Blood Safety and Quality (Amendment) (EU Exit) Regulations 2020

Baroness Thornton Excerpts

Monday 2nd November 2020 Grand Committee

[Baroness Thornton (Lab)]

Like the noble Baroness, Lady Barker, and others in this Room, I have been involved in the legislation that is the subject of these regulations for, in my case, 20-odd years. I thank the Minister for his explanation of these regulations. If he looks back in the record to last year and the statutory instruments that we were discussing in Grand Committee—I think we might even be amending some of them today—he will see that his noble friend Lady Manzoor was given a particularly hard time by the Committee, because of course we were at the time putting on the statute book regulations just in case we crashed out of the European Union in March last year, and many of us resented the amount of legislative time that we wasted preparing for something which did not then happen.

It is of course important to acknowledge that these regulations are of vital and often life-saving importance, and concern literally matters of life and death.

The UK legislation for the safety and quality of blood, organs, tissue and cells, including reproductive cells, is of course based on European law. The European Union (Withdrawal) Act 2018 ensures that EU-derived domestic legislation will continue to have effect after the end of the transition period. In 2019, regulations were introduced to ensure that UK legislation in this area could function effectively after the transition period. However, Northern Ireland will remain subject to relevant EU laws as a result of the Ireland/Northern Ireland protocol. So today we are looking at four statutory instruments that would amend the 2019 regulations and enable Northern Ireland to continue to meet European law.

Like other noble Lords, I have two questions that flow from that. First, what effect will the United Kingdom Internal Market Bill have in this regard? Is it a complete waste of our time discussing these things? Secondly, as the noble Lord, Lord Lansley, and my noble friend Lord Hunt asked, what happens when there is divergence in the regulatory framework between the European Union and Great Britain?

As noble Lords have said, there is one blood establishment in Northern Ireland, and it will of course be able to continue receiving blood and blood components from Great Britain establishments. However, Northern Ireland establishments will treat Great Britain as a non-European Union member state—a third country—for this purpose. What does that mean? In practical language, will this delay or impede the use of blood products?

The provisions for importing blood or blood components from a non-EU member state are set out. The Northern Ireland blood establishment already has the required import authorisations in place, and GB blood establishments currently prepare blood and blood components to meet EU and UK standards, so Northern Ireland blood establishments can continue to receive blood or blood components from Great Britain. There are 10 hospital blood banks in Northern Ireland, which will not, I think, need to take any action as a result of this SI.

On organs for transplant, the NHS Blood and Transplant service will continue to be responsible for organ donation and retrieval in the UK. Between April 2019 and March 2020, as other noble Lords have said, 32 organs from deceased donors moved from Great Britain to Northern Ireland, and 126 organs moved from Northern Ireland to Great Britain. Organs will be able to continue moving from Great Britain to Northern Ireland. However, Northern Ireland-based establishments again will be treating Great Britain as a non-EU member state for these purposes. We are told that these are the same provisions that currently apply to organs moving within the UK, and so the changes made by the 2020 SI will make no difference. However, what of the future? What happens when and if the European Union changes the regulations in this area? How will this be impacted? For tissues and organs, as the noble Baroness, Lady Walmsley, said, time is absolutely of the essence in these matters.

The HFEA says on its website:

“As the regulator of the fertility sector we continue to support clinics during the transition period. We have been communicating regularly with clinics through our Clinic Focus publication and have developed an EU exit webpage for clinics. We believe that fertility clinics are minimising the possibility of disruption of patient treatment.”


Well, I wonder whether that is the case, actually, for fertility treatment between Ireland, Northern Ireland and Great Britain.

The Human Tissue Authority website says that

“establishments that are licensed under the Human Tissue (Quality and Safety for Human Application) Regulations 2007 (as amended) may require changes to their licence. This applies to establishments in the Human Application sector from 1 January 2021.”

So the HTA is saying that human tissue establishments will need to vary their licence in order to continue their activities post transition. This includes establishments that intend to import or export tissues and cells as the starting material for the manufacture of an advanced therapy medicinal product. That is extremely important. In what way will this take place? Will there be delays? How will it happen?

I will look briefly at sperm banks, and I asked this question last year. The UK currently imports sperm primarily from sperm banks in the USA and Denmark. How will that traffic in particular be affected by these new regulations and instruments? In the regime that we currently have, we will be a third country and no longer a member of the EEA. So I would like to have explained how that will affect the import of sperm from the sperm banks that we use in Denmark.

Medicines and Medical Devices Bill

Baroness Thornton Excerpts

Committee stage & Committee: 3rd sitting (Hansard) & Committee: 3rd sitting (Hansard): House of Lords
Wednesday 28th October 2020 Grand Committee

[Baroness Barker (LD)]

I thank my noble friend Lady Sheehan for her introduction to this amendment and the noble Lord, Lord Alton, for the detail that he added to that.

My interest in this matter stems back to 2013, when I was part of the All-Party Parliamentary Group on HIV and AIDS, which produced a report called Access Denied. It was about barriers to access to antiretroviral drugs for HIV and AIDS in low and middle-income countries. In the course of our research work for that report, we held a number of hearings with all sorts of representatives from a number of international research groups based in the United Kingdom but which worked across Africa and Asia. We met user and patient groups and also included representatives from the pharmaceutical companies.

I vividly remember sitting in a room in Portcullis House during one of our question and answer sessions and putting a question to a representative of a pharmaceutical company that has cropped up in our discussions in the last couple of days. I asked him a simple question—whether there was a direct correlation between the R&D costs of a drug and the price. With disarming candour, he said, “No”. Once people’s jaws had ceased to drop, we had the revelation that actually there is no transparency about pricing in the pharmaceutical industry or about the extent to which public and private funding goes into the development of new medicines—and, in effect, an admission that the overstatement by pharmaceutical companies of the need to charge excessive prices in some markets to maintain their viability is not substantiated.

I am not an anti-pharma campaigner. I believe that human and animal welfare rests very much on the development of pharmaceutical knowledge and science, and I am all in favour of extension of research and development of new drugs. However, for far too long Governments of all sorts have been held over a barrel by pharmaceutical companies, and that should stop.

I say this as someone who has had a long-standing interest in HIV. To see some patient groups in some parts of the world continue to become infected and, perhaps, have threats to their lives that would not occur if they had simply been born in another country is devastating. For example, in the world of HIV, very little work is being done on development of antiretroviral drugs for paediatrics because there is very little call for that in western developed nations, whereas there is a very big need for it in sub-Saharan Africa. Our involvement in these matters has a direct bearing on the lives of people across the world and on our standing not only as one of the major governmental funders through the different international funds but as a country in which research into new and emerging transmissible diseases is second to none because of our long-standing history.

For all those reasons, I very much support my noble friend Lady Sheehan, and I await with interest the answer to the question that my noble friend Lord Stunell put, which was the one I was going to ask, about proposed new paragraph (d) in my noble friend’s amendment.

[Baroness Thornton (Lab)]

The Committee owes the noble Baroness, Lady Sheehan, a debt of gratitude for bringing forward this amendment. I very much enjoyed her opening speech—and, indeed, those of the noble Lords, Lord Alton and Lord Crisp, both of whom are so well qualified to speak about international health responsibilities.

What this debate does is to remind us of how privileged we are to live in a country with free access to new medicines and innovations. However, we are now entering choppier international waters. We have been sheltered, as it were, over 40-odd years or so by the European Union’s heft and regulatory framework. So we need to take notice of the need for greater co-operation, as has been outlined by the noble Lord, Lord Patel.

