Covid-19: Restrictions

Debate between Lord Bethell and Baroness McIntosh of Hudnall

Thursday 7th January 2021 Lords Chamber

[Lord Bethell (Con)]

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

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

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

Coronavirus Act 2020 (Expiry of Mental Health Provisions) (England and Wales) Regulations 2020

Debate between Lord Bethell and Baroness McIntosh of Hudnall

Wednesday 25th November 2020 Grand Committee

[Lord Bethell (Con)]

My Lords, I thank noble Lords for a thoughtful and at times very generous debate, for which I am enormously grateful. I thank the noble Lord, Lord Davies of Brixton, for a remarkable maiden speech and offer him a sincere welcome. He laid out his stall very clearly, first as a man of numbers—as many have noted, the debates of the House of Lords benefit from those who are numerate and articulate with numbers as well as words—secondly, as a supporter of the trade union movement, and I look forward to his interventions as a trade unionist; and thirdly, as a man of compassion. He spoke movingly about mental health and the provisions in these regulations, and has marked himself out as someone who I hope will make an important contribution to our health debates—he will be extremely welcome indeed.

We are aware that many people are facing unprecedented strains due to the pandemic and the measures to contain it. The mental health of everyone is absolutely critical in these unprecedented times. We know that some people will experience exacerbated mental health problems as a result of the pandemic, as has been noted by the noble Baroness, Lady Barker. Moreover, people with existing mental health conditions and front-line workers are particularly susceptible.

The noble Baroness, Lady Tyler, noted that self-reporting has gone up. Public Health England’s Covid-19 mental health and well-being report concluded that the UK population’s self-reported mental health and well-being worsened during the pandemic. The largest decline was in April 2020.

Average levels of mental distress have been reported as going up, as the noble Baroness, Lady Fox, noted, although by 8.1% measured by GHQ 12, not the high levels that some noble Lords have referred to, indicating an increase in the severity of mental health problems overall. A robust follow-up survey from July 2020 of children and young people aged five to 16 who were interviewed for the national mental health prevalence survey in 2017 suggests that rates of probable mental health disorder have increased from one in nine in 2017 to one in six in July 2020—a very regrettable development.

We understand that there is increasing evidence of significant mental health consequences for people who have contracted Covid and evidence that Covid itself impacts the central nervous system, which can affect mental health and well-being. Survivors of Covid appear to be at increased risk of psychiatric disorder. For patients with no previous psychiatric history, a diagnosis of Covid was associated with increased incidence of a first psychiatric diagnosis in the following 14 to 90 days, compared with six other healthcare events.

I reassure all noble Lords who have spoken that mental health continues to be a priority for this Government. We are doing our utmost to ensure that our mental health services are there for everyone who needs them during the pandemic. I reassure the noble Lord, Lord Blunkett, that that is why in today’s spending review the Government have announced £500 million more for mental health support for new specialist services for children and young people, plus extra assistance for people with severe mental health illnesses and faster help for those afflicted by depression and anxiety.

The well-being and mental health support plan for Covid-19 published this week is a demonstration of the Government’s firm commitment to support the mental health of everyone throughout this winter and beyond. It outlines the support available to people over the coming winter. This is just one element of our work to deliver a modern mental health service and meet the demands created by the pandemic. We have announced two new commitments to support individuals: first, a winter discharge support package backed by £50 million, which will boost capacity and support good-quality discharge from mental health in-patient settings to help reduce pressures on in-patient beds and keep patients safe over the winter. Secondly, we are taking action to support the physical health of individuals with serious mental illnesses this winter, including support for systems to deliver local, system-level tailored engagement with patients and to develop national thought leadership on outreach.

We are absolutely committed to continuing our investment in expanding and transforming mental health services in England. This will amount to an additional £2.3 billion of extra funding a year on mental health services by 2023 to 2024. I reassure the noble Lord, Lord Hunt, that we are taking a range of steps to support mental health services to be able to manage pressure over the winter period.

