(5 years, 1 month ago)
Lords ChamberMy Lords, I too shall be brief and I too am grateful to the Minister and his team for giving Peers an opportunity to see the Commons amendments to the Bill before they were tabled, so that we might give some feedback. One of the things that has made this Bill a pleasure to work on is the open way in which political parties and Cross-Benchers have worked together, as well as the way that the Minister and his team have worked with us. We particularly welcome the clauses that have come to us from the Commons; they make the Bill a more explicit and effective piece of legislation than when it was debated either in Committee or on Report in this House.
My Lords, I am very grateful to the Minister and his team for the manner in which they have engaged and worked with us throughout the passage of this Bill, particularly at this final stage. The amendment in lieu is a good compromise that reflects the need for scrutiny to be at the heart of the Bill. It provides a mechanism to examine the powers of the Act in five years’ time and will open the door for the restructuring and consolidation of the post-Brexit medicines and medical devices regulatory regime. We believe that this will prove both desirable and necessary, and look forward to working with the Minister on such issues when the time comes.
We welcome the requirement that the Secretary of State must specifically consider whether this should be in the form of primary or secondary legislation and hope that this will lead to policy being put into a future Bill rather than scrolled away in regulations. The Secretary of State will also have to take account of all parliamentary committee reports. This would include post-legislative scrutiny undertaken by a Select Committee, as well as the DPRRC and Constitution Committee, whose oversight played a crucial role in reshaping a skeleton Bill into a framework Bill; I thank the noble Lord, Lord Lansley, for explaining that to us all. I hope the Minister can assure me that stakeholders will also be consulted. I am sure that that will be the case. It is very important, given that they are the end users of the legislation, and for the report to have value and credibility it must reflect the experience of regulators, industry, patients and medical professionals.
Finally, the tidying-up amendment that retains the requirement to share information in the public interest is an important provision because it will allow for substantive and ethical issues relating to the sharing of public data to be considered. This is of the utmost importance, given the role that the NHS and patient data may have in future trade deals.
My Lords, I do not intend to repeat much of what I said at Third Reading. Many thanks to the noble Lords who have contributed to the changing shape of the Bill. From Committee to ping-pong, we have listened, heard proposals for change and brought workable, practicable compromises forward.
I wish to repeat the remarks made by the noble Baroness, Lady Thornton. She congratulated all of us on the effective communication that has made it possible to make considered progress on this Bill, despite all the challenges that Covid-19 has presented us with. This a very fair assessment; I agree with it completely. From the report of my noble friend Lady Cumberlege to the demonstrated expertise of our medicines regulator, the MHRA, we have seen the importance of patient safety, clinical trials, our life sciences sector and effective regulation bear out in our hospitals, clinical trials and patient community.
I look forward to the debates ahead of us on the regulations that will be made under the Bill. They will be important, as we set forward on our course for the best possible regulatory regime for the UK, with the patient at its heart.
(5 years, 1 month ago)
Lords ChamberTo ask Her Majesty’s Government what plans they have to ensure that the second dose of the Pfizer/BioNTech COVID-19 vaccine is delivered to patients within 12 weeks of receiving the first dose.
My Lords, the second dose completes the course and is vital for long-term protection. That is why all patients will be offered a second dose between 77 and 84 days after receiving their first. We have already vaccinated almost 9 million people, with the ambition to reach the 15 million people in the most vulnerable groups 1 to 4 by the middle of February.
I thank the noble Lord for his partial reassurance; however, the question is actually whether there will be a supply available in the timeframe. Given that any unvaccinated area provides a potential pool for new strains of Covid to develop and re-infect the world, extending immunisation to the whole world is not
“only a matter of altruistic engagement,”
but “of enlightened self-interest,” to quote Tony Blair. Does the noble Lord agree that countries must come together to reject vaccine nationalism in favour of co-operation? At what point in terms of vaccination of priority groups will the UK be able to make vaccinations available to other countries that are in need?
I completely agree with both the noble Baroness and the former Prime Minister Tony Blair on this matter. Not only must we vaccinate our own country, but we are not safe until the whole world is vaccinated. That is a basic public health and epidemiological observation. It is why we are very committed to international efforts—to CEPI, Gavi, COVAX and ACT. They are all working hard to get fair distribution of vaccines. We have also put £571 million into the funds at COVAX to support vaccines for the developing world. However, we have to start at home and it is not possible to make a commitment on the schedule for when we will be in a position to think about exporting vaccines until that is completed. When it is completed, I will update the House accordingly.
