(3 years, 3 months ago)
Lords ChamberMy Lords, the noble Baroness is entirely right to cite the examples of Australia and New Zealand and the challenges they have had with staff manning managed quarantine facilities. I am extremely grateful to officials from both Australia and New Zealand for the very thorough briefings we had when we set up our managed quarantine facilities. We totally took on board their profound insight on that area and that was the number one thing they told us to get right. We focused on it, we have invested in it, and that has worked well to date.
My Lords, all questions have been asked and answered.
(3 years, 4 months ago)
Lords ChamberMy Lords, I reassure the noble Lord that the issue is caused by no lack of friendship or spirit of collaboration between the two Administrations. The CAA and all the relevant authorities have a huge amount of commitment to resolving this. There are legal issues that require Acts of Parliament in Ireland and in Britain in order to resolve this; these are quite substantial legal commitments that need to be timetabled and conducted through Parliament, and that is what is holding things up. I am very grateful to all those who are trying to resolve the issue.
My Lords, all supplementary questions have now been asked, and that concludes today’s Oral Questions.
(3 years, 4 months ago)
Lords ChamberMy Lords, as I mentioned earlier, DHSE has written to local authorities explaining how we recommend some of the unring-fenced £6 billion could be spent to support both those in social care residential situations and those at home. That is the correct mechanic for guiding the spending of the money, but it is the responsibility of local authorities, not of central government, to provide the support that the noble Baroness describes.
My Lords, the time allowed for this Question has now elapsed. We now come to the fourth Oral Question.
(3 years, 6 months ago)
Lords ChamberMy Lords, I am enormously grateful for the questions from both the noble Baronesses, Lady Thornton and Lady Brinton. I start by echoing both their tributes to those involved in the rollout of the vaccine. It is a remarkable national achievement and we should all be enormously proud. My own wife was vaccinated last week, and she told me that she cried as she left the GP’s surgery—so moved was she by the experience. That is something I have heard many times before.
The noble Baroness, Lady Thornton, paid tribute to all those involved in science and research, and I absolutely agree. This has been a remarkable moment for British science. We will start celebrating British Science Week tomorrow, and I cannot think of a more apt moment to do that.
The noble Baroness, Lady Thornton, asked about the highest number of deaths. There are a number of reasons. Before I move on, I mention that today is World Obesity Day, and one of the most telling pieces of research that has come out in recent weeks is the work of PHE. We must all reflect on the nation’s health and whether obesity has played a role in Britain’s higher incidence of mortality. I look forward to reflecting on this issue more in the future.
The noble Baroness, Lady Thornton, asked directly about the decisions that the Government have made, test and trace, and the borders. Let me tackle those head on. On the decisions that the Government have made, I share with the Chamber that the road map announced by the Prime Minister has landed extremely well. It is extremely conservative. It puts school openings first, which is undoubtedly the feedback we have had from both parents and the country at large. The easing of measures for the rest of the economy and civic activity is based entirely on the data that emerges from the infection rates and will be done in a way that contains the spread of the virus.
I reassure the noble Baroness that the test and trace operation has developed remarkable capacity, and both the turnaround times for the testing and the effectiveness of the tracing have now emerged as being fantastic. The tracing of the Brazilian variant pays tribute to the effectiveness of the test and trace operation, as does Project Eagle, which has been mainly focused on the South African variant. We believe that the spread of the South African variant has been largely contained by the tracing of the Project Eagle team working closely with local authorities and infection control teams around the world. It shows what we can do with this remarkable resource.
With regard to borders, the “red list” and managed quarantine system has been stood up in an extremely effective way. The families in south Gloucestershire and Aberdeen isolated themselves, as they should have done, and the handling of their variant of concern has been professional. I am led to believe that progress is being made on tracking down our Brazilian friend, the one stray person with the disease.
In answer to the question of how someone could have a test without filling in the form, we believe that there are two ways in which that could happen. Someone could walk up to a testing site, have their test but not fill in the form properly, or they could have had the test sent to them in the post and returned it without filling in the correct form. There are lessons to be learned from both potential models, and we are communicating with those who provide tests to ensure that barcodes are put on all tests.
We have to run a risk-based analysis on cross-infection at airports and infection control within airports. We could close all airports—that could be one way of doing it—but, under the circumstances, I applaud both the airlines and the airports for putting in mitigation and hygiene measures which the CMO’s office believes will be effective.
