unpublished, while those that have been published are so heavily redacted that it is impossible to ascertain whether the orders reflect value for money for the taxpayer. Procurement guidance, which is still in force, says that once the contract is commenced, most of the contact details should be released and that only detailed pricing arrangements should be redacted and not much else. Indeed, Cabinet Office guidelines say:
“The government is committed to greater transparency across its operations … This includes commitments relating to public procurement.”
Can the Minister explain to the House and propose how meaningful transparency can be achieved to give effect to the Government’s stated policy?
My Lords, with regard to the publication of contracts, the number of contract award notices that have been published is 609 out of 609. For contract finder notices, it is 892 out of 913—97.7%—and of the redacted contracts to which the noble Baroness refers, it is 792 out of 913, which is 86.7%. That is an enormous proportion of the contracts that exist that have already been published. The redaction is utterly according to Cabinet Office guidelines. I encourage the noble Baroness to have a look at them; it is remarkable how much detail there is in those contracts as they are published.
(3 years, 8 months ago)
Lords ChamberMy Lords, we are extremely hopeful for the IPPPR process, and we have supported the team in its desire to get to the bottom of its investigations. I do not know the specifics of the bat viruses to which my noble friend refers, but I reassure him that the British Government are leaning on the WHO as hard as we possibly can to make the most of this important investigation.
Given the cuts to the aid budget which have been announced, and given that experience shows that the world’s reaction to pandemics is to panic and then forget—which Covid-19 has cruelly exposed—can the Minister expand on how HMG are going to support the World Health Organization to address the immediate urgent work to fight the pandemic and to build for the future the firepower and structure to better handle an issue of global magnitude under the Government’s current budget constraints?
My Lords, the financial support of the WHO from the Government is generous, and so is our support of COVAX. When it comes to the WHO, we are looking for stronger horizon scanning and early warning, higher-quality technical guidance that is tailored to different countries and resource settings, and greater co-ordination of governance and activity across the animal, human and environmental interface. This is a really clear manifesto. The Prime Minister has laid it out clearly, and we are using the G7 process to ensure that there is support for it across the G7 countries.
(3 years, 8 months ago)
Lords ChamberMy Lords, I completely endorse the right reverend Prelate’s point about the heroics of—and the debt that we owe—nurses, but I just cannot agree with him that the best way of recognising the contribution of nurses is to give them a pay increase. That simply is not my experience of workplace engagement. Yes, pay rises are important and a recognition of work done, but there are other, much more important reasons why people work. They work for the status of that role, for the opportunities that it gives them in their life, for the security that it gives them and for the collaboration of working with fellow members of staff. There is a whole package of reasons why people do the work that they do. We live in extremely economically challenging times. It is right that the advice given to the pay review body looks at the entire package, not just at the pay increase.
The Minister is quite right: it is not just about the 1% rise. A newly qualified nurse will earn £21,000 in 12 months; that is their starting salary. The consultants building the track and trace system, at £7,000 an hour, earn more than that amount in under four hours. Perhaps that will help the Minister understand why so many people are outraged at the proposed 1% so-called pay rise. Will he explain to the House what values and priorities he holds that lead him to believe that the Government’s decision is an acceptable one?
My Lords, the noble Baroness makes some vivid comparisons on completely incomparable pay differentials. The values that we have are absolutely aligned with public service values. We are determined to create a workplace that is just, fair and equitable. We are committed to giving people a fair reward for the work that they do and to giving people decent job prospects within that role. Those are the values that people go to work for and are motivated by. We need to put together a package that works across the piece and is not narrowly focused on one particular material point, such as pay. I stand by what I said previously: the package of measures that was put in our evidence to the pay review body sees all those values in the round.
(3 years, 8 months ago)
Lords ChamberI am grateful to the noble Baroness for her tribute to my noble friend Lord O’Shaughnessy, who has done an enormous service to us all by championing this cause, both as a Minister, when he moved this review and made a huge impact, and since then with his patient and thoughtful advocacy of this important cause. He speaks very movingly and thoughtfully, and we are greatly influenced by his persuasion on this subject. The noble Baroness should be reassured that we are absolutely looking at the recommendations for a redress agency, and we will come back with considered thoughts on it when we answer the review in the round. Until then, I welcome all thoughts and advocacy on the subject.
I have two points. First, last summer only 41% of the respondents taking valproate said that they had signed an annual risk acknowledgment form, so I would like the Minister to reflect on the fact that some GPs are not doing the job that they should be in terms of protecting women. Secondly, those affected by thalidomide and contaminated blood have a redress scheme, but it took years for that to happen. We simply cannot wait years for this to happen for those suffering from the effects of sodium valproate.
My Lords, I welcome the noble Baroness’s point on the proportion of those who say they have filled in the form. Phase 1 of the registry is a helpful collection of statistics, but we are putting in place phase 2, which will help us to understand exactly how many patients who are taking sodium valproate have actually filled in the form. That will give us the concrete reassurance that we seek on this matter. I recognise that there are redress payments for thalidomide and contaminated blood, but redress payments are not necessarily suitable for every single misfortune that happens in the medical world. However, we will look very carefully at the case for sodium valproate and I take the noble Baroness’s comments on board.
(3 years, 8 months ago)
Lords ChamberMy Lords, the challenge we have is uncertainty. Genomic sequencing data links the Brazilian variant to the South African variant, the so-called E484K mutation. We also acknowledge that there are anecdotes from Manaus on transmissibility, but none of this is clear cut. We are working towards getting the concrete data necessary to make a confident assessment of this mutation. Therefore, we are taking a precautionary approach and we are committed to limiting its spread by all means at our disposal.
I thank the Minister. According to a report by the World Health Organization, the P1 variant that originated in Brazil has been found in at least 15 countries which are not on the Government’s red list, meaning that arrivals from those countries are currently exempt from the hotel quarantine policy. Virologists have warned that the Government’s red list is at risk of becoming out of date at any time because of the time it takes to sequence coronavirus cases. Indeed, these six cases date back to 11 and 12 February. In the light of these facts, and given concerns that the Brazilian variant may be more transmissible and might be resistant to existing vaccines, will the Government review the red list and take urgent action to introduce a comprehensive hotel quarantine system that applies to all UK arrivals?
The noble Baroness is entirely right: this is not the first case of P1 in Europe. As of 11 February, P1 has been identified in 17 countries, with 200 cases reported globally. In the EU, 30 cases have been identified in five countries and areas. We keep the red list under permanent review and have an ongoing process of keeping it up to date. The fact that we have a red list and a managed quarantine programme makes further expansion of the red list possible. It puts our borders and our vaccine under a programme where we can control things, which is to be applauded.
(3 years, 8 months ago)
Lords ChamberMy Lords, a year ago, Parliament gave the Government huge power so they could act quickly in the face of the pandemic. Unfortunately, growing evidence suggests that Ministers have taken advantage of these powers to the disadvantage of the taxpayer and to the cost of health workers and patients. The NAO report in November revealed that the Government set up fast-track systems for billions of pounds of contracts for people personally known to Ministers, Peers and MPs. They found that suppliers with links to politicians were 10 times more likely to be awarded contracts than those who had applied to the department in the normal way.
It looks like there is more to be explored here: not just a case of “delayed paperwork” as the Health Secretary has claimed but serious procurement rule breaches. Will the Government urgently publish the names of all companies awarded public contracts through the VIP lane and how much they were paid? What steps are the Government taking to recover millions of pounds of public money from companies which failed meet their contractual obligations?
My Lords, I am grateful for the question from the noble Baroness, Lady Thornton. During those hectic days, more than 15,000 suppliers approached us. Many of them were credible, but many sadly were not. It was entirely right and the best practice to have a high-priority lane to triage and prioritise those who were the most credible. A sample of 232 suppliers in that lane reveals that 144 came from Ministers, 21 from officials, 33 from MPs and 31 Members of the House of Lords not in the Government—including many who chose to write to me personally with the names of recommendations. I am enormously grateful to those who got in touch.
(3 years, 9 months ago)
Lords ChamberWe have to work with what we have. The existing register, while not perfect, is the tool that we have for our task. GPs had been encouraged to update registers in advance of the vaccine, as we had several months of knowing that it was coming. I understand that considerable work has gone into that. With regard to carers, my understanding is that they are not currently included in the clarification that came out today, but I am happy to confirm that point with her.
My Lords, we all want our children back at school on 8 March, and the Government need to do everything possible to keep children learning, with testing systems that work, ventilation and the use of Nightingale classrooms. The Government missed the opportunity to vaccinate teachers at half-term, so I ask the Minister to explain why, if our children are to be back at school on 8 March. When will teachers and support staff be a priority for vaccination?
My Lords, teachers are a priority in as much as they are on the prioritisation list along with other key workers, but the honest assessment of the JCVI is that teachers are not at accelerated risk of increased sickness or hospitalisation over any other member of the public. We are enormously grateful to the teaching profession for the role it is playing in getting schools back and in testing but, in terms of sickness and mortality, teachers are in the right place in the JCVI prioritisation.
(3 years, 9 months ago)
Lords ChamberMy Lords, I am across the recent outbreak of chicken nugget salmonella poisoning across the UK. However, I point to the work of the European distribution fraud unit, which is very much focused on this kind of cross-border food crime. I will take back to the department the noble Baroness’s recommendation and will write to her if there is any update that I can provide her with.
I will be very quick because I am very keen that the noble Lord, Lord Krebs, is able to get in on this Question. Can the Minister commit to briefing parliamentary counsel to advise and bring forward these changes, and when can that happen? We on these Benches would welcome this commitment and would give appropriate support to the resulting legislative process.
I am enormously grateful to the noble Baroness for her support in this matter. I reassure her that we are focused and working on it, and I will bring forward an update as soon as I reasonably can.
(3 years, 9 months ago)
Lords ChamberMy Lords, I confess that I did not know about that association. I am not sure whether it is correlation or causation, but I completely support the noble Baroness’s observation that oral hygiene is critical, and we should put the steps in place to improve the oral hygiene of the nation.
I think the Minister needs to go back to the drawing board, because the new NHS activity target is basically forcing dentists to choose between check-ups and helping those in pain. That cannot be right. It can only increase health inequalities, let alone deal with the gigantic pandemic backlog. In secondary care, there is the particular problem of patients needing general anaesthetic for their dental treatment. These are mostly children and learning-disabled adults. There was already a waiting list of a year before the pandemic. Could the Minister inform the House how many patients are on this waiting list now? If the Minister does not have this information, could he please write to me? Do the Government have a plan to reduce this awful, and obviously very painful, waiting list?
My Lords, I do not necessarily accept the dichotomy the noble Baroness refers to. I think it is reasonable for dentists to triage patients between those who can be treated with either advice, analgesics or antibiotics, and therefore do not need face-to-face contact, and those who need to be prioritised to, for example, the urgent dental care centres. I commend the dental profession for making good choices in that area. With regard to the treatment of children using anaesthetics, those are not statistics I have to hand, but I would be glad to write to the noble Baroness with whatever information we have.
(3 years, 9 months ago)
Lords ChamberMy Lords, of course, employees should be working from home wherever possible, and that is why our focus has not been on this area to date. I emphasise that on Monday the community testing part of Test and Trace issued a call to all those employers of more than 50 employees where it will provide free testing kits for those interested in using workplace testing. This is going to be an essential part of our fight against Covid in the future, and we look forward to working closely with the CBI and other employer groups to make sure that the rollout happens efficiently.
I am puzzled, because the studies by SAGE estimate that the levels of compliance were between 18% and 25% and that people earning less than £20,000 a year or who had less than £100 in savings were three times less likely to self-isolate. I repeat what other noble Lords have said: what plans do the Government have to fix statutory sick pay so that people who self-isolate have the proper financial support that they need? Also, how many people have applied for the £500 grant and how many people have been awarded it?
(3 years, 9 months ago)
Lords ChamberMy Lords, the priority list from the JCVI indicates that all residents in care homes, older adults and those over 80 will be first. But, with the current state of the rollout, all those over 65 should have been offered a vaccine, and I encourage them all to step up and respond to the letter when they receive it.
I would like to ask the noble Lord about domestic abuse. Next year, ONS data collection will, for the first time, include those aged over 75 who suffer from domestic abuse. That is an important step forward. However, the pandemic has meant that many older people at risk of domestic abuse are indeed isolated and at risk. So what steps are the Government taking to collect data on the impact of domestic abuse on over-75s during the pandemic and to ensure that appropriate support is in place for older victims and survivors?
My Lords, the noble Baroness makes the point extremely powerfully. Of course, our prevailing feeling is of admiration for all those who have, through love and companionship, cared for those who are shielding or at home. But of course, as the noble Baroness alludes to, there are instances when, through either domestic tension or simple abuse, there is violence, and we cannot hide from that fact. I am not aware of a current trial or piece of research on this matter but I will take it back to the department and undertake to write to the noble Baroness with an update.
(3 years, 9 months ago)
Lords ChamberMy Lords, I am very grateful to the Minister and his team for the manner in which they have engaged and worked with us throughout the passage of this Bill, particularly at this final stage. The amendment in lieu is a good compromise that reflects the need for scrutiny to be at the heart of the Bill. It provides a mechanism to examine the powers of the Act in five years’ time and will open the door for the restructuring and consolidation of the post-Brexit medicines and medical devices regulatory regime. We believe that this will prove both desirable and necessary, and look forward to working with the Minister on such issues when the time comes.
We welcome the requirement that the Secretary of State must specifically consider whether this should be in the form of primary or secondary legislation and hope that this will lead to policy being put into a future Bill rather than scrolled away in regulations. The Secretary of State will also have to take account of all parliamentary committee reports. This would include post-legislative scrutiny undertaken by a Select Committee, as well as the DPRRC and Constitution Committee, whose oversight played a crucial role in reshaping a skeleton Bill into a framework Bill; I thank the noble Lord, Lord Lansley, for explaining that to us all. I hope the Minister can assure me that stakeholders will also be consulted. I am sure that that will be the case. It is very important, given that they are the end users of the legislation, and for the report to have value and credibility it must reflect the experience of regulators, industry, patients and medical professionals.
Finally, the tidying-up amendment that retains the requirement to share information in the public interest is an important provision because it will allow for substantive and ethical issues relating to the sharing of public data to be considered. This is of the utmost importance, given the role that the NHS and patient data may have in future trade deals.
My Lords, I do not intend to repeat much of what I said at Third Reading. Many thanks to the noble Lords who have contributed to the changing shape of the Bill. From Committee to ping-pong, we have listened, heard proposals for change and brought workable, practicable compromises forward.
I wish to repeat the remarks made by the noble Baroness, Lady Thornton. She congratulated all of us on the effective communication that has made it possible to make considered progress on this Bill, despite all the challenges that Covid-19 has presented us with. This a very fair assessment; I agree with it completely. From the report of my noble friend Lady Cumberlege to the demonstrated expertise of our medicines regulator, the MHRA, we have seen the importance of patient safety, clinical trials, our life sciences sector and effective regulation bear out in our hospitals, clinical trials and patient community.
I look forward to the debates ahead of us on the regulations that will be made under the Bill. They will be important, as we set forward on our course for the best possible regulatory regime for the UK, with the patient at its heart.
(3 years, 9 months ago)
Lords ChamberTo ask Her Majesty’s Government what plans they have to ensure that the second dose of the Pfizer/BioNTech COVID-19 vaccine is delivered to patients within 12 weeks of receiving the first dose.
My Lords, the second dose completes the course and is vital for long-term protection. That is why all patients will be offered a second dose between 77 and 84 days after receiving their first. We have already vaccinated almost 9 million people, with the ambition to reach the 15 million people in the most vulnerable groups 1 to 4 by the middle of February.
I thank the noble Lord for his partial reassurance; however, the question is actually whether there will be a supply available in the timeframe. Given that any unvaccinated area provides a potential pool for new strains of Covid to develop and re-infect the world, extending immunisation to the whole world is not
“only a matter of altruistic engagement,”
but “of enlightened self-interest,” to quote Tony Blair. Does the noble Lord agree that countries must come together to reject vaccine nationalism in favour of co-operation? At what point in terms of vaccination of priority groups will the UK be able to make vaccinations available to other countries that are in need?
I completely agree with both the noble Baroness and the former Prime Minister Tony Blair on this matter. Not only must we vaccinate our own country, but we are not safe until the whole world is vaccinated. That is a basic public health and epidemiological observation. It is why we are very committed to international efforts—to CEPI, Gavi, COVAX and ACT. They are all working hard to get fair distribution of vaccines. We have also put £571 million into the funds at COVAX to support vaccines for the developing world. However, we have to start at home and it is not possible to make a commitment on the schedule for when we will be in a position to think about exporting vaccines until that is completed. When it is completed, I will update the House accordingly.
(3 years, 10 months ago)
Lords ChamberMy Lords, the Bill before us is quite different from the one we started with, but it is no doubt much better. That is entirely because of the huge value of your Lordships’ challenge and scrutiny. We have held over 50 meetings and considered 249 amendments, and the result is a tribute to the care and patience of noble Lords, for which I give profound thanks. It is also, if I may say so, a tribute to the workings of the hybrid House, which have kept legislation moving under difficult circumstances.
We would not have reached this position without the thoughtful, collaborative and constructive input of noble Lords, to whom, I pay tribute—in particular, to the noble Baronesses, Lady Thornton and Lady Wheeler, on the Opposition Front Bench, together with the noble Lord, Lord Hunt, and the noble Baronesses, Lady Jolly and Lady Walmsley, and the noble Lord, Lord Sharkey, on the Liberal Democrat Benches. I also thank, from the Cross Benches, the noble Lords, Lord Patel and Lord Alton, and the noble Baroness, Lady Finlay. They have all brought their immense experience and wisdom to our debates, to improve this legislation. And when it comes to wisdom and experience, I must also pay tribute to those from these Benches, especially my noble friend Lord Lansley, my predecessor, my noble friend Lord O’Shaughnessy, and my noble and learned friend Lord Mackay of Clashfern, who have all been of enormous help in enabling us to arrive at a consensus across the House. My noble friend Lord Howe has been a generous mentor, and my noble friend Lady Penn is a superlative Whip, both shepherding the process charmingly, discreetly and effectively.
I thank most emphatically my noble friend Lady Cumberlege. She has spoken of the importance of compassion, of the voices she has listened to, and of the paramount importance of patient safety. I have heard her, and I support her endeavour. She has the support of the House in her efforts, and we have collectively made significant progress towards her admirable goal.
I also thank officials on the Bill team, particularly Alice Clouter, and those in my private office, particularly Tilly McEwan. They have all worked tirelessly and expertly. I cannot give thanks to all the other champions in the House who have made influential interventions, but I am definitely very grateful to them.
I cannot hide my excitement about the future. While the Bill process is near its conclusion, we are at the end of the beginning of an exciting new regulatory system—a system that protects patients and enables innovation. It is with that vision of the future, as well as my gratitude to all, that I beg to move.
My Lords, at this stage of the Bill, we take a few moments to congratulate ourselves and thank those who have made it possible to get this far. First, I thank my own Bill team, who have worked so hard, particularly Rhian Copple in the Lords Opposition office, and my noble friends Lady Wheeler and Lord Hunt—and, indeed, my noble friend Lady Andrews and others, who popped up here and there to support us.
We should all congratulate ourselves because, despite the conditions in which we have worked this autumn and winter, we have managed to build effective communications which have made it possible to make considerable progress in improving the Bill in many ways, as the Minister said. I think we can say that we did our job, as the revising Chamber.
The fact that we ended up with only three Divisions on Report is a testimony to way in which the Minister, the noble Lord, Lord Bethell, his Whip, the noble Baroness, Lady Penn, and his adviser, the noble Earl, Lord Howe, and the very hard-working Bill team led by Alice Clouter, handled the Bill. They listened, they discussed, they considered and they revised, which is really all that one can ask. This is the Minister’s first Bill, and I congratulate him on leading his team and handling what is always a baptism of fire for any Minister.
I am delighted to agree with the Minister and say that we are sending back a very different, and much improved, Bill. We have managed to address many of the big-ticket items, ranging from data sharing to human tissue, and, ultimately, patient safety. I thank participants across the House. Like the Minister, I mention in particular the noble Lord, Lord Patel, the noble Baroness, Lady Jolly, the noble Lords, Lord Freyberg and Lord Clement-Jones, and the noble Baroness, Lady Cumberlege. I also thank everybody else who has taken part in the many discussions and given us the benefit of their wisdom, particularly the noble Lords, Lord Lansley and Lord O’Shaughnessy.
First Do No Harm paved the way for the creation of an independent patient safety commissioner, and I think that changed the way in which the Bill was handled, because it is now, as it should be, a patient safety Bill. For that, I really wish to congratulate the noble Baroness, Lady Cumberlege.
Finally, I want to thank the organisations who have given us their support and expertise, which is particularly important for those of us in opposition. I am very grateful to the DPRR and Constitution Committees for their insightful scrutiny, which sometimes is painful for the Government but is almost always helpful to us; the Lords Library; and, for us, the University of Birmingham, the British Dietetic Association, Advanced Accelerator Applications, the Association of British HealthTech Industries, Cancer Research UK and, in particular, the BMA. I am very grateful for the expert briefs that they have given us.
Stakeholder engagement will remain key for many years to come, for while the Bill will soon pass—as the Minister said—the task of creating a post-Brexit medicines and medical devices regulatory regime is far from finished. I look forward to working with stakeholders and the Minister to make sure that we move forward in the best possible fashion. We have given ourselves a good start.
(3 years, 10 months ago)
Lords ChamberMy Lords, the noble Baroness puts her point very well. There is a huge amount of sympathy and concern for those who have underlying conditions, and she is right that ONS data on those with underlying conditions demonstrates a higher hospitalisation and mortality rate. That is why we have put all individuals between 16 and 64 with underlying health conditions that put them at a higher risk of serious disease and mortality higher up the prioritisation list than others. However, it is age more than anything else that is the greatest determinant of morbidity, and that is why the list looks the way it does.
My Lords, I would like to ask the Minister about those who are housebound and bedbound. If their domiciliary workers, care workers and unpaid carers are vaccinated in centres and with their GPs, what arrangements are in place for home visits to vaccinate this particular cohort of people, who cannot leave their home because of their disability or their particular conditions? It has been rumoured that there is no intention to vaccinate this cohort at present, which I find remarkable. So I would like the noble Lord to assure the House that arrangements are being made for this particular cohort.
My Lords, I reassure the noble Baroness that it is absolutely not our intention to leave those who are housebound out of the scheme—not at all. In fact, they are an important priority. They are logistically a big challenge. We are in a numbers game. We are trying to get the greatest number vaccinated as quickly as possible. However, we are working extremely closely with community pharmacists and GPs to try to figure out the way in which we can get the vaccine to people who cannot make their own way to a vaccination centre. Those plans are in advanced progress. I do not have details of them to hand, but I would be glad to write to the noble Baroness with those details.
(3 years, 10 months ago)
Lords ChamberMy Lords, NHS England is working with Health Education England to procure training courses that will increase the capacity of the existing workforce, to allow them to understand these challenging issues better and allocate people to the right course of treatment. It is a problem that we recognise, and resources in training are being put in place to address it.
My Lords, following on from the last question, hospital admissions for bulimia rose 75% during lockdown, amid fears about the mental health impact of the pandemic. For children and young people, we also know that these figures have been rising every year for several years. We also know that there are regional disparities in waiting times for eating disorder services. What will the Government do to respond to what seems like an increase in eating disorders and rising regional disparities?
My Lords, I recognise the issue of regional disparities, but I reassure the noble Baroness that our ambition is to deliver swift access to treatment for 95% of children and young people with suspected eating disorders within one week. The good news is that in the second quarter of 2021, 83% of urgent cases were seen within one week and 89.6% of routine cases were seen within four weeks. Those figures can be improved but I think that they are impressive. They show that progress is being made and that we are taking this issue seriously.
(3 years, 10 months ago)
Lords ChamberMy Lords, what a helpful and instructive debate, and I thank all noble Lords who were involved.
In December 2020, we witnessed a landmark moment in our battle against Covid: the launch of an effective and safe vaccination programme, which has yielded great results. Thankfully, confidence in vaccines remains very high across the UK. None the less, some citizens have questions and there is a prevalence of misinformation. It is therefore absolutely and entirely right that we should answer those questions in the spirit of constructive dialogue, which is exactly what we seek to do.
I completely share the aspiration of the noble Baroness, Lady Bennett, for Covid to be an inflection point in a business model moving away from late-stage acute medicine toward prevention. Vaccines play an absolutely critical role in that, and this could be a profound legacy of this awful disease.
Despite all this, I completely recognise that we have also seen a range of baseless and sometimes absurd narratives being shared, particularly through social media platforms. It is completely unacceptable that a minority of people seek to exploit legitimate questions about vaccines and spread dangerous lies about vaccines for their own malicious reasons and profit.
Noble Lords will agree that it is vital that both misinformation and disinformation about vaccines are tackled. Before I address the Government’s response on how we will handle these two challenges, I pay tribute to the cross-party alignment on this issue and the spirit in which the noble Baroness, Lady Thornton, moved her amendment. Noble Lords from all sides of the House have shown a strong commitment to tackling anti-vax conspiracies and I express profound thanks for this tremendous collective effort, of which we can all be proud.
Throughout this pandemic, we have remained committed to transparency around the vaccine and to ensuring that people have access to accurate information about the virus and vaccines. DHSC is leading extensive cross-government communications activity, providing advice and information to anyone who has questions about the vaccine.
I do not think it would be helpful for me to run through our efforts in this area in detail, but I reassure noble Lords that we have worked, and continue to work, extremely hard to rebut false information online. In March 2020, we stood up the Counter Disinformation Unit, bringing together cross-government monitoring and analysis capabilities to tackle misinformation and disinformation. The Government have worked tirelessly to act wherever false and harmful content appears on social media platforms, either by flagging the content to the platforms or through direct rebuttal on social media via our Rapid Response Unit.
We are particularly committed to dialogue with and the protection of communities that might be particularly susceptible to disinformation and which, coincidentally, are particularly vulnerable to the virus. I thank all those involved in those efforts, including ministerial colleagues and noble Lords. I note the reference by the noble Baroness, Lady Thornton, to my noble friend Lady Warsi’s optimistic update in this area.
