Independent Medicines and Medical Devices Safety Review: Sodium Valproate

Lord Bates Excerpts

Tuesday 2nd March 2021 Lords Chamber

[Lord Bethell (Con)]

The noble Lord puts it extremely well and I totally agree with the thrust of his point. For patients to have the right information about the risks of the medicines that they are prescribed is essential. However, if I may stray into a different subject, there is also patient choice. For many patients, sodium valproate provides an incredibly valuable relief from epilepsy and mental illness. It is a drug that continues to be prescribed because some have no choice and there is no valid alternative to the drug. The number of people being newly prescribed the drug—new starters—is down dramatically from previous years, but for some it really is an important part of their therapy. The decisions that they make are personal ones, and we should respect those.

[The Deputy Speaker (Lord Bates) (Con)]

With apologies to the noble Baroness, Lady Browning, the time allowed for this Question has now elapsed.

Future of Health and Care

Lord Bates Excerpts

Tuesday 23rd February 2021 Lords Chamber

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

My Lords, I thank the two noble Baronesses enormously for those thoughtful and helpful questions. We are at a very early stage in the process of this important legislation, and the questions from both the noble Baronesses, Lady Brinton and Lady Thornton, are extremely helpful and make a good challenge. I will attempt to answer them as best as I can.

I reassure the noble Baroness, Lady Thornton, that we have all read the debates around the Lansley Bill carefully and learned an enormous amount from them. We greatly look forward to reminiscences from all those who were there in those days. There are some things that the Lansley Bill did that left an important and lasting legacy, and it would be wrong to overlook those. The establishment of Healthwatch and a focus on outcomes was a cultural inflection point in the history of the NHS. The overall importance of commissioning will not be lost in any changes introduced by this Bill. Lastly, this Bill massively builds on the establishment of NHS England in its measures. These are some examples of where the Lansley reforms made huge advances.

However, as the noble Baroness, Lady Thornton, rightly pointed out, some of those reforms have had their day and it is now important to move on to the next round, building on those reforms while fine-tuning some of them. One of the most important areas of development is around collaboration. By that, I mean that the challenge of modern healthcare is to bring a huge amount of expertise and extremely complex resource to bear on individual patient challenges. The sheer complexity of some of the treatments and therapeutics that can benefit the patient requires not just simple clinical analysis by an individual but teams across many disciplines, sites and, sometimes, institutions. It is the bringing together of that huge amount of collaboration that the Bill focuses on.

The noble Baroness is right that we face massive challenges in the period ahead. The vaccination programme is absorbing a huge amount of resource. There is a tremendous backlog in almost every area of the NHS and getting through it is a great challenge. NHS staff themselves are tired and exhausted; they deserve a break. This should not hold us back from doing exactly what the NHS had planned to do before the Covid epidemic, what stakeholders in the NHS repeatedly tell us that they want to do and what the huge amount of engagement that we have done tells us is right to do. I remind her that the core of the White Paper is the proposals made by the NHS to the Government in September 2019 to help the NHS deliver its long-term plan.

NHS England and NHS Improvement carried out a huge engagement process before making those recommendations. That exercise had over 190,000 written responses from individuals and organisations representing different parts of the health and social care system. Those recommendations were supported and endorsed by key leaders across that system, including NHS Providers, UNISON, Healthwatch, the Local Government Association, the Royal College of Nursing and many others. The recommendations made by NHSEI also built on recommendations made by the Health and Social Care Select Committee in June 2019.

The Bill will have been thought about and prepared for over many years. It is the thoughtful application of important reforms and therefore deserves the close analysis and support of noble Lords. There are tremendous benefits to patients. The noble Baroness, Lady Thornton, specifically asked what the tangible benefits are, and I will pull out three in particular.

First, there are some specific public health measures in the Bill. As the noble Baroness, Lady Brinton, rightly raised—I will come back to it, in a moment—public health is central to the outcomes of the Bill. Fluoridation is the iconic measure, but a thick red thread of public health runs throughout the Bill. Secondly, the constitution of the Healthcare Safety Investigation Branch—HSIB—will, with statutory muscle, bring about the important investigatory element to promote the patient safety agenda, which my noble friend Lady Cumberlege wrote about in her report. Thirdly, the bringing together of GP and social care services into integrated care systems will bring much closer the decisions about patients which often cross barriers that, I am afraid, are huge obstacles to effective care today.

I will address the question of social care directly because the noble Baronesses, Lady Brinton and Lady Thornton, challenged me on this point: why have we not in the Bill brought about a wholesale financial rebooting of adult social care? The measures on adult social care in the Bill are just one aspect of a wider reform agenda. Our wider objectives for social care are to enable an affordable, high-quality and sustainable adult social care system that meets people’s needs while, supporting health and care in joined-up services around people. The Prime Minister has been crystal clear about his agenda for reform. A broad range of options are being explored on how best to accomplish these reforms and we want to ensure we get that reform right. Engagement with the sector and the public will be an important part of that.

We are still considering a number of funding reform options. However, the leading options, such as a cap and floor, are already provisions in the Care Act so they require only secondary legislation to enact. For this reason, we do not require anything on charging reform to be included in the Bill. However, the Bill should be considered as an important paving stone to wholesale social care reform.

