HIV: Pre-exposure Prophylaxis

Baroness Thornton Excerpts

Tuesday 1st December 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, the noble Lord makes a completely fair point. There is absolutely no question of there being a social stigma associated with taking PrEP or any kind of moral cloud over those wishing to take this important therapy. That is not in any way our purpose. He makes a valid point that there are good arguments for the supply of PrEP to be not just through GUM units but also through GPs and perhaps pharmacists. These are arguments that we hear and that we are looking at very closely. I hope that, at some point, I will be able to update the noble Lord on our progress on this matter.

[Baroness Thornton (Lab)]

I remind the Minister, with regard to his last answer about funding, that just because you cannot solve all the world’s problems does not mean that you should not try to solve some of them. On that basis, can the Government provide an update on the rollout of PrEP in England? Is the Minister aware that there are local authorities that are still not providing the drug? When the ring-fenced funding for PrEP runs out in March 2021, will the Government commit to at least the £16 million per annum to make this happen for the future?

[Lord Bethell (Con)]

The noble Baroness makes a fair point. The rollout of PrEP has reached a great many local authorities but not all of them. The funding for it, at £11 million, has made a big impact but it has not covered all the ground. We are aware that this funding package runs out next year and we are in active engagement with local authorities in order to find a new mechanism going forward before July, when the funding will change. That said, our commitment, as I said earlier, to the principle of PrEP and its impact on reaching our targets for transmission remains resolute. I look forward to being able to announce a resolution of this funding formula.

Health Protection (Coronavirus, Restrictions) (All Tiers) (England) Regulations 2020

Baroness Thornton Excerpts

Tuesday 1st December 2020 Lords Chamber

[Baroness Thornton (Lab)]

Perhaps I may say how pleased I was to see the noble Baroness, Lady Brinton, in the Chamber today, joining in our debates.

I thank the Minister for introducing these very important regulations to the House. I hope that he, like me, does not feel too second division, as the debate in the other place was opened by the Prime Minister and the leader of the Opposition, but I am sure that he and I can probably do more than justice to this subject. I think that his right honourable friend the Prime Minister might be feeling just a little worried at the moment because I gather that he had 56 rebels on the vote that has just taken place in the Commons.

This statutory instrument sets out that the Secretary of State must review whether each area that is part of tier 2 or tier 3 should continue to be part of those tiers at least once every 14 days, with the first review to be carried out by 16 December 2020, and review the need for each of the tier 1, tier 2 and tier 3 restrictions at least once every 28 days. The first review is to be carried out by 30 December 2020, so I hope that the Minister will have some Christmas. The shame of the statutory instrument is that it offers a binary choice. If this were primary legislation, we could really test the legitimate concerns in a way that we are not able to do this evening. The regulations will expire on 2 February 2021. I urge the Government to think very carefully about how the discussion on renewal, or whatever happens next, takes place. We are many months into this regulatory review; I think it is time that it ended and we had proper primary legislation.

The allocation of the areas of the revised tiers was announced on 26 November. As the noble Baroness, Lady Hayman, said in her very wise contribution, it has cemented the deep sense of divisiveness in the nation. The Government have published information alongside a Written Statement which sets out the rationale behind the allocations. Many noble Lords have already criticised that, so I will not go into detail on it. However, it means that tier 1, which had 23.5 million people in it pre-lockdown, now has 713,000 people, and tier 2 now covers 32 million people whereas it previously covered 24 million. So it is not surprising that people are concerned about where they have been put.

The new map of the three-tier system in England looks very much like a depiction of the north-south divide, and as Danny Dorling, the Oxford Professor of Human Geography, said on Saturday:

“What’s certain is that the key to understanding the map is the underlying social and economic geography of England. To understand the changing medical geography of this pandemic, you must first understand how the country lives and works”.


There is the rub. If the Government do not have a real understanding of how people live their lives, the conditions under which they work, the security or otherwise of their jobs, the adequacy of their homes, the transport they rely on, their relationship with schools and local facilities and their reliance on informal support networks, it is difficult to see how the current proposals and the ones that have gone before can work effectively.

The combination of vaccines, mass-scale rapid turnaround testing and therapeutic advances offers a way out of the current Covid-19 challenges in the spring and early summer, but in the meantime, restricting social contact is the only way of reducing the pandemic, protecting our National Health Service and allowing it to do its job, as my noble friend Lord Hunt and the noble Baroness, Lady Watkins, explained. We can see some success, and I applaud that, but the Minister needs to understand that many people believe that the success in getting the R rate down has been achieved despite the Government and not because of them. Why do we need to be still learning the lessons of being too slow?

It is of course welcome news that the R rate is below one, but today we learned what that means—and it does not mean that we can return to any sort of normal life. The news on the vaccines is of course tremendously good. Like others, I am allowing myself to hope that one day I will be able to see my sisters, nieces and nephews in Yorkshire and to hug people. I am also hoping not to have to queue for the supermarket, and maybe I will be able to sit at the same table as my noble friend Lady Wheeler in the Guest Dining Room, rather than sitting six feet apart at separate tables.