(5 years, 1 month ago)
Lords ChamberMy Lords, there was a very worrying story in the media this weekend, which I hope the Minister will use this opportunity to clarify. We learned that the MHRA and NHS Digital have issued official instructions on how to use NIVS, saying that where staff do not have an NHS number, the vaccine should not be given. One email sent to a hospital explicitly states that overseas nurses without NHS numbers, even on the front line, should not be vaccinated. And what about security staff, porters, student nurses coming from outside the country to work for us and staff such as cleaners? Through contracts, lots of people from BAME backgrounds and recent immigrants working in the NHS are not registered with GPs, do not use the NHS, and do not have an NHS number. How can it possibly make sense, from a public health point of view, not to vaccinate everyone on the front line?
(5 years, 1 month ago)
Lords ChamberMy 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.
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.
(5 years, 1 month ago)
Lords ChamberMy 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.
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.
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.
(5 years, 1 month ago)
Lords ChamberMy 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.
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?
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.
(5 years, 1 month ago)
Lords ChamberMy Lords, the whole House will welcome this White Paper. The overhaul of the Mental Health Act has been long awaited. It is also to be welcomed that the Government have accepted the majority of the recommendations from Sir Simon Wessely’s independent review of the Mental Health Act. As Sir Simon Wessely’s report highlighted, there is a great need for patients to be heard, for their choices to be respected and for them to be supported to get better in the least restrictive way.
Although legislative changes are important, the best way to prevent people being detained under the Mental Health Act is to prevent them reaching a crisis point in the first place. This means bringing reality to equality for mental health, bringing in investment and training, and introducing a culture change in the NHS.
My first question is whether the investment detailed in the long-term plan will be sufficient to achieve that. Many of the organisations which have championed mental health doubt that it will. Surely we will require greater investment to implement the proposals of the White Paper.
The Government accept almost all the review’s recommendations on advocacy and tribunals, including the funding that will be required to implement them. These are key reforms affecting people’s liberty and will play an important part in making other improvements to people’s rights effective. Can the Minister assure us that planned reforms will be fully funded?
The independent review was published over two years ago. Since then, the murder of George Floyd and the growth of the Black Lives Matter movement have brought the impact of structural racism into greater focus. Among the five broad ethnic groups, the known rate of detention for the black or black British group—321.7 detentions per 100,000 of the population—was over four times that of the white group, which was 73.4 per 100,000. Men and women from African-Caribbean communities in the UK have higher rates of post-traumatic stress disorder and suicide risk and are more likely to be diagnosed as schizophrenic. Does the White Paper go far enough in tackling the racial disparities within our use of the Mental Health Act? It is very much to be welcomed that the Secretary of State has announced the new patient and carer race equality framework, which was recommended by Sir Simon Wessely. Can the Minister tell us the timetable?
On health inequalities in general, children from the poorest 20% of households are four times as likely to have serious mental health difficulties by the age of 11 as those from the wealthiest 20%. Half of LGBT people—52%—have experienced depression in the last year. One in eight LGBT people aged between 18 and 24 say that they have attempted to take their own life in the last year. Almost half of trans people have thought of taking their own life in the last year, and 31% per cent of LGB people who are not trans say the same. People living in the most deprived areas are more likely to be referred to an IAPT service by their GP but are substantially less likely to receive a complete course of treatment or make a successful recovery. Long-term funding decisions will be needed in the next spending review. What will they look like? Will the Government make a long-term commitment to invest when this is required?
I am sure we all welcome the aim to improve how people with learning difficulties and autism are treated under the Act. Will there be limitations to the scope for detention where their needs are due to learning disabilities or autism alone? Do the Government accept all the review’s recommendations on advocacy and tribunals, including the funding that will be required to implement them? These are key reforms affecting people’s liberty and will play an important part in making other improvements come about.