I entirely agree with the noble Baroness, Lady Brinton, that culture is important. We are absolutely committed to putting social care in exactly the same hierarchy as the NHS. We believe that local authorities have a central role in the provision of social care; that is envisaged to remain the same. The noble Baroness, Lady Thornton, asked specifically: who will sit on the boards? That is exactly the kind of question that I look forward to debating here in the House and engaging on with noble Lords.

The noble Baroness, Lady Thornton, asked about competition, and she and the noble Baroness, Lady Brinton, raised deep-seated and heartfelt concerns about cronyism and corruption. I take those concerns very seriously. Huge amounts of taxpayers’ and voters’ money have been employed during the pandemic in the fight against Covid, and very large sums of money were spent on PPE in circumstances where there was a huge rush and difficult arrangements were being put in place. However, I remind both noble Baronesses that when they attack the Government and make accusations of cronyism, chumocracy and corruption but have no foundation for those attacks, they are interpreted as attacks on the very NHS and social care staff who have worked extremely hard to procure the right services and products, who have the interests of patients in mind, and who are working so hard to save lives. Attacks on the integrity of the system are extremely damaging to their morale and the integrity of that system. I kindly ask the noble Baronesses, Lady Thornton and Lady Brinton, who have made these attacks repeatedly over the last few months, to think very carefully about the way in which they make these accusations.

In particular, I will address the question raised by the noble Baroness, Lady Brinton, of PPE being taken from lorries that was destined for social care and sent instead to the NHS. If she indeed has evidence that such a thing happened, I would be very grateful if she would write to me. But if she does not, I would be extremely grateful if she did not raise this anecdote again, because it is a damaging image which hurts very much those who work in social care and the NHS, and is not necessarily fit for a debate such as today’s.

In terms of the PPE contracts that were the subject of a recent action in the law courts, I will repeat the sentiments expressed by my right honourable friend the Secretary of State for Health. Every waking moment of every day for everyone involved in the procurement of PPE was dedicated to getting the right kit to people on the front line to save their lives. If the paperwork was done two weeks late, that is an entirely proportionate and reasonable consequence of a very difficult situation, and seeking to make political capital out of an administrative oversight does not seem at all proportionate to the situation.

This is an extremely exciting Bill we have before us. I very much look forward to debating it in this Chamber. I am extremely grateful to the noble Baronesses, Lady Brinton and Lady Thornton, for their questions.

[The Deputy Speaker (Lord Bates) (Con)]

My Lords, we now come to the 20 minutes allocated for Back-Bench questions. I ask that questions and answers be brief so that I can call a maximum number of the 16 speakers who have asked to ask questions in response to this Statement.

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[Lord Bethell (Con)]

My Lords, I agree with the noble Baroness that there is a challenge around parity of status. The pandemic has vividly brought alive the challenging circumstances of those who work and live in social care. It is a tremendous tribute to the British people that they have given the lives of the elderly and the vulnerable such a high priority by putting the life of the country on hold to protect the health of the vulnerable and elderly, and that they have thought carefully and thoughtfully about those who live in either residential or domiciliary social care, for instance. It has brought alive for the whole nation the circumstances of those who live in social care.

I have heard loud and clear those in this House who have made the case for those who work in social care, often in low-paid roles but with a huge amount of responsibility and a massive task ahead of them, to receive better training, have clearer career paths, and, as the noble Baroness rightly points out, have a higher status. However, I do not agree with her that the sequence should be financial reform followed by structural reform. With this Bill, we are trying to put in the correct structural circumstances for social care so that it has parity with the NHS and a collaborative jigsaw fit with those in clinical and public health roles. Therefore, when the financial reforms are put in place, they will be done most effectively and with the largest impact.

[The Deputy Speaker (Lord Bates) (Con)]

My Lords, I am afraid that the time allowed for Back-Bench questions has now expired, with apologies to the noble Lord, Lord Vaizey, and the noble Baronesses, Lady Barker, Lady Stuart, Lady Donaghy and Lady Jolly, that I was not able to call them.

House adjourned at 7.52 pm.

Covid-19 Vaccines Deployment

Lord Bates Excerpts

Thursday 11th February 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I am enormously grateful for the thoughtful questions from the noble Baronesses. They are entirely right to applaud the progress of the vaccine. I start by sharing some pretty formidable statistics on that. An absolutely remarkable 95.6% of those aged 75 to 79 have received their first dose. I have never seen a government statistic quite like that. It is an astonishing figure. Such a very large proportion of a target population have come forward, have been efficiently vaccinated and are now protected from the worse effects of this awful disease. It is an enormous success story. Of those over 80 years old, 91.3% have received their first dose and 74% of 70 to 74 year-olds have received their first dose. Up to 9 February, an astonishing 13,580,298 people received their vaccine. These are extraordinary figures. It will have a huge impact not just on the personal lives of those who have been vaccinated and their families but on the workings of the entire NHS. It is a massive game-changer and will dramatically reduce the amount of hospitalisation for and deaths from Covid. We are determined to take full advantage as a country of this enormous success story.