Above all, it is essential that the message is heard loud and clear across the country that NHS mental health services remain open for business and will be available throughout the winter. The earlier people receive support on their mental health, the more likely they are to benefit. However, in April this year, only 57,000 referrals were made, compared to 133,000 in April 2019. While figures for more recent months show that referral rates are recovering, they are significantly below last year’s. To help address this, last week we launched a new phase of our NHS Help Us, Help You campaign to encourage anyone suffering from anxiety, depression or other issues.

We will continue to make sure that mental health services, including hospitals providing in-patient treatment get equal access to PPE. All health and social care staff can access priority testing when they show symptoms, including those providing mental health services in hospitals. NHS staff without symptoms can also be tested at the discretion of their NHS trust. Hospitals can test patients, including those admitted with mental health conditions, even if there is a higher prevalence of Covid-19 in their area.

GP surgeries have been requested by NHS England to make improvements to ensure that the physical health of those living with severe mental illness is protected this winter. This includes asking practices to identify people with severe mental illnesses who are clinically vulnerable and offering those people comprehensive physical health checks and follow-up interventions, free flu vaccines to those eligible and a care plan review as appropriate.

The NHS has worked hard to keep mental health services going during the first peak, using technology where needed, but also face-to-face appointments where appropriate. All mental health trusts have established 24/7 urgent mental health helplines, where people experiencing a mental health crisis can access support and advice. In addition, we have provided £10.2 million of extra funding to support mental health charities, including the Samaritans and the Campaign Against Living Miserably.

Talking therapies will continue to be made available remotely, so that people can access help safely from home. The NHS will work to ensure that the option of face-to-face support, quite rightly alluded to by the noble Baroness, Lady Barker, and the noble Lord, Lord Walney, is provided to people with serious mental health illnesses where it is clinically safe to do so.

Public Health England has published its surveillance tracker to monitor the impact of Covid-19 on the population’s mental health. This is a proactive step which will help to ensure that our response to the effects of Covid-19 on mental health and well-being is shaped by emerging data.

The Government have committed more than £400 million over the next four years to refurbish mental health facilities, getting rid of dormitories in mental health locations and benefiting the patients of 40 trusts across the country. We are committed to supporting our staff and investing in the workforce. NHS England and NHS Improvement are also investing £15 million to ensure that all staff get rapid access to expanded mental health services. Staff who are referred will be assessed rapidly, will be treated by local mental health specialists and, where appropriate, will be referred to specialist centres of excellence.

A number of noble Lords, including the noble Lord, Lord Davies, and the noble Baroness, Lady Tyler, asked about Sir Simon Wessely’s independent review of the Mental Health Act. I reassure noble Lords that work is well under way to respond to the review, and we will publish our White Paper in due course. This will pave the way for far-reaching reforms to the legislation and practice, strengthening the rights of patients and upholding the principles of dignity, autonomy and choice, which were enshrined in the review’s recommendations.

Since the Coronavirus Act was introduced, the Government have remained committed to keeping all elements of it under close review and to sunset any provisions that are no longer needed. As I set out earlier, the emergency modifications to the Mental Health Act made by the Coronavirus Act were designed to protect patients by supporting services to be able to continue if unprecedented constraints in the mental health sector put patients’ safety at risk during the pandemic. These provisions were only ever to be used as a backstop, as I told the Committee earlier.

The noble Lord, Lord Blunkett, referred to the very moving speech of the noble Baroness, Lady Grey-Thompson. I remember her words extremely well. Decisions, over which we have no control whatever, about our uselessness will be taken by someone else in the next few months. I am very pleased that the provisions have not been switched on. I reassure noble Lords that at all times the Government have remained conscious of the need to balance those provisions against the rights of individuals detained under the Mental Health Act.

Those provisions have not needed to be switched on due to the adaptations that have been made because of the resilience and commitment of NHS staff. As a result, we believe that now is the right time to remove them so that it is clear to patients, carers, staff and stakeholders that they will not be used. The approval of these regulations by this House to remove these emergency provisions is an important milestone on the journey towards much-needed reforms to the Mental Health Act. These reforms—

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

The Division Bell is ringing. I wonder whether the Minister is coming to the end of his remarks.

