Debates between Lord Bethell and Baroness Thornton during the 2019 Parliament

Wed 26th Jan 2022
Health and Care Bill
Lords Chamber

Lords Hansard - Part 1
Wed 26th May 2021
Mon 26th Apr 2021
Wed 21st Apr 2021
Tue 9th Mar 2021
Tue 2nd Feb 2021
Medicines and Medical Devices Bill
Lords Chamber

Consideration of Commons amendments & Ping Pong (Hansard) & Ping Pong (Hansard): House of Lords
Thu 21st Jan 2021
Medicines and Medical Devices Bill
Lords Chamber

3rd reading & 3rd reading (Hansard) & 3rd reading (Hansard): House of Lords
Thu 14th Jan 2021
Medicines and Medical Devices Bill
Lords Chamber

Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Wed 13th Jan 2021
Tue 12th Jan 2021
Tue 12th Jan 2021
Tue 12th Jan 2021
Medicines and Medical Devices Bill
Lords Chamber

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tue 5th Jan 2021
Thu 19th Nov 2020
Medicines and Medical Devices Bill
Grand Committee

Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Tue 17th Nov 2020
Medicines and Medical Devices Bill
Grand Committee

Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Wed 11th Nov 2020
Wed 11th Nov 2020
Medicines and Medical Devices Bill
Grand Committee

Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wed 4th Nov 2020
Medicines and Medical Devices Bill
Grand Committee

Committee: 4th sitting (Hansard) & Committee: 4th sitting (Hansard): House of Lords
Wed 28th Oct 2020
Medicines and Medical Devices Bill
Grand Committee

Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Mon 26th Oct 2020
Medicines and Medical Devices Bill
Grand Committee

Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Tue 20th Oct 2020
Mon 19th Oct 2020
Medicines and Medical Devices Bill
Grand Committee

Committee stage & Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords
Wed 16th Sep 2020
Tue 8th Sep 2020
Mon 20th Jul 2020
Wed 8th Jul 2020
Wed 8th Jul 2020
Mon 22nd Jun 2020
Wed 20th May 2020
Thu 14th May 2020
Wed 25th Mar 2020
Coronavirus Bill
Lords Chamber

Committee: 1st sitting (Hansard) & Committee: 1st sitting (Hansard): House of Lords & Committee stage
Wed 25th Mar 2020
Coronavirus Bill
Lords Chamber

3rd reading & 3rd reading (Hansard) & 3rd reading (Hansard): House of Lords
Mon 9th Mar 2020
Thu 23rd Jan 2020
Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I an enormously grateful for this debate, because this clause and related clauses are critical both to achieving the digital transformation aims of the NHS, referred to by the noble Lord, Lord Clement-Jones, and to getting the healthcare system to work better together.

I am also grateful for the humanity and testimony of several noble Lords, exemplified by the noble Baroness, Lady Finlay, who spoke movingly about the practicalities of patients going to see their doctors. I know from my own life and from my family how important it is to protect those relationships.

That is why I would like to hear a little from the Minister about what protections there are, because health data is and should be treated as a special category of data. What additional protections are there in the use of health data, including in the common law duty of confidentiality, the role of the National Data Guardian, the way the Caldicott principles will be used and the national data opt-out? What reassurances do we have that those special considerations will apply to this clause and its related components?

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, I agree with my noble friend Lord Hunt and those speakers who expressed their concern about the open-endedness of what is in the Bill at the moment and the lack of protection for patient data. I look forward to the Minister’s reply on this.

NHS: Hospital Visiting

Debate between Lord Bethell and Baroness Thornton
Wednesday 15th September 2021

(8 months, 2 weeks ago)

Lords Chamber
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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, it is a question of balance. We certainly have to be extremely careful about people visiting those with Covid because of the obvious contagiousness of that disease. As I said, the guidance is currently to limit the size of groups to one close family member, but we are mindful of the mental health impact of that, so trusts are trying to get the right balance between contagion control and the mental health implications of people being ill and alone in hospital.

Baroness Thornton Portrait Baroness Thornton (Lab)
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It is very nice to see the Minister in his place; I wish him good luck right now. May I say how much we welcome the measures relating to visits in care home premises from 16 August? Welcoming anyone into care homes poses risks and it is important that those risks are managed and mitigated. In the face of the winter plans that have been announced, is there any expectation that there will be a review of these guidelines for care homes under plan A or plan B?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am pleased to say that 91% of care homes in England have been able to accommodate residents receiving visitors, compared to 40% in March. That is huge progress and answers a very large amount of concern that I have heard here in the Chamber. It is our objective not to change or review these measures. We want to try to keep care homes open to visiting in a safe way, as we do presently. If it becomes necessary, though, we will take the steps to protect life.

Commonwealth Fund Report: NHS Ranking

Debate between Lord Bethell and Baroness Thornton
Tuesday 14th September 2021

(8 months, 2 weeks ago)

Lords Chamber
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Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, we are very grateful to the Commonwealth Fund, based in America, for its very important report and its updated rankings. I note that the criteria in the report have changed considerably over the years. On the report’s key points, I agree that there is more that we can do on patient equity. The Government have put health inequality at the centre of their agenda, and we are working hard on implementation. On care process—the other key finding of the report—we do not recognise the report’s analysis.

Baroness Thornton Portrait Baroness Thornton (Lab)
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Well, how convenient. The UK’s drop in rank in the Commonwealth Fund’s five-yearly research into the performance of the world’s wealthiest 11 countries’ healthcare systems from first to fourth still seems to be associated, as the noble Lord has said, with access to care and with equity. This is important because the key differences between the top-performing countries, of which we are still—just—one, and the worst performing healthcare systems, of which the USA is, by a long way, the outlier, concern universal coverage, removal of cost barriers, investment in primary care systems, reducing bureaucratic burdens and investment in social services, particularly for children and working-age adults. Can the Minister explain to the House how the announcement on social care last week and the current NHS reform Bill before Parliament will contribute to the UK’s healthcare performance and ranking in the next five years?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the noble Baroness half answers her own question. When it comes to universal coverage, I am extremely proud of the NHS and the service that we provide to the British public. There is no other health system like it anywhere in the world. The report makes cogent points on equality, and we have put that at the centre of our agenda, and in the NHS long-term plan, the prevention Green Paper and the newly implemented Office for Health Improvement and Disparities. We are doing that work through the obesity plan, the NHS health checks, the tobacco control plan and the vaccination plan. We are highly committed to this agenda, and we are making an impact.

Flu Vaccination and Blood Test Cancellations

Debate between Lord Bethell and Baroness Thornton
Tuesday 14th September 2021

(8 months, 2 weeks ago)

Lords Chamber
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Lord Bethell Portrait Lord Bethell (Con)
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As my noble friend knows extremely well because of her close connections with the industry, GPs and pharmacies are responsible for purchasing their own flu vaccines through the seasonal flu vaccination programme, directly from manufacturers or wholesalers. Deliveries are phased and typically take place over a long period from September to November. As I said earlier, the disruption we have had in the supply was from one supplier for one or two weeks. It has not had a meaningful impact on the supply of flu vaccines to this country.

Baroness Thornton Portrait Baroness Thornton (Lab)
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The Minister and the Government need to catch up with what is going on on the ground. I think almost everyone in your Lordships’ House knows someone who has had their flu vaccine appointment cancelled. There are two such noble Lords over there. I know three people in the House whose flu vaccinations have been cancelled. Perhaps he needs to go back to have another look at this.

The BMA has called for a COBRA meeting on the shortages of test tubes and transport. The Minister might think it is scaremongering, but it actually has a right to be alarmed. First, in these circumstances, if there are further delays and shortages, will he and the Government have a system of prioritisation? Secondly, how will the NHS encourage better take-up of flu vaccination among NHS staff?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I hear loud and clearly the very obvious feedback from noble Lords about cancelled appointments. It is not the same as the guidance that I have been given, but I will look into it when I get back to the department and will be happy to write to the noble Baroness with an update on them. With regard to test tubes, I reassure her that guidance was issued to the NHS and GPs recommending actions for medical directors, nursing directors, GPs and pathology laboratories. It required refinements that had an impact, but those with an acute need for blood were accommodated and a COBRA meeting was not needed.

Health Protection (Coronavirus, Restrictions) (Steps etc.) (England) (Revocation and Amendment) Regulations 2021

Debate between Lord Bethell and Baroness Thornton
Tuesday 14th September 2021

(8 months, 2 weeks ago)

Grand Committee
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Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, I thank the Minister for introducing this late regulation. As I said to him last week, there is a sort of “Groundhog Day” tendency in having to deal with these things. I would also like to register with the noble Baroness, Lady Barker, that the House needs to address the issue of the noble Baroness, Lady Brinton, being able to access these sessions in the same way that she can access the Chamber. I would even go so far as to say that it is discriminatory that she cannot. As well as that, we are missing her wisdom, words and her representation of her points of view.

The noble Baroness, Lady Barker, and my noble friend Lord Hunt have covered many of the points and have asked many of the questions that need to be asked on this regulation. As noble Lords have said, it triggers the end of most of the lockdown restrictions in England by revoking regulations and amending regulations listed in the schedule from 19 July. I echo what other noble Lords have said. Does the Minister believe that it was premature to remove face mask regulations? I have not yet read the 30-odd page toolkit document in full, so I do not know whether the option is there to reintroduce them as part of the autumn-winter Covid plans. Would that be mandatory?

At the time of lifting the restrictions, from these Benches we opposed and still oppose the decision to remove the requirement to wear a face covering indoors and on public transport. The risk of transmission inside a crowded bus or train will be high. If it is true, as the scientists say, that one in 70 of us in England has Covid, and the capacity of a double decker bus is about 70 and a full Tube train or regular train carriage can carry up to 140 passengers, that would mean that on average one person on a crowded bus and two people on a crowded Tube train will be contagious. They will have Covid, and with little ventilation and no legal requirement to wear a mask.

I travel on public transport all the time—it is how I get to your Lordships’ House and go home—and it is certainly noticeable that mask-wearing, particularly among young men, has fallen. It is true that on the Tube there are marginally more people wearing masks than on the Overground, but the number has fallen. It is very concerning and worrying, and I have got to the point where I have stopped being a mask monitor and offering people masks if they have not got one on, because there are too many of them on the Tube and on trains without masks on.

We supported the removal of restrictions on gatherings, but we thought the Government were going too far and too fast at the time. We were also concerned that the lifting of all the restrictions was confusing to businesses. Has the Minister had feedback about how effective the lifting of those restrictions was? This instrument extended the expiry date of the Health Protection (Coronavirus, Restrictions) (England) (No. 3) Regulations to the end of September to ensure that local authorities retain the power to respond to local serious and imminent public health threats as a result of the spread of coronavirus. Can the Minister confirm whether the Government intend to further extend these provisions? If it is in the winter plan I apologise, but I think we will be discussing that tomorrow or Thursday.

I suspect that the winter plan contains which bits of the Coronavirus Act are being retained and which will be got rid of. However, what worries me is whether in three or four weeks’ time, if infection rates have increased enormously as a result of the schools going back, there will be sufficient powers to deal with that, and sufficient powers if we need to go into further restrictions. The Minister must explain what will happen if the worst happens. The byword throughout the whole pandemic has been “Let’s plan for the worst and hope that we don’t have to use those powers.” If all those powers are being rescinded now, what will we do if there is a new variant further into the winter or we see a spike in the next three or four weeks? We need to know that.

In terms of mask wearing, I went on holiday to Scotland by train and it is true that as we neared the border, there was an announcement that everybody had to wear a mask, and everybody put a mask on. It was not an issue. Like the noble Baroness, Lady McIntosh, I do not regard mask-wearing as an encroachment on my civil liberties. I regard it as something that protects me and with which I protect others. We seem to have lost that message in the wearing of masks. Are the Government going to do anything about that?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I thank noble Lords very much for an extremely helpful debate, and I very much welcome this return to the Moses Room. It is very nice to be back in the intimate and more conversational style of Committee.

The Secretary of State has been on his feet this afternoon to talk about the toolkit. My understanding is that there will be some kind of Statement repeat, and I look forward very much to going through the toolkit during that. I apologise in advance if I cannot answer every question on that right now, but I would like to tackle a couple of points that were raised. Before I do, I will say a word of appreciation for the contributions of the noble Baroness, Lady Brinton—her presence is highly valued—and for those who organised the virtual House and our current arrangements. It is all a massive compromise and uncomfortable, but I am extremely grateful for the work that has been done to make this return possible. I am hopeful that even more can be done in October.

A number of noble Lords, particularly the noble Lord, Lord Hunt, asked about the booster. The NHS will be rolling out a booster programme to protect those who are most vulnerable to Covid, as we announced previously. It will now be extended to individuals who received vaccination in phase 1 of the programme: that is, JCVI groups 1 to 9. That includes those living in residential care, all adults over 50, front-line health and social care workers, and all those aged between 16 and 40 who have underlying health conditions that put them at a higher risk of severe Covid.

This is very good news. There is very strong evidence that a booster programme such as this can have a very big impact, particularly on those who are immunosuppressed or who live with the immunosuppressed. The JCVI has advised that the booster vaccine programme is offered no earlier than six months after completion of the primary vaccine course, and that will of course affect many people. The vaccination programme has been planning booster vaccinations for some time, which means that the NHS is now in a position to offer booster doses from next week. As most younger adults will have received only their second Covid vaccine dose in late summer, the benefits of booster vaccination in this group will be considered at a later date. I think noble Lords would agree that this is a reasonable and proportionate approach to this complex issue.

NHS: Nursing Workforce

Debate between Lord Bethell and Baroness Thornton
Wednesday 8th September 2021

(8 months, 3 weeks ago)

Lords Chamber
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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, as my noble friend will know, the training grant of at least £5,000 per academic year per eligible student is in place, plus a further £3,000 of additional targeted funding—for example, for childcare costs and students studying special subjects. That is the kind of financial commitment that we have made to meet his concerns. On the specific point that he mentioned, I say that not everyone is suited for the nursing profession; it is a really tough job, and not everyone who wants to be a nurse can be a nurse. I am afraid that the applications that we get and the sifting that we do reflects that point.

Baroness Thornton Portrait Baroness Thornton (Lab)
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I draw attention to my interests at Whittington Hospital in the register. Thank goodness that our nurses are incredibly resilient, but the relentless nature of working for the NHS, not just in the last year but prior to the pandemic, is now taking its toll. That includes senior and experienced nurses; there must be a worry that many could take early retirement, which is a risk to the profession. The feedback that I get, to which noble Lords have referred, is that respect and regard is less evident as the pandemic continues, and I think that is exacerbated by the debate about pay. What other initiatives is the NHS considering to deal with the fragile nature of retention—for example, housing offers, travel and the working environment—and will they be funded?

Lord Bethell Portrait Lord Bethell (Con)
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The points that the noble Baroness makes are entirely right, and we share exactly the same concerns. That is why we have put in place mental health support, enhanced occupational health support, expansion of the right to work flexibly across the NHS, and the promotion of equality. On the point about older nurses, two things particularly stand out: there is significant investment in leadership through the NHS Leadership Academy, and we have bespoke support for over-50s and newly qualified nurses, recognising that they are likely to be the biggest flight risk across the NHS.

Animal Diseases: Future Pandemics

Debate between Lord Bethell and Baroness Thornton
Wednesday 21st July 2021

(10 months, 1 week ago)

Lords Chamber
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Lord Bethell Portrait Lord Bethell (Con) [V]
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My Lords, the “one health” approach is moving through the G7 process at the moment. I am not sure whether a precise timetable exists. I am happy to check to see whether dates are available, and I will write to the noble Baroness accordingly.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, it is quite clear that the health and scientific world has, not surprisingly, been focused on the pandemic. The FAIRR report published today and previous reports in this area show what a threat to world health there is from antimicrobial resistance. The question is: how much of a priority is this in the Government’s work? I think that is what most speakers have asked. How much money is the department investing in this area this year and in the next five years?

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

Debate between Lord Bethell and Baroness Thornton
Tuesday 20th July 2021

(10 months, 1 week ago)

Lords Chamber
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Lord Bethell Portrait Lord Bethell (Con) [V]
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My Lords, I thank the noble Baroness, Lady Thornton, for her support for the regulations in the round, for her supportive words about the role of the private sector in the round and for raising many important points in her amendment to the Motion, stressing the vital role of NHS testing as we continue to manage the pandemic.

I want to clarify that these regulations are not connected to the future of free NHS testing. This SI, as noble Lords have noted, is solely focused on ensuring the quality of any Covid test in the UK and that they are of the same standards as I would procure for the NHS.

It is self-evident that poor-quality tests, when used privately, could pose a risk to the health of not only the individual but the public. All that is necessary for entry of Covid test products into the UK market is controlled by EU CE marking, which, as noble Lords noted, is currently a self-declaration process for most Covid-19 tests on the UK market. The performance declaration made as part of this EU marking does not need to be independently verified ahead of sale of such tests. There is no legally binding agreed process for establishing performance. That just is not good enough. It became clear as I sought to procure tests at scale for the national effort that many kits that had passed a CE mark were not fit for the real world. I say to the noble Lord, Lord Hunt, that it is not right that the quality of tests correlated to any particular nation; this applied to all nations.

I say to the noble Lord, Lord Alton, that we have audited the supplies of medical devices and there are no current slavery or human rights concerns. We do, however, remain vigilant. I regret that his question on sourcing has not been answered, particularly because there is a very large amount of public material on the procurement framework, the suppliers to it and the arrangements we make to run that framework. I will address that gap with speed, and with regret.