We are enormously pleased with the WHO readout on the AstraZeneca vaccine. It is exactly what we hoped for and what we understood from the clinical trials of the vaccine, and it is pleasing to see worldwide recognition that a 12-week gap between the two doses is the right approach and that the AstraZeneca vaccine is good for over 65 year-olds. I greatly thank those at the WHO who have done that. We are completely committed to the vaccine rollout and we will not take our foot off the pedal in any way.

I completely understand the point of those who are concerned about the impact of the lockdown. The noble Baroness alluded to the words of Charles Walker, who is entirely right that the lockdown has a huge impact on the economy, the public mood and particularly on those who cannot make it to school. However, the approach we are taking—a slow and steady approach of not rushing into anything—is exactly the one that will pay the greatest dividends for the economy. It is hugely supported by the general public and it will mean that, when we release the lockdown and return children to school, we can do it with the confidence that we will not have to go back again.

We are concerned about the lag in take up, particularly in black African communities. There are clearly, among the really good stories of take up, one or two areas where we are concerned. The work of the communications team on anti-vaxxers’ stories and the support we have got from social media firms has been really good across the board, but this is one area where we are enormously focused. The data is not always crystal clear, and we have not published it all yet, but this is one area where the noble Baroness is entirely right and we are very concerned.

The noble Baroness asked for reassurance on the second dose: will everyone get a second dose, and are there enough supplies in the warehouses for everyone? I reassure her and all noble Lords who may be concerned on that point that we are absolutely committed to the second dose. Everyone will get it, and they will get it on time. The supplies are in place.

The noble Baroness, Lady Brinton, asked about whether it was our policy to give a difference second dose to the first. I will be crystal clear: this is not our policy. If you are given a dose of “A” then your first dose will be “A” and your second dose will be “A” as well, and not “B.” We are looking into clinical trials that seek to understand whether an “AB” combination might be safe and may even be better. There are examples in other spheres where mixing two different vaccines can have a benign effect on the body and can stimulate a greater antibody response. We are looking at this very carefully. The COM COV clinical trial has been given £7 million to look into this. It is a long-term clinical trial and we are not expecting a readout any time soon but, if there are benefits, we will chase those down.

I completely agree with the noble Baronesses, Lady Thornton and Lady Brinton, on variants of concern. We have all been alerted to the grave danger that a mutation might have enhanced transmissibility, increased severity and escapology. Should such a variant emerge that could somehow jeopardise the Ming vase of our massive vaccination success story, we would be extremely concerned to address it. We are shortly having a debate on borders, and I shall save my comments for that debate, but I completely endorse the concerns of both noble Baronesses.

The noble Baroness, Lady Brinton, mentioned Professor Chris Whitty. To all those who missed it, I mention the presentation he gave yesterday on the investment in therapeutic drugs and antivirals, which was unbelievably impressive. We are enormously lucky to have someone like Chris as our Chief Medical Officer. Indeed, the Deputy Chief Medical Officers, Jonathan Van-Tam and the others, have all served us extremely well. I also praise others who have stepped up to public life in our time of need, including Kate Bingham and the noble Baroness, Lady Harding. They have both done an enormous public service and deserve enormous praise.

The noble Baroness, Lady Brinton, asked about disabled people. She is entirely right: there are those who are disabled or who have learning difficulties, and we are concerned about the impact of Covid on them. Many who are clinically extremely vulnerable are already in the priority level 4 and will already be in the prioritisation list. Others will be in prioritisation level 6. We are looking at whether we should change the prioritisation system in any way, and the JCVI keeps a running watch on this. I reassure the noble Baroness that all those in a high-risk group will be prioritised in a reasonable fashion. We will be reaching prioritisation level 6 very soon indeed.

The noble Baroness, Lady Brinton, talked about the importance of sharing vaccine with other countries. Tedros is absolutely right: we are not safe until everyone is safe. Britain has taken leadership role in CEPI, Gavi and ACT; we continue to support the global distribution of vaccines through our contribution of IP, our massive financial contribution and our diplomatic leadership. We remain committed to that, and we will continue to use our chairmanship of the G7 to influence other nations to step up to their responsibilities.

[The Deputy Speaker (Lord Bates) (Con)]

My Lords, we now come to the 20 minutes allocated for Back-Bench questions. I ask that questions and answers be brief so that I can call the maximum number of speakers.

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[Lord Bethell (Con)]

My Lords, the honest truth is that I cannot lay out a timetable for my noble friend. That will happen in the week of 22 February and the Prime Minister has made that clear. He is entirely right that the vaccine dramatically reduces hospitalisation and death. Target groups 1 to 4 account for nearly 90% of the deaths, so this is a dramatically improved situation. However, it does not remove the threat of Covid altogether. At the moment we have an infection rate of around 2% in the country. Were we to open up tomorrow, that infection rate might lead to a much higher rate: 10% or 20%. If we ran at a rate of 20% we would have a very large number of young people who would end up in hospital one way or the other, and who might experience long-standing damage from the Covid disease. We would also increase the rate of mutations in our own country and we would have a great displacement of that effect on the rest of the NHS system.

