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.

--- Later in debate ---

[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.

--- Later in debate ---

[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.

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

Baroness Thornton Excerpts

Wednesday 14th October 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, the pertinent question that has been asked by several noble Lords, and indeed by the noble Lord, Lord Scriven, is why this is emergency legislation. We knew this was coming. We should be grateful that we are doing this on the day it is being enacted, not three weeks later, as I have already said. But the high tier already affects 20 million of our fellow citizens, so this is extremely serious.

Areas already under additional local restrictions are automatically in the “high” alert level, which means bans on households mixing indoors are extended to include hospitality venues. Noble Lords have already asked questions on the illogicalities involved. I think the Minister realises that this is not simple or straightforward. As several noble Lords have said, the criteria on which local lockdowns are enacted remain a mystery to us. Regions with similar infection rates are being treated differently. The criteria by which an area will move from one to another, down to “medium” or up to “very high”, also remain a mystery.

The problem that causes, apart from a lot of confusion, is that there will always be a suspicion that a political choice is being made. It is another reason why a local partnership to create safety locally is so important, as those suspicions still exist. The Minister and other members of the Government have said that we should not take too much notice of what is being said in the media by local politicians when, behind the scenes, you are all working together and it is all going extremely well. Too often, it is clear that that is not the case. Those questions remain.

This is very important, as many people in high-risk areas are on tenterhooks following the announcement last night that the Government are set to hold a Gold Command meeting today to discuss whether Greater Manchester and Lancashire need to be reclassified into tier 3. The Minister said that negotiations with local leaders are key to deciding whether an area moves into a higher level of restrictions, and presumably a lower level as well, as we move forward—hopefully.

I would like to ask the Minister about the Prime Minister’s suggestion that Manchester was not placed in tier 3 because the local authorities refused. The Prime Minister said:

“I also hope that Opposition Members who are calling on me to do more in Greater Manchester will prevail on the authorities there to come into tier 3 and to help us to get there.”—[Official Report, Commons, 12/10/20; col. 32.]


Can the Minister explain to us how that works and what is happening?

As other noble Lords have said, and indeed as we said in the last debate about the “very high” statutory instrument, testing and tracing is absolutely vital. Jamie Driscoll, the North of Tyne Mayor, whose area is also in the second-highest risk tier, said the new system was

“like whack-a-mole without knowing where the moles are”,

because of failings in the test and trace system in his area. Can the Minister confirm that the contact-tracing app for England and Wales has sent only one alert about a coronavirus outbreak in a venue since it was launched two weeks ago, despite being used for millions of check-ins? This is despite the Government stating that hospitality settings such as pubs, bars and restaurants are a “significant” source of coronavirus infections, with data shared by the CMO suggesting that more than 30% of coronavirus exposure is in fact in pubs, bars, restaurants and cafés. Does the Minister accept that the absence of targeted venue alerts is undermining the core principle of this system? Will he devolve further responsibilities for test and trace to local leaders in the high tier, to help them take the action they need to avoid the economic damage of being placed in the highest tier of restrictions at a later stage?

Does the Minister share my concern that the focus on areas causing the most concern means that areas with comparatively lower infection rates risk being overlooked? The key word here is “comparatively”, because the goalposts keep moving as infection rates increase in certain parts of the country. Bristol’s case numbers, for example, are considered to be “low”, but would have been considered “horrific” two or three weeks ago. The noble Lord, Lord Scriven, was quite right: we have not had time to discuss real cases and real issues. These tiers may be the right way forward, and we certainly will not oppose these restrictions, but we have not teased out all the problems that are caused by the lack of real consultation and discussion.

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

Baroness Thornton Excerpts

Wednesday 14th October 2020 Lords Chamber

[Baroness Thornton (Lab)]

I thank the Minister for his explanation of this SI and indeed of the others. I compliment him, as other noble Lords have been doing, on—I do not know what the word is; “sturdiness” is not quite right—his resilience under fire, apart from anything else.

In many ways, this might be the most important SI before us today because it concerns the whole of the rest of the country, which is subject to restrictions that we are all very familiar with and know about. The success of combating the virus will depend in part on those restrictions being adhered to by the rest of the country, so that communities do not move into the next tier. As the Minister said, coronavirus cases are increasing at a terrifying rate.

I want to ask particularly about London. While it seemed that lockdowns were happening mostly in the north, it now seems that London might be heading towards one. Indeed the mayor, Sadiq Khan, has been pressing the Government to put in tougher restrictions in the capital for some time, such as a ban on households mixing. I echo what other noble Lords, including my noble friend Lady Andrews, have said: why are the Government hesitating?