I turn to the point the noble Baroness’s amendment makes about requiring social media platforms to remove and demonetise anti-vaccination content. My noble friend Lady Cumberlege’s points on this are extremely valid. The Government have already secured commitments from platforms such as Facebook, Twitter and Google to the principle that no company should profit from or promote anti-vaccine misinformation and disinformation, and to respond to that content much more swiftly. We are holding platforms to these commitments and have set a series of policy forums in motion, bringing together platforms, academia and civil society organisations to better develop responses to online misinformation and disinformation. These forums are chaired by my ministerial colleagues in DCMS, to whom I give thanks. I attend them and can report back that they have a constructive and thorough approach.
I understand the concern that noble Lords have about anti-vaccination content and the harm it causes. I stress that the Government are totally committed to working with the platforms and other key stakeholders to combat that content and to build public trust in our vaccination programme. I point noble Lords to the continued high rates of Covid-19 vaccine uptake that we see, which have been achieved in part by our effective approach to tackling vaccine misinformation and disinformation. We are not complacent; we are on the case. Therefore, for that reason, I hope that the noble Baroness, Lady Thornton, sees the Government’s efforts in this area and feels able to withdraw her amendment.
I thank the Minister for that comprehensive answer. I particularly thank what I can describe only as a bouquet of Baronesses—the noble Baronesses, Lady Altmann, Lady Bennett, Lady Masham and Lady Cumberlege—for their support. I say to the noble Baroness, Lady Cumberlege, fear not: if I had intended to have a Division on this I would have given her pre-warning, do not worry. I also thank my noble friend Lord Hunt for his pertinent questions and the noble Lord, Lord Naseby, for his four action points, which were instructive and useful.
This has been a useful debate that has been worth having, because we have so few opportunities to knock around issues that we all agree on and really want to support the Government to get right. That is why I tabled the amendment. I am very happy with the response to it and I beg leave to withdraw the amendment.
(3 years, 10 months ago)
Lords ChamberThe 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.
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.
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.
(3 years, 10 months ago)
Lords ChamberI 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.
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?
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.
(3 years, 10 months ago)
Lords ChamberThe 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.
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.
(3 years, 10 months ago)
Lords ChamberMy 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
(3 years, 10 months ago)
Lords ChamberMy 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.
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?
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.
(3 years, 10 months ago)
Lords ChamberMy Lords, I can give my noble friend no such assurance. The decrease in sugar in soft drinks, as he knows full well, between 2015 and 2019, was 43.7%, and the increase in soft drink sales during that time was 14.9%. With six out of 10 adults and more than one in three children between the ages of 10 and 11 technically obese, clearly more needs to be done.
My Lords, I think that the noble Baroness, Lady Boycott, is quite correct, and I did appreciate the Minister’s last answer to his noble colleague. But perhaps the Government need to consider healthy food where they can actually influence this, such as in hospitals, schools and care homes, and reinstate standards for healthy foods in those places.
Yes, I entirely agree with the noble Baroness. There are parts of the Government’s estate where more could and should be done in order to promote healthy foods. I pay tribute to the work of Prue Leith, who has done a lot to champion healthy food in hospitals. Progress has been made; I visited Southampton hospital with her earlier last year and saw her bringing healthy food direct to the patients, and the use of trolleys in order to ensure that warm food is delivered and that food does not have to come out of a plastic bag. More can be done, but I reassure the noble Baroness that we are working hard at it.
(3 years, 11 months ago)
Lords ChamberThe noble Lord makes his point extremely delicately and politely, but he is entirely right. We have a commitment for five extra healthy years by 2035, and the combination of the Marmot review, the ONS figures and Covid make that seem an extremely daunting challenge indeed. I am not sure if I have the complete answer standing at the Dispatch Box right now. I would be glad to write to him and explain how we will undertake the Green Paper on prevention, the response to which will be published next year, as an opportunity to outline the kind of strategy he calls for.
The Minister’s response to my noble friend Lord Davies of Brixton was an abrupt one, which kind of suggested that it was an accident that we are where we are with life expectancy and that the Government’s policies have no impact on that. My question actually follows very neatly from that of the noble Lord, Lord Patel. Do the Government intend to establish life expectancy and well-being as a strategic marker and measure for the whole nation’s well-being and welfare in all Acts? How will that feed into reforms for the NHS?
My Lords, I think that healthy living and life expectancy is a strategic marker. We are naturally focused on it and, in particular, the disparities between communities, which have been alluded to by a number of noble Lords. The huge gap between life expectancy in Blackpool and west London is extremely disturbing, and something that the Government are highly focused on. These are complex issues. They involve government policy—as the noble Baroness quite rightly points out—but also personal behaviours, and it will very much form part of the NHS plan going forward and the rebooting of the NHS in a post-Covid world.
(3 years, 11 months ago)
Lords ChamberI hear the concerns of both the noble Lord and his mother very clearly but I assure him that, to date, the rollout has very much focused on the 70 hospital hubs where we are getting the protocols and practices about getting this extremely difficult vaccine into people’s arms correct before we roll out distribution to all GP services. It is not at all my expectation that every GP service in the country will have the vaccine, nor that they will necessarily be ready to deliver it this week, but that guidance has been distributed. If the noble Lord would like to send me the details, I will ensure that that GP practice is up to speed on this important matter.
My Lords, my concern is about NHS staff. They may need to deal with a third wave in the new year, they will be required to work through the Christmas period dealing with the current spike and they will be co-ordinating the vaccine—so they might be completely overstretched in January and February. Would it be a good idea to ensure that at least front-line, high-risk clinical area staff are vaccinated immediately? Does he agree that this would make sense from an operational point of view? I know from my work as a non-executive director of a London hospital that it would be a huge morale booster for the staff to whom we owe so much.
I take on board the noble Baroness’s points on the NHS. Its staff have been under huge pressure, which is likely to be sustained into the new year. I pay tribute to their hard work. The JCVI has looked extremely carefully at the prioritisation. The most important thing is to avoid pressure on ICUs and the threat of mortality. That has been done by prioritising age over role. I also pay tribute to the St John Ambulance service, which has done an amazing amount of work in gathering 40,000 inquiries for training on delivering the vaccine. By undergoing training, those people will relieve NHS staff of an enormous amount of the pressure that the noble Baroness rightly describes.
(3 years, 11 months ago)
Lords ChamberMy Lords, I thank the Minister for the update today, and for the all-Peer Zoom this morning. Yesterday was indeed a happy day. Like many—including, it has to be said, the Secretary of State—I was very moved watching 90 year-old Margaret Keenan get her jab. However, the challenges of the next period are as acute as, if different from, those of the period we have been through. What is the timeline for the vaccine for people who are housebound or shielded and cannot attend a surgery, whether in a hospital or anywhere else? It seems that the easy distribution of the vaccine will depend on the new vaccines coming down the track: communications will be vital. So what communications will people receive, from whom? Will that be centrally controlled or will it be done locally—through primary care networks, for example?
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.
(3 years, 11 months ago)
Lords ChamberMy Lords, the noble Lord makes a completely fair point. There is absolutely no question of there being a social stigma associated with taking PrEP or any kind of moral cloud over those wishing to take this important therapy. That is not in any way our purpose. He makes a valid point that there are good arguments for the supply of PrEP to be not just through GUM units but also through GPs and perhaps pharmacists. These are arguments that we hear and that we are looking at very closely. I hope that, at some point, I will be able to update the noble Lord on our progress on this matter.
I remind the Minister, with regard to his last answer about funding, that just because you cannot solve all the world’s problems does not mean that you should not try to solve some of them. On that basis, can the Government provide an update on the rollout of PrEP in England? Is the Minister aware that there are local authorities that are still not providing the drug? When the ring-fenced funding for PrEP runs out in March 2021, will the Government commit to at least the £16 million per annum to make this happen for the future?
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.
(3 years, 12 months ago)
Lords ChamberI am extremely grateful to the noble Baroness for suggesting the New York precedent. It is not one that I was aware of and I will look into it. I reassure her that we are liaising with all our international partners over the vaccine rollout to ensure that we put in the best possible practice that we can.
My Lords, I have read the JCVI priority list. As the Minister has indicated, some granularity is going to be vital. There is so far no mention of vulnerable BAME communities, who have borne the disproportionate burden of the pandemic. How will the Government approach those vulnerabilities in setting the priorities and their implementation?
My Lords, the underlying principles of the advice of the JCVI are to reduce mortality, to improve population health by reducing serious disease and to protect the NHS and the social care system. The basic insight is that the risk of serious disease and death from Covid increases exponentially with age and increases in those with a number of underlying health conditions. Those are the basic principles of the interim advice and they will evolve over time.
(4 years ago)
Grand CommitteeMy Lords, I will be very brief, as it must be clear to the Minister that there is unanimity across the Committee in support of setting up this safer care task force. My noble friend Lord Hunt was quite right that this is about whether the Government take this report seriously, and for me this is also an issue of accountability. Recommendation 9 of nine states:
“The Government should immediately set up a task force to implement this Review’s recommendations.”
I hope that the Minister will just say, “Yes, we’ve done it”, so that we can now be told what the timeline for the task force will be and who will be involved. That is my hope from the Minister’s remarks, but if that is not to be the case, I hope that it might be the case in two or three weeks’ time when we move to the next stage of the Bill.
My Lords, again, I thank my noble friend and her team for their work to produce the report and to ensure that patients and their families have been heard. Above all, I pay tribute to all the patients and their families who have so bravely shared their experiences to inform this important report. The report has been impactful and has already served to firmly put patient safety at the top of the agenda for all the healthcare system, and we in the Government are committed to learning from it.
On the amendment, if I may put this delicately, we must please remember that this is not a Bill to respond to the review. The Bill provides the powers needed to be able to update the current regulatory regime for medicines, devices and clinical trials in response to the end of the transition period, although the Bill does have the best interests of patients at its heart.
If it was not for the ongoing impact of Covid-19 on the health and care system, I believe that we would be discussing little else but patient safety. But, as my noble friend Lady Cumberlege has acknowledged in this Grand Committee, Covid has had a challenging impact on all our priorities, including on her own work on the NHS maternity transformation programme —and, of course, on the publication of her report, which was scheduled for the beginning of this year but, because of Covid, happened only 16 weeks ago.
I can assure noble Lords that much activity is already under way. Officials from across the healthcare system have been working together intensely since the report’s publication. They have been meeting weekly since August to ensure that we fully understand the report’s recommendations and the best way forward.
My noble friend has rightly mentioned the importance of listening to and involving patients in the implementation process. We absolutely recognise the need for effective patient engagement to ensure that we get implementation right. The Minister of State, Nadine Dorries, will provide an update on this and other matters related to the report in December, and I shall be very happy to report likewise to this House.
These debates have been clear, and I can assure noble Lords that, as part of our consideration of the report, we will of course want to be informed by the debates on this Bill before responding in detail to this very important report. I am very sympathetic to the desire of my noble friend and others to see the Government move quickly in responding to her report, but I do not agree that this Bill is a sensible method of delivery for that response. It is a weighty report, and our response will be rightly scrutinised when the Government responds to Parliament, but an amendment in this Bill is not the right mechanism. We should not be making policy through legislation, for that rarely makes for good government policy-making.
Therefore, I hope that this is a probing amendment, seeking some reassurance, rather than a firm request. In that spirit, I welcome the opportunity to update the Grand Committee on some of the progress that we are making to date.
Recommendation 1 has been implemented. The Government have, on behalf of the health and care sector, apologised to those women, their children and their families for the time that the system took to listen and respond.
We debated my noble friend Lady Cumberlege’s amendment for a patient safety commissioner just a few days ago, so I shall not repeat all the points raised. It was an insightful discussion, and I will think on it further, as I said during the debate.
We shall shortly be debating Amendments 122 and 123, on establishing a redress agency and redress schemes, so I will not pre-empt those discussions.
On recommendation 5, I know that my noble friend is already aware of work to establish specialist centres for mesh removal, but I would like to say a little more in recognition of its importance. NHS England is working closely with providers to set up the specialist mesh removal centres and is currently working to prepare for launch next April. The service specification for mesh centres describes how all centres must come together in a clinical summit to agree how we can develop the service moving forward, to agree standards that all centres will work to and to share data and outcomes. The first summit will take place tomorrow, 20 November. I am pleased to note that clinicians from the devolved nations are invited to that session too.
On recommendation 6, the MHRA has already begun a substantial programme of work to change the culture of the agency. Key priority areas are: first, listening and responding to patients; secondly, better utilising scientific evidence to strengthen and speed up decision-making on safety; and, thirdly, becoming more open and transparent in everything that the agency does. The MHRA is strengthening its yellow card scheme to make it easier for both patients and healthcare professionals.
On recommendation 7, as my noble friend will also be aware, we have debated Clause 16 of the Bill. Significantly, its provisions will mean that, in future, we can collect surgical implants and devices data from all NHS and private provider organisations, starting with mesh-related procedures and from that agreed next steps.
On recommendation 8, the General Medical Council already has guidance covering financial and commercial arrangements and conflicts of interest, which came into effect on 22 April 2013. In addition, the GMC’s updated consent guidance came into effect on 9 November. This reaffirms that any conflicts of interest that a doctor or their organisation may have should be shared with patients where relevant. We are considering whether these arrangements should be strengthened further.
My noble friend Lord O’Shaughnessy spoke of a worrying attitude of fatalism in the system, but I should also flag the work being done by GPs, universities and the royal colleges on long Covid and the excellent work being done to protect patients. We are listening to patients, who are presenting highly complex symptoms, including mental health, renal, cardiac, respiratory and other issues. I host a weekly round table that has full engagement with representative groups. We have mobilised a whole-system response. We are linking research with guideline writing for primary care in real time. We are using data thoughtfully, and we are mobilising networks of concerned groups around the country and around the world. This reflects the priority that we have already put on the recommendations of the patient safety report.
My noble friend Lady Cumberlege and her team took two and a half years to complete their review and present their findings, and I am intensely grateful for that. It is imperative, for the sake of patients and especially those who have suffered greatly, that we give this independent report the full consideration it deserves. I look forward to updating the House following the Minister’s Statement in the other place before recess. I therefore hope that my noble friend Lady Cumberlege feels able to withdraw her amendment.
I think this has been one of those really rather good and unexpectedly deep House of Lords discussions, going back into the mists of time. Until the noble Baroness, Lady Cumberlege, mentioned the redress Act, I had completely forgotten about it—it all came flooding back.
We have two quite different amendments in this group, and my noble friend Lord Hunt said at the outset that his Amendment 122 was a probing amendment. This is about opening up the discussion, which it certainly did—a discussion that has long needed resolving. The noble Lords, Lord Lansley and Lord O’Shaughnessy, were quite right in that it is an issue of the future; this group has one probing amendment about the future—what it should look like and how you create an agency that can address the issue of those harmed by medicines and medical devices. It is a very legitimate discussion, which needs to be had.
The second amendment, in the name of the noble Baroness, Lady Cumberlege, is about the future, what happens now and what happens about the harms that were done—the avoidable harms, in the case of hormone pregnancy tests, sodium valproate and pelvic mesh. That is very important indeed, and the noble Baroness is right to say that those harms must be specifically addressed by the Government and to push that. I think that is what we would be looking for—how the Government would implement those recommendations. I see the noble Baroness, and the noble Baroness, Lady Bennett, whose comments we very much welcomed and valued, but I do not think that was the last word. I hope she will involve herself in the next stage of the Bill. In fact, I am depending on it.
The Government have to address Amendment 123 in particular, because that is urgent and needs to be done now. I look forward to hearing what the Minister has to say about that in particular.
My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Bennett of Manor Castle—who indicated her interest in this along with my noble friend Lady Cumberlege—for raising the important issue of redress for those harmed by medicines and medical devices.
I share the review’s concern that patient voices were not heard, and I reiterate that we are committed to ensuring that the healthcare system does better at listening, learning and acting on patient concerns. Furthermore, we recognise that patients need to be at the centre of decision-making to ensure that their perspectives are built in.
Our focus is on improving the safety of medicines and medical devices so that in future there should be less need for redress. We are determined to increase patient safety and drive additional pre-market scrutiny and post-market surveillance of medical devices. For example, the yellow card scheme plays a vital role in providing an early warning that the safety of a product may require further investigation, and the MHRA is transforming and strengthening the system to make it easier for patients and healthcare professionals in the UK to directly report adverse incidents involving all medicines and medical devices. The UK has one of the safest medicines systems in the world and we will continue to make sure that patients and the public have access to the best and most innovative medicines.
Amendment 122, in the name of the noble Lord, Lord Hunt, would require the Secretary of State to bring forward proposals to establish a redress agency within 12 months of the Royal Assent of this Bill. Committing now to such an agency would short-cut the in-depth policy consideration that the review’s recommendation of a redress agency deserves, as a number of noble Lords have reasonably recognised. I understand that my noble friend Lady Cumberlege herself undertook substantial engagement with the affected patients and other parties as part of her review. Listening and consultation is a vital part of how we take forward any policy change, and it is even more important given the significance of this issue.
A redress agency would represent a significant addition to the current landscape for all stakeholders, and we need to give them time to contribute their perspectives and think through the implications for them. In particular, there is a need to work through what the determinations and parameters of such arrangements would be and how they would interface with current legal remedies—already complex—before we could agree to take forward this proposal. This would help us explore how that would affect the patient journey through different potential approaches, the costs and their value for money. We also need to be mindful of the potential impact on industry.
With regard to Amendment 123, tabled by my noble friend Lady Cumberlege, given that legal action is pending over hormone pregnancy tests, and as is usual when matters are sub judice, I am restricted in what I can say on this aspect of the amendment.
I know that the establishment of a specific redress scheme was my noble friend’s fourth recommendation in the report of the Independent Medicines and Medical Devices Safety Review. While I am very sympathetic to the desire of my noble friend and others to see the Government respond to her report and take forward her recommendations, I do not agree that policy should be made and deadlines set through primary legislation. Indeed, her report itself was sadly delayed during the current situation we find ourselves in.
I reassure the noble Lord, Lord Hunt, that we will respond to the issues raised in the amendment as part of our formal response to the Independent Medicines and Medical Devices Safety Review. The Government are considering all recommendations made in that review and will provide an update before the Christmas Recess. I hope that the noble Lord, Lord Hunt, has heard enough that is reassuring and feels able to withdraw Amendment 122, and that my noble friend Lady Cumberlege is similarly reassured not to move hers.
The only question I want to ask is the question the noble Lord, Lord Sharkey, has just asked. Can the Minister give a rational explanation about why certain parts of the Bill come into force at different times? The key question on commencement is whether the commencement schedule as drafted risks holding up any of the work that needs to be done or allows the Government to move too slowly on anything.
My colleagues in the Commons drew attention to this provision as essentially a means of saying, “at some point in the future”. Can the Minister give an indication of the timeframe in which the Government expect to get these regimes consulted on, regulated for and up and running? As the Bill is drafted, the timing is left rather open-ended.
My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which would require the Secretary of State to act in accordance with the guidance on the use of civil sanctions—I am sorry, I am on the wrong amendment.
Amendment 145, in the name of the noble Lord, Lord Sharkey, seeks to amend the commencement clause, Clause 44, so that all provisions would come into force on the day the Bill receives Royal Assent. I am confident that the amendment is not necessary. Clause 44(1) provides that the clauses needed to make emergency amending regulations will come into force the day the Bill receives Royal Assent.
Under Clause 44(2), a significant number of clauses come into force after the customary two-month commencement period. Chapters 3 and 4 of Part 3 come into force on a day the Secretary of State appoints which is specified in regulations. This combination of commencement provisions is for a good reason. Patients, stakeholders and Parliament must know what the law is before the law is made. The two-month commencement period allows the Government to continue to engage with industry and the relevant stakeholders properly before provisions come into force.
Importantly, Clause 44 provides for the necessary powers and provisions to come into force on Royal Assent should it be necessary, within that two-month period, to make regulations urgently in order to protect the public from an imminent risk of serious harm to health.
I understand that there may be concern about Clause 44(3), which allows the Secretary of State to determine when Chapters 3 and 4 of Part 3 come into force, but I assure the noble Lord that, again, this is for a good reason. Chapter 3 of Part 3 is concerned with enforcement and included in that is the introduction of a civil sanctions regime. Civil sanctions will act as a flexible, proportionate enforcement mechanism, enhancing the MHRA’s ability to incentivise compliance. The new civil sanctions regime requires supplementary regulations to be made under paragraph 9 of Schedule 1 before it can be fully operational. It is important that the MHRA engages with industry and stakeholders on these regulations and the accompanying guidance. Indeed, the Bill requires a consultation to be carried out before they are made. If these provisions came into force on the day the Bill achieved Royal Assent, we would have no time to make the necessary regulations. Our time to consult in advance on those regulations and the guidance would be severely condensed.
It is absolutely right that we consider the views of stakeholders and the public before making the supplementary regulations and bringing the new civil sanctions regime into force. I assure noble Lords that the Government are committed to bringing the enforcement and data and disclosure chapters into force as soon as is appropriate in order to enhance the safety of the medical devices regime. I hope the noble Lord, Lord Sharkey, understands the reasoning behind the clause and feels able to withdraw his amendment.
(4 years ago)
Lords ChamberMy Lords, I am not sure that that is what the National Audit Office has said. It has, very reasonably, alighted on the importance of transparency and the declaration of interests, values that any reasonable Minister or public servant would subscribe to. The Cabinet Office itself has played a very energetic role during the entire pandemic, providing the systems, support and people, including contract staff, to make sure those values are upheld.
May I just say to the noble Lord, Lord Robathan, that we supported the Government having the emergency powers to allow them to act quickly but it is also important, even if people are giving their services for free, that they are held properly accountable.
It is rare to be able to return to a question that one feels was unanswered the day before. I asked the Minister if George Pascoe-Watson, the chair of the lobbying company Portland Communications, had signed a confidentiality agreement upon his appointment as a ministerial adviser. I would be grateful if the Minister could specifically answer that question: did George Pascoe-Watson sign a confidentiality agreement when he was appointed? Presumably, that is on the public record. Would the Minister also inform the House if he or any of his officials have had any contact, by any means of communication, with Mr Pascoe-Watson or anyone else at Portland Communications since the Sunday Times published its story online on Saturday evening?
My Lords, the very large number of advisers, both paid and unpaid, were all processed by the department and their paperwork was then handed on to the Cabinet Office for approval. George Pascoe-Watson, as others, was sent both a declaration of interest form, which he filled in and is on record, and a volunteer agreement, which has the Official Secrets Act built into it. His work was covered by that.
(4 years ago)
Lords ChamberTo ask Her Majesty’s Government what recruitment policy is used by the Department of Health and Social Care in the appointment of unpaid advisers to Ministers; and whether each such appointee is required to sign a confidentiality agreement.
My Lords, I welcome the challenge. Perhaps I may reassure the noble Baroness that all ministerial appointments were required to declare conflicts of interest and abide by well-established codes of practice, and that all procurement went through proper departmental governance. Perhaps I may also be clear that those who stepped forward to help this country at its time of need should be praised. We should all recognise the considerable contribution of those who brought skills, energy and networks when we needed them.
My Lords, I do not see this Question as a challenge at all. It would appear that George Pascoe-Watson, the chair of the lobbying company, Portland Communications, was until recently an adviser to the Minister and used the words,
“the decision makers have told me personally”,
with regard to the Government’s intended Covid restrictions, in an email to his clients before the proposed restrictions have been publicly announced. In some places, this kind of thing could be regarded as insider trading—profiting from private information for one’s own or a company’s gain. Does the Minister believe that the rules of confidentiality have been broken? Will he be pursuing the matter? It clearly should be investigated. What form will the investigation take? Will it be departmental, or is it a matter for the Cabinet Office or the head of the Civil Service?
My Lords, I am extremely grateful to the noble Baroness for giving me the opportunity to set the record straight. It is worth sharing with the House that the emails to which she referred were sent after George Pascoe-Watson left his role as an adviser to the department. With the greatest respect to Portland and its chairman, the emails contained nothing more than the kind of speculation that one might find in any national newspaper. Therefore, at this stage, I thank those who have served as advisers to me and the department.
(4 years ago)
Grand CommitteeMy 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.
My Lords, we had an excellent debate last week on the subject of medical device information systems at Clause 16, which is critical for how we will go forward on these points. The noble Baroness, Lady Finlay, seeks in Amendment 95 to confirm that the Government will make regulations to establish the system, not that they might. We will introduce this system; the noble Baroness provides no timescale attached to the obligation she introduces. It is essential that the regulations are informed by consultation. The discretion that “may” provides allows for this consultation to be conducted. We want the regulations to be right, not rushed.
I spoke last week on Amendment 96, in the name of the noble Baroness, Lady Thornton. Devices have varying levels of risk profile; it is our intention in the first instance to use the power in Clause 16 to require all implanted devices to be recorded in information systems. Implanted devices pose the greatest risk to patients and it is right that these should be prioritised. Consultation will help us to determine which devices ought to be captured by the information system.
On Amendment 99 in the name of the noble Baroness, Lady Finlay, we recognise the importance of all the issues in Clause 16(2): that is why they were explicitly referred to. However, there may be occasions where the inclusion of provisions in regulations on all four of the issues listed here is not appropriate or necessary. For example, in future we might wish to update the types of information in Clause 16(2)(a) to include, perhaps, a new way of recording a procedure or a device. We might have no immediate need for further provision under 16(2)(b) to 16(2)(d). Without the flexibility afforded by the current drafting, we would be prevented from making proportionate regulation limited to what was necessary.
On Amendment 100 in the name of the noble Baroness, Lady Finlay, the drafting of Clause 16(2) is sufficiently broad as to say, “among other things”. Regulation is not limited to the four suggested areas for provision at subsection (2)(a) to (d).
The noble Baroness suggests mandating recording of information on any medical device implanted into the human body and the information related to any other medical device as considered necessary for patient safety. Clause 16(2)(a) is sufficient for both these matters. While they are clearly important, the addition is unnecessary.
The noble Baroness adds a requirement of patient consent for the information to be recorded in the information system. I hope that the assurances that I provided to my noble friend Lady Cumberlege last week gave her some comfort on this point. I am happy to write further on this, but the noble Baroness will know that the information systems are conditional on regulations, on which we must consult.
The noble Baroness adds in her amendment expert oversight of any information system established under Clause 16(1). I do not think this is necessary. The information system acts as a database. Where expert oversight is needed is in the assessment of patient outcomes, where information is reviewed by clinical registries operated by experts in their field.