So this is not a binary game in which we have suddenly hit the moment where we can lift everything. We have to tread cautiously on that. However, I agree with my noble friend that the mental health impact of the lockdown is intense. I reassure him that two members of the SAGE subgroup SPI-B are members of the British Psychological Society. SPI-B presents the independent expert behavioural science to advise the top SAGE—the Scientific Advisory Group for Emergencies—and it brings to the debate a very clear insight on mental health and brings to our awareness the impact of lockdown, which, as my noble friend quite rightly points out, is immense.

[The Deputy Speaker (Lord Bates) (Con)]

My Lords, the time allowed for Back-Bench questions on this Statement has now elapsed. I apologise to those whom I was unable to call. There will now be a short pause to allow for some changes before taking the second Statement.

Social Care Funding (EAC Report)

Lord Bates Excerpts

Thursday 28th January 2021 Grand Committee

[Baroness Hollins (CB) [V]]

My Lords, I refer to my interests in the register. I thank the noble Lord, Lord Forsyth, for steering this excellent report. We can no longer ignore the impact that chronic underfunding and political indecision about adult social care are having on the well-being of individuals—something the pandemic has shone a spotlight on.

First, I question whether it is possible sensibly to debate social care for older people at the same time as social care for working-age disabled adults, who are far too often overlooked in debates on social care reform. Perhaps older adults have more political clout. It does not make sense to ignore or exclude a group which, according to the Association of Directors of Adult Social Services, accounts for 64% of demographic pressures on the sector and approximately half of social care spending in England—I know that the noble Lord referred to this.

Secondly, we need a two-way collaboration between health and social care: interdependence rather than dependence. The NHS cures us of disease and mends bones; social care helps to cure loneliness, mends social inequalities and unlocks potential. For social care to achieve its mission, it must have personal fulfilment and independent living at its heart. For many working-age disabled adults, social care is not personal care but rather the support to develop skills such as cooking and maintaining a home so that they are able to make meaningful decisions about how to live their life and to grow in confidence, perhaps to find employment, to make friends and to play an active role in the community. Proposals that include funding mechanisms based on housing wealth, assets, floors, caps and insurance seem to forget about the impact that such models could have on working-age disabled adults. While free personal care would undoubtedly benefit many people, one concern is that underfunding could facilitate a drift towards the medicalisation of social care, where individuals’ horizons are reduced and the goal of the system becomes merely to keep someone alive.

Thirdly, social care must have a better-paid and trained professional workforce, with a meaningful career structure to reward dedicated staff and producing a talent pipeline that creates an avenue for experienced staff to develop, become mentors and pass on their knowledge and skills to a new generation. We know the problems that plague the workforce, including that some people take short-term jobs to fill employment gaps, but it is mainly that low pay and poor career progression lead to high turnover and poor retention. With more than 100,000 vacancies, we cannot underestimate the challenge. These problems are not new. In 2016, I chaired an expert reference group for Health Education England on building a direct support workforce to deliver the transforming care programme for people with a learning disability and/or autism who display behaviour described as challenging. Without adequate support and effective collaboration between social care and community mental health services, that group faces a real risk of ending up in inappropriate in-patient units at huge cost, both personal and financial. Of course, many people post Covid will want to avoid congregate care settings. This will need a different approach to career development and career structures.

The social care sector needs an immediate injection of funding to help improve pay and stabilise the sector, as many have already said, as well as reform in the ways that I have briefly outlined with respect to working-age disabled adults.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

Before I call the noble Lord, Lord Taylor, I remind all participating remotely to keep their microphones on mute unless they are called to speak.

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[Baroness Pitkeathley (Lab) [V]]

My Lords, I declare my interest as vice-president of Carers UK. I am greatly indebted to the noble Lord, Lord Forsyth, for finally securing this debate and very pleased to participate—as pleased as I was, in fact, when I first read the report in July 2019, not just with its content but mostly that it existed at all.

In the 23 years I have been in your Lordships’ House, I have taken part in many debates on social care and have been wont to call those who join me “the usual suspects”. We were a relatively small band who banged on about this subject whenever we got the opportunity and frequently used the expression “a national scandal”, as it is used today. I have to tell your Lordships that it makes pretty depressing reading to go back to those other debates on social care because the problems remain the same and so little progress seems to have been made. But the noble Lord, Lord Forsyth, and his colleagues are not the usual suspects and they reached the same conclusions.

The committee found a situation which, I think it is safe to say, shocked its members. If it was bad in the summer of 2019, how much worse is it now after the ravages wrought by the pandemic? The situation is bad for everyone: for local authorities, for the NHS and for care homes. It is very bad for family carers, as the report acknowledges. We all know now that families and friends are holding the social care system together by providing support for the most vulnerable in society. Many were at breaking point before the current crisis and are now sick with worry. We are asking even more of these unpaid carers than ever before. They urgently need to be supported and their contribution, worth billions of pounds, recognised.

If Covid-19 and the additional focus it has brought on the inadequacy of the care system have any positive outcome, it may be that we are finally forced to take bold decisions about the funding and provision of social care. Over the years, we have all witnessed the endless recommendations about how to reform the system: the reviews, the royal commission, the unenacted legislation and, of course, the endless broken promises. What we need now is a decision of the level and quality that our forebears took in relation to the NHS, but this time it must be about reshaping health and social care around today’s needs, not those of the population of a post-war Britain.

