Health and Care Bill

Baroness Penn Excerpts

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

Since my father’s time, much has changed in general practice. There are no night visits, no weekends, no accidents and no births. The preference is for living away from the practice area. A GP is available 40 hours a week, with the majority opting for part-time work. For the other 128 hours? Well, ring a number or go to A&E for excellent medical care. When the Royal College of GPs says that the prime duty of a doctor is triage, why bother to go to the GP when you are ill? Cut the triage. Go direct to the hospital where diagnosis and a prescription will be made. Once that has happened, follow-up care can be done by a nurse prescribing a regime. But we do not want that. We want to learn from the best of general practice, general practice prepared to give a full service with total commitment to its patients and a valued relationship. The good news is that there are many like that across the country. There are remarkable GP practices in tune with the communities they serve—inner-city, suburban, coastal, deeply rural areas that are isolated but resilient, isolated but vulnerable—

[Baroness Penn (Con)]

My Lords—

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As was mentioned, a key part of the Secretary of State’s recent big idea on future reorganisation was a plan to end GPs’ private practitioner status and bring all GPs under NHS control, even as we speak on this Bill and as we read recently in the media. How would the integrated care systems we are focusing on in this Bill fit into this further NHS reorganisation?

[Baroness Penn (Con)]

My Lords, this has been a long debate but it has touched on a number of different and important subjects. I join noble Lords in paying tribute to the work of the noble Baroness, Lady Greengross, and her work.

I turn first to Amendments 290 and 291. I reassure noble Lords that the Government are absolutely committed to the rollout of social prescribing across the NHS. We exceeded the targets in our manifesto and the NHS Long Term Plan of 1,000 new link workers by 2020-21 and are aiming for at least 900,000 people to be referred to social prescribing by 2023-24.

NHS England, the National Academy for Social Prescribing and Music for Dementia have produced guidance for social prescribing link workers to expand music prescriptions for those with dementia. The department has also published two resource guides for social workers on embedding music in personalised social care plans for people living with dementia and their carers.

While the Government are committed to promoting the benefits of social prescribing of music and arts for people living with dementia, it would be inappropriate to focus in the Bill on one form of therapy. Instead, we rightly provide scope in the Bill for the NHS to undertake a range of social prescribing.

Turning to Amendment 291 and the need for a dementia strategy, I reassure the noble Baroness and others that the Government are committed to publishing a new strategy this year. As part of this, we will be looking at arts and music-based interventions. More broadly, the strategy will focus on the specific health and care needs of people living with dementia and their carers, including looking at dementia diagnosis, risk reduction and prevention, and—importantly, as noble Lords have mentioned—research. Our priority is for the strategy to be credible and shaped by a range of experts, including people living with dementia and their carers. At the end of last year, we established a stakeholder-led task and finish group to help develop the strategy and deliver it in a timely way.

Moving on to Amendment 297D, we fully agree that visits from loved ones are of vital importance to care home residents’ health and well-being. DHSC guidance emphasises that visits to care homes should be facilitated, based on individualised risk assessments. Care home residents should also be supported to nominate an essential caregiver, who may visit in most circumstances, including if the care home has been closed to visiting for any reason.

There is an existing process in place if a resident or their family are concerned that guidance is not being followed. We encourage anyone with concerns to raise them. That can be done both with the care home, which has a legal obligation to operate a complaints procedure, and with the CQC. The CQC will follow up on concerns and take regulatory action if needed. It has provided mechanisms for people to feed back on concerns over care. The CQC responds to all concerns passed to it, and can receive concerns anonymously via representative groups, such as Rights for Residents. Where those concerns have named the provider or service in question, the CQC has followed up the cases. Some 54 concerns regarding care home visiting arrangements have been raised during the pandemic. The CQC gained reassurance in all cases that visiting is now in line with guidance. In 12 cases the CQC secured this assurance by inspecting the service.

My department has not seen any data or reports on evictions of residents following complaints against care homes. If a care home were taking such action, it would be in breach of guidance. A complaint should not lead to a resident being asked to move to a different home, and the terms of evictions and processes followed should comply with consumer law, as per the CMA guidance. People should feel confident that complaining will not cause problems for them.

I recognise this has been a difficult time for care home residents. However, the existing powers in legislation are robust and give protection to those who need it. We therefore do not feel at this time that an independent review is necessary.

I turn to Amendment 297A. Continuity and oversight of care is crucial in meeting the needs of all patients, including those aged over 65. That is why, since 2015, all practices have been required to assign their registered patients a named, accountable GP. This GP must lead in ensuring that any GP services that they are contracted to provide, and are necessary to meet the patient’s needs, are co-ordinated and delivered to that patient. Practices must take reasonable efforts to accommodate patients’ requests to be assigned a particular accountable GP and must endeavour to comply with all reasonable requests to see a particular practitioner. Practices are also required to take steps each year to identify any registered patient over 65 who is living with moderate to severe frailty. The practice must undertake a clinical review of any such patient and provide them with any other clinically appropriate interventions.

The noble Baroness, Lady Tyler, is right that delivering on this is linked to the number of GPs in the system. I assure her and others that the Government remain committed to growing the number of doctors. There were 1,841 more full-time equivalent doctors in general practice in September 2021 compared to September 2019. In 2021-22, a record-breaking number of doctors started training as GPs. I therefore consider that existing regulations already address the welcome intention of my noble friend Lady Hodgson, and I regret that the Government cannot accept the amendment for that reason.

I hope I have given noble Lords and noble Baronesses some reassurance on the amendments in this group and that the noble Baroness will feel able to withdraw the amendment.

[Baroness Greengross (CB)]

My Lords, I have listened to an extraordinary range of speeches and addresses. People have spoken from the bottom of their hearts. I am very moved myself by what I have heard. I thank all colleagues and Ministers who have spoken today. I will look very carefully at the record of today and come back, but, in the meantime, I beg leave to withdraw the amendment.

Elderly Social Care (Insurance) Bill [HL]

Baroness Penn Excerpts

2nd reading
Friday 16th July 2021 Lords Chamber

[Lord Flight (Con)]

My Lords, I, too, congratulate the noble Lord, Lord Lilley, on his Bill and on addressing territory that Governments should have addressed long before now. I agreed very much with my noble friend Lady Altmann’s speech.

The noble Lord, Lord Lilley, argued that social care provides two competing challenges to government. The first is the increased pressure on local social care budgets that comes with an ageing population, the increases in the national living wage and the risk of care homes closing. The second is resentment from homeowners and their relatives who risk having to sell their homes to pay for social care. He advises that both problems could cost billions to solve and that, where there is more placating of homeowners, less finance will be available to provide decent care for those in greatest need.

