DHSC Answers to Written Questions

Lord Bethell Excerpts

Wednesday 25th November 2020 Lords Chamber

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

My Lords, the very large number of questions which have been put to the Department of Health is completely unprecedented. We had 577 in the whole of 2019. So far in 2020 we have had 1,783, of which 799 have been answered on time and the rest are late. I apologise for that; it is a matter of huge regret. I ask for the forbearance of the House, as the pandemic has put enormous pressure on the department.

The noble Baroness, Lady Thornton, quite correctly alluded to one aspect of the answering of questions: the questions themselves often address novel challenges. Traditionally, we get questions about things that the department has been doing for years and years, where it is easy to pluck out an answer from the database or from the encyclopaedia of answers. The noble Baroness gave a good example of a question where it is difficult to elicit an answer. I know the exact question she referred to, because I have sought really hard to provide an answer to the noble Lord, Lord Bassam. The question of how many swabs have not been returned by post is much more complicated than it might look. There are different types of swabs; different schemes—ONS, REACT, clinical trials—send in the swabs. Inconveniently, they do not pool all the answers. Also, some swabs may sit on a bench or in a cupboard at a house for a long time and it is not possible to know when they are, or are not, sent back.

I cite that as an example of the kind of challenge that we have faced in answering questions from noble Lords. I am not trying to detract from the inconvenience of questions not being answered on time, but I assure the House that we have put in considerably more resources. We have upgraded the quality of the people who are answering the questions and have an absolute commitment to trying to answer them on time.

[The Lord Speaker (Lord Fowler)]

My Lords, I remind Ministers that the instruction to be brief applies to their answers, as well as to questions from other Members.

[Lord Robathan (Con)]

My Lords, I do not underestimate the pressure under which the Department of Health has been put and pay tribute to my noble friend for the number of times that he comes here to answer Questions. However, the data behind this virus is hugely important. I put down a Question asking about the number of NHS workers—doctors and nurses—who have been killed by the virus. The answer that came back was: “We don’t know”. Surely, we must know this. I have also asked a question in this Chamber, not a written one, about what the strategy is without vaccinations. A vaccine has now come, but we must know what the strategy is. Are we going to go into another lockdown if the infection rate rises again? Perhaps the Minister can answer that now?

[Lord Bethell (Con)]

My Lords, matching the data on deaths with the HR records of the NHS is actually very difficult. It cannot be done easily, or even accurately. Our strategy is crystal clear: to protect the NHS, keep the schools open and encourage the economy while we wait for the vaccine to be deployed.

[Baroness Whitaker (Lab) [V]]

My Lords, I am grateful for the answer from the health department on 24 November to my letter of 8 June about the disparity of health outcomes from Covid-19 for Gypsies, Travellers and Roma, although it did not answer our specific questions and was sent only to my cosignatory, Kate Green MP, not me. Will the Minister please answer my question of 21 October, due to be answered on 4 November, asking whether the Government would recognise International Stammering Awareness Day, now long past, with better technological provision for speech and language therapists, which is sorely needed?

[Lord Bethell (Con)]

My Lords, I would be glad to track down the noble Baroness’s letter and get her the answer that she so desires.

[Lord Wills (Lab) [V]]

My Lords, I have every sympathy with the unique pressures being placed on the Minister and his department this year. It was inevitable that mistakes would be made, but the crucial thing is to learn from them, not least because, however encouraging recent news has been, there are still considerable challenges to be overcome before the country can return to normal. When Ministers refuse even to address questions asked of them, it hardly encourages belief that they are prepared to learn lessons from recent months. I have asked many questions about the failure to utilise efficiently the much-needed capacity provided by the partnership between the private sector and the NHS. The responses were a masterclass in a wilful refusal to answer questions. Does the Minister not recognise the damage done by such public denial of the facts?

[Lord Bethell (Con)]

My Lords, I regret enormously that the noble Lord feels that we have, in any way, avoided the facts. We are absolutely committed to learning the lessons of Covid, which will be profound. I note that my right honourable friend the Secretary of State was in front of the House of Commons Select Committee on health for two and a half hours yesterday, answering exactly those questions. It was an illuminating and important discussion and I very much hope that this House will have an opportunity to do the same.

[Lord Randall of Uxbridge (Con) [V]]

My noble friend is, I am sure, aware of the frustrations that the House has just heard. Here is a question to which I do not expect an answer, perhaps, at the moment. How many officials are actually involved in having to provide these answers? Does my noble friend agree that accuracy of responses is more important than speed?

[Lord Bethell (Con)]

My Lords, before the pandemic the parliamentary affairs team was made up of nine people; it has grown to 15. The ministerial correspondence and public inquiries team has grown from 51 people to 111. I think the noble Lord would agree that, at a time when we are trying to deal with test and trace along with programmes on therapeutics, restart, seasonal flu, PPE and vaccines, having 111 people working on correspondence seems the outer limit of what would be proportionate.

[The Lord Speaker (Lord Fowler)]

My Lords, all questions in this section have now been asked. We will come to the next in a moment.

Nutrition (Amendment etc.) (EU Exit) Regulations 2020

Lord Bethell Excerpts

Wednesday 25th November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Nutrition (Amendment etc.) (EU Exit) Regulations 2020.

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

My Lords, nutritional-related labelling, composition and standards are regulated to protect public health. It is essential that food businesses and enforcement officers understand the specific nutrition-related rules that must be complied with. This instrument enables that, making technical amendments to ensure that the regulatory framework remains functional throughout the UK from 1 January 2021. It implements no policy changes.

Trade from Northern Ireland to the rest of the UK will take place as it does now. At the end of the transition period, businesses in any part of the UK may continue to place their goods in any part of the UK internal market without new restrictions.

Primarily, this instrument reflects the Northern Ireland protocol by amending the Nutrition (Amendment etc.) (EU Exit) Regulations 2019 and revoking the Nutrition (Amendment) (Northern Ireland) (EU Exit) Regulations 2019. It also remedies deficiencies in retained European Union nutrition legislation which have come into force since March 2019. It delivers continuity for businesses and consumers by allowing nutritional products to be manufactured and sold to the same world-leading standards.

By way of background, I am sure that everyone will welcome a brief summary of the 2019 regulations. Made in preparation for our exit from the EU, those regulations make technical amendments, changing redundant EU-specific references and transferring functions and powers currently held by the European Commission to the appropriate authorities in each of the UK’s constituent nations. This is with the explicit aim of mirroring the existing regulatory system following the end of the transition period.

However, this instrument is now needed to give effect to the Northern Ireland protocol, which was agreed last year. The protocol requires that EU legislation is continued in its application in Northern Ireland. Consequently, the instrument removes Northern Ireland from the scope of the 2019 regulations and changes UK-specific references to Great Britain, preventing functions being transferred from the European Commission to the Department of Health in Northern Ireland.

Furthermore, the instrument revokes the 2019 Northern Ireland regulations, which amended domestic nutrition legislation in Northern Ireland in preparation for the end of the transition period. These amendments and revocations see that EU nutrition legislation continues to apply in Northern Ireland and that our obligations under the protocol are met. The instrument also remedies deficiencies in retained EU nutrition legislation that have come into force since 2019. These concern infant formula and health claims that can be made about foods.

The devolved Administrations have been involved in this instrument’s preparation and have consented to it. Further to this, we have provisionally agreed a common framework for nutrition that will maintain existing standards and promote common approaches to nutrition policy in the future. I am grateful to the Administrations for their continued collaboration.

Scrutiny by the House of Lords Common Frameworks Scrutiny Committee and committees in the Northern Ireland and Welsh Assemblies have now been completed, and their valuable input is currently being considered.

Furthermore, the draft instrument was the subject of a four-nation public consultation in July. Respondents represented sector stakeholders across the UK, including trade bodies, local authorities and businesses, with the majority supporting our approach. The Government’s response to the consultation was published on 24 September. Since then, my department has updated guidance for businesses regarding practical changes to nutrition legislation from 1 January 2021. That, too, was tested with stakeholders and published on GOV.UK on 17 November.

This instrument proposes no significant changes and, consequently, we estimate that there will be no significant impact on industry or the public sector. I assure noble Lords that the SI will provide continuity for business and consumers following the end of the transition period and uphold our obligations under the Northern Ireland protocol. I beg to move.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I thank all noble Lords for their extremely valuable contributions to this important debate. This statutory instrument is incredibly important. However, I reassure noble Lords that it does no more than is absolutely necessary to reflect the Northern Ireland protocol in law, ensuring that our obligations under the withdrawal agreement are met and to remedy some deficiencies in retained EU nutrition legislation, and that its passage is critical to ensuring a functioning regulatory system across England, Wales, Scotland and Northern Ireland.

My noble friend Lord Bourne asked why the consultation occurred over such a short period and why it had seemingly so few responses. The engagement was as expected. It reflected probably the contentiousness of the proposals or otherwise, and it very much followed Cabinet Office consultation and guidelines. As such, it completely met the expectations of those who managed the consultation process. It was none the less an incredibly valuable process and we are extremely grateful to all those who participated in it.

I pay my respects to the expertise of the noble Baroness, Lady Ritchie, in this matter and thank her very much for her kind comments about the arrangements and the process. In essence, her questions were largely about what provisions we were making for policy divergence. I reassure her that no divergence is anticipated. We are not putting in place mechanisms for divergence, because we are not planning to create it. We are simply reading across the current legislation and putting in place through this SI mechanisms to ensure that it can stay in place.

The noble Baroness, Lady Ritchie, asked about prohibited foods versus allowed foods. The list of prohibited foods to which she refers is out of scope of this instrument. However, the UK is proud of its world-leading food, health and animal welfare standards, not least those which relate to nutrition. We will neither lower our standards nor put the UK’s biosecurity at risk as we negotiate new trade deals. I can assure the noble Baroness that the Government remain committed to promoting robust food standards nationally and internationally and to protecting consumer interests to ensure that consumers can have confidence in the food that they buy.

The noble Baroness, Lady Thornton, also asked about maintaining standards. I reassure her too that we do not currently envisage divergence. Were divergence ever to hove on to the agenda, we would of course consult on any new regulations, and that would be the time to take on board comments from industry. If a common approach cannot be agreed or would not be appropriate for one or more nations, and divergence between the UK nations occurred, the UKIM Bill provides for goods made and labelled in any of the UK nations to be recognised and sold in any of the others, subject to the NIP, without discrimination.