All London’s 32 boroughs have been placed on the Government’s official watch list, which highlights that they are areas of concern, but some are more concerning than others. Eight London boroughs are above the infection rate threshold of 100 per 100,000. Ealing is 136.9; Richmond is 133.3; Redbridge is 124.5. Some of those rates are higher than those for boroughs and cities that are already included in the second tier. This is an important issue because London has very diverse communities and some very poor ones. One of London’s great strengths and, in these days of Covid, vulnerabilities, is how mixed it is and how large its BAME communities are. We have already lost too many BAME fellow citizens, particularly those who work for the NHS. London has not been spared any of that.

Compared to London, Doncaster has an infection rate of 136.9 per 100,000 and is currently in the high tier. Leicester went into lockdown on 30 June with an infection rate of 135 per 100,000. My honourable friend Jonathan Ashworth has asked why the city of Leicester is in tier 2 with restrictions, yet Charnwood—the constituency of Edward Argar MP—where the infection rate is 150 per 100,00, is not. Why are North East Derbyshire, where the rate is 164, or Barrow, where it is 277, not in that tier? There are questions about why other areas have not been included.

Sadiq Khan says that across our city

“the average over the last 7 days is about 90 per 100,000. All the indicators that I have: hospital admissions, ICU occupancy, the numbers of older people with cases, the prevalence of the disease, the positivity, are all going in the wrong direction. Which means, I’m afraid it’s inevitable over the course of the next few days London will have passed a trigger point”.

Is that correct? When was the Mayor of London invited to a COBRA meeting? Have conversations happened at a senior level with the leading citizen of our capital city, as they should have?

As my noble friend Lady Donaghy said in her pertinent questions, we are very concerned about probity. At some point, there has to be a reckoning of the governance of the contracts that the Government have given during this pandemic. My noble friend Lord Robertson underlined that point, in relation to track and trace. My noble friend Lord Rooker also raised the issue, with his usual tenacity. My noble friend Lady Andrews asked the Minister the key question which has been asked all afternoon. I am not sure that I have heard an answer yet. Why did the Government ignore the advice they were given on 21 September?

On a lighter note, the Minister referred to “the rose garden”. My noble friend Lady Donaghy asks whether he means the rose garden at the White House in Washington or the one that Dominic Cummings occupied in Downing Street?

[Lord Bethell (Con)]

I thank noble Lords for a detailed and illuminating debate which focused, quite rightly, on the interplay between the local picture and the national one. If these restrictions are about one thing, they are about trying to make focused, local lockdown work, so that we can avoid another great, clunking, national lockdown, which would come at enormous social and economic cost. We have seen some incredibly impactful local lockdowns work in Swindon—it was an intervention there, rather than a lockdown—Luton, Leicester and other cities. We are determined to try to make these work.



Getting them to work, as the noble Baroness, Lady Donaghy, rightly said, totally depends on getting the interplay between national and local government right. I am grateful to her for reminding us that the LGA has welcomed these restrictions and the spirit of partnership between local and national government.

In response to the noble Baroness, Lady Donaghy, yes, we absolutely want to work with and deploy the expertise of local authorities. We also absolutely need to back major restrictions with the money to support those communities—the charities and civic institutions, the businesses that are hard hit and the individuals whose jobs are put at risk or who need to stand down. I reiterate the sentiments of the noble Lord, Lord Dholakia, who said we will end up more united than we have ever been. I would really like to dwell on that positive sentiment.

To reassure the noble Lord, Lord Rooker, environmental health officers have been part of our thinking from the very beginning, and reminding us of that has been central to these debates. We spoke about this in some detail in the debate on the “very high” restrictions so I will not repeat myself, but we have put in a huge quantity of resources. We now have 1,000 tier 1 central tracers and 90 contract tracing partnerships, and we have doubled the number of local protection teams. In answer to the noble Baroness, Lady Jolly, local partnerships are absolutely central to our response to Covid.

In response to the noble Baronesses, Lady Thornton and Lady Andrews, the situation in London is very much on our mind. We are in daily, if not more frequent, contact with Sadiq Khan, who has made his sentiments very clear. The encouraging thing is that with these restrictions, and the other investments we have made over the last months, we very much have a shared platform of data on which we can make joint decisions informed by the latest information—information which in no way existed in February, March and April. Talk of data in those days was wishful thinking rather than practical. With these restrictions we have a structure for applying local lockdowns, and we have a much stronger spirit of partnership between national and local government.

The noble Baroness, Lady Andrews, talked about exit strategies, which is a critical question. We have local Covid plans in place in every local authority, and these plans govern the response of the local authority and create a template for the response to the epidemic. These restrictions give a new poignancy to those plans and a new importance to the exit component. Only by working collaboratively with the communities in those local areas will the kind of behavioural changes and containment strategies that can lead to exit really work.

The noble Lord, Lord Robertson, asked about Scottish interoperability. I completely share his frustration, but it is an aspect of the mobile phone app phenomenon that they tend to interfere with each other. We are working with the Irish, Welsh and Scottish DAs to bring about the kind of interoperable nirvana of which he dreams. We hope to introduce a new version shortly.

