Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

My Lords, teachers are a priority in as much as they are on the prioritisation list along with other key workers, but the honest assessment of the JCVI is that teachers are not at accelerated risk of increased sickness or hospitalisation over any other member of the public. We are enormously grateful to the teaching profession for the role it is playing in getting schools back and in testing but, in terms of sickness and mortality, teachers are in the right place in the JCVI prioritisation.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

I do not have the precise figure to hand. Those in group 4 will include those with Down’s syndrome and other CEVs; those with severe or profound learning disabilities will be in group 6. As we know, group 4 has had an extremely high conversion rate and, although I do not think it is exactly 100%, it will be an astonishingly high amount and, if those figures are available, I should be glad to write to the noble Baroness with them.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

My Lords, I do not necessarily accept the dichotomy the noble Baroness refers to. I think it is reasonable for dentists to triage patients between those who can be treated with either advice, analgesics or antibiotics, and therefore do not need face-to-face contact, and those who need to be prioritised to, for example, the urgent dental care centres. I commend the dental profession for making good choices in that area. With regard to the treatment of children using anaesthetics, those are not statistics I have to hand, but I would be glad to write to the noble Baroness with whatever information we have.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

My Lords, as I said earlier, 88% of NHS dentists are open. I was at an NHS dentist earlier today, and I pay tribute to all those dentists that are open. I do not know the specific situation in north and east Cornwall, but those in acute pain have access to the 695 urgent dental care centres, which are around England. I have enormous sympathy for those who have painful teeth, and I urge them to hunt down an appointment at one of those centres, where the service is excellent.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

My Lords, in terms of the numbers or proportion of those isolating, a large number of figures is being bandied around. Some apply to last year and some to this year. I raise doubts as to whether anyone truly knows what the behaviours of people are, but I reiterate that UCL reports that 80% are self-isolating for the recommended 10 days or more, and that figure has some authority. In terms of the support that we are offering to people, we have taken on board the recommendations of noble Lords on the Opposition Benches and local authorities are using targeted support that suits the communities in which they work to provide that kind of support. We have provided substantial financial funding and resources for local authorities to provide the support needed.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

We are hesitant to send teams of healthcare workers to people isolating because of the fear of infection. Obviously, having people attend those who have either tested positive or are the contacts of those who have tested positive does not comply with the latest hygiene protocol, but the noble Baroness is entirely right, and one way in which we could work harder is to use volunteers and community groups to provide pastoral and practical support for those isolating.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

My Lords, I entirely agree with the noble Lord. He is right that additional vigilance is required. The advent of new variants that could have higher transmissibility or escape the vaccine is a complete game-changer, and that is why we have changed our approach to border management. We have upgraded our border control measures, and there will be further government announcements on that. We have introduced red lists of countries where there are variants of concern, and we have implemented Project Eagle, the tracing project to track down those who have tested positive in genomic sequencing for variants of concern.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

The noble Baroness is completely right to cite Australia, and we take our hat off to its remarkable achievement in using its island status to protect itself against the virus. We are responding to the challenge of new variants by upgrading our measures, and announcements on this will be made shortly. The CMO’s view on the variants of concern so far is that we should have a proportionate system, which means an upgrading and not necessarily an Australia-style system. But we are putting in place the kinds of measures that could be upgraded to an Australia-style system were there to be a threat of significant magnitude.

Lord Patel (CB) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I am extremely grateful for the amendments that the Government have brought from the Commons. I am grateful to the Minister and his team for working so diligently with the rest of us, and to all noble Lords who supported my amendments. It is not unusual—but it is infrequent—for the votes that the Government did not get through in the Lords to be reconsidered in the Commons and brought back as government amendments. I am very content that the amendments that the Government have brought are very satisfactory and I congratulate them. I thank the noble Lord, Lord Bethell, the noble Baroness, Lady Penn, the noble Earl, Lord Howe, and the legal team for working with us throughout the Bill. That is all I am going to say.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

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.

Baroness Thornton (Lab) [V]

- Hansard -

Copy Link

- - Excerpts

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.

Baroness Cumberlege (Con) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I could not let this opportunity pass without expressing my gratitude to all those who have played such a vital part in drafting, scrutinising and improving this important Bill. I know that it will now return to the other place. I wish it a fair wind and hope that we will soon see it enacted.

Throughout, noble Lords from all sides of the House have, quite rightly, focused on using the Bill to strengthen patient safety. Safety is now threaded throughout the Bill. I do so welcome that; it is something that the noble Baronesses, Lady Thornton and Lady Jolly, have both just mentioned. We have enshrined a very important safety recommendation in the Bill: we will now have a proper database to record the medical devices that are used and on which we and patients will be able to track their outcomes and detect safety more quickly. I cannot overstate just how important that is. Without this data, the healthcare system has been flying blind.

I have been very touched by the kind and thoughtful expressions of support from so many noble Lords in general debates and, in particular, for my amendments, which were triggered by the recommendations in First Do No Harm. The report enshrined in me that, at every opportunity, we must be reminded that the NHS is run for the people and is paid for by the people. Right now, the NHS is demonstrating a total commitment to saving lives and defeating this deadly virus—a virus that, as it sweeps around the world, devastates lives, livelihoods, education, personal budgets and a national aspiration for a better world.

In the dark days of the Second World War, Beveridge was preparing for a better Britain. In these dark days, there is a need to make plans—not just to return to what was there before but to look forward to something better. I believe that the patient safety commissioner will provide something better and will improve patient safety and healthcare as a whole. I was thrilled that so many of your Lordships lent me their support in calling for this; I know that their voices made all the difference. I thank the Minister and the noble Baronesses, Lady Thornton and Lady Jolly, for their generous remarks today.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

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.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

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 Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

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.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

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.

Lord Naseby (Con) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I declare an interest in that I am married to a retired general practitioner.

I congratulate the noble Baroness on her proposed new clause. Whether the detail is correct is another matter, but the principle that she is promoting is absolutely right. I make my observations as someone who, before he came into politics, was a senior director in the fifth-largest advertising agency in the world. I was actually handling the UK Government’s COI account—that is, the general one for specific purposes.

I have four observations. First, all misinformation must be refuted immediately, wherever it occurs—whether it is in the main media or other media. That is not just social media; it includes radio, TV, print, posters, et cetera. Secondly, every medical professional body must make it unequivocally clear that disinformation must be refuted. Thirdly, I suggest that all medical outlets should provide a clear statement, in poster format, for hospitals, surgeries, clinics and pharmacies. Fourthly, consideration should be given to how best to communicate with schools, universities and colleges.

In conclusion, we must all remember the terrible harm that was done to the MMR—measles, mumps and rubella—programme, largely by one pioneering rogue doctor. Against that background, I plead with the Minister to ensure that we have a robust new clause and a plan, worked on now so that it can be communicated instantly, if possible.

Lord Naseby (Con) [V]

- Hansard -

Copy Link

- - Excerpts

It is a pleasure to follow my noble friend Lady Cumberlege, who has gone into great detail on these amendments. As far as I can see, these are mainly government amendments, plus some from other parties, and they are all broadly to be welcomed. The question I ask myself is: where are the boundaries to be set?

Very helpfully, the Minister, in his opening statement, explained in some detail the extent of information-sharing outside the UK and gave the example of the safety of medical devices. Having listened to my noble friend and the others who have contributed, I am still not quite sure about Amendments 18 and 20. I can see where they are coming from and can understand what is behind them but on this occasion I will have to listen to the Minister. These are sensitive areas and certainly we in the upper House should listen. I am also not entirely clear from the Minister’s statement at the beginning what the implications of Amendment 22 are. There has already been a good deal of coverage and I will not add to it further.

Baroness Thornton (Lab) [V]

- Hansard -

Copy Link

- - Excerpts

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.

Baroness McIntosh of Pickering (Con) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I am delighted to follow the noble Baroness, Lady Masham, and earlier speakers in welcoming this group of amendments. I support government Amendments 50, 64 and 96 and welcome the placing of the advisory committee on a statutory footing, and particularly that the affirmative procedure will be used.

My question goes to the nub of Amendment 50—in which regard, if this is correct, Amendments 51 and others in this group will not be needed. Is it for the Secretary of State to decide what goes in the regulations on which presumably Parliament will be consulted under the affirmative procedure?

I can quite understand that the use of “may” appears to be discretionary, leaving open what should be included. Having got this far, it would be helpful to understand the thinking behind the use of “may” in Amendment 50, which indicates that this may be discretionary, whereas clearly it appears to be the will of the House that this is mandatory.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

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.

Lord Lansley (Con) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I am most grateful to the noble Lord, Lord Hunt of King’s Heath, for his amendment and for the way he introduced it. It very helpfully allows us, at this very important moment, to take stock of how we secure the availability of medicines—although the legislation does not relate to NICE, and I am sure it will not surprise the noble Lord, Lord Hunt, that I do not think it is appropriate for us to legislate to tell NICE how to do its work, given its independent statutory constitution. None the less, the Bill is about the availability of medicines, and it is really important for us to identify how the NICE processes can assist in ensuring that we get medicines to those who need them.

I shall say a few words about the NICE processes. First, let me address the objective, from my point of view. When I was Secretary of State, I advocated a process called “value-based pricing”, which was to try to understand that not only were there quantitative factors measured in quality-adjusted life years—QALYs —which, if one were able to secure them, gave one a quantitative basis for understanding the value of a new medicine, but that in addition there were other qualitative aspects, which I described as the societal benefits and the innovation benefits. I still think that this is the right approach.

In the international context, many countries are trying to escape the potential downward spiral of reference pricing, where everybody is trying to pay less than the average. The net result, if we carry on down that path and if the American Administration pursue that path, will be that we end up with inadequate support for the industry for the development of new and innovative medicines.

What we need to do is to value innovation and support the industry for the value it delivers. However, we do not measure it precisely in those terms. When we look at our current structure in this country, we need to understand that there is an opportunity created by what is known as VPAS—the voluntary pricing and access scheme. If it is genuinely the case, and we have argued that it should be, that the industry has accepted a constraint on the overall growth of the medicines budget in the NHS, and if it is clear that, if that growth is exceeded, there will be a rebate and that rebate does indeed return to benefit patients, through the NHS or the innovative medicines fund, so promoting access to new medicines, then we will arrive at the point where both NICE and NHS England should be working together to try to secure the best value from that drugs budget. I think they should be working together to ensure that, where there is a mandate for a new medicine, it is one which is supported by, not imposed upon, NHS England. That is increasingly where we should be aiming to arrive: at a combined thought.

What goes into value-based pricing matters enormously as well. The noble Lord, Lord Hunt, referred to some of the important aspects. First, it is about societal values. For example, if we can deliver a health gain among the parts of our population where health outcomes are poorest, then we should ascribe additional value to that health gain. A modifier for health inequalities is consistent, for example, with the statutory responsibilities of the NHS to seek to address and reduce health inequalities.

Unmet medical need makes a difference. Incremental effectiveness of medicines is important, but to have a medicine available for those who thought that there was no opportunity for treatment available to them from the NHS can make an enormous difference, and I think we should ascribe additional value to that. Medicines which deliver innovative benefits—for example, which have a whole new mode of action—can lead to subsequent treatments, and we should have a method of qualitatively understanding where those innovations, even if they may not have dramatic incremental benefits, none the less give us long-term potential. We should reflect that in the price that we are prepared to pay.

Indeed, as the noble Lord, Lord Hunt, said, we should not apply a discount rate to quality-adjusted life years that is directly comparable with the discount rates that are applied to revenues over time. I think people's time preference for quality-adjusted life years is not so dramatically higher for gain now as opposed to gain in the future; there is a much greater degree of equivalence between health gain now and health gain that people will derive in future. That would certainly assist in promoting medicines that slow the progression of disease and help us to manage longer-term morbidity in our older population, which would be immensely helpful.

There is a whole range of such matters and there are many more one could talk about, but it is really important to distinguish between NICE’s job in undertaking a health technology assessment, which I think should be moved from the purely quantitative to the qualitative. It should include, for example, relying not only on randomised control trial data but understanding observational data and the data we receive from the use of the innovative medicines fund to see how well medicines work and what benefits and outcomes they can deliver—sometimes in relatively small populations for rare diseases—understanding that in practice and incorporating it in its assessment.

We need to support NICE in delivering what is regarded internationally, I hope, as a gold standard of health technology assessment. We need to understand that that is separate and distinct from the business of what price the NHS should pay and on what basis the industry and we, as payers for new medicines, should agree, understanding that our objective must always be to ensure that safe, effective and high-quality medicines are available to the NHS and patients.

Baroness Thornton (Lab) [V]

- Hansard -

Copy Link

- - Excerpts

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.

Lord Lansley (Con) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I am very glad to follow the noble Baroness, Lady Bennett of Manor Castle, and prior to her the movers of Amendment 67. I welcome the fact that we have this opportunity to say something about redress. Amendment 68 is to follow in the next group, and I think it important to distinguish between the need to establish a scheme of redress where the NHS or government have been responsible for something which subsequently turns out to have damaged or harmed people, and the need to establish a scheme to provide proper support to those who have been harmed. That has been done on an ex gratia basis but, if the Government sought to do so, I think it would be possible to commence the NHS Redress Act 2006 and to establish such redress schemes under a statutory footing. It is not necessary to pass legislation to make that happen.