[Lord Bethell (Con)]

I am.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

If the Minister would like to finish, I will then adjourn the Committee and there will be plenty of time for noble Lords to vote.

[Lord Bethell (Con)]

These reforms, which will see that patients have greater autonomy and control over their care and treatment, will be set out in the Government’s forthcoming White Paper on this subject.

Covid-19 Update

Debate between Lord Bethell and Baroness McIntosh of Hudnall

Thursday 12th November 2020 Lords Chamber

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

My Lords, I am extremely grateful for the thoughtful questions of the noble Baronesses. I shall try to answer them as completely as I can but will write on any that I have omitted. As regards the questions about students, the programme of works with universities is extremely ambitious. I pay tribute to vice-chancellors and university administrations for working extremely closely with the Government, with the test and trace service and the DfE to mobilising the necessary arrangements in order to achieve the return home for Christmas.

This will include a large amount of mass testing on university campuses and in digs. There have already been successful pilots at Durham and De Montfort, using a variety of testing techniques and formats. Some tests have been done using telemedicine, some using traditional clipboard and picnic table techniques. There is further testing piloting to be done, but the indications are that this is proving an extremely successful model. It means that students can look forward to returning home for Christmas, confident that those who have the disease have been screened, and families can look forward to seeing students safely again.

On the testing of NHS workers, I agree with the noble Baroness that it is a priority. We are moving quickly on this. The purchase of tens of millions of lateral flow tests is a complete game-changer, and we remain committed to providing testing for the 1.3 million NHS workers. We aim to use lateral flow tests for some of these tests. NHS workers are themselves clinically trained, and it is appropriate for them to be able to use these tests. Therefore, we believe we can change the course of staff testing in the NHS environment using the new technology and a new approach to testing. I am extremely grateful to NHS colleagues for their participation in this important initiative.

Turning to DPHs, the noble Baroness is right that this is an important breakthrough. Again, the rollout of the lateral flow tests is important in that. She asked me about care homes, and she could have equally asked me about schools. I can deliver the same message on both: we have been sensitive to the appeals by DPHs for autonomy—for them to be able to make their own decisions, use their local intelligence and use their insight. That is why we have been reluctant to give any firm guidance on how they could or should use those tests. It is entirely up to DPHs to use the tests in the way they choose. But it is our expectation that some of those tests will be used in care homes, though there are other provisions for care home testing, and some will be used in schools, as well as for outbreak management and community testing.

The period for isolation is a subject under constant and rolling review by the CMO’s office and the policy team at DPH. I wish I could provide some kind of breakthrough—that the virus had in some way changed and was no longer infectious in people after a week or eight or nine days—but I am afraid I cannot provide that information. The frustrating thing about this virus is that it sits in the back of the throat or nose and remains infectious for an unfeasibly long time. That is why we are cautious about making dramatic changes in the isolation protocols.

What rapid testing provides is the opportunity to do frequent testing. The noble Baroness asked me about seven-day PCR tests; more likely and efficacious would be regular testing, every day or every other day, using the lateral flow tests, to do some form of test and release. We believe that avenue is more likely, and the CMO’s office is looking closely at that. It is entirely up to that office to make announcements on that score.

On adult social care, I reassure the noble Baroness that adult and child social care colleagues are fully involved in the preparations for a vaccine. She is right that social care provides its own set of challenges for the administration of the vaccine, but those are exactly the people we need to target with the vaccine. That is why they, particularly the elderly, are at the highest level of the JCVI’s prioritisation list. We are putting all our efforts into making sure that the vaccine delivery works for them.

The noble Baroness asked about ethnic minorities. May I put the question slightly differently? A number of difficult-to-reach groups have seen a high infection rate. It is a priority for us to make sure that the message on the vaccine breaks through any cultural, linguistic, demographic or other social barriers to get through to those groups who need it. They are not groups defined by race or the colour of their skin but by their proximity or otherwise to the normal course of government. We have learned through Covid that these groups are incredibly important from a public health point of view. From a values point of view, we owe it to them to do our best to reach them and we are putting the resources in place to do that. As for children, we have no current plans to vaccinate them. In terms of international partners, we are very focused on ensuring that all the intellectual property and manufacturing resources that we can possibly effect are put to work to get the vaccine into the arms of those around the world.