I would be very glad to write to the noble Baroness, Lady Uddin, with the protocols for those caring for the vulnerable. Those protocols exist and I would be glad to share with her a link to them.

To answer the noble Lord, Lord Rooker, youth clubs are open. There are extremely detailed guidelines for making them Covid-safe; that is the only way in which young people can mix together in those youth clubs. Again, I would be very glad to share those guidelines with him if that would be helpful.

Towards the noble Lord, Lord Bilimoria, I feel a degree of resentment. I thought that I was the country’s leading evangelist and advocate for mass testing, the power of surveillance and innovative technologies such as LAMP and lateral flows, but it seems that the noble Lord has stolen my crown, because he is absolutely the No. 1 evangelist for them. I applaud wholeheartedly his sentiments on that matter.

I am genuinely touched by the kind comments that people have made about these debates and my contributions to them. They are really important; there is a huge amount of them—nor do I think they will stop any time soon. I am glad that this debate is happening on the day that these SIs have been brought into force, which brings a new relevancy to it. I extend my thanks to my opposite numbers: to the rota of spokespeople on the Lib Dem Bench and to the noble Baroness, Lady Thornton, for her enormous stamina. She has been in lock-step with me all the way, and I am grateful to her both for her insightfulness and for the collaborative way in which she has gone about these debates. I extend my thanks also to the Whip, my noble friend Lady Penn, who has been a huge support and demonstrated massive stamina.

My noble friend Lord Eccles asked about the relevancy of these debates. They are absolutely relevant. There are instances where what has been said in this Chamber has been carried into the decision-making and discussions of policy as it has happened. On masks and face coverings, on the importance of sharing data with local authorities, on issues around shielding and communications to the vulnerable, on the role of local infection control and the directors of public health, on the entire areas of social care and mental health and on the impact of restrictions on the economy, noble Lords have expressed clear, insightful and well-informed views and wisdom, and those views have been shared in the decision-making process. It has been a demonstration of this Chamber at its very best.

Covid-19: Great Barrington Declaration

Baroness Thornton Excerpts

Tuesday 13th October 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, there is some shared interest with those who drafted the Great Barrington declaration. They quite rightly make observations about the impact of the pandemic on education, and we are providing £1 billion to support those whose education has been hit by Covid. They make observations about support for those who are shielding, and we have written a new letter to 2.2 million people who are undergoing shielding. However, the noble Lord is entirely right: this is Johnny Bananas science, and we will not support it.

[Baroness Thornton (Lab)]

My Lords, the Minister and I are in complete agreement about this. The scientific understanding of Covid-19 suggests that having had the virus does not guarantee immunity. In fact, cases of second infections are emerging around the world. Does the Minister agree that, until we have a vaccine, this proposal is both dangerous and uncertain, and begs the question of who decides who needs to lock themselves away, and for how long?

[Lord Bethell (Con)]

The noble Baroness is entirely right. Not only is the evidence of reinfection mounting—a source of huge disappointment, frankly, but something that we have to realistically face up to—but the evidence of long Covid is also mounting, with nearly one in 10 young people infected with Covid reporting some kind of ongoing illness, and many reporting extremely worrying neurological, cardiac or renal damage. This is not flu; this is not a complex cold; this is not a posh version of a duvet day. This is a very serious infection that leaves a long effect on those who are vulnerable, and even on the young and fit. We should be very wary of it.

Health Protection (Coronavirus, Restrictions) (North East of England) Regulations 2020

Baroness Thornton Excerpts

Monday 12th October 2020 Lords Chamber

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

My Lords, we are all aware of the rising rate of infection, particular after this morning’s candid briefings, and the risks that it poses. Your Lordships will therefore understand the importance of taking the necessary steps to keep members of the public safe, while continuing to keep the economy running and schools open, and heading off the need for a second national lockdown.

We know that some of the rules put in place have become increasingly complex and difficult to enforce. That is why the Prime Minister has set out—or will set out—how we will further simplify and standardise local rules by introducing a three-tiered system of local Covid alert levels in England. This is not the subject of the debate today, nor does it change the legal requirement to wear face coverings, but it should reassure noble Lords that we continue to work with the local leaders to tackle outbreaks with more targeted restrictions that are simple and constructive.

The regulations being debated today introduced the requirement that members of the public should wear a face covering in taxis and private-hire vehicles. In addition, they should be worn when inside premises that provide hospitality, such as a bar, pub or restaurant, except when eating or drinking, for which people must be seated. This means that people must wear a face covering when entering, leaving and moving around the premises.

[Baroness Thornton (Lab)]

I think the Minister will find that we are supposed to be discussing the north-east, rather than the face coverings. It does not make any difference—I am quite happy to do them that way round, but we might get confused.

