Covid-19 Update
Lord Lexden Excerpts(3 years, 2 months ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My Lords, I am 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.
The Deputy Speaker (Lord Lexden) (Con)
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.
Lord Bethell (Con)
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.
The Deputy Speaker (Lord Lexden) (Con)
My Lords, the time allowed for questions on the Statement has now elapsed.
International Year of Health and Care Workers
Lord Lexden Excerpts(3 years, 3 months ago)
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Lord Bethell (Con)
My 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.
The Deputy Speaker (Lord Lexden) (Con)
My Lords, the time allowed for this Question has now elapsed. Apologies to the three speakers I was unable to call.
Puberty-blocker Drugs
Lord Lexden Excerpts(3 years, 4 months ago)
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Lord Bethell (Con) [V]
[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.
The Deputy Speaker (Lord Lexden) (Con)
My Lords, the time allowed for this Question has now elapsed.
Medicines and Medical Devices Bill
Lord Lexden ExcerptsThursday 19th November 2020
(3 years, 5 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-VII(Rev) Revised seventh marshalled list for Grand Committee - (17 Nov 2020)
Lord O’Shaughnessy (Con)
I shall speak to the amendments in reverse order, starting with Amendment 123 in the name of my noble friend Lady Cumberlege. As she said, these amendments deal with the here and now and with the future, and it is important that we start with the here and now. The perspective I bring to this is again informed by my work with valproate charities through the all-party group and by reflecting on the evidence compiled by charities such as INFACT and others and presented in my noble friend’s report. Historically, some 20,000 babies were exposed to valproate in the UK and half suffered harm. The disorder recognising those harms, foetal valproate spectrum disorder, was fully recognised only in 2019, although the drug was known for decades to have effects of that kind.
It must now be the case that for those families and others we put in place a proper redress scheme. They have had to battle to be recognised. They have had to battle to change clinical behaviour. They have had to battle red tape and a lack of understanding in personal impact payment schemes and in the education and health assessments carried out for young children. This is not only a historical problem; it is true today. We need a solution in the here and now. We do not need to spend huge amounts of time creating a new agency or anything else—I will come to that in a moment—but we need to address that and their harms today. I hope my noble friend will be sympathetic to that spirit.
Amendment 122 is in the name of the noble Lord, Lord Hunt. He is quite right to want to look at this structurally, given all the scandals over the years, including thalidomide, contaminated blood, which I dealt with briefly when I was a Minister, breast implants and many others. It was quite right that my noble friend Lady Cumberlege talked in her report about creating an agency and a proper redress scheme for clinical negligence. Indeed, she has been promoting such an idea since her work on maternity safety, where, as we know, are the largest financial claims and some of the most heart-breaking. I do not think any of us can deny that the system is currently broken. The noble Lord, Lord Hunt, talked about some of the data points from NHS Resolution’s annual report. The annual cost is now nearly £2.5 billion and there are total liabilities of £84 billion because of clinical negligence. A lot of that is the cost of care for people who have been harmed, but a lot of it is the frictional cost—the legal and other costs of going through the process—let alone the uncounted cost to families, especially as the average number of days to settle claims has been increasing over the past decade. There is a very strong case for acting in a big structural way to do something about this.
Having said all that, and having been responsible for this policy area as a Minister, it is a very complex situation. There is undoubtedly a case for moving to a less confrontational and swifter approach. This is not a new idea, as the noble Lord, Lord Hunt, pointed out. We have been thinking about this and legislating for this purpose for at least the past 15 years. There are good examples of no-fault compensation schemes that work in New Zealand and across Scandinavia, which generally satisfy all the participants and, importantly, change clinical behaviour, which is so important in reducing the cost. However, the truth is that this is tied up in broader tort reform, which I am definitely not expert enough to discuss, and in considerations attached to other legislation. A good example is Section 2(4) of Law Reform (Personal Injuries) Act 1948, which has been discussed in this House before and concerns the entitlements of people who have suffered from clinical negligence, but inevitably affects other people who have been harmed.
It is also true that these kinds of schemes do not necessarily save money. Indeed, the modelling I saw when I was a Minister suggested that they could end up being more expensive. That is the challenge and we have to be realistic. It might be deserved, but it is a challenge in moving from one scheme to another.
I am definitely a supporter of action on this front, and I would very much like to hear from my noble friend that work is going on. I worked closely with my noble and learned friend Lord Keen, when he was at the Ministry of Justice, on this programme, and I hope it has continued. I am not sure that this can be dealt with in the way suggested, with a clause dropped into the Bill, because of all the consequential changes and the very difficult issues that it raises, but it is unbelievably important. The cost—that liability of £80 billion—is two-thirds of annual spending on the NHS and we simply cannot go on taking on these liabilities to future tax- payers, let alone to those people who have been harmed. We need to see a more robust policy response from the Government in general on this.