The noble Baroness, Lady Thornton, asked about sequencing. We have stood up an enormous amount of new sequencing—30,000 samples a week is our current capacity—and we have dramatically reduced the time it takes to do sequencing. The biggest problem with that is transporting the samples around the country, and therefore we are looking at distributing sequencing capacity to the Lighthouse laboratories so that once a sample tests positive, it can be automatically taken to a plate to be sequenced at the same location. We believe that that could make a big impact.
One lesson from Project Eagle I share with the House is that door-to-door tracing is quite effective, but by far the most effective means of tracing has been intelligence-led tracing. The noble Baroness, Lady Brinton, asked about the check-in data, and this has been its power: it has allowed us to trace those who may have bumped into others in, for instance, areas of hospitality. It is not the objective of that check-in data to send out alerts to large numbers of people who may have been present in a location; it is more about empowering the forensic contact tracing necessary to track down potential connections.
The noble Baroness, Lady Thornton, asked about NHS plans. I will focus on one particular area and one of the lessons we have had from recent weeks. We have done an enormous amount to contain the spread of disease and we have seen—partly because of the lockdown, partly because of the wearing of masks, partly because of hygiene—a dramatic reduction in the amount of flu and gastroenteritis across the country. It is not an unrealistic ambition to hope that NHS resources could and should be focused on reducing contagious diseases across the piece and use the lessons from testing, hygiene and diagnostics generally to massively reduce the impact of contagious diseases. That will have huge benefits to the capacity of the NHS to combat sickness and ill health generally.
I thank the noble Baroness, Lady Brinton, for her kind remarks on the contribution of those in the back office of the NHS. I am sometimes admonished by those who say that there is simply too much white-collar, managerial wastage in the NHS. I do not accept that criticism, and the rollout of the vaccine shows the immense management muscularity at the NHS which is able to organise such a huge national programme with such efficiency and courtesy.
The noble Baroness asked about clinical trials. I celebrate the fact that the large amount of really encouraging evidence that we have had has vindicated the decision by the JCVI, the MHRA and the CMO to prioritise the first dose over the distribution of second doses and to bring in the 12-week gap. That was a wise, pragmatic and impactful decision and we thank those involved.
The noble Baroness is entirely right that the large take-up among older people will have a big impact on younger people. The most influential people in anyone’s life are the people whom they love and live with. I cannot think of a better way of marketing it to younger people than the older people whom they love and live with taking the vaccine.
I also pay tribute to Professor Paul Moss and the team at Octave who are working extremely hard on the impact of the vaccine on those with immune deficiency. As the noble Baroness alluded to, the work at the University of Birmingham is at pace. It has been going on for some months, and its impact is already being shared among professionals. I am not sure whether there is an official report planned, but I reassure her that the insight and intelligence from their work is being shared across the system.
Finally, I give enormous praise to all those currently working on our borders. The situation in other countries remains extremely concerning. Variants of concern are rising in many countries, and in Europe infection rates remain extremely high. We have put in place measures on our borders that have the capacity to protect us from these variants of concern and I am enormously grateful to all those concerned who have strengthened those positions.
My Lords, we now come to the 30 minutes allocated for Back-Bench questions. I ask that questions and answers be brief so that I can call the maximum number of speakers.
My Lords, I am not an epidemiologist who can totally nail that question, but I recognise and acknowledge completely the assumption. This disease has hit the least advantaged the hardest, but trying to understand the correlation and causation of that is extremely difficult. The evidence so far suggests that some of these causes are to do with the environment: the houses that people live in, the circumstances of their employment and their behaviour within that employment. But some of this is about comorbidities and healthy lifestyles, as well as weight, which I mentioned earlier. These are all matters of grave community concern. We have to take an interest in the public health of the whole nation and we are only as strong as the weakest part. I agree with the noble Lord’s implication: this is a wake-up call for the whole country and we have to address the health of absolutely everyone.
My Lords, the time allowed for questions on the Statement has now elapsed.
(3 years, 7 months ago)
Lords ChamberMy Lords, the image of the vaccination work in Salisbury cathedral must surely be one of the most powerful images of our times. I found it an extremely touching picture to see those seeking solace in the cathedral and also their vaccination at the same time. I give praise to all those involved. Britain has been utterly emphatic in its contribution to global vaccination. We have given £574 million to developing countries to support those vaccinations. We do that for two reasons. One is self-interest, and the other is to ensure a fair distribution of the vaccines.
