Department of Health and Social Care: Unpaid Advisers

Lord Bethell Excerpts

Tuesday 17th November 2020 Lords Chamber

[Baroness Thornton]

To ask Her Majesty’s Government what recruitment policy is used by the Department of Health and Social Care in the appointment of unpaid advisers to Ministers; and whether each such appointee is required to sign a confidentiality agreement.

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

My Lords, I welcome the challenge. Perhaps I may reassure the noble Baroness that all ministerial appointments were required to declare conflicts of interest and abide by well-established codes of practice, and that all procurement went through proper departmental governance. Perhaps I may also be clear that those who stepped forward to help this country at its time of need should be praised. We should all recognise the considerable contribution of those who brought skills, energy and networks when we needed them.

[Baroness Thornton (Lab)]

My Lords, I do not see this Question as a challenge at all. It would appear that George Pascoe-Watson, the chair of the lobbying company, Portland Communications, was until recently an adviser to the Minister and used the words,

“the decision makers have told me personally”,

with regard to the Government’s intended Covid restrictions, in an email to his clients before the proposed restrictions have been publicly announced. In some places, this kind of thing could be regarded as insider trading—profiting from private information for one’s own or a company’s gain. Does the Minister believe that the rules of confidentiality have been broken? Will he be pursuing the matter? It clearly should be investigated. What form will the investigation take? Will it be departmental, or is it a matter for the Cabinet Office or the head of the Civil Service?

[Lord Bethell (Con)]

My Lords, I am extremely grateful to the noble Baroness for giving me the opportunity to set the record straight. It is worth sharing with the House that the emails to which she referred were sent after George Pascoe-Watson left his role as an adviser to the department. With the greatest respect to Portland and its chairman, the emails contained nothing more than the kind of speculation that one might find in any national newspaper. Therefore, at this stage, I thank those who have served as advisers to me and the department.

[Lord Rooker (Lab) [V]]

My Lords, given the disclosures in the Sunday Times about the Minister’s three telephone calls with suppliers and lobbyists at the same time, I am surprised that he has not recused himself. Has he complained about the newspaper placing him—the Minister —at the centre of the web of the Covid chumocracy? Does he agree with the chair of the Committee on Standards in Public Life, the noble Lord, Lord Evans, that too many in public life are disregarding the norms, ethics and propriety that have led to Portland Communications being secretly involved in government and then going off to make money?

[Lord Bethell (Con)]

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

[Baroness Jolly (LD) [V]]

My Lords, we all wish to live in a time of transparent government. On 6 April, I understand that a Minister in the department had a phone call with a former Conservative Party chairman and an adviser who had not been publicly declared, as well with as a businessman who had donated a significant five-figure sum to the party and who was later awarded PPE contracts of more than £150 million. Does the Minister know if the contract was open to tender? Given the donation and the nature of future PPE contracts, why was that not considered to be an inappropriate call?

[Lord Bethell (Con)]

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

[Lord Robathan (Con)]

My Lords, this is a huge crisis in unprecedented times. My noble friend the Minister has already thanked those who are trying to help the country at a very difficult time. Does he find it regrettable, as I do, that some are sniping at those who, for good reasons of public service, are giving their time, energy and expertise pro bono in service to this country and everyone in this Chamber?

[Lord Bethell (Con)]

My Lords, scrutiny of appointments, a commitment to transparency and declaration of interests are absolute values that we should all subscribe to. However, sneering at those who step forward to help, denigrating the intentions of volunteers who try to play their role and smearing the good name of people who have done the right thing does not have any role in this House.

[Lord Snape (Lab)]

My Lords, many years ago, the then political editor of the Sun, Mr Chris Potter, told me that the main qualification for his role was the ability to translate the musings of Ministers at the Dispatch Box for the benefit of his readers without using any words longer than “wheelbarrow”. Now that one of his successors, Mr George Pascoe-Watson, attends confidential departmental meetings, can the Minister tell the House whether the criteria for such a role has been enhanced or dumbed down these days?

[Lord Bethell (Con)]

I thank the noble Lord for his description of the role. I do not endorse it but am entertained by it. Let me be clear: the people who stepped forward and took ministerial appointments brought a wide range of skills, some of them quite soft in terms of networking, energy, the ability to negotiate and understanding the important skills of communication. Those are the kinds of skills that we value. They were provided for free in the instance to which the noble Lord has referred, and were limited in their timescale, scope and interactions with the department.

[The Deputy Speaker (Baroness Morris of Bolton) (Con)]

The noble Lord, Lord Scriven, has withdrawn.

[Baroness Jones of Moulsecoomb (GP)]

My Lords, I deeply regret that some noble Lords are dragging this debate down to the issue of unpaid advisers. This is most inappropriate. No one could object to unpaid advisers; I have used them. I have even taken advice from people on the Benches opposite; that is how low I am prepared to sink. It is not about them being unpaid or giving advice; it is about the lack of transparency and accountability. Will the Minister agree that announcements should be made about unpaid advisers so we can know it is happening and guarantee there are no leaks—which there appear to have been so far.

[Lord Bethell (Con)]

The noble Baroness makes her points extremely well. She rightly points out that we take advice from a wide variety of people. The only reason that we are talking about this today is because a transparency register is made of my appointments, which is published on GOV.UK and I would be glad to share the website link with anyone who would like to look at it more closely. The appointments of unpaid advisers follow the guidance on direct appointments from the Cabinet Office. We are scrupulous in our adherence to that guidance, and we will continue to be so in any future appointments we make.

[Lord Cormack (Con)]

My Lords, in view of what has been said by the Minister, I am extremely sympathetic to him. Could he publish a full list of all those who have given of their time, talents and money at a time of great crisis? Could he place a copy of that in the Library of your Lordships’ House?

[Lord Bethell (Con)]

My Lords, I am not sure if I can make the commitment that my noble friend asks. It is a reasonable commitment and I take it in the spirit with which it is meant, but there have been literally hundreds of people—not all of them formal, not all of them documented—who have stepped forward in the spirit that the noble Baroness, Lady Jones, has spoken of to try and contribute to our thinking, our connections and our ability to respond to this pandemic. That is a long roll of honour, of which I am extremely proud. I will give some thought to the way in which we do it, but doing it in a formal fashion in the way my noble friend describes may not be feasible or approachable.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, yesterday former Conservative Attorney-General Dominic Grieve described the Johnson Government as presiding over

“the disappearance of any standards of conduct at the heart of government”,

and said that the cronyism of administrative decisions had communicated to young people in particular a sense of government as corrupt. Given that, can the Minister be surprised that there was concern over the conduct of Mr Pascoe-Watson after he had ceased to be an adviser?

[Lord Bethell (Con)]

I always take the words and advice of former Attorney-General Dominic Grieve extremely seriously, and I value his opinion greatly.

[Baroness Wheatcroft (Non-Afl) [V]]

My Lords, I understand why the Government need as much help as possible in securing PPE in a time of emergency, but I struggle to understand why there still seems to be such a demand for public relations help. We recently learned that Kate Bingham, who is in charge of the vaccine programme, spent £690,000 on external PR help. Is it not the case that the Department of Health and Social Care has extensive PR expertise on its team? Is the problem that this Government is still too involved in fighting an election campaign rather than fighting Covid?

[Lord Bethell (Con)]

It is a reasonable question and let me be clear. This year, we are seeing a massive change in the behaviours of our entire population—from the big macro challenges such as the rule of six, social distancing and adherence to infection control procedures, through to different uses of NHS and medtech. This morning, I spent my time looking at the marketing for “111 First”—the important new way of using 111 that will give people guidance on using the service before they get to A&E. This has been possible only because of the change in the use of medtech and the changing attitude to telephones and the internet brought about by the pandemic. The noble Baroness is right that there is a big focus on communications right now, but that is because things are changing so quickly and we need to get the message across to the population in clear, persuasive terms, to provide the guidance they need to protect and save themselves.

[The Deputy Speaker (Baroness Morris of Bolton) (Con)]

My Lords, all supplementary questions have been asked.

Medicines and Medical Devices Bill

Lord Bethell Excerpts

Committee stage & Committee: 6th sitting (Hansard) & Committee: 6th sitting (Hansard): House of Lords
Tuesday 17th November 2020 Grand Committee

[Baroness Thornton (Lab)]

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

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

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

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

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

My Lords, we had an excellent debate last week on the subject of medical device information systems at Clause 16, which is critical for how we will go forward on these points. The noble Baroness, Lady Finlay, seeks in Amendment 95 to confirm that the Government will make regulations to establish the system, not that they might. We will introduce this system; the noble Baroness provides no timescale attached to the obligation she introduces. It is essential that the regulations are informed by consultation. The discretion that “may” provides allows for this consultation to be conducted. We want the regulations to be right, not rushed.

I spoke last week on Amendment 96, in the name of the noble Baroness, Lady Thornton. Devices have varying levels of risk profile; it is our intention in the first instance to use the power in Clause 16 to require all implanted devices to be recorded in information systems. Implanted devices pose the greatest risk to patients and it is right that these should be prioritised. Consultation will help us to determine which devices ought to be captured by the information system.

On Amendment 99 in the name of the noble Baroness, Lady Finlay, we recognise the importance of all the issues in Clause 16(2): that is why they were explicitly referred to. However, there may be occasions where the inclusion of provisions in regulations on all four of the issues listed here is not appropriate or necessary. For example, in future we might wish to update the types of information in Clause 16(2)(a) to include, perhaps, a new way of recording a procedure or a device. We might have no immediate need for further provision under 16(2)(b) to 16(2)(d). Without the flexibility afforded by the current drafting, we would be prevented from making proportionate regulation limited to what was necessary.

On Amendment 100 in the name of the noble Baroness, Lady Finlay, the drafting of Clause 16(2) is sufficiently broad as to say, “among other things”. Regulation is not limited to the four suggested areas for provision at subsection (2)(a) to (d).

The noble Baroness suggests mandating recording of information on any medical device implanted into the human body and the information related to any other medical device as considered necessary for patient safety. Clause 16(2)(a) is sufficient for both these matters. While they are clearly important, the addition is unnecessary.

The noble Baroness adds a requirement of patient consent for the information to be recorded in the information system. I hope that the assurances that I provided to my noble friend Lady Cumberlege last week gave her some comfort on this point. I am happy to write further on this, but the noble Baroness will know that the information systems are conditional on regulations, on which we must consult.

The noble Baroness adds in her amendment expert oversight of any information system established under Clause 16(1). I do not think this is necessary. The information system acts as a database. Where expert oversight is needed is in the assessment of patient outcomes, where information is reviewed by clinical registries operated by experts in their field.

I understand the intent behind Amendment 101. I pay tribute to the noble Baroness, Lady Masham, and my noble friend Lady McIntosh, who put it very well. The patient voice is very important in the assessment of the efficacy and safety of medical devices, but I do not wish to confuse the purpose of the information system. It is a hub; it is not a decision-making tool. There are existing routes to raise specific concerns and experience of devices.

The yellow card scheme allows patients to complete and submit reports themselves. This gives a single, clear route for patients to avoid confusion about who to tell and how, and to ensure that all necessary parties receive all data relating to patient concerns. However, data used for analysis needs to be consistent in format and terminology to ensure that comparisons can be drawn and to maximise the ability to spot common themes and issues.

Amendment 101A in the name of the noble Baroness, Lady Finlay, is unnecessary. Even though the overarching objective of the information system is medical device safety, and therefore a reserved matter, I have made it clear that I am committed to ensuring early and ongoing consultation and engagement with colleagues in Scotland, Wales and Northern Ireland as we look to develop a UK-wide system. I say for the record that it is of great importance to us all that we work together to improve the safe use of medical devices across the four nations. I strongly agree that there is a need for a centralised approach to address the existing gaps in the traceability of medical devices placed on the market. The Government have already introduced Amendment 126 to Clause 41. Therefore, it is neither necessary nor appropriate to set out the engagement or working arrangements between the four nations in regulations.

I understand that the aim of Amendment 104 in the name of my noble friend Lord Lansley is to ensure that organisations protect any information that could identify a patient, such as their name and their records. I reassure him and others who have spoken to the amendment that this information is used and shared only when it is appropriate to do so.

On the Caldicott principles and guardians, I am sure that these matters will be brought forward by others in consultation. That is the forum for addressing these points. Adherence to the Caldicott principles is expected of all NHS organisations, including—some would say most of all—NHS Digital. The Caldicott principles have been developed into the national data guardian principles that apply in England. GDPR also requires that personal information be treated in this way. All data collected by the information system will be subject to GDPR. The intention is that the medical device information system should hold patient-identifiable information. Information that is de-identified will be shared with the relevant organisations to ensure the protection of that patient. It is unlikely that there would be any requirement to share patient-identifiable information with other organisations. MDIS would be programmed to know, when provided with notices by MHRA or others, that action needed to be taken and which patients it applied to.

Parliament oversees data protection legislation. The standards are very high, and we have no intention of lowering them. I do not think, therefore, that having regard to the Caldicott principles is necessary or would add anything material to the legal constraints that would apply to this information. Of course, we have no intention of doing anything contrary to those principles through this legislation. Regulations under Clause 16 will be subject to public consultation. Under GDPR, they are also subject to the requirement to consult the Information Commissioner’s Office. We have already begun discussions with the Information Commissioner’s Office on this basis.

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[Baroness Jolly (LD) [V]]

My Lords, these amendments relate to consultation. My noble friend Lord Sharkey’s Amendment 129, to which I have added my name, specifies some people or classes of people who should be involved but who have in the past been omitted—patients or representatives of patient groups, medical research bodies, the pharmaceutical industry and academic researchers.

My noble friend asked a good question of the Minister about why the consultation in Northern Ireland is with the department and not the Minister. The Select Committee on which I sit has engaged with the Northern Ireland Government in various areas of policy. They often do things well, but they do it their way.

The amendment also calls for details about consultation timings, consultees and proposed publication details. The point the noble and learned Lord, Lord Mackay of Clashfern, made about contacting patients was a really good one. His remarks follow on from those of the noble Lord, Lord Hunt of Kings Heath. Many consultations involve patients, but they are often with what I might call professional patients. This is not a derogatory statement, but sometimes they are the usual suspects and the story does not change. That can lead to a loss of a total patient view.

Government Amendment 126

“requires a relevant authority to carry out a public consultation before making regulations under any provision of Part 1, 2 or 3, and to set out the authority’s assessment of any matter to which the authority must have regard in making the regulations”.

It also requires the Secretary of State

“to consult the devolved administrations in relation to regulations under clause 16 (1).”

In this morning’s useful meeting—I join others in thanking the Minister for hosting such a fascinating session—we touched briefly on Scotland, Wales and Northern Ireland. Would the Minister confirm that the devolved nations are being consulted on their involvement in their use of our registries, and maybe ours of theirs?

Amendments 125, 127 to 130 and 132 all relate to consultation when making regulations, including, but not limited to, the devolved Administrations, patient groups, various healthcare organisations and academics. Consultation is key to all this, with clinicians, who will give you one set of information, but even more so with patients, who will give you a different, richer, more detailed dataset.

[Lord Bethell (Con)]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

I have received a request to speak after the Minister from the noble Lord, Lord Hunt of Kings Heath. I am not clear whether the noble Lord, Lord Patel, also wishes to do so. Perhaps that could be clarified.

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[Lord Bethell (Con)]

My Lords, I acknowledge the noble Lord’s point that the Bill puts huge emphasis on the effective and impactful nature of our consultation arrangements. That is very much our approach. He is entirely right that these consultations are key. That is why we have sought, as I have this afternoon, to give reassurances about our approach to consultation.

On the noble Lord’s point about the listing of groups, we have in mind two considerations. The first is that, by listing one group and not another, you assign a degree of legislative weight on one group and not the other. That is an unfortunate result of a listing process such as he describes. Secondly, as I have said, not all the groups that you could list in one part of the Bill would be relevant for all parts of the Bill. For that reason, we are reluctant to provide lists of groups that technically have to be consulted on every aspect of the Bill.

I take the noble Lord’s point that broad, effective and deep consultation is critical to the effective implementation of the Bill and to the drafting of thoughtful and effective regulations. All those involved in the Bill, including the department and me, very much agree with that point. That is why I tabled the amendment.

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

I have not received any further requests to speak, so I call the noble Baroness, Lady Wheeler.

[Baroness Wheeler (Lab)]

I thank the Minister for his extensive and helpful response, particularly on the comments made by my noble friend Lord Hunt about the groups that are consulted. This has been an excellent debate and I have little to add, as noble Lords put forward the issues so ably, in particular on the importance of listening to patients and patient representatives so that the consultation is meaningful and well thought through, given the enormous powers that are in the Bill and will be set out in the regulations. It is timely for my noble friend to remind us of the context of the DPRRC and Constitution Committee reports. I asked the Minister to consider whether Clause 41 should specifically include reference to consultation with the devolved authorities. If he could come back to me on that, that would be helpful. I also asked some questions about his correspondence, which I hope he will agree to follow up.