However, we have been here before: overpromising and underdelivering. As my right honourable friend the leader of the Opposition said, we are now on plan 5. The slowness with which we have entered these different plans is the reason why the UK economy has been hit particularly hard. As the OBR reported, a sharp slowdown in activity meant that the UK experienced one of the larger falls and that activity was then slower to recover.

The shame of this is that the Government learned none of the lessons from the first wave of the crisis and failed to listen to SAGE—or to Labour, when we argued for a two to three-week circuit-break to coincide with half term. Instead, we have had a longer national lockdown and the economy has taken a bigger hit.

It is therefore vital that the tiers work, and that the relaxation of Christmas does not lead to a further spike and lockdown in the new year. How could that be done? We have a few ideas. We need to end the topdown, centralised model of testing, tracing, isolating and supporting. Local teams with local knowledge must be put in charge, and they must be given the resources to do the job. We need to get rid of Serco and give the testing, tracing, isolating and supporting to our local teams. Frankly, if the Government have spent £22 billion on this and it is still not working, there has to be an alternative.

We need to ensure routine testing for all high-risk workplaces and high transmission areas for NHS and care staff, of course, but those in retail, hospitality and transport, teachers and pupils in secondary schools should also have access to tests whenever they need them.

Furthermore we need to overhaul the failing support for self-isolation, for both businesses and individuals. We need to support our businesses. The Government’s approach to supporting areas under local restrictions is fundamentally unfair and risks a gulf in support opening up across the country. The idea that the Isle of Wight should receive the same amount of support as Manchester is patently unfair.

Businesses are in the dark about the future of the furlough scheme, which is up for review in January. What will happen next? The Chancellor is still refusing to help millions of people excluded from his support schemes for the self-employed, despite having had months to plug those gaps.

What about our students? What will be the impact of their return home before Christmas? What is the Government’s assessment of the risk of students contracting the virus between having the test—which I hope will be available in the universities—and returning home? What steps are the Government taking to ensure that transport capacity is not overwhelmed by the numbers of non-socially-distanced travellers next week? It is completely irresponsible for the Government to leave tier 3 areas across the north and the Midlands in the lurch again.

What about Christmas? What is the scientific assessment of the risk that five days of relaxation will entail? I raised this matter yesterday with the Minister, and I am still seeking an answer. Covid-19 cases have spiked across Canada in the past month, since Thanksgiving and Halloween. On 12 October, Canada had 185,000 Covid cases. Only six weeks later that number has nearly doubled. Canadians and Americans alike are saying that the surge is proof that nothing is worth the risk. I would, therefore, like the Minister to address this issue: what will the cost of Christmas be in infections?

Does the Minister believe that the three-tier system provides for the necessary post-Christmas restrictions, or is a third lockdown inevitable? Given the prediction that cases will increase after Christmas, what plans are in place to prepare the NHS and safeguard services in the coming months, until a vaccine allows life to return to normal? Front-line resilience is already at a premium and will be critical over the next weeks and months, particularly after Christmas, especially if we do not wish to look back on those activities with very deep regret.

With regard to the amendments to these Motions proposed by the gaggle of Conservatives, I sort of feel sorry for the Minister. It is noticeable that yet again the Government find themselves under fire from their own side. As I have said at least twice to the noble Lord, Lord Robathan, he has form in being a Covid restriction objector and seems prepared to risk people’s lives instead of supporting them to do the right thing. This is my view of the noble Lord’s—

[Lord Robathan (Con)]

It is wrong.

[Baroness Thornton (Lab)]

Well, that is my view; I think it is right. I think that is what will happen if he gets his way. The noble Lord does not seem to understand that, until his Government actually manage to build and support the systems that will contain the virus, particularly in deprived communities, his proposal would only cost lives—and they will be the lives in our poorest communities, the BAME and the vulnerable.

I believe the other two are legitimate regrets and at least show consistency from the movers. However, as we have in the past, we on these Benches will abstain if any of the movers choose to test the opinion of the House.

Covid-19 Update

Baroness Thornton Excerpts

Monday 30th November 2020 Lords Chamber

[Baroness Thornton (Lab)]

I thank the Minister for taking this Statement, and I look forward to discussing the regulations that will flow from it tomorrow, if they successfully pass through the Commons. Although we can see that cases are going down—and that, of course, is a matter for celebration and relief—we are still seriously in the pandemic. We still seriously stuck in what seems like an endless cycle of lockdowns, which have not been working.

The Government have again wasted the opportunity, over the past few months, to get a handle on testing, tracing, isolating and supporting. Once again the hospitality industry in many parts of the country will be absolutely battered. Once again jobs will be in further jeopardy. Once again our theatres are closed. Once again older people, disabled people and people with learning difficulties remain stranded in care homes without visits from their families. Exactly what will be the difference this time that will make people’s sacrifices yield a reduction in the infection rates? When shall we see testing in care homes, for example?

Reflecting on the debate in the Commons following the Prime Minister’s and the Secretary of State’s announcements last week, we see that all MPs of all parties were desperate for two things. They were desperate to understand the basis on which these decisions were being taken, and they were desperate to understand how their constituents might be able to move from, for example, tier 3 to tier 2, or tier 2 to tier 1.