I reassure the noble Lord, Lord Scriven, that there is a very large amount of published material on the internet on the validation of tests, including the protocols and the results from Oxford University and Porton Down, which conducted the validation of the tests. These validation protocols have been assessed by a very large number of experts, and I would be glad to send him links to the protocols and the assessment processes. I reassure him that our tests have been tested against alpha, beta, gamma and delta variants and successfully detect all of them.

The noble Lord, Lord Alton, referenced “kickbacks” to the Communist Party. I very kindly and respectfully ask him to remember that British officials have operated a remarkable procurement programme during the pandemic at the very highest standards of integrity. I gently ask him to provide evidence for such accusations before making them in the House.

To the question of why we buy so many tests from China and not from Britain, the simple answer is that they pass our protocol and meet the requirements of the procurement framework regarding quantity, speed and product design, for example. We buy them to ensure a good deal for taxpayers and effective tests for the public.

I completely agree with the noble Lord, Lord Hunt, that we need a strong UK manufacturing base. I reassure the noble Lords, Lord Alton and Lord Scriven, and others who have raised this point that we have a major programme on this, with subsidies, expertise and support available. I would be glad to arrange a briefing session to run noble Lords through all the measures we have in place to support the UK diagnostics industry. I believe the high-quality regulations we are discussing today provide the certainty business and investors need to invest in the UK diagnostic system. We need this market to provide additional capacity at the time of the pandemic, to ensure that we have outstanding testing capability while also encouraging innovation.

I was keen to take an evidence-based approach to developing this policy, so we ran a very successful consultation that had a broad range of respondents. Some 73% agreed that mandatory validation of tests prior to entry to the market was the best approach; 88% of those agreed that this should be legally backed; 71% agreed that a validation process would not significantly reduce supply; and 79% agreed that mandatory validation processes will increase safety.

In April this year we launched the universal testing offer, so now anyone in England can access free LFD self-tests by ordering online or collecting then at over 9,000 pharmacies across the country. To reassure the noble Baroness and all noble Lords concerned about this, our recently published road map out of lockdown made it clear that we are keeping in place key protections, including free testing for people with symptoms, but we are standing down the workplace testing regime, as the noble Baroness, Lady Thornton, rightly pointed out, from 19 July.

On the rationale for regulation, I welcome the support of the noble Baroness, Lady Thornton, for NHS tests, which have always been of the highest standard. The objective of the legislation is to ensure that the same high standards for tests that we see upheld when the Government buy them are equally reflected in the testing market for all consumers. That market already exists in this country; over 1,000 providers are already going through the UKAS accreditation process. These tests are being used to enable activity across many areas of the economy, including travel, film, TV production and sport. It is critical that we put in place processes to ensure that these tests are high quality and accurate: that is what this law does.

On the integration of private tests and the NHS test and trace system, I reassure the noble Lord, Lord Scriven, and the noble Baroness, Lady Thornton, that significant work has already successfully linked private sector testing results with the NHS Covid app, the JBC and test and trace. When a test is conducted by a testing provider, whether public or private, the result of that test, whatever the outcome, is legally required to be reported to PHE as a notifiable disease by the provider. To the noble Lord, Lord Scriven: this is true for a private test or a public test, and I would be glad to send him a copy of the long-standing regulations that make this law. This must be done within 24 hours for all positive tests. Any self-administered test provided by the Government can be reported via our online portal by members of the public. Any positive test reported to PHE will be passed on to our contact tracing system.

The draft impact assessment has now been published in the interest of transparency, as has an impact statement. It is a living document, and we want to make the best analysis available. We intend to update the impact assessment and address the RPC’s comments ahead of the introduction of the second SI in the autumn. I would like to put on record my thanks to the RPC for working so closely with us and at such pace on this matter.

I want to ensure that all tests are available in the UK, whether they are offered by the NHS, a charity or a private provider, and whether they are supplied by a British diagnostic firm or an overseas firm. I thank the noble Baroness for giving me this opportunity to respond to her important points. I beg to move.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, I start by thanking the Minister. I feel for the Minister, and I wish him well in his self-isolation, and I congratulate him on his immediate and unfussy decision to obey the ping and the trace system. I hope he is going to have a great summer, because I think he has earned it.

I thank the noble Lords, Lord Hunt, Lord Alton and Lord Scriven, for their support and the questions they have asked. I apologise to the House that we did not put this amendment down in the first place. It should have come straight to the floor of the House rather than going through the Grand Committee first. It was only the gathering concern in Committee that led me and other noble Lords to the conclusion that we needed further discussion about this.

It is not up to the noble Lord, Lord Alton, to prove the veracity of the sources of any goods we purchase through the NHS or anywhere else. If it is being bought by the Government, it is up to the Government to demonstrate that those supply lines are not exploitative and do not use slave labour. That is part of the transparency we are calling for. I do not think the Minister answered very well on that matter.

I am concerned that workplaces, as I suspected, will now have to pay for the testing regime we have. I am somewhat reassured by the noble Lord assuring us that tests have to be fed in through the test and trace system wherever they happen, but I am concerned that, given that workplaces will now have to purchase all those tests, the system will break down quite quickly over the summer. We still have many questions and regrets, so I wish to test the opinion of the House.

Hospital Waiting Lists

Debate between Lord Bethell and Baroness Thornton
Tuesday 29th June 2021

(11 months ago)

Lords Chamber
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Lord Bethell Portrait Lord Bethell (Con)
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Surgical hubs are exactly the kind of interesting and progressive medical developments that we need to embrace to get through the backlog; in fact, that kind of specialism creates a huge amount of efficiency for the system and a better service for patients. We are working hard to understand how we can use them more effectively, and I would be glad to write to my noble friend with any details we have on the progress that we are making.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, the Royal College of Radiologists tells us that 62,000 patients were waiting six weeks or more for a CT or MRI scan, and there may be as many as 45,000 missed cancer diagnoses. There are terrible shortages of skilled staff, fewer scanners than the majority of comparable countries in the OECD—we have half the number in France and a third of the number in Germany—and about a third of our scanners are obsolete or nearing obsoletion. Given the huge waiting list catch-up that the NHS faces, these diagnostic facilities are absolutely vital. Will the Government provide the necessary investment to address this urgent challenge—and in what timescale?

Lord Bethell Portrait Lord Bethell (Con)
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I agree with the noble Baroness that diagnostics is one area where this country needs to make further investment. In the 2020 spending review, we ring-fenced £325 million of capital spending to support NHS diagnostics; the funding will be spent on new equipment, digitising NHS imaging and the pathology networks. New capacity is also coming through the new community diagnostic hubs and pathology and imaging networks. This work is critical, and we are working hard to make sure that it is effective.

Covid-19: Proof of Vaccination

Debate between Lord Bethell and Baroness Thornton
Monday 14th June 2021

(11 months, 2 weeks ago)

Lords Chamber
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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I apologise for not being clearer; I will be crystal clear right now. Today, you can have a digital certificate on your iPhone, you can have a digital certificate that is printed out from your computer or you can call a number and have a paper certificate sent to you in the post immediately. All of those options are live today.

Baroness Thornton Portrait Baroness Thornton (Lab)
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Disability campaigners are deeply concerned about the integration of health data into cultural participation and worry that the Government’s plans to set up the vaccine passport scheme could undermine the rights of disabled workers and audiences who cannot have the vaccine because of a health condition. What steps are the Government taking to ensure that any scheme that is introduced obeys the seven key inclusive principles, including complying with the Equality Act in making reasonable adjustments to ensure that disabled people do not face discrimination?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am very alive to the concerns of the disabled. We have to balance the need to limit the spread of this virus to save lives, but in a way that is fair and just to all people. We are very much engaged with disability and other charities to ensure that that works. The noble Baroness is right that there will be some people for whom the vaccine does not work and who could yet catch the disease. We need to make provision for those people, and we are working on that.

NHS Digital: Primary Care Medical Records

Debate between Lord Bethell and Baroness Thornton
Tuesday 8th June 2021

(11 months, 3 weeks ago)

Lords Chamber
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Lord Bethell Portrait Lord Bethell (Con)
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The nature of the data is very explicitly described in the documents that the noble Baroness will have referred to. If she likes, I would be very happy to send her a full set of details. Of course, many patients have engaged with the process and, like the noble Lord, Lord Young, have made the wise decision to remain enrolled in the system.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, my honourable friend Jon Ashworth called for this delay yesterday in the Commons. It is not often that we can say thank you to the Minister at such short notice, but it is very welcome that the Government have agreed to this delay. The eighth Caldicott principle—I assume that the Minister is aware of the principles—makes it clear that it is important that there are no surprises for the public around how confidential information about them is used. If GP data can be used by a third party, be they public or private, how will that principle be fulfilled?

COVID-19 Variant: Travel Guidance for Local Authorities

Debate between Lord Bethell and Baroness Thornton
Wednesday 26th May 2021

(1 year ago)

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Baroness Thornton Portrait Baroness Thornton
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To ask Her Majesty’s Government what plans they have to ensure local authorities are informed of new travel guidance on areas where the COVID-19 variant B.1.617.2, first identified in India, is spreading.

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, we are always looking to see how we can communicate more effectively with local authorities. We will have discussions with local authority colleagues this week to make sure that everyone is clear what the expectations are and how we can improve communications going forward.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, to paraphrase Matt Lucas as the Prime Minister: “Don’t go to work—go to work. If you can stay indoors, go outside. Don’t go outside—go on public transport. Don’t go to work and then—something or other will happen.” It would be laughable if it were not so serious. I have two questions for the Minister. The amended guidance asks people to minimise travel into and out of the eight hotspot areas. The previous version asked them to avoid all non-essential travel. What is the difference between those two things or is it like the amber countries—you can go there but you should not? If the Government want people to heed their advice, guidance or instructions, why were the notices posted on a website during the night without consultation or accompanying dissemination to people and organisations such as public health, councils and mayors? That does not seem the most effective way to communicate with people.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the characterisation presented by the noble Baroness is unfair. We are trusting people to be responsible and to act with caution and common sense, as they have done throughout this pandemic, and to make decisions on how best to protect themselves and their loved ones. We are seeking to avoid bringing these measures into law and instead are using guidance. The communication of that guidance could have been done better but we are working extremely hard with regional partnership teams, Public Health England, local authorities, JBC colleagues and the incident management teams to ensure that these communications are done in the most effective way possible.

Covid-19

Debate between Lord Bethell and Baroness Thornton
Wednesday 26th May 2021

(1 year ago)

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Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, we can probably all agree that the Minister has drawn the short straw today—and not for the first time, I think.

The issue I want to raise on this Question is that the Government took powers in the road map legislation to impose local lockdowns, so I ask the Minister: are any discussions taking place about whether those powers will be activated in those areas? Secondly, we know that a single dose of the vaccine is less effective against this particular variant, so I repeat the question asked earlier: what plans are there to increase vaccination in the areas most affected by the spread of the Covid variant B16172? Will the Government produce a plan with the local directors of public health to roll out the vaccines to everybody in those areas, and consider including bringing forward a second dose for a larger cohort of people?

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, the noble Baroness asks two very pertinent questions which slightly answer themselves, in a way—but let me try to update the House on our plans in that area. She is right that we have powers on local lockdowns, but that is not the focus of our thinking at the moment. Local lockdowns are an important tool, but not one that we think is a priority right at this moment. We are focused on the vaccines. It is beyond doubt that this Indian 2 variant particularly hits those who are not properly vaccinated—and by “properly” I mean “have had two doses and two weeks”. Those who have forgone either their first or second dose are particularly vulnerable, and you have only to look at the infection data and, particularly, the hospitalisation data to understand that.

That is why we have rolled out surge vaccination in those areas. What that means is a huge amount of communication, a huge amount of engagement with the communities and the presence of various mobile vaccination units sent directly into the heart of the communities to provide different channels and mediums by which people can step up for their vaccine. The response has been extremely strong and I am touched, as I have said, by the videos of people in some of those communities, particularly in Bolton, where people have queued up for their vaccines. I pay tribute to the DPHs and local authorities that have facilitated that programme.

Osimertinib Cancer Treatment

Debate between Lord Bethell and Baroness Thornton
Tuesday 18th May 2021

(1 year ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, we estimate that there are currently just eight patients in Northern Ireland who would benefit from the expanded use of Tagrisso for early-stage disease. Perhaps I may reassure my noble friend that they will all have the same access as in the rest of the United Kingdom without any delay or restraint on that access.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, we should all wholeheartedly welcome the news of the agreement to enable early access to Osimertinib for early-stage lung cancer patients in England and I absolutely recognise that it is also available to patients in Northern Ireland. However, early diagnosis is as important as access to treatment. It is therefore deeply concerning that the number of people in England and, presumably, across the UK being seen by a specialist for suspected cancer, following urgent referral from their GP, has dropped dramatically. What steps are the Government taking to bring those waiting lists down? We certainly cannot wait for a reorganisation of the NHS, as proposed this year. Does the noble Lord acknowledge that reorganisations tend to have a chilling effect on the recovery of our NHS?

Lord Bethell Portrait Lord Bethell (Con)
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The noble Baroness is entirely right to be concerned about the backlog of oncological diagnostics. It is of grave concern to all of us. That is why the NHS has massively prioritised the tests she described. We are working extremely hard to get through the backlog. GPs are extremely focused on identifying those most at risk and those who are late for their tests are being followed up with great energy and endeavour. I pay tribute particularly to the role of NHS D, which is using the kind of data gains that we made during the pandemic to mobilise all the technology we can to get the right people into tests at the right time.

Eating Disorder Services: Referrals

Debate between Lord Bethell and Baroness Thornton
Monday 17th May 2021

(1 year ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, undoubtedly, the increase in referrals is something of concern. It is something we are monitoring closely, with the round table and the ministerial group dedicated to looking at this. That shows the seriousness with which we regard it. The reduction in the impact of community services, which is the best way of addressing these kinds of issues, has undoubtedly had an effect on urgent needs. During this period, there has also been a large increase in the number of young people who have started treatment, which is encouraging. If the noble Baroness has evidence that measures such as nutrition information on packaging has an effect on anorexia, I would welcome correspondence from her.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, as the noble Baroness has said, we know that eating disorders among children and young people have increased during the pandemic. There is a very welcome increase in the grant of £11 million from the grant in 2018-19. Despite this, total spending by CCGs on children and young people’s community eating disorder services increased by just £1.1 million, from around £54 million in 2018-19 to £55 million in 2019-20. This increase is cancelled out if you adjust for inflation, and this means that total spend flatlined in real terms. What are the Government going to do to ensure that this money is spent on what is growing into an epidemic of eating disorders and the suffering they cause?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the noble Baroness is entirely right that community eating disorder services are critical. They are the backbone of our measures to address these difficult cases. But money for the treatment of eating disorders comes from many different pots. During 2021, a total of 10,695 children and young people started treatment, which is up from 8,034 children in the year before. So, clearly, resources are getting through to cope with a large number of people, and that is an encouraging sign.

Office for Health Promotion

Debate between Lord Bethell and Baroness Thornton
Thursday 29th April 2021

(1 year ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, there is already considerable co-ordination between the department, DCMS and DfE on exactly that. I highlight the money that has gone from the tax on soft drinks to contribute to funding outdoor activity in schools, which has had an enormous impact. My noble friend is entirely right that physical activity is linked to better health outcomes; that is why it will form part of the agenda for the Office for Health Promotion.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, the policy paper does not reference the measures proposed in the childhood obesity plan and the recent Tackling Obesity strategy released last July. I hope that omission is not significant. Can the Minister confirm—I was slightly concerned by his response to the noble Baroness, Lady Jenkin—that the ban on online adverts for foods high in fat, sugar and salt has been watered down? In awaiting the consultation from the advertising industry, is that a “whether” or a “how”?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, consultations are there to have an honest conversation. It would be wrong for me to try to pre-empt the outcome of that consultation from the Dispatch Box.

Northern Ireland: Flight Passengers and Covid-19

Debate between Lord Bethell and Baroness Thornton
Wednesday 28th April 2021

(1 year, 1 month ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I recognise the challenge to which the noble Lord refers. It is, of course, a fact that coronavirus restrictions in Northern Ireland are determined by the Northern Ireland Executive as part of the devolution settlement, as I am sure he would recognise. The Secretary of State for Northern Ireland has raised the issue with the Irish Foreign Minister on a number of occasions to press for a resolution, and while the UK Government continue to work closely with the Executive to drive this virus down, we respect that healthcare is a devolved matter. This is a complex issue to resolve, but we are extremely grateful to all parties who are working hard to resolve it.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, the truth is that the Northern Ireland Health Minister, Robin Swann, found out that there were cases of the Indian variant of the virus in the Republic of Ireland only from media reports. This is deeply concerning, as was raised by the noble Lord, Lord Dodds. Northern Ireland is part of the UK, so we have the same responsibilities to our fellow citizens in Northern Ireland and therefore it is very concerning. Is the Minister confident that, going forward, mutually beneficial data-sharing processes are in place to ensure that new variants are controlled and do not become seeded and spread in any of our communities?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am enormously grateful to the Irish Government for the very large amount of informal clinical data-sharing that goes on. CMOs of both countries exchange data on such matters as VOCs the whole time, and that kind of day-to-day clinical exchange of on-the-ground information works extremely well. The specific question of travel information is a lacuna that needs to be closed, I recognise that it needs to be shut, a lot of work is going on to shut it and I am grateful to those involved.

