Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022

Baroness Healy of Primrose Hill Excerpts

Monday 14th March 2022 Grand Committee

[Viscount Stansgate (Lab)]

Am I allowed to ask a question before the Minister replies? I notice that one of the SIs has an impact assessment attached to it and the other, related to early access to medicines, does not. When I looked at the explanation, it said that it does not reach the threshold required to undertake a full impact assessment. What is the threshold above which you are required to provide a full impact assessment?

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

My Lords, the noble Baroness, Lady Brinton, is taking part remotely. I invite her to speak.

[Baroness Brinton (LD) [V]]

My Lords, I will speak about some the issues raised by the noble Lord, Lord Lansley, in relation to the current levels of Covid, when we discuss later on the third of the SIs before us today. I welcome the two sets of regulations that we are discussing in this first section. The first, the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2022, modifies and extends regulations with a large number of measures relating to vaccinations for both Covid and influenza. The previous regulations were due to expire on 1 April. I want to put on record our thanks to Ministers and officials for the fact that, this time, we are considering a Covid SI before it comes into force. I hope that this will become routine again from now on.

This SI makes permanent changes to what medicines a range of registered healthcare professionals can administer to NHS and local authority staff. It could be transformational for the NHS if carefully assessed and if the wider group of staff have training and support built into their professional training. It is important that this is extended. The ability to deliver vaccines for coronavirus, influenza and—heaven help us—any other pandemic without the need for a wholesale dealer’s licence to be in place, and for the final stages of coronavirus vaccine preparation to be completed without those extra licences, is important. It is part of a complex legislative framework. I am glad that we do not need to discuss that today but, arising out of it, perhaps I may ask the Minister some questions.

There has been discussion in public in the past few days about the expansion of the fourth booster for certain groups. Can the Minister explain when, if a person has already had their fourth booster, as the severely clinically extremely vulnerable have already had, they would next expect a booster, which would in fact be their fifth? What is the timescale for those who are expecting a fourth booster, having had their third one in the autumn or more recently?

What are the Government doing to keep reaching out to hard-to-reach groups who are not yet fully vaccinated? On the case numbers going up at the moment, I think we all know that those in hospital with coronavirus are predominantly those who have not had any vaccines or their full vaccinations.

What progress is being made towards the development of nasal spray vaccines for Covid, such as the Fluenz Tetra nasal vaccines for influenza for children? Obviously, delivering nasal vaccines needs considerably less training for staff than do injections, although I note that the current flu nasal spray vaccine is live and therefore not suitable for the immunocompromised or immunosuppressed.

What are the Government doing to encourage pregnant and breastfeeding women to get vaccinated, given the confusion that there was last year and the delay before the JVCI said that they should be vaccinated?

As we lift restrictions, it is very much the unvaccinated who are at risk of serious illness, so what socioeconomic and ethnic divisions are there between the vaccinated and the unvaccinated? What has been the most recent clinical assessment of vaccine uptake for the severely clinically extremely vulnerable or, if the Minister prefers to call them this week, the immunocompromised and the immunosuppressed? That is a slightly naughty question because I know the answer, as does the noble Lord, Lord Lansley. We know that some will never make any antibodies at all, while others will make some but they will wane extremely fast.

I was interested to hear the noble Lord, Lord Lansley, discussing post-exposure prophylaxis trials, which are important. I note that, back in June and July last year, the Minister’s predecessor was telling us that pre-exposure prophylaxis treatment would be available very shortly, but in the last two or three meetings that I have been at with scientists and experts, they have said that it is much further away. I hope that the noble Lord, Lord Lansley, is right and that it is not far off. Can the Minister say whether it is going to happen? There is still a problem for the immunocompromised and the immunosuppressed in making sure that they get access to these antivirals and monoclonal antibody treatments.

I turn now to the human medicines amendments relating to the early access to medicines scheme. The review into EAMS in 2016 highlighted that, often, a medicine will be available to a patient under EAMS but, when it makes the transition to being fully available and is going through the final stages of approval, there can be a lull when patients are not able to access it. This is a very particular problem for those who were on it in the trial and for whom it is making their lives a lot more bearable and their health condition much more under control. Suddenly there is a period when they cannot access that medication. Is it proposed that this arrangement changes so that, if you are on a trial, you can continue on it until it definitely will not be approved, rather than having to wait? How will this legislation make that transition smoother? How are the Government prioritising pharmaceutical innovation for the clinically extremely vulnerable?

Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2022

Baroness Healy of Primrose Hill Excerpts

Tuesday 8th February 2022 Grand Committee

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

My Lords, this statutory instrument will amend the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. The 2014 regulations are currently due to expire after 31 March this year, and this statutory instrument will amend the expiry date to 31 March 2025. This is the only change this statutory instrument makes; it does not change any existing policy. The 2014 regulations set out the activities that are regulated by the Care Quality Commission and the fundamental standards that all CQC-registered providers need to comply with. These activities and standards will not be amended by this instrument.