The Deputy Chairman of Committees (Lord Lexden) (Con)
The next speaker on the list, the noble Baroness, Lady McIntosh of Pickering, has withdrawn, so I call the noble Lord, Lord Lansley.
Lord Lansley (Con)
My Lords, I am in the position that my noble friend Lord O’Shaughnessy was in earlier, as much of what needs to be said has been said, but I want to add a few remarks on the two amendments.
I echo what my noble friend Lord O’Shaughnessy said. In the light of the First Do No Harm report, we have to be careful to address ourselves to the issues before us and put in place schemes of redress on the three causes. I am not an expert on those, but when I was Secretary of State for Health I was only too aware, when dealing with the Thalidomide Trust or infected blood payments, for example, that when we reviewed and made payments that were more generous, we were working in what was, in effect, an administrative structure that did not necessarily have coherence or consistency. We were making what we thought were the right decisions at the time, but those who had been harmed all suffered, from their point of view, from two problems. The first was the relative lack of generosity of the payments, which were made to reflect specific needs but were not representative of the overall harm that had been done. Secondly, there was no admission of liability, which is always an issue. Liability matters. Those who are harmed want to see liability determined and accepted.
I am sympathetic to the view that not only should redress schemes be considered for the three causes in the report, but the Government should take the opportunity to think about what a redress scheme might look like more generally. My noble friend Lady Cumberlege and her colleagues looked carefully at a number or international examples. They might well have thought, with some justification, that the French scheme—I will not attempt its title in French, but it is a national office for indemnity in relation to medical accidents—is an interesting basis on which to examine the issue. We might include not only the redress schemes from previous years but the present schemes that need to be established. This is something that Ministers might want to say in relation to the continuing review into infected blood accidents.
Again, like my noble friend Lord O’Shaughnessy, I do not want to confuse what are related but distinct issues. The schemes relate to what are, in effect, systemic failures. Recommendation 3 of my noble friend Lady Cumberlege’s report appropriately says that the schemes are to provide redress in relation to avoidable harm resulting from systemic failures. There is a question, which is not entirely resolved in the report, about which test should be applied. The Government should look carefully at where liability genuinely lies. Where there is harm as a result of systemic failings, the Government have a responsibility. That is fairly straight- forward. However, that is not the same as assuming that such a scheme should encompass all the many other cases that give rise to most of the clinical negligence claims against the NHS, which result not from systemic failings but from the failings of medical practice in particular circumstances. Those are different and separate. This debate is not the right place to go on about that at length.
I was interested to hear the noble Lord, Lord Hunt of Kings Heath, talk about the NHS Redress Act 2006. The noble Baroness, Lady Thornton, will recall that in 2009 she was not able to bring that Act into force. I was the shadow Secretary of State during the passage of that Act and Secretary of State after 2010. One reason for not bringing it into force, to which my noble friend referred, was the Government’s intention to undertake tort law reform in general and this was a tort-based liability scheme.
Lord Bethell (Con)
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.
The Deputy Chairman of Committees (Lord Lexden) (Con)
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.
Lord Hunt of Kings Heath (Lab) [V]
My Lords, I think this has been an excellent debate. I fully accept, as my noble friend Lady Thornton said, that my Amendment 122 covers a much wider area than Amendment 123, which focuses on the specific issues relating to the report of the noble Baroness, Lady Cumberlege.
My Amendment 122 was definitely a probing amendment, because the current situation in relation to clinical negligence is wholly unsatisfactory. It combines the bureaucracy and slowness which the noble Baroness, Lady Bennett, referred to in relation to Windrush and she is absolutely right to draw parallels. It combines a hugely frustrating process for patients and their relatives with a system that increasingly becomes ever more expensive for the NHS. The noble Lord, Lord Bethell, was not going to be drawn on these wider considerations, but the noble Lords, Lord Lansley and Lord O’Shaughnessy, have both dealt with these—we know that it is a very complex issue, but surely, at the end of the day, we have to recognise that the current system simply is not working.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 126. I should inform the Committee that if this amendment is agreed to, I cannot call Amendments 127, 128 or 129.
Clause 41: Consultation
Amendment 126
The Deputy Chairman of Committees (Lord Lexden) (Con)
Amendments 134 to 138 have been pre-empted.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 145. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Clause 44: Commencement
Amendment 145
Lord Bethell (Con)
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.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received no request to speak after the Minister, so I call Lord Sharkey—
The Deputy Chairman of Committees (Lord Lexden) (Con)
With apologies to the noble Lord, Lord Lansley, who does wish to speak after the Minister, I now ask him to do so.