Under the Bill, a state-owned insurance company would be set up and guaranteed by the state. The cost of insurance would be calculated to be actuarially sufficient to pay for all the care. If they wished, people would be able to pay for the insurance via a charge on their homes, which would be realised when they died. That charge would typically be a modest fraction of the value of any home and nobody would be required to take out such insurance. Based on updated figures and the calculations from the Dilnot commission, the noble Lord, Lord Lilley, calculated that a theoretical premium would be approximately £16,000 and the average cost to social care, supported by local authorities, would be £25,000, as he said. I question whether the noble Lord’s insurance premium of £16,000 per annum will be sufficient.

The Bill does not address the point that there is a perceived unfairness, with those who have worked hard and saved having to pay their care costs while those who have spent all their incomes get their social care costs paid for. Those people should arguably get state-provided care, which would be of a more basic nature than the care that individuals purchase. The main objective of the noble Lord, Lord Lilley, is to weaken the political pressure from homeowners for the state to provide them with free social care, but his arrangements entail the state insurance body realising its charge on a property on the death of the insured person or the sale of that property—the charge being the fraction, set aside at the time of the purchase of the policy, of the value of the property at the time of death, net of mortgage.

The terms of the Bill do not therefore fully avoid the much-disliked arrangement of the public sector taking value from a deceased citizen’s property, even though it would be much less under the noble Lord’s system. The insurance arrangement would operate such that the insured persons would be entitled to social care from their local authority, which would be reimbursed for the cost of the care provided. The weakness here is that there is no incentive for the local authority to keep the care costs as low as possible.

The proposals of the noble Lord, Lord Lilley, are complicated and do not—

[Baroness Penn (Con)]

I must remind the noble Lord of the advisory Back-Bench time limit for this debate.

[Lord Flight (Con)]

They do not include the cost of care homes. In my view, what is needed is a less complicated and more standardised approach.

Women’s Health Outcomes

Baroness Penn Excerpts

Thursday 8th July 2021 Lords Chamber

[Baroness Greengross (CB) [V]]

My Lords, I welcome today’s debate on women’s health outcomes and thank the noble Baroness, Lady Jenkin of Kennington, for bringing this Motion to the House today in an extraordinarily moving way.

We know that there are many conditions where women are overrepresented—for example in mental health, where 26% of young women have experienced anxiety, depression or eating disorders. We know that with gynaecological conditions it often takes seven to eight years to receive a diagnosis of endometriosis, with 40% of women needing 10 or more GP appointments before being referred to a specialist.

In one area of women’s health, I became aware late last year that there was a national shortage of widely used contraceptive preparations and hormone replacement therapy products. In response to my Written Question, the Minister, the noble Lord, Lord Bethell, responded that this shortage was due to

“Issues such as regulatory or manufacturing problems, problems accessing supplies of pharmaceutical raw ingredients and commercial decisions to divest certain products”,


which

“can affect the supply of medicines.”

Throughout 2020, thousands of women were not able to access their normal oral contraceptive or hormone replacement therapy products. This is one recent example of women not having access to the pharmaceutical products they regularly used, though this also happens, as we know, with various medicines that both men and women take.

I declare my interest in the register as co-chair of the All-Party Parliamentary Group on Bladder and Bowel Continence Care. Women are five times more likely to develop urinary incontinence than men. This is something many women feel uncomfortable talking about or raising with their GP. For many women, bladder continence issues can result in a loss of independence, as they feel unable to leave their homes unless they know there are accessible public toilets near to where they are going. Much like gynaecological conditions, issues with continence care can take time to diagnose and cannot always be treated. Much greater awareness is needed of these conditions and, in particular, how they impact on women’s lives.

My final point is to draw attention to some depressing findings from the 2020 Marmot report, about which the noble Lord, Lord Rooker, spoke so movingly just now. According to Sir Michael’s 2020 report on health disparities, women living in the most deprived 10%—

[Baroness Penn (Con)]

My Lords, I am afraid I am going to have to remind the noble Baroness of the time limit for Back-Bench contributions, given the number of speakers we have in this very important debate.

[Baroness Greengross (CB) [V]]

Can I finish or not?

[Baroness Penn (Con)]

My Lords, I suggest to the noble Baroness that perhaps she is already over the time limit and that we move on to the next speaker.

[Baroness Greengross (CB) [V]]

Okay.

Coronavirus Act 2020 (Early Expiry) Regulations 2021

Baroness Penn Excerpts

Monday 5th July 2021 Grand Committee

[Baroness Brinton (LD) [V]]

My Lords, at the one-year review of the Act, we pushed for it not to be reviewed. It would have been really useful to understand why there has been such a delay. I remind the Minister that we were concerned over some of the civil liberties issues in the Act, such as on policing, protests and fines—we know the fines did not hold up when applied in practice—and over transparencies. We have raised repeated concerns about the transparency on the dashboard. We were also concerned about people not understanding the rules. Famously, where guidance versus the law happened, it was interesting to watch the Government having to retreat very fast when they realised that they were telling people in Greater Manchester that something was covered by the law, yet the people in Greater Manchester were clearly able to show that it was guidance.

There are also concerns about the enormous blank-cheque powers that this legislation has provided. I am grateful to the noble Lord, Lord Bethell, for saying earlier that the expiry of these provisions was announced on 25 March. His exact words then were:

“We made a promise to Parliament that we would not keep any provision in place for longer than was necessary, and we have made good on that promise.”—[Official Report, 25/3/21; col. 985.]


It has been 14 weeks since the Government decided that they did not need the provisions, and they have not yet removed them. They are still in place until this SI comes into force.

We also had particular concerns about the provision of social care. Part 1 of Schedule 12 and Section 15 enabled local authorities to divert resources to care and support from other duties. This was used eight times and not since 29 June 2020. We were really concerned about this provision because those who needed support for care suddenly found it was removed. The parents of disabled children who needed 24-hour care had found that their entire support mechanisms were removed from them. On the Disabled Children’s Partnership website today, one mother has been saying that the lack of that support has meant that she and her husband have had no more than two hours of consecutive sleep in over a year, because they have had to try to manage it. They are both utterly exhausted and extremely concerned that they might be making mistakes. That is because of the loss of this diversion support. What is particularly worrying is that most local authorities have not yet reinstated it.

Because we still do not know when this SI will come in, it is a little difficult to approve it until we also know the exact details about the level of Covid in our communities and its effect on the NHS. The Prime Minister famously talked about “data, not dates”, but the dialogue in recent weeks has become entirely the other way around, with cheery communications about the mask mandate being about to go. It is very noticeable that people have taken that as a signal that they can stop wearing masks already. Yet just over a year ago in June, when we lifted that first lockdown, cases were down to around 1,000 a day. This last week, it was around 25,000 new cases per day with hospitalizations increasing, even if at a lower rate, and certainly—thank goodness—ICU occupancy at a lower rate. However, GPs, doctors and nurses in hospitals all report that the NHS is nowhere near going back to being normal.

Today on LBC, a member of ICU staff at a hospital called in to say: “They can keep the medal and just get everyone to keep wearing masks, if they truly care about NHS staff”. I am with her on that one. Also today Chloe Smith, the Constitution Minister, said that some people more susceptible to infection than others may wish to carry on using a face mask. She cited her recent cancer, saying that she sympathises with those who want to carry on taking precautions.