I understand the intent behind Amendment 101. I pay tribute to the noble Baroness, Lady Masham, and my noble friend Lady McIntosh, who put it very well. The patient voice is very important in the assessment of the efficacy and safety of medical devices, but I do not wish to confuse the purpose of the information system. It is a hub; it is not a decision-making tool. There are existing routes to raise specific concerns and experience of devices.
The yellow card scheme allows patients to complete and submit reports themselves. This gives a single, clear route for patients to avoid confusion about who to tell and how, and to ensure that all necessary parties receive all data relating to patient concerns. However, data used for analysis needs to be consistent in format and terminology to ensure that comparisons can be drawn and to maximise the ability to spot common themes and issues.
Amendment 101A in the name of the noble Baroness, Lady Finlay, is unnecessary. Even though the overarching objective of the information system is medical device safety, and therefore a reserved matter, I have made it clear that I am committed to ensuring early and ongoing consultation and engagement with colleagues in Scotland, Wales and Northern Ireland as we look to develop a UK-wide system. I say for the record that it is of great importance to us all that we work together to improve the safe use of medical devices across the four nations. I strongly agree that there is a need for a centralised approach to address the existing gaps in the traceability of medical devices placed on the market. The Government have already introduced Amendment 126 to Clause 41. Therefore, it is neither necessary nor appropriate to set out the engagement or working arrangements between the four nations in regulations.
I understand that the aim of Amendment 104 in the name of my noble friend Lord Lansley is to ensure that organisations protect any information that could identify a patient, such as their name and their records. I reassure him and others who have spoken to the amendment that this information is used and shared only when it is appropriate to do so.
On the Caldicott principles and guardians, I am sure that these matters will be brought forward by others in consultation. That is the forum for addressing these points. Adherence to the Caldicott principles is expected of all NHS organisations, including—some would say most of all—NHS Digital. The Caldicott principles have been developed into the national data guardian principles that apply in England. GDPR also requires that personal information be treated in this way. All data collected by the information system will be subject to GDPR. The intention is that the medical device information system should hold patient-identifiable information. Information that is de-identified will be shared with the relevant organisations to ensure the protection of that patient. It is unlikely that there would be any requirement to share patient-identifiable information with other organisations. MDIS would be programmed to know, when provided with notices by MHRA or others, that action needed to be taken and which patients it applied to.
Parliament oversees data protection legislation. The standards are very high, and we have no intention of lowering them. I do not think, therefore, that having regard to the Caldicott principles is necessary or would add anything material to the legal constraints that would apply to this information. Of course, we have no intention of doing anything contrary to those principles through this legislation. Regulations under Clause 16 will be subject to public consultation. Under GDPR, they are also subject to the requirement to consult the Information Commissioner’s Office. We have already begun discussions with the Information Commissioner’s Office on this basis.
I am grateful to the Minister for that detailed answer, but as far as I can see, it underlined the point about the fragmentation of patient safety. He is undoubtedly right about the need to change culture. Will the Minister look at this again, because I mentioned the three inquiries in the past 20 years that I knew about very well, and every one of them said very similar things to what the Minister has said? None of them has produced the kind of support that one would want for patients or been the catalyst required here from the patient safety commissioner. Will the Minister go back and think about this again?
I take the encouragement of the noble Baroness to heart. I would be very happy to think further on it. She makes a very good point: we know about the terrible incidents of the past and the very substantial responses that they had. I share with her the frustration that these problems continue to arise. For that reason, as I said, we are looking for a really thoughtful, considered response to the review overall. As I said in my earlier remarks, the case for a patient safety commissioner is one that we are looking at. I listened to absolutely everyone who has spoken in its advocacy, but we do not regard it as a silver bullet or a single point of catalysis, which I do not think the noble Baroness was alluding to. We are looking for a broad response to the review that would ultimately take on all the different points that the noble Baroness and her review team have made.
(4 years ago)
Lords ChamberThe noble Lord is entirely right that we have to approach the prospect of a vaccine in a measured way. There remain considerable imponderables about the effectiveness, longevity, impact and side-effects of a vaccine. These are things that we do not know yet, and we have to keep our eyes open to the limits of what the vaccine may or may not be able to do. That said, the initial data from Pfizer is incredibly encouraging. We have taken a measured approach in our communications to date. Jonathan Van-Tam, the Deputy Chief Medical Officer, is the face of the vaccine, as it were; he is the member of the Vaccine Taskforce who has brought the clinical perspective to its work, and he will remain an important voice in all this.
It is good news indeed. I would like the Minister to share how the Government are preparing to build public confidence in the vaccine and counter the anti-vax campaigns. Following my noble friend’s question earlier, I would be grateful if the Minister could share with the House the plans for reaching harder-to-reach communities, so they can get the information they need and access to the vaccine when the rollout starts.
The noble Baroness is right that we face a challenge. While there will be millions of people who will come forward emphatically to have the vaccine, there will be some who are either disengaged with the British Government or actively hostile to the thought of a vaccine, and we take seriously the disruption caused by those who seek to profit either financially or politically from the confusion and distress caused by anti-vax campaigns. It is not appropriate for me to discuss at the Dispatch Box the detailed measures we are putting in place to deal with the anti-vax message, but I can reassure the noble Baroness that they are focused, energetic and proving to be effective.
We also take seriously our efforts to reach hard-to-reach communities—those who might not have confidence in the Government or we might not have the right connection with. Those communities are exactly the ones we need to vaccinate, and we are making them an enormous priority in our efforts.
(4 years ago)
Grand CommitteeMy Lords, I have greatly appreciated this debate, the expertise, and the explanations we have been given as to why the amendments are important. I particularly enjoyed the remarks by the noble Lord, Lord Ribeiro, about his hips: very important they are indeed.
Perhaps we should remind ourselves that Clause 16 was inserted in the Bill during the Commons stages after a cross-party effort involving the Labour Front Bench working with the Government. It provides for a data system to be set up by regulations to assist in tracking devices once they are implanted, so that safety performance and clinical effectiveness can be better monitored. The intention is that in the long term, that would support future device registries, allowing problems to be spotted earlier and patient harm to be prevented.
The amendments would tighten up that clause. The amendments tabled by the noble Baroness, Lady Finlay, are concerned with the operation of the tracker, using the devices’ unique identification. Currently, Clause 16 provides that unique device identifiers “may” be recorded as part of the data system. Quite rightly, the amendment would change that “may” to a “must”. So much of our work revolves around changing “may” to “must”.
Amendments 86 and 88 would amend Clause 13. Amendment 86 would require that UDIs should be considered as part of the packaging information on medical devices, and Amendment 88 would require that tracking devices used in individual procedures should be part of the Government’s consideration when regulating device registries. These amendments raise questions about the detail of device tracking. How will the unique identifiers be recorded and used? Those questions were raised by both the noble Baronesses, Lady Finlay and Lady Cumberlege. Will it be mandatory to record the unique device identifier in every procedure, and feed that into the data system? How can we ensure that that data is secure, and that it is recorded in the appropriate place? The Minister has those questions to answer at the end of the debate.
The noble Baroness, Lady Cumberlege, rightly addressed the issue of patient consent. She also underlined the fact that there is an opportunity in the Bill to get the law and the framework right. Amendment 103 would add to Clause 16 a requirement that the regulations must specify what information held by a data system is subject to a patient’s consent. The intention is that data held under the system should be used and shared to identify trends and trigger regulatory and clinical action where it is needed.
In her report, the noble Baroness cites the difference between a database and a registry. She is right to do so. The amendments explore the importance of the registry and the database, and the importance of patient consent —and whether we return to the subject at a later stage will depend on what the Minister now has to say.
My Lords, I am enormously grateful for that really important discussion of these critical amendments and provisions. I will take a moment to run through them in some detail. Device safety is absolutely critical to patient safety, and that is why the Government amended the Bill to include Clause 16. I pay tribute to my noble friend Lady Cumberlege, whose team helped inspire that amendment, and to the noble Baroness, Lady Finlay, who has participated in discussions on this clause. We have the benefit of her insight now.
Amendment 86 in the name of the noble Baroness, Lady Finlay, would add the unique device identifier number to the provisions in Clause 13(1)(g). These provisions currently allow the Secretary of State to make regulations about package labelling, provision of information and instructions for medical devices. UDIs would be one of the matters included within regulations made in reliance on Clause 13(1)(g), as drafted. It is therefore our belief that the amendment is not necessary.
The noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro made important and fascinating remarks on Scan4Safety. I will limit my comments, which could be extensive, to the importance and value of that scheme. We are extremely supportive of the principle of fast and accurate traceability. Scan4Safety is not the only scheme of its kind, but it is a particularly good one. It is the hope that any UDI created by these regulations will empower these valuable services. We have a session on medical device information systems coming up in the diary, when I hope very much that we can discuss how that might work. If the concern of the noble Baroness is whether we intend to make provision to require manufacturers to provide a UDI, I reassure her that that would be a condition for being placed in the UK market.
Amendment 88 to Clause 13, as the noble Baroness, Lady Finlay, has indicated, is intended to support the tracking of devices used in medical procedures by recording the UDI in a register provided for in Clause 13 or within hospital episode statistics. I completely acknowledge the noble Baroness’s intent, but there is a difference between a register at Clause 13 and a database at Clause 16, or a registry. Clause 13 provides for a register or a number of registers. The register or registers we intend to create under Clause 13 will be a list of medical devices for sale on the UK market, held by the MHRA. It will not include the individual product identifier part of the UDIs and it will not contain data or monitoring information related to individual devices. The register forms part of wider market surveillance and vigilance activity. Regulations will be able to make provision requiring information to be entered into a register, such as the unique device identifier, which all manufacturers will be required to put on their devices. Amendment 88 is therefore unnecessary.
While the registers will enable some device identification to track individual devices, it is the information system, created under regulations made under Clause 16, which will ensure that devices and procedures are tracked in the event of a concern being identified, through which patients can be contacted and appropriate action taken in each case. The use of MDIS, which I will come on to, could prompt the MHRA to use the information in the register established under Clause 13 to identify the manufacturer and take action.
Amendment 102 would add information to be recorded in any information systems established under Clause 16. All the information set out in Amendment 102 can already be required under regulations made under Clause 16, but the regulations do not have to set out all those matters and can set out other descriptions of information.
A UDI may not always be available, such as for a custom-made device, so it may not always be possible for the providers to capture this. Amendment 102 would also require the recording of every procedure that related to a medical device. I have spoken before about the number of different medical devices on the market and that they vary greatly in risk profile. It would not be necessary or cost-effective to record every procedure related to a medical device, but they could be recorded in one of the registers provided for by regulations under Clause 12, as being on the UK market.
Amendment 103 in the name of my noble friend Lady Cumberlege deals with the important issue of patient consent. It would introduce an obligation that regulations made under Clause 16 would require the Secretary of State to set out the categories or types of information that are subject to patient consent that are held by the Health and Social Care Information Centre, otherwise known as NHS Digital, or by other persons.
My noble friend has raised this with me and with officials, and she is a tireless champion of patients. I am moved and affected by the accounts she has heard. As the testimony in her review shows, the absence of data in the healthcare system is absolutely medieval, and it is exactly the purpose of the Bill to fix that. Before any data can be collected relying on the provisions at Clause 16, regulations must be made. Those regulations are subject to consultation, as at Clause 41. It is absolutely right that the system is informed by patient views, and that the process is one where it is easy to engage, to understand what we want to do and to build consensus that it is the right thing.
My noble friend Lady Cumberlege has views on what data should be subject to opt-out versus opt-in. Privacy is a higher-order value that we should protect. The question of patient consent is really important. The noble Baroness, Lady Finlay, campaigned on the importance of opt-out organ donation and I congratulate her on her contribution to the recent change to organ donation privacy protocols, which are widely supported by the public and will save thousands of lives. She knows as well as I do that choosing to opt into measures is not as comprehensive as choosing to opt out. It is important to have enough data to draw conclusions.
Consent will not be required to input information about the surgical procedure and the UDI of the implanted device, linked to the patient, into the information system. The medical device information system is about protecting all patients who have had similar procedures, not just a particular patient. The detail of the specific device inserted, the procedure information and, if necessary, the effect that device has caused is what will be necessary for the information system to work. If there is no adverse report made by the clinician on behalf of that patient, that data acts as a control sample. It allows for other patients’ reports, where there have also been adverse reactions, to be understood as part of a wider data picture.
In her report, my noble friend raised the recommendation that detailed data should require consent in order that the data collected is necessary and proportionate. I reassure her that all data collected for the system will be necessary and proportionate. Data held by clinicians should be shared only under those circumstances, and data shared by the information system with, for example, a clinical registry for clinical assessment of whether there is an issue, should be only that which is necessary.
The intention is, that in the event there is a reported adverse reaction with a device, the medical device information system would send a report to a clinical registry. That report, suitably anonymised and stripped of patient-identifiable information but including the device UDI, would have the detail of all procedures, not just those involving adverse reactions, to further anonymise the incident. A clinical assessment would be conducted and, if it is concluded that the device is the issue, only relevant and necessary information would be sent to the MHRA to conduct its own tests.
This is a very important paragraph and one that I will emphasise. We do not need patient-identifiable information to determine whether compliance or enforcement action needs to be taken, but device information. There are routes to identifying that there are issues with adverse reactions when a clinical registry is not present, such as manufacturers’ reports or Yellow Card reports.
Can the Minister run it by me again how this will protect patients? I heard a lot being said about physicians and their reporting. I am not sure that I understand how this will avoid the problems with valproate and all the other situations with mesh unless “must” is used rather than “may”.
I can give a couple of illustrative examples if that would be helpful, but to run through the whole philosophy and system is probably beyond my ability or the time afforded by this Committee. In essence, the challenge identified by my noble friend Lady Cumberlege is that individual reports of adverse signals are not easily connected, unless those reports are somehow sent to a central registry and analysed by the kinds of experts who can spot mistakes and the connections made between those signals. This is how any problem identification system works. To do that process, you do not have to share personal details. You do not need the telephone numbers or personal identities of those concerned, but you need the clinical details and the full context in which signals have occurred. This pattern identification is often missing in the instances on which my noble friend reported. Having this information system, and analysis connected to it, will enable us to spot problems at a much earlier stage. Necessary interventions based on analysis and understanding will be much prompter and the connections made much more emphatic.
This amendment is interesting and certainly worthy of consideration. The innovative medical devices fund would insert a new subsection into the National Health Service Act 2006. Section 261 provides powers for the Secretary of State in relation to voluntary schemes to control the cost of medicines. The section describes these as schemes that are joined voluntarily and limit the price that may be charged on the profits that may accrue from the manufacture and supply of health service medicines. The scheme also provides for manufacturers and suppliers to pay the Secretary of State an amount of money if the agreed limits are breached. Amendment 91A would create a voluntary scheme under Section 261 which would be specifically for medical devices to give them equal treatment as innovative medicines. The Minister will have to explain why that would not be a good idea.
In her speech at Second Reading, the noble Baroness, Lady Finlay, talked about making the UK a medical devices development and production hub. Too often the UK effort has been bought out by overseas manufacturers who then market the devices back to the NHS at great profit.
My Lords, Amendment 91A seeks to replicate the innovative medicines fund with a comparable fund for medical devices called the innovative medical devices fund. We have had a terrific debate on this. The ideas and insights shared by noble Lords have been extremely powerful, but perhaps I may address the points in turn.
The goal that is shared wholeheartedly by the Government is that we recognise the huge benefits that medical devices can deliver. My noble friend Lord Lansley and the noble Lord, Lord Hunt, put that particularly well. We recognise the astonishing pace of innovation and development that is creating new healthcare options for patients across the UK. In fact, that is one of the reasons we are considering this Bill. We are extremely ambitious and are determined to capitalise on the opportunities presented by new medical technologies to ensure that the best innovations are adopted and spread across the NHS.
Devices, like medicines, are key to ensuring patient health, but they are different and it is not necessarily helpful to use a system that was developed for medicines to be used for devices. For example, the primary purpose of the innovative medicines fund is to cover the cost of managed access agreements where NICE feels that there is insufficient evidence to give a positive opinion and asks for further evidence to be collected before the product is re-evaluated.
Devices are not assessed by NICE in the same way and we do not consider that mirroring the provisions for medicines would necessarily be beneficial. In particular, unlike medicines where, once licensed, they do not change, medical devices are constantly evolving. New iterations of medical devices are developed quickly, their impact on patients changes, often rendering earlier iterations completely obsolete within relatively short periods of time. That gives rise to the potential for funding mandates to be in place for devices that are no longer the best or most cost-effective in their category. Requiring the mandatory purchase of all but the most innovative devices by commissioners would not be a sensible use of NHS funds. We therefore need to find different systems of process to ensure that innovative and effective devices, along with other medical technologies such as digital, find their way to the NHS and to patients.
That is why we have boosted the remit of the Accelerated Access Collaborative. It will bring together leaders from across Government, the NHS, regulators and industry to address the underlying challenges that delay patient access and uptake.
As chairman of the AAC, the noble Lord, Lord Darzi, has been able to bring his world-leading expertise to bear to deliver a host of successes in recent years. Indeed, almost 750,000 patients have benefited from access to AAC-supported innovations in recent years, including more than 315,000 patients who have accessed new technologies supported through the innovative technology payment programme. The AAC is going further to deliver the commitment in the NHS Long Term Plan to accelerate the uptake of proven, affordable innovations with the introduction of a new medtech funding mandate. The mandate will ensure that all patients have faster access to selected cost-saving devices, diagnostics and digital products approved by NICE, via medical technologies guidance and, when available, NICE diagnostic guidance for innovations.
The final criteria to be used in the mandate will be announced in the consultation response to be published in December this year, and the mandate will take effect from April 2021. Additional steps are being taken to ensure that the mandate translates to front-line improvements in patient access. The NHS standard contract has already been updated to state that the relevant parties must comply with their obligations under the mandate guidance, and technologies receiving the mandate will benefit from dedicated support via the regional academic health sciences network to help drive local adoption and spread.
NICE also recognises the need to ensure its methods for assessing innovative medical technologies continue to support our ambition for the NHS to provide world-leading care that delivers value to patients and the NHS. The NICE methods review is therefore under way, with extensive input from industry and patient representative groups. The consultation on the case for change to existing NICE methodology is open until 18 December, and I encourage all those interested to submit their views.
Finally, it is also important to note that in her amendment the noble Baroness, Lady Finlay, stated that moneys should be paid to the Secretary of State under Section 261(9) of the National Health Service Act 2006 in order to support an innovative medical devices fund scheme. However, Section 261 of the National Health Service Act relates only to voluntary schemes agreed with pharmaceutical manufacturers which control the prices charged, or profits accrued, by manufacturers and suppliers of health service medicines. The vast majority of medical devices would not therefore be within the scope of such a scheme.
I trust that I have been able to reassure the noble Baroness that the funding of medical device technology in the NHS in England is of great importance to the Government and that we are actively putting in place mechanisms to support it. On this basis, I hope very much that the noble Baroness, Lady Finlay, will feel able to withdraw her amendment.
(4 years ago)
Lords ChamberIn my view, the Government have offered little support to dentist practices: not exempting them from business rates, even though book- makers and vape shops are exempted, and not offering them key worker status, which has caused problems with childcare. Can the Minister commit to early access to Covid-19 vaccines for all high-street dentists who are NHS contractors, rather than employees? Can the Minister give them key worker status?
My Lords, one area where the Government have made a big commitment to dentists is in PPE. As of Wednesday 4 November, over 5,000 dental and orthodontic providers in England had registered with the PPE portal and over 36 million items of PPE had been delivered. In terms of the commitment to workers, I will have to come back to the noble Baroness.
(4 years ago)
Lords ChamberMy Lords, I think it is to be welcomed that the response to the Urgent Question last week was that travelling for the purposes of an assisted death would be exempt from lockdown travel restrictions. However, there are concerns that this Statement did not go into detail about whether family members could accompany people. Legal constraints mean that it is not clear whether the exemption applies to them. Presumably, they would have to demonstrate their reasons for travel and might, in the course of doing so, incriminate themselves for assisting a suicide. So can the Minister clarify that family members accompanying someone travelling for an assisted death will not be vulnerable in this way? If the Minister does not know the answer in detail to this important question, please would he seek to find out from the Ministry of Justice, write to me, and put the letter in the Library?
The noble Baroness is entirely right on the question of travelling abroad for the purpose of assisted dying. It would be regarded as a reasonable excuse, and therefore anyone who did would not be breaking the law. In answer to the noble Baroness’s question, under Section 2(1) of the Suicide Act 1961, a person does commit an offence if he or she
“does an act capable of encouraging or assisting the suicide or attempted suicide of another person”
and that act
“was intended to encourage or assist suicide or an attempt at suicide.”
The 1961 Act provides no exceptions to the prohibition on assisting suicide. The maximum penalty, as noble Lords may know, is 14 years, and there is nothing in the Coronavirus Act or any recent legislation that in any way changes that.
(4 years ago)
Lords ChamberOn the manner in which the information was delivered, I take the noble Baroness’s comments completely on board. While it is not my role to be in charge of the presentation of No. 10 presentations, I think a lot of people would agree with her that there were a lot of slides, which were very detailed and not all formatted for the TV screen. However, we are trying our hardest to share with the public as much of the insight and science as we possibly can, and we are trying to hit that balance between too little and too much information. We are trying to publish data as soon as it can be reasonably verified. There will be some scratchiness around the edges on that, and I take the noble Baroness’s points about last Saturday completely on board. However, the commitment to transparency and open debate on these issues is sincere.
When will the Government start sharing data and having meaningful discussions before decisions are taken? Given that public confidence in these decisions is crucial for them to work, will the Government start working with the opposition parties, which they expect to—and which have—supported the lockdowns and proposals, as Keir Starmer and others have been offering for months?
The noble Baroness is right to pinpoint the sharing of data as being very important, and we have been as open and transparent as we can be. We publish an enormous amount of data. Just before this debate, I tweeted three of the main portals to the data, which there is not only an unprecedented quantity of but which is more up to date than could reasonably have been expected a few months ago, when such data was not available. Some of these decisions are made extremely quickly because the data changes so quickly. Sometimes, one believes that we are on track for one thing, and then the virus changes course and we have to change our policies accordingly. That is simply a fact of the challenge of fighting this virus: speed is of the essence, and sometimes it has been extremely difficult to do the kinds of consultation that the noble Baroness quite reasonably describes.
(4 years ago)
Lords ChamberMy Lords, it seems to me that, however urgent the requirement for PPE and other services, transparency becomes even more important in those circumstances. The Minister will be fully aware that the Ministerial Code says that Ministers are responsible for ensuring that no conflict exists, or appears to exist, between their personal interests and their public duty. As the former chair of a procurement committee for MyCCG, I received extensive NHS training on conflicts of interest, which are defined as
“a set of circumstances by which a reasonable person would consider that an individual’s ability to apply judgement or act, in the context of delivering, commissioning, or assuring taxpayer funded health and care services is, or could be, impaired or influenced by another interest they hold.”
Perception is as important as reality. Has the noble Lord declared the interests that arise out of the meetings that other noble Lords have mentioned today? Where are they recorded and published?
The noble Baroness is right that transparency is key. I take those principles extremely seriously, and that is why we are publishing the contracts. I encourage anyone who is interested in looking at them to look at my Twitter feed, where I published a link to the Contracts Finder service yesterday. I reassure her that, although some connections were made through networks, absolutely every contract had exactly the same technical assurance, exactly the same contract negotiation and exactly the same procurement scrutiny. Those were done by civil servants, and value for money for the taxpayer and the people was guaranteed by that process.
(4 years ago)
Grand CommitteeMy Lords, I understand that the intention of Amendment 30, in the name of the noble Baroness, Lady Thornton, is to prevent the use of data for any purpose other than preventing the supply of falsified human medicines. The noble Baroness raises an important question. Let me reassure her that we have thought very carefully about these powers. There is an important precedent already for using the data held in the current EU Falsified Medicines Directive “safety features” system for wider purposes. For instance, as well as using the data to investigate instances of falsified medicines, data on the EU system can be used for the purposes of reimbursement, pharmacovigilance and pharmacoepidemiology. The effect of this amendment would be a step backwards on what any potential falsified medicines scheme introduced under Clause 3 could deliver.
We know from implementation of the EU system that the checks involved could generate a rich source of data, and that there may be circumstances where we would want to be able to use that data to support the safe and effective use of medicines. For example, information in a future falsified medicines scheme could be useful in the event of a product recall to help quickly identify individually affected packs. I recognise that information about the supply of medicines through the supply chain can be commercially sensitive—the noble Baroness, Lady Jolly, made this point very well. That is why Clause 3 ensures that, in making regulations under this power, the appropriate authority must ensure that information is retained securely. Information will be subject to strict controls set out in regulations, including what purposes the data could be used for, who would have access to or use it, and under what conditions.
I turn to the noble Baroness’s second amendment in this group, Amendment 33. While I understand the desire of the noble Baroness, Lady Thornton, to ensure that we have robust requirements around the safeguarding of information, this amendment would cause difficulty for the appropriate authority making regulations under the provision in Clause 3. This is because it would require action to secure retention of data even where the regulations themselves may not concern data—for example, provisions related to who may set up the infrastructure.
Amendments 31 and 32, in the name of the noble Lord, Lord Clement-Jones, would operate together to place an obligation on the Secretary of State to seek to agree and lay a framework on the use of information collected for the purpose of preventing the supply of falsified medicines. This would be done within six months of the Act coming into force.
We can all agree with the noble Lord, Lord Hunt, and others that close collaboration through consultation with stakeholders, including with pharmacists, is essential to getting something like this right, not least given the importance of data security. However, Amendments 31 and 32 would not create the right mechanism for providing this. I can reassure the noble Lord that we have planned fulsome engagement and consultation with a wide range of stakeholders. This can be achieved without this additional obligation, but I would be glad to commit to an engagement session with noble Lords and officials if noble Lords would find this helpful.
The Government have committed to exploring all options in regard to a falsified medicines scheme to ensure that patients continue to be protected from the public health threat posed by falsified medicines. As part of this, we will explore with stakeholders what information needs to be collected as part of any national scheme. Only once we have established how any scheme could work can we fully consider how the information that it collects could be used to deliver the most benefits for the UK and for patients. However, this amendment would force us to consult on an agreed framework outlining the use of information within six months of Royal Assent, without necessarily having the full picture of how a national scheme could work.
We also want to explore creative uses of information as long as they are for public interest purposes. Therefore, we do not want to constrain or limit options ahead of engagement with stakeholders.