[Lord Bethell (Con)]

My Lords, I apologise and give great thanks to the noble Baroness for the polite and kind way in which she brought that to my attention. At this point, we are debating statutory instruments that apply to the north-east of England and were in force on 18 September. As your Lordships may know, a Prime Ministerial Statement in the other place will address these sorts of issues and we will of course keep a careful watch on the progress of that debate.

Over the past few months, local restrictions have allowed us to home in on areas where cases are high and rising, and put targeted measures in place. I understand that the measures we are debating have greatly affected families living in Northumberland, Newcastle, North Tyneside, South Tyneside, Gateshead, County Durham and Sunderland. Families in these areas are no longer able to meet relatives as they used to. I recognise the disruption the measures cause, particularly for those relying on often complex networks of grandparents and friends to help out with childcare. We must celebrate the complex civil communions which underpin so much of our day-to-day regimes.

However, this virus is transmitted by people meeting up with each other and the horrible truth is that the closer our friendships, the more relaxed we are in each other’s company and the harder it is to keep socially distanced. These measures are not taken lightly. They are driven by our public duty to protect the most vulnerable people in our society and do our utmost to ensure that this virus does not adversely affect these groups. What is of concern is that the number of cases in the over-60s is rising; we know that coronavirus symptoms can be more severe for people in this age group. I recognise that the Government are asking many people living in these regions of the north-east to make sacrifices to protect those most vulnerable to this virus. We will need to make adjustments to our daily lives until we have suppressed or eradicated this terrible disease.

Unfortunately, as cases have gone up in these areas, we need to introduce more of these local measures. On 18 September, we introduced new restrictions on household mixing, business opening hours and table-only service in pubs, restaurants and other places serving food or alcohol right across Durham, Gateshead, Newcastle, Northumberland, North Tyneside, South Tyneside and Sunderland. Unfortunately, again, despite these measures the number of cases continues to rise sharply. Incidence rates across these parts of the north-east area are now some of the highest in the country, with Newcastle’s rate now more than 534. So, at the request of the local councils, with which we have been working closely, we will introduce legal restrictions on families mixing with other families in their homes and being able to enjoy food or alcohol only if served at a table, and with non-essential businesses being required to close at 10 pm.

These are not steps that we take lightly but we must take them, and that is what we did because we know that swift action is more likely to bring the virus under control. The quicker we can do so, the quicker we can restore the freedoms we all enjoy—in the north-east and right across this country. Targeted measures were needed to tackle the outbreaks in those areas. The council leaderships collectively agreed that a ward-level approach would not be appropriate, as widespread community transmission had been observed in all areas. People move freely through the local authorities for work and leisure; for example, 40% of people who live in County Durham work in other areas.

These regulations prevent gatherings involving more than one household in private homes or gardens. There are exemptions for those in support bubbles, for example, and on compassionate grounds. We listened to feedback from the local leaders and amended these measures so that informal childcare support bubbles are allowed. Before the national restrictions for the same purpose, we tackled the risks of community transmission by allowing table service only in hospitality venues so that people cannot move about and pass on the virus. To reduce riskier behaviours often seen later at night when people have been drinking alcohol, we imposed the restriction on entertainment and leisure venues, limiting them to opening between 10 pm and 5 am.

Noble Lords will be aware that these regulations have since been amended so that they now also prohibit families meeting up with each other in any indoor space in these areas. We revised the guidance for owners and operators of indoor settings, including places of worship, to say that they should not intentionally facilitate indoor gatherings between households. We also advised that care homes should allow visits only in exceptional circumstances to protect their vulnerable residents. No restrictions have been placed on travel, but people have been advised not to travel with people from other households.

The Secretary of State is required to review the need for the restrictions at least every 14 days. The first review was completed on 1 October, and it concluded that the restrictions must stay in place. The next review is due this coming Thursday. I thank the seven local authorities for acting collectively as well as the local resilience forum, Public Health England, the joint biosecurity centre, local council leaders and the local directors of public health. I also thank the people in the protected area in north-east of England, who have responded so well to the measures put in place. It has been a tough year for many, and these regulations have a serious but necessary impact on how they live their lives. I beg to move.

--- Later in debate ---

[Baroness Thornton (Lab)]

My Lords, after a weekend of speculation, leaks and press briefing, after the leaders of many councils—including the ones affected by these regulations—have rightly taken the Government to task about how they are conducting the local lockdowns, and after a Statement from the Prime Minister, which may be happening right now, the Minister must forgive me for feeling that we are yet again embarking on a fruitless exercise. He calls that scrutiny and assures us that we are being heard, but we on these Benches call it a continuation of the undermining of parliamentary democracy and the role of this House in particular. However, we can hope that all that might change.

Is it the case, as I heard just before I came into the Chamber, that the Nightingale hospitals are being reopened in the north-west and the north-east? If so, can the Minister explain that? If not, I would like to learn it.