As the Minister knows from my repeated raising of this issue, for some people this is not a matter of choice. That is so for at least 1 million people in the country: the clinically extremely vulnerable. Current government guidance to the CEV, which came out on 21 June, says:

“We are also advising clinically extremely vulnerable people to … follow the practical steps described below to minimise your risk of exposure … close contact with friends and family will be a personal choice, but you are encouraged to exercise caution”.


They were advised to work from home but, if they could not, to get their employer to make their workspace Covid-safe—I am paraphrasing because the guidance goes on at some length—and otherwise to get advice from professionals. It also says that the furlough scheme will end in September.

In addition, from 1 April there was no longer any SSP for clinically extremely vulnerable people who could not work from home. It is really important that provision is made to avoid clinically extremely vulnerable people having to go to work. Will the Government now take this up? Losing the mask mandate and lifting regulations mean that this group in our society and their immediate carers are put at risk.

I also note that the clinically extremely vulnerable advice says that pupils should be back in schools but the Department for Education lifted the mask mandate for schools some time ago. These children are still at high risk of Covid, which could indeed—

[Baroness Penn (Con)]

I remind the noble Baroness that the speaking limit for Back-Benchers is five minutes.

[Baroness Brinton (LD) [V]]

Thank you. I have finished.

Covid-19 Update

Baroness Penn Excerpts

Tuesday 29th June 2021 Lords Chamber

[Lord Hussain (LD)]

My Lords, the hotel quarantine for those returning from red-list countries is having a huge, stressful impact on those using the hotels. I have a couple of examples to share and one or two suggestions to make. The first case is family A from Huddersfield. They went to bury their father in Pakistan. On return, they had huge difficulty booking hotels. At Heathrow Airport some family members were taken to Swindon and others to Camberley, which are about 50 miles apart. They could not be put in the same hotel, for some reason. They have made a formal complaint. I have received a copy of it and I am willing to send it to the Minister as well. It shows the level of dissatisfaction people are feeling.

The second example is from my home town, Luton, where, sadly, a young teenager lost his life in a tragic incident. His father and some other relatives, including somebody who is epileptic, were in Pakistan at the time. On their return, whatever amount of stress they had, they were taken to the hotel straightaway and were not allowed out, other than just coming for the funeral.

The third example—and I would say a more tragic one—is a family who went to Pakistan before it was put on the red list. The father was under stress and there are two disabled children. The mother died there and the children are waiting to come back to the UK—

[Baroness Penn (Con)]

My Lords, the noble Lord may wish to direct his question to the Minister at this stage.

[Lord Hussain (LD)]

My Lords, the suggestion is, please can those returners be tested and those who are found to be positive asked to quarantine in their own home? To observe their quarantine, they should have some kind of electronic tag instead of being put in expensive hotels and having these terrible experiences.

Social Care and the Role of Carers

Baroness Penn Excerpts

Thursday 24th June 2021 Lords Chamber

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

My Lords, I wish to take a moment to reflect in honour of all those who lost their lives under this Government’s watch and their loved ones who mourn their absence. I want also to record my thanks to all front-line staff for their perseverance during what was a dangerous time.

I too welcome the work of the Care & Support Alliance and place on record my respect for the outstanding advocacy of Carers UK, Rethink and the Disabled Children’s Partnership. I salute the valiant leadership of my noble friend Lady Pitkeathley. I humbly thank the noble Baroness, Lady Jolly, for enabling this conversation.

Speaking as a parent, I can say that caring for someone you love is a lifelong, all-encompassing devotion. According to Carers UK, during the pandemic more than 13 million people provided unpaid care—72% without any break or support. There was a 78% increase in demand for their care, with no response. An estimated 1.2 million carers live beyond poverty. The Government cannot say that they do not know these facts. Even with the time constraint, the detrimental underfunding of social care cannot be overemphasised. It has resulted in an enormous toll on individuals not having their most basic and urgent care needs met, as well as on those who do everything they can for their loved ones.

The system is failing more than 1.5 million of those who need urgent care as a result of government policies and constraint on local authorities. Services are crippled, including voluntary organisations that have been and are a lifeline for the most disadvantaged in our communities.

I wish briefly to speak about the dire situation of hundreds of thousands of families caring for their loved ones with disabilities and autism, which was recently highlighted by the Disabled Children’s Partnership report No End In Sight. I commend it to your Lordships. I have heard first-hand testimonies from several of the parents panel families, who have felt broken, ignored and abandoned over recent years—more so over the past months because they have not received their most basic care services and cannot access what they regard as crucial physical and language therapies and mental health support, with significant adverse consequences for their families’ well-being.

In my social work career, I have had the privilege of managing care homes. I appreciate their invaluable resilience, which was so evident during the early months of the pandemic. I also am fully aware of, have witnessed and have managed at first hand the fallout of the ugliness of abuse of the elderly and the disabled, much of which remains unreported—markedly so in unregulated care homes. Will the Minister assure the House, in the light of the recent case against the National Autistic Society, on what additional safeguards and monitoring are in place to prevent such abuse occurring yet again?

The time for integrated care, free at the point of delivery, is now. As the noble Lord, Lord Forsyth, and other noble Lords have eloquently said, we need political will and leadership, as well as a willingness to work alongside local authorities and leading organisations to cherish the fundamental principles of choice, control and—

[Baroness Penn (Con)]

My Lords, I am afraid I am going to have to remind the noble Baroness of the time limit for the debate.

[Baroness Uddin [V]]

Thank you. We want the dignity of independence for those who are living with disability and their carers.

Covid-19: One Year Report

Baroness Penn Excerpts

Thursday 25th March 2021 Lords Chamber

[Lord Tyler (LD) [V]]

My Lords, the legislation we are reviewing today was passed in a genuine emergency. The concern on 19 March 2020 was not whether it was too rushed, but whether it had been delayed too long. That is obviously no longer the case. Today we have all had 12 months’ experience of its operation, and even with the two-monthly reports and the current reassessment it is by no means evident that Ministers have taken full advantage of the lessons that have been learned.

It is the constitutional duty of your Lordships’ House to check, in the light of that experience, whether the Act includes what should be there, excludes what should not be there and manages appropriately what it does include. In the first category, it is abundantly clear, as has just been said, that the regulations for awarding contracts for Covid-related purposes have been woefully inadequate and that their lack of transparency has been outrageous. Each week, there seems to be yet another excuse from the Government to the courts that publication of a contract was delayed because civil servants were distracted by other Covid commitments, but once a contract was signed and sealed what were they, or indeed Ministers, doing with that contract which required even a day’s delay?

