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: 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.

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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.

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[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.

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.

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.

Medicines and Medical Devices Bill

Baroness Thornton Excerpts

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

Moved by

[Baroness Thornton]

1: Page 1, line 6, at end insert “for a period of three years beginning with the day on which this Act is passed.”
Member’s explanatory statement
This amendment provides a sunset provision for Part 1 of the Bill requiring the Government to return with primary legislation.

[Baroness Thornton (Lab)]

My Lords, at last we begin the scrutiny of this important Bill.

Although we have been keen to make progress with the MMD Bill, if I might call it that, it is not at the expense of proper debate, and I am afraid we feel that some of the amendments before us today will not benefit from the contributions they deserve because of the clash with the Second Reading of the Internal Market Bill and the rules of the hybrid House, which seem to mean we lose the contributions of at least four, five or possibly six noble Lords who have either put their names to amendments or are keen to take part in our discussions today.

The procedure, if the House were sitting normally, is that noble Lords would “Box and Cox” between the Chamber and the Grand Committee. As it is, they are not allowed to do so and I put on record that either scheduling or rules need to ensure this does not happen again. I would be very grateful if the Minister and his colleagues ensured that the usual channels are aware of this. This clash will not deter those who are absent, I am sure, from making their contribution either later in Committee or on Report.

The group of amendments right at the beginning of this Bill concerns sunset provision, a time limit on delegated powers and draft consolidated legislation. As my honourable friend Alex Norris MP said at the beginning of the Committee session in the Commons,

“we should not just wave … off to secondary legislation without understanding what that might mean and whether there might be a better way to do it … The proposed arrangements allow the Secretary of State and his successors to make hundreds or more individual decisions to change our current regulatory regime into a markedly different one, one statutory instrument at a time, which I do not think is desirable.”—[Official Report, Commons, Medicines and Medical Devices Bill Committee, 8/6/20; col. 4.]

I agree with my honourable friend.

This is a skeleton Bill. Its aim is to provide the Government with powers to regulate on critical, life-and-death matters involving medicines, devices, humans and animals. It is at risk of inadequate scrutiny; it has an overreliance on delegated powers; it gives rise to potential regulatory divergence in Northern Ireland; it has a need for streamlined primary legislation, not statutory instruments; and it gives rise to concerns regarding patient and user safety.

It has to be said that the Delegated Powers and Regulatory Reform Committee and the Constitution Committee agreed with my honourable friend and us at Second Reading, and were particularly unimpressed by the delegated powers memorandum the department produced. It 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 using the powers. The Government has not provided the exceptional justification required for this skeleton approach. We accept that regulatory regimes in policy areas such as these require frequent adjustment, and so need to be flexible, but the Government has not made a persuasive case for conferring largely unrestricted delegated powers that can be used to rewrite the existing regulatory framework. We recognise that the existing powers to amend these complex regulatory regimes will cease to have effect on 31 December 2020 and that alternative arrangements are required. If the Government is unable to specify the principles according to which it intends to amend and supplement the existing law, the delegated powers in the Bill should be subject to sunset clauses. This would allow Parliament to scrutinise a new bill which provides sufficient detail on the policy it is being asked to approve.”


This Bill gives Ministers very broad powers indeed. We acknowledge this and are seeking full justification for them. Those are just the opening remarks from both those committees, which agreed that Clauses 1, 8 and 12 contain inappropriate delegations of power and that the Government have failed to provide sufficient justification for this part of the Bill, adopting a skeleton Bill approach, with Ministers given very wide powers indeed.

Instead of seeking to justify such powers, the Government have downplayed them by suggesting that they are like-for-like replacements for the existing powers in Section 2(2) of the 1972 Act. The delegated legislation committee found this not to be the case. The Section 2(2) power is subject to a very significant built-in constraint; it is a mechanism for transposing into UK law EU rules on medicines and medical devices that the UK is required to follow. The new powers are subject to no such constraint; they would give Ministers free rein to legislate in those areas. The Government claim that the new powers are constrained in significant ways, but the reasons found for those constraints were described as “more apparent than real”.

I suggest that over the next few weeks we need to make those constraints real, democratic and accountable, and at the same time support medicine and devices safety and supply, and promote and protect innovation and research. Given the threatening no-deal scenario which seems to be looming, it becomes even more urgent that the issues dealt with in this legislation are clear and that the routes to ensuring medicine supply, safety, research and innovation are also clear and protected, in the interests of the NHS and patients, through parliamentary accountability.

This suite of amendments aims to open that discussion. Amendment 1 in my name and that of my noble friend Lord Hunt provides a sunset clause for Part 1 of the Bill, requiring the Government to return with primary legislation. We need this to happen because it is not satisfactory or democratic to run such an important part of public policy through regulation alone. We feel that three years is a generous, sensible and reasonable amount of time. It allows for a settling in of the new regime following Brexit and time for new legislation to be framed.

Our Amendment 140 follows the advice of the two committees and ensures that there is a time limit on delegated powers.

My Amendment 116 inserts a new clause which requires the Secretary of State to publish draft consolidated legislation within two years to streamline the existing regulatory framework. It offers the Secretary of State two years of that considerable power, but asks him—it might be “her” at some point—to return in two years’ time with a comprehensive set of regulations across medicines for humans and animals, medical devices and, critically, the proposed new regime surrounding the Medicines and Healthcare products Regulatory Agency.

This would provide a chance for proper consultation across the sector, including with patient groups, industry bodies and interested companies, as well as more parliamentary scrutiny to set up the regime that we all want—a safe one, an effective one and a world-class one. It would also give us two years of life outside the European Union and would really help us to land in that place and find out how different we intend to be, certainly in this sector. I beg to move.