Lord Lansley (Con)
I thank the Deputy Chairman. I sent the email only about 30 seconds ago so I suppose, strictly speaking, that apologies on his part are not required. I should have anticipated the need to ask a question, but I am afraid I was prompted by listening to the noble Lord, Lord Sharkey, and the Minister’s reply. I want to ask one question: how can what will become Section 1 be brought into force without Section 2? I do not understand. If a power is to be used under Section 1, it must surely make provision about some of the long list of relevant areas in what will be Section 2. In the absence of Section 2 being in force, I cannot see how Section 1 works.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 146. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Schedule 1: Medical devices: civil sanctions
Amendment 146
Baroness Thornton (Lab)
My Lords, we have reached the final amendment so I will be as brief as I can. The first thing I need to clarify, and I do not know if other noble Lords have spotted this, is that my amendment is actually to page 32 not page 34, otherwise it makes no sense at all. It is to amend line 10 on page 32—of the Bill that I have in front of me, anyway. But maybe I have an old copy of the Bill. Paragraph 13(7) of Schedule 1 says:
“The Secretary of State must have regard to the guidance or revised guidance published under this paragraph in exercising functions under this Schedule.”
That is the point of this tightening-up amendment, which would require the Secretary of State to “act in accordance with” the guidance.
Amendment 146 is about the planned civil sanctions regime for medical devices. Part 5 of Schedule 1 provides that the Secretary of State must “prepare and publish guidance” on
“the sanctions that may be imposed on”
someone who commits an offence,
“the action that the Secretary of State may take”,
and the circumstances in which they may take such action. This could be, for example, when a penalty may or may not be imposed, the amount of such a penalty, what the Secretary of State will take into account in determining that amount and so on. Before publishing the guidance the Secretary of State will, of course, consult devolved Administrations and anyone else they consider appropriate. Where necessary, should changes be needed, the Secretary of State must revise the guidance and publish the revised version.
Once published, this guidance is the information that will be in the public domain on the operation of this regime. Yet after all that preparation, as currently drafted, the Bill says the Secretary of State must only “have regard to the guidance” when “exercising functions under this Schedule”. The amendment would simply tighten this up, so that the Secretary of State must “act in accordance with” the guidance. I look forward to the Minister’s response, and I hope we can locate it in the right place—I obviously have an old version of the Bill in front of me.
The Deputy Chairman of Committees (Lord Lexden) (Con)
The amendment proposed is to page 34, possibly corrected by the noble Baroness, Lady Thornton, to page 32.
Lord Bethell (Con)
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.
The Deputy Chairman of Committees (Lord Lexden) (Con)
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.
Baroness Thornton (Lab)
First, I need to say that I do have an old version of the Bill which I picked up from my desk on my way here, so I apologise to the Committee for that. I will read the Minister’s comments, but if the schedule already has, as I understand it, the ability to be flexible written into it—I think the Minister said that it was there in Clause 13—it seems to mean that one does not need to have regard to it. One would need to act in accordance with it, because the Bill already has built into it the flexibility needed under the circumstances that he was describing. However, I will read his comments and reflect on them. I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, that concludes the Committee’s proceedings on the Bill. I remind Members to wipe their desks and chairs before leaving the Room.
Medicines and Medical Devices Bill
Lord Lexden ExcerptsWednesday 11th November 2020
(3 years, 5 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-V Fifth marshalled list for Grand Committee - (6 Nov 2020)
Baroness Penn (Con)
My Lords, all the amendments in this group deal with the important matter of forward-thinking regulation—regulation that evolves as technology evolves. I say to the noble Baroness, Lady Thornton, that all the questions raised in this debate are very pertinent and are pro-innovation, not anti-innovation questions, concerned with ensuring that we can regulate this area properly.
As my noble friend the Minister said in previous communication to the noble Lord, Lord Freyberg, artificial intelligence is already in use in medical device technology and is already regulated—for example, Babylon’s mobile application Healthcheck is software that provides a general health assessment to users. That application is registered as class 1 medical device by the MHRA. We are also working on equipping our regulator for these products. The MHRA secured £740,000 from the Regulators’ Pioneer Fund to work with NHS Digital on developing a pilot in order to test and validate algorithms and other AI used in medical devices. There are other works in train to get the benefit of artificial intelligence in the health service. The Artificial Intelligence Award is run by the Accelerated Access Collaborative in partnership with NHSX and the National Institute for Health Research. It is making £140 million available to accelerate the testing and evaluation of the most promising AI technologies that meet the strategic aims set out in the NHS Long Term Plan.