[Lord Bethell (Con)]

On the question why the government amendment is being made to Clause 41 rather than Clause 16, which I think is what the noble Baroness is asking about, Clause 41 is concerned with consultation. It is important that consultation requirements are provided for in one place, as that assists with clarity and understanding. The legal effect is the same, irrespective of where in the Bill the obligation to consult the devolved Administrations when making regulations under Clause 16 is found.

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Moved by

[Lord Bethell]

109: Clause 35, page 19, line 33, at end insert—
“(4A) The Secretary of State may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of medical devices.”Member’s explanatory statement
This amendment makes clear that information held by the Secretary of State in connection with medical devices can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.

--- Later in debate ---

I hope that the Minister supports this amendment and, if he cannot, that he will commit to bringing an amendment back on Report which recognises the patient voice and influence within the NHS, and that a new patient safety commissioner would strengthen that voice and the NHS enormously by bringing a focused perspective to improving patient safety.

[Lord Bethell (Con)]

My Lords, I start by profoundly thanking my noble friend Lady Cumberlege. It has not escaped the notice of anyone in this Grand Committee that her amendment has the support of a very large number of noble Lords, including the noble Lords, Lord Patel and Lord Hunt, and the noble Baronesses, Lady Jolly and Lady Thornton. Many Members spoke in favour of her report’s recommendation at Second Reading, and I expected that we would spend time on these matters now.

Let me say at the outset that the Government take very seriously the report of the Independent Medicines and Medical Devices Safety Review, led by my noble friend Lady Cumberlege. We are absolutely determined to learn from it. We are taking time to carefully consider the report and all its recommendations before we respond, which is reasonable. Given the important issues it raises, it is only right that the report gets due consideration. It is right that, on a report of this length and breadth, we take the time to do this properly.

At the heart of the review are harrowing stories of hundreds of people and their families. It is right that the Government have made an unqualified apology on behalf of the health system to all the individuals affected by this report.

I shall say a word about the pause in the use of vaginal mesh in the treatment of prolapse and incontinence which was introduced in mid-2018. As my noble friend Lady Cumberlege rightly observed, the pause introduced a period of high vigilance, restricted practice to ensure that NICE guidance was followed. A blanket ban on the relevant procedures was not recommended as there needed to be some exceptions within the pause. I am aware of the six conditions that must be met before the pause can be lifted. The majority of the six measures are in hand. NHSE is working closely with providers to set up specialist mesh removal centres and is working in partnership with the British Association of Urological Surgeons and the British Society of Urogynaecology to ensure that there is a consistent approach to informed consent and shared decision-making in these centres with clear and accessible information available for patients. I am aware that a data solution is yet to be fully implemented, but I reassure noble Lords that I understand that NHS Digital, working with NHSX, has put together a programme of work to establish an information system to collect surgical implants and devices data from all NHS and private provider organisations, starting with mesh-related procedures, and that this work is in the pilot stage with a view to establishing a medical device information system.

We recognise that Amendment 117 stems from the centrepiece recommendation of that bold and far-reaching report to establish an independent patient safety commissioner. He or she would promote the interests of patients and other members of the public in relation to the safety of medicines and medical devices. We recognise that the role would be to help patients navigate the healthcare system architecture and to troubleshoot problems and that, as my noble friend put it in her report, the commissioner could be a golden thread tying our complex health system together in the interests of patients and the public. We recognise the significance of the intention of this amendment. We wholeheartedly accept that listening to patients is a key step to preventing the sort of issues that the report by my noble friend Lady Cumberlege has highlighted.

We accept that policymakers, the NHS, private providers, regulators, professional bodies, pharmaceutical and device manufacturers need to do more to engage patients and families, and to recognise and use their insights as a vital source of learning. It is only by listening to patients, their families and staff that we can learn from mistakes and continually improve. On this point, it has been imperative that we listen, and I am listening very carefully today to the points made by colleagues about the arguments for a commissioner and how this might sit within the wider system. I will continue to listen.

However, before I turn to Amendment 117, allow me to explain why patient safety is an unwavering commitment for the Government and the measures we are taking to embed patient safety throughout the NHS. These include putting a positive learning culture at the heart of the NHS and ensuring that providers are listening to those who raise concerns at the time they are raised, whether by patients, their families or staff, and that they show empathy and sensitivity when they respond. This is a culture where patients are listened to in the first place and not one where they feel they must resort to a third party in order to be heard.

Following the tragedy of Mid-Staffs, which the noble Baroness, Lady Thornton, referred to, and some other very concerning cases, we have overhauled the infrastructure underpinning safety and quality in the past decade. That includes taking steps to help staff speak up when they see things going wrong. A culture that listens and responds to concerns in the first place is crucial if the right lessons are to be learned and errors are to be minimised. Our measures include establishing: the Healthcare Safety Investigation Branch to examine the most serious patient safety incidents and promote system-wide learning; medical examiners to provide much-needed support for bereaved families and to improve patient safety; a duty of candour so that hospitals tell patients if their safety has been compromised and apologise; and protections for whistleblowers and freedom to speak up guardians across all trusts, supported by a national guardian.

In addition, the NHS people plan for 2020-21 sets out our vision for a health service that is compassionate and inclusive, that is not hierarchical and where people are listened to. We know that implementing change can be a slow and complex process for many organisations and individuals. Healthcare will always involve risks, but they can be reduced by analysing and tackling the root causes of patient safety incidents.

However robust our regulatory and oversight system is, ultimately, improving patient safety requires those at the executive level of our health service to act just as much as individuals involved in patient care. It is why in 2019 we commissioned the NHS national director of patient safety, Dr Aidan Fowler, to publish a new NHS patient safety strategy. Substantial programmes are planned which include: a framework to support patients to contribute to their own safety by having patients or their advocates on all safety-related clinical governance committees in NHS organisations; a requirement for all NHS organisations to identify a specialist to lead on patient safety; the first ever system-wide patient safety syllabus and training for all staff so that they have the knowledge to make care safer themselves; a new patient safety incident response framework to improve the handling of patient safety investigations in the NHS; a successor to the national reporting and learning system to support safety improvement and help the NHS when things go wrong; and a national patient safety improvement programme to prioritise the most important safety issues in the NHS, including medicines safety.

Implementation of the 10-year NHS patient safety strategy is being led by a team that is more than 50 strong. At its core, the strategy seeks to significantly improve the way the NHS learns, treats its staff and involves patients. The strategy seeks to ensure that all healthcare organisations in England adopt a different focus for patient safety that is based on culture and systems. NHS England and NHS Improvement have assessed that getting patient safety right could save 1,000 lives and £100 million in care costs each year from 2023, with the potential to reduce claims provision by around £750 million a year by 2025. The NHS patient safety strategy will be refreshed each year to support our ambition of cementing patient safety into the everyday fabric of the NHS and encouraging a safety and learning culture. NHS safety bodies are doing more to involve patients to better understand issues that give rise to patient safety concerns. Let me give a couple of examples.

The Healthcare Safety Investigation Branch has established a citizen partnership panel to bring in patient insights and ideas for referrals or improvements in HSIB’s investigations. The experiences of patients and their families are central to the regulatory approach of the CQC and its future direction. The MHRA has begun a substantial programme of work to drive forward change in its culture, where a key priority is listening and responding to patients.

Lest we forget, the healthcare system architecture is complex. This means that patient safety regulation is prone to overlaps of remit and gaps between oversight bodies. It is why our consideration of the recommendations by my noble friend Lady Cumberlege includes how a patient safety commissioner would interact with other bodies across the healthcare landscape, ensuring that they could make a difference without creating duplication or confusion.

With this in mind, although Amendment 117 from my noble friend Lady Cumberlege, the noble Lords, Lord Patel and Lord Hunt, and the noble Baroness, Lady Jolly, would give the patient safety commissioner considerable latitude about how he or she would operate, it is without detail about how the commissioner would interact with other bodies. For example, proposed new subsection (5)(e) would allow the commissioner to receive direct reports from patients and the public. However, the CQC, the Parliamentary and Health Service Ombudsman and the MHRA, among many others, are all open to receiving direct reports from patients and the public. They have a responsibility to listen to complainants whatever the cause of the complaint may be. These bodies also have their own routes for reporting. For example, adverse incidents relating to medicines and medical devices are reported through the MHRA’s yellow card scheme. Proposed new subsection (5)(e) does not address how a new route for patients to report safety concerns would mitigate the risk of drawing patients away from reporting these incidents to the MHRA or of causing a delay in the MHRA receiving this vital information or receiving it at all.

Proposed new subsection (7) enables the commissioner to require information from public bodies and others for the purposes of producing and laying before Parliament reports regarding patient safety. Although this power does not, as we might expect, extend to requiring information for the purposes of fulfilling the commissioner’s other functions, it is otherwise broad, because it would apply to both public and private bodies, and individuals, and could involve requests for sensitive personal data and confidential commercial information that these bodies may not agree are reasonable for the purposes of the commissioner’s public reports.

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[Baroness Thornton (Lab)]

I am grateful to the Minister for that detailed answer, but as far as I can see, it underlined the point about the fragmentation of patient safety. He is undoubtedly right about the need to change culture. Will the Minister look at this again, because I mentioned the three inquiries in the past 20 years that I knew about very well, and every one of them said very similar things to what the Minister has said? None of them has produced the kind of support that one would want for patients or been the catalyst required here from the patient safety commissioner. Will the Minister go back and think about this again?

[Lord Bethell (Con)]

I take the encouragement of the noble Baroness to heart. I would be very happy to think further on it. She makes a very good point: we know about the terrible incidents of the past and the very substantial responses that they had. I share with her the frustration that these problems continue to arise. For that reason, as I said, we are looking for a really thoughtful, considered response to the review overall. As I said in my earlier remarks, the case for a patient safety commissioner is one that we are looking at. I listened to absolutely everyone who has spoken in its advocacy, but we do not regard it as a silver bullet or a single point of catalysis, which I do not think the noble Baroness was alluding to. We are looking for a broad response to the review that would ultimately take on all the different points that the noble Baroness and her review team have made.

[Baroness Cumberlege (Con) [V]]

My Lords, I will come to the Minister’s summing up at the end, but I thank all noble Lords who have taken part in this debate. I have not heard anything really contrary or disturbing against a patient safety commissioner. It has been supported, and I am very grateful for that.

I first thank the noble Lords, Lord Patel and Lord Hunt of Kings Heath, and the noble Baroness, Lady Jolly. I know that the noble Lord, Lord Patel, has been a champion of safety both in Scotland and in this country. I share his impatience. He considered some of the interesting reports that have been produced and we hope that they all have made a little difference—but not enough. He is so right to say that we are searching for independence, as other noble Lords have mentioned. The person who we appoint to this position is so important. We do not want a patsy or someone who is just going to do what the department and Ministers want. We want an independent voice. I thank all those who also talked about a patient safety commissioner and the Children’s Commissioner, who, as we all said, has been outstanding. I also thank the noble Lord, Lord Patel, for his revealing statistics, which were interesting.

I understand the cynicism of the noble Lord, Lord Hunt of Kings Heath, about NHS England. I say just one thing about it, but I should have declared my interest at the start of the debate because I am employed by NHS England in the context of maternity services. The chief executive took our report, Better Births, and said, “I am giving you five years to implement it”. He gave us the people, resources and everything else. We were making real progress until March. The virus has really knocked us back—we did not expect it. However, in the four years that we have completed, we have changed much of the culture within maternity services and improved the lot of many women. We have not had that response from the Government on this report. They have not said, “We will give you five years and some resources. See what you can do”. No, they have been silent. Today, the Minister told us a bit about what he has been doing. However, none of that was news to us. We know all that already.

Moving on, I refer to what the noble Lord, Lord Hunt of Kings Heath, said about the tension within boards. I chaired the Brighton health authority board when the Grand Hotel was bombed. It was a tragedy—lives were lost—but when one looked at the whole system, it worked. Why was that? It was because we had a good leader in A&E who conducted a rehearsal three weeks before the bombing. That rehearsal paid off. Preparation is extremely important. The noble Lord was of course right about the financial problems that must be weighed up within trusts.

We are so lucky to have in our House my noble and learned friend Lord Mackay of Clashfern, a previous Lord Advocate and Lord Chancellor. I remember working with him on debates about the family and all sorts of matters. If you want somebody with true wisdom, understanding and foresight, you go to him. He has done it all, knows about it and always has such integrity. I thank him very much for his support and his impatience, which I share. We know today that babies are being born deformed. One in two have a chance of having a disabled child if they are on sodium valproate, and they do not know about it. We are impatient. We do not want to see more of that. We want to see safety become a reality.

My noble friend Lord O’Shaughnessy has, of course, been a Minister in the House and he knows the tensions and difficulties. One of the things that I know about him is that he listens to patients: he takes time out to do that. He appreciates, almost more than all of us, how people have waited for decades in terrible conditions, suffering terribly. I know that he has done a lot with sodium valproate and the patient groups there, and I thank him for that. What he was telling us about Jeremy Hunt and the way that this review was first commissioned was really helpful, because Jeremy Hunt set the parameters. He was invited to take on three different areas by the Prime Minister, Theresa May. It was really her initiative first, and then Jeremy worked extremely well. I am of course delighted that he appointed me to chair the team.

I want to say a word about the noble Lord, Lord Blunkett. I am very pleased that he is taking part in this Committee; he apologised for not being at Second Reading. Whenever he comes in on a debate, we welcome him. Again, with him having been a really strong leader in his own area and then in the Commons, it is really good to have had him join us today. He talked about the Health and Safety Executive and how we have to work with it. He is of course right.

The Minister, in his summing up, asked who this patient safety commissioner is going to work with. We do not know exactly—of course not. He can read the amendment, which sets out quite a lot. He can read the report and see there what we were thinking about, but of course this needs more work. In fact, one of the members of our team said to us, “Do not lose out on the coroners’ courts; you learn a lot from them”. Her husband is a judge, so she knows a bit about it. We are saying that you have to map the whole horizon and see where things are not quite right. Why is something going wrong? That is something we ought to look at more carefully.

It is about listening to patients but, much more than that, it is about working with all the different healthcare systems. My noble friend Lord Sheikh and others talked about the NHS. We are thinking much more broadly than the NHS. We are thinking about it, of course, and we know it has done a fantastic job with the coronavirus, but we are also thinking about private providers. I was very interested that the noble Baroness, Lady Masham, brought in private providers. We need to think about other public bodies and certainly about the royal colleges, the pharmaceutical and devices industries, the manufacturers and of course the policymakers—the politicians. I appreciate that it is a broad area but that is the problem with it at the moment: it is disjointed and siloed, it is unresponsive and defensive. We need some person who is going to get into all of that and call all the organisations to account—encourage them but call them to account when things are not working right.

European Qualifications (Health and Social Care Professions) (EFTA States) (Amendment etc.) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 16th November 2020 Lords Chamber

Moved by

[Lord Bethell]

That the draft Regulations laid before the House on 17 September be approved.

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

My Lords, these regulations relate to the recognition of professional healthcare qualifications in the UK and social work qualifications in England. They are part of the Government’s preparations for the end of the transition period. As noble Lords will be aware, the Government have signed agreements with the EU, the three EEA EFTA states and Switzerland in relation to the UK’s withdrawal from the EU. These agreements include provisions that protect the rights of EEA EFTA state professionals with qualifications covered by the directive, and Swiss nationals living and working in the UK, and vice versa.

 European healthcare professionals have played, and will continue to play, an important role in the delivery of health and care services in the UK. We have been clear throughout the EU exit process how valued these professionals are and how we would like them to remain in the UK. It is for that reason that the previous SI, which we are amending today, maintains automatic recognition of relevant European healthcare qualifications for a limited time after the end of the transition period. It is also why a number of health professions, including doctors, nurses and social workers, are on the shortage occupation list.

These regulations specifically implement the agreements that we have signed with Switzerland and the EEA EFTA states, and as such affect a very small number of professionals. For example, on 30 June 2020 there were 80 doctors and 32 nurses and health visitors among a total of 134 Swiss healthcare professionals working in the UK. This legislation also makes some minor amendments to the provision for EEA EFTA-qualified professionals, of which there were 230 working in the UK on 30 June this year.