In the category of matters that were included, but clearly need not have been, the current long list of changes is ample testimony to necessary exclusions. However, we also would have expected Ministers to have corrected much earlier the confusion that the police and public encountered with charges for infringing regulations. The fact that, as at the end of February, every single prosecution under Sections 21 and 22 of the Act seems to have been found to be unlawful displays a woeful failure. That the CPS should have had to overturn 252 unlawful charges since March 2020 is a stain on our judicial system. It is important to reiterate the fact that necessary restrictions on movement, businesses and gatherings do not depend on this legislation. The Public Health (Control of Disease) Act 1984 would continue to exercise that control even if the House decided to take more time examining the validity of the very complicated and extensive provisions of this Act.

In the third category, the way in which the Act deals with what is legitimately included, we again have to remind Ministers that they no longer have the excuse of urgency and an unprecedented emergency. The report of our excellent Delegated Powers and Regulatory Reform Committee, published just four days after the Bill was introduced in the Commons, is salutary reading. Ministers will recall that its primary recommendation was as follows:

“Whilst in no way resiling from the appropriateness of this exceptional approach, we nonetheless believe that it is important for us to state clearly that, had the country not been in the midst of a developing national emergency, there are powers in this Bill, including far-reaching Henry VIII powers, about which our commentary would have been far more trenchant and our recommendations far more robust. Given this, we have recommended that the expiry date for the Bill should be set at one year without a power to extend—not two years, with the possibility of extension—thereby enabling the Government to exercise the powers needed in the immediate future while allowing a further bill to be introduced and subject to parliamentary scrutiny in slower time.”


Tragically, Ministers resisted that powerful advice.

The committee noted a host of Henry VIII powers for a number of very significant ministerial actions. In a number of cases, it drew the attention of this House to powers which were in no sense relating only to the coronavirus outbreak. It called for an “ironclad assurance” that they would not be used elsewhere. On what was then Clause 74, the Committee warned:

“A decision to suspend or revive emergency measures might well be politically contentious. We would expect such regulations to be subject to a parliamentary procedure.”


Even when there was a process included, as with the many Henry VIII powers, the Government proposed only the very limited negative procedure.

Nearly two weeks after Royal Assent, the Minister eventually responded to the DPRRC. He blandly dismissed recommendation after recommendation on the grounds of the

“serious and imminent threat to public health.”

He argued that the Committee’s concern over Clause 74, which became Section 88, was met:

“The regular reports to and debates in Parliament provide ample transparency, oversight and potential for challenge to the use of these powers.”


Sadly, the failure of the government business managers to enable the two-monthly reports to be scrutinised effectively has made that promise worthless.

This House took into account the exceptional urgency when it gave its consent to the Bill in March 2020. It did so with the grave constitutional misgivings of the DPRRC duly noted. Unless Ministers are now claiming that they have learned nothing from the past year and that they are as unclear on how to meet the current challenge of the pandemic as they were then, there is no justification for the House to sign another blank cheque. We should insist that the rushed, rough and ready legislation of March 2020 will no longer suffice.

Finally, today I grievously miss the usual Greaves forensic analysis—

[Baroness Penn (Con)]

My Lords, I must remind the noble Lord that there is a time limit for Back-Bench contributions of five minutes.

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[Baroness Penn (Con)]

My Lords, the advisory time limit for Back-Benchers is five minutes in this debate.

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[Baroness Mallalieu (Lab) [V]]

My Lords, on 13 March last year, this country had a carefully prepared plan from the Department of Health, which the noble Baroness, Lady Walmsley, referred to. It was to be used in the event of a pandemic caused by a serious respiratory disease with a projected death toll of up to 750,000. It involved shielding the elderly, the sick and the vulnerable, but keeping life as near normal for the healthy and the working population. China had imposed a draconian lockdown; Italy, France and Spain followed and got away with doing it. Overnight, our plan was dropped into the wastepaper basket and we followed the others. Was that wrong? With hindsight, I believe that it was. Would I have made the same decision on lockdown then? Possibly, but knowing what we do now I would not.

Those who advised that decision, those who made it and those who subsequently supported it were doing their best as they saw it to protect the population from a highly infectious, deeply unpleasant and sometimes fatal disease. How did they persuade us to comply? How did we so readily and swiftly surrender our freedom? First, we were told that, if we did, we would beat the virus and, in the Prime Minister’s words, put it “back in its box”. Then, this nation’s affection for our National Health Service was employed mercilessly. The fact is that successive Governments have underfunded and mismanaged the NHS, so we have the lowest critical care capacity in Europe.

Fear and guilt were part of the Government’s strategy: Don’t kill your granny”, and the advertisement with the old man pictured in a mask, asking “Can you look him in the eye?” There were swingeing fines for trivial breaches and even a government Minister urging people to report their neighbours for any rule infringements, which was presented as some sort of praiseworthy, patriotic act. All this was set against a background of relentless media coverage of hospital crises and deaths. Of course we all wanted to help to beat this virus, but a great many people were also very frightened, many unnecessarily, and many still are.

The full consequences of that decision are now much clearer. I hope that it reduced the death toll, but ours is still one of the largest in the world. However, as a result of that decision, a health crisis has been supplemented by both an economic and a social one. Massive damage has been done to the education of our children and to our businesses, industry, court system, arts and culture. There is a massive backlog of people who are in urgent need of treatment for serious, often fatal, conditions, some of whom have died or will die for lack of it. Basic human needs and civilised rights were prohibited: the need to be with a dying relative, to hold a mother’s hand in a care home, to hug grandchildren. The toll on mental health is incalculable.

We were told then, and at each successive lockdown, that this would be temporary, until a vaccine came along. I am afraid that that has proved unrealistic. Now we are being told that the virus is endemic and we will have to learn to live with it. The vaccine has been brilliantly created in record time and is being superbly administered through the NHS. It may protect the vaccinated against the worst aspects. More and better treatments will also, hopefully, be found, but this virus is going to continue indefinitely.

Against that background, we must surely resolve never again to use lockdown in this way in a health emergency such as this. The noble Lord, Lord Foulkes, was right. Parliament, too, must not allow itself to be sidelined again. We have had legislation with virtually no debate; we have had ex post facto debate on legislation already in force. We have had guidelines that have been accorded the status of law, with constant changes and uncertainty, so that, as the noble Lord, Lord Lansley, said, the public, police and even parliamentarians find it impossible to keep track of the latest rules and timetables.

The police, too, have been put in an impossible position, not just in policing lawful, dignified, peaceful protests but in trying to enforce legislation, some of it so petty in its application as to be laughable. I cannot forget the image of the elderly couple with their sticks, sitting together alone on a park bench, resting briefly during their one hour of permitted exercise, being made to move on by police. It is still going on: last week, an 83 year-old woman in Cheltenham was visited by two policemen at night, having been reported for having a cup of tea with two friends in the garden of her sheltered home. She was told that she would be fined if she did it again. If you enact bad law, people lose respect for it. Look out on the streets on any fine day, or at the beaches when it is hot, and you can see it. People are making their own decisions about the level of risk that they are prepared to take for themselves, their families and their friends. If those who have never broken any rule since March were asked to put their hands up, I do not believe that there would be many in the air.