I hope very much that I have been able to answer the questions raised by noble Lords, and with that in mind I commend these regulations to the Committee.

Motion agreed.

Coronavirus Act 2020 (Expiry of Mental Health Provisions) (England and Wales) Regulations 2020

Lord Bethell Excerpts

Wednesday 25th November 2020 Grand Committee

Moved by

[Lord Bethell]

That the Grand Committee do consider the Coronavirus Act 2020 (Expiry of Mental Health Provisions) (England and Wales) Regulations 2020.

Relevant document: 33rd Report from the Secondary Legislation Scrutiny Committee

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

My Lords, I am pleased to speak in support of the regulations, which were considered and agreed to in another place on 18 November. During the debate on the six-month review of the Coronavirus Act held in September in the other place, my right honourable friend the Secretary of State for Health and Social Care announced the Government’s decision to sunset the emergency provisions to allow for temporary easements of the Mental Health Act 1983 in England, as they are no longer necessary. These provisions may be found in Schedule 8 to the Coronavirus Act. The regulations therefore seek to enact this decision and so expire provisions in Schedule 8 to the Coronavirus Act 2020.

The emergency provisions, which these regulations seek to remove, were introduced to protect the safety of patients by ensuring that mental health services could continue to provide vital care and treatment if there were extreme staffing shortages during the pandemic. The need for them has been kept under continual review, particularly as the Government are extremely conscious that the provisions, had they been commenced, would have had serious consequence for individuals involved.

We are pleased that, due to the resilience and resourcefulness of the NHS in England and its staff, the provisions have not been commenced as they have not been needed. It is huge testament to the dedication and dynamism of NHS staff that mental health services continue to be able to provide support to people detained under the Mental Health Act, while under the extensive pressures resulting from the pandemic.

The Government, NHS England and NHS Improvement have taken a huge range of steps to support mental health services so that, despite ongoing workforce pressures resulting from the Covid-19 pandemic, they can continue to deliver vital care and treatment to individuals. The department and NHS England and NHS Improvement issued Legal Guidance for Mental Health, Disability and Autism, and Specialised Commissioning Services Supporting People of All Ages during the Coronavirus Pandemic. That guidance set out how the Act’s code of practice may be interpreted during this period. For example, it allows for the delivery of statutory forms electronically to allow mental health staff to work more flexibly and reduce risk of Covid infection. It also set out how video technology can be used for medical assessments to be carried out remotely under the Act, to make it easier for two doctors to examine a patient during the pandemic period.

The department has also supported the Care Quality Commission in bringing in a modified second opinion appointed doctor—SOAD—service, which allowed this service to work remotely. This enabled procedures around assessing and approving the medical treatment of patients detained under the Act to continue as normal, rather than enacting powers that would lessen this important safeguard. These measures, coupled with the resilience and innovation of mental health staff, have been effective in mitigating pressures on mental health services, avoiding the need to commence the emergency powers.

In reaching their decision to remove the provisions, the Government have listened to stakeholders and to Parliament. Three parliamentary committees have recommended that we take this step. The Joint Committee on Human Rights report on the Government’s response to Covid argued that the need to maintain robust safeguards for patients detained under the Mental Health Act was heightened, and cautioned that if we enacted the provisions they would weaken the protections available. The Women and Equalities Committee noted concern that the provisions went against the direction of travel towards reform of the Mental Health Act, to

“a more balanced system with more safeguards, more choice and less restriction”,

as set out in the independent review of the Mental Health Act 1983. Further, the Public Administration and Constitutional Affairs Committee report on the Government’s response to Covid and the Coronavirus Act noted the concerns of the mental health charity Mind and its call for the removal of these temporary powers.

The decision to expire these provisions has been positively received by a wide range of stakeholders—including the Law Society and Rethink Mental Illness, which said that the decision came as a relief to many people living with mental illness and their loved ones—and by the House of Commons.

The Secretary of State was not persuaded, even during the initial Covid peak, that switching these powers on was necessary because our mental health services have shown incredible strength and ingenuity, for which I express immense gratitude to NHS staff. These powers are no longer required, and these regulations seek to expire them.

I will take a moment to briefly remind noble Lords about the contents of the provisions that these regulations seek to expire. The provisions would have enabled an approved mental health professional to apply to detain an individual under the Mental Health Act following the advice of one registered medical practitioner, where securing two recommendations was considered impractical or would have led to undesirable delay. The provisions would also have allowed for an extension of the time that hospital in-patients could be temporarily detained, pending an application for longer detention under the Mental Health Act.

For those in contact with the criminal justice system who have a mental illness, the provisions in the Act would have extended the amount of time a person can be remanded to hospital, allowed an accused or convicted person to be sent to hospital on the recommendation of just one registered medical practitioner rather than two, and extended the procedural time limits for transferring a prisoner to hospital.

Since the Coronavirus Act was enacted, the Government have remained committed to keeping all its aspects under close review and have stated that any provisions no longer necessary will be sunsetted. The Act will expire in its entirety two years after the date it was passed, but also contains a power allowing for the expiry of some provisions to be brought forward ahead of that time. It should be noted that these regulations will not expire the transitional provisions within Schedule 8 to the Act; however, those will have no legal or practical effect.

The Mental Health Act 1983 applies to both England and Wales. The application of the regulations differs for each country. I will therefore seek to clarify their effect on Wales. First, those easements which relate to health services in Wales will remain available to Wales. Health is a matter devolved to the Welsh Government. But, secondly, those easements concerning the operation of justice under the Act—that is, for patients under sentence or subject to criminal proceedings—will be removed for both England and Wales. These remain matters reserved to Her Majesty’s Government. With the exception of provisions relating to the Welsh mental health review tribunal, none of these provisions has been commenced. Should it ever be deemed necessary to return to these provisions, the Government will seek to introduce new legislation.

I thank the staff of NHS mental health services, who have coped without the need to turn on these emergency powers through their hard work, supported by the department and NHS England and NHS Improvement and through innovative approaches. I beg to move.

--- Later in debate ---

[Lord Bethell (Con)]

My Lords, I thank noble Lords for a thoughtful and at times very generous debate, for which I am enormously grateful. I thank the noble Lord, Lord Davies of Brixton, for a remarkable maiden speech and offer him a sincere welcome. He laid out his stall very clearly, first as a man of numbers—as many have noted, the debates of the House of Lords benefit from those who are numerate and articulate with numbers as well as words—secondly, as a supporter of the trade union movement, and I look forward to his interventions as a trade unionist; and thirdly, as a man of compassion. He spoke movingly about mental health and the provisions in these regulations, and has marked himself out as someone who I hope will make an important contribution to our health debates—he will be extremely welcome indeed.

We are aware that many people are facing unprecedented strains due to the pandemic and the measures to contain it. The mental health of everyone is absolutely critical in these unprecedented times. We know that some people will experience exacerbated mental health problems as a result of the pandemic, as has been noted by the noble Baroness, Lady Barker. Moreover, people with existing mental health conditions and front-line workers are particularly susceptible.

The noble Baroness, Lady Tyler, noted that self-reporting has gone up. Public Health England’s Covid-19 mental health and well-being report concluded that the UK population’s self-reported mental health and well-being worsened during the pandemic. The largest decline was in April 2020.

Average levels of mental distress have been reported as going up, as the noble Baroness, Lady Fox, noted, although by 8.1% measured by GHQ 12, not the high levels that some noble Lords have referred to, indicating an increase in the severity of mental health problems overall. A robust follow-up survey from July 2020 of children and young people aged five to 16 who were interviewed for the national mental health prevalence survey in 2017 suggests that rates of probable mental health disorder have increased from one in nine in 2017 to one in six in July 2020—a very regrettable development.

We understand that there is increasing evidence of significant mental health consequences for people who have contracted Covid and evidence that Covid itself impacts the central nervous system, which can affect mental health and well-being. Survivors of Covid appear to be at increased risk of psychiatric disorder. For patients with no previous psychiatric history, a diagnosis of Covid was associated with increased incidence of a first psychiatric diagnosis in the following 14 to 90 days, compared with six other healthcare events.

I reassure all noble Lords who have spoken that mental health continues to be a priority for this Government. We are doing our utmost to ensure that our mental health services are there for everyone who needs them during the pandemic. I reassure the noble Lord, Lord Blunkett, that that is why in today’s spending review the Government have announced £500 million more for mental health support for new specialist services for children and young people, plus extra assistance for people with severe mental health illnesses and faster help for those afflicted by depression and anxiety.

The well-being and mental health support plan for Covid-19 published this week is a demonstration of the Government’s firm commitment to support the mental health of everyone throughout this winter and beyond. It outlines the support available to people over the coming winter. This is just one element of our work to deliver a modern mental health service and meet the demands created by the pandemic. We have announced two new commitments to support individuals: first, a winter discharge support package backed by £50 million, which will boost capacity and support good-quality discharge from mental health in-patient settings to help reduce pressures on in-patient beds and keep patients safe over the winter. Secondly, we are taking action to support the physical health of individuals with serious mental illnesses this winter, including support for systems to deliver local, system-level tailored engagement with patients and to develop national thought leadership on outreach.

We are absolutely committed to continuing our investment in expanding and transforming mental health services in England. This will amount to an additional £2.3 billion of extra funding a year on mental health services by 2023 to 2024. I reassure the noble Lord, Lord Hunt, that we are taking a range of steps to support mental health services to be able to manage pressure over the winter period.

Above all, it is essential that the message is heard loud and clear across the country that NHS mental health services remain open for business and will be available throughout the winter. The earlier people receive support on their mental health, the more likely they are to benefit. However, in April this year, only 57,000 referrals were made, compared to 133,000 in April 2019. While figures for more recent months show that referral rates are recovering, they are significantly below last year’s. To help address this, last week we launched a new phase of our NHS Help Us, Help You campaign to encourage anyone suffering from anxiety, depression or other issues.

