Health and Care Bill

Lord Kamall Excerpts

Lords Hansard - Part 2 & Report stage
Tuesday 1st March 2022 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, this is an important group, so it is a shame that we are discussing it so late in the evening. It is important because it contains essential broad things that people need to stay well in their community. It is about the bread and butter of people’s health—their GPs, dentists, the physios and pharmacists, getting podiatry services and getting the proper social care that you need to be able to stay in your home. It is literally about helping people to stay local and stay well. In many ways, that is why I enjoyed the three years that I spent on a CCG so much, because I knew that it was local and that every month I was going to be visiting a GP surgery. I knew all those things, and I felt that that was an important contribution to healthcare in my area.

The amendment in the name of the noble Lord, Lord Crisp, is particularly important. If primary healthcare and these local services do not work, the rest of the NHS falls over.

[Lord Kamall (Con)]

My Lords, I am grateful to all noble Lords who have spoken on these amendments in this debate and in Committee, but I am also grateful for the discussions that we have had between the various stages and the conversations that noble Lords have continued to have with my officials—indeed, right up to the dinner break this evening. I shall speak to Amendments 34, 35 and 55 in my name, which I hope will go far in addressing many of the concerns raised in the debate.

We have heard the calls for greater clarity about what will be expected of ICBs in their forward planning. We also understand the importance of ICBs being transparent in discharging their functions to allow for public scrutiny and accountability. We have therefore brought forward these amendments to further clarify what ICBs must include in their forward plans and annual reports. These amendments provide that the forward plan must describe what services the ICB proposes to make arrangements for in the exercise of its functions. It must also explain how the ICB proposes to discharge each of its duties under new Sections 14Z34 to 14Z44. These duties include improving the quality of services, reducing inequalities, promoting the involvement of patients and carers in decisions about treatment and promoting the integration of health and social care services.

Amendment 55 requires an ICB’s annual report to explain how it has discharged each of its duties under new Sections 14Z34 to 14Z44. This would additionally include new Section 14Z47A, which is the new duty we discussed earlier requiring the ICB to keep under review the skills, knowledge and experience that it needs to discharge its functions and, when there are gaps, to consider what steps it can take to address or mitigate them. I hope that noble Lords will agree that these amendments represent a significant step forward in making sure ICBs are held accountable by ensuring that they are transparent in how they intend to discharge their numerous duties and functions.

I turn to the amendments proposed by noble Lords, and I shall address each of them as briefly as I can. On Amendment 19, I assure my noble friend Lord Farmer that the Bill already includes the power for ICBs to commission services or facilities for the prevention of illness under new Section 3A in Clause 16. The provisions in Clause 16 also require ICBs to act consistently with the Secretary of State’s duty for the promotion of a comprehensive health service, including in the prevention of illness. Further, new Section 14Z34 places a duty on ICBs to improve the quality of services including preventive services, and new Sections 14Z36 and 14Z38 place duties on ICBs to ensure that patients and carers are fully involved in these decisions, including about prevention.

I now turn briefly to Amendment 62, spoken to so ably by my noble friend Lord McColl and the noble Baroness, Lady Hollins. I also pay tribute to the noble Baroness, Lady Greengross, who in my brief time in this House thus far has really educated me about dementia and the fact that, as we are living longer physically, this will become more of an issue.

The department is currently developing a new national dementia strategy for England, which will be published later this year. This will include objectives focused on restoring the dementia diagnosis rates and improving the diagnostic experience for people living with dementia, as well as increasing the number and diversity of people participating in dementia research. I take on board the concern of the noble Baroness, Lady Walmsley, about getting the many volunteers for clinical trials at the right time.

There is already work under way to help restore dementia diagnosis rates back to the target of 66.7% following the pandemic, supported by an additional £17 million to address dementia waiting lists and increase the number of diagnoses. Increasing participation in all types of research is a top priority and is in fact part of my portfolio. The UK has invested in a range of digital platforms, including Join Dementia Research, and we are now working to increase the scale of and interoperability between systems, improve diverse recruitment and reduce the burden and costs of clinical research delivery.

On Amendments 22 and 24, I reassure noble Lords that the Bill already contains requirements on NHS commissioning bodies to tackle health inequalities. Commissioners are also required to promote the right of patients to make choices with respect to services or treatment. This includes allowing patients to choose to be treated outside their ICB area. To support this, we expect ICBs to actively co-operate with each other. Furthermore, we have amended the duty on ICBs to have regard to the need to reduce inequalities between patients, proposing by government amendment to extend this to “persons”, in respect of accessing services. This means we are capturing everyone, not just people accessing services. This duty would encompass the need to reduce inequalities with respect to geography as well.

I now turn to Amendment 30. I thank the noble Baroness, Lady Finlay. First, I should thank her for the daffodil I am wearing to celebrate St David’s Day. She assures me that it is not a listening device to eavesdrop on my conversations with officials. If she had eavesdropped, she probably would have been embarrassed by the amount of praise heaped on her. We acknowledge her desire to see strong provision of community rehabilitation and it is important that this is pushed up the agenda.

Under the existing Bill provisions, every ICB will be required to provide and improve rehabilitation services as part of its duty to provide a comprehensive health service. As an added layer of scrutiny, ICBs must publish an annual review detailing how they have discharged this function. Also, NHS England is currently working on a national intermediate care framework, digital and virtual pathways and models of care, improved data recording and reports, and interventions using a wide range of community assets and levers.

I now turn to Amendments 33 and 37 to 54. I thank the noble Lord, Lord Crisp, for his engagement on this issue—indeed, including right up to the dinner break this evening. We would like to put on record our gratitude to the noble Lord and the Royal College of General Practitioners for pushing us on this and reminding us that, as we move to ICBs, we should make sure that primary care is not the poor relation. In moving to ICBs from CCGs, where GPs and primary medical services have played a huge role, we have to ensure that these are not dominated by a few large trusts.

We understand and continue to recognise the importance of primary care. Indeed, primary care is taking on more of the functions of what would traditionally be considered secondary care, especially with some of the primary care services and community centres appearing in our local communities. Only this week, we have seen stories and press reports of pharmacists calling for more of the functions of GPs to be delegated to them. They have helpfully suggested that they could save the NHS money and also provide better primary care services by taking on some of those functions. There is clearly a demand out there and that has to be encouraged.

Before I turn to this, I note that we hold primary care in equal esteem to any other sector—acute, community or mental health. Right from the outset, we have said that primary care must not be lost and must be at the heart of the ICB. As the Integrated Care Systems: Design Framework said:

“Through a combination of their membership, and the ways in which members engage partners, the board and its committees should ensure they take into account the perspectives and expertise of all relevant partners”,


including primary care.

I know the noble Lord is especially concerned about why primary care is not explicitly referenced in new Clause 14Z50(1). I hope I can offer him some explanation. First, we are conscious that there are 43,000 primary care providers, and it is impractical to require each to be a partner in developing the ICB forward plan. Secondly, new Clause 14Z50 ties NHS providers to the plan, and a failure to play their part could trigger NHS England’s intervention. It will also guide the financial requirements imposed under Clause 24. In contrast, primary care providers, as private contractors, are bound to the plan in a different way, primarily through contracts. Thirdly, new Clauses 14Z50 and 14Z54, on the joint capital resource plan, are intimately connected and primary care capital is provided through other routes.

However, ensuring that the primary care voice is sufficiently involved in joint forward planning in integrated care boards is our common ambition. The law requires the involvement of a primary care representative drawn from primary medical services on ICBs, just as it does for acute providers. ICBs will have to consider how they can best access skills and knowledge across primary care.

In addition, there is a duty in new Clause 14Z52 to consult

“any other persons they consider it appropriate to consult”

about forward plans. We expect that, in publishing its plan, an ICB should set out how it has met this duty and consulted primary care and other partners. I am able to inform the House that NHS England has confirmed that its guidance will be explicit in its expectation that primary care will be a crucial partner in that process. We are happy to engage with the noble Lord further as that guidance develops to ensure that we stick to that commitment to make sure that primary care is at the heart of this.

More broadly, ICBs have the discretion to appoint additional members to the ICB or exercise functions through committees. Commissioning at a local level requires the expertise of primary care, and we expect it to play a significant role as many decisions will be taken at that level under the principle of subsidiarity. Further guidance will be published on the development of place- level arrangements, including the role of primary care.

I also note the Fuller review. NHS England chief executive Amanda Pritchard has announced that Dr Claire Fuller, senior responsible officer of the Surrey Heartlands Integrated Care System, will lead a review on how primary care networks can be supported in integrated systems. NHS England has announced that the review will set out how ICSs and primary care networks should go about improving out-of-hospital care. The findings of the review will then be applied to ICBs, subject to the passage of this Bill. We hope this work will help all ICBs to make progress on developing general practice in this area.

I hope I have been able to assure noble Lords that we hold primary care in great esteem, and have given the noble Lord some reassurance that primary care will be involved in every level of the ICB, its functions and planning.

I now turn to Amendment 177 from my noble friend Lady Hodgson. I thank her for continuing to remind us of its importance and speaking movingly about her own experience. I remind noble Lords that all practices are already required to assign all their registered patients—including those aged 65 and over—a named, accountable GP. The GP must lead in ensuring that any GP services that they are contracted to provide, and that are necessary to meet the patient’s needs, are co-ordinated and delivered to that patient. Practices must take reasonable steps to accommodate the requests of patients to be assigned a particular GP and to see them for an appointment.

However, it is vital that practices retain clinical discretion to provide appointments, as is necessary and appropriate to meet the reasonable needs of patients—something that this amendment would remove. Through primary care networks and initiatives such as enhanced health in care homes and anticipatory care, we are supporting GP practices to improve continuity of care on the ground, including for older patients. We are committed to growing the general practice workforce and increasing access to appointments, in line with our manifesto commitments.

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Moved by

[Lord Kamall]

20: Clause 20, page 16, line 33, leave out “patients” and insert “persons”
Member’s explanatory statement
An integrated care board has a duty to have regard to the need to reduce inequalities in access to health services for patients. The amendment extends it to cover people before they are patients.

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Moved by

[Lord Kamall]

23: Clause 20, page 17, line 16, at end insert “facilitate or otherwise”
Member’s explanatory statement
This amendment provides that an integrated care board’s duty to promote research etc includes doing so by facilitating research.

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Moved by

[Lord Kamall]

25: Clause 20, page 18, line 27, leave out “The reference in subsection (1)” and insert “In subsection (1)—
(a) the reference”Member’s explanatory statement
This amendment is consequential on another amendment which provides that references in new section 14Z43 of the NHS Act 2006 to effects of a decision in relation to certain matters include its effects in relation to inequalities with respect to those matters.

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Moved by

[Lord Kamall]

28: Clause 20, page 18, line 38, at end insert—
“14Z43A Duties as to climate change etc(1) Each integrated care board must, in the exercise of its functions, have regard to the need to—(a) contribute towards compliance with—(i) section 1 of the Climate Change Act 2008 (UK net zero emissions target), and(ii) section 5 of the Environment Act 2021 (environmental targets), and(b) adapt to any current or predicted impacts of climate change identified in the most recent report under section 56 of the Climate Change Act 2008.(2) In discharging the duty under this section, integrated care boards must have regard to guidance published by NHS England under section 13ND.”Member’s explanatory statement
This amendment would require integrated care boards, in exercising their functions, to have regard to certain matters relating to the environment, including climate change.

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Moved by

[Lord Kamall]

31: Clause 20, page 20, line 18, at end insert—
“14Z47A Duty to keep experience of members under review etcAn integrated care board must—(a) keep under review the skills, knowledge and experience that it considers necessary for members of the board to possess (when taken together) in order for the board effectively to carry out its functions, and(b) if it considers that the board as constituted lacks the necessary skills, knowledge and experience, take such steps as it considers necessary to address or mitigate that shortcoming.”Member’s explanatory statement
This amendment requires an integrated care board to keep under review the skills, knowledge and experience that it is necessary to have on the board and take steps to address or mitigate shortcomings.

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Moved by

[Lord Kamall]

34: Clause 20, page 21, line 12, at end insert—
“(za) describe the health services for which the integrated care board proposes to make arrangements in the exercise of its functions by virtue of this Act;”Member’s explanatory statement
This amendment requires the joint forward plan for an integrated care board and its partners to describe the health services that the board proposes to commission over the next five years.

Health and Care Bill

Lord Kamall Excerpts

Friday 25th February 2022 Lords Chamber

Moved by

[Lord Ashton of Hyde]

That the amendments for the Report stage be marshalled and considered in the following order:

Clause 1, Schedule 1, Clauses 2 to 14, Schedule 2, Clauses 15 to 17, Schedule 3, Clauses 18 to 27, Schedule 4, Clause 28, Schedule 5, Clauses 29 to 40, Schedule 6, Clauses 41 to 43, Schedule 7, Clauses 44 to 61, Schedule 8, Clauses 62 and 63, Schedule 9, Clauses 64 to 68, Schedule 10, Clause 69, Schedule 11, Clauses 70 to 74, Schedule 12, Clauses 75 to 98, Schedule 13, Clauses 99 to 112, Schedule 14, Clauses 113 to 123, Schedule 15, Clauses 124 to 149, Schedule 16, Clauses 150 to 159, Schedule 17, Clause 160, Schedule 18, Clauses 161 to 170, Title.

Motion agreed.

Government Contracts: Randox Laboratories

Lord Kamall Excerpts

Monday 21st February 2022 Lords Chamber

[Baroness Thornton (Lab)]

My Lords, at the heart of this Question is almost £500 million of public money, awarded in two public health contracts to Randox Laboratories without competition. My honourable friend asked this Question in the Commons and raised the dissonance in what has been said by the Government over the months since the issue was first raised. I have two questions for the Minister. Does he agree with the former Minister of State for Efficiency and Transformation, the noble Lord, Lord Agnew, that the Government were paying dramatically over the odds for Randox products? If so, can he explain why the Government then entered into a second, more lucrative, contract with the firm? Secondly, the chief operating officer for the Civil Service requested the restoration of competitive tendering by March 2021. Can the Minister set out how many further contracts have been issued after that date without tender and explain why the emergency procurement rules are still in place almost a year later, given that we are coming, as the Prime Minister just told the Commons “out of Covid”?

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

I start by thanking the noble Baroness for those questions. On her first point, we should remember the stage that the Government were at at the beginning of the crisis. People were dying every day and there were panics; they were not sure what was out there. Clearly, they were going out looking for suppliers for testing and other equipment. There were a number of approaches and different meetings, but one thing that has been quite clear is that all contracts were awarded according to the Public Contracts Regulations 2015. I have been reassured about this by officials. Authorities are permitted to procure goods, services and works via direct award, using Regulation 32 of the Public Contracts Regulations 2015, in exceptional circumstances, such as extreme urgency, without competing or advertising the requirement. I contend that the beginning of the Covid crisis was such an emergency, and that is one reason it was awarded without competition. There are clear procedures, we are committed to openness and transparency and details of the contracts are available online.

The decision on whether to procure a product from a supplier ultimately sits with departmental officials once the offer has cleared assurance steps. These include clinical acceptability and financial due diligence. I often get emails from people who have sat next to me somewhere who say, “I have this fantastic product”, but I have to reply to them and say, “I’m very sorry—I will copy officials into this but I can take no further part”.

I shall try to answer on the emergency procurement procedures, but I want to make sure I have the right note. Clearly, there are unforeseeable circumstances such as, for example, the rapid onset of omicron at the end of 2021. That also required UKHSA to act with extreme urgency. We used Regulation 32 in some cases at the end of last year to supply LFTs over the Christmas and new year period due to increased demand. The use of Regulation 32 was necessary because our DPS 2 procurement had reached its limit of extension and there was no time to run additional procurement. I am sure the noble Baroness and others will remember the end of last year, when people just could not get hold of testing equipment and we were trying to buy as much as we could on the world market.

[Baroness Barker (LD)]

My Lords, since the start of 2020, Randox has secured almost £620 million of government contracts and the firm has been shown repeatedly to produce goods which are faulty or do not work. It got those contracts using personal contacts. Will the Minister undertake that there will be an independent investigation of those contracts and recovery of any public money spent on faulty goods?