Those are different and distinct from the process of recognising that those harmed as a result of clinical negligence or failures in treatment processes should be able to secure a remedy and redress. I say remedy advisedly because often, in my experience of talking to people who have been harmed as a result of clinical negligence—these are often cases involving harm to babies during birth—it is as important to understand what happened, to accept where responsibility lies and to understand that others will not suffer in the same way, as it is to secure redress, compensation and support, which is often support for the child throughout their life. We need to understand that that is what we are talking about, not just the question of compensation.

I am slightly surprised by Amendment 67. I wonder what we think NHS Resolution is, if not an agency within the NHS with responsibility for securing redress for those who have been harmed as a result of clinical negligence. We need to recognise the need for, and I hope the Minister will tell us that the Government have not abandoned thought of, further reform. Certainly, when we were in opposition, we argued during the passage of the NHS Redress Bill that there should be a fact-finding phase. We argued that, rather than having an adversarial process with expert witnesses and all the associated costs, we should have a phase during which a claim is brought and the facts are established on an independent basis. That could lead to arbitration procedures and a settlement, rather than court-based proceedings, and we might escape some of the burden of cost. We should remember that nearly half the total cost of compensation in the clinical negligence process through NHS Resolution is actually legal fees. If we can escape some of that through an independent fact-finding phase, an arbitration process and financial settlements which recognise the support that the NHS and taxpayers give to those who have been harmed and have enduring problems and disabilities as a result, we might escape some of the burden of cost.

As the noble Lord, Lord Hunt, said, the potential contingent liability—not on an annual basis, but in the future—has risen to £83 billion. It is an enormous sum. The amounts paid by way of premiums to NHS Resolution are a significant aspect of the cost of NHS providers. There continues to be a good argument that the Government should consider this area still in need of reform.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

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.

Lord O'Shaughnessy (Con) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, it is a privilege to be able to support and put my name to the amendment in the name of my noble friend Lady Cumberlege. As has so often been the case in this Bill, where she leads, others follow, and I entirely endorse everything that she and the noble Baroness, Lady Bennett, have said. My reason for supporting the amendment is simple: as my noble friend made clear today, there are tens of thousands of women, men and their families who are suffering from the impact of licensed medicines and medical devices that have been wrongly used.

My noble friend’s landmark review gives voice to so many people who have been ignored for too long; that is what gives it such moral power and makes the force of its arguments so irresistible. Within the final report of her review is a clear recommendation for ex gratia redress schemes to be established for those affected by the HPT, mesh and valproate scandals. To my mind, this recommendation is neither radical nor extraordinary: such schemes have been set up in the past—for the victims of thalidomide and contaminated blood. Indeed, this is a common-sense proposal, and it is urgent—because the suffering of so many continues to this day, as my noble friend pointed out.

I have spoken in the past of two women—Janet Williams and Emma Murphy—whose lives, and whose children’s lives, have been changed for ever by in utero exposure to sodium valproate. They were interviewed as part of a recent Channel 4 documentary on the challenges they face in day-to-day life, the guilt they have been made to feel and their struggle to be heard. Janet and Emma’s honesty and tenacity have been an inspiration to me since I met them, and I defy anyone to watch that programme and not be moved to tears.

I was also contacted recently by another lady, who has been harmed by mesh. Her name is Susan Morgan, and, with her permission, I convey her story. She described to me being on,

“a hideous journey that was thrust upon me without consent”,

suffering grievous, painful and irreparable damage due to a mesh that can now never be removed. Sadly, she has lost nearly everything in dealing with the consequences of this terrible, avoidable injury, and she asks only that

“the burden of fear and worry be removed so that I can find some peace”.

Therefore, I ask my noble friend the Minister: are the redress schemes proposed in the review of the noble Baroness, Lady Cumberlege, under serious consideration, as my honourable friend Nadine Dorries said in the other place earlier this week? I hope so. If so, when will they be introduced? Only a robust answer will be enough to satisfy those supporting this amendment. I close by imploring my noble friend to move quickly: these victims cannot wait any longer—their pain is real, and their need is urgent. Of course, a redress scheme will not change or right every wrong that has been done to Susan, Janet, Emma and thousands like them, but perhaps it might bring them some peace.

Lord Hunt of Kings Heath (Lab) [V]

- Hansard -

Copy Link

- - Excerpts

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 Hunt of Kings Heath (Lab) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, it is a great pleasure to follow the noble Lord, Lord Patel.

What does one say to the people of Northern Ireland? They voted to remain in the EU, their vote was ignored by the DUP, and they have been duped by the Government, who continue to deny that there is a border in the North Sea—when today we are debating ample evidence of such a border. As the noble Lord, Lord Patel, identified, the distinction the MHRA is now having to make between the EU market, the British market and the market for Northern Ireland, as well as the bureaucracy involved and the cost for British-based companies, is undeniable.

These two very modest amendments seek to ensure that Parliament gets a regular report on how this is working in relation to medicines and medical devices regulations, and that various bodies should be consulted. However, over and above that, the Minister owes the House some explanation of how we have ended up in this bizarre situation, where Northern Ireland, which wanted to be in the EU and wanted to be listened to, has ended up in this rather parallel existence, with a border down the North Sea, food shortages in its supermarkets, and in a right mess. I hope the Minister can answer that.

Baroness Penn (Con)

- Hansard -

Copy Link

- - Excerpts

My Lords, we now turn to the way in which reports are prepared and made on the exercise of the regulatory-making powers in the Bill.

Amendment 69 in the name of the noble Baroness, Lady Thornton, would make changes to the existing requirement to report, introduced in Grand Committee. It proposes that an additional report be made by the Secretary of State to Parliament, this time on regulatory divergence with Northern Ireland introduced as a consequence of future regulations. I understand the noble Baroness’s intent. I heard the concerns raised in Grand Committee about the potential impact of regulatory divergence. The Government take that seriously. However, I will explain why this amendment is not necessary to address it.

As a reminder, the amendments made in Grand Committee provided for a reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 9(1) and 14(1)—one that was both forward- and backward-looking. Those reports must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. It will necessarily draw Parliament’s attention to regulations that have been made.

Parts 1 and 2 of the Bill relating to human and veterinary medicines are matters transferred to Northern Ireland. As such, legislative consent was secured for the Bill earlier in its passage, but as amendments were made during Grand Committee, further legislative consent was sought. At Northern Ireland’s request, government Amendments 75, 76, 79, 80, 81, 82 and 85 in this group replicate the existing reporting obligation for Northern Ireland. This means there will be a report laid in Parliament every two years on what new regulations have been made and any plans to make further related regulations. A separate report will be laid before Northern Ireland. Between our report and the report laid before the Northern Ireland Assembly, any areas of regulatory divergence between the UK and Northern Ireland regulatory regimes will be made clear. Therefore, it would be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for human and veterinary medicines and medical devices.

In addition, where there are concerns about the implementation of the protocol and its impact on patients and animals in Northern Ireland, there are formal channels in place. Officials meet regularly in the Ireland/Northern Ireland Specialised Committee. The Specialised Committee reports to the Withdrawal Agreement Joint Committee and provides advice on decisions to be taken by the Joint Committee under the protocol.

Before the end of the transition period, we raised with the EU through its specialised committee the issue of the falsified medicines directive and regulatory importation requirements for medicines moving from Great Britain to Northern Ireland after 1 January. We agreed with the EU a pragmatic one-year, time-limited approach to implementing these regulations that ensures no disruption to the flow of medicines to Northern Ireland. I say this to reassure noble Lords as to the effectiveness of those mechanisms under the protocol.

Noble Lords made a number of comments on the issue of regulatory divergence and I thought I would dwell on it briefly. The noble Lord, Lord Patel, gave a good description of future provisions regulating devices between Northern Ireland and Great Britain. He is wrong to say that the Bill lays out Northern Ireland separately because of this. It does so because medicines and veterinary medicines in Northern Ireland are the responsibility of the Northern Ireland Assembly and are therefore devolved. However, divergence may be an issue for the future, not least because the EU may change its own regulatory regime under the protocol that Northern Ireland will follow, and the UK may make changes here as well.

To reassure noble Lords, we have agreed a standstill period of two years for medicines and veterinary medicines and two and a half years for devices, during which we will continue to recognise EU regulations in these areas. This means that there is time for adequate consultation on regulations made under this Bill, for consultation on any future changes and for these mechanisms to operate properly. Divergence may be a matter for the future, but we have reporting to Parliament and public consultations on any regulations made under this Bill to address those questions.

The noble Lord, Lord Hunt, asked how we ended up here. I think that question is slightly wider than the purview of this Bill. I have quite a lot of lived experience of how we ended up here and I do not intend to recount that now.

I hope the amendments I have referred to in the name of my noble friend Lord Bethell, coupled with these other, existing arrangements, make the amendment tabled by the noble Baroness unnecessary.

Government Amendments 77, 83 and 84, also in the name of my noble friend, are made in the same light of expanding reporting obligations. In the interests of transparency and scrutiny, amendments have been made to extend the obligation to include regulations made under Clause 18—the regulation-making power in relation to the medical devices information system. We have made this change to make clear our absolute commitment to transparency, to giving Parliament continued visibility, to understanding the assessment made of any proposals or concerns raised as to how the regulations have been working, and to ensure that the regulation-making powers specifically containing provisions that may ensure or affect device safety and post-market surveillance are treated equally.

The noble Baroness, Lady Thornton, again seeks to test us on the preparation of the reports with Amendment 78, which would add a list of stakeholders to be consulted under the obligation. Again, this is unnecessary. If her concern is that the stakeholders listed may be ignored, I reassure her that the reports must summarise concerns raised, or proposals for change made, in relation to regulations enforced during the reporting period. That information will come from engagement with relevant stakeholders. Therefore, I do not think it necessary or proportionate to add a list of specific stakeholders to be consulted for each report, which will be a summary of public consultation that will already have been responded to.

I must say to the noble Baronesses, Lady Jolly and Lady Wheeler, that the Government will not return to this issue at Third Reading, so if they wish to press it, now is the moment. However, with the number of avenues already available, I hope that they are reassured that their amendment is not needed and will not wish to press it.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

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.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

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 Mackay of Clashfern (Con) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I would like to join in the praise that has been very well entitled from the many people who have spoken today, and at other times, in thanking the noble Baroness, Lady Cumberlege, and her team for the excellent report, which lies at the beginning of this development. I thank my noble friend Lord Bethell and his team for the way they have taken this forward, because I am conscious—I have tried to think about it quite a bit —of how difficult this has been. I feel that, apart from some questions that have been raised—which I do not seek to mention again as it would be useless repetition—the scheme that is involved in these amendments is very good indeed. I shall say one thing about it in a few minutes.

It is quite clear to me that safety in the NHS and in other services is an extremely important matter. When you see the amount of money that the Health Foundation pays out in respect of claims against the health service, it is fairly plain that it is a very serious problem, in fact, and one which has been found to be extremely difficult to reduce substantially. The money that goes out for these claims is a very substantial proportion of the total amount spent on the health service, so this is certainly a very important area, and it is important that it should be attended to in this way as soon as possible.

When I read the report originally, I felt that it revealed a very urgent and important problem in the health service, and that it was vital that patients should have a voice when damage emerged from a particular source, particularly where that source was in some general use. There can be no question but that this is a difficult problem and that it will take all the skill and command of the Government to produce a satisfactory and workable answer.

The report emphasises the need for principles to guide the commissioner and the wisdom of seeking the help of the public to enunciate them. I am very pleased that the Government have taken this on and that the Scottish Government have also indicated their hand to tackle this problem. Although health is devolved, it is important that, if it is at all possible, the answer to this question is agreed across the whole of the United Kingdom.

The title of the report is First Do No Harm. However, the report indicates harm having been done in a number of cases. Many treatments start with an incision and, sadly, some patients pass away on the operating table. In none of these cases do any of the practitioners involved intend to do harm. Surely this shows the calibre of the person required to take on this essential role. To enunciate the principles involved in patient care I consider to be an extremely important labour and a task demanding a person of tremendous responsibility.

I strongly support these amendments, subject to the questions that have been raised, and I am happy that they have been put forward so fully at this stage by the Government.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

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)

- Hansard -

Copy Link

- - Excerpts

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.

Lord Hunt of Kings Heath (Lab) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I must say that I very much disagree with the noble Lord’s remarks. If we want certainty, we need legislation that is well grounded and which has had thorough scrutiny in Parliament. The problem with this Bill is that it essentially gives a blank cheque to Ministers to change the regulatory regime for medicines and medical devices. If this was just to deal with the aftermath of Brexit, that, of course, would be understandable. But it was made clear in Committee and at Second Reading that the Government are wedded to this way of doing legislation. As the Minister said in Committee,

“this is a modern and fast-changing industry … we may still need to preserve our ability to amend and update regulations.”—[Official Report, 19/10/20; col. GC 328.]

The noble and learned Lord, Lord Judge, referred to two of our most distinguished Select Committees. We need to return to what our Constitution Committee said:

“This is a skeleton bill containing extensive delegated powers, covering a range of significant policy matters, with few constraints on the extent of the regulatory changes that could be made … The Government has not provided the exceptional justification required for this skeleton approach.”