I was very struck by the mention of things like price gouging by the noble Baroness, Lady Sheehan, and their dangers for those less fortunate than ourselves. On the immediate responsibilities and dangers around the Covid vaccination, which we so desperately need, the World Health Organization says that it is working on a plan to ensure equitable distribution of vaccines, but how that would be enforced in practice is not clear. Professor Mariana Mazzucato, who heads the University College London’s Institute for Innovation and Public Purpose, says:

“In a pandemic, the last thing we want is for vaccines to be exclusively accessed by countries that make them and not be universally available.”


That is absolutely right.

However, as the noble Lord, Lord Crisp, said, we need to pay attention to what is happening in the UK and what the effect of Brexit might be—and, goodness me, we are all on tenterhooks as to whether we get a deal or not. Rick Greville, the director with responsibility for supply chain at the Association of the British Pharmaceutical Industry said, in the run-up to a no-deal Brexit—the last time this happened—that there could be currency fluctuations, including a fall in the value of the pound. He said:

“You can imagine in that situation that exporting medicines into Europe would become even more profitable. It may be that”


drugs

“that currently aren’t being exported suddenly become attractive to export, driven entirely by profit”.

The UK is not invulnerable to what might happen next, and I would like the Minister’s observations on that.

Launched earlier this year, COVAX wants wealthy nations to pool funds that together can be used to develop and scale up vaccine production. In return, rich countries would have a guaranteed supply for about 10% and 15% of their population. I would also like the Minister’s answer to that, because several noble Lords have raised that question.

This is one of those debates in which one feels that so many people are better qualified to speak than oneself. I finish by quoting the noble Lord, Lord Crisp, and what he said on Monday. He said:

“This amendment is absolutely right in asserting that the UK should reaffirm its position and its rights to protect the health of its population. We should adopt it. The future will be difficult, as will the negotiations on this issue, but no one should be in any doubt about the UK’s firm position. We should support not just the UK’s position for the population of the UK directly but a global effort to deal with these important matters.”—[Official Report, 26/10/2020; col. GC 71.]


I could not have put it better myself.

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

My Lords, there can be absolutely no doubt about the importance of patient access to medicines. This is very much at the heart of the NHS constitution, and it is absolutely fundamental to how we regulate human medicines.

I completely agree with the noble Baroness, Lady Thornton, that the noble Baroness, Lady Sheehan, has done us a great service with an incredibly impressive speech, which was thoughtful and powerful and a privilege to listen to on Monday. The speeches of the noble Lords, Lord Alton and Lord Crisp, who I do not think is present, drew on many years and huge experience of international affairs and comparisons. We are very grateful for the challenge that those speeches have given us on this extremely important subject. But I reassure all speakers to this amendment that this Bill will absolutely not change the importance of patient access to medicines and how we regulate that.

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[Baroness Jolly (LD) [V]]

My Lords, the noble Baroness, Lady Cumberlege, made some telling remarks and asked some searching questions. We support the amendments in this group relating to the granting of licences and the processes of clinical trials. They aim to improve patient safety, as the granting of provisional licences will allow more information to be available on devices and medicines.

Amendment 84 is intended to probe the various thresholds for medical device trials. At present, new devices deemed to be “substantially equivalent” to something already on the market are certified as safe via a notified body and can go on to be used quite straightforwardly. In contrast to standards for introducing new pharmaceutical products, data from robust clinical trials are not required. Delays in the introduction of innovative treatments and medical devices should be avoidable. We should, and could, become a key player in the world market.

Safety is always paramount and the amendment in the name of the noble Baroness, Lady Finlay, to develop rapid, two-year, provisional MHRA licences is a good innovation. Start-ups would welcome these moves.

The noble Lord, Lord O’Shaughnessy, spoke about hip replacements. He made some helpful remarks about registries. I was a trustee of an organisation called Orthopaedic Research UK, which was left a considerable amount of money by a wealthy orthopaedic surgeon with a view to fostering innovation in orthopaedics. Research scientists, doctors and start-ups are able to bid for funding on projects to aid orthopaedic research, with a view to taking a development to market. The amendments in this group will help researchers working on these projects, as will the granting of two-year licences on these devices.

Devices certified through this process are not tested to establish whether they deliver significant patient benefit. Rather, the system only establishes that a device is not unsafe and that it fulfils its intended function. Meanwhile, even when clinical trials are required, because a device is deemed sufficiently different from what is on the market to merit that, the rules around how that research is constructed are looser than for medicines. These are practical, useful measures.

[Baroness Thornton (Lab)]

This has been a wholly positive and helpful debate, and I hope that it will lead to improving the Bill and the future of this issue. I shall speak briefly to the amendment in my name and that of the noble Baroness, Lady Watkins. It would allow the Secretary of State to make regulations about notification and reporting requirements for medical device clinical investigations, as is currently the case for medicines. It is about the equality of treatment between medicines and medical devices, so it is very straightforward.

I thank my noble friend Lord Hunt, who I suspect made a double speech, his own and that of the noble Baroness, Lady Finlay, and it is all to the good that he did. I again register the protest that we are losing experts and speakers because of the clash of timetabling.

All the amendments in this group are positive amendments about how medicines and medical devices reach the market, how the UK can build and maintain a leading position, and the regulatory framework required to support that. Amendment 97, in the names of the noble Lords, Lord Kakkar and Lord Patel, does that, and I thought that the noble Lord, Lord Kakkar, made some very interesting points about how it might best be achieved. The noble Lord, Lord O’Shaughnessy, and the noble Baroness, Lady Cumberlege, were quite right about putting patient safety at the heart of this and having higher levels of evaluation—the term used by the noble Lord, Lord Kakkar. The noble Lord, Lord Patel, got straight to the heart of the issue, which is that we need to get together to work out how best to take this issue forward at the next stage of the Bill. I look forward to what I hope will be a positive response from the Minister and then to the Government taking some action.

[Lord Bethell (Con)]

My Lords, I start by endorsing the comments of the noble Baroness, Lady Thornton, and saying that I am extremely grateful for this debate, both the spirit in which it is being conducted and the objective of trying to improve the legislation. I think it will make a big difference to the legislation.

The issue of the safety of medical devices and medicines is, of course, critical. We have been greatly moved by the report of my noble friend Lady Cumberlege, who spoke earlier to this group of amendments. It is an extensive and important report, which highlights the impact on patients when they have not been heard, when they report problems or concerns with a medicine or a medical device. It is particularly focused on pelvic mesh but could have addressed other subjects. The Government will address its detailed recommendations when the time is right.

I understand that safety is the driving concern behind Amendments 26 and 90, tabled by the noble Baroness, Lady Finlay. She offers up an alternative way in which to regulate medicines and medical devices, with the creation of a rapid, provisional two-year licence. Medicines and medical devices are regulated very differently between the two of them. That is in part because we have anticipated regulatory change for medical devices at an EU level for some years, and it is in part down to the practical realities of how they are developed.

I shall touch on the process and distinction. However, what I would say is that, intent aside, the amendments of the noble Baroness, Lady Finlay, are not necessary. Amendment 26 would introduce a rapid two-year provisional licence for medicines. The Bill as drafted already provides the necessary powers under Clauses 1 and 2(1)(d) to make changes relating to marketing authorisations. It is similarly already possible to introduce a rapid, provisional two-year licencing process as she suggests in Amendment 90 at Clause 13(1)(b) of the Bill.

By tabling parallel amendments with the same suggestion of a two-year, rapid provisional licence for medicines and medical devices, the noble Baroness suggests, perhaps, paralleling similar requirements of a pre-market assessment. The noble Lord, Lord Kakkar, suggests using the information system in the government amendment in Clause 16 in combination with a limited marketing authorisation system as a way of assessing devices before licencing them, as in his Amendment 97. We believe that Clause 13(1)(b) is sufficiently flexible to deliver the purpose of his explanatory statement. We believe that it is not needed as an amendment to Clause 16.