We will continue to make sure that mental health services, including hospitals providing in-patient treatment get equal access to PPE. All health and social care staff can access priority testing when they show symptoms, including those providing mental health services in hospitals. NHS staff without symptoms can also be tested at the discretion of their NHS trust. Hospitals can test patients, including those admitted with mental health conditions, even if there is a higher prevalence of Covid-19 in their area.

GP surgeries have been requested by NHS England to make improvements to ensure that the physical health of those living with severe mental illness is protected this winter. This includes asking practices to identify people with severe mental illnesses who are clinically vulnerable and offering those people comprehensive physical health checks and follow-up interventions, free flu vaccines to those eligible and a care plan review as appropriate.

The NHS has worked hard to keep mental health services going during the first peak, using technology where needed, but also face-to-face appointments where appropriate. All mental health trusts have established 24/7 urgent mental health helplines, where people experiencing a mental health crisis can access support and advice. In addition, we have provided £10.2 million of extra funding to support mental health charities, including the Samaritans and the Campaign Against Living Miserably.

Talking therapies will continue to be made available remotely, so that people can access help safely from home. The NHS will work to ensure that the option of face-to-face support, quite rightly alluded to by the noble Baroness, Lady Barker, and the noble Lord, Lord Walney, is provided to people with serious mental health illnesses where it is clinically safe to do so.

Public Health England has published its surveillance tracker to monitor the impact of Covid-19 on the population’s mental health. This is a proactive step which will help to ensure that our response to the effects of Covid-19 on mental health and well-being is shaped by emerging data.

The Government have committed more than £400 million over the next four years to refurbish mental health facilities, getting rid of dormitories in mental health locations and benefiting the patients of 40 trusts across the country. We are committed to supporting our staff and investing in the workforce. NHS England and NHS Improvement are also investing £15 million to ensure that all staff get rapid access to expanded mental health services. Staff who are referred will be assessed rapidly, will be treated by local mental health specialists and, where appropriate, will be referred to specialist centres of excellence.

A number of noble Lords, including the noble Lord, Lord Davies, and the noble Baroness, Lady Tyler, asked about Sir Simon Wessely’s independent review of the Mental Health Act. I reassure noble Lords that work is well under way to respond to the review, and we will publish our White Paper in due course. This will pave the way for far-reaching reforms to the legislation and practice, strengthening the rights of patients and upholding the principles of dignity, autonomy and choice, which were enshrined in the review’s recommendations.

Since the Coronavirus Act was introduced, the Government have remained committed to keeping all elements of it under close review and to sunset any provisions that are no longer needed. As I set out earlier, the emergency modifications to the Mental Health Act made by the Coronavirus Act were designed to protect patients by supporting services to be able to continue if unprecedented constraints in the mental health sector put patients’ safety at risk during the pandemic. These provisions were only ever to be used as a backstop, as I told the Committee earlier.

The noble Lord, Lord Blunkett, referred to the very moving speech of the noble Baroness, Lady Grey-Thompson. I remember her words extremely well. Decisions, over which we have no control whatever, about our uselessness will be taken by someone else in the next few months. I am very pleased that the provisions have not been switched on. I reassure noble Lords that at all times the Government have remained conscious of the need to balance those provisions against the rights of individuals detained under the Mental Health Act.

Those provisions have not needed to be switched on due to the adaptations that have been made because of the resilience and commitment of NHS staff. As a result, we believe that now is the right time to remove them so that it is clear to patients, carers, staff and stakeholders that they will not be used. The approval of these regulations by this House to remove these emergency provisions is an important milestone on the journey towards much-needed reforms to the Mental Health Act. These reforms—

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

The Division Bell is ringing. I wonder whether the Minister is coming to the end of his remarks.

[Lord Bethell (Con)]

I am.

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

If the Minister would like to finish, I will then adjourn the Committee and there will be plenty of time for noble Lords to vote.

[Lord Bethell (Con)]

These reforms, which will see that patients have greater autonomy and control over their care and treatment, will be set out in the Government’s forthcoming White Paper on this subject.

Motion agreed.

Face-to-Face Medical Appointments

Lord Bethell Excerpts

Thursday 19th November 2020 Lords Chamber

[Lord Balfe]

To ask Her Majesty’s Government what progress they have made towards the return to face to face appointments on demand for medical patients.

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

My Lords, face-to-face GP appointments increased from 10 million in August to 15 million in September. I should like to take this moment to thank those who have worked hard to restart primary care and serve patients in difficult circumstances. But I should also flag that the proportion of consultations by phone and video is currently running at around 40% and, for many people, this represents a safe, convenient, low-stress, low-cost and hygienic way to get the clinical engagement they need.

[Lord Balfe (Con)]

My Lords, I thank the Minister for his response and note that public trust in the Government is not rising at the moment, and that many people feel that the absence of effort to get medical practice back to normal is a contributory factor in this. Will the department make it a priority to get face-to-face appointments back to the level that they were before? If it cannot, the Government will find that trust declines even further.

[Lord Bethell (Con)]

My Lords, I thank my noble friend for his comments and reassure him that the Government are absolutely focused on the restart programme. The chief executive of the NHS has written to GPs, emphasising the absolute and primary importance of face-to-face appointments, for exactly the reasons that my noble friend knows full well. I also emphasise the enormous response that we have had from the public, and that we are meeting exacting targets for those face-to-face meetings. I also emphasise that new technologies and techniques have been very much welcomed by the public. Telemedicine, and telephone and video consultations, have proved to be extremely popular and helped to increase the number of appointments last month compared with this time last year.

[Lord Harris of Haringey (Lab)]

My Lords, nearly three-quarters of GP consultations at the peak of the pandemic were conducted by telephone or video call. A BMA survey in June found that nine in 10 GPs want to continue to deliver consultations remotely, once the pandemic has ended. Many people are reluctant to discuss their symptoms in this way, or cannot access the necessary technology, and often diagnoses are not possible without a physical examination. Is the Minister happy with such a change? What guidance does the department intend to give on this, and will the GP contract be reviewed to reflect what is happening?

[Lord Bethell (Con)]

The noble Lord is entirely right. Without doubt, there are very many circumstances in which a face-to-face appointment is absolutely necessary, whether that is for a physical analysis, for the comfort of the patient or to check out other symptoms that may not be apparent from a telephone call. However, there are other people for whom telephone appointments are helpful. The Royal College of Physicians found that 20% of patients over 65 felt worse after an in-person appointment because of the stress involved. But the noble Lord is entirely right that guidelines do need to be evolved in order to reflect the changes, and there may be a moment when the GP contract needs to be revisited.

[Lord Mann (Non-Afl)]

Iceland has better survival rates for strokes by using telemedicine for decisions in acute care on thrombolysis. Will the Government not take this opportunity to move primary care far more into the modern era by encouraging a far greater use of telemedicine, and not simply hark back to the past as we learn from the experiences of Covid?

[Lord Bethell (Con)]

The noble Lord makes an incredibly interesting parallel with Iceland. It is not one that I knew, but I will take care to look into it, because it is instructive and informative. He is right to say that Covid has demonstrated the power of telemedicine, and we are keen to learn that lesson. We do not want the elastic band of old practice to snap back to where it was before. To reflect the words of a noble Lord who spoke previously, there will be occasions when tele- medicine is right. The key is getting the blend correct and ensuring that the right format is used in the right circumstances.

[Baroness Browning (Con) [V]]

I quite accept that there is a role for telemedicine, but an accurate diagnosis in cases of serious disease and illness is dependent not just on the questions that the doctor asks and the observations he makes but on the ability of the patient to give accurate information. I will give the example from my family in the past few months of antibiotics prescribed for a “lung infection” that was actually a fatal pulmonary embolism. Getting that mix right is not easy; there are very many shades of grey.

[Lord Bethell (Con)]

My noble friend makes a very good point. Diagnosis is phenomenally difficult and, quite often, patients who present with seemingly one condition have something altogether different. It may be that a face-to-face appointment will be the moment when that difference is spotted and caught. She is entirely right to say that we cannot omit that format for the right circumstances, but a great many patients see their GPs very regularly. Their journeys may be onerous, uncomfortable and stressful, and telemedicine might offer them an alternative opportunity. There are others for whom speed is of the essence, and having telemedicine, particularly when it is supported by apps that provide essential information about their condition, can be an important and urgent alternative.

[Baroness Tyler of Enfield (LD) [V]]

My Lords, according to the June edition of the British Medical Journal, the biggest change for mental health services has been the rapid adoption of video and phone consultations, an approach that had rarely been used in a field where relationships and trust between clinicians and patients are vital and where body language and eye contact are often a key part of the assessment. Many in the sector have reported that virtual appointments are at best inferior, particularly with young people, those with learning disabilities and the elderly. What assurances can the Minister give that face-to-face appointments will continue to be made available for those who need them in this field?

[Lord Bethell (Con)]

The noble Baroness has raised an important point. I saw the BMJ article to which she has referred; it was a very interesting warning shot, whereby we should not overshoot in this area. But perhaps I can also emphasise that other interesting evidence shows that some mental health services have been better provided by online consultations. For instance, some young people do not like visiting clinics, where they feel uncomfortable, and prefer video conferences. I think it is too early to call it on this one, because we need to analyse closely the benefits and disbenefits in the area of mental health. We must ensure that we have the right format for the right occasion, but I completely take on board the warnings of the noble Baroness.

[Lord Flight (Con)]

My Lords, my personal experience of online doctor appointments is that they are most satisfactory, efficient and time-saving, but I do understand that many older citizens may want and often need to have traditional face-to-face appointments. Appointments on demand are surely not practical, but does the Minister support citizens having the legal right to request one-to-one doctor appointments?

[Lord Bethell (Con)]

I agree with my noble friend that the terms of service should be clear, although I am not sure that we necessarily have the scope for or benefits of a legal right per se. However, perhaps I may disagree with him on one point. He said that there is a greater demand among older citizens for face-to-face contact, but that is not our experience. Older citizens are often very engaged digitally, prefer to engage with their clinicians, on occasion, from the comfort of their own homes, and can often be early adopters of such technologies.

[Baroness Meacher (CB) [V]]

My Lords, I agree with the Minister that, much to doctors’ surprise, many older people prefer to have virtual appointments, whether by Zoom or telephone. We can make assumptions about people, but doctors have been quite surprised by the extent to which patients prefer having an online consultation. Does the Minister agree that, in the end, this needs to be a matter for doctors to decide? Very often, they will have an initial conversation and then agree to see the patient when that is necessary. However, this is probably not a matter for government to decide on or to intervene in, and certainly not until doctors have settled down to a pattern of consultations based on their experience and understanding of their patients.