Folic Acid

Debate between Lord Bethell and Baroness Thornton
Monday 26th April 2021

(1 year, 1 month ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I would be glad to take the noble Lord’s recommendation back to the department; he puts it extremely persuasively. As I said, we have looked at the substantial point closely and it is extremely persuasive, as the noble Lord rightly put it. We hope to come forward with recommendations as soon as the elections are over.

Baroness Thornton Portrait Baroness Thornton (Lab)
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I reinforce what my noble friend Lord Rooker said. I may be addressing this with my third or fourth Minister. I am not certain whether the noble Earl, Lord Howe, dealt with it when I was opposite, but he may have done, which would make the noble Lord my fourth Minister on this issue. It is even more irritating that it was research in the UK that led the United States and other parts of the world to adopt this policy. I think The Minister has run out of road on this one, and I would like to hear what the timetable to implement this policy is.

Lord Bethell Portrait Lord Bethell (Con)
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I completely endorse the tribute of the noble Baroness to those who have worked on this policy. She is right: the science that has gone into this has been persuasive around the world. I thank those in industry who worked with us on our pilot, which proved extremely successful. We are in good shape when it comes to thinking through the implementation of such a policy. My hands are tied at the moment, because of purdah, but I hope to return and fulfil the noble Baroness’s wishes.

Covid-19: Obesity

Debate between Lord Bethell and Baroness Thornton
Wednesday 21st April 2021

(1 year, 1 month ago)

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Lord Bethell Portrait Lord Bethell (Con)
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As the noble Lord rightly points out, the cost is enormous: £27 billion is the estimated cost to society, and 64% of people are classified as overweight. The challenge is enormous. We have to strike the right balance between government action and personal agency. The noble Lord is right that the return on investment is huge, but the Government cannot lose weight for people on their behalf. No amount of government initiative will shed the pounds. We have to get people to change their behaviours. We are trying to understand what the right measures are to give people the inspiration and information they need to take the right steps.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, this Government’s proposal is the 14th government obesity strategy since 1992. Despite 689 policies having been introduced in the past 29 years, obesity rates have increased. Another major indicator is deprivation. Children from deprived areas are twice as likely to be obese as children from the richest areas, as acknowledged by the Government’s strategy. However, the strategy was criticised for not going far enough on poverty. Healthy foods are three times more expensive per calorie than less healthy foods. Can the Minister address this grave and vital matter of people from lower socioeconomic backgrounds not having access to, and being unable to afford, healthy and nutritious food?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I agree with the correlation pointed out by the noble Baroness. We must acknowledge and address the fact that areas of deprivation undoubtedly have higher levels of obesity. However, we have to be careful about taking away people’s sense of agency. It is possible to buy affordable healthy foods at any price point. Food has never been cheaper than it is today. We must put into people’s hands the knowledge and inspiration to take the steps necessary to shed the pounds that need to be shed.

Covid-19: Resuscitation Orders

Debate between Lord Bethell and Baroness Thornton
Wednesday 24th March 2021

(1 year, 2 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, we will address the audit points made by the noble Baroness. I completely endorse the importance of training; that is at the heart of the report and we acknowledge its importance. We are concerned about the number of people with learning disabilities who have died during the pandemic, and there will be a report on what the connections are.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, we know that it is unlawful for DNACPRs to be imposed, and I wonder why the research has not sought to identify why physicians and care workers continue to impose them in the way that they have. Does the Minister agree that the solution must lie in completely clear, unambiguous policy to advance care planning and DNACPR decisions, and a consistent use of accessible language, communication and guidance to enable clear understanding by commissioners, providers and the public?

Lord Bethell Portrait Lord Bethell (Con)
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I will gently push back against the noble Baroness: the policy is absolutely crystal clear. Blanket DNACPR is not the policy of this Government, as was repeated time and time again in our communications, which I would list if I had more time. Training is the issue: we need to give the front-line workforce the skills it needs to apply these very delicate but critical interactions. That is the recommendation of the report, and that is where we are focused on applying the lessons.

Covid-19: Government’s Publication of Contracts

Debate between Lord Bethell and Baroness Thornton
Thursday 11th March 2021

(1 year, 2 months ago)

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Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, the Minister will be aware that 100 contracts remain unpublished, while those that have been published are so heavily redacted that it is impossible to ascertain whether the orders reflect value for money for the taxpayer. Procurement guidance, which is still in force, says that once the contract is commenced, most of the contact details should be released and that only detailed pricing arrangements should be redacted and not much else. Indeed, Cabinet Office guidelines say:

“The government is committed to greater transparency across its operations … This includes commitments relating to public procurement.”


Can the Minister explain to the House and propose how meaningful transparency can be achieved to give effect to the Government’s stated policy?

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, with regard to the publication of contracts, the number of contract award notices that have been published is 609 out of 609. For contract finder notices, it is 892 out of 913—97.7%—and of the redacted contracts to which the noble Baroness refers, it is 792 out of 913, which is 86.7%. That is an enormous proportion of the contracts that exist that have already been published. The redaction is utterly according to Cabinet Office guidelines. I encourage the noble Baroness to have a look at them; it is remarkable how much detail there is in those contracts as they are published.

World Health Organization: Pandemics

Debate between Lord Bethell and Baroness Thornton
Tuesday 9th March 2021

(1 year, 2 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, we are extremely hopeful for the IPPPR process, and we have supported the team in its desire to get to the bottom of its investigations. I do not know the specifics of the bat viruses to which my noble friend refers, but I reassure him that the British Government are leaning on the WHO as hard as we possibly can to make the most of this important investigation.

Baroness Thornton Portrait Baroness Thornton (Lab)
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Given the cuts to the aid budget which have been announced, and given that experience shows that the world’s reaction to pandemics is to panic and then forget—which Covid-19 has cruelly exposed—can the Minister expand on how HMG are going to support the World Health Organization to address the immediate urgent work to fight the pandemic and to build for the future the firepower and structure to better handle an issue of global magnitude under the Government’s current budget constraints?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the financial support of the WHO from the Government is generous, and so is our support of COVAX. When it comes to the WHO, we are looking for stronger horizon scanning and early warning, higher-quality technical guidance that is tailored to different countries and resource settings, and greater co-ordination of governance and activity across the animal, human and environmental interface. This is a really clear manifesto. The Prime Minister has laid it out clearly, and we are using the G7 process to ensure that there is support for it across the G7 countries.

NHS: Pay

Debate between Lord Bethell and Baroness Thornton
Tuesday 9th March 2021

(1 year, 2 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I completely endorse the right reverend Prelate’s point about the heroics of—and the debt that we owe—nurses, but I just cannot agree with him that the best way of recognising the contribution of nurses is to give them a pay increase. That simply is not my experience of workplace engagement. Yes, pay rises are important and a recognition of work done, but there are other, much more important reasons why people work. They work for the status of that role, for the opportunities that it gives them in their life, for the security that it gives them and for the collaboration of working with fellow members of staff. There is a whole package of reasons why people do the work that they do. We live in extremely economically challenging times. It is right that the advice given to the pay review body looks at the entire package, not just at the pay increase.

Baroness Thornton Portrait Baroness Thornton (Lab)
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The Minister is quite right: it is not just about the 1% rise. A newly qualified nurse will earn £21,000 in 12 months; that is their starting salary. The consultants building the track and trace system, at £7,000 an hour, earn more than that amount in under four hours. Perhaps that will help the Minister understand why so many people are outraged at the proposed 1% so-called pay rise. Will he explain to the House what values and priorities he holds that lead him to believe that the Government’s decision is an acceptable one?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the noble Baroness makes some vivid comparisons on completely incomparable pay differentials. The values that we have are absolutely aligned with public service values. We are determined to create a workplace that is just, fair and equitable. We are committed to giving people a fair reward for the work that they do and to giving people decent job prospects within that role. Those are the values that people go to work for and are motivated by. We need to put together a package that works across the piece and is not narrowly focused on one particular material point, such as pay. I stand by what I said previously: the package of measures that was put in our evidence to the pay review body sees all those values in the round.

Independent Medicines and Medical Devices Safety Review: Sodium Valproate

Debate between Lord Bethell and Baroness Thornton
Tuesday 2nd March 2021

(1 year, 2 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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I am grateful to the noble Baroness for her tribute to my noble friend Lord O’Shaughnessy, who has done an enormous service to us all by championing this cause, both as a Minister, when he moved this review and made a huge impact, and since then with his patient and thoughtful advocacy of this important cause. He speaks very movingly and thoughtfully, and we are greatly influenced by his persuasion on this subject. The noble Baroness should be reassured that we are absolutely looking at the recommendations for a redress agency, and we will come back with considered thoughts on it when we answer the review in the round. Until then, I welcome all thoughts and advocacy on the subject.

Baroness Thornton Portrait Baroness Thornton (Lab)
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I have two points. First, last summer only 41% of the respondents taking valproate said that they had signed an annual risk acknowledgment form, so I would like the Minister to reflect on the fact that some GPs are not doing the job that they should be in terms of protecting women. Secondly, those affected by thalidomide and contaminated blood have a redress scheme, but it took years for that to happen. We simply cannot wait years for this to happen for those suffering from the effects of sodium valproate.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I welcome the noble Baroness’s point on the proportion of those who say they have filled in the form. Phase 1 of the registry is a helpful collection of statistics, but we are putting in place phase 2, which will help us to understand exactly how many patients who are taking sodium valproate have actually filled in the form. That will give us the concrete reassurance that we seek on this matter. I recognise that there are redress payments for thalidomide and contaminated blood, but redress payments are not necessarily suitable for every single misfortune that happens in the medical world. However, we will look very carefully at the case for sodium valproate and I take the noble Baroness’s comments on board.

Covid-19: Brazilian Variant

Debate between Lord Bethell and Baroness Thornton
Tuesday 2nd March 2021

(1 year, 2 months ago)

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Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, the challenge we have is uncertainty. Genomic sequencing data links the Brazilian variant to the South African variant, the so-called E484K mutation. We also acknowledge that there are anecdotes from Manaus on transmissibility, but none of this is clear cut. We are working towards getting the concrete data necessary to make a confident assessment of this mutation. Therefore, we are taking a precautionary approach and we are committed to limiting its spread by all means at our disposal.

Baroness Thornton Portrait Baroness Thornton (Lab)
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I thank the Minister. According to a report by the World Health Organization, the P1 variant that originated in Brazil has been found in at least 15 countries which are not on the Government’s red list, meaning that arrivals from those countries are currently exempt from the hotel quarantine policy. Virologists have warned that the Government’s red list is at risk of becoming out of date at any time because of the time it takes to sequence coronavirus cases. Indeed, these six cases date back to 11 and 12 February. In the light of these facts, and given concerns that the Brazilian variant may be more transmissible and might be resistant to existing vaccines, will the Government review the red list and take urgent action to introduce a comprehensive hotel quarantine system that applies to all UK arrivals?

Lord Bethell Portrait Lord Bethell (Con)
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The noble Baroness is entirely right: this is not the first case of P1 in Europe. As of 11 February, P1 has been identified in 17 countries, with 200 cases reported globally. In the EU, 30 cases have been identified in five countries and areas. We keep the red list under permanent review and have an ongoing process of keeping it up to date. The fact that we have a red list and a managed quarantine programme makes further expansion of the red list possible. It puts our borders and our vaccine under a programme where we can control things, which is to be applauded.

Covid Contracts: Judicial Review

Debate between Lord Bethell and Baroness Thornton
Monday 1st March 2021

(1 year, 2 months ago)

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Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, a year ago, Parliament gave the Government huge power so they could act quickly in the face of the pandemic. Unfortunately, growing evidence suggests that Ministers have taken advantage of these powers to the disadvantage of the taxpayer and to the cost of health workers and patients. The NAO report in November revealed that the Government set up fast-track systems for billions of pounds of contracts for people personally known to Ministers, Peers and MPs. They found that suppliers with links to politicians were 10 times more likely to be awarded contracts than those who had applied to the department in the normal way.

It looks like there is more to be explored here: not just a case of “delayed paperwork” as the Health Secretary has claimed but serious procurement rule breaches. Will the Government urgently publish the names of all companies awarded public contracts through the VIP lane and how much they were paid? What steps are the Government taking to recover millions of pounds of public money from companies which failed meet their contractual obligations?

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, I am grateful for the question from the noble Baroness, Lady Thornton. During those hectic days, more than 15,000 suppliers approached us. Many of them were credible, but many sadly were not. It was entirely right and the best practice to have a high-priority lane to triage and prioritise those who were the most credible. A sample of 232 suppliers in that lane reveals that 144 came from Ministers, 21 from officials, 33 from MPs and 31 Members of the House of Lords not in the Government—including many who chose to write to me personally with the names of recommendations. I am enormously grateful to those who got in touch.

Covid-19: Vaccination Programme

Debate between Lord Bethell and Baroness Thornton
Wednesday 24th February 2021

(1 year, 3 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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We have to work with what we have. The existing register, while not perfect, is the tool that we have for our task. GPs had been encouraged to update registers in advance of the vaccine, as we had several months of knowing that it was coming. I understand that considerable work has gone into that. With regard to carers, my understanding is that they are not currently included in the clarification that came out today, but I am happy to confirm that point with her.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, we all want our children back at school on 8 March, and the Government need to do everything possible to keep children learning, with testing systems that work, ventilation and the use of Nightingale classrooms. The Government missed the opportunity to vaccinate teachers at half-term, so I ask the Minister to explain why, if our children are to be back at school on 8 March. When will teachers and support staff be a priority for vaccination?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, teachers are a priority in as much as they are on the prioritisation list along with other key workers, but the honest assessment of the JCVI is that teachers are not at accelerated risk of increased sickness or hospitalisation over any other member of the public. We are enormously grateful to the teaching profession for the role it is playing in getting schools back and in testing but, in terms of sickness and mortality, teachers are in the right place in the JCVI prioritisation.

Food-related Crime

Debate between Lord Bethell and Baroness Thornton
Monday 22nd February 2021

(1 year, 3 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am across the recent outbreak of chicken nugget salmonella poisoning across the UK. However, I point to the work of the European distribution fraud unit, which is very much focused on this kind of cross-border food crime. I will take back to the department the noble Baroness’s recommendation and will write to her if there is any update that I can provide her with.

Baroness Thornton Portrait Baroness Thornton (Lab)
- Hansard - - - Excerpts

I will be very quick because I am very keen that the noble Lord, Lord Krebs, is able to get in on this Question. Can the Minister commit to briefing parliamentary counsel to advise and bring forward these changes, and when can that happen? We on these Benches would welcome this commitment and would give appropriate support to the resulting legislative process.

Lord Bethell Portrait Lord Bethell (Con)
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I am enormously grateful to the noble Baroness for her support in this matter. I reassure her that we are focused and working on it, and I will bring forward an update as soon as I reasonably can.

Dentists: Covid-19

Debate between Lord Bethell and Baroness Thornton
Thursday 11th February 2021

(1 year, 3 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I confess that I did not know about that association. I am not sure whether it is correlation or causation, but I completely support the noble Baroness’s observation that oral hygiene is critical, and we should put the steps in place to improve the oral hygiene of the nation.

Baroness Thornton Portrait Baroness Thornton (Lab)
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I think the Minister needs to go back to the drawing board, because the new NHS activity target is basically forcing dentists to choose between check-ups and helping those in pain. That cannot be right. It can only increase health inequalities, let alone deal with the gigantic pandemic backlog. In secondary care, there is the particular problem of patients needing general anaesthetic for their dental treatment. These are mostly children and learning-disabled adults. There was already a waiting list of a year before the pandemic. Could the Minister inform the House how many patients are on this waiting list now? If the Minister does not have this information, could he please write to me? Do the Government have a plan to reduce this awful, and obviously very painful, waiting list?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I do not necessarily accept the dichotomy the noble Baroness refers to. I think it is reasonable for dentists to triage patients between those who can be treated with either advice, analgesics or antibiotics, and therefore do not need face-to-face contact, and those who need to be prioritised to, for example, the urgent dental care centres. I commend the dental profession for making good choices in that area. With regard to the treatment of children using anaesthetics, those are not statistics I have to hand, but I would be glad to write to the noble Baroness with whatever information we have.

Covid-19: Self-Isolation

Debate between Lord Bethell and Baroness Thornton
Wednesday 10th February 2021

(1 year, 3 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, of course, employees should be working from home wherever possible, and that is why our focus has not been on this area to date. I emphasise that on Monday the community testing part of Test and Trace issued a call to all those employers of more than 50 employees where it will provide free testing kits for those interested in using workplace testing. This is going to be an essential part of our fight against Covid in the future, and we look forward to working closely with the CBI and other employer groups to make sure that the rollout happens efficiently.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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I am puzzled, because the studies by SAGE estimate that the levels of compliance were between 18% and 25% and that people earning less than £20,000 a year or who had less than £100 in savings were three times less likely to self-isolate. I repeat what other noble Lords have said: what plans do the Government have to fix statutory sick pay so that people who self-isolate have the proper financial support that they need? Also, how many people have applied for the £500 grant and how many people have been awarded it?

Covid-19: Over-75s

Debate between Lord Bethell and Baroness Thornton
Tuesday 9th February 2021

(1 year, 3 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the priority list from the JCVI indicates that all residents in care homes, older adults and those over 80 will be first. But, with the current state of the rollout, all those over 65 should have been offered a vaccine, and I encourage them all to step up and respond to the letter when they receive it.