As the noble and learned Lord, Lord Judge, has said, the Government have form. We are increasingly seeing the use of skeleton Bills and Henry VIII clauses. We really must come to a point where we say to the Government that we will not put up with this any longer.

I listened to the Minister in the last debate: what did he offer the House in respect of further scrutiny? It seemed to me he offered a debate or two, and that was it. The Government do not have an answer; they are refusing to budge on a principle which I believe is fundamentally wrong.

The noble Lord, Lord Naseby, talked with joy about the effectiveness of affirmative statutory instruments. This is nonsense. I think eight SIs have been defeated in your Lordships’ House in history; the last one led the Government to threaten to abolish the House of Lords. Unfortunately, the affirmative procedure is hardly any better than the negative procedure, and they do not allow this House to really exert any change on the orders going through.

We have to stand up on this matter. It is much more important and much wider than the issue of medicines regulation. I very much support the amendment moved so effectively by the noble Lord, Lord Sharkey.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

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.

Baroness McIntosh of Pickering (Con) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I welcome Amendment 5 and others in this group. I echo the noble Baroness, Lady Thornton, in complimenting both the Minister and the Bill team on their expert handling of this part of the Bill.

I find the sentiment behind Amendment 12 attractive and endorse entirely the words of my noble friend Lady Cumberlege and others who have supported her in wanting to avoid “harm”. The idea of a threshold, as solicited in Amendment 12, seems helpful. I have a question for my noble friend the Minister to which I would be grateful for a response. We are told in the explanatory statement that the amendment would require the Secretary of State

“to publish the criteria that will be used by the appropriate authority”—

obviously not yet set up—

“to determine whether the benefits of regulations that may impact on the safety of human medicines outweigh the risk”

and

“to allow for greater transparency and scrutiny.”

My noble friend said that the Government intended to publish the initial assessments. It would be helpful to know when that would be.

There currently seems to be a gap in the law; for example, as regards the vaccinations—I know that this was debated earlier today. The Government have unilaterally extended the time between the first dose and the second dose of Pfizer and AstraZeneca vaccines from three weeks—21 days—to up to 12 weeks. No other European country that I am aware of has done this. It is true that Denmark is looking to extend it to a maximum of between four and six weeks, which is nearer the initial three-week period. I presume that, if what is proposed by Amendment 12 were law, the Government would be obliged to publish the arguments in the interests of transparency, openness and scrutiny as to how they had reached that decision. If that were the case, I would be minded to support Amendment 12.

Otherwise, I welcome Amendments 4 and 5 and others in the group, which look to establish the overarching objective as being public health. I like the formulation of words that the Government have hit on and hope that they will stick with it. I shall be interested to hear how my noble friend responds, but, as I see it, there is some merit in Amendment 12.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

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.

Lord Hunt of Kings Heath (Lab) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, this debate follows a very interesting one in Committee, in which the noble Baroness, Lady Bennett, posed some searching questions about the potential for designing new drugs that are less harmful for the environment, whether in their composition, their impact when they escape into the environment, or in their packaging. Today, she also argues that the expectation of this approach should be built into legislation.

In Committee, the noble Baroness gave some very interesting examples. I was particularly interested to hear that in Sweden—

Lord Crisp (CB) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I am very pleased to add my name to the amendment in the name of the noble Baroness, Lady Sheehan. I shall be brief and limit myself to one central point, because the arguments have been put so well by noble Lords who have already spoken. At its heart, this amendment is about achieving the right balance between the public interest and private interests. In this particular context, it is clear to me that the Government should commit themselves clearly to safeguarding the public interest and to taking action on—let me stress this—those rare occasions when it will be necessary.

This is particularly vital, as other noble Lords have said today and on earlier occasions, because, sadly, there is a history of price gouging and exploitation of the public. There has also been lack of transparency and, of course, one should also note that the development of many treatments and vaccines have benefitted from public investment. I hope the Minister will be able to make the commitments that the noble Baroness, Lady Sheehan, has requested.

Baroness Wheeler (Lab)

- Hansard -

Copy Link

- - Excerpts

My Lords, I too congratulate the noble Baroness, Lady Sheehan, on another important speech on this key issue and the dogged way she has pursued her arguments and key questions to the Minister. I thank her for sharing her response letter of 7 January to the Minister, which clearly sets out the issues she is still pressing the Minister to address, and I am looking forward to the response from the noble Baroness, Lady Penn, on these matters. I also welcome the very expert and thoughtful contributions from other noble Lords both today and in Committee on this issue, drawing on their extensive professional and international experience and knowledge.

As my noble friend Lady Thornton made clear in Committee, we support this amendment. The reassurance from the Minister during Committee about the Government’s commitment to collaborating with public and private partners in the UK and globally to promote affordable access to vaccines and medicines for all is welcome. Also, we are grateful for their continued commitment to the UK’s obligations on the WHO TRIPS agreement and the DOHA declaration, which provide important flexibilities that support access to medicines and are especially vital during public health emergencies such as the Covid-19 pandemic that is so engulfing us today.

Noble Lords are right to underline the deep concerns of patient groups on the issue of fair and free access to medicines. I remind the House that the Royal College of Physicians, the Faculty of Pharmaceutical Medicine, the British Association of Dermatologists and other key stakeholders have called for a review of the processes for issuing sole manufacturing licences and consideration of the use of price control mechanisms in relation to costs of production to increase access to medicines at fair prices. The Government’s assertion that non-exclusive voluntary licensing provides incentives for developing new medicines and health technologies is not borne out by recent evidence on newly patented drugs, as the noble Baroness, Lady Sheehan, has pointed out.

On vaccines, and our participation as a country in the global sharing and effort, access to the Covid-19 tools accelerator COVAX advance market commitment needs continuing support from the UK and wealthier nations. The promise was for matched funding if the £1 billion target was reached by the end of last year. Can the Minister update the House on this, and what will be the UK’s contribution? Is there any further information on the role the UK will play in the WHO’s proposed Technology Access Pool, C-TAP?

Finally, on funding of research and development, a number of noble Lords raised the issue of the absence of analysis of, and data on, how much public and private money goes into the development of new vaccines and medicines. The Minister referred to the VPAS voluntary pricing scheme negotiated with the industry, which runs alongside the statutory pricing scheme, the NICE appraisal process and the commercial NHSI arrangements. The scheme is designed to support patient access to innovative medicines and expires next year, so these coming months will provide a crucial opportunity to commence a detailed review on how the research and development of medicines are actually funded. This would not only strengthen the Government’s negotiating position but lead to greater transparency in the UK’s future relationship with the pharmaceutical industry, which we all want to see.

Lord Alton of Liverpool (CB) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I start, as others have done, by thanking the noble Baroness, Lady Penn, and the noble Lord, Lord Bethell, for the way in which they have engaged with noble Lords such as the noble Lord, Lord Hunt, who has put so much work into this—along with the noble Baronesses, Lady Finlay and Lady Northover, and the noble Lord, Lord Ribeiro—in trying to draw our attention to the enormity of the depredations that have occurred in China through forced organ harvesting. It is very productive that, this evening, the Government have been able to come forward with an amendment that has been agreed with the sponsors of the Committee amendment, having listened to the argument. I am especially grateful, as others have been, to the noble Baroness, Lady Penn, for the way in which she has engaged.

I will come back in a few moments, if I may, to two other issues that I have raised with her but which are not included in this amendment. They concern consent and the equipment that could be used in the extraction, freezing and harvesting of organs in China, and the question of whether, if British companies were involved in the production of such equipment, there is anything that we could do to forestall that.

On consent, the noble Baroness, Lady Northover, mentioned that, thanks to the noble Baroness, Lady Penn, we have now seen the reports of the Human Tissue Authority of 2018 following its visit to the National Exhibition Centre in Birmingham to examine the plastinated bodies that had been taken there. These were corpses that had been put on public display—what the noble Lord, Lord Hunt, referred to as part of a sort of travelling circus. A second exhibition was held later in the year.

It was extraordinarily naïve—at best—that no more probing was done into the origins of those bodies or how consent could possibly have been given from unknown, anonymised sources. Of course, it leaves the question hanging in the air of whether these were people who had been executed—they probably had been. Sadly, we know that that is the fate of many people, whether they are Falun Gong practitioners or people from different denominational minorities or faith communities, including the Uighurs. We have heard much already this evening, as well as in the Statement from the Foreign Secretary, Dominic Raab, in the House of Commons this afternoon, about the plight of 1 million people who have been incarcerated because they will not conform to the diktats of the Chinese Communist Party.

It is extraordinary that such things can happen in the 21st century, but they are happening. That is why we have to be vigilant and do what we can to prevent the exploitation of people who are caught up in these circumstances. I think particularly this evening of a young woman called Zhang Zhan, who was arrested as a citizen journalist. She is a lawyer by background and had gone to Wuhan to investigate the origins of the coronavirus. She has been languishing in a jail ever since, for some of the time on hunger strike. We know that many dissidents—people who have spoken out against the regime—including lawyers, have been arrested, and some have disappeared, never to be seen again.

Therefore, it is crucial that we discover the origins of the bodies that are used in these sorts of exhibitions and displays, which I personally believe should be prohibited in their entirety. The idea that they can be paraded for macabre purposes should fill people with a sense of disgust. The anonymity of the cadavers should have made the Human Tissue Authority see that this was an issue that it should not just have turned a blind eye to. It is not good enough simply to say that we have a strong regulatory authority. We do: we have strong regulations, many of which came out following the scandal at Alder Hey in Liverpool. However, since then, we have failed to plug the loophole that I and others identified in 2018. We used that phrase—a loophole—in a letter to the Times, but it also appeared in an article in the Lancet. There was a loophole that needed to be filled when it came to organs and tissues from outside the United Kingdom.

The amendment goes some way to addressing that but I think that there also needs to be further regulation on the issue of consent. I also feel—and I would like to press the Minister on this—that we must do more about the export of equipment from the United Kingdom that could be used in forced organ harvesting. Maybe this could be done through export licence control. I noticed in the Statement to the House of Commons this afternoon and in the letter that has been circulated to Peers this evening by the right honourable Dominic Raab, the Foreign Secretary, that he talks about there being a review of export controls as they apply to the situation in Xinjiang. He says that these measures are among the most stringent being implemented globally to help ensure that supply chains are free from forced labour.

That is welcome, but how ironic it would be if, in stopping coming into this country things that have been manufactured by slave labour in Xinjiang, we permitted the export of things to Xinjiang and elsewhere in China that were being used in the extraction, freezing and transportation of body parts in order to enable China to promote one of the biggest organ industries in the world. The noble Baroness, Lady Finlay, was right to say that we also need to do far more about the phenomenon of people travelling to other parts of the world to take organs from others. That kind of organ tourism is something that the British Government need to do more about.

That is all that I want to say. I look forward to hearing the reply from the noble Baroness, Lady Penn.

Lord Collins of Highbury (Lab)

- Hansard -

Copy Link

- - Excerpts

My Lords, I too thank all noble Lords who put their names to this amendment. It truly reflects the cross-party concern on this issue. I pay particular thanks to my noble friend Lord Hunt and the noble Lord, Lord Alton, who have been absolutely persistent in raising this at every level. We have debated this not only on this Bill but in other debates in this House.

I thank the noble Lord the Minister and particularly the noble Baroness, Lady Penn, for the regular meetings she has had with noble Lords to listen to our concerns. The fact that they have both listened and acted is a reflection of the good work this House can do in not acting in a partisan way. We have put the issue first and delivered on it. I am also grateful to the noble Baroness for the way she has gone to the limit of this Bill’s scope. I recognise that the Bill’s scope has placed limitations on us, but it does not stop us speaking about and delivering on the political issue that my noble friend and the noble Lord, Lord Alton, have raised. I am particularly pleased to thank everyone concerned.

I will pick up a couple of points. One of the big political issues that started my noble friend’s concern was the exhibitions we saw. The idea that consent could be given by dead or dying prisoners in China is absolutely ridiculous. We should never accept it and should continue to ensure that we strengthen regulation in that regard. It will be ongoing work.

I also pick up a point that both my noble friend Lord Hunt and the noble Lord, Lord Alton, raised in Committee; in fact, we raised it at Second Reading. We named two companies involved in supplying organ-preserving devices to mainland China. This could explain how organs are being transported around China, supporting this obnoxious practice of harvesting organs.

I was pleased to read the statement made by Dominic Raab in his announcement that the Government will conduct an urgent review of export controls, specifically as they apply to the situation in the Xinjiang Province, to, as he said,

“make sure that we are doing everything that we can to prevent the export of any goods that could directly or indirectly contribute to human rights violations in that region.”

We have heard in our debates in this House that that is potentially going on, and I hope that the Minister will be able to respond that she will work with both the FCDO and the International Trade Department to ensure that the concerns raised today will be reflected the review that Dominic Raab has promised. I hope she will take that up and, as raised by both the noble Baroness, Lady Northover and my noble friend Lord Hunt, the China tribunal’s conclusions about the nature of the practice that has been going on and the fact that the Uighurs and Falun Gong practitioners are its main victims.