We cannot go on as we are, trying to do more with less, managing demand by simply not meeting it and by being dishonest with the public and the voters. No Government have ever made it clear to the public that responsibility for paying for and arranging care rests with individuals and their families. If they are not prepared to reform the system, the Government must at least be prepared to promote clearer public understanding of how the system works, what people can expect and, more importantly, what they cannot expect.

This problem is not going to go away; it is only going to get worse. The question is not whether these costs will arise, but how they will be met. Will they be met by the public purse or by private individuals? Every independent review of the past 20 years has recommended that future funding of social care, as well as healthcare needs, should come from public, not private, finance. The needs of individuals cannot be divided up neatly into health or social care needs. The time for debate is surely over. We have enough research and experience to enable us to take this decision—to decide on reform. All we need is the will to do so. If we have the will, we can end this national scandal now.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I now call the next speaker, the noble Lord, Lord Campbell, after whom I will call the noble Lord, Lord Lansley.

Mental Health Act Reform

Lord Bates Excerpts

Monday 18th January 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, that is not the intention of the report, and I confess to struggling to understand how that would be the case. I would welcome correspondence from the noble Baroness to detail her concerns so that they can be taken on board.

[The Deputy Speaker (Lord Bates) (Con)]

I call the noble Lord, Lord Singh of Wimbledon. No? Lord Boateng.

[Lord Boateng (Lab) [V]]

My Lords, the Minister is to be commended for calling out racism, because that is what many black and south Asian patients experience. Will he ensure that commissioners in the field, with this new money given to them, fund local, community-based advocacy groups? And will he ensure the health review tribunals reflect the communities on which they are adjudicating and recognise racism in the mental health service?

Medicines and Medical Devices Bill

Lord Bates Excerpts

Report stage & Report stage (Hansard): House of Lords & Report: 1st sitting & Report: 1st sitting: House of Lords
Tuesday 12th January 2021 Lords Chamber

Amendment 11 agreed.

[The Deputy Speaker (Lord Bates) (Con)]

We now come to the group consisting of Amendment 13. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press the amendment to a Division must make it clear in the course of the debate.



Clause 2: Manufacture, marketing and supply

Amendment 13

Moved by

Covid-19 Vaccine Rollout

Lord Bates Excerpts

Wednesday 9th December 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, the precise status of each vaccine in the pipeline is a subject for dialogue between the vaccine manufacturers and the MHRA. I can tell the noble Baroness that we are extremely encouraged by the substantial number of vaccines in the pipeline. The safety data for all those for which we know the response is also extremely encouraging. AstraZeneca—the one that most eyes are on—is making good progress, but I am afraid that I cannot give a clear or confirmed time for when, or if, it will be authorised. As for doses, as the noble Baroness probably knows, we have committed to more than 320 million doses overall. The precise details of those are published on the Vaccine Taskforce website, and I would be glad to send her a link to that, so that she can get all the details.

[Lord Bates (Con)]

I thank my noble friend for this very good news, and for his tireless work in keeping us informed. Throughout this crisis, we have been given an object lesson in who are truly the key workers in our society, such as those working on farms and in supermarkets, and those servicing utilities, cleaning streets, organising deliveries and keeping us safe. Will he ensure that this lesson is remembered when ordering the front of the queue for the rollout of the vaccine?

[Lord Bethell (Con)]

I am grateful to my noble friend for his kind comments, and endorse his tribute to all those who have worked hard on the front line of healthcare during this pandemic, at times putting themselves at risk, and all of them under great stress. We owe them enormous gratitude. The JCVI has made a clear priority list and advised that the first priorities for any vaccination programme should be the prevention of mortality and protection of healthcare staff and systems. Therefore the vaccine is being rolled out to the priority groups, including care home residents and staff, people over 80, and healthcare workers. They are the ones who will be at the top of the list, and that seems to me proportionate, fair and right. As we work through the later prioritisations, others in the population will have access to the vaccine.

Medicines and Medical Devices Bill

Lord Bates Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

Relevant documents: 19th Report from the Delegated Powers Committee, and 10th Report from the Constitution Committee

[The Deputy Chairman of Committees (Lord Bates) (Con)]

A participants’ list for today’s proceedings has been published by the Government Whips’ Office, as have lists of Members who have put their names to the amendments or expressed an interest in speaking on each group. I will call Members to speak in the order that they are listed. Members are not permitted to intervene spontaneously; the Chair calls each speaker. Interventions during speeches or “before the noble Lord sits down” are not permitted.

During the debate on each group I will invite Members, including Members in the Grand Committee Room, to email the clerk if they wish to speak after the Minister, using the Grand Committee address. I will call Members to speak in order of request and will invite the Minister to respond each time. The groupings are binding and it will not be possible to degroup an amendment for separate debate. A Member intending to move formally an amendment already debated should have given notice in the debate. Leave should be given to withdraw amendments.

When putting the Question, I will collect voices in the Grand Committee Room only. I remind Members that Divisions cannot take place in Grand Committee. It takes unanimity to amend the Bill, so if a single voice says “Not content”, an amendment is negatived and if a single voice says “Content”, a clause stands part. If a Member taking part remotely intends to oppose an amendment expected to be agreed to, they should make this clear when speaking on the group.