Baroness Thornton Portrait Baroness Thornton (Lab)
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I would like to ask the noble Lord about domestic abuse. Next year, ONS data collection will, for the first time, include those aged over 75 who suffer from domestic abuse. That is an important step forward. However, the pandemic has meant that many older people at risk of domestic abuse are indeed isolated and at risk. So what steps are the Government taking to collect data on the impact of domestic abuse on over-75s during the pandemic and to ensure that appropriate support is in place for older victims and survivors?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the noble Baroness makes the point extremely powerfully. Of course, our prevailing feeling is of admiration for all those who have, through love and companionship, cared for those who are shielding or at home. But of course, as the noble Baroness alludes to, there are instances when, through either domestic tension or simple abuse, there is violence, and we cannot hide from that fact. I am not aware of a current trial or piece of research on this matter but I will take it back to the department and undertake to write to the noble Baroness with an update.

Medicines and Medical Devices Bill

Debate between Lord Bethell and Baroness Thornton
Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, I am very grateful to the Minister and his team for the manner in which they have engaged and worked with us throughout the passage of this Bill, particularly at this final stage. The amendment in lieu is a good compromise that reflects the need for scrutiny to be at the heart of the Bill. It provides a mechanism to examine the powers of the Act in five years’ time and will open the door for the restructuring and consolidation of the post-Brexit medicines and medical devices regulatory regime. We believe that this will prove both desirable and necessary, and look forward to working with the Minister on such issues when the time comes.

We welcome the requirement that the Secretary of State must specifically consider whether this should be in the form of primary or secondary legislation and hope that this will lead to policy being put into a future Bill rather than scrolled away in regulations. The Secretary of State will also have to take account of all parliamentary committee reports. This would include post-legislative scrutiny undertaken by a Select Committee, as well as the DPRRC and Constitution Committee, whose oversight played a crucial role in reshaping a skeleton Bill into a framework Bill; I thank the noble Lord, Lord Lansley, for explaining that to us all. I hope the Minister can assure me that stakeholders will also be consulted. I am sure that that will be the case. It is very important, given that they are the end users of the legislation, and for the report to have value and credibility it must reflect the experience of regulators, industry, patients and medical professionals.

Finally, the tidying-up amendment that retains the requirement to share information in the public interest is an important provision because it will allow for substantive and ethical issues relating to the sharing of public data to be considered. This is of the utmost importance, given the role that the NHS and patient data may have in future trade deals.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I do not intend to repeat much of what I said at Third Reading. Many thanks to the noble Lords who have contributed to the changing shape of the Bill. From Committee to ping-pong, we have listened, heard proposals for change and brought workable, practicable compromises forward.

I wish to repeat the remarks made by the noble Baroness, Lady Thornton. She congratulated all of us on the effective communication that has made it possible to make considered progress on this Bill, despite all the challenges that Covid-19 has presented us with. This a very fair assessment; I agree with it completely. From the report of my noble friend Lady Cumberlege to the demonstrated expertise of our medicines regulator, the MHRA, we have seen the importance of patient safety, clinical trials, our life sciences sector and effective regulation bear out in our hospitals, clinical trials and patient community.

I look forward to the debates ahead of us on the regulations that will be made under the Bill. They will be important, as we set forward on our course for the best possible regulatory regime for the UK, with the patient at its heart.

Covid-19: Vaccines

Debate between Lord Bethell and Baroness Thornton
Monday 1st February 2021

(1 year, 3 months ago)

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Baroness Thornton Portrait Baroness Thornton
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To ask Her Majesty’s Government what plans they have to ensure that the second dose of the Pfizer/BioNTech COVID-19 vaccine is delivered to patients within 12 weeks of receiving the first dose.

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, the second dose completes the course and is vital for long-term protection. That is why all patients will be offered a second dose between 77 and 84 days after receiving their first. We have already vaccinated almost 9 million people, with the ambition to reach the 15 million people in the most vulnerable groups 1 to 4 by the middle of February.

Baroness Thornton Portrait Baroness Thornton (Lab)
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I thank the noble Lord for his partial reassurance; however, the question is actually whether there will be a supply available in the timeframe. Given that any unvaccinated area provides a potential pool for new strains of Covid to develop and re-infect the world, extending immunisation to the whole world is not

“only a matter of altruistic engagement,”

but “of enlightened self-interest,” to quote Tony Blair. Does the noble Lord agree that countries must come together to reject vaccine nationalism in favour of co-operation? At what point in terms of vaccination of priority groups will the UK be able to make vaccinations available to other countries that are in need?

Lord Bethell Portrait Lord Bethell (Con)
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I completely agree with both the noble Baroness and the former Prime Minister Tony Blair on this matter. Not only must we vaccinate our own country, but we are not safe until the whole world is vaccinated. That is a basic public health and epidemiological observation. It is why we are very committed to international efforts—to CEPI, Gavi, COVAX and ACT. They are all working hard to get fair distribution of vaccines. We have also put £571 million into the funds at COVAX to support vaccines for the developing world. However, we have to start at home and it is not possible to make a commitment on the schedule for when we will be in a position to think about exporting vaccines until that is completed. When it is completed, I will update the House accordingly.

Medicines and Medical Devices Bill

Debate between Lord Bethell and Baroness Thornton
Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the Bill before us is quite different from the one we started with, but it is no doubt much better. That is entirely because of the huge value of your Lordships’ challenge and scrutiny. We have held over 50 meetings and considered 249 amendments, and the result is a tribute to the care and patience of noble Lords, for which I give profound thanks. It is also, if I may say so, a tribute to the workings of the hybrid House, which have kept legislation moving under difficult circumstances.

We would not have reached this position without the thoughtful, collaborative and constructive input of noble Lords, to whom, I pay tribute—in particular, to the noble Baronesses, Lady Thornton and Lady Wheeler, on the Opposition Front Bench, together with the noble Lord, Lord Hunt, and the noble Baronesses, Lady Jolly and Lady Walmsley, and the noble Lord, Lord Sharkey, on the Liberal Democrat Benches. I also thank, from the Cross Benches, the noble Lords, Lord Patel and Lord Alton, and the noble Baroness, Lady Finlay. They have all brought their immense experience and wisdom to our debates, to improve this legislation. And when it comes to wisdom and experience, I must also pay tribute to those from these Benches, especially my noble friend Lord Lansley, my predecessor, my noble friend Lord O’Shaughnessy, and my noble and learned friend Lord Mackay of Clashfern, who have all been of enormous help in enabling us to arrive at a consensus across the House. My noble friend Lord Howe has been a generous mentor, and my noble friend Lady Penn is a superlative Whip, both shepherding the process charmingly, discreetly and effectively.

I thank most emphatically my noble friend Lady Cumberlege. She has spoken of the importance of compassion, of the voices she has listened to, and of the paramount importance of patient safety. I have heard her, and I support her endeavour. She has the support of the House in her efforts, and we have collectively made significant progress towards her admirable goal.

I also thank officials on the Bill team, particularly Alice Clouter, and those in my private office, particularly Tilly McEwan. They have all worked tirelessly and expertly. I cannot give thanks to all the other champions in the House who have made influential interventions, but I am definitely very grateful to them.

I cannot hide my excitement about the future. While the Bill process is near its conclusion, we are at the end of the beginning of an exciting new regulatory system—a system that protects patients and enables innovation. It is with that vision of the future, as well as my gratitude to all, that I beg to move.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, at this stage of the Bill, we take a few moments to congratulate ourselves and thank those who have made it possible to get this far. First, I thank my own Bill team, who have worked so hard, particularly Rhian Copple in the Lords Opposition office, and my noble friends Lady Wheeler and Lord Hunt—and, indeed, my noble friend Lady Andrews and others, who popped up here and there to support us.

We should all congratulate ourselves because, despite the conditions in which we have worked this autumn and winter, we have managed to build effective communications which have made it possible to make considerable progress in improving the Bill in many ways, as the Minister said. I think we can say that we did our job, as the revising Chamber.

The fact that we ended up with only three Divisions on Report is a testimony to way in which the Minister, the noble Lord, Lord Bethell, his Whip, the noble Baroness, Lady Penn, and his adviser, the noble Earl, Lord Howe, and the very hard-working Bill team led by Alice Clouter, handled the Bill. They listened, they discussed, they considered and they revised, which is really all that one can ask. This is the Minister’s first Bill, and I congratulate him on leading his team and handling what is always a baptism of fire for any Minister.

I am delighted to agree with the Minister and say that we are sending back a very different, and much improved, Bill. We have managed to address many of the big-ticket items, ranging from data sharing to human tissue, and, ultimately, patient safety. I thank participants across the House. Like the Minister, I mention in particular the noble Lord, Lord Patel, the noble Baroness, Lady Jolly, the noble Lords, Lord Freyberg and Lord Clement-Jones, and the noble Baroness, Lady Cumberlege. I also thank everybody else who has taken part in the many discussions and given us the benefit of their wisdom, particularly the noble Lords, Lord Lansley and Lord O’Shaughnessy.

First Do No Harm paved the way for the creation of an independent patient safety commissioner, and I think that changed the way in which the Bill was handled, because it is now, as it should be, a patient safety Bill. For that, I really wish to congratulate the noble Baroness, Lady Cumberlege.

Finally, I want to thank the organisations who have given us their support and expertise, which is particularly important for those of us in opposition. I am very grateful to the DPRR and Constitution Committees for their insightful scrutiny, which sometimes is painful for the Government but is almost always helpful to us; the Lords Library; and, for us, the University of Birmingham, the British Dietetic Association, Advanced Accelerator Applications, the Association of British HealthTech Industries, Cancer Research UK and, in particular, the BMA. I am very grateful for the expert briefs that they have given us.

Stakeholder engagement will remain key for many years to come, for while the Bill will soon pass—as the Minister said—the task of creating a post-Brexit medicines and medical devices regulatory regime is far from finished. I look forward to working with stakeholders and the Minister to make sure that we move forward in the best possible fashion. We have given ourselves a good start.

Covid-19: Vaccination

Debate between Lord Bethell and Baroness Thornton
Wednesday 20th January 2021

(1 year, 4 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the noble Baroness puts her point very well. There is a huge amount of sympathy and concern for those who have underlying conditions, and she is right that ONS data on those with underlying conditions demonstrates a higher hospitalisation and mortality rate. That is why we have put all individuals between 16 and 64 with underlying health conditions that put them at a higher risk of serious disease and mortality higher up the prioritisation list than others. However, it is age more than anything else that is the greatest determinant of morbidity, and that is why the list looks the way it does.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, I would like to ask the Minister about those who are housebound and bedbound. If their domiciliary workers, care workers and unpaid carers are vaccinated in centres and with their GPs, what arrangements are in place for home visits to vaccinate this particular cohort of people, who cannot leave their home because of their disability or their particular conditions? It has been rumoured that there is no intention to vaccinate this cohort at present, which I find remarkable. So I would like the noble Lord to assure the House that arrangements are being made for this particular cohort.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I reassure the noble Baroness that it is absolutely not our intention to leave those who are housebound out of the scheme—not at all. In fact, they are an important priority. They are logistically a big challenge. We are in a numbers game. We are trying to get the greatest number vaccinated as quickly as possible. However, we are working extremely closely with community pharmacists and GPs to try to figure out the way in which we can get the vaccine to people who cannot make their own way to a vaccination centre. Those plans are in advanced progress. I do not have details of them to hand, but I would be glad to write to the noble Baroness with those details.

Health: Eating Disorders

Debate between Lord Bethell and Baroness Thornton
Tuesday 19th January 2021

(1 year, 4 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, NHS England is working with Health Education England to procure training courses that will increase the capacity of the existing workforce, to allow them to understand these challenging issues better and allocate people to the right course of treatment. It is a problem that we recognise, and resources in training are being put in place to address it.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, following on from the last question, hospital admissions for bulimia rose 75% during lockdown, amid fears about the mental health impact of the pandemic. For children and young people, we also know that these figures have been rising every year for several years. We also know that there are regional disparities in waiting times for eating disorder services. What will the Government do to respond to what seems like an increase in eating disorders and rising regional disparities?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I recognise the issue of regional disparities, but I reassure the noble Baroness that our ambition is to deliver swift access to treatment for 95% of children and young people with suspected eating disorders within one week. The good news is that in the second quarter of 2021, 83% of urgent cases were seen within one week and 89.6% of routine cases were seen within four weeks. Those figures can be improved but I think that they are impressive. They show that progress is being made and that we are taking this issue seriously.

Medicines and Medical Devices Bill

Debate between Lord Bethell and Baroness Thornton
Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, what a helpful and instructive debate, and I thank all noble Lords who were involved.

In December 2020, we witnessed a landmark moment in our battle against Covid: the launch of an effective and safe vaccination programme, which has yielded great results. Thankfully, confidence in vaccines remains very high across the UK. None the less, some citizens have questions and there is a prevalence of misinformation. It is therefore absolutely and entirely right that we should answer those questions in the spirit of constructive dialogue, which is exactly what we seek to do.

I completely share the aspiration of the noble Baroness, Lady Bennett, for Covid to be an inflection point in a business model moving away from late-stage acute medicine toward prevention. Vaccines play an absolutely critical role in that, and this could be a profound legacy of this awful disease.

Despite all this, I completely recognise that we have also seen a range of baseless and sometimes absurd narratives being shared, particularly through social media platforms. It is completely unacceptable that a minority of people seek to exploit legitimate questions about vaccines and spread dangerous lies about vaccines for their own malicious reasons and profit.

Noble Lords will agree that it is vital that both misinformation and disinformation about vaccines are tackled. Before I address the Government’s response on how we will handle these two challenges, I pay tribute to the cross-party alignment on this issue and the spirit in which the noble Baroness, Lady Thornton, moved her amendment. Noble Lords from all sides of the House have shown a strong commitment to tackling anti-vax conspiracies and I express profound thanks for this tremendous collective effort, of which we can all be proud.

Throughout this pandemic, we have remained committed to transparency around the vaccine and to ensuring that people have access to accurate information about the virus and vaccines. DHSC is leading extensive cross-government communications activity, providing advice and information to anyone who has questions about the vaccine.

I do not think it would be helpful for me to run through our efforts in this area in detail, but I reassure noble Lords that we have worked, and continue to work, extremely hard to rebut false information online. In March 2020, we stood up the Counter Disinformation Unit, bringing together cross-government monitoring and analysis capabilities to tackle misinformation and disinformation. The Government have worked tirelessly to act wherever false and harmful content appears on social media platforms, either by flagging the content to the platforms or through direct rebuttal on social media via our Rapid Response Unit.

We are particularly committed to dialogue with and the protection of communities that might be particularly susceptible to disinformation and which, coincidentally, are particularly vulnerable to the virus. I thank all those involved in those efforts, including ministerial colleagues and noble Lords. I note the reference by the noble Baroness, Lady Thornton, to my noble friend Lady Warsi’s optimistic update in this area.

I turn to the point the noble Baroness’s amendment makes about requiring social media platforms to remove and demonetise anti-vaccination content. My noble friend Lady Cumberlege’s points on this are extremely valid. The Government have already secured commitments from platforms such as Facebook, Twitter and Google to the principle that no company should profit from or promote anti-vaccine misinformation and disinformation, and to respond to that content much more swiftly. We are holding platforms to these commitments and have set a series of policy forums in motion, bringing together platforms, academia and civil society organisations to better develop responses to online misinformation and disinformation. These forums are chaired by my ministerial colleagues in DCMS, to whom I give thanks. I attend them and can report back that they have a constructive and thorough approach.

I understand the concern that noble Lords have about anti-vaccination content and the harm it causes. I stress that the Government are totally committed to working with the platforms and other key stakeholders to combat that content and to build public trust in our vaccination programme. I point noble Lords to the continued high rates of Covid-19 vaccine uptake that we see, which have been achieved in part by our effective approach to tackling vaccine misinformation and disinformation. We are not complacent; we are on the case. Therefore, for that reason, I hope that the noble Baroness, Lady Thornton, sees the Government’s efforts in this area and feels able to withdraw her amendment.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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I thank the Minister for that comprehensive answer. I particularly thank what I can describe only as a bouquet of Baronesses—the noble Baronesses, Lady Altmann, Lady Bennett, Lady Masham and Lady Cumberlege—for their support. I say to the noble Baroness, Lady Cumberlege, fear not: if I had intended to have a Division on this I would have given her pre-warning, do not worry. I also thank my noble friend Lord Hunt for his pertinent questions and the noble Lord, Lord Naseby, for his four action points, which were instructive and useful.

This has been a useful debate that has been worth having, because we have so few opportunities to knock around issues that we all agree on and really want to support the Government to get right. That is why I tabled the amendment. I am very happy with the response to it and I beg leave to withdraw the amendment.

Covid-19: Variant

Debate between Lord Bethell and Baroness Thornton
Wednesday 13th January 2021

(1 year, 4 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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The noble Baroness alludes to a world of analytical complexity, which is very much what we have to look forward to. The way in which this new variant has popped up and has been dramatically more transmissible presents a wholly different level of threat compared with the one that we were dealing with just six weeks ago. It is a matter of grave concern to all of us that this mutation has happened. However, I reassure noble Lords that we have very strong genomic capability in this country. Roughly 5% of all tests are analysed. It is only 5% but that is more than in most other countries, and we are putting in the analytical muscle to be able to process that data.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, we are of course facing a terrible and very serious infection, so are the Government contemplating further restrictions? If so, when will we know that there are going to be further restrictions? It seems to me that the ones we have right now are not working.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the decisions about further restrictions in this country are a cross-departmental matter and are, frankly, above my pay grade. To address the noble Baroness’s point directly, the new variant is a very serious matter. It is as though a turbocharger has been attached to the engine of a high-performance car, which is going round the racetrack faster and faster. This mutation is very similar to ones in South Africa and Brazil, and, experts assess, will happen in many places around the world. We are now dealing with a significantly different virus and we have to adapt our reaction to it accordingly.