As we have said in many debates, the Communist Party of China and the Government of the People’s Republic have denied all claims about this, despite the evidence of the tribunal, and have relied on the WHO clearing them of wrongdoing. Of course, we know that that is because the WHO does not have an independent expert compliance assessment mechanism: it relies on the Government of China and the Chinese Communist Party simply saying that it does not happen. I know that the noble Lord, Lord Ahmad, has been consistent and persistent in raising this issue and it has been raised with the WHO, but I hope the Minister will be able to respond today that we will continue to raise it through the organ of the WHO.

In conclusion, I repeat what has been said by all noble Lords. The importance of this amendment is not simply the specific points of law that it will address. The most important thing the amendment and this debate tonight does is send a very clear message that we will not tolerate such appalling acts against humanity and will deliver for the people of China, not for the Communist Party of China.

Lord Hunt of Kings Heath (Lab) [V]

- Hansard -

Copy Link

- - Excerpts

I am sorry, I have had a very poor connection tonight. Can you hear me now? All I was going to say was this: we were privileged to have a discussion with the noble Lord, Lord Bethell, and his officials before Christmas. The impression I had was that this is regarded as a useful clause to be used at some point in the future when a clearer purpose has emerged. I do not think that this is the way we should go forward. Like the noble Lord, Lord Clement-Jones, I hope the Minister can give some assurances tonight about how this clause and the information stored will be used.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

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.

Baroness Bennett of Manor Castle (GP) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, we started this debate today with widespread plaudits to the Government for listening to very strong campaigns to have a patient safety commissioner. Indeed, the noble Baroness, Lady Cumberlege, who has been so instrumental in this, commented on the importance of that person listening to patients. We have to draw the parallels here because we have heard—as a community, as a society, and as a Parliament—from the parents of children who desperately need these medicines but are unable to access them. Those patients are not being listened to. We really do have to ask ourselves the question of why that is happening and what kind of political block or ideological barrier exists so that we are not seeing action in this area when it is so clearly, urgently needed.

When we were talking about a patient safety commissioner, I commented on how effective campaigning has been in that area. There is also a very effective campaign called End Our Pain, which has been working with families trying to access this medicine. It has been doing a great job, but the Government have not been doing their job in delivering on the campaign. I give credit to the noble Lord, Lord Field of Birkenhead, and all the other people who have signed this amendment, which is very much cross-party and across the House. As the noble Lord said, we have a division here—a human rights issue, referred to in the amendment tabled earlier by the noble Baroness, Lady Sheehan. People, or families, who can afford it, are able to access this medicine; those who need NHS support for it cannot. We should not be tolerating that situation in Britain at any time, particularly in 2021.

I have a direct question for the Minister. I have been looking at what assessment the Government might have made of the impact of current policies and the lack of financial support for vulnerable families. I should be happy to be corrected and perhaps told that an assessment is under way, but the most recent information that I was able to find was from September last year, when Liz Saville Roberts MP asked a Written Question in the other place about whether such an assessment had been made—and the answer was no. I will be brief, because the issues have been well set out by the noble Lord, Lord Field, and others. However, I ask the Government what assessment they have made of the impact of their current policies.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

The noble Lord, Lord Field, will know from this afternoon’s Question that I have huge sympathy on this issue, and I also completely recognise the frustration that exists around this subject. As I said earlier, “Come on, Prime Minister: if you can solve Brexit, in your own terms, I am sure that you will be able to solve this one, too.”

“Irresponsible” is not a word I would use to describe the noble Lord, Lord Field. He was very temperate in his introduction of the amendment. It is shameful, as the noble Baroness, Lady Meacher, said, that only three prescriptions have been issued properly by the NHS for free use. That means there is something is seriously wrong here. I thank my noble friend Lord Hunt, who is quite correct: this does require political muscle. The noble Baroness, Lady Bennett, is quite right, because this issue also completely exposes the inequalities we see in our society, whereby people who are fortunate enough to be able to afford to buy cannabis products can do so, while those who cannot, cannot, and then they suffer the consequences of that—literally. The noble Baroness, Lady Jolly, mentioned despair, and I agree with her.

So I do think that, as a result of this short but very potent debate, the Minister needs to commit at least to the meeting with the MHRA and the movers of the amendment.

Lord Flight (Con) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, it is politically healthy that the UK system has the ability to correct and polish statutory instruments, and that such changes made by government need to secure the approval of both Houses of Parliament. The House of Lords has a useful role in investigating and debating changes to the law made under the affirmative procedure. It is particularly useful that a large number of eminent lawyers sit in the Lords.

The two relevant key instruments currently being addressed reduce the self-isolation period from 14 to 10 days for people in England who have had close contact with someone who has coronavirus. This change also applies to the minimum period of isolation for households switching their support bubbles. The regulations also make changes to the starting date for calculating the isolation period. The Government made the changes following a review by the chief medical officers of the evidence on self-isolating. The regulations shortened the infectious period to 10 days after contact; it was defined as being low, although it was higher than the likelihood of being infectious after 14 days.

The changes to self-isolation period starting points in England were made to bring them in line with the rest of the UK. While there has been some professional questioning of these changes to the regulations, I observe that they have, in the main, been accepted as necessary and appropriate.

Baroness Bennett of Manor Castle (GP) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I make two points—the first on transmission. As the Minister made clear in his introduction, the SARS-CoV-2 virus is hideously out of control. As scientific knowledge has increased, the importance of aerosol transmission and the key place of the need for ventilation in prevention, and not sharing inside spaces, has becoming increasingly obvious, as the noble Baroness, Lady Finlay of Llandaff, highlighted.

It may not be the Government’s intention but the slogan “hands, face, space” places this crucial issue last on the list and appears to make it of lesser importance. There are people, some of whom I have encountered, who think they are safe if they wear a mask, even in a confined space with a stranger, when the science makes it clear that that is not the case.

Are the Government considering an enhanced, expanded education and publicity campaign to stress the importance of ventilation and not sharing space, perhaps utilising something like the excellent graphics produced by the Spanish newspaper El Pais, which clearly illustrates how the risk of the virus being transmitted in confined spaces is increased, and ways of reducing that risk?

Are the Government also considering rethinking the use of the term “Covid-safe”, particularly when applied to workplaces? Given aerosol transmission, risk can be reduced but not eliminated. Broader understanding of that can make us all safer.

Secondly, I ask about the Government’s long-term plans to provide maximum safety in the period when significant numbers have been vaccinated. Current evidence suggests that the vaccines we now have will not provide sterilising immunity and, therefore, vaccinated individuals will still present an infection risk. What plans are the Government making to redesign spaces and practices, look at ventilation, crowding and practical arrangements in schools, hospitals, prisons and other institutions, and in guidance provided to private companies, to minimise prevalence of the virus? They need to prepare and have a plan that would also make us safer from other infectious agents that we know present a continuing danger in this world scarred by the climate emergency and nature crisis.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

The noble Lord rightly alluded to the Better Health campaign, and I remind him that we did relaunch it yesterday. That went extremely well and got a lot of coverage. But there is only so much that government advertising can do; I do not think that we can advertise our way out of this problem. It is up to individuals to make their own decisions, it is up to GPs to give the support that people need and it is up to us as a society to accept that the health of the nation is important to its resilience and to its long-term health. Until those decisions are made, we struggle to make progress in this area.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

Yes, I am glad to be able to reassure the noble Baroness that ICSs will be instructed to take obesity as part of one of their primary framework objectives. In fact, that is a very good example of how ICSs will make a big impact on complex issues such as obesity and how that impact will be felt in far-flung communities such as those in Cornwall.

The Lord Speaker (Lord Fowler)

- Hansard -

Copy Link

- - Excerpts

Can we speed up a little, please? I call the noble Baroness, Lady Jolly.

Lord Bethell (Con) [V]

- Hansard -

Copy Link

- - Excerpts

I cannot go into details of commissioning guidance in this short Question, but I reassure the noble Baroness that, when it comes to family involvement, new guidance has been issued in response to the Joint Committee on Human Rights, which puts family involvement in any seclusion or restraint decision. That is an immediate development since the report in October.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

My Lords, I thank the Minister for the debate today. A total of 34 million people will be living under tier 3 Covid rules from midnight tonight after London, parts of Essex and Hertfordshire were placed under the most severe level of restrictions. My first question for the Minister is: what have been the criteria for deciding these tiers, and will the Government commit to publishing the rationale for their decisions?

It was noticeable during the Statement yesterday that the Secretary of State spoke with firmness and confidence when he announced the new restrictions and why he was making them, and spoke about the worrying new strain of the virus. It was only when he was pressed on the effect of, and scientific story behind, the Christmas relaxation that he became less sure. One has to ask why that might be the case.

Talk of acting decisively and boldly seemed to go out of the window. In its place came fudge and obfuscation, dither and blather. Professor Chris Whitty, when commenting on the Christmas rules, said:

“This is, in a sense, a limited relaxation which will have some impact on the upward pressure on the coronavirus.”

Well, yes. The Government’s answer seems to be to fall back on ‌the idea that this is all about “personal responsibility”—about the public taking a minimalist interpretation of the rules, not a maximalist one. The Health Secretary eventually gave a vague bit of concrete advice on Christmas, coming close to saying that we should self-isolate for a few days before meeting grandparents.

“The best thing you can do if you want to see elderly relatives at Christmas is to be extremely careful now about who you see”

was how he put it.

I therefore have to ask the Minister whether the Christmas relaxation is being reconsidered. What is the Secretary of State’s plan to keep people safe through Christmas and avoid huge pressures on the NHS in January? What is his plan to support an exhausted, underfunded and understaffed NHS through January to deliver the care that patients will need? Is he confident that our NHS will not be so overwhelmed in January that it impacts on the vaccination programme? Will the Government publish an impact assessment on their decision to allow a temporary relaxation that will allow three households to mix over the festive period?

This is a virus that, without adequate restrictions in place, spreads with ferocity. Case rates are increasing again, hospital admissions are climbing and the R is edging up. Last week, the England-wide rate was 159 per 100,000; now it is 188 per 100,000. That is a 20% increase. Across London, cases have increased by 30% and across the east of England by 36%. None of us is therefore surprised at the action that the Secretary of State took yesterday. Indeed, he was warned that tier 2 would not be enough to contain the spread of the virus in many places. It looks as though in some areas, such as Kent, tier 3 is not enough to contain the spread there.

Elsewhere in the country, tier 3 appears to be forcing the virus to flatline. Indeed, in the north-west it is trending down. However, overall, cases in the increasing areas are rising faster than those in the decreasing areas are falling. As things stand, we are heading into the Christmas easing with diminishing headroom. As my honourable friend Jon Ashworth said yesterday:

“The buffer zone that the tiers were supposed to provide is getting much thinner.”—[Official Report, Commons, 14/12/20; col. 25.]

London, like other parts of the country, will now suffer dreadfully from these further restrictions, which we support, but we think there are some serious problems. Businesses and livelihoods will suffer and there will be a cost to mental health and our NHS. The Minister has often praised Liverpool, but is not the biggest lesson to draw from Liverpool that people still struggle to isolate if they do not have the financial means to do so? The eligibility criteria for the £500 payment are still too tightly drawn: people need decent sick pay, people in some circumstances need alternative accommodation and people need help with their shopping and medicines. Surely, some of the £22 billion spent on test and trace could be reallocated to offer people adequate isolation support—as has happened elsewhere in Europe and the world?

Why is there still not a plan to make lockdown easy for people to do? Will the Government address the wide gaps that exist in economic support for the self-employed, for example? The IFS has noted that many would

“fall through the gaps completely”

and estimated that nearly two in five people with some self-employed income were excluded from the Government’s support schemes—this is not adequate.

I turn to the vaccine. Can the Minister update us on how many people have received the vaccine? Can he set out exactly when unpaid carers will be given the vaccine, given that they spend their time caring for extremely vulnerable people and could pass on the virus? I echo what my honourable friend Jon Ashworth said in the other place yesterday, when he asked whether priority could be given to those who are terminally ill to get the vaccine as soon as possible.

Can the Minister also explain what guidance is being put in place for autistic people, for example, in in-patient settings to go home for Christmas? Autism charities have warned that autistic people in residential care will have to isolate for 14 days when they come back from visiting their families—that is not fair on those who need routine and support. The Government must make their guidance autism-friendly.

The PHE report last month found that people with learning disabilities had a death rate 4.1 times higher than the general population, and this could be 6.3 times higher—what steps are being taken to protect them as infections rise? In November, the Minister in the other place said she was asking SAGE to review this report and make further recommendations; what is the outcome of that?

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

- Hansard -

Copy Link

- - Excerpts

My Lords, I am extremely grateful for the clear and thoughtful questioning from the noble Baronesses, Lady Thornton and Lady Jolly. Both of them are right: we are seeing a sharp rise in south Wales, London and parts of the east and south-east of England, which is making us rethink some of our approach to Christmas. We have seen a sharp rise in the virus across London, Kent, parts of Essex and Hertfordshire, and reports of a new variant. We saw the evidence of this starting in the 15 to 19 year-old age group and we have taken swift and decisive action but, unfortunately, more may be necessary. We know that this rise will be mirrored in hospital admissions, and it takes only a few doubling times to put pressure on the NHS. The noble Baroness, Lady Jolly, is absolutely right to question whether we have the resources in place to see such doubling take place over time. This is a trend we are seeing all over Europe, in countries such as Sweden, where nearly all the intensive care in Stockholm is currently in use, and even in Germany, where tougher new restrictions were announced over the weekend.