[Lord Bethell (Con)]

The noble Baroness makes a good point, but I would put a slightly different perspective on it. Doctors have not been the most progressive group in this area; as she says, they have been caught by surprise by patients’ views. I would actually give patients the loudest voice in this particular conversation.

[The Deputy Speaker (The Earl of Kinnoull) (Non-Afl)]

My Lords, I regret that the time allotted for this Question has now elapsed.

Brain Tumour Research

Lord Bethell Excerpts

Thursday 19th November 2020 Lords Chamber

[Lord O’Shaughnessy]

To ask Her Majesty’s Government what financial support they are providing for research into therapies and treatments for people with brain tumours.

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

My Lords, in 2018, the Government announced funding of £40 million over five years for brain tumour research as part of the Tessa Jowell Brain Cancer Mission, through the NIHR. We are relying on researchers to submit high-quality research proposals in this very difficult area. To encourage such applications, in April 2018 we released an NIHR highlight notice on brain tumour research asking research teams to submit collaborative applications, building on recent initiatives and investments.

[Lord O’Shaughnessy (Con)]

I am grateful to my noble friend for that Answer. Nearly three years ago, this House was witness to one of the most courageous and moving speeches in its long history when Baroness Jowell argued for better support for people who, sadly, like her, die from rare cancers. We have made progress since then; fluorescent dye to aid surgical accuracy has been rolled out and new specialist brain cancer centres have been set up across the NHS. However, funding for research is lagging. Of that £40 million promised by the NIHR, only £6 million has been allocated. Can my noble friend tell the House what the department is doing to address this issue and is he prepared to meet with representatives of the brain cancer research charities in order to think of a way forward?

[Lord Bethell (Con)]

My Lords, the memory of Baroness Tessa Jowell has had a huge impact in this area. I remember well her testimony from these Benches and the mood of the House then. It was an extremely moving and impactful occasion and we remember her very fondly indeed.

My noble friend is entirely right that it is extremely frustrating that not more of this money has been spent. You will not catch me saying that very often at the Dispatch Box, but in this case, it is true. Managing the pipeline of research submissions through the process to the NIHR is a challenge. The NIHR has very high standards for the allocation of research grants and to date, it has struggled to find the number and quality of grants to support. That is why we will put a renewed focus on supporting the drafting of better grants, and I would be pleased to meet with the charities recommended by my noble friend in order to discuss the ways we can do that.

[Baroness Ritchie of Downpatrick (Non-Afl) [V]]

My Lords, I have been told that only 5% of national spend on cancer research is devoted to brain tumour research. Let us consider the collaborative work being undertaken on precision medicine by the University of Bristol and Queen’s University Belfast. What additional funding could be dedicated to this area, which provides individualised treatments to ensure better patient outcomes?

[Lord Bethell (Con)]

The noble Baroness is entirely right that precision medicine offers an enormous and powerful opportunity for us to tackle cancers. Brain cancers are particularly difficult to tackle, especially in adults, and we are daunted by the struggle to make further progress in this area. Since April 2018, we have spent £5.7 million on directly funded brain tumour research, but that is not enough and we would like to spend more. I am open to recommendations on how the money could be spent.

[Baroness Morgan of Cotes (Con) [V]]

My Lords, brain tumours kill more children and adults under the age of 40 than any other cancer, and I am grateful to hear my noble friend’s acknowledgement that research funding is not yet enough. Does he agree with the proposal to change the system so that if a site-specific brain tumour grant is deemed fundable by a panel, it will automatically be funded during a highlighted brain tumour funding round such as the one announced last month?

[Lord Bethell (Con)]

My Lords, I am extremely grateful for a briefing given by Professor Richard Gilbertson earlier today on the specific question raised by my noble friend, which is grants for brain tumours in children. The NIHR system is a gold standard that is envied by the world and does not necessarily need to be broken and restarted. However, the point made by my noble friend is a good one and we are looking at ways of ensuring that more and better recommendations for grants go into the system in the first place so that, basically, we can spend the money more quickly.

[Lord Carlile of Berriew (CB) [V]]

My Lords, on 6 November this year, the Government spoke of developing quality research and funding through a successful partnership and sustainable alignment with the charity sector. When can we expect to see some results from that initiative, with work and funding to achieve those goals?

[Lord Bethell (Con)]

My Lords, the work of the charity sector in medical research is absolutely fundamental to national progress in this area. However, it too has been hit incredibly hard by Covid. We are having a number of dialogues with medical research sector representatives on how we can help. There will need to be a short, medium and long-term approach to getting back to where we were at the beginning of the year. How we bridge the current funding gap is a source of enormous concern to the department and the NHS. I cannot guarantee that we can necessarily embark on exactly the same framework that we envisaged at the beginning of the year, but I can reassure the noble Lord that we are very committed to the research community and we engage with it regularly on how we can help.

[Lord Reid of Cardowan (Lab)]

My Lords, several references have been made to our late and much-loved colleague Tessa Jowell, who I was proud to call a friend. Was she not prescient when in her last speech to this Chamber she said:

“I am not afraid. I am fearful that this new and important approach”—


referring to research—

“may be put into the ‘too difficult’ box”. [Official Report, 25/1/18; col. 1170]

When the Minister tells us in all sincerity that it is just too difficult to spend the £40 million that was promised, will he at least give this House an assurance that after this discussion he will take a personal and direct oversight of this matter, because it would be a great tragedy if those words of Tessa Jowell proved to be correct in the long run?

[Lord Bethell (Con)]

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

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

[Baroness Jolly (LD) [V]]

My Lords, the noble Lord, Lord Reid, referred to Baroness Jowell’s final speech, when she told us not to give up fighting this pernicious cancer. The noble Lord, Lord O’Shaughnessy, the then Minister, gave the assurance that the Government would not cease support for research into new treatments. Can the Minister confirm how many more research programmes into brain tumour treatments and therapies have been funded by NIHR since then? Is he confident that enough is being done?

[Lord Bethell (Con)]

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

[Lord Polak (Con)]

I, too, was privileged to be present when Baroness Jowell spoke. In 1988, a 27 year-old man whose wife was eight months pregnant and who had just completed the London Marathon, was told by a neurologist that he had a brain tumour and six months to live. My Lords, that young man was me. I thank God and the doctors and nurses at the Royal Free Hospital that I am here to tell this story.

What is being done to educate and work with families and loved ones, who take the brunt of providing support for the patient and who most likely have no medical knowledge? While the Minister will be aware that not all brain tumours are cancerous, can he explain the Government’s commitment to fighting this niche but deadly form of cancer?

[Lord Bethell (Con)]

My Lords, on behalf of everyone, I thank my noble friend for that powerful personal testimony. I am sure there will be many others in the Chamber or listening who have known or lived through some association with brain cancer or cancer of some kind. It is extremely gratifying that in many areas of cancer we have made enormous progress—to the extent that it is a completely treatable disease in many respects—but in the area of brain cancer, that is not true. That is not good enough and we are working on trying to find a solution. Money has been spent, but not enough. We need more focus on this.

On my noble friend’s point on supporting families, that is something that trusts work on, but it is left to the charities and support organisations to do. In all areas of illness, that is something where perhaps we could or should be doing more and I completely take on board his comments.

[The Deputy Speaker (The Earl of Kinnoull) (Non-Afl)]

The time allowed for this Question has elapsed.

Personal Protective Equipment: Procurement

Lord Bethell Excerpts

Thursday 19th November 2020 Lords Chamber

[Baroness Hayter of Kentish Town]

To ask Her Majesty’s Government whether they will (1) outline the transparency and reporting requirements of the procurement of personal protective equipment, (2) detail the steps taken to register any potential conflicts of interest in that process, and (3) publish all information about any such contracts awarded, including payments for intermediaries; and if not, why not.

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

My Lords, the National Audit Office report on Covid-19 procurement activity, published yesterday, recognised how we needed to procure new PPE contracts with extreme urgency in order to save lives. We are committed to publishing all the information about these contracts. Robust due diligence processes were in place. The report makes clear that there were no conflict-of-interest issues in procurement decisions. We will respond to the report’s recommendations in due course.

[Baroness Hayter of Kentish Town (Lab)]

My Lords, I am surprised by the Minister’s reply. The NAO report revealed numerous issues of concern, from lobbying by an adviser to Liz Truss for a transaction in which he had an interest to the creation of a VIP fast track which happened to assist those with connections to senior Conservatives. Some awards were made without tender; some had no written contracts. There was no documented proof of urgency, nor of how to handle conflicts of interest. Awards were made to a pest control firm and £250,000 went to a jewellery company with no PPE experience. Today, we learn of a cannabis research firm with just £6,000 in assets being handed PPE contracts of £33 million.

The Minister has helpfully tweeted that he is going to respond by saying how well people did in responding to the Covid crisis. That is no excuse for improper dealing. Will the Minister say not only that these details will be published but that I and other Members of this House will get that list soon, as the information should have been published within 30 days of the contracts being signed?

[Lord Bethell (Con)]

I am grateful to the noble Baroness for this opportunity. We take transparency extremely seriously. We share the same values about doing things in the proper way. I stress “the proper way”. The NAO report does not say that the way in which the pandemic was responded to was “improper”, as she suggested. In many ways, the report is supportive of the point that we were facing an unprecedented global pandemic that posed a massive challenge to the entire country. We needed to procure contracts with extreme urgency in order to secure vital supplies. The shadow Health Secretary called on the Government to “move heaven and earth” to get needed PPE to staff. The leader of the Opposition quite rightly called on the Government to get rid of blockages in the system, saying:

“The Government must act to ensure supplies are delivered.”


We did everything we could to do that and I am proud of the achievement of those involved.

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

The noble Baroness, Lady Jolly, has withdrawn, so I call the noble Lord, Lord Balfe.