My Lords, the time allowed for this Question has now elapsed. Apologies to the three speakers I was unable to call.
(3 years, 8 months ago)
Lords Chamber[Inaudible]—to be more affected by their warmth and kindness. Jan was an absolute model of warmth and kindness. Having worked in the nightclub industry, I have met, worked with and enjoyed the company of many trans people, which has always proved to be an extremely uplifting experience. I am a massive supporter of the trans movement in the round.
My Lords, the time allowed for this Question has now elapsed.
(3 years, 9 months ago)
Grand CommitteeMy 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.
My Lords, I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to conclude the debate on his amendment.
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.
My Lords, I have received no request to speak after the Minister, so I call Lord Sharkey—
My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which is designed to require that the Secretary of State must “act in accordance with” the guidance on the use of civil sanctions that he is required to publish under paragraph 13 of Schedule 1, as opposed to having regard to the guidance. Paragraph 13 requires the Secretary of State to prepare and publish guidance about the use of civil sanctions. More specifically, this guidance must cover the sanctions that may be imposed if a person commits an offence, the action the Secretary of State may take, and the circumstances in which action is likely to be taken.
I understand the intention behind Amendment 146 and recognise that it is crucial that civil sanctions are imposed in a transparent and consistent manner to ensure that the regime operates effectively. However, the current drafting of Schedule 1, including the obligation on the Secretary of State to publish and have regard to guidance on the civil sanctions regime, will ensure this transparency and consistency.
The guidance will be prepared after consultation with the devolved Administrations and others. The purpose of any guidance is to provide clarity to the civil sanctions regime and detail the circumstances in which different civil sanctions may be pursued. However, instances of non-compliance or criminal activity, where the medical device regulations are concerned, need to be dealt with on a case-by-case basis. The scale, complexity and severity of non-compliance can vary significantly. As such, any resultant enforcement activity needs to be proportionate, effective and commensurate with the non-compliance or criminal activity.
The amendment in the name of the noble Baroness, Lady Thornton, would bind the Secretary of State, acting through the MRHA, to act in accordance with guidance in every instance. This would limit the regulator’s ability to arrive at and undertake the most appropriate course of enforcement action commensurate to the multifaceted nature of the case at hand. The MHRA cannot set out every circumstance where it may be appropriate to impose civil sanctions. However, by preparing, consulting and publishing a clear set of guidance we can be clear on the framework and illustrate circumstances on how and why a civil sanction might be imposed without being exhaustive.
The regulator needs civil sanction guidance that is flexible enough to appropriately address all forms of non-compliance. To mandate following the guidance to the letter could potentially mean that no action can be taken if the MHRA encounters a new example of non-compliance that has not been explicitly catered for in the guidance but clearly warrants a civil sanction. Under such circumstances, the Secretary of State will, of course, comply with obligation to publish revised guidance as required in paragraph 13 of Schedule 1.
I remind noble Lords that recipients of civil sanctions can contest the imposition of a civil sanction before it takes effect by appealing to the First-tier Tribunal. It is also worth highlighting that, as currently provided, the guidance will be statutory guidance and the regulator must have regard to it when carrying out enforcement activity.
Furthermore, this type of provision is standard across the statute book. For instance, provisions requiring regulators and statutory bodies to “have regard” to statutory guidance can be found in a wide range of legislation, from Section 2 of the Higher Education and Research Act 2017 to Section 5 of the Business and Planning Act 2020. In a civil sanctions context, Section 63 of the Regulatory Enforcement and Sanctions Act 2008 provides that provisions conferring a power on a regulator to impose a civil sanction must also make provision relating to guidance—in particular, that the regulator “must publish guidance” about its use of a sanction and
“have regard to the guidance … in exercising its functions.”
The Ecodesign for Energy-Related Products Regulations 2010 has a similar civil sanctions regime. These regulations are concerned with the establishment of a framework for the setting of ecodesign requirements for energy-related products. In paragraph 28 of Schedule 5 to those regulations the market surveillance authority
“must have regard to guidance”
while exercising his or her functions with regard to the imposition of civil sanctions. I hope that the reassurance we seek is not unusual but in line with how civil sanction and, indeed, other regimes operate domestically. For that reason, I therefore ask the noble Baroness to withdraw Amendment 146.