[Lord Kamall (Con)]

At the time of the award of the original contract in March 2020, almost no UK supply was available and Randox was able to provide an end-to-end testing service. The department then engaged with a number of suppliers in its effort rapidly to build from scratch the largest testing industry in UK history. That has played an important role in stopping the spread of Covid-19 and saving lives. The service that Randox provided was a very important part of that.

A number of Randox home testing kits were recalled in the summer of 2020 after tests found that swabs were not sterilised. A Public Health England investigation did not find any instances of swabs causing ill health. Randox agreed to provide new Covid-19 self-test kits. The contract was necessary to meet the increase in testing needed. An independent assessment in June 2020 had placed Randox ahead of other laboratories, and Randox was meeting its delivery targets by September 2020. Without Randox, we would not have been able to meet the volume of testing needed over the winter period.

[Lord McCrea of Magherafelt and Cookstown (DUP)]

My Lords, I declare an interest in that Randox Laboratories is a major employer in a constituency that I represented for 10 years in the other House. It cannot be challenged that Randox Laboratories has been globally recognised in the diagnostics industry over many years. Therefore, can the Minister place on record the Government’s appreciation for firms such as Randox that rose to the health emergency and exercised their best efforts to achieve our unprecedented national effort?

[Lord Kamall (Con)]

I thank the noble Lord for reminding us of the importance of all the companies that supplied equipment or scaled up at pace or were able to meet the initial requirements. It was a time of panic; thousands were dying, and we did not have equipment. This was a time before the vaccine. The department and its officials tried to speak to as many people as possible around the world to find out what was available, what could be done and what the timescales were. Clearly, as the noble Lord said, Randox played an important role in meeting the testing requirements initially.

[Lord Winston (Lab)]

My Lords, the Minister suggests that the Government were panicking. Does he agree that panic in a laboratory or when one is dealing with tests of this kind is not satisfactory? Is not one of the problems that it is clear that Randox’s methods were not satisfactory and would not stand up to absolutely accurate testing? Is it not the case that the Government still cannot tell us what percentage of its PCR tests were inaccurate or in some ways contaminated?

[Lord Kamall (Con)]

I used the word panic because I think everyone was panicking. People just did not understand what was going on. They did not understand the pace of coronavirus; they did not even understand the disease itself and the transmission of it. I was reading over the weekend a couple of books on the history of the virus so far, where it broke out and what people thought it was originally, and some of the reassessments of historical epidemiology. Clearly, we needed testing performance. Randox was the only company at that time, in March 2020, that was able to provide that capacity at the scale needed. As I said earlier, where we identified problems, we made Randox aware of them and it supplied new kit.

[Lord Robertson of Port Ellen (Lab)]

My Lords, the Government held a full-scale exercise in 2016 based on pandemic flu, Operation Cygnus. Anybody who reads the report of that exercise today can see that there was a looming problem with PPE. Between 2016 and 2020, the Government did nothing about that identified problem, so that, when 2020 came, we domestically produced only 1% of the PPE that was required in the NHS. Why was so little done to be ready for something that had been predicted in advance?

[Lord Kamall (Con)]

The noble Lord makes a point about predicting it in advance, but it is very easy to say that with hindsight. Let us look at a number of different countries and the WHO: some people argue that the WHO and Public Health England had only one job, and they were not prepared for it. Clearly, people were caught unawares; we were not the only country to be caught unawares.

[Lord Robertson of Port Ellen (Lab)]

We did the exercises.

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[Lord Kamall (Con)]

There were countries all around the world which were not prepared. That is why everyone scrambled on to the international market; it is why prices were paid at the time that, with hindsight, would not be paid nowadays. It is important to remember where we were at that stage, what we were trying to get hold of, the world market and our understanding of the virus, and at a time when there was no vaccine.

Covid-19: Lateral Flow Tests

Lord Kamall Excerpts

Thursday 10th February 2022 Lords Chamber

[Baroness Finlay of Llandaff]

To ask Her Majesty’s Government how many COVID-19 lateral flow tests are awaiting approval under the Medical Devices (Coronavirus Test Device Approvals (Amendment) Regulations 2021; how many have been approved; and how many that already hold Medicines and Healthcare products Regulatory Agency approval will fall if not re-approved by the extended deadline of 28 February.

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

As of 3 February 2022, 87 lateral flow devices were in the CTDA approval process, and none have been approved—

[A noble Lord]

Speak up.

[Lord Kamall (Con)]

I am sorry, this is a 2.45 am hang- over. Lateral flow devices from 20 CTDA applications are currently included on the temporary protocol. If we interpret the phrase “Medicines and Healthcare products Regulatory Agency approval” as CE marking, we are currently considering proposals to ensure the continued supply and usage of tests beyond 28 February and will announce plans once a decision has been confirmed.

[Baroness Finlay of Llandaff (CB)]

I am grateful for the Minister’s response despite the late hour of last night’s debate. I am concerned that the information I have is that there are still 200 tests waiting, 46 have been assessed and validated at Porton Down, and the process is not well-aligned with the MHRA processes. What is being done to bring those processes back in line? What is being done to bring forward applications from devices that provide a differential diagnosis between Covid and influenza? These are already being used in Europe, but I understand that none are available in the UK because they have been held up in the validation process.

[Lord Kamall (Con)]

I should perhaps start with some background on this and why we have reached the situation we are in. Her Majesty’s Government began the large-scale procurement of Covid-19 test kits at the height of the pandemic. To ensure supplies for the universal testing offer, Porton Down assesses tests offered to Government. It found that three-quarters of those offered failed to meet their stated performance in their instructions for use. For most testing technology, the manufacturer needed only to do self-assessment to meet the CE marking rules, but clearly, when they were tested, they were not meeting those standards. We considered that the current standard was insufficient and did not keep bad tests off the market. That is why we had a public consultation in April that showed strong support for a more rigorous regime. In terms of avoiding a cliff edge, as it were, if they have not been validated, we are looking at solutions.

[Lord Scriven (LD)]

My Lords, reports indicate that the Government are seeking to implement testing only in health care settings and for the most vulnerable people, along with stopping the requirement to self-isolate if a person has Covid-19, in the next two weeks. What evidence from SAGE and NERVTAG do the Government have to show that at present, this is in the best public health interest of the country?

[Lord Kamall (Con)]

I am not aware of any announcements or measures that accord with the noble Lord’s question.

[Lord Brownlow of Shurlock Row (Con)]

My Lords, for some time I have been testing every day and use testing kits that I acquire online and pay for from the same manufacturers that the Government use to distribute free tests. Why are those tests not registerable through the Government website, so that you can get an email confirmation of a negative test? The QR codes are not recognised if you buy tests yourself.

[Lord Kamall (Con)]

I must say to my noble friend that I was not aware of that, and therefore I will have to go back to the department. If he could write to me about that, I will be happy to respond.

[Lord Hunt of Kings Heath (Lab)]

My Lords, can the Minister say how many British companies are caught in this and waiting for approval? Can he also say how many billions of pounds we have spent importing these tests from China?

[Lord Kamall (Con)]

I will try my best to answer the questions, but if I do not, I hope the noble Lord will accept a written response. Some 25% of approved devices are from UK manufacturers, but it is important, as a fair and neutral regulator of market access that all applicants are treated equally. The Government are working to review applications for devices submitted by the process. At the same time, while we want to make sure that the British tests are of the highest standard, we are determined to harness the power of the UK’s leading diagnostic industry. We will continue to be enormously engaged with UK manufacturers and trade bodies to support a thriving domestic diagnostic industry.

[Lord Foulkes of Cumnock (Lab Co-op)]

My Lords, I wish the Minister a speedy recovery. He has been working late hours and deserves our total sympathy. I wonder, however, whether he could give us some indication of how much was wasted in preferential procurement of this kind of equipment. How much has all the equipment that is now out of date and has to be destroyed cost? I do not blame him for any of it, because he has relatively recently become a Minister, but will we have some kind of inquiry into preferential procurement and the wastage of all this equipment?

[Lord Kamall (Con)]

It is interesting that an earlier question asked if we are looking at British-based manufacturers. We want to be very careful that there is no preference, it is all based on merit and we have tests that meet all standards. To answer the question about the wider procurement process, there was a Question last week when I gave some detailed answers about the write-down of some of the value. We bought some of that equipment at the height of the market when people were desperately trying to buy equipment all over the world. Ships were being redirected en route when people thought they were receiving goods. That is why we paid the market price at the time.

[Baroness Wheatcroft (CB)]

My Lords, there is still the occasionally ping heard. Can the Minister bring us up to date with how many people are still employed on Test and Trace and what the total cost has been so far?

[Lord Kamall (Con)]

That is a valid question and if the noble Baroness could write to me, I will respond.

[Baroness Merron (Lab)]

My Lords, in addition to the need to improve the approval process for lateral flow tests, when can we expect to see a real plan for living well with Covid? Will this include proper provision for better sick pay, improved testing and those who are clinically vulnerable.

[Lord Kamall (Con)]

Clearly, the noble Baroness raises a number of important considerations for when we come up with a living with Covid strategy. At the moment, we are consulting on it to make sure that we have an appropriate strategy that covers many of the issues she referred to.

[Lord Cormack (Con)]

My Lords, am I right in thinking that my noble friend said that 25% of the testing kits are made in this country? Does it follow from that that the other 75% are made in China, or is there a wider field of manufacture?

[Lord Kamall (Con)]

As far as I am aware, they are from other countries; I do not know the exact figure for China. The suppliers that have been chosen have passed our protocol and meet the requirements of the procurement framework. It is really important that we have a rigorous standard, given that we found that many of the tests did not meet the instructions for use, as they claimed. We want a testing regime that is not only one of the best in the world but also very well trusted, especially if we are looking at using home testing for future diagnostics to identify more diseases and viruses, rather than waiting for people to go into hospital.

[Baroness Featherstone (LD)]

My Lords, given the Prime Minister’s announcement that in a couple of weeks, people will no longer have to isolate, what can the Minister say to those who have been shielding for all this time and who are now terrified that if they go out of their door, they will meet someone who is positive, so they will have to stay at home? Are their lives not as valuable as those of the rest of us?

[Lord Kamall (Con)]

I am sure the noble Baroness will appreciate that you always have to get the right balance. There will be those who do not want to stay at home and who want to return as quickly as possible, and you also have to consider the wider economy. We cannot shut down the whole economy for a small section of people. What we have to do is make sure that they are looked after. I have recently seen a submission about what we are going to do in future with people who are now termed clinically vulnerable and extremely vulnerable, and we will be publishing that in detail. In fact, just recently I approved a letter to the noble Baroness, Lady Brinton.

[Lord Watts (Lab)]

My Lords, will the Government learn the lesson of Covid and look at supply chains and the need to stockpile equipment in the future?

[Lord Kamall (Con)]

I could bore for Britain on supply chains. It was one of the academic subjects that I looked at, globally. As we become more economically efficient and supply chains become more efficient, they become more brittle. We saw how the shops were affected by lockdown and by China, and much of the manufacturing, as part of that supply chain, started in China. Companies across the world have looked at different options. Some have looked at sourcing elsewhere; some have looked at stockpiling; some have looked at reshoring; but all those options add considerable costs to the supply chain. Some have even looked at intermediary solutions, including warehousing in cheaper countries and then bringing the goods in closer. I am very happy to go on at length to the noble Lord at any time, but not now.

Medical Abortion Pills

Lord Kamall Excerpts

Thursday 10th February 2022 Lords Chamber

[Baroness Sugg]

To ask Her Majesty’s Government what plans they have to extend the availability of the home use of pills for early medical abortion.

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

We are carefully considering all evidence submitted to the Government’s public consultation on whether to make permanent the temporary measure allowing for home use of pills for early medical abortion. We will publish our response as soon as possible and before the end of March to give providers sufficient time to plan for whatever the outcome is.

[Baroness Sugg (Con)]

I thank my noble friend the Minister for that Answer. The consultation on this finished 12 months ago and the current regulations expire next month. Abortion providers have made it clear that without telemedicine services, we will face enormous demand pressures resulting in longer waiting times, later abortions and even women having to resort to unsafe abortions. It would be very helpful to understand the delay to a permanent decision and why it cannot be reached when the evidence is so clear.

[Lord Kamall (Con)]

One of the reasons, as my noble friend would acknowledge, is that we had lockdown and then we were let out, and then we had more restrictions. We did not want to announce something and then have to go back on it. All I would say is that it was always intended to be a temporary measure. We have looked at the responses to the consultation in order to reach a decision, and we will be issuing our considerations later.

[Baroness Blackstone (Ind Lab)]

My Lords, I wish to declare my interest as chair of the trustees of the Royal College of Obstetricians and Gynaecologists. Following up on the question from the noble Baroness, Lady Sugg, I find it very strange that the Government are taking so long to make this decision. The temporary service that was provided for early medical abortions comes to an end at the end of next month. The evidence is clear. According to a survey of 50,000 women published in a leading medical journal, telemedical abortion is

“effective, safe, acceptable and improves access to care.”

In these circumstances, what is holding up the Government’s decision? It seems obvious that it would be welcomed by doctors involved in the treatment of such women, and by the women who need this care.

[Lord Kamall (Con)]

As I am sure noble Lords will acknowledge, this is a very sensitive area. Initially, it was meant to be a temporary-only service. If we do decide to respect its temporariness, an extension will probably be made to ensure that the clinics and other medical services have time to adapt before returning to the position before the pandemic.

[Baroness O'Loan (CB)]

My Lords, is the Minister aware of a recent study, based on FOI requests to NHS trusts, which revealed that in 2020 more than 10,000 women who took at least one abortion pill at home, provided by the NHS, needed hospital treatment for side-effects? That is equivalent to more than one in 17 women, or 20 women a day, needing hospital treatment. Does the Minister agree that such reports indicate a serious and disturbing lack of understanding by its advocates of the dangers of the telemedical abortion policy?

[Lord Kamall (Con)]

I am grateful to the noble Baroness for giving the other side of the debate; it shows what a difficult subject this is. Sometimes people dig up the wider debate, but I think we have to be very careful and focus on the issue. This was a service offered to women, and the initial consultation was in person, but we made temporary provision, rightly, during the pandemic to ensure that women were treated with dignity, while appreciating that it had to be done at distance. We have looked at whether this should continue to be temporary or become permanent, and we are still weighing up this difficult decision. I think the debate today shows that there are a number of views, and it is not as simple as either side proposes.

[Baroness Barker (LD)]

My Lords, the telemedical abortion service has been evaluated separately in England, Wales and Scotland and it has proven to be world leading. The US Food and Drug Administration has recently approved telemedical abortion care in America on the basis of the UK studies. Does the Minister agree that women’s access to safe, high-quality abortion care in the UK should be non-negotiable?

--- Later in debate ---

[Lord Kamall (Con)]

I do not think that is in question. There is no doubt that women should have access to abortion services and to the right advice, but as the noble Baroness who spoke earlier indicated, there are some concerns and risks. We have to consider all the factors. Of course, it would be wonderful for some people if it was made easier and was available online; others say you must be prepared for the risks. Whatever happens, if something goes wrong, I am sure that the noble Baroness and others would be back here questioning why we did what we did.

[Lord Winston (Lab)]

My Lords, I declare an interest as a fellow of the Royal College of Obstetricians and Gynaecologists and of the Academy of Medical Sciences. Have the Government considered the evidence from Imperial College London—indeed, from my own laboratory—showing that most human embryos are born with abnormalities which are potentially lethal, and they usually die? They are then aborted by the same process which this Bill causes, only at a later stage of pregnancy. This method of natural abortion, which occurs all the time, is mostly without symptoms to the woman: they do not even know that they have lost an embryo. It is safe and does not cause the medical complications which invariably happen with a late abortion, which a woman is then committed to. What are the Government going to do about this, firmly, to make it avoidable in future?

[Lord Kamall (Con)]

I am grateful to the noble Lord for informing me about that—it is something I have learned today. I will take it back and consider what he has said. To return to the Question, when we made this measure it was clear that it was supposed to be temporary. Will have consulted and will look at the consultation and decide what we will do. If we do go back to what it was like before, we will make sure there is a sufficient period to ensure there is no cliff edge.