The emergency legislation of the Coronavirus Act 2020 represented a concerning reduction in patient rights and safeguards. While we understood the reasons for their initial introduction, I am sure that everyone is glad that they were never enacted and pleased that they have now been dropped. However, Covid-19 will prove a defining moment for the way in which we discuss and protect our mental health. A rising tide of people who have not previously experienced mental health problems now find themselves in that position. For a lot of people, the pandemic has seen a shift from merely “struggling” to becoming clinically unwell. Funding and reform will be needed more than ever.
Finally, can the Minister tell us when the legislative programme will commence? Is there to be a joint pre-legislative scrutiny committee? I believe the Minister’s right honourable friend the Secretary of State suggested that that might be the case. That would be very welcome and I hope that it will start very soon indeed. When, finally, will we see the draft Bill?
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.
(5 years, 1 month ago)
Lords ChamberMy Lords, this amendment requires the Secretary of State to publish a strategy for tackling anti-vax disinformation within one month of the Bill passing, to safeguard public health. The strategy should include proposals to build public trust and encourage uptake of vaccines, require social media platforms and companies to promptly remove anti-vax disinformation, and prevent profiting from vaccine disinformation through advertising revenue. The context to this amendment is the problem that lies designed to erode trust in vaccines and persuade people not to protect themselves and their families are being broadcast to millions of people online every day.
Covid-19 has been a “growth opportunity” for anti-vaxxers, according to research by the Centre for Countering Digital Hate, which estimates that the largest English-language social media accounts promoting vaccine scepticism have increased their followers by nearly a fifth over the past year. Intelligence assessments suggest that while the majority of anti-vax propaganda seen by UK internet users comes from within Britain, a small proportion of it is being amplified or initiated by hostile states, notably Russia.
Whereas the normal vaccine debate is largely limited to the parents of young children and teenagers, the Covid-19 pandemic is a rare instance where the entirety of a society has to choose whether they wish to be vaccinated. The spread of disinformation online presents a “real and present danger” to vaccination efforts. This is why action must urgently be taken to tackle anti-vax campaigns and build public confidence to save lives.
Disinformation is distinct from legitimate scientific questions and scrutiny, although valid concerns can be and often are manipulated. Disinformation encompasses the full spectrum of—
My Lords, I think I am back now. I apologise: I have no idea what happened then, but the trusty old iPad is coming in useful. I think that when I lost my link I was talking about media companies, so I will pick up with that.
Despite the Government’s and social media companies’ announcement last week of new measures to tackle the issue, dedicated anti-vaccine groups with hundreds of thousands of members on social media are still churning out disinformation—100,000 Facebook users and 180,000 on TikTok. Although the Government have talked about online harms for a long time, it is unlikely that that legislation will have Royal Assent in time to help with this.
Finally, the situation was made clear in the Question in the House yesterday from my noble friend Lady Lawrence about the BAME community and the vaccine being rolled out. She said:
“I have heard messages from the black community about their mistrust of and lack of confidence in the vaccine. I ask Her Majesty’s Government: what proportion of those taking part in the vaccine trials were black, Asian or from ethnic minorities before the rollout?”—[Official Report, 13/1/21; col. 725.]
That was amplified by the noble Baroness, Lady Warsi, who made the point that, although BAME communities were initially less likely to accept a Covid vaccine than white communities, when they had the opportunity to discuss their concerns with healthcare professionals, they were more likely than white communities to be persuaded to have the vaccine. Is the noble Lord familiar with that polling, and will he follow it up? I beg to move.
My Lords, first, I apologise to the House because this is the first time I have spoken on this Bill, so I will not detain the House long. However, I support the aims of the amendment. This is something I have felt strongly about for some years.
Tackling anti-vax disinformation can be life-saving, and continuing to promote anti-vax messaging can be so damaging to public health as well as individual health. As the noble Baroness, Lady Thornton, rightly said in her excellent introduction—I am grateful to her for tabling the amendment—the online anti-vax messaging problem is growing. It is not just from a tiny minority in any one country; there could be systemic efforts to damage public health in our country and others. Given that those minority views can be spread, potentially to the severe detriment of the public and those who perhaps tend to support those views, believe them or be convinced by them, I should be very grateful if my noble friend would explain to the House the Government’s position. What do they believe they can do to combat the anti-vax messaging, not least as we are in the middle of this dreadful pandemic, for which the way out seems to me and many others to be to vaccinate as much of the population as we can, as soon as we can, to enhance their protection? Therefore, this is a very important and live issue, given the dreadful consequences that the pandemic is having not only on health through the virus itself, but on other aspects of public health and the country’s wider ability to support our beloved NHS.