[Lord Balfe (Con)]

My Lords, the report does not make for happy reading, to put it mildly. There is a perception that the reality is some way away from where the Minister thinks it is. That may be fanned by the press, but the image of a tawdry chumocracy is to the fore in many newspaper reports. There were five recommendations in this report, all of which would benefit from the disinfectant of sunlight. My question to the Minister is quite simple: will the Government accept, implement and investigate the five recommendations?

[Lord Bethell (Con)]

My Lords, I encourage my noble friend to look beyond newspaper reports. The reality is—

[Lord Balfe (Con)]

No, it is in the report.

[Lord Bethell (Con)]

I ask my noble friend to look beyond newspapers for his analysis of the report. I take the five recommendations very seriously. They are encouraging and ally absolutely with the Government’s values. We will look at how to implement them in due course.

[Lord Berkeley of Knighton (CB) [V]]

My Lords, I listened yesterday to the Minister’s response to a similar Question. I accept that Governments were under an incredible strain, but many were better positioned and prepared than we were. Does the Minister have any regrets to which he will own up about the way in which money was handed out to procure PPE?

[Lord Bethell (Con)]

I have to be careful about what I say because legal proceedings are in place. The noble Lord is right; I do not pretend for a moment that everything was perfect. I have spoken quite candidly—possibly more candidly than I should have—about the challenges that we faced. Not everything was perfect or ran smoothly, and no well-honed machine sprang into life. However, I am proud that we reacted with energy, skill and elan. We made the most of a very difficult and unprecedented situation. I cannot hide my gratitude to those who stood up to help. Offers of help came from all sorts of places. We should be cheering them and not in any way attacking them.

[Lord Triesman (Lab) [V]]

My Lords, I declare my interests as in the register. I welcome the fact that the Minister intends to publish this information. I urge him to do so as rapidly as possible, as my noble friend Lady Hayter has suggested. Perhaps we could refine what sort of information would be desirable. Will the Minister ensure that the names of each of the 144 companies that the National Audit Office says were introduced to the VIP channel by Ministers’ private offices are published? Who authorised their acceptance into that channel? Who are the ultimate beneficial owners of those companies? This is critical. Which Minister made the introduction in each case?

[Lord Bethell (Con)]

The noble Lord, Lord Triesman, misconstrues the nature of events. The Prime Minister made a number of public calls for help, which resulted in more than 15,000 offers. Of course, those had to be triaged. Not all were credible. Some were helpful and some were well-intentioned but not all were practical. We had to find a way of prioritising the most impactful. Anyone in our position would have done the same. This credible list included senior professional healthcare clinicians; members of former Governments of all parties; leaders of British industry; and all manner of helpful people, some of whom came from completely unexpected places. I should be happy to tell the stories of some of those unexpected offers another time. The noble Lord’s description of the prioritised channel is a misrepresentation. I regret that I cannot proceed as he asks.

[Lord Scriven (LD)]

My Lords, let us be clear. The issue is not that people stood up; it is what the Government then did to procure goods and services. Yesterday’s National Audit Office report states

“we cannot give assurance that government … mitigated the increased risks … or applied appropriate commercial practices”

at all times. That is technical-speak for not being able to rule out fraud or corruption. How can the Minister stand at the Dispatch Box and say with any credibility that all the rules were carried out and there were no conflicts of interest? Which should we believe, a line from the Dispatch Box or a report from the National Audit Office?

[Lord Bethell (Con)]

My Lords, I do not really recognise the noble Lord’s technical-speak interpretation of the NAO report. In fact, the report is crystal clear. Yesterday, I quoted from its references to Ministers and conflicts of interest, and I do not think that I need to repeat it: it was crystal clear. However, perhaps I may reassure the noble Lord. I do not pretend for a moment that every single piece of paperwork got done on time during the pandemic—quite the opposite. We rewrote the guidelines on 18 March and reissued them: there is no way that you can jump through the hoops of a normal tendering process when you are in the middle of a massive global land grab. I am not pretending that; I am saying that there were not conflicts of interest, that Ministers were not involved in the procurement decisions and that the nation should be proud of the way in which we responded to the pandemic.

[Lord Marlesford (Con) [V]]

My Lords, what taxpayers will really want is a list of the Covid contracts that went wrong, either because the goods and services were not delivered or because they were not up to standard. They will want to know, in each case, the value of the contract, the amount of public money paid to the contractor, the amount reclaimed by the Government because of failure and the amount recovered for the taxpayer. Will my noble friend agree to produce such a list—eventually, at least—and put it in the Library of the House so that everybody can see it?

[Lord Bethell (Con)]

I entirely agree with my noble friend. Such lists will be published. Eighty-nine per cent of the contract award notices have already been published under the Official Journal of the EU; I would be glad to send my noble friend a link.

[Lord Alton of Liverpool (CB) [V]]

My Lords, in a Written Answer, the Minister confirmed to me that the NHS warehouse for PPE at Daventry has masks made by Medwell Medical Products. It is estimated that a quarter of the workers at its Chinese factory are Uighurs in a facility 3,444 kilometres from Xinjiang, so it is implausible that they went there voluntarily. In his Answer, why did the Minister not name the intermediary company involved? Will he now say whether it was Meheco or another state-owned company, what the value of the deal was, whether our embassy was involved, whether the UK made the deal before or after July—when Medwell was named in reports—and what steps he is taking to ensure that the United Kingdom is not complicit in using Uighur slave labour to produce PPE for the NHS and profits for the Chinese Communist Party?

[Lord Bethell (Con)]

My Lords, I acknowledge the extremely good work that the noble Lord does on this issue. Of course, no one wants to see Uighur slave labour used to produce PPE for the NHS. On his specific questions, I do not have the details to hand, but I am happy to revisit the Written Answer that I gave him to see whether I can provide any further details.

[Lord West of Spithead (Lab)]

My Lords, this issue and the report fill me with despair, I must say, as does the fact that it appears that the Government took action almost in a panic. Yes, horrible things happen but Governments should not panic, and there are rules, which should be followed. One could understand an individual who is ill informed and not well educated grabbing a supermarket trolley and filling it with loo rolls, but that is not how Governments should act. There are very clear ways of behaving. When I was in Whitehall and wanted to procure things, I had to go through several hoops. Civil Service rules and the law demanded it, and the fact that we had to do things quickly was not an excuse. Post all this, will we check that Civil Service rules were complied with and that the correct actions were taken that did not break any laws of the land?

[Lord Bethell (Con)]

I am always grateful for advice from the Ministry of Defence on procurement, which it always manages extremely well. With regard to the work of civil servants, the report speaks for itself. That is the exact purpose of the report.

[The Earl of Shrewsbury (Con)]

My Lords, is my noble friend aware of a BBC Midlands TV news report earlier this week of a recent meeting at University Hospitals Birmingham NHS Foundation Trust regarding procurement? Those attending that meeting were informed that the DHSC had ceased funding the purchase of PPE by regional NHS trusts and that those trusts would have to purchase PPE directly from NHS Improvement. Further, is he aware that such a decision greatly affects a successful and efficient manufacturer of some 10,000 PPE gowns a week called Wearwell, based in Tamworth, Staffordshire? It will no longer be able to supply the local NHS trust, by which it is recognised and approved as a supplier, as it is not recognised and approved as such by the NHS national framework. Is that situation not completely ridiculous? Will he look into the matter urgently and perhaps write to me?

[Lord Bethell (Con)]

I am extremely grateful to my noble friend for giving me advance notice of his question. I am aware of the changes in procurement practices in the NHS, which I welcome. They will have a huge impact and protect us in the case of future pandemics. I am also aware of the phenomenal effort by British manufacturers, which have stepped up to the challenge of producing PPE and have, in my view, gone a lot further than anyone expected, producing around 50% of the NHS’s PPE. There have clearly been unintended consequences if this company, Wearwell, has somehow fallen off the procurement list. I would be happy to take a letter from my noble friend and look into the matter.

[Baroness Bennett of Manor Castle (GP) [V]]

My Lords, public trust has clearly been lost over PPE procurement and the NAO report. What do the Government plan to do to restore it?

[Lord Bethell (Con)]

My Lords, I simply do not accept the assumption of that question. I think that the public see a Government who stepped up to an enormous challenge and did their best under very difficult circumstances. Many of the public individually stood up as volunteers and many professionals returned to former jobs to help out. Many businesspeople turned over their capacity, their staff or their focus to help out in the pandemic, and the Government took on a huge amount of support from members of the public. These sweeping assumptions that somehow everything was done in a negative way are very unhelpful and in fact do not chime with the mood of the public at all.

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

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

Medicines and Medical Devices Bill

Lord Bethell Excerpts

Committee stage & Committee: 7th sitting (Hansard) & Committee: 7th sitting (Hansard): House of Lords
Thursday 19th November 2020 Grand Committee

[Baroness Thornton (Lab)]

My Lords, I will be very brief, as it must be clear to the Minister that there is unanimity across the Committee in support of setting up this safer care task force. My noble friend Lord Hunt was quite right that this is about whether the Government take this report seriously, and for me this is also an issue of accountability. Recommendation 9 of nine states:

“The Government should immediately set up a task force to implement this Review’s recommendations.”


I hope that the Minister will just say, “Yes, we’ve done it”, so that we can now be told what the timeline for the task force will be and who will be involved. That is my hope from the Minister’s remarks, but if that is not to be the case, I hope that it might be the case in two or three weeks’ time when we move to the next stage of the Bill.

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

My Lords, again, I thank my noble friend and her team for their work to produce the report and to ensure that patients and their families have been heard. Above all, I pay tribute to all the patients and their families who have so bravely shared their experiences to inform this important report. The report has been impactful and has already served to firmly put patient safety at the top of the agenda for all the healthcare system, and we in the Government are committed to learning from it.

On the amendment, if I may put this delicately, we must please remember that this is not a Bill to respond to the review. The Bill provides the powers needed to be able to update the current regulatory regime for medicines, devices and clinical trials in response to the end of the transition period, although the Bill does have the best interests of patients at its heart.

If it was not for the ongoing impact of Covid-19 on the health and care system, I believe that we would be discussing little else but patient safety. But, as my noble friend Lady Cumberlege has acknowledged in this Grand Committee, Covid has had a challenging impact on all our priorities, including on her own work on the NHS maternity transformation programme —and, of course, on the publication of her report, which was scheduled for the beginning of this year but, because of Covid, happened only 16 weeks ago.