Here we are again today, doing it all again, taking a few regulations away, adding more and changing the ever-moving goalposts. These provisions go through because there are not enough people in Parliament—too few like the noble Baroness, Lady Noakes—who will stand up and say, “Enough is enough”.

[Baroness Penn (Con)]

My Lords, I remind the noble Baroness of the advisory time limit for Back-Benchers.

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[Lord Bethell (Con)]

I very much thank noble Lords for an incredibly broad and wide-ranging debate. It has been a really honourable birthday party for the Coronavirus Act, and I hope that the Act is grateful for the tributes it has had. I confess that I am proud of the Act, and proud of the collaborative spirit in which it was drafted and passed. I am proud of the measures it supported to make the lives of the people of Britain a lot better during this awful pandemic and I am enormously grateful for the wide-ranging support here in this House during the last year. There has been scrutiny and challenge, but I am grateful to noble Lords for the general tone of support offered to the Government, and to myself in particular.

In terms of the regulations, I think the noble Baroness put it very well: the regulations we are debating today are tough but they are necessary, and I cannot think of a better way of putting it than that. On the specific question asked by the noble Baroness, Lady Thornton, on gatherings, I would be glad to write to her with an answer. On the questions that many noble Lords had on the road map, I am not in a position to do a road map pub quiz from the Dispatch Box right now. The Prime Minister has laid out a really clear schedule and there are update sessions already built into that schedule. Noble Lords will need to wait, I fear, for updates from Downing Street on that.

Instead, I should like to pick out two or three of the major themes that noble Lords raised in this broad debate. One of the most powerful came at the beginning with the comments from the noble Lord, Lord Hunt, reinforced by many other noble Lords, on the issue of health and the question of levelling up. I recognise the deep concerns, which I share, about the spotlight that the pandemic has put on the health of the nation. Without doubt, one of the reasons why we have been hit hard by the pandemic is that large parts of our population are simply not in great shape at the moment. They have either poor health, poor living conditions or poor circumstances. The noble Lord’s comments were absolutely spot on.

My noble friend Lord Moynihan put an emphasis particularly on BMI, weight and fitness in the country. They are clearly not good enough and there is widespread acknowledgement of that. That is in no way to shame any individual or section of society. It is a simple fact of life that we do not compare well to other countries. The Prime Minister has spoken movingly about his personal experience and the issue is something that the nation has to have a conversation about. The obesity strategy is a framework for that, but it is not the only thing that we will be doing in this area.

Our reach-in as government—not just as national government but in local government, agencies of government and the NHS—to some parts of society is just not good enough. This is not a BAME issue, although that is part of it; I am talking about everywhere from the sweatshops of Leicester to the apple orchards of Herefordshire. There are too many communities where we simply do not get our message across or have a dialogue, and where our services are not provided in a way that people find accessible. We have to ask ourselves tough questions about how we can do better. That is because we are only as good as a nation as the health of the most vulnerable people in our society. That includes everyone from working-class white communities in South Wales all the way through to those in the mill towns of northern England. We have to work with faith groups, on our languages and on the services that we offer in a great many ways.

We have to join up our healthcare services. That is something for which the healthcare system has been calling for a long time, which was apparent during our engagement exercise two years ago. It is well built into the NHS Bill that will be coming our way very shortly. We have to join up primary, secondary and public health across the piece. Only in that way can we address the population health issues that have bedevilled the country in the past year.

Lastly, we have to embrace technology. We have done a huge amount of good work in the past year with data, med tech and a more 21st-century approach to healthcare. There is still a huge amount that we need to do. We need to encourage people to engage with their own patient records and data and help them to understand that they can take greater responsibility for personalised medicine if they engage with their patient records and systems. I am optimistic that we can make progress in that area.

My noble friend Lady Noakes and a great number of others remarked on the impact of the pandemic, not just on those who have been ill from Covid but on all the others who have not had either elective surgery or treatment, or missed out on diagnostics and testing—those secondary impacts on the healthcare system. That does not come as a surprise. It is neither a secret nor a conspiracy. It is exactly how epidemics hit healthcare systems. It happens time and again.

[Baroness Penn (Con)]

My Lords, I am sorry to interrupt the Minister’s speech but those participating remotely cannot hear it. Therefore, the House will adjourn while we try to resolve the technical issues.

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[Baroness Penn (Con)]

My Lords, I am afraid that the technical problem is not yet resolved. The House will therefore adjourn until a convenient moment after 6.45 pm.

Health and Social Care Update

Baroness Penn Excerpts

Monday 22nd March 2021 Lords Chamber

[Lord Bethell (Con)]

My Lords, I am grateful for the broad and large hook that the noble Baroness has provided me with. I reassure her that not only do we have a massive amount of support already in place for social care to help it through the current pandemic and the huge amount of pressure that has been put on its staff, residents and supply chain; we also have put in place an enormous amount of financial support for local authorities to ensure that they can provide the kind of improvements to social care that are needed. One area in which we have made enormous advances is care tech—that is, digital and technologically driven support. It has taken a huge step forward in the last year and impacted enormously on the lives of those in social care of all kinds.

[Baroness Penn (Con)]

My Lords, we are having technical difficulties. I beg to move that the House do now adjourn until 3 pm.

Health Protection (Coronavirus, Restrictions) (All Tiers) (England) (Amendment) Regulations 2021

Baroness Penn Excerpts

Monday 8th February 2021 Grand Committee

[Lord Winston (Lab) [V]]

First, perhaps I may apologise to the noble Lord, Lord Bethell. On Thursday 4 February, I asked about antiviral drugs: Synairgen’s compound SNG001, an inhaled interferon beta drug, and the controlled trial which had been published in the Lancet and which showed considerable success. I also mentioned ACTIV-2, research established by the National Institutes of Health in the US. With the limits on time to reply to the Statement, I muddled Synairgen’s seemingly effective trial with ACTIV-2, giving the impression that it was a different drug. This made it impossible for the noble Lord to answer my question effectively and I apologise for that.

As many noble Lords have repeatedly affirmed from across the House, we must work together, particularly at times of national emergency. While I speak from these Benches, it is good to celebrate the spirit of proper collaboration of which your Lordships’ House is proud. This is a time of global emergency. Of course, we want to be vaccinated as soon as possible. With vaccines still not plentiful, it is natural to be anxious about ourselves and our families, but we must recognise those elsewhere globally, and particularly in poor nations. It makes economic sense, just as it does with climate change. It may be costly, but it is morally right, and the global fight is essential, not least because of our self-interest.