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.
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.
These amendments relate to the use of data and information sharing. The noble Baroness, Lady Thornton, my noble friend Lord Clement- Jones and the noble Lord, Lord Patel, have put their names to some of them. The noble Lord, Lord Freyberg, outlined clearly in the context of trade and health the power and value of data. Data is a hugely rich source for research but also a hugely valuable commodity, so we need safeguards.
Concern was raised in Committee about the level of protection in the Bill for patient information, as regulations are able to make provision about the disclosure of such information. I am grateful to the Minister for being so willing to look at this again.
The Government have responded in two main ways: with the introduction of a definition of “relevant person”, thereby narrowing the definition of whom data can be shared with, and by defining what is meant by patient information. As the noble Lord, Lord Patel, explained, Amendment 24 in the name of the noble Baroness, Lady Thornton, strengthens the definition of patient information to protect information that could identify a patient, rather than just information that does.
Amendments 18, 36 and 57, led by the noble Baroness, Lady Thornton, and supported by my noble friend Lord Clement-Jones and others, would allow a relevant authority to disclose information to a person outside the UK only where required for the purpose of giving effect to an international agreement or an arrangement concerning the regulation of human medicine, provided it was within the public interest so to do. Those three amendments all pass the test put forward by the noble Baroness, Lady McIntosh of Pickering, concerning public good.
Amendment 20, from my noble friend Lord Clement-Jones, would take the Government’s amendment on patient consent further by ensuring that consent given in relation to identifiable information was informed consent. The noble Baroness, Lady Cumberlege, has just raised the issue. We should not need this. Informed consent should be the default but, as it clearly is not, I support my noble friend’s Amendment 20.
Similarly, Amendment 21, in the name of the noble Baroness, Lady Thornton, would ensure that patient information could be shared by an appropriate authority only if the individual to whom it related had given their explicit consent.
These amendments strengthen the Bill and therefore patient outcomes. I will listen to the Minister to see what plans the Government have to satisfy noble Lords on this group.
My Lords, I thank all noble Lords who have taken part in this debate. I will speak to the amendments in my name, and give notice that I will test the opinion of the House on Amendment 18, along with Amendments 36 and 57, all of which are supported by the noble Lords, Lord Patel, Lord Freyberg and Lord Clement-Jones. This is unless—of course, I always live in hope—they are agreed to by the Minister.
Turning to the other amendments in my name in this group, I just want to put on record how grateful we are on our Benches for the way that the Minister and the Bill team have worked on these important issues, and how much we support the amendments that he has tabled. We do not see these amendments as in opposition; we see them as amplification and clarification.
Amendment 24 is a probing test for whether aggregate data could identify individuals through de-identification or de-anonymisation practices. The Government’s amendments define patient information as data that
“identifies the individual or enables the individual to be identified (whether by itself or in combination with other information)”.
This represents a welcome tightening up of the definition to include scenarios where contextual information might allow de-identified data to become identifiable. This is very important given that aggregate data can reveal patterns which allow for reidentification, especially for small patient clusters as in rare diseases and conditions. Given the rapid development of sophisticated technology, my Amendment 24 probes the test for whether anonymised aggregate data could identify individuals through this. I hope the Minister will be able to assure the House that the appropriate safeguards and checks are in place.
Amendment 21 would ensure that patient information
“can only be shared by an appropriate authority if the individual to whom it relates has given their explicit (‘opt-in’) consent.”
We welcome the Government’s requirement for consent to share patient information. However, they have not specified how this consent mechanism will work in practice. This amendment in my name would ensure that important distinction, which has been mentioned by many noble Lords across the House. Other noble Lords have also mentioned care.data, which, because of a lack of clarity about the use of data, did not work. I hope the Government will be able to assure us that explicitly informed consent will be sought and secured.
Under Amendment 18, followed by Amendments 36 and 57, data would be disclosed to persons under international agreements or arrangements only for pharmacovigilance or if “in the public interest”. I hope the public interest bit answers the question from the noble Lord, Lord Lansley. I thank the noble Lords, Lord Patel, Lord Clement-Jones and Lord Freyberg, my noble friend Lord Hunt and other noble Lords for their support for this suite of amendments.