[Lord Patel (CB)]

My Lord, to return to the original Question asked by the noble Baroness, Lady Sugg, may I respectfully suggest that the Minister is trying to defend the indefensible? The evidence is quite clear about the safety of the procedure. We can have a debate about alternative views, but the evidence from other countries which routinely use this method of treatment is clear: it is safe and more convenient for women, and it should be implemented immediately. Will he take this back to the Department of Health?

[Lord Kamall (Con)]

I think the noble Lord is being slightly unfair. It is a complicated issue and not as simple as people make out. The noble Baroness said that we should be aware of dangers. These are the issues that we considered during the consultation. Whatever we do, we will be criticised— rightly so—but we want to make sure that when we make a decision it is the right decision.

[Baroness Wheeler (Lab)]

My Lords, RCOG data has shown that complications related to abortion have decreased since the telemedicine for EMA service was introduced. The college has warned that failure to make it permanent could lead to more women accessing an illegal abortion. NICE has recommended the service as best practice, so does not its future urgently need to be secured by making it permanent? It does not have to be temporary.

[Lord Kamall (Con)]

As I said, we are looking at the consultation carefully and considering all views. If we made it permanent, there would be lots of criticism, which we have to be aware of and make sure that we have the answers for. If we continue to expect it to be temporary, there will be plenty of criticism. Whatever we do, we will be damned, but we are going to try our best.

[Baroness Bennett of Manor Castle (GP)]

My Lords, the noble Lord, Lord Patel, talked about convenience of telemedicine for women. The fact is that women from the most disadvantaged backgrounds are three times as likely to need an abortion as those from the wealthiest backgrounds. It is not just an issue of convenience. It is a question of whether childcare is available and affordable; whether someone has a zero-hours contract job and cannot afford to take time off; or whether someone does not have access to public transport. This is very much an equalities issue—that abortion is available to every woman who needs it.

[Lord Kamall (Con)]

I agree with that statement but it is not what the Question is about. The Question is about a temporary measure that was put in place and whether it should be made permanent. It involves the consideration of difficult issues, including ethical issues, and we want to make sure that when we come to a decision, it is justified.

[Baroness Boycott (CB)]

Does the Minister accept that, as this provision is medically supported by all the experts, this decision is a political one that discriminates against women and is not based on sound medical evidence?

[Lord Kamall (Con)]

First, I remind the noble Baroness that we have not made a decision. I completely refute the allegation. It is unfair but I expect that, whatever we do on this issue, people will refer to the wider debate and accusations will fly around. I accept that, but we will concentrate on looking at the data and the consultation and make a decision.

Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2022

Lord Kamall Excerpts

Thursday 10th February 2022 Lords Chamber

Moved by

[Lord Kamall]

That the draft Regulations laid before the House on 14 December 2021 be approved.

Relevant document: 25th Report from the Secondary Legislation Scrutiny Committee. Considered in Grand Committee on 8 February.

Motion agreed.

Integration White Paper

Lord Kamall Excerpts

Thursday 10th February 2022 Lords Chamber

[Baroness Brinton (LD) [V]]

My Lords, I declare my interest as a vice president of the Local Government Association. Both the Statement and the White Paper set out a laudable ambition to integrate health and social care and communities, but I am afraid that we echo the disappointment of the noble Baroness, Lady Thornton, especially at the glaring omission of children, young people and disabled people who need care.

While reading the White Paper, I had a sense of déjà vu, and I dug out my copy of the White Paper Integration and Innovation: Working Together to Improve Health and Social Care for All, which was published on 11 February last year—almost exactly one year ago. The tone and the ambition were remarkably similar. All noble Lords know that the Health and Care Bill we are debating at the moment sets out in part how the Government believe that the White Paper from last year is going to be turned into legislation and changes in practice. The Minister knows the real concerns across the House about that practical implementation, and I do not believe that this new White Paper takes matters further forward.

From these Benches we also ask: where are carers? There is zero mention of carers in the Statement but 13 in the White Paper, two in the index and two as part of headings. The remaining nine in the text relate only to the people carers care for. There is no formal recognition of the role and no mention of support directly for them as carers. It says:

“People will move seamlessly between health and care settings because people and those supporting their health and care, including … unpaid carers, will be able to see and contribute to their care record and care plans.”


Is that the best on offer for carers—that they will actually be able to see the care plans? They can usually see them now, although most, I must confess, are still in paper format.

That was one example; I want to go on now to a couple of other issues. Much of the paper talks about how data will transform care in the future. On page 14 it says:

“A core level of digital capability everywhere will be critical to delivering integrated health and care and enabling transformed models of care.”


Can the Minister say—because the White Paper is absolutely silent on this—whether there will be funding for fast broadband across the country, especially in rural areas, to deliver that capacity to every single home? Without it, this entire system will fail before it even starts.

The White Paper also says that

“the data and information required to support them should be available in one place, enabling safe and proactive decision-making … We will aim to have shared care records for all citizens by 2024 that provide a single, functional health and care record which citizens, caregivers and care teams can all safely access.”

Can the Minister say how citizens’ data will be protected so that only those who need access to it will see it? As the Minister knows, this is another area where there is real concern over the Bill.

The paper talks extensively about leaders but in a generic way. There are muddles over NHS leaders, social care leaders and leaders of ICBs. Is it referring to council leaders or just leaders? I have to say that the organogram on page 37 makes the classic assumption of councils being single-tier metropolitan authorities, ignoring the plethora of two-tier council arrangements as well as other key stakeholders such as housing associations. It talks about

“3-5 local authorities within an Integrated Care System”.

Even at upper-tier authorities, that number is way too small with the shadow boards at the moment, and dwarfed when you add in district councils, which have key roles in delivering support for care. Unless this is hiding a proposal from the Secretary of State for Levelling Up, Housing and Communities, this is another massive reorganisation for local government.

Housing is vital to the aims of the Bill. The paper says:

“People’s homes should allow effective care and support to be delivered regardless of their age, condition or health status.”


But housing is not mentioned in the “Next Steps” section. I ask the Minister whether there will be specific funding to ensure that housing can be improved at a local level for people who will need it for the next stages of their lives.

The Statement and White Paper recognise the importance of the workforce—in theory. The section in the White Paper talks about continuous development and joint roles, some of which is very laudable, but what is actually happening in the Health and Care Bill at the moment, where the Government will not commit to proper planning for the workforce, makes this unattainable too.

Above all, from our Benches, we want to know where the resources are that will enable this transformation to take place. Even before this week’s announcement about the patient backlog, the levy for health and social care was already prioritised for the NHS. Every time we have asked the Minister when the social care sector will get the resources it so desperately needs—and what they will be—we are told that it will happen at some point in the future.

We need to know when social care and councils will get the support they need, particularly councils with extra responsibilities in this White Paper and the Bill. The LGA has said, correctly:

“Adult social care is in a fragile position, with councils struggling to balance their budgets … A long-term funding solution is urgently needed.”


Can the Minister tell the House what, where and when resources from both departments will be announced and made available to at least give this White Paper half a chance to get going?

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

I begin by thanking both noble Baronesses for their questions. I will try to answer them within the time and, if I do not, will write to the noble Baronesses or others. I will go through some of the issues, first on place-based models.

As we discussed on the Health and Care Bill, ICBs operate at a system level. They will be working with place-based organisations, including health and well-being boards. We expect several models of place-based alignment and governance to emerge and we are not going to be prescriptive about a single model. We are clear that, whatever model is adopted, in the coming years all places must be characterised by clarity of leadership and accountability; a strong shared mission across the sectors, informed by local citizens; a commitment to integration manifested in removing unnecessary boundaries between services and strengthening connections to agencies able to influence the wider determinants of health and well-being; a strong culture of improvement; and a linked sense of urgency about the need to deliver more integrated care to improve outcomes, particularly care quality.

By that we mean that we do not start thinking in siloed ways—of hospitals or primary care, with social care over there. All these White Papers are building-blocks to help explain some of the intentions behind the Health and Care Bill. The Bill itself creates a flexible framework based on the real experience of making effective change happen locally. This flexibility is designed for a purpose: the stronger integration of health and care services. The White Paper picks up that ambition by making clear the strong commitment of the Government to this agenda and our ambition to make progress. The White Paper will ensure that we go further and faster on health and care integration with local authorities and the NHS to make the most of the forthcoming legislation. It does not contradict the Health and Care Bill.

I will pick up on accountability. Three things are different. There is a wider recognition of the demographic challenges we now face, which will increase. We cannot manage it as just health any more or, even within health, primary, then secondary and care over there. The pandemic showed us that some of the cultural and governance barriers to change that seemed impossible to shift have moved. We have seen this work in lots of places up and down the country. There are some model ICSs, which many noble Lords have drawn my attention to, and case studies; we want to learn best practice without being overprescriptive. The noble Lord, Lord Mawson, has talked effectively about place-based organisations many times and getting the right mix of skills and people for a particular place. What works in east London will not necessarily work in South Yorkshire. Some of it will, but some of it will not. We will learn from best practice.

We can be confident that the approach to accountability set out in the paper will work, because it draws on real examples that are already in place. If you ask local leaders what accountability means to them, they will be able to tell you who can ultimately hire and fire them. That is one version of accountability. They will also give you a list of the people and bodies to which they are accountable—partner organisations, local democratic institutions, staff, patients and service users, as well as regulators. We want to make sure that all that comes together to address accountability.

We hope to have shared care records for all citizens by 2024 but, as noble Lords will remember from the debate about data last night or early this morning, we have to get that balance right to make sure that people trust that data will not be shared unnecessarily or inappropriately. One of the key challenges for any integration is that it needs data across primary, secondary, social care and other agencies but, at the same time, we have to allow people to opt out. When people opt out, they might have to re-register a number of times. We want to avoid people, particularly vulnerable people, being asked the same question time and again. We hope that integration and people speaking to each other will help across the health and social care sector.

On carers, I was in fact having conversations yesterday on that subject, and I am going to be doing a round table with a number of noble Lords. One of the issues is making sure that we professionalise and give real respect to the caring workforce. One of the reasons why we set up the voluntary register was to understand the landscape of care, the different qualifications and levels, so that we can get a clearer understanding of what qualifications carers need and how we can make sure that works across both health and social care, so that staff can move between health and social care without feeling that one is better than the other.

We want to build on existing reforms. We want to talk to a number of partners—the noble Baroness, Lady Brinton, mentioned housing, for example—and in the adult social care White Paper we looked at ideas about people being treated at home, some of the things that will have to be done at home, whether that is done at system level and how to make sure that partners are working together.

One thing I will say is that the vast majority of care workers are employed by the private sector. The increase the national living wage means that they will benefit from a pay rise, but we have also put in money. Some private providers feel that they are using private profits to subsidise others. We are making sure there is more money to make sure that we get a better quality of service right across. What we really want to do is say, “Tell us where it doesn’t work and where it breaks down” and to make sure that at the place-based level they are able to work together. We will speak to as many stakeholders as possible and we will continue to ask them to inform us.

I will try not to run over time, but I shall talk about the single accountable person. This will be agreed by the local authority and the integrated care board. An increase in long-term conditions and an increase in the number of people being treated for them means that, increasingly, the co-ordination between the range of services looking after them can fall apart; we know that too many people fall between the cracks. That is why we want to have the single accountable person—so that we can make sure that people are no longer falling through the cracks.

I know I have gone on a bit long, so I will allow other questions to come in, but I hope that addresses some of the concerns.

[Baroness Finlay of Llandaff (CB)]

My Lords, before I ask my question, perhaps I might formally apologise to the House for an error I made last night in Committee on the Health and Care Bill in responding to the debate on my Amendment 287 on dispute resolution and children’s palliative care. I had missed email correspondence from Together for Short Lives prior to the debate, in which the organisation had offered to discuss my amendment with me. I hope the House can accept my sincere apologies and regret at my inaccuracy. I have had helpful correspondence with the charity today.

I turn to today’s Statement. In my role as chair of the Mental Capacity Forum, I welcome the mention in item 5.14 of training in mental capacity, because there is a tremendous need for training at every level.

I also welcome the concept of personalised care, but I am concerned that the paper before us just does not go far enough. We need to document what matters to a person, and that needs to be an ongoing dialogue, not a tick-box exercise. If we know what matters to a person, that can inform best-interest decisions if the person loses capacity, and it is important for informal carers and family members to know that beforehand. Personalised care must include emotional care.

I am also concerned that there is nothing here about training the unpaid carers. They do not just need training in physical aspects of care; they need emotional training and training in how to de-escalate their own emotional stress, particularly when dealing with mental health issues in the person that they are caring for. There is nothing here about child carers and how information goes to a school that a child is a carer and may be under tremendous stress—or it may be that I have missed it in the documentation.

I hope the paper will stress the importance of people being listened to, which will inform decisions when deterioration happens. I would welcome the Government’s comment on how they are going to train enough people and instigate training across the board, both in sensitive listening skills and in achieving the high aspirations that I think the paper has attempted to set out.

[Lord Kamall (Con)]

I thank the noble Baroness for her clarification and for notifying me earlier about the issue that she apologised for. One of the issues for us is that we want to make sure that if all the parts of the healthcare and social care systems are talking to each other, and there are accountable people, we hope that people will not fall through the cracks and that there is a multi-agency approach. It will be difficult to be overly prescriptive here, because what would work in one area might not work in another.

The point that the noble Baroness makes about training is critical. In many debates in this House, we have understood that we need to take the social care workforce seriously and give support to unpaid carers of whatever age, whether they are children or family members. Sometimes they are doing it because they do not want their loved ones to go into a home and sometimes they just need a bit of respite. We are looking at a number of issues around carers—first, unpaid carers but, secondly, making sure that being a carer is a rewarding career and is not seen as being at a lower level than, say, a nurse in the health service.

One reason for having a voluntary register, for example, is to understand the landscape and then put in place proper and different educational pathways, and other pathways, into care. Having national qualifications at levels 4, 5 and 6 and so on will show parity of esteem and that this is a worthwhile career. We have the Made with Care campaign to start to encourage more people back. We are looking at a number of different ways to make sure that carers are not just forgotten. If they work in care homes, that is fine, but we want to make sure that there is a real career structure for them, and also that they can move between health and social care, both ways. There may well be nurses or doctors who want to move across. We have to make sure that going from one place to another is not seen as disadvantageous in any way and that the system is truly joined up.

Of course, this is all top level and shows our ambition to integrate. We do not want to be overly prescriptive; decisions have to be made at place level.

[The Lord Bishop of St Albans]

My Lords, I declare my interests as a vice-president of the Local Government Association and president of the Rural Coalition. I want to pick up very briefly on what the noble Baroness, Lady Brinton, said about rural issues. It is disappointing that there are no explicit references to rural health. One of the concerns of the APPG on Rural Health and Social Care parliamentary inquiry was the way in which inappropriate data, metrics and funding formulas can disadvantage rural areas. National programmes are one thing, but when they are delegated to local areas how are we going to ensure that they are properly rural-proofed and will integrate both health and care?

[Lord Kamall (Con)]

It is important to stress once again that the key to this is that we cannot overly prescribe from here in Westminster and Whitehall. We must make sure that at whatever place, whether it is rural or urban, the people and patients who are cared for in the system are being understood. One reason why we want one person to be accountable, whether in urban or rural areas, is the fact that they must take responsibility for ensuring that all these things are joined up—not only health and social care as we understand them but technology, housing and all those other issues. I know that the right reverend Prelate and my noble friend Lady McIntosh have often raised this issue. We think that the proposal is flexible enough, whether in an urban or a rural area, to make sure that one person really understands the local area of integration.

[Lord Lansley (Con)]

My Lords, paragraph 1.11 of the White Paper states:

“Our focus in this document is at place level.”


Paragraph 3.11 goes on to state:

“Success will depend on making rapid progress towards clarity of governance and clarity of scope in place-based arrangements.”


As far as I can see, the Government are proposing that by spring next year such place-based arrangements will be put in place across the country, with a single accountable person to whom my noble friend referred. There is no reference at all to place-based arrangements in the Health and Care Bill. For years, the NHS has been saying, “We are creating integrated care systems but they don’t have statutory cover, so we want legislation that reflects our way of working”. The Government are now proposing legislation that creates a way of working with no legislative cover. I am afraid that this will not work unless the Bill changes to reflect place-based arrangements and a single accountable person, and defines adequately who they are, what their powers are and how their accountability works.