I should make it very clear that the overarching principles of the Bill as set out in Clause 1 also apply to our powers here. The scope of the purposes mentioned is not unfettered. The appropriate authority must be satisfied that regulations dealing with anything under Clause 3—not just around how the information will be used—will promote the health and safety of the public. In making that assessment, the appropriate authority is required to have regard to the three considerations discussed previously in Committee.
I remind noble Lords that Amendment 126 in my name ensures that this will be a public consultation, while Amendment 131, also in my name, places an obligation on the Secretary of State to review regulatory changes made under Clause 1(1). The consultation will consider how the information collected as part of the scheme could be used, and any regulations providing for the use of information would be subject to parliamentary scrutiny under the affirmative procedure. In light of these reassurances, I hope that the noble Baroness, Lady Thornton, will feel able to withdraw her amendment and the noble Lord, Lord Clement-Jones, will be content not to press his.
I thank the Minister for his detailed response. I just have to wonder why the consultation did not take place before the Bill was drafted. You have to ask why stakeholders were not involved in the discussions prior to this happening and why they then felt the need to get in touch with those of us involved in this Committee to express their concerns. So I have to say to the Minister that I will certainly be discussing with stakeholders their reaction to what the Minister has said and whether that allays their frustrations and anxieties.
The process that the Minister described, which I shall read in detail and think carefully about, looked circular. It looked like a process that involves consultation, powers in the Bill that we have already questioned, and the affirmative procedure. All those things may not be satisfactory, so we will probably need to return to discuss this at a later stage of the Bill—or, preferably, before. I beg leave to withdraw the amendment.
My Lords, I will not add much more, as I am very interested to hear what the Minister has to say. The noble Lord, Lord Patel, has done the Committee a great service by tabling the amendment and asking this question. I was not aware that there was an issue here, which there clearly might be, and I will be interested to hear the answer. If this is an area that is covered by European Union regulation, and we are therefore creating a new regulatory framework for children’s data in clinical trials, it is important that we know that and how it might happen. I am very interested to hear what the Minister has to say.
My Lords, in response to the point of the noble Baroness, Lady Thornton, the noble Lord, Lord Patel, is right: paediatric trials are very important, and they have sometimes been overlooked. However, that does not detract from the fact that the UK has a strong international reputation for paediatric medicine research. The MHRA authorised 177 new clinical trials that included children in 2019—more than any other country in the EU. The Bill, in Clauses 4(1)(d) and (e), already enables us to make regulations about requirements to be met before the clinical trial may be carried out and on the conduct of the clinical trial. That can provide for a number of different options, including paediatric clinical trials. I reassure the noble Lord that the Human Medicines Regulations 2012 will include provisions equivalent to those of the EU paediatric regulations when amendments come into force at the end of this year. These include requirements for the review and approval of paediatric investigation plans. These plans are aimed at ensuring that the necessary data is obtained through studies in children.
I recognise that the EU regulations played an important role in promoting the development of paediatric medicines, so that children are not forgotten when adult needs drive drug innovation. I am happy to commit to write to the noble Baroness, Lady Jolly, on her questions about EU statistics on that matter.
I understand that there is currently ongoing evaluation of the EU paediatric regulations and that this may bring about changes to the legislative landscape. This Bill will allow us to adapt the UK regulations based on patient needs and to keep pace with any changes in any other jurisdiction, including the EU. It gives us the opportunity to go even further to enhance the UK system and to encourage UK paediatric trials.
It is critical that the UK paediatric regulatory framework remains flexible, to adapt to emerging paediatric research challenges, and supports UK innovation, while also supporting global development plans. I reassure noble Lords that the MHRA has already published guidance on a new UK approach to paediatric investigation plans. This is part of the GOV.UK transition period guidance for businesses and citizens. The UK will simplify the PIP application process for applicants conducting paediatric research by offering an expedited assessment where possible and by mirroring the submission format and terminology of the EU PIP system. This approach ensures that the UK can continue to provide incentives and rewards to support innovation in paediatric drug development and to encourage manufacturers to bring medicines to the UK market.
The MHRA will aim to continue to participate in paediatric scientific discussion among the global regulators at an early stage and during the conduct of clinical trials. This will facilitate the exchanging of emerging information during the studies to minimise the exposure of children to medicines that do not work or are unsafe, and we will aim to maintain a national position of influence, so that the final paediatric development aligns with, and supports, global regulators’ requirements.
I hope that the noble Lord, Lord Patel, has had sufficient reassurance that the amendment is unnecessary and feels able to withdraw Amendment 40.
(4 years ago)
Lords ChamberI assure the noble and learned Baroness that we understand absolutely the contribution of hospices, the value for money that they represent, the role that they play in communities and the incredible sensitivity with which they handle end-of-life and palliative care. I pay tribute to the contribution made by the noble and learned Baroness to the Living Well Dying Well charity and to Hospiscare. It is the contribution of people such as the noble and learned Baroness to the hospice care movement that has made it such a powerful and sensitive supporter of people at their time of most urgent need.
It will be quite clear to the Minister now that virtually every single Member of your Lordships’ House has a local hospice to which they are attached. Mine is St John’s Hospice in St John’s Wood, which has just launched an appeal to recoup a £1.3 million shortfall during the pandemic. Because hospices are being asked to take on more and more patients that they do not have the funding to cover, I hope that the important 4 November meeting will be based on an assessment of the need for continuing support for the sector for the remainder of 2020 and into 2021. Also, what plans do the Government have to ensure that everyone who needs quality palliative and end-of-life care will continue to receive it through and beyond the pandemic?
The noble Baroness will know through her work as a lay member of the NHS Camden Clinical Commissioning Group that hospices are much valued by the healthcare system. I assure her that the agenda for 4 November will include an assessment of the ongoing support that hospices will need through the winter.
(4 years ago)
Grand CommitteeThe Committee owes the noble Baroness, Lady Sheehan, a debt of gratitude for bringing forward this amendment. I very much enjoyed her opening speech—and, indeed, those of the noble Lords, Lord Alton and Lord Crisp, both of whom are so well qualified to speak about international health responsibilities.
What this debate does is to remind us of how privileged we are to live in a country with free access to new medicines and innovations. However, we are now entering choppier international waters. We have been sheltered, as it were, over 40-odd years or so by the European Union’s heft and regulatory framework. So we need to take notice of the need for greater co-operation, as has been outlined by the noble Lord, Lord Patel.
I was very struck by the mention of things like price gouging by the noble Baroness, Lady Sheehan, and their dangers for those less fortunate than ourselves. On the immediate responsibilities and dangers around the Covid vaccination, which we so desperately need, the World Health Organization says that it is working on a plan to ensure equitable distribution of vaccines, but how that would be enforced in practice is not clear. Professor Mariana Mazzucato, who heads the University College London’s Institute for Innovation and Public Purpose, says:
“In a pandemic, the last thing we want is for vaccines to be exclusively accessed by countries that make them and not be universally available.”
That is absolutely right.
However, as the noble Lord, Lord Crisp, said, we need to pay attention to what is happening in the UK and what the effect of Brexit might be—and, goodness me, we are all on tenterhooks as to whether we get a deal or not. Rick Greville, the director with responsibility for supply chain at the Association of the British Pharmaceutical Industry said, in the run-up to a no-deal Brexit—the last time this happened—that there could be currency fluctuations, including a fall in the value of the pound. He said:
“You can imagine in that situation that exporting medicines into Europe would become even more profitable. It may be that”
drugs
“that currently aren’t being exported suddenly become attractive to export, driven entirely by profit”.
The UK is not invulnerable to what might happen next, and I would like the Minister’s observations on that.
Launched earlier this year, COVAX wants wealthy nations to pool funds that together can be used to develop and scale up vaccine production. In return, rich countries would have a guaranteed supply for about 10% and 15% of their population. I would also like the Minister’s answer to that, because several noble Lords have raised that question.
This is one of those debates in which one feels that so many people are better qualified to speak than oneself. I finish by quoting the noble Lord, Lord Crisp, and what he said on Monday. He said:
“This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.”—[Official Report, 26/10/2020; col. GC 71.]
I could not have put it better myself.
My Lords, there can be absolutely no doubt about the importance of patient access to medicines. This is very much at the heart of the NHS constitution, and it is absolutely fundamental to how we regulate human medicines.
I completely agree with the noble Baroness, Lady Thornton, that the noble Baroness, Lady Sheehan, has done us a great service with an incredibly impressive speech, which was thoughtful and powerful and a privilege to listen to on Monday. The speeches of the noble Lords, Lord Alton and Lord Crisp, who I do not think is present, drew on many years and huge experience of international affairs and comparisons. We are very grateful for the challenge that those speeches have given us on this extremely important subject. But I reassure all speakers to this amendment that this Bill will absolutely not change the importance of patient access to medicines and how we regulate that.
This has been a wholly positive and helpful debate, and I hope that it will lead to improving the Bill and the future of this issue. I shall speak briefly to the amendment in my name and that of the noble Baroness, Lady Watkins. It would allow the Secretary of State to make regulations about notification and reporting requirements for medical device clinical investigations, as is currently the case for medicines. It is about the equality of treatment between medicines and medical devices, so it is very straightforward.
I thank my noble friend Lord Hunt, who I suspect made a double speech, his own and that of the noble Baroness, Lady Finlay, and it is all to the good that he did. I again register the protest that we are losing experts and speakers because of the clash of timetabling.
All the amendments in this group are positive amendments about how medicines and medical devices reach the market, how the UK can build and maintain a leading position, and the regulatory framework required to support that. Amendment 97, in the names of the noble Lords, Lord Kakkar and Lord Patel, does that, and I thought that the noble Lord, Lord Kakkar, made some very interesting points about how it might best be achieved. The noble Lord, Lord O’Shaughnessy, and the noble Baroness, Lady Cumberlege, were quite right about putting patient safety at the heart of this and having higher levels of evaluation—the term used by the noble Lord, Lord Kakkar. The noble Lord, Lord Patel, got straight to the heart of the issue, which is that we need to get together to work out how best to take this issue forward at the next stage of the Bill. I look forward to what I hope will be a positive response from the Minister and then to the Government taking some action.
My Lords, I start by endorsing the comments of the noble Baroness, Lady Thornton, and saying that I am extremely grateful for this debate, both the spirit in which it is being conducted and the objective of trying to improve the legislation. I think it will make a big difference to the legislation.
The issue of the safety of medical devices and medicines is, of course, critical. We have been greatly moved by the report of my noble friend Lady Cumberlege, who spoke earlier to this group of amendments. It is an extensive and important report, which highlights the impact on patients when they have not been heard, when they report problems or concerns with a medicine or a medical device. It is particularly focused on pelvic mesh but could have addressed other subjects. The Government will address its detailed recommendations when the time is right.
I understand that safety is the driving concern behind Amendments 26 and 90, tabled by the noble Baroness, Lady Finlay. She offers up an alternative way in which to regulate medicines and medical devices, with the creation of a rapid, provisional two-year licence. Medicines and medical devices are regulated very differently between the two of them. That is in part because we have anticipated regulatory change for medical devices at an EU level for some years, and it is in part down to the practical realities of how they are developed.
I shall touch on the process and distinction. However, what I would say is that, intent aside, the amendments of the noble Baroness, Lady Finlay, are not necessary. Amendment 26 would introduce a rapid two-year provisional licence for medicines. The Bill as drafted already provides the necessary powers under Clauses 1 and 2(1)(d) to make changes relating to marketing authorisations. It is similarly already possible to introduce a rapid, provisional two-year licencing process as she suggests in Amendment 90 at Clause 13(1)(b) of the Bill.
By tabling parallel amendments with the same suggestion of a two-year, rapid provisional licence for medicines and medical devices, the noble Baroness suggests, perhaps, paralleling similar requirements of a pre-market assessment. The noble Lord, Lord Kakkar, suggests using the information system in the government amendment in Clause 16 in combination with a limited marketing authorisation system as a way of assessing devices before licencing them, as in his Amendment 97. We believe that Clause 13(1)(b) is sufficiently flexible to deliver the purpose of his explanatory statement. We believe that it is not needed as an amendment to Clause 16.
However, this debate is not, I think, about what the Bill could provide for; it is about what the Government will actually do. For human medicines, we have made changes in the statutory instrument that sets out the situation on 1 January. That update provides for a national “conditional marketing authorisation”, valid for one year. It can be renewed annually. It is a procedure to expedite the assessment of medicines that fulfil an unmet medical need but, importantly, maintain the robust evaluation of supporting evidence. It is less than the five years an ordinary marketing authorisation is granted for, but none the less we believe it serves the purpose. I hope the existence of that process is what the noble Baroness is driving at.
(4 years ago)
Lords ChamberMy Lords, I take my hat off to the London School of Hygiene & Tropical Medicine, which runs an extremely exciting trial. In fact, the Secretary of State is visiting this very afternoon in order to get an update on that trial. Dogs can be used as a way of screening crowds in such places as airports and high-density venues. The validation of that method has not been proven yet, but I am personally extremely hopeful and remain grateful to those involved in the pilot.
We move from dogs to the technical teething problems with the app. It seems that the NHS Test and Trace app sends out exposure warnings to people stating that they have to isolate and then a few hours later sends another alert saying that there is no issue and they do not have to isolate. That probably means it is working quite well, but it does not tell anybody where they might have been exposed, or, as I have experienced, it flashes at you that you have been near someone who has tested positive and then there is complete silence. When will we be able to trust the technology to help us as well as alarm us? Secondly, when will the care homes testing speed up? Care homes’ turnaround time for tests still seems to be stuck in three to five days on average.
My Lords, on the app, the noble Baroness alludes to two separate issues. The first is the exposure notices, which are not sent by the NHS app but by the Apple telephone device. We have put in the new version of the NHS app a way of mitigating those exposure notices. She is entirely right that the app has no idea of your geography; that is the genius of the app and its commitment to privacy. It means that we cannot tell you where you were exposed, but also that your location and privacy are protected. On social care, we are investing in a large number of trials to try to speed up mass social care testing, including bulk testing and the use of wastewater, which we discussed earlier.
(4 years ago)
Grand CommitteeI thank all the speakers who supported our Amendment 20 and the amendments that follow on from it. I need to start by placing on the record that we do not agree with the Government’s amendments to this clause but we will not object to them. Were we not in the situation of basically having to agree to put these amendments in the Bill, this is a very good example of where we would need to have a different kind of debate. Looking specifically at the Government’s amendments, I think that adding the word “favourable” does not clarify the meaning or elucidate anything. Since we are not absolutely certain what “attractiveness” means, I am not sure we can be clear what “favourable” means either.
Our amendments, and others that noble Lords have tabled, would take the first stab at defining “attractiveness”. I am very attracted to the amendments that the noble Lord, Lord Sharkey, spoke to, because the idea of improvement is also very important. We are in the same territory and we will need to put further thought into this between now and the next stage of the Bill.
My noble friend Lord Hunt was completely correct when he spoke about the need to address how slow we are in this country in the uptake of new medicines and innovations. The noble Lord, Lord Patel, said that if we do not define “attractiveness” we might end up with the sort of undesirable trade-offs we discussed earlier today.
We have had a very interesting and useful discussion—the kind of discussion we should have in Grand Committee—where various points of view come together. We can see that we might end up with a completely new amendment at the next stage that will define “attractiveness” in the Bill and talk about the need for improvement and innovation. We will probably need to put our heads together between now and then.
My Lords, this has been an important discussion as to what attractiveness of the UK means. We have already moved on this issue with our amendments. We are still listening. I thank noble Lords for an instructive and wise discussion of this issue.
The noble Lord, Lord Sharkey, offers a definition in Amendment 15 that would include manufacturing. My noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, suggest adding “medical innovation”. In Amendment 20, the noble Baroness, Lady Thornton, and others set out a number of additional aspects, such as
“favourability to the establishment of research, design or manufacture of medicinal products or related services”
I reassure all those noble Lords that it is our instinct that the consideration of “attractiveness” as written in the Bill is sufficiently broad. It contains multitudes. While processes such as the clinical investigation of devices are not specifically listed as a consideration in Clause 12, they are covered in the current wording. Manufacturing is of course a vital element of the supply chain. Any impact on manufacturing will be relevant when considering the attractiveness of the UK as a place to supply medicines.
I acknowledge that the term “attractiveness”, as noble Lords have remarked in conversation, is not ordinarily found in legislation. However, I believe it is largely one of common sense. We all wish to protect the ways in which the UK is attractive. In 2015, the ABPI estimated the value of the life sciences sector to be £30.4 billion. Some 482,000 jobs were supported by the sector. We wish to protect that and to be a place for both innovators and generic manufacturers.
That is why this test is essential. It is a reminder, but it does not need to be comprehensive in the legislation. It needs simply to rule in, not rule out. That is why manufacturing is not explicitly mentioned, nor the other factors, although it is covered. Were we to list all the various aspects of how medicines and devices are made, we might miss something. We might interpret this list as prescriptive, rather than illustrative, and not cover an equally important but novel aspect of the future.
I hope that the government amendments provide further clarity. While noble Lords have drawn attention to specific aspects of how the UK is attractive, which are very important, their amendments are unnecessary. However, if there are particular considerations that the noble Lords, Lord Hunt and Lord Patel, and the noble Baroness, Lady Thornton, have concerns about—I note words such as “procurement”, “scale up”, “adoption”, “take-up of innovation” and “data-driven technologies”—I ask them to write to me. If further reassurances can be provided on why we consider this to be the right construction, I will be happy to respond.
In this instance, I hope the noble Lord, Lord Sharkey, is therefore willing not to move Amendment 15, and that other noble Lords do not feel compelled to move their amendments.
(4 years, 1 month ago)
Lords ChamberMy Lords, the situation raised by Cancer Research UK and others causes concern, but I reassure the noble Lord that we are doing more than a million routine cancer appointments and operations per week to catch up with the backlog. Urgent two-week waits for GP referrals are back to almost 85% of pre-epidemic levels and we have a massive plan to address this, which includes the creation of Covid-secure environments, switching to new drugs for those who cannot make it to hospital, the judicious use of radiography, targeted messaging to those who may suffer from the symptoms of cancer, the use of rapid health diagnostics, an alliance with charities, a cancer recovery plan and enhanced monitoring on a single version of truth basis of our progress on this important issue.
My Lords, I would like to follow up on the Question of the noble Lord, Lord Rennard, which was about investment. The UK spends on average half as much on capital in healthcare compared with similar countries, so the average number of MRI and CT scanners is well below the OECD average per million of population. Does the Minister agree that to tackle the cancer backlog and improve survival outcomes the Government must also implement the recommendations of Sir Mike Richards’s recent review into diagnostics and significantly invest in the necessary diagnostic equipment?
The noble Baroness is right to raise the excellent report by Professor Sir Mike Richards into cancer diagnostics. We have taken that report on board and are studying it very carefully; it will inspire us tremendously. As I mentioned earlier, £153 million has been allocated to cancer alliances. The investment in capital is an extremely important part of that. I want to flag a few immediate developments: diagnostic capability at the Harrogate and Exeter Nightingale hospitals, the community diagnostic hubs and the rapid diagnostic centres are all in focus for this investment.
(4 years, 1 month ago)
Lords ChamberI am grateful to the noble Baroness for her insight, but I reassure her that the information on the app is not covered by this memorandum of understanding. That is a principle that has been made very clear by the NHS app. This is the data held on CTAS, the Public Health England database, and it remains the property of Public Health England; the MoU is very specific about that. As the noble Baroness is aware, the app is a distributed source of information; it has extremely high privacy barriers, and this MoU does not in any way breach those barriers.
It is disingenuous for the Minister to say, in answer to my noble friend Lord Hunt, that this is not a health issue. Following on from the question of the noble Baroness, Lady Lane-Fox, I imagine the police will have been concerned about the implications for data protection for both themselves and individuals. Therefore, I ask the Minister how personal data that is being handed over to the police is going to be stored. Who will keep it and how will it be handled? Are any discussions on data-sharing taking place or planned involving the Department of Health and Social Care, and the Home Office or Cabinet Office?
My Lords, the data collected by PHE for the test and trace service is held, as I said, by the Contract Tracing and Advisory Service database—the CTAS database—and it will be provided to the police on request. It is not a question of a wholesale sharing of all data. The data that can be shared with the police are the recorded name and contact details of an individual who has been instructed to self-isolate, the date on which they were told to self-isolate and the date on which the period of self-isolation ends. No testing data or health data are shared with the police at all.
(4 years, 1 month ago)
Grand CommitteeMy Lords, I hear the noble Lord, Lord Patel, very clearly. The arguments that he made during our conversations and engagement earlier were powerful. The comments made by my noble friends Lord Lansley and Lord O’Shaughnessy, one of whom is my predecessor and one of whom is a former Health Secretary, were also extremely persuasive.
The Government do not think that putting consolidation in the Bill is wise, but we hear the points made by the noble Lord, Lord Patel, loud and clear. We would definitely consider this matter at a future date if the arguments made were persuasive and agreeable.
My Lords, I thank all noble Lords who took part in this preliminary and important debate on the Bill.
The noble Lord, Lord Patel, made an important point concerning primary legislation after three years. The Minister seemed to suggest that three years is not long enough. That cannot be right; three years is certainly long enough. Without the principles and policy that my noble friend Lord Hunt spoke about, rule by regulation is not only inadequate but probably quite dangerous. That lies at the heart of this group of amendments.
The noble Lord, Lord Kakkar, made the important point that we have a well-designed regulatory framework in the UK; this amendment is not about disrupting that. He also said that the Bill should be about improving the framework; that is exactly right.
Like the noble Lord, Lord Sharkey, I shall have a minor moan. It is normal practice to give fellow Peers sight of government amendments at least on the day are put down, so even though the Bill team had not managed to discuss their intention with Opposition parties and other noble Lords involved in Committee, we received the letter from the Minister explaining the amendments on Thursday. I hope the Minister and the Bill team will not continue to leave things so late. I remind the Minister that he has a whole Bill team and a department at his disposal. Other noble Lords write their own speeches, do their own research and need more time to give amendments due consideration. I am fortunate to have some excellent support and we work very hard on our side to get our amendments down as early as possible to give other noble Lords the opportunity to consider them and discuss them with us. The Government should always bear in mind the unequal nature of resourcing in this place.
We need to see these amendments for what they are. Of course, they are mostly worthy and we welcome the improvement, but essentially, to echo the words of the noble Lord, Lord Patel, they are there to placate and circumvent. We are late in the day in beginning to understand the nature of these amendments and we now understand the urgency of them as a result of our earlier discussions, for which I thank the Minister and his team. We are waiting for reassurance from the Minister about what happens at the next stage.
The noble Lord, Lord Lansley, made some very important and pertinent points, particularly about the difference between the objective test and the subjective test. It is clever and very important. He is on the side of objectivity and the Government’s amendments are definitely on the side of subjectivity. I agree with him that Amendment 2 is not as good as his Amendment 5. The noble and learned Lord, Lord Woolf, also said something very pertinent and quite correct about not giving blank cheques. He accepts what the Government are offering, but made the point that further discussions are needed and an amendment might be needed as we move forward.
I say to the noble Lord, Lord O’Shaughnessy, that I do not have a principled objection to government amendments coming forward; it is just that we need to know the context for them. The noble Lords, Lord Lansley and Lord Kakkar, and others, including the noble Baroness, Lady Jolly, made a very important point about safeguarding public health, and I hope the Minister will be able to address it. I can probably feel an amendment coming on on that one.
My Lords, I am enormously grateful to my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, for Amendments 5 and 70. I greatly appreciate their scrutiny and contribution on the way in which regulations under the Bill might be made. I am grateful to my noble friend for his constructive dialogue with my officials. His experience and expertise in making legislation on health matters is a real benefit to all of us.
My noble friend and the noble and learned Lord, Lord Woolf, have drawn on the framework of legislation in the EU context. I am grateful for their explanatory statement on the basis of the amendment. My noble friend knows that I pressed very hard to see whether this is something we could accept. The challenge your Lordships have set me is why, if this framework exists in EU legislation, is it too constricting for the Bill? The answer is that examples of significant recent EU legislation in relation to human medicines, clinical trials and medical devices include: directive 2001/83/EC, regulation 726/2004, regulation 536/2014, and regulation 2017/745. In other words, while citing the aim of safeguarding public health in Article 168, on public health, of the Treaty on the Functioning of the European Union, these pieces of legislation were also made in reliance upon Article 114 of the treaty, being measures for the approximation of laws which have as their objective the establishment and functioning of the internal market. To make that point again, safeguarding public health is not the only objective of the EU legislation in relation to medicinal products and medical devices. That is why we have a challenge in this area and why we have posited our amendment.
I shall say something about the other government amendments, specifically replying to the noble Lords, Lord Hunt and Lord Sharkey, and other noble Lords who commented on them. The overall timing of the Bill means that currently, it cannot reach Report any earlier than mid-November. If we start the consent process with Northern Ireland then, it will add a minimum of two months past the end of the Bill’s timeline. To explain to the noble Lord, Lord Sharkey, we need to start the consent process now in order to make further changes. The Government need to demonstrate that this is a policy they wish to make in order for Northern Ireland to get that process properly under way. We have written to Northern Ireland seeking consent to make changes. Parts 1 and 2 of the Bill are transferred to Northern Ireland. I sought consent from Northern Ireland on the Bill as a whole when the Bill was introduced, and again after the change made on Report to Clause 16.
We sought to make government amendments at the earliest opportunity to respond to the DPRRC, partly to demonstrate how significantly we take that report and partly to start this process. That process has now started, but it has not concluded. It does not preclude noble Lords from further consideration and, as my noble friend Lord Lansley, indicated, the Bill has moved. The process of consent is unavoidably three months long in order for the Northern Ireland Assembly to conduct its work. That is why we have had to start now. In reply to the noble Lord, Lord Hunt, I can supplement the legislative consent Motion at a later date.
I will listen. I understand and acknowledge that the noble Baroness sees this as the beginning, not the end, and I acknowledge that she will return to the issue on Report. Accepting these amendments today does not prevent her doing so, and I will continue to listen.
I completely hear what the noble Lord, Lord Hunt, says about engagement with the MHRA. I would be glad to arrange a suitable engagement with June Raine from the MHRA and parliamentarians to discuss these points.