I recognise that the intention of Amendments 83, 112 and 113 is to address the potential to cause harm to patients without appropriate regulation of these technologies. I can reassure noble Lords that software used for the application of medical devices falls within the definition of a medical device under the EU medical device directive, transposed into UK law through the Medical Devices Regulations 2002. Artificial intelligence and algorithms are encompassed within the term “software” where they have a medical purpose, and I can reassure the noble Lord, Lord Freyberg, that this covers static and dynamic algorithms.
In addition, within 12 months of this Bill gaining Royal Assent, we will start to develop new medical device regulations. The development of these regulations will include a full consultation on any changes proposed. I can commit here that the consultation will conclude within 12 months and will include the definition of a medical device, with particular reference to algorithms and methodologies used for the interpretation of data and associated technical architecture used within medical devices. This process will allow members of the public, patients and industry bodies—as well as perhaps noble Lords in this Committee—to help shape the future of regulation in the UK and the terminology that we use to describe what is captured by those regulations.
The amendments are accordingly unnecessary, as the outcome sought will be achieved under the umbrella of the wider-scale review of medical devices regulation in the UK, which will take place during a similar window as that sought by the amendment and will address the specific questions that it raises. So I hope that I have reassured the noble Lord, Lord Freyberg, that the existing definition covering both dynamic and static algorithms is sufficient and, if I have not, that he will take satisfaction from the Government’s commitment that, within 12 months, we will have concluded a consultation—to which I hope the noble Lord will contribute—that will include the definition of a medical device and specific reference to algorithms and methodologies used for interpretation of data.
This is an incredibly important debate. This is an emerging area of technology and, while we are reassured that the current regulations capture what they need to, we also need to look to the future, which is what the consultation can do. I hope that the noble Lord will feel able to withdraw his amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
I have received a request to speak after the Minister from the noble Baroness, Lady Thornton. I now call the noble Baroness.
Baroness Thornton (Lab)
I thank the noble Baroness the Minister. This is such an important issue, with the potential for huge benefits and huge harms. I regard it slightly like the sort of issues we dealt with in relation to the Human Fertilisation and Embryology Authority and the Human Tissue Authority—this is very important and runs very deep into our humanity. So the question I need to ask the Minister is: when the consultation is over, will we be looking at primary legislation, because I am not sure that regulation will quite do?
The Deputy Chairman of Committees (Lord Lexden) (Con)
We come now to the group beginning with Amendment 86. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 86
The Deputy Chairman of Committees (Lord Lexden) (Con)
I have received a request to speak after the Minister from the noble Baroness, Lady Thornton, on whom I now call.
Baroness Thornton (Lab)
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”.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 91A. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. I call the noble Baroness, Lady Finlay of Llandaff.
Baroness Finlay of Llandaff (CB) [V]
My Lords, I beg the indulgence of the Committee for just a moment because I have a horrible feeling that I have lost my place. I had thought that we were moving to Amendment 95. Perhaps the chair would be kind enough to set me right on that.
The Deputy Chairman of Committees (Lord Lexden) (Con)
I propose that we adjourn for five minutes.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, the Committee will now resume and I call again on the noble Baroness, Lady Finlay, to move her Amendment 91A.
Amendment 91A
Medicines and Medical Devices Bill
Lord Lexden ExcerptsWednesday 28th October 2020
(3 years, 6 months ago)
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The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 24. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 24
The Deputy Chairman of Committees (Lord Lexden) (Con)
The noble and learned Lord, Lord Mackay of Clashfern, has withdrawn, so I call the noble Lord, Lord Patel.
Lord Patel (CB) [V]
My Lords, it is always very difficult to follow the noble Lord, Lord Alton of Liverpool, because his speeches are always so powerful, convincing and well researched, so I do so with some hesitation. I absolutely agree with him that it is abhorrent that the plastinated bodies of human beings are used for commercial purposes in exhibitions. It is certainly not science, and I do not think it is art either. It should be banned, and I was surprised that the exhibition took place.
Tissue and organs were taken from children at the Alder Hey Hospital. I was involved in the subsequent inquiry and heard the harrowing stories of parents whose children’s organs—there were thousands of them—were taken and stored without their consent.