[Lord Kamall (Con)]

I thank my noble friend for that helpful intervention.

[Noble Lords]

Oh!

[Lord Kamall (Con)]

I respect my noble friend for his willingness to pass on the benefit of his many years of advice to me.

We do not want to get overly prescriptive. We have talked about health and well-being boards and I know that my noble friend has talked about their importance. In the papers I laid in the Library the other day, where we looked at integrated care boards and integrated care partnerships it was quite clear that, in some places where the health and well-being boards may well completely overlap with the ICPs in a smaller area, that will continue to be the place-based level. Where there is a larger system, we expect the integrated care board and integrated care partnership to work with the local place-based organisations underneath them at a more local level. That is what we have been saying all the way through. We want to make use of existing fora. In some places they will overlap and may well end up as the same thing. We will update the health and well-being board guidance in due course to reflect the implications of policies set out in the White Paper and what comes out of the Health and Care Bill when it passes.

[Baroness Donaghy (Lab)]

My Lords, mine is a simple question. We have two separate pieces of legislation on the same area. How does the Minister guarantee that we will not end up with two contradictory systems?

[Lord Kamall (Con)]

The only legislation I am aware of is the Health and Care Bill; this White Paper complements that, just as the adult social White Paper does. This is not legislation.

[Lord Mawson (CB)]

My Lords, I welcome the White Paper and the direction of travel. I thank the Minister and his colleagues for being willing to listen to me and colleagues in the NHS who are involved in actual practical pieces of innovation in this space. It is good to see real examples of the implications for real people in this White Paper. There is also lots of focus on practical and detailed changes—for example, streamlining training and qualifications and shared outcomes. I wonder whether sufficient attention is paid to the social determinants of health and getting upstream with regard to prevention. Is there still too much assumption that the state is doing all the work? The private and voluntary sectors are the major delivers of care. Does the model of partnership proposed fully reflect this? The Minister might like to reflect on that.

Finally, as always, the devil is in the detail and will be all about implementation. One of the ways of achieving this focus is, as I have said before, through establishing innovation platforms that embody the ideas of not only the White Paper but the Health and Care Bill, levelling up and many other current initiatives. Innovation platforms can start to bring together some of these initiatives. It is our experience on the ground that a lot of the public sector systems and processes are not in place and are not fit for purpose. There needs to be innovation in this space. The problem could be an opportunity if we start to join some of this up. How do the Government intend to join up these various initiatives?

[Lord Kamall (Con)]

In many ways, the answer is not what the Government intend to do but what happens at the place-based level. As the noble Lord has reminded me on a number of occasions, some of the projects that he has been involved in and other social enterprises have been really good at bringing people together. Sometimes it has been led by local councils; sometimes it has been led by social enterprises; sometimes it has been led by networks. I completely understand the premise of the question and agree that it has to be a partnership. It is not just a state, but social enterprises, co-operatives, local movements and local civil society all working together with common aims. Go to any part of this country and you will see a number of these people working together. We have to make sure that there is no overlapping or duplication. This is the real aim of what we are trying to get, making sure that people talk about health and social care but well-being as well.

[Lord Davies of Brixton (Lab)]

My Lords, the one thing I admire about the document is the way in which the meaningless term “levelling up” has been shoehorned into the text. I want to raise the bundle of issues which have been grouped under the heading of parity of esteem between physical and mental health. It is not an issue we need just to have in the back of our minds; it needs always to be front and centre in the development of policy. More could be covered than is in the White Paper. One of the examples given in the White Paper is of Mandeep. It is well chosen. It is a case of someone with mental health problems and diabetes where there is a success to point to: where joined-up working has reduced the differential in suffering from diabetes experienced by people with and without mental health problems. That is a good example of what can be achieved. I hope that parity of esteem will be central in what the Minister is doing.

[Lord Kamall (Con)]

I thank the noble Lord for raising the issue of mental health and parity of esteem, not only here but in our debates on the Health and Care Bill, and for our continuing conversations. We hope that we will be able to find a solution to make sure that mental health has parity of esteem. In previous Bills, health has meant physical and mental health, but I recognise the mood of the House when noble Lords ask for it to be stated explicitly somewhere, even in the triple aim. We are looking at solutions for that. He is absolutely right that it is not just about physical health; it is about mental health, about well-being, about tackling inequalities and about disparities. However, we cannot do that from here. We have to make sure that the place-based organisations, working in partnership with integrated care systems, really understand what is happening locally and are best placed to do that.

[Baroness Jolly (LD)]

My Lords, I welcome the White Paper. How will adults with a learning disability and their carers see a difference in their care and support as a result of it?

[Lord Kamall (Con)]

That is a really important issue. A single point of responsibility will make sure that these things do not fall between the cracks. It ensures that physical health, mental health and well-being all come together. A number of noble Lords have spoken about social prescribing, for example, and where that has been tried and where it might not work in other places. It is important that by talking about integration we get people thinking about integration at the place-based and the system level, but also that we can learn from good examples of what works elsewhere. That is what we hope to see. Sometimes, you just have to put in on the tin and say, “Think in an integrated way.”

Covid-19: Lockdowns

Lord Kamall Excerpts

Wednesday 9th February 2022 Lords Chamber

[Lord Robathan]

To ask Her Majesty’s Government what assessment they have made of the paper A Literature Review and Meta-Analysis of the Effects of Lockdowns on COVID-19 Mortality, published in January; and in particular, the conclusions that (1) lockdown measures during the pandemic reduced COVID-19 mortality by 0.2 per cent on average, and (2) the public health benefits of such measures were outweighed by their economic and social costs.

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

The paper has yet to be peer-reviewed and there are important methodological issues that we would expect the reviewers to address. For example, the figure of 0.2% reduction in Covid-19 mortality from lockdown comes mainly from one of the 34 studies reviewed, while other studies report a reduction in mortality of up to 35%. To examine the trade-off between the public health benefits of lockdown and the economic and social costs requires a wider examination of the evidence.

[Lord Robathan (Con)]

My Lords, I am grateful to my noble friend for that reasoned Answer. I have absolutely no idea whether these conclusions are correct, but does my noble friend think that the formulation of government medical policy should be influenced by a wider range of scientific advice, such as that from the authors of this paper, rather than by the narrow focus of SAGE? This is epitomised by the discredited Neil Ferguson. Is he an ex-member? I cannot quite remember. He is still dragged out by the BBC to spread inaccurate gloom and doom. Can my noble friend also confirm that the Chief Medical Officer, at the Cabinet meeting on 8 December, predicted that without further lockdown by new year London would be like Lombardy was in March 2020?

--- Later in debate ---

[Lord Kamall (Con)]

Before I answer any further questions, I should draw Members’ attention to my registered interests and more specifically to the fact that, when I was the academic research director of a think tank, I invited one of the authors of the paper to speak at an academic webinar. In fact, he did not speak on this issue; he spoke on Lebanese currency—quite different issues, as noble Lords can imagine.

I say in response to my noble friend that what is important is that we look not only at the epidemiological evidence and the medical evidence but, in considering government policy, at the wider range of social, economic and other factors. For example, even within clinical decisions, there were some asking for lockdown in order to prevent hospitals from being overwhelmed, but that was counterbalanced by mental health experts who were very concerned about the impact on mental health. As my noble friend will know, there are also trade-offs with the economy and other issues.

[Lord Patel (CB)]

Would the Minister agree that smoking causes cancer, that the earth is round and that, in a pandemic caused by a respiratory virus, asking people to stay at home at the height of the pandemic reduces transmission of infection? Furthermore, would he agree that meta-analysis is the right way to look at randomised control trials and how they perform but not the ideal method to look at observational studies, as referred to in the Question?

[Lord Kamall (Con)]

The noble Lord makes important points. If we look at the history of the debate about the world being round, at one time scientists believed that the world was flat. Because of scepticism and contestability in science, we have been able to come to the conclusion that the world is round. That shows the importance of science being contestable and of having an open debate.

[Lord Rooker (Lab)]

On the issue of Covid and mortality, does the Minister have a view about the allegations made in the BBC2 documentary last night that there were hundreds of thousands of excess deaths because of the business and political attacks on the AstraZeneca vaccine in the early days? The fact is that its non-profit system did not suit the drug industry’s business plan. The massive allegation that, because of this failure, hundreds of thousands of extra people died, clearly ought to be investigated.

[Lord Kamall (Con)]

I apologise to the noble Lord. I did not see the programme last night. I was swatting up for the Health and Social Care Bill debate today and for this Question. The noble Lord refers to an important point. We should not forget not only the contribution that the research community made towards those vaccines, but also that AstraZeneca was prepared to supply, commercialise and distribute them on a not-for-profit basis. Sadly, it was attacked for doing so, not just for commercial reasons, but also by other countries that engaged in vaccine nationalism and disparaged the efficacy of the vaccine. Unfortunately, people in other countries have lost out. I hope that we do not see this in future.

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[Baroness Brinton (LD) [V]]

My Lords, this paper’s economist authors admit that it reflects their opinions. Extraordinarily, they chose to exclude the most recognised epidemiological research on excess deaths. It is not even peer-reviewed. The conclusions are contradictory to the established annual excess death protocols, published for years by the ONS and other national statistical agencies around the world. Which data should scientists advising the Government and Ministers rely on when making decisions about lockdown?

[Lord Kamall (Con)]

The noble Baroness makes some important points about the meta-analysis in the paper. Undue attention has been given to one paper out of 34 studies. While I am answering the noble Baroness, I will refer to an earlier question. In academia there is a huge debate about meta-analysis in all sorts of fields. The question is what other research should be analysed with meta-analysis. This continues to be an issue of debate among academics in many disciplines.

[Baroness Wheeler (Lab)]

My Lords, I want to follow on from what the noble Lord, Lord Patel, said. The World Health Organization’s authoritative and in-depth research shows the effectiveness of large-scale social distancing measures and movement restrictions—ie lockdown—in slowing down Covid-19 transmissions because they limit contacts between people. Is it not far better to work on the basis of this evidence, as well as our own much-respected evidence from the CMO and his team, rather than a non-peer-reviewed paper from an American think tank?

[Lord Kamall (Con)]

Once again, the noble Baroness makes the point that this paper has not been peer-reviewed. That is an important consideration. The Government were quite clear that they introduced measures including lockdown—in the face of some opposition, but with the support of the Benches opposite—because, on the balance of epidemiological and other evidence, it was important to prevent and reduce the risk of transmission of the disease.

[Baroness Foster of Oxton (Con)]

My Lords, many decisions taken during this pandemic led to unintended consequences across the board. Apart from the devastating economic impact on business and industry, the children of the United Kingdom were most badly affected. Mental health problems escalated, particularly due to lockdowns. I hope that I never live to see another lockdown in this country. Can the Minister tell the House exactly what the NHS is doing to address this particular issue?

[Lord Kamall (Con)]

My noble friend raises an important issue about the trade-offs that had to be considered when the Government announced the lockdown and plan A measures. They also announced measures to restrict the transmission of the disease. Costs and benefits had to be weighed up. It was often a nuanced decision. We are clear about the backlog in tackling mental health issues. In debates on the Health and Social Care Bill, many noble Lords across the House have expressed the importance of tackling mental health issues in this country. We hope to put that at the forefront of future health policy.

[Lord Scriven (LD)]

My Lords, all papers with modelled counterfactuals are excluded from the report mentioned in the noble Lord’s Question. As this is the most common method used in infectious disease assessments, does the Minister agree that this has the practical effect of excluding most epidemiological research from the review?

[Lord Kamall (Con)]

Had I still been in academia and was asked to referee this paper for a journal, I would have pointed out a number of issues, including the focus and bias on one particular study, for example, and the studies that were excluded without justifying why.

[Lord Davies of Brixton (Lab)]

My Lords, I understand that the rules on replying to Questions mean that there is not enough time for the Minister to explain everything which is wrong with this particular paper. Does he agree that it would be useful to draw your Lordships’ attention to the work of the Science Media Centre, which has provided a comprehensive explanation of its deficiencies?

[Lord Kamall (Con)]

If the noble Lord would like to write to me with details of that paper, I would be happy to share it with other noble Lords.

[Lord Farmer (Con)]

My Lords, 54 health professionals have urged the Commons Public Administration Committee to conduct an inquiry into government use of covert psychological strategies, particularly in Covid messaging, which raise significant ethical issues, including the need to obtain consent. What is the Government’s response to growing evidence of fear inflation and social division due to the equating of compliance with virtue and use of peer pressure to ensure conformity with lockdown and other Covid restrictions?

[Lord Kamall (Con)]

I thank my noble friend for giving me advance warning of his question. The British Psychological Society’s ethics committee has been approached on this topic and has provided a response that has been published in online articles by the authors of the recent letter. Overall, the BPS concludes that it believes that the contribution of psychologists in response to the pandemic was entirely consistent with the BPS code of ethics and conduct, demonstrating social responsibility and the competent and responsible employment of psychological experience.

Health and Care Bill

Lord Kamall Excerpts

Lords Hansard - Part 1 & Committee stage
Wednesday 9th February 2022 Lords Chamber

Relevant documents: 15th, 16th and 19th Reports from the Delegated Powers Committee, 9th Report from the Constitution Committee

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

My Lords, I should like to update the House on a matter that has generated significant concern. I have noted the strength of feeling in the House on the issue of, and draft guidance on, elected councillors being appointed to integrated care boards. I discussed this matter with NHS England and can confirm that it will revise its draft guidance to remove the proposed blanket exclusion of local authority members sitting on integrated care boards. I am informed that, although ICB members from local authorities are normally likely to be officials, local councillors will not be disqualified for selection and appointment to an integrated care board.

I welcome this development and hope that it demonstrates that the department and NHS England are actively listening and responding to scrutiny and debate in this House. I have also informed the noble Baroness, Lady Thornton, and asked for a meeting between the Labour Front Bench and NHS England on its preparations.

[Lord Kennedy of Southwark (Lab Co-op)]

I thank the noble Lord for that information. Before we continue with the Committee on the Bill, I wanted to raise my concerns on the Floor of the House as to the importance of always treating each other with respect and courtesy. It is not the fault of anyone in this House that despite a majority of 80 in the other place, the Government have taken longer than expected to present several Bills to this House for our consideration. Although backed by the other place—I fully accept that—the Bills are very controversial in nature and quite properly attract considerable attention.

On a few occasions when considering the Nationality and Borders Bill last night and into the early hours of the morning, our standards slipped. We have another long day ahead of us today and another tomorrow before we all have a well-deserved break in the Recess. I hope that Members on all sides of the House, no matter what position they hold, will respect and pay proper attention to the advice and guidance as set out in the Companion. Committee is a conversation, different from both Question Time and Report. Shouting “question, question, question” from a sedentary position is unacceptable in Committee. Chapter 4 on the conduct of the House and Chapter 8 on Public Bills in the Companion are helpful and informative. I respectfully suggest that all Members regard it as essential reading.

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[Baroness Wheeler (Lab)]

My Lords, very briefly, we welcome the Government’s proposals on mandatory disclosure of payments, a companion piece to the previous debate that we had, as has been pointed out.

As noble Lords have always stressed, greater transparency is highly desirable and a very good thing. I am grateful to the Minister for listening to the voices of stakeholders and parliamentarians on this. Indeed, nine out of 10 medical professional bodies think that patients have a right to know if their doctor has financial or other links with pharmaceutical or medical device companies and they support stronger reporting arrangements, as contained in the amendments. I am grateful for the briefing I have received from the ABPI, which, as we have heard, also supports mandatory disclosure.

I also note that Amendment 312D refers specifically to the consultation with the devolved Administrations in Scotland, Wales and Northern Ireland and to obtaining the

“consent of the Scottish Ministers, the Welsh Ministers or the Department of Health in Northern Ireland … before making provision within devolved legislative competence in regulations relating to information about payments etc to persons in the health care sector.”

We would welcome the Minister reassuring us that full consultation is under way and setting out the timescales involved.