Overall, the government amendments narrow discretion and set out in more detail the purposes for the information-sharing powers. However, in our view they still potentially allow for the disclosure of patient data without consent to commercial partners for undefined, and therefore unknown, purposes to be settled as part of international agreements or trade deals. That is why the helpful read-across to the Trade Bill by the noble Lords, Lord Freyberg, Lord Clement-Jones and Lord Patel, is so important. We recognise that information-sharing and disclosure may be necessary to allow smooth functioning and support internationally on pharmacovigilance, for example, but remain concerned that NHS data—which has been described as a treasure trove, worth perhaps £9.6 billion—could be bartered as part of commercial interests in trade deals.
Amendment 18, along with Amendments 36 and 57 in my name, would allow the Secretary of State to disclose NHS data only under the terms of an international agreement or trade deal for pharmacovigilance, of if it is otherwise in the public interest. We believe “the public interest” is a legitimate test that would offer reassurance that substantive and ethical issues relating to the sharing of data would at least be considered. I hope the Minister will recognise the value of this amendment; otherwise, as I say, I would like to test the opinion of the House.
I beg to move, and I wish to test the opinion of the House.
Does the noble Baroness, Lady Thornton, wish to move Amendment 27?
I thought these amendments were part of the group that was passed on Tuesday?
The noble Baroness is correct that Amendment 27 is consequential to an amendment agreed on day 1 of Report, so she may wish to move it.
I think Amendment 26 is similar, possibly. We may need some guidance from the clerk. Was Amendment 26 also related to the group of amendments that were agreed on Tuesday? I apologise; it is always difficult to do these things when you are not actually in the Chamber.
My understanding is that Amendment 26 is also consequential to amendments passed on day 1 of Report, so we may wish to ask the noble Lord, Lord Patel, whether he wishes to move his amendment, which is consequential to previous amendments agreed.
I will go back to Amendment 26. Does the noble Lord, Lord Patel, wish to move Amendment 26?
Does the noble Baroness, Lady Thornton, wish to move that amendment?
The noble Baroness, Lady Jolly, is quite right: two of our health big thinkers have laid out the issues here. My noble friend Lord Hunt gave a wonderful introduction to Amendment 66, which covered the reasons why it is important and what it will do. The noble Lord, Lord Lansley, took us on a journey through how health inequalities can be addressed. The point, and the reason the amendment is on the Marshalled List today, is that it does not always work like that. Implementation is key. As the noble Baroness, Lady Jolly, said, requiring NICE to support NHS access to new medicines and medical devices seems kind of obvious. The challenge for the Minister here is how to use this legislation and this discussion to make what we think is obvious work better.
My Lords, I know the noble Lord, Lord Hunt of Kings Heath has a long-term interest in and commitment to the work of NICE and, as such, will know that NICE’s remit is set out in other legislation. I do not intend to rehearse the arguments on why we do not see that as strictly for this Bill. Instead, I hope to provide some reassurance on the issues he raises with his amendment.
The noble Lord will be aware that NICE’s methods and processes for assessing the cost-effectiveness of medical technologies are internationally respected and have been developed over almost 20 years through periodic review, including extensive engagement with stakeholders, and the latest iteration of that process of periodic review of its methods is ongoing. NICE finished the first phase of its consultation on the case for change to its methods on 18 December 2020. There will be a second consultation on the case for change to its processes in the spring. The result of those will inform the final consultation on the updated methods manual in summer 2021. I hope that the noble Lord is reassured by the consultative nature of that process in considering the issues he raised.
Subsection (1)(a) of the new clause proposed in his amendment would require NICE to address the implications of health inequalities when assessing the cost effectiveness of medicines and medical devices. Subsection (1)(b) would require NICE to accept a greater degree of uncertainty and risk in recommending their use. I reassure the noble Lord that NICE is already considering both of those as part of its review, and they were both consulted on as part of the consultation on the case for change that ran from 6 November to 18 December 2020.
