Health Protection (Coronavirus, Restrictions) (Steps and Other Provisions) (England) (Amendment) Regulations 2021
Baroness McIntosh of Hudnall Excerpts(2 years, 10 months ago)
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Lord Bhatia (Non-Afl) [V]
My Lords, this SI has been prepared by the Department of Health and Social Care. The instrument revokes and replaces the health protection regulations 2020 and contains the legislative framework that will implement steps 1 to 3 of the Government’s road map out of lockdown in England. This instrument enables a number of public measures to be taken to reduce the public health risks posed by the spread in England of severe acute respiratory syndrome coronavirus 2, which causes the disease Covid-19. The SI also amends a number of other coronavirus regulations.
This SI is made under the emergency procedure set out in Section 45R of the Public Health (Control of Disease) Act 1984. Furthermore, this instrument is made without a draft having been laid and approved by a resolution of each House of Parliament. It is the opinion of the Secretary of State that, by reason of urgency, it is necessary to make this instrument without a draft being laid and approved, so that public health measures can be taken in response to the serious and imminent threat to public health posed by the incidence and spread of severe acute respiratory syndrome coronavirus 2.
This instrument was laid and published and came into force on 29 March 2021, and the measures will expire at the end of 30 June 2021. This instrument will cease to have effect at the end of the period of 28 days, beginning on the day it was made, unless during that period it is approved by a resolution of each House of Parliament. The Secretary of State must review the need for the restrictions imposed by this instrument at least every 35 days, with the first review taking place by 12 April 2021.
I support this SI as put forward by the Minister.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, the noble Baroness, Lady Gardner of Parkes, has withdrawn, so I call the noble Baroness, Lady Brinton.
Covid-19: Restrictions
Baroness McIntosh of Hudnall Excerpts(3 years, 3 months ago)
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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.
Health Protection (Coronavirus, Restrictions) (Self-Isolation and Linked Households) (England) Regulations 2020
Baroness McIntosh of Hudnall Excerpts(3 years, 3 months ago)
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Lord Mann (Non-Afl)
There is huge support out there for the lockdown, although everyone I know is asking, as am I, why our borders are open, because one thing is certain: if Donald Trump is allowed in during the lockdown, there will be a significant problem for the Government with public opinion.
Looking at the pace at which they are vaccinating, what is Israel doing right that we are not? Can I suggest some reasons to the Minister? My own GP service today is vaccinating for flu but is not allowed to vaccinate for Covid because of new Public Health England rules. I suggest that this is the same reason why pharmacies are not being allowed to vaccinate. It is not because they cannot, since they are vaccinating for flu at the moment, but because of Public Health England rules relating to Covid. I know a nurse, retired after 30 years, who has been re-recruited this week as an assistant and is allowed to vaccinate for flu, but despite that 30 years is not allowed to vaccinate for Covid because of Public Health England rules. Who will get on top of Public Health England? It strikes me that people keep attacking the Government, but the problem I have is with some of the actions of Public Health England, and this demonstrates that. This overcautious approach is delaying and will delay further.
I end not by talking about what is rightly going on with the prioritising of the most elderly and vulnerable, because that is appropriate. In the next stage, I predict that Public Health England will not allow workplaces to vaccinate but will allow the employer to take on the costs, the hassle and the administration. In an area such as the district I live in, 10,000 could be done in a day if they were done in the large workplaces. Then we would really be getting on top of the problem. Which Minister will take on and sort out the bureaucracy from Public Health England?
The Deputy Speaker (Baroness McIntosh of Hudnall) (Lab)
I call Lord Bhatia. He is not there. I call Lord Bourne of Aberystwyth.
Coronavirus Act 2020 (Expiry of Mental Health Provisions) (England and Wales) Regulations 2020
Baroness McIntosh of Hudnall Excerpts(3 years, 5 months ago)
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Lord Hunt of Kings Heath (Lab) [V]
My Lords, it is a great pleasure to follow my noble friend and I congratulate him on a fine maiden speech. As he said, he brings to your Lordships’ House a wide range of experience in the trade union movement, service on the GLC and as chair of ILEA, where he was a forceful champion of comprehensive education. However, I rather think that his being the first actuary to enter the Lords for more than 50 years will cause the most challenge to your Lordships. He will discover that we float figures around the House like confetti to justify whatever position we happen to take. Happily, this usually goes unchallenged, yet with my noble friend in place I suspect that we will need to be on our mettle and to expect robust scrutiny in the future.