On Amendment 284, the non-government amendment leading this group, the intention of the amendment and the arguments put forward by noble Lords are extremely persuasive. The requirement for companies involved in the production, buying or selling of pharmaceutical products or medical devices to publish any payments made to teaching hospitals, research institutions or individual clinicians is a sensible measure that would complement the Government’s package, and I await the Minister’s thoughts on it, including on the one glitch underlined by the noble Baroness, Lady Cumberlege, on moving from “may” to “shall”.

[Lord Kamall (Con)]

My Lords, I thank all noble Lords who took part in this debate, especially my noble friend Lady Cumberlege for her work on the independent review of medicines and medical devices, and other noble Lords who were involved in that. I know that she worked tirelessly to make sure that patients and their families have been heard and I pay tribute to her and her team. I also thank her for her lobbying—or reminding—me of the pledge that I made when I first became a Minister on championing the patient.

I welcome my noble friend’s amendment to increase transparency and promote public confidence in the healthcare system. The Government fully support the intention behind the amendment. That is why I will be moving Amendments 312B, 312C, 312D, 313B, 313C and 314ZB in my name. Before I do so, let me answer some of the questions.

All these amendments relate to the transparency of payments made to the healthcare sector. The Independent Medicines and Medical Devices Safety Review led by my noble friend Lady Cumberlege listened to the brave testimony of over 700 people to understand where improvements needed to be made to make the healthcare system safer for all patients, especially women. The Government have given the review deep consideration and accepted the majority of its nine strategic recommendations and 50 actions for improvement.

To improve transparency, the review recommended that

“there should be mandatory reporting for pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians”.

The amendments deliver on this recommendation by enabling the Secretary of State to make regulations requiring companies to publish or report information about their payments to the healthcare sector. The clause covers any person performing healthcare as part of their duties, benefiting patients and building on initiatives by regulators and industry. I hope that partly answers the questions raised by the noble Lord, Lord Stevens.

The amendment also allows for the Secretary of State to make regulations requiring that the information be made public and make further provision about when and how the information must be published. This could include requiring self-publication or publication in a central database. That ensures that we can adapt the system to improve reporting as necessary. To ensure that companies fulfil the obligation, requirements introduced by the regulations can be enforced using civil penalties.

There are benefits to this duty applying UK-wide, aligning with the approach taken by the pharmaceutical industry with its Disclosure UK system. As the noble Baroness, Lady Wheeler, referred to, the clause contains a statutory consent requirement, so we will work closely with the devolved Governments to develop regulations following the passage of the Bill. We will also work with patients, industry and healthcare providers to create a system that enhances patient confidence while maintaining a collaborative, world-leading UK life sciences sector.

A question was raised about the issue of “shall” versus “may”. The Government have not tabled these amendments in bad faith; we would not have tabled these amendments if we did not intend to work with them. It is the intention of my right honourable friend the Secretary of State to bring forward regulations under the clause to make sure that there is transparency. If that is not reassuring enough, perhaps between this stage and Report there can be some conversations to make sure that noble Lords are assured. It is for these reasons that I ask your Lordships’ Committee to support these amendments.

[Lord Patel (CB)]

Can the Minister confirm what he just said: that it is the intention to bring regulations? How strong is that intention? The “may” creates a problem.

[Baroness Bennett of Manor Castle (GP)]

My Lords, can I add a question about timeframes to that? When can we expect the regulations?

[Lord Kamall (Con)]

I have two points to make to the noble Lord. First, I have been advised that this is standard wording. Secondly, I have made the assurance at the Dispatch Box. It is here; it is on public record that the Government intend to bring forward regulations. On the timeframe, I will either write to noble Lords or arrange a follow-up meeting. I will make sure that there is some communication to bridge that gap.

[Baroness Cumberlege (Con)]

My Lords, I thank everybody who has taken part in this debate, particularly my noble friend the Minister for the work he and his officials have done to bring this into the Government’s remit. That is so important, because I learned through the passage of the Medicines and Medical Devices Act that we could incorporate the patient safety commissioner and some of the other things we wanted to achieve only through government amendments. My heart leaped when I saw these amendments and I thank the Minister.

I still think these amendments could be improved and it is important that we get the word “shall” in, or “might” or whatever others have said, rather than “may”. I was looking at the Oxford English Dictionary. My father-in-law was the publisher to the Oxford University Press, so the dictionary is very close to my heart. The dictionary says that the verb “shall” relates to the right or sensible thing to do, whereas the verb “may” is defined as a possibility.

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[Baroness Merron (Lab)]

My Lords, I thank my noble friend Lady Chakrabarti for raising the crucial matter of countries and peoples left behind in terms of the opportunity to have a necessary vaccination programme available to them. My noble friend Lord Campbell-Savours spoke of the importance of supporting innovation, which is one of the ways in which we can ensure that, while my noble friend Lord Howarth rightly said that the subject requires exploration outside of the Health and Care Bill—something also commented on by the noble Lord, Lord Crisp, who emphasised, as do I, the need for the political will to make progress.

There is no doubt, as we have heard today, about the gravity of the issues at stake and the need to resolve them. It is the case that where public funding is provided there must be conditionality, although of course that may be complex to refine into legislation. There are of course additional issues when funding is also coming from the private sector along with a need to ensure a balance of interests. It would certainly be helpful to have a stipulation that avoided placing undue bureaucracy and restraint on smaller developments and small-scale research. We do not want to see the pace of research slowed down with researchers tied up in lengthy proposal writing, contract negotiations and legal agreements.

As my noble friend Lady Lawrence has said, we know that the pandemic is not over until it is over everywhere, so the amendment raises the opportunity to explore whether the immediate waiver of intellectual property rights would mean an end to the pandemic everywhere. It is relevant to assess what contribution or otherwise intellectual property rights make to the promotion of technological innovation and the transfer and dissemination of technology. There is an advantage for producers and users of technological knowledge and the consideration of rights and obligations, and that needs to be considered in the round.

In respect of the response and actions to a pandemic declared by the World Health Organization, while I understand the intention behind the amendment, in order to be consistent I would comment with some caution about the Secretary of State being compelled to immediately take actions, particularly without any form of oversight—something that we will return to later in Committee.

However, I hope that today we can obtain some reassurances from the Minister about the Government’s intentions and plans in order that we can find a way forward so that low-income countries and their peoples have access to vaccines both now and in future.

[Lord Kamall (Con)]

I thank the noble Baroness, Lady Chakrabarti, for bringing this debate before the Committee today and for the heartfelt speech that she gave. The noble Baroness will be aware of the view of this Government following her recent Question in the House on the subject of patient waivers. As my noble friend Lord Grimstone set out, the Government remain open to all initiatives that would have a demonstrably positive impact on vaccine production and distribution. However, we believe that waiving intellectual property rights would have the opposite effect. Doing so would dismantle the very framework that helped to develop and produce Covid-19 vaccines at the pace and scale now seen. It would risk undermining the continued innovation in vaccines and technological health products that is required to tackle a virus, especially as it mutates and evolves, so we believe that doing so would be a mistake.

Instead, the success of the Covid-19 vaccine rollout vindicates the value of public and private co-operation. While university research departments are great at research, large-scale manufacturing and global distribution are not their function, so we recognise the importance of their working with partners with expertise in this area.

The intellectual property framework is key to those efforts. It has incentivised the research and development that has led to the development of Covid-19 vaccines. It has given innovators the confidence to form more than 300 partnerships, an unprecedented number, and has contributed to the production and dissemination of vaccines and other health products and technologies across the world, with global Covid vaccine production now at nearly 1.5 billion doses per month.

I share the noble Baroness’s intention that research funded through taxpayer finances should benefit the taxpayer, but we do not consider that that is best achieved through particular constraints in primary legislation. Research contracts afford greater flexibility and more powerful levers than the amendment, through provisions such as those requiring the dissemination of intellectual property for patient benefit, revenue sharing with the Government of commercialised intellectual property, and requirements around access to medicines in the developing world. Contractual protection mechanisms in funding arrangements can also ensure that intellectual property funded by taxpayers results in the creation of taxpayer benefit.

[The remainder of today’s proceedings will be published tomorrow.]

Health and Care Bill

Lord Kamall Excerpts

Committee stage
Wednesday 9th February 2022 Lords Chamber

[Baroness Jones of Whitchurch (Lab)]

My Lords, I intend to be brief because we do not believe that these two amendments are either necessary or appropriate in the context of the Health and Care Bill. If the Equality and Human Rights Commission is conducting a wider review into single-sex services then we should consider those issues at that time, but not in the context of this Bill.

I agree with the noble Baroness, Lady Brinton, that the Equality Act 2010 and the 2019 NHS guidance Delivering Same-Sex Accommodation already provide an effective mechanism for inclusion in the context of single-sex wards. The two amendments seek to cut across long-standing provisions in both the Act and the guidance. There is no substantial evidence to suggest that the status quo is not working and that NHS professionals are unable to use the existing guidance, which clearly sets out the principles and practice to be followed.

We also consider that the amendments could do harm if implemented, because they would create a blanket rule requiring trans women to be treated on men’s wards and trans men to be treated on women’s wards. At best, that would create an environment contrary to the dignity and well-being of the patients. At worst, it would leave trans patients at the risk of harm and abuse by outing them in a public context at a time when they are particularly vulnerable.

Like other noble Lords, we have received a detailed briefing from Stonewall imploring us to oppose these amendments. Given that we do not consider that the Bill is the right place for the consideration of these issues, we will not be lending our support to the amendments.

[Lord Kamall (Con)]

My Lords, I am grateful to my noble friend Lord Blencathra for bringing this discussion before the Committee and to my noble friend Lady Nicholson for taking the time to meet to discuss this issue, on which she is a strong advocate.

It clearly arouses strong feelings, but it is really important that we remember two principles: dignity and respect. There are people who feel they were born in the wrong body, and we should respect their rights as trans men or trans women; at the same time, there will be some women in wards who, on seeing someone who, to them, seems like a man, may feel slightly vulnerable at a particularly vulnerable time—in hospital. It is right that we get the right balance.

I hope noble Lords will be aware that NHS England is currently reviewing the Delivering Same-Sex Accommodation guidance to ensure that it remains focused on privacy, safety and dignity for all patients. The NHS is committed to meeting its duties under the Equality Act and, as such, needs to give due regard to both those whose gender identity is the same as their biological sex at birth and those whose gender identity is not. This means that the rights and needs of women and trans women are equal in law.

Following the review, the new content of the guidance will be informed by engagement with a wide range of stakeholders and by the statutory duties of the NHS outlined in the Equality Act 2010, including the public sector equality duty. NHS England is currently under- taking this review and is fully aware of its importance. The guidance, which will be updated if appropriate, is due to be published later this year. I call on noble Lords not to pre-empt the outcome of the guidance review. Any guidance will—indeed, must—be compatible with the requirements and duties placed on NHS bodies by the Equality Act 2010.

I am aware that concerns have been raised about the safety of women in single-sex wards. We, as a Government, believe that violence of any kind has no place in NHS facilities. We expect that hospital staff will act in the best interests of all patients and can, if necessary, call on security staff and law enforcement to ensure that everyone is safe. I repeat my request to my noble friend Lady Nicholson for evidence of such cases, whether it be women who feel uncomfortable or patients or staff who have raised concerns and been accused of being transphobic. If that is the case, I ask her to bring these cases to my attention and we can look at them further.

However, given that NHS England is currently reviewing the guidance, I hope noble Lords can appreciate the need to allow it time to review it in full. I ask the noble Baroness to withdraw her amendment.

[Baroness Nicholson of Winterbourne (Con)]

I thank the Minister very much for his immensely helpful statement, while reminding him that the rights of another group do not supersede the rights of the group that is already there. In other words, it is not really worth listening to the simple comment, “Women and trans women are equal”. We are all equal under the law; we all have dignity and equal rights. My contention is that the dignity, privacy and safety of women patients, which have been fought over for several decades in both Houses, are now being diminished significantly and their health and recovery from illness significantly undermined by the imposition of new rights of others on top of women’s rights. It amuses me that no one is suggesting they should be on top of men’s rights.

This is, I am afraid, a matter of great concern to all women. I know that Members of other Benches have demanded evidence. I can guarantee that, within 24 hours, if you wish it, I can get 20,000 to 40,000 letters in front of the Minister claiming that women need privacy, safety and dignity, and that they are not receiving it with these new impositions. If noble Lords want evidence, feel free.

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Moved by

[Lord Kamall]

312: Clause 111, page 98, line 19, leave out from “provision” to the end of line 23 and insert “—
(i) would be within the legislative competence of the Northern Ireland Assembly if contained in an Act of that Assembly, and(ii) would not, if contained in a Bill for an Act of the Northern Ireland Assembly, result in the Bill requiring the consent of the Secretary of State under section 8 of the Northern Ireland Act 1998.”Member’s explanatory statement
This amendment makes a drafting change to reflect the fact that consent of the Secretary of State under section 8 of the Northern Ireland Act 1998 is given in relation to an Assembly Bill rather than an Assembly Act.

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Moved by

[Lord Kamall]

312B: Before Clause 81, insert the following new Clause—
“Information about payments etc to persons in the health care sector
(1) The Secretary of State may by regulations require manufacturers or commercial suppliers of health care products, or connected persons, to—(a) publish information about payments or other benefits provided by them to relevant persons, or(b) provide such information to the Secretary of State.(2) The regulations may make further provision about when and how the information is to be published or provided.(3) The information may, in particular, include information about—(a) a payment or other benefit,(b) the person who provided it, or(c) the person who received it.(4) The regulations may make provision permitting or requiring the further sharing, publication or use of the information.(5) The regulations may impose requirements on manufacturers or commercial suppliers of health care products, or connected persons, about the retention of information relating to payments or other benefits provided by them to relevant persons.(6) The regulations may—(a) authorise the Secretary of State to designate as a “relevant scheme” any scheme under which information about payments or other benefits to relevant persons is collected or published by a person other than the Secretary of State, if the Secretary of State considers that the provision of information under the scheme would render compliance with some or all of the requirements imposed by the regulations unnecessary;(b) create exceptions from requirements to publish or provide information imposed by virtue of subsection (1) where information is provided under a relevant scheme;(c) if such exceptions are created—(i) require a person who holds information mentioned in subsection (1) in connection with the operation of a relevant scheme to provide the information to the Secretary of State;(ii) permit or require the Secretary of State to publish the information.(7) The regulations may impose requirements on a person mentioned in subsection (6)(c)(i) about the retention of information mentioned there.(8) The provision for exceptions that may be made by the regulations includes provision authorising the Secretary of State to grant an exception from a requirement imposed by the regulations in a particular case, on grounds specified in the regulations. (9) The regulations may provide that the disclosure of information under the regulations does not breach—(a) an obligation of confidence owed by the person making the disclosure, or(b) any other restriction on the disclosure of the information (however imposed), other than a restriction imposed by the data protection legislation.(10) Provision made by the regulations may, in particular, be framed by reference to manufacturers or commercial suppliers with a specified connection to the United Kingdom or a part of it.(11) In this section—(a) “connected person”, in relation to a manufacturer or commercial supplier, means a person who has a connection, of a description specified in regulations made by the Secretary of State, with the manufacturer or commercial supplier;(b) “relevant person” means—(i) a person who provides health care in the United Kingdom or a part of it, whether or not under arrangements made by another person, or(ii) another person who carries on activities connected with health care provided in the United Kingdom or a part of it and is of a description specified in regulations made by the Secretary of State.(12) In this section—“commercial supplier”, in relation to a health care product, means a person who supplies the product otherwise than in the course of providing health care;“data protection legislation” has the meaning given by section 3(9) of the Data Protection Act 2018;“health care” means all forms of health care provided for individuals, whether relating to physical or mental health;“health care product” means a medicine, medical device or other product which is supplied or prescribed in the course of the provision of health care;“manufacturer”, in relation to a health care product, means a person who manufactures or assembles the product;“payments or other benefits” includes any payment or other benefit—(a) wherever it is provided,(b) whether or not it is of a financial nature,(c) whether it is provided under a contract or otherwise, and(d) whether it is provided directly or through a third party.”Member’s explanatory statement
This New Clause would enable regulations to require the reporting and publication of information about payments and other benefits provided to persons in the health care sector by manufacturers and suppliers of health care products.