While the number of professionals impacted is very small, it is important that there is legislation in place to protect the rights of these healthcare workers wishing to come and play a part in the UK healthcare workforce. On 14 September 2020, the House considered legislation brought forward by the Department for Business, Energy and Industrial Strategy which set out arrangements for the recognition of professional qualifications from Switzerland and the EEA EFTA states. These regulations now cover a similar area. They implement the Swiss citizens’ rights agreement and the EEA EFTA separation agreement, in relation to the recognition of professional qualifications for healthcare in the UK, and social work in England.

Regarding the current framework, I will remind noble Lords of the background to the recognition of professional qualifications, or RPQ. The current system for this recognition is derived from EU law. It allows UK professionals to have their qualifications recognised in the EEA and Switzerland, and vice versa, with minimal barriers. There are seven professions where standards are harmonised under the relevant EU directive. This means that qualifications must comply with minimum agreed standards. Five of these harmonised professions are health professions: doctors, nurses, midwives, pharmacists and dentists. The recognition arrangements under the directive have supported the movement of European health and care professionals to the UK. Between 1997 and 2019, more than 77,000 EEA and Swiss qualifications in the professions of doctors, nurses, midwives, dentists and pharmacists have been recognised in the UK. At the end of the transition period, the EU directive will cease to apply to the UK and the mutual recognition of professional qualifications will end.

Last year, in preparation for the UK leaving the EU, Parliament passed regulations to amend the domestic law that implements the current EU system for RPQ. This included regulations in relation to recognition arrangements for health and care professional qualifications, namely SI 2019/593. These regulations, which come into force at the end of the transition period, include provisions which, first, ensure that healthcare qualifications which are currently recognised continue to be recognised automatically, for up to two years after the end of the transition period. Secondly, they protect previous recognition decisions. Thirdly, they allow applications for recognition submitted before the end of the transition period to be concluded. Fourthly, they remove the provision for healthcare professionals to deliver temporary and occasional services in the UK once such current registration comes to an end.

Since the passing of the previous regulations, the Government have secured agreements with Switzerland—the Swiss citizens’ rights agreement—and the EEA EFTA separation agreement. These agreements go further than the arrangements set out in the regulations that were passed last year. Therefore, the regulations before the House today amend the previous SI to implement the terms of the Swiss and EFTA agreements.

 I will explain the main changes. First, they provide a four-year period of continuation of the automatic recognition system for Swiss nationals. Secondly, they allow Swiss healthcare professionals to continue to provide temporary and occasional services under certain conditions. Thirdly, these regulations will require UK regulators to co-operate with their EEA EFTA state and Swiss counterparts to ensure that EEA EFTA state EU-qualified professionals and Swiss nationals whose professional qualifications are recognised are treated on the same basis as UK nationals. These arrangements will be reciprocated by the EEA EFTA states and Switzerland respectively.

These regulations also make a minor amendment to ensure that the frameworks for RPQ will function as intended after the transition period. This makes sure that GP qualifications obtained before the reference date specified in the mutual recognition of professional qualifications directive are recognised in the same way as specialist medical qualifications obtained before that date, and are not eligible for automatic recognition.

UK regulators of healthcare professions have been consulted on an informal basis throughout the development of RPQ EU exit legislation, including these regulations. The devolved Governments were consulted regularly throughout the process. They are supportive of our approach and consent has been given by the Scottish Parliament to take this legislation forward.

These regulations are necessary to implement the Swiss citizens’ rights agreement and the EEA EFTA separation agreement, in respect of the recognition of professional qualifications. These agreements were signed after the passing of previous EU exit legislation on this matter. These regulations enable health and social care professionals and businesses to prepare for the end of the transition period. I commend them to the House.

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[Lord Bethell (Con)]

My Lords, I am enormously grateful for the searching questions of the noble Baronesses. They have covered an enormous amount of ground, and I am not sure whether I can cover it all in my remarks. I will endeavour to write to them on some of their specific questions.

The noble Baroness, Lady Walmsley, asked a large number of pertinent, relevant and searching questions on dentists. We are extremely conscious of the provision of dentists during Covid, the ongoing commitment to improving Britain’s dentistry and the significant contribution of those from overseas to the dentistry practice. Provisions such as this SI and many others like it are there to ensure that dentists from overseas continue to be welcome in the UK and that we can meet the needs of the British public. I would be happy to write to the noble Baroness with some detailed answers to her questions.

The noble Baroness, Lady Jolly, rightly referred to the challenge of recruitment in health and social care, which we take extremely seriously. We have put in place an enormous marketing campaign to build the substantial and important NHS brand. We are recruiting more than ever before, and rather than reducing numbers, Covid has led to an increase in people stepping forward.

As I said in my opening remarks, we remain committed to workers from overseas. They make an invaluable contribution to health and social care, and nothing that we are doing through these provisions, the immigration Bill or any of our other provisions in any way diminishes that enormous contribution. As reciprocal arrangements will be subject to negotiated outcomes, I cannot make the commitments that the noble Baroness requested. However, I assure her that the regulations put in place in these statutory instruments and the others like it ensure that registration is possible and is part of our commitment to those who come to Britain from overseas to work.

I emphasise that the changes contained in these regulations are essential to ensuring that the UK meets its commitments, not only to overseas workers in general, but also, specifically, under the Swiss citizens’ rights agreement and the EEA-EFTA separation agreement. In response to the noble Baroness, Lady Thornton, that is part of a general commitment to those who come to Britain from overseas to work in health and social care. The UK Government are committed to protecting citizens who benefit from rights under the Swiss and EEFA agreements, many of whom make valuable contributions to the UK workforce. These regulations maintain existing rights for EEA, EFTA and EU-qualified workers and Swiss nationals beyond the end of the transition period and ensure that the UK’s existing EU exit regulatory frameworks for RPQ will function effectively at the end of the transition period.

I am enormously grateful for the support shown by many noble Lords for these measures, and I commend these draft regulations to the House.

Motion agreed.

Reciprocal and Cross-Border Healthcare (Amendment etc.) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Monday 16th November 2020 Lords Chamber

Moved by

[Lord Bethell]

That the draft Regulations laid before the House on 30 September be approved.

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

My Lords, this instrument amends regulations from 2019 to remove provisions that have now been superseded by the protections for people contained within the withdrawal agreement. It makes some technical fixes to reflect this and ensures that the statute book is fit for purpose. It also provides protections for people benefiting from the cross-border healthcare directive, as the directive was not carried forward in the withdrawal agreement.

Before I turn to the details, I will start with an overview of current reciprocal healthcare and our steps to prepare for the end of the transition period. Reciprocal healthcare arrangements with the EU have continued during the transition period. This means that people will see no changes in their access to healthcare for the rest of the year. From 1 January 2021 healthcare arrangements will also continue for those within the scope of the withdrawal agreement. I hope that this provides much welcome reassurance. State pensioners and workers who have moved from the UK to the EU or vice versa, and are residing there before 31 December 2020, will have lifelong reciprocal healthcare rights for as long as they remain in scope of the agreement. That includes the use of the European Health Insurance Card, the EHIC.

The agreement also protects those who are in the EU on a short stay at the end of the transition period. For example, someone who travels to an EU country before the end of the year can continue to use their EHIC there until they return to the UK. UK students on a stay in the EU, beginning a course of study before 31 December 2020, can also use their EHIC in that country for immediate and necessary healthcare for the duration of their course. Finally, people receiving planned treatment can commence or complete their treatment if authorisation was requested by 31 December 2020. All this provides much-needed certainty for UK nationals already living in the EU and vice versa.

As noble Lords are aware, future reciprocal healthcare arrangements are subject to ongoing negotiation with the EU. We understand the value of access to healthcare when travelling on holiday or for work, and I know that this is particularly important for those with pre-existing or long-term conditions. This is why the UK has been clear that it wishes to establish necessary healthcare arrangements such as the EHIC for tourists, short-term business visitors and service providers. I am sure that noble Lords will be aware that these discussions are continuing. I reassure them that, should these discussions not conclude with a healthcare agreement, we will continue to look at this issue carefully.

Should we not achieve an EU-wide deal, we would seek to agree reciprocal arrangements with EU and EEA countries bilaterally. But we cannot start these discussions until the negotiations with the EU have concluded. The one exception to this is of course Ireland. I am very pleased to report good progress on agreeing a healthcare arrangement with Ireland, under the common travel area. These arrangements will mean that residents of the UK and Ireland can continue to access necessary healthcare when visiting the other country, and it will cement co-operation between UK and Irish healthcare providers.

The instrument that we are debating today is a technical instrument to update legislation made in 2019. This now needs updating to reflect the terms on which we are leaving the EU. We need to ensure that our legislation is ready for the end of the transition period. We also need to ensure protections for those accessing cross-border healthcare on an ongoing basis at the end of the year, as this is not covered in the withdrawal agreement.

In April 2019 the Government made three statutory instruments to correct deficiencies in retained EU law relating to reciprocal healthcare. This was part of the UK’s preparations for leaving the EU without a deal. Those instruments made provision to revoke that body of retained EU law, protected people in the middle of a course of treatment and provided a mechanism for the UK to maintain bilateral reciprocal healthcare arrangements on a transitional basis until 31 December.

Some of this has now been superseded by the transition period and the withdrawal agreement protections. If we do not agree this instrument, the retained law will be incoherent and unworkable. There will also be uncertainty over protections for patients in the middle of a course of treatment.

As such, the first change our SI makes is a series of consequential and technical amendments to four EU exit instruments to make them workable and coherent. These instruments are: the Social Security Coordination (Reciprocal Healthcare) (Amendment etc.) (EU Exit) Regulations 2019; the National Health Service (Cross-Border Healthcare and Miscellaneous Amendments etc.) (EU Exit) Regulations 2019; the Healthcare (European Economic Area and Switzerland Arrangements) (EU Exit) Regulations 2019; and the Health Services (Cross-Border Health Care and Miscellaneous Amendments) (Northern Ireland) (EU Exit) Regulations 2019. The second change is that this SI updates EU references in NHS legislation that will no longer be appropriate at the end of the year. Thirdly, as I mentioned, it will clearly set out transitional protections for people accessing healthcare under the cross-border healthcare directive.

The directive gives patients the right to receive healthcare in another EEA country and receive reimbursement from their home country. It is separate from broader reciprocal healthcare under EU regulations and was not included in the withdrawal agreement. This means that the directive will no longer apply from 31 December 2020, and it is therefore important that patients who are in the course of being treated are appropriately protected. This instrument will specifically allow the Government to fund patients in the middle of treatment, or who have already applied for authorisation, at the end of this year.

Turning to the impact on industry, as this instrument proposes no significant changes to the current regulatory regime, there would be no significant impacts on industry or the public sector. As this instrument makes technical amendments and does not introduce new policy, we have not conducted an impact assessment.

The instrument also makes provision in relation to Northern Ireland and Wales. The devolved Administrations have been consulted. There has been excellent engagement between the department and the devolved Administrations and I am confident that we have clear arrangements in place.

I am pleased to say that we have worked openly and collaboratively with NHS England and NHS Improvement, as well as the NHS Business Services Authority. They are our key delivery partners and have continued delivering their day-to-day operations, such as issuing EHICs to people, while making changes to successfully implement the withdrawal agreement.

In summary, the overarching aim of the instrument is to ensure that UK legislation is functional and reflects the withdrawal agreement. It also ensures that there will be appropriate protections for people accessing treatment under the cross-border healthcare directive at the end of the year. I beg to move.

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[Lord Bethell (Con)]

My Lords, I express admiration and gratitude for the stamina of the noble Baroness, Lady Thornton, for sitting through this debate several times. I have also sat through it several times. I fear that some of my answers will be the same as those the noble Baroness and others will remember.

I am grateful for this debate. It is a quite reasonable and touching reminder of a key fundamental that travel is massively valued, particularly by those who travel for work, for study and to see relatives, but also by the population generally. Travel is of huge personal and financial value and protecting your health when you travel is incredibly important. People have a close association with that and are naturally deeply concerned about it. I agree with those noble Lords who emphasised the importance of these arrangements and in no way do I undervalue the importance of the EHIC programme and its successor to the British public.

In the withdrawal agreement we have a robust framework for some reciprocal rights that include significant long-term and traditional protections for EU and UK nationals. This piece of legislation is very much in that spirit. It is there so that UK legislation remains functional by reflecting the withdrawal agreement and the transition period and ensures that there are appropriate protections in place for those accessing healthcare under the cross-border healthcare directive. As veterans of this area will know—I apologise if this creates a sense of déjà vu—I remind noble Lords that the changes in this instrument do not concern the future relationship with Europe. The UK has made it very clear, and we continue to work on the fact, that we want to agree clear arrangements for providing healthcare cover for tourists, short-term business visitors, service providers and for all manner of British people who are travelling to the EU and vice versa.

However, any agreed arrangements will be entirely subject to the outcome of those negotiations. There is nothing I can do at this Dispatch Box to answer the great many perfectly valid but completely unanswerable questions that have been put about what those future arrangements might look like. However, I can update the House: the UK has had constructive discussions with Switzerland and the EEA/EFTA states of Norway, Iceland and Liechtenstein on our future relationship, including social security co-ordination and reciprocal healthcare. Those are promising and reflect well on our conversations with the EU. The progress of those discussions is, however, linked to the outcome of the EU negotiations on social security co-ordination, so I cannot offer concrete guarantees in that department.

To answer a point made by the noble Baroness, Lady Thornton, some people will be eligible for a UK EHIC under the terms of the withdrawal agreement. A new EHIC has been developed for those who are eligible, including people living, working and studying in the EU before the end of the transition period. We made that very clear very early on. Anyone with an S1 form or studying in a member state can apply for the new EHIC on the NHS website. For those not covered by the withdrawal agreement, the EHIC may not be valid from 1 January 2021, as the noble Baroness rightly pointed out. The Government are open to working with the EU to establish necessary healthcare arrangements that provide healthcare cover for tourists, short-term business visitors and service providers, but those conversations have not been finalised.

Future healthcare cover for tourists is subject to the future relationship. I understand that it is extremely frustrating not to be able to find exactly what that will look like. I acknowledge that one group which is particularly concerned will be those with pre-existing conditions; they will find it the most challenging to find the right travel insurance if there is no arrangement with the EU on necessary healthcare. This is something we are looking at closely. On a practical note, we know that getting insurance can be more difficult for those with long-term conditions. To support people, the Money Advice Service has recently launched an insurance directory for people with a serious medical condition, which brings together specialist firms with the aim of making it easier to find travel insurance that provides the right health cover. I understand that that service is proving of value.

In response to my noble friend Lord Bourne, communication has been incredibly important and we have gone about it in an energetic way. We have sought to prepare citizens for the change at the end of the transition period with advice tailored for different audiences, helping them to understand their choices and to act in their own best interests. Information is available and has been updated regularly on the NHS pages and GOV.UK to ensure that people are clear about their reciprocal healthcare rights. The Foreign, Commonwealth and Development Office has been leading a campaign, supported by DHSC reciprocal healthcare advisers, to UK-insured people living in the member states, and my understanding is that those communications have been effective.

The noble Lord, Lord Greaves, asked about readiness to implement the withdrawal agreement. I reassure him that the DHSC has made good progress, working openly and collaboratively with other social security departments and its operational delivery partners in NHS England, NHS Improvement and the NHS Business Services Authority, to ensure that reciprocal healthcare arrangements will be successfully implemented for those covered by the agreement. I also confirm that UK S1 holders in the EU and UK students studying abroad can now apply for their new EHIC under the withdrawal agreement.

The noble Baroness, Lady Jolly, asked about Ireland, and it is good news that we seem to have made progress on our arrangements for Ireland. The UK and Irish Governments have been discussing future arrangements for healthcare co-operation within the common travel area. Great progress has been made in these talks. These arrangements will ensure that residents of the UK and Ireland will continue to be able to access necessary healthcare when visiting the other country and benefit from co-operation between UK and Irish healthcare providers, regardless of the outcome of the negotiations with the EU. The example the noble Baroness gave of ambulances travelling across the border was very powerful.

These arrangements build on previous commitments that UK and Irish citizens who are living in the other country will continue to be able to access healthcare on the same terms as local citizens. The Healthcare (European Economic Area and Switzerland) Arrangements (EU Exit) Regulations 2019, which we debated previously, provide the mechanisms to implement these arrangements, so there should be no interruption in healthcare arrangements between the UK and Ireland.

The noble Lord, Lord Willis, asked about money reclaimed from other countries. That amount has grown substantially over the last five years. I cannot give the precise number that the noble Lord asked for, but the amount recovered from overseas healthcare visitors has risen to £760 million in 2019-20. That is a substantial amount, but we are continuing to work to make sure that all that money is reclaimed effectively.

These essential measures are being put in place to protect those who seek to travel abroad. For that reason, I beg to move.

Motion agreed.