[Lord Patel (CB) [V]]

My Lords, as I had four minutes to speak on Second Reading, it is inevitable that it will take me longer to speak to my amendments in Committee. I refer to Amendments 50, 67 and 115 in my name, and am grateful to the noble Lord, Lord Kakkar, for his support.

Amendment 50 requires consolidated legislation for medicines, veterinary medicines and medical devices. Together with Amendments 67 and 115, it creates the same obligation in respect of veterinary medicine and medical devices and intends to complement a later amendment calling for the powers of this Bill to be time-limited to three years. The Bill confers an extensive range of delegated powers in relation to medicines, veterinary medicines and medical devices. The Government state that they intend the Bill to be the primary legislation in this area while providing no substantive content to the law.

The powers granted in this Bill go far beyond what is necessary or prudent. The existing regulatory regime for medicines is complex and unwieldy, running to more than four pieces of primary and secondary legislation implementing several EU directives in preparing for Brexit. This complexity is mirrored in respect of medical devices as the Bill merely grants powers to create future regulation through such statutory instruments. It does not provide a clear picture of the future shape of regulations that can be scrutinised. This adds to the existing regulatory complexity.

The lack of detail in the Bill in its current form could lead to uncertainty among stakeholders as to their obligations. There is a need for clarity, for regulatory bodies, manufacturers, patients and other end-users, which makes the case for more streamlined primary legislation. The lack of detail in the current Bill, the broad delegation of powers with no indication of the substantive content of future regulation created by them provides no clear or certain path ahead for medicines and medical devices that can be scrutinised or relied on by stakeholders. For this reason, this amendment, together with similar amendments for veterinary medicines and medical devices, requires that the Government return with consolidated legislation in due course.

I refer briefly to Amendment 115, which relates to medical devices. As with medicines, the regulation relating to medical devices is complex and unwieldy. Currently, it consists of the Medical Devices Regulations 2002, which implement three different EU directives and the Medical Devices (Amendment etc) (EU Exit) Regulations) 2019, which came into force at the end of the EU exit implementation period and runs to over 200 pages of detailed amendments. The 2019 regulations were intended to ensure that the existing medical devices regulations continue to operate correctly, once we had left the EU, but they also mirror and implement key aspects of EU regulation on medical devices, Regulation (EU) 2017/745 MDR.

The regulations were due to be implemented this year, but following the European Union withdrawal agreement, they will come into effect at the end of the transition period. The MDR was also due to be implemented during the transition period. Had it done so, it would have automatically become part of UK law. However, due to the disruptions of Covid-19, the implementation date of MDR was postponed by a year. The situation is complicated further by the ambiguous operation of the 2019 regulations in light of the postponement until the end of the transition period, much like the MDR. The 2019 regulations contain clauses which set specific dates and periods of transition between the implementation of different provisions and considerations.

I hope I have made the point that there is a need to have consolidated legislation. The current Bill will simply add to the existing body of regulations without consolidating or clarifying any of these issues. This demonstrates the need to time-limit these delegated powers and ensure that consolidation primary legislation is introduced to Parliament after three years, in order to subject any policy changes to adequate scrutiny.

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[Lord Bethell (Con)]

My Lords, I hear the noble Lord, Lord Patel, very clearly. The arguments that he made during our conversations and engagement earlier were powerful. The comments made by my noble friends Lord Lansley and Lord O’Shaughnessy, one of whom is my predecessor and one of whom is a former Health Secretary, were also extremely persuasive.

The Government do not think that putting consolidation in the Bill is wise, but we hear the points made by the noble Lord, Lord Patel, loud and clear. We would definitely consider this matter at a future date if the arguments made were persuasive and agreeable.

[Baroness Thornton (Lab)]

My Lords, I thank all noble Lords who took part in this preliminary and important debate on the Bill.

The noble Lord, Lord Patel, made an important point concerning primary legislation after three years. The Minister seemed to suggest that three years is not long enough. That cannot be right; three years is certainly long enough. Without the principles and policy that my noble friend Lord Hunt spoke about, rule by regulation is not only inadequate but probably quite dangerous. That lies at the heart of this group of amendments.

The noble Lord, Lord Kakkar, made the important point that we have a well-designed regulatory framework in the UK; this amendment is not about disrupting that. He also said that the Bill should be about improving the framework; that is exactly right.

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[Baroness Thornton (Lab)]

Like the noble Lord, Lord Sharkey, I shall have a minor moan. It is normal practice to give fellow Peers sight of government amendments at least on the day are put down, so even though the Bill team had not managed to discuss their intention with Opposition parties and other noble Lords involved in Committee, we received the letter from the Minister explaining the amendments on Thursday. I hope the Minister and the Bill team will not continue to leave things so late. I remind the Minister that he has a whole Bill team and a department at his disposal. Other noble Lords write their own speeches, do their own research and need more time to give amendments due consideration. I am fortunate to have some excellent support and we work very hard on our side to get our amendments down as early as possible to give other noble Lords the opportunity to consider them and discuss them with us. The Government should always bear in mind the unequal nature of resourcing in this place.

We need to see these amendments for what they are. Of course, they are mostly worthy and we welcome the improvement, but essentially, to echo the words of the noble Lord, Lord Patel, they are there to placate and circumvent. We are late in the day in beginning to understand the nature of these amendments and we now understand the urgency of them as a result of our earlier discussions, for which I thank the Minister and his team. We are waiting for reassurance from the Minister about what happens at the next stage.