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[Baroness Jones of Whitchurch (Lab)]

My Lords, I will respond to the debate, but my comments apply equally to the next group, so I hope that the noble Baroness, Lady McIntosh, will forgive me if I do not respond to that group separately. We have heard some very thoughtful and persuasive contributions to the debate on these amendments this evening, and once again my noble friend Lord Hunt and the noble Lord, Lord Clement-Jones, have very eloquently led the charge. I congratulate them on their contributions and the constructive detail of their proposals. Issues such as this require some specific proposals to have any meaning and their amendments very much do that: they spell out some solutions to the challenges we face. I also welcome the specific proposal from the noble Baroness, Lady Tyler, who made the case well for a single identifier for children.

The underlying issues around the use of information collected by the NHS are not new. As we know and have heard, the NHS is almost unique in being a single player in this field, at least for some purposes. It can and often does lead the world in its ability to collect and aggregate patient data to drive improvement and for other non-profit-making purposes.

Since the organisational changes of the 1990s, data collection and use have been well developed, and information and analysis—for example, from the Secondary Uses Service and some GP sources—have been extensively used by academics and researchers, as well as operational managers, to huge public benefit. But we have struggled, as we have heard. Despite hugely expensive meanders into, for example, the National Programme for IT, we are far from the goal of integrated data sharing, even in a single hospital, let alone all hospitals, let alone for all care. Clearly, technical, legal and cultural barriers need to be overcome before we can maximise the use of all the data collected.

As noble Lords have pointed out, the groundswell of opposition to data collection and the related concerns about who gets to use it and for what purposes runs along these barriers. We know that the NHS often has dismal communications—for example, around CareCo and the recent changes to the use of GP data, which we have heard about this evening.

Although we do not own our data, there is a very powerful set of legal protections over what data can be collected and stored about us and what it can be used for. If the public had absolute confidence in the systems and usage rules, there would be far fewer objections to their information being used to drive improved healthcare, innovative drugs research or better preventive or public health information programmes. But the reality is that concerns are widespread—about data breaches, about NHS data reaching people who do not need to see it and, more recently, as we have heard, about data being used by a number of unethical organisations and private companies to drive profitability rather than for the improvement of public health.

Many patients would wish to be able to refuse to allow data collected about them to be used simply to drive a better marketing campaign for slimming or cosmetic aids but would allow their data to be aggregated so that better drugs could be developed and treatments improved to save lives; that would be an altogether different matter. Amendment 305A, in the name of my noble friend Lord Hunt, on establishing a sovereign health fund to invest in data-driven healthcare assets to generate long-term income for health and care makes that point, and I am sure it would have public support.

The key principle should be that all data collected for the purposes of care should be held and controlled by the public sector and its use protected. It should be subject to ethical guidelines and independently verified by an expert oversight group. These amendments would strengthen these rights in those regards.

Anyone who visited a hospital 20 years ago and walked around would probably have come across a trolley stacked with files that could easily have been removed or read. However, IT and the ability to aggregate vast amounts of data, allowing serious data breaches, is a modern and valid concern. My noble friend Lord Davies illustrated this with specific concerns about smart programmes which can identify individual people from a very small amount of data about their lives.

So we do feel that these amendments would be a very helpful way to address the underlying and fundamental problems of the lack of patient and public confidence in how their data is going to be used and shared. I hope the Minister, the noble Baroness—no, it is the noble Lord—agrees that these proposals offer a helpful way forward in addressing these concerns. While we will not press the amendments to a vote this evening, I hope he is able to offer some reassurance that some of these practical proposals will be taken forward by the Government.

[Lord Kamall (Con)]

Let me assure the noble Baroness that I was not trying to opt out of my duty to respond.

I thank all noble Lords for their contributions to this important debate. I reassure many noble Lords across the House that when I first became a Minister, I had many of these questions myself—and I continue to have them, if I am perfectly honest.

I will turn first to the amendments before deciding how to go forward, as it were. In response to Amendment 298, Clause 81 explicitly mentions NHS England as a body to which mandatory information standards can be applied. As set out in this clause, the exact procedure for publishing information standards, as well as any procedure for granting waivers in respect of compliance with these standards, will be set out in regulations subject to parliamentary scrutiny under the affirmative procedure. The regulations may set out limits on the circumstances in which a waiver may be granted. For example, a temporary waiver might be considered where an organisation does not have funding in place to implement the required changes.

The noble Lord, Lord Hunt, also referred to accredited data access environments and rightly acknowledges that their function is not just to support research but for analysis to support service planning, as well as other essential activity. I believe that we are fulfilling our promises to the profession and the public at the moment, but clearly more could be done. We have made clear that data collection for General Practice Data for Planning and Research will now begin only when: first, we have in place the ability to delete data if patients choose to opt out of sharing their GP data with NHS Digital; secondly, a trusted research environment is available, where approved researchers can work securely on deidentified patient data; and, lastly, a campaign of engagement and communication has increased public awareness, explaining how data is used and patient choices.

In addition, the Government have committed to developing, this year, rules for such data environments in the NHS, including technical specifications and a framework for accreditation. However, while we expect secure data environments to be appropriate for the vast majority of uses, there are likely to be exceptions. For example, where patient consent has been given for data to be made available to an external researcher or organisation, or where there is a court order requiring data, it may have to leave the secure data environment. I assure the noble Lord that we will continue to examine how secure data environments operate and are governed, to make sure that they are fit for the future.

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[Lord Warner (CB)]

I am sorry to interrupt the Minister at this time of night, but I think he has no idea how many Ministers have stood in this place over the last 10 to 15 years making very similar speeches to this. We now have “deep dives”, but the idea of Whitehall co-operating on this issue is always dead in the water after these deep dives, if I may mix my metaphors. What we really need is at least an assurance that some kind of pilot scheme will actually emerge from this deep diving and be put in place so that something actually happens, with all the agencies co-operating.

[Lord Kamall (Con)]

I thank the noble Lord, first for his earlier confidence in my abilities and now for questioning my abilities, as it were, and rightly so. I am very interested in this, and noble Lords will remember that, in the meeting, I discussed what I saw as technical solutions to this. If there are different primary keys, it does not take a complicated bit of code to give equivalence or, in fact, restricted views, as it were, as appropriate. However, once again, those views would have to be agreed across government: while it might seem appropriate for the Department of Health number or the NHS number to be used, that could give access that is not considered appropriate, and we have to get the right balance. I ask the noble Lord, Lord Warner, to revert back to his earlier confidence in my abilities to do something —assuming I am here for some time.

In the coming months, the Department for Education will be providing an update to the existing information-sharing guidance. We believe that provides a real opportunity. One thing I have been quite clear about—for example, in the life sciences vision—is that I want to work with my counterparts and have been working with my counterparts in other departments; in BEIS, in DIT but also with the adviser in No. 10. I fully recognise the Committee’s interest in promoting data protection, ensuring that patients’ data is used appropriately. We have all been on a learning curve over the years as people share their data on such things as Facebook and now realise what happens to that data, how it is used and sold. I alhso refer to the ownership of data: at the end of the day, the data has to be the patient’s data. They have to be quite clear about that ownership and what happens to it.

All processing and sharing of information under Clauses 81 to 87 will meet the requirements of data protection law, including the UK GDPR. An individual’s personal information will be shared only in specific circumstances: where the individual consents to the use of the data, where there is a legal requirement to share or where sharing such data is necessary. I recognise as well that noble Lords, if we get through this, will be having a meeting tomorrow on confidential data and I hope that we can have some more, deeper conversations, not only tomorrow but in future. I have committed previously to meetings: there is a particular issue with one of the meetings and I will explain that to the noble Lords I spoke to previously about it, but I hope that for now, noble Lords will have some reassurance, although perhaps not complete reassurance, and will feel able to withdraw their amendments at this stage.

[Lord Hunt of Kings Heath (Lab)]

My Lords, I am very grateful to the Minister. I am conscious of what my noble friend Lord Davies said about the time we have to debate these complex and important matters. Clearly, we would like to reflect on the Minister’s reply, which was constructive and helpful, although I cannot help recalling meetings that I held as a DoH Minister with the Department for Education Ministers in about 2002, where we were discussing this very issue. My noble friend Lady Hughes—Beverley Hughes—was the Education Minister and, alas, nearly 20 years later, here we are still talking about these issues, which is why we are a little pessimistic about the dive that the noble Lord is about to make.

In the end, this is all about public confidence and the balance between the needs of our health and care system and the benefit that accrues from the exchange of, and access to, information. I am alarmed by the figure for opt-outs—a million—and it puts at risk the integrity of having the shared information system. That is a reflection of the challenge that the NHS in particular faces and I still doubt whether it really recognises just what it needs to do. Making opt-out easier is one way in which we build confidence in the system, and it might mean that fewer people opt out in the future. The current system of making it as hard as possible for people to opt out is not the way to grow confidence. That is probably the most important point that I want to make.

Having said that, I thank the Minister for his constructive response, and we look forward to these further meetings. I beg leave to withdraw the amendment.

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[Lord Clement-Jones (LD)]

My Lords, I rise very briefly to speak to this amendment. I have considerable doubts about it. In relation to patient data, it looks like a possible thin end of a wedge—in fact, it might even be the thick end of a wedge.

I take this opportunity to come back to the Minister to add a query about the data governance regime which he has described this evening and into which we dipped our toe with the last group of amendments. My noble friend anticipated me in discussing the White Paper, which, in turn, follows from the Data Saves Lives draft strategy. I hope we will have the opportunity to meet the Minister to discuss this further because it is a very complex area.

I want to add to that conversation the fact that we variously have IGARD, CAG and the National Data Guardian for Health and Care—as well as NHS Digital, which we hope will remain separate, but we will come to that shortly. We have all these different bodies, but we need a simple regime which helps us understand, for instance, whether the Minister will say, “Yes, it’s already happening”, to the noble Baroness, Lady McIntosh, or, “No, it’s not going to happen.” I could not tell you the answer to that question in my current state of knowledge about the ability to transfer information across the health service and internationally.

There is a balance to be struck between the established protections and new provisions which might expedite the development of access to new and improved treatments and technologies—but it must be done in a safe way. I hope that, between Committee and Report, the Minister will take the opportunity to ensure that we have all the information we need on plans to perform a so-called reset of or new direction for—or however he might like to describe it—the NHS’s use of our health data.

[Lord Kamall (Con)]

I am grateful to the noble Baroness, Lady McIntosh, for bringing this discussion before the Committee. I also thank the noble Lord, Lord Clement-Jones, for his contribution. The information collected by the future medicine information systems has the potential to be used appropriately to support relevant research and improve the way in which we monitor medicines across the UK. However, once again, referring to the previous debate, we must be quite clear about whose data that is and the right to opt out.

Exchanging information with both national and international institutions is already integral to the MHRA’s post-market surveillance activities. Appropriate sharing of data from medicine information systems and medicine registries could also help support wider research to directly inform regulatory decision-making and to further support patient safety. Once again, we must respect patients’ concerns and their right to opt out.

The clause already provides the necessary power, by inserting new subsection (7A)(2)(c), enabling regulations to be made about the use and disclosure of information held within medicine information systems.

In regard to the noble Baroness’s admirable desire to ensure international co-operation with other bodies for post-market surveillance, medicines information systems will be established to support the MHRA developing medicine registries. As the regulatory authority, it is the MHRA’s international collaboration, rather than the information centres’, that will be key to supporting post-market surveillance. To ensure that this can continue, there are already specific powers in the Medicines and Medical Devices Act which enable the Secretary of State, and by extension the MHRA, to appropriately share information with international partners. Once again, going back to a previous debate, it is about what is an appropriate sharing of data.

As with medicines information systems, we already have sufficient legal powers to appropriately share. On the second element of this amendment, the existing provisions in Section 19, specifically Section 19(2)(c), enable regulations to address the use and disclosure of information held within medical devices information systems, providing an ability to appropriately share information within a future system. There will need to be careful consideration and consultation on the sharing and use of information, as we have previously said. However, there is a beneficial impact that the system could have in research and post-market surveillance.

In response to the specific question, I recognise the desire to see a system set up under the regulation-making powers in place, but given the importance of this matter, it is crucial—I hope that the noble Baroness reflects on the previous debate—that we take the time to get this right. Any regulations made under Section 19 and the wider system will need to be informed by extensive engagement and consultation, working closely with our partners in the devolved Administrations, so that they can deliver their full potential for patients and clinicians across the UK, taking account of the very real concerns raised about patient data. Once again, we are trying to get that balance right: better healthcare and better research feeding into health, but at the same time patients having the right to opt out.

NHS Digital is well placed to deliver and operate the medical devices information system. Alongside key partners, such as the devolved Administrations, we will consider how we can establish this system in a controlled, staged manner that builds on the confidence and momentum behind this issue.

Finally, I will be moving Amendment 306AA in my name. The amendment is supported by the Scottish Government; it is simply a clarification in wording. It makes clear that any powers or duties conferred on Scottish Ministers in relation to their role in collecting information for medicines information systems can be treated in the same way as other NHS powers or duties in Scotland and be delegated to health boards in Scotland. It is my sincere intent not only to respect the devolved settlement but to create the best possible system, one that will work UK-wide. This amendment supports that aim. It is for that reason that I ask noble Lords to support this amendment and invite my noble friend to withdraw hers.

[Baroness McIntosh of Pickering (Con)]

My Lords, I am grateful to my noble friend the Minister and the noble Lord, Lord Clement-Jones, for their contributions. I quite understand that my noble friend feels that there has to be a proper consultation, mindful of the sensitivity of patient data. I remember that being discussed during the passage of the Medicines and Medical Devices Bill in this place. It would be helpful to have an idea of what the timetable is for the consultation period and the introduction of the regulations. I do not know if my noble friend is able to put a timetable on that. Perhaps he could do that when we meet at the round table; it would be extremely helpful.

I am grateful for the reassurance he has given and for the opportunity to have aired the issues this evening. At this stage, I beg leave to withdraw the amendment.

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Moved by

[Lord Kamall]

306AA: Clause 87, page 80, line 40, at end insert—
“(b) provide for powers or duties conferred on the Scottish Ministers to be treated for the purposes of section 2 of the National Health Service (Scotland) Act 1978 as functions relating to the health service (within the meaning of that Act).”Member’s explanatory statement
This amendment enables the Scottish Ministers to delegate functions conferred on them under medicine information systems regulations to certain health bodies in Scotland.

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[Lord Kamall (Con)]

My Lords, as many other noble Lords have said, this group contains a range of amendments in relation to the power to transfer the functions of the arm’s-length bodies. Because some of the bodies within the scope of this power perform functions in areas of devolved competence, Clauses 88 to 94 engage the legislative consent process. To ensure that we can proceed on a UK-wide basis, the Government have agreed to make a number of amendments, while recognising the comments of the noble Baroness about support for those amendments. Following the recent conclusion of our negotiations with the devolved Governments, I am pleased that they have now recommended to their respective legislatures that legislative consent Motions be granted provided that these amendments are accepted.

Amendments 231A and 231B will remove devolved Ministers, the Northern Ireland Department of Health and Welsh NHS trusts from the list of appropriate persons to whom property rights and liabilities can be transferred through a transfer scheme, following a transfer of functions. Following a request by the devolved Governments, we determined that it would not be necessary for such a transfer to those entities to occur.

Proposed Amendment 231C creates a requirement for the Government to obtain the consent of the devolved Governments for any transfer of functions that are within the competence of their legislatures or that modify functions exercised by Welsh Ministers, Scottish Ministers or a Northern Ireland department. While the majority of the functions within the scope of the power relate to reserved matters or apply in England only, certain bodies have functions that meet the criteria laid out above. This requirement to obtain the consent of devolved Ministers replaces the requirement to consult them. The Secretary of State will still be required to consult any body to which the regulations relate and can consult such other bodies as the Secretary of State deems appropriate. A memorandum of understanding is currently being finalised that sets out how the devolved Governments will be engaged from an early stage of policy formulation.

Amendments 231D to 231G are consequential on the changes to Clause 94 made by Amendment 231C. We have also agreed with the Welsh Government to make Amendment 227A, which clarifies that the powers in Part 3 of the Bill apply only in relation to England-only and cross-border special health Authorities and not Wales-only special health authorities. It has never been the Government’s intention for references in Part 3 of the Bill to special health authorities to include Wales-only ones. This amendment simply makes that explicitly clear.