As my honourable friend Rachel Hopkins MP says:

“The good people of Luton will want to get out of tier 2 as soon as possible, but the current resources provided to Luton Borough Council for the lateral flow rapid testing pilot are insufficient to enable it to provide the level of mass testing that is being described nationally. The contained funding—£8 per person—just will not cover tests for 10% of Luton’s population, as the funding also needs to be used for the wider covid response, including wellbeing support for vulnerable residents.”


She asked the Secretary of State, and I now ask the Minister here, to

“confirm that there are national plans to provide additional support and resources to expand testing if the intention to test close contacts daily is pursued”.—[Official Report, Commons, 26/11/20; col. 1012]

The news about the vaccine is the light at the end of the tunnel, but noble Lords must be well aware that we are still well into the tunnel, and probably will be for months to come. The only sure way to contain the virus is for people to obey personal rules and, most crucially, for us to have an effective and locally controlled test, trace, isolate and support system. We on these Benches have known this and have been asking, if not begging, for the last part of this deal for many months. Despite the Minister’s constant issuing of large numbers one way or the other, it is still not working as it should be. It is not surprising that confidence in the Government’s ability to deal with the pandemic is at a low ebb, much lower than in March and April.

Yesterday I heard the Conservative Rother Valley MP Mr Stafford say on television that he thought we were in trouble with this virus because people had broken the rules—in other words, let us blame the public. He was taken to task firmly by my honourable friend Naz Shah MP, but I have to ask the Minister whether he agrees with his colleague Mr Stafford.

When areas such as Bury and Trafford went into lockdowns in the summer, the Secretary of State promised that MPs would be involved in the decision. Has that commitment now been abandoned? Then Ministers agreed to involve regional leaders but, it has to be said, took exception to being challenged by Andy Burnham. What role do regional leaders now have in these decisions, or is the position really that the Prime Minister imposes from Downing Street restrictions on communities across the Midlands and north that will have huge impacts on the livelihoods of families and small businesses? What are the plans to alleviate the hardship that these rules will create? Leicester, Bury, Leigh and Heywood have been under a form of lockdown for months, with families forced to part and grandparents not seeing their grandchildren. Those families will want to know today what the exit strategy is and what voice they have in that strategy.

The Secretary of State in this Statement has outlined five criteria by which local lockdowns will be judged. Will that be published, with clear, transparent rules for areas entering and leaving tiers and a scorecard for every area, assessing its Covid progress against its criteria so that everyone can judge this in a transparent fashion?

What have the SAGE advisers said to the Minister about the risks which go with the proposed lifting of restrictions for Christmas? The Canadians have a very clear message about this. They say, “Stay home and stay safe”, and the reason they say that is because the worst surge in Covid-19 they have ever experienced followed six weeks after their Canadian Thanksgiving. They have given warning to their southern neighbours—the United States—that they will see an even bigger and more devastating spike following their annual gathering for turkey and gratitude at Thanksgiving. This is a warning that we need to heed. Does the Minister agree?

[Baroness Jolly (LD) [V]]

I thank the Minister who is going to respond to this Statement.

The first case of this coronavirus was just over a year ago, on 17 November 2019. Since then, over 1.3 million people have died worldwide and over 50 million people have been infected. The first case here in the UK was on 29 January this year. We watched Italy deal with the cases in late winter, and I am sure that plans were being fetched out of the archives on how we might deal with a pandemic. I know that in 2015 there was a pandemic plan published for an influenza outbreak. Will the Minister tell the House what lessons were learned from that exercise?

I remember walking back to my flat in London on 17 March and my son, who was living with me then, said, “You either go home today, or you stay until this clears”. I went home, and on 23 March lockdown started. Along with many other noble Lords, I stayed away for some considerable time, and Zoom, Teams and virtual working became the new normal.

Hong Kong, which is always waiting for a SARS outbreak, keeps a stock of PPE for all care homes in the event of a pandemic. Is it too early to ask the Minister whether that is something he would now consider for England? I think it was a recommendation of that pandemic preparedness document in 2015.

One area where I would also be grateful for clarification is that of test, track and isolate. At what stage was it decided not to involve the local experts and local authorities? This caused much regional frustration, as this was the biggest public health crisis for many years, and local public health leaders were being sidelined. They know their regions well, and in areas where they did work, it worked well. Let me be clear that in a Lib Dem world, local authorities would test then track those with a positive result and support them practically and emotionally in their isolation.

As the noble Baroness, Lady Thornton, has articulated, many of the public have said that they did not fully understand restrictions. When putting messages together, who did the Government picture they were talking to? From whom did they get their advice? Who did they test their messaging on? This is a case where conversations with the Plain English Campaign, or perhaps the Canadians, would have been helpful.

The last time tiered restrictions were in place, less than half of people in the UCL Covid-19 Social Study said that they fully understood the rules. With changes to the tier system and a five-day relaxation, will the Secretary of State make changes to the Government’s communications strategy to aid compliance?

Some of the Covid economic measures have helped people in the short term, such as the furlough scheme, which our colleagues in the other place fought so hard to get. However, the Government excluded more than 1 million people from Covid support and froze pay for local authority staff, who have also played a vital role in combating this pernicious disease. It is an assault on local authority workers and services.

