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Lords Chamber

Volume 809: debated on Tuesday 12 January 2021

House of Lords

Tuesday 12 January 2021

The House met in a hybrid proceeding.

Prayers—read by the Lord Bishop of Birmingham.

Arrangement of Business

Announcement

My Lords, the Hybrid Sitting of the House will now begin. Some Members are in the Chamber and others are participating remotely, but all Members will be treated equally. I ask all Members to respect social distancing. If the capacity of the Chamber is exceeded at any moment, I will adjourn the House immediately. Oral Questions will now commence. Please can those asking supplementary questions keep them to no longer than 30 seconds and confined to two points? I ask that Ministers’ answers are also brief.

Animal Welfare and Wildlife Crime Offences

Question

Asked by

To ask Her Majesty’s Government what plans they have to improve enforcement rates for (1) animal welfare, and (2) wildlife crime, offences.

My Lords, the Government recognise the importance of tackling wildlife crime and animal cruelty. Since 2016, Defra and the Home Office have jointly committed £300,000 a year to funding the National Wildlife Crime Unit. We have also ensured that legislation contains the necessary powers for enforcement agencies to investigate any possible offences and bring offenders to justice. The enforcement of wildlife and animal welfare laws are operational matters for the police and local authorities.

The Animal Welfare (Sentencing) Bill is important legislation with cross-party support, but it appears to be stuck. Is there a date for Committee stage and, if not, why not? On breaking the Hunting Act, particularly in light of the Hunting Office webinars now being investigated, does the Minister accept that enforcement will remain difficult until action is taken to strengthen the law and stop trail hunting being used as a cover for illegal hunting?

The Government support increasing the maximum custodial sentence for animal cruelty offences from six months to five years. We have always been clear about that. It will enable courts to take a much firmer approach to cases such as dog fighting, abuse of puppies and kittens, gross neglect of farm animals and so on. The Animal Welfare (Sentencing) Bill, which the noble Baroness mentions, was introduced into the House of Commons by Chris Loder MP and completed Second Reading on 23 October. We are currently awaiting a date for Committee. The Government have been clear that we will continue to support it as it makes its way through Parliament. We are committed to ensuring that it becomes law.

The offences that the noble Baroness cited are already offences under the Hunting Act; they are already illegal, so the issue is one of enforcement. She is right to raise them, as some troubling exposés have been made available to us but, again, crimes have been committed and it is down to the authorities to ensure that those responsible face the full force of the law.

My Lords, what steps are the Government taking to encourage the enforcement of international law in relation to wild animals? Is the Minister aware that a species called the pangolin, fully protected in theory, is being hunted in great numbers, according to that excellent organisation, the Born Free Foundation?

In 2018, the UK hosted the biggest ever illegal wildlife trade conference, and 65 countries signed up to the London declaration, which committed them to accelerating efforts to stop this vile trade. We are expanding the UK’s Illegal Wildlife Trade Challenge Fund, which has committed over £26 million to 85 projects around the world since it was launched. That includes support for the Endangered Wildlife Trust’s novel system to detect the pangolins the noble Baroness mentions in shipping containers, by using African giant pouched rats at ports in Tanzania. The UK has supported greater protections for pangolins at the CITES Conference of the Parties, which now means that all international trade in pangolins, or their parts, is prohibited. We will continue to do all we can.

My Lords, I declare an interest as a licence holder who is able to inject animals but not currently able to inject humans with the vaccine. The Covid pandemic has led to a substantial unmet need for more animal research, including on genetically modified mice. We all breathed a sigh of relief with the rapid development of vaccines, which would not have been possible without animal research. This virus affects many different organs, and there is still no substitute for animal models, which we scientists agree must be used ethically and as humanely as possible. Can the Minister reassure the House that he agrees that such research is essential for ensuring animal health and welfare, and the prevention of many human deaths?

Animal experimentation clearly has an enormously important role to play. It needs to be science-led, and there needs to be a clear understanding that the results of such research are applicable and useful in the context of human health and medicine. Broadly speaking, the Government’s view is that animal experimentation should be minimised to that absolutely necessary in pursuit of human health.

Does the Home Office plan to make wildlife crime a recordable offence, so that proper statistics can be collected, as what is measured shows what matters?

Recordable offences are set outside Defra, although Defra has been working with, for example, the Raptor Persecution Priority Delivery Group, led by police forces across England and Wales. Our view is that strong penalties are already in place for offences committed against birds of prey and other wildlife, with significant sanctions available to the courts to hand down to those convicted. Most wildlife crimes carry the risk of an unlimited fine and/or a six-month custodial sentence. However, senior government and enforcement officers have identified raptor persecution as a national wildlife crime priority, which means that greater resources will be devoted to clamping down on what we believe has been an increasing crime during the Covid period.

My Lords, in supporting my noble friend Lady Hayman of Ullock’s concern to improve enforcement rates, may I say that, as a young man, I occasionally prosecuted gamekeepers and poachers, on behalf of the RSPB, for wildlife crime offences? Will the Attorney-General review the boundaries between private prosecutions and CPS prosecutions to ensure that wrongdoing does not fall between the cracks?

The noble Lord makes an important point and I will convey it to the Attorney-General, on whose behalf I am afraid I am not able to speak. There are now over 500 wildlife crime officers, covering most police forces in England and Wales, and they are specially trained to conduct and support investigations into wildlife crimes. Defra has been supporting work led by the National Police Chiefs’ Council and the Home Office to explore widening the range of notifiable wildlife offences in respect of this question and the previous one. The benefit of doing so is that there is a national standard for the recording and counting of these offences by police forces in England and Wales.

My Lords, one of the many good things to come out of Brexit is our ability to stop the export of live animals for slaughter. I do not expect this practice to have been stopped already, but I trust that it will be as soon as possible. I would be grateful if the Minister could tell us what progress has been made to date and when we can expect to see a total ban in place.

This was a manifesto commitment and we have taken a key step in delivering it by launching, just a few weeks ago, a consultation on ending live animal exports for slaughtering and fattening, as well as further improvements to animal welfare in transport. That consultation closes on 28 January. The Secretary of State has made clear that we want to end live animal exports for slaughtering and fattening by the end of this year. We are currently considering the best legislative vehicles through which to deliver that.

My Lords, I very much welcome the decision to have the consultation on the banning of live exports of animals, but I understand that this will not apply to Northern Ireland. Will the Minister do all that he can, as someone who genuinely cares about animal welfare, to get the protocol changed to allow this much-needed consultation to happen in Northern Ireland as well? Or do the Government think that animals in Northern Ireland do not deserve the same welfare treatment as animals in the rest of the United Kingdom?

The noble Baroness makes an important point. As she says, Northern Ireland will continue to follow EU legislation on animal welfare and transport for as long as the Northern Ireland protocol is in place. But I very much take her point and I will convey it to colleagues in government.

My Lords, during the pandemic, more people are buying puppies, many of which are not bred according to our strict animal welfare standards, but are imported illegally, and separated from their mothers too early. As the price of a puppy has risen exponentially, with well over £3,000 being quoted, people are also finding that their beloved pet dogs are being stolen to order. Can the Minister say what the Government are doing to enforce the law on the sale of puppies and to discourage dog theft?

The Government introduced a ban on the commercial third-party sale of puppies and kittens in England, and ahead of that we launched a big national communications campaign strategy called Petfished, which was designed to help people make more informed choices when sourcing a new pet. These are important steps, taken to disrupt the low-welfare trade that supports unscrupulous puppy farming and to tackle the illegal supply of pets. There are already laws in place in relation to pet theft, and it is the view of the Government that the maximum penalties available are sufficient. However, I know that colleagues in government are looking at what changes could be made to sentencing guidelines to reflect the fact that a puppy being stolen is not the same as an inanimate object being stolen. I hope that progress will be made shortly.

Gas Boilers and Heaters: Replacement Programme

Question

Asked by

To ask Her Majesty’s Government what is their estimate of the total cost of replacing gas boilers and heaters in all homes in the United Kingdom; when any such replacement programme will commence; and what charges will fall on (1) individual households, (2) property owners, and (3) tenants.

My Lords, I beg leave to ask the Question standing in my name on the Order Paper. I declare my interests as set out in the register.

We are currently developing different pathways to decarbonise heat, and as such it is too soon to estimate these costs accurately. However, the climate change committee estimates that the investment required to decarbonise the entire economy and meet net zero is less than 1% of GDP until 2050. Ensuring that the costs of transition are allocated fairly is a priority, and we will publish a call for evidence on affordability and fairness by April.

My Lords, I thank the Minister for that reply. These estimates are interesting but, according to the Government’s excellent energy White Paper, there are 23 million existing homes attached to the gas supply grid. While it clearly makes sense to equip newly built homes with hydrogen or heat pumps or other technologies, is not the cost of retrofitting all existing homes—estimated by a government research paper at anything between £2,500 and £8,000, or more, per dwelling—and possibly having to replace large parts of the gas delivery grid as well, clearly going to be absolutely astronomical, whether it falls on consumers or taxpayers? Given the tiny contribution, at best, that this whole project could conceivably make to taking over all global emissions growth, is this really the wisest or most effective use of our national resources in combating worldwide climate change?

I understand the point my noble friend is making, but we do of course have a legal commitment and obligation to reach net zero emissions by 2050. Of course, 19% of total UK greenhouse gas emissions come from buildings, so we clearly need to take action in this sector. We also marry that up with an ambitious international agenda. We are hosting COP 26 this year and we will seek to persuade our international partners to follow this agenda as well.

My Lords, there are certainly home owners who live in flats on estates that were possibly originally built as social housing, with communal gas boilers and integrated estate-wide heating and hot water systems. Individual solutions will not be possible in these circumstances. Will the Minister say whether any thought is being given to such circumstances to quantify the problem and, if so, what support will be available to replace or upgrade such systems?

I point the noble Baroness to the social housing decarbonisation fund, which will deliver transformational change by upgrading a significant amount of the social housing stock that is currently below EPC up to that standard.

In recognising the Government’s desire to reduce greenhouse gas emissions throughout the United Kingdom, one must also recognise the need to ensure that the transition is fair to householders and businesses. Therefore, can the Minister tell the House what detailed study has been done to identify any additional costs there will be to run any new heating system? How can we ensure that those living in poverty will be able to bear that financial burden and keep their families warm?

The noble Lord is right that we need to make sure that the change is affordable. We have a number of schemes to help low-income families. We have the ECO scheme and the green homes grant scheme, both of which considerably incentivise low-income families to make these changes.

My Lords, may I press my noble friend on this point, bearing in mind that this will be government-enforced expenditure and will place a significant strain on many household budgets? Following this Question Time, will he discuss with the Chancellor the phasing out of all the means-testing of the winter fuel allowance and its replacement at an appropriate time with a boiler grant, especially to all those in receipt of universal credit?

We are committed to keeping the winter fuel payment to ensure that older people have the security and dignity they deserve, but we do have boiler grants, as my noble friend referred to them, through the green homes grant that are specifically designed and targeted at poorer members of society.

My Lords, I declare my interests as set out in the register. We need to ensure that green hydrogen is the predominant form of hydrogen used in the gas grid and elsewhere. To that end, what consideration have the Government given to using contracts for difference to drive down costs and encourage innovation in the production of green hydrogen, as we did so successfully for offshore wind during the coalition Government?

I understand that the noble Lord is very keen on green hydrogen and I agree with him on these points, but we are committed to consult on the preferred hydrogen business model in quarter 2 of 2021 to finalise a decision next year. Alongside this we will bring forward further details in 2021 on the revenue mechanisms that will be available to support these proposed business models.

My Lords, planning for the phasing out of all use of gas boilers is, to my mind, a very bold step, especially when the nature of the possible replacements is unclear. What steps are the Government taking to ensure that the energy and construction industries will have the capacity to cope with this change? For example, I understand that there is currently capacity to install only 30,000 heat pumps a year, whereas the need is estimated to be more than 600,000.

My noble friend makes some very good points, but the forthcoming heat and building strategy will set out the direction of travel for decarbonising heat. We are working closely with the industry to create the jobs needed to meet net zero. We recently carried out research. There will be enough skilled heat pump installers to deliver our ambitions. We recently published that supply chain research, which shows that heat pump manufacturers are able to meet a significant ramp up in demand.

My Lords, some 1.75 million boilers are installed every year. I understand that the cost of the hardware alone, using an average price, is in excess of £3 billion annually. Most manufacturers are based abroad and the profits are being sucked out of the UK economy, principally into euros. We must expect these numbers to increase dramatically as fossil fuels are abandoned. Will the Minister please explain what the Government are doing to recapture more of this huge business by encouraging British technologies and British businesses to reclaim this important and growing sector of our economy?

The noble Lord is right. We have a number of incentive schemes. I referred to the ECO scheme and the green homes grant scheme. We want to be one of the world leaders in this field and we are working with manufacturers to advance the technology to bring it down to affordable levels to enable its wide- spread use in the UK.

The recent energy White Paper stated that

“we will assess the case for encouraging, or requiring, new gas boilers to be readily convertible to hydrogen”.

Having recently experienced on 30 December the seizing up of a system boiler, I would like to know what assessment is needed for the Government to require hydrogen-ready boilers to be quoted alongside the conventional, and for the price premium for hydrogen-ready to be reduced progressively towards a conventional price if the consumer or bill payer is unaware of the requirement for all new boilers to be hydrogen-ready by 2025. Is this in the heat and building strategy that the Government are still preparing to publish?

We are supporting the development of prototype hydrogen-ready boilers that are not available at the moment through the Hy4Heat programme, which is due to conclude this year. Subject to its findings we plan to consult later this year to seek views from stakeholders on the role that hydrogen-ready appliances will play in the transition to net zero.

My Lords, the Minister referred to ground source heat pumps. How realistic are they as a green energy solution in terms of construction and cost?

They are one option. Air source heat pumps are another option and hydrogen a third. Domestic retrofit of community energy systems will also play a role. We will need to use a number of different technologies, but ground source heat pumps are certainly one possible technology.

My Lords, it is clear that retrofitting all UK homes with low-carbon heating is a long way off. Very many households will depend on heating by electricity, which is at present much more expensive than its fossil fuel alternatives. Will the Minister confirm that the Treasury’s net zero review is looking at rebalancing the cost of electricity to make it more affordable, not least for those otherwise facing deep fuel poverty?

The Treasury’s net zero review, to which the noble Lord referred, is considering how the transition to net zero will be funded. Alongside this we are publishing a call for evidence by April to begin a strategic dialogue between government, consumers and industry on affordability and fairness. We have also expanded government support schemes, which I referred to earlier, to those on low incomes, who are likely to benefit from them or to be at risk of fuel poverty. We will respond to our consultation on fuel poverty in due course.

Essential Services: Large-scale Technology

Question

Asked by

To ask Her Majesty’s Government what risk assessment they have undertaken of the reliance of (1) the economy, and (2) society, on the use of large- scale technology for the provision of essential services.

My Lords, the critical national infrastructure includes elements of infrastructure that are critical to the availability, delivery and integrity of essential services necessary for the United Kingdom to function and on which daily life depends. The CNI comprises 13 sectors, each with a lead government department responsible for identifying elements of its sector’s infrastructure.

My Lords, that was interesting. Modern technology has created amazing and beneficial things but has also resulted in a huge increase in the size and scale of operations, not least in such areas as power generation and supply, transportation networks and, of course, digital systems through the internet. It has also increased centralisation in top-down networks, where major technology or human failures may have catastrophic consequences. Do the Government agree that there must be a radical redesign of our economy and society in order to build in qualities of resilience, recovery and survival, re-engineering systems on the basis of bottom-up and modular operation at as local a level as possible?