I can assure noble Lords that much activity is already under way. Officials from across the healthcare system have been working together intensely since the report’s publication. They have been meeting weekly since August to ensure that we fully understand the report’s recommendations and the best way forward.

My noble friend has rightly mentioned the importance of listening to and involving patients in the implementation process. We absolutely recognise the need for effective patient engagement to ensure that we get implementation right. The Minister of State, Nadine Dorries, will provide an update on this and other matters related to the report in December, and I shall be very happy to report likewise to this House.

These debates have been clear, and I can assure noble Lords that, as part of our consideration of the report, we will of course want to be informed by the debates on this Bill before responding in detail to this very important report. I am very sympathetic to the desire of my noble friend and others to see the Government move quickly in responding to her report, but I do not agree that this Bill is a sensible method of delivery for that response. It is a weighty report, and our response will be rightly scrutinised when the Government responds to Parliament, but an amendment in this Bill is not the right mechanism. We should not be making policy through legislation, for that rarely makes for good government policy-making.

Therefore, I hope that this is a probing amendment, seeking some reassurance, rather than a firm request. In that spirit, I welcome the opportunity to update the Grand Committee on some of the progress that we are making to date.

Recommendation 1 has been implemented. The Government have, on behalf of the health and care sector, apologised to those women, their children and their families for the time that the system took to listen and respond.

We debated my noble friend Lady Cumberlege’s amendment for a patient safety commissioner just a few days ago, so I shall not repeat all the points raised. It was an insightful discussion, and I will think on it further, as I said during the debate.

We shall shortly be debating Amendments 122 and 123, on establishing a redress agency and redress schemes, so I will not pre-empt those discussions.

On recommendation 5, I know that my noble friend is already aware of work to establish specialist centres for mesh removal, but I would like to say a little more in recognition of its importance. NHS England is working closely with providers to set up the specialist mesh removal centres and is currently working to prepare for launch next April. The service specification for mesh centres describes how all centres must come together in a clinical summit to agree how we can develop the service moving forward, to agree standards that all centres will work to and to share data and outcomes. The first summit will take place tomorrow, 20 November. I am pleased to note that clinicians from the devolved nations are invited to that session too.

On recommendation 6, the MHRA has already begun a substantial programme of work to change the culture of the agency. Key priority areas are: first, listening and responding to patients; secondly, better utilising scientific evidence to strengthen and speed up decision-making on safety; and, thirdly, becoming more open and transparent in everything that the agency does. The MHRA is strengthening its yellow card scheme to make it easier for both patients and healthcare professionals.

On recommendation 7, as my noble friend will also be aware, we have debated Clause 16 of the Bill. Significantly, its provisions will mean that, in future, we can collect surgical implants and devices data from all NHS and private provider organisations, starting with mesh-related procedures and from that agreed next steps.

On recommendation 8, the General Medical Council already has guidance covering financial and commercial arrangements and conflicts of interest, which came into effect on 22 April 2013. In addition, the GMC’s updated consent guidance came into effect on 9 November. This reaffirms that any conflicts of interest that a doctor or their organisation may have should be shared with patients where relevant. We are considering whether these arrangements should be strengthened further.

My noble friend Lord O’Shaughnessy spoke of a worrying attitude of fatalism in the system, but I should also flag the work being done by GPs, universities and the royal colleges on long Covid and the excellent work being done to protect patients. We are listening to patients, who are presenting highly complex symptoms, including mental health, renal, cardiac, respiratory and other issues. I host a weekly round table that has full engagement with representative groups. We have mobilised a whole-system response. We are linking research with guideline writing for primary care in real time. We are using data thoughtfully, and we are mobilising networks of concerned groups around the country and around the world. This reflects the priority that we have already put on the recommendations of the patient safety report.

My noble friend Lady Cumberlege and her team took two and a half years to complete their review and present their findings, and I am intensely grateful for that. It is imperative, for the sake of patients and especially those who have suffered greatly, that we give this independent report the full consideration it deserves. I look forward to updating the House following the Minister’s Statement in the other place before recess. I therefore hope that my noble friend Lady Cumberlege feels able to withdraw her amendment.

[The Deputy Chairman of Committees (Lord Brougham and Vaux) (Con)]

I do not believe that anyone wishes to come in after the Minister, so I call the noble Baroness, Lady Cumberlege.

--- Later in debate ---

[Baroness Thornton (Lab)]

I think this has been one of those really rather good and unexpectedly deep House of Lords discussions, going back into the mists of time. Until the noble Baroness, Lady Cumberlege, mentioned the redress Act, I had completely forgotten about it—it all came flooding back.

We have two quite different amendments in this group, and my noble friend Lord Hunt said at the outset that his Amendment 122 was a probing amendment. This is about opening up the discussion, which it certainly did—a discussion that has long needed resolving. The noble Lords, Lord Lansley and Lord O’Shaughnessy, were quite right in that it is an issue of the future; this group has one probing amendment about the future—what it should look like and how you create an agency that can address the issue of those harmed by medicines and medical devices. It is a very legitimate discussion, which needs to be had.

The second amendment, in the name of the noble Baroness, Lady Cumberlege, is about the future, what happens now and what happens about the harms that were done—the avoidable harms, in the case of hormone pregnancy tests, sodium valproate and pelvic mesh. That is very important indeed, and the noble Baroness is right to say that those harms must be specifically addressed by the Government and to push that. I think that is what we would be looking for—how the Government would implement those recommendations. I see the noble Baroness, and the noble Baroness, Lady Bennett, whose comments we very much welcomed and valued, but I do not think that was the last word. I hope she will involve herself in the next stage of the Bill. In fact, I am depending on it.

The Government have to address Amendment 123 in particular, because that is urgent and needs to be done now. I look forward to hearing what the Minister has to say about that in particular.

[Lord Bethell (Con)]

My Lords, I thank the noble Lord, Lord Hunt of Kings Heath, and the noble Baroness, Lady Bennett of Manor Castle—who indicated her interest in this along with my noble friend Lady Cumberlege—for raising the important issue of redress for those harmed by medicines and medical devices.

I share the review’s concern that patient voices were not heard, and I reiterate that we are committed to ensuring that the healthcare system does better at listening, learning and acting on patient concerns. Furthermore, we recognise that patients need to be at the centre of decision-making to ensure that their perspectives are built in.

Our focus is on improving the safety of medicines and medical devices so that in future there should be less need for redress. We are determined to increase patient safety and drive additional pre-market scrutiny and post-market surveillance of medical devices. For example, the yellow card scheme plays a vital role in providing an early warning that the safety of a product may require further investigation, and the MHRA is transforming and strengthening the system to make it easier for patients and healthcare professionals in the UK to directly report adverse incidents involving all medicines and medical devices. The UK has one of the safest medicines systems in the world and we will continue to make sure that patients and the public have access to the best and most innovative medicines.

Amendment 122, in the name of the noble Lord, Lord Hunt, would require the Secretary of State to bring forward proposals to establish a redress agency within 12 months of the Royal Assent of this Bill. Committing now to such an agency would short-cut the in-depth policy consideration that the review’s recommendation of a redress agency deserves, as a number of noble Lords have reasonably recognised. I understand that my noble friend Lady Cumberlege herself undertook substantial engagement with the affected patients and other parties as part of her review. Listening and consultation is a vital part of how we take forward any policy change, and it is even more important given the significance of this issue.

A redress agency would represent a significant addition to the current landscape for all stakeholders, and we need to give them time to contribute their perspectives and think through the implications for them. In particular, there is a need to work through what the determinations and parameters of such arrangements would be and how they would interface with current legal remedies—already complex—before we could agree to take forward this proposal. This would help us explore how that would affect the patient journey through different potential approaches, the costs and their value for money. We also need to be mindful of the potential impact on industry.

With regard to Amendment 123, tabled by my noble friend Lady Cumberlege, given that legal action is pending over hormone pregnancy tests, and as is usual when matters are sub judice, I am restricted in what I can say on this aspect of the amendment.

I know that the establishment of a specific redress scheme was my noble friend’s fourth recommendation in the report of the Independent Medicines and Medical Devices Safety Review. While I am very sympathetic to the desire of my noble friend and others to see the Government respond to her report and take forward her recommendations, I do not agree that policy should be made and deadlines set through primary legislation. Indeed, her report itself was sadly delayed during the current situation we find ourselves in.

I reassure the noble Lord, Lord Hunt, that we will respond to the issues raised in the amendment as part of our formal response to the Independent Medicines and Medical Devices Safety Review. The Government are considering all recommendations made in that review and will provide an update before the Christmas Recess. I hope that the noble Lord, Lord Hunt, has heard enough that is reassuring and feels able to withdraw Amendment 122, and that my noble friend Lady Cumberlege is similarly reassured not to move hers.

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

My Lords, I have received no requests to speak after the Minister, so I call the noble Lord, Lord Hunt of Kings Heath, to conclude the debate on his amendment.

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Moved by

[Lord Bethell]

126: Clause 41, page 24, line 9, leave out “consult such persons as the authority considers appropriate” and insert “carry out a public consultation.
(1A) In relation to proposed regulations under section 16(1), the Secretary of State must specifically consult—(a) the Welsh Ministers,(b) the Scottish Ministers, and(c) the Department of Health in Northern Ireland.(1B) In relation to proposed regulations under section 1(1), 8(1) or 12(1), the consultation document must include a summary of the relevant authority’s assessment of the matters mentioned in section 1(1A) and (2), 8(1A) and (2) or 12(1A) and (2)(as the case may be).”Member’s explanatory statement
This amendment 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, as well as requiring the Secretary of State to consult the devolved administrations in relation to regulations under clause 16(1).

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Moved by

[Lord Bethell]

131: After Clause 41, insert the following new Clause—
“Reporting requirements
(1) As soon as reasonably practicable after the end of each reporting period, the Secretary of State must lay before Parliament a report on the operation of any regulations made by the Secretary of State under sections 1(1), 8(1) and 12(1) that were in force at any time during the reporting period.(2) In preparing a report, the Secretary of State must consult such persons as the Secretary of State considers appropriate.(3) A report must include a summary of—(a) any concerns raised, or proposals for change made, by a person consulted in accordance with subsection (2), and(b) the Secretary of State’s response to those concerns or proposals, including any plan the Secretary of State may have to make further regulations under section 1(1), 8(1) or 12(1).(4) The reporting periods are—(a) the period of 24 months beginning with the day on which the first set of regulations under section 1(1), 8(1) or 12(1) comes into force, and(b) each successive period of 24 months.”Member’s explanatory statement
This new Clause imposes reporting requirements on the Secretary of State in relation to the operation of regulations made under Clauses 1(1), 8(1) and 12(1).

