My Lords, the statutory instrument that we are discussing today relates to the regulations for medical devices within Northern Ireland. It reflects the application of EU regulation 2017/745 on medical devices, which I will hereafter refer to as the EU medical devices regulation, under the terms of the Northern Ireland protocol. As noble Lords will be aware, the protocol agrees to continue applying certain EU rules in Northern Ireland to recognise the unique status of Northern Ireland within the UK and to uphold the Belfast/Good Friday agreement. It is important to remember that this instrument does not apply the EU medical devices regulation within Northern Ireland. That legislation took automatic effect in Northern Ireland from 26 May this year, under the terms of the Northern Ireland protocol.
The EU medical devices regulation contains some flexibility areas, where states have the discretion to make policy decisions and adjustments. This instrument therefore makes provisions to apply in Northern Ireland where it serves to align Northern Ireland policy with Great Britain. This is to deliver the Government’s commitment to the pragmatic implementation of the Northern Ireland protocol. In creating the provisions in this instrument, we are minimising the impact on economic operators and the public in Northern Ireland, as the Northern Ireland protocol pledges.
The Medical Devices Regulations 2002, hereafter referred to as the 2002 regulations, will continue to be the relevant regulations for in vitro diagnostics in Northern Ireland, and will operate alongside the EU medical devices regulation and this instrument on the regulation of medical devices and active implantable medical devices.
I shall give some background. This instrument achieves the Government’s commitment to align Northern Ireland with Great Britain, where permitted, in four areas. First, it implements national adjustments for Northern Ireland in areas where the EU medical devices regulation grants member states the ability to make national policy decisions. This has been done in a way that will align with policies in place in Great Britain. Secondly, it sets out the fee structures that keep fees aligned with those applied in Great Britain. Thirdly, it sets out the enforcement regime for activity and violations under the EU medical devices regulation in Northern Ireland. Lastly, it makes amendments to existing regulations, to take account of the application of the EU medical devices regulation in Northern Ireland.
I will first describe areas of national flexibility where this instrument makes provision to change default positions under the EU medical devices regulation to maintain Northern Ireland policy with that of Great Britain. The Government currently permit the remanufacturing of single-use devices, which the EU refers to as reprocessing, so long as the remanufacturer adheres to strict requirements. The default position of the EU medical devices regulation is not to permit remanufacturing unless there is national legislation in place to support it. This instrument does just that. This means that the remanufacturing of single-use devices can continue to take place in Northern Ireland, as well as in Great Britain, so long as requirements under the relevant legislation are followed.
The instrument also introduces provisions so that the MHRA can continue requiring custom-made devices, ranging from dental appliances to orthopaedic moulds, to be registered before being placed on the Northern Ireland market. Provisions are also contained in this instrument that uphold our national requirements for clinical investigations, which are crucial for ensuring that the safety of participants is protected. They do so by maintaining the MHRA’s ability to authorise clinical investigations for all risk classes of medical devices before they can commence. Furthermore, it upholds the requirement for all clinical investigations for custom-made devices to be subject to MHRA assessment. The Government remain committed to delivering improvements to patient safety, and this instrument means that we can respond proactively to any concerns.
By amending the Consumer Rights Act 2015 and the Medicines and Medical Devices Act 2021, this instrument provides the MHRA and district councils in Northern Ireland with inspection powers and powers to serve enforcement notices for breaches of the EU medical devices regulation within Northern Ireland. This will ensure that the MHRA has the enforcement powers it needs to ensure patient safety is prioritised and high standards are maintained for the people of Northern Ireland.
The MHRA charges fees to cover the costs associated with certain aspects of the regulation of medical devices. This instrument details fees which may be charged for activity under the EU medical devices regulation in Northern Ireland, keeping them identical to those charged in Great Britain under the 2002 regulations for similar services. This upholds the Government’s commitment to ensure that there are no disadvantages to economic operators in Northern Ireland as a result of the Northern Ireland protocol. This instrument does not introduce any fees for new requirements under the EU medical devices regulation.
Finally, this instrument makes technical amendments to other legislation, including the 2002 regulations, to reflect the application of the EU medical devices regulation within Northern Ireland. This will ensure the regulatory landscape operates effectively in Northern Ireland. Officials in the Northern Ireland Executive have been kept informed of the progress of this instrument and I am hugely grateful for their continued collaborative approach. As the nature of the changes in this instrument are technical in many instances, the impacts of the instrument do not meet the threshold for impact assessments, hence these are not provided.