My Lords, the noble Lord makes some important points of which the Government are aware. I refer to lead government departments and their responsibilities. They are tasked to undertake a review of all the critical national infrastructure sectors to ensure that understanding of what is critical and of risk is up to date and relevant. The review is ongoing, with each lead government department identifying the assets and systems which are essential.

My Lords, does my noble friend the Minister agree that there are huge advantages to be gained for system and state, and for local and national government, through the considered, ethical, purposeful deployment of digital and emerging technologies for the provision and transformation of essential and non-essential services?

I agree with my noble friend. In a sense, his question balances with opportunity the question of risk, to which attention was rightly drawn in the previous question. Technology brings advantages for the delivery of critical services, as my noble friend said. The rapid development of the job retention scheme, with its online portal by HMRC, is a good example of how technology can bring advantages to all levels in a time of need. However, we are also aware that there are risks associated with reliance on technology.

My Lords, in its first report last May, the National Infrastructure Commission acknowledged that security was a question not just of preventing attacks but of how well we could respond to them. It therefore recommended an architecture that would enable us to anticipate challenges and to resist, absorb and recover from attacks and adapt accordingly. Can the Minister tell the House what progress is being made on implementing that recommendation?

My Lords, the NIC made some very important recommendations, as the noble and gallant Lord quite rightly says. It is an independent executive agency of the Treasury. A responsive approach is already in place following the May 2020 report. The Government have up to a year to formally respond to the NIC’s recommendations, but I assure the noble and gallant Lord that they will be given the most careful attention.

Is the Minister aware that certain forms of technology are useful in care settings? For example, Alexa does not mind how many times someone with dementia asks the same question. Does the Minister think that the development of assisted technology—social robots alongside human care givers, perhaps—should be factored into the Government’s planning for the reform of social care?

My Lords, the noble Baroness makes a profoundly important point, which I agree with. I assure her that all the lead departments involved will consider her points. We must use the future to the benefit of all ages.

My Lords, police use of facial recognition technology can lead to a lack of transparency and accountability, as well as issues of racial and gender bias, as outlined in a recent court case. Does the Minister agree with the Surveillance Camera Commissioner that the Government need to bring forward new rules specifying exactly how, when and where facial recognition technology should be used?

My Lords, the specific question is outwith my area of responsibility, but I will pass the noble Lord’s comments on to colleagues in the Government, and I certainly note the important point that he has made.

My Lords, this is a crucial question. Cyberattacks globally on critical infrastructure appear to be increasing with impunity. What plans have the Government got to deter such attacks, particularly by foreign state actors, and have they assessed at what point such an attack could amount to an act of war?

My Lords, at my level in Government I will not comment on the final part of the noble Lord’s question. He is right that malign cyber activity, including by states, is an ongoing concern. In the Cabinet Office and across Government we are maintaining our capability to respond to major cyber incidents, and the National Cyber Security Centre and law enforcement cyber specialists are active in supporting critical organisations in the UK, including outside government.

My Lords, the Ipsos MORI research on understanding the full cost of cyber breaches, published by DCMS last year, points out that the current lack of accurate data makes it very difficult for SMEs in particular to get insurance for such events. Will the Government consider backing a cyber breach reinsurance scheme, based on the successful Pool Re and Flood Re reinsurance schemes, over this interim period?

My Lords, once again this is slightly outside my area of responsibility, but the interests of SMEs are always of great concern to the Government and I will pass the noble Lord’s suggestion on to appropriate colleagues.

My Lords, one of the biggest risks of reliance on large-scale technology is the eradication of so many traditional jobs. Would the Minister consider offering retraining to many of the people currently paid to do nothing on the excellent furlough scheme whose jobs are unlikely to have a long-term future?

My Lords, the training challenge and broader apprenticeship challenge is ongoing, immense and growing, and I agree with the importance which the noble Baroness attaches to it. The Government are helping to promote cyber skills among young people to fill the shortages in that capacity.

My Lords, controversial algorithms are increasingly being used by central and local government to make decisions. Does the Minister agree that to build and retain public trust we need strong oversight and governance of public sector use of algorithms? What response are the Government giving to the recommendations in the Centre for Data Ethics and Innovation’s recent review of bias in algorithmic decision-making, and what plans for regulation do they have?

My Lords, again, that is a very broad question, but the issues that the noble Lord addresses are extremely important and I take the sense in which he has offered it. Human judgment is, in the end, irreplaceable—your Lordships’ House could never be replaced by an algorithm.

My Lords, but does the Minister accept that some older people are denied access to vital services because of digital exclusion? Will the Government support means to help increase their access and provide an alternative way of accessing services for those who are unable to access the internet?

My Lords, the noble Lord makes a very important point. Looking at the colour of our hair, he and I should declare an interest in this matter. We need to extend understanding and use of technology, and access to it, but equally I urge all organisations, including banks, to remember that for many people a personal service is not only a matter of choice but a matter of necessity.

Cannabis Oil

Question

Asked by

To ask Her Majesty’s Government what steps they are taking to ensure that cannabis oil continues to be legally available to patients when prescribed by their physician.

My Lords, we are on the case. I completely recognise the problems faced by Alfie Dingley and all the individuals reliant on the previous arrangements with the Dutch Government for the supply of Bedrocan oils. The department is working urgently with Dutch Minister Tamara van Ark to find a solution that will enable these patients adequately to access the medications they need, and we are committed to setting up clinical trials to inform future NHS commissioning of cannabis-related medicines.

My Lords, I thank the Minister for that very encouraging response. He will know that time is of the essence because these medicines prevent children having severe fits, some of which are life-threatening. Can he go back to his department and educate some of his officials? Unfortunately, a lot of the families are very upset at being told that they can safely be switched to an alternative formulation. That is both ignorant and dangerous. All the expert clinicians who know about these issues say that that cannot be done safely. Even if it could, eventually putting these children back on to the original formulation sometimes does not work. Will he make sure that his officials listen to the clinicians who are expert in prescribing and in following the progress of people on these formulations?

My Lords, I am grateful for the noble Baroness’s kind words, and I will indeed take that patient feedback back to the department. I reassure her that this is an area where patients have undoubtedly led the way, and clinicians have to catch up. In doing so, there will need to be a meeting of minds and regulation in areas that are open to patient interpretation. In that period, there will undoubtedly need to be compromises on all sides.

My Lords, the law changed over two years ago. The then Home Secretary said:

“We have now delivered on our promises … we will work with the NHS to help support specialists in making the right prescribing decisions.”

But they have not; it has been a hollow promise for terminal brain cancer sufferers such as my nephew. NHS doctors will not prescribe medical cannabis, and the BMA advises medics not to prescribe it, yet I understand that the UK is the largest producer of medical cannabis in the world. Just how many prescriptions have been issued for unlicensed cannabis medicines, other than those subject to randomised control trials, in the last 12 months?

My Lords, the noble Baroness is being a little unfair; Health Education England published a medicinal cannabis education package on 8 August 2019. But we cannot force clinicians to make prescriptions. That is not how the health service works. We need to work on clinical trials to put in place the correct authorisations and to give marketing authorisations for these important and promising drugs. That will require collaboration between government, the regulator and industry, and I call on industry to step up to that challenge.

My Lords, some people in England and Wales are reliant on hormone therapies produced in the EU 27. Who precisely in the NHS is responsible for ensuring continuity of supply of those therapies to patients?

My Lords, procurement decisions in the NHS are done by the NHS. I do not think that a specific or unique group is focused precisely on hormone therapies, but I would be glad to go back to the department and write to the noble Baroness to confirm that.

My Lords, I draw your Lordships’ attention to my interests as set out in the register. If we can vaccinate 1.5 million people in a few weeks with a drug that did not even exist a couple of months ago, how come we cannot prescribe properly a drug that has been legal to prescribe for over two years? Cannabis contains over 120 different cannabinoids and eight terpenes, and the way in which these are configured makes a world of difference to their effectiveness. What training is being given to ensure that the right combination of cannabis oil required to treat different medical conditions is correctly prescribed? I think it is time that the Government stepped up to the plate on the training.

My Lords, I would turn around my noble friend’s proposition and ask this question. If many vaccine manufacturers can turn around clinical trials in eight months for an extremely complicated vaccine, how come the cannabis-producing companies cannot turn around clinical trials over years?

I thank the Minister for his reply. I declare that I am a cannabis user to counter pain, and no doubt later today we will be able to come back to that issue. I hope that his officials are watching to witness the support there is in this place for the role that he is trying to secure so that young sufferers who shake their brains to pieces might get relief today rather than tomorrow, when it is too late.

I thank the noble Lord for sharing that personal testimony, which is extremely touching and relevant. I share with him that there is a large amount of ministerial support for the principle of this exciting and interesting area. If there is any frustration on my behalf, it is only that somehow the industry has not matured to the point that it can sponsor the kinds of clinical trials that can take these important medicines through the necessary authorisation process that can put them on the NICE list so that they are available for more patients.

It is not surprising that people are astonished that important cannabis products, which can transform the lives of those suffering from debilitating, painful conditions, are approved yet still not available—and in some cases supply has been disrupted as a by-product of Brexit. Would the Minister care to speculate as to why this has not happened? It is not just that the companies have not stepped up—why have they not done so? Would the political will that has been brought to bear on various other issues faced by this Government, such as Brexit, not be usefully brought to bear on this one?

The noble Baroness puts a very reasonable challenge to the life sciences arrangements in the UK. We are blessed with major pharmaceutical companies, and a lively and exciting biotech industry, all of which are well plugged into the regulatory authorisation process. This is a novel, exciting, patient-led and innovative area. For those reasons, it has not had the financial backing of either business or the financial institutions to put in place the very simple, straightforward requirements of clinical trials, which are there for patient safety in the first place, not for government box-ticking. We are working extremely hard to try to resolve this Catch-22 situation and I hope very much indeed that we will be able to announce news on that shortly.

My Lords, it is nice to hear that the Government are taking this problem seriously. If these drugs are effective, would it not be a good idea to encourage the demand side of this equation, where doctors prescribe them, by pointing out what the drugs allow a child with epilepsy, for example, to do—that is, lead a normal life, get educated, get qualified and be able to have a job—and the cost to the state if they do not?

The noble Lord alludes to an important, although frustrating, point. If I may gently push back, the truth is that there is a large amount of very persuasive anecdotal evidence, some of which we have heard today. It is completely compelling—it is just not scientific. Patient safety relies on extremely rigorous clinical trial regimes; that is why we have safe medicines in the UK. It is simply not possible to persuade front-line clinicians to make prescriptions on the basis of anecdote rather than clinical study.

My Lords, I am delighted that the Minister is on the case and that we can make sure that this issue is resolved for this set of parents. On a wider note, however, would the Minister consider revisiting the NICE guidelines, last published in November 2019, which had a list of recommended research, to ensure that we potentially widen the base of research and bring more speed into the process?

The noble Baroness is right that research is the key. I reassure her that we are looking at ways to try to bring research forward. The issue is not with the NICE guidelines themselves; it is with getting the scientifically backed data to be able to justify the authorisations from the MHRA. We are working extremely closely with the NIHR. We are looking at the NHS, which, as the noble Baroness likely knows, does have manufacturing capability within itself for these kinds of drugs. As some noble Lords here will know, we are engaged in thoughts about how the NHS manufacturing capability can be used to mobilise clinical trials in this important area.

Sitting suspended.

Arrangement of Business

Announcement

Covid-19: Vaccine

Private Notice Question

Asked by

To ask Her Majesty’s Government what evidence they have that delaying a second dose of the Pfizer-BioNTech Covid-19 vaccine will not (1) diminish its effectiveness, or (2) cause further mutations in the virus.

My Lords, the views of the MHRA and the JCVI, based on the data submitted from extensive clinical trials, is very clear: a single dose gives very high protection from the virus 10 days after the first dose. A second vaccine dose is important to sustain that protection and extend its duration. Of course, it makes sense to vaccinate as many people as possible as quickly as possible to protect their lives and safeguard the NHS, which is why we take the approach that we have.

My Lords, today we are discussing the safety of medicines. Only moments ago, the Minister was emphasising just how important that is. Yet in delaying a second dose, the whole country is being treated as an experiment. Pfizer has said that the trial of the vaccine was on participants who received a second dose within three to four weeks. There is no data, it said, to demonstrate that protection after the first dose is sustained after 21 days. The WHO also says that there is no scientific evidence supporting the delay beyond six weeks. No other country is doing it. The UK is taking a gamble that risks fostering vaccine-resistant forms of the virus. Will the Minister mitigate the risks and ensure that a second dose is given at 21 days, until there is independent scientific advice and evidence for the delay?

My Lords, I remind the noble Baroness that Pfizer is not a regulator, nor is the WHO. Other countries are working on vaccines, but they are behind the UK in terms of authorisation and rollout. I reassure her that there is data, which is published on the internet. I tweeted a copy of it late last night, and I invite her to have a good, close look at it because it is absolutely categoric: one dose is enough.

There is a heated debate going on in the United States, as reported on CNN, over the incidence in use and registration of both the first and necessary second vaccinations with particular concern over the second, without which the first is less effective, despite what the Minister has just said. What plans do the Government have in the United Kingdom to ensure compliance with the necessary take-up of the second vaccination and the registration of both by the authorities?

The noble Lord is entirely right: the second dose is important. However, it is important not for efficacy but for durability. We have put in substantial data provisions to record every single dose into every single arm, and to put a follow-up dose into exactly those arms. We are using the NIMS system and every single vaccination is put into the GP record. They will be tracked down extremely diligently for exactly the reasons that the noble Lord describes.

My Lords, a number of scientists have expressed concerns about delaying the second dose of the Pfizer/BioNTech Covid vaccine. On the excellent Radio 4 programme “How to Vaccinate the World”, Professor Sir David Spiegelhalter said that, as the RNA technology used is new, there is less data to give confidence on spacing. But he suggested that, given a number of people have received their first dose, now is the perfect time to do a small randomised research trial on comparing those receiving their second dose at 21 days and others receiving it at 12 weeks, which would then perhaps give more confidence. Is that happening?

Who can hold a torch to Professor Spiegelhalter and his analysis of the data? Although I did not hear him, I completely welcome his comments. I reassure the noble Baroness that enormous efforts are being put into the pharmacovigilance around this vaccine. Some of this is of a clinical and scientific nature, and it takes a while to read out. We have therefore put in parallel systems to get an early read-out on exactly the kinds of questions that she has asked.

My Lords, as an interest, I can report that Lady Eccles and I have both had two Pfizer jabs, three weeks apart. At the planned rate of 2 million vaccinations a week, there will be the equivalent of 1 million people being fully vaccinated, whatever the gap. There will also be a continuing critical path through this rollout, which is complex. It may start by being vaccines, which are the limiting factor, but it could become otherwise. Can we be assured by my noble friend that the NHS is fully prepared to identify and deal with the critical path? Can we also be assured that we will get clear and full information on progress, and about the actions being taken to maintain that progress?

I congratulate my noble friend and Lady Eccles on their double vaccinations. It is one of the most heartening experiences of a pretty dreadful year to witness the rollout of this vaccination and the joy and reassurance it brings to those who have been vaccinated. I reassure my noble friend that the NHS is absolutely putting the resources in place not only to roll out the single and second vaccinations to everyone over 18 who will step up for those but also for the pharmacovigilance to ensure that any adverse effects are recorded through the Yellow Card scheme and that those records are analysed and acted upon so that any changes or tweaks, as sometimes happen, are enacted by the NHS to get the best possible outcome for as many people as possible.

