Medicines and Medical Devices Bill

Lord Bethell Excerpts

3rd reading & 3rd reading (Hansard) & 3rd reading (Hansard): House of Lords
Thursday 21st January 2021 Lords Chamber

[Lord Sharkey (LD) [V]]

My Lords, Amendments 1 to 8, in my name and that of my noble friend Lady Jolly, are to correct drafting. None of them, individually or collectively, alters the meaning or substance of the parts of the Bill that they would amend. I beg to move Amendment 1.

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

The noble Lord, Lord Sharkey, made his points cogently on Report. We do not intend to oppose the amendments on the Marshalled List, as they are technical tidying amendments, consequential on those in the name of the noble Lord, Lord Sharkey, that were passed on Report.

[Lord Sharkey (LD) [V]]

I am very grateful to the Minister.

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Moved by

[Lord Bethell]

That the Bill do now pass.

[Lord Bethell (Con)]

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

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

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

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

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

[Baroness Thornton (Lab) [V]]

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

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

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

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

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

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

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

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[Lord O’Shaughnessy (Con) [V]]

My Lords, there is not much more to say that has not already been said by other noble Lords. I just wanted to use this opportunity to thank and pay tribute to particular groups. The Bill team and private office, which have worked so hard to produce this legislation, are amazing in what they do and often unsung. It is important we recognise them.

Secondly, I thank those patients and patient groups who have provided so much moving information and testimony that has informed our work. After all, we serve them, and I hope and believe that we have served them through improving this Bill in this House in the way we have.

Thirdly, I pay particular tribute to my noble friend Lady Cumberlege. When I was in government and we commissioned her report, I could not have dreamed that she would have done such a thorough job and carried it with her customary tenacity, to the point where we have, on statute, the commitment to a patient safety commissioner. It is such an important step forward and it will make a massive difference to the lives of hundreds of thousands of people in this country. For that, we should all be proud of this step—and she in particular should be.

Finally, I thank the Minister—my noble friend Lord Bethell—the noble Baroness, Lady Penn, and the noble Earl, Lord Howe, but particularly the Minister; he has performed with absolute aplomb in the difficult 10 months since he became a Minister. He has so much on his plate, yet throughout this process he has listened, engaged and acted in a way that does him enormous credit, and I really want to pay tribute to him for everything he has done.

I share the Minister’s optimism that, having produced this Bill, we can produce a regulatory system for the UK outside Europe that is the envy of the world, that makes sure that every company, every charity and every researcher who wants to bring a transformative therapy into a health system will come to us because of what we are able to do and how we are able to bring them through into mainstream treatment, just as we are doing with vaccines and have done with the recovery trial. That is the template, and I look forward to working with my noble friends and other noble Lords to make that happen in the months to come.

[Lord Bethell (Con)]

My Lords, I am extremely touched by the kind words of noble Lords and pay tribute once again to the hard work of all those concerned. I look forward to the future—to, as my noble friend Lord O’Shaughnessy said, the opportunity for patient safety and innovation to be enhanced by this Bill. In that spirit, I beg to move.

Bill passed and returned to the Commons with amendments.

Covid-19: Vaccination

Lord Bethell Excerpts

Wednesday 20th January 2021 Lords Chamber

[Lord Cormack]

To ask Her Majesty’s Government what plans they have in place to ensure that no one has to wait more than three months for a second dose of a COVID-19 vaccination.

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

My Lords, we are absolutely committed to making sure that everyone gets two doses, so if they have received their Pfizer first dose, they will get a Pfizer second dose within 12 weeks of the first one. Similarly, if they have had their AstraZeneca first dose, they will get their AstraZeneca second dose within 12 weeks. The four UK CMOs and the JCVI agree that prioritising the first vaccine dose will protect the greatest number of at-risk people overall in the shortest period of time.

[Lord Cormack (Con) [V]]

My Lords, naturally I thank my noble friend for that Answer. I have just returned from the very efficiently run county showground vaccination centre outside Lincoln, where I have had my first dose and have been given a date for my second. My noble friend has certainly reassured me on the Government’s determination both to give the same vaccine and at the right time. However, is he aware of the findings in Israel, where there has been an extremely impressive rollout of vaccination, which have cast considerable doubt on the wisdom of delaying the second dose? This has caused a great deal of concern, not least in your Lordships’ House, voiced by the noble Baronesses, Lady Boothroyd and Lady Bakewell, among others. Can he please give us some reassurance that there is no danger of diminishing the efficacy of the vaccine by delaying the second dose?

[Lord Bethell (Con)]

I am extremely pleased to hear the update from my noble friend, and I thank all those in Lincoln who were contributing to his effective vaccination and his second appointment, which is very reassuring. I reassure him that, on the Israeli numbers, Sir Patrick Vallance, the Chief Scientific Adviser, has been very clear—he was on the media round this morning. The Israelis looked at a very specific time period—14 days—and a very specific age group. This is very different to the analysis done by the JCVI and the MHRA, which looked at all age groups over a much broader period. The efficacy of immunity from days 10 to 21 is thought to be 89%. That is a very considerable and impactful effect, and I have spoken to the noble Baroness, Lady Boothroyd, to reassure her on that matter.

[Lord Anderson of Swansea (Lab)]

My Lords, the rollout of the first vaccine has gone fairly smoothly, although there have been glitches or bumps, particularly in terms of regional disparities. What lessons have been learned, and what was the reason for choosing 12 weeks—was it administrative, medical or supply?

[Lord Bethell (Con)]

My Lords, there have been glitches; I do not know whether there are lessons learned. However, I can share with the noble Lord that the practicalities of getting the Pfizer vaccine in particular—which, as he knows, requires deep-cold storage—into every part of the country are quite challenging, and we are trying to reach not only the big mass centres but community pharmacies and GP surgeries. The delivery of the vaccine to thousands and thousands of locations will always be a little uneven, and there have been occasions where we have deemed it the correct procedure to have people stood up for their vaccination even though we were not 100% sure of the delivery of the vaccination. That does create concern but I think has been the right approach to take.

[Baroness Jolly (LD) [V]]

My Lords, my question follows that of the noble Lord, Lord Anderson of Swansea. For many in isolation, the appointment for their first jab is all that has kept them going, and the certainty of timing of the second has changed since the introduction of the vaccine regime. Can the Minister tell us whether that is to do with the region—there seem to be problems in the south-west—or is it demand, logistics or science?

[Lord Bethell (Con)]

My Lords, if I understood the noble Baroness’s question correctly, I reassure her that absolutely everyone’s details are registered in the national immunisation database, so everyone will receive an invitation for their second dose, as I mentioned earlier. However, the reason for having this longer period before the second dose is completely pragmatic. Every 250 doses saves a life, so it is absolutely essential that we get the maximum number of first doses out as quickly as possible. The MHRA, the JCVI and others have looked at the safety and efficacy of this approach, and they have found reassuring evidence that this will work extremely well. I take great joy in the fact that we have found a way to get the highest number of doses to the greatest number of people as quickly as we possibly can.

[Lord Ribeiro (Con) [V]]

My Lords, mindful of the impact of Covid-19 on front-line health staff during this pandemic, and given the report in the Times today of reduced supplies of the Pfizer/BioNTech vaccine during January and February, can the Minister say what plans there are to ensure that these front-facing health staff in hospitals and care homes are prioritised as a matter of urgency to protect them from the pandemic? As someone in his late 70s who is waiting for the vaccine, I am happy to forgo mine until such time as the health staff I mentioned are protected.

[Lord Bethell (Con)]

I am enormously grateful for my noble friend’s important gesture and pay tribute to his generosity of spirit. However, it is absolutely essential that he gets his vaccine as soon as he can, because he is at the top of the list. Morbidity is determined by age, not proximity. Healthcare staff are of course of deep concern to all of us, but those who are in PPE and in protected conditions have no greater chance of getting the disease than members of the general public. It is essential that we put those who have the highest risk of morbidity—the oldest—at the front of the queue, which is why we have the prioritisation list that we have.

[Baroness Campbell of Surbiton (CB) [V]]

My Lords, I thank the hard-working Minister and his Government for listening to the most clinically vulnerable groups and for reprioritising vaccination for all care workers, ensuring their greater safety. However, I am concerned that people under 65 with learning disabilities who live in care homes are in group 6 rather than in group 1, when ONS data clearly shows that they have been disproportionately affected throughout the pandemic. It is illogical that they now have to wait longer than other people with learning disabilities—older ones—in residential care. What plans do the Government have to ensure consistency and fairness in vaccination allocation to all people in residential care, especially in this category of people?

[Lord Bethell (Con)]

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

[Baroness Thornton (Lab) [V]]

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

[Lord Bethell (Con)]

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

[Baroness Sheehan (LD) [V]]

My Lords, can the Minister say how concerned the Government are that diminishing efficacy in partially immunised people among a population with high prevalence of the disease, as we have in the UK, will foster ideal conditions for the virus to mutate into vaccine-resistant forms?

[Lord Bethell (Con)]

My Lords, I do not quite agree with the premise of the question, which is the concept of being partially vaccinated. When you get your first vaccination shot, you are vaccinated, your body has been primed, B cells make the antibodies and you learn how to fight the disease. That is categoric. Where the noble Baroness absolutely has a point is that it is an uncomfortable truth that when we lean in to the virus, it will seek to escape and mutate, and that is the moment of absolute highest risk for the country. That is why we are trying to move as quickly as we humanly and possibly can: there is a moment in time, an opportunity to get the vaccine out to as many people as possible to avoid the mutation throwing up variants that escape our vaccine.

[Lord Mann (Non-Afl)]

We heard a few voices last spring and summer suggesting that the National Health Service was not good enough and that a privatised service would have been better in dealing with the pandemic. They are remarkably silent now. Will the Minister join me in the celebrations across this country at the moment of the brilliance of the National Health Service and the fact that people being vaccinated are going in with a smile on their face, being welcomed by people—volunteers and staff—with a smile on their face, all saying how brilliant our National Health Service is?

[Lord Bethell (Con)]

My Lords, I am enormously grateful for the testimony of the noble Lord, but I would probably put it slightly differently. Listen, we are in Act I, and I do not think it is quite the right moment to take curtain calls and bows just yet. The NHS has stepped up to this challenge absolutely magnificently, but there is still a huge amount to do and to get through. In addition to the praise that the noble Lord rightly gave the NHS, I also pay tribute to other parts of government, and particularly to the Army, local authorities and the private sector, which contributed the vaccine in the first place, all of which have worked together in a great spirit of collaboration. It is only through that spirit of collaboration that we have been able to deliver what we have.

[The Lord Speaker (Lord Fowler)]

My Lords, the time allowed for this Question has elapsed, and we now go back to the third Oral Question.

Health: Brain Tumours

Lord Bethell Excerpts

Tuesday 19th January 2021 Lords Chamber

[Lord Hunt of Kings Heath]

To ask Her Majesty’s Government what steps they are taking to encourage research into (1) the causes, and (2) the treatment, of brain tumours.

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

My Lords, I am hugely grateful to noble Lords for bringing this challenge to my attention. It is House of Lords advocacy at its best. We have met interested parties and I am pleased to say that we have a plan. Workshops are being booked, more research is being funded and we are encouraging more researchers to become involved. I am hopeful that this will mean progress and I am watchful to ensure that it delivers.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I am very grateful to the Minister for that positive response. Can he assure me that, in addition to seeking ways of being able to spend up to the £40 million research money made available, he will comment on the report of the chair of the all-party group on brain tumours, which says that there is greater need because there are no researchers able to undertake much of this research? Can he consider steps to address this imbalance and attract the brightest of medical and scientific minds into this uniquely complex area?

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[Lord Bethell (Con)]

The noble Lord is right: it is extremely complex and one of the challenges we have is that the basic science needed to guide research is an unpredictable and difficult-to-manage process. That is why I have invited representatives of patient groups to try to guide the basic scientific research so that the talented cancer researchers who are available, who can do the more operational and applicable elements of the research, will have the material necessary to get on with their job.

[Lord Taylor of Warwick (Non-Afl) [V]]

My Lords, it is arguable that, of all the human organs, the brain is the main. People from the black community are nearly three times more likely to develop pituitary tumours at the base of the brain than their white counterparts. The reasons for this disparity are still not clear. Will the Government commit to encouraging further research into this issue? Also, only 14% of UK spending on brain tumour research is from the Government; the remaining 86% is from the charity sector. Although more money is not the total answer, will the Government commit to more funding for this vital area of research?

[Lord Bethell (Con)]

My Lords, £40 million was announced in May 2018 for brain tumour research. To date, £9.3 million has been committed and £5.5 million will be committed from April 2018 to 2023. At this stage, as the noble Lord, Lord Hunt, alluded to, the allocation of budget is not the issue. Making sure that the pipeline of applicable research is in place is our challenge. That is why we have worked well with interested parties to put together a plan for trying to ginger along the basic science necessary to get those research projects activated.

[Lord Sharpe of Epsom (Con)]

My Lords, in 2019, my 22-year-old son, Charlie, was diagnosed with a germinoma, which is a rare form of brain tumour. He was referred for proton-beam therapy at the Christie Hospital in Manchester by the excellent Dr Jeremy Rees of the National Hospital in Queen Square. First, I thank the Government for spending the vast amount of money required to establish this capability in the UK, which, I am pleased to say, I think has been successful. Is the second facility at UCLH still on track to come on stream in 2021? Perhaps the Minister might reflect on the clinical expertise that has developed over the last year since the establishment of the facility at the Christie Hospital.

[Lord Bethell (Con)]

My Lords, it is fantastic news that my noble friend’s son has benefited so well from our considerable investment in proton-beam therapy. I wish both him and his son good luck on behalf of all noble Lords. I am not aware of any current plans to open a PBT site in Birmingham, but I can reassure him that the UCLH site in London is due to open this year and we look forward to that very much indeed. It was hoping to open in 2020 but plans were impacted by the pandemic. As with any ground-breaking technology, clinical expertise in PBT will continue to increase as our hard-working frontline radiological staff treat more and more patients.

[Lord Patel (CB) [V]]

My Lords, I am most encouraged by the opening statement from the Minister and the Answer he gave to the noble Lord, Lord Hunt of Kings Heath. That goes a long way to answering my question, which was whether he agrees that to improve the outcome for patients with brain tumours, we need a strategy that addresses the clinical and research workforce; basic and clinical research, including genetics; research funding; and diagnostic and treatment centres of excellence—a strategy similar to one that dramatically improved outcomes for patients with breast cancer and leukaemia. Does the Minister agree that the director of the National Institute for Health Research—or anyone else that he feels appropriate—should be asked to develop such a plan?

[Lord Bethell (Con)]

My Lords, the noble Lord makes an excellent suggestion. Indeed, I am pleased to report that exactly such a strategy is in place by working with the Tessa Jowell Brain Cancer Mission, to which the department, the NIHR, NHS England and NHS Improvement are all active contributors. As part of the mission the department is funding new research through NIHR, encouraging new researchers to become involved, and we will be supporting the delivery of research as a key part of the new Tessa Jowell centres of excellence.

[Baroness Pitkeathley (Lab) [V]]

My Lords, many experts conclude that without new discoveries the outlook for patients with brain tumours is bleak. Given that many sufferers are in their teens or twenties and reliant on the support of their parents or carers, do the Government see it as a priority to support families, both during treatment processes and during the all-too-frequent bereavements?

[Lord Bethell (Con)]

My Lords, the noble Baroness is right that brain tumours and brain cancer are some of the most awful situations, particularly because they so frequently affect the young. That is why infrastructure spend on brain tumour research has increased. I am pleased to say that we received 62 applications for research funding between May 2018 and 2020, 10 of which have been funded so far, but more can be done in that area. Supporting families is, of course, part of the responsibility of the charities and trusts involved, and I wish the best to all those families who have been hit by this awful condition.

[Baroness Jolly (LD) [V]]

My Lords, when this issue was raised at Questions on 19 November last year, the Minister suggested that the quality of applications needed improving. He kindly offered to meet research charities working in this area to facilitate this. Can he tell the House which of these charities he has met or has an appointment to meet and how many applications have since been received?

[Lord Bethell (Con)]

My Lords, I have had three meetings, particularly with the Tessa Jowell Brain Cancer Mission, which has been extremely constructive and brought with it clinical expertise, patient groups and policymakers. Together we have worked on a plan, which I articulated in my opening remarks. It has emerged that it is not a question of the quality of the research applications. The quality of research in this area is fantastic. The problem is that we need to have better basic science at the very early stage of the pipeline in order to guide the later operable research suggestions. That is why we have organised the workshops, are feeding back to the applicants in the previous round of research and are actively engaged in this area.

[Lord O'Shaughnessy (Con) [V]]

My Lords, I declare my interest as a patron of the Tessa Jowell Brain Cancer Mission. I thank my noble friend for his sincere engagement with the challenge of improving the quality of brain cancer research since my Oral Question last year. He has taken the bull by the horns and I think we have a plan that is going to make a difference. I wonder if he might also comment on the difficulties that medical charities, which are such an important part of the funding landscape, are having at the moment because of the Covid crisis. This particularly affects hard-to-treat cancers such as brain tumours. Are the Government willing to give more support to these charities to ride out the difficult times they face at the moment?

[Lord Bethell (Con)]

My noble friend alludes to a situation that is grave and concerning. Hundreds of millions of pounds have disappeared from medical research charity income, particularly through the closure of second-hand clothes shops, which provide an enormous amount of income for British medical research. I pay tribute to the massive contribution of medical research charities in trying to move forward the science of medical research. This is an area we are deeply concerned about, and colleagues at BEIS and the Treasury are actively engaged with it. My noble friend is right that this a knotty situation to solve that we need to look at very carefully indeed.

[Baroness Wheeler (Lab) [V]]

My Lords, I was very privileged to be present in the Chamber when my noble friend Lady Jowell made her plea to improve brain tumour treatment, research and survival. The work since her death of the Tessa Jowell Brain Cancer Mission, referred to by the Minister and other noble Lords, on the new national strategy has been inspirational. The mission has developed clear practical steps and pathways to build the quality, quantity and diversity of research that the UK needs, such as addressing delays in opening clinical studies, programmes to train the UK’s first generation of brain tumour-specific positions, and dedicated brain tumour centres. What steps are the Government taking to make sure that the NIHR, the MRC and the UKRI work together to ensure that the progress we need comes about? What will happen to the NIHR funding money put aside for brain tumour research in 2018 that remains unallocated at the end of the five-year window announced three years ago?

[Lord Bethell (Con)]

My Lords, I also pay tribute to the Tessa Jowell Brain Cancer Mission and all its work in putting together a really thoughtful strategy for tackling this most difficult issue. NIHR cancer research expenditure has risen from £101 million in 2010 to £138 million in 2019-20, and its settlement in the recent spending review was generous. I am optimistic that there are more resources there. I reassure the noble Baroness that, although the £40 million for brain tumour research has not all been allocated yet, it is not going anywhere and we are working as hard as possible to ensure that the right kinds of research project are put forward for that money. I would like to see it allocated as soon as possible.

[The Deputy Speaker (Baroness Garden of Frognal) (LD)]

My Lords, the time allowed for this Question has now elapsed. I apologise to the noble Lords, Lord Carlile of Berriew, Lord Polak and Lord Jones of Cheltenham, that we did not have time for their questions.