Covid-19 Update

Lord Bethell Excerpts

Thursday 12th November 2020 Lords Chamber

[Baroness Jolly (LD) [V]]

I thank the Minister. I am going to address testing and tracing. He may not have answers but I should be grateful if he could write to me. There have been more than 10 million downloads of the NHS Covid-19 contact tracing app. There have also been many complaints of Bluetooth draining batteries. I second those. Will he confirm whether there is a solution in the pipeline for that issue? If people do as I do and just switch off Bluetooth, the system will not work. How many of these app users are active? If 10 million people are actively telling the world where they are and are checking in and out of where they have been, that is wonderful. But if they do not do so, it is not terribly helpful.

Critically, how many people have been triggered via the app to isolate? Of those, what proportion have had their isolation checked and by whom? Testing is quick and easy but the delay in response time is unhelpful. Swab processing time is not reducing due to the increase in the number of swabs, and labs are taking longer. Is there yet sufficient capacity, and how many staff are being trained weekly to take on the extra capacity? Can the Minister indicate the cost of taking a swab and getting the results back to the individual? Finally, will he confirm when he expects to move to lateral flow tests, which are much quicker and would transform the lives of the staff of care homes, their residents and visiting families?

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

My Lords, I am extremely grateful for the thoughtful questions of the noble Baronesses. I shall try to answer them as completely as I can but will write on any that I have omitted. As regards the questions about students, the programme of works with universities is extremely ambitious. I pay tribute to vice-chancellors and university administrations for working extremely closely with the Government, with the test and trace service and the DfE to mobilising the necessary arrangements in order to achieve the return home for Christmas.

This will include a large amount of mass testing on university campuses and in digs. There have already been successful pilots at Durham and De Montfort, using a variety of testing techniques and formats. Some tests have been done using telemedicine, some using traditional clipboard and picnic table techniques. There is further testing piloting to be done, but the indications are that this is proving an extremely successful model. It means that students can look forward to returning home for Christmas, confident that those who have the disease have been screened, and families can look forward to seeing students safely again.

On the testing of NHS workers, I agree with the noble Baroness that it is a priority. We are moving quickly on this. The purchase of tens of millions of lateral flow tests is a complete game-changer, and we remain committed to providing testing for the 1.3 million NHS workers. We aim to use lateral flow tests for some of these tests. NHS workers are themselves clinically trained, and it is appropriate for them to be able to use these tests. Therefore, we believe we can change the course of staff testing in the NHS environment using the new technology and a new approach to testing. I am extremely grateful to NHS colleagues for their participation in this important initiative.

Turning to DPHs, the noble Baroness is right that this is an important breakthrough. Again, the rollout of the lateral flow tests is important in that. She asked me about care homes, and she could have equally asked me about schools. I can deliver the same message on both: we have been sensitive to the appeals by DPHs for autonomy—for them to be able to make their own decisions, use their local intelligence and use their insight. That is why we have been reluctant to give any firm guidance on how they could or should use those tests. It is entirely up to DPHs to use the tests in the way they choose. But it is our expectation that some of those tests will be used in care homes, though there are other provisions for care home testing, and some will be used in schools, as well as for outbreak management and community testing.

The period for isolation is a subject under constant and rolling review by the CMO’s office and the policy team at DPH. I wish I could provide some kind of breakthrough—that the virus had in some way changed and was no longer infectious in people after a week or eight or nine days—but I am afraid I cannot provide that information. The frustrating thing about this virus is that it sits in the back of the throat or nose and remains infectious for an unfeasibly long time. That is why we are cautious about making dramatic changes in the isolation protocols.

What rapid testing provides is the opportunity to do frequent testing. The noble Baroness asked me about seven-day PCR tests; more likely and efficacious would be regular testing, every day or every other day, using the lateral flow tests, to do some form of test and release. We believe that avenue is more likely, and the CMO’s office is looking closely at that. It is entirely up to that office to make announcements on that score.

On adult social care, I reassure the noble Baroness that adult and child social care colleagues are fully involved in the preparations for a vaccine. She is right that social care provides its own set of challenges for the administration of the vaccine, but those are exactly the people we need to target with the vaccine. That is why they, particularly the elderly, are at the highest level of the JCVI’s prioritisation list. We are putting all our efforts into making sure that the vaccine delivery works for them.

The noble Baroness asked about ethnic minorities. May I put the question slightly differently? A number of difficult-to-reach groups have seen a high infection rate. It is a priority for us to make sure that the message on the vaccine breaks through any cultural, linguistic, demographic or other social barriers to get through to those groups who need it. They are not groups defined by race or the colour of their skin but by their proximity or otherwise to the normal course of government. We have learned through Covid that these groups are incredibly important from a public health point of view. From a values point of view, we owe it to them to do our best to reach them and we are putting the resources in place to do that. As for children, we have no current plans to vaccinate them. In terms of international partners, we are very focused on ensuring that all the intellectual property and manufacturing resources that we can possibly effect are put to work to get the vaccine into the arms of those around the world.

On cold storage, I reassure the noble Baroness that we have been on this for months. We have been aware of the demanding storage need of the Pfizer vaccine for a substantial amount of time and cold storage arrangements have been put in place. It is not necessary for that cold storage to be literally at the end of every street because the travel time for the vaccine is reasonably flexible. We have in place exactly what we need, not only for the Pfizer vaccine but for the Oxford vaccine and the others in the pipeline. JVT and Dr June Raine at the MHRA were crystal clear when they said that safety will not be compromised. I endorse their comments.

I will say a few words about our approach to managing messages to those who might feel anxious about the vaccine. This is not a moment for rebuttal or for attacking those who have questions about the vaccine, whatever those questions are and however far-fetched they might be. Our approach is to take all questions at face value, tackle them sincerely and approach them in an open-hearted way. By being defensive we play into the hands of those who have bad intentions, and by being aggressive we only amplify those causing trouble. Instead, we want to have an open dialogue with those who have concerns to emphasise the safety of the vaccine and, more generally, the normality of taking vaccines. It is with that kind of approach that we hope to deal with those who have concerns about taking vaccines.

The noble Baroness, Lady Jolly, asked a number of questions about the app. I cannot give her precise numbers on absolutely everything she asked but I can reassure her on a couple of things. There have been 20 million downloads, not 10 million. Take-up of the app has been enormous and, week on week, we see a huge number of check-ins on the venue-based element of the app, which is a huge part of its effectiveness. It helps us enormously with contact tracing. As for Bluetooth and the battery, I am disappointed to hear that the noble Baroness has had trouble with her phone. On the whole, that is not the feedback we have had from users and the recent update has emphasised the low-energy aspects of the Bluetooth protocol that the app uses. We think it will improve the performance of the app and lessen its drain on the battery.

The noble Baroness asked about tests; I will answer broadly. The innovation that we have seen in diagnostics for Covid has been incredible. It has included far-fetched—to me at least—technologies such as mass spectrometry. Some innovations have used the plastic lateral flows, which, although low-tech in their appearance, use extremely advanced technologies and chemicals to achieve accuracy, speed and cost performance. Some, such as LAMP, have taken old technologies and repurposed them for a new use. It has been extremely exciting to see. It is my aspiration that we will see an inflection point in diagnostics in the UK. This will aid an overall strategic step towards early intervention and put diagnostics at the heart of our medical science. It has already played an important part for a long time, but this will put it centre stage. I pay tribute to the work of Professor Mike Richards, whose review of the future vision for diagnostics in the NHS provides us with a target to aim for as we expand and invest in our diagnostics around Covid.

[The Deputy Speaker (Baroness McIntosh of Hudnall) (Lab)]

My Lords, we come to the 30 minutes allocated to Back-Bench questions. I ask that questions and answers be brief so that I can call the maximum number of speakers.

[Lord Patel (CB) [V]]

My Lords, the Minister referred to several areas where the lateral flow test will be deployed. The early reports from Liverpool’s mass screening using the test suggests that it performs well, with higher specificity and sensitivity, meaning that there is a negligible number of false positives and false negatives. That being so—and accepting that the vaccine will change the whole scene when it is available—apart from the areas that he has already mentioned, can he confirm what I have just said and give us the latest figures from Liverpool? Can he go on to say what plans the Government are making for the deployment of this test in other public areas to open up the economy?

[Lord Bethell (Con)]

I thank the noble Lord for his characteristically detailed and forensic question. The lateral flow test, as I am sure he knows, has the terrific advantage of giving very few false positives, but we do not pretend that it gives a clinical-level analysis of all the negatives. We therefore do not use it in a clinical setting as a symptomatic test; we use it as a screening test for asymptomatic cases. That is why it has been so valuable in a mass testing environment such as Liverpool. We can back up the tests of those who are positive with a double test, either with another lateral flow test or with a PCR test, to ensure that we do not create a problem with too many false positives. We are working on the protocols now to figure out exactly what kind of rate of second testing we need to get a fair analysis.

The noble Lord is entirely right that the vaccine will be a game-changer, but not everyone will take it immediately and we are not sure how long each vaccine will last for, so there will be a role for testing even after the vaccine has been deployed. In the meantime, testing is very much focused on social care, clinical workers, schools and universities. Those are the four areas where we are focused at the moment, but we hope it can be used further to enable the opening of the economy, as he alluded to.

[Baroness Noakes (Con) [V]]

My Lords, there have been estimates that hospital-acquired Covid infections are as high as one-quarter of all hospitalised Covid patients, which seems pretty shameful and is likely to be a major contributor to the Covid death statistics. What do the Government currently estimate the impact of hospital-acquired Covid infections to be, and what action are they taking to deal with it?

[Lord Bethell (Con)]

My noble friend is entirely right; in any epidemic, nosocomial infection is one of the greatest challenges faced. If you want to find a recent infection of Covid, the best place to find it is where there is someone already with the disease, because that is the way that epidemics work. Hospitals necessarily have a high concentration of those with the disease. It is true that during the early months of the epidemic, when there were challenges with PPE and when practices within hospitals were not as disciplined as we would have liked, nosocomial infection, as it often is in epidemics around the world and throughout history, was a big challenge in hospital care and social care. That has been extremely well documented. However, I pay tribute to colleagues in the NHS who have come a very long way in the administration of PPE, confinement practices and infection control. The nosocomial infection that we are seeing is at dramatically lower rates than it was in the past, and that is due to the hard work and science of those in the healthcare sector.

[Lord Wills (Lab) [V]]

The Minister will be aware that during the first lockdown the utilisation of beds in the private sector, under its partnership agreement with the NHS, was 20%. What reassurance can the Minister give that there will not be a similar underutilisation of capacity for testing in the independent sector in the weeks and months ahead?

[Lord Bethell (Con)]

My Lords, I am not sure that I entirely understood the question. In terms of the private beds that we intended to use, that capacity was extremely valuable as a fallback during the first wave, but I am pleased to say that it was not needed. There is some testing in the private sector, but we are not leaning on that at the moment. The testing that is done by the Government is through test and trace, and we are committed to using as much of that capacity as is needed.

[Lord Scriven (LD) [V]]

The Statement says nothing about antibody testing. On 6 October, the noble Lord announced the £75 million single-source purchase of antibody test kits from Abingdon Health. Official correspondence, dated 1 October, reveals that the department had a report by Public Health England that shows that those antibody tests were not accurate enough for their intended use and that the department would delay publication of the report until after the Government announced that they had purchased them. Why was that, Minister?

[Lord Bethell (Con)]

If the noble Lord would not mind, could he repeat the question, because I could not hear the words, I am afraid?

[Lord Scriven (LD) [V]]

The Statement says nothing about antibody testing. On 6 October, the noble Lord announced the £75 million single-source purchase of antibody test kits from Abingdon Health. Official correspondence, dated 1 October, reveals that the department had a report by Public Health England that shows that those antibody tests were not accurate enough for their intended use and that the department would delay publication of the report until after the Government had announced that they had been purchased. Why was that, Minister?

[Lord Bethell (Con)]

I am afraid I am not familiar with the report to which the noble Lord refers. I am glad to undertake to write with an answer to that question.

[Lord Loomba (CB) [V]]

My Lords, it is very good news that there is now a potential vaccine that shows prospects of good efficacy. The Health Minister showed MPs in the other place that mass rollout of the vaccine would be ready to start from as early as the beginning of December, and we have placed an order for 40 million jabs. Given that the vaccine is still not approved as 100% safe or approved by the authorities, can the Minister give more information on the reality of how long it is likely to be before a safe rollout takes place?

[Lord Bethell (Con)]

My Lords, I am afraid I cannot offer a firm schedule or confirmed dates for the rollout because they depend on the independent judgment of the MHRA, the CMO and the JCVI. These important decisions are out of our grasp, but it is clear that the progress made by Pfizer, AstraZeneca and other companies in the vaccine’s pipeline has been dramatically quicker than had initially been expected. We are making preparations to have the NHS ready for the beginning of December in case a vaccine is available by then.

[Lord Clark of Windermere (Lab) [V]]

My Lords, this just highlighted the key role of GPs in any vaccine rollout, but in parts of the country there is a dire shortage of GPs with, on occasion, surgeries being run by nurse practitioners and other specialist nurses to great effect. Will the Minister check that, in the absence of GPs, nurse practitioners will have, first, full authority to activate any initial planning; secondly, empowerment to undertake the necessary continuing administration for the vaccination rollout; and thirdly, current authorisation to prescribe and vaccinate applicable in any national rollout?

[Lord Bethell (Con)]

I thank the noble Lord for his championing of nurse practitioners, because we are going to rely on all qualified healthcare workers to administer an injection to support this huge project—one of the largest of its kind in recent national history. I also emphasise the role of pharmacists who will, where appropriate, deliver the vaccine as well. We need a massive, mass-scale effort to deliver this vaccine. We will be empowering all those qualified to deliver the injection to do so and we are extremely grateful to them, including nurse practitioners, for their help in this matter.

[Lord Jones of Cheltenham (LD) [V]]

My Lords, President-elect Biden has shown refreshing leadership by setting up a panel of scientific experts to deal with Covid-19. Why, then, do the Government think that a venture capitalist married to a government Minister is best placed to chair the Vaccine Taskforce rather than an expert in vaccines?

[Lord Bethell (Con)]

The role of Kate Bingham, the head of the Vaccine Taskforce, has been to acquire vaccines—and that is what she has done. She has served the nation brilliantly by acquiring six of the vaccines on four of the platforms. We should be extremely grateful for the work that she has done. It was not remunerated, and it was extremely effective. To knock those who have contributed voluntarily to our fight against Covid is not appropriate at this stage.

[Viscount Waverley (CB) [V]]

My Lords, notwithstanding the Minister’s positive and sensitive remarks this evening, can it be confirmed that, despite SAGE advice and planning, a national mass Covid testing programme has been ruled out by No. 10 this week? If that is the case, who mandated the decision and what was the rationale for doing so?

--- Later in debate ---

[Lord Bethell (Con)]

The noble Viscount is better advised than me. As far as I understand, mass testing remains a central part of our battle against Covid and we remain committed to that programme.

[Lord Moynihan (Con)]

My Lords, there is growing concern that the unique Pfizer vaccine, with an mRNA genetic molecule that cellular machinery reads in order to build proteins, could be incompatible with the World Anti-Doping Code for all sports men and women, including Premier League footballers and Olympic athletes. Since the World Anti-Doping Agency already bans the use of agents designed to impact genome sequences if they have the potential to enhance sport performance or provide unfair advantage, and pursuant to my noble friend’s very helpful answer yesterday, will the Government undertake to work with the World Anti-Doping Agency and offer comprehensive advice to the sporting world before any vaccine programme begins?

[Lord Bethell (Con)]

I am extremely grateful to my noble friend for flagging up this important concern, which I acknowledge is a serious worry for those in the athletic and sporting arena. Colleagues at DCMS are aware of this concern. It is extremely early days and we do not know what the impact of the vaccine will be on the kind of protocols analysed by the World Anti-Doping Agency, but we have sought advice from the WPA on this matter and I will be happy to convey it as soon as it arrives.

[Lord Liddle (Lab) [V]]

My Lords, this week’s news about the vaccine has been a great uplift at a very grim time. However, rolling it out will prove a massive logistical challenge, as I think the Minister accepts, at the same time as we are trying to repair the gaps and strengthen our test and trace systems, and trying not to damage the rest of the services provided by the NHS. Does this not all require a massive upscaling of the command and control capabilities of the Government? What steps are they planning to put in place to manage this phase of the crisis more successfully than they have managed it so far?