My Lords, may I ask the Minister another question about evidence? When do the Government expect to have clear advice on the possible transmission risk from those who have been vaccinated? Everyone I know who has received the vaccine—they have been delighted to do so and impressed by the efficiency of the NHS—is now talking about meeting their Pfizered friends, seeing grandchildren and returning to volunteering or to your Lordships’ House. Does the Minister acknowledge that there will need to be cogent and clearly communicated advice for those who have been vaccinated, many of whom have been in virtual isolation for nearly a year?

The noble Baroness delivers tough news to her friends and to the Chamber, and I completely agree with her analysis. The frustrating truth is that, while the efficacy of the vaccine has been tested on hundreds of thousands in clinical trials, and we can lean on that data extremely well, the transmissibility of those who are immune is not yet clear. We have put in place trials and testing regimes to understand and get to the bottom of this point. But she is entirely right: it is possible, although not proven at the moment, that those who are themselves immune are not sterile but vectors of infection. Were they, for instance, to return to this Chamber, they would potentially infect those of us such as my noble friend Lord Parkinson, who is extremely young and does not qualify for the vaccine any time soon, and who could catch the virus off an octogenarian noble Lord in an instant.

The noble Baroness, Lady Hayman, raises the most important issue, which is communication and the way that the Government may allay anxiety. Something which has been put to me is that we know the risks to human health run by the creation of antibiotic resistance and the creation of mutant and resistant bacteria as a result of misuse, including inadequate doses. Can the noble Lord assure the House that immunologists are being consulted? What is their view of this risk? Anxieties are being expressed in many different ways, so there has to be better communication about this issue.

The noble Baroness is right that communication is key. We seek to explain the scientific basis of this vaccine, and a huge amount of effort has gone into what I call “O-level biology communications.” This is one of the reasons why acceptance rates appear to be—touch wood—as high as they are at nearly 90%. Had someone told me that number a few months ago, I would have happily settled for it. She is right, the escapology of this virus is just the same as it is under AMR. From very early analysis it would appear—and this is extremely conditional—that the recent variant is not escaping the vaccine or any of the therapeutics we have put in place. However, it is more performance enhancing. That is good news for the vaccine and bad news for the prospect of having a disease present in society and the world for some time to come.

My Lords, this virus is unchartered hostile territory and we can but rely on the best scientific advice. Some will say that delaying the second jab might even be advantageous and others will disagree. By delaying, debating and disagreeing we are going to put many thousands of lives at risk, lives which could have been saved by having that first jab. I am not qualified to say which is the best; I wish I was. I can only in gratitude accept the guidance of experts and that is what I will do. In doing so, I think that hundreds or thousands of extra lives will be saved by that first jab.

The noble Lord alludes to a complicated dilemma that we all feel. I welcome challenge and those who query and question the basis of our policy decisions and our science. He is right: too much false information and fake news can damage trust. We have gone about the vaccine process with an approach that is as open and transparent as it can possibly be. We have sought to engage in dialogue and answer questions where there have been any. That approach has proved to be effective and it is the one we continue with.

My husband, who is 84 years old, received his Pfizer vaccine before Christmas and his second one last week was cancelled. Is there any guarantee that, when the second jab comes, it will be the Pfizer vaccine? As I understand, there has been no research on mixing and matching these vaccines. Is there any way that the level of immunity can be tested at that three-month point?

The CMO has made it clear that he leans heavily towards having consistent vaccines, but it is not a requirement. Some of the immune response comes from antibodies which can be tested, but some of it is from T-cells, which are very difficult to test for. It is not possible to categorically say whether someone is immune. However, we have looked at ways to measure and understand more about the body’s immune response to develop our understanding in this area.

My Lords, what is the chance that, if the second Pfizer vaccine dose is delayed, the virus could become resistant to the vaccine? For what reason do Pfizer and the World Health Organization recommend three weeks between the vaccines?

The noble Baroness is right; this virus could mutate and start escaping the vaccine. That is a very real threat. The good news is that we know so much about it now, have digitally mapped it and have grown it so many times in the laboratory, that making new vaccines would be a relatively straight- forward process. It would not necessarily require the months of clinical trials that the first one did. However, be under no illusion, were this to happen it would set our vaccine deployment back considerably.

My Lords, I appreciate the necessity of getting as many people vaccinated as possible and the need therefore to be agile and flexible in making policy decisions. However, would the Minister agree with me and other Lords that it is also critical we win the battle of communications? We need to ensure that we take the public with us, with a clear understanding and a clarity of message.

The central proposition we are discussing is that it is better to double the number of people getting their first jab, even if there is a marginal decrease in the efficacy of the vaccine for a few people. That message has got through to the public and I think it enjoys tremendous public support. I acknowledge the concern that some will naturally feel about what appears to be a diminution in provision, but I am here to reassure and provide consistent scientific advice that is not the case.

My Lords, two logistical questions are raised by delaying second doses. First, given AstraZeneca’s statement yesterday about variability of manufacture, together with the increasing global demand going forward, how will the Government guarantee we have enough vaccines of the right type for all second doses at 12 weeks? Secondly, am I right that from the end of March the rate of new vaccinations will fall sharply, because we will then need 2 million doses per week just to cover the second doses?

I think the noble Lord has read too much into the AstraZeneca statement. Negotiations with AstraZeneca and provisions in manufacturing capacity are extremely well advanced. All the projections in the vaccine plan published yesterday have been bottomed out and secured with manufacturers and deployment. The Secretary of State was very clear about the objectives of 13.6 million by the end of February and the whole country by the autumn. Those are not vague reassurances; those are bottomed out and have business plans behind them.

My Lords, the time allowed for this Private Notice Question has elapsed. I apologise to the noble Baronesses, Lady Uddin and Lady Gardner of Parkes, that there was not time to take their questions.

Economic Update

Statement

The following Statement was made in the House of Commons on Monday 11 January.

“Before I begin, I am sure the whole House will join me in sending our very best wishes to my right honourable friend the Member for Old Bexley and Sidcup (James Brokenshire). I have been fortunate in having worked closely with him, and he is one of the nicest and most decent people in politics—a fantastic Minister and a tireless advocate for his constituents. We all look forward to his speedy recovery and to seeing him back in this place as soon as possible.

Last week, the Prime Minister set out the actions that we must take to control the spread of coronavirus. With your permission, Mr Speaker, today I will update the House on the economic situation we currently face, the action we are taking to support the British people and businesses through the crisis, and the factors influencing our outlook.

As the House knows well, coronavirus has already caused significant harm to our economy. The scale of the impact bears repeating. GDP fell by 18.8% in the second quarter of 2020. While the economy grew as the country opened up over the summer, it remained 6.7% smaller than it was before the crisis. The Office for Budget Responsibility’s November forecast showed GDP falling again in the final quarter of last year and it forecast the largest fall in annual output for over 300 years. Even with the significant economic support we have provided, more than 800,000 people have lost their jobs since February. While the new national restrictions are necessary to control the spread of the virus, they will have a further significant economic impact. We should expect the economy to get worse before it gets better.

In response, the Government have put in place a comprehensive economic plan. We have provided a fiscal stimulus of over £280 billion to fund our plan for jobs, to support public services like the NHS, and to provide financial support for millions of people and businesses. Some 1.2 million employers have furloughed almost 10 million employees. Almost 3 million people have benefited from our self-employment grants, taking the total support for the self-employed to nearly £20 billion. Over 1.4 million small and medium-sized companies have received government-backed loans worth over £68 billion. Tens of billions of pounds of tax cuts, tax deferrals and cash grants have been delivered to businesses, and the United Kingdom Government have guaranteed at least £16.8 billion of additional funding for the devolved Administrations in Scotland, Wales and Northern Ireland.

In response to the new national lockdown, we are extending and increasing our financial support. We are providing a bridge for people and businesses until the economy reopens, to give them the chance to rebuild productive capacity. To do that, we have extended the furlough scheme to April, we are supporting self-employed people with a fourth income grant, and we have announced, alongside the introduction of new restrictions, an extra £4.6 billion to protect UK jobs and businesses. All business premises in England that are legally required to close, including in retail, hospitality and leisure, can now claim one-off grants of up to £9,000 for each of their business premises, benefiting more than 600,000 businesses and coming on top of the existing grants worth up to £3,000 paid each month. We have also made discretionary funds of £500 million available for local authorities in England to support local businesses in those areas, on top of the £1.1 billion of discretionary funds that we have already provided to local councils.

Sadly, we have not been and will not be able to save every job and every business, but I am confident that our economic plan is supporting the finances of millions of people and businesses. Across almost all areas of economic policy, we are providing comparable or greater support than all our international peers. As the Office for Budget Responsibility, the Bank of England and the International Monetary Fund have all recognised, our economic response is making a difference by saving jobs, keeping businesses afloat and supporting people’s incomes.

Looking forward, there are signs of hope. First, with the vaccine, we can start to see a path out of coronavirus. Vaccine rollout is our most important economic lever and we have made available over £6 billion. We have now administered over 2.4 million vaccine doses across the United Kingdom, and by 15 February we aim to have offered a first vaccine dose to everyone in the top four priority groups identified by the Joint Committee on Vaccination and Immunisation.

Also, the data shows that there are potential sources of underlying resilience in our economy. In aggregate, we have seen the household savings ratio reach record levels and, taken as a whole, corporate sector cash buffers have improved. And of course, we have now agreed a new trading partnership with the European Union. We have removed that uncertainty from businesses and can now start to do things differently and better—not least in financial services, where in November I outlined for the House our plan to reinforce the UK’s position as a globally pre-eminent financial centre.

While the vaccine provides hope, the economy is going to get worse before it gets better. Many people are losing their jobs, businesses are struggling, and our public finances have been badly damaged and will need repair. The road ahead will be tough. Now it is time for responsible management of our economy, taking the difficult but right long-term decisions for our country, but I am confident that, with this comprehensive support that the Government are providing and, above all, the determination, enterprise and resilience of the British people, we will get through this. I commend this Statement to the House.”

My Lords, as ever I am grateful to the Minister for putting this Statement on the record and leading our scrutiny of it. The picture painted by the Chancellor yesterday was a bleak one. Given that his personal brand centres on optimism, it is clear why he has resisted appearing before the Commons until now. Before turning to yesterday’s Statement, I gently say to the Minister that announcing £4.6 billion of expenditure via a Written Ministerial Statement last week was wrong. I hope he will assure us that both Houses will receive verbal updates in future.

As outlined in the Statement, economic performance in 2020 was understandably poor by conventional standards. The Minister will doubtless disagree with me, but this was arguably exacerbated by the stop-start nature of the Government’s response to the pandemic. The outlook for the economy this year and beyond is equally worrying. Even with nifty accountancy tricks, the projections fall far short of where we would like to be. I have commented previously about the speed at which the OBR predicts annual economic growth will flatten out at an unremarkable 2%. I have regrettably seen and heard nothing from the Government which resembles a plan for addressing that concern. We recognise, as we have at all stages of the Covid-19 crisis, the colossal scale of state intervention over recent months. It has been unprecedented, but there is no doubt that challenging times call for such measures.

The Minister will know that we are fast approaching a calendar year since the first national lockdown and the launch of various economic measures that accompanied it. Despite the passage of so much time, current support still falls far short of the Chancellor’s pledge to do “whatever it takes” to help the nation through these tough times. The Government say that not every job can be saved, but more could have been rescued had Mr Sunak provided greater certainty on employment support last year rather than trying to extricate himself from it at the earliest opportunity—in the face of all available evidence. As sure as night follows day, the U-turn came, but the harm had already been done. It is ironic that he now appears to champion the furlough scheme as one of his greatest achievements.

We needed swifter intervention in the creative industries, to support hospitality firms and supply chains, and to support the aviation sector. Despite their worth to our economy, many unanswered questions remain about the future of these sectors. Ministers have shamefully refused to address well-documented shortcomings of the Self-employment Income Support Scheme, where arbitrary criteria have left millions relying on universal credit, which is already insufficiently generous and at risk of a significant cut from April. We would have accepted a declaration of intent in the event of full details not being ready; as it happens, we did not get even an acknowledgement of the problem.

The Chancellor could and should have used yesterday’s Statement to outline his plans for addressing these issues and many more, including backing local authorities rather than forcing them to raise council tax. Compliance with guidance on self-isolation is believed to be heavily influenced by an individual’s financial circumstances. The Chancellor knows this yet failed to announce new incentives to help people do the right thing. His Statement was also a missed opportunity to provide much-needed additional help for the homeless, who have, tragically and literally, been left out in the cold. Can the Minister shed any light on why these issues were not directly addressed in the Statement? Can we expect them to be addressed soon, or will the Government continue to hide behind flimsy and unsubstantiated claims?

We are trying our best to support the Government as they tackle this pandemic, and will continue to do so. However, to rebuild public confidence in their response, we need greater honesty, accountability and consistency. The arrival of multiple vaccines against this coronavirus is crucial in our fight to overcome it, but we are still getting different messages and timeframes depending on which member of the Cabinet we hear from. Whether it is in respect of the number of Covid-19 infections and deaths, the state of our economy, the struggle to end inequality or even Brexit disruption to supply chains at border crossings, Ministers warn almost daily, apparently without contrition, that things are likely to get worse before they get better.

We understand that the new strain required changes to plans over Christmas, but, as with the furlough U-turn, clarification came much too late. Despite that experience, the Government have set themselves the target of schools returning after the February half-term and life beginning to look more normal by Easter. Does the Minister stand by these dates? If it transpires that they will be missed and children will remain at home, will the Government look for additional help for teachers and a legal right for parents to request paid, flexible furlough? Can the Chancellor announce future financial support at the earliest opportunity, to give businesses and workers maximum certainty?

The Chancellor has once again responded to a long-term economic crisis with only very short-term measures. The evidence from the Resolution Foundation of sharply growing inequalities is scary, frankly, as low-income families have to spend more to survive the pandemic. Will the Government at least make permanent the £20 uplift in universal credit?

Economic recovery cannot take hold before the summer even with a successful vaccine rollout, so will the Government now extend furlough, SEISS, the loan and various other support schemes at least to July, if not beyond?

Why have the Government continued to exclude 3 million of the self-employed from help, especially now that the Federation of Small Businesses has devised a scheme that avoids the risk of fraud? The FSB has also pointed to the recapitalisation crunch that could destroy businesses in 2021. Where is the long-term economic plan for recovery that businesses need to enable them to hang in, protect jobs, invest and grow again?

My Lords, I am grateful to the noble Lord, Lord Tunnicliffe, for his comments. I shall to try to address some of his points.

It is clear that the UK, along with the rest of the world, continues to face economic disruption in the wake of the Covid pandemic. No major economy has avoided a dramatic fall in its GDP in the past year. In the face of the significant and far-reaching impact of Covid, the Government’s priority has been to protect lives and livelihoods with a flexible and adaptable response. This response is one of the largest and most comprehensive in the world, totalling more than £280 billion since March. The IMF judges the UK’s initial response as being aggressive, effective and an excellent example of well-co-ordinated action.

While we should expect the economy to get worse before it gets better, as my right honourable friend the Chancellor said yesterday, there are reasons to be cautiously optimistic for the future. The peak of the unemployment rate is expected to be significantly lower than that estimated earlier in the crisis. The OBR has revised down its central scenario from 12% in July’s estimate to 7.5% in November’s estimate. The household savings ratio has reached its highest level since records began in 1963. The corporate sector cash buffers have improved, with large businesses making large net repayments every month since May. The furlough scheme has seen some 1.2 million employers and almost 10 million employees supported and has been extended until April to provide certainty during these difficult times. We have provided significant support to the creative industries through the £1.5 billion Culture Recovery Fund and to the hospitality industry, which I recognise has been severely impacted by the restrictions. It has also been supported by cash grants, loans, VAT reductions and deferrals, and business rate holidays.