Health: Eating Disorders

Lord Bethell Excerpts

Tuesday 19th January 2021 Lords Chamber

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

My Lords, eating disorders are serious, life-threatening conditions, and we are committed to ensuring that people have access to the right support when they need it. We are growing our investment in community healthcare for adults year on year—almost £1 billion extra by 2023—with specific funding to transform adult eating disorder care and, for young people aged 16 to 25, to accelerate provision beyond existing growth and to transform plans.

[Baroness Parminter (LD) [V]]

The NHS health survey suggests that the prevalence of eating disorders is significantly higher than previously assumed, so will the Government commission a national, population-based study to accurately identify the number of people with eating disorders, as the Public Administration and Constitutional Affairs Committee recommended, to inform research and service-level provision?

[Lord Bethell (Con)]

My Lords, the noble Baroness is right: the statistics on eating disorders are shocking. The Mental Health of Children and Young People in England Survey identified 0.4% of 5 to 19-year-olds and 1.6% of girls aged 17 to 19. The NHS Digital Adult Psychiatric Morbidity Survey showed 6.4% of adults displaying signs of an eating disorder. There is the survey by Beat, and I could go on. I do not think it is an issue of surveys; we have to address the underlying statistics with measures that make a difference.

[Lord Winston (Lab) [V]]

It is very helpful that the Minister recognises the seriousness of anorexia nervosa and other conditions. It remains puzzling, and the causes are not fully understood, but the long-term risks—for example, infertility or the loss of a child during pregnancy or childbirth—are very serious. Given that some of these patients require almost forced admission to hospital, is there any scope for reviewing this issue when we come to consider the mental health provisions that are due next year?

[Lord Bethell (Con)]

The noble Lord puts it extremely well. Instances of those in pregnancy who have eating disorders are particularly heartrending and disturbing. He is right: sometimes, the condition is so extreme that it needs virtual full admission. We have put six new beds in the south-east, five in the Midlands, five in the east of England and 10 in the north-east. We are putting a massive amount into mental health budgets and this provision covers exactly this kind of disorder because we recognise that more resources are needed. I look forward to further announcements of spending in this area.

[Lord Truscott (Ind Lab) [V]]

My Lords, as the Minister said, the statistics outlined by the health survey are of obvious concern, but the survey, published last December, does not cover the period of the Covid pandemic. Has the Minister any evidence that eating disorders have increased during the pandemic? If so, what is Her Majesty’s Government’s response?

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[Lord Bethell (Con)]

The noble Lord is right: the pandemic will have added pressure, particularly on young girls. In-patient units are experiencing tremendous pressure, so it is difficult to see those instances working their way through primary care at the moment. We are studying the situation very carefully, but the noble Lord is entirely right: it is quite possible that incidents will increase, and we will put resources in place to address that.

[Lord Lingfield (Con)]

My Lords, is my noble friend aware that around a quarter of all sufferers of eating disorders are men, and that the number of males seeking help has gone up by 70% in the last decade? With the increasing emphasis on young men to attain a certain body type, does he agree that more males might need support in the coming years?

[Lord Bethell (Con)]

My noble friend is right to remind us that this is not a gender-specific condition and that many men have eating disorders of one kind or another. The culture we live in does nothing but encourage that and I think we have to address the underlying causes, both psychiatric and the pressure of social media. We will be putting in place the resources necessary to support that kind of initiative.

[Baroness Tyler of Enfield (LD) [V]]

My Lords, NHS Digital has reported that admissions for eating disorders have almost trebled since 2007, but there has been very little investment into in-patient treatments since then. With only 400 NHS beds for adult eating disorder sufferers in England, and capacity currently further reduced by the pandemic, what are the Government doing about this chronic shortage of in-patient beds for those suffering from serious eating disorders, which particularly affect young women?

[Lord Bethell (Con)]

The noble Baroness may not have heard my answer to the previous question, where I cited the large number of beds opened in the last year, totalling more than 30 across the country. I recognise that more beds are needed for those who have particularly acute disease, but the large prevalence of the disease among hundreds of thousands of young girls and boys also means that community care has to be at the heart of our response to this condition.

[Baroness Fall (Con) [V]]

My Lords, this autumn, charities such as Place2Be have recorded a notable increase in issues of self-harm, suicidal thoughts and eating disorders. The impact of shutting schools has been huge, and we will not know the legacy of that for a long time to come. I am reassured to hear the Minister say that he is as concerned as I am to look at ways to deal with this, but will he and others consider making school teachers the first priority for receiving the vaccine, after the most vulnerable and aged in our population, so that schools can open as soon as possible?

[Lord Bethell (Con)]

My Lords, we recognise the contribution of charities to this mental health challenge, and £10.2 million of additional funding has been allocated to mental health charities. We also recognise the importance of keeping schools open: no Government could have tried harder to keep schools open than this one. However, the allocation of the vaccine is based on morbidity—we have to protect those whose lives are most threatened and that is why the JCVI has put the prioritisation list in the form it has.

[Baroness Bull (CB)]

My Lords, a recent literature review found that many GPs feel unequipped to identify and manage eating disorders, meaning that patients who could benefit from primary care are often passed on to specialist services and face long waiting lists. Given the importance of early intervention, can the Minister say what is being done to train and support primary care professionals in diagnosing and treating people with eating disorders, and to improve shared care across the primary and secondary care interface?

[Lord Bethell (Con)]

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

[Baroness Thornton (Lab) [V]]

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

[Lord Bethell (Con)]

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

[Baroness Walmsley (LD) [V]]

My Lords, the eating disorder faculty at the Royal College of Psychiatrists has recently reported that eating disorder teams are being asked to ignore the NICE guidelines for treatment as being unrealistic and too expensive. Will the Minister either justify this or condemn it?

[Lord Bethell (Con)]

The noble Baroness brings to my attention something concerning. I would be grateful if she would write to me with the details and will be very happy to look into it in more detail.

[Baroness Wheatcroft (CB) [V]]

My Lords, parents of adult children suffering from the most extreme eating disorders say they are often desperate to help but powerless because of an insistence on patient confidentiality. The desire to give autonomy to patients too often extends to those whose sickness with eating disorders makes them unable to take sensible decisions for themselves. Will the Minister agree to examine the conflict between these two wishes and how it could be resolved?

[Lord Bethell (Con)]

My Lords, the noble Baroness alludes to a conflict for which there is no easy answer. I completely sympathise with any parent whose child is exhibiting eating disorder issues. It is the most awful and frustrating situation for any parent to see their child in a self-destructive loop for which there seems to be no intervention possible, but patient safety is patient safety, and this is the conundrum that faces any mental health situation. The Mental Health Act is undergoing review at the moment—I am grateful to Sir Simon Wessely for his report, which we debated yesterday—and these are exactly the kinds of issues that we are looking at. I express profound sympathy for all those who find themselves in this awful situation.

[The Deputy Speaker (Baroness Garden of Frognal) (LD)]

My Lords, the time allowed for this Question has now elapsed. I apologise to the noble Lord, Lord McColl of Dulwich, that there was not time for his question.

Mental Health Act Reform

Lord Bethell Excerpts

Monday 18th January 2021 Lords Chamber

[Baroness Tyler of Enfield (LD) [V]]

My Lords, there is much to be welcomed in this White Paper, for which we have waited so long. I am pleased to see patient voices being put front and centre of plans and proposals to address the current shocking disparities in the rates of detention of people from black and minority-ethnic backgrounds. However, the issues that were highlighted in the Wessely review two years ago have continued to scar the lives of too many people during the extremely long gestation period of this White Paper.

The original legislation is 40 years old now and out of date. It is shocking, frankly, that it has taken us so long to amend archaic processes, such as an individual’s father automatically being their advocate in a mental health crisis, whatever the nature of the relationship or preference of the individual patient.

I understand the importance of getting the details right. However, I was concerned by the lack of urgency shown by the Secretary of State when responding to questions from MPs on the Statement last week. Why do we have to wait another year before the legislation can even begin? Can the Minister give us a concrete timeframe for the further consultation? What is the timetable for taking forward the non-legislative reforms in the Wessely review, not least to achieve wholesale cultural change in mental health services?

I am similarly very concerned about workforce issues facing this sector. Many of the workforce aims laid out in the NHS Long Term Plan are not on track to be met, with 12% vacancy levels in many mental health services. Between 2016 and 2019, demand for services increased by over 20%—and that takes no account of the exponential growth in mental health problems during the pandemic. Recent forecasts suggest, for example, that only 71 additional consultant psychiatrists will be added to the NHS workforce by 2023-24, against a requirement of more than 1,000 to deliver the long-term plan. What measures are the Government taking to address the additional workforce requirements of reforming the Mental Health Act?

We then come to the issue of funding. The short-term injection of £500 million is, of course, welcome, but it is sustainable and long-term investment in services—covering the full spectrum from preventive to crisis care—that we so badly need. We need a comprehensive plan for funding all existing and new mental health services, rather than one-off injections of short-term funding. Above all, this means investment in community services. In a survey of Royal College of Psychiatrists members, insufficient access to community health services was cited as the greatest cause of increases in formal admissions. The best way to prevent people being detained under the Mental Health Act is to prevent them reaching crisis point in the first place.

Like the noble Baroness, Lady Thornton, I am deeply worried about the impact of the pandemic on the nation’s mental health. In October last year, the Centre for Mental Health estimated approximately 10 million extra people with mental health needs due to the pandemic—a staggering figure. While it is understandable that we have been focusing on the physical threat of the pandemic and protecting our acute services, when will the Government come forward with proposals to address what some are now calling a mental health emergency?

It is an unpalatable fact that black people are currently 10 times more likely to be placed on a community treatment order. In these situations, patient voices become even more important, ensuring that culturally appropriate services can be provided. The patient and carer race equality framework is a good start; I look forward to hearing more on this issue. I note that cultural advocates are currently being recruited, but can the Minister confirm how many patient and carer advocates will be involved in both the advancing mental health equalities task force and the patient and carer race equality framework steering group? Also, why are the Government not proposing to legislate for a CTO to have a maximum duration of two years or to allow tribunals to change the conditions imposed on an individual by the order, as recommended by the Wessely review?

I end by returning to the issue of prevention. The courses of action covered by this legislation represent the worst-case scenarios for individuals experiencing severe mental health problems. We have so much evidence telling us that investments in preventive measures are highly cost-effective interventions and avoid the trauma of crisis scenarios for patients. While we debate this White Paper, it is vital that we do not lose sight of the bigger picture.

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

My Lords, I thank both noble Baronesses for their incredibly perceptive, thoughtful and detailed questions, some of which I am afraid are beyond the brief in front of me. I reassure them, particularly the noble Baroness, Lady Tyler, that I will write with detailed answers to some of their more perceptive and searching questions.

We are all enormously grateful to Sir Simon Wessely for his thoughtful, persuasive and thorough report. It has taken some time to work on it, but now that it has arrived we will act on it. I reassure the House that it is an enormous priority.

I reassure both noble Baronesses that funding is absolutely in place for mental health. If I may briefly run through that, an extra £2.3 billion a year for mental health services is committed by 2023-24. Some £500 million in mental health investment in the NHS workforce was announced in the spending review, and it will go towards addressing waiting times for mental health services.

The noble Baroness, Lady Tyler, referred to the challenge of recruiting psychiatrists. As she knows, that area is extremely challenging. The employment brand of mental health services is not as strong as it is for, say, surgeons, but we have done an enormous amount through HR and the people plan to find new ways of attracting people to rewarding and challenging roles in psychiatry, and those investments are beginning to pay off.

We have invested more than £10 million this year in supporting national and local mental health charities to continue their vital work in supporting people across the country. I will move on to the mental health effects of the pandemic in a second. We have invested £8 million in the Wellbeing for Education Return programme, which will provide schools and colleges all over England with the knowledge and resources to support children and young people, teachers and parents. We have announced more than £400 million over the next four years to refurbish mental health facilities to get rid of dormitories in such facilities across 40 trusts.

The noble Baroness, Lady Tyler, asked me about urgency and whether the Government were truly committed to moving quickly. I reassure her that money has already been announced and plans are in place to address some of Sir Simon’s most urgent recommendations.

Both noble Baronesses asked about the timetable for legislation. I reassure them that the consultation began last Wednesday; it is a 14-week consultation and we have committed to responding to it this year. If I may advertise to noble Lords, this is a terrific opportunity for all those with views on mental health to contribute to that important engagement. It is our plan to publish the Bill next year on the back of that consultation and for legislative scrutiny to take place next year. The question of whether that will be joint legislative scrutiny is not clear to me right now, but I undertake to both noble Baronesses to inquire and press the case for joint scrutiny when I return to the department. I shall write to both of them accordingly.

The noble Baroness, Lady Thornton, raised the impact of the racial dimension highlighted in the report. The numbers in Sir Simon’s report are incredibly striking and it is crystal clear that this is an issue that we absolutely have to deal with. Will we go far enough? Yes, indeed we will. The framework recommended is extremely powerful and we are already putting it into place. We have learned an enormous amount from the report. The ability for those with mental health issues to nominate their own advocate is an extremely powerful innovation that I think will have a big impact on this issue, but we still have further to go. We are engaged with those who are both representative and expert in this area to ensure that we are challenged to go far enough.

Likewise, on learning difficulties and autism, noble Lords will remember that we have had powerful and moving debates in this Chamber in the last few months on that very issue. I reassure the noble Baroness, Lady Thornton, that we note Sir Simon’s recommendation in his report for a 28-day cap on the detention of those with learning difficulties and autism. It is just not good enough for those with learning difficulties and autism to be detained under a Mental Health Act restraint for an interminable period. That point is thoroughly recognised, and the report’s recommendations are extremely well made.

On the question of the pandemic, the noble Baroness, Lady Thornton, put it extremely well: there has been a shift in many people’s response to the pressures and the isolation of lockdown, from being stressed and anxious to having genuine clinical challenges. The full effects of that have not worked their way through the system so it is difficult to get a nuanced and complete view from the numbers today, but we are very much on the balls of our feet to understand and react to the pressures

If I may draw out one issue, young girls seem to be a demographic who have particularly felt the loneliness, anxiety and uncertainty around the pandemic and lockdown. We are particularly concerned to ensure that support goes to families and individuals who present clinical mental health issues as a result of the pandemic.

On the other, very detailed questions asked by the noble Baroness, Lady Tyler, I undertake to answer them in writing at the earliest possible opportunity.

[The Deputy Speaker (Lord Russell of Liverpool) (CB)]

We now come to the 20 minutes allocated to Back-Bench questions. I ask that questions and answers be brief so that I can call the maximum number of the 15 remaining speakers on the list.

[Baroness Hollins (CB) [V]]

My Lords, I welcome the focus of the consultation and the White Paper on prevention, along with the new duties on local commissioners to ensure that they understand and monitor the risk of crisis for individuals—for example, when a family member dies—and to ensure an adequate supply of community services for people with learning disabilities and autistic people as an alternative to admission. Does the Minister agree that for these duties to have teeth, the descriptor “adequate” will have to be defined and subject to legal enforcement?

[Lord Bethell (Con)]

The noble Baroness asks a very perceptive question. I pay tribute to her work in this area and the challenge and scrutiny that she has given to the Government, which have helped lead to the position we are in at the moment. This is exactly the kind of area that we will be presenting for consultation, and I very much look forward to the noble Baroness’s contribution to that consultation.

[Lord Holmes of Richmond (Con) [V]]

I welcome the White Paper, which represents a once-in-a-generation opportunity. Allied to that, can the Minister confirm whether the Government will commit to prioritising permanent and immediate mental health support for all our NHS front-line workers in ICU, in the emergency room and beyond—immediate lifelong prioritised mental health support for all those who have given so much support and continue to give it to all of us through this pandemic?

[Lord Bethell (Con)]

My Lords, I live opposite University College Hospital. Every night I hear the ambulances arriving and I think of the staff on the front line working so hard night after night in such difficult circumstances, dealing with people in agony. The mental health of our NHS staff is paramount. Some £50 million has been invested in strengthening mental health support for staff. We have put in place the mental health hotline, practical support, financial advice and specialist bereavement and psychological support. I have no doubt that more could be done but this is very much an area that, as my noble friend rightly points out, is worthy of more investment.

[The Lord Bishop of Bristol [V]]

My Lords, I join fellow Members in welcoming the Statement and the response to the significant report by Sir Simon Wessely. As the noble Baroness, Lady Thornton, noted and as the Minister commented, the evidence is that minority ethnic individuals are 40% more likely than white Britons to come into contact with mental health services through the criminal justice system. Will the Minister explain how the proposed framework will address the underlying attitudes and practices that led to this statistic, which at best are described as a failure to understand the culture and at worst are a reflection of racist views?

[Lord Bethell (Con)]

The right reverend Prelate is right to allude to the importance of culture. No amount of bureaucracy or guideline-writing can ultimately address the basic attitudes, backgrounds and mental starting point of those involved in these decisions. I reassure the House that at the moment we are processing the people plan, which addresses at a fundamental level the hierarchy, racism, homophobia and misogyny sometimes found in some parts of the NHS. We are acutely aware that culture is fundamental to the safe provision of services to patients. The framework itself is not wholly directed at culture, but it will be supplemented by these kinds of reforms.

[Lord Winston (Lab) [V]]

I congratulate the Government on getting Sir Simon Wessely to help them bring about this much-needed reform and will welcome seeing how it progresses in the next year. I want to draw attention to one of the problems about sectioning patients. Two members of my team at different times have been sectioned; both were psychotic and severely depressed at the time. One phoned me at 5 am to say that people had come for her; it was clear that this was highly scary and very damaging. The other patient was left in a police station after being found on a moor for many hours before eventually a bed could be found, miles from where she lived or where anybody could visit her. Also, the premises available for such patients when they have been sectioned seem quite inadequate. The Minister has mentioned the dormitory system, but when I visited both those women, I felt that I would be very depressed myself if I were in those circumstances. We need to do much more to make premises more homely if we are to be more successful in encouraging a return to normal health.

[Lord Bethell (Con)]

The noble Lord is entirely right: when people experience a mental health crisis, they should be treated with consideration. Unfortunately, the police are sometimes at the front line of dealing with those with mental health difficulties. It is a stretch for them, and they should have the right training to be able to deal with a situation sensitively and they should have the right premises to be able to give people safe and secure environments. It is at the outer limits of their professional responsibilities, but we are doing as much as we can to put the training in place.

I remember from my own personal experience, when my father and my mother were sectioned, the consideration and thoughtfulness of those involved in both those processes. It is not all bad, but I take the noble Lord’s point.

[Baroness Jolly (LD) [V]]

My Lords, I welcome the White Paper and the commitment to deliver person-centred care. Many health and social care professionals will need to change the way they work, which is both necessary and welcome. What is the national budget for training over the next five years and how soon will those being treated for mental health conditions expect to notice a difference in their care?

[Lord Bethell (Con)]

My Lords, the noble Baroness is entirely right: the training is critical in this area; it could not be more important. We have invested £500 million in mental health services and support for the NHS workforce to address this. I cannot give her the precise number that she has asked for, but I shall write to her if I can track it down. However, we recognise the urgency of the situation and we hope that the impact of this money will be felt as quickly as possible.