Cannabis Oil

Debate between Lord Bethell and Baroness Thornton
Tuesday 12th January 2021

(1 year, 4 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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I thank the noble Lord for sharing that personal testimony, which is extremely touching and relevant. I share with him that there is a large amount of ministerial support for the principle of this exciting and interesting area. If there is any frustration on my behalf, it is only that somehow the industry has not matured to the point that it can sponsor the kinds of clinical trials that can take these important medicines through the necessary authorisation process that can put them on the NICE list so that they are available for more patients.

Baroness Thornton Portrait Baroness Thornton (Lab)
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It is not surprising that people are astonished that important cannabis products, which can transform the lives of those suffering from debilitating, painful conditions, are approved yet still not available—and in some cases supply has been disrupted as a by-product of Brexit. Would the Minister care to speculate as to why this has not happened? It is not just that the companies have not stepped up—why have they not done so? Would the political will that has been brought to bear on various other issues faced by this Government, such as Brexit, not be usefully brought to bear on this one?

Lord Bethell Portrait Lord Bethell (Con)
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The noble Baroness puts a very reasonable challenge to the life sciences arrangements in the UK. We are blessed with major pharmaceutical companies, and a lively and exciting biotech industry, all of which are well plugged into the regulatory authorisation process. This is a novel, exciting, patient-led and innovative area. For those reasons, it has not had the financial backing of either business or the financial institutions to put in place the very simple, straightforward requirements of clinical trials, which are there for patient safety in the first place, not for government box-ticking. We are working extremely hard to try to resolve this Catch-22 situation and I hope very much indeed that we will be able to announce news on that shortly.

Covid-19: Vaccine

Debate between Lord Bethell and Baroness Thornton
Tuesday 12th January 2021

(1 year, 4 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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The noble Baroness delivers tough news to her friends and to the Chamber, and I completely agree with her analysis. The frustrating truth is that, while the efficacy of the vaccine has been tested on hundreds of thousands in clinical trials, and we can lean on that data extremely well, the transmissibility of those who are immune is not yet clear. We have put in place trials and testing regimes to understand and get to the bottom of this point. But she is entirely right: it is possible, although not proven at the moment, that those who are themselves immune are not sterile but vectors of infection. Were they, for instance, to return to this Chamber, they would potentially infect those of us such as my noble friend Lord Parkinson, who is extremely young and does not qualify for the vaccine any time soon, and who could catch the virus off an octogenarian noble Lord in an instant.

Baroness Thornton Portrait Baroness Thornton (Lab)
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The noble Baroness, Lady Hayman, raises the most important issue, which is communication and the way that the Government may allay anxiety. Something which has been put to me is that we know the risks to human health run by the creation of antibiotic resistance and the creation of mutant and resistant bacteria as a result of misuse, including inadequate doses. Can the noble Lord assure the House that immunologists are being consulted? What is their view of this risk? Anxieties are being expressed in many different ways, so there has to be better communication about this issue.

Medicines and Medical Devices Bill

Debate between Lord Bethell and Baroness Thornton
Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, I can only join in with the congratulations that everybody has expressed in this debate today. I congratulate of course the noble Baroness, Lady Cumberlege, and support her—as we have from these Benches throughout. I also congratulate and thank the Minister, the noble Baroness, Lady Penn, and also somebody who I do not think has been mentioned but I do remember sitting giving his wisdom in the many discussions we have had, who is of course the noble Earl, Lord Howe. I think the team were very wise indeed to have him sitting with them.

I am not going to say very much because I think we are there with this. Most of the questions that needed to be asked have been asked: on speed, independence, resourcing and powers, and on the issue of “relevant person”, which several noble Lords mentioned. These are the key issues.

One issue that has not been mentioned—here I thank the PSA for its brief—is the need to ensure that there is no reduction in public protection in any other areas of government policy, and that the remit of the role should link closely with the work of the other bodies involved in patient safety.

Finally, I have to say that I agree with the noble and learned Lord, Lord Mackay of Clashfern, that there has to be a four-country element in this. As the role is intended to cover only England, there should be consideration of how the link with equivalent or complementary mechanisms will work in the other countries of the UK. Otherwise, we might find ourselves with a dissonance here, which will not be in patients’ interests.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I will save my Hollywood thank-yous for the end of the process, but profound thanks will need to be said. I want to say specific thanks to those who have spoken in the debate on these amendments. There have been a large number of very thoughtful comments. The noble Baroness, Lady Thornton, and my noble and learned friend Lord Mackay both mentioned four nations and devolution. The noble Baroness, Lady Bennett, spoke on gender, my noble friend Lord O’Shaughnessy on industry advocacy, and the noble Baroness, Lady Ritchie, on Northern Ireland. It is a very long list, and I cannot address every contribution. What I will do instead is address what I think have been the key points in the debate on these very important amendments.

Amendment 65 was tabled by my noble friend Lady Cumberlege before the Government’s own. I am extremely grateful to her and her team, who have written to me expressing their thoughts. The government amendment would not have been possible without her continued engagement and that of other noble Lords whose experience and knowledge have been essential in shaping the Government’s thinking. Although there are differences between our amendments, we are agreed on the fundamental point that we must create a patient safety commissioner in order to give the voice of patients its rightful prominence. My noble friend Lord O’Shaughnessy has made that point extremely clearly and effectively.

More broadly, I hope that the amendment in my name assures my noble friend Lady Cumberlege and the House of the seriousness with which the Government takes the report First Do No Harm. The Government will continue to review this report. We made a Written Ministerial Statement on the report and its recommendations yesterday, and will respond to the whole report shortly.

A patient safety commissioner, as proposed in Amendment 65, would promote the interests of patients and other members of the public in relation to the safety of medicines and medical devices. The Government entirely agree that listening to patients is essential to preventing the sorts of issues highlighted in the report. On this, our visions for the patient safety commissioner are as one.

However, Amendment 65 in the name of my noble friend Lady Cumberlege differs in specific ways. Her proposed new subsection (2) provides that the Cabinet Office would host and fund the patient safety commissioner. My noble friend has argued here and in Committee—and, indeed, in her report—that this would be necessary to safeguard the independence of the commissioner. I simply do not agree. It is common practice for commissioners to be sponsored by the government department with relevant policy responsibility, and it is entirely unclear to me what the benefit of sponsorship elsewhere would be. The process of public appointments is set out clearly; there is no question of undue influence by the sponsoring Secretary of State. The process is there—in fact, it is public. Nor does the identity of the sponsoring department amend or change the powers and functions of the commissioner; it is simply how the body is supported.

There are also differences in the way in which my noble friend’s intention is executed. In her report, she was clear that working with other bodies was necessary and, as I would hope, obvious as part of any commissioner’s remit. However, Amendment 65 is unclear as to how the commissioner would interact with other regulatory bodies. For example, proposed new subsection (5)(e) would allow the commissioner to receive direct reports from patients and any other persons, including regulators and the public. However, the CQC, the Parliamentary and Health Service Ombudsman and the MHRA, among others, are all open to receiving direct reports from patients and the public. They have a responsibility to listen to complainants. These bodies also have their own routes for reporting. For example, as we know from the vaccines rollout, adverse incidents relating to medicines and medical devices are reported through the MHRA’s yellow card scheme.

Without differentiation between taking receipt of direct reports to further a broader investigation and acting as an ombudsman, Amendment 65 might create a body overwhelmed by patient reporting and investigating individual cases. The noble Lords, Lord Patel and Lord Hunt, both referred to past agencies here, but where the best route to resolution sits elsewhere. The report itself said that the commissioner should not investigate individual cases, yet this boundary is absent from the amendment.

Proposed new subsection (7) enables the commissioner to require information from public bodies and others for the purposes of producing and laying before Parliament reports regarding patient safety, but “other” would extend to private individuals—a very expansive group indeed. The amendment tabled by my noble friend provides for the commissioner to make reports only to the Secretary of State and Parliament, and not to a range of bodies as in the government amendment. Nor does my noble friend’s amendment provide for what would happen if these individuals did not respond.

“Relevant person” is a broad definition. I am confident that it will enable the commissioner to engage with the organisations necessary to fulfil their functions effectively. In addition, proposed new paragraph 3(1)(b) of Schedule A1 would enable the commissioner to receive information from and consult

“any other person the Commissioner thinks appropriate”.

This provides the commissioner with all the relevant tools necessary. A vital difference between my amendment and the proposals of my noble friend is that, in mine, provisions are made for the patient safety commissioner to make reports and recommendations to relevant public authorities or persons, and for that authority or person to have a duty to respond to these; I think that is vital.

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I thank noble Lords for an extremely powerful session on these amendments. I confess that I completely share the aspiration voiced by many noble Lords about Britain having the best possible legislation on life sciences in the world. As the Life Sciences Minister, that is a natural ambition, but it is also a real possibility, and it is what we are working towards at the department, and through the Bill. But I have severe reservations about whether this approach is the right mechanism, and I would like to address those directly.

The noble Baroness, Lady Thornton, has tabled Amendment 2, which relates to the sunset clause, and with this amendment it would be convenient to speak to Amendments 26, 27, 39, 40 and 63. I will come to Amendment 2 shortly but, first, I cannot say that Amendment 26 is a big surprise. The noble Lord, Lord Patel, who authored it, indicated as much when he and other noble Lords discussed these matters after the excellent debate in Grand Committee. The intent of his amendment is to require the Government to publish draft legislation within three years—legislation that consolidates medicines and medical devices regulation. I understand the arguments made during Committee, and again here today, that the regulation could benefit from clarification and those arguments made on how secondary legislation could be used. The amendments in the name of the noble Baroness, Lady Thornton, go further. They would append a sunset clause after three years—I repeat, three years—requiring not draft legislation but passed legislation.

I start by addressing the timing put forward. The noble Lord, Lord Patel, asks for the Government to publish draft legislation within three years of Royal Assent. I assume that he intends this consolidation effort to include changes made under the delegated powers in the Bill, including policy that may be made to, for example, take forward a national falsified medicines scheme. The noble Baroness’s amendment would have the delegated powers lapse entirely, leaving us without the ability to amend or supplement the regulatory regimes at that point. In reality, three years between Royal Assent and draft legislation ready for publication that consolidates the existing legislation and includes any changes made under the Bill is just not long enough. Each change to the regulatory regimes will take time. Public consultation must be conducted and amending regulations must be laid, debated and so on. We do not intend—in fact, it would not be possible—to front-load policy changes into the first half of 2021, let alone 2021 at all.

Noble Lords have spoken to the importance of consultation. I say it would not just be the Government front-loading legislation; it would be about asking the affected sectors to engage with a lot of consultation very quickly and in parallel. That does not seem the right way to go about it at all. It inevitably means that the sorts of exciting policy changes that support our life sciences sector and protect patients will take an enormous amount of time to stand up. Developing and consulting on policy proposals that require legislative changes takes time, as does the drafting of any proposed legislation. Before getting to the point of drafting the legislation and so on, you need to have made an assessment of what it would be appropriate to consolidate —and that takes time.

The Human Medicines Regulations 2012 were the product of a consolidation exercise that required extensive consultation. Consultations were run while explanatory documents setting out changes so far, and so on, were all prepared before the regulations were made. Let me be clear on the timescale involved in that exercise. A concept paper was issued by the MHRA in 2009. There was an expectation that consolidating human medicines regulations, including looking at the Medicines Act 1968, would take around three years to complete. That concept paper was put out to consultation; a response was published and further consultation took place in 2010.

The first complete draft of the regulations was published in August 2010 and a number of specific consultations also run in that year. A further consultation, following the consultation on the draft regulations of August, was run between October 2011 and January 2012. Three years is the time it takes to do the comprehensive exercise that the noble Lord, Lord Patel, alludes to in his amendment, and that exercise did not involve making up new primary legislation in the first place: it resulted in the Human Medicines Regulations 2012. The noble Lord has extended his amendments to medical devices and veterinary medicines as well.

The noble Lord cannot mean us to start a review the day after this Act is given Royal Assent, with the intention of bringing forward proposals within three years. There would be no legislation made under the Act to assess. I cannot see an exercise of seeing what to consolidate and then preparing the drafting taking less than a year altogether. In fact, it would more likely take much longer if the consolidation is intended to be as far-reaching as the noble Lord and others have very powerfully indicated. Taken together, the noble Lord’s amendments would mean that the process would need to start by 2022, but not all the legislative change to be brought forward under the Bill’s powers would yet be made and in effect.

I anticipate that a consolidation exercise as proposed by the noble Lord would wish to consider the practical effects and operation of such a complex and comprehensive body of legislation. In order to do that, we would need time for the secondary legislation to be made to deliver policy. Industry then has to comply with revised regulatory changes and the MHRA needs to assess how it works. This does not, as the noble Lord may recognise, amount to a realistic exercise. We will not have all the pieces to assess before he asks us to conduct the assessment and also provide an alternative. Change takes time. The standstill period for medical devices, for example, lasts two and a half years, in recognition of this, so while some changes are likely to be made to the regulatory regimes within three years, some will not. When his proposal amounts to no more than a year of operable amending legislation to assess and consolidate—perhaps less—it is therefore impracticable.

This issue is compounded by the noble Baroness’s Amendments 2, 27 and 40, which would introduce a sunset clause to the regulation-making powers in Parts 1, 2 and 3 of the Bill, in effect creating a new cliff edge at the end of three years, after which the existing regulatory regimes cannot be updated. If what the noble Baroness seeks is similar to what the noble Lord, Lord Patel, seeks—an assessment of whether secondary legislation is the right place for the regulatory regimes—I say to her that the means simply do not fit the ends. Introducing a cliff edge in legislation is unhelpful. It forces legislation on to the timescale of a sunset clause. It does not allow for pandemics or for the consideration of new developments that arise and need to be addressed.

The noble Baroness’s amendments would further compress the timescale, stripping out another year. Working back from a sunset clause of three years’ time, we would need Royal Assent of a new Act by then. Let us be generous and provide for a year of parliamentary scrutiny. We began this Bill in February last year; it is January now and we must allow parliamentary drafters to do their job of translating policy intent into clauses. The noble Baroness and the noble Lord have both argued in favour of a very different drafting approach: let us give them, say, a year. While that may seem a long time, I suggest that many noble Lords have experienced the challenges of drafting amendments. There are questions about intent and about the choice of language, and these would apply to tens and possibly hundreds of clauses. Suddenly, that time is not very long at all. That then leaves us with a year from Royal Assent to begin the drafting process—not even the assessment process. All the problems I have already mentioned, including the inability to set up a regime to assess and not only pass legislation but implement that legislation, apply, but much more urgently.

We must also consider the impact on those who are being regulated. The arguments I advanced in Committee on the uncertainty that this would create for businesses, manufacturers and, importantly, patients apply very gravely but would become even more critical. In effect, we would be making regulation in 2021—potentially substantive, bold new regulation to protect patients from harm and ensure the highest standards of safety for medical devices—but we would also be saying that this would be immediately under review, and potentially completely rewritten within three years. The new policy to be delivered by these regulatory changes would not be able to come into force, be implemented and enforced before we would be back here again. I simply cannot think that this is good regulation.

I am sympathetic to the issue of how Parliament assesses our plans. There are, of course, avenues open to Parliament to consider whether it wishes to express a view to the Government on any particular topic. We have Select Committees to scrutinise government policy and we have provided for a reporting requirement in the Bill that gives Parliament the opportunity to reflect on the legislation we have made under the Bill in the first two years and any plans we have at that point to make further changes in response to concerns and proposals raised in relation to it. There are institutions such as the Law Commission that can be called upon to take a view on whether legislation is the right legislation, or too complex. However, if noble Lords want me to say, “In three years, we will have made changes under this Bill that are right to consolidate, and we will be in a position then to review and assess and produce something for Parliament to look at,” I simply cannot give them that assurance; nor can I say anything similar to the noble Baroness.

We need to make changes to the regulatory regimes and follow the full and thorough processes to do so, including public consultation and, most likely, draft affirmative amending regulations. We need to have them working, understood and operable by industry and the regulators. Getting that up and running is where I think we need to direct our resources, before we can think about reviews of how it works. To that end, I hope the noble Baroness understands why I am not able to concede here. I hope she feels able to withdraw her amendment and that the noble Lord will not feel compelled to press his.

Baroness Thornton Portrait Baroness Thornton (Lab)
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I thank the Minister for that. The words, “Yes, Minister” came to mind. It was a very long, wordy way of saying no, but I suppose he had to say it. I thank the noble Lords, Lord Patel and Lord Kakkar, the noble and learned Lord, Lord Mackay, and the noble Baroness, Lady Jolly, for their support and their speeches, as well as my noble friend Lord Hunt and other noble Lords. I particularly agreed with the noble Lord, Lord Naseby. Although we may disagree about sunset clauses, he absolutely hit the nail on the head about the need for consolidation. We link these together because we think there needs to be a time limit.

The Minister said absolutely nothing about what he thinks may happen next. It is simply not acceptable, and the House of Lords scrutiny committees—the Constitution Committee and the Delegated Powers Committee—said that it is not acceptable, democratic, accountable or even safe to continue to run this area of public policy simply by regulation. Since the Minister and the Government have not brought forward anything that actually tackles that problem, that is what this suite of amendments seeks to do. All the discussion we have had in the past hour tells me that we are right to do this.