As my noble friend said, it has not been necessary to use the powers in the regulations and their removal is warmly welcomed. Although the regulations are concerned with the requirements under the Mental Health Act 1983, this debate inevitably raises wider issues in relation to mental health provision during the pandemic and beyond.
We know that the pandemic has had a significant impact on the country’s mental health and well-being. What is the Minister’s assessment of this and what measures are being taken to restore services and deal quickly with the backlog of patients? Does he agree with the assessment of Scientists for Labour that there has been a stark decline in the availability of services? Research by Mind from May 2020 reported that the restrictions on seeing people, being able to go outside and worries about the health of family and friends are the key factors driving poor mental health. The Centre for Mental Health predicts that at least half a million more people may experience a mental health problem as a result of the pandemic. Does the Minister agree?
As part of the lockdown in March, dramatic changes were made by NHS mental health services, including discharging patients from in-patient community services and moving to online provision. Has the impact of that been measured? Does he accept that eye contact often plays an important role in cognitive behaviour therapy? We need to reflect on that before assuming that services can always be online in the future. Will the Minister agree to publish a comprehensive plan to restore levels of service, including a thorough assessment of what changes in demand for services are arising from the pandemic?
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, the noble Baroness, Lady Warsi, has withdrawn from the debate and so I call the next speaker, the noble Baroness, Lady Fox of Buckley.
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.
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.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
The Grand Committee stands adjourned until 5 pm. I remind noble Lords to sanitise their desks before they leave the Room, and to vote, should they wish to do so.
Covid-19 Update
Baroness McIntosh of Hudnall Excerpts(3 years, 5 months ago)
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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.
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
Baroness McIntosh of Hudnall ExcerptsMonday 26th October 2020
(3 years, 6 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-III(Rev) Revised third marshalled list for Grand Committee - (26 Oct 2020)
Baroness Sheehan (LD) [V]
My Lords, is a pleasure to follow the noble Lord, Lord Alton. I agree with every word of his contribution, which is no surprise; I am usually in agreement with him.
I wish to speak briefly in support of Amendment 8, in the names of the noble Baroness, Lady Thornton, and the noble Lord, Lord Hunt, and to add my voice to support other amendments in this group. Amendment 8 would amend the wording at the start of Clause 1(2) to read
“the appropriate authority must act with a view to ensuring”.
This offers greater purpose of intent on the part of the Government of the day than the existing
“the appropriate authority must have regard to”.
It would strengthen the Government’s responsibility to their citizens over the safety and availability of human medicines, as well as the attractiveness of parts of the UK for clinical trials, et cetera, however that attractiveness is defined. I look forward to the upcoming debate on that issue with interest. It would of course also strengthen the duty of the Government of the day to ensure fair access to medicines, as per Amendment 19, which will be debated later and is in my name and that of my noble friends Lady Jolly and Lord Sharkey, and the noble Lord, Lord Alton, who I always think of as a friend.
It goes without saying that I strongly support all amendments relating to the report of the noble Baroness, Lady Cumberlege. Finally, I lend my support to Amendment 59 in the name of the noble Baroness, Lady Bennett. Animals cannot speak for themselves yet they are sentient beings. Their welfare should be our concern.
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.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I have received one request to speak after the Minister, from the noble Lord, Lord Hunt of Kings Heath. Once we have heard from the noble Lord, I will try one more time to establish contact with the noble Baroness, Lady Jolly. However, I have to tell the Committee that so far we have not been successful.
Lord Hunt of Kings Heath (Lab)
My Lords, I thank the Minister for his response. Could he say a little more about the Government’s overall patient safety strategy? He is saying essentially that the Bill is confined to medicines and medical devices regulation, yet underlying the concerns of the noble Baroness, Lady Cumberlege, is the fact that patient safety has not been gripped. In a sense, he has given a technical response. We will come to more specific amendments relating to, say, a patient safety commissioner, but at some point it would be interesting to get an insight into government thinking about patient safety more generally.
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.
Baroness Thornton (Lab)
I thank the Minister for his reply and all noble Lords who took part in what has been a worthwhile, interesting and sometimes rather impassioned debate.
The Minister is probably being slightly optimistic in thinking that we will not attempt to implement as much of the report of the noble Baroness, Lady Cumberlege, in this legislation as we can, because we are not sure when the next Bill where we could do so will come along. He might think about that. A little while ago, we had a Bill that would have been perfect for this report’s purposes but, unfortunately, we never got any further than Second Reading.