My noble friends Lord Hunt and Lord Hain gave very good explanations of the issues that we face. Almost every noble Lord, possibly with the exception of the noble Baroness, Lady Morrissey, talked about the importance of localism and running things locally. The noble Baroness, Lady Barker, gave her an answer. In the face of no vaccine, how many millions of us does the noble Baroness, Lady Morrissey, suggest stay out of the way and locked up? In the face of no exit, how many millions does she want excluded from society? I am sorry that the hybrid rules do not allow her to answer those questions, but we will have another opportunity to have a go at this issue tomorrow; I look forward to that. Without any exit strategy, her proposition is not viable.

We can use this time to do what other noble Lords have done: see how things are going in the north-east. What do local leaders and others have to say? We can see certain patterns that we have seen before, with the regulations described as confusing and contradictory. As my noble friend Lord Hunt said, because of the way in which the restrictions were introduced, they have left space for dangerous conspiracy theories to fill the void. Councillor Nick Forbes, the leader of Newcastle City Council and the leader of the Local Government Association, said that the way in which the restrictions were introduced was “deeply unhelpful”. He said that, for example,

“the confusion allowed conspiracies to breed, such as the false claim that the 10 pm curfew was ‘part of a grand plan by the council to abolish alcohol’ to appease Muslims.”

Frankly, that is a very unhelpful thing to be said in a community. It was allowed to happen because the communications did not work in this case. It is deeply frustrating for local communities.

I have enormous respect for Councillor Nick Forbes, the leading councillor in this country. He called for help from the Government before the restrictions happened, but they were delayed and he says that they were confusing when they arrived. This weekend, he still came back to the Government to say how keen he was to work with them to make all this work. The Government are fortunate to have council leaders across the north-east who take that view. I hope that they respect that in the way that they conduct themselves from now on.

Noble Lords may have heard a 18 year-old Durham University student on Friday’s “Today” programme talking about having Covid, being seven hours away from home and not being properly fed. She lives in a college where she is supposed to have her meals supplied for her but was being given junk food, with no fruit or vegetables, for the week. Frankly, I thought, “Oh my God. Can’t somebody take this poor young woman some chicken soup or something?” She was also trying to complete her online lectures and so on. She said that

“it’s hard to concentrate when you’re hungry and haven’t had any vegetables in over a week.”

If I were her parents, I would be going absolutely spare with anxiety. I hope that Durham University has seen the error of its ways and is now providing nourishment for the students who have tested positive and are having to self-isolate.

I have several questions. What impact has the particular lockdown mentioned by the Minister had on mental health and well-being in the north-east? What will happen to that region next? What support will councils receive? Will test and trace be devolved to those areas? Will it be resourced?

Finally, let me say how much I welcome the third SI. I hope that support for people who need childcare is now built into the considerations on the restrictions being imposed, as we will discuss on Wednesday.

Health Protection (Coronavirus, Wearing of Face Coverings in a Relevant Place and on Public Transport) (England) (Amendment) (No. 2) Regulations 2020

Baroness Thornton Excerpts

Monday 12th October 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, the contributors to this debate have asked the Minister pretty much all the questions that need to be asked on this issue. Perhaps I may say to my noble friend Lord Campbell-Savours that I would not have minded if he had been here doing this job, because he is definitely the expert on face masks in the House.

I want to make two procedural points. First, as we move forward to discuss face masks, I cannot see any reason why we would not be discussing them before regulations are made. If there are to be any changes to the regulatory regime around face masks, I cannot see that emergency legislation needs to be used. The House is perfectly capable now of discussing whatever needs to be changed, as the science evolves, prior to enactment rather than several weeks after. Secondly, I cannot resist teasing the Minister about the fact that the Secondary Legislation Scrutiny Committee has asked the Government if they can please take care about not publishing three amended statutory instruments to correct the mistakes that they made in the first one—and they did it within 24 hours. It said:

“The Committee has noticed a recent increase in the number of correcting instruments, with several Coronavirus instruments having to be revoked or amended immediately after laying … We therefore remind all Departments to check all instruments thoroughly before laying them before Parliament”.


I think that probably counts as a B.

The noble Baroness, Lady Finlay, was correct to say that the need to wear masks was about protecting each other. The Prime Minister said last week, concerning the sharp rise in coronavirus cases across the UK, that the country had become blasé about following restrictions designed to bring the pandemic under control, but I think a lack of enforcement is partly to blame. The Prime Minister’s father, former MEP Stanley Johnson, has been pictured three times either not wearing a mask or with one tucked under his chin, in places where face coverings are required: a London shop, a Tube station and an airport.

Therefore, it is legitimate to ask the Government not specifically about Stanley Johnson’s conduct but about what assessment they have made of the levels of compliance and of people’s reasons for not following the rules. Perhaps it is because the rules are changing so quickly and are confusing, or because people are becoming blasé. As I have said, I travel in and out of London on Tubes and buses every day; as the Minister said, the wearing of masks is significantly better than it was a month ago. There is absolutely no question of that. However, there are still people refusing to wear them.