On cold storage, I reassure the noble Baroness that we have been on this for months. We have been aware of the demanding storage need of the Pfizer vaccine for a substantial amount of time and cold storage arrangements have been put in place. It is not necessary for that cold storage to be literally at the end of every street because the travel time for the vaccine is reasonably flexible. We have in place exactly what we need, not only for the Pfizer vaccine but for the Oxford vaccine and the others in the pipeline. JVT and Dr June Raine at the MHRA were crystal clear when they said that safety will not be compromised. I endorse their comments.

I will say a few words about our approach to managing messages to those who might feel anxious about the vaccine. This is not a moment for rebuttal or for attacking those who have questions about the vaccine, whatever those questions are and however far-fetched they might be. Our approach is to take all questions at face value, tackle them sincerely and approach them in an open-hearted way. By being defensive we play into the hands of those who have bad intentions, and by being aggressive we only amplify those causing trouble. Instead, we want to have an open dialogue with those who have concerns to emphasise the safety of the vaccine and, more generally, the normality of taking vaccines. It is with that kind of approach that we hope to deal with those who have concerns about taking vaccines.

The noble Baroness, Lady Jolly, asked a number of questions about the app. I cannot give her precise numbers on absolutely everything she asked but I can reassure her on a couple of things. There have been 20 million downloads, not 10 million. Take-up of the app has been enormous and, week on week, we see a huge number of check-ins on the venue-based element of the app, which is a huge part of its effectiveness. It helps us enormously with contact tracing. As for Bluetooth and the battery, I am disappointed to hear that the noble Baroness has had trouble with her phone. On the whole, that is not the feedback we have had from users and the recent update has emphasised the low-energy aspects of the Bluetooth protocol that the app uses. We think it will improve the performance of the app and lessen its drain on the battery.

The noble Baroness asked about tests; I will answer broadly. The innovation that we have seen in diagnostics for Covid has been incredible. It has included far-fetched—to me at least—technologies such as mass spectrometry. Some innovations have used the plastic lateral flows, which, although low-tech in their appearance, use extremely advanced technologies and chemicals to achieve accuracy, speed and cost performance. Some, such as LAMP, have taken old technologies and repurposed them for a new use. It has been extremely exciting to see. It is my aspiration that we will see an inflection point in diagnostics in the UK. This will aid an overall strategic step towards early intervention and put diagnostics at the heart of our medical science. It has already played an important part for a long time, but this will put it centre stage. I pay tribute to the work of Professor Mike Richards, whose review of the future vision for diagnostics in the NHS provides us with a target to aim for as we expand and invest in our diagnostics around Covid.

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

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

--- Later in debate ---

[Lord Bethell (Con)]

My noble friend will be aware of the prioritisation list published by the JVCI. I am afraid that the over-50s, of which I am a member, are not highest on the list, but they are at least halfway down. Prioritisation starts with the over-80s and works down from there. I completely endorse my noble friend’s comments on dispensing doctors. We will be relying on all parts of the healthcare ecology to deliver the vaccine. It will be a massive national project. Getting to hard-to-reach rural communities is incredibly important, particularly people in those communities who are older and perhaps do not travel. Dispensing doctors pay a pivotal role in that, and I pay tribute to their contribution to the vaccine.

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

My Lords, the time allotted for Back-Bench questions has now elapsed.

Medicines and Medical Devices Bill

Debate between Lord Bethell and Baroness McIntosh of Hudnall

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn from the debate, so I call the noble Baroness, Lady Jolly. Is Baroness Jolly with us? I am going to call her one more time; then we will have to move on, I am afraid. Baroness Jolly? Apparently not, so I now call the Minister.