We should learn from history. Yersinia pestis, the Black Death, caused at least three major pandemics: the plague of Justinian in 1541, the Black Death in 1347 and the Black Death in China in the 1850s. There were repeated, devastating waves in between for many decades. These were spread mostly by travel, by mixing of populations and by people in poverty with poor hygiene and inadequate public health. In 1665, when over 100,000 people in London—probably one-third or more of the population—died in the Great Plague, the greatest proportion were poor and disadvantaged. Lockdown then was rigidly imposed. People were even bolted in their houses, which were painted with a red cross.

The science community has repeatedly warned that we shall almost certainly need to live with Covid for a long time to come. This is likely for Covid-19 but is equally likely to be true of other deadly viruses in due course. So, in addition to global issues, we need everything we can muster: vaccines, better diagnostics, culture facilities, better public health—especially globally—and drugs which kill the virus. We also clearly need isolation, and that will reoccur from time to time. It is important that we do not breathe a huge sigh of collective relief at the blessing of new and better vaccines. There are still many important questions that we will need to consider. Randomised controlled trials must continue. One NIH trial, for example, done in the rhesus monkey, showed that they got protection with different vaccines, but these did not necessarily reduce the replication of the virus in nasal tissues, while some others did. Those are the sorts of reasons why we still do not know how problematic contact between people will be.

Whatever the effectiveness of different vaccines, apart from new mutations, there will be pockets of this virus in the population. If we are to reduce the presence of the virus in our communities, at what stage do we consider vaccinating children? If we eventually do, shall we ignore the serious anti-vaccination protests associated with measles, a far less clinically risky virus? We are relatively safe now from yersinia pestis, not because of vaccines but because of antibiotics. For example, a portable, easily distributed antiviral would be a real asset. Unfortunately, monoclonal antibodies, mentioned by the noble Lord, Lord Walney, in last Thursday’s debate, may not be quite as useful as a portable, easily distributed and administered antiviral, which could give safety, with fewer side-effects, at the early stages of infection. This might kill the virus before it starts to replicate rapidly. That would be useful during lockdown. An antiviral which gets access to the mucus membranes of the throat, pharynx, larynx and respiratory system, taken by mouth or as an aerosol, could be particularly beneficial because that is the route that the Covid virus generally takes. That would be another strategy to avoid the risk of mutations. This may be important, because we must remember how coronavirus is likely to have infected several animal species before moving into man. It is consequently more dangerous. In many parts of this crowded world, humans now perhaps live more closely to animals than at any time in our history.

Of course, we shall continue to jog the Government, but let us do so in the spirit of constructive collaboration that is important at this time of national emergency.

[Baroness Penn (Con)]

My Lords, I remind noble Lords that the time limit for Back-Bench contributions is four minutes.

Medicines and Medical Devices Bill

Baroness Penn Excerpts

Report stage & Report: 2nd sitting (Hansard) & Report: 2nd sitting (Hansard): House of Lords
Thursday 14th January 2021 Lords Chamber

[Baroness Penn (Con)]

My Lords, we appear to have lost the connection to the noble Baroness, Lady Thornton, so I suggest that we adjourn for five minutes.

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[Baroness Thornton (Lab) [V]]

I thought these amendments were part of the group that was passed on Tuesday?

[Baroness Penn (Con)]

The noble Baroness is correct that Amendment 27 is consequential to an amendment agreed on day 1 of Report, so she may wish to move it.

[Baroness Thornton (Lab) [V]]

I think Amendment 26 is similar, possibly. We may need some guidance from the clerk. Was Amendment 26 also related to the group of amendments that were agreed on Tuesday? I apologise; it is always difficult to do these things when you are not actually in the Chamber.

[Baroness Penn (Con)]

My understanding is that Amendment 26 is also consequential to amendments passed on day 1 of Report, so we may wish to ask the noble Lord, Lord Patel, whether he wishes to move his amendment, which is consequential to previous amendments agreed.

[Baroness Thornton (Lab) [V]]

That is what I thought

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[Baroness Penn (Con)]

The noble Lord may wish to know that the amendment is consequential on an amendment passed earlier on Report, so he or a fellow signatory may wish to move it.

Amendment 63

Moved by

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[Baroness Thornton (Lab) [V]]

The noble Baroness, Lady Jolly, is quite right: two of our health big thinkers have laid out the issues here. My noble friend Lord Hunt gave a wonderful introduction to Amendment 66, which covered the reasons why it is important and what it will do. The noble Lord, Lord Lansley, took us on a journey through how health inequalities can be addressed. The point, and the reason the amendment is on the Marshalled List today, is that it does not always work like that. Implementation is key. As the noble Baroness, Lady Jolly, said, requiring NICE to support NHS access to new medicines and medical devices seems kind of obvious. The challenge for the Minister here is how to use this legislation and this discussion to make what we think is obvious work better.

[Baroness Penn (Con)]

My Lords, I know the noble Lord, Lord Hunt of Kings Heath has a long-term interest in and commitment to the work of NICE and, as such, will know that NICE’s remit is set out in other legislation. I do not intend to rehearse the arguments on why we do not see that as strictly for this Bill. Instead, I hope to provide some reassurance on the issues he raises with his amendment.

The noble Lord will be aware that NICE’s methods and processes for assessing the cost-effectiveness of medical technologies are internationally respected and have been developed over almost 20 years through periodic review, including extensive engagement with stakeholders, and the latest iteration of that process of periodic review of its methods is ongoing. NICE finished the first phase of its consultation on the case for change to its methods on 18 December 2020. There will be a second consultation on the case for change to its processes in the spring. The result of those will inform the final consultation on the updated methods manual in summer 2021. I hope that the noble Lord is reassured by the consultative nature of that process in considering the issues he raised.

Subsection (1)(a) of the new clause proposed in his amendment would require NICE to address the implications of health inequalities when assessing the cost effectiveness of medicines and medical devices. Subsection (1)(b) would require NICE to accept a greater degree of uncertainty and risk in recommending their use. I reassure the noble Lord that NICE is already considering both of those as part of its review, and they were both consulted on as part of the consultation on the case for change that ran from 6 November to 18 December 2020.

In that consultation, NICE noted that there may be a case for a modifier that considers health inequalities. However, further work is needed to explore how this could be defined and implemented in a health technology evaluation, and under which circumstances. This will be done in NICE’s second consultation running from February to March. Such a modifier could consider the types and sources of inequality, as well as how a modifier should be applied—qualitative or quantitative. It could also consider whether such a modifier covers technologies that directly reduce inequalities—for example, by specifically targeting or providing additional benefits for a disadvantaged group; or whether indirect effects might also be considered—for example, if a technology has uniform benefits across groups, but the condition disproportionally affects a disadvantaged group. At this stage, it is not clear that there is sufficient evidence for a health inequalities modifier, but it is being explored, and will be explored further in the second stage.

I hope that level of detail on the consideration that NICE is undertaking helps to reassure the noble Lord, but of course it would not be appropriate to pre-empt that review, and we want to encourage all stakeholders to respond to it.

In addition, I remind the noble Lord that a requirement to have regard to reducing health inequalities is already imposed on NICE under Section 1C of the National Health Service Act 2006. This applies to NICE as a non-departmental public body of the Department of Health and Social Care.