[Lord Bethell (Con)]

My Lords, I share the noble Lord’s sentiment that the vaccine is an uplift and a source of optimism, but I hope that he will not mind if I also use this opportunity to say that the British public—all of us—must stick with the protocols that are in place at the moment. It is not early enough for us to depart from social distancing and the current regulations around the lockdown. However, his point is extremely well made. We are determined to use the respite of the current lockdown to fill the gaps, to improve performance where it is needed, to address acknowledged weaknesses in test and trace, particularly in the tracing area, and to improve our performance thoroughly. However, I do not necessarily acknowledge the need for an upscale in the command and control elements. Certainly for the administration of the vaccine, we will be working through the existing NHS infrastructure, putting GPs’ surgeries and pharmacies at the centre of delivery. Test and trace is run through existing ministerial structures, with accountability to Parliament, and we intend to keep it that way.

[Lord Greaves (LD)]

My Lords, the Statement is very positive about the quickie lateral flow tests. It refers to the pilots in Stoke-on-Trent and Liverpool and the fact that mass testing will be carried out in 67 other authorities. However, the list does not appear to include Lancashire, which I thought was part of that testing. Can the Minister confirm that Lancashire is part of it, even though it has been missed off the list, and is it the whole of Lancashire or just some of the 12 districts in Lancashire? The Statement also refers to the Government’s strategy of suppressing the virus and supporting education, the economy and the NHS until a vaccine is available. That is fine but, once again, it does not home in on the people who are really suffering—close family and friends, and particularly old and vulnerable people. A recent report—released this week, I think—from the Red Cross, called Lonely and Left Behind, really shows up the misery and mental disarray that a lot of these people are in. Some have been locking themselves down and have been frightened to go out since the early spring. Does the Minister understand that, if a system of quickie testing of this kind and then vaccination are to be brought in, these people have to be treated as an absolute top priority, and that the first thing the Government have to do is to give them the confidence to take part in it?

[Lord Bethell (Con)]

My Lords, I reassure the noble Lord that the 67 DPHs who are taking the tests in the first round are those who stepped forward. I believe that they include DPHs in Lancashire, but I shall be happy to confirm that. Regarding the Lonely and Left Behind report, the noble Lord put it extremely well. Of course those are the people who have been extremely hard hit by the pandemic. I hope he will acknowledge that we have put those who are older and vulnerable at the top of the prioritisation list—there has been no ambiguity about that. They will be vaccinated first and will therefore be freed from lockdown. When the vaccination is available, it will be a massive priority to get our society open again and to get the love, tenderness and support to the people whom he described—all things that are needed in order for them to have happy and fulfilled lives.

[Lord Forsyth of Drumlean (Con) [V]]

My Lords, why has my noble friend not answered my Written Questions on the following: on false-positive tests, which were due on 28 September; on the legality of using the Public Health Act for lockdown, which was due on 14 October; and, finally, on why those Questions have not been answered, which is also overdue?

[Lord Bethell (Con)]

I can only apologise to my noble friend for the slowness in replying to his Questions. It is not a reasonable excuse, but the Department of Health and Social Care has been overwhelmed by the pandemic. A large amount of our correspondence is behind schedule. I have worked hard to try to catch up on that, but I apologise to him sincerely for the delay. When I get back to the department tomorrow morning, I will chase it up and get him replies to his perfectly reasonable Questions.

[Lord Rooker (Lab) [V]]

In the fourth paragraph of the Statement, the Secretary of State boasts that over 10 million people were tested at least once through NHS Test and Trace. The figure for the latest week, published by the Minister’s department today, is 10,800,031—a rise of 613,000 last week, or 87,600 a day. The week before, it was 88,200 a day, and the week before that it was 95,153 a day. Why are we going backwards in testing people at least once through NHS Test and Trace?

[Lord Bethell (Con)]

My Lords, the capacity that we have in track and trace is growing dramatically; the number of tests we have taken is going up. It is true that testing demand does fluctuate. There was a moment when universities had a very large outbreak and there was a huge amount of demand from universities, and there may well be other reasons why testing demand goes up in the future. But I reassure the noble Lord that the capacity, speed and accuracy of testing in this country are making huge progress on a day-by-day basis, and I pay tribute to those involved in the project.

[Lord Willis of Knaresborough (LD) [V]]

My Lords, a key factor in controlling Covid-19, with or without a vaccine, is test, trace and isolation, and I fully support that. Yet the recent survey indicated that some 20% of those asked to isolate actually failed to do so, rendering the system far less effective than it should be. What is the reasoning behind the reluctance of the Government to move from PCR to lateral flow testing for the test and trace programme, following the extensive clinical evaluations by PHE and Oxford University, which found 99.6% accuracy, including on the key criterion for track and trace of detecting asymptomatic carriers? Surely, accurate 48-hour testing would enable virus-free contacts to return to normal activity quickly, rather than sitting at home for 14 days.

[Lord Bethell (Con)]

My Lords, the noble Lord is entirely right on two things, and wrong on another. He is entirely right that isolation is absolutely key—without isolation, there is no point in testing or tracing. It is true that not everyone who is asked to isolate does isolate, but we have a programme in place to try to encourage, inform and inspire people to isolate. He is entirely right that lateral flow tests offer huge advantages, in terms of the speed at which they can be used, their cost and their flexibility. But we have bought tens of millions, maybe even hundreds of millions, of these tests in recent weeks. We are deploying them in mass testing, and we have completely followed the advice and inspiration of the noble Lord in this matter in a massive way.

[Lord Bilimoria (CB) [V]]

My Lords, Sir John Bell, the Regius Professor of Medicine at Oxford University, has said that these inexpensive, easy-to-use lateral flow antigen tests, when used systematically, could reduce transmission by 90%. Could the Minister confirm that the trials are already showing that these tests are picking up 75% of positive cases and 95% in the most infectious individuals? If that is the case, when can we have these millions of tests that Ministers have spoken about deployed, not only in the NHS, care homes, schools and universities but at airports, factories, offices, workplaces, theatres and even sports grounds, so that we can get our economy back firing on all cylinders very soon?

--- Later in debate ---

[Lord Bethell (Con)]

As ever, I am inspired by the noble Lord’s passion for this subject. He has totally won the argument in this matter, because we are putting into the field millions of tests, as he recommended and continues to champion. The pilot in Liverpool is extremely exciting, and the tests themselves are proving both easy to administer and accurate in their diagnosis. We are working on ways of using these tests in a mass testing capacity. Universities and social care are two user cases that we have prioritised, and we are looking at using the lessons of Liverpool in other areas. In all matters, we continue to be inspired by the noble Lord.

[Baroness Pidding (Con) [V]]

My Lords, I join with others in welcoming the news regarding a possible vaccine and shall look forward to hearing more in the coming weeks. At last, we have some light at the end of a very dark tunnel. With lockdown 2 expiring on 2 December, it is critical that businesses are able to make plans now for post the release date, especially with Christmas looming so close. Can my noble friend the Minister give an indication as to what the plans are for after this date? We understand that tiers will be reintroduced. Will those tiers stick to the same measures we had before in each tier? How will different tiering be determined and, most importantly, at what point will businesses be advised?

[Lord Bethell (Con)]

My noble friend is right that the advice to business is extremely important, and we are ambitious to try to unlock the economy to enable people to return to as normal a life as they possibly can and to prepare the country for Christmas. However, it is too early to tell exactly what the state of the pandemic will be on 2 December. There is a review of the tiering system, and we will learn the lessons of the last round. The Prime Minister has made it very clear that he is committed to returning to a regional tiering system, but the exact dimensions and specifications of that system are under review, and communication to business of how, and to which regions, it will apply will be forthcoming once the analysis of the contagion has been completed.

[Lord Hunt of Kings Heath (Lab) [V]]

I declare my interest as a member of the GMC board. I return to the Statement made by the Secretary of State, in which he said, referring to NHS staff:

“The deployment of the vaccine will involve working long days and weekends, and that comes on top of all the NHS has already done”.—[Official Report, Commons, 10/11/20; cols. 746.]


The noble Lord will be aware that the GMC granted temporary registration to around 27,000 doctors in order to help out with the pandemic crisis. My question is: has the department considered using these doctors, not many of whom have actually been used by the NHS so far, for the vaccine programme? Will he look into that?

[Lord Bethell (Con)]

My Lords, the noble Lord raises a very good point. We pay tribute to all those who stepped forward, whether they were young doctors at the end of their training or older doctors who were returning to the profession. It was a really important and touching moment when those doctors stepped forward. He is right that not all of them were needed or used during the pandemic. My understanding, from the deployment team, is that they are looking at all avenues to have the largest army of people possible in order to use the vaccine. I am not exactly sure of the exact status of the 27,000 doctors he alluded to, but I would be glad to write to him with details.

[Lord Robathan (Con) [V]]

My Lords, according to local media, on Tuesday the city of Leicester—I live in Leicestershire—recorded the highest number of infections since the beginning of the pandemic. Leicester has been locked down since June, so could my noble friend confirm that this is the case, and, if it is, could he say whether this has happened because we do not know very much about the virus, whether it is the case that lockdowns do not work—as some people say—or is he going to blame the good people of Leicester for not abiding by the regulations?

[Lord Bethell (Con)]

I greatly thank the people of Leicester for their patience with the lockdown and with the very large number of measures that have been put in place there. The noble Lord is aware that some communities live and work very close to each other, and the transmission of the disease is affected by a very large number of factors. I cannot explain to him exactly why the infection rates are so high in Leicester today, but I absolutely applaud all those who have been working hard in that city to keep the epidemic at bay.

[Lord Mackenzie of Framwellgate (Non-Afl) [V]]

My Lords, following on from the last question, recent evidence shows that the north of England has been affected hardest by Covid-19 in terms of infections and deaths, caused mainly in hospitality settings. Compliant citizens are upset by the minority who flout the law. When the lockdown ends on 2 December, restrictions such as wearing masks and distancing will be only as effective as the public’s compliance. As the police cannot be in every pub, shop or restaurant, is it not time for the enforcement of such measures to be done by the venue itself, with the ultimate sanction of immediate closure by the police or local authority for wilful non-compliance?

[Lord Bethell (Con)]

The noble Lord is completely reasonable in his concerns but that is not the approach we are taking at the moment. Actually, public support for the lockdown measures—the wearing of masks, social distancing and restrictions on travel—has been amazing. Lockdown has been largely by consent and extremely well supported by the public in their behaviour. We are extremely proud that in Britain we do not need the Army on the street with their guns or the police fining people on the street, as they do in other countries. I pay tribute to the British public for the way in which they have gone along with those measures. The noble Lord makes the point that some people have been in breach of the rules and there have been prosecutions and fines. However, they have been minimal and have had their effect. We will continue to operate at the kind of level at which we have been operating to date.

[Baroness McIntosh of Pickering (Con)]

My Lords, my noble friend will be aware of my interest in the Dispensing Doctors’ Association. Will he update the House on where we are with the vaccination programme for the over-50s? What use will be made of dispensing doctors in rural areas to dispense the Covid-19 vaccine? I hope he will rely on them fully because they have the network to provide it in much the same way as the noble Lord, Clark, explained.

[Lord Bethell (Con)]

My noble friend will be aware of the prioritisation list published by the JVCI. I am afraid that the over-50s, of which I am a member, are not highest on the list, but they are at least halfway down. Prioritisation starts with the over-80s and works down from there. I completely endorse my noble friend’s comments on dispensing doctors. We will be relying on all parts of the healthcare ecology to deliver the vaccine. It will be a massive national project. Getting to hard-to-reach rural communities is incredibly important, particularly people in those communities who are older and perhaps do not travel. Dispensing doctors pay a pivotal role in that, and I pay tribute to their contribution to the vaccine.

[The Deputy Speaker (Baroness McIntosh of Hudnall) (Lab)]

My Lords, the time allotted for Back-Bench questions has now elapsed.

Covid-19: Vaccine

Lord Bethell Excerpts

Wednesday 11th November 2020 Lords Chamber

[Baroness Jolly]

To ask Her Majesty's Government, following the recent analysis of the effectiveness of the Pfizer and BioNTech Covid-19 vaccine, what arrangements they have put in place to distribute approved Covid-19 vaccines (1) in the United Kingdom, and (2) internationally; and who determines the protocol for priority of access to any such vaccines.

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

My Lords, the NHS is preparing to be ready to deploy a Covid-19 vaccine as soon as one is safe and effective. Distribution arrangements remain flexible and include the make-up of the workforce needed to rapidly deliver a vaccination programme, training requirements, consumables and supporting infrastructure. The UK continues to work through multilaterals, such as the G7 and the G20, and with the WHO to agree collaborative approaches to supporting global vaccine development and distribution.

[Baroness Jolly (LD) [V]]

The Government anticipate that the vaccination programme will start with the most vulnerable and those living and working in care homes. Vaccination into muscle does not need to be administered by a clinician; any of us could be trained to do it. Which organisations are the Government working with to make this happen? Can the Minister confirm that there will be no need to take out contracts with the private sector, but that the Government will use the military, local resources—such as public health, fire and ambulance services—and trained volunteers?

[Lord Bethell (Con)]

My Lords, the noble Baroness is entirely right that the range of people who can administer this vaccine is extremely wide. The challenge of administering so many vaccines in such a short amount of time will indeed require the involvement of a large range of people. We are putting in the recruitment and training necessary for that to happen. I am particularly grateful to all healthcare workers, particularly those from professions such as the pharmacy industry, who are stepping forward to meet this challenge. We are not allergic, though, to using the private sector in this matter, and we will be explaining the detailed terms of our arrangements at a later date.

[Lord Campbell-Savours (Lab) [V]]

I plead with the Minister to ensure that whatever arrangements are being made for rapid result testing and vaccination, absolute priority is given to the vulnerable, itinerant, homeless and occupants of night shelters, for the earliest possible access to testing, when the new rapid testing regime is introduced, and for vaccination. They are very vulnerable people, and that is the least we can do for those in need.

[Lord Bethell (Con)]

The noble Lord makes a persuasive case for those who are most vulnerable, including the itinerant and the homeless. We have seen for ourselves the impact of the disease on those who live in close quarters with each other, have health vulnerabilities or are exposed to the disease due to the nature of their circumstances. Those who are most vulnerable should surely be at the top of the list. I do not know the precise arrangements for the homeless and itinerant, but he makes an extremely good point, and I would be glad to get back to him with details.

[Baroness Barker (LD)]

My Lords, as is the case with the ordering of home testing kits, in order to prove one’s identity and access the vaccine, will UK citizens be required to share their credit rating history with US data-mining companies with which the Government have signed contracts?

[Lord Bethell (Con)]

No, they will not.

[Lord Mackay of Clashfern (Con) [V]]

My Lords, what are the arrangements in Scotland as far as the Minister knows?

[Lord Bethell (Con)]

My Lords, we are taking a four nations approach to the deployment of the vaccine. The Scottish NHS has been involved in all the arrangements we have been putting together and in both the Vaccine Taskforce, to procure the vaccines, and the Joint Committee on Vaccination and Immunisation, which has been discussing prioritisation. Furthermore, it has a voice at the DHSC, which is responsible for deployment.

[Lord Patel (CB) [V]]

My Lords, the announcement of the effectiveness of the Pfizer BioNTech vaccine being not only the first vaccine against Covid-19 but the world’s first vaccine against infection developed using messenger RNA is a huge scientific advance. There are challenges in delivering an effective national vaccination programme. As Professor Melinda Mills, in a report from the Royal Society and British Academy, pointed out, not the least is honest, transparent public communication free from hyperbole. Does the Minister agree? If so, who does he think would be best placed to lead the public communication of the programme?

[Lord Bethell (Con)]

The noble Lord is entirely right that we have to approach the prospect of a vaccine in a measured way. There remain considerable imponderables about the effectiveness, longevity, impact and side-effects of a vaccine. These are things that we do not know yet, and we have to keep our eyes open to the limits of what the vaccine may or may not be able to do. That said, the initial data from Pfizer is incredibly encouraging. We have taken a measured approach in our communications to date. Jonathan Van-Tam, the Deputy Chief Medical Officer, is the face of the vaccine, as it were; he is the member of the Vaccine Taskforce who has brought the clinical perspective to its work, and he will remain an important voice in all this.

[Baroness Thornton (Lab)]

It is good news indeed. I would like the Minister to share how the Government are preparing to build public confidence in the vaccine and counter the anti-vax campaigns. Following my noble friend’s question earlier, I would be grateful if the Minister could share with the House the plans for reaching harder-to-reach communities, so they can get the information they need and access to the vaccine when the rollout starts.

[Lord Bethell (Con)]

The noble Baroness is right that we face a challenge. While there will be millions of people who will come forward emphatically to have the vaccine, there will be some who are either disengaged with the British Government or actively hostile to the thought of a vaccine, and we take seriously the disruption caused by those who seek to profit either financially or politically from the confusion and distress caused by anti-vax campaigns. It is not appropriate for me to discuss at the Dispatch Box the detailed measures we are putting in place to deal with the anti-vax message, but I can reassure the noble Baroness that they are focused, energetic and proving to be effective.