The noble Lord, Lord Lansley, made some very important and pertinent points, particularly about the difference between the objective test and the subjective test. It is clever and very important. He is on the side of objectivity and the Government’s amendments are definitely on the side of subjectivity. I agree with him that Amendment 2 is not as good as his Amendment 5. The noble and learned Lord, Lord Woolf, also said something very pertinent and quite correct about not giving blank cheques. He accepts what the Government are offering, but made the point that further discussions are needed and an amendment might be needed as we move forward.

I say to the noble Lord, Lord O’Shaughnessy, that I do not have a principled objection to government amendments coming forward; it is just that we need to know the context for them. The noble Lords, Lord Lansley and Lord Kakkar, and others, including the noble Baroness, Lady Jolly, made a very important point about safeguarding public health, and I hope the Minister will be able to address it. I can probably feel an amendment coming on on that one.

[Lord Bethell (Con)]

My Lords, I am enormously grateful to my noble friend Lord Lansley and the noble and learned Lord, Lord Woolf, for Amendments 5 and 70. I greatly appreciate their scrutiny and contribution on the way in which regulations under the Bill might be made. I am grateful to my noble friend for his constructive dialogue with my officials. His experience and expertise in making legislation on health matters is a real benefit to all of us.

My noble friend and the noble and learned Lord, Lord Woolf, have drawn on the framework of legislation in the EU context. I am grateful for their explanatory statement on the basis of the amendment. My noble friend knows that I pressed very hard to see whether this is something we could accept. The challenge your Lordships have set me is why, if this framework exists in EU legislation, is it too constricting for the Bill? The answer is that examples of significant recent EU legislation in relation to human medicines, clinical trials and medical devices include: directive 2001/83/EC, regulation 726/2004, regulation 536/2014, and regulation 2017/745. In other words, while citing the aim of safeguarding public health in Article 168, on public health, of the Treaty on the Functioning of the European Union, these pieces of legislation were also made in reliance upon Article 114 of the treaty, being measures for the approximation of laws which have as their objective the establishment and functioning of the internal market. To make that point again, safeguarding public health is not the only objective of the EU legislation in relation to medicinal products and medical devices. That is why we have a challenge in this area and why we have posited our amendment.

I shall say something about the other government amendments, specifically replying to the noble Lords, Lord Hunt and Lord Sharkey, and other noble Lords who commented on them. The overall timing of the Bill means that currently, it cannot reach Report any earlier than mid-November. If we start the consent process with Northern Ireland then, it will add a minimum of two months past the end of the Bill’s timeline. To explain to the noble Lord, Lord Sharkey, we need to start the consent process now in order to make further changes. The Government need to demonstrate that this is a policy they wish to make in order for Northern Ireland to get that process properly under way. We have written to Northern Ireland seeking consent to make changes. Parts 1 and 2 of the Bill are transferred to Northern Ireland. I sought consent from Northern Ireland on the Bill as a whole when the Bill was introduced, and again after the change made on Report to Clause 16.

We sought to make government amendments at the earliest opportunity to respond to the DPRRC, partly to demonstrate how significantly we take that report and partly to start this process. That process has now started, but it has not concluded. It does not preclude noble Lords from further consideration and, as my noble friend Lord Lansley, indicated, the Bill has moved. The process of consent is unavoidably three months long in order for the Northern Ireland Assembly to conduct its work. That is why we have had to start now. In reply to the noble Lord, Lord Hunt, I can supplement the legislative consent Motion at a later date.

I will listen. I understand and acknowledge that the noble Baroness sees this as the beginning, not the end, and I acknowledge that she will return to the issue on Report. Accepting these amendments today does not prevent her doing so, and I will continue to listen.

I completely hear what the noble Lord, Lord Hunt, says about engagement with the MHRA. I would be glad to arrange a suitable engagement with June Raine from the MHRA and parliamentarians to discuss these points.

To the noble Lord, Lord Patel, I confirm that the efficacy of a medical device is assessed as part of the process of obtaining a CE certificate. The therapeutic value of a device is not part of the CE certificate assessment; that is a function carried out by NICE. On the point made by the noble Baroness, Lady Barker, on the food chain, I would be glad to arrange a follow-up discussion on the veterinary medicines directorate with the relevant Defra Minister. To the noble Baroness, Lady Jolly, Defra and BEIS are content with this amendment. To the noble Baroness, Lady Walmsley, the medical devices section of the overarching bit at the beginning of the Bill is a carry-on from the sentencing enforcement, and in Part 3 enforcement is in relation to medical devices only. I do not think these are reasons to rewrite the purpose.

I obviously hope to win the argument on some of this, but that will come from extensive engagement and thorough communication going forward, for which I thank noble Lords. I therefore hope that the noble Baroness feels able to accept these reassurances, and I am grateful that my noble friend considers this sufficient reassurance not to move his amendments.

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Moved by

[Baroness Thornton]

3: Page 1, line 6, at end insert—
“( ) In making regulations under subsection (1), the appropriate authority must have regard to the desirability of—
(a) regulatory alignment with the European Medicines Agency’s medicines regulation;
(b) regulatory alignment with EU clinical trials regulations;
(c) recognition of and participation in the European Medicines Agency’s medicines licensing processes.”
Member’s explanatory statement
This amendment requires the appropriate authority to have regard to the desirability of regulatory alignment with EU regulations.