My Lords, I think that I have received no requests to speak after the Minister so, hoping that I have not overlooked the noble Lord, Lord Lansley, once again, I call the noble Baroness, Lady Thornton, to conclude this debate.
(3 years, 10 months ago)
Lords ChamberMy Lords, the noble Lord, Lord Scriven, put the sense of jeopardy and anxiety about the current situation extremely well. Anyone providing for their family or running a business will feel a huge amount of anxiety or even deep concern about the prospects for the next few months, and that is completely understandable. That is why we take all these matters incredibly seriously, why we are focused on it as a Government, and why we have made it such a large priority. The noble Baroness, Lady Thornton, put the grave sense of jeopardy extremely well when she referenced the Vallance graph, which was so derided when it was first posted and which has come to haunt us since then, the clear sense of concern from Jonathan Van-Tam, and the description of the state of our hospitals and intensive care units from Steve Powis. All those were grave warnings and have come to play out in a way that I am afraid worries us all.
At the heart of this debate is a question about the local lockdowns. They are necessary for those very reasons I just described. The infection rates have gone through the roof, they are profound, and they are having an impact right through all the demographics. In many cases they may have started in universities and with young people but they have moved relentlessly through the age demographics and are leading to hospitals filling up in a way that any mathematician, or anyone like me with an O-level in maths, can see is completely unsustainable without a major intervention. Our priority is to try to manage those interventions in a way that strikes the right balance, preserving the economy, keeping the schools open and keeping our lives as normal as possible, but which has an impact on the transmission of the disease. That is why these local lockdowns are so very important, because they are a way of introducing targeted measures to populations in a way that can close down the spread of the disease within a community.
When we say “community”, one of the lessons we have learned is that people travel within their regions a great deal, so we cannot be laser-like and targeted and just shut down a street, a town or a village. We have learned that we have to apply it to substantial regions; otherwise, the disease rolls from one small community to the next. Making these local lockdowns work is not in any particular government interest but in all of our interests. I ask noble Lords to step back from the temptation to introduce party politics into a subject which is driven by genuine public health concerns. It does not help anyone to talk in terms of north-south divides, people being at each other’s throats, scum, or any of the other political rhetoric that has been associated with the last week.
I come back to something that I have said many times at this Dispatch Box. It has been derided by those on the Benches opposite but it remains true and I see it every day of the week. There is a huge amount of bilateral and multilateral dialogue between central government and the agencies of central government—including the Cabinet Office, the DHSC, BEIS, MHCLG, NHS Test and Trace, and the NHS—and those in the regions and in the DAs. There are massive weekly calls, such as the one between the CMO and the DPHs, the one between the BEIS Secretary of State and the business community up and down the country, and the Thursday call between the MHCLG and 350 council chief executives and leaders. There is a relentless drumbeat of engagement and a huge amount of engagement on a one-to-one basis, as was shown by the revealing telephone logs of those on the phone to the mayor of Manchester on Wednesday, which seems to suggest that he was much more in touch with central government than perhaps was apparent from his photo call. I reassure the Chamber that that spirit of partnership to get the local national partnership working is genuine, backed by substantial amounts of money—£1 billion has been pledged for local authorities to support the local lockdown policy—and it is in all our interests to get this to work.
If it does not work, and if there is not the political leadership and trust at a community basis in the efficacy of this approach, we have only one choice. I am looking at the SAGE table which I have in front of me, and it is really clear. These kinds of tactical interventions can knock a point or two off R. However, the only way of knocking an integer off R is a national, home-based lockdown. That is the alternative: that we all go back to March and April, to being at home, with shops closed and no travel. If this local lockdown policy does not work, that is where we will end up, and that is why we are committed to working as hard as we can.
I pay tribute to the large number of those involved in local government at all levels who have worked really hard in their communities to make it work. We are here to talk about Lancashire, and I pay tribute to those in Lancashire who have agreed to and in fact called for the lockdown there. The noble Baroness, Lady Thornton, and the noble Lord, Lord Scriven, are right on the exit strategy. It is absolutely critical that everyone understands what the exit strategy is, and our focus needs to be on that. But I can tell your Lordships that it takes a lot longer to get out than it does to get in. The ramp up is a lot steeper than the ramp down, and it is a big struggle that will need the support of individuals, households, streets, communities, local authorities, regions, mayors and the national resources to make it work. I very much appeal for collaboration in this matter and hope that we can move on from what the noble Baroness, Lady Thornton, rightly characterised as a bit of an unseemly scramble this week.