I thank the noble Lord, Lord Sharkey, for his support as we have moved through slightly difficult times in the past few days. The noble Baroness, Lady Cumberlege, knows that she has our support for the recommendations in her amazing report. We will do everything that we can from this side of the House to make progress.
The noble Baroness, Lady Bennett, is quite right to remind us of the fact that we are dependent on animals for making sure that our medicines are safe. We should never forget that.
My noble friend Lord Hunt was quite correct when he said that patient safety needs to be central. In fact, my noble friend’s remarks reminded me of the time when I was number two to the noble Lord, Lord Darzi, when he was a Minister in the House. He was absolutely passionate about patient safety and how it could be implemented. He also made a coherent argument for the fact that you could ultimately save money if you got patient safety right from the broad GP level all the way through to the implementation of new drugs and so on.
The remarks from the noble Lord, Lord Patel, were a tour de force. They illustrated again to us, if we did not already know, that his experience and knowledge are of enormous use to the Committee.
The noble Lord, Lord O’Shaughnessy, was doing a balancing act, saying “Ooh, attractiveness, ooh, patient safety, how is that going to work out?” He started off by saying that there should not be a trade-off but I think that he might have come to the conclusion that there will be one.
Between them, the noble Lord, Lord Kakkar, and the noble Baroness, Lady Watkins, brought enormous wisdom to this discussion. Both of them were balanced in the way that they expressed the need to put patient safety at the centre of the Bill.
The Minister and my team and I need to discuss the difference between “having regard to” and “with a view to ensuring”. The two things are not the same; this is not just about semantics. We probably need to have that discussion between now and the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
We now come to the group beginning with Amendment 14. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 14
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, the next speaker was to have been the noble Baroness, Lady Jolly. I am afraid we have not been able to establish a connection with her, so I call the next speaker, the noble Lord, Lord Lansley.
Lord Lansley (Con)
I want specifically to refer to Amendment 16 in this group, which is in my name and that of the noble and learned Lord, Lord Woolf. The purpose of that was prompted by looking at subsection (2)(c), and this question of attractiveness, or
“the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines.”
In this particular instance, we concluded that while one might think that the United Kingdom was, or was not, an attractive place to supply human medicines and derive certain conclusions from that, the process of medical innovation is not well captured by a simple reference to clinical trials. The process of medical innovation is a wider set of factors than clinical trials alone. In particular, I think that in our minds, in looking at the United Kingdom, one of the underlying strengths of the United Kingdom as a place in which to develop medicines is because of our strengths in discovery.
For example, I remember as a resident of and former Member of Parliament for South Cambridgeshire that my constituency included the Laboratory of Molecular Biology which, among its other attributes, is the single research institute with the largest number of Nobel prizes in the world. The strength of discovery is an absolutely central aspect of the fact that AstraZeneca, Cancer Research UK and Addenbrooke’s and Papworth hospitals are close by and the biomedical campus at Cambridge is bidding to become Europe’s single strongest location for life sciences. If you delved back over the last 50 years and asked what the distinguishing characteristic of that was, you might well say Cambridge University—and people would well understand that—but you might equally say the Medical Research Council’s Laboratory of Molecular Biology and all that went with it. This is not because the LMB does clinical trials; it is because it does discovery. I think our intention was to say that, if the medicines regulator is having regard to these factors, maybe it should have regard to discovery as well.
I entirely take the point that perhaps, where the medicines regulator is concerned, discovery is something that happens before it really gets involved. However, if it is thinking about the environment for life sciences, I find it very hard for it to think about it in parts, and not as a whole. That is what Amendment 16 is intended to explore.
There is another question conveyed by a number of these amendments, which, as my noble friend the Minister has quite rightly highlighted, is this interesting use of the word “attractiveness”. I may well have regard to the attractiveness of many things, but that does not necessarily mean I do anything about it. That the Minister has brought forward his own amendment to point to
“the likelihood of the relevant part … being seen as an attractive”
place is very interesting and takes us much closer to where we want to be. However, it still begs the question of what the medicines regulations should require the regulator to do about it, having had regard to this thing. There are other amendments which, I think, perfectly properly raise the question of whether the regulator should seek to enhance the attractiveness of the United Kingdom as a relevant place, et cetera. I think it raises a very interesting question. I get the impression that the Minister is trying very hard to move to the right place; I am just raising the question of whether we are quite there yet without something like the word “enhancing”.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, before I call the next speaker, I should just inform the Committee that we now know that the noble Baroness, Lady Jolly, is unwell, and will therefore be unable to take part in the remainder of today’s proceedings. In due course, no doubt, we will know who will take her place in subsequent groups. I call the next speaker, the noble Lord, Lord Hunt of Kings Heath.