We also take seriously our efforts to reach hard-to-reach communities—those who might not have confidence in the Government or we might not have the right connection with. Those communities are exactly the ones we need to vaccinate, and we are making them an enormous priority in our efforts.

[Lord Moynihan (Con)]

Will my noble friend the Minister ensure that among the priority groups for vaccination will be the sportsmen, sportswomen and their entourages who are seeking to represent GB in international events during 2021, in particular the Olympic and Paralympic athletes who aim to qualify for and participate in the Olympic Games in Tokyo? Will the Government urgently consult with the World Anti-Doping Agency to ensure that all approved vaccines are exempt from any possible breach of the current regulations on doping?

[Lord Bethell (Con)]

I am grateful to my noble friend for that question, which is incredibly important because we all take our preparation for the Olympics extremely seriously. I am also grateful to him for giving me advance notice of it. There is a desire for all the UK population to be vaccinated, including those who represent the UK. Prioritisation decisions will be based on vaccine availability and scientific clinical evidence on the safety and efficacy within different population groups. The JVCI is the independent expert on this and will make the decision he refers to. The World Anti-Doping Agency is actively responding to the coronavirus outbreak as it relates to the global anti-doping programme and the regulations are evolving rapidly.

[Lord McCrea of Magherafelt and Cookstown (DUP) [V]]

Acknowledging the possibility of a vaccine being made available before Christmas, can the Minister assure me that a Northern Ireland supply is part of the UK’s order, and will the Northern Ireland Executive be involved in discussions over its distribution? Can the Minister also tell us when he expects news concerning the vaccine being developed by Oxford University?

[Lord Bethell (Con)]

We are working extremely closely with the Northern Ireland Administration to ensure deployment of the vaccine; as I said earlier, this will be done on a four-nations approach. The Oxford vaccine is going through the final stages of phase 3. We are very much looking forward to hearing how it is going but I am afraid to say that I do not have a precise date for when that will be.

[Lord Scriven (LD) [V]]

My Lords, what specific arrangements have the Government put in place at our borders to ensure that the vaccine can pass speedily, without hindrance, from Belgium after 31 December?

[Lord Bethell (Con)]

My Lords, we have extremely detailed and thorough arrangements for our borders on 31 December. No problems are envisaged with regard to the vaccine.

[Lord Balfe (Con)]

My Lords, I draw attention to the bit of the Question that says:

“distribute approved coronavirus vaccines in the UK and internationally”.

There is a great danger in the international distribution that corruption will creep into the system. Can the Minister assure me that the Government will co-ordinate with the EU and like-minded international aid agencies to ensure that corruption is avoided and the vaccine that we donate is delivered for free to vulnerable groups in countries overseas?

[Lord Bethell (Con)]

My noble friend makes a very reasonable point. The marketplace for vaccines is extremely competitive. The British Government have been emphatic in our commitment to CEPI, Gavi and the other vaccine organisations. The COVAX advance market commitment aims to produce 1 billion doses for high-risk populations in 92 developing countries in 2021. We support that initiative enormously and work with other partners to ensure the fair and equitable distribution of vaccines around the world.

[Lord Bilimoria (CB) [V]]

[Inaudible]—about the Pfizer BioNTech vaccine and full credit to the vaccine taskforce. Given that other vaccines, such as the Oxford AstraZeneca one, will, I hope, be available soon, what will the Government do to ensure the rapid rollout of the inoculations of these vaccines? Can business help in any way? As president of the CBI, we stand by to help in any way we can. Secondly, I offer my congratulations on the rapid mass-testing pilot starting in Liverpool. Can the Minister confirm that these pilots will now be rolled out to another 67 regions, and how soon will that happen?

[Lord Bethell (Con)]

I am grateful for the noble Lord’s remarks. Business can play an important role. Distribution of the vaccine will employ a large workforce and the supply chain is incredibly important. There will be a dimension for business to provide thought leadership and behavioural leadership to encourage and make space for employees and to be advocates for the principle of vaccination in every way. In terms of mass testing, we have sent lateral flow devices to 67 directors of public health and we will be learning from the Liverpool experiment to see whether we can apply citywide mass testing of the kind he describes to other cities in the future.

[Lord Lancaster of Kimbolton (Con)]

My Lords, I commend the Government on the leadership they have shown in committing £548 million to the COVAX advance market commitment to which my noble friend referred a few moments ago. That is essential if we are to ensure that poorer countries are to get access to these vaccines. However, with some $2 billion of seed corn funding required by the end of this year, what are the Government doing to ensure that other first-world countries follow our lead in this area?

[Lord Bethell (Con)]

I am grateful to my noble friend for the question on international vaccines. He is right that no single country holds the keys to victory against this invisible enemy and we must work together. I point out in particular the work of the ACT Accelerator, which estimates that $38 billion is needed by the end of next year for equitable access to vaccines. This will be an important part of our chairmanship of the G7, which starts at the beginning of next year, and which will be a helpful platform for Britain’s advocacy of fair and equitable distribution of vaccines.

[Lord Flight (Con) [V]]

I thank all involved for the achievement of a successful vaccine. What, if any, is the effect of the vaccine if taken when the recipient is already testing positive for coronavirus?

[Lord Bethell (Con)]

My Lords, my understanding at the moment is that it is not necessary to take a coronavirus test before having the vaccine. This has been one of the subjects of the trials that have taken place so far. I do not believe that there is any effect at all but I am happy to check that, seeing as it is a detailed clinical point that is beyond my personal experience, and revert to my noble friend with confirmation of it.

[The Deputy Speaker (Lord Brougham and Vaux) (Con)]

My Lords, all supplementary questions have been asked.

Medicines and Medical Devices Bill

Lord Bethell Excerpts

Committee stage & Committee: 5th sitting (Hansard) & Committee: 5th sitting (Hansard): House of Lords
Wednesday 11th November 2020 Grand Committee

Moved by

[Lord Bethell]

51: Clause 8, page 5, line 12, at end insert—
“(1A) The appropriate authority may only make regulations under subsection (1) if satisfied that they would promote one or more of the following—(a) the health and welfare of animals;(b) the health and safety of the public;(c) the protection of the environment.”Member’s explanatory statement
This amendment provides that the appropriate authority may only make regulations under subsection (1) of Clause 8 if satisfied that they would promote the health or welfare of animals, the health and safety of the public or the protection of the environment.

--- Later in debate ---

Moved by

[Lord Bethell]

54: Clause 8, page 5, line 13, leave out “making regulations under subsection (1)” and insert “considering whether they would”
Member’s explanatory statement
This amendment requires the appropriate authority to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 8 in considering whether regulations under subsection (1) would promote the health or welfare of animals, the health and safety of the public or the protection of the environment.

--- Later in debate ---

Moved by

[Lord Bethell]

56: Clause 8, page 5, line 15, leave out “in relation to animals, humans and the environment”
Member’s explanatory statement
This amendment is consequential on the amendment in the Minister’s name inserting a new subsection after subsection (1) of Clause 8.

--- Later in debate ---

Moved by

[Lord Bethell]

64: Clause 10, page 6, line 27, leave out from “regulations,” to end of line 28
Member’s explanatory statement
See the explanatory statement for the amendment in the Minister’s name inserting new subsection (1A) into Clause 10.

--- Later in debate ---

Moved by

[Lord Bethell]

66: After Clause 10, insert the following new Clause—
“Disclosure of information in accordance with international agreements
(1) This section applies to information which a relevant authority holds in connection with veterinary medicines.(2) The relevant authority may disclose information to a person outside the United Kingdom where required for the purpose of giving effect to an international agreement or arrangement concerning the regulation of veterinary medicines.(3) The relevant authority may not disclose commercially sensitive information in reliance on subsection (2) unless the relevant authority— (a) considers that it is necessary to do so for the purpose mentioned in that subsection, and(b) is satisfied that the making of the disclosure is proportionate to what is sought to be achieved by it.(4) Except as provided by subsection (5), the disclosure of information in accordance with this section does not breach—(a) an obligation of confidence owed by the person making the disclosure, or(b) any other restriction on the disclosure of the information (however imposed).(5) Nothing in this section authorises a disclosure of information which—(a) contravenes the data protection legislation (but in determining whether a disclosure would do so, take into account the powers conferred by this section), or(b) is prohibited by any of Parts 1 to 7 or Chapter 1 of Part 9 of the Investigatory Powers Act 2016.(6) In this section—“commercially sensitive information” means commercial information whose disclosure the relevant authority thinks might significantly harm the legitimate business interests of the undertaking to which it relates;“relevant authority” means—(a) the Secretary of State, or(b) the Department of Agriculture, Environment and Rural Affairs in Northern Ireland;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018.”Member’s explanatory statement
This new Clause makes clear that information held by the Secretary of State or the Department of Agriculture, Environment and Rural Affairs in Northern Ireland in connection with veterinary medicines can be disclosed, subject to certain restrictions, to persons outside the United Kingdom in order to give effect to a relevant international agreement or arrangement.

--- Later in debate ---

[Baroness Wheeler (Lab)]

My Lords, our Amendment 106, which I am speaking to on behalf of my noble friend Lady Thornton, is in this group on reporting requirements under the Bill. Specifically, it would add a new clause providing for an annual report to Parliament on medical devices information systems established by NHS Digital under the powers conferred by Clause 16. I am grateful to the noble Baroness, Lady Bennett, for her support for this amendment.

Clause 16(1) gives the Secretary of State the power by regulations to make provision for NHS Digital to establish and operate

“one or more information systems”

for medical devices. Under the Bill, these relate to the safety, performance and

“clinical effectiveness, of medical devices … placed on the market; … the safety of individuals who receive or are treated with a medical device”,

or who have one implanted in them, and

“the improvement of medical device safety and performance through advances in technology”.

The annual report proposed in our amendment would provide for the operation of these information systems to include information on the overall data in relation to

“the number of patients who receive or are treated with a medical device, or into whom a medical device is implanted; … any safety concerns received; and … any regulatory action taken.”

Finally, the amendment would ensure that the Secretary of State provided a copy of the report from the information centre on these related areas to the devolved Administrations in Scotland, Wales and Northern Ireland.

The Government’s own Amendment 131, providing a new clause after Clause 41 on consultation provisions and requirements, limits itself to the provision of a biennial report to Parliament starting:

“As soon as reasonably practicable after”


the Bill has passed on the operation of regulations laid on human medicines, veterinary devices and medical devices. The amendment is part of the Government’s response to the Delegated Powers and Regulatory Reform Committee. It also provides for regulations to be subject to public consultation before they can be made and requires the Secretary of State to include in the biennial report, as part of a consultation process, a summary of the concerns expressed or proposals put forward and, in consulting, to set out how the key issues of safety, availability and attractiveness have been taken into account.

The Minister’s letter to Peers of 13 October, which, as my noble friend Lady Thornton has already pointed out, we did not receive until after the amendments had been laid, underlines the importance of the Government’s amendments in providing a reporting obligation on the Secretary of State which

“will inform Parliament of the outcome of consultations on regulation made under Clauses 1, 8 and 12 during the two-year period under consideration, and provide a look ahead to expected regulatory change in the future”.

While consultation before the preparation of the report and information on the consultation, concerns and proposals are welcome, we do not accept that Amendment 131 fully meets the concerns of the DPRRC. We consider that an annual report to Parliament is essential, given the vital importance of the scrutiny and accountability that Parliament must be able to exercise.

We also consider that the government amendment should make a specific commitment to consultation with the devolved Administrations in Scotland, Wales and Northern Ireland, and not just to the Secretary of State consulting such persons as he/she considers appropriate. We will take up the key issue of consultation with the devolved Administrations in our later amendment and I look forward to the Minister’s response to the question of the noble Lord, Lord Patel, on these areas.

Finally, I strongly support Amendments 67A and 67B from the noble Baroness, Lady Jolly, which call for reviews to be laid before Parliament of the regulation of veterinary devices and the Bill’s impact on veterinary medicines after the Act is passed. The noble Baroness made a pretty convincing case for these amendments. The delegated powers in Part 2 of the Bill to amend the Veterinary Medicines Regulations 2013 are wide-ranging. Close scrutiny of the impact on animal welfare, human safety and the environment, together with full consultation with key stakeholders and recommendations on the need for further regulation, will be crucial. Similarly, the review of the Act’s impact on veterinary medicines, to be published one year after it is passed; on safety in relation to animals, humans and the environment; on availability in the UK; and on the UK’s participation in the development and supply of veterinary medicines would ensure full scrutiny of how the provisions in Clauses 9 and 10 were working in respect of these key issues.

I have two further points. During the Commons Committee on the Bill, we raised the importance of the availability of veterinary medicine services, as well as medicines across the country, and of ensuring that they are available in rural and urban settings. This would ensure that we do not have a two-tier system whereby there is better access to veterinary medicines and services in certain communities. We also called for a full assessment of the capacity of the veterinary industry to meet the regulatory and other requirements set out in the Bill. These are key issues which the review process set out in the amendments of the noble Baroness, Lady Jolly, would address. Can the Minister tell the Committee what work is being undertaken with veterinary sector stake- holders, including the British Veterinary Association and the Royal College of Veterinary Surgeons, on these issues —particularly to ensure that, post Brexit, we have the sustainable, diverse and modernised UK veterinary infrastructure and skilled workforce that we need to ensure a safe environment for humans and animals?

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

My Lords, Amendment 67A, put forward by the noble Baroness, Lady Jolly, relates to veterinary devices. This is a proposed new clause seeking to ensure that the Secretary of State sets up a working group to review the regulation of veterinary devices within six months of this Act passing.

There is currently no specific legislation for veterinary medical devices. The market is small and manufacturers may choose to market their products for dual use—for humans and animals. The medical devices regulations are intended only for human devices. However, we consider that the regulatory framework is also suitable for ensuring the quality and safety of equipment for veterinary use. The Bill allows us only to amend or supplement the existing veterinary regulations in the manner described in Clauses 9 and 10. Those clauses do not provide authority for regulations to introduce substantial new standalone requirements for veterinary medical devices. If a medical device is packaged with a veterinary medicine, the marketing authorisation application would need to set out relevant information on that device. The device would therefore be assessed together with the veterinary medicine before a marketing authorisation is granted. Therefore, this type of medical device falls under the regulation of veterinary medicines.

--- Later in debate ---

[Lord Patel (CB) [V]]

I merely wish to ask the Minister about the consolidation legislation, to which he referred. Am I to understand that the Minister is saying that the Secretary of State will respond to Parliament, and that the matter will be available for debate?

[Lord Bethell (Con)]

I will get to back to the noble Lord with the specific answer to that question, if I may.

[Baroness Jolly (LD) [V]]

My Lords, I shall not detain the Committee for very long. I thank the Minister for his comments. I feel inclined at the moment not to withdraw my amendment, but I would like to read Hansard, consult and decide whether to return with these amendments, or something like them, on Report. I beg leave to withdraw the amendment.

--- Later in debate ---

Moved by

[Lord Bethell]

68: Clause 12, page 7, line 22, at end insert—
“(1A) The Secretary of State may only make regulations under subsection (1) if satisfied that they would promote the health and safety of the public.” Member’s explanatory statement
This amendment provides that the Secretary of State may only make regulations under subsection (1) of Clause 12 if satisfied that they would promote the health and safety of the public.

--- Later in debate ---

Moved by

[Lord Bethell]

72: Clause 12, page 7, line 23, leave out “making regulations under subsection (1)” and insert “considering whether they would”
Member’s explanatory statement
This amendment requires the Secretary of State to have regard to the factors mentioned in subsection (2)(a), (b) and (c) of Clause 12 in considering whether regulations under subsection (1) would promote the health and safety of the public.

--- Later in debate ---

Moved by

[Lord Bethell]

77: Clause 12, page 7, line 27, leave out paragraph (c) and insert—
“(c) the likelihood of the United Kingdom being seen as an attractive or favourable place in which to develop or supply medical devices.”Member’s explanatory statement
This amendment clarifies what was meant by the version of Clause 12(2)(c) in the Bill as brought from the House of Commons.

--- Later in debate ---

[Baroness Thornton (Lab)]

My Lords, I have greatly appreciated this debate, the expertise, and the explanations we have been given as to why the amendments are important. I particularly enjoyed the remarks by the noble Lord, Lord Ribeiro, about his hips: very important they are indeed.