[Baroness Thornton (Lab)]

My Lords, in many ways this group of amendments is at the heart of the Bill. The Minister will know that there is real anxiety among stakeholders, be they large or small pharma, researchers or patient groups, particularly now that we might face a no-deal exit at the end of this year. Life sciences companies have concerns about the administrative and cost implications of having to file for marketing authorisation with a separate national licensing authority after Brexit. It will be important to consult closely with the industry—industry groups, but also individual companies that have specific expertise in high tech areas—to ensure that the regulatory regime is robust, internationally competitive and fit for future scientific breakthroughs.

The amendments in my name and that of my noble friend Lord Hunt require the appropriate authority to have regard to the desirability and necessity of regulatory alignment with EU regulations. The amendments in the name of the noble Lord, Lord Patel, the noble and learned Lord, Lord Mackay of Clashfern, the noble Baroness, Lady Finlay, the noble Lord, Lord Lansley, the noble Baroness, Lady Jolly and the noble Lord, Lord Kakkar, in this group have similar objectives.

The UK via the MHRA plays a leading role in developing the clinical trials regulation, which came into force in 2014. Due to the length of the implementation period of the regulation, the UK is not currently committed to implementing it in full following the end of the transition period. Failing to implement this longstanding legislative proposal would create significant uncertainty for life science companies.

I am grateful for all the briefing we have received over the last few months from organisations and companies which have a great deal of interest at stake in the Bill. For example, Silence Therapeutics wants to make ground-breaking treatments available to patients in the UK as quickly as possible and to conduct clinical trials in the UK. In order to ensure that the UK remains a competitive and attractive destination for clinical trials, it thinks the Medicines and Medical Devices Bill should provide for continuing alignment with EU clinical trials regulations—the UK was involved in the development of that—and, in the immediate term, ensure harmonisation of clinical trial and medicines regulatory processes, while enabling international collaboration for the benefit of patients, at the end of the transition period. It also thinks the Bill should adopt an approach to clinical trials that will allow the UK to lead the world in innovation while assuring patient safety standards. These seem to me to be reasonable tests of this legislation and indicate the challenge it faces.

The danger is that the European Medicines Agency covers 25% of global pharmaceutical sales and the UK on its own makes up only 3%. The odds are that companies will want to submit applications for new drugs to the EMA before the MHRA, meaning that the UK will lose its advantage and UK patients will risk getting slower access to the latest medicines. While the Bill could help maintain patient access to new medicines and UK access to pan-European clinical trials, its capacity to achieve this will be subject to the shape of the future relationship between the UK and the EU.

On medicine access, will the Bill allow the Government to establish new regulations on marketing authorisations for new medicines? If so, how and when? Does a no-deal outcome mean an independent UK marketing authorisation process, along the lines set out in the Medicine and Healthcare products Regulatory Agency’s plans for a no-deal outcome which came out in 2018 and 2019 and which some of us lived through. Is this what might be used? Alternatively, could the UK choose unilaterally to continue to recognise a new European marketing authorisation as valid? Has that been considered? Depending on the outcome of UK-EU negotiations, what will happen if the MHRA is unable to participate and contribute its expertise in the European Medicines Agency’s marketing authorisation process?

On clinical trials, will the Government replicate the EU’s clinical trial application system, thereby reducing the administrative burden on UK-EU collaboration? This would be necessary if the MHRA had to develop a separate clinical trial application system that would operate in parallel to the EU’s. Is this the case?

Given the influence that the UK-EU future relationship will have on how the Bill’s powers can be used, will the Minister guarantee to encourage, update and consult the medical research sector as negotiations progress? Are the Government doing so already? Perhaps the Minister can give some positive reassurance by describing some of the recent discussions and negotiations. I am aware that this is in line with the ethos of Clause 40, which requires the Government to consult relevant people and organisations when proposing regulatory changes.

Treatments that utilise innovative techniques such as gene silencing are often used to treat rare diseases. These affect limited numbers of people and are often used in areas of unmet need, where no effective treatment options are available. The number of patients with a rare disease in an individual country, such as the UK, is likely to be low by definition, but for clinical trials to work—the House has discussed this many times—they require a large number of patients to take part. As a result, these trials are conducted across multiple countries.

Unified and streamlined international processes are essential to ensure that the application and authorisation processes for these clinical trials can continue to work effectively and at pace. By implementing the clinical trials regulation, the UK can remain eligible for access to the central EU portals and processes for clinical trials, which ensure that they can recruit enough patients from different countries to be successful. These processes include clinical trial submissions, reporting and authorisation requirements and, particularly importantly, inclusion in patient registries.

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[Lord Bethell (Con)]

My Lords, I will be happy to write to the noble Lord with the precise figures for phase 3 trials. However, he is right that they are incredibly important. The Bill must defend our position on phase 3 trials, which are very much the sharp end of the clinical trials process.

The learning from RECOVERY is that it is not a direct read-across to rare diseases. The noble Lord is right that in rare disease trials, we are often trying to drill down into very small communities, whereas 113,000 signed up for RECOVERY, and tens of thousands took some of the drugs that went through the trial process. However, it is the general capability of being able to run significant platforms, manage ethics at speed, get regulatory sign-off for these trials, and have a clinical trials regime which suits many different purposes. That is our objective, that is why we are putting through these reforms, and that is why we believe that the Bill can support a modernisation of our clinical trials regime.

On the European trials process, the noble Lord is entirely right that the portal contributes to speedy processes. However, it is not the only way of having a speedy sign-off of trials through Europe; we believe there are other ways of doing that.

[Baroness Thornton (Lab)]

Responding to the very last thing that the Minister said, he will have to tell us what those other ways are during the course of this discussion.