To the noble Lord, Lord Patel, I confirm that the efficacy of a medical device is assessed as part of the process of obtaining a CE certificate. The therapeutic value of a device is not part of the CE certificate assessment; that is a function carried out by NICE. On the point made by the noble Baroness, Lady Barker, on the food chain, I would be glad to arrange a follow-up discussion on the veterinary medicines directorate with the relevant Defra Minister. To the noble Baroness, Lady Jolly, Defra and BEIS are content with this amendment. To the noble Baroness, Lady Walmsley, the medical devices section of the overarching bit at the beginning of the Bill is a carry-on from the sentencing enforcement, and in Part 3 enforcement is in relation to medical devices only. I do not think these are reasons to rewrite the purpose.
I obviously hope to win the argument on some of this, but that will come from extensive engagement and thorough communication going forward, for which I thank noble Lords. I therefore hope that the noble Baroness feels able to accept these reassurances, and I am grateful that my noble friend considers this sufficient reassurance not to move his amendments.
My Lords, I will be happy to write to the noble Lord with the precise figures for phase 3 trials. However, he is right that they are incredibly important. The Bill must defend our position on phase 3 trials, which are very much the sharp end of the clinical trials process.
The learning from RECOVERY is that it is not a direct read-across to rare diseases. The noble Lord is right that in rare disease trials, we are often trying to drill down into very small communities, whereas 113,000 signed up for RECOVERY, and tens of thousands took some of the drugs that went through the trial process. However, it is the general capability of being able to run significant platforms, manage ethics at speed, get regulatory sign-off for these trials, and have a clinical trials regime which suits many different purposes. That is our objective, that is why we are putting through these reforms, and that is why we believe that the Bill can support a modernisation of our clinical trials regime.
On the European trials process, the noble Lord is entirely right that the portal contributes to speedy processes. However, it is not the only way of having a speedy sign-off of trials through Europe; we believe there are other ways of doing that.
Responding to the very last thing that the Minister said, he will have to tell us what those other ways are during the course of this discussion.
This has been a well-informed debate, as I assumed it would be. I think I was right in saying that this issue is at the heart of the Bill and how we move forward. My noble friend Lord Hunt—I thank him for his support —was quite right that this is the big issue. As the noble Lord, Lord Sharkey, said, this is the start of the discussion that we are going to have about attractiveness and where that lies and how it can express itself.
The noble Lord, Lord Lansley, put his finger on various important issues to do with clinical trials. He asked the key question, which I do not think the Minister answered. It is: if we diverge, what will that mean and how will it happen? I did not hear an answer to that question. The answer will determine what some of us do next as we move forward with this Bill. The noble Lord, Lord Kakkar, was completely correct when he said that it is vital that we get this right for the future of life sciences in the UK.
I am grateful to the noble Lord, Lord Patel, for his support for our amendments. He reminded us that we had this discussion during the passage of the main Brexit legislation, when we were told that it was not the appropriate place to such a discussion so the amendment was withdrawn. Now, at the last minute, this must be the place where we have these discussions and come to some conclusion on them.
The noble Lord, Lord O’Shaughnessy, is right. As we strike out on our own as a country, we will need new relationships and we will need to take advantage of what is on offer in the rest of the world. The transition will be very important because what happens in the meantime is vital. We will also need to ensure patient safety in this laissez-faire world, as the noble Lord explained, for example, if we decide to ignore the portal and strike out without it.
I do not doubt for a moment the Minister’s emphatic commitment to making this a success, but as we move forward, this Committee will need to understand much more than what the Minister has told us so far on the risks and opportunities. My final request to the Minister is that we will need a cross-party meeting of some depth—possibly more than one—to discuss this matter with his Bill team and the MHRA. We had such a meeting. It feels as if it was aeons ago, but I think that it was in February, perhaps March. Anyway, it was before we went into lockdown. We absolutely will need meetings and discussions before we move on to the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.
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Lords ChamberI thank the Minister for his explanation of this SI and indeed of the others. I compliment him, as other noble Lords have been doing, on—I do not know what the word is; “sturdiness” is not quite right—his resilience under fire, apart from anything else.
In many ways, this might be the most important SI before us today because it concerns the whole of the rest of the country, which is subject to restrictions that we are all very familiar with and know about. The success of combating the virus will depend in part on those restrictions being adhered to by the rest of the country, so that communities do not move into the next tier. As the Minister said, coronavirus cases are increasing at a terrifying rate.
I want to ask particularly about London. While it seemed that lockdowns were happening mostly in the north, it now seems that London might be heading towards one. Indeed the mayor, Sadiq Khan, has been pressing the Government to put in tougher restrictions in the capital for some time, such as a ban on households mixing. I echo what other noble Lords, including my noble friend Lady Andrews, have said: why are the Government hesitating?
All London’s 32 boroughs have been placed on the Government’s official watch list, which highlights that they are areas of concern, but some are more concerning than others. Eight London boroughs are above the infection rate threshold of 100 per 100,000. Ealing is 136.9; Richmond is 133.3; Redbridge is 124.5. Some of those rates are higher than those for boroughs and cities that are already included in the second tier. This is an important issue because London has very diverse communities and some very poor ones. One of London’s great strengths and, in these days of Covid, vulnerabilities, is how mixed it is and how large its BAME communities are. We have already lost too many BAME fellow citizens, particularly those who work for the NHS. London has not been spared any of that.
Compared to London, Doncaster has an infection rate of 136.9 per 100,000 and is currently in the high tier. Leicester went into lockdown on 30 June with an infection rate of 135 per 100,000. My honourable friend Jonathan Ashworth has asked why the city of Leicester is in tier 2 with restrictions, yet Charnwood—the constituency of Edward Argar MP—where the infection rate is 150 per 100,00, is not. Why are North East Derbyshire, where the rate is 164, or Barrow, where it is 277, not in that tier? There are questions about why other areas have not been included.
Sadiq Khan says that across our city
“the average over the last 7 days is about 90 per 100,000. All the indicators that I have: hospital admissions, ICU occupancy, the numbers of older people with cases, the prevalence of the disease, the positivity, are all going in the wrong direction. Which means, I’m afraid it’s inevitable over the course of the next few days London will have passed a trigger point”.
Is that correct? When was the Mayor of London invited to a COBRA meeting? Have conversations happened at a senior level with the leading citizen of our capital city, as they should have?
As my noble friend Lady Donaghy said in her pertinent questions, we are very concerned about probity. At some point, there has to be a reckoning of the governance of the contracts that the Government have given during this pandemic. My noble friend Lord Robertson underlined that point, in relation to track and trace. My noble friend Lord Rooker also raised the issue, with his usual tenacity. My noble friend Lady Andrews asked the Minister the key question which has been asked all afternoon. I am not sure that I have heard an answer yet. Why did the Government ignore the advice they were given on 21 September?
On a lighter note, the Minister referred to “the rose garden”. My noble friend Lady Donaghy asks whether he means the rose garden at the White House in Washington or the one that Dominic Cummings occupied in Downing Street?
I thank noble Lords for a detailed and illuminating debate which focused, quite rightly, on the interplay between the local picture and the national one. If these restrictions are about one thing, they are about trying to make focused, local lockdown work, so that we can avoid another great, clunking, national lockdown, which would come at enormous social and economic cost. We have seen some incredibly impactful local lockdowns work in Swindon—it was an intervention there, rather than a lockdown—Luton, Leicester and other cities. We are determined to try to make these work.
Getting them to work, as the noble Baroness, Lady Donaghy, rightly said, totally depends on getting the interplay between national and local government right. I am grateful to her for reminding us that the LGA has welcomed these restrictions and the spirit of partnership between local and national government.
In response to the noble Baroness, Lady Donaghy, yes, we absolutely want to work with and deploy the expertise of local authorities. We also absolutely need to back major restrictions with the money to support those communities—the charities and civic institutions, the businesses that are hard hit and the individuals whose jobs are put at risk or who need to stand down. I reiterate the sentiments of the noble Lord, Lord Dholakia, who said we will end up more united than we have ever been. I would really like to dwell on that positive sentiment.
To reassure the noble Lord, Lord Rooker, environmental health officers have been part of our thinking from the very beginning, and reminding us of that has been central to these debates. We spoke about this in some detail in the debate on the “very high” restrictions so I will not repeat myself, but we have put in a huge quantity of resources. We now have 1,000 tier 1 central tracers and 90 contract tracing partnerships, and we have doubled the number of local protection teams. In answer to the noble Baroness, Lady Jolly, local partnerships are absolutely central to our response to Covid.
In response to the noble Baronesses, Lady Thornton and Lady Andrews, the situation in London is very much on our mind. We are in daily, if not more frequent, contact with Sadiq Khan, who has made his sentiments very clear. The encouraging thing is that with these restrictions, and the other investments we have made over the last months, we very much have a shared platform of data on which we can make joint decisions informed by the latest information—information which in no way existed in February, March and April. Talk of data in those days was wishful thinking rather than practical. With these restrictions we have a structure for applying local lockdowns, and we have a much stronger spirit of partnership between national and local government.
The noble Baroness, Lady Andrews, talked about exit strategies, which is a critical question. We have local Covid plans in place in every local authority, and these plans govern the response of the local authority and create a template for the response to the epidemic. These restrictions give a new poignancy to those plans and a new importance to the exit component. Only by working collaboratively with the communities in those local areas will the kind of behavioural changes and containment strategies that can lead to exit really work.
The noble Lord, Lord Robertson, asked about Scottish interoperability. I completely share his frustration, but it is an aspect of the mobile phone app phenomenon that they tend to interfere with each other. We are working with the Irish, Welsh and Scottish DAs to bring about the kind of interoperable nirvana of which he dreams. We hope to introduce a new version shortly.
I would be very glad to write to the noble Baroness, Lady Uddin, with the protocols for those caring for the vulnerable. Those protocols exist and I would be glad to share with her a link to them.
To answer the noble Lord, Lord Rooker, youth clubs are open. There are extremely detailed guidelines for making them Covid-safe; that is the only way in which young people can mix together in those youth clubs. Again, I would be very glad to share those guidelines with him if that would be helpful.
Towards the noble Lord, Lord Bilimoria, I feel a degree of resentment. I thought that I was the country’s leading evangelist and advocate for mass testing, the power of surveillance and innovative technologies such as LAMP and lateral flows, but it seems that the noble Lord has stolen my crown, because he is absolutely the No. 1 evangelist for them. I applaud wholeheartedly his sentiments on that matter.
I am genuinely touched by the kind comments that people have made about these debates and my contributions to them. They are really important; there is a huge amount of them—nor do I think they will stop any time soon. I am glad that this debate is happening on the day that these SIs have been brought into force, which brings a new relevancy to it. I extend my thanks to my opposite numbers: to the rota of spokespeople on the Lib Dem Bench and to the noble Baroness, Lady Thornton, for her enormous stamina. She has been in lock-step with me all the way, and I am grateful to her both for her insightfulness and for the collaborative way in which she has gone about these debates. I extend my thanks also to the Whip, my noble friend Lady Penn, who has been a huge support and demonstrated massive stamina.
My noble friend Lord Eccles asked about the relevancy of these debates. They are absolutely relevant. There are instances where what has been said in this Chamber has been carried into the decision-making and discussions of policy as it has happened. On masks and face coverings, on the importance of sharing data with local authorities, on issues around shielding and communications to the vulnerable, on the role of local infection control and the directors of public health, on the entire areas of social care and mental health and on the impact of restrictions on the economy, noble Lords have expressed clear, insightful and well-informed views and wisdom, and those views have been shared in the decision-making process. It has been a demonstration of this Chamber at its very best.
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Lords ChamberMy Lords, there is some shared interest with those who drafted the Great Barrington declaration. They quite rightly make observations about the impact of the pandemic on education, and we are providing £1 billion to support those whose education has been hit by Covid. They make observations about support for those who are shielding, and we have written a new letter to 2.2 million people who are undergoing shielding. However, the noble Lord is entirely right: this is Johnny Bananas science, and we will not support it.
My Lords, the Minister and I are in complete agreement about this. The scientific understanding of Covid-19 suggests that having had the virus does not guarantee immunity. In fact, cases of second infections are emerging around the world. Does the Minister agree that, until we have a vaccine, this proposal is both dangerous and uncertain, and begs the question of who decides who needs to lock themselves away, and for how long?
The noble Baroness is entirely right. Not only is the evidence of reinfection mounting—a source of huge disappointment, frankly, but something that we have to realistically face up to—but the evidence of long Covid is also mounting, with nearly one in 10 young people infected with Covid reporting some kind of ongoing illness, and many reporting extremely worrying neurological, cardiac or renal damage. This is not flu; this is not a complex cold; this is not a posh version of a duvet day. This is a very serious infection that leaves a long effect on those who are vulnerable, and even on the young and fit. We should be very wary of it.
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Lords ChamberMy Lords, we are all aware of the rising rate of infection, particular after this morning’s candid briefings, and the risks that it poses. Your Lordships will therefore understand the importance of taking the necessary steps to keep members of the public safe, while continuing to keep the economy running and schools open, and heading off the need for a second national lockdown.
We know that some of the rules put in place have become increasingly complex and difficult to enforce. That is why the Prime Minister has set out—or will set out—how we will further simplify and standardise local rules by introducing a three-tiered system of local Covid alert levels in England. This is not the subject of the debate today, nor does it change the legal requirement to wear face coverings, but it should reassure noble Lords that we continue to work with the local leaders to tackle outbreaks with more targeted restrictions that are simple and constructive.
The regulations being debated today introduced the requirement that members of the public should wear a face covering in taxis and private-hire vehicles. In addition, they should be worn when inside premises that provide hospitality, such as a bar, pub or restaurant, except when eating or drinking, for which people must be seated. This means that people must wear a face covering when entering, leaving and moving around the premises.
I think the Minister will find that we are supposed to be discussing the north-east, rather than the face coverings. It does not make any difference—I am quite happy to do them that way round, but we might get confused.
My Lords, I apologise and give great thanks to the noble Baroness for the polite and kind way in which she brought that to my attention. At this point, we are debating statutory instruments that apply to the north-east of England and were in force on 18 September. As your Lordships may know, a Prime Ministerial Statement in the other place will address these sorts of issues and we will of course keep a careful watch on the progress of that debate.
Over the past few months, local restrictions have allowed us to home in on areas where cases are high and rising, and put targeted measures in place. I understand that the measures we are debating have greatly affected families living in Northumberland, Newcastle, North Tyneside, South Tyneside, Gateshead, County Durham and Sunderland. Families in these areas are no longer able to meet relatives as they used to. I recognise the disruption the measures cause, particularly for those relying on often complex networks of grandparents and friends to help out with childcare. We must celebrate the complex civil communions which underpin so much of our day-to-day regimes.
However, this virus is transmitted by people meeting up with each other and the horrible truth is that the closer our friendships, the more relaxed we are in each other’s company and the harder it is to keep socially distanced. These measures are not taken lightly. They are driven by our public duty to protect the most vulnerable people in our society and do our utmost to ensure that this virus does not adversely affect these groups. What is of concern is that the number of cases in the over-60s is rising; we know that coronavirus symptoms can be more severe for people in this age group. I recognise that the Government are asking many people living in these regions of the north-east to make sacrifices to protect those most vulnerable to this virus. We will need to make adjustments to our daily lives until we have suppressed or eradicated this terrible disease.
Unfortunately, as cases have gone up in these areas, we need to introduce more of these local measures. On 18 September, we introduced new restrictions on household mixing, business opening hours and table-only service in pubs, restaurants and other places serving food or alcohol right across Durham, Gateshead, Newcastle, Northumberland, North Tyneside, South Tyneside and Sunderland. Unfortunately, again, despite these measures the number of cases continues to rise sharply. Incidence rates across these parts of the north-east area are now some of the highest in the country, with Newcastle’s rate now more than 534. So, at the request of the local councils, with which we have been working closely, we will introduce legal restrictions on families mixing with other families in their homes and being able to enjoy food or alcohol only if served at a table, and with non-essential businesses being required to close at 10 pm.
These are not steps that we take lightly but we must take them, and that is what we did because we know that swift action is more likely to bring the virus under control. The quicker we can do so, the quicker we can restore the freedoms we all enjoy—in the north-east and right across this country. Targeted measures were needed to tackle the outbreaks in those areas. The council leaderships collectively agreed that a ward-level approach would not be appropriate, as widespread community transmission had been observed in all areas. People move freely through the local authorities for work and leisure; for example, 40% of people who live in County Durham work in other areas.
These regulations prevent gatherings involving more than one household in private homes or gardens. There are exemptions for those in support bubbles, for example, and on compassionate grounds. We listened to feedback from the local leaders and amended these measures so that informal childcare support bubbles are allowed. Before the national restrictions for the same purpose, we tackled the risks of community transmission by allowing table service only in hospitality venues so that people cannot move about and pass on the virus. To reduce riskier behaviours often seen later at night when people have been drinking alcohol, we imposed the restriction on entertainment and leisure venues, limiting them to opening between 10 pm and 5 am.
Noble Lords will be aware that these regulations have since been amended so that they now also prohibit families meeting up with each other in any indoor space in these areas. We revised the guidance for owners and operators of indoor settings, including places of worship, to say that they should not intentionally facilitate indoor gatherings between households. We also advised that care homes should allow visits only in exceptional circumstances to protect their vulnerable residents. No restrictions have been placed on travel, but people have been advised not to travel with people from other households.
The Secretary of State is required to review the need for the restrictions at least every 14 days. The first review was completed on 1 October, and it concluded that the restrictions must stay in place. The next review is due this coming Thursday. I thank the seven local authorities for acting collectively as well as the local resilience forum, Public Health England, the joint biosecurity centre, local council leaders and the local directors of public health. I also thank the people in the protected area in north-east of England, who have responded so well to the measures put in place. It has been a tough year for many, and these regulations have a serious but necessary impact on how they live their lives. I beg to move.
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Lords ChamberWell, my Lords, our rule—if there is a rule—is that we are clear that our measures should be locally led. We work with local leaders first and communities to take swift action to prevent and manage outbreaks, ensuring that our responses work for them, supported by a national service which they plug into. It is for that reason that we are considering local tiers. Local alert levels or tiers are designed to standardise the interventions in place in local areas across England to make it easier to communicate what restrictions apply, and in what areas, to the public.
I follow on from the question asked by the noble Baroness, Lady Hayman. I thought the answer was remarkable, but maybe the Minister did not understand the question. In March, the Government were very keen to work with all parties and many others to get the emergency powers in place and, since then, really it has been nothing—letters to leaders informing them, diktats to local government, and accusations of undermining the national effort when legitimate questions are asked and comments are made. As we face another spike, will the Government change their habits and let stakeholders and Parliament, including your Lordships’ House, play a fuller role in designing and agreeing the national effort?
My Lords, I take exception to the noble Baroness’s characterisation of our approach. In fact, local planning and response are recognised as an essential part of our response to Covid, and are very much at the heart of the service. We want to have local outbreak control plans across the country. The development of local outbreak control plans is led by directors of public health; they are done on behalf of upper-tier local authorities, where the statutory responsibility for directors of public health sits, and are regularly reviewed by the local NHS, GPs, local employers, voluntary organisations and other community partners. There is also a link with local resilience forums, integrated care systems, combined local authorities and directly elected mayors as appropriate.
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Lords ChamberMy Lords, given the pattern and themes of complaints emerging during Covid, what will the role of the Health and Social Care Ombudsman be in the forthcoming inquiry into the pandemic? Will the Minister give a guarantee of full involvement of that ombudsman, given the evidence it can bring to the table?
My Lords, the nature of any future inquiry has not yet been defined. However, all parties will be taking learnings from Covid and bringing forward their lessons-learned experience. As the major regulator, the CQC will play a leading role in bringing together the data and information from the front line but, as the complainant of last resort, the ombudsman will also play an important role in that process by bringing insight from patients and those who have made complaints.
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Lords ChamberWe are seeking to extend asymptomatic testing as widely as we possibly can and as soon as we possibly can. At the moment, our focus for testing is on residential social care, where we have committed to 100,000 tests a day. That is where the greatest threat comes from. But as the number and range of tests increase, we hope to be able to roll out asymptomatic testing to a much broader set of user cases, and the kind of care centres that she describes will surely be near the top of the list.
My Lords, figures from the CQC show that there has been a 175% increase in unexpected deaths among learning disabled and autistic people during the pandemic. The Cabinet Office’s disability unit, which is charged with developing the national strategy for disabled people, has been silent so far. Does the Minister agree that, rather than Covid-19 necessitating delays for a national disability strategy, the impact of the crisis on disabled people makes its publication all the more vital? When will the national disability strategy be published?
My Lords, let me clarify with an update on the numbers. As of 25 September 2020, 690 deaths from Covid of people with learning disabilities have been reported to the leader programme since 16 March. We have commissioned Public Health England to carry out additional analysis of the existing data, which will be published as soon as it is completed. We are not trying to hide from this issue. Covid has raised very serious questions about the impact of a pandemic on those with learning difficulties, who are often more susceptible to disease and mortality than others. We absolutely accept the challenge of figuring out how to protect the most vulnerable in our society. Therefore, we will embrace the opportunity to take these learnings and put them into a disability report at some point in the future.
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Lords ChamberThe department is aware of the Queen’s Nursing Institute report on training and, although the majority of responses were positive, it raised questions about the training of, in particular, care home staff on the instruction to change resuscitation orders for patients without discussion. We are looking at that report very carefully. We cannot comment on individual cases but the report raises important questions. In the meantime, the General Medical Council is providing additional support and guidance to clinicians and the Resuscitation Council is creating a large range of resources for clinicians to help guide them and provide training.
I am pleased that the Minister has recognised that, although DNR is a medical decision and not something that requires a patient’s consent, not consulting with the patient and their family is an unlawful breach of human rights. We should be grateful that the scandal was exposed by Turning Point and other charities during the pandemic. Does the Minister have plans to review the DNR decisions that were made during the pandemic and does he know, or perhaps he can find out, how many DNRs were issued in excess of what one might have expected during the pandemic?
My Lords, NHSE&I is currently engaged with stakeholders, including people with lived experience, to develop better information for patients and to understand whether procedures need to be changed. I reassure the noble Baroness that DNRs are not issued, they are agreed with families and relevant loved ones. On no account should DNRs be unilaterally issued. They are for a joint decision; that kind of blanket application is something that we are extremely concerned about and seeking to avoid.
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Lords ChamberI reassure the noble Baroness that the use of non-official QR codes is rejected by the app. I have had personal experience of this. We have had downloaded 600,000 of the official QR codes—an astonishing figure. The use of those codes seems to have been embraced and adopted. I have one at my office and it works extremely well.
I confess that I am very confused by the answer given by the Minister to my noble friend Lord Foulkes about older phones. I have a friend who was excited about being able to download the app; her phone is only two or three years old but it was too old to download the app. I have to say that I am sceptical of the figures that the noble Lord has given us. Certainly, some who may or may not be in the lower income bracket, may be older, or may just be careful and have phones bought in 2015, seem unable to download the app at all. Did the noble Lord say there were two apps? This is confusing and I am not sure that it will help.
My Lords, I completely understand the concerns of those who may be struggling to download the app but I reassure the noble Baroness that the current app is supported by iOS versions 13.5 and higher, and by Android Marshmallow version 6.0. That covers by far the vast majority of phones. As I said, 89% of phones should support the app. They include, for instance, Apple iPhone 6S and above—a huge proportion of phones. We are debating a new initiative by Apple to bring in their own protocol that is particularly directed at developing countries which may not be able to support their own app. That initiative is not targeted at the UK. We believe that it may have some relevance in supporting downloads of the NHS app because the alerts created can perhaps be directed to the download site on the iPhone store to encourage those in the UK who have not yet downloaded the NHS app. The Apple initiative is a positive development that will be particularly well used in developing countries.
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Lords ChamberIt is true that there is a correlation between the mortality of this disease and poverty. That is why we have enhanced the funeral expenses payments by increasing the additional costs by £300. We are also supporting public health funerals by issuing new guidance to local authorities to support this important measure which brings a degree of quiet to those who die in poverty.
Does the Minister share my concern that older people and their families are picking up the tab, with many being forced to pay a steep and unexpected coronavirus bill by their care providers? Some care home residents are being asked to pay more than £100 a week on top of their usual care home fees as PPE and the cost of covering staff absences push the finances of some care homes into the red and threaten their sustainability? What consideration have the Government given to outlawing or capping such charges, as called for by Age UK? With a second peak under way and care homes under acute financial pressure, will the Minister commit to making sure that the Government’s emergency funding is directed to them?
My Lords, the noble Baroness is right to say that there are costs related to PPE for social care homes. That is why we have put together a winter plan for social care that envisages a massive investment in Covid-compliant PPE for care homes providing both adult care and child care. It will be free of charge for those homes. The money that we are supporting through the DWP funeral expenses payment and through the public health funerals programme has been enhanced. In 2018, £6.3 million was spent on public health funerals by local authorities and further sums have been allocated to support this important payment.
(4 years, 2 months ago)
Lords ChamberMy Lords, the Prime Minister claimed again today that the UK does more Covid tests than anywhere else in Europe. This is not true. Denmark does almost twice as many per 1,000 people, and the UK figure includes antibody tests, which others do not do, and is based on when tests are sent out and not on results. So it is more hyperbole.
I hope today we can look at facts. There is now a backlog of 185,000 swabs and tests are being dispatched abroad. Can the Minister advise the House how many tests have been sent abroad, to which countries, the processing time and the void rates? If the Minister does not have that information at his fingertips today, can he please to write to me and put the answer in the Library?
Secondly, Coronavirus infection rates among middle-aged people have reached the same level now as rates among those in their 20s two weeks ago, and Professor Neil Ferguson has warned us that infections are back where they were in late February. So what discussions have the Government had with the Joint Biosecurity Centre and the CMO about raising the alert level from three to four?
I am grateful for the noble Baroness’s questions. In terms of European rates, Britain is way ahead of many of its fellow countries in Europe. On Friday last week, we did 240,312 tests. It is a massive number and, I believe, the highest we have done on any day. This is a huge achievement and I pay testimony to those in the NHS and in test and trace who have contributed to that figure.
In terms of tests being sent abroad, our testing environment and economy are part of an international system. Reagents, swabs, consumables and machines are regularly exchanged between countries and I pay tribute to the enterprise and energy of the NHS and the test and trace scheme for using whatever schemes they can find in order to process the tests accurately, efficiently and promptly. I will be glad to send the noble Baroness details of the rates which she asked for.
In terms of the increase in prevalence among the middle-aged—yes, we are deeply concerned about this. As I have said at the Dispatch Box before, as night follows day, rates progress from the young to the middle-aged and, I fear, to the elderly. We are keeping a close eye on this progress.