In conclusion, this instrument upholds the Prime Minister’s commitment to the Northern Ireland protocol and to minimise the impact on the activities of economic operators and the public in Northern Ireland. The significance of our public healthcare system has never been clearer than during the Covid-19 outbreak, and this instrument will ensure that the UK’s exceptional standards of safety are maintained within Northern Ireland. This is something we must support. I commend the regulations to the Committee.
My Lords, as there are more than half a million of these devices on the market, it is understandable that effective regulation should be in place and workable. It is also clear that most of us will need one of these devices at some time in our life. It is to be hoped that these regulations will give patients more information and choice, and that they will benefit from more up-to-date therapies. I ask the Minister this: what will be the effective way of seeking expert opinions on the wisdom of a proposed new operation that does not necessarily involve a medical device? It would be helpful to have a second opinion on whether it is likely to be feasible and safe.
As there are often notoriously long delays in obtaining answers from official bodies, and we are talking about regulations now, has any thought been given to placing a regulation to require answers within a certain time?
There has been discussion about a robust financial compensation mechanism to ensure that patients are dealt with fairly and justly for the damage caused by defective devices and by their inappropriate use in certain parts of the body. For instance, the mesh which caused so much damage in operations for incontinence is used widely and safely in hernia operations. Could the Minister tell the Committee who will operate these compensation mechanisms? Who will decide whether compensation is justified and how much to award?
My Lords, following on from the speech of the noble Lord, Lord Rooker, and particularly referring to the Secondary Legislation Scrutiny Committee, I shall cover a number of additional points that the committee raised and seek the Minister’s advice on them.
These are welcome regulations providing rigorous quality approval processes for all Covid-19 tests sold in the United Kingdom. It is essential that tests currently sold outside the NHS do not lead to an unregulated black market developing. As we emerge from the lockdown phase and work towards a more open market based on personal responsibility and extensive, easily available testing, confidence, clarity and a strong legal framework need to be the guidelines for all such products.
I have a number of questions for my noble friend the Minister in this context. Are the proposed minimum standards to be employed exactly the same as the standards already in place for tests used by the NHS? If not, will he set out the differences? Will the proposed mandatory processes be clear and well publicised for manufacturers of molecular and antigen tests? In particular, I am interested in the process envisaged for PCR tests since it focuses on genetic material—RNA—and is new in the mainstream pharmaceutical market. In this context, is it envisaged to widen all testing on RNA-based vaccines and medications? This area of medicine impinges on major ethical issues in an area of science that is gathering pace and that many see to have advanced 10 years or more as a result of the substantial investment made in RNA-based vaccines and medicines during the Covid period.
I invite my noble friend to follow up on the intervention by the noble Lord, Lord Rooker, regarding addressing the problems with the accuracy of lateral flow tests. They are disturbing and have rocked public confidence, with 75% not meeting the performance and quality standards of the NHS tests. If we want public support for test and trace, the whole edifice of confidence collapses if there is no confidence in the accuracy of the market-based tests whose failure in turn blurs, and indeed damages, confidence in NHS tests.
Like other noble Lords, I think timing is important. It is difficult to read these regulations and believe them to be, as described, “rapid”. As I understand the position, existing tests will continue to be available in the UK market and will be required to submit their application only by 1 September. The validation process will then have to be completed by 31 October for them to remain on the market on 1 November. That means that potentially substandard products can continue to be supplied to the market for another three months or more before these regulations take effect. It is regrettable that this approach was not considered a year ago, or very early this year at least.
Can the Minister provide an update on the recruitment process required to put the DHSC validation team on a more suitable long-term footing? When do we anticipate that it will be completed? Is £6,200 sufficient to cover the proposed costs? How many applications do the Government expect as a result of these regulations?
In closing, I note that local authority trading standards are being asked to ensure that unapproved tests are removed from sale. From my experience of the Consumer Protection Act and the many hours of debate on subsequent consumer protection legislation—as applicable to, in my case, the secondary ticket market, which trading standards are being asked to oversee—I know that one of the consistent calls from all sides of the House is to increase resources to trading standards. Trading standards are constantly subject to a regular flow of additional responsibilities generated by legislative action taken in Parliament. Is it the Government’s intention to ensure that any additional resources for these purposes will be made immediately available to trading standards? If so, what do they estimate these to be?
My Lords, I am grateful to my noble friend the Minister for his introduction to these regulations. I agree with the noble Lord, Lord Rooker: my noble friend has acquired a rhetorical flourish or two today.