Lord Hunt of Kings Heath (Lab)
Can I just follow the noble Lord, Lord Lansley? Clearly, we are going to continue teasing out “attractiveness”. I have no doubt that I want the UK to be attractive in terms of the development of medicines and medical devices, and I think the noble Lord, Lord Lansley, was absolutely right when he paid testimony to the underlying strength of our medical innovation and discovery, and indeed the life science sector as a whole. I think one of the questions we are going to consistently talk about is that we do have a problem with the attitude of the National Health Service to those very medical innovations that take place in this country. As I will touch a bit on procurement, I should declare an interest as president of the Health Care Supply Association, because clearly it is involved in procurement decisions.
As I think was discussed in the first day of Committee, the ABPI has reported that for every 100 European patients who can access new medicines in the first year, just 15 UK patients have the same access. It is a major problem that we are so slow to take advantage of developments in new medicines and devices, both in our country and globally. We are seeing in the NHS essentially an unprecedented level of rationing, both locally and nationally. My own view is that NICE has developed into more of a rationer than it was ever intended to be. Locally, clinical commissioning groups are making almost perverse decisions, ranging from cutting out health promotion programmes to being very restrictive on some operations or, again, on access to innovative drugs.
Of course I understand that the drugs budget cannot be open-ended, and the NHS must achieve value for money. But the fact is that we are at great risk of losing our place at the top table when it comes to medicines and medical devices innovation, despite the excellence of the people we have, which the noble Lord, Lord Lansley, referred to. At the moment, I think we have developed around 14% of the top 100 global medicines, but 20 years ago it was 25%, and the risk, of course, is that we go lower and lower.
Similarly, in relation to access to devices, we have a very innovative devices sector, but again it is utterly frustrated by the NHS’s record in adopting innovation. Its suppliers are forced to battle against a fragmented marketplace—they lack a clear route to market—budget silos that impact on buyers’ ability to release savings directly, and a short-term focus on cash-releasing savings at the expense of longer-term benefits. As an example, I was approached by the Urology Trade Association, which represents the suppliers of the majority of urology projects to the NHS, which pointed out that, in normal times, urinary tract infections are the greatest single cause of unplanned hospital admissions, so it has a big impact on quality and duration of life and on use of NHS resources. If we were prepared to invest in improved devices, it could have a major benefit. But essentially, whatever the Government say about procurement and value-based procurement, they always go for the lowest price, and I am afraid that we often buy the lowest-quality products.
The ABHI has told me of one company in the dialysis sector which now sees the UK as a second or third-tier sector, due to the prices it commands here. I know that on the first day of Committee the noble Lord said he cannot talk about reimbursement; the problem is that Ministers will never talk about reimbursement. It is interesting that, in general, if we are increasing staff—the numbers of doctors and nurses—I think Ministers tend to proclaim that as a good thing. However, increased budgets in devices and medicines is a shock, because the whole philosophy of his department and the NHS is to hold down the budget.
The problem is that, essentially, we do not invest in the great things that are happening. It is naive to think otherwise. There are a lot of things we can do to encourage the kinds of things that are happening in Cambridge—through tax incentives, for example, and schemes for faster access—but they relate only to a few selected medicines and devices. Overall, we are at great risk. I am afraid that the NHS has to face up to some responsibility for that, both in terms of the industry, and in terms of patients. Why should we in this country have to wait so long for medicines that in other European countries are available much sooner? This is a major issue which we need to tackle.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I call the next speaker, the noble Lord, Lord Patel. Lord Patel? Oh dear, we are not having a great afternoon. If we cannot establish contact with the noble Lord I will move on to the next speaker. Lord Patel, are you with us?
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I am sorry. We could not hear you and we still cannot see you.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
Ah! You are with us in all your glory. Please continue.
Lord Patel (CB) [V]
Not much glory, but thank you very much.
Before I talk about the amendments I intended to speak to, I want to comment on the amendment tabled by the noble Lord, Lord Lansley, and the comments that the noble Lord, Lord Hunt of Kings Heath, just made, which I absolutely agree with.