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Moved by

[Lord Bethell]

133: Page 24, line 36, leave out subsections (3) to (9) and insert—
“(3) The procedure for making regulations under Part 1, 2 or 3 is to be determined in accordance with this table and subsection (4)—

If the regulations contain provision made in reliance on	the regulations are subject to
section 5(1)(a)	the negative procedure
section 10(1)(a)	the negative procedure
section 14(1)(a)	the negative procedure
paragraph 9 of Schedule 1	the negative procedure
section 6	(a) the made affirmative procedure, where the regulations contain a declaration that the person making them considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health
	(b) the draft affirmative procedure in any other case
section 15	(a) the made affirmative procedure, where the regulations contain a declaration that the Secretary of State considers that they need to be made urgently to protect the public from an imminent risk of serious harm to health
	(b) the draft affirmative procedure in any other case
any other provision in Part 1, 2 or 3	the draft affirmative procedure

(4) Provision that may be made by regulations subject to the negative procedure may be made by regulations subject to the draft affirmative procedure.
(5) Where regulations are subject to “the negative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations is subject to annulment in pursuance of a resolution of either House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they are subject to negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations is subject to—
(i) annulment in pursuance of a resolution of either House of Parliament, and
(ii) negative resolution within the meaning given by section 41(6) of the Interpretation Act (Northern Ireland) 1954.
(6) Where regulations are subject to the “draft affirmative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations may not be made unless a draft of the instrument has been laid before and approved by a resolution of each House of Parliament,
(b) in the case of regulations made by a Northern Ireland department acting alone, they may not be made unless a draft of the regulations has been laid before and approved by a resolution of the Northern Ireland Assembly, and
(c) in the case of regulations made by the Secretary of State and a Northern Ireland department acting jointly, the statutory instrument containing the regulations may not be made unless a draft of the instrument has been laid before and approved by a resolution of—
(i) each House of Parliament, and
(ii) the Northern Ireland Assembly.
(7) Where regulations are subject to the “made affirmative procedure”—
(a) in the case of regulations made by the Secretary of State acting alone, the statutory instrument containing the regulations—
(i) must be laid before Parliament after being made, and
(ii) ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by a resolution of each House of Parliament,
(b) in the case of regulations made by the Department of Health in Northern Ireland acting alone, they—
(i) must be laid before the Northern Ireland Assembly after being made, and
(ii) cease to have effect at the end of the period of 40 days beginning with the day on which they are made unless, during that period, the regulations are approved by a resolution of the Assembly, and
(c) in the case of regulations made by the Secretary of State and the Department of Health in Northern Ireland acting jointly, the statutory instrument containing the regulations—
(i) must be laid before Parliament and the Northern Ireland Assembly after being made, and
(ii) ceases to have effect at the end of the period of 40 days beginning with the day on which the instrument is made unless, during that period, the instrument is approved by a resolution of each House of Parliament and by a resolution of the Assembly.
(8) In calculating the period of 40 days for the purposes of subsection (7)(a)(ii) or (c)(ii) in relation to Parliament, no account is to be taken of any time during which—
(a) Parliament is dissolved or prorogued, or
(b) either House of Parliament is adjourned for more than 4 days.
(9) In calculating the period of 40 days for the purposes of subsection (7)(b)(ii) or (c)(ii) in relation to the Northern Ireland Assembly, no account is to be taken of any time during which the Assembly is—
(a) dissolved,
(b) in recess for more than 4 days, or
(c) adjourned for more than 6 days.
(10) If regulations cease to have effect as a result of subsection (7) that—
(a) does not affect the validity of anything previously done under the regulations, and
(b) does not prevent the making of new regulations.”
Member’s explanatory statement
This amendment provides for urgent regulations made in reliance on clauses 6 and 15 (emergencies) to be subject to the made affirmative procedure rather than the negative procedure and for regulations under clauses 2(1)(j), (k) or (n) and 9(1)(f), (k) or (l) to be subject to the draft affirmative procedure rather than the negative procedure.

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[Baroness Thornton (Lab)]

The only question I want to ask is the question the noble Lord, Lord Sharkey, has just asked. Can the Minister give a rational explanation about why certain parts of the Bill come into force at different times? The key question on commencement is whether the commencement schedule as drafted risks holding up any of the work that needs to be done or allows the Government to move too slowly on anything.

My colleagues in the Commons drew attention to this provision as essentially a means of saying, “at some point in the future”. Can the Minister give an indication of the timeframe in which the Government expect to get these regimes consulted on, regulated for and up and running? As the Bill is drafted, the timing is left rather open-ended.

[Lord Bethell (Con)]

My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which would require the Secretary of State to act in accordance with the guidance on the use of civil sanctions—I am sorry, I am on the wrong amendment.

Amendment 145, in the name of the noble Lord, Lord Sharkey, seeks to amend the commencement clause, Clause 44, so that all provisions would come into force on the day the Bill receives Royal Assent. I am confident that the amendment is not necessary. Clause 44(1) provides that the clauses needed to make emergency amending regulations will come into force the day the Bill receives Royal Assent.

Under Clause 44(2), a significant number of clauses come into force after the customary two-month commencement period. Chapters 3 and 4 of Part 3 come into force on a day the Secretary of State appoints which is specified in regulations. This combination of commencement provisions is for a good reason. Patients, stakeholders and Parliament must know what the law is before the law is made. The two-month commencement period allows the Government to continue to engage with industry and the relevant stakeholders properly before provisions come into force.

Importantly, Clause 44 provides for the necessary powers and provisions to come into force on Royal Assent should it be necessary, within that two-month period, to make regulations urgently in order to protect the public from an imminent risk of serious harm to health.

I understand that there may be concern about Clause 44(3), which allows the Secretary of State to determine when Chapters 3 and 4 of Part 3 come into force, but I assure the noble Lord that, again, this is for a good reason. Chapter 3 of Part 3 is concerned with enforcement and included in that is the introduction of a civil sanctions regime. Civil sanctions will act as a flexible, proportionate enforcement mechanism, enhancing the MHRA’s ability to incentivise compliance. The new civil sanctions regime requires supplementary regulations to be made under paragraph 9 of Schedule 1 before it can be fully operational. It is important that the MHRA engages with industry and stakeholders on these regulations and the accompanying guidance. Indeed, the Bill requires a consultation to be carried out before they are made. If these provisions came into force on the day the Bill achieved Royal Assent, we would have no time to make the necessary regulations. Our time to consult in advance on those regulations and the guidance would be severely condensed.

It is absolutely right that we consider the views of stakeholders and the public before making the supplementary regulations and bringing the new civil sanctions regime into force. I assure noble Lords that the Government are committed to bringing the enforcement and data and disclosure chapters into force as soon as is appropriate in order to enhance the safety of the medical devices regime. I hope the noble Lord, Lord Sharkey, understands the reasoning behind the clause and feels able to withdraw his amendment.

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

My Lords, I have received no request to speak after the Minister, so I call Lord Sharkey—

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[Lord Lansley (Con)]

I thank the Deputy Chairman. I sent the email only about 30 seconds ago so I suppose, strictly speaking, that apologies on his part are not required. I should have anticipated the need to ask a question, but I am afraid I was prompted by listening to the noble Lord, Lord Sharkey, and the Minister’s reply. I want to ask one question: how can what will become Section 1 be brought into force without Section 2? I do not understand. If a power is to be used under Section 1, it must surely make provision about some of the long list of relevant areas in what will be Section 2. In the absence of Section 2 being in force, I cannot see how Section 1 works.

[Lord Bethell (Con)]

My Lords, I will seek to provide an answer to my noble friend. Should it not be quite the right answer I will endeavour to write to him. It is my understanding that no substantive provision of an Act should be brought into operation earlier than two months after Royal Assent. However, some sections of the Act can be brought into force on Royal Assent, typically those setting out how the Act is to be cited and what the procedure is for making regulations or commencing them. It is under those arrangements that the sequencing which he describes can be undertaken.

[Lord Sharkey (LD) [V]]

I thank the noble Lord, Lord Lansley, for his intervention. I will read Hansard carefully tomorrow to make sure that I understand not only his question but the Minister’s reply. I thank the Minister for his explanations—they were useful—and for the brief preview of his next speech.

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[Lord Sharkey (LD) [V]]

We all know that the words “have regard to” create no real obligations, whereas the words “act in accordance with” do create real obligations. Clause 13 seems to contain important restrictions on the actions of the Secretary of State, but it does so via guidance. As the Bill stands, with its “have regard to” wording, that guidance has no statutory force. If the restrictions are to have any reality—and I assume that the Government would like them to, or they would not have written them into the Bill—we must replace “have regard to” with “act in accordance with” as the amendment proposes. We support the amendment.

[Lord Bethell (Con)]

My Lords, I thank the noble Baroness, Lady Thornton, for her amendment, which is designed to require that the Secretary of State must “act in accordance with” the guidance on the use of civil sanctions that he is required to publish under paragraph 13 of Schedule 1, as opposed to having regard to the guidance. Paragraph 13 requires the Secretary of State to prepare and publish guidance about the use of civil sanctions. More specifically, this guidance must cover the sanctions that may be imposed if a person commits an offence, the action the Secretary of State may take, and the circumstances in which action is likely to be taken.

I understand the intention behind Amendment 146 and recognise that it is crucial that civil sanctions are imposed in a transparent and consistent manner to ensure that the regime operates effectively. However, the current drafting of Schedule 1, including the obligation on the Secretary of State to publish and have regard to guidance on the civil sanctions regime, will ensure this transparency and consistency.