(4 years, 2 months ago)
Lords ChamberMy noble friend is entirely right to raise the importance of social care. Undoubtably, one of the things that we have learned through Covid is that the NHS and social care sectors must work more closely together. That was always envisaged as one of the pillars of the long-term plan. It is now an increased priority. That has been witnessed through much closer collaboration in recent months between trusts and the social care industry. We continue to invest in social care, providing councils with access to £1.5 billion for adult and social care in 2020-21, as extra support during this difficult time.
Following on from the question asked by the noble Baroness, Lady Altmann, I must try to pin the Minister down. Can he commit to publishing a plan for the future funding and provision of social care by the end of this year, as the Prime Minister promised in January? My honourable friend Liz Kendall MP has today written to the Secretary of State about the need for a clear social care winter plan. What steps are the Government taking to ensure that no one with Covid-19 is discharged from a hospital to a care home, to prevent a repeat of the terrible impact that this had in the first months of this crisis?
My Lords, I cannot commit to a social care plan before the end of the year. It will require a huge amount of political collaboration and I suspect it will take longer than the next few months. I remind the noble Baroness that we have a £600 million infection control fund to help social care through the winter.
(4 years, 2 months ago)
Lords ChamberMy Lords, I entirely agree with the noble Baroness that serious eating disorders are complex, and we need to resource the medical attention required by people with serious mental health issues. However, I do not completely align with her view that all obesity is not a matter of personal responsibility, nor that the education of people about the content of their food through labelling cannot be an important part of our battle against obesity. Covid has spelt it out clearly to all of us. Some 67% of the country is overweight in some way or another. But this is a policy that we are determined to get right, and I would very much welcome the opportunity to meet with the noble Baroness and her team.
My Lords, following on from the noble Baroness’s question, do the Government have eating disorder experts, including those with lived experience, advising them as part of their anti-obesity strategy? It seems to me that is one way of making sure that the messages do not disadvantage those who have eating disorders. There is a reason why advocates for those with eating disorders have been very critical of the language being used. Could the Minister commit to reviewing the campaign in light of this?
(4 years, 2 months ago)
Lords ChamberMy Lords, our assessment of the recent rise in positive tests is that we are deeply concerned, particularly about rates among young people, and particularly at a time when children are returning to schools and people are returning to the workplace. We are constantly looking at the latest data on the spread of coronavirus and have worked hard to contain outbreaks early to reduce the spread, protect the NHS and social care sectors, and save lives.
I thank the Minister for that Answer. I was finding it difficult to know in which direction to point myself in framing a question about our testing system, but he has given me the two issues that I want to raise. First, can he tell the House what effect the increase in Covid infections is having on R? What is SAGE advising? The second question is to do with schools. What is a head teacher to do when they have successfully got their pupils back into school and then inevitably have pupils who have symptoms, are at home and need a test—as do their families—but are unable to get one because the nearest centres are either not carrying out tests or have run out of them, the labs cannot process them, or they have been offered testing many miles away and may not even have a car? How are our schools to remain open and safe if the national testing system is not working as it should, and when will this be resolved?
My Lords, the impact on R is not entirely clear at the moment. ONS and REACT figures will be published shortly, and they will have the statistical analysis that the noble Baroness asks for. However, it is safe to say that R is up. With regard to schools, the Government have made it clear that our support for the return to schools is completely emphatic. However, I remind the noble Baroness that the average distance travelled for tests, even at this stage, remains 6.4 miles. Ninety per cent of people who book a test travel less than 23 miles, and 90% of tests undertaken in our mobile sites are still converted in 24 hours.
(4 years, 2 months ago)
Lords ChamberI remind the noble Lord that, in July 2018, the standard of proof used by coroners to determine whether a death was caused by suicide was lowered from criminal to civil. That has had a meaningful effect on the number of suicides recorded. I am afraid the numbers for Yorkshire and Humber are not available to me.
My Lords, we need to return to statistics. Last week, the Health Secretary Matt Hancock told the House of Commons that new figures from the ONS showed that the number of suicides in England fell during the peak of the coronavirus pandemic. Could the Minister confirm to the House that this was mistaken? While the figures cited by the Health Secretary are the latest reported by the ONS, the ONS also clearly said that those figures
“cannot be used to show the number of suicides with a date of death in 2020, including those that occurred during the COVID-19 pandemic”.
It is likely, it continues, that it
“reflects delays to inquests … due to the impact of the COVID-19 pandemic”.
As government statistics show, the last time the suicide rate was this high was 1988. I would like to know what government resources are being applied to this and that they will not be cut back.
(4 years, 2 months ago)
Lords ChamberTo ask Her Majesty’s Government what plans they have to publish the scientific advice which informs decisions to lift restrictions put in place to address Covid-19 in specific local areas.
My Lords, data is the key scientific commodity in our fight against Covid. We started with very little; now we have lots, and we are sharing it with our local partners as quickly as the legal, technical and privacy constraints allow. This shared intelligence informs collaborative decisions on local restrictions.
I thank the Minister. On the ministerial Zoom, I witnessed the Conservative MP for Shipley having what looked like a hissy fit when the Bradford lockdown was announced. Despite recommendations to the contrary from the leader of the council and local public health officials, a month later Shipley has been lifted out of lockdown when other parts of Bradford still in lockdown have lower infection rates. On Friday, the Health Secretary announced that restrictions in Bolton and Trafford would be eased on Wednesday, despite leaving Labour constituencies with lower infection rates in lockdown. It seems that the Government were again lobbied by local Conservative MPs to lift restrictions. However, yesterday, the Health Secretary, with what might be called a skidding U-turn, announced that current restrictions would remain following a significant increase in infection. Will the Minister commit to publishing the scientific evidence behind decisions to impose, maintain and lift lockdown restrictions? Would it be better if discussions with local MPs were on the record? Does he agree that political neutrality and transparency are essential to securing public trust and support for measures locally to prevent a national lockdown?
My Lords, I entirely agree with the noble Baroness that local support, trust and collaboration between actors from all political parties are essential to fighting Covid effectively. I pay tribute to the very large number of dialogues and collaborative interventions we have had across the country with local actors from all political parties. Yes, local lockdown decisions are not always popular. They are tough choices and elected representatives find them difficult, but we have found that politics does not play a part in those decisions and we stick to that.
(4 years, 2 months ago)
Lords ChamberHealth checks in the early years of childhood are an incredibly valuable opportunity to intervene in a number of health inputs. Diet and exercise are two of those. Training is in place for health visitors to provide dietary advice but, when back at the department, I will ask whether we are working on any new initiatives at the moment and write back to my noble friend.
I have two questions for the Minister. Could he explain to the House why Professor Dame Sally Davies’ 2019 report on childhood obesity, which made 49 recommendations, seems to have been lost? Given that Public Health England plays a crucial role in addressing obesity, as my noble friend Lord Dubs said, and the obesity team seems to be homeless at present, how will the Government ensure that its expertise, accountability and leadership is retained and relevant bodies are sufficiently funded?
My Lords, the report from Professor Sally Davies has not been lost; the July obesity strategy leans extremely heavily on the insight and advice of Sally Davies, who continues to have a strong presence in the department and informs all our decisions, as does the public health team at PHE. Professor John Newton had an extremely high profile during the launch of the obesity strategy in July and continues to have an important voice at all levels of the department.
(4 years, 4 months ago)
Lords ChamberMy Lords, I completely recognise the power of the smoking bans, as well as the threat of young people taking up smoking and sticking with the habit for a long time. We are on track to meet our national ambition of reducing under-15 smoking from 5.3% in 2018 to 3% or less by 2022. However, even that seems too high and we will continue to work on our efforts.
My Lords, it would be nice if, on his birthday, we could get to my noble friend Lord Simon, so my question is very short—fewer than 75 words. Inequalities in smoking remain the largest cause of life expectancy gap between the rich and the poor and are the main reason for the lives of people with serious mental illness being shortened by up to 20 years. Does the Minister agree that the smoke-free ambition may be achieved only by the most advantaged and will the Government’s further proposals address this inequality?
Health inequalities are one of the most pernicious and difficult aspects of modern life and the Government are focused on them. Smoking is a graphic example of the worst of our inequalities. That is why the prevention Green Paper focuses on these kinds of inequalities and why our response will be muscular and determined.
(4 years, 4 months ago)
Lords ChamberMy Lords, turnover of the test and trace team is an inevitable consequence of an organisation that was set up using temporary staff, many of whom are on short contracts and need to return to their previous roles. It is regrettable, but I owe them a huge debt of thanks for the work they have done. The work of McKinsey is focused on governance, not on HR. It was commissioned some time ago and it is an entirely proper and regular appointment.
My Lords, I refer back to what the noble Lord said about the amount of PPE that is needed. It is actually the case that in the 2016 report it was signalled that we would need a gigantic quantity. I am sure we would all agree that we need better organised and effective preparation if there is to be a second wave, and the centralised purchasing of PPE, managed by local public health agencies, will ensure effective distribution. I want to ask about the care sector. Does the noble Lord believe it is acceptable or wise for care homes to have to pay over the top prices and compete for PPE? Does this not put the wider public health interests at risk? What steps is the Minister taking to end discrimination against the care sector in the supply of PPE and ensure essential protection for care workers, residents and visitors?
My Lords, it is a reality that the cost of PPE has gone through the roof. There is nothing that I or the Government can do about that. It is something we are going to have to live with and budget for: it is part of the new reality. As to the procurement of PPE, as the noble Baroness knows, within the care sector it was previously the arrangement that local providers would source their own PPE. The Government have stepped in to bring resilience and confidence to that supply chain and to offer alternative sources of supply to local care homes. We have moved emphatically and sought to bring both affordability and resilience to the supply chain.
(4 years, 4 months ago)
Lords ChamberTo ask Her Majesty’s Government what steps they are taking to ensure that ethnic diversity is fully reflected in all aspects of medical teaching and learning.
My Lords, the Government understand the importance of racial equality and diversity within the NHS and are committed to ensuring that this is reflected in medical training. We think we could do better, which is why the General Medical Council sets standards to ensure that students and doctors in training have the opportunity to understand the needs of patients from diverse social, cultural and ethnic backgrounds. That is why Health Education England provides a learning module on equality, diversity and human rights for all health and social care staff.
Thank you, my Lords. I thank the Minister for that Answer. We live in a multiracial society; our NHS serves everyone and is staffed by everyone. However, the training of our doctors, nurses and medical technicians appears not to reflect this fact. We do not know whether current clinical language and learning has exacerbated the dangers to patients from a BME background during the pandemic, for example.
I pay tribute to Malone Mukwende, a student at St George’s, University of London, who published Mind the Gap as guidance for healthcare professionals, showing how skin conditions manifest on darker-skinned patients. This is a question of medical training, not a question of options that people might opt in to. We have to integrate these issues into our medical training to ensure that all healthcare professionals are able to recognise, diagnose and treat all our citizens from all ethnic backgrounds. Are the Government going to act on that?
My Lords, I welcome the noble Baroness’s point. She is entirely right that we live in an extremely diverse community, and this has an impact not only on the way people present their disease but on how they could and should be treated. This is why we build diversity awareness into our training and why we will build extra programmes into the People Plan that will be published shortly, and that is why we remain committed to this agenda.
(4 years, 4 months ago)
Lords ChamberHealth records are absolutely key—that is why we have tabled an amendment on them. That amendment enjoys the support of the Government and of me personally.
I think we can see that we need a longer discussion on this report. It is quite clear that some of its excellent recommendations will require primary legislation and I hope the Minister may have identified them already. We on these Benches are keen to co-operate with the Government and across the House to bring forward the necessary amendments to the Medicines and Medical Devices Bill.
The HSSI Bill is an incredibly important part of our agenda. It is not currently on our schedule, but we hope to bring it back at some date, or incorporate its contents in another vehicle.
(4 years, 4 months ago)
Lords ChamberMy Lords, the precise remit of any review will be the choice of those doing the review when it comes, but I entirely endorse the noble Baroness’s sentiments that the social care workforce is worthy of our respect, particularly for its hard work and commitment during the epidemic. Workforce remuneration has improved since the introduction of the national living wage in 2016. Flexible contracts suit many workers, so a blanket commitment to annual wages is not necessarily suitable, but I endorse a focus on solutions that encompass all aspects of the social care industry, including the workforce.
My Lords, following on from what the noble Baroness, Lady Brinton, said, the Minister’s party has form for not honouring cross-party co-operation on this issue. To mitigate that, given that the Prime Minister has said that he is currently finalising plans, perhaps the Minister could commit the Government to setting a firm date and a timetable that could be published before the House rises for the Summer Recess? Does he accept that we need a plan to be delivered within a year?
The noble Baroness is kind to think that I am in a position to articulate a timetable from the Dispatch Box—that is beyond my abilities. However, she is entirely right to focus on the urgent need to focus on this area. The Prime Minister and the Secretary of State could not have been plainer that when the time is right and we have dealt with the epidemic, social care reform will be uppermost in our mind and will be the focus of our attention.
(4 years, 4 months ago)
Lords ChamberLast Wednesday, the Minister advised noble Lords that the lockdown in Leicester was being carried out under the Public Health (Control of Disease) Act 1984 and that regulations would not be brought to the House. However, on Friday, Leicester regulations were laid. Can the Minister clarify that and explain why there was some confusion and whether this has any practical consequences for implementation and enforcement in Leicester? Will this apply to other cities such as Bradford, Barnsley or Oldham? At Prime Minister’s Questions just now, the Prime Minister stated that the risks associated with asymptomatic transmission were unknown until recently. This is not the case. I am very happy to provide the Minister with SAGE minutes from 4 February, for example, when precisely that was recorded. Can the Minister clarify that statement for the House?
My understanding regarding the 1984 Act is that the regulations are published under the appropriate section. They have been published as is appropriate, but they are not brought to the House for debate. If I am wrong, I will be happy to write to the noble Baroness.
(4 years, 4 months ago)
Lords ChamberThe noble Baroness puts her question extremely well, but I am afraid it is beyond my ability to predict as she asks exactly what the shape of the national care provisions will be. What I can say is that the role of agency staff was always, from the very earliest stage, one of the gravest concerns we had. The CMO flagged it very early, and we moved as quickly as we could to tackle the difficult issue of itinerant staff, and to put in place both the funding and the procedures to anticipate problems of infection around staff who move from one home to the next.
My Lords, I return to the question raised by my noble friend Lady Armstrong and the noble Baroness, Lady Brinton, because, while it is obviously welcome for the Minister to thank those who work in care homes for the sacrifices that they have made, he needs to acknowledge the hurt that the Prime Minister has caused with his words. Will the Minister clarify which procedures care homes are accused of disregarding? Are they procedures related to the Government’s policy of allowing hospital patients to be discharged without testing, to the failure to provide the required PPE or, perhaps, to setting up the testing programme so late?
(4 years, 4 months ago)
Lords ChamberThe noble Baroness will not be surprised to learn that I have just spent three and a half months looking at drugs that might make a difference to Covid, only to find that many of them are not helpful and often quite dangerous, so I do not share the optimism bias that many have towards unlicensed drugs. We remain conservative in our approach to clinical trials. I agree with the noble Baroness and others who have suggested that progress on this should be quicker, and I am leaning into the subject to try to bring that about as soon as we can.
My Lords, it is deeply concerning that no new NHS prescriptions for full extract cannabis oil have been issued since the medicinal use of the drug was legalised more than 18 months ago. This leads to a health inequality: 313 private prescriptions for unlicensed cannabis medicine items, including full extract oil, have been issued. Does the Minister share my concern that only wealthy families and those who can successfully raise funds in the region of £2,000 a month have access to cannabis medicines, while children from poorer families who are unable to afford the prescription are going without? What does he think needs to happen next?
The noble Baroness shines a spotlight on an uncomfortable but realistic fact of life in our medical service: those with money are able to pay for treatments beyond the reach of those who rely on the NHS for absolutely everything. Another area that concerns me is that those who have relied on fundraising have found that Covid has restricted the amount of money coming from donors. That is why we have put money into medical research charities and support charities that can help support those fundraising for their medicine.
(4 years, 4 months ago)
Lords ChamberMy Lords, I am as concerned about the over-prescription of anti-depressants as the noble Earl and would much prefer people to take cognitive therapies than drugs wherever possible. As I mentioned earlier, we have invested in two major rounds of support for community groups to help those struggling with their mental health, and we are reviewing additional funding for those schemes. We will keep a careful eye on the prescription of anti-depressants, which we are all concerned about.
My Lords, health and social care workers battling through the coronavirus pandemic are paying a heavy mental and emotional toll and will continue to do so. Yet the current mental health support available is not adequate. Will the Government commit to appointing a new independent national well-being guardian to co-ordinate and oversee a proper mental health support package for all NHS and care staff?
(4 years, 4 months ago)
Lords ChamberI return to the Question asked by my noble friend Lord Bradley. We know that around a third of schools currently do not provide school-based mental health support and that many young people struggling to cope will not meet the criteria of the NHS mental health services in their area. Will the Minister consider the request of Young Minds for the Government to provide ring-fenced funding to ensure that schools can bring in the extra support needed to help their children?
I should be very glad to look at that request and would be grateful if the noble Baroness would forward it to me. The Young Minds movement is very important. I would say that young people, particularly girls, have been a focus of mental health issues. That has come out in the figures and it is a situation that concerns us.
(4 years, 5 months ago)
Lords ChamberMy Lords, I would like to say an enormous thanks for a valuable and important debate. Over the coming weeks and months, we will continue to ease the restrictions put on individuals, society and businesses by these regulations as it becomes safe to do so. The amendments debated today play an important role in that gradual return to normal life, as outlined in the Prime Minister’s Statement on Tuesday. I remind noble Lords that the Leader of the House was here earlier holding a debate on that Statement, as she has done when there have been other announcement of a similar nature. I acknowledge the value of giving people warning of these changes, as referenced by the noble Lord, Lord Hunt, and I acknowledge the frustration of the noble Lord, Lord Purvis, and the noble Baroness, Lady Thornton, about the sequencing of these amendments, which I think I addressed in my earlier comments.
I am pleased that, as of 4 July, we will relax additional restrictions in a safe way. This is an exciting step towards a more normal way of life. Nevertheless, this return to normal life requires constant and careful surveillance of the latest epidemiological evidence, making changes only when the facts suggest it is safe to do so. We understand the burden these restrictions have placed on not only individuals but society as a whole, so the Government will maintain only the restrictions that are necessary and proportionate.
To reassure my noble friend Lady Wheatcroft, and in reply to the thought-provoking challenge made by my noble friend Lord Robathan, I say that, whatever the argument of those who are sceptical of the evidence-based approach to science-led policy-making, the Government are determined to be led by the science. We will sometimes be in conflict with public attitude and the headline writers, but that will remain our commitment. On that point, I cannot hide from the House that we remain ready to reimpose stricter measures if it becomes necessary. As the Prime Minister outlined in his Statement on Tuesday, we will not hesitate to apply the brakes if a national-level response is required.
The debate has provided an opportunity for Peers to raise points relating to the whole spectrum of our activity. I remind the noble Baroness, Lady Jones, that on 23 March the French Government declared a widespread state of emergency that granted the executive branch enormous powers. This has not been our approach. I assure her that trial by jury remains a cardinal tenet of the British constitution.
I will take a moment to address some of the issues highlighted by noble Lords. I start by paying tribute to the noble Lord, Lord Campbell-Savours, for his remarkable and determined perseverance on masks and distancing. In part due to the kind of pressure that he has characterised, our advice will change from 4 July to one metre-plus, which is one metre’s distance plus mitigations when people cannot stay two metres apart. These mitigations will depend on the workplace or setting. For example, people must wear a face covering on public transport since it is not always possible to stay two metres apart. Put another way, this is one metre plus a face covering. In other spaces, mitigations could include installing screens, making people face away from each other, putting in handwashing facilities, minimising the amount of time people are together and so on. Having mitigations in place at one metre can be broadly equivalent in reducing transmission to staying two metres apart. We have set out Covid-secure guidance to help businesses take the measures that are right for them.
On face coverings, in reference to my noble friend Lord Blencathra, the noble Baroness, Lady Meacher, and the noble Lord, Lord Campbell-Savours, who I mentioned, I say that passengers have been told they will be required to have face masks when travelling from 15 June. There are some exemptions for health, age or equality reasons. Transport usage has been slowly increasing as restrictions are lifted. Social distancing remains the most important way to keep safe, but on public transport it is not always possible to follow this guidance.
Will the Minister give way? I know that it is a strange thing to ask these days. I am using public transport all the time to get to and from your Lordships’ House. I can report that particularly men and young men are not wearing their masks.
The noble Baroness is entirely right. It is incredibly tough to persuade people to wear their masks. There is a huge cultural gap. That reason and the insights of our behavioural scientists have led us to move relatively slowly, despite the articulate and passionate exhortations we have had on this subject. We are looking at ways to encourage mask wearing, but it is a struggle and not one that we think that we can necessarily rely on.
On non-essential retail, in response to my noble friend Lady Anelay, I say that I have recently met the Association of Medical Research Charities and I acknowledge the pressures faced by good causes supported by charity shops. The Prime Minister announced a timeline for the reopening of non-essential retail businesses on 25 May. I hope very much that that can bring some relief to that important sector.
We completely understand the impact of the lockdown on the hospitality industry and, as the noble Lord, Lord Scriven, alluded to, garden parties. That is why I am pleased that, following the Prime Minister’s announcement, significant parts of the hospitality and tourism industry will reopen from 4 July. However, to make sure that this is done in as safe a way as possible, all hospitality indoors will be limited to table service. Our guidance will encourage minimal staff and customer contact.
The regulations made on 12 June permitted the use of places of worship for individual prayer. Following the Prime Minister’s announcement on Tuesday, this will be relaxed further and places of worship will be permitted to be open more generally. In response to the noble Baroness, Lady Jolly, I say that this will be a welcome change for those who have been unable to use places of worship for their usual religious practice, and I thank those who have made sacrifices.
In response to my noble friend Lord Naseby, I say that here is no avoiding the fact that singing spreads an aerosol of virus-laden moisture into the air. On cricket, in the words of the Prime Minister, it is plain to everyone that the cricket ball is an infectious vector of disease spreading. I assure the noble Lord, Lord Clark, that we will not hesitate, in the face of a local spike, to bring back whatever lockdown measures are required to save lives and protect the NHS.
The noble Baroness, Lady Ritchie, asked about progress on vaccine development. I am delighted that the UK is taking a leading role in this work. Our best chance of defeating the virus is by working together globally. We have put £84 million into accelerating the work of Oxford University and Imperial College. I pay testament to the work of the scientists there. The noble Baroness also asked about social care; we have set out a comprehensive action plan to support the adult social care sector in England throughout the coronavirus outbreak, including ramping up testing, overhauling the way PPE is delivered to care homes and helping minimise the spread of the virus to keep people safe.
In response to the noble Baronesses, Lady Thornton and Lady Brinton, we cannot avoid the costs of PPE. The global price of PPE has risen dramatically. These costs will have to be borne somehow, somewhere. We are working with Treasury and DH colleagues to figure out ways in which they can be borne.
In response to the noble Baroness, Lady Brinton, on shielding, from 6 July those shielding can spend time outdoors in a group of up to six people, including those outside their household. This can be in a public outdoor space or a private garden. Also from 6 July, those shielding will be able to create a support bubble.
I have answers to questions from a number of noble Lords, including on the devolved Administrations, parliamentary scrutiny and local powers. I will not be able to get through all of them in the time remaining. I thank noble Lords for all their contributions and valuable points during this debate. I reassure the noble Lords, Lord Rennard and Lord Liddle, that a lessons learned process will be undertaken when the time is right, but we are not through this yet.
These regulations have been hugely successful in tackling the spread of the virus. While recognising some local limitations, as mentioned by the noble Lord, Lord Goddard, we are enormously grateful to the public for their sacrifices and to the NHS and social care workers for their hard work on the front line.
(4 years, 5 months ago)
Lords ChamberTo follow on from the question asked in the previous debate by the noble Baroness, Lady Rawlings, in the last week the Secretary of State, when explaining the failure of the NHSX app, said that the Government are committed to trying and supporting any innovation that might work in this pandemic. That attitude is to be applauded, as long as it is not linked to exaggerated promises—and of course it means that some things will not work. It is therefore puzzling that the Government refuse to partner and adapt the Covid Symptom Study app, which might close the gap on the two-thirds of infections not currently being identified and fit into the existing human contact tracing effort. Some 3.5 million of us take 30 seconds a day to report our health; with government support, that could easily and quickly be 10,000,000. The founders from King’s College and ZOE have written to the Prime Minister today. In the spirit of trying everything to find a solution, will the Minister encourage a positive response to that initiative?
My Lords, I pay tribute again to those at KCL who developed the symptom-tracking app. The information from it has been enormously helpful over the last few months. In many ways we have benefited from the app’s independence as a source of important front-line intelligence. I am aware of the letter written to the Prime Minister, and I hope very much that we will be able to work more closely together. The information on asymptomatic references is very important. However, I stress that the ONS study suggests that, unfortunately, many people who declare the symptoms of coronavirus are mis-self-diagnosing, and we have to bear that factor in mind.
(4 years, 5 months ago)
Lords ChamberThe noble Lord is entirely right that the role of nurses in the healthcare system has been extremely well exemplified by the response to Covid. The £5,000 bursary was agreed in collaboration with, and with the input of, the Royal College of Nursing. There is of course other support that students can already access through the student loans system and the existing learning support fund, and that goes a long way towards paying for childcare, travel and other costs in cases of exceptional hardship.
My Lords, does the Minister agree with the Chief Nurse, Professor Mark Radford, that student nurses who volunteered to be redeployed on the front line during the pandemic are now feeling cast aside due to the uncertainty about their future, with some finding themselves out of a job but still with debts of up to £30,000 from having done a degree? If he does agree, can he say what the Government intend to do about making them feel less abandoned?
The noble Baroness raises a very concerning point. I take the Chief Nurse’s advice and observations at face level. I express my profound thanks to all those nurses who have been redeployed to the front line and have performed an important task but who are now feeling a sense of either anti-climax or uncertainty. I reassure them that there is an enormous number of job opportunities in the NHS, that there is a role for them in the NHS of the future, and that we will be investing massively in the role of nurses in the years ahead, as exemplified by our commitment to recruit.