It is entirely natural that we look very closely at the Christmas relaxation, but I am not in a position to share any update on that this evening. The noble Baroness, Lady Thornton, asked: what is the Secretary of State’s plan to keep us safe? We have plans, and I will be glad to share them with noble Lords. However, may I just say a word about personal responsibility? The noble Baroness, Lady Thornton, put it well: it is up to each and every one of us to decide whether we will take a minimalist or maximalist interpretation of the rules. At the end of the day, it is a personal decision on what kind of risk approach one will take to Christmas. The SAGE advice has been published and it is clear. It does not make very comfortable reading for those of us with elderly relations who have been looking forward to seeing us, but it clearly states that we should be looking to spend time at Christmas with as few people as possible for as short a time as possible and, wherever possible, outside instead of inside. I am afraid to say that that will be what a responsible Christmas looks like for everyone. It is not something that the Secretary of State can ordain; it is, unfortunately, what the spread of the virus requires.

I acknowledge—the noble Baroness, Lady Thornton alluded to this—that the tier 3 regimes, particularly in the north of England, have had a profound impact. The behaviours of people in the tier 3 areas have been considerably amended, and that has seen a sharp reduction in the infection rates in those areas. It demonstrates that restraint works, and I take a moment to applaud all those who have played a role in that achievement.

On the vaccine, I will be very happy to provide an update on the special cases that the noble Baronesses alluded to. Both the case for unpaid carers and the case for the terminally ill are powerful, and we are listening carefully to them as they are made. However, the JCVI has put in its priority decision and that is what we are working to at the moment. Any further complications or refinements to that create profound operational challenges, but we are listening very sensitively to the case being made for the special cases.

I share the tribute of the noble Baroness, Lady Jolly, to the AstraZeneca team. The “Panorama” programme last night was a tonic for the soul during these difficult times, and I would recommend it to everyone.

As to the new variant to which the noble Baroness, Lady Jolly, alluded, the preliminary scientific judgment is that it does not at the moment show any evidence that it will escape either the vaccine or any other therapeutics that are targeted at Covid. That is always the natural concern in these circumstances; we are studying it very carefully indeed and will, of course, update the House if any changes do emerge. However, the new variant, which has been correlated with higher levels of transmissibility in Kent, does remind us that the threat of Covid is undiminished and we must remain committed to the restrictions in place to contain this horrible virus.

The Deputy Chairman of Committees (Baroness Pitkeathley) (Lab)

- Hansard -

Copy Link

- - Excerpts

My Lords, the noble Lord, Lord Wei, has withdrawn, so I now call the noble Baroness, Lady Jolly.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

My Lords, it is quite clear that the smaller first statutory instrument is a tidying-up regulation and I thank the Minister for introducing it. The other regulation is, as the Minister put it, about developing a private market for testing. The questions that have been addressed to him in this short debate will have told him that there are some concerns about how that works.

My first question is: why is the CQC not the obvious body to do this? What has led to it being the UKAS? The time it takes to be accredited does not seem that different.

That leads to my next question, which was raised by my noble friend Lord Hunt: what additional resources and staffing has the UKAS been given to carry out this new responsibility? I looked at its website. Obviously, it is a creditable and important body. I am not undermining it at all, but I am questioning it taking on this new responsibility, which involves more expertise and more funding. Because it is a public health issue we are talking about here—the spread of Covid—what are its responsibilities when somebody gets a negative result? What happens when someone is infected with Covid? I would like to know what responsibility is being placed on the UKAS for it to place on the private sector deliverers of this service when they test someone who tests positive for Covid? It seems absolutely vital that that person is placed in the test and trace system. Can the Minister explain to the Committee what the “trace” bit of this is?

The noble Baronesses, Lady Wheatcroft and Lady Altmann, raised the potential for fraud and testing scams. How will the Government make the public aware of the need for test providers to be properly accredited? Also, how will they ensure, as part of the monitoring and regulation, that the certificates that are issued cannot be falsified or sold on, and what are their powers to intervene if they suspect or it is reported that that is happening? It is inevitable that some investigative journalist or programme will indeed try to do that in order to test the system. If it is found wanting, it will be a very serious undermining of what should be safe private testing.

There are a number of commercial providers offering Covid-19 “fit to fly” tests in the UK. As other noble Lords have mentioned, Which? found that the costs varied considerably, from £60 at London’s Gatwick Airport drive-through test—the cheapest test—up to £214 at a clinic in London. Of course, for a family of four going on holiday, that is a significant amount of money. Is there an intention to cap the price of these tests to make sure that individuals and families are not priced out? I think it is important for the Minister to explain the link and relationship between public sector procurement of these tests and the private services. We now have a long list of procurement problems—to put it mildly—in the testing and tracing regime and possibly billions of pounds of public money have been wasted; we will find out. We do not want to add to that with this new regulatory framework.

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

- Hansard -

Copy Link

- - Excerpts

My Lords, the JCVI has laid out a clear prioritisation, putting great emphasis on those who are older—the over-80s—and those in social care. The vaccine will come to those who are shielded and living alone in due time. There are some practical issues with getting the current Pfizer vaccine: as the noble Baroness undoubtedly knows, it has to be kept in cold storage and comes in substantial batches, which are difficult to break up. The initial cohort consists of 6 million people—those over 80, and the health and social care workers who support them. As for future vaccines, those looking forward to being vaccinated should wait for a letter. Those letters are being organised through their doctors, who have access to a central database to ensure that the right prioritisation takes place.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

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

Baroness Wheeler (Lab)

- Hansard -

Copy Link

- - Excerpts

My Lords, I thank the Minister for the Statement. Yesterday’s great news about the Pfizer/BioNTech vaccine and the MHRA’s clinical authorisation was the breakthrough that we all hoped for. We on these Benches join in with the heartfelt thanks to the dedicated scientists and those who have taken part in the trials, testing and validation process. Coming with the absolute assurance from the MHRA that no corners have been cut by it in the speeding-up of the vaccine, and that safety of the public has rightly remained paramount, the news is especially welcome.

Hospital trust staff will receive the vaccine first. This is a massive logistical challenge given the size of the workforce, the temperatures that this vaccine must be stored at and the two doses needed. We understand that 50 hospitals are already set up and waiting to receive the vaccine. How many NHS staff are expected to be vaccinated by January? When will mass-vaccination centres start opening in our communities?

On care homes, today we have the reality of the difficulty of ensuring that the vaccine can be delivered safely and quickly to them, in the light of its low temperature requirements and because of the fragmented social care system, involving thousands of predominantly small providers employing permanent and often frequently changing temporary staff. The Joint Committee on Vaccination and Immunisation’s Covid-19 priority lists advises that care homes residents and the staff who treat them should be first in line to be inoculated. We now understand that only care home staff will be among the first to be vaccinated, travelling to an NHS centre. While this and readiness in parts of the NHS to administer the vaccine are welcome, can the Minister update the House on how the Government will ensure that in the rollout of this essential vaccine, that hopefully will help to protect thousands of care home residents, they do not find themselves at the back of the queue once again? Care home managers are demanding clarity over this issue and have warned of confusion and raised expectations among vulnerable people.

Overall, we have historic strengths with vaccination, but in recent years we have lost our measles-free status, and we know that vaccination rates can often be lower in poorer and more vulnerable communities. While Covid-19 has affected everyone, the burden of the pandemic has disproportionately impacted the poorest, who are more likely to die than the richest. Can the Minister ensure that there is a health equality strategy, so that black and ethnic-minority groups, and the poorest and most vulnerable, do not miss out on this vaccine?

I also make a special plea for unpaid carers. Carers UK is deeply disappointed that carers are not on the priority list for the vaccine in England. Can the Minister explain the thinking behind this by the JCVI or the Government? They were prioritised for the flu vaccine, as it was recognised that if they get flu, the loved ones they care for are at risk and cannot be properly cared for. As a carer myself, I am in touch with many local carers, who play a vital role in keeping older, disabled and seriously ill people safe during the pandemic.

On the supply of vaccines, the UK has promised 40 million doses by spring, which is estimated as enough to give the required two jabs to health and care workers and everyone over 65. Nevertheless, in the first few weeks of winter, our ability to vaccinate could easily outstrip supply. Current figures are that there will be 800,000 doses in the country within days, with several million more to follow in weeks. I understand that the jabs are being manufactured in Belgium. What assessment have the Government made of the impact of Brexit on importation? Can the Minister reassure the House that supplies will not be disrupted, deal or no deal? We all understand that the restrictions will remain in place for some time but in the meantime, if someone is vaccinated, will they still have to isolate if contacted by test and trace, or are they now released from that obligation?

The Government’s document, Community Testing: A Guide for Local Delivery, suggests that local areas can use mass testing as a freedom pass. What does this mean in practice? How will local areas enforce rules if some people are able to follow different rules based on their testing status? In the Commons yesterday, the Prime Minister suggested that people may want to take advantage of mass testing ahead of visiting their families this Christmas, but what does this mean for people in areas that do not have access to lateral flow testing? Needless to say, despite the approval of a vaccine the restrictions will need to remain in place for some time, and test and trace will be key. Can the Minister confirm that mass testing will therefore be rolled out in all areas in time for Christmas? What are the consequences of the Christmas exemption period if not?

We must not forget that the Minister’s Statement also announced the welcome news that family visits can now take place in care homes, subject to visitors testing negative for Covid-19. However, the increase in staff and resident testing, alongside the introduction of visitor testing, must be backed up by additional resources to make this possible. What extra funding is being made available to care homes to meet the costs of additional testing, cleaning, PPE and visitor administrations that they will incur?

Today’s focus is on the vaccine and how it will be distributed. However, for the record, in response to the Secretary of State, Matt Hancock, claiming that the process of vaccine approval has been one of the early benefits of leaving the EU, the MHRA has today made it clear that the process for developing and authorising the vaccine has been undertaken under the terms of European law, which remain in force until the completion of the Brexit transition period at the end of the year. In other words, Matt Hancock’s assertion is simply not true.

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

- Hansard -

Copy Link

- - Excerpts

My Lords, I am enormously grateful for that large number of thoughtful and nuanced questions, and I will try to cover as much ground as I possibly can.

I start by supporting the noble Baronesses’ tribute to the MHRA. It has played a complete blinder. It has quietly worked since January for this very moment. It has thrown an enormous amount of expertise, diligence and professionalism at the extremely challenging task of managing this vaccine authorisation, and it is to its massive credit that it has landed with an enormous amount of confidence and has been greeted so well.

The noble Baroness, Lady Wheeler, asked about EU law and exactly where we stand in terms of Brexit. She is exactly right that this authorisation was done under the terms of European law, and the carve-out that we took was indeed completely within the realms of European law. I pay tribute to the international collaboration that lay behind this vaccine—among the inventors, with their Turkish-German background, with the contributions of the German company that founded the vaccine and of the Americans, who have marketed and distributed it. In fact, the collaboration behind it has been global.

However, there is something British about it as well. In Britain, we have a long-standing commitment to research into infectious diseases, and that has created an enormously strong framework and foundation for the work that we have done. At universities such as Oxford, where the Jenner Institute is based, and Imperial, we have established a terrific international reputation for our work on infectious diseases.

The regulator, the MHRA, has gone about its work with an enormous amount of confidence and expertise. That has meant that it has been able to handle, in parallel, the clinical trials for efficacy and the reviews for safety. It analysed huge amounts of data in parallel in real time, so that it could turn around the authorisation promptly and confidently when presented with the final data.

The commercial effectiveness of the Vaccine Taskforce has been phenomenal. It has secured contracts for a large number of vaccines, which has meant that manufacturing has been able to take place in advance, and delivery of the vaccine, which is happening as we speak, is able to take place promptly. On the enormous amount of collaboration on the deployment of the vaccine, about which the noble Baroness asked, I pay tribute to colleagues in the NHS, NHSD, the military, and those in social care and logistics. There has been enormous collaboration across the piece.

The noble Baroness asked exactly what figures there are for delivery and when it is scheduled to take place. I am afraid that I cannot give the precise schedule, but I reassure her that, as soon as we know the precise timetable, we will publish it to give the confidence and reassurance to the public that, quite reasonably, they would like.

The noble Baroness is entirely right that social care is our number one priority. The prioritisation list from the JCVI is crystal clear. It also presents a big challenge because, as she knows, the Pfizer vaccine requires cold storage. It comes in units of more than 100 vials. We do not want to waste this extremely valuable vaccine, so we are having to work closely with social care colleagues and the NHS to ensure that workers and those in social care can receive it. That will be difficult, and I do not doubt that there will be problems, particularly, as the noble Baroness pointed out, with getting the vaccine to small units of social care. However, I reassure her that colleagues are working on that night and day and are very focused on delivering a solution.

The noble Baroness asked whether those who take the vaccine will need to isolate. Yes, they will, and that will have to continue for a while. The truth is that we do not know whether taking the vaccine will reduce transmissibility. Our suspicion is that it will, but until we have the clinical evidence that that is the case, we have to be pragmatic and ensure the safety of the public. However, we are working extremely hard on trying to resolve that issue, and I reassure the noble Baroness, care home managers and those who live and work in social care that they are at the top of the priority list.

The noble Baroness also asked me about delivery of the vaccine from Belgium. I reassure her that there are numerous fallback plans for all kinds of scenarios and that the transport arrangements for this valuable cargo have been thought through incredibly carefully.