The support for the self-employed has been unprecedented and among the most generous of schemes in the world. It has so far supported almost 3 million people at a cost of nearly £20 billion. As the Chancellor has said, sadly we are not able to save every job and business and, in recognition of this, have boosted the welfare system by £7.4 billion in 2021.

I thank the noble Lord for mentioning the vaccine, which represents a significant sign of hope and a path out of the coronavirus. Vaccine rollout is our most important economic lever and we have made available more than £6 billion to facilitate that. We have now administered more than 2.4 million vaccine doses across the UK. By 15 February, we aim to have offered a first vaccine dose to everyone in the top four priority groups identified by the Joint Committee on Vaccination and Immunisation.

The road ahead remains tough, with significant uncertainties. The Chancellor and this Government will continue to work to support individuals, businesses and public services during this time. As the Chancellor said yesterday, he will provide an update on the next stage of our economic response to coronavirus and the economic outlook for the rest of the country in the Budget on 3 March.

On retaining the uplift in universal credit, referred to by the noble Baroness, Lady Kramer, as with all responses so far in the crisis, we have tried to adapt to changing circumstances and this matter will be kept under continual review. In the same vein, we have extended furlough until April, it already having been extended from an earlier time, and we will continue to be alert to the state of the economy.

On the noble Baroness’s point about the self-employed and the Federation of Small Businesses, my right honourable friend the Chancellor said yesterday that he was considering the ideas put forward by the FSB.

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

My Lords, I will quote from the Statement, where the Chancellor said:

“Across almost all areas of economic policy, we are providing comparable or greater support than all our international peers.”—[Official Report, Commons, 11/1/21; col. 23.]

We are supporting with borrowed money and using the inheritance of the country. When the Government cut back, as they inevitably will have to, they will be opposed and told that they should spend more. I will ask two questions. Do the Government have any perspective on getting back to a balanced budget? And have the Government factored in the possible impact of increases in interest rates on the amount they will have to pay back on all the money that has been borrowed?

The noble Lord asks very important questions. I am not in a position to give a date by which we will attempt to rebalance the budget, but I assure the noble Lord it is a very high priority. Indeed, on his second question, we are aware that we are able to borrow large sums of money at the moment because of the very low interest rates that will not necessarily remain, which re-emphasises the need to bring the budget back into balance as soon as possible.

My Lords, I would like to, once more—I have done so before—compliment the Chancellor and the Treasury on their general agility in their policy response to this unpredictable, ongoing and, at times, devastating twist in the pandemic. I have two very brief questions. First, in view of the highly appropriate importance being attached to the speed of the vaccination programme, and the high level of personal savings that has built up, as the Chancellor acknowledged yesterday, has the Treasury undertaken—if it has not, perhaps it might consider doing so—exploring research that directly links the speed of vaccine rollout to business and consumer confidence in an effort to encourage more people to take the vaccine and to build confidence across our society? Secondly—this links to what has already been raised—are we to believe that, once more due to the severe complications brought about by the new variant, further specific policies on the crucial levelling-up agenda, which the Prime Minister and his Cabinet frequently refer to, are likely to be delayed again, and that the planned March Budget is likely to be yet another Covid-19 support-based event?

The first question, on the link between vaccination rate and economic confidence, is absolutely fundamental. I am not aware of specific research being done on that. If there is any, I will make the noble Lord aware of it. From my own interaction with businesses, there seems to be a strong sense that the two are intertwined, which is why we are putting so much emphasis on it.

I reassure my noble friend that the commitment to levelling up remains as strong as ever. We will be making a Statement in the next few days on our progress in moving civil servants out of London and into some of the areas that the noble Lord refers to. My right honourable friend the Chief Secretary has a large fund for levelling up, for which regions can bid, and that is moving forward as well.

My Lords, the Economic Affairs Committee, of which I am a member, urged the Government in December to make the £20-a-week increase in basic universal credit permanent, as the noble Baroness, Lady Kramer, has done today. We may not be known for our footballing prowess, but the committee, chaired by the Minister’s noble friend Lord Forsyth, is hardly partisan. The Minister said that the Government were responsive to changing economic conditions, and these have only deteriorated since the committee’s report. Why does the Minister not commit now to this, thereby mitigating the deep anxiety of an inevitably increasing number of recipients, rather than prevaricate until only days before the scheduled expiry of the temporary increase?

As I said in my earlier comments to the noble Baroness, Lady Kramer, I am not able to give the commitment the noble Lord asks for. The Chancellor will give an economic update in his Budget on 3 March, and I am sure that this matter will be addressed then.

My Lords, in the self-congratulatory response of the noble Lord, Lord Agnew, he favourably mentioned the household savings ratio. As my noble friend said, this pandemic will hit poorest families hardest; they are already having their incomes squeezed, and they have no savings at all to see them through this. It is clear also that the most deprived in the UK are the least likely to self-isolate; given the current level of support, they simply cannot afford to. The poorest people in this country cannot afford to wait for a March Budget and, despite the Minister’s smug response, this Statement offers them nothing. So can the Minister explain why the Government are blind to the fact that adequately helping the poorest people in this country is not only right but vital in the national fight against Covid?

I would remind the noble Lord of the large number of interventions we have made which will substantially support the most vulnerable in society: support to renters to reduce the ability to force evictions; the mortgage holiday, which has been granted to 2.7 million people since last March; the support in the many individual programmes we have announced. All these are applicable to some of the poorest in our society. We are very aware of their vulnerability. I would gently remonstrate with the noble Lord that it was not a statement of self-congratulation when I was answering the noble Lord, Lord Tunnicliffe; it was merely a statement of what we have done over the last 10 months.

I am grateful for the much-appreciated provisions made by the Chancellor so far in this extreme crisis and for his honesty in outlining the significant harm already caused to the economy by the pandemic. Will the Minister reassure the House that, following these emergency measures, many of which have been outlined just now, there are plans and policies already being formed for a recovery? Would he indicate some of the economic and social principles that the Government will be applying in leading the recovery? In addition to the question from the noble Lord, Lord Balfe, will the inevitable need to rebalance the public finances not unfairly burden the poorest?

I have another question. Will the Minister draw on the wisdom of the Institute for Fiscal Studies Deaton review, which is seeking to understand the UK’s complex mix of unacceptable inequalities and how to alleviate them? It takes into account the hollowed-out jobs market and the need for more crucial investment in education, skills and vocational training, as our willing, talented and diverse population competes with dignity and enterprise in the global market.

The right reverend Prelate asks important questions. I can assure him that very active thinking is going on about how to come out of this awful event as quickly as possible. I will mention one or two examples. The Kickstart scheme is designed to support hundreds of thousands of newly and fully subsidised jobs for young people. By the end of December, 50,000 Kickstart jobs had already been created. Additionally, £2,000 is being paid for each new apprentice taken on. I mentioned in answer to an earlier question our levelling-up commitment and the funds behind that. Those again will go to the regions where some of the most vulnerable people in this country live.

I much appreciate many of the financial decisions the Government have taken—at very short notice, in some cases. However, will the Government, in future, have more of a mind for those businesses and people who have been most directly affected by the rules and regulations that the Government have—correctly—felt it necessary to put on to businesses, and not give relief right across the board? We have seen some large supermarkets pay back their business rates, but not all of them. That needs now to be addressed in the future, so that help goes to those who have been most directly affected and suffered the most damage. We do not need, as the leader of the Opposition said yesterday, a council tax freeze across the country, which would affect people who have not had any problems as far as the Covid crisis is concerned.

It is right that we should always aim to get the help to the most vulnerable areas, but there is a trade-off between speed of policy announcement and execution and the complexity of creating the sort of flexibility my noble friend refers to. I take on board his comments on the return of the rate rebate by supermarkets. I think a continued public programme to call out any of the larger supermarkets that have not done that will put pressure on them, as most of us are their customers.

My Lords, the Government are to be commended for their furlough schemes and economic packages to mitigate the devastating effects of the Covid pandemic. The Statement rightly acknowledges that things will probably get worse before they get better. Does the Minister agree that, in light of difficulties being experienced by our supermarkets, this applies also to possible benefits from our new economic independence—benefits taken for granted in the Statement?

I am not entirely sure what the noble Lord is referring to—perhaps to supply chain issues in the first few days of Brexit. If that is his question, I can assure him that all is being done to iron out these initial problems. Overall, the system has worked remarkably well when one considers the enormous change in operating procedures that businesses have had to bring about on an essentially cliff-edge basis.

My Lords, the Government have imposed pay freezes on public sector workers, and many others have received little or no financial support and are struggling to survive. However, they face the full and escalating costs of gas, electricity, water, broadband and even the funerals of their loved ones. What consideration have the Government given to freezing prices of these services to enable hard-pressed families to make ends meet?

I am not aware of a huge jump in inflation, as suggested by the noble Lord. Indeed, inflation remains extremely low. The pay freeze in the public sector was carefully targeted to ensure that those on the lowest earnings still received some protection.

My Lords, what the Statement does not refer to—although the noble Lord, Lord Balfe, touched on it—is the amount of debt incurred to fund government spending since the start of the pandemic. Government debt is now in excess of £2 trillion, of which nearly 50% has been bought by the Bank of England. Do the Government take the view that the Bank of England can continue to fund significant purchase of government debt, thereby avoiding damaging tax increases so long as inflation and interest rates remain low, or does the Minister think the Government would prefer to return, when they can, to cuts in public spending?

My Lords, there is a balancing act here. We all absolutely accept the grave state of the government finances following this crisis, and we will be doing everything we can to bring the books back into balance; however, if that is done too quickly, it will cause greater suffering to those who are most vulnerable, and therefore we have to try to strike a balance. The optimum way out of this will be by economic growth, which is where we are putting a great deal of emphasis.

My Lords, the £1.4 billion government-backed loan that easyJet announced yesterday demonstrates the perilous state of the aviation sector. Given that a higher tax rate does not always result in increased revenues, is it time to review the air passenger duty, partly to help stimulate demand but also partly, potentially, to increase revenues for the Exchequer?

My Lords, the Government are acutely aware of the challenging circumstances aviation is facing. The sector is able to draw on the unprecedented package of measures announced by the Chancellor, including schemes to raise capital, flexibilities with tax bills and the furlough scheme. The Government have committed to consult on aviation tax reform and will provide an update on the timing of this in due course.

My Lords, in answer to a question I asked last week in this House, I was told that the Government were looking at whether the guidance in the Culture Recovery Fund might be changed to enable freelancers to benefit directly, as many freelancers have so far received no support at all. Can the Minister say anything more about this?

My Lords, I do not have an update on the response that the noble Earl received last week, but we will of course notify the House as soon as any is issued.

My Lords, it is clear that there are gaps in support, with some groups having had no help since the first lockdown began, which can only widen inequality. What is being done to change this and when will more support for these groups be provided?

My Lords, we have used such instruments as discretionary funding support for local authorities. We have just given an additional £500 million to enable them to fill gaps, for example, in the small business community, where hardship is being experienced. We remain alert to any other pockets of the economy where we feel we may be able to assist.

My Lords, the Government’s economic measures to get through the pandemic are very welcome but, as has just been said, there are people who have been excluded and their situation needs to be addressed at a national level. In his Statement, the Chancellor also talked of the certainty for businesses as a result of the trade deal with the EU. Unfortunately, it does not look that way in Northern Ireland at the moment, where the detrimental economic effects of the Northern Ireland protocol are all too evident, as we warned. The Government must urgently come to solutions or this will have a big impact on our economic recovery, including invoking article 16 of the Northern Ireland protocol as required, to smooth the way for frictionless trade and commerce to continue between Great Britain and Northern Ireland. Can the Minister update your Lordships’ House on steps that will be taken in the coming days to fulfil the promises made by the Prime Minister on this issue?

The Government do not accept that the approach the noble Lord is suggesting is the right one. We have put in place the trader support scheme in Northern Ireland, which I had some responsibility for; some 28,000 businesses have registered for it, including more than 12,500 in Northern Ireland, and 23,000 of those are in a ready-to-trade state. Only last weekend, we managed to move 1,000 lorries across from GB into Northern Ireland; that was after the end of the in-flight concession, which was a big concession, essentially saying that goods were already in transit out of the EU at the point of delivery into Northern Ireland. That has worked smoothly. We will, of course, see problems over the next few weeks as people adjust to a very new system, but I am confident that we will be able to reduce the friction substantially over the weeks and months ahead.

My Lords, one lesson of the pandemic is that in a crisis, government bodies, from the MRHA authorising vaccines to local authorities authorising pavement cafes, can take decisions in a fraction of the time they used to. Given the importance of encouraging the growth of existing businesses and the creation of new ones, will my noble friend put pressure on all government bodies to accelerate decision-making, by requiring them to publish the times they take to make decisions and by setting times after which approval will automatically be deemed to be given?

I very strongly support my noble friend’s views on this. We have seen some remarkable decision-making across government over the last few months, at a much faster rate than normal, and I encourage my noble friend to keep up his campaign to remind people of what is possible. In my own oversight of HMRC border-readiness, I used a simple mantra, which is that it does not take any longer to make a decision than not to make a decision, and it was remarkable how quickly decisions were made. I hope very much that we can continue with that philosophy.

My Lords, I welcome the Chancellor’s timely update on our economy and the large amount of support he has given to businesses across all sectors throughout the country. As we are all too aware, we have a challenging time ahead balancing the books. Can the Minister say what steps are being taken to ensure that businesses inappropriately claiming financial assistance pay it back?

We are aware of the possibility of wrongdoing by businesses and the claiming of grants that were not legitimately theirs but, as I said on an earlier question, the priority was to get the money out quickly to the overwhelming numbers of people who deserved it. Some 1.4 million bounce-back loans were approved, worth over £43 billion; on CBILS, there were 82,000 loans worth £19 billion. There will undoubtedly have been wrongdoing in that. I assure the noble Lord that we are active in our efforts to clamp down on any wrongdoing.

My Lords, I live in the Isles of Scilly. We were very grateful for the support the Government gave to the lifeline services to the mainland in the first lockdown, but now, apparently, nothing is available to keep them going during winter. We are at risk of companies having to stop services, and we will have no freight and very few passengers. Can the Government explain why they have not given any more support to these companies? Or will they wait until they go bust, and then what will they do?

My Lords, we expect to provide over £3 billion-worth of support to local authorities over the next year, on top of the support we have already given. For example, over Christmas we provided the £1,000 Christmas support payment to wet-led pubs in tiers that were subject to lockdown. I feel the noble Lord might be being a little harsh; there has been a great deal of intervention to support local authorities and small businesses.

My Lords, I congratulate the Government and the Treasury on a remarkably quick response through very large programmes of financing. I have a simple question: we see different figures of the impact on the economy, but what was the net UK economy contraction during the calendar year 2020 and what is the forecast contraction for the calendar year 2021?

My Lords, I do not have those figures to hand, but there will be ongoing economic Statements and my right honourable friend the Chancellor will address this in his Budget in a few weeks’ time. It is perhaps worth pointing out international comparisons; the way the ONS uses data here has had a detrimental impact on how it has reported on the shrinkage of our economy, because it considers outputs instead of inputs on things such as the salaries of teachers and other civil servants, who were not necessarily working because of the crisis but were still being paid. There will be more information on this, particularly in the Budget.

My Lords, noting the expected but regrettable economic downturn, is it not excellent economic news that Unite has suspended strike action at Rolls-Royce at Barnoldswick, saving 350 jobs? Hurrah to that. But how will the Government address the challenge, talking more in UK terms rather than taking a four-separate-nations approach, of how we will unite the four kingdoms to speak with one voice on economic priorities and an implementation strategy?