We can see the powers that we debated on the Medicines and Medical Devices Act coming into use already. The powers in Section 15 are being used for this purpose, but my noble friend will of course recall that Section 16 related to the criteria, including the effect that any regulations made would have on the life sciences industry in the UK. The Explanatory Memorandum argues persuasively that this validation process will increase the resilience of the supply chain and may even encourage domestic suppliers. It also refers to the discount available to SMEs, which is welcome. But paragraph 12.8 of the Explanatory Memorandum says that an impact assessment would be published in time for the parliamentary debate. I could not find one yesterday or today. Will my noble friend say where it is and whether it confirms that it is the Government’s clear view that the life sciences industry and SME interests are fully protected?
There is a clear case for validation of these tests, given the reported failure rates of tests submitted for public procurement, to which my noble friend referred. We need to use lateral flow tests to support the return to school in the autumn, to enable employers to bring their staff back to their workplaces, and to counter outbreaks—in particular with large-scale surge testing—when we have achieved a lower prevalence again, which I hope will be in the late summer.
Studies including the Cochrane review, published in April, suggest that lateral flow tests will reliably confirm that someone without Covid is negative; in that sense, they have very high specificity. Where their sensitivity is concerned, they will confirm infection in someone with symptoms in an average of 72% of cases, but will on average identify the infection in asymptomatic cases only 58% of the time. Those results will vary according to the location and experience of the tester—where it is done and by whom. We need these tests to work at home and not just in the hands of healthcare professionals.
I support the regulations but I have three issues to raise. First, the tests procured by the Government will not be subject to validation because that would essentially be duplicatory, as the test approval is based on that same procurement process. But that procurement process has been used by the Government principally for the procurement of the Innova tests, which, as the noble Lord, Lord Rooker, made clear, are essentially manufactured by Xiamen Biotime Biotechnology in China. The Government, of course, had an intermediary company—Disruptive Nanotechnology, in Northampton—which, as far as I can see, was effectively a non-trading company at the end of December 2019. It is Innova Medical Group that is essentially the intermediary.
Innova is a Californian company. It is reported that it has sold 380 million tests to the Government. But on 10 June, the Food and Drug Administration issued a safety communication that the Innova rapid antigen tests should be withdrawn. Indeed, its communication suggested that the people who had them should simply throw them away. The question I come to is this: if we are confident in the Innova tests, what has been the nature of the discussions we have had with the Food and Drug Administration? My understanding is that, essentially, the Food and Drug Administration took the view that Innova was advertising the tests for use with asymptomatic people, but that they were authorised for use with those who have symptoms and that their sensitivity is greater for those with symptoms. Is that why the FDA issued its class I recall on these tests? That being the case, why did my noble friend say when he introduced the regulations that it is really important that we have tests that work for those who are asymptomatic? These tests are not sufficiently specific for those who are asymptomatic.
I know that it is a legal case, so my noble friend might hide behind his inability to speak about it, but why has Mologic, a Bedford company that has a track record, found it necessary to sue the Government in relation to their validation processes for the public procurement? What does that tell us about the validation they propose to use for this purpose?
I have two very quick other points. To put at rest the mind of the noble Lord, Lord Rooker, could my noble friend update us on the plans announced last month for Innova and Sharp packaging to build a factory in Caerphilly to produce up to a million tests a day, starting in July—this month? It is absolutely right that we should have leading medical technology companies in this country and manufacturing supply alongside them.
Thirdly, to further endorse what the noble Lord, Lord Rooker, said, could my noble friend explain what the Government’s intention is on charging for tests, particularly for employers, who will want to institute testing regimes to bring their staff back into their premises and to protect the public and their customers while doing so? They have had 18 months, in many cases, during which they have lost revenues. Should we really expect them to meet this further cost at this stage? Their taxes will sustain us in the future, but should we not now support them to get back to work? I would be grateful for my noble friend’s response.
My Lords, of course these Benches welcome the general thrust of the regulations—that tests should be safe and that there should be a standard across the UK. However, we also raise the same issue as a number of noble Lords, including the noble Lord, Lord Moynihan, about their timing, and ask why this is emergency legislation. I am afraid it is becoming a bit of a trend that the Government bring things through in emergency legislation. If the instrument had come through a different route in which we had a lot of time, we could have asked many of the questions that we are now asking, and improved and amended the legislation to deal with some of the issues. This is so important, because this is about testing and trying to give the country a sense of what the new normal will be.