Nurses too have been hoping for a pay rise. The Chancellor stated:

“Our health emergency is not yet over and our economic emergency has only just begun”.


He explained that the

“immediate priority is to protect people’s lives and livelihoods”,

and that the spending review is set to deliver stronger public services. He continued:

“taking account of the pay review bodies’ advice, we will provide a pay rise to over a million nurses, doctors and others working in the NHS.”

He promised

“the 2.1 million public sector workers who earn below the median wage of £24,000”

that they

“will be guaranteed a pay rise of at least £250.”—[Official Report, Commons, 25/11/20; cols. 827-28.]

That should include porters, auxiliaries, and other key, low-paid hospital workers.

Countless families are facing serious financial hardship. More than 1 million people have lost their jobs, and the devastating impact of this pandemic will continue to be felt acutely throughout the next year. We are also facing big challenges in deep-seated inequality. We must ensure that no one is left behind. The Government win plaudits for the furlough scheme, but they have failed to provide a serious economic strategy for dealing with unemployment, climate change and inequality. I fear the Government’s Brexit plans will make job losses and business closures much worse. No deal or a bad deal would be a huge blow for businesses and jobs just when we need to be recovering from this crisis.

Although the winter plan broadly outlines the five criteria used for determining the tier system, would the Minister be more transparent about what the exact entry and exit points of the tiers will be? I understand it is not always possible to give exact criteria, but even a rough idea would help the public know what they are aiming for when the Government are asking them to make so many sacrifices.

This has been relentless since the middle of May. At a briefing meeting today, we heard that the acute care sector was at full pelt, and this is before winter sets in. The Minister is rightly proud of the Nightingale units. Do we have staffing for them? Should we need them? Many clinical staff are totally exhausted. Many question whether they want to carry on in the profession. Are the Government making sure that a safety-critical profession can reach safe staffing levels by filling tens of thousands of unfilled nursing jobs?

Children are the most vulnerable to the social impacts of local restrictions and have had formative years of their lives severely affected. With the rule of six being reinstated after national lockdown, will the Minister commit to an exemption from the rule of six for children under 12? It really does make sense.

What is the Minister’s current estimation of the likely length of the restrictions? Being open and transparent on likely timings and not creating false hope are critical to maintaining public support for any public health measures. After all, the PM said earlier this year that we would be back to normal by Christmas, and how wrong he turned out to be.

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

Baroness Thornton Excerpts

Wednesday 25th November 2020 Grand Committee

[Baroness Thornton (Lab) [V]]

I am very pleased to agree with the Minister on this statutory instrument, but I first welcome my noble friend Lord Davies of Brixton and congratulate him on his maiden speech today. He and I have known each other for many years, but have not really seen each other for probably the best part of 30 years. We hark back to the days when I was the chair of that venerable Labour institution the Greater London Labour Party, and my noble friend was a leading member of the GLC and the Inner London Education Authority. A couple of abolitions, many general elections and a Labour Government later, here we are in the House of Lords, and in probably its strangest state in its whole history. I welcome my noble friend; he is one of the very smartest people, and an actuary, as he says—the first here—and will, I am very sure, bring great value to our deliberations. And he should not worry: there will definitely be another pensions Bill along very soon.

When we were putting this emergency Covid legislation on the statute book in March, the easements that are the subject of this statutory instrument were the cause of much concern, because they concerned people’s liberty and human rights, which should not be put aside lightly, if at all. That is what we were saying at the time. They would have increased the amount of time that someone could be detained, decreased the number of qualified people required in the detainment procedure and weakened the Mental Health Act 1983 protections, if brought into force. I am grateful, like other noble Lords, for the excellent brief by the Law Society and its support for these regulations.

We recognise that, at the onset of the pandemic, these exceptional emergency provisions were considered potentially necessary to support healthcare professionals in responding to the immediate crisis. As they have not been used in England to date, they should indeed be expired—so I congratulate the Minister—and thus restore the full certainty of important statutory protections for vulnerable people. I add my thanks and gratitude to the mental health staff who have made things work so successfully under the most difficult conditions that we are able to put aside this part of the Coronavirus Act.

Are the Government considering expiring the provisions under Schedule 12 to the Coronavirus Act alongside the expiration of the provisions under Schedule 8 to the Act implemented by these regulations? As noble Lords will know, Schedule 12 makes modifications to provisions under the Care Act 2014 and Social Services and Well-being (Wales) Act 2014, allowing local authorities to suspend their statutory duties to assess, develop and review individuals’ care plans, carry out financial assessments, and meet care and support needs. Local authorities must still carry out the above where a failure to do so would breach obligations under the European Convention on Human Rights but, for the majority of vulnerable people in the care of local authorities, this high bar provides little to no protection.

Six months on, it is deeply worrying that the Government still envisage the need to enact this watering down of conditions. Can the Minister provide an update on the number of times that these provisions have been used, why they were enacted and what impact they have had on residents? Can he provide assurances that provisions within this Act for care homes are not currently being enacted and describe the conditions under which they might be used?