[Baroness Meacher (CB) [V]]

My Lords, I too welcome this White Paper based on the Wessely review. However, without real increases in spending on mental health, the anticipated Bill will not be able to fulfil its potential. I was not reassured by the Minister’s comments on funding.

If we become physically ill, we can expect to be treated within a reasonable timeframe; that is not so in mental health. If the Minister agrees that that is not acceptable, will he challenge the £2.3 billion figure, which, as I am sure he knows, will do nothing to rectify the ongoing imbalance and will leave people detained in hospital because of the absence of adequate community services?

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, the noble Baroness is right that community support for those with mental health challenges is critical—we are supporting community health in addition—but I slightly disagree that the £2.3 billion will make no difference. It is a phenomenal commitment and it demonstrates that the Government have recognised that mental health services have lagged behind primary care and physical services, as the noble Baroness rightly points out, and we are working hard to make up the difference.

[Baroness Sanderson of Welton (Con) [V]]

My Lords, I too welcome the White Paper and in particular one of its key aims, which is to address the disparities that exist in relation to those from black, Asian and minority-ethnic backgrounds. The data from the race disparity audit played an important role in revealing those disparities. Can my noble friend the Minister confirm that the Government will continue to utilise the work of the Race Disparity Unit as we continue on the path towards the first new mental health Bill in 30 years?

[Lord Bethell (Con)]

My Lords, I have met the Race Disparity Unit and can share my noble friend’s testimony to the critical work that it does. The statistical collections managed by NHS Digital have shone a light on the extent of the disparities illustrated by Sir Simon, most notably that black people are more than 10 times more likely to be made subject to a community treatment order after discharge from hospital. That is an astounding number. We are determined to take action; we will introduce a new patient and carer race equality framework which will support NHS mental health care providers to work with their local communities to improve the ways in which patients access and experience treatment. The Race Disparity Unit will continue to play a key role.

[Lord Bradley (Lab) [V]]

My Lords, while I welcome the White Paper, it is unlikely that the legislation will be enacted until 2023. Many reforms can be made before that date to implement some of Sir Simon’s recommendations, including the development of community facilities to support people with learning disabilities and autism so as to hugely reduce the use of in-patient beds and, crucially, alternative provision to finally stop the use of prison and police custody suites as places of safety. I therefore press the Minister again to assure the House that sufficient capital funds are available within the NHS long-term plan to implement such key recommendations.

[Lord Bethell (Con)]

The noble Lord is 100% right: we can definitely start work on the recommendations of the report. As I said earlier, we have already done so: committing £400 million to end dormitories in 40 trusts. That sort of parallel processing can be done for other elements of the report. The consultation began last week, which shows our determination to get moving. Some recommendations of the report are spellbindingly obvious; we will work on them immediately. The role of police suites in safe refuge, cited by the noble Lord and by the noble Lord, Lord Winston, is exactly such an example.

[Baroness Barker (LD) [V]]

My Lords, this is yet another NHS document which makes not a single mention of the needs of LGBT people. The Statement is in effect an admission that the Mental Health Act 2007 was deeply flawed and, as a result, thousands of people have been subject to wrongful treatment. Will the Government act now to stop the abuse of community treatment orders and other elements of that Act that have led to the position that is so accurately described by Sir Simon Wessely?

[Lord Bethell (Con)]

My Lords, I confess that the noble Baroness has me on the hop there, because I had not noticed that LGBT issues are not mentioned in Sir Simon’s report. I share the noble Baroness’s surprise about that. Let me return to the document and I will address her point in correspondence.

[Baroness Wheatcroft (CB) [V]]

My Lords, Sir Simon found excessive use of restrictive practices in mental health institutions. Many of us will be familiar with the appalling case of Bethany, the autistic teenager who spent three years in what can be described only as a cell, in an appallingly inhumane regime that kept her locked up in solitary confinement and with no physical contact with other people. Only when her father went to court did she escape, and she is now living happily in an open-plan institution. Can the Minister assure us that such treatment will never be condoned again? We cannot wait for legislation on this.

[Lord Bethell (Con)]

My Lords, I certainly do not condone that treatment in any circumstances, but I acknowledge the noble Baroness’s point: there have been some instances in the past—reasonably rare but consistent—where those with autism and learning difficulties have been subject to the most inappropriate regimes and where a completely different type of support, therapy and accommodation from the kind found in mental health institutions was needed. The campaign to which the noble Baroness alluded is entirely right and we are moving quickly to address those points.

[Lord Davies of Brixton (Lab) [V]]

My Lords, the White Paper is certainly to be welcomed, as there is much to be done. The number of people being detained in hospital under the current Mental Health Act has increased over the past few years. One reason is the lack of resources to provide the support needed in the community and respite care. While we are told that there has been investment, the resources often do not reach hard-pressed mental health trusts. More resources will be needed, not only to grow the workforce but for the workforce to receive education and training in the values and practices needed to deliver the radical changes envisaged in this review. We should also ensure that the workforce better reflects the communities it serves. Again, while I welcome the promise of further investment in mental health services, will the Minister give a commitment that this will be new money and that it will reach mental health trusts, to provide the workforce growth, and Health Education England, to provide the workforce training essential for delivering the aims of the White Paper?

[Lord Bethell (Con)]

The noble Lord is right; the numbers are inappropriate. Fifty-one thousand detentions under the Act in 2019-20 seems far too many. Detentions under the Act rose by 40% in the 10 years to 2015, and we thought of this Act to try to address that injustice. The £2.3 billion is new money, and it will make a huge impact on the mental health trusts he describes.

[Baroness Sheehan (LD) [V]]

My Lords, sadly, I have personal experience of having to invoke the Mental Health Act. It is a dreadful process. It concerns me that one of the reforms proposed is to tighten the criteria for civil patients’ detention by raising the threshold for risk of harm. Does the Minister agree that this reform risks increasing harm to the person who is ill and their family?

[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?

[Lord Bethell (Con)]

My Lords, the role of health review tribunals is critical, and more needs to be done to ensure that they reflect the communities they represent. I am not sure it is the role of mental health trusts to finance local advocacy groups, but he is right that they make a difference and hold the system to account. The broader issue of racism in the NHS is a cross-institutional challenge that must be addressed by all parts of the NHS, and we are committed to doing so.

[Lord Dodds of Duncairn (DUP) [V]]

My Lords, I warmly welcome the Government’s proposals. A key area of concern for me is the length of time people spend waiting in emergency departments for assessment, even after being referred by their GPs. Will the Government guarantee, as others have mentioned, that sufficient resources in staffing will be made available to ensure that these warmly welcomed reforms are carried out and the quality of care increases?

[Lord Bethell (Con)]

My Lords, I can reassure the noble Lord only by saying we have put an ambitious report on the table. We will follow it up with a detailed consultation process that will engage Parliament in due course and lead to an ambitious Bill. That will be backed by substantial financial investment; thereby, we hope to make a major impact on the issues he describes, which I recognise and acknowledge.

[Lord Adonis (Lab)]

My Lords, Sir Simon’s report makes no reference to international best practice and gives no internationally comparative statistics—for example, on sectioning. I gave the noble Lord notice of a question I would like to ask about what international best practice the Government have in mind. Will he be able to make available to me, perhaps in correspondence, internationally comparative, population-adjusted statistics for sectioning? This will be important for putting the reforms he suggested in context before we proceed to legislation.

[Lord Bethell (Con)]

I am enormously grateful to the noble Lord for sending me his question, but I am embarrassed to say that I did not receive the correspondence. I would love to have the figures to hand, but I will write to him with details. If I could gently push back: this is not an easy issue to make international comparisons on, and we are not necessarily led by what other countries do in this area. We have to own this problem ourselves and find an approach that fits the NHS and people in Britain, and we have to be accountable to the people of Britain for our performance.

Medicines and Medical Devices Bill

Lord Bethell Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

When I was doing my research, I was astounded by the volume of anti-vax propaganda undermining public trust. Social media of course carries a large amount of the extreme views. While not the majority, the minority is not insignificant, and with the Government putting their efforts into the rollout of the vaccine as their strategy for exiting the crisis, strong action is needed to counter the threat of anti-vax disinformation. The Government were quick to adopt our mobile phones as a tool to fight the virus. Are they as willing to counter this misinformation via those phones that have the Covid-19 app installed? In summing up, will the Minister tell us whether there is a plan to do this?

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

My Lords, what a helpful and instructive debate, and I thank all noble Lords who were involved.

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

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

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

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

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

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

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

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

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

[Baroness Thornton (Lab) [V]]

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

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

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Moved by

[Lord Bethell]

17: Clause 7, page 4, line 36, after “a” insert “relevant”
Member’s explanatory statement
This amendment and the amendment in the Minister’s name to add a definition of “relevant person” to Clause 7 restrict the persons to whom information may be disclosed in reliance on Clause 7(2).

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[Lord Bethell (Con)]

My Lords, in moving Amendment 17 I will speak also to Amendments 19, 22, 23, 25, 35, 37, 38, 55, 56 and 58 to 62. All amendments in the group deal with the sharing of information outside the UK where this is required to give effect to an international agreement or arrangement.

I have listened to the concerns raised by noble Lords as to further safeguards that could be provided in relation to Clauses 7, 12 and 37(5), and the amendments made in Grand Committee. I am enormously grateful to noble Lords who have met and spoken to me and my team over the weeks between Grand Committee and Christmas. Their further explanations and collaborative spirit have been enormously valuable. I can say confidently that this collaboration has definitely improved the drafting of the Bill.

It is worth saying first that the Bill introduces powers for international information sharing only where it is pursuant to international agreements or arrangements concerning the regulation of human medicines, medical devices or veterinary medicines. As such, we are starting from a place where it is in the public interest for data to be shared to support the safety of human medicines, medical devices and veterinary medicines in the UK and globally.

As I explained in earlier debates, information sharing with other regulators plays an absolutely critical role in the work of the MHRA and the VMD to protect patient safety and to support international collaboration. For example, in medical device safety investigations, international information sharing allows for better signal detection and gathering of evidence to support the safety of medical devices available on the UK market. It is worth saying that failure to share that data has been one of the contributing factors to many patient safety issues. However, it is right that we ensure that when the MHRA and the VMD share information they do so with the appropriate persons. These amendments will ensure that.

Nevertheless, I have heard the concerns about the use of the term “persons” and whether this may be subject to broad interpretation. Noble Lords will agree that including in the Bill an exhaustive list of named organisations we share data with is not practical. Therefore, we have amended Clauses 7, 12 and 37 to include a definition of “relevant person”. These amendments clarify the types of persons outside the UK that information may be shared with. In short, they make it clear that these clauses do not offer a “blank cheque”.

We also heard concerns from noble Lords in Committee about the sharing of patient-identifiable information internationally. Clauses 7 and 37 already include safeguards to protect personal and commercially sensitive information, and there are additional safeguards in data protection legislation. However, we are keen to provide additional reassurance. That is why we have tabled further amendments that ensure that patient-identifiable information can be shared only if patients have provided consent.

In the vast majority of cases patient information is anonymised before being shared. These amendments account for the rare instances where it is necessary to share patient-identifiable data internationally to support our commitment to uphold patient safety; for example, in sharing patients’ concerns with an international regulator about a clinical trial they are taking part in in another country.

Finally, Amendments 22, 37 and 59 seek to clarify that the information-sharing powers in the Bill do not limit the circumstances in which information can be shared under any other enactment or rule of law. Such housekeeping amendments can be found as standard in many Acts and will ensure that the powers in the Bill cannot be construed as replacing existing statutory, prerogative or common laws of disclosure, which is not the intention. In introducing these amendments we seek simply to remove any potential confusion over what the powers in the Bill are intended to deliver.

I say again that I am enormously grateful to all noble Lords for their constructive challenge and thoughtful contributions on this subject. International information sharing is fundamental to the effective functioning of the MHRA and the VMD, but it is of vital importance that data is shared with care and that the appropriate safeguards are in place. I believe that our amendments deliver this balance. I beg to move.

[Lord Patel (CB) [V]]

My Lords, before I address the amendment from the noble Baroness, Lady Thornton, I reciprocate by thanking the Minister enormously for the many meetings he and his colleagues have had with all of us who are trying better to understand what the Government are trying to do with the Bill, particularly with these amendments. I agree that there are times, including in clinical trials—I have done this—when there is a need to share information with people involved in trials not only in the United Kingdom but overseas. I will come back to that in a minute.

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[Lord Bethell (Con)]

My Lords, we are enormously grateful to the noble Baroness, Lady Thornton, and the noble Lord, Lord Clement-Jones, for their Amendments 20 and 24 to one of my own amendments to Clause 7. These amendments seek to ensure that patient information can be shared by an appropriate authority only if the individual has given their explicit or informed consent, respectively. I completely recognise the commendable intent behind both amendments to safeguard and protect patient safety. Their intentions are benign but they are absolutely not necessary.

My lived experience for the past year has been completely aligned with the words of the noble Lords, Lord Clement-Jones and Lord Freyberg. Data is absolutely key. I have spent my time outside the Chamber working on little else: clearing the path for patient recruitment to clinical trials, so that therapies can be designed to save lives; getting data on long Covid patients from primary care to those researchers and clinicians who are trying to help them, which is an extremely complex and onerous task; getting central tracing data to local infections teams, which means transferring it between various jurisdictions; getting people to record the tests they take, which is a legal requirement but legally and technically difficult to implement; and getting test results from those who have taken them into their GP records. Most bizarrely, to me at least, I have been getting data-sharing agreements in place so that local authorities, which are crying out for the data—as their representatives here in this very Chamber cry out to me at the Dispatch Box for it—can access the dashboards with those legal agreements; or getting the data on those who may need support isolating into the hands of those charities and local authorities which are keen to support them.

Every step of the way, there has been an onerous set of legal, ethical and bureaucratic barriers. Speaking on the back of that experience, I wonder whether scientific deduction and patient safety are sometimes sidelined by other considerations. I therefore warn about measures that are driven by prejudice or secondary principles, rather than the priorities of trying to save lives and pursue science. Their unintended consequences can have a profound, stifling effect on patient safety, medical research and innovation, and on the effective running of a modern healthcare system. I can think of so many incidents where the need for data-sharing agreements, legally obtuse patient consents and all sorts of rarefied ethical reviews have caused major life-threatening obstacles and troubling issues in our response to Covid.

I know that the measures in these amendments are well intended, but I assure noble Lords that they are not necessary. For instance, Clause 7 accounts for the rare instances where it is necessary for the MHRA to share identifiable patient information internationally to support our commitment to upholding patient safety. I take this opportunity to assure noble Lords not only that this will be done only with the informed consent of the patient but that the practical implementation of some of the very measures in this Bill, such as the medical information system, will require these kinds of measures. It seems counterproductive for us to be undoing the benefits of our own information system.

Amendment 21 in the name of the noble Baroness, Lady Thornton, seeks to broaden the definition of patient information to include information that could enable identification. I reassure the noble Baroness that the MHRA absolutely follows the Information Commissioner’s gold standard practices on patient data anonymisation. In order to be truly anonymised under GDPR, sufficient personal data is always stripped out so that, not only can the individual not be identified, but reasonably available means could also not enable the recipient to re-identify the individual. As such, if patient information to be shared still enables the patient to be identified, for example due to the unique nature of their condition, the amendment in my name will provide sufficient protection by requiring that patient’s consent be sought before sharing their information. The MHRA keep anonymisation processes under review in line with the ICO’s guidelines and continue to monitor advances in data technology.

We have heard from the noble Baroness, Lady Thornton, and the noble Lords, Lord Patel and Lord Clement-Jones, on their Amendments 18, 36 and 57, which seek to limit the purpose for which information can be shared internationally under the powers. It is important to highlight that we could only disclose information under this power where disclosure is required in order to give effect to an international agreement or arrangement concerning the regulation of human medicines, medical devices or veterinary medicines. In that regard, the clause already allows disclosure only for a particular purpose. As international co-operation in this area is important and a good, even necessary, thing, such agreements or arrangements would be in the public interest by default. The UK meeting its international obligations under these agreements and arrangements would be even more so. Furthermore, the MHRA and VMD do not share information for commercial gain—on that point I want to be absolutely categoric. Therefore, I am persuaded that these amendments are accordingly unnecessary.

We have introduced a number of amendments to these powers to clarify the types of person with whom information can be shared and, for those instances when it is necessary to share identifiable patient data internationally, introduced a lock that ensures that data can be shared only with consent. These amendments are, of course, in addition to existing data protection legislation and ICO guidance. I can assure the noble Lords that we are not complacent when it comes to the safe and appropriate use of patient data. We understand that, as technology advances, we will need to continually review the way in which we anonymise data to ensure that it remains just that.

I hope this provides noble Lords with assurance that the Bill and the additional amendments in my name provide robust safeguards to protect patient information, alongside long-standing data protection legislation already in place, and that they will not press their amendments.

Amendment 17 agreed.

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Moved by

[Lord Bethell]

19: Clause 7, page 5, line 8, at end insert—
“(4A) Nothing in this section authorises a disclosure of patient information without the consent of the individual to whom that information relates.”Member’s explanatory statement
This amendment and the amendment in the Minister’s name to add a definition of “patient information” to Clause 7 prevent Clause 7 authorising the disclosure of information from which patients can be identified without their consent.

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Moved by

[Lord Bethell]

22: Clause 7, page 5, line 14, at end insert—
“(5A) This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”Member’s explanatory statement
This amendment provides that Clause 7 does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.

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Moved by

[Lord Bethell]

23: Clause 7, page 5, line 21, at end insert—
““patient information” means information (however recorded) which—(a) relates to—(i) the physical or mental health or condition of an individual, (ii) the diagnosis of an individual’s condition, or(iii) an individual’s care or treatment,or is (to any extent) derived directly or indirectly from information relating to any of those matters, and(b) identifies the individual or enables the individual to be identified (whether by itself or in combination with other information);”Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name adding a new subsection (4A) to Clause 7.

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Moved by

[Lord Bethell]

25: Clause 7, page 5, line 24, at end insert—
““relevant person” means—(a) the government of a country or territory outside the United Kingdom;(b) a person who exercises functions on behalf of such a government;(c) any other person who exercises functions or provides services relating to human medicines in a country or territory outside the United Kingdom;(d) an international organisation that exercises functions or provides services relating to human medicines.”Member’s explanatory statement
See the explanatory statement to the first amendment to Clause 7 in the Minister’s name.

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Moved by

[Lord Bethell]

29: Clause 9, page 6, line 22, leave out from beginning to “promote” on line 23 and insert “In making regulations under subsection (1), the appropriate authority’s overarching objective must be to”
Member’s explanatory statement
This amendment provides that the appropriate authority’s overarching objective in making regulations under Clause 9 must be to promote one or more of the following: the health and welfare of animals; the health and safety of the public; the protection of the environment.

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Moved by

[Lord Bethell]

33: Clause 9, page 6, line 33, at end insert—
“(3A) Where regulations under subsection (1) may have an impact on the safety of veterinary medicines, the appropriate authority may make the regulations only if the authority considers that the benefits of doing so outweigh the risks.”Member’s explanatory statement
This amendment provides that the appropriate authority may make regulations that may have an impact on the safety of veterinary medicines only if the authority considers that the benefits of doing so outweigh the risks.