The underlying basis of this is a significant change of public health policy. I am not aware of any other infectious disease where public health policy on testing is left purely to the market—unless the Minister can advise otherwise. There is a real issue of this being about not just market failure but the role that public health, public health professions and the public sector will play to ensure that this works.
I say that because, without being linked to the test and trace system, there is a sense that testing in itself will become not as effective as it could be. This SI assumes that public policy will be for most testing to be done outside the NHS, and possibly for a charge. So once these tests are approved and there is a standard, how do mandatory tests then get into the tracing part of test and trace? There is no legislation at present to suggest that has to happen. Employers, or particularly an individual at home, could take a test and it turn out to be positive. Coming back to what has been said many times before in the House and in Grand Committee, if people feel that they cannot afford to self-isolate, they are not going to give details about them being positive.
The question is: if this becomes predominantly a market-driven approach, done by employers and businesses bringing in customers, as the Explanatory Memorandum suggests, or by individuals at home, how does that then trigger tracing? How will it trigger a person having to inform somebody, either locally or nationally, through test and trace, that they are positive? Significantly, how will tracing then kick in to help ensure that the chains of transmission are dealt with as speedily as possible, particularly since evidence suggests that 48 hours is the maximum time before the chain continues to spread?
Regulation 39A says that the Secretary of State can make an exemption for tests coming on to the market which are not tested. In what circumstances does the Minister feel that the Secretary of State would be able to use the power under Regulation 39A? How will it be reported to Parliament or to the public, so that they know whether the test they are getting—or potentially buying—has not been through the statutory testing regime?
I want to further explore something mentioned by the noble Lords, Lord Lansley and Lord Rooker. It is to do with the Innova test and the recommendation in the email from the Food and Drug Administration, which said that this test should be thrown “in the trash”—that was the exact quote. Since it was a class I recall, I need to know what extra testing or analysis has been done by the UK Government based on what they have seen from the FDA and that recall. When was that done and what is the outcome of that testing or analysis, based on the extra evidence that has come from the FDA?
Finally, I would like to ask whether free testing will still be available on the NHS. If it is to be available, a number of questions arise. If I could have free testing on the NHS and it is not means-tested, why would I buy a test, unless certain categories of organisations will not be allowed to use the NHS test? At the moment, people going abroad are not allowed to use the free NHS test. Is it anticipated to be the same for organisations such as businesses—for their staff and for customers coming in, et cetera? What thought has been put into that?
These issues, and the others which noble Lords have raised, are important because this is a matter of public health and of how we contain the virus in the most effective way possible, while keeping people safe. I come back to my opening remark: this is not emergency legislation. It should have been laid normally before Parliament, so that we could have dealt with it and tabled amendments. I would have hoped to make this better, to keep people safe and to deal with proper testing across the UK.
My Lords, I too am enormously grateful for the successful efforts of the noble Lord, Lord Addington, in securing this important and insightful debate. Any debate on our weight, health and fitness is extremely personal and bound to arouse emotions. It certainly does in my household, and so it does in this Room. I very much welcome, though, a national conversation about these issues. It is the right time to be having it.
As noble Lords have pointed out, we face two major challenges. The first is that too many people are overweight or living with obesity. I have already spoken this week about this grave challenge faced by this country, which was clearly outlined by the World Obesity Federation report on Covid death. That is a real wake-up call. The Government have already swung into action to a degree. More is planned. We are trying our hardest to address the knotty problem that few countries have ever completed successfully.
The second issue that the country faces is that too many people have eating disorders that make their lives a misery and threaten their health. I am grateful to noble Lords who have spoken movingly on this subject. Although she did not speak this afternoon, I reference the noble Baroness, Lady Bull, who recently arranged a stakeholder session with me that gave me first-hand testimony from those seeking to address these important issues.
I fear that poor old BMI, the much-maligned metric and subject of this debate, has in some ways become a surrogate and a scapegoat in a battle between two groups that see these two big issues—obesity and eating disorders—as somehow in conflict with each other. I do not want to take sides in any such battle. While I always welcome policy dialectic and the battle of ideas to hammer out the most sensible policy on complex issues, I do not think this should be a zero-sum game with winners and losers on opposing sides. Instead, I would like to work towards finding a way through, because it is imperative that, as policymakers, government Ministers understand the impact of our policies in one area on our policies in another area and somehow find a way of tackling them both in a complementary fashion.