The extension of the 2014 regulations to 31 March 2025 will ensure that the current regulations relating to CQC-registered providers, including which activities are regulated by the CQC, will continue to apply. There will be no change to how the CQC carries out its regulatory functions. The Government see the CQC’s role as critical in ensuring that the care received by patients is of high quality and delivered to standards that promote patient safety.

I should highlight that if we do not extend the expiry date, the 2014 regulations will automatically expire and there will be no regulated activities for the CQC to regulate, so providers who are currently required to register with the CQC will no longer be required to do so. Providers that are currently required to register with the CQC will also no longer be required to comply with the fundamental standards set out in the 2014 regulations, which help to ensure that services are carried out safely and to a high quality. The impact of not extending the regulations would be a risk to patient safety, as it would compromise the CQC’s ability to monitor providers against those fundamental standards.

In short, this SI will amend the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 by extending the expiry date by a further three years to 31 March 2025. This means that health and care providers in England that carry out any of the regulated activities set out in the 2014 regulations will continue to be required to register with the CQC and will be bound by the obligations and standards set out in the 2014 regulations. This will help to ensure that patients continue to receive safe and good-quality care.

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

My Lords, the noble Baroness, Lady Brinton, is taking part remotely. I invite her to speak.

[Baroness Brinton (LD) [V]]

My Lords, first, I thank the technical wizards who have mended the problem with the link to the Grand Committee so that I can contribute remotely. This sort of thing happens only very occasionally, and the smoothness with which most of the business goes on is extremely helpful. I am very grateful to them.

The Explanatory Memorandum says that these regulations are to ensure protection from Covid, and the Minister has explained why there is a requirement to extend the deadline for the department to carry out a review of the CQC regulations. However, why are a further three years needed? Perhaps he can explain how there will be accountability between now and then to enable the House and Parliament to see the progress. Given that we are talking about three years, will he undertake to provide your Lordships’ House with an interim report on progress? If it takes the full three years, can that be on an annual basis?

Finally, and perhaps most importantly, can the Minister outline how the review fits in with ongoing reforms such as the Health and Care Bill, which will come to the end of Committee tomorrow, and other social care reforms? Will it keep pace with all those new developments?

I want to add one other item. The Minister knows that, when we had the Statement in the Chamber last Thursday, I asked him why care homes had not yet received the details of the change of rules about the compulsory vaccination of staff. He kindly said at the Dispatch Box that he did not have the answers to hand but would write to me and my noble friend Lord Scriven, who also asked questions about this that day. I do not appear to have had anything. Given that this covers care homes and keeping patients safe, I wonder whether I can ask again.

On Wednesday afternoon, the director-general for adult social care wrote to providers of CQC-regulated adult social care activities about the removal of vaccination as a condition of deployment. Unfortunately, the problem is that it specifically excludes care homes. I believe we know that the problem exists in regulations that need to be revoked, but can the Minister explain to the Grand Committee exactly what the problem is? Clearly, reading that letter from the director-general at face value, care homes are sitting in a limbo which no other parts of the NHS or the wider settings for care are in, in that they should be applying compulsory vaccination.

The Minister said on Wednesday that the intention was quite clear. Unfortunately, this affects care homes, because it is to do with employment law. I know that some care homes have already been approached by staff they had to sack, asking whether they can have their jobs back, while they are still waiting to hear formally from government about when the revoking of the regulations will come into force. I hope the Minister can answer my question on this.

Medical Devices (Northern Ireland Protocol) Regulations 2021

Baroness Healy of Primrose Hill Excerpts

Monday 12th July 2021 Grand Committee

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

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.

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

The noble Lord, Lord Hunt of Kings Heath, has withdrawn, so I call the next speaker, the noble Lord, Lord McColl of Dulwich.

--- Later in debate ---

Motion agreed.

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

The Grand Committee stands adjourned until 3.35 pm. I remind Members to sanitise their desks and chairs before leaving the Room.

Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021

Baroness Healy of Primrose Hill Excerpts

Monday 12th July 2021 Grand Committee

[Lord Moynihan (Con)]

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?

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

The noble Lord, Lord Hunt of Kings Heath, has withdrawn, so I call the noble Lord, Lord Lansley.

[Lord Lansley (Con)]

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.

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

The noble Baroness, Lady Brinton, has withdrawn, so I call the noble Lord, Lord Scriven, in her place.

Body Mass Index

Baroness Healy of Primrose Hill Excerpts

Thursday 22nd April 2021 Grand Committee

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

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.