I share the noble Viscount’s view that we need to talk more of a single nation. I fear we will hear more of this up to the devolved elections over the next few months, but I hope that, after that, we can get back to speaking more as a single country.

My Lords, I welcome the £4.6 billion in grants announced for the retail, hospitality and leisure sectors, as well as the sports winter survival loan package of last November, which covered 11 major spectator sports. Will my noble friend ask his colleagues to turn their attention to the community sports and recreation sector, whose clubs and community centres are currently on their knees, so that, when safe, they can be opened up as soon as possible, to enhance the physical and mental health of the nation, with at least some financial oxygen in essential life-support grants and loans?

I share the noble Lord’s concern about all these institutions that have been forced to shut down. We all very much look forward to the moment when they can reopen, which is why so much emphasis is being placed on the rapid rollout of the vaccine.

My noble friend has referred to the economic difficulties Northern Ireland will face being separated in some way from its principal single market. However, the biggest challenge we face here is that his right honourable friend the Secretary of State announced a few days ago to the world that there was no border in the Irish Sea. This provoked a response of ridicule and anger in equal measure. How can we start a recovery if our representative in the Cabinet cannot even admit the practical situation that businesspeople face every day? Can my noble friend prevail on him at least to acknowledge the realities on the ground?

My noble friend raises important points. As I mentioned earlier, we are a few days into an enormous change in how trade operates across GB and the EU, and across GB and NI, but I reiterate the Government’s absolute commitment to keep the friction between GB and NI to an absolute minimum. We are doing everything we can to do that. I ask my noble friend to bear with us, because there will be a learning process over the next few weeks.

My Lords, the night-time economy contributes, in its heyday, over £66 billion per annum in revenue and employs 8% of the workforce—a disproportionate number of whom are young people, helping motivate them and often launching them on a career. Will my noble friend look carefully at what specific long-term help can be given to all businesses in the night-time economy, not just bars, nightclubs, restaurants and street vendors but also those that advise them—marketing companies, record labels, agents, managers, PR companies, taxicabs and newsagents—to enable those which are not facing ruin in the meantime to bounce back sustainably?

The noble Baroness raises a very important point. I share her concern for this sector because, as she quite rightly says, it is not just about bars and clubs but our cultural heartland—theatres and everything that goes with it. I reassure her that this is very much on the Government’s mind and will be addressed as we come out of this crisis.

My Lords, I congratulate the Government on their rapid reactions but reiterate my concerns about relying so much on debt and QE to try to sustain growth. Given the extraordinary widening of wealth inequality entailed by QE asset purchases, disadvantaging the poorer, younger citizens, would the Government welcome the Bank the England now considering a people’s QE when creating further additional funds to boost growth directly, as well as contributing to levelling up rather than continuing to distort capital markets, undermine pension funding and help the wealthiest?

The noble Baroness will know that the Government are not in favour of a people’s QE. The QE that has happened this year has been more effective than the QE in the 2008-09 crisis; at least in this situation the money has gone directly into our economy to solve and help the problem, whereas in 2008-09, as far as anyone has ever been able to explain it to me, at least half the money left the country. We are learning, but there is a great deal of nervousness about something such as a people’s QE, because being able to print money without any comeback is almost too good to be true. Indeed, at the weekend, I bought a book by Ray Dalio on debt crises in history to try to understand more about this, because I feel we need to be very cautious about borrowing more and more money.

My Lords, the time allowed for this Statement has now elapsed. I apologise to the noble Lords, Lord Walney and Lord Holmes of Richmond, that we did not have time for their questions.

Arrangement of Business

Announcement

We now come to the Report stage of the Medicines and Medical Devices Bill. I will call Members to speak in the order listed in the annexe to today’s list. Interventions during speeches or “before the noble Lord sits down” are not permitted and uncalled speakers will not be heard. Other than the mover of an amendment or the Minister, Members may speak only once on each group. Short questions of elucidation after the Minister’s response are permitted but discouraged. A Member wishing to ask such a question, including Members in the Chamber, must email the clerk. Groupings are binding and it is not possible to degroup an amendment for separate debate. A participant who might wish to press an amendment other than the lead amendment in a group to a Division must give notice either in the debate or by emailing the clerk. Leave should be given to withdraw amendments. When putting the question, I will collect voices in the Chamber only. If a Member taking part remotely wants their voice accounted for if the Question is put, they must make this clear when speaking on a group. We will now begin.

Medicines and Medical Devices Bill

Report (1st Day)

Relevant documents: 19th and 33rd Reports from the Delegated Powers Committee, 10th Report from the Constitution Committee

Amendment 1

Moved by

1: Before Clause 1, insert the following new Clause—

“PART A1THE COMMISSIONER FOR PATIENT SAFETYEstablishment and core duties etc

(1) The Secretary of State must appoint a Commissioner for Patient Safety (referred to in this Part as “the Commissioner”) to exercise the functions set out in this Part in relation to England.(2) The Commissioner’s core duties are to—(a) promote the safety of patients with regard to the use of medicines and medical devices, and(b) promote the importance of the views of patients and other members of the public in relation to the safety of medicines and medical devices.(3) The Commissioner is not to be regarded as the servant or agent of the Crown or as enjoying any status, immunity or privilege of the Crown.(4) Schedule (Further provision about the Commissioner for Patient Safety) makes further provision about the Commissioner.”Member’s explanatory statement

This amendment inserts a new Clause which provides for the creation and core duties of a Commissioner for Patient Safety in relation to medicines and medical devices in England. The new Clause and the Schedule which it introduces would form a new Part, to appear before Part 1.

My Lords, patient safety is very much at the heart of the Bill, and while we have an enormous amount to get through this afternoon, I beg the Chamber’s forbearance if I talk in some detail about this extremely important amendment. Patient safety is the golden thread that runs through this entire Bill. Safety has been our guiding force in amendments that have made it to the Bill, from the changes to decision-making on regulatory change and the new safety lock amendment—which we will debate later—to the enforcement powers for medical devices to make clearer what the MHRA can do to take action, through to the medical devices information system.

The Government have heard the calls, including the strong cross-party support, to establish an independent patient safety commissioner for the health service in England. Of course, this was the centrepiece recommendation of the Independent Medicines and Medical Devices Safety Review helmed by my noble friend Lady Cumberlege, to whom I pay profound tribute for her tireless championing on behalf of patients. I am delighted that Amendment 1 in my name—with which it is convenient to debate Amendments 54, 65, 70 to 72, 74, 86, 87, 91, 95 and 97—delivered upon that recommendation. These amendments provide for an independent advocate to champion the safety of patients. The patient safety commissioner will promote their interests and those of other members of the public in relation to the safety of medicines and medical devices.

We acknowledge that the patient’s voice can advance safe care and system improvements but that it needs to be strengthened, as explained in my noble friend’s review published six months ago. Listening to patients is central to preventing the kinds of issues which that review brought so clearly into focus. If we do not strive to listen to patients, their families and to staff, we limit our ability to learn from mistakes, be innovative and continually improve. I pay testament to the extensive listening and the passionate advocating by my noble friend, her supporters and all patient groups.

Patient safety is a system-wide concern. It cannot be tackled by a single individual but needs to be rooted in all the branches of our health system. Good progress has been made: for example, we are improving system-wide learning through measures such as the Healthcare Safety Investigation Branch and the implementation of the 2019 NHS Patient Safety Strategy with our National Director of Patient Safety, Dr Aidan Fowler, in charge. That strategy has been listening to patients.

Staff are also encouraged and protected to speak up if they have concerns about anything they believe is harming the services their organisations deliver or commission. They are supported by the NHS People Plan, which envisages a health service that is compassionate and inclusive, not hierarchical, and where staff are listened to. The Government’s emphasis on patient safety will also be reinforced by the establishment of a new patient safety programme board. The board will take an overview—with pace and rigour—of measures and actions across the health system to improve patient safety.

The Government fully support sharpening our focus on the safety of NHS-funded services to patients and the public. We accept that the patient safety system needs to get better at identifying issues and listening to patients’ experiences of avoidable harm. Better co-ordination across and between regulators and other oversight bodies is also needed.

A patient safety commissioner will help us to champion the views of people who have been harmed by treatments provided by the health service. He or she would reinforce a culture of humility, openness and learning. The role is essentially about prioritising the insights of patients as a vital source of learning.

The Government’s amendment puts this new part of the Bill first. Amendment 1 provides for the appointment by the Secretary of State of a patient safety commissioner who is an independent statutory officeholder funded by the Department of Health and Social Care. It sets out the commissioner’s core duties, which are to promote both the safety of patients and the importance of ensuring that they are heard.

Patient engagement will be integral to the role of the commissioner. Proposed new Schedule A1 outlines the ways in which the commissioner must inform, consult and involve patients. This will ensure that patients’ concerns are being heard and that the work of the commissioner has focus and relevance for the people he or she is being set up to serve.

We have reflected carefully on the patient safety commissioner model set out by my noble friend’s comprehensive report. We agree on the importance of the commissioner’s role; it is a critical new part of the map of patient safety. But there are other areas of significant importance to the Government. The commissioner is one part of the whole system—the fundamental change that it required to tackle unsafe care and empower patients. A step change is required in how the health service transforms itself in a joined-up way to put patient safety at its core. Significantly, the introduction of the commissioner should not create overlap or confusion within that health service architecture, thereby reducing the potential to deliver patient safety improvements for patients. Indeed, my noble friend’s report rightly made it clear that the duplication of the roles of other regulatory bodies should be avoided.

In view of this, the patient safety commissioner will not act as an ombudsman. He or she will not carry out functions in pursuit of specific cases. But they can consider individual cases in their role as an overarching advocate for all patients and of making thematic and systemic recommendations. These areas are where we believe the commissioner can have greatest impact.

We have also given the patient safety commissioner deliberately intrusive powers, as called for by my noble friend Lady Cumberlege. He or she will be empowered to request and share information from relevant public authorities or a “relevant person”, meaning anyone providing health care, in relation to medicines and medical devices in England. The commissioner’s ambit will cover both the public and the independent sector.

Where my noble friend and I differ is on the process of the appointment and sponsorship of the commissioner. The patient safety commissioner will be appointed by the Secretary of State for Health and Social Care and funded by the Department of Health and Social Care. It is absolutely right that this should be the case. For example, the Secretary of State is able to initiate action on reports and understands, and has strategic oversight of, the system the commissioner is looking at.

Some noble Lords have expressed concerns about how such a commissioner might maintain their independence, but I believe that such concerns are unfounded. I am encouraged by the precedent of the Office of the Children’s Commissioner, which drew praise from several noble Lords in Grand Committee for its independence. As noble Lords know, the Children’s Commissioner is sponsored by the Department for Education and guards its independence very well. The Victims’ Commissioner does exactly the same and is sponsored by the Ministry of Justice.

It is critical—that is agreed—that the patient safety commissioner is able to speak out without fear or favour. He or she must have the powers and functions to act independently to maximise their impact and confidence. That is absolutely the case here. It is also critical that the right calibre individual with a strong voice for patients is appointed to the role. I do not think any such person would accept such a role if they felt they would in any way be constrained in that role. Nor do I think they would remain silent. Furthermore, we would expect the Secretary of State to work with the commissioner to establish how they will safe- guard and secure the commissioner’s independence. Independence is not static but an active objective, which we would expect the patient safety commissioner to be prepared to approach continuously.

The commissioner will have the power to make reports to both the public sector and independent sector, and to the Department of Health and Social Care if they so wish. Those reports are entirely independent. There is no intention—and indeed no restriction—that would allow for the Secretary of State to edit those reports. As an independent public appointee, the commissioner will also be subject to the scrutiny of Parliament, including through the Health and Social Care Select Committee.

The powers in the Bill are accompanied by a regulation-making power about the terms of office of the patient safety commissioner, the appointment of staff, and other operational matters. But while this power is exercised by the Secretary of State, we are not proposing that the Secretary of State would have any power over the commissioner regarding the fulfilment of his or her functions. However, it is right that the detail is left to regulations so that we can publicly consult on this, as we are obliged to do so under Clause 45. It is important that we get the details right. That is also why the regulations will be subject to the draft affirmative procedure.

Other amendments make minor changes to ensure that the patient safety commissioner clauses work well with the rest of the Bill.

From the First Do No Harm report by my noble friend Lady Cumberlege, to earlier, well-known inquiries and investigations, we have heard numerous harrowing stories with terrible examples of how patients have been let down badly by our most loved institutions. As noble Lords have said, now is the time to act. The Government have listened to the impassioned and compelling arguments from all sides, and I thank my esteemed colleagues for their help in shaping this amendment.

We have no doubt that restoring patient trust will be at the heart of the patient safety commissioner’s role and that he or she will advance patient safety. Our commitment to amplifying and acting on the voices of patients in our health service is paramount. To that end, I beg to move.

My Lords, I thank the Minister for his huge support throughout this whole process—all the times we have had to meet and I have met with his officials. I also thank him for the way in which he has so comprehensively introduced his amendment today. To be honest—“O ye of little faith!”—there were times when I thought the patient safety commissioner would not see the light of day. However, I underestimated my noble friend and thank him for agreeing to the concept and for bringing it to fruition with his officials.

I am very much aware of the long hours and prodigious amount of work that has gone into this amendment. I and many others are truly grateful, not least of course to my fellow parliamentarians, who have been stalwart in their support, but perhaps more importantly to all the patients and their families, who have endured the most appalling experiences over very many decades, and who have fought hard to see this day dawn.

In the report of my review, I and my small team recognised that we did not need another regulator. Many of those parts of the NHS and the healthcare system have regulators, but we did not want another regulator—we have those in plenty. We wanted something —or rather someone—new, who would be pivotal to improving patients’ safety and to prevent avoidable harm in the future. My noble friend really understands that. We need a listener, an advocate and a person of standing, who would call the healthcare system to account when needed.

In my letter to the Secretary of State, I said that the new patient safety commissioner would be the golden thread that would tie our disjointed healthcare system together for the benefit of those who matter most—the patients. I know, having listened to the Minister on many occasions and this morning, that he fully understands that. I am therefore delighted and grateful, and I thank the Government for having listened and agreed with me and my team. This new clause and the new schedule are so wonderful to see. I cannot thank my noble friend enough for his personal commitment to making this all happen. As I have said, I know a whole team has worked very hard alongside him, including other Ministers and of course his officials. I thank all of them from the bottom of my heart.

The Government’s amendments reflect crucial elements set out in our report: for example, the need for the patient safety commissioner to be independent. I hear what the Minister has said today, but we still need some reassurance on that. The patient safety commissioner cannot work or be effective if he or she is not independent. We are also very pleased that the patient safety principles underpin the commissioner’s work—that has been set out very clearly today and on other occasions—and of course, always, that patients will be closely involved in all that work. There is also an obligation on the system to respond to and co-operate with the commissioner. That is absolutely critical and is now in statute, and I thank those who enabled that to happen.

Having met so many people who have suffered avoidable harm and listened to their concerns, I know that the creation of a patient safety commissioner will mean a huge amount to them. One thing we heard so often from many them was the phrase, “Please don’t let this happen to anyone else”, a selfless plea that we should act to stop harm happening to other people in the future. Today, we are doing that. The patient safety commissioner him or herself will do just that, and I hope that will at least bring some peace of mind to those who are suffering now.

As my noble friend is aware, I have three points on which I would welcome some further reassurance. First, the importance of the role dictates that we must act as swiftly as possible to establish this role and this person in their job. The Government must of course have a credible selection process. I understand and welcome that; however, I know that my noble friend appreciates the urgency and there will be considerable pressure from patient groups and parliamentarians if we do not act at speed. This is not the time to dally. We must not risk losing the trust placed in us to get this person in post, up and running.