Before I try to do that, let me say a few words in defence of the poor old maligned metric, BMI. It is, as noble Lords have pointed out, a very simple calculation—body weight divided by the square of height. It has been used by the National Institute for Health and Care Excellence, the World Health Organization and countless health organisations around the world for decades as just this: a simple first step to establish if individuals might be carrying too much or too little body fat for their long-term good health. To answer the noble Lord, Lord McNally: as risk assessments go, BMI has proven value year after year, study after study, in countries around the world, for predicting premature death and many chronic diseases, including type 2 diabetes, some cancers and some heart disease. As my noble friend Lady Jenkin rightly pointed out, it is simple to measure and highly reproduceable. It does not require specialist equipment or clinical training, unlike many methods of assessment noble Lords mentioned.
None the less I recognise, as the noble Lord, Lord Addington, pointed out, that it is not perfect for all people. Muscly athletes are considered too fat, and it is problematic for the very old. It is not unique, and, as the noble Lord, Lord Thomas, pointed out, a measuring tape around the waist is also very insightful. But it works for most people very well. The reality is that most people who have a high BMI are also at risk of ill health and premature death. When establishing an individual’s health risk, the noble Lord, Lord Brooke, is right: health professionals must use follow-up measures and assessments as well, such as waist circumference. NICE is crystal clear about this and, as my noble friend Lady Wheatcroft pointed out, BMI is just the recommended first step in the assessment pathway.
I hear the noble Baroness, Lady Parminter, loud and clear. I have read the stories to which she referred. I am extremely disappointed by them. It is not right and it is not recommended in the eating disorder commissioning guide. I agree that we need to listen to patients much better. I agree completely with my noble friend Lady Altmann that, in such cases, mental health assessments are absolutely essential. Similar safeguards apply to assessing whether someone is underweight, and of course it is absolutely true that conditions such as anorexia and other eating disorders require specialist assessment. NICE is looking at ways to improve the metric for ethnicity and other factors. None the less, given the large international evidence base underpinning BMI, its simplicity and its wide international use, I do not see it as likely that there will be wholesale change.
BMI is an essential tool in our battle against obesity. We have a huge problem in this area: six out of 10 adults and more than one in three children aged between 10 and 11 are overweight or living with obesity. In my briefing, I have page after page on the impact of obesity on the lives and futures of British families. It has a huge impact on the NHS, the causes of cancer and the causes of diabetes. It has an impact on women: obese women are 12.7 times more likely to develop type 2 diabetes and three and a half times more likely to have a heart attack than women who are a healthy weight. I could go on and on.
As the noble Baroness, Lady Redfern, rightly explained, it is children who are overweight or living with obesity who are sometimes affected the most. In particular, many experience bullying, low self-esteem and a lower quality of life. They are more likely to continue to be overweight or living with obesity into adulthood, which in turn increases their risk of type 2 diabetes, cardio- vascular disease and other chronic illnesses. We must do something to address this issue.
As the noble Lord, Lord Brooke, and my noble friend Lady Jenkin rightly said, during the pandemic we have seen a stark illustration of the impact of living with obesity. That is why we are acting. To answer my noble friend Lord Bourne, we are tackling the nation’s obesity with a new strategy. Published in July last year, it set out measures to get the nation fit and healthy, protect against Covid-19 and protect the NHS.
As my noble friend Lady Jenkin pointed out, there are many nudges in shops, on TV, on computers and on phones that encourage us to buy less healthy food. The Government are committed to restricting further the advertising of less healthy food on TV, and we are considering online restrictions on the promotion of less healthy food in shops. We are also committed to calorie labelling in restaurants and improving front-of-pack labelling on pre-packed foods. These actions are about helping people to make healthy choices.
At the same time, there is another issues that we must face: the national crisis around body identity and self-confidence, which, in some, manifests itself as extreme eating disorders or as mental health challenges. The Women and Equalities Committee report put it extremely well. Acute anorexia is a particularly distressing mental health condition that can ruin lives and cause horrible worries for the families of those concerned. That is why our mental health recovery plan is putting £500 million into work to ensure that we have the right support for people with mental illness, and I am encouraging further policy on positive body imagery.
I want to make my point clearly: I am concerned that there is a perception that these two agendas are somehow at odds with each other—that if we put calorie counts on menus, we will somehow trigger mental health episodes for those with eating disorders or reinforce a damaging body image culture, or that if we push our message on healthy lifestyles too much, we will stigmatise those with sensitivities about their body image. I simply do not accept that this needs to be the case. While I do not discount people’s lived experiences, it is important that we know what we are buying. The calorie count of everyday food available in fast-food chains is often absolutely shocking. The food we grab on the go or have delivered to our homes is now a big part of our diet, yet there is huge ignorance about what that food contains.