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

My Lords, I give profound thanks for the debate on this group and start by reassuring the Committee that safety is very much at the heart of the Bill. Doing what is right for patients is at the heart of it but I acknowledge the remarks alluded to by my noble friends Lord Lansley and Lord O’Shaughnessy: patients are also entitled to have conversations with their doctors about what is right for them. That sometimes goes beyond a conversation about safety. To have those balanced, personal conversations to offer them hope, with innovative new treatments or in a clinical trial, we need other considerations to work together; we need the full picture and I want to make a few remarks on getting that balance right.

Before I do, I acknowledge the very touching and moving human stories that a number of noble Lords remarked on in this debate. I always find this subject extremely moving, and it is entirely right for us to remember the tough anecdotes and testimony of those groups which have advocated on behalf of the victims of terrible misadventure and clinical mistakes in the past. I also acknowledge what the noble Lord, Lord Alton, referred to as misogyny and what the noble Baroness, Lady Thornton, referred to as being ignored by the clinical profession. These two aspects of the situation weigh most heavily on my mind.

Before I move on to the testimony of the noble Baroness, Lady Cumberlege, I thank her for the hard work that she and her team put into her report. I reassure her and others that there is no question of the report in any way being buried or overlooked, or not cared about. The report, which was delivered in late July, is being weighed up with seriousness and intent. I reassure all those who are part of this debate that the Minister for Patient Safety, Nadine Dorries, is working up a response to it which will be delivered thoughtfully and with impact when the time is right. I completely and utterly recognise the support from across the House and from patient groups for the report’s recommendations and import.

However, patient safety is not the only aspect of the Bill, which we think needs to get the balance right between different aspects. Perhaps I may flag to noble Lords our amendment on this, Amendment 2, which inserts on page 1 at line 6:

“The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.”


We think that Amendment 2, agreed last Monday, gets the proportionate and balanced approach correct and that we have practical regulation which can rise to the challenge of public health. I spoke last week to the reason for Amendment 2; it is a floor, not a ceiling. It means that the appropriate authority must be satisfied that regulatory changes promote public health, which is an important introduction to the Bill.

Whenever we reach this House, we deal with matters of nuance. We have discussed my noble friend’s amendments to change the way in which considerations apply, to one of an “objective”. With Amendments 8, 55 and 73 the noble Baroness, Lady Thornton, has proposed additional curbs. She has asked for regulations to be made that

“act with a view to ensuring”

that three considerations are met. I would expect to be asked under what circumstances regulations might be made that do not

“act with a view to ensuring”;

It would not be scrutiny by noble Lords if I did not. When we looked at this construction, it seemed likely that matters we might well wish to regulate on that were not specific to the considerations would fall out of scope. The burden of proof that those regulations met the bar the noble Baroness would set would be very high. “Ensuring” is the question here.

Government Amendment 2, which was passed last week, sets that threshold for regulation, where the authority must be satisfied that regulation would promote public health. I hoped that it would satisfy, but I am open to further conversation with the noble Baroness on this and, of course, other matters.

If the root of the issue is how the considerations will be applied by the appropriate authority, the noble Baroness will be aware that the Government have tabled amendments to Clause 41. Those amendments would change the way in which consultation is run. We would be obliged to include initial thinking on how the considerations have been applied to the development of regulatory change proposals so far.

The noble Lord, Lord Sharkey, has with Amendment 9 also suggested that an assessment of impact on these three considerations be published alongside draft regulations. He knows that an Explanatory Memorandum and an impact assessment must be produced when making a statutory instrument. While we are not there yet, I draw his attention to government Amendment 131, which would oblige the Secretary of State to report to Parliament every two years. That report must contain concerns raised during consultation, with that consultation informed by the Government’s initial assessment of the considerations. Parliament will therefore have the Government’s assessment but also the public’s assessment of the Government’s assessment. I hope that that is reassuring to the noble Lord.

I started this group by touching on the importance of patients and I am grateful to my noble friend Lady Cumberlege for her Amendment 10. She has support for it. I fully understand and support the rationale for wanting medicines and medical devices to be safe for patients. However, Amendment 10, placing the safety of medicines above all other considerations, could inadvertently put patients at risk.