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Moved by

[Lord Bethell]

35: Clause 12, page 8, line 19, after “a” insert “relevant”
Member’s explanatory statement
This amendment and the other amendment to clause 12 in the Minister’s name restrict the persons to whom information may be disclosed in reliance on Clause 12(2).

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Moved by

[Lord Bethell]

37: Clause 12, page 8, line 39, at end insert—
“(5A) This section does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.”Member’s explanatory statement
This amendment provides that Clause 12 does not limit the circumstances in which information may be disclosed under any other enactment or rule of law.

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Moved by

[Lord Bethell]

42: Clause 14, page 9, line 33, leave out subsection (2) and insert—
“(2) In making regulations under subsection (1), the Secretary of State’s overarching objective must be safeguarding public health.”Member’s explanatory statement
This amendment provides that the Secretary of State’s overarching objective in making regulations under Clause 14 must be safeguarding public health.

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Moved by

[Lord Bethell]

47: Clause 14, page 9, line 40, at end insert—
“(4) Where regulations under subsection (1) may have an impact on the safety of medical devices, the Secretary of State may make the regulations only if the Secretary of State considers that the benefits of doing so outweigh the risks.”Member’s explanatory statement
This amendment provides that the Secretary of State may make regulations that may have an impact on the safety of medical devices only if the Secretary of State considers that the benefits of doing so outweigh the risks.

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Moved by

[Lord Bethell]

50: After Clause 18, insert the following new Clause—
“Advisory committee
(1) The Secretary of State may by regulations establish, and make other provision about, a committee to advise the Secretary of State on such matters relating to medical devices as the regulations may specify.(2) The regulations may (among other things) make provision about—(a) the membership of the committee;(b) the establishment by the committee of sub-committees;(c) matters to which the committee may, or must, have regard;(d) cooperation between the committee and the Commission on Human Medicines, and other bodies with expertise in relation to medical devices.(3) The provision mentioned in subsection (2)(a) may include—(a) provision about the number of members, their appointment, and the circumstances in which a person ceases to be a member;(b) requirements as to the independence of members from the Secretary of State;(c) provision about the payment of remuneration and allowances to members.”Member’s explanatory statement
This new Clause would enable regulations to be made creating a statutory committee to provide advice to the Secretary of State in relation to medical devices.

[Lord Bethell (Con)]

My Lords, in moving Amendment 50, I shall speak also to Amendments 64 and 96. We have spoken extensively about the critical importance of patient safety and the need to improve medical device safety in bold new regulations going forwards. The need for medical device scrutiny to the highest standards was expressed by noble Lords throughout Grand Committee and, of course, in the report of my noble friend Lady Cumberlege. We recognise that improved and strengthened post-market surveillance and vigilance is essential. Equally, it is critical that we take further steps to strengthen oversight and increase transparency behind regulatory decision-making. Amendment 50 would support those efforts.

This new clause provides the Government with the power to create a statutory committee for independent expert advice on matters relating to medical devices. Historically, systems for post-market surveillance for medicines and medical devices have evolved differently. However, given scientific and technological advances and the kinds of innovative products and treatments becoming available, whether classed as medicines or medical devices, there is now need for greater assurance of equally high standards of surveillance, to ensure the upmost protection of patients.

The Commission on Human Medicines, which has a statutory basis in the human medicines regulations, provides an expert independent view to the MHRA on human medicines. It is visible and is underpinned by a statutory footing in the Human Medicines Regulations 2012. There is a parallel set of experts for medical devices. The Devices Expert Advisory Committee, or DEAC, advises the MHRA on medical devices but does not have an equivalent statutory footing.

Amendment 50 would change this. Subsection (1) provides a delegated power to establish a committee to advise on matters relating to medical devices. The aim is to strengthen the vigilance system for medical devices. A statutory committee for medical devices will support structured decision-making and formal accountability, allowing for clear roles and responsibilities for independent expert advice. This will strengthen the MHRA’s ability to manage safety issues which are identified in clinical use even more effectively, ensuring that timely decisions are made and appropriate action taken to protect patients.

Proposed new subsection (2) provides that regulations may include, among other things, provision about membership, matters which the committee may or must consider, and establishment of sub-committees. This subsection also allows for provision to be made regarding co-operation with other bodies with medical devices expertise and the Commission on Human Medicines, allowing for join-up and best use of our experts.

Proposed new subsection (3) lists matters that regulations under proposed new subsection (2)(a) in relation to membership may cover. This includes the number of members, their appointment, the circumstances in which they cease to be members, and requirements as to independence from the Secretary of State. Proposed new subsection 3(c) allows for provisions to be made about payment of remuneration and allowances to committee members.

The amendment also amends Clause 41, enabling regulations relating to the advisory committee to make consequential provisions. Pursuant to Clause 45, regulations are to be made by statutory instrument and subject to the affirmative procedure. We consider it appropriate that Parliament has the opportunity to scrutinise regulations made under this power, given that the placing of this committee on a statutory footing will be a key element of enhancing the safety of medical devices. These regulations will be subject to all the requirements in Clause 45: public consultation and use of the affirmative procedure; and allowing patients, and other stakeholders, to comment before regulations are made to establish the Committee.

Those regulations will set out clearly, and transparently, how the statutory committee would provide advice where the regulator identifies that there is a need for scientific, technical or clinical advice. They will set out requirements to engage patients in the advisory system; for timeframes for advice on safety concerns to be issued; and requirements to communicate publicly about new and emerging risks. Rightly, the public want more transparency and accountability in regulatory decision-making. They want clearer, greater communication and explanation relating to the performance of healthcare products in clinical use. Patients deserve clear and up-to-date information on the safety of healthcare products from credible and authoritative sources. This statutory committee will meet that need. A statutory devices advisory committee will give confidence to patients, as well as clinicians and the public, that the regulator will take account of expert views on medical devices in a fast-moving area of life sciences. It will create an equilibrium in the level of external advice informing regulatory decisions across all healthcare products.

There are two other amendments in my name in this group and I do not intend to dwell on them, as they are only minor and technical. Amendment 96 provides for consequential changes to allow the DEAC to be commenced. Amendment 64 makes a technical amendment in relation to the time limits for bringing prosecutions for an offence. Time limits already exist but, as part of the clarification of the enforcement regime in Part 3, changes were made to break the link between consumer protection legislation and medical devices, and to streamline the enforcement regime. Due to an oversight, the current time limit was removed but not then reinstated by the Bill into the medical device regulations. Without this change, the system would not function correctly. I beg to move.

Amendment 51 (to Amendment 50)

Moved by

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[Baroness Jolly (LD) [V]]

My Lords, we support these amendments from the Government and from the noble Baroness, Lady Thornton, which relate to the creation of a statutory committee to provide advice to the Secretary of State. Government Amendment 50 would allow the creation of such a committee in relation to medical devices, and the amendments in the name of the noble Baroness, Lady Thornton, in this group would require the Secretary of State to create the committee in Amendment 50, as the Government’s amendment states only that the Government “may” create the committee, not that they must.

No Secretary of State should be above independent advice. Amendment 50 is no bad thing, and of course any advisory committee on a statutory footing should consist of patients as well as experts. I understand that there might be kickback on the amendments in the name of the noble Baroness, Lady Thornton, but a Secretary of State will rarely have expertise in medical devices, so an ad hoc independent committee to inform, advise and warn would be very valuable. A lot of thought will need to be given to working out its terms of reference. We therefore support Amendments 51 to 53. As the noble Lord, Lord Lansley, said, it will also be critical to ensure how this committee will work alongside the MHRA.

[Lord Bethell (Con)]

My Lords, I am enormously thankful for that constructive debate. This change to the Devices Expert Advisory Committee should be welcomed. It provides for if not equivalence then equality between the medicines and medical devices regimes. It provides for transparency, which we value enormously, and it indicates our direction of travel, the step change and the commitment to patient safety that the MHRA will enshrine.

As has been noted, the committee already exists. It currently meets, and it has an impact and an effect, but these measures mean that it will be strengthened. This change is put forward not solely by the Government; it was a recommendation in the review authored by my noble friend Lady Cumberlege. It adds to the collective picture of improvements that we are making, from future regulation of devices to the medical devices information system. I reassure my noble friend Lord Lansley that we have a profound commitment to creating a regulator in the MHRA that has international influence. I say to the noble Lord, Lord Hunt, that patient representatives are already on the DEAC. As Dr June Raine made clear in her briefing to noble Lords, she and the MHRA are massively committed to the patient safety agenda and to mobilising the patient safety voice through instruments such as the DEAC but not solely through it.

It is a delegated power, but one that I hope noble Lords agree is contained. It will allow us to ensure that the structure and focus of the committee can be kept under review to make best use of its impact, and the regulations will be subject to public consultation and all the steps therein.

The noble Baroness, Lady Thornton, has tabled Amendments 51 to 53 to the government amendment, which would change the nature of the regulations such that they “must” rather than “may” be made. However, as I have set out, the committee already exists; it functions now. It will be strengthened by the regulations. We are committed to a more structured decision-making process that improves transparency. There is no equivocation or doubt; these regulations will be made.

The powers provided by Amendment 50 in my name will enable movement towards a more transparent, proactive, whole-life cycle approach to vigilance. Fundamentally, they will make a difference in the oversight of medical devices to the benefit of patients and patient safety.

I am grateful to noble Lords who have continued to shine a light on the importance of device safety. I hope that this additional tool in the arsenal demonstrates continued commitment and that I have provided sufficient reassurances for the noble Baroness to feel able to withdraw the amendment.

[Baroness Wheeler (Lab)]

I thank the Minister for his response and all noble Lords and noble Baronesses who have taken part in this useful debate. The points made by my noble friend Lord Hunt and the noble Lord, Lord Lansley, about the future role of regulation were particularly pertinent, and we look forward to seeing how it develops.

I understand the Minister’s response in relation to “may” or “must” and heard loudly his reassurance that there is no doubt that the committee will be established or be upgraded. That being the case, I am happy to withdraw the amendment.

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Moved by

[Lord Bethell]

54: Before Schedule 1, insert the following new Schedule—
“SCHEDULE A1 FURTHER PROVISION ABOUT THE COMMISSIONER FOR PATIENT SAFETYPrinciples relating to core duties
1_(1) The Commissioner must prepare and publish a set of principles to govern the way in which the Commissioner will carry out the Commissioner’s core duties.(2) The Commissioner—(a) may revise the principles, and(b) must publish any revised version.(3) The Commissioner must carry out a public consultation in preparing or revising the principles.Involvement of patients
2_(1) The Commissioner must take reasonable steps to involve patients in the discharge of the Commissioner’s core duties.(2) The Commissioner must in particular take reasonable steps to— (a) ensure that patients are aware of the Commissioner’s core duties and of how they may communicate with the Commissioner, and(b) consult patients, or persons who appear to the Commissioner to represent the interests of patients, on matters which the Commissioner proposes to consider in the discharge of the core duties.Supplementary functions and information
3_(1) For the purposes of carrying out the core duties, the Commissioner may—(a) make a report or recommendation to a relevant person;(b) consult or receive information from patients or any other person the Commissioner thinks appropriate;(c) request information from a relevant person;(d) share information with a relevant person.(2) A relevant person to whom a report or recommendation is made under sub-paragraph (1)(a) must provide a response to that report or recommendation within such period as the Commissioner may reasonably require.(3) A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner to provide information within such period as the Commissioner may reasonably require.(4) Nothing in this Schedule authorises a disclosure of information which contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this Schedule).(5) In this paragraph—“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;“health care” means all forms of health care provided for individuals, whether relating to physical or mental health, and including ancillary care;“relevant person” means—(a) a person who exercises functions of a public nature, relating to medicines or medical devices, so far as those functions are exercisable in relation to England;(b) any other person who, in the course of providing health care, provides services relating to medicines or medical devices in relation to England.Individual cases
4_(1) The Commissioner may not exercise functions in relation to an individual case.(2) But sub-paragraph (1) does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue.Amendments to primary legislation
5_(1) In Part 1 of the Table at the end of paragraph 3 of Schedule 1 to the Public Records Act 1958 (definition of public records), at the appropriate place insert—“Commissioner for Patient Safety.”(2) In Part 3 of Schedule 1 to the House of Commons Disqualification Act 1975 (offices disqualifying for membership), at the appropriate place insert—“Commissioner for Patient Safety.”(3) In Part 6 of Schedule 1 to the Freedom of Information Act 2000 (other public bodies and offices: general), at the appropriate place insert—“The Commissioner for Patient Safety.”(4) In section 71 of the National Health Service Act 2006 (schemes for meeting losses and liabilities etc of certain health service bodies), in subsection (2), before paragraph (h) insert—“(ga) the Commissioner for Patient Safety,”. (5) In Part 1 of Schedule 19 to the Equality Act 2010 (authorities subject to the public sector equality duty), in the group of entries under the heading “Health, social care and social security”, at the appropriate place insert—“The Commissioner for Patient Safety.”Regulations about appointment and operation
6_(1) The Secretary of State may by regulations make such provision as the Secretary of State considers appropriate with regard to the appointment and operation of the Commissioner.(2) Regulations under sub-paragraph (1) may (among other things) contain provision for and about—(a) the Commissioner’s terms of office;(b) remuneration or other benefits;(c) the provision of financial or other assistance, including staff, accommodation, equipment or other facilities, for the Commissioner;(d) requirements to prepare business plans;(e) requirements to prepare reports;(f) requirements to lay documents before Parliament;(g) requirements to provide documents to the Secretary of State or other persons specified in the regulations;(h) the conferring of functions on other persons in relation to the Commissioner;(i) the appointment of a board to provide advice to the Commissioner.”Member’s explanatory statement
This amendment makes further provision about the Commissioner for Patient Safety established by the amendment in the Minister’s name to insert a new Part before Part 1.

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Moved by

[Lord Bethell]

55: Clause 37, page 22, line 1, after “a” insert “relevant”
Member’s explanatory statement
This amendment and the amendment to clause 37 in the Minister’s name adding a definition of “relevant person” restrict the persons to whom information may be disclosed in reliance on Clause 37(5).

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Moved by

[Lord Bethell]

58: Clause 37, page 22, line 4, leave out “But”
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name adding a new subsection (5A) to Clause 37.

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Moved by

[Lord Bethell]

64: Schedule 2, page 39, line 39, at end insert—
“(2A) In respect of an offence under this regulation—(a) a magistrates’ court in England and Wales may try an information laid before the earlier of—(i) the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and(ii) the end of the period of three years beginning with the day on which the offence was committed;(b) a magistrates’ court in Northern Ireland may hear and determine any complaint made before the earlier of—(i) the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and(ii) the end of the period of three years beginning with the day on which the offence was committed;(c) in Scotland, summary proceedings for the offence may be commenced before the earlier of—(i) the end of the period of one year beginning with the day on which evidence which the prosecutor thinks is sufficient to justify a prosecution comes to the knowledge of the prosecutor, and(ii) the end of the period of three years beginning with the day on which the offence was committed.(2B) For the purposes of paragraph (2A)(a)(i), (b)(i) and (c)(i)—(a) a certificate signed by or on behalf of the prosecutor and stating the date on which such evidence came to the prosecutor’s knowledge is conclusive evidence of that fact, and(b) a certificate stating that matter and purporting to be so signed is to be treated as so signed until the contrary is proved.” Member’s explanatory statement
This amendment ensures that prosecutions for an offence under new regulation 60A of the Medical Devices Regulations 2002 can be brought before the earlier of one year from the prosecutor thinking there was sufficient evidence to justify a prosecution or three years of the commission of the offence, as is currently the case with regard to equivalent offences under section 12 of the Consumer Protection Act 1987.

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[Baroness Jolly (LD) [V]]

This amendment from the noble Lord, Lord Hunt of Kings Heath, supported by the noble Baronesses, Lady Cumberlege and Lady Bennett, would require the Secretary of State to introduce proposals for a redress agency for those harmed by medicines and medical devices. As the noble Lord, Lord Hunt of Kings Heath, said, the concept of a redress agency for those harmed in such a manner has been around for many years but has not been realised. However, in the light of the Cumberlege report, which has been a great catalyst for innovation, the Government must see that now is the time. This is a really practical and common-sense move that would provide support and relief for patients while also avoiding the need for costly litigation on both sides, saving the NHS a considerable amount of money which could be better spent.

The NHS has a duty to give proper support to those in its care who have been harmed. As the noble Lord, Lord Lansley, said, there needs to be independent fact-finding, leading to a resolution process. He cited the NHS Redress Act 2006. I ask the Minister to reflect on this debate and to speak to his right honourable friend the Secretary of State, perhaps using his charm to persuade him to think again.

One advantage of being at home for this debate, in front of your own computer in your own study, is the opportunity quickly to look online to see how easy it is to find the relevant website. It took me a couple of searches before I came up with NHS Resolution, but it was not hugely helpful or intuitive. Therefore, would the Minister also feed that back to the Secretary of State and the people who manage these schemes?

[Lord Bethell (Con)]

My Lords, the noble Lord, Lord Hunt of Kings Heath, raises matters in Amendment 67 that he raised in Grand Committee. I completely recognise that they are of enormous concern right across the House. One could say that it is the £83 billion question. I know he is an advocate, as indeed are many noble Lords, of the conclusions of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege, and I commend him and other former Health Ministers in this place.

In Committee, we had a very helpful, substantial and informative discussion on the concept and merits of a redress agency. I know that the noble Lord indicated that he would return to these matters if it seemed likely that we were unable to give an update on the way in which the department is responding to the review. I understand that he seeks further assurances and I shall attempt to give them.

As I set out in Committee, we are determined to ensure the safety of medicines and devices so that harm is less likely to happen in the first place, and, when things do go wrong, we are committed to fair redress arrangements that work for all. However, for the reasons that I set out in Committee, we do not believe it is necessary to create a new body for the purpose of providing redress for medicines and devices.

First, routes already exist if patients believe they were harmed by medicines or medical devices. They can bring a legal claim in the courts either against the manufacturer on the basis of product liability or against the actions of an NHS provider or clinician.

Secondly, the Government and manufacturers already have the ability to set up redress schemes when necessary, and in fact they have done so already, where appropriate, without ever establishing an additional agency. Setting up an overarching redress agency could become an unnecessary addition to an already complex landscape.

Thirdly, we do not believe that a redress agency in this country would necessarily make products safer or drive the right incentives for industries which are usually directed from a global level. It is a fact of life that any extra costs to firms could impact the attractiveness of the UK as a place to market and manufacture products —something that we are committed to supporting.

The noble Lord, Lord Hunt, asked what, in the absence of wholesale changes, we are doing to improve things. Since its strategy, Delivering Fair Resolution and Learning From Harm, was launched in 2017, NHS Resolution has successfully reduced the number of cases going to litigation. In its 2019-20 accounts, it reported that 71% of claims are now resolved without court hearings, which is extremely encouraging.

This has been accompanied by a significant increase in the use of ADR—alternative dispute resolution, referred to by my noble friend Lord Lansley—with over 1,000 mediations undertaken by 31 March 2020, with a success rate of around 80%. This is again encouraging. As a result of the strategies employed on ADR and early resolution, overall time to resolution of cases had reduced since the NAO report by an average of 26 days. The new early notification scheme for obstetric cerebral palsy has ensured that many early admissions of liability and interim payments can be made to families within months. In answer to my noble friend Lord Lansley, we keep the whole arrangement under review and assess options all the time.