I was touched by and support the powerful speeches of all the preceding speakers. The noble Lord, Lord Hunt, raised an important issue and I agree that his amendment is a modest provision asking the Government to look at the issue and to amend the Human Tissue Act if necessary. In the past, I chaired for four years the Medical Research Council’s ethics committee, and for more than four years I have chaired the UK Stem Cell Bank. I am also familiar with the research ethics committee—at one time I was its chairman—of the National Patient Safety Agency, which the noble Lord, Lord Hunt of Kings Heath, chaired before me, when it introduced a nationwide regime for examining consent through that ethics committee, which is now a statutory committee. Noble Lords have rightly said that the regulation of consent in the use of tissue and organs is strict in the United Kingdom. There is strict monitoring in the use of tissues for any purpose. The noble Lord, Lord Hunt, alluded to the fact that the law on the importation of tissues is lax. If that is true, it needs to be examined. I have looked into the current law and at various websites covering human tissue importation and, in particular, the issue of consent. The noble Lord, Lord Alton of Liverpool, asked how we can be certain of the validity of the consent that was given. I agree it is an important point, and the Government should seriously consider Amendment 24.
On the issue of research, I will tell a story about HeLa cells. I do so not to immortalise HeLa cells, although they are immortal, but to immortalise the person from whom the tissue sample was taken on 8 February 1951: Henrietta Lacks—which is why they are called HeLa cells. She was a black American mother of five who developed extremely aggressive cervical cancer. She attended Johns Hopkins Hospital, in Baltimore, and a tissue for diagnostic purposes was taken from her cancer. The tissue was then passed on to a laboratory that was trying to culture cell lines. Ever since then, HeLa cells have been used all over the world to develop treatments in all kinds of therapies. For instance, Salk used them to develop the Salk polio vaccine. They were used to develop treatments for cancers, such as breast cancers. They were used for xenografts, again to develop cancer treatments. They are also being used to study aging processes. As our cells age they eventually become senescent and inflamed, which produces some of the chronic diseases that humans suffer from. That does not seem to happen with HeLa cells as regards telomerase, which controls the size of telomeres, which is part of the aging process. HeLa cells have been used for all kinds of purposes.
I have another concern about the commercialisation of tissue use. In advertisements on the internet—noble Lords can see them there if they wish—many commercial companies say: “We will supply tissues to industry for the testing of drugs”. What consent was given for the use of that tissue? Does the HTA have to give permission to import this tissue or ask where it came from? When the Government examine this issue I would only ask them to distinguish between tissues, organs and cell lines and ask why they should be treated differently. I do not say that regulation is not required; I am simply saying that, when it comes to importation, we need to have a clear understanding of why cell lines should be treated differently from tissues and organs. I support the amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
The noble Baroness, Lady Stroud, who is next on the list, has withdrawn so I call the noble Lord, Lord Sheikh.
Lord Sheikh (Con) [V]
My Lords, I fully support Amendment 24. The issue of organ harvesting was raised in the other place and at Second Reading by me and other noble Lords. The ability to use human tissue in medicines and transplants saves many lives and is a great achievement of modern science. However, we need to make sure that the way human tissue is obtained and used is completely ethical. At the moment, we do not have legislation that properly stops organs that have been obtained forcibly or without proper consent from entering the UK. That is completely unacceptable.
We should be greatly concerned about the treatment of Muslim Uighurs and Falun Gong in China. The detention and persecution of these innocent people is a crime against humanity. Millions are suffering in inhumane conditions. They are tortured and a great many have been murdered. Last year, the China Tribunal, chaired by Sir Geoffrey Nice QC, concluded that forced organ harvesting in China had been practised for a substantial time, involving a substantial number of victims. The tribunal also found that Muslim Uighurs were used as an organ bank.
The British Medical Journal found that 99% of studies that looked at organ transplants in China did not report whether the organs used were donated with consent. This is unacceptable and a disturbing violation of human rights. It is also illegal. Furthermore, The Economics of Organ Harvesting in China report found that large profits had been made from organ harvesting.
I appreciate that although the companies, including British ones, may not be directly involved with organ harvesting, they could be part of a wider system that provides devices, drugs, materials and know-how for transplantation. Sir Geoffrey Nice QC also stated that anyone interacting with the People’s Republic of China was interacting with a criminal state. If we do not have proper checks on human tissue entering the UK, we risk being complicit in this crime.
Organ harvesting is not limited to China. There are gangs and traffickers all over the world that exploit vulnerable people to obtain organs without any proper aftercare. This coercion is also illegal and must be stopped. Through this amendment we can prevent this happening and close the gaps in our existing legislation. For instance, the Human Tissue Act 2004 has strict consent and documentation requirements for tissue in the UK, but does not enforce the same standards for imported tissue. Instead, it advises only that the same standards should be applied. Although the human tissue regulations 2007 ensure that there is proper documentation and tracking from donor to recipient, they request details on how consent was obtained and look into whether the donation was voluntary or unpaid or not with consent at all. This means that there is no legislation against importing organs that have been obtained involuntarily and without consent.