The noble Lord, Lord O’Shaughnessy, alluded to availability, for example. During the pandemic, much has been done to ensure supplies of medicines—new experimental medicines, old medicines for different purposes or medicines that are at least available when others are in short supply. We have introduced a number of regulatory flexibilities, which have been widely welcomed by industry. They have helped to secure continued supply in a very challenging situation.

While patient safety underpins everything that the MHRA does, these changes were introduced for the primary purpose of ensuring continued supply. If we placed the safety of a medicine above all other considerations, we might put the safety and health of the patient and wider public at risk should they not receive the medicines that they need.

It would also potentially mean challenges in getting patients new medicines. A medicine that is novel or offers a great deal of hope might be inadvertently ruled out because of concerns regarding poor clinical practice or potential use in patients for whom it is not appropriate. We do not want to deny a potentially effective medicine to all patients in all circumstances. By placing safety as the primary consideration, clinical trials would also be almost impossible to conduct. By their very nature, they seek to test the safety of medicines.

I understand the noble Baroness’s concerns. She is deeply motivated by a desire to prevent what has happened before from happening again. I have spoken to patient groups. I am a father of daughters and a husband to a wife. I was deeply affected by the speeches made at Second Reading. However, I think that her objective—the safety of patients, not the safety specifically of medicines and medical devices—is protected by the government amendments that were passed last week. We will not be able to make regulations if we cannot be satisfied that they promote public health. That rules out deregulation for deregulation’s sake, for instance, but it allows, particularly in the case of an emergency, getting treatment to patients.

I hope that the noble Baroness will understand that we are aligned in intent, if not in delivery. We have designed that overarching test—that the appropriate authority is satisfied—to deliver on the safety of patients without preventing, for example, regulation in a pandemic. I know that she has spoken to my officials. I welcome ongoing conversations through the passage of the Bill, in Committee and beyond.

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[Lord Bethell (Con)]

I will be candid with the noble Lord. The Cumberlege report has put patient safety absolutely at the top of the agenda. If it was not for Covid, it would be the primary issue of today in health matters and would lead all our thinking for the year ahead. The report is incredibly important and it has made its mark in a big way. However, it was delivered at the end of July and, if you take out August, that is only six or seven weeks ago. It takes a bit of time to respond to these reports. I know that the noble Baroness is chafing at the bit and wants a response—of course she does—but it has not been very long in report terms.

I cannot avoid the obvious, which is that we are in the middle of an epidemic. The Department of Health is completely overrun. We have nearly doubled in size in the past four weeks, but even so the capacity for response, in ministerial time and official time, simply is not there. I completely understand the keenness of noble Lords in this Room to get a clear response, but the sequencing is that this is a Bill on medicines and medical devices. We seek to take on board the lessons of the Cumberlege report and, where possible, specific items, but the Bill is not designed to be a vehicle for the implementation of the report recommendations. We will acknowledge and, where possible, accommodate the report’s insight, but the report needs a formal response from the Minister for Patient Safety and I am not that Minister and there has not been time for that response to arrive yet.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

My Lords, I will have one more go to get the noble Baroness, Lady Jolly, to join us. Lady Jolly? It is rather sad calling into the void. I take it that she is not able to join us, so I call the noble Baroness, Lady Thornton.

Medicines and Medical Devices Bill

Debate between Lord Bethell and Baroness McIntosh of Hudnall

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Monday 19th October 2020 Grand Committee

[Lord Bethell (Con)]

My Lords, I am enormously grateful to my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, for Amendments 5 and 70. I greatly appreciate their scrutiny and contribution on the way in which regulations under the Bill might be made. I am grateful to my noble friend for his constructive dialogue with my officials. His experience and expertise in making legislation on health matters is a real benefit to all of us.