However, this debate is not, I think, about what the Bill could provide for; it is about what the Government will actually do. For human medicines, we have made changes in the statutory instrument that sets out the situation on 1 January. That update provides for a national “conditional marketing authorisation”, valid for one year. It can be renewed annually. It is a procedure to expedite the assessment of medicines that fulfil an unmet medical need but, importantly, maintain the robust evaluation of supporting evidence. It is less than the five years an ordinary marketing authorisation is granted for, but none the less we believe it serves the purpose. I hope the existence of that process is what the noble Baroness is driving at.

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[Baroness Jolly (LD) [V]]

My Lords, the noble Lord, Lord Patel, set the tone for this debate. I share the concerns of the noble Lord, Lord Hunt of Kings Heath; his concerns should concern us all. We are entering new territory. We have worked across an EU framework for a long time and are now going to be on our own. We need to work out policies and procedures to deal with this new landscape, which of course is what we are doing today. However, we will still have to work with Europe, if not within it.

I understand that we are to leave on 31 December, but we really must not bury our heads in the ground. Regulation will be key; mutual recognition is important. I think the Minister has referred to mutual recognition in the past. I wonder if he or the noble Baroness, Lady Penn—I am not sure who will be summing up—could clarify that issue. We need easy and ready access to new medicines, early-phase trials and the willingness of the NHS to take them up. There is also the role of NICE. We have not looked at mutual recognition of standards, but we need to share information with international partners. My noble friend Lord Clement-Jones asked a lot of pertinent questions. If the Minister does not have these issues in her brief, perhaps we might have either a letter or a meeting, because these are really meaty issues that we are discussing.

Amendment 27 would make provision to enable the Medicines and Healthcare products Regulatory Agency to work with other regulators to minimise delay so that the UK can get early access to new medicines. Amendment 45 would require the Secretary of State to publish their proposed regime for a list of fees in respect of human medicines. What is the timescale on that? It would be interesting to see this fees regime alongside the old regime that we will be leaving.

Government Amendments 48 and 66 relate to the disclosure of information in accordance with international agreements. My noble friend Lord Clement-Jones had something to say about that. Interestingly, although I am not absolutely clear, Labour’s Amendment 118 aims to protect medicines and medical devices regulations from any form of control from outside the UK in the event of a trade deal. This goes back to legislation that we dealt with, which I think we ended up renaming the international health Bill. We need to be clear, coming up to the end of the year, about what a trade deal might actually look like and what things would look like without a trade deal. Those are my reflections on the amendments.

[Baroness Thornton (Lab)]

This is a slightly strange time to be making this speech, because it seems likely that we will not hear the Minister’s speech until we reconvene in a week’s time. If that is the case, I would like to register that I will probably want to ask a question after the Minister speaks, if that is where we finally end up.

I am very grateful to the noble Lord, Lord Patel, and my noble friend Lord Hunt for the way in which they spoke at the beginning of this debate. The noble Lord, Lord Patel, went into a level of detail about the effects of the government amendments that was absolutely right and accurate. It also lies at the heart of my remarks. I need to make it clear from the outset that we on these Benches regard the government amendments to this part of the Bill as dangerous, sloppy and possibly sinister. The Minister must be aware, because we have discussed it with the Bill manager, that we regard the use of “a person” in Amendment 48 as something that should set alarm bells ringing right across the House.

I am getting a feeling of déjà vu. The Bill mentioned by the noble Baroness, Lady Jolly, started its life as the international healthcare arrangements Bill and ended it as the European Union and Swiss healthcare arrangements Bill, because it cast its net so wide. One of the giveaways is what the Government say in their description of their amendments:

“This new Clause makes clear that information held by the Secretary of State or the Department of Health in Northern Ireland in connection with human medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.”


The same explanatory statement follows the other government amendments in this group and tells us what the purpose of these amendments is. This underlines why we on these Benches will ask the Delegated Powers Committee to have another look at the Bill. These amendments fundamentally change the purpose of the Bill. It is not the same Bill that it looked at when it did its first report in July.

One of the reasons why this discussion—I am afraid I do not use the word “debate” about these proceedings—is so important is the read-across to the Trade Bill, to which I moved an amendment in Grand Committee a few weeks ago. It is about scrutiny and accountability. Amendment 45 is about fees: accountability and transparency and setting the level of fees. I would like the Minister to address that issue, which is fairly straightforward.

Amendment 118 in my name concerns international agreements. In terms of its policy content, it is probably the opposite of government Amendment 48. There is a policy clash here and I need to be clear that I am very unhappy about the fact that we have to agree to amendments that are unacceptable to us because of the time problems that the Government face on the Bill. We will be looking very carefully indeed at these sections of the Bill and will be seeking to amend them at the next stage.

The read-across we need to look at is to do with the trade negotiations with the United States, the EU and elsewhere, where we have to have systems of transparency and scrutiny about trade deals. The House of Lords passed an amendment to a previous Trade Bill on parliamentary scrutiny, but the Government have not made good their promises to give Parliament a say in new trade deals. I am concerned about the threat to our NHS and public health from these amendments, and about the misuse of information. We are concerned that, at present, Parliament does not have adequate powers to guide and scrutinise either the trade negotiations or the issues that will arise out of the Bill. We will need to look at this very carefully when it moves to the next stage.

[Baroness Penn (Con)]

My Lords, I am responding as a Whip, rather than as a Minister. I understand that this is not the ideal moment to break, but I believe that noble Lords would wish to hear a full response to the issues raised. I therefore beg to move that the debate on this amendment be adjourned.

Covid-19: Charitably Funded Hospices

Baroness Thornton Excerpts

Wednesday 28th October 2020 Lords Chamber

[Lord Bethell (Con)]

I assure the noble and learned Baroness that we understand absolutely the contribution of hospices, the value for money that they represent, the role that they play in communities and the incredible sensitivity with which they handle end-of-life and palliative care. I pay tribute to the contribution made by the noble and learned Baroness to the Living Well Dying Well charity and to Hospiscare. It is the contribution of people such as the noble and learned Baroness to the hospice care movement that has made it such a powerful and sensitive supporter of people at their time of most urgent need.

[Baroness Thornton (Lab)]

It will be quite clear to the Minister now that virtually every single Member of your Lordships’ House has a local hospice to which they are attached. Mine is St John’s Hospice in St John’s Wood, which has just launched an appeal to recoup a £1.3 million shortfall during the pandemic. Because hospices are being asked to take on more and more patients that they do not have the funding to cover, I hope that the important 4 November meeting will be based on an assessment of the need for continuing support for the sector for the remainder of 2020 and into 2021. Also, what plans do the Government have to ensure that everyone who needs quality palliative and end-of-life care will continue to receive it through and beyond the pandemic?

[Lord Bethell (Con)]

The noble Baroness will know through her work as a lay member of the NHS Camden Clinical Commissioning Group that hospices are much valued by the healthcare system. I assure her that the agenda for 4 November will include an assessment of the ongoing support that hospices will need through the winter.

Covid-19: Test Results

Baroness Thornton Excerpts

Tuesday 27th October 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, I take my hat off to the London School of Hygiene & Tropical Medicine, which runs an extremely exciting trial. In fact, the Secretary of State is visiting this very afternoon in order to get an update on that trial. Dogs can be used as a way of screening crowds in such places as airports and high-density venues. The validation of that method has not been proven yet, but I am personally extremely hopeful and remain grateful to those involved in the pilot.