We are of course still finding out the mental health cost of Covid, and it is disturbing that the Chancellor and Secretary of State for Health refer to the additional funding that the NHS needs to catch up on the cost to patients and treatment of Covid, but do not make the same commitments for social care or mental health. That is of great concern and is very short-sighted, as my noble friend Lord Hunt said. When will we see the results of the Mental Health Act review and promised reform, as the noble Baroness, Lady Barker, mentioned? We need to give more attention and resources to mental health.

A study from researchers at Oxford University found that nearly one in five people who has had Covid-19 was diagnosed with a psychiatric disorder—such as anxiety, depression or insomnia—within three months of testing positive for the virus. Not only do we have immediate issues, there are many coming down the track.

Covid-19: Vaccination Prioritisation

Baroness Thornton Excerpts

Wednesday 25th November 2020 Lords Chamber

[Lord Bethell (Con)]

I am extremely grateful to the noble Baroness for suggesting the New York precedent. It is not one that I was aware of and I will look into it. I reassure her that we are liaising with all our international partners over the vaccine rollout to ensure that we put in the best possible practice that we can.

[Baroness Thornton (Lab) [V]]

My Lords, I have read the JCVI priority list. As the Minister has indicated, some granularity is going to be vital. There is so far no mention of vulnerable BAME communities, who have borne the disproportionate burden of the pandemic. How will the Government approach those vulnerabilities in setting the priorities and their implementation?

[Lord Bethell (Con)]

My Lords, the underlying principles of the advice of the JCVI are to reduce mortality, to improve population health by reducing serious disease and to protect the NHS and the social care system. The basic insight is that the risk of serious disease and death from Covid increases exponentially with age and increases in those with a number of underlying health conditions. Those are the basic principles of the interim advice and they will evolve over time.

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

Baroness Thornton Excerpts

Wednesday 25th November 2020 Grand Committee

[Baroness Thornton (Lab) [V]]

I thank the Minister for introducing these regulations. I agree with the noble Baroness, Lady Ritchie, that the documentation was both clear and comprehensible. I also compliment her on her command of these issues, which is of course entirely to be expected.

As the Minister set out, these are important regulations that largely make technical changes to retained EU law so that references to the UK become references to Great Britain instead. This is because the Department of Health in Northern Ireland will not have the same functions transferred to it as the rest of the UK, and the amendments will therefore ensure that EU law continues to apply in Northern Ireland and that EU retained law in England, Scotland and Wales will therefore be effective.

Needless to say, while we recognise that these regulations are necessary and reflect the Northern Ireland protocol, they contravene some of the countless commitments made by the Conservative Government on the treatment of Northern Ireland. What would be the effect of this SI if the Government had their way on the United Kingdom Internal Market Bill, currently being voted on in the Chamber, and threw the international agreement and protocol out of the window? What would happen to measures such as this statutory instrument?

I understand that the devolved Administrations were involved in the drafting of this instrument, as is quite correct. Can the Minister confirm whether the UK is centred on maintaining existing standards and promoting common approaches to nutritional policy going forward? I agree with the important questions posed by all noble Lords, particularly the noble Lord, Lord Bourne. What assessment have the Government made of other potential future divergences which might arise from, for example, UK food labelling? What safeguards are in place to prevent regulatory divergence? We know that labelling specifically is a critical concern for food and drink manufacturers in Great Britain and Northern Ireland. As has been outlined, we will have different trading rules in Great Britain and Northern Ireland from 1 January. There is a great risk that labelling use in Britain will no longer be legally recognised in Northern Ireland or on the continent. I hope that the Minister can assure the Committee that that will not be the case. This is because it is quite possible that there may be food labelling regulatory divergence between the EU and Northern Ireland and Great Britain after the end of transition. Much will depend on trade deal negotiations, which may very well require regulatory alignment, including requirements for food manufacturers exporting across the channel to update their food labels for products placed on the UK or EU market.

This is not a long lead-in time. Does the Minister recognise the impact that delays in negotiations have had on operators? Is he confident that operators will have enough time to apply these changes, especially given the additional workplace challenges many have faced due to Covid?

It is also conceivable that there would be the political will to change current EU laws where there are particular public health concerns in the UK, including measures around, for example, addressing the obesity crisis by requiring calorie contents in alcoholic drinks. Given the link between Covid-19 risk factors and obesity, for example—and that is a good example—will the Minister confirm whether the Government have any such plans to deal with that kind of eventuality?

DHSC Answers to Written Questions

Baroness Thornton Excerpts

Wednesday 25th November 2020 Lords Chamber

[Baroness Thornton (Lab) [V]]

My Lords, earlier this week, there were 149 outstanding Written Questions addressed to the Department of Health and Social Care on the Lords business paper. My first question, therefore, has to be: when will they be answered?

One has to wonder about the quality of the Answers. On 21 July, my noble friend Lord Bassam asked a perfectly reasonable Question about

“how many COVID-19 tests have been sent by post and subsequently returned to laboratories, for each day since the scheme began; and how many of the tests sent by post have been discounted because swabbed material was not collected correctly.”