Business enforcement is an issue here. Shops and supermarkets are required by law to inform customers to wear a face covering—unless they have an exemption—which they do through signs or by telling them when they enter the premises. This is enforced by local authorities and businesses risk a fine if they fail to do so. However, there is concern that the Government may not be following through on their own advice. Four retailers—Sainsbury’s, Lidl, Morrisons and B&M, the homeware stores—were issued with warning notices by Barking and Dagenham Council in east London, after their staff were seen failing to enforce mask-wearing and social distancing by customers. After the enforcement notices were issued under anti-social behaviour legislation, stores were understood to have complained to the Department for Business, Energy and Industrial Strategy. It has been reported that a senior official at BEIS then telephoned the council and said that it

“did not have powers to enforce these guidelines using the Government’s Covid-19 emergency powers”

and that

“the action had caused a negative reaction from the operators”,

according to a letter of complaint from the council to Alok Sharma, the Business Secretary.

This is rather important. Can the Minister confirm these reports? If so, does he share my concern that maybe his colleagues are undermining these regulations, and public health? Who will enforce these regulations, and how? As the Minister said, the British Medical Association has called for face masks to be mandatory in busy outdoor areas as well as indoors, and where there is a risk of coming within two metres of other people, including in offices. It is clear that most workplaces were never designed for people to work two metres apart. The Government need to revisit the science and enforcement of wearing face masks. It would be great to have that debate before enactment.

[The Deputy Speaker (Lord Palmer of Childs Hill) (LD)]

Can we try the noble Baroness, Lady Uddin, again?

Covid-19: Local Restrictions

Baroness Thornton Excerpts

Friday 9th October 2020 Lords Chamber

[Lord Bethell (Con)]

Well, my Lords, our rule—if there is a rule—is that we are clear that our measures should be locally led. We work with local leaders first and communities to take swift action to prevent and manage outbreaks, ensuring that our responses work for them, supported by a national service which they plug into. It is for that reason that we are considering local tiers. Local alert levels or tiers are designed to standardise the interventions in place in local areas across England to make it easier to communicate what restrictions apply, and in what areas, to the public.

[Baroness Thornton (Lab)]

I follow on from the question asked by the noble Baroness, Lady Hayman. I thought the answer was remarkable, but maybe the Minister did not understand the question. In March, the Government were very keen to work with all parties and many others to get the emergency powers in place and, since then, really it has been nothing—letters to leaders informing them, diktats to local government, and accusations of undermining the national effort when legitimate questions are asked and comments are made. As we face another spike, will the Government change their habits and let stakeholders and Parliament, including your Lordships’ House, play a fuller role in designing and agreeing the national effort?

[Lord Bethell (Con)]

My Lords, I take exception to the noble Baroness’s characterisation of our approach. In fact, local planning and response are recognised as an essential part of our response to Covid, and are very much at the heart of the service. We want to have local outbreak control plans across the country. The development of local outbreak control plans is led by directors of public health; they are done on behalf of upper-tier local authorities, where the statutory responsibility for directors of public health sits, and are regularly reviewed by the local NHS, GPs, local employers, voluntary organisations and other community partners. There is also a link with local resilience forums, integrated care systems, combined local authorities and directly elected mayors as appropriate.

Health Protection (Coronavirus, Collection of Contact Details etc and Related Requirements) Regulations 2020

Baroness Thornton Excerpts

Wednesday 7th October 2020 Lords Chamber

[Baroness Thornton (Lab)]

I begin every discussion of statutory instruments these days with a preamble outlining our serious concerns about the way in which decisions have been made, announced and brought into law. Somebody said, “Groundhog Day”—I think it might have been me last time—and it sort of feels like that.

In the case of these regulations, there is no justification for their having been laid at the eleventh hour using an urgent procedure. In his introduction, the Minister used the word “housekeeping”. That is an inappropriate word for what is democratic accountability. The app has taken six months to roll out and, in that time, thought should have been given to these regulations and key stakeholders should have been consulted. Those stakeholders should have included the industries affected by them, and local government, as several noble Lords have mentioned. That can only help the Government to allow time for those who are going to have to implement the regulations to review them, which would prevent mistakes and reduce the need for amending regulations. As noble Lords will be aware, we have regulations that have had been amended and regulations that have been revoked. A bit of thinking about this could avoid wasting our time and that of the Minister and his officials. Lead-in time to prepare new regulations is vital.

The NHS Covid-19 app was finally rolled out across England and Wales on Thursday 24 September; it uses Bluetooth technology in smartphones to keep an anonymous log of people with whom an individual comes into close contact. However, as we know, it has been plagued with problems, including the fact that up to 70,000 users were blocked from logging their positive test results. Can the Minister explain how that was able to happen? There was never an issue with test results from Public Health Wales labs. I understand that that oversight has now been corrected, but I fear that confidence in this technology is being further eroded.