This has been a well-informed debate, as I assumed it would be. I think I was right in saying that this issue is at the heart of the Bill and how we move forward. My noble friend Lord Hunt—I thank him for his support —was quite right that this is the big issue. As the noble Lord, Lord Sharkey, said, this is the start of the discussion that we are going to have about attractiveness and where that lies and how it can express itself.

The noble Lord, Lord Lansley, put his finger on various important issues to do with clinical trials. He asked the key question, which I do not think the Minister answered. It is: if we diverge, what will that mean and how will it happen? I did not hear an answer to that question. The answer will determine what some of us do next as we move forward with this Bill. The noble Lord, Lord Kakkar, was completely correct when he said that it is vital that we get this right for the future of life sciences in the UK.

I am grateful to the noble Lord, Lord Patel, for his support for our amendments. He reminded us that we had this discussion during the passage of the main Brexit legislation, when we were told that it was not the appropriate place to such a discussion so the amendment was withdrawn. Now, at the last minute, this must be the place where we have these discussions and come to some conclusion on them.

The noble Lord, Lord O’Shaughnessy, is right. As we strike out on our own as a country, we will need new relationships and we will need to take advantage of what is on offer in the rest of the world. The transition will be very important because what happens in the meantime is vital. We will also need to ensure patient safety in this laissez-faire world, as the noble Lord explained, for example, if we decide to ignore the portal and strike out without it.

I do not doubt for a moment the Minister’s emphatic commitment to making this a success, but as we move forward, this Committee will need to understand much more than what the Minister has told us so far on the risks and opportunities. My final request to the Minister is that we will need a cross-party meeting of some depth—possibly more than one—to discuss this matter with his Bill team and the MHRA. We had such a meeting. It feels as if it was aeons ago, but I think that it was in February, perhaps March. Anyway, it was before we went into lockdown. We absolutely will need meetings and discussions before we move on to the next stage of the Bill. On that basis, I beg leave to withdraw the amendment.

Amendment 3 withdrawn.

Moved by

[Lord Hunt of Kings Heath]

4: Page 1, line 6, at end insert—
“( ) The power under subsection (1) may not be exercised to—
(a) create a criminal offence of failing to comply with a provision made in regulations; or
(b) modify penalties for existing criminal offences.”
Member’s explanatory statement
This probing amendment would remove provisions for criminal offences to be created by delegated legislation. The DPRRC considered this an inappropriate delegation of power.

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[Baroness Barker (LD)]

My Lords, I just want to add to what my noble friend Lord Sharkey said. This is a matter of principle; from the two reports by the two committees that have been cited and from the Second Reading debate, the Government can be in no doubt about the strength of feeling on it. In the light of those, the Government’s response in the government amendments in this group is, frankly, rather pathetic and not at all acceptable.

The Bill represents an enormous upheaval for one of the critical areas of our industry. The pharmaceutical industry is of immense importance to this country. Apart from anything else, to add criminal offences created through delegated powers by means of a Bill that is so spare and lacking in detail does a huge disservice to people who want to continue to pursue not just high-quality but ethical production of badly needed medicines in this country and within international frameworks. If the best the Government can do is to table the amendments in this group, they do the industry a great disservice.

[Baroness Thornton (Lab)]

I do not think that I need to say much in response to the remarks that were, I think, unanimous in their support for my amendment and the other amendments in the group. The cap on the sentence is not a good enough response by the Government. Earlier in our debates, I made a remark about amendments designed to circumvent; I am afraid that the government amendments before us are exactly that kind of amendment. They will not serve, I am afraid.

Unless the Government are prepared, as I hope they are, to table amendments that actually solve the problems and address the issues raised by the Constitution Committee and the Delegated Powers and Regulatory Reform Committee—they could not have been clearer on this issue: in this country, we do not set up criminal offences and their sentences by delegated legislation—there is nothing more for me to say, other than that I hope the Government will think again.

[Baroness Penn (Con)]

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

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

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

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

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

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

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

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

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

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

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

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[Baroness Jolly (LD) [V]]

I speak in support of these amendments in the names of my noble friend Lord Sharkey and other eminent noble Lords. I confess that I had not heard of the super-affirmative procedure until my noble friend sat me down and talked me through it, and it struck me as being eminently sensible and doable, and this is exactly the right sort of Bill—or the regulations contained herein are exactly the right sort—for the super-affirmative procedure. I ask all noble Lords to support this amendment and those who support it.

[Baroness Thornton (Lab)]

My Lords, I thank the noble Lord, Lord Sharkey, for his comprehensive introduction to this group of amendments, particularly those that he is supporting.

We are minus at least four noble Lords from this debate because of the clash with the other Bill. I have certainly made my view known to the usual channels in the next booth that we cannot continue to discuss this Bill in those circumstances because we will be missing too many people who have a stake in the Bill and amendments down. I cannot imagine what the noble Lord, Lord Forsyth, is saying to his own Benches about this—actually, I probably can, and it will not be polite, I suspect. He put his name down to this amendment and, presumably, found out that he was not allowed to speak in both the Second Reading debate and in this Committee at the same time. I can see why that rule is there, but we are finding that this really does not work.

While the affirmative procedure offers nothing like the scrutiny given to a Bill, which typically goes through several substantive stages in each House and can be amended, we agree wholeheartedly with the DPRRC’s view that Clauses 1, 8 and 12 contain inappropriate delegations of power. We are where we are, and we therefore take the view that the affirmative procedure should apply. Amendment 134 provides for all regulations to be made subject to the draft affirmative procedure rather than the negative procedure and for urgent regulations to be subject to the made affirmative procedure rather than negative procedure.