The noble Baroness, Lady Thornton asked about shielding, which is incredibly important. We wrote to the shielding list on 13 October. That letter struck the balance between the need to protect those who are vulnerable and to take on board the feedback from many, including those in the Chamber today, that extreme shielding—locking up those who are vulnerable —does not support their mental health and will have massive consequences for them personally and for their communities. Therefore, the advice we have provided, in consultation with charities and groups representing those who are being shielded, strikes the right balance.
The noble Lord said something that I need to knock on the head in a big way, because it is a very destructive and counterproductive idea. He said that the fact that we are bringing in local lockdowns is itself proof of the failure of test and trace. That is simply not true. The only way to beat the virus is through the principal interaction of “hands, face, space”. You cannot break the virus’s spread entirely by isolating those who, retrospectively, you have identified as having the disease. That will never work, and we have never claimed it will work. SAGE and the Royal Society have been very clear that the impact of test and trace is complementary but it is not unique. The idea that local lockdowns are somehow solely and uniquely caused by the failure of test and trace takes the responsibility for beating the virus away from individuals, communities, employers, local authorities and the Government. With the greatest respect, I plead with the noble Lord to move away from that rhetoric, because it undermines the public communication of the importance of “hands, face, space”.
I return to my opening remarks. No one could take the development of these local lockdowns more seriously than the Government. It is done with huge regret. We can see perhaps the flattening of some numbers in some places that would indicate that local lockdowns are having an impact. It is too early to call at this stage. However, I live in hope that they will have the impact that we desire, and I live in fear that they will not.
My Lords, we now come to the 30 minutes allocated for Back-Bench questions. I ask that questions and answers be brief so that the maximum number of speakers can be called.
My Lords, it is with great regret that central government imposes lockdowns under the tiering arrangement. In all the other areas where we have put in local restrictions, it has been done either at the immediate and clear request of the local authorities or in close collaboration with them. That is our intention going forward: we do not intend to impose anything. In fact, the considerable time lag in Manchester, which, as everyone, took many days before the imposition of restrictions, was extremely regrettable, and we will reflect on the cost of that to the community in Manchester at a future date.
Both the noble Lords, Lord Robathan and Lord Desai, who are next on the list, have withdrawn, so I call the noble Baroness, Lady Barker.
Will the Minister explain to the person in Sheffield who, having registered themselves as being positive for Covid, was contacted four times a day for four days on the trot, and managed to stop it only when they got the nurse to explain that they were so ill that they were in hospital, how their statistics will be recorded by Serco? Can he explain to the people of Sheffield why the Government continue to spend so much money on a system that is so bad?
My Lords, the exit strategy question is extremely important and I am grateful to the noble Baroness for raising it. We have not published strict criteria for each exit strategy for moving from one tier to another. It is part art and part science, in any case. We look at a large number of indices, including hospitalisation, transmission and incidence rates, and so on. What the Government and local authorities can do is to figure out local Covid plans with inherent exit strategies. We will be working on those as a matter of priority.
The noble Baroness, Lady Pidding, who is next on the list, has withdrawn , so I call the noble Baroness, Lady Blackstone
(3 years, 10 months ago)
Grand CommitteeMy Lords, I thank all those involved in this first group; indeed, they are the team who, I feel, are likely to be walking with us through a great many groups of amendments. I enormously regret the fact that some noble Lords are unable to make this session, but I thank the usual channels for their efforts in the challenging process of trying to programme the hybrid House, and for finding time for this session, and for the Bill, in a packed programme.
We are starting with one of the most important groups of amendments, which address the principles behind the Bill. I believe that is the purpose of Amendment 1, in the name of the noble Baroness, Lady Thornton, and also her Amendment 140, Amendment 139, in the names of the noble Lord, Lord Sharkey, and the noble Baroness, Lady Jolly, and Amendments 50, 67, 115 and 141, in the name of the noble Lord, Lord Patel.