[Baroness Thornton (Lab)]

We move from dogs to the technical teething problems with the app. It seems that the NHS Test and Trace app sends out exposure warnings to people stating that they have to isolate and then a few hours later sends another alert saying that there is no issue and they do not have to isolate. That probably means it is working quite well, but it does not tell anybody where they might have been exposed, or, as I have experienced, it flashes at you that you have been near someone who has tested positive and then there is complete silence. When will we be able to trust the technology to help us as well as alarm us? Secondly, when will the care homes testing speed up? Care homes’ turnaround time for tests still seems to be stuck in three to five days on average.

[Lord Bethell (Con)]

My Lords, on the app, the noble Baroness alludes to two separate issues. The first is the exposure notices, which are not sent by the NHS app but by the Apple telephone device. We have put in the new version of the NHS app a way of mitigating those exposure notices. She is entirely right that the app has no idea of your geography; that is the genius of the app and its commitment to privacy. It means that we cannot tell you where you were exposed, but also that your location and privacy are protected. On social care, we are investing in a large number of trials to try to speed up mass social care testing, including bulk testing and the use of wastewater, which we discussed earlier.

Medicines and Medical Devices Bill

Baroness Thornton Excerpts

Committee stage & Committee: 2nd sitting (Hansard) & Committee: 2nd sitting (Hansard): House of Lords
Monday 26th October 2020 Grand Committee

[Earl Howe (Con)]

My Lords, it may be for the assistance of noble Lords if I make a short statement before we recommence proceedings. As noble Lords will be aware from my noble friend Lord Bethell’s letter to Peers of 13 October, the Government have tabled a number of amendments for consideration in Grand Committee. Many of these amendments are designed to address criticisms of the Bill expressed by noble Lords at Second Reading, and in particular by your Lordships’ Delegated Powers and Regulatory Reform Committee and Constitution Committee, in an endeavour to provide reassurance to this Committee at an early moment.

Unfortunately, it has since come to light that the Government’s intention to move these amendments in Grand Committee, which we had believed was implicit in my noble friend’s letter and understood from subsequent discussions, had not in fact been clearly and properly communicated. I further understand that there was a two or three-day delay in noble Lords on the Labour Front Bench, and perhaps others, receiving the letter. I apologise to the Official Opposition, Liberal Democrat Peers, noble Lords on the Government Benches and those on the Cross Benches for the shortcomings in our communications, which, I need hardly add, we shall use our utmost endeavours not to see repeated.

There is a substantive reason why the Government wished to move their amendments in Grand Committee. It is that, according to the clear advice we have received, a legislative consent Motion by the Northern Ireland Assembly cannot be put in motion until such time as the government amendments to which I have referred become part of the Bill. Were we to delay approval of the amendments until Report, our clear advice was that this would put back the Northern Ireland legislative consent process by up to three months. Such a delay would in turn have serious consequences for the completion of this Bill, whose importance in the context of the United Kingdom’s exit from the European Union cannot be overemphasised. It is very important for the health of the public that we achieve a timely completion which does not leave us without a means of passing necessary regulations at the start of 2021.

These were the reasons why, in the short adjournment that took place during last Monday’s Grand Committee proceedings, we asked noble Lords to allow two government amendments to go through on that day. We did so particularly bearing in mind that the alternative to moving the amendments was to withdraw them, which might in turn have signalled to the Northern Ireland Executive that the amendments no longer represented government policy. We are sincerely grateful to noble Lords for their understanding and for the agreement reached on that occasion. As I have indicated, we made that request to noble Lords in good faith, driven by clear legal advice relating to the process around Northern Ireland consent Motions. Since then, some doubts have been cast on whether that advice was in all respects accurate. It is still our belief that it was, but we are seeking urgent confirmation of this, which we shall convey to noble Lords at the earliest opportunity.

More importantly, however, for this Committee, we have received unequivocal legal advice from the Public Bill Office that, notwithstanding any amendments approved in Grand Committee by unanimity, it is open to the House, and indeed to individual noble Lords, to return to the issues covered by such amendments on Report and to debate and vote on any further amendments that noble Lords wish to table. That means that by allowing government amendments to go through in Grand Committee, noble Lords would not be precluded from returning to those issues, in any way they chose, on Report. On behalf of the Government, I undertake that the Government will raise no objection to this if it is the wish of noble Lords that such further debates take place. If, notwithstanding the assurances I have given, any noble Lord wishes to object to a government amendment spoken to in Grand Committee, the Government will withdraw that amendment. In the meantime, it is the Government’s wish to enable all noble Lords to engage with Ministers and officials as fully and as regularly as they may require in an effort to achieve what we all desire for this important Bill, which is understanding and, if possible, consensus across the House.

[Baroness Thornton (Lab)]

I thank the noble Earl for that statement, which is extremely helpful. I am alarmed, or surprised, that we are at this stage looking at a grey area about whether or not it is necessary for these amendments to be moved and accepted. It is very important that that is clarified, and I would just like to make one or two other points.

Grand Committee is for probing; it is for consensus, and then it is up to the House to take the decisions on Report about that. These amendments, which we are being asked to nod through, really are not consistent with what the Companion says Grand Committee is there for, so the clarification that we will have to return to these at a later stage is, of course, absolutely necessary.

However, that also means that on Report we will have a Bill before us that is not the same Bill as we have now. It will have been significantly amended in some very significant areas of policy. So I am writing to the Constitution Committee and the Delegated Powers Committee today to ask them to look again at the Bill. When the amendments have been accepted, it will not be the same Bill as we have now.

We will not negative the amendments today, because I accept the noble Earl’s statement and, on the balance of risks, the Opposition would not wish to delay the Bill for three months, into next year. We can see the dangers that that would represent. However, I ask the Government to examine the proposal made by my noble friend Lord Hunt to the Minister and the Bill team in a meeting to discuss the issue. That was that they should look at paragraph 8.127 of the Companion and consider removing from the Bill all the government amendments concerned with this issue. We could then take those in a group at the end, on the Floor of the House. That would give us time to do the stuff we have not yet done and discuss the substance of the amendments.

If the Minister and the Bill team had come to us a month ago and said, “We’ve got this problem with the Northern Ireland consent process, and this is what it means,” we would not be having this discussion now, because we would have worked out how to resolve that problem. I regret that that is not what happened and I hope that we will now move forward in a more positive way. Finally, we will look carefully at what is added in Grand Committee as a result of these very particular circumstances and we may seek to delete or amend some of the government amendments at the next stage of the Bill.

[Baroness Jolly (LD) [V]]

With the Northern Ireland component, a time constraint was imposed on the Committee, and people have been looking at ways of solving the problem since our previous meeting. Since 8.30 am I have been in various meetings with various people looking for ways forward. The one described by the noble Earl, Lord Howe, is on the table and has been agreed by all party spokespersons. It was finally agreed at a meeting with the Minister and others at 1.30 pm. Like the noble Baroness, Lady Thornton, I am grateful to the noble Earl for his help in resolving this issue.

[Earl Howe (Con)]

I am grateful to both noble Baronesses for their responses. I think that this provides a basis on which to proceed with our Grand Committee debate today, pending further clarification on the matters that I referred to earlier between now and Wednesday, our next Grand Committee day. I can assure noble Lords that my colleagues and I will endeavour to achieve that clarity, which we will disseminate at the earliest opportunity.

[Baroness Thornton (Lab)]

I thank the noble Earl. I think that we probably need to continue this discussion, to make sure that we end up in the right place, with a Bill that we can take forward to Report.