The Answer arrived today—25 November. It says:

“The information is not collected in the format requested”.


You have to wonder why a non-answer took so long to arrive. Does the answer possibly lie partly in the existence of the Cabinet Office clearing house? Are Written Questions subject to a clearing house process—something that many regard as part of a wider obstructive approach to disclosing information? Can the Minister tell the House whether he and his department are involved in referring things to the clearing house at the Cabinet Office?

Medicines and Medical Devices Bill

Baroness Thornton Excerpts

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

[Lord Sharkey (LD) [V]]

My Lords, Amendment 121 is another recommendation, as we have heard, from the Cumberlege review. We would, within three months of the Bill being passed, set up a task force to implement the recommendations of the Independent Medicines and Medical Devices Safety Review. This particular recommendation, like the others in the review, received very widespread support at Second Reading, and a key element of the recommendation contained in this amendment is the appointment of an independent chair of the task force. It is absolutely critical that this independence is real, and perceived as being real. It should be clear to all that the chair is not an establishment place-person, and is an obviously safe pair of hands. It is vital that public confidence in the safety of medical devices be restored, and we very strongly support this amendment. This amendment is the means—and perhaps the only means currently available to us—of making the Cumberlege recommendations a reality. If the Minister is not inclined to accept this amendment, I hope that the noble Baroness, Lady Cumberlege, will bring it back on Report, so that we can test the opinion of the House.

[Baroness Thornton (Lab)]

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

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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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[Lord Sharkey (LD) [V]]

My Lords, I can be very brief. Amendment 122, in the names of the noble Lord, Lord Hunt of Kings Heath, and the noble Baronesses, Lady Cumberlege and Lady Bennett of Manor Castle, would require the Secretary of State to bring proposals before Parliament to establish a redress agency for those harmed by medicines and medical devices.

The arguments advanced for this by the noble Lord, Lord Hunt, the noble Baroness, Lady Cumberlege, and others, seem completely and obviously convincing, and we strongly support this amendment. We have not spoken to its proposers about this, but we wonder whether this redress agency might be hosted by the patient safety commissioner. We also wonder whether the amendment perhaps ought to be reworked into a revised task force amendment for Report, as we discussed in the previous set of amendments.

I know that the Government are in resistance mode about the patient safety commissioner but, when he responds, could the Minister tell the Committee what coherent arrangements there currently are for NHS patient redress, and whether he believes these arrangements are satisfactory?

[Baroness Thornton (Lab)]

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

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

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

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

[Lord Bethell (Con)]

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

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

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

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

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

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

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

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

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[Lord Sharkey (LD) [V]]

My Lords, this is a probing amendment; its purpose is to allow the Minister to explain why Clause 44 contains four different commencement provisions for different parts of the Bill. The Explanatory Memorandum is silent about the reasons for that. I would be grateful if the Minister could explain on what basis the paragraphs in subsection (1) were chosen, why the coming into force of the items in subsection (2) is delayed by two months, and, in subsection (3), why Chapters 3 and 4 of Part 3 come into force at the absolute discretion of the Secretary of State. I think that I may understand subsection (4), but it would be helpful if the Minister could explain that to us too for the record. I beg to move.

[Baroness Thornton (Lab)]

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

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

[Lord Bethell (Con)]

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

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

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

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

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

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

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Moved by

[Baroness Thornton]

146: Schedule 1, page 34, line 10, leave out “have regard to” and insert “act in accordance with”
Member’s explanatory statement
This amendment places a duty on the Secretary of State to follow, rather than have regard to, guidance.

[Baroness Thornton (Lab)]

My Lords, we have reached the final amendment so I will be as brief as I can. The first thing I need to clarify, and I do not know if other noble Lords have spotted this, is that my amendment is actually to page 32 not page 34, otherwise it makes no sense at all. It is to amend line 10 on page 32—of the Bill that I have in front of me, anyway. But maybe I have an old copy of the Bill. Paragraph 13(7) of Schedule 1 says:

“The Secretary of State must have regard to the guidance or revised guidance published under this paragraph in exercising functions under this Schedule.”


That is the point of this tightening-up amendment, which would require the Secretary of State to “act in accordance with” the guidance.

Amendment 146 is about the planned civil sanctions regime for medical devices. Part 5 of Schedule 1 provides that the Secretary of State must “prepare and publish guidance” on

“the sanctions that may be imposed on”

someone who commits an offence,

“the action that the Secretary of State may take”,

and the circumstances in which they may take such action. This could be, for example, when a penalty may or may not be imposed, the amount of such a penalty, what the Secretary of State will take into account in determining that amount and so on. Before publishing the guidance the Secretary of State will, of course, consult devolved Administrations and anyone else they consider appropriate. Where necessary, should changes be needed, the Secretary of State must revise the guidance and publish the revised version.

Once published, this guidance is the information that will be in the public domain on the operation of this regime. Yet after all that preparation, as currently drafted, the Bill says the Secretary of State must only “have regard to the guidance” when “exercising functions under this Schedule”. The amendment would simply tighten this up, so that the Secretary of State must “act in accordance with” the guidance. I look forward to the Minister’s response, and I hope we can locate it in the right place—I obviously have an old version of the Bill in front of me.