In that consultation, NICE noted that there may be a case for a modifier that considers health inequalities. However, further work is needed to explore how this could be defined and implemented in a health technology evaluation, and under which circumstances. This will be done in NICE’s second consultation running from February to March. Such a modifier could consider the types and sources of inequality, as well as how a modifier should be applied—qualitative or quantitative. It could also consider whether such a modifier covers technologies that directly reduce inequalities—for example, by specifically targeting or providing additional benefits for a disadvantaged group; or whether indirect effects might also be considered—for example, if a technology has uniform benefits across groups, but the condition disproportionally affects a disadvantaged group. At this stage, it is not clear that there is sufficient evidence for a health inequalities modifier, but it is being explored, and will be explored further in the second stage.
I hope that level of detail on the consideration that NICE is undertaking helps to reassure the noble Lord, but of course it would not be appropriate to pre-empt that review, and we want to encourage all stakeholders to respond to it.
In addition, I remind the noble Lord that a requirement to have regard to reducing health inequalities is already imposed on NICE under Section 1C of the National Health Service Act 2006. This applies to NICE as a non-departmental public body of the Department of Health and Social Care.
Proposed new subsection 1(c) would require NICE to have regard to the need
“to ensure patients with rare diseases have access to medicines and medical devices”.
The noble Baroness, Lady Wheeler, noted some concern during Grand Committee as to why NICE did not propose a rarity modifier in its methods review. A rarity modifier was considered by NICE prior to publication of the consultation document. However, stakeholders noted that rare diseases would be covered by the proposed severity modifier, which more accurately reflects society’s values. Although there is of course overlap between severity and rarity, not all rare conditions are severe and some severe conditions are more common. Of course, the consultation was an opportunity for all stakeholders to express their views on this point. As noted previously, NICE is also consulting on changes, such as a more accepting attitude towards uncertainty in some situations, which should benefit medicines for rare diseases.
Where there is uncertain evidence relating to a medical technology—I appreciate this can be a challenge for rare diseases—NICE and NHSE&I have developed managed access agreements. NICE has already recommended six topics for use subject to a managed access agreement outside of cancer. NHSE&I continues to use its sophisticated commercial capabilities to negotiate deals with industry that enable patients to access the most innovative new medicines and ensure that the NHS gets good value.
Proposed new subsection 1(d) would require NICE to have regard to supporting
“the use of curative therapies involving medicines and medical devices.”
The word “curative” should be used with caution, as there is no standard definition of what might be meant by it. For example, in some cases it may mean a significant amelioration in symptoms, in others that the treatment pathway is different or more tolerable.
While I appreciate that recently launched advanced therapy medicinal products hold great promise by targeting the specific cell or genetic defect, the data on long-term effectiveness is often immature at the time of marketing approval. Further, we need flexibility to respond quickly and effectively to developments in life sciences. We want to avert a situation whereby an effective therapy is not guaranteed funding because it did not meet the legal definition of a “curative therapy”. However, I think that the noble Lord was more trying to get at our support for some of these innovative approaches. Again, this is being looked at in the review of NICE’s methods.
NICE’s working group has explored whether there is a case for changing the approach to discounting, which the noble Lord asked about, in particular the impact on technologies with long-term benefits such as one-time gene therapies. This is a complex area that needs to take into account the policy-level need to support particular types of technologies or circumstances, the limitations of the current criteria for non-reference case discounting, and the effects and any accompanying policy and affordability challenges of any change. This will be covered by the second stage of the NICE methods review. Again, while we would not want to pre-empt that review, all stakeholders are encouraged to respond to it.
Briefly, proposed new subsection (2) would require the Secretary of State to lay a report and impact assessment before both Houses of Parliament, setting out how NICE has implemented its duty under proposed new subsection (1). As I said in Grand Committee, NICE will publish its revised methods and process manual, including its impact assessment, on its website for all to access, including parliamentarians, once the process has been completed. That is the correct forum.
I will briefly address Amendment 46 in the name of the noble Baroness, Lady Finlay, which touches on similar issues—the importance of access to medical technologies, the future medical devices regulatory regime, and the critical nature of medical device safety. I pay tribute to the noble Baroness’s work through her engagement with Ministers and our officials in developing government Amendment 45, which provides greater clarity on the types of activity we would intend to encourage through appropriate regulation. That includes, in respect of medical devices, carrying out research, developing medical devices, or manufacturing and supplying medical devices.