Although there is some variation in the specific effects of the amendments—such as which clauses they amend and which clauses come under their scope—they all look ahead towards drawing a line under the Bill, whether that be through a sunset clause or by asking the Government to return with consolidated legislation.
I emphatically believe in the Bill. I have listened to the criticisms of the Delegated Powers and Regulatory Reform Committee, and noted the comments of the noble Baroness, Lady Thornton, and the noble Lord, Lord Patel. Those points have been powerfully made in the report, on Second Reading and here today.
I know that the report may have inspired some of these amendments, because the committee considered sunsetting the Bill to be an appropriate response—but only if the Bill had remained as previously drafted. However, as your Lordships know, I have engaged extensively with noble Lords on these matters, and have tabled many amendments to address the specific concerns that we are debating today.
A sunset clause, reviewing these matters again in two or three years’ time, will not change the very good reasons why delegated powers are necessary. It would be an unhelpful precedent, which could lead to a rolling review of all legislation. My noble friend Lord Lansley, a former Leader of the House of Commons, and my predecessor, my noble friend Lord O’Shaughnessy, both made that point very powerfully.
The noble Lord, Lord Patel, is right to say that clarity is important, but that will come through consultation. As I respond to this point, and to my noble friend Lord O’Shaughnessy and to the noble Lord, Lord Sharkey, it is worth remembering that we have published six illustrative SIs—so it is not true that we have provided no examples of how the powers could be used. I want to ponder on this well-made thought, and give further thought to how we might go further. It is hard to see how sunsetting the whole Bill would bring additional clarity to the situation.
Returning to first principles, particularly patient safety, we need to react quickly and effectively to harm. Taking swift action, such as making changes to how medicines can be administered in the community—as we are doing in relation to the Covid vaccine—is absolutely necessary when the situation requires it. So sunsetting Clauses 1 and 12 would mean also sunsetting Clauses 6 and 15. We would have no emergency provision at all until that could be replaced—a regulatory cliff edge that I would find difficult to explain to patients who needed that flexibility to get the necessary treatment.
Harm can be also significant and require more fundamental regulatory change. The report of the noble Baroness, Lady Cumberlege, suggests that the system has been slow to move and respond, and that patients have not been heard. We cannot predict or pre-empt every risk of patient harm that will emerge. Patient safety cannot wait for primary legislation. When new measures have been introduced—such as databases of medical devices under Clause 16—I cannot think why we would want to go backwards. Saying that we should no longer be able to track and trace patients, nor be able to update the data types that should be recorded to protect patients, does not make sense. Using measures in the Bill such as the information system in Clause 16, we will do better for UK patients. This is not only what the Government want but what patients want. I hope that such a system will mean that the Government will know which patients have been affected by which specific device so that they can avert problems in future.
Secondly, the changes range on a scale from significant to relatively minor, for which primary legislation would be inappropriate. For instance, changing labelling to include pictograms is not a matter that needs to wait for a future Bill.
Thirdly, this is a modern and fast-changing industry, as the noble Lords, Lord Hunt and Lord Kakkar, put it so well. In two or three years’ time, we may still need to preserve our ability to amend and update regulations. We will need to provide confidence to businesses, patients and other parties that the statute book will keep pace with change. While much will be said on the attractiveness of the UK, this is a very real issue.
In response to the comments of the noble Baroness, Lady Thornton, on the benefits of a new round of consultation, perhaps even more serious is the fact that two or three years is simply not enough time for all the regulatory changes to take place—especially when we are obligated to consult all the people that noble Lords will identify when we come to that debate. Bills take time. This Bill was announced last year and was introduced in February. We are not there yet. We simply did not have enough time to judge its efficacy before we had to write it again.
On noble Lords’ amendments seeking to consolidate the legislation made in under three years, I say this: the Human Medicines Regulations were the consequence of a consolidation exercise. The Medicines Act 1968 was originally the method for regulating the way in which medicines were licensed for use in the UK. However, a number of changes were made over the years through regulations, which Parliament approved, to regulate medicines under that Act better. As such, the Human Medicines Regulations were meant to provide exactly what the noble Lord, Lord Patel, asked for: streamlined legislation that places regulatory matters in a single set of regulations.