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

The amendment proposed is to page 34, possibly corrected by the noble Baroness, Lady Thornton, to page 32.

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

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

[Baroness Thornton (Lab)]

First, I need to say that I do have an old version of the Bill which I picked up from my desk on my way here, so I apologise to the Committee for that. I will read the Minister’s comments, but if the schedule already has, as I understand it, the ability to be flexible written into it—I think the Minister said that it was there in Clause 13—it seems to mean that one does not need to have regard to it. One would need to act in accordance with it, because the Bill already has built into it the flexibility needed under the circumstances that he was describing. However, I will read his comments and reflect on them. I beg leave to withdraw the amendment.

Amendment 146 withdrawn.

Covid-19: Conflicts of Interest

Baroness Thornton Excerpts

Wednesday 18th November 2020 Lords Chamber

[Lord Bethell (Con)]

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

[Baroness Thornton (Lab)]

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

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

[Lord Bethell (Con)]

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

Medicines and Medical Devices Bill

Baroness Thornton Excerpts

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

[Baroness Jolly (LD) [V]]

My Lords, I particularly welcomed the remarks of my noble friend Lady Burt, as they took me back to the days in the 1990s when I taught IT. I taught A-level students the differences between databases, tables and registers. I totally support these amendments about registries and databases relating to medical devices. They form one of the key recommendations of the review of the noble Baroness, Lady Cumberlege, in light of the scandals relating to, for example, vaginal mesh.

A huge number of patients have been affected by these incidents, and introducing registries allowing the use of implantable devices to be tracked, and allowing patients to view information relating to the data stored, would make a huge difference. Amendment 95, from the noble Baroness, Lady Finlay, changing “may” to “must”, is designed to seek assurances from the Minister that the Government will proceed to make regulations under the Bill setting up the new information system envisaged by Clause 16.

Amendment 96, in the name of the noble Baroness, Lady Thornton, is a probing amendment seeking clarity about whether the Government intend to track all medical devices used in the UK, rather than a selection. Amendment 99, in the name of the noble Baroness, Lady Finlay, seeks to make mandatory the list of specified issues for regulations to cover. Her Amendment 100, to which I have added my name, would allow for the creation of a system of information regarding implants, with appropriate consents and oversights. It would also allow a patient’s experiences to be reported and stored; they should be subject to oversight. The noble Baroness, Lady Finlay, has also included the point about patient experience in her Amendment 101.

Amendment 104, in the name of the noble Lord, Lord Lansley, would require regulations under this section to have regard to the Caldicott principles. It was just over 20 years ago, when I was a non-exec director in a local NHS trust, that these principles were first introduced. I can remember the way that clinicians—in particular, senior clinicians—really welcomed the new measures. They certainly changed the way that clinicians thought about information and data. We are now moving through a different step change.

Finally, my noble friend’s Amendment 107 would require the introduction of a registry for patients who have had surgical mesh implanted. Though I appreciate that this looks retrospective, there should be data held in hospital databases that could be imported into the new registry. It would then give a complete overview of surgical mesh implantations. It would require the Secretary of State to report on progress towards creating databases relating to other devices or implants and how they would lead to the creation of registries.

Like other noble Lords, we favour registries as opposed to databases because, according to the Cumberlege review, registries act as a repository for more complex patient-related information datasets, enabling research and investigation into patient outcomes. A database is really just a three-dimensional table held in store, but a registry is a richer, more useful resource than a database. However, often a database is required before a registry can be created, which is why our amendment is framed in that particular way.

[Baroness Thornton (Lab)]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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[Baroness Jolly (LD) [V]]

I support Amendment 108, led by the noble Lord, Lord Patel, which would place a duty on the Secretary of State to disclose information they hold

“relating to a medical device where there is a clear threat to public safety.”

Amendment 114, also in the name of the noble Lord, Lord Patel, would retain Regulation 3B of the Medical Devices Regulations 2002, which was inserted by the Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 and, among other things, requires the 2002 regulations to comply with the Data Protection Act 2018.

I support these amendments but wonder what might be the process to contact patients in the event of a fitted medical device fault, which might lead to a threat to public safety if it was more than just one. Would it be the same sort of process as that for recalling certain faulty domestic appliances, which, by law, also need to be recorded? Noble Lords may chuckle, but there is a system there. Where the patient has a medical device implanted, who is responsible for taking patient contact information?

More importantly, how does the patient ensure that their contact data is up to date? Will it link, using the unique patient reference number: their 10-digit NHS number? It would need the patient to ensure that their personal data is kept up to date via the website or app. Many do use the NHS app, but, given the patient demographic, I would not be that confident in relying on that mechanism. I am not sure that the general public are ready for that requirement or, in many cases, have the capacity or devices to fulfil it. Could the Minister clarify this for me?

[Baroness Thornton (Lab)]

I am very grateful to the noble Lord, Lord Patel, and the noble and learned Lord, Lord Mackay of Clashfern, for bringing these amendments to the Committee. They are quite different, although linked. On Amendment 108, which would place a duty on the Secretary of State to

“disclose information … about concerns relating to a medical device where there is a clear threat to public safety”,

the noble Lord, Lord O’Shaughnessy, absolutely got it when he said that this is not a “may” but really is a “must”. The thing about this that would interest me most, because it is an important duty, is how it could happen: what would trigger such a disclosure, where would it come from and how would it be handled?