--- Later in debate ---

Moved by

[Baroness Thornton]

8: Clause 1, page 1, line 8, leave out “have regard to” and insert “act with a view to ensuring”
Member’s explanatory statement
This amendment places a duty on the Secretary of State to act with a view to ensuring, rather than have regard to, safety, availability and UK attractiveness when exercising powers.

[Baroness Thornton (Lab)]

The amendment, in my name and that of my noble friend Lord Hunt, gives the Secretary of State a duty to act with a view to ensuring, rather than having regard to, safety, availability and UK attractiveness when exercising the powers in the Bill. The Bill states:

“the appropriate authority must have regard to … the attractiveness of the relevant part of the United Kingdom”,

and we want to change that. However, there is no definition of attractiveness in the Bill.

The Independent Medicines and Medical Devices Safety Review, led by the noble Baroness, Lady Cumberlege, published in July, focused on safety issues with just three medical interventions. Along with these, recent scandals such as those relating to metal-on-metal hips and PIP breast implants, show the need for strong regulatory oversight. Patient safety must be prioritised, including where there are competing considerations, such as the attractiveness of the UK as a place to conduct clinical trials and supply medicines and medical devices.

To address this, we believe that either the attractiveness clauses should be removed, or a statutory definition of attractiveness should be included in the Bill, along with a further provision that the appropriate authority should always prioritise safety. I beg to move.

[Lord Sharkey (LD) [V]]

I shall speak briefly to Amendments 9 and 13. I should start by saying that I enthusiastically support Amendment 8, moved by the noble Baroness, Lady Thornton. We all know that the phrase “have regard to” lacks any real force. Like her amendment, our Amendments 9 and 13 are intended to strengthen Clause 1(2), whose opening words read

“In making regulations under subsection (1), the appropriate authority must have regard to”,


followed by a list of the things to which it must have regard. Amendment 9 would change those opening words to read, “In making regulations under subsection (1), the appropriate authority must have regard to, and in the case of regulations not subject to section 42(6), (7) or (8), must publish with the draft regulations an assessment of their impact on,” and then the list of things to which regard must be had.

Clause 42(6), (7) and (8) are excluded because they contain urgency provisions and may now anyway make use of the “made affirmative” procedure. The purpose of the amendment is to ensure that there must be a full assessment of the impact of any regulation on the three specified areas. This applies to all three of the areas and is of particular importance in the assessment of safety and how it is to be prioritised, in subsection (2)(a).

Amendment 13 addresses the issue of assigning priority to the safety of human medicines, as do other amendments in this group. It would rewrite subsection (2)(a), so that instead of reading,

“the safety of human medicines”,

it would read “the priority of ensuring the safety of human medicines”. Other noble Lords have tabled amendments suggesting different ways of ensuring this priority and I look forward to hearing their contributions. But whatever the variations in approach, it is obvious that a strong, clear and unambiguous statement of the priority of the safety of human medicines needs to be inserted in the Bill.

--- Later in debate ---

[The Deputy Chairman of Committees (Baroness McIntosh of Hudnall) (Lab)]

My Lords, I will have one more go to get the noble Baroness, Lady Jolly, to join us. Lady Jolly? It is rather sad calling into the void. I take it that she is not able to join us, so I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

I thank the Minister for his reply and all noble Lords who took part in what has been a worthwhile, interesting and sometimes rather impassioned debate.

The Minister is probably being slightly optimistic in thinking that we will not attempt to implement as much of the report of the noble Baroness, Lady Cumberlege, in this legislation as we can, because we are not sure when the next Bill where we could do so will come along. He might think about that. A little while ago, we had a Bill that would have been perfect for this report’s purposes but, unfortunately, we never got any further than Second Reading.

I thank the noble Lord, Lord Sharkey, for his support as we have moved through slightly difficult times in the past few days. The noble Baroness, Lady Cumberlege, knows that she has our support for the recommendations in her amazing report. We will do everything that we can from this side of the House to make progress.

The noble Baroness, Lady Bennett, is quite right to remind us of the fact that we are dependent on animals for making sure that our medicines are safe. We should never forget that.

My noble friend Lord Hunt was quite correct when he said that patient safety needs to be central. In fact, my noble friend’s remarks reminded me of the time when I was number two to the noble Lord, Lord Darzi, when he was a Minister in the House. He was absolutely passionate about patient safety and how it could be implemented. He also made a coherent argument for the fact that you could ultimately save money if you got patient safety right from the broad GP level all the way through to the implementation of new drugs and so on.

The remarks from the noble Lord, Lord Patel, were a tour de force. They illustrated again to us, if we did not already know, that his experience and knowledge are of enormous use to the Committee.

The noble Lord, Lord O’Shaughnessy, was doing a balancing act, saying “Ooh, attractiveness, ooh, patient safety, how is that going to work out?” He started off by saying that there should not be a trade-off but I think that he might have come to the conclusion that there will be one.

Between them, the noble Lord, Lord Kakkar, and the noble Baroness, Lady Watkins, brought enormous wisdom to this discussion. Both of them were balanced in the way that they expressed the need to put patient safety at the centre of the Bill.

The Minister and my team and I need to discuss the difference between “having regard to” and “with a view to ensuring”. The two things are not the same; this is not just about semantics. We probably need to have that discussion between now and the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.

Amendment 8 withdrawn.

--- Later in debate ---

[Lord Sharkey (LD) [V]]

My Lords, I will speak to Amendment 15, but I begin by supporting Amendment 16, in the names of the noble Lord, Lord Lansley, and the noble and learned Lord, Lord Woolf. I strongly agree about the importance of the UK being seen as an attractive place to promote medical innovation.

Amendment 15 is in my name and those of my noble friend Lady Jolly and the noble Baroness, Lady Finlay of Llandaff, and I am very grateful for their support. The amendment addresses Clause 1(2)(c). As we have just discussed in the previous group, subsection (2) lists what an appropriate authority must have regard to when making regulations under subsection (1). Subsection (2)(c) specifies that the appropriate authority must have regard to,

“the attractiveness of the relevant part of the United Kingdom as a place in which to conduct clinical trials or supply human medicines”.

But we have, in extraordinary circumstances, accepted the Minister’s Amendment 14, so that the text will now read,

“the likelihood of the relevant part of the United Kingdom being seen as an attractive or favourable place in which to conduct clinical trials or supply human medicines”.

That is not a formulation that lends itself to easy measurement.

I listened very carefully to the Minister’s brief explanation of the merits of his amendment, but I was unable to see a clear and actionable distinction between his new version and the old one. It was all getting a little theological—“angels dancing on the head of a pin” sprang to mind. In any case, the new Government amendment shares two defects with the old version.

The first is that they are both completely unambitious. We should be looking at least to maintain, and preferably to increase, the attractiveness of the UK as a place to do clinical trials or supply human medicines. I spoke last Monday about the critical importance of clinical trials to the UK’s global leadership in the life sciences. I have already noted that the number and share of clinical trials has declined since 2016, and we now rank behind the US, Germany and Spain. Because of Covid, we have abandoned 1,500 trials and suspended 9,000 more. We need to do better than simply to have regard to the attractiveness or the likelihood of being seen to be attractive. We need explicitly to maintain or improve that attractiveness, as our amendment proposes.

The second defect in both the Minister’s first and second versions of subsection (2)(c) is that they fail to mention manufacturing. Why is the appropriate authority not required to have regard to maintaining or improving the attractiveness of the UK as a place to manufacture human medicines? The ABPI raised this issue in its briefing for Second Reading, saying that, in addition to having regard to the attractiveness of the relevant part of the UK to conduct clinical trials or supply human medicines, the ABPI would also value an assurance from the Government that secondary legislation will support the attractiveness of the UK as a destination to develop and manufacture human medicines.