Collectively, we need to somehow work a way through this. The maths of it are really simple: there are 725,000 people with eating disorders in the UK. That number may be higher, as I recognise that some struggle to seek support and are not included in the figures. We must do everything we can to bring them the clinical support they need to address their significant mental health issues, so that they can live resilient lives and deal with the stresses of everyday living. At the same time, there are millions of schoolchildren and young people living with poor mental health. My DCMS colleagues are doing everything they can to address the challenges of social media in their lives.
In addition, there are 28.9 million adults in England who are either overweight or living with obesity. Somehow, we need to inspire those people to take on board a healthy lifestyle, which means changing their diets and taking more exercise. These are tough decisions that people can only make for themselves. It is not our business to deal in shame; we are dealing in honesty. That is where the BMI comes in, because it is a simple, unequivocal and, for most people, accurate predictor of risky lifestyles.
It is not beyond our intellectual capabilities to find a way through this conundrum. I am hugely grateful to the noble Lord, Lord Addington, for bringing us the opportunity to debate these sensitive subjects, and I hope very much that we can work together to find an answer to this challenge.
My Lords, I add my thanks to those offered to the noble Baroness, Lady Finlay, for initiating this debate. I refer the Committee to my interests as set out in the register.
I want to make just one quick point today: my belief that we need to be more careful about how we talk about the negatives of consuming alcohol and the need to be balanced in the advice given. Throughout this pandemic, we have seen the effects which lower socialisation has had on people’s health and mental health. I have always believed that a society which socialises together is stronger and healthier. Although alcohol does not have to be integral to a healthy social life, moderate alcohol consumption undoubtedly plays a large part in British culture and the social lives of many millions of people who enjoy pubs, clubs, bars, restaurants or indeed entertaining at home.
It is widely acknowledged that the comments made by the previous Chief Medical Officer, Dame Sally Davies, when she said that women should think about the risk of breast cancer every time they reach for a glass of wine, were misjudged. They were ultimately rebutted and reworded, but the horse had already bolted. Another, more recent example is from Drinkaware, which advised people getting their Covid-19 jabs not to drink in the two days before the jab and for up to two weeks afterwards. That advice then had to be dismissed by Ministers and the UK’s Medicines and Healthcare products Regulatory Agency, not least because not one study has tested any correlation between alcohol and the efficiency of either of the vaccines on offer in the UK today, a fact that even Drinkaware acknowledged.
Questions should be raised with Drinkaware about how this irresponsible advice could ever have been given, not least by the drinks industry, which for some reason continues to fund it. The problem caused by this type of nonsense advice is that it helps create a sense that all advice on alcohol consumption is nonsense. It undermines sound and sensible advice given by Governments and related health industries. Yes, of course overconsumption of alcohol is unhealthy, but our modern-day temperance movement needs to temper creating fear and to start acknowledging that most people have common sense and just enjoy a modest drink.
My Lords, there is always a danger when addressing lifestyle choices that policymakers indulge in overreach. The relentless war on alcohol emanating from public health over recent years is no exemption. This can mean the state trampling on individual agency, a point well made by the noble Lord, Lord Bethell, in yesterday’s Question on obesity. There is another danger when reports are commissioned to look at harms: that they see only harms and see harms everywhere. This can mean a disproportionate focus on risk and a loss of balance.
My concern about the direction of this report is that it moves away from the sometimes exaggerated health harms of individual alcohol use into the broader social and economic realms. In doing so, it may deploy guilt by association by linking alcohol and drinkers with reprehensible behaviours such as domestic abuse, family neglect, crime and child suicide and with a financial burden on public services. There is also the danger of conflating causation with correlation. This can mean that harms associated with a small minority are projected population-wide. Indeed, the proposed illiberal solutions, such as minimum pricing, treat everyone as a potential problem drinker and alcohol per se as a harmful substance.
Surely we need balance. Alcohol is a legal and enjoyable part of human engagement and relaxed sociability for millions of people. The direction of this report could disproportionately penalise and unfairly demonise the vast majority of those who drink responsibly.
Finally, can we remember the hospitality industry? With lockdown, some 10,000 pubs, clubs and restaurants were forced out of business in 2020. That awful loss of jobs and livelihoods looks set to continue. We have seen curfews and pubs open but with alcohol banned in Scotland and Wales. This smacks of a joyless puritanism. I appreciate that I am almost a lone voice here, but there is no democratic mandate for “Temperance UK”. Policy interventions should be targeted, discreet, and aware that alcohol can be harmful but usually is not, and that grown-ups should be free to choose how they use alcohol regardless of risks.