The guidance will be prepared after consultation with the devolved Administrations and others. The purpose of any guidance is to provide clarity to the civil sanctions regime and detail the circumstances in which different civil sanctions may be pursued. However, instances of non-compliance or criminal activity, where the medical device regulations are concerned, need to be dealt with on a case-by-case basis. The scale, complexity and severity of non-compliance can vary significantly. As such, any resultant enforcement activity needs to be proportionate, effective and commensurate with the non-compliance or criminal activity.

The amendment in the name of the noble Baroness, Lady Thornton, would bind the Secretary of State, acting through the MRHA, to act in accordance with guidance in every instance. This would limit the regulator’s ability to arrive at and undertake the most appropriate course of enforcement action commensurate to the multifaceted nature of the case at hand. The MHRA cannot set out every circumstance where it may be appropriate to impose civil sanctions. However, by preparing, consulting and publishing a clear set of guidance we can be clear on the framework and illustrate circumstances on how and why a civil sanction might be imposed without being exhaustive.

The regulator needs civil sanction guidance that is flexible enough to appropriately address all forms of non-compliance. To mandate following the guidance to the letter could potentially mean that no action can be taken if the MHRA encounters a new example of non-compliance that has not been explicitly catered for in the guidance but clearly warrants a civil sanction. Under such circumstances, the Secretary of State will, of course, comply with obligation to publish revised guidance as required in paragraph 13 of Schedule 1.

I remind noble Lords that recipients of civil sanctions can contest the imposition of a civil sanction before it takes effect by appealing to the First-tier Tribunal. It is also worth highlighting that, as currently provided, the guidance will be statutory guidance and the regulator must have regard to it when carrying out enforcement activity.

Furthermore, this type of provision is standard across the statute book. For instance, provisions requiring regulators and statutory bodies to “have regard” to statutory guidance can be found in a wide range of legislation, from Section 2 of the Higher Education and Research Act 2017 to Section 5 of the Business and Planning Act 2020. In a civil sanctions context, Section 63 of the Regulatory Enforcement and Sanctions Act 2008 provides that provisions conferring a power on a regulator to impose a civil sanction must also make provision relating to guidance—in particular, that the regulator “must publish guidance” about its use of a sanction and

“have regard to the guidance … in exercising its functions.”

The Ecodesign for Energy-Related Products Regulations 2010 has a similar civil sanctions regime. These regulations are concerned with the establishment of a framework for the setting of ecodesign requirements for energy-related products. In paragraph 28 of Schedule 5 to those regulations the market surveillance authority

“must have regard to guidance”

while exercising his or her functions with regard to the imposition of civil sanctions. I hope that the reassurance we seek is not unusual but in line with how civil sanction and, indeed, other regimes operate domestically. For that reason, I therefore ask the noble Baroness to withdraw Amendment 146.

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

My Lords, I think that I have received no requests to speak after the Minister so, hoping that I have not overlooked the noble Lord, Lord Lansley, once again, I call the noble Baroness, Lady Thornton, to conclude this debate.

Covid-19: Conflicts of Interest

Lord Bethell Excerpts

Wednesday 18th November 2020 Lords Chamber

[Lord Scriven]

To ask Her Majesty’s Government what assessment they made of conflicts of interest before engaging specialist advisers to inform their response to the COVID-19 pandemic.

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

My Lords, in our nation’s time of need we have been very fortunate to call on the talents of many, including colleagues old and new, some paid and some unpaid. Appointments are considered on merit and, when required, we ask candidates to declare any interests. We assess these on a case-by-case basis, but declaring an interest is not always a barrier to being appointed. There are, however, robust processes in place to manage any conflict. These ensure that no one gains unfairly from advising the Government.

[Lord Scriven (LD)]

My Lords, can the Minister give a logical reason why a company with no history of supplying PPE that is introduced by a special adviser can be passed from a Minister’s office, be fast-tracked and be 10 times more successful in getting a contract to supply PPE—which sometimes cannot be used because it does not meet the standards—than a company with a solid track record of supplying PPE that has no access to a special adviser or Minister?

[Lord Bethell (Con)]

My Lords, we are enormously grateful for the very many people who stepped forward to offer help during this time. When the Prime Minister made his public call for help, 16,500 people contacted us with various offers. It was, of course, necessary to triage and prioritise that huge list. In that list there were a great many people who had extensive experience in their area; there were people who were new to the game; there were have-a-go heroes; there were multinational companies. There were also those whose intentions were not as pure as one would hope. We approached each and every one on their merit, and there were official guidelines to guide the procurement processes. We have stuck to those guidelines every step of the way.

[Lord Harris of Haringey (Lab)]

Yesterday the Minister said that he had personally made 300 calls to potential suppliers of PPE earlier this year. Not surprisingly, given the report from the National Audit Office today, which the Daily Mail described as devastating, he did not tell us how the lucky recipients of all his calls were chosen. Could the Minister tell us whether one of those calls was to the jewellery designer Michael Saiger, based in Miami, who received more £200 million in contracts from the Minister’s department, paying £21 million to a Spanish fixer? How did Mr Saiger and his jewellery come to the attention of the department? Why were major British companies with well-established global supply chains, which offered to help, ignored?

[Lord Bethell (Con)]

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

[Baroness Jolly (LD) [V]]

My Lords, Ministers have many opportunities to meet a wide range of individuals and organisations in the course of their work, and they have to declare their interests. Is it the department’s HR department or its Ministers who are responsible for ensuring that spads understand both their role and their boundaries, and that they stay within them?

[Lord Bethell (Con)]

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

[Lord Robathan (Con)]

My Lords, I have a certain sense of déjà vu, since this is almost exactly the same question that was asked yesterday, so I will try not to be repetitive. I know my noble friend is, like me, grateful to those who came forward and freely, pro bono, gave their time, expertise and experience to assist in this terrible crisis. I know he will also, like me, share the view that some people are grubbing around, looking for any dirt they can sling that will deter good public-spirited people from coming forward in future. I have one specific question: could the Minister tell me how long, typically, a procurement process would last if you are looking to get PPE through the Civil Service procurement procedures?

[Lord Bethell (Con)]

My Lords, my noble friend makes a very good point. I cannot tell him how long it would typically take but I can tell him that if everything went as smoothly as possible, 25 days is the absolute minimum that a procurement process could take. That is why, on 18 March, new guidelines for procurement were put in place. The PPE team converted those into a very diligent eight-step process, the effectiveness of which the NAO has paid tribute to. We have put in place exactly the kind of reasonable processes necessary to respond to a pandemic like this, resulting in the purchase of billions of items of PPE to protect those on the front line of our healthcare.

[Lord Berkeley of Knighton (CB) [V]]

My Lords, I do not discount the many problems the Minister has talked about, but the displeasure—disgust, even—of the public often arises as a result of the National Audit Office uncovering information reactively, for example. What we need is a more proactive lookout for these problems, either in the Cabinet or the Cabinet Office. If the Minister says it is there, I would suggest that the National Audit Office is saying that it does not work very well.

[Lord Bethell (Con)]

My Lords, I am not sure that that is what the National Audit Office has said. It has, very reasonably, alighted on the importance of transparency and the declaration of interests, values that any reasonable Minister or public servant would subscribe to. The Cabinet Office itself has played a very energetic role during the entire pandemic, providing the systems, support and people, including contract staff, to make sure those values are upheld.

[Baroness Thornton (Lab)]

May I just say to the noble Lord, Lord Robathan, that we supported the Government having the emergency powers to allow them to act quickly but it is also important, even if people are giving their services for free, that they are held properly accountable.

It is rare to be able to return to a question that one feels was unanswered the day before. I asked the Minister if George Pascoe-Watson, the chair of the lobbying company Portland Communications, had signed a confidentiality agreement upon his appointment as a ministerial adviser. I would be grateful if the Minister could specifically answer that question: did George Pascoe-Watson sign a confidentiality agreement when he was appointed? Presumably, that is on the public record. Would the Minister also inform the House if he or any of his officials have had any contact, by any means of communication, with Mr Pascoe-Watson or anyone else at Portland Communications since the Sunday Times published its story online on Saturday evening?

[Lord Bethell (Con)]

My Lords, the very large number of advisers, both paid and unpaid, were all processed by the department and their paperwork was then handed on to the Cabinet Office for approval. George Pascoe-Watson, as others, was sent both a declaration of interest form, which he filled in and is on record, and a volunteer agreement, which has the Official Secrets Act built into it. His work was covered by that.

[Baroness Smith of Newnham (LD) [V]]

My Lords, could the Minister tell the House whether the Government’s anti-corruption champion, John Penrose MP, has been involved in looking at any conflicts of interest or whether he is in danger of having a conflict of interest himself?

[Lord Bethell (Con)]

I am not aware of him being involved in the work to which the noble Baroness refers.

[Lord Empey (UUP) [V]]

My Lords, does my noble friend not accept that the arrival of battalions of advisers, both paid and unpaid, causes confusion within departments about the chain of command? Does he also agree that, as a general principle, the arrival of so many advisers in the Civil Service downgrades the role of the Permanent Secretary as the principal adviser to the Secretary of State?

[Lord Bethell (Con)]

The noble Lord asks a reasonable question about the management of staff in an epidemic such as this. He is right that these were extremely confusing times that put a huge amount of pressure on civil servants and all those who contributed to our response. I am enormously grateful to civil servants for their work, in particular Sir Chris Wormald, our Permanent Secretary—he played an absolute blinder and is one of the top civil servants of his class—and David Williams, the Second Permanent Secretary of our department. Both were absolutely fantastic.

I am grateful to all who stepped forward, not just at a senior level—from noble Lords who worked with us to people who worked at other levels of our response. It made a huge impact. The arrival of military advisers, consultants, volunteers and business advisers lifted the spirits of the whole organisation and brought with it networks of expertise and energy, which saw a huge amount of collaboration. When I hear a debate such as this and the tone that is sometimes represented in the Chamber, I do not recognise the incredible spirit of energy and collaboration that characterised our response to the pandemic. I cannot help repeating myself: it is something that I am extremely proud of.

[The Deputy Speaker (Lord Faulkner of Worcester) (Lab)]

My Lords, the time allowed for this Question has elapsed. I apologise to the three noble Lords who were unable to ask their supplementary questions.

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.

--- Later in debate ---

[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.

--- Later in debate ---

[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.

--- Later in debate ---

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.