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

The Grand Committee stands adjourned until 3.30 pm. I remind Members to sanitise their desks and chairs before leaving the Room.

Alcohol Harm Commission: Report 2020

Baroness Healy of Primrose Hill Excerpts

Thursday 22nd April 2021 Grand Committee

[Lord Smith of Hindhead (Con)]

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.

[The Deputy Chairman of Committees (Baroness Healy of Primrose Hill) (Lab)]

As the noble Baroness, Lady Boycott, has withdrawn, I call the next speaker, the noble Baroness, Lady Fox of Buckley.

Covid-19: Masks

Baroness Healy of Primrose Hill Excerpts

Thursday 11th June 2020 Lords Chamber

[Baroness Healy of Primrose Hill (Lab) [V]]

My Lords, I too welcome the Government’s sadly rather late decision to advise the mandatory wearing of face coverings on public transport from next Monday. The Mayor of London had recommended this two months ago at the height of the pandemic, when drivers were already dying.

I asked on two occasions in late April when Ministers would consider encouraging the public to wear coverings, only to be told that there was insufficient scientific evidence to do so. Surely the Government must regret taking so long to make this recommendation. No one is suggesting that masks are a cure but, as SAGE said on 20 April:

“Wearing facemasks outside the house could complement existing government messaging of social responsibility”.


They could have helped to provide protection from others who showed no symptoms but were infectious. It is regrettable that the Government have again been too slow to act, disregarding lessons from abroad.

National Health Service Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) (Amendment) Regulations 2020

Baroness Healy of Primrose Hill Excerpts

Monday 8th June 2020 Lords Chamber

[Baroness Healy of Primrose Hill (Lab) [V]]

I thank my noble friend Lord Hunt for securing this timely debate. I absolutely agree that the long-term sustainability of care homes must be a priority for the Government both now and in the future. When will the long-promised Green Paper be published?

The pandemic has shone a fierce light on the lives of those dependent on social care. The public now understand the heroic work done by care staff, who must be rewarded with decent pay, security of employment and proper protection, with adequate PPE and access to regular testing. Can the Minister confirm that every care home has now received adequate testing kits, as promised by the Government, and can he assure me that these will be provided on a regular basis for all, with a guaranteed 24-hour turnaround time for results? Martin Green, chief executive of Care England, is clear:

“As the lockdown starts to ease … You’re going to have to have testing on a very regular basis. You might be having to test once a week in care homes.”


The Economic Affairs Committee’s radical report, Social Care Funding: Time to End a National Scandal, is still awaiting a government response. It calls for an additional £8 billion for adult social care immediately just to return it to the 2009-10 standards. Published before the pandemic, the report proved prescient by calling for proper investment in the care workforce, with a career structure which better reflects the skills required to be a good care worker and the social importance of the sector. Investment is essential now before a second surge. The Government must learn lessons from earlier mistakes and ensure that the social care sector can better protect its residents. Age UK says that residents are being charged to pay for PPE, as other noble Lords mentioned. Can the Minister confirm this?

The Health Secretary’s claim that he threw a “protective ring” around care homes already lacks credibility when research by LSE estimates that 22,000 “extra” deaths have occurred in care homes during this pandemic period. Many senior care industry figures have pointed to the decision to move some hospital patients back into care homes in mid-March, when testing was not available to them. Figures released by NHS England show that 25,000 patients were moved from hospitals to care homes between 17 March and mid-April, when the guidance formally changed to ensure that testing took place. Can the Minister confirm that, in future, no patient will be returned from hospital to a care home without being tested first?

Covid-19 has taught us important lessons about what matters and who we should value: not only our own families but those who care for them so bravely.

Covid-19: Response

Baroness Healy of Primrose Hill Excerpts

Wednesday 3rd June 2020 Lords Chamber

[Lord Bethell]

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.

[Baroness Healy of Primrose Hill (Lab)]

Could the Minister explain what changed between 12 May, when I asked him what advice could be given to those shielding and was told that they must remain inside until at least the end of June, and last Saturday evening, 30 May, when the advice suddenly changed with no warning and the clinically extremely vulnerable were told that they could go out?

[Lord Bethell]

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.

Covid-19: BAME NHS Staff

Baroness Healy of Primrose Hill Excerpts

Tuesday 19th May 2020 Lords Chamber

[Lord Bethell]

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.

[Baroness Healy of Primrose Hill (Lab)]

To follow further on the data, many medical bodies, and the Science and Technology Committee today, are calling for greater collection of real-time data on infection and deaths by protected characteristics, and for it to be recorded, analysed and shared so that urgent action can be taken to prevent deaths of front-line staff. What assurances can the Minister give that this work is actively underway now?

[Lord Bethell]

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.