Amendment 49

Moved by

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[Baroness Penn (Con)]

My Lords, I recognise that there is keen interest in how we may use powers in Clause 2(1)(n) of the Bill, relying on Clause 1(1), to continue to update the prescribing and supply responsibilities of healthcare professionals. However, I hope to persuade noble Lords that Amendment 49, in the name of the noble Baroness, Lady Thornton, is unnecessary.

I am very pleased to say to noble Lords that NHS England and NHS Improvement are already leading work to scope the current and potential future use of medicines supply, administration and prescribing mechanisms by a range of non-medical healthcare professionals. On 15 October, they started consulting on a range of proposals to extend medicines administration and supply responsibilities, and to update the medicines that some existing independent prescribers may prescribe.

The consultations cover the use of patient group directions by biomedical and clinical scientists and operating department practitioners, exemptions enabling dental therapists and hygienists to supply some medicines, and changes to the controlled drugs that can be prescribed by physiotherapists, podiatrists and paramedic independent prescribers. If progressed, these proposals would allow patients to get timely and safe access to medicines from the most appropriate healthcare professionals, without the need for extra appointments from other prescribers, such as a GP. The current consultation will run until 10 December and is of course a public consultation. It will be informed by the views of key patient and professional groups, with engagement starting shortly through a series of online events.

I reassure noble Lords that we are committed to updating the prescribing and supply responsibilities of professional groups, where it is safe and appropriate to do so. In keeping with the rest of the Bill, any such changes will be made in a way that serves the best interests of patients. The powers allow us to ensure that professional responsibilities can be updated to reflect developments in professional practice, new approaches to care, changing scientific understanding and growing technical abilities. This ensures that we can continue to make full use of the skills available to us among NHS professionals, and support patients to receive the best possible care and support from NHS staff.

I know that a number of NHS professional groups are keen to see their members taking on responsibility for supplying or prescribing medicines. We have recently seen papers put forward by the British Dietetic Association, the Royal College of Occupational Therapists, the British and Irish Orthoptic Society, the Society of Radiographers and the Royal College of Speech and Language Therapists. I am very grateful to the professional groups for the careful consideration that they have given to these issues.

I reassure noble Lords that NHSE/I already has extensive joint working and engagement under way with these and other professional groups to consider whether any other changes would help keep patients safe and well. This will build on the historic work with various professional bodies and the devolved Administrations, over the last few years, which resulted in a number of changes, including allowing paramedics and therapeutic radiographers to be independent prescribers. As well as this, a wider scoping project is being led by NHS England and NHS Improvement, with the devolved Administrations and professional bodies, on the current and potential future use of medicines supply, administration and prescribing mechanisms by a range of non-medical healthcare professionals.

I also reassure the noble Baroness, Lady Thornton, the noble Lord, Lord Hunt, and other noble Lords who raised this that NHS England and NHS Improvement’s work on prescribing and supply will of course account for lessons learned from the Covid-19 response. For instance, NHSE/I wishes to learn from professional bodies and, in its scoping work, is asking them how the use of medicines mechanisms contributed and how they can play a role in increasing capacity to respond to future challenges. On that basis, I hope that the noble Baroness, Lady Thornton, feels able to withdraw her amendment.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I have received no requests to speak after—

[Baroness Thornton (Lab)]

I actually just sent in my name.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

Oh, right. I have received one request to speak after the Minister. I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

I am sorry; it was possibly delayed. It was really just to ask the noble Baroness: when is the earliest she thinks there will be change? Are we looking at three months, six months or a year?

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[The Deputy Chairman of Committees (Lord Bates) (Con)]

We now come to the group consisting of Amendment 62. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Clause 9: Manufacture, marketing, supply and field trials

Amendment 62

Moved by

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Clause 11 agreed.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

We now come to the group beginning with Amendment 67A. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the course of the debate.

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I hope that the noble Baroness, Lady Jolly, will feel able to withdraw her amendment, and that others will not feel compelled to move theirs.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I have received one request to speak after the Minister. I call the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

I merely wish to ask the Minister about the consolidation legislation, to which he referred. Am I to understand that the Minister is saying that the Secretary of State will respond to Parliament, and that the matter will be available for debate?

Medicines and Medical Devices Bill

Lord Bates Excerpts

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

I hope that the noble Baroness has heard enough to feel able to withdraw Amendment 3 and that other noble Lords with amendments in the group will not press theirs.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I have received a request to speak after the Minister from the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

My Lords, the Minister referred to the large number of trials that are started in the United Kingdom. Can he say how many phase 3 trials have been started here? He also referred to the platform that the MHRA has developed with regard to Covid that accelerated the delivery of drugs, which is correct. However, that is not the same as a platform for rare diseases.

I agree that the licensing that was done at speed, within six months, would normally have taken two years: for instance, the licensing of the use of Remdesivir, produced by Gilead Sciences for the treatment of Covid-19. However, that is not the same as the noble Lord’s implication that it could be used for rare diseases. Those require a larger database, which Covid had, because there is no shortage of Covid data. Furthermore, he said that the EU portal means that individual countries have to approve. That is correct, but the approval is a speedier process because it has gone through the portal, unlike before.