Proposed new subsection 1(c) would require NICE to have regard to the need

“to ensure patients with rare diseases have access to medicines and medical devices”.

The noble Baroness, Lady Wheeler, noted some concern during Grand Committee as to why NICE did not propose a rarity modifier in its methods review. A rarity modifier was considered by NICE prior to publication of the consultation document. However, stakeholders noted that rare diseases would be covered by the proposed severity modifier, which more accurately reflects society’s values. Although there is of course overlap between severity and rarity, not all rare conditions are severe and some severe conditions are more common. Of course, the consultation was an opportunity for all stakeholders to express their views on this point. As noted previously, NICE is also consulting on changes, such as a more accepting attitude towards uncertainty in some situations, which should benefit medicines for rare diseases.

Where there is uncertain evidence relating to a medical technology—I appreciate this can be a challenge for rare diseases—NICE and NHSE&I have developed managed access agreements. NICE has already recommended six topics for use subject to a managed access agreement outside of cancer. NHSE&I continues to use its sophisticated commercial capabilities to negotiate deals with industry that enable patients to access the most innovative new medicines and ensure that the NHS gets good value.

Proposed new subsection 1(d) would require NICE to have regard to supporting

“the use of curative therapies involving medicines and medical devices.”

The word “curative” should be used with caution, as there is no standard definition of what might be meant by it. For example, in some cases it may mean a significant amelioration in symptoms, in others that the treatment pathway is different or more tolerable.

While I appreciate that recently launched advanced therapy medicinal products hold great promise by targeting the specific cell or genetic defect, the data on long-term effectiveness is often immature at the time of marketing approval. Further, we need flexibility to respond quickly and effectively to developments in life sciences. We want to avert a situation whereby an effective therapy is not guaranteed funding because it did not meet the legal definition of a “curative therapy”. However, I think that the noble Lord was more trying to get at our support for some of these innovative approaches. Again, this is being looked at in the review of NICE’s methods.

NICE’s working group has explored whether there is a case for changing the approach to discounting, which the noble Lord asked about, in particular the impact on technologies with long-term benefits such as one-time gene therapies. This is a complex area that needs to take into account the policy-level need to support particular types of technologies or circumstances, the limitations of the current criteria for non-reference case discounting, and the effects and any accompanying policy and affordability challenges of any change. This will be covered by the second stage of the NICE methods review. Again, while we would not want to pre-empt that review, all stakeholders are encouraged to respond to it.

Briefly, proposed new subsection (2) would require the Secretary of State to lay a report and impact assessment before both Houses of Parliament, setting out how NICE has implemented its duty under proposed new subsection (1). As I said in Grand Committee, NICE will publish its revised methods and process manual, including its impact assessment, on its website for all to access, including parliamentarians, once the process has been completed. That is the correct forum.

I will briefly address Amendment 46 in the name of the noble Baroness, Lady Finlay, which touches on similar issues—the importance of access to medical technologies, the future medical devices regulatory regime, and the critical nature of medical device safety. I pay tribute to the noble Baroness’s work through her engagement with Ministers and our officials in developing government Amendment 45, which provides greater clarity on the types of activity we would intend to encourage through appropriate regulation. That includes, in respect of medical devices, carrying out research, developing medical devices, or manufacturing and supplying medical devices.

The Government support the agenda for early access to medical devices for NHS patients, as demonstrated through other mechanisms such as the rapid uptake products programme, managed by Accelerated Access Collaborative, and the medtech funding mandate, due to launch in April.

The second stated purpose of the noble Baroness’s amendment—to allow monitoring of the safety and efficacy of medical devices in real-time use—is already achieved by regulations that may be made under Clause 15(1)(i) and (j), so the mechanism to deliver this is already in place. In addition, Clause 18 empowers the Secretary of State to make regulations for the establishment of a medical device information system by NHS Digital, which will support the monitoring of patient outcomes and patient safety.

The noble Baroness also asked about the timeframe for future devices regulation made under the Bill. I assure her we will consult on this issue this year.

I hope the reassurances I have provided, here and during Committee, are of comfort to noble Lords and that the noble Lord, Lord Hunt of Kings Heath, feels able to withdraw his amendment.

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

My Lords, I wanted to stimulate a debate on the NICE review and it certainly succeeded, because we had a very high-quality debate. I am very grateful to the Minister for what was a comprehensive and encouraging response, in a number of ways.

I will start with the noble Baroness, Lady Finlay, because she made a powerful speech and argued very convincingly for the speeding up of approval processes, alongside speeding up the introduction to the National Health Service of proven, innovative new medicines and treatments. The noble Baroness, Lady McIntosh, asked about patient safety, but my amendment and, I believe, that of the noble Baroness, Lady Finlay, would do nothing to undermine patient safety. In the first place, the Minister has already tabled an amendment to Clause 1, which we debated on the first day of Report, which gives priority to considerations of patient safety. It is clear from the explanation given for Amendment 46 from the noble Baroness, Lady Finlay, that her proposals for a preliminary licence would allow for monitoring of safety and efficacy in real time. That could be a real bonus indeed.

I thought that the noble Baroness, Lady Masham, asked the fundamental question: why are we so slow to introduce new medicines and devices? Why are we behind so many other developed countries?

The noble Lord, Lord Lansley, gave a very thoughtful contribution. He is absolutely right to argue that we need more support for innovative medicine. The tragedy is this. We have the excellent VPAS agreement whereby, essentially, industry accepts that if the cost of medicines goes above a certain agreed level it will pay a rebate back to the Government, or ideally the National Health Service. If this worked properly the resource going back would be used for innovation, but for reasons that I have never quite understood the money does not seem to go back directly in an identifiable form to the NHS. We have the bizarre situation where, locally, the NHS worries about its drug costs. When it goes above a certain level there is a rebate, but unfortunately that rebate does not seem to find its way back in a tangible, transparent form, to the NHS. We have not created out of the agreement the kind of win-win situation that surely was envisaged when the previous voluntary agreement was first developed.

The noble Lord, Lord Lansley, mentioned one of the big issues: the need for NICE and NHS England to work together. I do not get the impression that they do work together that well, because NHS England regards most innovation as costly and therefore tries to dampen it down. I agree with the noble Lord, Lord Lansley: we need a much better partnership where we build in value for innovation and dealing with inequalities—one where NHS England would actually be on board.

The noble Baroness, Lady Jolly, and my noble friend Lady Thornton talked about this being a big-picture debate. Of course, this is not something that can be solved by an amendment to a medicines Bill, but Parliament ought to debate these important issues and, at the very least, raise some issues that the review should undertake to address.

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[Baroness Jolly (LD) [V]]

My Lords, the amendments in this group relate to reporting requirements and consultation. The noble Lord, Lord Hunt of Kings Heath, has just put the political case very clearly; the noble Lord, Lord Patel, looked at the technical and regulatory issues; I will look at the practical issues around health services on the island of Ireland.