The noble Lord, Lord Lansley, is right about innovation. It should be part of the Bill, together with clinical trials. As he rightly said, we are a nation that excels, and has done for more than 20 years, in discovery science, particularly in biology and molecular biology. He mentioned Nobel prizes: the United Kingdom has won 29 Nobel prizes in medicine and physiology, and 29 in chemistry, two subjects often linked with discoveries in biology.
However, as the noble Lord, Lord Hunt, said, we are poor at taking the biology forward into innovations and drug development. We have some fantastic universities for drug development, but for that they require a strong allegiance with the NHS. The science base needs to be integrated with our NHS and its data, including patient data, to develop drugs. That is what we lack. He is absolutely right. I hope that we will have another opportunity to address this matter. Are our policies on how drugs are procured and assessed holding us back? That is a good debate to have, and it is a pity we are not having it today.
I have already said that I support Amendment 16, in the name of the noble Lord, Lord Lansley; I also support Amendment 20, in the name of the noble Baroness, Lady Thornton, to which I have added my name. I shall also speak to my own amendments—Amendments 21, 61 and 82—which are supported by the noble and learned Lord, Lord Mackay of Clashfern, who could not be with us because he is in the Chamber.
With regard to government Amendment 14, I have said before, and I repeat now, that the construction is open to the interpretation that the attractiveness of the UK is to be treated as part of what promotes public safety. If so, the amendment would not address—indeed, it would appear to prevent—the argument being made that attractiveness and the safety of medicines and medical devices can sometimes be in conflict. The consideration of attractiveness can undermine the consideration of safety. This is in line with the Government’s repeated assertion that attractiveness is never in conflict with safety.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, I understand that the noble and learned Lord, Lord Woolf, who was due to speak next, is not with us this afternoon. I am saying this very slowly in case he is, but I do not think so. In that case, I call the next speaker.
Baroness Watkins of Tavistock (CB) [V]
My Lords, I support Amendment 20 in the name of the noble Baroness, Lady Thornton, to which I have added my name. Its purpose, together with Amendment 21 in the name of my noble friend Lord Patel, who has just spoken so eloquently in favour of it, are to provide a definition of attractiveness for clarity and the primacy of safety, while maintaining an environment that promotes the UK as a centre for global life science research and innovative working with academic partners in all continents across the globe. In addition, Amendment 20 should ensure that the UK population has prompt access to new medicines once they have been approved in line with Her Majesty’s Government’s philosophy for the future.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
That was commendably brief. I call the next speaker.
Baroness Masham of Ilton (CB) [V]
My Lords, in supporting Amendment 61 and the others in this group, I declare an interest as I have a farm and I often use vets, who supply veterinary products and medicines. I must say that vets have been exceedingly careful and all precautions have been taken that have been put in place for protection over Covid-19. The Veterinary Medicines Directorate protects animal and public health and the environment. This needs our support, which this amendment provides, as it ensures that safety remains a priority.
In recent years, over half the veterinary surgeons who register in the UK each year have qualified elsewhere in the EU and the EEA—38.5% from the UK, 52% from the EU and EEA, and 9.5% from other countries. Free movement of people has had an enormous impact on our veterinary workforce. Additional barriers to the movement of EEA-qualified vets to the UK will have significant consequences for animal health and welfare, public health and trade. If understaffing happens, it will become a safety issue. Some 95% of the veterinary workforce in abattoirs graduated overseas, mainly from the EU. This information comes from the British Veterinary Association. Does Regulation (EU) 2019/6 on veterinary medicinal products aim to make more medicines available in the EU to treat and prevent diseases in animals through simplifying our procedures for obtaining a marketing authorisation and reviewing incentives for breakthrough medicines? The Bill provides the means to make “corresponding or similar provision” to both regulations. Will the Minister give an assurance that that will happen? It is a safety issue and very important.
To make the UK an attractive place to do research and development, the much-needed bright people coming from abroad should feel wanted and safe. It is time that the UK realises that we cannot achieve the high standards that we want without help from others in veterinary science. We should be welcoming and kind to each other. I hope that the Minister will help to prioritise safety in this important Bill. I send my best wishes to the noble Baroness, Lady Jolly, and hope that she gets better soon.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
My Lords, we now come to the group beginning with Amendment 17. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 17
Medicines and Medical Devices Bill
Baroness McIntosh of Hudnall ExcerptsMonday 19th October 2020
(3 years, 6 months ago)
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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.