I say to the noble Lord, Lord Lansley, who mentioned the Law Commission during our discussions about this, that that is a bit of a phantom. We all know that the Law Commission works on a three- to four-year cycle. It is a law unto itself: the Government cannot instruct the Law Commission to do anything, quite rightly. That may or may not be the right way forward, but it could take 10 or 15 years: it certainly does not hurry itself. So, in theory it is quite a nice idea, but I suspect that it would probably not work within the time limits we have before us.

I listened carefully to the Minister. It was a classic explanation of why something cannot be done and, on that basis, since the Minister seems to think that nothing can be done, I beg to test the opinion of the House.

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Baroness Thornton Portrait Baroness Thornton (Lab)
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The noble Baroness, Lady Jolly, and I are not in a competition about who can speak most briefly, but we have promised the Minister that we will—I overshot my promised three minutes by a minute in an earlier speech.

I say from these Benches that we will support this amendment and we are very pleased to be doing so. I reread the debate and discussion in Grand Committee, and I was actually so impressed with my remarks that I am nearly tempted to read them out again, but I will not do so. I also have to say that the whole debate was very good and important.

As my noble friend Lord Hunt says, this is not just about this Bill; this is about how the Government intend to move forward in terms of legislation and policy and subject themselves to appropriate scrutiny. That is what this amendment is about, in our view, and that is why we will support it.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am afraid I will breach the convention on short speeches, but only because this has been an incredibly powerful debate. The points were made very thoughtfully, and I am grateful for the fact that they were made briefly. I want to tackle them head on and perhaps, I hope, persuade the noble Lord, Lord Sharkey, to back off from these amendments.

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I completely concur with the noble Baroness, Lady Jolly. This has been a fascinating debate but I will restrict my comments to a few specifics in answering some of the questions raised by noble Lords. I shall start by talking briefly about risks and benefits, which I hope will provide further reassurances to noble Lords regarding their questions on these points.

A regulatory change that, for example, makes changes similar to those made to ensure the smooth vaccination programme for Covid-19, will require different assessment to those that change the medical devices regulatory regime to step up scrutiny of medical devices. The noble Lords, Lord Patel and Lord Kakkar, spent some time in Committee speaking to the importance of medical device regulation, and I agree with them. The amendments that I have tabled are silent on whether the impact on safety must be negative or positive to have the “lock” kick in. It applies to both.

However, it will come down to what the change is in order to determine what constitutes a risk in that scenario versus a benefit. That is obvious in the case of the Covid vaccine rollout. There is greater benefit to a smooth rollout of the vaccine programme than the risk of increasing the number of healthcare professionals who can deliver it. Risks can be mitigated, and they should be. Changes can also be highly technical. They may affect the safety of medicines or medical devices in a minor way but not to the same degree or extent as other changes. It would be impracticable to develop criteria that apply in all circumstances to all regulatory changes.

In response to my noble friend Lord O’Shaughnessy, I should reassure him that it is not our intention to in any way water down or reduce standards in the life sciences area. Instead, it is our intention to use this legislation to champion the UK’s wonderful life sciences sector.

We have often spoken of safety—I thank the noble Baroness, Lady Thornton, for her words on that matter—and of the vital importance of the regulator putting this at the heart of its work. Our regulator is stuffed full of scientists and experts. They are able to support the Secretary of State in making that assessment, based on the evidence. Would this change impact the highly regulated safety considerations, and are they the right ones to make? We need to empower those experts to make those recommendations, in specific circumstances. I hope that noble Lords agree with me that the Bill is better for the changes that we have already sought to make, that the questions behind these further changes are answered, and that we have reached a point of conclusion.

Baroness Thornton Portrait Baroness Thornton (Lab)
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That debate was definitely worth having, notwithstanding the fact that the noble Lord, Lord Lansley, explained the process that we had gone through when discussing what to do and how to improve the Bill regarding these aspects. They were important discussions. The noble Lord, Lord O’Shaughnessy, asked pertinent questions that the Minister has answered and are now on the record. I thank the noble Baroness, Lady Jolly, for explaining why we felt that it was important to have this discussion. I also thank other noble Lords for their remarks and the support they have given. I beg leave to withdraw my amendment.

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Baroness Thornton Portrait Baroness Thornton (Lab)
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I am grateful to the noble Lord, Lord Clement-Jones, for his full and comprehensive explanation of the background thinking behind this amendment. It is clearly important that we understand and have clarity about the scope of Clause 3, and it is that clarity we seek from the Minister this evening. As my noble friend Lord Hunt said, we are urging the Minister to respond about how Clause 3 might be used. It is not good practice when you are law-making to put something in a Bill that might just come in useful at some point. The House probably needs a wider explanation and reassurance about this clause and how it will be used.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am enormously grateful for that helpful debate. Let me try to provide some of the clarity and reassurances noble Lords have sought. Amendment 14 to Clause 3 would add constraints to the use of data collected as part of the operation of any national falsified medicines scheme. I understand that the intention of Amendment 14, in the name of the noble Lord, Lord Clement-Jones, is to prevent the use of data collected for any additional use other than for the purpose of ensuring patient safety. We discussed this at length in Committee and afterwards, and I am grateful to the noble Lord and to other noble Lords who have given up their time to discuss this important issue. I know that the noble Lord has returned to this because he thinks it is worth continued debate, so I would like to reassure him that we have thought very carefully indeed about the power in Clause 3(1)(b).

I will start with the context of the power to use information collected as part of any potential future national falsified medicines scheme. First, it is important to note that the overarching principles of the Bill set out in Clause 1 also apply to, and are constrained by, the powers in Clause 3.

Amendment 4 in my name would ensure that in making regulatory changes under Clause 3—not just around how information will be used—the appropriate authority’s overarching objective must be safeguarding public health. In making that assessment, one of the things the appropriate authority must have regard to is the safety of medicines. Further, we have provided for a clear and unambiguous lock on patient safety; that is, as part of the decision-making process behind regulatory changes, if proposed changes have an impact on the safety of human medicines, the appropriate authority may make those changes only if the benefits outweigh the risks.

Secondly, of course, any regulations providing a framework for the use of the information will be subject to parliamentary scrutiny under the draft affirmative procedure. So, the scope of Clause 3(1)(b), which is the focus of our discussion, is not unfettered. I have discussed previously the statutory requirement to consult before making regulatory changes. Powers at Clause 3(1)(a), (2) and (3) will provide us with the means to make the regulatory changes to establish a verification system, if appropriate. As part of the effective operation of any such system, information will need to be collected. It is only once we have established the need for a verification system, and how it could work, that we can fully consider how the information it collects could be used to deliver additional benefits for the UK and for patients. Clause 3(1)(b) and (3) enable us to make appropriate best use of the data collected as part of a national focused scheme and ensure that the appropriate authority must have regard to the importance of ensuring that information is retained securely.

I want to reassure noble Lords by being as clear as I can that the data in question is that which would be collected for the prevention of the supply of falsified medicines—that is, as part of the operation of any verification scheme. I reassure noble Lords that we could not expand the data being collected using Clause 3(1)(b) as part of a verification scheme. However, we want to maximise the use of data collected as part of any verification scheme where it is in the public interest. In this, we would be learning from the EU scheme, which, for example, allows data to be used beyond patient safety for reimbursement purposes and in delivering a solution that works at a national level. I reassure the Chamber by being as clear as I can be that the powers in Clause 3 do not include the collection of patient data. As with the current European scheme, there are no plans for any future national falsified medicines system to collect patient data.

My concern is that putting such a limit on the use of information at this time could constrain or limit options ahead of our engagement with stakeholders. Critically, it may not allow for the data to be used for all potential research purposes. We are not in a position at this moment, ahead of our engagement with stakeholders, to list all the potential ways in which data sources might be combined for research and wider public health purposes, which can go beyond patient safety. We want to be guided by our stakeholder engagement and not to restrict that process unnecessarily before we have had a chance to hear how this data could be used for public interest purposes.

We are also proposing a staged approach to engagement and consultation. We are committing to a clear and separate consultation and engagement: first, a consultation around the need for and details of any system concerned with the prevention of falsified medicines; and secondly, a specific consultation around other uses of the data collected under Clause 3(1)(b). As I have said, any regulatory changes that will provide a framework for the use of the information would be subject to parliamentary scrutiny under the draft affirmative procedure.

I believe that by developing these proposals through consultation and engagement, we are improving our policy-making and its subsequent implementation. I remind the House that we have no scope for changing these provisions at Third Reading, so if the noble Lord, Lord Clement-Jones, wants to press the matter, he will need to do that today, but I hope instead that he will have had enough clarity and reassurances from the Dispatch Box to be able to withdraw his amendment.

Covid-19: Restrictions

Debate between Lord Bethell and Baroness Thornton
Thursday 7th January 2021

(1 year, 4 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I do not know the precise nature or status of the care that the noble Baroness has, but it is true that care workers are massively prioritised, and those with pre-existing conditions are also prioritised. We cannot prioritise everyone at once. Those over 80 are at the top of the queue, but those who work with the vulnerable, those shielding and those with pre-existing conditions are also towards the top of the list. We are working as hard as we can to get vaccines to those people as soon as possible.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, on this second day of national lockdown, it is important to look to the future and make every effort to keep our families and fellow citizens safe. Given how close London’s hospitals are to being overwhelmed—within days—what are the short-term plans to alleviate this very urgent and serious challenge? I gather that the ExCel Nightingale hospital will be used either for in-patients or as a mass vaccination centre, or both. How soon will that happen?

Lord Bethell Portrait Lord Bethell (Con)
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The noble Baroness quite rightly pays tribute to the work of the NHS. An enormous amount has been done on the marginal expansion of ICUs. My local hospital, University College Hospital, has increased the number of beds from 19 to 52 by expanding the scope of the wards and the oxygen supply. We have put a huge amount of work into A&E units, often building out the front of the units to create more space. Those marginal differences are being extremely effective, and that is our first line of defence. The Nightingale hospitals are there as back-up and, if they are needed, we will bring them into play.

Obesity

Debate between Lord Bethell and Baroness Thornton
Tuesday 5th January 2021

(1 year, 4 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I can give my noble friend no such assurance. The decrease in sugar in soft drinks, as he knows full well, between 2015 and 2019, was 43.7%, and the increase in soft drink sales during that time was 14.9%. With six out of 10 adults and more than one in three children between the ages of 10 and 11 technically obese, clearly more needs to be done.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, I think that the noble Baroness, Lady Boycott, is quite correct, and I did appreciate the Minister’s last answer to his noble colleague. But perhaps the Government need to consider healthy food where they can actually influence this, such as in hospitals, schools and care homes, and reinstate standards for healthy foods in those places.

Lord Bethell Portrait Lord Bethell (Con)
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Yes, I entirely agree with the noble Baroness. There are parts of the Government’s estate where more could and should be done in order to promote healthy foods. I pay tribute to the work of Prue Leith, who has done a lot to champion healthy food in hospitals. Progress has been made; I visited Southampton hospital with her earlier last year and saw her bringing healthy food direct to the patients, and the use of trolleys in order to ensure that warm food is delivered and that food does not have to come out of a plastic bag. More can be done, but I reassure the noble Baroness that we are working hard at it.

ONS: UK Life Expectancy

Debate between Lord Bethell and Baroness Thornton
Thursday 17th December 2020

(1 year, 5 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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The noble Lord makes his point extremely delicately and politely, but he is entirely right. We have a commitment for five extra healthy years by 2035, and the combination of the Marmot review, the ONS figures and Covid make that seem an extremely daunting challenge indeed. I am not sure if I have the complete answer standing at the Dispatch Box right now. I would be glad to write to him and explain how we will undertake the Green Paper on prevention, the response to which will be published next year, as an opportunity to outline the kind of strategy he calls for.

Baroness Thornton Portrait Baroness Thornton (Lab)
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The Minister’s response to my noble friend Lord Davies of Brixton was an abrupt one, which kind of suggested that it was an accident that we are where we are with life expectancy and that the Government’s policies have no impact on that. My question actually follows very neatly from that of the noble Lord, Lord Patel. Do the Government intend to establish life expectancy and well-being as a strategic marker and measure for the whole nation’s well-being and welfare in all Acts? How will that feed into reforms for the NHS?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I think that healthy living and life expectancy is a strategic marker. We are naturally focused on it and, in particular, the disparities between communities, which have been alluded to by a number of noble Lords. The huge gap between life expectancy in Blackpool and west London is extremely disturbing, and something that the Government are highly focused on. These are complex issues. They involve government policy—as the noble Baroness quite rightly points out—but also personal behaviours, and it will very much form part of the NHS plan going forward and the rebooting of the NHS in a post-Covid world.

Covid-19: Vaccinations

Debate between Lord Bethell and Baroness Thornton
Thursday 17th December 2020

(1 year, 5 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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I hear the concerns of both the noble Lord and his mother very clearly but I assure him that, to date, the rollout has very much focused on the 70 hospital hubs where we are getting the protocols and practices about getting this extremely difficult vaccine into people’s arms correct before we roll out distribution to all GP services. It is not at all my expectation that every GP service in the country will have the vaccine, nor that they will necessarily be ready to deliver it this week, but that guidance has been distributed. If the noble Lord would like to send me the details, I will ensure that that GP practice is up to speed on this important matter.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, my concern is about NHS staff. They may need to deal with a third wave in the new year, they will be required to work through the Christmas period dealing with the current spike and they will be co-ordinating the vaccine—so they might be completely overstretched in January and February. Would it be a good idea to ensure that at least front-line, high-risk clinical area staff are vaccinated immediately? Does he agree that this would make sense from an operational point of view? I know from my work as a non-executive director of a London hospital that it would be a huge morale booster for the staff to whom we owe so much.

Lord Bethell Portrait Lord Bethell (Con)
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I take on board the noble Baroness’s points on the NHS. Its staff have been under huge pressure, which is likely to be sustained into the new year. I pay tribute to their hard work. The JCVI has looked extremely carefully at the prioritisation. The most important thing is to avoid pressure on ICUs and the threat of mortality. That has been done by prioritising age over role. I also pay tribute to the St John Ambulance service, which has done an amazing amount of work in gathering 40,000 inquiries for training on delivering the vaccine. By undergoing training, those people will relieve NHS staff of an enormous amount of the pressure that the noble Baroness rightly describes.

Covid-19 Vaccine Rollout

Debate between Lord Bethell and Baroness Thornton
Wednesday 9th December 2020

(1 year, 5 months ago)

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Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, I thank the Minister for the update today, and for the all-Peer Zoom this morning. Yesterday was indeed a happy day. Like many—including, it has to be said, the Secretary of State—I was very moved watching 90 year-old Margaret Keenan get her jab. However, the challenges of the next period are as acute as, if different from, those of the period we have been through. What is the timeline for the vaccine for people who are housebound or shielded and cannot attend a surgery, whether in a hospital or anywhere else? It seems that the easy distribution of the vaccine will depend on the new vaccines coming down the track: communications will be vital. So what communications will people receive, from whom? Will that be centrally controlled or will it be done locally—through primary care networks, for example?

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, the JCVI has laid out a clear prioritisation, putting great emphasis on those who are older—the over-80s—and those in social care. The vaccine will come to those who are shielded and living alone in due time. There are some practical issues with getting the current Pfizer vaccine: as the noble Baroness undoubtedly knows, it has to be kept in cold storage and comes in substantial batches, which are difficult to break up. The initial cohort consists of 6 million people—those over 80, and the health and social care workers who support them. As for future vaccines, those looking forward to being vaccinated should wait for a letter. Those letters are being organised through their doctors, who have access to a central database to ensure that the right prioritisation takes place.

HIV: Pre-exposure Prophylaxis

Debate between Lord Bethell and Baroness Thornton
Tuesday 1st December 2020

(1 year, 5 months ago)

Lords Chamber
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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the noble Lord makes a completely fair point. There is absolutely no question of there being a social stigma associated with taking PrEP or any kind of moral cloud over those wishing to take this important therapy. That is not in any way our purpose. He makes a valid point that there are good arguments for the supply of PrEP to be not just through GUM units but also through GPs and perhaps pharmacists. These are arguments that we hear and that we are looking at very closely. I hope that, at some point, I will be able to update the noble Lord on our progress on this matter.

Baroness Thornton Portrait Baroness Thornton (Lab)
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I remind the Minister, with regard to his last answer about funding, that just because you cannot solve all the world’s problems does not mean that you should not try to solve some of them. On that basis, can the Government provide an update on the rollout of PrEP in England? Is the Minister aware that there are local authorities that are still not providing the drug? When the ring-fenced funding for PrEP runs out in March 2021, will the Government commit to at least the £16 million per annum to make this happen for the future?

Lord Bethell Portrait Lord Bethell (Con)
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The noble Baroness makes a fair point. The rollout of PrEP has reached a great many local authorities but not all of them. The funding for it, at £11 million, has made a big impact but it has not covered all the ground. We are aware that this funding package runs out next year and we are in active engagement with local authorities in order to find a new mechanism going forward before July, when the funding will change. That said, our commitment, as I said earlier, to the principle of PrEP and its impact on reaching our targets for transmission remains resolute. I look forward to being able to announce a resolution of this funding formula.

Covid-19: Vaccination Prioritisation

Debate between Lord Bethell and Baroness Thornton
Wednesday 25th November 2020

(1 year, 6 months ago)

Lords Chamber
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Lord Bethell Portrait Lord Bethell (Con)
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I am extremely grateful to the noble Baroness for suggesting the New York precedent. It is not one that I was aware of and I will look into it. I reassure her that we are liaising with all our international partners over the vaccine rollout to ensure that we put in the best possible practice that we can.