I would also like to provide some reassurance to the devolved Governments about Clause 91(6), which sets out that the consequential provision that may be made when making regulations to transfer functions includes consequential changes to devolved legislation. The reason this is necessary is that there are references to the relevant arm’s-length bodies in devolved legislation that may need to be amended to reflect a transfer of functions or the renaming of a body. Amendments to devolved legislation under this power may be made only if they genuinely flow from a transfer of functions. This is not a broad power to make sweeping substantive changes to devolved legislation.

In a similar vein, we want to provide assurance to the devolved Governments about Clause 149, which is a wider power to enable the UK Government to make consequential amendments that may be necessary following the passage of the Bill. This type of power is quite common in a Bill as large as the Health and Care Bill and there are many examples of similar powers in legislation already on the statute book. Amendments, including amendments to devolved legislation, under this power may be made only if they are genuinely consequential upon provisions within the Bill. Like Clause 91(6), this is not a broad power to make sweeping substantive changes to devolved legislation.

I now turn to Amendments 229 and 230 relating to Clause 91 that have been spoken to by the noble Lord, Lord Patel. Clause 91 does not create powers in and of itself. Rather, it sets out certain types of provision that may be made when the Secretary of State uses the power to make consequential provision where making regulations under the Bill—Clause 150—alongside the power to make regulations under Clauses 89 or 90 transferring or delegating functions. Anything done under the powers to which this clause relates, therefore, would need to be genuinely consequential, supplementary or incidental to a transfer or delegation of functions.

It is impossible to predict every consequential provision that may arise from a transfer of powers and functions. Therefore, it is appropriate that the list in Clause 91(1) should be non-exhaustive, and include provision for abolishing and changing functions, as well as conferring them. Any changes would be made under the affirmative procedure, allowing Parliament to scrutinise them, and I hope the noble Lord will feel that he does not need to press his amendments.

I turn now to Amendment 227 and 228, tabled by the noble Lord, Lord Hunt, and spoken to by the noble Lord, Lord Clement-Jones. The merger of NHS Digital and NHS England was a recommendation of the Wade-Gery review. The aim is to give NHS England overall accountability for leading the transformation of digital services in the NHS, which includes how we use data effectively and securely.

Years ago, when I did my master’s in information systems management, one of the things we found out about companies or push-back companies was that digital and technology should not be separate or a bolt-on. They should be an integral part of the strategy and NHS Transformation tells me how integral technology is to transformation. If you consider it a bolt-on, it will not be integral to the overall strategy. To quote from Putting Data, Digital and Tech at the Heart of Transforming the NHS:

“data and analytics must become a core capability for NHSEI and the wider healthcare system going forward … Currently, this capability is split across NHSEI, NHSX and NHSD and, as a result, is being underutilised with duplicated activities, investments and capabilities.”

The report makes clear the benefits of these proposed changes.

There is also no question of diluting the current patient data protections. The planned merger will largely be achieved through a transfer of functions, staff, services and platforms from NHS Digital to NHS England. The Government will continue to hold NHS England to account for delivery of these functions, just as it currently holds NHS Digital to account. None of the changes we are making will remove the protections in respect of patient data.

I thank the noble Lord, Lord Warner, and the noble Baroness, Lady Walmsley, for for moving their amendment into this group. Placing these kinds of constraints on the Government’s power to commence legislation would be both unusual and counterproductive; we believe that our elective recovery delivery plan, which was announced yesterday, is better suited to solving the issues in this debate. We have committed an additional £2 billion this year, plus a further £8 billion, and laid out how we expect to tackle the backlog. As the noble Baroness, Lady Merron, rightly said, there was a backlog before, and we would have been tackling it earlier had it not been for Covid. We intend to deliver on our proposals, and those in the 2019 NHS Long Term Plan.

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Moved by

[Lord Kamall]

227A: Clause 88, page 83, line 10, at end insert—
“Special Health Authority” means a Special Health Authority established under section 28 of the National Health Service Act 2006.”Member’s explanatory statement
This amendment makes it clearer that the powers in Part 3 of the Bill apply only in relation to England-only and cross-border Special Health Authorities (and not Wales-only Special Health Authorities).

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[Baroness Walmsley (LD)]

My Lords, the 2012 Act removed certain powers from the Secretary of State, and Jeremy Hunt, the former and longest-serving Secretary of State, says that he never felt the lack of them. He had all the levers he needed to carry out his role of ensuring that the mandate and the five-year forward view were carried out and responsible to Parliament. However, Part 3 of the Bill puts a whole lot back—and more. These powers appear all over the Bill but particularly in Part 3, and we have spent the last five weeks pushing back against most of them.

There is a real danger that, if the Secretary of State were to use these powers, it could threaten the stability, proper management and operational independence of key parts of the NHS. The Constitution Committee raised serious concerns about the range of Secretary of State powers and concluded that the new powers

“could alter the balance between the Government’s constitutional responsibility for the provision of health care and providers’ ability to … respond effectively to local needs.”

I make no apology for the fact that I have quoted this section of the committee’s report before. It applies to so much of the “We know best” power grab that it bears repeating.

If the Minister wishes to abolish, change or transfer functions between arm’s-length bodies to this extent, it should be scrutinised by Parliament. Should it be necessary and appropriate in the future to make these changes, the Secretary of State should find another piece of primary legislation in which to do it. But to take these overreaching powers with no indication of how they will be used—or why—is going too far.

[Lord Kamall (Con)]

I thank both noble Baronesses for bringing this debate before the Committee. The proposal is to remove Part 3 of the Bill entirely. I understand that the noble Baronesses are principally concerned to prevent Health Education England, NHS Digital, the Health Research Authority and the Human Fertilisation and Embryology Authority from being abolished as a consequence of this power.

I clearly understand the concerns in this debate, but I stress that this is not a power to take away services currently being performed by arm’s-length bodies. The power is to enable the transfer of functions between arm’s-length bodies, and the delegation of the Secretary of State’s functions to arm’s-length bodies, to improve consistency and coherence in the arm’s-length body landscape. There is no free-standing power simply to abolish an arm’s-length body contained in this clause, and it is not the Government’s primary intention to use this power to abolish bodies. The only circumstances where a body may be abolished under this power is where it is, as the result of transfers of its functions to other bodies, effectively rendered redundant. To not have the power to abolish such bodies in these circumstances would effectively leave shell arm’s-length bodies with no significant functions, which would weaken the efficiencies we are seeking to create.

I reassure the noble Baronesses that all proposals will be considered through a full and extensive engagement and consultation process. Regulations providing for transfers under this power will be subject to the affirmative procedure. This ensures that Parliament can scrutinise the use of this power, including any necessary amendments made to primary legislation. This would follow on from a consultation with the relevant parties.

The Secretary of State must, at a minimum, consult the arm’s-length bodies and devolved Governments to which the transfer relates. Additional stakeholders whom it may be appropriate to consult will vary depending on the nature of the transfer of functions contemplated. The Bill therefore provides that such other persons as the Secretary of State considers appropriate should also be consulted, which is in line with the department’s and the Government’s commitment to engaging with stakeholders.

We have set out the principles of engagement and consultation with the devolved Governments through a memorandum of understanding, which has been negotiated and is close to agreement. This will sit along- side the legislation and provide the opportunity for the devolved Governments to be involved at a formative stage of policy development. In addition, the principle of Amendment 231C, which we have just discussed, is a requirement for the relevant devolved Governments’ consent to be given to transfer any functions that are within their legislative competence or that modify functions exercised by the devolved Government.

Although the majority of the arm’s-length bodies and functions within the scope of the power relate to reserved matters or apply in England only, certain bodies have functions that meet the criteria laid out above. We all know that the arm’s-length body landscape is complex, and this power will ensure that there is a transparent process throughout, including formal consultation, so that any relevant arm’s-length bodies and devolved Governments, and Parliament, will have the opportunity to scrutinise any plans for its use. I hope that that has given some assurance, and for these reasons I ask the noble Baroness to withdraw her opposition to the clause standing part.

[Baroness Merron (Lab)]

I thank the Minister for his reply and the reference to parliamentary scrutiny. He will know that, in discussions in this Committee, the call for transparency and scrutiny has often been repeated. I am interested in the reassurances that the Minister has given and will consider his points further. I am sure that he understands that there is a feeling that these powers are still not necessary—not now—but I will certainly consider his points. With that, I beg leave to withdraw my opposition to Clause 88 standing part.

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Moved by

[Lord Kamall]

231A: Clause 92, page 87, line 4, leave out paragraphs (c) to (e)
Member’s explanatory statement
This amendment removes the Scottish Ministers, a Northern Ireland department and the Welsh Ministers from the list of persons to whom property etc can be transferred under Clause 92.

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Moved by

[Lord Kamall]

231C: Clause 94, page 88, line 2, leave out subsection (1) and insert—
“(1) Before making regulations under section 89 or 90, the Secretary of State must—(a) obtain the consent of the Scottish Ministers in relation to any provision—(i) which would be within the legislative competence of the Scottish Parliament, if contained in an Act of that Parliament, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or(ii) which modifies the functions of the Scottish Ministers;(b) obtain the consent of the Welsh Ministers in relation to any provision—(i) which would be within the legislative competence of Senedd Cymru, if contained in an Act of the Senedd, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or(ii) which modifies the functions of the Welsh Ministers;(c) obtain the consent of a Northern Ireland department in relation to any provision—(i) which would be within the legislative competence of the Northern Ireland Assembly, if contained in an Act of that Assembly, and is not merely incidental to, or consequential on, provision which would be outside that legislative competence, or(ii) which modifies the functions of a Northern Ireland department.”Member’s explanatory statement
This amendment requires the Secretary of State to obtain consent of, rather than consulting with, the Scottish Ministers, the Welsh Ministers or a Northern Ireland department (as appropriate) before making provision within devolved legislative or executive competence in regulations under Clause 89 or 90.

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Moved by

[Lord Kamall]

313ZA: Schedule 16, page 233, line 2, leave out “(123 or 124” and insert “123, 124, (Offence of carrying out hymenoplasty: England and Wales), (Offence of offering to carry out hymenoplasty: England and Wales) or (Offence of aiding or abetting etc a person to carry out hymenoplasty: England and Wales)”
Member’s explanatory statement
This amendment adds the new England and Wales offences relating to hymenoplasty to section 65A of the Police and Criminal Evidence Act 1984 (qualifying offences for the purposes of Part 5 of that Act).

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Moved by

[Lord Kamall]