We must accept this amendment so we can make better regulations that uphold human rights and values. By including the ability to make provisions about the origin and treatment of human tissue used in developing and manufacturing medicines, this amendment means that we can make regulations if there are any concerns as to whether consent has been given. This amendment would require that informed, unforced and properly documented consent must be given for all tissue entering the United Kingdom. At present we do not have appropriate safeguards against forced organ harvesting or human tissue. Innocent people are tortured and killed while businesses and some Governments have made a profit.
This amendment is an opportunity to take a proper stand against organ harvesting and to have a statutory commitment. Through this amendment we can ensure that all human tissue imports are ethical. During Second Reading, my noble friend Lord Bethell stated that the idea that any British companies profit from these trades is abhorrent. This is an abhorrent practice. We must put a stop to it and therefore we need to pass this amendment. I emphasise that it is our moral duty to do so.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received a request to speak after the Minister from the noble Baroness, Lady Northover, whom I now call.
Baroness Northover (LD) [V]
Can the Minister tell me whether she has read the China Tribunal report in preparation for this amendment, as I asked when I was speaking to it? If she has not, will she agree to do so before Report, especially to help inform her since she may come forward with her own amendment, as I hope she is indicating?
Medicines and Medical Devices Bill
Lord Lexden ExcerptsMonday 26th October 2020
(3 years, 6 months ago)
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The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, unfortunately, a connection has not been made with the noble and learned Lord, Lord Woolf, who was due to contribute remotely.
Lord O'Shaughnessy (Con) [V]
My Lords, it is a pleasure to be able to follow the noble Lords, Lord Hunt and Lord Lansley, on these amendments. The issues that they raise could not be more important. Indeed, they have both been assiduous, particularly the noble Lord, Lord Hunt, when he was opposite me at the Dispatch Box, in raising this issue of the NHS’s attitude to medical innovation. His point about the methods review is very well made. He is also right to raise the fact that the voluntary pricing scheme for medicines is designed with a cap-to-cap growth of 2%. It is hard to explain how, with the cap in place, rationing attempts are still going on within the NHS, because the cap is precisely meant to give that protection. The problem is that, with the benefits of the cap, the rebates go to the Treasury, whereas the costs of paying for medicines bite locally. Until we get that imbalance sorted out, I fear that we will have strong imperatives on local trusts and CCGs to ration as he has talked about. I regret that, as the Minister responsible for negotiating that scheme, that was not something we were able to resolve—but I hope that my noble friend will be able to next time around.
The reason why I wanted to speak in this group was to offer my strong support for the amendment proposed by my noble friend Lord Lansley, Amendment 85 on medtech funding guidance. I declare another interest here in that this was one of mine, in its current incarnation, in the industrial strategy life sciences sector deal 2 from autumn 2018. It was hard won with the NHS, for obvious reasons, but the case for doing it was very powerful, and was brought home to me by a device—a diagnostic tool by Roche Diagnostics for pre-eclampsia. It had sailed through all the medtech evaluations and had gold star guidance next to it but had only something like 5% of the uptake that we would expect, despite the fact that it saved money and lives and did everything that we would want of it. In a way, that was a powerful emblem of why we could not go on as we were and needed some sort of medtech funding guidance.
It has been two years. My noble friend Lord Lansley is quite right in tabling his amendment to, I hope, elicit a response from my noble friends at the Dispatch Box on a commitment to when a full introduction of this will be done. As we are, I hope, in that kind of positive mood, perhaps I could entice my noble friend the Minister to commit also to exploring two things: to extending the eligibility criteria for the guidance, which were very strictly drawn and quite limiting; and, as is very germane to our Covid efforts, to consider how it could be used specifically to support the diagnostic industry.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, I have received no request to speak after the Minister, so I call the noble Lord, Lord Lansley, to conclude the debate on this group.
Lord Lansley (Con)
I am most grateful to all noble Lords who participated in this debate, which I thought was very good, with a lot of points well made, including points by the noble Lord, Lord Blunkett. There were good points throughout, with hardly any that I would take issue with.
Both the noble Lord, Lord Hunt, and my noble friend Lord O’Shaughnessy will have anticipated some of the arguments that we can perhaps develop a little further when we come to Amendment 28. It may enable us to cut to the chase, as it were.