Lord Hunt of Kings Heath (Lab)
My Lords, I support the two amendments in the name of my noble friend Lady Thornton. I have also put my name to Amendment 22 from the noble Baroness, Lady Finlay—she is currently in the internal markets Bill Second Reading debate—which links this to a definition of attractiveness, and to Amendment 39 in the name of the noble Lord, Lord Patel, which focuses on clinical trials for rare diseases and the importance of alignment with the European Medicines Agency.
At the end of this debate, I hope we will have a better idea of the Government’s approach to the regulation of medicines and medical devices. I do not want to repeat myself, but, as my noble friend said, the big question seems to be that at the moment the EMA covers 25% of global pharmaceutical sales and the UK on its own makes up 3%. We know that the NHS is a very poor customer in terms of adopting new medicines. The UK market is pretty hopeless for pharma. If we are not going to be aligned to the EMA, what will this mean for UK pharma in terms of future investment? My guess is that it will snap off that investment.
This is the big issue, which we do not yet understand. What is the Government’s aim? Is it the idea that a no-deal Brexit is a good thing and UK pharma will survive with a hopeless home market and all the problems of dealing with Europe? Countries will clearly not come to the UK first when they have the EMA next door, unless we offer fast-track licensing, which brings us back to patient safety, which is why the two link so much together.
I hope that this time the Minister will give us some idea of what the Government are aiming for. The same applies to medical devices, although there are some specific opportunities, because at the moment the MHRA has no involvement in the pre-market phase of medical device development. Is the intention that the UK develops a proactive regulatory role for devices that is more akin to the licensing of medicines? If so, what will be the implications for industry and patient safety? Clearly, there have been many issues about medical devices in the past which have not gone through such a robust regulatory regime. Is it the intention that the UK goes through a more extensive regime in the future under its own steam? What will the general implications be?
Again, we know that Covid-19 is having an impact on clinical trials, a significant number of which have been paused. It is my understanding that only 45% of studies are currently open to recruitment and only 36% of them have successfully recruited patients since 1 June. The ABHI has highlighted the need for a sustainable plan and aims to return clinical research to pre-pandemic levels by spring next year.
This is important because, despite the size and growth of the global market for clinical research, the UK’s share of clinical trial applications and patient recruits has fallen since 2016. The UK is now falling behind the US, Germany and Spain for phase 3 commercial clinical trials. What is to be done about that? What is the Government’s approach? Again, how does this relate to the future regulation of clinical trials?
I hope that the Government’s intention is to stimulate the UK’s clinical research environment, but part of that must be enabling multi-state UK-EU trials to continue. The idea that we can have multi-state trials that do not involve some agreement with the EU seems fanciful in the extreme. Again, at this stage, we are entitled to know from the Government exactly what they intend.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
I call the noble Lord, Lord Sharkey.
The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)
Could the noble Lord please unmute his microphone?
Lord Sharkey (LD) [V]
Can you hear me now? Yes? Good. Noble Lords will be relieved to hear that I will not start again. I will speak to Amendments 34, 36 and 37.
Clause 4 deals with clinical trials, which delivered £1.5 billion in GVA and £335 million to the NHS in 2018-19. They are an absolutely critical part of UK life sciences and part of what makes the UK a global leader in medical research. Anything that reduces the number or share of clinical trials in the UK weakens that leadership and could delay access to new drugs or treatments.
In its briefing, the APBI points out that our share of clinical trial applications and patient recruits has fallen since 2016. As the noble Lord, Lord Hunt, said, we now rank behind the US, Germany and Spain for phase 3 trials—and Covid has had a dramatic effect. The University of Southampton has published research showing that 1,500 clinical trials of new drugs and treatments for cancers, heart disease and other serious illnesses have been permanently closed down in Britain, with a further 9,000 suspended.
The Government know all this and acknowledge the importance of clinical trials. Given that, Clause 4 is a surprisingly weak response. It does not require the Government to do anything at all. It simply says that they may regulate—it does not say how they may regulate—and lists the areas in which they may regulate. This is another example of the abuse of secondary legislation. It gives unspecified policy-changing powers to Ministers without saying what these policies might be, except that they should do no harm—not a very demanding qualification.