313A: After Schedule 16, insert the following new Schedule—
“STORAGE OF GAMETES AND EMBRYOSPART 1AMENDMENTS TO HUMAN FERTILISATION AND EMBRYOLOGY ACT 1990Introductory
1_ The Human Fertilisation and Embryology Act 1990 is amended as follows.Maximum storage periods
2_(1) Section 14 (conditions of storage licences) is amended as follows.(2) In subsection (1), for paragraph (c) substitute—“(c) that the requirements of subsection (3) (maximum storage periods) are met,”.(3) For subsections (3) to (5) substitute— “(3) The requirements referred to in subsection (1)(c) are as follows—(a) gametes must not be kept in storage for longer than such period not exceeding 55 years beginning with the day on which they are first placed in storage as the licence may specify;(b) an embryo must not be kept in storage for treatment purposes for longer than such period not exceeding 55 years beginning with the day on which it is first so kept as the licence may specify;(c) an embryo that is kept in storage for the research or training purpose but not for treatment purposes must not be so kept for longer than such period not exceeding 10 years beginning with the day on which consent was given under Schedule 3 to the storage of the embryo for that purpose as the licence may specify;(d) a human admixed embryo must not be kept in storage for longer than such period not exceeding 10 years beginning with the day on which it is first placed in storage as the licence may specify.(4) Where under Schedule 3 consent is given to the storage of an embryo for the training or research purpose by different persons on different days, the reference in subsection (3)(c) to the day on which consent was given is to be taken as a reference to the last of those days.(5) For the purposes of this section—(a) “treatment purposes” are purposes referred to in paragraph 2(1)(a) or (b) of Schedule 3;(b) the “training purpose” is the purpose referred to in paragraph 2(1)(ba) of that Schedule;(c) the “research purpose” is the purpose referred to in paragraph 2(1)(c) of that Schedule.”3_ In section 47 (index), omit the entry for the “Statutory storage period”.4_ In Schedule 3 (consents), in paragraph 2(2)(a), for “statutory storage period” substitute “period for which, by virtue of section 14(3), the gametes, embryo or human admixed embryo may be stored under the licence”.Disposal of material
5_ In section 14 (conditions of storage licences), in subsection (1), after paragraph (c) insert—“(ca) that any gametes, embryos or human admixed embryos that have been kept in storage pursuant to the licence must, once they may no longer lawfully be so kept, be removed from storage and disposed of, and”.6_ In section 17 (the person responsible), in subsection (1)(c), for “allowed to perish” substitute “removed from storage”.Consent to storage
7_(1) Schedule 3 (consents) is amended as follows.(2) In paragraph 1—(a) in sub-paragraph (1), before the first “and” insert “any renewal of consent,”;(b) in sub-paragraph (2), before the first “and” insert “any renewal of consent by a person unable to sign,”;(c) in sub-paragraph (3)—(i) the words from ““effective consent” to the end become paragraph (a);(ii) after that paragraph insert—“(b) references to renewal of consent are to renewal of consent to the storage of any gametes or embryo under paragraph 11A or 11C.”(3) In paragraph 3, in sub-paragraph (1), after “gives” insert “or renews”. (4) After paragraph 11 insert—“Renewal of consent to storage of gametes11A_(1) This paragraph applies where—(a) the gametes of a person (“P”) are in storage,(b) P’s consent to the storage of the gametes is required under paragraph 8(1),(c) there is effective consent from P to the storage of the gametes, and(d) the gametes are being kept for use for the purposes of providing treatment services to—(i) P, or(ii) P and another person together.(2) The person keeping the gametes in storage (“K”) must, in each consent period, request P to renew consent to storage of the gametes within the renewal period.For the meaning of “consent period” and “renewal period”, see paragraph 11B.(3) A request under sub-paragraph (2) must be given in writing before the start of the renewal period.(4) The duty in sub-paragraph (2) ceases to apply if K is notified that P has died.(5) The duty in sub-paragraph (2) does not apply in relation to any consent period if—(a) K has at any time been informed in writing that P has been certified as lacking capacity to renew consent to storage of the gametes, and(b) K has not subsequently been informed in writing, before the start of the renewal period which relates to that consent period, that P has been certified as having capacity to renew consent to storage of the gametes.(6) P renews consent by informing K in writing that P consents to the storage of the gametes.(7) If P’s consent is not renewed under sub-paragraph (6) before the end of the consent period, K must, as soon as possible after the end of that period, give a notice to P stating that if P does not renew consent before the end of the renewal period, the gametes will be removed from storage and disposed of.(8) P’s consent to the storage of the gametes is to be taken as having been withdrawn at the end of a renewal period that relates to a consent period if—(a) K has complied with the requirements of sub-paragraphs (2) and (7) in relation to that consent period, and(b) P’s consent is not renewed under sub-paragraph (6) before the end of the renewal period.But this is subject to sub-paragraphs (9) and (10).(9) If, in a case referred to in sub-paragraph (8)(a) and (b), P dies before the end of the renewal period—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P died there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.(10) If, in a case referred to in sub-paragraph (8)(a) and (b), before the end of the renewal period P is certified as lacking capacity to renew consent—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P was so certified there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time. (11) But P’s consent is not to be taken as withdrawn under sub-paragraph (10)(b) if, before the time it would be taken to be withdrawn under that sub-paragraph—(a) P is certified as having capacity to renew consent to storage of the gametes, and(b) P renews consent to storage of the gametes by informing K in writing that P consents to their storage.(12) In a case where P renews consent under sub-paragraph (11)(b), this paragraph applies subsequently as if references to a consent period were to—(a) the period of 10 years beginning with the day on which P so renewed consent, and(b) each successive period of 10 years.11B_(1) For the purposes of paragraph 11A, each of the following is a “consent period”—(a) the period of 10 years beginning with the relevant day, and(b) each successive period of 10 years.(2) In sub-paragraph (1)(a) “relevant day” means—(a) the day on which the gametes are first placed in storage, or(b) in a case where sub-paragraph (3) or (5) applies, the day on which P gives consent to the storage of the gametes.(3) This sub-paragraph applies where the gametes are taken from or provided by P before P attains the age of 18 years and, at the time the gametes are first stored—(a) P has not attained the age of 16 years and is not competent to deal with the issue of consent to storage of the gametes, or(b) P has attained that age but, although not lacking capacity to consent to the storage of the gametes, is not competent to deal with the issue of consent to their storage.(4) In relation to Scotland, sub-paragraph (3) is to be read as if, for paragraphs (a) and (b), there were substituted “P does not have capacity (within the meaning of section 2(4) of the Age of Legal Capacity (Scotland) Act 1991) to consent to storage of the gametes”.(5) This sub-paragraph applies where the gametes are taken from or provided by P after P attains the age of 16 years and, at the time the gametes are first stored, P lacks capacity to consent to their storage.(6) In paragraph 11A “the renewal period”, in relation to a consent period, means the period which—(a) begins 12 months before the end of the consent period, and(b) ends 6 months after the end of the consent period.(7) In paragraph 11A “certified” means certified in writing by a registered medical practitioner.(8) In paragraph 11A and this paragraph, in relation to Scotland, references to a person lacking or having capacity to consent or renew consent are to be read as references to the person being or not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of consenting or renewing consent.Renewal of consent to storage of embryos11C_(1) This paragraph applies where—(a) an embryo, the creation of which was brought about in vitro, is in storage,(b) the embryo is being kept for use for the purposes of providing treatment services to— (i) a person (“P”) whose gametes or human cells were used to bring about the creation of the embryo, or(ii) P and another person together,(c) P’s consent to the storage of the embryo is required under paragraph 8(2), and(d) there is effective consent from P to the storage of the embryo.(2) The person keeping the embryo in storage (“K”) must, in each consent period, request P to renew consent to storage of the embryo within the renewal period.For the meaning of “consent period” and “renewal period”, see paragraph 11D.(3) A request under sub-paragraph (2) must be given in writing before the start of the renewal period.(4) The duty in sub-paragraph (2) ceases to apply if—(a) K is notified that P has died, or(b) K is notified under paragraph 4A(1)(c) of the withdrawal of a person’s consent to storage of the embryo.(5) The duty in sub-paragraph (2) does not apply in relation to any consent period if—(a) K has at any time been informed in writing that P has been certified as lacking capacity to renew consent to storage of the embryo, and(b) K has not subsequently been informed in writing, before the start of the renewal period which relates to that consent period, that P has been certified as having capacity to renew consent to storage of the embryo.(6) P renews consent by informing K in writing that P consents to the storage of the embryo.(7) If P’s consent is not renewed under sub-paragraph (6) before the end of the consent period, K must, as soon as possible after the end of that period, give a notice to P stating that if P does not renew consent before the end of the renewal period, the embryo will be removed from storage and disposed of.(8) P’s consent to the storage of the embryo is to be taken as having been withdrawn at the end of a renewal period that relates to a consent period if—(a) K has complied with the requirements of sub-paragraphs (2) and (7) in relation to that consent period, and(b) P’s consent is not renewed under sub-paragraph (6) before the end of the renewal period.But this is subject to sub-paragraphs (9) and (10).(9) If, in a case referred to in sub-paragraph (8)(a) and (b), P dies before the end of the renewal period—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P died there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.(10) If, in a case referred to in sub-paragraph (8)(a) and (b), before the end of the renewal period P is certified as lacking capacity to renew consent—(a) P’s consent is not to be taken as withdrawn under sub-paragraph (8), but(b) if at the end of the period of 10 years beginning with the day on which P was so certified there is still effective consent from P to the storage, P’s consent is to be taken as withdrawn at that time.(11) But P’s consent is not to be taken as withdrawn under sub-paragraph (10)(b) if, before the time it would be taken to be withdrawn under that sub-paragraph— (a) P is certified as having capacity to renew consent to storage of the embryo, and(b) P renews consent to storage of the embryo by informing K in writing that P consents to its storage.(12) In a case where P has renewed consent under sub-paragraph (11)(b), this paragraph applies subsequently as if references to the consent period were to—(a) the period of 10 years beginning with the day on which P so renewed consent, and(b) each successive period of 10 years.(13) Where P’s consent is taken as withdrawn under this paragraph, K must, as soon as possible, take all reasonable steps to give notice of the withdrawal to each person whose gametes or human cells were used to bring about its creation.(14) Storage of the embryo remains lawful until—(a) the end of the period of 6 months beginning with the day on which P’s consent is taken as withdrawn under this paragraph, or(b) if, before the end of that period, K receives a notice from each person notified under sub-paragraph (13) stating that the person consents to the disposal of the embryo, the time at which the last of those notices was received.11D_(1) For the purposes of paragraph 11C , each of the following is a “consent period”—(a) the period of 10 years beginning with the day on which the embryo is first placed in storage, and(b) each successive period of 10 years.(2) In paragraph 11C “the renewal period”, in relation to a consent period, means the period which—(a) begins 12 months before the end of the consent period, and(b) ends 6 months after the end of the consent period.(3) In paragraph 11C “certified” means certified in writing by a registered medical practitioner.(4) In paragraph 11C , in relation to Scotland, references to a person lacking or having capacity to renew consent are to be read as references to the person being or not being incapable (within the meaning of section 1(6) of the Adults with Incapacity (Scotland) Act 2000) of renewing consent.”PART 2TRANSITIONAL PROVISIONInterpretation
8_(1) In this Part of this Schedule—“the commencement day” means 1 July 2022;“the transitional period” means the period beginning with the commencement day and ending with 30 June 2024.(2) In this Part of this Schedule—“the 1990 Act” means the Human Fertilisation and Embryology Act 1990;“the 2009 Regulations” means the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) Regulations 2009 (S.I. 2009/1582);“the 2020 Regulations” means the Human Fertilisation and Embryology (Statutory Storage Period for Embryos and Gametes) (Coronavirus) Regulations 2020 (S.I. 2020/566).(3) In this Part of this Schedule—“gamete storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of gametes; “embryo storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of embryos;“storage licence” means a licence under Schedule 2 to the 1990 Act that authorises the storage of gametes, embryos or human admixed embryos;“pre-commencement”, in relation to a storage licence, or a storage licence of any description, means granted before the commencement day and “post-commencement” means granted on or after that day.(4) In this Part of this Schedule—“statutory storage period” has the same meaning as in the 1990 Act immediately before the commencement day;references to gametes, embryos and human admixed embryos have the same meaning as in that Act;“the training purpose”, “the research purpose” and “treatment purposes” have the same meanings as in section 14(3)(c) of that Act.Application of Part 1 to material already in storage
9_(1) The amendments in paragraphs 2 to 6 of this Schedule have effect in relation to pre-commencement storage licences under which gametes, embryos or human admixed embryos are kept in storage on or after the commencement day (as well as having effect in relation to post-commencement storage licences).This is subject to sub-paragraphs (2) and (3).(2) In the case of a pre-commencement embryo storage licence, the condition imposed by section 14(3)(c) of the 1990 Act (as substituted by paragraph 2 of this Schedule) does not apply in relation to an embryo which, on the commencement day, is kept in storage for the training or research purpose but not for treatment purposes.(3) In the case of any pre-commencement storage licence, the condition imposed by section 14(1)(ca) of the 1990 Act (as substituted by paragraph 5 of this Schedule) applies only in relation to times on or after the commencement day.10_ The amendments made by paragraph 7 of this Schedule have effect in relation to the storage of gametes and embryos under a pre-commencement gamete or embryo storage licence, where the gametes or embryos are kept in storage on or after the commencement day (as well as having effect in relation to the storage of gametes and embryos under a post-commencement gamete or embryo storage licence).Date of first storage
11_(1) This paragraph applies if the person storing gametes or an embyro under a pre-commencement gamete or embryo storage licence—(a) has, before the end of the transitional period, taken all reasonable steps to establish the date on which the gametes were or embryo was first placed in storage, but(b) is unable to establish that date.(2) The person may give a notice to each person whose consent to the storage is required under Schedule 3 to the 1990 Act specifying a date on which the gametes are or embryo is to be regarded as having been first placed in storage.(3) Where notice is given under sub-paragraph (2), the gametes are or embryo is to be regarded, for all purposes of the 1990 Act and this Part of this Schedule, as having been first placed in storage on the date specified in the notice.Storage periods specified in pre-commencement storage licences
12_(1) For the purposes of section 14(3)(a) of the 1990 Act (as substituted by paragraph 2 of this Schedule), a pre-commencement gamete storage licence under which, on and after the commencement day, gametes are kept in storage is to be regarded as specifying the period of 55 years beginning with the day on which the gametes were first placed in storage.(2) For the purposes of section 14(3)(b) of the 1990 Act (as substituted by paragraph 2 of this Schedule), a pre- commencement embryo storage licence under which, on and after the commencement day, an embryo is kept in storage for treatment purposes is to be regarded as specifying for those purposes the period of 55 years beginning with the day on which the embryo was first so kept.Storage after expiry of pre-commencement consent
13_(1) If a pre-commencement consent to the storage of gametes or an embryo expires at any time in the transitional period, the storage of the gametes or embryo for the remainder of that period is not unlawful merely because of that fact.(2) In sub-paragraph (1)—(a) “pre-commencement consent” means consent given under Schedule 3 to the 1990 Act before the commencement day;(b) the reference to expiry of consent does not include withdrawal.Storage with no effective consent prior to commencement
14_(1) This paragraph applies in relation to the storage of gametes or an embryo under a pre-commencement gamete or embryo storage licence where, immediately before the commencement day, there is no effective consent to the storage by a relevant person.(2) The person keeping the gametes or embryo in storage must request the relevant person to give consent to the storage under Schedule 3 to the 1990 Act.(3) A request under sub-paragraph (2) must be given before 1 July 2023 in writing.(4) The storage of the gametes or embryo at any time before the end of the transitional period is not unlawful merely because there is no effective consent to the storage by the relevant person.(5) In this paragraph—“effective consent” means consent under Schedule 3 to the 1990 Act which has not been withdrawn;“relevant person” means a person whose consent is required under Schedule 3 to the 1990 Act to storage of the gametes or embryo.Time for first renewal of consent
15_(1) This paragraph applies in relation to the storage of gametes under a pre- commencement gamete storage licence where the statutory storage period applicable immediately before the commencement day was provided for by—(a) regulation 4, 4A, 7 or 8 of the 2009 Regulations, or(b) regulation 4 of the 2020 Regulations.(2) For the purposes of paragraph 11A of Schedule 3 to the 1990 Act (as inserted by paragraph 7 of this Schedule), paragraph 11B(1)(a) of that Schedule has effect as if the reference to the period of 10 years beginning with the relevant day were a reference to the period which—(a) begins with the relevant day, and(b) ends at the end of the statutory storage period referred to in sub-paragraph (1).16_(1) This paragraph applies in relation to the storage of an embryo under a pre-commencement embryo storage licence where the statutory storage period applicable immediately before the commencement day was provided for by—(a) regulation 3, 3A, 5 or 6 of the 2009 Regulations, or(b) regulation 3 of the 2020 Regulations.(2) For the purposes of paragraph 11C of Schedule 3 to the 1990 Act (as inserted by paragraph 7 of this Schedule), paragraph 11D(1)(a) of that Schedule has effect as if the reference to the period of 10 years beginning with the day on which the embryo was first placed in storage were a reference to the period which—(a) begins with the day on which the embryo was first so placed, and(b) ends at the end of the statutory storage period referred to in sub-paragraph (1).Renewals falling due in the transitional period
17_(1) This paragraph applies in relation to the storage of gametes under a pre-commencement gamete storage licence in a case where—(a) paragraph 11A of Schedule 3 to the 1990 Act applies in relation to the storage, and(b) for the purposes of that paragraph, the first consent period (see paragraph 11B(1)(a) of that Schedule) ends in the transitional period.(2) Where this paragraph applies, paragraph 11A of Schedule 3 to the 1990 Act has effect in relation to that first consent period as if—(a) for sub-paragraphs (2) and (3) there were substituted—“(2) The person keeping the gametes in storage (“K”) must request P to renew consent to storage of the gametes before 1 July 2024.(3) A request under sub-paragraph (2) must—(a) be given in writing before 1 July 2023;(b) state that if P does not renew consent before 1 July 2024, the gametes will be removed from storage and disposed of.”;(b) in sub-paragraph (5)(b), for “the start of the renewal period which relates to that consent period” there were substituted “1 July 2023”;(c) sub-paragraph (7) were omitted;(d) for sub-paragraph (8) there were substituted—“(8) P’s consent to the storage of the gametes is to be taken as having been withdrawn at the beginning of 1 July 2024 if—(a) K has complied with sub-paragraph (2), and(b) P’s consent is not renewed under sub-paragraph (6) before 1 July 2024.But this is subject to sub-paragraphs (9) and (10).”;(e) in sub-paragraphs (9) and (10), references to the end of the renewal period were to 1 July 2024.18_(1) This paragraph applies in relation to the storage of an embryo under a pre-commencement embryo storage licence in a case where—(a) paragraph 11C of Schedule 3 to the 1990 Act applies in relation to the storage, and(b) for the purposes of that paragraph, the first consent period (see paragraph 11D(1)(a) of that Schedule) ends in the transitional period.(2) Where this paragraph applies, paragraph 11C of Schedule 3 to the 1990 Act has effect in relation to that first consent period as if—(a) for sub-paragraphs (2) and (3) there were substituted—“(2) The person keeping the embryo in storage (“K”) must request P to renew consent to storage of the embryo before 1 July 2024.(3) A request under sub-paragraph (2) must—(a) be given in writing before 1 July 2023;(b) state that if P does not renew consent before 1 July 2024, the embryo will be removed from storage and disposed of.”;(b) in sub-paragraph (5)(b), for “the start of the renewal period which relates to that consent period” there were substituted “1 July 2023”; (c) sub-paragraph (7) were omitted;(d) for sub-paragraph (8) there were substituted—“(8) P’s consent to the storage of the embryo is to be taken as having been withdrawn at the beginning of 1 July 2024 if—(a) K has complied with sub-paragraph (2), and(b) P’s consent is not renewed under sub-paragraph (6) before 1 July 2024.But this is subject to sub-paragraphs (9) and (10).”;(e) in sub-paragraphs (9) and (10), references to the end of the renewal period were to 1 July 2024.”Member’s explanatory statement
Part 1 of this new Schedule makes provision for the maximum period for which gametes and embryos may be stored, for what happens at the end of that period, and for a requirement that consents to storage be renewed periodically. Part 2 contains transitional provision.

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Moved by

[Lord Kamall]

313B: Clause 150, page 128, line 13, at end insert—
“(1A) A power to make regulations under section (Information about payments etc to persons in the health care sector), 89 or 90 includes power to make different provision for England, Wales, Scotland or Northern Ireland.”Member’s explanatory statement
This amendment provides for regulations under Part 3 of the Bill, and regulations relating to the reporting and publication of information about payments and other benefits provided to persons in the health care sector, to be able to make different provision for different parts of the UK.

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Moved by

[Lord Kamall]

314ZB: Clause 152, page 128, line 37, at end insert—
“(aa) in Part 2, sections (Information about payments etc to persons in the health care sector), (Regulations under section (Information about payments etc to persons in the health care sector): enforcement) and (Regulations under section (Information about payments etc to persons in the health care sector): consent) (information about payments etc to persons in the health care sector);”Member’s explanatory statement
This amendment provides for the powers relating to the reporting and publication of information about payments and other benefits provided to persons in the health care sector to extend to the whole of the United Kingdom.

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Moved by

[Lord Kamall]

315A: Clause 153, page 129, line 8, at end insert—
“(2A) Section (Storage of gametes and embryos) and Schedule (Storage of gametes and embryos) (storage of gametes and embryos) come into force on 1 July 2022.”Member’s explanatory statement
This amendment provides for the new Clause and Schedule relating to the storage of gametes and embryos to come into force on 1 July 2022.