The intention is not to roll out mass testing or community testing in every single local authority before Christmas. We are working with those local authorities that have stepped forward and that either are the most keen or have the highest infection rates, to ensure that the partnerships that we have in place develop really good best practice and that those directors of public health who are the most energetic have the resources they need to develop new models. That work is happening at pace and we get updates on it every day. It promises to be an extremely effective model for cutting the chain of transmission.

I pay particular tribute to universities, which have worked extremely closely with both the Department for Education and the department of health to ensure that there is community testing on campus, so that the migration home before Christmas is done safely and effectively.

The noble Baroness, Lady Jolly, is entirely right that apparently it is not very difficult to learn how to give an injection. I have been offered a training course, but I am not sure that anyone would actually want an injection from me. However, I reassure her that we have mobilised an enormous army of people to administer the vaccine. That includes those existing in the NHS and social care as well as pharmacists, who have stepped up massively and to whom we are very grateful, and it will include the return to service of many retired healthcare professionals, to whom we are enormously grateful.

As the noble Baroness pointed out, there is a pipeline of vaccines coming through, not least the British one developed at Oxford University in collaboration with AstraZeneca. I cannot give her a schedule on precisely when all of those will be delivered, but it is extremely promising that there are between half a dozen and a dozen vaccines on their way. It serves as an indication of how science has ridden to the rescue to help us out of this awful pandemic.

Regarding those who are either sceptical or refusing a vaccine, we are reassured that concerns about the vaccine are at present relatively low. We are engaging with anyone who has a concern about the vaccine with respect and in a spirit of dialogue to try to present the evidence in a transparent and reassuring way. That approach seems to have paid dividends, and I am encouraged that the British public will be stepping forward for the vaccine in very large numbers.

I reassure the noble Baroness that we have a massive social media campaign to engage the public. I pay tribute to the media teams in the department and the Cabinet Office, who have worked incredibly hard throughout the entire pandemic and have handled literally dozens of campaigns, often at pace, with enormous creativity and diligence—and have got sign-off from Ministers, which is no mean feat at times—under difficult circumstances. They deserve all our thanks and praise.

Lastly, on the noble Baroness’s quite important questions about isolation, she is absolutely right: isolation is key. There is no point in testing and tracing if you do not isolate. However, the surveys that she refers to are fragmented. I am not sure if some of the simple surveys actually tell the whole truth. In honesty, people’s response to isolation is probably more subtle than simple binary questions would suggest. We are beginning to understand that many who are isolating, although they may not have completely obeyed every strict command in the isolation protocols, have massively changed their behaviours, and we are looking at ways of supporting those people through civic and financial support and through our messaging to ensure that the isolation protocols are as effective as possible.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

The noble Baroness makes a fair point. The rollout of PrEP has reached a great many local authorities but not all of them. The funding for it, at £11 million, has made a big impact but it has not covered all the ground. We are aware that this funding package runs out next year and we are in active engagement with local authorities in order to find a new mechanism going forward before July, when the funding will change. That said, our commitment, as I said earlier, to the principle of PrEP and its impact on reaching our targets for transmission remains resolute. I look forward to being able to announce a resolution of this funding formula.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

The noble Baroness makes an entirely fair point. Access to PrEP is not as even as it could or should be. It is a very important tool in our fight against the transmission of HIV, and it is a programme that we support wholeheartedly. However, it takes time to roll out a therapeutic such as this through the entire healthcare system. We have focused its supply through sexual health units because they are the most thoughtful and reliable places for the kind of consultation and expertise needed for a delicate new therapeutic like PrEP. However, she raises a good point that perhaps this should be and could be updated.

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

- Hansard -

Copy Link

- - Excerpts

The noble Baroness, Lady Hoey, and the noble Lords, Lord Shinkwin and Lord Moylan, have withdrawn so I now call the noble Baroness, Lady Jolly.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

Perhaps I may say how pleased I was to see the noble Baroness, Lady Brinton, in the Chamber today, joining in our debates.

I thank the Minister for introducing these very important regulations to the House. I hope that he, like me, does not feel too second division, as the debate in the other place was opened by the Prime Minister and the leader of the Opposition, but I am sure that he and I can probably do more than justice to this subject. I think that his right honourable friend the Prime Minister might be feeling just a little worried at the moment because I gather that he had 56 rebels on the vote that has just taken place in the Commons.

This statutory instrument sets out that the Secretary of State must review whether each area that is part of tier 2 or tier 3 should continue to be part of those tiers at least once every 14 days, with the first review to be carried out by 16 December 2020, and review the need for each of the tier 1, tier 2 and tier 3 restrictions at least once every 28 days. The first review is to be carried out by 30 December 2020, so I hope that the Minister will have some Christmas. The shame of the statutory instrument is that it offers a binary choice. If this were primary legislation, we could really test the legitimate concerns in a way that we are not able to do this evening. The regulations will expire on 2 February 2021. I urge the Government to think very carefully about how the discussion on renewal, or whatever happens next, takes place. We are many months into this regulatory review; I think it is time that it ended and we had proper primary legislation.

The allocation of the areas of the revised tiers was announced on 26 November. As the noble Baroness, Lady Hayman, said in her very wise contribution, it has cemented the deep sense of divisiveness in the nation. The Government have published information alongside a Written Statement which sets out the rationale behind the allocations. Many noble Lords have already criticised that, so I will not go into detail on it. However, it means that tier 1, which had 23.5 million people in it pre-lockdown, now has 713,000 people, and tier 2 now covers 32 million people whereas it previously covered 24 million. So it is not surprising that people are concerned about where they have been put.

The new map of the three-tier system in England looks very much like a depiction of the north-south divide, and as Danny Dorling, the Oxford Professor of Human Geography, said on Saturday:

“What’s certain is that the key to understanding the map is the underlying social and economic geography of England. To understand the changing medical geography of this pandemic, you must first understand how the country lives and works”.

There is the rub. If the Government do not have a real understanding of how people live their lives, the conditions under which they work, the security or otherwise of their jobs, the adequacy of their homes, the transport they rely on, their relationship with schools and local facilities and their reliance on informal support networks, it is difficult to see how the current proposals and the ones that have gone before can work effectively.

The combination of vaccines, mass-scale rapid turnaround testing and therapeutic advances offers a way out of the current Covid-19 challenges in the spring and early summer, but in the meantime, restricting social contact is the only way of reducing the pandemic, protecting our National Health Service and allowing it to do its job, as my noble friend Lord Hunt and the noble Baroness, Lady Watkins, explained. We can see some success, and I applaud that, but the Minister needs to understand that many people believe that the success in getting the R rate down has been achieved despite the Government and not because of them. Why do we need to be still learning the lessons of being too slow?

It is of course welcome news that the R rate is below one, but today we learned what that means—and it does not mean that we can return to any sort of normal life. The news on the vaccines is of course tremendously good. Like others, I am allowing myself to hope that one day I will be able to see my sisters, nieces and nephews in Yorkshire and to hug people. I am also hoping not to have to queue for the supermarket, and maybe I will be able to sit at the same table as my noble friend Lady Wheeler in the Guest Dining Room, rather than sitting six feet apart at separate tables.

However, we have been here before: overpromising and underdelivering. As my right honourable friend the leader of the Opposition said, we are now on plan 5. The slowness with which we have entered these different plans is the reason why the UK economy has been hit particularly hard. As the OBR reported, a sharp slowdown in activity meant that the UK experienced one of the larger falls and that activity was then slower to recover.

The shame of this is that the Government learned none of the lessons from the first wave of the crisis and failed to listen to SAGE—or to Labour, when we argued for a two to three-week circuit-break to coincide with half term. Instead, we have had a longer national lockdown and the economy has taken a bigger hit.

It is therefore vital that the tiers work, and that the relaxation of Christmas does not lead to a further spike and lockdown in the new year. How could that be done? We have a few ideas. We need to end the topdown, centralised model of testing, tracing, isolating and supporting. Local teams with local knowledge must be put in charge, and they must be given the resources to do the job. We need to get rid of Serco and give the testing, tracing, isolating and supporting to our local teams. Frankly, if the Government have spent £22 billion on this and it is still not working, there has to be an alternative.

We need to ensure routine testing for all high-risk workplaces and high transmission areas for NHS and care staff, of course, but those in retail, hospitality and transport, teachers and pupils in secondary schools should also have access to tests whenever they need them.

Furthermore we need to overhaul the failing support for self-isolation, for both businesses and individuals. We need to support our businesses. The Government’s approach to supporting areas under local restrictions is fundamentally unfair and risks a gulf in support opening up across the country. The idea that the Isle of Wight should receive the same amount of support as Manchester is patently unfair.

Businesses are in the dark about the future of the furlough scheme, which is up for review in January. What will happen next? The Chancellor is still refusing to help millions of people excluded from his support schemes for the self-employed, despite having had months to plug those gaps.

What about our students? What will be the impact of their return home before Christmas? What is the Government’s assessment of the risk of students contracting the virus between having the test—which I hope will be available in the universities—and returning home? What steps are the Government taking to ensure that transport capacity is not overwhelmed by the numbers of non-socially-distanced travellers next week? It is completely irresponsible for the Government to leave tier 3 areas across the north and the Midlands in the lurch again.

What about Christmas? What is the scientific assessment of the risk that five days of relaxation will entail? I raised this matter yesterday with the Minister, and I am still seeking an answer. Covid-19 cases have spiked across Canada in the past month, since Thanksgiving and Halloween. On 12 October, Canada had 185,000 Covid cases. Only six weeks later that number has nearly doubled. Canadians and Americans alike are saying that the surge is proof that nothing is worth the risk. I would, therefore, like the Minister to address this issue: what will the cost of Christmas be in infections?

Does the Minister believe that the three-tier system provides for the necessary post-Christmas restrictions, or is a third lockdown inevitable? Given the prediction that cases will increase after Christmas, what plans are in place to prepare the NHS and safeguard services in the coming months, until a vaccine allows life to return to normal? Front-line resilience is already at a premium and will be critical over the next weeks and months, particularly after Christmas, especially if we do not wish to look back on those activities with very deep regret.

With regard to the amendments to these Motions proposed by the gaggle of Conservatives, I sort of feel sorry for the Minister. It is noticeable that yet again the Government find themselves under fire from their own side. As I have said at least twice to the noble Lord, Lord Robathan, he has form in being a Covid restriction objector and seems prepared to risk people’s lives instead of supporting them to do the right thing. This is my view of the noble Lord’s—

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

I thank the Minister for taking this Statement, and I look forward to discussing the regulations that will flow from it tomorrow, if they successfully pass through the Commons. Although we can see that cases are going down—and that, of course, is a matter for celebration and relief—we are still seriously in the pandemic. We still seriously stuck in what seems like an endless cycle of lockdowns, which have not been working.

The Government have again wasted the opportunity, over the past few months, to get a handle on testing, tracing, isolating and supporting. Once again the hospitality industry in many parts of the country will be absolutely battered. Once again jobs will be in further jeopardy. Once again our theatres are closed. Once again older people, disabled people and people with learning difficulties remain stranded in care homes without visits from their families. Exactly what will be the difference this time that will make people’s sacrifices yield a reduction in the infection rates? When shall we see testing in care homes, for example?

Reflecting on the debate in the Commons following the Prime Minister’s and the Secretary of State’s announcements last week, we see that all MPs of all parties were desperate for two things. They were desperate to understand the basis on which these decisions were being taken, and they were desperate to understand how their constituents might be able to move from, for example, tier 3 to tier 2, or tier 2 to tier 1.

As my honourable friend Rachel Hopkins MP says:

“The good people of Luton will want to get out of tier 2 as soon as possible, but the current resources provided to Luton Borough Council for the lateral flow rapid testing pilot are insufficient to enable it to provide the level of mass testing that is being described nationally. The contained funding—£8 per person—just will not cover tests for 10% of Luton’s population, as the funding also needs to be used for the wider covid response, including wellbeing support for vulnerable residents.”

She asked the Secretary of State, and I now ask the Minister here, to

“confirm that there are national plans to provide additional support and resources to expand testing if the intention to test close contacts daily is pursued”.—[Official Report, Commons, 26/11/20; col. 1012]

The news about the vaccine is the light at the end of the tunnel, but noble Lords must be well aware that we are still well into the tunnel, and probably will be for months to come. The only sure way to contain the virus is for people to obey personal rules and, most crucially, for us to have an effective and locally controlled test, trace, isolate and support system. We on these Benches have known this and have been asking, if not begging, for the last part of this deal for many months. Despite the Minister’s constant issuing of large numbers one way or the other, it is still not working as it should be. It is not surprising that confidence in the Government’s ability to deal with the pandemic is at a low ebb, much lower than in March and April.

Yesterday I heard the Conservative Rother Valley MP Mr Stafford say on television that he thought we were in trouble with this virus because people had broken the rules—in other words, let us blame the public. He was taken to task firmly by my honourable friend Naz Shah MP, but I have to ask the Minister whether he agrees with his colleague Mr Stafford.