(4 years, 5 months ago)
Lords ChamberMy Lords, the report is extremely helpful and throws a spotlight on an issue that we are deeply concerned about. Immediate help includes a £4.2 million support fund for mental health charities, and a £5 million fund for Mind, specifically to support charities dealing with Covid-related mental health issues. We will continue to invest in mental health in the long term, to support this important area.
My Lords, four in 10 pupils are not in regular touch with their teachers, there is a sharp educational divide between the rich and the poor, one in eight children and young people already has diagnosable mental health conditions, and the IFS research now reveals that those groups with the poorest mental health pre-crisis will see the largest deterioration. Does the Minister agree that the Government should put the same amount of resource, energy and imagination that they put into the development of the Nightingale hospitals, for example, into getting our children and young people back to school? Will the Minister commit to the YoungMinds five-point plan, which includes additional support for young people’s mental health as we move out of the pandemic, to meet rising demand, including recommitting to the measures outlined in the NHS Long Term Plan, in full, and funding additional early intervention services?
My Lords, the noble Baroness, Lady Thornton, raises an important point on the mental health of young people. A primary concern is the effect that the epidemic has on young people, at a delicate stage of their development. However, the return to schools is a very delicate matter. It requires the confidence of both parents and young people. We do not want to create further distress or concern. Therefore, we are taking steps in a thoughtful and measured fashion, to ensure that both pupils and parents are confident about the journey back to school.
(4 years, 5 months ago)
Lords ChamberI should first like to pay tribute to all those who have been involved in setting up the Nightingale hospitals. People have worked extremely hard to deliver a valuable service to the country. Bed allocation arrangements are made by local trusts and testing within the NHS is now intense. Decisions on the traffic of staff between safe zones and non-safe zones are taken by the local director of infection control.
My Lords, it is important that the Minister informs the House about how beds there are in the private sector, how many were occupied, at what cost and whether there will be a renewal. Does the noble Lord share my concern that if there is a second spike of Covid-19, it will lead to further delays in life-saving operations? What contingency arrangements do the Government have in place for this?
The noble Baroness is right to raise this concern. The bigger focus is less on the operational restraints, because the NHS has in fact done extremely well to keep the flow of operations going during this period. It is actually on demand. What we are most deeply concerned about is that patients return to hospitals and that their confidence in undertaking procedures is restored. That is why we have put a huge amount of emphasis on the marketing side of things. That is not to understate the importance of the operational side, but it is patient confidence that is our focus at the moment.
(4 years, 5 months ago)
Lords ChamberFirst, will the Minister say what weight the Government attach to the science presented in the figures that the Centre for the Mathematical Modelling of Infectious Diseases at the London School of Hygiene & Tropical Medicine published, which state that R is above one in the south-west and north-west of England? Secondly, the regularly estimated national R rate appears to be a key driver of policy; accurate measurement of R depends on a world-class testing regime, not yet in place; the likelihood is that some geographical areas may have an R close to or above one; and effective local control measures rely on knowing the local R rate. Given all that, when will the system for more accurate measurements of R agreed with the relevant local authorities be available by localities, so that this information can be used to inform and adapt the emerging local planning led by directors of public health?
The London School of Hygiene & Tropical Medicine’s report is one model of more than a dozen that contribute to the SPI-M committee, which looks at modelling. We value it, but it is not the only model. Regarding the statistical analysis of R, I pay tribute to the Office for National Statistics, which has put in place a massive testing programme to look at prevalence across the country. Hundreds of thousands of tests are done. This is by far the gold standard in terms of understanding prevalence and it feeds in accurate, up-to-date information for the accurate assessment—not modelling—of R0. It is on that work that we depend.
(4 years, 5 months ago)
Lords ChamberThe noble Baroness is entirely right: there is nothing new to the impact of Covid on those with a high BMI; it is entirely consistent with the impact of other diseases. She is also right that one of the nasty aspects of Covid is its long-term effects, which are not fully understood yet. Evidence suggests that these may be extremely damaging, and it is true that the Prime Minister has spoken about the impact of Covid on him. I have had pneumonia; I know the long-term damage of these kinds of diseases on people. We are looking very hard at offering the kind of support that she describes to those who have been hard hit by Covid.
My Lords, as many noble Lords have said, obesity is a significant risk factor in Covid-19. It is critical that we turn the tide on obesity at the earliest opportunity, and this means starting early in life. What steps are the Government taking to implement the measures outlined in chapter 2 of Childhood Obesity: A Plan for Action? Will the Minister commit urgently to restart existing plans to reduce salt, sugar and calories in our everyday foods, extend the soft drinks levy to other sugary and high-calorie foods, limit the advertising of junk food to children and ensure that people are not inundated with promotions for unhealthy food and drink?
The noble Baroness is entirely right that chapter 2 outlines an extremely thoughtful roadmap for how to address this issue. It is currently being reconsidered. I cannot make the guarantees she asked for from the Dispatch Box, but I can assure her that we are working hard to see how we can use the example of Covid to make progress on this important agenda.
(4 years, 6 months ago)
Lords ChamberMy Lords, the NHS chief executive, Sir Simon Stevens, has written to all NHS organisations signalling a change in the phasing of our response to Covid and inviting them to return operations given over to Covid to their previous use wherever possible. I hope very much that this will lower the impact on patients that the noble Baroness described. If she has a specific example in mind, I would be glad to inquire about it.
Is the Minister aware that some NHS trusts are diverting 999 and GP emergency admission calls to hospitals other than the nearest hospital to avoid transmitting Covid between patients? Can he tell the House when that will stop? Do the new guidelines allow the Government to provide finer-resolution data on hospital admissions, which will assist understanding of optimal admission, treatment and resource allocation strategies?
(4 years, 6 months ago)
Lords ChamberThe arrangements for eye care, similarly, are an extremely delicate matter, because the eye is a potential source of infection, and both workers and patients are at risk through work done by opticians. We are extremely keen to get back to normal, but we put the safety and care of patients and staff first.
My question to the Minister is an amalgam of those already asked, and I want to press him on them. Everyone needs dentists to be able to survive this pandemic and to be open to do their job as soon as possible. What financial support might be given to the sector to make that happen? What steps are the Government taking to ensure that there are treatment guidelines and access to PPE?
My Lords, I completely endorse the point made by the noble Baroness, Lady Thornton. I lost a front tooth a few weeks ago and I cannot wait for the dentists to reopen because it is both uncomfortable and embarrassing. We are providing enormous financial support through NHS contracts, which we have honoured 100% through the epidemic whether or not dentists are seeing patients. However, we recognise that there is a problem with the private sector, and we are working with colleagues in the Treasury to try to find a solution.
(4 years, 6 months ago)
Lords ChamberThe noble Baroness is entirely right. I am living with four children who are greatly distressed at losing their friends and not being able to stay in touch in the way they would like. We will undoubtedly need to provide support to schools to cover a list of mental health issues. The Secretary of State for Education is working on plans for that.
My Lords, as a nation, a vast number of us have seen our mental health deteriorate during the coronavirus crisis, so the challenges facing our mental health services are even greater than they were before. Surely we need a strategy to take us through the Covid-19 pandemic that takes account of the most welcome promises in the NHS long-term plan and addresses and scrutinises the impact of the pandemic on mental health and learning disability settings, including the impact of the temporary measures in the emergency legislation. Such a strategy must address how and when the DoLS legislation will be rolled out, and when and how the Government will bring forward reforms arising out of the review of the Mental Health Act. Does the Minister agree that these are the key ingredients of such a strategy? When will we see progress in this area?
The noble Baroness is right: the Covid epidemic will throw a spotlight on our mental health provision. That provision is already benefiting from an extra £2.3 billion a year by 2023-24. We have already brought forward the 24/7 crisis lines that were due to be delivered in 2023-24, and I think there is a good case for bringing forward other parts of our mental health strategy to address mental health issues during the Covid epidemic. Undoubtedly, we will focus very shortly on ways of doing that.
(4 years, 6 months ago)
Lords ChamberMy Lords, ID cards do not form part of the British tradition. We work on a system of consent and we have a very high level of trust in the Government. The app is particularly well suited to a country that has a universal NHS system, and that is one reason why we have designed it in the way that we have.
Can the Minister confirm that the national rollout of the NHSX app has now been delayed until June? Does he share my concern that a government spokesperson has said that it is possible for the test and track system to work without an app, and for the lockdown to be relaxed further without a system operating at all? This is deeply worrying, given that the Government have admitted that they should never have stopped track and trace in the early stages of the pandemic and now appear to be reneging on a commitment to make it a priority.
My Lords, it is entirely right that test and trace does not need a digital app to be effective. I reassure the House that prevalence levels are reducing across the country, as is the infection rate. It is only because prevalence and infection are reducing to manageable levels that we can even consider reducing the lockdown and maintaining pressure on infection through test and trace. The app brings many benefits of being able to automate millions of transactions a day, but it is not intrinsically necessary, and we believe that it would benefit from being introduced later, rather than earlier, than human-based tracing mechanisms.
(4 years, 6 months ago)
Lords ChamberThe noble Lord will know that we have set up one of the most ambitious surveys, conducted by the ONS, to study on a weekly basis a large number of viral and serological tests. Those are used by statisticians to understand both the prevalence and the spread of the disease. Figures for that are emerging—we now have three weeks-worth of figures. They are being published regularly and I would be glad to send the noble Lord a link to the relevant data.
My question is relevant to what has been in the news today concerning antibody testing. PCR testing is the most reliable but most resource-intensive test. Will it ever be sufficiently scalable for widespread regular testing of all key workers and to track clusters of reinfection? Are the Government investigating the potential of increasing the reliability of antibody testing by double testing? Now that a range of tests is being manufactured globally, will the Government publish their assessment of their relative efficacy in testing the two relevant antibodies?
The noble Baroness is entirely right. PCR testing is an important guide as to who has the virus, and we have made it available to all key workers who exhibit symptoms. However, we are sceptical of whole-population surveys. Double testing might help if there is damage to serological equipment, but the challenges of serological testing are more to do with the blood, and unfortunately people do not change their blood. We are very proud of British universities, which regularly publish assessments of the various serological approaches. That work is under way and continues, and we hope to make more progress on it in the months ahead.
(4 years, 6 months ago)
Lords ChamberMy Lords, a strange and peculiar feature of the epidemic has been that accident and emergency wards are, surprisingly, below normal capacity since people have sought to avoid them because of the obvious threat of the disease. That said, nosocomial infection is of grave concern. It is an inevitable and frequent feature of any epidemic, but we are applying new ways of working and seeking to section off those with the disease to ensure that the infection does not spread in our hospitals and from there into the community.
My Lords, I am pleased to note that today is International Nurses Day. I pay tribute from these Benches to all our nurses, at home and all over the world, for their work and courage in these dark pandemic times. I will ask the Minister about testing in our care homes. On 15 April the Government announced that they were rolling out testing to all care workers. On 28 April they extended this scheme to all staff and residents in care homes. Could the Minister explain why, then, yesterday’s strategy document set a target of 6 June? Which is it? It looks like the Government failed to meet the promise to provide the tests on time and have now moved the goalposts again.
I share the noble Baroness’s celebration of Florence Nightingale Day, which is an important day for the nursing profession and for all of us. We have made huge progress on testing in care homes in the last three weeks. The new portal was made live on Monday and care homes are now massively supported by satellite care home facilities manned by the Army. I am not sure about the 6 June date of which she speaks, but I reassure the House that care home testing is the number one priority of our testing facilities and is benefiting from the large increase in capacity.
(4 years, 6 months ago)
Lords ChamberThe noble Baroness is entirely right to point to the importance of ensuring that the vulnerable are included. Of course, the app is not the only thing we are depending on. Manual track and trace in the conventional way of using a telephone and speaking to those who test positive will still be a core part of our track-and-trace arrangements. Efforts will be made to reach those who are vulnerable or digitally isolated to ensure that they have details of the provisions for these track-and-trace arrangements.
My Lords, I would like to follow up on the question asked by the noble Baroness, Lady Lane-Fox, because she has put her finger exactly on how this may not work because either our most vulnerable and poorest communities will not have the technology or there will be problems with language. I would like some more detail from the Minister about exactly how the Government intend to roll this out. Given that it took such a long time to roll out the NHS volunteers system, I feel that we might find ourselves with our most vulnerable and poorest communities disadvantaged.
The noble Baroness is entirely right to be concerned about the vulnerable and our approach. I completely share those concerns. It is a massive challenge, but that does not stop us embracing the advantages of technology where millions of transactions can be done in a day which could never be done by more manual processes. An enormous amount will be invested in trying to reach out to those who are isolated, vulnerable or digitally excluded to ensure that they have details of our track-and-trace arrangements. Hiring an enormous army of track-and-trace experts has already begun, and details can be seen on my Twitter feed of how volunteers who have the right qualifications can join those efforts.
(4 years, 6 months ago)
Lords ChamberMy Lords, I thank the Minister for repeating this Statement. I point out that the Commons took an hour to receive and discuss this update; we are getting 10 minutes. It is almost two weeks since I saw the Minister across this virtual Dispatch Box, which seems a long time in a pandemic. When we went into lockdown in March, he seemed to indicate his enthusiasm for being accountable to the House in lockdown. I regret to say that I do not believe that he or his colleagues have matched that aspiration. I place on record that it is shocking that noble Lords across the House are reduced to submitting vital questions about Covid to a lottery—a ballot of topical questions. That is not serious accountability. Unprecedented times need unprecedented procedures.
I have two questions. First, will the Minister support a proposal that he and his colleagues should come to the House every day and have a Covid-related Question Time, morning or evening, which would discuss the contents of the daily press conference and other urgent matters? Secondly, how does the Minister intend to fulfil his promise to the House that there would be an eight-week review of the Covid emergency legislation? By my reckoning, those eight weeks will be up in two weeks’ time.
I welcome the noble Baroness’s questions on accountability. However, I remind her that not all Covid-related matters are covered by the department of health; Ministers have been in front of the House every day it has been open, answering questions on Covid, and they have given fulsome and thoughtful answers to questions and scrutiny. I welcome also her question on the eight-week review, which, as she says, is coming up in a fortnight. I will find out how the usual channels wish to mark that occasion in the House, and I would welcome the chance to submit the Government to scrutiny on the matter.
(4 years, 7 months ago)
Lords ChamberThe reference that the right reverend Prelate makes is an entirely right one. I pay tribute to the hard-working professionals in NHS and care home procurement. They have been caught in the eye of the most tremendous storm and, under extremely difficult circumstances, are working hard to meet the challenge. In particular, I pay tribute to the local procurement teams who are using their initiative to answer the challenge. Our approach to PPE procurement is one of collaboration with these sorts of local initiatives. I commend them, and they very much spell the future of PPE procurement.
I was going to ask about waiving regulatory requirements, but I will instead return to the question asked by my noble friend Lord Harris: is it the case that the Minister does not know the number of PPE required? My noble friend asked that question specifically. How much PPE is required on a daily or weekly basis? If the Minister does not know the answer, that is fine; he probably needs to find out and tell us.
The noble Baroness asks a perfectly reasonable question. I am afraid that I do not know the individual amount off the top of my head. I can tell her that, to date, we have delivered 135 million masks, 148 million aprons, 1.3 million gowns and 485 million gloves—more than 900 million items in total. The amount that we are providing increases every day. I will not hide from the noble Baroness or the House that this is a fast-moving situation. It is my impression that the demand for PPE will soon extend to other workplace situations and increase. It would be wrong to give the impression that this is a fixed amount that we should try to hit with short-term targets.
(4 years, 7 months ago)
Lords ChamberI completely agree with the noble Lord’s concerns, both about those who are clinically vulnerable and about the potential for a rise in non-Covid excess deaths. The second is a matter of extreme concern. The example of those with cancer who are going to hospital to have operations is a very good and clear example. These matters are very much at the highest level of the Government’s mind.
I thank the Minister. According to media reports, those who are particularly vulnerable to the virus could be advised to remain shielded for up to 18 months, or until a vaccine has been developed. Can the Minister confirm whether these reports are true? Secondly, the Government have recruited 700,000 NHS volunteers to support those who are vulnerable or shielded. Most of them seem to have been processed but many have been given nothing to do as yet, when there clearly is need. Will the Minister tell me how quickly that issue will be resolved?
The noble Baroness is entirely right. The prospect of long-term shielding for those most vulnerable is of deep concern. That is why we are pressing so hard on the disease, through the lockdown, to try to get R as low as possible. We will be putting in track-and-tracing measures to ensure that R can be held down and those in lockdown can be freed from their confinement. In terms of volunteers, the response has been incredible. It takes time to turn around all the offers of help that we have, but we are moving extremely quickly to do that.
(4 years, 7 months ago)
Lords ChamberThe noble Lord is right that the British public have been incredibly diligent, and I commend all those who have followed the guidelines to stay at home for the impact they have had on the infection rate and the mortality rate. However, we cannot fool ourselves into thinking that the epidemic is over. We have to be clear with, and level with, the public that any changes in the guidelines are some way off, and that they will be presented to the public when our understanding of the medium-term strategy is clear.
My Lords, I thank the noble Lord for the answer that he has just given, but it still begs the question of why the Government are treating the British public as if they were children. I am sure that it would be possible for them to share their thinking, even at this stage. My question concerns testing. Professor Paul Nurse, director of the Francis Crick Institute, said on 19 March about the way to deliver vital testing at scale:
“Institutes like ours are coming together with a Dunkirk spirit—small boats that collectively can have a huge impact on the national endeavour.”
Does the Minister agree with that approach? Can he tell the House when the Government will be able to utilise all the laboratory capacity, which will ensure mass testing and tracing, and will speed up the likelihood of an exit from the current lockdown?
The noble Baroness is entirely right. I have spoken to Paul Nurse and commend the Crick Institute on the work it has done to build up the remarkable capacity of 2,000 tests a day. However, there are practical issues with the “Dunkirk spirit”. There are enormous logistical challenges in getting swabs and serology to laboratories. There are logistical problems with them registering the correct patient details and then getting the responses back. We have made substantial advances—the Crick Institute has been a pioneer in this—in bringing industrial levels of organisation both to the very large number of tests done each day and to the logistical backbone necessary to process those results.
(4 years, 8 months ago)
Lords ChamberMy Lords, I start by welcoming this amendment, which in its spirit and intention is utterly sensible, thoughtful and right. I would like to speak on it in a way that reassures the House that the intention of the amendment and the many speeches in the Chamber today are exactly aligned with the way government is thinking and in which we have sought to build the Bill.
I also echo the many noble Lords who have mentioned the speech by the noble Baroness, Lady Grey-Thompson. Who could not have been moved by both the emotional way in which she explained herself and the very real and tangible anxiety of people—particularly in the disabled community, but anyone who depends on local authority services—who must feel incredibly vulnerable and worried that their affairs may not be given the priority they deserve, and may feel exposed and anxious about the future? That testimony was incredibly powerful and moving. It was taken to heart.
I also say a big thank you to all those who have engaged with us as we have drafted the Bill at pace, both at a senior level from major organisations such as the LGA and smaller ones and stakeholders. I assure the House that we absolutely are listening to groups that have concerns about provisions for their stakeholders. We have our ears open. The Government’s whole “protect life” strategy is shaped around an absolute priority of trying to save the lives, affairs and futures of the most vulnerable in our society. These provisions are here not because we want to leave anyone behind but because we want to enable local authorities to make the decisions they need to in order to make a fair, pragmatic and sensible distribution and prioritisation. It is our hope that these provisions will never come into play and that the commitment of resources we have made into the local authority area will see a generous and sensible provision for all those most vulnerable in society.
I will take just a moment to outline a few provisions that are in place, to reassure the House that we are not in any way removing all safeguards. For instance, I assure noble Lords that the Care Quality Commission will continue to provide independent expert regulation of health and care providers. It has already announced arrangements for a proportionate approach to ensuring standards of care over the coming period. We have published an ethical framework to provide support to ongoing response planning and decision-making. This sets out a clear set of principles and behaviours when challenging decisions on how to redirect resources where they are most needed and how to prioritise individual care.
We are working closely with the sector on additional guidance to ensure that procedures and prioritisation of needs operate in the best way possible during this period. The emergency Coronavirus Bill also contains provisions allowing the Secretary of State to direct local authorities to comply with the guidance we issue.
Legislation underpinning our crucial safeguarding arrangements to protect vulnerable people from neglect or abuse remains in place. That was a point that many noble Lords made very well yesterday. We are leaving all statutory duties relating to deprivation of liberty safeguards fully in place.
The noble Baronesses, Lady Hussein-Ece, Lady Thornton and Lady Uddin, all raised the question of carers. I assure the House that we totally agree with the intent of the amendment. We need to ensure that users and carers retain a clear voice in the coming period and are able to make their concerns known. Our guidance on the Care Act changes will cover this. A national steering group is leading the sector’s preparations for Covid-19; it includes both user and carer representatives.
The noble Lord, Lord Adonis, quite rightly raised the question of commitment to democracy and oversight. I assure the House that we absolutely embrace the ongoing functioning of Parliament. While I cannot speak for the House authorities and their arrangements for Parliament, I can speak for the health department. We are introducing technology there, such as video data and home-working, at pace. We are seeing a generational transformation in working practices in the last fortnight. These arrangements have been embraced, and I expect them to be embraced in other parts of the workings of the House.
We will also continue to report on the eight-weekly cycle. The noble Baroness, Lady Watkins, and others emphasised the importance of monitoring. We will put in place structures for providing the correct kind of monitoring.
The noble Lord, Lord Blunkett, rightly emphasised the importance of civil society, which is absolutely key, while the noble Lord, Lord Hain, emphasised the importance of volunteers. I reassure the House that the Bill contains extensive arrangements for a volunteer army to be recruited in a safe, orderly and accountable way and for funding to be put in place for volunteers. The Chancellor has announced generous and important provisions for charities; the noble Lord, Lord Hain, is entirely right that they have seen their donations dry up. They need support and provision if they are to play an important role against this contagion.
I completely understand the intent of the amendment in the name of the noble Lord, Lord Scriven. We have spoken offline about his concerns, which I have taken back. I reassure him that we have worked closely with the LGA and, in its dialogue with us, its emphasis has been on financial commitment rather than changes in the law. We have made a substantial £1.6 billion commitment but we will keep the question of legal changes under review.
The noble Baroness, Lady McDonagh, mentioned PPE, which although it lies to one side of this amendment is of concern to us all. I reassure the Chamber that a massive global procurement programme is in place. Distribution of existing PPE stocks is happening via the Army. A hotline has been issued to all front-line workers in the NHS and social care. We are moving fast and impactfully on that situation.
Lastly, we should not overlook Wales. The Welsh parliament has considered every question of this Bill and has signed off its legislative consent Motion. I am extremely grateful to Vaughan Gething, the Minister for Health and Social Services in the Welsh parliament, for his support.
For those reasons, I ask the noble Baroness to withdraw her amendment.
I thank the Minister for that comprehensive answer. I also thank all the House for its supportive remarks on this amendment.
I say to my noble friend Lord Adonis that the two things we are talking about—the accountability of Parliament and our need to monitor these things, and the voice of the users and people at the receiving end of care, or non-care—are not in conflict. We need to be doing both, of course.
The noble Baroness, Lady Hussein-Ece, was quite right to point to vulnerable children and their care. My noble friends Lord Hain and Lord Blunkett were also absolutely correct about the importance of civil society in getting us through this crisis.
My noble friend Lady Pitkeathley is not here, but she is listening to us. She texted me to say, “Thank you for mentioning carers”. Of course in all this, the carers —people who are at home, many of them quite elderly themselves—are caring for people who will be at the sharp end of what comes next. We should not forget that.
I found two things very useful. First, the noble Lord, Lord Russell, mentioned the NCVO’s role in this, and he is absolutely right. Secondly, and finally, the Minister mentioned that the Government will produce guidance on the enactment of these clauses. This has to be done quickly but I put in a plea: that the voices we have talked about in this short but pertinent debate should be heard in the construction of that guidance, too. On that basis, I am happy to withdraw my amendment.
My Lords, I attempted to put my name to this amendment. For some reason, presumably because the Public Bill Office staff are all working from home, it did not quite get through. The Government need to give this very serious consideration indeed.
My Lords, I completely recognise the good intentions of this amendment and the desire to protect women in an awkward situation at a difficult time. I also recognise the strong stakeholder views given to me by the royal college, Marie Stopes and others, but it is the Government’s priority to ensure that women who require abortion services should have safe, high-quality care and that abortions should be performed under the legal framework already set out by the Abortion Act.
It is vital that everyone, regardless of their views on abortion, be assured that this Bill’s provisions work alongside existing priorities of legislation, including abortion legislation. As I have described a number of times from this Dispatch Box, the powers in this Bill are solely and entirely to meet the needs of tackling this current pandemic. It is in that spirit that the Bill has moved so quickly through the House and that we have had such strong multi-party support for it.
The safety of women remains our priority, but it is vital that appropriate checks and balances remain in place regarding abortion services, even while we are managing a very difficult situation such as Covid-19. We have worked hard with abortion providers, including the Royal College of Obstetricians, and listened to their concerns, but there are long-established arrangements in place for doctors to certify and perform abortions, and they are there for good reason. We do not think that it is right that midwives and nurses are suddenly expected to take on expanded roles without prior consultation, proper training or guidance in place.
The coronavirus outbreak is a global issue. We are not the only country having to make difficult and uncomfortable changes. All over the world, clinicians and service users are coming to terms with extremely difficult workloads and workarounds to normal procedures. We are doing an enormous amount to help the NHS cope. We are doing this to protect life and to protect the NHS, but we expect doctors to work flexibly during this time. That means that certification can still take place in a timely way. It should not delay women receiving treatment. There is no statutory requirement for either doctor to have seen or examined the woman, as I described at Second Reading yesterday. Assessment can take place via telemedicine, webcam or telephone. Guidance from my department is crystal clear about that. The doctor can also rely on information gathered from other members of their multidisciplinary team in reaching a good-faith opinion. However, we do not agree that women should be able to take both treatments for medical abortion at home. We believe that it is an essential safeguard that a woman attends a clinic, to ensure that she has an opportunity to be seen alone and to ensure that there are no issues.
Do we really want to support an amendment that could remove the only opportunity many women have, often at a most vulnerable stage, to speak confidentially and one-to-one with a doctor about their concerns on abortion and about what the alternatives might be? The bottom line is that, if there is an abusive relationship and no legal requirement for a doctor’s involvement, it is far more likely that a vulnerable woman could be pressured into have an abortion by an abusive partner.