I was prompted, in listening to my noble friend and the noble Lord, to wonder what the collective noun is for former Health Ministers. I had always imagined that the appropriate collective noun for those who leave the job was a “release” of Health Ministers. I was struck, after today’s further discussions, by the thought that maybe we should be called a “frustration” of ex-Health Ministers. In every case, we know that we have become enmeshed in and, generally, absolutely fascinated by and engaged with all the issues that we get involved in in the Department of Health, but we never stay long enough to see them through in the directions that we wanted them to go or the conclusions that we wanted them to reach. Perhaps when we come to Amendment 28, I shall have a chance to talk about value-based pricing, which was something that I started but which did not happen after I left. I am thinking in this particular instance of the December 2011 report on innovation in the NHS. Many of the things that we have been talking about today were there nine years ago and continue to be there today, and we need to keep pushing forward with them.
In that context, what my noble friend the Minister said by way of reply about the consideration that the medicines regulator should give to the availability of medicines will certainly cover the ground. If, for example, the NHS makes it clear that it wants earlier access or what we might think of as breakthrough designation for medicines, that will definitely get into the “availability of medicines” consideration, so I take that point entirely. I am grateful for her explanation about the requirements laid on Ministers where they engage in consultation—that satisfies that factor.
I am particularly grateful that we have a date for the medtech funding mandate. I am glad that we are making progress. I know that that will mean that it is not subject to the vagaries of the Covid-19 crisis, which has delayed so many of the objectives that we were hoping to progress during this year and next. For NHS England, it is important. It will enable it to look after patients more effectively and potentially save costs. I am grateful to my noble friend for that. With that positive response, I beg leave to withdraw the amendment.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, we now come to the group beginning with Amendment 18. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 18
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, the noble Baroness, Lady Sheehan, has withdrawn from the debate so I call the noble Baroness, Lady Barker, who will once again speak in place of the noble Baroness, Lady Jolly.
Baroness Barker (LD)
It is a great pleasure to follow the noble Baroness, Lady Bennett of Manor Castle, who introduced these amendments in her customarily thorough and diligent way; I thank her for taking the time to do that. I also thank her for bringing to the Committee information about the sources from which she brings forward these amendments. They not just represent the aspirations of politicians who wish to pursue their own green agenda; they present the thinking on the part of clinicians and people in the health services about the impact of medicines and medical devices and what they do.
It is no bad thing to remind ourselves that, in the NHS long-term plan, there is a specific commitment to the sustainability of the NHS. It is perhaps no wonder that, when the NHS Sustainable Development Unit reports that the NHS is responsible for 25% of public sector CO2 emissions, there is a recognition that large entities such as the NHS and the British Army will be crucial if the Government are to reach our carbon reduction targets within the timetables set.
As the noble Baroness, Lady Bennett of Manor Castle, said, the NHS is an organisation that British people value very highly. It is an institution that British people do their best not to demand much of—indeed, to minimise their demands on it. It is an ongoing source of frustration for many people that it is difficult for patients to assist with recycling medicines and devices. I know that I am not alone in saying this: when I came to empty the house of my mother, who not only depended on medical devices—hearing aids—but had multiple conditions for which she took medication, I could not dispose of things such as batteries or medicines in an acceptable way. I could not take them to pharmacies and get them recycled for people who needed them. I know that many people have found themselves in that position; it is a source of great frustration for people who do not want to waste precious NHS resources and for whom being in that position is offensive.
I rather suspect, as the noble Baroness, Lady Bennett of Manor Castle, suggested, that the NHS is, at a corporate level, beginning to make some progress in looking at its use of single-use plastics, its disposal mechanisms and, in particular, its use of water. I also suspect that Covid has had a huge and damaging impact on all of that. I do not expect that we will see the NHS able to prioritise this subject for the whole of next year. That is all more the reason for us to do what the noble Baroness said we should do: make sure that this remains an aspiration towards which the NHS should work and should have an obligation to work. With that in mind, I would be very pleased to support the noble Baroness’s amendments.
The Deputy Chairman of Committees (Lord Lexden) (Con)
We now come to Amendment 19. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.
Amendment 19
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, that concludes the work of the Committee for today. The Committee stands adjourned. I remind Members to wipe their desks and chairs before leaving the Room.
Covid-19: South Yorkshire
Lord Lexden Excerpts(3 years, 6 months ago)
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The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My 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.
The Deputy Speaker (Lord Lexden) (Con)
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.
Lord Bethell (Con)
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.
The Deputy Speaker (Lord Lexden) (Con)
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.
Baroness Barker (LD)
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?