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Amendment 3 withdrawn.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

We now come to the group beginning with Amendment 4. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the course of the debate.

Amendment 4

Moved by

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[Baroness Penn (Con)]

My Lords, it is perhaps appropriate if I begin by speaking to the government amendments—Amendments 43, 44, 64 and 65 in the name of my noble friend Lord Bethell —in this group. In doing so, I thank my noble friend Lord Blencathra for his committee’s report. As previously noted, we have listened to that report, and the changes that we propose through these amendments are intended to address the specific concern in that report regarding penalties for existing criminal offences.

As drafted, Clause 5(1)(b) already provides a restriction limiting the maximum penalty to imprisonment for two years when creating a criminal offence. The DPRRC asked us to explain whether the penalties for existing offences could be amended when there was no maximum specified in the Bill. I want to be clear that we do not intend to increase the penalties for existing offences.

Amendments 43 and 44 would work together to amend Clause 5. They make it clear that, under Clause 1, we may not make regulations that provide for a criminal offence to be punishable by more than two years’ imprisonment. This will apply to both new and existing criminal offences. For veterinary medicines, Amendments 64 and 65 seek to achieve the same by amending Clause 10.

The government amendments will, I hope, remove any concern that powers in Clauses 1 or 8 could be used to make regulations extending sentences for existing offences beyond two years’ imprisonment.

I now turn to Amendment 4 and the other amendments in this group to which noble Lords have spoken. The ability to enforce breaches of the regime governing medicines is a power originally conferred on the Secretary of State in the interest of protecting public health. This was introduced by the Medicines Act 1968 and provisions around offences are found throughout the Human Medicines Regulations 2012. They are also contained in the Veterinary Medicines Regulations 2013.

Offences deter potentially harmful activity and make it possible to take punitive measures against those whose actions put people, animals and the environment at risk. As we make necessary updates to the regulatory requirements, we must be able to remain consistent with the current enforcement regime, which already imposes criminal sanctions. It would not be right that a person may face a criminal sanction for breaching current requirements but not for breaching new regulatory requirements, for example relating to novel technologies and medicines. As with other changes to provisions, making changes to offences will be subject to the draft affirmative procedure, and we will make offences proportionate and necessary. It is imperative that we are able to balance novel regulation with enforcement of that regulation.

It cannot be ignored that crime involving medicines is increasing. Furthermore, criminal activities adapt to new environments and technology. In recent months we have seen opportunistic criminals selling online unauthorised and unapproved medicines and devices for the treatment, prevention or diagnosis of Covid-19, including antimalarials, self-testing kits, “miracle cures” and “antiviral misting sprays”, which could cause harm and unnecessary stress to patients. Enforcement capabilities must be able to keep pace with criminal exploitation. Delegated powers afford us our continued ability to enforce the regulatory requirements for medicines and devices for public protection. To be effective, they must be enforceable.

The Veterinary Medicines Regulations 2013 contain numerous criminal offences for breaches of the regulations; again, this is for the purposes of enforcement. The Veterinary Medicines Directorate’s enforcement strategy is risk-based; it focuses on proportionality, consistency, transparency and targeting. The VMD works with businesses and individuals to assist them in complying with the legislation through the provision of advice and guidance. However, where necessary the VMD will use more formal means of enforcement to secure compliance. It is critical that we have the delegated powers to enforce this.

We have always been clear that we are trying to provide greater clarity on how to enforce the regulations on medical devices. The regulator’s ability to have teeth when we are looking to raise medical device safety standards in future is essential. The report from my noble friend Lady Cumberlege tells us that.

The Bill is also clear on the maximum time limit for imprisonment, which applies to any new criminal offence introduced. This limit matches the current system for devices, where criminal offences for medical devices are already punishable for up to six months. The devices regulations are in place to protect public health; breaches of those regulations put people at risk and can cause significant harm. It is only appropriate that there is a clear consequence for any such actions, including potential criminal prosecutions. We will of course have regulations subject to the duty to consult at Clause 41, which will mean the public have the opportunity to comment on the necessity and proportionality of the approach.

I hope the necessity of enforcing the new regulations, and the safeguards the government amendments have provided, persuade the noble Lord to withdraw his Amendment 4 and others not to move theirs.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to respond to the debate on his amendment.

[Lord Hunt of Kings Heath (Lab)]

I first thank my noble friend Lady Thornton for her words in support of the amendment and the noble Lord, Lord Patel, who was hoping to field an impressive cast list in this debate. I thought he did very well; I have always thought he would make a first-class lawyer—he should take that as a compliment.

At the heart of it, as he and the noble Lord, Lord Sharkey, said, this is a constitutional point: the advice we have had from a House of Lords Select Committee is that what the Government are proposing is constitutionally unacceptable. While the Minister’s amendments are always welcome, the fact remains that the Bill, after the Government’s amendments, would allow Ministers to create completely new criminal offences and make changes to existing offences. The Minister kindly explained this, but here we get to the heart of this Bill and the problem that many of us have with it. She talked about novel regulation and the need to keep pace with developments. I understand that.

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[The Deputy Chairman of Committees (Lord Bates) (Con)]

We now come to the group beginning with Amendment 6. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate.