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[Lord Hunt of Kings Heath (Lab) [V]]

I very much agree with the noble Baroness, Lady Jolly, that this afternoon we have given a powerful signal to the Government. Certainly, from these Benches, we very much support her amendment and her efforts to get redress for people who were grievously damaged by procedures undertaken in the National Health Service.

The noble Lord, Lord O’Shaughnessy, talked about one woman’s experience of the impact of surgical mesh, and the huge pain and damage inflicted. I was very grateful to him when I had a Question on surgical mesh, which he answered, as watching it from the Gallery were a group of women from Sling the Mesh, who I had brought in. He gave a lot of time to them afterwards; perhaps it paved the way to the inquiry established under the chairmanship of the noble Baroness, Lady Cumberlege. Like him, meeting those women and talking to them about what they had suffered made me absolutely determined to do anything I could to raise the issue.

We were very fortunate that the noble Baroness, Lady Cumberlege, accepted the chairmanship of this inquiry, given the quality of her team and the extraordinary lengths to which she went to produce its very fine report. Anyone who has met the people involved and listened to the suffering that they have undertaken is left with a feeling that it is awful. Something must be done for them and I very much hope that the Minister will be sympathetic.

[Lord Bethell (Con)]

My Lords, what a moving and heartrending set of speeches on a very important amendment, which I take extremely seriously. It raises the issue of establishing a specific redress scheme for those medicines and medical devices considered by the review: sodium valproate, the use of pelvic mesh and hormone pregnancy tests. The stories in the review, which have been told here this afternoon, are extremely moving on every single level. I cannot but pay testimony to those who have conducted the campaign and given evidence about their own personal suffering—and who, quite reasonably, look for some form of redress.

I completely understand why my noble friend Lady Cumberlege has raised this issue and why she and other noble Lords have asked for progress on her review. I also completely understand the importance that she and her team attach to this recommendation. They rightly spent considerable time drawing on a wide range of complex evidence before reaching their recommendations. The Government feel it is only right that we also give that incredibly helpful report our full consideration before responding to its recommendations. I remind noble Lords about the timeline for a response to these kinds of reviews, which we have gone over before. I think we are well within the normal response time for such reviews, Covid notwithstanding.

In order to determine whether redress schemes should be established, the Government have a duty to ensure that the final decision is fair for patients and for citizens more generally—not just the patients and citizens affected by the three treatments that my noble friend Lady Cumberlege alluded to, but all citizens and patients; you cannot favour someone over another. This requires extremely careful consideration of any proposed scheme but also the precedent that any decision sets for future policy-making. We spoke in the previous debate about the £83 billion problem. That kind of financial impact has a profound bearing on this kind of discussion.

My noble friend Lady Cumberlege asked when the Government will respond to her review. The Written Ministerial Statement of 11 January sets out the Government’s interim response. I emphasise to anyone who may be confused that it is just an interim response to the report of the IMMDS review. We currently plan to respond to the report later this year; that is a commitment made by my honourable friend Nadine Dorries, the Minister in the other place. The report took over two years to compile and we therefore consider it absolutely vital for the sake of patients, especially those who have suffered greatly, to give this recommendation the full consideration it deserves.

The noble Baroness, Lady Bennett, asked why the Government have established redress schemes in the past but are unwilling to commit to the schemes proposed in this amendment. I think that one is too early to call. It is right and proper for the Government to carefully consider proposals for redress schemes on their own merits to ensure a fair outcome for patients, and citizens more generally.

The noble Lord, Lord Hunt, asked why it is taking so long to consider the recommendations. The report took over two years to compile, so we need to consider it very carefully. I do not want to use the Covid pandemic as a catch-all excuse, but the reality is that our hospitals are overwhelmed; the Department of Health has doubled in size in the last six months and even with that it is overworked and overstretched. The resources and capacity to respond to this kind of report are, I am afraid, distracted on other matters of national health crisis. However, I reassure the noble Baroness, Lady Cumberlege, and other noble Lords who have spoken that work is under way and we will set out the Government’s response to this report later this year.

I could not help but be enormously moved by the testimony of the noble Lord, Lord O’Shaughnessy. In essence, he asked why the Government do not recognise that the patients highlighted in the report of the medicines and medical devices review suffered unavoidable harm, particularly those who took hormone pregnancy tests. The Government absolutely do regard their suffering most seriously indeed and are considering the contents of the report. I am restricted in what I can see regarding hormone pregnancy tests in particular, given the live litigation, but I want to make clear the Government’s position regarding a causal association between HPTs and adverse outcomes in pregnancy. The scientific evidence has been reviewed on a number of occasions, most notably by the Commission on Human Medicines expert working group on HPTs, which, as noble Lords will know, reporting its findings in November 2017. The EWG concluded that the scientific evidence did not support a causal association and that remains the Government’s position.

Just as Covid-19 impacted the publication of the report, it has also had an impact on the timing of our response. I know, and recognise, that that is enormously frustrating. The Government are committed to responding and I assure the noble Baroness, Lady Cumberlege, that work is under way. Our upcoming full response will address recommendation number four. We are moved by the stories; I am totally and utterly sympathetic to the situation that the patients affected by these conditions find themselves in on a day-to-day basis. They are still living through it today. I would like to regard myself as a compassionate person, but it is not appropriate to make policy on this kind of matter through primary legislation. For that reason, I ask my noble friend to withdraw her amendment and await the Government’s full response to her report.

[Baroness Cumberlege (Con) [V]]

My Lords, I am so grateful to noble Lords who have taken part in this debate. It has been quite short, but it is very important. As the noble Baroness, Lady Bennett, said in the previous debate on the agency, she has been involved with this Bill in a way that she did not anticipate. She has been such a stalwart, coming to my rescue on occasions, and supporting so much of what has been in the Bill from other sources. I thank her for all of that. The noble Lord, Lord O’Shaughnessy, made a powerful speech about the individuals he has met. We know Susan Morgan well; we have worked with Janet and Emma and many others who have led their own organisations. We think of patient groups as being a few people who got together—when we did not have lockdown—to have coffee and just discuss life generally. That is not the case.

One of the groups I know has 8,500 members—from all over the world, in fact. Other groups have an equal number of members, or numbers of that order. So these are important organisations. They know what it is to have real research. They come up with not just experiences; they beaver away at all our institutions, they look at what they are producing and they challenge. They are so valuable. In the way they work, when they are people who are in considerable pain—very often, they have complicated and difficult lives, having to deal with constant pain—they are thinking of others all the time. That really is so uplifting.

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Moved by

[Lord Bethell]

70: Clause 41, page 25, line 43, at end insert—
“(1) This section applies to regulations under a power in Part A1, 1, 2 or 3, apart from regulations under paragraph 9 of Schedule 1.”Member’s explanatory statement
This amendment is consequential on the Minister’s amendments to insert a new Part before Part 1 and a new Clause after Clause 18, and would enable regulations under powers in those provisions to make consequential and other connected provision.

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Moved by

[Lord Bethell]

72: Clause 43, page 26, line 13, after “Part” insert “A1,”
Member’s explanatory statement
This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety. It requires the Secretary of State to carry out a public consultation before making regulations about the Commissioner.

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Moved by

[Lord Bethell]

75: Clause 44, page 26, line 43, leave out “Secretary of State must lay before Parliament” and insert “relevant authority must lay before the appropriate legislature”
Member’s explanatory statement
This amendment and the other amendments to Clause 44 in the Minister’s name extend reporting obligations under Clause 44 so they apply in respect of regulations made by a Northern Ireland department and in respect of regulations under Clause 18.

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Moved by

[Lord Bethell]

79: Clause 44, page 27, line 3, leave out “Secretary of State” and insert “relevant authority”
Member’s explanatory statement
See the explanatory statement for the first amendment to Clause 44 in the Minister’s name.

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Moved by

[Lord Bethell]

86: Clause 45, page 27, line 16, after “Part” insert “A1,”
Member’s explanatory statement
This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety.

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Moved by

[Lord Bethell]

91: Clause 45, page 28, line 12, after “Part” insert “A1,”
Member’s explanatory statement
This amendment is consequential on the amendments in the Minister’s name inserting a new Part relating to the Commissioner for Patient Safety. It provides for regulations about the Commissioner to be subject to the draft affirmative procedure.

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Moved by

[Lord Bethell]

94: Clause 47, page 30, line 2, at end insert—
“(ba) section 5(4),”Member’s explanatory statement
This amendment would commence the definition of “human medicines provision” from the day on which the Bill is passed.

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Moved by

[Lord Bethell]

97: In the Title, line 1, at beginning insert “Make provision about a Commissioner for Patient Safety in relation to human medicines and medical devices;”
Member’s explanatory statement
This amendment would add a limb to the long title in relation to the new provisions tabled in the Minister’s name for the purpose of establishing a Commissioner for Patient Safety.

Covid-19: Variant

Lord Bethell Excerpts

Wednesday 13th January 2021 Lords Chamber

[Lord Scriven]

To ask Her Majesty’s Government when they first became aware (1) of the new variant of COVID-19, and (2) that such a variant of the virus was prevalent in the areas placed into Tier 4 on 20 December 2020.

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

My Lords, the second variant is a very serious matter. On 8 December, analysis of all genomes available in Kent showed that a new variant was circulating. Ministers were notified on 11 December. On Monday 14 December, the Health Secretary informed Parliament, PHE released a statement and the Government held a press conference on the new variant.

[Lord Scriven (LD) [V]]

My Lords, variant B117 was identified in October. From the second week of December, virus cases started to rocket in London and the south-east, yet the Government’s focus was on how to keep people mixing at Christmas, not on dealing with the alarming spread of the virus, ignoring public health experts who said that a tight lockdown was urgently required. What message of apology does the Minister have for those families attending funerals because the Government acted too slowly to help save lives?

[Lord Bethell (Con)]

My Lords, I am afraid that I just do not recognise the noble Lord’s proposition. Hundreds, if not thousands, of new variants are appearing all the time. Many of them have passed through the process, but identifying those that are threatening, have more transmissibility and are significantly different is extremely complex. As I said very clearly, it was on 8 December that, after analysing all the genomes available in Kent, we showed that an important new variant was circulating.

[Lord Winston (Lab) [V]]

My Lords, clearly these variants are extremely—[Inaudible]—for all sorts of reasons. Regrettably, the Minister did not answer the question put by my noble friend Lady Thornton yesterday, when she questioned incomplete vaccination. Can the Minister give us clear figures on the risk of mutant varieties of the virus with a longer period between the two injections of the Pfizer vaccine?

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[Lord Bethell (Con)]

My Lords, the noble Lord has more medical expertise than me to be able to answer that question, but the briefing that I have is that the significant mutation in the Kent variant is not of a kind that should affect the efficacy of either a single dose or two doses of the vaccine. This comes as a significant relief to the vaccine programme. We remain on the balls of our feet, looking out for any variations that might affect vaccine deployment, but at this stage we have not found anything that poses a significant threat.

[Baroness Barker (LD)]

My Lords, the ONS data in the second week of December showed that the number of cases from all variants of the virus had rocketed. Why did the Government fail to act on that information until late December?

[Lord Bethell (Con)]

The noble Baroness is entirely right that the EpiData showed that the figures shot up in December; that is exactly why we looked extremely carefully at the genomic data from Kent and other places. As she knows, genomic data takes time to process—the tests can take a week to turn around. Looking at all the variants and matching EpiData figures with genomic data is an enormously complicated mathematical task. We moved as swiftly as possible and far faster than in many other countries.

[Lord Farmer (Con)]

My Lords, at the Downing Street press conference of 5 January, we were told that people had protection from the new variant if they had already been infected. What is the Government’s estimate of the number of people in the UK who now have antibodies after contracting the virus and are therefore likely to be immune? What is their approach to the large population of such people, estimated by Professor Neil Ferguson to be at 25% to 30% in London, and their need for vaccination?

[Lord Bethell (Con)]

My Lords, PHE weekly seroprevalence data suggests that antibody prevalence among blood donors aged 16-plus in England is 6.9%, which is consistent with other data that we have. The MHRA has considered this and has decided that vaccinating is just as important for those who have had Covid-19 as it is for those who have not.

[Baroness Finlay of Llandaff (CB) [V]]

How are demographic and NHS outcome data and test results from patients across the UK being collated to identify patterns suggesting further new variants, reinfections, changes in risk factors to severe disease, such as malnutrition, and planning for managing long Covid and modelling ICU provision?

[Lord Bethell (Con)]

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

[Baroness Thornton (Lab) [V]]

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

[Lord Bethell (Con)]

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

[Baroness Bowles of Berkhamsted (LD) [V]]

As part of the science, mathematicians run numbers on the spread of variants in an attempt to see whether one is getting an edge; these saw the new variant gaining in the east of England and London by November. Why did a significant localised increase in one variant not trigger an immediate precautionary response, rather than prevarication that it might be about behaviour? What evidence is there that behaviour can favour one variant over another?

[Lord Bethell (Con)]

I am terribly sorry but the noble Baroness is not right about that chronology. Through backward tracing and by looking at historic data, we were able to identify that the variant had been present in Kent as far back as September, but it was only through backward tracing that we were able to figure that out. Further analysis was commissioned on 18 December and NERVTAG concluded that the variant was much more transmissible than others in circulation. Before that, we relied on hunches. When the science changed, so did our decisions.

[Lord Truscott (Ind Lab) [V]]

Andrew Miller, president of the Australian Medical Association in Western Australia, said:

“Until we get more data that shows that AstraZeneca is as good as the others, the scientific and medical risk that you take is that you won’t get herd immunity. The political risk is that you will get a good vaccine for the rich and a not so good vaccine for the poor.”


Is it not just a fact that the AstraZeneca vaccine is better than nothing but it will not stop the pandemic—especially the new variant?

[Lord Bethell (Con)]

I categorically reject that analysis. All the vaccines are effective. The MHRA and the JCVI have been explicit about that, and I invite the noble Lord to look at the data.

[Lord Randall of Uxbridge (Con) [V]]

My Lords, my noble friend rightly underlines that new variants are appearing not just here but anywhere in the world. Can he explain the process for notifying such variants worldwide and say how any assessment of their characteristics is passed on?

[Lord Bethell (Con)]

My noble friend asks a very challenging question. The honest truth is that we have to look at the systems whereby that data is exchanged. CMOs around the world have extremely regular contact with each other, and a lot of the data is exchanged through the formal links of the scientific community. But I think that there is a case for more structured intergovernmental exchange of data about the new variants, because this will be the major challenge of the year ahead.

[Viscount Waverley (CB)]

The Minister mentioned a number of countries. Is there sufficient exchange between all of them or could more be done in that regard? Is there anything that the public could usefully know about the new variant’s transmission traits—whether it is airborne, for example?

[Lord Bethell (Con)]

The exchange of information between the scientific community has worked extremely well during this pandemic and epidemic, and I pay tribute to it for the open-hearted and transparent way in which it has exchanged data across political, cultural and national boundaries. In terms of transmission, the noble Viscount alludes to something that is very difficult to pin down. It is not clear what proportion of the disease is transmitted through the air and what proportion by touch and manual transmissibility. That is a very frustrating conundrum. The CMO guides us to believe that there is more transmissibility through the air than by touch, but it is absolutely essential that people keep their distance and wash their hands.

[The Lord Speaker (Lord Fowler)]

My Lords, the time allowed for this Question has elapsed. We now come to the third Oral Question.

Covid-19: Vaccinations

Lord Bethell Excerpts

Wednesday 13th January 2021 Lords Chamber

[Baroness Brinton (LD) [V]]

My Lords, I welcome this Statement on the on the vaccine strategy and rollout, which we have been asking for from these Benches, in both Houses, since before the first lockdown. The Government have rightly set themselves stretching targets and we agree with them, especially in the light of the new variant’s high levels of transmission. The news this week of the severe problems that our NHS is facing across the country shows how out of control the virus is at the moment. Individuals must comply with the spirit and the rules of lockdown to help to reduce cases as soon as possible.

The Prime Minister has talked repeatedly about a vaccine signalling the end of the pandemic. I fear that lax messaging about the hope that vaccines bring is hampering the message about lockdown. It is a relief to hear in this Statement a more measured tone about this being a staging post in a long journey. Please can somebody tell the Prime Minister? The Minister will know that epidemiologists repeatedly make the point that we are a long way from life returning to normal. I note, for example, that in the debate about the vaccination priority list, the advice to clinically vulnerable people from government is that, even after their vaccine, they must remain shielding until told that it is safe for them not to shield.

On supply, we remain concerned that the Government will struggle to reach 2 million a week by next week—mid-January—given the numbers of vaccines being delivered this week. We are also receiving reports from GP surgeries of fewer doses arriving than ordered or, worse, short-notice cancellation of orders causing administrative chaos for already hard-pressed administrative surgery staff. While the opening of super vaccine hubs is welcome, can the Minister say why the hubs are vaccinating only during the day? If it is truly a priority to vaccinate as many people as possible, arrangements should be made for close to 24/7 delivery. I hear that, in the last hour, the Prime Minister has announced that the Government will try to start a pilot of some 24/7 hubs as soon as supplies permit—but how soon is soon? What are the vaccine supply pinch points? It is clear that targets are already slipping. This week, the target of 2 million a week has moved from mid-January to the end of January, and it is now the end of March instead of the end of February for the top five priority groups. Is this for the supply of all three approved vaccines, or just the AZ vaccine, where there is a much larger order to be rolled out with more substantial delays if there are supply pinch points? Also, it is because of a shortage of glass vials, or vaccine manufacture and regulation checks?

What are the Government doing to ensure that vaccine hubs are not superspreader locations? There have been worrying reports about people being asked to change masks and sit and wait less than two metres away from other people in the vaccine hubs. Given that the first five priority groups are all high-risk people, the last thing the NHS should be doing is encouraging them to go to areas that do not follow the government guidance on “hands, face, space”. Inevitably, there are glitches with any new process. We are still hearing of problems with the Pinnacle IT system that is being used for vaccinations. Some hubs were resorting to pen and paper in despair, and there are further problems reported with patients being asked to give the same detailed answers to a group of questions about Covid symptoms and allergies as they arrived, as they were registered and then as they were being given their jab. Any effective IT system should enter that information once. IT delays are reported as causing major delays, queues outside centres and daily targets missed at hubs. Can the Minister say what is being done to remedy these problems?

Can the Minister also say whether the vaccine dashboard will separate out the number of care home residents vaccinated? I see that care home cases are increasing again, which we deplore. As earlier this year, we strongly object to Covid patients being sent from hospitals into care homes, unless they are specialist Covid-designated units separated from other non-Covid residents. Even better would be to follow the example of Southampton hospital, which is using local hotels as step-down facilities. Will the Government endorse this and ensure that care home patients are kept safe through this surge until they are vaccinated?