The ABPI has a point. I raised this question, and the ABPI’s position, with the Minister in a meeting on 13 October. In that meeting, the Minister’s officials replied that they thought that manufacturing was covered in other regulations. Will the Minister confirm that and tell us which regulations explicitly require the appropriate authorities to have regard to the attractiveness of the UK as a place for developing or manufacturing human medicines? If, however, there is no such statutory requirement elsewhere, would the Minister consider adopting Amendment 15?

Amendments 58 and 78 would make the same provisions as Amendment 15 but for veterinary medicines and medical devices.

I should also say that there are obviously enough opposing or various views on the attractiveness issue to make it clear that we will want to return to this subject on Report, not only in the context of Amendment 14. I look forward to the Minister’s response to Amendment 15.

[Baroness Thornton (Lab)]

I thank all the speakers who supported our Amendment 20 and the amendments that follow on from it. I need to start by placing on the record that we do not agree with the Government’s amendments to this clause but we will not object to them. Were we not in the situation of basically having to agree to put these amendments in the Bill, this is a very good example of where we would need to have a different kind of debate. Looking specifically at the Government’s amendments, I think that adding the word “favourable” does not clarify the meaning or elucidate anything. Since we are not absolutely certain what “attractiveness” means, I am not sure we can be clear what “favourable” means either.

Our amendments, and others that noble Lords have tabled, would take the first stab at defining “attractiveness”. I am very attracted to the amendments that the noble Lord, Lord Sharkey, spoke to, because the idea of improvement is also very important. We are in the same territory and we will need to put further thought into this between now and the next stage of the Bill.

My noble friend Lord Hunt was completely correct when he spoke about the need to address how slow we are in this country in the uptake of new medicines and innovations. The noble Lord, Lord Patel, said that if we do not define “attractiveness” we might end up with the sort of undesirable trade-offs we discussed earlier today.

We have had a very interesting and useful discussion—the kind of discussion we should have in Grand Committee—where various points of view come together. We can see that we might end up with a completely new amendment at the next stage that will define “attractiveness” in the Bill and talk about the need for improvement and innovation. We will probably need to put our heads together between now and then.

[Lord Bethell (Con)]

My Lords, this has been an important discussion as to what attractiveness of the UK means. We have already moved on this issue with our amendments. We are still listening. I thank noble Lords for an instructive and wise discussion of this issue.

The noble Lord, Lord Sharkey, offers a definition in Amendment 15 that would include manufacturing. My noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, suggest adding “medical innovation”. In Amendment 20, the noble Baroness, Lady Thornton, and others set out a number of additional aspects, such as

“favourability to the establishment of research, design or manufacture of medicinal products or related services”

I reassure all those noble Lords that it is our instinct that the consideration of “attractiveness” as written in the Bill is sufficiently broad. It contains multitudes. While processes such as the clinical investigation of devices are not specifically listed as a consideration in Clause 12, they are covered in the current wording. Manufacturing is of course a vital element of the supply chain. Any impact on manufacturing will be relevant when considering the attractiveness of the UK as a place to supply medicines.

I acknowledge that the term “attractiveness”, as noble Lords have remarked in conversation, is not ordinarily found in legislation. However, I believe it is largely one of common sense. We all wish to protect the ways in which the UK is attractive. In 2015, the ABPI estimated the value of the life sciences sector to be £30.4 billion. Some 482,000 jobs were supported by the sector. We wish to protect that and to be a place for both innovators and generic manufacturers.

That is why this test is essential. It is a reminder, but it does not need to be comprehensive in the legislation. It needs simply to rule in, not rule out. That is why manufacturing is not explicitly mentioned, nor the other factors, although it is covered. Were we to list all the various aspects of how medicines and devices are made, we might miss something. We might interpret this list as prescriptive, rather than illustrative, and not cover an equally important but novel aspect of the future.

I hope that the government amendments provide further clarity. While noble Lords have drawn attention to specific aspects of how the UK is attractive, which are very important, their amendments are unnecessary. However, if there are particular considerations that the noble Lords, Lord Hunt and Lord Patel, and the noble Baroness, Lady Thornton, have concerns about—I note words such as “procurement”, “scale up”, “adoption”, “take-up of innovation” and “data-driven technologies”—I ask them to write to me. If further reassurances can be provided on why we consider this to be the right construction, I will be happy to respond.

In this instance, I hope the noble Lord, Lord Sharkey, is therefore willing not to move Amendment 15, and that other noble Lords do not feel compelled to move their amendments.

Covid-19: South Yorkshire

Baroness Thornton Excerpts

Thursday 22nd October 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, the last few days have been very unfortunate. Arrogance, spitefulness and divisiveness seem to be the characteristics of the Government’s approach to attempting to control the Covid infection these days. If I were being charitable, I might say that this is a product of panic and not actually knowing what to do next. If I were being less charitable, I would say that it is a characteristic of order by diktat, punishing and humiliating—or trying to—those who will not do as they are told when championing their communities. Thus, instead of dividing communities and bargaining with people’s jobs, there needs to be a one-nation approach to bring this country together, get control of the virus and protect the NHS. We have not seen that this week.

The Mayor of Greater Manchester said that he felt that the Government were

“playing poker with places and people’s lives through a pandemic”.

He asked what that is about. Is that the politics of the Prime Minister, Mr Cummings and the Cabinet?

To underline what we are facing, on Tuesday, the number of UK deaths rose by 241—the highest daily reported rise since the first wave of the pandemic. Noble Lords might remember the ridicule Patrick Vallance suffered when his chart suggested that an unchecked virus would lead to 200 deaths a day by mid-November; we are in mid-October and we are at 241. Similarly scary were Jonathan Van-Tam’s charts showing rising hospitalisation of the over-60s and the NHS medical director Stephen Powis saying that, on Wednesday, Liverpool hospitals will have as many Covid patients as they did at the height of the pandemic in April, and that Manchester hospitals will face the same record in two weeks’ time.

If I might be political about this, I remind the Minister that many of the new MPs from those seats on which the Government’s majority depends are learning the hard way what they signed up for: a great deal more than an oven-ready Brexit and quite the opposite of levelling up. They will have to go to their communities and justify: what the Government are doing and not doing; why children might not be properly fed over the winter months; why there will be a huge unemployment rate and businesses going to the wall; and, indeed, why the Covid infection rate is not responding to the sacrifices already being made in South Yorkshire, Manchester and other places in the north and the Midlands.

I will repeat some of the questions put in the Commons by my right honourable friend the leader of the Labour Party; perhaps I might get more coherent responses than he achieved. He asked,

“how does an area which goes into tier 3 restrictions get out of those restrictions? … If the infection rate, R, in a tier 3 area has not come below 1, will it be possible in any circumstances for that area to come out of tier 3”?—[Official Report, Commons, 21/10/20; col. 1053.]

If the criteria is not the R rate being under one, what is the criteria for moving from one tier to another? Millions of people need to know the answer to that question; millions of them are in tier 3 and millions are more likely to go into tier 3.

Last Friday, the Chief Scientific Officer said that tier 3 on its own would certainly not be enough to get the R rate below one but, on the same day, the Prime Minister said that there was only one chance of getting the infection rate down. So I repeat my right honourable friend’s question: which is it? Let us try to find some clarification on the confusion. There is still no clarity about how any local area gets out of tier 3 restrictions, nor any guarantees that communities will get the funding that they need to save jobs and businesses. I hope that they will but I am not sure that they will.