Baroness Thornton Portrait Baroness Thornton (Lab) [V]
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My Lords, I have read the JCVI priority list. As the Minister has indicated, some granularity is going to be vital. There is so far no mention of vulnerable BAME communities, who have borne the disproportionate burden of the pandemic. How will the Government approach those vulnerabilities in setting the priorities and their implementation?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the underlying principles of the advice of the JCVI are to reduce mortality, to improve population health by reducing serious disease and to protect the NHS and the social care system. The basic insight is that the risk of serious disease and death from Covid increases exponentially with age and increases in those with a number of underlying health conditions. Those are the basic principles of the interim advice and they will evolve over time.

Medicines and Medical Devices Bill

Debate between Lord Bethell and Baroness Thornton
Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, I will be very brief, as it must be clear to the Minister that there is unanimity across the Committee in support of setting up this safer care task force. My noble friend Lord Hunt was quite right that this is about whether the Government take this report seriously, and for me this is also an issue of accountability. Recommendation 9 of nine states:

“The Government should immediately set up a task force to implement this Review’s recommendations.”


I hope that the Minister will just say, “Yes, we’ve done it”, so that we can now be told what the timeline for the task force will be and who will be involved. That is my hope from the Minister’s remarks, but if that is not to be the case, I hope that it might be the case in two or three weeks’ time when we move to the next stage of the Bill.

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, again, I thank my noble friend and her team for their work to produce the report and to ensure that patients and their families have been heard. Above all, I pay tribute to all the patients and their families who have so bravely shared their experiences to inform this important report. The report has been impactful and has already served to firmly put patient safety at the top of the agenda for all the healthcare system, and we in the Government are committed to learning from it.

On the amendment, if I may put this delicately, we must please remember that this is not a Bill to respond to the review. The Bill provides the powers needed to be able to update the current regulatory regime for medicines, devices and clinical trials in response to the end of the transition period, although the Bill does have the best interests of patients at its heart.

If it was not for the ongoing impact of Covid-19 on the health and care system, I believe that we would be discussing little else but patient safety. But, as my noble friend Lady Cumberlege has acknowledged in this Grand Committee, Covid has had a challenging impact on all our priorities, including on her own work on the NHS maternity transformation programme —and, of course, on the publication of her report, which was scheduled for the beginning of this year but, because of Covid, happened only 16 weeks ago.

I can assure noble Lords that much activity is already under way. Officials from across the healthcare system have been working together intensely since the report’s publication. They have been meeting weekly since August to ensure that we fully understand the report’s recommendations and the best way forward.

My noble friend has rightly mentioned the importance of listening to and involving patients in the implementation process. We absolutely recognise the need for effective patient engagement to ensure that we get implementation right. The Minister of State, Nadine Dorries, will provide an update on this and other matters related to the report in December, and I shall be very happy to report likewise to this House.

These debates have been clear, and I can assure noble Lords that, as part of our consideration of the report, we will of course want to be informed by the debates on this Bill before responding in detail to this very important report. I am very sympathetic to the desire of my noble friend and others to see the Government move quickly in responding to her report, but I do not agree that this Bill is a sensible method of delivery for that response. It is a weighty report, and our response will be rightly scrutinised when the Government responds to Parliament, but an amendment in this Bill is not the right mechanism. We should not be making policy through legislation, for that rarely makes for good government policy-making.

Therefore, I hope that this is a probing amendment, seeking some reassurance, rather than a firm request. In that spirit, I welcome the opportunity to update the Grand Committee on some of the progress that we are making to date.

Recommendation 1 has been implemented. The Government have, on behalf of the health and care sector, apologised to those women, their children and their families for the time that the system took to listen and respond.

We debated my noble friend Lady Cumberlege’s amendment for a patient safety commissioner just a few days ago, so I shall not repeat all the points raised. It was an insightful discussion, and I will think on it further, as I said during the debate.

We shall shortly be debating Amendments 122 and 123, on establishing a redress agency and redress schemes, so I will not pre-empt those discussions.

On recommendation 5, I know that my noble friend is already aware of work to establish specialist centres for mesh removal, but I would like to say a little more in recognition of its importance. NHS England is working closely with providers to set up the specialist mesh removal centres and is currently working to prepare for launch next April. The service specification for mesh centres describes how all centres must come together in a clinical summit to agree how we can develop the service moving forward, to agree standards that all centres will work to and to share data and outcomes. The first summit will take place tomorrow, 20 November. I am pleased to note that clinicians from the devolved nations are invited to that session too.

On recommendation 6, the MHRA has already begun a substantial programme of work to change the culture of the agency. Key priority areas are: first, listening and responding to patients; secondly, better utilising scientific evidence to strengthen and speed up decision-making on safety; and, thirdly, becoming more open and transparent in everything that the agency does. The MHRA is strengthening its yellow card scheme to make it easier for both patients and healthcare professionals.

On recommendation 7, as my noble friend will also be aware, we have debated Clause 16 of the Bill. Significantly, its provisions will mean that, in future, we can collect surgical implants and devices data from all NHS and private provider organisations, starting with mesh-related procedures and from that agreed next steps.

On recommendation 8, the General Medical Council already has guidance covering financial and commercial arrangements and conflicts of interest, which came into effect on 22 April 2013. In addition, the GMC’s updated consent guidance came into effect on 9 November. This reaffirms that any conflicts of interest that a doctor or their organisation may have should be shared with patients where relevant. We are considering whether these arrangements should be strengthened further.

My noble friend Lord O’Shaughnessy spoke of a worrying attitude of fatalism in the system, but I should also flag the work being done by GPs, universities and the royal colleges on long Covid and the excellent work being done to protect patients. We are listening to patients, who are presenting highly complex symptoms, including mental health, renal, cardiac, respiratory and other issues. I host a weekly round table that has full engagement with representative groups. We have mobilised a whole-system response. We are linking research with guideline writing for primary care in real time. We are using data thoughtfully, and we are mobilising networks of concerned groups around the country and around the world. This reflects the priority that we have already put on the recommendations of the patient safety report.

My noble friend Lady Cumberlege and her team took two and a half years to complete their review and present their findings, and I am intensely grateful for that. It is imperative, for the sake of patients and especially those who have suffered greatly, that we give this independent report the full consideration it deserves. I look forward to updating the House following the Minister’s Statement in the other place before recess. I therefore hope that my noble friend Lady Cumberlege feels able to withdraw her amendment.

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Baroness Thornton Portrait Baroness Thornton (Lab)
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I think this has been one of those really rather good and unexpectedly deep House of Lords discussions, going back into the mists of time. Until the noble Baroness, Lady Cumberlege, mentioned the redress Act, I had completely forgotten about it—it all came flooding back.

We have two quite different amendments in this group, and my noble friend Lord Hunt said at the outset that his Amendment 122 was a probing amendment. This is about opening up the discussion, which it certainly did—a discussion that has long needed resolving. The noble Lords, Lord Lansley and Lord O’Shaughnessy, were quite right in that it is an issue of the future; this group has one probing amendment about the future—what it should look like and how you create an agency that can address the issue of those harmed by medicines and medical devices. It is a very legitimate discussion, which needs to be had.

The second amendment, in the name of the noble Baroness, Lady Cumberlege, is about the future, what happens now and what happens about the harms that were done—the avoidable harms, in the case of hormone pregnancy tests, sodium valproate and pelvic mesh. That is very important indeed, and the noble Baroness is right to say that those harms must be specifically addressed by the Government and to push that. I think that is what we would be looking for—how the Government would implement those recommendations. I see the noble Baroness, and the noble Baroness, Lady Bennett, whose comments we very much welcomed and valued, but I do not think that was the last word. I hope she will involve herself in the next stage of the Bill. In fact, I am depending on it.

The Government have to address Amendment 123 in particular, because that is urgent and needs to be done now. I look forward to hearing what the Minister has to say about that in particular.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Bennett of Manor Castle—who indicated her interest in this along with my noble friend Lady Cumberlege—for raising the important issue of redress for those harmed by medicines and medical devices.

I share the review’s concern that patient voices were not heard, and I reiterate that we are committed to ensuring that the healthcare system does better at listening, learning and acting on patient concerns. Furthermore, we recognise that patients need to be at the centre of decision-making to ensure that their perspectives are built in.

Our focus is on improving the safety of medicines and medical devices so that in future there should be less need for redress. We are determined to increase patient safety and drive additional pre-market scrutiny and post-market surveillance of medical devices. For example, the yellow card scheme plays a vital role in providing an early warning that the safety of a product may require further investigation, and the MHRA is transforming and strengthening the system to make it easier for patients and healthcare professionals in the UK to directly report adverse incidents involving all medicines and medical devices. The UK has one of the safest medicines systems in the world and we will continue to make sure that patients and the public have access to the best and most innovative medicines.

Amendment 122, in the name of the noble Lord, Lord Hunt, would require the Secretary of State to bring forward proposals to establish a redress agency within 12 months of the Royal Assent of this Bill. Committing now to such an agency would short-cut the in-depth policy consideration that the review’s recommendation of a redress agency deserves, as a number of noble Lords have reasonably recognised. I understand that my noble friend Lady Cumberlege herself undertook substantial engagement with the affected patients and other parties as part of her review. Listening and consultation is a vital part of how we take forward any policy change, and it is even more important given the significance of this issue.

A redress agency would represent a significant addition to the current landscape for all stakeholders, and we need to give them time to contribute their perspectives and think through the implications for them. In particular, there is a need to work through what the determinations and parameters of such arrangements would be and how they would interface with current legal remedies—already complex—before we could agree to take forward this proposal. This would help us explore how that would affect the patient journey through different potential approaches, the costs and their value for money. We also need to be mindful of the potential impact on industry.

With regard to Amendment 123, tabled by my noble friend Lady Cumberlege, given that legal action is pending over hormone pregnancy tests, and as is usual when matters are sub judice, I am restricted in what I can say on this aspect of the amendment.

I know that the establishment of a specific redress scheme was my noble friend’s fourth recommendation in the report of the Independent Medicines and Medical Devices Safety Review. While I am very sympathetic to the desire of my noble friend and others to see the Government respond to her report and take forward her recommendations, I do not agree that policy should be made and deadlines set through primary legislation. Indeed, her report itself was sadly delayed during the current situation we find ourselves in.

I reassure the noble Lord, Lord Hunt, that we will respond to the issues raised in the amendment as part of our formal response to the Independent Medicines and Medical Devices Safety Review. The Government are considering all recommendations made in that review and will provide an update before the Christmas Recess. I hope that the noble Lord, Lord Hunt, has heard enough that is reassuring and feels able to withdraw Amendment 122, and that my noble friend Lady Cumberlege is similarly reassured not to move hers.

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Baroness Thornton Portrait Baroness Thornton (Lab)
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The only question I want to ask is the question the noble Lord, Lord Sharkey, has just asked. Can the Minister give a rational explanation about why certain parts of the Bill come into force at different times? The key question on commencement is whether the commencement schedule as drafted risks holding up any of the work that needs to be done or allows the Government to move too slowly on anything.

My colleagues in the Commons drew attention to this provision as essentially a means of saying, “at some point in the future”. Can the Minister give an indication of the timeframe in which the Government expect to get these regimes consulted on, regulated for and up and running? As the Bill is drafted, the timing is left rather open-ended.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which would require the Secretary of State to act in accordance with the guidance on the use of civil sanctions—I am sorry, I am on the wrong amendment.

Amendment 145, in the name of the noble Lord, Lord Sharkey, seeks to amend the commencement clause, Clause 44, so that all provisions would come into force on the day the Bill receives Royal Assent. I am confident that the amendment is not necessary. Clause 44(1) provides that the clauses needed to make emergency amending regulations will come into force the day the Bill receives Royal Assent.

Under Clause 44(2), a significant number of clauses come into force after the customary two-month commencement period. Chapters 3 and 4 of Part 3 come into force on a day the Secretary of State appoints which is specified in regulations. This combination of commencement provisions is for a good reason. Patients, stakeholders and Parliament must know what the law is before the law is made. The two-month commencement period allows the Government to continue to engage with industry and the relevant stakeholders properly before provisions come into force.

Importantly, Clause 44 provides for the necessary powers and provisions to come into force on Royal Assent should it be necessary, within that two-month period, to make regulations urgently in order to protect the public from an imminent risk of serious harm to health.

I understand that there may be concern about Clause 44(3), which allows the Secretary of State to determine when Chapters 3 and 4 of Part 3 come into force, but I assure the noble Lord that, again, this is for a good reason. Chapter 3 of Part 3 is concerned with enforcement and included in that is the introduction of a civil sanctions regime. Civil sanctions will act as a flexible, proportionate enforcement mechanism, enhancing the MHRA’s ability to incentivise compliance. The new civil sanctions regime requires supplementary regulations to be made under paragraph 9 of Schedule 1 before it can be fully operational. It is important that the MHRA engages with industry and stakeholders on these regulations and the accompanying guidance. Indeed, the Bill requires a consultation to be carried out before they are made. If these provisions came into force on the day the Bill achieved Royal Assent, we would have no time to make the necessary regulations. Our time to consult in advance on those regulations and the guidance would be severely condensed.

It is absolutely right that we consider the views of stakeholders and the public before making the supplementary regulations and bringing the new civil sanctions regime into force. I assure noble Lords that the Government are committed to bringing the enforcement and data and disclosure chapters into force as soon as is appropriate in order to enhance the safety of the medical devices regime. I hope the noble Lord, Lord Sharkey, understands the reasoning behind the clause and feels able to withdraw his amendment.

Covid-19: Conflicts of Interest

Debate between Lord Bethell and Baroness Thornton
Wednesday 18th November 2020

(1 year, 6 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am not sure that that is what the National Audit Office has said. It has, very reasonably, alighted on the importance of transparency and the declaration of interests, values that any reasonable Minister or public servant would subscribe to. The Cabinet Office itself has played a very energetic role during the entire pandemic, providing the systems, support and people, including contract staff, to make sure those values are upheld.

Baroness Thornton Portrait Baroness Thornton (Lab)
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May I just say to the noble Lord, Lord Robathan, that we supported the Government having the emergency powers to allow them to act quickly but it is also important, even if people are giving their services for free, that they are held properly accountable.

It is rare to be able to return to a question that one feels was unanswered the day before. I asked the Minister if George Pascoe-Watson, the chair of the lobbying company Portland Communications, had signed a confidentiality agreement upon his appointment as a ministerial adviser. I would be grateful if the Minister could specifically answer that question: did George Pascoe-Watson sign a confidentiality agreement when he was appointed? Presumably, that is on the public record. Would the Minister also inform the House if he or any of his officials have had any contact, by any means of communication, with Mr Pascoe-Watson or anyone else at Portland Communications since the Sunday Times published its story online on Saturday evening?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, the very large number of advisers, both paid and unpaid, were all processed by the department and their paperwork was then handed on to the Cabinet Office for approval. George Pascoe-Watson, as others, was sent both a declaration of interest form, which he filled in and is on record, and a volunteer agreement, which has the Official Secrets Act built into it. His work was covered by that.

Department of Health and Social Care: Unpaid Advisers

Debate between Lord Bethell and Baroness Thornton
Tuesday 17th November 2020

(1 year, 6 months ago)

Lords Chamber
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Baroness Thornton Portrait Baroness Thornton
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To ask Her Majesty’s Government what recruitment policy is used by the Department of Health and Social Care in the appointment of unpaid advisers to Ministers; and whether each such appointee is required to sign a confidentiality agreement.

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, I welcome the challenge. Perhaps I may reassure the noble Baroness that all ministerial appointments were required to declare conflicts of interest and abide by well-established codes of practice, and that all procurement went through proper departmental governance. Perhaps I may also be clear that those who stepped forward to help this country at its time of need should be praised. We should all recognise the considerable contribution of those who brought skills, energy and networks when we needed them.

Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, I do not see this Question as a challenge at all. It would appear that George Pascoe-Watson, the chair of the lobbying company, Portland Communications, was until recently an adviser to the Minister and used the words,

“the decision makers have told me personally”,

with regard to the Government’s intended Covid restrictions, in an email to his clients before the proposed restrictions have been publicly announced. In some places, this kind of thing could be regarded as insider trading—profiting from private information for one’s own or a company’s gain. Does the Minister believe that the rules of confidentiality have been broken? Will he be pursuing the matter? It clearly should be investigated. What form will the investigation take? Will it be departmental, or is it a matter for the Cabinet Office or the head of the Civil Service?

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am extremely grateful to the noble Baroness for giving me the opportunity to set the record straight. It is worth sharing with the House that the emails to which she referred were sent after George Pascoe-Watson left his role as an adviser to the department. With the greatest respect to Portland and its chairman, the emails contained nothing more than the kind of speculation that one might find in any national newspaper. Therefore, at this stage, I thank those who have served as advisers to me and the department.

Medicines and Medical Devices Bill

Debate between Lord Bethell and Baroness Thornton
Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, this group concerns the need to set up information systems—registries—which will serve the purpose of tracking medical devices. I thank the Minister and the Bill team for their very enlightening and useful presentation this morning. The noble Baroness, Lady Finlay, and other noble Lords have already explained to the Committee how these registries and databases might work. The key point, which was made by the noble Baroness, is that they should be mandatory rather than permitted. Changing “may” to “must” so that the Secretary of State has to produce the information system envisaged by Clause 16 is a small but vital change. The Minister will need to explain to the Committee why, at this stage and after the experiences expressed and covered in the report of the noble Baroness, Lady Cumberlege, there should be any discretion in this matter.