The Government have announced that fewer than 1,300 surgeries and pharmacies are approved to deliver vaccines. The large hubs are all in urban areas. What will the Government do in rural areas, where elderly people do not have access to transport and may have to travel considerably further than the 90-minute journey for vaccinations announced this week? Are there plans as yet unannounced to increase substantially truly local-level provision, at a high-street level, in every rural village and small town—whether at a local surgery, pharmacy or visiting mobile vaccination unit—to ensure that vulnerable people who cannot travel or take the risk of infection will get access to the vaccine? It is not good enough for the Government to say that vaccines have been offered if the patients concerned cannot get to the vaccination delivery point.

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

My Lords, I am enormously grateful for the detailed questions from the noble Baronesses. In particular, I endorse the words of the noble Baroness, Lady Thornton: it is indeed a remarkable achievement to have invested in such a broad array of candidates and to have purchased such an enormous quantity of doses—367 million. This is indeed a profoundly important step by the Government and one that we should celebrate and take pride in.

However, I acknowledge the searching questions from the noble Baronesses, so let me try to cover as much ground as I possibly can. The noble Baroness, Lady Thornton, asked about the digital backbone. This is absolutely critical to vaccine delivery. In many ways, injecting it into arms is the simple bit. Capturing the records, getting the invitations out right and the process of establishing identity are absolutely critical; in any project of this scale and complexity, that is where the problems are most likely to happen. That is why I pay tribute to colleagues at NHSX, NHS D, Test and Trace, PHE and elsewhere in the NHS who have done an amazing job of bringing together patient records around the nation to ensure that the invitations are sent out promptly and accurately and that the records are captured correctly. That information will be absolutely essential to both pharmacovigilance and the policy assessment of key issues such as transmissibility and efficacy. It employs the yellow card system to spot adverse incidents, and all data will go straight into the GP record, which is profoundly important when it comes to the research and analysis of the rollout of the vaccine. These may seem like prosaic details, but it is the most enormous digital achievement and one that will have an amazing impact on the health of the nation. I enormously encourage everyone in the country to ensure that they know their GP number, that they are properly registered with their GP and that they respond to any correspondence about the vaccine.

The noble Baroness, Lady Thornton, characterised the vaccine rollout as “traditional”. Can I just push back gently on that suggestion? There is nothing traditional about the sheer scale of this rollout, or about its speed and complexity. Our approach has been to work through the NHS, and from that point of view it might seem traditional, but I reassure noble Lords that not only is the latest technology being used but there is also the complexity of the collaboration between all the different parts of government—the Army, the NHS and PHE. Every single relevant part of government is being employed in this huge task, and it is something we should be enormously proud of.

The noble Baroness, Lady Thornton, asked about the supply figures. I am pleased to tell her that AstraZeneca has confirmed that it will be supplying 2 million vaccines a week. That is an enormous sum and it will mean that we can hit some really ambitious targets. Some 14.5 million people will be vaccinated by mid-February. Those are in categories 1 to 4, which includes care home residents and residential care workers, and they represent 88% of the mortalities in hospital. That will be transformational to the resilience of our healthcare system and to our approach to the pandemic. Some 17 million further people from categories 5 to 9 will be vaccinated by the end of spring, and all adults over 18—52 million of them—will be offered the vaccine by the autumn. That is a massive achievement.

The noble Baroness, Lady Brinton, quite rightly emphasised that this does not change absolutely everything overnight. She asked, quite reasonably, about schools and workplaces. I can confirm that there is still a huge amount to do by the entire nation to ensure that we do not have high infection rates, that we still deploy testing in order to break the chains of transmission and that we understand how to keep infection down—because the tragic thing about this awful virus is that it hits the old and infirm, who can be protected by the vaccine, but it also hits the young. It has become very clear from recent hospital admissions and from our growing understanding of long Covid that this disease hits all parts of society, and although we will have the most afflicted vaccinated by the spring, this is still going to be a societal challenge for months to come.

The noble Baroness, Lady Brinton, mentioned the letters to those shielding, which suggest that people should still remain shielded. That is a really important point and one we have to resolve, because those who are shielded who may go out into the community can themselves still be vectors of transmission. Those very people who we have done so much to protect may themselves be transmissible. Therefore, people are going from being protected to being potentially dangerous to others, and this is going to be a mind shift that we will all have to go through.

The noble Baroness, Lady Brinton, asked about GP surgeries. I acknowledge her point. There have undoubtedly been stories of GP surgeries which have set up queues of people to be vaccinated and then there has not been a delivery of the vaccine. However, I reassure the Chamber that it has been a very small minority. More than 95% of vaccination deliveries have happened on time, and in the grand scheme of things I take the view that if some GP surgeries have stood people up and asked them to come back another time, that is a small price to pay to ensure that the greatest number of people can be vaccinated as fast as possible.

The noble Baroness, Lady Thornton, asked about London. It is true that if we look at the infection rate, London has a relatively small distribution of the vaccine, but we are a young city here in London, so it makes sense that we have a lower proportion of vaccination. There are 2.8 million people who are more than 80 years old in the country. Not many of them are found in London, which is why the London figures look as they do.

On pharmacies, I reassure all noble Lords who have asked me about this that my colleague in the other place, Nadhim Zahawi, is incredibly energetic in engaging pharmacy chains and community pharmacies. It is true that we have a pilot with hundreds of pharmacies already running in it, but it is very much our intention to work closely with pharmacies to deploy the vaccine. As noble Lords know, vaccines come in plates of 1,000. It is much easier to deploy those plates in large centres than in small ones. We are working extremely hard to break those packages down into smaller groups and to get those groups into smaller locations but, quite reasonably, in order to get the vaccine into the most arms possible, we are starting with the big centres.

The noble Baroness, Lady Brinton, asked me about hygiene management in the distribution of the vaccine. She is entirely right: if you have a small room, such as a GP surgery, and you have a large queue of people, it is going to be extremely difficult to keep them all separated. That is why the development of these seven massive distribution centres in such places as the ExCel and Millennium Point in Birmingham is such an important development, because there is the space to be able to move very large numbers of people safely through the process. They will have a huge impact when they are opened next week.

On 24/7 vaccination, I am pleased to say that the Prime Minister has made an announcement on that. I must share with noble Lords that there has not been an overwhelming consumer demand for vaccinations at 4 am, but we are going to try this out as a process, and if there is indeed a big demand for late-night vaccination, then we will step up to the opportunity.

I was asked about rural distribution. Yes, it is incredibly important to get through to rural communities, particularly as many of the elderly and infirm can be found outside the city centres. I reassure noble Lords that, before very long, we will have vaccination centres within 10 miles of all communities. The noble Baroness, Lady Brinton, is entirely right to say that there will be some people for whom we have to take the vaccination to them; we cannot expect them all to drive to a vaccine centre. Provisions are being made through local health authorities in order to ensure that that is delivered.

[The Deputy Speaker (Lord Duncan of Springbank) (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 Blencathra (Con)]

My Lords, will my noble friend accept my congratulations? The Government have done an absolutely magnificent job on vaccinations. They bought more than enough of the right vaccine, approved it first in the world, injected it first in the world and have vaccinated more people than the whole of Europe put together. I hope the Government will now not be distracted by some of the pathetic media trivia we have heard about how far you can ride a bike, whether a Scotch egg is a meal, whether it is 2 metres or 3 metres, or tier 3 or 4, or whether things have been too fast or too slow. Does my noble friend agree that the only thing that matters now is vaccinating all our people, in the whole of the United Kingdom, as quickly as possible—and 24/7 if vaccine supplies permit—to build on the success we have had so far?

[Lord Bethell (Con)]

My Lords, I am enormously grateful for my noble friend’s kind words. I think that, as a Government, we would prefer to be judged at the third act of this important performance, so I think it is probably too early to take too much praise, but I would like to say a massive thanks to the British nation.

In three ways, the nation has really stood up. The amount of collaboration between different groups—I alluded to it in my previous answer—between the Army, industry, the NHS and local authorities has been enormous. At the beginning of this pandemic, there were arthritic elements to the way in which Britain is governed that meant that different parts of our political and administrative machinery did grind into action slightly slowly, but, my goodness, over the vaccine deployment it has been absolutely athletic, and I take my hat off to every part of the machinery of government. On the union, this has been such a strong example of a national solution: all of Britain has come together in order to purchase and deploy the vaccine. Lastly, I would observe the resilience of the British public. It makes me enormously proud that the country puts the elderly and the infirm first and stands by and celebrates the weakest and most vulnerable in our society being put first in the queue. That is a national quality we should all be proud of.

[Lord Crisp (CB) [V]]

My Lords, I congratulate everyone concerned in the progress being made with the vaccinations, while recognising that there are issues to be addressed, not least that of accelerating the whole process. In passing, I note that I would be very happy to be vaccinated at 4 am if it sped things up. I will ask about testing and vaccination for a particularly vulnerable group; children excluded from school are the among the most vulnerable in the country, and I pay tribute to the approved alternative education providers and others working with them during the pandemic. I have been contacted by one of the directors of one of these providers, who tells me that, unlike schools, they are not being provided with lateral flow tests to help them protect children in school and staff. If I write to the Minister, will he take the matter up? Can he ensure that all such approved providers receive the tests and that their staff are given a high priority for vaccination—at least as high as that for teachers?

[Lord Bethell (Con)]

I am grateful to the noble Lord for flagging this important issue. He is entirely right that those who are sometimes overlooked by society and fall between the cracks are often those who either suffer from the disease or are vectors of infection. It is a public health priority to ensure that people such as those excluded from schools are not overlooked or in any way left behind. I would be very grateful if he could write to me with the details.

[Lord Winston (Lab) [V]]

My Lords, speaking from these Benches, I think it would be appropriate to thank the noble Lord, Lord Bethell, very much for the amazing amount of work he has been doing on this very difficult issue. I hope he will continue to take our concerns back to the Department of Health and the Government in general, because that seems very important. I join my noble friend Lady Thornton in congratulating the Government on getting vaccines out, but, with all due respect, Israel has already vaccinated over one-fifth of its population with a massive vaccine campaign. On the important issue of dividing the time of the Pfizer vaccine, many of us have given informed consent for a period of three weeks between the two injections; by extending that period, we now risk not obeying the consent issue, and therefore there is an ethical problem. Could the noble Lord address that issue, because it is of considerable importance, certainly increasing the risk of suspicion of the vaccine, already very prevalent in parts of the population?

[Lord Bethell (Con)]

I am extremely grateful for the noble Lord’s kind words. I know lawyers looked at the question he raises on informed consent; I am afraid I do not have the precise answer at the Dispatch Box right now, but I will be glad to write to him with a clarification.

[Lord Scriven (LD) [V]]

Up here in the north, the Yorkshire Post is running a “shot in the arm” campaign to get the Government urgently to allow the local community pharmacists who are screaming out to get jabs in people’s arms to do so. Why are the Government using excuses about batches of 1,000 for the AstraZeneca vaccine getting in the way of using these safe places on the high street that will improve access in the take-up of the vaccine?

[Lord Bethell (Con)]

My Lords, I am not sure we are using excuses; we are observing practical matters. The priority, quite reasonably, is to get the vaccine in as many arms as possible. We are totally committed to comprehensive distribution of the vaccine that reaches into rural communities and will include working with community pharmacies as important distributors. However, be under no illusion: our priority is speed and reach, which is why the deployment has taken the shape it has.

[Lord Lancaster of Kimbolton (Con)]

My Lords, my noble friend Lord Blencathra hits the nail on the head. I add my thanks for the support of the military—my noble friend the Minister will forgive me if I sound like a pedant, but it is not just the Army but also the Royal Navy and the Royal Air Force. However, their support is ultimately unsustainable. Yesterday the Defence Secretary suggested that the NHS should create a reserve of its own. We are certainly not short of volunteers, given the response to the call to arms last year, so is the Minister considering it?

[Lord Bethell (Con)]

My Lords, my noble friend rightly picks me up on my use of words. I profoundly thank all those in the armed services who have made a contribution. They bring particular qualities to such a challenge as the deployment of the vaccine: logistical analysis and project management of the highest level, and the manpower and ability to get things done quickly on the front line. Those are extremely complementary. However, be under no illusion; there are 1.3 million employees in the NHS, and far fewer in the Armed Forces. There is no question of the Armed Forces being able either to replicate or take the role of the NHS in such a large project, though we are enormously grateful for their particular contribution. One lesson of the pandemic has been the remarkable return to work of former NHS workers and the early graduation of some trainees. We should and will look at the use of volunteers in the NHS in months to come.

[Lord Loomba (CB) [V]]

My Lords, the Government’s action plan for the rollout of the vaccine is commendable, with over 2.5 million doses given to date. One issue now appearing is that there are a good many no-shows at vaccine hubs. In an effort not to waste the vaccine, which has a short shelf life, administrators are finding as many people in close proximity as possible to give the unused doses to. While not wasting valuable doses is admirable, does the Minister agree that some back-up system should be in place to ensure that those who need it most are able to get it first when there are so many no-shows daily? Secondly, does he agree that parliamentarians in both Houses should be on a priority list for vaccination?

[Lord Bethell (Con)]

My Lords, no-shows are being managed extremely effectively under the current arrangements. We are extremely grateful to the British public for their perseverance.

[Lord Faulkner of Worcester (Lab)]

My Lords, I am happy to join others in congratulating the Minister on how he has delivered news about the vaccines to your Lordships’ House and to everybody concerned with the rollout. I wish it well in every possible respect. However, I am sure he will agree that, as it will take a little while before the vaccine has the beneficial consequences we want, it is essential that we do not drop our guard now. In that context, I return to a subject I asked him about two weeks ago: the mandatory wearing of face coverings. I asked him then what guidance the Government could give to public-spirited people who try to encourage others who are not wearing face masks in places such as shops and on public transport about whether they are right to do so? Can he give some comfort to those of us who want to intervene but are frankly deterred by the reaction we are likely to get? It is good news that the supermarkets are operating a new policy, and I welcome the announcement by the Metropolitan Police Commissioner. I would like a bit of a lead from the Government as well.

[Lord Bethell (Con)]

The noble Lord is entirely right. The advent of the new variant, with its extremely high transmissibility, means that we all have to rethink our approach to the pandemic. We must all adopt habits that are uncomfortable and frustrating, of which mask-wearing is one good example. I know that colleagues in government are looking at ways in which restrictions should be refined. The Government do not take a view on intervening with members of the public; it is the personal responsibility of individuals to make decisions for themselves. The police certainly have very clear guidance on what interventions they should make, and it is best to leave it to them.

[Baroness Jolly (LD) [V]]

My Lords, the scale of this rollout is truly impressive, and I join others in congratulating all those who have actually made it work in such a short time span. I live in a very rural area on the edge of Bodmin Moor. My local satellite surgery has closed because it cannot be made Covid secure, and the vaccination site is 18 miles away with no public transport connections. Would it be possible for older people who cannot get to the vaccination site to be vaccinated by a different practice, which is only five miles away by bus but in the other direction?

[Lord Bethell (Con)]

The short answer is yes, and absolutely. The noble Baroness makes a point that we understand vividly and extremely well. Many smaller GP surgeries simply are not physically capable of being Covid secure, as she rightly points out. We are taking a panoptic view of health records to ensure that the right GP surgeries which are open can offer the service to those who would not normally be reached.

[Lord Fairfax of Cameron (Con) [V]]

My Lords, I would like to ask my noble friend the Minister two questions, if I may. Like many others, I first congratulate him and the Government on the progress made so far with the vaccination programme. But what plans do they have to further turbo-charge the vaccine deployment programme? I am, of course, thinking of a 24/7 vaccine centre, as many others have referred to already. Reference has also been made to Israel’s much greater progress, so far. But is the Minister aware of the comment of the highly respected Professor Bell of Oxford, who said that we could vaccinate the whole country “in five days” if we had the will, subject, of course, to supplies of the vaccine? Professor Bell went on to say that this vaccine rollout is a “war” and should be treated as such by the Government. Therefore—in my respectful submission—to refer to consumer demand is not necessarily consistent with that status of war. On my second question, the Government have said that they expect all nine high-risk groups to be vaccinated “by the spring”. Can the Minister tell us what exactly the Government mean by the spring—in other words, months and days or dates?

[Lord Bethell (Con)]

My Lords, on turbo-charging the vaccine deployment, the two key focuses are: first, on very large centres, which can have a very large throughput of people, as these will make an enormous difference and bring an industrial energy to the process; and, secondly, to extend the reach into the hard-to-reach communities, whether those are rural or where people are not in the mainstream of British life. Regarding the noble Lord’s point on the “war”, while it might seem obvious to him that everyone will step forward for the vaccine that is not, strictly speaking, right. Some people are going to make careful decisions before stepping forward to have it, so we have to think about making it attractive and reasonable to as many people as possible, particularly those who are vulnerable to the disease. I do not think it is right that we cannot have a consumer mentality to this. We have to treat the public with consideration and thoughtfulness, because they will decide whether they are going to step forward or not.

[The Deputy Speaker (Baroness Morris of Bolton) (Con)]

I now call the noble Baroness, Lady Meacher. Lady Meacher?

[Baroness Meacher (CB) [V]]

Sorry, I could not get myself unmuted. My Lords, as a Covid sufferer, which I am, I too applaud the Government’s amazing vaccination programme. I just have a few points of clarification. First, when the Government talk about offering a vaccination to all four top vulnerability groups by mid-February, do they mean all those groups will have a vaccination by mid-February or an invitation for one, which, of course, could be for a vaccination in March or April? Secondly, is there any progress yet on bringing forward the second vaccination—we are talking about the country here—from the 12-week point, bearing in mind the greater risk of mutations while we have this rather long wait between first and second vaccinations? Thirdly, if I may, can the Minister contradict the anti-vax story, which I regard as very dangerous, that the vaccinations contain polyethylene glycol which could be dangerous for allergic people? These stories just have to be crushed, if we can.

[Lord Bethell (Con)]

My Lords, the four priority groups that the noble Baroness alludes to are: care home residents; residential care workers; the 80-plus; healthcare workers; social care workers; 75 to 79 year-olds; 70 to 74 year-olds; and the clinically extremely vulnerable. It is a huge proportion of those who are most vulnerable to the disease. We can only offer people a vaccine; we cannot force them to have it. Certainly they will be offered it, but the encouraging news is that a very large proportion of people seem to be stepping forward, and attitudes towards the vaccine so far seem to be extremely positive. I reassure all those who have seen anti-vax messages that this is not something that those with allergies should be frightened of. On the second dose, the MHRA has been clear that there is no evidence that the current round of mutations we have seen has any impact on the vaccine, and that it in no way increases the need for an accelerated second dose.

[Viscount Younger of Leckie (Con)]

My Lords, I would urge speakers to keep their questions short—one question, please—to allow all speakers to contribute.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, based on the scientific and medical evidence, which undoubtedly will be gathered throughout this vaccination process, can the Minister indicate if there will be annual rollouts of the vaccination programme from 2022 onwards?

[Lord Bethell (Con)]

My Lords, I cannot look into the future with that much clarity, but the noble Baroness raises a possibility that surely must be accounted for. It is possible that this kind of coronavirus may mutate; it may need to be managed, as we do other flus. It is too early to make that call but that is the kind of thinking that goes into the development of the NIHP—the new National Institute for Health Protection.