It is unclear to me whether the appointment of the patient safety commissioner will be independent of, and separate from, the much broader and lengthier public consultation and making of regulations. These regulations may determine some of the commissioner’s terms of office and how that person should operate. In my view, it is imperative that the two are kept separate—not least because this will facilitate the early appointment of the commissioner, who can then properly influence and shape those regulations. There is a precedent for this with the appointment of the designate domestic abuse commissioner. I see no reason for delay and would welcome my noble friend’s assurance that this appointment will be made with express urgency. I am sure the Minister will agree that we want a high-speed train, not a rumbling steam engine.

My second point concerns the definition of “relevant persons”. As I understand it, “relevant persons” will include healthcare providers in England and bodies exercising public functions relating to medicines and medical devices, but I am concerned that that does not go far enough. Other public bodies may have relevant information that could and should usefully inform the commissioner’s signal detection activities—opportunities to look wider than the norm and to scan the horizon. I include in this group, for example, the coroners’ courts, where cause of death may be found to be attributable to a medicine or medical device. I should be grateful if my noble friend could clarify whether the phrase “relevant persons” may include any public body that has information relevant to the duties of the patient safety commissioner.

I am also concerned about information of relevance to the commissioner that is held by manufacturers of medicines and medical devices. I know from my review that not all information from clinical trials, in particular, is published and shared with regulators. I should be grateful if my noble friend could reassure me that manufacturers will be required to share information and co-operate with the commissioner. Does he agree that it would be appropriate to place a duty to co-operate with the commissioner on manufacturers as a condition of selling to the UK market?

In evidence to the review, Professor Carl Heneghan repeated a question:

“Is the whole system commercially conflicted? Yes it is”,

he replied. In last week’s BMJ, Sir Cyril Chantler, vice-chairman to the review, recalled that a

“constant voice across the country was of patients telling us they felt the mesh had been commercially promoted and doctors were receiving benefits from companies prescribing it.”

Does the Minister agree that it would be appropriate to place a duty to co-operate with the commissioner on manufacturers, as a condition of selling to the UK market?

My third point concerns the following phrase in paragraph 3(3) of the Schedule:

“A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner to provide information within such period as the Commissioner may reasonably require.”

It is those five words—

“so far as reasonably practicable”—

that provide the reluctant person or organisation a get-out, not to co-operate with the commissioner. I am concerned that the words

“so far as reasonably practicable”

provide too much wriggle-room to the organisation from which the patient safety commissioner has requested information. The Freedom of Information Act requires the holder of the information to reply within 20 working days. I am not requesting anything so specific, but simply that we should not give the holder of information an opportunity to evade their responsibility when the words of the schedule require the commissioner to be reasonable in his or her request. There should be parity on that.

The commissioner must be in control. As currently drafted, it rests on the commissioner to have to challenge the relevant person’s reason for noncompliance. This could be a crucial waste of time if the information could prevent serious harm. I appreciate that the phrase exists elsewhere in legislation and its use here is not considered unusual. It is said that the commissioner should go to the lengths of naming and shaming. I do not think naming and shaming is a good solution. It is a distraction, a further waste of time and requires publicity and input from the media, which be against the commissioner’s whole raison d’être and what he or she is trying to do.

I add finally on this that those of us who were, or are employers, marvel at the fertile imagination of individuals and organisations intent on hiding some inconvenient truth, and we came across a lot of that in our review. Timely information is so important. It is crucial, because information is power, and we should not encourage a get-out in the schedule for those who still wish to hide things. It is a very small ask, but I should be grateful if my noble friend would consider omitting just those five words from the schedule prior to Third Reading.

In conclusion, it strikes me that one of the qualities of good government and good leadership, as in so many walks of life, is the willingness to listen. As we found during the review, that is not something that the healthcare system does well. When we listened to the women, they said, without fail, “Thank you for listening. You are the first people who really have listened”. This time, the Government have listened and, above all, acted. They have been inordinately patient with me and have listened to me and to my team and, more importantly, to so many people who have suffered and who want there to be a patient safety commissioner. I am truly grateful.

My Lords, I shall be extremely brief. It was a pleasure to support the noble Baroness, Lady Cumberlege, and I congratulate her on achieving a remarkable feat of getting patient safety in statute for the first time in the United Kingdom. Her tenacity was such that she was never going to give up. I also congratulate the Minister. He obviously listened and understood all the arguments that were made. He has produced the establishment of an independent patient safety commissioner. Having been concerned with patient safety for many years, it is good to know that for the first time it is in statute. The noble Baroness made a few important points that were well argued as to why words may be misinterpreted. I hope that the Minister has listened and will respond positively. Again, I congratulate her—it was a pleasure to support her.

My Lords, I, too, welcome the Government’s amendment establishing the patient safety commissioner. This is highly significant and a great tribute to the noble Baroness, Lady Cumberlege, and her team. I should also declare an interest I must declare an interest as a member of the GMC board.

The noble Baroness’s report, First Do No Harm, is a stark and moving account of how thousands of patients were let down in a serious and life-changing way. I go back to her report because she found that the healthcare system, in which she included the NHS, private providers, regulators, professional bodies, and pharmaceutical and device manufacturers, was disjointed, siloed, unresponsive and defensive. It does not adequately recognise that patients are its raison d’être. Those are telling points, which led the noble Baroness to recommend the appointment of a patient safety commissioner, an independent and proactive public leader with a statutory responsibility to champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety. That is welcome and it will be essential that the person who is appointed is robust, fearless and commands wide respect. Their independence needs to be assured. I hope also that the appointment will be subject to Select Committee scrutiny and I should be glad if the Minister can comment on that.

Picking up on a point that the noble Baroness made, I should also be grateful if I could have a little more explanation about what is meant by relevant bodies, as defined in the schedule. It is clearly important that bodies with responsibilities in relation to patient safety are expected to respond to a report or recommendation made by the commissioner. Can the Minister give a broad indication of the relevant bodies? Also, in relation to the private health sector, my reading is that this is covered by the Bill and that the schedule provides for that. Can the Minister respond?

Overall, however, I commend the Minister on the Government’s response to this significant recommendation by the noble Baroness, Lady Cumberlege.

My Lords, these amendments are a testament to the incredibly hard work and perseverance of the noble Baroness, Lady Cumberlege, the Minister and the noble Baroness, Lady Penn. They have all worked hard to get to this point. The report, First Do No Harm, must be a turning point in driving up better outcomes.

I hope that in the response to these proposals it will be helpful to have reassurance that the new post will be adequately resourced, the timeframe for fulfilling the appointment is rapid, and, subsequently, regulatory requirements can be defined and relevant statutory instruments drawn up. The independence of the post-holder is crucial. The person must be able to work across all the different and varied organisations and structures that have responsibility for patients, directly or indirectly. That will require promotion to all organisations that they have a duty to co-operate and collaborate with the commissioner to ensure that early warning signals are picked up and heeded through processes that are light on bureaucracy yet rapidly responsive in order to pick up signals. We cannot have years of accumulation of distressed patients. When things start not to be right, those amber warning lights must start flashing.

I urge the Minister to ensure that the remit of the commissioner is as wide as possible. For example, the coroners’ reports that the noble Baroness, Lady Cumberlege, referred to have not had adequate enforcement by others sometimes. The reports made powerful recommendations but it was found that those responsible for enforcing them have been so slow to act that the proposals have effectively gathered dust.

In previous debates, I raised the need for the yellow card scheme to be updated—opened for easy use by patients themselves, who may wish to report adverse outcomes. The wording of the Bill that I found most helpful and welcome is the part stating that the role

“does not prevent the Commissioner considering individual cases and drawing conclusions about them for the purpose of, or in the context of, considering a general issue”.

Can the Minister make sure that the reporting mechanisms are open to patients and do not hit a hurdle when they try to report to a clinician who does not recognise the full import of they are saying?

To conclude, I reiterate my congratulations to all, particularly the noble Baroness, Lady Cumberlege, and her team, and look forward to the next phase of working with her and others as this important development moves forwards.

My Lords, I join other noble Lords in expressing my sincere thanks to my noble friend the Minister for the progress that we have made. In all fairness to him, he said that since Second Reading he was listening, but we all know that it is sometimes possible to listen and not hear, let alone act. On this occasion, he heard and acted. I join other noble Lords in expressing my sincere gratitude for that.

I also pay tribute to my noble friend Lady Cumberlege. No one doubted her tenacity but it has been on display in bucketloads, and she has made the progress that her superb report deserves. More than anyone, I pay thanks to the army of campaigners; many of us have met them, and they could not help but move us with their stories. This legislation is ultimately for them and a tribute to them.

I had a close look at my noble friend the Minister’s amendment and compared it to that of my noble friend Lady Cumberlege. Clearly, there is a specific issue about where the organisation, the commissioner, should sit, but there is a precedent for doing that in the way in which the Minister suggested. I take confidence from his determination to give proper independence to the role. A lot will depend on the kind of person recruited, how they are recruited and to whom they are accountable. I should like him to say a little more about how he envisages that happening.

We also need to hear more detail on the timetable. The Minister will know that when one makes big commitments of this kind, they are staging posts—never the destination. There is still some way to go in making sure that we get there quickly. That is important, as my noble friend pointed out. However, the powers in the amendment are important to recognise. On the ability to demand information from relevant persons, as other noble Lords have said, we need to hear a little more about who they are and the consequences of non-compliance. However, they are powerful ways in which the commissioner can act and create change in the system. I have no doubt that they will be effective.

In conclusion, I make a couple of comments provided by the ABPI’s briefing. They relate to further questions around the nature of the relationship between the commissioner and the MHRA and other bodies, how the four nations of the UK will act together on patient safety, given that we are a single market, and ensuring diversity of patient voice.

I would also add one more thing to that. Patient safety is not just about finding out when medicines and devices go wrong; it is also about access to them. Will the patient commissioner have a remit to investigate these kinds of issues?

However, these questions are for tomorrow. Today, we want to recognise the progress that has been made and the amendments put down in the name of my noble friend. I thank him sincerely for them and I thank my noble friend Lady Cumberlege for her dedication to this particular cause.

My Lords, I, too, add my congratulations to my noble friend the Minister and pay particular tribute to the tireless work of my noble friend Lady Cumberlege in bringing us this far. I welcome government Amendments 1 and 54.

I want to take this opportunity to mention two specific issues that we focused on in Committee and seek confirmation on where we are in this regard. I want in particular to look at the right of patients to report directly on their own experience, rather than waiting for the patient safety commissioner to investigate. I would welcome hearing that my noble friend the Minister imagines that the commissioner should have this power. If not, would he consider introducing such a measure at the first available opportunity? It is so important that the voice of patients is heard. I remember the accounts that my noble friend Lady Cumberlege gave in Committee of her work and that of her team in producing the report, First Do No Harm; that will be a lasting legacy. Allowing patients the right to report directly, without necessarily waiting to be asked, would cut through many of the difficulties with medicines and medical devices, and would enable the patient safety commissioner to report directly to the Government in this regard.

The only other point that I wish to make at this stage is that of the regulations that my noble friend envisages in the government amendments in this group. Can he confirm that these will be discussed and agreed with the devolved Administrations at the earliest possible stage? Can my noble friend assure us that if the devolved Administrations raise any significant issues or highlight any problems that they have with the draft regulations, these will be acted on before the regulations are adopted and sent to each House of Parliament?

We are in a very good place. I congratulate my noble friend Lady Cumberlege and her team on bringing us here, and I pay special tribute to my noble friend the Minister for listening to the concerns of so many people, over so many years, to bring us to where we are today. I wish the amendments godspeed.

My Lords, I join the universal commendations for the Government for accepting the recommendation to introduce a patient safety commissioner. It demonstrates that campaigning can work for everybody, from school pupils to Premiership footballers to Members of the House of Lords—in this case supported by patients, many of them suffering from continuing illness and disability.

I want briefly to pick up three points made by the noble Baroness, Lady Cumberlege. The first is the importance of the commissioner being a person of standing. As the noble Baroness’s report clearly explains, there is a strong gender aspect to the fact that far too many patients have not been listened to, have been ignored and have been mistreated by the system. It is really important that the patient safety commissioner is well equipped to understand that and make themself accessible to all patients. As the noble Baroness said, it is clear that the patient safety commissioner should be a person of standing and the kind of person who should shape the role that they will ultimately fulfil.

That brings me to my second point, which the noble Baroness and many others have stressed: the urgency of this appointment. As has already been pointed out, the Domestic Abuse Commissioner has been appointed before we have even passed the Domestic Abuse Bill. That is very much a model. I have a direct question for the Minister. It should not be beyond the capacity of the department to advertise this role within, say, one month. If he does not think that this timetable is reasonable, can he suggest what he thinks a reasonable timetable is? The noble Lord, Lord O’Shaughnessy, also asked this. I also echo the point made by the noble Lord, Lord Hunt of Kings Heath, that it is crucial that this appointment has Select Committee scrutiny.

Thirdly, I very much agree with the noble Baroness, Lady Cumberlege, that naming and shaming is not the way forward. The commissioner needs to be able to get urgent action; that certainly has not worked very well with the enforcement of minimum wage legislation. The commissioner needs to be able to swing into action.

Finally, I want to pick up a point made by the Minister in his introduction. He made a comparison to the Children’s Commissioner, saying that that commissioner is also appointed by the Secretary of State and funded by the department. There is a fundamental difference between the Children’s Commissioner and a patient safety commissioner. The Children’s Commissioner has a very broad remit, of course, and has done excellent work on everything from immigration law to poverty and inequality—things that the department itself might well want to see action on, as part of bringing its entire weight to assisting children suffering so many disadvantages to get an education. But that is not quite parallel to the patient safety commissioner operating in the health department and within the NHS framework. That is where such a comparison does not quite work.

My Lords, I am delighted to follow the noble Baroness, Lady Bennett of Manor Castle.

At this stage, let me congratulate the noble Baroness, Lady Cumberlege, on her thought-provoking report, First Do No Harm, which really led to the position we are in today. I also thank the Minister—the noble Lord, Lord Bethell—for bringing forward on Report this amendment regarding the patient safety commissioner and putting it on a statutory basis. Led by the noble Baronesses, Lady Cumberlege and Lady Thornton, we have had several meetings with the Minister on this particular issue. He gave commitments in this respect, for which I, for one, am particularly grateful.

Naturally, as with everything, I have some questions, to which I and others would like some answers. On the nature of the patient safety commissioner’s appointment, how independent will they be? They will be accountable to the Secretary of State for Health and the department, but what does that level of accountability mean? What will the nature of the regulations circumscribing the appointment be? When will the appointment actually take place? What is the timeframe? Will there be adequate resources on an ongoing annual basis to fund this position, to ensure that the patient safety commissioner can act as an advocate on behalf of patients?

We have heard what the Minister had to say: that patient safety is the golden thread holding this Bill together. That is particularly important, but the patient safety commissioner will be the person who will have to provide direction and leadership. This was one of the principal aims and outcomes of the report by the noble Baroness, Lady Cumberlege, First Do No Harm. Patients who have been unwell and feel that they have been slighted or undermined in their dealings with medical practitioners want to feel safe and have confidence that they are being listened to. I hope that, whenever the regulations are published and enacted, this appointment can take place at very short notice. And, of course, the commissioner must be someone who commands respect and is a person of standing.

It is vital that the commissioner leads, with full patient group engagement and involvement, on the development of a set of principles for better patient safety that governs the way the commissioner fulfils his or her remit. I am delighted to support the government amendment. It goes without saying that I also support Amendment 65 in the name of the noble Baroness, Lady Cumberlege. There are issues with who the person is accountable to—the Department of Health, in this instance. I know that the noble Baroness was looking for the Cabinet Office, but that is just a detail. We have arrived at an important stage today, and I welcome that.