I am concerned that the UK’s contact tracing apps are not cross-compatible. Plenty of people regularly cross the border between England and Scotland, but the NHS Covid-19 app and Protect Scotland do not seem to work in conjunction with one another. Positive test results from one nation cannot be entered into another nation’s app—is that true?—and alerts can be received from only one app at a time. This is obviously worrying, so what steps are the Government taking to develop interoperability—a terrible word, but I could not think of another one—between the three UK apps to ensure that contacts between citizens are reliability identified? Does the Minister acknowledge that this could be important to citizens in the border regions of England and Scotland?

It is of course great that 14 million people, including me and my family, have downloaded the NHS Covid-19 app in England and Wales; that is some 24% of the UK population of 66.5 million. However, public health bodies the world over have said that Covid-19 contact tracing apps need to reach a 60% adoption level to give the population effective uptake, so it seems to me that more work needs to be done to reach the 58 million smartphone users in the UK, which is far more than 60% of the population. Why do the Government think that people have not downloaded these apps? Can the Minister confirm that one of the main barriers to the wider use of these apps is compatibility? One in five iPhones and 8% of Android smartphones currently in the use in the UK are deemed to be too old, a matter I have raised with the Minister before. Moreover, I understand that the newest models of Huawei smartphones, launched in May 2019, will not be able to run the app due to a ban on sharing technology. Is that true? Does the Minister share my concern that significant numbers of smartphone users are locked out of digital test and trace?

I now turn to the use of the QR code as a precondition of entry. I shall add to the questions that have already been asked. Has the Minister and his officials read the Big Brother Watch brief on this? It is very interesting and says that those of us on the Parliamentary Estate are not complying with the Government’s rules and the laws in these regulations, so that is a matter of some concern. I confess that I have not used a QR code on entering our canteen. I will do if that is what I am required to do, but I did not realise that I was supposed to. I would hate to think that we on the Parliamentary Estate are in breach of these laws. However, people who are older, on lower incomes or are less familiar with this technology are sometimes being humiliated because business owners do not understand the regulations or are applying them in an inappropriate way. There are a series of questions that the Minister needs to answer to make these things work.

Covid-19 Update

Baroness Thornton Excerpts

Tuesday 6th October 2020 Lords Chamber

[Baroness Thornton (Lab) [V]]

I thank the Minister for this Statement, which was made yesterday in the Commons, and for the one made on Thursday in the Commons. It seems like a good idea to take them both together, since the news about the unreported and untracked positive tests needs urgent scrutiny, and the Minister does not have to suffer double the pain of explaining the very real problems we face with the winter and the second spike.

For example, today, we see another increase in positive tests—14,522 cases reported, with two-thirds of those in the north and north-west. To summarise, we have had people being told to travel hundreds of miles for a test; hundreds of children out of school unable to get a test; tracers sitting idle, watching Netflix; care home tests taking days to be processed; the Minister’s hyperbole, saying this could be a moment of national pride, like the Olympics; and a Prime Minister in a complete muddle over the rules. The Prime Minister seems to be able to learn large chunks of Greek by heart, so why, when he does regional media, could he not at least learn which lockdown rules apply where? It is not much to ask.

The questions from my honourable friends Jonathan Ashworth and Stella Creasy in the Commons yesterday were very pertinent. The reason why they needed to ask what the contractual teams were for the contracts supplying test and trace is that they are not working well and a large amount of public money is being spent on them. Is it not sensible to ask if there is a break clause if goods being purchased with public money are faulty or not working properly, given that they have been sold to us as world-class and planet-beating? What did the Secretary of State say to these questions? Unfortunately, he reverted to the government line of blaming Public Health England. Can we see the terms and conditions and profit margins on all these contracts? Is it true that there is no break clause addressing whether these contracts do what they are supposed to? As the former chair for a few years of the procurement committee of a local CCG, at a very lowly level in the NHS, I can tell the Minister that these are vital questions which have to be asked—questions for which I would expect to be held to account.

Does the Minister agree that transparency would ensure proper governance and accountability for those charged with the stewardship and responsibility of spending public money? Let us examine this for a moment. Is it true that Public Health England’s older version of Excel has a 65,536-row limit, meaning that, in the data transfer from the big CSV file, rows were chopped off? Can the Minister confirm that the data could not be handed over to Public Health England due to the size of the Excel spreadsheet files? Why are critical databases in a national pandemic being hosted on Excel spreadsheets? Is it true that the upgrade to a later version of Excel, which copes with just over 1,000,000 rows, costs about £100? Is this an issue with one particular lighthouse lab or across all the lighthouse labs? Public Health England’s sources say that they report the data when they get it from NHS Test and Trace, so if the information is coming in incomplete, they cannot do their job.