When areas such as Bury and Trafford went into lockdowns in the summer, the Secretary of State promised that MPs would be involved in the decision. Has that commitment now been abandoned? Then Ministers agreed to involve regional leaders but, it has to be said, took exception to being challenged by Andy Burnham. What role do regional leaders now have in these decisions, or is the position really that the Prime Minister imposes from Downing Street restrictions on communities across the Midlands and north that will have huge impacts on the livelihoods of families and small businesses? What are the plans to alleviate the hardship that these rules will create? Leicester, Bury, Leigh and Heywood have been under a form of lockdown for months, with families forced to part and grandparents not seeing their grandchildren. Those families will want to know today what the exit strategy is and what voice they have in that strategy.

The Secretary of State in this Statement has outlined five criteria by which local lockdowns will be judged. Will that be published, with clear, transparent rules for areas entering and leaving tiers and a scorecard for every area, assessing its Covid progress against its criteria so that everyone can judge this in a transparent fashion?

What have the SAGE advisers said to the Minister about the risks which go with the proposed lifting of restrictions for Christmas? The Canadians have a very clear message about this. They say, “Stay home and stay safe”, and the reason they say that is because the worst surge in Covid-19 they have ever experienced followed six weeks after their Canadian Thanksgiving. They have given warning to their southern neighbours—the United States—that they will see an even bigger and more devastating spike following their annual gathering for turkey and gratitude at Thanksgiving. This is a warning that we need to heed. Does the Minister agree?

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

- Hansard -

Copy Link

- - Excerpts

My Lords, I thank the noble Baronesses for their thoughtful and searching questions on an important day’s traffic of announcements from the Government. I would like to try to tackle them as comprehensively as I can, but I assure both noble Baronesses that I will write to them on any points I fail to address in these comments.

The noble Baroness, Lady Thornton, started by saying that she felt the endless cycle of lockdowns had not been working. It is undoubtedly true that we all regret the return to a national lockdown earlier this month, but it is not true they do not work. New infections are down by a third, and that is an enormous achievement by the British public, whose discipline and obedience to the restrictions has yielded a massive dividend.

The noble Baroness said that test and trace was not working. It is undoubtedly true that when prevalence levels are so high, when there are more than half a million infections in the country and when new infections are running at five digits, it is extremely challenging for any national testing and tracing system to keep up with that sort of capacity. I beg the noble Baroness to give some ground and acknowledge the achievement of the huge scaling of the number of tests, the vast number of people who have been asked to isolate, thereby breaking the chain of transmission, and the hard work of those who work on the tracing side of the business, which has dramatically increased its performance and will continue to meet target numbers.

The noble Baroness also talked about care homes being stranded. I remind her that we have come a huge distance. I could reel off a dozen achievements in the care homes strategy, but two stand out. First is the regular testing of staff, which has now become a systematic programme that has massively protected those in care homes. There has also been the recent introduction of testing for visitors, which brings welcome relief for those needing to support and visit those in care homes, a much-valued service that needed a huge amount of work to put into place.

The noble Baroness talked about the role of the public. I have alluded to my respect for and thanks to the public. I will be crystal clear: the challenge that we face as a country is not public apathy but the virus itself. There is an absolutely vicious aspect of the virus, which is its high contagiousness. In a room with a few people together, it is quite unlike most contagious diseases in its infectiousness. When we talk about the challenge of social distancing and the need for lockdowns, it is not one another whom we blame: it is the virus itself. I encourage all those who feel frustrated to remember who the enemy is.

The noble Baroness asked whether the tiering allocations would be done in consultation with local authorities. The brief answer to that question is no. We tried that, but it did not prove a successful experiment. The acrimony and large amount of delays created long-standing problems for the implementation of the policy. Therefore, we will be implementing the tiering on a fortnightly basis from the centre. It is a big yes, however, on the approach to community testing and infection control. We absolutely want to work in partnership with local authorities and local DPHs, which have all the powers that they need to decide whom they seek to target and what incentives they would like to provide for those who need to be attracted to testing. I also say yes—absolutely—to transparency, both in terms of the publication of the numbers and our approach to our collaborations. I put on record our massive thanks to local authorities, particularly those that have been working with us over the last fortnight on our community testing programme, the publication of which earlier today is a really important framework of the local-national partnership of which I have spoken at this Dispatch Box many times. It really brings alive that commitment.

The noble Baroness, Lady Jolly, was entirely right that there was an influenza plan, but it envisaged a completely different type of virus. The lessons from the influenza plan, though relevant for the kind of flu envisaged, were not applicable for the coronavirus. A good example of that is the PPE. Had we followed the possibility of preparing a massive stock of PPE for the kind of flu envisaged in the influenza plan, we would have had the wrong kind of PPE. There was nothing that we could have done about that.

The other big learning was on mortality rates. The mortality rates for Covid-19 and the long-standing effects that it has on people are completely unlike those of the kind of flu that we were envisaging earlier. It has been a grave learning curve to have to change our plans to deal with Covid.

In relation to other learnings or things that we have moved on since then, I reiterate a theme that I have mentioned before: our commitment to national and local test and trace. Quite understandably, the noble Baroness challenges me on that point, but I gently remind her that, in February, local authorities did not have any tests; nobody had any tests. We were doing 2,000 tests a day. Therefore, it is all very well saying that we should have left test and trace to local authorities, but there simply were not the resources there to do that. It took a massive national programme and huge national effort to get us up to half a million tests a day, which is something that the local authorities, even in collaboration, could not possibly have done.

The local authorities also did not have scalable tracing capacity. The PHE capacity was designed for ultra-low prevalence rates—for when you are chasing a few dozen carriers of a disease who, perhaps, have recently arrived from overseas. It was not designed for 20,000 infections a day, which is the kind of infection rate we have been looking at recently. It was only by building the data systems, protocols and guidelines, and having tens of thousands of employees, that we have been able to put that tracing capacity in place.

We also did not have the organisational or analytical capacity to do the kind of surveillance that is done through ONS and REACT or the kind of data management that the JBC has done. Now that we have those components in place—the physical, data and diagnostic frameworks—we are in a position to work as a team, both nationally and locally. The noble Baroness is entirely right that that local insight, intelligence, empathy and leadership are absolutely critical for our success, and I encourage her and all those in the Chamber to read our community testing programme, which was published earlier today and which encapsulates the spirit of the local-national partnership of which the noble Baroness has spoken previously in the Chamber.

The noble Baroness challenges me on communications, and I will not deny that it has been one of the great challenges of the pandemic to try to explain, in a fast-changing and confusing climate, the government imperative and recommendations to the public. One of the key things that we have learned is that, sometimes, the desire to share the delicious complexity of the epidemiology stands in the way of simple communication. Sometimes, trying to find the exemptions that are fair to everyone and cater to every single consultative recommendation stands in the way of simplicity, straightforwardness and tractability.

We have learned that, sometimes, it is more important to be simple, clear and straightforward than to try to accommodate every nuance and exception. This is why we have pursued rules like the rule of six, have gone for a simple and easily understood regional tiering process and applied the 10 pm curfew, although we have updated that to an 11 pm curfew, with a drinking-up time of 10 pm. That kind of consistent messaging is what the public, quite reasonably, respond to, which is why we have moved to it.

In response to the noble Baroness’s question about under-12s, I say that there are both the communication and epidemiological reasons that children are vectors of disease. This is an uncomfortable truth because they very infrequently show any symptoms and it is incredibly inconvenient—I say this as someone with four children, three of whom are under 12. However, it would be epidemiologically irresponsible to try to make an exception in that way, and I certainly will be spending quite a lot of Christmas with my family.

In relation to hardship, the noble Baroness makes the point extremely well, and we are totally sympathetic to her point. It is undoubtedly true that the least advantaged will be the hardest hit by this epidemic. It is true because their jobs are hit hardest, particularly those in casual labour, because the virus often hits those who have the most cramped accommodation or low-quality health and because many of those who live on the borderline of life will be the ones nudged into poverty.

The Government have worked hard, with the furlough scheme in particular, to ensure that a financial safety net is put into place, but I have no doubt that there will be a moment when the economic hardship created by the pandemic will be acute, and I have no doubt that the mental health implications of that for the population will be extremely hard. The Government are extremely aware of that and we are trying our hardest to minimise the impact. One reason why we are hitting the virus hard with these tiers is to ensure that we can get the economy back as quickly as we can, mostly to the advantage of those who are hit the hardest.

The noble Baroness asked me about entry and exit points to the tiers, and I have no easy solution for her. There are very clear considerations which we will be looking at when we consider which regions go into which tier: case detection rates, particularly of those over 60; the rate at which cases are falling; the positivity rate; and pressure on the NHS. But this is an incredibly complex matrix of interdependencies. It is not simple to plop it into the kind of easy algorithm that can churn out an answer at the push of a button; nor is it easy to have one simple metric where we can say, “You’ve hit this and therefore you move this way,” or “You’ve failed and you move that way.” If it were so easy we would publish it. The best advice we can get is that we have to consider all those factors when making those decisions. We will do it in a spirit of transparency, but we will have to make tough decisions. I reassure noble Lords that it will happen every two weeks, as the Prime Minister explained, and we will seek to be as fair and thorough as we possibly can.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

I hear the noble Lord’s words loud and clear. I reassure him that the good news is that Tessa Jowell left behind her in the Tessa Jowell Brain Cancer Mission an incredibly effective organisation that is holding the feet of Ministers firmly to the fire —not least through my noble friend Lord O’Shaughnessy, who is on my case in a very big way.

I recognise that this is one of the tricky scientific challenges of our age. We have struggled to tackle adult brain tumours for a very long time. There has to be investment in the basic science around them, in the techniques, such as the very focused radiology, and in provable therapeutics that work in the field. This is not going to happen overnight, but I reassure the noble Lord that we are committed to finding a solution.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

My Lords, I have a table of all the brain tumour research projects that we have backed over the last 10 years and I would be very glad to share it with the noble Baroness in correspondence. The short answer is, not enough. I would like there to be more grants and of higher value, but I recognise the challenge. When I speak to the scientists—even Richard Gilbertson, who is a very measured practitioner in this area—they recognise that more work needs to be done at an earlier stage to ensure that they are the kinds of projects that the NIHR system can back. We need to have a conversation about how we can encourage the early-stage science and the creative drafting of fresh ideas for that pipeline. That is something that I am very keen to get on with and have a dialogue about.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

My Lords, I am grateful to the noble Lord for referring to my calls. I would have made a lot more than 300 calls then, because those were extremely difficult times. I would remind him that the NAO report says that we found Ministers had properly declared their interests, and we found no evidence of their involvement in procurement decisions or contract management. Ministers were not involved in procurement decisions; they facilitated the introduction of potential suppliers at a time when there was a massive global crisis. Supplies to this country were being abducted by other countries, supply chains had broken down, the channel tunnel was constrained and the Indian transport system had ground to a halt. Presidents were literally diverting planes in the air with supplies meant for one country and grabbing them for their own. In those circumstances, Ministers and their advisers intervened to get the right supplies to the front line to help those seeking PPE. Those were extremely energetic efforts. I am extremely proud of that work. Procurement decisions were left to civil servants.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

My Lords, there is a very clear code for special advisers. They have line management through the Secretary of State and often on to Downing Street. The role of spads during the pandemic has been exceptional. I pay tribute to the large number of spads who made a huge difference, and I am very proud of the work that they have done.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

I am grateful to the noble Lord for highlighting three calls to suppliers. I should like to reassure him that those were absolutely exceptional times, when our supply chains had broken down and we were competing with other Governments for extremely scarce resources. I personally did not make three supplier calls; rather, I made 300. I put out literally hundreds of calls on behalf of the Government to try to find the medicines, supplies, diagnostics, PPE and all manner of medical requirements needed for this country. I could have done that only with the help of the networks, energy, skills and support of those who stepped forward to help us at our time of need. I repeat, I am extremely grateful for that support. It does not warrant a place on the front page of the Sunday Times but the lack of follow-up from that newspaper article speaks for itself.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

I take this opportunity to thank the very large number of Members of this House who contacted me during that period. My inbox was filled with thousands of emails every day, including emails from Lib Dem, Labour, Cross-Bench and Tory Peers, all of them seeking to help us during our time of need. I sought to reply to as many as I could, but I fear that I did not reply to enough and I did not mean any discourtesy. I spoke to a large number of those people, as my transparency register makes very clear. The telephone call on 6 April to which the noble Baroness has referred was not in any way inappropriate. I am extremely grateful to all those who stepped forward to help us when we needed it.

Baroness Masham of Ilton (CB) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, Amendments 100 and 101 make clear that there should be means by which patients can report into registries directly so that they can be heard even if there is divergence of opinion with their clinician. Patients need to be protected. I support all the amendments in this group and thank those who tabled them, giving extra thanks to my noble friend Lady Finlay, who works so hard.

This is exceedingly important for many patients who have rare and complicated conditions. I speak from experience, as a high-lesion paraplegic. Many GPs and general doctors or surgeons may not be familiar with several of the peculiarities and may not understand the patient’s needs. For people with spinal injuries, for example, the three Bs are very important: bowels, bladders and bedsores. If not treated by specialists, patients can get into serious problems. Severely disabled people use all sorts of complicated devices that need to be kept on a register and to be easy to track if they go wrong. Suitable mechanisms should be found for the variety of needs, which can be inside and outside the body. This is particularly difficult in this time of Covid-19.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

My Lords, this group concerns the need to set up information systems—registries—which will serve the purpose of tracking medical devices. I thank the Minister and the Bill team for their very enlightening and useful presentation this morning. The noble Baroness, Lady Finlay, and other noble Lords have already explained to the Committee how these registries and databases might work. The key point, which was made by the noble Baroness, is that they should be mandatory rather than permitted. Changing “may” to “must” so that the Secretary of State has to produce the information system envisaged by Clause 16 is a small but vital change. The Minister will need to explain to the Committee why, at this stage and after the experiences expressed and covered in the report of the noble Baroness, Lady Cumberlege, there should be any discretion in this matter.