Both the DPRR Committee and the Constitution Committee have expressed considerable concern at the inappropriate use of the negative procedure in this Bill. For example, Clause 2(1)(n) provides that regulations under Clause 1 may make provision about prohibitions relating to the supply of human medicines. Clause 42(9) provides for such regulations to be subject to the negative procedure. The explanation given for this in the memorandum, which I think I referred to in the very first debate in this Committee, is as follows:

“proposals to make changes to existing provisions, or to introduce new provisions enabling the supply, administration or prescribing of medicines are made to reflect shifts in best practice following extensive consideration and scrutiny by the relevant professional bodies.”

The DPRRC found this an unconvincing explanation. I probably do as well. It noted:

“It isn’t clear why consultation with relevant professional bodies lessens the requirement for scrutiny in Parliament. Indeed, if proposed changes are sufficiently important for there to be extensive consideration and scrutiny by professional bodies, this supports requiring the higher level of scrutiny in Parliament that the affirmative procedure affords. Furthermore, the prohibitions to which clause 2(1)(n) applies are sufficiently important that breach of them is a criminal offence (punishable, in the case of 4 of the 5 prohibitions, by imprisonment for up to two years). Even accepting the appropriateness of the delegation of powers in clause 1, we take the view that the affirmative procedure should apply. The consultation requirement imposed by clause 41 of the Bill is to be welcomed but we are concerned at consultation being presented as a substitute for Parliamentary scrutiny. On the contrary, if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”


The committee also highlighted and raised concerns about Clause 9(1)(f), which provides that regulations under Clause 8 may make provision about the categories of person who may apply for veterinary medicines. The EM states:

“any proposals to make changes to existing powers or to introduce new powers for veterinary professionals to supply, administer or prescribe medicines will be subject to extensive consideration and scrutiny by professional bodies”.

Again, the committee found this unconvincing for the same reason, and took the view that the affirmative procedure still applies. I must say, I wholeheartedly agree with its assessment. As it says,

“if the exercise of the power is of sufficient importance to merit extensive consultation, it is of sufficient importance to warrant the higher level of Parliamentary scrutiny which the affirmative procedure affords.”

My amendment also addressed the egregious provisions of Clause 42 that provide that where any such regulation needs to be made urgently to protect the public from imminent risk of serious harm to health, the negative procedure applies instead. The Government’s justification for departing from the affirmative procedure was that:

“It is appropriate for regulations made in these circumstances to be subject to the negative resolution so that they can come into force immediately and provide an efficient means of addressing an imminent serious public health risk. We expect that such regulations would only need to be in place for a very short period of time, potentially shorter than it would take to schedule and hold debates”.


This is wholly inadequate.

The DPRRC stated:

“We are wholly dissatisfied by departments repeatedly arguing for powers otherwise subject to the affirmative procedure to be subject to the negative procedure where there is a need to act quickly, and seeking to justify this without acknowledging the existence of the made affirmative procedure … Even accepting the appropriateness of the delegation of powers in clauses 1 and 12, if the affirmative procedure provides the appropriate level of Parliamentary scrutiny for regulations made in reliance on clauses 6 or 15 in non-urgent cases then, in the absence of cogent reasons for the negative procedure to apply in urgent cases, we take the view that the made affirmative procedure should apply in urgent cases.”


The Constitution Committee concurred, recommending that

“the emergency powers in this Bill are subject to the made affirmative procedure, rather than the negative procedure, such that Parliament is required actively to approve them.”

The Minister will be well aware that regulations under the “made affirmative” procedure can be made and laid as expeditiously as can regulations subject to the negative procedure. They can also be laid during a parliamentary recess, unlike draft affirmative instruments. Quite frankly, it is insulting that the Government have the gall to argue for emergency powers to be subject to less scrutiny under the negative procedure, especially in the current climate when hundreds of emergency regulations have been introduced with considerable haste using the “made affirmative” procedure. Can the Minister say how this dereliction ever made it into the Bill, never mind through the Commons? I imagine that the Minister might be quite embarrassed to put her name to the Bill, which is perhaps why the Government have introduced Amendment 133 at the 11th hour.

I also speak in support of the super-affirmative amendments in the name of the Lord, Lord Sharkey. They are supported by Members across the House—including my noble friend Lady Andrews who is not here to give her support although she is extremely enthusiastic about this amendment.

Given that this is a skeleton Bill, the use of the super-affirmative procedure seems a sensible and proportionate mechanism. In this case, it would allow relevant parliamentary committees, in consultation with stakeholders, opportunities to comment on proposals for secondary legislation and to recommend amendments before orders for affirmative approval are brought forward in their final form. It has been used effectively by Governments of all colours, who recognise that it allows them flexibility when they need to bring forward regulations, while consultation and scrutiny happen before any amendments come to the House by affirmative resolution.

That is particularly important given that many areas in which we expect regulations to be laid, ranging from life sciences and clinical trials to hub and spoke pharmaceutical models, could make the contents of the SIs—and, in the absence of policy details in the Bill, even examples of draft regulation that have been published in respect of other Brexit legislation—controversial. I hope that the Minister recognises the merit of this proposal.

[Baroness Penn (Con)]

My Lords, I will begin by speaking to government Amendment 133 on behalf of my noble friend Lord Bethell. It provides significant changes that I know many will welcome. We have listened to the concerns raised about parliamentary scrutiny on emergency powers. I assure noble Lords that we have carefully considered their views and the different amendments that have been put forward on this topic.