The Government support the agenda for early access to medical devices for NHS patients, as demonstrated through other mechanisms such as the rapid uptake products programme, managed by Accelerated Access Collaborative, and the medtech funding mandate, due to launch in April.
The second stated purpose of the noble Baroness’s amendment—to allow monitoring of the safety and efficacy of medical devices in real-time use—is already achieved by regulations that may be made under Clause 15(1)(i) and (j), so the mechanism to deliver this is already in place. In addition, Clause 18 empowers the Secretary of State to make regulations for the establishment of a medical device information system by NHS Digital, which will support the monitoring of patient outcomes and patient safety.
The noble Baroness also asked about the timeframe for future devices regulation made under the Bill. I assure her we will consult on this issue this year.
I hope the reassurances I have provided, here and during Committee, are of comfort to noble Lords and that the noble Lord, Lord Hunt of Kings Heath, feels able to withdraw his amendment.
(5 years, 1 month ago)
Lords ChamberThe 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.
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.
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.
(5 years, 1 month ago)
Lords ChamberMy Lords, I thank the Minister for allowing this Statement to be taken. This is a challenging moment in the handling of the pandemic. We have growing infection rates; we are in lockdown; businesses are shut; schools are closed. Tragically, more than 80,000 people have already lost their lives to this awful virus. However, the vaccine provides us with a light. It is a glimmer of hope; a way to beat the virus, save lives and get us back to normal. I congratulate the Government on investing in multiple vaccine candidates —that has definitely paid off. But a vaccine alone does not make a vaccination programme. Given the Government’s record with test and trace, and the procurement of PPE, it is right that the Minister will face many questions about the delivery and implementation of the vaccine programme.
The plan that has been launched is quite conventional. Aside from big vaccination centres, it uses traditional delivery mechanisms, operating within traditional opening and access times. If the Secretary of State’s target for the number to be vaccinated is to be reached, exceptional circumstances call for an exceptional response. Why did the Government believe that 24/7 access is something that people would not be interested in? What is that view based on? However, I see that, in a characteristic U-turn, Prime Minister Boris Johnson has said today that the coronavirus vaccine programme will operate 24 hours a day, seven days a week, “as soon as we can”. What does this actually mean? When will the details of the plan to provide this service be published? The Secretary of State has said that the only limiting factor on the immunisation programme will be the speed of supply. Can the Minister confirm that this plan will receive the supply which is needed?
I think we can all see that the logistics of vaccinating a nation are huge, and we now hear many anecdotal stories about the reliability of supply, the organisation of vaccination, cancelled appointments and uncertainty of supply. On 17 December, I asked about the inoculation of our NHS staff, as it seemed obvious to me that, if we did not give vaccines to those dealing with the most sick Covid patients, and given the spike we are now experiencing, we would find many of our precious NHS staff becoming ill—as indeed we have. We are now experiencing the consequences. We are currently missing around 46,000 NHS staff for Covid reasons. When will all our NHS staff have been vaccinated?
What consideration has been given to vaccinating patients who are going to be in hospital? I am thinking, for example, about maternity services. Has it been considered that expectant mothers, and those who have just given birth, should also be vaccinated?
London currently has by far the highest rates of Covid in the UK, yet it is receiving fewer doses of the Pfizer and Oxford vaccines per head of population. Will the Minister commit to providing those desperately needed additional supplies urgently?
We are all reassured to see pharmacies included in the plan. They are at the heart of the communities of our country. They are trusted and are all ready to deliver mass vaccination. It is slightly odd that the number being trailed publicly is of 200 participating pharmacies, given that there are in fact 11,500 community pharmacies in England. Can the Minister clarify whether that is right? Why are not more involved, or is that number wrong? Can the Minister share with us what the number is?
On social care, it seems that about 23% of elderly care home residents have been vaccinated compared with 40%—which is brilliant—of the over-80s. Given their top prioritisation, can the Minister tell us when all care home residents will have been vaccinated? Will it be the end of the month, as has been promised?
When is it likely that our school and nursery staff will be vaccinated? I can see that the prioritisation lists are difficult and demanding—there is huge demand on this vaccine—but if we are to return to any semblance of normality, we need to get our children back to school.
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.