My Lords, the University of Cambridge has just said that we have little to lose from the widespread adoption of face masks, but the gains could be significant. On 15 June, face coverings will be mandatory on public transport in England. On 5 June, the WHO updated its guidance on using face masks.
Does the Minister agree that the reduction of social distancing from two metres to one metre is really crucial now? The risk goes up from 1.3% to just 2.6% by doing so. Denmark has moved to one metre, as have France, Singapore, Hong Kong—I could go on. From a business point of view, one metre could be the difference between survival or bankruptcy. A pub or a restaurant can operate at barely 30% with two-metre social distancing; with one-metre social distancing it can operate at more than 70%. With one-metre social distancing, we can get four times as many people into any space than with two metres. The difference between opening or not is for not just the hospitality sector, which employs 3.5 million people, but schools, theatres, cinemas and universities. The wearing of masks on public transport can add to making one metre even safer. For the sake of our economy and livelihoods, could the Government please bring social distancing down from two metres to one metre immediately?
Back in March, we were told by the Health Secretary, Matt Hancock, that the science behind the general population wearing masks was “extremely weak”. At the same time, the WHO said to wear masks, and Germany and the others followed. Two months later, based, presumably, on new evidence that no one has seen—if, in fact, there is any evidence at all—we have advice on transport and hospitals; I am not sure about advice for care homes, or whether they have been forgotten again. The WHO continues to advise 1-metre distancing, and that is immediately followed by France, Italy and the others. Meantime, we poor souls have to stick with 2 metres, and a whole host of queries around why the WHO advice is yet again being ignored. Frankly, this is not acceptable.
My Lords, it is a pleasure to contribute to this debate in the name of the noble Lord, Lord Hunt of Kings Heath, on amendments to the NHS commissioning rates for the provision of NHS-funded nursing care to eligible residents in nursing homes. I declare my interests as outlined in the register, in particular as a registered nurse myself.
Prior to October 2007, there were three rates for NHS-funded nursing care, which were replaced with a single band for all newly eligible residents. The small number of residents who had been in receipt of the former higher band, prior to September 2007, have been protected and will continue to receive the higher band, unless their needs reduce. Therefore, the statutory nursing care funding for the majority of those entitled has increased to £183.92. This came into force on 20 May and will be backdated to 1 April. This is welcome.
The increase reflects the recommendations of an independent study produced by LaingBuisson into the 2019-20 rate. However, the research was conducted between November 2018 and February 2019, before Covid. Therefore, the report does not appear to take into account the increased cost of PPE equipment and the nursing time associated with its use in nursing homes. However, PPE is essential to prevent the transfer of Covid-19 in nursing homes; as we know, their residents are particularly vulnerable to severe problems when infected with the virus, including in many cases, sadly, loss of life.
I understand that the proposed uplift will be dealt with by NHS England and NHS Improvement. Will the Minister clarify whether additional funds will be made available to CCGs to fund the increase in nursing care payments, or will it have to be funded from this year’s allocations to CCGs? Will the Minister also explain whether there are any plans to fund CCGs to make additional payments to nursing and care homes for the additional costs of PPE equipment and staff time associated with both the changing and using of PPE for nursing and personal care work undertaken by staff for residents—for example, to include the changing of urinary catheters and stoma bags?
I welcome the uplift in the rates for nursing care, but, in the absence of a long-term plan for funding care provision in residential homes, ask whether Her Majesty’s Government should make further extra financial provision, for at least the next year, to ensure the safe and effective use of PPE to protect residents in the light of the number of deaths in care and nursing homes attributable to Covid-19.
My Lords, I too support the long-overdue pay increase for nurses working in the social care sector. I also strongly support the regret Motion tabled by the noble Lord, Lord Hunt, who is right to draw attention to the financial instability of this deeply fragmented sector.
There are approximately 15,000 care homes in the UK, with more than 400,000 beds, run by approximately 8,000 providers. Some are very small; others provide a large network of homes. It is a mixed economy: 84% of homes are owned by the private sector, including some that are owned by private equity firms, both British and offshore; 13% are owned by not-for-profit organisations; and 3% are owned by local authorities. Funding comes from a mix of private funders, local authorities and the NHS. Despite this funding mix, care homes have been hit by a decade of cuts in social care funding. An FT investigation last summer revealed:
“Britain’s four largest privately owned care home operators have racked up debts of £40,000 a bed, meaning their annual interest charges alone absorb eight weeks of average fees paid by local authorities on behalf of residents.”