[Lord Rooker (Lab) [V]]

My Lords, I declare an interest as someone who is shielding. I too congratulate everybody involved in the vaccine project. The Minister alluded to the targets; I have to assume that we are going to vaccinate 350,000 today, so that we can maintain the target. That is really important. On the rural aspect, I live in Shropshire. Those who run Shropshire live in the north and tend to forget south Shropshire, so the issue of rural vaccination is pretty crucial. But can I make one final point relating to the point that my noble friend Lord Winston raised earlier on? I am in a position to ask the Minister a question today only because I gave my informed consent on three or four occasions in the last 12 months. I did not look on that as a specific performance contract by the NHS; I looked on it as allowing the NHS to do things to my body to help me survive. If they come along and change their opinion about the way they want you to survive, we should go along with their advice.

[Lord Bethell (Con)]

The noble Lord makes the point extremely well, and I agree.

[Baroness Sheehan (LD) [V]]

My Lords, no one is safe until everyone is safe. Does the Minister agree? If so, what thought have the Government given to supporting the temporary TRIPS waiver proposal by South Africa and India, given that it will help the WHO’s efforts to co-ordinate the local supply of vaccines through its C-TAP initiative?

[Lord Bethell (Con)]

My Lords, I would put the truism slightly differently: the vaccine makes you pretty safe, but it does not mean you are not dangerous to other people. I think we all have to get used to that. Regarding the South African variant and the other variants popping up in Brazil and elsewhere, this is a manifestly different disease that is growing up around the world. It has a huge implication for international travel. We are working with the WHO and other groups to try to understand this, but it is certainly of grave concern to the country.

[Lord Farmer (Con)]

My Lords, I join many others in applauding the Minister and the Government on their vaccination energy and foresight, and for being leaders in the world, frankly. Given the Minister’s zeal and energy, he informed the House on 30 November that the SIREN and Oxford healthcare workers studies would report on the level of sterilising immunity provided by natural infection before the end of 2020. Have they concluded that antibody protection can be relied upon for at least six months after infection, or longer, and what are the implications for herd immunity?

[Lord Bethell (Con)]

My Lords, the SIREN study is an important study on antibody protection. My understanding is that it is due to be published very soon indeed, and when it is, I will be glad to share the insight with my noble friend.

[Lord Walney (Non-Afl)]

Further to the question from the noble Baroness, Lady Richie, the Minister told your Lordships’ House yesterday that was there was a very real threat that a variant could start escaping the vaccine. In those circumstances, could there not be a need for a massive standing vaccination programme, far beyond the national flu jab scheme, and are the Government therefore making contingency plans for such a challenge?

[Lord Bethell (Con)]

That is a gruesome prospect and not one that I like to see in a debate like today’s, where there is so much positivity. However, the noble Lord is entirely right that mutations may go that way. The good news is that the current round of mutations that have been seen in Kent, South Africa and Brazil seem to be about transmissibility, not escapology. It is as though the car had driven into the pits and had a turbo attached to it, but not camouflage equipment. But that could happen, and if it did, we would indeed have to look at much more emphatic and systematic long-term vaccination programme.

[Baroness Altmann (Con) [V]]

My Lords, I too congratulate the Government and the Minister on all the tremendous work that has been done, especially on the vaccine. Can he say what the hold-up would be for a 24/7 programme, what the scale of supply is, and when a supply chain might be available that could deliver 24/7 vaccination? The scale of damage to other aspects of the health of our nation as well as to the economy is unsustainable. This is like a war effort but we absolutely need to be rolling out this vaccine as quickly as we possibly can.

[Lord Bethell (Con)]

My Lords, I completely hear my noble friend’s encouragement, and her advocacy on behalf of business and a return to normal is heard loud and clear. The deployment is happening literally as quickly as we can possibly make it. I suggest to her that even NHS workers have to sleep, they have families, and it is not possible to run operations through the night on a mass scale. You cannot force people to turn up for a vaccine. I am not sure that the idea that millions of people will turn up at 4 o’clock in the morning for a vaccine is entirely realistic. However, my noble friend’s point about scale and whether we can move faster and turn around the situation more quickly is extremely well made. I reassure her that we are doing everything we possibly can.

[Baroness McIntosh of Pickering (Con) [V]]

Will my noble friend join me in congratulating dispensing GPs in rural areas on hitting the main target group of over 80 year-olds? Can he confirm that the latest spike in care homes may be attributable to the fact that a second dose is not being administered within 21 days? Will he revert to that practice as far as possible and ensure that the same vaccine is given for the second dose?

[Lord Bethell (Con)]

I pay tribute to the role of dispensing GPs, who will play an incredibly important role in the rollout. However, I reject the suggestion that any spike in care homes is in any way related to decisions on the second dose. The new variant has spread throughout society, including care homes, and that is the explanation for the spike.

[Baroness Bennett of Manor Castle (GP) [V]]

Can the Minister assure the House that the Government have a co-ordinated plan involving not just vaccination but improved test, trace, self-isolate and support, and flexing controls on commercial and social activity to reduce and control the levels of the virus over the coming weeks and months? Can he tell us when the Government plan to publish such a plan? Obviously, events will have an impact, but now that we have had a year of learning about the virus, surely the Government have an overall vision of how we as a nation will emerge from the pandemic, and it would help us all if that was shared with the nation.

[Lord Bethell (Con)]

The noble Baroness is right that we have the vaccine today but that does not mean that we will not need to be testing, distancing and washing tomorrow. In fact, there will be a very large number of people—tens of millions—who will not be vaccinated through the summer but who could still catch the disease. We have to make provisions for our public health to protect those people in the workplace, in society and in their homes. The plan is very clear—it is the plan that we have already. However, the noble Baroness is right that we have to be focused on it and ensure it is kept up to date and deployed with energy and enthusiasm.

[Lord Randall of Uxbridge (Con) [V]]

I thank my noble friend for his assiduous and clear briefing to the House. Can he thank those who have already delivered vaccines to our overseas territories? Perhaps in due course he can let me have details of what has been delivered to individual OTs and the plans for the coming weeks.

--- Later in debate ---

[Lord Bethell (Con)]

I pay tribute to colleagues in the FCDO, which has been a tremendous advocate for overseas territories. We have made considerable provisions to ensure that vaccine supplies are provided to the far-flung territories, where we have strong relationships and a duty of care. I would be glad to write to him with the details of that deployment.

[Baroness Uddin (Non-Afl)]

My Lords, anyone questioning the horror of the disease and the pressures on the NHS need look no further than outside their local hospitals, as I did, notwithstanding that questions on efficacy, information and choices are the fundamental right of every patient. The Minister will know that the Bangladeshi community has a very high vaccination compliance rate, but in this case there has been quite a lot of confusion. Can he yet again confirm that sufficient bilingual material is being made available to the community, and will he agree to meet with me and some experts on this issue?

[Lord Bethell (Con)]

My Lords, that is a very good reminder. I will be glad to return to the department and check that the bilingual material is as she asks, and I will write to her with the details.

[Lord Mann (Non-Afl) [V]]

My Lords, the NHS has been put in charge of this and is delivering big time, and everyone I speak to is delighted about the way the rollout is going. When we move into the next phase, will workplaces be targeted, so that they are able to do their own logistics and get thousands done at a time, quickly, cheaply and easily?

[Lord Bethell (Con)]

My Lords, that is a decision for the NHS deployment team. I do not know the precise answer but frankly, based on experience I would guess that NHS environments are probably the focus for the deployment—that the focus is on where NHS staff can have safe, hygienic environments, rather than on workplaces. However, I will take the noble Lord’s idea back to the department and write to him to see whether that is being considered.

[The Deputy Speaker (Baroness Morris of Bolton) (Con)]

My Lords, all questions have been asked.

Covid-19: Vaccine

Lord Bethell Excerpts

Tuesday 12th January 2021 Lords Chamber

[Baroness Deech]

To ask Her Majesty’s Government what evidence they have that delaying a second dose of the Pfizer-BioNTech Covid-19 vaccine will not (1) diminish its effectiveness, or (2) cause further mutations in the virus.

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

My Lords, the views of the MHRA and the JCVI, based on the data submitted from extensive clinical trials, is very clear: a single dose gives very high protection from the virus 10 days after the first dose. A second vaccine dose is important to sustain that protection and extend its duration. Of course, it makes sense to vaccinate as many people as possible as quickly as possible to protect their lives and safeguard the NHS, which is why we take the approach that we have.

[Baroness Deech (CB) [V]]

My Lords, today we are discussing the safety of medicines. Only moments ago, the Minister was emphasising just how important that is. Yet in delaying a second dose, the whole country is being treated as an experiment. Pfizer has said that the trial of the vaccine was on participants who received a second dose within three to four weeks. There is no data, it said, to demonstrate that protection after the first dose is sustained after 21 days. The WHO also says that there is no scientific evidence supporting the delay beyond six weeks. No other country is doing it. The UK is taking a gamble that risks fostering vaccine-resistant forms of the virus. Will the Minister mitigate the risks and ensure that a second dose is given at 21 days, until there is independent scientific advice and evidence for the delay?

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I remind the noble Baroness that Pfizer is not a regulator, nor is the WHO. Other countries are working on vaccines, but they are behind the UK in terms of authorisation and rollout. I reassure her that there is data, which is published on the internet. I tweeted a copy of it late last night, and I invite her to have a good, close look at it because it is absolutely categoric: one dose is enough.

[Lord Campbell-Savours (Lab) [V]]

There is a heated debate going on in the United States, as reported on CNN, over the incidence in use and registration of both the first and necessary second vaccinations with particular concern over the second, without which the first is less effective, despite what the Minister has just said. What plans do the Government have in the United Kingdom to ensure compliance with the necessary take-up of the second vaccination and the registration of both by the authorities?

[Lord Bethell (Con)]

The noble Lord is entirely right: the second dose is important. However, it is important not for efficacy but for durability. We have put in substantial data provisions to record every single dose into every single arm, and to put a follow-up dose into exactly those arms. We are using the NIMS system and every single vaccination is put into the GP record. They will be tracked down extremely diligently for exactly the reasons that the noble Lord describes.

[Baroness Brinton (LD) [V]]

My Lords, a number of scientists have expressed concerns about delaying the second dose of the Pfizer/BioNTech Covid vaccine. On the excellent Radio 4 programme “How to Vaccinate the World”, Professor Sir David Spiegelhalter said that, as the RNA technology used is new, there is less data to give confidence on spacing. But he suggested that, given a number of people have received their first dose, now is the perfect time to do a small randomised research trial on comparing those receiving their second dose at 21 days and others receiving it at 12 weeks, which would then perhaps give more confidence. Is that happening?

[Lord Bethell (Con)]

Who can hold a torch to Professor Spiegelhalter and his analysis of the data? Although I did not hear him, I completely welcome his comments. I reassure the noble Baroness that enormous efforts are being put into the pharmacovigilance around this vaccine. Some of this is of a clinical and scientific nature, and it takes a while to read out. We have therefore put in parallel systems to get an early read-out on exactly the kinds of questions that she has asked.

[Viscount Eccles (Con)]

My Lords, as an interest, I can report that Lady Eccles and I have both had two Pfizer jabs, three weeks apart. At the planned rate of 2 million vaccinations a week, there will be the equivalent of 1 million people being fully vaccinated, whatever the gap. There will also be a continuing critical path through this rollout, which is complex. It may start by being vaccines, which are the limiting factor, but it could become otherwise. Can we be assured by my noble friend that the NHS is fully prepared to identify and deal with the critical path? Can we also be assured that we will get clear and full information on progress, and about the actions being taken to maintain that progress?

[Lord Bethell (Con)]

I congratulate my noble friend and Lady Eccles on their double vaccinations. It is one of the most heartening experiences of a pretty dreadful year to witness the rollout of this vaccination and the joy and reassurance it brings to those who have been vaccinated. I reassure my noble friend that the NHS is absolutely putting the resources in place not only to roll out the single and second vaccinations to everyone over 18 who will step up for those but also for the pharmacovigilance to ensure that any adverse effects are recorded through the Yellow Card scheme and that those records are analysed and acted upon so that any changes or tweaks, as sometimes happen, are enacted by the NHS to get the best possible outcome for as many people as possible.

[Baroness Hayman (CB) [V]]

My Lords, may I ask the Minister another question about evidence? When do the Government expect to have clear advice on the possible transmission risk from those who have been vaccinated? Everyone I know who has received the vaccine—they have been delighted to do so and impressed by the efficiency of the NHS—is now talking about meeting their Pfizered friends, seeing grandchildren and returning to volunteering or to your Lordships’ House. Does the Minister acknowledge that there will need to be cogent and clearly communicated advice for those who have been vaccinated, many of whom have been in virtual isolation for nearly a year?

[Lord Bethell (Con)]

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

[Baroness Thornton (Lab)]

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

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[Lord Bethell (Con)]

The noble Baroness is right that communication is key. We seek to explain the scientific basis of this vaccine, and a huge amount of effort has gone into what I call “O-level biology communications.” This is one of the reasons why acceptance rates appear to be—touch wood—as high as they are at nearly 90%. Had someone told me that number a few months ago, I would have happily settled for it. She is right, the escapology of this virus is just the same as it is under AMR. From very early analysis it would appear—and this is extremely conditional—that the recent variant is not escaping the vaccine or any of the therapeutics we have put in place. However, it is more performance enhancing. That is good news for the vaccine and bad news for the prospect of having a disease present in society and the world for some time to come.

[Lord Roberts of Llandudno (LD) [V]]

My Lords, this virus is unchartered hostile territory and we can but rely on the best scientific advice. Some will say that delaying the second jab might even be advantageous and others will disagree. By delaying, debating and disagreeing we are going to put many thousands of lives at risk, lives which could have been saved by having that first jab. I am not qualified to say which is the best; I wish I was. I can only in gratitude accept the guidance of experts and that is what I will do. In doing so, I think that hundreds or thousands of extra lives will be saved by that first jab.

[Lord Bethell (Con)]

The noble Lord alludes to a complicated dilemma that we all feel. I welcome challenge and those who query and question the basis of our policy decisions and our science. He is right: too much false information and fake news can damage trust. We have gone about the vaccine process with an approach that is as open and transparent as it can possibly be. We have sought to engage in dialogue and answer questions where there have been any. That approach has proved to be effective and it is the one we continue with.

[Baroness Browning (Con) [V]]

My husband, who is 84 years old, received his Pfizer vaccine before Christmas and his second one last week was cancelled. Is there any guarantee that, when the second jab comes, it will be the Pfizer vaccine? As I understand, there has been no research on mixing and matching these vaccines. Is there any way that the level of immunity can be tested at that three-month point?

[Lord Bethell (Con)]

The CMO has made it clear that he leans heavily towards having consistent vaccines, but it is not a requirement. Some of the immune response comes from antibodies which can be tested, but some of it is from T-cells, which are very difficult to test for. It is not possible to categorically say whether someone is immune. However, we have looked at ways to measure and understand more about the body’s immune response to develop our understanding in this area.

[Baroness Masham of Ilton (CB) [V]]

My Lords, what is the chance that, if the second Pfizer vaccine dose is delayed, the virus could become resistant to the vaccine? For what reason do Pfizer and the World Health Organization recommend three weeks between the vaccines?

[Lord Bethell (Con)]

The noble Baroness is right; this virus could mutate and start escaping the vaccine. That is a very real threat. The good news is that we know so much about it now, have digitally mapped it and have grown it so many times in the laboratory, that making new vaccines would be a relatively straight- forward process. It would not necessarily require the months of clinical trials that the first one did. However, be under no illusion, were this to happen it would set our vaccine deployment back considerably.

[Baroness Pidding (Con) [V]]

My Lords, I appreciate the necessity of getting as many people vaccinated as possible and the need therefore to be agile and flexible in making policy decisions. However, would the Minister agree with me and other Lords that it is also critical we win the battle of communications? We need to ensure that we take the public with us, with a clear understanding and a clarity of message.

[Lord Bethell (Con)]

The central proposition we are discussing is that it is better to double the number of people getting their first jab, even if there is a marginal decrease in the efficacy of the vaccine for a few people. That message has got through to the public and I think it enjoys tremendous public support. I acknowledge the concern that some will naturally feel about what appears to be a diminution in provision, but I am here to reassure and provide consistent scientific advice that is not the case.

[Lord Vaux of Harrowden (CB) [V]]

My Lords, two logistical questions are raised by delaying second doses. First, given AstraZeneca’s statement yesterday about variability of manufacture, together with the increasing global demand going forward, how will the Government guarantee we have enough vaccines of the right type for all second doses at 12 weeks? Secondly, am I right that from the end of March the rate of new vaccinations will fall sharply, because we will then need 2 million doses per week just to cover the second doses?

[Lord Bethell (Con)]

I think the noble Lord has read too much into the AstraZeneca statement. Negotiations with AstraZeneca and provisions in manufacturing capacity are extremely well advanced. All the projections in the vaccine plan published yesterday have been bottomed out and secured with manufacturers and deployment. The Secretary of State was very clear about the objectives of 13.6 million by the end of February and the whole country by the autumn. Those are not vague reassurances; those are bottomed out and have business plans behind them.

[The Deputy Speaker (Baroness Garden of Frognal) (LD)]

My Lords, the time allowed for this Private Notice Question has elapsed. I apologise to the noble Baronesses, Lady Uddin and Lady Gardner of Parkes, that there was not time to take their questions.

Medicines and Medical Devices Bill

Lord Bethell Excerpts

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

Moved by

[Lord Bethell]

1: Before Clause 1, insert the following new Clause—
“PART A1THE COMMISSIONER FOR PATIENT SAFETYEstablishment and core duties etc
(1) The Secretary of State must appoint a Commissioner for Patient Safety (referred to in this Part as “the Commissioner”) to exercise the functions set out in this Part in relation to England.(2) The Commissioner’s core duties are to—(a) promote the safety of patients with regard to the use of medicines and medical devices, and(b) promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.(3) The Commissioner is not to be regarded as the servant or agent of the Crown or as enjoying any status, immunity or privilege of the Crown.(4) Schedule (Further provision about the Commissioner for Patient Safety) makes further provision about the Commissioner.”Member’s explanatory statement
This amendment inserts a new Clause which provides for the creation and core duties of a Commissioner for Patient Safety in relation to medicines and medical devices in England. The new Clause and the Schedule which it introduces would form a new Part, to appear before Part 1.

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

My Lords, patient safety is very much at the heart of the Bill, and while we have an enormous amount to get through this afternoon, I beg the Chamber’s forbearance if I talk in some detail about this extremely important amendment. Patient safety is the golden thread that runs through this entire Bill. Safety has been our guiding force in amendments that have made it to the Bill, from the changes to decision-making on regulatory change and the new safety lock amendment—which we will debate later—to the enforcement powers for medical devices to make clearer what the MHRA can do to take action, through to the medical devices information system.

The Government have heard the calls, including the strong cross-party support, to establish an independent patient safety commissioner for the health service in England. Of course, this was the centrepiece recommendation of the Independent Medicines and Medical Devices Safety Review helmed by my noble friend Lady Cumberlege, to whom I pay profound tribute for her tireless championing on behalf of patients. I am delighted that Amendment 1 in my name—with which it is convenient to debate Amendments 54, 65, 70 to 72, 74, 86, 87, 91, 95 and 97—delivered upon that recommendation. These amendments provide for an independent advocate to champion the safety of patients. The patient safety commissioner will promote their interests and those of other members of the public in relation to the safety of medicines and medical devices.