As a result, government Amendment 133 would change applicable parliamentary procedure for reactive emergency regulations to the “made affirmative” procedure. It also provides that regulations about prescribing, advertising, packaging and labelling in relation to human and veterinary medicines will no longer be subject to the negative resolution procedure, but instead to the draft affirmative procedure. Using the “made affirmative” procedure when making regulations reactively in emergency situations affords the Government the required speed and flexibility to react to emergencies while providing that Parliament can scrutinise what has been done and why. When we make the regulations proactively, we must demonstrate the need to protect the public from the risk of serious harm; these regulations will be subject to the draft affirmative procedure.

It is important to acknowledge that the emergency powers are not intended to be used. However, as the noble Baroness, Lady Thornton, said, we are in a situation where we are currently using emergency powers, so she is correct that the “made affirmative” procedure has been put to good effect during the current pandemic. None the less, these powers are a measure of last resort to protect the public from the risk of serious harm to health.

We want to avoid using the powers reactively where possible. It is already a condition in the regulations that the situation must be accompanied by a declaration of the urgent need to protect against the imminent risk of serious harm to health. I note the questions asked by the noble Lord, Lord Patel, about the definition of that statement. I will write to him further on that matter.

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

We now come to the group beginning with Amendment 8. I remind noble Lords that anyone wishing to speak after the Minister should email the clerk during the debate. I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

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

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[Baroness Penn (Con)]

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

[Baroness Thornton (Lab)]

I have to register my objection to that. If we want a proper debate, this is not just about people making timed speeches; it is about a debate. A debate should be a coherent whole, not one or two speeches and then continuing after maybe a week’s break. Would I be allowed to make my opening speech again when we go back on the second day of Committee?

[Baroness Penn (Con)]

My Lords, we would not have a second opening speech. If the noble Baroness has strong objections, we can adjourn.

[Baroness Thornton (Lab)]

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

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

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

Health Protection (Coronavirus, Local COVID-19 Alert Level) (Very High) (England) Regulations 2020

Baroness Thornton Excerpts

Wednesday 14th October 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, my amendment says that

“that this House regrets that Her Majesty’s Government have failed to implement an effective test, trace and isolate regime for COVID-19 and calls upon Her Majesty’s Government to give all local authorities the resources they need to operate an effective contact tracing system in their areas; furthermore notes that these measures may not be sufficient to address the impact of the COVID-19 virus; and calls upon Her Majesty’s Government to provide the support local businesses and communities need to have confidence in responding to the COVID-19 pandemic.”

I speak to my amendment with a sense of real regret and sadness because, as the Minister tells us from time to time—and I believe him—he and his colleagues are working hard to deliver test and trace and fight the disease on our behalf. I recognise what a huge job the Government have. I wish to make it clear to the Minister that we will not vote against the regulations, but we will see whether we test the opinion of the House on this amendment. However, it is time to come clean. What follows is a sad account that justifies the House expressing an opinion of regret.

I hope that the Government have a plan to make test and trace, as well as investment in local communities, work. When NHS Test and Trace was launched in late May, the Prime Minister promised that it would help “move the country forward”—that we would be able to see our families, go to work and stop the economy crumbling. In the absence of a vaccine, the Prime Minister’s “world-beating” system would be worth every penny of the £10 billion-plus that the Chancellor announced in July would be spent.

This week, we learn that the Government’s SAGE scientific advisers have concluded that the current test and trace system is not working. They say that too few people are getting tested, results are coming back too slowly and not enough people are sticking to the instructions to isolate. They say that the system is having a “marginal impact” on transmission as a result and that, unless it grows as fast as the epidemic, the impact will only wane.

Tasked this spring with rolling out millions of coronavirus tests, the Health Secretary, Mr Hancock, opted for a centralised system using private firms. The business consultancy, Deloitte, was handed a contract to run testing through local drive-in and walk-in test centres, with swabs being sent for analysis at a network of national laboratories, many of which were also outsourced. Serco was also handed a deal to run contact tracing, subcontracting work to other firms as well. I am not making an argument for public versus private; it is a case of the Government not taking cognisance of the assets they already had to carry out this function.

At the same time as this was happening, local efforts were forbidden, not funded or sidelined and ignored. Local directors of public health knew much from their experience of tackling sexually transmitted diseases and food poisoning outbreaks, but their role was being limited, leaving many of them exasperated. The stakes are very high. The Imperial College study found that if test and trace worked quickly and effectively, the R number could be reduced by up to 26%.

As the system got up and running over the summer, ONS surveys of the virus’s prevalence suggested that NHS Test and Trace might be picking up only a quarter of actual cases. In July, one of the system’s senior civil servants, Alex Cooper, admitted privately that the system was identifying only 37% of the people

“we really should be finding”.

The clamour from mayors and local public health officials for a bigger role was growing. Finally, this week the Government admitted that cities and regions should be given help to do more—something that some of us have been advocating literally since February and March.

In the last week of September, the percentage of close contacts reached fell to 68.6%, the lowest level yet. Dido Harding—the noble Baroness, Lady Harding, who is the system’s head—said last month that the number of people wanting tests was three to four times the number available, while the national Lighthouse Labs in Milton Keynes, Cheshire, Glasgow and Cambridge had hit capacity. There were website warnings that no tests were available, exposing the British public on an almost daily basis this summer, especially in September when the schools went back and we saw people being sent all over the country to get tests. The scale of the task was shown when the noble Baroness told MPs that around half the available tests were actually being used by NHS patients and social care and NHS staff.