Many have argued that this debt-laden model is completely inappropriate for social care, as is one that involves paying large dividends to investors.
Many homes are already running close to bankruptcy and have expressed grave concerns about the spiralling costs of PPE and extra agency staff, as well as lost income from empty beds. It has been estimated that when bed occupancy rates slip below 87%—as many have now—operating surpluses are such that many smaller care homes quickly become unviable, particularly those with greater reliance on state-funded residents.
This virus has brutally exposed systemic weaknesses in our social care sector. The latest official figures show more than 12,000 Covid-related deaths of care home residents in England and Wales, but it has been estimated that the true figure, calculated by looking at excess deaths of care home residents in the period, could be double that. According to a recent poll, one-third of people say that they are less likely to seek residential social care for their relatives or as a future option for themselves. This brings into very sharp relief the respective responsibilities of central and local government if care home owners go under financially or simply decide to shut up shop and hand back the keys. Simply put, who is the provider of last resort?
Tellingly, that poll also revealed that the vast majority of respondents want care workers to be paid above the minimum wage. If this pandemic has revealed one thing, it is that we can no longer kick the can down the road but must take advantage of the growing public and political consensus that social care should be free at the point of need, funded largely out of taxation. There are, of course, a number of ways of doing this: general taxation, hypothecated tax, or some form of social insurance. This needs to be at the nub of both the political debate and a grown-up national conversation.
I thank the noble Baroness for her question, which I think I understood. If I understand correctly, she is asking about those who live in social care and residential care. I commend the work of Helen Whately, the Social Care Minister, who has been an amazing champion for social and residential care. She holds our feet to the flames daily to ensure that more work is being done. Testing is one area where we have made huge progress. The provision of PPE, raised by the noble Baroness, Lady Brinton, is another, despite everything noble Lords might have read. I pay tribute to my noble friend Lord Deighton, who has brought about a huge amount of manufacturing in the UK. There is, however, more that we can do and we are working as hard as we can.
The noble Baroness asks a good question. One thing that changed was that there was a large amount of representation from those being shielded that the mental health consequences of their isolation were having a profound effect. There were very touching and moving stories, and the scientific analysis of that was extremely persuasive. We have sought to be flexible, but the advice remains very clear: those who are clinically vulnerable have to take extremely good care of themselves. Even though the prevalence is lower, they have to be aware of the consequences of this awful disease.
I reassure the noble Baroness that the data is being centrally aggregated. ONS has published figures on ethnicity and the CMO and PHE are both scrutinising them. On their list of issues to consider is the role of vitamin D, where the evidence is interesting but unproven.
I reassure the noble Baroness that we have a large amount of data—although we could do with more and better. The collection of death certification data, for instance, has already improved dramatically and we are working hard to ensure that the evidence is there to inform our policy-making.
The noble Baroness, Lady Bull, asks a searching question. On whether the Mental Health Act easements of which she speaks have already been enacted, I will have to find out exactly what those arrangements are and write to her. However, I assure the House that the care of the most vulnerable is absolutely the Government’s number one, top priority. It is true that some of those caring and providing important pastoral care for the most vulnerable have been worst hit by Covid—the examples she gives are really good ones—but we are absolutely putting the care of the most vulnerable at the top of our priorities.
My Lords, the advice from the Government is that the clinically extremely vulnerable should continue to be shielded until the end of June. That is under review at the moment. We are seeking to have more refined and more targeted guidance after the end of June, and we will publish that before the end of that month.
The noble Lord, Lord Patel, asks an incredibly perceptive question. The ultimate decisions will be made by the CMO, who, as noble Lords know, has enormous experience in this exact area. Serology tests play an extremely important role in this by giving an indication of the number of antibodies there are, whether people have a degree of immunity and therefore a sense of how far the virus has spread through the community. However, we are aware of reports that there are recurrences of the virus in people who have emerged and recovered. That creates a great sense of concern around our serology tests.
The noble Baroness is entirely right that the use of PPE—certainly in the workplace and, more commonly, in other parts of our life—is likely to be part of our lives in the forthcoming period. However, to date, the British Government have been sceptical about the efficacy of face masks. We do not want to be in a position of misleading or providing false reassurance for the public when there is not sufficient scientific evidence for the relevance of face masks. However, should that evidence emerge and should the guidance change, we will of course follow the science and make the recommendation if it is helpful.