We acknowledge that the patient’s voice can advance safe care and system improvements but that it needs to be strengthened, as explained in my noble friend’s review published six months ago. Listening to patients is central to preventing the kinds of issues which that review brought so clearly into focus. If we do not strive to listen to patients, their families and to staff, we limit our ability to learn from mistakes, be innovative and continually improve. I pay testament to the extensive listening and the passionate advocating by my noble friend, her supporters and all patient groups.

Patient safety is a system-wide concern. It cannot be tackled by a single individual but needs to be rooted in all the branches of our health system. Good progress has been made: for example, we are improving system-wide learning through measures such as the Healthcare Safety Investigation Branch and the implementation of the 2019 NHS Patient Safety Strategy with our National Director of Patient Safety, Dr Aidan Fowler, in charge. That strategy has been listening to patients.

Staff are also encouraged and protected to speak up if they have concerns about anything they believe is harming the services their organisations deliver or commission. They are supported by the NHS People Plan, which envisages a health service that is compassionate and inclusive, not hierarchical, and where staff are listened to. The Government’s emphasis on patient safety will also be reinforced by the establishment of a new patient safety programme board. The board will take an overview—with pace and rigour—of measures and actions across the health system to improve patient safety.

The Government fully support sharpening our focus on the safety of NHS-funded services to patients and the public. We accept that the patient safety system needs to get better at identifying issues and listening to patients’ experiences of avoidable harm. Better co-ordination across and between regulators and other oversight bodies is also needed.

A patient safety commissioner will help us to champion the views of people who have been harmed by treatments provided by the health service. He or she would reinforce a culture of humility, openness and learning. The role is essentially about prioritising the insights of patients as a vital source of learning.

The Government’s amendment puts this new part of the Bill first. Amendment 1 provides for the appointment by the Secretary of State of a patient safety commissioner who is an independent statutory officeholder funded by the Department of Health and Social Care. It sets out the commissioner’s core duties, which are to promote both the safety of patients and the importance of ensuring that they are heard.

Patient engagement will be integral to the role of the commissioner. Proposed new Schedule A1 outlines the ways in which the commissioner must inform, consult and involve patients. This will ensure that patients’ concerns are being heard and that the work of the commissioner has focus and relevance for the people he or she is being set up to serve.

We have reflected carefully on the patient safety commissioner model set out by my noble friend’s comprehensive report. We agree on the importance of the commissioner’s role; it is a critical new part of the map of patient safety. But there are other areas of significant importance to the Government. The commissioner is one part of the whole system—the fundamental change that it required to tackle unsafe care and empower patients. A step change is required in how the health service transforms itself in a joined-up way to put patient safety at its core. Significantly, the introduction of the commissioner should not create overlap or confusion within that health service architecture, thereby reducing the potential to deliver patient safety improvements for patients. Indeed, my noble friend’s report rightly made it clear that the duplication of the roles of other regulatory bodies should be avoided.

In view of this, the patient safety commissioner will not act as an ombudsman. He or she will not carry out functions in pursuit of specific cases. But they can consider individual cases in their role as an overarching advocate for all patients and of making thematic and systemic recommendations. These areas are where we believe the commissioner can have greatest impact.

We have also given the patient safety commissioner deliberately intrusive powers, as called for by my noble friend Lady Cumberlege. He or she will be empowered to request and share information from relevant public authorities or a “relevant person”, meaning anyone providing health care, in relation to medicines and medical devices in England. The commissioner’s ambit will cover both the public and the independent sector.

Where my noble friend and I differ is on the process of the appointment and sponsorship of the commissioner. The patient safety commissioner will be appointed by the Secretary of State for Health and Social Care and funded by the Department of Health and Social Care. It is absolutely right that this should be the case. For example, the Secretary of State is able to initiate action on reports and understands, and has strategic oversight of, the system the commissioner is looking at.

Some noble Lords have expressed concerns about how such a commissioner might maintain their independence, but I believe that such concerns are unfounded. I am encouraged by the precedent of the Office of the Children’s Commissioner, which drew praise from several noble Lords in Grand Committee for its independence. As noble Lords know, the Children’s Commissioner is sponsored by the Department for Education and guards its independence very well. The Victims’ Commissioner does exactly the same and is sponsored by the Ministry of Justice.

It is critical—that is agreed—that the patient safety commissioner is able to speak out without fear or favour. He or she must have the powers and functions to act independently to maximise their impact and confidence. That is absolutely the case here. It is also critical that the right calibre individual with a strong voice for patients is appointed to the role. I do not think any such person would accept such a role if they felt they would in any way be constrained in that role. Nor do I think they would remain silent. Furthermore, we would expect the Secretary of State to work with the commissioner to establish how they will safe- guard and secure the commissioner’s independence. Independence is not static but an active objective, which we would expect the patient safety commissioner to be prepared to approach continuously.

The commissioner will have the power to make reports to both the public sector and independent sector, and to the Department of Health and Social Care if they so wish. Those reports are entirely independent. There is no intention—and indeed no restriction—that would allow for the Secretary of State to edit those reports. As an independent public appointee, the commissioner will also be subject to the scrutiny of Parliament, including through the Health and Social Care Select Committee.

The powers in the Bill are accompanied by a regulation-making power about the terms of office of the patient safety commissioner, the appointment of staff, and other operational matters. But while this power is exercised by the Secretary of State, we are not proposing that the Secretary of State would have any power over the commissioner regarding the fulfilment of his or her functions. However, it is right that the detail is left to regulations so that we can publicly consult on this, as we are obliged to do so under Clause 45. It is important that we get the details right. That is also why the regulations will be subject to the draft affirmative procedure.

Other amendments make minor changes to ensure that the patient safety commissioner clauses work well with the rest of the Bill.

From the First Do No Harm report by my noble friend Lady Cumberlege, to earlier, well-known inquiries and investigations, we have heard numerous harrowing stories with terrible examples of how patients have been let down badly by our most loved institutions. As noble Lords have said, now is the time to act. The Government have listened to the impassioned and compelling arguments from all sides, and I thank my esteemed colleagues for their help in shaping this amendment.

We have no doubt that restoring patient trust will be at the heart of the patient safety commissioner’s role and that he or she will advance patient safety. Our commitment to amplifying and acting on the voices of patients in our health service is paramount. To that end, I beg to move.

[Baroness Cumberlege (Con) [V]]

My Lords, I thank the Minister for his huge support throughout this whole process—all the times we have had to meet and I have met with his officials. I also thank him for the way in which he has so comprehensively introduced his amendment today. To be honest—“O ye of little faith!”—there were times when I thought the patient safety commissioner would not see the light of day. However, I underestimated my noble friend and thank him for agreeing to the concept and for bringing it to fruition with his officials.

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[Baroness Thornton (Lab)]

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

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

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

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

[Lord Bethell (Con)]

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

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

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

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

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

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

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

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

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

“any other person the Commissioner thinks appropriate”.

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

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[Baroness Cumberlege (Con) [V]]

My Lords, I want to say one or two things very quickly. I thank those who have spoken; it has meant such a lot to me. The noble Baroness, Lady Jolly, and the noble Lords, Lord Patel and Lord Hunt, have been there since the very beginning of this journey.

I say to the Minister, as I should have said at the very beginning, that I will withdraw my amendment. I have no wish to take it further. I do think that the Cabinet Office would have provided us with more independence, but my noble friend the Minister said at the very beginning that this was a red line and it was no good my pursuing it. I took that hint and I have not argued it anywhere. Hearing the Minister talk about independence today—getting it on the record—has been really important. However, as the noble Lord, Lord Lansley, said, of course influence matters as well, and I take that.

I will say a very quick word about the timetable, which is critical. In our recommendations we wanted to set up a task force to implement this under the aegis of the Department of Health and Social Care. That has been rejected by Ministers. That is a tremendous pity. Noble Peers are concerned about the timetable; so am I.

It has been said that this has been very quick. No, it has not. Those of us who have run companies know what “quick” means: if your company is to survive you have to act very quickly. This is not quick. I will put pressure on through other means, particularly the all-party group, to get this implemented as soon as possible, because people are suffering. People are in dire straits and we have to stop this awful damage that is being done to lives. The quicker we can do this, the better. I am sure my noble friend will agree with that.

I know when I am beaten, but I also know what needs to be done. I do not want to go through the point of view of the Cabinet Office, but it is absolutely critical that this appointment is made speedily, because people are suffering and we should avoid that if at all possible. I believe that the patient safety commissioner will grasp this issue and ensure safety, which, as my noble friend the Minister said, has run through the Bill. I thank him for that, but it will not happen until this appointment is made. I am afraid that I will press very strongly on that.

I thank all noble Lords for taking part. I wish I could go through this in detail, but it is not my remit to do so. I thank noble Lords so much for their support.

[Lord Bethell (Con)]

I thank my noble friend for her very kind and generous words, and for making it clear that she will not move her amendment. I reassure all noble Lords that their words are on record and will have a bearing and influence on the development of the patient safety commissioner as it is rolled out.

My noble friend’s question was about timing and speed. I hear her admonishments loud and clear. She knows that once we have committed to something we will deliver it. I ask for her forbearance. There is a global pandemic on. I cannot guarantee that this is the number one priority because we need to do the vaccine and we have to get Britain back on its feet. Those are distractions that I cannot hide from the House, but I reassure my noble friend and all those involved in the debate that a commitment has been made very clearly and we are now moving to deliver it.

Amendment 1 agreed.

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[Baroness Jolly (LD) [V]]

As the noble Lord, Lord Hunt of Kings Heath, and others have said, these amendments relate to sunset provisions and consolidated legislation. As we have already heard, the Bill is largely a skeleton Bill and allows the Secretary of State or a relevant authority to make legislation by statutory instrument on policy issues relating to human medicines, veterinary medicines and medical devices. Can the Minister confirm whether the SIs referred to will come before the House? Will he also confirm that the SIs we see will live up to the expectations of the noble Lord, Lord Blencathra, and his committee?

It is important that there is a limit on how long the delegated powers should last. The amendments in the name of the noble Baroness, Lady Thornton, would mean that, after the suggested three years have elapsed, the policy objectives of the Government would be clearer and they could return with primary legislation. The amendments in the name of the noble Lord, Lord Patel, would require the Government to publish the consolidated primary legislation in draft form. We support these measures but, for the intervening period, we believe that the powers should be subject to the additional scrutiny required by my noble friend Lord Sharkey’s amendments in the next group.

[Lord Bethell (Con)]

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

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

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

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

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

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

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

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

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

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

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

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

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

[Baroness Thornton (Lab)]

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

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

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

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

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[Baroness Thornton (Lab)]

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

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

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

[Lord Bethell (Con)]

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

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Moved by

[Lord Bethell]

4: Clause 1, page 1, line 9, leave out subsection (2) and insert—
“(2) In making regulations under subsection (1), the appropriate authority’s overarching objective must be safeguarding public health.”Member’s explanatory statement
This amendment provides that the appropriate authority’s overarching objective in making regulations under Clause 1 must be safeguarding public health.

[Lord Bethell (Con)]

My Lords, one of the key qualities of this place is bringing to bear years of expertise in refining legislation. From those involved in life sciences to ex-Health Ministers, we have between us cumulative decades of experience. In moving this amendment, it may be convenient if I speak also to Amendments 6, 8, 9, 11, 29, 30 to 33, 42 to 45 and 47.

I am very grateful to all noble Lords who spoke at Second Reading, who have written, who have met with me and who spoke in Grand Committee on the fundamental points that we are discussing now through Amendment 4: how we ensure that we have the powers needed to make regulatory changes to the bodies of law that govern medicines and medical devices; how we ensure that the changes are swift and safe, and support the continued availability of medicines and devices; how we ensure that essential changes are practicable in a fast-paced environment; and how we provide confidence in the checks and balances built into the framework in which these powers can be exercised.

The amendments that I have tabled are the result of detailed talks. I pay tribute in particular to my noble friend Lord Lansley, the noble and learned Lord, Lord Woolf, and the noble Baroness, Lady Thornton. Their amendments in Grand Committee can be seen as the seeds from which my amendments have grown. I say “my amendments” but I view them as a collective effort—an evolution from our discussions in Grand Committee and refined through cross-party conversation. I will come to and address the noble Baroness’s amendments to my amendments, where I hope I can provide further assurances.

As I have said before, this Bill is a framework Bill. It is so because we must have powers that allow us to work with the comprehensive and established regulatory regimes that already exist. We must also have the means to respond effectively, swiftly and appropriately to questions asked. My noble friend Lord Blencathra and his committee asked us very politely to look again at our drafting, and noble Lords suggested that the Bill needed to move from a skeleton Bill to a true framework Bill.

Amendments 4, 6, 8, 9 and 11 make a number of important changes to the regulation-making powers in Clause 1. They provide for the overarching objective sought by my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf. When exercising the power to make regulations, they are to be made in pursuit of the objective of safeguarding public health. That provides all the benefits that my noble friend set out in Committee—an objective test. I do not propose to dwell long on this, as my noble friend explained it so eloquently when he proposed his own amendment then.

However, the noble Baroness, Lady Thornton, has put forward Amendment 5, which would alter the wording of that overarching objective. This would amend the objective from safeguarding “public health” to safe- guarding

“the health and safety of the public”.

This was, as she knows, the original language of the government amendment in Grand Committee. I expect that the noble Baroness is querying rather than pressing us on this drafting. I say to her that, in the spirit of collegiate drafting, we have adopted the language proposed by my noble friend Lord Lansley. He made a good argument in Committee; we have listened. It was repeated during our conversations outside Committee, and we saw this amendment as a product of the whole House rather than simply the Government. I hope that that answers her questions here.

Turning back to the government amendments, they update the considerations that must be given regard to in pursuit of that objective. Noble Lords did not find the clarification of “attractiveness of the UK” clear enough. A number of alternatives were proposed, setting out the sorts of activities that noble Lords thought were good things to promote. My amendment does away with “attractiveness” and supplies a consolidated list of the sorts of activities that we hope the UK will be seen as a favourable place to undertake. This is absolutely in line with the Government’s intention to support the life sciences sector that we have now and to encourage innovation and interest in the UK as a good place to do business in future.

Among others, my noble friend Lady Cumberlege, the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Thornton, made salient points about the importance of safety. While there has never been any intention that making the UK attractive to the life sciences sector should make patients less safe, we have provided for a clear and unambiguous lock on patient safety—that is, as part of the decision-making process behind regulatory changes, if proposed changes have an impact on the safety of human medicines, the appropriate authority may make those changes only if the benefits outweigh the risks.

This is very clear. There may, as I said earlier during the Bill’s passage, be instances where we do need to make changes that deregulate to ensure the supply of medicines. We have made changes to address the rollout of a vaccination programme; that is absolutely the right thing to do. It requires an assessment of the risks by the experts and requires the benefit—a benefit that the noble Lords who spoke to me at length on this agreed was present—to outweigh the risks. Equally, there is regulatory change that may have no impact at all on safety.

In Amendments 12, 34 and 48, the noble Baroness, Lady Thornton, presses me on the criteria for making this assessment of risks and benefits and on whether the Government will publish that assessment. On the latter point, I can assure her that the amendments made in Committee entirely provide for this. We have already committed to publishing our initial assessment of proposals when we go out to public consultation. That will be the first exposure of our thinking on all aspects, not just risks and benefits. It will be open for persons who respond to that consultation to disagree with us. On the basis of that consultation, we will publish an Explanatory Memorandum when we lay the regulations. There will be ample opportunity to check our homework.

On the criteria, it will not be news to the noble Baroness when I talk of the challenge of specifying a single set of criteria that could apply for the assessment of the risks and benefits of all changes, when regulations may make vastly different changes to the existing regimes. I know that we spoke about these issues with other noble Lords during the discussions preceding Report. I simply do not think that this is necessary or helpful. When the Secretary of State makes amending or supplementary regulatory changes, the Minister will take advice, including from the host of experts inside the MHRA and the VMD, whose day-to-day responsibility it is to protect safety. We have all heard from the excellent Dr June Raine on the importance of safety. It makes sense to take a sensible approach to assessment, particularly in the light of the fact that we will set it out in the ways I have spoken to.

I am very pleased that we have arrived at a formulation that works. It is practicable and good legislation at the same time. Amendments 29 to 33 repeat this set of changes in relation to the regulation-making powers at Clause 9 for veterinary medicines—with an important distinction. The difference relates to how the overarching objective is formulated. This reflects the material differences and choices made for the regulation of veterinary medicines, such as reserving certain medicines for use in humans to avoid further antimicrobial resistance. It is right that we have an objective but that that objective works in this context. It is also right that the same lock on safety is applied.

Amendments 42 to 45 and 47 would apply the same framework to the regulation-making power in Clause 14 in relation to medical devices. When making amending and supplementary changes to the regulation of devices, it provides a separate but similar list of activities that we would wish to be seen as favourable, including the addition of carrying out research on medical devices. In the light of our debate in Committee and the debate we have ahead of us on the importance of medical technologies, this inclusion is absolutely right.

I do not propose to take significant time speaking to Amendments 73 and 94. They both make minor changes, but for an intent with which I do not think any noble Lord would disagree. In the interests of clarity, Amendment 73 would require a consultation on regulations under Clauses 1, 9 or 14 to include a summary of the assessment of the person making the regulations of all matters mentioned in these clauses. Amendment 94 serves to clarify the commencement of the definition of “human medicines provision” at Clause 5.

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[Lord Bethell (Con)]

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

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

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

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

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

[Baroness Thornton (Lab)]

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

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Moved by

[Lord Bethell]

6: Clause 1, page 1, line 11, leave out “they would” and insert “regulations under subsection (1) would contribute to this objective”
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name substituting Clause 1(2).

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[Baroness Thornton (Lab)]

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

[Lord Bethell (Con)]

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

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

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

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

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

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

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

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

[Lord Clement-Jones (LD) [V]]

I thank my noble friend Lady Jolly, the noble Lord, Lord Hunt, and the noble Baroness, Lady Thornton, for their helpful contributions and support today. I also thank the Minister for his reply; I regard it as something of a curate’s egg, but I recognise the thought that has gone into it, particularly his statement on the overarching principles in Clause 1 governing Clause 3 and the fact that the benefits must outweigh the risks in any scheme. He talked about the affirmative procedure; I very much hope that we will retain the super-affirmative procedure, which encourages me that there will be greater scrutiny of any new framework.

The Minister also spoke about the statutory duty to consult on proposals and the duty to secure data. He said that no patient data was being used and that, at the end of the day, the essence of this is to maximise the use of data where it is in the public interest. He gave research as an example that might be outside patient safety—I doubt it, but he thought it might be interpreted as going beyond patient safety. I was very struck by the noble Baroness, Lady Thornton, saying that there was an element in this of having a power that might come in useful; indeed, the Minister almost repeated that in saying, “We’ll see what data we have collected.”

I take some comfort from what the Minister has said. We have had some very productive debates and some important amendments secured, so I will not press this amendment today. However, the noble Lord probably has to suffer the potential of being immortalised on a Pepper v Hart basis if there is any subsequent dispute about the width of regulations made under this clause and whether Clause 1 limits the scope of Clause 3. I am sure he looks forward to that. In the meantime, I beg leave to withdraw my amendment.