Amendment 6

Moved by

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[The Deputy Chairman of Committees (Lord Bates) (Con)]

My Lords, I have received one request to speak after the Minister. I call the noble Lord, Lord Patel.

[Lord Patel (CB) [V]]

I thank the Minister most sincerely for her extensive response. I understand some of the points she made. I am also grateful that she is going to write to me and other noble Lords about the definitions that I questioned in my speech.

I accept that at times the Government will need to have powers in emergencies, but some of the examples the Minister gave were not really emergencies. I made the point that in such situations government Amendment 133 and the table do not allow for parliamentary scrutiny. The fact that there is no sunset clause means that the Government will have power to make regulations under both the negative and the affirmative procedure for evermore. That cannot be right. Yes, there will be a learning process, but there should be more ability for Parliament to scrutinise.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

I call the Minister to respond to the point made by the noble Lord, Lord Patel.

[Baroness Penn (Con)]

My Lords, I believe that the noble Lord’s comments reflect the themes that we are discussing throughout our scrutiny of the Bill. I certainly take them on board with regard to this group of amendments, I believe that we have discussed them before and will discuss them again on other groups of amendments.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

Finally, I call the noble Lord, Lord Sharkey, to respond to the debate on his amendment.

[Lord Sharkey (LD) [V]]

I am grateful for the support of the noble Lord, Lord Kakkar, and the noble Baronesses, Lady Jolly and Lady Thornton, but I am disappointed that the Minister still seems to regard the affirmative procedure as constituting effective scrutiny. Let me briefly quote again the Constitution Committee, which says:

“Without a genuine risk of defeat, and no amendment possible, Parliament is doing little more than rubber-stamping the Government’s secondary legislation. This is constitutionally unacceptable.”


Neither the DPRRC nor the Constitution Committee agrees with the Government’s position on this, I think largely because it is obviously wrong. I am also disappointed that the Government seem to continue to believe that extensive consultation is equivalent to or a substitute for parliamentary scrutiny—another obviously wrong position, as the DPRRC makes clear.

As to the objection that the super-affirmative procedure is too cumbersome or lengthy, neither of these objections could have any weight unless there were some urgency. As I have explained, there is not; even if there were to be, the “made affirmative” procedure would kick in and take care of it.

As I remarked in the opening group this afternoon, at the root of all this is a desire by the Government to take powers to make policy before they have decided what that policy is. This is not only perverse but evades parliamentary scrutiny and bypasses Parliament. We will return to this issue on Report. In the meantime, I beg leave to withdraw my amendment.

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Amendment 7 agreed.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

We now come to the group beginning with Amendment 8. 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 Thornton.

[Baroness Thornton (Lab)]

May I ask for some clarification? Normally in Committee—under normal life, as it were—we would not start another group that would take at least three-quarters of an hour or so if we knew we were going to rise at a set time. I want some guidance as to why we will start this group now, when we know that we will not finish it within the time allowed. We might get through my speech and the next one, but that will be it. I am looking for guidance, Lord Chair.

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[The Deputy Chairman of Committees (Lord Bates) (Con)]

Weighty matters of this nature are dealt with by the usual channels; the Government Whip will respond.

[Baroness Penn (Con)]

My Lords, I understand that the need to rise at a set time is part of the needs of the hybrid House. With other Grand Committees that have taken place in this circumstance, we have made progress on groups and had to adjourn mid-group. That is incredibly important in order to make progress on legislation when we are operating to time-constrained sessions.

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[Baroness Thornton (Lab)]

I think we should. This is an important debate and we need it as a whole debate. I would be very grateful if that could be considered. I promise to make a small speech when we restart.

[The Deputy Chairman of Committees (Lord Bates) (Con)]

That concludes the work of the Committee this afternoon. The Committee stands adjourned. I remind Members to sanitise their desks and chairs before leaving the Room.

Committee adjourned at 7.13 pm.

Covid-19: Test and Trace App

Lord Bates Excerpts

Monday 22nd June 2020 Lords Chamber

[Baroness Wheeler (Lab) [V]]

My Lords, the PNQ refers to the lessons learned. One key one—[Inaudible]—launch of a system that was not ready and serious IT—

[The Deputy Speaker (Lord Bates) (Con)]

Order. We are having some technical difficulties hearing the noble Baroness’s question, so we will go to the next question, from the noble Lord, Lord Duncan of Springbank, and come back to her if there is time.

[Lord Duncan of Springbank (Con) [V]]

My Lords, I have listened to my noble friend and feel that confidence in the Government has been shaken by this approach. I have one question: how do we anticipate this approach now being rolled out across the four nations of the United Kingdom and how will they interface, one with another?

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[Lord Bethell]

The noble Baroness is entirely right that local councils are pivotal to our response to Covid-19. I pay tribute to Tom Riordan, CEO of Leeds City Council, for the important work he is doing to stitch together the alliance of councils which is working closely with the joint biosecurity centre to organise that response. However, I do not agree with the noble Baroness on the role of the tracing teams—it has been incredibly important. There has not been the capacity in the decentralised PHE teams to provide the response necessary to this national epidemic. A central team was necessary and is proving to be effective. We have put PHE expertise at the heart of that programme.

[The Deputy Speaker]

My Lords there are no more supplementary questions.