Sheffield went into tier 2 restrictions a week last Wednesday. Did Ministers make the wrong judgment a week ago or has new evidence that was not apparent then come to light, because it has now been put into tier 3? How many other areas in tier 2, such as those that neighbour South Yorkshire—including Bradford, my hometown, North East Derbyshire and Nottinghamshire —face the same fate as Sheffield? Can the Minister tell us how long South Yorkshire will be in this tier 3 lockdown? I repeat again: does the nationwide R number need to fall below one? What happens if Doncaster gets below one? Will it be able to leave lockdown?

Finally, I turn to shielding because it was suspended a few months ago, as noble Lords might recall. As we move into tier 3 and while all the science seems to suggest that the infection rate is creeping up the age groups, what will happen to shielding? Dr Stephen Griffin, associate professor in the School of Medicine at the University of Leeds, said:

“Critically, I am aghast that shielding remains paused. Whilst it saddens me to see that this is once again our only recourse to protect those most vulnerable to COVID, they must be enabled both socially and financially to protect themselves once more. Whatever transpires as a result of policy, it must be accompanied by a return to the commitments made earlier this year. Most importantly, testing”


has to work properly. His comments came after the Deputy Chief Medical Officer, Jonathan Van-Tam, expressed his concern for the rate of change in infections among the over-60s across the nation.

[Lord Scriven (LD)]

My Lords, I declare my interests as a resident of Sheffield and, knowing the area well, as a former leader of Sheffield City Council. I note that I will not be the only former leader of Sheffield City Council who will speak on this Statement; unusually, we will probably both agree with each other again.

We have to remind ourselves that going into any of these tiers, particularly very high, and a blanket lockdown is a failure of one thing: an effective test, trace and isolate system. Countries that have that do not have to have blanket lockdowns; it is absolutely vital that the Government understand that.

There is beginning to be a feeling of a north/south divide on this. It is ironic that Greater Manchester has not had any extra support for jobs when it has been in the equivalent of tier 2 for quite a few months. It is telling that, just a couple of days after London goes into tier 2, suddenly the Chancellor is on his feet talking about a tier 2 system for extra job support.

Having spoken to a number of people in South Yorkshire over the last 24 hours, let me tell you what the feeling is: anxiety, fear and uncertainty. I have spoken to people in tears, who have a business and who just do not understand why they are asked to do things. I reiterate the comments of the noble Baroness, Lady Thornton: you cannot plan a business or your life if you have no idea of the criteria and the trigger points for being released from tier 3. This cannot be left to a number of suits in an office, deciding the livelihoods and the businesses of many areas. What are the criteria and the trigger points for release and for going into a certain tier—not just tier 3? They need to be public, not the private judgments of people in a private meeting.

Also, why is the support package per head and not more nuanced? The support package for people in Sheffield is £29 per head—£30 million for business and £11 million for public health—but why is it a flat rate? When we know that older people, BAME communities and deprived people are more affected, why is there not a weighting in an area for those particular issues? They are the ones who will be greatly affected and more spending will be needed. Again, why is the business support package per capita? Why is it not based on the number and type of businesses that will be affected? Why does the formula seem so out of sync with what local areas will need to do?

I am pleased that there is support, at only £8 per head, for public health, which includes a local test, trace and isolate system. From this support, apart from money, what extra resources and expertise will local areas in South Yorkshire be able to call on to implement an effective localised test, trace and isolate system? We want to do our bit in South Yorkshire but we want to see fairness and a package that will minimise the effect of this high-level rate on both businesses and people.

Cancer Task Force

Baroness Thornton Excerpts

Tuesday 20th October 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, the situation raised by Cancer Research UK and others causes concern, but I reassure the noble Lord that we are doing more than a million routine cancer appointments and operations per week to catch up with the backlog. Urgent two-week waits for GP referrals are back to almost 85% of pre-epidemic levels and we have a massive plan to address this, which includes the creation of Covid-secure environments, switching to new drugs for those who cannot make it to hospital, the judicious use of radiography, targeted messaging to those who may suffer from the symptoms of cancer, the use of rapid health diagnostics, an alliance with charities, a cancer recovery plan and enhanced monitoring on a single version of truth basis of our progress on this important issue.

[Baroness Thornton (Lab)]

My Lords, I would like to follow up on the Question of the noble Lord, Lord Rennard, which was about investment. The UK spends on average half as much on capital in healthcare compared with similar countries, so the average number of MRI and CT scanners is well below the OECD average per million of population. Does the Minister agree that to tackle the cancer backlog and improve survival outcomes the Government must also implement the recommendations of Sir Mike Richards’s recent review into diagnostics and significantly invest in the necessary diagnostic equipment?

[Lord Bethell (Con)]

The noble Baroness is right to raise the excellent report by Professor Sir Mike Richards into cancer diagnostics. We have taken that report on board and are studying it very carefully; it will inspire us tremendously. As I mentioned earlier, £153 million has been allocated to cancer alliances. The investment in capital is an extremely important part of that. I want to flag a few immediate developments: diagnostic capability at the Harrogate and Exeter Nightingale hospitals, the community diagnostic hubs and the rapid diagnostic centres are all in focus for this investment.

Health Protection (Coronavirus, Restrictions) (No. 2) (England) (Amendment) (No. 5) Regulations 2020

Baroness Thornton Excerpts

Tuesday 20th October 2020 Lords Chamber

[Baroness Thornton (Lab)]

I thank the Minister for introducing these regulations. It is, of course, the last possible day on which we can debate them, four weeks after the policy came into force, and some of them have already been overtaken by things that have happened since. Indeed, we have already had the opportunity to debate the policy thrust of these regulations, as they are largely replaced in SI 1103, which was debated and approved by the House last week as part of the new national tier system of regulations. It rather begs the question why this debate is necessary.

I understand that this needs to proceed, because it alone sets out the level of fines for offences relating to the ministerial power to close public places. Why were those provisions not included in the three tiers regulation? I can see no reason why they were omitted, given that they remain an important part of the regulations and that the tier regulations were supposed to condense and simplify things. If there is a legitimate reason, perhaps it should have been explicitly set out in the accompanying Explanatory Memorandum. That leads me to think that this might have been an oversight and a correction. Of course, we know that corrections have been happening at quite a rate in these statutory instruments. Some 8.5% of them have been corrected or replaced; it was 12.5% in September.

Turning to the substance of the regulation, we support the measures, difficult as they are, but we have questions about the scientific evidence underpinning them, as many noble Lords have said. The Minister will be aware of the cross-party calls for the publication of the scientific evidence that informs the Government’s decision to implement these measures—specifically, whether Sage provided the Government with evidence regarding how the new curfews would impact upon virus transmission. My noble friend Lord Desai asked a very legitimate question: are the Government trying to reduce transmission of infection with the virus or deaths? It is a legitimate question to ask.

The Sage minutes published last week show that experts dismissed the idea of a 10 pm curfew for pubs, bars and restaurants as being likely to have “a marginal impact” before it was implemented across England. Last month, Professor Graham Medley, a leading member of Sage, said that the group had never discussed the 10 pm curfew, fuelling the belief that the Government adopted the measure alone, presumably based on what the Minister said about the curfew being “common sense”. Sources suggest a kind of pick-and-mix approach to “following the science”.

Last week the Health Secretary said that evidence from accident and emergency departments showed a reduction in alcohol-related admissions late at night after the 10 pm curfew, which he believed was evidence that there is less mixing and less drinking late at night. We have seen the pictures of people leaving pubs and venues and massing on the streets after 10 pm. The Health Secretary also attempted to defend those photographs by saying that that was largely outside, which seemed to miss the point—presumably because he has a ministerial car—that actually most of those people will have been using buses, tubes and other methods of getting themselves home, where maybe no form of social distancing was possible. The Government need to look again at these issues, perhaps at what is happening in Wales, where there is a drinking-up time, licensing sales are banned after 10 pm and there is no hard stop at 10 pm so things are staggered.