Nor was there a lack of consultation on this approach. At the time, the MHRA took action to draw on stakeholder views and a formal consultation was run in late 2010. Parliament considered it appropriate to redirect into secondary legislation regulatory matters that required frequent changes to respond to potential safety concerns or changes in how medicines might be produced. The MHRA indicated that, should further consolidation be needed, this could be revisited. The noble Lord asked me whether there are ways of considering consolidation in the future. I must listen to him but, again, I say that three years is not a very long time at all for regulatory changes.
We recently published guidance for businesses that sets out the expected arrangements for the end of the transition period, in order to provide enough time to bring forward a standalone regulatory system and give businesses time to comply. That period of standstill will run for two and a half years; in that context, it is unlikely that, in the space of two years, there will be regulatory change that is so significant that it requires consolidation.
If your Lordships seek assurance on the visibility of how the Government will make regulations, or if your Lordships are asking me to specify our plans for how quickly we might move to the current regulations inherited from the EU, let me say this: we do not intend to make changes for the sake of it. We will do what is in the UK’s best interests. Whether our choices mean that our regulatory framework is similar to or different from regulations made by the EU does not change that approach. Regulations, rather than primary legislation, are the appropriate vehicle to protect patients best. Changes will be made subject to public consultation, and the amendment that I have tabled—on reporting obligations—will enable Parliament to consider and reflect on the Government’s use of powers in plans.
I am listening. I have proposed changes to improve the Bill—we will come to those later, having reflected on the debate—but I will face a real challenge in the new year as a result of the gap that will open up at the beginning of January if this Bill is not finished by then. I would not want to put in my place another Minister for Innovation who might also need swift regulatory change for UK patients, whether that is getting medicines approved quickly or changing who can administer them.
I hope that the noble Baroness has heard enough to reassure her and that she feels able to withdraw Amendment 1. I hope that other noble Lords with amendments in this group do not feel the need to move them.
I have received a request to speak after the Minister from the noble Lord, Lord Patel.
(3 years, 11 months ago)
Lords ChamberMy Lords, I do not have up-to-date figures for the claims up to this month, but the number is expected to have risen. We published refreshed non-statutory good practice guidance this month, for all local authorities, to ensure that public health funerals are delivered respectfully and with care, both for the individuals and their families.
My Lords, all supplementary questions have been asked.
(3 years, 11 months ago)
Lords ChamberMy Lords, the challenge faced by dentists has been profound. The challenge of contagion in a dental practice is big and challenging. But I commend dentists who have gone to huge lengths to put in PPE and hygiene arrangements so that they are able to reopen. The scale of reopenings is enormous, but there is an enormous backlog, and we will be providing support for dentists to help them meet the scale of that backlog.
My Lords, the time allowed for this Question has now elapsed.
(3 years, 11 months ago)
Lords ChamberMy Lords, I call on the noble Lord, Lord Bethell, to resume his speech.
My Lords, may I say something about local restrictions? [Connection lost.]
(4 years, 1 month ago)
Lords ChamberThe noble Baroness is entirely right that decisions on careers are often made at school and if we do not get to people then we may miss them for ever. That is why we have built a major schools component into our recent recruitment campaign. It started in April, but it has been delayed by the Covid epidemic; it will restart shortly. I have commended it a couple of times already, but I reassure the noble Baroness that it has a hefty schools component to it, which I understand is working extremely well.
My Lords, the time allowed for the Question has now elapsed.
(4 years, 1 month ago)
Lords ChamberThe noble Lord is quite right about the home production of food. During the Covid epidemic, Project Defend was put together to ensure that, as a country, we have resilient supply chains for key products, including food. The project will look at this area to assess whether interventions are necessary and will co-ordinate cross-governmental action.
My Lords, the time allowed for this Question has elapsed.
(4 years, 1 month ago)
Lords ChamberThe noble Lord is right to point out the importance of that report, which we have taken very seriously. We have worked closely with industry to find a suitable product to take into the trial process, and it is a great shame that we have not found the right combination. We are looking at how to address that cul-de-sac and I hope to unblock it shortly.
My Lords, the time allowed for the Question has elapsed and we come now to the third Oral Question.
(4 years, 2 months ago)
Lords ChamberI should be very glad to look at that request and would be grateful if the noble Baroness would forward it to me. The Young Minds movement is very important. I would say that young people, particularly girls, have been a focus of mental health issues. That has come out in the figures and it is a situation that concerns us.
My Lords, the time allowed for this Question has now elapsed.