Finally, I have been talking to the Minister at the meetings organised by the department with the noble Baroness, Lady Cumberlege, to give an update on Northern Ireland, where there are several ongoing inquiries. The Minister and his officials were very helpful and are having discussions with the Minister for Health in Northern Ireland. Maybe today the Minister could provide me and your Lordships’ House with an update on the position within the Northern Ireland Executive and Department of Health.

My Lords, I am pleased to follow the noble Baroness, Lady Ritchie of Downpatrick, who asked some good questions. Indeed, many noble Lords have asked good questions about the functioning of a patient safety commissioner. All are agreed that we have come very far, very quickly, and the Minister and my noble friend Lady Cumberlege are to be congratulated on having brought this proposal from her excellent report to primary legislation so rapidly. Knowing how difficult it is, I commend the Minister and his team for securing collective agreement to such a significant policy innovation so rapidly, to the point that we can put it into the Bill on Report.

I want to make two points. First, as I know from the past, independence can be instrumental to the functioning of an organisation, but the NHS can, if one is not careful, see independence as something outside the system. It is somewhat discounted because of that. We must always think of the patient safety commissioner in two important respects. First, it should be not only independent but influential. A number of noble Lords have spoken about how that might best be achieved. That influence is terrifically important.

Secondly, patient safety is central across the NHS and is regarded as such. As the Minister and the noble Lord, Lord Patel, evidenced, we have come a long way with safety in the NHS—for example, in the reduction in healthcare-acquired infections. I was responsible for introducing never events and a range of other factors. Mainstreaming safety to become a central concern of commissioners and providers across the NHS has been a recurring feature of the work of this Government and their predecessors, and of my successors, Jeremy Hunt in particular.

I stress that that work on safety inside the NHS is clinically led and data-driven. The patient safety commissioner has a remit focused on hearing from, understanding and working with patients. That distinction is tremendously important and must be made clear to all those working across the health and care systems, from the outset. There is something new and distinctive about the patient safety commissioner, and it is not simply another accretion to the many organisations that those who work in the health system feel impede their lives. On the contrary, this is a representative of patients who, by virtue of that, attracts special attention from their point of view and brings a distinctive and unique voice into the NHS systems. I am pleased to have had this opportunity to say those few things and to support the government amendment in the name of the Minister.

My Lords, I agree with the noble Lord, Lord Lansley. It is very good news that there is to be a patient safety commissioner. I congratulate everyone who has worked so hard to create this amendment, especially the noble Baroness, Lady Cumberlege. It is so good that the Government have listened. Patient safety is vital, especially now when the NHS is under so much stress and demand. Over the years, some tragic incidents could have been avoided if patients had been listened to and there had not been cover-ups.

The noble Baroness feels that the words

“so far as reasonably practicable”

should be removed. She may feel that they would weaken the amendment; is this the case? This is important, because patients need clear information about how they are to communicate with the patient commissioner, so that they trust the system.

My Lords, I am delighted to follow my noble friend Lady Masham of Ilton. I reiterate my support given in Grand Committee for the appointment of a patient safety commissioner, and I thank both the Minister and the noble Baroness, Lady Cumberlege, for the work they have done together to get to this point.

To reflect on the speed since the report of the noble Baroness, Lady Cumberlege, I remind noble Lords of the report, in the early 1970s, called Sans Everything, about the terrible atrocities and lack of safety in some in-patient mental health services. It took nearly a decade for that to be taken seriously, so we warmly welcome the speed with which we are dealing with this situation now.

I am delighted that Amendment 54, which will be moved by the noble Lord, Lord Bethell, on behalf of the Government, will identify the principles relating to core duties, involvement of patients and amendment to primary legislation, together with regulations for appointment and operation of the office for the commissioner. I too have concerns about paragraph 3(3) of the proposed new Schedule A1, concerning the statement:

“A relevant person must, so far as reasonably practicable, comply with a request by the Commissioner”.

This means that a reluctant organisation—we need to remember that some very small organisations deliver healthcare on behalf of the NHS—or individual is potentially provided with an excuse not to co-operate with the commissioner on a reasonable request. I ask the Minister: could the words

“so far as reasonably practicable”

be removed?

Clarity over roles and responsibilities will be key to maximising patient safety, as will the independence of such a commissioner. It may well be that, as we work forward, we can be clear about the level of independence to ensure that, as they revise the principles of better patient safety, they consider not only patients in hospitals and mainstream community care but patients further afield, particularly in areas provided by the independent and charitable sector.

As other noble Lords have acknowledged, it will be necessary in any development of the commissioner for patient safety’s office to clarify roles and accountability in relation to the MHRA, and to negotiate the most appropriate approach across the four nations of the UK in relation to the commissioner.

Finally, in several briefings received on this matter it has been stressed that it will be important to ensure that the office of the commissioner, and any other associated committees or boards, reflects the diversity of our population and a range of patient experiences involving mental health and learning difficulties, as well as the physical health problems so sadly outlined in the report by the noble Baroness, Lady Cumberlege. I hope that we will also ensure that we embrace all chronological ages of our society that are served by our healthcare services. Can the Minister inform us whether these important issues of representation will be carefully considered?

My Lords, I would like to join in the praise that has been very well entitled from the many people who have spoken today, and at other times, in thanking the noble Baroness, Lady Cumberlege, and her team for the excellent report, which lies at the beginning of this development. I thank my noble friend Lord Bethell and his team for the way they have taken this forward, because I am conscious—I have tried to think about it quite a bit —of how difficult this has been. I feel that, apart from some questions that have been raised—which I do not seek to mention again as it would be useless repetition—the scheme that is involved in these amendments is very good indeed. I shall say one thing about it in a few minutes.

It is quite clear to me that safety in the NHS and in other services is an extremely important matter. When you see the amount of money that the Health Foundation pays out in respect of claims against the health service, it is fairly plain that it is a very serious problem, in fact, and one which has been found to be extremely difficult to reduce substantially. The money that goes out for these claims is a very substantial proportion of the total amount spent on the health service, so this is certainly a very important area, and it is important that it should be attended to in this way as soon as possible.

When I read the report originally, I felt that it revealed a very urgent and important problem in the health service, and that it was vital that patients should have a voice when damage emerged from a particular source, particularly where that source was in some general use. There can be no question but that this is a difficult problem and that it will take all the skill and command of the Government to produce a satisfactory and workable answer.

The report emphasises the need for principles to guide the commissioner and the wisdom of seeking the help of the public to enunciate them. I am very pleased that the Government have taken this on and that the Scottish Government have also indicated their hand to tackle this problem. Although health is devolved, it is important that, if it is at all possible, the answer to this question is agreed across the whole of the United Kingdom.

The title of the report is First Do No Harm. However, the report indicates harm having been done in a number of cases. Many treatments start with an incision and, sadly, some patients pass away on the operating table. In none of these cases do any of the practitioners involved intend to do harm. Surely this shows the calibre of the person required to take on this essential role. To enunciate the principles involved in patient care I consider to be an extremely important labour and a task demanding a person of tremendous responsibility.

I strongly support these amendments, subject to the questions that have been raised, and I am happy that they have been put forward so fully at this stage by the Government.

My Lords, the amendments in this group relate to the introduction of a commissioner for patient safety. We have supported this proposal right from the publication of the review, First Do No Harm.

At Second Reading and in Committee we supported the amendments tabled by the noble Baroness, Lady Cumberlege, to put the patient safety commissioner on a statutory basis, as recommended in the report of the Independent Medicines and Medical Devices Safety Review. I was pleased to add my name to Amendment 65, tabled by the noble Baroness, Lady Cumberlege, that we are debating. Along with all the government amendments, it will enable the progress of the commissioner’s appointment. I join others in congratulating the noble Baroness, Lady Cumberlege, and the Minister, the noble Lord, Lord Bethell, for getting the patient safety commissioner accepted so quickly by the establishment.

The critical issue is to be independent, and to be seen to be independent by example. As the noble Baroness, Lady Finlay, mentioned, both the children’s and the victims’ commissioner have remained independent, and I am sure would be useful allies and candid friends in the world of commissioners—who, as the noble Baroness, Lady Cumberlege, underlined, are not regulators.

I look forward to the time when in every NHS healthcare setting there will be easily accessible information on the role of the patient safety commissioner, and the way to contact them. We welcome the department’s commitment to working at pace, and there are many parliamentarians here today who will be keen to ensure that it does just that.

As the noble Baroness, Lady Cumberlege, said, there is a time pressure to appoint the commissioner. I join the noble Lord, Lord O’Shaughnessy, the noble Baroness, Lady Bennett, and others, in their concern for the pace of the appointment. What body will have oversight of setting up the office of the patient commissioner? I wonder whether the Minister could tell the House when he would expect the office to be up and running—in a year, in two, or more?

My Lords, I can only join in with the congratulations that everybody has expressed in this debate today. I congratulate of course the noble Baroness, Lady Cumberlege, and support her—as we have from these Benches throughout. I also congratulate and thank the Minister, the noble Baroness, Lady Penn, and also somebody who I do not think has been mentioned but I do remember sitting giving his wisdom in the many discussions we have had, who is of course the noble Earl, Lord Howe. I think the team were very wise indeed to have him sitting with them.

I am not going to say very much because I think we are there with this. Most of the questions that needed to be asked have been asked: on speed, independence, resourcing and powers, and on the issue of “relevant person”, which several noble Lords mentioned. These are the key issues.

One issue that has not been mentioned—here I thank the PSA for its brief—is the need to ensure that there is no reduction in public protection in any other areas of government policy, and that the remit of the role should link closely with the work of the other bodies involved in patient safety.

Finally, I have to say that I agree with the noble and learned Lord, Lord Mackay of Clashfern, that there has to be a four-country element in this. As the role is intended to cover only England, there should be consideration of how the link with equivalent or complementary mechanisms will work in the other countries of the UK. Otherwise, we might find ourselves with a dissonance here, which will not be in patients’ interests.

My Lords, I will save my Hollywood thank-yous for the end of the process, but profound thanks will need to be said. I want to say specific thanks to those who have spoken in the debate on these amendments. There have been a large number of very thoughtful comments. The noble Baroness, Lady Thornton, and my noble and learned friend Lord Mackay both mentioned four nations and devolution. The noble Baroness, Lady Bennett, spoke on gender, my noble friend Lord O’Shaughnessy on industry advocacy, and the noble Baroness, Lady Ritchie, on Northern Ireland. It is a very long list, and I cannot address every contribution. What I will do instead is address what I think have been the key points in the debate on these very important amendments.

Amendment 65 was tabled by my noble friend Lady Cumberlege before the Government’s own. I am extremely grateful to her and her team, who have written to me expressing their thoughts. The government amendment would not have been possible without her continued engagement and that of other noble Lords whose experience and knowledge have been essential in shaping the Government’s thinking. Although there are differences between our amendments, we are agreed on the fundamental point that we must create a patient safety commissioner in order to give the voice of patients its rightful prominence. My noble friend Lord O’Shaughnessy has made that point extremely clearly and effectively.

More broadly, I hope that the amendment in my name assures my noble friend Lady Cumberlege and the House of the seriousness with which the Government takes the report First Do No Harm. The Government will continue to review this report. We made a Written Ministerial Statement on the report and its recommendations yesterday, and will respond to the whole report shortly.

A patient safety commissioner, as proposed in Amendment 65, would promote the interests of patients and other members of the public in relation to the safety of medicines and medical devices. The Government entirely agree that listening to patients is essential to preventing the sorts of issues highlighted in the report. On this, our visions for the patient safety commissioner are as one.

However, Amendment 65 in the name of my noble friend Lady Cumberlege differs in specific ways. Her proposed new subsection (2) provides that the Cabinet Office would host and fund the patient safety commissioner. My noble friend has argued here and in Committee—and, indeed, in her report—that this would be necessary to safeguard the independence of the commissioner. I simply do not agree. It is common practice for commissioners to be sponsored by the government department with relevant policy responsibility, and it is entirely unclear to me what the benefit of sponsorship elsewhere would be. The process of public appointments is set out clearly; there is no question of undue influence by the sponsoring Secretary of State. The process is there—in fact, it is public. Nor does the identity of the sponsoring department amend or change the powers and functions of the commissioner; it is simply how the body is supported.

There are also differences in the way in which my noble friend’s intention is executed. In her report, she was clear that working with other bodies was necessary and, as I would hope, obvious as part of any commissioner’s remit. However, Amendment 65 is unclear as to how the commissioner would interact with other regulatory bodies. For example, proposed new subsection (5)(e) would allow the commissioner to receive direct reports from patients and any other persons, including regulators and the public. However, the CQC, the Parliamentary and Health Service Ombudsman and the MHRA, among others, are all open to receiving direct reports from patients and the public. They have a responsibility to listen to complainants. These bodies also have their own routes for reporting. For example, as we know from the vaccines rollout, adverse incidents relating to medicines and medical devices are reported through the MHRA’s yellow card scheme.

Without differentiation between taking receipt of direct reports to further a broader investigation and acting as an ombudsman, Amendment 65 might create a body overwhelmed by patient reporting and investigating individual cases. The noble Lords, Lord Patel and Lord Hunt, both referred to past agencies here, but where the best route to resolution sits elsewhere. The report itself said that the commissioner should not investigate individual cases, yet this boundary is absent from the amendment.

Proposed new subsection (7) enables the commissioner to require information from public bodies and others for the purposes of producing and laying before Parliament reports regarding patient safety, but “other” would extend to private individuals—a very expansive group indeed. The amendment tabled by my noble friend provides for the commissioner to make reports only to the Secretary of State and Parliament, and not to a range of bodies as in the government amendment. Nor does my noble friend’s amendment provide for what would happen if these individuals did not respond.

“Relevant person” is a broad definition. I am confident that it will enable the commissioner to engage with the organisations necessary to fulfil their functions effectively. In addition, proposed new paragraph 3(1)(b) of Schedule A1 would enable the commissioner to receive information from and consult

“any other person the Commissioner thinks appropriate”.

This provides the commissioner with all the relevant tools necessary. A vital difference between my amendment and the proposals of my noble friend is that, in mine, provisions are made for the patient safety commissioner to make reports and recommendations to relevant public authorities or persons, and for that authority or person to have a duty to respond to these; I think that is vital.

We have listened, and made substantial changes in this area since Second Reading, so I signal to my noble friend that I do not anticipate debating any amendments at Third Reading.

My noble friend has raised the issue as to whether the words “reasonably practicable” are a fetter on the commissioner, saying that they might prevent the commissioner obtaining information. To this I would say that the language used in our amendment is exactly—or almost exactly—as it is for the Children’s Commissioner and the Domestic Abuse Commissioner. They are no different. “So far as reasonably practicable” provides for circumstances where a body is asked for information it simply does not hold, or, say, information is requested to be sent via email when the information held cannot be transferred from one IT system to another. Without the words “so far as reasonably practicable” there is no means to be compliant. It is fair to have that language in there. Such language reflects that the commissioner may ask for the impossible or the undeliverable, but it is not a shut door. We would expect that a refusal on the basis that it is not reasonably practicable to comply would open up a dialogue on what was practicable.

However, the commissioner is armed with tools for additional action if met with non-compliance. The commissioner could, for example, bring that non-compliance to the attention of the body’s regulator, the Secretary of State or Parliament. In a system that can sometimes seem crowded, it is essential that each organisation is able to work in a way that is complementary, so that the system becomes greater than the sum of its parts.

I hope my noble friend can acknowledge that we differ here on very few matters. We discussed this in Committee and had conversations after that. The Government’s position on this has not changed and our view will not change between now and Third Reading. I therefore hope that my noble friend will not feel that she has to push her amendment. If she wishes to test the opinion of the House, she should do so now.