My noble friend and the noble and learned Lord, Lord Woolf, have drawn on the framework of legislation in the EU context. I am grateful for their explanatory statement on the basis of the amendment. My noble friend knows that I pressed very hard to see whether this is something we could accept. The challenge your Lordships have set me is why, if this framework exists in EU legislation, is it too constricting for the Bill? The answer is that examples of significant recent EU legislation in relation to human medicines, clinical trials and medical devices include: directive 2001/83/EC, regulation 726/2004, regulation 536/2014, and regulation 2017/745. In other words, while citing the aim of safeguarding public health in Article 168, on public health, of the Treaty on the Functioning of the European Union, these pieces of legislation were also made in reliance upon Article 114 of the treaty, being measures for the approximation of laws which have as their objective the establishment and functioning of the internal market. To make that point again, safeguarding public health is not the only objective of the EU legislation in relation to medicinal products and medical devices. That is why we have a challenge in this area and why we have posited our amendment.

I shall say something about the other government amendments, specifically replying to the noble Lords, Lord Hunt and Lord Sharkey, and other noble Lords who commented on them. The overall timing of the Bill means that currently, it cannot reach Report any earlier than mid-November. If we start the consent process with Northern Ireland then, it will add a minimum of two months past the end of the Bill’s timeline. To explain to the noble Lord, Lord Sharkey, we need to start the consent process now in order to make further changes. The Government need to demonstrate that this is a policy they wish to make in order for Northern Ireland to get that process properly under way. We have written to Northern Ireland seeking consent to make changes. Parts 1 and 2 of the Bill are transferred to Northern Ireland. I sought consent from Northern Ireland on the Bill as a whole when the Bill was introduced, and again after the change made on Report to Clause 16.

We sought to make government amendments at the earliest opportunity to respond to the DPRRC, partly to demonstrate how significantly we take that report and partly to start this process. That process has now started, but it has not concluded. It does not preclude noble Lords from further consideration and, as my noble friend Lord Lansley, indicated, the Bill has moved. The process of consent is unavoidably three months long in order for the Northern Ireland Assembly to conduct its work. That is why we have had to start now. In reply to the noble Lord, Lord Hunt, I can supplement the legislative consent Motion at a later date.

I will listen. I understand and acknowledge that the noble Baroness sees this as the beginning, not the end, and I acknowledge that she will return to the issue on Report. Accepting these amendments today does not prevent her doing so, and I will continue to listen.

I completely hear what the noble Lord, Lord Hunt, says about engagement with the MHRA. I would be glad to arrange a suitable engagement with June Raine from the MHRA and parliamentarians to discuss these points.

To the noble Lord, Lord Patel, I confirm that the efficacy of a medical device is assessed as part of the process of obtaining a CE certificate. The therapeutic value of a device is not part of the CE certificate assessment; that is a function carried out by NICE. On the point made by the noble Baroness, Lady Barker, on the food chain, I would be glad to arrange a follow-up discussion on the veterinary medicines directorate with the relevant Defra Minister. To the noble Baroness, Lady Jolly, Defra and BEIS are content with this amendment. To the noble Baroness, Lady Walmsley, the medical devices section of the overarching bit at the beginning of the Bill is a carry-on from the sentencing enforcement, and in Part 3 enforcement is in relation to medical devices only. I do not think these are reasons to rewrite the purpose.

I obviously hope to win the argument on some of this, but that will come from extensive engagement and thorough communication going forward, for which I thank noble Lords. I therefore hope that the noble Baroness feels able to accept these reassurances, and I am grateful that my noble friend considers this sufficient reassurance not to move his amendments.

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

I have received a request to speak after the Minister from the noble Lord, Lord O’Shaughnessy.

[Lord O’Shaughnessy (Con)]

I thank my noble friend for addressing the point about therapeutic use, but I think I am slightly more confused now than I was before. He talked about NICE, but of course, NICE does not assess every medical device and assesses from a health economics perspective, as opposed to a purely regulatory, safety and efficacy perspective. It is not something that need detain us, but perhaps he could follow up afterwards with a bit more detail.

Mental Health Services

Debate between Lord Bethell and Baroness McIntosh of Hudnall

Tuesday 19th May 2020 Lords Chamber

[Lord Bethell]

The noble Baroness rightly points to one of the most difficult aspects of the Covid epidemic—the itinerant staff who pass from one vulnerable person to the next. We recognised this issue at the beginning and put money in to try to ameliorate it. When testing was expanded weeks ago to key workers, it was deliberately targeted at these staff and this continues to be prioritised.