The other amendments seek to ensure that patients have a direct route to report their experience to any information system established. Again, after the dismissal of so much patient experience over so many years in the cases outlined in First Do No Harm, it would seem to be the only way to guarantee that patient experience can be heard and registered.

Amendment 96 in my name is a probing amendment which seeks clarity about whether the Government intend to track all medical devices used in the UK, or just some of them. As other noble Lords have pointed out in the course of this Committee, if supermarkets have the technology and wherewithal to track the provenance of every single food product from anywhere in the world, we would need to understand why this would not be possible for medical devices.

Amendment 107 specifically addresses the issue of surgical meshes, and requires the production of a registry for patient safety. I hope that the Committee will be seeking to discuss registries and how they are linked. On Amendment 104 on the Caldicott principles, I do not see how anybody could possibly object to that.

Lord Bethell Portrait The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
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My Lords, we had an excellent debate last week on the subject of medical device information systems at Clause 16, which is critical for how we will go forward on these points. The noble Baroness, Lady Finlay, seeks in Amendment 95 to confirm that the Government will make regulations to establish the system, not that they might. We will introduce this system; the noble Baroness provides no timescale attached to the obligation she introduces. It is essential that the regulations are informed by consultation. The discretion that “may” provides allows for this consultation to be conducted. We want the regulations to be right, not rushed.

I spoke last week on Amendment 96, in the name of the noble Baroness, Lady Thornton. Devices have varying levels of risk profile; it is our intention in the first instance to use the power in Clause 16 to require all implanted devices to be recorded in information systems. Implanted devices pose the greatest risk to patients and it is right that these should be prioritised. Consultation will help us to determine which devices ought to be captured by the information system.

On Amendment 99 in the name of the noble Baroness, Lady Finlay, we recognise the importance of all the issues in Clause 16(2): that is why they were explicitly referred to. However, there may be occasions where the inclusion of provisions in regulations on all four of the issues listed here is not appropriate or necessary. For example, in future we might wish to update the types of information in Clause 16(2)(a) to include, perhaps, a new way of recording a procedure or a device. We might have no immediate need for further provision under 16(2)(b) to 16(2)(d). Without the flexibility afforded by the current drafting, we would be prevented from making proportionate regulation limited to what was necessary.

On Amendment 100 in the name of the noble Baroness, Lady Finlay, the drafting of Clause 16(2) is sufficiently broad as to say, “among other things”. Regulation is not limited to the four suggested areas for provision at subsection (2)(a) to (d).

The noble Baroness suggests mandating recording of information on any medical device implanted into the human body and the information related to any other medical device as considered necessary for patient safety. Clause 16(2)(a) is sufficient for both these matters. While they are clearly important, the addition is unnecessary.

The noble Baroness adds a requirement of patient consent for the information to be recorded in the information system. I hope that the assurances that I provided to my noble friend Lady Cumberlege last week gave her some comfort on this point. I am happy to write further on this, but the noble Baroness will know that the information systems are conditional on regulations, on which we must consult.

The noble Baroness adds in her amendment expert oversight of any information system established under Clause 16(1). I do not think this is necessary. The information system acts as a database. Where expert oversight is needed is in the assessment of patient outcomes, where information is reviewed by clinical registries operated by experts in their field.

I understand the intent behind Amendment 101. I pay tribute to the noble Baroness, Lady Masham, and my noble friend Lady McIntosh, who put it very well. The patient voice is very important in the assessment of the efficacy and safety of medical devices, but I do not wish to confuse the purpose of the information system. It is a hub; it is not a decision-making tool. There are existing routes to raise specific concerns and experience of devices.

The yellow card scheme allows patients to complete and submit reports themselves. This gives a single, clear route for patients to avoid confusion about who to tell and how, and to ensure that all necessary parties receive all data relating to patient concerns. However, data used for analysis needs to be consistent in format and terminology to ensure that comparisons can be drawn and to maximise the ability to spot common themes and issues.

Amendment 101A in the name of the noble Baroness, Lady Finlay, is unnecessary. Even though the overarching objective of the information system is medical device safety, and therefore a reserved matter, I have made it clear that I am committed to ensuring early and ongoing consultation and engagement with colleagues in Scotland, Wales and Northern Ireland as we look to develop a UK-wide system. I say for the record that it is of great importance to us all that we work together to improve the safe use of medical devices across the four nations. I strongly agree that there is a need for a centralised approach to address the existing gaps in the traceability of medical devices placed on the market. The Government have already introduced Amendment 126 to Clause 41. Therefore, it is neither necessary nor appropriate to set out the engagement or working arrangements between the four nations in regulations.

I understand that the aim of Amendment 104 in the name of my noble friend Lord Lansley is to ensure that organisations protect any information that could identify a patient, such as their name and their records. I reassure him and others who have spoken to the amendment that this information is used and shared only when it is appropriate to do so.

On the Caldicott principles and guardians, I am sure that these matters will be brought forward by others in consultation. That is the forum for addressing these points. Adherence to the Caldicott principles is expected of all NHS organisations, including—some would say most of all—NHS Digital. The Caldicott principles have been developed into the national data guardian principles that apply in England. GDPR also requires that personal information be treated in this way. All data collected by the information system will be subject to GDPR. The intention is that the medical device information system should hold patient-identifiable information. Information that is de-identified will be shared with the relevant organisations to ensure the protection of that patient. It is unlikely that there would be any requirement to share patient-identifiable information with other organisations. MDIS would be programmed to know, when provided with notices by MHRA or others, that action needed to be taken and which patients it applied to.

Parliament oversees data protection legislation. The standards are very high, and we have no intention of lowering them. I do not think, therefore, that having regard to the Caldicott principles is necessary or would add anything material to the legal constraints that would apply to this information. Of course, we have no intention of doing anything contrary to those principles through this legislation. Regulations under Clause 16 will be subject to public consultation. Under GDPR, they are also subject to the requirement to consult the Information Commissioner’s Office. We have already begun discussions with the Information Commissioner’s Office on this basis.

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Baroness Thornton Portrait Baroness Thornton (Lab)
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I am grateful to the Minister for that detailed answer, but as far as I can see, it underlined the point about the fragmentation of patient safety. He is undoubtedly right about the need to change culture. Will the Minister look at this again, because I mentioned the three inquiries in the past 20 years that I knew about very well, and every one of them said very similar things to what the Minister has said? None of them has produced the kind of support that one would want for patients or been the catalyst required here from the patient safety commissioner. Will the Minister go back and think about this again?

Lord Bethell Portrait Lord Bethell (Con)
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I take the encouragement of the noble Baroness to heart. I would be very happy to think further on it. She makes a very good point: we know about the terrible incidents of the past and the very substantial responses that they had. I share with her the frustration that these problems continue to arise. For that reason, as I said, we are looking for a really thoughtful, considered response to the review overall. As I said in my earlier remarks, the case for a patient safety commissioner is one that we are looking at. I listened to absolutely everyone who has spoken in its advocacy, but we do not regard it as a silver bullet or a single point of catalysis, which I do not think the noble Baroness was alluding to. We are looking for a broad response to the review that would ultimately take on all the different points that the noble Baroness and her review team have made.

Covid-19: Vaccine

Debate between Lord Bethell and Baroness Thornton
Wednesday 11th November 2020

(1 year, 6 months ago)

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Lord Bethell Portrait Lord Bethell (Con)
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The noble Lord is entirely right that we have to approach the prospect of a vaccine in a measured way. There remain considerable imponderables about the effectiveness, longevity, impact and side-effects of a vaccine. These are things that we do not know yet, and we have to keep our eyes open to the limits of what the vaccine may or may not be able to do. That said, the initial data from Pfizer is incredibly encouraging. We have taken a measured approach in our communications to date. Jonathan Van-Tam, the Deputy Chief Medical Officer, is the face of the vaccine, as it were; he is the member of the Vaccine Taskforce who has brought the clinical perspective to its work, and he will remain an important voice in all this.

Baroness Thornton Portrait Baroness Thornton (Lab)
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It is good news indeed. I would like the Minister to share how the Government are preparing to build public confidence in the vaccine and counter the anti-vax campaigns. Following my noble friend’s question earlier, I would be grateful if the Minister could share with the House the plans for reaching harder-to-reach communities, so they can get the information they need and access to the vaccine when the rollout starts.

Lord Bethell Portrait Lord Bethell (Con)
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The noble Baroness is right that we face a challenge. While there will be millions of people who will come forward emphatically to have the vaccine, there will be some who are either disengaged with the British Government or actively hostile to the thought of a vaccine, and we take seriously the disruption caused by those who seek to profit either financially or politically from the confusion and distress caused by anti-vax campaigns. It is not appropriate for me to discuss at the Dispatch Box the detailed measures we are putting in place to deal with the anti-vax message, but I can reassure the noble Baroness that they are focused, energetic and proving to be effective.

We also take seriously our efforts to reach hard-to-reach communities—those who might not have confidence in the Government or we might not have the right connection with. Those communities are exactly the ones we need to vaccinate, and we are making them an enormous priority in our efforts.

Medicines and Medical Devices Bill

Debate between Lord Bethell and Baroness Thornton
Baroness Thornton Portrait Baroness Thornton (Lab)
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My Lords, I have greatly appreciated this debate, the expertise, and the explanations we have been given as to why the amendments are important. I particularly enjoyed the remarks by the noble Lord, Lord Ribeiro, about his hips: very important they are indeed.

Perhaps we should remind ourselves that Clause 16 was inserted in the Bill during the Commons stages after a cross-party effort involving the Labour Front Bench working with the Government. It provides for a data system to be set up by regulations to assist in tracking devices once they are implanted, so that safety performance and clinical effectiveness can be better monitored. The intention is that in the long term, that would support future device registries, allowing problems to be spotted earlier and patient harm to be prevented.

The amendments would tighten up that clause. The amendments tabled by the noble Baroness, Lady Finlay, are concerned with the operation of the tracker, using the devices’ unique identification. Currently, Clause 16 provides that unique device identifiers “may” be recorded as part of the data system. Quite rightly, the amendment would change that “may” to a “must”. So much of our work revolves around changing “may” to “must”.

Amendments 86 and 88 would amend Clause 13. Amendment 86 would require that UDIs should be considered as part of the packaging information on medical devices, and Amendment 88 would require that tracking devices used in individual procedures should be part of the Government’s consideration when regulating device registries. These amendments raise questions about the detail of device tracking. How will the unique identifiers be recorded and used? Those questions were raised by both the noble Baronesses, Lady Finlay and Lady Cumberlege. Will it be mandatory to record the unique device identifier in every procedure, and feed that into the data system? How can we ensure that that data is secure, and that it is recorded in the appropriate place? The Minister has those questions to answer at the end of the debate.

The noble Baroness, Lady Cumberlege, rightly addressed the issue of patient consent. She also underlined the fact that there is an opportunity in the Bill to get the law and the framework right. Amendment 103 would add to Clause 16 a requirement that the regulations must specify what information held by a data system is subject to a patient’s consent. The intention is that data held under the system should be used and shared to identify trends and trigger regulatory and clinical action where it is needed.

In her report, the noble Baroness cites the difference between a database and a registry. She is right to do so. The amendments explore the importance of the registry and the database, and the importance of patient consent —and whether we return to the subject at a later stage will depend on what the Minister now has to say.

Lord Bethell Portrait Lord Bethell (Con)
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My Lords, I am enormously grateful for that really important discussion of these critical amendments and provisions. I will take a moment to run through them in some detail. Device safety is absolutely critical to patient safety, and that is why the Government amended the Bill to include Clause 16. I pay tribute to my noble friend Lady Cumberlege, whose team helped inspire that amendment, and to the noble Baroness, Lady Finlay, who has participated in discussions on this clause. We have the benefit of her insight now.

Amendment 86 in the name of the noble Baroness, Lady Finlay, would add the unique device identifier number to the provisions in Clause 13(1)(g). These provisions currently allow the Secretary of State to make regulations about package labelling, provision of information and instructions for medical devices. UDIs would be one of the matters included within regulations made in reliance on Clause 13(1)(g), as drafted. It is therefore our belief that the amendment is not necessary.

The noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro made important and fascinating remarks on Scan4Safety. I will limit my comments, which could be extensive, to the importance and value of that scheme. We are extremely supportive of the principle of fast and accurate traceability. Scan4Safety is not the only scheme of its kind, but it is a particularly good one. It is the hope that any UDI created by these regulations will empower these valuable services. We have a session on medical device information systems coming up in the diary, when I hope very much that we can discuss how that might work. If the concern of the noble Baroness is whether we intend to make provision to require manufacturers to provide a UDI, I reassure her that that would be a condition for being placed in the UK market.

Amendment 88 to Clause 13, as the noble Baroness, Lady Finlay, has indicated, is intended to support the tracking of devices used in medical procedures by recording the UDI in a register provided for in Clause 13 or within hospital episode statistics. I completely acknowledge the noble Baroness’s intent, but there is a difference between a register at Clause 13 and a database at Clause 16, or a registry. Clause 13 provides for a register or a number of registers. The register or registers we intend to create under Clause 13 will be a list of medical devices for sale on the UK market, held by the MHRA. It will not include the individual product identifier part of the UDIs and it will not contain data or monitoring information related to individual devices. The register forms part of wider market surveillance and vigilance activity. Regulations will be able to make provision requiring information to be entered into a register, such as the unique device identifier, which all manufacturers will be required to put on their devices. Amendment 88 is therefore unnecessary.

While the registers will enable some device identification to track individual devices, it is the information system, created under regulations made under Clause 16, which will ensure that devices and procedures are tracked in the event of a concern being identified, through which patients can be contacted and appropriate action taken in each case. The use of MDIS, which I will come on to, could prompt the MHRA to use the information in the register established under Clause 13 to identify the manufacturer and take action.

Amendment 102 would add information to be recorded in any information systems established under Clause 16. All the information set out in Amendment 102 can already be required under regulations made under Clause 16, but the regulations do not have to set out all those matters and can set out other descriptions of information.

A UDI may not always be available, such as for a custom-made device, so it may not always be possible for the providers to capture this. Amendment 102 would also require the recording of every procedure that related to a medical device. I have spoken before about the number of different medical devices on the market and that they vary greatly in risk profile. It would not be necessary or cost-effective to record every procedure related to a medical device, but they could be recorded in one of the registers provided for by regulations under Clause 12, as being on the UK market.

Amendment 103 in the name of my noble friend Lady Cumberlege deals with the important issue of patient consent. It would introduce an obligation that regulations made under Clause 16 would require the Secretary of State to set out the categories or types of information that are subject to patient consent that are held by the Health and Social Care Information Centre, otherwise known as NHS Digital, or by other persons.

My noble friend has raised this with me and with officials, and she is a tireless champion of patients. I am moved and affected by the accounts she has heard. As the testimony in her review shows, the absence of data in the healthcare system is absolutely medieval, and it is exactly the purpose of the Bill to fix that. Before any data can be collected relying on the provisions at Clause 16, regulations must be made. Those regulations are subject to consultation, as at Clause 41. It is absolutely right that the system is informed by patient views, and that the process is one where it is easy to engage, to understand what we want to do and to build consensus that it is the right thing.

My noble friend Lady Cumberlege has views on what data should be subject to opt-out versus opt-in. Privacy is a higher-order value that we should protect. The question of patient consent is really important. The noble Baroness, Lady Finlay, campaigned on the importance of opt-out organ donation and I congratulate her on her contribution to the recent change to organ donation privacy protocols, which are widely supported by the public and will save thousands of lives. She knows as well as I do that choosing to opt into measures is not as comprehensive as choosing to opt out. It is important to have enough data to draw conclusions.

Consent will not be required to input information about the surgical procedure and the UDI of the implanted device, linked to the patient, into the information system. The medical device information system is about protecting all patients who have had similar procedures, not just a particular patient. The detail of the specific device inserted, the procedure information and, if necessary, the effect that device has caused is what will be necessary for the information system to work. If there is no adverse report made by the clinician on behalf of that patient, that data acts as a control sample. It allows for other patients’ reports, where there have also been adverse reactions, to be understood as part of a wider data picture.

In her report, my noble friend raised the recommendation that detailed data should require consent in order that the data collected is necessary and proportionate. I reassure her that all data collected for the system will be necessary and proportionate. Data held by clinicians should be shared only under those circumstances, and data shared by the information system with, for example, a clinical registry for clinical assessment of whether there is an issue, should be only that which is necessary.

The intention is, that in the event there is a reported adverse reaction with a device, the medical device information system would send a report to a clinical registry. That report, suitably anonymised and stripped of patient-identifiable information but including the device UDI, would have the detail of all procedures, not just those involving adverse reactions, to further anonymise the incident. A clinical assessment would be conducted and, if it is concluded that the device is the issue, only relevant and necessary information would be sent to the MHRA to conduct its own tests.

This is a very important paragraph and one that I will emphasise. We do not need patient-identifiable information to determine whether compliance or enforcement action needs to be taken, but device information. There are routes to identifying that there are issues with adverse reactions when a clinical registry is not present, such as manufacturers’ reports or Yellow Card reports.

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Baroness Thornton Portrait Baroness Thornton (Lab)
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Can the Minister run it by me again how this will protect patients? I heard a lot being said about physicians and their reporting. I am not sure that I understand how this will avoid the problems with valproate and all the other situations with mesh unless “must” is used rather than “may”.

Lord Bethell Portrait