The only thing I would ask about this issue is whether a Secretary of State is the right person to do that. I have in mind someone who is now a respected noble Lord of this House, who fed his daughter a burger to show us that beef was safe during the BSE outbreak, which led to the creation of the Food Standards Agency as an independent organisation that would say, “This food is actually unsafe”, to the Government. It quite rightly has the powers to bring about a closure or recall. This is exactly the right place to be on patient safety. The only question I would pose is: is that the right person to do it?

Amendment 114, on Regulation 3B, worries me enormously. I would need to have an explanation from the Minister as to why he would remove confidentiality and seemingly protect commercial interests. It is very worrying, and the Committee needs to know the justification for that because it looks to me like it probably needs to remain in place.

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

I understand that there was an error, and the noble Baroness, Lady Bennett, was not called, so I call her now.

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

I have received a request to speak after the Minister, so I call the noble Baroness, Lady Thornton.

[Baroness Thornton (Lab)]

My Lords, I thank the Minister for her explanation in response to Amendment 114. My desire to explore the issue slightly more is partly a result of what the noble Baroness, Lady Cumberlege, and others have said. It is also partly a result of the very helpful discussions this morning about the time that it is going to take to get the protection on devices in place. If we have another mesh situation, will that be able to emerge in this period of time? If so, who will be responsible for saying that it is not a safe device?

[Baroness Penn (Con)]

I believe that responsibility will continue to lie with the MHRA. We have existing systems, such as the yellow card reporting system. The report by my noble friend Lady Cumberlege will have made an important difference; as we discussed earlier and in other sittings, not just the systems but the culture will need to change. That culture change has begun already.

We must get the systems right so that they operate as intended and deliver the results that we all want, but the noble Baroness, Lady Thornton, is right: in the space that there will be while we implement these changes, we need to be extra vigilant about these potential issues.

As I have already said, adverse incidents involving medical devices are published on the MHRA website. The job is to take all that information and make sure that it is not just dispersed but that people can build the bigger picture. That is what we are working towards.

--- Later in debate ---

[Baroness Jolly (LD) [V]]

My Lords, Amendment 117 would establish the independent patient safety commissioner on a statutory basis, as recommended in First Do No Harm, the report of the Independent Medicines and Medical Devices Safety Review. As the noble Baroness, Lady Cumberlege, said, it is a future-facing amendment towards a proposed organisation. It has not been a surprise that all noble Lords who have spoken have been hugely supportive of her report. This recommendation from the Cumberlege review was overwhelmingly supported by the House at Second Reading and is vital to ensure that the interests of patients are represented, to try to prevent scandals such as that regarding mesh implants from recurring. We support it wholeheartedly, and I was delighted to add my name to the amendment.

At present, there is no one to listen to the voice of patients, act on concerns, gather data and put together a clear picture to report back to the department. Commissioners can bring a fresh pair of eyes to an area but also a strong voice for patients. Of course, as the noble and learned Lord, Lord Mackay of Clashfern, said, they bring independence too. In addition, they will have unique statutory powers and responsibilities, such as powers to get access to data, and investigatory powers, with power of entry if necessary. Of course, patients’ voices would need to be heard, so in all probability, there would be a helpline, as well as email access and access via a website and by letter.

The noble Baroness, Lady Cumberlege, spoke of the Children’s Commissioner, and she was not alone. It has been a great success. The commissioner knows her remit and, as the noble Lord, Lord Hunt of Kings Heath, said, she speaks with no vested interest except in children, and she stays within it. She champions children and, as has already been said, this has given her authority. As a consequence, the organisation is hugely respected.

I have heard the criticism of the cost of such a body as the patient safety commission, and I feel sure that the noble Baroness would have squared off the funding for a commissioner and their office with the Cabinet Office, which would be the funding vehicle. However, compared with similar commissions, it would amount to less than £1 per head of population per year—less than tuppence per person per week. I defy anyone to claim that that is excessive. This is indeed of value, and patients of course deserve it.

[Baroness Thornton (Lab)]

The last remark of the noble Baroness, Lady Jolly, was very pertinent indeed.

After this debate, I probably need to say only that, from these Benches, we support the noble Baroness, Lady Cumberlege, in her proposal to establish a patient safety commissioner on a statutory basis. We have heard powerful contributions from the noble Baroness, Lady Cumberlege, herself, the noble Lord, Lord Patel, and my noble friend Lord Hunt. I always thought, when I was a Minister and since, that you should always listen when the noble and learned Lord, Lord Mackay of Clashfern, says that, in his “respectful submission”, something is a good idea; it is always a good idea for the Minister to take note of that.

--- Later in debate ---

[The Deputy Chairman of Committees (Lord Russell of Liverpool) (CB)]

I have received one request to speak after the Minister. Baroness Thornton.

[Baroness Thornton (Lab)]

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

[Lord Bethell (Con)]

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