When questioned about this and asked which bits of the CTR they will carry across, the Government’s response is, “The elements that are in the UK’s best interests.” These best interests are to be identified after consultation with interested parties. This all seems unnecessarily feeble. Researchers, commercial and academic, need certainty and stability as soon as possible. Ideally, they would like the provisions of the new UK regime to incorporate all possible provisions of the CTR as they come into force. We know what these provisions are. We know all the thinking behind them. The UK played a central part in their construction in the first place. Our amendments try to give some clarity and certainty to the situation.
Amendment 34 would replace “may” with “must”. It would oblige the Government to do something and does not just give them the power to do something if they feel like it. Substituting “must” for “may” would mean that the Government must make provision corresponding or similar to provision in the CTR.
Amendment 36 would modify this requirement slightly to acknowledge that we cannot adopt certain provisions of the CTR. These are the provisions that relate to the EU clinical trials information system and the assessment model involving co-ordinated decision-making on multi-state trials. Amendment 36 would add “where possible” to the requirement to make provision corresponding to or similar to provision in the CTR to allow for this.
Amendment 37 specifies two features of the CTR that the Government must incorporate. These are specified because they are new and very important, and for the avoidance of doubt about the meaning of “corresponding to” or “similar”. The two new features are the new definition of clinical trials and the allowing of co-sponsorship. In its briefing, CRUK notes that the MHRA has had considerable input in the new definition of clinical trials. It notes in particular that the new definition expands the scope of low-risk trials and excludes altogether some studies, such as pure pharmacology studies that are focused on how medicines work rather than on the extent to which they do. The CTR also defines and allows co-sponsorship, where two or more sponsors across multiple countries may share responsibilities. CRUK regards this as a very positive move, allowing for more flexibility in trial set-up and helping to foster collaboration. We helped to design both these new features. We should ensure that they are incorporated into our new regulatory regime.
Coronavirus Act 2020: Temporary Provisions
Baroness McIntosh of Hudnall Excerpts(3 years, 7 months ago)
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Lord McColl of Dulwich (Con) [V]
My Lords, first, I congratulate the noble Baroness, Lady Clark of Kilwinning, on her maiden speech, and am so pleased to know that she is from my favourite island, the Isle of Arran, on which I spent many a happy holiday during the war. I also congratulate my noble and learned friend Lord Clarke of Nottingham on his maiden Speech. I am so glad to have him here. I have always been very grateful to him, because he allowed us to reopen a little hospital in the East End, the Mildmay Mission Hospital. I think his civil servants had told him, “On no account are you to let them have it”, but he did, and for that we are very grateful.
Many of the critics of these measures seem, as has been mentioned, to be unaware that many of them use the powers of the Public Health (Control of Disease) Act 1984, as amended, including local lockdowns, national social distancing rules and travel restrictions. The Coronavirus Act 2020 is a bit different, in that it supports services to do with the public health response to the pandemic, provisions that support the furlough scheme and very successful changes in the Courts & Tribunals Service. The 2020 Act enables Her Majesty’s Government to respond effectively to changes in the pandemic, such as making it easier for people to receive their statutory sick pay. In a recent survey, 63% of the people of the UK considered that these measures did not go far enough.
The Deputy Speaker (Baroness McIntosh of Hudnall) (Lab)
The noble Lord, Lord Birt, has withdrawn from the debate, so I call the next speaker, Lord Randall of Uxbridge.
Mental Health Services
Baroness McIntosh of Hudnall Excerpts(3 years, 11 months ago)
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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: Social Care Services
Baroness McIntosh of Hudnall Excerpts(4 years ago)
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Baroness Wheeler
My Lords, I thank all noble Lords who have participated in this excellent and powerful debate. I thank the Minister for his thoughtful response, but however thoughtful it was it is clear that many questions remain unanswered and that we will need to ensure that they continue to the brought to the fore and be dealt with by the Government in future Questions, Statements, debates and legislation.
Noble Lords have stressed the need to be open and honest about the challenges that social care faces and about the good and bad news. I am sure the Minister will take that message to heart. Despite the challenges, I want to stress that it is truly heartening to know that this terrible disease has at least been a wake-up call for the Government and the public about the importance of adequate social care for millions of adults and children in need of it and about the value, respect and decent pay that the 1.4 million staff deserve and must be given.
The Deputy Speaker (Baroness McIntosh of Hudnall) (Lab)
My Lords, it is a privilege to be the first—I think—to put the question in a virtual Chamber that this Motion be agreed.