We know that the budget for test and trace is in the region of £10 billion to £12 billion, and it seems to me that an IT audit might have been a good place to start. Was there one? What did it say? We know it is true—so, presumably, does the Secretary of State, who is ultimately responsible for Public Health England—that Public Health England’s budgets were cut by 40%. So, is it the case that Public Health England had no IT upgrades of any kind recently? Given what we know, is it legitimate to ask where all that money has gone?

Why in October, after all the promises of the Prime Minister, the Secretary of State and the noble Baroness, Lady Harding, are we now facing the possibility of 60,000 people unknowingly spreading Covid in their homes and communities, which might account for some of the sudden increases seen today? Have all those people been contacted, traced and isolated?

These are not irrelevant, disloyal or silly questions: they are vital if these matters are to be remedied. They are vital if the Government are to dispel what communities are feeling, described on Sunday by the leader of the Labour Party, Keir Starmer, as

“This deep sense of despondence, anxiety. And actually, what they want is hope.”


We on these Benches want the Government to do that: to give hope. Assuring us that they have everything under control will, however, not work anymore, because it is clearly not true.

Surely, what is needed is transparency and a strategy, expressed with clarity, that everybody understands and supports. It is, furthermore, urgent. Tonight, a group of leaders of the largest councils in the north—Manchester, Leeds, Newcastle and Liverpool—has written to the Prime Minister asking for, among other things, significant local control and support. I beg the Minister not to chant the mantra that test and trace are working closely at local level, because clearly they do not believe that it is. Again, it does not seem to be true. I hope that the Government will respond positively to these councillors.

Yesterday, Jeremy Hunt asked whether responsibility for NHS and care home staff testing should be moved to hospitals and laboratories, and that idea was repeated by the Nobel laureate Paul Nurse, of the Crick Institute, on the radio this morning. The fundamental problem is that there is no strategy: there is a vacuum. That is because there is division in the Cabinet over which strategy should be followed. This needs to be remedied and a clear way forward explained.

Finally, with regard to the part of the Statement concerning treatment: will the Minister clarify whether the establishment of Orbis will be in co-operation and collaboration with EU medicine protocols or in competition with them? Will Parliament scrutinise Orbis, and when?

[Baroness Barker (LD)]

I thank the Minister for yet again turning up at the crease to defend what is becoming increasingly indefensible: the poor performance of the NHS Track and Trace system.

The noble Baroness, Lady Thornton, was right to note the admission in this Statement that 16,000 positive results had not been uploaded, and that by yesterday only 51% of those people had been contacted, despite the injection of resources into NHS Track and Trace over the weekend to try to make up the deficit. Given that we know that each person who tests positive is likely to report between four and five contacts, that is potentially 60,000 people who last week were walking around, not self-isolating and possibly infecting others. It is not their fault—they did not know. It is a really significant breach of trust.

In the part of the Statement that I find most curious, the Secretary of State said that the Chief Medical Officer’s analysis of the Government’s assessment of the disease as a result of the new data was that

“its impact has not substantially changed.”

Can the Minister give us further detail about that? The omission of 60,000 people not having any impact does not add up at all. The Secretary of State went on to say that the Joint Biosecurity Centre had confirmed that

“it has not impacted the basis on which decisions about local action were taken last week”.—[Official Report, Commons, 5/10/20; cols. 625-6.]

When will that data come through and when will we be able to see the impact on local areas? As these statements make clear, the virus is beginning to have different impacts in different places. Can the Minister say at what point directors of public health were informed about this breach? Six months in, it is clear that, when local authorities are properly resourced and given correct and timely information, the virus is managed and contained. The major problems come about when decisions are made centrally, poorly communicated and badly executed.

Time and again, it comes back to track and trace, whether it is about a lack of skills and capacity or a lack of foresight. Who could not have foreseen the impact that hundreds of housefuls of students moving around the country in September would have on transmission?

Yesterday when this Statement was debated in another place, speaker after speaker, mostly from the Conservative Benches, got up to complain about the effect of the 10 pm arbitrary cut-off. They explained how well-run businesses, especially in the hospitality sector, will be going to the wall because of continued use of blunt instruments designed nationally and applied over wide geographical areas. How long will it be before the Government realise that local people—local professionals, directors of public health and environmental health officers—have detailed knowledge about businesses in their area, their hygiene ratings, their previous breaches of licensing conditions and where crowds congregate? When we can get decision making to a more local and granular level, we will be better able to protect good businesses without jeopardising public health.

I welcome the announcement of hospital funding for upgrades to A&E departments. We need a greater capacity for A&E. However, could the Minister give the House the definition currently used by this Government of what constitutes a new hospital?

On the Orbis project, we go into this having left a safe and highly effective system of medicines regulation, one where patient safety is paramount. How does the Government propose to withstand the commercial imperatives of American pharmaceutical companies in these circumstances?

The public are getting very worried about the extent to which the Government continue to wing it. It is time for them to bear down on the fundamental flaw in their strategy—thinking that they know best in the centre, above people who are professionals at a local level.