The need for testing will only increase as the virus grows and winter comes upon us. Of those transferred to the contact-tracing system in the week ending 30 September, 74% were reached. We are already a long way off the target and the system will come under greater pressure in the coming weeks. On Tuesday, the Government finally said that visitors to care homes could be tested regularly to try to end the isolation caused by their visits to loved ones being banned. There are 400,000 care home residents, so the new laboratories in Newcastle, Bracknell, Newport and Charnwood cannot come too soon.

As far back as May, SAGE experts said the speed of the results had a significant impact on the reproduction rate of the virus. The Prime Minister pledged on 3 June “to get all” non-postal

“tests turned around in 24 hours”,—[Official Report, Commons, 3/6/20; col. 839.]

but this has not been happening. The percentage of returns is too low, and the data blunder that caused nearly 16,000 tested coronavirus cases to go unreported in England last month is only exacerbated by this IT problem.

We have heard embarrassing stories about contact tracers making no calls for days on end. By contrast, local public health officials have been setting up their own call centres and deploying environmental health officers and sexual health experts with local knowledge. Being properly trained to do the job, they reckon that they are tracing up to 100% of the contacts. If they want to back a winner, it seems that that is the winner the Government really need to back.

All of this leads to the Motion I have tabled. The Government have to move quicker; that is clear and has been since March. They have to stop overpromising, share information and data more openly, trust local leaders to know their patch, and support local businesses and communities more readily when they face restrictions. The question of who gets the extra resources to be able to test, trace and isolate, and support local communities, should not depend on their alert level—that is a perverse incentive if ever I heard one. Everyone in all these communities needs to have a level of local support; then, we might see the R number reduce.

--- Later in debate ---

Moved by

[Baroness Thornton]

At end to insert “but that this House regrets that Her Majesty’s Government have failed to implement an effective test, trace and isolate regime for COVID-19 and calls upon Her Majesty’s Government to give all local authorities the resources they need to operate an effective contact tracing system in their areas; furthermore notes that these measures may not be sufficient to address the impact of the COVID-19 virus; and calls upon Her Majesty’s Government to provide the support local businesses and communities need to have confidence in responding to the COVID-19 pandemic.”

[Baroness Thornton (Lab)]

I start by congratulating our new arrival, the noble Lord, Lord Moylan. I did get confused by all the “Moy”s and so on, but I now identify the noble Lord. Frankly, that was a very disciplined maiden speech, and the noble Lord will be very popular in this House, particularly with his own Whips, if he continues to exercise such discipline in his remarks to the House.

We will not be voting against this or any statutory instrument today. We on these Benches would not actually support the noble Lord, Lord Robathan, in his amendment. I am clear to the noble Lord that I do not regard him as being the least bit wet. I thank my noble friends Lord Hain, Lady Massey, Lord Dubs and Lord Desai—my noble friend Lord Desai being my former economics tutor at the LSE many years ago. I always listen to his remarks with interest and respect.

We are grappling with a virus that spreads with speed and severity. Worldwide, in nine months, we have seen well over 1 million deaths. Here, in the United Kingdom, more than 42,000 people have died. Throughout this crisis, we on these Benches have urged the Government to adopt an approach with a strategic aim, suppressing the virus and bringing the R rate below one in order to save lives, minimise harm and keep our children safe. That has been our priority, and that is the right approach. We have supported the Government throughout on the restrictions they have brought forward. In the case of this statutory instrument, these are very heavy restrictions, but we accept that restrictions are needed. Nobody in any of the areas where the infection rates are going up is calling for no restrictions. It is in the national interest that we have a circuit break now, and we will not be voting against restrictions in the meantime.

I note that the Prime Minister chaired COBRA yesterday or the day before, and that was attended by the Liverpool City Region Metro Mayor, Steve Rotheram. COBRA confirmed the new restrictions and the ones the Prime Minister announced and were discussed in the Commons yesterday. I was encouraged that the metro mayor was at the COBRA meeting, and I wonder if the Minister could tell us how many of our mayors and leaders have been invited to COBRA, because that seems very important indeed.

That meeting followed a briefing earlier in the day from Deputy Chief Medical Officer Jonathan Van-Tam; the medical director of NHS England, Stephen Powis; and Dr Jane Eddleston, the medical lead for the north-west. They set out the latest data on the rising infection rates across the country. The latest infection rates show that the north-west has 40% of all Covid-19 cases, with an eightfold increase in patients being admitted to hospital. Currently, 30% of the north-west’s intensive care capacity is taken up with Covid-19 patients. They warned that in four weeks’ time, the north-west could see more patients in intensive care than at the peak of the first wave unless action is taken. That is one of the reasons my honourable friend Sir Keir Starmer made the statement last night about the need for a circuit-breaker. I listened carefully to what the Minister said in answer to this debate and to the issue about the nationwide local programme.

In March, I asked the Minister what would happen if I had a positive Covid test. This was right at the beginning. I asked: who would be notified? Would it be the GP? Would it be the local public health people? Would they contact my contacts? I did not get a very satisfactory answer. It emerged, within a few days, that testing regimes stopped completely in the UK, and six months later, we are crawling slowly towards an effective local testing, contact tracing and supporting system—six months later. Given that this House cannot make a meaningful intervention in these statutory instruments except by expressing an opinion—and I am glad it is the day after and the day they are coming into force, not three weeks later—after much thought, I am going to move this amendment. I think we need to regret that we do not have a satisfactory system of testing, tracing, isolating and support for our businesses and local communities. So I beg to move and to test the opinion of the House.