We have been clear that measures included in this Bill should have the widespread support of the House. While I recognise that this amendment has some profound support, that the testimony of the noble Baroness, Lady Bennett, was moving and heartfelt, and that the story of her witness from Lincolnshire was an extremely moving one, there is no consensus on this amendment and the support is not widespread. Abortion is an issue on which many people have very strong beliefs. I have been petitioned heavily and persuasively on this point. This Bill is not the right vehicle for a fundamental change in the law. It is not right to rush through this type of change in a sensitive area such as abortion without adequate parliamentary scrutiny. For example, there has been widespread support for measures such as permitting cremations to proceed on the basis of only one medical certificate. We simply do not have the same widespread support to make similar recommendations on the certification of abortions. For that reason, I urge the noble Baroness to withdraw the amendment.
(4 years, 8 months ago)
Lords ChamberMy Lords, I offer profound thanks to all concerned. I thank the Bill team, who have put together a balanced, thoughtful Bill in an amazingly fast turnaround. I thank my own team at the Department of Health for their enormous support. I thank the team in the Leader’s office and Whips Office who have worked to manage a remarkable programme in order to pass the Bill. I thank those in other parties who have worked in a collaborative, positive and supportive way during the whole process. I thank those who work in Parliament and in the House of Lords who are here today at considerable risk to themselves; they have displayed amazing commitment to this remarkable organisation by being here. I beg to move.
My Lords, on behalf of these Benches, I thank the Minister for the way he has conducted the Bill. It has been a perfect exercise in consultation and work across the House. I thank not just the parties but other noble Lords who have taken part in this Bill for co-operating and working together in a way that has allowed us to scrutinise it as best we possibly could. I think we raised every issue that we could during its passage. It is important to have those things on the record because, as we move forward, we will need to know that we have asked those questions, and the Government will need to address them.
I thank my team, particularly my noble and learned friend Lord Falconer, who got drawn into this about a week ago, and my noble friend Lady Wheeler. I also thank the people in the office, who of course do all the work. In our case, that is Rhian Copple, who has done a brilliant job in keeping us informed and on the go.
I thank all my noble friends and noble Lords who are not here, but who gave us their views and have been patient. I know that they would have wanted to be here.
(4 years, 8 months ago)
Lords ChamberTo ask Her Majesty’s Government, in the light of Northwick Park Hospital’s declaration of a “critical incident” and an increasing number of patients across the UK with Covid-19, what steps are they taking to increase critical care capacity in the NHS.
My Lords, Covid-19 is the major challenge of our generation. This Government’s priority is to protect life, which is why we are taking urgent action significantly to increase care-bed capacity throughout the NHS, including freeing up almost a third of existing beds. Yesterday, the Government announced a major deal with independent hospitals. That will add to the NHS’s pandemic response 8,000 hospital beds, 1,200 more ventilators and a significant front-line staff number of 10,000 nurses, 700 doctors and 8,000 other clinical staff.
I thank the Minister for that Answer. It is of course incredibly worrying that, at this stage in the pandemic, Northwick Park Hospital was forced to declare a critical incident over the weekend. That means that it ran out of critical care beds and had to ask neighbouring hospitals to take its Covid-19 patients. It is likely to be two weeks before we may see a steadying of the spread as a result of social distancing measures. If one hospital is already finding itself in such a position, then more might do so in the coming weeks and months. As the Minister said, it is urgent to expand capacity by increasing the number of intensive care beds and ventilators available. Will the Minister detail how many ICU beds and ventilators the Government aim to have in place by the end of the two-week period, at which we hope infection rates will reflect the new measures?
Also, the House may be aware that a fit and healthy 36 year-old nurse is now on a ventilator in Walsall Manor Hospital, having contracted Covid-19. Are the Government confident that the supply of personal protective equipment is no longer an issue after an increase in delivery in recent days and that there are plans to further increase the production of such equipment?
My Lords, the decision by Northwick Park was entirely welcome, because we welcome the realism and practicality on the part of the management in seeking help when it is needed. We are moving at pace to address the issues around PPE, and I can confirm that there is a massive amount going into the system as we speak. We currently have 3,700 critical care beds; total usage is currently 2,428, of which 237 are Covid-19 related; and our ambition is to increase this dramatically to perhaps 30,000 in time for the crisis arriving in full.
(4 years, 8 months ago)
Lords ChamberThe noble Lord, Lord Alderdice, is entirely right: one of the features of this virus is its extremely unpredictable nature. The way in which it reacts in different people at different times is extraordinarily diverse. Some people appear to be completely knocked out by it; some have the lightest possible symptoms. There seems to be an alignment with age. We are all enormously thankful that the young and very young seem to be blessed by having the light symptoms. We are all extremely concerned about the old, but it is not even as simple or as linear as that. A huge investment is being put into understanding the virus better. I am pleased to report to the Chamber that international co-operation on that is extensive and positive, and that British researchers are at the leading edge of pulling together that data.
My Lords, this is a question on co-ordination. Yesterday, I saw the script that 111 is using right now; it was perfectly intelligible and sensible. However, it was out of step with what was on Public Health England’s website. I am sure that is a timing issue but it is rather important, because it will increase anxiety. Moreover, the digital exclusion of the elderly and vulnerable is a really serious problem because suggesting to people that they should go online in the first instance is entirely inappropriate for people who can manage a phone, but that is about it. Many of us are probably related to people in that position, so having plans to deal with that—as suggested by the noble Baroness, Lady Watkins—is very important.
The noble Baroness, Lady Thornton, is right that the Government have moved incredibly quickly, particularly in the last two weeks. The pace of the virus has been faster than initially expected. The response by some of our international partners has in part conditioned our response, and we are working extremely hard to ensure that all parts of the machine keep up with each other. There will inevitably be occasional glitches, but I pay tribute to the NHS, Public Health England and, in fact, the entire Whitehall machine for moving incredibly quickly and, under the circumstances, demonstrating a relatively high level of consistency in the advice as policy has changed.
(4 years, 8 months ago)
Lords ChamberTo ask Her Majesty’s Government what assessment they have made of the shortage of supply of (1) contraceptives, and (2) hormone replacement therapy drugs, in the United Kingdom, and when they expect that the normal supply of these products will resume.
My Lords, we are aware of ongoing supply issues with some HRT drugs and a limited number of contraceptives. We are sympathetic to those affected. I am pleased to say that the supply situation for HRT started to improve at the end of February and continues to improve during this time. However, we will work closely with all suppliers and share relevant information on availability to the NHS on a regular basis to ensure that patients can access the medicines they need.
I thank the Minister for that Answer. I am very happy that things are improving, because a number of HRT medications and contraceptives remain unavailable until the end of this year, some patients have been told, or until they do not know when. I understand that some of the shortages are triggered by supply problems in China, with some of the components of the popular HRT patches being increasingly in demand for other types of treatment that, in their turn, have become scarce. Of course, one guesses that further disruption in China in the wake of the coronavirus will affect the production and supply of prescription drugs. Does the Minister share my concern that online pharmacies are exploiting desperate women by charging up to four times NHS prices for HRT and contraception?
The noble Baroness, Lady Thornton, is entirely right that supply problems persist. The NHS looks after 11,000 drugs and at any one time around 100 or 150 have supply problems. It is a great frustration to those concerned and we are cognisant that HRT has been a persistent problem for more than a year. However, the outlook is positive. I reassure the House that Covid-19 has not had an impact on the supply of HRT. We do not envisage there being a connection or a problem. I share the noble Baroness’s concerns that online pharmacies might take advantage of the situation, but it is a marketplace: it provides choice and is regulated.
(4 years, 8 months ago)
Lords ChamberMy Lords, I thank the Minister for repeating the Statement. I shall ask three questions as quickly as I can so that as many people as possible can get in to speak.
My first question concerns vulnerable people in residential homes and the learning disabled who may be being supported, either by charities or at home by their parents. We need to include these people in the planning. I do not expect the Minister to respond to the point, but I will put it on the table. There are lots of people who have not been mentioned but need to be taken into account.
The 111 service is clearly under incredible pressure, given that it apparently took 120,000 calls in the first week of March. I want to ask the noble Lord about the training that 111 staff are receiving. If 700 new people have been taken on, how is their training being accelerated and is it being properly funded?
Finally, when the Select Committee saw Professor Whitty last week, he explained that half of all coronavirus cases in the UK are most likely to occur in just a three-week period. Based on recent trends, have the Government estimated when that peak might begin, and is the noble Lord sure that hospitals have enough bed spaces so that they are able to cope?
My Lords, the noble Baroness has expressed concerns about those in residential homes and people with learning difficulties. The needs of all the most vulnerable in society are paramount. There is no doubt that intense pressure will be put on social services, social care and clinical care. We are doing all we can to ensure that support is in place, which will include the mobilisation of civil society, charities and volunteers to take up some of the pressure being put on those services.
On training provision, modern call centres have very flexible working arrangements whereby staff are brought on and off contracts. Those who have already received 111 training are being brought back on to the front line. The funds for that are properly in place.
On the timing of the peak, it is impossible to say with certainty when that will be, but the CMO is crystal clear: we will do everything we can to spread it out over the summer and we will keep this House and the public up to date.
(4 years, 8 months ago)
Grand CommitteeThe noble Lord, Lord Campbell-Savours, is entirely right to press me on this. I should be honest: obviously, I am not a doctor. However, we have arranged for another briefing from the Chief Medical Officer in Room G at 4 pm tomorrow. He is the epidemiologist who can convey to the noble Lord both the extent and limits of current understanding of the virus. I have sat with him sufficiently long to have the impression that a lot of speculation, guidelines and history are associated with such viruses that we might reasonably apply to this one. However, its behaviours are not fully understood. Although the genome is broken, we do not fully understand its genetic makeup. The advice from the CMO generally is to hold back on pretending to understand things that are not yet fully explored.
I say to my noble friend that I would not use the internet as my source of information on any of these issues. I would use the BBC, which has been running extra programmes—in fact, I have just received an email from the head of the World Service listing all the extra programmes that the BBC is producing which will give us lots of advice. Its website is useful. I want to put it on the record to my noble friend that I would steer clear of those sorts of discussions on the internet and look at the BBC’s websites.
My Lords, the Minister’s Answer gives me great optimism because it seems from the report by the Women and Equalities Select Committee in the Commons that there is an LGBT action plan on which the Government Equalities Office has the lead and which covers LGBT-inclusive healthcare, but it is separate from and not included in the NHS long-term plan. I think the Minister would agree with me that this is unhelpful. It seems to imply that the responsibility for LGBT-inclusive healthcare lies with the Government Equalities Office rather than with health and social care institutions. Will the Minister look into this and perhaps write to me about whether it is a good idea that this is the case, and perhaps suggest a solution to it?
I assure the noble Baroness that the LGBT action plan, which is, as she described, a detailed programme to address these issues, is delivered by Dr Michael Brady, the national LGBT health adviser, who works very closely with the NHS. LGBT issues are at the centre of the long-term health plan and will remain so.
The culture of the NHS and the well-being of those who work in it are of paramount importance. Getting that right is the focus of the NHS people plan. Working with the GMC on all these arrangements is a priority for the Government and I would be glad to follow up my noble friend’s suggestion.
My Lords, I thank the noble Lord for organising the meeting that we have all just come from; everybody there very much appreciated it. I am sure he agrees that seeing so many doctors leave the NHS in the early stages of their careers is very worrying. Indeed, it will worsen the recruitment crisis that we are seeing. What steps are the Government taking to understand the driving forces of and the motivating factors for the exodus from the UK’s medical training programmes? Have the Government committed to collecting that information from doctors who have left? Understanding that must support strategies for getting them back in again.
The noble Baroness makes an important and fair point. Understanding why people depart is very important. Departure rates are too high for us to hit our objectives and raising retention rates is important. However, I emphasise that the leaver rate has not increased as she implies. In 2014 the rate was 14% and in 2018 it was 15%. That is not a huge increase but it is too high and we are finding ways to address it.
My Lords, I completely commend the work of The State of the Nation report by the Terrence Higgins Trust, which the noble Lord was greatly involved with. It points to a serious situation in the nation’s sexual health, but one that the Government take very seriously indeed. It is worth mentioning that consultations at sexual health services between 2014 and 2018 increased by 15%—from 3.1 million to 3.5 million. This has been in part through the use of new technology such as online testing services and delivery kits, which have proved to open up sexual testing to audiences who find attendance at GUM clinics awkward and embarrassing. However, his point on the sexual health strategy is well made. The Government are focused on delivering this strategy at the soonest possible moment. Engagement is ongoing, and as soon as that is wound up the strategy will be published.
My Lords, can I say how much I will miss the noble Baroness, Lady Blackwood, and how much I enjoyed working opposite her? Notwithstanding the noble Lord’s obvious talents, I hope that the Government will find time to appoint a Minister for the health service in this House. May I say how much I agree with the report by the Terrence Higgins Trust, The State of the Nation? Will the noble Lord comment on the lamentable statistics showing a 26% increase in gonorrhoea cases and the highest number of syphilis cases since World War II, which could be to do with the fact that since 2014 sexual health services have been cut by a quarter? When will that be restored?
The specific example cited by my noble friend is not one that I am able to comment on, but she raises an important question about resources for paediatric care. This Government are putting considerable resources into both capital and spending. Paediatric care is prioritised over other areas of care and we take this matter very seriously.
My Lords, I go back to what the Minister said in response to my noble friend. It sounded to me as if he was suggesting that the faculties and Royal Colleges had somehow falsified figures. That is a very serious accusation so I would like him to clarify that and, if that is what the Government think, what they are going to do about it.
Secondly, one of the reasons for the pressure on beds is staff shortages; many units were limiting the number of patients that they could treat to fewer than their physical bed space. Does the Minister recognise that dilemma, and what action are the Government taking urgently to address the workforce crisis in paediatric medicine?
The noble Baroness asked about the statistics. The anecdotes put forward by the Faculty of Intensive Care Medicine and the president of the Paediatric Intensive Care Society are perfectly valid. They are reasonable stories. The question put was about whether NHS statistics are being falsified. These are very serious suggestions and questions. I reassure the House that the statistics put together by the NHS are blue-chip and very much ones that we are proud of.
(4 years, 10 months ago)
Lords ChamberTo ask Her Majesty’s Government whether they plan to ban repair of hymen surgery.
My Lords, no one should undergo any surgical procedure that they do not want or need. Pressuring a female partner or family member into having an unnecessary surgical procedure is never acceptable. The Government are investigating hymen repair surgery, and we will take all necessary action to ensure that all vulnerable women and girls are protected.
I thank the Minister for his reply. As noble Lords will have gathered, hymenoplasty is the so-called restoration of virginity, and it is not illegal in the UK. It is carried out in private clinics, by and large, and apparently costs about £3,000 a go. The Sunday Times revealed that NHS facilities were used to carry out this procedure 82 times in the past eight years. The noble Lord is quite right: clinicians agree that there is no medical reason for the restoration of the hymen, so why is that procedure available on the NHS? No explanation was given to the Sunday Times when it asked why the procedure was delivered. I think the noble Lord and I would agree that the NHS should not be offering a procedure designed to perpetuate harmful myths about virginity and threats to vulnerable women and girls.
The noble Baroness is absolutely right about harmful myths. The Government are deeply concerned about the climate in which this industry is operating. We will be looking into how the frameworks are being applied by the GMC, the CQC and the ASA. On her specific question about the NHS, there were around 82 cases according to the records available. Very sadly, there are cases of abuse and rape—and, I am afraid, of fear of death—that may, even with the best counselling available, give a young woman or girl a good reason to ask for this procedure. It is under such circumstances that the NHS provision has been made.
My Lords, I beg leave to ask the Question standing in my name on the Order Paper. In doing so, I declare my interests as set out in the register.
NHS England and partners commissioned an evaluation report of Babylon GP at hand. This was published in May 2019 and concluded that, overall, users are satisfied with the service, in particular its convenience. The GP at hand work- force demonstrated high satisfaction with the service, particularly with the flexible work arrangements. However, satisfaction was lower for waiting times for face-to-face appointments. Practice funding is being revised to improve fairness following the emergence of digital- first providers.
I am not sure how many noble Lords realise what GP at hand is. It is a virtual GP app that uses artificial intelligence to identify health problems and has a partnership with the NHS in London and Birmingham, where patients can sign up for the digital-first GP at hand service and receive video consultations. I am absolutely in favour of the use of new technology in primary healthcare—this is not a Luddite Question—but clinical commissioning groups in London have, on the instructions of NHS England, had to reserve large sums of money, of up to £1 million, in their 2019-20 budgets for the next year to meet the costs of Babylon GP at hand. They have not commissioned this work; it is not included in the safeguarding or quality oversight of them; and it is paid for without basic information about how many or which patients are leaving local GP lists or the impact that this might have. Does the Minister think that this is a satisfactory situation, in terms of the control and accountability of local budgets? Would the money, which I understand stands in London at about a £21 million deficit, not be better spent providing technology and IT infrastructure for the use of our GPs in their surgeries?
The noble Baroness raises an important question. The Government are aware of the issues faced by out-of-area commissioning, and particularly of the concerns of Hammersmith and Fulham Council. We are looking at its concerns about its budget provisioning. We do not recognise all the numbers, but we are trying to understand them better. I reassure her, however, that we are putting in measures to ameliorate the situation. We are looking at ways to disaggregate a patient list if there are large numbers of digital-first patients; we are making more timely adjustments to CCG budgets, moving to quarterly rather than annual assessments; and we are looking at how to apply technology to under-doctored areas.
To ask Her Majesty’s Government what steps they are taking to safeguard the supply of medicines and medical devices in the event of a no-deal Brexit.
My Lords, the Department for Health and Social Care is doing everything possible to prepare for an exit from the European Union, whatever the circumstances. We have worked with trade bodies, product suppliers and the health and care system throughout the UK and have made great progress towards ensuring continuity of supply to the whole of the UK and its Crown dependencies. I reassure patients that our plans to ensure the uninterrupted supply of medicines and medical products when we leave the EU are as solid as possible.
I thank the Minister for his Answer. This Question was prompted by the National Audit Office report published last week, which justified considerable concern among NHS workers and patients about the availability of basic medicines if the UK crashes out of the European Union.
I wish to raise two specific concerns with the Minister. It seems likely that the availability of the flu vaccine will be affected by a no-deal exit. Andrew Goddard, the president of the Royal College of Physicians, said:
“I can’t … say, ‘Don’t worry, no deal will be fine, no one is going to come to any harm, no one is going to run out of medicines.’ What we can see is we’re likely to not have enough flu vaccine … and that is likely to have an impact on the NHS”.
So will the Minister inform the House whether the department has a plan to deal with this eventuality and, if so, what it is? Secondly, what is the plan for the availability of medicines and treatments that cannot be stockpiled, such as isotopes, which are vital for cancer treatment and which by definition have a short shelf life?
To ask Her Majesty’s Government what assessment they have made of the compatibility of their recent campaign advertising the return of duty-free shopping after Brexit with (1) domestic law and (2) international charters governing the advertising of tobacco products.
My Lords, the recent announcement provides clarity for consumers on the application of duty-free in the event of a no-deal Brexit. It allows businesses and port and airport operators time to prepare. This is a temporary policy only that complies with international laws by broadly treating all individuals in a similar way while aiming to ensure that individuals can continue to cross the border without undue disruption or delay. The Government commit to consulting on a longer-term approach.
I thank the noble Lord, Lord Bethell, and welcome him to his brief—whether it will be a permanent or a temporary occupation of it. I suspect that we will be seeing quite a lot of each other this afternoon. The Chancellor said:
“As we prepare to leave the EU, I’m pleased to be able to back British travellers. We want people to enjoy their hard-earned holidays and this decision will help holidaymakers’ cash go a little bit further”.
Fine. I reassure noble Lords that this is not about alcohol but about tobacco. Accompanying this, information was posted on the Government Brexit website and shown on main television channels containing information about purchasing duty-free tobacco without duty. The law in the UK is quite clear:
“A person who in the course of business publishes a tobacco advertisement, or causes one to be published, in the UK is guilty of an offence”.
So my question to the Minister, which he has not answered, is whether the Government have strayed outside our tobacco regulations and law. Another question I need to ask is whether this is a sign that the Government intend to use Brexit as a way of undermining or relaxing the UK’s legal and regulatory position on tobacco regulation.
Perhaps I may remind the House that we are talking about a tweet from Her Majesty’s Treasury’s on its Twitter feed: it was not a paid-for promotion in any way. The advertising authority reviewed the tweet and confirmed:
“It was posted in non-paid for space, (i.e. their own Twitter account) and features no direct encouragement for consumers to buy or do anything, so it falls outside our rules”.
This Government are fully committed to our health policy on tobacco and to bringing down tobacco smoking and consumption in this country. However, a no-deal Brexit creates ambiguity both for shop owners in airports and ports and for consumers, so this was a perfectly reasonable move to bring clarity to a confusing area of policy.
My Lords, I am confident that all noble Lords have a shared intention to protect and improve the safety of patients using medicines, while enabling their access to the most innovative treatments. As my noble friend Lady Manzoor stated previously:
“Our regulator, the Medicines and Healthcare products Regulatory Agency, MHRA, has over 30 years’ experience as a leading regulator in the EU. This expertise and experience is globally recognised and respected; we want to ensure that this continues, to the benefit of UK patients. It is with this at the forefront of our minds that the UK’s plans for the regulation of medicines … in a no-deal scenario have been developed”.
As my noble friend set out on 7 March 2019, it is important to reiterate our aim to retain a recognised regulatory system, which ensures that,
“patients in the UK and the EU continue to have timely access to safe and effective medicines”.—[Official Report, 7/3/19; col. 758.]
The system for regulating medicines is currently set out in EU legislation, and we have made legislation to ensure that our national regulatory system continues to function without any detriment to our ability to protect the public health in the event of the UK leaving the EU without a deal. We will then be considered a third country by the EU and, in this scenario, the UK regulator will take on the functions currently carried out by the EU. Additional changes are now being made through the SI in areas the Department of Health and Social Care has identified would benefit from further clarification. This is being done in response to comments from stakeholders, including industry and the life sciences sectors, and from internal review.
The changes proposed do not in any way represent changes in any underlying policy; rather, they are technical in nature, correcting minor drafting errors and omissions, and seek to ensure only that the original policy intention is delivered in legislation. The amendments proposed by this SI continue to be based on the department’s priority to ensure timely availability of safe, effective medicines and medical devices, while minimising disruption to patients and businesses, and to ensure that the regulator can continue to protect public health.
Noble Lords will note that the original regulations were developed through close consultation and co-operation with stakeholders, and that the department has published an impact assessment. After a period of informal consultation in August last year, the MHRA published an initial proposal for the UK’s medicines regulation framework and followed this up through a four-week public consultation in October. The feedback from that consultation—which received about 170 responses—led to revised proposals, which were published in January, and informed the development of the system that will come into place in the event of no deal. Noble Lords will have seen the published impact assessment, which was developed by experts at the MHRA and influenced by responses to the consultation. Noble Lords will want to be reassured that none of the proposed amendments change this impact assessment.
I will now give some specific detail of the arrangements set out in this SI. The majority of the changes being made are technical in nature and have arisen as we have reviewed the legislation and identified areas requiring changes to the legal text to ensure that it gives effect to the published policy. There are no new policy changes introduced in this SI.
This SI makes the following amendments for medicines specifically. First, it makes clear the requirements for a responsible person for import and RPI and for a wholesaler’s licence to hospitals importing human medicines directly from a country on an approved list for their own use. Secondly, it clarifies that UK generic applications can rely on data supplied in relation to medicinal products whose EU marketing authorisations were cancelled pre-exit on grounds other than safety, quality and efficacy. Thirdly, it gives additional detail in relation to the process by which companies may make representations to the Commission on Human Medicines about decisions on rare disease medicines and paediatric matters. Fourthly, it provides for a temporary exemption, subject to a specified condition, from the obligation to maintain a UK pharmacovigilance system master file for companies whose UK authorisations are included in an EU file. This also includes the condition that information required by the licensing authority be provided by the marketing authorisation holders on request. Fifthly, it clarifies that the temporary exemption as to the geographical location of an appropriately qualified person for pharmacovigilance applies to all marketing authorisations and herbal registrations that a company holds, whether granted before or after exit day. This is provided that they are covered by a single pharmacovigilance system in respect of which there is the same qualified person. Lastly, it adds the Republic of Korea to the approved list of countries with equivalent regulatory standards for the manufacturing of active substances on exit day. This is to reflect the updates to the EU list since the no deal SI was made.
For medical devices, there are some changes resulting from amendments made by the EU to the underlying medical devices regulations since the no-deal SI was made via the recently published corrigendum. The changes range from grammatical and reference corrections to a change concerning what is included in the transitional arrangements. Two further changes are inserted to ensure that products mainly used for cosmetic purposes are required to comply with common specifications and to require the information registered with the MHRA about medical devices to be updated by the manufacturer.
In conclusion, in the event of no deal these regulations will put in place technical changes that will ensure that the UK’s medicines regulations legislation continues to function effectively after exit day. These provisions will minimise any impact on patients and businesses and will ensure the timely availability of safe, effective medicines in the UK market.
I thank the Minister and welcome him to the world of EU health statutory instruments and their amendments—whether it is just for today or for a longer period. I also thank him for his explanation. I really hope that the Government have managed to get it right this time—I am not quite sure whether I have visited this twice or three times in the last year or so.
This statutory instrument comes into force immediately before exit day to correct the defects and omissions in the Human Medicines (Amendment) Regulations 2019 and the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019. They come into force on exit day and, as the Minister described, amend our various regulations to ensure that they are fit for purpose in the case of the UK crashing out of the European Union without a deal.
As noble Lords know, EU law provides that the EU medicines regulatory system—of which the UK is currently a part—ensures, for example, the recognition of prescriptions across the EU and EEA, provides for the monitoring of the safety of medicines and incentivises the development of medicines to treat rare diseases and children. EU law also provides for an EU regulatory system for medical devices and in vitro diagnostic devices. This provides a conformity and safety before these things can be placed on the European Union market—so they are very important.
I have a few questions. First, it is said:
“The new Medical Devices Regulations … and in-vitro Diagnostics Regulations … have been applied directly in UK law since May 2017 and will be fully implemented in the EU from May 2020 and May 2022 respectively”.
So my question is: what is happening to them in the meantime? If we leave the European Union in six weeks’ time, will these things still be implemented or not? I just want to know whether my reading of that—from the Explanatory Notes in this case—is right.