Perhaps we should remind ourselves that Clause 16 was inserted in the Bill during the Commons stages after a cross-party effort involving the Labour Front Bench working with the Government. It provides for a data system to be set up by regulations to assist in tracking devices once they are implanted, so that safety performance and clinical effectiveness can be better monitored. The intention is that in the long term, that would support future device registries, allowing problems to be spotted earlier and patient harm to be prevented.

The amendments would tighten up that clause. The amendments tabled by the noble Baroness, Lady Finlay, are concerned with the operation of the tracker, using the devices’ unique identification. Currently, Clause 16 provides that unique device identifiers “may” be recorded as part of the data system. Quite rightly, the amendment would change that “may” to a “must”. So much of our work revolves around changing “may” to “must”.

Amendments 86 and 88 would amend Clause 13. Amendment 86 would require that UDIs should be considered as part of the packaging information on medical devices, and Amendment 88 would require that tracking devices used in individual procedures should be part of the Government’s consideration when regulating device registries. These amendments raise questions about the detail of device tracking. How will the unique identifiers be recorded and used? Those questions were raised by both the noble Baronesses, Lady Finlay and Lady Cumberlege. Will it be mandatory to record the unique device identifier in every procedure, and feed that into the data system? How can we ensure that that data is secure, and that it is recorded in the appropriate place? The Minister has those questions to answer at the end of the debate.

The noble Baroness, Lady Cumberlege, rightly addressed the issue of patient consent. She also underlined the fact that there is an opportunity in the Bill to get the law and the framework right. Amendment 103 would add to Clause 16 a requirement that the regulations must specify what information held by a data system is subject to a patient’s consent. The intention is that data held under the system should be used and shared to identify trends and trigger regulatory and clinical action where it is needed.

In her report, the noble Baroness cites the difference between a database and a registry. She is right to do so. The amendments explore the importance of the registry and the database, and the importance of patient consent —and whether we return to the subject at a later stage will depend on what the Minister now has to say.

[Lord Bethell (Con)]

My Lords, I am enormously grateful for that really important discussion of these critical amendments and provisions. I will take a moment to run through them in some detail. Device safety is absolutely critical to patient safety, and that is why the Government amended the Bill to include Clause 16. I pay tribute to my noble friend Lady Cumberlege, whose team helped inspire that amendment, and to the noble Baroness, Lady Finlay, who has participated in discussions on this clause. We have the benefit of her insight now.

Amendment 86 in the name of the noble Baroness, Lady Finlay, would add the unique device identifier number to the provisions in Clause 13(1)(g). These provisions currently allow the Secretary of State to make regulations about package labelling, provision of information and instructions for medical devices. UDIs would be one of the matters included within regulations made in reliance on Clause 13(1)(g), as drafted. It is therefore our belief that the amendment is not necessary.

The noble Baroness, Lady Finlay, and my noble friend Lord Ribeiro made important and fascinating remarks on Scan4Safety. I will limit my comments, which could be extensive, to the importance and value of that scheme. We are extremely supportive of the principle of fast and accurate traceability. Scan4Safety is not the only scheme of its kind, but it is a particularly good one. It is the hope that any UDI created by these regulations will empower these valuable services. We have a session on medical device information systems coming up in the diary, when I hope very much that we can discuss how that might work. If the concern of the noble Baroness is whether we intend to make provision to require manufacturers to provide a UDI, I reassure her that that would be a condition for being placed in the UK market.

Amendment 88 to Clause 13, as the noble Baroness, Lady Finlay, has indicated, is intended to support the tracking of devices used in medical procedures by recording the UDI in a register provided for in Clause 13 or within hospital episode statistics. I completely acknowledge the noble Baroness’s intent, but there is a difference between a register at Clause 13 and a database at Clause 16, or a registry. Clause 13 provides for a register or a number of registers. The register or registers we intend to create under Clause 13 will be a list of medical devices for sale on the UK market, held by the MHRA. It will not include the individual product identifier part of the UDIs and it will not contain data or monitoring information related to individual devices. The register forms part of wider market surveillance and vigilance activity. Regulations will be able to make provision requiring information to be entered into a register, such as the unique device identifier, which all manufacturers will be required to put on their devices. Amendment 88 is therefore unnecessary.

While the registers will enable some device identification to track individual devices, it is the information system, created under regulations made under Clause 16, which will ensure that devices and procedures are tracked in the event of a concern being identified, through which patients can be contacted and appropriate action taken in each case. The use of MDIS, which I will come on to, could prompt the MHRA to use the information in the register established under Clause 13 to identify the manufacturer and take action.

Amendment 102 would add information to be recorded in any information systems established under Clause 16. All the information set out in Amendment 102 can already be required under regulations made under Clause 16, but the regulations do not have to set out all those matters and can set out other descriptions of information.

A UDI may not always be available, such as for a custom-made device, so it may not always be possible for the providers to capture this. Amendment 102 would also require the recording of every procedure that related to a medical device. I have spoken before about the number of different medical devices on the market and that they vary greatly in risk profile. It would not be necessary or cost-effective to record every procedure related to a medical device, but they could be recorded in one of the registers provided for by regulations under Clause 12, as being on the UK market.

Amendment 103 in the name of my noble friend Lady Cumberlege deals with the important issue of patient consent. It would introduce an obligation that regulations made under Clause 16 would require the Secretary of State to set out the categories or types of information that are subject to patient consent that are held by the Health and Social Care Information Centre, otherwise known as NHS Digital, or by other persons.

My noble friend has raised this with me and with officials, and she is a tireless champion of patients. I am moved and affected by the accounts she has heard. As the testimony in her review shows, the absence of data in the healthcare system is absolutely medieval, and it is exactly the purpose of the Bill to fix that. Before any data can be collected relying on the provisions at Clause 16, regulations must be made. Those regulations are subject to consultation, as at Clause 41. It is absolutely right that the system is informed by patient views, and that the process is one where it is easy to engage, to understand what we want to do and to build consensus that it is the right thing.

My noble friend Lady Cumberlege has views on what data should be subject to opt-out versus opt-in. Privacy is a higher-order value that we should protect. The question of patient consent is really important. The noble Baroness, Lady Finlay, campaigned on the importance of opt-out organ donation and I congratulate her on her contribution to the recent change to organ donation privacy protocols, which are widely supported by the public and will save thousands of lives. She knows as well as I do that choosing to opt into measures is not as comprehensive as choosing to opt out. It is important to have enough data to draw conclusions.

Consent will not be required to input information about the surgical procedure and the UDI of the implanted device, linked to the patient, into the information system. The medical device information system is about protecting all patients who have had similar procedures, not just a particular patient. The detail of the specific device inserted, the procedure information and, if necessary, the effect that device has caused is what will be necessary for the information system to work. If there is no adverse report made by the clinician on behalf of that patient, that data acts as a control sample. It allows for other patients’ reports, where there have also been adverse reactions, to be understood as part of a wider data picture.

In her report, my noble friend raised the recommendation that detailed data should require consent in order that the data collected is necessary and proportionate. I reassure her that all data collected for the system will be necessary and proportionate. Data held by clinicians should be shared only under those circumstances, and data shared by the information system with, for example, a clinical registry for clinical assessment of whether there is an issue, should be only that which is necessary.

The intention is, that in the event there is a reported adverse reaction with a device, the medical device information system would send a report to a clinical registry. That report, suitably anonymised and stripped of patient-identifiable information but including the device UDI, would have the detail of all procedures, not just those involving adverse reactions, to further anonymise the incident. A clinical assessment would be conducted and, if it is concluded that the device is the issue, only relevant and necessary information would be sent to the MHRA to conduct its own tests.

This is a very important paragraph and one that I will emphasise. We do not need patient-identifiable information to determine whether compliance or enforcement action needs to be taken, but device information. There are routes to identifying that there are issues with adverse reactions when a clinical registry is not present, such as manufacturers’ reports or Yellow Card reports.

--- Later in debate ---

[Baroness Thornton (Lab)]

Can the Minister run it by me again how this will protect patients? I heard a lot being said about physicians and their reporting. I am not sure that I understand how this will avoid the problems with valproate and all the other situations with mesh unless “must” is used rather than “may”.

[Lord Bethell (Con)]

I can give a couple of illustrative examples if that would be helpful, but to run through the whole philosophy and system is probably beyond my ability or the time afforded by this Committee. In essence, the challenge identified by my noble friend Lady Cumberlege is that individual reports of adverse signals are not easily connected, unless those reports are somehow sent to a central registry and analysed by the kinds of experts who can spot mistakes and the connections made between those signals. This is how any problem identification system works. To do that process, you do not have to share personal details. You do not need the telephone numbers or personal identities of those concerned, but you need the clinical details and the full context in which signals have occurred. This pattern identification is often missing in the instances on which my noble friend reported. Having this information system, and analysis connected to it, will enable us to spot problems at a much earlier stage. Necessary interventions based on analysis and understanding will be much prompter and the connections made much more emphatic.

[Baroness Finlay of Llandaff (CB)[V]]

I am incredibly grateful to all noble Lords who have spoken in this debate. It has been very important and illuminating. We will all need to read the Minister’s words with care because there was an awful lot in them. I am most grateful to the noble Lord, Lord Ribeiro, for asking about the private sector, because if procedures are done in the private sector for patients who pay for themselves and those procedures are outsourced more and more, it will be important to make sure that this safety data is collected.

I am surprised that the word “must” is not being picked up. A supermarket will know how many tubs of mayonnaise it has ordered and which factory they came from. If there is glass in jam, a supermarket can track it back to the factory where the glass was. If we do not have complete data collection systems, we will find that all the places that are functioning above average will do really well. They will collect the data properly, and so on. But 50% of places are below the average line—that is the nature of an average. All patients need to be protected and standards need to be driven up. I was grateful to the noble Baronesses, Lady Walmsley, Lady Redfern and Lady Jolly, for elaborating on aspects of points that I have made, and particularly grateful to the noble Baroness, Lady Thornton, for giving us the history of the amendment and asking again how this would work in practice.

Consent is critical. Patients going into a hospital expect all the equipment to be safe and to be known about. They expect the fire alarms to work and that the oxygen pipes to anaesthetic machines are correctly positioned and known about, and that full servicing data is available. It is important. Here I should declare that I was a very junior doctor in a hospital, but on the periphery, when an anaesthetic accident happened many years ago. It was critical that things could be traced back urgently. Unfortunately, there are tragedies, even when it is possible to do that.

We need to be able to look right across the whole system. There is the safety aspect—the tracking and quality control—that goes along with all the routine procedures. If something faulty is used in 15 hospitals around the country, that needs to be known rapidly and safely. I, too, worry about relying on clinicians to report if there is a problem, and I rather felt that the Minister’s answer underlined the call for a distinct commissioner for safety. The noble Baroness, Lady Cumberlege, has been calling for that because we need somebody who can interrogate and analyse the data, and look at it carefully. She explained consent for patient details extremely well. The Montgomery test of consent is that you should be given the information that other reasonable people would expect. It is almost the Clapham omnibus test of what patients should be told.

This is not about what the clinicians want or do not want to tell patients. They might feel it unnecessary to tell them something, but most patients would want to know about it and therefore it should be disclosed to patients. A doctor might say, “This can happen, but it has never happened to me”, but they still have a duty to disclose. Linked to that consent, I would like us to have routine processes in clinical practice for consent data to be entered into a registry. Patients could opt out and say that they did not want it to be entered, so that box would not be ticked; their scanned-in data would then not be sent on with the additional information.

This debate has been incredibly important. It gets right to the nub of patient safety. I hope that the Minister will meet me and the noble Baroness, Lady Cumberlege. I have to say to the Committee that I am pretty convinced that we will return to this on Report because there is a lot more to do. However, we have another group of amendments to move on to, and that debate will be interesting and informative, so I beg leave to withdraw the amendment.

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[Baroness Thornton (Lab)]

This amendment is interesting and certainly worthy of consideration. The innovative medical devices fund would insert a new subsection into the National Health Service Act 2006. Section 261 provides powers for the Secretary of State in relation to voluntary schemes to control the cost of medicines. The section describes these as schemes that are joined voluntarily and limit the price that may be charged on the profits that may accrue from the manufacture and supply of health service medicines. The scheme also provides for manufacturers and suppliers to pay the Secretary of State an amount of money if the agreed limits are breached. Amendment 91A would create a voluntary scheme under Section 261 which would be specifically for medical devices to give them equal treatment as innovative medicines. The Minister will have to explain why that would not be a good idea.

In her speech at Second Reading, the noble Baroness, Lady Finlay, talked about making the UK a medical devices development and production hub. Too often the UK effort has been bought out by overseas manufacturers who then market the devices back to the NHS at great profit.

[Lord Bethell (Con)]

My Lords, Amendment 91A seeks to replicate the innovative medicines fund with a comparable fund for medical devices called the innovative medical devices fund. We have had a terrific debate on this. The ideas and insights shared by noble Lords have been extremely powerful, but perhaps I may address the points in turn.

The goal that is shared wholeheartedly by the Government is that we recognise the huge benefits that medical devices can deliver. My noble friend Lord Lansley and the noble Lord, Lord Hunt, put that particularly well. We recognise the astonishing pace of innovation and development that is creating new healthcare options for patients across the UK. In fact, that is one of the reasons we are considering this Bill. We are extremely ambitious and are determined to capitalise on the opportunities presented by new medical technologies to ensure that the best innovations are adopted and spread across the NHS.

Devices, like medicines, are key to ensuring patient health, but they are different and it is not necessarily helpful to use a system that was developed for medicines to be used for devices. For example, the primary purpose of the innovative medicines fund is to cover the cost of managed access agreements where NICE feels that there is insufficient evidence to give a positive opinion and asks for further evidence to be collected before the product is re-evaluated.

Devices are not assessed by NICE in the same way and we do not consider that mirroring the provisions for medicines would necessarily be beneficial. In particular, unlike medicines where, once licensed, they do not change, medical devices are constantly evolving. New iterations of medical devices are developed quickly, their impact on patients changes, often rendering earlier iterations completely obsolete within relatively short periods of time. That gives rise to the potential for funding mandates to be in place for devices that are no longer the best or most cost-effective in their category. Requiring the mandatory purchase of all but the most innovative devices by commissioners would not be a sensible use of NHS funds. We therefore need to find different systems of process to ensure that innovative and effective devices, along with other medical technologies such as digital, find their way to the NHS and to patients.

That is why we have boosted the remit of the Accelerated Access Collaborative. It will bring together leaders from across Government, the NHS, regulators and industry to address the underlying challenges that delay patient access and uptake.

As chairman of the AAC, the noble Lord, Lord Darzi, has been able to bring his world-leading expertise to bear to deliver a host of successes in recent years. Indeed, almost 750,000 patients have benefited from access to AAC-supported innovations in recent years, including more than 315,000 patients who have accessed new technologies supported through the innovative technology payment programme. The AAC is going further to deliver the commitment in the NHS Long Term Plan to accelerate the uptake of proven, affordable innovations with the introduction of a new medtech funding mandate. The mandate will ensure that all patients have faster access to selected cost-saving devices, diagnostics and digital products approved by NICE, via medical technologies guidance and, when available, NICE diagnostic guidance for innovations.

The final criteria to be used in the mandate will be announced in the consultation response to be published in December this year, and the mandate will take effect from April 2021. Additional steps are being taken to ensure that the mandate translates to front-line improvements in patient access. The NHS standard contract has already been updated to state that the relevant parties must comply with their obligations under the mandate guidance, and technologies receiving the mandate will benefit from dedicated support via the regional academic health sciences network to help drive local adoption and spread.

NICE also recognises the need to ensure its methods for assessing innovative medical technologies continue to support our ambition for the NHS to provide world-leading care that delivers value to patients and the NHS. The NICE methods review is therefore under way, with extensive input from industry and patient representative groups. The consultation on the case for change to existing NICE methodology is open until 18 December, and I encourage all those interested to submit their views.

Finally, it is also important to note that in her amendment the noble Baroness, Lady Finlay, stated that moneys should be paid to the Secretary of State under Section 261(9) of the National Health Service Act 2006 in order to support an innovative medical devices fund scheme. However, Section 261 of the National Health Service Act relates only to voluntary schemes agreed with pharmaceutical manufacturers which control the prices charged, or profits accrued, by manufacturers and suppliers of health service medicines. The vast majority of medical devices would not therefore be within the scope of such a scheme.

I trust that I have been able to reassure the noble Baroness that the funding of medical device technology in the NHS in England is of great importance to the Government and that we are actively putting in place mechanisms to support it. On this basis, I hope very much that the noble Baroness, Lady Finlay, will feel able to withdraw her amendment.

[Baroness Finlay of Llandaff (CB) [V]]

My Lords, I thank noble Lords for contributing to this debate. There were a couple of comments that I would like to come back on.