Lord Bethell (Con)
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 Deputy Speaker (Lord Lexden)(Con)
The noble Baroness, Lady Pidding, who is next on the list, has withdrawn , so I call the noble Baroness, Lady Blackstone
Medicines and Medical Devices Bill
Lord Lexden ExcerptsMonday 19th October 2020
(3 years, 6 months ago)
Grand CommitteeRead Full debate Medicines and Medical Devices Act 2021 View all Medicines and Medical Devices Act 2021 Debates Read Hansard Text Read Debate Ministerial Extracts Amendment Paper: HL Bill 116-I Corrected Marshalled list for Grand Committee - (15 Oct 2020)
The Parliamentary Under-Secretary of State, Department of Health and Social Care (Lord Bethell) (Con)
My 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.
The Deputy Chairman of Committees (Lord Lexden) (Con)
I have received a request to speak after the Minister from the noble Lord, Lord Patel.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, a short adjournment has been requested by the Government. The Committee will adjourn for 15 minutes.
The Deputy Chairman of Committees (Lord Lexden) (Con)
My Lords, we now come to the group beginning with Amendment 2. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during debate.
Amendment 2
Health Protection (Coronavirus, Restrictions) (North East of England) Regulations 2020
Lord Lexden Excerpts(3 years, 6 months ago)
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The Deputy Speaker (Lord Lexden) (Con)
I call the next speaker, the noble Baroness, Lady Thornton. I am sorry—it is the noble Lord, Lord Hunt of Kings Heath.
Lord Hunt of Kings Heath (Lab)
My Lords, thank you. Surely, the Minister was right to open by emphasising the gravity of the situation, but here we are again debating regulations that have already been superseded, which serves to underline the unsatisfactory nature of how we are dealing with local Covid lockdown regulations. I do not want to go over the grounds of my PNQ on Friday, but, when Mr Speaker called for the most significant of these regulations to be debated in Parliament at the earliest possible point, I think he spoke for the great majority of parliamentarians.
As the Minister has said, the Government propose to introduce a new tiered system of restrictions for local lockdowns, and, whatever the justifications for them—the noble Lord is right about the evidence that we are facing—they involve a serious reduction of people’s liberties and, of course, put many businesses in jeopardy. I am in no doubt that this House should be asked to approve them before they come into force, just as the Commons is likely to do. My understanding is that that is now likely, and, if so, this is very welcome.
Of course, the relationship between government and local authorities is highly relevant to this and the regulations the noble Lord spoke to today. Right from the start—going back to March—the Government seemed to exclude local bodies from the key part that they could have played in helping to combat and manage the virus. Public health directors were ignored, NHS and university lab capacity was overlooked and, as the Institute for Government has pointed out in its analysis of government decision-making:
“The decisions on lockdown and school closures were taken and introduced swiftly, and with little consultation and planning for how they would work in practice.”
I was very struck by a comment made by the Newcastle City Council leader Nick Forbes a few days ago. He said that confusion over the latest restrictions was deeply unhelpful and that they were very difficult to enforce and had left dangerous conspiracy theories to fill the void. We know that a frequent complaint of many leaders is that local authorities were often given little notice of when local regulations were to be made.
In parallel to the new regulations that we will debate later this week, it has been reported that the Prime Minister wants local leaders to help shape the package of local lockdown measures. Clearly, as a principle, that is welcome. Does the Minister agree that, generally, evidence shows that, globally, countries that rely on a central approach are not as effective as those that use trusted local bodies? Does he also accept that local authority test and trace services seem to have a much higher rate of contact, both for complex and non-complex cases, than the national scheme, which faces so many problems? Can he also expect to see the ending of decisions on lockdowns being leaked in advance of local leaders being told what is in them?
It is clearly important that the rules are complied with. Will the noble Lord say something about compliance rates? I do not know whether he has studied the recent report of the C19 National Foresight Group, which has been looking at the communications the Government have with the public over these restrictions. It concluded:
“National Integrity and Trust is Being Eroded”
because of the
“style, pace and timings of communications”.
It says:
“This mostly focussed around rhetoric, over-promising and timing (where late night national announcements created negative impacts on the relationship with the public). Apparent conflicting activities (where two announcements seem to contradict) and stating ambitious targets that are then not achieved were aligned to eroding trust with the public.”
Regarding local bodies, the C19 group went on to say:
“The lack of trust in the local structures from ministers and government departments… also impacts on their ability to feel included as part of a greater UK wide management”
of the pandemic. Does the Minister recognise this, and will this be considered as part of the recasting of the relationship between the Government and local authorities?
The Deputy Speaker (Lord Lexden) (Con)
My Lords, I apologise again, particularly to the noble Lord, Lord Hunt, and the noble Baroness, Lady Thornton. I was looking at the list for the next debate. I call the next speaker for this debate, the noble Lord, Lord Greaves.