[Baroness McIntosh of Hudnall (Lab)]

My Lords, children’s lives have been disrupted, not only educationally but socially and emotionally, as friendship patterns have changed. The Minister will know that these relationships can be fragile but are essential to good mental health and well-being. What are the Government planning to do to provide additional support to schools to help with the problems they will inevitably encounter when children return?

[Lord Bethell]

The noble Baroness is entirely right. I am living with four children who are greatly distressed at losing their friends and not being able to stay in touch in the way they would like. We will undoubtedly need to provide support to schools to cover a list of mental health issues. The Secretary of State for Education is working on plans for that.

Covid-19 Update

Debate between Lord Bethell and Baroness McIntosh of Hudnall

Monday 16th March 2020 Lords Chamber

[Lord Bethell]

My noble friend Lord Barwell is entirely right. The question of deliveries is an acute concern. There are intense conversations going on on a daily basis between Defra and the food retailers. I understand that there are assurances that there are significant stocks of food and that these are going to be made more available. It is not something that we are currently deeply concerned about. The belief is that as people fill their larders, they will reach a certain point when they will begin backing off the kind of stocking up that they are doing at the moment and it will be possible for those who need it to get those deliveries.

[Baroness McIntosh of Hudnall (Lab)]

I am sorry to ask the Minister to return to the issue of closing theatres—and I declare an interest as the deputy chairman of the Royal Shakespeare Company—but reassurance is needed that, by following the instructions or the advice or whatever it is that has been issued, theatres and no doubt other businesses as well are not inadvertently invalidating their insurance arrangements. I understand that the noble Lord finds it difficult to give assurances but I think that one is particularly necessary, not least because it might save the Government some money in the long run.

[Lord Bethell]

The noble Baroness is entirely right. As a trustee of Sadler’s Wells, I understand completely the implications of what she is saying, her point about insurance, and the confusion there might be about what the current status is. I simply cannot answer the question right now. I am not trying to avoid a difficult question; I simply do not have the information. When I do, I will be very happy to write to her and to others who have asked about this.

Wuhan Coronavirus

Debate between Lord Bethell and Baroness McIntosh of Hudnall

Wednesday 26th February 2020 Lords Chamber

[Lord Bethell]

The noble Lord is right to emphasise this point. The clinical treatment of the virus is in part through the medicine itself. We have to be realistic about whether a medical solution to the virus will be found before the peak epidemic. One is instinctively optimistic that such a thing can happen, but it cannot be guaranteed. However, there are also the procedures and arrangements for nursing and looking after patients as they go through the cycle of the virus, and such best practice is absolutely the priority of the Chief Medical Officer. Arrangements have been put in place to spread that best practice through the trusts and CCGs that provide front-line care.

[Baroness McIntosh of Hudnall (Lab)]

My Lords, I was listening closely to the noble Lord, Lord Patel, when he was asking his question earlier. If I heard him rightly, he said that if this becomes a pandemic, four out of five people in this country might become infected. That is a very alarming number, not just because four out of five people will get ill but because of the impact on all kinds of social and other activities, including economic ones. Do the Government themselves recognise that figure as a likely outcome in a pandemic situation? Is any information currently available about the immunity, either short-term or long-term, that may or may not be conferred on those who have already succumbed to the virus?

Arrangement of Business

Debate between Lord Bethell and Baroness McIntosh of Hudnall

Monday 7th October 2019 Lords Chamber

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

Repeat of an Urgent Question asked in the House of Commons on proposed changes to the withdrawal agreement and the political declaration—

[Lord Bethell (Con)]

We would like to move on to the capital requirements SI, please.

[The Deputy Speaker]

My Lords, there may have been a change in the order of business as expressed in my brief, for which I apologise. I therefore assume that we will now hear the repeat of an Urgent Question—the tariffs? I hope that the House will bear with me while I discover what I am supposed to be asking the House to consider. Right—let us have another go.