The noble Lord, Lord Lansley, asked whether there was evidence of the slow adoption of innovation. I have a series of different case studies that I will happily share with him. I shall highlight one. Cytosponge had a 19-year journey from when it was thought of to when it was adopted. It is estimated that it saves 7,190 QALYs having now gone through NICE. Companies do not feel incentivised to develop low-cost devices in this country.

Another example is the CoMICs study on conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery, which compared two types of bypass machines. The difficulties there resulted in most of the study going abroad and being conducted elsewhere. Our development of robotics has been impressive, but we have huge competition from the US market, in particular in device development.

So I suggest that we need to look at a way of making sure that we can develop devices. I accept that this amendment as worded may not be right for this Bill at this time, but I hope that we will not lose sight of the need to innovate. I would like to come back on Report to the concept of provisional licensing as a way of getting new and innovative devices through the system rapidly, possibly without burdening the NHS with the financial bureaucracy that this amendment might cause. I beg leave to withdraw the amendment.

Covid-19: Dental Services

Lord Bethell Excerpts

Tuesday 10th November 2020 Lords Chamber

[Baroness Walmsley]

To ask Her Majesty’s Government what measures they are taking to ensure the continued provision of dental services during the COVID-19 pandemic.

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

My Lords, the challenge presented to the dental profession by Covid is severe. We are grateful for the hard work of 10,000 NHS and private practices in introducing PPE and infection-control arrangements to keep patients and staff safe, and to the 600 urgent care centres that are providing services for the most severe cases. However, the impact on the nation’s health remains something that we are working hard to mitigate.

[Baroness Walmsley (LD) [V]]

My Lords, I thank the Minister for that reply, but 60% of dentists can now see only a quarter of their usual number of patients, particularly because of the measures needed for carrying out aerosol-generating procedures. There is a backlog of 15 million treatments, and many dentists are in danger of going out of business. They cannot afford ventilation equipment, which would enable them to see more patients in a day. Will the Government provide funding for this, so that the backlog of patients can be cleared?

[Lord Bethell (Con)]

My Lords, I completely acknowledge the challenge that the noble Baroness has described. Many dentists can see only 20% of their normal cases, and around half can see about 50%. The backlog is, as she describes it, severe, and the impact, particularly on private dentists, has been very hurtful for their businesses. I cannot make a commitment to fund ventilation arrangements, but we acknowledge the scale of this challenge and are looking at ways to mitigate it, including bringing in testing, which we hope would help provide a safe environment for both staff and patients.

[Baroness Uddin (Non-Afl)]

My Lord, the Minister will be aware that people with learning disabilities and autism have suffered disproportionately in not receiving care and services. Will he undertake to ensure that they are not equally suffering by not receiving dental services, especially specialist dental provisions? I declare that I have a 41 year-old son with a learning disability and autism. I have spoken to a number of organisations that said that the pandemic exacerbated the difficulties in the process of receiving important and urgent care.

[Lord Bethell (Con)]

My Lords, the noble Baroness refers to the prioritisation of patients in the constrained appointment flow of dentists. She is entirely right that those who have vulnerabilities, disabilities or other disadvantages should be prioritised: that is the objective of the prioritisation process. She makes the point extremely well and I am happy to take on board any points on where she thinks the system is not working as well as it might do.

[Baroness Altmann (Con) [V]]

My Lords, will my noble friend the Minister tell us what lessons have been learned from the initial response to the Covid pandemic and the blanket closure of dental practices? Does he have any estimates of the number of cancers of the head and neck that might not have been detected because people have not had regular dental check-ups?

[Lord Bethell (Con)]

My Lords, my noble friend is right to allude to the confusion around the closure of dental practices. We have made it crystal clear that in the second lockdown all dental practices—both NHS and private—should remain open; that is part of our commitment to try to clear the backlog. I also acknowledge her concerns about the diagnosis of cancers. I do not have the figures for which she asked, but we certainly appreciate the role that the dental sector plays in detecting many cancers, including oral cancers. Dental services are open to those seeking urgent care and we hope that those urgent care clinics to which I referred earlier can provide some diagnostic analysis in urgent cases.

[Baroness Finlay of Llandaff (CB) [V.]]

My Lords, I declare my role as chair of the National Mental Capacity Forum. Following on from the question of the noble Baroness, Lady Uddin, will the Minister say how the urgent care pathway is being evaluated, particularly for children and young people with learning difficulties who might need a general anaesthetic for dental work? They are at a particularly high risk of sepsis from dental abscess, which can be avoided by preventive dentistry, yet they are often part of the increasing backlog and have difficulty registering with a dentist locally because they need even more time for their care than other patients and will therefore decrease the number of other patients whom the dentist can see.

[Lord Bethell (Con)]

My Lords, the concern about children is particularly acute. We are especially keen to encourage parents, to ensure that they are still bringing children forward. That is why we have the Help Us to Help You campaign to encourage public access to NHS services. She is entirely right that acute situations—involving, for instance, some form of anaesthetic—provide a particular challenge. We have a prioritisation process in place, and I understand that that is working well to ensure that those who have the greatest need are put at the front of the queue. However, as I said to the noble Baroness, Lady Uddin, I would welcome any feedback from those who think that the system is not working well enough.

[Lord Hunt of Kings Heath (Lab) [V]]

My Lords, I declare my interest as president of the British Fluoridation Society. Just on that last point, in a number of parts of the country, no elective surgeries, except for those that might be totally prioritised, are being done at the moment. The prospect is of a few more months with a virtual lockdown of elective surgery. As far as children are concerned, will the Minister look into this matter urgently? Will the Government prioritise preventive schemes as we come out of the pandemic, such as fluoridation, supervised tooth-brushing programmes in schools and public service ads?

[Lord Bethell (Con)]

My Lords, I completely agree with the noble Lord that prevention is the key. In our document on the matter, Advancing Our Health: Prevention in the 2020s, we have committed to the consulting on and rolling out of supervised tooth-brushing schemes in more preschool and primary school settings in England. We have also set out our support for expanding water fluoridation, and we intend to announce further details of our water fluoridation plans shortly.

[Lord Strasburger (LD) [V]]

My Lords, as rapid coronavirus testing becomes more available, can the Minister assure the House that dentists and their staff will not be left behind? Will they also be included with health and care staff near the top of the priority list when new vaccines are being distributed?

[Lord Bethell (Con)]

The noble Lord asked for a general commitment on dentists and their staff. I reassure him that we value the dentist profession and their staff, and the Covid pandemic has only emphasised the importance of dentists in the community and to the nation’s health. He asked me a specific question about where they stand in the vaccine prioritisation list and whether they are on the healthcare list. I will write to him with a precise answer to that question.

[Lord Flight (Con) [V]]

My Lords, there are three big factors that are causing these problems. First, there is the potential patient’s caution and the worry of contracting Covid-19, which leads them to put off treatment and save the money until normal times return. Secondly, dental sessions are taking much longer, partly because of the fall in the number of patients per session and lower throughput. The principal barrier to resuming services is the issue of the fallow time required following aerosol-generating procedures. The solution is greater ventilation. The key need is to increase the patient throughput and to reduce—

[Lord Flight (Con) [V]]

Will the Government be willing to put up any funding to deal with the issue of fallow time between treatments?

[Lord Bethell (Con)]

My Lords, I agree with the noble Lord’s analysis, but it is too early to make commitments on funding.

[The Lord Speaker (Lord Fowler)]

I make the point that I say at the beginning of every Question Time that two points are the maximum that should be made.

[Baroness Thornton (Lab)]

In my view, the Government have offered little support to dentist practices: not exempting them from business rates, even though book- makers and vape shops are exempted, and not offering them key worker status, which has caused problems with childcare. Can the Minister commit to early access to Covid-19 vaccines for all high-street dentists who are NHS contractors, rather than employees? Can the Minister give them key worker status?

[Lord Bethell (Con)]

My Lords, one area where the Government have made a big commitment to dentists is in PPE. As of Wednesday 4 November, over 5,000 dental and orthodontic providers in England had registered with the PPE portal and over 36 million items of PPE had been delivered. In terms of the commitment to workers, I will have to come back to the noble Baroness.

[Baroness Bull (CB)]

My Lords, I declare my interests as set out in the register. Reduced clinical capacity not only impacts on patients but massively disrupts the education of dental students, who typically treat over 400,000 volunteer patients each year as part of training. Since March, many schools have been unable to provide any patient-facing education at all. Will the Government respond to requests from dental schools and hospitals to invest in high-quality simulation facilities, to mitigate the impact of this reduced clinical experience and ensure that students can graduate and provide the workforce of the future?

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, the bottleneck around the training of new dentists, an incredibly important priority for the nation’s teeth, is one that the CDO is extremely concerned about. The question of simulation machines is not one that I was aware of but I will be happy to look into it and reply to the noble Baroness on how we can make progress.

[The Lord Speaker (Lord Fowler)]

My Lords, the time allowed for this Question has now elapsed.

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

Lord Bethell Excerpts

Tuesday 10th November 2020 Lords Chamber

Moved by

[Baroness Bloomfield of Hinton Waldrist]

That the draft Regulations laid before the House on 8 October be approved.

Considered in Grand Committee on 2 November.

[Baroness Bloomfield of Hinton Waldrist (Con)]

My Lords, on behalf of my noble friend Lord Bethell, and with the leave of the House, I beg to move the four Motions standing in his name on the Order Paper en bloc.

Covid-19 Regulations: Assisted Deaths Abroad

Lord Bethell Excerpts

Tuesday 10th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, I think it is to be welcomed that the response to the Urgent Question last week was that travelling for the purposes of an assisted death would be exempt from lockdown travel restrictions. However, there are concerns that this Statement did not go into detail about whether family members could accompany people. Legal constraints mean that it is not clear whether the exemption applies to them. Presumably, they would have to demonstrate their reasons for travel and might, in the course of doing so, incriminate themselves for assisting a suicide. So can the Minister clarify that family members accompanying someone travelling for an assisted death will not be vulnerable in this way? If the Minister does not know the answer in detail to this important question, please would he seek to find out from the Ministry of Justice, write to me, and put the letter in the Library?

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

The noble Baroness is entirely right on the question of travelling abroad for the purpose of assisted dying. It would be regarded as a reasonable excuse, and therefore anyone who did would not be breaking the law. In answer to the noble Baroness’s question, under Section 2(1) of the Suicide Act 1961, a person does commit an offence if he or she

“does an act capable of encouraging or assisting the suicide or attempted suicide of another person”

and that act

“was intended to encourage or assist suicide or an attempt at suicide.”

The 1961 Act provides no exceptions to the prohibition on assisting suicide. The maximum penalty, as noble Lords may know, is 14 years, and there is nothing in the Coronavirus Act or any recent legislation that in any way changes that.

[Lord Purvis of Tweed (LD)]

My Lords, whilst the 1961 Act provides no exemptions, as the Minister said, the Director of Public Prosecutions has issued guidance with regard to the avoidance of prosecution in this area. Will the Government ask for that guidance to be looked at again, in the context of the sensitive words of the Secretary of State for Health, to avoid the very situation that has happened in the past where public authorities sought injunctions against family members who supported those who took the very difficult decision to travel abroad? I live in Scotland, where the Suicide Act 1961 has never applied. Will the Government work with the Scottish Government to start collecting data? It was welcome that the Health Secretary indicated the openness of the Government to do that, so we can get a proper understanding of how many people are making the very difficult decision to travel abroad.

[Lord Bethell (Con)]

The noble Lord is entirely correct; the Director of Public Prosecutions’ policy for prosecutors in respect of cases of encouraging or assisting suicide sets out factors which prosecutors in England and Wales will consider, in addition to those already outlined in the code for Crown Prosecutors when deciding whether it is in the public interest to prosecute in cases of encouraging or assisting suicide. Among the public interest factors tending against prosecution are that the victim had reached a voluntary, clear, settled and informed decision to commit suicide and that the suspect was “wholly motivated by compassion”. I completely take on board the noble Lord’s encouragement of this review. There is no review planned, but we all acknowledge the changing tone of this debate and I will take his suggestion back to the department. On the point about Scotland and data, I acknowledge different circumstances in Scotland and the remarks on the importance of collecting data from my noble friend in the other place. That is indeed our intention.

[Baroness Hayman (CB) [V]]

My Lords, the Minister’s response to the second question today was more reassuring than his response to the first. I am sure he would agree that these are desperately difficult situations for families, and to have the uncertainty about whether someone would have to undertake alone a journey that should never be undertaken alone because of a wish to protect their relatives from prosecution is frankly unthinkable. On the wider point, could he assure the House that some urgency will be given to this issue of collecting data and seeing in the round the problems that are being caused? We have had piecemeal changes such as the changes from the DPP, but we need to understand more comprehensively the exact implications of what is going on.

[Lord Bethell (Con)]

The noble Baroness is entirely right; Covid has, in a very sad way, thrown a spotlight on the circumstances of those dying alone. That is one of the harshest and most heart-breaking dimensions of this awful pandemic. It throws a spotlight in particular on the way in which the law is applied in this country. The collection of data is a very important component of our review of this important area and I will definitely ensure that the indication given by my right honourable friend in the other place is picked up back at the department.

[Baroness Jay of Paddington (Lab) [V]]

My Lords, I am generally encouraged and relieved by the Government’s responses on this Statement, particularly the point made in the Commons by the Secretary of State that assisted dying must be considered in the general discussion of good end of life care. I hear the Minister say that a formal review is not planned, but when the Government come to look at the concerns about death and dying that have been thrown up by the pandemic, will they ensure that the questions of proper personal choice at the end of life will be both included and emphasised?

[Lord Bethell (Con)]

Well, this is an extremely complex issue. As the noble Baroness alluded to, there is a wide variety of issues at stake, including values issues, questions of faith and, as she rightly said, questions of personal choice. There are the components here for an important national debate. I acknowledge the comments of several noble Lords already that we are approaching the moment when that debate seems more relevant than it has ever done. When that debate takes place, certainly personal choice will be an important part of it.

[Baroness Grey-Thompson (CB) [V]]

What advice did the Secretary of State, Matt Hancock, have from the Director of Public Prosecutions in relation to the official guidance? The response on travelling to Dignitas suggests assisting suicide is an urgent act and encourages the suicide of those with disabling conditions. Some 25 years on from the Disability Discrimination Act, and with the rise in post-Covid mental health problems, this is particularly inappropriate, as data from other countries shows that the major driver for seeking assisted suicide is the fear of being a burden, and other social factors.

[Lord Bethell (Con)]

In direct answer to the noble Baroness’s question, I am not sure whether any advice was given by the DPP, because there has been no change in the law. Nothing we have done here changes in any way either the 1961 Act or the advice of the DPP. So, from that point of view, the consultation is not necessary. What we have sought to do is clarify travel guidance in a way that does not change the application of the law in the country.

[Baroness Jenkin of Kennington (Con) [V]]

My Lords, the Secretary of State said in the other place that this conversation on assisted dying must happen

“in an evidence-based, sensible and compassionate way.”—[Official Report, Commons, 5/11/20; col. 480.]

What efforts will the Government be making to ensure that we as a House have all the evidence available to us when this important debate next reaches the Chamber?

[Lord Bethell (Con)]

My Lords, the debate has not been scheduled, but evidence that would be of interest includes evidence from clinicians themselves, many of whom have seen some movement in their attitudes on this subject. There is also an enormous amount of values-based and faith-based evidence from those who have a particular view on this subject. There is also the evidence of the personal choices of those approaching death themselves. There are extremely moving testimonies by individuals faced with very daunting and challenging circumstances. All of these views have relevance and value, and they should all be part of this important and delicate debate.

[Baroness Stuart of Edgbaston (Non-Afl)]

My Lords, in response to the noble Baroness, Lady Grey-Thompson, the Minister stressed that this was travel advice, but surely it goes further than just travel advice. At a time of Covid, when many people in care homes would seek the companionship of members of their families but forgo it in the wider community interest, is it really the right decision to create a presumption that people at the end of life only have the option to travel abroad and to facilitate that? Surely more palliative care and more focus on helping people to a good death are more important during this Covid crisis than facilitating people to travel abroad.

[Lord Bethell (Con)]

I entirely agree with the noble Baroness that the contribution of hospices and the role of those involved in palliative care has been an incredibly important part of the Covid crisis, and it has given huge succour, compassion and care for those at the end of their life. We have sought to help with the financing of the hospice community with a substantial £150 million payment in the first wave, and there are currently talks in place on funding for hospice care through the second wave. Hospices’ work is enormously valued, and anything in this debate does nothing to underplay the value of the role that they play at the end of people’s lives.

[The Deputy Speaker (Lord Haskel) (Lab)]

My Lords, the time allowed for this Question has now elapsed, so I move to the next item of business.