The other amendments seek to ensure that patients have a direct route to report their experience to any information system established. Again, after the dismissal of so much patient experience over so many years in the cases outlined in First Do No Harm, it would seem to be the only way to guarantee that patient experience can be heard and registered.

Amendment 96 in my name is a probing amendment which seeks clarity about whether the Government intend to track all medical devices used in the UK, or just some of them. As other noble Lords have pointed out in the course of this Committee, if supermarkets have the technology and wherewithal to track the provenance of every single food product from anywhere in the world, we would need to understand why this would not be possible for medical devices.

Amendment 107 specifically addresses the issue of surgical meshes, and requires the production of a registry for patient safety. I hope that the Committee will be seeking to discuss registries and how they are linked. On Amendment 104 on the Caldicott principles, I do not see how anybody could possibly object to that.

Baroness McIntosh of Pickering (Con) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I support in particular Amendments 105 and 127 in this group, but I shall speak briefly to Amendment 105 and thank the noble Baroness, Lady Wheeler, for introducing this short debate on it. In the context of the proposal for a requirement to consult the devolved Assemblies, I share the concern expressed by my noble and learned friend Lord Mackay of Clashfern: it is essential that we keep all the devolved Assemblies in tune with Westminster thinking as the Bill and the regulations under it progress.

Lord Bethell (Con)

- Hansard -

Copy Link

- - Excerpts

My Lords, Amendment 105, tabled by the noble Baroness, Lady Thornton, would mandate consultation with the devolved Administrations before making regulations under Clause 16. This question has been raised by a very large number of those who have contributed. Amendment 132, also tabled by the noble Baroness, would insert after Clause 41 a separate obligation to consult on regulations made under the Bill that relate to matters within devolved competence.

Both amendments are unnecessary. It goes without saying that we will consult the relevant Northern Ireland departments where it may be possible to make regulations jointly under Parts 1 and 2 of the Bill for the benefit of the whole of the UK. I reassure the noble Baronesses, Lady Jolly and Lady Masham, and all others who mentioned consultation with the devolved assemblies that we are in very regular contact. There are fortnightly four-nations calls. These include NHS Digital where necessary. We intend to maintain this level of engagement. It has proved constructive and has contributed enormously to our plans for broad consultation on the mechanics of the Bill.

While medical device regulation relates to reserved matters, the provision of healthcare services, including the healthcare data collected, is devolved. As the regulations about the establishment and operation of the information systems encompass both areas of responsibility, it is right and proper that the Secretary of State is required to consult the devolved Administrations before making regulations under Clause 16(1).

The noble Baroness’s amendment appears on the list before my own, but Amendment 126 in my name, which I will come to shortly, is appropriate for this situation. It makes it very clear that the devolved Administrations will be consulted on regulations to be made under Clause 16. This reflects that provisions in those regulations may relate to devolved as well as reserved matters.

Amendment 127 in the name of the noble Lord, Lord Patel, is unnecessary. My Amendment 126, which I will come on to shortly, would apply a statutory duty to carry out a public consultation precisely because we know how important it is for patients and other stakeholders to be involved. The intent of Amendment 127 is already achieved by Clause 41 and is further clarified by the government amendment.

Amendments 128 and 129, tabled by the noble Baroness, Lady Thornton, and the noble Lord, Lord Sharkey, would commit the appropriate authority to consult all those listed before making regulations under the Bill. We all wish to ensure that a range of views are adequately captured. However, we do not wish to inadvertently rule out contributions from those accidentally not listed. Those listed in the amendments would not necessarily be directly affected by each regulation. For example, regulations relating to human medicines prescribing would not affect veterinary medicines. I reassure the noble Lord and the noble Baroness that the consultations will have depth and reach, and that medical research charities will be fully involved. Requiring consultation with all those listed would be unduly burdensome and seemingly add little value to the making of regulations.

On Amendment 130 in the name of the noble Baroness, Lady Thornton, I completely understand that there are perhaps some concerns with the extent of consultation, or, indeed, its duration, or that the Government might seek to consult on proposed regulations without sufficient notice to those wishing to comment. This is simply not the case, but limiting us in this way may hinder the delivery of important regulations coming into force. If the Bill were to be significantly delayed, it would mean that we could not make an efficient start on consulting stakeholders on key policy areas, such as on a future regulatory system for medical devices.

Whether consultation is conducted prior to the Bill achieving Royal Assent or afterwards, we will make it clear to stakeholders when the consultation processes will start and end. Consultations will be targeted, form part of a process of engagement and last for a proportionate amount of time. For my part, I cannot wait for the process to begin. It is very exciting.

I know that noble Lords want to know our plans for consultation, as do I, and when precisely that will begin. I reassure my noble friend Lady McIntosh that we will publish responses to consultation. We will follow the Cabinet Office guidance, which is extremely stringent. I am incredibly enthusiastic to reach that next step and to begin to make changes to the regulatory regime to deliver a comprehensive, stand-alone and first-class medical devices system, as well as to consult and have the benefit of informed views, like those of the noble Lords, Lord Kakkar and Lord Patel, among others, when we discussed provisional rapid licensing.

I want to make changes to the clinical trials regulations and to consult on how we can make improvements and update definitions. Also, of course, I want to bring in the medical devices information system regulations so that we can establish a world-leading medical devices safety regime. I indicated the intention to consult in the first quarter of 2021 on the innovative medicines fund. We intend to start public consultation on the medical devices information system in May 2021. We also hope to take forward the medical devices regulations consultation over the summer of 2021. There is obviously sequencing to do on all the other measures that we will want to bring in. I will update the House on our consultation plans in due course. The dates are dependent on getting the Bill done, of course.

As to Amendment 126 in my name, I heard the noble Lord, Lord Blencathra, ask at Second Reading how Parliament could be consulted on regulatory changes. Others reflected on the importance of consulting patients on the regulatory changes that impacted or mattered to them. I know that there has been concern about whether the relationship to the pharmaceutical and medical device industries is such that they might be unduly weighted in consultation, but I assure noble Lords that that is not the case.

To provide reassurance, Amendment 126 changes the obligation in Clause 41 to public consultation. The effect of the amendment would not be to prevent the appropriate authority from inviting responses from certain stakeholders or groups as the authority might consider appropriate. Engagement and close working will continue, but Amendment 126 will ensure greater transparency and enable even more people to become involved in the consultation.

The duty to consult the devolved nations on Clause 16 has been the subject of ongoing conversations and correspondence between Ministers in the devolved nations and me. I spoke earlier about the nature of these regulations relating to both reserved and devolved matters. Specific considerations will need to be taken into account in relation to how the devolved healthcare systems function and we want to ensure that any information system that we create is as effective as it can be. The information system will provide an important tool for improving the safety of medical devices for patients throughout the four nations of the United Kingdom. It has always been our intention to consult fully the devolved Administrations on the development of the regulations. I am making this change to provide greater reassurance and confidence, both to the devolved nations and to Peers who have raised the significance of ensuring interoperability between any such information system and devolved healthcare systems.

The final change made to Clause 41 by Amendment 126 will mean that participants engaging with the consultation can understand how the considerations have been taken into account so far. This additional transparency will, I hope, provide noble Lords with assurances that we have taken the criticisms on board and have provided a method for Parliament, the public and stakeholders to know how our thinking progresses throughout the development of regulations made under the Bill.

The combination of these changes strengthens the consultation requirement in the Bill. I hope that, taken together with amendments that I have made elsewhere in the Bill, it goes some way to meeting your Lordships’ concerns and that the noble Baroness will feel able to withdraw her amendment. I commend my Amendment 126.

The Deputy Chairman of Committees (Baroness Fookes) (Con)

- Hansard -

Copy Link

- - Excerpts

I next call the noble Baroness, Lady Jolly, and I dare say that there will be a little pause before she speaks.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

I am very grateful to the noble Lord, Lord Patel, and the noble and learned Lord, Lord Mackay of Clashfern, for bringing these amendments to the Committee. They are quite different, although linked. On Amendment 108, which would place a duty on the Secretary of State to

“disclose information … about concerns relating to a medical device where there is a clear threat to public safety”,

the noble Lord, Lord O’Shaughnessy, absolutely got it when he said that this is not a “may” but really is a “must”. The thing about this that would interest me most, because it is an important duty, is how it could happen: what would trigger such a disclosure, where would it come from and how would it be handled?

The only thing I would ask about this issue is whether a Secretary of State is the right person to do that. I have in mind someone who is now a respected noble Lord of this House, who fed his daughter a burger to show us that beef was safe during the BSE outbreak, which led to the creation of the Food Standards Agency as an independent organisation that would say, “This food is actually unsafe”, to the Government. It quite rightly has the powers to bring about a closure or recall. This is exactly the right place to be on patient safety. The only question I would pose is: is that the right person to do it?

Amendment 114, on Regulation 3B, worries me enormously. I would need to have an explanation from the Minister as to why he would remove confidentiality and seemingly protect commercial interests. It is very worrying, and the Committee needs to know the justification for that because it looks to me like it probably needs to remain in place.

Baroness Bennett of Manor Castle (GP) [V]

- Hansard -

Copy Link

- - Excerpts

My Lords, I can only begin this contribution, as I did at Second Reading, by paying tribute to the power and importance of the report by the noble Baroness, Lady Cumberlege, as so many other noble Lords have. I also note that the length of the list of Peers speaking to this amendment reflects the fact that this is perhaps the most important element of her recommendations, or certainly the most easily and directly deliverable through legislation.

When thinking about how I could contribute within this long list of speakers in a positive way, I decided to go back to the noble Baroness’s report and to the patients who spoke to her. If I were delivering this as a public speech, I would at this point deliver a trigger warning: what I am about to say is very disturbing. That needs to be said now.

I will quote three of the patients quoted in the noble Baroness’s report. The first is identified as a mesh-affected patient who said:

“I have had a constant battle to get the help and treatment I needed with my mesh complications. ‘Gaslighting’ and a ‘fobbing off’ culture appears to be rife”.

The second quote is from a former GP and mesh-affected patient:

“I do … believe there is a huge unconscious negative bias among you all towards middle aged females in chronic pain.”

Finally, the third quote is from Teresa Hughes, from Meshies United:

“They would tell you there is nothing wrong with you and that you are just a hysterical woman”.

It is worth reflecting briefly on the history of medicine and the medical profession. The idea of a wandering womb—with strange afflictions supposedly affecting women, particularly those of reproductive age—goes back to the ancient Greeks. We have something here that has been embedded for literally millennia. If we look to more recent history, it was the book on hysteria by Edward Jorden in 1603 that really pinned down in English something that became medical doctrine for centuries. This treatment of female patients has a very long and embedded history.

If we look back at the 1960s and 1970s, up until that point in time the culture of medicine was very much one of paternalism. The doctor, who was most often a male, knew best; the patient was told what they should do and how they should be treated. The doctor knew what was best for them and the patient had very little say or control. We can credit the women’s movement as an important part of the forces driving for change in the medical profession. We have seen change, but medical habits do not change quickly in their practices and culture. It is clear from those quotes I just read out that there is still a long way to go. There is a strong gender aspect to this, but many male and child patients were affected by it as well.

A patient safety commissioner could be someone to go to: someone who knows the system and has sufficient technical support to understand the issues, and to see where systematic breakdowns are happening and act on them. The Children’s Commissioner is a wonderful example—the noble Baroness, Lady Cumberlege, referred to it—and by chance I was referring to that commissioner approvingly in this very same Room yesterday.

We have already seen action on the recommendation for a patient safety commissioner in Scotland, and I am proud that the England and Wales sister party, the Scottish Greens, was very strong in supporting that. With this amendment, your Lordship’s House has a real chance, as we have been doing with so many Bills lately, to insert an important and key improvement.

I hope that, if not today then sometime very soon, the Government might see the sense of following the Scottish lead and the recommendations of the report of the noble Baroness, Lady Cumberlege. However, if that is not the case, I can certainly offer the Green group’s very strong support for pushing this further—as far as it needs to be pushed—to deliver this vital figure.

Baroness Thornton (Lab)

- Hansard -

Copy Link

- - Excerpts

The last remark of the noble Baroness, Lady Jolly, was very pertinent indeed.

After this debate, I probably need to say only that, from these Benches, we support the noble Baroness, Lady Cumberlege, in her proposal to establish a patient safety commissioner on a statutory basis. We have heard powerful contributions from the noble Baroness, Lady Cumberlege, herself, the noble Lord, Lord Patel, and my noble friend Lord Hunt. I always thought, when I was a Minister and since, that you should always listen when the noble and learned Lord, Lord Mackay of Clashfern, says that, in his “respectful submission”, something is a good idea; it is always a good idea for the Minister to take note of that.