I have received one request to ask a short question. I call the noble Baroness, Lady Cumberlege, to ask a short question for elucidation.

My Lords, I want to say one or two things very quickly. I thank those who have spoken; it has meant such a lot to me. The noble Baroness, Lady Jolly, and the noble Lords, Lord Patel and Lord Hunt, have been there since the very beginning of this journey.

I say to the Minister, as I should have said at the very beginning, that I will withdraw my amendment. I have no wish to take it further. I do think that the Cabinet Office would have provided us with more independence, but my noble friend the Minister said at the very beginning that this was a red line and it was no good my pursuing it. I took that hint and I have not argued it anywhere. Hearing the Minister talk about independence today—getting it on the record—has been really important. However, as the noble Lord, Lord Lansley, said, of course influence matters as well, and I take that.

I will say a very quick word about the timetable, which is critical. In our recommendations we wanted to set up a task force to implement this under the aegis of the Department of Health and Social Care. That has been rejected by Ministers. That is a tremendous pity. Noble Peers are concerned about the timetable; so am I.

It has been said that this has been very quick. No, it has not. Those of us who have run companies know what “quick” means: if your company is to survive you have to act very quickly. This is not quick. I will put pressure on through other means, particularly the all-party group, to get this implemented as soon as possible, because people are suffering. People are in dire straits and we have to stop this awful damage that is being done to lives. The quicker we can do this, the better. I am sure my noble friend will agree with that.

I know when I am beaten, but I also know what needs to be done. I do not want to go through the point of view of the Cabinet Office, but it is absolutely critical that this appointment is made speedily, because people are suffering and we should avoid that if at all possible. I believe that the patient safety commissioner will grasp this issue and ensure safety, which, as my noble friend the Minister said, has run through the Bill. I thank him for that, but it will not happen until this appointment is made. I am afraid that I will press very strongly on that.

I thank all noble Lords for taking part. I wish I could go through this in detail, but it is not my remit to do so. I thank noble Lords so much for their support.

I thank my noble friend for her very kind and generous words, and for making it clear that she will not move her amendment. I reassure all noble Lords that their words are on record and will have a bearing and influence on the development of the patient safety commissioner as it is rolled out.

My noble friend’s question was about timing and speed. I hear her admonishments loud and clear. She knows that once we have committed to something we will deliver it. I ask for her forbearance. There is a global pandemic on. I cannot guarantee that this is the number one priority because we need to do the vaccine and we have to get Britain back on its feet. Those are distractions that I cannot hide from the House, but I reassure my noble friend and all those involved in the debate that a commitment has been made very clearly and we are now moving to deliver it.

Amendment 1 agreed.

We now come to the group beginning with Amendment 2. I remind noble Lords that Members other than the mover and the Minister may speak only once and that short questions of elucidation are discouraged. Anyone wishing to press this or anything else in the group to a Division must make that clear in the debate.

Clause 1: Power to make regulations about human medicines

Amendment 2

Moved by

2: Clause 1, page 1, line 8, at end insert “for a period of three years beginning with the day on which this Act is passed.”

Member’s explanatory statement

This amendment provides a sunset provision for Part 1 of the Bill requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 2 and 3 of the Bill, and the amendments in the name of Lord Patel requiring consolidated legislation.

My Lords, in moving Amendment 2 I will speak also to Amendments 27 and 40 in my name. I also support the amendments in the names of the noble Lords, Lord Patel and Lord Kakkar, and of the noble and learned Lord, Lord Mackay.

This amendment would provide a sunset provision for Part 1, requiring the Government to return with primary legislation. It is linked to the sunset amendments for Parts 2 and 3 and the amendments in the name of the Lord, Lord Patel, requiring consolidated legislation. We discussed all these issues in Committee. Through discussion, the noble Lord, Lord Patel, the noble Baroness, Lady Jolly, and others have joined together to put this together as a suite of amendments, which makes sense.

At Second Reading, the noble Lord, Lord Blencathra, said:

“Thus it grieves me to say that the structure of the Bill is absolutely atrocious and an affront to parliamentary democracy. Of course, it is not unique; it is just one more Bill stuffed full of Henry VIII clauses but devoid of substantive content. It is the barest skeleton, all to be filled in with negative secondary legislation.

I am speaking in my capacity as chair of the Delegated Powers Committee. We considered the key clauses—Clauses 1, 8 and 12—and concluded that they contain inappropriate delegations of power. We say that

‘the Government have failed to provide sufficient justification for … the Bill adopting a “skeleton bill” approach, with Ministers given very wide powers to almost completely re-write … regulatory regimes’.”—[Official Report, 2/9/20; col. 415.]

Here we are some distance away from that remark. Indeed, the question we must ask is: have we succeeded? Is the Bill less atrocious now than at the beginning when the DPC was so scathing?

All of us, in particular the Minister, the noble Baroness, Lady Penn, and the Bill team, have listened and improved the Bill. The Government have worked hard to meet some if not all of the Constitution Committee’s and the Delegated Powers Committee’s recommendations.

We believe that this suite of amendments, in a way, builds on those improvements that have already been made to the Bill. They propose a very simple objective that was articulated from the very beginning. It is neither democratic nor safe to run medicines, devices and veterinary medicines through regulation alone in the long run. Our regulatory framework needs to be in primary legislation. This must be achieved in a timely fashion, hence these amendments. Sooner or later—and there is agreement on this—there will need to be consolidation in primary legislation. We would prefer it to be sooner. We think that some agreement is necessary on this.

While I recognise the need to get this legislation on the statute book, the Minister must know about the disquiet that some of this has caused and the need to address the issues of accountability in regulation. The truth is that while we are very pleased to now have affirmative regulation, it is very rare for that to be rejected once it reaches Parliament, however unsatisfactory it might be. In fact, we have learned a great deal about regulation over this year of Covid regs.

The amendments in my name and those of the noble Lord, Lord Patel, and the noble Baroness, Lady Jolly, would amend Parts 1, 9 and 14, which concern the three objectives of the regulation of medicine, medical devices and veterinary devices, with a three-year sunset provision. In Committee, I proposed that there should be consolidation of regulatory legislation within a two-year period, so I hope the Minister might recognise that we have been quite generous here because we have now extended that to three years.

Other noble Lords who are much better qualified than I will discuss the merits of the group. I look forward to hearing their discussion. In the meantime, I beg to move.

My Lords, I support the amendments in the name of the noble Baroness, Lady Thornton. As she said, they should be read in conjunction with my Amendments 26, 39 and 63 on the need for consolidating legislation, which I will come to in a minute.

As has previously been debated, the Bill confers an extensive range of delegated powers relating to medicines, veterinary medicines and medical devices. Previously, the power to create relevant secondary legislation in the UK was derived from the European Communities Act 1972. Those delegated powers were simply to allow the implementation of laws in the UK that have already been consulted on, debated and scrutinised at EU level and by our own EU committees in the Lords.

The powers in the Bill are such that areas of policy that previously would have been subject to greater scrutiny at EU level may now be amended without similar levels of scrutiny in the United Kingdom. They do not, as such, represent an equivalent conferral of power to the legislature seen under the previous regulatory arrangements.

As has been mentioned, the House of Lords Constitution Committee recommended that, although delegated powers are appropriate to make provision for minor and technical matters, it is essential that primary legislation is used to legislate for policy and other major objectives. The risk of delegated powers that provide significant flexibility is that substantial policies are amended, and not merely implemented, by secondary legislation. That was also emphasised in the report of the Delegated Powers and Regulatory Reform Committee, which concluded that the Bill represents an unjustified delegation of power. I admit that the Government state that the Bill is intended to be primary legislation and they have brought in amendments to improve it, but, although amendments in Committee increased the scrutiny that these powers will be subject to, they still cover wide areas of policy that should properly be the subject of primary legislation.

As the Bill stands, the delegated powers conferred would allow the Government to make substantial policy changes in these areas through secondary legislation as a matter of course into the indefinite future. These powers conferred by the Bill go far beyond what is either necessary or prudent, and for that reason there should be a time limit on them. Therefore, I support this amendment.

Before speaking to my own amendments, I thank the noble and learned Lord, Lord Mackay of Clashfern, the noble Baronesses, Lady Thornton and Lady Jolly, and the noble Lord, Lord Kakkar, for putting their names to them. My amendments would require draft consolidated legislation for human medicines, veterinary medicines and medical devices. Together, the new clauses that I propose and the other, related amendments would require the Secretary of State to publish draft consolidated legislation within three years. I realise that that is a tall order, and there might be some discussion about the period required to streamline the existing regulatory framework.

As I said, these amendments are linked to the one moved by the noble Baroness, Lady Thornton, providing for the three-year sunset provision. They would create an obligation to draft primary consolidating legislation in respect of human medicines, veterinary medicines and medical devices and are intended to be read together. The need for clauses requiring consolidated legislation is inextricably tied to the time-limiting of powers conferred by the Bill, as primary legislation will still be needed to form the basis of the regulatory regimes in these areas.

Of equal concern is that the existing regulatory regimes for medicines and medical devices are complex and unwieldy, spanning multiple pieces of primary and secondary legislation that implement several EU directives. This existing complexity has only been added to by several more pieces of secondary legislation in these areas, implemented in preparation for Brexit.

In Committee, I tabulated at length—it ran to a couple of pages—the different regulations that have been brought in, since the early days, because of the directives and regulations. For example, currently the regulatory regime for medical devices consists of the Medical Devices Regulations 2002, which implemented three different EU directives, and the Medical Devices (Amendment etc.) (Exit) Regulations 2019. The 2019 regulations were intended to ensure that the existing Medical Devices Regulations continued to operate correctly once we left the EU, but then other regulations were added to it. Those are examples of how many different regulations there are and, therefore, of the need for consolidation.

In addition to those uncertainties, in the final months of 2020 several new statutory instruments were laid before Parliament setting out complex new systems of regulation for medicines and medical devices as between Northern Ireland and the rest of the UK. The situation with Northern Ireland greatly adds to the complexity of regulation and has implications that we are only just beginning to understand. This matter should be of prime consideration. Once the shape of relations with the EU becomes more apparent, clarifying this complex relationship will become a priority for stakeholders and patients alike.

As it stands, the Bill merely grants powers to create future regulations through statutory instruments, simply adding to the existing regulatory complexity. Not consolidating or clarifying any of these issues could lead to further uncertainty among stakeholders about their obligations. This demonstrates the need both to time-limit these delegated powers and to ensure that consolidating primary legislation is introduced to Parliament after three years—although, as I said, I recognise that it might take longer—in order to subject any policy changes to adequate scrutiny.

The lack of detail in the Bill and the broad delegation of powers, with no indication of the substantial content of future regulations created by them, provide no clear or certain path ahead for regulations covering medicines and medical devices to be either scrutinised or relied on by stakeholders. For those reasons, these amendments and those linked to the amendment moved by the noble Baroness, Lady Thornton, will limit the extent of these broad delegated powers and require the Government to return with consolidated legislation in respect of human medicines.

My Lords, I strongly support the amendments dealing with consolidation. I regard it as very important that the legislation that controls medicines, medical devices and veterinary medicines is consolidated in a way that makes it possible for an interested person easily to achieve knowledge of the regulations. After all, when you think of how important medicine is—we have just had a considerable debate about its safety—it is important to make sure that those who administer and operate the system know the rules. If you do not know what the rules are, the chances are that you will be misled into thinking that you know when you do not know at all. Therefore, it is important to make sure that we do everything we can to lay before those who practise these arts the true rule that has been set down, and it should be possible for them to reach it without too much research into a number of statutory instruments.

We just need to think for a moment about the current virus regulations. I have had occasion to look at them from time to time, and it is quite difficult to follow what is required at a particular moment in England, Scotland or other parts of the United Kingdom. If that is the position in relation to the virus, it is obvious that the general position in relation to these sciences as a whole will be even more difficult. Therefore, I regard it as vital—indeed, as a fundamental duty of government—to ensure that the regulations on these important matters are clear and the rules accessible.

I am not very keen on the sunset clause because, if it operated without consolidation, we would be in a pretty difficult position. Therefore, I regard it as vital to require consolidation.

I am aware of the difficulty of consolidation. For a short time, I was the chairman of the committee on consolidation and, when it sat, it was extremely difficult to get a quorum because people did not find the exercise interesting. But unfortunately, although it might not be very interesting or novel, in the sense that you are not doing anything very new, it is absolutely vital to allow the system to work properly. So I regard it as important that that is put into the statute as an obligation. If we are allowing the Government to legislate in these important areas by statutory instrument —the criticism has been levelled that they are doing so too much—that should be replaced in a reasonable time. Three years is probably quite reasonable, but I am very willing to hear whatever is said about that. I regard it as very important that this is an obligation on the Government as a condition of getting away with this method of legislating quickly in this area.

My Lords, it is a pleasure to speak in support of Amendments 29, 36 and 63 in the name of my noble friend Lord Patel, to which I have added my name, and broadly for the principles of the other amendments in this group. This is a critical area of public policy, as we have heard in this debate and in the excellent debates on these questions in Grand Committee. We have also heard that the regulations—the legislation attending medicines, medical devices and veterinary medicines, and their regulation in our country —have appeared on the statute book as a result of facilitations through the European Communities Act 1972. These represent in many ways a haphazard patchwork of regulation, created over time, with good intention, but obviously with the need to be consolidated and brought to a clear and precise place, as we heard from the noble and learned Lord, Lord Mackay of Clashfern, in such a way that any party interested in this vital area, which impacts on the lives of every citizen, can do so with simplicity, understanding obligations, understanding their rights and protections and being able to act confidently with regard to the rule of law.

The current regulations represent a challenge, and as a result of our departure from the European Union, there remains much contemporary regulation, agreed at the European level, with specific reference to clinical trials and medical devices, that has yet to be incorporated into domestic legislation, once again representing an important challenge with regard to the framework within which we are to proceed.

The Government rightly have stated that patient safety is at the forefront of their thinking when it comes to regulations regarding medicines and medical devices. To bring clarity will improve safety and will also achieve the Government’s other stated objective of ensuring that our country can continue to lead globally in the life sciences. We have seen the benefits of that leadership during the Covid pandemic, in terms of innovation, the application at scale and pace of that innovation for the benefit of our citizens, and the sharing of that knowledge globally.

Therefore, it is difficult to understand why Her Majesty’s Government would reject the opportunity to commit to consolidating legislation so that simplified, clear, effective and intuitive regulatory regimes exist in our country and can deliver the objectives that we all agree upon. In Grand Committee, we heard from the noble Lord, Lord Lansley, an interesting proposition that the Law Commission might be approached to support the task of consolidating legislation in this area of public policy. We have heard from the noble and learned Lord, Lord Mackay of Clashfern, that when he chaired a committee of consolidation there was little interest in dealing with some of the more demanding and exacting elements with the fastidious nature that is required to create effective consolidated primary legislation. Has the Minister had an opportunity to explore whether the Law Commission might be approached on the basis of the Law Commissions Act 1965, to determine whether it would be in a position to propose and engage with the consolidation of legislation regarding medicines, medical devices and veterinary medicines, as part of its forthcoming 14th programme under the obligations and opportunities afforded by the Law Commissions Act?

A failure to do this would be a lost opportunity. There is strong support for this Bill and a recognition that it must be passed in its current fashion as rapidly as possible. However, there is also a strong recognition that many of the issues are tied up in long-standing regulation created over a period of time, without the clarity and benefit of understanding the opportunities and risks offered by modern medical practice and innovation in healthcare. Not to consolidate would put our country behind rather than at the forefront of t