Amendment 69 from the noble Baroness, Lady Thornton, would require the Secretary of State to report on regulatory divergence between Northern Ireland and the rest of the UK. Can the Minister tell us when the first report would be published, whether the Republic would be part of this consultation, and if not, why not? The noble Baroness, Lady Thornton, and I tabled this amendment to require the relevant authority to consult with patients and healthcare and industry stakeholders when preparing a report under Clause 44.

Divergence is inevitable. The situation for healthcare on the island of Ireland could become extremely complicated. In the past, patients have travelled north or south to receive treatment wherever the appropriate treatment is available. Will citizens from Northern Ireland and the Republic have to use the new GHIC, or do the Government have an agreement with the Republic so that business as usual will be the new norm—no change?

Government Amendments 75 to 77 and 79 to 85 extend the reporting requirements under Clause 44 so that they apply to regulations made by a Northern Ireland department and in respect of regulations under Clause 18. However, we cannot ignore the Republic when we talk about health in Ireland.

[Baroness Penn (Con)]

My Lords, we now turn to the way in which reports are prepared and made on the exercise of the regulatory-making powers in the Bill.

Amendment 69 in the name of the noble Baroness, Lady Thornton, would make changes to the existing requirement to report, introduced in Grand Committee. It proposes that an additional report be made by the Secretary of State to Parliament, this time on regulatory divergence with Northern Ireland introduced as a consequence of future regulations. I understand the noble Baroness’s intent. I heard the concerns raised in Grand Committee about the potential impact of regulatory divergence. The Government take that seriously. However, I will explain why this amendment is not necessary to address it.

As a reminder, the amendments made in Grand Committee provided for a reporting obligation on the operation of regulations made by the Secretary of State under Clauses 1(1), 9(1) and 14(1)—one that was both forward- and backward-looking. Those reports must include any concerns raised or proposals for change made by anyone consulted by the Secretary of State in the preparation of the report, and the response to these. It will necessarily draw Parliament’s attention to regulations that have been made.

Parts 1 and 2 of the Bill relating to human and veterinary medicines are matters transferred to Northern Ireland. As such, legislative consent was secured for the Bill earlier in its passage, but as amendments were made during Grand Committee, further legislative consent was sought. At Northern Ireland’s request, government Amendments 75, 76, 79, 80, 81, 82 and 85 in this group replicate the existing reporting obligation for Northern Ireland. This means there will be a report laid in Parliament every two years on what new regulations have been made and any plans to make further related regulations. A separate report will be laid before Northern Ireland. Between our report and the report laid before the Northern Ireland Assembly, any areas of regulatory divergence between the UK and Northern Ireland regulatory regimes will be made clear. Therefore, it would be duplicative to require the Secretary of State to lay additional reports specifically on regulatory divergence for human and veterinary medicines and medical devices.

In addition, where there are concerns about the implementation of the protocol and its impact on patients and animals in Northern Ireland, there are formal channels in place. Officials meet regularly in the Ireland/Northern Ireland Specialised Committee. The Specialised Committee reports to the Withdrawal Agreement Joint Committee and provides advice on decisions to be taken by the Joint Committee under the protocol.

Before the end of the transition period, we raised with the EU through its specialised committee the issue of the falsified medicines directive and regulatory importation requirements for medicines moving from Great Britain to Northern Ireland after 1 January. We agreed with the EU a pragmatic one-year, time-limited approach to implementing these regulations that ensures no disruption to the flow of medicines to Northern Ireland. I say this to reassure noble Lords as to the effectiveness of those mechanisms under the protocol.

Noble Lords made a number of comments on the issue of regulatory divergence and I thought I would dwell on it briefly. The noble Lord, Lord Patel, gave a good description of future provisions regulating devices between Northern Ireland and Great Britain. He is wrong to say that the Bill lays out Northern Ireland separately because of this. It does so because medicines and veterinary medicines in Northern Ireland are the responsibility of the Northern Ireland Assembly and are therefore devolved. However, divergence may be an issue for the future, not least because the EU may change its own regulatory regime under the protocol that Northern Ireland will follow, and the UK may make changes here as well.

To reassure noble Lords, we have agreed a standstill period of two years for medicines and veterinary medicines and two and a half years for devices, during which we will continue to recognise EU regulations in these areas. This means that there is time for adequate consultation on regulations made under this Bill, for consultation on any future changes and for these mechanisms to operate properly. Divergence may be a matter for the future, but we have reporting to Parliament and public consultations on any regulations made under this Bill to address those questions.

The noble Lord, Lord Hunt, asked how we ended up here. I think that question is slightly wider than the purview of this Bill. I have quite a lot of lived experience of how we ended up here and I do not intend to recount that now.

I hope the amendments I have referred to in the name of my noble friend Lord Bethell, coupled with these other, existing arrangements, make the amendment tabled by the noble Baroness unnecessary.

Government Amendments 77, 83 and 84, also in the name of my noble friend, are made in the same light of expanding reporting obligations. In the interests of transparency and scrutiny, amendments have been made to extend the obligation to include regulations made under Clause 18—the regulation-making power in relation to the medical devices information system. We have made this change to make clear our absolute commitment to transparency, to giving Parliament continued visibility, to understanding the assessment made of any proposals or concerns raised as to how the regulations have been working, and to ensure that the regulation-making powers specifically containing provisions that may ensure or affect device safety and post-market surveillance are treated equally.

The noble Baroness, Lady Thornton, again seeks to test us on the preparation of the reports with Amendment 78, which would add a list of stakeholders to be consulted under the obligation. Again, this is unnecessary. If her concern is that the stakeholders listed may be ignored, I reassure her that the reports must summarise concerns raised, or proposals for change made, in relation to regulations enforced during the reporting period. That information will come from engagement with relevant stakeholders. Therefore, I do not think it necessary or proportionate to add a list of specific stakeholders to be consulted for each report, which will be a summary of public consultation that will already have been responded to.

I must say to the noble Baronesses, Lady Jolly and Lady Wheeler, that the Government will not return to this issue at Third Reading, so if they wish to press it, now is the moment. However, with the number of avenues already available, I hope that they are reassured that their amendment is not needed and will not wish to press it.

[Baroness Wheeler (Lab)]

I thank the Minister for her response. I shall not go into details now, but we know that there will be significant issues of regulatory divergence, as the noble Lord, Lord Patel, my noble friend Lord Hunt and the noble Baroness, Lady Jolly, have stressed. We know that it is an issue about which we will have to be very watchful. In the circumstances we currently face, an annual report would have aided the process of working through the issues and encouraged understanding of the plans to address them and the progress being made.

On Amendment 78, the Minister is obviously not going to oblige me with a tidying-up amendment at Third Reading to underline the importance of the patient voice. I think that is a mistake; it would have been helpful. However, I beg leave to withdraw Amendment 69.