I want to address the concerns raised by the noble Baroness, Lady Jolly, in her amendment. It is deeply concerning—although, frankly, not surprising—that the Government have failed to consult local authorities and law enforcement agencies to ensure that the provisions are effective and enforceable. The Government’s disregard for local authorities has become a theme in the handling of this pandemic, and I resent on their behalf the repeated assurances from Ministers that somehow the leaders of local authorities who speak to the media are not being truthful about how the discussions are actually going with the Government, and that behind closed doors everything is wonderful. I think that is probably not true.

I return to the issue that we have been raising since literally the beginning of this pandemic: the responsibility for contact tracing must be given to local public health teams, along with increased support and resources, particularly for those areas that are Covid-19 hotspots.

Covid-19

Baroness Thornton Excerpts

Tuesday 20th October 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, first, I declare my interests in the register.

I thank the Minister for taking both these Statements, because we are in fact updating ourselves on Thursday’s and Monday’s Statements. Without doubt, the virus continues to grow. The R rate is now between 1.3 and 1.5, unless it has increased in the past 24 hours. We on these Benches welcome the advances in saliva and LAMP testing, of course. Indeed, I join everyone in being in awe of the work being carried out in our universities.

I will briefly describe the real-life experience of Test and Trace that happened to a neighbour of mine and her family in the past few weeks. After the first member of the family tested positive, they were given one ID and told to isolate for 14 days as a contact of that family member. The remaining members of the family tested positive four days later. They were given a second ID as a positive contact and told to isolate for 10 days. They all then gave each other’s names to Test and Trace as contacts—of course they did; they live in the same house—and were given a third ID. They were then rung up and told to isolate for another 14 days. When they put their test results into the app, they were given a fourth length of time to isolate, which did not match up with what they had been told on the phone. The various Test and Trace staff did not seem able to collate the information that they were being given or to join it up—although some of them tried, it must be said.

It is not surprising, then, that a significant number of people are not complying with self-isolation advice. They may not even understand it. This family, all of whom were being contacted several times a day by phone and text, felt that they were caught in a Kafkaesque world where they were given different advice daily. One said that when the Test and Trace adviser rang her to say that she could go out on Saturday morning, she was afraid to leave the house until the day after because that was what the app told her.

Everyone in that household wanted to get this right; indeed, they tried very hard to do so. What is being done better to make sure that people are being given clearer advice and to ensure that the Test and Trace system is keeping up with people’s changing circumstances? What efforts are being made to match up what the app tells people and what they are being told to do over the phone?

While all these resources are being expended on one family, we know that others are finding it difficult to get tests at all. The Government promised millions of tests a day. Now, 300,000 are happening per day, with the Secretary of State telling us that there will be 500,000 tests a day by the end of the month. Despite the hard work of Test and Trace workers on the ground, we know that the system is in chaos. People are not getting test results within 24 hours, and many people are still having to drive miles to a drive-in centre to get a test. If they send away for a test, it can take up to a week between ordering the test and getting a result back, especially if the test is delivered at the weekend. People are also being urged to take a test only if they have symptoms, yet we already know that up to 80% of people who have the virus have no symptoms. Once people test positive, they are being given contradictory advice about isolation times.

This virus spreads with speed, so testing must be quick, yet results are not being turned around within 24 hours. Again, when will that happen? Contacts must be traced quickly and those who are traced must be given support to isolate. Yet, to be frank, we have a badly designed system that is failing to trace sufficient contacts, has cost £12 billion so far and is paying consultants £7,000 a day. The Chancellor of the Duchy of Lancaster and Minister for the Cabinet Office, the right honourable Michael Gove, justified these failings on “The Andrew Marr Show” by saying that, when the virus is escalating,

“any test and trace system of whatever kind has less utility.”

I wonder what on earth that means. Perhaps the Minister can explain it to me.

Do the Government have confidence in the leadership of Test and Trace, now that we know that so much money is being spent on it? The Minister’s honourable friend Sir Bernard Jenkin MP said yesterday:

“May I also emphasise that one of the reasons why public confidence in the Government’s strategy is somewhat in decline is that we have yet to see the transformation of the leadership of test and trace, which I have discussed with the Secretary of State many times?”.—[Official Report, 19/10/20; col. 784.]


The Secretary of State did not seem to have any answer to his honourable friend’s question. Perhaps the noble Lord could have another go.

What is the estimate of the number of Covid-19 tests that will be delivered per day by the end of the year? As winter is coming, healthcare workers will also need constant testing. Can the Minister guarantee that all healthcare workers and care workers will be able to have quick Covid tests this winter? The Secretary of State has said that quick tests are now being bought. When will they be ready and rolled out?

I understand that a Statement is being made right now in the Commons about the situation in Manchester and the lack of support for low-paid workers and the self-employed if they move to tier 3. If a person works full time for a minimum wage, their take-home pay will be based on £8.20 an hour. If that is reduced to two-thirds, it is £5.47 an hour. Does the noble Lord think that that is a reasonable amount of money for a family with children? Why do he and his colleagues feel that it is acceptable to ask their fellow citizens to live on such a small amount? Why are we not continuing the furlough scheme?

If the mayor, Andy Burnham, and the leaders of all the boroughs in the Manchester area seem to be angry, it is because they know and understand the hardship which the noble Lord’s Government are visiting upon their communities—people who are already living on low wages—and the effect that this will have on them and their children.

[Baroness Jolly (LD) [V]]

Next week is half term. If one looks at the graphs, the south-west looks to be a good destination for the week. I live in Cornwall and tourism is vital to our economy, which was already blighted in the earlier holiday seasons this year. We need visitors and we are ready. What guidance would the Minister give those visitors about the need for social distancing and the wearing of masks? In the summer, there was a reluctance in some cases to comply; many just said that they were on holiday.

Covid-19: Information Sharing with Police Forces

Baroness Thornton Excerpts

Tuesday 20th October 2020 Lords Chamber

[Lord Bethell (Con)]

I am grateful to the noble Baroness for her insight, but I reassure her that the information on the app is not covered by this memorandum of understanding. That is a principle that has been made very clear by the NHS app. This is the data held on CTAS, the Public Health England database, and it remains the property of Public Health England; the MoU is very specific about that. As the noble Baroness is aware, the app is a distributed source of information; it has extremely high privacy barriers, and this MoU does not in any way breach those barriers.

[Baroness Thornton (Lab)]

It is disingenuous for the Minister to say, in answer to my noble friend Lord Hunt, that this is not a health issue. Following on from the question of the noble Baroness, Lady Lane-Fox, I imagine the police will have been concerned about the implications for data protection for both themselves and individuals. Therefore, I ask the Minister how personal data that is being handed over to the police is going to be stored. Who will keep it and how will it be handled? Are any discussions on data-sharing taking place or planned involving the Department of Health and Social Care, and the Home Office or Cabinet Office?

[Lord Bethell (Con)]

My Lords, the data collected by PHE for the test and trace service is held, as I said, by the Contract Tracing and Advisory Service database—the CTAS database—and it will be provided to the police on request. It is not a question of a wholesale sharing of all data. The data that can be shared with the police are the recorded name and contact details of an individual who has been instructed to self-isolate, the date on which they were told to self-isolate and the date on which the period of self-isolation ends. No testing data or health data are shared with the police at all.